Medical probe with slitted tube and electrode

Abstract

To provide a medical probe.SOLUTION: The disclosed technique includes a medical probe. The medical probe includes an elongated body, a flexible circuit and one or more electrodes. The elongated body extends along a longitudinal axis from a proximal end to a distal end, defines a lumen, and includes a tube and outer wall jacket. The tube extends along the longitudinal axis and includes slits that permit the elongated body to deflect relative to the longitudinal axis. The outer wall jacket surrounds the tube. The flexible circuit is disposed on the outer wall jacket. The one or more electrodes are disposed on the flexible circuit and are designed to be placed in contact with tissue of an organ.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 612,263, filed on December 19, 2023 (Attorney Docket No.: BIO6921USPSP1 - 253757.000447), the entire content of which is incorporated herein by reference as if fully set forth herein.

[0002] (Field of the Invention) The present 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

[0003] Cardiac arrhythmias, such as atrial fibrillation (AF), occur when regions of heart tissue conduct electrical signals abnormally to adjacent tissue. This disrupts the normal cardiac cycle and causes asynchronous rhythms. Some of the specific procedures available for treating arrhythmias include surgically destroying the source of the signals causing the arrhythmia and destroying the conduction pathways of such signals. By applying energy via a catheter to selectively ablate heart tissue, it is sometimes possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another.

[0004] Many current ablation approaches in the art utilize radiofrequency (RF) electrical energy to heat tissue. RF ablation can have certain risks associated with thermal heating that can lead to tissue carbonization, burning, steam pops, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas.

[0005] Cryoablation is an alternative approach to RF ablation that generally reduces the thermal risks associated with RF ablation. However, operating a cryoablation device and selectively applying cryoablation is generally more difficult compared to RF ablation, and thus cryoablation may not be feasible in certain anatomical shapes that can be reached by an electrical ablation device.

[0006] Some ablation approaches use irreversible electroporation (IRE) to ablate cardiac tissue using a non-thermal ablation method. IRE delivers high-voltage short pulses to tissue, causing irreversible permeabilization of cell membranes. Delivery of IRE energy to tissue using a multi-electrode probe has been previously proposed in the patent literature. Examples of systems and devices configured for IRE ablation are disclosed in U.S. Patent Application Publication Nos. 2021 / 0169550(A1), 2021 / 0169567(A1), 2021 / 0169568(A1), 2021 / 0161592(A1), 2021 / 0196372(A1), 2021 / 0177503(A1), and 2021 / 0186604(A1), each of which is incorporated herein by reference.

[0007] Typically, a catheter is formed from a number of components that require many complex assembly steps that are laborious and / or time-consuming. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0008] Accordingly, there is a need for a simplified medical probe design that addresses these problems. MEANS FOR SOLVING THE PROBLEM

[0009] According to the disclosed technology, a medical probe is provided that includes an elongated body and one or more electrodes. The elongated body extends along a longitudinal axis from a proximal end to a distal end and defines a lumen. The elongated body includes a tube, an outer wall jacket, and a flexible circuit. The tube extends along the longitudinal axis and includes a plurality of slits formed in the tube. The slits enable the elongated body to deflect with respect to the longitudinal axis. The outer wall jacket surrounds the tube. The flexible circuit is disposed on the outer wall jacket. The one or more electrodes are disposed on the flexible circuit and are configured to be placed in contact with the tissue of an organ.

[0010] According to the disclosed technology, a method of forming a medical probe is further provided. The method includes laser cutting a tube to a predetermined length. The method includes laser cutting a plurality of slits in the tube, the slits enabling the tube to deflect with respect to the longitudinal axis. The method includes covering the outer surface of the tube with an outer wall jacket. The method includes at least partially wrapping a flexible circuit around the outer wall jacket, the flexible circuit including one or more electrodes. The method includes heating a thermoplastic material on the probe flexible circuit and reflowing the thermoplastic material. The method includes laser drilling openings in the thermoplastic material to expose the surface of the one or more electrodes.

Brief Description of the Drawings

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[0012] The following detailed description should be read with reference to the drawings, and like elements in different drawings are given the same numbers. The drawings are not necessarily to scale and show selected examples and are not intended to limit the scope of the present disclosure. The detailed description is illustrative, not limiting, and is given by way of example to illustrate the principles of the disclosed technique. This description enables those skilled in the art to make and use the disclosed technique and describes some embodiments, adaptations, variations, alternatives, and uses of the disclosed technique, including what is currently considered to be the best mode for practicing the disclosed technique.

[0013] 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 to function for the intended purpose described herein. More specifically, "about" or "substantially" can refer to a range of values within ±20% of the recited value. For example, "about 90%" can refer to a range of values from 71% to 110%. Additionally, 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.

[0014] As contemplated 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. By way of example, the animal can be a laboratory 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.

[0015] As contemplated 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 in a subject.

[0016] As contemplated herein, the term "ablating" or "ablation", when referring to the devices and corresponding systems of the present disclosure, refers throughout the present disclosure to components and structural features configured to reduce or prevent the generation of irregular cardiac signals within cells by utilizing non-thermal energy such as irreversible electroporation (IRE), which is interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA) throughout the present disclosure. When referring to the devices and corresponding systems of the present disclosure, ablating or ablation is used throughout the present disclosure with reference to the non-thermal ablation of cardiac tissue in certain conditions, including but not limited to arrhythmias, atrial fibrillation ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablating" or "ablation" also includes known methods, devices, and systems for achieving various forms of physical tissue ablation, as would be understood by one of ordinary skill in the art.

[0017] As discussed herein, the terms "bipolar" and "unipolar," when used to refer to ablation schemes, describe different ablation schemes with respect to current paths and electric field distributions. "Bipolar" refers to an ablation scheme that utilizes a current path between two electrodes both placed at the treatment site. The current density and the electric flux density are typically approximately equal at each of the two electrodes. "Unipolar" refers to an ablation scheme that utilizes a current path between two electrodes, where one electrode having a high current density and a high electric flux density is positioned at the treatment site and a second electrode having a relatively low current density and a lower electric flux density is positioned remotely from the treatment site.

[0018] As discussed herein, the terms "tubular" and "tube" are to be construed broadly and are not limited to a straight cylindrical structure, or a structure with a cross-section that is strictly circular, or a structure with a uniform cross-section throughout its length. For example, a tubular / shaft structure is generally illustrated as a substantially straight cylindrical structure. However, the tubular / shaft structure may have a tapered or curved outer surface without departing from the scope of the present disclosure.

[0019] The present disclosure relates to a system, method, or use and device for IRE ablation of cardiac tissue for treating cardiac arrhythmias. Ablation energy is typically delivered to the cardiac tissue by a tip portion of a catheter that can deliver 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. An ablation procedure incorporating such an exemplary catheter can be visualized using fluoroscopy.

