Magnetic sensor sensitivity enhancement

Abstract

The disclosed technology includes a magnetic positioning sensor that may include a first helical coil and a second helical coil, which may be disposed on a planar substrate. The first and second helical coils may be disposed about respective first and second central axes, wherein each of the first and second coils may be configured to generate a voltage when subjected to a magnetic field. The magnetic positioning sensor may also include a high permeability planar member that may be disposed proximate to one of the first and second helical coils. The high permeability planar member may be disposed on the magnetic positioning sensor such that the high permeability planar member may be disposed on an intersection of the first central axis and the second central axis with the planar substrate wrapped around a cylindrical substrate.

Description

[0001] Cross-references to related patent applications

[0002] This application claims priority to and the benefits of U.S. Provisional Patent Application No. 63 / 519,970 (Agent File No.: BIO6837USPSP1–253757.000385), filed on August 16, 2023, under 35 U.S.C. §119(e), the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates generally to magnetic sensors, and more particularly to magnetically permeable materials disposed proximate to a magnetic sensor that can help increase the magnetic sensitivity of the magnetic sensor. Background Art

[0004] A magnetic sensor is a sensor capable of detecting the magnitude and changes of a radiated magnetic field and outputting an electrical signal indicating the detected magnitude and changes of the radiated magnetic field. Magnetic sensors include, but are not limited to, coil magnetic sensors, reed switches, Hall effect elements, magnetoresistive elements, superconducting quantum interference devices, and the like. Medical positioning systems make full use of magnetic sensors to track medical devices within a patient's body. Traditionally, in order to locate a medical device within a patient's body, a medical positioning system includes a magnetic field generator configured to radiate one or more magnetic fields to induce electrical signals from a magnetic sensor. The accuracy and reliability of a magnetic sensor are proportional to the strength of an induced voltage emitted by the magnetic sensor as an electrical signal. As a result, a larger induced voltage from a magnetic sensor provides greater resolution and accuracy to the medical positioning system via a stronger electrical signal.

[0005] 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 approach is that the additional windings or loops typically increase the size of the magnetic sensor. This makes some magnetic sensors too large and unsuitable for use in areas of medical devices where position sensing may be required. For example, the end effector of a catheter may not be able to support a current magnetic sensor due to the large size footprint of the magnetic sensor caused by increasing the number of windings or loops.

[0006] As will be appreciated, magnetic sensors with large footprints or lower induced voltages may result in incompatibility with medical devices and less accurate position data relayed to medical positioning systems.The technology disclosed herein addresses the aforementioned challenges. Summary of the invention

[0007] According to an example of the present technology, a magnetic positioning sensor is provided, which may include a first spiral coil and a second spiral coil, which may be disposed on a planar substrate. The first spiral coil and the second spiral coil may be disposed around a respective first central axis and a second central axis, wherein each of the first coil and the second coil may be configured to generate a voltage when subjected to a magnetic field. The magnetic positioning sensor may also include a high magnetic permeability planar member, which may be disposed near one of the first spiral coil and the second spiral coil. The high magnetic permeability planar member may be disposed on the magnetic positioning sensor so that, when the planar substrate is wrapped around a cylindrical substrate, the high magnetic permeability planar member may be disposed at the intersection of the first central axis and the second central axis.

[0008] According to an example of the present technology, an electrode assembly is provided, which may include a planar substrate, an electrode, an electromagnetic coil, and a component. The planar substrate may extend along a plane. The electrode may be disposed on the planar substrate and may be configured to detect an electrophysiological signal. The electromagnetic coil may be disposed on the planar substrate and may be configured to generate a voltage when subjected to a magnetic field. The component may include a high magnetic permeability material, which may be disposed near the electromagnetic coil.

[0009] According to an example of the present technology, an end effector is provided, which 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 subjected to a magnetic field. The member may be disposed near the coil and may include a high magnetic permeability material.

[0010] The end effector may have a generally planar shape, wherein the plurality of electrodes may be disposed in an arrangement in one or more rows along the generally planar shape.The coil may be disposed along an outer periphery of the generally planar shape of the end effector.

[0011] According to an example of the present technology, an end effector is provided, which 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 second plurality of electrode assemblies may be disposed along the body of the end effector.

[0012] Each 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 subjected to a magnetic field. The coil may include a helical shape having a width approximately equal to a width of the electrode. The member may include a high magnetic permeability material.

[0013] According to an example of the present technology, an end effector is provided, which may include a plurality of flexible ridges and a plurality of electrode assemblies. The plurality of flexible ridges may be configured to transition the end effector between an expanded configuration and a collapsed configuration. The plurality of electrode assemblies may be arranged along the plurality of flexible ridges, and each of the plurality of electrode assemblies may include a substrate, an electrode, a coil, and a member.

[0014] The substrate may extend at least partially along a ridge of the plurality of flexible ridges. The electrodes may be disposed on a first side of the substrate and may be configured to detect electrophysiological signals. The coil may be disposed on a second side of the substrate and may be configured to generate a voltage when subjected to a magnetic field. The member may include a high magnetic permeability material.

[0015] Additional features, functionality, and applications of the disclosed technology are discussed in greater detail herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 is a schematic illustration of a medical system including a catheter and a handle according to an example of the disclosed technology;

[0017] Figure 2 is a schematic illustration of a catheter and handle according to an example of the disclosed technology;

[0018] Figure 3 is a detailed view of an end effector of a catheter according to an example of the disclosed technology;

[0019] Figure 4A is a detailed view of a magnetic sensor according to an example of the disclosed technology;

[0020] Figure 4B is a detailed view of a magnetic sensor according to an example of the disclosed technology, wherein a high magnetic permeability material is attached to the magnetic sensor in a first configuration;

[0021] Figure 4C is an alternative detailed view of a magnetic sensor according to an example of the disclosed technology, wherein a high magnetic permeability material is attached to the magnetic sensor in a second configuration;

[0022] Figure 4D is a perspective view of a high magnetic permeability material disposed between two magnetic sensors according to an example of the disclosed technology;

[0023] Figure 4E 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;

[0024] Figure 5Ais a photograph of a magnetic sensor assembly according to an example of the disclosed technology, wherein a high magnetic permeability material is disposed between two magnetic sensors;

[0025] Figure 5B According to the example of the disclosed technology Figure 5A An X-ray view of a magnetic sensor assembly;

