Steerable introducer with slide block partition

Abstract

A steerable introducer is described that is deflectable via a handle assembly. The handle assembly includes a slide member disposed within a slide chassis and coupled to a deflection wire that deflects the introducer, and a slide block divider for constraining the slide member. The slide block divider and slide chassis combine to form a slide compartment in which each of the first and second slide members are slidably disposed. The slide block divider can prevent the deflection wires from crossing each other within the handle assembly and can constrain each of the slide members during translation within the slide compartment to inhibit movement transverse to a longitudinal direction of the slide compartment. The slide block divider can provide improved handling of the steerable introducer.

Description

[Technical field]

[0001] Cross-reference to related application data This application claims the benefit under 35 USC § 119(e) of U.S. Provisional Application No. 63 / 323,744, filed March 25, 2022, and U.S. Provisional Application No. 63 / 396,297, filed August 9, 2022, the entire disclosures of which are incorporated herein by reference for all purposes.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to introducers and methods of using introducers, and more particularly to handle assemblies for steerable introducers and steerable sheaths, methods of manufacturing handle assemblies for steerable introducers and steerable sheaths, and methods of articulating steerable introducers and steerable sheaths. [Background technology]

[0003] Catheters are often used in medical procedures, such as, for example, diagnosis, therapy, ablation, etc. Typically, a physician advances a catheter through a patient's vascular system to a site of interest, such as a site within the patient's heart. The catheter may include one or more electrodes, one or more diagnostic devices, and / or one or more therapeutic devices, which may be used for any suitable medical purpose, including, but not limited to, ablation, diagnosis, cardiac mapping, etc.

[0004] For example, ablation therapy may be used to treat a variety of medical conditions. One medical condition for which ablation therapy may be used is the treatment of cardiac arrhythmias. When cardiac tissue is ablated, or at least subjected to ablation energy generated by an ablation generator and delivered by an ablation catheter, lesions are formed in the cardiac tissue. Electrodes attached to or within the ablation catheter may be used to induce tissue necrosis in cardiac tissue to improve conditions such as atrial arrhythmias (including, but not limited to, ectopic atrial tachycardia, atrial fibrillation, atrial flutter, etc.). Arrhythmias may lead to a variety of dangerous conditions, such as loss of synchronized atrioventricular contractions and stasis of blood flow. It is believed that the primary cause of atrial arrhythmias is stray electrical signals in the left or right atrium of the heart. An ablation catheter can be used to deliver ablative energy (e.g., radiofrequency energy, cryoablation, lasers, chemicals, high intensity focused ultrasound, etc.) to cardiac tissue to create lesions in the cardiac tissue and disrupt undesirable electrical pathways, thereby limiting or preventing stray electrical signals that lead to arrhythmias.

[0005] As another example, electroporation is a non-thermal ablation technique that applies an electric field to induce pore formation in cell membranes. The electric field can be applied in a train of relatively short duration pulses, for example, from nanoseconds to a few milliseconds. When electroporation is applied to tissue in vivo, cells in the tissue are exposed to a transmembrane potential to induce pore formation in the cell membrane. Electroporation can be reversible (i.e., the temporarily opened pores close again) or irreversible (i.e., the pores remain open), causing cell destruction. For example, in the field of gene therapy, reversible electroporation is used to transport high molecular weight therapeutic vectors into cells. In other therapeutic applications, irreversible electroporation is used to cause cell destruction.

[0006] The catheter may be introduced through an introducer or sheath. The introducer is advanced through the patient's vasculature, and the diagnostic and / or therapeutic catheter may be advanced through the lumen of the introducer to the desired site within the patient. The introducer itself may be advanced over a guidewire. The outer diameter of the introducer may be small enough to be advanced through the patient's vasculature, and may have a lumen large enough to be advanced through the catheter.

[0007] Catheters, such as diagnostic catheters, therapeutic catheters, or introducers, can include a steerable portion that can be selectively articulated to advance the catheter along a path, often a tortuous path, through a patient's vasculature. Typically, the steerable portion is located near the distal end of the catheter, and one or more tension cables are employed to transmit steering forces from the proximal handle assembly to the steerable portion. Examples of introducers with steerable portions are disclosed in U.S. Pat. Nos. 4,817,613 and 7,914,515, which are incorporated herein by reference in their entireties. Summary of the Invention [Means for solving the problem]

[0008] Described herein is a steerable introducer including a handle assembly having a slide member and a slide block divider for restraining the slide member. The steerable catheter includes an elongate body including a proximal end, a steerable portion, a first flexible lumen extending between the proximal end and the steerable portion, and a second flexible lumen extending between the proximal end and the steerable portion. A first flexible wire is disposed within the first flexible lumen and is operable to induce deflection of the steerable portion of the elongate body in a first direction. A second flexible wire is disposed within the second flexible lumen and is operable to induce deflection of the steerable portion of the elongate body in a second direction.

[0009] A handle assembly is coupleable to a proximal end of the elongated body. The handle assembly includes a handle housing, a slide chassis disposed within the handle housing, a first slide member drivably coupled to the first deflection wire, a second slide member drivably coupled to the second deflection wire, and a slide block partition disposed within the handle housing. An actuation assembly is drivably coupleable to each of the first and second slide members. The actuation assembly is operable to simultaneously drive the first slide member distally and the second slide member proximally within the slide compartment, or vice versa.

[0010] The slide block divider and the slide chassis combine to form a slide compartment in which each of the first and second slide members are slidably disposed. Advantageously, the slide block divider can prevent the first and second deflection wires from crossing each other within the handle housing. The slide block divider can restrain each of the first and second slide members from moving transversely to the longitudinal direction of the slide compartment during translation within the slide compartment. The slide block divider has a shape and size that cooperates with an inner surface of the handle housing to facilitate a compact housing assembly. The slide block divider also prevents the deflection wires from crossing each other and prevents the slide members from floating within the housing, so that no extra force is required on the actuation assembly to overcome torque or resistance from the deflection wires and slide members. Thus, a user can control the deflection of the elongated shaft portion with one hand. In this manner, the slide block divider can improve the handling of the steerable introducer during a medical procedure, such as, for example, a diagnostic, therapeutic, or ablation procedure.

[0011] The slide chassis includes a slide member opening extending along a length of the slide chassis. The opening is configured to receive at least one of the first slide member and the second slide member for installation on the slide chassis. The slide chassis includes a support edge configured to support the slide block partition. The slide member opening is at least partially defined by the support edge. The slide chassis includes a shoulder for positioning the slide block partition. The shoulder extends in a plane perpendicular to the support edge at an end proximate a distal end of the slide chassis. The slide chassis is substantially cylindrical.

[0012] The slide block partition includes fins extending toward the slide member to prevent rotation of the slide member and to prevent the first flexure wire from crossing the second flexure wire within the handle housing. The fins are radial projections that extend from a proximal end of the slide block partition to a distal end of the slide block partition and are disposed between the first and second slide members. The slide block partition includes an outer surface that interfaces with an inner surface of the handle housing. The inner surface of the handle housing has a curved shape, the curved shape having one or more ribs spaced apart from one another and extending along the curved shape. Thus, the outer surface of the slide block partition has a corresponding curved shape with slots to receive the one or more ribs of the inner surface of the handle housing and prevent relative movement of the slide block partition with respect to the handle.

[0013] The slide block partition may include a pair of rails. Each rail of the pair of rails extends along a length of the slide block partition and is configured to rest on the slide chassis. The slide block partition includes side walls extending along a length of the slide block partition. Each rail of the pair of rails is formed on a respective one of the side walls. The side walls of the slide block partition include tail portions configured to abut shoulders of the slide chassis to facilitate assembly and prevent relative movement between the slide block partition and the slide chassis. The slide chassis includes flat sides extending at least partially along a length of the slide chassis, with an inner surface of the side walls of the slide block partition contacting the flat sides.

[0014] The slide block partition has an extension at a proximal end thereof that is received in the gap to prevent the first deflection wire from crossing the second deflection wire during actuation of the steerable introducer. The slide chassis includes a slide member opening extending along a length of the slide chassis. The slide member opening is configured to receive installation of at least one of the first and second slide members onto the slide chassis.

[0015] The first slide member has an external right-hand thread and the second slide member has an external left-hand thread. The actuation assembly includes a rotatable knob having an internal thread configured to engage the external right-hand thread and the external left-hand thread. The first slide member includes a first slide member distal end side configured to slide along a first slide member side of the slide block partition to inhibit rotation of the first slide member within the slide compartment. The second slide member includes a second slide member distal end side configured to slide along a second slide member side of the slide block partition to inhibit rotation of the second slide member within the slide compartment. The first slide member includes a first flexible wire channel through which the first flexible wire extends and the second slide member includes a second flexible wire channel through which the second flexible wire extends. The first and second slide members are separated by a gap through which a portion of the slide block partition extends.

