Devices, systems, and methods for performing procedures on an organization

Abstract

A movable device for a system for performing medical procedures. The movable device has a reconfigurable portion that can hold the movable device in a selected position relative to other components of the system. The movable device may be movable relative to other components of the system, and the reconfigurable portion may be bent or otherwise reconfigured relative to the system to hold the movable device in a selected position. The movable device may be a tissue grasping device. The tissue grasping device may be formed to allow grasping and releasing of tissue without damaging the tissue. The tissue grasping device may include a tissue engagement element that may be formed from a spirally laser-cut tube.

Description

Technical Field

[0001] The present disclosure relates to devices, systems, and methods including a movable device for treating tissue. More specifically, the present disclosure relates to a movable device of a system having a reconfigurable portion that can be reconfigured and engaged with another component of the system, such as to maintain the position of the movable device, and related methods. The present disclosure also relates to devices, systems, and methods for grasping tissue. More specifically, the present disclosure relates to devices, systems, and methods for grasping and releasing tissue within the body. Optionally, the device for grasping tissue has a reconfigurable portion that can maintain a selected grasping position of the tissue.

Background Art

[0002] Various devices (e.g., instruments, tools, etc.) and systems for performing surgical procedures or treatments are configured to advance, retract, and be delivered through tubular elongated members. For example, to avoid more invasive incision surgery (surgery in which a larger portion of the patient's body is incised), various surgical procedures can be performed transcatheterally or endoscopically (using an endoscope) with a flexible tubular elongated member extended through a natural opening, cavity, or passage within the patient's body. Laparoscopic procedures can also utilize a flexible tubular elongated member that is inserted through a small incision, through which devices and systems can advance, retract, and be delivered. The flexible tubular elongated member may be a medical scope, such as an existing endoscope (e.g., a commercially available endoscope, or an endoscope that has not been separately customized for a device or system used with it). Through-the-scope ("TTS") endoscopic devices perform various diagnostic, therapeutic, and other functions by passing through a defined working channel through a medical scope (e.g., through the flexible insertion portion of the medical scope). Through-the-scope and other transluminal devices include tissue graspers, tissue cutting devices, snares, suturing devices, and biopsy devices. During transvascular and / or endoscopic procedures, the tubular elongated member (through which further devices are passed) is typically held and manipulated by the physician ("primary user"), while one or more devices extending through the tubular elongated member are typically manipulated by a second physician, assistant, or member of the procedure team ("secondary user"). During the procedure, the two users must communicate with each other to coordinate the positioning of the tubular elongated member and the devices extending through it. As a result, continuous communication and coordination of actions and activities are required, which may prolong the time required to complete the procedure. Lack of communication or misunderstanding between the two users may result in suboptimal use of the tubular elongated member and the devices used with it, which may require further procedure steps or lead to unsatisfactory procedure outcomes. It is with respect to these and other considerations that this improvement may be useful.In addition, various improvements to tissue grasping devices and systems, which can be used independently or in conjunction with improvements addressing the aforementioned issues, are described herein. [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] In accordance with various principles of this disclosure, a system for performing medical procedures within a patient's body includes a flexible elongated member that can be inserted into a target site within the patient's body, and a movable device that is movable relative to the flexible elongated member. In some embodiments, the movable device includes a reconfigurable portion that can be reconfigured by a user relative to at least a portion of the flexible elongated member.

[0005] In some embodiments, the reconfigurable portion can be configured relative to the flexible elongated member to maintain a selected position of a movable device relative to the flexible elongated member. In some embodiments, the reconfigurable portion is bendable or otherwise deformable relative to the flexible elongated member.

[0006] In some embodiments, the flexible elongated member is a medical scope. In some embodiments, the system further includes an auxiliary flexible tubular elongated member that is extendable along the medical scope and defines a lumen through which a movable device can move. In some embodiments, the movable device is movable through a working channel defined through the medical scope.

[0007] In some embodiments, the movable device includes an operable component on its distal end, configured to engage with tissue, the tissue engaged by the operable component exerting a distally directed force on the movable device. In some embodiments, a reconfigurable portion maintains the movable device against a flexible elongated member and against distally directed forces exerted on it by the tissue engaged by the movable device. In some embodiments, the operable component is a helical tissue-engaging element.

[0008] In some embodiments, the reconfigurable portion is adjacent to the user-engageable portion of the movable device. In some embodiments, the system further includes a further device that can operate together with the movable device. In some embodiments, the further device is a suturing device, and the movable device comprises a tissue engagement element.

[0009] In some embodiments, the length of the reconfigurable portion is such that the same user operating the movable device can also operate another device of the system with the same hand or a different hand. In some embodiments, the system includes an endoscope, and the same user can operate the movable device with one hand and reconfigure the reconfigurable portion of the movable device with the same hand or a different hand to maintain the position of the movable device relative to the scope.

[0010] In accordance with various principles of this disclosure, a system for performing medical procedures within a patient's body includes a movable device that is movable relative to another component of the system. In some embodiments, the movable device includes a reconfigurable portion that is reconfigurable by a user relative to at least another component of the system, and an operable component having a tissue engagement element.

[0011] In some embodiments, the tissue engagement element includes a helical tissue engagement element formed from a laser-cut tube. In some embodiments, the movable device includes a flexible control wire, at least a proximal portion thereof, which forms a reconfigurable portion of the movable device.

[0012] In some embodiments, the operable component comprises a tissue engagement element connected to the distal end of a flexible control wire. In some embodiments, the system further includes an endoscope and a suturing device operatively associated with the endoscope, wherein the movable device is movable relative to the suturing device to pull tissue proximal to the needle path of the suturing device.

[0013] In some embodiments, the length of the reconfigurable portion is such that the same user operating the movable device can also operate another device of the system with the same hand or a different hand. In some embodiments, the system includes an endoscope, and the same user can operate the movable device with one hand and reconfigure the reconfigurable portion of the movable device with the same hand or a different hand to maintain the position of the movable device relative to the scope.

[0014] A method for operating a system configured to perform a procedure within a patient, according to various principles of this disclosure, includes moving a first device relative to a component of the system and reconfiguring a reconfigurable portion of the first device relative to a component of the system in order to maintain the position of the first device in a selected position.

[0015] In some embodiments, the first device is a tissue engagement element, the component is a suture device, moving the first device further includes advancing the tissue engagement element into the tissue and retracting the tissue engagement element to draw the tissue into the path of the suture device, and reconfiguring the reconfigurable portion of the first device includes engaging the reconfigurable portion with the components of the system, maintaining the position of the first device, and keeping the tissue in the path of the suture device.

[0016] In some embodiments, the method further includes reconfiguring a reconfigurable portion of the first device to release the movable device from its position engaged with a component of the system.

