Gripping system and method for lumen adhesions or wound defects

Abstract

A tissue manipulation system includes a tissue manipulation device having a shaft and a tissue gripper assembly. The tissue gripper assembly has at least one gripper arm resiliently expandable from a closed configuration to an open configuration outside the shaft, wherein in the closed configuration the at least one gripper arm is within the shaft and extends along the longitudinal axis of the shaft, and in the open configuration the at least one gripper arm expands transversely to the longitudinal axis of the shaft. In the open configuration, the at least one gripper arm can engage with a tissue wall to manipulate or move the tissue wall, for example, moving a distal tissue wall closer to a proximal tissue wall. The tissue gripper assembly can be deployable (e.g., by being detached from the shaft), for example, held in place to maintain two tissue walls juxtaposed.

Description

[0001] priority

[0002] Pursuant to 35 USC §119, this application claims priority to U.S. Provisional Patent Application No. 63 / 073,192, filed September 1, 2020, the disclosure of which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This disclosure generally relates to apparatus and methods for manipulating tissue walls and / or bringing tissue walls close to and / or maintaining tissue walls in juxtaposition. Background Technology

[0004] Tissue retrieval techniques are useful in many medical procedures for a variety of purposes. Many medical procedures require moving tissue walls (e.g., lumen walls or organ walls) to desired locations, such as associating them with another tissue wall, to create an anastomosis between adjacent lumens or to repair body tissue. Moving one lumen towards another and securing the two lumens in place presents challenges.

[0005] Therefore, improved tools, devices, systems, and methods for manipulating and moving bodily organs, tissues, lumens, etc., will be welcomed in the medical field. Summary of the Invention

[0006] The summary of this disclosure is provided to aid understanding, and those skilled in the art will understand that each of the aspects and features of this disclosure may be used advantageously alone in some cases, or in combination with other aspects and features disclosed in this disclosure in others. The inclusion or exclusion of elements, components, etc., in the content of this invention is not intended to limit the scope of the claimed subject matter.

[0007] This disclosure relates to a tissue manipulation device and system capable of manipulating, grasping, holding, pulling, dragging, pulling, holding (such terms are used interchangeably herein and are not intended to be limiting) tissue walls, etc. Optionally, the device and system can be used to hold tissues together and juxtapose them. Improved protocols and pathways, as well as tissue grasping / tissue gripping tools, devices, and systems, are desired for pulling tissues together, for example, for forming anastomoses or repairing tissues. Protocols, tools, devices, and systems that facilitate faster anastomosis formation are also desired. Protocols, tools, devices, and systems for holding tissues juxtaposed are also desired (e.g., while simultaneously minimizing any risk of leakage between tissues).

[0008] In one aspect, this disclosure relates to a tissue manipulation device comprising a shaft having a longitudinal axis, a tissue gripper assembly, and a controller. In some embodiments, the tissue gripper assembly includes one or more resilient gripper arms that expand between a closed configuration and an open configuration outside the shaft, wherein in the closed configuration, the one or more resilient gripper arms are internal to the shaft and extend along the longitudinal axis of the shaft, and in the open configuration, the one or more resilient gripper arms extend laterally away from the longitudinal axis of the shaft. In some embodiments, a gripper surface is associated with at least one of the gripper arms and is shaped and configured to engage body tissue. In some embodiments, when at least one gripper arm is in the open configuration and the gripper surface contacts the body tissue and the tissue manipulation device moves proximally, the tissue manipulation device also moves the body tissue proximally. In some embodiments, the controller is coupled to the tissue gripper assembly via a controller connector and is configured to move the gripper arms between the closed and open configurations.

[0009] In some embodiments, when the gripper arm is positioned outside the shaft, the gripper arm is resiliently biased into an open configuration in a radially outward direction away from the shaft.

[0010] In some embodiments, the gripper arm is elastically held in an open configuration by a steering feature formed on the distal end of the shaft.

[0011] In some embodiments, the tissue gripper assembly is detachable from the axis and controller to maintain deployed gripping of body tissue. In some additional embodiments, the tissue gripper assembly includes a locking feature that engages to retain at least one gripper arm engaging tissue when the tissue gripper assembly is detached from the axis and controller. In some additional or alternative embodiments, the tissue manipulation device further includes a controller connector coupled between the gripper arm and the controller, and movable upon actuation of the controller to move at least one gripper arm between a closed configuration and an open configuration, the controller being detachable from the controller connector to deploy the tissue gripper assembly. In some alternative or additional embodiments, the tissue gripper assembly also includes a capsule connected to the axis, the gripper arm being connected to the axis via the capsule, the tissue gripper assembly being detachable from the capsule from the axis and controller to maintain deployment for gripping body tissue.

[0012] In some embodiments, at least one of the gripper arms includes a proximal axial tissue gripping feature when the gripper arm extends distally beyond the axis and expands into an open configuration.

[0013] In some embodiments, the tissue manipulation device further includes a sharp element extending distally from the distal end of the tissue gripper assembly and configured to pierce the body tissue wall.

[0014] In some embodiments, the gripper arm is in the form of an elastic bias line, and the gripper surface is disposed on a tissue holding feature associated with the gripper arm.

[0015] According to other aspects, this disclosure relates to a tissue gripper assembly comprising a capsule having a longitudinal axis, one or more resilient gripper arms, and a controller connector. In some embodiments, the one or more gripper arms are expandable between a closed configuration and an open configuration outside the capsule, wherein in the closed configuration, the one or more gripper arms are within the capsule and extend along the longitudinal axis of the capsule, and in the open configuration, the one or more gripper arms extend laterally away from the longitudinal axis of the capsule. In some embodiments, a gripper surface is associated with at least one of the gripper arms and is shaped and configured to engage body tissue. In some embodiments, the controller connector is coupled to at least one of the gripper arms and is movable to move at least one gripper arm between the closed and open configurations.

[0016] In some embodiments, the tissue gripper assembly further includes a locking feature that can be engaged to retain the tissue gripper assembly in a configuration that engages the tissue.

[0017] In some embodiments, the capsule is configured for connection to the distal end of the shaft.

[0018] In some embodiments, the capsule has a proximal end and a distal end, and one or more gripper arms extend from each of the proximal and distal ends of the capsule.

[0019] In some embodiments, the tissue gripper assembly further includes a sharp element extending distally from the tissue gripper assembly and configured to pierce the body tissue wall.

[0020] In some embodiments, at least one of the gripper arms is elastically held in an open configuration by a steering feature formed on the distal end of the shaft.

[0021] In some embodiments, one or more of the gripper arms have tissue gripping features configured to engage tissues.

[0022] According to other aspects, this disclosure relates to a method of manipulating tissue with a tissue manipulation device, the method comprising extending the tissue manipulation device through a distal tissue wall to move a distal end of the tissue manipulation device to a distal side of the distal tissue wall, the tissue manipulation device including a shaft having a longitudinal axis and a tissue gripper assembly; actuating a tissue manipulation device controller; and proximally moving the tissue manipulation device to proximally move the distal tissue wall. In some embodiments, when the tissue manipulation device is extended through the distal tissue wall, the tissue gripper assembly includes at least one resiliently extendable gripper arm in a closed configuration, the gripper arm being within and extending along the shaft. In some embodiments, actuating the tissue manipulation device controller includes extending at least one resiliently extendable gripper arm from inside the shaft to outside the shaft to allow at least one resiliently extendable gripper arm to expand into an open configuration extending transversely to the longitudinal axis of the shaft. In some embodiments, proximally moving the tissue manipulation device engages at least one gripper arm with the distal tissue wall and proximally moves the distal tissue wall.

[0023] In some embodiments, the method further includes extending the tissue manipulation device through the proximal tissue wall before extending the tissue manipulation device through the distal tissue wall, and moving the tissue manipulation device proximally to juxtapose the distal tissue wall with the proximal tissue wall.

[0024] In some embodiments, the method further includes separating the tissue gripper assembly from the axis to deploy the tissue gripper assembly that holds the proximal and distal tissue walls juxtaposed.

[0025] These and other features and advantages of this disclosure will become apparent from the following detailed description, the scope of which is set forth in the appended claims. While the following disclosure is presented by way of aspect or embodiment, it should be understood that individual aspects may be claimed alone or in combination with aspects and features of that embodiment or any other embodiment. Attached Figure Description

[0026] Non-limiting embodiments of the present disclosure have been 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 for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected in the figures may vary. For example, devices may be enlarged to make details discernible, but are intended to be scaled down relative to, for example, when mounted within the working channel of a delivery catheter or endoscope. In the drawings, identical or substantially identical or equivalent elements are generally denoted by the same reference numerals, and similar elements are generally denoted by different similar reference numerals in increments of 100, and repetitive descriptions are omitted. For purposes of clarity and simplicity, where no description is required to enable those skilled in the art to understand the present disclosure, not every element in each drawing is labeled, nor is every element of each embodiment shown.

[0027] The detailed description will be better understood in conjunction with the accompanying drawings, in which the same reference numerals denote the same elements, as follows:

[0028] Figure 1 The illustration depicts the human gastrointestinal system as an example environment in which embodiments of this disclosure may be applied, used, or deployed.

[0029] Figure 2A It is a front view of a tissue manipulation device formed according to the principles of this disclosure, and is shown in a closed configuration for delivery to the treatment site.

[0030] Figure 2B yes Figure 2A End view of the organization's manipulation device.

[0031] Figure 2C Is it like this? Figure 2A The diagram shows a front view of the tissue manipulation device in an open configuration for manipulating tissue.

[0032] Figure 2D This is a front view of another embodiment of an organization manipulation device in a closed configuration according to the present disclosure.

