Catheter with reinforced sheath with coupling tube

Abstract

A catheter is disclosed. The catheter includes an elongate shaft defining a lumen and having a distal end portion. The elongate shaft includes an outermost elongate support member coaxial with the lumen. The support member includes an outer side. An electrode is disposed on the distal end portion of the elongate shaft. An elongate tube extends longitudinally along the elongate shaft and interfaces with the support member along the outside. A lead conductor is disposed within the tube and electrically coupled with the electrode. A coupling member is disposed around an outer side of the tube and the support member such that the coupling member couples the tube to the support member.

Description

[0001] Cross-reference to related applications

[0002] This application claims the rights to U.S. Provisional Application No. 63 / 495,746, filed April 12, 2023, entitled “CATHETERS WITH REINFORCED SHEATH HAVING COUPLED TUBE”, and U.S. Provisional Application No. 63 / 592,780, filed October 24, 2023, both of which are incorporated herein by reference in their entirety. Technical Field

[0003] This disclosure relates to medical devices for catheter insertion procedures, such as those for electrophysiological procedures. More specifically, this disclosure relates to catheters and methods for manufacturing catheters. Background Technology

[0004] Various types of catheters are used in various medical fields to achieve access to physiological sites during medical procedures. For example, electrophysiological surgery involves guiding a catheter into the heart and tracking its position relative to the heart. Catheter ablation is a minimally invasive electrophysiological procedure used to treat various cardiac conditions, such as supraventricular and ventricular arrhythmias. Example catheters used in catheter ablation may include mapping catheters, ablation catheters, guiding sheaths, dilators, and other medical instruments, which may be referred to as catheters in this disclosure. Electrophysiological surgery can involve visualization of the heart, cardiac activity, and the location of the catheter within the heart. Common visualization systems involve the use of fluoroscopy, which exposes patients and clinicians to radiation. Electroanatomical mapping is an alternative visualization technique that does not involve the use of radiation.

[0005] Electroanatomical mapping allows clinicians to precisely pinpoint the location of arrhythmias, define cardiac geometry in three dimensions, delineate regions of interest for anatomical analysis, and permits catheter imaging for localization and manipulation. Catheters used with electroanatomical mapping systems can include tracking capabilities, such as navigation-enabled or impedance-based tracking methods. In the presence of a magnetic field, navigation-enabled catheters use magnetic sensors to track the catheter's position and orientation. However, not all catheters include magnetic sensors. In the presence of an electric field, impedance-based catheters use electrodes to track the catheter. Summary of the Invention

[0006] In Example 1, a catheter includes: an elongated shaft defining a lumen and having a distal portion, the elongated shaft having an outermost elongated support member coaxial with the lumen, the support member having an outer side; an electrode disposed on the distal portion of the elongated shaft; an elongated tube extending longitudinally along the elongated shaft, the elongated tube being coupled to the support member along its outer side; a lead conductor disposed within the tube and electrically coupled to the electrode; and a coupling member disposed around the outer side of the tube and the support member, the coupling member coupling the tube to the support member.

[0007] In Example 2, the conduit according to Example 1 is provided, wherein the support member comprises a braided material forming the braided member.

[0008] In Example 3, the conduit according to Example 1 is provided, wherein the coupling member comprises one or more coils wound around the elongated tube and the support member.

[0009] In Example 4, the conduit according to Example 3 is provided, wherein the elongated tube transitions from below to above the coupling member on the support member.

[0010] In Example 5, the conduit according to any one of Examples 1-4, wherein the shaft includes a cap disposed on the coupling member, the tube, and the support member.

[0011] In Example 6, the conduit according to Example 5 is provided, wherein the cap comprises polyether block amide and the coupling member comprises nylon.

[0012] In Example 7, the conduit according to any one of Examples 1-6, wherein the elongated tube comprises a plurality of elongated tubes spaced apart on the outer side.

[0013] In Example 8, the conduit according to any one of Examples 1-7, wherein the elongated tube is abutted against the braided member only along the outer side.

[0014] In Example 9, the catheter according to Example 1 is used, wherein the electrode is a ring electrode.

[0015] In Example 10, the conduit according to Example 1 includes an elongated tube comprising a mandrel disposed within the tube for enabling the coupling member to be wound around the outside of the tube and the support member.

[0016] In Example 11, the catheter according to any one of Example 1 or 10, wherein the catheter includes a distal end, wherein the distal end is closed before the cap is applied.

[0017] In Example 12, the conduit according to Example 11 is closed via a coupling member wrapped around the outside of the conduit and the support member.

[0018] In Example 13, the conduit according to Example 1 is provided, wherein the shaft includes a support member.

[0019] In Example 14, the conduit according to any one of Examples 1 and 13, wherein the support member includes an inner surface, and the inner surface includes a lining layer.

[0020] In Example 15, the catheter according to any one of Examples 1-14 is a guiding catheter having a proximal end coupled to a handle.

[0021] In Example 16, a catheter includes: an elongated shaft defining a lumen and having a distal portion, the elongated shaft having an outermost elongated support member coaxial with the lumen, the support member having an outer side; an electrode disposed on the distal portion of the elongated shaft; an elongated tube extending longitudinally along the elongated shaft, the elongated tube being coupled to the support member along its outer side; a lead conductor disposed within the tube and electrically coupled to the electrode; and a coupling member disposed around the outer side of the tube and the support member, the coupling member coupling the tube to the support member.

[0022] In Example 17, the conduit according to Example 16 is provided, wherein the support member comprises a braided material forming the braided member.

