Bidirectionally steerable catheter

Abstract

The elongated sheath can include an inner sleeve, a reinforcing braid layer positioned over the inner sleeve, a pull ring positioned between the inner sleeve and the braid layer, a steering wire extending proximally from the pull ring, and an outer sleeve over the braid layer. The steering wire extends between the inner sleeve and the braid layer to an exit location distal to a proximal end of the inner sleeve and the outer sleeve. A second reinforcing braid layer can be spaced apart from the braid layer proximal to the exit location. A method of manufacturing the elongated sheath can include positioning the inner sleeve over a mandrel; positioning the pull ring over the inner sleeve, wherein the steering wire extends proximally from the pull ring; positioning the reinforcing braid layer over the inner sleeve, the pull ring, and the steering wire; positioning the outer sleeve over the braid layer; wrapping a heat shrink sleeve around the outer sleeve; and applying heat to cause reflow melting of the outer sleeve.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Patent Application No. 63 / 557,744, filed February 26, 2026, entitled “BI-DIRECTIONAL STEERABLE CATHETER,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates generally to medical devices, and more specifically to mechanisms for manipulating catheters, sheaths, and / or elongated tubular shafts. Background Technology

[0004] A variety of in vivo medical devices have been developed for medical applications, such as surgical and / or endovascular uses. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, etc.), and the like. These devices are manufactured using any of a variety of different manufacturing methods and can be used in any of these methods. Therefore, there is a continuous need for alternative medical devices and alternative methods for manufacturing and / or using these devices. Summary of the Invention

[0005] An elongated sheath for a bidirectional maneuverable catheter may include: an inner tubular sleeve having a proximal end and a distal end; a reinforcing braided layer disposed above the inner tubular sleeve and between the proximal and distal ends of the inner tubular sleeve; a distal pull ring radially disposed between the inner tubular sleeve and the reinforcing braided layer; a first maneuvering wire and a second maneuvering wire, each extending proximally from the distal pull ring; and an outer tubular sleeve covering the reinforcing braided layer, the outer tubular sleeve having a proximal end, a distal end, and a length defined by the proximal and distal ends; the first and second maneuvering wires may extend proximally from the distal pull ring between the inner tubular sleeve and the reinforcing braided layer to an outlet location distal to the proximal end of the inner tubular sleeve; the proximal end of the outer tubular sleeve may be located proximal to the outlet location.

[0006] Except for or alternative to any of the examples disclosed herein, the distal end of the reinforcing braid is proximally spaced from the distal end of the outer tubular sleeve, and the proximal end of the reinforcing braid is positioned distally at the outlet location.

[0007] Except for any examples disclosed herein or as an alternative, the first and second control cables are fixedly attached to the distal pull ring.

[0008] In addition to or as an alternative to any of the examples disclosed herein, the elongated sheath may include a first control cable tube and a second control cable tube, each extending from the distal pull ring toward the proximal end of the outlet position, the first control cable and the second control cable being slidably disposed within the first control cable tube and the second control cable tube, respectively.

[0009] In addition to or as an alternative to any of the examples disclosed herein, an elongated sheath may include a distal marking strip disposed distal to the distal end of the reinforcing braided layer and proximal to the distal end of the outer tubular sleeve.

[0010] In addition to or as an alternative to any of the examples disclosed herein, the elongated sheath may include a proximal marking band that is proximally spaced from the distal marking band and distally spaced from the distal pull loop.

[0011] In addition to or as an alternative to any of the examples disclosed herein, an elongated sheath for a bidirectional steerable catheter may include: an inner tubular sleeve having a proximal end and a distal end; a reinforcing braided layer disposed over the inner tubular sleeve and between the proximal and distal ends of the inner tubular sleeve; a distal pull loop radially disposed between the inner tubular sleeve and the reinforcing braided layer; a first and a second steerable wire, each extending proximally from the distal pull loop; and an outer tubular sleeve covering the reinforcing braided layer, the outer tubular sleeve having a proximal end, a distal end, and a length defined by the proximal and distal ends; the first and second steerable wires may extend proximally from the distal pull loop between the inner tubular sleeve and the reinforcing braided layer to an outlet location distal to the proximal end of the inner tubular sleeve; the proximal end of the outer tubular sleeve may be located proximal to the outlet location. The elongated sheath may include a second reinforcing braided layer spaced apart from the reinforcing braided layer. The second reinforcing braided layer can be disposed above the inner tubular sleeve, near the outlet position, and covered by the outer tubular sleeve.

[0012] Except for or alternative to any examples disclosed herein, the first and second control wires are disposed radially outside the outer tubular sleeve, near the outlet position.

[0013] In addition to or as an alternative to any of the examples disclosed herein, in the normal construction of a slender sheath, a pre-defined double bend is provided between the proximal end of the reinforcing braid and the distal end of the reinforcing braid.

[0014] Except for or as an alternative to any examples disclosed herein, the outer tubular sleeve is formed from multiple individual segments of polymer material.

[0015] Apart from or as an alternative to any example disclosed herein, at least three of the multiple individual segments each have different hardness and alternate longitudinally along the length of the outer tubular sleeve.

[0016] In addition to or as an alternative to any of the examples disclosed herein, a method of manufacturing an elongated sheath for a bidirectional steerable catheter may include: positioning an inner tubular sleeve on a mandrel; positioning a distal loop over the inner tubular sleeve, proximal to the distal end of the inner tubular sleeve, wherein a first steerable wire and a second steerable wire each extend proximally from the distal loop; positioning a reinforcing braid over the inner tubular sleeve, the distal loop, the first steerable wire, and the second steerable wire; positioning an outer tubular sleeve over the reinforcing braid; surrounding the outer tubular sleeve with a heat-shrink sleeve; and applying heat to cause the outer tubular sleeve to reflow and melt around the reinforcing braid and the inner tubular sleeve.

[0017] In addition to or as an alternative to any example disclosed herein, positioning the reinforcing braid further includes: positioning a distal tubular braid fastener over the reinforcing braid and near its distal end; positioning a distal heat shrink sleeve over the distal tubular braid fastener; and applying heat to cause the distal tubular braid fastener to reflow and melt around the reinforcing braid at its distal end near the reinforcing braid.

[0018] In addition to or as an alternative to any example disclosed herein, positioning the reinforcing braid further includes, after applying heat to cause the distal tubular braid fastener to reflow and melt: positioning the proximal tubular braid fastener above the reinforcing braid and near the proximal end of the reinforcing braid; positioning the proximal heat shrink sleeve above the proximal tubular braid fastener; and applying heat to cause the proximal tubular braid fastener to reflow and melt around the reinforcing braid at the proximal end of the reinforcing braid.

[0019] In addition to or as an alternative to any of the examples disclosed herein, the positioning of the outer tubular sleeve further includes positioning multiple individual segments of polymer material over the reinforcing braided layer.

[0020] Apart from or as an alternative to any example disclosed herein, at least three of the multiple individual segments each have different hardness and alternate longitudinally along the length of the outer tubular sleeve.

[0021] In addition to or as an alternative to any of the examples disclosed herein, positioning the outer tubular sleeve further includes positioning a proximal handle segment of polymer material above the inner tubular sleeve, proximal to the reinforcing braid layer.

[0022] In addition to or as an alternative to any of the examples disclosed herein, positioning the outer tubular sleeve further includes positioning the second reinforcing braid layer over the inner tubular sleeve, proximal to the reinforcing braid layer; and then positioning the proximal handle portion of the polymer material over the second reinforcing braid layer.

[0023] In addition to or as an alternative to any of the examples disclosed herein, the proximal handle section of the polymer material includes a second reinforcing braided layer embedded therein.

[0024] In addition to or as an alternative to any of the examples disclosed herein, the method may include securingly attaching the hub member to the proximal end of the outer tubular sleeve.

[0025] Except for any examples disclosed herein or as an alternative, the proximal handle section is integrally formed with the hub member disposed at its proximal end.

[0026] Except for or alternative to any examples disclosed herein, the proximal portions of the first control cable and the second control cable are disposed radially outside the proximal handle section of the polymer material.

[0027] The above summary of some embodiments, aspects, and / or examples is not intended to describe every embodiment or every implementation of this disclosure. The accompanying drawings and detailed description illustrate various aspects of these embodiments in more specific terms. Attached Figure Description

[0028] This disclosure will be more fully understood in light of the following detailed description taken in conjunction with the accompanying drawings, in which:

[0029] Figure 1 Selected aspects of an exemplary steerable catheter are shown;

[0030] Figure 2 It shows Figure 1 Selected aspects of an exemplary tunable catheter;

[0031] Figure 3 It shows Figure 1 Selected aspects of an exemplary tunable catheter;

[0032] Figure 4 It shows Figure 1 Selected aspects of an exemplary tunable catheter;

[0033] Figure 4A yes Figure 4 A cross-sectional view taken along line 4A-4A;

[0034] Figure 5 Maneuvering in the first direction is shown Figure 1 Selected aspects of an exemplary tunable catheter;

[0035] Figure 6 Demonstrates second-directional manipulation Figure 1 Selected aspects of an exemplary tunable catheter;

[0036] Figures 7-12 Selected aspects of the slender sheath of the manipulable catheter and methods for manufacturing the slender sheath are shown;

[0037] Figure 13 Selected aspects of alternative constructions for the elongated sheath of a steerable catheter are shown, along with methods for manufacturing the elongated sheath; and

[0038] Figure 14 Selected aspects of alternative constructions for the slender sheath of a manipulable catheter and methods for manufacturing the slender sheath are shown.

[0039] While various modifications and alternatives may be made to the various aspects of this disclosure, its details have been illustrated by example in the accompanying drawings and will be described in detail. However, it should be understood that the purpose is not to limit the various aspects of this disclosure to the specific embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0040] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, wherein similar reference numerals indicate similar elements throughout multiple views. The detailed description and drawings are intended to illustrate, not limit, this disclosure. Those skilled in the art will recognize that the various elements described and / or shown can be arranged in various combinations and configurations without departing from the scope of this disclosure. The detailed description and drawings illustrate exemplary embodiments of this disclosure.

[0041] The terms defined below shall apply unless otherwise defined in the claims or elsewhere in this specification.

