Devices, systems, and methods for joint movement and / or inversion of medical devices

Abstract

A system and device are provided for reversing a flexible, elongated medical component during in vivo use, in addition to existing medical devices.

Description

Technical Field

[0001] The present disclosure relates to devices, systems, and methods for effecting the inversion of medical devices. In some embodiments, the device and / or system may be attached to an existing medical device that can be maneuvered to effect an inversion or enhance an already provided inversion capability of the existing medical device.

Background Art

[0002] Various medical scopes include various mechanisms, such as internal pulleys and cables, to navigate the scope through the patient's body (including meandering body passages). For example, some medical scopes may articulate in one or more planes for vertical and / or lateral movement. Furthermore, various endoscopic devices (e.g., instruments, tools, etc.) and systems for performing surgical procedures or treatments are configured to be used with medical scopes such as existing endoscopes (e.g., commercially available endoscopes, or endoscopes not customized for devices or systems used with them). Medical scopes typically include one or more working channels through which one or more devices may be advanced to or retracted from a target site in the patient's body. Various endoscopic devices (sometimes referred to as Through-the-Scope, or "TTS" devices), designed to be delivered through the working channels of the scope, are guided to the target site in the patient by the flexion / articulation / bending of the scope. That is, once the target site is visualized by the manipulation of the scope, the endoscopic device is moved longitudinally through the working channels of the scope and advanced to the target site. Medical endoscopes may also include various mechanisms configured and positioned to articulate the distal end of the endoscope, for example, to direct devices extending through the work channel of the endoscope to a desired target site within the patient's body. However, the ability of the endoscope to flex may be limited by the limits of the endoscope's maximum deflection or by the degradation of the endoscope's performance over time. For example, the internal mechanisms of an endoscope used for navigation and articulation may wear down and / or the cables may stretch due to repeated use and resterilization, resulting in a degradation of performance over time. Furthermore, the added volume from various devices extending within or along the endoscope may also affect the articulation of the endoscope. There may be cases where the endoscope user can visualize the anatomical area they wish to reach, but the endoscope cannot articulate sufficiently to direct it towards the target site or to facilitate the advancement of other instruments to the target site.In some scope systems, additional devices and systems may be used in conjunction with the scope, adding volume to the overall system. During use, the scope may be difficult to manipulate as a result of constraints imposed by external systems coupled to it. Considering the various challenges in articulating the scope as desired during various procedures, the desired inversion may not always be achieved as easily as possible. This improvement may be useful in addressing these and other considerations. [Overview of the project] [Means for solving the problem]

[0003] 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.

[0004] A retroflexion device for retroflexing a flexible elongated member of a medical device is disclosed in accordance with various principles of this disclosure. The retroflexion device includes 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 elongated actuation component having a proximal end and a distal end, the length extending between them selected to extend along the length of the flexible elongated member. In some embodiments, the proximal end of the actuation component is controllable along the proximal end of the flexible elongated member, the distal end of the actuation component is operatively associated with the distal end of the flexible elongated member via the distal mount, and the actuation region of the actuation component pivots relative to the pivot mount when the actuation component is pulled proximal to retroflex the flexible elongated member.

[0005] In some embodiments, the inversion device further includes a flexible tubular elongated member having at least one lumen extending through it, and an actuation component extending through it. In some embodiments, the flexible tubular elongated member is configured to be mounted along the flexible elongated member. In some embodiments, the flexible tubular elongated member has a proximal end and a distal end defining a length between them that is shorter than the total length of the flexible elongated member, and the flexible tubular elongated member is configured to be mounted to the flexible elongated member with the distal end of the flexible tubular elongated member being proximal to the distal end of the flexible elongated member, the distal end of the flexible tubular elongated member forming a pivot mount for an actuation component. In some embodiments, the flexible tubular elongated member has two or more lumens extending through it to allow further devices to extend through the flexible tubular elongated member. In some embodiments, the flexible tubular elongated member has a proximal end and a distal end, and the inversion device further comprises a proximal mount provided along the proximal end of the flexible tubular elongated member, the proximal end of the actuation component being operably associated with the proximal mount.

[0006] In some embodiments, the reversing device further includes a proximal mount, the proximal end of the actuating component being operably associated with the proximal mount. In some embodiments, the reversing device further includes a pull handle on the proximal end of the actuating component. In some embodiments, the proximal mount includes a pull handle mount. In some embodiments, the reversing device further includes a locking system attached to the proximal mount and configured to temporarily hold the actuating component under tension to reverse a flexible elongated member.

[0007] In accordance with various principles of the present disclosure, the inversion system includes a medical device comprising: a flexible elongated member having a proximal end and a distal end and having an outer surface extending between the proximal and distal ends; a flexible tubular elongated member having a proximal end and a distal end and defining a lumen penetrating therebetween, and configured to be attached to the outer surface of the flexible elongated member; and an actuation component extending through the lumen of the flexible tubular elongated member and operably associated with the distal end of the flexible elongated member, the actuation component having a proximal end accessible to pull the actuation component proximally to invert the distal end of the flexible elongated member.

