Grasping devices, systems, and methods for tissue approximation and apposition

Abstract

A tissue manipulation system having a tissue manipulation device with a tissue grasper assembly having at least one grasper arm movably coupled to a shaft for movement between a closed configuration and an open configuration. The at least one grasper arm can be pivotably coupled to the shaft, such as via a collar. A tissue manipulation device controller is coupled to the tissue grasper assembly to move the at least one grasper arm between the closed configuration and the open configuration. The tissue grasper assembly can be positioned to approximate a distal tissue wall to a proximal tissue wall. The tissue grasper assembly can be deployed, such as by decoupling from the shaft, to maintain the distal tissue wall and the proximal tissue wall in a position held in apposition.

Description

[0001] Priority

[0002] This application claims priority benefit under 35 USC § 119 to U.S. Provisional Patent Application Serial No. 63 / 073,189, filed September 1, 2020, the disclosure of which is hereby incorporated by reference in its entirety for all purposes. TECHNICAL FIELD

[0003] The present invention relates generally to devices and methods for manipulating, approximating, and / or maintaining tissue walls in apposition. BACKGROUND

[0004] 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 one lumen toward another lumen and anchoring both in place.

[0005] Accordingly, improved tools, devices, systems, and methods for manipulating and moving body organs, tissues, lumens, etc. would be welcome in the medical arts. SUMMARY

[0006] The summary of the disclosure is presented to help understand the invention and those skilled in the art will understand that aspects and features of the disclosure can be used advantageously, either alone or in combination with other aspects and features of the disclosure, in some cases. The inclusion of or exclusion of elements, components, etc. in this summary is not intended to limit the scope of the claimed subject matter.

[0007] The present disclosure relates to a tissue manipulation device and system capable of manipulating, grasping, holding, approximating, approximating, pulling, maintaining, etc. a tissue wall (the terms are used interchangeably herein without intent to limit). Optionally, the device and system can be used to hold tissue in apposition. It would be desirable to provide improved solutions and pathways and tissue grasping / tissue holding tools, devices, and systems for pulling tissue together, such as for forming an anastomosis or repairing tissue. It would further be desirable to provide solutions, tools, devices, and systems that facilitate a faster method of forming an anastomosis. It would further be desirable to provide solutions, tools, devices, and systems for maintaining tissue in apposition (such as while also minimizing any risk of leakage between the tissues).

[0008] In various embodiments described or within the scope of the present disclosure, the subject matter relates to a tissue manipulation device and system capable of manipulating, grasping, holding, approximating, pulling, maintaining, etc. a tissue wall (the terms are used interchangeably herein without intent to limit). Optionally, the device and system can be used to hold tissue in apposition.

[0009] In one aspect, the present disclosure relates to a tissue manipulation device comprising a shaft; a tissue grasper assembly coupled with a distal end of the shaft; and a controller coupled with the tissue grasper assembly. In some embodiments, the tissue grasper assembly comprises one or more grasper arms movable between a closed configuration extending along the shaft and an open configuration away from the shaft. In some embodiments, the controller is configured to move the grasper arms between the closed configuration and the open configuration. In some embodiments, at least one grasper arm has a grasper surface shaped and configured to engage with bodily tissue such that when the at least one grasper arm is in the open configuration and the grasper surface is in contact with the bodily tissue and the tissue manipulation device is moved proximally, the tissue manipulation device also moves the bodily tissue proximally.

[0010] In some embodiments, the grasper arms are pivotably coupled to the shaft.

[0011] In some embodiments, the tissue grasper assembly is separable from the shaft and the controller to maintain the grasped bodily tissue deployed.

[0012] In some embodiments, the tissue grasper assembly comprises a locking feature engageable to maintain the at least one 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.

[0013] In some embodiments, the tissue manipulation device further comprises a controller link 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.

[0014] In some embodiments, the tissue grasper assembly further comprises a collar coupled to the shaft, the grasper arms coupled to the shaft via the collar.

[0015] In some embodiments, the collar and the controller link comprise interengaging locking features configured to fix the controller link in place to maintain the at least one grasper arm in the closed configuration.

[0016] In some embodiments, the controller link comprises a plurality of linkage arms coupled to move the grasper arms between the closed configuration and the open configuration.

[0017] In some embodiments, the controller link comprises at least two controller elements coupled to independently control the first grasper arm and the second grasper arm.

[0018] According to other or additional aspects, the present disclosure is directed to a tissue grasper assembly including a collar configured to couple with a distal end of a shaft; one or more grasper arms pivotably coupled with the collar; and a controller linkage coupled with at least one of the grasper arms and movable to move 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 with bodily tissue. In some embodiments, the grasper surface is configured to hold bodily tissue between the grasper surface and the collar when in the closed configuration.

[0019] In some embodiments, the collar and the grasper arms have matching outer surface profiles to provide a low profile profile to the tissue grasper assembly when the grasper arms are in the closed configuration.

[0020] In some embodiments, each grasper arm has a coupled end coupled with the collar and a free end extending away from the collar, the free end of at least one of the grasper arms including a grasping feature that facilitates engagement of the free end of the at least one grasper arm with bodily tissue.

[0021] In some embodiments, the tissue grasper further includes a sharp element extending distally from the tissue grasper assembly and configured to pierce a wall of bodily tissue.

[0022] In some embodiments, the controller linkage includes a plurality of linkage arms coupled to move the grasper arms between the closed configuration and the open configuration.

