Device for increasing force distribution at the suture-tissue interface - Patent Application 20070122999

Abstract

To provide, generally, apparatuses, devices and methods for increasing force distribution at a suture-tissue interface.SOLUTION: A tissue suturing device 510 includes a deployment device 535 and a plurality of tissue supports 540A, 540B deployable from the deployment device 535 towards a target tissue 522. The tissue supports 540A, 540B each include a central opening for receiving a suture 521 during deployment.SELECTED DRAWING: Figure 7H

Description

[Technical Field]

[0001] The present invention relates to suturing devices, and more particularly to suturing devices for increasing the distribution of forces at the suture-tissue interface. [Background technology]

[0002] Sutures are used during various endoscopic procedures, such as wound closure, fixation of stents or other implants, and shortening of the gastric curvature. Several types of sutures and devices have been developed for implantation and extraction. In some approaches, suturing is performed by repeatedly passing a sharp suture needle attached to a length of suture material through the section of tissue to be sutured. The two free ends of the suture material are then tied to complete the suturing procedure.

[0003] Many endoscopic procedures involve drawing tissue together and holding it in a new configuration. However, as the tissue is reconfigured and restrained, tension is generated between the tissue and the suture. While current suture and suturing approaches provide an adequate and temporary solution for holding tissue, over time the forces required to hold the tissue in place become too great to maintain equilibrium. As a result, the suture can tear the tissue as it relaxes. With the above considerations in mind, the improvements of the present invention may be useful. Summary of the Invention

[0004] The present invention, in various embodiments, relates generally to devices, apparatus, and methods for redistributing forces at the tissue-suture interface to enhance the long-term effectiveness of endoscopic suturing procedures.

[0005] In one or more embodiments, a tissue suturing device for use with an endoscope includes a tissue suturing device coupleable to a distal end of the endoscope, the tissue suturing device including a plurality of tissue supports, each of which is deployable to a target tissue, and one or more of the plurality of tissue supports receiving a suture during deployment. In some embodiments, the tissue suturing device further includes a needle, which engages a tissue support of the plurality of tissue supports to deploy the tissue support. In some embodiments, the tissue suturing device further includes a collar extending from a fixed end of the tissue suturing device, the collar defining a collar opening aligned with a working channel of the endoscope, and each of the plurality of tissue supports extending around the collar prior to deployment. In some embodiments, the deployment device includes a housing including the plurality of tissue supports and a cover extending across the housing, the cover including an opening allowing access to the plurality of tissue supports by a needle attached to a suture. In some embodiments, the deployment device includes an internal channel and a biasing device for biasing the plurality of tissue supports within the internal channel, the plurality of tissue supports being disposed end-to-end within the internal channel. In some embodiments, the deployment device includes a mandrel defining a central channel, and the plurality of tissue supports are each concentrically disposed about the mandrel. In some embodiments, the suture includes a core and a sheath, and the sheath is operable to expand radially from the core into a region adjacent the target tissue. In some embodiments, the sheath includes a plurality of flexible strands. In some embodiments, the plurality of tissue supports include one or more of a flexible washer, a sprayable adhesive, a pledget, and a spring-loaded wire.

[0006] In one or more embodiments, the tissue suturing device includes a deployment device and a plurality of tissue supports deployable from the deployment device toward the target tissue. The plurality of tissue supports include a central opening for receiving sutures during deployment. In some embodiments, the tissue suturing device further includes a fixed end secured to the distal end of the endoscope and a free end opposite the fixed end, and the deployment device is coupled to one of the fixed end and the free end. In some embodiments, the deployment device includes a collar extending from the fixed end, the collar defining a collar opening aligned with the working channel of the endoscope, and each of the plurality of tissue supports extends around the collar prior to deployment. In some embodiments, the deployment device includes a housing enclosing the plurality of tissue supports and a cover extending across the housing, the cover including an opening allowing access to the plurality of tissue supports by needles attached to the sutures. In some embodiments, the housing includes an internal channel and a biasing device for biasing the plurality of tissue supports within the internal channel, the plurality of tissue supports being disposed end-to-end within the internal channel.

