Steerable catheter with spine-reinforced molded articulation joint

Abstract

The electrophysiology catheter (100) comprises a tubular shaft (102) having a proximal portion and a distal portion having a distal end and a deflection region (108), the shaft defining a longitudinal axis and including an outer tubular jacket (402) and an articulation member (404) disposed within the jacket at the deflection region, the articulation member comprising a plurality of longitudinally disposed tubular segments (502), a plurality of first connecting segments (504) and a plurality of second connecting segments (506). Adjacent tubular segments are joined by respective first and second connecting segments, all disposed within a first plane extending through the longitudinal axis. A first reinforcing member (508) and a second reinforcing member (510) extend through the plurality of first and second connecting segments, respectively.

Description

[Technical field]

[0001] The present invention relates to medical devices and methods for catheters for medical procedures. More particularly, the present invention relates to devices and methods that include directional enhancements for catheters, such as steerable catheters. [Background technology]

[0002] Various medical procedures use catheters that are inserted into a patient's vascular system. In certain procedures, the catheter may be navigated through the vascular system to a target location within the body. The distal end of the catheter may be inserted into a patient's heart chamber, for example, in an interventional electrophysiology procedure. The distal end of the catheter may include one or more electrodes that are used to deliver therapy (e.g., ablation) or map the surface of the cardiac tissue (e.g., to locate cardiac tissue responsible for an arrhythmia). Accurately identifying and maintaining the position of the catheter, including its distal portion, may facilitate the performance of the catheter. Summary of the Invention

[0003] In Example 1, an electrophysiology catheter includes a tubular shaft having a proximal portion and a distal portion having a distal end and a deflection region. The shaft defines a longitudinal axis and includes an outer tubular jacket, an articulation member disposed within the jacket at the deflection region, and first and second reinforcing members. The articulation member includes a plurality of longitudinally disposed tubular segments, a plurality of first connecting segments, and a plurality of second connecting segments, each of the first and second connecting segments disposed between and connecting adjacent tubular segments, the first and second connecting segments disposed in a first plane extending through the longitudinal axis. The first reinforcing member and the second reinforcing member extend through the plurality of first and second connecting segments, respectively.

[0004] In Example 2, the electrophysiology catheter of Example 1, the first and second connecting segments are configured as a living hinge integrally formed with the tubular segment. In Example 3, the electrophysiology catheter of either Example 1 or 2, wherein the first and second reinforcing members are embedded within the first and second connecting segments and within the tubular segment, respectively.

[0005] In Example 4, the electrophysiology catheter of any of Examples 1-3, wherein the first and second stiffening members each comprise a helically wound flat ribbon wire. In Example 5, in the electrophysiological catheter of any of Examples 1 to 3, the first and second reinforcing members are stranded cables.

[0006] In Example 6, in the electrophysiological catheter of any of Examples 1 to 5, the first and second reinforcing members are embedded within the tubular segment by direct overmolding to form bonds with the first and second connecting members, and the bonds are further strengthened by an adhesive or a surface treatment.

[0007] In Example 7, in the electrophysiological catheter of any of Examples 1 to 6, the deflection region is configured to assume a curved shape when a deflection force is applied to the distal portion of the shaft, the curved shape lying in a second plane passing through the longitudinal axis, the second plane being perpendicular to the first plane.

[0008] In Example 8, the electrophysiological catheter of Example 7, wherein the first and second reinforcing members are configured to maintain the curved shape substantially aligned with the second plane upon receipt of the deflection force.

[0009] In Example 9, the electrophysiology catheter of any of Examples 1-8, wherein the first and second reinforcing members are configured to resist deviation of the distal portion of the shaft from the second plane.

[0010] In Example 10, the electrophysiological catheter of any of Examples 1-9 further comprises a handle attached to the proximal end of the tubular shaft, the handle including a steering actuator and a first steering wire extending through the tubular shaft, the first steering wire operably coupled to the steering actuator and fixed to the distal portion of the tubular shaft, and actuation of the steering actuator causes the first steering wire to apply a deflection force to the distal portion of the tubular shaft such that the deflection region assumes the curved shape.

