Multi-electrode assembly with controlled folding mechanism

Abstract

The invention relates to a multi-electrode assembly with a controlled folding mechanism. The present disclosure relates to a catheter having a multi-electrode assembly having a high electrode density. The multi-electrode assembly may be a basket-shaped electrode assembly or a brush-shaped electrode assembly each having a plurality of spines. Each ridge includes a flexible core of shape memory material. The flexible wire may have a fold line that provides a controlled folding mechanism for collapsing the expanded electrode assembly into a delivery configuration.

Description

Technical Field

[0001] This invention relates to electrophysiological (EP) catheters, and more specifically, to EP catheters for cardiac mapping and / or ablation. More specifically, this invention relates to EP catheters having a multi-electrode assembly with a controlled folding mechanism. Background Technology

[0002] Electrophysiological catheters are commonly used to map electrical activity in the heart. Various electrode designs for different purposes are known. Specifically, catheters with basket electrode arrays are known and described, for example, in U.S. Patent Nos. 5,772,590, 6,748,255, and 6,973,340, the entire disclosure of each of which is incorporated herein by reference.

[0003] A basket catheter typically has an elongated catheter body and a basket-shaped electrode assembly mounted at the distal end of the catheter body. The basket assembly has a proximal end and a distal end, and includes multiple ridges connected at its proximal and distal ends. Each ridge includes at least one electrode. The basket assembly has an expanded arrangement in which the ridges are radially outwardly curved, and a collapsed arrangement in which the ridges are generally arranged along the axis of the catheter body.

[0004] The goal is for the basket assembly to detect as much electrical function as possible in the region where the electrode assembly is deployed (such as the left or right atrium) with as few heartbeats as possible (including a single heartbeat). By implementing more electrodes on the electrode assembly, a larger and more complete coverage area can be obtained accordingly. Furthermore, with an increased number of electrodes, it may be less necessary or even unnecessary to reposition the electrode assembly to reach the full desired area within the region. Increasing the number of electrodes is typically accompanied by an increase in the number of ridges or other structures supporting the electrodes. One problem with prior art designs with multiple ridges is that the movement of the ridges from an expanded, deployed state to a collapsed, delivered state can cause stress in the structure as the ridges transition between these two configurations. This stress can lead to undesirable damage to the device. Additionally, space within the catheter is very valuable. Having an increased number of ridges raises the question of how to orient these ridges within the catheter lumen when they collapse. Therefore, a multi-electrode assembly with an improved mechanism for controlling movement from the expanded to the collapsed state is needed to better predict the orientation of the ridges and electrodes within the lumen and to reduce material stress as the device transitions between these configurations. The technology disclosed herein satisfies this requirement, as well as other requirements described in the following materials. Summary of the Invention

[0005] This disclosure relates to a catheter comprising: an elongated catheter body extending along a longitudinal axis, the elongated catheter body having a proximal end and a distal end; and a flexible wire assembly positioned at the distal end of the elongated catheter body, formed of a shape memory material, the flexible wire assembly having a plurality of flexible wires, each flexible wire having a proximal end and a distal end, and wherein the flexible wire assembly has a plurality of folded wires positioned to facilitate the transformation of the flexible wire assembly from an expanded configuration to a delivery configuration. The catheter also includes a plurality of ridges formed by the plurality of flexible wires and a plurality of electrodes and wiring attached to each ridge.

[0006] In one aspect, the distal ends of multiple flexible lines are joined at the distal hub, and multiple folded lines are positioned on the multiple flexible lines adjacent to the distal hub.

[0007] In one aspect, multiple fold lines are positioned on multiple flexible lines near the proximal end of each flexible line.

[0008] In one aspect, a first plurality of fold lines are positioned on a plurality of flexible lines adjacent to the distal end of the conduit, and a second plurality of fold lines are positioned on a flexible line adjacent to the distal hub.

[0009] In one aspect, multiple fold lines are arranged concentrically or alternately near the far hub.

[0010] In one aspect, the flexible wire assembly includes a brush-shaped flexible wire assembly, wherein the distal end of each flexible wire is not attached to an adjacent flexible wire, and wherein a plurality of folded wires are positioned as proximal ends of an adjacent flexible wire assembly.

