Flexible circuit electrode for lasso catheter

Abstract

An electrode assembly for a medical device may include a flexible substrate extending along a plane and a plurality of electrical leads extending along at least a portion of the flexible substrate. The electrode assembly may also include a plurality of electrodes disposed on the flexible substrate. Each electrode of the plurality of electrodes is electrically connectable to at least one electrical lead of the plurality of electrical leads. The plurality of electrodes may be positioned on the flexible substrate such that when the electrode assembly is wound around an end effector member wound about a longitudinal axis to define a lasso catheter, at least some of the plurality of electrodes are positioned on a side of the lasso catheter away from the longitudinal axis extending through the lasso catheter.

Description

Technical Field

[0001] The present invention relates generally to medical devices, and in particular to lasso catheters having improved flexibility and electrode placement. Background Art

[0002] Arrhythmias, such as atrial fibrillation (AF), occur when an area of ​​cardiac tissue abnormally conducts electrical signals to adjacent tissue. This disrupts the normal cardiac cycle and causes an irregular heartbeat. Certain procedures are used to treat arrhythmias, including surgically disrupting the source of the signal that causes the arrhythmia and disrupting the conduction pathways used for such signals. A mapping catheter can be used to map the electrical signals propagating through the heart, and then only selected areas of the tissue can be ablated to treat AF. By selectively ablating cardiac tissue by applying energy via a catheter, it is sometimes possible to stop or change the propagation of unwanted electrical signals from one part of the heart to another. Medical probes can use radio frequency (RF) electrical energy to heat tissue. Some ablation methods use irreversible electroporation (IRE) to ablate cardiac tissue using non-thermal ablation methods.

[0003] Pulmonary vein isolation is a procedure commonly used to treat AF. Physicians typically use a lasso catheter that includes multiple ring electrodes that are clamped or otherwise attached to the spine of the lasso catheter. However, these ring electrodes are not configured to simultaneously measure electroanatomical signals of the tissue and electrical signals propagated through the surrounding blood, which can reduce the effectiveness of the mapping operation and lead to unnecessary increases in the total procedure time. In addition, 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. Therefore, there is a need in the art for a device that is configured to reduce the total procedure time by completing multiple elements of a mapping procedure using a single device that can perform multiple functions simultaneously and is suitable for a range of sizes. This and other problems can be solved by the technology disclosed herein. Summary of the invention

[0004] The disclosed technology includes an electrode assembly for a medical device. The electrode assembly may include a flexible substrate extending along a plane. The electrode assembly may also include a plurality of electrical leads extending along at least a portion of the flexible substrate. The electrode assembly may also 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 positioned on the flexible substrate such that when the electrode assembly is wound around an end effector member wound around a longitudinal axis to define a lasso catheter, at least some of the plurality of electrodes are positioned on a side of the lasso catheter away from the longitudinal axis extending through the lasso catheter.

[0005] The disclosed technology may include a medical probe including an insertion tube extending along a longitudinal axis. The medical probe may also 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 approximately 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 also include a plurality of electrodes disposed on the flexible substrate. Each of the plurality of electrodes may be electrically connected to at least one of the plurality of electrical leads. The plurality of electrodes may surround the spine member. At least some of the plurality of electrodes may be positioned away from the longitudinal axis.

[0006] The disclosed technology may also include a method of manufacturing a medical probe. The method may include forming the spine into a generally circular shape. The method may also include spirally winding the spine with an electrode assembly. 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 also 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 positioned on the flexible substrate such that when the electrode assembly is spirally wound around the spine, at least some of the plurality of electrodes may be positioned away from the 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 accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1 is a schematic illustration of a medical system including a medical probe having an end effector with electrodes according to an embodiment of the disclosed technology;

[0008] Figure 2A is a bottom perspective view of an end effector for a medical probe according to the disclosed technology;

[0009] Figure 2B is a top perspective view of an end effector for a medical probe according to the disclosed technology;

