Planar catheter having a sensing loop and electrodes on the same flexible circuit

Abstract

To provide medical probes suitable for use in tissue mapping and ablation. [Solution] The technology of the present disclosure includes a flexible circuit for an end effector of a medical probe. The flexible circuit includes a flexible substrate, electrodes, and a first sensing loop. The flexible substrate defines tines extending along a longitudinal axis. Electrodes are positioned on each of the tines. The first sensing loop is positioned on the flexible substrate. The first sensing loop forms one or more coils configured to generate an electric current, which indicates the position of one or more coils when one or more coils are exposed to a magnetic field. The first sensing loop includes two segments positioned on each tine, extending substantially parallel to the longitudinal axis and converging toward each other on the tines positioned on the longitudinal axis.

Description

Technical Field

[0001] This technology generally relates to medical devices, particularly medical probes having electrodes, and more particularly to medical probes suitable for use in tissue mapping and ablation, but is not limited thereto.

Background Art

[0002] Cardiac arrhythmias such as atrial fibrillation occur when electrical signals abnormally conduct from a region of cardiac tissue to adjacent tissue, thereby disrupting the normal cardiac cycle and causing asynchronous rhythms. The undesired signal source may be located in atrial or ventricular tissue. The unwanted signals may conduct through the cardiac tissue to other locations, causing or continuing an arrhythmia.

[0003] Treatments for treating arrhythmias include surgically interfering with the source of the signals causing the arrhythmia and interfering with the conduction paths of such signals. More recently, it has been found that by mapping the electrical properties and cardiac volume of the endocardium and selectively ablating cardiac tissue by applying energy, it is possible to interrupt or modify the propagation of unwanted electrical signals from one part of the heart to another. The ablation process breaks the unwanted electrical pathways by forming non-conductive lesions.

[0004] In this two-step procedure, including mapping and subsequent ablation, a catheter equipped with one or more electrical sensors is typically advanced into the heart, and data is acquired at numerous points so that the electrical activity at each point within the heart is sensed and measured. Then, these data are used to select the target area where ablation is to be performed.

[0005] For higher mapping resolution, it is desirable that the mapping catheter closely conforms to the target anatomical structure. For mapping within the atria or ventricles (e.g., the apex of the ventricle), it is desirable that the catheter collects more data signals in a shorter time. Furthermore, such catheters should allow sufficient electrode contact with various tissue surfaces, e.g., flat, curved, irregular, or non-planar surface tissues, and should be foldable for non-invasive advancement and retreat through the patient's vascular system. Existing catheters generally require rigid internal structural members to ensure that the predetermined configuration is maintained. This rigidity is disadvantageous during manipulation within body organs, as it can hinder electrode contact with tissue.

[0006] Other catheters may include flexible end-effectors designed to overcome this disadvantage. These catheters may contain layered components that are time-consuming, complex, and expensive to manufacture and assemble. Furthermore, electrical traces and other associated components may be prone to breakage and / or detachment during use. [Overview of the project] [Means for solving the problem]

[0007] The present disclosure provides a flexible circuit for an end effector of a medical probe. The flexible circuit comprises a flexible substrate defining a plurality of tines extending along a longitudinal axis, a plurality of electrodes positioned on each of the plurality of tines, and a first sensing loop positioned on the flexible substrate. The first sensing loop forms one or more coils configured to generate a current, the current indicating the position of one or more coils when one or more coils are exposed to a magnetic field. The first sensing loop comprises two segments positioned on each of the plurality of tines extending substantially parallel to the longitudinal axis and converging toward each other on the tines positioned on the longitudinal axis of the plurality of tines.

[0008] The present disclosure further provides a flexible circuit for an end effector of a medical probe. The flexible circuit comprises a flexible substrate defining a plurality of tines extending along a longitudinal axis, a plurality of electrodes disposed on each of the plurality of tines, and a first sensing loop and a second sensing loop disposed on the flexible substrate. Each of the first sensing loop and the second sensing loop forms one or more coils configured to generate a current, the current indicating the position of one or more coils when one or more coils are exposed to a magnetic field. The first sensing loop comprises two segments disposed on each of the plurality of tines extending along a longitudinal axis and converging toward each other on a tine offset from the longitudinal axis among the plurality of tines. The second sensing loop comprises two segments disposed on each of the plurality of tines extending along a longitudinal axis and converging toward each other on another tine offset from the longitudinal axis among the plurality of tines.

[0009] Further, the technology of the present disclosure provides an end effector for a medical probe. The end effector comprises an insulating material, a framework disposed within the insulating material and substantially planar along the longitudinal axis, and a first flexible circuit disposed within the insulating material so as to be spaced apart from the framework along the vertical axis. The first flexible circuit comprises a first flexible substrate defining a first plurality of tines extending along the longitudinal axis, a first plurality of electrodes disposed on each of the first plurality of tines, and a first sensing loop and a second sensing loop disposed on the first flexible substrate. Each of the first sensing loop and the second sensing loop forms one or more coils configured to generate a current, the current indicating the position of one or more coils when one or more coils are exposed to a magnetic field. The first sensing loop comprises two segments disposed on each of the first plurality of tines extending along the longitudinal axis and converging toward each other on tines of the first plurality of tines offset from the longitudinal axis. The second sensing loop comprises two segments positioned on each of the first plurality of tines extending along the longitudinal axis, and converging toward each other on another tine of the first plurality of tines offset from the longitudinal axis.

[0010] The present disclosure further provides a method for forming a plurality of electrodes on a first surface of a plurality of tines of a flexible circuit, wherein the plurality of tines extend substantially parallel to a longitudinal axis, and for forming a position-sensing loop on the first surface. The position-sensing loop forms one or more coils configured to generate an electric current, the current indicating the position of one or more coils when one or more coils are exposed to a magnetic field. The position-sensing loop comprises two segments that (i) extend along each of the plurality of tines and (ii) converge toward each other on one of the plurality of tines, either positioned on the longitudinal axis or offset from the longitudinal axis.

[0011] Further, the present disclosure provides an end effector for a medical probe. The end effector comprises an insulating material, a framework disposed within the insulating material and substantially planar along the longitudinal axis, and a first flexible circuit disposed within or on the insulating material. The first flexible circuit comprises a first flexible substrate defining a first plurality of tines extending along the longitudinal axis, a first plurality of electrodes disposed on each of the first plurality of tines, and a first sensing loop and a second sensing loop disposed on the first flexible substrate. Each of the first sensing loop and the second sensing loop forms one or more coils configured to generate a current, the current indicating the position of one or more coils when one or more coils are exposed to a magnetic field. The first sensing loop comprises two segments disposed on each of the first plurality of tines extending along the longitudinal axis and converging toward each other on tines of the first plurality of tines offset from the longitudinal axis. The second sensing loop comprises two segments positioned on each of the first plurality of tines extending along the longitudinal axis, and converging toward each other on another tine of the first plurality of tines offset from the longitudinal axis. [Brief explanation of the drawing]

[0012] [Figure 1] This is a schematic diagram of a medical system including a medical device, including a medical probe having an end effector equipped with electrodes, based on the disclosed technology. [Figure 2A] This is a schematic diagram showing an exploded perspective view of an exemplary end effector using the technology of the present disclosure. [Figure 2B] This is a schematic diagram showing a cross-sectional view of an assembled end effector along line L1 in Figure 2A, according to the technology of this disclosure. [Figure 2C] This schematic diagram shows a cross-sectional view similar to that of Figure 2B, with a modified configuration of an assembled end effector according to the technology of the present disclosure. [Figure 2D]This schematic diagram shows a cross-sectional view similar to that of Figure 2B, with a modified configuration of an assembled end effector according to the technology of the present disclosure. [Figure 3A] This is a schematic drawing showing a plan view of a portion of the first flexible circuit of an end effector according to the technology of the present disclosure. [Figure 3B] This is a schematic diagram showing a cross-sectional view of a tine of a first flexible circuit along line 3B-3B in Figure 3A, according to the technology of the present disclosure. [Figure 4] This is a schematic drawing showing a plan view of a first flexible circuit according to the technology of this disclosure. [Figure 5] This is a schematic drawing showing a plan view of the second flexible circuit of an end effector according to the technology of the present disclosure. [Figure 6] These are schematic diagrams showing the general layout of the locations where the detailed drawings in Figures 6A to 6E were taken. [Figure 6A] This is a schematic diagram showing a detailed view of the proximal portion of the first flexible circuit according to the technology of this disclosure. [Figure 6B] This is a schematic diagram showing a detailed view of the intermediate lateral portion of the first flexible circuit according to the technology of this disclosure. [Figure 6C] This is a schematic diagram showing a detailed view of the distal lateral portion of the first flexible circuit according to the technology of this disclosure. [Figure 6D] This is a schematic diagram showing a detailed view of the distal central portion of a first flexible circuit according to the technology of this disclosure. [Figure 6E] This is a schematic diagram showing a detailed view of the proximal central portion of a first flexible circuit according to the technology of this disclosure. [Figure 7] This is a schematic diagram showing a detailed view of an alternative first flexible circuit using the technology of the present disclosure. [Figure 8] This is a schematic diagram showing a medical probe assembly based on the technology of this disclosure. [Figure 9] This is a flowchart of the manufacturing method using the technology disclosed herein. [Modes for carrying out the invention]

[0013] The following detailed description is to be read with reference to the drawings, and like elements in different drawings are numbered the same. The drawings are not necessarily to scale, depict selected embodiments, and are not intended to limit the scope of the invention. The detailed description is illustrative, not limiting, and is given by way of example to illustrate the principles of the invention. This specification describes some embodiments, adaptations, variations, alternatives, and uses of the invention, including what is presently considered to be the best mode for carrying out the invention, to enable those skilled in the art to make and use the invention.