[0016] In some embodiments, the handle assembly further includes a first pin assembly having a first pin disposed at a proximal end of a first flexible wire channel of the first slide member and a second pin assembly having a second pin disposed at a proximal end of a second flexible wire channel of the second slide member. The first flexible wire is coupled to the first pin and the second flexible wire is coupled to the second pin. The handle assembly further includes a slide block divider having a fin extending radially toward the slide member. The fin has a height that extends radially downward and above the first and second pins. The height of the fin is constant along a longitudinal axis of the slide block divider. In some embodiments, the fin has a tapered shape to prevent the first and second pins from contacting the fin during sliding of the slide member. In some embodiments, each of the first and second pins includes a textured circumferential surface.

[0017] The foregoing general description and the following detailed description of exemplary embodiments are merely illustrative aspects of the teachings of the present disclosure and are not restrictive.

[0018] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more embodiments and together with this specification explain these embodiments. The accompanying drawings are not necessarily drawn to scale. Numerical dimensions illustrated in the accompanying graphs and figures are for illustration purposes and may or may not represent actual or preferred values ​​or dimensions. In some cases, some or all features may not be illustrated to aid in the description of the underlying features. [Brief description of the drawings]

[0019] [Figure 1] 1A-1D illustrate an introducer including a steerable portion and a handle assembly operable to articulate the steerable portion, according to some embodiments of the present disclosure. [Figure 2A] FIG. 2 is a close-up view of the handle assembly of FIG. 1; [Figure 2B] FIG. 2 is an exploded perspective view of the handle assembly of FIG. 1; [Diagram 3] FIG. 2 illustrates a housing portion of the handle assembly of FIG. 1. [Figure 4A] FIG. 2 illustrates a slide chassis of the handle assembly of FIG. 1. [Figure 4B] FIG. 2 illustrates a slide chassis of the handle assembly of FIG. 1. [Figure 5A] 2 illustrates a slide member and tension cable of the handle assembly of the introducer of FIG. 1. [Figure 5B] 2 illustrates a slide member and tension cable of the handle assembly of the introducer of FIG. 1. [Figure 6A] FIG. 2 illustrates a slide block divider of the handle assembly of FIG. 1; [Figure 6B] FIG. 2 illustrates a slide block divider of the handle assembly of FIG. 1; [Figure 6C] FIG. 2 illustrates a slide block divider of the handle assembly of FIG. 1; [Figure 6D] FIG. 2 illustrates a slide block divider of the handle assembly of FIG. 1; [Figure 6E] FIG. 2 illustrates a slide block divider of the handle assembly of FIG. 1; [Figure 6F] FIG. 2 illustrates a slide block divider of the handle assembly of FIG. 1; [Figure 7A] 2 illustrates the handle assembly of FIG. 1 without the slide block divider on the slide member. [Figure 7B] 2 illustrates the handle assembly of FIG. 1 with the slide block divider in place on the slide member. [Figure 7C] 2 is a front cross-sectional view of the handle assembly of FIG. 1 showing the slide compartment between the slide chassis and the slide block partition. [Figure 7D] 7D is a front cross-sectional view of the handle assembly of FIG. 1 showing the slide member assembled within the slide compartment of FIG. 7C. [Figure 8] FIG. 2 is a cross-sectional view taken along the longitudinal axis of the handle assembly of FIG. 1. [Figure 9] FIG. 1 is a partial view of a handle assembly including a slotted slide and a pin. [Figure 10A] 13A-13C illustrate another example of a sliding chassis of a handle assembly of an introducer including a steerable portion, according to some embodiments of the present disclosure. [Figure 10B] 10B is a diagram showing a slide member configured to be combined with the slide chassis of FIG. 10A. [Figure 10C] 10B is a diagram showing a slide member configured to be combined with the slide chassis of FIG. 10A. [Figure 10D] 10B and 10C in a handle assembly of an introducer including a steerable portion. FIG. [Figure 11] 13A-13C illustrate another slide block divider of a handle assembly of an introducer including a steerable portion, according to some embodiments of the present disclosure. [Figure 12] FIG. 12 is a partial view of a handle assembly including the slide block divider of FIG. 11 . [Figure 13]Schematic diagrams illustrating the use of a catheter passed through an introducer including a steerable portion and a handle assembly operable to articulate the steerable portion in a procedure on a patient, according to some embodiments of the present disclosure. [Figure 14] 1 is a schematic and block diagram of a system for electroporation therapy, according to some embodiments of the present disclosure. [Figure 15] 2 shows a pin assembly coupled to a slide member of a handle assembly of the introducer of FIG. 1; [Figure 16] FIG. 16 is a perspective view of the pin assembly of FIG. 15 . [Figure 17] FIG. 13 is a bottom perspective view of another example of a slide block divider according to some embodiments of the present disclosure. [Figure 18] FIG. 18 is a front view of the slide block divider of FIG. 17 . [Figure 19] 18 is a front cross-sectional view of the handle assembly of FIG. 1 showing the slide block divider of FIG. 17; [Figure 20] 18 is a cross-sectional view of the handle assembly of FIG. 1 with the slide block divider of FIG. 17 . [Figure 21] 17A-17C are diagrams illustrating examples of pins having textured circumferential surfaces that can be used in the pin assembly of FIG. 16. [Figure 22] 17A-17C are diagrams illustrating examples of pins having textured circumferential surfaces that can be used in the pin assembly of FIG. 16. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] The following description in conjunction with the accompanying drawings is intended as a description of various embodiments of the disclosed subject matter and is not necessarily intended to represent the only embodiment. In certain aspects, the present specification includes specific details for the purpose of providing an understanding of the disclosed embodiment(s). However, it will be apparent to those skilled in the art that the disclosed embodiment(s) can be practiced without these specific details. In some cases, well-known structures and components may be shown in block diagram form to avoid obscuring the concept of the disclosed subject matter.

[0021] References throughout the specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the disclosed subject matter. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily referring to the same embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Additionally, the embodiments of the disclosed subject matter are intended to include modifications and variations thereof.

[0022] It should be understood that terms such as "distal," "proximal," "upper," "lower," "front," "side," "length," "inner," and the like, that may be used herein, merely describe points of reference and do not necessarily limit embodiments of the present disclosure to a particular orientation or configuration. As used herein, "proximal" refers to a direction toward the end of the catheter or introducer closer to the clinician, and "distal" refers to a direction away from the clinician and (generally) into the patient's body. Additionally, terms such as "first," "second," "third," and the like, merely identify one of several parts, components, steps, operations, functions, and / or points of reference as disclosed herein, and similarly do not necessarily limit embodiments of the present disclosure to a particular configuration or orientation.

[0023] The terms "longitudinal," "axial," or "axially," as used herein to describe a relative position in relation to an introducer, catheter, introducer handle, or other components of the systems herein, generally refer to a longitudinal direction. For example, "longitudinal" or "axial" refers to an axis passing along the center of an introducer or catheter from the proximal end to the distal end, or along the center of an introducer handle from the proximal end to the distal end. The term "radial" generally refers to a direction perpendicular to the "axial" direction.

[0024] Described herein is an introducer that includes a steerable portion and a handle assembly that is operable to articulate the steerable portion. The catheter may be used in any suitable medical procedure, including, but not limited to, diagnostic and / or therapeutic procedures. Although the handle assembly may be described herein as being included in an introducer having a steerable portion, the handle assembly may be included in any suitable type of catheter, such as, for example, a diagnostic catheter, a therapeutic catheter, an introducer, etc.

[0025] Turning now to the figures, in which like reference identifiers relate to like elements, FIG. 1 illustrates an introducer 100 according to some embodiments of the present disclosure. The introducer 100 includes an elongate introducer shaft 110 having a distal end 102, a steerable portion 103 disposed adjacent the distal end 102, and a proximal end 104. The introducer 100 may be configured as any suitable type of catheter, including, for example, an introducer, a diagnostic catheter, or a treatment catheter. The introducer 100 includes a handle assembly 200 coupled to the introducer shaft 110 at the proximal end 104. As described herein, the handle assembly 200 is operable to selectively articulate the steerable portion 103 to accommodate advancement of the introducer shaft 110 through and / or retraction of the introducer shaft 110 from the patient's vasculature. In the illustrated embodiment, introducer 100 is configured as an introducer and further includes a connection hub 108 operably connected to an internal lumen (not shown) in handle assembly 200 for inserting another catheter (e.g., a diagnostic catheter, a therapeutic catheter), a fluid, or any other suitable medical substance or device known to those of skill in the art. Introducer 100 further includes a valve 112 operably connected to connection hub 108. One example of an introducer is discussed in detail in U.S. Patent 7,914,515, which is incorporated herein by reference in its entirety.

