Wire for multi-electrode catheter

Abstract

In one embodiment, a catheter includes a shaft assembly having a proximal end and a distal end (the distal end including a deflectable segment including a lumen longitudinally running therein), a plurality of electrodes disposed at the distal end, a connector disposed at the proximal end for coupling to processing circuitry, a cable disposed in the lumen (each cable electrically coupled to the connector and a respective set of electrodes, wherein each cable includes a bundle of wires (each wire connected to a respective one of the electrodes in the respective set), an electrical shield surrounding the bundle, and an electrically insulative jacket surrounding the electrical shield and sized to allow longitudinal movement of the respective cable within the respective lumen), a respective elongate member disposed in a second respective lumen in the lumen and connected to the distal end, and a manipulator connected to the elongate member to actuate the distal end via the elongate member.

Description

Technical Field

[0001] This invention relates to medical devices, and specifically, but not exclusively, to multi-electrode catheters. Background Technology

[0002] Electrode catheters have been widely used in medical practice for many years. They are used to stimulate and map electrical activity in the heart, as well as to ablate sites of abnormal electrical activity. In use, the electrode catheter is inserted into the ventricle. Once the catheter is positioned, the location of abnormal electrical activity within the heart is pinpointed.

[0003] One localization technique involves an electrophysiological mapping procedure whereby electrical signals emanating from conductive endocardial tissue are systematically monitored and mapped. By analyzing this mapping, physicians can identify interfering electrical pathways. A conventional method for mapping electrical signals from conductive cardiac tissue is to insert an electrophysiological catheter (electrode catheter) through the skin, which has mapping electrodes mounted at its distal end. The catheter is manipulated to position these electrodes in contact with or adjacent to the endocardium. By monitoring the electrical signals at the endocardium, abnormally conductive tissue sites causing arrhythmias can be identified.

[0004] For mapping, relatively small mapping electrodes are desirable. It has been found that smaller electrodes record more accurate and discrete electrograms. Additionally, if a bipolar mapping arrangement is used, it is desirable that the two electrodes in the mapping arrangement are close to each other and that they are similar in size to produce more accurate and useful electrograms.

[0005] Once the origin of the arrhythmia has been located in the tissue, physicians use ablation procedures to destroy the tissue causing the arrhythmia in an attempt to eliminate the abnormal electrical signal and restore a normal heartbeat or at least improve it. Successful ablation of conductive tissue at the site of the arrhythmia usually terminates the arrhythmia or at least slows the heart rate to an acceptable level.

[0006] Multi-electrode catheters come in various forms, including flower catheters, balloon catheters, and basket catheters, by way of example only. Some catheters may have dozens of electrodes, and some have more than one hundred electrodes. These multi-electrode catheters facilitate streamlining and accelerate mapping or ablation procedures. However, as the number of electrodes increases, the complexity of coupling the electrodes to the control unit of the catheter via the catheter axis also increases, and the catheter axis has a limited size due to the inherently limited size of the blood vessels that the catheter must traverse.

[0007] U.S. Patent Publication 2004 / 0193021 by Zdeblick et al. describes a multiplexed medical carrier for sensing one or more patient parameters and / or delivering energy via individually identifiable effectors. The carrier includes a body and at least two electrical conductors coupled to at least two effectors. Effectors can be sensors, actuators, or any combination of both. Sensors can measure parameters such as pressure, oxygen content, volume, conductivity, fluid flow rate, or any other chemical or physical parameter. Actuators can be used, for example, to pace the heart, stimulate muscle or nerve tissue, broadcast ultrasound energy, emit light, heat, or other forms of radiation, or deliver any form of energy or substance.

[0008] Edwards Lifesciences Corporation's PCT patent publication WO1998 / 014114 describes a catheter comprising a body portion having a distal end and a proximal end. Multiple lumens are formed in the body portion between the distal and proximal ends. A heating element and a temperature sensor are disposed on the catheter, with the temperature sensor positioned between the heating element and the distal end of the body portion. A heating element wire is connected to the heating element and extends from the heating element to the proximal end of the body portion within one of the lumen of the catheter, and a temperature sensor wire is connected to the temperature sensor and extends from the temperature sensor to the proximal end of the body portion in a twisted configuration within one of the lumen of the catheter. The heating element wire can be connected to a control unit and transmits an activation signal from the control unit to the heating element to activate it. The temperature sensor wire can be connected to a processing unit and transmits a temperature sensor signal from the temperature sensor to the processing unit for processing.