[0008] In some embodiments, the reversal system further includes a distal mount coupled to the distal end of a flexible elongated member, the distal end of which an actuation component is operably associated with the distal end of the flexible elongated member via the distal mount, and a pivot mount attached to the flexible elongated member proximal to the distal mount, the actuation region of which the actuation component pivots to reverse the distal end of the flexible elongated member. In some embodiments, the total length of the flexible tubular elongated member is less than the total length of the flexible elongated member, and the flexible tubular elongated member is attached to the flexible elongated member with its distal end proximal to the distal end of the flexible elongated member, the distal end of which defines the pivot mount.

[0009] In some embodiments, the reversal system further includes a proximal mount provided along the proximal end of a flexible elongated member and operably associated with the proximal end of the flexible elongated member. In some embodiments, the proximal end of the actuation component is operably associated with the proximal mount. In some embodiments, the reversal system further includes a pull handle at the proximal end of the actuation component, and the proximal mount includes a mount for the pull handle and a locking system configured to temporarily hold the actuation component under tension to reverse the flexible elongated member.

[0010] In some embodiments, the medical device is an endoscope. A method for inverting the distal end of a flexible elongated member of a medical device, according to various principles of the present disclosure, includes extending an elongated actuation component along the outside of the flexible elongated member; fixing the distal end of the actuation component to the distal end of the flexible elongated member; and pulling the actuation component proximal to pivot the actuation component around a pivot mount located proximal to the distal end of the actuation component and the distal end of the flexible elongated member, thereby inverting the flexible elongated member.

[0011] In some embodiments, pulling the actuation component includes pulling the proximal end of an actuation component adjacent to the proximal end of a flexible elongated member. In some embodiments, the method further includes fixing a portion of the actuation component to a locking system and holding the flexible elongated member in a retroflexed configuration.

[0012] In some embodiments, the method further includes inverting the distal end of the flexible elongated member by more than 180°. 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]

[0013] [Figure 1] This is a schematic diagram of an example of an embodiment of an inversion device system formed according to various principles of the present disclosure. [Figure 1A] This is a detailed view of the area enclosed by the circle in Figure 1. [Figure 2] This is a perspective view of an endoscopic suturing system according to one embodiment of the present invention. [Figure 3] Figure 2 is a proximal perspective view of the suturing device in the endoscopic suturing system. [Figure 4]FIG. 2 is a side view of the variable length suturing device of the endoscopic suturing system. [Figure 5] FIG. 3 is a distal perspective view of a cap assembly attached to the distal end of an endoscope of an endoscopic suturing system. [Figure 6] FIG. 4 is a distal perspective view of a cap assembly of a suturing device for an endoscope of an endoscopic suturing system. [Figure 7] FIG. 5 is a cross-sectional view taken along line VII-VII of FIG. 2. [Figure 8] FIG. 6 is a distal schematic view of a cap assembly of a suturing device for an endoscope of an endoscopic suturing system. [Figure 9] FIG. 7 is a view similar to FIG. 8, showing the endoscope rotated and aligned. [Figure 10] FIG. 8 is a view similar to FIG. 6, with the endoscope appropriately oriented and advanced. [Figure 11] FIG. 9 is a schematic view of a tape applicator. [Figure 12] FIG. 10 is a schematic view of a taping system for securing the sheath of a suturing device to an endoscope. [Figure 13] FIG. 11 is a view showing the characteristics of the tape of the tape system. [Figure 14] FIG. 12 is a view showing the characteristics of the tape of the tape system. [Figure 15] FIG. 13 is a schematic view of an inversion system for an endoscopic system as applied to the proximal handle of the system. [Figure 16] FIG. 14 is a schematic view of an inversion system for an endoscopic system as applied to the proximal handle of the system. [Figure 17] FIG. 15 is a schematic view of the details of one embodiment of a lock for an inversion system. [Figure 18] FIG. 16 is a schematic view of an endoscopic system receiving distal inversion applied by an inversion system. [Figure 19] FIG. 17 is a schematic view showing the details of the operation of the lock of FIG. 17. [Figure 20]The use of a tape applicator for applying tape to a cap assembly to secure the cap assembly to a distal end of an endoscope is shown. [Figure 21] The use of a tape applicator for applying tape to a cap assembly to secure the cap assembly to a distal end of an endoscope is shown. [Figure 22] The use of a tape applicator for applying tape to a cap assembly to secure the cap assembly to a distal end of an endoscope is shown. [Figure 23] The use of a tape applicator for applying tape to a cap assembly to secure the cap assembly to a distal end of an endoscope is shown. [Figure 24] The use of a tape applicator for applying tape to a cap assembly to secure the cap assembly to a distal end of an endoscope is shown. [Figure 25] The use of tape along a sheath for securing the sheath to an endoscope is shown. [Figure 26] The use of an endoscope system for endoscopically suturing tissue is shown. [Figure 27] The use of an endoscope system for endoscopically suturing tissue is shown. [Figure 28] The use of an endoscope system for endoscopically suturing tissue is shown. [Figure 29] The use of an endoscope system for endoscopically suturing tissue is shown. [Figure 30] The use of an endoscope system for endoscopically suturing tissue is shown. [Figure 31] The disassembly of tape from around a cap assembly is shown. [Figure 32] The disassembly of tape from around a cap assembly is shown. [Figure 33] The disassembly of a sheath from an endoscope is shown. [Figure 34] Examples of alignment of a cap assembly as in FIGS. 8 and 9 are shown. [Figure 35] Figures 8 and 9 show examples of alignment of the cap assembly. [Modes for carrying out the invention]

[0014] 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.