[0026] Figure 5C is a photograph of a magnetic sensor assembly according to another example of the disclosed technology, wherein a high magnetic permeability material is disposed between two magnetic sensors;

[0027] Figure 5D According to the example of the disclosed technology Figure 5C An X-ray view of a magnetic sensor assembly;

[0028] Figure 6 is a multivariate graph showing the relationship between the concentrations of high permeability materials having various magnetic cores according to an example of the disclosed technology;

[0029] Figure 7 is a multivariate graph showing the relationship between magnetic sensitivity and concentration of high permeability material according to an example of the disclosed technology;

[0030] Figure 8 is a table showing magnetic sensitivity at predetermined frequencies for various concentrations of high permeability material for three sample electrode assemblies according to an example of the disclosed technology;

[0031] Fig.9A 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;

[0032] Fig. 9B According to the example of the disclosed technology Fig.9A A perspective view of a magnetic sensor assembly;

[0033] Fig. 9C and Fig.9D is a high magnetic permeability material according to an example of the disclosed technology and Fig.9A and Fig. 9B A perspective view of a magnetic sensor;

[0034] Fig.10 is a perspective view of another exemplary end effector assembly according to an example of the disclosed technology, wherein the high magnetic permeability material is in an alternative configuration;

[0035] Fig.11A is a top view of an electrode assembly having a high magnetic permeability material according to an example of the disclosed technology;

[0036] Fig. 11B According to the example of the disclosed technology Fig.11A A cross-sectional view of an electrode assembly having a high magnetic permeability material is shown;

[0037] Fig. 11C is a bottom view of an electrode assembly having a high magnetic permeability material according to an example of the disclosed technology;

[0038] Fig. 12A is a cross-sectional view of an electrode assembly having a high magnetic permeability material according to an example of the disclosed technology;

[0039] Fig. 12B is a cross-sectional view of an electrode assembly having a high magnetic permeability material according to an example of the disclosed technology; and

[0040] Fig. 12C is another cross-sectional view of an electrode assembly having a high magnetic permeability material according to an example of the disclosed technology. DETAILED DESCRIPTION

[0041] 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 examples and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. This description will clearly enable those skilled in the art to prepare and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including the best modes currently believed to be implemented in the invention.

[0042] 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 range of ±20% of the value of the recited value, for example, "about 90%" may refer to a range of values ​​from 71% to 110%. In addition, as used herein, the terms "patient", "receptor", "user" and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but the use of the subject invention in human patients represents a preferred embodiment. 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.

[0043] As discussed herein, the vasculature of a "patient," "recipient," "user," and "subject" can be that of a human or any animal. It should be understood that the animal can be of any suitable type, including, but not limited to, a mammal, a veterinary animal, a livestock animal, or a pet animal, etc. For example, the animal can be a laboratory animal (e.g., a rat, dog, pig, monkey, etc.) that is specifically selected to have certain characteristics similar to those of a human. It should be understood that the subject can be, for example, any suitable human patient.

[0044] As discussed herein, a "physician" may include a physician, surgeon, technician, scientist, operator, or any other individual or delivery instrumentation associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.

[0045] It should be noted that the electrodes described and exemplified herein are not limited to mapping (i.e., sensing or recording signals) but can be used to deliver energy in bipolar or monopolar modes, such as RF (alternating cycle) or IRE (DC pulses), alone or in combination with mapping or sensing functions. In the application of IRE, the electrodes can be configured to deliver at least 900 V / electrode at a current of at least 20 amps in multiple pulses sufficient to cause apoptosis.

[0046] 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 reversible or irreversible electroporation (IRE), interchangeably referred to as pulsed electric fields (PEF) and pulsed field ablation (PFA) in the present disclosure) or thermal energy (such as radiofrequency (RF) ablation or cryoablation). "Ablation" as used throughout the present disclosure, when referring to the devices and corresponding systems of the present disclosure, refers to thermal ablation or 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.

[0047] Figure 1An example system (10) is shown that may include a catheter (14). The catheter (14) may be configured to navigate to the heart (12) of a patient (23) and to map and / or ablate myocardial tissue. The system (10) may be configured for multiple catheters that are inserted percutaneously through the vascular system of the patient (23) into a chamber or vascular structure of the heart (12) by a physician (24). Typically, the catheter (14) is inserted into the left atrium or right atrium near a desired location in the heart (12). Multiple catheters (14) may then be inserted into the catheter (14) to reach the desired location. The multiple 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 to sense IEGM is illustrated herein. The physician (24) contacts the distal end of the mapping catheter with the heart wall for sensing a target site in the heart (12). The end effector of the mapping catheter may include a basket catheter, a flat catheter, a focusing catheter, a balloon catheter, etc. For ablation, the physician (24) similarly brings the distal end of the ablation catheter to the target site for ablation. Similarly, the end effector of the ablation catheter may include a basket catheter, a flat catheter, a focusing catheter, a balloon catheter, etc.

[0048] The catheter (14) is an exemplary catheter that includes one and preferably a plurality of electrodes (127) that are optionally distributed on the distal end (28) of the catheter (14) for tracking the position and orientation of the catheter (14). Optionally and preferably, the electrode (127) can be a magnetic-based position sensor that includes three magnetic coils for sensing three-dimensional (3D) position and orientation. The catheter (14) may also include a position sensor that can be configured for impedance-based position tracking. Figure 2 As shown, the catheter (14) may include a handle (100) at its proximal end.

[0049] A magnetic-based position sensor (e.g., electrode 127) can operate with a positioning pad (25) that includes a plurality of magnetic coils (32) configured to generate a magnetic field in a predetermined working space. The real-time position of the distal end (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 (e.g., electrode 127). Details of magnetic-based position sensing technology are described in U.S. Patents 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, each of which is incorporated herein by reference.

[0050] The system (10) may include one or more electrode patches (38) positioned in contact with the skin of the patient (23) to establish a position reference for impedance-based tracking of the positioning pad (25) and electrodes (not shown). For impedance-based tracking, current is directed toward the 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.

[0051] The recorder (11) displays an electrogram (21) captured using surface ECG electrodes (18) and an intracardiac electrogram (IEGM) captured using electrodes (138) of the catheter (14). The recorder (11) may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.

[0052] The system (10) may include an ablation energy generator (50) adapted to conduct ablation energy to one or more electrodes at the distal end of a catheter configured for ablation. The energy generated by the ablation energy generator (50) may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that can be used to achieve irreversible electroporation (IRE)), or a combination thereof.