[0011] In one aspect, the brush-shaped conduit also includes an extension arm that engages with at least a portion of the proximal end of the flexible wire, and wherein at least one folded wire is positioned on each arm of the extension arm.

[0012] In one aspect, the fold lines are heat-shaped into shape memory materials, and can also be indentations or grooves, wherein the shape memory material can be a nickel-titanium alloy.

[0013] This disclosure also relates to a method for forming a catheter, the method comprising: forming an elongated catheter body; forming a flexible wire assembly having a plurality of flexible wires from a shape memory material; forming at least one folded wire on at least one of the plurality of flexible wires; heating the flexible wire assembly to heat-set the flexible wire assembly and the at least one folded wire; connecting a plurality of electrodes and wiring to each of the plurality of flexible wires to form a multi-electrode assembly; and connecting the multi-electrode assembly to a distal end of the elongated catheter body.

[0014] In one respect, the multi-electrode assembly can be a basket-shaped multi-electrode assembly or a brush-shaped multi-electrode assembly. Attached Figure Description

[0015] Other features and advantages will become apparent from the following and more specific description of preferred embodiments of the present disclosure, as shown in the accompanying drawings, and wherein similar reference characters generally refer to the same parts or elements throughout the views, and wherein: Figure 1 This is a top plan view of the catheter of the present invention according to one embodiment.

[0016] Figure 2 for Figure 1 A schematic diagram of the basket-shaped electrode assembly.

[0017] Figure 3 For from Figure 2 A schematic diagram of the flexible wire assembly of the basket electrode assembly.

[0018] Figure 4 A detailed view of a portion of a flexible line assembly according to another embodiment.

[0019] Figure 5 This is a schematic diagram of a brush electrode assembly according to another embodiment.

[0020] Figure 6 This is a schematic diagram of an invasive medical procedure using a multi-electrode assembly according to one implementation scheme. Detailed Implementation

[0021] First, it should be understood that this disclosure is not limited to specific exemplary materials, architectures, practices, methods, or structures, as these are all subject to variation. Therefore, while preferred materials and methods are described herein, many similar or equivalent options can be used in embodiments or practices of this disclosure.

[0022] It should also be understood that the terminology used herein is for the purpose of describing specific embodiments of this disclosure only and is not intended to be limiting.

[0023] The specific embodiments described below, in conjunction with the accompanying drawings, are intended as exemplary embodiments of this disclosure and are not intended to represent the only exemplary embodiments that may be practiced with respect to this disclosure. The term "exemplary" as used throughout this specification means "serving as an example, instance, or illustration" and is not necessarily to be construed as preferred or superior to other exemplary embodiments. The detailed description includes specific details intended to provide a thorough understanding of the exemplary embodiments of this specification. It will be apparent to those skilled in the art that the exemplary embodiments of this specification may be practiced without these specific details. In some instances, well-known structures and apparatuses are shown in the block diagrams to avoid obscuring the novelty of the exemplary embodiments presented herein.

[0024] For the sake of brevity and clarity only, directional terms such as top, bottom, left, right, up, down, above, above, below, under, rear, back, and front may be used relative to the accompanying drawings. These terms and similar directional terms should not be construed as limiting the scope of this disclosure in any way.

[0025] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains.

[0026] Finally, as used in this specification and the appended claims, unless otherwise expressly indicated by the content, the singular forms “a,” “an,” and “the” include the plural referents.

[0027] Multi-electrode assemblies are frequently used within cardiac chambers to analyze or map electrical activity. There is a desire to collect this type of data as quickly as possible to reduce procedure time and limit patient stress. Medical devices with multiple electrodes distributed across multiple ridges have been developed to shorten this procedure time. Increasing the number of ridges used to house the electrodes has created opportunities to better control the orientation of the ridges as they collapse into the lumen of the catheter and to reduce stress on the materials constituting the ridges. According to the technology disclosed herein, the ridges of a basket-shaped or brush-shaped multi-electrode assembly are configured with fold lines that control the collapse of the ridges into the catheter lumen with a known or predetermined orientation.