[0015] 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.

[0016] 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.

[0017] 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.).

[0018] In accordance with the various principles of this disclosure, inversion devices and systems are configured to be attached to a flexible elongated member for articulating and inverting the said flexible elongated member. It should be understood that terms such as engage, accept, attach, combine, connect, adhere, associate, and operably associate, including other grammatical forms, may be used interchangeably herein without limitation unless otherwise indicated. It should be further understood that, as used herein, retroflexion (including its various grammatical forms) is intended to refer to increased flexibility and bending of a device, for example, bending such a device backward, for example, beyond 90° from its initial direction. In other words, the distal end of a device extending substantially longitudinally may extend distally but be inverted to extend proximal. The increased flexibility and expanded range of joint movement that can be achieved by flexible elongated members with the help of inversion devices and systems formed according to the various principles of this disclosure improve access to anatomical sites within the body, particularly during transtubal and / or endoscopic procedures that provide minimally invasive access to the patient's body (i.e., without surgically incising the patient's body). Furthermore, inversion devices and systems formed according to the various principles of this disclosure impart to the associated flexible elongated members the ability to invert in a manner that cannot be achieved by any other means. The expanded range of joint movement, including the ability to invert, allows the flexible elongated member to provide improved access to the patient's anatomical structures than has ever been given or achieved by conventional devices and systems. The flexible elongated member may be a flexible elongated member of a medical scope (e.g., a member or component of a medical scope inserted into a patient, such as an insertion member or insertion tube of a medical scope), and / or a member of another medical device that is inverted within the patient, and this disclosure is not limited in this respect.

[0019] In some embodiments, inversion devices and systems formed according to various principles of the present disclosure are associated with a flexible elongated member in a manner that enables the inversion device and system to articulate and invert the distal end of the flexible elongated member. The device may be mounted to the flexible elongated member as part of a system that includes further components, including, but not limited to, various mounts. The mounts include, but not limited to, a mount configured to associate the inversion device and the flexible elongated member, a mount configured to hold a user engagement component of the inversion device, and a mount configured to guide the actuation component of the inversion device. In some embodiments, the inversion system includes an auxiliary flexible elongated member defining a lumen, through which at least the actuation component of the inversion device extends along the medical device so as to be flexed by the inversion device. The auxiliary flexible elongated member may define further lumens, for example, to provide an auxiliary working channel that complements the working channel of the flexible elongated member to which the inversion device and system are associated.

[0020] In some embodiments, a reversing device formed according to various principles of this disclosure is associated with a flexible elongated member having a steering system that allows at least a portion of the flexible elongated member to articulate. For example, the reversing device may be configured to be associated with a medical scope that is steerable and articulate independently of the reversing device. A reversing device formed according to various principles of this disclosure can assist, complement, modify, or increase the articulation capability of the flexible elongated member. By being formed independently of the medical scope, the reversing device can move independently of the medical scope and thus effectively eliminate the effects of variability in the articulation of the medical scope (e.g., based on manufacturing specifications, wear, or other modifications to function that may occur with repeated use). Reversing devices and systems formed according to various principles of this disclosure enable the associated flexible elongated member to achieve more consistent flexing and / or greater degrees of flexing than has been previously achievable.

[0021] Herein, various embodiments of devices and / or systems for bringing about the inversion of medical devices, as well as related methods, are described with reference to examples 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 characteristics 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 characteristic, or that an embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations thereof. It should be understood that one or more of the features, structures, concepts, and / or characteristics described with reference to one embodiment may be combined with one or more of the features, structures, concepts, and / or characteristics of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or characteristics described herein may be mixed and adapted to create a hybrid embodiment, and such hybrid embodiment is 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. Accordingly, 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 characteristics, 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 those skilled in the art should understand that they 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 any broader aspects of this disclosure.

[0022] 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 operably associated with a flexible elongated member 1100. The inversion device 1010 includes an elongated actuation component 1012 which may, for convenience and without intent to limit herein, be referred to as a pull string 1012. The pull string 1012 is an elongated element having a length selected to extend along the associated flexible elongated member 1100. Furthermore, the pull string 1012 is actuated from its proximal end 1012p and selected to have sufficient strength at its distal end 1012d to actuate the flexible elongated member 1100 with which the inversion device 1010 operably associated. The pull string 1012 may be formed from a woven fabric, polymer, or metal monofilament, multifilament, cable twist element, etc., having appropriate strength, selected with reference to its longitudinal range, the flexibility of the flexible elongated member 1100, etc. This disclosure is not limited to a specific 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 this disclosure. 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 non-limitingly refers simply to a flexible elongated member. Articulation and / or inversion of the flexible elongated member 1100 by the inversion system 1000 of this disclosure can favorably direct the distal working end, or the opening of the working channel (e.g., 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.

[0023] In accordance with 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 a 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 1012 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 convex section (e.g., the outer / external surface) of the flexible elongated member 1100. Alternatively, the distal mount 1020 may be a collar that surrounds the flexible elongated member 1100 and can be attached to it (e.g., fastened, bonded, clamped thereto). Other configurations or forms of mounts are within the scope and spirit of the disclosure, and the disclosure is not limited thereto.