[0026] Referring now to the cross-sectional portion 100X shown in FIG. 1 , the introducer shaft 110 includes a first flexible lumen 131, a first flexible wire 141, a second flexible lumen 132, and a second flexible wire 142. Each of the first flexible lumen 131 and the second flexible lumen 132 extends between the proximal end 104 and the steerable portion 103 (or the distal end 102). The first flexible wire 141 extends within the first flexible lumen 131. The first flexible wire 141 is actuatable via the handle assembly 200 to induce deflection of the steerable portion 103 in a first direction (e.g., left or up). The second flexible wire 142 extends within the second flexible lumen 132. A second deflection wire 142 is actuatable via the handle assembly 200 to induce deflection of the steerable portion 103 in a second direction opposite to the first direction (eg, to the right or down).

[0027] Figure 2A shows a close-up view of the handle assembly 200. Figure 2B shows an exploded view of the handle assembly 200. Figure 8 is a longitudinal cross-sectional view of the handle assembly 200 showing an exemplary assembly of components therein.

[0028] 2A, the handle assembly 200 includes a handle housing 230 and an actuation assembly 220 axially coupled to the handle housing 230. The actuation assembly 220 includes a rotation knob 221. In some embodiments, the handle housing 230 includes a first housing portion 231 and a second housing portion 232 removably coupled to the first housing portion 231. The handle assembly 200 is coupled to the proximal end 104 of the introducer shaft 110. The handle assembly 200 includes a retaining nut 210 that is used to secure the introducer shaft 110 to the handle assembly 200. The introducer shaft 110 extends through the retaining nut 210 to an actuation hub 450 (shown in FIG. 2B). The handle assembly 200 can include a connector 208 at the proximal end of the handle assembly 200 in place of the connection hub 108. For example, in some embodiments, the connector 208 is an electrical connector configured to operably couple with a mating electrical connector coupled to a recording or monitoring device. The handle assembly 200 may include a channel 401 / 411 (see FIG. 8 ) through which electrical wire tubes (e.g., including the electrical wires exiting the introducer shaft 110) may extend to the connector 208.

[0029] 2B, the handle assembly 200 further includes a slide chassis 300 disposed within the handle housing 230 (e.g., within the first housing portion 231 and the second housing portion 232), a first slide member 400L drivably coupled to a first flexible wire (e.g., 131), a second slide member 400R drivably coupled to a second flexible wire (e.g., 132), and a slide block partition 500. The slide block partition 500 is disposed within the handle housing 230 (e.g., within the first housing portion 231 and the second housing portion 232). The slide block partition 500 and the slide chassis 300 combine to form a slide compartment 700 (shown in FIG. 7C) in which each of the first slide member 400L and the second slide member 400R is slidably disposed. The slide block partition 500 is configured to partially prevent the first and second flexure wires (e.g., 131 and 132) from crossing each other within the handle housing 230. The slide block partition 500 and the slide chassis 300 are also configured to constrain each of the first and second slide members 400L and 400R during translation within the slide compartment to inhibit movement of the first and second slide members 400L and 400R transverse to the longitudinal direction of the slide compartment 700. As shown in FIG. 7C, the slide compartment 700 is formed between the lumen portion of the slide chassis 300 and the slide block partition 500. The lumen portion of the slide chassis 300 is a portion of the lumen 310 between the distal end 301 and the proximal end 302 of the slide chassis 300 as shown in FIG. 4A.

[0030] 2A-2B, actuation assembly 220 is drivingly coupled to each of first slide member 400L and second slide member 400R. When actuation assembly 220 is rotated in a first direction, it simultaneously drives first slide member 400L distally and second slide member 400R proximally within slide compartment 700. When actuation assembly 220 is rotated in a second direction opposite the first direction, it simultaneously drives first slide member 400L proximally and second slide member 400R distally within slide compartment 700.

[0031] The rotation knob 221 is coupled to an actuation hub 450. The actuation hub 450 includes internal threads 452 configured to engage with the external right-hand and left-hand threads of the slide members (e.g., threads 412 and 422 in FIG. 5A). For example, the first slide member 400L may include an external right-hand thread (e.g., 412 in FIG. 5A) and the second slide member 400R may include an external left-hand thread (e.g., 422 in FIG. 5A). Thus, when the rotation knob 221 is rotated, the internal threads 452 engaged with the external right-hand and left-hand threads move the slide members 400L and 400R in opposite directions along the longitudinal axis of the handle housing 230.

[0032] 3 illustrates an exemplary internal structure of the handle housing portion 231 of the handle housing 230. The first and second handle housing portions 231 and 232 may have the same internal structure and / or may include cooperating features to facilitate assembly of the handle housing portions 231 and 232. For example, the inner surface 238 of the handle housing 230 may have a curved shape with one or more ribs spaced apart from one another and extending along the curved shape. In some embodiments, the handle housing 230 may be substantially cylindrical or tapered cylindrical for ease of one-handed handling.

[0033] As shown in FIG. 3, the first handle housing portion 231 has a proximal end 231p and a distal end 231d. The outer diameter of the first handle housing portion 231 tapers from the proximal end 231p to the distal end 231d. The inner surface 238 of the first handle housing portion 231 includes a plurality of ribs 233 spaced apart from one another and having a partially circular shape. The ribs 233 form a generally ring-like or circular shape when the handle housing portions 231 and 232 are assembled together. The ribs 233 enhance structural integrity and limit or prevent relative movement with other components (e.g., slide block divider 500). The one or more ribs 233 may include radially protruding ribs 234 to support and / or limit or prevent relative movement with another component (e.g., slide chassis 300). In some embodiments, the radially protruding ribs 234 facilitate a snug fit of components within the handle housing 230. For example, the cross-sectional view of FIG. 8 shows rib 233 and radially protruding rib portion 234 engaged with slide block partition 500 and slide chassis 300.

[0034] 8, the top surface of the slide block partition 500 engages with a rib 233 on the inside surface of the first housing portion 231 to prevent relative movement between the handle housing 230 and the slide block partition 500. The bottom of the slide chassis 300 engages with a radially protruding rib portion 234 to support and prevent relative movement of the slide chassis 300 within the handle housing 230.

[0035] 3, the first handle housing portion 231 may be coupled to the second handle housing portion 232 by known fastening means, such as threaded screws, rivets, adhesives, or other means. Accordingly, the first handle housing portion 231 and the second handle housing portion 232 may include fastening features. For example, the first handle housing portion 231 may include holes 236 that may align with corresponding holes in the second handle housing portion 232, and through which a screw may be passed to engage the second handle housing portion 232.

[0036] 4A and 4B show the upper, left, and lower structural aspects of the slide chassis 300. FIG. 8 is a cross-sectional view along the longitudinal axis of the handle assembly 200. The slide chassis 300 includes a distal end 301 and a proximal end 302. The slide chassis 300 has a length L1 and a diameter D1 sized to fit within the handle housing 230. The slide chassis 300 has a substantially cylindrical shape having a first diameter relative to the length L1 and a smaller second diameter at a step 312 at the proximal end 302.

[0037] The slide chassis 300 includes external features that engage with internal features of the handle housing 230. For example, the slide chassis 300 includes external features that engage with the inner diameter, ribs 233, and / or radial protrusions 234 of the handle housing 230. FIG. 4B illustrates a bottom surface 321 of the slide chassis 300 configured to engage with features on the inner surface of the handle housing 230. For example, the bottom surface 321 includes a flat portion having partially circular protrusions 323 spaced apart to engage one or more of the radial protrusions 234 or ribs 233 (see, e.g., FIG. 8). A bottom portion of the bottom surface 321 rests on the radial protrusions 234. As shown in FIG. 8, the lumens or hollows of the introducer, handle housing, and slide member are axially aligned with one another, including components such as the retaining nut 210, the actuation hub 450, and the connector 208.