[0023] In Example 18, the conduit according to Example 17 is provided, wherein the braided component comprises conductive fibers.

[0024] In Example 19, the conduit is according to Example 18, wherein the coupling member is a wire.

[0025] In Example 20, the conduit according to Example 16 is provided, wherein an elongated tube passes through a braided member on the proximal side of the shaft and enters the lumen.

[0026] In Example 21, the conduit according to Example 16 is provided, wherein the shaft includes a cap disposed on the coupling member, the tube and the support member.

[0027] In Example 22, the conduit according to Example 21 is provided, wherein the cap comprises a polyether block amide and the thread comprises a wire.

[0028] In Example 23, the conduit according to Example 16 includes a plurality of elongated tubes radially spaced apart on the outer side.

[0029] In Example 24, the conduit is according to Example 16, wherein the support member is a lining layer.

[0030] In Example 25, the conduit according to Example 16 is provided, wherein the coupling member includes one or more coils wound around the elongated tube and the support member.

[0031] In Example 26, according to the conduit of Example 25, the coupling member includes a first coil and a second coil, the first coil being wound along the length of the support member in a first direction, and the coil being wound along the length of the support member in a second direction, the second direction being opposite to the first direction.

[0032] In Example 27, the conduit according to Example 25 is provided, wherein the elongated tube transitions from below to above the coupling member on the support member.

[0033] In Example 28, a method of manufacturing a conduit includes: providing an elongated outermost support member defining a lumen, the support member having an outer side; and attaching an elongated tube extending longitudinally along the elongated outermost support member; wherein the attachment includes wrapping a coupling member around the outer side of the elongated tube and the support member, the coupling member coupling the elongated tube to the support member.

[0034] In Example 29, the method according to Example 28 further includes docking the elongated tube to the elongated outermost support member only along the outer side.

[0035] In Example 30, the method described in Example 28 is further described, and includes setting a mandrel within the elongated tube prior to winding the coupling member.

[0036] In Example 31, according to the method of Example 28, the elongated tube includes a distal end, wherein the distal end is closed before the cap is applied.

[0037] In Example 32, according to the method of Example 31, the distal end of the tube is closed via a coupling member wrapped around the outside of the tube and the support member.

[0038] In Example 33, the method described in Example 32 is followed, wherein the cap is applied via a reflow process.

[0039] In Example 34, a system for tracking a catheter during an electrophysiological procedure on a patient includes: a patch electrode mechanically coupled to the patient; a catheter capable of being disposed within the patient's body, the catheter including an elongated shaft defining a lumen and having a distal portion; a tracking electrode disposed on the distal portion of the elongated shaft; an elongated tube extending longitudinally along the elongated shaft; a lead conductor disposed within the tube and electrically coupled to the electrode; a coupling member disposed on the outer side of the tube and a support member, the elongated shaft having an outermost elongated support member coaxial with the lumen, the support member having an outer side; the tracking electrode being configured to be electrically coupled to the patch electrode and generate an electrical signal; the elongated tube abutting the support member along the outer side; the lead conductor being configured to deliver the electrical signal; and the coupling member coupling the tube to the support member; and a controller operatively coupled to the patch electrode and the tracking electrode, the controller being configured to receive the electrical signal and determine the position of the catheter relative to the patient.

[0040] In Example 35, according to the system described in Example 34, the controller is further configured to generate an electroanatomical map of the patient's heart.

[0041] While several embodiments have been disclosed, other embodiments of the invention will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative embodiments of the invention. Therefore, the drawings and detailed description should be considered illustrative in nature rather than restrictive. Attached Figure Description

[0042] Figure 1 This is a diagram illustrating an exemplary clinical setup for treating a patient and for treating the patient's heart, the example clinical setup having an example electrophysiological system.

[0043] Figure 2 It shows what can be used for Figure 1 A schematic diagram of an example catheter for an example electrophysiological system.

[0044] Figure 3A Shown from the side view Figure 2 A schematic diagram illustrating the features of an embodiment of the catheter.

[0045] Figure 3B Shown from perspective Figure 3A A schematic diagram illustrating the features of an embodiment of the catheter.

[0046] Figure 4 Shown from the side view Figure 2 A schematic diagram showing the features of another embodiment of the catheter.

[0047] Figure 5 Shown from the side view Figure 2 A schematic diagram showing the features of another embodiment of the catheter.

[0048] Figure 6 It shows the manufacturing process. Figure 2 A block diagram of an example method for a medical imaging device.

[0049] While the invention is applicable to various modifications and alternatives, specific embodiments have been shown by way of example in the accompanying drawings and described in detail below. However, it is not intended to limit the invention to the specific embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives that fall within the scope of the invention as defined by the appended claims. Detailed Implementation

[0050] For the purpose of facilitating an understanding of the principles of this disclosure, reference is now made to the examples illustrated in the accompanying drawings, which are described below. The illustrative examples disclosed herein are not intended to be exhaustive or to limit this disclosure to the precise forms disclosed in the following detailed description. Rather, these exemplary embodiments have been chosen and described so that others skilled in the art may use their teachings. Using multiple (e.g., all) features from a particular example in all examples does not exceed the scope of this disclosure. Therefore, no single drawing should be construed as having any dependency or requirement relating to any individual component or combination of components illustrated therein. Furthermore, the various components depicted in the drawings may, in examples, be integrated with various components in other components depicted therein (or components not shown), all of which are within the scope of this disclosure.

