Flexible tubular elongated members for medical applications, and related systems and methods.

Abstract

A kink-resistant and / or deformation-resistant flexible tubular elongated member can be inverted by more than 90°, for example, more than 180°, without kinking, deformation, distortion, ovalization, elongation, or any other change in shape, and / or otherwise without being functionally affected.

Description

Technical Field

[0001] The present disclosure relates to devices, systems, and methods for use during inversion of a medical device. More specifically, the present disclosure relates to devices and / or systems formed to be free from distortion during or by inversion of a medical device. Even more specifically, the present disclosure relates to a flexible tubular elongate member, which maintains the existence of a lumen extending therethrough during inversion. The flexible tubular elongate member can be configured to be attached to a medical device to be inverted.

Background Art

[0002] Various medical devices are designed to be inserted into a patient's body and to perform joint movements, bending, inversion, etc., within the patient's body. For example, one or more devices, instruments, tools, etc., can be advanced to a target site in the patient's body through one or more working channels of a medical scope (e.g., an endoscope). Such devices may also be known as through-the-scope ("TTS") devices. Some TTS devices may include one or more flexible tubular elongated members through which further components, devices, instruments, tools, etc., may extend through the medical scope. Incidentally or alternatively, over-the-scope ("OTS") endoscopic accessories may extend along the outer surface of the medical scope (and optionally be attached thereto). Various OTS devices can perform a variety of functions in cooperation with the associated medical scope and one or more TTS devices. Some OTS accessory devices may include one or more flexible tubular elongated members that define a lumen extending longitudinally through them. Lumens may function as auxiliary working channels, such as to accommodate working instruments and / or to allow one or more instruments to extend through the lumen, or to complement the working channels of a medical scope operatively associated with the lumen. Incidentally or alternatively, lumens may also allow fluids to pass through them to facilitate irrigation, suction, blowing, etc.

[0003] Various medical devices, including medical scopes, comprise one or more flexible elongated members and various mechanisms, such as internal pulleys and cables, for maneuvering (e.g., navigating and bending) the flexible elongated members through the patient's body (including meandering body passages). For example, several flexible elongated members may articulate in one or more planes for vertical and / or lateral movement, etc. Articulating devices and systems may be operated to direct the flexible elongated members towards a desired target site within the patient's body. In some cases, a high degree of flexion, such as to a point of inversion (backward bending), may be desired to access a target site within the patient's body. However, such inversion may present various challenges, such as with respect to the distortion of the lumen through the inversion member. It is with respect to these and other considerations that this improvement may be useful. [Overview of the project] [Means for solving the problem]

[0004] This summary is provided to introduce, in a simplified form, a selection of concepts that will be described in more detail in the following detailed description. This summary is not intended to necessarily identify any important or essential features of the claimed subject matter, nor is it intended to be an aid in determining the scope of the claimed subject matter. Those skilled in the art will understand that each of the various aspects and features of the disclosure may be used advantageously, in some cases separately, or in other cases in combination with other aspects and features of the disclosure, whether or not they are described in this summary. No limitation on the scope of the claimed subject matter is intended by the inclusion or exclusion of any elements, components, etc., in this summary.

[0005] A flexible tubular elongated member for use in a retroflexion system is disclosed in accordance with various principles of this disclosure. The flexible tubular elongated member includes an outer and inner surface extending between the proximal and distal ends of the flexible tubular elongated member, the inner surface defining one or more lumens passing through the flexible tubular elongated member between the proximal and distal ends, and a flexion section along the length of the flexible tubular elongated member between the proximal and distal ends, the flexion section configured to be kink-resistant and / or deformation-resistant. In some embodiments, at least one of the outer or inner surface of the flexion section is shaped, configured, and / or dimensional to facilitate the flexing of the flexion section.

[0006] In some embodiments, at least one of the outer or inner surfaces of the flexible section is corrugated. In some embodiments, the flexible section is reinforced. In some embodiments, the flexible section includes a wire coil between its outer and inner surfaces that reinforces the flexible section. In some embodiments, the outer and inner surfaces of the flexible section are corrugated as a result of the shape of the wire coil between them.

[0007] In some embodiments, the flexible section includes a wire coil between its outer and inner surfaces to facilitate the flexibility of the flexible section. In some embodiments, the flexible section further comprises an outer tubular core layer covering the wire coil and an inner tubular core layer within the wire core, thereby forming a multilayer wall of the flexible section.

[0008] In some embodiments, one or more wall regions of the deflection section have alternating thick and thin wall thicknesses. In some embodiments, the cross-sectional shape of one or more lumens passing through the flexible section remains substantially the same as the flexible section flexes.

[0009] In some embodiments, the flexible section extends along a portion of the distal end of a flexible tubular elongated member. A system for inverting a flexible elongated member of a medical device, according to various principles of the present disclosure, includes: an elongated actuation component extending along the flexible elongated member and having a proximal and distal end; a distal mount configured to be attached to the distal end of the flexible elongated member; a pivot mount configured to be attached to the flexible elongated member proximal to the distal mount; and an auxiliary flexible tubular elongated member extending along the flexible elongated member and having a proximal and distal end. In some embodiments, the distal end of an auxiliary flexible tubular elongated member is operatively associated with a distal mount, the distal end of an actuation component is operatively associated with the distal mount, and when the actuation component is pulled proximal, it causes the distal end of the flexible elongated member to flex, the actuation region of the actuation component pivots relative to a pivot mount when the actuation component is pulled proximal, and inverts the flexible elongated member, the auxiliary flexible tubular elongated member is operatively associated with the distal mount and includes a flex section that flexes when the actuation component is pulled proximal, 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 unchanged by the flexing of the flex section.

[0010] In some embodiments, the system further includes a flexible tubular elongated member having a proximal end and a distal end and a lumen extending between them. In some embodiments, the actuation component extends through the lumen of the flexible tubular elongated member, and the flexible tubular elongated member is configured to be attached to the flexible elongated member such that 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 forming a pivot mount for the actuation component, and the auxiliary flexible tubular elongated member extends along the flexible tubular elongated member with a flex section that extends distally beyond the distal end of the flexible tubular elongated member so as to be operatively associated with the distal mount. In some embodiments, the flex section of the flexible tubular elongated member does not extend to the proximal end of the flexible tubular elongated member. In some embodiments, the flexible tubular elongated member extends through a lumen defined within the flexible tubular elongated member.

[0011] In some embodiments, the deflection section has an outer surface and an inner surface, the inner surface defining a lumen through the deflection section, and at least one of the outer or inner surface of the deflection section is shaped, configured, and / or dimensional to facilitate the deflection of the deflection section.

[0012] In some embodiments, the flexible section is reinforced with a wire coil. A method for forming a kink-resistant and / or deformation-resistant flex section of a flexible tubular elongated member that can be inserted transtubally into a patient, according to various principles of the present disclosure, includes corrugating at least one of the outer or inner surfaces of the flex section to increase the flexibility of the flex section such that the cross-sectional shape of one or more lumens defined through the flex section is not changed or affected by the flexing of the flex section.

[0013] In some embodiments, the method further includes the step of corrugating both the outer and inner surfaces of the deflection section. In some embodiments, the method further includes reinforcing the deflection section with a wire coil. In some embodiments, the method further includes the steps of covering the wire coil to form a deflection section with an outer tubular core layer and forming an outer corrugated surface of the deflection section, and covering (over) the inner tubular core layer with the wire coil and forming an inner corrugated surface of the deflection section.

[0014] These and other features and advantages of this disclosure will be readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the attached claims. The following disclosure is presented with respect to aspects or embodiments, but it should be understood that each aspect may be claimed separately or in combination with the aspects and features of that embodiment or any other embodiment. [Brief explanation of the drawing]

[0015] [Figure 1] This is an elevation view of an example of an embodiment of an inversion device and system in which an auxiliary flexible tubular elongated member formed according to various principles of the present disclosure may be used. [Figure 2] Figure 1 is a schematic diagram of an inversion device and system that undergo distal inversion applied by an inversion system. [Figure 2A] Figure 2 is a detailed view of the deflection section of a flexible tubular elongated member, as shown within the dashed line area. [Figure 3] This is an elevation view of a flexible tubular elongated member having kink-resistant and / or deformation-resistant sections formed according to various principles of the present disclosure. [Figure 3A] This is a detailed view along the cross-section of the flexible tubular elongated member shown within the dashed area of ​​Figure 3. [Figure 4] This is a cross-sectional view of an example of an embodiment of a flexible tubular elongated member formed according to various principles of the present disclosure. [Figure 5] Figure 4 is an exploded perspective view of a flexible tubular elongated member. [Figure 6] A perspective view of an endoscopic suturing system according to an embodiment of the present invention. [Figure 7] A proximal perspective view of the suturing device of the endoscopic suturing system of FIG. 6. [Figure 8] A side view of the suturing device of indeterminate length of the endoscopic suturing system of FIG. 6. [Figure 9] A distal perspective view of a cap assembly attached to the distal end of an endoscope of an endoscopic suturing system. [Figure 10] A distal perspective view of a cap assembly of a suturing device with respect to an endoscope for an endoscopic suturing system. [Figure 11] A cross-sectional view taken along line XI-XI of FIG. 6. [Figure 12] A schematic distal view of a cap assembly of a suturing device with respect to an endoscope for an endoscopic suturing system. [Figure 13] A view similar to FIG. 12, showing the endoscope rotated and aligned. [Figure 14] A view similar to FIG. 10, with an endoscope shown being properly oriented and advanced at the distal end of the cap assembly. [Figure 15] A schematic view of a tape applicator. [Figure 16] A schematic view of a taping system for fixing a sheath of a suturing device to an endoscope. [Figure 17] A view showing the characteristics of the tape of the tape system. [Figure 18] A view showing the characteristics of the tape of the tape system. [Figure 19] A schematic view of an inversion system for an endoscopic system as applied to the proximal handle of the system. [Figure 20] A schematic view of an inversion system for an endoscopic system as applied to the proximal handle of the system. [Figure 21] A schematic view of the details of one embodiment of a lock for an inversion system. [Figure 22] This is a schematic diagram of an endoscopic system undergoing distal inversion, which is applied by an inversion system. [Figure 23] Figure 21 is a schematic diagram showing the details of the lock's operation. [Figure 24] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 25] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 26] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 27] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 28] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 29] This demonstrates the use of tape along the sheath to secure it to the endoscope. [Figure 30] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 31] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 32] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 33] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 34] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 35] This shows the tape separating from the cap assembly. [Figure 36] This shows the tape separating from the cap assembly. [Figure 37] This shows the disintegration of the sheath from the endoscope. [Figure 38] Figures 12 and 13 show examples of alignment of the cap assembly. [Figure 39] Figures 12 and 13 show examples of alignment of the cap assembly. [Modes for carrying out the invention]

[0016] Non-limiting embodiments of this disclosure are described by reference to the accompanying drawings, which are schematic and not intended to be drawn to any particular scale. The accompanying drawings are provided for illustrative purposes only, and dimensions, positions, order, and relative sizes reflected in the drawings may be modified. For example, a device may be enlarged so that details are identifiable, but is intended to be reduced in relation to mating into a working channel of a delivery catheter or endoscope, for example. For the purposes of clarity and brevity, not all elements are referenced in all drawings, nor are all elements of each embodiment shown where not an example is necessary to enable a person skilled in the art to understand this disclosure.

[0017] A more detailed explanation will be better understood in conjunction with the attached diagrams, where similar reference letters represent similar elements, as shown below. The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that this disclosure is not limited to the specific embodiments described and is therefore modifiable. All devices, systems, and methods discussed herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of this disclosure. Each example of an embodiment is provided for illustrative purposes and is merely an example, not the only way to implement these principles. Accordingly, references to elements, structures, or features in the drawings should be recognized as references to examples of embodiments of this disclosure, and this disclosure should not be understood as limiting to the specific elements, structures, or features illustrated. Other examples of ways to implement the disclosed principles will be apparent to those skilled in the art upon reading this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in this disclosure without departing from the scope or spirit of the subject matter of the invention. For example, a feature illustrated or described as part of one embodiment can be used in conjunction with another embodiment to result in further embodiments. Therefore, the subject matter of the invention is intended to encompass modifications and variations that fall within the scope of the appended claims and their equivalents.

