Device for increasing force distribution at the suture-tissue interface

Abstract

The present invention generally relates to devices, apparatus and methods for increasing force distribution at a suture-tissue interface. In some embodiments, a tissue suturing device may include a deployment device and a plurality of tissue supports that can be deployed from the deployment device toward a target tissue. The plurality of tissue supports may each include a central opening for receiving a suture during deployment.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62 / 860,108, filed on June 11, 2019, the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0003] The present invention relates generally to suturing devices, and more particularly to suturing devices for increasing force distribution at a suture-tissue interface. Background Art

[0004] Suturing is used in a variety of endoscopic procedures, such as closing wounds, anchoring stents or other implants, or shortening the curvature in the stomach. Several types of sutures and devices for implantation and extraction have been developed. In some methods, suturing is performed by repeatedly passing a sharp suture needle attached to a length of suture material through the portions of tissue to be sutured together. The free ends of the suture material are then tied together to complete the suturing procedure.

[0005] Many endoscopic procedures pull tissue together and hold the tissue in a new configuration. However, reconfiguring and constraining the tissue generates tension between the tissue and the suture. While current sutures and suturing methods can provide a sufficiently temporary solution for holding tissue, over time, the force required to hold the tissue in place will become too great to maintain balance. As a result, when the tissue relaxes, the suture may tear the tissue. In view of the above considerations, the improvements of the present invention may be useful. Summary of the invention

[0006] The present invention, in its various embodiments, generally relates to devices, apparatuses, and methods for redistributing forces at the tissue-suture interface to increase the long-term effectiveness of endoscopic suturing procedures.

[0007] In one or more embodiments, a tissue suturing device for use with an endoscope may include a tissue suturing device that can be coupled to the distal end of the endoscope, the tissue suturing device including a plurality of tissue supports, wherein each of the plurality of tissue supports can be deployed toward a target tissue, and wherein one or more of the plurality of tissue supports receive a suture during deployment. In some embodiments, the tissue suturing device may also include a needle, wherein the needle engages one of the plurality of tissue supports to deploy the tissue support. In some embodiments, the tissue suturing device may also include a collar extending from a fixed end of the tissue suturing device, wherein the collar defines a collar opening aligned with a working channel of the endoscope, and wherein each of the plurality of tissue supports extends around the outside of the collar before deployment. In some embodiments, the deployment device may include a housing containing a plurality of tissue supports, and a cover extending across the housing, the cover including an opening to allow access to the plurality of tissue supports by a needle attached to the suture. In some embodiments, the deployment device may include an internal channel and a biasing device for biasing the plurality of tissue supports within the internal channel, wherein the plurality of tissue supports are arranged end-to-end within the internal channel. In some embodiments, the deployment device may include a mandrel defining a central channel, wherein each of the plurality of tissue supports is concentrically arranged around the mandrel. In some embodiments, the suture may include a core and a sheath, wherein the sheath may be operable to radially expand from the core in an area adjacent to the target tissue. In some embodiments, the sheath may include a plurality of flexible strands. In some embodiments, a plurality of tissue supports may include one or more of the following: a flexible gasket, a sprayable adhesive, a wadding, and a spring loaded line.

[0008] In one or more embodiments, the tissue suturing device may include a deployment device and a plurality of tissue supports that can be deployed from the deployment device toward the target tissue. The plurality of tissue supports may each include a central opening for receiving a suture during deployment. In some embodiments, the tissue suturing device may also include a fixed end fixed to the distal end of the endoscope; and a free end opposite to the fixed end, wherein the deployment device is coupled to one of the following: the fixed end and the free end. In some embodiments, the deployment device may include a collar extending from the fixed end, wherein the collar defines a collar opening aligned with the working channel of the endoscope, and wherein each of the plurality of tissue supports extends around the outside of the collar before deployment. In some embodiments, the deployment device may include a housing surrounding the plurality of tissue supports, and a cover extending across the housing, the cover including an opening to allow access to the plurality of tissue supports by a needle attached to the suture. In some embodiments, the housing may include an internal channel and a biasing device for biasing the plurality of tissue supports within the internal channel, wherein the plurality of tissue supports are arranged end-to-end within the internal channel.

