Minimally invasive endoscope suturing device

Abstract

An apparatus, comprising: a tubular gripper comprising a resilient prong configured to expand outward when unbiased; a needle disposed inside the tubular gripper and configured to penetrate tissue; a tubular anchor disposed on the needle; and a surgical wire passing through the tubular anchor.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 390,367, filed on July 19, 2022, entitled “Minimally-Invasive Endoscopic Suturing Device,” the contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to the field of endoscopic surgical instruments. Background Art

[0004] Suturing remains a common method of repairing living tissue and is used for tissue closure, approximation, ligation and fixation of tissue access sites, organs, vessels (blood vessels), fixation of meshes and other implants or devices, etc. Although largely dependent on the skill of the surgeon or endoscopist, the results obtained using sutures are highly predictable and reliable.

[0005] Suture alternatives, such as clamps, staples, fasteners (also known as "tacks"), anchors, and tissue adhesives, have been developed over the years and have gained varying degrees of acceptance and use for tissue repair in open and minimally invasive procedures such as laparoscopic and flexible gastrointestinal (GI) endoscopic procedures.

[0006] Nevertheless, manual suturing remains the mainstream of surgical repair, but it is not without disadvantages. Manually suturing a large number of stitches can be very tiring and time-consuming, which can lead to suturing errors and compromise the integrity of the repair. In fact, for many procedures, the time spent on suturing can be longer than the time spent on treating the underlying target tissue. In endoscopic procedures, manual suturing is almost impossible, and the various suturing aids available on the market are often cumbersome and difficult to use. Even robotic surgical platforms, although capable of very accurate and delicate suturing, are generally limited by the speed at which the remotely operated surgeon can manipulate the robotic platform handles.

[0007] The foregoing examples of the related art and their related limitations are intended to be illustrative and not exclusive. Other limitations will be apparent to those skilled in the art by reading the specification and studying the drawings. Summary of the invention

[0008] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools, and methods, which are intended to be exemplary and illustrative, not limiting in scope.

[0009] Some embodiments relate to a device for suturing tissue, comprising: a flexible, slender shaft configured to be inserted into a working channel of an endoscope; a handle disposed at the proximal end of the slender shaft; a plurality of anchors disposed in a single row within the slender shaft, wherein each of the plurality of anchors comprises: an elongated body, and an extension extending outward from the elongated body; a wire disposed along the length of the elongated shaft and sequentially passing through the extension of the anchor; a grasping mechanism that can be triggered by the handle and is configured to secure tissue to the device during anchor deployment; and an anchor deployment mechanism that can be triggered by the handle and is configured to penetrate tissue with the elongated shaft or with a needle disposed within the elongated shaft, and deploy the anchors one by one from the elongated shaft or the needle into a space beyond the tissue, so that when the wire is tensioned, the longitudinal dimension of each deployed anchor is flush with the surface of the tissue.

[0010] In some embodiments, the grasping mechanism comprises a plurality of sharp elements configured to axially penetrate tissue, or a helical portion configured to screw into tissue.

[0011] Some embodiments relate to a device for suturing tissue 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 tightly secure a suture passing through the anchors and primarily on the first side of the tissue.

[0012] Some embodiments relate to methods of minimally invasive full-thickness suturing.

[0013] Some embodiments relate to methods of minimally invasive gastrointestinal surgery.

[0014] In some embodiments, a device is provided, comprising: a tubular grasper comprising resilient tines configured to expand outward when unbiased; a needle disposed within the tubular grasper and configured to penetrate tissue; a tubular anchor disposed on the needle; and a surgical thread passed through the tubular anchor.

[0015] In some embodiments, a method is provided, comprising: (a) inserting a flexible endoscope through a body orifice of a patient, the flexible endoscope comprising a working channel having a distal opening; (b) providing a tubular grasper, the tubular grasper comprising resilient tines configured to expand outwardly when unbiased; (c) exposing the tubular grasper from the distal opening of the working channel and unbiasing the tines so that the tines penetrate and secure tissue when they expand outwardly; (d) providing a needle disposed within the tubular grasper, and a tubular anchor disposed on and secured to the needle, wherein a surgical thread is passed through the tubular anchor; and (e) pulling the tubular grasper proximally. (f) withdrawing the needle proximally and releasing the tubular anchor from the flexible needle at the distal side of the tissue within the formed sleeve; (g) biasing the tines of the tubular grasper so that the tissue is released from the tines; (h) loading a new tubular anchor onto the flexible needle and repeating steps c, e, f and g with respect to the new tubular anchor; (i) tensioning the surgical thread to form a suture extending between the tubular anchor and the new tubular anchor; and (j) securing the surgical thread relative to the new tubular anchor so that the tension is maintained.

[0016] In some embodiments, the device also includes one or more actuators configured to: push the tubular grasper distally outside the distal end of the endoscope so that the tines expand outward, pierce the tissue, and secure the tissue to the grasper; pull the tubular grasper proximally so that the tissue secured to the grasper is pulled proximally while the needle and tubular anchor penetrate the tissue, thereby positioning the anchor distal to the tissue; pull the flexible needle proximally and release the tubular anchor beyond the tissue; and tension the surgical thread proximal to the tissue, thereby causing the tubular anchor to pull the tissue proximally.

[0017] In some embodiments, the one or more actuators are at least partially contained within the handle.

[0018] In some embodiments, a tubular anchor comprises a tubular body and a resilient extension configured to expand outwardly from the tubular body when unbiased, and wherein the extension comprises a loop through which a surgical thread is passed.

[0019] In some embodiments, the apparatus further comprises: an inner shaft having the tubular grasper secured thereto; and a flexible tubular outer shaft configured to surround the inner shaft.

[0020] In some embodiments, the one or more actuators are at least partially contained within a handle, and wherein the inner shaft extends to the handle.

[0021] In some embodiments, the apparatus further comprises: a tubular grabber collector mounted on the outer shaft and configured to surround the tubular grabber.

[0022] In some embodiments, each tine of the tubular grabber has a blunt edge.

[0023] In some embodiments, the extension is a cut through the wall of the tubular anchor.

[0024] In some embodiments, the length ratio between the tubular body of the anchor and the extension of the anchor is between 1:0.3 and 1:0.7.

[0025] In some embodiments, the tubular body of the anchor has a chamfered distal edge to facilitate penetration of tissue with a needle.

[0026] In some embodiments, the tubular body of the anchor has a beveled distal edge to facilitate penetration of tissue with a needle.

[0027] In some embodiments, a tissue grabber is provided, comprising: a tubular body made of a resilient material and having a plurality of tines, wherein the tines are configured to expand outwardly when unbiased; a tube configured to surround the tubular body and the tines and to bias the tines so that the tines assume a tubular configuration; and an actuator configured to: (a) push the tubular body relative to the tube so that the tines leave the tube and penetrate tissue while expanding outwardly, thereby securing the tissue to the tines, and (b) pull the tubular body relative to the tube so that the tines enter the tube while releasing the tissue.

[0028] In some embodiments, the resilient material is a superelastic metal alloy wherein the tines are trained to a normal expanded configuration.

[0029] In some embodiments, the plurality of tines is 3-8 tines.

[0030] In some embodiments, the plurality of tines is 4-7 tines.

[0031] In some embodiments, the plurality of tines is 5-6 tines.

[0032] In some embodiments, each tine has a blunt edge.

[0033] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed descriptions. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Exemplary embodiments are illustrated in the reference figures. Dimensions of components and features shown in the figures are generally chosen for ease and clarity of presentation and are not necessarily shown to scale. The figures are listed below.

[0035] Figure 1A-1B A perspective view of a device for stapling tissue is shown.

[0036] Figure 1C A perspective view of an alternative device for suturing tissue is shown.

[0037] Figure 2A-2B Side and perspective views of the distal portion of the shaft with a grasper are shown.

[0038] Figure 2C-2F A perspective view is shown of an alternative configuration of gripping devices, each positioned alongside a needle.

[0039] Figures 3A-3H Various views of different anchors are shown.

[0040] Figure 4 A cross-sectional view of two anchors attached to tissue is shown.

[0041] Figure 5 A cross-sectional view of a distal portion of a device for suturing tissue disposed inside an endoscope is shown.

[0042] Figures 6A-6F Cross-sectional views of the various stages of anchor deployment into tissue are shown.

[0043] Figure 7A-7B Perspective and cross-sectional views of a guide shaft for separate advancement and deployment of an anchor and its extension are shown.

[0044] Figure 8 A perspective view of the distal portion of an alternative device for stapling tissue is shown with a needle housed within a jaw-type grasper.

[0045] Fig. 9 A perspective view with suture needle is shown.

[0046] Figures 10A-10B A perspective view of a screw ring acting as a gripping device is shown.

[0047] Figures 11A-11B A top isometric view of the two spiral rings is shown.

[0048] Figures 12A-12B A cross-sectional view of a sleeve arrangement is shown.

[0049] Fig. 12C Shows Figures 12A-12B Perspective view of the distal portion of the sleeve arrangement.

[0050] Fig.13A and 13B A perspective view of an anchor is shown.

[0051] Fig. 13C and 13D A perspective view and a side view of another anchor are shown.

[0052] Fig.14A and 14B Shows the use of Figures 12A-12B A perspective view of a general push operation performed by a ratchet mechanism of a sleeve arrangement.

[0053] Figures 15A-15C Shown with Fig. 12A -14C sleeve arrangement combined with shaft arrangement.

[0054] Fig.15D Shows Figures 12A-12B The sleeve arrangement and Figures 15A-15C Cross-sectional view of the shaft arrangement.

[0055] Figures 15E-15F A perspective view of the gripper is shown.

[0056] Figure 15G A cross-sectional view of the tines penetrating the stomach wall is shown.

[0057] Figures 15H-15M Perspective views showing six alternative configurations of the gripper.

[0058] Figures 16A-16D are cross-sectional views illustrating four stages of implantation of an anchor beyond tissue.

[0059] Fig.17A is a photo of a pig experiment using the fork-tine gripper.

[0060] Fig. 17B Here is a photo of another pig experiment using the fork-tine gripper.

[0061] Fig.18A and 18B A perspective view and a cross-sectional view, respectively, of the distal region of an alternative shaft arrangement are shown.

[0062] Figures 19A-19C A side view and two perspective views, respectively, of an alternative gripper in a closed configuration are shown.

[0063] Figures 20A-20C A side view and two perspective views, respectively, of an alternative gripper in an open configuration are shown.

[0064] Fig.21A and 21BShown are top and side views, respectively, of the distal region of one of the tines of an alternative grasper.

[0065] Fig. 21C A side view of an alternative grabber is shown with one of the tines in an expanded state.

[0066] Fig. 22 A plan view of a sheet of material from which an alternative gripper is made is shown.

[0067] FIG. 23A to FIG. 23C Side, front and enlarged views of the needle are shown.

[0068] Fig.24 A flow chart showing a method of suturing tissue.

[0069] Figures 25A-25D A side view of an alternative anchor is shown in a closed configuration.

[0070] Figures 26A-26C A side view of an alternative anchor is shown in an open configuration.

[0071] Fig. 27 A side view of another anchor is shown in an open configuration. DETAILED DESCRIPTION

[0072] Disclosed herein is a device for suturing tissue through a flexible endoscope, and a method for minimally invasive suturing of tissue using the device. The device can be used in various endoscopic procedures requiring full-thickness suturing of soft tissue to close, approximate, fix, fold and / or ligate tissue.

[0073] For example, the device can be used to perform various upper GI (gastrointestinal tract) and lower GI procedures in a minimally invasive manner, via a gastroscope or colonoscope. Invasive manner, i.e., by esophageal or rectal approach. Exemplary procedures include original sleeve gastroplasty or revision of existing sleeve gastroplasty, fistula closure, endoscopic submucosal dissection (ESD), endoscopic mucosal resection (EMR), peroral endoscopic myotomy (POEM), gastric bypass revision, stent or other prosthesis fixation, perforation closure or prevention, hemorrhage closure or prevention, lumen apposition, etc.

[0074] Advantageously, the relevant components of the device can be sized to fit within a single working channel (also referred to as an "active channel," "instrument channel," etc.) of an endoscope, thereby leaving one or more other working channels available for other tools needed during a procedure, such as various imaging, illumination, suction, irrigation, and / or tissue manipulation tools. The working channel can have an inner diameter of, for example, 2 to 8 millimeters (mm), and the relevant components of the device (e.g., its outermost shaft) can be sized and configured to fit within that space.

[0075] Advantageously, the device can deploy multiple anchors through which sutures (also referred to as "threads") are passed; the device, anchors, and sutures are configured in a manner that: (a) prevents or reduces friction damage to surrounding tissue, (b) allows tissue closure and / or approximation by convenient and simple pulling of the thread after the anchors have been satisfactorily deployed, (c) enables solid and secure tissue fixation, (d) reduces tension on the sutured tissue (compared to conventional manual suturing), thereby reducing tissue trauma and the risk of thread "cheese cutting", (e) does not form loops that wrap around tissue, thereby reducing the risk of nerve or blood vessel entrapment, (f) forces the movement to standardize suturing, thereby reducing variability between surgeons / endoscopists of different skill levels, (g) distributes suture tension among all anchors, (h) concentrates the force applied to the tissue at the junction between the tissue and each anchor, which has a surface area that is much larger than that of surgical thread (also referred to as "sutures"), and / or (i) enables simple, actuator-operated suturing - even at remote anatomical locations, requiring minimal expertise.