[0028] Now for reference Figure 1 The catheter 10 includes an elongated catheter body 12 having a proximal end and a distal end, and a control handle 14 located at the proximal end of the catheter body. The catheter 10 also includes an electrode assembly 16 located at the distal end of the catheter body 12. The electrode assembly 16 is a multi-electrode assembly including multiple ridges. In one embodiment, as... Figure 1 As shown, the electrode assembly 16 is a basket-shaped electrode assembly 16 having a plurality of ridges 18 (each ridge carrying a plurality of electrodes 20) and mounted at the distal end of the conduit 12. In another embodiment, as discussed below and as... Figure 5As shown, electrode assembly 16 includes a brush-shaped electrode assembly. The catheter body 12 includes an elongated tubular structure having a single axial or central lumen 26, but optionally multiple lumens if desired. To enable accurate mapping of electrical signals, it is desirable to provide an electrode array with a relatively high density. Thus, the number of ridges 18 employed can vary from four to sixteen or any other suitable number. The distal ends of the ridges 18 engage at a distal hub 22. The distal hub 22 can take any form to suit a particular application. In one embodiment, the distal hub 22 is generally circular and flattened to allow more electrodes 20 to contact the tissue to be mapped or treated. In another embodiment, the distal hub 22 is a cylindrical shape that allows the ridges to engage at multiple insertion points. The ridges 18 can be radially distributed uniformly or non-uniformly around the distal hub 22. Furthermore, each ridge 18 can include multiple electrodes 20, such as at least six and up to approximately 16 electrodes per ridge, or any other number of electrodes to suit a particular application. Similarly, the electrodes can be evenly distributed along the ridge or tilted toward the proximal, central or distal side to facilitate the analysis of the measured electrical signal.

[0029] The catheter body 12 is flexible, i.e., it can be bent, but is substantially incompressible along its length. The catheter body 12 can be of any suitable construction and can be made of any suitable material. One construction includes polyurethane or PEBAX. ® The outer wall is formed of polyether block amide. The outer wall includes an embedded braided mesh of stainless steel or the like to increase the torsional stiffness of the catheter body 12, such that the distal end of the catheter body rotates accordingly when the control handle 14 is rotated. The outer diameter of the catheter body 12 is not definitive, but should generally be as small as possible and not exceed about 10 French kilometres depending on the desired application. In one aspect, the total diameter of the catheter body 12 can be related to the number of electrodes 20 implemented by the electrode assembly 16 to accommodate associated electrical leads. For example, a twelve-ridge design with sixteen electrodes per ridge (a total of 192 electrodes), a ten-ridge design with sixteen electrodes per ridge (a total of 160 electrodes), and an eight-ridge design with sixteen electrodes per ridge (a total of 128 electrodes) can use a catheter body of up to 10.0 French kilometres. Similarly, the thickness of the outer wall is not definitive, but can be thin enough to accommodate pull wires, leads, sensor cables, and any other wires, cables, or tubes in the central lumen. If desired, the inner surface of the outer wall may be lined with a reinforcing tube (not shown) to provide improved torsional stability. U.S. Patent No. 6,064,905 describes and depicts examples of catheter body constructions suitable for use in conjunction with the present invention, the entire disclosure of which is incorporated herein by reference.

[0030] Ridge 18 comprises a shape memory material that facilitates an expanded arrangement, as described below. When the basket electrode assembly 16 is deployed, it expands, thereby bending outward to contact or be close to the wall of a chamber (such as the left atrium) in which the basket electrode assembly has been deployed.

[0031] In one aspect, the electrophysiologist may introduce the guiding sheath 24, guidewire, and dilator into the patient, as is commonly known in the art. For example, a suitable guiding sheath for connecting the catheter of the present invention is the French DiRex 10. ™ Guide sheath (available commercially from BARD, Murray Hill, NJ). Insert guidewire, remove dilator, and introduce catheter through guidewire sheath, whereby guidewire lumen 26 allows catheter to pass through guidewire. In an exemplary procedure, catheter is first introduced into the right atrium (RA) via the inferior vena cava (IVC), whereby catheter passes through septum (S) to reach the left atrium (LA).