[0023] According to other or additional aspects, the present disclosure is directed to a method of manipulating tissue with 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 of the distal tissue wall, actuating a tissue manipulation device controller to pivot at least one grasper arm relative to the tissue manipulation device controller and into an open configuration that engages distal of the distal tissue wall; and moving the tissue manipulation device proximally to move the distal tissue wall to be juxtaposed with the proximal tissue wall. In some embodiments, the tissue manipulation device includes a shaft and a tissue grasper assembly. In some embodiments, the tissue grasper assembly includes at least one movable grasper arm pivotably coupled to the shaft and in a closed configuration extending along the shaft when the tissue manipulation device is extended through the proximal tissue wall and the distal tissue wall.

[0024] 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 tissue wall and the distal tissue wall and piercing the proximal tissue wall and the distal tissue wall with the sharp element.

[0025] In some embodiments, the method further includes detaching the tissue grasper assembly from the shaft to deploy the tissue grasper assembly holding the proximal tissue wall and the distal tissue wall in apposition.

[0026] In some embodiments, the tissue grasper assembly includes a collar coupling the tissue grasper assembly to the shaft and a controller link coupling the tissue manipulator device controller to the at least one grasper arm, and the method further includes locking the controller link with the collar to maintain the tissue grasper assembly in a configuration grasping the proximal tissue wall and the distal tissue wall in apposition.

[0027] In some embodiments, the method further includes actuating the tissue manipulator device controller to pivot the at least one grasper arm into a closed configuration in which the at least one grasper arm engages the distal tissue wall to hold the distal tissue wall in place relative to the tissue grasper assembly when the tissue manipulator device is manipulated to move the distal tissue or to fix the distal tissue wall in place relative to the proximal tissue wall.

[0028] These and other features and advantages of the present disclosure will be apparent from the following detailed description, which, taken in conjunction with the accompanying drawings, illustrating by way of example the principles of the claimed application. While the following disclosure is presented in terms of aspects or embodiments, it should be appreciated that individual aspects can be claimed either alone or in combination with aspects and features of this or any other embodiment. BRIEF DESCRIPTION OF DRAWINGS

[0029] 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 drawn to scale. The drawings are provided exclusively for purposes of illustration and can show detail in exaggerated form that can be useful in understanding the principles of the application. For example, devices can be enlarged to make details discernible, but are intended to be scaled down relative to, for example, a working channel suitable for delivery of a catheter or endoscope. In the drawings, like or similar elements are denoted by like or similar reference numbers, and similar elements are generally denoted with different like reference numbers incremented by 100, redundant description being omitted. For the sake of clarity and conciseness, not every element of every embodiment is labeled in every drawing, nor is every element of every embodiment shown, where description is not needed to enable one of ordinary skill in the art to understand the present disclosure.

[0030] The detailed description will be better understood in conjunction with the appended drawings, wherein like numerals designate like elements, and in which:

[0031] Figure 1 is a schematic illustration of the human gastrointestinal system as an exemplary environment to which embodiments of the present disclosure can be applied or used or deployed.

[0032] Figure 2is a proximal face perspective view of a tissue manipulation device in a closed configuration for delivery to a treatment site formed in accordance with the principles of the present disclosure.

[0033] Figure 3 is a proximal face perspective view of a tissue manipulation device in an open configuration for manipulating tissue formed in accordance with the principles of the present disclosure.

[0034] Figure 4 is a cross-sectional view along line IV-IV in Figure 2 illustrating an example of a coupling between a gripper arm and a controller of a tissue manipulation device formed in accordance with the principles of the present disclosure, with the gripper arm and coupling in an open configuration.

[0035] Figure 5 is a cross-sectional view along line V-V in Figure 3 illustrating an example of a coupling between a gripper arm and a controller of a tissue manipulation device formed in accordance with the principles of the present disclosure, with the gripper arm and coupling in a closed configuration.

[0036] Figure 6 is an embodiment of a gripping section in accordance with the present disclosure.

[0037] Figures 7A-7D illustrates sequential positions of a tissue manipulation device formed in accordance with the principles of the present disclosure relative to tissue to be moved into apposition.

[0038] Figure 8A and 8B illustrates an example of further positions of the tissue manipulation device after the positions illustrated in Figure 7D

[0039] Figure 9 illustrates another example of further positions of the tissue manipulation device after the positions illustrated in Figure 7D

[0040] Figure 10 is a front view of one embodiment of a distal end of a tissue manipulation device formed to puncture tissue and with gripper arms in a closed position.

[0041] Figure 11A is a front and partial perspective view of an embodiment of a gripper arm of a tissue manipulation device formed in accordance with the principles of the present disclosure reinforcing tissue gripping and in an open position.

[0042] Figure 11B is a front view of an embodiment of a gripper arm of a tissue manipulation device formed in accordance with the principles of the present disclosure reinforcing tissue gripping and in a closed position.

[0043] Figures 12A-12D ​​is a sequential position of a tissue manipulation device according to the principles of the present disclosure relative to a tissue defect to be repaired, whose gripper arms form a Figure 11A and 11B .