[0018] This disclosure will be understood to be described in various levels of detail in this application. In some cases, details that are not necessary for a person skilled in the art to understand this disclosure, or details that would make it difficult to recognize other details, may be omitted. The terms used herein are for the sole purpose of describing specific embodiments and are not intended to limit them beyond the scope of the appended claims. Unless otherwise defined, the technical terms used herein should be understood as commonly understood by a person skilled in the art to which this disclosure belongs. All devices and / or methods disclosed and claimed herein can be fabricated and performed without undue experimentation in light of this disclosure.

[0019] As used herein, “proximal” means the direction or location closest to the user (such as a healthcare professional or clinician or technician or operator or physician, such terms are used interchangeably herein and are not intended to be limiting, and include automated control systems, etc.) when the device is in use (e.g., when the device is introduced, implanted, positioned, or delivered to a patient) and / or closest to the delivery device; “distal” means the direction or location furthest from the user when the device is in use (e.g., when the device is introduced, implanted, positioned, or delivered to a patient) and / or closest to the delivery device; “longitudinal” means extending along the longer or larger dimension of an element; “longitudinal axis” means extending along the longitudinal range of an element, but not necessarily in a straight line, and not necessarily maintaining a fixed configuration when the element bends or curves; “axial” generally means being along the longitudinal axis. However, it will be understood that references to axial or longitudinal movement relating to the system or its elements described herein do not need to be strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the element referred to. "Central" means at least approximately bisecting the center point and / or being approximately equidistant from the outer periphery or boundary, and "central axis" means, with respect to an opening, a line that at least approximately bisects the center point of the opening and extends longitudinally along the length of the opening if the opening includes, for example, a tubular element, channel, cavity, or bore. As used herein, "lumen," "channel," "bore," or "passage" are not limited to a circular cross-section. As used herein, the "free end" of an element is the end beyond which such an element does not extend. The terms "at the end," "on the end," "adjacent to the end," or "along the end" may be used interchangeably in this specification without limitation unless otherwise specified, and should be understood as being intended to indicate a general relative spatial relationship rather than a precisely defined location.As understood herein, “corresponding” is intended to convey relationships between components, parts, elements, etc., that are configured to interact with one another or to have different intended relationships with one another. Finally, references to “at” a place or part are intended to include in and / or around such a place or part (e.g., along it, adjacent to it, nearby, etc.).

[0020] According to various principles of this disclosure, inversion devices and systems are configured to be attached to a flexible elongated member. At least one flexible tubular elongated member may extend along or parallel to the flexible elongated member. This disclosure provides various improvements to articular movement devices and systems that can enable a desired deflection of the flexible elongated member to which the device and system is operatively associated, even to a point of inversion (bending backwards).

[0021] It is understood that as a portion of a flexible tubular elongated member flexes, the lumen within it also flexes. As the amount of flexing increases, the nearly circular cross-section of the lumen of the flexible tubular elongated member (e.g., an open accessory channel) can be stretched / ovalized, changing from a nearly circular to a nearly elliptical cross-section. In some examples, as the degree of flexing of a currently commercially available flexible tubular elongated member increases, for example to a point of inversion (e.g., beyond 90° from its initial position), the cross-section of the lumen within it continues to stretch until the flexible tubular elongated member folds and forms a kink. The cross-section of the lumen passing through the flexible tubular elongated member is distorted while stretching or kinking. In some cases, distortion narrows the lumen, reducing the flow capacity through the lumen (e.g., for irrigation, suction, and / or blowing) and / or increasing the amount of friction imposed on any instrument extending through it. In some cases, the lumen may narrow to the point of completely preventing the passage of an instrument or fluid through it. Furthermore, when the lumen of a flexible tubular elongated member forms a kink, even when the flexible tubular elongated member returns to its straight or unbent position, the original cross-sectional shape of the lumen within it may not be fully restored (for example, the lumen may become permanently distorted), and in many cases the “kinked” shape may persist, making further use of the lumen difficult. It should be understood that the herein reference to resistance to kinking and / or distortion is not necessarily limited specifically to kinking and / or distortion, but should be understood to include other generally undesirable effects of bending of a flexible tubular elongated member on the shape and / or effectiveness of the lumen through the flexible tubular elongated member.

[0022] In accordance with various principles of this disclosure, reversing devices and systems are operatively associated with a flexible elongated member to articulate and reverse the flexible elongated member. In some embodiments, the flexible elongated member already includes a reversing device and / or system (e.g., a steering system for a flexible elongated member in the form of a medical scope), and the reversing devices and / or systems of this disclosure may be used to complement and / or increase the maximum flexing capacity of the flexible elongated member. One or more flexible tubular elongated members may extend along the flexible elongated member and the reversing device. In accordance with various principles of this disclosure, at least the distal portion of the flexible tubular elongated member that can articulate and reverse together with the flexible elongated member is reinforced to prevent deformation, kinking, flattening, etc. of the flexible tubular elongated member, as well as deformation of the lumen therein.

[0023] In some embodiments, a flexible elongated member is a medical scope having one or more working channels extending longitudinally through it, and a flexible tubular elongated member provides one or more auxiliary working channels alongside the one or more working channels of the medical scope. However, the principles of the present disclosure are applicable to flexible tubular elongated members associated with reversal devices and / or systems, regardless of the form or features of the flexible elongated member to which the reversal device and / or system is operatively associated for articulation and / or reversal. Accordingly, it will be understood that references to medical scopes in this specification are for convenience only, and the present disclosure is not limited by the type of associated device to which a flexible tubular elongated member formed according to the principles of the present disclosure is operatively associated.

[0024] Various embodiments of devices and / or systems for inverting medical devices, as well as related methods, and various embodiments of flexible tubular elongated members that can be used with them and resist deformation of the lumen therein, as well as various methods associated therewith, will be described here with reference to the embodiments shown in the accompanying drawings. References in this specification to “one embodiment,” “embodiment,” “several embodiments,” “other embodiments,” etc., indicate that one or more specific features, structures, concepts, and / or properties in accordance with the principles of this disclosure may be included in relation to an embodiment. However, such references do not necessarily mean that all embodiments include a particular feature, structure, concept, and / or property, or that an embodiment includes all features, structures, concepts, and / or properties. Some embodiments may include one or more such features, structures, concepts, and / or properties in various combinations thereof. It should be understood that one or more of the features, structures, concepts, and / or properties described with reference to one embodiment may be combined with one or more of the features, structures, concepts, and / or properties of any of the other embodiments provided herein. In other words, any of the features, structures, concepts, and / or characteristics described herein can be mixed and adapted to create hybrid embodiments, and such hybrid embodiments are within the scope of this disclosure. Furthermore, references to “one embodiment,” “embodiment,” “several embodiments,” and “other embodiments” in various parts of this specification do not necessarily all refer to the same embodiment, and separate or alternative embodiments do not necessarily exclude other embodiments from each other. Moreover, it should be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and distinct from one another and may be used or exist individually or in various combinations with each other to create alternative embodiments that are considered part of this disclosure.Therefore, this disclosure is not limited to the embodiments specifically described herein, and it would be extremely cumbersome to describe all of the numerous possible combinations and partial combinations of features, structures, concepts, and / or properties, and the examples of embodiments disclosed herein are not intended to limit broader aspects of this disclosure. The various dimensions provided herein are examples, and it should be understood that those skilled in the art can easily determine an appropriate range of standard deviation and acceptable variation therefrom, which are covered by this disclosure and any claims associated therewith. The following description is merely an illustrative example of embodiments and is not intended to limit broader aspects of this disclosure.

[0025] Referring here to the drawings, Figure 1 shows an example of an embodiment of the inversion system 1000 formed according to various principles of the present disclosure. The illustrated example of an embodiment of the inversion system 1000 includes an inversion device 1010 operatively associated with a flexible elongated member 1100. The present disclosure is not limited to any particular flexible elongated member or medical device that is articulated and / or inverted by an inversion device 1010 or inversion system 1000 formed according to various principles of the present disclosure. Therefore, the flexible elongated member 1100 may be a component of a medical device, or it may refer to medical devices in general, such as a medical scope, and is not limited to simply referring to a flexible elongated member.

[0026] The inversion device 1010 includes an actuation component 1012, which may be referred to as a pull string 1012, for convenience purposes only. The pull string 1012 is an elongated element that acts from its proximal end 1012p and has sufficient strength to actuate the flexible elongated member 1100, to which the inversion device 1010 is actuated, at its distal end 1012d. The pull string 1012 may be formed from a woven fabric, polymer, or metal monofilament, multifilament, cable twisted element, etc., having appropriate strength, selected with reference to its longitudinal range, the flexibility of the flexible elongated member 1100, etc. The articulation and / or inversion of the flexible elongated member 1100 by the inversion system 1000 of this disclosure can advantageously direct the distal working end of the flexible elongated member 1100, or the opening of the working channel (of a medical scope), to a target site in the patient's body. The working end of the medical device (either a flexible elongated member 1100 in the form of a medical device, or a medical device extending through the working channel of the flexible elongated member in the form of a medical scope) can thereby be directed more precisely to the target site than has been possible with conventional systems and devices.

[0027] According to various principles of the present invention, the distal end 1012d of the pull string 1012 is operatively connected to the flexible elongated member 1100 adjacent to the section of the flexible elongated member 1100 that is articulated by the reversal system 1000. For maximum effect, the distal end 1012d of the pull string 1012 may be positioned at the most distal end of the flexible elongated member 1100 and / or operatively connected to it. However, it is understood that the distal end 1012d of the pull string 1012 does not need to be precisely positioned at the most distal end 1100d of the flexible elongated member 1100, but instead may be adjacent to the most distal end of the device to be articulated, and may be located somewhat proximal. The precise position may be determined by those skilled in the art, taking into account factors such as the flexibility of the device to be articulated and the anchored region of the pull string that allows for bending. The pull string 1012 may be operatively associated with the flexible elongated member 1100 in any of the following ways, and the disclosure is not limited thereto. For example, the inversion system 1000 may include one or more mounts configured to operatively associate the inversion device 1010 with the flexible elongated member 1100. In an example of the embodiment shown in Figure 1, the inversion system 1000 includes a distal mount 1020 having a section configured to engage with the flexible elongated member 1100. For example, the distal mount 1020 may include a concave section sized, molded, constructed, and / or dimensioned to receive a section of the flexible elongated member 1100. The distal mount 1020 may extend at least 180°, and in some embodiments beyond 180°, around the circumference of the flexible elongated member 1100 to maintain engagement with the flexible elongated member 1100, mounting thereon (e.g., by friction fit or interlock fit), etc. Alternatively, the distal mount 1020 may be a collar that surrounds the flexible elongated member 1100 and can be attached to it (by being fastened, bonded, clamped, etc.). Other configurations or forms of the mount are within the scope and spirit of the disclosure, and the disclosure is not limited in this respect.The distal end 1012d of the pull string 1012 is operationally associated with the distal mount 1020, for example, by being coupled (e.g., fixedly coupled), so that when the pull string 1012 is pulled proximal (for example, by pulling its proximal end 1012p), the distal end 1012d of the pull string 1012 pulls the distal mount 1020, causing the flexible elongated member 1100 to bend proximal (for example, in the direction of the bending arrow F), as shown in Figure 2.

[0028] To flex the flexible elongated member 1100, the working region 1012a of the pull string 1012, located proximal to the distal end 1012d of the pull string 1012, is held (e.g., fixed) against movement relative to the flexible elongated member 1100. (Meanwhile, it remains movable longitudinally along the flexible elongated member 1100). The working region 1012a can provide a pivot point for the pull string 1012 to flex the flexible elongated member 1100. The distance between the working region 1012a and the distal end 1012d of the pull string 1012 can be selected to achieve a desired bending radius. As can be understood by those skilled in the art, the material of the pull string 1012 and / or the flexible elongated member 1100 may influence the selection of such distance to achieve a desired articular movement of the flexible elongated member 1100. It will be further understood that the working region 1012a may be located independently of either the lumen / working channel through the system 1000.

