Grappling system and method for lumen apposition or wound defects

Abstract

To provide a tissue-manipulating system including a tissue-manipulating device having a shaft and a tissue grasper assembly.SOLUTION: A tissue grasper assembly has at least one grasper arm resiliently expandable from a closed configuration, extending within the shaft along a longitudinal axis of a shaft, to an open configuration outside the shaft with the grasper arm expanded in a direction transverse to the longitudinal axis of the shaft. In the open configuration, the at least one grasper arm may be engaged with a tissue wall to manipulate or move the tissue wall, such as to move a distal tissue wall closer to a proximal tissue wall. The tissue grasper assembly may be deployable (for example, by being separated from the shaft), so as to remain in place by holding two tissue walls in apposition.SELECTED DRAWING: Figure 2E

Description

Technical Field

[0001] The present disclosure generally relates to devices and methods for manipulating tissue walls, accessing tissue walls, and / or maintaining tissue walls in an adhered and compressed state.

Background Art

[0002] Access to tissue is useful for various purposes in many medical procedures. Many medical procedures require moving a tissue wall (e.g., a body lumen wall or an organ wall) to a desired position, such as against another tissue wall, to form an anastomosis between adjacent body lumens or to repair body tissue. Difficulties arise when moving a lumen towards another lumen and holding the two in place.

[0003] Therefore, improved tools, devices, systems, and methods for manipulating and moving body organs, tissues, lumens, etc. would be welcomed in the medical field.

Summary of the Invention

[0004] This summary of the disclosure is provided to facilitate understanding and it will be appreciated by those skilled in the art that each of the various aspects and features of the disclosure can advantageously be used, in some examples separately or in other examples in combination with other aspects and features of the disclosure. It is not intended that the scope of the claimed subject matter be limited by whether elements, components, etc. are included or not included in this summary.

[0005] The present disclosure is directed to tissue manipulation devices and systems capable of manipulating, clamping, grasping, approaching, attracting, pulling, holding, etc. (such terms are used interchangeably herein without intent to limit). Optionally, the devices and systems can be used to hold tissue together in an adhesion and compression state. It is desirable to provide improved protocols and access for pulling tissue together, such as to form an anastomosis or repair tissue, as well as tissue grasping / tissue clamping tools, devices, and systems. It is further desirable to provide protocols, tools, devices, and systems that facilitate a faster method for forming an anastomosis. It is further desirable to provide protocols, tools, devices, and systems for holding tissue in an adhesion and compression state (while also minimizing any risk of leakage between tissues).

[0006] In one aspect, the present disclosure relates to a tissue manipulation device comprising a shaft having a longitudinal axis, a tissue grasper assembly, and a controller. In some embodiments, the tissue grasper assembly includes one or more elastic grasper arms that are extensible between a closed configuration, in which the one or more grasper arms extend along the longitudinal axis of the shaft within the shaft, and an open configuration outside the shaft in which the one or more grasper arms extend laterally away from the longitudinal axis of the shaft. In some embodiments, a grasper surface is associated with at least one of the grasper arms and is shaped and configured to engage body tissue. In some embodiments, at least one grasper arm is in the open configuration, the grasper surface is in contact with body tissue, and when the tissue manipulation device is moved in the proximal direction, the tissue manipulation device moves the body tissue in the proximal direction as well. In some embodiments, the controller is coupled to the tissue grasper assembly via a controller coupler and is configured to operate the grasper arms between the closed configuration and the open configuration.

[0007] In some embodiments, when disposed outside the shaft, the grasping arm is elastically biased into an open configuration in a radially outward direction away from the shaft. In some embodiments, the grasping arm is elastically held in the open configuration by a directional conversion feature formed on the distal end of the shaft.

[0008] In some embodiments, the tissue grasping assembly is separable from the shaft and the controller so as to remain in place while grasping body tissue. In some additional embodiments, the tissue grasping assembly includes a locking mechanism engageable to hold at least one grasping arm engaged with the tissue when the tissue grasping assembly is separated from the shaft and the controller. In some additional or alternative embodiments, the tissue manipulation device further includes a controller coupler coupled between the grasping arm and the controller and movable to operate at least one grasping arm between a closed configuration and an open configuration upon actuation of the controller, and the controller is separable from the controller coupler for implanting the tissue grasping assembly. In some alternative or additional embodiments, the tissue grasping assembly further includes a capsule coupled to the shaft, the grasping arm is coupled to the shaft via the capsule, and the tissue grasping assembly is separable from the shaft and the controller together with the capsule so as to remain in place while grasping body tissue.

[0009] In some embodiments, at least one of the grasping arms includes a tissue grasping feature that faces in a proximal direction toward the shaft when the grasping arm extends distally outside the shaft and expands into the open configuration.

[0010] In some embodiments, the tissue manipulation device further includes a sharp element extending distally from the distal end of the tissue grasping assembly and configured to pierce the body tissue wall.

[0011] In some embodiments, the grasping arm is in the form of a wire that is elastically biased, and the grasping surface is provided on a tissue holding mechanism associated with the grasping arm.

[0012] According to another aspect, the present disclosure relates to a tissue grasping device assembly comprising a capsule having a longitudinal axis, one or more elastic grasping arms, and a controller coupler. In some embodiments, the one or more grasping arms are extensible between a closed configuration, in which the one or more grasping arms extend along the longitudinal axis of the capsule within the capsule, and an open configuration outside the capsule in which the one or more grasping arms extend laterally away from the longitudinal axis of the capsule. In some embodiments, a grasping surface is associated with at least one of the grasping arms and is shaped and configured to engage body tissue. In some embodiments, the controller coupler is coupled to at least one of the grasping arms and is movable to operate the at least one grasping arm between the closed and open configurations.

[0013] In some embodiments, the tissue grasping device assembly further comprises a locking mechanism engagable to hold the tissue grasping device assembly in a configuration engaged with the tissue. In some embodiments, the capsule is configured to couple to the distal end of a shaft.

[0014] In some embodiments, the capsule has a proximal end and a distal end, and one or more grasping arms extend from each of the proximal and distal ends of the capsule. In some embodiments, the tissue grasping device assembly further comprises a sharp element extending distally from the tissue grasping device assembly and configured to pierce a body tissue wall.

[0015] In some embodiments, at least one of the grasping arms is elastically held in the open configuration by a direction changing feature formed on the distal end of the shaft. In some embodiments, one or more of the grasper arms have a tissue grasping feature configured to engage tissue.

[0016] According to another aspect, the present disclosure relates to a method of manipulating tissue using a tissue manipulation device, the method comprising: extending a tissue manipulation device comprising a shaft having a longitudinal axis and a tissue grasper assembly through a distal tissue wall to move a distal end of the tissue manipulation device distal to the distal tissue wall; actuating a tissue manipulation device controller; and moving the tissue manipulation device proximally to move the distal tissue wall proximally. In some embodiments, the tissue grasper assembly comprises at least one resiliently extendable grasper arm in a closed configuration extending along and within the shaft as the tissue manipulation device extends through the distal tissue wall. In some embodiments, actuating the tissue manipulation device controller comprises extending the at least one resiliently extendable grasper arm from an interior side of the shaft to an exterior side of the shaft to allow the at least one resiliently extendable grasper arm to expand to an open configuration extending transversely to the longitudinal axis of the shaft. In some embodiments, moving the tissue manipulation device proximally causes at least one grasper arm to engage the distal tissue wall and move the distal tissue wall proximally.

[0017] In some embodiments, the method further includes extending the tissue manipulation device through the proximal tissue wall before extending the tissue manipulation device through the distal tissue wall, and moving the tissue manipulation device in a proximal direction to move the distal tissue wall into adherent compression against the proximal tissue wall.

[0018] In some embodiments, the method further includes separating the tissue grasper assembly from the shaft to deploy the tissue grasper assembly holding the proximal and distal tissue walls in adherent compression.

[0019] These features and advantages of the present disclosure, as well as other features and advantages, will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. The following disclosure is presented from the perspective of aspects or embodiments, but it should be understood that individual aspects can be claimed separately or in combination with aspects and features of their embodiments or any other embodiments.

[0020] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be shown to an exact scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected in the figures in the drawings may be changed. For example, a device may sometimes be enlarged so that details can be distinguishable, but it is also intended to be reduced, for example, in relation to fitting within a delivery catheter or the working channel of an endoscope. In these figures, identical, or nearly identical, or equivalent elements are typically represented by the same reference characters, and similar elements are typically designated by similar reference numbers that differ by a unit of 100, and redundant descriptions are omitted. For the purposes of clarification and simplification, not all elements in all figures are labeled, and not all elements of each embodiment are shown when illustration is not necessary for those skilled in the art to understand the present disclosure.

[0021] The detailed description will be better understood in conjunction with the following accompanying drawings in which like reference characters represent like elements.

