Magnetic sensor sensitivity enhancement

Abstract

To provide a magnetic location sensor.SOLUTION: The disclosed technology includes a magnetic location sensor which may comprise first and second spiral coils that can be disposed on a planar substrate. The first and second spiral coils may be disposed about respective first and second center axes. Each of the first and second coils can be configured to generate a voltage when subjected to a magnetic field. The magnetic location sensor may also comprise a high-magnetic-permeability planar member that can be disposed near one of the first and second spiral coils. The high-magnetic-permeability planar member can be disposed on the magnetic location sensor such that if the planar substrate is wrapped around a cylindrical substrate, the high-magnetic-permeability planar member may be disposed on an intersection of the first and second center axes.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority under 35 U.S.C. § 119(e) to and the benefit of U.S. Provisional Application No. 63 / 519,970, filed August 16, 2023 (Attorney Docket No. BIO6837USPSP1-253757.000385), the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THEINVENTION The present invention relates generally to magnetic sensors, and more particularly to magnetically permeable materials disposed in proximity to a magnetic sensor that can help increase the magnetic sensitivity of the magnetic sensor. [Background technology]

[0003] A magnetic sensor is a sensor capable of detecting the magnitude and variation of a radiated magnetic field and outputting an electrical signal indicative of the detected magnitude and variation of the radiated magnetic field. Magnetic sensors include, but are not limited to, coiled magnetic sensors, reed switches, Hall effect elements, magnetoresistance elements, superconducting quantum interference devices, and the like. Medical positioning systems utilize magnetic sensors to track medical devices within a patient's body. Conventionally, to locate a medical device within a patient's body, a medical positioning system includes a magnetic field generator configured to emit one or more magnetic fields to induce an electrical signal from the magnetic sensor. The accuracy and reliability of the magnetic sensor are directly proportional to the strength of the induced voltage emitted as an electrical signal by the magnetic sensor. As a result, a larger induced voltage from the magnetic sensor provides greater resolution and accuracy via a stronger electrical signal to the medical positioning system.

[0004] One way to increase the strength of the induced voltage emitted by a magnetic sensor is to increase the number of windings or loops on the magnetic sensor to increase the sensitivity of the sensor. However, the problem with this method is that the additional windings or loops generally increase the size of the magnetic sensor. This makes some magnetic sensors oversized and inapplicable to areas of medical devices where position sensing may be desired. For example, catheter end effectors may not be able to support current magnetic sensors due to the large dimensional footprint of the magnetic sensor resulting from increasing the number of windings or loops.

[0005] As can be appreciated, magnetic sensors with larger dimensional footprints or lower induced voltages may be incompatible with medical devices and may reduce the accuracy of position data relayed to medical positioning systems. The techniques disclosed herein address the above-mentioned challenges. Summary of the Invention [Means for solving the problem]

[0006] According to one example of the present technology, a magnetic position sensor is provided that may include a first spiral coil and a second spiral coil that may be disposed on a planar substrate. The first spiral coil and the second spiral coil may be disposed around respective first and second central axes, and each of the first and second coils may be configured to generate a voltage when exposed to a magnetic field. The magnetic position sensor may also include a high permeability planar member that may be disposed near one of the first spiral coil and the second spiral coil. The high permeability planar member may be disposed on the magnetic position sensor such that when the planar substrate is wrapped around a cylindrical substrate, the high permeability planar member may be disposed on the intersection of the first and second central axes.

[0007] According to one example of the present technology, an electrode assembly is provided that may include a planar substrate, an electrode, an electromagnetic coil, and a member. The planar substrate may extend along a longitudinal axis. The electrode may be disposed on the planar substrate and may be configured to detect electrophysiological signals. The electromagnetic coil may be disposed on the planar substrate and may be configured to generate a voltage when exposed to a magnetic field. The member may include a high magnetic permeability material that may be disposed near the electromagnetic coil.

[0008] According to one example of the present technology, an end effector is provided that may include a plurality of electrodes, a coil, and a member. The plurality of electrodes may be disposed along the end effector and may be configured to detect electrophysiological signals. The coil may be disposed along the end effector and may be configured to generate a voltage when exposed to a magnetic field. The member may be disposed near the coil and may include a high magnetic permeability material.

[0009] The end effector may have a generally planar shape, and the plurality of electrodes may be arranged along the generally planar shape in an arrangement of one or more rows. The coil may be arranged along a periphery of the generally planar shape of the end effector.

[0010] According to one example of the present technology, an end effector is provided that may include a body, a plurality of first electrode assemblies, and a plurality of second electrode assemblies. The body may have a generally planar shape. The plurality of first electrode assemblies may be disposed along the body and may be configured to detect electrophysiological signals. The plurality of second electrode assemblies may be disposed along the body of the end effector.

[0011] Each electrode assembly of the plurality of second electrode assemblies may include an electrode, a coil, and a member. The electrode may be configured to detect an electrophysiological signal. The coil may be disposed on the body of the end effector and may be configured to generate a voltage when exposed to a magnetic field. The coil may include a helical shape that may have a width approximately equal to a width of the electrode. The member may include a high magnetic permeability material.

[0012] In accordance with one example of the present technology, an end effector is provided that may include a plurality of flexible spines and a plurality of electrode assemblies. The plurality of flexible spines may be configured to transition the end effector between an extended configuration and a collapsed configuration. The plurality of electrode assemblies may be disposed along the plurality of flexible spines, and each of the plurality of electrode assemblies may include a substrate, an electrode, a coil, and a member.

[0013] The substrate may extend at least partially along one of the plurality of flexible spines. The electrode may be disposed on a first side of the substrate and may be configured to detect an electrophysiological signal. The coil may be disposed on a second side of the substrate and may be configured to generate a voltage when exposed to a magnetic field. The member may include a high magnetic permeability material.

[0014] Additional features, functions, and applications of the techniques of the present disclosure are discussed in greater detail herein. [Brief description of the drawings]