[0042] All numerical values ​​assumed herein are modified by the term "approximately," whether explicitly stated or not. In the context of numerical values, the term "approximately" generally refers to a range of numerical values ​​that a person skilled in the art would consider equivalent to the stated value (e.g., having the same function or result). In many cases, the term "approximately" may include numerical values ​​rounded to the nearest significant figure. Unless otherwise specified, other uses of the term "approximately" (e.g., in contexts other than numerical values) may be assumed to have their common and customary definition, as understood from and consistent with the context of the specification.

[0043] A description of a range of values ​​by endpoints includes all values ​​in that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0044] Although some appropriate dimensions, ranges and / or values ​​related to various components, features and / or specifications are disclosed, those skilled in the art inspired by this disclosure will understand that expected dimensions, ranges and / or values ​​may deviate from those explicitly disclosed dimensions, ranges and / or values.

[0045] As used in this specification and the appended claims, the singular forms “a (a, an)” and “the” include plural indicators unless expressly stated otherwise. As used in this specification and the appended claims, the term “or” is generally used to mean “and / or” unless expressly stated otherwise. It should be noted that, for ease of understanding, certain features of this disclosure may be described in the singular, even if such features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or be contained in a single disclosure unless expressly stated otherwise. For example, unless expressly stated otherwise, a reference to a particular technical feature may equally refer to all embodiments of that technical feature and all instances where the number is greater than one. Therefore, it should be understood that the following discussion may equally apply to any and / or all components having multiple parts, unless expressly stated otherwise.

[0046] For example, related terms such as “proximal,” “distal,” “advance,” “retreat,” and their variations are generally considered relative to the positioning, orientation, and / or operation of various elements of the device relative to the user / operator / manipulator, where “proximal” and “retreat” indicate or refer to being closer to or towards the user, while “distal” and “advance” indicate or refer to being further away from or away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily designated to aid in understanding this disclosure, and these cases are clear to those skilled in the art. Other related terms, such as “upstream,” “downstream,” “inflow,” and “outflow,” refer to the direction of fluid flow within a lumen (such as a body lumen, blood vessel, or device). Other related terms, such as “axial,” “circumferential,” “longitudinal,” “transverse,” “radial,” and / or their variations, generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0047] The term "range" can be understood as representing the maximum measured value of the said or identified dimension, unless the range or dimension is previously or identified as a "minimum," in which case it can be understood as representing the minimum measured value of the said or identified dimension. For example, "outer range" can be understood as an outer dimension, "radial range" as a radial dimension, "longitudinal range" as a longitudinal dimension, and so on. Each instance of "range" can be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be clear to those skilled in the art from the context of its individual use. Generally, "range" can be considered as the maximum possible dimension measured according to its intended use, while "minimum range" can be considered as the minimum possible dimension measured according to its intended use. In some cases, "range" can typically be measured orthogonally within a plane and / or cross-section, but can be clearly seen from the specific context to be measured in different ways, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc.

[0048] The terms “monolithic” and “single” generally refer to one or more elements made or composed of a single structural or basic unit / element. Monolithic elements and / or single elements should exclude structures and / or features formed by assembling or otherwise joining together multiple discrete structures or elements.

[0049] It should be noted that references to "embodiments," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include specific features, structures, or characteristics, but each embodiment does not necessarily include those specific features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiment. Moreover, when a specific feature, structure, or characteristic is described in connection with an embodiment, unless the contrary is explicitly stated, those skilled in the art will, to the best of their knowledge, implement that specific feature, structure, or characteristic in conjunction with other embodiments, whether explicitly described or not. That is, the various individual elements described below, even if not explicitly shown in a specific combination, are still considered to be combinable or arrangeable to form other additional embodiments, or to supplement and / or enrich the described embodiments, as understood by those skilled in the art.

[0050] For clarity, certain identifying numerical designations (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish features of various descriptions and / or claims. It should be understood that the numerical designations are not restrictive but merely exemplary. In some embodiments, for brevity and clarity, previously used numerical designations may be modified and deviated from. That is, a feature identified as a “first” element may later be referred to as a “second” element, a “third” element, etc., or may be omitted entirely, and / or different features may be referred to as a “first” element. The meaning and / or name in each case are clear to a skilled practitioner.

[0051] In some medical procedures, delivery and / or entry sheaths can be percutaneously inserted into body cavities, lumens, and / or treatment sites. Guidance through the patient's vascular system and / or organs may include manipulating through tortuous anatomical structures and / or guiding the distal end of the delivery and / or entry sheath into the body cavity, lumen, and / or treatment site. This document describes examples of medical devices suitable for use in medical procedures such as, but not limited to, left atrial appendage closure, aortic valve replacement, mitral valve replacement, and septal defect repair. Existing medical devices may have certain advantages and / or disadvantages. There is a continuing need for alternative manipulable medical devices for delivering medical implants and / or performing other therapeutic procedures.

[0052] Figure 1 Selected aspects of the bidirectional tactile catheter 100 are shown. In some embodiments, the bidirectional tactile catheter 100 can be any of a variety of catheters, such as an intravascular catheter. Examples of intravascular catheters may include, but are not limited to, balloon catheters, rotary cutting catheters, device delivery catheters, drug delivery catheters, diagnostic catheters, and guiding catheters. In some embodiments, the bidirectional tactile catheter 100 may take the form of other suitable guiding, diagnostic, or therapeutic devices (including endoscopic instruments, laparoscopic instruments, etc.) and may be suitable for use at different locations and / or lumens within the patient's body.

[0053] The bidirectional steerable catheter 100 may include a handle 110 and an elongated sheath 140 extending distally from the handle 110. In some embodiments, the bidirectional steerable catheter 100 and / or the handle 110 may include a guidewire port, a side port, a fluid flushing port, an imaging access port, or other suitable port, access point, or functional feature. The handle 110 may include a handle housing 112. The elongated sheath 140 may extend into and / or through a distal opening in the handle housing 112. In at least some embodiments, a proximal end of the elongated sheath 140 may be securely attached to and / or disposed within the handle housing 112. In some embodiments, the proximal portion of the elongated sheath 140 may include a bonding element configured to non-rotatably engage one or more locking elements securedly attached to an inner surface of the handle housing 112, proximal to the distal end of the handle housing 112. In some embodiments, the bonding element may be bonded to an outer surface of the elongated sheath 140. In some embodiments, the bonding element may be integrally formed with the elongated sheath 140. In some embodiments, the bonding element may be welded (e.g., thermal welding, sonic welding, vibration welding, etc.) to the elongated sheath 140. In some embodiments, the bonding element may be fused (e.g., reflowed) together with the elongated sheath 140 such that the material of the bonding element is co-mixed with the material of the elongated sheath 140 at the molecular level. In some embodiments, the handle housing 112 may include one or more locking elements fixedly attached to and / or integrally formed with the inner surface of the handle housing 112. In some embodiments, one or more locking elements may be formed as ribs or other structural support members configured to increase the rigidity of the handle housing and allow torque transmission between the distal end of the handle housing 112 and the elongated sheath 140. In some embodiments, the elongated sheath 140 may have a normal or relaxed configuration. The elongated sheath 140 may be self-biased toward the normal or relaxed configuration and / or may return to the normal or relaxed configuration without any external force. Suitable, but non-limiting, materials for the handle 110 and / or handle housing 112 are described below.

[0054] In some embodiments, the elongated sheath 140 may include a soft and / or damage-resistant distal end 142. In some embodiments, the elongated sheath 140 may include a distal portion 144 having a first bend 146 and a second bend 148, such that the elongated sheath 140 has a pre-defined double bend in a normal or relaxed configuration. In some embodiments, the first bend 146 may be pre-defined to bend upward when viewed from the side. Other configurations are also contemplated. In some embodiments, the second bend 148 may be pre-defined to bend to the left when viewed along the elongated sheath 140 from proximal to distal. Other configurations are also contemplated. In some embodiments, the distal portion 144 and / or the first bend 146 may be configured to bend or deflect in a first direction, wherein the soft and / or damage-resistant distal end 142 bends and / or moves toward and / or closer to the handle 110 to toward and / or reach a deflection configuration, such as... Figure 1 As shown. In some embodiments, the distal portion 144 and / or the first bend 146 may be configured to bend or deflect in a second direction opposite to the first direction, wherein the soft and / or damage-resistant distal end 142 is bent and / or moved away from and / or further away from the handle 110 to toward and / or reach a straightened configuration, such as Figure 1 As shown by the dashed lines. In some embodiments, the elongated sheath 140 may have only a single bend in a normal or relaxed configuration. In some embodiments, the elongated sheath 140 may be substantially straight in a normal or relaxed configuration. Other configurations, including combinations of those described herein, are also contemplated.

[0055] Figure 2 and Figure 3Selected features of the bidirectional steerable conduit 100 are shown. In the view shown, a portion of the handle housing 112 has been removed to reveal some internal components of the handle 110. In some embodiments, the handle 110 may include an axial translation mechanism 120. In some embodiments, the axial translation mechanism 120 may include a threaded member 122 slidably disposed within the handle 110 and / or handle housing 112. In some embodiments, the axial translation mechanism 120 may include a rotatable knob 124. In some embodiments, the rotatable knob 124 may be configured to rotate about at least a portion of the handle housing 112 and / or the handle 110 and / or relative to at least a portion of the handle housing 112 and / or the handle 110. In some embodiments, the rotatable knob 124 may be configured to engage the threaded member 122 such that rotation of the rotatable knob 124 relative to the handle 110 and / or the handle housing 112 causes the threaded member 122 to be axially translated proximally and / or distally within the handle 110 and / or the handle housing 112. In some embodiments, when viewed proximally to distally along the bidirectional steerable conduit 100, rotation of the rotatable knob 124 in a clockwise direction causes axial translation of the threaded member 122 distally within the handle 110 and / or handle housing 112. In some embodiments, when viewed proximally to distally along the bidirectional steerable conduit 100, rotation of the rotatable knob 124 in a counterclockwise direction causes axial translation of the threaded member 122 proximally within the handle 110 and / or handle housing 112. In some embodiments, reverse and / or opposite configurations may be used, wherein clockwise rotation of the rotatable knob 124 moves the threaded member 122 proximally, and counterclockwise rotation of the rotatable knob 124 moves the threaded member 122 distally. The orientation of the internal and external threads on the threaded member 122 and the rotatable knob 124 respectively determines which direction of rotation is associated with which direction of axial translation. The following describes some suitable, but not limiting, materials for the axial translation mechanism 120, the threaded member 122, and / or the rotatable knob 124.