[0014] As used herein, the terms "about" or "substantially" or "generally" with respect to any numerical value or range indicate a suitable dimensional tolerance that allows a component or collection of components to function for the intended purpose described herein. More specifically, "about" or "substantially" or "generally" can refer to a range of values that are ±20% of the recited value. For example, "about 90%" can refer to a range of values from 71% to 110%. As a further example, "substantially parallel" can refer to a range of values of parallel (i.e., 0 degrees relative to each other) ±20 degrees. In addition, as used herein, the terms "patient", "host", "user", and "subject" refer to any human or animal subject, and the use of the subject technology in a human patient represents a preferred embodiment, but is not intended to limit the system or method to human use. Similarly, the term "proximal" indicates the position closer to the operator or physician, while "distal" indicates the position farther from the operator or physician.

[0015] As discussed herein, the vasculature of a "patient", "host", "user", and "subject" can be that of a human or any animal. It should be understood that the animal can 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 can be an experimental animal (e.g., rat, dog, pig, monkey, etc.) specifically selected to have certain properties similar to those of a human. It should be understood that the subject can be, for example, any applicable human patient.

[0016] As discussed herein, an "operator" can include a physician, surgeon, technician, scientist, or any other individual or delivery device associated with the delivery of a multi-electrode catheter for the treatment of drug refractory atrial fibrillation to a subject.

[0017] The present disclosure relates to systems, methods, uses, and devices for mapping and ablation of cardiac tissue for treating cardiac arrhythmias. Ablation energy is typically delivered to the cardiac tissue by a tip portion of a catheter capable of delivering ablation energy along the tissue to be ablated. Some exemplary catheters include a three-dimensional structure at the tip portion and are configured to manage ablation energy from various electrodes positioned on the three-dimensional structure. Ablation procedures incorporating such exemplary catheters can be visualized using fluoroscopy.

[0018] Cardiac tissue ablation, which involves applying radiofrequency (RF) energy and thermal techniques such as cryoablation, is a well-known procedure for improving a dysfunctional heart. Typically, to successfully ablate using thermal techniques, it is necessary to measure electrocardiograms at various locations in the myocardium. In addition, temperature measurements during ablation provide data that enables the effectiveness of the ablation. Usually, in ablation procedures using thermal techniques, electrode potentials and temperature are measured before, during, and after the actual ablation. RF approaches can carry risks that can lead to tissue carbonization, combustion, steam popping, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistula. Cryoablation is an alternative approach to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, operating cryoablation equipment and selectively applying cryoablation is generally more difficult than RF ablation. Therefore, cryoablation is not feasible in certain anatomical shapes that can be reached by electroablation equipment.

[0019] This disclosure may include electrodes configured for RF ablation, cryoablation, and / or irreversible electroporation (IRE). Throughout this disclosure, IRE may be interchangeably referred to as pulsed field (PEF) ablation and pulsed field ablation (PFA). The IRE considered in this disclosure is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. To ablate using IRE / PEF, a biphasic voltage pulse is applied to destroy the cellular structure of the myocardium. The biphasic pulse is a non-sinusoidal waveform and can be tailored to the target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat in the treatment area, indiscriminately heating all cells within the treatment area. Thus, IRE has the ability to save adjacent heat-sensitive structures or tissues, which would be beneficial in reducing the potential complications known in ablation or isolation modalities. Additionally or alternatively, monophasic pulses can be utilized.

[0020] Refer to Figure 1, which shows an exemplary catheter-based electrophysiological mapping and ablation system 10. The system 10 includes multiple catheters that are percutaneously inserted by a physician 24 into a lumen or vascular structure of the heart 12 through the vascular system of the patient 23. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location in the heart 12. Multiple catheters can then be inserted into the delivery sheath catheter to reach the desired location. The multiple catheters may include a catheter dedicated to sensing intracardiac electrophysiological (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An exemplary catheter / medical probe 14 configured to sense IEGM is illustrated herein. To sense a target site in the heart 12, the physician 24 brings the catheter shaft having the distal end 28 (e.g., multilayer end effector 100) of the catheter 14 into contact with the heart wall. For ablation, the physician 24 similarly brings the distal end of an ablation catheter to the target site for ablation.

[0021] Catheter 14 is an exemplary catheter comprising one, preferably multiple, electrodes 102 optionally distributed across a distal end 28 connected to a catheter shaft and configured to sense IEGM signals, as will be described in more detail below. Catheter 14 may additionally include a position sensor embedded in or near the distal end 28 to track the position and orientation of the distal end 28. Optionally and preferably, the position sensor is a magnetic-based position sensor comprising multiple magnetic coils for sensing three-dimensional (3D) position and orientation.

[0022] A magnetic-based position sensor may operate in conjunction with a position pad 25 which includes a plurality of magnetic coils 32 configured to generate a magnetic field within a given working volume. The real-time position of the end effector 100 of the catheter 14 may be tracked based on the magnetic field generated by the position pad 25 and sensed by the magnetic-based position sensor. Details of magnetic-based position sensing technology are described in U.S. Patents No. 5,391,199, No. 5,443,489, No. 5,558,091, No. 6,172,499, No. 6,239,724, No. 6,332,089, No. 6,484,118, No. 6,618,612, No. 6,690,963, No. 6,788,967, and No. 6,892,091, each of which is incorporated herein by reference.

[0023] System 10 includes one or more electrode patches 38 positioned for skin contact on a patient 23 to establish a position reference for the position pad 25 and impedance-based tracking of the electrodes 102. For impedance-based tracking, a current is directed to the electrodes 102 and sensed in the electrode skin patches 38, thereby allowing the position of each electrode to be triangulated through the electrode patches 38. Details of the impedance-based location tracking technology 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.

[0024] The recorder 11 displays the electrophysiogram 21 captured by the surface ECG electrode 18 and the intracardiac electrophysiogram (IEGM) captured by the electrode 102 of the catheter 14. The recorder 11 may include pacing capabilities for pacing the rhythm of the heart and / or may be electrically connected to a standalone pacer.

[0025] System 10 may include an ablation energy generator 50 adapted to deliver ablation energy to one or more electrodes 160A, 160B located on the end effector 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, pulsed-field ablation (PFA) energy including unipolar or bipolar high-voltage DC pulses that may be used to perform irreversible electroporation (IRE), or a combination thereof.

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

[0027] The workstation 55 includes memory, a processor unit having memory or storage device loaded with appropriate operating software, and user interface functions. The workstation 55 may optionally provide several functions, including (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering the model or anatomical map 20 for display on a display device 27, (2) displaying activation sequences (or other data) compiled from recorded electrophoresis diagrams 21 on the display device 27 as a representative visual representation or image superimposed on the rendered anatomical map 20, (3) displaying the real-time position and orientation of multiple catheters within the cardiac chambers, and (4) displaying areas of interest on the display device 27, such as the location where ablation energy is being applied. One commercially available product embodying the 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.

[0028] Figures 2A to 6E provide various view diagrams of one or more parts of the end effector 100 (in this specification, the term “end effector” is used synonymously with the term “distal tip”) configured for insertion into the internal body cavity of a patient. Specifically, Figure 2A shows an exploded view of the first end effector 100, and its components (note that certain components, such as loop 146, are shown for illustrative purposes and are not necessarily located in the side / region shown in Figure 2A) extend along the longitudinal axis 60 and are exploded vertically along the vertical axis 62 (perpendicular to the longitudinal axis 60); Figure 3A shows a portion of the flexible circuit 150 of the end effector 100; Figure 3B shows a cross-sectional view of the flexible circuit 150 cut along line 3B-3B in Figure 3A; Figure 4 shows the flexible circuit 150 including one or more position-sensing loops 140; Figure 5 shows a diagram of another opposing flexible circuit 110 of the end effector 100; and Figures 6A to 6E are detailed diagrams of the flexible circuit 150. The opposing flexible circuit 110 is designed identically in this example, except for the configuration of the position sensing loop 140. Therefore, any description of the first flexible circuit 150 accurately describes the configuration of the second flexible circuit 110, unless otherwise stated.

