Planar conduit with sensing loop and electrodes on the same flexible circuit

Abstract

The disclosed technology includes a flexible circuit for an end effector of a medical probe. The flexible circuit includes a flexible substrate, electrodes, and a first sensing ring. The flexible substrate defines fangs extending along a longitudinal axis. Electrodes are disposed on each of the fangs. The first sensing ring is disposed on the flexible substrate. The first sensing ring forms one or more coils that generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field. The first sensing ring includes two segments disposed on corresponding fangs, the two segments extending generally parallel to the longitudinal axis and converging towards each other on the fangs disposed on the longitudinal axis.

Description

Technical Field

[0001] This technology relates generally to medical devices, and more specifically to medical probes having electrodes, and further but not exclusively to medical probes suitable for mapping and / or ablation of tissues. Background Technology

[0002] When areas of the heart tissue abnormally transmit electrical signals to adjacent tissues, arrhythmias such as atrial fibrillation occur, disrupting the normal cardiac cycle and leading to irregular heartbeats. The source of these unwanted signals can be located in the tissues of the atria or ventricles. These unwanted signals are conducted through the heart tissue to other parts of the body, where they can trigger or perpetuate arrhythmias.

[0003] Treatment protocols for arrhythmias involve surgically disrupting the signal sources causing the arrhythmia, as well as disrupting the conduction pathways used to transmit these signals. Recently, it has been discovered that by mapping the electrical properties of the endocardium and cardiac volume, and selectively ablating cardiac tissue with applied energy, the propagation of unwanted electrical signals from one part of the heart to another can be stopped or altered. Ablation methods destroy unwanted electrical pathways by creating non-conductive ablation foci.

[0004] In this two-step procedure (which includes mapping and ablation), electrical activity at various points in the heart is typically sensed and measured by advancing a catheter containing one or more electrical sensors into the heart and acquiring data at multiple points. This data is then used to select the target area for ablation.

[0005] To achieve higher mapping resolution, mapping catheters are expected to fit closely to the target anatomical structure. For mapping within the atria or ventricles (e.g., the apex of the ventricle), catheters are expected to collect a large amount of data signals over a short time span. Such catheters are also expected to allow for adequate contact between electrodes and diverse tissue surfaces—e.g., flat, curved, irregular, or non-planar tissue surfaces—and to constrict for non-invasive advancement and withdrawal through the patient's vascular system. Existing catheters typically require rigid internal structural members to ensure the maintenance of a predetermined configuration. However, this rigidity is disadvantageous when operating within human organs, as it hinders electrode contact with tissue.

[0006] Other conduits may include flexible end actuators designed to overcome this drawback. These conduits may include 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 delamination during use. Summary of the Invention

[0007] According to the disclosed technology, a flexible circuit for an end effector of a medical probe is provided. The flexible circuit includes: a flexible substrate defining a plurality of teeth extending along a longitudinal axis; a plurality of electrodes disposed on each of the plurality of teeth; and a first sensing ring disposed on the flexible substrate. The first sensing ring forms one or more coils configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field. The first sensing ring includes two segments disposed on corresponding teeth of the plurality of teeth, the two segments extending generally parallel to the longitudinal axis and converging toward each other on the teeth of the plurality of teeth disposed on the longitudinal axis.

[0008] According to the disclosed technology, a flexible circuit for an end effector of a medical probe is also provided. The flexible circuit includes: a flexible substrate defining a plurality of teeth extending along a longitudinal axis; a plurality of electrodes disposed on each of the plurality of teeth; and a first sensing ring and a second sensing ring disposed on the flexible substrate. Each of the first and second sensing rings forms one or more coils configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field. The first sensing ring includes two segments disposed on corresponding teeth of the plurality of teeth, the two segments extending along the longitudinal axis and converging toward each other on a tooth of the plurality of teeth offset from the longitudinal axis. The second sensing ring includes two segments disposed on corresponding teeth of the plurality of teeth, the two segments extending along the longitudinal axis and converging toward each other on another tooth of the plurality of teeth offset from the longitudinal axis.

[0009] According to the disclosed technology, an end effector for a medical probe is also provided. The end effector includes: an insulating material; a frame disposed within the insulating material, the frame being generally planar along a longitudinal axis; and a first flexible circuit disposed within the insulating material such that the first flexible circuit is spaced apart from the frame along a vertical axis. The first flexible circuit includes: a first flexible substrate defining a plurality of first teeth extending along the longitudinal axis; a plurality of first electrodes disposed on each of the plurality of first teeth; and a first sensing ring and a second sensing ring disposed on the first flexible substrate. Each of the first sensing ring and the second sensing ring forms one or more coils configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field. The first sensing ring includes two segments disposed on corresponding teeth of the plurality of first teeth, the two segments extending along the longitudinal axis and converging toward each other on teeth of the plurality of first teeth offset from the longitudinal axis. The second sensing ring includes two segments disposed on corresponding teeth of a plurality of first teeth, the two segments extending along a longitudinal axis and converging toward each other on another tooth of the plurality of first teeth that is offset from the longitudinal axis.

[0010] According to the disclosed technology, a method is also provided, comprising: forming a plurality of electrodes on a first surface of a plurality of teeth of a flexible circuit, the plurality of teeth extending generally parallel to a longitudinal axis; and forming a position sensing ring on the first surface. The position sensing ring forms one or more coils configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field. The position sensing ring includes two segments (i) extending along corresponding teeth of the plurality of teeth, and (ii) converging toward each other on teeth of the plurality of teeth disposed on or offset from the longitudinal axis.

[0011] According to the disclosed technology, an end effector for a medical probe is also provided. The end effector includes: an insulating material; a frame disposed in the insulating material, the frame being generally planar along a longitudinal axis; and a first flexible circuit disposed in or on the insulating material. The first flexible circuit includes: a first flexible substrate defining a plurality of first teeth extending along the longitudinal axis; a plurality of first electrodes disposed on each of the plurality of first teeth; and a first sensing ring and a second sensing ring disposed on the first flexible substrate. Each of the first sensing ring and the second sensing ring forms one or more coils configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field. The first sensing ring includes two segments disposed on corresponding teeth of the plurality of first teeth, the two segments extending along the longitudinal axis and converging toward each other on teeth of the plurality of first teeth offset from the longitudinal axis. The second sensing ring includes two segments disposed on corresponding teeth of a plurality of first teeth, the two segments extending along a longitudinal axis and converging toward each other on another tooth of the plurality of first teeth that is offset from the longitudinal axis. Attached Figure Description