[0007] In one or more embodiments, the method includes passing a needle and a suture of a tissue suturing device through the target tissue, the tissue suturing device extending from the distal end of the endoscope. The method further includes deploying a first tissue support from the tissue suturing device to a position along a first portion of the target tissue and deploying a second tissue support from the tissue suturing device to a position along a second portion of the target tissue, wherein cinching the suture approximates the first and second tissue supports. In some embodiments, the method further includes housing a plurality of tissue supports within a deployment device, the first tissue support being exposed within a suture cavity, engaging the first tissue support within the suture cavity with a needle to release the first tissue support from the deployment device, exposing the second tissue support within the suture cavity, and engaging the second tissue support within the suture cavity with the needle to release the second tissue support from the deployment device. In some embodiments, the method further includes accessing the plurality of tissue supports through an opening in a cover extending across the deployment device. In some embodiments, the method further includes biasing the plurality of tissue supports toward the suture cavity using a biasing device. In some embodiments, the method includes disengaging a first tissue support from the tissue suturing device using the set of prongs, disengaging the first tissue support from the set of prongs onto the suture, disengaging a second tissue support from the tissue suturing device using the set of prongs, and disengaging the second tissue support from the set of prongs onto the suture.

[0008] For use in connection with the devices, apparatus, and methods outlined above, and with respect to the embodiments described in more detail below and within the scope of this specification, one or more of the various features outlined above may be substituted, exchanged, combined, or substituted for other elements outlined above.

[0009] Non-limiting embodiments of the present invention are described by way of example with reference to the accompanying drawings, which are schematic and are not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown in the figures is typically represented by a single numeral. For clarity, not every component is labeled in every figure, and not every component of each embodiment is shown unless illustration is necessary to enable those skilled in the art to understand the disclosure. Furthermore, for purposes of clarity, some figures include cross-sectional views in the form of "slices" or "close-up" cross-sections, and for purposes of illustration, certain background lines or features that would appear in a "true" cross-section have been omitted. [Brief explanation of the drawings]

[0010] [Figure 1] 1 is a side view showing a tissue suturing device according to an embodiment of the present invention. [Figure 2] 2 is a side cross-sectional view of an exemplary deployment device of the tissue suturing device of FIG. 1 in accordance with an embodiment of the present invention. [Figure 3A] 3 is a front view of an exemplary cover for the deployment device of FIG. 2 in accordance with an embodiment of the present invention. [Figure 3B] 3 is a front view of an exemplary cover for the deployment device of FIG. 2 in accordance with an embodiment of the present invention. [Figure 4A] 2 is an end view of an exemplary deployment device of the tissue suturing device of FIG. 1 in accordance with an embodiment of the present invention. [Figure 4B] 4B is a side cross-sectional view illustrating a process for using the deployment device of FIG. 4A according to an embodiment of the present invention. [Figure 4C] 4B is a side cross-sectional view illustrating a step for using the deployment device of FIG. 4A according to an embodiment of the present invention. [Figure 4D] 4B is a side cross-sectional view illustrating a step for using the deployment device of FIG. 4A according to an embodiment of the present invention. [Figure 4E] 4B is a side cross-sectional view illustrating a step for using the deployment device of FIG. 4A according to an embodiment of the present invention. [Figure 5] 1 is a perspective view illustrating an example deployment device according to an embodiment of the present invention. FIG. [Figure 6]FIG. 6 is a perspective view, partially in section, of the deployment device of FIG. 5 in accordance with an embodiment of the present invention. [Figure 7A] 7A-7C are side views illustrating steps for using the deployment device of FIGS. 5-6 according to an embodiment of the present invention. [Figure 7B] 7A-7C are side views illustrating steps for using the deployment device of FIGS. 5-6 according to an embodiment of the present invention. [Figure 7C] 7A-7C are side views illustrating steps for using the deployment device of FIGS. 5-6 according to an embodiment of the present invention. [Figure 7D] 7A-7C are side views illustrating steps for using the deployment device of FIGS. 5-6 according to an embodiment of the present invention. [Figure 7E] 7A-7C are side views illustrating steps for using the deployment device of FIGS. 5-6 according to an embodiment of the present invention. [Figure 7F] 7A-7C are side views illustrating steps for using the deployment device of FIGS. 5-6 according to an embodiment of the present invention. [Figure 7G] 7A-7C are side views illustrating steps for using the deployment device of FIGS. 5-6 according to an embodiment of the present invention. [Figure 7H] 7A-7C are side views illustrating steps for using the deployment device of FIGS. 5-6 according to an embodiment of the present invention. [Figure 7I] 7A-7C are side views illustrating steps for using the deployment device of FIGS. 5-6 according to an embodiment of the present invention. [Figure 8A] 1 is a perspective view illustrating the use of an exemplary suture according to an embodiment of the present invention; [Figure 8B] 1 is a perspective view illustrating the use of an exemplary suture according to an embodiment of the present invention; [Figure 8C] 1 is a perspective view illustrating the use of an exemplary suture according to an embodiment of the present invention; [Figure 8D] 1 is a perspective view illustrating the use of an exemplary suture according to an embodiment of the present invention; [Figure 9A] 1 is a perspective view illustrating the use of an exemplary suture according to an embodiment of the present invention; [Figure 9B] 1 is a perspective view illustrating the use of an exemplary suture according to an embodiment of the present invention; [Figure 9C] 1 is a perspective view illustrating the use of an exemplary suture according to an embodiment of the present invention; [Figure 9D] 1 is a perspective view illustrating the use of an exemplary suture according to an embodiment of the present invention; [Figure 10A] FIG. 1 is a side view of an exemplary suture according to an embodiment of the present invention. [Figure 10B] FIG. 10B is a top cross-sectional view of the suture of FIG. 10A in accordance with an embodiment of the present invention. [Figure 10C] FIG. 10B is a side view of the suture of FIG. 10A after retraction of the suture in accordance with an embodiment of the present invention. [Figure 11A] FIG. 1 is a top cross-sectional view of an exemplary suture according to an embodiment of the present invention. [Figure 11B] FIG. 11B is a side view of the suture of FIG. 11A after contraction of the suture in accordance with an embodiment of the present invention. [Figure 12A] 1 is a perspective view illustrating the use of a sprayable adhesive applied to an area of ​​tissue according to an embodiment of the present invention. [Figure 12B] 1 is a perspective view illustrating the use of a sprayable adhesive applied to an area of ​​tissue according to an embodiment of the present invention. [Figure 13A] FIG. 1 is a perspective view illustrating the use of adhesive applied to an area of ​​tissue according to an embodiment of the present invention. [Figure 13B] FIG. 1 is a perspective view illustrating the use of adhesive applied to an area of ​​tissue according to an embodiment of the present invention. [Figure 13C] FIG. 1 is a perspective view illustrating the use of adhesive applied to an area of ​​tissue according to an embodiment of the present invention. [Figure 14A] 1 is a perspective view illustrating the use of a tubular tissue support according to an embodiment of the present invention. [Figure 14B] 1 is an exemplary perspective view of a tubular tissue support according to an embodiment of the present invention. [Figure 14C] FIG. 10 is a perspective view of another exemplary tubular tissue support according to an embodiment of the present invention. [Figure 15] 1 is a perspective view illustrating the use of a spring-loaded wire according to an embodiment of the present invention. [Figure 16] FIG. 1 is a flow diagram illustrating a method according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0011] The present invention is not limited to the specific embodiments described herein. The terms used herein are intended only to describe specific embodiments and are not intended to limit the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by those skilled in the art to which the present invention belongs.

