Catheter with reinforcing segment and attachment tube

Abstract

A catheter is disclosed comprising an elongated shaft having a distal portion and defining a lumen along its longitudinal axis. The elongated shaft includes a longitudinally extending inner member defining the lumen, a support member disposed on the longitudinally extending inner member, and a reinforcing member. The support member includes a proximal portion and a distal portion separated by a breakout section. The reinforcing member is disposed on the breakout section and has a reinforcing proximal end and a reinforcing distal end, the reinforcing proximal end being connected to the proximal portion and the reinforcing distal end being connected to the distal portion. The elongated tube extends along the shaft. The tube extends longitudinally along the proximal braid member radially below the proximal braid member, extends longitudinally on its outer surface along the distal braid member, and extends from below the proximal braid member to the outer surface of the breakout section.

Description

Technical Field

[0001] The present disclosure relates to medical devices for catheter insertion procedures, such as medical devices for electrophysiological procedures. More specifically, the present disclosure relates to catheters, catheter systems, and methods for manufacturing catheters.

Background Art

[0002] In various medical fields, various types of catheters are used to achieve access to physiological sites in medical procedures. For example, electrophysiological procedures involve guiding a catheter into the heart and tracking the position of the catheter within the heart. Catheter ablation is a minimally invasive electrophysiological procedure for treating various heart diseases such as supraventricular arrhythmias and ventricular arrhythmias. Exemplary catheters used in catheter ablation can include mapping catheters, ablation catheters, guide sheaths, dilators, and other medical instruments, which can be collectively referred to as catheters in the present disclosure. Electrophysiological procedures involve visualization of the heart, cardiac activity, and the position of the catheter within the heart. In general visualization systems, fluoroscopy is used, which can expose patients and clinicians to radiation. Electroanatomical mapping is an alternative visualization technique that does not involve the use of radiation.

[0003] Electroanatomical mapping enables clinicians to accurately locate arrhythmias, define the three-dimensional geometry of the heart, visualize anatomical regions of interest, and visualize the catheter for positioning and manipulation. Catheters used with electroanatomical mapping systems may include tracking functions such as navigation-enabled tracking or impedance-based tracking. Navigation-enabled catheters track the catheter's position and orientation using magnetic sensors in the presence of a magnetic field. However, not all catheters include magnetic sensors. Impedance-based catheters use electrodes in the presence of an electric field to track the catheter. [Overview of the project]

[0004] In Example 1, the catheter comprises an elongated shaft having a lumen defined along its longitudinal axis and a distal section, the shaft comprising a longitudinally extending inner member defining the lumen and a support member disposed on the longitudinally extending inner member, the support member comprising a proximal and distal portion separated by a breakout section, the distal portion comprising the support member having an outer surface and a reinforcing member disposed in the breakout section and having a reinforcing proximal end and a reinforcing distal end, the reinforcing proximal end being connected to the proximal portion and the reinforcing distal end being connected to the distal portion, the catheter comprising an electrode disposed in the distal portion of the elongated shaft, an elongated tube extending longitudinally along the elongated shaft, and a lead conductor disposed within the tube and electrically connected to the electrode, the tube extending longitudinally along the proximal portion radially below the proximal portion, extending longitudinally on its outer surface along the distal portion, and extending from below the proximal portion to the outer surface of the reinforcing member.

[0005] In Example 2, the support member in the catheter of Example 1 includes a braided stainless steel material. In Example 3, the braided material in the catheter of Example 2 includes conductive fibers. In Example 4, in any of the catheters in Examples 1 to 3, the elongated shaft further includes a reinforcing member having a tubular longitudinal side portion, a reinforcing proximal end, and a reinforcing distal end, the reinforcing proximal end being movably coupled to the proximal portion, and the reinforcing distal end being movably coupled to the distal portion.

[0006] In Example 5, the catheter in Example 4 includes one of the following: a frame-shaped member having a plurality of first annular members attached to a plurality of longitudinally extending intersecting members and spaced apart by the intersecting members; and a tubular coil-shaped member having a plurality of second annular members attached to a longitudinally extending coil and spaced apart by the coil.

[0007] In Example 6, in any of the catheters of Examples 4-5, the longitudinal side extends along the axis, the opening is formed on the longitudinal side, and the tube extends from below the proximal portion through the opening of the reinforcing member to the outer surface.

[0008] In Example 7, in any of the catheters from Examples 4 to 6, the reinforcing member is formed from a laser-cut tube. In Example 8, in any of the catheters from Examples 1-3, the reinforcing member includes threads wound around the tube and breakout section.

[0009] In Example 9, in any of the catheters of Examples 1 to 8, the shaft includes an outer layer disposed on the support member and the reinforcing member. In Example 10, the outer layer of the catheter in Example 9 contains a polyether block amide.

[0010] In Example 11, the electrode is a ring electrode in the catheter of Example 1. In Example 12, in any of the catheters in Examples 1 to 11, the electrodes include multiple electrodes and the tubes include multiple tubes.

[0011] In Example 13, in any of the catheters in Examples 1-12, the shaft includes a proximal end, which is operably connected to an electrical connector, and the lead conductor is electrically connected to an electrical conductor.

[0012] In Example 14, in any of the catheters in Examples 1 to 13, the proximal braided member includes an inner surface, and the tube extends longitudinally along the inner surface. In Example 15, in any of the catheters in Examples 1 to 14, the catheter is a guide catheter having a proximal end connected to a handle.

[0013] In Example 16, the catheter comprises an elongated shaft having a distal portion and defining a lumen along its longitudinal axis, the shaft comprising a longitudinally extending inner member defining the lumen, and a support member disposed on the longitudinally extending inner member, the support member comprising a proximal and distal portion separated by a breakout section, the distal portion comprising the support member having an outer surface, and a reinforcing member disposed on the breakout section and having a reinforcing proximal end and a reinforcing distal end, the reinforcing proximal end being coupled to the proximal portion and the reinforcing distal end being coupled to the distal portion, the catheter comprising an electrode disposed on the distal portion of the elongated shaft, an elongated tube extending longitudinally along the elongated shaft, and a lead conductor disposed within the tube and electrically connected to the electrode, the tube extending longitudinally along the proximal portion radially below the proximal portion, extending longitudinally on its outer surface along the distal portion, and extending from below the proximal portion to the outer surface of the reinforcing member.

[0014] In Example 17, the support member is formed from a braided material in the catheter of Example 16. In Example 18, the catheter of Example 16 includes conductive fibers in the proximal braided member and the distal braided member.

[0015] In Example 19, the catheter of Example 16 further includes a reinforcing member having a tubular longitudinal side portion, a reinforcing proximal end, and a reinforcing distal end, the reinforcing proximal end being movably coupled to the proximal portion, and the reinforcing distal end being movably coupled to the distal portion.

[0016] In Example 20, the reinforcing member in the catheter of Example 19 includes one of the following: a frame-shaped member having a plurality of first annular members attached to a plurality of longitudinally extending intersecting members and spaced apart by the intersecting members; and a tubular coil-shaped member having a plurality of second annular members attached to a longitudinally extending coil and spaced apart by the coil.