[0029] In some embodiments, the working region 1012a of the pull string 1012 is held against lateral movement relative to the flexible elongated member 1100 and the distal mount 1020 using a pivot mount for the working region 1012a. Such a pivot mount may be similar to the distal mount 1020 described above, and therefore, for the sake of brevity, the above description is used by reference without intent to limit. In some embodiments, the pivot mount that holds the working region 1012a of the pull string 1012 laterally relative to the flexible elongated member 1100 may be the distal end 1030d of a flexible tubular elongated member 1030 (e.g., a sheath) that extends along the flexible elongated member 1100 and defines a lumen into which the pull string 1012 extends in a translational / movable manner. The flexible tubular elongated member 1030 generally extends from the proximal end 1100p of the flexible elongated member 1100 toward the distal end 1100d of the flexible elongated member 1100.

[0030] To enable the operation of the pull string 1012 and to provide the extent to which the pull of the pull string 1012 along it to the flexible elongated member 1100 causes deflection of the distal deflection section of the flexible elongated member 1100, the operating region 1012a of the pull string 1012 is located proximal to the distal end 1012d of the pull string 1012. In some embodiments, the operating region 1012a may be considered to be determined by the position of the pivot mount for the operating region 1012a. For example, a pivot mount configured similarly to the distal mount 1020 has the distal end 1012d of the pull string 1012 moved proximal to the position where it is operationally associated with the flexible elongated member 1100 (for example, moved proximal to the distal mount 1020 to which the pull string 1012 is operationally associated), thereby moving the working area 1012a of the pull string 1012 proximal to the distal end 1012d of the pull string 1012 to achieve the desired deflection of the pull string 1012. In an embodiment in which the pivot mount holding the working area 1012a of the pull string 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 entire length of the flexible elongated member 1100. As shown in Figures 1 and 2, the distal end 1030dm of the example embodiment of the flexible tubular elongated member 1030 is positioned proximal to the distal end 1100d of the flexible elongated member 1100. The pull string 1012 extends distally from the flexible tubular elongated member 1030 and distal to the distal end 1030dm of the flexible tubular elongated member 1030, and is operationally associated with the distal end 1100d of the flexible elongated member 1100. Thus, in some embodiments, the distal end 1030dm of the flexible tubular elongated member 1030 may provide an anchor or pivot mount / pivot point for the operating region 1012a of the pull string 1012, for example, by acting as a pivot mount. It will be understood that the distance between the distal end 1012d of the pull string 1012 and the working region 1012a may affect the bending radius of the flexed region of the flexible elongated member 1100.In some embodiments, as shown in Figures 1 and 2, the pull string 1012 is operatively associated with an adapter / proximal mount 1040 provided along the proximal end 1000p of the inversion system 1000, for example, along the proximal end 1030p of a flexible tubular elongated member 1030, along which the pull string 1012 of the inversion device 1010 extends.

[0031] As can be understood, the inversion device and / or system of the present disclosure may optionally be operationally associated with one or more devices, such as devices used in conjunction with and / or independently of the flexible elongated member 1100, to achieve further articulation, further flexibility, and / or reach, etc., independently of other devices in the system. In some embodiments, one or more auxiliary flexible tubular elongated members 1200 may extend substantially longitudinally along / parallel to the flexible elongated member 1100 (for example, along / parallel to the outside or outer surface of the flexible elongated member 1100) to provide one or more auxiliary working channels throughout the system, etc. In some embodiments, the distal end 1200d of the auxiliary flexible tubular elongated member 1200 is operationally associated with (e.g., coupled to) the distal mount 1020 of the inversion system 1000 so that the auxiliary flexible tubular elongated member 1200 is inverted in a manner similar to the inversion of the flexible elongated member 1100 described above. In some embodiments, the proximal mount 1040 is configured to facilitate the advance of a device through a lumen defined within the flexible tubular elongated member 1030, for example, by providing ports 1041, 1043 that facilitate access to the lumen within the flexible tubular elongated member 1030. In some embodiments, the inversion system 1000 formed according to various principles of the present disclosure may be operationally associated with a flexible elongated member 1100 having one or more working channels defined / extending through it. In some embodiments, each of the one or more auxiliary flexible tubular elongated members 1200 has at least one auxiliary working channel defined through it. The auxiliary work channels of the auxiliary flexible tubular elongated member 1200 enhance the work channels of the entire system (for example, providing work channels in addition to those provided by the flexible elongated member 1100). Additional devices may extend through the auxiliary work channels defined through the auxiliary flexible tubular elongated member 1200.

[0032] In accordance with various principles of this disclosure, an inversion system 1000 formed in accordance with various principles of this disclosure can articulate, flex, and / or invert a flexible tubular elongated member operatively associated with it to such an extent that its lumen can elongate or ovalize the flexible tubular elongated member (for example, if the flexible tubular elongated member is circular in its neutral elongated shape) or even deform it. If the lumen is deformed, it may not function properly as a working channel, such as being able to effectively deliver or retract further instruments or materials through the lumen. In a worse scenario, the flexing or inversion of the flexible tubular elongated member may cause permanent deformation of the lumen. For example, if the flexible tubular elongated member flexes more than about 90°, for example more than about 145°, more than about 180°, and even more than about 210°, or beyond (including various increments in between, such as 1° increments), the lumen within it may become deformed. A similar problem applies to the lumen of the auxiliary flexible tubular elongated member 1200 used with system 1000.

[0033] In accordance with various principles of this disclosure, flexible tubular elongated members, such as those disclosed herein, which are operationally associated with inversion systems and / or devices, are formed, configured, and / or dimensional to resist kinking and / or bending or flexing that could distort or otherwise affect the shape and / or functionality of their lumen. It will be understood that, for convenience and without intent to limit, "resistance to kinking and / or bending" is used herein. In some embodiments, at least a certain section of a flexible tubular elongated member (e.g., a feature portion of the wall of the flexible tubular elongated member) is formed, configured, and / or dimensional to facilitate increasing bending without causing kinking and distortion of the lumen defined therein. In some embodiments, the material of the flexible tubular elongated member is reinforced. In some embodiments, the shape, configuration, dimensions, etc., of the flexible tubular elongated member are modified by adding reinforcing material and / or structure to the wall of the flexible tubular elongated member. References to improvements to flexible tubular elongated members are intended to include auxiliary flexible tubular elongated members as described herein, and references to “auxiliary” flexible tubular elongated members will be understood to be applicable to flexible tubular elongated members in general unless otherwise stated. In some embodiments of flexible tubular elongated members formed according to various principles of this disclosure to resist deformation / kinking, a section of the flexible tubular elongated member is configured to facilitate the bending of that section of the flexible tubular elongated member without kinking and / or deformation. In an example of an embodiment of the auxiliary flexible tubular elongated member 1200 shown in Figure 2 and Figure 3 itself, only the bending section 1200f of the auxiliary flexible tubular elongated member 1200 (i.e., not the entire longitudinal range / length) is kink-resistant and / or deformation-resistant. In the illustrated example of the embodiment, the flexure section 1200f is along the distal end 1200d of the auxiliary flexible tubular elongated member 1200. However, the disclosure is not limited to this respect.

[0034] The flex section, which is the kink resistance and / or strain resistance of a flexible tubular elongated member formed according to various principles of this disclosure, can be formed in various ways to provide desired resistance to kinking and / or strain. In some embodiments, at least one section of the flexible tubular elongated member may be configured to be articulated to facilitate its flexing. In some embodiments, one or both of the surfaces of at least one section of the flexible tubular elongated member (e.g., the outer surface, or the 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, are shaped, configured, and / or dimensional to facilitate the flexing of the section without kinking and / or deformation. In some embodiments, a section of a flexible tubular elongated member formed according to various principles of this disclosure is wavy or otherwise not straight or flat to facilitate its flexing. The configuration of sections of a flexible tubular elongated member that facilitates bending without kinking may be described as corrugated, bellows-like, grooved, or otherwise not straight / flat, and those skilled in the art will understand that the properties of such sections can be understood by considering the following description. In some embodiments, a series of ridges may be formed on the surface (external and / or internal) of a portion of the flexible tubular elongated member when viewed from the side and / or in cross-section. In some embodiments, the walls of a kink-resistant and / or deformation-resistant flexible tubular elongated member formed according to various principles of this disclosure may have alternating sections of thin and thick wall thicknesses, such as regions or sections extending circumferentially along the longitudinal axis of the flexible tubular elongated member 1200 with alternating thicknesses. In other words, the walls of a kink-resistant and / or deformation-resistant flexible tubular elongated member may include one or more wall regions that are thinner than the immediately proximal and immediately distal wall regions.Walls having ridges or corrugations, etc., of a flexible tubular elongated member formed according to various principles of this disclosure can be made more flexible, for example, by making the wall more elastic, and / or by reducing the stress on the wall in thinner regions of the wall (which flex more easily than thicker regions), and / or by increasing or otherwise adjusting the difference between the inner and outer curvature of the bent portion of the flexible tubular elongated member.

[0035] An example of an embodiment of a kink-resistant and / or deformation-resistant flexible tubular elongated member is shown in Figure 2A, a detail view showing the distal portion 1200d of the auxiliary flexible tubular elongated member 1200 in Figure 2. As can be understood by referring to Figure 2A, at least the outer surface (visible illustrated outer surface) of the illustrated section is formed in a corrugated shape. As the flexible tubular elongated member 1200 is bent, the geometry of the ridges (or other corrugated shapes) allows for a greater degree of bending while maintaining the cross-sectional shape of the flexible tubular elongated member 1200, typically a circular geometry. In some embodiments, the shape / configuration of at least the outer surface of the section of the flexible tubular elongated member 1200 shown in Figure 2A is analogous to a bellows or accordion, allowing the internal radius of the bent flexible tubular elongated member 1200 to collapse and the external radius of the bent flexible tubular elongated member 1200 to expand. An example of such an embodiment of the configuration of at least the outer surface of the deflection section 1200f of an example of an auxiliary flexible tubular elongated member 1200 shown in Figure 3 is shown in detail in Figure 3A. As can be understood, a flexible tubular elongated member having a corrugated or the like allows for greater flexibility without kinking and distortion of its lumen than can be achieved by a prior art flexible tubular elongated member.

[0036] As shown in Figures 1 and 2, an auxiliary flexible tubular elongated member 1200, formed according to various principles of this disclosure, to be used in conjunction with an inversion system 1000 and / or device 1010 as described herein, allows the delivery of a device or material through its lumen to extend not only linearly from the auxiliary flexible tubular elongated member 1200, 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 flexed section of the auxiliary flexible tubular elongated member 1200). More specifically, a device or material delivered through a kink-resistant and / or deformation-resistant auxiliary flexible tubular elongated member 1200, formed according to various principles of this disclosure, can extend toward the proximal end of the auxiliary flexible tubular elongated member 1200, beyond approximately 90° from the initial distally extending direction of the auxiliary flexible tubular elongated member 1200, as shown in Figure 2. As can be understood, the kink resistance and / or deformation resistance of the flex section 1200f of the auxiliary flexible tubular elongated member 1200 in the direction from the initial distal direction (generally aligned with the more proximal section) toward the proximal end 1200p of the auxiliary flexible tubular elongated member 1200 does not distort or otherwise obstruct the delivery of devices and / or materials through the distal flex section 1200f, as can be understood with reference to Figure 2A. Taking the above into consideration, the inversion system 1000 and / or device 1010 formed according to the various principles of this disclosure can cause the distal deflection section 1200f of the kink-resistant and / or deformation-resistant auxiliary flexible tubular elongated member 1200 to bend more than about 90°, for example more than about 145°, for example more than about 180°, up to about 210°, or even more, from an initial position extending distally to the system 1000 / device 1010 (and generally from an initial position axially aligned with the proximal portion of the auxiliary flexible tubular elongated member 1200), for example more than about 145°, for example more than about 180°, up to about 210°, or even more (including various increments in between, such as 1° increments). Furthermore, taking the above into consideration, the kink-resistant and / or deformation-resistant walls of the auxiliary flexible tubular elongated member 1200 allow the passage of a device or material through its lumen without the deflection of the auxiliary flexible tubular elongated member 1200 affecting the delivery and / or movement of the device or material.