[0011] In Example 11, the electrophysiology catheter of Example 10, wherein the first steering wire is circumferentially offset 90 degrees from the first and second stiffening members. In Example 12, the electrophysiology catheter of either Example 10 or 11 further comprises a second steering wire extending through the shaft, the second steering wire operably coupled to the steering actuator and fixed to the distal portion of the shaft, the second steering wire being circumferentially offset 180 degrees from the first steering wire such that the first and second steering wires lie in the second plane.

[0012] In Example 13, the electrophysiology catheter of any of Examples 7-12 further comprises a first steering wire lumen and a second steering wire lumen within the plurality of tubular segments around the first and second steering wires.

[0013] In Example 14, the electrophysiology catheter of any of Examples 1-13 further includes one or more ablation electrodes disposed at the distal end of the tubular shaft. In Example 15, the electrophysiology catheter of any of Examples 1-14, wherein the tubular segment further comprises a central lumen, and the outer tubular jacket further comprises an outer layer and a braided intermediate layer.

[0014] In Example 16, an electrophysiology catheter includes a tubular shaft having a proximal portion, a distal portion having a distal end, and a deflection region. The shaft defines a longitudinal axis and includes an outer tubular jacket, an articulation member, and first and second reinforcing members. The articulation member is disposed within the jacket at the deflection region and includes a plurality of longitudinally disposed tubular segments, a plurality of first connecting segments, and a plurality of second connecting segments, adjacent tubular segments being joined by respective ones of the first and second connecting segments, all of the first and second connecting segments being disposed in a first plane extending through the longitudinal axis. The first reinforcing member and the second reinforcing member extend through the plurality of first and second connecting segments, respectively.

[0015] In Example 17, the electrophysiology catheter of Example 16, wherein the first and second stiffening members are embedded within the first and second connecting segments and within the tubular segment, respectively.

[0016] In Example 18, the electrophysiology catheter of Example 17, wherein the first and second stiffening members each comprise a helically wound flat ribbon wire. In Example 19, the electrophysiology catheter of Example 17, wherein the first and second stiffening members are stranded cables.

[0017] In Example 20, the electrophysiological catheter of Example 17, wherein the first and second reinforcing members are embedded within the tubular segment by direct overmolding to form bonds with the first and second connecting members.

[0018] In Example 21, the electrophysiological catheter of Example 16, the deflection region is configured to assume a curved shape when a deflection force is applied to the distal portion of the shaft, the curved shape lying in a second plane passing through the longitudinal axis, the second plane being perpendicular to the first plane.

[0019] In Example 22, the electrophysiological catheter of Example 21, the first and second reinforcing members are configured to maintain the curved shape substantially aligned with the second plane under the deflection force.

[0020] In Example 23, the electrophysiology catheter of Example 21 further comprises first and second steering wire lumens extending through the tubular segment, each steering wire lumen configured to receive a steering wire configured to apply a deflection force to cause the deflection section to assume the curved shape, the first and second steering wires being circumferentially offset from the first and second stiffening members by approximately 90 degrees.

[0021] In Example 24, an electrophysiology catheter comprises a tubular shaft having a proximal portion and a distal portion having a distal end and a deflection region. The shaft defines a longitudinal axis and includes an outer tubular jacket, an articulation member disposed within the jacket at the deflection region, and first and second reinforcing members. The articulation member comprises a plurality of longitudinally disposed tubular segments and a plurality of living hinges, each of adjacent tubular segments being joined by a pair of living hinges, all of the living hinges disposed in a first plane extending through the longitudinal axis. The first and second reinforcing members extend through the plurality of living hinges.

[0022] In Example 25, the electrophysiology catheter of Example 24, wherein the first and second reinforcing members are embedded within the living hinge and the tubular segment, respectively. In Example 26, the electrophysiology catheter of Example 25, wherein the first and second stiffening members each comprise a helically wound flat ribbon wire.

[0023] In Example 27, the electrophysiology catheter of Example 26, wherein the first and second reinforcing members each comprise a rigid polymeric or metallic material. In Example 28, in the electrophysiological catheter of Example 26, the first and second reinforcing members are embedded within the tubular segment by direct overmolding to form bonds with the first and second connecting members.