[0033] Figure 2E It is in the open configuration. Figure 2D A front view of the organization's manipulation device.

[0034] Figure 3A It is a perspective view of another tissue manipulation device formed according to the principles of this disclosure, and is shown in a closed configuration for delivery to the treatment site.

[0035] Figure 3B Is it like this? Figure 3A The diagram shows a perspective view of the tissue manipulation device in an open configuration for manipulating tissue.

[0036] Figures 4A-4D The diagram illustrates a tissue manipulation device formed according to the principles of this disclosure, relative to the sequential positions of the tissues to be moved to.

[0037] Figures 5A-5C The tissue manipulation device is shown to reach, such as Figure 4D Examples of other locations following the position shown.

[0038] Figures 6A-6C The sequential position of the tissue manipulation device formed according to the principles of this disclosure relative to the tissue defect to be repaired according to the principles of this disclosure is shown.

[0039] Figure 7A It is a front view of a tissue manipulation device formed according to the principles of this disclosure, and is shown in a closed configuration for delivery to the treatment site.

[0040] Figure 7B yes Figure 7A End view of the organization's manipulation device.

[0041] Figure 7C Is it like this? Figure 7A or Figure 7B The organization manipulation device is shown in the front view of the open configuration for manipulating the organization.

[0042] Figure 8A It is a front view of a tissue manipulation device formed according to the principles of this disclosure, and is shown in a closed configuration for delivery to the treatment site.

[0043] Figure 8B yes Figure 8A End view of the organization's manipulation device.

[0044] Figure 8C Is it like this? Figure 8A or Figure 8B The diagram shows a front view of the tissue manipulation device in an open configuration for manipulating tissue.

[0045] Figure 9A It is a front view of a tissue manipulation device formed according to the principles of this disclosure, and is shown in a closed configuration for delivery to the treatment site.

[0046] Figure 9B Is it like this? Figure 9A The diagram shows a front view of the tissue manipulation device in an open configuration for manipulating tissue.

[0047] Figure 9C Is it like this? Figure 9A or Figure 9B The perspective view of the organization manipulation device in the open configuration for manipulating the organization.

[0048] Figure 10A It is a front view of a tissue manipulation device formed according to the principles of this disclosure, and is shown in a closed configuration for delivery to the treatment site.

[0049] Figure 10B Is it like this? Figure 10A The diagram shows a front view of the tissue manipulation device in an open configuration for manipulating tissue.

[0050] Figure 10C Is it like this? Figure 10A or Figure 10B The perspective view of the organization manipulation device in the open configuration for manipulating the organization.

[0051] Figure 11A It is a perspective view of a tissue manipulation device formed according to the principles of this disclosure, and is shown in a closed configuration for delivery to the treatment site.

[0052] Figure 11B Is it like this? Figure 11A The diagram shows a perspective view of the tissue manipulation device in an open configuration for manipulating tissue.

[0053] Figure 12A It is a front view of a tissue manipulation device formed according to the principles of this disclosure, and is shown in a closed configuration for delivery to the treatment site.

[0054] Figure 12B Is it like this? Figure 12A The diagram shows a front view of the tissue manipulation device in an open configuration for manipulating tissue.

[0055] Figure 13A It is a front view of an organization manipulation device formed according to the principles of this disclosure relative to an organization pulled together according to the principles of this disclosure.

[0056] Figure 13B Is it like this? Figure 13A The diagram shows a front view of a tissue manipulation device that pulls tissue walls together.

[0057] Figure 14 This is a front view of an organization manipulation device formed in accordance with the principles of this disclosure.

[0058] Figure 15 Is it possible to... Figure 14 A cross-sectional view of the locking cap used in conjunction with the organization's manipulation device.

[0059] Figure 16 As shown Figure 15 The tissue manipulation device shown is positioned to repair tissue defects.

[0060] Figure 17 As shown Figure 15 The tissue manipulation device shown is positioned to hold the tissue in a juxtaposed position.

[0061] Figure 18 It is a cross-sectional view of an organization manipulation device formed according to the principles of this disclosure.

[0062] Figures 19A-19E The following is illustrated based on the principles of this disclosure: Figure 18 The tissue manipulation device is shown in sequence relative to the tissue defect to be repaired.

[0063] Figures 20A-20C The diagram illustrates a tissue manipulation device formed according to the principles of this disclosure, relative to the sequential positions of the tissues to be moved to. Specific Implementation

[0064] The following detailed description should be read with reference to the accompanying drawings, which depict illustrative embodiments. It should be understood that this disclosure is not limited to the specific embodiments described, as they can vary. All apparatuses, systems, and methods discussed herein are examples of apparatuses and / or systems and / or methods implemented according to one or more principles of this disclosure. Each example of an embodiment is provided in an illustrative manner and is not the only way to implement these principles but is merely an example. Therefore, references to elements or structures or features in the drawings must be understood as references to examples of embodiments of this disclosure and should not be construed as limiting this disclosure to the specific elements, structures, or features shown. Other examples of ways of implementing the disclosed principles will conceive of those skilled in the art upon reading this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made to this disclosure without departing from the scope or spirit of the subject matter. For example, features shown or described as part of one embodiment may be used with another embodiment to produce yet another embodiment. Therefore, this subject matter is intended to cover such modifications and variations falling within the scope of the appended claims and their equivalents.

[0065] It should be understood that this disclosure is set forth in varying degrees of detail in this application. In some cases, details that are not necessary for those skilled in the art to understand this disclosure, or details that make other details difficult to perceive, may have been omitted. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope beyond the appended claims. Unless otherwise defined, the technical terms used herein should be understood as commonly understood by those skilled in the art to which this disclosure pertains. Based on this disclosure, all the apparatuses and / or methods disclosed and claimed herein can be made and performed without excessive experimentation.

[0066] As used herein, “proximal” refers to the direction or position closest to the user (medical specialist, clinician, technician, operator, or physician, etc., such terms are used interchangeably and are not intended to be limiting), for example, when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery). “Distal” refers to the direction or position furthest from the user, for example, when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery). “Longitudinal” refers to extending along the longer or larger dimension of the element. “Center” refers to at least substantially bisecting a central point, while “central axis” refers to a line that, relative to an opening, at least substantially bisects the center point of that opening, extending longitudinally along the length of the opening when the opening includes, for example, a tubular element, channel, or aperture.

[0067] As will now be described with reference to the accompanying drawings, this document discloses apparatus, systems, and methods for manipulating tissue walls and / or pulling tissue walls closer together and / or maintaining tissue walls juxtaposed at a treatment site. The medical devices, instruments, tools, etc., disclosed herein are not limited and may include a variety of medical devices for accessing body passages, including, for example, duodenoscopes, catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, etc. It should be understood that reference will be made herein to terms such as manipulation and / or other terms, such as grasping, holding, pulling closer, traction, traction, holding, etc., which are used interchangeably herein and are not intended to be limiting. Tissue walls, such as, but not limited to, organ or lumen walls, may be pulled closer to or toward another tissue wall, for example, to maintain tissue wall juxtaposition, for example, to form an anastomosis. For example, the apparatus and system may, for example, engage a portion of the small intestine by puncturing the wall of the small intestine and pulling it toward the stomach wall, and holding the lumen / tissue together. Such methods and apparatus can also be used for entry into and exit from the urinary tract (e.g., bladder and ureters), lungs (e.g., trachea and bronchi), and biliary tracts (e.g., bile ducts and gallbladder), as well as for vascular applications. Alternatively, the separated ends of tissue walls can be pulled together to close defects therebetween. It should be understood that this disclosure should not be construed as limiting oneself to such procedures or end results. Furthermore, while treatment sites are mentioned, such references are merely for convenience and not for limiting the scope of this disclosure.

[0068] According to various principles of this disclosure, the distal end of a tissue manipulation device has an elongated member that is generally hollow, such as a catheter, cannula, hollow shaft, etc. (referred to herein as a shaft for simplicity and not for limitation), through which one or more gripper arms may extend. In some embodiments, the shaft is in the form of a collar or capsule. In some embodiments, the shaft includes a collar or capsule (such terms are used interchangeably herein and are not intended to be limiting) formed separately from and connected to the shaft, and optionally removed from the shaft to deploy the tissue gripper assembly (including gripper arms) of the tissue manipulation device. The gripper arms are movable between a closed configuration within the shaft (generally within a lumen defined within the shaft and extending along the longitudinal or axial range of the lumen and the shaft) and an open configuration in which the gripper arms unfold or extend away (e.g., engage tissue walls). In some embodiments, the gripper arms are resiliently biased, for example, held in an open configuration capable of engaging tissue. In some embodiments, the gripper arms are resiliently biased to expand or otherwise extend into an open configuration upon release from or deployment from the shaft. In other embodiments, another element of the tissue manipulation device may hold the resiliently biased gripper arm in an open configuration.

[0069] The tissue manipulation device can advance to the treatment site via the working channel of a delivery device, such as a flexible elongated member of a tissue manipulation system (e.g., a catheter, endoscope, cannula, delivery shaft, etc.; for convenience and not limitation, the term "flexible elongated member" generally refers to the delivery device). A gripper arm can be controlled by a tissue manipulation device controller extending along (e.g., through, or externally and along) the flexible elongated member from its proximal end to its distal end (e.g., traveling beyond the distal end of the shaft and entering a second configuration to engage tissue). The distal end of the tissue manipulation device controller is coupled or engaged with at least one gripper arm to control the movement of the gripper arm as required or instructed by the procedure using the tissue manipulator. The proximal end of the tissue manipulation device controller can be engaged or coupled to or otherwise associated with a control handle associated with the tissue manipulation system and assisting in the actuation of the tissue manipulation device controller and other components of the tissue manipulation system. Any of the various control handles known in the art or to date can be used to manipulate the tissue manipulation device controller (and other components or structures of the tissue manipulation system), for example, through its proximal end; the specific details of the configuration do not limit the scope of this disclosure. In some embodiments, the tissue manipulation device controller can advance distally or retract proximally to manipulate the position of the gripper arm relative to the axis, thereby moving the gripper arm between a closed configuration and an open configuration.