[0056] The first control cable 130 can extend from the handle 110 and / or handle housing 112 through an elongated sheath 140 to the distal pull ring 150 (e.g.) Figure 4 The second control cable 132 can extend from the handle 110 and / or handle housing 112 through an elongated sheath 140 to the distal pull ring 150 (e.g., Figure 4The second control wire 132 may be positioned relative to the central longitudinal axis of the elongated sheath 140 on the side of the elongated sheath 140 opposite to the first control wire 130. As described herein, tension may be applied to the first control wire 130 and / or the second control wire 132 to bend and / or deflect the distal portion 144 and / or the first bend 146 of the elongated sheath 140 (e.g., Figure 1 The first operating line 130 may be configured to engage the axial translation mechanism 120 and / or the threaded member 122 to bend and / or deflect the distal portion 144 and / or the first bend 146 of the elongated sheath 140 toward the handle 110 and / or the handle housing 112 in a first direction, toward and / or to reach the deflection configuration (e.g., Figure 1 The second operating line 132 can be configured to engage the axial translation mechanism 120 and / or the threaded member 122 to bend and / or deflect the distal portion 144 and / or the first bend 146 of the elongated sheath 140 away from the handle 110 and / or the handle housing 112 in a second direction opposite to the first direction, toward and / or to reach the straightened configuration (e.g., Figure 1 ).

[0057] In some embodiments, the bidirectional steerable conduit 100 may include a pulley 160 disposed within a handle 110 and / or handle housing 112. The pulley 160 may engage a first actuation cable 130 via a circumferential channel extending around the pulley 160. In some embodiments, the pulley 160 may engage the first actuation cable 130 at a location near the distal end of the threaded member 122. In some embodiments, the pulley 160 may engage the first actuation cable 130 at a location proximal to the distal end of the threaded member 122. In some embodiments, the bidirectional steerable conduit 100 may include a tensioning member 170. The tensioning member 170 may connect a first end (e.g., a proximal end) of the first actuation cable 130 to the handle 110 and / or handle housing 112. In at least some embodiments, the proximal end of the first actuation cable 130 may be securely connected to the handle 110 and / or handle housing 112 via the tensioning member 170. In some embodiments, the pulley 160 may engage the first actuation cable 130 at a location proximal to the tensioning member 170. In some embodiments, the tensioning member 170 may be coupled to the handle 110 and / or the handle housing 112 at a location distal to the proximal end of the first operating cable 130. In some embodiments, the tensioning member 170 may be an elastic polymer, such as... Figure 2 As shown. In another example, the tensioning member 170 can be a helical spring, such as... Figure 3As shown. Other configurations may also be considered. Clearly, when the distal portion 144 of the elongated sheath 140 and / or the first bend 146 is in a normal or relaxed configuration, and / or when the distal portion 144 of the elongated sheath 140 and / or the first bend 146 is bent and / or deflected and / or reaches the straightened configuration in a second direction, the tensioning member 170 can be configured to apply a small, non-biased amount of tension to the first actuating wire 130. The purpose of the tensioning member 170 is to prevent the first actuating wire 130 from disengaging from the pulley 160 by keeping the first actuating wire 130 taut around the pulley 160 when no tension is applied to the first actuating wire 130 via the axial translation mechanism 120 and / or the threaded member 122 (e.g., in a normal or relaxed configuration, or toward and / or in a straightened configuration). Some suitable, but non-limiting, materials for the pulley 160 and / or tensioning member 170 are described below.

[0058] Additionally or alternatively, in some embodiments, the bidirectional steerable conduit 100 may include one or more ribs, protrusions, bosses, or supports extending laterally within the handle housing 112 between opposing walls and / or opposing sides of the handle housing 112. In some embodiments, one or more ribs, protrusions, bosses, or supports may be disposed within the handle housing 112, their positions configured to approximate the diameter and / or circumference of the pulley 160. In some embodiments, one or more ribs, protrusions, bosses, or supports may replace the pulley 160. In some embodiments, one or more ribs, protrusions, bosses, or supports may be provided in addition to the pulley 160. In some embodiments, one or more ribs, protrusions, bosses, or supports may extend completely from one side of the handle housing 112 across the interior of the handle housing 112 to the opposite side of the handle housing 112. In some embodiments, the first control cable 130 can be positioned around and / or slide over one or more ribs, protrusions, bosses or pillars in a manner similar to the first control cable 130 extending around the pulley 160, such that one or more ribs, protrusions, bosses or pillars can serve as guides for the first control cable 130 and prevent motion loss.

[0059] The threaded member 122 may include a first engagement portion 126 extending laterally from the threaded member 122 in a first lateral direction. A first operating cable 130 may extend and / or pass through the first engagement portion 126. The first operating cable 130 may include a first stop element 134 configured to engage with the first engagement portion 126 and / or the axial translation mechanism 120 of the threaded member 122 when the threaded member 122 slides in a distal direction within the handle 110 and / or the handle housing 112 to apply tension to the first operating cable 130. Figure 2As shown. The tension applied by the axial translation mechanism 120 and / or the threaded member 122 is sufficient to overcome the self-biasing of the elongated sheath 140 toward the normal or relaxed configuration, and to bend and / or deflect the distal portion 144 and / or the first bend 146 of the elongated sheath 140 in the first direction.

[0060] The threaded member 122 may include a second engagement portion 128 extending laterally from the threaded member 122 in a second lateral direction opposite to the first lateral direction. A second operating cable 132 may extend and / or pass through the second engagement portion 128. The second operating cable 132 may include a second stop element 136 configured to engage with the second engagement portion 128 of the threaded member 122 and / or the axial translation mechanism 120 when the threaded member 122 slides in a proximal direction within the handle 110 and / or handle housing 112 to apply tension to the second operating cable 132. Figure 3 As shown. The tension applied by the axial translation mechanism 120 and / or the threaded member 122 is sufficient to overcome the self-biasing of the elongated sheath 140 toward the normal or relaxed configuration, and to bend and / or deflect the distal portion 144 and / or the first bend 146 of the elongated sheath 140 in the second direction.

[0061] Depending on the direction of movement of the threaded member 122, the pulley 160 allows the threaded member 122 to apply tension to the first operating cable 130 and the second operating cable 132. The tension applied to the first operating cable 130 and the second operating cable 132 causes the distal portion 144 and / or the first bend 146 of the elongated sheath 140 to bend and / or deflect away from the normal or relaxed configuration. Since both operating cables extend proximally from the distal pull ring 150, the pulley 160 needs to reverse the orientation of the first operating cable 130 relative to the second operating cable 132 within the handle 110 and / or handle housing 112, so that the threaded member 122 can selectively apply tension to the first operating cable 130 and the second operating cable 132 by moving in opposite directions. In one or more alternative configurations, the handle 110 and / or handle housing 112 may include internal ribs, internal protrusions, or other features disposed therein in place of the pulley 160, around which the first actuation cable 130 may extend and reverse direction to function as described herein.

[0062] When the threaded member 122 is positioned in the center, the distal portion 144 and / or the first bend 146 of the elongated sheath 140 can be positioned in a normal or relaxed configuration. When the threaded member 122 is positioned in the center, substantially no tension is applied to the first operating cable 130 and / or the second operating cable 132. When the threaded member 122 is axially translated proximally and / or distally within the handle 110 and / or handle housing 112, the threaded member 122 of the axial translation mechanism 120 can engage with the first operating cable 130 and / or the second operating cable 132 to apply tension thereto, thereby bending and / or deflecting the distal portion 144 and / or the first bend 146 of the elongated sheath 140, as described herein. Furthermore, when the threaded member 122 is in the center position, the first engaging portion 126 can engage with the first stop element 134, but no tension is applied to the first operating wire 130, and the second engaging portion 128 can engage with the second stop element 136, but no tension is applied to the second operating wire 132. Therefore, the center position of the threaded member 122 can be tension-neutral relative to the first operating wire 130 and the second operating wire 132.

[0063] As the threaded member 122 moves from the central position toward the proximal position and / or until it is positioned at that proximal position, tension can be applied to the second operating cable 132, and the distal portion 144 of the elongated sheath 140 and / or the first bend 146 can be bent and / or deflected away from the handle 110 and / or handle housing 112 in a second direction, or toward and / or to a straightened configuration. When the threaded member 122 is moved proximal within the handle 110 and / or handle housing 112 from the central position, the second engagement portion 128 engages the second stop element 136, and thereafter translates the second stop element 136 proximal, thereby applying tension to the second operating cable 132, such as... Figure 3As shown. When the threaded member 122 slides proximally within the handle 110 and / or handle housing 112, the first stop element 134 can disengage from the axial translation mechanism 120, the threaded member 122, and / or the first engagement portion 126 to release tension on the first operating cable 130. Therefore, as the threaded member 122 moves proximally from its central position, the first engagement portion 126 can disengage from the first stop element 134, and the first engagement portion 126 can slide proximally along and / or over the first operating cable 130. When the threaded member 122 slides proximally within the handle 110 and / or handle housing 112, the first stop element 134 can be configured to float relative to the axial translation mechanism 120, the threaded member 122, and / or the first engagement portion 126 (e.g., the first stop element 134 may not be directly fixed to the aforementioned components). Therefore, a slack will be formed in the first operating cable 130, which will allow the first operating cable 130 to disengage from the pulley 160 if no tension is applied by the tensioning member 170. When no tension is applied to the first operating cable 130 through the threaded member 122 and / or the first engagement portion 126, the tensioning member 170 keeps the first operating cable 130 tightly attached to the pulley 160. The tensioning member 170 only absorbs any slack formed in the first operating cable 130 due to the disengagement of the first engagement portion 126 from the first stop element 134, and prevents the first operating cable 130 from disengaging from the pulley 160. For example, in Figure 3 This feature can be seen in the structure shown.