[0017] In some embodiments, the same user operates the first device with one hand and maintains its position relative to another component of the system with the same hand or the other hand. 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]

[0018] [Figure 1A] This is an elevation view of an example of an embodiment of a system with a movable device, formed according to various principles of the present disclosure and located in a distally extending position. [Figure 1B] Figure 1A is an elevation view of a system equipped with a movable device, where the movable device is positioned in a retracted position near the proximal end. [Figure 1C] Figure 1B is an elevation view of a system with a movable device, where the reconfigurable portion of the movable device is reconfigured to maintain the position of the movable device relative to another component of the system. [Figure 2]An elevation view of an example of an embodiment of a movable device formed in accordance with various principles of the present disclosure. [Figure 2A] A detailed view of region 2A of FIG. 2. [Figure 3] FIG. 3 is an elevation view in an inverted configuration of an example of an embodiment of a system such as FIGS. 1A - 1C. [Figure 4A] An elevation view of an example of an embodiment of a device of a system and a movable device formed in accordance with various principles of the present disclosure, wherein the movable device is in a distally extended position. [Figure 4B] An elevation view of an example of an embodiment of a device of a system and a movable device formed in accordance with various principles of the present disclosure, wherein the movable device is in a proximally retracted position. [Figure 5] A perspective view of an endoscopic suturing system according to an embodiment of the present invention. [Figure 6] A proximal perspective view of the suturing device of the endoscopic suturing system of FIG. 5. [Figure 7] A side view of the suturing device of indeterminate length of the endoscopic suturing system of FIG. 5. [Figure 8] A distal perspective view of a cap assembly attached to the distal end of an endoscope of an endoscopic suturing system. [Figure 9] A distal perspective view of a cap assembly of a suturing device with respect to an endoscope for an endoscopic suturing system. [Figure 10] A cross-sectional view taken along line X - X of FIG. 5. [Figure 11] A distal end schematic view of a cap assembly of a suturing device with respect to an endoscope for an endoscopic suturing system. [Figure 12] A view similar to FIG. 11, showing the endoscope rotated and aligned. [Figure 13] A view similar to FIG. 9, with an endoscope properly oriented and advanced and shown at the distal end of a cap assembly. [Figure 14] A schematic view of a tape applicator. [Figure 15]This is a schematic diagram of a taping system for securing the sheath of a suturing device to an endoscope. [Figure 16] This describes the characteristics of the tape used in the tape system. [Figure 17] This describes the characteristics of the tape used in the tape system. [Figure 18] This is a schematic diagram of an inversion system for an endoscopic system, such as one applied to the proximal handle of the system. [Figure 19] This is a schematic diagram of an inversion system for an endoscopic system, such as one applied to the proximal handle of the system. [Figure 20] This is a schematic diagram showing a detail of one embodiment of a lock for a reversal system. [Figure 21] This is a schematic diagram of an endoscopic system undergoing distal inversion, which is applied by an inversion system. [Figure 22] Figure 16 is a schematic diagram showing the details of the lock's operation. [Figure 23] 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 24] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 25] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 26] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 27] This demonstrates the use of a tape applicator to apply tape to the cap assembly in order to secure the cap assembly to the distal end of the endoscope. [Figure 28] This demonstrates the use of tape along the sheath to secure it to the endoscope. [Figure 29]This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 30] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 31] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 32] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 33] This demonstrates the use of an endoscopic system for endoscopic suturing of tissue. [Figure 34] Figures 30 and 31 show the tape being removed from around the cap assembly. [Figure 35] Figures 30 and 31 show the tape being removed from around the cap assembly. [Figure 36] This shows the disintegration of the sheath from the endoscope. [Figure 37] Figures 11 and 12 show examples of alignment of the cap assembly. [Figure 38] Figures 11 and 12 show examples of alignment of the cap assembly. [Modes for carrying out the invention]

[0019] Non-limiting embodiments of this disclosure are described by reference to the accompanying drawings, which are schematic and not intended to be drawn to any particular scale. The accompanying drawings are provided for illustrative purposes only, and dimensions, positions, order, and relative sizes reflected in the drawings may be modified. For example, a device may be enlarged so that details are identifiable, but is intended to be reduced in relation to mating into a working channel of a delivery catheter or endoscope, for example. For the purposes of clarity and brevity, not all elements are referenced in all drawings, nor are all elements of each embodiment shown where not an example is necessary to enable a person skilled in the art to understand this disclosure.

[0020] 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.

[0021] 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.

[0022] 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 if the element flexes or bends; “axial” generally means being along the longitudinal axis. However, it will be understood that references to axial or longitudinal movement relating to the system or its elements described herein do not need to be strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the element referred to. "Central" means at least approximately bisecting the center point and / or being approximately equidistant from the outer periphery or boundary, and "central axis" means, with respect to an opening, a line that at least approximately bisects the center point of the opening and extends longitudinally along the length of the opening if the opening includes, for example, a tubular element, channel, cavity, or bore. As used herein, "lumen," "channel," "bore," or "passage" are not limited to a circular cross-section. As used herein, the "free end" of an element is the end beyond which such an element does not extend. The terms "at the end," "on the end," "adjacent to the end," or "along the end" may be used interchangeably in this specification without limitation unless otherwise specified, and should be understood as being intended to indicate a general relative spatial relationship rather than a precisely defined location.As understood herein, “corresponding” is intended to convey relationships between components, parts, elements, etc., that are configured to interact with one another or to have different intended relationships with one another. Finally, references to “at” a place or part are intended to include in and / or around such a place or part (e.g., along it, adjacent to it, nearby, etc.).

[0023] Various procedures performed inside a patient's body may be carried out using two or more medical instruments, devices, tools, etc. (such terms are used interchangeably herein without intent to limit them). For convenience and without intent to limit, this disclosure is described with reference to transluminal and / or endoscopic procedures in which devices and / or systems pass through the patient's body through a natural opening or small incision and then through the inside of the patient's body, without cutting the patient to access a target site within the patient's body. Devices and / or systems are typically delivered with the assistance of one or more delivery devices, such as tubular elongated members with a lumen or working channel through which at least one device or system may extend forward, backward, or otherwise movably. It will be understood that the lumen or working channel, etc., may be used interchangeably without intent to limit them. Furthermore, the expression "movably extending" is generally understood to refer to various movements (including, but not limited to, forward or backward in linear, axial, longitudinal, etc.) and / or rotational movements through or within the lumen of a tubular elongated member. Finally, it should be understood that terms such as device, instrument, tool, and component may be used interchangeably without any intention of limitation.

[0024] When a single tubular elongated member is used with a system or method of the Disclosure, one or more devices of the system, or one or more systems, may extend through a common lumen through it. If necessary, at least one device may extend along the outside of the tubular elongated member. In some embodiments, a tubular elongated member with two or more lumens is used with a system or method of the Disclosure, and identical or different lumens are used to allow two or more devices to movably extend through the tubular elongated member. In some embodiments, the tubular elongated member is provided for each device. When more than two devices are used for a procedure, each device may movably extend through its own lumen through the tubular elongated member, or two or more devices may movably extend through a common lumen, or at least one device may extend along the outside of the tubular elongated member. In some embodiments, a single tubular elongated member has two or more lumens, and one or more devices extend through one or more of the lumens. If necessary, one or more additional tubular elongated members may be provided for one or more additional devices used in performing this procedure. Typically, two or more tubular elongated members extend along one another and are optionally connected together so that they can be advanced together to a target site for the procedure. While this disclosure generally describes two or more devices, it should be understood that various principles of this disclosure may also be applied to a single device used without additional devices. Furthermore, it should be understood that various combinations of tubular elongated members, devices, systems, etc. other than those described herein may embody the principles of this disclosure, and that this disclosure is not limited to the examples of embodiments described herein.