[0070] Various features can be provided to facilitate gripping, grasping, moving (such terms are used interchangeably herein and are not intended to be limiting) tissue, etc. According to some embodiments described herein, at least one of the gripper arms can be shaped and configured to enhance tissue engagement and / or gripping. In some embodiments, the free end (e.g., distal end) of at least one of the gripper arms is shaped and configured to enhance engagement and / or gripping of tissue, for example, by locking onto 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 (the end connected to the rest of the tissue manipulation device, e.g., the proximal end) and the free end.

[0071] According to some embodiments disclosed herein, the distal end of a tissue manipulation device can be configured to facilitate its penetration through the wall of the tissue to be manipulated. In some embodiments, the distal end of the tissue manipulation device is provided with a tip, such as a needle or other sharp element, capable of piercing the tissue wall. In some embodiments, the tip may be associated with a shaft and / or a gripper arm.

[0072] According to some embodiments disclosed herein, a gripper arm may be coupled to a tissue gripper assembly configured to be releasable from a tissue manipulation device controller for deployment together with the tissue gripper assembly to keep closely spaced tissues juxtaposed. Other embodiments of tissue grippers are also disclosed, which can be deployed and remain in place to hold tissues together (e.g., to bring together the walls of different organs or lumens, or to repair defects and hold tissues around the defects together).

[0073] Various embodiments of organizational manipulation devices, systems, and methods will now be described with reference to the examples shown in the accompanying drawings. References to “one embodiment,” “an embodiment,” “some embodiments,” “other embodiments,” etc., throughout this specification indicate that one or more specific features, structures, and / or characteristics based on the principles of this disclosure may be included in the embodiments. However, such references do not necessarily imply that all embodiments include the specific features, structures, and / or characteristics, or that one 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. Furthermore, references to “one embodiment,” “an embodiment,” “some embodiments,” “other embodiments,” etc., throughout the specification do not necessarily refer to the same embodiment, and individual or alternative embodiments do not necessarily exclude other embodiments from each other. When a specific feature, structure, and / or characteristic is described in connection with an embodiment, it should be understood that such features, structures, and / or characteristics may also be used in connection with other embodiments, whether explicitly described or not, unless explicitly stated to the contrary. It should also be understood that such features, structures, and / or characteristics may be used or exist alone, or in various combinations thereof, to create alternative embodiments considered part of this disclosure, since describing all possible combinations and sub-combinations of features, structures, and / or characteristics would be overly cumbersome. Furthermore, various features, structures, and / or characteristics that may be demonstrated by some embodiments but not by others are described. Similarly, various features, structures, and / or characteristics or requirements are described that 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.

[0074] Turning now to the accompanying drawings, a tissue manipulation system 100 formed according to the principles of this disclosure is shown in a schematic diagram of the gastrointestinal system, for example, forming an anastomosis between the stomach S and a portion of the small intestine SI (e.g., the jejunum J). It should be understood that the gastrointestinal system is only one of many anatomical sites in which the tissue manipulation system 100 formed according to the principles of this disclosure can be used, and this does not affect the scope of the disclosure or limit the anatomical sites of the disclosed tissue manipulation system 100. The tissue manipulation system 100 may include a delivery device, such as a flexible elongated member 102 having a working channel, such as an endoscope, cannula, delivery shaft, etc. (for convenience, the term flexible elongated member as used herein generally refers to a delivery device and is not intended to be limiting), through which a tissue manipulation device 110 is guided to a treatment site TS. The tissue manipulation device 110 includes a tissue gripper assembly 120 at a distal end 111 of the tissue manipulation device, the tissue gripper assembly being configured to engage tissue to be manipulated by the tissue manipulation device 110. A tissue manipulation controller 130 (schematically extended through the flexible elongated member 102 in dashed lines) extends from the tissue gripper assembly 120 to the proximal end 113 of the tissue manipulation device 110 for access and manipulation by a user (e.g., a medical professional, such as a physician, technician, endoscopist, etc., and / or an automated system, etc.) to control the tissue gripper assembly 120. The tissue manipulation device 110 may be arranged relative to the tissue manipulation system 100 such that the tissue gripper assembly 120 extends from the distal end 101 of the tissue manipulation system 100, and the proximal end 133 of the tissue manipulation controller 130 is located at or along the proximal end 103 of the tissue manipulation system 100. The control handle 104 may be located at the proximal end 103 of the tissue manipulation system 100 and may be associated with the controller of the tissue manipulation device controller 130 and / or the controller of the flexible elongated member 102 (any controllers known in the art or known to date are not described here as they are not necessary for a full understanding of the tissue manipulation device 110).

[0075] According to known or prior art, tissue manipulation device 110 is configured to be delivered to treatment site TS via flexible elongated member 102 for advancing a device or system through the patient's anatomy to reach treatment site TS. The distal end 111 of tissue manipulation device 110 may have a profile configured to easily pass through proximal and distal tissue walls via openings, as can be understood, for example, with reference to various embodiments of tissue manipulation devices and tissue gripper assemblies disclosed herein (see, for example, FIG. 2). The distal end 111 of tissue manipulation device 110 may be configured to easily pass through holes or channels designated for tissue manipulation (e.g., for passage or by tissue manipulation device, as discussed further in detail below) without causing any undesirable damage (e.g., abrasions, cuts, tears, etc.). In some embodiments, the distal end 111 of tissue manipulation device 110 is configured to pierce and then pass through a tissue wall, as described further in detail below.

[0076] According to one aspect of the disclosure, the tissue gripper assembly 120 includes one or more gripper arms 122 carried by a shaft 116 (e.g., via a flexible elongated member 102) for delivery to a treatment site TS. The gripper arms 122 can be stored in a closed configuration within the shaft 116 and have a sufficiently low profile for distal movement by the tissue manipulation system 100. A tissue manipulation controller 130 is actuable (e.g., movable) to actuate the tissue gripper assembly 120 to move the gripper arms 122 from the closed configuration to an open configuration, wherein the gripper arms 122 expand and / or extend away from the shaft 116 to provide a configured and shaped gripper surface with sufficient surface area to engage the tissue to be manipulated. In some embodiments, the tissue manipulation controller 130 moves distally or proximally to actuate the gripper arms 122. However, other movements or controls of the tissue manipulation controller 130 are within the scope of this disclosure, and specific movements are not particularly important to the broad principles of this disclosure.

[0077] Examples of embodiments of the tissue gripper assembly 220 formed according to various principles of this disclosure are shown in Figure 2A-2C As shown in the figure. The tissue gripper assembly 220 shown has one or more gripper arms 222, such as Figure 2A and Figure 2B As shown, the gripper arm is in a closed configuration, at least partially retained within shaft 216, for delivery to the treatment site TS. If desired, the gripper arm 222 can be shaped and configured to present a compact structure within the lumen 217 of shaft 216, for example, referencing... Figure 2B Understandable. In some embodiments, such as Figure 2AAs shown, when the tissue manipulation device 210 advances to the treatment site TS, the distal end 221 of the grasper arm 222 can extend distally and outwardly from the distal end 215 of the shaft 216. If desired, a sharp element (e.g., separately formed and attached to the distal end of the grasper arm 222, or formed as part or an extension of the distal end of the grasper) can be provided on the distal end 221 of the grasper arm 222, such as... Figures 7A-7C The sharp element shown and further described in detail below is used to pierce the tissue wall to allow the tissue gripper assembly 220 to pass through the tissue wall. Alternatively, if the distal end 221 of the gripper arm 222 does not extend distally from the distal end 215 of the shaft 216, the sharp element 150 may be provided or formed on the end 215 of the shaft 216. Providing such a sharp element on the tissue gripper assembly 220 can facilitate tissue manipulation procedures, for example, by reducing the amount of work and / or the necessary instruments or devices. If no sharp element is provided, an opening through which the tissue gripper assembly 220 passes through the tissue wall can be pre-formed in the tissue wall (e.g., by a separate cutting instrument) before the tissue gripper assembly 220 is inserted through the tissue wall.

[0078] Figure 2A-2C The gripper arm 222 of the tissue gripper assembly 220 can be from Figure 2A The closed configuration is moved, extended, or expanded (these terms are used interchangeably in this document and are not intended to be limiting) to, for example, Figure 2C The open configuration shown includes a gripper arm 222 extending or expanding outward from the shaft 216 / tissue gripper assembly 220 (e.g., radially outward or transverse to the longitudinal axis L of the shaft 216 or tissue gripper assembly 220). According to one aspect of this disclosure, the gripper arm 222 is resiliently biased to expand or otherwise extend into the open configuration (e.g., extending away from the shaft 216) for engaging tissue to be manipulated. In some embodiments, for example... Figure 2A-2C In some embodiments, the gripper arm 222 is formed of a shape memory material (e.g., stainless steel or a shape memory alloy, such as nitinol), and the gripper arm 222 is shaped and configured to be biased toward an open configuration extending away from the longitudinal axis L of the shaft 216 or the tissue gripper assembly 220. When the gripper arm 222 is in a storage configuration within the shaft 216, the shaft 216 holds the gripper arm 222 in a closed configuration against the natural biasing of the gripper arm 222. In some embodiments, the gripper arm 222 includes an articulation or other bending or steering feature 227 shaped, configured, and positioned to hold the gripper arm 222 in a compact configuration within the shaft 216, for example by pressing against the interior of the shaft 216 to bias the gripper arm 222 into a compact closed configuration within the shaft 216. In some embodiments, the gripper arms 222 cross each other when in a closed configuration and move past each other to expand or extend into an open configuration, as referenced. Figure 2D and2E As understandable. Once the gripper arm 222 extends distally beyond the shaft 216, the gripper arm 222 can expand or extend to... Figure 2C The configuration is shown below.

