Catheter with a reinforced sheath and a connected tube

Abstract

A catheter is disclosed. The catheter includes an elongated shaft that defines a lumen and has a distal portion. The elongated shaft includes an outermost elongated support member coaxial with the lumen. The support member includes an outer portion. An electrode is positioned on the distal portion of the elongated shaft. An elongated tube extends longitudinally along the elongated shaft and is in interfacial contact with the support member along its outer portion. A lead conductor is positioned inside the tube and is electrically connected to the electrode. A coupling member is positioned around the tube and outside the support member so that the coupling member connects the tube to the support member.

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 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, in electrophysiological procedures, it includes guiding a catheter into the heart and tracking the position of the catheter relative to 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 include visualization of the heart, heart activity, and the position of the catheter within the heart. In a common visualization system, fluoroscopy is used, which can expose patients and clinicians to radiation. Electrical anatomical mapping is an alternative visualization technique that does not involve the use of radiation.

[0003] With electrical anatomical mapping, clinicians can accurately grasp the position of arrhythmias, define the geometric shape of the heart in three dimensions, draw anatomically relevant regions, and enable imaging for catheter positioning and manipulation. Catheters used with electrical anatomical mapping systems can include tracking functions such as navigation-compatible tracking methods or impedance-based tracking methods. Navigation-compatible catheters use magnetic sensors in the presence of a magnetic field to track the position and orientation of the catheter. 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 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 elongated shaft and 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 inside the tube and electrically connected to an electrode, and coupling members disposed around the tube and outside the support member, the coupling members coupling the tube to the support member.

[0005] In Example 2, the catheter in Example 1 includes a braiding material that forms a braided member. In Example 3, the connecting member in the catheter of Example 1 includes a long tube and one or more coils wound around a support.

[0006] In Example 4, in the catheter of Example 3, the elongated tube moves from below the connecting member on the support member upwards. In Example 5, the catheter in any of Examples 1 to 4 includes a connecting member, a tube, and a cover positioned on a support member.

[0007] In Example 6, the catheter in Example 5 has a cover made of polyether block amide and a binding member made of nylon. In Example 7, in any of the catheters in Examples 1 to 6, the elongated tube includes multiple elongated tubes spaced apart on the outside.

[0008] In Example 8, in any of the catheters in Examples 1-7, the elongated tube is joined to the braided member only along the outside. In Example 9, the electrode is a ring electrode in the catheter of Example 1.

[0009] In Example 10, the catheter in Example 1 includes a long tube which contains a mandrel placed inside the tube, and the mandrel allows the connecting member to be wound around the outside of the tube and the support member.

[0010] In Example 11, in either Example 1 or 10, the tube includes a distal end, and the distal end is occluded before the cover is applied. In Example 12, in the catheter of Example 11, the distal end of the tube is closed by a connecting member that is wound around the distal end of the tube and on the outside of the support member.

[0011] In Example 13, the catheter in Example 1 includes one support member in the shaft. In Example 14, in either the catheter in Example 1 or 13, the support member includes an inner surface, and the inner surface includes a liner layer.

[0012] 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. In Example 16, the catheter comprises 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 elongated shaft, an electrode positioned at the distal portion of the elongated shaft, and 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 positioned inside the tube and electrically connected to the electrode, and coupling members positioned around the tube and outside the support member, the coupling members coupling the tube to the support member.

[0013] In Example 17, in the catheter of Example 16, the support member includes a braided material that forms a braided member. In Example 18, the braided member in the catheter of Example 17 includes conductive fibers.

[0014] In Example 19, the connecting member in the catheter of Example 18 is a thread. In Example 20, in the catheter of Example 16, the elongated tube penetrates the braided member proximal to the shaft and crosses into the lumen.

[0015] In Example 21, the catheter of Example 16 includes a shaft, a coupling member, a tube, and a cover positioned on a support member. In Example 22, the catheter in Example 21 has a cover made of polyether block amide and a thread made of nylon.

[0016] In Example 23, the catheter of Example 16 includes multiple elongated tubes arranged radially on the outer surface. In Example 24, the support member is a liner layer in the catheter of Example 16.

[0017] In Example 25, the connecting member in the catheter of Example 16 includes a long tube and one or more coils wound around a support member. In Example 26, in the catheter of Example 25, the connecting member includes a first coil and a second coil, the first coil being wound in a first direction along the longitudinal direction of the support member, and the second coil being wound in a second direction along the longitudinal direction of the support member, the second direction being opposite to the first direction.