[0076] In the following description, the functions and uses of the various components described constitute a method of suturing tissue even if the terms "method" and "step" are not explicitly mentioned.

[0077] Reference Figure 1A and 1B , which shows a perspective view of a device 100 for suturing tissue according to one embodiment. The device 100 may include a handle 102 and a flexible shaft 104 extending from a distal end of the handle.

[0078] The shaft 104 can be a flexible elongated tube, made of, for example, plastic and / or braided metal. The length of the shaft 104 can be, for example, 200-3000 mm, wherein a portion of the length (e.g., between 10-300 mm) can be disposed inside the handle 102. The shaft 104 can have, for example, an outer diameter of 2 to 10 mm. The shaft 104 can have a uniform or variable diameter along its length.

[0079] The needle 108 may be disposed within the interior of the shaft 104 and may optionally have a beveled edge 110. Alternatively, the needle (not shown) may have a straight, non-beveled edge. Figure 1BIn the view of FIG. 1 , the needle 108 is shown protruding distally from the shaft 104. The needle 108 can be used to penetrate tissue to deploy the anchor beyond 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 its distal end (e.g., between 1-20 mm from the distal end), which is embodied as a resilient protrusion from the inner wall of the needle into the inner cavity of the needle-thereby reducing the inner diameter of the needle at this position. The stopper can protrude into the inner cavity of the needle 108 under normal circumstances, but can be pushed completely or partially out of the inner cavity when the anchor (discussed further below) applies a sufficient amount of force to it. The stopper can be constructed so that it can resist a predetermined amount of force.

[0080] Temporary reference Fig. 9 , which shows an optional embodiment of a needle 900 having a slit 902 at its distal end. The slit 902 can be configured to accommodate the suture 118 as the device moves from one anchor deployment location to another, and can prevent the suture from being cut when rubbed against the distal end of the needle. The slit 902 can be configured to have a smooth edge - which does not cause the suture to be cut when rubbed against the distal end of the needle, in contrast, a needle without such a slit (such as Figure 1A-1B The distal end of the needle 108 in the needle 108 may include a sharp edge that can cut the suture. The slit 902 may have a length of, for example, 1-30 mm and a width of, for example, 0.4-2 mm.

[0081] Back to Figure 1A-1B , a grasper 120 may also be disposed within the shaft 104, such as on the needle 108, and used to grasp tissue during the process of piercing the tissue with the needle and deploying the anchor. In the absence of such a grasping device, an attempt to pierce tissue with the needle alone may actually push the tissue away from the needle, especially in cases where the tissue is very soft, flexible, or wiggling. Although the needle may eventually pierce the tissue, this may occur only after the needle has significantly extended in the distal direction, which may result in damage to unintended organs, vessels, nerves, or other tissues. Therefore, it is beneficial to grasp the tissue with a grasper and secure it to the shaft 104 during its piercing process.

[0082] Optionally, the grasper 120 and shaft 104 are configured to move distally or proximally over or within the needle 108. The needle 108 may optionally be stationary relative to the handle 102, and thus, after the grasper 120 grasps tissue, the grasper may be withdrawn relative to the needle, keeping the needle in place and at the same position and distance from the tissue (and from any blood vessels, nerves, or other organs), thereby enabling safe tissue penetration.

[0083] Optionally, the shaft 104 can extend over the needle 108 and / or trachea 120 and cover them when in an endoscope or anatomical cavity, shielding the endoscope or anatomical cavity, respectively, from damage or injury. The shaft 104 can be made of plastic, metal and / or metal alloys, and is configured to have sufficient flexibility along its longitudinal axis so that it can adapt to the curvature of the endoscope in which it is housed.

[0084] exist Figure 1B In the view of , the grabber 120 is shown protruding distally from the shaft 104. The grabber 120 is configured as a tube, which is divided into a plurality of sharp grabbing tines (e.g., 2 to 10 tines, or more) at its distal portion for penetrating tissue. The grabber 120 can be made of a shape memory alloy (such as nitinol), and the grabbing tines can be trained to an expanded configuration in which they curl away from the central axis of the grabber, and optionally even curl in the opposite direction. When the grabber 120 is still within the shaft 104, the grabbing tines are biased into a retracted configuration in which they are arranged flat around the needle 108. When the grabber 120 is expelled distally and the grabbing tines leave the distal end of the shaft 104, they curl outward and penetrate the tissue facing the distal end of the shaft.

[0085] Figure 1C Device 100a is shown, which is a device 100 ( Figure 1A-1B ) in which the structure of the handle 102a is different. The handle 102a may 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 manipulating its shaft, needle, grabber, anchor pusher, and / or the like. However, the term "actuator" should not be construed as limited to such elements on the handle 102a; instead, the actuator can be any physical device that is connected to one or more parts (e.g., shaft, needle, grabber, anchor, pusher, inner shaft, outer shaft) of a device (such as, but not limited to, the device 100a) and is configured to move and / or hold the part stationary.

[0086] refer to Figure 2A-2B , which shows a schematic example of a distal portion of a shaft 104 having an alternative grasper embodiment, which is configured as a helical portion 120a. The helical portion 120a can be attached to, connected to, or integrally formed with the distal end of a hollow extension shaft 140, which can rotatably push the helical portion into and withdraw it from tissue. That is, the helical portion 120a can be screwed into tissue 130 to secure the shaft 104 to the tissue. Figure 2A , the helical portion 120a is shown extending from the distal end of the shaft 104 (and the needle 108 (not shown) is withdrawn within the extended shaft 140), which is the configuration when the helical portion has been threaded into the tissue 130. Figure 2B, the needle 108 is shown extending through and beyond the helical portion 120a, which is the configuration when the anchor is deployed on the opposite side of the tissue from the opening of the needle.

[0087] Although the helix 120a is shown having approximately three complete rotations around the central axis of the helix (i.e., approximately 1080 degrees), alternative helices (not shown) may have anywhere between a quarter complete rotation (90 degrees) or 20 complete rotations. Additionally, although the helix 120a is shown as a single helix, alternative helices (not shown) may be double helices or even triple helices wrapped around the same central axis.

[0088] refer to Figure 2C-2F , which schematically illustrates alternative configurations of capture devices within shaft 104, each being disposed alongside (rather than above) the needle.

[0089] exist Figure 2C In the figure, a single helical segment is shown alongside the needle.

[0090] exist Figure 2D In the figure, the two helices are shown side by side with the needle.

[0091] exist Figure 2E , an expandable helical portion is shown alongside the needle. The helical portion may be made of, for example, a shape memory alloy (e.g., Nitinol) that is trained to a diameter greater than the radial space it occupies when it is alongside the needle inside the shaft 104. When the helical portion leaves the shaft 104, it expands to a larger diameter and thus occupies, for example, Figure 2C The spiral portion of the needle 104 can better grasp the tissue than the spiral portion of the needle 104 (assuming the shaft and needle are of the same size). Optionally, such a spiral portion can be gradually pushed out of the shaft 104 and penetrated into the tissue, so that it gradually stretches the tissue during penetration. The benefits of stretching tissue in addition to grasping tissue will be discussed below with reference to the spiral ring grasper.

[0092] exist Figure 2F , a grabber similar to grabber 120 configured with fork tines is shown alongside a needle.

[0093] Optionally, the device 100 includes a coil protection sleeve (not shown) configured as a tube surrounding the coil 120a but within the shaft 104. The sleeve can be advanced distally to cover any section of the coil 120a that is disposed beyond the needle 108 (e.g., beyond its beveled proximal end) and is not within the tissue; this section may be susceptible to entanglement of the suture 118 between the turns of the coil, and thus the sleeve acts to physically isolate the suture and the coil and prevent or reduce the possibility of entanglement.

[0094] Any of the helical portions discussed above may be made of, for example, metal, metal alloys, or plastic, and configured to be strong enough to pass through tissue without breaking or significantly plastically deforming.

[0095] refer to Fig. 10A , which shows yet another grabber embodiment, which is structured as a spiral ring 1000. The spiral ring 1000 can have a basic tubular shape, with an inner diameter configured to allow the spiral ring to be mounted on the needle 108, and an outer diameter configured to allow it to be set within the shaft 104. The wall of the spiral ring 1000 can include a plurality of cutouts (such as three cutouts, as shown in this example), which generally extend downward from the upper end of the wall of the tube and form a corresponding number of spiral pointed blades, such as three blades 1000a-c, therebetween. A larger number of blades is also possible, such as 2 to 7 blades. Each cutout can terminate proximally at a smooth, optionally rounded end 1002 - which is configured to accommodate the suture (if it happens to pass between the blades during any part of the procedure) without cutting it.

[0096] Fig. 10A The left side of the figure shows the spiral ring 1000 in a retracted configuration, wherein the blades 1000a-c define a substantially uniform tubular shape, while the right side of the figure shows the spiral ring 1000 in an expanded configuration, wherein the blades protrude radially. The spiral ring 1000 can be made of a shape memory alloy (such as Nitinol) that is trained to an expanded configuration so that the spiral ring can be biased to a retracted configuration when inside the shaft 104, and expand when becoming unbiased - when away from the shaft.

[0097] In operation, the shaft 104 can be brought into contact with or close to the tissue, and then pushed distally while rotating the spiral ring 1000. The pointed edges of the blades 1000a-c then penetrate the tissue and gradually stretch it as the blades continue to expand and rotate. That is, the spiral ring 1000 can simultaneously grasp the tissue and stretch it. Stretching the tissue can make it thinner in the stretched area, thereby requiring less distal movement of the needle 108 to fully penetrate the thickness of the tissue. In addition, when the tissue is stretched from two or more sharp points (the pointed edges of the blades), it will tend to remain substantially parallel to these sharp points, and therefore substantially parallel to the distal opening in the shaft 104; this will ensure that the needle 108 can penetrate the tissue substantially perpendicular to the tissue, and reduce the risk of the needle approaching the tissue at an obtuse angle without penetrating it sufficiently or not penetrating it at all. In addition, this can help require less force to push the needle to pierce the tissue, and / or help to be able to use a needle with a lower sharpness with the same thrust (thereby reducing the risk of damage to other organs or tissues by the tip of the needle).

[0098] After the anchor is deployed and the needle is retracted, the tissue can be released by pulling the spiral ring 1000 back into the shaft while rotating the spiral ring in the opposite direction. This will gradually return the tissue to a resting state while eventually disengaging the pointed edges of the blades 1000a-c from the tissue. Optionally, the needle 108 remains stationary while the spiral ring 1000 is advanced distally from the shaft 104 past the needle. The spiral ring 1000 can be rotated to be released from the tissue, as described above, and withdrawn into the shaft 104. Upon withdrawal, the blades will gradually return to their retracted configuration, presenting a generally tubular shape together.

[0099] Reference Fig. 10B , which shows an alternative spiral ring 1010 in which the shape of the cutout in the tubular body is similar to Fig. 10A The blades are different in diameter, thereby forming pointed blades of different shapes. This is an intended example, and in general, a spiral ring-type grasper can be configured with blades that allow a desired level of tissue penetration and tissue stretching corresponding to the desired degree of distal push and rotation of the spiral ring. For example, the pitch angle of the spiral upper region of the blade can affect the trade-off between tissue penetration and required rotation: a smaller pitch angle will generally penetrate the tissue at an obtuse angle, and the firmness of the grasped tissue per unit of a certain penetration depth is higher, but more rotation is required to reach the depth, while a larger pitch angle will generally penetrate the tissue at an acute angle, and the firmness of the grasped tissue per unit of a certain penetration depth is lower, and fewer rotations are required to reach the depth. As another example, the degree of radial expansion of the blade when unbiased can affect the amount of stretching experienced by the tissue pushed distally by the spiral ring for each certain length: more radial expansion basically means less distal push to achieve the same degree of stretching. There is also an interaction between the radial expansion of the blade when unbiased and the pitch angle of the spiral upper region of the blade.

[0100] In general, the pitch angle and / or radial expansion may be set for the suturing task at hand, such as the thickness, flexibility, and penetration resistance of the tissue involved.

[0101] Reference Figures 11A-11B , which is a top isometric view of spiral ring 1010 and a different spiral ring 1020 in their expanded configurations, showing various parameters of possible embodiments of the spiral rings. For ease of illustration, the bases of the two spiral rings have equal inner diameters. However, the configuration of their blades is different, which affects the way these blades penetrate and stretch tissue.

[0102] First, the blades can extend to a certain overall diameter when expanded, with the larger of spiral ring 1010 and the smaller of spiral ring 1020. This expanded diameter can be derived from the training of the shape memory alloy and / or the cut shape of the blades. The expanded diameter can affect the amount of stretching that the tissue will experience, but is not the only parameter involved in stretching, as further described below.