[0053] 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), an ablation energy generator (50), and a recorder (11). Optionally and preferably, the PIU (30) further includes processing capabilities for enabling real-time calculation of the position of the catheter and for performing ECG calculations.

[0054] The workstation (55) includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and a user interface capability. The workstation (55) can provide multiple functions, optionally including: (1) three-dimensional (3D) modeling of the endocardial anatomy and rendering the model or anatomical map (20) for display on a display device (27); (2) displaying on the 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 the display device (27) sites of interest, such as where ablation energy has been applied. A commercial product embodying elements of the system (10) can be CARTO TM 3System was purchased from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0055] Figure 2is a schematic illustration showing a perspective view of a catheter (100) according to the disclosed technology. The catheter (100) may be or include a catheter (14) identical to the catheter previously described. The catheter (100) may have a handle (110) at the proximal end of the catheter (100) and an end effector 140 disposed on the distal end (28) of the catheter (100). The catheter (100) may be configured for insertion and navigation into the vasculature of a patient to position the distal end (28) of the catheter (100) in a chamber of the patient's heart (12). The catheter assembly (100) may include a handle (110), a tubular shaft (120) extending distally from the handle (110), an end effector (140) located at the distal end (28) of the tubular shaft (120), and a deflection drive actuator (114) associated with the handle (110). As will be described in greater detail below, the end effector (140) includes various components configured to deliver ablation energy to a target tissue site, provide electrophysiological (EP) mapping functionality, detect external forces applied to the end effector (140), detect the position of the end effector (140), and / or disperse irrigation fluid. The deflection drive actuator (114) is rotatable relative to the housing (112) of the handle (110) and can deflect 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). Various suitable components that can be coupled to the deflection drive actuator (114) and the tubular shaft (120) to provide such functionality will be apparent to those skilled in the art in view of the teachings herein.

[0056] As previously described, at least the distal end (28) of the sheath (106) may 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) may be configured to deflect in one or more directions to enable manipulation of the catheter (100). For example, the catheter (100) may include one or more pull wires (not shown) attached to a deflection drive actuator (114) that is configured to pull the one or more pull wires when actuated to deflect the distal end (28), as will be understood by those skilled in the art.

[0057] The handle (100) may also include an irrigation supply tube (111) that may direct saline or other irrigation fluid from an irrigation supply device 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 for use via a cable or Figure 2 Other suitable electrical connections are shown to PIU (30).

[0058] Figure 3 An example end effector (140) of a catheter (100) is illustrated. However, Figure 3 The illustrated end effector (140) is provided for illustrative purposes and should not be construed as limiting. It should be understood that various other types of end effectors may be used in place of Figure 3 The end effector (140) is exemplified as a basket catheter, a flat catheter, a balloon catheter, a round catheter, a catheter with multiple ridges, etc. Figure 3 As shown, the distal tip (28) of the handle (100) may include a cylindrical body (156) having a domed tip. The cylindrical body (156) and the domed tip may be formed of a conductive material, such as a metal, and form an electrode configured to deliver ablative energy to tissue. A plurality of openings (158) may be formed through the cylindrical body (156) that communicate with the hollow interior of the distal tip (28). The openings (158) may allow irrigation fluid to be delivered from the interior of the distal tip (28) through the cylindrical body (156) to the exterior via an irrigation supply tube (111), such as Figure 2 and Figure 3 The cylindrical body (156) and dome tip are also operable to apply ablative electrical energy to tissue, thereby ablating the tissue. Such ablative electrical energy may be delivered from an ablative energy generator (50). The distal tip (28) may also include one or more thermocouples (not shown) that may be configured to provide temperature sensing capabilities. This may prevent overheating of the distal tip member (142) or adjacent tissue.

[0059] like Figure 3 As shown, the distal end member (28) of the catheter (100) may also include one or more electrophysiological (EP) mapping microelectrodes (138) mounted 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 a cardiovascular anatomical structure (e.g., pulmonary veins, etc.). The signals picked up by the EP mapping microelectrodes (138) may be transmitted to the PIU (30) via a cable. In accordance with the teachings of the various references cited herein, 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.

[0060] When the cylindrical body (156) is formed of a conductive material to provide ablative electrical energy for tissue ablation, an electrically insulating material may be inserted between the cylindrical body (156) and the EP mapping microelectrode (138), thereby electrically isolating the EP mapping microelectrode (138) from the cylindrical body (156). The EP mapping microelectrode (138) may be constructed and operated in accordance with the teachings of the various patent references cited herein. Although only one EP mapping microelectrode (138) is shown, the distal end (28) may include two or more EP mapping microelectrodes (138). Alternatively, the distal end member (142) may not have an EP mapping microelectrode (138) at all.

[0061] Figure 4A is a detailed view of a position sensor (127) (sometimes referred to herein as a "magnetic position sensor" or "magnetic sensor"). Figure 4A As shown, the position sensor (127) may include a flexible substrate (402) having a plurality of openings (404) formed therethrough. The flexible substrate (402) may be formed of a polyimide material, a liquid crystal polymer (LCP) material, and / or any other suitable type of material. The flexible substrate (402) may also include a tail portion (406). The electrode pads (420, 422) may be configured to contact the blood and measure the impedance of the blood, which may be used for sensing by impedance or for measuring an electrophysiological mapping reference signal in the blood. In some embodiments, the electrode pads (420, 422) may be used to obtain impedance measurements that may be used to provide position sensing, as disclosed in U.S. Patents 7,869,865 and 8,456,182, the disclosures of each of which are incorporated herein by reference in their entirety. As will be appreciated by those skilled in the art, the electrode pads (420, 422) may act as a second type of navigation sensor. In some scenarios, using electrode pads (420, 422) as a second type of navigation sensor may not be as accurate as a first type of navigation sensor (e.g., an electromagnetic type positioning sensor), and therefore it may be necessary to generate a position matrix before this second type of navigation sensor (e.g., impedance position sensing) can be viewed by an operator.

[0062] As a result, the impedance signals from the electrode pads (420, 422) can be used in conjunction with signals from a coil-based sensor (e.g., a navigation sensor formed by a first coil (410) and a second coil (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 to measure the impedance of the tissue for other purposes. Although the position sensor (127) includes only two electrode pads (420, 422) in this example, the position sensor (127) may alternatively include only one electrode pad or more than two electrode pads.