[0017] In Example 21, the reinforcing member in the catheter of Example 20 is formed from a laser-cut tube. In Example 22, in the catheter of Example 19, the longitudinal side extends along the axis, the opening is formed on the longitudinal side, and the tube extends from below the proximal portion through the opening of the reinforcing member to the outer surface.

[0018] In Example 23, in the catheter of Example 16, the reinforcing member includes threads wound around the tube and breakout section. In Example 24, the catheter of Example 16 includes an outer layer positioned on a support member and a reinforcing member.

[0019] In Example 25, the catheter of Example 16 includes multiple elongated tubes arranged radially apart on the outer side of the distal portion. In Example 26, in the catheter of Example 16, the inner member includes an inner surface, and the inner surface includes a liner layer.

[0020] In Example 27, the catheter in Example 16 includes one of a dilator and a guide catheter. In Example 28, the catheter of Example 16 includes a distal tip portion having an ablation electrode assembly.

[0021] In Example 29, the electrode is a ring electrode in the catheter of Example 16. In Example 30, the method for manufacturing a catheter includes the steps of forming a distal portion of an elongated member from an inner member defining a lumen, a proximal braided member, and a distal braided member spaced apart from the proximal braided member in a breakout section, wherein the proximal and distal braided members are positioned on the inner member to form a distal portion; attaching an elongated tube that extends longitudinally along the elongated member, extends inside the proximal braided member, extends longitudinally along the outside of the distal braided member, and passes through a breakout section; forming a reinforcing member on the breakout section; and positioning an outer layer on the elongated member to form a shaft.

[0022] In Example 31, the reinforcing member is formed by winding a thread around a long member in the method of Example 30. In Example 32, a system for tracking a catheter during an electrophysiological procedure on a patient includes a patch electrode that can be mechanically coupled to the patient and a catheter that can be disposed within the patient. The catheter includes a long, elongated shaft that defines a lumen along its longitudinal axis and has a distal portion. The shaft includes a proximal braided member that includes a distal end of a first braided member and a distal braided member that has an outer surface and a proximal end of a second braided member. The proximal end of the second braided member is longitudinally spaced from the distal end of the first braided member. The catheter also includes a reinforcing member that has an opening, a reinforced proximal end, and a reinforced distal end. The reinforced proximal end is operably coupled to the distal end of the first braided member, and the reinforced distal end is operably coupled to the proximal end of the second braided member. The catheter further includes an electrode disposed at the distal portion of the elongated shaft, an elongated tube that extends longitudinally along the elongated shaft, and a lead conductor disposed within the tube and electrically connected to the electrode. Here, the tube extends longitudinally along the proximal braided member radially below the proximal braided member, extends longitudinally on the outer surface along the distal braided member, and extends from within the lumen through the opening of the reinforcing member to the outer surface. The system also includes a controller operably connected to the patch electrode and the tracking electrode. The controller is configured to receive an electrical signal and determine the position of the catheter with respect to the patient.

[0023] In Example 33, in the system of Example 32, the controller is further configured to generate an electroanatomical map of the patient's heart. In Example 34, in the system of Example 32, the controller is configured to determine the position of the catheter via an impedance-based process.

[0024] In Example 35, in the system of Example 32, the reinforcing member is made of a material different from the proximal braided member and the distal braided member. Although multiple embodiments are disclosed, further other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description showing and explaining exemplary embodiments of the present invention. Therefore, the drawings and the detailed description should be regarded as being essentially exemplary and not restrictive.

Brief Description of the Drawings

[0025] [Figure 1] It is a diagram showing an exemplary clinical environment having an exemplary electrophysiological system for treating a patient and for treating the patient's heart. [Figure 2] It is a schematic diagram showing an exemplary catheter that can be used in the exemplary electrophysiological system of FIG. 1. [Figure 3A] It is a schematic diagram showing, in a side view, exemplary features of the exemplary catheter of FIG. 2. [Figure 3B] It is a schematic diagram showing, in a cross-sectional view, exemplary features of the exemplary catheter of FIG. 3A. [Figure 4A] It is a schematic diagram showing, in a side view, an exemplary reinforcing member of the exemplary catheter of FIG. 2. [Figure 4B] It is a schematic diagram showing, in a side view, another exemplary reinforcing member of the exemplary catheter of FIG. 2. [Figure 5] It is a schematic diagram showing, in a side view, another exemplary feature of the exemplary catheter of FIG. 2. [Figure 6] It is a block diagram showing an exemplary method of manufacturing a medical imaging device of FIG. 2.

Modes for Carrying Out the Invention

[0026] The present invention is capable of following various modified forms and alternative forms. However, specific embodiments are shown in the drawings as examples and will be described in detail below. However, the intention is not to limit the present invention to the specific embodiments described. Rather, the present invention is intended to include all modified forms, equivalents, and alternative forms within the scope of the present invention defined by the appended claims.

[0027] For the purpose of facilitating an understanding of the principles of this disclosure, examples shown in the drawings described below will be referenced. The exemplary examples disclosed herein are not intended to be exhaustive or to limit this disclosure to the exact forms disclosed for carrying out the inventions described below. Rather, these exemplary embodiments are selected and described so that those skilled in the art can use their teachings. It is not beyond the scope of this disclosure to use multiple (e.g., all) features across all examples. Accordingly, no drawing should be construed as having any dependencies or requirements relating to any single component or combination of components shown. In addition, various components shown in the drawings may, in some examples, be integrated with various other components shown (or not shown), all of which are within the scope of this disclosure.

[0028] Figure 1 illustrates an exemplary clinical environment 10 for treating a patient 20 (for example, for treating the patient 20's heart 30) using an electrophysiological system 50 according to this disclosure. The electrophysiological system 50 includes a catheter system 60 and an electroanatomical mapping (EAM) system 70. The exemplary catheter system 60 includes an elongated catheter assembly 100, which includes an ablation catheter 105 and a catheter sheath 110, and an electroporation console 130. In addition, the catheter system 60 includes various connecting elements (e.g., cables) that operably connect the components of the catheter system 60 to each other and to the components of the EAM system 70. Generally, the EAM system 70 includes a localization field generator 80, a mapping and navigation controller 90, and a display 92. The clinical environment 10 may also include additional equipment (e.g., imaging equipment 94 (represented by a C-arm)) and various controller elements (e.g., foot controller 96) configured to allow the operator to control various aspects of the electrophysiological system 50. The clinical environment 10 may have other components and configurations not shown in Figure 1.

[0029] The sheath 110 is operable to provide a delivery conduit through which the catheter 105 can be deployed to a specific target site within the patient's heart 30. Access to the patient's heart can be made through a blood vessel (e.g., a peripheral artery or vein). Once access to a blood vessel is obtained, the catheter 105 can be guided into the patient's heart (e.g., into a cardiac chamber).