[0064] As the threaded member 122 moves from the central position toward the distal position and / or until it is positioned at that distal position, tension can be applied to the first operating cable 130, and the distal portion 144 of the elongated sheath 140 and / or the first bend 146 can be bent and / or deflected toward the handle 110 and / or the handle housing 112 in a first direction, or toward and / or to a deflection configuration. When the threaded member 122 is moved distally within the handle 110 and / or the handle housing 112, the first engagement portion 126 engages the first stop element 134, and thereafter translates the first stop element 134 distally, thereby applying tension to the first operating cable 130, such as... Figure 2As shown. When the threaded member 122 slides in the distal direction within the handle 110 and / or handle housing 112, the second stop element 136 can disengage from the axial translation mechanism 120, the threaded member 122, and / or the second engagement portion 128 to release tension on the second operating cable 132. Therefore, when the threaded member 122 moves distally from its central position, the second engagement portion 128 can disengage from the second stop element 136 and can slide distally along and / or over the second operating cable 132. When the threaded member 122 slides in the distal direction within the handle 110 and / or handle housing 112, the second stop element 136 can be configured to float relative to the axial translation mechanism 120, the threaded member 122, and / or the second engagement portion 128 (e.g., the second stop element 136 may not be directly fixed to the aforementioned components). Therefore, as the second engaging portion 128 disengages from the second stopping element 136, a slack is formed in the second operating wire 132. Figure 2 As can be seen in the configuration shown, when the threaded member 122 translates from the proximal position and / or the central position to the distal position, the first engagement portion 126 engages the first stop element 134, and the first operating wire 130 is subsequently pulled around the pulley 160, and the tension applied by the tensioning member 170 is released, the tension instead being applied to the first operating wire 130 by the first engagement portion 126 and / or the threaded member 122.

[0065] Figure 4 and Figure 4ASelected aspects of an exemplary construction of an elongated sheath 140 are shown, at least some of which are described above. In some embodiments, the elongated sheath 140 may include a wall 141 defining a central lumen 143 extending along a central longitudinal axis of the elongated sheath 140 from a proximal end to a soft and / or damage-resistant distal end 142. In at least some embodiments, the central lumen 143 may be coaxial with the central longitudinal axis of the elongated sheath 140. In some embodiments, the central lumen 143 may be a guidewire lumen. In some embodiments, the central lumen 143 may be a device lumen for delivering a medical device or implant. In some embodiments, the central lumen 143 may have multiple uses. The elongated sheath 140 may include a plurality of manipulator lumens 145 extending within and / or disposed within the wall 141. In some embodiments, the plurality of manipulator lumens 145 may include a first manipulator lumen and a second manipulator lumen. In some embodiments, the plurality of manipulator lumens 145 may include more than two manipulator lumens. In some embodiments, the plurality of control wire lumens 145 may be oriented substantially parallel to the central longitudinal axis of the central lumen 143 and / or the elongated sheath 140. In some embodiments, the plurality of control wire lumens 145 may be disposed opposite to each other and / or disposed on opposite sides of the elongated sheath 140 relative to the central longitudinal axis of the central lumen 143 and / or the elongated sheath 140. Other configurations are also contemplated.

[0066] In some embodiments, the plurality of control wire lumens 145 may have a circular cross-sectional shape, such as Figure 4 As shown. However, Figure 4 The cross-sectional shapes shown are merely exemplary and not intended to be limiting. In some embodiments, the plurality of control wire lumens 145 may have other cross-sectional shapes. For example, in some embodiments, the plurality of control wire lumens 145 may have a rectangular cross-sectional shape, an oval cross-sectional shape, a square cross-sectional shape, or a polygonal cross-sectional shape, etc. In some embodiments, the plurality of control wire lumens 145 may have irregular and / or asymmetrical cross-sectional shapes. Other configurations may also be considered.

[0067] As described herein, the distal pull ring 150 may be disposed within the distal portion 144 of the elongated sheath 140. In some embodiments, the distal pull ring 150 may be disposed proximal to the second bend 148 and / or the soft and / or damage-resistant distal end 142. In at least some embodiments, the distal pull ring 150 may be disposed near the distal end of the first bend 146. In some embodiments, the distal pull ring 150 may be embedded within the wall 141 of the elongated sheath 140. In some embodiments, the distal pull ring 150 may be fixedly, adhesively, and / or securely attached to the inner surface of the wall 141 of the elongated sheath 140. Other configurations are also contemplated. Some suitable, but non-limiting, materials for the distal pull ring 150 are described below.

[0068] The first control wire 130 and the second control wire 132 may each be slidably disposed within a plurality of control wire lumens 145. In one example, the first control wire 130 may be slidably disposed within a first control wire lumen, and the second control wire 132 may be disposed within a second control wire lumen. The first control wire 130 and the second control wire 132 may be fixedly attached (e.g., glued, welded, etc.) to a distal pull ring 150. For example, the distal end of the first control wire 130 may be fixedly attached to the distal pull ring 150, and the distal end of the second control wire 132 may be fixedly attached to the distal pull ring 150 at a position opposite to the distal end of the first control wire 130 relative to the central longitudinal axis of the elongated sheath 140. Some suitable, but non-limiting, materials for the first control wire 130 and the second control wire 132 are described below.

[0069] In some embodiments, the dimensions of the elongated sheath 140 can be determined according to its intended use. For example, the length of the elongated sheath 140 can range from about 50 to about 200 cm, from about 75 to about 175 cm, or from about 100 to about 150 cm. Other lengths are also contemplated. It is also conceivable that the outer diameter of the elongated sheath 140 can vary depending on its use or application. In some examples, the outer diameter of the elongated sheath 140 can be about 2 mm, about 3 mm (or 9 French), about 3.5 mm, about 4 mm (or 12 French), about 4.5 mm, about 5 mm (or 15 French), about 5.33 mm, about 5.5 mm, about 5.66 mm (or 17 French), about 6 mm, about 6.5 mm, about 7 mm (or 21 French), about 8 mm, or other suitable dimensions. In some embodiments, the outer diameter of the elongated sheath 140 can be a maximum of 5.66 mm (17 French), and is preferably less than 5.66 mm (17 French). Other configurations are also contemplated. The following discusses additional aspects, structural details, and / or methods or steps related to the making and / or manufacture of the slender sheath 140. Some suitable, but not limiting, materials for the slender sheath 140 are described below.

[0070] Figure 5 and Figure 6 The relationship between certain features of the bidirectionally maneuverable catheter 100 in deflection and straightening configurations is illustrated. For example... Figure 5 As shown, viewed from the proximal to the distal side, clockwise rotation of the rotatable knob 124 causes the threaded member 122 to move distally within the handle 110 and / or handle housing 112, thereby applying tension to the first operating cable 130 and causing the distal portion 144 and / or the first bend 146 of the elongated sheath 140 to bend or deflect toward the handle 110 and / or handle housing 112, or toward and / or to reach a deflection configuration. Figure 6 As shown, viewed from the proximal to the distal side, counterclockwise rotation of the rotatable knob 124 moves the threaded member 122 proximally within the handle 110 and / or handle housing 112, thereby applying tension to the second operating cable 132 and causing the distal portion 144 and / or the first bend 146 of the elongated sheath 140 to bend or deflect away from the handle 110 and / or handle housing 112, or toward and / or to a straightened configuration. Other configurations may also be considered as described herein.

[0071] Figures 7-12Selected aspects and / or additional details related to the construction and / or manufacture of the elongated sheath 140 are shown. In some embodiments, the elongated sheath 140 of the bidirectional steerable catheter 100 and / or for the bidirectional steerable catheter may include an inner tubular sleeve 200 having a proximal end and a distal end. Figure 7 As shown, a method of manufacturing an elongated sheath 140 may include positioning an inner tubular sleeve 200 on a mandrel 10. After forming the elongated sheath 140, the mandrel 10 may be removed therefrom and / or the elongated sheath 140 may be removed from the mandrel 10, such that the inner tubular sleeve 200 defines an inner surface of a central lumen 143 and / or a wall 141. In some embodiments, the inner tubular sleeve 200 may be formed of a polymeric material. In some embodiments, the inner tubular sleeve 200 may be formed of two or more layers of polymeric material, wherein the two or more layers of polymeric material may each be different and / or discrete polymeric materials. In some embodiments, the two or more layers of polymeric material may be co-extruded. In some embodiments, the two or more layers of polymeric material may be adhered and / or molecularly bonded together. Other constructions are also contemplated. In one example, the inner tubular sleeve 200 may include a polytetrafluoroethylene (PTFE) liner or layer, and / or a polyether block amide (e.g., Pebax®) layer disposed on and / or radially outward of the PTFE liner or layer. Other constructions and / or polymer materials may also be considered; some non-limiting examples are described below.

[0072] In some embodiments, the elongated sheath 140 includes a distal pull ring 150. For example... Figure 7 As shown, the distal pull ring 150 may be disposed radially outside the inner tubular sleeve 200 and / or may be disposed on and / or above the inner tubular sleeve 200. A method of manufacturing the elongated sheath 140 may include positioning the distal pull ring 150 on the inner tubular sleeve 200, proximal to the distal end of the inner tubular sleeve 200. In some embodiments, the distal pull ring 150 may be at least temporarily attached to the inner tubular sleeve 200 such that the distal pull ring 150 is fixed in place along the axial and / or longitudinal direction of the inner tubular sleeve 200. In some embodiments, the distal pull ring 150 may be adhesively bonded to the inner tubular sleeve 200. In some embodiments, the distal pull ring 150 may be attached to the inner tubular sleeve 200 via reflow melting. Other configurations are also contemplated.

[0073] The first control cable 130 and the second control cable 132 may each extend proximally from the distal pull ring 150. In at least some embodiments, the distal end of the first control cable 130 may be fixedly attached to the distal pull ring 150, and the distal end of the second control cable 132 may be fixedly attached to the distal pull ring 150. The first control cable 130 and the second control cable 132 may be disposed radially outside the inner tubular sleeve 200.

[0074] In some embodiments, the elongated sheath 140 may include a first control wire tube 210 and a second control wire tube 212, each extending proximally from the distal pull ring 150. A first control wire 130 and a second control wire 132 may be slidably disposed within the first control wire tube 210 and the second control wire tube 212, respectively. In at least some embodiments, the first control wire tube 210 and the second control wire tube 212 may define a plurality of control wire lumens 145. The first control wire tube 210 and the second control wire tube 212 may be disposed radially outside the inner tubular sleeve 200. A method of manufacturing the elongated sheath 140 may include positioning the first control wire tube 210 and the second control wire tube 212 over the inner tubular sleeve 200 and extending them toward the proximal end of the inner tubular sleeve 200. In some embodiments, the first control wire tube 210 and the second control wire tube 212 may be at least temporarily attached to the inner tubular sleeve 200, such that the first control wire tube 210 and the second control wire tube 212 are fixedly positioned circumferentially, axially, and / or longitudinally along the inner tubular sleeve 200. In some embodiments, the first control wire tube 210 and the second control wire tube 212 may be adhesively bonded to the inner tubular sleeve 200. In some embodiments, the first control wire tube 210 and the second control wire tube 212 may be attached to the inner tubular sleeve 200 via reflow welding. Other configurations are also contemplated.