[0009] In one or more embodiments, a method may include passing a needle and a suture of a tissue suturing device through a target tissue, the tissue suturing device extending from the distal end of an endoscope. The method may also include deploying a first tissue support from the tissue suturing device to a position along the first portion of the target tissue, and deploying a second tissue support from the tissue suturing device to a position along the second portion of the target tissue, wherein tightening the suture brings the first tissue support and the second tissue support closer together. In some embodiments, the method may also include accommodating a plurality of tissue supports in a deployment device, wherein the first tissue support is exposed in a suturing cavity, engaging the first tissue support in the suturing cavity by a needle to remove the first tissue support from the deployment device, exposing the second tissue support in the suturing cavity, and engaging the second tissue support in the suturing cavity by a needle to remove the second tissue support from the deployment device. In some embodiments, the method may also include entering a plurality of tissue supports through an opening of a cover extending across the deployment device. In some embodiments, the method may also include using a biasing device to bias a plurality of tissue supports toward the suturing cavity. In some embodiments, the method may include removing a first tissue support from a tissue stapling device using a set of prongs, removing the first tissue support from the set of prongs and moving it to a suture line, removing a second tissue support from the tissue stapling device using the set of prongs, and removing the second tissue support from the set of prongs and moving it to the suture line.

[0010] One or more of the various features outlined above may be interchanged, exchanged, combined, or substituted with other features outlined above for use in conjunction with the apparatus, devices, and methods outlined above and in connection with the embodiments described in more detail below and otherwise within the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Non-limiting embodiments of the present invention are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown is generally represented by a single numeral. For clarity, not every component is labeled in every figure, nor is every component of each embodiment shown necessary to allow one skilled in the art to understand the present invention. In addition, some of the figures include cross-sectional views in "slice" form or "close-up" cross-sectional views, omitting certain background lines or otherwise visible features in a "true" cross-sectional view for clarity of illustration. In the drawings:

[0012] Figure 1 is a side view of a tissue stapling device according to an embodiment of the present invention;

[0013] Figure 2 According to an embodiment of the present invention Figure 1A side cross-sectional view of an example deployment arrangement of a tissue stapling device;

[0014] Figure 3A According to an embodiment of the present invention Figure 2 A front view of an exemplary covering over a deployment device;

[0015] Figure 3B According to an embodiment of the present invention Figure 2 A front view of an exemplary covering over a deployment device;

[0016] Figure 4A According to an embodiment of the present invention Figure 1 An end view of an exemplary deployment device for a tissue stapling device;

[0017] Figures 4B to 4E The invention is to illustrate the use of the embodiment according to the present invention Figure 4A A side cross-sectional view of the process of deploying the device;

[0018] Figure 5 is a perspective view of an exemplary deployment device according to an embodiment of the present invention;

[0019] Figure 6 According to an embodiment of the present invention Figure 5 A partial cross-sectional perspective view of a deployment device;

[0020] Figures 7A to 7I The invention is to illustrate the use of the embodiment according to the present invention Figures 5 to 6 A side view of the process of deploying the device;

[0021] Figures 8A to 8D is a perspective view illustrating the use of an exemplary suture according to an embodiment of the present invention;

[0022] Figures 9A to 9D is a perspective view illustrating the use of an exemplary suture according to an embodiment of the present invention;

[0023] Fig. 10A is a side view of an exemplary suture according to an embodiment of the present invention;

[0024] Fig. 10B According to an embodiment of the present invention Fig. 10A A top cross-sectional view of a suture line;

[0025] Fig. 10C is according to an embodiment of the present invention after retracting the suture line Fig. 10A Side view of the suture line;

[0026] Fig.11A is a top cross-sectional view of an example suture according to an embodiment of the present invention;

[0027] Fig. 11B is according to an embodiment of the present invention after retracting the suture line Fig.11A Side view of the suture line;

[0028] Figures 12A to 12B is a perspective view illustrating the use of a sprayable adhesive applied to a tissue area according to an embodiment of the present invention;

[0029] Figures 13A to 13C is a perspective view illustrating the use of glue applied to a tissue area according to an embodiment of the present invention;

[0030] Fig.14A is a perspective view illustrating the use of a tubular tissue support according to an embodiment of the present invention;

[0031] Fig. 14B is a perspective view illustrating an example tubular tissue support according to an embodiment of the present invention;

[0032] Fig. 14C is a perspective view illustrating another exemplary tubular tissue support according to an embodiment of the present invention;

[0033] Fig.15 is a perspective view of the use of a spring loaded wire according to an embodiment of the present invention; and

[0034] Fig.16 is a flow chart of a method according to an embodiment of the present invention. DETAILED DESCRIPTION

[0035] The present invention is not limited to the specific embodiments described herein. The terms used herein are only used to describe specific embodiments and are not intended to be limited beyond the scope of the appended claims. Unless otherwise specified, all technical terms used herein have the same meaning as those generally understood by ordinary technicians in the field to which the present invention belongs.