[0015] [Figure 1] 1 is a schematic diagram of a medical system including a catheter and a handle, according to an example of the technology of the present disclosure. [Diagram 2] 1 is a schematic diagram of a catheter and handle according to an example of the disclosed technology; [Diagram 3] FIG. 13 is a detailed view of an end effector of a catheter, according to an example of the disclosed technology. [Figure 4A] FIG. 2 is a detailed diagram of a magnetic sensor according to an example of the disclosed technology. [Figure 4B] FIG. 1 is a detailed diagram of a magnetic sensor having a high magnetic permeability material attached to the magnetic sensor in a first configuration, according to an example of the disclosed technology. [Figure 4C] FIG. 13 is an alternative detailed view of a magnetic sensor having a high magnetic permeability material attached to the magnetic sensor in a second configuration, according to an example of the disclosed technology. [Figure 4D] FIG. 1 is a perspective view of a high magnetic permeability material disposed between two magnetic sensors according to an example of the disclosed technology. [Figure 4E] FIG. 1 is a perspective view of a magnetic sensor and a high magnetic permeability material attached to the magnetic sensor, according to an example of the disclosed technology. [Figure 5A] 1 is a photograph of a magnetic sensor assembly having a high magnetic permeability material disposed between two magnetic sensors according to an example of the disclosed technology. [Figure 5B] FIG. 5B is an x-ray view of the magnetic sensor assembly of FIG. 5A in accordance with an example of the technology of this disclosure. [Figure 5C] 1 is a photograph of a magnetic sensor assembly having a high magnetic permeability material disposed between two magnetic sensors in accordance with another embodiment of the disclosed technique. [Figure 5D] FIG. 5D is an X-ray view of the magnetic sensor assembly of FIG. 5C, in accordance with an example of the technology of the present disclosure. [Figure 6] 1 is a multivariate graph illustrating the relationship between concentrations of high permeability materials with various cores, according to an example of the disclosed technology; [Figure 7] 1 is a multivariate graph illustrating the relationship between magnetic sensitivity and concentration of high magnetic permeability material, according to an example of the disclosed technology. [Figure 8] 13 is a table illustrating the magnetic sensitivity of various concentrations of high permeability material for three sample electrode assemblies at given frequencies in accordance with an example of the disclosed technology. [Figure 9A] FIG. 1 is a perspective view of an exemplary end effector assembly including an electrode and a magnetic sensor assembly according to an example of the disclosed technology. [Figure 9B] FIG. 9B is a perspective view of the magnetic sensor assembly of FIG. 9A in accordance with an example of the technology of the present disclosure. [Figure 9C]FIG. 9C is a perspective view of the magnetic sensor and high magnetic permeability material of FIGS. 9A and 9B in accordance with an example of the technology of this disclosure. [Figure 9D] FIG. 9C is a perspective view of the magnetic sensor and high magnetic permeability material of FIGS. 9A and 9B in accordance with an example of the technology of this disclosure. [Figure 10] FIG. 13 is a perspective view of another exemplary end effector assembly having a high magnetic permeability material in an alternative configuration in accordance with an example of the disclosed technology; [Figure 11A] FIG. 13 is a top view of an electrode assembly having a high magnetic permeability material, according to an example of the disclosed technology. [Figure 11B] FIG. 11B is a cross-sectional view of an electrode assembly having a high magnetic permeability material as shown in FIG. 11A according to an example of the technology of the present disclosure. [Figure 11C] FIG. 13 is a bottom view of an electrode assembly having a high magnetic permeability material according to an example of the disclosed technology. [Figure 12A] FIG. 1 is a cross-sectional view of an electrode assembly having a high magnetic permeability material according to an example of the disclosed technology. [Figure 12B] FIG. 1 is a cross-sectional view of an electrode assembly having a high magnetic permeability material according to an example of the disclosed technology. [Figure 12C] FIG. 13 is another cross-sectional view of an electrode assembly having a high magnetic permeability material in accordance with an example of the disclosed technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] 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 examples and are not intended to limit the scope of the invention. The detailed description illustrates, by way of example and not by way of limitation, the principles of the invention. The description clearly enables one skilled in the art to make and use the invention and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is currently contemplated to be the best mode for carrying out the invention.

[0017] As used herein, the term "about" or "approximately" with respect to any numerical value or range indicates suitable dimensional tolerances that allow 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, e.g., "about 90%" may refer to a range of values ​​of 71% to 110%. Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and while use of the invention in a human patient represents a preferred embodiment, it is not intended to limit the system or method to human use. 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.

[0018] As discussed herein, the vascular system of a "patient," "host," "user," and "subject" may be that of a human or any animal. It should be understood that the animal may be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals. As an example, the animal may be a laboratory animal (e.g., rats, dogs, pigs, monkeys, etc.) that is specifically selected to have certain characteristics similar to humans. It should be understood that the subject may be, for example, any applicable human patient.

[0019] As discussed herein, a "physician" may include a physician, surgeon, technician, scientist, operator, or any other individual or delivery instrumentation involved in the delivery of a multi-electrode catheter for the treatment of drug refractory atrial fibrillation to a subject.

[0020] It should be noted that the electrodes described and illustrated herein are not limited to mapping (i.e., sensing or recording signals) and can be used to deliver energy such as RF (alternating current cycles) or IRE (DC pulses) in bipolar or monopolar modes alone or in combination with mapping or sensing functions. For IRE applications, the electrodes can be configured to deliver at least 900V per electrode with a current of at least 20 amps for a number of pulses sufficient to induce cell apoptosis.

[0021] 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 configured to reduce or prevent the generation of irregular cardiac signals within cells by utilizing non-thermal energy, such as reversible or irreversible electroporation (IRE), interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA), or thermal energy, such as radiofrequency (RF) ablation or cryoablation. In the context of the devices and corresponding systems of the present disclosure, ablation or ablation is used throughout the present disclosure in reference to thermal or non-thermal ablation of cardiac tissue for specific conditions, including, but not limited to, arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablate" or "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation, as will be understood by those skilled in the art.

[0022] FIG. 1 illustrates an exemplary system 10 that may include a catheter 14. The catheter 14 may be configured to navigate to the heart 12 of a patient 23 and map and / or ablate myocardial tissue. The system 10 may be configured for multiple catheters to be percutaneously inserted by a physician 24 through the vascular system of the patient 23 and into a cavity or vasculature of the heart 12. Typically, the catheter 14 is inserted into the left or right atrium near a desired location of the heart 12. The multiple catheters 14 may then be inserted into the catheter 14 to reach the desired location. The multiple catheters may include catheters dedicated to sensing Intracardiac Electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An exemplary catheter 14 configured to sense IEGMs is illustrated herein. The physician 24 contacts the distal tip of a mapping catheter with the heart wall to sense a target site on the heart 12. The mapping catheter end effector may include a basket catheter, a planar catheter, a focal catheter, a balloon catheter, etc. For ablation, the physician 24 similarly delivers the distal end of an ablation catheter to the target site for ablation. Similarly, the ablation catheter end effector may include a basket catheter, a planar catheter, a focal catheter, a balloon catheter, etc.

[0023] The catheter (14) is an exemplary catheter that includes one, and preferably multiple, electrodes (127) optionally distributed across the distal end (28) of the catheter (14) for tracking the position and orientation of the catheter (14). Optionally and preferably, the electrodes (127) may be a magnetic-based position sensor including three magnetic coils for sensing three-dimensional (3D) position and orientation. The catheter (14) may further include a position sensor that may be configured for impedance-based position tracking. As shown in FIG. 2, the catheter (14) may include a handle (100) at its proximal end.

[0024] The magnetic-based position sensor (e.g., electrode 127) may be operated 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 distal end (28) of the catheter (14) may be tracked based on the magnetic field generated at the location pad (25) and sensed by the magnetic-based position sensor (e.g., electrode 127). 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 herein by reference.

[0025] The system 10 may include one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a location reference for the location pads 25 as well as impedance-based tracking of the electrodes (not shown). For impedance-based tracking, a current is directed to the 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 location 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 herein by reference.

[0026] The recorder 11 displays electrograms 21 captured by the body surface ECG electrodes 18, and intracardiac electrograms (IEGMs) captured by electrodes 138 of the catheter 14. The recorder 11 may include pacing functionality for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.

[0027] The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at a distal tip of a catheter configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radiofrequency (RF) energy, including monopolar or bipolar high voltage direct current (DC) pulses, or Pulsed-Field Ablation (PFA) energy, or combinations thereof, such as may be used to effect irreversible electroporation (IRE).

[0028] 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, a number of 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 further includes processing capabilities for implementing real-time calculation of catheter location and performing ECG calculations.