[0075] In some embodiments, the elongated sheath 140 may include a reinforcing braided layer 220 disposed above the inner tubular sleeve 200, between the proximal end and the distal end of the inner tubular sleeve 200, such as... Figure 7 As shown. In some embodiments, a method of manufacturing the elongated sheath 140 may include positioning a reinforcing braided layer 220 over the inner tubular sleeve 200, the distal pull ring 150, the first control wire 130, and the second control wire 132. Since the first control wire 130 may be disposed within the first control wire tube 210, and the second control wire 132 may be disposed within the second control wire tube 212, the method of manufacturing the elongated sheath 140 may include positioning the reinforcing braided layer 220 over the first control wire tube 210 and the second control wire tube 212.

[0076] In some embodiments, the distal pull ring 150 may be disposed radially inside the reinforcing braid layer 220. In some embodiments, the distal pull ring 150 may be radially disposed between the inner tubular sleeve 200 and the reinforcing braid layer 220. In some embodiments, the first control wire 130 and the second control wire 132 may be disposed radially inside the reinforcing braid layer 220. In some embodiments, the first control wire 130 and the second control wire 132 may be radially disposed between the inner tubular sleeve 200 and the reinforcing braid layer 220. In some embodiments, the first control wire tube 210 and the second control wire tube 212 may be disposed radially inside the reinforcing braid layer 220. In some embodiments, the first control wire tube 210 and the second control wire tube 212 may be radially disposed between the inner tubular sleeve 200 and the reinforcing braid layer 220.

[0077] In some embodiments, the method of manufacturing the elongated sheath 140 and / or positioning the reinforcing braided layer 220 over the inner tubular sleeve 200 may include securing the distal tubular braided layer fastener 222 (e.g., Figure 7 , Figure 9 The distal tubular braided sleeve 222 is positioned on top of the reinforcing braid 200, near, adjacent to, and / or located at the distal end of the reinforcing braid 220. In at least some embodiments, the distal tubular braided sleeve fastener 222 may be positioned on and / or around the distal end of the reinforcing braid 220. The distal tubular braided sleeve fastener 222 may be formed of a polymeric material. In one example, the distal tubular braided sleeve fastener 222 may be formed of a polyether block amide (e.g., Pebax®). Other constructions and / or polymeric materials are also contemplated, and some non-limiting examples are described below. In some embodiments, the method of manufacturing the elongated sheath 140 and / or positioning the reinforcing braid 220 on top of the inner tubular sleeve 200 may include positioning the distal heat-shrinkable sleeve 224 on top of the distal tubular braided sleeve fastener 222. In at least some embodiments, the method of manufacturing the elongated sheath 140 and / or positioning the reinforcing braided layer 220 over the inner tubular sleeve 200 may include applying heat to the distal heat-shrinkable sleeve 224 and the distal tubular braided layer fastener 222 to cause the distal tubular fabric fastener 222 to reflow and melt around the reinforcing braided layer 200 near, adjacent to, and / or located at the distal end of the reinforcing braided layer 220. In some embodiments, the distal heat-shrinkable sleeve 224 may subsequently be removed.

[0078] In some embodiments, the method of manufacturing the elongated sheath 140 and / or positioning the reinforcing braided layer 220 over the inner tubular sleeve 200 may include: after applying heat to the distal heat-shrink sleeve 224 and the distal tubular braided layer fastener 222 to cause the distal tubular fabric fastener 222 to reflow melt around the reinforcing braided layer 22, the proximal tubular braided layer fastener 226 (e.g., Figure 7 , Figure 10 The proximal tubular braided sleeve 228 is positioned on the reinforcing braided layer 200, near, adjacent to, and / or located at the proximal end of the reinforcing braided layer 220. In at least some embodiments, the proximal tubular braided sleeve fastener 226 may be positioned on and / or around the proximal end of the reinforcing braided layer 220. The proximal tubular braided sleeve fastener 226 may be formed of a polymeric material. In one example, the proximal tubular braided sleeve fastener 226 may be formed of a polyether block amide (e.g., Pebax®). Other constructions and / or polymeric materials are also contemplated, and some non-limiting examples are described below. In some embodiments, the method of manufacturing the elongated sheath 140 and / or positioning the reinforcing braided layer 220 on the inner tubular sleeve 200 may include positioning the proximal heat-shrinkable sleeve 228 on the proximal tubular braided sleeve fastener 226. In at least some embodiments, the method of manufacturing the elongated sheath 140 and / or positioning the reinforcing braided layer 220 over the inner tubular sleeve 200 may include applying heat to the proximal heat-shrinkable sleeve 228 and the proximal tubular braided layer fastener 226 to cause the proximal tubular fabric fastener 226 to reflow and melt around the reinforcing braided layer 200 near, adjacent to, and / or located at the proximal end of the reinforcing braided layer 220. In some embodiments, the proximal heat-shrinkable sleeve 228 may subsequently be removed.

[0079] In some embodiments, the elongated sheath 140 may include an outer tubular sleeve 230 covering a reinforcing braided layer 220, such as Figure 8 As shown. The outer tubular sleeve 230 may have a proximal end, a distal end, and a length defined by the proximal and distal ends. In some embodiments, a method of manufacturing the elongated sheath 140 may include positioning the outer tubular sleeve 230 on the reinforcing braided layer 220. In at least some embodiments, the distal end of the reinforcing braided layer 220 may be spaced proximally from the distal end of the outer tubular sleeve 230. The outer tubular sleeve 230 may be formed of a polymeric material. In one example, the outer tubular sleeve 230 may be formed of a polyether block amide (e.g., Pebax®). Other constructions and / or polymeric materials are also contemplated, and some non-limiting examples are described below.

[0080] In some embodiments, the outer tubular sleeve 230 may include multiple individual segments of a polymer material. In some embodiments, the multiple individual segments of the polymer material may include different physical properties and / or characteristics (e.g., hardness, stiffness, tensile strength, etc.). In some embodiments, positioning the outer tubular sleeve 230 over the reinforcing braided layer 220 may include positioning the multiple individual segments of the polymer material over the reinforcing fabric 220. In some embodiments, the multiple individual segments of the polymer material may include at least three individual segments. In some embodiments, the multiple individual segments of the polymer material may include at least four individual segments. In some embodiments, the multiple individual segments of the polymer material may include at least five individual segments. In some embodiments, each individual segment of the multiple individual segments may include the same polymer material. In one example, each individual segment of the multiple individual segments of the polymer material may include a polyether block amide (e.g., Pebax®). In some alternative embodiments, one or more individual segments of the multiple individual segments of the polymer material may include a polymer material different from the remaining segments of the multiple individual segments of the polymer material. Other configurations are also contemplated.

[0081] In some embodiments, at least three of the plurality of individual segments of the polymer material each have different physical properties and / or characteristics, and alternate longitudinally along the length of the outer tubular sleeve 230 and / or the reinforcing braided layer 220, such that adjacent individual segments have different values ​​for a particular physical property or characteristic. In some embodiments, at least three of the plurality of individual segments of the polymer material each have different hardnesses, and alternate longitudinally along the length of the outer tubular sleeve 230 and / or the reinforcing braided layer 220 (e.g., first hardness, second hardness, first hardness (or third hardness), second hardness, etc.). In some embodiments, at least three of the plurality of individual segments of the polymer material each have different stiffnesses, and alternate longitudinally along the length of the outer tubular sleeve 230 and / or the reinforcing braided layer 220. Other configurations may also be considered.

[0082] In some embodiments, at least four of the plurality of individual segments of the polymer material each have different physical properties and / or characteristics, and alternate longitudinally along the length of the outer tubular sleeve 230 and / or the reinforcing braided layer 220, such that adjacent individual segments have different values ​​for a particular physical property or characteristic. In some embodiments, at least four of the plurality of individual segments of the polymer material each have different hardnesses, and alternate longitudinally along the length of the outer tubular sleeve 230 and / or the reinforcing braided layer 220 (e.g., first hardness, second hardness, first hardness (or third hardness), second hardness, etc.). In some embodiments, at least four of the plurality of individual segments of the polymer material each have different stiffnesses, and alternate longitudinally along the length of the outer tubular sleeve 230 and / or the reinforcing braided layer 220. Other configurations may also be considered.

[0083] In some embodiments, at least five of the plurality of individual segments of the polymer material each have different physical properties and / or characteristics, and alternate longitudinally along the length of the outer tubular sleeve 230 and / or the reinforcing braided layer 220, such that adjacent individual segments have different values ​​for a particular physical property or characteristic. In some embodiments, at least five of the plurality of individual segments of the polymer material each have different hardnesses, and alternate longitudinally along the length of the outer tubular sleeve 230 and / or the reinforcing braided layer 220 (e.g., first hardness, second hardness, first hardness (or third hardness), second hardness, etc.). In some embodiments, at least five of the plurality of individual segments of the polymer material each have different stiffnesses, and alternate longitudinally along the length of the outer tubular sleeve 230 and / or the reinforcing braided layer 220. Other configurations may also be considered.

[0084] In a non-limiting example, the plurality of individual segments of the polymer material may include a first segment 232 having a Shore hardness of 72D, a second segment 233 having a Shore strength of 45D, a third segment 234 having a Shore thickness of 63D, a fourth segment 235 having a Shore density of 40D, a fifth segment 236 having a Shore hardness of 63D, and a sixth segment 238 having a Shore diameter of 35D. Other configurations, values, and / or properties may also be considered.

[0085] In some embodiments, the outer tubular sleeve 230 may include a proximal handle segment 244 of polymer material disposed above the inner tubular sleeve 200 and proximal to the reinforcing braid layer 220. In some embodiments, the proximal handle segment 244 of polymer material may have a Shore hardness of 72D. Other configurations, values, and / or properties are also contemplated. In some embodiments, two closest adjacent segments of a plurality of individual segments of polymer material may have similar Shore hardness or the same Shore strength. In some embodiments, two farthest adjacent segments of a plurality of individual segments of polymer material may have similar Shore hardness or the same Shore strength. Other configurations are also contemplated.