[0044] Figure 13 is a cross-section of one embodiment of a controller according to the principles of the present disclosure. DETAILED DESCRIPTION

[0045] The following detailed description should be read with reference to the drawings in which detailed embodiments of the application are illustrated by way of example. It should be understood that the application is not limited to the particular embodiments described as such may, of course, vary. All devices and systems, as well as methods discussed herein, are examples of apparatus and / or systems and / or methods according to one or more principles of the present disclosure. Each example is provided by way of explanation of the application, not limitation, and is merely an example of apparatus and / or systems and / or methods according to the principles of the present disclosure. The description of the embodiments should be read in conjunction with the drawings attached hereto. It is to be understood that the foregoing description is exemplary of the application only and is

[0046] It can be appreciated that the present disclosure is set forth in different levels of detail in this application. In some instances, detail is provided that can not be necessary for the comprehension of the present disclosure by those having ordinary skill in the art. In other instances, detail is omitted so as not to obscure the disclosure in unnecessary detail. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the scope of the present disclosure beyond the appended claims and their equivalents. Unless defined otherwise, all technical and scientific terms and any acronyms used herein have the same meanings as commonly understood by one of ordinary skill in the art in the field of the present disclosure. In accordance with the present disclosure, all devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0047] As used herein, "proximal" refers to a direction or position, etc. that is closest to a user (medical professional or clinician or technician or operator or physician, etc., which terms are used interchangeably without intent to limit or otherwise) when using the device (e.g., introducing the device into a patient, or during implantation, positioning or delivery), and "distal" refers to a direction or position that is farthest from the user when using the device (e.g., introducing the device into a patient, or during implantation, positioning or delivery). "Longitudinal" refers to extending along a longer or greater dimension of an element. "Center" refers to at least substantially bisecting a central point, and with respect to an opening, "central axis" refers to a line that at least substantially bisects a central point of the opening, which "central axis" extends longitudinally along a length of the opening when the opening comprises, for example, a tubular element, passage or bore.

[0048] As will now be described with reference to the accompanying drawings, devices and systems and methods are disclosed herein for manipulating and / or approximating and / or holding tissue walls apposed at a treatment site. The medical devices, instruments, tools, etc. of the present disclosure are not limited and can include various medical devices for accessing body passageways, including, for example, duodenoscopes, catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, etc. It should be understood that references will be made herein to manipulating and / or other terms, such as grasping, holding, approximating, drawing, pulling, holding, etc., which terms can be used interchangeably herein without intent to limit. Tissue walls, such as, without limitation, organ or lumen walls, can be drawn near or onto another tissue wall, for example, to appose the tissue walls, such as to form an anastomosis. For example, the devices and systems can engage and draw a portion of a small intestine toward a stomach wall, such as by piercing the small intestine and stomach walls, and hold the lumens / tissues together. Such methods and devices can also be used for access to 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 gall bladder, as well as for vascular applications. Additionally, the two ends of a separated tissue wall can be drawn together to close a defect therebetween. It can be appreciated that the present disclosure should not be construed as limited to only such procedures or end results. Moreover, while reference is made to a treatment site, such reference is made for convenience only and is not intended to limit the scope of the present disclosure.

[0049] In accordance with various principles of the present disclosure, a distal end of a tissue manipulation device has an elongate member (e.g., a catheter, a shaft, etc.), referred to herein for simplicity as a shaft, without intending to be limiting, through which (or along which) 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 detachable from the shaft for deployment of a tissue grasper assembly (including the grasper arms) of the tissue manipulation device. The grasper arms are movable between a closed configuration within the shaft (generally within a lumen defined within the shaft and extending along the lumen and the longitudinal or axial direction of the shaft) and an open configuration in which the grasper arms are expanded or extended away from the shaft, such as into contact with a tissue wall. In some embodiments, the grasper arms are resiliently biased, such as to remain in the open configuration capable of engaging 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. In other embodiments, another element of the tissue manipulation device can hold the resiliently biased grasper arms in the open configuration.

[0050] 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, with the distal end of the controller coupled or engaged with the at least one grasper arm to control movement of the grasper arm as required or instructed by a procedure in which the tissue manipulation device is used. The proximal end of the controller can be engaged with, or coupled to, or otherwise associated with, a controller handle to facilitate actuation of the controller. Any of various control handles known in the art or known in the past can be used to manipulate the controller, e.g., via the proximal end thereof, without limiting the scope of the present disclosure to particular details of configuration.

[0051] The distal end of the controller can be configured to effect movement of the grasper arm in any of various ways. Various distal configurations of the controller, generally engaged or otherwise coupled or associated with the grasper arm (these terms are used interchangeably herein without intending to be limiting), can be interchanged with various proximal configurations of the controller via which the controller is actuated to manipulate or control or actuate the grasper arm (these terms are used interchangeably herein without intending to be limiting). In some embodiments, the grasper arm is coupled to the tissue manipulation device via a linkage arm. In some embodiments, the controller can be advanced distally or retracted proximally to manipulate the relative position of the grasper arm to move the grasper arm between the closed configuration and the open configuration.

[0052] In accordance with some embodiments disclosed herein, the grasper arms can be coupled to a tissue grasper assembly configured to be releasable from a shaft of the tissue manipulation device for deployment. The shaft can then be withdrawn, leaving the tissue grasper assembly approximated to the tissue juxtaposed to one another.

[0053] According to some embodiments disclosed herein, the distal end of a tissue manipulation device may be configured to allow it to penetrate the tissue wall to be manipulated. In some embodiments, the distal end of the tissue manipulation device has a pointed end, such as a needle or other sharp element, capable of piercing the tissue wall. In some embodiments, the pointed end may be associated with a shaft and / or a gripper arm.

[0054] Various features may be provided to facilitate gripping, holding, moving, etc. (these terms are used interchangeably herein and are not intended to be limiting) of tissue. According to some embodiments described herein, the shape of at least one gripper arm may be set and configured to enhance engagement and / or gripping of tissue. In some embodiments, the free end (e.g., distal end) of at least one gripper arm is shaped and configured to enhance engagement and / or gripping of tissue, such as by locking the tissue. In some embodiments, one or more tissue gripping features, such as hooks, are provided along one or both of the gripper arms between the attachment end of the gripper wall (the end connected to the remainder of the tissue manipulation device, such as the distal end of the gripper arm) and the free end.

