Flexible tubular elongate members for medical use and related systems and methods

Abstract

The present invention relates to a kink and / or deformation resistant flexible tubular elongate member that can be reflexed greater than 90 DEG, such as approximately 180 DEG, without kink, deformation, twist, ellipse, elongate, or otherwise changing shape and / or otherwise functionally affected by one or more lumens therethrough.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 541,160, filed September 28, 2023, and U.S. Provisional Application No. 63 / 464,007, filed May 4, 2023, the entire disclosures of which are hereby incorporated by reference herein for all purposes. TECHNICAL FIELD

[0002] The present disclosure relates to devices, systems, and methods for use during a retroflection of a medical device. More particularly, the present disclosure relates to devices and / or systems shaped to not twist or to not twist as a result of the retroflection of a medical device. Even more particularly, the present disclosure relates to a flexible tubular elongate member that maintains patency of a lumen extending therethrough upon retroflection. The flexible tubular elongate member can be configured for mounting relative to a retroflected medical device. BACKGROUND

[0003] Various medical devices are designed to be inserted into a patient’s body and are designed to articulate, flex, retroflect, etc. within that patient’s body. For example, one or more devices, instruments, tools, etc. can be advanced through one or more working channels of a medical endoscope (e.g., endoscope) to a target site within a patient’s body. Such devices can also be known as transendoscopic (“TTS”) devices. Some TTS devices can include one or more flexible tubular elongate members through which another component, device, instrument, tool, etc. can extend through the medical endoscope. Additionally or alternatively, over-the-scope (“OTS”) endoscope accessories can extend along (and optionally be attached to) an exterior surface of a medical endoscope. Various OTS devices, working in conjunction with the associated medical endoscope and one or more TTS devices, can perform various functions. Some OTS accessory devices can include one or more flexible tubular elongate members defining a lumen extending longitudinally therethrough. The lumen can be used as an auxiliary working channel, such as to supplement the working channels of the medical endoscope with which it is operatively associated, such as to accommodate actuation instruments and / or to allow one or more instruments to extend therethrough. Additionally or alternatively, the lumen can allow fluid to pass therethrough to facilitate irrigation, aspiration, insufflation, etc.

[0004] Various medical devices, including medical endoscopes, have one or more flexible elongate members and various mechanisms, such as internal pulleys and cables, to guide (e.g., navigate and bend, etc.) the flexible elongate member through a patient's body, including tortuous body passageways. For example, some flexible elongate members can articulate in one or more planes, such as for up and down movement and / or left and right movement. Articulation devices and systems can be operable to direct the flexible elongate member to a desired target site within a patient's body. In some cases, a high degree of flexing, such as to a reverse bend point (bend back), can be required to access a target site within a patient's body. However, such reverse bending can present various challenges, such as kinking of a lumen through the reverse bending member. It is with these and other considerations in mind that the present improvements can be useful. SUMMARY

[0005] This summary provides a basic introduction to some aspects of the innovation. The innovation is described in further detail below in the detailed description. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. One skilled in the art will understand that each of the aspects and features of the present disclosure can be utilized in some cases and not in others, whether described in this summary or not, and whether in combination with other aspects and features of the present disclosure or not. The inclusion or exclusion of elements, components, etc. in this summary is not intended to limit the scope of the claimed subject matter.

[0006] In accordance with various principles of the present disclosure, a flexible tubular elongate member for use with a reverse bending system is disclosed. The flexible tubular elongate member includes an outer surface and an inner surface extending between a proximal end and a distal end of the flexible tubular elongate member, the inner surface defining one or more lumens through the flexible tubular elongate member between the proximal end and the distal end of the flexible tubular elongate member; and a flexing section along a length of the flexible tubular elongate member between the proximal end and the distal end, the flexing section configured to be kink-resistant and / or deformation-resistant. In some aspects, a shape, configuration, and / or dimension of at least one of the outer surface or the inner surface of the flexing section is set to facilitate flexing of the flexing section.

[0007] In some aspects, at least one of the outer surface or the inner surface of the flexing section is corrugated. In some aspects, the flexing section is reinforced. In some aspects, the flexing section includes a wire coil between its outer surface and inner surface, the wire coil reinforcing the flexing section. In some aspects, the outer surface and the inner surface of the flexing section are corrugated due to a shape of the wire coil therebetween.

[0008] In some aspects, the flex section includes wire coils between its outer surface and inner surface to facilitate flexing of the flex section. In some aspects, the flex section further includes an outer tubular core layer over the wire coils and an inner tubular core layer within the wire coils, thereby forming a multi-layer wall of the flex section.

[0009] In some aspects, one or more wall regions of the flex section have alternating thick and thin wall thicknesses.

[0010] In some aspects, a cross-sectional shape of one or more lumens through the flex section remains substantially the same as the flex section flexes.

[0011] In some aspects, the flex section extends along a portion of a distal end of the flexible tubular elongate member.

[0012] In accordance with various principles of the present disclosure, a system for reverse-folding a flexible elongate member of a medical device includes an elongate actuation member, a distal mount, a pivot mount, and an auxiliary flexible tubular elongate member; the elongate actuation member extends along the flexible elongate member and has a proximal end and a distal end; the distal mount is configured to mount relative to a distal end of the flexible elongate member; the pivot mount is configured to mount relative to the flexible elongate member proximally of the distal mount; the auxiliary flexible tubular elongate member is configured to extend along the flexible elongate member and has a proximal end and a distal end. In some aspects, the distal end of the auxiliary flexible tubular elongate member is operatively associated with the distal mount; the distal end of the actuation member is operatively associated with the distal mount to cause flexing of the distal end of the flexible elongate member when the actuation member is pulled proximally; an actuation region of the actuation member pivots relative to the pivot mount when the actuation member is pulled proximally to cause reverse-folding of the flexible elongate member; the auxiliary flexible tubular elongate member includes a flex section that is operatively associated with the distal mount to flex when the actuation member is pulled proximally; the flex section is configured to be kink-resistant and / or deformation-resistant when flexed; and one or more lumens are defined through the flex section and have a cross-sectional shape that is unaffected and unaltered by flexing of the flex section.

[0013] In some aspects, the system further includes a flexible tubular elongate member having a proximal end and a distal end, with a lumen extending between the proximal end and the distal end. In some aspects, the actuation member extends through the flexible tubular elongate member lumen; the flexible tubular elongate member is configured for mounting relative to the flexible elongate member with the distal end of the flexible tubular elongate member proximal to the distal end of the flexible elongate member; the distal end of the flexible tubular elongate member forms a pivot mount for the actuation member; and the auxiliary flexible tubular elongate member extends along the flexible tubular elongate member with the flex section extending distally beyond the distal end of the flexible tubular elongate member to operatively associate with the distal mount. In some aspects, the flex section of the flexible tubular elongate member does not extend to the proximal end of the flexible tubular elongate member. In some aspects, the flexible tubular elongate member extends through the lumen defined through the flexible tubular elongate member.

[0014] In some aspects, the flex section has an outer surface and an inner surface defining a lumen through the flex section; and at least one of the outer surface or the inner surface of the flex section is shaped, configured, and / or dimensioned to facilitate flexing of the flex section.

[0015] In some aspects, the flex section is reinforced with a wire coil.

[0016] According to various principles of the present disclosure, a method of forming a kink- and / or deformation-resistant flex section of a flexible tubular elongate member that is insertable through a lumen into a patient includes corrugating at least one of an outer surface or an inner surface of the flex section to increase flexibility of the flex section such that a cross-sectional shape of one or more lumens defined through the flex section is not altered or affected by flexing of the flex section.

[0017] In some aspects, the method further includes corrugating both the outer surface and the inner surface of the flex section. In some aspects, the method further includes reinforcing the flex section with a wire coil. In some aspects, the method further includes forming the flex section with an outer tubular core layer over the wire coil to form an outer corrugated surface of the flex section, and disposing the wire coil over an inner tubular core layer to form an inner corrugated surface of the flex section.

[0018] These and other features and advantages of the present disclosure will be apparent from the following detailed description, which, taken in conjunction with the accompanying drawings, illustrating by way of example the principles of the present disclosure. While the following disclosure presents a number of aspects and embodiments, it is understood that the independent aspects can be claimed separately or in combination with aspects and features of this or any other embodiment. BRIEF DESCRIPTION OF DRAWINGS

[0019] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended as precise measurements. The drawings are provided for purposes of illustration only and the dimensions, positions, orders and relative sizes reflected in the drawings attached hereto can vary. For example, devices can be enlarged so that details are discernible, but are intended to be reduced, e.g., to fit within a working channel of a delivery catheter or endoscope. Not every element of every embodiment is labeled in every figure, and every element of every embodiment is also not shown in every figure, where illustration is not necessary to allow those skilled in the art to understand the present disclosure.

[0020] The DETAILED DESCRIPTION will be better understood in connection with the drawings, in which like reference numerals refer to like elements, and in which:

[0021] Figure 1 is a front view of one example embodiment of a reverse folding device and system that can be used with an auxiliary flexible tubular elongate member formed in accordance with various principles of the present disclosure;

[0022] Figure 2 is a schematic view of a reverse folding device and system, such as Figure 1 , subjected to a distal reverse fold as applied by a reverse folding system;

[0023] Figure 2A is a detailed view of a flexing section of a flexible tubular elongate member, such as shown within the dashed area of Figure 2 ;

[0024] Figure 3 is a front view of a flexible tubular elongate member having a kink- and / or deformation-resistant section formed in accordance with various principles of the present disclosure;

[0025] Figure 3A is a detailed view of a section of a flexible tubular elongate member, such as shown along the dashed area of Figure 3 ;

[0026] Figure 4 is a cross-sectional view of one example embodiment of a flexible tubular elongate member formed in accordance with various principles of the present disclosure;

[0027] Figure 5 is an exploded perspective view of a flexible tubular elongate member, such as Figure 4 ;

[0028] Figure 6 is a perspective view of an endoscopic suturing system in accordance with an embodiment of the present invention;

[0029] Figure 7 is a proximal perspective view of a suturing device of an endoscopic suturing system, such as Figure 6 ;

[0030] Figure 8 for Figure 6 The length of the endoscopic suturing system is not limited in the side front view of the suturing device;

[0031] Figure 9 A perspective view of the distal end of the cap assembly at the distal end of the endoscope, which is attached to the endoscopic suturing system;

[0032] Figure 10 A perspective view of the cap assembly of a suture device for an endoscope suture system relative to the distal end of the endoscope;

[0033] Figure 11 For crossing Figure 6 A cross-sectional view of line XI-XI;

[0034] Figure 12 A schematic diagram of the cap assembly of a suture device for an endoscopic suture system relative to the distal end of the endoscope;

[0035] Figure 13 For similar Figure 12 The view in which the endoscope is rotated and aligned;

[0036] Figure 14 For similar Figure 10 The view shows the endoscope properly oriented and advanced to the distal end of the cap assembly;

[0037] Figure 15 This is a schematic diagram of a tape applicator;

[0038] Figure 16 A schematic diagram of a tape system for securing the sheath of a suture device relative to an endoscope;

[0039] Figure 17 and Figure 18 The characteristics of the tape in the tape system are shown;

[0040] Figure 19 and Figure 20 A schematic diagram of the folding system for the endoscope system applied to the proximal handle of the system;

[0041] Figure 21 A schematic diagram showing details of one embodiment of a locking element for a reversible system;

[0042] Figure 22 A schematic diagram of an endoscope system subjected to distal folding by the folding system;

[0043] Figure 23 for Figure 21 A schematic diagram showing the operational details of the locking mechanism;

[0044] Figure 24 to Figure 28 The use of a tape applicator is shown for applying tape to a cap assembly to secure the cap assembly relative to the distal end of the endoscope.

[0045] Figure 29 The use of tape along the sheath is shown; the tape is used to secure the sheath to the endoscope.

[0046] Figure 30 to Figure 34 The use of an endoscopic system for endoscopic suturing of tissue is illustrated.

[0047] Figure 35 and Figure 36 The tape was removed from around the cap assembly;

[0048] Figure 37 The image shows the removal of the sheath from the endoscope;

[0049] Figure 38 and Figure 39 As shown Figure 12 and Figure 13 An alignment instance of the cap component. Detailed Implementation

[0050] The following detailed description should be read with reference to the accompanying drawings, which illustrate exemplary embodiments. It should be understood that this disclosure is not limited to the specific embodiments described and therefore can be modified. All devices, systems, and methods discussed herein are examples of devices and / or systems and / or methods implemented according to one or more principles of this disclosure. Each example of an embodiment is provided by way of explanation and is not the only way to implement these principles, but merely an example. Therefore, references to elements or structures or features in the drawings must be understood as references to exemplary embodiments of this disclosure and should not be construed as limiting this disclosure to the specific elements, structures, or features shown. Upon reading this disclosure, those skilled in the art will recall other examples of ways of implementing the disclosed principles. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made to this disclosure without departing from the scope and spirit of the subject matter. For example, a feature shown or described as part of one embodiment may be used in conjunction with another embodiment to produce yet another embodiment. Therefore, it is contemplated that the subject matter of this invention covers such modifications and variations falling within the scope of the appended claims and their equivalents.