[0079] In one embodiment, the gripper arm 222 can be moved by actuating a tissue manipulation controller 230. The tissue manipulation controller 230 is connected to the gripper arm 222 and extends proximally, for example, to a position such as... Figure 1 The proximal end 113 of the illustrated tissue manipulation device 110 and / or the proximal end 103 of the tissue manipulation system 100 are accessible to a user, thereby actuating the tissue manipulation device controller 230 to operate the gripper arm 222 to move as needed (e.g., relative to axis 216), such as between closed and open configurations. The tissue manipulation device controller 230 can be coupled to the gripper arm 222 via a controller connector 240 known in the art or to date, capable of transmitting desired controlled movements or actions from the tissue manipulation device controller 230 to the gripper arm 222. The controller connector 240 preferably holds the proximal end 223 of the gripper arm 222 in place while allowing the gripper arm 222 to bend or otherwise move (e.g., radially outward movement or expansion). The controller connector 240 may be located within a window, cutout, or recess within axis 216 to restrain or lock the gripper arm 222 in a desired configuration. Additional collars or stops may be provided on the proximal end 213 of shaft 216 to create a hard stop for controller connector 240. Alternatively, friction or specific geometry (interlocking) between gripper arm 222 and controller connector 240 and / or shaft 216 can induce a desired engagement of the system to hold gripper arm 222 in a desired position or configuration. Other configurations, such as bayonet locks or other elements, are within the scope of this disclosure.

[0080] In some embodiments, the tissue manipulation device controller 230 may include a controller element 232 in the form of wire or other elements or structures known in the art or to date capable of moving the gripper arm 222 relative to tissue. The controller element 232 may be able to extend to or be coupled to an additional controller element at the proximal end 103 of the tissue manipulation system 100 for user operation or control, for example via a control handle 104 located at the proximal end 103 of the tissue manipulation system 100. The controller element 232 is shown coupled to or otherwise engaged with a controller coupler 240. Movement of the controller element 232 (e.g., distal or proximal translation of the controller element 232) imparts movement to the tissue gripper assembly 220 to move the gripper arm 222 between closed and open configurations. It should be understood that other configurations of the tissue manipulation device controller and controller coupler are possible within the scope and spirit of this disclosure, and the operation and movement of the gripper arm are not limited to a particular configuration of the controller or controller coupler.

[0081] In the open configuration, the gripper arm 222 has a gripper surface 225, which is preferably shaped and configured to have sufficient surface area to engage tissue, allowing the gripper arm 222 to move to manipulate the tissue. Figure 2C As shown, at least one of the grasper arms 222 has a free end 221 (as used herein, a "free end" of an element is the end beyond which the element does not extend) provided with a tissue grasping feature 260 configured to facilitate grasping or engaging tissue, such as barbs, hooks, jaws, or other tissue engaging protrusions. The tissue grasping feature 260 is configured to enhance the grasp of tissue such that the grasper arm 222 does not inadvertently move relative to the manipulated tissue wall, or relative to the tissue wall held in place by the tissue grasper assembly 220 deployed and retained in place (e.g., holding juxtaposed tissues of different organs or lumens together, or holding tissues around a defect together to repair the defect, as described in further detail below). For example, the tissue grasping feature 260 can retain the grasper arm 222 to prevent lateral movement relative to the engaged tissue. Figure 2C In the illustrated embodiment, the tissue gripping feature 260 is in the form of curved jaws with distally facing tips to improve gripping. However, other configurations, positions, etc., including but not limited to those disclosed herein, may replace the illustrated tissue gripping feature 260. (Refer to...) Figure 2A and 2CIt is understood that the grasper arms 222 may be curved, such that in the closed configuration, the grasper arms 222 are positioned such that the convex curved sides or the surfaces facing each other present a convex (e.g., non-invasive) surface at the distal end 221 of the tissue grasper assembly 120. Upon moving to the open configuration, the grasper arms 222 cross each other and move away from the longitudinal axis LA to present convex curved sides distally, such that the concave curved sides face the treatment site TS, wherein the tissue grasping feature 260 is positioned to engage the tissue at the treatment site TS.

[0082] Alternative embodiments of the tissue gripper assembly 320 having a gripper arm 322 including one or more tissue gripping features 360 are described below. Figure 3A and 3B As shown in the figure. It can be understood that the illustrated tissue grasping feature 360 ​​is located at the corresponding distal end 321 of the corresponding grasper arm 322, and may be wider than the distally extending portion of the tissue grasping feature 360 ​​extending from it on the corresponding grasper arm 322. In such a configuration, the tissue grasping feature 360 ​​has a proximal tissue engagement end 363 (blunt or sharp, but not sharp enough to pierce or cut tissue), which is configured and positioned so that when the tissue manipulation device 310 is in the grasper arm 322... Figure 3B When moved proximally in the open configuration shown, tissue is engaged, contacted, or grasped at the treatment site TS. The tissue engagement end 363 can be configured to facilitate locking onto or otherwise engaging with the tissue at the treatment site TS. Further proximal movement of the tissue manipulation device 310 involves proximal movement or manipulation of the engaged tissue by the tissue manipulation device 310. In some embodiments, as shown, the tissue grasping feature 360 ​​may include a sharp element 350, such as a sharp region (or a sharp element coupled to the distal end 361) of the tissue grasping feature 360, for example, to pierce the tissue wall to obtain access as described above with respect to other embodiments of sharp elements on the distal end of a grasper arm or shaft.

[0083] In some embodiments, the tissue gripping feature is configured to contact or engage tissue to move the tissue as the tissue gripper assembly and tissue manipulation device move, but is not otherwise inhibited or restricted in terms of displacement relative to the engaged tissue (e.g., lateral movement). Such a tissue gripping feature may be said to contact or abut the engaged tissue without locking into it, or engage the tissue in a manner that allows the tissue gripping feature to grip the tissue independently (e.g., like a hook or barb or the like, which locks into the tissue so that the tissue can be gripped independently of further movement or features of the gripper arm). In some cases of such embodiments, the tissue gripping feature is in the form of a blunt or smooth surface, such as a surface that does not lock into the tissue. In some further instances of such embodiments, the gripper arm has a gripper surface with a comparatively increased surface area compared to the area or portion of the gripper arm distal to this tissue gripping feature and / or compared to a tissue gripping feature that can grip tissue independently of other features or movements of the gripper arm (e.g., by locking into the tissue).

[0084] Examples of manipulation and movement of the tissue manipulation device 110 formed according to the principles of this disclosure when used in accordance with certain aspects of this disclosure are shown in... Figures 4A-4D As shown in 5A-5C and 6A-6C. Although the illustrated tissue manipulation device 110 may be similar to Figures 2A-2E The organization's manipulation device 210, but it should still be understood that, Figures 4A-4D The embodiments of 5A-5C and 6A-6C are not limited to the specific configuration of the tissue manipulation device, but other configurations, such as those disclosed herein or others, may be used.

[0085] like Figure 4A As shown, the tissue manipulation device 110 is illustrated in a closed configuration, having been conveyed by a transport device (e.g., a flexible elongated member 102, if used, such as...) Figure 1 The distal end of the tissue manipulator 110 is advanced distally, optionally through a proximal body cavity or lumen (not shown), and is shown as approaching the treatment site TS, such as the distal tissue wall DTW. Before insertion of the tissue manipulator assembly 120, an opening for the tissue manipulator assembly 120 to penetrate the distal tissue wall DTW can be pre-formed in the tissue wall (e.g., by a separate cutting procedure). Alternatively, if a sharp element is provided on the distal end 101 of the tissue manipulator 110, the sharp element can create the opening, for example by piercing the distal tissue wall DTW with the sharp element. Figure 4B In this embodiment, the tissue manipulation device 110 is shown extending through the distal tissue wall (DTW) (e.g., organ wall, such as the stomach wall, or the wall of a lumen remote from the proximal body cavity or lumen) and into the distal body cavity or lumen. Figure 4CIn the figure, the tissue gripper assembly 120 is shown moving or already moved to an open configuration (e.g., via operation of the tissue manipulation device controller 130, not shown in this figure). The tissue gripper assembly 120 then moves proximally to engage the distal tissue wall DTW (e.g., engaging with gripper arms 122, such as with tissue gripper surfaces 125 and / or tissue gripping features 160 formed on one or more gripper arms 122). Figure 4D As shown, the distal tissue wall DTW can then be manipulated to a desired position as needed, such as proximal (e.g., the distal lumen can be moved proximal) toward the proximal tissue wall and optionally juxtaposed with the proximal tissue wall.