[0103] Secondly, the posture of the expanded blades can define the diameter of the circular thread of the blades in the tissue. Fig. 11B 11 , the blades of spiral ring 1020 together present a generally circular shape, defining a thread diameter that is generally the same as the expanded diameter of the blades. As spiral ring 1020 gradually expands as it penetrates the tissue, it can gradually stretch the tissue in an attempt to present its unbiased expanded diameter. However, in FIG. 11 , the blades of spiral ring 1010 curl inwardly from the expanded diameter at its edges, each forming its own smaller thread diameter. When such spiral ring 1010 is penetrated into tissue while expanding, its stretching of the tissue may be different from the stretching achieved by spiral ring 1020.

[0104] Another relevant parameter may be the wall thickness of the spiral - at least along the area where it is trained to bend. This parameter may affect the expansion force exerted by the spiral. In general, thicker walls of a shape memory alloy spiral may impart a stronger expansion force to the spiral, and vice versa. This in turn may affect the amount of tissue stretching that the spiral can achieve.

[0105] Thus, different spirocyclic embodiments may each have different combinations of such parameters, and all such possible combinations are expressly intended herein.

[0106] The base diameter may measure, for example, 0.5 to 15 mm. The expanded diameter may measure, for example, 0.8-30 mm. The individual blade thread diameter, if different from the expanded diameter, may measure, for example, 0.5-29 mm. The wall thickness - at least along the spiral ring area that is trained to bend (and optionally along the entire spiral ring) - may measure, for example, 0.1-4 mm.

[0107] Throughout this disclosure, the generic term "grabber" or even "grabber 120" is intended to also refer to the spiral portion 120a or the spiral ring 1000 / 1010 (mutatis mutandis).

[0108] The terms "push", "pull", "advance", etc. are used herein to describe the relative movement of two or more components of a device. For example, when describing the "advancement" of a needle, the needle may be physically manipulated to move forward relative to the handle, or the needle may remain stationary relative to the handle, but one or more other components of the device may be withdrawn relative to the needle so that it assumes a more forward position. The same principles apply to other parts of the device.

[0109] Refer to Figures 1A-1C, the handle 102 may include one or more user-operable actuators, such as, but not limited to, one or more triggers 106a and / or 106b and a button 106c. These user-operable actuators may be configured and acted to manipulate the shaft 104, the needle 108, the grabber 120, and / or deploy anchors. For example, the trigger 106a may be used to push the grabber 120 out of the distal end of the shaft so that the grabber engages the tissue. The button 106c may be used to retract the grabber 120 back into the shaft 104 while pushing the needle 108 into and through the tissue. The trigger 106b may be used to push the anchors out of the distal end of the needle 108 one by one; for example, each full swing back of the trigger 106b may push a single row of anchors by an equivalent length (or similar length) of one anchor. These are merely examples of the functions of the user-operable actuators included in the handle. In other embodiments, the various user-operable actuators may be configured differently.

[0110] A plurality of anchors may be arranged in a single file within the needle 108 (or on the needle - its configuration is not shown in the figure). Optionally, a spacer may be arranged between each two adjacent anchors to ensure that when one anchor is pulled out of the needle 108, the anchor behind it does not extend from the distal end of the needle. The spacer may or may not pass through the suture 118. It may be made of a bioabsorbable material so that it is absorbed and consumed in the body. Optionally, if the suturing operation is gastrointestinal, the retraction device may be configured so that the spacer is left in the cavity of the esophagus, stomach or intestine after the anchor is deployed so that it is naturally discharged from the body later with other fecal matter. Optionally, the spacer may help prevent the ejected anchor from being accidentally retracted into the needle 108.

[0111] Figures 3A-3H Exemplary anchors 112a - 112d (hereinafter collectively referred to as "anchors 112") are shown. Figure 3A A first exemplary anchor 112a is shown. Figure 3B A second exemplary anchor 112b is shown. Figure 3C-3E An exploded view, expanded configuration, and retracted configuration of a third exemplary anchor 112c are shown. Figure 3F-3H An expanded configuration, a retracted configuration, and an expanded configuration bottom view of a fourth exemplary anchor 112c are shown.

[0112] Each anchor 112 can have an elongated body 113a-c, hollow or solid, made of a rigid or flexible material, such as stainless steel, nitinol, titanium and / or a plastic, such as polyetheretherketone (PEEK), (permanent or bioresorbable). The elongated body can have a maximum outer diameter of, for example, 0.5-5 mm and a length of, for example, 2-15 mm. If hollow, its wall thickness can be, for example, between 0.1-1 mm.

[0113] Flexible or rigid extensions may emerge from the anchor 112. Figure 3A-3B As shown, the extension may be a cord 114a, for example, made from surgical thread (sometimes referred to as "surgical suture"), or a flexible wire.

[0114] like Figure 3C-3H As shown, the extensions may be flexible or rigid rods 114b-c (straight, curved, spring-coiled, etc.) made of a suitable material (such as one of the materials mentioned with respect to the anchor body).

[0115] Any of the extensions 114a-c is optionally also stretchable along its longitudinal axis. Each of the extensions 114a-c may have a circular profile or a non-circular profile. Each extension 114a-c may be attached to, connected to, or integrally formed with the anchor 112. Each extension 114a-c may have a diameter or width (as appropriate) of, for example, 0.1-2 mm, which may be uniform or variable along its length.

[0116] Optionally, any of the extensions 114a-c is formed as a resilient element that is attached, connected, or integrally formed with the anchor 112 vertically (or substantially vertically, such as forming an angle between 60-90 degrees with the anchor). In this manner, when the anchor 112 is within its receiving cavity (e.g., the needle 108 or the shaft 104 - in the case where the anchor is passed over the needle), the extensions 114a-c are biased to be disposed parallel or substantially parallel to the anchor (e.g., between 150-180 degrees relative to the longitudinal axis of the anchor); this can increase the friction between the cord and the inner wall of the needle, preventing the anchor from being accidentally pulled out of the device. Subsequently, when the anchor 112 is pulled out of the needle 108, the extensions 114a-c assume their unbiased vertical posture. This posture ensures that the anchor 112 will be flat or substantially flat against the distal side of the tissue after the suture is tensioned and secured.

[0117] Optionally, any of the extensions 114a-c is formed as a rigid element that is pivotally connected to the anchor 112, thereby allowing the extension to rotate between an expanded configuration (in which it is upright perpendicular or substantially perpendicular to the anchor) and a retracted configuration (in which it is positioned parallel or substantially parallel to the anchor).

[0118] exist Figure 3A-3B In the embodiment of the present invention, the main body 113a of the anchor 112a-b is similarly a hollow tube with a circular profile. The rope 114a forms a loop outside the main body 113a. Inside the main body 113a, the two ends of the rope 114a (not shown) can be tied or otherwise fastened together, and / or fastened to the main body separately.

[0119] Figure 3B Anchor 112b is shown, which is Figure 3A The anchor 112a of the present invention is similar to most of the anchors 112a of the present invention, but has an optional function - one or more resilient wings 115, which are biased to be flush with the anchor when the anchor is located inside the needle 108, but are deployed and expanded after the anchor is pulled out of the needle. Each resilient wing 115 can be an arcuate wire made of a superelastic material (such as Nitinol) or an elastic material (such as stainless steel, cobalt-chromium alloy (CoCr), etc.). Optionally, the resilient wing (not shown) can be formed integrally with the anchor, such as a cutout in the wall of the anchor - it is trained to expand radially outward when there is no bias. The wing 115 makes the anchor 112b wider than the diameter of the needle 108 in at least one plane when expanded, which prevents the anchor 112d from falling back into the needle after it has been pulled out of the needle. In some embodiments, the wing 115 can also provide friction between the anchor 112b and the inner wall of the needle 108 so that the frontmost anchor 112b in the needle will not be accidentally pulled out. Although wing 115 is shown in conjunction with anchor 112b (which is otherwise similar to anchor 112a), it may also be implemented with any of anchors 112b-d or with any other anchor discussed but not exemplified herein. In addition, the expansion function of the anchor after it is withdrawn from its device, and / or the friction between the anchor and its receiving cavity (e.g., a needle), may be implemented differently than the wings shown. For example, it may be achieved by at least one resilient extension that is configured to lie flat or substantially flat against the anchor when biased and expand to a distance of 0.5 to 5 mm from the anchor when withdrawn from the receiving cavity.

[0120] exist Figure 3C-3EIn the embodiment of the present invention, the anchor 112c has a tubular body 113b with a longitudinal cut from one end of the tubular body to about the middle of its length or slightly beyond the middle. A tab 114b is pivotally connected to the body 113b--a pair of protrusions at one end of the tab that fit into a matching hole in the wall of the body. Holes are provided at or near the opposite ends of the tab 114b for suture 118 to pass through the tab. When the anchor 112c is provided inside the needle 108, the tab 114b remains fully or partially retracted inside the body 113b. After the anchor 112c is ejected from the needle 108, the tab 114b can be rotated to present a vertical or substantially vertical posture relative to the body 113b. Optionally, the anchor 112c (or any other anchor) can include an extension locking mechanism (not shown) that is configured to lock the extension in a vertical or substantially vertical position relative to the anchor body. For example, the locking mechanism may be configured to automatically lock the extension after the extension reaches a vertical or substantially vertical position.

[0121] exist Figure 3F-3H In the embodiment, the anchor 112d has a tubular body 113b with a lug 114c, which is different from Figure 3C-3E , which is cut from the tubular body itself. The rotation of this lug 114c is performed by bending the material of the tubular body 113b at the lug starting area. This bending can be plastic deformation or elastic deformation, depending on the material made of the anchor 112d. Holes are set at or near the opposite ends of the lug 114c for passing the suture 118 through the lug. The anchor 112d can be made of, for example, a shape memory alloy (such as nitinol), which is trained to bend the lug 114c to a vertical or substantially vertical posture relative to the body 113b. In this way, the lug 114c can be biased to a retracted configuration when it is inside the needle 108, and will rebound to its training posture when it is pulled out of the needle-thereby preventing the anchor 112d from being accidentally pulled back into the needle.

[0122] In a further arrangement of the anchor (not shown), the extension may be provided by a single strand of cord extending from the anchor body and having loops tied or attached at opposite ends thereof.

[0123] Optionally, the hole, loop or ring of any of the anchors 112a-d is smooth and free of any sharp edges, thereby preventing or reducing damage to the suture 118 and tissue caused by friction with the hole, loop or ring. Such smoothing may be achieved by appropriate surface treatment and / or by coating at least the inner surface of the hole, loop or ring with a smooth material (optionally a polymer). Optionally, additional loops are connected to extensions of any of the above-mentioned anchors, such as Figure 3A , 3D3F and the annular smooth loop 116 shown in dashed line. Suture 118 can be passed through loop 116 instead of through the extension, and the smoothness of the loop surface can further reduce friction and prevent suture damage. In an alternative configuration (not shown), the low friction loop can be not annular, but have a different shape that still has no sharp edges that can damage the suture.

[0124] Figure 4 Two anchors 112a are shown attached to tissue 130, and cord 114a fully penetrates the tissue and connects suture 118. Anchors 112a can be attached to tissue 130 so that cord 114a pierces the tissue to extend from the opposite side thereof. Suture 118 can be passed through the loop of cord 114a on the opposite side of tissue 130 so that when the suture is tightened, the portion of the cord extending from the tissue can bend to prevent damage to the tissue. Figure 3B-3H The anchors 112b-d in may function similarly.

[0125] To eject the anchors 112 one by one from the shaft 104, the device 100 may include a pusher, such as a rod (not shown) disposed inside the needle 108 that pushes the single row of anchors from behind the most proximal anchor.

[0126] As an alternative to pushing all anchors 112 at once from the rear, in order to cause the ejection of the distal-most anchor, the device 100 may include a different pusher (not shown) configured to push only the distal-most anchor. For example, such a pusher may be set on (or inside) a single row of anchors without contacting all anchors except the distal-most anchor. The contact between the distal end of such a pusher and the distal-most anchor may make it possible to facilitate the distal pushing of the anchor by pushing the pusher distally to a distance sufficient to eject the anchor from the needle 108. The pusher may then be retracted rearward so that it can push the next anchor when needed.

[0127] Now return to reference Figure 1A-1B A suture 118 (not shown in these figures) may be disposed within the needle 108 along its length and optionally exit from the distal end of the needle. The suture 118 may be threaded sequentially through loops or loops of anchors disposed in series within the needle 108. The suture 118, at its proximal region, is optionally wound on a spool (not shown) disposed within the handle 102.

[0128] Suture 118 is optionally a surgical thread (sometimes referred to as a "surgical suture"), which can be bioabsorbable or non-bioabsorbable. Suitable bioabsorbable materials include, for example, polyglycolic acid, polylactic acid, monocryl and polydioxanone. Suitable non-bioabsorbable materials include, for example, nylon, polyester, PVDF (polyvinylidene fluoride) and polypropylene. Suture 118 can be a braided thread, a monofilament thread or a multifilament thread. Suture 118 can be made of metal or plastic or any biocompatible material. Suture 118 can be stretchable or substantially non-stretchable.