[0036] Embodiments herein disclose endoscopic tissue suturing devices, apparatus and methods for increasing the force distribution at the suture-tissue interface. It will be appreciated by those skilled in the art that, although the method of the present invention will be described herein with reference to suturing the region of the stomach, the method may also be used in other gastrointestinal endoluminal surgeries and may be introduced perorally as well as per anally.

[0037] Although not limiting, the methods of the present invention may be effective in treating gastroesophageal reflux disease (GERD) by performing a procedure such as a circumferential endoscopic mucosal resection (EMR) or submucosal dissection (ESD) of a portion of a patient's gastrointestinal tract.

[0038] Now turn to Figure 1, a tissue stapling device (hereinafter referred to as "device") 100 according to an embodiment of the present invention will be described. As shown, the device 100 may include a tissue stapling device (hereinafter referred to as "device") 110 extending from a distal end 112 of a scope, such as an endoscope 114. The device 110 may also be used with other types of scopes, such as bronchoscopes, duodenoscopes, gastroscopes, colonoscopes, etc. The device 110 may include a head or cap 115 directly connected to the endoscope 114, and a free end 118 opposite to the fixed end 116. In some embodiments, the cap 115 can be connected to the endoscope 114 using a variety of techniques, such as by mechanical fasteners, glue, suturing, press fit, tape, overmolding, etc. In other embodiments, the dispenser cap can be formed integrally with the endoscope.

[0039] During use, the needle 120 can be passed back and forth between the fixed end 116 and the free end 118 along the longitudinal axis, and the needle 120 includes one or more sharp tips for piercing the target tissue 122 at each pass. In some embodiments, the tissue grasper 124 can be delivered through the channel 126 of the cap 115 to engage the target tissue 122, thereby bringing the target tissue 122 into the suture cavity 130 located between the fixed end 116 and the free end 118.

[0040] The device 110 may include a deployment device 135 including a plurality of tissue supports (not shown). As will be explained in more detail below, the tissue supports may be added between the suture and the target tissue 122 during one or more passes of the needle 120. In some embodiments, the deployment device 135 may be coupled to the free end 118 of the device 110, which is generally located opposite the fixed end 116.

[0041] Now turn to Figure 2, the tissue deployment device 235 according to an embodiment of the present invention will be described. As shown, the deployment device 235 can be a cylindrical object including a housing 238, in which a plurality of tissue supports are included. The housing 238 can include an internal channel 242 and a biasing device 244 (e.g., a spring) for biasing a plurality of tissue supports 240 through the internal channel 242. In some embodiments, a plurality of tissue supports 240 are solid flexible components arranged end to end. During suturing, the needle 220 enters the suture cavity 230, thereby piercing the exposed tissue support 240A in the plurality of tissue supports 240. When the exposed tissue support 240A is taken away from the deployment device 235 attached to the needle 220, the biasing device 244 can make the next tissue support in the plurality of tissue supports 240 enter the suture cavity 230 to be subsequently engaged by the needle 220 when passing through the next time. Each time the needle 220 passes through the tissue, one or more of the plurality of tissue supports 240 can be added so that the interface between the suture and the tissue becomes more solid as the operation continues. In some embodiments, the deployment device 235 can include a rigid plate 246 behind the exposed tissue support 240A to prevent the needle 220 from extending into the housing 238. In addition, the deployment device 235 can include a protrusion 248 that can keep the exposed tissue support 240A aligned within the suture cavity 230.

[0042] Now turn to Figures 3A to 3B , various deployment devices according to embodiments of the present invention will be described in more detail. As shown, the deployment device 335 may include a plurality of tissue supports 340 stacked on top of each other within a housing 338. The deployment device 335 may include a cover 350 extending across the housing 338. Figure 3A In an embodiment of the present invention, the cover 350 can include one or more membranes 351 extending across the housing 338. The membrane 351 can define a slot or opening 352 to allow access to the plurality of tissue supports 340 by a needle (not shown). The membrane 351 can be durable enough to hold the plurality of tissue supports 340 in place within the deployment device 335, but flexible enough to allow an exposed tissue support of the plurality of tissue supports 340 to be pulled out of the deployment device 335 by the needle.