[0038] The slide chassis 300 has a stepped cylindrical configuration (e.g., a hollow cylindrical shape including a stepped portion). The slide chassis 300 has a lumen 310 that accommodates the slide members 400L and 400R. The lumen 310 extends between a proximal end 302 and a distal end 301. The diameter of the lumen 310 varies along the length of the slide chassis 300. The diameter of the lumen 310 is at least large enough to accommodate an introducer 100 of a desired diameter (e.g., an introducer up to 15 French) and the slide members 400L, 400R. A portion of the lumen 310 has a first inner diameter and another portion of the lumen 310 has a second diameter D3 at the stepped portion 312 of the proximal end 302. The first inner diameter is larger than the second diameter D3. The first inner diameter is smaller than the diameter D1 extending from the proximal end 302 to the distal end 301. The first inner diameter is diameter D1 minus a thickness of slide chassis 300. The first inner diameter is sized to receive the distal portions of slide members 400L and 400R. The second diameter D3 is sized to receive a selected introducer. Proximal end 302 is configured in part to limit proximal translation of slide members 400L and 400R within slide chassis 300.

[0039] The slide chassis 300 includes a slide member opening 305 extending along the length of the slide chassis 300. The slide member opening 305 is configured to accommodate placement of the first slide member 400L and the second slide member 400R into the lumen 310 of the slide chassis 300. The slide member opening 305 is defined in part by a support edge 305e. The support edge 305e is configured to support the slide block divider 500. The slide member opening 305 has a length L2 extending from the stepped portion 312 toward the distal end 301.

[0040] The slide chassis 300 includes a shoulder 311 for locating the slide block divider 500 within the handle assembly 200. The shoulder 311 forms a step along the stepped cylindrical body of the slide chassis 300. The shoulder 311 extends in a plane perpendicular to the support edge 305e. The slide chassis 300 includes a flat side 313 that extends partially along the length L1 of the slide chassis 300. The inner surface of the side wall (e.g., 531 and 533 in FIG. 6A) of the slide block divider 500 contacts the flat side 313. Although the shoulder 311 and flat side 313 on one side (e.g., the left side) are shown in FIGS. 4A-4B, the same shoulder 311 and flat side 313 are also included on the other side (e.g., the right side).

[0041] 5A-5B show slide members 400L and 400R. Slide members 400L and 400R may be mirror images of each other, each having a proximal portion 441 and a distal portion 442. Distal portion 442 of first slide member 400L has an external right-hand thread 412. Distal portion 442 of second slide member 400R has an external left-hand thread 422. External right-hand thread 412 and external left-hand thread 422 engage corresponding threads 452 of actuation assembly 220 (see FIG. 2B), causing slide members 400L and 400R to slide axially in opposite directions when rotation knob 221 is rotated.

[0042] Each proximal portion 441 of the slide members 400L and 400R includes a block (e.g., a first block 413 and a second block 423) configured to secure a deflection wire (e.g., 141 and 142). The blocks 413 and 423 are diametrically larger in size than the diameter of the distal portion 442. The blocks 413 and 423 include first curved surfaces 417 and 427 that engage corresponding inner curved surfaces of the handle housing 230. The blocks 413 and 423 have a substantially rectangular shaped portion and include holes 414 and 424 for receiving from one side the deflection wires 141 and 142 that can be coupled by retaining screws 431 and 432 (see FIG. 2B) from the other side of the blocks 413 and 423. The deflection wires 141 and 142 may transmit only tensile forces. The flexible wires 141 and 142 may flex or bend within open areas 415 and 425 (e.g., notches) formed in the distal portion 442 immediately adjacent to the proximal portion 441 of each slide member 400L and 400R when the slide member 400L or 400R is displaced distally.

[0043] The first slide member 400L includes a first channel 401 and the second slide member 400R includes a second channel 411. As shown in FIG. 5B, when the slide members 400L and 400R are assembled, the channels 401 and 411 merge to form a diameter D3 configured to receive the introducer 100 while allowing the slide members 400L and 400R to slide proximally and / or distally within the slide chassis 300. The deflection wires 141 and 142 extend through the channels 401 and 411. The deflection wires 141 and 142 extend from a distal-most end of the introducer 100, through the introducer 100 and the channels 401 and 411 formed between the two slide members 400L and 400R, to near the proximal portions of the slide members. Each flexure wire may then be attached to a respective slide member 400L and 400R via a retaining screw 431 and 432, respectively.

[0044] Slide members 400L and 400R include distal sides (e.g., 416) configured to slide along either side of a portion of slide block partition 500 to inhibit rotation of the slide members within slide compartment 700. First slide member 400L includes first slide member distal end side 416 configured to slide along the first slide member side (e.g., the left side of fin portion 512 shown in FIGS. 6A and 7D ) of slide block partition 500 to inhibit rotation of first slide member 400L within slide compartment 700. Similarly, second slide member 400R includes second slide member distal end side 426 configured to slide along the second slide member side (e.g., the right side of fin portion 512 shown in FIGS. 6A and 7D ) of slide block partition 500 to inhibit rotation of second slide member 400R within slide compartment 700.

[0045] 5B and 7D, the first slide member 400L and the second slide member 400R are separated by a gap G1 through which a portion of the slide block partition (e.g., 511) extends. The slide block partition 500 has an extension 511 at a proximal end of the slide block partition 500. The extension 511 is received in the gap G1 to prevent the first deflection wire 141 from crossing the second deflection wire 142 during actuation of the introducer 100. Example structures of the slide block partition 500 are further described with respect to FIGS. 6A-6F.

[0046] 6A-6F show different views of slide block partition 500. Slide block partition 500 includes proximal end 500p and distal end 500d. Slide block partition 500 has an overall length L50 (see FIG. 6C), which may be approximately equal to length L2 of opening 305 (in FIG. 4A) of slide chassis 300. Slide block partition 500 may be made of plastic, metal, or other material and may be removably coupled (e.g., snap-fit) to slide chassis 300 over opening 305.

[0047] The slide block partition 500 includes fins 510 on an inner surface 520 that extends from the proximal end to the distal end of the slide block partition 500. The fins 510 are radially protruding portions that extend from the proximal end to the distal end of the slide block partition and are disposed between the first slide member 400L and the second slide member 400R. The fins 510 prevent the slide members 400L and 400R from rotating and prevent the first flexure wire 141 from crossing the second flexure wire 142 within the handle assembly 200.

[0048] The fin 510 of the slide block partition 500 includes a first extension 511 (having a radial length L55) at the proximal end 500p and a second fin portion 512. The radial length L55 is shorter than the radial length L54 of the second fin portion 512. The axial length of the extension 511 may be approximately the same as the axial length of the blocks 413, 423 of the slide members 400L, 400R. The axial length of the first extension 511 may be shorter than the second fin portion 512. The axial length of the second fin portion 512 may be approximately the same as the axial length of the distal portion 442 of the slide members 400L, 400R.

[0049] The slide block partition 500 includes an outer surface 541 configured to mate with the inner surface 238 of the handle housing 230. The outer surface 541 of the slide block partition 500 has a curved shape that is complementary to the inner surface 238. The outer surface 541 includes a first portion 541a, a second portion 541b, and a third portion 541c (see FIGS. 6B and 6E). The portions 541a, 541b, 541c of the outer surface 541 are spaced apart from one another via slots 551, 552. The slide block partition 500 may be an integral part manufactured as a single piece (e.g., by a molding process) or may be manufactured by fixedly joining different pieces.

[0050] Each of the slots 551, 552 is configured to receive one of the ribs 233 of the handle housing 230. As shown in FIG. 8, the slots 551, 552 engage the ribs 233 to prevent relative movement of the slide block divider 500 with respect to the handle housing 230.

[0051] The slide block partition 500 includes a pair of rails 521, 522. Each rail of the pair of rails 521, 522 extends along the length of the slide block partition 500 and is configured to rest on the slide chassis 300 (see, for example, FIG. 7D). The slide block partition 500 includes side walls 531, 533 extending along the length of the slide block partition 500. Each rail of the pair of rails 521, 522 is formed on one of the side walls 531, 533. The side walls 531, 533 have inner surfaces 532, 534, respectively. Each of the side walls 531, 533 includes a first side wall portion 531a extending from the first portion 541a, a second side wall portion 531b extending from the second portion 541b, and a third side wall portion 531c extending from the third portion 541c (see FIG. 6B).

[0052] The side walls 531, 533 of the slide block partition 500 include tail portions 536, 538 configured to abut a shoulder (e.g., 311) of the slide chassis 300 to facilitate assembly of the slide block partition 500 with the slide chassis 300. When abutted against the shoulder 311 of the slide chassis 300, the tail portions 536, 538 limit or prevent movement of the slide block partition 500 relative to the handle housing 230.