[0009] U.S. Patent Publication 2009 / 0275838 by Marshall et al. describes a catheter assembly for an intravascular ultrasound system, the intravascular ultrasound system including a catheter, an imaging core, and a shielding coupling capacitor. The catheter defines a lumen extending along its longitudinal length. The imaging core is configured and arranged for insertion into the lumen. The imaging core includes a rotatable drive shaft, one or more transducers, one or more conductors, and a conductive shield. The one or more transducers are mounted to the rotatable drive shaft. The one or more conductors are coupled to the one or more transducers and extend along the drive shaft. The conductive shield is disposed around the one or more conductors. The shielding coupling capacitor is electrically coupled to the conductive shield and includes one or more rotating capacitors. The one or more rotating capacitors include one or more rotating plates and one or more stationary plates. The shielding coupling capacitor is configured and arranged for coupling to a system ground terminal.

[0010] Selkee's U.S. Patent Publication 2010 / 0063478 describes a force-sensing catheter for diagnosing or treating blood vessels present in the body or body space. The force-sensing catheter includes a central strut bonded, preferably thermally bonded, along its longitudinal axis to a thermoplastic tubular member housing the central strut. The tubular member preferably has three layers: an inner layer, a braided layer, and an outer layer. One or more semiconductor or metal foil strain gauges are attached to the central strut to provide measurements of bending and torsional forces at the distal end of the catheter. Temperature compensation is achieved by having a temperature sensor located near the strain gauges and calibrating the catheter within a certain temperature range. Summary of the Invention

[0011] According to an embodiment of the present disclosure, a catheter is provided configured for insertion into a body part of a living subject and includes: a shaft assembly having a proximal end and a distal end (the distal end including a deflectable segment including a lumen traveling longitudinally within the deflectable segment); a plurality of electrodes disposed at the distal end of the shaft assembly; a connector disposed at the proximal end of the shaft assembly for coupling to processing circuitry; a plurality of cables disposed in a first corresponding lumen within the lumen (each cable electrically coupled to the connector and a corresponding group of electrodes, wherein each cable includes a bundle of individually insulated wires (each wire connected to a corresponding one of the electrodes in the corresponding group); an electrical shield surrounding the bundles; and an electrical insulating sheath surrounding the electrical shield and sized to allow longitudinal movement of the corresponding cable within the corresponding lumen); a corresponding elongated member disposed in a second corresponding lumen within the lumen and connected to the distal end; and a manipulator connected to the elongated member and configured to actuate the distal end via the elongated member.

[0012] According to further embodiments of this disclosure, the manipulator is configured to change the orientation of the deflectable segment via at least one of the elongated members.

[0013] Furthermore, according to an embodiment of the present disclosure, the distal end includes an assembly having a plurality of electrodes disposed thereon, at least one of the elongated members being coupled to the assembly, and the manipulator being configured to deploy the assembly via at least one elongated member.

[0014] Additionally, according to embodiments of this disclosure, the catheter includes two corresponding resilient elongated members disposed in a third corresponding lumen within the lumen, the two resilient elongated members defining a preferred bending plane of the deflectable segment.

[0015] Furthermore, according to the embodiments of this disclosure, the deflectable section has an outer diameter of less than 3 mm.

[0016] Further according to an embodiment of this disclosure, each of the cables has an outer diameter of less than 0.5 mm and comprises at least twenty insulated wires.

[0017] Furthermore, according to the embodiments disclosed herein, the conduit includes at least three cables.

[0018] In addition, according to the embodiments of this disclosure, each of the cables has an outer diameter of less than 0.5 mm and includes at least thirty insulated wires.

[0019] Furthermore, according to the embodiments disclosed herein, the conduit includes at least three cables.

[0020] Further according to an embodiment of this disclosure, each corresponding cable includes a strip of wire bundle wrapped around the insulating wires beneath the shield.