[0012] Figure 1 It is a schematic diagram of a medical system including a medical device according to the disclosed technology, the medical device including a medical probe with an end effector with electrodes; Figure 2A This is a schematic illustration showing an exploded perspective view of an exemplary end effector according to the disclosed technology; Figure 2B It shows the progress along the disclosed technology. Figure 2A A schematic diagram of the cross-section of the assembled end effector taken from line L1 in the diagram; Figure 2C It shows a similarity to the disclosed technology. Figure 2B A schematic diagram of the cross-section, in which the configuration of the assembled end effector has been modified; Figure 2D It shows a similarity to the disclosed technology. Figure 2B A schematic diagram of the cross-section, in which the configuration of the assembled end effector has been modified; Figure 3A This is a schematic diagram showing a portion of the first flexible circuitry of an end effector according to the disclosed technology; Figure 3B It shows the progress along the disclosed technology. Figure 3A A schematic diagram of the cross-section of the first flexible circuit tooth cut from line 3B-3B in the diagram; Figure 4 It is a schematic diagram showing a plan view of a first flexible circuit according to the disclosed technology; Figure 5 This is a schematic diagram showing a plan view of the second flexible circuit of an end effector according to the disclosed technology; Figure 6 It shows Figures 6A to 6E A detailed view relative to a schematic diagram of the layout of the diagram; Figure 6A This is a schematic diagram showing a detailed view of the proximal portion of a first flexible circuit according to the disclosed technology; Figure 6B It is a schematic diagram showing a detailed view of the middle lateral portion of a first flexible circuit according to the disclosed technology; Figure 6C It is a schematic diagram showing a detailed view of the distal lateral portion of a first flexible circuit according to the disclosed technology; Figure 6D It is a schematic diagram showing a detailed view of the distal central portion of a first flexible circuit according to the disclosed technology; Figure 6E It is a schematic diagram showing a detailed view of the proximal central portion of a first flexible circuit according to the disclosed technology; Figure 7 This is a schematic diagram showing a detailed entity of an alternative first flexible circuit according to the disclosed technology; Figure 8 This is a schematic diagram illustrating a medical probe assembly according to the disclosed technology; and Figure 9 It is a flowchart of a manufacturing method based on the disclosed technology. Detailed Implementation

[0013] The following detailed description should be read in conjunction with the accompanying drawings, in which the same elements are labeled the same in different figures. The drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The principles of the invention are illustrated by way of example rather than limitation. This description will clearly enable those skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including those currently believed to be the best mode for carrying out the invention.

[0014] As used herein, the terms “about,” “approximately,” or “roughly” for any numerical value or range indicate suitable dimensional tolerances that allow a collection of parts or components to achieve the intended purpose as described herein. More specifically, “about,” “approximately,” or “roughly” may refer to a range of values ​​±20% of the enumerated values; for example, “about 90%” may refer to a range of values ​​from 71% to 110%. For a further example, “roughly parallel” may refer to a range of values ​​parallel (i.e., at a 0-degree angle relative to each other) ±20 degrees. Furthermore, as used herein, the terms “patient,” “recipient,” “user,” and “examinee” refer to any human or animal examinee and are not intended to limit the system or method to human use, but the use of the subject matter in human patients represents a preferred embodiment. Similarly, the term “proximal” refers to a position closer to the operator or physician, while “distal” refers to a position further away from the operator or physician.

[0015] As discussed herein, the vascular system of the “patient,” “recipient,” “user,” and “subject” can be that of a human or any animal. It should be understood that the animal can be any applicable type, including but not limited to mammals, veterinary animals, livestock, or pets. For example, the animal can be a laboratory animal specifically selected to possess certain characteristics similar to humans (e.g., rats, dogs, pigs, monkeys, etc.). It should be understood that the subject can be, for example, any applicable human patient.

[0016] As discussed herein, “operator” may include physicians, surgeons, technicians, scientists, or any other individual or delivery device associated with the delivery of a multi-electrode catheter for the treatment of drug-resistant atrial fibrillation to a patient.

[0017] This disclosure relates to systems, methods, uses, and devices for mapping and ablating cardiac tissue to treat arrhythmias. Ablation energy is typically delivered to the cardiac tissue via a distal portion of a catheter that delivers the energy along the tissue to be ablated. Some example catheters include a three-dimensional structure at their distal portion and are configured to apply ablation energy from various electrodes positioned on the three-dimensional structure. Fluoroscopy can be used to visualize ablation procedures incorporating such example catheters.

[0018] The use of thermal techniques such as radiofrequency (RF) energy and cryoablation to correct faulty heart tissue ablation is a well-known procedure. Typically, for successful ablation using thermal techniques, cardiac electrode potentials need to be measured at various locations in the myocardium. Furthermore, temperature measurements during ablation provide data that enable the ablation to be effective. Generally, for ablation procedures using thermal ablation, electrode potentials and temperatures are measured before, during, and after the actual ablation. RF methods can carry risks that may include tissue charring, burns, vapor bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistula. Cryoablation is an alternative to RF ablation, reducing some of the thermal risks associated with it. However, manipulating cryoablation devices and selectively applying cryoablation is generally more challenging than with RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electroablation devices.

[0019] This disclosure may include electrodes configured for RF ablation, cryoablation, and / or irreversible electroporation (IRE). Throughout this disclosure, IRE is interchangeably referred to as pulsed electric field (PEF) ablation and pulsed field ablation (PFA). IRE, as discussed in this disclosure, is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. To perform ablation using IRE / PEF, a biphasic voltage pulse is applied to disrupt the cellular structures of the myocardium. The biphasic pulse is non-sinusoidal and can be tuned to target cells based on the electrophysiology of the cells. In contrast, to perform ablation using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, indiscriminately heating all cells in the treatment area. Therefore, IRE has the ability to avoid adjacent heat-sensitive structures or tissues, which is beneficial in reducing potential complications known to be affected by ablation or dissociation modes. In addition to or alternatively, monophasic pulses may be used.

[0020] refer to Figure 1 This document illustrates an example catheter-based electrophysiological mapping and ablation system 10. System 10 includes multiple catheters inserted by a physician 24 through the skin into the chambers or vascular structures of the heart 12 via the patient's vascular system 23. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location within the heart 12. Multiple catheters can then be inserted into the delivery sheath catheter to reach that desired location. These multiple catheters may include catheters specifically for sensing intracardiac electrogram (IEGM) signals, catheters specifically for ablation, and / or catheters specifically for both sensing and ablation. An example catheter / medical probe 14 configured for sensing IEMM is illustrated herein. The physician 24 contacts the catheter shaft, having the distal end 28 of catheter 14 (e.g., a multilayer end effector 100), against the heart wall for sensing a target site within the heart 12. For ablation, the physician 24 similarly guides the distal end of the ablation catheter to the target site for ablation.

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

[0022] A magnetic-based position sensor can operate in conjunction with a positioning pad 25, which includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predefined workspace. The real-time position of the end effector 100 of the conduit 14 can be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor. Details of the magnetic-based position sensing technology are described in U.S. Patents 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, each of which is incorporated herein by reference.

[0023] System 10 includes one or more electrode patches 38 positioned to contact the skin of patient 23 to establish a position reference for impedance-based tracking of positioning pad 25 and electrode 102. For impedance-based tracking, current is directed toward electrode 102 and sensed at the electrode skin patch 38, allowing triangulation of the position of each electrode via the electrode patch 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.