[0055] Various embodiments of organizational manipulation devices, systems, and methods will now be described with reference to the examples illustrated in the accompanying drawings. References to “one embodiment,” “embodiment,” “some embodiments,” “other embodiments,” etc., throughout this specification indicate that one or more specific features, structures, and / or characteristics according to the principles of this disclosure may be included in that embodiment. However, such references do not necessarily imply that all embodiments include the specific features, structures, and / or characteristics, or that one embodiment includes all the features, structures, and / or characteristics. Some embodiments may include one or more such features, structures, and / or characteristics, in different combinations thereof. Furthermore, references to “one embodiment,” “embodiment,” “some embodiments,” “other embodiments,” etc., throughout this specification do not necessarily refer to the same embodiment, and individual or alternative embodiments are not necessarily mutually exclusive with other embodiments. When a particular feature, structure, and / or characteristic is described in relation to an embodiment, it should be understood that such features, structures, and / or characteristics may also be used in combination with other embodiments, whether explicitly described or not, unless explicitly stated to the contrary. It should be further understood that such features, structures, and / or characteristics may be used alone or present, or in various combinations thereof, to generate alternative embodiments considered part of this disclosure, as describing all the numerous possible combinations and sub-combinations of features, structures, and / or characteristics would be overly cumbersome. Furthermore, the various features, structures, and / or characteristics described may be exemplified by some embodiments but not by others. Similarly, various features, structures, and / or characteristics or requirements described may be features, structures, and / or characteristics or requirements of some embodiments but may not be features, structures, and / or characteristics or requirements of other embodiments. Therefore, the invention is not limited to the embodiments specifically described herein.

[0056] Turning now to the drawings, a tissue manipulation system 100 formed in accordance with the principles of the present disclosure is shown in a schematic view of a portion of the gastrointestinal system, for example between the stomach S and a portion of the small intestine SI, such as the jejunum J, to establish an anastomosis. It will be appreciated that the gastrointestinal system is merely one of several anatomical sites in which the tissue manipulation system 100 formed in accordance with the principles of the present disclosure can be used, and that the particular anatomical site does not affect the scope or limit the disclosed tissue manipulation system 100. The tissue manipulation system 100 can include a delivery device, such as a flexible elongate member 102, for example an endoscope, a cannula, a delivery shaft, or the like, (for convenience and without intending to be limiting, the term flexible elongate member is used herein to generally refer to the delivery device) having a working channel therethrough via which a tissue manipulation device 110 is directed 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 schematically) extends from the tissue grasper assembly 120 to a proximal end 103 of the tissue manipulation system 100 for a user (for example, a medical professional, such as a physician, technician, endoscopist, or the like, or an automated system or otherwise) to access and manipulate to control the tissue grasper assembly 120. The tissue manipulation device 110 can be arranged in relation 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 such that a proximal end 133 of the tissue manipulation device controller 130 is positioned at or along the proximal end 103 of the tissue manipulation system 100. A control handle 104 can be provided at the proximal end 103 of the tissue manipulation system 100 and can be associated with the tissue manipulation device controller 130 and / or the flexible elongate member 102 (any controller known or heretofore known in the art and not illustrated as not necessary for a complete understanding of the tissue manipulation device 110).

[0057] The tissue manipulation device 110 is configured to be delivered to the treatment site TS through the flexible elongate member 102 in accordance with techniques known or heretofore known to medical professionals to advance a device or system through a patient's anatomy to a treatment site TS. The distal end 111 of the tissue manipulation device 110 can have a cross section configured to readily pass through an opening through a tissue wall, such as Figure 2As shown in the diagram. For example, the distal end 111 of the tissue manipulation device 110 may be configured in a closed position with a generally blunt surface to facilitate passage through holes or channels designated for the tissue manipulation device 110 (e.g., created or generated by it for passage, as discussed further in detail below) without causing any unwanted damage (e.g., abrasions, lacerations, tears, etc.). In some embodiments, the tissue manipulation device 110 has a shaft 116 with a distal end 115 to which a tissue gripper assembly 120 is coupled, and the outer contour (e.g., cross-sectional shape) of the side (longitudinal / axial extension) of the tissue gripper assembly 120 substantially matches the outer contour (e.g., cross-sectional shape) of the side shaft 116 (longitudinal / axial extension). For example, if the shaft 116 has a generally circular cross-section, then the tissue gripper assembly 120 may have an outer surface recessed around the longitudinal axis LA of the shaft 116.

[0058] According to one aspect of the disclosure, the tissue gripper assembly 120 includes one or more gripper arms 122 movably coupled to a shaft 116. In some embodiments, the gripper arms 122 are pivotally coupled to the shaft 116 about a pivot PA. The gripper arms 122 are available from... Figure 2 The closed form moves or pivots to the open form, such as Figure 3 As shown, the gripper arm 122 is positioned away from or spaced apart from the shaft 116. In the open configuration, the gripper arm 122 is away from the shaft 116, the free end 121 of the gripper arm 122 (as used herein, a "free end" of an element refers to the end beyond which the element does not extend) is spaced apart from the shaft 116, and / or the shape of the gripper arm 122 itself is set and configured to present a gripper surface 125, the shape of which is set and configured to have sufficient gripper arm surface area to engage and manipulate tissue as needed. One or more gripper arms 122 are coupled to the shaft 116 via a gripper arm coupling 124, such as a pivot or other structure that allows relative movement (e.g., pivoting or rotation) of the gripper arm 122 relative to the shaft 116. In some embodiments, the tissue gripper assembly 120 includes a retaining ring 126 mounted on the distal end 115 of the shaft 116, via which the gripper arm 122 is coupled to the shaft 116. In some embodiments, a gripper arm connector 124 is disposed at the connecting end 123 of the gripper arm 122, spaced apart from the free end 121 of the gripper arm 122. In some embodiments, the gripper arm connecting end 123 is formed at the free end of the gripper arm 122 opposite to the free end 121. It will be understood that although the shown gripper arm 122 is connected to the proximal extending free end 121 and to the end 123 proximal to the free end 121, other configurations and orientations are within the scope of this disclosure.