[0053] 7A shows a cutaway view of the handle assembly 200 with the slide block divider 500 removed. The rotation knob 221 is rotatably coupled to the slide chassis 300. The slide members 400L, 400R are disposed within the lumen 310 of the slide chassis 300. The rotation knob 221 is drivingly coupled to the slide members 400L, 400R via external threads of the slide members 400L, 400R and internal threads within the rotation knob 221, as described herein. The introducer 100 extends partially through a channel formed by the channels 401, 411 (shown in FIGS. 5A-5B) of the slide members 400L, 400R.

[0054] As shown in Figures 7B, 7C and 7D, the slide block divider 500 is placed over the slide chassis 300 forming the slide section 700 (Figure 7C). The inner surfaces of the side walls 531, 533 of the slide block divider 500 engage with the flat surfaces of the slide chassis 300. The rails 521, 522 rest on the support edges 305e. The extensions 511 of the fins 510 are positioned between the slide members 400L, 400R.

[0055] As the slide members 400L, 400R move axially, the extensions 511 of the fins 510 prevent the deflection wires 141, 142 from crossing one another. Movement of the slide members 400L, 400R articulates the deflection wires 141, 142, which causes the introducer 100 to deflect at the distal end 102 (FIG. 1). The slide block divider 500 constrains the slide members 400L, 400R to move linearly within the slide chassis 300. The curved inner surface of the slide block divider 500 constrains the blocks 413, 423 from floating radially (e.g., upwards in FIG. 7D).

[0056] 9 shows a cutaway view of a handle assembly 1000, which is configured similarly to handle assembly 200, except as described herein. Handle assembly 1000 includes a slide chassis 900, slide members 940L, 940R, and a pin 950 (one hidden in FIG. 9).

[0057] Figure 10A shows slide chassis 900. Figure 10B shows slide member 940L. Figure 10C shows slide member 940R. Figure 10D shows one of the pins 950. In Figures 9-10D, components included in both handle assembly 200 and handle assembly 1000 are designated with the same reference numerals.

[0058] The slide chassis 900 of the handle assembly 1000 is configured similarly to the slide chassis 300 of the handle assembly 200. The slide chassis 900 has a stepped cylindrical configuration with an opening 305 that is the same as the opening 305 of the slide chassis 300. The slide chassis 900 also includes a distal end 301 and a proximal end 302 with a stepped portion extending from the proximal end 302. In contrast to the slide chassis 300, the slide chassis 900 includes pin slots 921, 922 that extend at least partially along the length of the flat portion of the slide chassis 900. The length of the pin slots accommodates a suitable range of movement of the slide members 940L, 940R. Each of the pin slots 921, 922 is configured to receive one of the pins 950 and accommodate sliding of the pin 950 along the pin slots 921, 922.

[0059] The slide members 940L, 940R are configured similarly to the slide members 400L, 400R of the handle assembly 200. For example, the slide member 940L includes an external thread 412, and the slide member 940R includes an external thread 422. The external thread 412, 422 engage with the internal thread of the rotation knob 221 to facilitate axial movement of the slide members 940L, 940R in opposite directions. Additionally, the slide members 940L, 940R include proximal portions having blocks 413, 423. The blocks 413, 423 include pin holes 942, 952, respectively, for receiving one of the pins 950. Each of the two pins 950 extends into one of the pin holes 942, 952, such that the pins 950 are held in a fixed position and orientation relative to the respective slide members 940L, 940R.

[0060] As shown in FIG. 9, the first slide member 900L is slidably disposed within the lumen of the slide chassis 900 such that one of the pins 950 is slidably engaged within the pin slot 921. Similarly, the second slide member 900R is slidably disposed within the lumen of the slide chassis 900 such that a second pin 950 (not visible in FIG. 9) is slidably engaged within the slot 922 (shown in FIG. 10A). The pin 950 and slots 921, 922 laterally restrain the slide members 900L, 900R while allowing the slide members 900L, 900R to move longitudinally within the slide chassis 900. The pin 950 and slots 921, 922 prevent the slide members 900L, 900R from moving radially (e.g., upwardly) or displacing laterally relative to the slide chassis 900. In some embodiments, the handle assembly 1000 further includes a slide block divider 500 configurable to be disposed over the slide chassis 900. In some embodiments, the handle assembly 1000 does not include a slide block divider 500.

[0061] FIG. 11 is a cutaway view of a handle assembly 1200, which is configured similarly to the handle assemblies 200, 1000, except as described herein. The handle assembly 1200 includes slide members 400L, 400R and a slide block partition 1100. As shown in FIG. 12, the slide block partition 1100 includes an elongated profiled plate having a distal end 1100d, a proximal end 1100p, a first face surface 1101 on one side, and a second face surface 1102 on the other opposite side. The elongated profiled plate of the slide block partition 1100 is similar in shape and function to the fins 510 of the slide block partition 500 (see, e.g., FIG. 6C). The slide block partition 1100 includes a first portion 1111 and a second portion 1112 having a shape complementary to the exterior profile of the slide members 400L, 400R. The first portion 1111 has a first length L11 (see FIG. 5A) corresponding to the length of the proximal portions 441 of the slide members 400L, 400R, and a first height H11 corresponding to the distance between the inner surface 238 of the handle housing 230 and the tops of the slide members 400L, 400R. The second portion 1112 has a second length L12 corresponding to the length of the distal portions 442 of the slide members 400L, 400R (see FIG. 5A) and a second height H12 corresponding to the depth of the gap (e.g., G1 in FIG. 5B) between the slide members 400L, 400R.

[0062] In the illustrated embodiment, the second face surface 1102 includes lateral protrusions 1103, 1104, 1105, 1106 that protrude perpendicular to and from the second face surface 1102. However, the lateral protrusions 1103, 1104, 1105, 1106 may be provided on the first portion 1111 and protrude perpendicular to and from the first face surface 1101. The lateral protrusions 1103, 1104, 1105, 1106 may be sized and spaced to correspond to ribs 233 of the handle housing 230 (FIG. 3) and may engage the ribs 233 to prevent relative movement between the slide block partition 1100 and the handle housing 230.

[0063] The slide block divider 1100 is disposed between the portions of the slide members 400L, 400R. The second portion 1112 is disposed between the distal portions 442 of the slide members 400L, 400R. The second portion 1112 restrains the slide members 400L, 400R (e.g., upwardly or laterally relative to the slide chassis 300) while allowing axial movement of the slide members 400L, 400R within the slide chassis 300. A first slide member side of the slide member 400L slides along a first face surface 1101, and a second slide member side of the other slide member 400R slides along a second face surface 1102. The first portion 1111 extends between the gaps (e.g., G1 in FIG. 5B) and prevents the deflection wires 141, 142 from crossing each other while the slide members 400L, 400R slide in opposite directions within the slide chassis 300.

[0064] FIG. 13 is a schematic diagram of an introducer 100 employed in a procedure on a patient 1300. The distal end 102 of the introducer 100 is inserted into the patient 1300 (e.g., intravenously, percutaneously, or via other pathways for entering the patient's body through a body cavity 1302 of the patient 1300). The distal end 102 of the introducer 100 is advanced until it is positioned at a selected location within the patient 1300 (e.g., within the patient's heart 1306 or other organ chamber 1304, the patient's body cavity, etc.). The distal end of the introducer 100 is then deflected by rotating the adjustment knob 221 about the longitudinal axis of the handle housing 230. As can be seen from FIGS. 1-12, this causes the slide members 400L, 400R within the handle housing 230 to be displaced in opposite directions along the longitudinal axis. Each slide member 400L, 400R is coupled to a respective deflection wire 141, 142 which passes through the introducer 100 and is coupled to the distal end 102 such that the distal end 102 of the introducer 100 deflects.

[0065] The introducer 100 can be used in combination with any suitable catheter, such as a diagnostic catheter, an RF ablation catheter, an electroporation catheter, etc. Exemplary electroporation systems and catheters for electroporation systems are described in PCT Publication No. WO 2018102376A1, the entire disclosure of which is incorporated herein by reference.