[0020] To improve a failing heart, ablation of heart tissue applying thermal techniques such as radiofrequency (RF) energy and cryoablation is a well-known procedure. Typically, to successfully ablate using thermal techniques, it is necessary to measure the electrocardiogram at various locations in the myocardium. In addition, temperature measurements during ablation provide data that enables assessment of the effectiveness of the ablation. Usually, in ablation procedures using thermal techniques, electrode potential and temperature are measured before, during, and after the actual ablation. The RF approach can have risks leading to tissue carbonization, burning, steam pops, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas. Cryoablation is an alternative approach to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, operating a cryoablation device and selectively applying cryoablation is generally more difficult compared to RF ablation. Thus, cryoablation is not feasible in certain anatomical shapes that can be reached by an electrical ablation device.

[0021] The present disclosure may include electrodes configured for irreversible electroporation (IRE), RF ablation, and / or cryoablation. IRE may be interchangeably referred to as pulsed electric field (PEF) ablation and pulsed field ablation (PFA) throughout the present disclosure. The IRE contemplated in the present disclosure is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. To ablate using IRE / PEF, a biphasic voltage pulse is applied to disrupt the cellular structure of the myocardium. The biphasic pulse is a non-sinusoidal waveform and can be tailored to target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat in the treatment area and indiscriminately heat all cells within the treatment area. Thus, IRE has the ability to spare adjacent thermosensitive structures or tissues, which would be beneficial in reducing possible complications known in ablation modalities or isolation modalities. Additionally or alternatively, monophasic pulses can be utilized.

[0022] Electroporation can be induced by applying a pulsed electric field to biological cells to cause reversible (temporary) or irreversible (permanent) formation of pores within the cell membrane. Cells have a transmembrane electrostatic potential that increases beyond the resting potential upon application of the pulsed electric field. The transmembrane electrostatic potential remains below the threshold potential, but electroporation is reversible, meaning that the pores can close when the applied pulsed electric field is removed and the cells can self-repair and survive. When the transmembrane electrostatic potential increases beyond the threshold potential, electroporation is irreversible and the cells become permanently permeable. As a result, the cells die due to loss of homeostasis and typically die by apoptosis. Generally, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500 V / cm, while bone has a threshold potential of 3000 V / cm. These differences in threshold potential allow IRE to selectively target tissue based on the threshold potential.

[0023] The techniques of the present disclosure include systems and methods for applying an electrical signal from a catheter electrode disposed in the vicinity of myocardial tissue to generate ablation energy for ablating the myocardial tissue. In some examples, the systems and methods can be effective for ablating target tissue by inducing irreversible electroporation. In some examples, the present systems and methods can be effective for inducing reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied at the electrodes is below the electric field threshold of the target tissue, which allows the cells to repair. Reversible electroporation does not kill the cells, but allows the physician to see the effect of reversible electroporation on the electroactivation signal in the vicinity of the target location. Exemplary systems and methods for reversible electroporation are disclosed in U.S. Patent Application Publication No. 2021 / 0162210, which is incorporated herein by reference in its entirety.

[0024] The effectiveness of a pulsed electric field, as well as a pulsed electric field that induces reversible electroporation and / or irreversible electroporation, can be affected by the physical parameters of the system and the biphasic pulse parameters of the electrical signal. The physical parameters can include electrode contact area, electrode spacing, electrode shape, and the like. The examples presented herein generally include physical parameters adapted to effectively induce reversible and / or irreversible electroporation. The biphasic pulse parameters of the electrical signal can include voltage amplitude, pulse duration, pulse phase delay, inter-pulse delay, total application time, delivered energy, and the like. In some examples, the parameters of the electrical signal can be adjusted to induce both reversible electroporation and irreversible electroporation when the same physical parameters are provided. Examples of various systems and methods of ablation that include IRE are presented in U.S. Patent Application Publication Nos. 2021 / 0169550(A1), 2021 / 0169567(A1), 2021 / 0169568(A1), 2021 / 0161592(A1), 2021 / 0196372(A1), 2021 / 0177503(A1), and 2021 / 0186604(A1), the entireties of each of which are incorporated herein by reference.

[0025] Refer to FIG. 1 showing an exemplary catheter-based electrophysiological mapping and ablation system 10. System 10 includes a plurality of catheters that are percutaneously inserted by a physician 24 into a chamber or vascular structure of the heart 12 through the vasculature of a patient 23. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location of the heart 12. Thereafter, a plurality of catheters can be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An exemplary medical device / probe configured to sense IEGM, such as catheter 14 (also referred to herein synonymously as medical probe 14), is shown herein. The physician 24 contacts the distal tip of the catheter 14 with the heart wall to sense a target site of the heart 12. For ablation, the physician 24 similarly moves the distal end of the ablation catheter to the target site for ablation.

[0026] Catheter 14 is an exemplary catheter that includes one electrode, preferably a plurality of electrodes 26, configured to sense IEGM signals. In the embodiments described herein, the electrodes 26 can be configured to deliver ablation energy (IRE and / or RF) to tissue within the heart 12. In addition to using the electrodes 26 to deliver ablation energy, the electrodes 26 can also be used to determine the position of the distal tip 28 and / or measure physiological characteristics such as local surface potential at each position on the tissue within the heart 12. The electrodes 26 can be biased such that most of the electrodes 26 face outwardly from the distal tip 28, whereby the electrodes 26 deliver a large amount of electrical energy outwardly (i.e., toward the tissue of the heart 12) away from the distal tip 28 rather than inwardly toward the distal tip 28.

[0027] Examples of materials that are ideally suitable for forming the electrode 26 include gold, platinum, and palladium (their respective alloys). These materials also have high thermal conductivity, which allows a minimal amount of heat generated in the tissue (i.e., due to ablation energy delivered to the tissue) to be conducted through the electrode to the back side of the electrode (i.e., the portion of the electrode 26 that is inside the spine) and then to the blood pool within the heart 12.

[0028] The catheter 14 may additionally include a position sensor embedded therein or near thereto for tracking the position and orientation of the distal tip 28. Optionally and preferably, the position sensor is a magnetic-based position sensor that includes three magnetic coils for sensing three-dimensional (3D) position and orientation.

[0029] The magnetic-based position sensor may operate with a position pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the distal tip 28 of the catheter 14 can be tracked based on the magnetic field generated by the location pad 25 and sensed by the magnetic-based position sensor. Details of the magnetic-based position sensing technology are described in U.S. Patent Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, each of which is incorporated herein by reference.