[0025] The use of two or more instruments during a medical procedure typically requires coordination of actions performed by or using different instruments. It is desirable that the same (i.e., one) user / operator (e.g., medical professional) can operate, control, manipulate, operate, and use (such terms and other grammatical forms are used interchangeably herein without intent to limit) most, but not all, of the instruments while performing the procedure. In some embodiments, at least one instrument is movable relative to the system's handles. In some cases, the system may include two or more handles (e.g., one for each instrument and / or one for each tubular elongated member that is advanced within the patient and controlled by the user). In some embodiments, the movable instrument is moved by its operator to a desired position relative to various other components of the system. According to various principles of this disclosure, instruments are positionable by the user relative to the system's handles, etc., to maintain the desired position of the instrument relative to other components or devices of the system. In some embodiments, at least a portion of a movable instrument is reconfigurable to hold such reconfigurable portion in a desired position relative to other components / devices of the system. In some embodiments, the reconfigurable portion of a movable device is formable, deformable, or moldable (such terms and other grammatical forms are used interchangeably herein without intent to limit). For example, the reconfigurable portion may be formed into a shape that can hold, or otherwise retain, or fix the movable device to other components / devices of the system. In some embodiments, the reconfigurable portion may be formed into a shape such as a hook, which holds the position of the movable device relative to the proximal end of a tubular elongated member (the proximal opening into the lumen through which the movable device extends). In some embodiments, the reconfigurable portion is reconfigurable to its initial configuration, such as by undoing its deformation.In an embodiment, the reconfigurable portion can optionally be configured to allow rotational movement of the movable device relative to other components / devices of the system, while holding the movable device against longitudinal movement relative to other components / devices of the system.

[0026] In some embodiments, one of two or more devices of the system of the present disclosure is fixed to a flexible elongated member, such as a delivery device, and a movable device (e.g., one described above) is axially translatable and / or rotatably movable relative to the flexible elongated member. In other embodiments, both devices are movable. It will be understood that the present disclosure does not need to be limited in this respect.

[0027] In some embodiments, the movable device is axially translatable and can be advanced and / or retracted relative to the delivery device, for example, distally from and / or into the tubular elongated member. In some embodiments, at least a portion of the tubular elongated member can be articulated, bent, flexed, retroflexed, etc. (such terms and other grammatical forms are used interchangeably herein without intent to limit). For example, the distal portion of the tubular elongated member may be articulated to direct the movable device, which is delivered by the tubular elongated member to a target site in the patient's body. In some embodiments, it is desirable to limit the degree or distance to which the movable device is retracted so that it does not extend excessively deep or proximal to the flexed section of the tubular elongated member (which may make subsequent distal advance from such a position difficult). Various limiters, such as markings, may be provided to help the user of the movable device limit its proximal retraction.

[0028] In some embodiments, the movable instrument is a tissue grasper. Various tissue graspers are known in the art. In some embodiments, tissue graspers formed according to various principles of the present disclosure include a helical element that can be rotated into tissue and then retracted axially proximal (e.g., axially) to grasp and pull the tissue proximal. The present disclosure includes various improvements to tissue graspers to enable their repeated use (grasping, pulling, releasing, etc.) without damaging the tissue or otherwise rendering it inoperable.

[0029] Various embodiments of movable instruments and associated methods for components / devices of a system for performing medical procedures are described with reference to examples shown in the accompanying drawings. References in this specification 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. That is, any of the features, structures, concepts, and / or characteristics described herein may be mixed and adapted to create a hybrid embodiment, and such hybrid embodiment is within the scope of this disclosure. Furthermore, references to “one embodiment,” “embodiment,” “several embodiments,” and “other embodiments” in various parts of this specification do not necessarily all refer to the same embodiment, and separate or alternative embodiments do not necessarily exclude other embodiments from each other. Moreover, it should be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and distinct from one another and may be used or exist individually or in various combinations with each other to create alternative embodiments that are considered part of this disclosure. Accordingly, this disclosure is not limited to the embodiments specifically described herein, and it would be extremely cumbersome to describe all of the numerous possible combinations and partial combinations of features, structures, concepts, and / or characteristics, and the examples of embodiments disclosed herein are not intended to limit broader aspects of this disclosure.The various dimensions provided herein are examples, and those skilled in the art should understand that they can easily determine an appropriate range of standard deviation and acceptable variation therefrom, which are covered by this disclosure and any claims associated therewith. The following description is merely an illustrative example of embodiments and is not intended to limit any broader aspects of this disclosure.

[0030] Referring here to the drawings, Figure 1 shows an example of an embodiment of system 1000 for performing procedures inside a patient's body. The illustrated system 1000 includes a flexible elongated member 1010 that can be inserted into the patient's body (e.g., laparoscopically) either through the lumen of a tubular elongated member (e.g., a tubular delivery device) or by itself, independently of being delivered with the assistance of another device and / or through another device. In the illustrated example of the embodiment, the flexible elongated member 1010 is an endoscope with one or more working channels defined through it. However, the present disclosure is not limited in this way.

[0031] In accordance with various principles of this disclosure, the system 1000 further includes one or more devices that are associated with the flexible elongated member 1010 and configured to be advanced to a target site in the patient. In some embodiments, one or more devices are configured to be used to perform a procedure at a target site in the patient's body. In some embodiments, one or more devices are movable relative to one another. In some embodiments, one or more devices are insertable along or through the flexible elongated member 1010 (e.g., through its lumen or working channel) or attached to it (e.g., fixedly attached to it). In one example of an embodiment illustrated in Figure 1, at least one of the one or more devices is a device 1020 attached to the distal end 1010d of the flexible elongated member 1010. More specifically, in the illustrated example of the embodiment, device 1020 is a suture device attached to an end cap 1022, which is then attached to the distal end 1010d of the flexible elongated member 1010. Further details of an example of an embodiment of a device in the form of a suture device attached to a flexible elongated member 1010 of System 1000 formed according to various principles of the present disclosure are provided below. It should be understood that the present disclosure is not limited to devices fixed to the flexible elongated member 1010 and / or suture device, and the illustrated examples of embodiments are simply examples of various devices that can be used in System 1000 of the present disclosure and / or with the method of the present disclosure. Furthermore, it will be understood that additional movable or fixed devices may be used in addition to, or instead of, device 1020 with System 1000 or the method of the present disclosure.

[0032] In accordance with various principles of this disclosure, system 1000 includes, but is not limited to, a movable device 1100 that is movable relative to other components of system 1000, such as a flexible elongated member 1010. In an example of the embodiment shown in Figure 1A, the movable device 1100 extends substantially longitudinally along the flexible elongated member 1010. More specifically, in an example of the embodiment shown in Figure 1A, the movable device 1100 extends along the outside of the flexible elongated member 1010, rather than through a working channel (if any) of the flexible elongated member 1010. If the flexible elongated member 1010 has a working channel extending through it, such a working channel may therefore be available to accommodate further devices of system 1000 that may extend through it. In some embodiments, such as the examples of embodiments shown in Figures 1A, 1B, and 1C, the movable device 1100 extends through the lumen of an auxiliary tubular elongated member 1030 that extends along (e.g., longitudinally along) the flexible elongated member 1010. In some embodiments, the lumen of the auxiliary tubular elongated member 1030 can function as an auxiliary working channel to the working channel of the tubular flexible elongated member 1010 (e.g., an endoscope). In some embodiments, the auxiliary tubular elongated member 1030 extends through the lumen of a sheath 1032 that is held (e.g., attached) to the flexible elongated member 1010.