[0024] Recorder 11 displays an electrogram 21 captured using surface ECG electrodes 18 and an intracardiac electrogram (IEGM) captured using electrodes 102 using catheter 14. Recorder 11 may include pacing capability for pacing rhythms and / or may be electrically connected to a separate pacemaker.

[0025] System 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more of electrodes 160A, 160B at an end actuator 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 combinations thereof.

[0026] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiological equipment, a power supply, and a workstation 55 for operating the system 10. The electrophysiological 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 has processing capabilities for real-time calculation of catheter position and for performing ECG calculations.

[0027] Workstation 55 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and user interaction capabilities. Workstation 55 may provide several functions, optionally including: (1) three-dimensional (3D) modeling of the endocardial anatomy and rendering the model or anatomical mapping 20 for display on display device 27; (2) displaying on display device 27, in the form of representative visual markers or images superimposed on the rendered anatomical mapping 20, an activation sequence (or other data) compiled from the recorded electrogram 21; (3) displaying the real-time position and orientation of multiple catheters within the cardiac chambers; and (4) displaying on display device 27 sites of interest, such as those where ablation energy has been applied. A commercial product embodying the elements of system 10 could be CARTO. ™ 3 System was purchased from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0028] Figures 2A to 6E Various views are provided of one or more portions of an end effector 100 (the term "end effector" is used herein synonymously with the term "distal end") configured for insertion into a patient's internal body cavity. Specifically, Figure 2A An exploded view of the first end effector 100 is shown, in which its components (it should be noted that some components, such as ring 146, are depicted for illustrative purposes and are not necessarily located in the actual components) are shown. Figure 2A The area depicted extends along the longitudinal axis 60 and is vertically decomposed along the vertical axis 62 (which is orthogonal to the longitudinal axis 60). Figure 3AA portion of the flexible circuitry 150 of the end effector 100 is shown. Figure 3B It shows along Figure 3A A cross-sectional view of the flexible circuit 150 cut from line 3B-3B in the diagram. Figure 4 A flexible circuit 150 is shown, which includes one or more position sensing loops 140. Figure 5 A view of another opposing flexible circuit 110 of the end effector 100 is shown, and Figures 6A to 6E This is a detailed view of the flexible circuit 150. In this example, the opposite flexible circuit 110 is designed identically, except for the configuration of the position sensing loop 140, and therefore, any description of the first flexible circuit 150 accurately describes the configuration of the second flexible circuit 110, and vice versa, unless otherwise specified.

[0029] End effector 100 is connected to elongated shaft 230 ( Figure 8 The proximal end of (also known as a tubular member) Figure 2A The upper right side extends along the longitudinal axis 60 to the distal end ( Figure 2A The lower left side of the insulating material 130 includes components adjacent to and / or disposed within the insulating material. 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 examples, the term "flexible circuit" includes thin-film circuits, flexible printed circuit boards, and thin-film deposition on a substrate via photolithography and etching processes, such as polyimide, copper, LCP, nitinol substrate, thermoplastic polyurethane (TPU), silicone, thermosetting resin, or other polymer substrates. In some examples, the flexible circuit described herein may be made primarily of polyimide. In other examples, it may be made alone or in combination of any of biocompatible polyimide, glass-reinforced epoxy laminate, copper, or graphene. In some examples, the electrode 160A described herein may include at least one mapping electrode and / or at least one ablation electrode, and may be configured to detect electrophysiological signals or transfer ablation energy AC or DC from an energy generator to tissue according to various ablation methods previously described (e.g., RF, IRE, etc.). The structure of the first flexible circuit 110 (and similarly, the second flexible circuit 150) is described below regarding... Figures 3A to 6E Let's discuss this in more detail.

[0030] The end effector 100 may also include a frame 120 adjacent to or within the insulating material 130. In examples where the distal end 28 includes the frame 120, the frame 120 may be directly disposed on the first flexible circuit 150 (or both the first flexible circuit 150 and the second flexible circuit 110), wherein there is no insulating material 130 or very little insulating material between them. In other examples, an insulating layer of the insulating material 130 may space the frame 120A from the flexible circuits 110, 150. In some examples, the frame 120 is disposed 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 frame 120. In some examples, the frame 120 is symmetrical with respect to the longitudinal axis 60. In some examples, the frame 120 is formed of a flexible elastic material. As an example, the frame may be formed of a shape memory alloy, such as nickel-titanium (also known as nitinol), cobalt-chromium, stainless steel, and / or other alloys exhibiting pseudoelastic and / or hyperelastic properties. The frame 120 can be formed from planar or cylindrical raw materials using any suitable method. For example, the frame 120 can be formed by cutting, laser cutting, stamping, etc.

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

[0032] As a non-limiting example, one or both of the flexible circuits 110 and 150 may be configured such that: (1) on the outer surfaces 131A and 131B of the insulating material 130 (e.g., as shown in the image) Figure 2C (as seen in the image), (2) suspended within the insulating material 130 and laid approximately flat (e.g., as shown in the image). Figure 2B or Figure 2D (as seen in the image), or (3) suspended on and / or inside the insulating material 130 at different distances from the frame 120 (e.g., one or more portions of the flexible circuits 110, 150 may be positioned at one height (relative to the vertical axis 62) from the frame 120, and other portions of the flexible circuits 110, 150 may be positioned at another different height (relative to the vertical axis) from the frame 120).

[0033] In other words, regarding the third example mentioned in the previous paragraph, the flexible circuits 110 and 150 do not necessarily need to be laid flat and / or in a plane parallel to the plane of the frame 120 (i.e., they may not be parallel to the frame 120). For example, some portions of the flexible circuits 110 and 150 may be closer to the outer surfaces 131A and 131B of the insulating material 130 (e.g., a portion of the flexible circuits 110 and 150 has a similar shape to...). Figure 2B The configuration depicted is further away from frame 120, while other parts may be closer to frame 120 (e.g., a portion of flexible circuits 110, 150 has a similar configuration). Figure 2D The configuration depicted is closer to the frame.

[0034] The insulating material 130 may abut the contact surfaces of the electrodes 160 such that only at least a portion of the contact surfaces of the plurality of electrodes 160 are exposed to the surrounding environment. As used herein, “surrounding environment” refers to the external environment, such as an organ in which the first end effector 100 is deployed or an operating room prior to the deployment of the first end effector in a biological organ. The insulating material 130 at least partially encapsulates and / or spaces the different layers of the end effector 100 (e.g., flexible circuits 110, 150 and frame 120) along a vertical axis 62.

[0035] It should be noted that not all electrodes 160 on the flexible circuits 110, 150 described herein need to be exposed through the insulating material 130, as these unexposed electrodes can be used to sense far-field signals for noise reduction of proximity-tissue contact electrodes. Similarly, for an end effector with a reference electrode that contacts only blood and not tissue, far-field signals including noise or artifacts can be reduced or eliminated.

