Patent Description:
Electrode catheters have been in common use in medical practice for many years. They are used to stimulate and map electrical activity in the heart and to ablate sites of aberrant electrical activity. In use, the electrode catheter is inserted into a chamber of the heart. Once the catheter is positioned, the location of aberrant electrical activity within the heart is then located.

One location technique involves an electrophysiological mapping procedure whereby the electrical signals emanating from the conductive endocardial tissues are systematically monitored and a map is created of those signals. By analyzing that map, the physician can identify the interfering electrical pathway. A conventional method for mapping the electrical signals from conductive heart tissue is to percutaneously introduce an electrophysiology catheter (electrode catheter) having mapping electrodes mounted on its distal extremity. The catheter is maneuvered to place these electrodes in contact with or in close proximity to the endocardium. By monitoring the electrical signals at the endocardium, aberrant conductive tissue sites responsible for the arrhythmia can be pinpointed.

For mapping, it is desirable to have a relatively small mapping electrode. 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 of the mapping arrangement be in close proximity to each other and that they be similar in size to produce more accurate and useful electrograms.

Once the origination point for the arrhythmia has been located in the tissue, the physician uses an ablation procedure to destroy the tissue causing the arrhythmia in an attempt to remove the electrical signal irregularities and restore normal heart beat or at least an improved heartbeat. Successful ablation of the conductive tissue at the arrhythmia initiation site usually terminates the arrhythmia or at least moderates the heart rhythm to acceptable levels.

Multi-electrode catheters come in various forms, including, flower catheters, balloon catheters and basket catheters, by way of example only. Some of the catheters may have tens of electrodes and some in excess of one-hundred electrodes. These multi-electrode catheters help streamline and speedup the mapping or ablation procedure. However, as the number of electrodes increases so does the complexity of coupling the electrodes with a control unit of the catheter via a catheter shaft, which has limited dimensions due to the inherent limited size of the blood vessels through which the catheter must traverse.

<CIT>, describes a multiplexed medical carrier which provides for sensing one or more patient parameters and/or delivering energy via separately identifiable effectors. The carrier includes a body and at least two electrical conductors coupled with at least two effectors. Effectors may be any combination of sensors, actuators or both. Sensors may measure such parameters as pressure, oxygen content, volume, conductivity, fluid flow rate, or any other chemical or physical parameters. Actuators may be used, for example, to pace a heart, stimulate muscle or neural tissue, broadcast ultrasonic energy, emit light, heat or other forms of radiation, or deliver any form of energy or substance.

<CIT>, describes a catheter including a body portion having a distal end and a proximal end. A plurality of lumens is 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 being positioned between the heating element and the distal end of the body portion. Heating-element wires are connected to the heating element and extend from the heating element to the proximal end of the body portion in one of the lumens of the catheter, and temperature-sensor wires are connected to the temperature sensor and extend in a twisted configuration from the temperature sensor to the proximal end of the body portion in one of the lumens of the catheter. The heating-element wires are connectable to a control unit and carry an activation signal from the control unit to the heating element to activate the heating element. The temperature-sensor wires are connectable to a processing unit and carry a temperature-sensor signal from the temperature sensor to the processing unit for processing.

<CIT>, describes a catheter assembly for an intravascular ultrasound system includes a catheter, an imaging core, and a shield-coupling capacitor. The catheter defines a lumen extending along a longitudinal length of the catheter. The imaging core is configured and arranged for inserting into the lumen. The imaging core includes a rotatable driveshaft, one or more transducers, one or more conductors, and a conductive shield. The one or more transducers are mounted to the rotatable driveshaft. The one or more conductors are coupled to the one or more transducers and extend along the driveshaft. The conductive shield is disposed around the one or more conductors. The shield-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 shield-coupling capacitor is configured and arranged for coupling to a system ground.