[0032] As will be known, in the collapsed delivery position, the guide sheath 24 covers the ridge 18 of the basket electrode assembly 16, allowing the entire catheter to pass through the patient's vascular system to reach the desired location. Once the distal end of the catheter reaches the desired location, e.g., the left atrium, the guide sheath is withdrawn to expose the basket electrode assembly 16. After the guide sheath is withdrawn, the shape memory material of the basket electrode assembly causes the device to expand radially within the chamber. With the basket electrode assembly 16 radially expanded, the annular electrode 20 contacts the atrial tissue. As those skilled in the art will recognize, the basket electrode assembly 16 can be fully or partially expanded, upright, or deflected in various configurations, depending on the configuration of the cardiac region being mapped.

[0033] When the basket electrode assembly 16 expands, the electrophysiologist can map local activation time and / or perform ablation using electrode 20, which can guide the electrophysiologist in diagnosing and treating the patient. The catheter may include one or more reference ring electrodes mounted on the catheter body, and / or one or more reference electrodes may be placed outside the patient's body. By using a catheter with multiple electrodes on the basket electrode assembly, the electrophysiologist can map selected areas of the heart.

[0034] As used herein, the term "basket-shaped" to describe electrode assembly 16 is not limited to the configuration shown, but may include other designs such as spherical or egg-shaped designs, which include multiple expandable arms or ridges connected directly or indirectly at their proximal and distal ends. In one aspect, basket-shaped electrode assemblies of different sizes may be used depending on the patient's anatomy to fit closely to the area of ​​the patient being investigated, such as the right or left atrium. Other shapes for electrode assembly 16 are contemplated by the present invention. (The following is in...) Figure 5 The image shows a "brush-shaped" electrode assembly 16A.

[0035] A detailed view of one embodiment of the basket electrode assembly 16 is shown in Figure 2 As shown, the assembly has a total of eight ridges 18, each carrying ten electrodes 20. As mentioned above, in other embodiments, different numbers of ridges 18 and / or electrodes 20 may be used, and each ridge or electrode may be distributed uniformly or non-uniformly as needed. The distal ends of the ridges 18 engage at the distal hub 22. Correspondingly, the proximal ends of the ridges 18 may be secured to the distal end 32 of the catheter body 12. The lumen 26 may be used as a guidewire lumen. In some embodiments, the lumen 26 may also be used to supply a suitable flushing fluid, such as heparinized saline, to the basket electrode assembly 16. Accessories (not shown) in the control handle 14 may be provided to conduct flushing fluid from a suitable source or pump it into the lumen 26.

[0036] Each ridge 18 may include wiring with built-in or embedded leads having electrodes 20 carried by the ridge. The wiring has a core and multiple generally similar wires, each wire being covered by an insulating layer that enables each wire to be formed and functions as a conductor. The core provides a lumen in which other components (as discussed further in detail below) and / or additional leads, cables, tubing, or other components can pass through, such as a support structure in the form of flexible wire 28. Wiring suitable for use with the present invention is described in U.S. Application Serial No. 13 / 860,921, filed April 11, 2013, entitled “HIGH DENSITY ELECTRODE STRUCTURE,” and U.S. Application Serial No. 14 / 063,477, filed October 25, 2013, entitled “CONNECTION OF ELECTRODES TOWIRESCOILED ON A CORE,” the entire disclosure of which is incorporated herein by reference. Each wire (with embedded leads) can extend to the control handle 14 for appropriate electrical connection of the wire, thereby allowing detection of the signal measured by the electrodes 20.

[0037] Each ridge 18 may include a flexible wire 28 having a non-conductive cover 30, on which one or more annular electrodes 20 are mounted. Each annular electrode 20 may be configured as unipolar or bipolar, as known in the art. In embodiments, the flexible wire 28 may be formed of a shape memory material to facilitate transitions between an expanded (unfolded) configuration and a collapsed (delivered) configuration, and the non-conductive cover 30 may each comprise a biocompatible plastic tubing, such as polyurethane or polyimide tubing. Multiple flexible wires 28 may be joined to form a flexible wire assembly 29.