[0024] In Example 29, the electrophysiological catheter of Example 26, the deflection region is configured to assume a curved shape when a deflection force is applied to the distal portion of the shaft, the curved shape lying in a second plane passing through the longitudinal axis, the second plane being perpendicular to the first plane.

[0025] In Example 30, the electrophysiology catheter of Example 29, wherein the first and second reinforcing members are configured to maintain the curved shape substantially aligned with the second plane upon receipt of the deflection force.

[0026] In Example 31, the electrophysiology catheter of Example 29 further includes a first steering wire lumen and a second steering wire lumen within the plurality of tubular segments configured to receive respective steering wires for applying a deflection force, the first and second steering wire lumens being circumferentially offset by approximately 90 degrees from the first and second stiffening members, respectively.

[0027] In Example 32, an electrophysiology catheter comprises a tubular shaft having a proximal portion and a distal portion having a distal end and a deflection region. The shaft defines a longitudinal axis and includes an outer tubular jacket, an articulation member disposed within the jacket at the deflection region, and first and second reinforcing members. The articulation member comprises a plurality of longitudinally disposed connected tubular segments. The first and second reinforcing members extend longitudinally through the tubular segments in a first plane extending through the longitudinal axis.

[0028] In Example 33, the electrophysiology catheter of any of Examples 32, wherein the first and second stiffening members each comprise a helically wound flat ribbon wire. In Example 34, the electrophysiology catheter of any of Example 33, wherein the first and second stiffening members are stranded cables.

[0029] In Example 35, in any of the electrophysiological catheters of Example 33, the first and second reinforcing members are embedded within the tubular segment by direct overmolding to form bonds with the first and second connecting members, and the bonds are further strengthened by an adhesive or surface treatment.

[0030] While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. [Brief description of the drawings]

[0031] [Figure 1] FIG. 1 is a diagram of an exemplary electrophysiology catheter consistent with various aspects of the present disclosure. [Diagram 2] 2 is a diagram of the electrophysiology catheter shown in FIG. 1 deflected in a first direction, consistent with various aspects of the present disclosure. [Diagram 3] FIG. 3 is a diagram of the electrophysiology catheter shown in FIGS. 1-2 deflected in a second direction, consistent with various embodiments of the present disclosure. [Figure 4] FIG. 1 is a side view of a portion of a shaft of an electrophysiology catheter including a deflection region, consistent with various aspects of the present disclosure. [Figure 5A] FIG. 13 is a top view of an articulation member of an electrophysiology catheter consistent with various aspects of the present disclosure. [Figure 5B] FIG. 1 is a cross-sectional view of a tubular segment of an electrophysiology catheter consistent with various aspects of the present disclosure. [Figure 5C] FIG. 1 is a side view of an articulation member of an electrophysiology catheter consistent with various aspects of the present disclosure. [Figure 5D]FIG. 13 is a detailed view of a portion of a side view of an articulation member of an electrophysiology catheter consistent with various aspects of the present disclosure. [Figure 6] FIG. 1 is another view of an exemplary electrophysiology catheter consistent with various aspects of the present disclosure. [Figure 7A] FIG. 1 is an embodiment of a side view of a portion of an articulation member of an electrophysiology catheter consistent with various aspects of the present disclosure. [Figure 7B] FIG. 13 is one embodiment of a side view illustrating a portion of an alternative embodiment of an articulation member of an electrophysiology catheter consistent with various aspects of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the specific embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

[0033] Detailed Description Various aspects of the present disclosure are directed to enhancing the directionality of catheters and steerable catheters. Once positioned within a patient's body, catheters and steerable catheters can be steered or curved in various directions. The present disclosure includes aspects that facilitate and enhance the directionality of catheters and steerable catheters. As described in more detail below, at least some of the catheters and steerable catheters can include direction-enhancing features that bias the catheters and steerable catheters in a desired direction when curved.

