Minimally invasive endoscopic suture device

Abstract

To provide an apparatus or method for suturing tissue with minimal invasiveness. 【Solution means】 The apparatus includes a tubular gripper including an elastic tip configured to expand outward when not energized, a needle disposed inside the tubular gripper and configured to penetrate tissue, a tubular anchor disposed on the needle, and a surgical thread passed through the tubular anchor.

Description

Technical Field

[0001] (Cross - Reference to Related Applications)

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 390,367, entitled "Minimally - Invasive Endoscopic Suturing Device", filed on July 19, 2022. The content of this provisional application is hereby incorporated by reference in its entirety.

[0002]

[0002] The present invention relates to the field of endoscopic surgical tools.

Background Art

[0003]

[0003] Suturing is a common approach for the repair of living tissues and is used for tissue closure, approximation, ligation, tissue access sites, organs, fixation of blood vessels, fixation of meshes and other grafts or devices, etc. Although greatly dependent on the skills of a surgeon or an endoscopist, the results obtained using suturing are sufficiently predictable and reliable.

[0004]

[0004] Alternatives to suturing that have been developed over the years, such as clips, staples, fasteners (also known as "temporary fasteners"), anchors, and tissue adhesives, are to some extent accepted and are used for tissue repair in both open and minimally invasive procedures, such as laparoscopy and flexible gastrointestinal (GI) endoscopy procedures.

[0005]

[0005] While manual suturing remains central to surgical repair, it is not without drawbacks. Manually forming a large number of stitches is tiring and time-consuming, and there is a possibility of suture errors that can compromise the integrity of the repair. In fact, in many procedures, the time taken for suturing can be longer than the time taken to treat the underlying target tissue. In endoscopic procedures, manual suturing is almost impossible, but the various commercially available suture-assist devices are cumbersome and tend to be difficult to use. Even robotic surgical platforms that can suture extremely precisely and delicately are usually limited by the speed at which the remotely operating surgeon can manipulate the handles of the robotic platform.

[0006]

[0006] The foregoing examples of the related art and the constraints associated therewith are intended to be illustrative and not exclusive. Other constraints of the related art will become apparent to those of ordinary skill in the art upon reading this specification and examining the drawings.

Summary of the Invention

[0007]

[0007] The following embodiments and aspects thereof are described and illustrated in connection with systems, tools, and methods that are intended to be illustrative and not limiting in scope.

[0008]

[0008] Some embodiments are directed to an apparatus for suturing tissue. The apparatus includes a flexible elongate shaft configured to be inserted into an endoscopic working channel, a handle disposed at a proximal end of the elongate shaft, a plurality of anchors disposed in a row within the elongate shaft, each of the plurality of anchors including an elongate body and an extension emerging outwardly from the elongate body, a thread disposed along a length of the elongate shaft and sequentially passed through extensions of the anchors, a grasping mechanism operable by the handle and configured to secure tissue to the apparatus during deployment of the anchors, and an anchor deployment mechanism operable by the handle and configured to penetrate tissue with a needle disposed within or on the elongate shaft and deploy the anchors one by one from the elongate shaft or the needle into a space on the opposite side of the tissue such that a longitudinal dimension of each deployed anchor is coplanar with a surface of the tissue when tension is applied to the thread.

[0009]

[0009] In some embodiments, the grasping mechanism includes a plurality of sharp elements configured to axially penetrate tissue or a helix configured to be inserted into tissue.

[0010]

[0010] Some embodiments are directed to an apparatus for suturing tissue. The apparatus is configured to grasp tissue from a first side of the tissue, deploy a plurality of anchors on an opposite side of the tissue, and optionally securely fix a thread passed through the anchors and disposed mostly on the first side of the tissue.

[0011]

[0011] Some embodiments are directed to a method for minimally invasive full - layer suturing.

[0012]

[0012] Some embodiments are directed to a method for minimally invasive gastrointestinal surgery.

[0013]

[0013] In some embodiments, there is provided an apparatus comprising a tubular grasper including an elastic tip configured to expand outward when not biased, a needle disposed within the tubular grasper and configured to penetrate tissue, a tubular anchor disposed over the needle, and a surgical thread passed through the tubular anchor.

[0014]

[0014] In some embodiments, a) inserting a flexible endoscope including a working channel having a distal opening into a body opening of a patient; b) providing a tubular grasper including an elastic tip configured to expand outward when not biased; c) exposing the tubular grasper from the distal opening of the working channel and releasing the bias of the tip so that the tip penetrates and secures tissue as the tip expands outward; d) providing a needle disposed within the tubular grasper and a tubular anchor disposed and secured over the needle, the tubular anchor through which a surgical thread is passed; e) pulling the tubular grasper proximally such that the secured tissue forms a sleeve and the tissue is pierced by the needle and the tubular anchor reaches the distal side of the tissue while fixed to the needle; f) pulling the needle proximally and releasing the tubular anchor from the flexible needle on the distal side of the tissue within the formed sleeve; g) biasing the tip such that the tissue is released from the tip of the tubular grasper; h) loading a new tubular anchor onto the flexible needle and repeating steps c, e, f, and g for the new tubular anchor; i) applying tension to the surgical thread to form a suture extending between the tubular anchor and the new tubular anchor; and j) securing the surgical thread to the new tubular anchor such that the tension is maintained. A method is provided that includes these steps.

[0015]

[0015] In some embodiments, the device further comprises one or more actuators. The actuator is configured to push the tubular gripper distally from the distal end of the endoscope so that the tip expands outward, penetrates the tissue, and secures the tissue to the gripper, and to pull the gripper proximally so that the tissue secured to the gripper is pulled proximally while the needle and the tubular anchor penetrate the tissue to position the anchor on the distal side of the tissue, pull the flexible needle proximally, release the tubular anchor on the opposite side of the tissue, and apply tension to the surgical thread on the proximal side of the tissue so that the tubular anchor pulls the tissue proximally.

[0016]

[0016] In some embodiments, the one or more actuators are at least partially included within the handle.

[0017]

[0017] In some embodiments, the tubular anchor includes a tubular body and an elastic expansion portion configured to expand outward from the tubular body when not biased, and the expansion portion includes a ring through which the surgical thread is passed.

[0018]

[0018] In some embodiments, the device further comprises an inner shaft to which the tubular gripper is fixed and a flexible tubular outer shaft configured to accommodate the inner shaft.

[0019]

[0019] In some embodiments, the one or more actuators are at least partially included within the handle and the inner shaft extends to the handle.

[0020]

[0020] In some embodiments, the device further comprises a tubular gripper collector mounted on the outer shaft and configured to accommodate the tubular gripper.

[0021]

[0021] In some embodiments, each of the tips of the tubular gripper has a rounded edge.

[0022]

[0022] In some embodiments, the extension is cut from the wall of the tubular anchor.

[0023]

[0023] In some embodiments, the ratio of the length of the tubular body of the anchor to the length of the extension of the anchor is from 1:0.3 to 1:0.7.

[0024]

[0024] In some embodiments, the tubular body of the anchor has a chamfered distal edge to facilitate passing through tissue with a needle.

[0025]

[0025] In some embodiments, the tubular body of the anchor has an inclined distal edge to facilitate passing through tissue with a needle.

[0026]

[0026] In some embodiments, a tissue grasper is provided. The tissue grasper includes a tubular body made of an elastic material and having a plurality of tips configured to expand outward when not biased, a tube configured to house the tubular body and the tips and to bias the tips so that the tips take a tubular configuration, and an actuator configured to: a) push the tubular body against the tube so that the tips penetrate the tissue while expanding outward from the tube and secure the tissue to the tips, and b) pull the tubular body against the tube so that the tips enter the tube while releasing the tissue.

[0027]

[0027] In some embodiments, the elastic material is a superelastic metal alloy and the tips are normally trained to an expanded configuration.

[0028]

[0028] In some embodiments, the plurality of tips are from 3 to 8 tips.

[0029]

[0029] In some embodiments, the plurality of tips are from 4 to 7 tips.

[0030]

[0030] In some embodiments, the plurality of tips are from 5 to 6 tips.

[0031]

[0031] In some embodiments, each of the tips has a rounded leading edge.

[0032]

[0032] In addition to the exemplary aspects and embodiments described above, still other aspects and embodiments will become apparent by considering the following detailed description with reference to the drawings.

Brief Description of the Drawings

[0033]

[0033] Exemplary embodiments are shown in the figures referred to. The dimensions of the components and features shown in the figures are generally selected for convenience of presentation and clarity and are not necessarily to scale. The figures are listed below.

[0034]

Figure 1A-1B

[0034] A perspective view of an apparatus for suturing tissue is shown.

Figure 1C

[0035] A perspective view of an alternative apparatus for suturing tissue is shown.

Figure 2A-2B

[0036] A side view and a perspective view of the distal portion of the shaft with a gripper are shown.

Figure 2C-2F

[0037] A perspective view of an alternative configuration of gripping means arranged alongside a needle is shown.

Figure 3A-3H

[0038] Various views of various anchors are shown.

Figure 4

[0039] A cross-sectional view of two anchors attached to tissue is shown.

Figure 5

[0040] A cross-sectional view of the distal portion of an apparatus for suturing tissue disposed inside an endoscope is shown.

Figure 6A-6F

[0041] Cross-sectional views of multiple stages of deploying an anchor into tissue are shown.

Figure 7A-7B

[0042] A perspective view and a cross-sectional view of a guide shaft for advancing and deploying anchors and their extensions separately are shown.

Figure 8

[0043] A perspective view of the distal portion of an alternative device for suturing tissue, with a needle housed within a jaw-type gripper, is shown.

Figure 9

[0044] A perspective view of a slotted needle is shown.

Figure 10A-10B

[0045] A perspective view of a scroll functioning as a gripping means is shown.

Figure 11A-11B

[0046] An isometric view of the upper surface of two scrolls is shown.

Figure 12A-12B

[0047] A cross-sectional view of a sleeve device is shown.

Figure 12C

[0048] A perspective view of the distal portion of the sleeve device from FIGS. 12A to 12B is shown.

Figure 13A-13B

[0049] A perspective view of an anchor is shown.

Figure 13C-13D

[0050] A perspective view and a side view of another anchor are shown.

Figure 14A-14B

[0051] A perspective view of a typical extrusion operation performed using the ratchet mechanism of the sleeve device from FIGS. 12A to 12B is shown.

Figure 15A-15C

[0052] A shaft device used in conjunction with the sleeve device from FIGS. 12A to 14C is shown.

Figure 15D

[0053] A cross-sectional view of the sleeve device from FIGS. 12A to 12B in conjunction with the shaft device from FIGS. 15A to 15C is shown.

Figure 15E-15F

[0054] A perspective view of a gripper is shown.

Figure 15G

[0055] A cross-sectional view of the tip penetrating the stomach wall is shown.

Figure 15H-15M

[0056] Perspective views of six alternative configurations of a gripper are shown.

Figure 16A-16D

[0057] Cross-sectional views of four stages of embedding an anchor on the opposite side of tissue are shown.

Figure 17A

[0058] Photograph of an experiment on a pig performed using a grasping device with a tip.

Figure 17B

[0059] Photograph of another experiment on a pig using a grasping device with a tip.

Figure 18A-18B

[0060] Perspective and cross-sectional views of the distal area of alternative shaft devices are shown respectively.

Figure 19A-19C

[0061] Side and two perspective views of alternative graspers in a closed configuration are shown respectively.

Figure 20A-20C

[0062] Side and two perspective views of alternative graspers in an open configuration are shown respectively.

Figure 21A

[0063] Top and side views of the distal area of one of the tips of alternative graspers are shown respectively.

Figure 21C

[0064] A side view of one of the tips of an alternative grasper in an enlarged state is shown.

Figure 22

[0065] A plan view of the sheet material from which the alternative grasper is manufactured is shown.

Figure 23A-23C

[0066] Side, front, and enlarged views of a needle are shown.

Figure 24

[0067] A flowchart of a method for suturing tissue is shown.

Figure 25A-25D

[0068] A side view of an alternative anchor in a closed configuration is shown.

Figure 26A-26C

[0069] A side view of an alternative anchor in an open configuration is shown.

Figure 27

[0070] A side view of another anchor in an open configuration is shown.

Mode for Carrying Out the Invention

[0035]

[0071] Disclosed herein are an apparatus for suturing tissue via a flexible endoscope and a method for suturing tissue invasively using the apparatus. The apparatus can be used for various endoscopic procedures that require full-thickness suturing of soft tissue for tissue closure, apposition, fixation, plication, and / or ligation.

[0036]

[0072] For example, the apparatus can be used to perform various upper and lower GI (gastrointestinal) procedures invasively, i.e., from an esophageal or rectal approach, via a gastric camera or colonoscope. Exemplary procedures include original or modified sleeve gastrectomy, fistula closure, endoscopic submucosal dissection (ESD), endoscopic mucosal resection (EMR), peroral endoscopic myotomy (POEM), gastric bypass modification, stent or other prosthesis fixation, closure or prevention of perforation, hemostasis or prevention of bleeding, lumen apposition, and others.

[0037]

[0073] Advantageously, the relevant part of the apparatus is sized to fit within a single working channel (also referred to as a "working channel", "instrument channel", etc.) of the endoscope, so that one or more other working channels can be made available for other tools required during the procedure, such as various imaging, lighting, suction, washing, and / or tissue manipulation tools. The working channel can have an inner diameter of, for example, 2 to 8 millimeters (mm), and the apparatus can have a relevant part (e.g., the outermost shaft) sized and configured to fit within that space.