[0059] The tissue manipulation device controller 130 is coupled to the gripper 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 user access to actuate the tissue manipulation device controller 130 to operate the gripper arm 122 as desired relative to the shaft 116. In some embodiments, the tissue manipulation device controller 130 is moved distally or proximally to actuate the gripper arm 122. However, other movements or controls of the tissue manipulation device controller 130 are within the scope of the present disclosure, with particular movements not being critical to the broad principles of the present disclosure.

[0060] The tissue manipulation device controller 130 can be coupled to the gripper arm 122 in a manner known in the art or known in the past, capable of transmitting desired control movements or actions from the tissue manipulation device controller 130 to the gripper arm 122. In some embodiments, such as shown in Figure 4 and Figure 5 The tissue manipulation device controller 130 can include a controller element 132, such as a wire, with a fitting 134 at a distal end 131 thereof configured to be coupled to the tissue gripper assembly 120 via a controller coupling 140 to actuate the gripper arm 122 via the controller coupling 140.

[0061] In one embodiment, as shown in Figure 4 and 5 The controller coupling 140 is in the form of a linkage arm 142a, 142b, 142c, 142d. The controller element 132 of the tissue manipulation device controller 130 can be coupled with the controller coupling 140, such as via the fitting 134 of the distal end 131 of the controller element 132, such as via the proximal ends 143a, 143b of the proximal linkage arms 142a, 142b of the controller coupling 140, such as via a pivotable or rotatable coupling (e.g., a pivot). The distal ends 141a, 141b of the proximal linkage arms 142a, 142b can be movably (e.g., pivotably or rotatably) to the proximal ends 143c, 143d of the distal linkage arms 142c, 142d. The distal ends 141c, 141d of the distal linkage arms 142c, 142d can be movably (e.g., pivotably or rotatably) to the coupling end 123 of the gripper arm 122, such as via the gripper arm coupling 124. With reference to the closed position shown in Figure 4 and the open position shown in Figure 5 It can be appreciated that movement of the tissue manipulation device controller 130 distally actuates the controller coupling 140 to move from the configuration shown in Figure 4 to the configuration shown in Figure 5the configurations shown in FIGS. 1-3. It will be appreciated that the linkage arms 142a, 142b, 142c, 142d move from a retracted configuration (when the tissue grasper assembly 120 is in the closed orientation of Figure 4 FIG. 1) to an extended configuration (when the tissue grasper assembly 120 is in the open orientation of Figure 5 FIG. 2), and in so extending, the linkage arms 142a, 142b, 142c, 142d move (e.g., by contact) the grasper arms 122 to move the grasper arms 122 from the closed orientation (adjacent or against or along the shaft 116) to the open orientation spaced apart from and / or extending away from the shaft 116. In some embodiments, as shown in Figure 6 FIG. 3 and described in further detail below, the tissue grasper assembly 120 can remain in place and the tissue manipulation device controller 130 detached therefrom. It will be appreciated that other configurations of the tissue manipulation device controller and controller coupling are within the scope and spirit of the present disclosure, and the operation and movement of the grasper arms are not limited by the particular configuration of the controller or controller coupling.

[0062] Figures 8A-8B FIGS. 1-3 illustrate examples of the manipulation and movement of the tissue manipulation device 110 formed in accordance with the principles of the present disclosure when used in accordance with certain aspects of the present disclosure. As shown in Figure 7A FIG. 1, the tissue manipulation device 110 has 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 lumen or cavity, 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 lumen or cavity), and the tissue manipulation device 110 is shown being advanced through a distal tissue wall DTW and into a distal body lumen or cavity. In Figure 7B FIG. 2, the tissue grasper assembly 120 shown is moved or has been moved to the open orientation (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, as shown in Figure 7C FIG. 3, to engage the distal tissue wall DTW. Optionally (as shown in Figure 7C FIG. 4), the grasper arms 122 of the tissue grasper assembly 120 can be moved to a closed or partially closed configuration, bringing the grasper surfaces 125 of the grasper arms 122 (which face the shaft 116 when the grasper arms 122 are in the closed configuration) closer to the shaft 116 to hold the distal tissue wall DTW between the grasper surfaces 125 and the shaft 116. However, if desired, the grasper arms 122 can remain in the open orientation. As shown in Figure 7D FIG. 5, the distal tissue wall DTW can then be manipulated as desired, such as proximally (e.g., the distal lumen can be moved proximally), and optionally, in juxtaposition with the proximal tissue wall PTW.