[0029] The end effector 100 extends from a proximal end (upper right in Figure 2A) connected to an elongated shaft 230 (Figure 8, also called a tubular member) to a distal end (lower left in Figure 2A) along the longitudinal axis 60, and includes components that are continuous with and / or located within the insulating material 130. For example, the end effector 100 may include a first flexible circuit 150 and a second flexible circuit 110. The first flexible circuit 150 (and the second flexible circuit 110) includes a plurality of electrodes 160. In some embodiments, the term “flexible circuit” includes thin-film circuits, flexible printed circuit boards, and thin-film deposition by lithography and etching processes on substrates such as polyimide, copper, LCP, nitinol substrates, thermoplastic polyurethane (TPU), silicone, thermosetting resins, or other polymer substrates. In some embodiments, the flexible circuit layers described herein can be made primarily from polyimide. In other embodiments, it can be fabricated using biocompatible polyimide, glass-reinforced epoxy laminate, copper, or graphene, either alone or in combination. In some examples, the electrode 160A described herein may include at least one mapping electrode and / or at least one ablation electrode, which may be configured to detect an electrophysiological signal or to transmit ablation energy AC or DC from an energy generator to the tissue according to various ablation methods mentioned above, e.g., RF, IRE, etc. The structure of the first flexible circuit 110 (and similarly, the second flexible circuit 150) will be discussed in more detail with respect to Figures 3A to 6E below.

[0030] The second end effector 100 may further include a framework 120 that is continuous with or located within the insulating material 130. In examples where the distal tip 28 includes the framework 120, the framework 120 may be located directly on the first flexible circuit 150 (or both the first flexible circuit 150 and the second flexible circuit 110), with little or no insulating material 130 located between them. In other embodiments, the insulating layer of the insulating material 130 may separate the framework 120 from the flexible circuits 110, 150. In some examples, the framework 120 is located within the insulating material 130 and is substantially planar along the longitudinal axis 60, such that the longitudinal axis 60 is parallel to or coincides with the framework 120. In some examples, the framework 120 is symmetrical with respect to the longitudinal axis 60. In some examples, the framework 120 is formed from a flexible elastic material. For example, the framework can be formed from shape memory alloys such as nickel-titanium, cobalt-chromium, stainless steel, and / or other alloys exhibiting pseudo-elastic and / or superelastic properties, also known as nitinol. The framework 120 can be formed from a planar or cylindrical stock of material using any preferred method. For example, the framework 120 can be formed by cutting, laser cutting, stamping, etc.

[0031] As described above, the flexible circuits 110 and 150 are positioned in or on the insulating material 130 extending along the longitudinal axis 60. More specifically, the flexible circuits 110 and 150 can have any number of positional relationships with the insulating material 130 without departing from the spirit and scope of this disclosure. Figures 2B to 2D are exemplary alternative cross-sectional views along line L1 in Figure 2A when the end effector 100 is assembled, illustrating some of these potential positional relationships. These different positional relationships can provide various advantages, such as improved mechanical properties, manufacturability, and / or sensing properties, depending on the selected design.

[0032] As a non-limiting example, one or both of the flexible circuits 110, 150 may (1) be placed on the outer surfaces 131A, 131B of the insulating material 130 (for example, as shown in Figure 2C), (2) be suspended within the insulating material 130 and placed substantially flat (for example, as shown in Figure 2B or Figure 2D), or (3) be suspended on and / or within the insulating material 130 at various distances from the framework 120 (for example, one or more parts of the flexible circuits 110, 150 may be placed at a certain height relative to the framework 120 (relative to the vertical axis 62), and the other parts of the flexible circuits 110, 150 may be placed at different heights relative to the framework 120 (relative to the vertical axis)).

[0033] In other words, with respect to the third example mentioned in the previous paragraph, the flexible circuits 110, 150 do not necessarily have to be placed in a plane that is flat and / or parallel to the plane of the framework 120 (i.e., they may be non-parallel to the framework 120). For example, some parts of the flexible circuits 110, 150 may be closer to the outer surfaces 131A, 131B of the insulating material 130 (e.g., parts of the flexible circuits 110, 150 that are further from the framework 120, as depicted in Figure 2B), while other parts may be closer to the framework 120 (e.g., parts of the flexible circuits 110, 150 that are closer to the framework, as depicted in Figure 2D).

[0034] The insulating material 130 can be continuous with the contact surfaces such that only the contact surfaces of at least some of the electrodes 160 are exposed to the ambient environment. As used herein, “ambient environment” refers to the external environment, such as an operating room, before the organ in which the first end effector 100 is placed or placed within a biological organ. The insulating material 130 at least partially encapsulates and / or separates different layers of the end effector 100 (e.g., flexible circuits 110, 150 and framework 120) along the vertical axis 62.

[0035] It should be noted that all electrodes 160 on the flexible circuits 110, 150 described herein do not need to be exposed through the insulating material 130, as these unexposed electrodes may be used to sense far-field signals for noise reduction in proximity to the tissue contact electrodes. Similarly, far-field signals containing noise or artifacts can be reduced or canceled out against the entire end effector, which has a reference electrode that does not come into contact with tissue and only with blood.

[0036] The insulating material 130 may include one or more sheets that are fused together in close proximity to the framework 120 to form a single, continuous, generally planar insulating mass 130. This insulating material 130 also works to enhance the non-traumaticity of the end effector tip 100 and to protect the object from sharp edges. The insulating material 130 may include a polymer. The insulating material 130 can be thermoformed around the first flexible circuit 150, the second flexible circuit 110, and at least a portion of the framework 120. The polymer may include TPU or other thermoforming or shaping materials suitable for such thermoforming.

[0037] Furthermore, although the insulating material 130 is shown as flat in these figures, the insulating material 130 may be shaped, corrugated, undulating, raised, concave, convex, or otherwise configured such that the overall shape of the insulating material 130 provides physical and / or mechanical properties such as rigidity and flexibility along multiple axes required by the distal tip portion 28 / end effector 100 mentioned above.

[0038] The flexible substrates of each flexible circuit 110, 150 (for example, flexible substrate 150-1 shown in Figure 3B) contain a biocompatible material and have a first side and a second side. In some examples, the flexible substrates are formed entirely or almost entirely from a biocompatible material. The electrodes 160 are positioned on the surface of the flexible substrate, such as the first surface 150A of the first flexible circuit 150. In some examples, the electrodes 160 are positioned on only one side of the substrate 150-1, and the electrical interconnects / traces 162 connected to the electrodes and supplying power are routed on the opposite surface 150B of the flexible circuit 150. See, for example, Figure 3B, and the dashed lines in Figure 3A showing an exemplary electrical trace 162. In other words, the electrodes 160 are oriented away from the framework 120, and the electrical traces 162 are oriented toward the framework 120.

[0039] Referring particularly to Figures 4 and 5, each flexible circuit 110, 150 includes a base 111, 151 with a plurality of electrodes 160 and solder pad areas located at their proximal ends (the bottoms in Figures 5 and 4, respectively), a plurality of tines 112-116, 152-156 extending from the base 111, 151, a plurality of gaps 119A-H, 159A-H defined between the tines 112-116, 152-156, and connecting distal segments 118, 158.

[0040] Referring particularly to Figure 4, the first flexible circuit 150 includes a flexible substrate 150-1, a central tine 154 extending along the longitudinal axis 60, and offset tines 152, 153, 155, and 156 offset from the longitudinal axis. More specifically, the offset tines 152, 153, 155, and 156 extend away from the longitudinal axis 60, and then roughly along / parallel to it, from the base 151. Multiple electrodes 160 are arranged on each tine 152-156. The electrodes 160 can be arranged along the tines 152-156 so as to be aligned with electrodes 160 on adjacent tines 152-156 along the longitudinal axis 60. In other examples, the electrodes 160 do not have to be aligned with respect to electrodes 160 on adjacent tines in the direction across the longitudinal axis 60, but rather they may be staggered (i.e., alternating) so that they are arranged in a pattern of alternating alignment from tine to tine.