[0024] In some embodiments, the distal mount 1020 may include one or more alignment features that are structured, formed, molded, positioned, or otherwise positioned to facilitate longitudinal and / or rotational alignment of the distal mount 1020 with respect to the flexible elongated member 1100. In some embodiments, the alignment features include a structure to which the user can be guided when rotating and oriented the system 1000 with respect to the flexible elongated member 1100. In some embodiments, the structure is formed around the circumference of the distal mount 1020. In some embodiments, the structure is sized, molded, configured, and / or dimensioned to position relative to the features of the flexible elongated member 1100, not only to facilitate orientation of the distal mount 1020 with respect to the flexible elongated member 1100, but also to allow clearance for the function of one or more features of the flexible elongated member 1100. In some embodiments, the distal mount 1020 is an end cap configured to be attached to the distal end of an endoscope. In some embodiments, the distal mount 1020 in the form of an end cap includes an indicia for alignment with the endoscope so as not to interfere with various functions or features of the endoscope, such as the optical system or its working channel.

[0025] In an example of the embodiment shown in Figure 1, the distal end 1012d of the pull string 1012 is operably associated with the flexible elongated member 1010 via the distal mount 1020. In some embodiments, the distal end 1012d of the pull string 1012 is operably associated with the distal mount 1020, such as being coupled (e.g., fixedly coupled) to it, and as a result, when the pull string 1012 is pulled proximal (e.g., by pulling its proximal end 1012p), the distal end 1012d pulls the distal mount 1020 proximal, causing the flexible elongated member 1100 to bend proximal (e.g., in the direction of the illustrated bending arrow F). To flex the flexible elongated member 1100 (e.g., its distal end 1100d), the working region 1012a of the pull string 1012, located proximal to the distal end 1012d, is held (e.g., fixed) against lateral 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 inversion system 1000.

[0026] In some embodiments, the working region 1012a of the pull string 1012 is held against lateral movement with the help of a pivot mount to facilitate proximal pulling of its distal end 1012d and cause deflection of the associated flexible elongated member 1100. More specifically, the pivot mount is attached to the flexible elongated member 1100 to provide a pivot point for the working region 1012a, so that pulling the distal end 1012d of the pull string 1012 proximal causes the pull string 1012 to pivot around the working region 1012a, and the pivot mount allows the distal end 1012d of the pull string 1012 to move proximal by causing the pull string 1012 to flex proximal to the associated flexible elongated member 1100 in an operable manner. In some embodiments, the lateral movement of the working region 1012a of the pull string 1012 can be restricted using a pivot mount similar to the distal mount 1020 described above. For brevity, and without any intention of limitation, please refer to the above description of the mount. It will be understood that the axial position of the pivot mount (e.g., along the longitudinal extension of the inversion system 1000) may be modified to achieve the desired deflection of the distal end 1001d of the inversion system 1000 (and / or its components). In some embodiments, care should be taken when selecting the position of the pivot mount relative to the distal end 1000d (and / or its deflected element) of the inversion system 1000 so as to limit the exposed portion of the pull string 1012 (from its fixed portion on the distal mount 1020 to the proximal position of the pivot mount) (e.g., to reduce the possibility of the pull string 1012 coming into contact with patient tissue within the area of ​​the target site).

[0027] In some embodiments, the pivot mount that holds the working area 1012a of the pull string 1012 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 translationally / movably. 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. In some embodiments, the flexible tubular elongated member 1030 includes a flexible elongated member 1100 engagement section that facilitates engagement between the flexible tubular elongated member 1030 and the flexible elongated member 1100, and remains positioned relative to each other, for example, while moving through an anatomical passage. In some embodiments, the engagement section includes a concave recess that is sized, molded, configured, and / or dimensioned to facilitate the mounting of a flexible tubular elongated member 1030 onto a flexible elongated member 1100. For example, the concave recess may be sized, molded, configured, and / or dimensioned so that the flexible tubular elongated member 1030 can extend close to the outside of the flexible elongated member 1100. For example, the curvature of the concave recess may be selected to fit against and / or receive the outside of any of various commercially available endoscopes. In some embodiments, the concave recess may extend more than 180° around the circumference of the flexible elongated member 1100, thereby partially enclosing its outside. In some embodiments, the concave recess extends along a portion of the entire length of the flexible tubular elongated member 1030, or substantially along the entire length of the flexible tubular elongated member 1030, for example, to facilitate the navigation of the flexible elongated member 1100 together with the system 1000 mounted thereon.

[0028] In some embodiments, the flexible tubular elongated member 1030 does not extend along the entire length of the flexible elongated member 1100 (for example, the length of the flexible tubular elongated member 1030 is less than the length of the flexible elongated member 1100) in order to enable the operation of the pull string 1012 and to provide the extent to which the pulling of the pull string 1012 on the flexible elongated member 1100 causes the flexible elongated member 1100 to bend. As shown in Figure 1, the distal end 1030dm of an example embodiment of the flexible tubular elongated member 1030 is located 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 most distal end 1030dm of the flexible tubular elongated member 1030, and is operably associated with the distal end 1100d of the flexible elongated member 1100. Thus, in some embodiments, the most distal end 1030dm of the flexible tubular elongated member 1030 may provide an anchor or pivot point for the working region 1012a of the pull string 1012, for example by acting as a pivot mount, and 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.