[0063] According to one aspect of the present disclosure, and asFigure 8A and 8B As shown, once the distal tissue wall (DTW) is moved to be juxtaposed with the proximal tissue wall (PTW), as Figure 8A As shown, the tissue gripper assembly 120 can be moved to disengage from the distal tissue wall DTW. The gripper arm 122 can return to a closed position and move proximally, such as away from the distal cavity, away from the treatment site TS. Figure 8B As shown, procedures such as removal from the body can be performed. Further surgical procedures can then be performed at the treatment site TS, as are known or previously known in the medical field.

[0064] According to one aspect of this disclosure, and as Figure 9 As shown, once the distal tissue wall DTW is moved to be juxtaposed with the proximal tissue wall PTW, for example in Figure 7D After the position shown, shaft 116 can be separated / disengaged from tissue gripper assembly 120. Therefore, tissue gripper assembly 120 is left in place, securing the proximal tissue wall (PTW) and distal tissue wall (DTW) together to allow for further surgical procedures or to reinforce the fixation of tissue held together by a scaffold or other means in the treatment site (TS) area. Figure 9 In the example shown, the gripper arm 122 is in a closed configuration that holds the distal tissue wall DTW between the gripper arm 122 and the retainer ring 126 of the tissue gripper assembly 120. However, alternative configurations that allow the gripper arm 122 to remain in an open configuration abutting the distal tissue wall DTW are within the scope and spirit of this disclosure.

[0065] Based on the principles of this disclosure, any of a variety of locking features can be provided to retain the gripper arm 122 in place after the shaft 116 has been disengaged (as in...). Figure 9 (The closed configuration shown, or the open / expanded configuration). In one embodiment, such as... Figure 6 As shown (briefly mentioned above), the tissue gripper assembly 120 may include a locking feature 128 configured to engage or interlock the proximal end 143 of the fitting 134 and / or controller coupling 140 on the tissue manipulation device controller 130 with or interlock with the retaining ring 126. The tissue manipulation device controller 130 may be actuated (e.g., moved proximally and / or rotated or otherwise moved relative to the retaining ring 126) to engage or actuate the locking feature 128 to retain the tissue gripper assembly 120 in a closed configuration. In one embodiment, as Figure 6In the example shown, the form of the locking feature is an inwardly directed flange 127 on the collar 126 and a corresponding flange 137 on the fitting 134. The fitting flange 137 can be sized to be slightly wider in width than the collar flange 127 and resiliently flexible such that the fitting flange 137 extends over and through the collar flange 127, the fitting flange 137 held in place proximal of the collar flange 127. In some embodiments, the fitting flange 137 is defined by a distally extending groove 139 around the periphery of the fitting 134, such that proximal and distal movement of the fitting 134 and the controller link 140 is limited by the collar flange 127 engaged within the groove 139. It will be appreciated that other arrangements, such as retaining the gripper arms 122 in an open configuration, are within the scope of the present disclosure. Once the controller link 140 is held in the desired position to retain the gripper arms 122 in the desired configuration, the tissue manipulation device controller 130 can be decoupled (e.g., broken) from the controller link 140, and the shaft 116 can be decoupled from the controller link 140, as shown, leaving the controller link 140 in place to retain the desired relative position (e.g., apposition) of the distal tissue wall DTW and the proximal tissue wall PTW. Various configurations and decoupling methods of such components known or heretofore known in the art can be used without affecting the scope of the present disclosure.

[0066] Referring again to Figure 7A Prior to inserting the tissue gripper assembly 120 through the tissue wall, an opening through the tissue wall can be pre-formed on the tissue wall (e.g., by a separate cutting instrument), through which the gripper assembly 120 is passed. In some embodiments, to facilitate the tissue manipulation process, such as by reducing the number of procedures and / or necessary instruments or devices, the tissue gripper assembly 120 can be configured to pierce the tissue wall and then pass therethrough. In some embodiments, the tissue gripper assembly 120 can be provided with a sharp distal end extending distally from the tissue gripper assembly 120. In one embodiment, as shown in FIG. 1 1, the tissue gripper assembly 120 can be provided with a sharp distal end 128 extending distally from the tissue gripper assembly 120. In some embodiments, the sharp distal end 128 can be configured to pierce the tissue wall and then pass therethrough. Figure 10As shown, a sharp element 150, such as a needle, can be formed or provided at the distal end 121 of the tissue grasper assembly 120 (e.g., on the distal end of the collar 126, if present, 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 to allow passage of the tissue grasper assembly 120 therethrough. As can be appreciated, the grasper arms 122 preferably remain in the closed configuration as shown when the sharp element 150 pierces the tissue wall. The tissue manipulation device 110 can be further advanced to advance the sharp element 150 of the distal end 151 of the tissue grasper assembly 120 toward another tissue wall to pierce the other tissue wall to allow passage of the tissue grasper assembly 120 therethrough as well. Further manipulation of the tissue manipulation device 110 can be performed, such as Figure 7B 、 7C , any of 7D, 8A, 8B, 9 as shown.

[0067] Referring again to Figure 7C , in some embodiments, it can be desirable to provide grasping features on the grasper arms 122 to facilitate grasping, gripping, moving, etc. of tissue. In one embodiment, as shown in Figure 11A and 11B , the free ends 121 of one or more of the grasper arms 122 can be provided with tissue grasping features 160, such as barbs or hooks or claws or other tissue-engaging protrusions. Additionally, or alternatively, one or more grasping features 160 can be provided along the grasper surfaces 125 between the free ends 121 and the coupled ends 123 of the grasper arms 122. The tissue grasping features 160 are configured to enhance grasping (e.g., locking) of tissue so that the grasper arms 122 do not inadvertently move relative to a manipulated tissue wall or relative to a tissue wall held in place by the tissue grasper assembly 120 that is deployed and left in place to perform such a function (e.g., as described above with reference to Figure 9 . In accordance with some aspects of the present disclosure, the grasping features 160 can be used to facilitate repair of a defect using the tissue grasper assembly 120, as will now be described.