[0012] The embodiments described herein disclose endoscopic tissue suturing instruments, devices, and methods for increasing force distribution at the suture-tissue interface. Those skilled in the art will appreciate that although the inventive approach is described herein with reference to suturing areas of the stomach, the approach may be utilized in other gastrointestinal procedures and may be introduced orally and anally.

[0013] Without limitation, the approach of the present invention may be effective in treating gastroesophageal reflux disease (GERD) by performing a procedure such as a partial circumferential endoscopic mucosal resection (EMR) or submucosal dissection (ESD) of a patient's gastrointestinal tract.

[0014] Referring to FIG. 1, a tissue suturing device (hereinafter, "device") 100 according to an embodiment of the present invention will be described. As shown, device 100 includes tissue suturing device (hereinafter, "device") 110 extending from a distal end 112 of a scope, such as an endoscope 114. Device 110 can also be used with other types of scopes, such as a bronchoscope, duodenoscope, gastroscope, or colonoscope. Device 110 includes a head or cap 115 having a fixed end 116 directly coupled to endoscope 114 and a free end 118 opposite fixed end 116. In some embodiments, cap 115 can be coupled to endoscope 114 using various techniques, such as mechanical fasteners, adhesives, sutures, press-fitting, tape, or overmolding. In another embodiment, the dispenser cap is integrally formed with the endoscope.

[0015] In use, needle 120 reciprocates along a longitudinal axis between fixed end 116 and free end 118, with needle 120 including one or more sharp tips for piercing target tissue 122 with each pass. In some embodiments, tissue grasper 124 is conveyed through channel 126 in cap 115 to engage target tissue 122 and position target tissue 122 within suture cavity 130 located between fixed end 116 and free end 118.

[0016] The device 110 includes a deployment device 135 that includes multiple tissue supports (not shown) therein. As described in more detail below, the tissue supports are 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 is coupled to a free end 118 of the device 110 that is positioned generally opposite the fixed end 116.