[0037] It is understood that the formation of corrugations along a flexible tubular elongated member (e.g., by providing wall sections thinner than directly adjacent proximal and distal sections) can result in a loss of column strength and / or other weakening of the flexible tubular elongated member. In some embodiments, the walls of a kink-resistant and / or deformation-resistant flexible tubular elongated member formed according to various principles of this disclosure are reinforced. In some embodiments, a kink-resistant and / or deformation-resistant flexible tubular elongated member is reinforced with filaments, wires, braids, meshes, etc., which are more rigid than the material from which the tubular elongated member is formed. For example, a kink-resistant and / or deformation-resistant flexible tubular elongated member may have a tubular wall formed of a flexible, elastic, biocompatible material (e.g., polymers such as thermoplastic elastomers, or PEBAX® block copolymers composed of rigid polyamide and soft polyether blocks), and the filaments may be formed of a harder material such as metal. In some embodiments, the filament is a coiled metal wire extending through the wall of a kink-resistant and / or deformation-resistant flexible tubular elongated member formed according to various principles of the present disclosure. In some embodiments, the filament extends through thicker portions of the corrugated wall. In some embodiments, the filament contributes to the increase in wall thickness. In some embodiments, the filament is a round wire or a flat wire. If the filament is a braided or mesh configuration, the braid pattern may have a wire pitch of 1:1, 1:2, 2:2, etc., which may be selected and / or controlled to impart various levels of reinforcement.

[0038] In some embodiments, a polymer tubular wall is formed covering a coiled wire, and a helical groove is formed in the resulting flexible tubular elongated member along the outer shape of the coiled wire, thereby forming a kink-resistant and / or deformation-resistant flexible tubular elongated member according to various principles of the Disclosure. In some embodiments, the kink-resistant and / or deformation-resistant flexible tubular elongated member 1200 of the Disclosure comprises an inner tubular core layer, a coiled wire disposed on the inner tubular core layer, and an outer tubular core layer disposed on the coiled wire, as shown in Figure 4 (showing a cross-sectional view of an example of a multilayer wall embodiment of a kink-resistant and / or deformation-resistant flexible tubular elongated member formed according to various principles of the Disclosure). Figure 5 shows an exploded view of an example embodiment of a multilayer kink-resistant and / or deformation-resistant flexible tubular elongated member 1200 formed according to various principles of the Disclosure. The inner layer (also referred to as the inner core), the coiled wire, and the outer layer (also referred to as the outer core) may be joined together in any of a variety of ways to achieve a strong bond between them. For example, the materials of at least the inner and outer layers may be fused together (e.g., through the spacing between the coils of wire positioned between them). In some embodiments, various parameters of the reinforcing coils (e.g., the spacing / pitch between coils, the wire diameter, the wire shape (circular vs. flat vs. square)) may be adjusted to the specific needs of the system in which kink-resistant and / or deformation-resistant flexible tubular elongated members are to be used. Incidentally or alternatively, the filling of the inner layer and / or the outer layer between the coil spacings may be adjusted to achieve a desired corrugation effect on the outer and / or inner diameters of the kink-resistant and / or deformation-resistant flexible tubular elongated members. Following the fusion of the inner core, coiled wire, and outer core, the outer surface of the reinforced catheter has a helical groove that follows the outer geometry of the coiled wire, as shown in Figure 3A. It should be understood that the configuration shown in Figure 3A is not limited to the fact that kink-resistant and / or deformation-resistant flexible tubular elongated members result from such formations.

[0039] As described above with reference to an example of an embodiment of the inversion system 1000 and inversion device 1010 shown in Figure 2, the distal end 1030dm of the flexible tubular elongated member 1030 of the illustrated inversion system 1000 is located proximal to the distal mount 1020 through which the distal end 1012d of the pull string 1012 is operationally associated. In some embodiments, the flexible tubular elongated member 1030 includes one or more lumens through which an auxiliary flexible tubular elongated member 1200 can extend. It may be desirable to extend the distal end 1200d of the auxiliary flexible tubular elongated member 1200 to substantially the same position as the distal end 1100d of the flexible elongated member 1100 (for example, to extend the instrument to a target site where the flexible elongated member 1100 is positioned). Since the flexible tubular elongated member 1030 is shorter than the flexible elongated member 1100 along which it extends, the auxiliary flexible tubular elongated member 1200 must extend beyond the most distal end 1030dm of the flexible tubular elongated member 1030 in order to reach the distal end 1100d of the system 1000. Although the auxiliary flexible tubular elongated member 1200 is shown to exit the flexible tubular elongated member 1030 at substantially the same axial position as where the pull string 1012 exits and / or substantially the same position as the pivot mount for the working region 1012a of the pull string 1012, it should be noted that the axial position where the auxiliary flexible tubular elongated member 1200 exits the flexible tubular elongated member 1030 may be proximal or distal to the pivot mount for the working region 1012a of the pull string 1012, and the 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 need to have additional reinforcement such as that which may be provided to portions extending outside and / or distally beyond the flexible tubular elongated member 1030. In some embodiments, the portion of the auxiliary flexible tubular elongated member 1200 extending within the flexible tubular elongated member 1030 is constructed using a standard material such as a thermoplastic elastomer extruded to form a desired geometric shape, including the formation of one or more open lumens.One or more lumens may have a substantially circular cross-section. In some embodiments, each lumen of the flexible tubular elongated member 1030 may be individually reinforced instead of, or in addition to, the flexible tubular elongated member 1030 or the auxiliary flexible tubular elongated member 1200.

[0040] The distal portion 1200d of the auxiliary flexible tubular member 1200, which extends beyond the most distal end 1030dm of the flexible tubular member 1200, is the portion that is inverted by the inversion system 1000 and device 1010. Thus, in some embodiments, only the distal portion 1200d of the auxiliary flexible tubular member 1200, which extends beyond the most distal end 1030dm of the flexible tubular member 1030, is reinforced or otherwise formed to resist kinking and / or deformation according to various principles of this disclosure. In other words, the flex section 1200f of the auxiliary flexible tubular member 1200 may be provided at least (in some embodiments, only) along the section of the auxiliary flexible tubular member 1200 that extends distal to the most distal end 1030dm of the flexible tubular member 1030.

[0041] The kink-resistant and / or deformation-resistant distal flexure section 1200f may be bonded, fused, or otherwise joined (preferably to a fixed connection) 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 joined to each other in any way known to those skilled in the art to achieve a desired connection so that the connection remains bonded during normal use of the kink-resistant and / or deformation-resistant flexible tubular elongated member.

[0042] The length of the distal bending section 1200f can be selected based on the distance between the most distal end 1030dm of the flexible tubular elongated member 1030 and the distal end 1000d of the system 1000 (for example, the position 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 scope, the length of the distal bending section 1200f may correspond to the length of the distal "bending section" of a standard medical scope. Since the length of a kink-resistant and / or deformation-resistant flexible tubular elongated member may be more expensive to manufacture than the more typical proximal section of a kink-resistant and / or deformation-resistant flexible tubular elongated member, the overall cost of a kink-resistant and / or deformation-resistant flexible tubular elongated member can be reduced by forming only the most bent / serpentine portion to be kink-resistant and / or deformation-resistant.

[0043] As can be understood, kink-resistant and / or deformation-resistant flexible tubular elongated members formed according to the various principles of this disclosure are configured to allow the movement of devices or materials through their lumen to be unimpeded, even in extreme degrees of deflection. To further improve the ease of movement of devices or materials through the lumen of kink-resistant and / or deformation-resistant flexible tubular elongated members according to the various principles of this disclosure, the lumen may be coated and / or injected and / or formed with a low-friction and / or lubricating material. In some embodiments, such material is limited to the distal deflection section of the kink-resistant and / or deformation-resistant flexible tubular elongated member. However, it will be understood that such material may, if desired, be provided along the entire length of the kink-resistant and / or deformation-resistant flexible tubular elongated member. In some embodiments, additives may be included in the material of the auxiliary flexible tubular elongated member 1200 for one or more purposes (e.g., reducing friction between the lumen within the auxiliary flexible tubular elongated member 1200 and another element extending through it). For example, one or more additives may be compounded / mixed with various elastomers (e.g., block copolymers such as those composed of rigid polyamide blocks and soft polyether blocks, such as raw material PEBAX®) to achieve desired properties that can improve the functionality of the auxiliary flexible tubular elongated member, the kink-resistant and / or deformation-resistant flexible tubular elongated member, and / or the system as a whole. In some embodiments, the material is polytetrafluoroethylene (PTFE) material as 2-micron (2 μm) fine particles dispersed in or coated on the material forming the tubular wall of the kink-resistant and / or deformation-resistant flexible tubular elongated member. In some examples, the material is flowed through the lumen of the kink-resistant and / or deformation-resistant flexible tubular elongated member. In some embodiments, the material flowing through the lumen contains a solvent, leaving behind a thin layer of friction-reducing and / or lubricating material such as PTFE.Incidentally or alternatively, a low-friction inner liner (e.g., formed from PTFE) may be added in the form of a flash (e.g., a PTFE flash, or another PTFE-like solvent-supported solution that can be flashed) and / or as a layer fused to the inner / internal surface of the lumen defined through the auxiliary flexible tubular elongated member 1200. In some embodiments, the lumen of the flexible tubular elongated member 1200 may be reinforced in other ways to allow for gradually increasing or maximum deflection without kinking. It will be understood that various other lumens of the system 1000 described herein may also benefit from such treatment.

[0044] It should be understood that the proximal section of a kink-resistant and / or deformation-resistant flexible tubular elongated member, which may not be as kink-resistant or deformation-resistant as the distal flex section, may have friction-reducing additives or coatings, or any other treatments as described with respect to the distal section of a kink-resistant and / or deformation-resistant flexible tubular elongated member, extending through the lumen therein. The friction-reducing and / or lubricating material in the lumen of the distal flex section may reduce friction or provide further lubrication, taking into account its extreme flexing and the resulting flexing of its lumen.

[0045] While the above disclosure refers to a flexible tubular elongated member used in conjunction with an inversion device and / or system, the principles of the present disclosure may be implemented or applied to any flexible tubular elongated member having a lumen or channel inside which it is subject to a degree of deflection up to and beyond 180 degrees of inversion.

[0046] In consideration of the foregoing, it can be understood that the inversion system 1000 formed according to the various principles of this disclosure may be used in conjunction with the articulation mechanism of a flexible elongated member 1100 on which the inversion system 1000 is operated. In this way, the inversion system 1000 acts as an aid to the existing system of the flexible elongated member 1100, such as normalizing the articulation function of the existing system of the flexible elongated member 1100. The inversion system 1000 of this disclosure ensures that a desired degree of inversion is achieved for procedures performed using the flexible elongated member 1100. In some embodiments, the inversion system 1000 formed according to the various principles of this disclosure, used in conjunction with and mounted on an existing device or system, facilitates articulation. For example, pulling an actuating device such as the pull string 1012 in the above example of an embodiment of the inversion system 1000 that extends along / beside the external / outside of the device or system being actuated applies a tangential force that can apply a greater force to the device or system than the force applied by an actuating element that extends through it (intowards the device / system rather than outside it). Furthermore, the inversion 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 inversion system 1000 as described herein enables inversion to a greater degree or range than previously achievable. Also, kink-resistant and / or deformation-resistant flexible tubular elongated members formed according to the various principles of this disclosure will not kink, deform, strain, or fail to function as intended and can be used with such an inversion system 1000.

[0047] The various principles of this disclosure described above can be implemented in various ways and / or applied to various medical devices, examples of which are described below. It will be understood that the various methods described with respect to the described examples of embodiments may be applied to other embodiments, such as those described more broadly / generally above.