[0051] Figure 1 An example clinical setup 10 is shown according to this disclosure for treating a patient 20 (such as treating the heart 30 of patient 20) using an electrophysiological system 50. The electrophysiological system 50 includes a catheter system 60 and an electroanatomical mapping (EAM) system 70. The example catheter system 60 includes an elongated catheter assembly 100, which in this example includes an ablation catheter 105 and a catheter sheath 110, and an electroporation console 130. Furthermore, the catheter system 60 includes various connecting elements, such as cables, that operatively connect the components of the catheter system 60 to each other and to components of the EAM system 70. Typically, the EAM system 70 includes a localization field generator 80, a mapping and navigation controller 90, and a display 92. Additionally, the clinical setup 10 may also include additional equipment (such as an imaging device 94 (represented by a C-arm)) and various controller elements (such as a foot controller 96) configured to allow an operator to control various aspects of the electrophysiological system 50. The clinical setup 10 may have… Figure 1 Other components not shown, and their arrangement.

[0052] 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 obtained through a blood vessel, such as a peripheral artery or vein. Once access to that blood vessel is obtained, the catheter 105 can be navigated into the patient's heart, such as into a ventricle.

[0053] Example catheter system 60 is configured to deliver ablation energy to target tissue in a patient's heart 30 to induce cell death in the tissue, such as rendering the tissue unable to conduct electrical signals. Elongated catheter assemblies (such as catheter assembly 100) may include multiple coaxially arranged catheters. For example, a catheter defines a longitudinal axis through the centroid of a cross-section of a catheter, such as the centroid of the cross-section of the axis of catheter 105 or the centroid of the cross-section of the main lumen of sheath 110. In this example, catheter 105 is disposed within sheath 110. Catheters 105 and 110 are movable relative to each other along their longitudinal axes.

[0054] Example catheter 105 includes an elongated catheter shaft and a distal end configured for deployment proximal to target tissue, such as within a chamber of a patient's heart. The distal end may include a basket-like structure, balloon, spline, shaped tip, or other deployment mechanism coupled to the shaft for achieving treatment. The deployment mechanism may include an electrode assembly or array having multiple ablation electrodes. Each of the multiple ablation electrodes is electrically coupled to a corresponding elongated lead conductor extending along the shaft to the proximal end of the catheter. The lead conductor may be electrically coupled to a plug in a proximal region of catheter 105, such as a plug configured, for example, directly or via an intermediate electrical conductor (such as a cable), mechanically and electrically coupled to console 130. In one example, console 130 is configured to provide electrical signals, such as multiple simultaneous or spatiotemporally separated electrical signals, to the electrically connected catheter 105, which travels along the lead conductor to spatially separated electrodes to achieve ablation.

[0055] Console 130 is configured to control aspects of the catheter system 60. Console 130 includes a controller, such as one or more controllers, processors, or computers, which executes instructions or code (such as processor-executable instructions) from a non-transitory computer-readable medium (such as a memory device or memory) to cause (such as control or execution) aspects of the electroporation catheter system 60. The memory may be part of one or more controllers, processors, or computers, or part of a memory device accessible via a computing network. Examples of computer networks include local area networks (LANs), wide area networks (WANs), and the Internet.

[0056] EAM system 70 may be operable to track the location of various components of catheter system 60 and generate high-fidelity three-dimensional anatomical and electroanatomical maps of the heart, including parts of the heart (such as the chambers of interest) or other structures of interest (such as the sinoatrial node or atrioventricular node). In one illustrative embodiment, EAM system 70 may include a RHYTHMIA™ HDx mapping system sold by Boston Scientific Corporation. Mapping and navigation controller 90 of EAM system 70 includes one or more controllers, such as a microprocessor or computer, that run code in memory to control or perform functional aspects of EAM system 70, wherein the memory may be part of one or more controllers, microprocessors, computers, or a memory device accessible via a computer network.

[0057] The EAM system 70 can generate a positioning field via a magnetic field generator 80 to define a positioning volume around the heart 30, and the output generated by a position sensor or sensing element on the tracking device (such as a sensor on the electroporation catheter 105) can be processed by a mapping and navigation controller 90 to track the position and orientation of one or more sensors and thus corresponding devices within the positioning volume. In the illustrated embodiment, device tracking is achieved using magnetic tracking technology, where the field generator 80 is a magnetic field generator that generates a magnetic field defining the positioning volume, and the position sensor on the tracked device is a magnetic field sensor.

[0058] In other embodiments, impedance tracking methods can be employed to track the position of various devices. In such examples, the positioning field is, for example, a set of independently oriented and spatially varying electric fields generated by an external field generator (such as surface electrodes), an in vivo or intracardiac device (such as an intracardiac catheter), or both. In these examples, position sensing elements can form tracking electrodes on the catheter being tracked, generating outputs received and processed by the mapping and navigation controller 90 to track the positions of various position sensing electrodes within the positioning volume. For example, the impedance tracking method can employ patch electrodes (not shown) attached to the patient's body, the underlying current or impedance being determined between the tracking electrode on the catheter and the patch electrode.

[0059] The EAM system 70 can be equipped with magnetic tracking capability, impedance tracking capability, or both. Regardless of the tracking method used, the EAM system 70 utilizes location information for various tracked devices, along with cardiac electrical activity acquired by, for example, an electroporation catheter 105 or another catheter or probe equipped with sensing electrodes, to generate and display via a display 92 a detailed three-dimensional geometric anatomical mapping or representation of cardiac tissue and spaces (such as cardiac chambers), and an electroanatomical map in which the cardiac electrical activity of interest is superimposed on the geometric anatomical mapping. Furthermore, the EAM system 70 can generate graphical representations of various tracked devices within the geometric anatomical mapping or electroanatomical map.