<CIT> describes a force-sensing catheter for diagnosing or treating the vessels found within a body or body space includes a center strut that is bonded, preferably thermally, along its longitudinal axis with the thermoplastic tubular member within which it is housed. The tubular member preferably has three layers: an inner layer, a braided layer and an outer layer. One or more semiconductor or metallic foil strain gauges are affixed to the center strut in order to provide a measure of the bending and torsional forces on the distal tip of the catheter. Temperature compensation is achieved by having a temperature sensor near the strain gauges and calibrating the catheter over a range of temperatures.

<CIT> discloses an irrigated balloon catheter with support spines and variable shape. An irrigated balloon catheter, includes a balloon carrying contact electrodes, wherein a user can vary the balloon's configuration by manipulating an elongated expander that extends along the catheter and through the balloon's interior, with its distal end coupled to a distal end of the balloon. The expander may pass through an irrigation lumen to save on space within the catheter, and the expander itself may be hollow in providing a lumen for cables or lead wires. The expander may include flexure slits for increased flexibility. The distal end of the balloon includes a housing for components, e.g., a position sensor. The distal end of the balloon and the manner by which the balloon membrane is attached to the housing present a generally flat atraumatic surface suitable for direct head-on contact with tissue. Longitudinal spines extend along the outer surface of the balloon to provide support.

<CIT> discloses a catheter with high density electrode spine array. Disclosed is a catheter adapted or high density mapping and/or ablation of tissue surface has a distal electrode matrix having a plurality of spines arranged in parallel configuration on which a multitude of electrodes are carried in a grid formation for providing uniformity and predictability in electrode placement on the tissue surface. The matrix can be dragged against the tissue surface upon deflection (and/or release of the deflection) of the catheter. The spines generally maintain their parallel configuration and the multitude of electrodes generally maintain their predetermined relative spacing in the grid formation as the matrix is dragged across the tissue surface in providing very high density mapping signals. The spines may have free distal ends, or distal ends that are joined to form loops for maintaining the spines in parallel configuration.

<CIT> discloses an intracardiac defibrillation catheter. Disclosed is a defibrillation catheter that is insertable along a guide wire into a target site in the inside of a cardiac cavity and that can assuredly prevent a short circuit between a first lead wire group and a second lead wire group. The defibrillation catheter comprises a multi-lumen tube, a first DC electrode group, a second DC electrode group, a first lead wire group made up of lead wires connected to each of constituent electrodes of the first DC electrode group, and a second lead wire group made up of lead wires connected to each of constituent electrodes of the second DC electrode group; and applies voltages between the first DC electrode group and the second DC electrode group. The multi-lumen tube has a center lumen through which the guide wire is insertable, and a sub-lumen and a sub-lumen disposed so as to face each other with the center lumen interposed therebetween. The first lead wire group extends in the sub-lumen, and the second lead wire group extends in the sub-lumen.

<CIT> discloses a catheter with an electromagnetic guidance sensor. The disclosure relates to an electrophysiology catheter (an electrode catheter) having an electromagnetic sensor designed internally into the top portion. The catheter is a size <NUM> French or <NUM> French of metal braided construction with preferably three lumens. The catheter has a deflectable tip utilizing an offset lumen with a puller wire, a non-compressible coil in the body section, and a compressible TEFLON sheath in the tip section. The electromagnetic sensor is mounted internally in the catheter tip by a combination of a hole drilled in the three lumen tip, and a hollow bridging that covers the electromagnetic sensor and connects the tip electrode to the catheter shaft. The tip electrode is secured to the end of the bridging tube by an etched TEFLON ring which mates the electrode stem to the inside of the ring.