[0129] The suture 118 is optionally fixed at one end thereof to a spool at the handle, from which it extends successively through the loops or loops of all anchors. The other end of the suture 118 can remain unattached, or be attached (e.g., by knotting, adhesive, cinch, etc.) to the most distal anchor. The latter means that after a series of anchors have been deployed, the suture 118 can be cut at a proximal position of the last deployed anchor, and the new proximal end of the suture 118 can simply be pulled to tighten the suture extending through the deployed anchors; the new proximal end can then be fixed to the last anchor deployed - by manually tying a knot or cinch, which prevents the suture from sliding through the loop or loop of the anchor.

[0130] Optionally, the attachment of suture 118 to the distal-most anchor may be unidirectional, such as by forming a large knot in the suture itself distal to that anchor, so that the anchor cannot slide further distally but only proximally. Further optionally, after two or more anchors have been deployed and their sutures have been cut, tensioned, and secured, the device 100 may be prepared for further suturing operations (assuming at least two anchors remain in the device) - by forming a suture knot distal to the current distal-most anchor within the shaft 104 (with the suture still in the device, of course), which enables tensioning and securing in the same manner as described above.

[0131] Optionally, the device 100 includes a suture cutting mechanism, such as a sharp blade (not shown), for cutting the suture 118 at a location proximal to the last deployed anchor.

[0132] Beneficially, the fact that the suture is not passed through the body of the anchor but rather through a loop or ring that is distal to the body of the anchor and not implanted in the tissue prevents the suture from exerting forces on the tissue, which in extreme cases could even cut the tissue.

[0133] Furthermore, the spacing of the loop or ring from the anchor body reduces stress from the anchor body and concentrates the stress at the loop or ring and slightly along the cord when the suture is tensioned to ultimately close the tissue.

[0134] Still further, the use of anchors means that there is a larger implant surface area, which can resist the forces that attempt to pull the anchors out of the tissue. If only sutures are used, the only surface area to secure the sutures is the sutures themselves - which is very small. It is known that mucosal tissue (such as that of the stomach) is particularly difficult to suture. It is not usually well secured with sutures or clamps. In addition, high-tension sutures of such tissues usually cut the tissue, and even if the tissue manages to maintain its integrity, sutures can sometimes cause ischemia and necrosis. Therefore, suturing mucosal tissue (and other types of soft, easily torn tissues) using the anchors disclosed herein can overcome these problems and allow for durable tissue closure, approximation, etc. without damaging the tissue. On one side of the tissue, the sidewalls of the anchors contact the tissue along the longitudinal dimension of the anchors and disperse the force over a large area; on the other side of the tissue, the force that pulls the anchors toward the tissue is distributed across the entire suture that connects all the loops or loops of the anchors to each other. Furthermore, the tightening of the suture is performed in a frictionless environment - outside the soft tissue and through the loop or loop - whose inner surface is smooth and creates very little friction with the suture. In this way, even if the suture occasionally rubs against the surface of the loop or loop during the patient's recovery period, it will not tear or otherwise degrade the suture.

[0135] After all anchors are implanted and the suture is tensioned, it can be tied manually by tying a knot, or secured by a drawstring (not shown). If both ends of the suture are free after implantation, the drawstring used can be a connector mounted on both suture portions that does not allow them to move relative to each other (or the suture portions pass through the drawstring). If the distal end of the suture has been secured to the first implanted anchor and only the proximal end of the suture remains free, the drawstring used can be a device that is mounted on the suture by friction and pushed against the loop of the last implanted anchor.

[0136] The placement of the band over both suture portions or a single suture portion can be performed using a separate tool manipulated by the surgeon (through an endoscope), or by a function in the device itself that can be triggered by a handle. The band is optionally unidirectional, i.e., it can only slide distally, but not proximally, after being installed over the one or both seam-defining portions. In this way, the sliding of the band assists in suture tensioning and ensures that the tension is not accidentally loosened.

[0137] Reference Figure 5, which shows a cross-sectional schematic example of a distal portion of the device 100, with its shaft 104 disposed within the working channel 502 of the endoscope 500. According to one embodiment, one of the other channels 504 of the endoscope 500 optionally serves as a suction chamber. In this embodiment, a suction cup 506 can be mounted on the distal portion of the endoscope 500 to enable a larger tissue area to be sucked into the gap 508 of the suction cup. When suction is activated, the tissue is pulled into the gap 508 and pulled toward the distal end of the shaft 104. The diameter of the distal opening of the suction cup 506 can be, 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, between 3 and 20 mm. The volume of the gap 508 can be, for example, between 1-40 cc (cubic centimeters).

[0138] Optionally, suction can also enable tissue to be held at a distance from adjacent organs, which can be damaged if the grasper 120 or needle 108 accidentally penetrates the adjacent organs. Optionally, after the suction chamber 504 provides suction, the grasper 120 is used to more firmly attach the shaft 104 to the tissue. Optionally, after the grasper 120 secures the tissue, the suction can be turned off until the next use. Optionally, the suction can be operated by a controller (not shown), which is configured on the handle 102 or as a foot switch (not shown), etc.

[0139] As an alternative to the suction lumen 504, the shaft 104 or needle 108 itself may serve as the suction lumen. That is, the shaft 104 or needle 108 may be connected to a suction source at its proximal side to enable tissue suction at its distal side.

[0140] In other embodiments, working channel 504 is not used for tissue aspiration, and suction cup 506 is not present. Instead, working channel 504 (and optionally one or more additional working channels) can be used, for example, for inserting a camera, illuminator, fiber optics, and / or surgical tools.

[0141] Reference Figures 6A-6E , which shows that according to one embodiment, Figure 1A-1B 1 and 10. The apparatus 100 is shown in cross-sectional views at various stages of deploying the anchor 112 into the tissue 130. For simplicity of illustration, the endoscope through which the shaft 104 is inserted is not shown in these figures.

[0142] The distal end of the shaft 104 of the device can approach and contact tissue 130 ( Fig. 6A To do this, an endoscope (not shown) may be held in place while shaft 104 is pushed slightly outside the endoscope. When shaft 104 is aligned with the tissue, grasper 120 may be extended outside shaft 104 and penetrate tissue 130 ( Figure 6B ). The needle 108 is then extended out of the shaft 104 through the fixed tissue 130 ( Figure 6C The anchor 112 may then be deployed via the needle 108 to the opposite side of the tissue 130 ( Fig.6D Finally, the grabber 120 and needle 108 can be retracted into the shaft 104 and the device moved back ( Fig. 6E ), leaving the anchor within the tissue 130.

[0143] exist Figures 6A-6E In the embodiment shown, the suture 118 is freely passed through the loop / loop of the most distal anchor. This requires pulling on both sides of the suture to tighten it after implanting the multiple anchors required for the suturing task. In an alternative embodiment (not shown), the suture can be permanently fixed to the loop / loop, such as with a knot or connector, so that the final tightening of the suture only requires pulling on its proximal side.

[0144] Figures 6A-6E The optional feature shown in is a deflector 108a, which is arranged at or near the opening of the needle 108. The deflector 108a can be a protrusion from the inner wall of the needle 108, the purpose of which is to deflect the pop-up anchor in the opposite direction. For example, when the deflector 108a is positioned on the upper side of the needle 108, it will deflect each pop-up anchor downward. The deflection tilts the pop-up anchor relative to the central axis of the needle 108 and the shaft 104, so that when it is withdrawn backward, the anchor will not be withdrawn therewith, but will remain on the opposite side of the tissue. The deflector 108a can be shaped as a wedge, and the surface of the anchor in contact with the needle 108 and the central axis of the shaft 104 forms an acute angle (for example, between 10 degrees and 60 degrees). The deflector 108a can also serve as the stopper discussed above.

[0145] Fig. 6F A variation of the use of the device 100 is shown in which, after the grasper 120 is secured to the tissue 130, the device (or at least its shaft) is pulled proximally along with the secured portion of the tissue. This creates a space distal to the tissue that is likely free of other tissue or organs, so that extension of the needle and deployment of the anchor will not damage these tissues / organs. For example, when using the device 100 to suture the stomach wall, pulling the stomach wall before the needle penetrates the stomach wall can reduce the likelihood that the needle will puncture one of the many blood vessels surrounding the stomach, pancreas, etc.

[0146] The device 100 (eg, Figures 6A-6FAn example of the use of the device 100 (as shown) can be to perform an endoscopic sleeve gastroplasty. For example, the shaft 104 of the device 100 can be inserted into the patient's stomach through an endoscope, and initial marks are made on the anterior and posterior walls of the stomach along the greater curve before this to provide a guide line for the suturing procedure. The device 100 can then deploy a first anchor at a distal position along the stomach wall where the sleeve begins (e.g., on the distal anterior or posterior wall). Optionally, the device 100 can start suturing from a distal position of the stomach, for example, near the pyloric portion, and continue from there in a proximal direction. Additional anchors can be attached to the anterior wall, the greater curve wall, and the posterior wall of the stomach to form a desired suture profile, such as a triangular suture configuration. The suture pattern can be performed by attaching, for example, 2-6 anchors to create an anchor group. After completing the 2-6 attachments, the suture can be tightened and tied (or otherwise fixed without tying). Optionally, the suture can be tightened only after the additional attachment along the greater curve is completed. A similar pattern can be performed by attaching several more anchors along the guide line near the proximal end of the stomach, such as 4-10 anchor units, to maximize the reduction in stomach size.

[0147] Another example use of the device 100 is in performing a revision for bariatric treatment in the stomach after a sleeve gastroplasty. A revision may be required as the sleeve expands over time. To perform the revision, a suture route may be placed within the stomach along the previous sleeve gastroplasty suture route to further reduce the volume of the stomach. The new suture route may extend along the new (after the sleeve gastroplasty) larger curve of the stomach.

[0148] Another example of using the device 100 is for outlet revision. In some cases, after a gastric bypass is performed, the outlet can expand, reducing the effectiveness of the bypass. To reduce expansion, the outlet circumference of the gastric bypass outlet leading to the bypass tunnel can be reduced. The device 100 is used to suture the outlet. Anchors can be attached to the stomach wall at the outlet, and the sutures can be tightened to narrow the diameter of the outlet. This can be done at multiple longitudinal locations along the expanded outlet.

[0149] Another example of using the device can be to seal a perforation of the stomach, intestines, or any other luminal portion of the gastric system. The procedure can be performed by attaching (one) anchor at the edge of the perforation. A second anchor can be attached to the opposite edge of the perforation. Additional anchors can be attached to create a cross-shaped suture pattern across the perforation, such as two or four additional sutures. After attaching the anchors, the sutures attached to the anchors are pulled to create tension, thereby sealing the perforation.

[0150] Figure 7A-7BAn internal guide shaft 700 is shown, which is optionally housed within the needle 108 and includes two internal channels terminating in two corresponding openings 702 and 704 for separate advancement and deployment of the anchors and their extensions. The two channels may be longitudinally interconnected (to facilitate interconnection between each anchor and its tether), but still allow a series of anchors 112 to move along one channel, and a series of extensions 114 (and wires 118) to move separately along the other channel, keeping these elements separate and preventing sutures 118 from becoming tangled with the anchors 112 and / or their extensions 114.

[0151] Figure 8 The distal portion of an alternative device 800 for suturing tissue is shown, wherein the needle 108 is contained in a clamp-type grasper. Such a grasper may include two (or more) clamps 802a and 802b, which are constructed to allow the needle 108 to be located between them when they are closed. The base of the clamps 802a and 802b, where they are connected to the shaft 104a, includes an opening of an elongated channel extending within the shaft and accommodating the needle 108. The needle 108 can move in the channel in the distal and proximal directions. For example, the distal portion of the device 800 can first be advanced toward the tissue to be sutured, while the needle 108 is still completely contained in the channel in the shaft 104a. Then, the clamps 802a and 802b are opened to surround some tissue and closed on the tissue to grasp it. Then, the needle 108 is pushed through the channel distally so that it penetrates the tissue. The needle 108 is advanced distally until its distal opening reaches beyond the tissue. The anchors (shown in phantom within needle 108) are then pushed distally until the forward-most anchor is pulled out of the needle into the space beyond the tissue.

[0152] Finally, needle 108 is retracted into the channel in shaft 104a, jaws 802a and 802b are opened, and the distal portion of device 800 can be repositioned to deploy the next anchor at a different location in the tissue.

[0153] Optionally, the shaft 104a of such a grasper may be housed within an external shaft, such as shaft 104 in the previous figures. Optionally, the shaft 104a may pass directly through the working channel of an endoscope.

[0154] In any alternative configuration of the device for suturing tissue, it can be configured for partial thickness suturing of soft tissue, instead of full thickness suturing. In this configuration, the needle can only penetrate a portion of the thickness of the tissue, and the anchor can be deployed inside the tissue (or partially inside the tissue), instead of exceeding the tissue.