[0063] Figure 4B , Figure 4C and Figure 4D A detailed view of a position sensor (127) is shown with a high magnetic permeability material (450A, 450B) attached to the position sensor (127) in one or more configurations. As will be appreciated by one skilled in the art, a high magnetic permeability material can easily align itself with an applied magnetic field. Unless otherwise specified, "magnetic permeability" as used herein refers to the ability of a material or element to support the formation of a magnetic field within itself. Additionally, the term "magnetic permeability" may also be understood as the degree of magnetization that a material acquires in response to an applied magnetic field. Unless otherwise specified, a material having "high magnetic permeability" as used herein means any material having a relative magnetic permeability that is higher than the relative magnetic permeability of martensitic stainless steel.

[0064] The high permeability materials described herein with respect to the present technology can be made of any material, with higher permeability materials being more suitable. Magnetic field lines preferentially pass through materials with high permeability. In various embodiments of the present technology, μ (Mu) metals, amorphous metal alloys (also known as metallic glass alloys), nanocrystalline metals, or 99.95% pure iron can be used. Mu metals and A particular branch of amorphous alloys (METGLAS is a registered trademark of Metglas, Inc. of Conway, South Carolina) are particularly suitable for use with the magnetic cores of the present disclosure. Compared to air, which has a magnetic permeability of one (i.e., μ=1), it has been found that Mu metal has a relative magnetic permeability of about 50,000, while 99.95% pure iron has a relative magnetic permeability of about 200,000.

[0065] like Figure 4B As shown, the high magnetic permeability planar member (450A) can be attached or placed on the electrode pad (422) of the position sensor (127) and at least one of the first coil (410) and the second coil (412) ( Figure 4B A high permeability planar member (450A) is shown placed on top of the second coil (412). The high permeability planar member (450A) may have a size footprint that may be greater than, less than, or equal to the area of ​​at least one of the first spiral coil (410) and the second spiral coil (412). It should be understood that the high permeability planar member (450A) may also be placed or attached to the opposing electrode pad (420) and the first coil (410) with the same size footprint, such as Figure 4BAs shown. Although the position sensor (127) is shown in a flat pattern, it must be noted that the sensor (127) can be wrapped around a cylindrical member in its final operational form. As previously described, attaching or placing the high magnetic permeability planar member (450A) on the first coil and / or second coil (410, 412) of the position sensor (127) can greatly increase the magnetic sensitivity of the position sensor (127), particularly due to the high magnetic permeability properties of the material composition of the high magnetic permeability planar member (450A). In some embodiments, the high magnetic permeability planar member (450A) may include Mu metal and / or Amorphous alloy (METGLAS is a registered trademark of Metglas, Inc. of Conway, South Carolina). 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), for example, when inside the body of the patient (23), such as the vasculature of the patient (23). In addition, 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).

[0066] like Figure 4C As shown, in some examples, a high magnetic permeability planar member (450B) can be attached or placed on the electrode pad (422) and the second coil (412) of the position sensor (127), and the high magnetic permeability planar member has a size that is less than or equal to the area of ​​at least one of the first spiral coil (410) and the second spiral coil (412). In other words, Figure 4C A high magnetic permeability planar member (450B) is illustrated, the high magnetic permeability planar member having a magnetic field less than Figure 4B The area of ​​the high permeability planar member (450A) shown is 450A. As will be appreciated by those skilled in the art, adjustments to the size of the high permeability planar member (450B) can 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 in the position sensor (127), which will be described in more detail herein.

[0067] Figure 4D is a perspective view of a high magnetic permeability material disposed between two position sensors (127). In some examples, the high magnetic permeability material (450) may be compressed between the first coil (410) and the second coil (412), such as Figure 4DAs will be appreciated by those skilled in the art, by placing the high magnetic permeability material (450) between the first coil (410) and the second coil (412), the magnetic sensitivity of both the first coil (410) and the second coil (412) can be increased. In addition, optimization of the size of the first coil (410) and the second coil (412) combined with attaching or placing the high magnetic permeability material (450) within or on the position sensor (127) can increase the magnetic sensitivity of the position sensor (127), as previously discussed.

[0068] Figure 4E is a perspective view of a position sensor (127) and a high magnetic permeability material attached to the position sensor (127). As previously described, the position sensor (127) may include a flexible substrate (402) that is deformable to allow the position sensor (127) to conform to a variety of shapes, configurations, etc. In some embodiments, such as Figure 4E As shown, the flexible substrate (402) and the high magnetic permeability material (450) can be deformed around the tubular shaft (120). The high magnetic permeability material (450) can be positioned on the position sensor (127) so that the high magnetic permeability material (450) is aligned along an axis (A) passing through the center of the first coil (410) and the second coil (412). In this way, the high magnetic permeability material (450) can be configured to increase the sensitivity of both the first coil (410) and the second coil (412). The position sensor (127) can also include one or more wires (413), which can be configured to relay the electrical signal obtained from the position sensor (127) to the system (10).

[0069] Despite FIG. 4B to FIG. 4E , as having a first coil (410) and a second coil (412), the disclosed technology may be applicable to a position sensor (127) having a single coil or multiple coils. For example, the position sensor (127) may have a single coil, wherein a high magnetic permeability material is disposed on or near the single coil. Alternatively, the position sensor (127) may have two, three, four, five, or even more coils, wherein each coil, some coils, or only one coil of the coils has a high magnetic permeability material disposed on or near the coils. Therefore, although specific examples are disclosed herein, it should be understood that several variations of the position sensor (127) are also considered to be within the scope of the present disclosure.

[0070] Figure 5A is a photograph of a position sensor assembly in which a high magnetic permeability material is disposed between two position sensors (127). Figure 5B yes Figure 5A Radiograph of the position sensor assembly shown. Similar to Figure 4B ,like Figure 5A and Figure 5BThe high magnetic permeability planar member (450A) is shown to have a footprint that is sized to be greater than or equal to the area of ​​one of the first helical coil (410) and the second helical coil (412). Figure 5C is a photograph of another exemplary position sensor assembly in which a high magnetic permeability material is disposed between two position sensors. Figure 5D yes Figure 5C Radiograph of the position sensor assembly shown. Similar to Figure 4C , Figure 5C and Figure 5D The high permeability material (450B) shown has a magnetic conductivity that can be less than Figure 5C and Figure 5D The size of the area of ​​one of the first helical coil (410) and the second helical coil (412) is shown as occupying an area.