Brief Description of the Drawings

[0022]

Figure 1

Figure 2A

Figure 2B

Figure 2C

Figure 2D

Figure 2E

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 4C

Figure 4D

Figure 5A

Figure 5B

Figure 5C

Figure 6A

Figure 6B

Figure 6C

Figure 7A

Figure 7B

Figure 7C

Figure 8A

Figure 8B

Figure 8C

Figure 9A

Figure 9B

Figure 9C

Figure 10A

Figure 10B

Figure 10C

Figure 11A

Figure 11B

Figure 12A

Figure 12B

Figure 13A

Figure 13B

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19A

Figure 19B

Figure 19C

Figure 19D

Figure 19E

Figure 20A

Figure 20B

Figure 20C

DETAILED DESCRIPTION OF THE INVENTION

[0023] The following detailed description should be read with reference to the drawings that illustrate exemplary embodiments. The present disclosure is not limited to the specific embodiments described, and thus it should be understood that it may be changed. All of the apparatuses, systems, and methods discussed herein are examples of apparatuses, systems, and / or methods implemented in accordance with one or more principles of the present disclosure. Each example of an embodiment is provided for the sake of explanation and is not the only way to implement these principles, but merely an example. Therefore, references to elements, structures, or features in the drawings should be understood as references to examples of embodiments of the present disclosure and should not be understood as limiting the present disclosure to the specific elements, structures, or features shown. Those skilled in the art will envision other examples of ways to implement the disclosed principles upon reading the present disclosure. In fact, it will become apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from the scope or spirit of the subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still further embodiments. Therefore, the subject matter is intended to embrace such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0024] In this application, it will be understood that the present disclosure is described in detail at various levels. In certain instances, details that are not essential for those skilled in the art to understand the present disclosure, or details that make it difficult to recognize other details, may be omitted. The terms used herein are for the purpose of describing only specific embodiments and are not intended to limit beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as being generally understood by those skilled in the art to which the present disclosure pertains. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation based on the present disclosure.

[0025] As used herein, "proximal" refers to the direction or location that is closest to the user (such as a medical professional, clinician, technician, surgeon, or physician, such terms being used interchangeably without intention of limitation or otherwise) when using the device (e.g., when introducing the device into a patient, or during implantation, positioning, or delivery), and "distal" refers to the direction or location that is farthest from the user when using the device (e.g., when introducing the device into a patient, or during implantation, positioning, or delivery). "Longitudinal" means extending along the longer dimension or greater dimension of an element. "Central" means intersecting at least generally with a central point, and "central axis", with respect to an opening, is a line that intersects at least generally with the central point of the opening and, when the opening includes, for example, a tubular element, channel, or hole, is a line that extends longitudinally along the length of the opening.

[0026] As will be described with reference to the drawings, devices, systems, and methods for manipulating tissue walls, approaching tissue walls, and / or maintaining tissue walls in an adherent and compressive state at a treatment site are disclosed herein. The medical devices, instruments, tools, etc. of the present disclosure may include, without limitation, various medical devices for accessing body passages, such as, for example, duodenoscopes, catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, etc. As used herein, reference will be made to terms such as operating and / or other terms such as clamping, grasping, approaching, attracting, pulling, holding, etc., but it should be understood that such terms are used interchangeably herein without intending to be limiting. Without limitation, tissue walls, such as organ walls or lumen walls, can be brought together and / or attracted to another tissue wall, for example, to form an anastomosis, for example, to hold the tissue walls in an adherent and compressive state. For example, the devices and systems of the present disclosure can engage a portion of the small intestine and pull it toward the stomach wall, such as by piercing through the walls of the small intestine and stomach, and hold their lumens / tissues together. Such methods and devices can also be used, similarly, for access to and from various portions of the urinary tract, such as the bladder and ureters, the pulmonary tract, such as the trachea and bronchi, and the biliary tract, such as the bile ducts and gallbladder, as well as for uses related to blood vessels. Alternatively, the distal ends of tissue walls can be attracted together to close a defect therebetween. It will be understood that the present disclosure should not be construed as being limited to such procedures or end results. Further, although a treatment site is mentioned, such mention is for convenience only and is not intended to limit the scope of the present disclosure.

[0027] According to various principles of the present disclosure, the distal end of the tissue manipulation device has a generally hollow elongated member such as a catheter, cannula, hollow shaft (referred to herein as a shaft for simplicity and without intent to limit). One or more gripper arms can extend through the elongated member. In some embodiments, the shaft is in the form of a collar or capsule. In some embodiments, the shaft is formed separately from and coupled to the shaft and optionally removable from the shaft for placement of a tissue gripper assembly (including the gripper arms) of the tissue manipulation device. It includes a collar or capsule (such terms are used interchangeably herein without intent to limit). The gripper arm is operable between a closed configuration (inside the shaft and generally extending along the longitudinal or axial extent of the lumen defined within the shaft and the shaft) and an open configuration where the gripper arm expands or extends away from the shaft, for example, to engage a tissue wall. In some embodiments, the gripper arm is elastically biased to be held, for example, in an open configuration capable of engaging tissue. In some embodiments, the gripper arm is elastically biased to expand or otherwise extend into the open configuration when released or placed from the shaft. In other embodiments, another element of the tissue manipulation device can hold the elastically biased gripper arm in the open configuration.

[0028] The tissue manipulation device can be advanced through a working channel of a delivery device, such as a flexible elongate member (e.g., a catheter, an endoscope, a cannula, a delivery shaft, etc., and in this specification, the term "flexible elongate member" is generally used to refer to a delivery device without intending to limit it for convenience), of an operating system for the tissue manipulation to a treatment site. The gripper arm can be controlled (e.g., advanced to a second configuration for engaging tissue beyond the distal end of the shaft) by a tissue manipulation device controller extending along the flexible elongate member from the proximal end to the distal end of the flexible elongate member (e.g., through the flexible elongate member or along the outside of the flexible elongate member). The distal end of the tissue manipulation device controller controls the operation of the gripper arm by being coupled to or engaged with at least one gripper arm, as desired or as directed by the procedure in which the tissue manipulation device is being used. The proximal end of the tissue manipulation device controller can be engaged with, coupled to, or otherwise associated with a control handle associated with the tissue manipulation system to facilitate the operation of the tissue manipulation device controller as well as other components of the tissue manipulation system. One of various control handles known or publicly known in the art can be used to operate the tissue manipulation device controller (as well as other components or structures of the tissue manipulation system) through its proximal end or the like, and the specific details of its configuration do not limit the scope of the present disclosure. In some embodiments, the gripper arm can be operated between a closed configuration and an open configuration by advancing the tissue manipulation device controller in a distal direction or retracting it in a proximal direction to manipulate the position of the gripper arm relative to the shaft.

[0029] Various features can be provided to facilitate grasping, clamping, moving, etc. of tissue (such terms are used interchangeably herein without intent to limit). According to some embodiments described herein, at least one of the grasping arms can be shaped and configured to enhance tissue engagement and / or grasping. In some embodiments, the free end (e.g., distal end) of at least one of the grasping arms is shaped and configured to enhance tissue engagement and / or grasping, such as by hooking onto the tissue. In some embodiments, one or more tissue grasping features, such as hooks, are provided along one or both of the grasping arms, between the attachment end (the end coupled to the remainder of the tissue manipulation device, such as the proximal end of the grasping arm) and the free end of the grasping arm.

[0030] According to some embodiments disclosed herein, the distal end of the tissue manipulation device can be configured to facilitate passage of its distal end through the tissue wall to be operated on. In some embodiments, the distal end of the tissue manipulation device is provided with a sharp end, such as a needle or other sharp element, capable of piercing the tissue wall. In some embodiments, this sharp end can be associated with the shaft and / or the grasping arms.

[0031] According to some embodiments disclosed herein, the grasping arms can be coupled to a tissue grasping assembly configured to be releasable from a tissue manipulation device controller for leaving the approaching tissue in a state where the tissue grasping assembly holds them in an adhered and pressed state to each other. Additional embodiments of tissue graspers are also disclosed that can be left in place at a predetermined location to hold tissues together (e.g., bringing together the walls of different organs or lumens, or repairing a defect and holding together the tissues surrounding the defect).

[0032] Next, various embodiments of the tissue manipulation device, system, and method are described with reference to the examples shown in the accompanying drawings. References to "one embodiment", "an embodiment", "some embodiments", "other embodiments", etc. in this specification indicate that one or more specific features, structures, and / or characteristics according to the principles of the present disclosure may be included in that embodiment. However, such references do not necessarily mean that all embodiments include that specific feature, structure, and / or characteristic, or that an embodiment includes all features, structures, and / or characteristics. Some embodiments may include one or more such features, structures, and / or characteristics in various combinations. Furthermore, references to "one embodiment", "an embodiment", "some embodiments", "other embodiments", etc. in various places in this specification do not necessarily all refer to the same embodiment, and distinct or alternative embodiments are not necessarily mutually exclusive of other embodiments. If a particular feature, structure, and / or characteristic is described in relation to one embodiment, it should be understood that such feature, structure, and / or characteristic can also be used in relation to other embodiments, whether or not it is explicitly described, unless specifically stated otherwise. Such features, structures, and / or characteristics may be used or presented alone, or may be used or presented in various combinations with each other to create alternative embodiments that are considered part of the present disclosure, as it would be too cumbersome to describe all possible combinations and sub-combinations of features, structures, and / or characteristics. Furthermore, various features, structures, and / or characteristics are described that may be presented by some embodiments but not by other embodiments. Similarly, various features, structures, and / or characteristics or requirements are described that may be features, structures, and / or characteristics or requirements for some embodiments but not for other embodiments. Therefore, the present invention is not limited to only the embodiments specifically described herein.