[0018] In Example 27, in the catheter of Example 25, the elongated tube moves from below the connecting member on the support member to above. Example 28 is a method for manufacturing a catheter, comprising the steps of preparing an elongated outermost support member for a shaft defining a lumen, the support member having an outer side, and attaching an elongated tube extending longitudinally along the elongated outermost support member, the attaching step comprising winding a coupling member around the elongated tube and the outside of the support member, the coupling member coupling the elongated tube to the support member.

[0019] Example 29 further includes the step of joining the elongated tube to the elongated outermost support member only along the outside, in the method of Example 28. Example 30 further includes the step of placing the mandrel inside the elongated tube before winding the connecting member, in the method of Example 28.

[0020] In Example 31, in the method of Example 28, the elongated tube includes a distal end, which is occluded before the cover is applied. In Example 32, in the method of Example 31, the distal end of the tube is closed by a connecting member that is wound around the distal end of the tube and the outside of the support member.

[0021] In Example 33, the cover is applied by a reflow process, in the same manner as in Example 32. Example 34 describes a system for tracking a catheter during electrophysiological treatment of a patient, comprising a patch electrode mechanically connectable to the patient, and a catheter that can be placed in the patient, comprising a long shaft defining a lumen and having a distal portion, the long shaft having an outermost long support member coaxial with the lumen, the support member having an outer portion, a tracking electrode positioned on the distal portion of the long shaft, the tracking electrode configured to be electrically connected to the patch electrode to generate an electrical signal, and a long tube extending longitudinally along the long shaft. A system is provided comprising: a catheter including a long tube which is joined to a support member along its outside; a lead conductor disposed inside the tube and electrically connected to an electrode, the lead conductor configured to transmit an electrical signal; and a coupling member disposed around the tube and outside the support member, the coupling member coupling the tube to the support member; and a controller operably connected to a patch electrode and a tracking electrode, the controller configured to receive an electrical signal and determine the position of the catheter relative to the patient.

[0022] In Example 35, in the system of Example 34, the controller is further configured to generate an electroanatomical map of the patient's heart. 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

[0023] [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, the features of the catheter embodiment of FIG. 2. [Figure 3B] It is a schematic diagram showing, in a perspective view, the features of the catheter embodiment of FIG. 3A. [Figure 4] It is a schematic diagram showing, in a side view, the features of another embodiment of the catheter of FIG. 2. [Figure 5] It is a schematic diagram showing, in a side view, the features of another embodiment of the catheter of FIG. 2. [Figure 6] It is a block diagram showing an exemplary method of manufacturing the medical imaging device of FIG. 2.

Modes for Carrying Out the Invention

[0024] The present invention is capable of following various modified forms and alternative forms, but 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 embrace all modified forms, equivalents, and alternative forms included within the scope of the present invention as defined by the appended claims.

[0025] 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.

[0026] 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, in this example, a long catheter assembly 100 including 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.

[0027] 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).

[0028] 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). In this example, catheter 105 is located within the sheath 110. Catheters 105 and 110 are movable relative to each other along their longitudinal axes.

[0029] 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.

[0030] 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.

[0031] 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., sinoatrial node or atrioventricular node)). In one exemplary embodiment, the EAM system 70 may include the RHYTHMIA® HDx mapping system, sold 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.

[0032] 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 embodiment, 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.

[0033] In other embodiments, impedance tracking methods can be used to track the locations of various devices. In such examples, the localization field is a group of independently oriented and spatially variable 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 locations 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.

[0034] 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.

[0035] 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.

[0036] 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 catheter placement 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.

[0037] This disclosure relates to a catheter and a method for assembling a catheter, including an insulating tube for housing conductive leads for a tracking electrode along the side of a support member on a catheter shaft. 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 may be encapsulated by a cover to which a reflow process is applied. The tube housing the conductive electrode can be easily positioned close to the tracking electrode, reducing the possibility of the conductive leads coming into contact with the conductive support member during manufacturing. This design allows for easier manufacturing because the tube is positioned outside the support member (often made from braided stainless steel fibers). Furthermore, the tube is more easily accessible because it is not located beneath a metal braid member and is covered only by a polymer layer.