[0071] Figure 6 is a multivariate graph showing the relationship between the concentration of high permeability material (450) having various magnetic cores compared to magnetic sensors without high permeability material (450). Figure 6 As shown, each panel represents a magnetic sensor (127) with a different concentration of high permeability material (450) attached to the core. The first panel (602) named "Big Mu" represents three test data samples of a magnetic sensor assembly with a high concentration of high permeability material (450) attached. The first panel (602) can represent the use of Figure 5A and Figure 5B 1 shows data collected by a position sensor (127) having a relatively large amount of high magnetic permeability material (450). The second panel (604) entitled "Zero Mu" represents three test data samples of a magnetic sensor assembly having zero concentration of high magnetic permeability material (450) attached. The third panel (606) entitled "Small Mu" represents three test data samples of a magnetic sensor assembly having a low concentration of high magnetic permeability material (450) attached, which can be understood as a concentration of high magnetic permeability material (450) greater than the second panel (604) and less than the first panel (602). The third panel (606) can represent the use of Figure 5C and Figure 5D Data collected by a position sensor (127) is shown with a relatively small amount of high permeability material (450).

[0072] like Figure 6As shown, the magnetic sensitivity of the position sensor (127) with a large amount of high magnetic permeability material (450) has an increased sensitivity compared to the position sensor (127) with no or a small amount of high magnetic permeability material (450). The magnetic sensitivity is expressed in the Y-axis as "change per mil", where "change per mil" is understood to mean the change in magnetic sensitivity per millimeter of high magnetic permeability material (450). In other words, as the amount of high magnetic permeability material (450) increases, the sensitivity of the position sensor (127) also increases.

[0073] Figure 7 is a multivariate graph showing the relationship between magnetic sensitivity, the concentration of high magnetic permeability material (450), and the frequency of the magnetic field. Figure 7 As shown, each panel of the multivariate graph examines the magnetic sensitivity of each magnetic sensor assembly based on the concentration of the high magnetic permeability material (450) at a predetermined frequency. The first panel (702) represents three data sets obtained using three different position sensor (127) assemblies at a first frequency, wherein each corresponding assembly has a high concentration, zero concentration, or a low concentration of the high magnetic permeability material (450). The second panel (704) represents three position sensor (127) assemblies at a second frequency, wherein each assembly has a high concentration, zero concentration, or a low concentration of the high magnetic permeability material (450). The third panel (706) represents three position sensor (127) assemblies at a third frequency, wherein each assembly has a high concentration, zero concentration, or a low concentration of the high magnetic permeability material (450). As shown Figure 7 As shown, the "large Mu" concentration at each frequency produces the highest magnetic sensitivity when compared to the "zero Mu" and "small Mu" concentrations of the high permeability material (450). Figure 7 As shown, a position sensor (127) assembly having a low concentration of high magnetic permeability material (450) has greater sensitivity than a position sensor (127) assembly without any high magnetic permeability material (450).

[0074] Figure 8 is a table showing the magnetic sensitivity of various concentrations of high permeability material (450) for three sample position sensor (127) assemblies. Figure 7 , Figure 8Each panel of provides tabular data representing a position sensor (127) assembly having different concentrations of high magnetic permeability material (450) at a predetermined frequency. The first section (802) shows the magnetic sensitivity of the magnetic sensor (127) having a high magnetic permeability material (450) with zero concentration (which may also be understood as "zero Mu"). The second section (804) shows the magnetic sensitivity of the magnetic sensor (127) having a high concentration (which may also be understood as "large Mu") of the high magnetic permeability material (450). The third section (806) shows the magnetic sensitivity of the magnetic sensor (127) having a low concentration (which may also be understood as "small Mu"). Similar to the magnetic sensitivity that can be obtained from Figure 7 It is concluded that the magnetic sensitivity of the magnetic sensor (127) with "large Mu" is shown to be higher than the magnetic sensitivity of the "small Mu" and "zero Mu" position sensor (127) combination. In other words, increasing the size of the high magnetic permeability material (450) attached to the position sensor (127) can be understood to be proportional to the overall magnetic sensitivity of the position sensor (127).

[0075] like Figure 8 As shown, compared with the position sensor (127) without or with a small amount of high magnetic permeability material (450), it is similar to Figure 5A and Figure 5B The second section (804) of the position sensor (127) assembly shown having a high concentration of high magnetic permeability material (450) has a greater magnetic sensitivity. For example, Figure 8 Each row within the "Change (%)" column of the second section (804) shows a value exceeding 200%, indicating a significant increase in the magnetic sensitivity of the position sensor (127) assembly having a high concentration of high magnetic permeability material (450).

[0076] Compared to a position sensor (127) assembly having no first section (802) of high magnetic permeability material (450), the Figure 5C and Figure 5D Position sensor assemblies similar to those shown in FIG. Figure 8 The third section (806) has a higher magnetic sensitivity. However, Figure 8 The position sensor (127) assembly of the third section (806) has a relatively smaller magnetic sensitivity than the position sensor (127) assembly of the second section (804). For example, Figure 8Each row in the "Change (%)" column for the third section (806) of FIG. 1 is less than each row in the "Change (%)" column for the second section (804), but shows an increase relative to the position sensor (127) without the high magnetic permeability material. In other words, any presence of the high magnetic permeability material (450) attached to the position sensor (127) assembly increases the magnetic sensitivity of the position sensor (127) assembly.

[0077] Fig.9A is a perspective view of an exemplary end effector assembly (900) including an electrode (930) and position sensor (127) assembly. Fig. 9B yes Fig.9A A perspective view of the position sensor (127) assembly shown. Fig.9A As shown, when deployed from the delivery sheath to the open configuration, the end effector assembly (900) may include a generally planar shape. It should be understood that the end effector assembly (900) may be in a closed configuration while compressed within the delivery sheath and then transition to a closed configuration. Fig.9A By having a support structure (910) formed of a plurality of ridges, the end effector assembly (900) can be configured to transition to and maintain the observed geometry when in the open configuration. In some embodiments, the support structure can be formed of Nitinol, which is known in the art to have shape memory properties. One method of shaping the Nitinol can be through a time and temperature heat setting process to ensure that the support structure (910) is configured to maintain a predetermined shape. In other words, as Fig.9A The illustrated Nitinol support structure (910) may be set by a time and temperature heat setting process. However, it should be understood that another suitable elastic material, such as polyetherimide (PEI), etc., may also be a material component of the support structure (910).