[0010] Figure 2C is a side view of an end effector for a medical probe according to the disclosed technology;

[0011] Figure 2D is a top view of an end effector for a medical probe according to the disclosed technology;

[0012] Figure 3 is a side view of a spine member rolled into a flexible substrate according to the disclosed technology;

[0013] Figure 4According to the disclosed technology Figure 3 A cross-sectional view of the spine member of the medical probe taken along line XX;

[0014] Figure 5A is a top view of a flexible substrate having a plurality of electrodes according to the disclosed technology;

[0015] Figure 5B According to the disclosed technology Figure 5A A side view of a spine member wrapped around a flexible substrate as illustrated in FIG.

[0016] Fig. 6A is a top view of an additional embodiment of a flexible substrate having multiple electrodes according to the disclosed technology;

[0017] Figure 6B is wound on the Fig. 6A A side view of a ridge member in a flexible substrate illustrated in FIG.

[0018] FIG. 7A to FIG. 7B is a detailed view of a spine member wound in an insulating sleeve according to the disclosed technology; and

[0019] Figure 8 is a flow chart illustrating a method of manufacturing a medical probe according to the disclosed technology. DETAILED DESCRIPTION

[0020] The disclosed technology includes an electrode disposed on a flexible substrate that can replace a traditional ring electrode used in a lasso catheter. The disclosed technology can help ensure that contact between at least one electrode disposed on a medical probe and a target tissue is maintained during mapping of electroanatomical signals at a pulmonary vein. In addition, the disclosed technology can help ensure that at least one electrode is not in contact with the tissue, but is electrically connected to the surrounding blood to obtain a reference signal, which can then be used to eliminate noise that can be detected during the mapping procedure. Therefore, the accuracy of the mapping procedure can be improved, and the overall time required to complete a pulmonary vein isolation procedure can be reduced. In addition, the disclosed technology can help simplify the process of manufacturing a lasso catheter, thereby reducing the overall cost of the lasso catheter.

[0021] The following detailed description should be read in conjunction with the accompanying drawings, in which the same elements are labeled the same in different drawings. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. This description will clearly enable those skilled in the art to prepare and use the invention, and describes several embodiments, adaptations, variations, alternative forms and uses of the invention, including the best modes currently believed to be implemented in the invention.

[0022] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a value range of ±20% of the listed value, for example, "about 90%" may refer to a value range of 71% to 110%.

[0023] As used herein, the terms "patient," "receptor," "user," and "subject" refer to any human or animal subject, and are not intended to limit the systems or methods to human use, but the use of the subject invention in human patients represents a preferred embodiment. In addition, the vascular system of the "patient," "receptor," "user," and "subject" can be the vascular system of a human or any animal. It should be understood that the animal can be of any suitable type, including but not limited to mammals, veterinary animals, livestock animals, or pet animals, etc. For example, the animal can be an experimental animal (e.g., rats, dogs, pigs, monkeys, etc.) specifically selected to have certain characteristics similar to humans. It should be understood that the subject can be, for example, any suitable human patient. Similarly, the term "proximal" refers to a position closer to an operator or physician, while "distal" refers to a position farther away from an operator or physician.

[0024] As discussed herein, a "physician" or "operator" may include a physician, surgeon, technician, scientist, or any other individual or delivery instrumentation associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.

[0025] As discussed herein, when referring to the devices and corresponding systems of the present disclosure, the term "ablation" refers to components and structural features configured to reduce or prevent the generation of unstable cardiac signals in cells by utilizing non-thermal energy (such as irreversible electroporation (IRE)), which are interchangeably referred to as pulsed electric fields (PEF) and pulsed field ablation (PFA) in the present disclosure. "Ablation" as used throughout the present disclosure, when referring to the devices and corresponding systems of the present disclosure, refers to non-thermal ablation of cardiac tissue for certain conditions, including but not limited to arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation as understood by those skilled in the relevant art.