[0086] In various other embodiments described in or within the scope of this disclosure, and according to one aspect of this disclosure, once tissue / organ has been manipulated (e.g., pulled back) to its desired position, the user may remove the tissue manipulation device 110, or the procedure may continue with the tissue manipulation device 110 held in place or the tissue gripper assembly 120 deployed (disassembled from other components of the tissue manipulation device 110 and remaining in place). For example, the tissue gripper assembly 120 may move disengage from engagement with the treatment site TS, return to a closed configuration, and move proximally, e.g., out of the body. Further procedures may then be performed at the treatment site TS. Alternatively, the deployed tissue manipulation device 110 may remain in place to hold tissue in the desired position (e.g., juxtaposed with another tissue or organ) as the end or goal of the procedure, or may be used to close large tissue defects or perforations (e.g., within a single lumen). In some embodiments, the tissue gripper assembly 120 is formed with a collar, capsule, or capillary tube 126 removably mounted on the distal end 115 of the shaft 116 (such terms are substantially interchangeable, and the term "capsule" is used herein for convenience and not intended to be limiting), wherein the gripper arm 122 is connected to or otherwise mounted in the capsule 126. In some embodiments, the capsule 126 may be removed or detached from the shaft 116 to deploy the tissue gripper assembly 120 to hold at the treatment site TS (with the gripper arm 122 engaging the treatment site TS) and to remove the shaft 116 and the remaining elements of the tissue manipulation device 110. It should be understood that the references to shaft or capsule herein are interchangeable, and "capsule" is not limited to referring to a separate element coupled to the "shaft".

[0087] In one embodiment, such as Figures 5A-5C As shown, once the distal tissue wall DTW has moved to be juxtaposed with the proximal tissue wall PTW (e.g., according to...), Figures 4A-4D(The process or method shown), locking feature 128, such as a chuck or other suitable structure known in the art or known to date, having elements shaped and configured to engage with elements of tissue gripper assembly 120, can be actuated to retain tissue gripper assembly 120, wherein gripper arm 122 engages tissue at treatment site TS, for example in... Figure 5A In the open configuration shown, locking feature 128 can engage capsule 126 (or other parts of tissue gripper assembly 120) to hold juxtaposed tissues together, such as... Figure 5B As shown. This can be achieved via external catheters or internal push rods or control lines, which are responsible for holding and actuating the components in any of a variety of known ways. Locking feature 128 may include a flange or other region (e.g., a widened region) providing the tissue gripping surface 125. The shaft 116 can then be removed or detached from the tissue gripper assembly 120 (e.g., removed or detached from the shaft 116) and retracted proximally from the treatment site TS, as Figure 5C As shown. Friction, locking plates, barbs, forced stops, ratchet locks, etc., known in the art can be used or applied. It should be understood that, in accordance with the principles of this disclosure, any of a variety of other locking features can be used to hold the tissue gripper assembly 120 and the gripper arm 122 in place after the shaft 116 has been separated from it.

[0088] It is understood, and as stated above, that the tissue manipulation device 110 according to the principles of this disclosure can be used in a variety of surgical procedures other than pulling and / or holding the tissue walls of different organs or lumens together. For example, as Figures 6A-6C As shown, the tissue manipulation device 110 can be used to repair defects, for example, by pulling tissue walls together at different (e.g., opposite) sides or edges of the defect. Figure 6A As shown, the tissue gripper assembly 120 can be advanced into the tissue defect TD and one of the gripper arms 122 can engage with the tissue wall along the side or edge of the tissue defect TD, for example by engaging the gripping feature 160 of the gripper arm 122 and the tissue. The tissue gripper assembly 120, with the gripper arm 122 in an open configuration, along with the gripped tissue, then moves through the defect, and another gripper arm 122 engages along the tissue defect TD with another area of ​​the tissue wall (e.g., the tissue wall at a location on the tissue defect opposite the portion of the tissue wall that has already been gripped), such as... Figure 6B As shown. The gripping feature 160 on the gripper arm 122, which engages the initially gripped tissue region, helps to keep the gripper arm 122 on the initially gripped tissue region. When tissue along different regions of the tissue defect TD is engaged by different gripper arms 122, the tissue gripper assembly 120 moves to a closed configuration, as shown. Figure 6C As shown, the tissues are pulled together. Lock feature 128, for example... Figures 5A-5C As shown, it can be used to maintain the relative position and grip of the tissue grasper assembly 120 and the grasped tissue area. The tissue grasper assembly 120 can remain in place in a closed configuration, maintaining tissue wall juxtaposition and reducing the size of the tissue defect TD to allow for defect healing. It is understood that the gripping feature 160 can help hold the tissue grasper assembly 120 on the tissue throughout the repair process.

[0089] As will be understood, various alternative configurations of the tissue gripper assembly 120 that can be expanded from a closed configuration to an open configuration are within the scope of this disclosure, as will now be described. For example, various tissue gripper assemblies within the scope of this disclosure, such as... Figures 7A-7C As shown in 8A-8C, 9A-9C, and 10A-10C, a gripper arm is formed, which is resilient and biased to extend into or remain in an open configuration. Other tissue gripper assemblies can expand from a closed configuration to an open configuration, such as... Figure 11A , 11B As shown in 12A and 12B.

[0090] As briefly described above, a sharp element may be disposed at the distal end of a tissue manipulation device formed according to various principles of this disclosure, for example... Figures 7A-7C As shown in the example of the tissue gripper assembly 420, a sharp element 450 may be formed at the distal end 421 of the gripper arm 422 to extend distally therefrom. The sharp element 450 may encounter and pierce the tissue wall at the treatment site TS to allow the remainder of the tissue gripper assembly 420 to extend through it. Figures 7A-7C The gripper arm 422 of the tissue gripper assembly 420 and other features of the tissue gripper assembly 420 may otherwise be substantially similar. Figure 2A-2C Features of the tissue gripper assembly 220 shown.

[0091] Different configurations of the elastically biased gripper arm are shown. Figures 8A-8C middle. Figures 8A-8C The gripper arm 522 of the tissue gripper assembly 520 shown may be configured as two or more (e.g., three or four or more) curved rods housed within a shaft 516 (or a removable capsule 526 coupled to the shaft, such as the removable capsule described above) and biased to a stored configuration extending along the longitudinal axis LA of the shaft 516 or capsule 526 and / or tissue gripper assembly 520. When actuated by the tissue manipulation device controller (e.g.) Figure 2A-2C (As shown in embodiments 7A-7C), the gripper arm 522 can be advanced distally to extend distally from the shaft 516 or the bladder 526. The gripper arm 522 is no longer confined within and constrained by the shaft 516 or the bladder 526, and can freely expand or extend outward relative to the longitudinal axis LA (e.g., radially outward or laterally), as... Figure 8C As shown. At least two gripper arms 522 extend in different directions when in the open configuration to present a gripper surface 525, which is configured and shaped to have sufficient surface area to engage with the tissue to be manipulated. Tissue gripping features 560, such as barbs, hooks, jaws, or other tissue-engaging protrusions, may be provided to facilitate tissue gripping, as described above with reference to the previously described embodiments.

[0092] Formed in accordance with the principles of this disclosure and Figures 9A-9C In another embodiment shown, the tissue gripper assembly 620 is formed with a substantially straight gripper arm 622, such as in the form of a resilient elongated element or rod. When the tissue manipulation device controller 630 (e.g., any tissue manipulation device controller described herein) is actuated to advance the tissue gripper assembly 620 distally, the gripper arm 622 extends from the distal end 615 of the shaft 616 (or a removable capsule 626 connected to the shaft, such as a capsule as described above). As the gripper arm 622 exits the distal end 615 of the shaft 616 or the capsule 626, the gripper arm 622 encounters a steering feature 627 (e.g., a wall or other obstacle or impediment) at the distal end 615 of the shaft 616 or the capsule 626 and is bent or deflected to exit transversely to the longitudinal axis LA of the tissue gripper assembly 620, through a corresponding exit opening 629, such as forming a “T” shape when open. Figure 9B and 9C As shown, a grasper surface 625 is presented proximally to engage with the tissue wall. Tissue grasping features 660, such as hooks or barbs or other tissue-engaging protrusions, may be provided or formed at one or more free ends 621 of the grasper arm 622 to facilitate tissue grasping.

[0093] It should be understood, for example, in Figures 10A-10C In the illustrated embodiment, the tissue gripper assembly can be formed with a shape similar to Figures 9A-9C A single gripper arm of the gripper arm in an embodiment. More specifically, refer to... Figures 10A-10C The tissue gripper assembly 720 shown has a single elongated gripper arm 722 that can be held or confined within a shaft 716 (or a removable capsule 726 coupled to the shaft, such as the capsule described above) and biased into a storage configuration extending along the longitudinal axis LA of the shaft 716 or the capsule 726 and / or the tissue gripper assembly 720. Figures 9A-9CSimilar to the tissue gripper assembly 620, when the tissue manipulation device controller 730 (e.g., any tissue manipulation device controller described herein) is actuated to advance the tissue gripper assembly 720 distally, the gripper arm 722 extends from the distal end 715 of the shaft 716 (or the removable capsule 726 coupled to the shaft, such as a capsule as described above). As the gripper arm 722 departs from the distal end 715 of the shaft 716 or the capsule 726, the gripper arm 722 encounters a steering feature 727 (e.g., a wall or other obstacle or obstruction) at the distal end 715 of the shaft 716 or the capsule 726 and is bent or deflected to depart laterally to the longitudinal axis LA of the tissue gripper assembly 720, as... Figure 10C As shown. With Figures 9A-9C The steering feature 627 of the tissue gripper assembly 620 is different. Figures 10A-10C The steering feature 727 of the tissue gripper assembly 720 preferably has a single exit opening 729 to guide the gripper arm 722 in a desired direction. Tissue gripping features 760, such as hooks or barbs or other tissue-engaging protrusions, may be provided or formed along the gripper arm 722 to facilitate tissue gripping. More than one tissue gripping feature 760 is shown, such as one at the free end 721 of the gripper arm 722 and another extending along the gripper surface 725 of the gripper arm 722. However, it should be understood that the tissue gripping feature 760 can be other configurations as described herein.