[0051] It should be understood that this disclosure is set forth in detail at various levels throughout this application. In some cases, details that are not essential to understanding this disclosure or that would make other details difficult to perceive have been omitted. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope beyond the appended claims. Unless otherwise defined, the technical terms used herein should be understood as commonly understood by one of ordinary skill in the art to which this disclosure pertains. All the apparatuses and / or methods disclosed and claimed herein can be made and performed without much experimentation based on this disclosure.

[0052] As used herein, “proximal” refers to the direction or location closest to the user (medical professional or clinician or technician or operator or physician, etc.; such terms may be used interchangeably herein and are not intended to be restrictive, and include automated control systems, etc.), such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and / or the direction or location closest to the delivery device; and “distal” refers to the direction or location furthest from the user, such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and / or the direction or location closest to the delivery device. “Longitudinal” means extending along the longer or larger dimension of the element. “Longitudinal axis” extends along the longitudinal extent of the element, but is not necessarily straight, and does not necessarily include a fixed configuration in cases of element flexure or bending; and “axial” generally refers to along this longitudinal axis. However, it should be understood that references to axial or longitudinal movement relative to the system or its elements described above are not strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the referenced element. “Center” means at least approximately bisecting the center point and / or approximately equidistant from the periphery or boundary; and “central axis” means a line that, relative to an opening, at least approximately bisectes the center point of that opening, extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, channel, cavity, or hole. As used herein, “cavity” or “channel” or “hole” or “passage” is not limited to a circular cross-section. As used herein, “free end” of an element is a terminal end beyond which such element does not extend. It should be understood that terms such as at or on or adjacent to or along the end may be used interchangeably herein and are not intended to be limiting unless otherwise indicated; and are intended to indicate a general relative spatial relationship, not a precise limitation of location. As understood herein, “correspondence” is intended to cover relationships between parts, components, elements, etc., configured to interact with each other or configured to have another intended relationship with each other. Finally, references to “at” a location or part are intended to include being at or near such a location or part (e.g., along it, adjacent to it, near it, etc.).

[0053] According to various principles of this disclosure, the reversing device and system are configured for mounting relative to a flexible elongated member. At least one flexible tubular elongated member may extend along or alongside the flexible elongated member. This disclosure provides various improvements to the hinge device and system that allow desired flexure of the flexible elongated member, even flexing to the reversing point (bending backward); the device and system are operatively associated with the flexible elongated member.

[0054] It should be understood that as a portion of a flexible tubular elongated member flexes, the lumen therein also flexes. As the amount of flexing increases, the generally circular cross-section of the lumen of the flexible tubular elongated member (e.g., an open accessory channel) can elongate / ellipse, where its cross-section changes from generally circular to generally elliptical. In some cases, as the degree of flexing of currently commercially available flexible tubular elongated members increases, such as to the fold point (e.g., beyond 90° from its initial position), the cross-section of the lumen will continue to elongate until the flexible tubular elongated member folds and forms a kink. When elongated or kinked, the cross-section of the lumen through the flexible tubular elongated member twists. In some cases, twisting narrows the lumen and reduces the flow capacity through the lumen (e.g., for flushing, suction, and / or inflation), and / or increases the frictional forces applied to any instruments extending through it. In some cases, the lumen may also narrow to completely prevent instruments or fluids from passing through it. Furthermore, once a kink has formed in the lumen of a flexible tubular elongated member, the restoration of the flexible tubular elongated member to its straightened or non-flexed position may not fully restore the initial cross-sectional geometry of the lumen (e.g., the lumen may be permanently twisted), and the "kink" geometry often persists, making further use of the lumen challenging. It should be understood that the references herein to kink resistance and / or torsion resistance are not necessarily explicitly limited to kink and / or torsion, and should be understood to include other generally undesirable bending effects on the flexible tubular elongated member, such as undesirable bending effects on the shape and / or efficiency of the lumen passing through it.

[0055] According to various principles of this disclosure, the folding device and system are operatively associated with a flexible elongated member to hinge and fold it back. In some aspects, the flexible elongated member already includes a folding device and / or system (e.g., a guiding system for a flexible elongated member in the form of a medical endoscope), and the folding device and / or system of this disclosure can be used to supplement and / or increase the maximum flexural capacity of the flexible elongated member. One or more flexible tubular elongated members may extend along the flexible elongated member and the folding device. According to various principles of this disclosure, at least the distal portion of the flexible tubular elongated member that can be hinged and folded back with the flexible elongated member can be reinforced to prevent deformation, kinking, flattening, etc., of the flexible tubular elongated member, as well as deformation of the lumen therein.

[0056] In some aspects, the flexible elongated member is a medical endoscope, through which one or more working channels extend longitudinally; and the flexible tubular elongated member provides one or more auxiliary working channels adjacent to one or more working channels of the medical endoscope. However, the principles of this disclosure apply to flexible tubular elongated members associated with folding devices and / or systems, regardless of the form or characteristics of the flexible elongated member that is hinged and / or folded, and which is operatively associated with the folding device and / or system. Therefore, it should be understood that the reference herein to medical endoscopes is for convenience only, and this disclosure is not limited to the type of device operatively associated with the flexible tubular elongated member formed according to the principles of this disclosure.

[0057] Various embodiments of devices and / or systems for influencing the retraction of medical devices, and related methods, as well as various embodiments of flexible tubular elongated members that can be used with and are resistant to deformation of the lumen therein, and various methods associated therewith, will now be described with reference to the examples shown in the accompanying drawings. References to “one embodiment,” “embodiment,” “some embodiments,” “other embodiments,” etc., in this specification indicate that one or more specific features, structures, ideas, and / or characteristics according to the principles of this disclosure may be included together with that embodiment. However, such references do not necessarily imply that all embodiments include specific features, structures, ideas, and / or characteristics, or that one embodiment includes all features, structures, ideas, and / or characteristics. Some embodiments may include one or more such features, structures, ideas, and / or characteristics (and various combinations thereof). It should be understood that one or more of the features, structures, ideas, and / or characteristics described with reference to one embodiment may be combined with one or more of the features, structures, ideas, and / or characteristics of any of the other embodiments provided herein. That is, any of the features, structures, ideas, and / or characteristics described herein may be mixed and matched to produce hybrid embodiments, and such hybrid embodiments are within the scope of this disclosure. Furthermore, references to "one embodiment," "embodiment," "some embodiments," "other embodiments," etc., throughout this specification do not necessarily refer to the same embodiment, and independent or alternative embodiments are not necessarily mutually exclusive with other embodiments. It should also be understood that the various features, structures, ideas, and / or characteristics of the disclosed embodiments are independent and separate from each other, and may be used or present individually or in various combinations thereof to produce alternative embodiments that are considered part of this disclosure. Therefore, this disclosure is not limited to only the embodiments specifically described herein, as it would be too cumbersome to describe all the many possible combinations and sub-combinations of features, structures, ideas, and / or characteristics; and the exemplary embodiments disclosed herein are not intended to limit the broader aspects of this disclosure. It should be understood that the various dimensions provided herein are examples, and those skilled in the art can readily determine the standard deviations of these dimensions and appropriate acceptable ranges of deviation, which are covered by this disclosure and any claims associated therewith. The following description is merely exemplary examples of embodiments and is not intended to limit the broader aspects of this disclosure.

[0058] Turning now to the accompanying drawings, exemplary embodiments of the refracting system 1000 formed according to the various principles of this disclosure are shown. Figure 1The illustrated example of the anti-folding system 1000 includes an anti-folding device 1010 operatively associated with a flexible elongated member 1100. The flexible elongated member 1100 may be a component of a medical device, or may generally refer to a medical device (such as a medical endoscope), and is simply referred to in a non-limiting manner; because this disclosure is not intended to limit the specific flexible elongated member or medical device that will be hinged and / or anti-folded by the anti-folding device 1010 or the anti-folding system 1000 formed according to the various principles of this disclosure.

[0059] The folding device 1010 includes an actuating element 1012, which may be referred to herein (for convenience and not as a limitation) as a cable 1012. The cable 1012 is an elongated element with sufficient strength to be actuated from its proximal end 1012p to actuate its distal end 1012d a flexible elongated member 1100, with the folding device 1010 operatively associated with the flexible elongated member 1100. The cable 1012 may be made of textiles, polymers, or metal monofilaments, multifilaments, stranded cable elements, etc., materials having suitable strength, selected with reference to their longitudinal length, the flexibility of the flexible elongated member 1100, etc. The hinge and / or folding of the flexible elongated member 1100 can advantageously guide the distal working end or opening of the working channel of the flexible elongated member 1100 (medical endoscope) to a target site within the patient's body via the folding system 1000 of this disclosure. Therefore, compared to the effects previously achievable through existing technology systems and devices, the working end of a medical device (or a flexible elongated member 1100 in the form of a medical device, or a medical device extending through a working channel of a flexible elongated member in the form of a medical endoscope) can be more precisely guided to the target site.

[0060] According to the various principles of this disclosure, the distal end 1012d of the cable 1012 (adjacent to a section of the flexible elongated member 1100 hinged by the anti-folding system 1000) is operatively associated with the flexible elongated member 1100. For maximum efficiency, the distal end 1012d of the cable 1012 may be located at and / or operatively associated with the farthest end of the flexible elongated member 1100. However, it should be understood that the distal end 1012d of the cable 1012 need not be precisely located at the farthest end of the distal end 1100d of the flexible elongated member 1100; instead, it may be adjacent to the farthest end of the device to be hinged and to some extent proximal thereto. The precise location can be determined by those skilled in the art, taking into account factors such as the flexibility of the device to be hinged and the anchoring area of ​​the cable to allow deflection. The cable 1012 can be operatively associated with the flexible elongated member 1100 in any of a variety of ways, and this disclosure is not limited in this respect. For example, the folding system 1000 may include one or more mounting members configured to operatively associate the folding device 1010 with the flexible elongated member 1100. Figure 1 In the illustrated example embodiment, the folding system 1000 includes a distal mount 1020 having a section configured to engage the flexible elongated member 1100. For example, the distal mount 1020 may include a concave section whose size, shape, construction, and / or dimensions are configured to receive a section of the flexible elongated member 1100. The distal mount 1020 may extend at least 180° around the circumference of the flexible elongated member 1100, and in some embodiments, more than 180°, such as to maintain engagement with, mounting on, or otherwise of the flexible elongated member 1100 (e.g., by friction fit or interference fit). Alternatively, the distal mount 1020 may be a collar that may surround and be attached to (relative to tension, adhesion, clamping, etc.) the flexible elongated member 1100. Other configurations or forms of mounts are within the scope and spirit of this disclosure, and this disclosure is not limited in this respect. The distal end 1012d of the cable 1012 is operatively associated with, for example, a coupling (e.g., a fixed coupling) with respect to the distal mount 1020, such that when the cable 1012 is pulled proximally (e.g., by pulling its proximally end 1012p), the distal end 1012d of the cable 1012 pulls the distal mount 1020, causing the flexible elongated member 1100 to flex proximally (e.g., in the direction of the flexure arrow F), as... Figure 2 As shown.

[0061] To induce flexure of the flexible elongated member 1100, the actuation region 1012a of the cable 1012 (located proximal to its distal end 1012d) remains stationary (e.g., anchored) relative to the flexible elongated member 1100 (while remaining longitudinally movable along the flexible elongated member 1100). The actuation region 1012a can provide a pivot point for the cable 1012 to flex the flexible elongated member 1100. The distance between the actuation region 1012a and the distal end 1012d of the cable 1012 can be selected to achieve a desired bending radius. As will be understood by those skilled in the art, the material of the cable 1012 and / or the flexible elongated member 1100 can influence the selection of such a distance to achieve the desired articulation of the flexible elongated member 1100. It should also be understood that the actuation region 1012a can be positioned independently of either the lumen / operating channel through the system 1000.

[0062] In some aspects, by means of a pivot mount of actuation region 1012a, the actuation region 1012a of cable 1012 remains unmoved laterally relative to flexible elongated member 1100 and distal mount 1020. Such a pivot mount may be similar to the distal mount 1020 described above, and therefore reference is made to the description above for the sake of brevity rather than for limitation. In some aspects, the pivot mount (which laterally holds the actuation region 1012a of cable 1012 relative to flexible elongated member 110) may be the distal end 1030d of flexible tubular elongated member 1030 (e.g., sheath), which extends along flexible elongated member 1100 and defines a lumen therethrough through which cable 1012 extends translationally / movably. The flexible tubular elongated member 1030 typically extends from the proximal end 1100p of the flexible elongated member 1100 toward the distal end 1100d of the flexible elongated member 1100.