[0021] Furthermore, according to embodiments of this disclosure, the electrical insulation sheath comprises one or more of the following: polytetrafluoroethylene (PTFE) or perfluoroalkoxyalkane (PFA).

[0022] Additionally, according to embodiments of this disclosure, the deflectable segment includes a thermoplastic elastomer.

[0023] Furthermore, according to embodiments of this disclosure, the electrical shielding includes a non-overlapping wire spiral portion.

[0024] Further according to the embodiments of this disclosure, the electrical shielding material comprises a tin-copper alloy. Attached Figure Description

[0025] The invention will be understood from the following detailed description taken in conjunction with the accompanying drawings, wherein:

[0026] Figure 1 This is a schematic diagram of a system for electroanatomical mapping according to an embodiment of the present invention, the system comprising a catheter;

[0027] Figure 2 for Figure 1 A transverse cross-sectional view of the deflectable segment of the catheter;

[0028] Figure 3 for Figure 1 A transverse cross-sectional view of a deflectable segment, wherein the lumen of the deflectable segment is loaded;

[0029] Figure 4 for Figure 1 A cross-sectional view of the deflectable segment of the catheter; and

[0030] Figure 5 To include Figure 3 A cross-sectional view of one of the cables in the deflectable segment. Detailed Implementation

[0031] Overview

[0032] As previously discussed, multi-electrode catheters come in various forms, including flower catheters, balloon catheters, and basket catheters, to name only. Some catheters may have dozens of electrodes, and some may have more than one hundred. These multi-electrode catheters facilitate streamlining and accelerate mapping or ablation procedures. However, as the number of electrodes increases, so does the complexity of coupling the electrodes to the catheter control unit via the catheter shaft assembly. Due to the inherently limited size of the blood vessels that the catheter must traverse, the catheter shaft assembly has a limited size. Furthermore, if the internal components of the catheter shaft assembly are too thick, even if the shaft assembly itself is narrower than the blood vessel, the shaft assembly may not have the necessary flexibility for traversing the vessel.

[0033] Adding to the complexity of coupling the electrodes to the control unit via the conduit shaft assembly are the presence of other items within the shaft assembly, such as mechanical elements for controlling the deflection of a deflectable segment at the distal end of the shaft assembly, and / or mechanical elements for deploying and controlling the distal end assembly (such as a basket or balloon) on which the electrodes are disposed. Other elements, such as flushing tubing, may also be incorporated into the shaft assembly.

[0034] Another problem associated with coupling the electrodes to the control unit is that electrical noise is generated on the wires coupling the electrodes to the control unit due to electrostatic discharge from the wire insulation when the conduit deflects. Since the electrical activity sensed by the electrodes is on the order of millivolts with microvolt resolution, the noise generated in the wires can significantly affect the accuracy of the sensed electrical activity.

[0035] An additional problem associated with coupling the electrodes to the control unit is that the wire requires a certain amount of freedom of motion within the deflectable section; otherwise, the wire could break when the deflectable section deflects. Therefore, the wire requires space within the deflectable section to provide this degree of freedom of motion.

[0036] As mentioned above, the available space in the deflectable segment is used for many items, and the maximum outer diameter of the shaft assembly is also limited. Furthermore, the deflectable element itself cannot be a hollow shell to accommodate all the required items, as it needs to have a sufficient amount of structure to support the elements it houses and to push the catheter through the blood vessel.

[0037] Embodiments of the present invention address the aforementioned problems by providing a catheter with a shaft assembly having a deflectable segment having a plurality of lumens longitudinally disposed within the deflectable segment. The deflectable segment has a maximum diameter (e.g., 3 mm), which allows the deflectable segment to fit into the blood vessels it is designed to traverse, and imparts the flexibility required for its traversal of these vessels. In some embodiments, the diameter of the deflectable segment is 2.67 mm or less.

[0038] The size and number of lumens are limited to ensure that the deflectable segment is robust enough to support its contained elements (e.g., mechanical elements for controlling the deflection of the deflectable segment and / or deploying and controlling the distal end assembly, such as a basket or balloon, on which electrodes are disposed) and is successfully guided through the blood vessel.