[0030] System 10 includes one or more electrode patches 38 disposed for skin contact on patient 23 to establish position referencing of position pad 25 and impedance-based tracking of electrodes 26. For impedance-based tracking, current is directed to electrodes 26 and sensed at electrode skin patches 38, whereby the position of each electrode can be triangulated via electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0031] Recorder 11 displays an electrogram 21 captured by body surface ECG electrodes 18 and an intracardiac electrogram (IEGM) captured by electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the rhythm of the heart and / or may be electrically connected to an independent pacer.

[0032] System 10 may include an ablation energy generator 50 adapted to deliver ablation energy to one or more of the electrodes at the distal tip of a catheter configured to ablate. The energy generated by ablation energy generator 50 may include radiofrequency (RF) energy or pulsed field ablation (PFA) energy, or a combination thereof, including unipolar or bipolar high voltage direct current (DC) or alternating current (AC) pulses that can be used to effect irreversible electroporation (IRE), but is not limited thereto.

[0033] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between a catheter, an electrophysiology device, a power source, and a workstation 55 that controls the operation of the system 10. The electrophysiology devices of the system 10 can include, for example, a plurality of catheters, position pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities for implementing real-time calculations of catheter positions and performing ECG calculations.

[0034] The workstation 55 includes a memory, a processor unit having a memory or storage device loaded with appropriate operating software, and user interface functions. The workstation 55 can optionally provide a plurality of functions including: (1) modeling endocardial anatomical structures in three dimensions (3D) and rendering them for display on a display device 27 as a model or anatomical map 20; (2) displaying on the display device 27 a representative visual display or image of an activation sequence (or other data) compiled from the recorded potential map 21 overlaid on the rendered anatomical map 20; (3) displaying the real-time positions and orientations of a plurality of catheters within the heart chamber; and (5) displaying on the display device 27 sites of interest such as locations where ablation energy is being applied. One commercially available product embodying the elements of the system (10) is available as the CARTO (trademark) 3 system, marketed by Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0035] FIG. 2 is a schematic drawing showing a front view of a medical probe 14 having a distal tip 28. The medical probe 14 according to the present disclosure generally includes an elongated body 100 that extends from a proximal end to a distal end along a longitudinal axis 60 and defines a lumen 104 that passes through the elongated body 100. The elongated body 100 is connected at its proximal end to a handle 200 and extends to a distal tip 28. The handle 200 includes a handle housing 202 and a pull wire control knob 204, which will be discussed in more detail below.

[0036] FIG. 3 is a schematic drawing showing a perspective view of a probe body 100 of a medical probe 14 with the distal tip inserted into a blood vessel 12A of the heart 12. As depicted illustratively, the elongated body 100 includes an elongated tube 102 (defining a lumen 104 and extending along a longitudinal axis 60) and an outer wall jacket 106 surrounding the tube 102.

[0037] The tube 102 can be monolithic (i.e., a single piece of material or member) in form and can be made from a biocompatible metallic material such as stainless steel rather than a braided mesh. In some embodiments, the tube 102 can be laser cut to a predetermined length. As will be understood by those skilled in the art, the elongated body 100 must be able to deflect in order to navigate the blood vessels it crosses when navigating within a patient 23. Thus, the tube 102 includes a plurality of slits 108 formed in the tube 102 so that the tube 102 can be deflected bidirectionally with respect to the longitudinal axis 60.

[0038] In some embodiments, these slits 108 can be laser cut in a direction substantially orthogonal to the longitudinal axis 60. However, the slits can take various forms as shown in FIG. 8. By way of example only, the slits can be formed in a helical shape 108C, a brickwork shape 108D, a dogbone shape 108E, a ball joint shape 108F, a double tail puzzle shape 108G, a T-slot shape 108H, and combinations thereof to achieve the flexibility necessary for proper operation of the medical probe 14.

[0039] FIG. 7 is a schematic drawing showing a top view of the distal tip 28, which is bent in two opposite directions, as shown by the phantom lines. In this embodiment, a plurality of first slits 108A can be formed on a first side of the tube 102, and a plurality of second slits 108B can be formed on a second side of the tube 102 opposite the first side, as shown in phantom lines in FIG. 3 and FIG. 7. Note that the slits 108 are shown in phantom lines in FIG. 3 and FIG. 7 due to the outer wall jacket 106 covering them. The slits 108 can be formed with different slit profiles that result in asymmetric deflection depending on the direction the tube 102 is bent. As shown by way of example, and with particular reference to FIG. 7, the first slits 108A can have a first width and the second slits 108B can have a second width that is greater than the first width.

[0040] As a result, when the tube 102 is deflected to its maximum extent in a clockwise direction (with respect to FIG. 7) (at a predetermined maximum applied force that does not cause permanent deformation of the tube 102), the elongated body 100 has a first bend radius R1 having a first radius of curvature. Conversely, when the tube 102 is deflected to its maximum extent in a counterclockwise direction (with respect to FIG. 7) (at a predetermined maximum applied force that does not cause permanent deformation of the tube 102), the elongated body 100 has a second bend radius R2 having a second radius of curvature that is smaller than that of the first bend radius R1. These different bend radii are possible due to the asymmetric design of the slits 108 in the tube 102.

[0041] The outer wall jacket 106 that covers the outer surface of the tube 102 can be formed from a flexible biocompatible electrical insulating material such as polyamide-polyether (Pebax) copolymer, polyethylene terephthalate (PET), urethane, polyimide, parylene, silicone, etc. In some examples, the insulating material can include biocompatible polymers including, but not limited to, polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) copolymer (PLGA), polycaprolactone (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonate, and polyanhydrides, and the ratio of specific polymers is selected to control the degree of the inflammatory reaction.

[0042] FIG. 4 is a schematic drawing showing a cross-sectional view obtained along line 4-4 of FIG. 3. FIG. 5 is a schematic drawing showing a cross-sectional view similar to FIG. 4, with a slightly modified configuration of the pull wire guide. FIG. 6 is a schematic drawing showing a cross-sectional view obtained along line 6-6 of FIG. 5.

[0043] Referring particularly to FIGS. 3-6, the medical probe 14 includes one or more pull wires 120, 122 that extend along the longitudinal axis 60 from the distal end to the proximal end of the elongated body 100. In the presently described embodiment, there are two pull wires, namely the first pull wire 120 and the second pull wire 122. Of course, it will be understood that other designs may include, for example, one, three, four, or more pull wire configurations without departing from the spirit and scope of the present disclosure.

[0044] The pull wires 120, 122 are connected to the elongated body 100 in such a way that the movement of each of the pull wires 120, 122 by the operation of the control knob 204 deflects the elongated body 100. As shown in FIG. 13, each pull wire 120, 122 is fed into the handle 200 and connected to the control knob 204, so that by the operation of the control knob 204, the pull wires 120, 122 deflect the elongated body 100 in different directions respectively. As an example, referring to FIG. 7, when the control knob 204 is operated in the first direction, the first guide wire 120 is wound around it, and the elongated body 100 is rotated in the clockwise direction. Continuing to refer to FIG. 7, the operation of the control knob 204 in the second opposite direction winds the second guide wire 122 around it, and the elongated body 100 is rotated in the counterclockwise direction.