[0033] Referring now to the drawings, a tissue manipulation system 100 formed in accordance with the principles of the present disclosure, such as to create an anastomosis between the stomach S and a portion of the small intestine SI, such as the jejunum J, is shown in a schematic view of the gastrointestinal system. This gastrointestinal system is merely one of several anatomical sites where it is possible to use the tissue manipulation system 100 formed in accordance with the principles of the present disclosure, and it will be understood that this particular anatomical site does not affect the scope of the present disclosure, nor does it limit the disclosed tissue manipulation system 100. The tissue manipulation system 100 can include a delivery device, such as a flexible elongate member 102 (as used herein, the term "flexible elongate member" is used generally to refer to a delivery device without intending to be limiting for convenience), such as an endoscope, cannula, delivery shaft, etc., which has a working channel extending therethrough and through which a tissue manipulation device 110 is guided to a treatment site TS. The tissue manipulation device 110 includes a tissue grasper assembly 120 configured to engage tissue to be manipulated by the tissue manipulation device 110 at a tissue manipulation device distal end 111. A tissue manipulation device controller 130 (schematically shown by a virtual line extending through the flexible elongate member 102) extends from the tissue grasper assembly 120 to a proximal end 113 of the tissue manipulation device 110 for access and operation by a user (e.g., a medical professional such as a physician, technician, endoscopist, etc., and / or an automated system or other) to control the tissue grasper assembly 120. The tissue manipulation device 110 can be positioned relative to the tissue manipulation system 100 such that the tissue grasper assembly 120 extends from a distal end 101 of the tissue manipulation system 100 and a proximal end 133 of the tissue manipulation device controller 130 is positioned at or along a proximal end 103 of the tissue manipulation system 100.The control handle 104 can be provided at the proximal end 103 of the tissue manipulation system 100 and associated with the tissue manipulation device controller 130 and / or a controller of the flexible elongate member 102 (any controller that is known or publicly known in the art and not shown since it is not essential for a complete understanding of the tissue manipulation device 110).

[0034] The tissue manipulation device 110 is configured to be delivered through the flexible elongate member 102 to the treatment site TS in accordance with known or publicly known techniques for advancing the device or system through the patient's anatomical structure to the treatment site TS. The distal end 111 of the tissue manipulation device 110 can have an outer shape configured to easily pass through an opening that penetrates the proximal tissue wall and the distal tissue wall, as can be understood with reference to the various embodiments of the tissue manipulation devices and tissue gripper assemblies disclosed herein (e.g., see FIG. 2). The distal end 111 of the tissue manipulation device 110 can be configured to easily pass through an opening or passage designated for the tissue manipulation device 110 (e.g., created for or by the tissue manipulation device, as discussed in more detail below) without causing any unwanted damage (e.g., abrasions, lacerations, tears, etc.). In some embodiments, the distal end 111 of the tissue manipulation device 110 is configured to pierce the tissue wall and then pass through the puncture, as described in more detail below.

[0035] According to one aspect of the present disclosure, the tissue grasping assembly 120 includes one or more grasping arms 122 supported by a shaft 116 for delivery to a treatment site TS through a flexible elongate member 102 or the like. The grasping arms 122 can be delivered in a closed configuration stored within the shaft 116 and have an outer profile small enough to be moved distally through the tissue manipulation system 100. The tissue manipulation device controller 130 is operable (e.g., actuatable) to actuate the tissue grasping assembly 120 to move the grasping arms 122 from a closed configuration to an open configuration that provides a grasping surface having a sufficient surface area configured and shaped to engage the tissue to be manipulated such that the grasping arms 122 extend and / or protrude away from the shaft 116. In some embodiments, the tissue manipulation device controller 130 is moved in a distal or proximal direction to actuate the grasping arms 122. However, other operations or controls of the tissue manipulation device controller 130 are also within the scope of the present disclosure, and these particular operations are not determinative of the broad principles of the present disclosure.

[0036] An example of an embodiment of a tissue grasper assembly 220 formed in accordance with various principles of the present disclosure is shown in FIGS. 2A-2C. The illustrated tissue grasper assembly 220 has one or more grasper arms 222 shown in FIGS. 2A and 2B in a closed configuration that is at least partially retained within a shaft 216 for delivery to a treatment site TS. Optionally, the grasper arms 222 can be shaped and configured to assume a compact configuration within a lumen 217 of the shaft 216 as can be understood with reference to FIG. 2B. In some embodiments, as shown in FIG. 2A, a distal end 221 of the grasper arm 222 can extend distally outwardly from a distal end 215 of the shaft 216 when the tissue manipulation device 210 advances to the treatment site TS. Optionally, a sharp element, such as a sharp element shown in FIGS. 7A-7C and described in further detail below, can be provided on the distal end 221 of the grasper arm 222 for use in piercing a tissue wall to enable the tissue grasper assembly 220 to pass through the tissue wall (e.g., formed separately and coupled to the distal end, or formed as a portion or extension of the distal end). Alternatively, if the distal end 221 of the grasper arm 222 does not extend distally from the distal end 215 of the shaft 216, the sharp element 150 can be provided or formed on the distal end 215 of the shaft 216. By providing such a sharp element on the tissue grasper assembly 220, a tissue manipulation procedure can be facilitated, such as by reducing the actions and / or required instruments or devices. If no sharp element is provided, an opening through the tissue wall through which the tissue grasper assembly 220 passes can be pre-formed within the tissue wall (e.g., by a separate cutting instrument) prior to insertion of the tissue grasper assembly 220 through the opening.

[0037] The grasping arms 222 of the tissue grasper assembly 220 of FIGS. 2A-2C are operable, extendable, or expandable (such terms are used interchangeably herein without intending to be limiting) from the closed configuration of FIG. 2A to an open configuration as shown in FIG. 2C in which the grasping arms 222 extend or expand outwardly from the shaft 216 / tissue grasper assembly 220 (e.g., radially outwardly with respect to the longitudinal axis L of the shaft 216 or tissue grasper assembly 220, or otherwise laterally). According to one aspect of the present disclosure, the grasping arms 222 are elastically biased to expand or otherwise extend (e.g., extend away from the shaft 216) into an open configuration to engage tissue to be manipulated. In some embodiments, such as the embodiments of FIGS. 2A-2C, the grasping arms 222 are formed of a shape memory material (e.g., stainless steel or a memory shape alloy such as nitinol), and the grasping arms 222 are shaped and configured to be biased toward an open configuration that extends away from the longitudinal axis L of the shaft 216 or tissue grasper assembly 220. When the grasping arms 222 are in a retracted configuration within the shaft 216, the shaft 216 holds the grasping arms 222 in the closed configuration against the natural bias of the grasping arms 222. In some embodiments, the grasping arms 222 include knuckles or other bending or turning features 227 that are shaped, configured, and arranged to hold the grasping arms 222 in a compact configuration within the shaft 216, such as by pressing against the inner side of the shaft 216 to bias the grasping arms 222 into a compact closed configuration within the shaft 216. In some embodiments, the grasping arms 222 cross each other when in the closed configuration and pass over each other to expand or extend into the open configuration, as can be understood with reference to FIGS. 2D and 2E. When the grasping arms 222 are extended distally from the shaft 216, the grasping arms 222 can expand or extend into the open configuration shown in FIG. 2C.

[0038] In one embodiment, the grasping arm 222 is operable by actuating a tissue manipulation device controller 230. The tissue manipulation device controller 230 is coupled to the grasping arm 222 and extends proximally to a location such as the proximal end 113 of the tissue manipulation device 110 and / or the proximal end 103 of the tissue manipulation system 100 as shown in FIG. 1 for a user to access to actuate the tissue manipulation device controller 230 to operate the grasping arm 222 to move as desired (e.g., relative to the shaft 216) between a closed configuration and an open configuration. The tissue manipulation device controller 230 can be coupled to the grasping arm 222 by a controller coupler 240 known or publicly known in the art that can transmit control of a desired motion or movement from the tissue manipulation device controller 230 to the grasping arm 222. The controller coupler 240 preferably holds the proximal end 223 of the grasping arm 222 in a predetermined position while allowing flexion or other motion of the grasping arm 222 (e.g., radially outward motion or expansion). The controller coupler 240 can seat inside a window, notch, or groove inside the shaft 216 to restrain or lock the grasping arm 222 in a desired configuration. An additional collar or stop can be provided on the proximal end 213 of the shaft 216 to create a rigid stop for the controller coupler 240. Further or alternatively, frictional forces or a specific geometric arrangement (interengagement) between the grasping arm 222 and the controller coupler 240 and / or the shaft 216 can provide the desired restraint of the system to hold the grasping arm 222 in a desired location or configuration. Other configurations, other elements such as bayonet locks or barbs are also within the scope of the present disclosure.

[0039] In some embodiments, the tissue manipulation device controller 230 may include a controller element 232 in the form of a wire or other element or structure known or otherwise publicly known in the art that is capable of moving the grasper arm 222 relative to the shaft 216. The controller element 232 may extend to or be coupled with an additional controller element at the proximal end 103 of the tissue manipulation system 100 for operation or control by a user, such as via the control handle 104 at the proximal end 103 of the tissue manipulation system 100. The controller element 232 is shown as being coupled or otherwise engaged with the controller coupler 240. Movement of the controller element 232 (e.g., distal or proximal translational movement of the controller element 232) is transmitted to the tissue grasper assembly 220 to operate the grasper arm 222 between a closed configuration and an open configuration. Other configurations of the tissue manipulation device controller and the controller coupler are also within the scope and spirit of the present disclosure, and it will be understood that the operation and movement of the grasper arm are not limited by a particular configuration of the controller or the controller coupler.