[0026] As discussed herein, the terms "bipolar" and "monopolar" when used to refer to ablation regimens describe ablation regimens that differ in terms of current paths and electric field distribution. "Bipolar" refers to an ablation regimen that utilizes a current path between two electrodes as described below, both electrodes being positioned at a treatment site; the current density and electric flux density at each of the two electrodes are generally approximately equal. "Monopolar" refers to an ablation regimen that utilizes a current path between two electrodes as described below, wherein one electrode including a high current density and a high electric flux density is positioned at the treatment site, and a second electrode including a relatively lower current density and a lower electric flux density is positioned away from the treatment site.

[0027] The disclosed technology can be configured to deliver monophasic or biphasic pulses to ablate tissue. For example, the electrodes described herein that are configured to deliver ablative 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 corresponding electrical signals. "Biphasic pulse" refers to an electrical signal that includes a positive voltage phase pulse (referred to herein as a "positive phase") and a negative voltage phase pulse (referred to herein as a "negative phase"). "Monophasic pulse" refers to an electrical signal that includes only a positive phase or a negative phase.

[0028] Ablation of cardiac tissue using the application of thermal techniques such as radiofrequency (RF) energy and cryoablation to correct a malfunctioning heart is a well-known procedure. Typically, in order to successfully ablate using thermal techniques, cardiac electrode potentials need to be measured at various locations in the myocardium. In addition, temperature measurements during ablation provide data that can be used to achieve ablation efficacy. Typically, for ablation procedures using thermal ablation, electrode potentials and temperatures are measured before, during, and after the actual ablation.

[0029] The example systems, methods, and devices of the present invention may be particularly suitable for IRE ablation of cardiac tissue to treat arrhythmias. Ablation energy is typically provided to cardiac tissue by electrodes that can deliver ablation energy along the tissue to be ablated. Fluoroscopy, magnetic-based position sensing, and / or active current localization techniques may be used to visualize ablation procedures involving such example catheters.

[0030] IRE as discussed in the present disclosure is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. To ablate using IRE / PEF, biphasic voltage pulses are applied to destroy the cellular structure of the myocardium. The biphasic pulses are non-sinusoidal and can be tuned to target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, heating all cells indiscriminately in the treatment area. Therefore, IRE has the ability to avoid adjacent heat-sensitive structures or tissues, which will have benefits in reducing possible complications known to be affected by ablation or separation modalities. In addition or alternatively, monophasic pulses can be used.

[0031] Electroporation can be induced by applying a pulsed electric field across biological cells to cause holes to be reversibly (temporarily) or irreversibly (permanently) produced in the cell membrane. When a pulsed electric field is applied, the cell has a transmembrane electrostatic potential that is elevated above the static potential. When the transmembrane electrostatic potential remains below the threshold potential, electroporation is reversible, which means that the hole can be closed when the applied pulsed electric field is removed, and the cell can self-repair and survive. If the transmembrane electrostatic potential is elevated above the threshold potential, electroporation is irreversible and the cell becomes permanently permeable. Therefore, the cell dies due to loss of homeostasis, usually by programmed cell death or apoptosis, which is believed to leave less scar tissue than other ablation methods. Typically, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500V / cm, while for bones, the threshold potential is 3000V / cm. These differences in threshold potentials allow IRE to selectively target tissues based on threshold potentials.

[0032] refer to Figure 1 , which shows an example catheter-based electrophysiological mapping and ablation system 10. The system 10 includes one or more catheters that are inserted into a chamber or vascular structure of the heart 12 by a physician 24 through the vascular system of a patient 23 via the skin. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Then, multiple catheters can be inserted into the delivery sheath catheter to reach the desired location. The one or more catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An example catheter 14 configured for sensing IEGM is illustrated herein. For ablation, the physician 24 brings an end effector 28 including an ablation electrode to a target site for ablation. If the end effector 28 is alternatively or additionally configured for mapping electrophysiological signals (e.g., IEGM signals), the physician 24 similarly contacts the end effector 28 with the heart wall to sense the target site in the heart 12.

