Devices, systems, and methods for attaching one medical device to another medical device.

Abstract

An auxiliary system for use with a medical device is provided, the auxiliary system having a sheath configured to be mounted along the medical device. A system is provided for rotatably aligning the distal end of the medical device with respect to the distal mount of the auxiliary system. Incidentally or alternatively, a system is provided for easily securing the auxiliary system and other medical devices to each other. For example, a system is provided for securing the sheath along the length of the medical device and then releasing the fixed connection.

Description

Technical Field

[0001] The present disclosure relates to devices, systems, and methods for attaching a medical device to another medical device. The present disclosure further relates to additional or ancillary devices and / or systems, including devices and / or systems and related methods for facilitating the attachment of a medical device and / or system to another medical device. The devices, systems, and methods of the present disclosure may be particularly suitable for minimally invasive medical / surgical procedures.

Background Art

[0002] Various devices (e.g., instruments, tools, etc.) and systems for performing surgical procedures are configured to be used with other devices, such as medical scopes, more specifically, existing scopes such as endoscopes (e.g., commercially available endoscopes, or endoscopes not otherwise customized for the devices or systems used with them). Such devices and systems can increase the bulk of the entire endoscopic system, which can be a challenge during endoscopic procedures. In addition, some of such devices and systems must be used with medical scopes that have two instrument channels, and may be limited to use with larger endoscopes that have such features. However, for various reasons, smaller medical scopes are preferred. For example, smaller endoscopes with smaller external dimensions can be advanced more easily through natural orbits and more easily through the meandering passages within the body. Further devices and systems have been developed for use with small medical scopes that have a single instrument channel or no instrument channel at all. Such devices and systems feature an end cap adapted to receive the distal end of the scope, can be used with the same scope regardless of the number of instrument channels within the scope, including smaller endoscopes, are available in many surgical settings, and can be advanced more easily through natural orifices. However, improvements to the devices and styles for fixing such systems to a medical scope or another medical device would be welcome. Furthermore, after the device or system is fixed to the medical scope, it is generally important to properly orient the medical scope so that imaging is stable. In addition, different medical scopes have imaging lenses in different locations. Current systems do not provide a method for consistent alignment with any available scope in proper rotational orientation relative to the end cap without operating the scope during attachment to the system. It is with respect to these and other considerations that improvements may be useful. [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] Auxiliary medical systems for use with another medical device having a proximal and distal end are disclosed in accordance with various principles of this disclosure. The auxiliary system includes a flexible elongated member having a device-engaging section sized, molded, configured, and / or dimensioned to engage with the other medical device; a distal mount configured to engage with the other medical device in proximity to the distal end of the other medical device; and a proximal mount configured to engage with the other medical device in proximity to the proximal end of the other medical device.

[0005] In some embodiments, the flexible elongated member is or includes a sheath having a selected length such that it extends at least partially along the length of the other medical device. In some embodiments, the sheath has a device engagement section having a concave shape configured to receive the convexly curved outer surface of the other medical device.

[0006] In some embodiments, the distal mount is configured to be attached to the distal end of a medical scope. In some embodiments, the distal mount includes a distal stop against which the distal end of the medical scope abuts when fitted into the distal mount, and the distal stop includes an indicia to which a feature portion of the medical scope can be rotatably aligned.

[0007] In some embodiments, the flexible elongated member has one or more auxiliary working channels extending through it. In some embodiments, the auxiliary medical system further includes one or more mounting strips having a first end that is attachable to a flexible elongated member and can be wrapped around the flexible elongated member and other medical devices for securing the auxiliary medical system to other medical devices. In some embodiments, the auxiliary medical system further includes a tape system comprising one or more mounting strips. In some embodiments, the tape system further comprises a tape applicator. In some embodiments, the distal mount includes a hook, and at least one of the one or more mounting strips includes a hole for securing on (over) the hook.

[0008] In some embodiments, the proximal mount is configured to be coupled to the handle of another medical device. In accordance with various principles of this disclosure, an auxiliary medical system for use with another medical device having a proximal and distal end is disclosed. The auxiliary system includes an auxiliary device configured to be attached to the other medical device, and at least one mount configured to engage the other medical device and the ends of a mounting strip configured to wrap around the auxiliary device and the other medical device.

[0009] In some embodiments, at least one mount is an end cap configured to be attached to the distal end of another medical device. In some embodiments, at least one mount includes at least one hook configured to engage with a hole at the end of a mounting strip configured to wrap around an auxiliary device and other medical devices. In some embodiments, the auxiliary medical system further includes at least one mounting strip having a first end, the at least one mounting strip having a hole defined through the strip and being molded to extend over at least one hook of the at least one mount for securing the first end of the at least one mounting strip to the at least one mount.

[0010] A method for engaging an auxiliary device with another medical device is disclosed in accordance with various principles of this disclosure. The method includes engaging a section of the auxiliary device with the other medical device, and securing the auxiliary device with the other medical device using two or more mounting strips, by attaching the free ends of the mounting strips to the auxiliary device and securing the mounting strips by wrapping them around the auxiliary device and the other medical device.

[0011] In some embodiments, the auxiliary device is a sheath, and engaging a section of the sheath with another medical device includes engaging a concave section of the sheath with a convex surface of the other medical device.

[0012] In some embodiments, the other medical device is a medical scope, and the auxiliary device further includes a distal mount configured to be attached to the distal end of the medical scope, and the method further includes oriented a feature portion on the distal mount of the auxiliary device relative to the feature portion of the medical scope.