[0155] Furthermore, although the shaft, needle, grabber, and grabber protection sleeve are shown throughout most of the figures as having substantially concentric profiles, one or more of them may be configured to have an eccentric profile instead.

[0156] Reference Fig. 12A , which shows a cross-sectional view of a sleeve arrangement 1200 that may serve as an alternative to the shaft described above (labeled 104 or 104a in other figures), or may be located within such a shaft, replacing at least some of its internal components, such as its anchors and sutures. Fig. 12B , which is Fig. 12A An enlarged view of the distal portion of the sleeve arrangement 1200.

[0157] Advantageously, the sleeve arrangement 1200 may include an internal ratchet mechanism that allows for unidirectional pushing of an anchor such as anchor 1204 in a distal direction. The ratchet mechanism may include a push rod 1206 extending longitudinally along the sleeve arrangement 1200 and having a plurality of protrusions 1206a disposed (optionally equidistantly) along its length. Each such protrusion 1206a may be connected to, attached to, or integrally formed with the push rod 1206 such that it is fixed to the push rod when moved. Each protrusion 1206a may be configured to have a generally conical shape, with the wider side of the cone pointing distally and the narrower side of the cone pointing proximally. Thus, when the push rod 1206 is pushed distally or pulled proximally, the projections 1206a move accordingly; when the push rod is pushed distally, each projection pushes its corresponding anchor 1204, and when the push rod is pulled proximally, each projection passes its corresponding anchor until it is immediately behind it, ready for the next pushing operation, as will be discussed further below.

[0158] An alternative ratchet mechanism (not shown) may include a one-way extension on each anchor, such as a fin extending outwardly and proximally from the anchor, and a series of matching protrusions on a sleeve or other tube surrounding the anchor. In this manner, the anchor can only move forward (distal) within the tube, but not backward (proximally). This one-way extension may also help prevent the anchor from returning through a tissue hole after having been implanted beyond the tissue.

[0159] The sleeve arrangement 1200 may include a sleeve 1202 made of a flexible material, such as polytetrafluoroethylene (PTFE, commercially known as ) or the like. Anchors 1204 may be positioned (optionally equidistantly) inside sleeve 1202, and suture 1208 passed therethrough and also disposed within the sleeve.

[0160] Sleeve 1202 can be configured with structural weakening modifications at various areas where anchors 1204 will reside, so that when push rod 1206 is not moving, the anchors become relatively fixed in these areas. These structural weakening modifications can be, for example, elongated slits, such as slit 1206b, which are located at the Fig. 12B Show, but in Fig. 12C It is more clearly visible in the figure, which is temporarily referenced. Fig. 12C A perspective view of the distal portion of sleeve 1202 is shown, corresponding to Fig. 12A and 12B . As shown, sleeve 1202 includes slits 1206b along the area where the most distal anchors (not shown in this figure) are disposed. The length of each slit 1206b can be equal to ±25% of the length of each anchor. Slits 1206b weaken the structure of sleeve 1202 and allow its diameter to expand slightly when anchors are disposed in the slit area.

[0161] Reference Fig.13A and 13B , which shows the anchor 1204 in more detail. Fig.13A , the anchor 1204 is shown when the extension 1204a is flush with the anchor body, and when Fig. 13B , the anchor is shown when the extension appears perpendicular to the main body.

[0162] Anchor 1204 can be generally similar to anchor 112d described above (see Figure 3F-3H ). The anchor 1204 may have an elongated body and a flexible extension 1204a emerging therefrom, as described above with respect to the anchor 112d. However, the anchor 1204 may include a feature at its proximal side that enables it to be pushed unidirectionally by the ratchet mechanism of the sleeve arrangement 1200 described above: the outer circumference of the hollow body of the anchor at its proximal side may not be a complete circle, but rather a pair (or more) of concave and resilient "legs" 1204b-c that point toward each other and define an inner diameter therebetween (at its proximal end) that is slightly (e.g., 5-30%) smaller than the rest of the anchor body. This smaller inner diameter is maintained as long as the legs 1204b-c are in a resting state and not biased by any force. Still referring to Fig. 12B, the projection 1206a may have a larger diameter (at its distal side) that is similar to (or slightly smaller, e.g., 1-10% smaller) the inner diameter of the anchor 1204 at its non-leg region, but thus slightly larger than the inner diameter of the legs 1204b-c in their resting state. Thus, when the push rod 1206 is pushed distally, the distal edge of the projection 1206a engages the proximal edge of the legs 1204b-c, causing the entire anchor 1204 to move distally. Conversely, when the push rod 1206 is pulled back proximally through the anchor 1204, the smaller diameter proximal to the projection 1206a may slide through the non-leg region of the anchor 1204 and expand and bias the legs 1204b-c outwardly when it reaches them until the projection has completely passed through them and positioned itself directly behind the anchor (i.e., directly behind the proximal end of the legs). Then, when the outward bias of the legs 1204b-c ceases, they return to their resting state, ready for another pushing operation.

[0163] Optionally, the legs 1204b-c are configured to expand slightly outward when not biased by any force (e.g., by heat training). This can help prevent the anchor 1204 from sliding back through the tissue orifice when a push rod (discussed below) with the anchor mounted thereon is pulled back from the tissue by expanding the profile of the proximal end of the anchor to be much larger than the tissue orifice.

[0164] The legs 1204b-c may also be configured to have sufficient space therebetween to allow a wire (having a series of anchors therethrough) to pass easily through the space.

[0165] Reference Figures 13C-13D , which show another configuration of anchor 1205 in perspective and side views, respectively. Anchor 1205 can be similar to anchor 1204, except for the following differences: First, anchor 1205 can have fins at its underside, as described above. Second, the entire upper wall of anchor 1205 can be open, except for the loop at the end of the flexible extension; this can allow the wire to pass more freely through the anchor when the anchor is within its packaging sleeve or other tube.

[0166] Fig.14A and 14B A general push operation using the ratchet mechanism of the sleeve arrangement 1200 is illustrated. Fig.14AThe distal-most anchor 1204 is shown positioned in its designated area within the sleeve 1202 prior to being pushed. Pushrod 1206 is then pushed distally and projection 1206a engages anchor 1204 and causes it to also move distally. As anchor 1204 emerges from sleeve 1202 (and optionally, from any other packaging not shown here, such as a shaft, needle, or endoscope channel), its extension 1204a may become unbiased and upright. Next, pushrod 1206 may be pulled proximally, causing projection 1206a to pass through the next anchor in line within sleeve 1202; this anchor may then be positioned distally. Fig. 14B 1202c of the sleeve. Then, when the push rod 1206 is directly behind the anchor, another push operation can be performed, and so on, until all anchors in the sleeve arrangement 1200 are deployed.

[0167] It can be noted that Fig. 12A -14C does not illustrate any grasping device or needle, as these elements may be the same as described above with reference to other embodiments. For example, sleeve arrangement 1200 may be disposed within such a needle and / or grasper that acts to pierce and grasp tissue as described above. Optionally, Fig. 12A The embodiment shown in -14C may not require a needle around the anchor, and may instead rely on an optional sharp tip 1206a of the push rod 1206 to penetrate tissue, and also optionally rely on a distal edge 1204d of the anchor 1204, which is optionally sharp and chamfered, and thus can further expand the initial puncture made by the sharp tip of the push rod. The sharp tip 1206a of the push rod 1206 can be a solid spike, as shown (which punctures the tissue and then widens the initial orifice as it is pushed further into the tissue), or a hypodermic needle (which actually cuts the tissue to a shape that approximates the outer diameter of the needle).

[0168] Reference Figures 15A-15C , which shows that Fig. 12A -14C and its internal components in conjunction with the sleeve arrangement 1200. The shaft arrangement 1500 may be used in place of the shaft referenced 104 or 104a in the previous figures. Fig.15A is an external view of the outer shaft 1502 of the shaft arrangement 1500, Fig. 15B is a cross-sectional view of the shaft arrangement, and Fig. 15C is an external view of the inner tube.

[0169] The shaft arrangement 1500 may include an outer shaft 1502, which is similar to the shaft 104, in that it may be a flexible elongated tube, made of, for example, plastic and / or braided metal, and configured to be flexibly manipulated within an endoscope. The shaft arrangement 1500 may further include an inner tube 1508, as discussed further below.

[0170] The length of the outer shaft 1502 can be, for example, 200-3000 mm, wherein a portion of the length (e.g., between 10-300 mm) can be disposed within a handle, which can be similar to the handle 102 discussed with reference to the previous figure. 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.

[0171] The 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 rigid plastic. The inner diameter of the distal tube 1504 can be slightly larger than the outer diameter of the distal region of the outer shaft 1502, so that the distal tube can surround the distal region of the outer shaft-where it is fixed to each other. The distal tube 1504 can have a perforated wall 1504a at its proximal side, so that if an adhesive is used for fixing, 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 and provides additional resistance to the separation of the distal tube and the outer shaft.

[0172] The distal tube 1504 may be intended to surround a grasping device, which may be configured similarly to that discussed with reference to the previous figures or as described above. Figures 15E-15F The gripping device shown is discussed further below.

[0173] Fig.15D Shows Fig. 12A Sleeve Arrangement 1200 Joint Figures 15A-15C A cross-sectional view of the shaft arrangement 1500 without the anchor member mounted on the push rod 1206 (for greater clarity).

[0174] Figures 15E-15F The exemplary grasper 1506 shown in the figure can be made of the same material as the grasping device described above, and includes a tubular base 1506a and a plurality of concentric tines 1506b (e.g., 3-8 tines, or 5 tines as shown) extending distally from the base. The tines 1506b can be at rest in Fig.15A When the distal tube 1504 is positioned in the gripper 1506 and restrained by the gripper 1506, the gripper 1506 acquires an overall tubular shape consisting of the tines and the base, such as Fig.15E When the tine 1506b moves distally away from the distal tube 1504 and is no longer biased thereby, it assumes its expanded, unbiased posture, as shown in FIG. Fig.15F shown.

[0175] The mechanism of action of the grabber 1506 may be similar to some of the aforementioned grabbing devices: when the grabber 1506 is pushed outside the distal tube 1504, the tines begin to penetrate the tissue in front of the distal tube and move mainly laterally inside the tissue as they continue to expand outward. In this way, ideally, the tines do not even leave the tissue to its distal side, but instead remain completely inside the tissue as they expand, and optionally even leave the tissue back to its proximal side as they curl back and assume a hook shape. This helps prevent damage to other tissue (organs, blood vessels, etc.) located on the other side of the tissue. For example, in Figure 15G In the illustrated (not to scale) surgical procedure performed in the stomach, tines 1506b may fully penetrate the three inner layers of the stomach wall (mucosa, submucosa, and muscularis) and only partially penetrate (or not penetrate at all) the outermost layer of the stomach, the serosa. It is also possible that the tines do not even reach the serosa, but rather fully penetrate the mucosa and submucosa and partially penetrate the muscularis externa. Even in the event that one or more of the tines happen to fully penetrate the tissue (i.e., beyond the serosa), this can only occur if the tines have been curled sideways or even backwards, so damage to other nearby tissue (e.g., nearby organs, blood vessels, etc.) is unlikely.

[0176] Each tine 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 of 5-15 mm (e.g., 7.40 mm) from its distal end to the beginning of the base 1506a. It may be noted that the distal end of each tine 1506b may be blunt and shaped as a triangle with slightly rounded edges (the diameter of the rounded edges being, for example, 0.10-0.30 mm). Each tine 1506b may gradually increase in width as it approaches the base 1506a to strengthen the tine in this transition region. Optionally, each tine may be rectangular along its entire length (currently shown). The base 1506a and tines 1506a may have an overall diameter of 2.0-3.0 mm (eg, 2.48 mm) when collapsed, and the tines may have an overall diameter of 2.50-3.50 mm (eg, 3.00 mm) when fully expanded to their hook shape.

[0177] The wall thickness of the tines 1506b can be selected so that their distal ends are not too sharp and, therefore, will not damage other tissue located behind the tissue being grasped - even if one or more of the tines accidentally emerge on the other side of the tissue being grasped. The configuration of the grasper 1506 (its shape, size, thickness, superelasticity, elasticity, resilience, thermal training, etc.) can be such that a force of between 500-1500 grams (or more specifically, 700-1100 grams) is required to pull the grasper back and collapse it back into the distal tube 1504. This means that the force of the grasper 1506 when it is pulled out of the distal tube 1504 is quite large, so that the tines 1506b will remain fixed to the tissue in their hook shape throughout the anchor implantation procedure (discussed further below).

[0178] In addition, Figures 15B-15C FIG. 1 shows an inner tube 1508 secured to the gripper 1506. The inner tube 1508 is disposed Fig.15A Inside the outer shaft 1502. Fig. 12A The sleeve arrangement 1200 is in turn disposed inside an inner tube 1508. The inner tube 1508 may be made of a flexible material configured to be flexibly manipulated inside an endoscope.