[0078] The end effector assembly (900) may further include a polymer (920) that may be disposed across the support structure (910) and may help support the end effector assembly (900). The end effector assembly (900) may further include a plurality of electrodes (930) that may be disposed in one or more rows along the generally planar shape of the end effector assembly (900), such as 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 body of the patient (23). Alternatively or in addition, at least some of the plurality of electrodes (930) may be configured to deliver ablation energy to the tissue.

[0079] 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 also include a first coil (940A), a second coil (940B), and a third coil (940C). In some embodiments, 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 the distal end of the end effector assembly (900), such as Fig. 9B shown.

[0080] Fig. 9C and Fig.9D It is a high magnetic permeability material and Fig.9A and Fig. 9B In some examples, the high magnetic permeability material (950A) may be impregnated into at least a portion of the end effector assembly (900), such as Fig. 9C The impregnated high magnetic permeability material (950A) may be disposed as discrete blocks of high magnetic permeability material (950A) near the first coil (940A), the second coil (940B), and the third coil (940C), as shown. Fig. 9C In some examples, the end effector (900) may include a high magnetic permeability material (950B) printed onto the end effector assembly (900) in a zigzag pattern. The zigzag pattern may begin at the proximal end of the end effector assembly (900) and may span to the distal end of the end effector assembly (900), as shown. Fig.9D shown.

[0081] Fig.10 is a perspective view of another exemplary end effector assembly (1000) in which a high magnetic permeability material has sensor assemblies distributed in an alternating configuration. Fig.10 As shown, the end effector assembly (1000) may have a body with a generally planar shape. In some embodiments, the end effector assembly (1000) may also have a plurality of first electrode assemblies (1030) and a plurality of second electrode assemblies (1040). The plurality of first electrode assemblies (1030) may be disposed along the body of the end effector (1000) and may be configured to detect electrophysiological signals and / or distribute ablation energy to tissue. A second plurality of electrode assemblies (1040) may also be disposed along the body of the end effector assembly (1000), and each of the second plurality of electrode assemblies (1040) may include an electrode (1130), a coil (1140) (as shown in FIG. 11), and a member (950) formed of a high magnetic permeability material (450).

[0082] Each electrode (1130) in the second plurality of electrode assemblies (1040) may be configured to detect electrophysiological signals and / or deliver ablation energy to tissue, as previously mentioned with respect to the plurality of first electrode assemblies (1030). The coil (940) for each electrode assembly in the second plurality of electrode assemblies (1040) may be configured to generate an induced voltage when subjected 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 electrode assembly in the second plurality of electrode assemblies (1040) may be disposed on at least one side of the body of the end effector assembly (900). In some embodiments, the first plurality of electrode assemblies (1030) and the second plurality of electrode assemblies (1040) may be arranged in a horizontal alternating row pattern, such as Fig.10 As shown. It should be understood that the first plurality of electrode assemblies (1030) and the second plurality of electrode assemblies (1040) can also be arranged in alternating rows. In other words, each row can include one electrode assembly from the first plurality of electrode assemblies (1030) across the length (A), followed by one electrode assembly from the second plurality of electrode assemblies (1040), such as Fig.10 It should also be understood that the first plurality of electrode assemblies (1030) and the second plurality of electrode assemblies (1040) can be arranged in a vertical alternating row pattern.

[0083] Fig.11A is a top view of an electrode assembly (1100) having a high magnetic permeability material (1150). Fig. 11B It is along Fig.11A A cross-sectional view taken along line AA of an electrode assembly (1100) with a high magnetic permeability material (1150) is shown. Fig. 11C Is has Fig.11A and Fig. 11B 1. A bottom view of an electrode assembly of a high magnetic permeability material (1150) is shown. 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), wherein the electrode (1130) is disposed on a first side of the planar substrate (1120), such as Fig.11A The electrode assembly (1100) may further include an electromagnetic coil (1140) which may be disposed on the second side of the planar substrate (1120), such as Fig. 11B and Fig. 11C The electromagnetic coil (1140) may be configured to provide a voltage when subjected to a magnetic field and may have a spiral shape having a width approximately equal to the width of the electrode (1130), as shown. Fig. 11Cshown.

[0084] 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 side of the electromagnetic coil (1140) opposite the planar substrate (1120), such as Fig. 11B As shown. Alternatively, a high magnetic permeability member (1150) may also 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 proportional to the resulting magnetic sensitivity of the electromagnetic coil (1140). In other words, a larger high magnetic permeability member (1150) may produce an increased magnetic sensitivity of the electromagnetic coil (1140), which may improve the position sensing performance of the electrode assembly (1100).

[0085] Fig. 12A is a cross-sectional view of an electrode assembly (1200) having a high magnetic permeability material (1250). 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) may include an electrode (1230), a high magnetic permeability material member (1250), and an electromagnetic coil (1240), such as FIG. 12A to FIG. 12C For example, the electrode (1230) may be gold plated, and the high magnetic permeability material member (1250) may be at least partially disposed within the electrode (1230), as shown. Fig. 12A The electrode assembly (1200) may also include a conductive polymer (1260) which may be disposed on top of the electrode (1230), such as Fig. 12B In some embodiments, the conductive polymer (1260) may be formed of a polymer poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS). It should be understood that there are other suitable conductive polymers known in the relevant art that can be utilized with the present technology.

[0086] The electrode assembly (1200) may also include a cover layer of biocompatible adhesive (1270) that may be disposed on top of the electrode (1230) and adjacent to the conductive polymer (1260), such as Fig. 12B The electrode assembly (1200) may also include a substrate (1220) having a generally planar shape, which may be disposed below the electrode (1230), such as Fig. 12B and Fig. 12CIn some embodiments, the 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. Fig. 12C As previously described, the plurality of electromagnetic coils (1240) may have a generally spiral shape, which may have a width approximately equal to the width of the electrode (1230).

[0087] The disclosed technology described herein can be further understood according to the following terms:

[0088] Item 1: A magnetic positioning sensor, comprising: a first spiral coil and a second spiral coil, wherein the first spiral coil and the second spiral coil are arranged on a planar substrate, the first spiral coil and the second spiral coil are arranged around the respective first central axis and the second central axis of the first spiral coil and the second spiral coil, and each of the first spiral coil and the second spiral coil is configured to generate a voltage when subjected to a magnetic field; and a high magnetic permeability planar member, wherein the high magnetic permeability planar member is arranged near one of the first spiral coil and the second spiral coil, so that when the planar coil is wrapped around a cylindrical substrate, the high magnetic permeability planar member is arranged at the intersection of the first central axis and the second central axis.