[0036] The insulating material 130 may include one or more sheets fused together near the frame 120 to form a single, continuous, generally planar insulating block 130. The insulating material 130 also serves to enhance the non-invasiveness of the end effector tip 100 and protect the subject from injury by sharp edges. The insulating material 130 may comprise a polymer. The insulating material 130 may be thermally formed around at least a portion of the first flexible circuit 150, the second flexible circuit 110, and the frame 120. The polymer may comprise TPU or other thermally formed or molded materials that are inherently suitable for the thermal forming process.

[0037] Furthermore, although the insulating material 130 is shown as flat in these figures, the insulating material 130 may be shaped, toothed, ribbed, ridged, concave, convex, or otherwise configured such that the overall profile of the insulating material 130 produces the physical and / or mechanical properties required by the distal end 28 / end actuator 100 mentioned above, such as rigidity and flexural strength along multiple axes.

[0038] The flexible substrate of each flexible circuit 110, 150 (e.g., Figure 3B The flexible substrate 150-1 (as seen herein) comprises a biocompatible material and has a first side and a second side. In some examples, the flexible substrate is formed entirely or almost entirely of a biocompatible material. Electrodes 160 are disposed on the surface of the flexible substrate, such as the first surface 150A of the first flexible circuit 150. In some examples, electrodes 160 are disposed only on one side of the substrate 150-1, wherein electrical interconnects / traces 162 for connecting to and supplying power thereto are wired on the opposite surface 150B of the flexible circuit 150. See, for example, […]. Figure 3B ,as well as Figure 3A The exemplary trace 162 is depicted as a dashed line. In other words, the electrode 160 is directed away from the frame 120, while the trace 162 is directed towards the frame 120.

[0039] For details, please refer to the following: Figure 4 and Figure 5 Each flexible circuit 110, 150 includes multiple electrodes 160, bases 111, 151 (the base includes pad areas disposed at its proximal ends (respectively) Figure 5 and Figure 4 The bottom portion), a plurality of sharp teeth 112-116, 152-156 extending from the base 111, 151, a plurality of gaps 119A-H, 159A-H defined between the sharp teeth 112-116, 152-156, and connecting the distal sections 118, 158.

[0040] For details, please refer to the following: Figure 4 The first flexible circuit 150 includes a flexible substrate 150-1, a central fang 154 extending along a longitudinal axis 60, and offset fangs 152, 153, 155, and 156 offset from the longitudinal axis. More specifically, the offset fangs 152, 153, 155, and 156 extend from a base 151 away from the longitudinal axis 60 and then extend generally along / parallel to the longitudinal axis. A plurality of electrodes 160 are disposed on each fang 152-156. The electrodes 160 may be disposed along the fangs 152-156 such that they are aligned along the longitudinal axis 60 relative to the electrodes 160 on adjacent fangs 152-156. In other examples, the electrodes 160 may be misaligned (i.e., staggered) relative to the electrodes 160 on adjacent fangs in a direction transverse to the longitudinal axis 60, such that they are arranged in an alternating alignment pattern from fang to fang.

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

[0042] Teeth 152-156, connecting sections 157A, 157B, and connecting distal section 158 together define corresponding gaps 159A-H. Specifically, gaps 159A-H (i.e., areas not covered by any material) are defined between the corresponding teeth 152-156 of the flexible circuit 150. This reduction in material can help facilitate the collapse of the end effector 100 into the sheath and / or insertion tool.

[0043] Alternatively, the serrations include connecting external sections 152A, 156A, which do not include electrode 160. Instead, these sections help define the shape of the end effector 100 and provide reinforcement / protection for the sections of the flexible circuit 150 carrying the traces 162 and / or electrode 160.

[0044] Continue referring to Figure 2 to... Figure 4 and Figures 6A to 6E Multiple sensing rings 140 can be provided, which are disposed on the flexible substrate 150-1 of the first flexible circuit 150. Specifically, and as shown in... Figure 3B As illustrated, electrode 160 and position sensing ring 140 (see coil 142 of position sensing ring 140) are disposed on the same first surface 150A of flexible substrate 150-1.

[0045] Each sensing ring 140 serves as a position sensor (and is therefore also referred to herein as a position sensing ring, though it should be noted that the ring may have more functions than simply providing position information). This position sensor has one or more coils (each coil corresponding to a single turn of the corresponding position sensing ring), each coil having a trace that, when subjected to a magnetic field, respectively senses a current indicating the position and / or shape of the end effector 100. Each coil includes a surface area defined by the area enclosed by the corresponding coil and corresponds to a specific region of the flexible circuits 110, 150. By providing multiple coils in the sensing ring 140, the total surface area covered by the ring 140 can be increased. Furthermore, by providing the sensing ring 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 ring 140 requires its own flexible circuit layer), which minimizes strain on these traces 162 and reduces the complexity of the end effector 100.

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

[0047] like Figure 4 As seen, the first position sensing ring 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 tooth 152 and the lateral portion of the distal connecting segment 158, while the second segment 140A-2 is routed along the third tooth 154 and the first intermediate connecting segment 157A. These segments 140A-1 and 140A-2 converge on the distal portion 151A of the base 151 and on the second tooth 153 (which is offset from the longitudinal axis 60).

[0048] In addition to the above, in this example, the first position sensing ring 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, other numbers of coils 142 may be used without departing from the spirit and scope of this disclosure (as discussed in more detail below). Figures 6A to 6EA portion of the flexible circuit 150 is depicted, illustrating an exemplary wiring configuration for coils 142A-142C. (See attached image.) Figure 6A As seen, a first position sensing ring 140A extends from a first distal end 141A (which may include pad 141A) to a second distal end 141B (which may include pad 141B), both of which are close to each other on the base 151 of the flexible circuit 150.

[0049] To prevent short circuits, coils 142A-142C are wired to avoid contact with each other. The position sensing ring 140A has a spiral shape, with a first pad 141A disposed on the outer portion of the spiral shape on the first surface 150A of the flexible substrate 150-1, and a second pad 141B disposed on the inner portion of the spiral shape on the first surface 150A of the flexible substrate 150-1. See also Figures 6A to 6E For reference. For example, as in Figure 6B As seen, each coil in coils 142A-142C is also wired such that they pass around electrode 160 without contacting the electrode (in order to also prevent electrical short circuits).

[0050] This wiring can be used in various configurations without departing from the spirit and scope of this disclosure. For example, such as Figure 6B As seen, the first coil 142A and the second coil 142B pass to the left across electrode 160 on the first tooth 152, while the third coil 142C passes to the right across electrode 160 on the first tooth 152. Conversely, on the third tooth 154, the three coils 142A-142C pass across electrode 160 on the same side (this prevents intersections with the second position sensing ring 140B, which will be discussed in more detail below). Figure 6C As seen, around another electrode 160 (e.g., the uppermost electrode on the second tooth 153), the first coil 142A can pass through one side, while the second coil 142B and the third coil 142C pass through electrode 160 on the same side.

[0051] like Figure 4 As seen, the second position sensing ring 140B is symmetrical to the first position sensing ring 140 about 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 tooth 156 and the lateral portion of the distal connecting segment 158, while the second segment 140B-2 is routed along the third tooth 154 (the second segment 140A-2, which is generally parallel to the first position sensing ring 140A) and the second intermediate connecting segment 157B. These segments 140B-1 and 140B-2 converge on the distal portion 151A of the base 151 and on the fourth tooth 155 (which is offset from the longitudinal axis 60).