[0086] In some embodiments, positioning the outer tubular sleeve 230 over the reinforcing braid layer 220 may include positioning a proximal handle segment 244 of polymer material over the inner tubular sleeve 200, proximal to the reinforcing braid layer 220. In some embodiments, the proximal handle segment 244 of polymer material may include a second reinforcing braid layer 250 embedded therein. In some embodiments, the second reinforcing braid layer 250 may be embedded within the proximal handle segment 244 of polymer material before use and / or before positioning the proximal handle segment 244 of polymer material over the inner tubular sleeve 200, proximal to the reinforcing braid layer 220. In some embodiments, positioning the outer tubular sleeve 230 over the reinforcing braid layer 220 may include positioning the second reinforcing braid layer 250 over the inner tubular sleeve 200, proximal to the reinforcing braid layer 220, and then positioning the proximal handle segment 244 of polymer material over the second reinforcing braid layer 250, proximal to the reinforcing braid layer 220. Other configurations are also contemplated.

[0087] In some embodiments, the first control wire 130 and the second control wire 132 may each be disposed between the inner tubular sleeve 200 and the reinforcing braided layer 220 and / or may extend from the distal pull ring 150 to the proximal outlet position 260 between the two (e.g., Figure 8 , Figure 10The outlet position is located distal to the proximal end of the inner tubular sleeve 200 and proximal to the proximal end of the reinforcing braided layer 220. In some embodiments, the first operating wire tube 210 and the second operating wire tube 212 may each be located between the inner tubular sleeve 200 and the reinforcing braided layer 220 and / or may extend proximally from the distal pull ring 150 to the outlet position 260 between them, the outlet position being located distal to the proximal end of the inner tubular sleeve 200 and proximal to the proximal end of the reinforcing braided layer 220. The proximal end of the reinforcing braided layer 220 may be located distal to the outlet position 260. The proximal end of the outer tubular sleeve 230 may be located proximal to the outlet position 260, and / or the outlet position 260 may be located distal to the proximal end of the outer tubular sleeve 230. In some embodiments, the proximal handle segment 244 of polymer material may be located proximal to the outlet position 260. In some embodiments, the outlet position 260 may be located distal to the second reinforcing braided layer 250. In at least some embodiments, the outlet position 260 may be axially and / or longitudinally disposed between the reinforcing braid layer 220 and the second reinforcing braid layer 250. In some embodiments, the reinforcing braid layer 220 and the second reinforcing braid layer 250 may be axially and / or longitudinally spaced apart at and / or adjacent to the outlet position, such as... Figure 10 As shown.

[0088] In some embodiments, the outlet position 260 can be defined as a position where the first control wire 130 and the second control wire 132 move from the radially inner side of the reinforcing braid layer 220 and / or the outer tubular sleeve 230 to the radially outer side of the outer tubular sleeve 230. In some embodiments, the outlet position 260 can be defined as a position where the first control wire 130 and the second control wire 132 extend radially through the outer tubular sleeve 230. In some embodiments, the outlet position 260 can be defined as a position where the first control wire tube 210 and the second control wire tube 212 move from the radially inner side of the reinforcing braid layer 220 and / or the outer tubular sleeve 230 to the radially outer side of the outer tubular sleeve 230. In some embodiments, the outlet position 260 can be defined as a position where the first control wire tube 210 and the second control wire tube 212 extend radially through the outer tubular sleeve 230. The first control wire 130 and the second control wire 132 may extend proximally to and / or from the outlet position. The first control cable 130 and the second control cable 132 may extend proximally and / or radially outward from the outer tubular sleeve 230, the proximal handle section 244, and / or the second reinforcing braided layer 250, from the outlet position. The first control cable tube 210 and the second control cable tube 212 may extend proximally and / or from the outlet position. The first control cable tube 210 and the second control cable tube 212 may extend proximally and / or from the outlet position from the outer tubular sleeve 230, the proximal handle section 244, and / or the second reinforcing braided layer 250, from the outlet position.

[0089] In at least some embodiments, the first control cable tube 210 and the second control cable tube 212 may each terminate proximally at the proximal end of the reinforcing braided layer 220, distally at the proximal end of the inner tubular sleeve 200, and / or distally at the proximal end of the outer tubular sleeve 230. In some embodiments, the proximal ends of the first control cable tube 210 and the second control cable tube 212 may be located proximally at the proximal end of the reinforcing braided layer 220, distally at the proximal end of the inner tubular sleeve 200, and / or distally at the proximal end of the outer tubular sleeve 230. The first control cable 130 and the second control cable 132 may extend proximally from the proximal ends of the first control cable tube 210 and the second control cable tube 212, respectively.

[0090] In some embodiments, the elongated sheath 140 may include a distal marking strip 270 disposed distal to the distal end of the reinforcing braided layer 220, proximal to the distal end of the inner tubular sleeve 200, and proximal to the distal end of the outer tubular sleeve 230, such as at least Figure 9As shown. In at least some embodiments, the distal marking band 270 may be disposed radially outward of the inner tubular sleeve 200 and radially inward of the outer tubular sleeve 230. In some embodiments, a method of manufacturing the elongated sheath 140 may include positioning the distal marking band 270 on and / or on the inner tubular sleeve 200, proximal to the distal end of the inner tubular sleeve 200. In some embodiments, a method of manufacturing the elongated sheath 140 may include positioning the distal marking band 270 on and / or on the inner tubular sleeve 200, proximal to the distal end of the inner tubular sleeve 200, before positioning the reinforcing braided layer 220 on the inner tubular sleeve 200, the distal pull ring 150, the first operating wire 130, and the second operating wire 132.

[0091] In some embodiments, the distal marking strip 270 may be at least temporarily attached to the inner tubular sleeve 200, such that the distal marking strip 270 is fixed in place axially and / or longitudinally along the inner tubular sleeve 200. In some embodiments, the distal marking strip 270 may be adhesively bonded to the inner tubular sleeve 200. In some embodiments, the distal marking strip 270 may be attached to the inner tubular sleeve 200 via reflow melting. Other configurations are also contemplated.

[0092] In some embodiments, a method of manufacturing the elongated sheath 140 may include placing a distal marking tape heat shrink sleeve over a distal marking tape 270, and then applying heat to the distal marking tape heat shrink sleeve, the distal marking tape 270, and the inner tubular sleeve 200 to secure the distal marking tape 270 to the inner tubular sleeve 200.

[0093] In some embodiments, the elongated sheath 140 may include a proximal marking band 272 disposed proximal to the distal end of the reinforcing braided layer 220, the distal end of the inner tubular sleeve 200, and the distal end of the outer tubular sleeve 230. In at least some embodiments, the proximal marking band 272 may be disposed radially outward of the inner tubular sleeve 200, radially inward of the reinforcing braided layer 220, and radially inward of the outer tubular sleeve 230. In some embodiments, the proximal marking band 272 may be spaced apart from the distal marking band 270 on the proximal side and spaced apart from the proximal pull loop 150 on the distal side.

[0094] In some embodiments, a method of manufacturing the elongated sheath 140 may include positioning a proximal marking strip 272 on and / or on the inner tubular sleeve 200, proximal to the distal end of the inner tubular sleeve 200. In some embodiments, a method of manufacturing the elongated sheath 140 may include positioning a reinforcing braided layer 220 on the proximal marking strip 272. In some embodiments, a method of manufacturing the elongated sheath 140 may include, before positioning the reinforcing braided layer 220 on the inner tubular sleeve 200, the distal pull ring 150, the first operating wire 130, the second operating wire 132, and the proximal marking strip 272, positioning the proximal marking ring 272 on and / or on the inner tubular sleeve 200, proximal to the distal end of the inner tubular sleeve 200.

[0095] In some embodiments, the proximal marking strip 272 may be at least temporarily attached to the inner tubular sleeve 200, such that the proximal marking strip 272 is fixed in place axially and / or longitudinally along the inner tubular sleeve 200. In some embodiments, the proximal marking strip 272 may be adhesively bonded to the inner tubular sleeve 200. In some embodiments, the proximal marking strip 272 may be attached to the inner tubular sleeve 200 via reflow melting. Other configurations are also contemplated.

[0096] In some embodiments, a method of manufacturing the elongated sheath 140 may include placing a heat-shrinkable sleeve of the proximal marking tape 272 over the proximal marking tape 272, and then applying heat to the heat-shrinkable sleeve of the proximal marking tape 272, the distal marking tape 272, and the inner tubular sleeve 200 to secure the proximal marking tape 272 to the inner tubular sleeve 200.

[0097] In some embodiments, a method of manufacturing the elongated sheath 140 may include positioning the proximal marking tape heat shrink sleeve over the proximal marking tape 272 and positioning the distal marking tape heat shrink sleeve over the distal marking tape 270 before applying heat to the distal marking tape heat shrink sleeve, the proximal marking tape 272, and the inner tubular sleeve 200, to secure the distal marking tape 270 and the proximal marking tape 272 to the inner tubular sleeve 200 in a single step, operation, or process. In at least some embodiments, the distal marking tape heat shrink sleeve and the proximal marking tape heat shrink sleeve may be independent and distinct structures. In some embodiments, the distal marking tape heat shrink sleeve and the proximal marking tape heat shrink sleeve may be axially and / or longitudinally spaced apart from each other.

[0098] In some embodiments, the method of manufacturing the elongated sheath 140 may include removing the proximal marking tape heat shrink sleeve, and removing the distal marking tape heat shrink sleeve after applying heat to secure the distal marking tape 270 and the proximal marking tape 272 to the inner tubular sleeve 200. In some embodiments, the method of manufacturing the elongated sheath 140 and / or positioning the outer tubular sleeve 230 over the reinforcing braided layer 220 may include positioning the outer tubular sleeve 230 over the distal marking tape 270 and the proximal marking tape 272. In some embodiments, the method of manufacturing the elongated sheath 140 and / or positioning the outer tubular sleeve 230 over the reinforcing braided layer 220 may include positioning the outer tubular sleeve 230 over the distal marking tape 270 and the proximal marking tape 272 after removing the proximal and distal marking tape heat shrink sleeves.

[0099] In some embodiments, a method of manufacturing an elongated sheath 140 may include positioning a heat-shrinkable sleeve 246 over the outer tubular sleeve 230 after positioning an outer tubular sleeve 230 over the reinforcing braided layer 220, and / or surrounding the outer tubular sleeve 240 with the heat-shrinkable sleeve 246, such as Figure 8 As shown. In some embodiments, the method of manufacturing the elongated sheath 140 may include, after positioning the outer tubular sleeve 230 over the reinforcing braided layer 220 and / or positioning the proximal handle portion 244 of polymer material over the inner tubular sleeve 200, proximal to the reinforcing braided layer 220, positioning the proximal handle heat-shrink sleeve 248 over the proximal handle portion 244 of polymer material, as shown. Figure 8 As shown. In some embodiments, a method of manufacturing the elongated sheath 140 may include positioning a heat shrink sleeve 246 over the outer tubular sleeve 230 and the proximal handle heat shrink sleeve 248, and / or surrounding the outer tubular sleeve 230 and the proximal handle heat shrink sleeve 248 with the heat shrink sleeve 246.