[0038]

[0074] Advantageously, the device can deploy a plurality of anchors through a suture (also referred to as a "thread"). The device, the anchors, and the suture are all configured to (a) prevent or mitigate frictional damage to the surrounding tissue, (b) be able to close and / or approach the tissue by simply pulling the suture after satisfactorily deploying the anchors, (c) enable strong tissue fixation, (d) reduce the risk of tissue trauma and "cheese cutting" of the suture by reducing the tension on the sutured tissue (compared to conventional manual suturing), (e) not form a loop that encloses the tissue, thereby reducing the risk of nerve or blood vessel constriction, (f) perform standardized suturing, thereby reducing the variation among surgeons / endoscopists of various skill levels, (g) distribute the suture tension across all the anchors, (h) concentrate the force applied to the tissue at the interface between the tissue and each anchor, which has a significantly larger surface area than a surgical thread (also simply referred to as a "suture"), and / or (i) be configured to enable simple suturing actuated by an actuator with minimal expertise required even at remote anatomical locations.

[0039]

[0075] In the following description, even when the terms "method" and "step" are not explicitly stated, the described functions and uses of the various components constitute a method for suturing tissue.

[0040]

[0076] Referring now to FIGS. 1A and 1B, which show perspective views of a device 100 for suturing tissue according to one embodiment. The device 100 can include a handle 102 and a flexible shaft 104 extending from the distal end of the handle.

[0041]

[0077] The shaft 104 can be a flexible, elongated tube made of, for example, plastic and / or braided metal. The shaft 104 can have a length of, for example, 200 to 3000 mm, and a portion of this length, for example, 10 to 300 mm, can be disposed inside the handle 102. The shaft 104 can have an outer diameter of, for example, 2 to 10 mm. The shaft 104 can have a uniform or variable diameter along its length.

[0042]

[0078] A needle 108 can be disposed inside the shaft 104, and the needle 108 optionally has an inclined edge 110. Alternatively, the needle (not shown) can have a straight non-inclined edge. In the view of FIG. 1B, the needle 108 is shown protruding distally from the shaft 104. The needle 108 can be used to penetrate tissue in order to deploy an anchor on the opposite side of the tissue. The needle 108 can have an outer diameter of, for example, 0.5 to 9.8 mm and a wall thickness of, for example, 0.1 to 0.6 mm. The needle 108 can be made of stainless steel or any other suitable material such as nitinol (nickel-titanium alloy). Optionally, the needle 108 has an internal anchor stopper (not shown) near the distal end (e.g., 1 to 20 mm from the distal end), which is embodied as an elastic protrusion from the inner wall of the needle into the lumen of the needle, so that the inner diameter of the needle is smaller at that position. The stopper can normally protrude into the lumen of the needle 108, but can be fully or partially pushed out of the lumen when an anchor (discussed further below) applies a sufficient amount of force to it. The stopper can be configured to resist a predetermined amount of force.

[0043]

[0079] Referring temporarily to FIG. 9, an optional embodiment of a needle 900 having a slit 902 at the distal end is shown. The slit 902 can be configured to accommodate the suture 118 when the device moves from one anchor deployment position to another, and can prevent the suture from being cut when the suture rubs against the distal end of the needle. The slit 902 can be configured to have a smooth edge that does not cut the suture when the suture rubs against the edge. In contrast, the distal end of a needle without a slit, such as the needle 108 in FIGS. 1A to 1B, can include a sharp edge that can cut the suture. The slit 902 can have a length of, for example, 1 to 30 mm and a width of, for example, 0.4 to 2 mm.

[0044]

[0080] Returning from FIGS. 1A to 1B, inside the shaft 104, for example, a gripper 120 can also be disposed on the needle 108, and the gripper 120 can be used to grip tissue during tissue puncture by the needle and deployment of the anchor. Attempting to pierce tissue with only the needle without such gripping means, especially if the tissue is extremely soft, flexible, or swaying violently, may actually push the tissue away from the needle. The needle may eventually pierce the tissue, but that may be after the needle has extended significantly distally and risked damaging an unintended organ, blood vessel, nerve, or other tissue. Thus, it is beneficial to grip the tissue with the gripper and fix it to the shaft 104 while piercing the tissue.

[0045]

[0081] Optionally, the gripper 120 and the shaft 104 are configured to move distally or proximally on or inside the needle 108. Since the needle 108 can optionally be fixed relative to the handle 102, once the gripper 120 has gripped the tissue, the gripper can be retracted rearward relative to the needle, while the needle is held in place at the same position and distance from the tissue (and from any blood vessel, nerve, or other organ), thereby enabling safe tissue piercing.

[0046]

[0082] Optionally, the shaft 104 extends over and can cover the needle 108 and / or the gripper 120, while being inside an endoscope or an anatomical cavity and being able to protect the endoscope or the anatomical cavity from damage or injury. The shaft 104 can be made of plastic, metal, and / or metal alloy and can be configured to have sufficient flexibility along its longitudinal axis to conform to bending of the endoscope housing it.

[0047]

[0083] In the view of FIG. 1B, the grasper 120 is shown protruding distally from the shaft 104. The grasper 120 is configured as a tube that separates into a plurality of sharp grasping tips (e.g., 2 to 10 or more tips) that penetrate tissue at the distal portion. The grasper 120 is made of a shape memory alloy such as nitinol, and the grasping tips can be trained to a flared configuration that curves away from the central axis of the grasper and optionally also curves rearward. While the grasper 120 is inside the shaft 104, the grasping tips are biased to a contracted configuration that lies flat around the needle 108. When the grasper 120 is ejected distally and the grasping tips exit the distal end of the shaft 104, the grasping tips flare outward and penetrate the tissue facing the distal end of the shaft.

[0048]

[0084] FIG. 1C is a variation of the device 100 (from FIGS. 1A to 1B) and shows a device 100a with a differently configured handle 102a. The handle 102a can include various actuators such as a trigger 102b, a dial 102c, and a slide button 102d, which are configured to control various functions of the device 100a, such as the operation of the shaft, needle, grasper, anchor ejector, etc. However, the term "actuator" should not be construed as limited to such elements on the handle 102a, and an actuator can be any physical device connected to and configured to move and / or maintain in a stationary state one or more parts of a device (but not limited to, such as device 100a, etc.), such as a shaft, needle, grasper, anchor, ejector, inner shaft, outer shaft.

[0049]

[0085] Referring to FIGS. 2A through 2B, a schematic view of the distal portion of the shaft 104 according to an alternative embodiment of the gripper configured as the helix 120a is shown. The helix 120a can be attached to, connected to, or integrally formed with the distal end of a hollow expandable shaft 140 that is capable of rotatably pushing the helix into tissue and retracting the helix out of the tissue. That is, by screwing the helix 120a into the tissue 130, the shaft 104 can be fixed to the tissue. In FIG. 2A, the helix 120a is shown extending from the distal end of the shaft 104 (and the needle 108, not shown, is retracted inside the expandable shaft 140), which is a configuration where the helix has already been screwed into the tissue 130. In FIG. 2B, the needle 108 is shown extending through the helix 120a and out the other side, which is a configuration where the anchor is deployed from the opening of the needle on the opposite side of the tissue.

[0050]

[0086] The helix 120a is shown as having approximately three rotations (i.e., approximately 1080 degrees) around the central axis of the helix, although alternative helices (not shown) can have any number between one-quarter rotation (90 degrees) and 20 rotations. Also, although the helix 120a is shown as a single helix, alternative helices (not shown) can be double or triple helices wound around the same central axis.

[0051]

[0087] Referring to FIGS. 2C through 2F, an alternative configuration of gripping means disposed (not on the needle but) alongside the needle inside the shaft 104 is schematically shown.

[0052]

[0088] In FIG. 2C, a single helix is shown alongside the needle.

[0053]

[0089] In FIG. 2D, two helices are shown alongside the needle.

[0054]

[0090] In FIG. 2E, an expandable helix is shown alongside the needle. This helix can be made of, for example, a shape memory alloy (such as Nitinol) and trained to have a diameter larger than the radial space occupied next to the needle inside the shaft 104. When the helix exits the shaft 104, it expands to a large diameter and can thus grip tissue better than, for example, the helix in FIG. 2C (assuming the shaft and the needle are of the same size). Optionally, as this helix gradually advances out of the shaft 104 and is inserted into the tissue at the same time, the tissue can be gradually stretched during this insertion. The advantages of stretching the tissue in addition to gripping the tissue will be considered below with reference to the spiral-shaped gripper.

[0055]

[0091] In FIG. 2F, a gripper configured with a tip similar to the gripper 120 is shown alongside the needle.

[0056]

[0092] Optionally, the device 100 includes a helical protective sleeve (not shown) configured as a tube inside the shaft 104 but around the helix 120a. This sleeve can advance distally and cover the segment of the helix 120a that extends beyond the needle 108 (e.g., beyond its proximal inclined end) but is not within the tissue. Since this segment is likely to cause entanglement of the suture 118 between the turns of the helix, the sleeve acts to physically separate the suture and the helix and eliminate or reduce the possibility of entanglement.

[0057]

[0093] Any of the helices discussed above can be made of, for example, metal, metal alloy, or plastic and configured to be strong enough to be passed into the tissue without breakage or significant plastic deformation.

[0058]

[0094] Referring to FIG. 10A, yet another embodiment of a gripper configured as a scroll 1000 is shown. The scroll 1000 has a basic tubular shape, with an inner diameter configured to allow the scroll to be mounted on the needle 108 and an outer diameter configured to allow it to be disposed inside the shaft 104. The tube wall of the scroll 1000 can include a plurality of cutouts (such as three cutouts as shown in this example), which extend generally downward from the upper end of the tube wall, and between them form spiral pointed lobes such as three lobes 1000a - 1000c. A greater number of lobes are possible, such as from 2 to 7 lobes for example. Each cutout is proximal and can optionally terminate in a circular smooth end 1002. This end 1002 is configured to accommodate a suture without cutting it (in the event that a suture accidentally passes between the lobes during any of the procedures).

[0059]

[0095] The left side of FIG. 10A shows the scroll 1000 in a retracted configuration where the lobes 1000a - 1000c define a substantially uniform tubular shape, and the right side of the figure shows the scroll 1000 in an expanded configuration where the lobes project radially. The scroll 1000 is made of a shape memory alloy (such as Nitinol) trained to the expanded configuration and biased to the retracted configuration while the scroll is inside the shaft 104 and is able to expand when the bias is removed, i.e., when it exits the shaft.

[0060]

[0096] During operation, the shaft 104 can be brought into contact with or proximate to the tissue, and then pushed distally while rotating the scroll 1000. Next, the sharp edges of the lobes 1000a - 1000c pierce the tissue, and as these lobes continue to expand and rotate, they gradually stretch the tissue. That is, the scroll 1000 can perform both tissue grasping and stretching. As the tissue stretches, the tissue becomes thinner within the stretched area, so the distal movement required of the needle 108 to completely penetrate the tissue thickness can be reduced. Further, when the tissue is stretched from two or more points (the sharp edges of the lobes), it tends to remain substantially parallel to these points and thus substantially parallel to the distal opening of the shaft 104. This ensures that the needle 108 can penetrate the tissue substantially perpendicularly to the tissue, reducing the risk that the needle approaches the tissue at an obtuse angle and does not fully penetrate or does not penetrate the tissue at all. Also, this can contribute to reducing the force required to push the needle to pierce the tissue and / or allowing the use of a less sharp needle when the pushing force is the same (thereby reducing the risk of damaging other organs or tissue with the sharp end of the needle).

[0061]

[0097] After deployment of the anchor and retraction of the needle, the tissue can be released by pulling the scroll 1000 into the shaft while rotating it in the opposite direction. Thereby, the tissue gradually returns to a stationary state, and finally the sharp edges of the lobes 1000a - 1000c move away from the tissue. Alternatively, the needle 108 can remain stationary and the scroll 1000 advances distally over the needle from the shaft 104. The scroll 1000 can be rotated to release from the tissue as described above and retracted into the shaft 104. During retraction, the lobes gradually return to a stored configuration and together generally assume a tubular shape.

[0062]

[0098] Referring now to FIG. 10B, an alternative scroll 1010 is shown in which the cut-out portion of the tubular body has a different shape than in FIG. 10A, and thus forms a leaf-like portion with a different shape and sharp tip. This is generally intended to illustrate that a scroll-type gripper can be configured using such leaf-like portions that allow a desired level of tissue penetration and tissue stretching in response to pushing and rotating the scroll distally by a desired amount. For example, the pitch angle of the helical upper area of the leaf-like portion can affect the trade-off between tissue penetration and the required rotation. That is, a small pitch angle generally penetrates the tissue at an obtuse angle and grips the tissue more strongly for a particular penetration depth, but requires a large rotation to achieve that depth. In contrast, a large pitch angle generally penetrates the tissue at an acute angle, the strength of gripping the tissue for that particular penetration depth decreases, and the rotation required to achieve that depth becomes smaller. As another example, the radially expanding range of the leaf-like portion when not biased can affect the amount of tissue stretch that occurs for a particular length of pushing the scroll distally. That is, generally, a larger radial expansion results in a smaller distal push to achieve the same level of stretch. There is also an interrelationship between the radially expanding range of the leaf-like portion when not biased and the pitch angle of the helical upper area of the leaf-like portion.

[0063]

[0099] Generally, the pitch angle and / or the radial expansion can be adapted to the current suturing task, such as the thickness, flexibility, and resistance of the associated tissue to be penetrated.

[0064]

[0100] Referring now to FIGS. 11A through 11B, an isometric top view of an enlarged configuration of scroll 1010 and a different scroll 1020 is shown, and various parameters of possible embodiments of the scroll are illustrated. For purposes of illustration, the base portions of these two scrolls have the same inner diameter. However, their leaf-like portions are configured differently, which affects the way the leaf-like portions are inserted into the tissue to stretch the tissue.

[0065]

[0101] First, the lobes can expand to a specific overall diameter when expanded. This overall diameter is larger for the spiral 1010 and smaller for the spiral 1020. This expanded diameter can be obtained from the training of the shape memory alloy and / or from the shape in which the lobes are cut. The expanded diameter can affect the amount of stretch that occurs in the tissue, but as will be further explained below, it is not the only parameter related to stretch.