[0179] The inner diameter of the base 1506a of the grabber 1506 may be slightly larger than the outer diameter of the distal region of the inner tube 1508 so that the base can wrap around the distal region of the inner tube where they are secured to each other. The base 1506a, at least at its proximal side, may have a perforated wall so that if an adhesive is used for securing, the adhesive not only contacts the outer wall of the inner tube 1508 and the inner wall of the base, but also fills the perforations and provides additional resistance to separation of the grabber 1506 from the inner tube.

[0180] In order to remove the tines 1506b of the grabber 1506 from the distal tube 1504, the inner tube 1508 can be pushed out of the handle (not shown in this figure) relative to the distal tube 1504.

[0181] Reference Figures 15H-15M , which shows six alternative configurations of grippers that differ from gripper 1506 in the number and shape of tines. Figures 15H-15K The configuration may be adapted to penetrate the full thickness of tissue, while Figure 15L-15M The configuration may be adapted to penetrate only the layers below the serosa and optionally also a partial thickness of the serosa. Figure 15L The configuration is unique in that it provides a two-step grasping of tissue: first, all of the tines penetrate the tissue; as the grasper continues to be pushed toward the tissue, the longer tines curl back and away from the tissue proximally, each curling upon itself almost 360 degrees (or more), enhancing tissue fixation.

[0182] The outer shaft 1502 and the inner tube 1508 may have complementary structures that prevent the prongs 1506b from being pulled too far distally - in which case the prongs 1506b may damage and / or tangle the sleeve arrangement 1200, particularly the flexible and delicate sleeve 1202. These complementary structures may be steps 1502a on the inner wall of the outer shaft 1502 and opposing steps 1508a on the outer wall of the inner tube 1508, so that the outer shaft cannot be pulled too far proximally. Alternative complementary structures are also possible (but not shown), such as reverse-shaped steps or any other structure that physically prevents the relative movement of the outer shaft and the inner tube beyond a certain range.

[0183] By reference Figures 16A-16D , the overall interaction of the shaft arrangement 1500, sleeve arrangement 1200, inner tube 1508 and all of their associated components can be better understood. These figures illustrate four stages of implanting the anchor 1204 beyond tissue 1600.

[0184] exist Fig.16A 16, the entire shaft arrangement 1500 and all of its internal components are adjacent to or in contact with the inner wall of tissue 1600. The shaft arrangement 1500 can be disposed, for example, within a working channel of an endoscope (not shown), such as a gastroscope or colonoscope, with only a distal portion (e.g., the most distal 5-30 mm) of the shaft arrangement exposed outside the distal end of the endoscope.

[0185] exist Fig. 16B , the inner tube 1508 is pushed distally so that the tines 1506b penetrate the tissue 1600 (ideally, not through its entire thickness) and securely grasp it.

[0186] Then, in Fig. 16C In the embodiment of the present invention, the inner tube 1508 (together with the outer shaft 1502) is pulled proximally, pulling the captured tissue 1600 with it while keeping the sleeve arrangement 1200 in place. This creates a pocket-like structure in the tissue 1600 and simultaneously causes the sharp tip of the push rod 1602 to penetrate the full thickness of the tissue and enter the pocket. The distal-most anchor 1204 moves with the push rod 1602 and is also transferred to the other side of the tissue 1600.

[0187] Next, in Fig.16D15, the push rod 1602 is pulled back proximally into the inner tube 1508 and through the anchor 1204, while the proximal end of the anchor is stopped by the rim of the orifice in the tissue and prevented from moving back through the tissue. The anchor 1204 is thus released from the push rod 1602 and remains in a pocket distal to the tissue 1600. Optionally, the base 1506a of the grabber 1506 is configured with a one-way projection (not shown) on its inner surface so that it assists in stripping the anchor 1204 from the push rod 1602 as the push rod is pulled back through the tissue orifice. This further helps prevent the anchor 1204 from remaining on the push rod 1602 as the push rod is pulled back.

[0188] The grasper 1506 may then be released from the tissue 1600 by pulling it back into the distal tube 1504 and prepared for the next anchor implantation sequence.

[0189] Figures 16A-16D The techniques exemplified in and described above—wherein a tissue pocket is created, the tissue is pierced, and an anchor is implanted on the other side of the tissue—can also be facilitated by other embodiments of devices, graspers, and anchors by operating according to similar principles.

[0190] Reference Fig.17A , which is a form of gripper 1506 having six (instead of five) tines (e.g. Figures 18A-18B 1806). The photo was taken after the tines of the grasper had been fully expanded and the grasper was pulled proximally to form a tissue sleeve / pocket, and clearly shows that the tines passed through the stomach wall but did not fully penetrate the serosa.

[0191] Additional references Fig. 17B , which was taken during another pig experiment, this time using a five-pronged gripper (e.g. Figures 15E-15F The photograph shows the sleeve / pocket formed by the stomach wall as the grasper is pulled proximally, and that two of the tines of the grasper have actually fully penetrated the stomach wall and are extending laterally; this suggests that even in the event that one or more of the tines happened to penetrate the full thickness of the tissue, their lateral orientation in doing so (and their potential further posterior curling) would likely prevent damage to organs on the other side of the penetrated tissue.

[0192] Reference Figures 18A-18B , which respectively show a perspective view and a cross-sectional view of a distal region of a shaft arrangement 1800, which can serve as an alternative to the shaft 104 / 104a, shaft arrangement 1500 and / or sleeve arrangement 1200 described above. More specifically, Figures 18A-18B The components can be used with Figures 12A-15G16A-16D and discussed above, and differs primarily in that Figures 18A-18B Embodiments of do not include a flexible sleeve 1202 that houses a series of anchors; instead, it can be configured to house a single anchor at any given time. In addition, Figures 18A-18B Elements in the drawings, if they have the same name, are intended to be similar to elements in the previous figures, except for specific differences that become apparent from the following discussion; this applies to the functionality (method of operation) of such corresponding elements.

[0193] From inside to outside, the shaft arrangement 1800 may include some or all of the following: a needle 1808; an anchor 1812 configured to be mounted on the needle; an anchor backing member 1803 mounted on the needle and behind the anchor; an inner tube 1805 mounted on the anchor backing member; a grabber 1806 attached to, connected to, or formed integrally with the inner tube; an outer shaft 1802 mounted on the inner tube; a distal tube (also called a "grabber collector") 1804, a proximal region of which is fixedly mounted on the outer shaft and a distal region of which is configured to cover the grabber and the inner tube; and a stop ring 1804a, which is attached to, connected to, or formed integrally with the inner wall of the grabber collector, adjacent to the distal end of the inner tube (for example, if the stop ring and the grabber collector are both metal, they can be welded together).

[0194] and Figures 16A-16D Similar to that shown in FIG. 1 , shaft arrangement 1800 can be used to implant multiple anchors beyond tissue, wherein the suture ( Figures 18A-18B The anchors are interconnected similarly to the above description (not shown in the figure to prevent obstruction of view). In operation, a length of approximately 6 to 10 mm of the distal region of the shaft arrangement 1800 may be exposed outside the distal end of the endoscope (i.e., beyond the distal opening of the endoscope working channel) prior to actuating the various components of the shaft arrangement; at this stage, these various components may still be covered by the outer shaft 1802 and / or the grabber collector 1803 so that they cannot damage any tissue.

[0195] Figures 19A-19C 20A-20C show the grabber 1806 in more detail, in a closed (biased) configuration and an open (expanded) configuration, respectively. The grabber 1806 may be similar to Figures 15E-15F The grabber 1506 comprises a tubular base 1806a and a plurality of concentric tines 1806b, such as six tines as shown (but optionally any of 3 to 8 tines).

[0196] The gripper 1806 may be made from a sheet of planar material, such as Fig. 22As shown, for example by laser cutting. The sheet can be rolled to form the tubular shape of the grabber 1806. The sheet can be secured in its tubular shape, for example by using an adhesive between the tubular base 1806a and the inner tube 1805. An optional series of holes 1806c in the tubular base 1806a can strengthen the interconnection between the tubular base and the inner tube 1805 - by allowing some of the adhesive to enter the holes and dry or cure therein, thereby further preventing the grabber 1806 from detaching from the inner tube and rolling freely on the inner tube. Figures 19A-19C In the examples of 20A-20C, the gripper 1806 includes 18 such holes 1806c arranged in 6 concentric groups, each concentric group including 3 longitudinally arranged holes. The area occupied by the holes 1806c can be equivalent to between 10-70% of the total circumferential area of ​​the tubular base 1806a, or more specifically, 10-30%, 20-40%, 30-50%, 40-60% or 50-70%.

[0197] The grabber 1806 may terminate proximally with a chamfer 1806d to smooth the collection of the grabber in the grabber collector 1804 (or outer shaft 1802 in the absence of a grabber collector) by preventing or minimizing collision of the grabber proximal end with the grabber collector (or outer shaft) distal end.

[0198] Grasper 1806 optionally has the following dimensions—advantageously allowing it to fit within a relatively narrow working channel of an endoscope while still successfully fulfilling its tissue grasping function: Overall length (L) of grasper 1806 T +L B ) can be 10 to 20 mm (or optionally more than that), such as 10-13 mm, 12-16 mm, 14-17 mm, 16-19 mm, or 18-20 mm. The length (L) of the tubular base 1806a B ) can be 3-8 mm (or optionally more than that), such as 3-5 mm, 4-6 mm, 5-7 mm or 6-8 mm. The length (L) of the tine 1806b T ) can be 5-13 mm (or optionally more), such as 5-7 mm, 7-9 mm, 9-11 mm, or 10-13 mm. The grabber 1806 can have an outer diameter of approximately 1.5-4.5 mm (or optionally more), such as 1.5-2.5 mm, 2-3 mm, 2.5-3.5 mm, 3-4 mm, or 3.5-4.5 mm.

[0199] The inner tube 1805 may be made of, for example, PEEK, stainless steel, or a similar material.

[0200] refer to Fig.21A, i.e., a top view of a distal region of one of the tines 1806b, each tine, at least at its distal end, may have a width (W) of 0.3 to 1.5 mm (or optionally more), such as 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, 0.8-1.0 mm, 0.9-1.1 mm, 1.0-1.2 mm, 1.1-1.3 mm, 1.2-1.4 mm, or 1.3-1.5 mm. The distal end of the tine may be perpendicular to the longitudinal axis of the grasper 1806 and may be blunt, i.e., it may have rounded corners to subtly facilitate tissue penetration and reduce the likelihood that the tine will fully penetrate the tissue to the other side. The radius (R1) of each rounded corner can be 0.05 to 0.75 mm (or optionally more than it), such as 0.05-0.20 mm, 0.15-0.30 mm, 0.25-0.40 mm, 0.35-0.50 mm, 0.45-0.60 mm, 0.55-0.70 mm, or 0.65-0.75 mm. Each prong 1806b can have a uniform width along most of its length (such as about the distal 80% of its length), such as Figures 19A-19C Optionally, the tines may taper toward their distal ends, each tine having an elongated trapezoidal shape.

[0201] refer to Fig.21B , i.e., a side view of the same distal region of one of the tines 1806b, each tine, at least at its distal end, may have a thickness (D) of 0.1 to 0.85 mm (or optionally more), such as 0.10-0.25 mm, 0.20-0.35 mm, 0.30-0.45 mm, 0.40-0.55 mm, 0.50-0.65 mm, 0.60-0.75 mm, or 0.70-0.85 mm. This may also be the thickness of the sheet of material from which the gripper 1806 is made, such as Fig. 22 shown.

[0202] The tines 1806a (or their associated portions) may be trained (e.g., using heat treatments known in the art) so that they present a positive position when not biased by the grabber collector 1804 (or outer tube if a grabber collector is not used). Figures 20A-20C Shape shown. Reference Fig. 21C, i.e., a side view (profile view) of one of the tines 1806b in an expanded (unbiased) state, each tine can be curled back at an angle of about 180 degrees, as shown, or more generally between 145 and 205 degrees, such as 145-160 degrees, 155-170 degrees, 165-180 degrees, 175-190 degrees, 185-200 degrees, or 195-205 degrees. The inner radius of curvature (R2) of the curled region of the tine can be 1 to 5 mm (or optionally greater), such as 1.0-2.0 mm, 1.5-2.5 mm, 2.0-3.0 mm, 2.5-3.5 mm, 3.0-4.0 mm, 3.5-4.5 mm, or 4.0-5.0 mm. Optionally, the tines may have a straight (uncurled) distal-most region (A), distal to the curled region, having a length of approximately 0.5 to 5.0 mm (or optionally greater), such as 0.5-2.0 mm, 1.5-3.0 mm, 2.5-4.0 mm or 3.5-5.0 mm.

[0203] Refer to Figures 19A-19C 20A-20C, the chamfer 1806d may have an angle of 10-45 degrees (or more) relative to the longitudinal axis of the gripper 1806, such as 10-25 degrees, 20-35 degrees, or 30-45 degrees. The length occupied by the chamfer 1806d may be the length (L) of the tubular base 1806a. B ) is 0.3-1.4mm (or optionally exceeds it), such as 0.3-0.6mm, 0.5-0.8mm, 0.7-1.0mm, 0.9-1.2mm, or 1.1-1.4mm.