[0100] A method of manufacturing the elongated sheath 140 may include applying heat to a heat-shrinkable sleeve 246 above and / or around the outer tubular sleeve 230 to cause the outer tubular sleeve 230 to reflow and melt around the reinforcing braid layer 220 and the inner tubular sleeve 200. In some embodiments, applying heat to the heat-shrinkable sleeve 246 above and / or around the outer tubular sleeve 230 may cause the proximal handle segment 244 of the polymer material to reflow and melt with a plurality of individual segments of the polymer material. In some embodiments, applying heat to the heat-shrinkable sleeve 246 above and / or around the outer tubular sleeve 230 may cause the proximal handle segment 244 of the polymer material to reflow and melt with the first segment 232. In some embodiments, applying heat to the heat shrink sleeve 246 above and / or around the outer tubular sleeve 230 can cause the polymer material to reflow and melt at the proximal handle section 244 and / or the first section 232 adjacent to the outlet position 260.

[0101] In some embodiments, the method of manufacturing the elongated sheath 140 may include subsequently removing the heat-shrink sleeve 246 over and / or around the outer tubular sleeve 230. In some embodiments, the method of manufacturing the elongated sheath 140 may include subsequently removing the heat-shrink sleeve 246 over and / or around the outer tubular sleeve 230, and removing the proximal handle heat-shrink sleeve 248.

[0102] In some embodiments, heat is applied to the heat-shrink sleeve 246 above and / or around the outer tubular sleeve 230 to cause the outer tubular sleeve 230 to reflow and melt around the reinforcing braid layer 220 and the inner tubular sleeve 200, which may cause and / or form a tapered distal region 280, such as Figure 11 As shown. In some embodiments, the tapered distal region 280 may be positioned near and / or adjacent to the distal end of the inner tubular sleeve 200 and / or the distal end of the outer tubular sleeve 230. In some embodiments, the tapered distal region 280 may be positioned near and / or adjacent to the distal end of the reinforcing braid layer 220. In some embodiments, the tapered distal region 280 may be located distal to the distal end of the reinforcing braid layer 220. In some embodiments, the sixth segment 238 may be and / or include the tapered distal region 280.

[0103] In some embodiments, the elongated sheath 140 may include a soft and / or damage-resistant distal end 142 disposed distal to the tapered distal region 280. In some embodiments, the soft and / or damage-resistant distal end 142 may be formed of a polymeric material. In some embodiments, the soft and / or damage-resistant distal end 142 may include a polyether block amide (e.g., Pebax®). In some embodiments, the soft and / or damage-resistant distal end 142 may have a Shore hardness of 35D. Other constructions, values, and / or properties may also be considered.

[0104] In some embodiments, a method of manufacturing the elongated sheath 140 may include securing and / or fixing the flexible and / or damage-resistant distal end 142 to the distal end of the inner tubular sleeve 200 and / or the distal end of the outer tubular sleeve 230 and / or at the corresponding location. In some embodiments, a method of manufacturing the elongated sheath 140 may include securing and / or fixing the flexible and / or damage-resistant distal end 142 to the distal end of the inner tubular sleeve 200 and / or the distal end of the outer tubular sleeve 230 and / or at the corresponding location via reflow melting. In some embodiments, a method of manufacturing the elongated sheath 140 may include securing and / or fixing the flexible and / or damage-resistant distal end 142 to the distal end of the inner tubular sleeve 200 and / or the distal end of the outer tubular sleeve 230 and / or at the corresponding location via adhesive bonding. Other configurations may also be considered.

[0105] In some embodiments, the method of manufacturing the elongated sheath 140 may include, after applying heat to a heat-shrinkable sleeve 246 located on and / or around the outer tubular sleeve 230, fixing and / or securely attaching a soft and / or damage-resistant distal end 142 to the distal end of the inner tubular sleeve 200 and / or the distal end of the outer tubular sleeve 230 and / or at the corresponding location, such that the outer tubular sleeve 230 reflows and melts around the reinforcing braid layer 220 and the inner tubular sleeve 200. In some embodiments, the method of manufacturing the elongated sheath 140 may include, before applying heat to the heat-shrink sleeve 246 located on and / or around the outer tubular sleeve 230, fixing and / or securing the soft and / or damage-resistant distal end 142 to the distal end of the inner tubular sleeve 200 and / or the distal end of the outer tubular sleeve 230 and / or at the corresponding location, such that the outer tubular sleeve 130 reflows and melts around the reinforcing braid layer 220 and the inner tubular sleeve 200. In some embodiments, the method of manufacturing the elongated sheath 140 may include, before positioning the heat-shrinkable sleeve 246 over the outer tubular sleeve 230, and / or before wrapping the heat-shrinkable sleeve 246 around the outer tubular sleeve 230, attaching and / or securing the soft and / or damage-resistant distal end 142 to the distal end of the inner tubular sleeve 200 and / or the distal end of the outer tubular sleeve 230 and / or at the corresponding location.

[0106] In some embodiments, the elongated sheath 140 may include a hub member 290 fixedly attached to the proximal end of the outer tubular sleeve 230, such as Figure 12As shown. In some embodiments, the elongated sheath 140 may include a hub member 290 fixedly attached to the proximal end of the proximal handle portion 244. In some embodiments, a method of manufacturing the elongated sheath 140 may include fixedly attaching the hub member 290 to the proximal end of the outer tubular sleeve 230. In some embodiments, a method of manufacturing the elongated sheath 140 may include fixedly attaching the hub member 290 to the proximal end of the proximal handle portion 244. In some embodiments, the hub member 290 may be fixedly attached to the outer tubular sleeve 230 and / or the proximal handle portion 244 via reflow melting. In some embodiments, the hub member 290 may be fixedly attached to the outer tubular sleeve 230 and / or the proximal handle portion 244 via adhesive bonding. In some embodiments, the hub member 290 may be fixedly attached to the outer tubular sleeve 230 and / or the proximal handle portion 244 via welding. Other configurations are also contemplated. In some alternative embodiments, the hub member 290 may be integrally and / or integrally formed with the outer tubular sleeve 230 and / or the proximal handle portion 244. In some embodiments, the outer tubular sleeve 230 and / or the proximal handle portion 244 may be integrally and / or integrally formed with the hub member 290 disposed at its proximal end.

[0107] In some embodiments, the elongated sheath 140 and / or its components may be heat-treated to form and / or define a normal or relaxed configuration. As described herein, the elongated sheath 140 may include a pre-defined double bend in either the normal or relaxed configuration, such as Figure 1 and Figure 4 As shown. In some embodiments, a method of manufacturing the elongated sheath 140 may include heat-treating the elongated sheath 140 and / or its components to form and / or define a normal or relaxed configuration. In some embodiments, a method of manufacturing the elongated sheath 140 may include heat-treating the elongated sheath 140 and / or its components before securing the hub member 290 to the outer tubular sleeve 230 and / or the proximal handle segment 244. In some embodiments, a method of manufacturing the elongated sheath 140 may include heat-treating the elongated sheath 140 and / or its components after securing the hub member 290 to the outer tubular sleeve 230 and / or the proximal handle segment 244. In some embodiments, in the normal or relaxed configuration of the elongated sheath 140, a pre-defined double bend may be provided between the proximal end and the distal end of the reinforcing braid layer 220. In some embodiments, the outer tubular sleeve 230 and / or the reinforcing braid layer 220 may at least partially define a normal or relaxed configuration after heat treatment. For example, in some embodiments, the outer tubular sleeve 230 and / or the reinforcing braided layer 220 may be formed of a shape memory material. Other constructions and / or materials may also be considered.

[0108] Figure 13Selected aspects of alternative constructions of the elongated sheath 140 and / or alternative aspects of methods for manufacturing the elongated sheath 140 are shown. As described herein, in some embodiments, the outer tubular sleeve 230 ( Figure 13 Positioning (not shown) above the reinforcing braid 220 may include positioning the second reinforcing braid 250 above the inner tubular sleeve 200, proximal to the reinforcing braid 220, and then positioning the proximal handle segment 244 of polymer material above the second reinforcing braid 250, proximal to the reinforcing braid 220. In some embodiments, positioning the second reinforcing braid 250 above the inner tubular sleeve 200 may include positioning the tubular braid fastener 252 above the second reinforcing braid 250, close to, adjacent to, and / or located at the distal end of the second reinforcing braid 250, such as... Figure 13 As shown. In at least some embodiments, the tubular braided layer fastener 252 may be positioned on and / or around the distal end of the second reinforcing braid 250. The tubular braided layer fastener 252 may be formed of a polymeric material. In one example, the tubular braided layer fastener 252 may be formed of a polyether block amide (e.g., Pebax®). Other constructions and / or polymeric materials are also contemplated, and some non-limiting examples are described below. In some embodiments, the method of manufacturing the elongated sheath 140 and / or positioning the second reinforcing braid 250 over the inner tubular sleeve 200 may include positioning the second reinforcing braid heat-shrink sleeve 254 over the tubular braided layer fastener 252. In at least some embodiments, the method of manufacturing the elongated sheath 140 and / or positioning the second reinforcing braid 250 over the inner tubular sleeve 200 may include applying heat to the second reinforcing braid heat-shrink sleeve 254 and the tubular braid fastener 252 such that the tubular braid fastener 252 is close to, adjacent to, and / or reflows and melts around the second reinforcing braid 250 at the distal end of the second reinforcing braid 250. In some embodiments, the second reinforcing braid heat-shrink sleeve 254 may subsequently be removed. Thereafter, the proximal handle section 244 and / or the outer tubular sleeve 230 may be positioned over the reinforcing braid 220 and the second reinforcing braid 250.

[0109] Figure 14 A selected aspect of another alternative construction of the elongated sheath 140 is shown. In some embodiments, the reinforcing braided layer 220 (e.g., Figures 7-11 , Figure 13 The second reinforcing braid 250 may be a reinforcing coil 221 and / or may be replaced by a reinforcing coil. In some embodiments, the second reinforcing braid 250 (e.g., Figure 8 , Figure 10 , Figure 13The second reinforcing coil 251 can be used and / or can be replaced by the second reinforcing coil. The construction and / or manufacturing method of the elongated sheath 140 can be substantially as described herein, while replacing the reinforcing braid 220 with the reinforcing coil 221 and replacing the second reinforcing braid 250 with the second reinforcing coil 251.