[0033] The catheter 14 is an exemplary catheter that includes an end effector 28 that includes one and preferably a plurality of electrodes 26 that are optionally distributed on the expandable assembly and the distal end of the end effector 28 and are configured to detect electrophysiological signals and / or deliver ablation energy to tissue. The catheter 14 may further include a magnetically 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 also include one or more impedance-based electrodes that are disposed in or near the end effector 28 for tracking the position and orientation of the end effector 28.

[0034] The magnetic-based position sensor can operate 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 end effector 28 of the catheter 14 can be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor 29. The magnetic-based position sensor can be a single-axis sensor, a dual-axis sensor, or a three-axis sensor, depending on the specific configuration. The details of the magnetic-based position sensing technology are described in U.S. Patents 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, each of which is incorporated herein by reference as if fully set forth herein.

[0035] The system 10 includes one or more electrode patches 38 positioned in contact with the skin of the patient 23 to establish a position reference for the positioning pad 25 and impedance-based tracking of the electrodes. For impedance-based tracking, current is directed toward the impedance-based electrodes and sensed at the electrode skin patches 38 so that the position of each electrode can be triangulated via the electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference as if fully set forth herein.

[0036] Recorder 11 displays electrograms 21 captured using body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured using electrodes of catheter 14. Recorder 11 may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.

[0037] The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes disposed on an end effector and configured to deliver ablation energy to tissue. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that may be used to achieve irreversible electroporation (IRE)), or a combination thereof.

[0038] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiology equipment, a power source, and a workstation 55 for controlling the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, multiple catheters, positioning pads 25, surface ECG electrodes 18, electrode patches 38, ablation energy generators 50, and recorders 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities for enabling real-time calculation of the position of the catheters and for performing ECG calculations.

[0039] Workstation 55 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 55 can provide multiple functions, optionally including: (1) three-dimensional (3D) modeling of endocardial anatomy and rendering of the model or anatomical map 20 for display on display device 27; (2) displaying on display device 27 an activation sequence (or other data) compiled from recorded electrograms 21 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of multiple catheters within the heart chamber; and (4) displaying on display device 27 sites of interest, such as where ablation energy has been applied. A commercial product embodying elements of system 10 may be CARTO TM 3 System was purchased from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0040] Now turn to FIG. 2A to FIG. 2D , various views of an end effector 28 are shown and described. The end effector 28 may form a distal end of a medical probe. Figure 2A This is a top perspective view. Figure 2B This is a bottom perspective view. Figure 2C is a side view, and Figure 2D is a top view of a medical probe. As shown, the end effector 28 can be attached to the distal end of the insertion tube 102 extending along the longitudinal axis LA. The end effector 28 can be configured to bend radially outward from the longitudinal axis LA in a generally circular configuration in a direction generally perpendicular to the longitudinal axis LA. The end effector 28 can be attached to the insertion tube 102 at the proximal end 112, extend a predetermined distance generally along the longitudinal axis LA, and then bend generally perpendicular to the longitudinal axis LA to form a circular configuration to the distal end 114 together with the remainder of the end effector 28.

[0041] The end effector 28 may 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 may be made of an elastic material and configured to form a generally circular shape of the end effector 28. For example, the shape memory material may be nitinol or other biocompatible material, and when deployed from the insertion sheath, the shape memory material may be biased to form a generally circular shape. The electrode assembly 150 may include a flexible substrate 120, which includes a plurality of electrical leads 122 extending along at least a portion of the flexible substrate 120. The electrode assembly 150 may also include a plurality of electrodes 26 disposed on the flexible substrate 120, and each electrode 26 may be electrically connected to at least one of the plurality of electrical leads 122 and configured to detect electroanatomical signals. The flexible substrate 120 may be wrapped around the spine member 104 of the end effector 28 and positioned so that at least some of the plurality of electrodes 26 are away from the longitudinal axis LA. In this manner, end effector 28 may include at least some electrodes 26 that are configured to contact tissue when inserted into a pulmonary vein.