[0043] exist Figure 3B In an embodiment of the present invention, the cover 350 may include multiple components, such as a slat 354 extending across the frame 356 of the housing 338 to hold multiple tissue supports in place. In various examples, the multiple slats 354 may be oriented laterally, longitudinally, and / or diagonally. As shown, the multiple slats 354 may define an opening 358 to allow a needle to enter the deployment device 335 and pierce an exposed tissue support in the multiple tissue supports 340. The exposed tissue support may then be folded or bent and subsequently pulled through the opening 358.

[0044] like Figure 4A , the deployment device 435 may include a mandrel 460 within a housing 438. In some embodiments, the mandrel 460 may be a tubular assembly defining a central channel 461 therein. As will be described in more detail below, the central channel 461 allows a needle to enter the deployment device 435 and retain one or more of the plurality of tissue supports 440. In this embodiment, the plurality of tissue supports 440 may be cylindrical washers concentrically disposed around an outer surface 462 of the mandrel 460. In addition, the plurality of tissue supports 440 may be elastically expandable to fit the mandrel 460 into the deployment device 435. After deployment, the plurality of tissue supports 440 may be retracted or deflated to effectively close around the suture.

[0045] Now turn to Figures 4B to 4E , will describe the instructions in more detail Figure 4A A cross-sectional view of the operation of the deployment device 435. Figure 4B As shown, the deployment device 435 includes a plurality of tissue supports 440 (e.g., four) disposed around a mandrel 460. The deployment device 435 can operate with a needle shuttle system 464, which can include two or more nested hypotubes, such as an inner tube 466 and an outer tube 468, which can be operated to shuttle the needle 420 and suture 421 back and forth through the target tissue 422. In some embodiments, a set of forks 470 can extend from the inner tube 466. In various examples, the inner tube 466 and the outer tube 468 can move together or independently.

[0046] like Figure 4C As shown, the inner tube 466 of the needle shuttle system 464 can pass distally over the needle 420 to interact with the deployment device 435. For example, the fork 470 on the end of the inner tube 466 can be deformable to fit beside / near the plurality of tissue supports 440. In some embodiments, the depth of the fork 470 entering the deployment device 435 can be controlled by the operator at a handle (not shown). In other embodiments, the fork 470 only abuts the proximal end 469 of the deployment device 435. Although not shown, the deployment device 435 can include a spring system (e.g., one or more springs or other biasing mechanisms) incorporated into the distal end 467 of the deployment device 435 to continuously or selectively push the plurality of tissue supports 440 to the proximal end 469 to engage with the fork 470. For example, in response to the needle being received in the deployment device 435, the most proximal tissue support 440 can be deployed onto the fork 470.

[0047] When the needle shuttle system 464 is retracted from the deployment device 435, the outermost tissue support 440A of the plurality of tissue supports 440 can be removed from the mandrel 460, for example, as Figure 4DIn some embodiments, the outermost tissue support 440A can extend around the suture 421 and remain on the fork 470 while the inner tube 466 moves further away from the deployment device 435. The outermost tissue support 440A can be retracted, thereby being held on the fork 470 by tension. In addition, the fork can include one or more curved ends 472 (e.g., curved radially outward) to prevent the outermost tissue support 440A from sliding off the fork 470.

[0048] Next, if Figure 4E As shown, the outer tube 468 of the needle shuttle system 464 can be advanced distally relative to the inner tube 466, thereby pushing the outermost tissue support 440A away from the fork 470 and onto the suture 421, for example, between the needle 420 and the target tissue 422. The position of the outer tube 468 can then be reset relative to the inner tube 466, so that the needle shuttle system 464 is ready for another needle pass. In some embodiments, no tissue support may be added between each suture pass. In addition, it should be understood that the number of tissue supports deployed depends on the needs of the surgery, the physician and / or the ability of the deployment device 435. The embodiments herein are not limited to this context.

[0049] Now turn to Figures 5 to 6 , a tissue suturing device (hereinafter referred to as "device") 510 according to an embodiment of the present invention will be described. The device 510 may include a head or cap 515 having a fixed end 516 that can be coupled to an endoscope (not shown) and a free end 518 opposite the fixed end 516. In some embodiments, the cap 515 can be formed integrally with an endoscope or other instrument. During use, a needle 520 and a suture 521 can pass back and forth between the fixed end 516 and the free end 518 along the longitudinal axis, thereby piercing a target tissue (not shown) positioned in a suturing cavity 530.