[0066] FIG. 14 is a schematic and block diagram of a system 1400 for electroporation therapy using the handle assembly 200 of the introducer 100. The system 1400 may be used for irreversible electroporation to destroy tissue. In particular, the system 1400 may be used for electroporation-induced primary necrosis therapy, which refers to the effect of delivering electrical current in such a way as to directly cause irreversible loss of cell membrane (cell wall) integrity, resulting in its destruction and cell necrosis. This mechanism of cell death can be considered as an "outside-in" process, meaning that destruction of the outer wall of the cell has a deleterious effect on the interior of the cell. Typically, in classical cell membrane electroporation, electrical current is delivered as a pulsed electric field (i.e., pulsed electric field ablation (PFA)) in the form of short pulses (e.g., 0.1-20 ms duration) between closely spaced electrodes capable of delivering a field strength of approximately 0.1-1.0 kV / cm.

[0067] The handle assembly 200, 900, 1200 provides a place for the clinician to hold the introducer 100 and may also provide a means for steering or guiding the introducer shaft 110 within the body 17. For example, the handle assembly 200, 1000, 1200 may include a means for varying the length of the guidewire that extends through the introducer 100 to the distal end 102. Additionally, in some embodiments, the handle assembly 200, 1000, 1200 may be configured to change the shape, size, and / or orientation of a portion of the introducer 100. The distal end 102 of the introducer 100 may be advanced until it is positioned at a selected location within the patient body 17. The distal end 102 of the introducer shaft 110 is then deflected by rotating the adjustment knob 221 about the longitudinal axis of the handle assembly 200, 1000, 1200. 1-12, this causes the slide members 400L, 400R within the handle housing 230 to be displaced in opposite directions along the longitudinal axis. Each of the slide members 400L, 400R is coupled to a respective deflection wire 141, 142 which passes through the introducer 100 and is coupled to the distal end 102, causing the distal end 102 of the introducer 100 to deflect.

[0068] The introducer 100 can be used to introduce a catheter 1410 (e.g., a PFA catheter) into the heart (e.g., right or left atrium) to perform electroporation ablation to correct conditions such as cardiac arrhythmias. Once the introducer 100 is positioned at a selected location, the catheter 1410 may be introduced from the proximal end of the introducer 100. For example, the catheter 1410 may be inserted into the lumen of the introducer shaft 110 from the proximal end of the introducer 100 and slowly advanced through the lumen until the tip of the catheter 1410 extends beyond the distal end 102 of the introducer 100 and is positioned at the selected location. The catheter 1410 may include electrodes 12 used for various diagnostic and therapeutic purposes, including, for example, but not limited to, cardiac mapping and / or ablation (e.g., electroporation ablation). For example, in some embodiments, the electrodes may be configured as a bipolar electrode assembly for use in bipolar-based electroporation therapy. Specifically, the electrode(s) 12 are individually electrically coupleable to the generator 26 (e.g., via a suitable electrical cable 56 or other suitable electrical conductor extending through the proximal end of the catheter 1410) and are configured to be selectively energized with bipolarity (e.g., by the electroporation generator 26 and / or computer system 32) to generate an electrical potential and corresponding electric field therebetween for electroporation therapy. That is, one of the electrodes 12 is configured to function as a cathode and the other is configured to function as an anode. The electrode(s) 12 may be any suitable electroporation electrode. In an exemplary embodiment, the electrode(s) 12 are ring electrodes. The electrodes 12 may have other shapes or configurations. It is understood that the shape, size, and / or configuration of the electrode(s) 12 may affect various parameters of the applied electroporation therapy. For example, increasing the surface area of ​​one or both electrodes 12 may reduce the applied voltage required to cause the same level of tissue destruction.Although the electrode(s) 12 are described as bipolar electrodes, it should be understood that in some embodiments, the electrode(s) may be configured as monopolar electrodes and a patch electrode (e.g., return electrode 18) may be used as the return or indifferent electrode.

[0069] In some embodiments, the multiple return electrodes 18, 20, and 21, which illustrate the body connections, may be used by various subsystems included in the overall system 1400, such as an electroporation generator 26, an electrophysiology (EP) monitor such as an ECG monitor 28, or a localization and navigation system 30 for visualization, mapping, and navigation of internal body structures. In the illustrated embodiment, the return electrodes 18, 20, 21 are patch electrodes. The illustration of one patch electrode is schematic (for clarity), and it should be understood that such subsystems to which these patch electrodes are connected may, and typically will, include multiple patch (body surface) electrodes. The system 1400 may further include a main computer system 32 (including an electronic control unit 50 and a data storage memory 52), which may be integrated with the system 30 in certain embodiments. The computer system 32 may further include conventional interface components, such as various user input / output mechanisms 34a and a display 34b, among other components.

[0070] The electroporation generator 26 may be configured to energize the electrode element(s) according to an electroporation energization strategy, which may be predetermined or user selectable. The variable impedance 27 allows for varying the impedance of the system to limit arcing from the electrodes 12 of the catheter 1410. Additionally, the variable impedance 27 may be used to modify one or more characteristics of the output of the electroporation generator 26, such as the amplitude, duration, pulse shape, etc. Although illustrated as a separate component, the variable impedance 27 may be incorporated into the catheter 1410 or the generator 26. In some embodiments, each variable impedance 27 may be connected to a different catheter electrode or group of catheter electrodes such that the impedance through each catheter electrode or group of catheter electrodes can be varied separately.

[0071] 15 and 16 show pin assemblies configured to attach a deflection wire to a slide member of a handle assembly herein. In FIG. 15, the pin assemblies are coupled to slide members 400L and 400R, respectively, of a handle assembly 200 of an introducer 100 (see, e.g., FIG. 1). In the illustrated embodiment, the handle assembly 200 includes a first pin assembly 1500A and a second pin assembly 1500B for coupling a deflection wire (e.g., deflection wires 141 and 142 of FIG. 5A). Each pin assembly includes a connector shaft having a wire channel, a pin, and a spring.

[0072] For example, as shown in FIG. 16, the first pin assembly 1500A includes a first connector shaft 1501, a first pin 1503, and a first spring 1507. The first connector shaft 1501 is cylindrical, and the first pin 1503 is disposed laterally through the first connector shaft 1501. The first spring 1507 is disposed on the first connector shaft 1501 and abuts the first pin 1503 to secure the pin 1503 in place. The first connector shaft 1501 includes a wire channel 1505 that extends from a distal end 1511 to a proximal end 1512 of the first connector shaft 1501. The wire channel 1505 is configured to axially receive a flexible wire threaded through the slide member 400L. The wire channel 1505 of the first connector shaft 1501 can be aligned with the flexible wire channel (see, for example, channel 414 in FIG. 7D) of the slide member 400L. A flexible wire (eg, 141 in FIG. 5A) may be received through the wire channel 1505 and coupled to the first pin 1503 .

[0073] As shown in FIG. 15, the first pin 1503 of the first pin assembly 1500A is disposed at the proximal end of the first flexible wire channel (e.g., 414) of the first slide member 400L. The first connector shaft 1501 extends axially from the slide member 400L, while the first pin 1503 extends laterally. Similar to the first pin assembly 1500A, the second pin assembly 1500B has a second pin 1523 disposed at the proximal end of the second flexible wire channel of the second slide member 400R. A second flexible wire (e.g., 142) is coupled to the second pin 1523. The first pin 1503 and the second pin 1523 may extend toward each other to limit the vertical height available for slide block divider fins used to prevent the flexible wires from crossing each other when the slide members 400L and 400R move relative to each other. Thus, an improved slide block divider can be provided for handle assembly 200 employing pin assemblies 1500A and 1500B. An exemplary slide block divider 1700 is shown and described in detail with respect to Figures 17-20.

[0074] 17-20, the structure and assembly of slide block divider 1700 within handle assembly 200 will be described. Slide block divider 1700 has a structure similar to slide block divider 500 with fin modifications. For example, slide block divider 1700 includes a pair of rails 1721, 1722 (similar to rails 521, 522 of FIG. 6A). Each rail of the pair of rails 1721, 1722 extends along the length of slide block divider 1700 and is configured to rest on slide chassis 300 (e.g., on edge 305e, see FIG. 19). Slide block divider 1700 includes side walls 1731, 1733 (similar to walls 531, 533) extending along the length of slide block divider 1700.

[0075] The slide block partition 1700 includes a fin 1710 that extends radially toward the slide members 400L and 400R. The fin 1710 has a height L56 that extends radially downward and above the first pin 1503 and the second pin 1523 (best seen in Figures 19 and 20). Thus, the fin 1710 does not interfere with the pins 1503, 1523 during sliding of the slide members 400L, 400R. The height of the fin is approximately constant along the longitudinal axis of the slide block partition 1700 (see Figures 17 and 20). The height L56 of the fin 1710 of the slide block partition 1700 can be less than the height L55 of the extension 511 of the fin 510 of the slide block partition 500 (see Figures 18 and 6F).