[0048] Referring to Figures 6 to 9, the endoscopic treatment system 10 comprises an endoscope system 11 and an endoscopic suturing system 21. The endoscope system 11 comprises an endoscope 12, an image display unit 14, an image processing device 16, a light source 18, and a suction device 20. According to one embodiment, the endoscope 12 generally has a small external shape with a diameter of 5 to 10 mm. However, the size of the endoscope is not important, and the elements described herein can be adapted to endoscopes of other sizes. In the illustrated embodiment, the endoscope 12 has a single instrument channel 13 and an optical lens 15 (Figure 9). However, since the operation of the system does not necessarily require the use of an instrument channel through the endoscope, the endoscope 12 may have two or more instrument channels, or may not have any instrument channels at all. The endoscope 12 includes a distal end 44, a proximal end 45, and a longitudinal axis A extending between them.

[0049] The suturing system 21 includes a suturing device 22 (Figure 7), a needle assembly 70 (Figure 9) that can move through tissue by the suturing device 22, and first and second devices 38, 40 (Figure 9) used in conjunction with the suturing device 22.

[0050] Referring to Figures 6, 7, and 8, the suturing device 22 has a proximal operable handle 24 with a mounting bracket 26 and a collar 28, at which the handle is detachably coupled to the endoscope 12. The bracket 26 includes first and second instrument ports 30, 32, through which instruments can be received into first and second catheters 34, 36, respectively. First and second tubular connectors 33, 35 are aligned with the ports 30, 32 that connect to the first and second catheters 34, 36.

[0051] The transmission assembly 42 includes a transmission sheath 46 and a transmission cable 48 that is displaceable within the transmission sheath 46, both of which are connected to the handle 24. The transmission sheath 46 is connected to a first part of the handle (i.e., a stationary member), and the transmission cable 48 is connected to a second part of the handle (i.e., a movable lever), so that when the handle 24 is operated, the cable 48 is displaced within the transmission sheath 46.

[0052] The first and second catheters 34, 36 and the transmission assembly 42 extend from the proximal handle 24 along the outside of the endoscope 12 to the distal cap assembly 50. The distal cap assembly 50 is fitted to be mounted on the distal end 44 of the endoscope 12, and the handle 24 remotely operates the cap assembly 50 via the transmission assembly 42.

[0053] Referring to Figure 9, the cap assembly 50 includes a mount 52, a U-shaped support bracket 54 extending distally from the mount, and a needle arm 58 rotatably mounted on the bracket 54 using a first pin 60. A bell crank 64 is rotatably attached to the support bracket 54 at a second pin 66 and engages with the needle arm 58 in 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 by a clevis 68. When the transmission assembly 42 is operated by the handle 24, the bell crank 64 rotates, causing the needle arm 58 to rotate between an open position and a closed position.

[0054] The needle assembly 70 is coupled to the needle mount 83 at the end of the needle arm 58. The needle assembly 70 includes a tubular needle body 74, a needle tip 76, and a suture 78 coupled to the needle body. The needle body 74 includes a side opening 80 through which the suture 78 passes and extends, a first end 82 to which the needle assembly is coupled to the needle mount 83, and a second end 84 to which the tip 76 is coupled. The tip 76 defines a tissue puncture taper. The suture 78 may be formed from any material commonly available for surgical sutures, such as nylon, polyolefin, PLA, PGA, stainless steel, or nitinol. One preferred needle assembly is described in detail in U.S. Patent No. 9,198,562, which is incorporated herein by reference in whole for any purpose.

[0055] Referring to Figures 9 and 10, the mount 52 of the cap assembly 50 includes a side recess 85 that receives the transmission assembly 42, and a first through-bore 86 and a second through-bore 88. The first through-bore 86 is positioned to align with both the needle mount 83 and the needle assembly 70 of the needle arm 58 when the needle arm 58 is in the closed position. A tissue guide 87 extends distally over the mount 52 from above the first through-bore 86 and provides a surface for stabilizing the tissue when punctured by the needle assembly 70. The second through-bore 88 is positioned between the first through-bore 86 and the support bracket 54. More specifically, the axial center of the second through-bore 88 is positioned between the first through-bore 86 and the pin 60 (or axis) on which the end effector and / or assembly 58 rotates. The first through bore 86 and the second through bore 88 may be parallel to each other and along the longitudinal axis A of the endoscope, or the second through bore 88 may be angled obliquely with respect to the first through bore 86 to orient the second device 40 to the needle path in a particular orientation, as further described below. The mount 52 is constructed such that when the cap assembly 50 is connected to the endoscope 12, the first and second through bores 86, 88 are positioned radially outward of the outer shape of the endoscope 12, as described below.

[0056] Referring to Figures 8 and 11, the distal end of the first catheter 34 is fixed in a first through bore 86, and its proximal end is connected to a first connector 33 on the handle bracket 26. The distal end of the second catheter 36 is fixed in a second through bore 88, and its proximal end is connected to a second connector 35 on the handle bracket 26. The first and second catheters 34, 36 may be separate catheters or separate lumens of a common catheter. In a preferred embodiment, the catheters 34, 36 are separate catheters covered along substantially all of their total length (e.g., at least 80 percent, more preferably at least 90 percent) by a preferably crescent-shaped common sheath 89. Alternatively, the common sheath 89 may extend along the total length of the catheters 34, 36, along the length of a portion thereof, or may be provided in segments along selected portions of the catheters 34, 36. In a preferred embodiment, the common sheath 89 is flexible and defines a lumen 90 for the catheter 34, a lumen 92 for the catheter 36, and a lumen 94 for both the transmission assembly 42 and the inverting pull string 100, the functions of which are described below. If necessary, separate lumen may be provided for the transmission assembly 42 and the pull string 100. A recessed area 96 is provided along the length of the sheath 89, and it is preferable that the sheath be able to extend close to the outside of the endoscope 12 of appropriate dimensions. In one embodiment, the sheath 89 is adapted to accommodate the endoscope by extending more than 180° around the circumference of the endoscope 12, which is preferably of appropriate dimensions, thereby partially surrounding the outside.

[0057] Referring to Figures 8 and 9, the first catheter 34 is adapted to receive a first device 38 having a distal end effector capable of receiving and grasping the needle assembly 70. The second catheter 36 is adapted to receive a second device 40 having a distal end effector capable of engaging with tissue, and to pull the tissue back into the needle path so that the tissue can be punctured by the needle assembly 70 when the needle assembly 70 is moved from an open position to a closed position.

[0058] Referring to Figure 10, the cap assembly 50 is fixed to the distal end 44 of the endoscope 12 by a peripheral engagement structure adapted to be positioned about 180°, preferably slightly larger than 180°, around the circumference of the distal end of the endoscope 12. In one embodiment, the structure is an elastic clip 102 integrated into the proximal end of the mount 52. The clip 102 includes an opening 104 that allows the distal end 44 of the endoscope 12 to access it. The clip 102 may be formed from ABS plastic, other suitable plastics, elastic materials, and polymer-coated metals.

[0059] Referring to Figures 10, 12, 13, and 14, a stop 106 is formed at the distal end of the clip 102. The distal end 44 of the endoscope 12 is pushed into a recess 104 of the clip 102 and fitted to seat against the stop 106. The stop 106 is preferably formed around the stop 106 as a first recess 108 and includes a largest first clearance window that allows passage access to the instrument channel 13 on various endoscopes from multiple manufacturers when the endoscope is properly rotatably aligned within the clip 102, and smaller second and third clearance windows formed on either side of the first recess 108 at approximately 60°, which prevent interference with the optical lens 15 and other working features of various endoscopes. The first recess 108 is located radially inward of the instrument channel lumen 88. To align the endoscope feature with respect to the first, second, and third recesses 108, 110, and 111, the stopper 106 includes a guide 112 to which the instrument channel 13 or other designated feature of the endoscope is rotationally aligned. For example, if the endoscope does not include an instrument channel 13 (and is therefore not required in the system described herein), the optical lens may be designated to align with the guide 112. In a preferred embodiment, the guide 112 is a color contrasting with the color of most of the cap assembly provided around the first recess 108. By thus rotationally aligning the designated endoscope feature with respect to the guide 112 (in the direction of arrow 115), the optical lens 15 of the endoscope ensures an unobstructed field of view and proper orientation with respect to the suturing arm 58, instrument channel lumen 88, and needle exchange lumen 86 without the need to activate the endoscope, regardless of the type of endoscope from the primary manufacturer used with the system. In other words, the relative orientation, access, and field of view can be confirmed without the need to power on the endoscope and preview the field of view from the lens 13 on the display 14 prior to the procedure. This significantly reduces the preparation time before the procedure.The positions of the first and second recesses 108, 110 and the indicator section 112 relative to the suturing arm 58, the instrument channel lumen 88, and the needle exchange lumen 86, as well as the area covered by the distal end of the endoscope and obscured from the field of view, are based on the analysis of scans of multiple distal ends of the endoscope.

[0060] Referring to Figure 14, the elastic clip 102 further includes a plurality of longitudinally displaced (proximal and distal) integrated hooks 120, 122. In one embodiment, just two hooks are provided on the clip. The hooks are preferably identified by a color that is in contrast to the surrounding area of ​​the end cap and the majority of the cap assembly. The hooks 120, 122 may also be marked, for example, "1" and "2", according to the intended order of use, as further described below.

[0061] Referring to Figure 15, the 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. An illustrated embodiment of one embodiment of the handle 126 is preferably monolithic and includes a wider proximal end 126p for stable gripping in the user's hand and a narrower extension 130 for discreetly reaching around the distal end 44 of the endoscope 12 and the cap assembly 50 during tape application. The extension 130 includes a spool mount 132. In a preferred embodiment, the spool mount 132 is in the form of a male thread. The spool 128 is rotatably fixed to the spool mount 132 of the handle 126 during use. The spool 128 includes a female thread (not shown) that allows the spool to rotate on the spool mount 132 in a rotational direction opposite to the intended application of the tape, such that when tension is applied to the tape, the spool is pulled in a direction that rotatably secures the spool to the mount. Other fixing interfaces between the mount and the spool can be used. The tape has a non-adhesive free end 134, which is preferably provided with a reinforced and sized integrated loop 136 for attachment to one of the hooks 120, 122. The reinforced integrated loop 136 is preferably provided in a color to facilitate its placement in the operating room environment. For example, the loop 136 is preferably opaque, and the loop is preferably color-matched to the hook on the cap assembly. Both may be opaque white. In one embodiment, the loop 136 has a diameter of about 2.5 mm. The diameter of the spool 128 is preferably smaller than the diameter of the endoscope 12, providing a mechanical advantage when winding the tape 129 to secure the clip 102 and the endoscope 12 to each other. In one embodiment, the spool 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 consistent adhesion along its length and is adapted to adhere primarily to its own back surface under tension, as well as to both the endoscope 12 and the clip 102.Alternatively, the tape 129 may have a non-adhesive first portion for initially wrapping around the endoscope and a second adhesive portion for wrapping around and adhering to the back of the first portion and the back of the second portion.

[0062] Referring here to Figures 16, 17, and 18, a tape system for securing a portion of the sheath to the endoscope is also provided. The sheath 89 is provided with multiple strips of tape 140 pre-positioned along the length of the sheath 89. In a preferred embodiment, three tape strips are used, with a first strip 140a located at the distal end of the sheath, a second strip 140b positioned substantially centrally along the length of the sheath, and a third strip 140c located between the first strip 140a and the second strip 140b, preferably closer to the first strip 140a. This limited use of tape and specific spacing has been shown to provide good stabilization of the sheath to the endoscope during use. That is, additional strips of tape can be pre-positioned on the sheath and used in the manner described above. According to one embodiment of the system, the tape strip 140 has a first adhesive portion 141 that is pre-applied to the sheath 89, a second portion 142 that is non-adhesive to prevent adhesion to the endoscope when the tape is wrapped around the endoscope, and a third portion 144 that extends from the second portion 142 to the free end 146 of the tape strip, is adhesive, and is adapted to adhere to the back surface of the tape when the tape is wrapped around the endoscope 12 and the sheath 89. According to another embodiment, each tape strip 140 includes a pull-off protective strip 148 that covers the second portion 144. The pull-off protective strip 148 extends to cover the third portion 144 of the tape and is bent as an L-shaped tab extending between the free end 146 and the first portion 141. The tab 148 is preferably a highly visible color that contrasts with the sheath, such as white, and preferably includes a mark, such as a laser-cut arrow 150, indicating the direction in which the tab 148 of the protective strip should be pulled to peel the protective strip from the third portion and expose the adhesive (Figure 17). According to one embodiment of the system, the strip 140 is provided with at least one perforation 152 that allows for breakaway disassembly of the system after use (Figure 18).The perforations 152 are preferably provided at or near the joint between the second portion 142 and the third portion 144 of the tape.