[0045] To fix the first pull wire 120 and the second pull wire 122 to the elongated body 100 respectively, a first hole 110 can be formed on one side (its distal end) of the elongated body 100, and a second hole 112 can be formed on another side of the elongated body 100 (for example, the opposite side of the distal end). The first pull wire 120 is fed through the first hole 110, and the second pull wire 122 is fed through the second hole 112. The pull wires 120, 122 can be attached to the elongated tube 102 within the openings 110, 112, for example, by a welding process.

[0046] FIG. 4 shows one exemplary pull-wire feed configuration, while FIGS. 5 and 6 show another pull-wire feed configuration according to the techniques of the present disclosure. As shown in FIG. 4, pull-wires 120, 122 can be fed within lumen 104 from the distal end along longitudinal axis 60 to handle 200. In other embodiments, as shown in FIGS. 5 and 6, pull-wires 120, 122 can be fed through slots 102A defined within elongate tube 102, such that pull-wires 120, 122 are each sandwiched between elongate tube 102 and outer wall jacket 106 (see FIG. 6). These slots 102A can be formed in tube 102 by laser cutting along a predetermined length of elongate tube 102. Next, pull-wires 120, 122 are positioned within slots 102A before tube 102 is coated.

[0047] FIG. 9A is a schematic drawing showing flexible circuit 130 in an un-folded configuration. FIG. 9B is a schematic drawing showing flexible circuit 130 in a folded configuration according to the disclosed techniques.

[0048] Referring mainly to FIGS. 3, 4, 9A, and 9B, a flexible circuit 130 disposed on outer wall jacket 106 is provided at the distal tip 28 of medical probe 14 to provide position tracking, mapping, and / or ablation functionality. By way of example, flexible circuit 130 can be a flexible printed circuit board (PCB) having one or more layers and printed electrical interconnects. Flexible circuit 130 can be securely connected to distal tip 28 by heating a thermoplastic material on probe flexible circuit 130 and reflowing the thermoplastic material. As particularly seen in FIG. 9A, flexible circuit 130 is subdivided into a plurality of sections, namely a first section 132, one or more second sections 134, and a third section 136.

[0049] When assembled with the elongated body 100, the first section 132 extends generally parallel to the longitudinal axis 60. As schematically shown in FIG. 7, the first section 132 refers to the neutral axis of bending when the elongated body 100 is deflected.

[0050] As seen in FIGS. 3, 9A, and 9B, the second section 134 extends (substantially perpendicularly) from the first section 134. These sections 134 are partially or entirely wrapped around the outer diameter of the outer wall jacket 106 (see the wrap in FIGS. 9B and 3) and are used to support various electrodes and / or coils, which will be considered in more detail below. For example, there can be four second sections 134A - 134D of different widths or equal widths.

[0051] As illustrated by FIGS. 10A and 10B, another embodiment of the first section 132’ connects to any number of second sections 134’ (e.g., six second sections 134’) having various electrode / coil configurations (to be considered in more detail below). Moreover, the second sections 134, 134’ can include tabs 135’ that are used to assist in the assembly of the second sections 134, 134’ with the outer diameter of the outer wall jacket 106.

[0052] The third section 136 extends from the first section 132 and is wrapped / bent around the distal end portion of the elongated body 100 so as to extend into the lumen 104, which enables the electrical interconnection to be sent to (and, for example, connected by) the substrate connector 220 within the handle 200. In some embodiments, the third section 136 can be connected to a long flexible circuit 138 via an interconnection 137 (see FIG. 10C showing the terminations of the electrodes 26 and the coils 33 for anisotropic conductive film bonding, soldering, etc.), and the long flexible circuit 138 extends through the lumen 104 from near the proximal end portion to near the distal end portion to provide a connection to the substrate connector 220. Alternatively, the flexible circuit 130 and the long flexible circuit 138 can be configured as a single flexible circuit extending from near the proximal end portion of the elongated body 100 to near the distal end portion of the elongated body 100.

[0053] As described above, and particularly as seen in FIGS. 3 and 10A, one or more electrodes 26 are disposed on the surface of the flexible circuit 130. Specifically, the electrodes can be formed on one or more of the second sections 134 that wrap around the elongated body 100 and are designed to be placed in contact with the tissue of an organ (e.g., blood vessel 12A of the heart 12). As described above, when the thermoplastic material is heated and reflowed on the flexible circuit 130, the openings in the thermoplastic material can be laser drilled to expose the surface of the electrodes 26.

[0054] Furthermore, one or more coils 33 may be disposed on the flexible circuit 130 along the longitudinal axis 60. Each coil 33 is configured to generate a current when subjected to a magnetic field, and the current indicates the position of each coil 33. In some embodiments, each coil 33 may comprise a substantially flat spiral coil formed on one of the second sections 134A-134D. The coil 33 can include conductors for conducting the current induced on each coil 33 to the patient interface unit 30. As will be appreciated, by attaching a plurality of coils 33 to the distal tip 28, it is possible to detect its position. In this way, the physician 24 can more accurately determine the position of the distal tip before using the distal tip to sense anatomical signals and / or apply ablation energy to tissue within the heart 12.

[0055] As illustrated in FIGS. 3 and 10A, any number of coil 33 and electrode 26 configurations may be employed on the second section 134. For example, some second sections 134 may contain neither electrodes 26 nor coils (used primarily to attach the flexible circuit 130 to the elongated body 100), some second sections 134 may contain only electrodes 26, some second sections 134 may contain only coils 33, and some second sections 134 may contain a combination of electrodes 26 and coils 33.

[0056] As discussed above, the tube 102 of the present disclosure includes a slit 108 that provides the tube with a preferred two-direction bending motion whose neutral bending axis coincides with the longitudinal axis 60. When subjected to two-direction bending, the neutral layer of the tube 102 is vertically oriented and extends along a plane that is in the same plane as the longitudinal axis. For purposes of illustration and explanation, FIG. 11 shows the position where the neutral layer bisects the upper portion of the elongated body 100 (illustrated as the first neutral axis NA1 for purposes of explanation and referenced herein), and the position where the neutral layer bisects the lower portion of the elongated body 100 (illustrated as the second neutral axis NA2 for purposes of explanation and referenced herein).

[0057] Figures 12A - 16 illustrate alternative exemplary configurations of the flexible circuit 130 according to the present disclosure. These examples may share features of the previously described examples, and differences are described in the following explanations.