[0110] Materials that can be used for various components of the system (and / or other elements disclosed herein) and their various components may include materials commonly associated with medical devices and / or systems. For simplicity, the following discussion refers to the system. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other elements, components, parts, or devices disclosed herein, such as, but not limited to, occlusive implants, delivery sheaths, core materials, expandable frames, occlusive elements, capsules, elongated fingers, elongated strands, etc., and / or their elements or parts.

[0111] In some embodiments, the system and / or its components may be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, combinations thereof, or other suitable materials.

[0112] Examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM; e.g., DELRIN®), polyether block copolymers, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL®), ether or ester copolymers (e.g., butylene phthalate / poly(alkylene ether) esters and / or other polyester elastomers, such as HYTREL®), polyamides (e.g., DURETHAN® or CRISTAMID®), elastic polyamides, block polyamides / ethers, polyether block amides (PEBA; e.g., PEBAX®), ethylene vinyl acetate copolymers (EVA), silicone, polyethylene (PE), MARLEX® high-density polyethylene. Polyethylene, MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), polyterephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., GRILAMID®), perfluoropropyl vinyl ether (PFA), vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), polyethylene-b-isobutylene-b-styrene (e.g., SIBS and / or SIBS) 50A), polycarbonate, polyurethane-silicone copolymers (e.g., Elast Eon® or ChronoSil®), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof. In some embodiments, the system and / or its components may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6% LCP.

[0113] Some examples of suitable metals and metal alloys include stainless steels, such as 304 and / or 316 stainless steel and / or variants thereof; low-carbon steels; nickel-titanium alloys, such as linearly elastic and / or hyperelastic nickel-titanium; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; UNS: N10276, such as HASTELLOY® C276®, other HASTELLOY® alloys, etc.); and nickel-copper alloys (e.g., UNS: N04400, such as MONEL® 400, NIC...). KELVAC®400, NICORROS®400, etc.); nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.); nickel-molybdenum alloys (e.g., UNS: N10665, such as HASTELLOY® Alloy B2®); other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0114] In at least some embodiments, some or all of the system and / or its components may also be doped with, made into, or otherwise include radiopaque materials. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluorescent screen or other imaging technique (such as ultrasound) during a medical procedure. This relatively bright image helps the user of the system determine its location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marking strips and / or coils may be incorporated into the design of the system to achieve the same result.

[0115] In some embodiments, the system and / or its components may include fabric materials. The fabric materials may consist of biocompatible materials suitable for promoting tissue inward growth, such as polymeric or biomaterials. In some embodiments, the fabric materials may include bioabsorbable materials. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials such as polyethylene, polypropylene, polyester, polyurethane, and / or mixtures or combinations thereof.

[0116] In some embodiments, the system and / or its components may include and / or be formed from woven materials. Some examples of suitable woven materials may include synthetic yarns, which may be flat, shaped, twisted, textured, pre-shrinked, or unshrinked. Suitable synthetic biocompatible yarns for this disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefins, polyethylene, polyacetate, polyamide, polyethylene naphthalate derivatives, natural silk, and polytetrafluoroethylene. Furthermore, at least one of the synthetic yarns may be a metallic yarn, glass yarn, ceramic yarn, or fiber. Suitable metallic yarns include yarns made of or containing stainless steel, platinum, gold, titanium, tantalum, or nickel-cobalt-chromium based alloys. The yarn may further include carbon fibers, glass fibers, or ceramic fibers. Ideally, the yarn is made of thermoplastic materials, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The yarn may be multifilament, monofilament, or spun yarn. The type and denier of the selected yarn can be chosen in a way that creates a biocompatible and implantable prosthesis, more specifically, a vascular structure with the desired properties.

[0117] In some embodiments, the system and / or its components may include a suitable therapeutic agent and / or be treated with a suitable therapeutic agent. Examples of appropriate therapeutic agents may include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (d-phenylalanine-proline-arginine-chloromethyl ketone)), antiproliferative agents (such as enoxaparin, angiopeptidase, monoclonal antibodies that block smooth muscle cell proliferation, hirudin, and acetylsalicylic acid), anti-inflammatory agents (such as dexamethasone, prednisolone, corticosteroids, budesonide, estrogens, sulfasalazine, and mesalazine), antitumor / antiproliferative / antimitotic drugs (such as paclitaxel, 5-fluorouracil, cisplatin, vincristine, epoch-forming agents, endostatin, angiostatin, and thymidine kinase inhibitors), anesthetics (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, and antithrombin antibodies). Antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet peptides), angiogenesis promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators and translation promoters), angiogenesis inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription inhibitors, translation inhibitors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, bifunctional molecules composed of antibodies and cytotoxins), immunosuppressants (such as orolimus drugs, rapamycin analogs, macrolide antibiotics, biolimus, everolimus, zotamolimus, tesimolimus, picocrolimus, novolimus, miromolimus, tacrolimus, sirolimus, pimecrolimus, etc.), cholesterol lowering agents, vasodilators, and drugs that interfere with endogenous vasoactivity mechanisms.

[0118] It should be understood that this disclosure is illustrative in many respects. Variations in details, particularly in the shape, size, and arrangement of steps, may be made without departing from the scope of this disclosure. To the appropriate extent, this may include the use of any feature of an exemplary embodiment used in other embodiments. Of course, the scope of this disclosure is defined by the language of the appended claims.

Claims

1. A slender sheath for a bidirectional steerable catheter, comprising: An inner tubular sleeve having a proximal end and a distal end; A reinforcing braided layer is disposed above the inner tubular sleeve and between the proximal end and the distal end of the inner tubular sleeve. A distal pull ring is radially disposed between the inner tubular sleeve and the reinforcing braided layer; A first control cable and a second control cable, each extending from the distal pull ring toward the proximal side; and An outer tubular sleeve covering the reinforcing braided layer, the outer tubular sleeve having a proximal end, a distal end, and a length defined by the proximal end and the distal end; Wherein, the first control wire and the second control wire extend from the distal pull ring to the proximal end between the inner tubular sleeve and the reinforcing braided layer to the outlet position, the outlet position being located distal to the proximal end of the inner tubular sleeve; The proximal end of the outer tubular sleeve is located near the outlet position.

2. The slender sheath according to claim 1, wherein, The distal end of the reinforcing braided layer is spaced proximally from the distal end of the outer tubular sleeve, and the proximally end of the reinforcing braided layer is located distal to the outlet position.

3. The elongated sheath according to any one of claims 1-2, wherein, The first control cable and the second control cable are fixedly attached to the distal pull ring.

4. The elongated sheath according to any one of claims 1-3, further comprising a first control cable tube and a second control cable tube, each extending from the distal pull ring toward the proximal end of the outlet position, and the first control cable and the second control cable are slidably disposed within the first control cable tube and the second control cable tube, respectively.

5. The elongated sheath according to any one of claims 1-4, further comprising a distal marking strip disposed on the distal side of the distal end of the reinforcing braided layer and on the proximal side of the distal end of the outer tubular sleeve.

6. The elongated sheath according to claim 5, further comprising a proximal marking band spaced proximally from the distal marking band and spaced distally from the distal pull loop.

7. The elongated sheath according to any one of claims 1-6, further comprising a second reinforcing braid layer spaced apart from the reinforcing braid layer, wherein, The second reinforcing braided layer is disposed above the inner tubular sleeve, near the outlet position, and is covered by the outer tubular sleeve.

8. The elongated sheath according to any one of claims 1-7, wherein, The outer tubular sleeve is formed from multiple individual segments of polymer material; Among them, at least three of the plurality of individual segments each have different hardness and alternate longitudinally along the length of the outer tubular sleeve.

9. A method for manufacturing an elongated sheath for a bidirectional steerable catheter, the method comprising: Position the inner tubular sleeve on the mandrel; The distal pull ring is positioned above the inner tubular sleeve and proximal to the distal end of the inner tubular sleeve, wherein the first operating wire and the second operating wire each extend from the distal pull ring toward the proximal side. The reinforcing braided layer is positioned over the inner tubular sleeve, the distal pull ring, the first control wire, and the second control wire; Position the outer tubular sleeve above the reinforcing braided layer; The outer tubular sleeve is surrounded by a heat-shrink sleeve; and Heat is applied to cause the outer tubular sleeve to reflow and melt around the reinforcing braided layer and the inner tubular sleeve.

10. The method according to claim 9, wherein, Positioning the reinforcing braided layer further includes: Position the distal tubular braided layer fastener above the reinforcing braided layer, near the distal end of the reinforcing braided layer; Position the distal heat shrink sleeve above the distal tubular braided layer fastener; and Heat is applied to cause the distal tubular braided layer fastener to reflow and melt around the reinforcing braided layer at its distal end near the reinforcing braided layer; and After applying heat to cause the distal tubular braided layer fastener to reflow and melt: The proximal tubular braided layer fastener is positioned above the reinforcing braided layer and near the proximal end of the reinforcing braided layer; Position the proximal heat shrink sleeve above the proximal tubular braided layer fastener; and Heat is applied to cause the proximal tubular braided layer fastener to reflow and melt around the reinforcing braided layer at the proximal end near the reinforcing braided layer.

11. The method according to any one of claims 9-10, wherein, Positioning the outer tubular sleeve further includes: Multiple individual segments of the polymer material are positioned on the reinforcing braided layer; Among them, at least three of the plurality of individual segments each have different hardness and alternate longitudinally along the length of the outer tubular sleeve.

12. The method according to claim 11, wherein, Positioning the outer tubular sleeve further includes positioning a proximal handle section of polymer material above the inner tubular sleeve, near the reinforcing braid layer.

13. The method according to claim 12, wherein, Positioning the outer tubular sleeve further includes positioning the second reinforcing braid layer above the inner tubular sleeve and proximal to the reinforcing braid layer; and Subsequently, the proximal handle section of the polymer material is positioned on the second reinforcing braid layer.

14. The method according to claim 12, wherein, The proximal handle section of the polymer material includes a second reinforcing braided layer embedded therein.

15. The method of claim 15, further comprising securingly attaching the hub member to the proximal end of the outer tubular sleeve.

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