[0040] In the open configuration, the grasping arm 222 preferably presents a grasping surface 225 with a sufficient surface area that is shaped and configured to engage the tissue to enable the manipulation of the tissue by the movement of the grasping arm 222. In some embodiments, as shown in FIG. 2C, at least one free end 221 of the grasping arm 222 (as used herein, the "free end" of an element is the terminal end beyond which such an element does not extend) is provided with a tissue grasping feature 260 configured to facilitate the grasping or engagement of the tissue, such as barbs, hooks, or jaws or other tissue engagement protrusions. The tissue grasping feature 260 is configured to enhance the grasping of the tissue, whereby the grasping arm 222 is not inadvertently moved relative to the tissue wall that is being held in place by the tissue grasping assembly 220 that is left in a predetermined position for functions such as (as will be described in more detail below) holding together tissues that are adhesively compressed to different organs or lumens, or holding together tissues surrounding a defect to repair the defect. For example, the tissue grasping feature 260 can hold the grasping arm 222 against lateral displacement relative to the engaged tissue. In the embodiment shown in FIG. 2C, the tissue grasping feature 260 is in the form of a curved jaw having a distal-facing tip to improve grasping. However, the configuration of the illustrated tissue grasping feature 260 can be replaced by other configurations, locations, etc., including but not limited to the other configurations and locations disclosed herein. Referring to FIGS. 2A and 2C, the grasping arm 222 can be curved, whereby in the closed configuration, the grasping arm 222 is arranged with the convex curved sides or surfaces facing each other, presenting a convex (e.g., non-traumatic) surface at the distal end 221 of the tissue grasping assembly 120. When operating to the open configuration, the grasping arm 222 moves away from the longitudinal axis LA by intersecting each other and presents the convex curved side in the distal direction, such that the concave curved side faces the treatment site TS with the tissue grasping feature 260 positioned to engage the tissue at the treatment site TS.

[0041] An alternative embodiment of the tissue grasper assembly 320 having a grasper arm 322 that includes one or more tissue grasping functional portions 360 is shown in FIGS. 3A and 3B. As can be appreciated, the illustrated tissue grasping functional portion 360 is at the corresponding distal end 321 of the corresponding grasper arm 322 and can be wider than the portion of the corresponding grasper arm 322 in which the tissue grasping functional portion 360 extends and that extends distally. In such a configuration, the tissue grasping functional portion 360 is configured and arranged to engage, contact, or grasp the tissue of the treatment site TS when the tissue manipulation device 310 is moved proximally with the grasper arm 322 in the open configuration shown in FIG. 3B, and has a proximally directed tissue engagement end 363 (which is blunt or sharp but not sharp enough to pierce or cut the tissue). The tissue engagement end 363 can be configured to facilitate hooking onto the tissue of the treatment site TS or otherwise engaging the tissue. Further proximal movement of the tissue manipulation device 310 moves or manipulates the engaged tissue proximally with the tissue manipulation device 310. In some embodiments, as illustrated, the tissue grasping functional portion 360 can include a sharp element 350, such as a sharp region (or a sharp element coupled to the distal end) of the distal end 361 of the tissue grasping functional portion 360, for accessing by piercing the tissue wall, etc., as described above with respect to other embodiments of sharp elements on the distal end of the grasper arm or shaft.

[0042] In some embodiments, the tissue grasping functional portion is configured such that when the tissue grasper assembly and the tissue manipulation device are actuated, they contact or engage the tissue to move the tissue, but are not blocked or restricted in other ways from being displaced (e.g., moving laterally) relative to the engaged tissue. Such a tissue grasping functional portion can be said to contact or abut the engaged tissue in a manner that enables it to grasp the tissue without hooking into the tissue or otherwise engaging the tissue, by the tissue grasping functional portion alone (e.g., similar to a hook or barb that can grasp the tissue by hooking into the tissue, independently of further movement or function of the grasper arm). In some examples of such embodiments, the tissue grasping functional portion is in the form of a blunt or smooth surface, such as a surface that does not hook into the tissue. In some further examples of such embodiments, the grasper arm has a grasper surface with an increased surface area compared to the surface area of the region or zone of the grasper arm distal to such a tissue grasping functional portion and / or independently of other functions or operations of the grasper arm (e.g., by hooking into the tissue) that can grasp the tissue compared to the tissue grasping functional portion.

[0043] Examples of the operation and movement of the tissue manipulation device 110 formed in accordance with the principles of the present disclosure and used in accordance with some aspects of the present disclosure are shown in FIGS. 4A - 4D, FIGS. 5A - 5C, and FIGS. 6A - 6C. The illustrated tissue manipulation device 110 may be similar to the tissue manipulation device 210 of FIGS. 2A - 2E, but it will be understood that the examples of FIGS. 4A - 4D, FIGS. 5A - 5C, and FIGS. 6A - 6C are not limited to a particular configuration of the tissue manipulation device and that other configurations, such as those disclosed herein or in other ways, may alternatively be used.

[0044] As shown in FIG. 4A, the tissue manipulation device 110 shown in the closed configuration has advanced distally, optionally through the proximal body cavity or lumen (not shown) through the distal end of the delivery device (such as the flexible elongate member 102 as shown in FIG. 1 when used), and is shown as approaching the treatment site TS such as the distal tissue wall DTW. The opening that penetrates the distal tissue wall DTW through which the tissue gripper assembly 120 passes can be pre-formed in the tissue wall (by a separate cutting procedure or the like) before inserting the tissue gripper assembly 120 through the tissue wall. Alternatively, if a sharp element is provided on the distal end 101 of the tissue manipulation device 110, the sharp element can be used to create an opening, such as by puncturing the distal tissue wall DTW. In FIG. 4B, the tissue manipulation device 110 is shown penetrating the distal tissue wall DTW (such as an organ wall such as the stomach wall, or a lumen wall distal to the proximal body cavity or lumen) and extending into the distal body cavity or lumen. In FIG. 4C, the tissue gripper assembly 120 is shown operating or having been operated to the open configuration (such as by the operation of the tissue manipulation device controller 130 not shown in this figure). The tissue gripper assembly 120 is then moved proximally to engage the distal tissue wall DTW (such as with the tissue gripper arm 122 having, for example, the tissue gripping feature 160 formed on the tissue gripper surface 125 and / or one or more gripper arms 122). As shown in FIG. 4D, the distal tissue wall DTW can then be manipulated proximally as desired, for example to a desired location, for example towards the proximal tissue wall and optionally in an adherent and crimped state with the proximal tissue wall (for example, the distal lumen can be moved proximally).

[0045] In various embodiments described within the scope of the present disclosure or other modalities within the scope of the present disclosure, and according to one aspect of the present disclosure, when the tissue / organ is manipulated (e.g., retracted) to its desired location, the user can remove the tissue manipulation device 110, or continue the treatment with the tissue manipulation device 110 held in a predetermined position or with the tissue gripper assembly 120 retained (separated from other components of the tissue manipulation device 110 and left in a predetermined position). For example, the tissue gripper assembly 120 can be operated to disengage from the treatment site TS, return to a closed configuration, and be moved proximally out of the body. Then, further treatment can be performed at the treatment site TS. Alternatively, the retained tissue manipulation device 110 can be left in a predetermined position to maintain the tissue at its desired location (e.g., in an adherent and compressed state with another tissue or organ) at the end or for the purpose of the treatment, or can also be used to close a large tissue defect or perforation (e.g., within a single lumen). In some embodiments, the tissue gripper assembly 120 is formed having a collar, or a capsule, or a hypo tube 126 (such terms are substantially interchangeable and the term "capsule" is used herein without intending to limit for convenience) removably mounted on the distal end 115 of the shaft 116, and the gripper arms 122 are coupled to or otherwise mounted within the capsule 126. In some embodiments, the capsule 126 is removable or separable from the shaft 116 to retain the tissue gripper assembly 120 at the treatment site TS (with the gripper arms 122 engaged with the treatment site TS) and to remove the shaft 116 and the remaining elements of the tissue manipulation device 110. It will be understood that references to the shaft or capsule herein can be considered interchangeable and that the "capsule" is not limited to referring to a separate element coupled to the "shaft".