[0042] Although the disclosed techniques throughout this disclosure are described as being primarily used to perform mapping of electroanatomical signals, it should be understood that, alternatively or in addition, the disclosed techniques 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, electroanatomical signals for delivering ablative energy to tissue, or both. If the electrodes 26 are configured to deliver ablative energy to tissue, the electrodes 26 may be configured for RF ablation or IRE ablation. In addition, the electrodes 26 may be configured to deliver a unipolar signal having a monophasic pulse or a bipolar signal having a biphasic pulse.

[0043] Figure 3 The spine member 104 is illustrated as being wound in 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 wound around the spine member 104, the plurality of electrodes 26 may be arranged along the flexible substrate so that each electrode 26 of the plurality of electrodes 26 is spaced a distance D from an adjacent electrode 26 of the plurality of electrodes 26. 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 other examples, the distance D may be about 9 mm.

[0044] The plurality of electrodes 26 may be arranged on the flexible substrate 120 such that the plurality of 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.

[0045] In addition, if the Figure 5A and Fig. 6A Described in more detail, it should be understood that the flexible substrate 120 may include a plurality of electrodes 26 disposed on the flexible substrate 120 in a group, the electrodes being distributed along the flexible substrate 120 such that when the flexible substrate 120 is wound around the spine member 104 of the medical probe, at least one electrode 26 faces the tissue and at least one electrode 26 faces the blood. In addition, once the flexible substrate 120 has been spirally wound on the spine member 104, the insulating sleeve 130 may be disposed on the electrode assembly 150 of the flexible substrate 120.

[0046] Figure 4 Example along Figure 3 XX. As described and explained above, the flexible substrate 120 wrapped around the spine member 104 may include a plurality of electrodes 26 arranged so that a plurality of electrodes 26 in the plurality of electrodes 26 may be substantially aligned around the circumference of the spine member 104. In addition, the electrodes 26 may be spaced apart from each other at an angle θ degrees around the circumference of the spine member 104. In some examples, θ may be approximately 120 degrees. In another example, θ may be approximately 180 degrees, approximately 90 degrees, approximately 60 degrees, approximately 30 degrees, or other angles depending on the number of electrodes and the specific configuration. In some examples, the electrodes 26 may be equally spaced along the circumference of the spine member 106, or the electrodes may be unequally spaced (e.g., a greater number of electrodes 26 may be configured to be substantially away from the longitudinal axis or vice versa). As should be understood, when the medical device is inserted into a lumen of the body, at least one electrode 26 in the plurality of electrodes 26 may be configured to face the tissue, and another electrode 26 may be configured to face the blood.

[0047] Now go to FIG. 5A to FIG. 5B , Figure 5A A top view of an electrode assembly 150 is illustrated. 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 also 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. Figure 5BA side view of a flexible substrate 120 helically wound around a spine member 104 is illustrated. The flexible substrate 120 can be wound around the spine member 104 such that at least some of the plurality of electrodes 26 are away from the longitudinal axis LA of the spine member 104. FIG. 5A to FIG. 5B In the embodiment of the present invention, the plurality of electrodes 26 may be arranged 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 the electrode 26 is positioned away from the longitudinal axis LA. The electrodes 26 in the plurality of electrodes 26 may be spaced approximately 120 degrees apart around the circumference of the spine member 104, such as Figure 4 In addition, as previously described, the electrodes 26 may be spaced apart a distance D along the longitudinal axis LA of the spine member 104. As will be appreciated, D may be a range of distances corresponding to the number of electrodes 26 disposed along the flexible substrate 120 and a particular configuration.