[0050] As further shown, the device 510 can include a deployment device 535 connected to the fixed end 516 of the cap 515. In this embodiment, the deployment device 535 can include a plurality of tissue supports 540A-540B extending around the collar 572. During assembly, a suture 521 connected to the needle 520 can be threaded between the tissue supports 540A and 540B to allow the most distally positioned tissue support 540A to be placed between the needle 520 and the tissue.

[0051] As shown, the collar 572 can fix the device 510 on the distal end of the endoscope. In other embodiments, the collar 572 can be formed integrally with the endoscope or other tubular instruments. Although non-limiting, each of the multiple tissue supports 540A-540B can be a washer-shaped support arranged around the outside of the collar 572. The collar 572 can define a collar opening 574 aligned with the working channel of the endoscope. As will be described in more detail below, during suturing, the needle 520 can pass in and out of the collar opening 574. When located on the collar 572, the multiple tissue supports 540 are stretched to be deployed above the needle 520 and the suture 521. When the suture 521 is pulled at the proximal handle of the device 510, each of the multiple tissue supports 540 can be deployed separately. Advantageously, multiple tissue supports 540A-540B may be deployed on opposite sides of target tissue that is being tightened together, for example, after the operator has passed needle 520 through the target tissue a desired number of times but before suture 521 is tightened.

[0052] In some embodiments, multiple tissue supports 540 are deployed using additional sutures (not shown). For example, additional sutures can be connected to one or more of multiple tissue supports 540A-540B. As the additional sutures are pulled toward the fixed end 516, the additional sutures can release the tissue support 540A positioned at the farthest side from the collar 572. In some embodiments, the collar 572 may include a hole (not shown) through its side wall that allows the additional suture to leave the central orifice of the collar 572. Having multiple tissue supports 540A-540B located on the collar 572 with the additional sutures can allow the needle 520 to shuttle back and forth normally, as many times as the operator needs.

[0053] Now turn to Figures 7A to 7H , the operation of the apparatus 510 according to an embodiment of the present invention will be described in more detail. Figures 7A to 7B In the embodiment of the present invention, the needle 520 and the suture 521 can pass through the first target tissue 522 and then pass through the second target tissue 522, such as Figures 7C to 7D As shown. Figures 7E to 7F As shown, the needle 520 can then be pulled through the collar 572 of the deployment device 535 and into the working channel 575 of the endoscope 514. In some embodiments, the suture 521 can extend only around the tissue support 540A positioned most distally. Figure 7GAs shown, the tissue support 540A positioned most distally can be released from the deployment device 535 and then brought into position on one side of the target tissue 522. The second tissue support 540B can then be released from the deployment device 535 and then brought into position on the opposite side of the target tissue 522, as shown in FIG. Figure 7H In some embodiments, the endoscope 514 ( Figure 7F ) can be moved away from the target tissue 522 to bring the needle 520 into contact with one side of the target tissue 522 while pulling the suture 521 to deploy the second tissue support 540B onto the target tissue 522. Finally, as Fig.7I As shown, the suture 521 can be tightened and secured, for example, using a tightening device 578. The tightening device 578 can bring the distally positioned tissue support 540A and the second tissue support 540B on opposite sides of the target tissue 522 closer together by pulling the suture 521 to bring the needle 520 toward the deployment device 535.

[0054] Now turn to Figures 8A to 8D , a suture 821 according to an embodiment of the present invention will be described. The suture 821 may include a rigid or semi-rigid tip 823 operable to pierce a target tissue 822. The rigid tip 823 may be connected to a plurality of flexible strands or filaments 825. Fig. 8A As shown, suture 821 can initially pass through target tissue 822 in the direction indicated by arrow 827. In this configuration, the filaments are generally straight and elongated. Figure 8B As shown, suture 821 may include one or more retaining wires 829 surrounding filament 825. Retaining wire 829 may be used to pull suture 821 back toward target tissue 822, for example, along Figure 8C The suture 821 is pulled toward the target tissue 822 to cause the filaments 825 to radially extend, thereby creating a maleco structure against the surface 831 of the target tissue 822. Fig.8D As shown, due to the expanded configuration of the filament 825, the interface 833 between the filament 825 and the target tissue 822 can generally have a larger area. Therefore, the force is better distributed at the interface 833, so that the target tissue 822 is less likely to rupture.