[0029] The workstation (55) includes a processor unit having a memory, a memory or storage device with appropriate operating software loaded therein, and user interface functionality. The workstation (55) may optionally provide multiple functions including: (1) modeling endocardial anatomical structures in three dimensions (3D) and rendering a model or anatomical map (20) for display on a display device (27), (2) displaying activation sequences (or other data) compiled from recorded electrograms (21) in a representative visual representation 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 heart chambers, and (4) displaying sites of interest, such as locations where ablation energy has been applied, on the display device (27). One commercially available product embodying elements of system (10) is available as the CARTO™ 3 system, commercially available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0030] FIG. 2 is a schematic diagram of a perspective view of a catheter (100) in accordance with the technology of the present disclosure. The catheter (100) may be or may include the same catheter (14) previously described. The catheter (100) may have a handle (110) at a proximal end of the catheter (100) and an end effector (140) disposed on a distal end (28) of the catheter (100). The catheter (100) may be configured for insertion and navigation of a patient's vasculature to position the distal end (28) of the catheter (100) within a cavity of the patient's heart (12). The catheter assembly (100) may include the handle (110), a tubular shaft (120) extending distally from the handle (110), an end effector (140) disposed on the distal end (28) of the tubular shaft (120), and a deflection drive actuator (114) associated with the handle (110). As described in more detail below, the end effector (140) includes various components configured to deliver ablation energy to a target tissue site, provide electrophysiology (EP) mapping functionality, detect external forces applied to the end effector (140), detect the position of the end effector (140), and / or distribute irrigation fluid. The deflection drive actuator (114) is rotatable relative to the casing (112) of the handle (110) and is capable of deflecting the end effector (140) and a distal portion of the tubular shaft (120) away from a central longitudinal axis (LA) extending along the tubular shaft (120). A variety of suitable components that may be coupled with the deflection drive actuator (114) and the tubular shaft (120) to provide such functionality will be apparent to those of skill in the art in view of the teachings herein.

[0031] As previously discussed, at least the distal end (28) of the sheath (106) can include one or more electrodes (127) configured for position sensing (e.g., magnetic or impedance-based position tracking). The distal end of the catheter (100) can be configured to deflect in one or more directions to enable steering of the catheter (100). For example, the catheter (100) can include one or more pull wires (not shown) attached to a deflection drive actuator (114) configured to pull on the one or more pull wires when actuated to deflect the distal end (28), as will be appreciated by one of ordinary skill in the art.

[0032] The handle (100) may further include an irrigation supply tube (111) that may direct saline or other irrigation fluid from an irrigation supply into the handle (110) for delivery to the distal end (28). The handle (100) may also include an electrical connector (not shown) that may be electrically connected to one or more electrodes (127) and may be configured to connect to the PIU (30) via a cable or other suitable electrical connection as shown in FIG.

[0033] FIG. 3 illustrates an exemplary end effector (140) of the catheter (100). However, the end effector (140) illustrated in FIG. 3 is provided for illustrative purposes and should not be construed as limiting. It will be appreciated that various other types of end effectors may be used in place of the end effector (140) illustrated in FIG. 3, such as basket catheters, planar catheters, balloon catheters, round catheters, catheters with multiple spines, etc. As illustrated in FIG. 3, the distal tip (28) of the handle (100) may include a cylindrical body (156) having a dome tip. The cylindrical body (156) and the dome tip may be formed from a conductive material, such as a metal, to form an electrode configured to deliver ablation energy to tissue. A plurality of openings (158) may be formed through the cylindrical body (156) that communicates with a hollow interior of the distal tip (28). The openings (158) may allow irrigation fluid to communicate from the interior of the distal tip (28) through the cylindrical body (156) via the irrigation supply tube (111) and out, as shown in Figures 2 and 3. The cylindrical body (156) and dome tip may also be operable to apply ablative electrical energy to tissue, thereby ablating the tissue. Such ablative electrical energy may be communicated from an ablation energy generator (50). The distal tip (28) may also include one or more thermocouples (not shown), which may be configured to provide temperature sensing functionality, thereby preventing overheating of the distal tip member (142) or adjacent tissue.

[0034] As shown in FIG. 3, the distal tip member (28) of the catheter (100) may also include one or more electrophysiological (EP) mapping microelectrodes (138) attached to the cylindrical body (156). The EP mapping microelectrodes (138) may be configured to pick up electrical potentials from tissue in contact with the EP mapping microelectrodes (138). Thus, the EP mapping microelectrodes (138) may be used to determine the location of abnormal electrical activity in tissue within the cardiovascular anatomical structure (e.g., pulmonary veins, etc.). The signals picked up by the EP mapping microelectrodes (138) may be communicated via a cable to the PIU (30). The PIU (30) may process the EP mapping signals and provide corresponding feedback to the physician (PH) indicating the location of the abnormal electrical activity in accordance with the teachings of the various references cited herein.

[0035] When the cylindrical body (156) is formed of an electrically conductive material to deliver ablative electrical energy for tissue ablation, an electrically insulating material may be interposed between the cylindrical body (156) and the EP mapping microelectrode (138), thereby electrically insulating the EP mapping microelectrode (138) from the cylindrical body (156). The EP mapping microelectrode (138) may be constructed and operative in accordance with the teachings of the various patent references cited herein. Although only one EP mapping microelectrode (138) is shown, the distal tip (28) may include two or more EP mapping microelectrodes (138). Alternatively, the distal tip member (142) may be completely devoid of an EP mapping microelectrode (138).

[0036] FIG. 4A is a detailed view of the position sensor (127) (sometimes referred to herein as a “magnetic position sensor” or “magnetic sensor”). As shown in FIG. 4A, the position sensor (127) can include a flexible substrate (402) having a plurality of openings (404) formed therethrough. The flexible substrate (402) can be formed from a polyimide material, a liquid crystal polymer (LCP) material, and / or any other suitable type of material. The flexible substrate (402) can also include a tail portion (406). The electrode pads (420, 422) can be configured to contact the blood and measure the impedance of the blood, which can be used for impedance sensing or for measuring electrophysiological mapping reference signals in the blood. In some embodiments, the electrode pads (420, 422) can be used to obtain impedance measurements that can be further used to provide position sensing, as disclosed in U.S. Pat. Nos. 7,869,865 and 8,456,182, the disclosures of each of which are incorporated herein by reference in their entirety. As one skilled in the art will appreciate, the electrode pads (420, 422) can behave as a second type of navigation sensor. In certain scenarios, using the electrode pads (420, 422) as a second type of navigation sensor may not be as accurate as the first type of navigation sensor (e.g., an electromagnetic position sensor) and therefore may require a position matrix to be generated before this second type of navigation sensor (e.g., impedance position sensing) can be seen by the operator.

[0037] As a result, the impedance signals from the electrode pads (420, 422) can be used along with signals from a coil-based sensor (e.g., a navigation sensor formed by the first and second coils (410, 412)) to create a position matrix, similar to the teachings provided above. In some embodiments, the electrode pads (420, 422) are used to contact tissue and thereby measure tissue impedance for other purposes. In this example, the position sensor (127) includes only two electrode pads (420, 422), although the position sensor (127) may include only one electrode pad or may include more than two electrode pads.

[0038] 4B, 4C, and 4D show detailed views of the position sensor (127) with high permeability materials (450A, 450B) attached to the position sensor (127) in one or more configurations. As one skilled in the art would understand, high permeability materials can be easily aligned with an applied magnetic field. As used herein, "permeability" refers to the ability of a material or element to support the formation of a magnetic field within itself, unless otherwise indicated. Furthermore, the term "permeability" can also be understood as the degree of magnetization a material acquires in response to an applied magnetic field. As used herein, a material having "high permeability" or "high magnetic permeability" means any material having a relative magnetic permeability that exceeds that of martensitic stainless steel, unless otherwise indicated.