[0013] In some embodiments, securing the auxiliary device to another medical device further includes securing the free end of at least one mounting strip to the auxiliary device, and then tightening at least one mounting strip while wrapping it around. In some embodiments, the auxiliary device further includes a distal mount configured to be attached to the distal end of the other device, and the method further includes hooking a hole formed in at least one free end of the mounting strip onto a hook extending from the distal mount.

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

[0015] [Figure 1] These are elevation views of devices and systems formed according to various principles of this disclosure. [Figure 2] This is a cross-sectional view along line II-II in Figure 1. [Figure 3] This is a distal end perspective view of a cap assembly formed according to various principles of this disclosure, which is attached to and appropriately oriented for another medical device. [Figure 4] This diagram is similar to Figure 3 and shows the cap assembly and other medical devices positioned relative to each other. [Figure 5] This is a schematic diagram of a taping system for securing a device and / or system formed according to various principles of the present disclosure to another device. [Figure 6] Figure 5 is a schematic diagram of a tape applicator that can be used with the taping system shown. [Figure 7]Perspective view of an endoscopic suture system according to an embodiment of the present invention. [Figure 8] Proximal perspective view of the suture device of the endoscopic suture system of FIG. 7. [Figure 9] Side view of the suture device of indeterminate length of the endoscopic suture system of FIG. 7. [Figure 10] Distal perspective view of a cap assembly attached to the distal end of an endoscope of an endoscopic suture system. [Figure 11] Distal perspective view of a cap assembly of a suture device with respect to an endoscope for an endoscopic suture system. [Figure 12] Cross-sectional view taken along line XII-XII of FIG. 7. [Figure 13] Distal schematic view of a cap assembly of a suture device with respect to an endoscope for an endoscopic suture system. [Figure 14] A view similar to FIG. 13, showing the endoscope rotated and aligned. [Figure 15] A view similar to the view of FIG. 11, with an endoscope properly oriented and advanced with respect to the distal end of the cap assembly. [Figure 16] Schematic view of a tape applicator. [Figure 17] Schematic view of a taping system for fixing the sheath of a suture device to an endoscope. [Figure 18] Showing the characteristics of the tape of the tape system [Figure 19] Showing the characteristics of the tape of the tape system [Figure 20] Schematic view of an inversion system for an endoscopic system as applied to the proximal handle of the system. [Figure 21] Schematic view of an inversion system for an endoscopic system as applied to the proximal handle of the system. [Figure 22] Schematic view of the details of one embodiment of a lock for an inversion system. [Figure 23]This is a schematic diagram of an endoscopic system undergoing distal inversion, which is applied by an inversion system. [Figure 24] Figure 22 is a schematic diagram showing the details of the lock's operation. [Figure 25] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 26] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 27] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 28] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 29] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 30] This demonstrates the use of tape along the sheath to secure it to the endoscope. [Figure 31] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 32] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 33] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 34] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 35] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 36] This shows the disassembly of the tape around the cap assembly. [Figure 37] This shows the tape separating from the cap assembly. [Figure 38] This shows the disintegration of the sheath from the endoscope. [Figure 39] Figures 13 and 14 show examples of alignment of the cap assembly. [Figure 40] Figures 13 and 14 show examples of alignment of the cap assembly. [Modes for carrying out the invention]

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

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

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

[0019] As used herein, “proximal” means the direction or location closest to the user (such as a healthcare professional or clinician or technician or operator or physician, such terms are used interchangeably herein and are not intended to be limiting, and include automated control systems, etc.) when the device is in use (e.g., when the device is introduced, implanted, positioned, or delivered to a patient) and / or closest to the delivery device; “distal” means the direction or location furthest from the user when the device is in use (e.g., when the device is introduced, implanted, positioned, or delivered to a patient) and / or closest to the delivery device; “longitudinal” means extending along the longer or larger dimension of an element; “longitudinal axis” means extending along the longitudinal range of an element, but not necessarily in a straight line, and not necessarily maintaining a fixed configuration when the element bends or curves; “axial” generally means being along the longitudinal axis. However, it will be understood that references to axial or longitudinal movement relating to the systems or 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 perimeter 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 hole. 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. Terms such as at the end, on the end, adjacent to the end, or along the end may be used interchangeably herein without limitation unless otherwise stated, and it will be understood that they are intended to indicate general relative spatial relationships rather than precisely defined locations.As understood herein, “corresponding” is intended to convey relationships between components, parts, elements, etc., that are configured to interact with one another or to have different intended relationships with one another. Finally, references to “at” a place or part are intended to include in and / or around such a place or part (e.g., along it, adjacent to it, nearby, etc.).

[0020] It is understood that the various principles of this disclosure may be applied to various medical procedures (in particular, surgical procedures). Such surgical procedures may be performed manually (e.g., with various instruments controlled by or by the hands of the medical professional(s) performing the procedure) and / or robotically (e.g., with automated devices such as robotic devices that control the various instruments used to perform the procedure, the automated devices being controlled by the medical professional). Furthermore, while various embodiments may be described herein relating to endoscopic procedures, it is understood that the principles of this disclosure do not need to be limited in this way.