[0038] Figure 2 shows one embodiment of a catheter 200 that can be used in an exemplary clinical environment 10 within a 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 an 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 portion 206, a longitudinal section 208, and a distal portion 210. The distal portion 210 includes a distal tip portion 212. The proximal portion 206 may be connected to a handle 214 located proximal to the shaft 202. An elongated flexible support member 220 is positioned on part or all of the shaft 202 along the longitudinal axis. In various embodiments, the support member 220 may be a flexible braid (e.g., stainless steel or high-strength polymer) or a hypo tube (e.g., laser-cut hypo tube).

[0039] The shaft 202 includes a plurality of components arranged along the distal portion 210. A long tube 222 extends longitudinally along the shaft 202 and houses a lead conductor 224 connected to a tracking electrode 226 located on the distal portion 208 of the shaft 202. In the illustrated embodiment, the distal portion 210 of the shaft 202 includes a plurality of tracking electrodes 226a.226n, each tracking electrode 226a.226n may be connected to a corresponding lead conductor housed in a corresponding tube that extends longitudinally along the shaft 202 and terminates at the proximal portion 206. The tracking electrode 226 is illustrated as a ring electrode on the shaft. In this example, the tracking electrodes 226a.226n are configured to be used with an impedance-based tracking system to detect the position of the catheter. In some embodiments, the tracking electrode 226 is also radiopaque. The schematicly shown connecting member 270 is positioned around the elongated tube 222 and outside the support member 220 to connect the elongated tube 222 to the support member 220. In various embodiments, the connecting member 270 is wound around the outside of the elongated tube 222 and the support member 220.

[0040] The proximal portion 206 or handle 212 may include an electrical connection that can be connected to an impedance-based tracking system such as the EAM system 70. In one example, the electrical connection is available under the trade name LEMO. The shaft 202 further includes a braided member 220 and a cover member 228 positioned on the tube 222 to form the outer surface 230 of the shaft 202.

[0041] The catheter 200 may include additional components for selected embodiments. In some embodiments, 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 an irrigation fluid supply source and a port for receiving the catheter into the main lumen 204. In some embodiments, the distal tip portion 212 may be configured as the tip of the dilator. In some embodiments, the shaft 202 may include a liner layer (not shown) located below a support member 220 and coaxial with the main lumen 204. In other embodiments, the liner layer is the support member 220, and the shaft 202 does not include a braided member or other member between the liner layer and the elongated tube 222. The liner layer may form the inner wall of the main lumen 204. In examples where 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 catheter 200 is configured as an ablation catheter, the proximal portion 206 or handle may be connected to an ablation energy source such as an electrical signal from console 130 or a cryogenic fluid. For example, the main lumen 204 may be configured to accommodate other electrical leads, such as leads to ablation electrodes or other sensors, steering wires, or conduits for irrigation fluid to the distal portion 210 along shaft 202. In some examples, the distal tip portion 212 may be configured to include an ablation electrode assembly or other sensors.

[0042] Figure 3A features a characteristic of one embodiment of the catheter 200, and Figure 3B includes a cross-sectional view of one embodiment of the catheter 200, such as the distal portion 210, along the line 3-3 in Figure 3A. In particular, the catheter 200 includes an elongated flexible shaft 202. The shaft 202 includes an elongated flexible support member 220 and a cover member 228, which are coaxial with the main lumen 204. In some embodiments, the shaft 202 is also coaxial with the main lumen 204 and includes a liner layer 240 that forms the inner wall of the main lumen 204. The support member 220 extends longitudinally along the shaft 202 and coaxially with the main lumen 204 and may be positioned on the liner layer 240, for example, directly on the liner layer 240. The support member 220 includes an inner or inner surface 250 positioned toward the main lumen 204, such as on the liner layer 240, and an outer or outer surface 252 positioned opposite the inner surface 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 this example, one support member 220 is also the outermost support member 220.