[0039] The high permeability material described herein in relation to the present technology can be made of any material, with materials of higher permeability being more preferred. Magnetic field lines preferentially pass through materials with high permeability. Various embodiments of the present technology can use μ (Mu) metal, amorphous metal alloys (also known as metallic glass alloys), nanocrystalline metals, or 99.95% pure iron. Mu metal and one particular branch of Metglas® amorphous alloy (METGLAS is a registered trademark of Metglas, Inc., Conway, South Carolina) are both particularly well suited for use with the cores of the present disclosure. Compared to air, which has a permeability equal to 1 (i.e. μ=1), it has been found that mu metal has a relative permeability of about 50,000, while 99.95% pure iron has a relative permeability of about 200,000.

[0040] As shown in FIG. 4B, the high permeability planar member (450A) may be attached or placed over the electrode pad (422) and at least one of the first coil (410) and the second coil (412) of the position sensor (127) (FIG. 4B shows the high permeability planar member (450A) placed over the second coil (412). The high permeability planar member (450A) may have a dimensional footprint that may be larger, smaller, or equal to the area of ​​at least one of the first spiral coil (410, 412). It should be understood that the high permeability planar member (450A) may also be placed or attached over the electrode pad (420) and the first coil (410) on the opposite side with the same dimensional footprint as shown in FIG. 4B. It should be noted that while the position sensor (127) is shown in a flat pattern, the sensor (127) may be wrapped around a cylindrical member in its final operating configuration. As previously described, attaching or disposing the high permeability planar member (450A) relative to the first coil and / or second coil (410, 412) of the position sensor (127) may significantly increase the magnetic sensitivity of the position sensor (127), particularly due to the high permeability characteristics of the material composition of the high permeability planar member (450A). In some embodiments, the high permeability planar member (450A) may include mu-metal and / or Metglas® amorphous alloy (METGLAS is a registered trademark of Metglas, Inc., Conway, South Carolina), as previously described. Increasing the magnetic sensitivity of the position sensor (127) can be advantageous because it can provide the physician (24) with greater position accuracy of the distal end (28) of the handle (100) when within the patient's (23), such as within the vasculature of the patient's (23). Additionally, by increasing the magnetic sensitivity of the position sensor (127), a smaller position sensor (127) can be used to determine the position of the end effector (140).

[0041] As shown in FIG. 4C, the high permeability planar member (450B) may be attached or placed on the electrode pad (422) and the second coil (412) of the position sensor (127) in some examples, and may have a dimensional footprint that is equal to or smaller than the area of ​​at least one of the first and second spiral coils (410, 412). In other words, FIG. 4C shows the high permeability planar member (450B) having an area smaller than the area of ​​the high permeability planar member (450A) shown in FIG. 4B. As one skilled in the art will appreciate, adjusting the size of the high permeability planar member (450B) may affect the overall magnetic sensitivity of the position sensor (127). In other words, the size of the high permeability planar member (450B) will affect the overall magnetic sensitivity observed by the position sensor (127), which will be described in more detail herein.

[0042] FIG. 4D is a perspective view of a high permeability material disposed between two position sensors (127). In some examples, the high permeability material (450) may be compressed between the first coil (410) and the second coil (412) as shown in FIG. 4D. As will be appreciated by those skilled in the art, disposing the high permeability material (450) between the first coil (410) and the second coil (412) can increase the magnetic sensitivity of both the first coil (410) and the second coil (412). Furthermore, optimizing the size of the first coil (410) and the second coil (412) in combination with mounting or disposing the high permeability material (450) in or on the position sensor (127) can increase the magnetic sensitivity of the position sensor (127) as described above.

[0043] FIG. 4E is a perspective view of the position sensor (127) and the high permeability material attached to the position sensor (127). As previously mentioned, the position sensor (127) can include a flexible substrate (402), which can be deformed to conform the position sensor (127) to a number of shapes, configurations, etc. In some embodiments, as shown in FIG. 4E, the flexible substrate (402) and the high permeability material (450) can be deformed around the tubular shaft (120). The high permeability material (450) can be positioned on the position sensor (127) such that the high permeability material (450) is aligned along an axis (A) that passes through the centers of the first and second coils (410, 412). In this manner, the high permeability material (450) can be configured to increase the sensitivity of both the first and second coils (410, 412). The position sensor (127) may also include one or more leads (413) that may be configured to relay electrical signals obtained from the position sensor (127) to the system (10).

[0044] Although shown in FIGS. 4B-4E as having a first coil (410) and a second coil (412), the techniques of the present disclosure may be applicable to position sensor (127) having a single coil or multiple coils. For example, position sensor (127) may have a single coil with a high magnetic permeability material disposed on or near the single coil. Alternatively, position sensor (127) may have two, three, four, five, or even more coils, with each, some, or only one of the coils having a high magnetic permeability material disposed on or near the coil. Thus, while specific examples are disclosed herein, it will be understood that several variations of position sensor (127) are considered to be within the scope of the present disclosure.

[0045] FIG. 5A is a photograph of a position sensor assembly having a high permeability material disposed between two position sensors (127). FIG. 5B is a radiograph of the position sensor assembly shown in FIG. 5A. Similar to FIG. 4B, the high permeability planar member (450A) shown in FIG. 5A and FIG. 5B has a dimensional footprint that may be equal to or greater than the area of ​​one of the first and second spiral coils (410, 412). FIG. 5C is a photograph of another exemplary position sensor assembly having a high permeability material disposed between two position sensors. FIG. 5D is a radiograph of the position sensor assembly shown in FIG. 5C. Similar to FIG. 4C, the high permeability material (450B) shown in FIG. 5C and FIG. 5D has a dimensional footprint that may be smaller than the area of ​​one of the first and second spiral coils (410, 412) as shown in FIG. 5C and FIG. 5D.

[0046] FIG. 6 is a multivariate graph showing the relationship between concentration of high permeability material (450) and various cores as compared to a magnetic sensor without the high permeability material (450). As shown in FIG. 6, each panel represents a magnetic sensor (127) having various concentrations of high permeability material (450) cores attached. The first panel (602), entitled "Large Mu," represents three test data samples for a magnetic sensor assembly with a large concentration of high permeability material (450) attached. The first panel (602) may represent data collected using the position sensor (127) shown in FIGS. 5A and 5B, which has a relatively large amount of high permeability material (450). The second panel (604), entitled "No Mu," represents three test data samples for a magnetic sensor assembly without the high permeability material (450) attached. The third panel (606), titled "Small Mu," represents three test data samples for a magnetic sensor assembly having a low concentration of high permeability material (450) attached, which may be understood as a higher concentration of high permeability material (450) than the second panel (604) and a lower concentration than the first panel (602). The third panel (606) may represent data collected using the position sensor (127) shown in Figures 5C and 5D, which has a relatively small amount of high permeability material (450).

[0047] As shown in Figure 6, the magnetic sensitivity of the position sensor (127) having a large amount of high permeability material (450) has increased sensitivity compared to position sensors (127) having no or small amounts of high permeability material (450). The magnetic sensitivity is represented on the Y-axis as "delta per mil", where "delta per mil" is understood to mean the change in magnetic sensitivity per millimeter of high permeability material (450). In other words, as the size of the high permeability material (450) increases, the sensitivity of the position sensor (127) also increases.

[0048] FIG. 7 is a multivariate graph showing the relationship between magnetic sensitivity, concentration of high permeability material (450), and frequency of the magnetic field. As shown in FIG. 7, each panel of the multivariate graph examines the magnetic sensitivity of each magnetic sensor assembly based on the concentration of high permeability material (450) at a given frequency. The first panel (702) represents three data sets obtained using three different position sensor (127) assemblies at a first frequency, each respective assembly having a high, no, or low concentration of high permeability material (450). The second panel (704) represents three position sensor (127) assemblies at a second frequency, each assembly having a high, no, or low concentration of high permeability material (450). The third panel (706) represents three position sensor (127) assemblies at a third frequency, each having a high concentration, none, or a low concentration of high permeability material (450). As shown in FIG. 7, the "Large Mu" concentration at each of the frequencies resulted in the highest magnetic sensitivity when compared to the "Nu Mu" and "Small Mu" concentrations of high permeability material (450). Additionally, as shown in FIG. 7, the position sensor (127) assemblies having a low concentration of high permeability material (450) had a higher sensitivity than the position sensor (127) assemblies without the high permeability material (450).