[0017] Referring now to FIG. 2 , an exemplary deployment device 235 according to an embodiment of the present invention will be described. As shown, the deployment device 235 is a cartridge including a housing 238 having a plurality of tissue supports 240 therein. The housing 238 includes an internal channel 242 and a biasing device 244 (e.g., a spring) for biasing the plurality of tissue supports 240 through the internal channel 242. In some embodiments, the plurality of tissue supports 240 are solid, flexible components from one end to the other. During suturing, the needle 220 enters the suture cavity 230 and pierces an exposed tissue support 240A of the plurality of tissue supports 240. As the exposed tissue support 240A is removed from the deployment device 235 and attached to the needle 220, the biasing device 244 moves the next tissue support of the plurality of tissue supports 240 into the suture cavity 230 and engages it upon the next pass of the needle 220. As one or more of the plurality of tissue supports 240 are added each time the needle 220 passes through the tissue, the interface between the suture and the tissue becomes stronger as the procedure continues. In some embodiments, the deployment device 235 includes a rigid plate 246 positioned behind the exposed tissue support 240A to prevent the needle 220 from extending into the housing 238. Additionally, the deployment device 235 includes a protrusion 248 that maintains the exposed tissue support 240A aligned within the suture cavity 230.

[0018] 3A-3B, various deployment devices according to embodiments of the present invention will be described in more detail. As shown, deployment device 335 includes a plurality of tissue supports 340 stacked on top of one another within housing 338. Deployment device 335 includes a cover 350 extending across housing 338. In the embodiment of FIG. 3A, cover 350 includes one or more membranes 351 extending across housing 338. Membrane 351 defines slots or openings 352 to allow access to the plurality of tissue supports 340 with a needle (not shown). Membrane 351 is sufficiently durable to hold the plurality of tissue supports 340 in place within deployment device 335, yet sufficiently flexible to allow exposed portions of the plurality of tissue supports 340 to be withdrawn from deployment device 335 with a needle.

[0019] In the embodiment of FIG. 3B , the cover 350 includes multiple components, such as slats 354, that extend across the frame 356 of the housing 338 to hold the multiple tissue supports 340 in place. In various examples, the multiple slats 354 may be oriented laterally, longitudinally, and / or diagonally. As shown, the multiple slats 354 define openings 358 that allow a needle to enter the deployment device 335 and pierce an exposed one of the multiple tissue supports 340. The exposed tissue support is then folded or bent and pulled through the openings 358.

[0020] As shown in FIG. 4A , the deployment device 435 includes a mandrel 460 within a housing 438. In some embodiments, the mandrel 460 is a tubular component having a central channel 461 therein. As described in more detail below, the central channel 461 allows a needle to enter the deployment device 435 to hold one or more of the plurality of tissue supports 440. In this embodiment, the plurality of tissue supports 440 are cylindrical washers arranged concentrically about an outer surface 462 of the mandrel 460. Furthermore, the plurality of tissue supports 440 elastically expand to fit the mandrel 460 within the deployment device 435. After deployment, the plurality of tissue supports 440 contract or compress to effectively close around the suture.

[0021] 4B-4E, cross-sectional views illustrating the operation of the deployment device 435 of FIG. 4A will be described in more detail. As shown in FIG. 4B, the deployment device 435 includes a plurality of tissue supports 440 (e.g., four) arranged around a mandrel 460. The deployment device 435 can be operated with a needle shuttle system 464, which includes two or more nested hypotubes, such as an inner tube 466 and an outer tube 468, operable to shuttle the needles 420 and sutures 421 back and forth through the target tissue 422. In some embodiments, a set of prongs 470 extends from the inner tube 466. In various examples, the inner tube 466 and the outer tube 468 move together or independently.

[0022] As shown in FIG. 4C , the inner tube 466 of the needle shuttle system 464 is advanced distally over the needle 420 to interact with the deployment device 435. For example, prongs 470 at the end of the inner tube 466 are deformable to fit alongside / adjacent to multiple tissue supports 440. In some embodiments, the depth to which the prongs 470 enter the deployment device 435 can be controlled by the operator with a handle (not shown). In other embodiments, the prongs 470 simply abut the proximal end 469 of the deployment device 435. Although not shown, the deployment device 435 includes a spring system (e.g., one or more springs or other biasing mechanism) integrated into the distal end 467 of the deployment device 435 to sequentially or selectively urge the multiple tissue supports 440 toward the proximal end 469 for engagement with the prongs 470. For example, when a needle is received in the deployment device 435, the proximal-most tissue support 440 is deployed onto the prongs 470.