[0204] When expanded (without bias), the grasper 1806 can be configured to apply a grasping force of about 0.5 to 2.0 kilograms (kg) to the tissue, such as 0.5-0.8 kg, 0.7-1.0 kg, 0.9-1.2 kg, 1.1-1.4 kg, 1.3-1.6 kg, 1.5-1.8 kg, or 1.7-2.0 kg. This grasping force capability can be a result of the material from which the tines 1806a are made, their training, and their measurements.

[0205] Reference Fig.23A, which shows a side view of the distal region of needle 1808. In general, needle 1808 can be solid (not hollow) and made of a superelastic material (such as Nitinol) or an elastic material (such as stainless steel, CoCr, etc.). The length of needle 1808 can be similar to the length of outer shaft 1802, so that it extends the entire length of the handle. The diameter of needle 1808 can be 0.4 to 1.5 mm (or optionally more than it), for example 0.4-0.7 mm, 0.5-0.8 mm, 0.6-0.9 mm, 0.7-1.0 mm, 0.8-1.1 mm, 0.9-1.2 mm, 1.0-1.3 mm, 1.1-1.4 mm or 1.2-1.5 mm, except for specific grooves, as further discussed below.

[0206] Needle 1808 may have a sharp tip, such as a multi-beveled spear. Fig. 23B Such a sharp tip is illustrated from the front, where three exemplary bevels 1808c are shown. Each bevel 1808c can have an angle (α) of 8-30 degrees (or optionally more than) relative to the longitudinal axis of the needle 1808, such as 8-12 degrees, 10-14 degrees, 12-16 degrees, 14-18 degrees, 16-20 degrees, 18-22 degrees, 20-24 degrees, 22-26 degrees, 24-28 degrees, or 26-30 degrees.

[0207] Needle 1808 may include a groove 1808a in its distal region, such as Fig.23C 1808a. The groove 1808a can be configured to receive the inward lug of the anchor, as will be discussed in more detail below, so that the anchor remains fixed to the needle 1808 as the needle penetrates the tissue. The length (L2) of the groove 1808a can be 1-3 mm (or optionally more than it), such as 1-2 mm, 1.5-2.5 mm or 2-3 mm. The diameter of the groove 1808a at its thinnest area can be approximately 50-80% of the diameter of the needle 1808 as described above. At its distal end, the groove 1808a can include an inclined surface 1808b, which is set at an angle of 15-45 degrees (or optionally more than it) relative to the longitudinal axis of the needle, such as 15-25 degrees, 20-30 degrees, 25-35 degrees, 30-40 degrees or 35-45 degrees. Optionally, there may be a concave surface (R1) between the inclined surface 1808b and the thinnest area of ​​the groove 1808a, so that the leading edge of the inward lug of the anchor can slide more easily outside the groove; the concave surface (R1) may have a radius of curvature of, for example, 0.02 to 0.10 mm. At its proximal side, the groove 1808a may include another concave surface (R2) having a radius of curvature of, for example, 0.02 to 0.30 mm. In general, the diameter of the groove 1808a may gradually decrease from the maximum diameter of the needle 1808 to the thinnest area of ​​the groove.

[0208] The distal region of needle 1808 - from the distal end of the needle to the start of groove 1808a - can have a length (L1) of 1-10 mm (or optionally more than that), such as 1-3 mm, 2-4 mm, 3-5 mm, 4-6 mm, 5-7 mm, 6-8 mm, 7-9 mm or 8-10 mm.

[0209] Reference Figures 25A-25D , which shows four vertical side views of the anchor 1812 when the anchor is in a closed (biased) configuration. Figures 26A-26C , which shows a first perspective view, a side view, and a second perspective view of the anchor 1812 when the anchor is in an open (expanded, unbiased) configuration.

[0210] The anchor 1812 can have a generally tubular body, optionally cut (e.g., laser cut) from a tube of material or cut (e.g., laser cut) from a sheet of material and rolled; the material can be superelastic (e.g., Nitinol) or elastic (and optionally resilient) such as stainless steel, CoCr, PEEK, etc. The wall thickness of the tubular body can be about 0.1 to 0.4 mm (or optionally more), such as 0.1-0.2 mm, 0.15-0.25 mm, 0.2-0.3 mm, 0.25-0.35 mm, or 0.3-0.4 mm. The length of the tubular body can be about 4 to 16 mm (or optionally more), such as 4-7 mm, 6-9 mm, 8-11 mm, 10-13 mm, or 12-16 mm. The outer diameter of the tubular body may be approximately 0.5 to 2 mm (or optionally greater), such as 0.5-0.8 mm, 0.7-1.0 mm, 0.9-1.2 mm, 1.1-1.4 mm, 1.3-1.6 mm, 1.5-1.8 mm, or 1.7-2.0 mm.

[0211] The anchor 1812 can include an extension 1812a that is essentially a shaped cutout of its sidewall and is trained (e.g., in the case of nitinol, using a suitable heat treatment) to stand at an angle of about 45 to 135 degrees (or optionally exceeding it) relative to the longitudinal axis of the anchor, such as 45-60 degrees, 55-70 degrees, 65-80 degrees, 75-90 degrees, 85-100 degrees, 95-110 degrees, 105-120 degrees, 115-130 degrees, or 125-135 degrees. Optionally, with the expansion of the extension 1812a, the anchor 1812 has a substantially T-shape. The length of the extension 1812a can be between 2 and 8 mm (or optionally exceeding it), such as between 2-3 mm, 3-4 mm, 4-5 mm, 5-6 mm, 6-7 mm, or 7-8 mm. The width of the extension 1812a may be 0.5-2 mm (or optionally more than that), such as 0.5-0.8 mm, 0.7-1.0 mm, 0.9-1.2 mm, 1.1-1.4 mm, 1.3-1.6 mm, 1.5-1.8 mm or 1.7-2.0 mm. Fig.18B ), the extension 1812a can be offset to approximately the same tubular circumference of the entire anchor 1812. The ratio of the length of the tubular body of the anchor 1812 and the extension 1812a can be, for example, between 1:0.3 and 1:0.7, or more specifically 1:0.3-1:05, 1:0.4-1:0.6, or 1:0.5-1:0.7.

[0212] Extension 1812a may include a hole (also referred to as a "loop" or "annular ring") 1812b to allow passage of a suture (not shown here), similar to the anchor described above. The inner edge of hole 1812b may be treated, such as by electropolishing, to make it very smooth (e.g., up to 10 or 20 microns of surface roughness) so that it does not damage the suture during tensioning. Additionally or alternatively, the inner edge may be coated with a smooth material, optionally a polymer.

[0213] The anchor 1812 may also include an inward lug 1812e cut from its sidewall and trained (eg, using a suitable heat treatment) to protrude approximately 0.1-1.3 mm into the void of the tubular body of the anchor. The inward lug 1812e may be disposed opposite the extension 1812a.

[0214] An alternative anchor (not shown) may be similar to anchor 1812, but without the extension. Instead, the suture may be passed through a pair of holes in the side wall of the anchor around its middle, or through any other suitable structure that does not protrude significantly from the side wall of the anchor.

[0215] Refer to Fig.18B, it can be seen how the inward lug fits into the groove in the needle 1808 so that the anchor 1812 cannot slide distally and disengage from the needle unless sufficient force is applied, such as 0.1 to 1 kg (or optionally more than that), or more specifically 0.1-0.3 kg, 0.2-0.4 kg, 0.3-0.5 kg, 0.4-0.6 kg, 0.5-0.7 kg, 0.6-0.8 kg, 0.7-0.9 kg, or 0.8-1.0 kg. The force can be applied by withdrawing the needle 1808 proximally while holding the anchor backing member 1803 stationary so that the anchor 1812 slides distally on the needle and disengages from the needle.

[0216] Back to Figures 25A-25D 26A-26C, the anchor 1812 optionally has a bevel 1812c and / or chamfer 1812d at its distal end to minimize resistance from the tissue when the tissue is pierced by the needle 1808 and then expanded by the anchor passing through the piercing site. The bevel 1812c and / or chamfer 1812d can each be at an angle of 10 to 50 degrees relative to the longitudinal axis of the anchor 1812, such as 10-20 degrees, 15-25 degrees, 20-30 degrees, 25-35 degrees, 30-40 degrees, 35-45 degrees, or 40-50 degrees.

[0217] refer to Fig. 27 , alternative anchor 1813 may be identical to anchor 1812, except that it may not have a bevel at its distal end.

[0218] Refer to Figures 18A-18B , the anchor 1812 can be supported from behind by the anchor backing member 1803, which is a tube that optionally extends up to the handle. The anchor backing member 1803 can be made of one of the above-mentioned elastic materials or superelastic materials or similar materials. The outer diameter of the anchor backing member 1803 can be greater than the inner diameter of the anchor 1812, thereby preventing the anchor from sliding backward when the anchor backing member remains stationary. In this way, when the needle 1808 is withdrawn proximally, the anchor 1812 is forced to slide forward on the needle and eventually released from the needle.

[0219] Refer to Figures 18A-18B , the grabber collector 1804 can be a tube made of stainless steel, Co-Cr, etc., and is fixedly mounted on the outer shaft 1802, for example using an adhesive or by melting a polymer (e.g., PEEK) outer shaft to the grabber collector. The grabber collector 1804 can have a series of optional holes 1804b at its proximal side 1-10 mm (or optionally beyond it) to strengthen the interconnection between the grabber collector and the outer shaft 1802 - by allowing some adhesive to enter the holes and dry or cure therein; this can further prevent the grabber collector from detaching from the outer shaft and rolling freely on the outer shaft.

[0220] The grabber collector 1804 may further include one or more elongated slits 1804c, which are arranged at an angle of 30-80 degrees relative to the longitudinal axis of the grabber collector and located within the middle third of its length to impart a certain axial flexibility to the grabber collector; that is, when the grabber collector is in the working channel of the endoscope and the endoscope is hinged at an acute angle, the flexibility of the grabber collector can prevent it from getting stuck in the working channel.

[0221] The grab collector 1804 may further include the stop ring 1804a briefly mentioned above. The stop ring 1804a may be made of one of the materials mentioned above with respect to the grab collector 1804, and may be configured to prevent the grabber 1806 from accidentally sliding into the outer tube 1802 as the grabber is withdrawn rearwardly; this may occur if the outer tube is a polymer (e.g., made of PEEK) and the superior rigidity of the grabber moving rearwardly causes it to forcibly expand the inner diameter of the polymer outer tube and become stuck therein. The stop ring 1804a, which is at least as rigid as the grabber 1806, may prevent this from occurring.

[0222] Regarding the outer shaft 1802, its purpose may be to encapsulate more internal components of the shaft arrangement 1800. The outer shaft 1802 may have an outer diameter that allows it to fit in the working channel of an endoscope, such as up to an outer diameter of 3 mm (or in other embodiments, a larger outer diameter). The outer shaft 1802 may be made of materials such as stainless steel, PEEK, etc. To increase its flexibility and ability to articulate within a flexible endoscope, the outer shaft may optionally be configured as a coil or mesh.

[0223] Device for implanting an anchor beyond tissue to suture tissue (including Figures 18A-18B The device of the shaft arrangement 1800) can generally operate as follows (similar to the above reference Figures 16A-16D as described above, except for certain differences that will become apparent from the following discussion):

[0224] The distal region of the shaft arrangement 1800, with all its internal components, is adjacent to or in contact with the inner wall of the tissue. The shaft arrangement 1800 can be disposed, for example, within a working channel of an endoscope (not shown), such as a gastroscope or colonoscope, with only the distal portion of the shaft arrangement (e.g., its most distal 5-30 mm) exposed outside the distal end of the working channel.

[0225] The inner tube 1805 is pushed distally and moves with its attached grasper 1806 so that the tines 1806b penetrate the tissue and firmly grasp the tissue as they curl back. As described above, penetration can be penetration into a partial thickness or full thickness of the tissue.

[0226] Then, the inner tube 1805 with the grabber 1806 (and with the outer shaft 1802 and grabber collector 1804) is pulled proximally, pulling the grasped tissue therewith while keeping the needle 1808, anchor 1812, and anchor backing member 1803 stationary in place. This creates the aforementioned pocket in the tissue and simultaneously causes the sharp tip of the needle 1808 and subsequently the anchor 1812 to penetrate the full thickness of the tissue, leaving the anchor completely within the pocket.

[0227] Next, the needle 1808 is withdrawn proximally into the inner tube 1805 while holding the anchor backing member 1803 stationary in place, so that the anchor 1812 slides over the needle. The anchor 1812 is thus released and retained within the distal pocket of tissue.

[0228] The grasper 1806 can then be released from the tissue by pulling it back into the grasper collector 1804 (or directly into the outer shaft 1802 if a grasper collector is not used), or by advancing the grasper collector 1804 (or outer shaft 1802) over the grasper so that the fork teeth 1812b assume their straight-line offset configuration.