[0030] An exemplary catheter system 60 is configured to deliver ablation energy to target tissue within the patient's heart 30 to induce cell death within the tissue, for example, by preventing the tissue from conducting electrical signals. A longitudinal catheter assembly (e.g., catheter assembly 100) may include multiple coaxially arranged catheters. For example, the catheters define a longitudinal axis passing through the centroid of the catheter's cross-section (e.g., the centroid of the cross-section of the shaft of catheter 105 or the centroid of the cross-section of the main lumen of the sheath 110). As shown in the figure, catheter 105 is located within the sheath 110. Catheters 105 and 110 are relative to each other along their longitudinal axes.

[0031] An exemplary catheter 105 includes a long catheter shaft and a distal end configured to deploy near a target tissue (e.g., within the cardiac chambers of a patient's heart). The distal end may include a basket, balloon, spline, configured tip, or other deployment mechanism for performing the treatment. The deployment mechanism may include an electrode assembly or array having multiple ablation electrodes. Each of the multiple ablation electrodes is electrically connected to a corresponding long lead conductor extending along the shaft to the proximal end of the catheter. The lead conductor may be electrically connected, for example, directly or via an intermediate electrical conductor such as cable wiring, to a plug in the proximal region of the catheter 105 (e.g., a plug configured to be mechanically and electrically connectable to a console 130). In one example, the console 130 is configured to perform ablation by supplying electrical signals (e.g., multiple simultaneous or time-spaced electrical signals) to the catheter 105, which is electrically connected along the lead conductors to spaced-out electrodes.

[0032] Console 130 is configured to control aspects of the catheter system 60. Console 130 includes a controller (e.g., one or more controllers, processors, or computers) which executes instructions (e.g., processor-executable instructions) or code from a non-temporary computer-readable medium (e.g., a memory device or memory) to control or execute aspects of the electroporation catheter system 60. Memory may be part of one or more controllers, processors, or computers, or part of a memory device accessible via a computer network. Examples of computer networks include local area networks, wide area networks, and the Internet.

[0033] The EAM system 70 may be capable of tracking the positions of various components of the catheter system 60 and generating high-fidelity three-dimensional anatomical and electroanatomical maps of the heart, including parts of the heart (e.g., chambers of interest or other structures of interest (e.g., the sinoatrial node or atrioventricular node)). In one exemplary example, the EAM system 70 may include the RHYTHMIA® HDx mapping system, marketed by Boston Scientific Corporation. The mapping and navigation controller 90 of the EAM system 70 includes one or more controllers, such as a microprocessor or computer, that execute code from memory to control or perform functional aspects of the EAM system 70, and the memory may be part of one or more controllers, microprocessors, computers, or part of a memory device accessible through a computer network.

[0034] The EAM system 70 can generate a localization field via a magnetic field generator 80 to form a localization volume around the heart 30, and a position sensor or sensing element on the device being tracked (e.g., a sensor on the electroporation catheter 105) generates an output that can be processed by the mapping and navigation controller 90 to track the position and orientation of one or more sensors, and thus the corresponding device, within the localization volume. In the illustrated example, device tracking is performed using a magnetic tracking technique, the magnetic field generator 80 is a magnetic field generator that generates a magnetic field that forms the localization volume, and the position sensor on the device being tracked is a magnetic field sensor.

[0035] In other examples, impedance tracking methods can be used to track the location of various devices. In such examples, the localization field is a group of independently oriented and spatially varying electric fields generated, for example, by an external field generator configuration (e.g., surface electrodes), by an internal device or an intracardiac device (e.g., an intracardiac catheter), or both. In these examples, the localization element can consist of tracking electrodes on the tracked catheter that generate outputs received and processed by a mapping and navigation controller 90 to track the location of various localization electrodes within a localization volume. For example, the impedance tracking method may employ the use of patch electrodes (not shown) attached to the patient's body, and a value based on the current or impedance between the tracking electrode on the catheter and the patch electrode can be determined.

[0036] The EAM system 70 may have magnetic tracking capabilities, impedance tracking capabilities, or both. Regardless of the tracking method used, the EAM system 70 utilizes positional information from various tracking devices and cardiac electrical activity acquired, for example, by an electroporation catheter 105 equipped with sensing electrodes or another catheter or probe, to generate a detailed three-dimensional geometric anatomical map or representation of cardiac tissue and spaces (e.g., cardiac chambers), as well as an electroanatomical map in which the cardiac electrical activity of interest is superimposed on the geometric anatomical map, and displays these on the display 92. Furthermore, the EAM system 70 can generate graphic representations of various tracking devices within the geometric anatomical map or electroanatomical map.

[0037] In impedance-based tracking using the EAM system 70, the catheter includes tracking electrodes positioned on a deflectable portion of the catheter shaft. Multiple tracking electrodes may be provided on the deflectable portion of the catheter so that the EAM system 70 can detect and reproduce the curvature of the catheter within the body. In one example, each tracking electrode is connected to a corresponding lead conductor or lead wire, which extends along the shaft to the proximal portion and is connected to an electrical connector at the proximal portion. The electrical connector may be connected to the EAM system 70 via a cable or the like.

[0038] Several constraints are applied to the design and implementation of tracking electrodes and their associated lead conductors. These constraints include the requirement that each tracking electrode and associated lead conductor be electrically insulated from each other and from other conductive materials within the catheter, such as conductive braided members along the length of the shaft. Furthermore, it is desirable to precisely position the tracking electrodes on the shaft. For example, tracking electrodes may be radiopaque, allowing clinicians to visualize the catheter's position when using fluoroscopy. Also, the electrode position relative to the catheter elements and the inter-electrode spacing are programmed parameters in some tracking and mapping software programs, and 3D reconstruction and modeling are performed using the electrode spacing as a constraint in the modeling curve. Therefore, the design and implementation of catheters using tracking electrodes are advantageous due to easier access to the lumen housing the conductor leads.

[0039] This disclosure relates to a catheter having a segment in a braided member that allows a tube housing a lead wire conductor to transition from a main lumen to the outer surface of the braided member. The segment can provide shaft rigidity, pushability, kink resistance, flexibility, and torque transmission, which may be undesirably affected if a large portion of the braided member is removed to allow the tube to pass through. The catheter includes an elongated shaft that defines a lumen along its longitudinal axis and has a distal segment. The elongated shaft includes a longitudinally extending inner member that defines the lumen, a support member positioned on the longitudinally extending inner lumen, and a reinforcing member. The support member includes a proximal and distal portion separated by a breakout section, the distal portion including an outer surface. The reinforcing member is positioned on the breakout section and includes a reinforcing proximal end and a reinforcing distal end. The reinforcing proximal end is coupled to the proximal portion, and the reinforcing distal end is coupled to the distal portion. An electrode is positioned on the distal portion of the elongated shaft. The elongated tube extends longitudinally along the elongated shaft. The lead conductor is placed inside the tube and electrically connected to the electrode. The tube extends longitudinally along the proximal portion radially downward from the proximal portion, longitudinally on its outer surface along the distal portion, and extends from below the proximal portion to the outer surface of the reinforcing member.