[0060] In the case of impedance-based tracking using the EAM system 70, the catheter includes a tracking electrode disposed on a deflectable portion of the catheter shaft. Multiple tracking electrodes can be employed on the deflectable portion of the catheter for the EAM system 70 to detect and recreate in-vivo catheter bends. In one example, each tracking electrode is coupled to a corresponding lead conductor or guide wire that extends along the shaft to the proximal portion where it is coupled to an electrical connector. The electrical connector can be coupled to the EAM system 70, for example, via a cable.

[0061] Several constraints are employed in the design and implementation of the tracking electrodes and associated lead conductors. Among these constraints are the electrical isolation of each tracking electrode and associated lead conductor from each other and from other conductive materials in the catheter, such as conductive braided members along the axial length. Furthermore, precise axial placement of the tracking electrodes is desirable. For example, the tracking electrodes may be radiopaque, and clinicians can use them to visualize catheter placement while using fluoroscopy. Additionally, the electrode positions and spacing relative to the catheter elements are programming parameters in multiple tracking and mapping software programs, and 3D reconstruction and modeling are performed using the electrode spacing as a constraint in the modeling curves. Therefore, the design and implementation of catheters using tracking electrodes can benefit from improved access to the lumen carrying the conductor leads.

[0062] This disclosure relates to a catheter and a method for assembling the catheter, the catheter comprising an insulating tube carrying conductive leads for a tracking electrode along the side of a support member on the catheter axis. The tube is coupled to the side of the support member, for example via a coupling member wound over the tube and the support member, and the tube, coupling member, and support member can be encapsulated via a cap applied using a reflow process. The tube carrying the conductive electrode can be easily positioned proximal to the tracking electrode, reducing the likelihood of the conductive leads contacting the conductive support member during manufacturing. This design facilitates easier manufacturing because the tube is placed outside the support member (typically made of braided stainless steel fibers). Furthermore, the tubes are easier to access because they are covered by only a single layer of polymer, rather than being positioned beneath a metal braided member.

[0063] Figure 2 An embodiment of catheter 200 in catheter assembly 100 for use in example clinical setup 10 is shown. For example, catheter 200 may be further configured as a guide catheter, dilator, ablation catheter, or other flexible, deflectable medical instrument that can be tracked via an impedance tracking system such as EAM system 70. Catheter 200 includes an elongated shaft 202, such as an elongated and flexible shaft 202 defining a longitudinal axis A. Shaft 202 also defines a main lumen 204 along longitudinal axis A and has a proximal portion 206, a longitudinal segment 208, and a distal portion 210. The distal portion 210 includes a distal tip portion 212. Proximal portion 206 may be coupled to a handle 214 proximal to shaft 202. An elongated and flexible support member 220 is disposed along the longitudinal axis above some or all of shaft 202. In various embodiments, support member 220 may be a flexible braid (e.g., stainless steel or high-strength polymer) or a hypotube (e.g., a laser-cut hypotube).

[0064] Shaft 202 includes a plurality of components disposed along distal portion 210. An elongated tube 222 extends longitudinally along shaft 202 and carries a lead conductor 224 coupled to a tracking electrode 226 disposed on distal portion 208 of shaft 202. In the illustrated embodiment, distal portion 210 of shaft 202 may include a plurality of tracking electrodes 226a…226n, each capable of coupling to a corresponding lead conductor carried in a corresponding tube extending longitudinally along shaft 202 and terminating at proximal portion 206. Tracking electrode 226 is illustrated as annular electrodes in the shaft. In the example, tracking electrodes 226a…226n are configured for use with an impedance-based tracking system to detect catheter positioning. In some embodiments, tracking electrode 226 is also radiopaque. A schematically illustrated coupling member 270 is positioned around the outside of elongated tube 222 and support member 220 to couple elongated tube 222 to support member 220. In various embodiments, the coupling member 270 is wound around the outside of the elongated tube 222 and the support member 220.

[0065] The proximal portion 206 or handle 212 may include an electrical connector that can be coupled to an impedance-based tracking system, such as the EAM system 70. In one example, the electrical connector may be available under the trademark name LEMO. The shaft 202 also includes a cap member 228 disposed above the braided member 220 and the tube 222 to form an outer surface 230 of the shaft 202.

[0066] The catheter 200 may include additional components for selected embodiments. In some embodiments, such as when the catheter 200 is configured as a guide sheath or dilator, the proximal portion 206 or handle 214 may include a hemostatic valve coupleable to an irrigation fluid source and a port for receiving the catheter within the main lumen 204. In some embodiments, the distal tip segment 212 may be configured as a dilator tip. In some embodiments, the shaft 202 may include a liner (not shown) below the support member 220 and coaxial with the main lumen 204. In other embodiments, the liner is the support member 220, and the shaft 202 does not include a braided member or other member between the liner and the elongated tube 222. The liner may define an inner wall of the main lumen 204. In examples such as where the catheter 200 is a guide sheath or dilator, the liner may be a thin-walled structure made of polytetrafluoroethylene (PTFE). In some examples, such as when catheter 200 is configured as an ablation catheter, the proximal portion 206 or handle may be coupled to a source of ablation energy, such as an electrical signal or cryofluid from console 130. For example, the main lumen 204 may be configured to carry other electrical leads, such as leads to ablation electrodes or other sensors, steering wires, or conduits along axis 202 leading to irrigation fluid in the distal portion 210. In some examples, the distal tip portion 212 may be configured to include an ablation electrode assembly or other sensors.