[0052] In addition to the above, and similar to the first position sensing ring 140A, the second position sensing ring 140B 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, other numbers of coils 144 may be used without departing from the spirit and scope of this disclosure (as discussed in more detail below). Figure 6A As seen, the second position sensing ring 140A extends from the first distal end 141D (which may include pad 141D) to the second distal end 141C (which may include pad 141C), both of which are close to each other on the base 151 of the flexible circuit 150.

[0053] To prevent short circuits, like the first position sensing ring 140A, coils 144A-144C are wired to avoid contact with each other. This results in the second position sensing ring 140B having a spiral shape, wherein a first pad 141D is disposed on the outer portion of the spiral shape on the first surface 150A of the flexible substrate 150-1, and a second pad 141C is disposed on the inner portion of the spiral shape on the first surface 150A of the flexible substrate 150-1. See also Figures 6A to 6E For reference. For example, as in Figure 6B As seen, each of the coils 142A-142C is also wired such that they pass around electrode 160 along their respective paths without contacting the electrode (in order to also prevent electrical short circuits). It should be noted that the second position sensing ring 140B may take a path that is substantially mirrored to that of the first position sensing ring 140A, or a different path, depending on the design requirements. As stated above, such wiring can be employed in various configurations without departing from the spirit and scope of this disclosure. Figure 6D As can be seen in detail, the first position sensing ring 140A and the second position sensing ring 140B converge together on the third tooth 154 along the connecting section 157.

[0054] Now go to Figure 5 The second flexible circuit 110 shares the same design concept as the first flexible circuit 150, but the position sensing loop 140 has a different configuration. See details... Figure 5The second flexible circuit 110 includes a flexible substrate 110-1, a central fang 114 extending along a longitudinal axis 60, and offset fangs 112, 113, 115, and 116 offset from the longitudinal axis 60. More specifically, the offset fangs 112, 113, 115, and 116 extend from a base 111 away from the longitudinal axis 60 and then extend generally along / parallel to the longitudinal axis. A plurality of electrodes 160 are disposed on each fang 112-116. The electrodes 160 may be disposed along the fangs 112-116 such that they are aligned along the longitudinal axis 60 relative to the electrodes 160 on adjacent fangs 112-116. In other examples, the electrodes 160 may be misaligned (i.e., staggered) relative to the electrodes 160 on adjacent fangs in a direction transverse to the longitudinal axis 60, such that they are arranged in an alternating alignment pattern from fang to fang.

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

[0056] The serrations 112-116, the connecting section 117, and the connecting distal section 118 together define corresponding gaps 119A-H. This reduction in material can help facilitate the collapse of the end effector 100 into the sheath and / or insertion tool.

[0057] Additionally, the cusps 112-116 include connecting external sections ( Figure 5 (The lower left and lower right unmarked areas in the diagram) These external connection sections do not include the electrode 160. Instead, these sections help define the shape of the end effector 100 and provide reinforcement / protection for the various sections of the flexible circuit 110 that carries the electrical traces 162 and / or the electrode 160.

[0058] It should be noted that, as with the previously described flexible circuit 150, not all electrodes 160 on the second flexible circuit 110 described herein need to be exposed through the insulating material 130, as these unexposed electrodes can be used to sense far-field signals for noise reduction of proximity-tissue-contact electrodes. Similarly, for an end effector with a reference electrode that is in contact with blood but not with tissue, far-field signals including noise or artifacts can be reduced or eliminated.

[0059] Continue to refer to Figure 5 A single position sensing ring 140C can be provided, which is disposed on the flexible substrate 110-1 of the second flexible circuit 110. Specifically, and as... Figure 3B As illustrated in the depiction of the first flexible substrate 150-1, the electrode 160 and the position sensing ring 140 (see coil 142 of the position sensing ring 140) are disposed on the same surface of the flexible substrate.

[0060] The position sensing ring 140C serves as a position sensor having one or more coils (each coil corresponding to a single turn of the corresponding position sensing ring) with traces that, when subjected to a magnetic field, each induce a current indicating the position and / or shape of the end effector 100. Each coil includes a surface area defined by the area enclosed by the corresponding coil and corresponds to a specific region of the flexible circuitry 150. By providing multiple coils in the position sensing ring 140, the total surface area covered by the ring 140 can be increased. Furthermore, by providing the position sensing ring 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 ring 140 requires its own flexible circuitry layer), which minimizes strain on these traces 162 and reduces the complexity of the end effector 100.

[0061] In an example of the second flexible circuit 110, as described above, there is a single position sensing ring 140C comprising one or more coils 146A-146C. The first position sensing ring 140A and the second position sensing ring 140B each comprise one or more coils 142. The first position sensing ring 140A typically extends along a base 151, a first tooth 152, a connecting distal section 158, a second tooth 153, a first intermediate connecting section 157A, and a third tooth 154. The second position sensing ring 140B typically extends along a base 151, a fifth tooth 156, a connecting distal section 158, a fourth tooth 155, a second intermediate connecting section 157B, and a third tooth 154.

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

[0063] In addition to the above, in this example, the position sensing ring 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 region of the flexible circuit 110. However, other numbers of coils 146 may be used without departing from the spirit and scope of this disclosure (discussed in more detail below). Although the specific wiring of the respective coils 146A-146C is not explicitly depicted, those skilled in the art will understand that the position sensing ring 140C of the second flexible circuit 110 may employ the same wiring principles and the same design concepts as those previously described, such as being in a spiral shape (which connects to pads 141E and 141F at its distal ends).

[0064] Briefly switch to Figure 7 Furthermore, as stated above, the currently disclosed technology can employ a different number of coils without departing from the spirit and scope of this disclosure. For example, an alternative flexible circuit 150' may include a first position sensing ring and a second position sensing ring, each of which includes two coils 142A', 142B' and 144A', 144B', instead of three coils.

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

[0066] In addition to the examples above, and referring to Figure 9A method 900 for manufacturing an end effector for a medical device may include the following steps. The method includes forming a plurality of electrodes 902 on a first surface of a plurality of teeth of a flexible circuit, the plurality of teeth extending generally parallel to a longitudinal axis. The first surface is common across the teeth and is the surface of the flexible substrate discussed above. The method includes forming a position sensing ring 904 on the first surface. The position sensing ring forms one or more coils configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field. The position sensing ring includes two segments (i) extending along corresponding teeth of the plurality of teeth, and (ii) converging toward each other on teeth of the plurality of teeth disposed on or offset from the longitudinal axis. The position sensing ring is wired such that it does not contact the electrodes. The position sensing ring is wired in a helical shape. The method also includes forming electrical traces 906 on a second surface of the flexible circuit. As described above, by forming the position sensing ring on the same flexible circuit as the electrodes, the total number of layers of flexible circuitry in the end effector 100 can be reduced.