[0038] Figure 3One embodiment of the flexible wire assembly 29 is shown. The flexible wire assembly 29 includes a plurality of flexible wires 28. The distal end of each flexible wire 28 is engaged at a distal hub 22. In one embodiment, the flexible wire assembly 29 is made of nitinol (a nickel-titanium alloy). In this embodiment, the flexible wire assembly 29 is manufactured from a single nitinol tube. In another embodiment, the flexible wire assembly 29 is manufactured from a single nitinol sheet and formed in a basket shape. In still some embodiments, individual flexible wires 28 are manufactured and then engaged together at their distal ends to a hub to form the flexible wire assembly. In each of these embodiments, the proximal end of the flexible wire 28 is engaged to the distal end 32 of the conduit 12.

[0039] As mentioned above, the flexible wire assembly 29 is made of nitinol (a shape memory material). During manufacturing, the flexible wire assembly is heat-set into a "memorized" shape, also known as an unfolded shape or unfolded configuration. At body temperature, nitinol wires are flexible and elastic, and like most shape memory metals, they deform when subjected to minimal force and return to their shape when the force is absent. Figure 3 A flexible wire assembly 29 in the form of a memory shape or basket is shown. During manufacturing, the nitinol material is heated and formed into a basket shape. This shape is then heat-set, as is known in the art. The basket-shaped electrode assembly 16 will have a three-dimensional shape that is collapsible (deformable) to be fed into a guide sheath and then returns to its expanded shape memory configuration upon removal of the guide sheath when delivered to the desired area of ​​the patient. Those skilled in the art will recognize that other shape memory materials (e.g., other shape memory metals and shape memory polymers) can be used instead of nitinol.

[0040] Figure 3 A flexible wire assembly comprising multiple folded wires 36 is further illustrated. Each folded wire 36 comprises a portion of a nitinol wire or frame that folds or collapses at a specific location when subjected to minimal force. In one example, the minimal force may emanate from the guide sheath when the catheter or sheath is moved to cover the unfolded electrode assembly 16 and the electrode assembly is positioned in a delivery configuration. In another example, the force may emanate from the translation of a pull wire (not shown) having a distal end attached near the hub 22 and a proximal end operatively connected to the handle 14. In this embodiment, as the pull wire moves, the folded wires 36 will controllably bend or fold to cause the expanded electrode assembly 16 to collapse and fit within the guide sheath. In each embodiment, the collapse of the control device reduces or eliminates any ridge twisting and also minimizes any potential damage to the electrode that may occur if the electrode assembly 16 is forced into the guide sheath.

[0041] The number and position of the fold lines 36 will vary depending on the application of the specific device. Figure 3Two folded lines 36 are shown near the distal portion of the flexible line 28. For clarity, the folded lines 36 for each flexible line are not shown. The folded lines 36 are strategically placed along the flexible line 28 to allow for controlled transitions of the multi-electrode assembly from a delivery (deformation) configuration to an unfolded shape memory configuration. The folded lines can be placed along the flexible line 28 anywhere that facilitates the transition between the delivery and unfolding configurations. For example, the folded lines 36 can also be placed near the proximal portion 38 of the flexible line 28 to facilitate controlled collapse of the device. In another example, the folded lines 36 can be concentrically arranged and uniformly distributed between the flexible lines, or they can be arranged in a spiral pattern. The location may also depend on the position of the electrodes attached to the ridges.

[0042] The folded line 36 can be manufactured using several non-limiting methods. In one embodiment, the folded line 36 is a portion of the flexible line 28 that has been heat-set during the manufacturing process to fold in a direction that helps control the collapse of the electrode assembly. Figure 4 In another embodiment shown, the fold line may also include areas with slight indentations or grooves opposite to the folding direction. For example, when the folding direction is on the lumen side of the collapsible device, the fold line 36 may be located on the lumen-free side. In this embodiment, the indentations or grooves are not intended to reduce the amount of material forming the flexible line, but rather to move the material in a manner that facilitates the folding of the line. It will be apparent to those skilled in the art that the number and location of the fold lines along the flexible line 28 can depend on the purpose of the medical device, the number of ridges constituting the device, and the number of electrodes distributed on each ridge.