[0021] In accordance with various principles of this disclosure, devices and / or systems are attached to medical devices. More specifically, devices and / or systems are attached to medical devices such as medical scopes, including, but not limited to, endoscopes. In some embodiments, devices and / or systems are configured to modify, enhance, improve, etc., the medical device to which the devices and / or systems are attached. It will be understood that terms such as modify, enhance, improve, etc., and their other grammatical forms may be used interchangeably herein without intent to limit. In accordance with various principles of this disclosure, devices and / or systems modify existing devices such as medical scopes. As used herein, “existing” is intended to encompass, for the devices and / or systems described herein, commercially available, existing, off-the-shelf, or otherwise available and not customized, modified, etc. Accordingly, the devices and / or systems of this disclosure are not designed for any particular design, configuration, brand, etc., and may be considered universally applicable to the type or category of medical device to which the devices and / or systems are attached (e.g., medical scopes). In some embodiments, the devices and / or systems of the Disclosure enhance the functionality of another medical device or system. For example, according to various principles of the Disclosure, the devices and / or systems of the Disclosure provide additional working channels for a medical scope, for example, by providing an external working channel on the scope. The principles of the Disclosure may be particularly useful in conjunction with medical devices and / or systems for performing minimally invasive surgical procedures, such as transcatheter, transcatheter, and endoscopic procedures, which do not require surgical incision (cutting the patient) but instead access a target site inside the patient's body through a natural opening (or, in some cases, a small incision that is not considered to constitute an incision by surgical incision).

[0022] Devices and / or systems that facilitate the attachment of a device and / or system to another medical device are disclosed herein in accordance with various further principles of this disclosure. In some embodiments, devices and / or systems disclosed herein as facilitating the attachment of other devices and / or systems are also configured to facilitate the removal or detachment of such other devices and / or systems.

[0023] Various embodiments of devices and / or systems and related methods that are attached to medical devices, or devices and / or systems and related methods that facilitate the attachment of devices and / or systems to medical devices, are described herein with reference to examples shown in the accompanying drawings. References herein to “one embodiment,” “embodiment,” “several embodiments,” and “other embodiments” 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. In other words, any of the features, structures, concepts, and / or characteristics described herein can be mixed and adapted to create hybrid embodiments, and such hybrid embodiments are within the scope of this disclosure. Furthermore, references to “one embodiment,” “embodiment,” “several embodiments,” and “other embodiments” in various parts of this specification do not necessarily all refer to the same embodiment, and separate or alternative embodiments do not necessarily exclude other embodiments from each other. Moreover, it should be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and distinct from one another and may be used or exist individually or in various combinations with each other to create alternative embodiments that are considered part of this disclosure.Therefore, this disclosure is not limited to the embodiments specifically described herein, and it would be extremely cumbersome to describe all of the numerous possible combinations and partial combinations of features, structures, concepts, and / or properties, and the examples of embodiments disclosed herein are not intended to limit broader aspects of this disclosure. The various dimensions provided herein are examples, and it should be understood that those skilled in the art can easily determine an appropriate range of standard deviation and acceptable variation therefrom, which are covered by this disclosure and any claims associated therewith. The following description is merely an illustrative example of embodiments and is not intended to limit broader aspects of this disclosure.

[0024] Referring here to the drawings, Figure 1 shows an example of an embodiment of a system 1000 for attaching an auxiliary device 1100 to a medical device 1200 that conforms to various principles of the present disclosure. The illustrated example of an embodiment of the auxiliary device 1100 includes a system 1000 and a sheath 1110 adapted to house the medical device 1200 to which the auxiliary device 1100 is attached. In one illustrated embodiment, the medical device 1200 is an endoscope. However, the principles of the present disclosure are applicable to other medical devices, and the present disclosure is not limited to use with endoscopes. In some embodiments, the auxiliary device 1100 is configured to be attached to the medical device 1200, for example, by having its device engagement section. The device engagement section of the auxiliary device 1100 may be any section of the auxiliary device 1100 that is sized, molded, configured, and / or dimensioned to engage with, accept, attach to, or otherwise bond to the medical device 1200, such as to the outer surface (e.g., side) of the medical device 1200. It should be understood that terms such as engage, accept, attach, combine, connect, adhere, associate, and operationally associate with, including other grammatical forms, may be used interchangeably herein without limitation unless otherwise indicated. System 1000 may include additional structures, features, devices, etc., to facilitate the retention of the auxiliary device 1100 relative to the medical device 1200 (for example, holding the auxiliary device 1100 relative to the medical device 1200), as will be described in more detail below.

[0025] As described above, in the example of the embodiment of the auxiliary device 1100 shown in Figure 1, the auxiliary device 1100 includes a sheath 1110. In some embodiments, the device-receiving mounting section of the auxiliary device 1100 is defined and extends along a portion of the sheath 1110. For example, as shown in the cross-sectional view of Figure 2 along line II-II in Figure 1, at least a portion of the sheath 1110 includes a concave recess 1112 that is sized, molded, configured, and / or dimensioned to facilitate the attachment of the sheath 1110 to the medical device 1200. For example, the concave recess 1112 defined along the device-receiving mounting section of the sheath 1110 may be sized, molded, configured, and / or dimensioned so that the sheath 1110 can extend close to the outside of the medical device 1200. For example, the curvature of the recessed area 1112 may be selected to fit against and / or receive the exterior of any of various commercially available endoscopes. In some embodiments, the recessed area 1112 may extend more than 180° around the circumference of the medical device 1200, thereby partially enclosing the exterior of the medical device 1200. In some embodiments, the recessed area 1112 may extend along a portion of the length of the sheath 1110, or substantially along the entire length of the sheath 1110, facilitating the navigation of the medical device 1200 having a system 1000 attached thereto.