[0034] 1-3 are diagrams of an exemplary electrophysiology catheter 100 consistent with various aspects of the present disclosure. As shown in FIG. 1, the electrophysiology catheter 100 can be an electrophysiology steerable catheter 100. In certain examples, the electrophysiology catheter 100 can be steerable in one direction (e.g., direction A shown in FIG. 2) or multiple directions (e.g., directions A and B shown in FIGS. 2-3). The electrophysiology catheter 100 generally includes a tubular shaft 102 having a proximal portion 104 and a distal portion 106 sized and configured to be positioned and steered within a target region of a patient's heart. The distal portion 106 can be steerable. As shown, the distal portion 106 further includes a deflection region 108 and a distal end 110.

[0035] The tubular shaft 102, in an undeflected state, defines a longitudinal axis that generally corresponds to a geometric centerline of the tubular shaft 102. Additionally, in an undeflected state, the tubular shaft 102 may define mutually perpendicular planes (e.g., Cartesian planes) that extend through and intersect along the longitudinal axis of the tubular shaft 102. In one embodiment, as shown in FIG 1, the mutually perpendicular planes are represented by xy and yz axes, with the tubular shaft 102 defining the y-axis.

[0036] In certain examples, the tubular shaft 102 extends from a distal portion of a handle 112. An electrical cable or other suitable connector 114 extends from a proximal end of the handle 112 and can be coupled to an energy source or other device (not shown in FIG. 1) for transmitting one or more ablation signals. FIG. 1 illustrates generally one or more ablation electrodes 116 disposed at the distal end 110 of the distal portion 106.

[0037] A steering actuator 118 , such as a rotatable knob or plunger, which may be located at the distal end of the handle 112 , may be manipulated by the physician to deflect or position the steerable distal portion 106 of the tubular shaft 102 .

[0038] As shown in Figures 2-3, the electrophysiology catheter 100 is of a deflectable or steerable type. This allows the deflection region 108 to be deflected or curved by a user during use to facilitate placement of the distal end 110 and ablation electrode 116 at a desired target location within the heart. In some embodiments, deflection of the deflection region 108 can be achieved by manipulation of a steering actuator 118 that extends within the shaft 102 and is operatively connected to a steering element (e.g., a wire, tendon, ribbon, etc.) that is attached (directly or indirectly) to the shaft 102 at a location within the distal portion 106. The particular mode and structure for deflecting the deflection region 108 is not critical to the present disclosure, and therefore any technique, whether now known or later developed, may be used within the scope of the present disclosure.

[0039] During use, deflecting or bending the distal portion 106 may impart a torsional force that creates a torque or twist that moves the distal portion 106 away from or away from the target location. The tension of the curvature of the electrophysiology catheter 100 within the vasculature may cause the deflection region 108 to twist out of plane from the plane in which the distal portion 106 was positioned prior to deflection. As described in more detail below, the catheter 100 is configured such that the planarity of the deflection region 108 is maintained substantially along the yz plane.

[0040] 4 is a side view of a portion of a shaft 102 including a deflection region 108, consistent with various aspects of the present disclosure. As shown, the shaft 102 includes an outer tubular jacket 402 (shown in partial cutaway in FIG. 4) and an articulation member 404 disposed within the outer tubular jacket 402.

[0041] In a particular example, the outer tubular jacket 402 is of braided construction having a polymeric material reinforced with a metallic or polymeric braid formed from a plurality of interwoven wires that are woven, knitted, entangled, or otherwise intertwined with one another. Those skilled in the art will recognize that the use of braided jackets in catheter construction is well known and the particular details of the braid / jacket construction are not critical to the present disclosure. In some embodiments, the aforementioned braid can be omitted or other structures, such as reinforcing coils, can be used to increase the structural and torsional strength of the jacket 402.

[0042] 2-3, the articulation members 404 are configured to exhibit a relatively high degree of flexibility in the yz-plane while being relatively inflexible in the xy-plane such that when torsional forces on the shaft 102 attempt to deflect or bend the deflection region 108 in the xy-plane (or other planes oriented transverse to the yz-plane), the articulation members 404 resist those torsional forces, thereby facilitating a highly predictable planar deflection of the deflection region 108.

[0043] 5A is a top view of an articulation member 404 of an electrophysiology catheter 100 consistent with various aspects of the present disclosure. As shown, the articulation member 404 includes a plurality of longitudinally arranged tubular segments 502, a plurality of connecting segments 504, and a plurality of connecting segments 506. Adjacent tubular segments 502 are joined by respective connecting segments 504, 506. As shown, the connecting segments 504, 506 are disposed within an xy plane represented by a Cartesian coordinate system shown in conjunction with FIG. 5A when the articulation member 404 is in an undeflected state.