[0048] FIG. 6A to FIG. 6B A flexible substrate 120 is illustrated that may include a plurality of electrodes 26 arranged on the flexible substrate 120 such that at least four electrodes 26 are aligned around the circumference of the spine member 104 at each location where the electrode 26 is positioned away from the longitudinal axis LA of the spine member 104. For example, when the electrode assembly 150 is wrapped around the spine member 104, the electrodes 26 may be configured to be spaced approximately 90 degrees from each other. It should be understood that the plurality of electrodes 26 may include any number of electrodes 26, and the angle θ may be a range of degrees, assuming that the plurality of electrodes 26 are spaced apart from each other around the circumference of the spine member 104. For example, two electrodes 26 of the plurality of electrodes 26 will be spaced apart approximately 180 degrees, five electrodes will be spaced apart approximately 72 degrees, etc., as will be understood by one of ordinary skill in the relevant art.

[0049] Now go to FIG. 7A to FIG. 7B , Fig. 7A An insulating sleeve 130 is illustrated that may be disposed on an electrode assembly 150 of a spine member 104, the electrode assembly 150 including a plurality of electrodes 26. The insulating sleeve 130 may include a plurality of apertures 132 extending through the insulating sleeve 130 such that each aperture 132 of the insulating sleeve 130 is aligned with each electrode 26 of the plurality of electrodes 26. In other words, the apertures 132 may be configured to at least partially expose the electrodes 26. Fig. 7A In the example shown, the aperture 132 of the insulating sleeve 130 may partially expose a portion of the spine member 104 .

[0050] Aperture 132 may be formed in insulating sleeve 130 before installing insulating sleeve 130 on electrode assembly 150 and spine member 104. Alternatively, aperture 132 may be cut in insulating sleeve 130 to expose electrode 26 after installing insulating sleeve 130 on electrode assembly 150 and spine member 104.

[0051] Figure 7B The insulating sleeve 130 that may be disposed on the electrode assembly 150 and the spine member 104 is illustrated. As previously described, the insulating sleeve 130 may include a plurality of apertures 132 extending through the insulating sleeve 130 to at least partially expose the electrode 26. However, in this example, the apertures 132 may include a plurality of apertures 132 extending through the insulating sleeve 130 at each electrode 26, rather than as Fig. 7A The insulating sleeve 130 may include a plurality of large orifices 132 as shown. In this manner, in addition to providing electrical insulation to unexposed areas of the electrode assembly 150, the insulating sleeve 130 may also be configured to provide mechanical protection to the electrode 26. The size and spacing of the plurality of orifices 132 may be set to ensure that the electrode 26 is able to conduct sufficient electricity to or from the tissue and / or blood. In some examples, although not shown, the insulating sleeve 130 may include a plurality of irrigation holes extending through the insulating sleeve 130, each of which is configured to allow an irrigation fluid to flow through the plurality of irrigation holes.

[0052] Figure 8 A flow chart is illustrated disclosing a method 800 of manufacturing a medical probe. The method 800 may include forming 802 a spine member 120 into a generally circular shape and spirally winding 804 the spine member with an electrode assembly 150, the electrode assembly 150 including a flexible substrate 120, a plurality of electrical leads 122 extending along at least a portion of the flexible substrate 104, and a plurality of electrodes 26 disposed on the flexible substrate. The method 800 may include disposing 806 an insulating sleeve 130 on the electrode assembly 150 and forming 808 a plurality of apertures 132 through the insulating sleeve 130, the plurality of apertures being configured to align with the plurality of electrodes 26.

[0053] In some examples, the plurality of electrical leads 122 of the method 800 may be electrically connected to at least one electrical lead 122 of the plurality of electrical leads 122. In addition, the plurality of electrodes 26 may be positioned on the flexible substrate 120 such that when the electrode assembly 150 is helically wound around the spine member 104, at least some of the plurality of electrodes 26 may be positioned away from the axis of the generally circular shape of the spine member 104. As described above, the electrode assembly 150 may include any number of electrodes 26. In some examples, the medical probe may also include a position sensor (not shown) configured to generate a current when subjected to an electromagnetic field.