[0040] Figure 2 shows an exemplary catheter 200 that can be used in the catheter assembly 100. For example, the catheter 200 may be further configured as a guide catheter, dilator, ablation catheter, or other flexible deflectable medical device that can be tracked via an impedance tracking system such as the EAM system 70. The catheter 200 includes an elongated shaft 202, such as an elongated flexible shaft 202 defining a longitudinal axis A. The shaft 202 also defines a main lumen 204 along the longitudinal axis A and has a proximal section 206, a longitudinal section 208, and a distal section 210. The distal section 210 includes a distal tip portion 212. The proximal section 206 may be connected to a handle 214 located proximal to the shaft 202.

[0041] The shaft 202 is arranged along the distal section 210 and includes a plurality of components that define the main lumen 204. The shaft 202 includes a support member 224 positioned between a longitudinally extending inner member 226 and a longitudinally extending outer layer 290. The inner member 226 defines the main lumen 204, and the support member 224 is positioned on the inner member 226. In various examples, the inner layer, the outer layer, or both are formed from a plurality of layers. The support member 224 includes a longitudinal flexible proximal portion of the support member positioned on the inner member 226, i.e., a proximal support member 230, and the support member 224 includes a distal portion of the support member positioned on the inner member 226, i.e., a distal support member 240. The distal support member 240 includes an outer surface 242. The distal support member 240 is positioned longitudinally from the proximal support member 230 along axis A in the breakout section of the support member 224. The distal support member 240 is positioned longitudinally from the proximal support member 230 at an appropriate distance. In various embodiments, the distance of the gap can range from 1 mm to 20 mm, for example, the breakout section is in the range of 2 mm to 10 mm. In the illustrated example, the proximal support member 230 and the distal support member 240 include a braided fabric, such as a stainless steel braided fabric. For illustrative purposes, the support member 224 and the proximal support member 230 and the distal support member 240 are presented as braided member 224 and proximal braided member 230 and distal braided member 240. In some examples, the proximal support member 230 and the distal support member 240 are made of different materials. For example, the proximal support member 230 may be a braided fabric, and the distal support member 240 may be a coiled shaft member or a tubular structure such as a hypo tube. Furthermore, in some examples, neither the proximal support member 230 nor the distal support member 240 is a braided fabric.

[0042] According to various embodiments, the reinforcing member 250 is positioned between the proximal support member 230 and the distal support member 240, for example, along axis A in the breakout section of the support member 224. The reinforcing member 250 is coupled to the proximal support member 230 and the distal support member 240. In some examples, the reinforcing member 250 is made of a different material from the proximal support member 230 and the distal support member 240. The reinforcing member 250 may include a plastic or metal tubular member without a braided fabric, a tension relief section, yarn wound around the inner member 226, or yarn wound around the support member 224 and the inner member 226, a braid or braided section, or other structures. In some examples, the reinforcing member 250 includes openings 260, such as a plurality of apertures or openings along the longitudinal side of the reinforcing member 250. For example, a reinforcing member 250 constructed from threads wound around the support member 224 and the inner member 226 may include openings between the coil pitches.

[0043] The elongated tube 270 extends longitudinally along the shaft 202 and houses a lead conductor 272 connected to an electrode 280 (e.g., a tracking electrode) positioned on the distal portion 208 of the shaft 202. The tube 270 extends longitudinally along the shaft 202, radially underneath the proximal braid member 230, passing through the proximal braid member 230. In various examples, the proximal braid member 230 includes an inner surface 232. The tube 270 extends longitudinally along the proximal braid member 230 radially below the inner surface 232, such as between the inner surface 232 and the inner member 226. In the breakout section of the braid member 224, the tube 270 extends from below the proximal braid member 230 to the outer surface 242 of the distal braid member 240. To pass from below the proximal braid member 230 to the outer surface 242 of the distal braid member 240, the tube 270 extends longitudinally along the outer surface 242 of the distal braid member 240 by passing below the end of the reinforcing member 250 (e.g., below the distal end of the reinforcing member 250), above the end of the reinforcing member 250 (e.g., above the proximal end of the reinforcing member), or through the opening 260 of the reinforcing member 250. The tube 270 can be attached to the outer surface 242 of the distal braid member 240.

[0044] In various examples, the distal portion 210 of the shaft 202 includes a plurality of longitudinally spaced tracking electrodes 280a, 280n, each tracking electrode 280a, 280n may be electrically connected to a corresponding individual lead conductor housed in a tube that extends longitudinally along the shaft 202 and terminates at the proximal portion 206. The tracking electrodes 280 are illustrated as ring electrodes on the shaft. In some examples, the tracking electrodes 280a-280n are configured for use in an impedance-based tracking system. The proximal portion 206 or handle 212 may include an electrical connection that can be connected to an impedance-based tracking system such as an EAM system 70. In one example, the electrical connection is available under the trade name LEMO. In some examples, the shaft 202 further includes an outer layer 290 positioned on top of the braided member 224 and tube 270 to form the outermost surface 292 of the shaft 202. The tracking electrodes 280a and 280n are exposed on the outermost surface 292 of the catheter 200.

[0045] The catheter 200 may include additional components for selected embodiments. In some examples, if the catheter 200 is configured as a guide sheath or dilator, the proximal portion 206 or handle 214 may include a hemostatic valve connectable to a perfusion fluid supply source and a port for receiving the catheter into the main lumen 204. In some examples, the distal tip portion 212 may be configured as the tip of the dilator. In some examples, the shaft 202 is coaxial with the main lumen 204 and includes a liner layer (not shown) that forms the inner wall of the main lumen 204. In examples such as when the catheter 200 is a guide sheath or dilator, the liner layer may be a thin wall made of polytetrafluoroethylene (PTFE). In some examples, such as when the catheter 200 is configured as an ablation catheter, the proximal portion 206 or handle may be connected to an ablation energy supply source such as an electrical signal from the console 130 or a cryogenic fluid. For example, the main lumen 204 may be configured to accommodate electrical leads such as leads to ablation electrodes or other sensors, steering wires, or conduits for irrigation fluid to the distal portion 210 along the shaft 202. In some examples, the distal tip portion 212 may be configured to include an ablation electrode assembly or other sensors.

[0046] Figures 3A and 3B show an example of a catheter 200 having a reinforcing member as a tubular structure positioned in the breakout section of the support members between spaced-apart proximal and distal support members. Figure 3A is a perspective view illustrating the features of the catheter 200, and Figure 3B includes a cross-sectional front view of the catheter 200, such as the distal portion 210, taken along line 3-3 in Figure 3A. As shown, the support members are made of a braided fabric. In particular, the catheter 200 includes a long, flexible shaft 202. The shaft 202 includes a braided member 224, a longitudinally extending inner member 226, and an outer layer 290, which are coaxial with the main lumen 204. The longitudinal inner member 226 defines the main lumen 204. The braided member 224 may include an inner 306 positioned toward the main lumen 204 and opposite to the outer 222. A longitudinally extending inner member 226 (e.g., multiple longitudinally extending inner layers) is positioned radially below the braided member 224. The inner member 226 may include an outer surface 304 (radially below the inner surface 302 of the braided member 224) and an inner wall 306 defining the main lumen 204. In some examples, the shaft 202 may include multiple concentric or coaxial braided members along a longitudinal section of the shaft 202, such as an innermost braided member and an outermost braided member. In certain examples, a single distal braided member 240 positioned along a longitudinal section of the shaft 202 (i.e., a distal braided member 240 that is not concentric with other distal braided members) is also an outermost distal braided member, such as the outermost distal braided member 240 shown.