[0046] In one embodiment shown in FIGS. 5A-5C, when the distal tissue wall DTW is moved into an adhesion and crimping state with the proximal tissue wall PTW (such as according to the procedures or methods shown in FIGS. 4A-4D), a locking mechanism 128, such as a collet or other suitable structure, known or publicly known in the art, having elements shaped and configured to engage elements of the tissue gripper assembly 120, can be actuated to hold the tissue gripper assembly 120 in a state where the gripper arm 122 is engaged with the tissue at the treatment site TS in an open configuration or the like, as shown in FIG. 5A. The locking mechanism 128 can engage the capsule 126 (or other components of the tissue gripper assembly 120) to hold the adhered and crimped tissue together, as shown in FIG. 5B. This can be achieved using an outer catheter or an inner push rod or a control wire that serves to hold and actuate the components in any of various known ways. The locking mechanism 128 can include a flange or other region (e.g., an enlarged region) that provides the tissue gripping surface 125. Then, the shaft 116 can be removed from or decoupled from (e.g., removed from or decoupled from the shaft 116) the tissue gripper assembly 120 and pulled proximally from the treatment site TS. Frictional forces, locking tabs, barbs, positive stops, ratchet locks, etc. can be used or applied as known in the art. It will be understood that any of various other locking mechanisms can be used in accordance with the principles of the present disclosure to hold the tissue gripper assembly 120 and the gripper arm 122 in place when the shaft 116 is decoupled from the tissue gripper assembly 120 and the gripper arm 122.

[0047] As can be appreciated and as described above, the tissue manipulation device 110 according to the principles of the present disclosure can be used in a variety of procedures other than pulling together and / or holding the tissue walls of different organs or lumens. For example, as shown in FIGS. 6A-6C, the tissue manipulation device 110 can be used to repair a defect by pulling together the tissue walls on different sides (e.g., both sides) or edges of the defect. As shown in FIG. 6A, the tissue gripper assembly 120 can be advanced to the tissue defect TD, and one of the gripper arms 122 can be engaged with the tissue wall along the side or edge of the tissue defect TD, such as by engaging the gripping functional portion 160 of the gripper arm 122 with the tissue. Next, as shown in FIG. 6B, with the gripper arms 122 in the open configuration, the tissue gripper assembly 120 is operated to cross the defect with the gripped tissue, and another gripper arm 122 is engaged with another region of the tissue wall along the tissue defect TD (such as the tissue wall of the tissue defect site on the opposite side of the already gripped tissue wall area). The gripping functional portion 160 on the gripper arm 122 that is engaged with the initially gripped tissue region can facilitate maintaining the holding of the gripper arm 122 on the initially gripped tissue region. With different regions of the tissue along the tissue defect TD being engaged by different gripper arms 122, the tissue gripper assembly 120 is operated to the closed configuration as shown in FIG. 6C to pull or draw the tissues together. For example, as shown in FIGS. 5A-5C, the locking mechanism 128 can be used to maintain the relative position and gripping between the tissue gripper assembly 120 and the gripped tissue region. By leaving the tissue gripper assembly 120 in the closed configuration at a predetermined position to hold the tissue walls in an adherent and crimped state and reducing the size of the tissue defect TD, it is possible to heal the defect. As can be appreciated, the gripping functional portion 160 can facilitate holding the tissue gripper assembly 120 on the tissue throughout the repair procedure.

[0048] As will be appreciated, various alternative configurations of the tissue grasper assembly 120 that are expandable from a closed configuration to an open configuration are also within the scope of the present disclosure, as will be described next. For example, various tissue grasper assemblies within the scope of the present disclosure, such as those shown in FIGS. 7A-7C, FIGS. 8A-8C, FIGS. 9A-9C, and FIGS. 10A-10C, are formed with grasper arms that are elastic and biased to extend into or be held in an open configuration. Other tissue grasper assemblies, such as those shown in FIGS. 11A, 11B, 12A, and 12B, are expandable from a closed configuration to an open configuration.

[0049] As briefly described above, sharp elements, such as those shown in the example of the tissue grasper assembly 420 shown in FIGS. 7A-7C, can be provided at the distal end of a tissue manipulation device formed in accordance with various principles of the present disclosure. The sharp element 450 can be formed at the distal end 421 of the grasper arm 422 and extend distally from the distal end 421. The sharp element 450 can strike the tissue wall of the treatment site TS and puncture the tissue wall, enabling the remainder of the tissue grasper assembly 420 to extend through the puncture. The grasper arm 422 of the tissue grasper assembly 420 of FIGS. 7A-7C, and other functional portions of the tissue grasper assembly 420, can be substantially similar in other respects to the functional portions of the tissue grasper assembly 220 shown in FIGS. 2A-2C.

[0050] Different configurations of the resiliently biased gripper arms are shown in FIGS. 8A-8C. The gripper arms 522 of the tissue gripper assembly 520 of FIGS. 8A-8C are housed inside the shaft 516 (or a removable capsule 526 coupled to the shaft, such as the removable capsule described above) and biased into a storage configuration that extends along the longitudinal axis LA of the shaft 516 or capsule 526 and / or the tissue gripper assembly 520. They can be configured as two or more (such as three or four or more) curved bars. When the tissue operating device controller (such as that shown in the embodiments of FIGS. 2A-2C or FIGS. 7A-7C) is actuated, the gripper arms 522 can be advanced distally so as to extend distally from the shaft 516 or capsule 526. The gripper arms 522 are no longer housed inside the shaft 516 or capsule 526 and are not constrained by the shaft 516 or capsule 526, and are free to expand or extend outwardly (e.g., radially outwardly or laterally) with respect to the longitudinal axis LA, as shown in FIG. 8C. At least two of the gripper arms 522, when in the open configuration, extend in different directions and present a gripper surface 525 having a sufficient surface area of a configuration and shape to engage the tissue to be operated on. As described above with reference to the foregoing embodiments, a tissue gripping feature 560, such as barbs, hooks, jaws, or other tissue engaging protrusions, can be provided to facilitate gripping of the tissue.

[0051] Formed in accordance with the principles of the present disclosure, in another embodiment shown in FIGS. 9A-9C, the tissue grasper assembly 620 is formed having a substantially linear grasper arm 622, such as in the form of an elastic elongate element or bar. When the tissue manipulation device controller 630 (such as any of the tissue manipulation device controllers described herein) is operated to advance the tissue grasper assembly 620 distally, the grasper arm 622 extends from the distal end 615 of the shaft 616 (or a removable capsule 626 coupled to the shaft, such as the capsule described above). As the grasper arm 622 exits the distal end 615 of the shaft 616 or capsule 626, the grasper arm 622 strikes a direction-changing feature 627 (such as a wall or other obstacle or obstruction) at the distal end 615 of the shaft 616 or capsule 626 and bends or deflects to exit laterally with respect to the longitudinal axis LA of the tissue grasper assembly 620 through a corresponding exit opening 629, and presents a grasper surface 625 for engaging the tissue wall proximally, for example, by forming a "T" shape when open, as shown in FIGS. 9B and 9C. To facilitate grasping of the tissue, a tissue grasping feature 660, such as a hook, barb, or other tissue engaging protrusion, can be provided or formed on one or more of the free ends 621 of the grasper arm 622.

[0052] Referring to the embodiments shown in FIGS. 10A-10C and the like, it will be understood that the tissue grasper assembly can be formed to have a single grasper arm similar to the grasper arms of the embodiments of FIGS. 9A-9C. More specifically, referring to the tissue grasper assembly 720 shown in FIGS. 10A-10C, a single elongate grasper arm 722 can be held or housed within a shaft 716 (or a removable capsule 726 coupled to the shaft such as the above-described capsule) and biased into a storage configuration extending along the longitudinal axis LA of the shaft 716 or capsule 726 and / or the tissue grasper assembly 720. Similar to the tissue grasper assembly 620 of FIGS. 9A-9C, when a tissue manipulation device controller 730 (such as any of the tissue manipulation device controllers described herein) is operated to advance the tissue grasper assembly 720 distally, the grasper arm 722 extends from the distal end 715 of the shaft 716 (or a removable capsule 726 coupled to the shaft such as the above-described capsule). When the grasper arm 722 exits from the distal end 715 of the shaft 716 or capsule 726, the grasper arm 722 strikes a direction-changing feature 727 (such as a wall or other obstacle or obstruction) at the distal end 715 of the shaft 716 or capsule 726 and bends or deflects to exit laterally with respect to the longitudinal axis LA of the tissue grasper assembly 720 as shown in FIG. 10C. In contrast to the direction-changing feature 627 of the tissue grasper assembly 620 of FIGS. 9A-9C, the direction-changing feature 727 of the tissue grasper assembly 720 of FIGS. 10A-10C preferably has a single exit opening 729 for directing the grasper arm 722 in a desired direction. To facilitate grasping of tissue, a tissue grasping feature 760, such as a hook, barb, or other tissue-engaging protrusion, can be provided or formed along the grasper arm 722. Two or more tissue grasping features 760 are shown, for example, one at the free end 721 of the grasper arm 722 and an additional tissue grasping feature 760 extending along the grasper surface 725 of the grasper arm 722. However, it will be understood that the tissue grasping feature 760 can also be in other configurations as described herein.