[0033] In accordance with various principles of this disclosure, the movable device 1100 is movable relative to one or more components of the system 1000 of this disclosure. For example, in the embodiments shown in Figures 1, 1A, and 1C, the movable device 1100 is movable at least axially relative to the flexible elongated member 1010. For example, as shown in Figure 1A, the movable device 1100 is positioned relative to the flexible elongated member 1010 such that the distal end 1100d of the movable device 1100 extends distally (e.g., from there, outward, beyond, etc.) to the distal end 1010d of the flexible elongated member 1010. As shown in Figure 1B, the movable device 1100 may be moved proximal to the flexible elongated member 1010 such that the proximal end 1100p of the movable device 1100 extends further proximal to the proximal end 1000p of the system 1000 than shown in Figure 1A (for example, relative to the position shown in Figure 1A). As can be understood, such proximal movement of the movable device 1100 causes its distal end 1100d to retract relative to the device 1020. It will also be understood that the movable device 1100 may be rotatable relative to the flexible elongated member 1010.

[0034] In some embodiments, limiters, markers, markings, indicia, etc. (such terms are used interchangeably herein without intent to limit) are included along the proximal portion 1100p of the movable device 1100 to provide, for example, an indication to the operator of how far the movable device 1100 has moved proximal. An example of an embodiment of the movable device 1100 formed according to various principles of this disclosure is shown in Figure 3 with a plurality of indicia 1101 along at least its proximal portion 1100p. The indicia 1101 may be raised, etched, engraved, colored, distinguishable from one another, etc., to facilitate their use during procedures performed using the system 1000. In some embodiments, the indicia indicate the distance the movable device 1100 has moved proximal from another position.

[0035] The movable device 1100 can be used optionally with one or more other devices of the system 1000, in conjunction with them, simultaneously with them, or in succession. For example, the movable device 1100 can be used optionally with a device 1020 attached to the distal end 1010d of the flexible elongated member 1010 and / or the distal end 1000d of the system 1000, such as when the movable device 1100 advances distally beyond the distal end 1010d of the flexible elongated member 1010, as shown in Figure 1A, in conjunction with it, simultaneously with it, or in succession.

[0036] In some embodiments, a system 1000 formed according to various principles of this disclosure can be retroflexed. An example of an embodiment of a retroflexed system 1000 is shown in Figure 3. In the illustrated examples of embodiments, the system 1000 includes an actuation component 1040 which may be referred to herein as a pull string 1040 for convenience and without intent to limit. The pull string 1040 is generally actuated from its proximal end 1040p and has sufficient strength at its distal end 1040d to flex and / or retroflex one or more components of the system 1000, such as the distal end 1010d of a flexible elongated member 1010 and / or the distal end 1100d of a movable device 1100 and / or the distal end 1000d of the system 1000. The pull string 1040 may be formed from a fabric, polymer, or metal monofilament, multifilament, cable twist element, etc., having appropriate strength, selected with reference to its longitudinal range, the flexibility of system 1000 and / or one or more of its components, etc. In some embodiments, the movable device 1100 is movable relative to one or more of the system 1000 even when system 1000 and / or its components are in an inverted configuration as shown in Figure 3. In some embodiments, the indicator portion 1101 may be used as an inversion marker to indicate the distance by which the movable device 1100 is retracted proximally when system 1000 is in an inverted configuration. Such indicators or measurements are useful so that the user can limit the extent to which the movable device 1100 can be retracted proximally, so as not to be retracted proximally beyond a point where it is difficult to advance its distal end 1100d distally through the inversion region of the system 1000 (for example, through the auxiliary tubular elongated member 1030 through which the movable device 1100 extends).

[0037] In some use of the movable device 1100 of the System 1000 of this Disclosure, it may be desirable to maintain a desired position of the movable device 1100 relative to another component of the System 1000. For example, if a distal force is applied to the distal end 1100d of the movable device 1100 during use, it may be desirable to hold the movable device 1100 against being pulled or stretched distally. For example, if the movable device 1100 is configured to grasp tissue and pull / retract the tissue proximal, as described in more detail below, the tissue may resist the proximal gripping force of the movable device 1100 and exert a distal force on the movable device 1100.

[0038] In accordance with various principles of this disclosure, at least a portion of the movable device 1100 is reconfigurable to be maintained in a desired position relative to another component of the system 1000. For example, at least a portion 1102 of the movable device 1100 is reconfigurable to engage with a component of the system 1000 and thereby be held relative to such component. In some embodiments, the reconfigurable portion 1102 is located along or adjacent to a user-engageable portion along the proximal end 1100p of the movable device 1100. In an example of the embodiment shown in Figure 1C, the reconfigurable portion 1102 of the movable device 1100 is provided adjacent to the proximal end 1100p of the movable device 1100 and is reconfigurable relative to the proximal end 1000p of the system 1000. For example, in the embodiment shown in Figure 1C, the reconfigurable portion 1102 of the movable device 1100 may be bent or otherwise deformed relative to another component of the system 1000, such as the proximal end 1030p of the auxiliary tubular elongated member 1030 on which the movable device 1100 extends, and / or a component adjacent to and / or proximal to the proximal end 1030p of the auxiliary tubular elongated member 1030. For example, the reconfigurable portion 1102 may be hooked around the proximal end 1030p of the auxiliary tubular elongated member 1030. However, it will be understood that the bending in the reconfigurable portion 1102 does not need to be as extreme as shown in Figure 1C. In some embodiments, the reconfigurable portion 1102 may be reconfigured by pushing the reconfigurable portion 1102 against the flexible elongated member 1010 (for example, against its handle 1014). Typically, the hand operating the flexible elongated member 1010 (especially the left hand if the flexible elongated member 1010 is in the form of a medical scope) is used to reconstruct the reconfigurable portion 1102.The proximal end 1100p of the movable device 1100 may have a very small profile (even if a handle 1104, as described in more detail below, is provided) so that it can be easily grasped by slightly opening the hand operating the flexible elongated member 1010 when ready to reconfigure the reconfigurable portion 1102 of the movable device 1100. The user can then maintain the position of the movable device 1100 by pushing the reconfigurable portion 1102 against another component of the system 1000 (for example, to prevent the movable device 1100 from inadvertently changing its axial or rotational orientation).

[0039] In some embodiments, the auxiliary tubular elongated member 1030 is positioned within the lumen of the sheath 1032. In an example of the embodiment illustrated in Figure 1C, the lumen of the auxiliary tubular elongated member 1030 and / or the sheath 1032 is accessible via a port 1034 located at the proximal end 1000p of the system 1000, and the reconfigurable portion 1102 of the movable device 1100 is bent or otherwise deformed to hook around the port 1034 so as to be held in place relative to the auxiliary tubular elongated member 1030, as shown in Figure 1C. In some embodiments, the movable device 1100 remains rotatable relative to another component of the system 1000 (e.g., the auxiliary tubular elongated member 1030 through which the movable device 1100 extends) even when it is held in place relative to other components of the system 1000. In some embodiments, the reconfigurable portion 1102 is reconfigurable to free the movable device 1100 from a selected position maintained relative to another component of the system 1000, so as to allow relatively unconstrained movement of the movable device 1100 (e.g., axial and / or rotational movement that is not achievable when the movable device 1100 is held in a fixed position as described above).

[0040] In some embodiments, the movable device 1100 includes an operable component 1110 at the distal end 1100d of the movable device 1100, which can be configured to perform a medical procedure or task. In some embodiments, the movable device 1100 further includes a flexible elongated member 1120, and the operable component 1110 is provided along the distal end 1120d of the flexible elongated member 1120. In some embodiments, a user engagement element, such as a handle 1104, is provided along the proximal end 1120p of the flexible elongated member 1120. In some embodiments, a reconfigurable portion 1102 of the movable device 1100 is formed along or adjacent to the proximal end / proximal portion 1120p of the flexible elongated member 1120 (for example, adjacent to the handle 1104, such as slightly distal to the handle 1104).