There is provided in accordance with an embodiment of the present disclosure, a catheter configured to be inserted into a body part of a living subject, and including a shaft assembly having a proximal end and a distal end, which includes a deflectable segment including lumens having a diameter of about <NUM> running longitudinally in the deflectable segment, multiple 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 first respective ones of the lumens, each cable electrically coupled to the connector and a respective group of the electrodes, wherein each cable includes a bundle of individually insulated wires, each wire connected to a respective one of the electrodes in the respective group, an electrical shielding surrounding the bundle, and an electrically insulating jacket having an outside diameter of about <NUM> and a thickness of about <NUM>, the electrically insulating jacket surrounding the electrical shielding and sized to allow longitudinal movement of the respective cable within the respective lumen, and tape which is wrapped around the bundle of insulated wires underneath the shielding. The catheter also includes respective elongated members disposed in second respective ones of the lumens, and connected to the distal end, and a manipulator connected to the elongated members and configured to actuate the distal end via the elongated members.

Further in accordance with an embodiment of the present disclosure the manipulator is configured to change an orientation of the deflectable segment via at least one of the elongated members.

Still further in accordance with an embodiment of the present disclosure the distal end includes an assembly on which the multiple electrodes are disposed, at least one of the elongated members being coupled to the assembly, the manipulator being configured to deploy the assembly via the at least one elongated member. Additionally, in accordance with an embodiment of the present disclosure the catheter includes two respective resilient elongated members disposed in third respective ones of the lumens, the two resilient elongated members defining a plane of preferential bending of the deflectable segment.

Moreover, in accordance with an embodiment of the present disclosure the deflectable segment has an outside diameter of less than <NUM>.

Further in accordance with an embodiment of the present disclosure each of the cables has an outside diameter of less than <NUM> and includes at least twenty insulated wires.

Still further in accordance with an embodiment of the present disclosure the catheter includes at least three of the cables.

Additionally, in accordance with an embodiment of the present disclosure each of the cables has an outside diameter of less than <NUM>.

<NUM> and includes at least thirty insulated wires.

Moreover, in accordance with an embodiment of the present disclosure the catheter includes at least three of the cables.

Still further in accordance with an embodiment of the present disclosure the electrically insulating jacket includes any one or more of the following polytetrafluoroethylene (PTFE), or perfluoroalkoxy alkane (PFA).

Additionally, in accordance with an embodiment of the present disclosure the deflectable segment includes a thermoplastic elastomer.

Moreover, in accordance with an embodiment of the present disclosure the electrical shielding includes a non-overlapping wire spiral.

Further in accordance with an embodiment of the present disclosure the electrical shielding includes a tinned-copper alloy.

As previously discussed, multi-electrode catheters come in various forms, including, flower catheters, balloon catheters and basket catheters, by way of example only. Some of the catheters may have tens of electrodes and some in excess of one hundred electrodes. These multi-electrode catheters help streamline and speedup the mapping or ablation procedure. However, as the number of electrodes increases so does the complexity of coupling the electrodes with a control unit of the catheter via a catheter shaft assembly, which has limited dimensions due to the inherent limited size of the blood vessels through which the catheter must traverse. Additionally, if the interior components of the catheter shaft assembly are too thick, the shaft assembly may not have the required flexibility it needs to traverse the blood vessels even if the shaft assembly itself is narrower than the blood vessels.

Compounding the complexity of coupling the electrodes to the control unit via the catheter shaft assembly is the presence of other items in the shaft assembly such as mechanical elements for controlling the deflection of a deflectable segment of the distal end of the shaft assembly, and/or deploying and controlling a distal end assembly, such as a basket or balloon, on which the electrodes are disposed. Other elements such as irrigation tubing may also be disposed in the shaft assembly.

Another problem associated with coupling the electrodes to the control unit is that as the catheter deflects, electrical noise due to electrostatic discharge from the insulation of the wires is generated on the wires coupling the electrodes to the control unit. Since the electrical activity sensed by the electrodes is in the order of millivolts with microvolt resolution, the noise generated in the wires may significantly impact the accuracy of the sensed electrical activity.

An additional problem associated with coupling the electrodes to the control unit is that the wires need a certain amount of freedom of motion within the deflectable segment, as otherwise the wires may break when the deflectable segment is deflected. Therefore, the wires require space in the deflectable segment to provide this freedom of motion.