[0053] The gripper arms of the tissue gripper assembly of the tissue manipulation device formed in accordance with various principles of the present disclosure can be elastically biased to expand away from the shaft of the tissue manipulation device in a certain direction in addition to radially outward. For example, as shown in the embodiments of FIGS. 11A and 11B, the tissue manipulation device 810 has a tissue gripper assembly 820 having a helical gripper arm 822 that is held in a substantially compact or elongated / linear configuration within the shaft 816 of the tissue manipulation device 810 (or a removable capsule 826 coupled to the shaft, such as the capsule described above, or the delivery device of the tissue manipulation system 100) in a closed configuration as shown in FIG. 11A. The gripper arm 822 can be configured to operate between a closed configuration and an open configuration, such as when the tissue manipulation device controller is activated, as described for other embodiments not shown but described herein. The gripper arm 822 can be coupled to the tissue gripper assembly 820 in any manner known or known in the art, for example, via a controller coupler as described herein with reference to other embodiments. In one embodiment, the distal movement of the gripper arm 822 extends the distal end 821 from the distal end 815 of the shaft 816 or capsule 826, for example, through the outlet opening 829. When no longer constrained by the shaft 818, the gripper arm 822 can expand into a helical shape that is configured and dimensioned to engage the tissue (having an outer diameter larger than the outer diameter of the shaft 816 or capsule 826 and having sufficient volume), whereby the movement or operation of the tissue manipulation device 810 to move or operate the tissue gripper assembly 820 causes the desired operation of the engaged tissue. For example, in one embodiment, the helical configuration includes more than two turns of the gripper arm 322, and these helical turns form a gripper surface 825 that includes multiple turns of the helix by being substantially concentric and in the same plane.Other configurations that extend sufficiently radially outward to engage tissue and have sufficient strength to pull on the tissue when the tissue grasper assembly 820 is moved proximally are also within the scope of the present disclosure will be appreciated.

[0054] The grasper arms of the tissue grasper assembly of a tissue manipulation device formed in accordance with various principles of the present disclosure can be made expandable in other ways, such as to expand away from the shaft of the tissue manipulation device. For example, as shown in the embodiments of FIGS. 12A and 12B, the tissue manipulation device 910 can have a tissue grasper assembly 920 having grasper arms 922 in the form of an element expandable radially outward, such as a balloon. The grasper arms 922 are held in a substantially compact configuration within the shaft 916 of the tissue manipulation device 910 in a closed configuration as shown in FIG. 12A. The grasper arms can be extended distally from the shaft 916, such as by inflation, in accordance with various known or publicly known methods used to expand such grasper arms. The grasper arms 922 can be moved to engage tissue, whereby movement or operation of the tissue manipulation device 910 to move or operate the tissue grasper assembly 920 causes the grasper arms 922 to move or operate the engaged tissue. A sharp element 950, such as a sharp tip or needle, can be provided at the distal end 915 of the shaft 916, whereby the tissue grasper assembly 920 can pierce the tissue wall through which the tissue grasper assembly 920 extends.

[0055] According to one aspect of the present disclosure, the resiliently biased gripper arm can be in the form of a wire, such as a wire resiliently biased into a tissue hook configuration. Generally speaking, referring to FIGS. 13A and 13B, the tissue manipulation device 1110 can have a tissue gripper assembly 1120 having a gripper arm 1122 in the form of a wire having a distal end 1121 that is bent into the form of a barb or hook (such terms are used interchangeably herein without intending to be limiting). The tissue gripper assembly 1120 can be advanced distally (or can also puncture the tissue) through an opening pre-formed in the tissue at the treatment site TS, and the hook-shaped distal end 1121 of the gripper arm 1122 is moved to engage the distal surface of the tissue. The bent distal end 1121 of the gripper arm 1122 can be made of a shape memory alloy (such as nitinol) to facilitate the distal end 1121 passing through the working channel of the shaft 1116 or other delivery device in a straight configuration before being reformed into a hook when exiting the distal end of the shaft 1116 or the delivery device, such as when reaching the treatment site TS. In some embodiments, as described herein, the tissue gripper assembly 1120 extends through the proximal tissue wall PTW and the distal tissue wall DTW, and the tissue gripper assembly 1120 is moved proximally to draw those walls together, such as into an adherent crimped state. The distal end 1121 of the gripper arm 1122 can be sharp enough to penetrate the proximal tissue wall PTW. When the tissue is positioned as desired, for example via a controller (such as a controller as disclosed herein with reference to other embodiments, or another suitable controller known or known in the art), a locking mechanism 1128 can be placed to hold the gripper arm 1122 in a predetermined position relative to the tissue. In one embodiment, the locking mechanism 1128 includes a retention mechanism 1170, such as a retention cap or retention collar or retention capsule, having a gripper surface 1175 configured to engage the proximal surface of the proximal tissue wall PTW and hold the proximal tissue wall PTW and the distal tissue wall DTW in a predetermined position together with the gripper arm 1122.In one embodiment, the retention mechanism 1170 can be configured to hold the distal end 1121 of the grasper arm 1122 in a predetermined position. The retention mechanism 1170 can also wrap, shield, or cover the optionally sharp tip or distal end 1121 of the grasper arm 1122 to protect the surrounding tissue against the possibility of trauma. The proximal region of the wire forming the grasper arm 1122 can be severed by, but not limited to, the tension ball method (e.g., a ball-in-cup configuration that separates when the wire is pulled proximally away from the treatment site TS), breaking of the wire along a pre-weakened region, release of crimping of a capsule, or deformation / breaking of a tab, or other structures that break upon further tensile loading of the wire.

[0056] In one embodiment, as shown in FIG. 14, a tissue manipulation device 1210 similar to the tissue manipulation device 1110 shown in FIGS. 13A and 13B can utilize a delivery device 1202 having two or more lumens, such as a double lumen endoscope. A grasper arm 1222, such as in the form of a wire having a pre-formed barb or hook at its distal end, can be advanced distally through the working channel of the first lumen. The hook can be shaped so that the distal end 1221 of the grasper arm 1222 (e.g., the barb tip) can be aligned with another working channel of the delivery device 1202. When the tissue is positioned as desired, for example via a controller (such as a controller as disclosed herein with reference to other embodiments, or another suitable controller known or publicly known in the art), a locking mechanism 1228 can be deployed to hold the grasper arm 1222 in place relative to the tissue, for example by friction fitting. In one embodiment, the locking mechanism 1228 includes a retention mechanism 1270 in the form of a collar or disk (such terms are used for simplicity and are not intended to be limiting, and are used interchangeably herein, and such elements are not intended to be limited to a circular cross-sectional shape or other shape) having a grasper surface 1275 configured to engage the proximal surface of the tissue at the treatment site and hold the tissue at the treatment site in the desired position together with the grasper arm 1222. The retention mechanism 1270 can serve as a deployment mechanism and / or as a stop for holding the tissue in place after deployment.

[0057] The retention mechanism 1228 may further include a retention collar 1272, such as a protective cap. In some embodiments, the retention collar 1272 is retained through or otherwise positioned in another working channel of the delivery device 1202 (e.g., a working channel in which the distal end 1221 of the gripper arm 1222 is aligned when advancing out of the first working channel of the delivery device 1202). The retention collar 1272 can be sized and shaped to receive the optionally sharp tip of the distal end 1221 of the gripper arm 1222, such as after the tip has penetrated tissue at a desired location. The retention collar 1272 can serve to wrap, shield, or cover the sharp tip (if provided) of the distal end 1221 of the gripper arm 1222 to stop or hold tissue and / or to protect the surrounding tissue against the possibility of trauma. An example of one embodiment of a tubular retention collar 1272 is shown in cross-section in FIG. 15, showing a through-hole 1273 within the retention collar 1272 through which the distal end 1221 of the gripper arm 1222 can pass. The through-hole 1273 can be formed within a retaining wall 1274 that extends radially inwards from the inner wall of the collar. The distal end 1221 of the gripper arm 1222 can be elastically biased outwards and pushed through the retaining wall 1274. The retaining wall 1274 can be provided with a retaining surface 1275 on the proximal side of the retaining wall 1274, such that when the distal end 1221 of the gripper arm 1222 passes through the through-hole 1273, the distal end 1221 expands into a relaxed (wider in the transverse direction relative to the portion of the wire extending proximally beyond the diameter of the through-hole 1273) expanded configuration and is prevented from retreating distally through the through-hole 1273, thereby being locked in place relative to the retention collar 1272 and the treatment site. As can be appreciated, multiple retention mechanisms 1270 and / or multiple retention collars 1272 can be provided on the tissue gripper assembly 1220 and coupled via a light press fit or similar mechanism, etc.Also, it will be understood that the tissue manipulation device 1210, as shown in FIG. 14, can be supplied with one or more gripper arms 1222, one or more of which include a metal barb device or the like.

[0058] Referring to FIGS. 16 and 17, the tissue manipulation device 1210 of FIG. 14 can be used to close a defect or to pull and hold two separate lumens together. For example, as shown in FIG. 16, tissue on opposite sides of the tissue defect TD can be drawn together by the gripper arms 1222, and a holding mechanism 1270 can be held or locked on one side of the tissue defect TD and a retention collar 1272 can be held or locked on the other side of the tissue defect TD, thereby holding the tissue gripper assembly 1220 in a predetermined position. As shown in FIG. 17, the gripper arms 1222 can be looped through the tissue so as to be held together in an adhering and crimping state at the treatment site TS. The tissue gripper assembly 1220 holds the holding mechanism 1270 at the entry site (the site where the tissue gripper assembly 1220 first enters the treatment site TS, and where the proximal end of the tissue gripper assembly 1220 is located when the tissue gripper assembly 1220 is placed in the treatment site TS), and also holds the retention collar 1272 at the exit site (the site where the distal end 1201 of the tissue gripper assembly 1220 exits the treatment site TS, and where the distal end of the tissue gripper assembly 1220 is located when the tissue gripper assembly 1220 is placed in the treatment site TS), thereby being held in a predetermined position.