[0067] The disclosed technology described herein can be further understood in accordance with the following terms: Clause 1. A flexible circuit for an end effector of a medical probe, the flexible circuit comprising: a flexible substrate defining a plurality of teeth extending along a longitudinal axis; a plurality of electrodes disposed on each of the plurality of teeth; and a first sensing ring disposed on the flexible substrate, the first position sensing ring forming one or more coils configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field, and the first position sensing ring including two segments disposed on corresponding teeth of the plurality of teeth, the two segments extending generally parallel to the longitudinal axis and converging toward each other on the teeth of the plurality of teeth disposed on the longitudinal axis.

[0068] Clause 2. The flexible circuit according to Clause 1, wherein the flexible substrate includes a first surface and a second surface, and both the electrode and the one or more sensing rings are disposed on the first surface.

[0069] Clause 3. The flexible circuit according to Clause 2 further includes one or more electrical interconnects electrically connected to the electrode and disposed along the second surface.

[0070] Clause 4. The flexible circuit according to any one of Clauses 2 to 3, wherein the one or more coils are wired along the path of the one or more coils and around each of the plurality of electrodes along the flexible substrate.

[0071] Clause 5. The flexible circuit according to any one of Clauses 1 to 4, wherein the at least one coil comprises a first coil extending around a region of the flexible substrate and a second coil extending around the region of the flexible substrate.

[0072] Clause 6. The flexible circuit according to Clause 5, wherein the at least one coil includes a third coil extending around the region of the flexible substrate.

[0073] Clause 7. The flexible circuit according to Clause 6, wherein the first coil, the second coil and the third coil are wired along the flexible substrate such that the first coil and the second coil pass around the electrode on a first side of the electrode, and the third coil passes around the electrode on an opposite second side of the electrode.

[0074] Clause 8. The flexible circuit according to Clause 6, wherein the first coil, the second coil, and the third coil are wired 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.

[0075] Clause 9. The flexible circuit according to any one of Clauses 1 to 8, wherein each position sensing ring extends from a first distal end to a second distal end.

[0076] Clause 10. The flexible circuit according to Clause 9, wherein the first distal end and the second distal end are disposed at the proximal end of the flexible circuit.

[0077] Clause 11. The flexible circuit according to any one of Clauses 9 to 10, wherein the first distal end includes a first pad and the second distal end includes a second pad.

[0078] Clause 12. The flexible circuit according to Clause 11, wherein the flexible substrate includes a base, and the first pad and the second pad are disposed on the base.

[0079] Clause 13. The flexible circuit according to any one of Clauses 11 to 12, each position sensing ring having a helical shape defining the one or more coils, wherein a first pad is disposed on an outer portion of the helical shape on a first surface of the flexible substrate, and a second pad is disposed on an inner portion of the helical shape on the first surface of the flexible substrate.

[0080] Clause 14. The flexible circuit according to any one of Clauses 9 to 12, wherein each position sensing ring has a helical shape defining the one or more coils.

[0081] Clause 15. The flexible circuit described in Clause 14, wherein each coil corresponds to a single turn of the sensing loop at the corresponding position.

[0082] Clause 16. A flexible circuit according to any one of Clauses 1 to 15, the flexible substrate comprising a base, a first intermediate connection segment, a second intermediate connection segment, and a connection distal segment, and the plurality of teeth comprising: a first tooth extending from the base along the longitudinal axis; a second tooth extending from the base along the longitudinal axis; a third tooth extending from the base along the longitudinal axis, the teeth of the two segments corresponding to the third tooth at their converging points; a fourth tooth extending from the base along the longitudinal axis; and a fifth tooth extending from the base along the longitudinal axis, the first intermediate connection segment connecting the second tooth and the third tooth; the second intermediate connection segment connecting the third tooth and the fourth tooth, and the connection distal segment connecting the distal ends of the first tooth, the second tooth, the third tooth, the fourth tooth, and the fifth tooth.

[0083] Clause 17. The flexible circuit according to Clause 16, wherein the first tooth, the second tooth, the third tooth, the fourth tooth, the fifth tooth, the first intermediate connection segment, and the second intermediate connection segment define corresponding gaps between them.

[0084] Clause 18. The flexible circuit according to any one of Clauses 16 to 17, wherein the first position sensing ring extends along the base, the second tooth, the first intermediate connection segment, the third tooth, the second intermediate connection segment, and the fourth tooth, wherein the two segments converge toward each other on the third tooth and the base.

[0085] Clause 19. The flexible circuit according to any one of Clauses 1 to 18, each coil includes a surface area defined by the area surrounding the respective coil, each area corresponding to a region of the flexible circuit.

[0086] Clause 20. The flexible circuit according to any one of Clauses 1 to 19, wherein the current indicates the shape of a portion of the flexible circuit.

[0087] Clause 21. A flexible circuit for an end effector of a medical probe, the flexible circuit comprising: a flexible substrate defining a plurality of teeth extending along a longitudinal axis; a plurality of electrodes disposed on each of the plurality of teeth; and a first sensing ring and a second sensing ring disposed on the flexible substrate, each of the first and second sensing rings forming one or more coils configured to generate a current indicating the position of the one or more coils when subjected to a magnetic field, the first sensing ring comprising two segments disposed on corresponding teeth of the plurality of teeth, the two segments extending along the longitudinal axis and converging toward each other on a tooth of the plurality of teeth offset from the longitudinal axis, and the second sensing ring comprising two segments disposed on corresponding teeth of the plurality of teeth, the two segments extending along the longitudinal axis and converging toward each other on another tooth of the plurality of teeth offset from the longitudinal axis.

[0088] Clause 22. The flexible circuit according to Clause 21, wherein the flexible substrate includes a first surface and a second surface, and both the electrode and the one or more sensing rings are disposed on the first surface.

[0089] Clause 23. The flexible circuit according to Clause 22, the flexible circuit further comprising one or more electrical interconnects electrically connected to the electrode and disposed along the second surface.

[0090] Clause 24. The flexible circuit according to any one of Clauses 22 to 23, wherein the one or more coils are wired to pass along the flexible substrate around the electrodes.

[0091] Clause 25. The flexible circuit according to any one of Clauses 21 to 24, wherein the at least one coil comprises a first coil extending around a region of the flexible substrate and a second coil extending around the region of the flexible substrate.

[0092] Clause 26. The flexible circuit according to Clause 25, wherein the at least one coil includes a third coil extending around the region of the flexible substrate.

[0093] Clause 27. The flexible circuit according to Clause 26, wherein the first coil, the second coil, and the third coil are wired along the flexible substrate such that the first coil and the second coil pass around the first electrode on a first side of the first electrode among the plurality of electrodes, and the third coil passes around the first electrode on a second side opposite to the first electrode.

[0094] Clause 28. The flexible circuit according to Clause 26, wherein the first coil, the second coil, and the third coil are wired along the flexible substrate such that the first coil, the second coil, and the third coil pass around the first electrode on the same side of the first electrode among the plurality of electrodes.