[0047] The braided member 224 of the shaft 202 includes an elongated proximal portion or proximal braided member 230 positioned on the inner member 226, and the braided member 224 includes a distal portion or distal braided member 240 positioned on the inner member 226. The distal braided member 240 includes an outer surface 242. The distal braided member 240 is positioned longitudinally from the proximal braided member 230 along axis A in the breakout section of the braided member 224. In some examples, the distance between the proximal braided member 230 and the distal braided member 240 is in the range of 2 mm to 10 mm (e.g., 5 mm). A reinforcing member 250 is positioned between the proximal braided member 230 and the distal braided member 240, for example in the breakout section along axis A. The proximal braided member 230 distally terminates at the distal end 320 of the first braided member. The distal braided member 240 terminates proximal at the proximal end 322 of the second braided member. The distal end 320 of the first braided member is positioned longitudinally spaced from the proximal end 322 of the second braided member. The reinforcing member 250, in various examples, includes a longitudinal surface 330 having an opening 260, and terminates proximal at the reinforcing proximal end 324 and distal at the reinforcing distal end 326. The reinforcing member 250 is coupled to the proximal braided member 230 and the distal braided member 240. For example, the reinforcing proximal end 324 is coupled to the distal end 320 of the first braided member, and the reinforcing distal end 326 is coupled to the proximal end 322 of the second braided member.

[0048] In some examples, the reinforcing member 250 includes an outer surface 330 such as a longitudinal surface 330, and the distal end 320 of the first braided member is positioned below the outer surface 330 of the reinforcing member 250 such that the reinforcing member 250 and the proximal reinforcing end 324 overlap with the distal section of the proximal braided member 230. In various other examples, the proximal end 322 of the second braided member is positioned below the outer surface 330 of the reinforcing member 250 such that the reinforcing member 250 and the distal reinforcing end 326 overlap with the proximal section of the distal braided member 240. In other examples, the reinforcing member may be positioned to overlap with the proximal section, or the proximal and distal reinforcing ends may abut against the first and second braided ends. In some examples, the reinforcing member 250 is attached to the proximal braided member 230 and the distal braided member 240 by, for example, crimping the reinforcing member 250 near the reinforcing ends 324, 326. Tubular mounting components 332 and 334, such as tubular parts of polyethylene terephthalate (PET) medical heat shrink tubing, can be attached to the reinforcing member 250 and the proximal braid member 230 and the distal braid member 240 at their respective overlapping sections for support. Other examples are conceivable, such as the reinforcing member 250 and the proximal braid member 230 and the distal braid member 240 being welded or bonded together, or the braided ends being laser-cut and welded to reduce the possibility of the braided fibers unraveling.

[0049] In an example where the reinforcing member 250 includes an opening 260 through which the tube 270 extends, the opening 260 is positioned on the reinforcing member 250 so as to be located between the spaced distal end 320 of the first braided member of the proximal braided member 230 and the proximal end 322 of the second braided member of the distal braided member 240. The opening 260 may also be located between spaced tubular mounting parts 332, 334.

[0050] The proximal braided member 230 and the distal braided member 240 can impart properties to the catheter 200 such as reduced twisting, wrinkling, or buckling of the shaft 202, and can improve the balance of pushability, deflection, and torque transmission during rotation around the longitudinal axis A. The braided members 230 and 240 may consist of layers 342 of woven fabric or braided strands or braided fibers, such as a woven fabric 340 that can form gap spaces 344 between the fibers 342. The braided members 230 and 240 can be further characterized by the warp and weft threads, bias, and pick count per inch of the fibers 342. For example, in some examples, the pick count per inch can be maintained substantially uniformly along the entire longitudinal length of one or both of the braided members 230 and 240. In some examples, the pick count per inch can vary along portions of the longitudinal length of one or both of the braided members 230 and 240. The braided members 230 and 240 may be composed of fibers 342 including stainless steel fibers such as conductive fibers, or high-strength polymer fibers, or may be composed of layers of different materials. The braided members 230 and 240 may be composed of the same or different types of woven fabrics 340.

[0051] The reinforcing member 250 is, in various examples, a tubular member such as a plastic or metal tube suitable for bonding to the braided members 230, 240 and for attachment to the PET heat-shrinkable parts 332, 334. In one example, the reinforcing member 250 is composed of plastic extruded or laser-cut metal tubing and can be molded as a frame-like member or a tubular coil-like member. In some examples, the reinforcing member 250 is configured to conform to the lamination or reflow process used to apply the outer layer 290 of the catheter 200. In one example, the reinforcing member 250 may include multiple holes or have an open structure in addition to the opening 260, through which the plastic of the outer layer 290 can flow during the lamination process to provide additional strength. The size (e.g., outer diameter) of the reinforcing member 250 may be selected so as not to significantly increase the outer diameter of the shaft 202, and the length of the reinforcing member 250 may be selected so as to allow sufficient structural support between the proximal braided member 230 and the distal braided member 240, which are spaced apart in the longitudinal direction, without significantly affecting the desired properties of the shaft 202.

[0052] The elongated tube 270 extends longitudinally below the proximal braided member 230. In one example, the elongated tube 270 makes interface contact with the inner surface 232 of the proximal braided member 230 as the tube 270 passes through the proximal braided member 230. The elongated tube 270 also makes interface contact with the outer surface 242 of the distal braided member 240. For example, the elongated tube 270 may be in contact with the outer surface 242 of the distal braided member 240, or bonded to the outer surface 242 of the distal braided member 240 (e.g., using an adhesive), or otherwise attached to the outer surface 242 of the distal braided member 240. For example, a longitudinally extending coiled yarn, such as nylon yarn or twisted yarn, can be wound around the braided member 224, the reinforcing member 250, and the tube 270 to hold the tube 270 at least relative to the distal braided member 240. In one example, if the reinforcing member 250 overlaps with the proximal braiding member 230 and the distal braiding member 240, the tube 270 can extend from within the reinforcing member at the distal end 326 of the reinforcing member 250 to the outer surface 242 of the distal braiding member 240. In another example, the tube 270 can move from below the proximal braiding member 230 through the opening 260 to the outer surface 242 of the distal braiding member 240. In one example, the elongated tube 270 extends substantially straight longitudinally along the proximal braiding member 230 and the distal braiding member 240. The elongated tube 270 is made of a suitable material such as a polymer and defines a lead lumen 360 that extends longitudinally along the length of the tube 270. The tube 270 is configured to house a lead conductor, such as a lead wire 272, within the lead lumen 360. The lead wire 272 is electrically connected to the tracking electrode 280 and is configured to transmit the appropriate electrical signal from the electrical connector of the proximal portion 204 to the tracking electrode 280. In one example, the elongated tube 270 has a substantially smaller diameter than the shaft 202, and the main lumen 204 has a substantially larger diameter than the lead lumen 360.