As mentioned above the available space in the deflectable segment is used for many items and the maximum outside diameter of the shaft assembly is also limited. In addition, 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 in order to provide support for the elements it contains as well as for pushing the catheter through the blood vessels.

Embodiments of the present invention solve the above problems by providing a catheter with a shaft assembly having a deflectable segment with a plurality of lumens disposed longitudinally in the deflectable segment. The deflectable segment has a maximum diameter (for example, <NUM>), which allows the deflectable segment to fit in the blood vessels it was designed to traverse, as well as giving the deflectable segment the flexibility it needs to traverse those blood vessels. In some embodiments, the diameter of the deflectable segment is <NUM> or less.

The size and number of lumens are limited to ensure that the deflectable segment is strong enough to support the elements it contains (e.g., mechanical elements for controlling the deflection of the deflectable segment, and/or deploying and controlling a distal end assembly, such as a basket or balloon, on which electrodes are disposed) and to be guided successfully through the blood vessels.

The electrodes disposed at the distal end are coupled to a console via multiple electrically-shielded cables, each cable serving a group of electrodes, and each cable being disposed in a respective one of the lumens, while mechanical and other elements are disposed in other lumens. Each cable is electrically coupled to a connector (which reversibly connects to the console) and a respective group of the electrodes. Each cable includes a bundle of individually insulated wires with each wire being connected to a respective one of the electrodes in the respective group. Disposing the cables and mechanical elements in separate lumens allows the mechanical elements to operate freely and helps isolate the cables from problematic static that would be caused by movement of the mechanical elements.

Dividing the electrode wires among multiple cables may at first appear to be counterintuitive, as a single cable generally has a smaller cross-sectional area than the combined cross-sectional areas of separate cables. However, dividing the wires connecting the electrodes with the console into multiple cables provides a greater mechanical flexibility than a single larger cable and provides an overall packing efficiency which allows space for the mechanical elements and the wires subject to the structural limits of the deflectable segment mentioned above.

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 example embodiments has a diameter of about <NUM>. The peripheral lumens may have any suitable diameter, and in example embodiments each of the peripheral lumens has a diameter of about <NUM>. The central lumen may contain a mechanical element for deploying and controlling the distal end assembly, such as a basket or balloon. In other embodiments, the central lumen may be reserved for another element or elements, for example, but not limited to, irrigation tubing, other wiring, and/or optic cables. Two of the peripheral lumens may each include a resilient elongated member, for example, resilient tubes. The two resilient elongated members define a plane of preferential bending of the deflectable segment. Another 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.

The remaining peripheral lumens may be used for routing four electrically shielded cables. Each of the cables may include insulated wires bound together with a plastic tape, which is surrounded with an electrical shielding, which is in turn surrounded with an insulated jacket. Each of the cables may include any suitable number of insulated wires. In some embodiments, each cable includes thirty insulated wires so that four cables may in total connect <NUM> electrodes disposed at the distal end with the console via the shaft assembly. Each cable may have any suitable outer diameter to allow the cable sufficient freedom of movement in its lumen so that when the deflectable segment is deflected the insulated wires do not break. In example embodiments, the outer diameter of the cable may be <NUM> to <NUM>.

Reference is now made to <FIG>, which is a schematic, pictorial illustration of an electro-anatomical medical mapping system <NUM>, in accordance with an embodiment of the present invention. The electro-anatomical mapping system <NUM> includes a catheter <NUM> configured to be inserted into a body part of a living subject (e.g., a patient <NUM>). A physician <NUM> navigates the catheter <NUM> (for example, a basket catheter produced Biosense Webster, Inc. of Irvine, CA, USA), seen in detail in inset <NUM>, to a target location in a heart <NUM> of the patient <NUM>. The catheter <NUM> includes a shaft assembly <NUM> having a proximal end <NUM> and a distal end <NUM>. The distal end <NUM> include the deflectable segment <NUM>. The physician <NUM> navigates the catheter <NUM> by manipulating the deflectable segment <NUM> of the catheter <NUM>, using a manipulator <NUM> near the proximal end <NUM> of the shaft assembly <NUM>, and/or deflection from a sheath <NUM>. In the embodiment seen in inset <NUM>, physician <NUM> uses catheter <NUM> to perform electro-anatomical mapping of a cardiac chamber.