[0067] Figure 3A Features of an embodiment of catheter 200 are shown, and Figure 3B A cross-sectional view of an embodiment including catheter 200, such as along Figure 3A The distal portion 210 obtained by line 3-3. Specifically, the conduit 200 includes an elongated and flexible shaft 202. The shaft 202 includes an elongated and flexible support member 220 and a cap member 228, which are coaxial with the main lumen 204. In some embodiments, the shaft 202 includes a liner 240 that is also coaxial with the main lumen 204 and defines an inner wall of the main lumen 204. The support member 220 may extend longitudinally along the shaft 202 and be coaxial with the main lumen 204 and disposed on the liner 240, for example, such as directly disposed on the liner 240. The support member 220 includes an inner side or surface 250 disposed toward the main lumen 204, such as on the liner 240, and an outer side or surface 252 disposed opposite to the inner side 250 and the main lumen 204. In some embodiments, the shaft 202 may include a plurality of concentric or coaxial support members, such as an innermost support member and an outermost support member 220. In the example, the single support member 220 is also the outermost support member 220.

[0068] The support member 220 is illustrated in the embodiment as a braided member 220, which can provide properties to the conduit 200 such as reducing kinking, wrinkling, or warping of the shaft 202 and can provide an enhanced balance of pushability, deflectability, and torque transmission, such as during rotation about the longitudinal axis A. In another example, the support member 220 may include a coiled shaft member, a laser-cut thallium tube, a lining layer, or other elongated shaft material. In the illustration, the braided member serving as the support member 220 is constructed from a braided fabric 254 or layers of braided strands or fibers 256 forming gap spaces 258 between fibers 256. The braided member serving as the support member 220 can be further characterized by the warp and weft yarns and offset of the fibers 256, as well as the weft yarn per inch. For example, in some embodiments, the weft yarn per inch may be kept substantially uniform along the entire longitudinal length of the braided member serving as the support member 220. In some embodiments, the weft yarn per inch may vary along a portion of the longitudinal length of the braided member 220. The woven component 220, which serves as the support member, can be constructed from fibers 256, including stainless steel fibers, such as conductive fibers or high-strength polymer fibers, or as layers of different materials.

[0069] An elongated tube 222 is coupled to the outermost support member 220 along its outer side 252. For example, the elongated tube 222 extends longitudinally and generally straight along the outer side 252 of the outermost support member 220. The elongated tube 222 contacts the outer side 252 of the support member 220, such as by abutting against or being glued to the support member 220. The elongated tube 222 is configured with an insulating material, such as a polymer, and defines a lead lumen 260 extending longitudinally along the length of the tube 222. The tube 222 is configured to carry a lead conductor, such as a guide wire 262, within the lead lumen 260. The guide wire 262 is configured to be electrically coupled to a tracking electrode 226 and to carry an appropriate electrical signal from an electrical connector at a proximal portion 204 to the tracking electrode 226. In one embodiment, the elongated tube 222 has a diameter substantially smaller than that of the shaft 202, and the main lead lumen 204 has a diameter substantially larger than that of the lead lumen 260. In embodiments of the conduit 200 including multiple tracking electrodes, each tracking electrode includes an elongated tube carrying a guide wire. For example, the conduit may include two tracking electrodes and a first elongated tube 222a carrying a first guide wire 262a within a first lead wire lumen 260a and a second elongated tube 222b carrying a second guide wire 262b within a first lead wire lumen 260b. The multiple elongated tubes 222 may be radially spatially separated on the outer side 252 of the braided member 220. In the illustrated embodiment, the elongated tubes 222a and 222b are radially spaced 180 degrees apart. The guide wire 262 is disposed within the elongated tube 222 as a bare wire or with an insulating cover. Each lead wire lumen 260 terminates proximal to or at the corresponding tracking electrode.

[0070] The elongated tube 222 contacts the outermost support member 220 along its outer side 252. In one embodiment, the elongated tube 222 contacts the outer side 252 of the outermost support member 220 and does not traverse or enter the lumen 204 between the innermost and outermost support members along the entire length of the axis 202. In another embodiment, the elongated tube 222 contacts the outer side 252 of the outermost support member 220 in the distal portion 210, but otherwise traverses beneath the outermost support member 220 in the proximal portion 206. For example, the tube 222 may extend through the gap space 258 between the fibers 256 and travel into the lumen 240 or between the inner and outer braided members.

[0071] The coupling member 270 is positioned around the outer side 252 of the elongated tube 222 and the support member 220 to couple the elongated tube 222 to the support member 220. In various embodiments, the coupling member 270 is wound around the outer side of the elongated tube 222 and the support member 220 to couple the elongated tube 222 to the support member 220. In other embodiments, the coupling member 270 is formed as a braid and placed around the outer side of the elongated tube 222 and the support member 220. In one example, the coupling member 270 couples the elongated tube 222 to the outer side of the support member 220 during the manufacture of the shaft 202 until at least one cap member 228 is disposed on the support member 220. For example, the coupling member 270 may be wound, coiled, or braided around or coiled around the support member 220.