[0026] In accordance with various principles of this disclosure, the auxiliary device 1100 may be further configured to facilitate the addition of one or more additional devices, tools, instruments, components, etc., along the system 1000. In some embodiments, the auxiliary device 1100 defines one or more auxiliary work channels to complement one or more work channels of the medical device 1200. In a cross-sectional view of an example embodiment of the auxiliary device 1100 shown in Figure 2, the sheath 1110 of the auxiliary device 1100 defines one or more auxiliary work channels 1113, 1115, etc., by having one or more lumens defined longitudinally through it, and defining work channels into which instruments, tools, devices, components, etc. (such terms are used interchangeably herein without intent to limit) can be inserted, advanced, retracted, etc. The one or more auxiliary work channels 1113, 1115 provide additional work channels throughout the system to complement one or more work channels of the medical device 1200. In some embodiments, elongated tubular members 1114, 1116 (e.g., catheters, tubes, sheaths, etc.) may be provided within one or both of the auxiliary working channels 1113, 1115, respectively, defining working channels through which further devices are inserted, advanced, retracted, etc. The elongated tubular members 1114, 1116 may be separately formed elements or may be formed by separate lumens of a common elongated tubular member, and the disclosure is not limited thereto. In embodiments in which the elongated tubular members 1114, 1116 are provided within the auxiliary working channels 1113, 1115, when the sheath 1110 is attached to the medical device 1200, the elongated tubular members 1114, 1116 are similarly attached to the medical device 1200 and extend longitudinally along the medical device 1200 to facilitate the advance or retraction of devices passing through them. In some embodiments, the sheath 1110 extends along substantially the entire length of the elongated tubular members 1114, 1116 (e.g., at least 80 percent, or at least 90 percent), and one or both ends of the elongated tubular members 1114, 1116 (e.g., terminal, free end) extend beyond the respective distal or proximal ends 1110d, 1110p of the sheath 1110.However, the disclosure is not limited in this way, and the sheath 1110 may extend along the entire length or partial length of the elongated tubular members 1114, 1116, or it may be provided as a section along a selected portion of the elongated tubular members 1114, 1116.

[0027] In some embodiments, a portion of one or both of the elongated tubular members 1114, 1116 is fixed to auxiliary working channels 1113, 1115 on which the elongated tubular members 1114, 1116 extend. For example, one or both of the elongated tubular members 1114, 1116 may be affixed along one or more points along the auxiliary working channels 1113, 1115 defined through the sheath 1110. In some embodiments, the system 1000 includes a distal mount 1300 at its distal end 1000d, configured to be attached to a medical device 1200 (for example, to the distal end 1200d of the medical device 1200), and the distal ends of one or both of the elongated tubular members 1114, 1116 are fixed to such distal mount 1300. In some embodiments, at least one distal end of the elongated tubular members 1114, 1116 extends through a through bore defined through the distal mount 1300 and is attached thereto. In an example of the embodiment shown in Figure 1, the elongated tubular members 1114, 1116 extend along the medical device 1200 beyond the distal end 1110d of the sheath 1100, and then extend into the respective through bores of the distal mount 1300. In some embodiments, the system 1000 includes a proximal mount 1400 at its proximal end 1000p, configured to be attached to the medical device 1200 (for example, to the proximal end 1200p of the medical device 1200). In some embodiments, one or both proximal ends of the elongated tubular members 1114, 1116 are fixed to (for example, mounted on) the adapter 1120 at the proximal end 1100p of the auxiliary device 1100. In some embodiments, the adapter 1120 may include access ports 1403, 1405 through which the lumens passing through the respective elongated tubular members 1114, 1116 can be accessed.

[0028] In accordance with various principles of this disclosure, the distal mount 1300 described above is a structure or device sized, molded, configured, and / or dimensioned to be attached to a medical device 1200. In some embodiments, the distal mount 1300 is configured to be attached to the distal portion of the medical device 1200. In some embodiments, the distal mount 1300 is an end cap or other structure with features, components, devices, etc., that provide further functionality, including structures and / or devices for performing procedures on the body, such as body tissue. In some embodiments, the distal mount 1300 has at least one section configured to engage with, accept, or attach to a portion of the medical device 1200. In some embodiments, such a section allows for a removable engagement between the distal mount 1300 and the portion of the medical device 1200. In some embodiments, the distal mount 1300 is molded to extend in a sufficient amount around the circumference / outer edge of the medical device 1200 so that, once engaged with the medical device 1200, it remains attached thereon. For example, the distal mount 1300 may include a peripheral engagement structure that is sized, molded, configured, and / or dimensioned to be positioned around the medical device 1200 at approximately 180°, preferably slightly larger than 180°. In some embodiments, the engagement structure includes a recessed area 1312 that is sized, molded, configured, and / or dimensioned to facilitate the attachment of the distal mount 1300 to the medical device 1200, such as to the distal end 1200d of the medical device 1200. In some embodiments, the distal mount 1300 may be considered a clip that engages with the medical device 1200 by friction fit or interlock fit. In some embodiments, the distal mount 1300 is formed from an elastic material that allows the distal mount 1300 to be released from the medical device 1200, for example, at the completion of a procedure (to allow sterilization and reuse of the medical device 1200).In some embodiments, the system 1000 includes, as will be described in more detail below, a separate element for further securing the distal mount 1300 to the medical device 1200 and, optionally, for facilitating the removal of the distal mount 1300 after use of the system 1000.

[0029] In accordance with various principles of this disclosure, it may be desirable to orient the system 1000, such as the sheath 1110 and / or its distal mount 1300, toward one or more feature parts or structures of the medical device 1200. For example, if the system 1000 is configured to guide an instrument to the distal end 1200d of the medical device 1200, it may be desirable that such an instrument be positioned at a specific location relative to the working channel of the medical device 1200. Incidentally or alternatively, if the medical device 1200 is a medical scope with an optical system (e.g., a visualization system such as a camera or optical fiber), it may be desirable that any devices, structures, etc., delivered by or otherwise associated with the system 1000 be positioned so as not to interfere with the function of the optical system of the medical device 1200.