[0054] With respect to the above examples, in certain embodiments, the end effector 28 has a delivery configuration and an expansion configuration. When in the delivery configuration, the end effector 28 is generally straight, that is, it can be in a linear configuration to advance through the catheter 14 and be delivered to the heart. Once inside the heart and expanded from the catheter, the end effector 28 can take the shape of a lasso as illustrated herein. Positioning the electrode 26 with both the distance D and the angular displacement angle θ is usually performed when the end effector is in the expansion configuration. When in the linear delivery configuration, the distance D and the angle θ can be different. In addition, as shown in the figure, the flexible substrate 120 can space the distance between the electrodes 26 when linear to allow the distance D and the angle θ to be met once it is wrapped around the ridge 104 and expanded.

[0055] The disclosed technology described herein can be further understood according to the following terms:

[0056] Item 1: An electrode assembly for a medical device, the 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 of the plurality of electrodes being electrically connected to at least one of the plurality of electrical leads, the plurality of electrodes being positioned on the flexible substrate such that when the electrode assembly is wound around an end effector member wound around a longitudinal axis to define a lasso catheter, at least some of the plurality of electrodes are positioned on a side of the lasso catheter away from the longitudinal axis extending through the lasso catheter.

[0057] Clause 2: The electrode assembly of clause 1, each electrode of the plurality of electrodes being configured to detect an electroanatomical signal.

[0058] Clause 3: The electrode assembly of clauses 1 and 2, wherein the plurality of electrodes are arranged in a spiral 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.

[0059] Clause 4: The electrode assembly of clause 1, the plurality of electrodes arranged on the flexible substrate such that at least three electrodes are substantially aligned around the circumference of the lasso catheter at each location where an electrode is positioned away from the longitudinal axis.

[0060] Clause 5: The electrode assembly of clause 4, the at least three electrodes being spaced approximately 120 degrees apart from one another around the circumference of the lasso catheter.

[0061] Clause 6: The electrode assembly of clause 5, wherein when the lasso catheter is inserted into a lumen of a body, at least one of the at least three electrodes is configured to face tissue and at least another of the at least three electrodes is configured to face blood.

[0062] Item 7: A medical probe, comprising: an insertion tube extending along a longitudinal axis; an end actuator disposed at a distal end of the insertion tube, the end actuator being configured to bend radially outward from the longitudinal axis approximately perpendicular to the longitudinal axis, the end actuator 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 of the plurality of electrodes being electrically connected to at least one of the plurality of electrical leads, the plurality of electrodes being wrapped around the spine member, and at least some of the plurality of electrodes being positioned away from the longitudinal axis.

[0063] Clause 8: The medical probe of clause 7, each electrode of the plurality of electrodes being configured to detect an electroanatomical signal.

[0064] Clause 9: The medical probe of clause 7, the plurality of electrodes being arranged on the flexible substrate such that at least three electrodes are aligned around the circumference of the spine member at each location where an electrode is positioned away from the longitudinal axis.

[0065] Clause 10: The medical probe of clause 9, the at least three electrodes being spaced approximately 120 degrees apart from one another around the circumference of the spine member.

[0066] Clause 11: The medical probe according to clauses 9 and 10, when the medical probe is inserted into a lumen of the body, at least one of the at least three electrodes is configured to face tissue and at least another of the at least three electrodes is configured to face blood.

[0067] Clause 12: The medical probe of clauses 7 to 11, wherein the plurality of electrodes are arranged along the flexible substrate such that when the electrode assembly is spirally wound around the spine member, each of the plurality of electrodes is spaced approximately 9 millimeters from an adjacent electrode of the plurality of electrodes.