[0063] Referring to Figures 8, 19, and 20, according to another aspect of the system, the cap assembly 50 is fitted to invert relative to the sheath 89 by an action from the proximal handle 24. The pull string 100 referred to above extends from the proximal handle 24 through the lumen 94 in the sheath 89 and exits from the distal end of the sheath. The pull string 100 described herein refers to a monofilament, multifilament, or cable twisted element of textile, polymer, or metal. There is a gap 154 ​​(Figure 8) between the distal end of the sheath and the end cap, through which the catheters 34, 36, the transmission assembly 42, and a portion of the pull string 100 are exposed to the outside of the sheath 89 and reach the cap assembly 50. The length of the gap 154 ​​generally represents the difference in length between the endoscope 12, which has a longer first length, and the sheath 89, which has a shorter second length. In a preferred embodiment, the exposed length of the gap 154 ​​is less than 16 cm, more preferably 6 to 12 cm, even more preferably 7.5 to 10 cm, and most preferably 8.5 cm, providing optimal retroflexion as described below. On the opposite side of the gap 154, the transmission assembly 42 is fixed in a lateral recess 85 of the cap assembly 50, and the catheters 34, 36 are fixed in the first and second through bores 86, 88 (as shown, for example, in Figure 9). Furthermore, the distal end 156 of the pull string 100 is fixed to the cap assembly 50. In one assembly, the distal end 156 is joined in a hole (not shown) at the proximal end of the cap assembly 50. The proximal end 158 of the pull string 100 exits the sheath, passes through the opening of the proximal handle 24, and is attached to the pull handle 160. The pull handle mount 162 is preferably formed on the proximal handle 24 and can secure the pull handle 160 by interference fit when not in use. A pull string lock 164 is provided on the proximal handle 24 to secure the pull string under tension. One example of an embodiment of the pull string lock 164 includes an elastic rubber washer 166 fixed on the seat 168 and on the post 170 (Figure 21).When it is desirable to invert the cap assembly 50 during use, the pull handle 160 can be released from the handle mount 162 and pulled to apply tension to the pull string 100. When tension is applied to the pull string 100, the pull string 100 retracts across the gap 154 ​​and through the lumen 94. When the pull string 100 is pulled across the gap 154, the cap assembly 150 inverts, as shown in Figure 22, to shorten the distance between the end of the sheath 89 and the position where the distal end 156 of the string is attached to the cap assembly 50. Once the desired degree of inversion is achieved, tension on the pull string 100 can be temporarily maintained (the inversion configuration is fixed) by wrapping the proximal end 158 of the pull string 100 around the post 170 between the washer 166 and the seat 168 (Figure 23). The compression of the pull string 100 between the washer 166 and the seat 168 holds the pull string in place. The pull handle 160 can be returned to the handle mount 162 so as not to interfere with the use of the proximal handle 24 and other features of the endoscope 12 (i.e., to the position shown in Figure 19). The reversal of the system may be used in combination with activating the reversal of the endoscope. When attempting to release the reversal state at the distal end, the proximal end 158 of the pull string 100 is unwound from the pull string lock 164, releasing the tension on the pull string. In this way, the reversal of the system acts as an aid to the system attached to the endoscope, ensuring that the reversal of the endoscope is performed completely as intended. It is also recognized that this type of reversal system can be used in different endoscopic treatment and intervention systems, with or without assistance from the endoscope, and is not limited to systems for suturing.

[0064] In light of the above, the suturing device may be prepared for use in conjunction with the endoscope as follows: The distal end 44 of the endoscope 12 is pushed into the elastic clip 104 until it seats on or near the distal stop 106 (Figure 10). The endoscope and cap assembly 50 are then rotated coaxially with each other until the instrument channel 13 of the endoscope is rotatably aligned with the index portion 112 at the distal stop 106, ensuring proper alignment between them (Figures 12 and 13). The endoscope 12 is then pushed in completely, if necessary, until it contacts the distal stop 106 (Figure 14).

[0065] Next, referring to Figures 24, 25, and 26, the loop 136 at the free end 134 of the first spool 128 of the tape applicator 124 engages with the distal first hook 120, and the handle 126 coupled to the spool 128 is operated to wrap the tape 129 over the most distal portion of the distal end 44 of the endoscope 12, over the clip 102, and wrap the back side of the tape 129 once or more in a circular motion (arrow 138) to secure the endoscope to the clip. Tension is applied to the tape during the wrapping. The relative diameter of the tape spool 128 and the endoscope 12 facilitates the application of significant tension to the tape while wrapping it around the endoscope. After the tape has been applied to the first hook 120, the depleted spool 128 is removed from the spool mount 132, and a new spool 128 of tape is mounted on the spool mount of the handle 126. Referring to Figures 27 and 28, the tape 129 from the new spool 128 is similarly applied across adjacent areas of the endoscope 12, starting from the second hook 122 until the distal end 44 of the endoscope 12 and the cap assembly 50 are both secured.

[0066] Next, referring to Figures 11, 17, 18, and 29, the endoscope is fully pushed into the recess 96 along the length of the sheath 89. Starting from the distal end of the system, on strip 140a of tape, the tab 148 of the protective strip is peeled off to expose the adhesive portion 144, and with tape 140 taut, the first portion 142 of the tape is wrapped around the endoscope 12, the second adhesive portion 144 of the tape is adhered to the sheath on the opposite side of the recess 96, and then extended again to cover the tape and secure the endoscope there. To properly secure the sheath to the endoscope, this process is repeated along the length of the sheath for the remaining strips 140c, and then 140b. This secures the sheath 89 longitudinally outside the endoscope 12 for in vivo operation.

[0067] The collar 28 is appropriately positioned on the proximal handle 45 of the endoscope 12. The first device, a needle capture instrument 38 loaded with a needle assembly 70, is advanced through the first port 32 into the first lumen 34 to the cap assembly 50. A preferred needle capture device 38 is described in detail in U.S. Patent No. 8,679,136, which is incorporated herein by reference in whole for all purposes. The needle assembly 70 is loaded on a needle arm 58, and the suture 78 extends parallel to the needle capture instrument 38 within the first lumen 34.

[0068] Referring to Figures 1 and 25, the distal end of the endoscope 12 and the cap assembly 50 of the suturing device 22 are optionally advanced through a guide tube (not shown) into the patient's natural orifice to approach the target tissue 180. At any point, if it is necessary to reorient the endoscope 12 by inversion, the cap assembly 50 can also be inverted, as described above, to assist and / or further direct the distal end of the endoscope and the cap assembly towards the intended target tissue. Once adjacent to the target tissue 180, the handle 24 of the suturing device 22 is operated to move the needle arm 58 to the open position, as shown in Figure 29. Referring to Figure 31, the end effector of the second device, e.g., a tissue retractor 40 having a helical coil 40a at its distal end, advances through the second port 32 into the second catheter 36 (Figure 8), exits the second through bore 88 (Figure 9), and advances beyond the cap assembly 50. A suitable tissue retractor is described in detail in U.S. Patent No. 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 is operated to engage with the target tissue 180. The tissue retractor 40 is retracted to bring the tissue 180 against the tissue guard 87 and pull it into the path of the needle assembly 70, i.e., into the tissue fold 182 located between the bracket 54 and the needle guide 87 as shown in Figure 32. The orientation of the second through bore 88 is parallel or angled to the first through bore 86 to guide the tissue retractor and engage with the tissue, pulling it into the needle path. The handle 24 is then operated to move the needle arm 58 to the closed position, thereby perforating the tissue fold 182 and passing the needle assembly 70 with the suture 78 through the tissue fold during movement (Figure 33). When the needle arm 58 is in the closed position, the needle is received within the distal end of the needle capture device 38 (Figure 9). The needle capture device 38 is operated to securely engage with the needle 70. The handle 24 is then operated to move the needle arm 58 toward the open position, thereby disengaging the needle arm 58 from the needle assembly 70, which remains within the needle capture device 38 (Figure 34).The tissue retractor 40 is also released from the tissue and withdrawn through the second catheter 36. Next, the endoscope 12 is moved to displace the cap assembly 50 relative to the tissue 184 to be sutured. The needle 70 and suture 78 may be secured to the tissue by knotting or tightening, or the needle may be repositioned on the needle arm, and additional suture loops may be formed in adjacent or other areas of the tissue. Once suturing is complete, the needle arm 58 is returned to the closed position, and the endoscope 12 and suturing device 22 are removed from the patient.

[0069] Next, the suture assembly is released from the endoscope by, for example, using scissors 190 to cut the two bands of tape 129 connected to hooks 120, 122 that secure the endoscope 12 to the cap assembly 50, and then by untying the tape 129 over the opening of the cap clip 102, as shown in both Figures 30 and 31. Next, referring to Figure 37, the tape strips 140b, 140c, and 140a are broken by applying force in the direction of arrow 174 to break each piece of tape at its perforations 152 (Figure 18). Since each tape strip is not directly attached to the endoscope but only to itself and the sheath 89, the endoscope can be released once the strips are broken. Next, the proximal handle 24 is completely released from the endoscope 12.

[0070] In view of the foregoing, according to various principles of the present disclosure, an example of an embodiment of an endoscopic device for use with an endoscope comprises 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 handle assembly defines a recess into 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 to receive a tension member that wraps around the cap assembly and a portion of the endoscope.

[0071] In some embodiments, at least one hook is identified by a color that is in contrast to the majority of the cap assembly. Incidentally or alternatively, in some embodiments, the distal cap assembly includes a distal stop portion intended to abut against the distal end of the endoscope. In some embodiments, the distal stop portion includes an index portion intended to align the feature portion of the endoscope with it in a rotational direction. In some embodiments, the index portion includes a color contrasting with the majority of the cap assembly. In some embodiments, the distal stop portion and the index portion on at least one hook are identified by a common color. In some embodiments, the feature portion of the endoscope to which the index portion is aligned is the instrument channel of the endoscope.

[0072] Incidentally or alternatively, in some embodiments, the cap assembly is a suture assembly including a movably mounted needle holder. In some embodiments, the operation of the proximal handle assembly moves the needle holder on the cap assembly.

[0073] According to various principles of this disclosure, an example of an embodiment of an endoscopic device for use with an endoscope 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 cap assembly defines a recess into which the distal end of the endoscope is received. Incidentally or alternatively, the cap assembly includes two longitudinally spaced hooks on one side of the recess.

[0074] Incidentally or alternatively, in some embodiments, each hook is identified by a color that contrasts with the majority of the cap assembly's color. Incidentally or alternatively, in some embodiments, each hook is identified by a different hook indicator. In some embodiments, the hook indicator indicates the sequence of operations in which the hook is intended to be used. In some embodiments, the hook indicator includes a number.

[0075] Incidentally or alternatively, in some embodiments, the distal cap assembly includes an elastic clip that defines a recess. Incidentally or alternatively, in some embodiments, the distal cap assembly includes a distal stop portion against which the distal end of the endoscope is intended to abut, the stop portion including a symmetrical alignment index portion against which the feature portion of the endoscope is intended to rotate and align.

[0076] Incidentally or alternatively, in some embodiments, the distal cap assembly includes a distal stop portion into which the distal end of the endoscope is intended to abut, the stop portion including a symmetrical alignment indicator portion into which the instrument channel of the endoscope is intended to rotate and align. In some embodiments, the distal stop portion includes first and second recesses, the alignment indicator portion being provided in the first recess.