[0095] Clause 29. The flexible circuit according to any one of Clauses 21 to 28, wherein each position sensing loop extends from a first distal end to a second distal end.

[0096] Clause 30. The flexible circuit according to Clause 29, wherein the first distal end and the second distal end are disposed at the proximal end of the flexible circuit.

[0097] Clause 31. The flexible circuit according to any one of Clauses 29 to 30, wherein the first distal end includes a first pad and the second distal end includes a second pad.

[0098] Clause 32. The flexible circuit according to Clause 31, wherein the flexible substrate includes a base, and the first pad and the second pad are disposed on the base.

[0099] Clause 33. The flexible circuit according to any one of Clauses 31 to 32, each position sensing ring having a helical shape defining the one or more coils, wherein a first pad is disposed on an outer portion of the helical shape on a first surface of the flexible substrate, and a second pad is disposed on an inner portion of the helical shape on the first surface of the flexible substrate.

[0100] Clause 34. The flexible circuit according to any one of Clauses 29 to 32, wherein each position sensing ring has a helical shape defining the one or more coils.

[0101] Clause 35. The flexible circuit described in Clause 34, wherein each coil corresponds to a single turn of the sensing loop at the corresponding position.

[0102] Clause 36. The flexible circuit according to any one of Clauses 21 to 35, the flexible substrate comprising a base, a first intermediate connection segment, a second intermediate connection segment, and a connection distal segment, and the plurality of teeth comprising: a first tooth extending from the base along the longitudinal axis; a second tooth extending from the base along the longitudinal axis, wherein the teeth of the two segments of the first position sensing ring converging toward each other correspond to the second tooth; a third tooth extending from the base along the longitudinal axis; a fourth A fourth tooth extends from the base along the longitudinal axis, and the other tooth at the point where the two segments of the second sensing ring converge corresponds to the fourth tooth; and a fifth tooth extends from the base along the longitudinal axis, a first intermediate connecting segment connecting the second tooth and the third tooth; a second intermediate connecting segment connecting the third tooth and the fourth tooth, and a connecting distal segment connecting the distal ends of the first tooth, the second tooth, the third tooth, the fourth tooth, and the fifth tooth.

[0103] Clause 37. The flexible circuit according to Clause 36, wherein the first tooth, the second tooth, the third tooth, the fourth tooth, the fifth tooth, the first intermediate connection segment, and the second intermediate connection segment define corresponding gaps between them.

[0104] Clause 38. The flexible circuit according to any one of Clauses 36 to 37, wherein the first position sensing ring extends along the base, the first tooth, the connecting distal section, the second tooth, the first intermediate connecting section, and the third tooth.

[0105] Clause 39. The flexible circuit according to any one of Clauses 36 to 38, wherein the second sensing ring extends along the base, the fifth tooth, the connecting distal section, the fourth tooth, the second intermediate connecting section, and the third tooth.

[0106] Clause 40. The flexible circuit according to any one of Clauses 21 to 39, each coil includes a surface area defined by the area surrounding the respective coil, each area corresponding to a region of the flexible circuit.

[0107] Clause 41. In any one of Clauses 21 to 40, the current indicates the shape of a portion of the flexible circuit.

[0108] Clause 42. An end effector for a medical probe, the end effector comprising: an insulating material; a frame disposed in the insulating material, the frame being generally planar along a longitudinal axis; and a first flexible circuit disposed in the insulating material such that the first flexible circuit is spaced apart from the frame along a vertical axis, the first flexible circuit comprising: a first flexible substrate defining a plurality of first teeth extending along the longitudinal axis; a plurality of first electrodes disposed on each of the plurality of first teeth; and a first sensing ring and a second sensing ring disposed on the first flexible substrate, the first sensing ring and the second sensing ring being disposed on the first flexible substrate, the first flexible circuit comprising: an insulating material; a frame disposed in the ... Each of the first sensing ring and the second sensing ring forms one or more coils, the one or more coils being configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field. The first position sensing ring includes two segments disposed on corresponding teeth of the plurality of first teeth, the two segments extending along the longitudinal axis and converging toward each other on a tooth of the plurality of first teeth offset from the longitudinal axis. The second sensing ring includes two segments disposed on corresponding teeth of the plurality of first teeth, the two segments extending along the longitudinal axis and converging toward each other on another tooth of the plurality of first teeth offset from the longitudinal axis.

[0109] Clause 43. The end effector according to Clause 42, wherein the first sensing ring extends on a first side of the first flexible circuit and the second sensing ring extends on a second side of the first flexible circuit, the second side position sensing ring being arranged substantially symmetrically about the longitudinal axis relative to the first side position sensing ring.

[0110] Clause 44. The end effector according to any one of Clauses 42 to 43 further comprises: a second flexible circuit disposed in the insulating material such that the second flexible circuit is spaced apart from the frame and the first flexible circuit along the vertical axis, the second flexible circuit comprising: a second flexible substrate defining a plurality of second teeth extending along the longitudinal axis; a plurality of second electrodes disposed on each of the plurality of second teeth; and a third sensing ring disposed on the second flexible substrate, the third position sensing ring forming one or more coils configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field, and the third position sensing ring comprising two segments disposed on corresponding teeth of the plurality of second teeth, the two segments extending generally parallel to the longitudinal axis and converging toward each other on a first tooth of the plurality of second teeth disposed on the longitudinal axis.

[0111] Clause 45. The end effector according to Clause 44, wherein the third position sensing ring is arranged substantially symmetrically about the longitudinal axis.

[0112] Clause 46. A method comprising: forming a plurality of electrodes on a first surface of a plurality of teeth of a flexible circuit, the plurality of teeth extending generally parallel to a longitudinal axis; and forming a position sensing ring on the first surface, the position sensing ring forming one or more coils configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field, the position sensing ring comprising two segments (i) extending along a respective tooth of the plurality of teeth, and (ii) converging toward each other on a tooth of the plurality of teeth disposed on or offset from the longitudinal axis.

[0113] Clause 47. The method according to Clause 46, forming the position sensing loop includes: wiring the position sensing loop such that the position sensing loop does not contact the electrode.

[0114] Clause 48. The method according to any one of Clauses 46 to 47, forming the position sensing ring, comprises: wiring the position sensing ring in a spiral shape.

[0115] Clause 49. The method according to any one of Clauses 46 to 48 further comprises: forming electrical traces on the second surface of the flexible circuit.

[0116] Clause 50. An end effector for a medical probe, the end effector comprising: an insulating material; a frame disposed in the insulating material, the frame being generally planar along a longitudinal axis; and a first flexible circuit disposed in or on the insulating material, the first flexible circuit comprising: a first flexible substrate defining a plurality of first teeth extending along the longitudinal axis; a plurality of first electrodes disposed on each of the plurality of first teeth; and a first sensing ring and a second sensing ring disposed on the first flexible substrate, the first sensing ring and the second sensing ring being generally planar along a longitudinal axis. Each of the two sensing rings forms one or more coils, the one or more coils being configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field. The first position sensing ring includes two segments disposed on corresponding teeth of the plurality of first teeth, the two segments extending along the longitudinal axis and converging toward each other on a tooth of the plurality of first teeth offset from the longitudinal axis. The second sensing ring includes two segments disposed on corresponding teeth of the plurality of first teeth, the two segments extending along the longitudinal axis and converging toward each other on another tooth of the plurality of first teeth offset from the longitudinal axis.