[0066]

[0102] Second, the orientation of the expanded lobes can define the circular diameter of the lobes inserted into the tissue. In FIG. 11B, the lobes of the spiral 1020 both have a substantially circular shape and define an insertion diameter that is substantially the same as the expanded diameter of the lobes. As the spiral 1020 expands gradually while being inserted into the tissue, it can gradually stretch the tissue as it attempts to assume its un-energized expanded diameter. However, in FIG. 11A, the lobes of the spiral 1010 curve inward from the expanded diameter at the edges, each forming its own small insertion diameter. When this spiral 1010 is inserted into the tissue while expanding, the tissue stretch may be different from that achieved with the spiral 1020.

[0067]

[0103] Another relevant parameter can be the wall thickness of the spiral along at least the region trained to bend. This parameter can affect the expansion force applied by the spiral. Generally, a thicker wall of a shape memory alloy spiral gives a greater expansion force to the spiral, and vice versa. This can then affect the amount of tissue stretch that the spiral can achieve.

[0068]

[0104] Thus, different spiral embodiments can each have different combinations of such parameters. All such possible combinations are explicitly intended herein.

[0069]

[0105] The diameter of the base portion may be, for example, 0.5 to 15 mm. The enlarged diameter may be, for example, 0.8 to 30 mm. The individual leaf-shaped portion insertion diameter, if different from the enlarged diameter, may be, for example, 0.5 to 29 mm. The wall thickness along at least the region of the spiral (optionally along the entire spiral) trained to be bent may be, for example, 0.1 to 4 mm.

[0070]

[0106] Throughout the present disclosure, general references to the "grasper" or "grasper 120" are intended, with no change, to also represent the helix 120a or the spiral 1000 / 1010.

[0071]

[0107] Terms such as "push", "pull", "advance", etc. are used herein to describe the relative movement of two or more parts of the device. For example, when the needle is described as being "advanced", the needle can be physically manipulated to move forward relative to the handle, or the needle can remain stationary relative to the handle while one or more other parts of the device are retracted rearward relative to the needle so that the needle can be in a more forward position. The same principle applies to other parts of the device.

[0072]

[0108] Returning to FIGS. 1A-1C, the handle 102 may include one or more user-actuable actuators such as, but not limited to, one or more triggers 106a and / or 106b and a button 106c. These user-actuable actuators are configured and function to operate the shaft 104, the needle 108, the gripper 120, and / or may be configured to deploy an anchor. For example, using the trigger 106a, the gripper 120 can be extruded from the distal end of the shaft and engaged with tissue. Using the button 106c, the needle 108 can be advanced to penetrate the tissue while the gripper 120 is retracted into the shaft 104. Using the trigger 106b, the anchors can be extruded one at a time from the distal end of the needle 108. For example, each time the trigger 106b is fully pulled rearward, a row of anchors can be pushed a length equal to (or similar length to) one anchor. These are merely examples of the functions of user-actuable actuators included with the handle. In other embodiments, the various user-actuable actuators may be configured differently.

[0073]

[0109] A plurality of anchors can be arranged in a row inside the needle 108 (or on top of the needle in a configuration not shown in the figures). Optionally, a spacer can be placed between two adjacent anchors to ensure that when one anchor is withdrawn from the needle 108, the subsequent anchor does not protrude from the distal end of the needle. The spacer may or may not pass through the suture 118. The spacer can be made of a bioabsorbable material so that it is absorbed and consumed within the body. Alternatively, if the suturing operation is of the gastrointestinal tract, the device can be configured such that after deployment of the anchor, the spacer remains in the lumen of the esophagus, stomach, or intestine and is later naturally excreted from the body along with other feces. Optionally, the spacer can help prevent the ejected anchor from inadvertently retracting back into the needle 108.

[0074]

[0110] FIGS. 3A-3H illustrate exemplary anchors 112a-112d (hereinafter collectively referred to as "anchor 112"). FIG. 3A shows a first exemplary anchor 112a. FIG. 3B shows a second exemplary anchor 112b. FIGS. 3C-3E show a third exemplary anchor 112c in an exploded view, an enlarged configuration, and a stored configuration. FIGS. 3F-3H show a fourth exemplary anchor 112c in an enlarged configuration, a stored configuration, and a bottom view of the enlarged configuration.

[0075]

[0111] Each of the anchors 112 may have an elongated body 113a-113c made of a rigid or flexible material such as stainless steel, nitinol, titanium, and / or a plastic such as polyetheretherketone (PEEK), which may be hollow or solid (permanent or bioabsorbable). The elongated body may have a maximum outer diameter of, for example, 0.5-5 mm and a length of, for example, 2-15 mm. In the case of a hollow body, the wall thickness may be, for example, 0.1-1 mm.

[0076]

[0112] A flexible or rigid extension may emerge from the anchor 112. As shown in FIGS. 3A-3B, the extension may be, for example, a cord 114a made of surgical thread (sometimes referred to as "surgical suture") or a flexible metal wire.

[0077]

[0113] As shown in FIGS. 3C-3H, the extension may be a flexible or rigid rod 114b-114c (linear, curved, spring coil, etc.) made of a suitable material such as one of the materials described for the anchor body.

[0078]

[0114] Also, any of the extensions 114a-114c may optionally be extensible along the longitudinal axis. Each of the extensions 114a-114c may have a circular or non-circular outer shape. Each of the extensions 114a-114c can be attached to, connected to, or integrally formed with the anchor 112. Each of the extensions 114a-114c may have a diameter or width (in some cases) of, for example, 0.1-2 mm, which may be uniform or variable along the length.

[0079]

[0115] Optionally, each of the extensions 114a - 114c is attached to, connected to, or formed as an elastic element integrally formed with the anchor 112 perpendicularly (or substantially perpendicularly, e.g., forming an angle of 60 degrees to 90 degrees with the anchor). Thus, when the anchor 112 is inside the receiving lumen (e.g., when passing the anchor through a needle, the needle 108 or the shaft 104), the extensions 114a - 114c are biased to be parallel or substantially parallel to the anchor (e.g., at 150 degrees to 180 degrees with respect to the longitudinal axis of the anchor), which can increase the friction between the cord and the inner wall of the needle and prevent the anchor from being accidentally pulled out of the device. Later, when the anchor 112 is pulled out of the needle 108, the extensions 114a - 114c take an unbiased vertical position. This position ensures that after tensioning and fixing the suture thread, the anchor 112 lies flat or substantially flat with respect to the distal side of the tissue.

[0080]

[0116] Alternatively, any of the extensions 114a - 114c is formed as a rigid element pivotally connected to the anchor 112, allowing the extension to rotate between an expanded configuration (standing perpendicularly or substantially perpendicularly from the anchor) and a retracted configuration (parallel or substantially parallel to the anchor).

[0081]

[0117] In FIGS. 3A - 3B, the bodies 113a of the anchors 112a - 112b are likewise hollow tubes with a circular outer shape. The cord 114a forms a loop outside the body 113a. Inside the body 113a, the two ends (not shown) of the cord 114a can be tied to the body or otherwise fastened together and / or separately fastened.

[0082]

[0118] Figure 3B shows anchor 112b, which is mostly similar to anchor 112a of Figure 3A but has optional features. That is, one or more elastic wings 115 are biased to be in the same plane as the anchor while it is inside the needle 108, but expand and enlarge once the anchor is withdrawn from the needle. Each elastic wing 115 may be a bow-shaped wire made of a superelastic material such as nitinol, or an elastic material such as stainless steel or cobalt-chromium alloy (CoCr). Alternatively, elastic wings may be formed integrally with the anchor, such as cutouts in the wall of the anchor trained to expand radially outward when not biased (not shown). The wings 115, when expanded, make the anchor 112b larger than the diameter of the needle 108 on at least one side, preventing the anchor 112d from retracting into the needle after being withdrawn from the needle. In some embodiments, the wings 115 can provide friction between the anchor 112b and the inner wall of the needle 108 to prevent the leading anchor 112b in the needle from being accidentally withdrawn. The wings 115 are shown with anchor 112b, which is otherwise similar to anchor 112a, but may be implemented with any of anchors 112b - 112d or any other anchor considered herein but not shown. Further, the functions of anchor expansion and / or anchor friction with the receiving lumen (e.g., the needle) after being withdrawn from the device may be realized differently from the wings shown. For example, this may be realized by at least one elastic expansion portion configured to be flat or substantially flat with respect to the anchor when biased and to expand to a distance of 0.5 - 5 mm from the anchor when withdrawn from the receiving lumen.

[0083]

[0119] From FIGS. 3C to 3E, the anchor 112c has a tubular body 113b, which has a longitudinal cutout from one end of the tubular body to approximately the middle of its length or slightly beyond the middle. A pair of protrusions at one end of the tab 114b fit into corresponding openings in the wall of the body 113b, whereby the tab is pivotally connected to the body. At or near the opposite end of the tab 114b, an opening is provided for passing the suture 118 through the tab. When the anchor 112c is disposed inside the needle 108, the tab 114b is stored and maintained entirely or partially inside the body 113b. After the anchor 112c is withdrawn from the needle 108, the tab 114b can rotate to assume a position perpendicular or substantially perpendicular to the body 113b. Optionally, the anchor 112c (or any of the other anchors) can include an extension locking mechanism (not shown) configured to lock the extension in a position perpendicular or substantially perpendicular to the body of the anchor. For example, this locking mechanism can be configured to automatically lock the extension once it reaches a perpendicular or substantially perpendicular position.

[0084]

[0120] From FIGS. 3F to 3H, the anchor 112d, unlike FIGS. 3C to 3E, has a tubular body 113b with a tab 114c cut from the tubular body itself. The rotation of this tab 114c is effected by bending the material of the tubular body 113b in the area where the tab starts. This bending may be plastic or elastic depending on the material from which the anchor 112d is made. At or near the opposite end of the tab 114c, an opening is provided for passing the suture 118 through the tab. The anchor 112d is made of, for example, a shape memory alloy (such as nitinol), and the tab 114c can be trained to bend into a position perpendicular or substantially perpendicular to the body 113b. Thus, the tab 114c can be biased into a stored configuration when inside the needle 108 and spring back into the trained position when withdrawn from the needle, thereby preventing the anchor 112d from being accidentally pulled back into the needle.

[0085]

[0121] In another configuration of the anchor (not shown), the extension may be realized by a single-strand cord that extends from the anchor body and has a ring tied or attached to the opposite end thereof.

[0086]

[0122] Optionally, any opening, ring, or loop of any of the anchors 112a-112d is smooth and has no sharp edges, so damage to both the suture 118 and the tissue due to friction with this opening, ring, or loop is prevented or reduced. Such smoothness can be achieved by appropriate surface treatment and / or by coating at least the inner surface of the opening, ring, or loop with a smooth material, optionally a polymer. Optionally, for any extension of any of the above-described anchors, an additional ring, such as the smooth ring 116 of the annular body shown by the dashed line in FIGS. 3A, 3D, and 3F, is connected. It is also possible to pass the suture 118 through the ring 116 instead of the extension, and the smoothness of the surface of the ring can further reduce friction and prevent damage to the suture. In an alternative configuration (not shown), the low-friction ring may have a different shape instead of being annular, but this different shape also has no sharp edges that could damage the suture.

[0087]

[0123] FIG. 4 shows two of the anchors 112a attached to the tissue 130, in a state where the cord 114a completely penetrates the tissue and connects the suture 118. The anchor 112a can be attached to the tissue 130 such that the cord 114a pierces the tissue and protrudes from the opposite side. The suture 118 passes through the loop of the cord 114a on the opposite side of the tissue 130, and when the suture is strongly pulled, the cord portion protruding from the tissue can bend to prevent damage to the tissue. The anchors 112b-112d in FIGS. 3B to 3H can function similarly.

[0088]

[0124] To dispense the anchors 112 one by one from the shaft 104, the device 100 may include an extrusion portion, such as a rod (not shown) disposed inside the needle 108 that extrudes a row of anchors from behind the most proximal anchor.

[0089]

[0125] As an alternative to pushing all the anchors 112 out simultaneously from the rear, to deploy the most distal anchor, the device 100 may include a different deployment section (not shown) configured to deploy only the most distal anchor. For example, such a deployment section may be disposed on (or within) a row of anchors without contacting all the anchors except the most distal anchor. Contact between the distal end of this deployment section and the most distal anchor is arranged to facilitate pushing that anchor distally by advancing the deployment section distally to a distance sufficient to deploy the anchor from the needle 108. The deployment section is then retracted rearward to enable deployment of the next anchor if desired.

[0090]

[0126] Referring again to FIGS. 1A through 1B, the suture 118, not seen in these figures, is disposed along its length within the needle 108 and may optionally exit from the distal end of the needle. The suture 118 can be sequentially passed through a ring or loop of anchors disposed continuously within the needle 108. The suture 118 is optionally wound around a spool (not shown) disposed within the handle 102 in its proximal area.

[0091]

[0127] The suture 118 can be a surgical suture, optionally absorbable or non - absorbable in the body (and sometimes referred to as a “surgical stitch”). Suitable absorbable materials include, for example, polyglycolic acid, polylactic acid, monocryl, and polydioxanone. Suitable non - absorbable materials include, for example, nylon, polyester, PVDF (polyvinylidene fluoride), and polypropylene. The suture 118 can be a braided suture, a monofilament suture, or a multifilament suture. The suture 118 can be made of metal or plastic, or any biocompatible material. The suture 118 can be stretchable or substantially non - stretchable.

[0092]

[0128] The suture 118 is optionally fixed at one end to a spool of the handle and continuously extends therefrom through all of the loops or rings of the anchors. The other end of the suture 118 can remain unfixed or can be attached to the most distal anchor (e.g., using a knot, an adhesive, a fastener, etc.). The latter means that after deploying a series of anchors, the suture 118 can be cut at a position proximal to the last deployed anchor, and to tightly tighten the suture extending through the deployed anchors, only the new proximal end of the suture 118 needs to be pulled. Then, the new proximal end can be fixed to the last deployed anchor using a manually tied knot or a fastener to prevent the suture from sliding through the ring or loop of that anchor.