[0058] As seen in FIGS. 12A and 12B, the flexible circuit 130 - 1 includes a first section 132 - 1 having a meandering shape (in this embodiment, the waveform pattern thereof forms an angle of approximately 60 - 65 degrees with respect to the first neutral axis NA1), rather than extending substantially parallel to the longitudinal axis 60. The flexible circuit 130 - 1 also includes a second section 134 - 1 on which at least some of the electrodes 26 - 1 are disposed, an outer section of the meandering shape, one or more coils 33 - 1, and a coil alignment marker 135 - 1.

[0059] In FIG. 12A, the first neutral axis NA1 is depicted to show the positioning of the flexible circuit 130 - 1 when assembled with the tube 102 around the outer wall jacket 106. Specifically, as best shown in FIG. 12B, the amplitude of the meandering shape is selected such that the inner edges of the peaks / valleys are aligned (or substantially aligned) with the first neutral axis NA1 and with each other. In other words, by the amplitude (or width) of the first section 132 - 1 with respect to the circumference of the outer wall jacket 106, the first section 132 - 1 completely wraps around the outer wall jacket 106, and the peaks and valleys of the meandering shape are aligned with the first neutral axis NA1 on the upper part of the elongated body 100 (the peaks and valleys point in opposite directions). By aligning these inner edges on the neutral layer of the elongated body 100, the strain and compression on the peaks / valleys of the flexible circuit 130 - 1 can be reduced. It should also be noted that the edges of the coils 33 - 1 and the alignment marker 135 - 1 are configured with respect to the first section 132 - 1 to extend along the first neutral axis NA1 when assembled with the elongated body 100. This design can more reliably ensure proper alignment of the flexible circuit 130 - 1.

[0060] Figures 13A and 13B show the configuration of the flexible circuit 130-2, which is similar to that of the flexible circuit 130-1 shown in Figures 12A and 12B, but the meandering shape (in this embodiment, its wave pattern is angled approximately 50 to 55 degrees with respect to the first neutral axis NA1) is modified to wrap around only a portion rather than the entire circumference of the elongated body 100. The flexible circuit 130-2 also includes a second section 134-2 on which at least some of the electrodes 26-2 are disposed, an outer section of the meandering shape, one or more coils 33-2, and a coil alignment marker 135-2.

[0061] In Figure 13A, the first neutral axis NA1 and the second neutral axis NA2 are depicted to show the positioning of the flexible circuit 130-1 when assembled with the tube 102 around the outer wall jacket 106. Specifically, the amplitude of the meandering shape is selected such that the inner edge of the peak aligns (or substantially aligns) with the first neutral axis NA1 and the inner edge of the valley aligns (or substantially aligns) with the second neutral axis. In other words, due to the amplitude (or width) of the first section 132-2 with respect to the circumference of the outer wall jacket 106, the first section 132-2 wraps around half / one side of the outer wall jacket 106 (excluding the small portions of the peaks / valleys), and the peaks and valleys of the meandering shape align with the first neutral axis NA1 at the upper part of the elongated body 100 and the second neutral axis NA2 at the lower part of the elongated body 100, respectively. By aligning these inner edges on the neutral layer of the elongated body 100, the strain and compression with respect to the peaks / valleys of the flexible circuit 130-2 can be reduced. It should also be noted that the edges of the coil 33-2 and the alignment marker 135-2 are configured with respect to the first section 132-2 to extend along the first neutral axis NA1 when assembled with the elongated body 100. This design can more reliably ensure proper alignment of the flexible circuit 130-2.

[0062] Figures 14A and 14B show another exemplary configuration of the flexible circuit 130-3. In this embodiment, the flexible circuit 130-3 is wound in a spiral pattern (similar to the white, red, and blue stripes of the barber pole) around the outer wall jacket 106 of the elongated body 100. In some embodiments, the electrodes may be provided along the spiral surface such that when wound around the outer wall jacket 106, they form a spiral electrode surface. In this embodiment, the first section 132-3 of the flexible circuit 130-3 includes a straight section 132-3 that is orthogonal to the longitudinal axis 60 when wound around the outer wall jacket 106. As seen in FIG. 14B, the electrodes 26-3 can be arranged along these straight sections 132-3 so as to be orthogonal to the longitudinal axis 60 (i.e., not spiral along the longitudinal axis 60). These electrodes 26-3 can also be arranged on a section similar to section 134 shown in FIG. 9A that projects from the first section so as to extend orthogonally to the longitudinal axis 60 when wound around the outer wall jacket 106.

[0063] Figures 15A to 15C show examples similar to those of Figures 12A and 12B and Figures 13A and 13B. In Figure 15A, the flexible circuit 130-4.1 includes a meandered first section 132-4.1 and a plurality of second sections 134-4.1, at least some of which support the electrode 26-4.1. In this example, the second section 134.4.1 is configured as a flap protruding from one side of the first section 132-4.1. In Figure 15B, the flexible circuit 130-4.2 includes a meandered first section 132-4.2 and a plurality of second sections 134-4.2, at least some of which support the electrode 26-4.2. In this example, the second sections 134.4.2 are each configured as a flap protruding from both sides of the first section 132-4.2. In Figure 15C, the flexible circuit 130-4.3 includes a meandered first section 132-4.3 and a plurality of second sections 134-4.3, at least some of which support the electrode 26-4.3. In this example, the second section 134.4.3 is configured as a flap protruding alternately from different sides of the meandered first section 132-4.3, such that the second section does not coincide with or extend from the inner curve (i.e., the concave portion) of the first section 132-4.3.

[0064] Figure 16 shows an example similar to that of the embodiments of Figures 14A and 14B, wrapped around the outer wall jacket 106. The flexible circuit 130-5 includes one or more coils 33-5, a first section 132-5 that is spirally wound around the elongated body 100 when assembled, a plurality of second sections 134-5, at least some of which have electrodes 26-5 provided thereon, and a coil alignment marker 135-5. In this example, adjacent second sections 134-5 that support the electrode 26-5 can be physically (but not electrically) connected to each other to assist in support and assembly with the elongated body 100.

[0065] Figures 17 to 21 show an exemplary method of assembling the above-described flexible circuit on an elongated body 100.

[0066] As seen in FIG. 17, a method 1700 of assembling a flexible circuit may include the following. The flexible circuit is wound 1702 around the catheter tip (e.g., distal tip 28). The flexible circuit is fastened to the catheter tip (i.e., at least temporarily held / maintained in a fixed position) 1704. The flexible circuit is wound 1706 together with a biocompatible sheet such as a polymer like TPU. The TPU is reflowed 1708 and the electrode surface of the flexible circuit is exposed 1710.