[0041] The tines 152-156 include a first tine 152 extending from the base 151 along the longitudinal axis 60, a second tine 153 extending from the base 151 along the longitudinal axis 60, a third tine 154 extending from the base 151 along the longitudinal axis 60, a fourth tine 155 extending from the base 151 along the longitudinal axis 60, and a fifth tine 156 extending from the base 151 along the longitudinal axis 60. As can be seen in Figure 4, the first to fifth tines 152-156 are arranged continuously from left to right. The first flexible circuit further includes a first intermediate connection segment 157A connecting the second tine 153 and the third tine 154, a second intermediate connection segment 157B connecting the third tine 154 and the fourth tine 155 toward the distal end of the flexible circuit 150, and a connecting distal segment 158 ​​connecting the distal ends of the first tine 152, the second tine 153, the third tine 154, the fourth tine 155, and the fifth tine 156.

[0042] The tines 152-156, connecting segments 157A, 157B, and connecting distal segment 158 ​​collectively define the respective gaps 159A-H between them. Specifically, the gaps 159A-H (i.e., areas not covered by any material) are defined between the respective tines 152-156 of the flexible circuit 150. This reduction in material can help facilitate folding the end effector 100 into the sheath and / or insertion tool.

[0043] Furthermore, the tine includes connecting outer segments 152A, 156A that do not include the electrode 160. Rather, these segments help define the shape of the end effector 100 and provide reinforcement / protection to the segments of the flexible circuit 150 that carry the electrical trace 162 and / or electrode 160.

[0044] Continuing to refer to Figures 2 to 4 and Figures 6A to 6E, multiple sensing loops 140 can be provided on the flexible substrate 150-1 of the first flexible circuit 150. Specifically, as illustrated in Figure 3B, the electrodes 160 and the position sensing loops 140 (see coil 142 of the position sensing loop 140) are arranged on the same first surface 150A of the flexible substrate 150-1.

[0045] Each sensing loop 140 functions as a position sensor having one or more coils (each coil corresponding to a single turn of its respective position sensing loop) that, when exposed to a magnetic field, each induce a trace of current indicating the position and / or shape of the end effector 100 (thus referred to herein as a position sensing loop, but note that the loops may have more functions than providing position information). Each coil includes a surface area defined by the area enclosed by its respective coil, corresponding to a specific region of the flexible circuits 110, 150. By providing multiple coils within the sensing loop 140, the total surface area covered by the loop 140 can be increased. Furthermore, by placing the sensing loop 140 on the same layer as the electrodes 160 of the end effector 100, the electrode traces 162 can be shifted closer to the neutral plane of the end effector 100 (compared to end effectors where the sensing loop 140 requires its own flexible circuit layer), which minimizes distortion on these traces 162 and reduces the complexity of the end effector 100.

[0046] In the example of the first flexible circuit 150, there are a first position sensing loop 140A and a second position sensing loop 140B. Each of the first position sensing loop 140A and the second position sensing loop 140B includes one or more coils 142. The first position sensing loop 140A generally extends along a base 151, a first tine 152, a connecting distal segment 158, a second tine 153, a first intermediate connecting segment 157A, and a third tine 154. The second position sensing loop 140B generally extends along a base 151, a fifth tine 156, a connecting distal segment 158, a fourth tine 155, a second intermediate connecting segment 157B, and a third tine 154.

[0047] As shown in Figure 4, the first position sensing loop 140A is generally divided into a first segment 140A-1 and a second segment 140A-2. The first segment 140A-1 is routed along the first tine 152 and the lateral portion of the distal connection segment 158, and the second segment 140A-2 is routed along the third tine 154 and the first intermediate connection segment 157A. These segments 140A-1 and 140A-2 converge together on the distal portion 151A of the base 151 and on the second tine 153 (offset from the longitudinal axis 60).

[0048] In addition to the above, in this example, the first position-sensing loop 140A includes three coils 142A, 142B, and 142C (i.e., the first coil 142A, the second coil 142B, and the third coil 142C) extending around the same region of the flexible circuit 150. However, without departing from the spirit and scope of the present disclosure, a different number of coils 142 may be used (described in more detail below). Figures 6A to 6E show portions of the flexible circuit 150 that illustrate an exemplary routing configuration of coils 142A to 142C. As seen in Figure 6A, the first position-sensing loop 140A extends from a first distal end 141A (which may include a solder pad 141A) to a second distal end 141B (which may include a solder pad 141B), both of which are proximal to each other on the base 151 of the flexible circuit 150.

[0049] To prevent electrical short circuits, coils 142A to 142C are routed so as not to touch each other. As a result, the position sensing loop 140A has a helical shape, the first soldering pad 141A is located on the outer portion of the helical shape on the first surface 150A of the flexible substrate 150-1, and the second soldering pad 141B is located on the inner portion of the helical shape on the first surface 150A of the flexible substrate 150-1. See Figures 6A to 6E for reference. For example, as seen in Figure 6B, each of the coils 142A to 142C is also routed to pass around the electrode 160 (to also prevent electrical short circuits) and not to touch the electrode 160.

[0050] This routing can be used in various configurations without departing from the spirit and scope of this disclosure. For example, as seen in Figure 6B, the first coil 142A and the second coil 142B pass to the left near the electrode 160 on the first tine 152, and the third coil 142C passes to the right near the electrode 160 on the first tine 152. In contrast, on the third tine 154, the three coils 142A to 142C pass near the electrode 160 on the same side (this prevents crossing paths with the second position sensing loop 140B, as will be described in more detail below). As can be seen in Figure 6C, around another electrode 160 (for example, the top of the second tine 153), the first coil 142A can pass alongside electrode 160 on one side, while the second coil 142B and the third coil 142C pass alongside electrode 160 on the same side.

[0051] As shown in Figure 4, the second position sensing loop 140B is symmetric to the first position sensing loop 140 with respect to the longitudinal axis 60 and is generally divided into a first segment 140B-1 and a second segment 140B-2. The first segment 140B-1 is routed along the fifth tine 156 and the lateral portion of the distal connection segment 158, while the second segment 140B-2 is routed along the third tine 154 (approximately parallel to the second segment 140A-2 of the first position sensing loop 140A) and the second intermediate connection segment 157B. These segments 140B-1 and 140B-2 converge together on the distal portion 151A of the base 151 and on the fourth tine 155 (offset from the longitudinal axis 60).

[0052] In addition to the above, the second position-sensing loop 140B, like the first position-sensing loop 140A, includes three coils 144A, 144B, and 144C (i.e., the first coil 144A, the second coil 144B, and the third coil 144C) extending around the same region of the flexible circuit 150. However, without departing from the spirit and scope of the present disclosure, other numbers of coils 144 may be used (described in more detail below). As seen in Figure 6A, the second position-sensing loop 140A extends from a first distal end 141D (which may include a solder pad 141D) to a second distal end 141C (which may include a solder pad 141C), both of which are proximal to each other on the base 151 of the flexible circuit 150.

[0053] To prevent electrical short circuits, coils 144A-144C are routed so as not to contact each other, similar to the first position sensing loop 140A. Thus, the second position sensing loop 140B has a helical shape, with the first soldering pad 141D positioned on the outer portion of the helical shape on the first surface 150A of the flexible substrate 150-1, and the second soldering pad 141C positioned on the inner portion of the helical shape on the first surface 150A of the flexible substrate 150-1. See Figures 6A-6E for reference. For example, as seen in Figure 6B, each of the coils 142A-142C is also routed so that they pass around the electrode 160 along their respective paths, without contacting the electrode 160 (also to prevent electrical short circuits). Note that the second position sensing loop 140B can take a path that is nearly mirror-image of the path of the first position sensing loop 140A, or a different path, depending on the design requirements. As described above, this routing can be used in various configurations without departing from the spirit and scope of this disclosure. In particular, as shown in Figure 6D, the first position sensing loop 140A and the second position sensing loop 140B converge together along the connection segment 157 on the third tine 154.

[0054] Referring here to Figure 5, the second flexible circuit 110 shares the same design concept as the first flexible circuit 150, but differs in the configuration of the position sensing loop 140. Specifically referring to Figure 5, the second flexible circuit 110 includes a flexible substrate 110-1, a central tine 114 extending along the longitudinal axis 60, and offset tines 112, 113, 115, and 116 offset from the longitudinal axis 60. More specifically, the offset tines 112, 113, 115, and 116 extend away from the longitudinal axis 60, and then roughly along / parallel to it, from the base 111. Multiple electrodes 160 are arranged on each tine 112-116. The electrodes 160 can be arranged along the tines 112-116 so as to be aligned with the electrodes 160 on adjacent tines 112-116 along the longitudinal axis 60. In other examples, the electrodes 160 do not have to be aligned with respect to electrodes 160 on adjacent tines in the direction across the longitudinal axis 60, but rather they may be staggered (i.e., alternating) so that they are arranged in a pattern of alternating alignment from tine to tine.