The catheter <NUM> includes multiple electrodes <NUM> disposed at the distal end <NUM>. In some embodiments, the distal end <NUM> of the shaft assembly <NUM> includes an assembly <NUM> (e.g., a basket assembly) on which the electrodes <NUM> are disposed. The catheter <NUM> includes an elongated member <NUM> coupled to the assembly close to a sensor 50B, described in more detail below. The elongated member <NUM> is typically a tube that is disposed in a lumen of the deflectable segment. The elongated member <NUM> is generally controlled via the manipulator <NUM> to deploy the assembly <NUM> and change an ellipticity of the assembly <NUM> according to the longitudinal displacement of the elongated member <NUM> with respect to the deflectable segment. The elongated member <NUM> is described in more detail with reference to <FIG>.

Embodiments described herein refer mainly to a basket distal-end assembly <NUM>, purely by way of example. In alternative embodiments, the disclosed techniques can be used with a catheter having a balloon-based distal-end assembly or of any other suitable type of distal-end assembly, such as a flower-type distal end assembly, for example, but not limited to, based on a Pentaray® or Octaray® catheter produced by Biosense Webster, Inc.

Catheter <NUM> is inserted in a folded configuration, through sheath <NUM>, and only after the catheter <NUM> exits sheath <NUM> does catheter <NUM> regain its intended functional shape. By containing catheter <NUM> in a folded configuration, sheath <NUM> also serves to minimize vascular trauma on its way to the target location.

Catheter <NUM> may incorporate a magnetic sensor 50A, seen in inset <NUM>, at the distal edge of the deflectable segment <NUM> (i.e., at the proximal edge of basket assembly <NUM>). Typically, although not necessarily, sensor 50A is a Triple-Axis Sensor (TAS). A second magnetic sensor 50B may be included in a distal edge of the basket assembly <NUM>. Sensor 50B may be a Single-Axis Sensor (SAS), Double-Axis Sensor (DAS), or a Triple-Axis Sensor (TAS), by way of example only.

The assembly <NUM> further comprises multiple expandable spines <NUM>, which may be mechanically flexible, to each of which are coupled the electrodes <NUM>. The assembly <NUM> may include any suitable number of electrodes <NUM>. In some embodiments, the assembly <NUM> may include ten spines <NUM> and <NUM> electrodes, with <NUM> electrodes disposed on each spine <NUM>. First ends of the spines <NUM> are connected to the distal end of the shaft assembly <NUM> and second ends of the spines <NUM> are connected to the distal end of the elongated member <NUM>.

The actual basket assembly <NUM> structure may vary. For example, expandable spines <NUM> may be made of a printed circuit board (PCB), or of a shape-memory alloy. Magnetic sensors 50A and 50B and electrodes <NUM> are connected by wires running through shaft assembly <NUM> to various driver circuitries in a console <NUM>. The wiring is discussed in more detail with reference to <FIG>.

In some embodiments, system <NUM> comprises a magnetic-sensing subsystem to estimate an ellipticity of the basket assembly <NUM> of catheter <NUM>, as well as its elongation/retraction state, inside a cardiac chamber of heart <NUM> by estimating the elongation of the basket assembly <NUM> from the distance between sensors 50A and 50B. Patient <NUM> is placed in a magnetic field generated by a pad containing magnetic field generator coils <NUM>, which are driven by a unit <NUM>. The magnetic fields generated by coils <NUM> generate signals in sensors 50A and 50B, which are indicative of position and/or direction. The generated signals are transmitted to console <NUM> and become corresponding electrical inputs to processing circuitry <NUM>. The processing circuitry <NUM> uses the signals to calculate the elongation of the basket assembly <NUM>, and to estimate basket ellipticity and elongation/retraction state from the calculated distance between sensors 50A and 50B.