[0039] Electrodes located at the distal end are coupled to the control console via multiple electrically shielded cables, each cable serving a set of electrodes, and each cable is housed in a corresponding cavity within a separate cavity, while mechanical and other components are housed in other cavities. Each cable is electrically coupled to a connector (which reversibly connects to the control console) and the corresponding set of electrodes. Each cable comprises a bundle of individually insulated wires, each wire connected to a corresponding electrode in its respective set. Housed the cables and mechanical components in separate cavities, allowing the mechanical components to operate freely and facilitating the isolation of the cables from problematic electrostatic discharge that would result from the movement of the mechanical components.

[0040] Dividing electrode wires into multiple cables may seem counterintuitive at first glance, as a single cable typically has a smaller cross-sectional area than the combined cross-sectional area of ​​individual cables. However, dividing the wires connecting the electrodes to the control console into multiple cables provides greater mechanical flexibility than a single, larger cable and offers overall packaging efficiency that allows the space for mechanical components and wires to be constrained by the aforementioned deflectable segments.

[0041] The deflectable segment may include any suitable number of lumens of any suitable size. In some embodiments, the deflectable segment includes a central lumen surrounded by eight peripheral lumens. The central lumen may have any suitable diameter, and in an example embodiment, it has a diameter of about 1 mm. The peripheral lumens may have any suitable diameter, and in an example embodiment, each of the peripheral lumens has a diameter of about 0.56 mm. The central lumen may contain mechanical elements for deploying and controlling distal end assemblies (such as baskets or balloons). In other embodiments, the central lumen may be reserved for one or more other elements, such as, but not limited to, flushing tubing, other lines, and / or fiber optic cables. Both of the peripheral lumens may each include a resilient elongated member, such as a flexible tube. The two resilient elongated members define a preferred bending plane of the deflectable segment. The other two of the peripheral lumens may include mechanical elements (such as rods or wires) for controlling the deflection of the deflectable segment at the distal end of the shaft.

[0042] The remaining peripheral lumen can be used for wiring four electrically shielded cables. Each of the cables may include insulated wire bonded to a plastic tape surrounded by an electrical shield, which is then surrounded by an insulating sheath. Each cable may include any suitable number of insulated wires. In some embodiments, each cable includes thirty insulated wires, such that a total of 120 electrodes located at the distal end can be connected to the control console via a shaft assembly. Each cable may have any suitable outer diameter to allow sufficient freedom of movement within its lumen so that the insulated wires do not break when the deflectable section is deflected. In an example embodiment, the outer diameter of the cable may be from 0.4 mm to 0.5 mm.

[0043] System Description

[0044] References incorporated herein by reference shall be considered an integral part of this application, except that, in respect of any term defined in those incorporated references in a manner that contradicts the definitions express or implied in this specification, only the definitions in this specification shall be considered.

[0045] Now for reference Figure 1 This is a schematic illustration of an electroanatomical mapping system 20 according to an embodiment of the present invention. The electroanatomical mapping system 20 includes a catheter 40 configured for insertion into a body portion of a living subject (e.g., patient 28). A physician 30 navigates the catheter 40 (e.g., a basket catheter manufactured by Biosense Webster, Inc. of Irvine, CA, USA) (shown in detail in illustration 45) to a target location in the heart 26 of patient 28. The catheter 40 includes a shaft assembly 21 having a proximal end 29 and a distal end 33. The distal end 33 includes a deflectable segment 22. The physician 30 navigates the catheter 40 by manipulating the deflectable segment 22 of the catheter 40 and / or deflecting it from a sheath 23 using a manipulator 32 near the proximal end 29 of the shaft assembly 21. In the embodiment seen in illustration 25, the physician 30 uses the catheter 40 to perform electroanatomical mapping of the cardiac chambers.

[0046] The conduit 40 includes a plurality of electrodes 48 disposed at its distal end 33. In some embodiments, the distal end 33 of the shaft assembly 21 includes an assembly 35 (e.g., a basket assembly) on which the electrodes 48 are disposed. The conduit 40 includes an elongated member 37 coupled to an assembly adjacent to the sensor 50B, as described in more detail below. The elongated member 37 is typically a tube disposed within a lumen of a deflectable section. The elongated member 37 is typically controlled via a manipulator 32 to deploy the assembly 35 and to change the ellipticity of the assembly 35 according to longitudinal displacement of the elongated member 37 relative to the deflectable section. Reference Figure 3-5The slender member 37 is described in more detail.