[0041] In some embodiments, as shown in Figure 2, the flexible elongated member 1120 includes a sheath 1122, a flexible control wire 1124 extending through it from the proximal end 1100p of the movable device 1100 to the distal end 1100d of the movable device 1100, and a bearing 1126. In some embodiments, the handle 1104 is operatively coupled to the flexible control wire 1124. The sheath 1122, which may be referred to herein as the “control sheath,” may also be operatively coupled to the handle 1104. The control sheath 1122 may extend to any length equal to at least the maximum amount (in some embodiments, about 7 inches / 17.8 cm) that the movable component 1110 extends distally beyond the distal end 1010d of the flexible elongated member 1010. In some embodiments, the control sheath 1122 is formed from a material that can be easily deformed by the user and can be easily moved between a first configuration and a second configuration. In the first configuration, the control sheath 1122 is elongated substantially axially or oriented linearly, which allows the flexible elongated member 1120 to move substantially axially through the lumen of the auxiliary flexible tubular elongated member 1030 (e.g., advancing distally and / or retracting proximally) or through the instrument channel within the flexible elongated member 1010. In the second configuration, the control sheath 1122 is reconfigured to a deformation / bending orientation, etc., that fixes the flexible elongated member 1120 to the auxiliary flexible tubular elongated member 1030 and / or the flexible elongated member 1010. In some embodiments, the control sheath 1122 may be made from a coil catheter wound from stainless steel wire or thermoplastic extruded material (e.g., block copolymers such as Pebax®, formed from rigid polyamide blocks and flexible polyether blocks, nylon, etc.) having sufficient elastic deformation to allow the user to manipulate the control sheath 1122 to ensure the movable device 1100 is in a selected / desired rotational and / or axial position relative to other components of the system 1000. Preferably, the position of the movable device 1100 may be fixed while the user holds and / or controls other components of the system 1000.This allows the user to reconfigure the reconfigurable portion 1102 of the movable device 1100 and operate other components and / or devices and / or accessories of the system 1000 without the need for assistance.

[0042] In some embodiments, the flexible control wire 1124 is formed from a multifilar torque wire wound from multiple strands of a bendable / flexible material such as nitinol, or a wire that can be easily deformed without plastic or permanent deformation (e.g., a metal wire such as steel wire with or without nitinol wire). In some embodiments, the material of the flexible control wire 1124 can transmit axial movement and / or torque from the handle 1104 of the movable device 1100 to a movable component 1110 located at the distal end 1100d of the movable device 1100. For example, the material of the flexible control wire 1124 may be selected to transmit axial or rotational movement of the handle 1104 to a movable component 1110 in the form of a tissue-engaging element, and to engage and disengage from tissue, even when the movable device 1100 / flexible elongated member 1120 is in a bent and / or meandering and / or inverted configuration, as will be described in more detail below.

[0043] In some embodiments, the bearing 1126 is configured and positioned to facilitate the rotation of the flexible control wire 1124 within the bearing 1126 (for example, also within the lumen of the flexible elongated member 1010) in particular when it is advanced through a meandering body passage. Without the bearing 1126, the flexible control wire 1124 would tend to deflect and "whip around" rather than rotate around its longitudinal axis (to advance / retract the tissue engagement element 1110 at its distal end), which could negatively affect the rotational control of the flexible control wire 1124 and / or the tissue engagement element 1110. The bearing 1126 can also impart sufficient column strength to at least the distal portion of the flexible elongated member 1120, such as when the tissue engagement element 1110 extends distally from the flexible elongated member 1010. As a result, the tissue engagement element 1110 can be pushed axially into the tissue before being rotated into the tissue to obtain a sufficiently high retaining force against the tissue at the target site, thereby ensuring initial depth engagement. It will be understood that the bearing 1126 can set the stiffness of at least the distal region of the flexible elongated member 1120. The stiffness imparted by the bearing 1126 may have a preferred range for the movable device 1100 to function as desired. If the stiffness imparted by the bearing 1126 is not sufficiently high, the flexible elongated member 1010 must be controlled very carefully to control the movement of the movable device 1100. Furthermore, if the rigidity is not sufficiently high, the movable device 1100 will generally function very poorly in the tangential direction (for example, when the flexible elongated member 1010 is used tangentially, i.e., when the medical scope cannot be oriented perpendicular to the tissue of the target site), and the tissue engagement element 1110 may slide along the tissue surface (for example, slide along the mucous membrane of the tissue) rather than allowing the tip of the tissue engagement element 1110 to penetrate the tissue (for example, to puncture the tissue when rotated relative to the tissue).In some embodiments, it is preferable that the stiffness provided by the bearing 1126 is sufficient to allow the initial engagement of the tissue engagement element 1110 with the tissue to puncture and penetrate the tissue, and then to allow further distal force to be applied to the movable device 1100 without bending the movable device 1100 (without the tissue engagement element 1110 sliding on the tissue), thereby achieving deeper tissue engagement. However, conversely, if the stiffness provided by the bearing 1126 is too great, the distal end 1100d may be stiff enough to pose a risk of perforation (for example, distal force may be transmitted too easily, causing the tissue engagement element 1110 to extend too deeply into the tissue and potentially perforate the tissue), and / or the stiffness may adversely affect the overall maneuverability of the movable device 1100. In some embodiments, it may be desirable that the movable device 1100 be able to buckle if excessive distal force is applied thereto, for example, to protect the tissue in contact with the tissue engagement element 1110 (e.g., the bearing 1126 allows the movable device 1100 to buckle under certain conditions). In some embodiments, the bearing 1126 is formed to compensate for elongation and / or length as the movable device 1100 is navigated through a meandering body passage. In some embodiments, the bearing 1126 is formed so as not to set / deform when at a tight bending radius (e.g., particularly in a meandering body passage or a high degree of inversion). Thus, the bearing 1126 formed according to the various principles of this disclosure is designed to function in the most extreme conditions in which the movable device 1100 may be used. Although the bearing 1126 is shown as being limited to the distal region of the movable device 1100, it will be understood that in some embodiments the bearing 1126 may extend closer to the proximal end 1100p of the movable device 1100. In some embodiments, some clearance provided at either end of the movable device 1100 makes it possible for the bearing 1126 to "float" and not to be coupled (e.g., with the tissue engagement element 1110 and / or handle 1104).

[0044] In some embodiments, various devices of system 1000 formed according to various principles of the present disclosure have handles corresponding to their respective proximal ends, and the handles are manually graspable by an operator of system 1000 to operate one or more of the devices of system 1000. According to various principles of the present disclosure, the various handles may be associated with one or more components of system 1000. The handles may be positioned sufficiently close to the proximal end 1000p of system 1000 to allow selective operation (e.g., simultaneously and / or sequentially) of two or more devices of system 1000.

[0045] For example, in an example of an embodiment of system 1000 shown in Figures 1A-1C, a handle 1014 may be provided at the proximal end 1010p of a flexible elongated member 1010 to facilitate / control the operation of the flexible elongated member 1010 by an operator of system 1000. For example, in an illustrated example of an embodiment, the flexible elongated member 1010 is an endoscope, and its handle 1014 includes various control knobs and ports (for example, for inserting materials, tools, etc., into the working channel of the flexible elongated member / endoscope 1010). However, the disclosure is not limited to this.