[0023] 4D , for example, the outermost tissue support 440A of the plurality of tissue supports 440 is released from the mandrel 460. In some embodiments, the outermost tissue support 440A extends around the suture 421 and remains on the prongs 470 while the inner tube 466 moves further away from the deployment device 435. The outermost tissue support 440A contracts and remains on the prongs 470 by tension. Additionally, the prongs include one or more curved (e.g., curved radially outward) ends 472 to prevent the outermost tissue support 440A from slipping off the prongs 470.

[0024] Next, as shown in FIG. 4E , the outer tube 468 of the needle shuttle system 464 is advanced distally relative to the inner tube 466, pushing the outermost tissue support 440A distally from the prongs 470 onto the suture 421, e.g., between the needle 420 and the target tissue 422. The position of the outer tube 468 is then reset relative to the inner tube 466, so that the needle shuttle system 464 is ready for another needle pass. In some embodiments, tissue supports are not added after each suture pass. Furthermore, it can be appreciated that the number of tissue supports deployed depends on the needs of the procedure, the physician, and / or the capacity of the deployment device 435. The embodiments herein are not limited in this context.

[0025] 5-6, a tissue suturing device (hereinafter "device") 510 according to an embodiment of the present invention will be described. Device 510 includes a head or cap 515 having a fixed end 516 connectable to an endoscope (not shown) and a free end 518 opposite fixed end 516. In some embodiments, cap 515 is integrally formed with the endoscope or another instrument. During use, needle 520 and suture 521 are passed back and forth along the longitudinal axis between fixed end 516 and free end 518 to puncture target tissue (not shown) disposed within suture cavity 530.

[0026] The device 510 includes a deployment device 535 coupled to a fixed end 516 of a cap 515. In this embodiment, the deployment device 535 includes a plurality of tissue supports 540A-540B extending around a collar 572. During assembly, a suture 521 coupled to the needle 520 is threaded between the tissue supports 540A and 540B, allowing the most distally positioned tissue support 540A to be positioned between the needle 520 and the tissue.

[0027] As shown, a collar 572 secures the device 510 to the distal end of an endoscope. In another embodiment, the collar 572 is integrally formed with the endoscope or other tubular instrument. Without limitation, each of the plurality of tissue supports 540A-540B is a washer-like support disposed around the circumference of the collar 572. The collar 572 defines a collar opening 574 that aligns with the working channel of the endoscope. The needle 520 moves in and out of the collar opening 574 during suturing, as described in more detail below. While positioned on the collar 572, the plurality of tissue supports 540 are extended for deployment over the needle 520 and suture 521. When the suture 521 is pulled by the proximal handle of the device 510, each of the plurality of tissue supports 540 is deployed separately. Advantageously, multiple tissue supports 540A-540B are deployed on either side of the tensioned target tissue, for example, after the operator has passed needle 520 through the target tissue a desired number of times and before suture 521 is tightened.

[0028] In some embodiments, the multiple tissue supports 540 are deployed using an additional suture (not shown). For example, the additional suture is coupled to one or more of the multiple tissue supports 540A-540B. When the additional suture is pulled toward the fixed end 516, the additional suture disengages the most distally disposed tissue support 540A from the collar 572. In some embodiments, the collar 572 includes an opening (not shown) through a side wall of the collar 572, which allows the additional suture to exit through a central hole in the collar 572. With the multiple tissue supports 540A-540B disposed on the collar 572 along with the additional suture, the needle 520 can be shuttled back and forth as often as needed by the operator.

[0029] 7A-7H, the operation of the device 510 according to embodiments of the present invention will be described in more detail. In FIGS. 7A-7B, the needle 520 and suture 521 are passed through a first portion of the target tissue 522, and then through a second portion of the target tissue 522, as shown in FIGS. 7C-7D. Next, the needle 520 is pulled through the collar 572 of the deployment device 535 and into the working channel 575 of the endoscope 514, as shown in FIGS. 7E-7F. In some embodiments, the suture 521 extends only around the most distally positioned tissue support 540A. During deployment, the most distally positioned tissue support 540A is detached from the deployment device 535 and placed in position on one side of the target tissue 522, as shown in FIG. 7G. Next, the second tissue support 540B is detached from the deployment device 535 and placed in position on the opposite side of the target tissue 522, as shown in FIG. 7H. In some embodiments, the endoscope 514 (FIG. 7F) is moved away from the target tissue 522 to bring the needle 520 into contact with one side of the target tissue 522, while the suture 521 is tensioned to deploy the second tissue support 540B over the suture 521. Finally, as shown in FIG. 7I, the suture 521 is tensioned and secured, for example, using a clamping device 578. The clamping device 578 tensions the suture 521 to bring the needle 520 closer to the deployment device 535, thereby bringing the distal-most tissue support 540A and the second tissue support 540B on either side of the target tissue 522 closer together.