[0089] Clause 2: The magnetic position sensor of clause 1, wherein the high permeability planar member comprises an area less than or equal to an area of ​​the one of the first and second helical coils.

[0090] Clause 3: The magnetic position sensor of clause 1, wherein the high permeability planar member comprises an area greater than or equal to an area of ​​the one of the first and second helical coils.

[0091] Clause 4: The magnetic position sensor of any of clauses 1 to 3, wherein the high permeability planar member comprises Mu metal.

[0092] Clause 5: The magnetic position sensor of any one of clauses 1 to 3, wherein the high permeability planar member comprises Metglas material.

[0093] Clause 6: A magnetic position sensor according to any of the preceding clauses, wherein the high permeability planar member comprises a high permeability material printed along at least a portion of the planar substrate adjacent the one of the first and second helical coils.

[0094] Clause 7: The magnetic position sensor of clause 6, wherein the high magnetic permeability material is printed in a zigzag pattern along the planar substrate.

[0095] Clause 8: The magnetic position sensor of any of the preceding clauses, further comprising a plurality of discrete high permeability members suspended in a non-conductive material along at least a portion of one of the first and second helical coils.

[0096] Item 9: An electrode assembly, comprising: a planar substrate extending along a plane; an electrode disposed on the planar substrate and configured to detect electrophysiological signals; an electromagnetic coil disposed on the planar substrate and configured to generate a voltage when subjected to a magnetic field; and a component comprising a high magnetic permeability material disposed near the electromagnetic coil.

[0097] Clause 10: The electrode assembly of 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.

[0098] Clause 11: The electrode assembly of clause 10, wherein the member is disposed on a side of the electromagnetic coil opposite the planar substrate.

[0099] Clause 12: The electrode assembly of clause 10, wherein the member is disposed between the electromagnetic coil and the planar substrate.

[0100] Clause 13: The electrode assembly of claim 10, wherein the member is disposed between the electrode and the planar substrate.

[0101] Clause 14: The electrode assembly of any of clauses 9 to 13, wherein the electromagnetic coil comprises a helical shape having a width approximately equal to a width of the electrode.

[0102] Clause 15: The electrode assembly of clause 10, wherein the member is at least partially disposed in the substrate between the electrode and the electromagnetic coil.

[0103] Clause 16: The electrode assembly of clause 10, wherein the member is at least partially disposed in the electrode located on the first side of the substrate.

[0104] Clause 17: An electrode assembly according to any one of clauses 9 to 16, further comprising a conductive polymer material disposed along an outer surface of the electrode.

[0105] Clause 18: The electrode assembly of any of clauses 9 to 17, wherein the high magnetic permeability material comprises Mu metal.

[0106] Clause 19: An electrode assembly as recited in any one of clauses 9 to 17, wherein the high magnetic permeability material comprises Metglas material.

[0107] Clause 20: 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 subjected to a magnetic field; and

[0108] A member is disposed adjacent to the coil and includes a high magnetic permeability material.

[0109] Clause 21: The end effector of clause 21, wherein the end effector comprises a generally planar shape, the plurality of electrodes being arranged in one or more rows along the generally planar shape, and the coil being arranged generally along an outer perimeter of the generally planar shape.

[0110] Clause 22: The end effector of clause 21, 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.

[0111] Clause 23: The end effector of clause 22, wherein the member comprises a high magnetic permeability material printed proximate at least one of the first coil, the second coil, and the third coil along at least a portion of the generally planar shape.

[0112] Clause 24: The end effector of clause 23, wherein the high magnetic permeability material is printed in a zigzag pattern from approximately a proximal end of the generally planar shape to approximately a distal end of the generally planar shape.

[0113] Clause 25: The end effector of any of Clauses 20 to 24, wherein the member further comprises a plurality of discrete members suspended in a non-conductive material along at least a portion of the generally planar shape.

[0114] Clause 26: An end effector according to clause 20, wherein the end effector further comprises a substrate, wherein the plurality of electrodes are disposed on a first side of the substrate, and wherein the coil is disposed on a second side of the substrate proximate at least one of the plurality of electrodes.

[0115] Clause 27: The end effector of clause 26, wherein the member is disposed on a side of the coil opposite the substrate.

[0116] Clause 28: The end effector of clause 26, wherein the member is disposed between the coil and the substrate.

[0117] Clause 29: The end effector of clause 26, wherein the member is disposed between the electrode and the substrate.

[0118] Clause 30: The end effector of any of clauses 26 to 29, wherein the coil comprises a generally helical shape having a width approximately equal to a width of the electrode.

[0119] Clause 31: The end effector of claim 26, wherein the member is at least partially disposed in the substrate between the electrode and the coil.

[0120] Clause 32: The end effector of claim 26, wherein the member is at least partially disposed in the electrode located on the first side of the substrate.

[0121] Clause 33: The end effector of any of Clauses 26 to 32, further comprising a conductive polymer material disposed along an outer surface of the electrode.

[0122] Clause 34: The end effector of any one of clauses 20 to 33, wherein the high magnetic permeability material comprises Mu metal.

[0123] Clause 35: The end effector of any one of clauses 20 to 33, wherein the high magnetic permeability material comprises Metglas material.

[0124] Clause 36: The end effector of any one of clauses 20 to 35, further comprising an insulating substrate disposed between the plurality of electrodes and the coil.

[0125] Clause 37: The end effector of any one of clauses 20 to 36, further comprising an insulating material disposed between the plurality of electrodes and the member.

[0126] Item 38: An end actuator, comprising: a body having a generally planar shape; a plurality of first electrode assemblies disposed along the body and configured to detect electrophysiological signals; a plurality of second electrode assemblies disposed along the body, each of the plurality of second electrode assemblies comprising: an electrode configured to detect electrophysiological signals; a coil disposed on the body and configured to generate a voltage when subjected to a magnetic field; and a component comprising a high magnetic permeability material disposed on at least one side of the body.

[0127] Clause 39: The end effector of clause 38, wherein the plurality of first electrode assemblies and the plurality of second electrode assemblies are disposed in an alternating pattern along the body.

[0128] Clause 40: The end effector of clause 38 or 39, wherein the plurality of first electrode assemblies and the plurality of second electrode assemblies are disposed in an alternating pattern on the first side of the body and on the second side of the body.