[0029] As can be understood in consideration of the foregoing, various concepts of this disclosure may be applied to one or more devices, such as devices used in combination with or independently of the flexible elongated member 1100. This may enable further articulation, additional flexibility, and / or reachability, which may in some cases be achieved independently of other devices in the system. Additional devices may extend along the outside of the flexible elongated member 1100, along the inversion device 1010, or through a lumen through the flexible tubular elongated member 1030, through which the pull string 1012 of the inversion device 1010 extends. Incidentally or alternatively, additional devices may extend through a lumen defined through the flexible elongated member 1100, such as through the working channel of the flexible elongated member 1100 in the form of a medical scope, with which the inversion system 1000 is associated.

[0030] In some embodiments, two or more actuation components may be provided, formed according to the various principles of the present disclosure as described above. Each of the additional actuation components may operate in a manner similar to the function of the pull string 1012 described above. Optionally, each of the additional actuation components may operate in a direction different from the direction in which the pull string 1012 operates. For example, if a second pull string is added to deflect the distal section of one or more components of the inversion system 1000 in the opposite direction to the deflection described above (as illustrated in Figure 1), the second pull string would have an operating range located at a different circumferential position relative to the distal end 1000d of the inversion system 1000, such as on the opposite side (180° from) the position of the operating region 1012a of the pull string 1012 described above. The proximal ends of one or more actuation components of the inversion system 1000 may be terminated separately, or they may be connected together (e.g., a "pulley"). When one of the actuarial components is pulled proximal, the other actuarial component does not need to be actuated (for example, it may be in a nearly relaxed state).

[0031] When a reversal system 1000 formed according to various principles of this disclosure is used with a flexible elongated member 1100 in the form of a medical scope, the reversal system 1000 can add further degrees of freedom of movement to an existing medical scope, thereby enhancing the articular movement and / or reversal of the medical scope and / or any instrument used with it (e.g., one that is advanced through its working channel or otherwise operably associated with the medical scope). For example, in some embodiments, a reversal system 1000 formed according to various principles of this disclosure allows a flexible elongated member 1100 operably associated with it to bend to an angle greater than about 90°, for example greater than about 145°, greater than about 180°, and even at least about 210° or beyond (including various increments in between, such as in 1° increments). It will be understood that the range of reversal may be partially limited by the arrangement of the pull string 1012 and / or other components of the reversal system 1000 relative to the flexible elongated member 1100. This is because it may interfere with the relative movement and positioning of the deflected portion of the inversion system 1000 and the proximal portion of the flexible elongated member 1100. In some embodiments, the pull string 1012 may be adjusted to cooperate with the inversion system 1000 to restore the full maneuverability of the inversion system 1000 while preventing excessive stretching or excessive deflection of the movement that was not designed by the manufacturer of the inversion system 1000.

[0032] As can be understood, as the distal portions 1000d, 1100d of the inversion system 1000 and the flexible elongated members 1100 are inverted, such distal portions 1000d, 1100d move closer to the proximal portions of the inversion system 1000 and the flexible elongated members 1100 than to their bent portions. However, various properties of the inversion system 1000 and the flexible elongated members 1100 (or at least their distal portions 1000d, 1100d), such as stiffness, elasticity, and flexibility, typically generate a bending radius that separates the distal portions 1000d, 1100d of the inversion system 1000 and the flexible elongated members 1100 from their proximal portions when the inversion system 1000 and the flexible elongated members 1100 are inverted. Such separation typically prevents portions of the inversion system 1000 and the flexible elongated member 1100 that are close to the distal portions 1000d and 1100d from physically obstructing the inversion, thus allowing the distal portions 1000d and 1100d to be inverted by more than 180°. In some embodiments, the distal portions 1000d and 1100d of the inversion system 1000 and the flexible elongated member 1100 can be inverted by more than 180°, and even as much as 210°, before contacting the inversion system 1000 and the portions of the flexible elongated member 1100 that are proximal to it. Such inversions are greater than those previously achievable with existing devices, allowing the flexible elongated member 1100 to access a wider range of target sites. It will be understood that the more the distal portions 1000d, 1100d of the inversion system 1000 and the flexible elongated member 1100 are bent closer toward the proximal portions of the inversion system 1000 and the flexible elongated member 1100, the more the most distal ends of the inversion system 1000 and the flexible elongated member 1100 face the proximal portions, and the more the proximal portions may interfere with the use of the distal portions 1000d, 1100d.