[0030] 8A-8D, a suture 821 according to an embodiment of the present invention is described. The suture 821 includes a rigid or semi-rigid tip 823 operable to penetrate a target tissue 822. The rigid tip 823 is connected to a plurality of flexible strands, or filaments, 825. As shown in FIG. 8A, the suture 821 initially passes through the target tissue 822 in the direction indicated by arrow 827. In this configuration, the filament is generally straight and elongated. As shown in FIG. 8B, the suture 821 includes one or more retention wires 829 surrounding the filament 825. The retention wires 829 can be used to retract the suture 821 toward the target tissue 822, for example, in the direction shown in FIG. 8C. Pulling the suture 821 toward the target tissue 822 causes the filaments 825 to radially expand and form a malecot configuration against the surface 831 of the target tissue 822. 8D, the interface 833 between the filament 825 and the target tissue 822 generally has a larger area due to the expanded configuration of the filament 825. Thus, forces are better distributed at the interface 833, making it less likely that the target tissue 822 will tear.

[0031] 9A-9D, a suture 921 according to an embodiment of the present invention is described. The suture 921 includes a rigid tip 923 coupled to a polymer body 939, which may be rigid or flexible. As shown in FIG. 9A, the suture 921 first passes through an interface 933 with a target tissue 922 in the direction indicated by arrow 927. In this configuration, the polymer body 939 is straight and elongated. However, as shown in FIG. 9B, the outer material 943 of the polymer body 939 may radially expand upon contact with a fluid (not shown), such as water, saline, or blood.

[0032] In some embodiments, the outer material 943 of the polymer body 939 is a hydrogel. The term "hydrogel" refers to a crosslinked, water-insoluble, water-containing material. Suitable crosslinkable polymers include, but are not limited to, one or a mixture of polymers selected from polyhydroxyethyl methacrylate, polyvinyl alcohol, polyacrylamide, poly(N-vinylpyrrolidone), polyethylene oxide, hydrolyzed polyacrylonitrile, polyacrylic acid, polymethacrylic acid, polyethyleneamine, alginic acid, pectinic acid, carboxymethylcellulose, hyaluronic acid, heparin, heparin sulfate, chitosan, carboxymethylchitosan, chitin, pullulan, gellan, xanthan, carboxymethylstarch, carboxymethyldextran, chondroitin sulfate, cationic guar, cationic starch, salts thereof, and esters thereof. The hydrogel product has improved mechanical properties at the interface 933, such as improved stiffness, modulus, yield stress, and strength.

[0033] As shown in Figure 9C, as the suture 921 is retracted, the outer material 943 of the polymer body 939 begins to bunch. As the suture 921 is further retracted toward the target tissue 922, the outer material 943 begins to gather in bunches along the surface 931 of the target tissue 922, as shown in Figure 9D. The interface 933 between the outer material 943 and the target tissue 922 generally has a larger area due to the expansion of the outer material 943. Thus, forces are better distributed at the interface 933, and the target tissue 922 is less likely to tear.

[0034] 10A-10C, a suture 1021 according to an embodiment of the present invention will be described. As shown, the suture 1021 includes a core 1047 surrounded by a sheath 1049. The portion of the core 1047 extending outside the sheath 1049 corresponds to the distal end 1053 of the suture 1021. In some embodiments, the sheath 1049 is radially expandable from the core 1047. Additionally, the sheath 1049 can move independently of the core 1047, allowing the sheath to expand, as shown in FIG. 10C. In this embodiment, the sheath 1049 is a continuous or sheet-like covering that bulges and buckles as the core 1047 expands and retracts, forming a solid, plug-like interface where the suture 1021 encounters the target tissue (not shown). In some embodiments, the sheath 1049 is concentrically disposed about the core 1047.

[0035] 11A-11B, the sheath 1149 of the suture 1121 includes multiple flexible strands. As shown, when the core 1147 of the suture 1121 is retracted, the flexible strands bulge and expand to form a mesh-like network with an increased surface area. In some embodiments, the sheath 1149 is arranged concentrically around the core 1147.

