GRASPING DEVICES, SYSTEMS AND METHODS FOR TISSUE APPROXIMATION AND ADHESION CRIMING - Patent application

Abstract

A tissue manipulation system including a tissue manipulation device having a tissue grasper assembly having at least one grasper arm operably coupled to a shaft for movement between a closed configuration and an open configuration. The at least one grasper arm may be pivotally coupled to the shaft via a collar or the like. A tissue manipulation device controller is coupled to the tissue grasper assembly for movement of the at least one grasper arm between the closed and open configurations. The tissue grasper assembly is positionable to approximate the distal tissue wall to the proximal tissue wall. The tissue grasper assembly may be deployable (e.g., by detaching from the shaft) to remain in place while holding the distal and proximal tissue walls in adhesive compression.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to devices and methods for manipulating tissue walls and / or approximating tissue walls and / or maintaining tissue walls in adherent compression. [Background technology]

[0002] Tissue approximation is useful for a variety of 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 relative to another tissue wall, to form an anastomosis between adjacent body lumens or to repair body tissue. Challenges arise in moving a lumen toward another lumen and keeping the two in place.

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

[0004] This Summary of the disclosure is provided to aid in understanding, as those skilled in the art will appreciate that each of the various aspects and features of the disclosure can be advantageously used separately in some instances, or in combination with other aspects and features of the disclosure in other instances. The inclusion or exclusion of an element, component, or the like in this Summary is not intended to limit the scope of the claimed subject matter.

[0005] The present disclosure is directed to tissue manipulation devices and systems capable of manipulating, clamping, grasping, approximating, drawing, pulling, holding, etc. (such terms are used interchangeably herein, without any limitation intended) tissue walls. Optionally, the devices and systems can be used to hold tissue together in an adherent crimp. It is desirable to provide improved protocols and access, and tissue gripping / clamping tools, devices, and systems for drawing tissue together, such as to form an anastomosis or repair tissue. It is further desirable to provide protocols, tools, devices, and systems that facilitate a more rapid method for forming an anastomosis. It is further desirable to provide protocols, tools, devices, and systems for holding tissue in an adherent crimp (e.g., while also minimizing any risk of leakage between tissues).

[0006] In various embodiments described within the present disclosure or otherwise, the present subject matter is directed to tissue manipulation devices and systems capable of manipulating, clamping, grasping, approximating, drawing, pulling, holding, etc. (such terms are used interchangeably herein, without any limitation intended) tissue walls. Optionally, the devices and systems can be used to hold tissue together in an adhesive compression.

[0007] In one aspect, the present disclosure relates to a tissue manipulation device comprising a shaft, a tissue grasper assembly coupled to a distal end of the shaft, and a controller coupled to the tissue grasper assembly. In some embodiments, the tissue grasper assembly includes one or more grasper arms operable between a closed configuration extending along the shaft and an open configuration extending away from the shaft. In some embodiments, the controller is configured to operate the grasper arms between the closed and open configurations. In some embodiments, at least one of the grasper arms has a grasper surface shaped and configured to engage body tissue, such that when the at least one grasper arm is in the open configuration and the grasper surface contacts body tissue and the tissue manipulation device is moved in a proximal direction, the tissue manipulation device moves the body tissue in a proximal direction as well.

[0008] In some embodiments, the grasper arm is pivotally coupled to the shaft. In some embodiments, the tissue grasper assembly is separable from the shaft and controller such that the tissue grasper assembly remains in place grasping the body tissue.

[0009] In some embodiments, the tissue grasper assembly includes a locking mechanism engageable to hold at least one grasper arm in one of a closed or open configuration when the tissue grasper assembly is separated from the shaft and controller.

[0010] In some embodiments, the tissue manipulation device further comprises a controller coupler coupled between the grasper arms and the controller and movable upon actuation of the controller to move the at least one grasper arm between the closed configuration and the open configuration.

[0011] In some embodiments, the tissue grasper assembly further includes a collar coupled to the shaft, the grasper arms being coupled to the shaft via the collar. In some embodiments, the collar and the controller coupler include an interengaging locking mechanism configured to hold the controller coupler in place to hold the at least one gripper arm in a closed configuration.

[0012] In some embodiments, the controller coupling includes a plurality of linkage arms coupled to move the gripper arms between the closed and open configurations. In some embodiments, the controller coupling includes at least two controller elements coupled to corresponding first and second gripper arms to independently control the first and second gripper arms.

[0013] According to other or additional aspects, the present disclosure relates to a tissue grasper assembly comprising a collar configured to couple with a distal end of a shaft, one or more grasper arms pivotally coupled to the collar, and a controller coupler coupled to at least one of the grasper arms and movable to operate the at least one grasper arm between a closed configuration extending along the collar and an open configuration extending away from the collar. In some embodiments, each grasper arm has a grasper surface shaped and configured to engage body tissue. In some embodiments, when in the closed configuration, the grasper surface is configured to hold the body tissue between the grasper surface and the collar.

[0014] In some embodiments, the collar and grasper arms have matching outer surface contours to provide a low profile profile for the tissue grasper assembly when the grasper arms are in a closed configuration.

[0015] In some embodiments, each of the grasper arms has a coupled end coupled to the collar and a free end extending away from the collar, and the free end of at least one of the grasper arms includes a grasping feature that facilitates engagement of the free end of the at least one grasper arm with body tissue.