[0059] In some embodiments, a grasper arm in the form of an elastically biased wire can be used in a tissue manipulation device suitable for closing large defects, such as in the example of the tissue manipulation device 1310 shown in FIG. 18. Similar to the tissue manipulation device 1210 shown in FIG. 14, the tissue manipulation device 1310 includes a grasper arm 1322, such as in the form of a wire having a pre-formed barb or hook at its distal end. The hook can be shaped such that the distal end 1321 of the grasper arm 1322 (e.g., the barb tip) faces in the proximal direction. The grasper arm 1322 can extend through a lumen 1317 defined through a shaft 1316. The shaft 1316 can be advanced distally, for example, through the working channel of a delivery device 1302 of a tissue manipulation system 1300, to advance the tissue manipulation device 1310 to the treatment site. Alternatively, the shaft 1316 can also be delivered by over-the-scope delivery, including being parallel to (optionally not fully surrounding) a scope.

[0060] The tissue gripper assembly 1320 of the tissue manipulation device 1310 of FIG. 18 may include one or more tissue holding mechanisms 1370, which can be supported by a shaft 1316 and can be associated with the gripper arm 1322, such as by the gripper arm 1322 passing through a portion of the tissue holding mechanism 1370. The tissue holding mechanism 1370 is configured to engage the proximal surface of the tissue at the treatment site and, together with the gripper arm 1322, hold the tissue at the treatment site in a desired position, and has a gripper surface 1325 and can be in the form of a collar or disk (such terms are used for simplicity and are not intended to be limiting and are used interchangeably herein, and such elements are not intended to be limited to a circular cross-sectional shape or other shape). The gripper arm 1322 and the holding mechanism 1370 can be movable relative to each other, for example, independently of each other, such that various elements can engage the tissue at the treatment site to manipulate the tissue and perform a desired treatment or other treatment on the tissue. In one embodiment, the shaft 1316 has an inner shaft 1316i that supports a distal holding mechanism 1370d and an outer shaft 1316o that supports a proximal holding mechanism 1370p, thereby enabling relative movement between the holding mechanisms 1370 for gripping or manipulating the tissue and / or holding the tissue between those holding mechanisms.

[0061] The retention collar 1372 can be movably supported by the shaft 1316 or separately retained to hold the tissue grasper assembly 1320, which includes the grasper arms 1322 and one or more retention mechanisms 1370, in a predetermined position according to the requirements at the treatment site. Similar to the retention collar 1272 shown in FIG. 15, the grasper arms 1322 of the tissue manipulation device 1310's tissue grasper assembly 1320 in FIG. 18 can hold (e.g., restrain or lock) with respect to the retention collar 1372, such as by engaging a retention wall 1374 that extends radially inwards from the inner wall of the retention collar 1372. More specifically, the distal end 1321 of the grasper arm 1322 can be elastically biased outwards and pushed through a through-hole 1373 in the retention wall 1374. The retention wall 1374 can be provided with a retention surface 1375 on its proximal side, so that when the distal end 1321 of the grasper arm 1322 passes through the through-hole 1373, the distal end 1321 expands into an expanded configuration (wider laterally than the portion of the wire extending proximally relative to the diameter of the through-hole 1373) and is prevented from retreating through the through-hole 1373, thereby being locked in a predetermined position with respect to the retention collar 1372 and the treatment site. Two or more retention collars 1372 can be provided, and these two or more retention collars 1372 are coupled by means such as a light press fit or a similar mechanism. If necessary, the distal retention collar 1372 can be supported by the shaft 1316, and the more proximal retention collar 1372 can be separately retained through another working channel of the delivery device 1302 or the like.

[0062] Using the tissue manipulation device 1310 of FIG. 18, a defect can be closed, for example, as shown in FIGS. 19A-19E. For example, as shown in FIG. 19A, the distal retention mechanism 1370d can be positioned distal to the distal tissue region parallel to the tissue defect TD and engaged with the distal tissue. The proximal retention mechanism 1370p can be positioned proximal to the engaged distal tissue. By maintaining the distal retention mechanism 1370d and the proximal retention mechanism 1370p in proximity (for example, by controlling the relative positions of the inner shaft 1318i and the outer shaft 1316o that support the distal retention mechanism 1370d and the proximal retention mechanism 1370p respectively), as shown in FIG. 19B, the retention mechanisms 1370d, 1370p can be drawn together and the distal retention mechanism 1370d can be moved proximally toward the proximal retention mechanism 1370p so as to grip the initially engaged distal tissue therebetween. The distal end 1301 of the gripper arm 1322 (facing the proximal direction) can be provided with a sharp tip for penetrating the clamped tissue and passing through the tissue. The gripped distal tissue can be manipulated, pulled, or drawn proximally to the proximal tissue on the other side of the tissue defect TD, as shown in FIG. 19C. By moving the proximal retention mechanism 1370p proximally away from the distal retention mechanism 1370, as also shown in FIG. 19C, the proximal tissue on the other side of the tissue defect TD is positioned between the tissue retention mechanisms 1370d, 1370p and gripped therebetween, making it possible to hold the tissue regions on different sides of the defect together, for example, to repair or close the defect. The distal end 1301 of the gripper arm 1322 can be further moved proximally such that its sharp tip penetrates the proximal tissue. Then, by moving the retention collar 1372 to a predetermined position and holding the distal end 1301 of the gripper arm 1322 in that position, the gripped tissue regions can be held together to repair the defect. As shown in FIG. 19E, the retention collar 1372 can be configured to replace the proximal retention mechanism 1370p (which can be removed and retrieved) at a position proximal to the defect to be repaired.As can be appreciated, the retention collar 1372 can wrap around, or shield, or cover the sharp tip of the grasper arm 1322 within the retention collar to protect the surrounding tissue against the possibility of trauma. The distal retention mechanism 1370d is implanted with the tissue grasper assembly 1320 to hold the tissue in a predetermined position. The proximal retention mechanism 1370p can be implanted with the tissue grasper assembly 1320 or can remain attached to the shaft 1316. The grasper arm 1322 can be broken off or otherwise detached from the proximal portion of the tissue manipulation device 1310 for implantation. For example, the grasper arm 1322 can be held within the inner shaft 1316i by a protrusion or a locking tab, or by friction fit, and this inner shaft can be detached from the outer shaft 1316o during implantation and fastened together with the components of the implanted tissue grasper assembly 1320. The portion of the barb at the distal end 1301 of the grasper arm 1322 that is implanted can include additional nodes or collars or further barbs that engage the retention collar 1372 to help keep the defect in a closed state after implantation. FIGS. 19A-19E can be understood to illustrate the use of the tissue manipulation device 1310 for closing a defect, such as within the lumen of the gastrointestinal (GI) tract, although the illustrated tissue manipulation device 1310 can also or alternatively be used to pull the intestine towards the stomach for other GI procedures such as a gastric bypass procedure. Some tissue grasper assemblies 1320 can be implanted around a newly created opening that has the potential to form a permanent fistula.

[0063] Considering the above, the tissue manipulation device 1310 of FIGS. 18 and 19A-19E can be made small enough to fit within the working channel of a delivery device such as an endoscope, or can be a hybrid device characterized by an over-scope device, or an over-scope of one or both of the retention mechanisms 1370d, 1370p, a through-scope of the retention collar 1372, and either an over-scope or a through-scope of the gripper arm 1322. It will be appreciated that in some embodiments, such as in the case of a hybrid device, the proximal retention mechanism 1370p can be replaced with an endoscope cap, such as those commonly used for endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) procedures. The hybrid device may also enable the use of multiple gripper arms 1322 in conjunction with a pair of retention mechanisms 1370.

[0064] According to various principles of the present disclosure, the principles of an elastically biased gripper arm, as broadly described herein, can be utilized to form additional tissue manipulation devices. One embodiment of a tissue manipulation device 1410 configured to pull a tissue wall into an adhered and crimped state is shown in FIGS. 20A-20C. The tissue manipulation device 1410 can be configured to hold a tissue wall (e.g., a portion of the intestine that is secured to the stomach for a gastric bypass procedure, etc.) together and leave it in a predetermined position and can therefore be characterized as a rivet. As shown, the tissue manipulation device 1410 has one or more gripper arms 1422, such as in the form of a curved bar, and has a collar or capsule 1426 around a central portion of the tissue manipulation device 1410 between a proximal gripper arm 1422p and a distal gripper arm 1422. The tissue gripper assembly 1420 (capsule 1426 and gripper arm 1422) can be loaded into another sleeve, such as a delivery device of the tissue manipulation system 100, e.g., a flexible elongate member 102, or a shaft 1416 of the tissue manipulation device 1410, as shown in FIG. 20A. The flexible elongate member 102 or shaft 1416 biases the gripper arms 1422 into a closed and extended configuration that is substantially flat and extends along the longitudinal axis LA of the capsule 1426 or the tissue gripper assembly 1420 or the shaft 1416, allowing this device to be passed through the working channel of the shaft 1416 and / or the flexible elongate member 102 of the tissue manipulation system 100. Friction from the gripper arms 1422 that are elastically biased (usually biased to extend into a radially outwardly extending open configuration as shown in FIG. 20C) against the inside of the shaft 1416 may be sufficient to hold the tissue gripper assembly 1420 in place inside the shaft 1416, but if not, an internal connection to the gripper arms 1422 and / or the capsule 1426 will be required. Any connection or element known or otherwise available in the art for enabling detachment for optional retention, such as a detachable push rod used in a hemostatic clip to enable attachment and detachment, can be used.