[0046] In the examples of embodiments of the system 1000 shown in Figures 1A-1C, a handle 1024 may be provided along the proximal end 1000p of the system 1000 and used to facilitate / control the operation of the device 1020. For example, in the illustrated example of one embodiment, the handle 1024 includes an actuator 1026 (e.g., a lever arm) that is easily accessible and actuated by the operator's hand. In some embodiments, a transmission 1028 is operatively coupled between the handle 1024 and the device 1020 for the operation of one or more components of the device 1020 by the handle 1024. For example, the device 1020 may include one or more movable components, and the transmission 1028 may be operable to move the components of the device 1020 for use when performing a procedure at a target site in a patient by acting (e.g., moving) the actuator 1026. More specifically, if device 1020 is a suturing device, actuator 1026 can move a suture needle to transmission 1028 to suture tissue at a target site, as in examples of embodiments described in more detail below. However, the disclosure is not limited to this.

[0047] In the example of the system 1000 embodiment shown in Figures 1A to 1C, a handle 1104 is provided on the proximal end 1100p of the movable device 1100 to facilitate / control the operation of the movable device 1100 by an operator of the system 1000. For example, the handle 1104 can be molded to facilitate the axial translation and / or rotation of the movable device 1100 relative to other components of the system 1000, in the various ways described above. For example, the handle 1104 may be molded and / or configured to allow the level of rotational control required for a given medical procedure (e.g., textured, ribbed, notched, etc.). In some embodiments, the handle 1104 is sized, molded, configured, and / or dimensioned so as not to interfere with the hand used by the user to reconfigure the movable device 1100 to be held relative to another component of the system 1000.

[0048] Now, looking at an example of an embodiment of the movable device 1100 shown in Figure 2, the operable component 1110 of the movable device 1100 that is used to perform a task or procedure on a target site, or otherwise usable with the system 1000 to perform a procedure, is the tissue engagement element 1110. With respect to the movable device 1100 at least, terms such as engage, grasp, hold, and other grammatical forms thereof may be used interchangeably herein without intent to limit. In some embodiments, the movable device 1100 may be referred to herein as an alternative tissue engagement device or tissue grasping device. The tissue engagement element 1110 extends distally from the distal end 1100d of the movable device 1100. More specifically, the tissue engagement element 1110 extends distally from the distal end 1120d of the flexible elongated member 1120 of the movable device 1100. An arbitrary handle 1104, such as the handle 1104 described above, may be provided along the proximal end 1100p of the movable device 1100, for example, along the proximal end 1120p of the flexible elongated member 1120.

[0049] In the examples of embodiments shown in detail in Figures 2 and 2A (Figure 2 shows detail 2A), the tissue engagement element 1110 includes a helical tissue engagement portion 1112 extending from the main body 1114. In some embodiments, the tissue engagement portion 1112 is formed with a sufficiently sharp / pointed tip to enable puncture of target tissue. In some embodiments, the tip of the tissue engagement portion 1112 is formed / shaped to a preferred configuration by grinding, honing, laser cutting, etc. In some embodiments, the main body 1114 includes one or more crimp zones 1115 to facilitate crimping of the main body 1114 onto the distal end 1120d of a flexible elongated member 1020 (e.g., onto the distal end of a control wire 1124). The helical configuration of the tissue engagement portion 1112 allows the tissue engagement element 1110 to rotate in the tissue engagement direction (which can be determined, for example, by the direction of the helical winding, as can be understood by those skilled in the art) around the longitudinal axis LA of the tissue engagement element 1110, thereby advancing the tissue engagement element 1110 into the patient's tissue. Similarly, rotation of the tissue engagement element 1110 in the opposite tissue release direction around the longitudinal axis LA of the tissue engagement element 1110 (which can be determined by the direction of the helical winding, as can be understood by those skilled in the art) causes the tissue engagement element 1110 to retract from the patient's tissue.

[0050] In accordance with various principles of this disclosure, the tissue engagement element 1110 is formed from a biocompatible material such as a metal (e.g., medical-grade stainless steel). In some embodiments, the material of the tissue engagement element 1110 is coated with a biocompatible coating such as polytetrafluoroethylene (PTFE). In some embodiments, the tissue engagement element 1110 may be formed from a metal wire (e.g., medical-grade stainless steel, nitinol, titanium, or other formable non-medical-grade metal) or from metal addition manufacturing, or by microforming a material such as a polymer material (e.g., polyetheretherketone (PEEK)). In some embodiments, the tissue engagement element 1110 is formed from a laser-cut tube. In some embodiments, the tube is cut to form a helical winding with substantially constant spacing between them. The constant spacing between the helical windings of the tissue engagement element 1110 may be chosen to allow repeated grasping, release, and re-grasping of tissue at the same or different locations in the patient. For example, the tissue engagement element 1110 may be rotated in a first rotation so that it can be advanced relative to the tissue to grasp the tissue. More specifically, by rotating the tissue engagement element 1110, its helical windings enter the tissue, and as a result, when the movable device 1100 is pulled back proximally, i.e., substantially axially, the tissue engaged by the tissue engagement element 1110 is pulled proximally. Rotating the tissue engagement element 1110 in the opposite direction pulls the helical windings away from the tissue. Since the windings are spaced substantially a constant distance apart from each other, patient tissue is not trapped between the windings, and the tissue engagement element 1110 can rotate out of the tissue without damaging it. The tissue can then be released relatively non-traumatically from the previously grasped tissue (compared to the release of conventional helical tissue engagement elements). The tissue engagement element 1110 can then be rotated again in the tissue engagement direction to grasp the tissue in the same position or a second different position. However, it should be understood that variable spacing between the windings may be desirable for certain applications, and this disclosure is not limited thereto.

[0051] In some embodiments, at least a portion 1116 of the proximal end of the body 1114 of the tissue engagement element 1110 is chamfered so as to be easily retracted into the auxiliary tubular elongated member. In some embodiments, the engagement of the chamfered portion 1116 with the auxiliary tubular elongated member 1030 provides a tactile indication to the user when the tissue engagement element 1110 is retracted into and / or proximal to the distal end 1030d of the auxiliary tubular elongated member 1030, to which the movable device 1100 extends movably.

[0052] In some embodiments, the movable device 1100, including the tissue engagement element 1110, facilitates the performance of a procedure at a first location using a separate instrument. For example, an example of an embodiment of the distal end 1000d of the system 1000, formed according to various principles of the present disclosure, is shown in Figures 4A and 4B, together with the movable device 1100 in the form of a tissue grasping device and the device 1020 in the form of a suturing device. As shown in Figure 4A, the distal advancement of the tissue engagement element 1110 engages the tissue engagement element 1110 with tissue at a target site TS in the patient. As shown in Figure 4B, the tissue at the target site TS is drawn proximal to the path of the needle 1020N of the suturing device 1020 by pulling the movable device 1100 back proximal, substantially axially (the needle 1020N is shown covered under a shroud 1020S positioned to protect the patient's tissue from unintended contact with the sharp tip). Next, the needle 1020N may advance through the grasped tissue and be retracted proximal to the needle path, thereby advancing the suture material held by the needle 1020N through the tissue. Once the suture has passed through the grasped tissue, the movable device 1100 may be rotated in the tissue release direction so as to extend distally and be released from the tissue. The system 1000 can then be advanced to another location and the above operation can be repeated. It will be understood that this disclosure is not limited to suturing tissue grasped by the movable device 1100. Other procedures may be performed with tissue grasped by the movable device 1100 in the form of a tissue grasper, so as to be repeatable at first, second, third, fourth, etc. locations within the patient's body. Incidentally or alternatively, a first procedure may be performed using the movable device 1100 at a first location, and then the system 1000 may be moved to a second location where a second procedure different from the first procedure is performed. The same or different procedures may be performed at a third, fourth, or other location. It will be understood that the movable device 1100 may be operated in conjunction with another device either before, during, or after an action performed by another device.In some embodiments, when the needle 1020N is in the position shown in Figures 4A and 4B, it already has a suture operationally associated with it and therefore moves the suture through the grasped tissue. Alternatively, the needle 1020N is first moved without the suture through the tissue grasped by the movable device 1100 (from the position shown in Figures 4A and 4B) to a position for grasping the suture operationally associated with the device 1020, and then moves back through the tissue to the position shown in Figures 4A and 4B, pulling the suture through the grasped tissue.