[0030] In accordance with various principles of this disclosure, the distal mount 1300 of the System 1000 of this disclosure may include one or more alignment features that are structured, formed, molded, positioned, or otherwise positioned to facilitate the alignment of the distal mount 1300 with respect to a medical device 1200. In some embodiments, the alignment features include a structure to which a user can be guided when rotating and oriented the System 1000 with respect to the medical device 1200. In some embodiments, the structure is formed along the outer circumference / circumference of the distal mount 1300. In some embodiments, the structure is provided along the distal end 1300d of the distal mount 1300. In an example embodiment of the distal mount 1300 of an example embodiment of the System 1000 shown in Figure 3, the alignment features include an indicia 1302 and / or recess 1304 along the outer circumference of the distal mount 1300, and optionally along the distal end 1300d of the distal mount 1300.

[0031] In some embodiments, an indicator portion 1302 on the distal mount 1300, formed according to various principles of this disclosure, can provide visual assistance when rotatably aligning the distal mount 1300 with respect to the medical device 1200. In some embodiments, the indicator portion 1302 is a contrasting color to the color of the portion of the distal mount 1300 on which the indicator portion 1302 is provided.

[0032] In some embodiments, recesses 1304 on a distal mount 1300 formed according to various principles of the present disclosure are sized, molded, configured, and / or dimensional to be positioned relative to a feature of the medical device 1200, not only to facilitate the orientation of the distal mount 1300 relative to the medical device 1200, but also to allow clearance for the function of one or more feature of the medical device 1200. For example, a recess 1304 may be positioned, sized, molded, configured, and / or dimensional to allow passage access to or from a working channel 1203 of any of the various medical devices 1200 in the form of a commercially available endoscope from any of various manufacturers, when the distal mount 1300 is properly rotatably aligned with the medical device 1200. In some embodiments, the recess 1304 may be considered a clearance window. In some embodiments, additional (optionally, smaller) recesses 1306a, 1306b (which may be considered additional clearance windows) may be provided along the outer circumference / circumferential of the distal mount 1300 and, optionally, along the distal end 1300d of the distal mount 1300. An illustrated example of an embodiment of the additional recesses 1306a, 1306b is located on either side of the recess 1304, for example, to provide clearance for other feature parts or structures of the medical device 1200. For example, the additional recesses 1306a, 1306b may be positioned, sized, molded, configured, and / or dimensioned to prevent interference with the visualization system (e.g., optical lenses) of the medical device 1200 in the form of a medical scope, and / or other working feature parts of various medical devices such as a medical scope (e.g., endoscope).

[0033] In some embodiments, the index portion 1302 can be used to facilitate the alignment of one or more recesses 1304, 1306a, 1306b with respect to the medical device 1200. For example, the index portion 1302 may be aligned with a feature of the medical device 1200, such as a working channel 1203 of the medical device 1200 in the form of a medical scope or a visualization system (e.g., a camera, optical lens, etc.). Such rotational alignment of the system 1000 of this disclosure with respect to the medical device 1200 ensures that various feature or systems of the medical device 1200 can be used without obstruction. For example, alignment between an index section 1302 provided on the distal mount 1300 of the system 1000, formed according to various principles of this disclosure, and a medical device 1200 in the form of a medical scope, ensures an unobstructed field of view and proper orientation of a visualization system (e.g., camera, optical lens, etc.) to further tools, devices, instruments, etc., advanced and utilized at the distal end 1200d of the medical device 1200 and / or distal to it, regardless of the specific details, structure, configuration, etc., of the medical device 1200 selected for use with the system 1000 of this disclosure (e.g., from a variety of medical devices from various manufacturers). In some embodiments, the relative orientation, access, field of view, etc., of the medical device 1200 can be assured / confirmed without requiring the medical device 1200 to be powered on, such as by powering on the medical scope and previewing the field of view of the scope (e.g., the field of view from the lens on a display associated with the scope) before performing a procedure using the scope and system 1000 of this disclosure. This significantly reduces preparation time before a procedure.

[0034] In some embodiments, to further facilitate the placement of the system 1000, formed according to various principles of this disclosure, on the medical device 1200, the distal mount 1300 includes a stopper 1308. The stopper 1308 may be positioned, sized, molded, configured, and / or dimensional to facilitate the longitudinal orientation of the system 1000 on the medical device 1200. For example, the stopper 1308 may be positioned, sized, molded, configured, and / or dimensional to facilitate the longitudinal orientation of the distal mount 1300 on the distal end 1200d of the medical device 1200. In the examples of embodiments shown in Figures 3 and 4, the stopper 1308 is formed on or along the distal end 1300d of the distal mount 1300. In some embodiments, the stopper 1308 is positioned, sized, molded, configured, and / or dimensioned to prevent or block the distal end 1200d of the medical device 1200 from extending beyond the longitudinal position of the stopper 1308. In an embodiment of the features illustrated in Figure 4, the stopper 1308 extends radially inward into a recessed area 1312 formed within the distal mount 1300 to prevent or block the distal end 1200d of the medical device 1200 from extending beyond the longitudinal position of the stopper 1308. As can be understood by referring to Figure 4, the distal end 1200d of the medical device 1200 may be advanced longitudinally toward the stopper 1308 until it extends into the recessed area 1312 of the distal mount 1300 and is seated against the stopper 1308. Such relative longitudinal positioning of the distal mount 1300 with respect to the medical device 1200 can also facilitate the use of various devices, instruments, and components of the system 1000 of this disclosure, and / or advancement to the treatment site by the use of the medical device 1200 with which the system 1000 is associated. It will be understood that rotational and longitudinal alignment may be performed in any order (rotational alignment may be performed before or after longitudinal alignment), or together (rotational and longitudinal alignment may be performed in relation to each other and in harmony).