[0067] As seen in FIG. 18, another method 1800 of assembling a flexible circuit may include the following. The flexible circuit is laminated (1802) on a biocompatible sheet (e.g., TPU), and the biocompatible sheet covers the electrodes disposed on the flexible circuit. The laminated flexible circuit and TPU are wound 1804 around the catheter tip (e.g., distal tip 28). The laminated flexible circuit and TPU are fastened to the catheter tip 1808. The TPU is reflowed 1808 and the electrode surface of the flexible circuit is exposed 1810.

[0068] As seen in FIG. 19, another method 1900 of assembling a flexible circuit may include the following. The flexible circuit is laminated 1902 on a biocompatible sheet (e.g., TPU), and the electrodes disposed on the flexible circuit face away from the TPU. The laminated flexible circuit and TPU assembly are wound 1904 around the catheter tip (e.g., distal tip 28). The laminated flexible circuit and TPU are fastened to the catheter tip 1906. The TPU is reflowed 1908. Since the electrodes were initially positioned facing away from the TPU, they are exposed in the final assembly.

[0069] As shown in FIG. 20, another method 2000 of assembling a flexible circuit may include the following. Windows in a biocompatible sheet (e.g., TPU) are cut 2002 corresponding to electrode positions in the flexible circuit. The TPU is laminated 2004 onto the flexible circuit such that the electrodes are exposed through the windows. The laminated flexible circuit and TPU assembly is wrapped around the catheter tip (e.g., distal tip 28).

[0070] As shown in FIG. 21, another method 2100 of assembling a flexible circuit may include the following. A biocompatible sheet (e.g., TPU) is reflowed 2102 relative to the catheter tip (e.g., distal tip 28). One end of the flexible circuit is fastened 2104 to the TPU. The flexible circuit is wound 2106 around the catheter tip. The other end of the flexible circuit is fastened 2108 to the TPU. The TPU is reflowed again (2110), whereby the flexible circuit is joined to the TPU.

[0071] In addition to the above-described methods, the flexible circuit may be wound and fastened (e.g., using an adhesive) onto the catheter tip, and then the catheter and flex may be overmolded using a suitable low-temperature process (e.g., liquid silicone) using appropriate features within the tooling to ensure that the electrode surfaces remain exposed.

[0072] FIG. 22 is a schematic drawing showing a first connection feature for connecting the proximal end of the elongate tube 100 to the handle 200 of the medical probe 14. FIG. 23 is a schematic drawing showing a second connection feature for connecting the proximal end of the elongate tube 100 to the handle 200 of the medical probe 14. FIG. 24 is a schematic drawing showing a cross-sectional view of the handle 200.

[0073] Referring particularly to FIGS. 22-24, in addition to the above, the handle housing 202 can be formed from two shells 202A, 202B, to which a pull wire control knob 204 is rotatably connected, and the board connector 220 is disposed within its cavity. The handle 200 and the proximal end portion of the elongated body 100 can include several connection features to simplify the assembly process.

[0074] For example, positioning protrusions 214 (formed as pins, for example) can be provided on the handle 200 that align with and fit into complementary positioning holes 114 defined in the proximal end portion of the elongated body 100. Of course, in some embodiments, this configuration can be reversed such that the holes 114 are defined within the handle 200 and the positioning protrusions 214 are formed on the elongated body 100. Additionally, a clip 206 can be provided on the handle 200 that engages the outer wall jacket 106. When used in relation to each other, the clip 206 serves to maintain the engagement between the positioning hole 114 and the positioning protrusion 214. Further, the handle 200 can include a seal 208 between the handle 200 and the outer wall 106 of the elongated body 100, which provides a sealing effect without the need for an adhesive.

[0075] In the following description, by way of example, it is assumed that a target region (e.g., blood vessel 12A) is being mapped and / or ablated. Of course, it will be understood that the techniques described herein can be employed to ablate and / or map other regions of the heart 12.

[0076] In a first step, the physician 24 inserts the distal tip 28 into the subject. The coil 33 and / or the electrodes 26 can be used to navigate the medical probe 14 within the subject. Once the distal tip 28 of the probe 14 is properly positioned, the flexible circuit 130 including the electrodes 26 is pressed against the blood vessel 12A.

[0077] In the mapping step, when the electrode 26 contacts and is properly positioned with respect to the blood vessel 12A, the electrode 26 generates a potential gradient signal (also referred to herein as an electrical signal) in response to the sensed potential. In some examples, the sensed electrical signal indicates at least one characteristic of an anatomical signal, such as the direction and propagation speed of a wavefront caused by an anatomical signal such as an electrocardiogram (ECG) signal within the heart 12.

[0078] In the ablation step, the physician 24 operates the processor 55 and the ablation energy generator 50 to supply current to the electrodes 26 of the flexible membrane 110. If two or more electrodes 26 are present, then the supplied current may be bipolar, i.e., the current may flow between the electrodes 26 to transfer ablation energy to the tissue. Alternatively, the supplied ablation energy may be unipolar, i.e., a current may be applied between one of the electrodes 26 and a return electrode connected to the generator 50. The return electrode may be disposed outside the body of the patient 23. For example, the return electrode may include a patch (such as patch 38, etc.) coupled to the patient's body.

[0079] In some examples, (alternating current) current such as an RF sine wave is supplied to the electrodes 26, so that RF ablation of the tissue is performed. Alternatively, pulsed current (e.g., DC or AC) may be supplied to perform irreversible electroporation (IRE) or pulsed field ablation (PFA). When pulsed current is supplied to perform PFA, unipolar ablation energy may be supplied by the current flowing between the electrode 26 on the flexible membrane 110 and the electrode patch 38 or the back patch. Moreover, bipolar ablation energy may be supplied by the current flowing between the electrodes 26 on the flexible membrane 110 itself and / or on another catheter within another part of the heart 12.

[0080] After mapping and / or completion, physician 24 can retract the distal tip 28 from the blood vessel 12A and remove the probe 14 from the subject or move it to another area of the heart 12 that requires mapping and / or ablation.

[0081] The techniques of the present disclosure described herein can be further understood in accordance with the following clauses.

[0082] Clause 1. An elongated body extending along a longitudinal axis from a proximal end to a distal end, the elongated body being a tube defining a lumen and extending along the longitudinal axis, the tube comprising a plurality of slits formed in the tube, the slits enabling the elongated body to deflect with respect to the longitudinal axis, a tube, an outer wall jacket surrounding the tube, and a flexible circuit disposed on the outer wall jacket, and an elongated body, and one or more electrodes disposed on the flexible circuit and configured to be placed in contact with the tissue of an organ.

[0083] Clause 2. The medical probe according to clause 1, further comprising one or more coils disposed on the flexible circuit along the longitudinal axis, each coil being configured to generate an electric current when receiving a magnetic field, the electric current indicating the position of each coil.

[0084] Clause 3. The medical probe according to clause 2, wherein each of the coils comprises a substantially flat spiral coil.

[0085] Clause 4. The medical probe according to any one of clauses 1 to 3, wherein the lumen is defined by the tube.