[0047] By way of example only, the embodiments described herein primarily relate to basket-type distal end-effector assembly 35. In alternative embodiments, the disclosed technology can be used with balloon-based distal end-effector assemblies or any other suitable type of distal end-effector assembly (such as, for example, flower-shaped distal end-effector assemblies, for example, but not limited to, those based on those manufactured by Biosense Webster, Inc.). or Used together with catheters.

[0048] The catheter 40 is inserted through the sheath 23 in a folded configuration and only returns to its intended functional shape after the catheter 40 is withdrawn from the sheath 23. By including the catheter 40 in the folded configuration, the sheath 23 also serves to minimize vascular trauma along its route to the target location.

[0049] The conduit 40 incorporates a magnetic sensor 50A (see illustration 45) at the distal edge of the deflectable section 22 (i.e., at the proximal edge of the basket assembly 35). Typically, although not strictly necessary, sensor 50A is a triaxial sensor (TAS). A second magnetic sensor 50B may be included in the distal edge of the basket assembly 35. By way of example only, sensor 50B may be a uniaxial sensor (SAS), a biaxial sensor (DAS), or a triaxial sensor (TAS).

[0050] The conduit 35 further includes a plurality of expandable ridges 55, which may be mechanically flexible, with electrodes 48 coupled to each of the expandable ridges. Assembly 35 may include any suitable number of electrodes 48. In some embodiments, assembly 35 may include ten ridges 55 and 120 electrodes, with 12 electrodes disposed on each ridge 55. A first end of each ridge 55 is connected to a distal end of the shaft assembly 21, and a second end of each ridge 55 is connected to a distal end of the elongated member 37.

[0051] The actual basket assembly 35 structure can vary. For example, the expandable ridge 55 can be made of a printed circuit board (PCB) or shape memory alloy. Magnetic sensors 50A and 50B, along with electrode 48, are connected to various drive circuits in the control console 24 via wires traveling through the shaft assembly 21. (Reference) Figure 3-5 Let's discuss the route in more detail.

[0052] In some embodiments, system 20 includes a magnetic sensing subsystem to estimate the ellipticity of the basket assembly 35 of catheter 40 and its elongation / retraction state within the heart chambers of heart 26 by estimating the elongation of the basket assembly 35 from the distance between sensors 50A and 50B. Patient 28 is placed in a magnetic field generated by a pad containing a magnetic field generator coil 42 driven by unit 43. The magnetic field generated by coil 42 generates signals indicating position and / or orientation in sensors 50A and 50B. The generated signals are transmitted to console 24 and become corresponding electrical inputs to processing circuitry 41. Processing circuitry 41 uses these signals to calculate the elongation of basket assembly 35 and estimates the ellipticity and elongation / retraction state of the basket assembly based on the calculated distance between sensors 50A and 50B.

[0053] Orientation and / or orientation sensing methods using external magnetic fields and magnetic sensors (such as the 50A and 50B) are implemented in various medical applications, such as those produced by Biosense-Webster. The system is implemented and described in detail in U.S. Patents 5,391,199, 6,690,963, 6,484,118, 6,239,724, 6,618,612 and 6,332,089, PCT Patent Publication WO96 / 05768, and U.S. Patent Application Publications 2002 / 0065455A1, 2003 / 0120150A1 and 2004 / 0068178A1, the disclosures of which are incorporated herein by reference.

[0054] Processing circuitry 41 (typically part of a general-purpose computer) is further connected via suitable front-end and interface circuitry 44 to receive signals from surface electrodes 49. Processing circuitry 41 is connected to surface electrodes 49 via wires that pass through cable 39 and extend to the chest of patient 28.

[0055] The conduit 40 includes a connector 47 disposed at the proximal end 29 of the manipulator 32 for coupling to the processing circuit 41.

[0056] In one embodiment, processing circuitry 41 further receives various spatial and electrophysiological signals from electrode 48 via interface circuitry 44, and generates an electroanatomical mapping 31 of the cavity in response to information contained in these signals. During and / or after the procedure, processing circuitry 41 may display the electroanatomical mapping 31 on display 27.