[0055] The tines 112-116 include a first tine 112 extending from the base 111 along the longitudinal axis 60, a second tine 113 extending from the base 111 along the longitudinal axis 60, a third tine 114 extending from the base along the longitudinal axis, a fourth tine 115 extending from the base along the longitudinal axis, and a fifth tine 116 extending from the base along the longitudinal axis. As can be seen in Figure 5, the first to fifth tines 112-116 are arranged continuously from left to right. The second flexible circuit 110 further includes a first intermediate connection segment 117 connecting the second tine 112 and the third tine 114, a second intermediate connection segment 117 connecting the third tine 114 and the fourth tine 115 toward the distal end of the flexible circuit 110, and a connecting distal segment 118 connecting the distal ends of the first tine 113, the second tine 113, the third tine 114, the fourth tine 115, and the fifth tine 116.

[0056] The tines 112-116, connecting segment 117, and connecting distal segment 118 collectively define the respective gaps 119A-H between them. This reduction in material can help facilitate folding the end effector 100 into the sheath and / or insertion tool.

[0057] Furthermore, tines 112-116 include connection outer segments that do not include electrodes 160 (unlabeled areas in the lower left and lower right of Figure 5). Rather, these segments help define the shape of the end effector 100 and provide reinforcement / protection to the segments of the flexible circuit 110 that carry the electrical traces 162 and / or electrodes 160.

[0058] Similar to the flexible circuit 150 described herein, it should be noted that not all electrodes 160 on the second flexible circuit 110 described herein need to be exposed via the insulating material 130, and these unexposed electrodes can be used to sense far-field signals for noise reduction in proximity to the tissue contact electrodes. Similarly, far-field signals containing noise or artifacts can be reduced or canceled out against the entire end effector having a reference electrode that does not come into contact with tissue and only with blood.

[0059] Continuing to refer to Figure 5, a single position-sensing loop 140C can be provided on the flexible substrate 110-1 of the second flexible circuit 110. Specifically, as illustrated by the depiction of the first flexible substrate 150-1 in Figure 3B, the electrodes 160 and the position-sensing loop 140 (see coil 142 of the position-sensing loop 140) are arranged on the same surface of the flexible substrate.

[0060] The position sensing loop 140C functions as a position sensor having one or more coils (each coil corresponding to a single turn of its respective position sensing loop) that each have a trace that induces a current indicating the position and / or shape of the end effector 100 when exposed to a magnetic field. Each coil includes a surface area defined by the area enclosed by its respective coil, corresponding to a specific region of the flexible circuit 150. By providing multiple coils within the position sensing loop 140, the total surface area covered by the loop 140 can be increased. Furthermore, by placing the position sensing loop 140 on the same layer of the end effector 100 as the electrodes 160, the electrode traces 162 can be shifted closer to the neutral plane of the end effector 100 (compared to end effectors where the sensing loop 140 requires its own flexible circuit layer), which minimizes distortion on these traces 162 and reduces the complexity of the end effector 100.

[0061] In the example of the second flexible circuit 110, as described above, there is a single position sensing loop 140C containing one or more coils 146A to 146C. The first position sensing loop 140A and the second position sensing loop 140B each contain one or more coils 142. The first position sensing loop 140A generally extends along a base 151, a first tine 152, a connecting distal segment 158, a second tine 153, a first intermediate connecting segment 157A, and a third tine 154. The second position sensing loop 140B generally extends along a base 151, a fifth tine 156, a connecting distal segment 158, a fourth tine 155, a second intermediate connecting segment 157B, and a third tine 154.

[0062] As shown in Figure 4, the first position sensing loop 140A is generally divided by the longitudinal axis 60 into a first segment 140C-1 and a second segment 140C-2. The first segment 140C-1 is routed along a second tine 112 (approximately parallel to the longitudinal axis 60) and one of the connecting segments 117, while the second segment 140C-2 is routed along a fourth tine 115 (approximately parallel to the longitudinal axis 60) and another connecting segment 157. These segments 140C-1 and 140C-2 converge together on the distal portion of the base 111 and on the third tine 114 (located on / along the longitudinal axis 60, as described above).

[0063] In addition to the above, in this example, the position sensing loop 140C includes three coils 146A, 146B, and 146C (i.e., the first coil 146A, the second coil 146B, and the third coil 146C) extending around the same area of ​​the flexible circuit 110. However, without departing from the spirit and scope of this disclosure, a different number of coils 146 may be used (described in more detail below). Although the specific routing of each coil 146A-146C is not explicitly shown, those skilled in the art will understand that the position sensing loop 140C of a second flexible circuit 110 may employ the same routing principles as described above, as well as the same design concepts, such as the helical shape (connected to solder pads 141E, 141F at its distal end).

[0064] Referring briefly to Figure 7, as described above, the technology of the present disclosure can use a different number of coils without departing from the spirit and scope of the present disclosure. For example, the alternative flexible circuit 150' may include a first position sensing loop and a second position sensing loop, each containing two coils 142A', 142B' and 144A', 144B', respectively, instead of three coils.

[0065] This disclosure provides a medical probe assembly 200, as shown in Figure 8, which may include a tubular member 230 extending along a longitudinal axis 60 and configured to deliver an end effector 100 outside the sheath 210. A physician 24 can operate the catheter assembly 200 using a handle 220. Suitable examples of the catheter assembly 200, as well as its subcomponents such as the handle 220, the sheath 210, the tubular member 230, and others not mentioned herein, are described in U.S. Patent Application Publication No. 2021 / 0369339, which is incorporated herein by reference.

[0066] In addition to the embodiments described above, referring to Figure 9, a method 900 for manufacturing an end effector for a medical device may include the following: The method includes forming a plurality of electrodes on a first surface of a plurality of tines of a flexible circuit 902, the plurality of tines extending substantially parallel to the longitudinal axis. The first surface is common across the tines and is of the flexible substrate described above. The method includes forming a position-sensing loop on the first surface (904). The position-sensing loop forms one or more coils configured to generate a current, the current indicating the position of one or more coils when one or more coils are exposed to a magnetic field. The position-sensing loop comprises two segments that (i) extend along each of the plurality of tines and (ii) are positioned on the longitudinal axis or offset from the longitudinal axis and converge toward each other on one of the plurality of tines. The position-sensing loop is routed so as not to contact the electrodes. The position-sensing loop is routed in a helical shape. The method further includes forming an electrical trace on a second surface of the flexible circuit (906). As described above, by forming a position sensing loop on the same flexible circuit as the electrodes, the total number of layers of flexible circuitry within the end effector 100 can be reduced.

[0067] The technologies of this disclosure described herein can be further understood in accordance with the following provisions.

[0068] Clause 1. A flexible circuit for an end effector of a medical probe, the flexible circuit comprising: a flexible substrate defining a plurality of tines extending along a longitudinal axis; a plurality of electrodes disposed on each of the plurality of tines; and a first sensing loop disposed on the flexible substrate, wherein the first position sensing loop forms one or more coils configured to generate a current, the current indicating the position of one or more coils when one or more coils are exposed to a magnetic field; and the first position sensing loop comprises two segments disposed on each of the plurality of tines extending substantially parallel to the longitudinal axis and converging toward each other on the tines of the plurality of tines disposed on the longitudinal axis.

[0069] Clause 2. The flexible circuit according to Clause 1, wherein the flexible substrate comprises a first surface and a second surface, and electrodes and one or more sensing loops are both located on the first surface.

[0070] Clause 3. The flexible circuit according to Clause 2, further comprising one or more electrical interconnects electrically connected to electrodes and arranged along a second surface.

[0071] Clause 4. A flexible circuit as described in Clause 2 or 3, wherein one or more coils are routed along the path of one or more coils and along the flexible substrate, passing around each electrode of a plurality of electrodes.

[0072] Clause 5. A flexible circuit according to any one of Clauses 1 to 4, wherein at least one coil comprises a first coil extending around a region of the flexible substrate and a second coil extending around a region of the flexible substrate.

[0073] Clause 6. The flexible circuit according to Clause 5, wherein at least one coil comprises a third coil extending around an area of ​​the flexible substrate.

[0074] Clause 7. The flexible circuit as described in Clause 6, wherein the first coil, the second coil, and the third coil are routed along a flexible substrate such that the first and second coils pass around the electrode on the first side of the electrode and the third coil passes around the electrode on the second side opposite the electrode.

[0075] Clause 8. The flexible circuit as described in Clause 6, wherein the first coil, the second coil, and the third coil are routed along the flexible substrate such that the first coil, the second coil, and the third coil pass around the electrode on the same side of the electrode.