[0076] It can be appreciated that the present disclosure is not limited to fins of a constant height, as the fin shape can vary along its length. For example, the fins can have a tapered shape to prevent the first pin 1503 and the second pin 1523 from contacting the fin during sliding of the slide members 400L, 400R. For example, the fin height is short at the pins 1503, 1523 and gradually increases in height along its length without interfering with the slide members.

[0077] Additionally, pins 1503 and 1523 can be modified to include a textured perimeter surface, for example to provide an improved grip between the flexible wire and the pin. For example, in FIG. 21, pin 2100 can include a first textured perimeter portion 2101. The first textured surface is sawtooth. As another example, in FIG. 22, pin 2200 can include a second textured perimeter portion 2201. The second textured surface is a diamond shaped texture.

[0078] It should be understood that the catheter 1410 and electrode configurations herein are provided by way of example and are not intended to limit the scope of the present disclosure, and that other types of catheters and / or electrodes may be employed by one of ordinary skill in the art.

[0079] In one or more embodiments of the present disclosure, the steerable introducer includes an elongate body, a first deflection wire, a second deflection wire, a handle assembly, and an actuation assembly. The elongate body includes a proximal end, a steerable portion, a first deflection lumen extending between the proximal end and the steerable portion, and a second deflection lumen extending between the proximal end and the steerable portion. The first deflection wire extends within the first deflection lumen and is operable to induce deflection of the steerable portion of the elongate body in a first direction. The second deflection wire extends within the second deflection lumen and is operable to induce deflection of the steerable portion of the elongate body in a second direction. The handle assembly is coupled to the proximal end of the elongate body. The handle assembly includes a slide chassis, a first slide member, a second slide member, and a slide block partition. The slide chassis is disposed within the handle housing. The first slide member is drivably coupled to the first deflection wire. The second slide member is drivingly coupled to the second deflection wire. A slide block partition is disposed within said handle housing. The slide block partition and slide chassis combine to form a slide compartment in which each of the first and second slide members are slidably disposed, to prevent the first and second deflection wires from crossing each other within the handle housing, and to constrain each of the first and second slide members during translation within the slide compartment to inhibit movement transverse to a longitudinal direction of the slide compartment. An actuation assembly is drivingly coupled to each of the first and second slide members. The actuation assembly is operable to simultaneously drive the first slide member distally and the second slide member proximally within the slide compartment, and is operable to simultaneously drive the first slide member proximally and the second slide member distally within the slide compartment. Optionally, the slide chassis includes a slide member opening extending along a length of the slide chassis. Optionally, the slide member opening is configured to receive installation of at least one of the first slide member and the second slide member on the slide chassis. Optionally, the slide chassis includes a support edge configured to support the slide block divider.Optionally, the slide member opening is at least partially defined by a support edge. Optionally, the slide chassis includes a shoulder for positioning the slide block partition, the shoulder extending in a plane perpendicular to the support edge at an end proximal to the distal end of the slide chassis. Optionally, the slide chassis is substantially cylindrical. Optionally, the slide block partition includes a fin extending toward the slide member to prevent the slide member from rotating and to prevent the first deflection wire from crossing the second deflection wire within the handle housing. Optionally, the fin is a radial protrusion extending from a proximal end of the slide block partition to a distal end of the slide block partition and disposed between the first and second slide members. Optionally, the handle housing includes an inner surface. The slide block partition includes an outer surface that matches the inner surface of the handle housing. Optionally, the inner surface of the handle housing has a curved shape, the curved shape having one or more ribs spaced apart from one another and extending along the curved shape. An outer surface of the slide block partition has a correspondingly curved shape with slots for receiving one or more ribs on the inner surface of the handle housing and preventing relative movement of the slide block partition with respect to the handle. Optionally, the slide block partition comprises a pair of rails, each rail of the pair of rails extending along a length of the slide block partition and configured to rest on the slide chassis. Optionally, the slide block partition comprises side walls extending along a length of the slide block partition. Each rail of the pair of rails is formed on a respective one of the side walls. Optionally, the side walls of the slide block partition include tail portions configured to abut a shoulder of the slide chassis to facilitate assembly and prevent relative movement between the slide block partition and the slide chassis. Optionally, the slide chassis comprises a flat side extending at least partially along a length of the slide chassis, an inner surface of the side wall of the slide block partition contacts the flat side. Optionally, the first slide member has an external right-hand thread. The second slide member has an external left-hand thread.The actuation assembly includes a rotatable knob having internal threads configured to engage the external right-hand and left-hand threads. Optionally, the first slide member includes a first slide member distal end side configured to slide along the first slide member side of the slide block partition to inhibit rotation of the first slide member within the slide compartment. The second slide member includes a second slide member distal end side configured to slide along the second slide member side of the slide block partition to inhibit rotation of the second slide member within the slide compartment. Optionally, the first slide member includes a first flexible wire channel through which the first flexible wire extends, and the second slide member includes a second flexible wire channel through which the second flexible wire extends. Optionally, the steerable introducer further includes a first pin assembly and a second pin assembly. The first pin assembly has a first pin disposed at a proximal end of the first flexible wire channel. The first flexible wire is coupled to the first pin. The second pin assembly has a second pin disposed at a proximal end of the second flexible wire channel. A second flexible wire is coupled to the second pin. Optionally, the slide block partition includes a fin extending radially toward the second slide member, the fin having a height that extends radially downward and above the first and second pins. Optionally, the height of the fin is constant along a longitudinal axis of the slide block partition. Optionally, the first and second slide members are separated by a gap through which a portion of the slide block partition extends. Optionally, the slide block partition has an extension at a proximal end of the slide block partition. The extension is received in the gap and prevents the first flexible wire from crossing the second flexible wire during actuation of the steerable introducer. Optionally, the fin has a tapered shape to prevent the first and second pins from contacting the fin during sliding of the slide members. Optionally, each of the first pin and the second pin includes a textured circumferential surface.

[0080] Disjunctive phrases, such as "at least one of X, Y, or Z," are intended to be understood in context as generally used to indicate that an item, term, etc., may be either X, Y, or Z, or any combination thereof (e.g., X, Y, and / or Z), unless specifically stated otherwise. Thus, such disjunctive language is generally not intended, and should not imply, that a particular embodiment requires that at least one of X, at least one of Y, or at least one of Z, respectively, be present.

[0081] Although specific embodiments have been described, these embodiments are presented for illustrative purposes only and are not intended to limit the scope of the disclosure. Indeed, the novel methods, apparatus and systems described herein may be embodied in a variety of other forms, and various omissions, substitutions and modifications of the forms of the methods, apparatus and systems described herein may be made without departing from the spirit of the disclosure. The appended claims and their equivalents are intended to cover such forms or modifications as fall within the scope and spirit of the disclosure.

Claims

1. 1. A steerable introducer comprising: an elongate body having a proximal end, a steerable portion, a first flexible lumen extending between the proximal end and the steerable portion, and a second flexible lumen extending between the proximal end and the steerable portion; a first deflection wire extending within the first deflection lumen and operable to induce deflection of the steerable portion of the elongate body in a first direction; and a second deflection wire extending within the second deflection lumen and operable to induce deflection of the steerable portion of the elongate body in a second direction; and a handle assembly coupled to the proximal end of the elongate body, the handle assembly comprising: A handle housing; a slide chassis disposed within the handle housing; a first slide member drivingly coupled to the first deflection wire; a second slide member drivingly coupled to the second deflection wire; a slide block partition disposed within the handle housing; Equipped with The slide block partition and the slide chassis are forming a slide section in which each of the first slide member and the second slide member is slidably disposed; preventing the first and second flexure wires from crossing each other within the handle housing; mating to constrain each of the first and second slide members during translation within the slide compartment to inhibit movement transverse to a longitudinal direction of the slide compartment; the handle assembly; an actuation assembly drivingly coupled to each of the first slide member and the second slide member, the actuation assembly being operable to simultaneously drive the first slide member distally and the second slide member proximally within the slide compartment, and to simultaneously drive the first slide member proximally and the second slide member distally within the slide compartment; A steerable introducer comprising:

2. the slide chassis includes a slide member opening extending along a length of the slide chassis; The steerable introducer of claim 1 , wherein the slide member opening is configured to receive installation of at least one of the first slide member and the second slide member onto the slide chassis.

3. the slide chassis includes a support edge configured to support the slide block partition; The steerable introducer of claim 2 , wherein the slide member opening is at least partially defined by the support edge.