[0068] Clause 13: The medical probe according to clauses 7 to 12, further comprising an insulating sleeve disposed on the electrode assembly.

[0069] Clause 14: The medical probe of Clause 13, the insulating sleeve comprising a plurality of apertures extending therethrough, the plurality of apertures configured to align with the plurality of electrodes.

[0070] Clause 15: The medical probe of clauses 13-14, the plurality of apertures comprising a plurality of apertures extending through the insulating sleeve at each electrode of the plurality of electrodes.

[0071] Clause 16: The medical probe of clauses 13 to 15, the insulating sleeve comprising a plurality of irrigation holes extending through the insulating sleeve, the plurality of irrigation holes being configured to allow irrigation fluid to flow through the plurality of irrigation holes.

[0072] Clause 17: The medical probe of clauses 7 to 16, further comprising a position sensor configured to generate an electric current when subjected to an electromagnetic field.

[0073] Item 18: A method comprising: forming a spine member into a generally circular shape; and spirally winding the spine member using 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; and a plurality of electrodes disposed on the flexible substrate, each of the plurality of electrodes being electrically connected to at least one of the plurality of electrical leads, the plurality of electrodes being positioned on the flexible substrate such that when the electrode assembly is spirally wound around the spine member, at least some of the plurality of electrodes are positioned away from an axis of the generally circular shape of the spine member.

[0074] Clause 19: The method of clause 18, further comprising disposing an insulating sleeve on the electrode assembly.

[0075] Clause 20: The method of clause 19, further comprising forming a plurality of apertures through the insulating sleeve, the plurality of apertures configured to align with the plurality of electrodes.

[0076] The above embodiments are cited by way of example, and the present invention is not limited by what is specifically shown and described above. On the contrary, the scope of the present invention includes combinations and sub-combinations of the various features described and shown above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description and which are not disclosed in the prior art.

Claims

1. An electrode assembly for a medical device, the 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 of the plurality of electrodes being electrically connected to at least one 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 around a longitudinal axis to define a lasso catheter, at least some of the plurality of electrodes are positioned on a side of the lasso catheter away from the longitudinal axis extending through the lasso catheter.

2. The electrode assembly of claim 1, each of the plurality of electrodes being configured to detect an electroanatomical signal. 3 . The electrode assembly of claim 1 , wherein the plurality of electrodes are spirally arranged along the flexible substrate such that each electrode of the plurality of electrodes is spaced approximately 9 mm from an adjacent electrode of the plurality of electrodes.

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

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

6. The electrode assembly according to claim 5, when the lasso catheter is inserted into a lumen of a body, at least one 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.

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 being configured to bend radially outward from the longitudinal axis substantially 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: Flexible substrates; a plurality of electrical leads extending along at least a portion of the flexible substrate; and A plurality of electrodes are disposed on the flexible substrate, each of the plurality of electrodes being electrically connected to at least one of the plurality of electrical leads, the plurality of electrodes being wrapped around the spine member, and at least some of the plurality of electrodes being positioned away from the longitudinal axis. 8 . The medical probe of claim 7 , each electrode of the plurality of electrodes being configured to detect an electroanatomical signal.

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

10. The medical probe of claim 9, the at least three electrodes being spaced approximately 120 degrees apart from one another around the circumference of the spine member. 11 . The medical probe according to claim 10 , when the medical probe is inserted into a lumen of a body, at least one 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.

12. The medical probe of claim 7, the plurality of electrodes being arranged 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 when the electrode assembly is spirally wound around the spine member.

13. The medical probe according to claim 12, further comprising an insulating sleeve disposed on the electrode assembly.

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

15. The medical probe of claim 14, the plurality of apertures comprising a plurality of apertures extending through the insulating sleeve at each electrode of the plurality of electrodes. 16 . The medical probe of claim 13 , the insulating sleeve comprising 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 claim 7, further comprising a position sensor configured to generate an electric current when subjected to an electromagnetic field.

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

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

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

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