The method of position and/or direction sensing using external magnetic fields and magnetic sensors, such as 50A and 50B, is implemented in various medical applications, for example, in the CARTO® system, produced by Biosense-Webster, and is described in detail in <CIT>, <CIT>, <CIT>, <CIT>,<CIT> and <CIT>, in <CIT>, and in <CIT>, <CIT> and <CIT>.

Processing circuitry <NUM>, typically part of a general-purpose computer, is further connected via a suitable front end and interface circuits <NUM>, to receive signals from surface-electrodes <NUM>. Processing circuitry <NUM> is connected to surface-electrodes <NUM> by wires running through a cable <NUM> to the chest of patient <NUM>.

The catheter <NUM> includes a connector <NUM> disposed at the proximal end <NUM> of the manipulator <NUM> for coupling to the processing circuitry <NUM>.

In an embodiment, processing circuitry <NUM> additionally receives various spatial and electrophysiological signals from the electrodes <NUM> via interface circuits <NUM>, and generates an electroanatomic map <NUM> of the cavity responsively to information contained in these signals. During and/or following the procedure, processing circuitry <NUM> may display the electro-anatomical map <NUM> on a display <NUM>.

Processing circuitry <NUM> is typically programmed in software to carry out the functions described herein. The software may be downloaded to the computer in electronic form, over a network, for example, or it may, alternatively or additionally, be provided and/or stored on non-transitory tangible media, such as magnetic, optical, or electronic memory.

The example illustration shown in <FIG> is chosen purely for the sake of conceptual clarity. <FIG> shows only elements related to the disclosed techniques for the sake of simplicity and clarity. System <NUM> typically comprises additional modules and elements that are not directly related to the disclosed techniques, and thus are intentionally omitted from <FIG> and from the corresponding description. The elements of system <NUM> and the methods described herein may be further applied, for example, to control an ablation of tissue of heart <NUM>.

Reference is now made to <FIG>, which is a transverse cross-sectional view of the deflectable segment <NUM> of the catheter <NUM> of <FIG>.

The deflectable segment <NUM> includes lumens <NUM> running longitudinally in therein. In some embodiments the deflectable segment <NUM> is made from an outer portion <NUM> and an inner portion <NUM> separated by a braiding layer <NUM>. The inner portion <NUM> includes the lumens <NUM> disposed therein. The braiding layer <NUM> serves to provide torque transfer between the proximal end <NUM> and the distal end <NUM> of the catheter <NUM>. In other embodiments, the deflectable segment <NUM> is formed as a single portion without the braiding layer <NUM>.

The outer portion <NUM> and the inner portion <NUM> may be formed from any suitable biocompatible material, for example, a flexible biocompatible plastic or the like. In some embodiments, the outer portion <NUM> and the inner portion <NUM> may be formed from <NUM>% polyether block amide (PEBA) and <NUM>% BaSO4 (barium sulfate). The braiding layer <NUM> may be any suitable wire for example, but not limited to, a flat wire braid. The braiding layer <NUM> may have any suitable dimensions. In example embodiments, the braiding layer <NUM> has an inner diameter of <NUM> and a thickness of <NUM>. The deflectable segment <NUM> generally has an outside diameter of less than <NUM>. In example embodiments the deflectable segment <NUM> has an outside diameter of <NUM>.

The deflectable segment <NUM> may include any suitable number of the lumens <NUM>. Additionally, the lumens <NUM> may have any suitable size and be arranged in the deflectable segment <NUM> according to any suitable arrangement. The lumens <NUM> shown in <FIG> include a central lumen <NUM> surrounded by eight smaller lumens <NUM>. This particular arrangement may be useful when a larger lumen <NUM> is needed for one or more elements. In an example embodiment, the central lumen <NUM> has a diameter of about <NUM> and the other lumens <NUM> have a diameter of about <NUM>.