[0065] As shown in FIG. 20A, the distal end 1415 of the shaft 1416 is positioned beyond the distal tissue wall DTW and the distal end 1411 of the tissue manipulation device 1410 is passed through an opening (e.g., a pre-formed opening) in the tissue wall that will be drawn together until the distal end of the tissue grasper assembly 1420 is disposed inside the distal lumen. In the illustrated embodiment, the distal end 1415 of the shaft 1416 is passed through an opening in the target intestinal wall. As shown in FIG. 20B, the capsule 1426 is partially extruded distally from the distal end 1415 of the sleeve 1416 together with the distal grasper arm 1422d, enabling the distal grasper arm 1422d to expand radially outward. At this point, the distal tissue wall DTW (e.g., the intestine) can be retracted into an opening created in the proximal tissue wall PTW (e.g., the gastric wall). Next, by further retracting the shaft 1416 proximally, the proximal grasper arm 1422p is released from the shaft 1416 and can expand radially outward to the open configuration shown in FIG. 20C. If an internal connection to the tissue grasper assembly 1420 was required, the internal connection can be severed at this point and the tissue grasper assembly 1420 can be fully deployed to clamp both the distal tissue wall DTW and the proximal tissue wall PTW together.

[0066] In view of the above description, it will be appreciated that the devices, systems, and methods disclosed herein can be used to form one or more anastomoses and can be used in conjunction with basic endoscopic tools, catheters, laparoscopes, general surgical tools, etc. For example, a catheter-based stent delivery device can be used in conjunction with an endoscope to form one anastomosis, for example, between two portions of the intestine. It is also possible to form an anastomosis between the fundic pouch and a portion of the intestine such as the jejunum using an endoscope-based device. Combinations of laparoscope-based devices and catheter devices as described herein can also be used to form a single anastomosis.

[0067] The foregoing discussion has broad applicability and is presented for purposes of illustration and explanation and is not intended to limit the disclosure to one or more forms disclosed herein. It will be understood that various additions, modifications, and substitutions can 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 can be embodied in other forms, structures, arrangements, ratios, and using other elements, materials, and components without departing from its concepts, spirit, scope, or characteristics. For example, various features of the disclosure are grouped together as one or more aspects, embodiments, or configurations for purposes of streamlining the disclosure. However, it should be understood that the various features of a particular aspect, embodiment, or configuration of the disclosure can be combined as alternative aspects, embodiments, or configurations. The disclosure is presented from the perspective of embodiments, but it should be understood that the various distinct features of the subject matter need not all be present to achieve at least some of the desired characteristics and / or advantages of the subject matter or such individual features. Those skilled in the art will understand that the disclosure can be used with many modifications, or structures, arrangements, ratios, materials, components, and other modifications used in the practice of the disclosure, specifically adapted to particular environments and operating requirements without departing from the principles, spirit, or scope of the disclosure. For example, an element shown as being integrally formed can be composed of a plurality of parts, or an element shown as a plurality of parts can be integrally formed, the operation of an element can be reversed or otherwise changed, and the size or dimensions of an element can be changed. Similarly, although operations, actions, or procedures are described in a particular order, this should not be understood to mean that such a particular order is required to achieve a desirable result, or that all operations, actions, or procedures should be performed. Further, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve a desirable result.Therefore, embodiments of the present disclosure should be considered illustrative in all respects and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or to the specific embodiments or configurations described or illustrated herein. In view of the foregoing, the individual features of any embodiment can be used separately or in combination with the features of that embodiment or any other embodiment and can be claimed, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0068] In the foregoing description and the following claims, the following points will be understood. The phrases "at least one", "one or more", and "and / or" are open-ended expressions that are used as both conjunctive and disjunctive when used in this specification. The terms "a", "an", "the", "first", "second", etc. do not exclude a plurality. For example, the term "a" or "an" entity, when used in this specification, refers to one or more of that entity. Therefore, the terms "a" (or "an"), "one or more", and "at least one" can be used interchangeably in this specification. All references to directions (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used only for identification purposes to assist the reader's understanding of the present disclosure and / or to help distinguish the areas of associated elements from each other, and do not particularly limit the associated elements with respect to the position, orientation, or use of the present disclosure. References to connections (e.g., attached, coupled, connected, and joined) should be construed broadly and may include intermediate members between sets of elements and relative movement between elements, unless otherwise indicated. Therefore, references to connections do not necessarily imply that two elements are directly connected and in a fixed relationship to each other. References to identification (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority and are used to distinguish one feature from another. The following claims are hereby incorporated by reference into this "Detailed Description of the Invention", and each claim stands on its own as a separate embodiment of the present disclosure. The reference numerals in the claims are provided merely as examples of clarification and should in no way be construed as limiting the claims.

[0069] The following claims are hereby incorporated by reference into this "Mode for Carrying Out the Invention", and each claim is independent as a separate embodiment of the present disclosure. In the claims, the terms "comprises" and "comprising" do not exclude the presence of other elements or steps. Further, although individual features may be included in different claims, these features can, in some cases, be advantageously combined, and the inclusion in different claims does not imply that the combination of features is not possible and / or not advantageous. Further, references to the singular do not exclude the plural. Terms such as "a", "an", "the", "first", "second", etc. do not exclude the plural. The reference signs in the claims are provided merely as examples of clarification and should in no way be construed as limiting the claims.

Claims

**Claim 1** A shaft having a longitudinal axis, and A tissue grasper assembly including one or more elastic grasper arms, wherein the one or more elastic grasper arms extend along the longitudinal axis of the shaft inside the shaft, in a closed configuration, and the one or more grasper arms extend laterally away from the longitudinal axis of the shaft, in an open configuration outside the shaft, and is expandable between the open configuration and the closed configuration, a tissue grasper assembly, A grasper surface associated with at least one of the grasper arms and shaped and configured to engage body tissue, A controller coupled to the tissue grasper assembly via a controller coupler and configured to operate the grasper arms between the closed configuration and the open configuration, A tissue manipulation device comprising. **Claim 2** The tissue manipulation device according to claim 1, wherein when the grasper arm is disposed outside the shaft, it is elastically biased into an open configuration in a radially outward direction away from the shaft. **Claim 3** The tissue manipulation device according to claim 1 or 2, wherein the grasper arm is elastically held in the open configuration by a direction-changing function portion formed on the distal end of the shaft. **Claim 4** The tissue manipulation device according to any one of claims 1 to 3, wherein the tissue grasper assembly is separable from the shaft and the controller so as to remain in a state of holding body tissue. **Claim 5** The tissue manipulation device according to claim 4, further comprising a locking mechanism engageable to hold at least one grasper arm engaged with tissue when the tissue grasper assembly is separated from the shaft and the controller. **Claim 6** The tissue manipulation device according to claim 4, further comprising a controller coupler coupled between the grasper arm and the controller and movable to operate at least one grasper arm between the closed configuration and the open configuration when the controller is actuated, and the controller is separable from the controller coupler for implanting the tissue grasper assembly. **Claim 7** The tissue holding device according to claim 4, wherein the tissue holding assembly further includes a capsule coupled to the shaft, the holding arms are coupled to the shaft via the capsule, and the tissue holding assembly is separable from the shaft and the controller together with the capsule so as to remain in a state of holding body tissue.

8. The tissue manipulation device according to any one of claims 1 to 8, further comprising a sharp element extending distally from the distal end of the tissue holding assembly and configured to puncture a body tissue wall.

9. The tissue manipulation device according to any one of claims 1 to 9, wherein the at least one holding arm is an elastically biased wire, and the holding surface is provided on a tissue holding mechanism associated with the holding arm.

10. A capsule having a longitudinal axis, One or more elastic holding arms extending along the longitudinal axis of the capsule inside the capsule in a closed configuration and extending laterally away from the longitudinal axis of the capsule outside the capsule in an open configuration, one or more elastic holding arms expandable between the two configurations, A holding surface associated with at least one of the holding arms and shaped and configured to engage body tissue, A controller coupler coupled to at least one of the holding arms and movable to operate the at least one holding arm between the closed configuration and the open configuration, A tissue holding assembly comprising.

11. The tissue holding assembly according to claim 11, further comprising a locking mechanism engageable to hold the tissue holding assembly in an engaged configuration with the tissue.

12. The tissue holding assembly according to claim 11 or 12, wherein the capsule is configured to couple to the distal end of the shaft.

13. The tissue holding assembly according to any one of claims 11 to 13, wherein the capsule has a proximal end and a distal end, and one or more holding arms extend from each of the proximal end and the distal end of the capsule.

14. The tissue grasper assembly according to any one of claims 11 to 15, further comprising a sharp element that extends distally from the tissue grasper assembly and is configured to pierce a body tissue wall.

15. The tissue grasper assembly according to any one of claims 11 to 15, wherein at least one of the grasper arms is elastically held in an open configuration by a direction-changing function portion formed on the distal end of the shaft.

Images