[0076] Clause 9. Each position-sensing loop is a flexible circuit as described in any one of Clauses 1 to 8, extending from a first distal end to a second distal end.

[0077] Clause 10. The flexible circuit described in Clause 9, wherein the first distal end and the second distal end are located at the proximal end of the flexible circuit.

[0078] Clause 11. The flexible circuit according to Clause 9 or 10, wherein the first distal end comprises a first soldering pad and the second distal end comprises a second soldering pad.

[0079] Clause 12. The flexible circuit according to Clause 11, comprising a base, with a first soldering pad and a second soldering pad located on the base.

[0080] Clause 13. A flexible circuit according to Clause 11 or 12, wherein each position-sensing loop includes a helical shape defining one or more coils, a first soldering pad located on the outer portion of the helical shape on a first surface of the flexible substrate, and a second soldering pad located on the inner portion of the helical shape on the first surface of the flexible substrate.

[0081] Clause 14. Each position-sensing loop is a flexible circuit as described in any one of Clauses 9 to 12, comprising a helical shape defining one or more coils.

[0082] Clause 15. Each coil corresponds to a single turn of the respective position-sensing loop, as described in Clause 14.

[0083] Clause 16. The flexible substrate comprises a base, a first intermediate connection segment, a second intermediate connection segment, and a connecting distal segment, wherein the plurality of tines include a first tine extending from the base along the longitudinal axis, a second tine extending from the base along the longitudinal axis, and a third tine extending from the base along the longitudinal axis, wherein the tines where two segments converge toward each other correspond to the third tine, and along the longitudinal axis A flexible circuit according to any one of clauses 1 to 15, comprising a fourth tine extending from the base along the longitudinal axis and a fifth tine extending from the base along the longitudinal axis, wherein a first intermediate connecting segment connects the second tine and the third tine, a second intermediate connecting segment connects the third tine and the fourth tine, and a connecting distal segment connects the distal ends of the first tine, the second tine, the third tine, the fourth tine, and the fifth tine.

[0084] Clause 17. The flexible circuit as described in Clause 16, comprising the first tine, the second tine, the third tine, the fourth tine, the fifth tine, the first intermediate connection segment, and the second intermediate connection segment, each defining a gap between them.

[0085] Clause 18. The flexible circuit according to Clause 16 or 17, wherein the first position-sensing loop extends along the base, the second tine, the first intermediate connecting segment, the third tine, the second intermediate connecting segment, and the fourth tine, and the two segments converge toward each other on the third tine and the base.

[0086] Clause 19. Each coil includes a surface area defined by the area surrounding each coil, where each area corresponds to a region of the flexible circuit as described in any one of Clauses 1 to 18.

[0087] Clause 20. A flexible circuit as described in any one of Clauses 1 to 19, in which current represents the shape of a part of the flexible circuit.

[0088] Clause 21. A flexible circuit for an end effector of a medical probe, comprising: a flexible substrate defining a plurality of tines extending along a longitudinal axis; a plurality of electrodes disposed on each of the plurality of tines; and a first sensing loop and a second sensing loop disposed on the flexible substrate, wherein each of the first position sensing loop and the second position sensing loop forms one or more coils configured to generate a current, the current indicating the position of one or more coils when one or more coils are exposed to a magnetic field; the first position sensing loop includes two segments disposed on each of the plurality of tines, the two segments extending along a longitudinal axis and converging toward each other on one of the plurality of tines offset from the longitudinal axis; and the second position sensing loop includes two segments disposed on each of the plurality of tines, the two segments extending along a longitudinal axis and converging toward each other on another of the plurality of tines offset from the longitudinal axis;

[0089] Clause 22. The flexible circuit according to Clause 21, wherein the flexible substrate comprises a first surface and a second surface, and electrodes and one or more sensing loops are both located on the first surface.

[0090] Clause 23. The flexible circuit according to Clause 22, further comprising one or more electrical interconnects electrically connected to electrodes and arranged along a second surface.

[0091] Clause 24. A flexible circuit as described in Clause 22 or 23, in which one or more coils are routed along a flexible substrate, passing around electrodes.

[0092] Clause 25. A flexible circuit according to any one of Clauses 21 to 24, wherein at least one coil comprises a first coil extending around a region of the flexible substrate and a second coil extending around a region of the flexible substrate.

[0093] Clause 26. A flexible circuit as described in Clause 25, wherein at least one coil comprises a third coil extending around an area of ​​the flexible substrate.

[0094] Clause 27. The flexible circuit as described in Clause 26, wherein the first coil, the second coil, and the third coil are routed along a flexible substrate such that the first coil and the second coil pass around the first electrode on the first side of the plurality of electrodes, and the third coil passes around the first electrode on the second side opposite the first electrode.

[0095] Clause 28. The flexible circuit as described in Clause 26, wherein the first coil, the second coil, and the third coil are routed along a flexible substrate such that they pass around the first electrode of a plurality of electrodes, on the same side of the first electrode.

[0096] Clause 29. Each position-sensing loop is a flexible circuit as described in any one of Clauses 21 to 28, extending from a first distal end to a second distal end.

[0097] Clause 30. The flexible circuit described in Clause 29, wherein the first distal end and the second distal end are located at the proximal end of the flexible circuit.

[0098] Clause 31. The flexible circuit according to Clause 29 or 30, wherein the first distal end comprises a first soldering pad and the second distal end comprises a second soldering pad.

[0099] Clause 32. The flexible circuit according to Clause 31, comprising a base, with a first soldering pad and a second soldering pad located on the base.

[0100] Clause 33. The flexible circuit according to Clause 31 or 32, wherein each position-sensing loop comprises a helical shape defining one or more coils, a first soldering pad located on the outer portion of the helical shape on a first surface of the flexible substrate, and a second soldering pad located on the inner portion of the helical shape on the first surface of the flexible substrate.

[0101] Clause 34. Each position-sensing loop comprises a helical shape defining one or more coils, as described in any one of Clauses 29 to 32.

[0102] Clause 35. Each coil corresponds to a single turn of the respective position-sensing loop, as described in Clause 34, in the flexible circuit.

[0103] Clause 36. The flexible substrate comprises a base, a first intermediate connection segment, a second intermediate connection segment, and a connecting distal segment, wherein the plurality of tines include a first tine extending from the base along the longitudinal axis, a second tine extending from the base along the longitudinal axis, wherein the tine where two segments of the first position sensing loop converge toward each other corresponds to the second tine, a third tine extending from the base along the longitudinal axis, and a fourth tine extending from the base along the longitudinal axis, A flexible circuit according to any one of the clauses 21 to 35, comprising: a fourth tine, wherein two segments of the sensing loop converge toward each other, and a fifth tine extending from the base along the longitudinal axis, wherein a first intermediate connecting segment connects the second tine and the third tine; a second intermediate connecting segment connects the third tine and the fourth tine; and a connecting distal segment connects the distal ends of the first tine, the second tine, the third tine, the fourth tine, and the fifth tine.

[0104] Clause 37. The flexible circuit as described in Clause 36, comprising a first tine, a second tine, a third tine, a fourth tine, a fifth tine, a first intermediate connection segment, and a second intermediate connection segment, each defining a gap between them.

[0105] Clause 38. The flexible circuit as described in Clause 36 or 37, wherein the first position-sensing loop extends along the base, the first tine, the connecting distal segment, the second tine, the first intermediate connecting segment, and the third tine.

[0106] Clause 39. The second sensing loop extends along the base, the fifth tine, the connecting distal segment, the fourth tine, the second intermediate connecting segment, and the third tine, as described in any one of Clauses 36 to 38 of the flexible circuit.

[0107] Clause 40. Each coil includes a surface area defined by the area surrounding each coil, where each area corresponds to a region of the flexible circuit as described in any one of Clauses 21 to 39.

[0108] Clause 41. A flexible circuit as described in any one of Clauses 21 to 40, which represents the shape of a part of a flexible circuit.

[0109] Clause 42. An end effector for a medical probe, the end effector comprising an insulating material, a framework which is substantially planar along the longitudinal axis, and a first flexible circuit disposed within the insulating material so as to be spaced apart from the framework along the vertical axis, the first flexible circuit comprising a first flexible circuit defining a first plurality of tines extending along the longitudinal axis, a first plurality of electrodes disposed on each of the first plurality of tines, and a first sensing loop and a second sensing loop disposed on a first flexible substrate, each of the first sensing loop and the second sensing loop being configured to generate current An end effector comprising: forming a coil on top, the current indicating the position of one or more coils when one or more coils are exposed to a magnetic field, a first position sensing loop positioned on each of a plurality of first tines extending along a longitudinal axis and comprising two segments converging toward each other on a tine offset from the longitudinal axis of the plurality of first tines, and a second sensing loop positioned on each of a plurality of first tines extending along a longitudinal axis and comprising two segments converging toward each other on another tine offset from the longitudinal axis of the plurality of first tines.