[0016] In some embodiments, the tissue grasper further comprises a sharp element extending distally from the tissue grasper assembly and configured to pierce a body tissue wall. In some embodiments, the controller coupling includes a plurality of linkage arms coupled to move the gripper arms between the closed and open configurations.

[0017] According to other or additional aspects, the present disclosure relates to a method of manipulating tissue using a tissue manipulation device, the method including extending the tissue manipulation device through a proximal tissue wall and 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 to pivot at least one grasper arm relative to the tissue manipulation device controller to an open configuration that distally engages 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. In some embodiments, the tissue manipulation device comprises a shaft and a tissue grasper assembly. In some embodiments, the tissue grasper assembly includes at least one moveable grasper arm pivotally coupled to the shaft and in a closed configuration extending along the shaft when the tissue manipulation device is extended through the proximal and distal tissue walls.

[0018] In some embodiments, the distal end of the tissue grasper assembly includes a sharp element, and the method further includes extending the tissue manipulation device through the proximal and distal tissue walls and puncturing the proximal and distal tissue walls using the sharp element.

[0019] 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.

[0020] In some embodiments, the tissue grasper assembly includes a collar coupling the tissue grasper assembly to the shaft and a controller coupler coupling the tissue manipulation device controller to the at least one grasper arm, and the method further includes locking the controller coupler with the collar to hold the tissue grasper assembly in a configuration grasping the proximal and distal tissue walls in adherent compression.

[0021] In some embodiments, the method further includes actuating the tissue manipulation device controller to pivot at least one grasper arm to a closed configuration in which the grasper arm engages the distal tissue wall and holds the distal tissue wall in a predetermined position relative to the proximal tissue wall when the tissue manipulation device is operated to move or hold the distal tissue wall in a predetermined position relative to the proximal tissue wall.

[0022] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. Although the following disclosure is presented in terms of aspects or embodiments, it should be understood that each aspect can be claimed separately or in combination with aspects and features of that embodiment or any other embodiment.

[0023] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and are not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the figures in the drawings may be changed. For example, the devices may be enlarged so that details can be discerned, but are also intended to be reduced in size, for example, in relation to fitting into a working channel of a delivery catheter or endoscope. In these figures, identical, nearly identical, or equivalent elements are typically represented by the same reference character, and similar elements are typically designated by similar reference numbers that differ by 100, and redundant descriptions are omitted. For purposes of clarity and simplicity, not every element is labeled in every figure, and not every element of each embodiment is shown unless illustration is necessary to enable a person skilled in the art to understand the present disclosure.

[0024] The detailed description will be better understood in conjunction with the accompanying drawings, in which like reference characters represent like elements and in which: [Brief description of the drawings]

[0025] [Figure 1] FIG. 1 is a schematic diagram of the human gastrointestinal system as an exemplary environment in which embodiments of the present disclosure may be applied or used or placed. [Diagram 2] FIG. 1 is a proximal perspective view of a tissue manipulation device formed in accordance with the principles of the present disclosure and shown in a closed configuration for delivery to a treatment site. [Diagram 3] FIG. 1 is a proximal perspective view of a tissue manipulation device formed in accordance with the principles of the present disclosure and shown in an open configuration for manipulating tissue. [Figure 4] 4 is a cross-sectional view taken along line IV-IV of FIG. 2 showing one embodiment of a coupler between a grasper arm and a controller of a tissue manipulation device, with the grasper arm and coupler in an open configuration, formed in accordance with the principles of the present disclosure. [Diagram 5]4 is a cross-sectional view taken along line VV of FIG. 3 showing one embodiment of a coupler between a grasper arm and a controller of a tissue manipulation device, with the grasper arm and coupler in a closed configuration, formed in accordance with the principles of the present disclosure. [Figure 6] 1 is one embodiment of a gripping area according to the present disclosure. [Figure 7A] 11A-11C illustrate sequential positions of a tissue manipulation device formed in accordance with the principles of the present disclosure relative to tissue that is to be moved into an adhesive compression state. [Figure 7B] 11A-11C illustrate sequential positions of a tissue manipulation device formed in accordance with the principles of the present disclosure relative to tissue that is to be moved into an adhesive compression state. [Figure 7C] 11A-11C illustrate sequential positions of a tissue manipulation device formed in accordance with the principles of the present disclosure relative to tissue that is to be moved into an adhesive compression state. [Figure 7D] 11A-11C illustrate sequential positions of a tissue manipulation device formed in accordance with the principles of the present disclosure relative to tissue that is to be moved into an adhesive compression state. [Figure 8A] 7D shows an example of a further position of the tissue manipulation device after the position shown in FIG. 7D. [Figure 8B] 7D shows an example of a further position of the tissue manipulation device after the position shown in FIG. 7D. [Figure 9] 7D shows an alternative embodiment of a further position of the tissue manipulation device after the position shown in FIG. 7D. [Figure 10] FIG. 2 is an elevational view of one embodiment of a distal end of a tissue manipulation device configured to pierce tissue and with grasper arms in a closed position. [Figure 11A] FIG. 1 is an elevated partial perspective view of one embodiment of a grasper arm of a tissue manipulation device, formed in accordance with the principles of the present disclosure to enhance tissue grasping, in an open position; [Figure 11B] 1 is an elevational view of one embodiment of a grasper arm of a tissue manipulation device formed in accordance with the principles of the present disclosure to enhance tissue grasping, in a closed position; FIG. [Figure 12A]11A and 11B show sequential positions of a tissue manipulation device having grasper arms formed similarly to those of FIGS. 11A and 11B relative to a tissue defect to be repaired in accordance with the principles of the present disclosure. [Figure 12B] 11A and 11B show sequential positions of a tissue manipulation device having grasper arms formed similarly to those of FIGS. 11A and 11B relative to a tissue defect to be repaired in accordance with the principles of the present disclosure. [Figure 12C] 11A and 11B show sequential positions of a tissue manipulation device having grasper arms formed similarly to those of FIGS. 11A and 11B relative to a tissue defect to be repaired in accordance with the principles of the present disclosure. [Figure 12D] 11A and 11B show sequential positions of a tissue manipulation device having grasper arms formed similarly to those of FIGS. 11A and 11B relative to a tissue defect to be repaired in accordance with the principles of the present disclosure. [Figure 13] FIG. 1 is a cross-sectional view of one embodiment of a controller according to the principles of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] The following detailed description should be read with reference to the drawings showing exemplary embodiments. It should be understood that the disclosure is not limited to the specific embodiments described and may therefore be modified. All devices and systems and methods discussed herein are examples of devices, systems, and / or methods implemented according to one or more principles of the disclosure. Each example of an embodiment is provided as an illustration and is merely an example, not the only way to implement these principles. Thus, references to elements, structures, or features in the drawings should be understood as references to examples of embodiments of the disclosure and should not be understood as limiting the disclosure to the specific elements, structures, or features shown. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading the disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the 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 yet further embodiments. Thus, it is intended that the present subject matter covers such modifications and variations as come within the scope of the appended claims and their equivalents.