[0093]

[0129] Optionally, the attachment of the suture 118 to the most distal anchor can be made unidirectional, for example, by making a large knot of the suture distal to that anchor so that the anchor can only slide proximally and not distally. Further optionally, after deploying two or more anchors, cutting the suture, applying tension and fixing it, preparations for another suturing operation of the device 100 can be made (assuming that at least two anchors remain in the device). This preparation is done by making a knot of the suture distal to the most distal anchor inside the shaft 104 at this point (of course, the suture remains inside the device), making it possible to apply tension and fix it in the same manner as described above.

[0094]

[0130] Optionally, the device 100 includes a suture cutting mechanism such as a sharp blade (not shown) for cutting the suture 118 at a position proximal to the last deployed anchor.

[0095]

[0131] Advantageously, the suture passes through a ring or loop that is separated from the anchor body and not embedded in the tissue, rather than through the anchor body itself, thereby preventing the suture from applying force to the tissue. If the suture applies force to the tissue, in extreme cases, it may cut the tissue.

[0096]

[0132] Further, when tension is applied to the suture to completely close the tissue, the separation of the ring or loop from the anchor body reduces the stress from the anchor body, causing the stress to concentrate on the ring or loop and the stress along the cord to be minimal.

[0097]

[0133] Further, the use of the anchor means that the embedded surface area is increased, which can resist the force attempting to pull the anchor out of the tissue. If only sutures were used, the surface area for fixing the suture would be only the suture itself, which is extremely small. In particular, mucosal tissue (such as that of the stomach) is known to be difficult to suture and is usually not well retained by sutures or clips. Also, suturing such high-tension tissue often slices the tissue, and even when the tissue somehow maintains its integrity, the sutures can sometimes cause ischemia and necrosis. Therefore, by using this anchor to suture mucosal tissue (and other types of soft and fragile tissues), these problems can be overcome, enabling highly durable tissue closure and contact without damaging the tissue. On one side of the tissue, the side wall of the anchor contacts the tissue along the longitudinal dimension of the anchor, spreading the applied force over a large area. On the opposite side of the tissue, the force pulling the anchor towards the tissue is dispersed across the entire suture connecting all the rings or loops of the anchor. Further, tightening the suture is performed outside the soft tissue, i.e., in an environment without friction, through a ring or loop with a smooth inner surface, and the friction with the suture is extremely small. For this reason, even during the patient's recovery period, the suture occasionally rubbing against the surface of the ring or loop will not cause degradation such as the suture tearing.

[0098]

[0134] After embedding all the anchors and applying tension to the suture, the suture can be manually knotted and tied or fixed with a fastener (not shown). If both ends of the suture are free after embedding, the fastener used is a connector mounted on the two suture portions (or passing these suture portions through the fastener), preventing these portions from moving relative to each other. If the distal end of the suture is already fixed to the initially embedded anchor and only the proximal end of the suture remains free, the fastener used can be a device that is mounted on the suture by friction and pressed against the ring of the last embedded anchor.

[0099]

[0135] Placing the fastener on two suture portions or one suture portion can be performed using a separate tool manipulated by a surgeon (through an endoscope) or by the function of the device itself actuated from a handle. The fastener is optionally unidirectional, i.e., it can slide only distally but not proximally once mounted on one or more suture portions. Thus, the sliding of the fastener helps to apply tension to the suture and ensures that the tension cannot be accidentally loosened.

[0100]

[0136] Referring now to FIG. 5, a schematic cross-sectional view of the distal portion of the device 100 in which the shaft 104 is disposed inside the working channel 502 of the endoscope 500 is shown. According to one embodiment, one of the other channels 504 of the endoscope 500 optionally functions as a suction lumen. In that embodiment, a suction cup 506 is mounted on the distal portion of the endoscope 500 to expand the tissue area to be suctioned into the space 508 of the suction cup. When suction is activated, the tissue is pulled into the space 508 and towards the distal end of the shaft 104. The distal opening of the suction cup 506 can have a diameter of, for example, 10 - 30 mm. The effective depth of the suction cup 506 (i.e., the distance between its distal opening and the distal end of the endoscope 500) can be, for example, 3 - 20 mm. The volume of the space 508 can be, for example, 1 - 40 cc (cubic centimeters).

[0101]

[0137] Optionally, aspiration can also be used to separate tissue from adjacent tissue that may be damaged if the grasper 120 or the needle 108 accidentally penetrates the adjacent tissue. Optionally, once the aspiration lumen 504 has aspirated, the grasper 120 can be used to more firmly attach the shaft 104 to the tissue. Optionally, once the grasper 120 has fixed the tissue, aspiration can be turned off until the next use. Optionally, aspiration can be actuated by a controller (not shown) configured on the handle 102, or a foot-operated switch (not shown), etc.

[0102]

[0138] As an alternative to the aspiration lumen 504, the shaft 104 or the needle 108 itself may function as an aspiration lumen. That is, the shaft 104 or the needle 108 may be connected to an aspiration source proximally to enable tissue aspiration distally.

[0103]

[0139] In other embodiments, the working channel 504 is not used for tissue aspiration and the aspiration cup 506 is absent. Instead, the working channel 504 (and optionally one or more additional working channels) can be used to insert, for example, a camera, a illuminator, an optical fiber, and / or a surgical tool.

[0104]

[0140] Referring now to FIGS. 6A through 6E, cross-sectional views of multiple stages of deploying the anchor 112 into the tissue 130 using the device 100 of FIGS. 1A through 1B are shown in accordance with one embodiment. For simplicity of explanation, the endoscope into which the shaft 104 is inserted is not shown in these figures.

[0105]

[0141] The distal end of the shaft 104 of the device can approach and contact the tissue 130 (FIG. 6A). For this reason, an endoscope (not shown) can be held in place while pushing the shaft 104 slightly outward of the endoscope. When the shaft 104 is aligned with the tissue, the gripper 120 can be extended outside the shaft 104 to penetrate the tissue 130 (FIG. 6B). Next, the needle 108 is extended outside the shaft 104 through the fixed tissue 130 (FIG. 6C). Then, the anchor 112 can be deployed through the needle 108 to the opposite side of the tissue 130 (FIG. 6D). Finally, the gripper 120 and the needle 108 are retracted into the shaft 104 and the device is moved rearward (FIG. 6E), leaving the anchor inside the tissue 130.

[0106]

[0142] In FIGS. 6A-6E, the suture 118 is shown passing freely through the ring / loop of the most distal anchor. For this reason, after embedding a plurality of anchors required for the suturing task, it is necessary to pull both sides to tightly tighten the suture. In an alternative embodiment (not shown), the suture can be permanently attached to its ring / loop using, for example, a knot or a connector, so that all that is necessary to finally tighten the suture is to pull on its proximal side.

[0107]

[0143] An optional feature shown in FIGS. 6A-6E is a deflector 108a disposed at or near the opening of the needle 108. The deflector 108a may be a protrusion from the inner wall of the needle 108 intended to deflect an exiting anchor in the opposite direction. For example, if the deflector 108a is positioned on the upper side of the needle 108, this deflects each exiting anchor downward. This deflection inclines the exiting anchors with respect to the central axes of the needle 108 and the shaft 104, so that when they are retracted rearward, the anchors stay on the opposite side of the tissue without being retracted with them. The deflector 108a can be formed in a wedge shape such that the surface contacting the anchor forms an acute angle (e.g., 10-60 degrees) with the central axes of the needle 108 and the shaft 104. Also, the deflector 108a can function as the stopper described above.

[0108]

[0144] Figure 6F shows a variation of the use of device 100. In this variation, after the gripper 120 is fixed to the tissue 130, the device (or at least its shaft) is pulled proximally together with the fixed portion of the tissue. As a result, a space where no other tissue or organ may be present is created on the distal side of the tissue, so that these tissues / organs are not damaged even when the needle is extended and the anchor is deployed. For example, when suturing the gastric wall using device 100, after pulling the wall, the needle passing through the wall can reduce the possibility of the needle piercing one of the many blood vessels surrounding the stomach, pancreas, etc.

[0109]

[0145] As shown in FIGS. 6A to 6F, an example of the use of device 100 provided with gripper 120 (or gripper 120a) can be to perform endoscopic sleeve gastrectomy. For example, after initial marking along the greater curvature on the anterior and posterior walls of the stomach to provide guidelines for the suturing procedure, the shaft 104 of device 100 can be inserted into the patient's stomach with an endoscope. Then device 100 can deploy the first anchor at a distal position along the gastric wall where the sleeve is to begin, for example, the distal anterior or posterior wall. Optionally, device 100 can start suturing from that distal position of the stomach, for example, near the pylorus, and proceed in the proximal direction from there. Additional anchors can be attached to the anterior wall, greater curvature wall, and posterior wall of the stomach to create a desired suture pattern, for example, a triangular suture configuration. The suture pattern can be performed by attaching 2 to 6 anchors, for example, to create a fixation group. After performing 2 to 6 attachments, the suture can be tightly tied (or fixed by other means without tying). Alternatively, the suture can be tightly tied only after additional attachments along the greater curvature have been made. Some additional anchor attachments can be made towards the proximal end of the stomach along the guidelines, for example, by 4 to 10 fixation units, to perform a similar pattern and maximize the reduction of the gastric size.

[0110]

[0146] Another example of the use of the device 100 is to perform a modification of the treatment of gastric obesity after sleeve gastrectomy. Due to the expansion of the sleeve over time, a modification may be required. To perform the modification, a suture line can be executed within the stomach along the previous sleeve gastrectomy suture line to further reduce the volume of the stomach. The new suture line can extend along the new (after sleeve gastrectomy) greater curvature of the stomach.

[0111]

[0147] Another example of using the device 100 is for the modification of the outlet. In some examples, after performing a gastric bypass, the outlet expands and the effect of the bypass is reduced. To reduce this expansion, the outlet circumference of the gastric bypass outlet into the bypass tunnel can be reduced. The device 100 is used to suture the outlet. An anchor can be attached to the gastric wall at the outlet, and the suture can be tightened firmly to narrow the diameter of the outlet. This can be performed at multiple longitudinal positions along the expanded outlet.

[0112]

[0148] Another example of using the device can be to seal a perforation in the stomach, intestine, or any other luminal part of the gastrointestinal system. This procedure can be performed by attaching an anchor to the edge of the perforation. A second anchor can be attached to the edge on the opposite side of the perforation. Additional anchors can be attached to create a cross-stitch pattern across the perforation, for example, two or four additional sutures. After attaching the anchors, the sutures attached to the anchors are pulled to generate tension to seal the perforation.

[0113]

[0149] Figures 7A through 7B show internal guide shaft 700. This is optionally housed within needle 108 and includes two internal channels that each terminate at two openings 702 and 704 for advancing and deploying the anchors and their extensions separately. The two channels may be interconnected longitudinally (to facilitate the interconnection of each anchor with its cord), but allow a series of anchors 112 to move along one channel and a series of extensions 114 (and suture 118) to move separately along the other channel, separating these elements and preventing suture 118 from becoming entangled with anchors 112 and / or their extensions 114.

[0114]

[0150] Figure 8 shows the distal portion of an alternative device 800 for suturing tissue, with needle 108 housed within a jaw-type gripper. This gripper includes two (or more) jaws 802a and 802b that are configured such that needle 108 is positioned between them when closed. The base portions of jaws 802a and 802b, i.e., the locations where they connect to shaft 104a, include an opening to an elongated channel that extends inside the shaft to house needle 108. Needle 108 can move distally and proximally within that channel. For example, with needle 108 fully housed within the channel of shaft 104a, the distal portion of device 800 can first be advanced towards the tissue to be sutured. Next, jaws 802a and 802b are opened to surround a portion of the tissue and then closed over the tissue to grip it. Then, needle 108 is pushed distally through the channel to penetrate the tissue. Needle 108 is advanced distally until its distal opening reaches the opposite side of the tissue. Then, the anchor (shown by a phantom line inside needle 108) is pushed distally until the leading anchor is pulled out of the needle and reaches the space on the opposite side of the tissue. Finally,

[0115]

[0151] Needle 108 can be retracted into the channel of shaft 104a, jaws 802a and 802b can be opened, and the distal portion of device 800 can be repositioned to deploy the next anchor at a different location on the tissue.

[0116]

[0152] Optionally, the shaft 104a of this grasper may be housed inside an outer shaft such as the shaft 104 in the previous figures. Alternatively, the shaft 104a may be passed directly through the working channel of the endoscope.

[0117]

[0153] In any alternative configuration of the device for suturing tissue, the device may be configured for partial-thickness suturing rather than full-thickness suturing of soft tissue. In such a configuration, the needle may penetrate only a portion of the tissue thickness, and the anchor may be deployed inside (or partially inside) the tissue rather than on the opposite side of the tissue.

[0118]

[0154] Further, throughout most of the drawings, the shaft, needle, grasper, and grasper protection sleeve are shown with a substantially concentric outer shape, but one or more of them may be configured with an eccentric outer shape.

[0119]

[0155] Now, refer to FIG. 12A, which shows a cross-sectional view of the sleeve device 1200. The sleeve device 1200 may function as an alternative to the shaft (shown as 104 or 104a in other figures) described above, or may be disposed inside such a shaft to replace at least a portion of the internal components such as the anchor and suture. Also refer to FIG. 12B, which is an enlarged view of the distal portion of the sleeve device 1200 in FIG. 12A.

[0120]

[0156] Advantageously, the sleeve device 1200 can include an internal ratchet mechanism that enables pushing an anchor, such as anchor 1204, in one direction distally. The ratchet mechanism can include a push rod 1206 that extends longitudinally along the sleeve device 1200, and the push rod 1206 can have a plurality of ridges 1206a disposed (optionally equidistantly) along its length. Each such ridge 1206a can be connected to, attached to, or integrally formed with the push rod 1206 such that it is fixed thereto as the push rod moves. Each ridge 1206a is generally configured in a conical shape such that the wide side of the cone faces distally and the narrow side of the cone faces proximally. Thus, when the push rod 1206 is pushed distally or pulled proximally, the ridge 1206a moves with it. That is, when the push rod is pushed distally, each ridge thereby pushes each anchor 1204, and when the push rod is pulled in the proximal direction, each ridge passes through the anchor until positioned immediately behind each anchor and is ready for the next pushing operation. This will be further considered below.