[0063] To allow operation of the cable 1012 and to provide travel (the tension of the cable 1012 relative to the flexible elongated member 1100 along this travel causes flexure of the distal flexure segment of the flexible elongated member 1100), the actuation region 1012a of the cable 1012 is spaced proximally from the distal end 1012d of the cable 1012. In some aspects, the actuation region 1012a can be considered to be defined by the position of the pivot mount of the actuation region 1012a. For example, a pivot mount similar to that configured with the distal mount 1020 is spaced proximally from the location where the distal end 1012d of the cable 1012 is operatively associated with the flexible elongated member 1100 (e.g., spaced proximally from the distal mount 1020, with which the cable 1012 is operatively associated), to achieve the desired flexure of the cable 1012 by separating the actuation region 1012a of the cable 1012 from the distal end 1012d of the cable 1012 proximally. In embodiments where the pivot mount holding the actuation region 1012a of the cable 1012 is defined by the distal end 1030d of the flexible tubular elongated member 1030, the flexible tubular elongated member 1030 does not extend along the full length of the flexible elongated member 1100. Figure 1 and Figure 2 As shown, the distal end 1030dm of an exemplary embodiment of the flexible tubular elongated member 1030 is positioned proximal to the distal end 1100d of the flexible elongated member 1100. The cable 1012 extends distally out of the flexible tubular elongated member 1030 and extends distal to the distal end 1030dm of the flexible tubular elongated member 1030 to be operatively associated with the distal end 1100d of the flexible elongated member 1100. Therefore, in some aspects, the distal end 1030dm of the flexible tubular elongated member 1030 may provide an anchoring or pivoting mount / pivot point to the actuation region 1012a of the cable 1012, such as by functioning as a pivoting mount. It should be understood that the distance between the distal end 1012d of the cable 1012 and the actuation region 1012a can affect the bending radius of the flexural region of the flexible elongated member 1100. In some embodiments, such as Figure 1 and Figure 2 As shown, the cable 1012 is operatively associated with the adapter / proximal mount 1040, which is disposed along the proximal end 1000p of the deflection system 1000, such as along the proximal end 1030p of the flexible tubular elongated member 1030, the cable 1012 of the deflection device 1010 extending along the flexible tubular elongated member 1030.

[0064] As will be understood, the folding device and / or system of this disclosure may be operatively associated with one or more devices (such as devices used in conjunction with the flexible elongated member 1100 and / or used independently) to provide further articulation, additional flexibility, and / or accessibility, such as with other devices optionally independent of the system. In some embodiments, one or more auxiliary flexible tubular elongated members 1200 may extend longitudinally generally along / alongside the flexible elongated member 1100 (e.g., along the exterior or outer surface of / alongside the flexible elongated member 1100), such as to provide one or more auxiliary working channels to the overall system; the folding system 1000 and / or device 1010 are associated with the flexible elongated member 1100. In some aspects, the distal end 1200d of the auxiliary flexible tubular elongated member 1200 is operatively associated (e.g., coupled thereto) with the distal mount 1020 of the folding system 1000, such that the auxiliary flexible tubular elongated member 1200 is folded in a manner similar to the folding of the flexible elongated member 1100 described above. In some aspects, the proximal mount 1040 is configured to facilitate the advancement of a device through a lumen defined within a flexible tubular elongated member 1030, such as by providing ports 1041, 1043 that facilitate access to the lumen within the flexible tubular elongated member 1030. In some embodiments, a folding system 1000 formed according to various principles of the present disclosure may be operatively associated with a flexible elongated member 1100, wherein one or more working channels define / extend through the flexible elongated member 1100. In some aspects, each of one or more auxiliary flexible tubular elongated members 1200 has at least one auxiliary working channel defined therethrough. The auxiliary working channels of the auxiliary flexible tubular elongated members 1200 reinforce the working channels of the overall system (e.g., providing working channels in addition to those provided by the flexible elongated member 1100). Additional devices may extend through the auxiliary working channels defined through the auxiliary flexible tubular elongated members 1200.

[0065] According to the various principles of this disclosure, the folding system 1000 formed according to the various principles of this disclosure can hinge, flex, and / or fold a flexible tubular elongated member operatively associated therewith to a degree that can cause the lumen passing through the flexible tubular elongated member to elongate or ellipse (e.g., if the neutral elongation of the flexible tubular elongated member is configured as circular) or even become distorted. If the lumen is distorted, it cannot be properly used as a working channel through which other instruments or materials can be effectively transported, extracted, etc. In more severe cases, flexure or folding of the flexible tubular elongated member can cause permanent distortion of the lumen. For example, flexure of the flexible tubular elongated member greater than about 90°, such as flexure greater than about 145°, such as flexure greater than about 180°, and flexure of up to or even greater than about 210° (inclusive of increments therebetween, such as increments of 1°) can distort the lumen therein. The same problem applies to the lumen of the auxiliary flexible tubular elongated member 1200 used with system 1000.

[0066] Based on the various principles of this disclosure, the shape, construction, and / or dimensions of a flexible tubular elongated member (operably associated with a folding system and / or device such as those disclosed herein) are configured to resist kinking or other bending or deflection in a manner that could twist the lumen therein or otherwise affect the shape and / or function of the lumen. It should be understood that anti-kinking and / or anti-torsion are referred to herein for simplicity and not for limitation. In some aspects, the shape, construction, dimensions, etc., of at least one segment of the flexible tubular elongated member (e.g., a feature of the wall of the flexible tubular elongated member) are configured to facilitate increased bending without causing kinking or twisting of the lumen defined therein. In some aspects, the material of the flexible tubular elongated member is reinforced. In some aspects, the shape, construction, dimensions, etc., of the flexible tubular elongated member are modified by adding reinforcing material and / or structures to the wall of the flexible tubular elongated member. It should be understood that references to improvements in flexible tubular elongated members are intended to include auxiliary flexible tubular elongated members such as those described herein; and the reference to “auxiliary” flexible tubular elongated members generally applies to flexible tubular elongated members unless otherwise indicated. In some embodiments of one or more flexible tubular elongated members formed according to various principles of this disclosure to resist deformation / kink, a segment of the flexible tubular elongated member is configured to facilitate the flexural action of such a segment of the flexible tubular elongated member without kink and / or deformation. Figure 2 As shown and Figure 3In the exemplary embodiment of the auxiliary flexible tubular elongated member 1200 shown separately, only the flexural segment 1200f (i.e., and not its entire longitudinal extent / length) of the auxiliary flexible tubular elongated member 1200 is kink-resistant and / or deformation-resistant. In the illustrated exemplary embodiment, the flexural segment 1200f is along the distal end 1200d of the auxiliary flexible tubular elongated member 1200. However, this disclosure is not intended to be limiting in this respect.

[0067] The kink-resistant and / or deformation-resistant flexural segments of the flexible tubular elongated member formed according to various principles of this disclosure can be formed in a variety of forms to obtain the desired resistance to kinking and / or twisting. In some aspects, at least one segment of the flexible tubular elongated member may be configured as a multi-jointed structure to facilitate its flexure. In some embodiments, the shape, configuration, and / or dimensions of one or both of the surface (e.g., an outer or inner surface, such as the surface defining the lumen of the flexible tubular elongated member) and / or the cross-sectional shape of the flexible tubular elongated member of at least one segment are set to facilitate the flexure of such segments without kinking and / or deformation. In some embodiments, the segments of the flexible tubular elongated member formed according to various principles of this disclosure are corrugated, or otherwise shaped to be non-straight or flat to facilitate its flexure. It should be understood that the configuration of segments of the flexible tubular elongated member (facilitating flexure without kinking) can be described as corrugated, accordion-bellows-like, grooved, or otherwise non-straight / flat; those skilled in the art can understand the nature of the segments based on the following description. In some aspects, a series of ridges may be formed on the surface (outer and / or inner surfaces) of a portion of the flexible tubular elongated member when viewed laterally and / or in cross-section. In some aspects, the walls of the kink-resistant and / or deformation-resistant flexible tubular elongated member formed according to various principles of this disclosure may have segments with alternating wall thicknesses, such as circumferentially extending regions or segments of alternating thickness along the longitudinal axis of the flexible tubular elongated member 1200. In other words, the walls of the kink-resistant and / or deformation-resistant flexible tubular elongated member may include one or more wall regions that are thinner than the adjacent and distal wall regions. The walls of flexible tubular elongated members with ridges or corrugations formed according to the various principles of this disclosure can facilitate flexure, such as by making the walls more elastic and / or by reducing the stress on the walls, such as in thinner areas (which are more flexible than thicker areas), and / or by stretching or otherwise adapting to the difference in curvature between the inner and outer curvatures of the curved portion of the flexible tubular elongated member.

[0068] Example embodiments of kink-resistant and / or deformation-resistant flexible tubular elongated members are shown in detailed views. Figure 2A middle, Figure 2A It shows Figure 2The distal portion 1200d of the auxiliary flexible tubular elongated member 1200. (See reference...) Figure 2A It is understood that at least the outer surface of the illustrated segment (the visible outer surface shown) is corrugated. As the flexible tubular elongated member 1200 flexes, the geometry of the ridge (or other corrugated shape) allows for a greater degree of deflection while maintaining the cross-sectional (typically circular) geometry of the flexible tubular elongated member 1200. In some aspects, Figure 2A The shape / configuration of at least the outer surface of a segment of the flexible tubular elongated member 1200 shown is similar to that of a bellows or an accordion, thereby allowing the inner radius of the flexible tubular elongated member 1200 to collapse and the outer radius of the flexible tubular elongated member 1200 to expand. Figure 3 An example embodiment of such a configuration of at least the outer surface of the flexural segment 1200f of the illustrated auxiliary flexible tubular elongated member 1200 is shown in detailed views. Figure 3A In this context, it is understood that, compared to flexible tubular slender members achievable through existing technologies, flexible tubular slender members with corrugations, etc., allow for greater flexibility, while the lumens within are free from kinks and twists.

[0069] As used in conjunction with the folding system 1000 and / or device 1010 as described herein, such as Figure 1 and Figure 2 As shown, the auxiliary flexible tubular elongated member 1200 formed according to various principles of this disclosure allows the delivery of a device or material through its lumen, extending not only linearly from the auxiliary flexible tubular elongated member 1200 and relative to its lumen, but also at various angles relative to the more proximal portion of the auxiliary flexible tubular elongated member 1200 (the portion extending proximal to the flexural section of the auxiliary flexible tubular elongated member 1200). More specifically, the device or material delivered through the kink-resistant and / or torsion-resistant auxiliary flexible tubular elongated member 1200 formed according to various principles of this disclosure can extend at an angle greater than about 90° to the initial distal extension direction of the auxiliary flexible tubular elongated member 1200, and in a direction toward the proximal end of the auxiliary flexible tubular elongated member 1200 (such as...). Figure 2 (As shown) extension. As can be understood, the flexural segment 1200f of the anti-kink and / or anti-torsion auxiliary flexible tubular elongated member 1200 flexes from its initial distal direction (typically aligned with its more proximal extension) toward the proximal end 1200p of the auxiliary flexible tubular elongated member 1200 without twisting or otherwise impeding the transport of device and / or material through the distal flexural segment 1200f, as referenced. Figure 2AUnderstandably. Based on the foregoing, the anti-kink system 1000 and / or device 1010 formed according to the various principles of this disclosure allows the distal flexural segment 1200f of the anti-kink and / or anti-torsion auxiliary flexible tubular elongated member 1200 to flex from an initial position by more than about 90°, such as more than about 145°, such as more than about 180°, and at most or even more than about 210° (including various increments therebetween, such as increments of 1°); this initial position extends in a distal direction relative to the system 1000 / device 1010 (and generally extends from the initial position, which is axially aligned with the proximal portion of the auxiliary flexible tubular elongated member 1200). Furthermore, based on the foregoing, the anti-kink and / or anti-torsion walls of the auxiliary flexible tubular elongated member 1200 allow a device or material to pass through its lumen without affecting the transport and / or movement of the device or material due to the flexural deformation of the auxiliary flexible tubular elongated member 1200.