[0027] It will be understood that in this application, the disclosure is described in various levels of detail. In certain instances, details that are not necessary for a person skilled in the art to understand the disclosure or that make it difficult for the person skilled in the art to appreciate other details may be omitted. The terms used herein are for the purpose of describing certain embodiments only and are not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as commonly understood by those skilled in the art to which the disclosure belongs. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0028] As used herein, "proximal" refers to a direction or location, etc., closest to a user (such as a medical professional, clinician, technician, operator, or physician, such terms being used interchangeably, without any limitation or other intent) when using the device (e.g., when introducing the device into a patient or when implanting, positioning, or delivering), and "distal" refers to a direction or location, etc., furthest from a user when using the device (e.g., when introducing the device into a patient or when implanting, positioning, or delivering). "Longitudinal" means extending along the longer or greater dimension of an element. "Center" means at least approximately intersecting a center point, and "center axis" means, with respect to an opening, a line that at least approximately intersects the center point of the opening and extends longitudinally along the length of the opening when the opening comprises, for example, a tubular element, channel, or hole.

[0029] As will now be described with reference to the drawings, devices, systems, and methods for manipulating tissue walls, approximating tissue walls, and / or maintaining tissue walls in adherent compression at a treatment site are disclosed herein. The medical devices, instruments, tools, and the like of the present disclosure may include various medical devices for accessing body passageways, including, but not limited to, duodenoscopes, catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, and the like. Other terms such as manipulating and / or clamping, grasping, approximating, drawing, pulling, holding, and the like will be referred to herein, with the understanding that such terms are used interchangeably herein without any limitation intended. Tissue walls, such as, but not limited to, organ or lumen walls, may be drawn together or to another tissue wall for approximation, for example, to form an anastomosis, for example, to hold the tissue wall in adherent compression. For example, the devices and systems can engage and pull portions of the small intestine toward the stomach wall, such as by puncturing through the small intestine and stomach walls, to hold the lumens / tissues together. Such methods and apparatus can also be used for access to and from 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 duct and gallbladder, as well as for vascular applications. Alternatively, separate ends of tissue walls can be drawn together to close the defect therebetween. It will be understood that the present disclosure should not be construed as limited to such procedures or end results. Furthermore, while treatment sites are mentioned, such references are merely for convenience and are not intended to limit the scope of the present disclosure.

[0030] In accordance with various principles of the present disclosure, the distal end of the tissue manipulation device has an elongate member (e.g., catheter, shaft, etc.), referred to herein for simplicity and without any intention of limitation as a shaft, through which (or along) one or more grasper arms can extend. In some embodiments, the shaft is in the form of a collar. In some embodiments, the shaft includes a collar formed separately from and coupled to the shaft, and optionally removable from the shaft for placement of a tissue grasper assembly (including the grasper arms) of the tissue manipulation device. The grasper arms are operable between a closed configuration within the shaft (and within a lumen defined within the shaft, generally extending along the longitudinal or axial extent of the lumen and shaft) and an open configuration in which the grasper arms expand or extend away from the shaft, e.g., to engage a tissue wall. In some embodiments, the grasper arms are resiliently biased to be held in the open configuration capable of engaging, e.g., tissue. In some embodiments, the grasper arms are resiliently biased to expand or otherwise extend into the open configuration upon release or deployment from the shaft, hi other embodiments, another element of the tissue manipulation device can hold the resiliently biased grasper arms in the open configuration.

[0031] A controller can extend along (e.g., through) the flexible elongate member from a proximal end of the flexible elongate member to a distal end of the flexible elongate member, the distal end of the controller being coupled or engaged with at least one grasper arm to control movement of that grasper arm as desired or dictated by the procedure for which the tissue manipulation device is being used. The proximal end of the controller can be engaged, coupled, or otherwise associated with a control handle that facilitates actuation of the controller. The controller can be manipulated, such as via its proximal end, using any of a variety of control handles known or disclosed in the art, the particular details of which configuration are not limiting the scope of the present disclosure.