[0117] Clause 51. The end effector according to Clause 50, wherein the first flexible circuit is generally planar along the longitudinal axis.

[0118] Clause 52. The end effector according to Clause 51, wherein the first flexible circuit extends generally parallel to the frame.

[0119] Clause 53. The end effector according to any one of Clauses 50 to 51, wherein the first flexible circuit includes a first portion and a second portion along the longitudinal axis, the first portion being configured at a first distance from the frame along the vertical axis, and the second portion being configured at a second distance from the frame along the vertical axis, the second distance being different from the first distance.

[0120] The above embodiments are cited by way of example, and the technology disclosed in this invention is not limited to the specific examples shown and described above. Rather, the scope of the technology disclosed in this invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which will be apparent to those skilled in the art upon reading the above description, and which are not disclosed in the prior art.

Claims

1. A flexible circuit for an end effector of a medical probe, the flexible circuit comprising: A flexible substrate, the flexible substrate defining a plurality of sharp teeth extending along a longitudinal axis; Multiple electrodes, wherein the multiple electrodes are disposed on each of the multiple cusps; and A first sensing ring is disposed on the flexible substrate. The first sensing loop forms one or more coils, which are configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field. The first sensing ring includes two segments disposed on corresponding teeth of the plurality of teeth, the two segments extending generally parallel to the longitudinal axis and converging toward each other on the teeth of the plurality of teeth disposed on the longitudinal axis.

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

3. The flexible circuit of claim 2 further includes one or more electrical interconnects electrically connected to the plurality of electrodes and disposed along the second surface.

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

5. The flexible circuit of claim 1, wherein the one or more coils include 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 of claim 5, wherein the one or more coils include a third coil extending around the region of the flexible substrate.

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

8. The flexible circuit according to claim 1, wherein each position sensing ring 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 disposed at the proximal end of the flexible circuit.

10. The flexible circuit of claim 8, wherein the first distal end includes a first pad, and the second distal end includes a second pad.

11. The flexible circuit of claim 10, wherein each position sensing ring has a helical shape defining the one or more coils, wherein a first pad is disposed on an outer portion of the helical shape on a first surface of the flexible substrate, and a second pad is disposed on an inner portion of the helical shape on the first surface of the flexible substrate.

12. The flexible circuit of claim 8, wherein each position sensing ring has a helical shape defining the one or more coils.

13. The flexible circuit according to claim 1, wherein the flexible substrate comprises a base, a first intermediate connection section, a second intermediate connection section, and a connection distal section, and the plurality of teeth comprises: A first pointed tooth extends from the base along the longitudinal axis; A second pointed tooth extends from the base along the longitudinal axis; A third cusp, the third cusp extending from the base along the longitudinal axis, the cusp at the point where the two segments converge corresponds to the third cusp; A fourth cusp tooth extends from the base along the longitudinal axis; and The fifth tooth extends from the base along the longitudinal axis; The first intermediate connecting section connects the second tooth and the third tooth; The second intermediate connecting section connects the third tooth and the fourth tooth, and The connecting distal section connects the distal ends of the first tooth, the second tooth, the third tooth, the fourth tooth, and the fifth tooth.

14. The flexible circuit of claim 13, wherein the first sensing ring extends along the base, the second tooth, the first intermediate connection section, the third tooth, the second intermediate connection section, and the fourth tooth, wherein the two sections converge toward each other on the third tooth and the base.

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

16. A flexible circuit for an end effector of a medical probe, the flexible circuit comprising: A flexible substrate, the flexible substrate defining a plurality of sharp teeth extending along a longitudinal axis; Multiple electrodes, wherein the multiple electrodes are disposed on each of the multiple cusps; and A first sensing ring and a second sensing ring are disposed on the flexible substrate. Each of the first sensing loop and the second sensing loop forms one or more coils, the one or more coils being configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field. The first sensing ring includes two segments disposed on corresponding teeth of the plurality of teeth, the two segments extending along the longitudinal axis and converging toward each other on a tooth of the plurality of teeth that is offset from the longitudinal axis. The second sensing ring includes two segments disposed on corresponding teeth of the plurality of teeth, the two segments extending along the longitudinal axis and converging toward each other on another tooth of the plurality of teeth that is offset from the longitudinal axis.

17. The flexible circuit of claim 16, wherein the flexible substrate comprises a base, a first intermediate connection section, a second intermediate connection section, and a connection distal section, and the plurality of teeth comprises: A first pointed tooth extends from the base along the longitudinal axis; The second tooth extends from the base along the longitudinal axis, and the tooth at the point where the two segments of the first sensing ring converge corresponds to the second tooth; A third cusp tooth extends from the base along the longitudinal axis; A fourth tooth, which extends from the base along the longitudinal axis, and the other tooth at the point where the two segments of the second sensing ring converge corresponds to the fourth tooth; and The fifth tooth extends from the base along the longitudinal axis; The first intermediate connecting section connects the second tooth and the third tooth; The second intermediate connecting section connects the third tooth and the fourth tooth, and The connecting distal section connects the distal ends of the first tooth, the second tooth, the third tooth, the fourth tooth, and the fifth tooth.

18. The flexible circuit of claim 17, wherein the first sensing ring extends along the base, the first tooth, the distal connecting section, the second tooth, the first intermediate connecting section, and the third tooth.

19. The flexible circuit of claim 17, wherein the second sensing ring extends along the base, the fifth tooth, the connecting distal section, the fourth tooth, the second intermediate connecting section, and the third tooth.

20. An end effector for a medical probe, the end effector comprising: Insulating materials; A frame disposed within the insulating material, the frame being generally planar along a longitudinal axis; and A first flexible circuit is disposed in the insulating material such that it is spaced apart from the frame along a vertical axis. The first flexible circuit includes: A first flexible substrate, the first flexible substrate defining a plurality of first teeth extending along the longitudinal axis; A plurality of first electrodes, the plurality of first electrodes being disposed on each of the plurality of first fangs; and A first sensing ring and a second sensing ring are disposed on the first flexible substrate. Each of the first sensing loop and the second sensing loop forms one or more coils, the one or more coils being configured to generate a current indicating the position of the one or more coils when the one or more coils are subjected to a magnetic field. The first sensing ring includes two segments disposed on corresponding teeth of the plurality of first teeth, the two segments extending along the longitudinal axis and converging toward each other on a tooth of the plurality of first teeth that is offset from the longitudinal axis. The second sensing ring includes two segments disposed on corresponding teeth of the plurality of first teeth, the two segments extending along the longitudinal axis and converging toward each other on another tooth of the plurality of first teeth that is offset from the longitudinal axis.

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