[0086] Clause 5. The medical probe according to any one of clauses 1 to 4, wherein the plurality of slits are formed asymmetrically in the tube.

[0087] Clause 6. A plurality of first slits, each first slit having a first width, and a plurality of second slits, each second slit having a second width wider than the first width, the medical probe according to any one of Clauses 1 to 5.

[0088] Clause 7. The medical probe according to Clause 6, wherein each first slit is formed on a first side surface of the tube, and each second slit is formed on a second side surface of the tube.

[0089] Clause 8. The medical probe according to any one of Clauses 1 to 7, wherein the elongated body has a first radius of curvature when deflected in a first direction and a second radius of curvature when deflected in a second direction.

[0090] Clause 9. The medical probe according to any one of Clauses 1 to 8, wherein each of the plurality of slits is formed in a direction substantially orthogonal to the longitudinal axis.

[0091] Clause 10. The medical probe according to any one of Clauses 1 to 9, further comprising a first pull wire, the first pull wire having a first end coupled to the distal end of the elongated body and configured to move to deflect the elongated body.

[0092] Clause 11. The medical probe according to Clause 10, wherein the first pull wire extends through a lumen along the longitudinal axis.

[0093] Clause 12. The medical probe according to Clause 10, wherein the first pull wire is sandwiched between the tube and an outer wall jacket along the longitudinal axis.

[0094] Clause 13. The medical probe according to any one of Clauses 10 to 12, further comprising a second pull wire, the second pull wire having a first end coupled to the distal end of the elongated body and configured to move to deflect the elongated body.

[0095] Clause 14. The medical probe according to any one of Clauses 1 to 13, wherein the flexible circuit comprises a first section extending substantially parallel to the longitudinal axis, one or more second sections extending from the first section and wrapping around the outer wall jacket, and a third section extending from the first section and wrapping around the distal end portion of the elongated body and extending into the lumen.

[0096] Clause 15. The medical probe according to Clause 14, further comprising a long flexible circuit connected to the third section and extending through the lumen.

[0097] Clause 16. The medical probe according to Clause 14 or 15, wherein the flexible circuit includes a single flexible circuit extending from near the proximal end portion of the elongated body to near the distal end portion of the elongated body.

[0098] Clause 17. The medical probe according to any one of Clauses 1 to 13, wherein the flexible circuit comprises a first section including a meandering shape along the longitudinal axis, and one or more second sections extending from the first section and at least partially wrapping around the outer wall jacket, and one or more electrodes are disposed on at least one of the one or more sections.

[0099] Clause 18. The medical probe according to any one of Clauses 1 to 17, further comprising a handle, wherein the proximal end portion of the elongated body is connected to the handle via a positioning protrusion and a positioning opening configuration, (i) the positioning protrusion is disposed on one of the elongated body and the handle, and (ii) the positioning opening is on the other of the handle and the elongated body.

[0100] Clause 19. The medical probe according to Clause 18, wherein a connector is housed in the handle, and the proximal end portion of the long flexible circuit is connected to the connector.

[0101] Clause 20. The medical probe according to clause 18 or 19, wherein the positioning hole is defined through the proximal end of the elongated body, the positioning protrusion is provided on the handle, and is fitted with the positioning hole along a direction substantially perpendicular to the longitudinal axis.

[0102] Clause 21. The medical probe according to any one of clauses 18 to 20, further comprising a clip that engages with the outer wall jacket of the elongated body.

[0103] Clause 22. The medical probe according to any one of clauses 18 to 21, further comprising a seal between the handle and the outer wall jacket of the elongated body.

[0104] Clause 23. The medical probe according to any one of clauses 1 to 22, wherein the tube is a monolithic member and includes a biocompatible metal material.

[0105] Clause 24. The medical probe according to any one of clauses 1 to 23, wherein the outer wall jacket includes a biocompatible polymer material.

[0106] Clause 25. A method of forming a medical probe, the method comprising the steps of laser cutting a tube to a predetermined length, laser cutting a plurality of slits in the tube that allow the tube to deflect with respect to the longitudinal axis, covering the outer surface of the tube with an outer wall jacket, at least partially winding a flexible circuit having one or more electrodes around the outer wall jacket, heating a thermoplastic material on the flexible circuit and reflowing the thermoplastic material, and laser drilling the thermoplastic material to open an aperture to expose the surface of one or more electrodes.

[0107] Clause 26. The method according to clause 25, wherein the probe flexible circuit comprises one or more coils, each coil being configured to generate a current when subjected to a magnetic field, the current indicating the position of each coil.

[0108] The method according to clause 25 or 26, further comprising the step of folding the probe flexible circuit and extending a portion of the probe flexible circuit into the lumen of the tube.

[0109] The method according to clause 27, further comprising the step of connecting the distal end portion of the long flexible circuit to a part of the probe flexible circuit and the step of connecting the proximal end portion of the long flexible circuit to a connector housed within the handle.

[0110] The method according to any one of clauses 25 to 29, further comprising the step of welding the distal end portion of the pull wire to the distal tip of the tube and the step of feeding the pull wire along the tube.

[0111] The method according to clause 29, further comprising the step of laser cutting a slot in the tube along a predetermined length of the tube and the step of positioning the pull wire within the slot.

[0112] The above-described embodiments are cited by way of example, and the disclosed technology is not limited to that specifically illustrated and described in the above specification. Rather, the scope of the disclosed technology includes both the various combinations and sub-combinations of the features described above, as well as those variations and modifications thereof that would occur to those skilled in the art upon reading the foregoing description and that are not disclosed in the prior art.

[0113] 〔Embodiment〕 (1) A medical probe, An elongated body extending along a longitudinal axis from a proximal end portion to a distal end portion, the elongated body defining a lumen, A tube extending along the longitudinal axis, the tube comprising a plurality of slits formed in the tube, the slits enabling the elongated body to deflect with respect to the longitudinal axis, An outer wall jacket surrounding the tube, A flexible circuit disposed on the outer wall jacket, and an elongated body comprising the same. One or more electrodes disposed on the flexible circuit and configured to be in contact with the tissue of the organ, and a medical probe comprising the same. (2) The medical probe according to embodiment 1, further comprising one or more coils disposed on the flexible circuit along the longitudinal axis, each coil being configured to generate an electric current when receiving a magnetic field, and the electric current indicating the position of each coil. (3) The medical probe according to embodiment 2, wherein each of the coils includes a substantially flat spiral coil. (4) The medical probe according to embodiment 1, wherein the lumen is defined by the tube. (5) The medical probe according to embodiment 1, wherein the plurality of slits are formed asymmetrically in the tube.