[0032] The distal end of the controller can be configured in any of a variety of ways to effect movement of the grasper arms. The various distal configurations of the controller, which typically engage or otherwise couple or associate with the grasper arms (such terms are used interchangeably herein, without any limitation), can be compatible with various proximal configurations of the controller through which the controller is actuated to manipulate, control or actuate (such terms are used interchangeably herein, without any limitation). In some embodiments, the grasper arms are coupled to the tissue manipulation device via a linkage arm. In some embodiments, the grasper arms can be actuated between a closed configuration and an open configuration by advancing the controller distally or retracting it proximally to manipulate the relative position of the grasper arms.

[0033] According to some embodiments disclosed herein, the grasper arms can be coupled to a tissue grasper assembly configured to be releasable from the tissue manipulation device shaft for deployment, where the shaft can be withdrawn while the tissue grasper assembly maintains the approximated tissues in adherent crimped relation to one another.

[0034] According to some embodiments disclosed herein, the distal end of the tissue manipulation device can be configured to facilitate passage of the distal end through the tissue wall to be manipulated. In some embodiments, the distal end of the tissue manipulation device is provided with a sharp tip, such as a needle or other sharp element, capable of piercing the tissue wall. In some embodiments, the sharp tip can be associated with the shaft and / or the grasper arm.

[0035] Various features can be provided to facilitate grasping, clamping, moving, etc. (such terms are used interchangeably herein without any limitation) of tissue. According to some embodiments described herein, at least one of the grasper arms can be shaped and configured to enhance tissue engagement and / or gripping. In some embodiments, at least one of the free ends (e.g., distal ends) of at least one of the grasper arms is shaped and configured to enhance tissue engagement and / or gripping, such as by hooking onto tissue. In some embodiments, one or more tissue gripping features, such as hooks, are provided along one or both of the grasper arms between an attachment end (the end that is coupled to the remainder of the tissue manipulation device, such as the distal end of the grasper arm) and the free end of the grasper arm.

[0036] Various embodiments of tissue manipulation devices, systems, and methods will now be described with reference to examples shown in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc. indicate that one or more particular features, structures, and / or characteristics according to the principles of the present disclosure may be included in connection with that embodiment. However, such references do not necessarily mean that all embodiments include that particular 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 thereof. Moreover, references in various places herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc. are not necessarily all referring to the same embodiment, and separate or alternative embodiments are not necessarily mutually exclusive of other embodiments. It is to be understood that when a particular feature, structure, and / or characteristic is described in connection with one embodiment, such feature, structure, and / or characteristic can also be used in connection with other embodiments, whether or not explicitly described, unless expressly stated otherwise. It is further to be understood that 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 this disclosure, since it would be too cumbersome to describe all of the many possible combinations and subcombinations of features, structures, and / or characteristics. Furthermore, various features, structures, and / or characteristics are described that may be exhibited 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 with respect to some embodiments but not with respect to other embodiments. Therefore, the present invention is not limited to only the embodiments specifically described herein.

[0037] Referring now to the drawings, a tissue manipulation system 100 formed in accordance with the principles of the present disclosure, such as for creating an anastomosis between a stomach S and a portion of the small intestine SI, such as the jejunum J, is shown in a schematic diagram of the gastrointestinal system. It will be understood that the gastrointestinal system is merely one of a number of anatomical locations in which a tissue manipulation system 100 formed in accordance with the principles of the present disclosure may be used, and that the particular anatomical location does not affect the scope of the present disclosure or limit the disclosed tissue manipulation system 100. The tissue manipulation system 100 may include a delivery device, such as a flexible elongate member 102 (the term flexible elongate member is used herein for convenience and without any limitation to refer to the delivery device), such as an endoscope, cannula, delivery shaft, etc., having a working channel extending therethrough 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 at a distal end 111 of the tissue manipulation device. A tissue manipulation device controller 130 (shown diagrammatically) extends from the tissue grasper assembly 120 to the proximal end 103 of the tissue manipulation system 100 for access and operation by a user (e.g., a medical professional such as a physician, technician, endoscopist, or an automated system or otherwise) to control the tissue grasper assembly 120. The tissue manipulation device 110 may be positioned relative to the tissue manipulation system 100 such that the tissue grasper assembly 120 extends from the distal end 101 of the tissue manipulation system 100 and such that the proximal end 133 of the tissue manipulation device controller 130 is disposed at or along the proximal end 103 of the tissue manipulation system 100. A control handle 104 may be provided at the proximal end 103 of the tissue manipulation system 100 and may be associated with a tissue manipulation device controller 130 and / or a controller of the flexible elongate member 102 (any controller known or known in the art and not shown as not necessary for a complete understanding of the tissue manipulation device 110).

[0038] The tissue manipulation device 110 is configured to be delivered to the treatment site TS through the flexible elongate member 102 according to techniques known or known to a medical professional for advancing a device or system through a patient's anatomy to the treatment site TS. The distal end 111 of the tissue manipulation device 110 may have a profile configured to easily pass through an opening through a tissue wall, such as that shown in FIG. 2. For example, the distal end 111 of the tissue manipulation device 110 may be configured in a closed position having a substantially blunt surface to easily pass through an opening or passage designated for the tissue manipulation device 110 (e.g., created for passage of the tissue manipulation device or created by the tissue manipulation device, as discussed in more detail below) without causing any undesired damage (e.g., abrasions, lacerations, lacerations, etc.). In some embodiments, the tissue manipulation device 110 has a shaft 116 having a distal end 115 to which a tissue grasper assembly 120 is coupled, the outer contour (e.g., cross-sectional shape) of a (longitudinal / axial) side of the tissue grasper assembly 120 substantially matching the outer contour (e.g., cross-sectional shape) of a (longitudinal / axial) side of the shaft 116. For example, if the shaft 116 has a substantially circular cross-section, the tissue grasper assembly 120 may have an outer surface that is concave about the longitudinal axis LA of the shaft 116.