[0055] Now turn to Figures 9A to 9D , a suture 921 according to an embodiment of the present invention will be described. Suture 921 may include a rigid tip 923 connected to a polymer body 939, wherein the polymer body 939 may be rigid or flexible. Fig. 9AAs shown, suture 921 may initially be passed through interface 933 of target tissue 922 in the direction indicated by arrow 927. In this configuration, polymer body 939 is generally straight and elongated. However, as shown in FIG. Fig. 9B As shown, the outer material 943 of the polymer body 939 can expand or grow radially when in contact with a fluid (not shown), such as water, saline, blood, or the like.

[0056] In some embodiments, the outer material 943 of the polymer body 939 can be a hydrogel. The term "hydrogel" can refer to a cross-linked, water-insoluble, water-containing material. Suitable cross-linkable polymers include, but are not limited to, a mixture of one or more polymers selected from the group consisting of polyhydroxyethyl methacrylate, polyvinyl alcohol, polyacrylamide, poly(N-vinyl pyrrolidone), polyethylene oxide, hydrolyzed polyacrylonitrile, polyacrylic acid, polymethacrylic acid, polyvinylamine, alginic acid, pectic acid, carboxymethyl cellulose, hyaluronic acid, heparin, heparin sulfate, chitosan, carboxymethyl chitosan, chitin, pullulan, gellan gum, xanthan gum, carboxymethyl starch, carboxymethyl dextran, chondroitin sulfate, cationic guar gum, cationic starch, and salts and esters thereof. The resulting hydrogel can have improved mechanical properties at the interface 933, such as improved stiffness, modulus, yield stress, strength, etc.

[0057] like Fig. 9C As shown, as the suture 921 is retracted, the outer material 943 of the polymer body 939 begins to bunch. Fig.9D As shown, further retraction of the suture 921 toward the target tissue 922 causes the outer material 943 to gather into a bundle along the surface 931 of the target tissue 922. Due to the expansion of the outer material 943, the interface 933 between the outer material 943 and the target tissue 922 generally has a larger area. Therefore, the force is better distributed at the interface 933, thereby making it less likely that the target tissue 922 will rupture.

[0058] Now turn to Figures 10A to 10C , a suture 1021 according to an embodiment of the present invention will be described. As shown, the suture 1021 may include a core 1047 surrounded by a sheath 1049. A portion of the core 1047 extending outside the sheath 1049 may correspond to a tip 1053 of the suture 1021. In some embodiments, the sheath 1049 can be radially expanded from the core 1047. In addition, the sheath 1049 can move independently of the core 1047 to allow the sheath to be bundled, such as Fig. 10CIn this embodiment, the sheath 1049 can be a continuous or sheet-like covering that sphericalizes and buckles when the core 1047 expands and retracts, thereby forming a secure plug-like interface (not shown) where the suture 1021 contacts the target tissue. In some embodiments, the sheath 1049 is concentrically disposed around the core 1047.

[0059] exist Figures 11A to 11B In some embodiments, the sheath 1149 of the suture 1121 can include multiple flexible strands. As shown, as the core 1147 of the suture 1121 is retracted, the flexible strands gather together, thereby expanding to form a mesh network with an increased surface area. In some embodiments, the sheath 1149 is concentrically arranged around the core 1147.

[0060] Now turn to Figures 12A to 12B , the use of a sprayable adhesive 1280 applied to an area of ​​a target tissue 1222 according to an embodiment of the present invention will be described in more detail. As shown, the sprayable adhesive 1280 can be delivered through an endoscope 1214. The sprayable adhesive 1280 can be applied to the target tissue 1222 at each interface 1233 where the suture 1221 and the needle 1220 penetrate the target tissue 1222. Therefore, the interface 1233 may be less likely to tear under the pulling of the suture 1221.

[0061] During use, a physician can perform an endoscopic procedure. The physician can retract the device occupying the working channel (e.g., a visualization device) and advance the needle or catheter 1281. Once the feature reaches the working channel, for example, a syringe (not shown) with a medical grade silicone-based spray adhesive is connected to the proximal end of the catheter 1281 (e.g., via a Luer connector). The syringe can be actuated, forcing the sprayable adhesive 1280 to spray out from the distal end of the endoscope 1214. Fig. 12B As shown, as the sprayable adhesive solidifies, the surface of the target tissue 1222 contacted by the tightening member 1282 and the needle 1220 will harden and resist expansion, thereby preventing the tightening member 1281 and / or the needle from passing through the hole in the target tissue 1222 at each interface 1233.