[0043] In this embodiment, the support member 220 is shown as a braided member 220, which imparts properties to the catheter 200 such as reduced twisting, creasing, or buckling of the shaft 202, and improves the balance of pushability, deflection, and torque transmission during rotation around the longitudinal axis A. In another example, the support member 220 may include a coiled shaft member, a laser-cut hypo tube, a liner layer, or other elongated shaft material. In the figure, the braided member as the support member 220 consists of a woven fabric 254 or a braided strand or layer of braided fibers 256 that forms gap spaces 258 between the fibers 256. The braided member as the support member 220 can be further characterized by the warp and weft threads, bias, and pick count per inch of the fibers 256. For example, in some embodiments, the pick count per inch may be maintained substantially uniformly along the entire longitudinal length of the braided member as the support member 220. In some embodiments, the number of picks per inch may vary along the longitudinal length of the braided member 220. The braided member as a support member 220 may consist of fibers 256 including stainless steel fibers such as conductive fibers, or high-strength polymer fibers, or may consist of layers of different materials.

[0044] The elongated tube 222 is coupled to the outermost support member 220 along its outer side 252. For example, the elongated tube 222 extends generally straight longitudinally along the outer side 252 of the outermost support member 220. The elongated tube 222 is in contact with the outer side 252 of the support member 220 by abutting against the material of the support member 220 or by being bonded to the support member 220. The elongated tube 222 is made of an insulating material such as a polymer and defines a lead lumen 260 that extends longitudinally along the length of the tube 222. The tube 222 is configured to house a lead conductor, such as a lead wire 262, within the lead lumen 260. The lead wire 262 is electrically connected to a tracking electrode 226 and is configured to transmit appropriate electrical signals from an electrical connector on the proximal portion 204 to the tracking electrode 226. In one embodiment, the elongated tube 222 has a substantially smaller diameter than the shaft 202, and the main lumen 204 has a substantially larger diameter than the lead lumen 260. In one embodiment of a catheter 200 including multiple tracking electrodes, an elongated tube for housing a lead wire is included for each tracking electrode. For example, the catheter may include two tracking electrodes and include a first elongated tube 222a housing a first lead wire 262a in a first lead lumen 260a, and a second elongated tube 222b housing a second lead wire 262b in a second lead lumen 260b. Multiple elongated tubes 222 may be arranged radially spaced on the outside 252 of the braided member 220. In the illustrated embodiment, the elongated tubes 222a, 222b are arranged radially spaced 180 degrees apart. The lead wires 262 are arranged inside the elongated tube 222, either as bare wires or as wires with an insulating coating. Each lead lumen 260 is terminated in close proximity to or at the corresponding tracking electrode.

[0045] 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 between the innermost and outermost support members or within the lumen 204 along the entire length of the shaft 202. In another embodiment, the elongated tube 222 contacts the outer side 252 of the outermost support member 220 at its distal portion 210, but traverses beneath the outermost support member 220 at its proximal portion 206. For example, the tube 222 can extend through the gaps 258 between the fibers 256 and travel within the lumen 240 or between the inner and outer braided members.

[0046] The connecting member 270 is positioned around the elongated tube 222 and on the outside 252 of the support member 220 to connect the elongated tube 222 to the support member 220. In various embodiments, the connecting member 270 is wound around the elongated tube 222 and the outside of the support member 220 to connect the elongated tube 222 to the support member 220. In other embodiments, the connecting member 270 is formed in a braided manner and positioned around the outside of the elongated tube 222 and the support member 220. In one example, the connecting member 270 connects the elongated tube 222 to the outside of the support member 220 during the manufacturing of the shaft 202, at least until the cover member 228 is positioned on the support member 220. For example, the connecting member 270 may be wound around the support member 220, coiled, braided, or coiled.

[0047] The connecting member 270 (e.g., thread, filament, or braid) may be made of a suitable material, and in one embodiment, it may be made of a material having tensile strength that does not break when the tube 222 is connected to the support member 220 and when subjected to additional manufacturing processes. For example, the material may have a high melting temperature that can withstand the reflow process for applying the cover member 228. In one embodiment, the connecting member 270 may include nylon type 6,6 having a monofilament structure and size USP (United States Pharmacopeia) 6-0, having proven tensile strength and withstanding melting at reflow temperatures. In addition, a transparent thread may remain hidden after the manufacturing of the shaft 202 and does not interfere with additional manufacturing processes such as drilling holes in the shaft, such as the support member 220. In additional embodiments, the thread may be selected to be radiopaque, nonconductive, or both. In one embodiment, a single coil winding along the length of the elongated tube 222 at a pitch of 4 mm was sufficient to secure the tube 222 to the support member 220.