[0110] Clause 43. The end effector according to Clause 42, wherein a first sensing loop extends over a first side of a first flexible circuit, a second sensing loop extends over a second side of the first flexible circuit, and the second side position sensing loop is arranged substantially symmetrically with respect to the first side position sensing loop about a longitudinal axis.

[0111] Clause 44. The end effector according to Clause 42 or 43, further comprising: a second flexible circuit disposed in an insulating material so as to be spaced apart from the framework and the first flexible circuit along a vertical axis, the second flexible circuit comprising: a second flexible substrate defining a second plurality of tines extending along a longitudinal axis; a second plurality of electrodes disposed on each of the second plurality of tines; and a third sensing loop disposed on the second flexible substrate, the third sensing loop forming one or more coils configured to generate a current, the current indicating the position of one or more coils when one or more coils are exposed to a magnetic field, and the third sensing loop comprising two segments disposed on each of the second plurality of tines, the two segments extending substantially parallel to the longitudinal axis and converging toward each other on the first tine of the second plurality of tines disposed along the longitudinal axis.

[0112] Clause 45. The third position-sensing loop is arranged substantially symmetrically with respect to the longitudinal axis, as per the end effector of Clause 44.

[0113] Clause 46. A method comprising forming a plurality of electrodes on a first surface of a plurality of tines of a flexible circuit, wherein the plurality of tines extend substantially parallel to a longitudinal axis; and forming a position-sensing loop on the first surface, wherein the position-sensing loop forms one or more coils configured to generate a current, the current indicating the position of one or more coils when exposed to a magnetic field, and the position-sensing loop comprises two segments that (i) extend along each of the plurality of tines and (ii) are positioned on the longitudinal axis or converge toward each other on one of the plurality of tines offset from the longitudinal axis.

[0114] Clause 47. Forming a position-sensing loop is the method of Clause 46, which includes routing the position-sensing loop so that it does not come into contact with an electrode.

[0115] Clause 48. Forming a position-sensing loop is the method of Clause 46 or 47, which includes routing the position-sensing loop in a spiral shape.

[0116] Clause 49. The method according to any one of Clauses 46 to 48, further comprising forming an electrical trace on a second surface of a flexible circuit.

[0117] Clause 50. An end effector for a medical probe, the end effector comprising an insulating material and a framework disposed within the insulating material, the framework being substantially planar along a longitudinal axis, and a first flexible circuit disposed within or on the insulating material, the first flexible circuit comprising a first flexible substrate defining a first plurality of tines extending along a longitudinal axis, a first plurality of electrodes disposed on each of the first plurality of tines, and a first plurality of sensing loops and a second sensing loop disposed on the first flexible substrate, each of the first sensing loops and the second sensing loop configured to generate current. An end effector comprising: forming one or more coils, the current indicating the position of one or more coils when one or more coils are exposed to a magnetic field, the first position sensing loop being positioned on each of the first plurality of tines extending along a longitudinal axis and comprising two segments converging toward each other on tines offset from the longitudinal axis of the first plurality of tines, and the second sensing loop being positioned on each of the first plurality of tines extending along a longitudinal axis and comprising two segments converging toward each other on another tine offset from the longitudinal axis of the first plurality of tines.

[0118] Clause 51. The end effector of Clause 50, wherein the first flexible circuit is substantially planar along the longitudinal axis.

[0119] Clause 52. The first flexible circuit is an end effector as described in Clause 51, extending substantially parallel to the framework.

[0120] Clause 53. The end effector according to Clause 50 or 51, wherein the first flexible circuit comprises a first part and a second part along a longitudinal axis, the first part being positioned at a first distance from the framework along a vertical axis, and the second part being positioned at a second distance from the framework along a vertical axis, the second distance being different from the first distance.

[0121] The embodiments described above are cited as examples, and the technology of this disclosure is not limited to those specifically illustrated and described in the above specification. Rather, the scope of the technology of this disclosure includes both combinations and partial combinations of the various features described above, as well as variations and modifications thereof not disclosed in the prior art, which a person skilled in the art would conceive of by reading the above description.

[0122] [Implementation Method] (1) A flexible circuit for the end effector of a medical probe, wherein the flexible circuit is A flexible substrate defining multiple tines extending along the longitudinal axis, A plurality of electrodes arranged in each of the plurality of tines, The flexible substrate comprises a first sensing loop disposed on the flexible substrate, The first sensing loop forms one or more coils configured to generate an electric current, the current indicating the position of the one or more coils when they are exposed to a magnetic field. The first sensing loop is a flexible circuit comprising two segments, each positioned on one of the plurality of tines extending substantially parallel to the longitudinal axis, and converging toward each other on the tine positioned on the longitudinal axis. (2) The flexible circuit according to Embodiment 1, wherein the flexible substrate comprises a first surface and a second surface, and the plurality of electrodes and the one or more sensing loops are both located on the first surface. (3) The flexible circuit according to Embodiment 2, further comprising one or more electrical interconnections electrically connected to the plurality of electrodes and arranged along the second surface. (4) The flexible circuit according to Embodiment 2, wherein the one or more coils are routed along the path of the one or more coils and along the flexible substrate, passing around each of the plurality of electrodes. (5) The flexible circuit according to Embodiment 1, wherein the one or more coils comprises a first coil extending around a region of the flexible substrate and a second coil extending around the region of the flexible substrate.

[0123] (6) The flexible circuit according to Embodiment 5, wherein the one or more coils include a third coil extending around the region of the flexible substrate. (7) The flexible circuit according to Embodiment 6, wherein the first coil, the second coil, and the third coil are routed along the flexible substrate such that they pass around the first electrode of the plurality of electrodes on the same side of the first electrode. (8) The flexible circuit according to Embodiment 1, wherein each position sensing loop extends from a first distal end to a second distal end. (9) The flexible circuit according to Embodiment 8, wherein the first distal end and the second distal end are located at the proximal end of the flexible circuit. (10) The flexible circuit according to Embodiment 8, wherein the first distal end is provided with a first soldering pad and the second distal end is provided with a second soldering pad.

[0124] (11) The flexible circuit according to Embodiment 10, wherein each position-sensing loop includes a helical shape defining one or more coils, the first soldering pad is located on the outer portion of the helical shape on the first surface of the flexible substrate, and the second soldering pad is located on the inner portion of the helical shape on the first surface of the flexible substrate. (12) The flexible circuit according to Embodiment 8, wherein each position sensing loop includes a helical shape defining one or more coils. (13) The flexible substrate comprises a base, a first intermediate connection segment, a second intermediate connection segment, and a connecting distal segment, and the plurality of tines are A first tine extending from the base along the longitudinal axis, A second tine extending from the base along the longitudinal axis, A third tine extending from the base along the longitudinal axis, wherein the tine where the two segments converge toward each other corresponds to the third tine, A fourth tine extending from the base along the longitudinal axis, It comprises a fifth tine extending from the base along the longitudinal axis, The first intermediate connection segment connects the second tine and the third tine, The second intermediate connection segment connects the third tine and the fourth tine. The flexible circuit according to Embodiment 1, wherein the connecting distal segment connects the distal ends of the first tine, the second tine, the third tine, the fourth tine, and the fifth tine. (14) The flexible circuit according to Embodiment 13, wherein the first sensing loop extends along the base, the second tine, the first intermediate connection segment, the third tine, the second intermediate connection segment, and the fourth tine, and the two segments converge toward each other on the third tine and the base. (15) The flexible circuit according to Embodiment 1, wherein each coil includes a surface area defined by the area surrounding each coil, and each area corresponds to the region of the flexible circuit.