[0053] In one example of a catheter 200 including multiple tracking electrodes, elongated tubes for housing lead wires are included for each tracking electrode. Each of the tubes extends longitudinally along the proximal braid member 230 radially below the proximal casing member 230, longitudinally on the outer surface 242 along the distal braid member 240, and extends to the outer surface 242 in the reinforcing member 250. In one example, the reinforcing member 250 may include openings for each elongated tube 270. In some examples, the catheter 200 may include two tracking electrodes, and include a first elongated tube 270a housing a first lead wire 272a in a first lead lumen 360a, and a second elongated tube 270b housing a second lead wire 272b in a second lead lumen 360b. Multiple elongated tubes 270 may be arranged radially below the proximal braiding member 230 and on the outer side 242 of the distal braiding member 240, spaced radially apart. The reinforcing member 250 may include multiple openings spaced radially apart. For example, the elongated tubes 270a, 270b and the openings are spaced 180 degrees apart radially. The lead wires 272 may be placed inside the elongated tubes 270 as bare wires or as wires with an insulating coating. Each elongated tube 270 may be terminated close to the corresponding tracking electrode.

[0054] The outer layer 290 may be positioned on the proximal braid member 230, the reinforcing member 250, and the distal braid member 240, and may also be positioned on the tube 270 so as to be positioned on the outer surface 242 of the distal braid member 240. In some examples, the outer layer 290 may be formed as a coating of a reflowable plastic or thermoplastic material that extends over the braid member 224 and seals the lower components of the shaft 202. For example, the coating may penetrate over the braid material of the proximal braid member 230 and the distal braid member 240 (e.g., over the fibers 342), and over the tube 270 and the reinforcing member 250 by reflowing into the gap spaces 344 of the braid material 340. A thicker wall of the outer layer 290 over the breakout section, or between the proximal braid member 230 and the distal braid member 240, helps to improve the strength of the shaft 202 and suppress the generation of stress lines. In one example, the outer layer 290 is a polyether block amide, which in some cases is available under the trade names PEBAX from Arkema, SA and VESTAMID E from Evonik Industries, AG.

[0055] Figure 4A shows an exemplary frame-shaped reinforcing member 400 as an example of a reinforcing member 250. The frame-shaped reinforcing member 400 includes a proximal annular member 402, a distal annular member 404, and a plurality of intersecting members 406, the plurality of intersecting members 406 extending between the annular members 402 and 404 and forming a plurality of openings 408 between the plurality of intersecting members 406. The annular members 402 and 404 are arranged on axis A and are configured to surround the braided members 230 and 240. The intersecting members 406 are arranged longitudinally along axis A, spaced apart from the annular members 402 and 404. The proximal annular member 402 includes a reinforcing proximal end 410 and is suitable for coupling to the proximal braided member 230. The distal annular member 404 includes a reinforcing distal end 412 suitable for coupling to the distal braided member 240. For example, the distal end 320 of the first braided member can be fitted under the proximal annular member 402, and the proximal braided member 230 can be attached to the frame-like reinforcing member 400 using PET heat shrink acrylic. The proximal end 322 of the second braided member can be fitted under the distal annular member 404, and the distal braided member 240 can be attached to the frame-like reinforcing member 400 using PET heat shrink acrylic. Another example may include a proximal braided member and a distal braided member located above the end of the tubular reinforcing member 400. With the proximal braided member 230 and the distal braided member 240 located below the annular members 402, 404, the tube 270 can extend from the reinforcing member 400, from below the distal annular member 404, and onto the outer surface of the distal braided member 240. The annular members 402 and 404 can be crimped onto the braided members 230 and 240, or onto the braided members 230 and 240 and the tube 270. One of the multiple openings 408 between the intersecting members 406 can be used as an opening 260 for extending the tube 270 through the reinforcing member 400. Multiple tubes can extend through one of the openings 408 between the intersecting members 406, or each tube of the multiple tubes can correspond to one of the multiple openings 408. The spacing of the intersecting members 406 can be selected so that the tube 270 can be fitted to pass through the openings 408 without additional processing or drilling to form larger gaps.The frame-like reinforcing members may be made of plastic or metal such as stainless steel, so as to be distinguishable from the braided material, and may be either rigid or flexible. The number of intersecting members 406 may be selected based on the desired rigidity, flexibility, opening size, or other properties. In several examples, the frame-like reinforcing members 400 may be formed from laser-cut metal tubes or extruded plastic tubes.

[0056] Figure 4B shows an exemplary tubular double-coil reinforcing member 450 as an example of a reinforcing member 250. The double-coil reinforcing member 450 includes a proximal annular member 452, a distal annular member 454, and a plurality of coil members such as coil members 456a, 456b, the coil members 456a, 456b extending between the annular members 452, 454 and forming a plurality of openings 458 between the coil members 456a, 456b. The annular members 452, 454 are arranged on axis A and are configured to surround the braided members 230, 240. The coil member 456 is coiled around axis A at a selected pitch so as to arrange the annular members 452, 454 longitudinally along axis A. The proximal annular member 452 includes a reinforcing proximal end 460 and is suitable for coupling to the proximal braided member 230. The distal annular member 454 includes a reinforcing distal end 462 suitable for coupling to the distal braided member 240. For example, the distal end 320 of the first braided member can be fitted under the proximal annular member 452, and the proximal braided member 230 can be attached to the coiled reinforcing member 400 using PET heat shrink. The proximal end 322 of the second braided member can be fitted under the distal annular member 454, and the distal braided member 240 can be attached to the coiled reinforcing member 450 by PET heat shrink. Another example may include a proximal and distal braided member above the end of the tubular reinforcing member 450. With the proximal braided member 230 and distal braided member 240 below the annular members 452, 454, the tube 270 can extend from the reinforcing member 450, from under the distal annular member 454, and onto the outer surface of the distal braided member 240. The annular members 452 and 454 can be crimped onto the braided members 230 and 240, or onto the braided members 230 and 240 and the tube 270. Multiple openings 458 between the coil members 456 can be used as openings 260 for extending the tube 270 through the reinforcing member 450. Multiple tubes can extend through the openings 458 between the intersecting members 456 such that they are spaced radially or longitudinally over the openings 408. The spacing of the coil members 456 can be selected so that the tube 270 can be adapted to pass through the openings 458 without requiring additional processing or drilling to form larger gaps.The frame-like reinforcing members may be made of plastic or metal such as stainless steel, so as to be distinguishable from the braided material, and may be either rigid or flexible. The width, spacing, pitch, and number of the intersecting members 406 may be selected based on the desired rigidity, flexibility, opening size, or other properties. In several examples, the coil-like reinforcing members 450 may be formed from laser-cut metal tubes or extruded plastic tubes.