[0044] 5B is a cross-sectional view of the tubular segment 502 of the electrophysiology catheter 100 along line AA of FIG. 5A, consistent with various aspects of the present disclosure. As shown, the articulation member 404 includes a pair of reinforcing members 508, 510 extending therethrough. As further shown, the reinforcing members 508, 510 are embedded within the connecting segments 504, 506, respectively, and reinforce the connection between adjacent tubular segments 502, as described in further detail below.

[0045] As shown, the tubular segment 502 can include a pair of steering wire lumens 512, 514 disposed in a plane defined by y- and z-axes perpendicular to the xy-plane in which the connecting segments 504, 506 lie. As will be appreciated by those skilled in the art, the steering wire lumens 512, 514 are configured to receive steering wires or members operably connected to a steering actuator 118 (FIG. 1) to facilitate deflection of at least the deflection region 108 of the tubular shaft 102, as known in the art. In some embodiments, the segment 502 can include only one steering wire lumen.

[0046] As shown, the steering wire lumens 512, 514 (and thus the steering wires housed therein) are disposed diametrically opposite one another around the circumference of the articulation member 404. The steering wire lumens 512, 514 are thus circumferentially offset from one another by approximately 180 degrees, and are circumferentially offset from the stiffening members 508, 510, respectively, by approximately 90 degrees. In this configuration, the steering wire lumens 512, 514 lie in the yz plane.

[0047] Figure 5C is a side view of an articulation member 404 of an electrophysiology catheter 100, consistent with various aspects of the present disclosure. As shown, tubular segments 502 are connected via connecting segments 504, 506 that are disposed in a plane defined by the x-axis and y-axis, as represented by the Cartesian coordinate system shown in conjunction with Figure 5C. The articulation member 404 shown in Figure 5C is offset 90 degrees from the articulation member 404 shown in Figure 5A. This is also evidenced by rotating the x-axis and z-axis of these two views.

[0048] The connecting segments 504, 506 function as living hinges integrally formed with the tubular segment 502. Under a deflection force, the articulation member 404 can bend in a direction A along the yz plane. In certain embodiments, the articulation member 404 can bend in another direction B opposite to direction A along the yz plane. Whether the articulation member 404 is unidirectional or bidirectional is not critical to the present invention.

[0049] Regardless of which direction (e.g., A or B) the articulation member 404 bends, the living hinge forms a plurality of slits 522 and a plurality of slits 524 between each adjacent tubular segment 502 such that the bend articulates substantially in the yz plane. In some embodiments, the slits 522, 524 between different adjacent tubular segments 502 are the same. In other embodiments, the plurality of slits 522, 524 between different adjacent tubular segments 502 may be different to fine tune the articulation of the distal portion 106 of the tubular shaft 102. In some embodiments, the slits are concave and may be substantially "V-shaped" or substantially "U-shaped."

[0050] The living hinge design allows the articulation member 404 to exhibit a relatively high degree of flexibility in the yz plane while at the same time being relatively inflexible in the xy plane (the plane that passes through the living hinge). Thus, when torsional forces on the shaft 102 attempt to deflect or bend the deflection region 108 in the xy plane (or other planes oriented transverse to the yz plane), the plurality of slits 522, 524 facilitate the articulation member 404 having a highly predictable planar deflection of the deflection region 108 by resisting the torsional forces.

[0051] 5D is a detailed diagram of a portion of a side view of the articulation member 404 of the electrophysiology catheter 100, consistent with various aspects of the present disclosure. As shown, the reinforcing member 508 is embedded within the connecting segment 504 and within the tubular segment 502.