[0072] The coupling member 270 (e.g., wire, filament, or braid) can be constructed of a suitable material, and in one embodiment, it is formed of a material whose tensile strength will not break when the tube 222 is coupled to the support member 220 and when subjected to additional manufacturing processes. For example, the material may include one capable of withstanding the high melting temperatures of the reflow process used to apply the cap member 228. In one embodiment, the coupling member 270 may include a type 6,6 nylon with a monofilament construction and a size of USP 6-0, possessing proven tensile strength and resistance to melting during reflow temperatures. Furthermore, the clear wire can remain concealed after the manufacture of the shaft 202 and will not interfere with additional manufacturing processes, such as drilling into the shaft (e.g., into the support member 220). In additional embodiments, the wire may be selected as radial, non-conductive, or both. In one embodiment, a single pass of the coil along the length of the elongated tube 222 at a four-millimeter pitch is sufficient to secure the tube 222 to the support member 220.

[0073] A cap 228 or outer layer is disposed on the support member 220, the elongated tube 222, and the coupling member 270. In some embodiments, the cap 228 may be formed as a coating of a reflowable plastic or thermoplastic material that extends over the support member 220, the elongated tube 222, and the coupling member 270 and seals the underlying components of the shaft 202. For example, the coating may be exuded by reflowing over the braided material of the support member 220 (such as over the fibers 256 and the coupling member 270) and entering the gap space 258 of the braided material of the support member 220 and reaching the tube 222. In one example, the cap 228 is a polyether block amide and in some examples is available from the trademark name PEBAX from Arkema, SA and the trademark name VESTAMID E from Evonik Industries, AG.

[0074] Figure 4 Features of another embodiment of catheter 200 or catheter 400 having a distal portion 410 are shown. Specifically, catheter 400 includes an elongated and flexible shaft 402. Shaft 402 includes an elongated and flexible outermost support member 420 and a cap member 428, which are coaxial with the main lumen 404. Support member 420 includes an inner side or surface 450 disposed toward the main lumen 404, and an outer side or surface 452 disposed opposite to the inner side 450 and the main lumen 404. Embodiments of the support member include braided members, coiled members, laser-cut tubes, and lining layers. In some embodiments, shaft 402 may include a plurality of concentric or coaxial support members, such as an innermost support member and an outermost support member 420. A single support member 420 is also an outermost support member 420.

[0075] An elongated tube 422 extending longitudinally along an elongated axis 402 is coupled to an outermost support member 420 along an outer side 452. For example, the elongated tube 422 extends longitudinally and generally straight along the outer side 452 of the outermost support member 420. The elongated tube 422 contacts or abuts the outer side 452 of the support member 420, such as by abutting or being glued to the support member 420 by a material abutting against the support member 420. The elongated tube 422 is configured with an insulating material, such as a polymer, and defines a lead lumen 460 extending longitudinally along the length of the tube 422. The tube 422 is configured to carry a lead conductor, such as a guide wire 462, within the lead lumen 460. The guide wire 462 is electrically coupled to a tracking electrode 426 and configured to carry an appropriate electrical signal from an electrical connector at a proximal portion to the tracking electrode 426. The guide wire 462 is disposed within the elongated tube 422 as a bare wire or with an insulating cover. The lead lumen 460 terminates near or at the corresponding tracking electrode 426.

[0076] The coupling member 470 is positioned around the outer side 452 of the elongated tube 422 and the support member 420 to couple the elongated tube 422 to the support member 420. In various embodiments, the coupling member 470 is wound around the outside of the elongated tube 422 and the support member 420 to couple the elongated tube 422 to the support member 420. In the illustrated embodiment, the coupling member 470 is wound in a single coil around at least a portion of the length of the axis 402 or the distal portion 410, as illustrated. The coupling member 470 (e.g., thread, filament, or braid) may be constructed of a suitable material, and in one embodiment is formed of a material whose tensile strength is sufficient to prevent breakage when the tube 422 is coupled to the support member 420 and subjected to additional manufacturing processes. In one embodiment, the coupling member 570 may comprise a nylon type 6,6 having a monofilament construction and a size USP 6-0, which has proven tensile strength and resistance to melting during reflow temperatures.

[0077] The wound coupling member 470 can provide additional support to the shaft 402, especially if the shaft 402 does not include the braided fabric support member 420 and the support member 420 is a liner layer. In this embodiment, the coupling member forms a reinforcing sheath and the coil is wound at a suitable pitch to provide stability. The wound coupling member 470, instead of the braided fabric support member 420, provides an enhanced balance for pushability, deflectability, and torque transmission during rotation about the longitudinal axis A. In one embodiment, the wound coupling member 470 may extend distally to the furthest tracking electrode 426 to provide support. In the illustrated example, the coupling member 470 is wound over the elongated tube 422 and the support member 420 in a first segment 474 of the support member 420 on the distal portion 410, and wound below the elongated tube 422 and above the support member 420 in a second segment 476 of the support member 420 at the distal end of the first segment 474. In the illustrated embodiment, the elongated tube 422 transitions from below the coupling member 470 at the first segment 474 to above the coupling member 470 at the second segment 476 on the distal portion 410.

[0078] A cover member 428 or outer layer is disposed on the support member 420, the elongated tube 422, and the coupling member 470. In some embodiments, the cover 428 may be formed as a coating of reflowable plastic or thermoplastic material that extends over the support member 420, the elongated tube 422, and the coupling member 470 and seals the underlying component of the shaft 402.