[0057] The processing circuit 41 is typically programmed with software to perform the functions described herein. This software may be downloaded electronically to a computer via a network, or alternatively or additionally set and / or stored on a non-transitory tangible medium (such as magnetic storage, optical storage, or electronic storage).

[0058] Figure 1 The exemplary illustrations shown are chosen solely for the sake of conceptual clarity. For the sake of simplicity and clarity, Figure 1 Only elements relevant to the technology disclosed in this invention are shown. System 20 typically includes additional modules and elements that are not directly related to the technology disclosed in this invention, and therefore, these additional modules and elements are derived from... Figure 1 The corresponding descriptions are intentionally omitted. The elements of system 20 and the methods described herein can be further applied, for example, to control the ablation of tissues of the heart 26.

[0059] See now Figure 2 , Figure 2 for Figure 1 A transverse cross-sectional view of the deflectable segment 22 of the conduit 40.

[0060] The deflectable segment 22 includes a lumen 60 that travels longitudinally therein. In some embodiments, the deflectable segment 22 is made of an outer portion 62 and an inner portion 64 separated by a braided layer 66. The inner portion 64 includes the lumen 60 disposed therein. The braided layer 66 is used to provide torque transmission between the proximal end 29 and the distal end 33 of the catheter 40. In other embodiments, the deflectable segment 22 is formed as a single segment without the braided layer 66.

[0061] The outer portion 62 and the inner portion 64 can be formed of any suitable biocompatible material, such as flexible biocompatible plastics. In some embodiments, the outer portion 62 and the inner portion 64 can be formed of 80% polyether block amide (PEBA) and 20% BaSO4 (barium sulfate). The braided layer 66 can be any suitable wire, such as, but not limited to, flat wire braids. The braided layer 66 can have any suitable dimensions. In an example embodiment, the braided layer 66 has an inner diameter of 2.34 mm and a thickness of 0.076 mm. The deflectable segment 22 typically has an outer diameter of less than 3 mm. In an example embodiment, the deflectable segment 22 has an outer diameter of 2.67 mm.

[0062] The deflectable segment 22 may include any suitable number of lumens 60. In addition, the lumens 60 may have any suitable size and may be arranged in any suitable manner within the deflectable segment 22. Figure 2The illustrated lumen 60 includes a central lumen 60 surrounded by eight smaller lumens 60. This particular arrangement can be useful when one or more elements require a larger lumen 60. In the example embodiment, the central lumen 60 has a diameter of approximately 1 mm, and the other lumens 60 have a diameter of approximately 0.56 mm.

[0063] See now Figure 3 The image is Figure 2 A transverse cross-sectional view of the deflectable segment 22, whose lumen is loaded with various components. The conduit 40 includes multiple cables 68, with corresponding cables 68 disposed in corresponding lumens of lumens 60-3, 60-5, 60-7, and 60-9. Each cable 68 is electrically coupled to a connector 47. Figure 1 ) and the corresponding group of electrodes 48 ( Figure 1 In some implementations, the outer diameter of cable 68 is less than 0.5 mm. (Reference) Figure 5 Describe cable 68 in more detail. Figure 3 Four cables are shown disposed within the lumen 60. In some embodiments, the conduit 40 may include two, three, or even more than four cables 68 disposed within the lumen 60.

[0064] In some embodiments, the conduit 40 includes an elongated member 37 disposed in a lumen 60-1, and corresponding elongated members 70 disposed in respective lumens of lumens 60-2, 60-6. The elongated members 37, 70 are connected to the distal end 33 of the shaft assembly 21 and to the manipulator 32. Figure 1 The actuator is configured to actuate the distal end 33 via elongated members 37, 70, as described in more detail below.

[0065] The manipulator 32 is configured to deploy and adjust the assembly 35 of the conduit 40 via the elongated member 37, which is moved longitudinally relative to the deflectable section 22. Figure 1 In some embodiments, the elongated member 37 can be a tube or rod made of any suitable material and having any suitable diameter and thickness. In an example embodiment, the elongated member 37 is formed from a polyimide tube having an outer diameter of approximately 1 mm.