[0052] In some embodiments, the materials used for the living hinges can be relatively soft to minimize the possibility of stress-induced failure of the connecting segments 504, 506. Soft materials are prone to deformation during articulation, limiting fine movement capabilities as well as reducing overall durability. Thus, the reinforcing members 508, 510 are made of a harder material than the connecting segments 504, 506. In some embodiments, the reinforcing members 508, 510 each comprise a helically wound flat ribbon wire. In certain examples, the reinforcing members 508, 510 can comprise coils, stranded cables, stiffer polymeric materials, and other metal or polymeric components. In other examples, the materials used for the reinforcing members 508, 510 can be varied according to the specific requirements of the application.

[0053] In an embodiment, the tubular segment 502 may include a central lumen 516 centrally disposed within the tubular segment 502 along the tubular shaft 102. In certain examples, the central lumen 516 may include components such as one or more wires for ablation electrodes disposed along the tubular shaft 102, navigation components, temperature sensors (e.g., thermocouples), force sensors, radio frequency circuitry and / or wires, and cooling lumens. The central lumen 516 may be a working channel through which one or more devices can pass.

[0054] As shown, the central lumen 516 can be hourglass shaped. In some embodiments, the central lumen 516 can be substantially rounded or circular. A pair of steering wire lumens 512, 514 can be disposed on opposite sides of the central lumen 516.

[0055] In particular examples, the steering wire lumens 512, 514 may extend along the yz plane and may be aligned with the xy plane. The steering wire lumens 512, 514 are configured to receive steering elements (e.g., wires, tendons, ribbons made of stainless steel, titanium, MP35N, suitable alloys, and other suitable materials) for applying a deflection force to deflect or bend at least the deflection region 108 of the tubular shaft 102.

[0056] The deflection forces may twist or twist the deflection region 108 generally out of the yz-plane due to tension in the steering wire lumens 512, 514 and / or curvature of the electrophysiology catheter 100 within the vasculature. The connection segments 504, 506 are configured to maintain the planarity of the deflection region 108 in response to the curvature of the deflection region 108. The connection segments 504, 506 may stabilize the deflection region 108. For example, the connection segments 504, 506 may create a bias in the deflection region 108 to substantially align with the deflection. In certain examples, the connection segments 504, 506 may resist bending out of the yz-plane. The connection segments 504, 506 are configured to maintain the deflection region 108 generally in the yz-plane (e.g., within about + / - 10% of the plane) while the deflection forces bend or deflect at least the distal portion 106 of the tubular shaft 102. In certain examples, the connecting segments 504, 506 are configured to maintain the deflection region 108 substantially aligned (eg, within about + / - 10%) with the yz plane in response to a deflection force.

[0057] The connecting segments 504, 506 can maintain the planarity of the deflection region 108 and reduce the dependency on flatness of bending in the relatively low stiffness (e.g., polymeric material) of the tubular segment 502 of the tubular shaft 102. The connecting segments 504, 506 can maintain the curved shape of the deflection region 108 during deflection and can maintain the repeatability of achieving the curved shape of the deflection region 108 during deflection.

[0058] In some embodiments, the tubular segments 502 may be substantially the same length. In other embodiments, the length of the tubular segments 502 may be varied to customize or fine-tune the deflection shape of at least the deflection region 108 of the tubular shaft 102.

[0059] In some examples, the reinforcing members 508, 510 are embedded within the tubular segment 502 by direct overmolding to form a bond between the tubular segment 502 and the connecting members 504, 506. The bond between the tubular segment 502 and the connecting members 504, 506 can be further strengthened by application of adhesives, surface treatments, or others that can strengthen the bond.

[0060] Direct overmolding allows for a high strength bond between adjacent tubular segments 502 while still maintaining the desired flexibility. In some embodiments, the reinforcing members 508, 510 have a larger surface area due to being in a spirally wound flat ribbon shape, allowing for a stronger mechanical bond or lamination to the molded connecting segments 504, 506.

[0061] Thus, the tubular segments 502 may be made of a harder material to enhance durability and articulation feedback during use. For example, the tubular segments 502 may be made of polycarbonate (PC), acrylonitrile butadiene styrene (ABS), a PC / ABS blend, polyetheretherketone (PEEK), acetal, polyetherimide, or liquid crystal polymer (LCP).