[0048] The cover 228 or outer layer is positioned on the support member 220, the elongated tube 222, and the connecting member 270. In some embodiments, the cover 228 may be formed as a reflowable plastic or thermoplastic coating that extends over the support member 220, the elongated tube 222, and the connecting member 270, sealing the lower components of the shaft 202. For example, this coating may penetrate into the gaps 258 in the braided material of the support member 220 and onto the tube 222 by reflowing it onto the braided material of the support member 220 (e.g., onto the fibers 256 and the connecting member 270). In one example, the cover 228 is a polyether block amide, which in some examples is available under the trade names PEBAX from Arkema, SA, and VESTAMID E from Evonik Industries, AG.

[0049] Figure 4 shows features of other embodiments of the catheter 200, or the catheter 400 having a distal portion 410. Specifically, the catheter 400 includes an elongated flexible shaft 402. The shaft 402 includes an elongated flexible outermost support member 420 and a cover member 428, which are coaxial with the main lumen 404. The support member 420 includes an inner or inner surface 450 positioned toward the main lumen 404 and an outer or outer surface 452 positioned opposite the inner surface 450 and the main lumen 404. Embodiments of the support member include braided members, coiled members, laser-cut tubes, and liner layers. In some embodiments, the shaft 402 may include a plurality of concentric or coaxial support members, such as the innermost support member and the outermost support member 420. One support member 420 is also the outermost support member 420.

[0050] A long tube 422, extending longitudinally along a long shaft 402, is coupled to the outermost support member 420 along its outer side 452. For example, the long tube 422 extends longitudinally in a generally straight manner along the outer side 452 of the outermost support member 420. The long tube 422 contacts or interfacially contacts the outer side 452 of the support member 420 by abutting against the material of the support member 420 or by being bonded to the support member 420. The long tube 422 is made of an insulating material such as a polymer and defines a lead lumen 460 that extends longitudinally along the length of the tube 422. The tube 422 is configured to house a lead conductor, such as a lead wire 462, within the lead lumen 460. The lead wire 462 is electrically connected to a tracking electrode 426 and is configured to transmit appropriate electrical signals from a proximal electrical connector to the tracking electrode 426. The lead wire 462 is placed inside the elongated tube 422, either as a bare wire or as a wire with an insulating coating. The lead lumen 460 terminates in close proximity to or at the corresponding tracking electrode 426.

[0051] The connecting member 470 is positioned around the elongated tube 422 and on the outside 452 of the support member 420 to connect the elongated tube 422 to the support member 420. In various embodiments, the connecting member 470 is wound around the outside of the elongated tube 422 and the support member 420 to connect the elongated tube 422 to the support member 420. In the illustrated embodiment, the connecting member 470 is wound in a single coil around the elongated tube 422 and the support member 420 along the length of the shaft 402 or along at least a portion of the distal portion 410 as shown. The connecting member 470 (e.g., yarn, filament, or braid) may be made of a suitable material, and in one embodiment, it may be made of a material having tensile strength that does not break when the tube 422 is connected to the support member 420 and when subjected to additional manufacturing processes. In one embodiment, the bonding member 570 may include nylon type 6,6 having a monofilament structure and size USP (United States Pharmacopeia) 6-0, possessing proven tensile strength and withstanding melting at reflow temperatures.

[0052] The wound coupling member 470 can provide additional support to the shaft 402, particularly when the shaft 402 does not include a 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 an appropriate pitch to provide stability. The wound coupling member 470 can improve the balance of pushability, deflection, and torque transmission during rotation around the longitudinal axis A, in place of the braided fabric support member 420. In one embodiment, the wound coupling member 470 can extend distal to the distal 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 in the first section 474 of the support member 420 at the distal portion 410, and under the elongated tube 422 and over the support member 420 in the second section 476 of the support member 420 distal to the first section 474. In the illustrated embodiment, the elongated tube 422 transitions on its distal portion 410 from below the connecting member 470 in the first section 474 to above the connecting member 470 in the second section 476.

[0053] The cover member 428 or outer layer is positioned on the support member 420, the elongated tube 422, and the connecting member 470. In some embodiments, the cover 428 may be formed as a coating of a reflowable plastic or thermoplastic material that extends over the support member 420, the elongated tube 422, and the connecting member 470 and seals the lower layer components of the shaft 402.