[0062] exist Figures 13A to 13CIn a non-limiting embodiment, a curable glue 1380 (e.g., moisture or UV curable) can be added to the target tissue 1322 at each end of the suture 1321 to distribute the force applied to the interface 1333 between the target tissue 1322 and the suture 1321. Due to the flexible nature of the curable glue 1380 before curing, the curable glue 1380 can be more easily passed through the working channel of the endoscope 1314 and applied to the target tissue 1322. In addition, the curable glue 1380 can allow the physician to better customize the final shape of the curable glue 1380 based on the needs of the surgery, the location of the wound, his / her preferences, etc. For example, as Figures 13B to 13C As shown, the curable glue 1380 can be formed into one or more cylindrical washers 1385 each having a central opening 1387. Fig. 13C ) can pass through the central opening 1387. In addition, the use of curable glue 1380 also gives the physician the freedom to add additional glue at various points during the procedure, for example, to improve force distribution as needed before or after suturing. In some embodiments, as Fig. 13C As shown, after suturing, the suture line 1320 can remain on top of the curable glue 1380. To improve visibility, in an alternative embodiment, the curable glue 1380 can also be dyed.

[0063] exist Figures 14A to 14C In a non-limiting embodiment, one or more tubular tissue supports (e.g., washers) 1440 may be used on opposite sides of the target tissue 1422. As shown, the tubular tissue support 1440 may include a slot 1489 through which the suture 1421 may pass, thereby allowing the tubular tissue support 1440 to be placed anywhere along the suture 1421 after the suture 1421 has passed through the target tissue 1422. In some embodiments, the tubular tissue support 1440 may be delivered endoscopically and manipulated to the appropriate position using a grasper or similar tool after the suture 1421 is placed, but before the suture 1421 is tightened.

[0064] Now turn to Fig.15, a tissue support in the form of one or more elastic elements or spring-loaded wires will be described. As shown, when the needle 1520 and suture 1521 are advanced through the target tissue 1522, the wire 1590 can be deployed from the endoscope 1514 and deployed onto the suture 1521. In the non-limiting embodiment shown, the wire 1590 can be a metal spring-loaded wire with shape memory, which is preloaded into the delivery catheter of the endoscope 1514. When the wire 1590 is advanced beyond the distal tip of the endoscope 1514, it begins to curl. The wire 1590 can form a hook 1592 when it begins to curl, which can engage the suture 1521 between the tightening member 1591 and the target tissue 1522 and / or between the needle 1520 and the target tissue 1522.

[0065] Once the suture 1521 is obtained by the hook 1592, the rest of the line 1590 can then be sent out of the endoscope 1514. The line 1590 continues to curl until the proximal end is discharged. The use of the line 1590 allows for a low profile during delivery and once deployed, a large solid surface area for the tightening member 1591 and the needle 1520 to engage, thereby preventing pull-through. In a non-limiting embodiment, the line 1590 can be made of steel, nitinol, or any other material with a high spring constant. In other embodiments, the line 1590 can also present a ribbon-like profile, which can also increase the contact surface area between the line 1590 and the tightening member 1591 and the needle 1520.

[0066] Alternatively, the wire 1590 can be a bistable spring that is straight in one direction and curved in another direction. The wire 1590 can be advanced until it is positioned between the tightening member 1591 and the needle 1520. Once properly positioned, the spring can then be transferred to a second orientation, thereby bending it into a coil or helical orientation.

[0067] Now turn to Fig.16 , method 1600 according to an embodiment of the present invention will be described in more detail. At frame 1601, the method may include passing a needle and a suture of a tissue suturing device through a target tissue, and the tissue suturing device extends from the distal end of the endoscope. In some embodiments, a plurality of tissue supports are contained within a deployment device, wherein a first tissue support is exposed within a suturing cavity. In some embodiments, the deployment device may be a barrel or a collar. In some embodiments, a cover may extend across the deployment device, and the cover includes an opening to allow access to a plurality of tissue supports by a needle. In some embodiments, the tissue support may include one or more of the following: a flexible gasket, an adhesive, a wadding, and an elastic or spring-loaded wire.