[0035] The proximal mount 1400 described above, configured to facilitate association between a system 1000 formed in accordance with the various principles of this disclosure and a medical device 1200, is a structure or device sized, molded, configured, and / or dimensioned to be mounted to the medical device 1200. In some embodiments, the proximal mount 1400 is configured to be mounted to a proximal portion of the medical device 1200. The proximal mount 1400 may constitute a section, or otherwise may include such a section, that is sized, molded, configured, and / or dimensioned to mount the system 1000 to a handle of the medical device 1200. In some embodiments, the proximal mount 1400 has at least a section that is configured to engage with, accept, and mount to a portion of the medical device 1200, and, once engaged, remain mounted to it. In some embodiments, such sections allow for a removable engagement between the proximal mount 1400 and a portion of the medical device 1200, for example, to be removed upon completion of a procedure (e.g., to allow for sterilization and reuse of the medical device 1200). In some embodiments, the proximal mount 1400 may be a bracket with one section connected to an auxiliary device 1100 and the other section connected to the medical device 1200. However, the disclosure is not limited in this respect.

[0036] As can be understood, a system 1000 formed according to various principles of this disclosure can improve the functionality of a system utilizing a medical device 1200 without impairing the functionality of the medical device 1200. Specifically, the auxiliary work channels 1113, 1115, and any one or more elongated tubular members 1114, 1116 enhance or complement the work channels of an existing medical device 1200 to which the system 1000 is attached. For example, since additional work channels are provided by the system 1000, the medical device 1200 to which the system 1000 is associated is not limited by the size (e.g., inner diameter) and / or number of work channels of the medical device 1200. Each of the auxiliary work channels 1113, 1115 provided by a system 1000 formed according to various principles of this disclosure can facilitate the advancement and use of devices, tools, instruments, etc., alongside the medical device 1200 to which the system 1000 is associated, allowing the work channels of such medical device 1200 to be used for other purposes or functions. In some embodiments, the sheath 1110 formed according to various principles of the present disclosure may have further structures to facilitate the advance and / or retraction of further components, devices, tools, instruments, etc., to the medical device 1200. For example, in an example of the embodiment shown in Figure 2, the sheath 1110 may include one or more further lumens or auxiliary working channels 1117 that are sized, molded, constructed, and / or dimensioned to allow the passage of further components, tools, devices, instruments, etc. Depending on the overall cross-sectional shape, material, and other properties of the sheath 1110, the further auxiliary working channels 1117 may allow the passage of two or more further components, tools, devices, instruments, etc., or may include separate further auxiliary working channels for each component, tool, device, instrument, etc. For example, in an example of the embodiment shown in Figure 2, the illustrated further auxiliary working channel 1117 allows the passage of both a first elongated element 1118a and a second elongated element 1118b. The elongated elements 1118a and 1118b may be formed from materials that are transmissible longitudinally through the auxiliary working channel 1117 and do not interfere with each other.Optionally, separate lumens can be provided for the long elements 1118a and 1118b.

[0037] As described above, a system 1000 formed according to various principles of this disclosure may include further structures, features, devices, etc., to facilitate the retention of an auxiliary device 1100 relative to a medical device 1200 (e.g., holding the auxiliary device 1100 relative to the medical device 1200). In an example of an embodiment of system 1000 shown in Figure 5, a system 1000 formed according to various principles of this disclosure includes a plurality of attachment strips 1500 that are sized, molded, configured, and / or dimensioned to facilitate the retention of one or more components of system 1000 relative to the medical device 1200. For example, in an example of an embodiment of system 1000 shown in Figure 5, the attachment strips 1500 are provided along the length of system 1000 to secure at least a portion of the sheath 1100 relative to the medical device 1200 and / or to facilitate its retention. The sheath 1100 may be provided with a plurality of attachment strips 1500 pre-positioned along the length of the sheath 1100. In an example of the embodiment shown in Figure 5, three mounting strips 1500d, 1500p, and 1500i are provided: a distal mounting strip 1500d located adjacent to the distal end 1100d of the sheath 1110; a proximal mounting strip 1500p located approximately midway or proximal to an intermediate position along the proximal end 1100d of the sheath 1100 or along the length of the sheath 1100; and one or more intermediate mounting strips 1500i located between the distal mounting strip 1500a and the proximal mounting strip 1500p. In some embodiments, as shown, the intermediate mounting strip 1500i is located closer to the distal mounting strip 1500d than to the proximal mounting strip 1500p. However, other positions are also within the scope of this disclosure. The positioning of two or three mounting strips 1500 spaced apart from each other according to various principles of the present invention has been shown to result in good stability of the sheath 1100 relative to the medical device 1200 associated with the system 1000, particularly when the system 1000 and / or medical device 1200 are in use.In other words, an additional mounting strip 1500 can be provided along the length of the sheath 1100 and used in the manner described above.