[0057] Figure 5 shows an exemplary distal section of a catheter 500 having a coiled or wound thread as a reinforcing member 550 positioned between spaced-apart proximal and distal support members. The support members are shown as braided members formed from braided material. The shaft 502 includes a braided member 524 and an outer layer 590, which are radially positioned on a longitudinally extending inner member 526, and are coaxial with the main lumen 504. The longitudinally extending inner member 526 defines the main lumen 504. The braided member 524 may include an inner side positioned toward the main lumen 504 and opposite to the outer side 522. The longitudinally extending inner member 526 is positioned radially below the braided member 524. The inner member 526 may include an outer surface 528 (radially below the inner surface of the braided member 524) and an inner wall defining the main lumen 504.

[0058] The braided member 524 includes an elongated proximal braided member 530 positioned on the inner member 526, and the braided member 524 includes a distal braided member 540 positioned on the inner member 526. The distal braided member 540 includes an outer surface 542. The distal braided member 540 is positioned longitudinally away from the proximal braided member 530 along axis A in the breakout section 527 of the braided member 524. The proximal braided member 530 distally terminates at the distal end 620 of the first braided member. The distal braided member 540 proximal terminates at the proximal end 622 of the second braided member. The distal end 620 of the first braided member is positioned longitudinally away from the proximal end 622 of the second braided member. The distance between the proximal braided member 530 and the distal braided member 540, such as the distance between the distal end 620 of the first braided member and the proximal end 622 of the second braided member, can be an appropriate distance such as 2 millimeters to 10 millimeters. Tubular mounting parts 632 and 634, such as tubular parts of PET heat shrink tubing, can be attached to the proximal braided member 530 and the distal braided member 540 on the distal end 620 of the first braided member and the proximal end 622 of the second braided member, to further fix the braided member 524 to the inner member 526.

[0059] The tube 570 extends radially below the proximal braid member 530 and the tubular attachment 632, such as between the inside of the proximal braid member 530 and the outside 528 of the inner member 526 in the breakout section 527, to radially above the outside 542 of the distal braid member 540 (it may also extend above the tubular attachment 634 as shown). The reinforcing member 550 is composed of yarn such as filaments, twists, or braids, wound or coiled around the proximal braid member 530 and the distal braid member 540, the inner member 526, and the tube 570, as shown, with the yarn wound at a selected pitch and tension. For example, the reinforcing member 550 may include nylon 12 yarn having sufficient strength and melting temperature to withstand further manufacturing processes. The reinforcing member 570 may be wound over the proximal braiding member 530, over the tube 570 extending from the distal end 620 of the proximal braiding member 530, over the tube 570 and the inner member 526, and over the tube 570 and the outer 522 of the distal braiding member 540. The yarn may terminate at the outer 522 of both the proximal and distal braiding members, and the tube 570 may extend further distally beyond the yarn. In one example, the pitch or tension of the yarn may differ over the proximal braiding member 530 and the distal braiding member 540 compared to over the breakout section 527. For example, the pitch may be increased over the breakout section 527 than over the proximal braiding member 530 and the distal braiding member 540. In one example, multiple yarns may be used to form the reinforcing member 550, or the structure may be placed in the breakout section 527. For example, a metal slat extends across the breakout section 527 and is covered with thread to form a reinforcing member 550. In one example, the proximal support member 530 and the distal support member 540 are close enough to each other but spaced far enough apart to allow the tube 570 to extend through the breakout section 527 without thread being wound around the braided member or the breakout section.

[0060] Features of a catheter similar to those of catheter 200 can be configured similarly. For example, the braided member 524 may be configured as described above. The elongated tube 570 is made of a suitable material such as a polymer and defines a lead lumen that extends longitudinally along the length of the tube 570. The tube 570 is configured to house a lead conductor, such as a lead wire, within the lead lumen. The lead wire is electrically coupled to a tracking electrode and is configured to transmit an appropriate electrical signal from an electrical connector at the proximal portion of the catheter to the tracking electrode.

[0061] Figure 6 shows an exemplary method 600 for manufacturing a catheter. In one example, method 600 includes a method for defining a lumen and constructing a catheter shaft attached to a tube, the tube defining a lead lumen including a conductive lead configured to be attached to a tracking electrode exposed on the catheter shaft. In one example, in 602, an elongated braided member is formed on an inner member, the braided member having a proximal braided member longitudinally spaced from the distal braided member by a breakout section. In one example, the elongated braided member, such as braided member 224, is formed by connecting the proximal and distal braided members to a reinforcing member having an opening. The proximal and distal braided members may include a braided material of conductive stainless steel. The reinforcing member is, in one example, a tubular member that does not contain a braided material. In 604, a longitudinally extending elongated tube is attached along an elongated braided member, the tube running longitudinally along the proximal braided member and radially below the proximal braided member to a breakout section, and then extending along the outer surface of the distal braided member. In the example of a reinforcing member, the tube is running longitudinally along the proximal braided member and radially below the proximal braided member, extending through an opening on the longitudinal surface of the reinforcing member, and then extending along the outer surface of the distal braided member. In another example of a reinforcing member, the tube is running longitudinally along the proximal braided member and radially below the proximal braided member, extending through a breakout section, and then extending along the outer surface of the distal braided member. Yarn is wound around the braided member, the inner member, and the tube in the breakout section. In 606, a cover (or outer layer) is attached to the tube and the braided member. In one example, a thread, such as nylon yarn, can be wound longitudinally around the tube and the braided member to hold the tube against the distal braided member. The distal end of the tube is sealed to protect the lead lumen while the outer layer is applied. The distal end of the tube is sealed to reduce the possibility of the outer layer filling the lead lumen. In addition, as preparation for the outer layer, the distal end of the tube may be reinforced to be held under tension against the distal braided member.In one example, the distal end of the tube is secured to the outer surface of the distal braided member by a mounting member, which includes a tape such as silicone tape, a molten extruded material, or heat-shrinkable tubing that is placed over the end and heated. An example of heat-shrinkable tubing is PET medical heat-shrinkable tubing. The cover (or outer layer) may be applied via reflow. The mounting member is removed after the outer layer has been applied. In 608, the lead conductor is inserted into the lead lumen of the tube, and the lead conductor is electrically connected to a tracking electrode positioned on the shaft.

[0062] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of this disclosure. For example, while the embodiments described above refer to specific features, the scope of the invention also includes embodiments having different combinations of features, and embodiments that do not include all of the described features. Accordingly, the scope of the invention is intended to encompass all such alternative forms, modifications, and variations included in the claims, along with all their equivalents.

Claims

1. It is a catheter, A long shaft having a lumen defined along its longitudinal axis and a distal section, An inner member extending in the longitudinal direction that defines the lumen, A support member disposed on the longitudinally extending inner member, the support member including a proximal portion and a distal portion separated by a breakout section, the distal portion having an outer surface, The elongated shaft includes a reinforcing member positioned in the breakout section and having a reinforcing proximal end and a reinforcing distal end, wherein the reinforcing proximal end is coupled to the proximal portion and the reinforcing distal end is coupled to the distal portion; An electrode positioned at the distal portion of the elongated shaft, A long tube extending longitudinally along the long shaft, The tube comprises a lead conductor disposed within the tube and electrically connected to the electrode, A catheter wherein the tube extends longitudinally along the proximal portion radially below the proximal portion, extends longitudinally on the outer surface along the distal portion, and extends from below the proximal portion to the outer surface of the reinforcing member.