[0079] Figure 5Features of another embodiment of catheter 200 or catheter 500 having a distal portion 510 are shown. Specifically, catheter 500 includes an elongated and flexible shaft 502. Shaft 502 includes an elongated and flexible outermost support member 520 and a cap member 528, which are coaxial with the main lumen. Support member 520 includes an outer side or surface 552 disposed opposite to the inner side and the main lumen. An elongated tube 522 extending longitudinally along the elongated shaft 502 is coupled to the outermost support member 520 along the outer side 552. Tube 522 is configured to carry a lead conductor, such as a guide wire, within the lead lumen, and the guide wire is electrically coupled to a tracking electrode (not shown).

[0080] A coupling member 570 is positioned around the outer side 552 of the elongated tube 522 and the support member 450 to couple the elongated tube 522 to the support member 520. In an embodiment, the coupling member 570 includes a plurality of threads, filaments, or braids, each wound around the outer side of the elongated tube 522 and the support member 520, to couple the elongated tube 522 to the support member 520. In the illustrated embodiment, the coupling member 570 is wound around the elongated tube 422 and the support member 420 as a first coil 570a having a first pitch and in a first direction, and as a second coil 570b having a second pitch and in a second direction opposite to the first direction. For example, the first coil 570a may be wound clockwise along the length of the support member 520, while the second coil 570b may be wound counterclockwise along the length of the support member 520. The coupling member 570 (e.g., wire, filament, or braid) can be constructed of a suitable material, and in one embodiment, it is formed of a material whose tensile strength is sufficient to prevent breakage when the tube 522 is coupled to the support member 520 and subjected to additional manufacturing processes. Coils 570a, 570b can be dissimilar or identical materials. In one embodiment, the coupling member 570 may comprise a nylon type 6,6 with a monofilament construction and USP 6-0 dimensions, possessing proven tensile strength and resistance to melting during reflow temperatures. A wound coupling member 570 with multiple coils can provide additional support to the shaft 502 on a single coil, particularly if the shaft 502 does not include the braided fabric support member 520 and the support member 520 is a lining layer. In this embodiment, the coupling member forms a reinforcing sheath and the coils are wound at a suitable pitch to provide stability. The wound coupling member 570, instead of the braided fabric support member 520, provides an enhanced balance for aspects such as pushability, deflectability, and torque transmission during rotation about the longitudinal axis A. In the illustrated example, the coupling member 570 is wound over the elongated tube 522 and the support member 520 in a first segment 574 of the support member 520 on the distal portion 510, and wound under the elongated tube 522 and over the support member 520 in a second segment 576 of the support member 520 at the distal end of the first segment 574. In the illustrated embodiment, the elongated tube 522 transitions from below the coupling member 570 at the first segment 574 to above the coupling member 570 at the second segment 576 on the distal portion 510.

[0081] A cover member 528 or outer layer is disposed on a plurality of coils of the support member 520, the elongated tube 522, and the coupling member 570. In some embodiments, the cover 528 may be formed as a coating of reflowable plastic or thermoplastic material that extends over the plurality of coils of the support member 520, the elongated tube 522, and the coupling member 570 and seals the underlying component of the shaft 502.

[0082] Figure 6An example method 600 for manufacturing a catheter is illustrated. In one example, method 600 includes a method of constructing a catheter shaft having a longitudinally extending support member with an outer side and defining a lumen, the outer side of the support member being coupled to a tube defining a lead lumen including conductor leads configured to be attached to a tracking electrode on the catheter shaft. In one embodiment, at 602, an elongated support member, such as support member 220 (e.g., a housing member), is provided. Support member 220 may include a braided member. At 604, a longitudinally extending elongated tube is coupled (e.g., attached) along the elongated support member, for example, by winding a thread around the outer side of the tube and support member to create an assembly. Tools may be applied to the tube and support member to align the thread longitudinally with the tube during winding the thread around the tube and outer surface. While the thread is wound around the tube and outer surface, a mandrel may be positioned within the tube to tightly wind the thread but maintain the lead lumen within the tube. In one embodiment, the mandrel may be removed after winding is complete.

[0083] At 606, the tube and support member assembly is prepared to receive the cap. In this example, the distal end of the tube is sealed to protect the lead lumen while the cap is applied. For example, the distal end of the tube may extend through the mandrel, and the distal end may be tightly wound with thread against the outside to seal the lead lumen of the tube. Other embodiments of sealing the distal end of the tube include applying adhesive into the lead lumen at the distal end. The distal end of the tube is sealed to reduce the possibility of the cap filling the lead lumen. Furthermore, the end of the tube may be reinforced to maintain tension against the elongated support member in preparation for the cap. In one example, the end of the tube is secured to the support member via an attachment member comprising tape (such as silicone tape, knots, melt extrusion, or heat shrink tubing applied over the end and heated). Examples of heat shrink tubing may include polyethylene terephthalate (PET) medical heat shrink tubing. The cap may be applied by reflow. The attachment member may be removed after the cap is applied. At 608, the lead conductor is placed into the lead cavity of the tube, and the lead conductor is electrically coupled to the tracking electrode disposed on the shaft.

[0084] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of this disclosure. For example, while the embodiments described above relate to specific features, the scope of the invention also includes embodiments with different combinations of features, as well as embodiments that do not include all of the described features. Therefore, the scope of the invention is intended to cover all such alternatives, modifications, and variations, as well as all equivalents thereof, that fall within the scope of the claims.