[0054] Figure 5 features another embodiment of the catheter 200, or catheter 500 having a distal portion 510. Specifically, the catheter 500 includes an elongated flexible shaft 502. The shaft 502 includes an elongated flexible outermost support member 520 and a cover member 528, which are coaxial with the main lumen. The support member 520 includes an outer or outer surface 552 located on the inside and opposite to 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 surface 552. The tube 522 is configured to house a lead conductor, such as a lead wire, within the lead lumen, which is electrically connected to a tracking electrode (not shown).

[0055] The connecting member 570 is positioned around the elongated tube 522 and on the outside 552 of the support member 450 to connect the elongated tube 522 to the support member 520. In this embodiment, the connecting member 570 includes a plurality of threads, filaments, or braids wound around the outside of the elongated tube 522 and the support member 520, respectively, to connect the elongated tube 522 to the support member 520. In the illustrated embodiment, the connecting member 570 is wound around the elongated tube 422 and the support member 420 as a first coil 570a having a first pitch in a first direction, and as a second coil 570b having a second pitch 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, and the second coil 570b may be wound counterclockwise along the length of the support member 520. The connecting member 570 (e.g., yarn, filament, or braid) may be made of a suitable material, and in one embodiment, it may be made of a material having tensile strength that does not break when the tube 522 is connected to the support member 520 and when subjected to additional manufacturing processes. The coils 570a, 570b may be made of different materials or the same material. In one embodiment, the connecting member 570 may include nylon type 6,6 having a monofilament structure and size USP (United States Pharmacopeia) 6-0, having proven tensile strength and withstanding melting at reflow temperatures. A wound connecting member 570 having multiple coils can provide additional support to the shaft 502 than a single coil, particularly when the shaft 502 does not include a braided fabric support member 520 and the support member 520 is a liner layer. In this embodiment, the connecting member forms a reinforcing sheath, and the coils are wound at an appropriate pitch to provide stability. The wound connecting member 570 can improve the balance of pushability, deflection, and torque transmission during rotation around the longitudinal axis A, in place of the braided fabric support member 520.In the illustrated example, the connecting member 570 is wound over the elongated tube 522 and the support member in the first section 574 of the support member 520 at the distal portion 510, and under the elongated tube 522 and over the support member 520 in the second section 576 of the support member 520 distal to the first section 574. In the illustrated embodiment, the elongated tube 522 transitions from under the connecting member 570 in the first section 574 to over the connecting member 570 in the second section 576 at the distal portion 510.

[0056] The cover member 528 or outer layer is positioned over the support member 520, the elongated tube 522, and the multiple coils of the connecting member 570. In some embodiments, the cover 528 may be formed as a coating of a reflowable plastic or thermoplastic material that extends over the support member 520, the elongated tube 522, and the multiple coils of the connecting member 570 and seals the lower layer components of the shaft 502.

[0057] Figure 6 shows an exemplary method 600 for manufacturing a catheter. In one example, method 600 includes a method for constructing a catheter shaft having an outer and longitudinal support member defining a lumen, the outer of which is coupled to a tube defining a lead lumen, which includes a conductor lead configured to be attached to a tracking electrode on the catheter shaft. In one embodiment, in 602, an elongated support member, such as a support member 220 (e.g., a casing member), is prepared. The support member 220 may include a braided member. In 604, an assembly is created by coupling (e.g., attaching) a longitudinally extending elongated tube along the elongated support member, for example, by winding thread around the outside of the tube and the support member. Tools can be applied to the tube and support member to align the tube longitudinally along the tube while winding the thread around the tube and its outer surface. While the thread is being wound around the tube and its outer surface, a mandrel may be placed inside the tube to ensure that the lead lumen remains inside the tube even when the thread is tightly wound. In one embodiment, the mandrel can be removed after winding is complete.

[0058] In 606, the tubing and support member assembly is prepared to receive the cover. In this example, the distal end of the tubing is sealed to protect the lead lumen while the cover is applied. For example, the distal end of the tubing extends beyond the mandrel and may be tightly wrapped outwards with thread to seal the lead lumen of the tubing. Another embodiment of sealing the distal end of the tubing includes applying adhesive into the lead lumen at the distal end. The distal end of the tubing is sealed to reduce the possibility of the cover filling the lead lumen. In addition, as preparation for the cover, the end of the tubing may be reinforced to be held under tension against a long support member. In one example, the end of the tubing is secured to the support member by mounting members including tapes such as silicone tape, knots, molten extrusions, or heat-shrinkable tubing that is heated over the end. An example of heat-shrinkable tubing is medical heat-shrinkable tubing made of polyethylene terephthalate (PET). The cover may be applied via reflow. Mounting members may be removed after the cover 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.