[0062] The direct overmolding process significantly reduces processing time and operator interaction compared to individually splicing adjacent tubular segments 502 over the connecting segments 504, 506. This process allows for the inherent variability to be reduced by creating the entire articulation member 404 in one process. The mold can be sized to allow the reinforcing members 508, 510 to pass along the length of the part while preventing significant flow of material through the connecting segments 504, 506. Constraints at the connecting segments 504, 506 allow them to be molded with or without tension. Additionally, tabs or oval gates can be used at the parting line to allow flow through and / or around the reinforcing members 508, 510 to achieve proper containment. The reinforcing members 508, 510 prevent compression during articulation resulting in greater consistency after a higher number of cycles.

[0063] 6 is another view of an exemplary electrophysiology catheter 100 consistent with various aspects of the present disclosure. As described in detail above, the electrophysiology catheter 100 includes a tubular shaft 102 having a deflection region 108. The tubular shaft 102 includes an outer tubular jacket 402. In some embodiments, the outer tubular jacket 402 can include multiple layers (e.g., an outer layer made of TPE, TPU such as PEBA, or other material having a durometer less than 40D, and a braided middle layer of a high coverage, high picks per inch (PPI), multi-wire braid).

[0064] An articulation member 404 (shown in FIGS. 5A-D) is disposed within the deflection region 108. The articulation member 404 facilitates maintaining the planarity of the curvature of the deflection region 108. For example, the articulation member 404 is configured to generate a force perpendicular to the deflection (e.g., caused by a deflection force) that causes bending between the pair of reinforcing members 508, 510.

[0065] The articulation member 404, disposed within the deflection region 108 of the tubular shaft 102, operates to stabilize at least the distal portion 106 of the tubular shaft 102. In other examples, the articulation member 404 may extend along the length of the tubular shaft 102 or may extend within an intermediate section between the proximal and distal portions 104, 106.

[0066] The articulation members 404 embedded within the deflection region 108 of the tubular shaft 102 can cause the tubular shaft 102 to assume a curved shape when the tubular shaft 102 is disposed within the patient's vasculature. The ability to selectively curve the deflection region 108 can facilitate precise and effective delivery therapy (e.g., ablation) or map the surface of cardiac tissue (e.g., to locate cardiac tissue responsible for arrhythmia).

[0067] In some embodiments, the braided structure can function to strengthen the connecting segments 504, 506 during torsional or tensile loading. The combination of a high PPI braid in the middle layer and a low durometer material in the outer layer can increase the elasticity of the outer tubular jacket 402. The high elasticity of the outer tubular jacket 402 prevents excessive stress by allowing the outer tubular jacket 402 to stretch while reducing compression during articulation. However, the use of braided jackets in catheter construction is well known in the art, and the specific details of the braid / jacket structure are not critical to this disclosure. In some embodiments, the aforementioned braid can be omitted, or other structures, such as reinforcing coils, can be used to increase the structural and torsional strength of the jacket 402.

[0068] 7A is one embodiment of a side view of a portion of an articulation member 404 according to another embodiment of the present disclosure. As shown, the plurality of slits 702 are of a different shape than the plurality of slits 704 to allow for different bending radii in the regions of the articulation member 404 in which each of the plurality of slits is located. For example, in the illustrated embodiment, the slits 702 are narrower than the slits 704. As a result, when a biasing force is applied to bend the articulation member 404, the bending radius of the portion of the articulation member 404 that includes the slits 702 is greater than the bending radius of the portion that includes the slits 704. Thus, by selectively providing slits 702, 704 of different widths along different portions of the articulation member 404, the articulation member 404 can achieve multiple radii of curvature.

[0069] 7B is one embodiment of a side view of a portion of an alternative embodiment of the articulation member 404 that facilitates unidirectional or asymmetric curvature in the articulation member 404. As shown, the plurality of slits 706 are substantially closed gaps, e.g., when the articulation member 404 is in an undeflected state, the faces of the opposing tubular segments that the slits 706 span are in contact or are spaced apart but very close together. As further shown, the slits 708 are relatively wide. In this embodiment, the articulation member 404 is substantially inflexible in a direction toward the slits 706, but still allows the articulation member 404 to bend toward the slits 708. The articulation member 404 shown in this figure is relatively straight and does not deflect toward the side with the narrow slits 706, achieving substantially unidirectional bending. In other embodiments, the slits 706 and 708 can be selectively positioned along the articulation member 404 to allow the articulation member 404 to assume an asymmetric bending profile (e.g., the point of deflection in the bending direction toward the slit 706 is different than the point of deflection in the bending direction toward the slit 708). One skilled in the art will readily appreciate that further different configurations of the articulation member 404 and slits 706, 708 can be used to further tailor the bending profile as desired.