[0121]

[0157] An alternative ratchet mechanism (not shown) can include a one-way expansion portion on each anchor. This can be, for example, fins extending outwardly and proximally from the anchor, and a series of mating ridges on a sleeve or other tube surrounding the anchor. For this reason, the anchor can move only forward (distally) within its tube and cannot return backward (proximally). Also, such a one-way expansion portion can help prevent the anchor from returning backward through the tissue opening after the anchor has been embedded on the opposite side of the tissue.

[0122]

[0158] The sleeve device 1200 can include a sleeve 1202 made of a flexible material such as polytetrafluoroethylene (PTFE, commercially known as Teflon®). The anchors 1204 can be positioned (optionally equidistantly) inside the sleeve 1202, and suture threads 1208 can be passed through them and disposed within the sleeve.

[0123]

[0159] The sleeve 1202 can be configured using a structure-weakening modification in each area where the anchor 1204 is to be disposed, so that when the push rod 1206 is stationary, the anchor is relatively fixed in these areas. These structure-weakening modifications are elongated slits such as the slit 1206b shown in FIG. 12B, for example, which can be seen more clearly in FIG. 12C, which is referred to temporarily below. FIG. 12C shows a perspective view of the distal portion of the sleeve 1202 corresponding to the distal portion shown in FIGS. 12A and 12B. As shown, the sleeve 1202 includes a slit 1206b along the area where the most distal anchor (not shown in this figure) is disposed. Each of the slits 1206b can have a length equal to ±25% of the length of each anchor. The slit 1206b weakens the structure of the sleeve 1202 and allows the diameter of the sleeve to expand slightly when an anchor is disposed in the area of the slit.

[0124]

[0160] Now, refer to FIGS. 13A and 13B, which show the anchor 1204 in more detail. In FIG. 13A, the anchor 1204 is shown with the extension 1204a in the same plane as the anchor body, and in FIG. 13B, the anchor is shown with its extension lifted vertically from the body.

[0125]

[0161] The anchor 1204 can be generally similar to the above-described anchor 112d (referring to FIGS. 3F to 3H), except for some differences. The anchor 1204 can have an elongated body and a flexible extension 1204a emerging therefrom, as previously considered for the anchor 112d. However, the anchor 1204 can include a proximal feature that can be pushed in one direction by the ratchet mechanism of the above-described sleeve device 1200. That is, the circumference of the hollow body of the anchor on the proximal side is not a complete circle and can be a pair (or multiple pairs) of concave elastic "legs" 1204b to 1204c facing each other, and the inner diameter defined between them (at the proximal end) can be slightly (e.g., 5 to 30%) smaller than the inner diameter of the remaining part of the anchor body. This small inner diameter is maintained as long as the legs 1204b to 1204c are in a resting state without being biased by any force. Referring also to FIG. 12B, the large diameter of the protrusion 1206a (on the distal side) is the same as (or slightly, e.g., 1 to 10% smaller than) the inner diameter of the area of the anchor 1204 without legs, but can be slightly larger than the inner diameter of the resting legs 1204b to 1204c. Thus, when the push rod 1206 is pushed distally, the distal edge of the protrusion 1206a engages the proximal edges of the legs 1204b to 1204c, moving the entire anchor 1204 distally. Conversely, when the push rod 1206 is pulled proximally backward through the anchor 1204, the small diameter on the proximal side of the protrusion 1206a slides through the area of the anchor 1204 without legs, and when it reaches the legs 1204b to 1204c, the legs are expanded outwardly and biased until the protrusion passes completely through them and is positioned just behind the anchor (i.e., just behind the proximal ends of the legs). Then, when the outward biasing of the legs 1204b to 1204c ends, they return to the resting state and are ready for another pushing operation.

[0126]

[0162] Optionally, legs 1204b - 1204c are configured to expand slightly outward (e.g., by thermal training) when not biased by any force. This can assist in preventing anchor 1204 from sliding rearward through the tissue opening when the push rod with the attached anchor (discussed below) is pulled rearward from the tissue by making the outer shape of the proximal end of the anchor significantly larger than the tissue opening.

[0127]

[0163] Also, legs 1204b - 1204c can be configured to have sufficient space therebetween such that a thread (passed through a series of anchors) can conveniently pass therethrough.

[0128]

[0164] Now, refer to FIGS. 13C - 13D, which respectively show another configuration of anchor 1205 in a perspective view and a side view. Anchor 1205 is similar to anchor 1204 except for the following differences. First, anchor 1205 can have fins on the lower side as discussed above. Second, the entire upper wall of anchor 1205 can be open except for the loop at the end of the flexible expansion portion. This allows the thread to pass more freely over the anchor when the anchor is within an encapsulation sleeve or other tube.

[0129]

[0165] Figures 14A and 14B illustrate a typical pushing operation performed using the ratchet mechanism of the sleeve device 1200. Figure 14A shows the most distal anchor 1204 in a designated area within the sleeve 1202 before pushing. Next, the push rod 1206 is pushed distally, and the ridge 1206a engages with the anchor 1204, also advancing it distally. When the anchor 1204 exits the sleeve 1202 (optionally, from another enclosed portion not shown here, such as a shaft, needle, or endoscope channel), the expansion portion 1204a is no longer biased and can rise. Next, when the push rod 1206 is pulled proximally, the ridge 1206a can pass through the next anchor in the row within the sleeve 1202. This anchor is hidden in Figure 14B and is located inside a slightly widened (weakened) area 1202c of the sleeve. Then, when the push rod 1206 is positioned immediately behind that anchor, another pushing operation can be performed, which continues until all the anchors inside the sleeve device 1200 are deployed.

[0130]

[0166] Note that Figures 12A through 14C do not show the grasping means or the needle because these elements may be the same as those described above with reference to other embodiments. For example, the sleeve device 1200 can be disposed inside such a needle and / or gripper that functions to pierce and grasp tissue as discussed above. Alternatively, the embodiments shown in Figures 12A through 14C may not require a needle surrounding the anchor. Instead, the optional sharp end 1206a of the push rod 1206 can be utilized to penetrate the tissue, and optionally, the distal edge 1204d of the optionally sharp beveled anchor 1204 can also be utilized, thereby further expanding the initial piercing performed by the sharp end of the push rod. The sharp end 1206a of the push rod 1206 can be a solid pointed spike (piercing the tissue and widening the initial opening as it is further pushed into the tissue), or a hypodermic needle (effectively cutting the tissue into a shape approximately the outer diameter of the needle), as shown.

[0131]

[0167] Refer to FIGS. 15A through 15C, which show the shaft device 1500 used with the sleeve device 1200 and its internal components from FIGS. 12A through 14C. The shaft device 1500 can be used in place of the shaft shown as 104 or 104a in the previous figures. FIG. 15A is an external view of the outer shaft 1502 of the shaft device 1500, FIG. 15B is a cross-sectional view of the shaft device, and FIG. 15C is an external view of the inner tube.

[0132]

[0168] The shaft device 1500 can include an outer shaft 1502, which is a flexible elongated tube made of, for example, plastic and / or braided metal and can be configured to be flexibly manipulated inside the endoscope, similar to the shaft 104. The shaft device 1500 can further include an inner tube 1508, which will be further considered below.

[0133]

[0169] The outer shaft 1502 can have a length of, for example, 200 to 3000 mm, and a part of this length, such as 10 to 300 mm, can be disposed inside a handle similar to the handle 102 considered with reference to the previous figures. The outer shaft 1502 can have an outer diameter of, for example, 2 to 10 mm. The outer shaft 1502 can have a uniform or variable diameter along its length.

[0134]

[0170] A distal tube 1504 can be disposed at the distal end of the outer shaft 1502 and fixed to the outer shaft by an adhesive or other fixing means. The distal tube 1502 can be made of a rigid material such as stainless steel or hard plastic. The inner diameter of the distal tube 1504 is slightly larger than the outer diameter of the distal area of the outer shaft 1502, so that the distal tube can surround the distal area of the outer shaft at the location where they are fixed to each other. The distal tube 1504 can have a perforated wall 1504a on the proximal side, such that when an adhesive is used for fixation, the adhesive not only contacts the outer wall of the outer shaft 1052 and the inner wall of the distal tube but also fills the perforations, providing additional resistance to the separation of the distal tube and the outer shaft.

[0135]

[0171] The distal tube 1504 may be intended to surround the grasping means. The grasping means may be configured similarly to the grasping means considered with reference to the previous figures or shown in FIGS. 15E to 15F considered below.

[0136]

[0172] FIG. 15D shows a cross-sectional view of the sleeve device 1200 of FIG. 12A together with the shaft device 1500 of FIGS. 15A to 15C, but the anchor mounted on the push rod 1206 is not shown (for clarity).

[0137]

[0173] The exemplary gripper 1506 shown in FIGS. 15E to 15F is made of the same material as the aforementioned grasping means and may include a tubular base portion 1506a and a plurality of concentric tips 1506b (3 to 8 tips, or 5 tips as shown in the figure) extending distally from this base portion. Since the tips 1506b are biased when disposed and defined within the distal tube 1504 of FIG. 15A, the gripper 1506 can take an overall tubular shape consisting of the tips and the base portion, as shown in FIG. 15E. When the tips 1506b extend distally from the distal tube 1504 and are thereby no longer biased, they are in the enlarged unbiased position shown in FIG. 15F.

[0138]

[0174] The operating mechanism of the gripper 1506 may be similar to some of the aforementioned gripping means. That is, when the gripper 1506 is pushed out of the distal tube 1504, the tip begins to penetrate the tissue in front of the distal tube and mainly advances horizontally inside the tissue while continuing to expand outward. In this way, ideally, the tip does not come out distally from the tissue, remains entirely inside the tissue while expanding, and optionally returns proximally after curling backward to take a hook shape. This helps prevent damage to other tissues (organs, blood vessels, etc.) located on the other side of the tissue. For example, in a surgical procedure performed on the stomach as shown in FIG. 15G (not to scale), the tip 1506b completely penetrates the three inner layers (mucosa, submucosa, and muscular layer) of the stomach wall and may only partially enter (or not enter at all) the outermost layer of the stomach, i.e., the serosa. It is also possible for the tip to not reach the serosa, completely penetrate the mucosa and submucosa, and partially enter the outer muscular layer. Even if one or more of the tips accidentally completely penetrate the tissue (i.e., cross the serosa), this is likely to occur only if these tips are already curled laterally or backward, so the possibility of damaging nearby other tissues (e.g., nearby organs, blood vessels, etc.) is low.

[0139]

[0175] Each of the tips 1506b may have a wall thickness of 0.15 - 0.30 mm (e.g., 0.26 mm), a width of 0.50 - 1.10 mm (e.g., 0.8 mm), and a length from its distal end to the start of the base portion 1506a of 5 - 15 mm (e.g., 7.40 mm). The distal end of each tip 1506b can be rounded and have a triangular shape with a slightly rounded edge (the diameter of the rounded edge is, for example, 0.10 - 0.30 mm). Each of the tips 1506b can gradually expand in width as it approaches the base portion 1506a, strengthening the tip in its transition area. Alternatively, each of the tips can be rectangular along its entire length (not shown). The base portion 1506a and the tip 1506a can have an overall diameter of 2.0 - 3.0 mm (e.g., 2.48 mm) when folded, and the tip can have an overall diameter of 2.50 - 3.50 mm (3.00 mm, etc.) when fully expanded into a hook shape.

[0140]

[0176] The wall thickness of the tip 1506b can be selected such that the distal end is not too sharp, and thus does not damage other tissue located behind the grasped tissue even if one or more of the tips accidentally appear on the other side of the grasped tissue. The configuration of the grasper 1506 (its shape, size, thickness, superelasticity, elasticity, resilience, thermal training, etc.) can be such that a force of 500 to 1500 grams (or more specifically 700 to 1100 grams) is required to pull the grasper backward and fold it into the distal tube 1504. This means that the tip 1506b maintains a hooked shape and is fixed to the tissue throughout the entire anchor implantation procedure because the force for expansion when the grasper 1506 is pulled out of the distal tube 1504 is extremely large (further discussed below).

[0141]

[0177] Further, FIGS. 15B to 15C show an inner tube 1508 fixed to the grasper 1506. The inner tube 1508 is disposed inside the outer shaft 1502 of FIG. 15A. The sleeve device 1200 of FIG. 12A is disposed inside the inner tube 1508. The inner tube 1508 can be made of a flexible material configured to be flexibly manipulated inside the endoscope.

[0142]

[0178] The inner diameter of the base portion 1506a of the grasper 1506 is slightly larger than the outer diameter of the distal area of the inner tube 1508, so that the base portion can surround the distal area of the inner tube at the location where they are fixed to each other. The base portion 1506a can have a perforated wall at least on its proximal side, such that when an adhesive is used for fixation, the adhesive not only contacts the outer wall of the inner tube 1508 and the inner wall of the base portion but also fills the perforations, providing additional resistance to the separation of the grasper 1506 and the inner tube.

[0143]

[0179] To pull the tip 1506b of the grasper 1506 out of the distal tube 1504, the inner tube 1508 can be pushed against the distal tube 1504 from a handle (not shown in this figure).

[0144]

[0180] Here, refer to FIGS. 15H to 15M, which show six alternative configurations of the grasper with different numbers and shapes of tips at the tip. The configurations of FIGS. 15H to 15K are suitable for penetrating the entire layer of tissue, and FIGS. 15L to 15M may be suitable for penetrating only the subserosal layer and optionally also entering a part of the thickness of the serosa. The configuration of FIG. 15L is unique in that it performs a two-stage grasping of the tissue. First, all the tips penetrate the tissue. As the grasper continues to be pushed towards the tissue, the long tips curl backwards, each curling approximately 360 degrees (or more), exiting proximally from the tissue and strengthening the fixation of the tissue.