[0038] In accordance with various principles of this disclosure, the mounting strip 1500 may be in the form of any of various strips or other elongated elements that can fix and / or maintain a portion of the system 1000 (e.g., its sheath 1110) to the medical device 1200. For example, the mounting strip 1500 may be formed of a strip of material (e.g., a flat band), tape, cord, or other preferably elongated element. In some embodiments, the mounting strip 1500 has a length selected to allow the mounting strip 1500 to wrap around the outer circumference (e.g., circumference) of the system 1000 and a portion of the medical device 1200 at least once. In some embodiments, the mounting strip 1500 may wrap around the outer circumference of the system 1000 and a portion of the medical device 1200 slightly more than one turn (greater than 360°). In some embodiments, the mounting strip 1500 is formed from a tape having an adhesive portion pre-applied to the sheath 1100, an intermediate portion that is non-adhesive to prevent adhesion to the medical device 1200 when the mounting strip 1500 is wrapped around the medical device 1200, and an end portion that extends from the intermediate portion to the free end of the mounting strip 1500, carrying adhesive in at least a portion thereof, and is adapted to adhere to the portion of the tape wrapped around the system 1000 and the medical device 1200.

[0039] In some embodiments, one or more of the mounting strips include a pull-off protective strip that covers one or more portions of the mounting strip 1500, for example, to cover the adhesive thereon. The pull-off protective strip may include a free end (e.g., an L-shaped tab) configured to facilitate removal of the pull-off protective strip from the portion of the mounting strip 1500. In some embodiments, the tab includes a highly visible color that contrasts with the sheath 1100 and / or an indicator portion that indicates the direction in which the protective strip should be pulled to peel it from the mounting strip 1500 and expose the adhesive.

[0040] Incidentally or alternatively, one or more of the mounting strips 1500 are configured to facilitate removal from the system 1000 after use. In some embodiments, one or more of the mounting strips 1500 may be cut with readily available blades / scissors and / or have at least one perforation line or other type of line-of-weakness to facilitate breakaway disassembly of the system 1000 from the medical device 1200.

[0041] In some embodiments, as in the example of the embodiment shown in Figure 5, a mounting strip 1500m is provided to fix and / or maintain the distal mount 1300 of the system 1000 to the medical device 1200. The mounting strip 1500m may have the same or different configuration as the mounting strip 1500 provided along the sheath 1110, and the disclosure is not limited in this respect.

[0042] In an example of an embodiment of the distal mount 1300 shown in Figure 3, the distal mount 1300 includes one or more structures 1310 that facilitate the fastening and / or connection of one or more mounting strips 1500m to the distal mount 1300. For example, in an example of an embodiment shown in Figure 3, the distal mount 1300 includes one or more longitudinally spaced hooks 1310. In some embodiments, the hooks 1310 are identified by a color contrasting with the surrounding area of ​​the distal mount 1300 and / or numbered with indexes, for example, "1" and "2" (for example, according to the intended order of use). In some embodiments, the mounting strips 1500m have openings that penetrate part of them (for example, the proximal portion), and these openings are fastened to the distal mount 1300, for example, by extending over the hooks 1310 on the distal mount 1300. Once attached to the distal mount 1300, the mounting strip 1500m may be pulled and wrapped around the distal mount 1300 and the medical device 1200 to ensure a tight and secure connection between them.

[0043] In some embodiments, a system 1000 formed according to various principles of the present disclosure also includes a tape applicator 1600 configured to facilitate the application of a mounting strip 1500m to a distal mount 1300. An example of an embodiment of the tape applicator 1600 shown in Figure 6 includes a handle 1602, which has a proximal end 1602p configured to be grasped by a user and a distal end 1602d to which a spool 1610 carrying the mounting strip 1500m can be mounted. The distal end 1602d of the handle 1602 may include a narrowed extension to which a spool mount 1604 is formed. In some embodiments, the mounting strip 1500m has a terminal end 1502 which is a non-adhesive free end from which an opening or loop 1503 is formed. The opening or loop 1503 is sized, molded, constructed, and / or dimensioned to be attached to one of the hooks 1310 on the distal mount 1300 (as shown above with reference to Figure 3) to facilitate a secure connection between the mounting strip 1500m and the distal mount 1300. In some embodiments, the loop 1503 is reinforced to withstand the tensile forces applied to the mounting strip 1500m when wrapping the mounting strip 1500m around the distal mount 1300 and the medical device 1200 to ensure a secure connection between them. In some embodiments, the loop 1503 is provided in a color to facilitate its identification (e.g., locating the loop 1503 in an operating room environment).

[0044] 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.

[0045] Referring to Figures 7 to 10, 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 10). 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.

[0046] The suturing system 21 includes a suturing device 22 (Figure 8), a needle assembly 70 (Figure 10) that can move through tissue by the suturing device 22, and first and second devices 38, 40 (Figure 10) used in conjunction with the suturing device 22.

[0047] Referring to Figures 7 to 9, the suturing device 22 has a proximal operable handle 24 with an attachment 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.

[0048] Referring to Figures 8, 9, and 12, 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.

[0049] 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.

[0050] Referring to Figure 10, 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 mounted on a second pin 66 on the support bracket 54 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.

[0051] 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.

[0052] Referring to Figures 10 and 11, 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.