[0068] At frame 1603, the method 1600 may include deploying a first tissue support from a tissue stapling device to a position along a first portion of the target tissue. In some embodiments, the first tissue support may be engaged within a suturing cavity by a needle to remove the first tissue support from the deployment device. At frame 1605, the method 1600 may include deploying a second tissue support from the tissue stapling device to a position along a second portion of the target tissue, wherein tightening the suture brings the first tissue support and the second tissue support closer together.

[0069] Although the illustrative method 1600 is described above as a series of actions or events, unless otherwise specified, the present invention is not limited by the shown order of these actions or events. For example, according to the present invention, some actions can occur in a different order and / or simultaneously with other actions or events other than those shown and / or described herein. In addition, not all illustrated actions or events need to be implemented according to the method of the present invention. In addition, the method 1600 can be implemented in association with the formation and / or processing of the structures shown and described herein, as well as in association with other structures not shown.

[0070] The expressions "coupled" and "connected" and their derivatives may be used to describe some embodiments. These terms are not intended to be synonymous with each other. For example, the terms "connected" and / or "coupled" may be used to describe some embodiments to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "coupled" may also mean that two or more elements are not in direct contact with each other, but still cooperate or interact with each other.

[0071] As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will also be understood that when used herein, the terms "include" and / or "comprise" or "include" and / or "comprising" specify the presence of stated features, regions, steps, elements and / or components, but do not exclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and / or groups.

[0072] In addition, the terms "substantially" or "substantially" and the terms "approximately" or "approximately" can be used interchangeably in some embodiments and can be described using any relevant measurement values ​​acceptable to the skilled person. For example, these terms can be used as a comparison to a reference parameter to indicate a deviation that will still provide the intended function. Although non-limiting, the deviation from the reference parameter can be, for example, an amount less than 1%, less than 3%, less than 5%, less than 10%, less than 15%, less than 20%, etc.

[0073] Although specific embodiments have been shown and described herein, it should be understood that any arrangement calculated to achieve the same purpose may replace the specific embodiments shown. The present invention is intended to cover any and all adaptations or modifications of the various embodiments. It should be understood that the above description is in an illustrative manner, rather than a restrictive manner. After reviewing the above description, the combination of the above-described embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art. Therefore, the scope of the various embodiments includes any other application in which the above-described compositions, structures, and methods are used.

[0074] Although the subject matter has been described in language specific to structural features and / or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims.

Claims

1. A tissue suturing device for use with an endoscope, comprising a tissue suturing device that can be coupled to the distal end of the endoscope, The tissue suturing device comprises: a cap having a fixed end coupled to the endoscope and a free end opposite to the fixed end; a plurality of tissue supports, wherein each of the plurality of tissue supports is deployable toward a target tissue, and wherein one or more of the plurality of tissue supports receives a suture during deployment; wherein the plurality of tissue supports comprises one or more of: a flexible gasket, a sprayable adhesive, wadding, and a spring loaded wire; a needle, wherein the needle engages one of the plurality of tissue supports to deploy the tissue support; a tissue grasper delivered through the channel of the cap to engage the target tissue; A deployment device, the deployment device comprising: a housing containing the plurality of tissue supports, wherein the plurality of tissue supports are contained within the deployment device prior to deployment; and a cover extending across the housing, the cover including an opening to allow access to the plurality of tissue supports by a needle attached to the suture; and A suturing cavity is located between the fixed end and the free end; wherein the tissue grasper engages the target tissue to bring the target tissue into the suturing cavity.

2. The tissue suturing device according to claim 1 further comprises a collar extending from a fixed end of the tissue suturing device, wherein the collar defines a collar opening aligned with a working channel of the endoscope, and wherein the plurality of tissue supports extend around the exterior of the collar prior to deployment.

3. The tissue stapling apparatus according to claim 1, wherein the deployment device comprises an internal channel and a biasing device for biasing the plurality of tissue supports within the internal channel, wherein the plurality of tissue supports are arranged end-to-end within the internal channel.

4. The tissue stapling apparatus of claim 1, wherein the deployment device comprises a mandrel defining a central channel, wherein each of the plurality of tissue supports is concentrically disposed about the mandrel.

5. The tissue stapling device according to claim 1, wherein the suture comprises: Core; as well as A sheath is provided, wherein the sheath is operable to radially expand from the core in an area adjacent the target tissue.

6. The tissue stapling device of claim 5, wherein the sheath comprises a plurality of flexible strands.

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