[0068] As can be appreciated, in accordance with the principles of the present disclosure, the tissue manipulation device 110 can be used for a variety of procedures other than drawing and / or holding tissue walls of different organs or cavities together. For example, as shown in Figures 12A-12D , the tissue manipulation device 110 can be used to repair a defect, such as by drawing tissue walls of different sides or edges of the defect together. As shown in Figure 12AAs shown, the tissue grasper assembly 120 can be advanced to the tissue defect TD, one of the grasper arms 122 can be engaged with the tissue wall along one side or edge of the tissue defect TD, for example by the grasping features 160 of the grasper arm 122 engaging the tissue. In Figure 12A the illustration, the grasper arms 122 are in an open configuration to facilitate engagement of a portion of the grasper arms 122, such as the distal end 121 of the grasper arms 122, the grasper surface 125 of the grasper arms 122, the grasping features 160 of the grasper arms 122, etc., with the tissue. The grasper arms 122 are then moved to a closed configuration, as shown in Figure 12B the illustration, to maintain the relative position and grasp of the tissue grasper assembly 120 and the grasped tissue region. The tissue grasper assembly 120 is then moved across the defect with the grasped tissue, and the other grasper arm 122 is extended to engage another region of the tissue wall along the tissue defect TD, such as the tissue wall on the other side of the tissue defect TD from the initially grasped tissue wall segment, as shown in Figure 12C the illustration. The grasping features 160 of the grasper arms 122 engage the initially grasped tissue region to facilitate maintenance of the grasper arms 122 hold on the initially grasped tissue region even as the grasper arms 122 are moved to an open configuration. The grasper arms 122, at least two of which are engaged with the tissue around the tissue defect TD, can then be moved to a closed configuration, as shown in Figure 12D the illustration, to effect closure of the defect. The tissue grasper assembly 120 can remain in place in the closed configuration to appose the tissue wall and reduce the size of the tissue defect TD to allow the defect to heal. It can be appreciated that the grasping features 160 can facilitate maintenance of the tissue grasper assembly 120 on the tissue throughout the repair process.

[0069] To facilitate procedures, such as tissue repair, in which it can be desirable for one grasper arm 122 to be in a closed configuration while the other grasper arm 122 is in an open configuration, independent operation of the grasper arms 122 can be desirable so that each grasper arm 122 can be independently moved between the open and closed configurations. It can be appreciated that independent operation of the grasper arms 122 can facilitate tissue repair without the assistance of the grasping features 160 on the grasper arms 122 because the initially grasped tissue region can be sufficiently or adequately grasped by the tissue grasper assembly 120 by closing the grasper arm 122 to engage such initially grasped tissue region.

[0070] Figure 13 Examples of tissue manipulation device controllers 130 and controller links 140 that allow independent movement of the grasper arms 122 are described in the background. As shown, the tissue manipulation device controller 130 includes one or more controller elements 132, each of which is engaged with a different grasper arm 122. Operation of the controller elements 132 and the controller links 140 can be similar toFigure 4 and Figure 5 Embodiments of the following description and reference thereto can be understood. It will be appreciated that other configurations are within the scope of the present disclosure.

[0071] In view of the foregoing 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 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 form one anastomosis, for example, between two portions of the intestinal tract. An endoscope-based device can be used to form an anastomosis between a gastric fundus pouch and a portion of the intestinal tract, such as the jejunum. Combinations of laparoscope-based devices and catheter devices described herein can also be used to form a single anastomosis.

[0072] The above discussion is meant to be illustrative and is presented for purposes of illustration and description. It is not intended to exclude implementations of the present disclosure that do not fall within the present disclosure. It is to be understood that various substitutions, modifications and alterations can be made to the embodiments disclosed herein without deviating from the concepts, spirit and scope of the present disclosure. In particular, the principles of the present disclosure can be embodied in other forms, structures, arrangements, proportions and with other elements, materials and components, without departing from the principles, spirit or scope of the present disclosure or the features thereof. For example, various features of the present disclosure are combined in one or more aspects, embodiments or configurations for simplicity of disclosure. It should be understood, however, that the various features of the aspects, embodiments or configurations of the present disclosure can be combined in other aspects, embodiments or configurations. While the present disclosure is presented in terms of embodiments, it should be appreciated that not all individual features of the present subject matter are necessarily required for achieving at least some of the desirable features and / or benefits of the present subject matter or such individual features. Those skilled in the art will appreciate that many modifications or variations to the structures, arrangements, proportions, materials, elements, and other aspects described herein can be made without departing from the principles or spirit of the present disclosure or the scope of the present disclosure. For example, elements shown as integrally formed can be constructed of multiple parts, or elements shown as multiple parts can be integrally formed, the operation can be reversed or otherwise varied, the size or dimensions of the elements can be varied. Also, while operations or actions or procedures are described in particular orders, this should not be understood as requiring such particular orders, or that all operations or actions or procedures be performed, to achieve desirable results. Further, other embodiments 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 desirable results. Accordingly, the presently disclosed embodiments are to be considered in all respects as illustrative and not restrictive, the scope of the subject matter being indicated by the appended claims rather than the description contained herein or the particular embodiments or arrangements described or illustrated herein. In view of the foregoing, individual features of any embodiment can be used and claimed separately or in combination with features of that embodiment or any other embodiment, the scope of the subject matter being indicated by the appended claims rather than the description contained herein or the particular embodiments or arrangements described or illustrated herein.