[0129] Clause 41: The end effector of any of Clauses 38 to 40, wherein the alternating pattern comprises a plurality of first electrode assemblies arranged in a first row and a plurality of second electrode assemblies arranged in a second row.

[0130] Clause 42: The end effector of any one of clauses 38 to 40, wherein each electrode assembly of the plurality of second electrode assemblies comprises: the electrode disposed on a first side of a substrate; and the coil disposed on a second side of the substrate.

[0131] Clause 43: The end effector of clause 42, wherein the member is disposed on a side of the coil opposite the substrate.

[0132] Clause 44: The end effector of clause 42, wherein the member is disposed between the coil and the substrate.

[0133] Clause 45: The end effector of clause 42, wherein the member is disposed between the electrode and the substrate.

[0134] Clause 46: The end effector of any of Clauses 42 to 45, wherein the coil comprises a helical shape having a width approximately equal to a width of the electrode.

[0135] Clause 47: The end effector of clause 42, wherein the member is at least partially disposed in the substrate between the electrode and the coil.

[0136] Clause 48: The end effector of clause 42, wherein the member is at least partially disposed in the electrode located on the first side of the substrate.

[0137] Clause 49: The end effector of any of Clauses 42 to 48, further comprising a conductive polymer material disposed along an outer surface of the electrode.

[0138] Clause 50: The end effector of any one of clauses 38 to 49, wherein the high magnetic permeability material comprises Mu metal.

[0139] Item 51: An end actuator, comprising: a plurality of flexible ridges configured to transition the end actuator between an expanded configuration and a collapsed configuration; a plurality of electrode assemblies disposed along the plurality of flexible ridges, each of the plurality of electrode assemblies comprising: a substrate extending at least partially along a ridge among the plurality of flexible ridges; 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 subjected to a magnetic field; and a component comprising a high magnetic permeability material.

[0140] Clause 52: The end effector of clause 51, wherein the member is disposed on a side of the coil opposite the substrate.

[0141] Clause 53: The end effector of clause 51, wherein the member is disposed between the coil and the substrate.

[0142] Clause 54: The end effector of clause 51, wherein the member is disposed between the electrode and the substrate.

[0143] Clause 55: The end effector of any of Clauses 51 to 54, wherein the coil comprises a generally helical shape having a width approximately equal to a width of the electrode.

[0144] Clause 56: The end effector of clause 51, wherein the member is at least partially disposed in the substrate between the electrode and the coil.

[0145] Clause 57: The end effector of clause 51, wherein the member is at least partially disposed in the electrode located on the first side of the substrate.

[0146] Clause 58: The end effector of any of Clauses 51 to 57, further comprising a conductive polymer material disposed along an outer surface of the electrode.

[0147] Clause 59: The end effector of any one of clauses 51 to 58, wherein the high magnetic permeability material comprises Mu metal.

[0148] Clause 60: The end effector of any one of clauses 51 to 58, wherein the high magnetic permeability material comprises Metglas material.

[0149] Any example or embodiment described herein may also include various other features in addition to or as an alternative to those described above. The teachings, expressions, embodiments, examples, etc. described herein should not be considered independent of each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art with reference to the teachings herein.

[0150] Exemplary embodiments of the subject matter contained herein have been shown and described, and further improvements of the methods and systems described herein may be achieved by appropriate modifications without departing from the scope of the claims. In addition, where the above methods and steps represent specific events that occur in a specific order, it is intended that certain specific steps do not necessarily have to be performed in the order described, but can be performed in any order, as long as the steps enable the implementation to achieve its intended purpose. Therefore, if there are variations of the present invention and these variations belong to the substantial scope of the disclosure of the present invention or equivalents that can be found in the claims, this patent is intended to also cover these variations. Many such modifications will be obvious to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. described above are all exemplary. Therefore, the claims should not be limited to the specific details of the structure and operation shown in this written description and the drawings.

Claims

1. A magnetic positioning sensor, comprising: a first helical coil and a second helical coil, the first helical coil and the second helical coil being disposed on a planar substrate, the first helical coil and the second helical coil being disposed about respective first and second central axes of the first and second helical coils, and each of the first and second helical coils being configured to generate a voltage when subjected to a magnetic field; and A high magnetic permeability planar member is disposed near one of the first spiral coil and the second spiral coil, so that when the planar coil is wrapped around the cylindrical substrate, the high magnetic permeability planar member is disposed at the intersection of the first central axis and the second central axis.

2. The magnetic positioning sensor according to claim 1, wherein: The high magnetic permeability planar member includes an area that is less than or equal to an area of ​​the one of the first and second helical coils.

3. The magnetic positioning sensor according to claim 1, wherein: The high magnetic permeability planar member includes an area greater than or equal to an area of ​​the one of the first and second helical coils.

4. The magnetic positioning sensor according to claim 1, wherein: The high magnetic permeability planar member includes Mu metal.

5. The magnetic positioning sensor according to claim 1, wherein: The high magnetic permeability planar member comprises Metglas material.

6. The magnetic positioning sensor according to claim 1, wherein: The high permeability planar member includes a high permeability material printed along at least a portion of the planar substrate adjacent the one of the first and second helical coils.

7. The magnetic positioning sensor according to claim 6, wherein: The high magnetic permeability material is printed in a zigzag pattern along the planar substrate.

8. The magnetic positioning sensor according to claim 1, wherein: The magnetic position sensor also includes a plurality of discrete high magnetic permeability members suspended in a non-conductive material along at least a portion of one of the first helical coil and the second helical 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 subjected to a magnetic field; and A component includes a high magnetic permeability material, and the high magnetic permeability material is disposed near the electromagnetic coil.

10. The electrode assembly according to 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 according to claim 10, wherein The member is disposed on a side of the electromagnetic coil opposite to the planar substrate.

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

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

14. The electrode assembly according to claim 9, wherein The electromagnetic coil includes a helical 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 subjected to a magnetic field; and A member is disposed adjacent to the coil and includes a high magnetic permeability material.

16. The end effector of claim 15, comprising a generally planar shape, the plurality of electrodes being arranged in one or more rows along the generally planar shape, and the coil being arranged generally along an outer perimeter of the generally planar shape.

17. The end effector according to claim 16, wherein: The coil also includes 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 proximate 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 adjacent to at least one of the first coil, the second coil, and the third coil.

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

20. The end effector of claim 15, wherein: The member also includes a plurality of discrete members suspended in the non-conductive material along at least a portion of the generally planar shape.

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