[0077] In some embodiments, the cap assembly is a suture assembly that includes a movably mounted needle holder, and the operation of the proximal handle assembly moves the needle holder on the cap assembly.

[0078] According to various principles of this disclosure, an example of an embodiment of a fixation system for use with an endoscope includes an endoscopic device comprising a proximal handle assembly, a distal cap assembly, a central portion adapted to extend along the endoscope between the handle assembly and the cap assembly, and a spool of tape. In some embodiments, the distal cap assembly defines a recess into which the distal end of the endoscope is received, and a hook on the side of the recess. In some embodiments, the spool of tape has a free end with a pre-formed loop adapted to be received on the hook. In some embodiments, the loop is adapted to be attached on the hook. In some embodiments, the tape is wrapped around the cap assembly and a portion of the endoscope and adapted to connect the cap assembly and the endoscope to each other.

[0079] In some embodiments, the system further includes a tape applicator comprising a handle and an extension section having a spool mount. In some embodiments, the spool is connected to a spool mount. In some embodiments, the spool is removably connected to the spool mount.

[0080] In some embodiments, the cap assembly includes at least two longitudinally displaced hooks. In some embodiments, the fastening system includes at least two spools of tape.

[0081] In some embodiments, the hook is identified by a color that contrasts with the majority of the cap assembly's color. In some embodiments, the cap assembly includes at least two hooks. In some embodiments, each hook is identified by a different hook indicator. In some embodiments, the hook indicator identifies the sequence of operations in which the hook is intended to be used. In some embodiments, the hook indicator includes a color that is in contrast to the majority of the cap assembly.

[0082] In some embodiments, the cap assembly is a suture assembly that includes a movably mounted needle holder. In some embodiments, the operation of the proximal handle assembly moves the needle holder on the cap assembly.

[0083] According to various principles of the present disclosure, the method involves coupling a cap assembly of an endoscope device to an endoscope having a distal end. In some embodiments, the cap assembly defines a recess into which the distal end of the endoscope is received. Incidentally or alternatively, the cap assembly has first and second longitudinally displaced hooks on one side of the recess. According to various principles of the present disclosure, the method involves inserting the distal end of the endoscope into the recess, providing a tape of first length having a first loop at its free end, coupling the first loop to a first hook, and wrapping at least a portion of the tape of first length around the cap assembly and the distal end of the endoscope.

[0084] In some embodiments, the method further includes providing a tape of a second length having a second loop at its free end, connecting the second loop to a second hook, and wrapping at least a portion of the tape of the second length around the cap assembly and the distal end of the endoscope. In some embodiments, the first hook is displaced distally from the second hook. In some embodiments, the endoscope device includes a proximal handle and a central longitudinal sheath portion extending between the handle and the cap assembly. In some embodiments, the central longitudinal portion includes a concave recess along its length. In some embodiments, the method further includes inserting the endoscope into the recess of the central longitudinal sheath portion and securing the central longitudinal sheath portion to the endoscope. In some embodiments, the sheath portion is secured to the endoscope using a plurality of longitudinally spaced tape pieces positioned at least partially circumferentially with respect to the sheath portion and the endoscope. In some embodiments, the central longitudinal sheath portion is crescent-shaped and defines at least one lumen. In some embodiments, at least one lumen includes a first lumen through which a flexible first catheter extends to a cap assembly, and a second lumen through which a flexible second catheter extends to a cap assembly. In some embodiments, the cap assembly includes an actuation arm movably mounted thereon. In some embodiments, a central longitudinal sheath portion includes a third lumen through which the actuation assembly extends. In some embodiments, the actuation assembly is coupled between a proximal handle and an actuation arm and is adapted to move the actuation arm on the cap assembly in response to the movement of the proximal handle. In some embodiments, the endoscopic device includes a pull string having a proximal end and a distal end, the pull string extending from the proximal handle through the central longitudinal sheath portion and fixed to the cap assembly. In some embodiments, the proximal end of the pull string is retracted relative to the proximal handle, and the distal end of the pull string is tensioned to flex the first and second catheters and pull them in to invert the cap assembly.

[0085] In some embodiments, the cap assembly is a suture assembly that includes a movably mounted needle holder. According to various principles of this disclosure, an example of an embodiment of an endoscopic device for use with an endoscope includes a proximal handle assembly, a distal cap assembly, a sheath portion, and a fixation system. In some embodiments, the cap assembly defines an assembly for positioning adjacent to the distal end of the endoscope. In some embodiments, the sheath portion defines a longitudinal recess. In some embodiments, the sheath portion is adapted to extend along a portion of the outside of the endoscope between the handle assembly and the cap assembly. In some embodiments, the sheath portion is adapted to extend at least partially around the endoscope in the recess. In some embodiments, the recess has a first side and a second side. In some embodiments, the fixation system is configured to fix the central portion to the outside of the endoscope during in vivo operation of the endoscope. In some embodiments, the fixation system includes a plurality of longitudinally spaced lengths of tape pre-applied to the sheath portion on the first side of the recess. In some embodiments, at least some or each of the lengths of the tape has an adhesive first portion to which the tape is bonded to the sheath on a first side surface of the recess, and a non-adhesive second portion extending from the first portion. In some embodiments, at least some or each of the lengths of the tape has an adhesive third portion extending from the second portion and terminating at a free end.

[0086] In some embodiments, the fastening system further includes a removable non-adhesive protective strip over the third portion. In some embodiments, the protective strip extends within a tab having a free end that protrudes between the free end and the first portion.

[0087] Incidentally or alternatively, the protective strip extends within an L-shaped non-adhesive tab. Incidentally or alternatively, the tab has an indicator portion that shows the direction in which the tab should be pulled to expose a third portion.

[0088] Incidentally or alternatively, the protective strip has a color that contrasts with the sheath portion. In some embodiments, each length of tape has perforations between, at, or near the joints of the second and third portions of the tape.

[0089] In some embodiments, the fastening system includes a first-length tape pre-applied to the distal end of the sheath portion, a second-length tape pre-applied to the central portion of the sheath portion, and a third-length tape pre-applied to the sheath portion between the first-length tape and the second-length tape.

[0090] In some embodiments, the sheath portion defines at least one lumen in the wall of the sheath portion. In some embodiments, the cap assembly is a suture assembly that includes a movably mounted needle holder. In some embodiments, the operation of the proximal handle assembly moves the needle holder on the cap assembly.

[0091] According to various principles of this disclosure, a method for fixing an endoscopic device to an endoscope includes fixing an endoscope having an external sheath to the endoscope. In some embodiments, 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 and around at least a portion of the circumference of the endoscope. In some embodiments, the method includes providing a sheath with a pre-applied portion of tape along the second length, extending the sheath around a portion of the circumference of the endoscope along the first length, and fixing the sheath to the endoscope by wrapping the pre-applied portion of tape around the periphery of the endoscope and the sheath.

[0092] In some embodiments, at least one or each of the pre-applied portions of the tape includes an adhesive first portion to which the portion of the tape is adhered to the sheath. Incidentally or alternatively, at least one or each of the pre-applied portions of the tape includes a non-adhesive second portion extending from the first portion. Incidentally or alternatively, at least one or each of the pre-applied portions of the tape includes an adhesive third portion extending from the second portion and terminating at a free end. Incidentally or alternatively, at least one or each of the pre-applied portions of the tape includes a removable protective strip over the third portion. In some embodiments, the method further includes removing the removable protective strip from the other third portion, extending the second portion to contact the endoscope, and adhering the third portion to contact the sheath on the opposite side of the endoscope from the first portion.

[0093] In some embodiments, the sheath defines a recess, the endoscope is inserted into the recess, and the first and third portions of the tape are positioned on opposing sides of the recess. In some embodiments, each of the pre-applied portions of the tape includes perforations. In some embodiments, the method further includes releasing the endoscope from the sheath by applying force to break the tape at the perforations. In some embodiments, the tape is broken without cutting. In some embodiments, the tape is broken by applying a force parallel to the longitudinal axis of the endoscope. In some embodiments, the cap assembly is a suture assembly including a movably mounted needle holder.

[0094] According to various principles of this disclosure, an example of an embodiment of an endoscopic device for use with an endoscope includes a proximal handle assembly, a distal cap assembly, a sheath, a first catheter, a second catheter, and a transmission cable. In some embodiments, the distal cap assembly is adapted to be positioned adjacent to the distal end of the endoscope. In some embodiments, the cap assembly has a movable end effector thereon. In some embodiments, the sheath is a crescent-shaped flexible sheath. Incidentally or alternatively, the sheath has a longitudinal lateral opening recess sized to receive a portion of the endoscope between the handle assembly and the cap assembly. Incidentally or alternatively, the sheath defines a first lumen, a second lumen, and a third lumen. In some embodiments, the first catheter extends distally in the first lumen, beyond it to the cap assembly. In some embodiments, the second catheter extends distally in the second lumen, beyond it to the cap assembly. In some embodiments, the transmission cable extends from the handle assembly. In some embodiments, the transmission assembly extends from the handle assembly into a third lumen. In some embodiments, the transmission assembly extends distally beyond the third lumen to the cap assembly. In some embodiments, the transmission assembly is operably coupled to an end effector. In some embodiments, the operation of the handle assembly moves the transmission cable and operates the end effector.

[0095] In some embodiments, the cap assembly is a suture assembly, and the end effector is a needle holder. According to various principles of this disclosure, an example of an embodiment of an endoscopic device is configured for use with an endoscope having a proximal end, a 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 embodiments, the distal cap assembly defines an assembly for interacting with tissue. In some embodiments, the distal cap assembly is adapted to be positioned adjacent to the distal end of the endoscope. In some embodiments, the distal cap assembly includes a clip for receiving the distal end of the endoscope. In some embodiments, the distal cap assembly includes a stopper for restricting the distal movement of the endoscope. In some embodiments, the stopper has an index portion that rotates and aligns with respect to the feature portion of the endoscope so as to ensure proper orientation of the lens and instrument channel of the endoscope without interference from the stopper. In some embodiments, the central portion extends between the handle and the cap assembly.

[0096] In some embodiments, the stopper is adapted to work with endoscopes from multiple manufacturers. In some embodiments, the cap assembly is a suture assembly that includes a movably mounted needle holder. In some embodiments, the movement of the proximal handle moves the needle holder on the cap assembly.

[0097] According to various principles of this disclosure, an example of an embodiment of an endoscopic device for use with an endoscope includes a proximal handle assembly, a distal cap assembly, a sheath, at least one catheter, and a pull string. In some embodiments, the distal cap assembly is fitted to connect to the distal end of the endoscope, separated from the handle assembly by a first length. In some embodiments, the sheath is a flexible sheath. In some embodiments, the sheath has a proximal end and a distal end, the proximal end being attached to the handle assembly. In some embodiments, the sheath extends to a second length less than a first length. In some embodiments, the difference between the first and second lengths defines a gap. In some embodiments, the sheath is fitted to extend at least partially around the outside of the endoscope. In some embodiments, the sheath defines at least one lumen. In some embodiments, at least one catheter extends from the proximal end of the sheath through at least one lumen. In some embodiments, at least one catheter extends beyond the distal end of the sheath. In some embodiments, at least one catheter is fixed to the cap assembly. In some embodiments, the pull string has a proximal end and a distal end. In some embodiments, the pull string extends from the proximal end of the sheath, through at least one lumen, and out of the distal end of the sheath. In some embodiments, the distal end of the pull string is fixed to the cap assembly. In some embodiments, the proximal end of the pull string extends from an opening in the handle assembly. In some embodiments, when the proximal end of the pull string is retracted relative to the handle, the distal end of the pull string is pulled, bending the catheter and pulling the cap assembly inward across the gap.

[0098] In some embodiments, the distal cap assembly is a suture assembly that includes a movable needle for at least one catheter. In some embodiments, a pull string extends through a common lumen with a transmission cable for manipulating the suture assembly.