[0039] According to one aspect of the present disclosure, tissue grasper assembly 120 includes one or more grasper arms 122 operably coupled to shaft 116. In some embodiments, grasper arms 122 are pivotally coupled to shaft 116 about pivot axis PA. The grasper arms 122 are operable or pivotable from a closed configuration in FIG. 2 to an open configuration as shown in FIG. 3, in which the grasper arms 122 are spaced apart or spaced apart from shaft 116. In the open configuration, the grasper arms 122 extend away from the shaft 116 with their free ends 121 (as used herein, a "free end" of an element is a terminal end beyond which such element does not extend) spaced apart from the shaft 116, and / or the grasper arms 122 themselves are shaped and configured to present a grasper surface 125 having a sufficient grasper arm surface area shaped and configured to engage and manipulate tissue as desired. One or more of the grasper arms 122 are coupled to the shaft 116 via a grasper arm coupler 124, such as a pivot or other structure that allows relative movement (e.g., pivoting or rotation) of the grasper arms 122 with respect to the shaft 116. In some embodiments, the tissue grasper assembly 120 includes a collar 126 mounted on the distal end 115 of the shaft 116, and the grasper arms 122 are coupled to the shaft 116 via the collar 126. In some embodiments, the gripper arm coupler 124 is provided at a coupled end 123 of the gripper arm 122 that is spaced from the free end 121 of the gripper arm 122. In some embodiments, the gripper arm coupled end 123 is formed at a free end of the gripper arm 122 opposite the free end 121 of the gripper arm 122. Although the gripper arms 122 are shown as coupled with the free ends 121 extending proximally and the coupled ends 123 being proximal to the free ends 121, it will be understood that other configurations and orientations are within the scope of the present disclosure.

[0040] The tissue manipulation device controller 130 is coupled to the grasper arm 122 and extends proximally, such as to the proximal end 113 of the tissue manipulation device 110 and / or the proximal end 103 of the tissue manipulation system 100, for access by a user to actuate the tissue manipulation device controller 130 to operate the grasper arm 122 and thus the shaft 116 as desired. In some embodiments, the tissue manipulation device controller 130 is moved distally or proximally to actuate the grasper arm 122. However, other operations or controls of the tissue manipulation device controller 130 are within the scope of the present disclosure, and these particular operations are not critical to the broad principles of the present disclosure.

[0041] The tissue manipulation device controller 130 may be coupled to the grasper arm 122 by a coupler as known or known in the art capable of transmitting control of a desired motion or movement from the tissue manipulation device controller 130 to the grasper arm 122. In some embodiments, as shown in Figures 4 and 5, the tissue manipulation device controller 130 may include a controller element 132, such as a wire, having an attachment 134 at its distal end 131 that is coupled to the tissue grasper assembly 120 via a controller coupler 140 and configured to transmit a desired motion to the controller coupler 140 to actuate the grasper arm 122.

[0042] 4 and 5, the controller coupler 140 is in the form of linkage arms 142a, 142b, 142c, 142d. The controller element 132 of the tissue manipulation device controller 130 can be coupled to the controller coupler 140 (e.g., via a mount 134 at the distal end 131 of the controller element 132) via a proximal end 143a, 143b, etc. of the proximal linkage arms 142a, 142b of the controller coupler 140, such as via a pivotable or rotatable coupler (e.g., a pivot shaft). The distal ends 141a, 141b of the proximal linkage arms 142a, 142b can be moveable (e.g., pivotable or rotatable) relative to the proximal ends 143c, 143d of the distal linkage arms 142c, 142d. Distal ends 141c, 141d of distal linkage arms 142c, 142d can be moveable (e.g., pivotable or rotatable) relative to coupling end 123 of grasper arm 122, such as via grasper arm coupler 124. As can be understood with reference to the closed position shown in FIG. 4 and the open position shown in FIG. 5, distal movement of tissue manipulation device controller 130 actuates controller coupler 140 to move from the configuration shown in FIG. 4 to the configuration shown in FIG. 5. As can be seen, the linkage arms 142a, 142b, 142c, 142d move from a folded configuration (when the tissue grasper assembly 120 is in the closed configuration of FIG. 4) to an expanded configuration (when the tissue grasper assembly 120 is in the open configuration of FIG. 5), and in so expanding, the linkage arms 142a, 142b, 142c, 142d move the grasper arms 122 (e.g., by contacting) to move the grasper arms 122 away from the closed configuration (adjacent to, on or along the shaft 116) and into an open configuration spaced apart from and / or extending away from the shaft 116. In some embodiments, the tissue manipulation device controller 130 can be separated from the tissue grasper assembly 120 while leaving the tissue grasper assembly 120 in place, as shown in FIG. 6 and described in further detail below.It will be understood that other configurations of the tissue manipulation device controller and controller coupler are within the scope and spirit of the present disclosure, and that the operation and movement of the grasper arms are not limited to any particular configuration of the controller or controller coupler.