[0145]

[0181] The outer shaft 1502 and the inner tube 1508 can have complementary structures, which can prevent the tip 1506b from being pulled distally too much and damaging the sleeve device 1200 and / or getting entangled with the sleeve device 1200, especially with the flexible and delicate sleeve 1202. These complementary structures are the step 1502a on the inner wall of the outer shaft 1502 and the opposite step 1508a on the outer wall of the inner tube 1508, which can make it impossible for the outer shaft to be pulled proximally too much. Also, alternative complementary structures are possible (not shown), which are, for example, opposite-shaped steps or any other structure that physically prevents relative movement beyond a specific range of the outer shaft and the inner tube.

[0146]

[0182] By referring to FIGS. 16A to 16D, the overall interaction of the shaft device 1500, the sleeve device 1200, the inner tube 1508, and all the components related thereto can be better understood. These figures show four steps of embedding the anchor 1204 on the opposite side of the tissue 1600.

[0147]

[0183] In FIG. 16A, the entire shaft device 1500, together with all internal components, is adjacent to or in contact with the inner wall of the tissue 1600. The shaft device 1500 can be disposed, for example, inside the working channel of an endoscope (not shown) such as a gastric camera or a colonoscope, and only the distal portion (e.g., the most distal 5 - 30 mm) of the shaft device protrudes beyond the distal end of the endoscope.

[0148]

[0184] In FIG. 16B, by pushing the inner tube 1508 distally, the tip 1506b penetrates the tissue 1600 (ideally not reaching its full thickness) and firmly grips it.

[0149]

[0185] Next, in FIG. 16C, while maintaining the sleeve device 1200 in place, the inner tube 1508 is pulled proximally (along with the outer shaft 1502), and the gripped tissue 1600 is pulled along with it. This simultaneously creates a pocket of sorts within the tissue 1600, penetrates the sharp end of the push rod 1602 through the full thickness of the tissue, and inserts it into that pocket. The most distal anchor 1204 moves with the push rod 1602 and reaches the other side of the tissue 1600.

[0150]

[0186] Next, in FIG. 16D, while preventing the push rod 1602 from retreating through the tissue by stopping the proximal end of the anchor 1204 at the edge of the tissue opening, the push rod 1602 is pulled proximally rearward into the inner tube 1508, passing the anchor. For this reason, the anchor 1204 is released from the push rod 1602 and remains on the distal side of the tissue 1600 inside the pocket. Optionally, the base portion 1506a of the gripper 1506 is configured with a unidirectional ridge (not shown) on its inner surface, which helps to peel the anchor 1204 from the push rod as the push rod 1602 is pulled rearward through the tissue opening. This also helps to prevent the anchor 1204 from remaining on the push rod as the push rod 1602 is pulled rearward.

[0151]

[0187] Next, the gripper 1506 can be released from the tissue 1600 by pulling the gripper rearward into the distal tube 1504, preparing for the next anchor embedding sequence.

[0152]

[0188] As shown in FIGS. 16A through 16D and described above, in the techniques, tissue pockets are created, tissue is pierced, and anchors are implanted on the other side of the tissue. This technique can be facilitated by other embodiments of the device, grasper, and anchor by operating them according to similar principles.

[0153]

[0189] Referring now to FIG. 17A, which is a photograph of a porcine experiment performed using a version of the grasper 1506 having six rather than five tips (such as the grasper 1806 shown in FIGS. 18A through 18B). This photograph shows the tips of the grasper fully expanded and was taken after the grasper was pulled proximally to create a tissue sleeve / pocket, and shows well the tips that are passing through the stomach wall but not completely penetrating the serosa.

[0154]

[0190] Further, referring now to FIG. 17B, which is a photograph taken from another porcine experiment using a five-tip grasper (such as the grasper 1506 in FIGS. 15E through 15F). This photograph shows the sleeve / pocket created by the stomach wall when the grasper is pulled proximally, and further shows that two of the tips of the grasper actually penetrate completely through the stomach wall and appear to project laterally. This demonstrates that even when one or more of the tips accidentally penetrate the full thickness of the tissue, the lateral orientation (and, in some cases, the posterior curling) at that time may prevent damage to the organ on the other side of the penetrated tissue.

[0155]

[0191] Referring now to FIGS. 18A through 18B, perspective and cross-sectional views of a distal area of a shaft device 1800 are shown that may function as an alternative to the shaft 104 / 104a, shaft device 1500, and / or sleeve device 1200 described above. More specifically, the elements of FIGS. 18A through 18B may generally be similar to those shown in FIGS. 12A through 15G and FIGS. 16A through 16D. The main difference is that the embodiments of FIGS. 18A through 18B do not include a flexible sleeve 1202 that houses a series of anchors, and instead may be configured to house a single anchor at a given time. Additionally, the elements of FIGS. 18A through 18B are intended to be similar to the elements of the previous figures when they have the same name, although specific differences will become apparent from the following discussion. The same is true for the functions (ways of operating) of such corresponding elements.

[0156]

[0192] Moving from the inside out, the shaft device 1800 may include some or all of the following. That is, a needle 1808, an anchor 1812 configured to be mounted on the needle, an anchor support 1803 mounted on the needle behind the anchor, an inner tube 1805 mounted on the anchor support, a gripper 1806 attached to, connected to, or integrally formed with the inner tube, an outer shaft 1802 mounted on the inner tube, a distal tube (also referred to as a "gripper collector") 1804 having a proximal area fixedly mounted on the outer shaft and a distal area configured to cover the gripper and the inner tube, and a stopper ring 1804a attached to, connected to, or integrally formed with the inner wall of the gripper collector and adjacent to the distal end of the inner tube (for example, if both the stopper ring and the gripper collector are made of metal, they may be welded together).

[0157]

[0193] Similar to what is shown in FIGS. 16A - 16D, a shaft device 1800 can be used to embed a plurality of anchors on the opposite side of the tissue, and suture threads (not shown in FIGS. 18A - 18B so as not to interfere with the illustration) can interconnect the anchors as described above. During operation, before the various parts of the shaft device are actuated, about 6 - 10 mm in length of the distal area of the shaft device 1800 is exposed beyond the distal end of the endoscope (i.e., beyond the distal opening of the endoscope's working channel). At this stage, these various parts can be covered with the outer shaft 1802 and / or the gripper collector 1803 so as not to damage any tissue.

[0158]

[0194] FIGS. 19A - 19C and FIGS. 20A - 20C show the gripper 1806 in the closed (biased) configuration and the open (expanded) configuration in more detail, respectively. The gripper 1806 can be similar to the gripper 1506 in FIGS. 15E - 15F and can include a tubular base portion 1806a and a plurality of concentric tips 1806b, for example, six tips (optionally any of 3 - 8) as shown in the illustration.

[0159]

[0195] The gripper 1806 can be manufactured from a planar sheet material as shown in FIG. 22, for example by laser cutting. The sheet can be rolled to form the tubular shape of the gripper 1806. For example, an adhesive can be used between the tubular base portion 1806a and the inner tube 1805 to fix the sheet in the tubular shape. By means of an optional series of openings 1806c in the tubular base portion 1806a, a part of the adhesive can be made to enter the openings and dry or cure within the openings, thereby further preventing the gripper 1806 from coming off and rotating freely on the inner tube, and thus reinforcing the interconnection between the tubular base portion and the inner tube 1805. In the examples of FIGS. 19A to 19C and FIGS. 20A to 20C, the gripper 1806 includes 18 such openings 1806c arranged in 6 concentric groups, each group including 3 longitudinally arranged openings. The openings 1806c can occupy an area corresponding to 10 to 70%, more specifically 10 to 30%, 20 to 40%, 30 to 50%, 40 to 60%, or 50 to 70% of the total circumferential area of the tubular base portion 1806a.

[0160]

[0196] The gripper 1806 terminates proximally at the chamfered surface 1806d, preventing or minimizing the collision between the proximal end of the gripper and the distal end of the gripper collector 1804 (or the outer shaft 1802 if there is no gripper collector), thereby facilitating the smooth convergence of the gripper into the gripper collector (or the outer shaft).

[0161]

[0197] The gripper 1806 optionally has the following measurements, which advantageously allow it to fit within the relatively narrow working channel of the endoscope while still being able to achieve good tissue gripping function. That is, the overall length (L T +L B ) can be 10 to 20 mm (or more), for example 10 to 13 mm, 12 to 16 mm, 14 to 17 mm, 16 to 19 mm, or 18 to 20 mm. The length (L B) can be 3 to 8 mm (or more), for example, 3 to 5 mm, 4 to 6 mm, 5 to 7 mm, or 6 to 8 mm. The length (L of the tip 1806b T ) can be 5 to 13 mm (or more), for example, 5 to 7 mm, 7 to 9 mm, 9 to 11 mm, or 10 to 13 mm. The gripper 1806 can have an outer diameter of about 1.5 to 4.5 mm (or more), and the outer diameter is, for example, 1.5 to 2.5 mm, 2 to 3 mm, 2.5 to 3.5 mm, 3 to 4 mm, or 3.5 to 4.5 mm.

[0162]

[0198] The inner tube 1805 can be made of, for example, PEEK, stainless steel, or similar materials.

[0163]

[0199] Referring to FIG. 21A, which is a top view of one distal area of the tip 1806b, each tip can have a width (W) of 0.3 to 1.5 mm (or more) at least at its distal end, and the width (W) is, for example, 0.3 to 0.5 mm, 0.4 to 0.6 mm, 0.5 to 0.7 mm, 0.6 to 0.8 mm, 0.7 to 0.9 mm, 0.8 to 1.0 mm, 0.9 to 1.1 mm, 1.0 to 1.2 mm, 1.1 to 1.3 mm, 1.2 to 1.4 mm, or 1.3 to 1.5 mm. The distal end of the tip can be perpendicular to the longitudinal axis of the gripper 1806, with a rounded tip, that is, having a rounded tip, which slightly promotes tissue penetration while reducing the possibility that the tip completely penetrates to the other side of the tissue. Each radius (R1) of the rounded tip can be 0.05 to 0.75 mm (or more), for example, 0.05 to 0.20 mm, 0.15 to 0.30 mm, 0.25 to 0.40 mm, 0.35 to 0.50 mm, 0.45 to 0.60 mm, 0.55 to 0.70 mm, or 0.65 to 0.75 mm. As seen in FIGS. 19A to 19C, each tip 1806b can have a uniform width along most of its length, for example, along about 80% of the distal length. Alternatively, the tip can gradually narrow towards the distal end and can have an elongated trapezoid shape respectively.

[0164]

[0200] Referring to FIG. 21B, which is a side view of one of the same distal areas of tip 1806b, each tip can have a thickness (D) of 0.1 to 0.85 mm (or more), at least at its distal end. The thickness (D) can be, for example, 0.10 to 0.25 mm, 0.20 to 0.35 mm, 0.30 to 0.45 mm, 0.40 to 0.55 mm, 0.50 to 0.65 mm, 0.60 to 0.75 mm, or 0.70 to 0.85 mm. Also, as shown in FIG. 22, this can also be the thickness of the sheet material from which the gripper 1806 is made.

[0165]

[0201] Tip 1806a (or its related part) can be trained (e.g., using heat treatment known in the art) to take the shape shown in FIGS. 20A to 20C when not biased by the gripper collector 1804 (or the outer tube if no gripper collector is used). Referring to FIG. 21C, which is a side (lateral) view of one of the tips 1806b in the expanded (non-biased) state, each tip can curve backward at an angle of about 180 degrees as shown, or more generally, at 145 to 205 degrees, such as 145 to 160 degrees, 155 to 170 degrees, 165 to 180 degrees, 175 to 190 degrees, 185 to 200 degrees, or 195 to 205 degrees. The inner radius of curvature (R2) of the curved area of the tip can be 1 to 5 mm (or more), for example, 1.0 to 2.0 mm, 1.5 to 2.5 mm, 2.0 to 3.0 mm, 2.5 to 3.5 mm, 3.0 to 4.0 mm, 3.5 to 4.5 mm, or 4.0 to 5.0 mm. Optionally, the tip can have a straight (non-curved) most distal area (A) distal to the curved area. The length of this area can be about 0.5 to 5.0 mm (or more), for example, 0.5 to 2.0 mm, 1.5 to 3.0 mm, 2.5 to 4.0 mm, or 3.5 to 5.0 mm.

[0166]

[0202] Returning to FIGS. 19A through 19C and FIGS. 20A through 20C, the chamfered surface 1806d can have an angle of 10 to 45 degrees (or more) with respect to the longitudinal axis of the gripper 1806, and this angle can be, for example, 10 to 25 degrees, 20 to 35 degrees, or 30 to 45 degrees. The chamfered surface 1806d can occupy a length of 0.3 to 1.4 mm (or more) of the length (L B ) of the tubular base portion 1806a, and this length can be, for example, 0.3 to 0.6 mm, 0.5 to 0.8 mm, 0.7 to 1.0 mm, 0.9 to 1.2 mm, or 1.1 to 1.4 mm.

[0167]

[0203] The gripper 1806 can be configured to apply a gripping force of about 0.5 to 2.0 kilograms (kg) to tissue when expanded (not energized). This force can be, for example, 0.5 to 0.8 kg, 0.7 to 1.0 kg, 0.9 to 1.2 kg, 1.1 to 1.4 kg, 1.3 to 1.6 kg, 1.5 to 1.8 kg, or 1.7 to 2.0 kg. This gripping force function can be the result of the material from which the tip 1806a is made, their training, and their measured values.