[0099] In some embodiments, the device includes a pull handle attached to the proximal end of the pull string. In some embodiments, the proximal handle assembly is adapted to retractably house the pull handle.

[0100] In some embodiments, the apparatus further includes a locking system for temporarily holding the pull string under tension. In some embodiments, the proximal handle assembly includes the locking system. In some embodiments, the locking system includes a post having a seat and a washer provided covering the post on the seat. In some embodiments, the proximal end of the pull string is held in place on the post. In some embodiments, the proximal end of the pull string is held in place on the post when it is wrapped around the post between the seat and the washer. In some embodiments, the washer is made of an elastic material.

[0101] According to various principles of this disclosure, an example of an embodiment of an endoscopic system includes an endoscope and an external instrument channel device that can be coupled to the endoscope. In some embodiments, the endoscope has a proximal end, a distal end, and an outer surface extending between the proximal and distal ends. In some embodiments, the proximal end has a first handle. In some embodiments, the distal end is adapted to invert when the proximal end is operated. In some embodiments, the instrument channel device has a second handle. In some embodiments, the instrument channel device has a sheath adapted to be coupled in close proximity to the outer surface of the endoscope between the proximal and distal ends. In some embodiments, the instrument channel device has a cap that is detachably coupled to the distal end of the endoscope. In some embodiments, the instrument channel device has an instrument channel extending from the distal end of the sheath to the cap. In some embodiments, the instrument channel device has a pull string extending from the second handle through the sheath and fixed to the cap. In some embodiments, when the pull string is subjected to tension, the cap is biased to an inverted position around the instrument channel.

[0102] In some embodiments, the cap is part of the suture assembly. In some embodiments, the system further includes a pull handle attached to the proximal end of the pull string. In some embodiments, the external instrument channel device includes a proximal handle assembly. In some embodiments, the proximal handle assembly is adapted to releasably house the pull handle.

[0103] In some embodiments, the system further includes a locking system for temporarily holding the pull string under tension. In some embodiments, the external device channel device includes a proximal handle assembly, the proximal handle assembly comprising a locking system. In some embodiments, the locking system includes a post having a seat and a washer provided covering the post on the seat. In some embodiments, the proximal end of the pull string is held in place on the post. In some embodiments, the proximal end of the pull string is held in place on the post when it is wrapped around the post between the seat and the washer.

[0104] The suturing assembly described above is adapted for use with endoscopes that do not necessarily have at least two instrument channels. Therefore, the suturing system is available in many surgical settings and can be used with smaller endoscopes that can be more easily advanced through natural orifices. In addition, as shown, embodiments of the system may be used in other surgical settings besides suturing.

[0105] This specification describes and illustrates embodiments of suturing systems, surgical treatment systems, and methods of using them. While specific embodiments of the present invention have been described, the invention is not intended to be limited thereto, and the invention is as broad as the scope permitted by the art, and this specification is intended to be read accordingly. Thus, while specific instruments and devices for advancing through first and second lumens are disclosed, it should be understood that other instruments may also be used through such lumens for similar or even different purposes. Furthermore, while the treatment system is described in particular with respect to a cap assembly having an end effector in the form of a needle arm for carrying a needle, it should be recognized that, as an alternative, one or more movable end effectors with other structures and purposes may be provided for the cap assembly. Also, while tissue anchors in the form of needle assemblies are described, the end effectors may accommodate different types of tissue anchors, such as clips. In addition, while specific needle assemblies have been described, other needle assemblies may be used in the same way. Furthermore, the size of the endoscope in which the system is used and the instrument channel features are not important. While various prior art systems cannot be properly used in suturing surgery with endoscopes having fewer than two instrument channels, one of which is for receiving a needle exchange device and the other for receiving a tissue retractor, it should be understood that the system of the present invention can operate fully without providing any channels through the endoscope. Moreover, although it is shown that the various features described herein are not limited to suturing applications such as inversion systems, it is specifically recognized that inversion systems can be used in conjunction with cap assemblies adapted to provide a variety of other surgical applications, including but not limited to staplers, clip applicators, band ligators, tissue manipulation instruments, cutting instruments, forceps, biopsy instruments, infusion devices, and cap assemblies that have no important function other than supporting an external catheter for the passage of instruments.Therefore, those skilled in the art will understand that further modifications can be made to the present invention without departing from the scope of the invention as described in the claims.

[0106] Those skilled in the art will understand that this discussion is merely a description of exemplary embodiments and is not intended to limit broader aspects of the present disclosure. All apparatus and methods discussed herein are examples of apparatus and / or methods implemented in accordance with one or more principles of this disclosure. These examples are merely illustrative and not the only ways of implementing these principles, and are not intended to limit the broader aspects of this disclosure. Accordingly, references to elements, structures, or features in the drawings should be recognized as references to examples of embodiments of this disclosure, and this disclosure should not be understood as limiting to the specific elements, structures, or features illustrated. Other examples of ways of implementing the disclosed principles will be apparent to those skilled in the art upon reading this disclosure. It should be obvious to those skilled in the art that modifications may be applied to the disclosed devices, systems, and / or methods, and / or sequences of steps of the methods described herein, without departing from the concepts, spirit, and scope of this disclosure. Various features described in relation to one embodiment will typically be applicable to another embodiment, whether expressly indicated or not. The various features described below may be used individually or in any combination thereof. Accordingly, the present invention is not limited to the embodiments specifically described herein, and all substitutions and modifications obvious 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 described above, various further advantages of the various aspects, features, components, and structures of the devices and systems described above may be understood by those skilled in the art.

[0107] The preceding discussions are presented for illustrative and explanatory purposes and have broad applicability, and are not intended to limit the disclosure to the forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concepts, spirit, and scope of the disclosure. In particular, it will be apparent to those skilled in the art that the principles of the disclosure may be embodied in other forms, structures, arrangements, proportions, and using other elements, materials, and components without departing from the concepts, spirit, scope, or features thereof. For example, various features of the disclosure have been combined into one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of the disclosure may be combined in alternative aspects, embodiments, or configurations. While the disclosure is presented with respect to embodiments, it should be understood that various distinct features of the subject matter of the application do not all need to be present in order to achieve at least some of the desired properties and / or advantages of the subject matter or such individual features. Those skilled in the art will understand that this disclosure can be used with many changes or modifications to the structure, arrangement, proportions, materials, components, and other elements used in the implementation of this disclosure, without departing from the principles, spirit, or scope of this disclosure, to be particularly suited to specific environmental and operating requirements. For example, an element shown as integrally formed may consist of multiple parts, an element shown as multiple parts may be integrally formed, the operation of an element may be reversed or otherwise changed, and the size or dimensions of an element may be changed. Similarly, while an operation or action or procedure is described in a particular order, this should not be understood as requiring such a particular order to achieve a desired result, or as meaning that all operations or actions or procedures should be performed. Furthermore, other forms of implementation are within the scope of the following claims. In some cases, the actions described in the claims may be performed in a different order and still achieve the desired result.Accordingly, the embodiments disclosed herein should be considered in all respects as illustrative and not limiting, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or specific embodiments or configurations described or illustrated herein. In view of the foregoing, individual features of any embodiment may be used and claimed separately or in combination with features of that embodiment or any other embodiment, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0108] In the foregoing description and the following claims, it will be understood that: The phrases “at least one,” “one or more,” and “and / or,” as used herein, are open-ended expressions that are both conjunctive and disjunctive in action. Terms such as “a,” “an,” “the,” “first,” and “second” do not exclude plurals. For example, the term “a” or “an” entity, as used herein, refers to one or more of those entities. Thus, the terms “a” (or “an”), “one or more,” and “at least one” can be used interchangeably herein. As used herein and in the appended claims, the term “or” is generally used to include “and / or,” unless the content clearly indicates otherwise. As used herein, the conjunction "and" includes each of the structures, components, features, etc. that are thus joined, unless the context explicitly indicates otherwise, and the conjunction "or" includes one or more of the structures, components, features, etc. that are thus joined, individually and in any combination and number, unless the context explicitly indicates otherwise. All references to directions (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or similar) are used solely for identification purposes to aid the reader's understanding of this disclosure and / or to distinguish areas of related elements from one another, and do not limit the elements relevant in particular with respect to the location, orientation, or use of this disclosure. References to connections (e.g., attached, joined, connected, engaged, joined, etc.) should be interpreted broadly and, unless otherwise indicated, may include intermediate members between sets of elements and relative motion between elements. Therefore, references to connections do not necessarily mean that two elements are directly connected and fixed to 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 one feature from another.

[0109] The following claims are incorporated by this reference into this detailed description, and each claim stands alone as a separate embodiment of the present disclosure. In the claims, the terms “comprises,” “comprising,” “includes,” and “including” do not exclude the existence of other elements, components, features, groups, areas, integers, steps, operations, etc. In addition, individual features may be included in different claims, but they may be advantageously combined in some cases, and inclusion in different claims does not mean that the combination of features is not feasible and / or unfavorable. In addition, singular references do not exclude plurals. Reference numerals in the claims are provided merely as examples for clarity and should not be construed as limiting the claims in any way.

Claims

1. A flexible tubular elongated member for use with an inversion system, wherein the flexible tubular elongated member is: The outer and inner surfaces extending between the proximal and distal ends of the flexible tubular elongated member, wherein the inner surface defines one or more lumens penetrating the flexible tubular elongated member between the proximal and distal ends, A flex section along the length of the flexible tubular elongated member between the proximal end and the distal end, the flex section configured to be kink-resistant and / or deformation-resistant, Equipped with, A flexible tubular elongated member, wherein at least one of the outer or inner surfaces of the deflection section is shaped, configured, and / or dimensioned to facilitate the deflection of the deflection section.

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

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

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

5. The flexible tubular elongated member according to claim 4, wherein the outer surface and the inner surface of the bending section are corrugated as a result of the shape of the wire coil between them.

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

7. The flexible tubular elongated member according to any one of claims 1 to 6, wherein the flexible section further comprises an outer tubular core layer covering the wire coil and an inner tubular core layer within the wire core, thereby forming a multilayer wall of the flexible section.

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

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

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

11. A system for inverting a flexible, elongated member of a medical device, wherein the system is: An elongated operating component that extends along the flexible elongated member and has a proximal end and a distal end, A distal mount configured to be attached to the distal end of the flexible elongated member, A pivot mount configured to be attached to the flexible elongated member at the proximal side of the distal mount, An auxiliary flexible tubular elongated member is configured to extend along the aforementioned flexible elongated member and has a proximal end and a distal end, Equipped with, The distal end of the auxiliary flexible tubular elongated member is operatively associated with the distal mount. The distal end of the operating component is operatively associated with the distal mount such that pulling the operating component proximal causes the distal end of the flexible elongated member to flex. When the operating component is pulled proximal to invert the flexible elongated member, the operating region of the operating component pivots with respect to the pivot mount. The auxiliary flexible tubular elongated member comprises a flexible section operatively associated with the distal mount such that it flexes when the operating component is pulled proximal, The aforementioned flexible section is configured to be kink-resistant and / or deformation-resistant when flexed. A system in which one or more lumens are defined through the flexible section and have a cross-sectional shape that is not affected by or changes due to the deflection of the flexible section.

12. The system according to claim 11 further comprises a flexible tubular elongated member having a proximal end and a distal end, with a lumen extending between them, The aforementioned operating component extends through the lumen of the flexible tubular elongated member, The flexible tubular elongated member is configured to be attached to the flexible elongated member such that the distal end of the flexible tubular elongated member is located 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 operating component, A system in which the auxiliary flexible tubular elongated member extends along the flexible tubular elongated member, and the flex section extends distally beyond the distal end of the flexible tubular elongated member so as to be operatively associated with the distal mount.

13. The system according to claim 12, wherein the flexible 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 through the flexible tubular elongated member.

15. A system according to any one of claims 11 to 14, The flexible section has an outer surface and an inner surface, the inner surface defining a lumen through the flexible section, A system in which at least one of the outer or inner surfaces of the deflection section is shaped, configured, and / or dimensioned to facilitate the deflection of the deflection section.

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