[0043] Examples of operation and movement of a tissue manipulation device 110 formed in accordance with the principles of the present disclosure for use in accordance with certain aspects of the present disclosure are shown in Figures 8A-8D. As shown in Figure 7A, the tissue manipulation device 110 is shown having already been advanced distally through the distal end of a delivery device (such as the flexible elongate member 102, if used) and through a proximal body cavity or lumen and through a proximal tissue wall PTW (e.g., an organ wall such as a stomach wall, or a lumen wall distal to the proximal body cavity or lumen), and advanced through a distal tissue wall DTW into a distal body cavity or lumen. In Figure 7B, the tissue grasper assembly 120 is shown being or having been actuated to an open configuration (such as by operation of the tissue manipulation device controller 130, not shown in this figure). The tissue grasper assembly 120 is then moved proximally to engage the distal tissue wall DTW, as shown in Figure 7C. Optionally (as shown in FIG. 7C ), the grasper arms 122 of the tissue grasper assembly 120 can be actuated into a closed or partially closed configuration to bring a grasper surface 125 of the grasper arms 122 (that faces the shaft 116 when the grasper arms 122 are in the closed configuration) closer to the shaft 116, thereby holding the distal tissue wall DTW between the grasper surface 125 and the shaft 116. However, the grasper arms 122 can be left in an open configuration, if desired. As shown in FIG. 7D , the distal tissue wall DTW can then be manipulated proximally (e.g., the distal lumen can be moved proximally), e.g., toward the proximal tissue wall PTW, and optionally into adherent compression with the proximal tissue wall PTW, as desired.

[0044] According to one aspect of the disclosure, as shown in Figures 8A and 8B, once the distal tissue wall DTW has been moved into adherent compression with the proximal tissue wall PTW, as shown in Figure 8A, the tissue grasper assembly 120 can be operated to disengage the distal tissue wall DTW. The grasper arms 122 can be returned to a closed configuration and moved proximally away from the treatment site TS, e.g., out of the distal cavity, as shown in Figure 8B, such as for withdrawal from the body. Further procedures can then be performed at the treatment site TS, as known or known in the medical arts.

[0045] According to one aspect of the disclosure, as shown in FIG. 9, once the distal tissue wall DTW has been moved into adherent compression with the proximal tissue wall PTW, such as after the position shown in FIG. 7D, the shaft 116 can be decoupled / removed from the tissue grasper assembly 120. The tissue grasper assembly 120 is thereby left in place holding the proximal and distal tissue walls PTW and DTW together so that further procedures can be performed in the area of ​​the treatment site TS or to reinforce holding together tissue that is held together using a stent or otherwise. In the embodiment shown in FIG. 9, the grasper arms 122 are in a closed configuration, holding the distal tissue wall DTW between the grasper arms 122 and the collar 126 of the tissue grasper assembly 120. However, alternative configurations that allow the grasper arms 122 to remain in an open configuration relative to the distal tissue wall DTW are within the scope and spirit of the disclosure.

[0046] In accordance with the principles of the present disclosure, any of a variety of locking mechanisms may be provided to hold the grasper arms 122 in place (in a closed configuration as shown in FIG. 9 or in an open, extended configuration) once the shaft 116 is decoupled from the grasper arms 122. In one embodiment, as shown in FIG. 6 (referenced briefly above), the tissue grasper assembly 120 may include a locking mechanism 128 configured to engage or interengage a mount 134 on the proximal end 143 of the tissue manipulation device controller 130 and / or controller coupler 140 with the collar 126. Manipulating the tissue manipulation device controller 130 (e.g., moving proximally and / or rotating or otherwise moving relative to the collar 126) may engage or actuate the locking mechanism 128 to hold the tissue grasper assembly 120 in the closed configuration. In one embodiment, as shown for example in FIG. 6, the locking mechanism is in the form of an inwardly directed flange 127 on the collar 126 and a corresponding flange 137 on the fitting 134. The fitting flange 137 may be sized to be slightly larger in width (e.g., diameter) than the width of the collar flange 127 and may be resiliently flexible such that as the fitting flange 137 extends past the collar flange 127, the fitting flange 137 is held in place proximal to the collar flange 127. In some embodiments, the fitting flange 137 is defined by a distally extending groove 139 that surrounds the circumference of the fitting 134 such that proximal and distal movement of the fitting 134 and controller coupling 140 is limited by engagement of the collar flange 127 within the groove 139. It will be understood that other configurations, such as for holding the gripper arms 122 in an open configuration, are within the scope of the present disclosure.Once the controller coupler 140 is held in the desired position to hold the grasper arms 122 in the desired configuration, the tissue manipulation device controller 130 can be decoupled (e.g., disconnected) from the controller coupler 140, and the shaft 116 can be decoupled from the controller coupler 140, as shown, leaving the controller coupler 140 in place holding the distal and proximal tissue walls DTW and PTW in the desired relative positions (e.g., in adhesive compression). Any of a variety of configurations and methods of decoupling such components known or known in the art can be used without affecting the scope of the present disclosure.