[0168]

[0204] Now, refer to FIG. 23A, which shows a side view of the distal area of the needle 1808. Generally, the needle 1808 can be solid (not hollow) and can be made of a superelastic material such as nitinol, or an elastic material such as stainless steel or CoCr. The needle 1808 can have a length similar to that of the outer shaft 1802 and can extend to the handle. The needle 1808 can have a diameter of 0.4 to 1.5 mm (or more), except for certain grooves that will be further considered below, and this diameter can be, for example, 0.4 to 0.7 mm, 0.5 to 0.8 mm, 0.6 to 0.9 mm, 0.7 to 1.0 mm, 0.8 to 1.1 mm, 0.9 to 1.2 mm, 1.0 to 1.3 mm, 1.1 to 1.4 mm, or 1.2 to 1.5 mm.

[0169]

[0205] The needle 1808 can have a sharp end, such as a multi-faceted tip. FIG. 23B shows such a sharp end, viewed from the front, with three exemplary facets 1808c. Each facet 1808c can have an angle (α) of 8 to 30 degrees (or more) with respect to the longitudinal axis of the needle 1808, and this angle can be, for example, 8 to 12 degrees, 10 to 14 degrees, 12 to 16 degrees, 14 to 18 degrees, 16 to 20 degrees, 18 to 22 degrees, 20 to 24 degrees, 22 to 26 degrees, 24 to 28 degrees, or 26 to 30 degrees.

[0170]

[0206] As shown in more detail in FIG. 23C, the needle 1808 can include a groove 1808a in its distal area. The groove 1808a is configured to receive the inward tabs of the anchor, as will be discussed in more detail below, so that the anchor can be maintained in a fixed state on the needle 1808 as the needle penetrates the tissue. The groove 1808a can have a length (L2) of 1 to 3 mm (or more), and this length can be, for example, 1 to 2 mm, 1.5 to 2.5 mm, or 2 to 3 mm. The groove 1808a can have a diameter of about 50 to 80% of the diameter of the needle 1808 in its thinnest area, as described above. The groove 1808a can include an inclined surface 1808b that is disposed at an angle of 15 to 45 degrees (or more) with respect to the longitudinal axis of the needle on the distal side. This angle can be, for example, 15 to 25 degrees, 20 to 30 degrees, 25 to 35 degrees, 30 to 40 degrees, or 35 to 45 degrees. Optionally, a concave surface (R1) exists between the inclined surface 1808b and the thinnest area of the groove 1808a to allow the leading edge of the inward tab of the anchor to slide more easily outside the groove. The concave surface (R1) can have a radius of curvature of, for example, 0.02 to 0.10 mm. The groove 1808a can include another concave surface (R2) having a radius of curvature of, for example, 0.02 to 0.30 mm on the proximal side. Generally speaking, the diameter of the groove 1808a can gradually decrease from the maximum diameter of the needle 1808 to the thinnest area of the groove.

[0171]

[0207] The tip area of the needle 1808 from the distal end of the needle to the starting point of the groove 1808a can have a length (L1) of 1 to 10 mm (or more), and this length can be, for example, 1 to 3 mm, 2 to 4 mm, 3 to 5 mm, 4 to 6 mm, 5 to 7 mm, 6 to 8 mm, 7 to 9 mm, or 8 to 10 mm.

[0172]

[0208] Here, refer to FIGS. 25A to 25D showing the anchor 1812 in the closed (biased) configuration in four vertical side views. Also refer to FIGS. 26A to 26C showing the anchor 1812 in the open (expanded, unbiased) configuration in a first perspective view, a side view, and a second perspective view.

[0173]

[0209] The anchor 1812 can optionally have a generally tubular body that is cut (e.g., laser cut) from a material tube or cut (e.g., laser cut) from a sheet material and rounded. This material can be superelastic such as nitinol, or elastic (and optionally resilient) such as stainless steel, CoCr, PEEK, etc. The tubular body can have a wall thickness of about 0.1 to 0.4 mm (or more), and this wall thickness can be, for example, 0.1 to 0.2 mm, 0.15 to 0.25 mm, 0.2 to 0.3 mm, 0.25 to 0.35 mm, or 0.3 to 0.4 mm. The tubular body can have a length of about 4 to 16 mm (or more), and this length can be, for example, 4 to 7 mm, 6 to 9 mm, 8 to 11 mm, 10 to 13 mm, or 12 to 16 mm. The tubular body can have an outer diameter of about 0.5 to 2 mm (or more), and this outer diameter can be, for example, 0.5 to 0.8 mm, 0.7 to 1.0 mm, 0.9 to 1.2 mm, 1.1 to 1.4 mm, 1.3 to 1.6 mm, 1.5 to 1.8 mm, or 1.7 to 2.0 mm.

[0174]

[0210] The anchor 1812 may basically include an extension portion 1812a which is a shaped cutout from the side wall. The extension portion 1812a can be trained (e.g., using appropriate heat treatment in the case of Nitinol) to rise at an angle of about 45 to 135 degrees (or more) with respect to the longitudinal axis of the anchor. This angle can be, for example, 45 to 60 degrees, 55 to 70 degrees, 65 to 80 degrees, 75 to 90 degrees, 85 to 100 degrees, 95 to 110 degrees, 105 to 120 degrees, 115 to 130 degrees, or 125 to 135 degrees. Optionally, when the extension portion 1812a is expanded, the anchor 1812 basically has a T-shape. The extension portion 1812a can have a length of 2 to 8 mm (or more), and this length can be, for example, 2 to 3 mm, 3 to 4 mm, 4 to 5 mm, 5 to 6 mm, 6 to 7 mm, or 7 to 8 mm. The extension portion 1812a can have a width of 0.5 to 2 mm (or more), and this width can be, for example, 0.5 to 0.8 mm, 0.7 to 1.0 mm, 0.9 to 1.2 mm, 1.1 to 1.4 mm, 1.3 to 1.6 mm, or 1.5 to 1.8 mm, or 1.7 to 2.0 mm. When the extension portion 1812a is inside the inner tube 1805 (of FIG. 18B), the anchor 1812 can be biased to approximately the same tubular circumference as the entire anchor. The ratio of the length of the tubular body of the anchor 1812 to the extension portion 1812a is, for example, 1:0.3 to 1:0.7, and more specifically, 1:0.3 to 1:05, 1:0.4 to 1:0.6, or 1:0.5 to 1:0.7.

[0175]

[0211] Similar to the aforementioned anchor, the extension portion 1812a may include an opening (also referred to as a "loop" or "ring") 1812b that allows the passage of a suture (not shown here). The inner edge of the opening 1812b can be processed to be extremely smooth (e.g., up to a surface roughness of 10 or 20 microns maximum) by, for example, electropolishing to prevent damage to the suture when tension is applied. Additionally or alternatively, the inner edge may be coated with a smooth material, optionally a polymer.

[0176]

[0212] Further, the anchor 1812 may also include an inward tab 1812e cut out from the side wall. The inward tab 1812e is trained (e.g., using appropriate heat treatment) to project into the space of the tubular body of the anchor by about 0.1 to 1.3 mm. The inward tab 1812e may be disposed on the side opposite to the expansion portion 1812a.

[0177]

[0213] An alternative anchor (not shown) is similar to the anchor 1812 but may not include an expansion portion. Instead, the suture can be passed through a pair of openings around the central portion of the side wall of the anchor or through any other suitable structure that does not protrude significantly from the side wall of the anchor.

[0178]

[0214] Referring back to FIG. 18B, it can be seen that the inward tab fits into the groove of the needle 1808 and the anchor 1812 cannot slide distally off the needle unless sufficient force is applied. Sufficient force is, for example, 0.1 to 1 kg (or more), more specifically 0.1 to 0.3 kg, 0.2 to 0.4 kg, 0.3 to 0.5 kg, 0.4 to 0.6 kg, 0.5 to 0.7 kg, 0.6 to 0.8 kg, 0.7 to 0.9 kg, or 0.8 to 1.0 kg. This force can be applied by keeping the anchor support portion 1803 stationary and pulling the needle 1808 proximally to slide the anchor 1812 distally away from the needle on the needle.

[0179]

[0215] Returning to FIGS. 25A to 25D and FIGS. 26A to 26C, the anchor 1812 is optionally inclined (1812c) and / or chamfered (1812d) at the distal end to minimize the resistance from the tissue when the needle 1808 pierces the tissue and the pierced hole is enlarged by the passage of the anchor. The inclination 1812c and / or the chamfer 1812d can each be at an angle of 10 to 50 degrees with respect to the longitudinal axis of the anchor 1812, and this angle is, for example, 10 to 20 degrees, 15 degrees to 25 degrees, 20 to 30 degrees, 25 to 35 degrees, 30 to 40 degrees, 35 to 45 degrees, or 40 to 50 degrees.

[0180]

[0216] Referring to FIG. 27, the alternative anchor 1813 can be identical to the anchor 1812, except that the distal end may not include an inclination.

[0181]

[0217] Referring again to FIGS. 18A to 18B, the anchor 1812 can be supported from behind by an anchor support portion 1803, which is a tube that optionally extends to the handle. The anchor support portion 1803 can be made of one of the elastic or superelastic materials described above, or a similar material. The outer diameter of the anchor support portion 1803 can be made larger than the inner diameter of the anchor 1812 to prevent the anchor from sliding backward when the anchor support portion is held stationary. Thus, when the needle 1808 is pulled proximally, the anchor 1812 is forced to slide forward on the needle and is ultimately released from the needle.

[0182]

[0218] Referring again to FIGS. 18A to 18B, the gripper collector 1804 is a tube made of stainless steel, Co-Cr, etc., and can be fixedly mounted on the outer shaft 1802, for example, by using an adhesive or by melting a polymer (e.g., PEEK) outer shaft on the gripper collector. The gripper collector 1804 has a series of optional openings 1804b in the proximal 1 to 10 mm (or more), and by allowing a part of the adhesive to enter these openings and dry or cure within the openings, the mutual connection between the gripper collector and the outer shaft 1802 can be strengthened. Thereby, it can further prevent the gripper collector from coming off and freely rotating on the outer shaft.

[0183]

[0219] The gripper collector 1804 may further include one or more elongated slits 1804c. The elongated slits 1804c are arranged at an angle of 30 to 80 degrees with respect to the longitudinal axis of the gripper collector and are positioned inside the middle third of its length, giving the gripper collector a certain degree of axial flexibility. That is, when the gripper collector is inside the working channel of the endoscope and the endoscope is bent like a joint at an acute angle, the flexibility of the gripper collector can prevent the gripper collector from becoming immobile inside the working channel.

[0184]

[0220] The gripper collector 1804 may further include the stopper ring 1804a briefly described above. The stopper ring 1804a can be made of one of the materials described above with respect to the gripper collector 1804 and can be configured to prevent the gripper from accidentally sliding into the outer tube 1802 when the gripper 1806 is pulled backward. This can occur when the outer tube is made of polymer (e.g., made of PEEK) and the inner diameter of the polymer outer tube is forcibly expanded by the high rigidity of the gripper moving backward, and the gripper fits into it. The stopper ring 1804a is at least as rigid as the gripper 1806 and can prevent this from occurring.

[0185]

[0221] Regarding the outer shaft 1802, its purpose may be to house the further inner part of the shaft device 1800. The outer shaft 1802 may have an outer shape that can fit into the working channel of the endoscope. For example, the outer diameter is at most 3 mm (or a larger outer diameter in other embodiments). The outer shaft 1802 can be made of materials such as stainless steel or PEEK. To increase the flexibility and ability to bend like a joint in a flexible endoscope, the outer shaft can alternatively be configured as a coil or a mesh.

[0186]

[0222] An apparatus for implanting an anchor into the opposite side of tissue for suturing the tissue (an apparatus including the shaft device 1800 of FIGS. 18A to 18B) may operate generally as follows (similar to that described above with reference to FIGS. 16A to 16D, but with some differences that will become apparent from the following discussion).

[0187]

[0223] Position the distal area of the shaft device 1800, along with all internal components, adjacent to or in contact with the inner wall of the tissue. The shaft device 1800 can be disposed, for example, inside the working channel of an endoscope (not shown) such as a gastric camera or a colonoscope, and only the distal portion of the shaft device (e.g., the most distal 5 - 30 mm) extends beyond the distal end of the working channel.

[0188]

[0224] Push the inner tube 1805 distally and move it together with the attached gripper 1806, so that the tip 1806b penetrates the tissue while curling backward and firmly grips the tissue. As described above, this penetration can reach a partial layer or the entire layer of the tissue.

[0189]

[0225] Next, while maintaining the needle 1808, the anchor 1812, and the anchor support 1803 stationary in place, pull the inner tube 1805 and the gripper 1806 proximally (together with the outer shaft 1802 and the gripper collector 1804), thereby pulling the tissue held therewith. This creates the aforementioned pocket in the tissue, and at the same time, the sharp end of the needle 1808 and then the anchor 1812 penetrate the entire layer of the tissue, and the anchor completely enters the pocket.

[0190]

[0226] Next, while maintaining the anchor support 1803 stationary in place, pull the needle 1808 proximally into the inner tube 1805 rearward, so that the anchor 1812 slides on the needle. Thereby, the anchor 1812 is released and remains on the distal side of the tissue inside the pocket.

[0191]

[0227] Next, the grasper 1806 is released from the tissue by pulling it rearward into the grasper collector 1804 (or directly into the outer shaft 1802 if no grasper collector is used), or by advancing the grasper collector 1804 (or outer shaft 1802) forward over the grasper, such that the tip 1812b assumes a straight configuration in which it is biased.

[0192]

[0228] Next, another anchor is loaded at a designated position over the groove of the needle 1808 within the shaft assembly 1800, and the above procedure is repeated.

[0193]

[0229] After all the anchors have been implanted, a suture (not shown) can be tensioned to draw all the anchors (and the tissue they secure) closer together, and the suture can be secured to the last (most proximal) anchor. This securing can be done, for example, by manually creating a knot of sufficient size on the anchor to prevent the suture from passing through the loop of the last anchor, or by using a fastener.

[0194]

[0230] The method of operating the device can be better understood with reference to FIG. 24. FIG. 24 is a flowchart of a method 2400 for suturing tissue, including the following steps.