[0070] In other embodiments, slits of different cut widths, depths, shapes, and locations on either side of the articulation member 404 can be altered to fine-tune the bending characteristics and therefore create asymmetries in the bending or articulation motion.

[0071] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the above-described embodiments refer to certain features, the scope of the present invention also includes embodiments having different combinations of features or embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the claims, together with all equivalents thereof.

Claims

1. 1. An electrophysiology catheter comprising: a tubular shaft having a proximal portion and a distal portion having a distal end and a deflection region, the shaft defining a longitudinal axis; An outer tubular jacket; an articulation member disposed within the jacket at the deflection region, the articulation member including a plurality of longitudinally disposed tubular segments, a plurality of first connecting segments, and a plurality of second connecting segments, each of the first and second connecting segments being disposed between and joining adjacent tubular segments, the first and second connecting segments being disposed in a first plane extending through the longitudinal axis; and a first reinforcing member and a second reinforcing member extending through the first and second plurality of connecting segments, respectively; wherein the first and second connecting segments are configured as a living hinge integrally formed with the tubular segment.

2. An electrophysiological catheter as described in claim 1, wherein the living hinge forms a first plurality of slits and a second plurality of slits between adjacent tubular segments.

3. 3. The electrophysiology catheter of claim 1, wherein the first and second reinforcing members are embedded within the first and second connecting segments and within the tubular segment, respectively.

4. The electrophysiology catheter of any one of claims 1 to 3, wherein the first and second stiffening members each comprise a helically wound flat ribbon wire.

5. The electrophysiology catheter of any one of claims 1 to 3, wherein the first and second stiffening members are stranded cables.

6. the first and second reinforcing members are embedded within the tubular segment by direct overmolding to form bonds with the first and second connecting members; The electrophysiology catheter of any one of claims 1 to 5, wherein the bond is further strengthened by an adhesive or a surface treatment.

7. 7. The electrophysiology catheter of claim 1, wherein the deflection region is configured to assume a curved shape when a deflection force is applied to the distal portion of the shaft, the curved shape lying in a second plane passing through the longitudinal axis, the second plane being orthogonal to the first plane.

8. 8. The electrophysiology catheter of claim 7, wherein the first and second stiffening members are configured to maintain the curved shape substantially aligned with the second plane under the deflection force.

9. 9. The electrophysiology catheter of claim 1, wherein the first and second reinforcing members are configured to resist deviation of the distal portion of the shaft from the second plane.

10. a handle attached to the proximal end of the tubular shaft, the handle including a steering actuator; a first steering wire extending through the tubular shaft, the first steering wire operably coupled to the steering actuator and fixed to the distal portion of the tubular shaft; 10. The electrophysiology catheter of claim 1, wherein actuation of the steering actuator causes the first steering wire to apply a deflection force to the distal portion of the tubular shaft such that the deflection region assumes the curved shape.

11. The electrophysiology catheter of claim 10 , wherein the first steering wire is circumferentially offset 90 degrees from the first and second stiffening members.

12. 12. The electrophysiology catheter of claim 10, further comprising a second steering wire extending through the shaft, the second steering wire operably coupled to the steering actuator and fixed to the distal portion of the shaft, the second steering wire being circumferentially offset 180 degrees from the first steering wire such that the first and second steering wires lie in the second plane.

13. 13. The electrophysiology catheter of claim 7, further comprising first and second steering wire lumens within the plurality of tubular segments around the first and second steering wires.

14. The electrophysiology catheter of any one of claims 1 to 13, further comprising one or more ablation electrodes disposed at the distal end of the tubular shaft.

15. the tubular segment further comprises a central lumen; the outer tubular jacket further comprising an outer layer and a braided intermediate layer; An electrophysiological catheter according to any one of claims 1 to 14.

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