[0036] 12A-12B, the use of a sprayable adhesive 128 applied to an area of ​​target tissue 1222 in accordance with an embodiment of the present invention will be described in more detail. As shown, the sprayable adhesive 1280 is delivered through the endoscope 1214. The sprayable adhesive 1280 is applied to the target tissue 1222 at each interface 1233 where the suture 1221 and needle 1220 penetrate the target tissue 1222. This makes the interfaces 1233 less likely to tear under the tension of the suture 1221.

[0037] In use, a physician may perform an endoscopic procedure. The physician retracts the device occupying the working channel (e.g., a visualization device) and advances the needle or catheter 1281. Once this element reaches the working channel, a syringe (not shown) containing, for example, a medical-grade silicone-based spray adhesive is coupled to the proximal end of the catheter 1281 (e.g., via a Luer connector). The syringe is actuated, causing the sprayable adhesive 1280 to be expelled from the distal end of the endoscope 1214. As shown in FIG. 12B , as the sprayable adhesive hardens, the surfaces of the target tissue 1222 contacted by the cinch 1282 and needle 1220 harden and prevent expansion, thereby preventing the cinch 1282 and / or needle 1220 from passing through the hole in the target tissue 1222 at their respective interfaces 1233.

[0038] In the non-limiting embodiment of FIGS. 13A-13C , a curable adhesive 1380 (e.g., moisture or UV curable) can be applied to the target tissue 1322 at each end of the suture 1321 to distribute applied forces across the interface 1333 between the target tissue 1322 and the suture 1321. The flexible nature of the curable adhesive 1380 before curing can facilitate passage of the curable adhesive 1380 through the working channel of the endoscope 1314 and application to the target tissue 1322. Furthermore, the curable adhesive 1380 can allow the surgeon to better customize the final shape of the curable adhesive 1380 based on the surgical requirements, the location of the wound, his / her preferences, etc. For example, as shown in FIGS. 13B-13C , the curable adhesive 1380 is fitted within one or more cylindrical washers 1385, each having a central opening 1387. As a result, suture 1321 (FIG. 13C) passes through central opening 1387. Additionally, the use of hardenable adhesive 1380 also gives the surgeon the freedom to apply additional adhesive at various points in the procedure, for example, to improve force distribution as needed before or after suturing. In some embodiments, as shown in FIG. 13C, needle 1320 remains on hardenable adhesive 1380 after suturing. To improve visibility, in alternative embodiments, hardenable adhesive 1380 may be colored.

[0039] 14A-14C, one or more tubular tissue supports (e.g., washers) 1440 can be used on either side of the target tissue 1422. As shown, the tubular tissue support 1440 includes a slot 1489 through which the suture 1421 is threaded, allowing the tubular tissue support 1440 to be positioned anywhere along the suture 1421 after the suture 1421 has been threaded through the target tissue 1422. In some embodiments, after the suture 1421 has been placed and before the suture 1421 is tightened, the tubular tissue support 1440 can be delivered through an endoscope and manipulated into place using a grasper or similar device to protect the target tissue 1422.

[0040] 15, a tissue support in the form of one or more resilient elements, or spring-loaded wires, will be described. As shown, a wire 1590 is deployed from an endoscope 1514 onto the suture 1521 as the needle 1520 and suture 1521 pass through the target tissue 1522. In the non-limiting embodiment shown, the wire 1590 is a metallic spring-loaded wire with shape memory that is pre-loaded into a delivery catheter of the endoscope 1514. As the wire 1590 advances beyond the distal tip of the endoscope 1514, the wire 1590 begins to curl. As the wire 1590 begins to curl, it forms hooks 1592 that can engage the suture 1521 between the cinch 1591 and the target tissue 1522 and / or between the needle 1520 and the target tissue 1522.

[0041] Once the suture 1521 is captured by the hook 1592, the remainder of the wire 1590 is fed from the endoscope 1514. The wire 1590 continues to curl until the proximal end is ejected. The use of the wire 1590 allows for a low profile during delivery and, once deployed, prevents pull-out by allowing a large solid surface area for the cinch 1591 and needle 1520 to contact. In a non-limiting embodiment, the wire 1590 is formed from steel, nitinol, or any other material with a high spring constant. In another embodiment, the wire 1590 can also take the form of a ribbon, which can increase the surface area of ​​contact between the wire 1590 and the cinch 1591 and needle 1520.

[0042] Alternatively, wire 1590 is a bistable spring that is straight in one direction and curved in another. Wire 1590 is advanced until it is positioned between cinch 1591 and needle 1520. Once properly positioned, the spring is shifted in a second direction, causing the spring to curve in a coil or helical direction.