[0070] It should be understood that the formation of corrugations along the flexible tubular elongated member (such as by providing wall segments that are thinner than adjacent segments on their proximal or distal sides) can lead to a loss of column strength and / or other weakening of the flexible tubular elongated member. In some embodiments, the walls of the kink-resistant and / or deformation-resistant flexible tubular elongated member formed according to various principles of this disclosure are reinforced. In some embodiments, the kink-resistant and / or deformation-resistant flexible tubular elongated member is reinforced with filaments, wires, braids, meshes, etc., that are more rigid than the material from which the tubular elongated member is made. For example, the kink-resistant and / or deformation-resistant flexible tubular elongated member may have tubular walls made of flexible, elastic, biocompatible materials (e.g., polymers, such as thermoplastic elastomers, or PEBAX® block copolymers composed of rigid polyamide blocks and flexible polyether blocks), and the filaments may be made of more rigid materials (such as metals). In some embodiments, the filament is a coiled metal wire extending through the wall of an anti-kink and / or anti-deformation flexible tubular elongated member formed according to various principles of this disclosure. In some aspects, the filament extends through the thicker portion of the corrugated wall. In some aspects, the filament contributes to an increase in wall thickness. In some embodiments, the filament is a round or flat wire. If the filament is braided or in a mesh configuration, the pattern of the braid may be a wire pitch of 1:1, 1:2, 2:2, etc., and such wire pitch can be selected and / or controlled to impart various levels of reinforcement.

[0071] In some aspects, polymer tubular walls are formed on the coiled wire to create helical grooves in the resulting flexible tubular elongated member, the helical grooves conforming to the external geometry of the coiled wire, thereby forming an anti-kink and / or anti-deformation flexible tubular elongated member according to various principles of this disclosure. In some aspects, the anti-kink and / or anti-deformation flexible tubular elongated member 1200 of this disclosure comprises an inner tubular core layer, a coiled wire, and an outer tubular core layer; the coiled wire is disposed on the inner tubular core layer; the outer tubular core layer is disposed on the coiled wire, such as… Figure 4 As shown ( Figure 4 A cross-section of an exemplary embodiment of a multilayered wall of an anti-kink and / or anti-deformation flexible tubular elongated member formed according to various principles of the present disclosure is shown. Figure 5 In this system, the inner layer (also referred to as the inner core), the coiled wire, and the outer layer (also referred to as the outer core) can be combined in any of a variety of ways to achieve strong adhesion therebetween. For example, at least the materials of the inner and outer layers can be fused together (e.g., by the spacing between the coils of the wire located therebetween). In some aspects, various parameters of the reinforcing coils (e.g., the spacing / pitch between coils, the wire diameter, the wire shape, such as the cross-sectional shape (circular / flat / square) etc.) can be tuned to the specific needs of the system, and an anti-kink and / or anti-deformation flexible tubular elongated member will be used in the system. Furthermore or alternatively, the filler between the inner layer and / or between the outer layer and the coil spacing can be tuned to achieve a desired corrugated effect on the outer and / or inner diameter of the anti-kink and / or anti-deformation flexible tubular elongated member. After the fusion of the inner core, the coiled wire, and the outer core, the outer surface of the reinforcing conduit has a helical groove that conforms to the external geometry of the coiled wire, such as... Figure 3A As shown. It should be understood that, Figure 3A The configuration shown is not limited to such configurations derived from kink-resistant and / or deformation-resistant flexible tubular elongated members.

[0072] As referenced above Figure 2As described in the exemplary embodiments of the illustrated deflection system 1000 and deflection device 1010, the distal end 1030dm of the flexible tubular elongated member 1030 of the illustrated deflection system 1000 is spaced proximally from the distal mount 1020, and the distal end 1012d of the cable 1012 is operatively associated with the distal mount 1020. In some embodiments, the flexible tubular elongated member 1030 includes one or more lumens therethrough, through which an auxiliary flexible tubular elongated member 1200 may extend. It is desirable that the distal end 1200d of the auxiliary flexible tubular elongated member 1200 extends to substantially the same position as the distal end 1100d of the flexible elongated member 1100 (e.g., when extending the instrument to a target site, the flexible elongated member 1100 will be located at the target site). Because the flexible tubular elongated member 1030 is shorter than the flexible elongated member 1100 (along which the flexible tubular elongated member 1030 extends), the auxiliary flexible tubular elongated member 1200 must extend beyond the most distal end 1030dm of the flexible tubular elongated member 1030 to reach the distal end 1100d of the system 1000. It should be noted that although the auxiliary flexible tubular elongated member 1200 is shown as being away from the flexible tubular elongated member 1030 at approximately the same axial position (where the cable 1012 is away), and / or at approximately the same position as the pivot mount of the actuation region 1012a of the cable 1012, this axial position (where the auxiliary flexible tubular elongated member 1200 is away from the flexible tubular elongated member 1030) can be near or far from the pivot mount of the actuation region 1012a of the cable 1012, and this disclosure is not limited in this respect. The flexible tubular elongated member 1030 can provide sufficient reinforcement to the portion of the auxiliary flexible tubular elongated member 1200 extending through it. Therefore, the portion of the auxiliary flexible tubular elongated member 1200 extending through the flexible tubular elongated member 1030 does not require additional reinforcement, as additional reinforcement can be provided in the portions extending outside the flexible tubular elongated member 1030 and / or in the portions extending distally beyond it. In some aspects, the portions of the auxiliary flexible tubular elongated member 1200 extending within the flexible tubular elongated member 1030 are constructed using standard materials, such as thermoplastic elastomers, which are extruded to form a desired shape, including forming one or more open lumens. These one or more lumens may have a generally circular cross-section. In some aspects, instead of the flexible tubular elongated member 1030 or the auxiliary flexible tubular elongated member 1200, or other alternatives, each lumen of the flexible tubular elongated member 1030 may also be individually reinforced.

[0073] The distal portion 1200d of the auxiliary flexible tubular elongated member 1200 (extending beyond the distal end 1030dm of the flexible tubular elongated member 1030) is a portion folded back by the folding system 1000 and the device 1010. Therefore, in some aspects, only the distal portion 1200d of the auxiliary flexible tubular elongated member 1200 (extending beyond the distal end 1030dm of the flexible tubular elongated member 1030) is reinforced according to various principles of this disclosure, or otherwise formed to resist kinking and / or deformation. In other words, the flexural segment 1200f of the auxiliary flexible tubular elongated member 1200 may be provided at least (and in some aspects, only) along a segment of the auxiliary flexible tubular elongated member 1200 extending distal to the distal end 1030dm of the flexible tubular elongated member 1030.

[0074] The kink-resistant and / or deformation-resistant distal flexural segment 1200f may be bonded, welded, or otherwise joined (preferably, fixedly joined) to the proximal portion of the auxiliary flexible tubular elongated member 1200. The proximal (unreinforced) portion of the kink-resistant and / or deformation-resistant flexible tubular elongated member and the distal portion of the kink-resistant and / or deformation-resistant flexible tubular elongated member may be combined in any manner known to those skilled in the art to achieve a desired adhesive connection to maintain the connection during normal use of the kink-resistant and / or deformation-resistant flexible tubular elongated member.

[0075] The length of the distal flexure segment 1200f can be selected based on the distance between the distal end 1030dm of the flexible tubular elongated member 1030 and the distal end 1000d of the system 1000 (e.g., the location of the distal mount 1002 and / or the distal end 1100d of the flexible elongated member 1100). In embodiments where the flexible elongated member 1100 is a medical endoscope, the length of the distal flexure segment 1200f can correspond to the length of the distal “bent segment” of a standard medical endoscope. Because the length of the kink-resistant and / or deformation-resistant flexible tubular elongated member can be more expensive to manufacture than the more typical proximal segment of the kink-resistant and / or deformation-resistant flexible tubular elongated member, the overall cost of the kink-resistant and / or deformation-resistant flexible tubular elongated member can be reduced by forming only the portion experiencing the greatest flexure / torsion as kink-resistant and / or deformation-resistant.

[0076] As will be understood, the kink-resistant and / or deformation-resistant flexible tubular elongated members formed according to the various principles of this disclosure are configured to allow unimpeded movement of devices or materials through their lumens, even under conditions of extreme flexural strength. According to the various principles of this disclosure, to further facilitate the movement of devices or materials through the lumens of the kink-resistant and / or deformation-resistant flexible tubular elongated members, the lumens may be coated and / or impregnated and / or shaped with friction-reducing and / or lubricating materials. In some aspects, such materials are confined to the distal flexural portion of the kink-resistant and / or deformation-resistant flexible tubular elongated member. However, it should be understood that, where necessary, such materials may be provided along the full length of the kink-resistant and / or deformation-resistant flexible tubular elongated member. In some aspects, for one or more purposes (e.g., such as reducing friction between the lumen within the flexible tubular elongated member 1200 and another element extending through it), additives may be included in the material of the auxiliary flexible tubular elongated member 1200. For example, one or more additives can be blended / mixed with various elastomers, such as block copolymers composed of rigid polyamide blocks and flexible polyether blocks, such as the raw material PEBAX®, to achieve desired properties, such as generally improving the function of auxiliary flexible tubular elongated members, kink-resistant and / or deformation-resistant flexible tubular elongated members and / or systems. In some aspects, the material is a polytetrafluoroethylene (PTFE) material, such as 2 μm particles dispersed in or coated thereon in the tubular wall of the kink-resistant and / or deformation-resistant flexible tubular elongated member. In some cases, the material is flushed through the lumen of the kink-resistant and / or deformation-resistant flexible tubular elongated member. In some aspects, the material flushed through the lumen contains a solvent that leaves a thin layer of friction-reducing and / or lubricating material (such as PTFE). Additionally or alternatively, a low-friction liner layer (e.g., formed of PTFE) may be added, such as in the form of a flushing fluid (e.g., a PTFE flushing fluid, or another flushable PTFE-based solvent-carrying solution), and / or as a layer fused to the inner / inner surface of the lumen defined by the auxiliary flexible tubular elongated member 1200. In some aspects, the lumen of the flexible tubular elongated member 1200 may be otherwise reinforced to allow incremental or maximum deflection without kinking. It should be understood that various other lumens of the system 1000 described herein may also benefit from such treatment.

[0077] It should be understood that the proximal section of an anti-kink and / or anti-deformation flexible tubular elongated member (which may not be as anti-kink or anti-deformation as the distal flexural section) may have friction-reducing additives or coatings extending through a lumen therein, or any other treatment as described with respect to the distal section of an anti-torque and / or anti-deformation flexible tubular elongated member. The friction-reducing and / or lubricating material within the lumen of the distal flexural section may reduce friction or provide, or even further lubrication, depending on its extreme flexure and the resulting flexure of its lumen.

[0078] While the above disclosure pertains to flexible tubular elongated members used in conjunction with deflection devices and / or systems, the principles of this disclosure can be implemented or applied to any flexible tubular elongated member having a lumen or channel subjected to a high degree of deflection, such as deflection of up to and greater than 180 degrees.

[0079] Based on the foregoing, it should be understood that the anti-folding system 1000 formed according to the various principles of this disclosure can be used with the hinge mechanism of the flexible elongated member 1100, and the anti-folding system 1000 operates together with the hinge mechanism. In this manner, the anti-folding system 1000 operates as an aid to the existing system of the flexible elongated member 1100, such as to standardize the hinge function of the original system of the flexible elongated member 1100. The anti-folding system 1000 of this disclosure ensures that the desired degree of anti-folding is achieved for the surgery to be performed using the flexible elongated member 1100. In some aspects, the anti-folding system 1000 formed according to the various principles of this disclosure is advantageous for hinges, and the anti-folding system 1000 will be used in conjunction with and mounted relative to existing devices or systems. For example, the tension of an actuating device (such as the cable 1012 of the above-described example embodiment of the deflection system 1000, which extends along / beside / alongside the actuating device or system) applies a tangential force that can apply a larger force to the device or system than that applied by an actuating element extending through it (extending within the device / system, not outside it). Furthermore, the deflection system 1000 can be applied to various auxiliary devices, such as an auxiliary flexible tubular elongated member 1200 extending along a flexible elongated member 1100. The deflection system 1000, as described herein, allows for a greater degree or magnitude of deflection than previously achievable. Additionally, kink-resistant and / or deformation-resistant flexible tubular elongated members formed according to various principles of this disclosure are usable with such a deflection system 1000 without kinking, deformation, twisting, or other unintended functional failures.

[0080] The various principles of this disclosure, such as those described above, can be implemented in a variety of ways and / or applied to a variety of medical devices, examples of which will now be described. It should be understood that the various methods described with respect to the exemplary embodiments described herein can be applied to other embodiments, such as those described more broadly / generally above.

[0081] refer to Figure 6 to Figure 9The endoscopic treatment system 10 includes an endoscope system 11 and an endoscopic suturing system 21. The endoscope system 11 includes an endoscope 12, a video display unit 14, an image processing device 16, a light source 18, and a suction device 20. According to one embodiment, the endoscope 12 has a small profile, approximately 5 mm to 10 mm in diameter. However, the size of the endoscope is non-critical, and the elements described herein can be adapted to other sizes of endoscopes. In the illustrated example embodiment, the endoscope 12 has a single instrument channel 13 and an optical lens 15 (…). Figure 9 However, the endoscope 12 may have more than one instrument channel or no instrument channel at all, because the operation of the system does not necessarily require the use of an instrument channel through the endoscope. The endoscope 12 includes a distal end 44 and a proximal end 45, and a longitudinal axis A extending therebetween.