[0094] The gripper arm of the tissue manipulator assembly formed according to various principles of this disclosure can be elastically biased to extend away from the axis of the tissue manipulator in directions other than radially outward. For example, as in Figure 11A and 11B In the illustrated embodiment, the tissue manipulation device 810 may have a tissue gripper assembly 820 having a helical gripper arm 822 held in a substantially compact or elongated / straight configuration within a shaft 816 of the tissue manipulation device 810 in a closed configuration (or a removable capsule 826 coupled to the shaft, such as a capsule as described above, or within a delivery device of the tissue manipulation system 100), as Figure 11AAs shown. The gripper arm 822 can be actuated to move between a closed configuration and an open configuration, for example, when a tissue manipulation device controller, not shown, is actuated, can be configured as described with reference to other embodiments herein. The gripper arm 822 can be coupled to the tissue gripper assembly 820 in any manner known in the art or to date, for example via a controller connector as described herein with reference to other embodiments. In one embodiment, distal movement of the gripper arm 822 causes the distal end 821 to extend from the distal end 815 of the shaft 816 or the capsule 826, for example, through an exit opening 829. When no longer constrained by the shaft 818, the gripper arm 822 can expand into a helical shape, the configuration and dimensions of which (having an outer diameter larger than the outer diameter of the shaft 816 or the capsule 826 and having sufficient volume) are adapted to engage tissue, such that movement or manipulation of the tissue manipulation device 810 of the tissue gripper assembly 820 causes the desired manipulation of the engaged tissue. For example, in one embodiment, the helical configuration includes more than one turn of gripper arm 322, the turns of which are substantially concentric and coplanar to form a gripper surface 825 comprising multiple turns of helix. It should be understood that other configurations that extend sufficiently radially outward to engage tissue and have sufficient strength to pull tissue are also within the scope of this disclosure as the tissue gripper assembly 820 moves proximally.

[0095] The gripper arm of the tissue gripper assembly of the tissue manipulation device formed according to various principles of this disclosure can be extended in other ways to expand away from the axis of the tissue manipulation device. For example, as Figure 12A and 12B In the illustrated embodiment, the tissue manipulation device 910 may have a tissue gripper assembly 920 having a gripper arm 922 in the form of a radially outwardly expandable element (e.g., a balloon). The gripper arm 922 is held in a substantially compact configuration within the shaft 916 of the tissue manipulation device 910 in a closed configuration, such as... Figure 12A As shown. The gripper arm can extend distally from shaft 916 to expand according to various known or to date methods for expanding such a gripper arm, such as inflation. The gripper arm 922 can be moved to engage with tissue, such that the tissue manipulation device 910 that moves or manipulates the tissue gripper assembly 920 moves or manipulates the tissue that causes the gripper arm 922 to move or manipulate. A sharp element 950, such as a sharp tip or needle, may be provided at the distal end 915 of shaft 916, such that the tissue gripper assembly 920 can pierce the tissue wall through which the tissue gripper assembly 920 extends.

[0096] According to one aspect of this disclosure, the resiliently biased gripper arm can be in the form of a wire, such as a wire resiliently biased into a tissue hook configuration. Generally, refer to... Figure 13A and 13BThe tissue manipulation device 1110 may have a tissue gripper assembly 1120 having a gripper arm 1122 in the form of a wire, the distal end 1121 of which is bent into the form of a barb or hook (such terms are used interchangeably herein and are not intended to be limiting). The tissue gripper assembly 1120 may be advanced distally through a pre-made opening (or punctureable tissue) in the tissue at the treatment site TS, and the hook-shaped distal end 1121 of the gripper arm 1122 moves to engage with the distal surface of the tissue. The bent distal end 1121 of the gripper arm 1122 may be made of a shape memory alloy (e.g., nitinol) to facilitate the distal end 1121 in a straight configuration through the working channel of the shaft 1116 or other delivery device before reforming the hook upon exiting the distal end of the shaft 1116 or delivery device (e.g., upon reaching the treatment site TS). In some embodiments, such as those described herein, the tissue gripper assembly 1120 extends through the proximal tissue wall (PTW) and the distal tissue wall (DTW), and the tissue gripper assembly 1120 moves proximally to pull the walls together, e.g., juxtapose them. The distal end 1121 of the gripper arm 1122 may be sharp enough to pierce the proximal tissue wall (PTW). Once the tissue is positioned as needed, e.g., by a controller (e.g., a controller disclosed herein with reference to other embodiments, or another suitable controller known in the art or to date), a locking feature 1128 may be deployed to hold the tissue gripper arm 1122 in place relative to the tissue. In one embodiment, the locking feature 1128 includes a retaining feature 1170, such as a deployment cap, deployment collar, or deployment capsule, having a gripping surface 1175 configured to engage the proximal surface of the proximal tissue wall (PTW) and, together with the gripper arm 1122, hold the proximal tissue wall (PTW) and the distal tissue wall (DTW) in place. In one embodiment, retaining feature 1170 may be configured to hold the distal end 1121 of the gripper arm 1122 in place. Retaining feature 1170 may also enclose, shield, or bury the optional sharp tip or distal end 1121 of the gripper arm 1122 to protect surrounding tissue from potential trauma. The proximal region of the filament forming the gripper arm 1122 may break, for example, but not limited to, by tension ball methods (e.g., a cup-ball configuration, separating the filament as it is pulled proximally from the treatment site TS), by breaking the filament along a pre-weakened region, by unsealing the capsule or damaging / destroying the tag, or by other structures that break under further tensile loads on the filament.

[0097] In one embodiment, such as Figure 14 As shown, similar to Figure 13A and 13BThe tissue manipulation device 1210 of the illustrated tissue manipulation device 1110 can utilize a delivery device 1202 having more than one lumen, such as a dual-lumen endoscope. A gripper arm 1222, for example in the form of a wire with pre-formed barbs or hooks at its distal end, can be advanced distally through the working channel of the first lumen. The shape of the hook allows the distal end 1221 of the gripper arm 1222 (e.g., the tip of the barb) to be aligned with another working channel of the delivery device 1202. Once the tissue is positioned as needed, for example by a controller (e.g., a controller disclosed herein with reference to other embodiments, or another suitable controller known in the art or to date), a locking feature 1228 can be deployed to hold the gripper arm 1222 in place relative to the tissue, and, for example, by frictional engagement. In one embodiment, the locking feature 1228 includes a retaining feature 1270, such as in the form of a collar or disc (these terms are used for simplicity and are used interchangeably herein without limitation, nor are they intended to limit such an element to a circular cross-sectional shape or other shapes), having a gripping surface 1275 configured to engage a proximal surface of tissue at the treatment site and, together with the gripper arm 1222, hold the tissue at the treatment site in the desired position. The retaining feature 1270 can be used as a deployment feature and / or as a stop to hold the tissue in place after deployment.

[0098] Locking feature 1228 may additionally include a deployment collar 1272, such as a protective cap. In some embodiments, the deployment collar 1272 is deployed through or otherwise positioned in another working channel of the delivery device 1202 (e.g., a working channel in which the distal end 1221 of the gripper arm 1222 is aligned once advanced out of the first working channel of the delivery device 1202). The size and shape of the deployment collar 1272 may be designed to receive the optional sharp tip of the distal end 1221 of the gripper arm 1222, for example, after it has pierced tissue at the desired location. The deployment collar 1272 can be used to stop or retain tissue and / or wrap or shield or bury the sharp tip (if provided) at the distal end 1221 of the gripper arm 1222 to protect surrounding tissue from potential trauma. Examples of embodiments of the tubular deployment collar 1272 are provided in Figure 15The diagram is shown in cross-section, illustrating a through-hole 1273 within a deployment collar 1272 through which the distal end 1221 of a gripper arm 1222 can pass. The through-hole 1273 may be formed in a retaining wall 1274 extending radially inward from the inner wall of the collar. The distal end 1221 of the gripper arm 1222 may be elastically biased outward and compressed to pass through the retaining wall 1274. The retaining wall 1274 may provide a retaining surface 1275 on its proximal side, such that once the distal end 1221 of the gripper arm 1222 passes through the through-hole 1273, the distal end 1221 expands into its relaxed expanded configuration (wider than the diameter of the through-hole 1273 in a direction transverse to the remaining proximal extension of the filament) and is prevented from retracting distally through the through-hole 1273, thereby locking in place relative to the deployment collar 1272 and the treatment site. It is understood that multiple retaining features 1270 and / or multiple deployment loops 1272 may be disposed on the tissue gripper assembly 1220 and may be coupled together, for example, by a pressure fit or similar features. It should also be understood that, as Figure 14 The tissue manipulation device 1210 shown may be provided with one or more gripper arms 1222, wherein the one or more gripper arms 1222 include metal barbs or the like.

[0099] refer to Figure 16 and Figure 17 , Figure 14 The tissue manipulation device 1210 can be used to close defects or to pull two separate lumens together and hold them together. For example, as... Figure 16 As shown, tissues on different sides of the tissue defect TD can be pulled together by the gripper arm 1222 and the tissue gripper assembly 1220, which holds the tissue in place by holding or locking the retaining feature 1270 to one side of the tissue defect and holding or locking the deployment collar 1272 to the other side of the tissue defect. Figure 17 As shown, the gripper arm 1222 can wrap around through the tissue to be held together at the treatment site TS. The tissue gripper assembly 1220 is held or locked in place by the retaining feature 1270 at the entry site (the position where the tissue gripper assembly 1220 initially enters the treatment site TS, and the position of the proximal end of the tissue gripper assembly 1220 once the tissue gripper assembly 1220 has been deployed at the treatment site TS) and by the deployment loop 1272 being held or locked in place by the exit site (the position where the distal end 1201 of the tissue gripper assembly 1220 leaves the treatment site TS, and the position of the distal end of the tissue gripper assembly 1220 once the tissue gripper assembly 1220 has been deployed at the treatment site TS).