[0114] (6) The plurality of slits are a plurality of first slits, each first slit having a first width, and a plurality of second slits, each second slit having a second width wider than the first width, and the medical probe according to embodiment 1. a plurality of second slits, each second slit having a second width wider than the first width, and the medical probe according to embodiment 1. (7) The medical probe according to embodiment 1, wherein the elongated body has a first radius of curvature when deflected in a first direction and a second radius of curvature when deflected in a second direction. (8) The medical probe according to embodiment 1, wherein each of the plurality of slits is formed in a direction substantially orthogonal to the longitudinal axis. (9) The medical probe according to embodiment 1, further comprising a first pull wire, the first pull wire having a first end coupled to the distal end of the elongated body and configured to move to deflect the elongated body. (10) The flexible circuit is a first section extending substantially parallel to the longitudinal axis, and One or more second sections extending from the first section and wrapping around the outer wall jacket A third section extending from the first section and wrapping around the most distal end of the elongated body and extending into the lumen, the medical probe according to embodiment 1

[0115] (11) The medical probe according to embodiment 10, further comprising a long flexible circuit connected to the third section and extending through the lumen (12) The medical probe according to embodiment 10, wherein the flexible circuit includes a single flexible circuit extending from near the proximal end of the elongated body to near the distal end of the elongated body (13) The flexible circuit A first section including a meandering shape along the longitudinal axis, and One or more second sections extending from the first section and at least partially wrapping around the outer wall jacket, wherein the one or more electrodes are disposed on at least one of the one or more sections, the medical probe according to embodiment 1 (14) Further comprising a handle, wherein the proximal end of the elongated body is connected to the handle via a positioning protrusion and a positioning opening configuration, (i) the positioning protrusion is disposed on one of the elongated body and the handle, (ii) the positioning opening is on the other of the handle and the elongated body, the medical probe according to embodiment 1 (15) A positioning hole is defined through the proximal end of the elongated body, the positioning protrusion is provided on the handle and fits with the positioning hole along a direction substantially perpendicular to the longitudinal axis, the medical probe according to embodiment 14

[0116] (16) The medical probe according to embodiment 14, further comprising a clip engaging with the outer wall jacket of the elongated body (17) The medical probe according to embodiment 1, wherein the tube is a monolithic member and includes a biocompatible metal material. (18) A method of forming a medical probe, the method comprising: laser cutting the tube to a predetermined length; laser cutting a plurality of slits in the tube that enable the tube to deflect with respect to the longitudinal axis; covering an outer surface of the tube with an outer wall jacket; at least partially winding a flexible circuit having one or more electrodes around the outer wall jacket; heating a thermoplastic material on the flexible circuit and reflowing the thermoplastic material; laser drilling the thermoplastic material to form an opening to expose a surface of the one or more electrodes. (19) The method according to embodiment 18, further comprising folding the flexible circuit and extending a portion of the flexible circuit into the lumen of the tube. (20) Welding a distal end of a pull wire to a distal tip of the tube; The method according to embodiment 18, further comprising feeding the pull wire along the tube.

Claims

1. 1. A medical probe, comprising: an elongate body extending along a longitudinal axis from a proximal end to a distal end, the elongate body defining a lumen; a tube extending along the longitudinal axis, the tube including a plurality of slits formed therein, the slits allowing the elongate body to deflect relative to the longitudinal axis; and an outer jacket surrounding the tube; an elongated body comprising: a flexible circuit disposed on the outer jacket; one or more electrodes disposed on the flexible circuit and configured to be placed in contact with tissue of an organ.

2. 10. The medical probe of claim 1, further comprising one or more coils disposed on the flexible circuit along the longitudinal axis, each coil configured to generate an electric current when subjected to a magnetic field, the electric current being indicative of a position of the respective coil.

3. The medical probe of claim 2 , wherein each of the coils comprises a generally flat helical coil.

4. The medical probe of claim 1 , wherein the lumen is defined by the tube.

5. The medical probe of claim 1 , wherein the plurality of slits are asymmetrically formed in the tube.

6. The plurality of slits are a plurality of first slits, each first slit having a first width; The medical probe of claim 1 , comprising: a plurality of second slits, each second slit having a second width that is greater than the first width.

7. The medical probe of claim 1 , wherein the elongate body has a first radius of curvature when deflected in a first direction and a second radius of curvature when deflected in a second direction.

8. The medical probe of claim 1 , wherein each slit of the plurality of slits is formed in a direction substantially perpendicular to the longitudinal axis.

9. 10. The medical probe of claim 1, further comprising a first pull wire having a first end coupled to a distal end of the elongate body and configured to move to deflect the elongate body.

10. The flexible circuit comprises: a first section extending generally parallel to the longitudinal axis; one or more second sections extending from the first section and wrapping around the outer wall jacket; 10. The medical probe of claim 1, comprising: a third section extending from the first section and wrapped around a distal-most end of the elongate body and extending into the lumen.

11. The medical probe of claim 10 , further comprising an elongate flexible circuit connected to the third section and extending through the lumen.

12. The medical probe of claim 10 , wherein the flexible circuit comprises a single flexible circuit extending from near the proximal end of the elongate body to near the distal end of the elongate body.

13. The flexible circuit comprises: a first section including a serpentine shape along the longitudinal axis; 10. The medical probe of claim 1, further comprising: one or more second sections extending from the first section and wrapping at least partially around the outer wall jacket, the one or more electrodes being disposed on at least one of the one or more sections.

14. 2. The medical probe of claim 1, further comprising a handle, a proximal end of the elongated body connected to the handle via a positioning protrusion and positioning aperture arrangement, (i) the positioning protrusion disposed on one of the elongated body and the handle, and (ii) the positioning aperture on the other of the handle and the elongated body.

15. 15. The medical probe of claim 14, wherein a location hole is defined through a proximal end of the elongate body, the location protrusion being on the handle and mating with the location hole along a direction generally perpendicular to the longitudinal axis.

16. The medical probe of claim 14 , further comprising a clip that engages the outer wall jacket of the elongate body.

17. The medical probe of claim 1 , wherein the tube is a monolithic member and comprises a biocompatible metallic material.

18. 1. A method of forming a medical probe, the method comprising: laser cutting the tube to length; laser cutting a plurality of slits in the tube that allow the tube to deflect relative to a longitudinal axis; covering an exterior surface of the tube with an outer wall jacket; wrapping a flexible circuit comprising one or more electrodes at least partially around the outer wall jacket; heating the thermoplastic material on the flexible circuit to reflow the thermoplastic material; and laser drilling openings in the thermoplastic material to expose surfaces of the one or more electrodes.

19. 20. The method of claim 18, further comprising folding the flexible circuit to extend a portion of the flexible circuit into a lumen of the tube.

20. welding a distal end of a pull wire to the distal tip of the tube; 20. The method of claim 18, further comprising: routing the pull wire along the tube.

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