[0082] The suture system 21 includes a suture device 22 ( Figure 7 ), needle assembly 70 ( Figure 9 ), and the first device 38 and the second device 40 ( Figure 9 The needle assembly 70 is movable through the tissue via the suturing device 22, and the first device 38 and the second device 40 are used in conjunction with the suturing device 22.

[0083] refer to Figure 6 , Figure 7 and Figure 8 The suturing device 22 has a proximal operable handle 24, which is provided with a mounting bracket 26 and a collar 28. The handle is removably connected to the endoscope 12 at the collar 28. The bracket 26 includes first and second instrument ports 30, 32, at which instruments can be received into a first catheter 34 and a second catheter 36, respectively. First and second tubular connectors 33, 35 are aligned with the ports 30, 32 to connect the ports 30, 32 to the first catheter 34 and the second catheter 36.

[0084] The transmission assembly 42 includes a transmission sheath 46 and a transmission cable 48 both connected relative to the handle 24, the transmission cable 48 being movable within the transmission sheath 46. The transmission sheath 46 is connected relative to a first portion (i.e., a stationary member) of the handle, and the transmission cable 48 is connected to a second portion (i.e., a movable member) of the handle, such that when the handle 24 is operated, the cable 48 is moved within the transmission sheath 46.

[0085] The first catheter 34 and the second catheter 36, along with the transmission assembly 42, extend along the outer side of the endoscope 12 from the proximal handle 24 to the distal cap assembly 50. The distal cap assembly 50 is adapted to be mounted at the distal end 44 of the endoscope 12, and the handle 24 remotely operates the cap assembly 50 via the transmission assembly 42.

[0086] refer to Figure 9 The cap assembly 50 includes a mounting member 52, a U-shaped support bracket 54, and a needle arm portion 58. The U-shaped support bracket 54 extends distally from the mounting member, and the needle arm portion 58 is rotatably mounted on the bracket 54 via a first pin 60. A bell crank 64 is rotatably mounted on the support bracket 54 at a second pin 66 and engages the needle arm portion 58 at a meshing gear (not shown). The distal end of the transmission cable 48 of the transmission assembly 42 is attached to the bell crank 64 at a fork connector 68. When the transmission assembly 42 is operated via the handle 24, this operation results in rotation of the bell crank 64 and subsequent rotation of the needle arm portion 58 between an open position and a closed position.

[0087] Needle assembly 70 is connected to needle mount 83 at the end of needle arm portion 58. Needle assembly 70 includes a tubular needle body 74, a needle tip 76, and a suture 78 connected to the needle body. Needle body 74 includes a side opening 80, a first end portion 82, and a second end portion 84; suture 78 extends through the side opening 80; needle assembly is connected to needle mount 83 at the first end portion 82; needle tip 76 is connected to the second end portion 84. Needle tip 76 defines a tissue-piercing cone. Suture 78 may be made of any material commonly used in surgical sutures, such as nylon, polyolefin, PLA, PGA, stainless steel, nitinol, etc. A suitable needle assembly is described in more detail in U.S. Patent 9,198,562, which is incorporated herein by reference in its entirety for all purposes.

[0088] refer to Figure 9 and Figure 10 The mounting member 52 of the cap assembly 50 includes a side recess 85, a first through-hole 86, and a second through-hole 88; the transfer assembly 42 is received in the side recess 85. When the needle arm 58 is in the closed position, the first through-hole 86 is positioned to align with both the needle mounting member 83 and the needle assembly 70 of the needle arm 58. A tissue guide 87 extends distally from the first through-hole 86 on the mounting member 52 and provides a surface on which tissue is stabilized as it is pierced by the needle assembly 70. The second through-hole 88 is located between the first through-hole 86 and the support bracket 54. More specifically, the axial center of the second through-hole 88 is located between the first through-hole 86 and the pin 60 (or axis) on which the end effector and / or assembly 58 rotates. The first through-hole 86 and the second through-hole 88 may be parallel to each other and parallel to the longitudinal axis A of the endoscope; or the second through-hole 88 may be angled relative to the first through-hole 86 to guide the second device 40 into the needle path in a specific orientation, as further described below. The mounting member 52 is configured such that when the cap assembly 50 is attached to the endoscope 12 (as described below), the first through-hole 86 and the second through-hole 88 are radially outside the contour of the endoscope 12.

[0089] refer toFigure 8 and Figure 11 The distal end of the first conduit 34 is fixed in the first through-hole 86, and its proximal end is connected to the first connector 33 on the handle support 26. The distal end of the second conduit 36 ​​is fixed in the second through-hole 88, and its proximal end is connected to the second connector 35 on the handle support 26. The first conduit 34 and the second conduit 36 ​​may be separate conduits or may be independent lumens of a common conduit. In a preferred embodiment, the conduits 34, 36 are separate conduits covered along their substantially entire length (e.g., at least 80%, and more preferably at least 90%) by a preferably crescent-shaped common sheath 89. Alternatively, the common sheath 89 may extend along a portion of the overall length of the conduits 34, 36; or it may be segmented along selected portions of the conduits 34, 36. In a preferred embodiment, the common sheath 89 is flexible and defines a lumen 90 for catheter 34, a lumen 92 for catheter 36, and a lumen 94 for both the delivery assembly 42 and the folded cable 100; the function of these lumens is described below. Optionally, separate lumens may be provided for the delivery assembly 42 and the cable 100. A concave recess 96 is provided along the length of the sheath 89 such that the sheath is preferably adapted to be adjacent to the external extension of a suitably sized endoscope 12. In one embodiment, the sheath 89 is adapted to receive the endoscope such that the sheath preferably extends more than 180° around the circumference of the suitably sized endoscope 12 and thus partially surrounds the external portion of the suitably sized endoscope 12.

[0090] refer to Figure 8 and Figure 9 The first conduit 34 is adapted to receive a first device 38 having a distal end actuator that can receive and grasp the needle assembly 70. The second conduit 36 ​​is adapted to receive a second device 40 having a distal end actuator that can engage tissue and pull the tissue back into the needle path, such that the tissue can be punctured by the needle assembly 70 as it moves from an open position to a closed position.

[0091] refer to Figure 10 The cap assembly 50 is secured to the distal end 44 of the endoscope 12 by a peripheral engagement structure adapted to be positioned approximately 180° around the circumference of the distal end 12, and preferably slightly greater than 180°. In one embodiment, this structure is an elastic clamp 102 integrated into the proximal end of the mounting member 52. The clamp 102 includes an opening 104 to allow the distal end 44 of the endoscope 12 to pass through. The clamp 102 may be made of ABS plastic, other suitable plastics, elastic materials, and polymer-coated metal.

[0092] Turn Figure 10 , Figure 12 , Figure 13 andFigure 14 A stop 106 is formed at the distal end of the clamp 102. The distal end 44 of the endoscope 12 is adapted to be pushed into the recess 104 of the clamp 102 and positioned against the stop 106. The stop 106 preferably includes a maximum first clearance window and smaller second and third clearance windows; the maximum first clearance window is formed as a first recess 108 in the circumference of the stop 106 to allow passage and access to the instrument channel 13 on various endoscopes from multiple manufacturers when the endoscope is properly rotated and aligned in the clamp 102; the smaller second and third clearance windows are formed as a second recess 110 and a third recess 111 at approximately 60° on either side of the first recess 108 to prevent obstruction of the optical lenses 15 and other working features of the various endoscopes. The first recess 108 is positioned radially inward from the instrument channel lumen 88. To align endoscope features with respect to the first recess 108, the second recess 110, and the third recess 111, the stop 106 includes a mark 112 to which the instrument channel 13 or other designated features of the endoscope are rotatably aligned. For example, if the endoscope does not include the instrument channel 13 (which is not required in the system described herein), then the optical lens may be designated to align with the mark 112. In a preferred embodiment, the mark 112 is a contrasting color relative to the color of most of the cap assembly, which is set around the first recess 108. Due to this rotatable alignment of the endoscope features with respect to the mark 112 (in the direction of arrow 115), regardless of the major manufacturer of the endoscope used with the system, the endoscope's optical lens 15 ensures an unobstructed view and proper orientation relative to the suture arm 58, the instrument channel lumen 88, and the needle exchange lumen 86 without activating the endoscope. That is, relative orientation, access, and field of view can be determined without opening the endoscope or the field of view of the lens 13 on the preview monitor 14 prior to surgery. This significantly reduces preoperative preparation time. The positions of the first recess 108 and the second recess 110, as well as the marker 112, relative to the suture arm 58, the instrument channel lumen 88, and the needle exchange lumen 86, and the areas covered and obstructed by the field of view from the distal end of the endoscope, are based on the scanning analysis results of multiple distal ends of the endoscope.

[0093] refer to Figure 14 The resilient clamp 102 also includes a plurality of longitudinally displaced (proximal and distal) integrated hooks 120, 122. In one embodiment, precisely, two hooks are provided to the clamp. The hooks are preferably identified by a contrasting color relative to the area surrounding the end cap and relative to most of the cap assembly. The hooks 120, 122 may also be marked with numbers, such as “1” and “2”, depending on the intended order of use, as described further below.

[0094] Turn Figure 15The system also includes a tape applicator 124 for applying tape to each of the hooks 120, 122. The tape applicator 124 includes a handle 126 and a spool 128 of tape 129 at the distal end of the handle. The illustrated embodiment of the handle 126 is preferably integral, thus including a wider proximal end 126p for stable grip in the user's hand, and a narrower extension 130 for uninterrupted access to the distal end 44 of the endoscope 12 and the vicinity of the cap assembly 50 during tape application. The extension 130 includes a spool mount 132. In a preferred embodiment, the spool mount 132 is externally threaded. The spool 128 is rotatably secured to the spool mount 132 of the handle 126 during use. The reel 128 includes an internal thread (not shown) that allows the reel to rotate onto the reel mount 132 in a rotational direction opposite to the intended application of the tape, such that when tension is applied to the tape, the reel is pulled in a direction that rotationally secures the reel relative to the mount. Other securing interfaces between the mount and the reel may be used. The tape preferably has a non-adhesive free end 134 provided with an integral ring 136, which is reinforced and sized for attachment to one of the hooks 120, 122. The reinforced integral ring 136 is preferably provided in a certain color to facilitate its positioning in an operating room environment. By way of example, the ring 136 is preferably opaque; and the ring is preferably matched in color to the hook on the cap assembly. Both may be opaque white. In one embodiment, the ring 136 has a diameter of approximately 2.5 mm. The diameter of the reel 128 is preferably smaller than that of the endoscope 12 to provide mechanical advantages when the tape 129 is wound to secure the clamp 102 and the endoscope 12 to each other. In one embodiment, the reel has a diameter of 10 mm and a tape width of 5 mm. In one embodiment, except for the free end 134, the tape 129 has a constant adhesive force along its length and is primarily adapted to adhere to its own back side under tension, as well as to both the endoscope 12 and the clamp 102. Alternatively, the tape 129 may have a non-adhesive first portion for initially winding the endoscope and a second adhesive portion for winding and adhering to the back side of the first portion and the back side of the second portion.

[0095] Now turning Figure 16 , Figure 17 and Figure 18The tape system also provides for securing a portion of the sheath relative to the endoscope. The sheath 89 is provided with a plurality of tapes 140 pre-set along its length. In a preferred embodiment, three tapes are used: a first tape 140a, a second tape 140b, and a third tape 140c; the first tape 140a is located at the distal end of the sheath; the second tape 140b is located approximately at the center along the length of the sheath; and the third tape 140c is located between the first tape 140a and the second tape 140b, and preferably closer to the first tape 140a. This limited use and specific spacing of the tapes has been shown to provide good stability of the sheath relative to the endoscope during use. That is, additional strips of tape can be pre-provided to the sheath and can be used in the manner described. According to one aspect of the system, multiple strips of tape 140 have an adhesive first portion 141, a second portion 142, and a third portion 144; the adhesive first portion 141 is pre-applied to a sheath 89; the second portion 142 is adjacent to a sheath recess 96, which is non-adhesive to prevent adhesion to the endoscope as the tape is wrapped around it; the third portion 144 extends from the second portion 142 and extends to a free end 146 of the tape strip, which is adhesive and adapted to adhere to the back side of the tape when the endoscope 12 and the sheath 89 are wrapped around it. According to another aspect, each strip of tape 140 includes a tear-off protective strip 148 covering the second portion 144. The tear-off protective strip 148 extends to cover the third portion 144 of the tape and is bent into an L-shaped extension tab between the free end 146 and the first portion 141. The tab 148 is preferably a highly visible color (e.g., white) compared to the sheath, and also preferably includes markings (e.g., laser-cut arrows 150) indicating which direction the tab 148 of the protective strip should be pulled to release the protective strip from the third part, thereby exposing the adhesive. Figure 17 According to one aspect of the system, strip 140 has at least one perforation 152, which allows for disassembly and removal after use of the system. Figure 18 The perforation 152 is preferably provided at or near the junction of the second part 142 and the third part 144 of the tape.