Claims

1. A catheter, comprising: An elongated shaft defining a lumen and having a distal portion, the elongated shaft having an outermost elongated support member coaxial with the lumen, the support member having an outer side; Electrodes disposed on the distal portion of the elongated shaft; An elongated tube extending longitudinally along the elongated axis, the elongated tube being coupled to the support member along the outer side; A lead conductor disposed inside the tube and electrically coupled to the electrode; as well as A coupling member is disposed around the outside of the tube and the support member, the coupling member coupling the tube to the support member.

2. The catheter according to claim 1, wherein, The support member includes a braided material that forms the braided component.

3. The catheter according to claim 1, wherein, The coupling member includes one or more coils wound around the elongated tube and the support member.

4. The catheter according to claim 3, wherein, The elongated tube transitions from below to above the coupling member on the support member.

5. The catheter according to any one of claims 1-4, wherein, The shaft includes a cover disposed on the coupling member, the tube, and the support member.

6. The catheter according to claim 5, wherein, The cap comprises polyether block amide and the coupling member comprises nylon.

7. The catheter according to any one of claims 1-6, wherein, The elongated tube comprises a plurality of elongated tubes spaced apart on the outer side.

8. The catheter according to any one of claims 1-7, wherein, The slender tube only connects to the braided component along its outer side.

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

10. The catheter according to claim 1, wherein, The elongated tube includes a mandrel disposed within the tube, which allows the coupling member to be wound around the outside of the tube and the support member.

11. The catheter according to any one of claims 1 or 10, wherein, The tube includes a distal end, wherein the distal end is closed before the cap is applied.

12. The catheter according to claim 11, wherein, The distal end of the tube is closed via a coupling member wrapped around the outside of the tube and the support member.

13. The catheter according to claim 1, wherein, The shaft includes a support member.

14. The catheter according to any one of claims 1 and 13, wherein, The support member includes an inner surface, and the inner surface includes a lining layer.

15. The catheter according to any one of claims 1-14, wherein, The catheter is a guide catheter with a proximal end coupled to a handle.

16. A catheter, comprising: An elongated shaft defining a lumen and having a distal portion, the elongated shaft having an outermost elongated support member coaxial with the lumen, the support member having an outer side; Electrodes disposed on the distal portion of the elongated shaft; An elongated tube extending longitudinally along the elongated axis, the elongated tube being coupled to the support member along the outer side; A lead conductor disposed inside the tube and electrically coupled to the electrode; as well as A coupling member is disposed around the outside of the tube and the support member, the coupling member coupling the tube to the support member.

17. The catheter according to claim 16, wherein, The support member includes a braided material that forms the braided component.

18. The catheter according to claim 17, wherein, The braided component includes conductive fibers.

19. The catheter according to claim 18, wherein, The coupling component is a line.

20. The catheter according to claim 16, wherein, The slender tube passes through the braided member on the proximal side of the shaft and enters the lumen.

21. The catheter according to claim 16, wherein, The shaft includes a cover disposed on the coupling member, the tube, and the support member.

22. The catheter according to claim 21, wherein, The cap comprises a polyether block amide and the coupling member comprises a nylon thread.

23. The catheter according to claim 16, wherein, The elongated tube comprises a plurality of elongated tubes radially spaced apart on the outer side.

24. The catheter according to claim 16, wherein, The supporting component is a lining layer.

25. The catheter according to claim 16, wherein, The coupling member includes one or more coils wound around the elongated tube and the support member.

26. The catheter according to claim 25, wherein, The coupling member includes a first coil and a second coil, the first coil being wound along the length of the support member in a first direction, and the coil being wound along the length of the support member in a second direction, the second direction being opposite to the first direction.

27. The catheter according to claim 25, wherein, The elongated tube transitions from below to above the coupling member on the support member.

28. A method of manufacturing a catheter, the method comprising: An elongated outermost support member is provided for a shaft defining a lumen, the support member having an outer side; as well as An elongated tube extending longitudinally along the outermost elongated support member; The attachment includes a coupling member wound around the outside of the elongated tube and the support member, the line coupling the elongated tube to the support member.

29. The method of claim 28, further comprising docking the elongated tube to the elongated outermost support member only along the outer side.

30. The method of claim 28, further comprising providing a mandrel within the elongated tube prior to winding the coupling member.

31. The method according to claim 28, wherein, The elongated tube includes a distal end, wherein the distal end is closed before the cap is applied.

32. The method according to claim 31, wherein, The distal end of the tube is closed via a coupling member wrapped around the outside of the tube and the support member.

33. The method according to claim 32, wherein, The cover is applied via a reflow process.

34. A system for tracking a catheter during an electrophysiological procedure on a patient, the system comprising: It can be mechanically coupled to the patient's patch electrode; A catheter that can be placed inside a patient's body, the catheter comprising: An elongated shaft defining a lumen and having a distal portion, the elongated shaft having an outermost elongated support member coaxial with the lumen, the support member having an outer side; A tracking electrode is disposed on the distal portion of the elongated shaft, the tracking electrode being configured to be electrically coupled to the patch electrode and generate an electrical signal; A long tube extending longitudinally along the elongated axis, the long tube abutting against the support member along the outer side; A lead conductor disposed within the tube and electrically coupled to the electrode, the lead conductor being configured to deliver the electrical signal; and A coupling member disposed around the outside of the tube and the support member, the coupling member coupling the tube to the support member; and A controller operatively coupled to the patch electrode and the tracking electrode, the controller being configured to receive the electrical signals and determine the position of the catheter relative to the patient.

35. The system according to claim 34, wherein, The controller is further configured to generate an electroanatomical map of the patient's heart.

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