[0049] FIG. 8 is a table showing the magnetic sensitivity of various concentrations of high permeability material (450) for three sample position sensor (127) assemblies. Similar to FIG. 7, each panel of FIG. 8 provides tabular data representing a position sensor (127) assembly having various concentrations of high permeability material (450) at a given frequency. A first section (802) shows the magnetic sensitivity of the magnetic sensor (127) without the high permeability material (450), which may also be understood as "No Mu." A second section (804) shows the magnetic sensitivity of the magnetic sensor (127) with a large concentration of high permeability material (450), which may also be understood as "Big Mu." A third section (806) shows the magnetic sensitivity of the magnetic sensor (127) with a low concentration of high permeability material (450), which may also be understood as "Small Mu." Similar to the conclusions that can be drawn from Figure 7, the magnetic sensitivity of the magnetic sensor (127) with "Big Mu" is shown to be higher than the magnetic sensitivity of the "Small Mu" and "No Mu" position sensor (127) assemblies. In other words, it can be seen that increasing the size of the high permeability material (450) attached to the position sensor (127) is directly proportional to the overall magnetic sensitivity of the position sensor (127).

[0050] As shown in Figure 8, second section (804), which represents a position sensor (127) assembly similar to that shown in Figures 5A and 5B having a greater concentration of high magnetic permeability material (450), had greater magnetic sensitivity as compared to position sensors (127) having no or lesser amounts of high magnetic permeability material (450). For example, each of the rows in the "Delta (%)" column of second section (804) in Figure 8 shows a value of over 200%, which represents a significant increase in magnetic sensitivity for the position sensor (127) assembly having a greater concentration of high magnetic permeability material (450).

[0051] The third section (806) of FIG. 8 represents a position sensor (127) assembly similar to that shown in FIGS. 5C and 5D, and had a higher magnetic sensitivity than the position sensor (127) assembly of the first section (802) without the high magnetic permeability material (450). However, the position sensor (127) assembly of the third section (806) of FIG. 8 had a relatively lower magnetic sensitivity than the position sensor (127) assembly of the second section (804). For example, each row in the "Delta (%)" column of the third section (806) of FIG. 8 was less than each row in the "Delta (%)" column of the second section (804), but still represents an increase over the position sensor (127) without the high magnetic permeability material. In other words, any presence of the high magnetic permeability material (450) mounted on the position sensor (127) assembly increases the magnetic sensitivity of the position sensor (127) assembly.

[0052] FIG. 9A is a perspective view of an exemplary end effector assembly (900) including an electrode (930) and a position sensor (127) assembly. FIG. 9B is a perspective view of the position sensor (127) assembly shown in FIG. 9A. The end effector assembly (900) may include a generally planar shape when deployed from a delivery sheath to an open configuration as shown in FIG. 9A. It should be understood that the end effector assembly (900) may be in a closed configuration while compressed within a delivery sheath and then transition to the deployed configuration shown in FIG. 9A. The end effector assembly (900) may be configured to transition to and maintain the geometric shape observed while in the open configuration by having a support structure (910) formed from a plurality of spines. In some embodiments, the support structure may be formed from Nitinol, which is known within the relevant art to have shape memory properties. One method of shape setting Nitinol may be by a time and temperature heat curing process to ensure that the support structure (910) is configured to maintain a predetermined shape. In other words, a Nitinol support structure (910) as shown in Figure 9A can be shape-set through a time and temperature heat curing process, however, it should be understood that another suitable elastic material, such as polyetherimide (PEI), can also be the material composition of the support structure (910).

[0053] The end effector assembly (900) may also include a polymer (920) that may be disposed over the support structure (910) and may assist in supporting the end effector assembly (900). The end effector assembly (900) may also include a plurality of electrodes (930) that may be disposed along the generally planar shape of the end effector assembly (900) in an arrangement of one or more rows, as shown in FIG. 9A. At least some of the plurality of electrodes (930) may be configured to detect electrophysiological signals when the end effector assembly (900) contacts tissue within the patient's (23) body. Alternatively, or in addition, at least some of the plurality of electrodes (930) may be configured to deliver ablation energy to tissue.

[0054] The end effector assembly (900) may also include a coil (940) that may be configured to generate an induced voltage when a magnetic field is applied to the end effector assembly (900). The coil (940) may include a first coil (940A), a second coil (940B), and a third coil (940C). In some embodiments, as shown in FIG. 9B, the first coil (940A) may be disposed on a first side of the end effector assembly (900), the second coil (940B) may be disposed on a second side of the end effector assembly (900), and the third coil (940C) may be disposed near a distal end of the end effector assembly (900).

[0055] 9C and 9D are perspective views of the position sensor (127) and the high magnetic permeability material of FIGS. 9A and 9B. In some examples, the high magnetic permeability material (950A) can be impregnated into at least a portion of the end effector assembly (900), as shown in FIG. 9C. The impregnated high magnetic permeability material (950A) can be disposed as separate pieces of high magnetic permeability material (950A) near the first coil (940A), the second coil (940B), and the third coil (940C), as also shown in FIG. 9C. In some examples, the end effector (900) can include the high magnetic permeability material (950B) printed in a zigzag pattern on the end effector assembly (900). The zigzag pattern can start at the proximal end of the end effector assembly (900) and can extend to the distal end of the end effector assembly (900), as shown in FIG. 9D.

[0056] 10 is a perspective view of another exemplary end effector assembly (1000) with a high magnetic permeability material having sensor assemblies distributed in an alternating configuration. As shown in FIG. 10, the end effector assembly (1000) can have a body having a generally planar shape. In some embodiments, the end effector assembly (1000) can also have a plurality of first electrode assemblies (1030) and a plurality of second electrode assemblies (1040). The plurality of first electrode assemblies (1030) can be disposed along the body of the end effector (1000) and can be configured to detect electrophysiological signals and / or distribute ablation energy to tissue. A plurality of second electrode assemblies (1040) may also be arranged along the body of the end effector assembly (1000), and each of the plurality of second electrode assemblies (1040) may include an electrode (1130), a coil (1140) (shown in FIG. 11), and a member (950) formed from a high magnetic permeability material (450).

[0057] Each electrode (1130) of the plurality of second electrode assemblies (1040) may be configured to detect electrophysiological signals and / or deliver ablation energy to tissue, as described above with respect to the plurality of first electrode assemblies (1030). The coil (940) of each of the plurality of second electrode assemblies (1040) may be configured to generate an induced voltage when exposed to a magnetic field and may be disposed on the body of the end effector assembly (900). The member (950) formed of a high magnetic permeability material (450) for each of the plurality of second electrode assemblies (1040) may be disposed on at least one side of the body of the end effector assembly (900). In some embodiments, the plurality of first electrode assemblies (1030) and the plurality of second electrode assemblies (1040) may be arranged in a horizontal alternating row pattern, as shown in FIG. 10. It should be understood that the plurality of first electrode assemblies (1030) and the plurality of second electrode assemblies (1040) may also be arranged in an alternating row-by-row arrangement. In other words, each row may include one of the plurality of first electrode assemblies (1030) followed by one of the plurality of second electrode assemblies (1040) across the length (A), as shown in FIG. 10. It should also be understood that the plurality of first electrode assemblies (1030) and the plurality of second electrode assemblies (1040) may be arranged in a vertical alternating row pattern.