[0100] In some embodiments, a gripper arm in the form of a flexible bias wire can be used in tissue manipulation devices suitable for closing large defects, for example in... Figure 18An example of the tissue manipulation device 1310 shown. (As in...) Figure 14 In the illustrated tissue manipulation device 1210, tissue manipulation device 1310 includes a gripper arm 1322, for example in the form of a wire having a pre-formed barb or hook at its distal end. The shape of the hook allows the distal end 1321 (e.g., the tip of the barb) of the gripper arm 1322 to face proximally. The gripper arm 1322 can extend through a lumen 1317 defined by a shaft 1316. The shaft 1316 can be advanced distally through the working channel of a delivery device 1302, such as a tissue manipulation system 1300, to advance the tissue manipulation device 1310 to a treatment site. Alternatively, the shaft 1316 can be delivered via an endoscope delivery system, including along (optionally not entirely around) an endoscope.

[0101] Figure 18 The tissue gripper assembly 1320 of the tissue manipulation device 1310 may include one or more tissue holding features 1370, which may be carried by a shaft 1316 and associated with a gripper arm 1322, for example, through a portion of the tissue holding feature by the gripper arm 132. The tissue holding feature 1370 may be in the form of a gripping ring or disc (such terms are used for simplicity and are used interchangeably herein without limitation, and such elements are not intended to be limited to a circular cross-sectional shape or other shapes), having a gripper surface 1325 configured to engage a proximal surface of the tissue at the treatment site and, together with the gripper arm 1322, hold the tissue at the treatment site in a desired position. The gripper arm 1322 and the holding feature 1370 may move relative to each other, for example, independently of each other, to allow various elements to engage the tissue at the treatment site to manipulate the tissue to achieve a desired procedure on the tissue, etc. In one embodiment, shaft 1316 has an inner shaft 1316i carrying a distal retaining feature 1370d and an outer shaft 1316o carrying a proximal retaining feature 1370p to allow relative movement between the retaining features 1370 to grasp or manipulate tissue and / or retain tissue therebetween.

[0102] The deployment collar 1372 can be movably carried by the shaft 1316 or deployed separately to hold the tissue gripper assembly 1320 (including gripper arms 1322 and one or more retaining features 1370) in the desired position at the treatment site. Figure 15 The deployment ring 1272 shown is shown. Figure 18The gripper arm 1322 of the tissue gripper assembly 1320 of the tissue manipulation device 1310 can be held (e.g., restrained or locked) relative to the deployment collar 1372, for example by engaging a retaining wall 1374 extending radially inward from the inner wall of the deployment collar 1372. More specifically, the distal end 1321 of the gripper arm 1322 can be resiliently biased outward and can be compressed to pass through a through-hole 1373 in the retaining wall 1374. The retaining wall 1374 may provide a retaining surface 1375 on its proximal side such that once the distal end 1321 of the gripper arm 1322 passes through the through-hole 1373, the distal end 1321 expands into its relaxed expanded configuration (wider than the diameter of the through-hole 1373 in a direction transverse to the remaining proximal extension of the filament) and is prevented from passing through the through-hole 1373, thereby locking in place relative to the deployment collar 1372 and the treatment site. More than one deployment collar 1372 may be provided, and the more than one deployment collar 1372 may be connected together, for example by a light press fit or similar feature. If needed, the distal deployment collar 1372 may be carried by the shaft 1316, and the proximal deployment collar 1372 may be deployed separately, for example through another working channel of the conveyor 1302.

[0103] Figure 18 The tissue manipulation device 1310 can be used to close defects, for example Figures 19A-19E The defects shown are illustrated. For example, such as... Figure 19A As shown, the distal retaining feature 1370d can be positioned distal to the distal tissue region, alongside the tissue defect TD to join the distal tissue. The proximal retaining feature 1370p can be positioned proximal to the joined distal tissue. The distal retaining feature 1370d can be moved proximally toward the proximal retaining feature 1370p to pull the retaining features 1370d and 1370p together to clamp the initially joined distal tissue between them, as shown. Figure 19B As shown, for example, by keeping the distal holding feature 1370d and the proximal holding feature 1370p close together (e.g., by controlling the relative positions of the inner shaft 1318i and the outer shaft 1316o that respectively carry the distal holding feature 1370d and the proximal holding feature 1370p). The distal end 1301 (facing proximally) of the gripper arm 1322 may be provided with a sharp tip to pierce and pass through the clamped tissue. The clamped distal tissue can be manipulated, pulled, or dragged proximally to the proximal tissue from the other side of the tissue defect TD, as... Figure 19C As shown. Proximal retention feature 1370p moves proximally away from distal retention feature 1370 (e.g.) Figure 19C As shown), this allows the proximal tissue on the other side of the tissue defect TD to be positioned between tissue retention features 1370d and 1370p to be held therein, as... Figure 19DAs shown, for example, tissue areas on opposite sides of a defect can be held together to repair or close the defect. The distal end 1301 of the grasper arm 1322 can be moved further proximally so that its sharp tip pierces the proximal tissue. The deployment collar 1372 is then moved into place and the distal end 1301 of the grasper arm 1322 can be held therein, holding the grasped tissue areas together to repair the defect. Figure 19E As shown, the deployment collar 1372 can be configured to replace the proximal holding feature 1370p (which can be removed and retrieved) at the proximal location where the defect is repaired. It is understood that the deployment collar 1372 can surround, shield, or bury the sharp tip of the gripper arm 1322 therein to protect surrounding tissue from potential trauma. The distal holding feature 1370d is deployed with the tissue gripper assembly 1320 to hold the tissue in place. The proximal holding feature 1370p can be deployed with the tissue gripper assembly 1320 or can be retained attached to the shaft 1316. The gripper arm 1322 can break off or otherwise detach from the proximal portion of the tissue manipulation device 1310 for deployment. For example, the gripper arm 1322 can be held by protrusions or locking tabs, or frictionally engaged within the inner shaft 1316i, which can be disengaged from the outer shaft 1316o and held together with the deployment component of the tissue gripper assembly 1320 during deployment. The deployment portion of the barb at the distal end 1301 of the gripper arm 1322 may include additional nodes, collars, or barbs that engage with the deployment collar 1372 to help maintain defect closure after deployment. Although Figures 19A-19E This can be understood as illustrating the use of tissue manipulation device 1310 to close defects, such as within the lumen of the gastrointestinal (GI) tract. The illustrated tissue manipulation device 1310 can be additionally or alternatively used to retract the intestine into the stomach for other gastrointestinal procedures, such as gastric bypass surgery. Several tissue gripper assemblies 1320 may be deployed around newly created openings, potentially forming permanent fistulas.

[0104] In view of the above, it should be understood that Figure 18 and 19A The tissue manipulation device 1310 of the -19E may be small enough to fit into the working channel of a delivery device (e.g., an endoscope), or it may be an exoscopy device, or a hybrid device having one or two retaining features 1370d, 1370p through the exoscopy and a deployment collar through the endoscopy, and a gripper arm 1322 through the exoscopy or endoscopy. In some embodiments, such as in the case of a hybrid device, the proximal retaining feature 1370p may be replaced by an endoscope cap, such as those commonly used in endoscopic submucosal dissection (ESD) and endoscopic submucosal resection (EMR) procedures. The hybrid device may also allow multiple gripper arms 1322 to be used with a pair of retaining features 1370.

[0105] Based on the various principles of this disclosure, yet another tissue manipulation device can be formed using principles such as the elastically biased gripper arm widely described herein. One embodiment of the tissue manipulation device 1410 is configured to pull tissue walls together and juxtapose them, as... Figures 20A-20C As shown. The tissue manipulation device 1410 can be configured to remain in place, anchoring tissue walls together (e.g., a portion of the intestine is anchored to the stomach, for example, in gastric bypass surgery), and can therefore be characterized as a rivet. As shown, the tissue manipulation device 1410 has one or more gripper arms 1422, in the form of, for example, curved rods, with a collar or capsule 1426 surrounding the middle of the tissue manipulation device 1410 between the proximal gripper arm 1422p and the distal gripper arm 1422. The tissue gripper assembly 1420 (capsule 1426 and gripper arm 1422) can be loaded into another sleeve, such as a delivery device, like the flexible elongated member 102 of the tissue manipulation system 100, or the shaft 1416 of the tissue manipulation device 1410, such as... Figure 20A As shown. The flexible elongated member 102 or shaft 1416 biases the gripper arm 1422 into a closed extension configuration, substantially flattening it and extending along the longitudinal axis LA of the capsule 1426 or tissue gripper assembly 1420 or shaft 1416, allowing the device to pass through the working channel of the flexible elongated member 102 of shaft 1416 and / or tissue manipulation system 100. Friction from the elastically biased gripper arm 1422 on the inner side of shaft 1416 (typically biased to extend into the radially outwardly extending open configuration, such as...) Figure 20C The arrangement shown may be sufficient to hold the tissue gripper assembly 1420 in the proper position within the shaft 1416; however, if not, internal connections to the gripper arm 1422 and / or the capsule 1426 may be required. Any connections or elements known in the art or to date that allow for disengagement as needed may be used, such as detachable push rods for hemostatic clamping and disengagement.