[0073] In the above description and the following claims, the following will be understood. The phrases "at least one", "one or more", and "and / or" as used herein are open-ended expressions that are both conjunctive and disjunctive in operation. The expression "a", "an" and "the" preceding an element do not, unless the context dictates otherwise, exclude a plurality of the elements. For example, as used herein, the expression "a", "an" and "the" is intended to cover any one of the elements or a plurality of the elements. Thus, "a", "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, anterior, posterior, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are used for identification purposes only and do not necessarily indicate the relative position to one another of the elements referenced. Similarly, connections between elements are not limited to direct connections but include indirect connections unless otherwise specified. Thus, connections references (e.g., connected, coupled, joined, and joined with) should be construed in context and are used to aid the reader in understanding the embodiments, and are not necessarily intended to limit the scope of the disclosure to the described connections. Identifying references (e.g., primary, secondary, first, second, third, fourth, etc.) are not meant to be limiting, but are used to distinguish one feature from another. The following claims are hereby incorporated into this detailed description by reference, each claim as a separate embodiment of the disclosure. The reference signs in the claims are provided purely for explanatory purposes and shall not be construed as limiting the scope of the claims in any way.

[0074] The following claims are hereby incorporated into this detailed description by reference, each claim as a separate embodiment of the disclosure. In the claims, the term "comprising" does not exclude other elements or steps. Also, the use of the term "a" or "an" does not exclude a plurality. The recitation of multiple elements in a claim does not preclude there from being additional such elements. The reference signs in the claims shall not be construed as limiting the scope of the claims in any way.

Claims

1. An organization manipulation device, comprising: axis; A tissue gripper assembly, the tissue gripper assembly being coupled to the distal end of the axis and including one or more gripper arms, the one or more gripper arms being movable between a closed configuration extending along the axis and an open configuration extending away from the axis; as well as A controller, which is coupled to the tissue gripper assembly and configured to move the gripper arm between the closed state and the open state; At least one of the gripper arms has a gripper surface that is shaped and configured to engage body tissue; The one or more gripper arms of the tissue gripper assembly are configured to move toward the closed configuration such that the gripper surface facing the axis is closer to the axis when the gripper arm is in the closed configuration than when it is in the open configuration, thereby holding body tissue between the gripper surface and the axis; and Each of the gripper arms has a connecting end and a free end, and at least one of the gripper arms includes a gripping feature disposed between the free end of the gripper arm and / or the connecting end and the free end of the gripper arm to facilitate gripping body tissue.

2. The tissue manipulation device of claim 1, wherein the gripper arm is pivotally coupled to the shaft.

3. The tissue manipulation device of claim 1 or 2, wherein the tissue gripper assembly is detachable from the axis and the controller to maintain the deployed gripping of body tissue.

4. The tissue manipulation device according to any one of claims 1-3, wherein the tissue gripper assembly includes a locking feature that engages when the tissue gripper assembly is separated from the shaft and the controller to hold the at least one gripper arm in one of a closed or open configuration.

5. The tissue manipulation device according to any one of claims 1-4, further comprising a controller coupling connected between the gripper arm and the controller, and movable when the controller is actuated to move the at least one gripper arm between the closed state and the open state.

6. The tissue manipulation device of claim 5, wherein the tissue gripper assembly further includes a retaining ring coupled to the shaft, the gripper arm being coupled to the shaft via the retaining ring.

7. The tissue manipulation device of claim 6, wherein the retaining ring and the controller coupling include mutually engaging locking features configured to hold the controller coupling in place to retain the at least one gripper arm in the closed configuration.

8. The tissue manipulation device according to any one of claims 1-7, further comprising a controller coupling connected between the gripper arm and the controller, and movable upon actuation of the controller to move the at least one gripper arm between the closed state and the open state.

9. The tissue manipulation device of claim 8, wherein the controller coupling includes a plurality of linked arms coupled to move the gripper arm between the closed state and the open state.

10. The tissue manipulation device of claim 8, wherein the controller coupling comprises at least two controller elements, the two controller elements being coupled to their respective first gripper arm and second gripper arm to independently control the first gripper arm and the second gripper arm.

11. A tissue gripper assembly, the tissue gripper assembly comprising: A retaining ring, which is configured for connection with the distal end of a shaft; One or more gripper arms, the one or more gripper arms being pivotally connected to the clasp, each gripper arm having a gripper surface shaped and configured to engage with body tissue; as well as A controller connector is coupled to at least one of the gripper arms and is movable to move the at least one gripper arm between a closed configuration extending along the retaining ring and an open configuration extending away from the retaining ring. In the closed configuration, the gripper surface is configured to hold body tissue between the gripper surface and the retaining ring; and Each of the gripper arms has a connecting end that connects to the retaining ring and a free end that extends away from the retaining ring, and at least one gripper arm includes a gripping feature disposed between the free end of the gripper arm and / or between the connecting end and the free end of the gripper arm to facilitate gripping body tissue.

12. The tissue gripper of claim 11, wherein the retainer ring and the gripper arm have matching outer surface profiles to provide a low-profile profile to the tissue gripper assembly when the gripper arm is in the closed configuration.

13. The tissue gripper of any one of claims 11-12, further comprising a sharp element extending distally from the tissue gripper assembly and configured to pierce the body tissue wall.

14. The tissue gripper of any one of claims 11-13, wherein the controller coupling includes a plurality of linked arms coupled to move the gripper arm between the closed state and the open state.

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