[0058] FIG. 11A is a top view of an electrode assembly (1100) having a high magnetic permeability material (1150). FIG. 11B is a cross-sectional view of the electrode assembly (1100) shown in FIG. 11A along line AA having a high magnetic permeability material (1150). FIG. 11C is a bottom view of the electrode assembly having a high magnetic permeability material (1150) shown in FIGS. 11A and 11B. In some embodiments, the electrode assembly (1100) may include an electrode (1130) that may be configured to detect an electrophysiological signal. The electrode assembly (1130) may also include a planar substrate (1120) as shown in FIG. 11A, with the electrode (1130) disposed on a first side of the planar substrate (1120). The electrode assembly (1100) may also include an electromagnetic coil (1140) that may be disposed on a second side of the planar substrate (1120) as shown in FIGS. 11B and 11C. The electromagnetic coil (1140) can be configured to provide a voltage when exposed to a magnetic field and can have a helical shape that can have a width approximately equal to the width of the electrode (1130), as shown in FIG. 11C.

[0059] The electrode assembly (1100) may also include a high magnetic permeability member (1150). In some embodiments, the high magnetic permeability member (1150) may be disposed on the opposite side of the electromagnetic coil (1140) from the planar substrate (1120), as shown in FIG. 11B. Alternatively, the high magnetic permeability member (1150) may be disposed between the electromagnetic coil (1140) and the planar substrate (1120). It should also be understood that the size of the high magnetic permeability member (1150) attached to the electromagnetic coil (1140) may be directly proportional to the resulting magnetic sensitivity of the electromagnetic coil (1140). In other words, a larger high magnetic permeability member (1150) may result in an increased magnetic sensitivity to the electromagnetic coil (1140), which may increase the position sensing performance of the electrode assembly (1100).

[0060] FIG. 12A is a cross-sectional view of an electrode assembly (1200) having a high magnetic permeability material (1250), and FIG. 12B is a cross-sectional view of an electrode assembly (1200) having a high magnetic permeability material (1250). FIG. 12C is an alternative cross-sectional view of an electrode assembly (1200) having a high magnetic permeability material (1250). In some examples, the electrode assembly (1200) can include an electrode (1230), a high magnetic permeability material member (1250), and an electromagnetic coil (1240), as shown in FIGS. 12A-12C. As shown in FIG. 12A, the electrode (1230) can be gold plated, for example, and the high magnetic permeability material member (1250) can be at least partially disposed within the electrode (1230). The electrode assembly (1200) can also include a conductive polymer (1260), which can be disposed on top of the electrode (1230), as shown in FIG. 12B. In some embodiments, the conductive polymer (1260) may be formed from the polymer poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS). It is understood that there are other suitable conductive polymers known in the relevant art that may be utilized in the present technology.

[0061] The electrode assembly (1200) may also include a coverlay biocompatible adhesive (1270) that may be disposed over the electrode (1230) and proximate to the conductive polymer (1260), as shown in FIG. 12B. The electrode assembly (1200) may also include a substrate (1220) having a generally planar shape that may be disposed under the electrode (1230), as shown in FIG. 12B and FIG. 12C. In some embodiments, a high magnetic permeability material member (1250) may be disposed within the substrate (1220) between the electrode (1230) and the plurality of electromagnetic coils (1240), as shown in FIG. 12C. As previously mentioned, the plurality of electromagnetic coils (1240) may have a generally helical shape that may have a width approximately equal to the width of the electrode (1230).

[0062] The techniques of the present disclosure described herein can be further understood according to the following sections.

[0063] Clause 1: A magnetic position sensor comprising: a first spiral coil and a second spiral coil arranged on a planar substrate, the first spiral coil and the second spiral coil being arranged around a first central axis and a second central axis of the first spiral coil and the second spiral coil, respectively, and each of the first spiral coil and the second spiral coil being configured to generate a voltage when exposed to a magnetic field; and a high permeability planar member arranged near one of the first spiral coil and the second spiral coil, the high permeability planar member being positioned on an intersection of the first central axis and the second central axis when the planar coil is wound around a cylindrical substrate.

[0064] Clause 2: The magnetic position sensor of clause 1, wherein the high magnetic permeability planar member comprises an area that is less than or equal to an area of ​​one of the first spiral coil and the second spiral coil.

[0065] Clause 3: A magnetic position sensor as described in clause 1, wherein the high magnetic permeability planar member includes an area equal to or greater than the area of ​​one of the first spiral coil and the second spiral coil.

[0066] Clause 4: A magnetic position sensor as described in any one of clauses 1 to 3, wherein the high magnetic permeability planar member comprises mu metal.

[0067] Clause 5: A magnetic position sensor as described in any one of clauses 1 to 3, wherein the high magnetic permeability planar member comprises Metglas material.

[0068] Clause 6: A magnetic position sensor described in any one of clauses 1 to 4, wherein the high permeability planar member includes a high permeability material printed along at least a portion of the planar substrate near one of the first spiral coil and the second spiral coil.

[0069] Clause 7: A magnetic position sensor as described in clause 6, wherein the high magnetic permeability material is printed in a zigzag pattern along the planar substrate.

[0070] Clause 8: A magnetic position sensor described in any one of clauses 1 to 7, wherein the magnetic position sensor further comprises a plurality of separate high permeability members suspended within the non-conductive material along at least a portion of one of the first spiral coil and the second spiral coil.

[0071] Clause 9: An electrode assembly comprising: a planar substrate extending along a plane; an electrode disposed on the planar substrate and configured to detect an electrophysiological signal; an electromagnetic coil disposed on the planar substrate and configured to generate a voltage when exposed to a magnetic field; and a member including a high magnetic permeability material disposed near the electromagnetic coil.

[0072] Clause 10: An electrode assembly as described in clause 9, wherein the electrode is disposed on a first side of the planar substrate and the electromagnetic coil is disposed on a second side of the planar substrate.

[0073] Clause 11: An electrode assembly as described in clause 10, wherein the member is disposed on a side of the electromagnetic coil opposite the planar substrate.

[0074] Clause 12: An electrode assembly as described in clause 10, wherein the member is disposed between the electromagnetic coil and the planar substrate.

[0075] Clause 13: The electrode assembly of claim 10, wherein the member is disposed between the electrode and the planar substrate.

[0076] Clause 14: An electrode assembly described in any one of clauses 9 to 13, wherein the electromagnetic coil comprises a spiral shape having a width approximately equal to the width of the electrode.

[0077] Clause 15: An electrode assembly as described in clause 10, wherein the member is at least partially disposed within the substrate between the electrode and the electromagnetic coil.

[0078] Clause 16: An electrode assembly as described in clause 10, wherein the member is at least partially disposed within the electrode on the first side of the substrate.

[0079] Clause 17: An electrode assembly described in any one of clauses 9 to 16, further comprising a conductive polymer material disposed along an outer surface of the electrode.

[0080] Clause 18: An electrode assembly according to any one of clauses 9 to 17, wherein the high magnetic permeability material comprises mu metal.

[0081] Clause 19: An electrode assembly according to any one of clauses 9 to 17, wherein the high magnetic permeability material comprises a Metglas material.

[0082] Clause 20: An end effector, comprising: a plurality of electrodes disposed along the end effector and configured to detect electrophysiological signals; and a coil disposed along the end effector and configured to generate a voltage when exposed to a magnetic field; a member disposed near the coil and including a high magnetic permeability material.