[0106] like Figure 20A As shown, the distal end 1411 of the tissue manipulation device 1410 passes through an opening (e.g., pre-formed) in the tissue wall to be pulled together until the distal end 1415 of the shaft 1416 is positioned through the distal tissue wall DTW to place the distal end of the tissue gripper assembly 1420 within the distal lumen. In the illustrated example, the distal end 1415 of the shaft 1416 passes through an opening in the target intestinal wall. The capsule 1426, together with the distal gripper arm 1422d, is partially pushed distally outward from the distal end 1415 of the sleeve 1416, as... Figure 20BAs shown, this allows the distal gripper arm 1422d to expand radially outward. The distal tissue wall DTW (e.g., intestine) can now be pulled back into the opening created in the proximal tissue wall PTW (e.g., stomach wall). Next, the shaft 1416 retracts further proximally, allowing the proximal gripper arm 1422p to release from the shaft 1416 and expand radially outward to... Figure 20C The open configuration is shown. If internal connection with the tissue gripper assembly 1420 is required, it can be disconnected to fully deploy the tissue gripper assembly 1420 to anchor the distal tissue wall DTW and the proximal tissue wall PTW together.

[0107] Based on the foregoing description, it should be understood that the devices, systems, and methods disclosed herein can be used to form one or more anastomoses and can be used in conjunction with basic endoscopic tools, catheters, laparoscopes, common surgical instruments, etc. For example, a catheter-based stent delivery device can be used with an endoscope to form an anastomosis, for example, between two parts of the intestine. Endoscopic devices can be used to form anastomoses between a gastric fundus and a portion of the intestine (e.g., the jejunum). Combinations of laparoscopic devices and catheter devices as described herein can also be used to form a single anastomosis.

[0108] The foregoing discussion has broad applications and has been presented for illustrative and descriptive purposes, and is not intended to limit the disclosure to one or more forms disclosed herein. It should be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concept, spirit, and essence of this disclosure. In particular, those skilled in the art will appreciate that the principles of this disclosure can be embodied in other forms, structures, arrangements, proportions, and other elements, materials, and components without departing from the concept, essence, or scope or characteristics of the invention. For example, various features of this disclosure are combined in one or more aspects, embodiments, or configurations for the purpose of simplifying this disclosure. However, it should be understood that various features of certain aspects, embodiments, or configurations of this disclosure can be combined in alternative aspects, embodiments, or configurations. While this disclosure is presented according to embodiments, it should be understood that not all of the various individual features of this subject matter need to be present in order to achieve at least some of the desired features and / or benefits of this subject matter or such individual features. Those skilled in the art will understand that this disclosure can be used with numerous modifications or alterations to the structure, arrangement, proportions, materials, components, etc., used in the practice of this disclosure without departing from the principles, spirit, or scope thereof, and these modifications or alterations are particularly suitable for specific environments and operational requirements. For example, an element shown as integrally formed may be composed of multiple parts, or an element shown as multiple parts may be integrally formed; the operation of an element may be reversed or otherwise varied; and the size or dimensions of an element may vary. Similarly, although operations or actions or processes are described in a particular order, this should not be construed as requiring such a particular order, or that all operations or actions or processes will be performed to achieve the desired result. Furthermore, other embodiments are also within the scope of the appended claims. In some cases, the actions recited in the claims may be performed in a different order, but still achieve the desired result. Therefore, the embodiments disclosed herein are to be considered illustrative rather than restrictive in all respects, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the specific embodiments or arrangements described or illustrated herein. In view of the foregoing, individual features of any embodiment may be used and may be claimed individually or in combination with features of that embodiment or any other embodiment, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0109] The following will be understood in the foregoing description and the following claims. As used herein, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are conjunctions and alternative words in operation. The terms “a,” “an,” “a certain,” “first,” “second,” etc., do not exclude plurals. For example, as used herein, the term “a” or “an” entity refers to one or more of that entity. Thus, the terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein. All directional references (e.g., proximal, distal, up, down, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or similar) are used only for identification purposes to aid the reader’s understanding of this disclosure and / or to distinguish areas of associated elements from one another, and do not limit the associated elements, particularly with respect to position, orientation, or the use of this disclosure. Unless otherwise stated, connecting references (e.g., attachment, connection, link, and union) are to be interpreted broadly and may include intermediate members between sets of elements and relative movement between elements. Therefore, a connection reference does not necessarily imply that two elements are directly connected and have a fixed relationship with each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to suggest importance or priority, but are used to distinguish one feature from another. The appended claims are incorporated herein by reference in this detailed description, each claim being an independent embodiment of this disclosure. Reference numerals in the claims are provided as illustrative examples only and should not be construed as limiting the scope of the claims in any way.

[0110] The following claims are incorporated herein by reference in this detailed description, each claim being an independent embodiment of this disclosure. In the claims, the term "comprising / including" does not exclude the presence of other elements or steps. Furthermore, while individual features may be included in different claims, these may be advantageously combined, and inclusion in different claims does not imply that the combination of features is unfeasible and / or unadvantageous. Moreover, singular references do not exclude plurals. Terms such as "a," "an," "some," "first," "second," etc., do not exclude plurals. Reference numerals in the claims are provided as illustrative examples only and should not be construed as limiting the scope of the claims in any way.

Claims

1. An organ manipulation device, comprising: A shaft, which has a longitudinal axis; An organization gripper assembly includes one or more resilient gripper arms that can expand between a closed configuration and an open configuration, wherein in the closed configuration, the one or more resilient gripper arms extend within the shaft and along the longitudinal axis of the shaft, and in the open configuration, the one or more resilient gripper arms extend laterally outside the shaft away from the longitudinal axis of the shaft. The gripper surface, associated with at least one of the gripper arms, is shaped and constructed to engage body tissue; and A controller, which is coupled to the tissue gripper assembly via a controller connector and configured to move the gripper arm between the closed configuration and the open configuration, is also included. In the closed configuration of the one or more resilient gripper arms, the one or more resilient gripper arms are positioned to present a non-invasive raised surface to body tissue; and In the open configuration of the one or more resilient gripper arms, at least one gripper arm is positioned away from the longitudinal axis to present a convex curved side distally, such that the concave curved side faces the treatment site.

2. The tissue manipulation device as claimed in claim 1, wherein, When positioned outside the axis, the gripper arm is resiliently biased into an open configuration in a radially outward direction away from the axis.

3. The tissue manipulation device as described in claim 1 or 2, wherein, The gripper arm is elastically held in the open configuration by a steering feature formed on the distal end of the shaft.

4. The tissue manipulation device as described in claim 1 or 2, characterized in that, The tissue gripper assembly can be detached from the axis and the controller to maintain the deployment of gripping body tissue.

5. The tissue manipulation device of claim 4, wherein the tissue gripper assembly includes a locking feature that is engageable to retain the at least one gripper arm engaging tissue when the tissue gripper assembly is disengaged from the shaft and the controller.

6. The tissue manipulation device of claim 4, further comprising a controller connector coupled between the gripper arm and the controller, and wherein, when the controller is actuated, the controller connector is movable to move the at least one gripper arm between the closed configuration and the open configuration, and the controller is detachable from the controller connector to deploy the tissue gripper assembly.

7. The tissue manipulation device as claimed in claim 4, wherein, The tissue gripper assembly also includes a capsule connected to the axis, the gripper arm being connected to the axis via the capsule, and the tissue gripper assembly being detachable from the capsule from the axis and the controller to maintain deployment and gripping of body tissue.

8. The tissue manipulation device of claim 1 or 2, further comprising a sharp element extending distally from the distal end of the tissue gripper assembly and configured to pierce the body tissue wall.

9. The tissue manipulation device as described in claim 1 or 2, characterized in that, The at least one gripper arm is an elastic bias line, and the gripper surface is disposed on a tissue retention feature associated with the gripper arm.

10. The tissue manipulation device as claimed in claim 1, characterized in that, At least one of the gripper arms includes a tissue gripping feature proximally facing the axis when the gripper arm extends distally beyond the axis and expands into the open configuration.

11. A tissue gripper assembly, comprising: The cyst body has a longitudinal axis; One or more resilient gripper arms that can expand between a closed configuration and an open configuration, wherein in the closed configuration, the one or more resilient gripper arms are inside the capsule and extend along the longitudinal axis of the capsule, and in the open configuration, the one or more resilient gripper arms are outside the capsule and extend laterally away from the longitudinal axis of the capsule. A gripper surface, associated with at least one of the gripper arms, is shaped and configured for engaging body tissue; and A controller connector, which is coupled to at least one of the gripper arms and movable to move the at least one gripper arm between the closed configuration and the open configuration. In the closed configuration of the one or more resilient gripper arms, the one or more resilient gripper arms are positioned to present a non-invasive raised surface to body tissue; and In the open configuration of the one or more resilient gripper arms, at least one gripper arm is positioned away from the longitudinal axis to present a convex curved side distally, such that the concave curved side faces the treatment site.

12. The tissue gripper assembly of claim 11, further comprising a locking feature that engages to retain the tissue gripper assembly in a configuration of engaging tissue.

13. The tissue gripper assembly as claimed in claim 11 or 12, wherein, The capsule is configured for connection to the distal end of the shaft.

14. The tissue gripper assembly as claimed in claim 11 or 12, wherein, The capsule has a proximal end and a distal end, and one or more gripper arms extend from each of the proximal end and the distal end of the capsule.

15. The tissue gripper assembly of claim 11 or 12, further comprising a sharp element extending distally from the tissue gripper assembly and configured to pierce a body tissue wall.

16. The tissue gripper assembly according to claim 11 or 12, wherein, At least one of the gripper arms is elastically held in an open configuration by a steering feature formed on the distal end of the shaft.

17. The tissue gripper assembly of claim 11, wherein one or more of the gripper arms have tissue gripping features configured to engage tissue.

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