[0047] Referring again to FIG. 7A, the opening through the tissue wall through which the tissue grasper assembly 120 passes can be pre-formed in the tissue wall (such as by a separate cutting instrument) prior to insertion of the tissue grasper assembly 120 through the opening. In some embodiments, the tissue grasper assembly 120 can be configured to pierce and then pass through the tissue wall to facilitate the tissue manipulation procedure, such as by reducing the action and / or the required instruments or devices. In some embodiments, the tissue grasper assembly 120 can be provided with a sharpened distal end extending distally from the tissue grasper assembly 120. In one embodiment, as shown in FIG. 10, a sharpened element 150, such as a needle, can be formed or disposed at the distal end 121 of the tissue grasper assembly 120 (e.g., on the distal end of the collar 126, if provided, or on at least one of the grasper arms 122). Distal advancement of the tissue grasper assembly 120 toward a tissue wall can cause the sharp element 150 to engage the tissue wall, and further advancement can cause the sharp element 150 to pierce the tissue wall, thereby allowing the tissue grasper assembly 120 to pass through the tissue wall. As will be appreciated, the grasper arms 122 preferably remain in a closed configuration as shown as the sharp element 150 pierces the tissue wall. Further advancement of the tissue manipulation device 110 can cause the sharp element 150 at the distal end 151 of the tissue grasper assembly 120 to advance toward another tissue wall, thereby piercing the other tissue wall, thereby allowing the tissue grasper assembly 120 to pass through the tissue wall as well. Further manipulation of the tissue manipulation device 110 can be performed as shown in any of Figures 7B, 7C, 7D, 8A, 8B, and 9.

[0048] 7C, in some embodiments, it may be desirable to provide gripping features on the grasper arms 122 to facilitate grasping, clamping, moving, etc., tissue. In one embodiment, as shown in FIGS. 11A and 11B, the free ends 121 of one or more of the grasper arms 122 may be provided with tissue gripping features 160, such as barbs, hooks, jaws, or other tissue-engaging protrusions. Additionally or alternatively, one or more gripping features 160 may be provided along the grasper surface 125 between the free ends 121 and the coupled ends 123 of the grasper arms 122. The tissue gripping features 160 are configured to enhance the gripping of (e.g., latching onto) tissue such that the grasper arms 122 do not inadvertently move relative to a tissue wall being manipulated or held in place by the tissue grasper assembly 120 that is left in place for such function (e.g., as described above with reference to FIG. 9). According to some aspects of the present disclosure, grasping features 160 can be used to facilitate use of tissue grasper assembly 120 to repair defects, as will now be described.

[0049] As can be appreciated, tissue manipulation device 110 according to the principles of the present disclosure can be used in a variety of procedures other than drawing and / or holding together tissue walls of different organs or lumens. For example, as shown in Figures 12A-12D, tissue manipulation device 110 can be used to repair a defect, such as by drawing together tissue walls on different sides or edges of the defect. As shown in Figure 12A, tissue grasper assembly 120 can be advanced to tissue defect TD and one of the grasper arms 122 can be engaged with a tissue wall along a side or edge of tissue defect TD, such as by engaging a grasping feature 160 of grasper arm 122 with the tissue. The grasper arms 122 are in an open configuration as shown in FIG. 12A to facilitate engagement of a portion of the grasper arms 122 (e.g., the distal end 121 of the grasper arms 122, the grasper surfaces 125 of the grasper arms 122, the grasping feature 160 of the grasper arms 122, etc.) with tissue. The grasper arms 122 are then actuated to a closed configuration, as shown in FIG. 12B, to maintain the relative position and grasp of the tissue grasper assembly 120 and the grasped tissue region. The tissue grasper assembly 120, along with the grasped tissue, is then actuated across the defect, as shown in FIG. 13C, to extend another grasper arm 122 to engage another region of the tissue wall along the tissue defect TD (e.g., the tissue wall of the tissue defect TD on the other side of the tissue wall section already grasped). The gripping features 160 of the grasper arms 122 engaging the initially grasped tissue area facilitate maintaining the grasper arms 122 on the initially grasped tissue area even when such grasper arms 122 are actuated to an open configuration. Closure of the defect can then be accomplished by actuating the grasper arms 122, with at least two of them engaged with tissue surrounding the tissue defect TD, to a closed configuration as shown in FIG. 13D. The tissue grasper assemblies 120 are left in place in the closed configuration to hold the tissue walls in adherent compression and reduce the size of the tissue defect TD, thereby allowing the defect to heal.As can be appreciated, the grasping feature 160 can facilitate holding the tissue grasper assembly 120 on the tissue during the entire repair procedure.

[0050] Independent movement of the grasper arms 122 may be desired such that each grasper arm 122 may be independently moved between the open and closed configurations to facilitate procedures such as tissue repair, where it may be desirable for one grasper arm 122 to be in a closed configuration while another grasper arm 122 is in an open configuration. It will be appreciated that independent movement of the grasper arms 122 may facilitate tissue repair without the aid of grasping features 160 on the grasper arms 122 because an initially grasped tissue region may be adequately or appropriately grasped by the tissue grasper assembly 120 by closing the grasper arms 122 engaging such initially grasped tissue region.

[0051] One example of a tissue manipulation device controller 130 and controller coupler 140 that allows for independent movement of the grasper arms 122 is shown in Figure 14. As shown, the tissue manipulation device controller 130 includes two or more controller elements 132, with each controller element 132 engaged with a different grasper arm 122. The operation of the controller elements 132 and controller coupler 140 may be similar to that of the embodiment of Figures 4 and 5, and reference is made to their description. It will be understood that other configurations are within the scope of this disclosure.