[0125] (16) A flexible circuit for an end effector of a medical probe, wherein the flexible circuit is A flexible substrate defining multiple tines extending along the longitudinal axis, A plurality of electrodes arranged in each of the plurality of tines, The flexible substrate comprises a first sensing loop and a second sensing loop arranged on the flexible substrate, Each of the first sensing loop and the second sensing loop forms one or more coils configured to generate an electric current, the current indicates the position of the one or more coils when they are exposed to a magnetic field. The first sensing loop comprises two segments, each positioned on one of the plurality of tines extending along the longitudinal axis, and converging toward each other on a tine offset from the longitudinal axis among the plurality of tines. The second sensing loop is a flexible circuit comprising two segments positioned on each of the plurality of tines extending along the longitudinal axis, and converging toward each other on another tine of the plurality of tines offset from the longitudinal axis. (17) The flexible substrate comprises a base, a first intermediate connection segment, a second intermediate connection segment, and a connecting distal segment, and the plurality of tines are A first tine extending from the base along the longitudinal axis, A second tine extending from the base along the longitudinal axis, wherein the tine on which the two segments of the first sensing loop converge toward each other corresponds to the second tine, A third tine extending from the base along the longitudinal axis, A fourth tine extending from the base along the longitudinal axis, wherein the other tine on which the two segments of the second sensing loop converge toward each other corresponds to the fourth tine, It comprises a fifth tine extending from the base along the longitudinal axis, The first intermediate connection segment connects the second tine and the third tine, The second intermediate connection segment connects the third tine and the fourth tine. The flexible circuit according to embodiment 16, wherein the connecting distal segment connects the distal ends of the first tine, the second tine, the third tine, the fourth tine, and the fifth tine. (18) The flexible circuit according to Embodiment 17, wherein the first sensing loop extends along the base, the first tine, the connecting distal segment, the second tine, the first intermediate connecting segment, and the third tine. (19) The flexible circuit according to Embodiment 17, wherein the second sensing loop extends along the base, the fifth tine, the connecting distal segment, the fourth tine, the second intermediate connecting segment, and the third tine. (20) An end effector for a medical probe, wherein the end effector is insulating materials, A framework disposed within the insulating material, wherein the framework is substantially planar along the longitudinal axis, and The first flexible circuit is disposed within the insulating material so as to be spaced apart from the framework along a vertical axis, and the first flexible circuit is A first flexible substrate defining a plurality of first tines extending along the longitudinal axis, A first plurality of electrodes arranged in each of the first plurality of tines, The system comprises a first sensing loop and a second sensing loop arranged on the first flexible substrate, Each of the first sensing loop and the second sensing loop forms one or more coils configured to generate an electric current, the current indicates the position of the one or more coils when they are exposed to a magnetic field. The first sensing loop comprises two segments that are positioned on each of the first plurality of tines extending along the longitudinal axis and converge toward each other on tines offset from the longitudinal axis among the first plurality of tines, The end effector comprises two segments, each positioned on one of the first plurality of tines extending along the longitudinal axis, and converging toward each other on another tine of the first plurality of tines offset from the longitudinal axis.

Claims

1. A flexible circuit for the end effector of a medical probe, wherein the flexible circuit is A flexible substrate defining multiple tines extending along the longitudinal axis, A plurality of electrodes arranged in each of the plurality of tines, The flexible substrate comprises a first sensing loop disposed on the flexible substrate, The first sensing loop forms one or more coils configured to generate an electric current, the current indicating the position of the one or more coils when they are exposed to a magnetic field. The first sensing loop is a flexible circuit comprising two segments, each positioned on one of the plurality of tines extending substantially parallel to the longitudinal axis, and converging toward each other on the tine positioned on the longitudinal axis.

2. The flexible circuit according to claim 1, wherein the flexible substrate comprises a first surface and a second surface, and both the plurality of electrodes and the one or more sensing loops are arranged on the first surface.

3. The flexible circuit according to claim 2, further comprising one or more electrical interconnections electrically connected to the plurality of electrodes and arranged along the second surface.

4. The flexible circuit according to claim 2, wherein the one or more coils are routed along the path of the one or more coils and along the flexible substrate, passing around each of the plurality of electrodes.

5. The flexible circuit according to claim 1, wherein the one or more coils comprises a first coil extending around a region of the flexible substrate and a second coil extending around the region of the flexible substrate.

6. The flexible circuit according to claim 5, wherein the one or more coils include a third coil extending around the region of the flexible substrate.

7. The flexible circuit according to claim 6, wherein the first coil, the second coil, and the third coil are routed along the flexible substrate such that they pass around the first electrode of the plurality of electrodes on the same side of the first electrode.

8. The flexible circuit according to claim 1, wherein each position-sensing loop extends from a first distal end to a second distal end.

9. The flexible circuit according to claim 8, wherein the first distal end and the second distal end are located at the proximal end of the flexible circuit.

10. The flexible circuit according to claim 8, wherein the first distal end is provided with a first soldering pad, and the second distal end is provided with a second soldering pad.

11. The flexible circuit according to claim 10, wherein each position-sensing loop includes a helical shape defining one or more coils, the first soldering pad is located on the outer portion of the helical shape on the first surface of the flexible substrate, and the second soldering pad is located on the inner portion of the helical shape on the first surface of the flexible substrate.

12. The flexible circuit according to claim 8, wherein each position sensing loop includes a helical shape defining one or more coils.

13. The flexible substrate comprises a base, a first intermediate connection segment, a second intermediate connection segment, and a connecting distal segment, and the plurality of tines are A first tine extending from the base along the longitudinal axis, A second tine extending from the base along the longitudinal axis, A third tine extending from the base along the longitudinal axis, wherein the tine where the two segments converge toward each other corresponds to the third tine, A fourth tine extending from the base along the longitudinal axis, It comprises a fifth tine extending from the base along the longitudinal axis, The first intermediate connection segment connects the second tine and the third tine. The second intermediate connection segment connects the third tine and the fourth tine. The flexible circuit according to claim 1, wherein the connecting distal segment connects the distal ends of the first tine, the second tine, the third tine, the fourth tine, and the fifth tine.

14. The flexible circuit according to claim 13, wherein the first sensing loop extends along the base, the second tine, the first intermediate connection segment, the third tine, the second intermediate connection segment, and the fourth tine, and the two segments converge toward each other on the third tine and the base.

15. The flexible circuit according to claim 1, wherein each coil includes a surface area defined by the area surrounding each coil, and each area corresponds to the region of the flexible circuit.

16. A flexible circuit for the end effector of a medical probe, wherein the flexible circuit is A flexible substrate defining multiple tines extending along the longitudinal axis, A plurality of electrodes arranged in each of the plurality of tines, The flexible substrate comprises a first sensing loop and a second sensing loop arranged on the flexible substrate, Each of the first sensing loop and the second sensing loop forms one or more coils configured to generate an electric current, the current indicating the position of the one or more coils when they are exposed to a magnetic field. The first sensing loop comprises two segments, each positioned on one of the plurality of tines extending along the longitudinal axis, and converging toward each other on a tine offset from the longitudinal axis among the plurality of tines. The second sensing loop is a flexible circuit comprising two segments positioned on each of the plurality of tines extending along the longitudinal axis, and converging toward each other on another tine of the plurality of tines offset from the longitudinal axis.

17. The flexible substrate comprises a base, a first intermediate connection segment, a second intermediate connection segment, and a connecting distal segment, and the plurality of tines are A first tine extending from the base along the longitudinal axis, A second tine extending from the base along the longitudinal axis, wherein the tine on which the two segments of the first sensing loop converge toward each other corresponds to the second tine, A third tine extending from the base along the longitudinal axis, A fourth tine extending from the base along the longitudinal axis, wherein the other tine on which the two segments of the second sensing loop converge toward each other corresponds to the fourth tine, It comprises a fifth tine extending from the base along the longitudinal axis, The first intermediate connection segment connects the second tine and the third tine. The second intermediate connection segment connects the third tine and the fourth tine. The flexible circuit according to claim 16, wherein the connecting distal segment connects the distal ends of the first tine, the second tine, the third tine, the fourth tine, and the fifth tine.

18. The flexible circuit according to claim 17, wherein the first sensing loop extends along the base, the first tine, the connecting distal segment, the second tine, the first intermediate connecting segment, and the third tine.

19. The flexible circuit according to claim 17, wherein the second sensing loop extends along the base, the fifth tine, the connecting distal segment, the fourth tine, the second intermediate connecting segment, and the third tine.

20. An end effector for a medical probe, wherein the end effector is insulating materials, A framework disposed within the insulating material, wherein the framework is substantially planar along the longitudinal axis, and The first flexible circuit is disposed within the insulating material so as to be spaced apart from the framework along a vertical axis, and the first flexible circuit is A first flexible substrate defining a plurality of first tines extending along the longitudinal axis, A plurality of first electrodes arranged in each of the first plurality of tines, The system comprises a first sensing loop and a second sensing loop arranged on the first flexible substrate, Each of the first sensing loop and the second sensing loop forms one or more coils configured to generate an electric current, the current indicating the position of the one or more coils when they are exposed to a magnetic field. The first sensing loop comprises two segments that are positioned on each of the first plurality of tines extending along the longitudinal axis and converge toward each other on tines offset from the longitudinal axis among the first plurality of tines, The end effector comprises two segments, each positioned on one of the first plurality of tines extending along the longitudinal axis, and converging toward each other on another tine of the first plurality of tines offset from the longitudinal axis.

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