[0053] It should be understood that various further devices other than the illustrated examples of embodiments of the movable device 1100 may extend to the flexible elongated member 1010 through the working channels of the flexible elongated member 1010 and / or through the same working channels of the delivery device or separate working channels of the delivery device. In accordance with various principles of this disclosure, any or all further devices may have a proximal end adjacent to the proximal end 1000p of the system 1000 and / or the proximal end 1100p of the movable device 1100, as disclosed herein. The proximal ends of any or all such further devices may be positioned to be accessible by an operator of the system 1000, such that they are accessible while accessing the proximal end of another device at the proximal end 1000p of the system 1000. With the proximal end 1100p of the movable device 1100 held against a component of the system 1000, the handle of the further device can be grasped by the operator of the system 1000 and operated for use during a procedure being performed using the system 1000, leaving the movable device 1100 in a selected position held by its reconfigurable portion 1102.

[0054] It will be understood that the principles of this disclosure may also be applied to reconfiguring other types of movable devices (i.e., devices other than tissue grasping devices as described above) to resist forces acting upon the proximal end of a system, such as an endoscopic system, but not limited thereto. In some embodiments, the proximal end of a movable device may be reconfigurable so that the proximal end can be maintained and released at a selected position relative to the proximal end of the system, making the movable device movable again, and then optionally reconfigured to maintain a selected position relative to the proximal end of the system (a position identical or different from any previously selected position). It will be understood that such reconfiguration of the proximal end of a movable device may be repeated two or more times, as may be determined by the use of the movable device on a patient. The above examples of embodiments of a movable device having a reconfigurable portion extend through an auxiliary flexible tubular elongated member, but it will be understood that the principles of this disclosure may also be applied to extendable devices through a working channel of a flexible elongated member, such as a medical scope, and / or along the outside of a flexible elongated member, such as a medical scope, but not limited thereto.

[0055] 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.

[0056] Referring to Figures 5 to 9, the endoscopic treatment system 10 includes 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 example of the shown embodiment, the endoscope 12 has a single instrument channel 13 and an optical lens 15 (Figure 9). However, since the operation of the system does not necessarily require the use of an instrument channel through the endoscope, the endoscope 12 may have two or more instrument channels, or may not have any instrument channels at all. The endoscope 12 includes a distal end 44, a proximal end 45, and a longitudinal axis A extending between them.

[0057] The suturing system 21 includes a suturing device 22 (Figure 7), a needle assembly 70 (Figure 9) that can move through tissue by the suturing device 22, and first and second devices 38, 40 (Figure 9) used in conjunction with the suturing device 22.

[0058] Referring to Figures 5, 6, and 7, the suturing device 22 has a proximal operable handle 24 with a mounting bracket 26 and a collar 28, at which the handle is detachably coupled to the endoscope 12. The bracket 26 includes first and second instrument ports 30, 32, through which instruments can be received into first and second catheters 34, 36, respectively. First and second tubular connectors 33, 35 are aligned with the ports 30, 32 that connect to the first and second catheters 34, 36.

[0059] 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.

[0060] 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.

[0061] Referring to Figure 9, the cap assembly 50 includes a mount 52, a U-shaped support bracket 54 extending distally from the mount, and a needle arm 58 rotatably mounted on the bracket 54 using a first pin 60. A bell crank 64 is rotatably attached to the support bracket 54 at a second pin 66 and engages with the needle arm 58 in a meshing gear (not shown). The distal end of the transmission cable 48 of the transmission assembly 42 is attached to the bell crank 64 by a clevis 68. When the transmission assembly 42 is operated by the handle 24, the bell crank 64 rotates, causing the needle arm 58 to rotate between an open position and a closed position.

[0062] 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.

[0063] Referring to Figures 8 and 9, 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.

[0064] Referring to Figures 7 and 10, the distal end of the first catheter 34 is fixed in a first through bore 86, and its proximal end is connected to a first connector 33 on the handle bracket 26. The distal end of the second catheter 36 is fixed in a second through bore 88, and its proximal end is connected to a second connector 35 on the handle bracket 26. The first and second catheters 34, 36 may be separate catheters or separate lumens of a common catheter. In a preferred embodiment, the catheters 34, 36 are separate catheters covered along substantially all of their total length (i.e., at least 80 percent, more preferably at least 90 percent) by a preferably crescent-shaped common sheath 89. Alternatively, the common sheath 89 may extend along the total length of the catheters 34, 36, along the length of a portion thereof, or may be provided in segments along selected portions of the catheters 34, 36. In a preferred embodiment, the common sheath 89 is flexible and defines a lumen 90 for the catheter 34, a lumen 92 for the catheter 36, and a lumen 94 for both the transmission assembly 42 and the inverting pull string 100, the functions of which are described below. If necessary, separate lumen may be provided for the transmission assembly 42 and the pull string 100. A recessed area 96 is provided along the length of the sheath 89, and it is preferable that the sheath be able to extend close to the outside of the endoscope 12 of appropriate dimensions. In one embodiment, the sheath 89 is adapted to accommodate the endoscope by extending more than 180° around the circumference of the endoscope 12, which is preferably of appropriate dimensions, thereby partially surrounding the outside.

[0065] Referring to Figures 7 and 8, 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.

[0066] Referring to Figure 9, 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 with 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.

[0067] Referring to Figures 9, 11, 12, and 13, a stop 106 is formed at the distal end of the clip 102. The distal end 44 of the endoscope 12 is pushed into a recess 104 of the clip 102 and fitted to seat against the stop 106. The stop 106 is preferably formed around the stop 106 as a first recess 108 and includes a largest first clearance window that allows passage access to the instrument channel 13 on various endoscopes from multiple manufacturers when the endoscope is properly rotatably aligned within the clip 102, and smaller second and third clearance windows formed on either side of the first recess 108 at approximately 60°, which prevent interference with the optical lens 15 and other working features of various endoscopes. The first recess 108 is located radially inward of the instrument channel lumen 88. To align the endoscope feature with respect to the first, second, and third recesses 108, 110, and 111, the stopper 106 includes a guide 112 to which the instrument channel 13 or other designated feature of the endoscope is rotationally aligned. For example, if the endoscope does not include an instrument channel 13 (and is therefore not required in the system described herein), the optical lens may be designated to align with the guide 112. In a preferred embodiment, the guide 112 is a color contrasting with the color of most of the cap assembly provided around the first recess 108. By thus rotationally aligning the designated endoscope feature with respect to the guide 112 (in the direction of arrow 115), the optical lens 15 of the endoscope ensures an unobstructed field of view and proper orientation with respect to the suturing arm 58, instrument channel lumen 88, and needle exchange lumen 86 without the need to activate the endoscope, regardless of the type of endoscope from the primary manufacturer used with the system. In other words, the relative orientation, access, and field of view can be confirmed without the need to power on the endoscope and preview the field of view from the lens 13 on the display 14 prior to the procedure. This significantly reduces the preparation time before the procedure.The positions of the first and second recesses 108, 110 and the indicator section 112 relative to the suturing arm 58, the instrument channel lumen 88, and the needle exchange lumen 86, as well as the area covered by the distal end of the endoscope and obscured from the field of view, are based on the analysis of scans of multiple distal ends of the endoscope.