[0096] Turn Figure 8 , Figure 19 and Figure 20 According to another aspect of the system, the cap assembly 50 is adapted to be folded back relative to the sheath 89 via an actuation of the proximal handle 24. The aforementioned cable 100 extends from the proximal handle 24, passes through a lumen 94 in the sheath 89, and exits from the distal end of the sheath. Cable 100 as used herein refers to a textile, polymer, or metal monofilament, multifilament, or stranded cable element. A gap 154 ​​exists between the distal end of the sheath and the end cap. Figure 8This exposes a certain length of catheters 34, 36, transfer assembly 42, and cable 100 outside the sheath 89 and to the cap assembly 50. The length of gap 154 ​​generally represents the length difference between endoscope 12 and sheath 89; endoscope 12 has a longer first length, and sheath 89 has a shorter second length. In a preferred embodiment, the exposed length of gap 154 ​​is less than 16 cm; more preferably, the length of gap is between 6 cm and 12 cm; even more preferably, the length of gap is between 7.5 cm and 10 cm; and most preferably, the exposed length of gap is 8.5 cm to provide optimal folding, as described below. The transfer assembly 42 on the opposite side of gap 154 ​​is secured in the side recess 85 of cap assembly 50, and catheters 34, 36 are secured within the first through hole 86 and the second through hole 88 (e.g., as described below). Figure 9 (As shown). Additionally, the distal end 156 of the cable 100 is secured to the cap assembly 50. In one assembly, the distal end 156 is bonded to a hole (not shown) at the proximal end of the cap assembly 50. The proximal end 158 of the cable 100 exits from the sheath and through an opening in the proximal handle 24, and is attached to the pull handle 160. A pull handle mounting member 162 is preferably formed on the proximal handle 24 and, when not in use, can be secured to the pull handle 160 via an interference fit. A cable locking member 164 is provided on the proximal handle 24 to secure the cable in a tensioned state. An exemplary embodiment of the cable locking member 164 includes an elastic rubber washer 166 fixed to the base 168 and the post 170 (…). Figure 21 In use, when it is desired to fold the cap assembly 50 back, the pull handle 160 can be released from the handle mount 162 and pulled to apply tension to the cable 100. As tension is applied to the cable 100, the cable 100 retracts across the gap 154 ​​and retracts through the lumen 94. As the cable 100 is pulled across the gap 154, the cap assembly 150 folds back to shorten the distance between the end of the sheath 89 and the position where the distal end 156 of the cable is attached to the cap assembly 50, as... Figure 22 As shown. When the desired degree of retraction is achieved, the tension on the cable 100 can be temporarily maintained (and the retraction configuration is fixed) by wrapping the proximal end 158 of the cable 100 around the post 170 between the washer 166 and the base 168. Figure 23 The compression of the cable 100 between the washer 166 and the base 168 holds the cable in place. The pull handle 160 can be returned to the handle mount 162 to avoid obstructing operation (i.e., return to...). Figure 19(as shown in the diagram), while utilizing other features of the proximal stem 24 and endoscope 12. The system's folding can be used in conjunction with the actuated folding of the endoscope. Then, when intended to release the folded state at the distal end, the proximal end 158 of the cable 100 disengages from the cable lock 164, releasing the tension on the cable. In this way, the system's folding assists the operation of the system attached to the endoscope and ensures that the endoscope's folding is performed exactly as intended. It is also recognized that this type of folding system (with or without the assistance of an endoscope) can be used in various endoscopic treatment and intervention systems and is not limited to systems used for suturing.

[0097] Based on the above, the suturing device can be prepared for use with an endoscope as follows: The distal end 44 of the endoscope 12 is pushed into the elastic clamp 104 until it abuts against or approaches the distal stop 106. Figure 10 Then, the endoscope and cap assembly 50 are rotated coaxially relative to each other until the instrument channel 13 of the endoscope is rotatably aligned with the mark 112 at the distal stop 106 to ensure proper alignment between the two. Figure 12 and Figure 13 Then, if necessary, the endoscope 12 is always pushed to contact the distal stop 106. Figure 14 ).

[0098] Then, refer to Figure 24 , Figure 25 and Figure 26 A loop 136 at the free end 134 of the first reel 128 of the tape applicator 124 engages with the distal first hook 120; and a handle 126 connected to the reel 128 is manipulated to wrap tape 129 around the distal portion 44 of the distal end of the endoscope 12, around the clamp 102, and return to the back of the tape 129 in a circular motion (arrow 138) one or more times to secure the endoscope relative to the clamp. Tension is applied to the tape during wrapping. The relative diameters of the tape reel 128 and the endoscope 12 facilitate applying significant tension to the tape during tape wrapping of the endoscope. After the tape is applied to the first hook 120, the exhausted reel 128 is removed from the reel mount 132, and a new reel 128 of tape is attached to the reel mount of the handle 126. Reference Figure 27 and Figure 28 Similarly, the tape 129 of the new reel 128 is applied from the second hook 122 and applied to the adjacent area of ​​the endoscope 12 until the distal end 44 of the endoscope 12 and the cap assembly 50 are secured together.

[0099] Then, turn Figure 11 , Figure 17 , Figure 18 and Figure 29The endoscope is pressed completely into the recess 96 along the length of the sheath 89. Starting from the distal end of the system, and at the tape strip 140a, the tabs 148 of the protective strip are torn off to expose the adhesive portion 144. The tape 140 is pulled taut, the first portion 142 of the tape is wrapped around the endoscope 12, and the second adhesive portion 144 of the tape adheres to the sheath on the opposite side of the recess 96, and then extends again along the tape to secure the endoscope there. This process is repeated for the remaining strips 140c and then strips 140b along the length of the sheath to properly secure the sheath relative to the endoscope. This operation longitudinally secures the sheath 89 to the outside of the endoscope 12 for intra-body manipulation.

[0100] The collar 28 is suitably located at the proximal handle 45 of the endoscope 12. A first device (needle-catching instrument 38 with needle assembly 70) is advanced through the first port 32, into the first lumen 34, and into the cap assembly 50. A suitable needle-catching device 38 is described in detail in U.S. Patent 8,679,136, which is incorporated herein by reference in its entirety for all purposes. The needle assembly 70 is mounted on the needle arm 58, wherein the suture 78 extends parallel to the needle-catching instrument 38 within the first lumen 34.

[0101] refer to Figure 1 and Figure 25 The distal end of endoscope 12 and the cap assembly 50 of suture device 22 are optionally advanced through a guide tube (not shown) into the patient's natural orifice and approach the target tissue 180. If at any time it is necessary to reorient endoscope 12 via folding, the cap assembly 50 may also be folded back (as described above) to assist and / or further guide the distal end of endoscope and cap assembly to the intended target tissue. Once adjacent to the target tissue 180, the handle 24 of suture device 22 is operated to move the needle arm 58 to the open position, as... Figure 29 As shown. Turning Figure 31 The end actuator of the second device (e.g., a tissue retractor 40 having a helical coil 40a at its distal end) is advanced through the second port 32 and into the second catheter 36. Figure 8 ), push out of the second through hole 88 ( Figure 9 The tissue retractor is then advanced beyond the cap assembly 50. A suitable tissue retractor is described in detail in U.S. Patent 11,083,364, which is incorporated herein by reference in its entirety for all purposes. Other tissue retractors, including forceps, may also be used. The helical coil 40a operates to engage the target tissue 180. The tissue retractor 40 is withdrawn to pull the tissue 180 against the tissue guard 87 and draw it into a tissue fold 182; the tissue fold 182 is located within the path of the needle assembly 70, i.e., between the support 54 and the needle guide 87, such as... Figure 32As shown. The orientation of the second through hole 88 (at an angle relative to the first through hole 86, either parallel or oblique) is adapted to guide the tissue retractor to engage the tissue and retract the tissue into the needle path. Then, the shank 24 is operated to move the needle arm 58 to the closed position, thereby piercing the tissue fold 182 during the movement and allowing the needle assembly 70 and suture 78 to pass through the tissue fold ( Figure 33 When the needle arm 58 is in the closed position, the needle is received in the distal end of the needle capturing device 38. Figure 9 The needle capturing device 38 operates to securely engage the needle 70. Then, the shank 24 operates to move the needle arm 58 toward the open position, thereby disengaging the needle arm 58 from the needle assembly 70, which remains in the needle capturing device 38. Figure 34 The tissue retractor 40 is also released from the tissue and withdrawn through the second catheter 36. The endoscope 12 is then moved to displace the cap assembly 50 relative to the sutured tissue 184. The needle 70 and suture 78 may be secured to the tissue, such as by knotting or tightening; or the needle may be repositioned on the needle arm; and additional suture loops may be formed in adjacent areas or other areas of the tissue. Once suturing is complete, the needle arm 58 returns to the closed position, and the endoscope 12 and suture device 22 are removed from the patient.

[0102] Then, by cutting (e.g., with scissors 190) the two adhesive tapes 129 attached to the hooks 120, 122 (which secure the endoscope 12 relative to the cap assembly 50), and then untying the tapes 129 on the opening of the cap clamp 102, the suture assembly is released from the endoscope, as if by... Figure 30 and Figure 31 As shown in both. Then, refer to... Figure 37 By applying force in the direction of arrow 174, each corresponding tape segment is made to have its perforation 152 ( Figure 18 The tape strips 140b, 140c, and 140a break sequentially at point 140. Because each tape strip is not directly bonded to the endoscope, but only to itself and the sheath 89, the endoscope can be released once the tape strip breaks. Then, the proximal handle 24 is completely released from the endoscope 12.

[0103] Based on the foregoing and according to the various principles of this disclosure, exemplary embodiments of an endoscopic device for use with an endoscope have a proximal handle assembly, a distal cap assembly, and a central portion adapted to extend along the endoscope between the handle assembly and the cap assembly. In some aspects, the handle assembly defines a recess in which the distal end of the endoscope is received. In some embodiments, the handle includes at least one hook on one side of the recess for receiving a tension member that wraps around the cap assembly and a portion of the endoscope.

[0104] In some embodiments, at least one hook is identified by a contrasting color relative to the majority of the cap assembly.

[0105] Additionally or alternatively, in some embodiments, the distal cap assembly includes a distal stop, the distal end of which is intended to abut. In some embodiments, the distal stop includes a marking, the endoscope being rotatably aligned relative to the marking. In some embodiments, the marking includes a contrasting color relative to most of the cap assembly. In some embodiments, the markings on the distal stop and at least one hook are identified by a common color. In some embodiments, the marking aligns with an endoscope characterized by the instrument channel of that endoscope.

[0106] Additionally or alternatively, in some embodiments, the cap assembly is a suture assembly that includes a movably mounted needle retainer. In some aspects, operation of the proximal shank assembly moves the needle retainer on the cap assembly.

[0107] According to various principles of this disclosure, exemplary embodiments of an endoscopic device for use with an endoscope include a proximal handle assembly, a distal cap assembly, and a central portion adapted to extend along the endoscope between the handle assembly and the cap assembly. In some aspects, the cap assembly defines a recess in which the distal end of the endoscope is received. Additionally or alternatively, the cap assembly includes two longitudinally spaced hooks on one side of the recess.

[0108] Additionally or alternatively, in some embodiments, each hook is identified by a contrasting color relative to the color of the majority of the cap assembly.

[0109] Additionally or alternatively, in some embodiments, each hook is identified by a different hook marking. In some embodiments, the hook markings indicate the order of operation of the hooks intended for use. In some embodiments, the hook markings include numbers.

[0110] Additionally or alternatively, in some embodiments, the distal cap assembly includes a resilient clamp that defines a recess.

[0111] Additionally or alternatively, in some embodiments, the distal cap assembly includes a distal stop intended to abut the distal end of the endoscope, the stop including contrast alignment marks relative to endoscope features intended for rotational alignment.

[0112] Additionally or alternatively, in some embodiments, the distal cap assembly includes a distal stop intended to abut the distal end of the endoscope, the stop including a contrast alignment mark relative to the instrument channel of the endoscope intended for rotational alignment. In some embodiments, the distal stop includes a first recess and a second recess, and the alignment mark is disposed at the first recess.

[0113] In some embodiments, the cap assembly is a suture assembly that includes a movably mounted needle retainer; and operation of the proximal shank assembly moves the needle retainer on the cap assembly.