[0083] Clause 21: An end effector as described in Clause 21, wherein the end effector comprises a generally planar shape, a plurality of electrodes arranged in one or more rows along the generally planar shape, and a coil arranged generally along the periphery of the generally planar shape.

[0084] Clause 22: The end effector described in Clause 21, further comprising a first coil disposed on a first side of the end effector, a second coil disposed on a second side of the end effector, and a third coil disposed near a distal portion of the end effector.

[0085] Clause 23: An end effector as described in clause 22, wherein the member includes a high magnetic permeability material printed along at least a portion of the generally planar shape near at least one of the first coil, the second coil, and the third coil.

[0086] Clause 24: An end effector as described in clause 23, wherein the high magnetic permeability material is printed in a zigzag pattern from a periphery of the generally planar proximal end to a periphery of the generally planar distal end.

[0087] Clause 25: An end effector described in any one of clauses 20 to 24, wherein the member further comprises a plurality of separate members suspended within the non-conductive material along at least a portion of the generally planar shape.

[0088] Clause 26: The end effector of clause 20, further comprising a substrate, a plurality of electrodes being disposed on a first side of the substrate, and a coil being disposed on a second side of the substrate near at least one of the plurality of electrodes.

[0089] Clause 27: An end effector as described in clause 26, wherein the member is disposed on an opposite side of the coil from the substrate.

[0090] Clause 28: An end effector as described in clause 26, wherein the member is disposed between the coil and the substrate.

[0091] Clause 29: An end effector as described in clause 26, wherein the member is disposed between the electrode and the substrate.

[0092] Clause 30: An end effector described in any one of clauses 26 to 29, wherein the coil comprises a generally helical shape having a width approximately equal to the width of the electrode.

[0093] Clause 31: An end effector as described in clause 26, wherein the member is at least partially disposed within the substrate between the electrode and the coil.

[0094] Clause 32: An end effector as described in clause 26, wherein the member is at least partially disposed within an electrode on a first side of the substrate.

[0095] Clause 33: An end effector described in any one of clauses 26 to 32, further comprising a conductive polymer material disposed along an outer surface of the electrode.

[0096] Clause 34: An end effector described in any one of clauses 20 to 33, wherein the high magnetic permeability material includes mu metal.

[0097] Clause 35: An end effector described in any one of clauses 20 to 33, wherein the high magnetic permeability material comprises a Metglas material.

[0098] Clause 36: An end effector described in any one of clauses 20 to 35, further comprising an insulating substrate disposed between the plurality of electrodes and the coil.

[0099] Clause 37: An end effector described in any one of clauses 20 to 36, further comprising an insulating material disposed between the plurality of electrodes and the member.

[0100] Clause 38: An end effector comprising: a body having a generally planar shape; a plurality of first electrode assemblies disposed along the body and configured to detect an electrophysiological signal; a plurality of second electrode assemblies disposed along the body, each electrode assembly of the plurality of second electrode assemblies configured to detect an electrophysiological signal; a coil disposed on the body and configured to generate a voltage when exposed to a magnetic field; and a member including a high magnetic permeability material disposed on at least one side of the body.

[0101] Clause 39: An end effector as described in clause 38, wherein the plurality of first electrode assemblies and the plurality of second electrode assemblies are arranged in an alternating pattern along the body.

[0102] Clause 40: An end effector described in clause 38 or 39, wherein a plurality of first electrode assemblies and a plurality of second electrode assemblies are arranged on the first side of the body and the second side of the body in an alternating pattern.

[0103] Clause 41: An end effector described in any one of clauses 38 to 40, wherein the alternating pattern includes a plurality of first electrode assemblies arranged in a first row and a plurality of second electrode assemblies arranged in a second row.

[0104] Clause 42: An end effector described in any one of clauses 38 to 40, wherein each electrode assembly of the plurality of second electrode assemblies comprises an electrode disposed on a first side of the substrate and a coil disposed on a second side of the substrate.

[0105] Clause 43: An end effector as described in clause 42, wherein the member is disposed on an opposite side of the coil from the substrate.

[0106] Clause 44: An end effector as described in clause 42, wherein the member is disposed between the coil and the substrate.

[0107] Clause 45: An end effector as described in clause 42, wherein the member is disposed between the electrode and the substrate.

[0108] Clause 46: An end effector described in any one of clauses 42 to 45, wherein the coil comprises a spiral shape having a width approximately equal to the width of the electrode.

[0109] Clause 47: An end effector as described in clause 42, wherein the member is at least partially disposed within the substrate between the electrode and the coil.

[0110] Clause 48: An end effector as described in Clause 42, wherein the member is at least partially disposed within the electrode on the first side of the substrate.

[0111] Clause 49: An end effector described in any one of clauses 42 to 48, further comprising a conductive polymer material disposed along an outer surface of the electrode.

[0112] Clause 50: An end effector described in any one of clauses 38 to 49, wherein the high magnetic permeability material includes mu metal.

[0113] Clause 51: An end effector comprising: a plurality of flexible spines, the plurality of flexible spines configured to transition the end effector between an extended configuration and a folded configuration; a plurality of electrode assemblies disposed along the plurality of flexible spines, each electrode assembly of the plurality of electrode assemblies comprising a substrate extending at least partially along a spine of the plurality of flexible spines; an electrode disposed on a first side of the substrate and configured to detect an electrophysiological signal; a coil disposed on a second side of the substrate and configured to generate a voltage when exposed to a magnetic field; and a member comprising a high magnetic permeability material.

[0114] Clause 52: An end effector as described in clause 51, wherein the member is disposed on an opposite side of the coil from the substrate.

[0115] Clause 53: An end effector as described in clause 51, wherein the member is disposed between the coil and the substrate.

[0116] Clause 54: An end effector as described in Clause 51, wherein the member is disposed between the electrode and the substrate.

[0117] Clause 55: An end effector described in any one of clauses 51 to 54, wherein the coil comprises a generally helical shape having a width approximately equal to the width of the electrode.

[0118] Clause 56: An end effector as described in Clause 51, wherein the member is at least partially disposed within the substrate between the electrode and the coil.

[0119] Clause 57: An end effector as described in Clause 51, wherein the member is at least partially disposed within an electrode on a first side of the substrate.

[0120] Clause 58: An end effector described in any one of clauses 51 to 57, further comprising a conductive polymer material disposed along an outer surface of the electrode.

[0121] Clause 59: An end effector described in any one of clauses 51 to 58, wherein the high magnetic permeability material includes mu metal.

[0122] Clause 60: An end effector described in any one of clauses 51 to 58, wherein the high magnetic permeability material comprises a Metglas material.

[0123] Any of the examples or embodiments described herein may include various other features in addition to or in place of those described above. The teachings, representations, embodiments, examples, etc. described herein should not be considered in isolation with respect to each other. Various suitable ways in which the teachings herein can be combined should be apparent to one of ordinary skill in the art in view of the teachings herein.

[0124] Although exemplary embodiments of the subject matter encompassed by the present invention have been shown and described, further adaptations of the methods and systems described herein can be achieved by appropriate modifications without departing from the scope of the claims. Moreover, where the above methods and steps show certain events occurring in a particular order, it is intended that the specific steps need not be performed in the order described, but rather in any order as long as the steps enable the embodiments to function for their intended purpose. Thus, to the extent there are variations of the invention that are within the spirit of the disclosure or equivalent to the invention found in the claims, this patent is intended to cover those variations as well. Some such modifications should be apparent to those skilled in the art. For example, the above examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. are exemplary. Thus, the claims should not be limited to the specific details of structure and operation set forth in the specification and drawings.