[0053] Referring to Figures 9 and 12, the distal end of the first catheter 34 is fixed in a first through bore 86, and its proximal end is connected to a first connector 33 on the handle bracket 26. The distal end of the second catheter 36 is fixed in a second through bore 88, and its proximal end is connected to a second connector 35 on the handle bracket 26. The first and second catheters 34, 36 may be separate catheters or separate lumens of a common catheter. In a preferred embodiment, the catheters 34, 36 are separate catheters covered along substantially all of their total length (e.g., at least 80 percent, more preferably at least 90 percent) by a preferably crescent-shaped common sheath 89. Alternatively, the common sheath 89 may extend along the total length of the catheters 34, 36, along the length of a portion thereof, or may be provided in segments along selected portions of the catheters 34, 36. In a preferred embodiment, the common sheath 89 is flexible and defines a lumen 90 for the catheter 34, a lumen 92 for the catheter 36, and a lumen 94 for both the transmission assembly 42 and the inverting pull string 100, the functions of which are described below. If necessary, separate lumen may be provided for the transmission assembly 42 and the pull string 100. A recessed area 96 is provided along the length of the sheath 89, and it is preferable that the sheath be able to extend close to the outside of the endoscope 12 of appropriate dimensions. In one embodiment, the sheath 89 is adapted to accommodate the endoscope by extending more than 180° around the circumference of the endoscope 12, which is preferably of appropriate dimensions, thereby partially surrounding the outside.

[0054] Referring to Figures 9 and 10, 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.

[0055] Referring to Figure 11, 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.

[0056] Referring to Figures 11, 13, 14, and 15, 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, which includes a maximum 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 aligning the designated endoscope feature with respect to the guide 112 in a rotational direction (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.

[0057] Referring to Figure 15, 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.

[0058] Referring to Figure 16, 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.

[0059] Referring here to Figures 17, 18, and 19, 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 18). 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 19).The perforations 152 are preferably provided at or near the joint between the second portion 142 and the third portion 144 of the tape.

[0060] Referring to Figures 9, 20, and 21, 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 9) 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 10). 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 22).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 23, 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 24). 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 20). 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.

[0061] 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 11). 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 13 and 14). The endoscope 12 is then pushed in completely, if necessary, until it contacts the distal stop 106 (Figure 15).

[0062] Next, referring to Figures 25, 26, and 27, 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 28 and 29, 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.

[0063] Next, referring to Figures 12, 18, 19, and 30, 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.

[0064] The collar 28 is appropriately positioned on the proximal handle 45 of the endoscope 12 (Figure 7). 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.

[0065] Referring to Figures 7 and 31, 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 30. Referring to Figure 32, 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 9), exits the second through bore 88 (Figure 10), 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 33. 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 34). 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 10). 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 35).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.

[0066] 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 by both Figures 36 and 37. Next, referring to Figure 38, 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 19), 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.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] According to various principles of this disclosure, an example of an embodiment of an endoscopic device for use with an endoscope includes a proximal handle assembly, a distal cap assembly, a sheath, 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.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] 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.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] 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 it 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.

[0104] The preceding discussions are presented for illustrative and explanatory purposes, with 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.

[0105] 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.

[0106] 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 auxiliary medical system for use with another medical device having a proximal and distal end, wherein the auxiliary system is: A flexible elongated member having a device engagement section sized, molded, configured, and / or dimensioned to engage with other medical devices, A distal mount configured to be adjacent to the distal end of the other medical device and to engage with the other medical device, A proximal mount configured to be adjacent to the proximal end of the other medical device and to engage with the other medical device, A medical support system equipped with these features.

2. The auxiliary medical system according to claim 1, wherein the flexible elongated member comprises a sheath having a length selected to extend at least partially along the length of the other medical device.

3. The auxiliary medical system according to claim 2, wherein the sheath has a device engagement section having a concave shape configured to receive the convexly curved outer surface of the other medical device.

4. The auxiliary medical system according to any one of claims 1 to 3, wherein the distal mount is configured to be attached to the distal end of a medical scope.

5. The auxiliary medical system according to claim 4, wherein the distal mount includes a distal stop portion against which the distal end of the medical scope abuts when fitted into the distal mount, and the distal stop portion includes an indicator portion to which the feature portion of the medical scope can be rotatably aligned.

6. The auxiliary medical system according to any one of claims 1 to 5, wherein the flexible elongated member has one or more auxiliary work channels extending through it.

7. The auxiliary medical system according to any one of claims 1 to 6, further comprising one or more mounting strips having a first end that can be attached to the flexible elongated member, and which can be wrapped around the flexible elongated member and the other medical device to secure the auxiliary medical system to the other medical device.

8. The auxiliary medical system according to claim 7, further comprising a tape system including one or more mounting strips.

9. The auxiliary medical system according to claim 8, further comprising a tape applicator.

10. The auxiliary medical system according to any one of claims 7 to 9, wherein the distal mount includes a hook, and at least one of the one or more mounting strips includes a hole for fixing onto the hook.

11. The auxiliary medical system according to any one of claims 1 to 10, wherein the proximal mount is configured to be connected to the handle of the other medical device.

12. An auxiliary medical system for use with another medical device having a proximal and distal end, wherein the auxiliary system is: An auxiliary device configured to be attached to other medical devices, At least one mount configured to engage with the other medical device and the end of a mounting strip configured to wrap around the auxiliary device and the other medical device, A medical support system equipped with these features.

13. The auxiliary medical system according to claim 12, wherein the at least one mount is an end cap configured to be attached to the distal end of the other medical device.

14. The assistive medical system according to claim 12 or 13, wherein the at least one mount includes at least one hook configured to engage with a hole at the end of a mounting strip configured to wrap around the assistive device and the other medical device.

15. The assistive medical system according to claim 14 further comprises at least one mounting strip having a first end with a hole, the hole being defined through the first end and shaped to extend over the at least one hook of the at least one mount for securing the first end of the at least one mounting strip to the at least one mount.

Images