[0114] According to various principles of this disclosure, exemplary embodiments of a fixation system for use with an endoscope include an endoscope device and a tape reel; the endoscope device includes a proximal handle assembly, a distal cap assembly, and a central portion adapted to extend along the endoscope between the handle assembly and the cap assembly. In some embodiments, the distal cap assembly defines a recess and hooks on the sides of the recess, in which a distal end of the endoscope is received. In some embodiments, the tape reel has a free end provided with a pre-formed loop adapted to be received on the hook. In some embodiments, the loop is adapted to attach to the hook. In some embodiments, the tape is adapted to wrap around the cap assembly and a portion of the endoscope to connect the cap assembly and the endoscope to each other.

[0115] In some embodiments, the system further includes a tape applicator comprising a shank and an extension having a reel mount. In some embodiments, the reel is coupled to the reel mount. In some embodiments, the reel is removably coupled to the reel mount.

[0116] In some embodiments, the cap assembly includes at least two longitudinally spaced hooks. In some embodiments, the fastening system includes at least two tape reels.

[0117] In some embodiments, the hook is identified by a contrasting color relative to the color of most of the cap assembly.

[0118] In some embodiments, the cap assembly includes at least two hooks. In some embodiments, each hook is identified by a different hook marking. In some embodiments, the hook marking identifies the order of operation of the hooks intended for use. In some embodiments, the hook marking includes a contrasting color relative to the majority of the cap assembly.

[0119] In some embodiments, the cap assembly is a suture assembly that includes a movably mounted needle retainer. In some embodiments, operation of the proximal shank assembly moves the needle retainer on the cap assembly.

[0120] According to various principles of this disclosure, a method includes attaching a cap assembly of an endoscope to an endoscope having a distal end. In some aspects, the cap assembly defines a recess in which the distal end of the endoscope is received. Additionally or alternatively, the cap assembly has first and second longitudinally spaced hooks on one side of the recess. According to various principles of this disclosure, the method includes: inserting the distal end of the endoscope into the recess; providing a first length of adhesive tape having a first loop at a free end; attaching the first loop to the first hook; and wrapping at least a portion of the first length of adhesive tape around the distal end of the endoscope and the cap assembly.

[0121] In some aspects, the method further includes: providing a second length of adhesive tape having a second loop at a free end; engaging the second loop to a second hook; and wrapping at least a portion of the second length of adhesive tape around a distal end of the endoscope and a cap assembly. In some aspects, a first hook is displaced distally from a second hook. In some aspects, the endoscopic device includes a proximal handle and a central longitudinal sheath portion extending between the handle and the cap assembly. In some aspects, the central longitudinal sheath portion includes a concave recess along its length. In some aspects, the method further includes: inserting an endoscope into the recess of the central longitudinal sheath portion; and securing the central longitudinal sheath portion to the endoscope. In some aspects, the sheath portion is secured to the endoscope with a plurality of longitudinally spaced adhesive tape pieces positioned at least partially circumferentially around the sheath portion and the endoscope. In some aspects, the central longitudinal sheath portion is crescent-shaped and defines at least one lumen. In some aspects, at least one lumen includes a first lumen and a second lumen; a flexible first catheter extends through the first lumen to a cap assembly; a flexible second catheter extends through the second lumen to the cap assembly. In some aspects, the cap assembly includes an actuating arm movably mounted thereon. In some aspects, a central longitudinal sheath portion includes a third lumen through which the actuating assembly extends. In some aspects, the actuating assembly is coupled between a proximal stem and an actuating arm and is adapted to move the actuating arm on the cap assembly when the proximal stem is operated. In some aspects, the endoscopic device includes a cable having a proximal end and a distal end; the cable extends from the proximal stem, extends through the central longitudinal sheath portion, and is secured to the cap assembly. In some aspects, the proximal end of the cable retracts relative to the proximal stem, and the distal end of the cable is tensioned to cause the first and second catheters to flex and pull the cap assembly in reverse.

[0122] In some respects, the cap assembly is a stitching assembly that includes a removably mounted needle retainer.

[0123] According to various principles of this disclosure, exemplary embodiments of an endoscopic device for use with an endoscope include a proximal handle assembly, a distal cap assembly, a sheath portion, and a fixation system. In some aspects, the cap assembly defines an assembly for positioning adjacent to a distal end of the endoscope. In some aspects, the sheath portion defines a longitudinal recess. In some aspects, the sheath portion is adapted to extend along the exterior of the endoscope between the handle assembly and the cap assembly. In some aspects, the sheath portion is adapted to extend at least partially around the endoscope in the recess. In some aspects, the recess has a first side and a second side. In some aspects, the fixation system is configured to secure a central portion to the exterior of the endoscope during intra-endoscopic manipulation. In some aspects, the fixation system includes a plurality of longitudinally spaced adhesive tape segments pre-applied to the sheath portion on the first side of the recess. In some aspects, at least some or each of the tape segments has an adhesive first portion and a non-adhesive second portion, the adhesive first portion being bonded to a sheath on a first side of the recess, the non-adhesive second portion extending from the first portion. In some aspects, at least some or each of the tape segments has an adhesive third portion, the adhesive third portion extending from the second portion and terminating at a free end.

[0124] In some aspects, the fastening system also includes a removable non-adhesive protective strip on the third part.

[0125] In some respects, the protective strip extends into a tab with a free end that protrudes between the free end and the first portion.

[0126] Alternatively or additionally, the protective strip extends into the L-shaped non-adhesive tab. Alternatively or additionally, the tab has markings indicating the direction in which the tab should be pulled to expose the third part.

[0127] Alternatively, the protective strip may have a contrasting color to the sheath portion.

[0128] In some respects, each tape segment has a perforation between the second and third portions of the tape, at or near the junction of the two portions.

[0129] In some aspects, the fastening system includes a first tape segment, a second tape segment, and a third tape segment; the first tape segment is pre-applied to the distal end of the sheath portion, the second tape segment is pre-applied to the central portion of the sheath portion, and the third tape segment is pre-applied to the sheath portion between the first and second tape segments.

[0130] In some respects, the sheath portion defines at least one lumen within its wall.

[0131] In some aspects, the cap assembly is a suture assembly that includes a movably mounted needle retainer. In other aspects, operation of the proximal shank assembly moves the needle retainer on the cap assembly.

[0132] According to various principles of this disclosure, a method of securing an endoscopic device to an endoscope includes securing an endoscope having an outer sheath to the endoscope. In some aspects, the endoscope has a circumference and a first length; and the sheath has a second length configured to extend along at least a portion of the first length of the endoscope around at least a portion of the endoscope's circumference. In some aspects, the method includes: providing a pre-applied portion of tape to the sheath along the second length; extending the sheath along the first length around a portion of the endoscope's circumference; and wrapping the pre-applied portion of tape around the periphery of the endoscope and the sheath to secure the sheath to the endoscope.

[0133] In some aspects, at least one or each pre-applied portion of the tape includes an adhesive first portion, at which a portion of the tape is adhered to the sheath. Additionally or alternatively, at least one or each pre-applied portion of the tape includes a non-adhesive second portion extending from the first portion. Additionally or alternatively, at least one or each pre-applied portion of the tape includes an adhesive third portion extending from the second portion and terminating at a free end. Additionally or alternatively, at least one or each pre-applied portion of the tape includes a removable protective strip on the third portion. In some aspects, the method further includes: removing the removable protective strip from the third portion, causing the second portion to extend into contact with the endoscope, and adhering the third portion to the endoscope on the opposite side relative to the first portion to contact the sheath.

[0134] In some respects, the sheath defines a recess into which the endoscope is inserted, and the first and third portions of the tape are located on opposite sides of the recess.

[0135] In some aspects, each pre-applied portion of the tape includes a perforation. In some aspects, the method further includes releasing the endoscope from the sheath by applying force to break the tape at the perforation. In some aspects, the tape breaks without being cut. In some aspects, the tape breaks by applying a force parallel to the longitudinal axis of the endoscope. In some aspects, the cap assembly is a suture assembly that includes a movably mounted needle retainer.

[0136] According to various principles of this disclosure, exemplary embodiments of an endoscopic device for use with an endoscope include a proximal handle assembly, a distal cap assembly, a sheath, a first conduit, a second conduit, and a transmission cable. In some aspects, the distal cap assembly is adapted to be positioned adjacent to the distal end of the endoscope. In some aspects, the cap assembly has an end effector movable thereon. In some aspects, the sheath is a crescent-shaped flexible sheath. Additionally or alternatively, the sheath has a longitudinally lateral opening recess sized to receive a portion of the endoscope between the handle assembly and the cap assembly. Additionally or alternatively, the sheath defines a first lumen, a second lumen, and a third lumen. In some aspects, the first conduit extends in the first lumen and extends distally beyond the first lumen to the cap assembly. In some aspects, the second conduit extends in the second lumen and extends distally beyond the second lumen to the cap assembly. In some aspects, the transmission cable extends from the handle assembly. In some aspects, the transmission cable extends from the handle assembly into the third lumen. In some aspects, the transmission assembly extends distally beyond the third lumen to the cap assembly. In some aspects, the transmission assembly is operatively coupled to the end effector. In some aspects, operation of the handle assembly moves the transmission cable to operate the end effector.

[0137] In some respects, the cap assembly is a stitching assembly, and the end effector is a needle retainer.

[0138] According to various principles of this disclosure, exemplary embodiments of an endoscopic device are configured for use with an endoscope having a proximal and distal end, an instrument channel, and a lens. According to various principles of this disclosure, the endoscopic device includes a proximal handle, a distal cap assembly, and a central portion extending between the handle and the cap assembly. In some aspects, the distal cap assembly defines components for interaction with tissue. In some aspects, the distal cap assembly is adapted to be positioned adjacent to the distal end of the endoscope. In some aspects, the distal cap assembly includes a clamp for receiving the distal end of the endoscope. In some aspects, the distal cap assembly includes a stop to limit the distal travel of the endoscope. In some aspects, the stop has a mark to which features of the endoscope are rotately aligned to ensure proper orientation of the lens and instrument channel of the endoscope without obstruction. In some aspects, the central portion extends between the handle and the cap assembly.

[0139] In some respects, the stop is suitable for use with endoscopes from multiple manufacturers.

[0140] In some aspects, the cap assembly is a suture assembly that includes a movably mounted needle retainer. In some aspects, operation of the proximal shank causes the needle retainer to move on the cap assembly.

[0141] According to various principles of this disclosure, exemplary embodiments of an endoscopic device for use with an endoscope include a proximal handle assembly, a distal cap assembly, a sheath, at least one catheter, and a cable. In some aspects, the distal cap assembly is adapted to be coupled to a distal end of the endoscope, the distal end being spaced apart from the handle assembly by a first length. In some aspects, the sheath is a flexible sheath. In some aspects, the sheath has a proximal end and a distal end, the proximal end being attached to the handle assembly. In some aspects, the sheath extends a second length less than the first length. In some aspects, the difference between the first length and the second length defines a gap. In some aspects, the sheath is adapted to extend at least partially around the exterior of the endoscope. In some aspects, the sheath defines at least one lumen. In some aspects, at least one catheter extends from the proximal end of the sheath through at least one lumen. In some aspects, at least one catheter extends beyond the distal end of the sheath. In some aspects, at least one catheter is secured to the cap assembly. In some aspects, the cable has a proximal end and a distal end. In some aspects, the cable extends from the proximal end of the sheath, extends through at least one lumen, and extends away from the distal end of the sheath. In some aspects, the distal end of the cable is secured to the cap assembly. In some aspects, the proximal end of the cable extends from an opening in the handle assembly. In some aspects, when the proximal end of the cable retracts relative to the handle, the distal end of the cable tensions to cause the conduit to flex and pull the cap assembly across the gap in a reverse fold.

[0142] In some aspects, the distal cap assembly is a suture assembly including a needle movable relative to at least one catheter. In some aspects, a cable extends through a common lumen along with a transmission cable for operating the suture assembly.

[0143] In some aspects, the device includes a pull handle that is attached to the proximal end of the cable. In some aspects, the proximal handle assembly is adapted to releasably house the pull handle.

[0144] In some aspects, the device also includes a locking system to temporarily hold the cable under tension. In some aspects, the proximal shank assembly includes a locking system. In some aspects, the locking system includes a post and a washer, the post having a base and the washer disposed on the post on the base. In some aspects, the proximal end of the cable is held in place on the post. In some aspects, the proximal end of the cable is held in place on the post when the post is wound between the base and the washer. In some aspects, the washer is made of an elastic material.