2. The catheter according to claim 1, wherein the support member includes a braided stainless steel material.

3. The catheter according to claim 2, wherein the braided material includes conductive fibers.

4. The catheter according to any one of claims 1 to 3, wherein the elongated shaft further includes a reinforcing member having a tubular longitudinal side portion, a reinforcing proximal end, and a reinforcing distal end, the reinforcing proximal end being operably coupled to the proximal portion, and the reinforcing distal end being operably coupled to the distal portion.

5. The catheter according to claim 4, wherein the reinforcing member includes one of the following: a frame-shaped member having a plurality of first annular members attached to a plurality of longitudinally extending intersecting members and spaced apart by the intersecting members; and a tubular coil-shaped member having a plurality of second annular members attached to a longitudinally extending coil and spaced apart by the coil.

6. The catheter according to claim 4 or 5, wherein the longitudinal side portion extends along the axis, an opening is formed on the longitudinal side portion, and the tube extends from below the proximal portion through the opening of the reinforcing member to the outer surface.

7. The catheter according to any one of claims 4 to 6, wherein the reinforcing member is formed from a laser-processed tube.

8. The catheter according to any one of claims 1 to 3, wherein the reinforcing member includes a thread wound around the tube and the breakout section.

9. The catheter according to any one of claims 1 to 8, wherein the shaft includes an outer layer disposed on the support member and the reinforcing member.

10. The catheter according to claim 9, wherein the outer layer comprises a polyether block amide.

11. The catheter according to claim 1, wherein the electrode is a ring electrode.

12. The catheter according to any one of claims 1 to 11, wherein the electrode includes a plurality of electrodes, and the tube includes a plurality of tubes.

13. The catheter according to any one of claims 1 to 12, wherein the shaft includes a proximal end, the proximal end is operably connected to an electrical connector, and the lead conductor is electrically connected to an electrical conductor.

14. The catheter according to any one of claims 1 to 13, wherein the proximal braided member includes an inner surface, and the tube extends longitudinally along the inner surface.

15. The catheter according to any one of claims 1 to 14, wherein the catheter is a guide catheter having a proximal end connected to a handle.

16. It is a catheter, A long shaft having a lumen defined along its longitudinal axis and a distal portion, An inner member extending in the longitudinal direction that defines the lumen, A support member disposed on the longitudinally extending inner member, the support member including a proximal portion and a distal portion separated by a breakout section, the distal portion having an outer surface, The elongated shaft includes a reinforcing member positioned in the breakout section and having a reinforcing proximal end and a reinforcing distal end, wherein the reinforcing proximal end is coupled to the proximal portion and the reinforcing distal end is coupled to the distal portion; An electrode positioned at the distal portion of the elongated shaft, A long tube extending longitudinally along the long shaft, The tube comprises a lead conductor disposed within the tube and electrically connected to the electrode, A catheter comprising a tube that extends longitudinally along the proximal portion radially below the proximal portion, extends longitudinally on the outer surface along the distal portion, and extends from below the proximal portion to the outer surface of the reinforcing member.

17. The catheter according to claim 16, wherein the support member is formed from a braided material.

18. The catheter according to claim 16, wherein the proximal braided member and the distal braided member include conductive fibers.

19. The catheter according to claim 16, wherein the elongated shaft further includes a reinforcing member having a tubular longitudinal side portion, a reinforcing proximal end, and a reinforcing distal end, the reinforcing proximal end being operably coupled to the proximal portion, and the reinforcing distal end being operably coupled to the distal portion.

20. The catheter according to claim 19, wherein the reinforcing member includes one of a frame-shaped member having a plurality of first annular members attached to a plurality of longitudinally extending intersecting members and spaced apart by the intersecting members, and a tubular coil-shaped member having a plurality of second annular members attached to a longitudinally extending coil and spaced apart by the coil.

21. The catheter according to claim 20, wherein the reinforcing member is formed from a laser-processed tube.

22. The catheter according to claim 19, wherein the longitudinal side portion extends along the axis, an opening is formed on the longitudinal side portion, and the tube extends from below the proximal portion through the opening of the reinforcing member to the outer surface.

23. The catheter according to claim 16, wherein the reinforcing member includes a thread wound around the tube and the breakout section.

24. The catheter according to claim 16, wherein the shaft includes an outer layer disposed on a support member and a reinforcing member.

25. The catheter according to claim 16, wherein the elongated tube includes a plurality of elongated tubes arranged radially apart on the outer side of the distal portion.

26. The catheter according to claim 16, wherein the inner member includes an inner surface, and the inner surface includes a liner layer.

27. The catheter according to claim 16, wherein the catheter includes one of a dilator and a guide catheter.

28. The catheter according to claim 16, wherein the shaft includes a distal tip portion having an ablation electrode assembly.

29. The catheter according to claim 16, wherein the electrode is a ring electrode.

30. A method for manufacturing a catheter, A step of forming the distal portion of an elongated member from an inner member defining a lumen, a proximal braided member, and a distal braided member positioned at a distance from the proximal braided member in a breakout section, wherein the proximal braided member and the distal braided member are positioned on the inner member, and the step of forming the distal portion, The steps include: attaching a long tube that extends longitudinally along the long member, extends inside the proximal braided member, extends longitudinally along the outside of the distal braided member, and passes through the breakout section; The steps include forming a reinforcing member on the breakout section, A method comprising the step of arranging an outer layer on the elongated member to form a shaft.

31. The method according to claim 30, wherein the reinforcing member is formed by winding a thread around the elongated member.

32. A system for tracking a catheter during electrophysiological procedures on a patient, A patch electrode that can be mechanically attached to the patient, A catheter that can be placed inside a patient's body, A long shaft having a lumen defined along its longitudinal axis and a distal portion, A proximal braided member including the distal end of the first braided member, A distal braided member having an outer surface and a proximal end of a second braided member, wherein the proximal end of the second braided member is arranged at a distance from the distal end of the first braided member in the longitudinal direction, A reinforcing member having an opening, a reinforcing proximal end, and a reinforcing distal end, wherein the reinforcing proximal end is operably connected to the distal end of the first braided member, and the reinforcing distal end is operably connected to the proximal end of the second braided member, and the elongated shaft includes the reinforcing member, An electrode positioned at the distal portion of the elongated shaft, A long tube extending longitudinally along the long shaft, The catheter includes a lead conductor disposed within the tube and electrically connected to the electrode, Here, the tube extends longitudinally along the proximal braid member radially below the proximal braid member, extends longitudinally on the outer surface along the distal braid member, and extends from within the lumen through the opening of the reinforcing member to the outer surface. A system comprising: a controller operably connected to the patch electrode and the tracking electrode, wherein the controller is configured to receive electrical signals and determine the position of the catheter relative to the patient.

33. The system according to claim 32, wherein the controller is further configured to generate an electroanatomical map of the patient's heart.

34. The system according to claim 32, wherein the controller is configured to determine the position of the catheter via an impedance-based process.

35. The system according to claim 32, wherein the reinforcing member is made of a different material from the proximal braided member and the distal braided member.

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