[0066] Manipulator 32 is configured to change the orientation of the deflectable segment 22 at the distal end 33 via at least one of the elongated members 70. The elongated members 70 are typically attached to the distal end 33 (e.g., to the distal end of the deflectable segment 22) such that pulling or pushing the elongated members 70 with manipulator 32 laterally deflects the deflectable segment 22. Conduit 40 may include more than two elongated members 70 to provide greater control over the deflection of the deflectable segment 22. In some embodiments, each elongated member 70 may be a tube, rod, or wire made of any suitable material and having any suitable diameter and thickness. In some embodiments, each elongated member 70 is surrounded by a compression coil in the proximal region of the deflectable segment 22, which is secured to the deflectable segment 22 in a compressed state. When the elongated member 70 is pulled, the compression coil resists compression in the deflectable segment 22 and prevents the deflectable segment 22 from becoming excessively wavy or loose. In the example embodiment, each elongated member 70 is formed of stainless steel or any other suitable material having an outer diameter of approximately 0.18 mm. As used herein, the term “about” or “approximately” for any numerical value or range indicates that a portion or assembly of components is permitted to perform suitable dimensional tolerances for their intended purpose as described herein. More specifically, “about” or “approximately” may refer to a range of ±20% of the enumerated values, for example, “about 90%” may refer to a value range of 71% to 99%. The conduit 40 includes two respective resilient elongated members 72 disposed in corresponding lumens within lumens 60-2, 60-6. The two resilient elongated members 72 define a preferred bending plane of the deflectable segment 22. In the example embodiment, the elongated members 72 are formed of polyamide, such as that from Evonik Resources Efficiency GmbH of Essen Germany. CARE, having an inner diameter of 0.3 mm and an outer diameter of 0.56 mm. In other embodiments, the elongated member 72 may be formed of any other suitable material, such as polyimide, polyetheretherketone (PEEK), or polyethersulfone (PESU). An example of a handle used as the manipulator 32 can be found in U.S. Patent 9,050,010 and priority to U.S. Provisional Patent Application Serial No. 62 / 903337 (BIO6216USPSP1), filed September 2019, all of which are incorporated herein by reference, with copies provided in the appendix.

[0067] In other embodiments, lumens 60-1, 60-2, 60-4, 60-6, and 60-8 may include, for example, but not limited to, flushing tubes and / or optical fibers, any suitable element.

[0068] Figure 4 for Figure 1 A cross-sectional view of the deflectable segment 22 of the conduit 40. Figure 4A lumen 60 is shown, which contains a deflectable section 22 with elongated members 37 and 72. Figure 4 Cable 68 or slender member 70 is not shown.

[0069] See now Figure 5 It is included in Figure 3 A cross-sectional view of one of the cables 68 in the deflectable segment 22.

[0070] Each cable 68 comprises (for example, at least 20 or 30) bundles of individually insulated wires 74 (for simplicity, only some of the wires 74 are labeled). See above. Figure 3 Each cable 68 is electrically connected to connector 47. Figure 1 ) and the corresponding group of electrodes 48 ( Figure 1 Each wire 74 is connected to a corresponding one of the electrodes 48 in the corresponding group. The conductor of the wire 74 can be formed of any suitable conductive material, such as, but not limited to, copper alloy wire. In an example embodiment, the outer diameter of the conductor is 0.032 mm. The insulator of the wire 74 can be formed of any suitable material, such as, but not limited to, polyurethane, polyimide, or any thin enamel insulator. In an example embodiment, the insulator has an outer diameter of 0.042 mm. If the conduit 40 includes 120 electrodes 48, the conduit 40 typically includes four cables, each of which includes thirty wires 74. For an Octara conduit with 50 electrodes, the conduit 40 includes two cables 68, each of which includes twenty-five wires 74. Insulated wires connecting the sensor 50 to the processing circuit 41 may also be included in one or more of the cables 68.

[0071] Each cable 68 includes a strip 76 (e.g., a plastic strip) that is wrapped around a bundle of insulated wires 74 below the shield 78 (described below). The strip 76 holds the bundle of wires 74 together and adds an obstacle between the wires 74 and the shield 78, which can damage the insulation of the wires 74.