[0033] In some embodiments, such inversion allows access to a target site that is not along the anatomical passage into which the flexible elongated member 1100 is inserted (e.g., distal to the insertion path of the flexible elongated member 1100 or otherwise not longitudinal). More specifically, if the flexible elongated member 1100 is inserted in a first direction through an anatomical passage or structure and the target site is not aligned with that first direction (e.g., positioned at 45° or 90° or more from the insertion or advancement path or direction of the flexible elongated member 1100), the distal end 1100d of the flexible elongated member 1100 must bend to access the target site, but various constraints in conventional systems and devices have prevented achieving the required bending angle. For example, when medical professionals access the fundus of a patient's stomach using an endoscope inserted through the patient's mouth and esophagus, they have faced difficulties because the fundus is located laterally to the lower esophageal sphincter. In some embodiments, the patient's esophagus does not allow significant lateral movement of the flexible elongated member 1100 for access to a target site such as the fundus. Systems 1000 and inversion devices 1010 formed according to various principles of this disclosure enable access to previously difficult-to-access target sites, such as the patient's fundus. Thus, various procedures, such as GERD repair in the fundus region, which were difficult, if not impossible, to perform endoscopically, transluminally, etc., become possible. For example, an inversion system 1000 formed according to various principles of this disclosure allows for sufficient inversion so that when advanced through the patient's esophagus into the patient's stomach, the distal end 1000d of the inversion component of system 1000 can be sufficiently inverted in a direction substantially aligned with the gastric cardia / fundus. Procedures in such areas of the stomach that were previously difficult to perform, such as GERD repair, can be performed using the inversion component of the inversion system 1000 of this disclosure.

[0034] In embodiments of the inversion system 1000, where the pull string 1012 extends along / through a flexible tubular elongated member 1030, the flexible tubular elongated member 1030 may optionally include additional longitudinally extending lumens through it. For example, in some embodiments, the flexible tubular elongated member 1030 may define auxiliary working channels to complement one or more lumens / working channels through the flexible elongated member 1100 on which the inversion system 1000 operates. Such auxiliary working channels may optionally enable the use of additional devices with the flexible elongated member 1100 and / or the inversion system 1000 in conjunction with the inversion device 1010 of the present disclosure. In some embodiments, the inversion device 1010 formed according to various principles of the present disclosure can articulate the flexible elongated member 1100 (e.g., its distal end) to orient the device toward or extending from its distal end 1100d, as well as facilitate the navigation of additional devices used in conjunction with the flexible elongated member 1100 and / or the inversion system 1000. In some embodiments, the forward, backward, insertion, etc., of additional devices with the flexible elongated member 1100 would add bulk to the flexible elongated member 1100 and / or the entire system. The inversion system 1000 and device 1100 of the present disclosure provide an independent bending system and are designed to address such challenges and overcome the resistance to bending that may be increased by using additional devices with the flexible elongated member 1100.

[0035] In some embodiments, it may be desirable to provide greater articulation of a device used in combination with a flexible elongated member 1100 (e.g., a medical scope) than is achievable with the flexible elongated member 1100 alone (e.g., articulation by using an articulation system provided with a medical scope, even when the scope is new). In some embodiments, a reversal device 1010 or reversal system 1000 formed according to various principles of this disclosure may be individually / separately operably associated with other flexible elongated members, such as other tools, instruments, or other elongated components, such as when used with the flexible elongated member 1100 and / or reversal system 1000 as described herein. Reversal devices 1010 and systems 1000 formed according to various principles of this disclosure provide greater articulation than was previously achievable by existing articulation systems of existing medical scopes, etc.

[0036] It will be understood that the statement that the pull string 1012 is pulled proximally to activate the operating region 1012a of the pull string 1012 does not necessarily have to be in a proximal direction relative to the inversion system 1000. Rather, such a proximal pull may refer to a proximal pull of the pull string 1012 in a broader sense, such as moving the portion of the pull string 1012 extending along the flexible elongated member 1200 in a proximal direction. The specific direction in which the proximal end 1012p of the pull string 1012 is pulled may be influenced by the manner in which the proximal end 1012p of the pull string 1012 is operably associated with the proximal end 1030p of the flexible tubular elongated member 1030. As described above, the pull string 1012 of the inversion system 1000 formed according to the various principles of the present invention is accessible along its proximal end 1012p (at or adjacent to the proximal end). For example, the pull string 1012 extends from the actuation section along its distal end 1012d (and along the distal end 1100d of the flexible elongated member 1100 that the pull string 1012 acts upon), and is accessible along its proximal end 1012p.

[0037] In an example of the embodiment shown in Figure 1, the proximal end 1012p of the pull string 1012 is operably associated with an adapter / proximal mount 1022 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. In some embodiments, the proximal mount 1022 is configured to facilitate the advance of the device through the lumen defined within the flexible tubular elongated member 1030, for example, by providing ports 1023, 1025 that facilitate access to the lumen defined through the flexible tubular elongated member 1030. In some embodiments, the proximal mount 1022 is configured to operably associate with the proximal end of the flexible elongated member 1100. For example, a bracket or other mounting device may be provided to attach the proximal mount 1022 to the proximal end of the flexible elongated member 1100, such as to the handle of the flexible elongated member 1100.

[0038] In some embodiments, the proximal end 1012p of the pull string 1012 extends along the flexible elongated member 1100 through the proximal mount 1022. In such a manner, the proximal mount 1022 can support a portion of the pull string 1012 along its proximal end 1012p relative to the flexible elongated member 1100, etc. The positioning of the proximal end 1012p of the pull string 1012 in or along the proximal mount 1022 facilitates control of both the flexible tubular elongated member 1030 and any associated devices (e.g., extending through or along it), as well as control of the pull string 1012 at a similar location along the inversion system 1000.