Reference is now made to <FIG>, which is a transverse cross-sectional view of the deflectable segment <NUM> of <FIG> with its lumens loaded with various elements. The catheter <NUM> includes a plurality of cables <NUM> with respective cables <NUM> disposed in respective ones of the lumens <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>. Each cable <NUM> is electrically coupled to the connector <NUM> (<FIG>) and a respective group of the electrodes <NUM> (<FIG>). In some embodiments, the outside diameter of the cables <NUM> is less than <NUM>. The cables <NUM> are described in more detail with reference to <FIG>. <FIG> shows four cables disposed in the lumens <NUM>. In some embodiments, the catheter <NUM> may include two, three or even more than four cables <NUM> disposed in the lumens <NUM>.

In some embodiments, the catheter <NUM> includes the elongated member <NUM> disposed in the lumen <NUM>-<NUM>, and respective elongated members <NUM> disposed in respective ones of the lumens <NUM>-<NUM>, <NUM>-<NUM>. The elongated members <NUM>, <NUM> are connected to the distal end <NUM> of the shaft assembly <NUM> and to the manipulator <NUM> (<FIG>), which is configured to actuate the distal end <NUM> via the elongated members <NUM>, <NUM>, as described in more detail below.

The manipulator <NUM> is configured to deploy and adjust the assembly <NUM> (<FIG>) of the catheter <NUM> via the elongated member <NUM>, by moving the elongated member <NUM> longitudinally with respect to the deflectable segment <NUM>. In some embodiments, the elongated member <NUM> may be a tube or rod comprised of any suitable material and having any suitable diameter and thickness. In example embodiments, the elongated member <NUM> is formed from a polyimide tube having an outside diameter of approximately <NUM>.

The manipulator <NUM> is configured to change an orientation of the deflectable segment <NUM> of the distal end <NUM> via at least one of the elongated members <NUM>. The elongated members <NUM> are generally connected to the distal end <NUM> (e.g., to the distal end of the deflectable segment <NUM>) so that pulling or pushing the elongated members <NUM> with the manipulator <NUM> deflects the deflectable segment <NUM> sideways. The catheter <NUM> may include more than two elongated members <NUM> in order to provide greater control of the deflection of the deflectable segment <NUM>. In some embodiments, each elongated member <NUM> may be a tube, rod or wire comprised of any suitable material and having any suitable diameter and thickness. In some embodiments, in a proximal region of the deflectable segment <NUM>, each elongated member <NUM> is surrounded with a compression coil which is secured to the deflectable segment <NUM> in a compressed state. When the elongated member <NUM> is pulled, the compression coil resists compression in the deflectable segment <NUM> and prevents the deflectable segment <NUM> from becoming too wavy or floppy. In example embodiments, each elongated member <NUM> is formed from stainless steel or any other suitable material, with an outside diameter of approximately <NUM>. The catheter <NUM> comprises two respective resilient elongated members <NUM> disposed in respective ones of the lumens <NUM>-<NUM>, <NUM>-<NUM>. The two resilient elongated members <NUM> define a plane of preferential bending of the deflectable segment <NUM>. In example embodiments, the elongated members <NUM> are formed from polyamide, such as VESTAMID® CARE of Evonik Resource Efficiency GmbH of Essen Germany with an inside diameter of <NUM>, and an outside diameter of <NUM>. In other embodiments, the elongated members <NUM> may be formed from any other suitable material, for example, polyimide, Polyether Ether Ketone (PEEK), or Polyethersulfone (PESU). One example of a handle for use as manipulator <NUM> can be found in <CIT> as well as the handle described and illustrated in <CIT> (BIO6216USPSP1) filed on in <CIT>.