[0125] [Embodiment] (1) A magnetic position sensor comprising: a first spiral coil and a second spiral coil disposed on a planar substrate, the first spiral coil and the second spiral coil being disposed about respective first and second central axes of the first spiral coil and the second spiral coil, each of the first spiral coil and the second spiral coil being configured to generate a voltage when exposed to a magnetic field; a high permeability planar member disposed near one of the first spiral coil and the second spiral coil, the high permeability planar member being disposed at an intersection of the first central axis and the second central axis when the planar coil is wound around a cylindrical substrate. (2) The magnetic position sensor of embodiment 1, wherein the high magnetic permeability planar member has an area that is less than or equal to an area of ​​one of the first spiral coil and the second spiral coil. (3) The magnetic position sensor of embodiment 1, wherein the high magnetic permeability planar member includes an area equal to or greater than the area of ​​one of the first spiral coil and the second spiral coil. (4) The magnetic position sensor of embodiment 1, wherein the high magnetic permeability planar member comprises a mu metal. (5) A magnetic position sensor as described in embodiment 1, wherein the high magnetic permeability planar member comprises a Metglas material.

[0126] (6) A magnetic position sensor as described in embodiment 1, wherein the high magnetic permeability planar member includes a high magnetic permeability material printed along at least a portion of the planar substrate near the one of the first spiral coil and the second spiral coil. (7) A magnetic position sensor as described in embodiment 6, wherein the high magnetic permeability material is printed in a zigzag pattern along the planar substrate. (8) The magnetic position sensor of embodiment 1, further comprising a plurality of separate high magnetic permeability members suspended within a non-conductive material along at least a portion of one of the first spiral coil and the second spiral coil. (9) An electrode assembly comprising: a planar substrate extending along a plane; an electrode disposed on the planar substrate and configured to detect an electrophysiological signal; an electromagnetic coil disposed on the planar substrate and configured to generate a voltage when exposed to a magnetic field; a member including a high magnetic permeability material disposed proximate the electromagnetic coil. (10) The electrode assembly of embodiment 9, wherein the electrode is disposed on a first side of the planar substrate and the electromagnetic coil is disposed on a second side of the planar substrate.

[0127] (11) The electrode assembly of claim 10, wherein the member is disposed on an opposite side of the electromagnetic coil from the planar substrate. (12) The electrode assembly of claim 10, wherein the member is disposed between the electromagnetic coil and the planar substrate. (13) The electrode assembly of claim 10, wherein the member is disposed between the electrode and the planar substrate. (14) The electrode assembly of claim 9, wherein the electromagnetic coil comprises a spiral shape having a width approximately equal to a width of the electrode. (15) An end effector comprising: a plurality of electrodes disposed along the end effector and configured to detect electrophysiological signals; a coil disposed along the end effector and configured to generate a voltage when exposed to a magnetic field; a member disposed near the coil, the member including a high magnetic permeability material.

[0128] (16) The end effector of embodiment 15, wherein the end effector has a generally planar shape, the plurality of electrodes are arranged in one or more rows along the generally planar shape, and the coil is arranged generally along the periphery of the generally planar shape. (17) The end effector of embodiment 16, wherein the coil further comprises a first coil disposed on a first side of the end effector, a second coil disposed on a second side of the end effector, and a third coil disposed near a distal portion of the end effector. (18) The end effector of claim 17, wherein the member includes a high magnetic permeability material printed along at least a portion of the generally planar shape near at least one of the first coil, the second coil, and the third coil. (19) An end effector as described in embodiment 18, wherein the high magnetic permeability material is printed in a zigzag pattern from around the proximal end of the generally planar shape to around the distal end of the generally planar shape. (20) The end effector of claim 15, wherein the member further comprises a plurality of separate members suspended within the non-conductive material along at least a portion of the generally planar shape.

Claims

1. 1. A magnetic position sensor comprising: a first spiral coil and a second spiral coil disposed on a planar substrate, the first spiral coil and the second spiral coil being disposed about respective first and second central axes of the first spiral coil and the second spiral coil, each of the first spiral coil and the second spiral coil being configured to generate a voltage when exposed to a magnetic field; a high permeability planar member disposed near one of the first spiral coil and the second spiral coil, the high permeability planar member being disposed on an intersection of the first central axis and the second central axis when the planar coil is wound around a cylindrical substrate.

2. 2. The magnetic position sensor of claim 1, wherein the high magnetic permeability planar member comprises an area that is less than or equal to an area of ​​the one of the first spiral coil and the second spiral coil.

3. The magnetic position sensor of claim 1 , wherein the high magnetic permeability planar member comprises an area equal to or greater than an area of ​​the one of the first spiral coil and the second spiral coil.

4. The magnetic position sensor of claim 1 , wherein the high magnetic permeability planar member comprises a mu-metal.

5. The magnetic position sensor of claim 1 , wherein the high magnetic permeability planar member comprises a Metglas material.

6. 2. The magnetic position sensor of claim 1, wherein the high magnetic permeability planar member comprises a high magnetic permeability material printed along at least a portion of the planar substrate near the one of the first spiral coil and the second spiral coil.

7. The magnetic position sensor of claim 6 , wherein the high magnetic permeability material is printed in a zigzag pattern along the planar substrate.

8. 2. The magnetic position sensor of claim 1, further comprising a plurality of separate high magnetic permeability members suspended within a non-conductive material along at least a portion of one of the first spiral coil and the second spiral coil.

9. 1. An electrode assembly comprising: a planar substrate extending along a plane; an electrode disposed on the planar substrate and configured to detect an electrophysiological signal; an electromagnetic coil disposed on the planar substrate and configured to generate a voltage when exposed to a magnetic field; a member including a high magnetic permeability material disposed proximate the electromagnetic coil.

10. The electrode assembly of claim 9 , wherein the electrode is disposed on a first side of the planar substrate and the electromagnetic coil is disposed on a second side of the planar substrate.

11. The electrode assembly of claim 10 , wherein the member is disposed on an opposite side of the electromagnetic coil from the planar substrate.

12. The electrode assembly of claim 10 , wherein the member is disposed between the electromagnetic coil and the planar substrate.

13. The electrode assembly of claim 10 , wherein the member is disposed between the electrode and the planar substrate.

14. The electrode assembly of claim 9 , wherein the electromagnetic coil comprises a helical shape having a width approximately equal to a width of the electrode.

15. An end effector, a plurality of electrodes disposed along the end effector and configured to detect electrophysiological signals; a coil disposed along the end effector and configured to generate a voltage when exposed to a magnetic field; a member disposed near the coil, the member including a high magnetic permeability material.

16. 16. The end effector of claim 15, wherein the end effector comprises a generally planar shape, the plurality of electrodes are arranged in one or more rows along the generally planar shape, and the coil is arranged generally along a periphery of the generally planar shape.

17. 17. The end effector of claim 16, wherein the coils further comprise: a first coil disposed on a first side of the end effector, a second coil disposed on a second side of the end effector, and a third coil disposed near a distal portion of the end effector.

18. 20. The end effector of claim 17, wherein the member includes a high magnetic permeability material printed along at least a portion of the generally planar shape adjacent at least one of the first coil, the second coil, and the third coil.

19. The end effector of claim 18 , wherein the high magnetic permeability material is printed in a zigzag pattern from a periphery of the generally planar proximal end to a periphery of the generally planar distal end.

20. The end effector of claim 15 , wherein the member further comprises a plurality of separate members suspended within a non-conductive material along at least a portion of the generally planar shape.

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