[0229] Another anchor may then be loaded into shaft assembly 1800 at a designated location on the groove in needle 1808 and the above procedure repeated.

[0230] After all anchors are implanted, the suture (not shown) can be tensioned to bring all anchors (and the tissue to which they are secured) closer together, and the suture can be secured relative to the last (most proximal) anchor, for example using a manual knot on the anchor, or a tie large enough to prevent the suture from slipping through the loop of the last anchor.

[0231] The operation of this device can be referred to Fig.24 As is better understood, it is a flow chart of a method 2800 of suturing tissue, comprising the following steps:

[0232] Step 2402 may include inserting a flexible endoscope including a working channel having a distal opening through a body orifice (eg, mouth, nose, rectum, or vagina) of a patient.

[0233] Step 2404 may include providing a tubular grabber comprising resilient tines configured to expand outwardly when unbiased.

[0234] Step 2406 may include exposing the tubular grasper from the distal opening of the working channel and unbiasing the tines so that the tines penetrate and secure tissue as they expand outward.

[0235] Step 2408 may include providing a needle disposed within the tubular grasper, and a tubular anchor disposed on and secured to the needle, and wherein the surgical wire is passed through the tubular anchor.

[0236] Step 2410 may include pulling the tubular grasper proximally so that the secured tissue forms a sleeve, the tissue is pierced by the needle, and the tubular anchor passes distally to the tissue while still secured to the needle.

[0237] Step 2412 may include withdrawing the needle proximally and releasing the tubular anchor from the flexible needle within a sleeve formed distally of the tissue.

[0238] Step 2414 may include biasing the tines of the tubular grasper such that the tissue is released from the tines.

[0239] Step 2416 may include loading a new tubular anchor onto the flexible needle and repeating steps 2406, 2410, 2412, and 2414 with respect to the new tubular anchor.

[0240] Step 2418 may include tensioning the surgical thread, thereby forming a suture extending between the tubular anchor and the new tubular anchor.

[0241] Step 2420 may include securing the surgical wire relative to the new tubular anchor such that tension is maintained.

[0242] An important aspect of embodiments of the present invention is the layered, substantially concentric configuration of the elements of the axial arrangement, each element being generally tubular and mounted above, behind or in front of one or more other elements. This enables suturing of tissue through the working channel of the endoscope (by implanting a series of anchors interconnected by sutures) that only allow movement along the longitudinal axis of the working channel; such axial movement of the elements (relative to each other and to the working channel) avoids the need for various "on-tube" type tools that must be mounted on the distal region of the endoscope. This also avoids the need to implement certain miniature, complex and delicate tools (suturing tissue from side to side, i.e., passing sutures in a direction substantially perpendicular to the working channel of the endoscope).

[0243] Another important aspect of embodiments of the present invention is an extension of the anchor that can be biased to confirm the overall tubular shape of the anchor after being in the relevant axial arrangement, and erected to an expanded configuration when the anchor is released. When the extension is expanded, such as when expanded to a perpendicular configuration relative to the longitudinal axis of the tubular body of the anchor, it prevents the anchor from returning to the proximal side of the tissue through the orifice previously created by the needle; that is, the T-shaped structure (the anchor when the extension is expanded) is almost impossible to pass through an orifice with a diameter similar to one of the arms of the T. Optionally, when the suture is tensioned, only the terminal region of the extension (where the loop is set) returns through the orifice in the tissue.

[0244] A further important aspect of embodiments of the present invention is that the gripper (e.g. Figures 15E-15G , 18A-B or other graspers), and in particular the tines thereof, are configured to penetrate the tissue only partially (less than its full thickness) when grasping the tissue, or in less cases penetrate to the distal side of the tissue - but only after the tines have been expanded to an angle exceeding approximately 60°, 70°, 80°, 90°, 100°, 110° or 120° relative to the longitudinal axis of the tubular base of the grasper, so that the distal edges of the tines are less likely to damage any organ that happens to be located distally adjacent to the penetrated tissue.

[0245] The needle may be hollow in some embodiments and solid in other embodiments, whether one or another type of needle is described above with respect to specific embodiments as an example. Figures 18A-18B The needle 1808 in FIG. 1 is shown and discussed as a solid needle, but it may also be configured as a hollow needle.

[0246] In some embodiments, a biocompatible lubricant may be introduced between the surfaces of substantially concentric elements to smooth the sliding of one over the other. For example, a lubricant may be provided between the outer shaft and the inner shaft (on which the gripper is mounted), between the inner shaft and the anchor backing member, between the anchor backing member and the needle, and the like. The lubricant may be introduced between such components during the manufacture of the device and / or during use of the device, by pumping the lubricant through appropriate openings in the handle to disperse it into various cavities. In lieu of or in addition to the lubricant, a biocompatible cleaning fluid may be pumped through one or more cavities in a distal direction during use of the device to push and expel any dirt, such as blood, tissue particles, and the like, that may have entered the distal region of the shaft arrangement.

[0247] In some embodiments, the inner diameter of each tubular element (or 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 element having a tubular portion) disposed therein. Such spacing between overlapping (and optionally, substantially concentric) elements facilitates their relative movement (sliding one over the other), but is also small enough so that the outermost element (such as the aforementioned outer shaft (and / or grabber collector)) has a sufficiently small outer diameter to fit within the working channel of the endoscope.

[0248] The handle in an embodiment of the present invention may include a plurality of actuators, which are physically connected to at least some elements of the shaft arrangement, enabling a user (such as a surgeon) to manipulate these elements from the handle to achieve the various steps of suturing tissue as described above. Optionally, such actuators may be provided without a handle.

[0249] During use of some embodiments of the present invention in a patient's stomach (from an esophageal approach of the endoscope), the tissue (gastric wall) sleeve formed by pulling back the grasper can be substantially cylindrical in shape, rather than (or substantially not) conical, because the abdominal cavity is generally in a vacuum state during the operation. The vacuum pump can also be operated through the endoscope to cause the stomach to collapse on the distal region of the endoscope (and on any part of the shaft arrangement extending outside the distal end of the endoscope), thereby more conveniently facilitating the manipulation of the shaft arrangement to suture tissue, especially using the grasper to grasp tissue.

[0250] The description of various embodiments of the present invention is presented for illustrative purposes and is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations are apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terms used herein are selected to best illustrate the principles of the embodiments, practical applications, or technical improvements over existing technologies in the market, or to enable other persons of ordinary skill in the art to understand the embodiments disclosed herein.

[0251] In the specification and claims, the terms "substantially", "mainly" and their forms, when describing a numerical value, mean a deviation of up to 20% (i.e., ±20%) from the numerical value; similarly, when such terms describe a numerical range, they mean a wider range of up to 20% (10% on each side of the range). In addition, when the terms "substantially", "mainly" and their forms are used to describe geometric terms (such as "vertical", "orthogonal", "parallel", "plane", "coplanar", "coaxial", "horizontal", "vertical", etc.) that define an angle, they mean a deviation of up to 25 degrees (i.e., ±25°) from the angle.

[0252] The description of a numerical range should be considered to have specifically disclosed all possible subranges and individual values ​​within the range. For example, the description of a range from 1 to 6 should be considered to have specifically disclosed subranges within the range such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and individual values, such as 1, 2, 3, 4, 5 and 6. This applies regardless of the width of the range. Similarly, the description of a fractional range of 0.6 to 1.1 should be considered to have specifically disclosed subranges within the range 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 values, such as 0.6, 0.7, 0.8, 0.9, 1 and 1.1.

[0253] In the specification and claims of the present application, each word "includes", "comprising" and "having" and its forms are not necessarily limited to the members in the list to which the word can be associated. In addition, in the event of inconsistency between the present application and any document incorporated by reference, the present application shall prevail.

Claims

1. A device comprising: a tubular grabber comprising resilient tines configured to expand outwardly when unbiased; a needle disposed within the tubular grasper and configured to penetrate tissue; a tubular anchor disposed on the needle; as well as A surgical thread passes through the tubular anchor.

2. The apparatus of claim 1 , further comprising one or more actuators configured to: pushing the tubular grasper distally out of the distal end of the endoscope so that the tines expand outwardly, penetrate tissue, and secure the tissue to the grasper; pulling the tubular grasper proximally such that the tissue secured to the grasper is pulled proximally while the needle and the tubular anchor penetrate the tissue, thereby positioning the anchor distally of the tissue; pulling the flexible needle proximally and releasing the tubular anchor beyond the tissue; as well as The surgical wire is tensioned proximally of the tissue, so that the tubular anchor pulls the tissue proximally.

3. The device of claim 2, wherein the one or more actuators are at least partially contained in a handle.

4. A device according to any preceding claim, wherein the tubular anchor comprises a tubular body and a resilient extension, the resilient extension being configured to expand outwardly from the tubular body when unbiased, and wherein the extension comprises a loop through which the surgical thread is passed.

5. The apparatus according to any one of claims 1, 2 and 4, further comprising: an inner shaft to which the tubular grabber is secured; as well as A flexible tubular outer shaft is configured to surround the inner shaft.

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

7. The apparatus according to any preceding claim, further comprising: A tubular grabber collector is mounted on the outer shaft and is configured to surround the tubular grabber.

8. Apparatus according to any preceding claim, wherein each tine of the tubular grabber has a blunt edge.

9. Apparatus according to any preceding claim, wherein the extension is a cut through the wall of the tubular anchor.

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

7.

11. The device according to any preceding claim, wherein the tubular body of the anchor has a chamfered distal edge to facilitate penetration of the tissue with the needle.

12. The device according to any preceding claim, wherein the tubular body of the anchor has a beveled distal edge to facilitate penetration of the tissue with the needle.

13. A tissue grasper, comprising: a tubular body made of a resilient material and having a plurality of tines configured to expand outwardly when unbiased; a tube configured to surround the tubular body and the tines and to bias the tines so that the tines assume a tubular configuration; as well as An actuator, the actuator being configured to: pushing the tubular body relative to the tube so that the tines exit the tube and penetrate tissue while expanding outwardly to secure the tissue to the tines, and The tubular body is pulled relative to the tube, causing the tines to enter the tube while releasing the tissue.

14. The tissue grasper of claim 13 wherein the resilient material is a superelastic metal alloy and wherein the tines are trained to a normal expanded configuration.

15. The tissue grasper according to any one of claims 13-14, wherein the plurality of tines is 3-8 tines.

16. The tissue grasper according to any one of claims 13-14, wherein the plurality of tines is 4-7 tines.

17. The tissue grasper according to any one of claims 13-14, wherein the plurality of tines is 5-6 tines.

18. The tissue grasper of any one of claims 13-17, wherein each tine has a blunt edge.

19. A method comprising: a) inserting a flexible endoscope through a body orifice of a patient, the flexible endoscope comprising a working channel having a distal opening; b) providing a tubular grasper comprising resilient tines configured to expand outwardly when unbiased; c) exposing the tubular grasper from the distal opening of the working channel and unbiasing the tines so that the tines penetrate and secure tissue when expanded outward; d) providing a needle disposed within the tubular grasper and a tubular anchor disposed on and secured to the needle, and wherein a surgical thread is passed through the tubular anchor; e) pulling the tubular grasper proximally so that the secured tissue forms a sleeve, the tissue is pierced by the needle, and the tubular anchor passes distally to the tissue while still secured to the needle; f) withdrawing the needle proximally and releasing the tubular anchor from the flexible needle within the formed sleeve distal to the tissue; g) biasing the tines of the tubular grasper such that the tissue is released from the tines; h) loading a new tubular anchor onto the flexible needle and repeating steps c, e, f and g with respect to the new tubular anchor; i) tensioning the surgical thread to form a suture extending between the tubular anchor and the new tubular anchor; as well as j) Fixing the surgical thread relative to the new tubular anchor such that tension is maintained.

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

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

22. The method of any one of claims 19-21, wherein the tubular anchor comprises a tubular body and a resilient extension, the resilient extension being configured to expand outwardly from the tubular body when unbiased, and wherein the extension comprises a loop through which the surgical thread is passed.

23. The method according to any one of claims 19, 20 and 22, further comprising: providing an inner shaft to which the tubular grasper is secured; as well as A flexible tubular outer shaft is provided, the outer shaft being configured to surround the inner shaft.

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

25. The method according to any one of claims 19 to 24, further comprising: A tubular grabber collector is provided, mounted on the outer shaft and configured to surround the tubular grabber.

26. The method of any one of claims 19-25, wherein each tine of the tubular grabber has a blunt edge.

27. The method of any one of claims 19-26, wherein the extension is a cut through a wall of the tubular anchor.

28. The method of any one of claims 22-27, wherein the ratio of lengths between the tubular body of the anchor and the extension of the anchor is between 1:0.3 and 1:0.

7.

29. The method of any one of claims 22-28, wherein the tubular body of the anchor has a chamfered distal edge to facilitate penetration of tissue with the needle.

30. The method of any one of claims 22-29, wherein the tubular body of the anchor has a beveled distal edge to facilitate penetration of tissue with the needle.

Images