[0052] In view of the above, it will be appreciated that the devices, systems, and methods disclosed herein can be used to create one or more anastomoses and can be used with basic endoscopic tools, catheters, laparoscopes, general surgical tools, and the like. For example, a catheter-based stent delivery device can be used with an endoscope to create an anastomosis, for example, between two portions of the intestine. An endoscope-based device can also be used to create an anastomosis between the fundus pouch and a portion of the intestine, such as the jejunum. A combination of a laparoscope-based device and a catheter device, as described herein, can also be used to create a single anastomosis.

[0053] 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 concept, 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 the concept, spirit, scope, or characteristics thereof. For example, various features of the disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of the disclosure can be combined in alternative aspects, embodiments, or configurations. Although the disclosure is presented in terms of embodiments, it should be understood that the various separate features of the subject matter need not all be present to achieve at least some of the desired properties and / or advantages of the subject matter or such individual features. Those skilled in the art will appreciate that the present disclosure can be used with many modifications specifically adapted to particular environments and operating requirements, or with structure, arrangement, proportions, materials, components, and other modifications used in the practice of the present disclosure, without departing from the principles, spirit, or scope of the present disclosure. For example, elements shown as integrally formed can be composed of multiple pieces, or elements shown as multiple pieces can be formed integrally, operations of elements can be reversed or otherwise changed, and elements can be changed in size or dimensions. Similarly, although operations, actions, or steps are described in a particular order, this should not be understood as requiring such a particular order or that all operations, actions, or steps should be performed to achieve desired results. Moreover, 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 desired results.The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims and not limited to the foregoing description or to the specific embodiments or configurations described or illustrated herein. In view of the above, the individual features of any embodiment can be used and claimed separately or in combination with the features of that embodiment or any other embodiment, and the scope of the subject matter being indicated by the appended claims and not limited to the foregoing description.

[0054] In the above description and in the claims that follow, it will be understood that: The phrases "at least one," "one or more," and "and / or," as used herein, are open-ended expressions that operate both conjunctively and disjunctively. The terms "a," "an," "the," "first," "second," etc. do not exclude a plurality. For example, the term "a" or "an" entity, as used herein, refers to one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" can be used interchangeably herein. All directional references (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 for identification purposes only to aid the reader in understanding this disclosure and / or serve to distinguish regions of associated elements from one another, and are not intended to limit the associated elements, particularly with respect to the location, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) should be interpreted broadly and may include intermediate members between groups of elements and relative movement between elements, unless otherwise indicated. Thus, connection references do not necessarily imply that two elements are directly connected and in a fixed relationship to one another. Distinguishing references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another. The following claims are incorporated by reference into this Detailed Description, with each claim standing on its own as a separate embodiment of this disclosure. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

[0055] The following claims are hereby incorporated by reference into this Detailed Description, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term "comprises" / "comprising" does not exclude the presence of other elements or steps. Furthermore, although individual features may be included in different claims, these features may in some cases be advantageously combined, and their inclusion in different claims does not imply that the combination of features is not feasible and / or advantageous. Furthermore, reference to the singular does not exclude a plurality. The terms "a", "an", "the", "first", "second", etc. do not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

Claims

1. A shaft, a tissue grasper assembly including a first grasper arm and a second grasper arm coupled to a distal end of the shaft and operable between a closed configuration extending along the shaft and an open configuration extending away from the shaft; a controller coupled to the tissue grasper assembly and configured to operate the first grasper arm and the second grasper arm between the closed configuration and the open configuration, the first and second grasper arms each have a first end coupled to the distal end of the shaft and extend proximally to a free end disposed adjacent the shaft when in the closed configuration and laterally away from the shaft when in the open configuration; A tissue manipulation device, wherein the first grasper arm and the second grasper arm each have a grasper surface shaped and configured to engage body tissue and hold the body tissue against the shaft, thereby drawing together the body tissue held by the first grasper arm and the body tissue held by the second grasper arm.

2. The tissue manipulation device of claim 1 , wherein the first and second grasper arms are pivotally coupled to the shaft.

3. The tissue manipulation device of claim 1 or 2, wherein the tissue grasper assembly is separable from the shaft and the controller such that the tissue grasper assembly remains in place grasping body tissue.

4. 4. The tissue manipulation device of claim 1, wherein the tissue grasper assembly includes a locking mechanism engageable to hold at least one of the first grasper arm and the second grasper arm in one of the closed configuration or the open configuration when the tissue grasper assembly is separated from the shaft and the controller.

5. 5. The tissue manipulation device of claim 1, further comprising a controller coupler coupled between the first and second grasper arms and the controller and movable upon actuation of the controller to move at least one of the first and second grasper arms between the closed and open configurations.

6. 6. The tissue manipulation device of claim 5, wherein the tissue grasper assembly further comprises a collar coupled to the shaft, the first grasper arm and the second grasper arm being coupled to the shaft via the collar.

7. 7. The tissue manipulation device of claim 6, wherein the collar and the controller coupler include an interengaging locking mechanism configured to hold the controller coupler in a predetermined position to retain at least one of the first and second grasper arms in the closed configuration.

8. The tissue manipulation device of claim 1 , wherein the first and second grasper arms have blunt ends extending away from the distal end of the shaft.

9. 6. The tissue manipulation device of claim 5, wherein the controller coupler comprises a plurality of linkage arms coupled to move the first and second grasper arms between the closed and open configurations.

10. 6. The tissue manipulation device of claim 5, wherein the controller coupler includes at least two controller elements coupled to corresponding first and second grasper arms to independently control the first and second grasper arms.

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