[0043] See now Figure 5 , Figure 5 Another embodiment of the flexible wire assembly 29A is shown, which can be used with the above-described embodiment. Figure 1 The described catheter configuration is used together. In this embodiment, the flexible wire assembly includes multiple folded wires 36A, indicated by dashed lines. In this embodiment, the brush electrode assembly unfolds in a substantially planar orientation that lays substantially flat on the tissue to be mapped or treated. The flexible wire assembly 29A includes multiple flexible wires 28A. Figure 5 A flexible wire assembly with four flexible wires 28A is shown. The flexible wire assembly 29A can be composed of any number of individual flexible wires to suit specific needs. For example, the flexible wire assembly 29A can have four, six, or up to sixteen flexible wires 28A. It should be understood that the position of each flexible wire 28A within the brush-shaped flexible wire assembly 29A determines whether a folding wire 36A will be used to help the device collapse in a controlled manner to fit within the guide sheath.

[0044] like Figure 5As shown, each flexible wire 28A positioned furthest from the center line CL includes a folded wire 36A. Those flexible wires 28A closest to the center line CL may or may not have a folded wire 36A, depending on their distance from the center line. It will be understood that the farther the flexible wire 28A is from the center line CL, the more necessary it is to have at least one folded wire 36A to help the device collapse. This increased need may be attributed to the length and angle of the extension arms 38A. For example, a flexible wire 28A1 located at distance D1 may not include a folded wire 36A. However, a flexible wire 28A2 located at distance D2 includes a folded wire 36A in its extension arm 38A due to the increased distance from the center line CL (D1 to D2). Additionally, for each extension arm 38A, the need for a folded wire 36A can also increase as the attachment angle α from the center line CL increases from 0° to 90°. Therefore, in the case of a device having any number of flexible wires 28A constituting the flexible wire assembly 29A, utilizing at least one folding wire 36A along the length of each extension arm 38A of each flexible wire will reduce the force required to collapse the device into the guide sheath.

[0045] Those skilled in the art will know that the above refers to Figures 2 to 5 Elements of each embodiment can be combined with other elements of other embodiments, and these combinations are all within the scope of this invention. The following describes... Figure 6 The same argument applies to each implementation scheme described above.

[0046] To help illustrate the use of the multi-electrode assembly 16 Figure 6 This is a schematic diagram of an invasive medical procedure according to an embodiment of the present invention. An electrode assembly 16 is provided at the distal end (see...). Figure 1 The catheter 10 may have a connector 60 at its proximal end, which can receive electrodes 20 from their respective electrodes (see...). Figure 1 The catheter 10 is wire-coupled to a console 62 for recording and analyzing the detected signals. An electrophysiologist 64 may insert the catheter 10 into the patient 66 to acquire electrode potential signals from the patient's heart 68. A specialist uses a control handle 14 attached to the catheter to perform the insertion. The console 62 may include a processing unit 70 that analyzes the received signals and presents the analysis results on a display 72 attached to the console. These results are typically in the form of a mapping, digital display, and / or graph derived from the signals.

[0047] In another aspect, the processing unit 70 may also receive signals from one or more position sensors 74 disposed near the distal end of the catheter 10, adjacent to the electrode assembly 16. Each of the one or more sensors may include a magnetic field-responsive coil or multiple such coils. Using multiple coils enables the determination of six-dimensional position and orientation coordinates. In response to a magnetic field from an outer coil, the sensor may thus generate an electrical position signal, enabling the processor 70 to determine the position (e.g., position and orientation) of the distal end of the catheter 10 within the cardiac cavity. An electrophysiologist can then observe the position of the electrode assembly 16 on an image of the patient's heart on a display 72. By way of example, this position sensing method can use CARTO ™ The system is implemented using a system manufactured by Biosense Webster Inc. (Diamond Bar, Calif.) and specifically described in U.S. Patent Nos. 5,391,199, 6,690,963, 6,484,118, 6,239,724, 6,618,612, and 6,332,089, PCT Patent Publication WO96 / 005768, and U.S. Patent Application Publications 2002 / 0065455 A1, 2003 / 0120150 A1, and 2004 / 0068178A1, the disclosures of which are incorporated herein by reference. Other position sensing techniques may also be employed, as will be appreciated. If desired, at least two position sensors may be positioned proximally and distally on the electrode assembly 16. The coordinates of the distal sensor relative to the proximal sensor can be determined, and other known information relating to the ridge 18 of the electrode assembly 16 is used to locate the position of each electrode in the electrode 20.