In other embodiments, the lumens <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> may include any suitable elements for example, but not limited to irrigation tubes and/or optical fibers.

<FIG> is a cutaway view of the deflectable segment <NUM> of the catheter <NUM> of <FIG>. <FIG> shows the lumens <NUM> of the deflectable segment <NUM> loaded with the elongated member <NUM> and the elongated members <NUM>. <FIG> does not show the cables <NUM> or the elongated members <NUM>.

Reference is now made to <FIG>, which is a cross-sectional view of one of the cables <NUM> included in the deflectable segment <NUM> of <FIG>.

Each cable <NUM> includes a bundle of (e.g., at least <NUM> or <NUM>) individually insulated wires <NUM> (only some of the wires <NUM> have been labeled for the sake of simplicity). As mentioned above with reference to <FIG>, each cable <NUM> is electrically coupled to the connector <NUM> (<FIG>) and a respective group of the electrodes <NUM> (<FIG>). Each wire <NUM> is connected to a respective one of the electrodes <NUM> in the respective group. The conductor of the wires <NUM> may be formed from any suitable conducting material, for example, but not limited to, copper alloy wire. In example embodiments the outside diameter of the conductor is <NUM>. The insulator of the wires <NUM> may be formed from any suitable material, for example, but not limited to polyurethane, polyimide, or any thin enamel insulation. In example embodiments the insulator has an outside diameter of <NUM>. If the catheter <NUM> includes <NUM> electrodes <NUM>, the catheter <NUM> typically includes four cables, with each cable including thirty wires <NUM>. For an Octaray catheter with <NUM> electrodes, the catheter <NUM> include two cables <NUM>, with each cable including twenty-five wires <NUM>. Insulated wires connecting the sensors <NUM> to the processing circuitry <NUM> may also be included in one or more of the cables <NUM>.

Each cable <NUM> includes tape <NUM> (e.g., plastic tape) which is wrapped around the bundle of insulated wires <NUM> underneath a shielding <NUM> (described below). The tape <NUM> holds the bundle of wires <NUM> together and adds a barrier between the wires <NUM> and the shielding <NUM>, which could damage the insulators of the wires <NUM>.

Each cable <NUM> includes the electrical shielding <NUM> surrounding the bundle and tape <NUM>. The shielding <NUM> sheds electrostatic charges. The electrical shielding <NUM> may comprise any suitable shielding material. In some embodiments, the shielding <NUM> comprises a non-overlapping wire spiral of a tinned-copper alloy with a thickness of about <NUM>.

Claim 1:
A catheter (<NUM>) configured to be inserted into a body part of a living subject, and comprising:
a shaft assembly (<NUM>) having a proximal end (<NUM>) and a distal end (<NUM>), which comprises a deflectable segment (<NUM>) including lumens (<NUM>) running longitudinally in the deflectable segment, wherein the lumens have a diameter of about <NUM>;
multiple electrodes (<NUM>) disposed at the distal end of the shaft assembly;
a connector (<NUM>) disposed at the proximal end of the shaft assembly for coupling to processing circuitry (<NUM>);
a plurality of cables (<NUM>) disposed in first respective ones of the lumens, each cable electrically coupled to the connector and a respective group of the electrodes, wherein each cable comprises:
a bundle of individually insulated wires (<NUM>), each wire connected to a respective one of the electrodes in the respective group;
an electrical shielding (<NUM>) surrounding the bundle;
an electrically insulating jacket (<NUM>) surrounding the electrical shielding and sized to allow longitudinal movement of the respective cable within the respective lumen, wherein the electrically insulating jacket has an outside diameter of about <NUM> and a thickness of about <NUM> ; and
tape which is wrapped around the bundle of insulated wires underneath the shielding;
respective elongated members (<NUM>) disposed in second respective ones of the lumens, and connected to the distal end; and
a manipulator (<NUM>) connected to the elongated members and configured to actuate the distal end via the elongated members.