[0145] According to various principles of this disclosure, exemplary embodiments of an endoscope system include an endoscope and an external instrument access device connectable to the endoscope. In some aspects, the endoscope has a proximal end and a distal end, and an outer surface extending between the proximal and distal ends. In some aspects, the proximal end has a first handle. In some aspects, the distal end is adapted to fold back upon actuation of the proximal end. In some aspects, the instrument access device has a second handle. In some aspects, the instrument access device has a sheath adapted to be coupled to the outer surface of the endoscope immediately adjacent to the proximal and distal ends. In some aspects, the instrument access device has a cap removably coupled to the distal end of the endoscope. In some aspects, the instrument access device has an instrument channel extending from the distal end of the sheath to the cap. In some aspects, the instrument access device has a pull cable extending from the second handle, through the sheath, and fixed relative to the cap. In some respects, when the cable is under tension, the cap is offset to a reversed position around the instrument channel.

[0146] In some respects, the cap is part of the sewing assembly.

[0147] In some aspects, the system also includes a traction handle attached to the proximal end of the cable. In some aspects, the external instrument access device includes a proximal handle assembly. In some aspects, the proximal handle assembly is adapted to releasably receive the traction handle.

[0148] In some aspects, the system also includes a locking system to temporarily hold the cable under tension. In some aspects, the external instrument access device includes a proximal handle assembly, and this proximal handle assembly is provided with a locking system. In some aspects, the locking system includes a column and a washer, the column having a base, the washer being disposed on the column on the base. In some aspects, the proximal end of the cable is held in place on the column. In some aspects, the proximal end of the cable is held in place on the column when the column is wound between the base and the washer.

[0149] The suturing assembly described above is suitable for use with an endoscope that does not necessarily have at least two instrument channels. Therefore, the suturing system can be used with smaller endoscopes that are available in many surgical scenarios and can be more easily advanced through natural orifices. Furthermore, as indicated, several aspects of the system can be used in surgical treatment scenarios other than suturing.

[0150] This document has described and illustrated embodiments of suturing systems and surgical treatment systems, as well as methods of using them. While specific embodiments of the invention have been described, it is not intended to limit the invention thereto, but rather it is intended that the invention have a broad scope that will be permitted in the art, and the description is intended to be understood in the same way. Therefore, although specific instruments and devices for advancing through first and second lumens have been disclosed, it should be understood that other instruments passing through such lumens may also be used for the same or even different purposes. Furthermore, while the treatment system has been specifically described with respect to a cap assembly having an end effector in the form of a needle arm (which carries the needle), it should be understood that alternatively, one or more movable end effectors with other structures and uses may be provided to the cap assembly. Additionally, while tissue anchors in the form of needle assemblies have been described, the end effectors may deploy different types of tissue anchors, including, for example, clamps. Furthermore, while specific needle assemblies have been described, other needle assemblies may be used similarly. Furthermore, the size and instrument channel characteristics of the endoscope used with the system are non-critical; it should be understood that various prior art systems are not suitable for suturing operations when combined with endoscopes having fewer than two instrument channels (one for receiving a needle exchange device and the other for receiving a tissue retractor), while the system of the present invention can accomplish the operation without providing any channel through the endoscope. Moreover, although it is indicated that the various features described herein (such as the folding system) are not limited to suturing applications, it is expressly understood that the folding system can be used in conjunction with a cap assembly adapted to provide a variety of other surgical applications, including but not limited to staplers, clamps, ligators, tissue manipulation instruments, cutting instruments, forceps, biopsy instruments, injection devices, and cap assemblies that do not have a significant function other than supporting external catheters (for instrument passage). Therefore, those skilled in the art will understand that other modifications can be made to the invention without departing from its claimed scope.

[0151] Those skilled in the art will understand that this discussion is merely a description of illustrative examples and is not intended to limit the broader scope of this disclosure.

[0152] All devices and methods discussed herein are examples of devices and / or methods implemented according to one or more principles of this disclosure. These examples are not the only ways to implement these principles, but are merely examples and are not intended to limit the broader aspects of this disclosure. Therefore, references to elements or structures or features in the accompanying drawings should be understood as references to exemplary embodiments of this disclosure and should not be construed as limiting this disclosure to the specific elements, structures, or features shown. Upon reading this disclosure, those skilled in the art will recall other examples of ways to implement the disclosed principles. It will be apparent to those skilled in the art that variations may be applied to the disclosed apparatus, systems, and / or methods, and / or to the sequence of steps of the methods described herein, without departing from the concept, spirit, and scope of this disclosure. It should be understood that various features described with respect to one embodiment are generally applicable to another embodiment, whether or not explicitly indicated. The various features described below may be used individually or in any combination thereof. Therefore, the invention is not limited to the embodiments specifically described herein; and all such alternatives and modifications that are apparent to those skilled in the art are considered to be within the spirit, scope, and concept of this disclosure as defined by the appended claims. In addition to those discussed above, those skilled in the art will understand various other benefits of the aspects, features, components, and structures of the devices and systems described above.

[0153] The foregoing discussion has broad application and has been presented for illustrative and descriptive purposes, and is not intended to limit this disclosure to the one or more forms disclosed herein. It should be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the spirit, scope, and intent of this disclosure. In particular, it will be apparent to those skilled in the art that the principles of this disclosure can be implemented in other forms, structures, arrangements, proportions, with other elements, materials, and components without departing from its spirit, scope, or characteristics. For example, for the purpose of simplifying the disclosure, various features of this disclosure are grouped by one or more aspects, embodiments, or configurations. However, it should be understood that various features of certain aspects, embodiments, or configurations of this disclosure can be combined in alternative aspects, embodiments, or configurations. Although this disclosure is presented in the form of embodiments, it should be understood that various independent features of the subject matter of the invention need not always be present to achieve at least some of the desired characteristics and / or benefits of the subject matter of the invention or such independent features. Those skilled in the art will understand that this disclosure can be used with numerous modifications to the structure, arrangement, proportions, materials, components, etc., used in practicing this disclosure, modifications particularly suited to specific environments and operational requirements without departing from the principles, spirit, or scope of this disclosure. For example, an element shown as integrally formed may be composed of multiple parts, or an element shown as multiple parts may be integrally formed; the operation of the element may be reversed or otherwise altered; the size or dimensions of the element may be changed. Similarly, although operations or actions or procedures are described in a particular order, this should not be construed as requiring such a particular order, or requiring all operations or actions or steps to be performed to achieve the desired result. Furthermore, other embodiments may fall within the scope of the following claims. In some cases, the actions recited in the claims may be performed in a different order and still achieve the desired result. Therefore, the embodiments disclosed herein should be considered illustrative and non-limiting in all respects, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing descriptions or specific embodiments or arrangements described or shown herein. Based on the foregoing, any independent feature of any embodiment may be used and may be claimed individually or in combination with features of that embodiment or any other embodiment; the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0154] The following will be understood in the foregoing description and the following claims. As used herein, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are both connecting and transitional in operation. The terms “a,” “an,” “the,” “first,” “second,” etc., do not exclude plurals. For example, as used herein, the term “a” or “an” entity refers to one or more of that entity. Thus, the terms “a” (or “an”), “one or more,” and “at least one” may be used interchangeably herein. As used herein and in the appended claims, the term “or” is generally used in its meaning as including “and / or” unless the context clearly indicates otherwise. As used herein, the conjunction “and” includes each of such combined structures, components, features, etc., unless the context clearly indicates otherwise; and the conjunction “or” individually and in any combination and number includes one or the other of such combined structures, components, features, etc., unless the context clearly indicates otherwise. All directional references (e.g., proximal, distal, up, down, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used solely for identification purposes to assist the reader in understanding this disclosure, and / or to distinguish areas of related elements from one another, and in particular do not limit the related elements to the location, orientation, or purpose of this disclosure. Connecting references (e.g., attachment, connection, joint, join, link, etc.) should be interpreted broadly and may include intermediate members between sets of elements and relative movement between elements, unless otherwise specified. Therefore, connecting references do not necessarily imply that two elements are directly connected and in a fixed relationship with each other. Identifying references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish features from one another.

[0155] The following claims are hereby incorporated by reference into the detailed description, wherein each claim is itself a separate embodiment of this disclosure. In the claims, the terms “comprises,” “comprising,” “includes,” and “including” do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. Furthermore, while independent features may be included in different claims, these features may be advantageously combined, and inclusion in different claims does not imply that the combination of features is infeasible and / or unadvantageous. Moreover, singular references do not exclude plural references. Reference marks in the claims are provided only as clarifying examples and should not be construed as limiting the scope of the claims in any way.

Claims

1. A flexible tubular elongated member for use with a deflection system, the flexible tubular elongated member comprising: An outer surface and an inner surface, the outer surface and the inner surface extending between a proximal end and a distal end of the flexible tubular elongated member, the inner surface defining one or more lumens through the flexible tubular elongated member between the proximal end and the distal end of the flexible tubular elongated member; and A flexural segment, the flexural segment extending along the length of the flexible tubular elongated member between the proximal end and the distal end, the flexural segment being configured to resist kinking and / or deformation; in: The shape, structure, and / or size of at least one of the outer surface or the inner surface of the flexural segment are configured to facilitate the flexural bending of the flexural segment.

2. The flexible tubular elongated member according to claim 1, wherein, At least one of the outer surface or the inner surface of the flexural section is corrugated.

3. The flexible tubular elongated member according to any one of claims 1 to 2, wherein, The flexural section is reinforced.

4. The flexible tubular elongated member according to any one of claims 1 to 3, wherein, The flexural section includes a wire coil between its outer surface and its inner surface, the wire coil reinforcing the flexural section.

5. The flexible tubular elongated member according to claim 4, wherein, The outer and inner surfaces of the flexural section are corrugated due to the shape of the wire coil therebetween.

6. The flexible tubular elongated member according to any one of claims 1 to 5, wherein, The flexural section includes a wire coil between its outer surface and inner surface to facilitate the flexural section's bending.

7. The flexible tubular elongated member according to any one of claims 1 to 6, wherein, The flexural section further includes an outer tubular core layer on the wire coil and an inner tubular core layer inside the wire coil, thereby forming a multi-layered wall of the flexural section.

8. The flexible tubular elongated member according to any one of claims 1 to 7, wherein, One or more wall regions of the flexural segment have alternating thick and thin wall thicknesses.

9. The flexible tubular elongated member according to any one of claims 1 to 8, wherein, As the flexural section flexes, the cross-sectional shape of the one or more lumens passing through the flexural section remains substantially the same.

10. The flexible tubular elongated member according to any one of claims 1 to 9, wherein, The flexural section extends along a portion of the distal end of the flexible tubular elongated member.

11. A system for reversing a flexible, elongated member of a medical device, the system comprising: An elongated actuating component, the elongated actuating component extending along the flexible elongated member and having a proximal end and a distal end; A distal mounting member configured to be mounted relative to the distal end of the flexible elongated member; A pivot mount, the pivot mount being configured to be mounted proximal to the distal mount relative to the flexible elongated member; and An auxiliary flexible tubular elongated member, the auxiliary flexible tubular elongated member being configured to extend along the flexible elongated member and having a proximal end and a distal end; in: The distal end of the auxiliary flexible tubular elongated member is operatively associated with the distal mounting member; The distal end of the actuating member is operatively associated with the distal mount to cause flexure of the distal end of the flexible elongated member when the actuating member is pulled proximally. When the actuating component is pulled proximally to cause the flexible elongated member to fold back, the actuating region of the actuating component pivots relative to the pivoting mount. The auxiliary flexible tubular elongated member includes a flexural section operatively associated with the distal mount to flex when the actuating member is pulled proximally. The flexural section is configured to be kink-resistant and / or deformation-resistant when flexed; and One or more lumens define passages through the flexure section and have a cross-sectional shape that is unaffected and unchanged by the flexure of the flexure section.

12. The system of claim 11, further comprising a flexible tubular elongated member having a proximal end and a distal end, wherein a lumen extends between the proximal end and the distal end; in: The actuating component extends through the lumen of the flexible tubular elongated member; The flexible tubular elongated member is configured to be mounted relative to the flexible elongated member, wherein the distal end of the flexible tubular elongated member is proximal to the distal end of the flexible elongated member. The distal end of the flexible tubular elongated member forms the pivot mount for the actuating component; and The auxiliary flexible tubular elongated member extends along the flexible tubular elongated member, wherein the flexural segment extends distally beyond the distal end of the flexible tubular elongated member to be operatively associated with the distal mount.

13. The system according to any one of claims 12, wherein, The flexural section of the flexible tubular elongated member does not extend to the proximal end of the flexible tubular elongated member.

14. The system according to claim 12, wherein, The flexible tubular elongated member extends through a lumen defined by the flexible tubular elongated member.

15. The system according to any one of claims 11 to 14, wherein: The flexural section has an outer surface and an inner surface, the inner surface defining a lumen passing through the flexural section; and The shape, structure, and / or size of at least one of the outer surface or the inner surface of the flexural segment are configured to facilitate the flexural bending of the flexural segment.

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