[0039] Depending on the position and orientation of the proximal mount 1022 relative to the flexible elongated member 1100, and how the pull string 1012 is associated with the proximal mount 1022, the proximal end 1102p of the pull string 1102 may be pulled axially or laterally with respect to the longitudinal extension of the flexible elongated member 1100 and the section of the pull string 1012 that extends along it to the distal end 1010d of the inversion device 1010. In an example of the embodiment shown in Figure 1, the pull string 1012 extends through the proximal mount 1022 such that the proximal end 1012p of the pull string 1012 extends laterally from the proximal mount 1022 with respect to the longitudinal range of the rest of the pull string 1012 (extending distally to the distal end 1010d of the inversion device 1010). Therefore, by pulling the proximal end 1012p of the pull string 1012 substantially laterally (for example, in the direction of the pull arrow P) relative to the longitudinal extension of the inversion system 1000, the pull string 1012 moves proximal, thereby causing the inversion of the flexible elongated member 1100 to which the inversion device 1010 is operably associated.

[0040] In an example of the embodiment shown in Figure 1, the pull string 1012 includes a user engagement component, such as a pull handle 1014, at its proximal end 1012p. The pull handle 1014 is sized, molded, constructed, and / or dimensioned to facilitate the user's engagement of the proximal end 1012p of the pull string 1012. In some embodiments, the pull handle 1104 is configured to allow a firm grip on the pull string 1102 and sufficient tensile force to produce the desired reversal. For example, the pull handle 1104 may extend substantially laterally with respect to the longitudinal extension of the pull string 1102.

[0041] In some embodiments, the inversion system 1000 includes a mount 1024 for the pull handle 1014 of the pull string 1012. The pull handle mount 1024 engages with the pull handle 1014 to hold it in place and is sized, shaped, configured, and / or dimensional such that the pull handle 1014 does not move so as not to cause the flexible elongated member 1100 to bend. For example, the pull handle mount 1024 can engage with the pull handle 1014 via an interference fit or a friction fit. Optionally, the pull handle mount 1024 may be provided on a proximal mount 1022 of the inversion system 1000. Thus, the pull handle 1014 is held in a position available at approximately the same location as other devices that can be operated with respect to the flexible elongated member 1100 and / or the flexible tubular elongated member 1030 at the proximal end 1000p of the inversion system 1000. The pull handle 1014 may be engaged with the pull handle mount 1024 while other features of the reversing system 1000 are in use.

[0042] In some embodiments, the inversion system 1000 includes a locking system including a pull string lock 1026 configured to operably engage with a portion of the pull string 1012, for example, to fix the pull string 1012 under tension. An example of an embodiment of the pull string lock 1026 is shown in detail in Figures 1 and 1A, and is in the form of a post or other elongated element that can wrap around or otherwise secure the pull string 1012. However, it will be understood that the present disclosure does not need to be limited by the configuration of the pull string lock 1026. When the pull string 1012 is pulled in the proximal direction and a desired degree of inversion of the flexible elongated member 1100 is achieved, the tension of the pull string 1012 can be temporarily maintained (and the inversion configuration can be fixed) by wrapping the proximal end 1012p of the pull string 1012 around the pull string lock 1026. In some embodiments, the pull string lock 1026 includes a locking structure 1028, such as an element that assists in holding (e.g., tightly winding) the pull string 1012 against the pull string lock 1026. In some embodiments, the locking structure 1028 is formed to provide an interlocking or frictional engagement of the pull string 1012 with respect to the pull string lock 1026. For example, the locking structure 1028 may be an element that frictionally engages with the pull string 1012, such as an elastic rubber washer that covers the pull string lock 1026 and is fixed to it (and optionally on a seat formed on the pull string lock 1026), as illustrated in more detail in the detail drawing provided in Figure 1A. Once the desired inversion of the flexible elongated member 1100 is achieved, the tension of the pull string 1012 can be maintained by wrapping the proximal end 1012p of the pull string 1012 around the pull string lock 1026 between the lock structure 1028 and the structure in which the pull string lock 1026 is provided, between the lock structure 1028 and the seat 1027 on the pull string lock 1026.In some embodiments, compression of the pull string 1012 between the locking structure 1028 and the seat portion 1027 holds the pull string 1012 in place relative to the pull string lock 1026.

[0043] In one illustrated embodiment, the pull string lock 1026 is mounted on / extends from the proximal mount 1022 of the reversing system 1000. In some embodiments, the pull string lock 1026 may be positioned close enough to the pull handle mount 1024 to facilitate the convenient attachment of the pull handle 1014 to the pull handle mount 1024, even after it has been released from the pull string lock 1026 or, optionally, when the proximal end 1012p of the pull string 1012 has been wrapped around the pull string lock 1026.

[0044] 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, which extends externally / outward along / beside the actuated device or system, applies a tangential force that can apply a greater force to the device or system than the force applied by the actuating element extending through it (inward rather than outward).

[0045] 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.

[0046] Referring to Figures 2 to 5, 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 4). 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.

[0047] The suturing system 21 includes a suturing device 22 (Figure 3), a needle assembly 70 (Figure 5) that can move through tissue by the suturing device 22, and first and second devices 38, 40 (Figure 5) used in conjunction with the suturing device 22.

[0048] Referring to Figures 2, 3, and 4, 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.

[0049] Referring to Figures 3, 4, and 7, 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.

[0050] 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.

[0051] Referring to Figure 5, 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.

[0052] 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.