[0195]

[0231] Step 2402 can include inserting a flexible endoscope into a body opening of a patient (such as the mouth, nose, rectum, or vagina). The flexible endoscope includes a working channel having a distal opening.

[0196]

[0232] Step 2404 can include providing a tubular grasper including an elastic tip configured to expand outwardly when not biased.

[0197]

[0233] Step 2406 can include exposing the tubular grasper from the distal opening of the working channel and releasing the bias of the tip so as to penetrate and secure tissue as the tip expands outwardly.

[0198]

[0234] Step 2408 may include providing a needle disposed inside the tubular grasper and a tubular anchor disposed on and fixed to the needle. A surgical thread is passed through the tubular anchor.

[0199]

[0235] Step 2410 may include pulling the tubular grasper proximally so that the fixed tissue forms a sleeve, the tissue is pierced by the needle, and the tubular anchor reaches the distal side of the tissue while being fixed to the needle.

[0200]

[0236] Step 2412 may include pulling the needle proximally and releasing the tubular anchor from the flexible needle on the distal side of the tissue within the formed sleeve.

[0201]

[0237] Step 2414 may include biasing the tip so that the tissue is released from the tip of the tubular grasper.

[0202]

[0238] Step 2416 may include loading a new tubular anchor onto the flexible needle and repeating steps 2406, 2410, 2412, and 2414 for the new tubular anchor.

[0203]

[0239] Step 2418 may include applying tension to the surgical thread to form a suture extending between the tubular anchor and the new tubular anchor.

[0204]

[0240] Step 2420 may include fixing the surgical thread to the new tubular anchor so that the tension is maintained.

[0205]

[0241] An important aspect of an embodiment of the present invention is the layered, substantially concentric configuration of the elements of the shaft device described above. Each element is generally tubular in shape and is mounted over, behind, or in front of one or more of the other elements. This enables suturing of tissue (by implanting a series of anchors interconnected by suture threads) through the working channel of the endoscope, allowing only movement along the longitudinal axis of the working channel. This axial movement of the elements (relative to each other and relative to the working channel) eliminates the need for various "on-tube" type tools that would otherwise have to be mounted on the distal area of the endoscope. Also, this eliminates the need to implement several small, complex, and delicate tools for suturing tissue from side to side, i.e., passing the suture thread in a direction substantially perpendicular to the working channel of the endoscope.

[0206]

[0242] Another important aspect of an embodiment of the present invention is the expansion portion of the anchor. The expansion portion can be biased to conform to the generally tubular shape of the anchor once it is placed inside the associated shaft device and rises to an expanded configuration once the anchor is released. When the expansion portion expands, for example, into a configuration perpendicular to the longitudinal axis of the tubular body of the anchor, this prevents the anchor from returning to the proximal side of the tissue through the opening already created by the needle. That is, a T-shaped structure (the anchor including the expanded expansion portion) is highly unlikely to pass through an opening having a diameter similar to that of one of the arms of the T. Optionally, when tension is applied to the suture thread, only the end region of the expansion portion where the loop is located returns through the opening in the tissue.

[0207]

[0243] Yet another important aspect of embodiments of the present invention is that the grasper (FIGS. 15E-15G, FIGS. 18A-18B, or other grasper), particularly when its tip is grasping tissue, enters the tissue only partially (without reaching its full layer) or, in rare cases, only after the tip has expanded at an angle greater than about 60°, 70°, 80°, 90°, 100°, 110°, or 120° with respect to the longitudinal axis of the tubular base portion of the grasper and penetrates to the distal side of the tissue such that the distal edge of the time is configured to have a low likelihood of damaging the distal organ accidentally adjacent to the penetrated tissue.

[0208]

[0244] The needle can be hollow in some embodiments and solid in other embodiments, regardless of the type of needle described above with respect to specific embodiments by way of example. Merely by way of example, the needle 1808 in FIGS. 18A-18B is illustrated and considered as a solid needle, but can also be configured as a hollow needle.

[0209]

[0245] In some embodiments, a biocompatible lubricant can be introduced between the surfaces of substantially concentric elements to facilitate their mutual sliding. For example, a lubricant can be provided between the outer shaft and the inner shaft (on which the grasper is mounted), between the inner shaft and the anchor support, between the anchor support and the needle, etc. To introduce the lubricant between such parts, during the manufacture of the device and / or during the use of the device, the lubricant can be injected into the appropriate opening of the handle to disperse the lubricant into the various lumens. Instead of or in addition to the lubricant, during the use of the device, a biocompatible cleaning fluid can be injected distally through one or more of the lumens to push out and discharge dirt such as blood and tissue particles that may have entered the distal area of the shaft device.

[0210]

[0246] In some embodiments, the inner diameter of each tubular element (or an element having a tubular portion) can be 0.1 mm to 1.0 mm (e.g., 0.1 - 0.3 mm, 0.2 - 0.4 mm, 0.3 - 0.5 mm, 0.4 - 0.6 mm, 0.5 - 0.7 mm, 0.6 - 0.8 mm, 0.7 - 0.9 mm, or 0.8 - 1.0 mm) larger than the outer diameter of the tubular element (or an element having a tubular portion) disposed inside it. This space between the stacked (optionally, substantially concentric) elements facilitates their relative movement (sliding relative to each other), but is small enough that the outermost element, such as the outer shaft (and / or the gripper collector) described above, has an outer diameter small enough to fit within the working channel of the endoscope.

[0211]

[0247] The handle in an embodiment of the present invention may include a plurality of actuators physically connected to at least some of the elements of the shaft device. These actuators enable a user (such as a surgeon) to operate these elements from the handle in order to perform various steps of suturing tissue as described above. Alternatively, such actuators may be provided without a handle.

[0212]

[0248] When using some embodiments of the present invention inside a patient's stomach (from an endoscopic esophageal approach), the tissue (stomach wall) sleeve formed by pulling the gripper backward may not be conical (or not substantially conical) and may be substantially cylindrical. This is because the abdominal cavity is typically in a vacuum state during surgery. Also, by operating a vacuum pump via the endoscope to reduce the stomach on the distal area of the endoscope (or on any part of the shaft device extending from the distal end of the endoscope), it is possible to more favorably facilitate the operation of the shaft device for suturing tissue, particularly the grasping of tissue using the gripper.

[0213]

[0249] The descriptions of the various embodiments of the present invention are presented for purposes of illustration, but are not intended to be exhaustive or to limit the invention to the disclosed embodiments. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen to best explain the principles of the embodiments, the practical application, or technical improvements in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

[0214]

[0250] In the description and claims, the terms "substantially," "essentially," and each of their forms, when describing a numerical value, mean a deviation of up to 20% (i.e., ±20%) from that value. Similarly, when such terms describe a numerical range, this means a range that is up to 20% wider (10% on each side of the range). Further, when using the terms "substantially," "essentially," and each of their forms to describe geometric terms that define an angle ("perpendicular," "orthogonal," "parallel," "planar," "coplanar," "coaxial," "horizontal," "vertical," etc.), this means a deviation of up to 25 degrees (i.e., ±25°) from that angle.

[0215]

[0251] The recitation of a numerical range should be considered to specifically disclose all possible sub-ranges and individual numerical values within that range. For example, the recitation of a range of 1 to 6 should be considered to specifically disclose sub-ranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., and individual numbers within that range such as 1, 2, 3, 4, 5, and 6. This is true regardless of the breadth of the range. Similarly, the recitation of a range of fractions from 0.6 to 1.1 should be considered to specifically disclose sub-ranges such as 0.6 to 0.9, 0.7 to 1.1, 0.9 to 1, 0.8 to 0.9, 0.6 to 1.1, 1 to 1.1, etc., and individual numbers within that range such as 0.6, 0.7, 0.8, 0.9, 1, and 1.1.

[0216]

[0252] In the description and claims of this application, the words "comprise", "include", and "have", and each of their forms, are not necessarily limited to the elements in a list to which these words can be associated. Further, in the event of a conflict between this application and any document incorporated herein by reference, this application is intended to control.

Claims

1. A tubular grasper including an elastic tip configured to expand outward when not biased, a needle disposed inside the tubular grasper and configured to penetrate tissue, a tubular anchor disposed on the needle, and a surgical thread passed through the tubular anchor. An apparatus comprising the above.

2. The tubular grasper is pushed distally from the distal end of an endoscope such that the tip expands outward, penetrates the tissue, and secures the tissue to the grasper, the tubular grasper is pulled proximally such that the tissue secured to the grasper is pulled proximally while the needle and the tubular anchor penetrate the tissue to position the anchor on the distal side of the tissue, the flexible needle is pulled proximally to release the tubular anchor on the opposite side of the tissue, and the tubular anchor pulls the tissue proximally by applying tension to the surgical thread on the proximal side of the tissue. The apparatus according to claim 1, further comprising one or more actuators configured as above.

3. The apparatus according to claim 2, wherein the one or more actuators are at least partially included within a handle.

4. The tubular anchor includes a tubular body and an elastic expansion portion configured to expand outward from the tubular body when not biased, and the expansion portion includes a ring through which the surgical thread is passed. The apparatus according to any one of claims 1 to 3.

5. An inner shaft to which the tubular grasper is fixed, and a flexible tubular outer shaft configured to accommodate the inner shaft. The apparatus according to any one of claims 1, 2, and 4, further comprising the above.

6. The apparatus according to claim 5, wherein the one or more actuators are at least partially included within a handle, and the inner shaft extends to the handle.

7. The apparatus according to any one of claims 1 to 6, further comprising a tubular grasper collector mounted on the outer shaft and configured to accommodate the tubular grasper.

8. The apparatus according to any one of claims 1 to 7, wherein each of the tips of the tubular grasper has a rounded edge.

9. The apparatus according to any one of claims 1 to 8, wherein the expansion portion is cut from the wall of the tubular anchor.

10. The device according to any one of claims 4 to 9, wherein the ratio of the length of the tubular body of the anchor to the extension portion of the anchor is from 1:0.3 to 1:0.

7.

11. The device according to any one of claims 1 to 10, wherein the tubular body of the anchor has a chamfered distal edge to facilitate penetration of the tissue together with the needle.

12. The device according to any one of claims 1 to 11, wherein the tubular body of the anchor has an inclined distal edge to facilitate penetration of the tissue together with the needle.

13. A tubular body made of an elastic material and having a plurality of tips configured to expand outward when not biased, A tube configured to house the tubular body and the tips and to bias the tips so that the tips take a tubular configuration, An actuator, An actuator configured to push the tubular body against the tube so that the tips penetrate the tissue and fix the tissue to the tips as the tips expand outward from the tube, An actuator configured to pull the tubular body against the tube so that the tips enter the tube while releasing the tissue, and an actuator configured as such, comprising a tissue grasper.

14. The tissue grasper according to claim 13, wherein the elastic material is a superelastic metal alloy and the tips are trained to a normal expanded configuration.

15. The tissue grasper according to any one of claims 13 to 14, wherein the plurality of tips are from 3 to 8 tips.

16. The tissue grasper according to any one of claims 13 to 14, wherein the plurality of tips are from 4 to 7 tips.

17. The tissue grasper according to any one of claims 13 to 14, wherein the plurality of tips are from 5 to 6 tips.

18. The tissue grasper according to any one of claims 13 to 17, wherein each of the tips has a rounded edge.

19. a) Inserting a flexible endoscope including a working channel having a distal opening into a body opening of a patient; b) Providing a tubular grasper including an elastic tip configured to expand outward when not biased; c) Exposing the tubular grasper from the distal opening of the working channel and releasing the bias of the tip so that the tip penetrates and fixes the tissue when the tip expands outward. d) providing a needle disposed inside the tubular grasper and a tubular anchor disposed on and fixed to the needle, the tubular anchor through which a surgical thread is passed; e) pulling the tubular grasper proximally so that the fixed tissue forms a sleeve, the tissue is pierced by the needle, and the tubular anchor reaches the distal side of the tissue while being fixed to the needle; f) pulling the needle proximally and releasing the tubular anchor from the flexible needle on the distal side of the tissue within the formed sleeve; g) biasing the tip so that the tissue is released from the tip of the tubular grasper; h) loading a new tubular anchor onto the flexible needle and repeating steps c, e, f, and g for the new tubular anchor; i) applying tension to the surgical thread to form a suture extending between the tubular anchor and the new tubular anchor; j) fixing the surgical thread to the new tubular anchor so that the tension is maintained; A method comprising.

20. The method according to claim 19, further comprising providing one or more actuators configured to facilitate steps c, e, f, and g.

21. The method according to claim 20, wherein the one or more actuators are at least partially included within a handle.

22. The tubular anchor includes a tubular body and an elastic expansion portion configured to expand outward from the tubular body when not biased, and the expansion portion includes a ring through which the surgical thread is passed. The method according to any one of claims 19 to 21.

23. providing an inner shaft to which the tubular grasper is fixed; providing a flexible tubular outer shaft configured to accommodate the inner shaft; The method according to any one of claims 19, 20, and 22, further comprising.

24. The method according to claim 23, wherein the one or more actuators are at least partially included within a handle and the inner shaft extends to the handle.

25. The method according to any one of claims 19 to 24, further comprising providing a tubular grasper collector mounted on the outer shaft and configured to accommodate the tubular grasper. Claim 26 The method according to any one of claims 19 to 25, wherein each of the tips of the tubular gripper has a rounded leading edge. Claim 27 The method according to any one of claims 19 to 26, wherein the expansion portion is cut from the wall of the tubular anchor. Claim 28 The method according to any one of claims 22 to 27, wherein the ratio of the length of the tubular body of the anchor to the expansion portion of the anchor is from 1:0.3 to 1:0.

7. Claim 29 The method according to any one of claims 22 to 28, wherein the tubular body of the anchor has a chamfered distal edge to facilitate penetration of the tissue together with the needle. Claim 30 The method according to any one of claims 22 or 29, wherein the tubular body of the anchor has an inclined distal edge to facilitate penetration of the tissue together with the needle.

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