4. 4. The steerable introducer of claim 3, wherein the slide chassis includes a shoulder for positioning the slide block partition, the shoulder extending in a plane perpendicular to the support edge at an end proximal to the distal end of the slide chassis.

5. The steerable introducer of claim 1 , wherein the slide chassis is substantially cylindrical.

6. 6. The steerable introducer of claim 1, wherein the slide block divider includes fins extending toward the slide member to prevent the slide member from rotating and to prevent the first deflection wire from crossing the second deflection wire within the handle housing.

7. 7. The steerable introducer of claim 6, wherein the fin is a radial protrusion extending from a proximal end of the slide block partition to a distal end of the slide block partition and disposed between the first slide member and the second slide member.

8. The handle housing has an inner surface; The steerable introducer of claim 1 , wherein the slide block partition includes an outer surface that mates with the inner surface of the handle housing.

9. the interior surface of the handle housing has a curved shape, the curved shape having one or more ribs spaced apart from one another and extending along the curved shape; 9. The steerable introducer of claim 8, wherein the outer surface of the slide block partition has a corresponding curved shape with slots to receive the one or more ribs on the inner surface of the handle housing and prevent relative movement of the slide block partition with respect to the handle.

10. The slide block partition includes a pair of rails; The steerable introducer of claim 1 , wherein each rail of the pair of rails extends along the length of the slide block partition and is configured to rest on the slide chassis.

11. the slide block partition includes a sidewall extending along a length of the slide block partition; The steerable introducer of claim 10 , wherein each rail of the pair of rails is formed on a respective one of the side walls.

12. 12. The steerable introducer of claim 11, wherein a side wall of the slide block partition includes a tail portion configured to abut a shoulder portion of the slide chassis to facilitate assembly and prevent relative movement between the slide block partition and the slide chassis.

13. the slide chassis includes a flat side extending at least partially along a length of the slide chassis; The steerable introducer of claim 11 , wherein an inner surface of the side wall of the slide block partition contacts the flat side.

14. the first slide member has an external right-hand thread; the second slide member has an external left-hand thread; 14. The steerable introducer of claim 1, wherein the actuation assembly comprises a rotatable knob having internal threads configured to engage the external right-handed threads and the external left-handed threads.

15. the first slide member includes a first slide member distal end side configured to slide along a first slide member side of the slide block partition to inhibit rotation of the first slide member within the slide compartment; 15. The steerable introducer of claim 1, wherein the second slide member comprises a second slide member distal end side configured to slide along the second slide member side of the slide block partition to inhibit rotation of the second slide member within the slide compartment.

16. the first slide member includes a first flexure wire channel through which the first flexure wire extends; 16. A steerable introducer as claimed in any preceding claim, wherein the second slide member includes a second flexible wire channel through which the second flexible wire extends.

17. a first pin assembly having a first pin disposed at a proximal end of the first flex wire channel, the first flex wire being coupled to the first pin; 17. The steerable introducer of claim 16, further comprising a second pin assembly having a second pin disposed at a proximal end of the second flexible wire channel, the second flexible wire being coupled to the second pin.

18. 20. The steerable introducer of claim 17, wherein the slide block partition includes a fin extending radially toward the slide member, the fin having a height that extends radially downward and above the first pin and the second pin.

19. The steerable introducer of claim 18 , wherein the fin height is constant along a longitudinal axis of the slide block partition.

20. 20. The steerable introducer of claim 16, wherein the first slide member and the second slide member are separated by a gap through which a portion of the slide block partition extends.

21. the slide block partition has an extension at a proximal end of the slide block partition; The steerable introducer of claim 20 , wherein the extension is received in the gap to prevent the first deflection wire from crossing the second deflection wire during actuation of the steerable introducer.

22. 1. A steerable introducer comprising: an elongate body having a proximal end, a steerable portion, a first flexible lumen extending between the proximal end and the steerable portion, and a second flexible lumen extending between the proximal end and the steerable portion; a first deflection wire extending within the first deflection lumen and operable to induce deflection of the steerable portion of the elongate body in a first direction; and a second deflection wire extending within the second deflection lumen and operable to induce deflection of the steerable portion of the elongate body in a second direction; and a handle assembly coupled to the proximal end of the elongate body, the handle assembly comprising: A handle housing; a slide chassis disposed within the handle housing; a first slide member having an external right-hand thread and drivingly coupled to the first flexible wire; a second slide member including an external left-handed thread and drivingly coupled to the second flexible wire; a slide block partition disposed within the handle housing; Equipped with The slide block partition and the slide chassis are forming a slide section in which each of the first slide member and the second slide member is slidably disposed; preventing the first and second flexure wires from crossing each other within the handle housing; interlocking to constrain each of the first and second slide members during translation within the slide compartment to inhibit movement transverse to a longitudinal direction of the slide compartment. the handle assembly; an actuation assembly including a rotatable knob having internal threads configured to drivingly engage the external right-handed and left-handed threads, the actuation assembly simultaneously driving the first and second slide members in opposite directions within the slide compartment; A steerable introducer comprising:

23. 23. The steerable introducer of claim 22, wherein the slide block divider comprises fins extending toward the slide member to prevent the slide member from rotating and to prevent the first deflection wire from crossing the second deflection wire within the handle housing.

24. 24. The steerable introducer of claim 23, wherein the fin is a radial protrusion extending from a proximal end of the slide block partition to a distal end of the slide block partition and disposed between the first slide member and the second slide member.

25. The handle housing has an inner surface; 25. The steerable introducer of any one of claims 22 to 24, wherein the slide block partition comprises an outer surface that mates with the inner surface of the handle housing.

26. The slide block partition includes a pair of rails; 26. The steerable introducer of any one of claims 22 to 25, wherein each rail of the pair of rails extends along the length of the slide block partition and is configured to rest on the slide chassis.

27. 1. A steerable introducer comprising: an elongate body having a proximal end, a steerable portion, a first flexible lumen extending between the proximal end and the steerable portion, and a second flexible lumen extending between the proximal end and the steerable portion; a first deflection wire extending within the first deflection lumen and operable to induce deflection of the steerable portion of the elongate body in a first direction; and a second deflection wire extending within the second deflection lumen and operable to induce deflection of the steerable portion of the elongate body in a second direction; and a handle assembly coupled to the proximal end of the elongate body, the handle assembly comprising: A handle housing; a first slide member drivingly coupled to the first deflection wire; a second slide member drivingly coupled to the second deflection wire; a slide chassis disposed within the handle housing and configured to accommodate the slide member; the handle assembly, a slide block divider disposed within the handle housing over the slide chassis, the slide block divider including fins extending toward the slide member to prevent the slide member from rotating within the handle housing and to prevent the first flexure wire from crossing the second flexure wire; an actuation assembly drivingly coupled to each of the first slide member and the second slide member; A steerable introducer comprising:

28. a first pin assembly having a first pin disposed at a proximal end of a first flex wire channel of the first slide member, the first flex wire being coupled to the first pin; 28. The steerable introducer of claim 27, further comprising a second pin assembly having a second pin disposed at a proximal end of a second flexible wire channel of the second slide member, the second flexible wire being coupled to the second pin.

29. 29. The steerable introducer of claim 27 or 28, wherein the slide block partition comprises a fin extending radially toward the slide member, the fin having a height that extends radially downward and above the first pin and the second pin.

30. 30. The steerable introducer of claim 29, wherein the fin height is constant along a longitudinal axis of the slide block partition.

31. 31. The steerable introducer of claim 29 or 30, wherein the fin has a tapered shape to prevent the first and second pins from contacting the fin during sliding of the sliding member.

32. 32. The steerable introducer of any one of claims 29 to 31, wherein the first pin and the second pin each include a textured circumferential surface.

33. the fin has an extension at a proximal end of the slide block partition; 33. The steerable introducer of any one of claims 27 to 32, wherein the extension is received in a gap between the slide members to prevent the first deflection wire from crossing the second deflection wire during actuation of the steerable introducer.

34. the slide chassis includes a slide member opening extending along a length of the slide chassis; 34. The steerable introducer of any one of claims 27 to 33, wherein the slide member opening is configured to receive installation of at least one of the first slide member and the second slide member onto the slide chassis.

35. 35. The steerable introducer of claim 27, wherein the slide chassis comprises a support edge configured to support the slide block partition and a shoulder for positioning the slide block partition, the shoulder extending in a plane perpendicular to the support edge at an end proximal to a distal end of the slide chassis.

36. 36. The steerable introducer of any one of claims 27 to 35, wherein the slide chassis is substantially cylindrical.

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