[0048] The above description has been presented with reference to the currently disclosed embodiments of the present invention. Those skilled in the art will recognize that changes and modifications can be made to the structures without intentionally departing from the principles, spirit, and scope of the invention. As will be understood by those skilled in the art, the drawings are not necessarily drawn to scale. Therefore, the specific embodiments described above should not be construed as suitable only for the precise structures shown in the drawings, but should be construed as conforming to and supporting the following claims, which have a full and fair scope of the invention.

Claims

1. A catheter, comprising: An elongated catheter body extending along a longitudinal axis, the elongated catheter body having a proximal end and a distal end; A flexible wire assembly, positioned at the distal end of the elongated conduit body, is formed of a shape memory material. The flexible wire assembly has multiple flexible wires, each having a proximal end and a distal end, and wherein the flexible wire assembly has multiple folded wires positioned to facilitate the transformation of the flexible wire assembly from an expanded configuration to a delivery configuration, wherein the folded wires are heat-set into the shape memory material. Multiple ridges formed by the aforementioned flexible wires; and Multiple electrodes and wiring are attached to each ridge, and the placement of each of the multiple folded lines depends on the number of electrodes distributed on each of the multiple ridges.

2. The catheter according to claim 1, characterized in that, The distal ends of the multiple flexible wires are joined at the distal hub.

3. The catheter according to claim 2, characterized in that, The multiple fold lines are positioned on the multiple flexible lines adjacent to the distal hub.

4. The catheter according to claim 2, characterized in that, The plurality of folded lines are positioned on the plurality of flexible lines adjacent to the proximal end of each flexible line.

5. The catheter according to claim 2, characterized in that, A first plurality of fold lines are positioned on the plurality of flexible lines adjacent to the distal end of the conduit, and a second plurality of fold lines are positioned on the flexible lines adjacent to the distal hub.

6. The catheter according to claim 2, characterized in that, Multiple fold lines are arranged concentrically adjacent to the distal hub.

7. The catheter according to claim 2, characterized in that, The multiple folded lines are arranged alternately on the multiple flexible lines.

8. The catheter according to claim 1, characterized in that, The flexible wire assembly includes a brush-shaped flexible wire assembly, wherein the distal end of each flexible wire is not attached to an adjacent flexible wire.

9. The catheter according to claim 8, characterized in that, The multiple folded lines are positioned adjacent to the proximal end of the flexible line assembly.

10. The catheter according to claim 9, characterized in that, It also includes extension arms that engage with at least a portion of the proximal end of the flexible line, and wherein at least one fold line is positioned on each of the extension arms.

11. The catheter according to claim 1, characterized in that, The shape memory material includes a nickel-titanium alloy.

12. A method for forming a catheter, comprising: Forming a slender duct body; A flexible wire assembly is formed from shape memory material, the flexible wire assembly having multiple flexible wires; At least one fold line is formed on at least one of the plurality of flexible lines, the fold line being positioned to facilitate the transformation of the flexible line assembly from an expansion configuration to a delivery configuration; Heating the flexible wire assembly to heat-set the flexible wire assembly and the at least one folded wire; Multiple electrodes and wiring are connected to each of the multiple flexible wires to form a multi-electrode assembly, wherein the placement of each of the at least one folded wires depends on the number of electrodes distributed on each of the multiple flexible wires. as well as The multi-electrode assembly is connected to the distal end of the elongated catheter body.

13. The method according to claim 12, characterized in that, The shape memory material includes a nickel-titanium alloy.

14. The method according to claim 12, characterized in that, The multi-electrode assembly is a basket-shaped electrode assembly.

15. The method according to claim 12, characterized in that, The multi-electrode assembly is a brush-shaped electrode assembly.

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