[0068] Referring to Figure 13, 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.

[0069] Referring to Figure 14, 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.

[0070] Referring here to Figures 15, 16, and 17, 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 16). According to one embodiment of the system, the strip 140 is provided with at least one perforation 152 that allows for break-away disassembly of the system after use (Figure 17).The perforations 152 are preferably provided at or near the joint between the second portion 142 and the third portion 144 of the tape.

[0071] Referring to Figures 7, 18, and 19, 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 7) 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 8). 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 20).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 21, 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 22). 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 18). 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.

[0072] 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 9). 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 11 and 12). The endoscope 12 is then pushed in completely, if necessary, until it contacts the distal stop 106 (Figure 13).

[0073] Next, referring to Figures 23, 24, and 25, 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 the tape 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 26 and 27, 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.

[0074] Next, referring to Figures 10, 16, 17, and 28, the endoscope is fully pushed into the recess 96 along the length of the sheath 89. Starting from the distal end of the system, on strip 140a of tape, the tab 148 of the protective strip is peeled off to expose the adhesive portion 144, and with tape 140 taut, the first portion 142 of the tape is wrapped around the endoscope 12, the second adhesive portion 144 of the tape is adhered to the sheath on the opposite side of the recess 96, and then extended again to cover the tape and secure the endoscope there. To properly secure the sheath to the endoscope, this process is repeated along the length of the sheath for the remaining strips 140c, and then 140b. This secures the sheath 89 longitudinally outside the endoscope 12 for in vivo operation.

[0075] The collar 28 is appropriately positioned on the proximal handle 45 of the endoscope 12. The first device, a needle capture instrument 38 loaded with a needle assembly 70, is advanced through the first port 32 into the first lumen 34 to the cap assembly 50. A preferred needle capture device 38 is described in detail in U.S. Patent No. 8,679,136, which is incorporated herein by reference in whole for all purposes. The needle assembly 70 is loaded on a needle arm 58, and the suture 78 extends parallel to the needle capture instrument 38 within the first lumen 34.

[0076] Referring to Figures 15 and 29, 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 28. Referring to Figure 30, 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 7), exits the second through bore 88 (Figure 8), 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 31. 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 32). 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 8). 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 33).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.

[0077] 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 34 and 35. Next, referring to Figure 36, 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 17), 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] In some embodiments, the cap assembly is a suture assembly that includes a movably mounted needle holder. In some embodiments, the operation of the proximal handle assembly moves the needle holder on the cap assembly.

[0091] According to various principles of 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.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] 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.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] 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.

[0114] Those skilled in the art will understand that this discussion is merely a description of exemplary embodiments and is not intended to limit broader aspects of the present disclosure. All apparatus and methods discussed herein are examples of apparatus and / or methods implemented in accordance with one or more principles of this disclosure. These examples are merely illustrative and not the only ways of implementing these principles, and are not intended to limit the broader aspects of this disclosure. Accordingly, references to elements, structures, or features in the drawings should be recognized as references to examples of embodiments of this disclosure, and this disclosure should not be understood as limiting to the specific elements, structures, or features illustrated. Other examples of ways of implementing the disclosed principles will be apparent to those skilled in the art upon reading this disclosure. It should be obvious to those skilled in the art that modifications may be applied to the disclosed devices, systems, and / or methods, and / or sequences of steps of the methods described herein, without departing from the concepts, spirit, and scope of this disclosure. Various features described in relation to one embodiment will typically be applicable to another embodiment, whether expressly indicated or not. The various features described below may be used individually or in any combination thereof. Accordingly, the present invention is not limited to the embodiments specifically described herein, and all substitutions and modifications obvious to those skilled in the art are considered to be within the spirit, scope, and concept of this disclosure as defined by the appended claims. In addition to those described above, various further advantages of the various aspects, features, components, and structures of the devices and systems described above may be understood by those skilled in the art.

[0115] 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.

[0116] 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.

[0117] The following claims are incorporated by this reference into this detailed description, and each claim stands alone as a separate embodiment of the present disclosure. In the claims, the terms “comprises,” “comprising,” “includes,” and “including” do not exclude the existence of other elements, components, features, groups, areas, integers, steps, operations, etc. In addition, individual features may be included in different claims, but they may be advantageously combined in some cases, and inclusion in different claims does not mean that the combination of features is not feasible and / or unfavorable. In addition, singular references do not exclude plurals. Reference numerals in the claims are provided merely as examples for clarity and should not be construed as limiting the claims in any way.

Claims

1. A system for performing medical procedures inside a patient's body, wherein the system is: A flexible, elongated member that can be inserted into a target site inside the patient's body, The system includes a movable device that is movable relative to the flexible elongated member, The movable device is a system that includes a reconfigurable portion of at least a part of the flexible elongated member that can be reconfigured by a user.

2. The system according to claim 1, wherein the reconfigurable portion can be configured with respect to the flexible elongated member to maintain a selected position of the movable device with respect to the flexible elongated member.

3. The system according to any one of claims 1 to 3, wherein the reconfigurable portion is bendable with respect to the flexible elongated member, or otherwise deformable.

4. The system according to any one of claims 1 to 3, wherein the flexible elongated member is a medical scope.

5. The system according to claim 4, further comprising an auxiliary flexible tubular elongated member that is extendable along the medical scope and defines a lumen from which the movable device can move.

6. The system according to claim 4, wherein the movable device is movable through a work channel defined through the medical scope.

7. The system according to any one of claims 1 to 6, wherein the movable device includes at its distal end an operable component configured to engage with tissue, and the tissue engaged by the operable component exerts a distal force on the movable device.

8. The system according to claim 7, wherein the operable component is a helical structure engagement element.

9. The system according to any one of claims 1 to 8, wherein the reconfigurable portion is adjacent to the user-engageable portion of the movable device.

10. The system according to any one of claims 1 to 9, further comprising a suturing device, wherein the movable device comprises a tissue engagement element.

11. A system for performing medical procedures inside a patient's body, wherein the system is: The system includes a movable device that can be moved relative to another component of the system, The aforementioned movable device is: The system comprises at least one reconfigurable portion that can be reconfigured by a user with respect to the other components, A movable component having tissue engagement elements, A system equipped with these features.

12. The system according to claim 11, wherein the tissue engagement element comprises a helical tissue engagement element formed from a laser-cut tube.

13. The system according to claim 11 or 12, wherein the movable device comprises a flexible control wire, at least a proximal portion thereof forming the reconfigurable portion of the movable device.

14. The system according to claim 13, wherein the operable component comprises a tissue engagement element connected to the distal end of the flexible control wire.

15. The system according to any one of claims 11 to 14, further comprising an endoscope and a suturing device operatively associated with the endoscope, wherein the movable device is movable relative to the suturing device to pull tissue proximal into the needle path of the suturing device.

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