[0059] 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 defined lumen and a distal portion, wherein the long shaft has an outermost long support member coaxial with the lumen, and the support member has an outer portion, An electrode positioned at the distal portion of the elongated shaft, A long tube extending longitudinally along the long shaft, wherein the long tube is connected to the support member along its outer side, A lead conductor disposed inside the tube and electrically connected to the electrode, A catheter comprising a coupling member disposed around the tube and outside the support member, wherein the coupling member connects the tube to the support member.

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

3. The catheter according to claim 1, wherein the connecting 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 moves from below to above the connecting member on the support member.

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

6. The catheter according to claim 5, wherein the cover comprises a polyether block amide and the bonding member comprises nylon.

7. The catheter according to any one of claims 1 to 6, wherein the elongated tube includes a plurality of elongated tubes arranged at intervals on the outer surface.

8. The catheter according to any one of claims 1 to 7, wherein the elongated tube is in contact with the braided member only along its outer edge.

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 comprises a mandrel disposed inside the tube, and the mandrel allows the connecting member to be wound around the outside of the tube and the support member.

11. The catheter according to claim 1 or 10, wherein the tube includes a distal end, and the distal end is occluded before a cover is applied.

12. The catheter according to claim 11, wherein the distal end of the tube is closed by the connecting member wound around the periphery of the distal end of the tube and on the outside of the support member.

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

14. The catheter according to claim 1 or 13, wherein the support member includes an inner surface, and the inner surface includes a liner layer.

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 defined lumen and a distal portion, wherein the long shaft has an outermost long support member coaxial with the lumen, and the support member has an outer portion, An electrode positioned at the distal portion of the elongated shaft, A long tube extending longitudinally along the long shaft, wherein the long tube is connected to the support member along its outer side, A lead conductor disposed inside the tube and electrically connected to the electrode, A catheter comprising a coupling member disposed around the tube and outside the support member, wherein the coupling member connects the tube to the support member.

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

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

19. The catheter according to claim 18, wherein the connecting member is a thread.

20. The catheter according to claim 16, wherein the elongated tube traverses through the braided member into the lumen at the proximal end of the shaft.

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

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

23. The catheter according to claim 16, wherein the elongated tube includes a plurality of elongated tubes arranged radially apart on the outer surface.

24. The catheter according to claim 16, wherein the support member is a liner layer.

25. The catheter according to claim 16, wherein the connecting 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 in a first direction along the longitudinal direction of the support member, and the second coil being wound in a second direction along the longitudinal direction of the support member, the second direction being opposite to the first direction.

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

28. A method for manufacturing a catheter, A step of preparing the outermost support member of the elongated shaft that defines the lumens, wherein the support member has an outer side, The step includes attaching a long tube that extends longitudinally along the long outermost support member, The mounting step includes winding a connecting member around the long tube and the support member, wherein the thread connects the long tube to the support member.

29. The method according to claim 28, further comprising the step of joining the elongated tube to the elongated outermost support member only along the outside.

30. The method according to claim 28, further comprising the step of placing a mandrel inside the elongated tube before winding the connecting member.

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

32. The method according to claim 31, wherein the distal end of the tube is closed by the connecting member which is wound around the distal end of the tube and the support member.

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

34. 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 defined lumen and a distal portion, wherein the long shaft has an outermost long support member coaxial with the lumen, and the support member has an outer portion, A tracking electrode positioned on the distal portion of the elongated shaft, wherein the tracking electrode is configured to be electrically connected to the patch electrode to generate an electrical signal, A long tube extending longitudinally along the long shaft, wherein the long tube is joined to the support member along its outer side, A lead conductor disposed within the tube and electrically connected to the electrode, wherein the lead conductor is configured to transmit the electrical signal, A connecting member disposed around the tube and outside the support member, wherein the connecting member connects the tube to the support member, and the catheter includes the connecting member, A system comprising: a controller operably connected to the patch electrode and the tracking electrode, wherein the controller is configured to receive the electrical signal 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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