[0053] Referring to Figures 5 and 6, 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.

[0054] Referring to Figures 4 and 7, 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 (i.e., 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.

[0055] Referring to Figures 4 and 5, 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.

[0056] Referring to Figure 6, 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.

[0057] Referring to Figures 6, 8, 9, and 10, 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.

[0058] Referring to Figure 10, 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.

[0059] Referring to Figure 11, 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.

[0060] Referring here to Figures 12, 13, and 14, 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 13). 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 14).The perforations 152 are preferably provided at or near the joint between the second portion 142 and the third portion 144 of the tape.

[0061] Referring to Figures 4, 15, and 16, 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 4) 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 5). 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 17).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 18, 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 19). 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 15). 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.

[0062] 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 6). 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 8 and 9). The endoscope 12 is then pushed in completely, if necessary, until it contacts the distal stop 106 (Figure 10).

[0063] Next, referring to Figures 19, 20, and 21, 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 23 and 24, 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.

[0064] Next, referring to Figures 7, 13, 14, and 25, 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 the 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.

[0065] 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.

[0066] Referring to Figures 2 and 26, 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 25. Referring to Figure 27, 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 4), exits the second through bore 88 (Figure 5), 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 28. 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 29). 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 5). 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 30).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.

[0067] 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 untying the tape 129 over the opening of the cap clip 102, as shown in both Figures 31 and 32. Next, referring to Figure 33, 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 14), and 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] 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.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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. An inversion device for inverting a flexible, elongated member of a medical device, wherein the inversion device is: A distal mount configured to be attached to the distal end of the aforementioned flexible elongated member, A pivot mount configured to be attached to the flexible elongated member at the proximal side of the distal mount, An elongated actuation component having a proximal end and a distal end, wherein the length extending between them is selected to extend along the length of the flexible elongated member, Equipped with, The proximal end of the operating component is controllable along the proximal end of the flexible elongated member. The distal end of the operating component is operably associated with the distal end of the flexible elongated member via the distal mount. The operating region of the operating component is a reversing device that pivots relative to the pivot mount when the operating component is pulled proximally and reverses the flexible elongated member.

2. The reversing device according to claim 1, further comprising a flexible tubular elongated member, the flexible tubular elongated member having at least one lumen extending through the flexible tubular elongated member, and the operating component extending through the lumen.

3. The inversion device according to claim 2, wherein the flexible tubular elongated member is configured to be attached along the flexible elongated member.

4. The inversion device according to claim 2 or 3, The flexible tubular elongated member has a proximal end and a distal end, and a length is defined between the proximal end and the distal end, and the length is selected to be shorter than the length of the flexible 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, which is an inversion device.

5. The inversion device according to any one of claims 2 to 4, wherein the flexible tubular elongated member has two or more lumens extending through it, so as to allow an additional device to extend through the flexible tubular elongated member.

6. An inversion device according to any one of claims 2 to 5, The aforementioned flexible tubular elongated member has a proximal end and a distal end, The inversion device further comprises a proximal mount provided along the proximal end of the flexible tubular elongated member, The proximal end of the operating component is an inversion device operably associated with the proximal mount.

7. The inversion device according to any one of claims 1 to 6, further comprising a proximal mount, wherein the proximal end of the operating component is operably associated with the proximal mount.

8. The reversing device according to claim 7, further comprising a pull handle at the proximal end of the operating component.

9. The reversing device according to claim 8, wherein the proximal mount includes a pull handle mount.

10. The reversing device according to any one of claims 7 to 9, further comprising a locking system attached to the proximal mount and configured to temporarily hold the operating component under tension in order to reverse the flexible elongated member.

11. It is an inverted system, A medical device comprising a flexible elongated member having a proximal end, a distal end, and an outer surface extending between the proximal end and the distal end, A flexible tubular elongated member having a proximal end and a distal end and defining a lumen through which it passes, wherein the flexible tubular elongated member is configured to be attached to the outer surface of the flexible tubular elongated member, An actuation component extending through the lumen of the flexible tubular elongated member, the actuation component having a distal end operably associated with the distal end of the flexible elongated member, and a proximal end accessible for pulling the actuation component proximal to reverse the distal end of the flexible elongated member, An inversion system equipped with this system.

12. The inversion system according to claim 11, A distal mount coupled to the distal end of the flexible elongated member, wherein the distal end of the actuation component is operably associated with the distal end of the flexible elongated member via the distal mount, A pivot mount attached to the flexible elongated member proximal to the distal mount, wherein the operating region of the operating component pivots around the pivot mount, causing the distal end of the flexible elongated member to invert; An inversion system equipped with this system.

13. The inversion system according to claim 12, The length of the flexible tubular elongated member is less than the length of the flexible elongated member, The flexible tubular elongated member is 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 defines the pivot mount, forming an inversion system.

14. The reversing system according to any one of claims 11 to 13, further comprising a proximal mount provided along the proximal end of the flexible elongated member and operably associated with the proximal end of the flexible elongated member, wherein the proximal end of the actuation component is operably associated with the proximal mount.

15. The reversing system according to claim 14, further comprising a pull handle at the proximal end of the actuation component, wherein the proximal mount comprises a mount for the pull handle and a locking system configured to temporarily hold the actuation component under tension to reverse the flexible elongated member.

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