[0072] Each wire 68 includes an electrical shield 78 surrounding the wire harness and tape 76. The shield 78 interrupts electrostatic charges. The electrical shield 78 may include any suitable shielding material. In some embodiments, the shield 78 includes a non-overlapping wire spiral portion of a tin-copper alloy with a thickness of about 0.025 mm.

[0073] Each cable 68 also includes an electrical insulating sheath 80 that surrounds the electrical shield 78 and is sized to allow the respective cable 68 to pass through the respective cavity 60. Figure 2-4Longitudinal movement within the cavity 60. By way of example only, the electrical insulation sheath 80 may include any one or more of the following: polytetrafluoroethylene (PTFE); or perfluoroalkoxyalkane (PFA) to allow the cable 68 to slide smoothly within the cavity 60. In an example embodiment, the electrical insulation sheath 80 has an outer diameter of about 0.4 mm and a thickness of about 0.03 mm. The electrical insulation sheath 80 serves to hold the shield 78 together so that the shield 78 does not clump together as the cable 68 slides back and forth within the cavity 60. The cable 68 slides within the cavity 60 but may be secured at the distal end of the deflectable segment 22.

[0074] For clarity, the various features of the invention described in the context of individual embodiments may also be provided in combination in a single embodiment. Conversely, for brevity, the various features of the invention described in the context of individual embodiments may also be provided individually or in any suitable sub-combination.

[0075] The above embodiments are cited by way of example, and the invention is not limited to the specific details shown and described above. Rather, the scope of the invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which should 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 catheter configured for insertion into a body portion of a living subject, and comprising: A shaft assembly having a proximal end and a distal end, the distal end including a deflectable section comprising a longitudinally traveling lumen within the deflectable section, the shaft assembly further comprising: An inner portion and an outer portion, the inner portion including the lumen, and the outer portion disposed around the outer circumference of the inner portion; and A braided layer disposed between the inner portion and the outer portion; Multiple electrodes are disposed at the distal end of the shaft assembly; A connector disposed at the proximal end of the shaft assembly for coupling to processing circuitry; Multiple cables are disposed in a first corresponding cavity within the lumen, each cable being electrically coupled to the connector and a corresponding set of electrodes, wherein each cable includes: A bundle of individually insulated wires, each wire connected to a corresponding one of the electrodes in the corresponding group; Electrical shielding material surrounding the wire harness; and An electrically insulating sheath surrounds the electrical shield and is sized to allow longitudinal movement of the respective cable within the first respective cavity; A corresponding first elongated member is disposed in a second corresponding cavity within the cavity and is connected to the distal end; A manipulator, connected to the first elongated member and configured to actuate the distal end via the first elongated member, wherein the manipulator is configured to change the orientation of the deflectable segment via at least one of the first elongated members; and Two corresponding elastic second elongated members are disposed in a third corresponding cavity within the cavity, and the two corresponding elastic second elongated members define a preferred bending plane of the deflectable segment.

2. The catheter of claim 1, wherein the distal end includes an assembly having the plurality of electrodes disposed thereon, at least one of the first elongated members being coupled to the assembly, and the manipulator being configured to deploy the assembly via the at least one first elongated member.

3. The catheter according to claim 1, wherein the deflectable section has an outer diameter of less than 3 mm.

4. The conduit of claim 3, wherein each of the cables has an outer diameter of less than 0.5 mm and comprises at least twenty insulated wires.

5. The conduit of claim 4, wherein the conduit comprises at least three cables of the cable.

6. The conduit of claim 3, wherein each of the cables has an outer diameter of less than 0.5 mm and comprises at least thirty insulated wires.

7. The conduit of claim 6, wherein the conduit comprises at least three cables of the cable.

8. The conduit of claim 1, wherein each respective cable includes a strip wrapped around a bundle of insulating wires beneath the shield.

9. The conduit of claim 1, wherein the electrically insulating sheath comprises any one or more of the following: polytetrafluoroethylene (PTFE); or perfluoroalkoxyalkane (PFA).

10. The conduit of claim 1, wherein the deflectable segment comprises a thermoplastic elastomer.

11. The conduit according to claim 1, wherein the electrical shielding comprises a non-overlapping wire spiral portion.

12. The conduit of claim 11, wherein the electrical shield comprises a tin-copper alloy.

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