[0043] 16, a method 1600 according to an embodiment of the present invention will be described in more detail. In block 1601, the method includes passing a needle and suture of a tissue suturing device through target tissue, the tissue suturing device extending from the distal end of an endoscope. In some embodiments, multiple tissue supports are housed within a deployment device, with a first tissue support exposed within the suture cavity. In some embodiments, the deployment device is a cartridge or collar. In some embodiments, a cover extends across the deployment device, the cover including an opening to allow needle access to the multiple tissue supports. In some embodiments, the tissue support includes one or more of a flexible washer, an adhesive, a pledget, and an elastic or spring-loaded wire.

[0044] At block 1603, the method 1600 includes deploying a first tissue support from the tissue suturing device to a position along a first portion of the target tissue. In some embodiments, the first tissue support is engaged by a needle within the suture cavity to release the first tissue support from the deployment device. At block 1605, the method 1605 includes deploying a second tissue support from the tissue suturing device to a position along a second portion of the target tissue, wherein tightening the suture approximates the first and second tissue supports.

[0045] Although exemplary method 1600 is described as a series of acts or events, the present invention is not limited by the illustrated order of such acts or events, unless otherwise specified. For example, some acts may occur in a different order and / or simultaneously apart from those illustrated and / or described herein in accordance with the present invention. Moreover, not all illustrated acts or events are required to implement a methodology in accordance with the present invention. Furthermore, method 1600 may be implemented in connection with the formation and / or processing of structures illustrated and described herein, as well as in connection with other structures not illustrated.

[0046] Some embodiments are described using the terms "coupled" and "connected," along with their derivatives. These terms are not intended as synonyms for each other. For example, some embodiments are described using the terms "connected" and / or "coupled" to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "coupled" can also mean that two or more elements are not in direct contact with each other, but yet still cooperate or interact with each other.

[0047] 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. As used herein, the terms "comprises" and / or "comprising" or "includes" and / or "including" specify the presence of stated features, regions, step 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 thereof.

[0048] Furthermore, the terms "substantially" or "nearly," as well as "generally" or "approximately," can be used interchangeably in some embodiments and can be described using any relative measure acceptable to one of ordinary skill in the art. For example, these terms can serve as a comparison to a reference parameter and indicate a deviation that provides a desired function. Without limitation, deviations from the reference parameter can be, for example, less than 1%, less than 3%, less than 5%, less than 10%, less than 15%, less than 20%, etc.

[0049] Although specific embodiments have been illustrated and described herein, it should be understood that any configuration calculated to accomplish the same purpose may be substituted for the specific embodiment shown. The present invention is intended to cover any and all adaptations or variations of the various embodiments. It should be understood that the above description is made in an illustrative manner, not a limiting one. Upon reviewing the above description, one skilled in the art will be able to realize combinations of the above embodiments and other embodiments not specifically described herein. Thus, the scope of the various embodiments includes any other applications in which the above compositions, structures, and methods are used.

[0050] Although the subject matter has been described in language specific to structural elements 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 elements or acts described above. Rather, the specific elements and acts are disclosed as exemplary forms of implementing the claims. The technical ideas included in the present disclosure are described below. (Appendix 1) A tissue suturing device for use with an endoscope, the tissue suturing device being connectable to a distal end of the endoscope and comprising a plurality of tissue supports, each of the plurality of tissue supports being positionable against target tissue, and one or more of the plurality of tissue supports receiving a suture during deployment. (Appendix 2) 10. The tissue suturing device of claim 1, further comprising a deployment device, wherein the plurality of tissue supports are contained within the deployment device prior to deployment. (Appendix 3) 3. The tissue suturing device of claim 1 or 2, further comprising a needle that engages with a tissue support of the plurality of tissue supports to deploy the tissue support. (Appendix 4) 4. The tissue suturing device of any one of claims 1 to 3, further comprising a collar extending from a fixed end of the tissue suturing device, the collar defining a collar opening that aligns with a working channel of the endoscope, and the plurality of tissue supports extending around an outer periphery of the collar prior to deployment. (Appendix 5) a housing containing the plurality of tissue supports; a cover extending across the housing, the cover including openings allowing the needles attached to the sutures to access the plurality of tissue supports; 5. The tissue suturing device of claim 3 or 4, comprising: (Appendix 6) 6. The tissue suturing device of any one of claims 2 to 5, wherein the deployment device comprises an internal channel and a biasing device for biasing the plurality of tissue supports within the internal channel, the plurality of tissue supports being disposed end-to-end within the internal channel. (Appendix 7) 7. The tissue suturing device of any one of claims 2 to 6, wherein the deployment device includes a mandrel defining a central channel, and wherein each of the plurality of tissue supports is arranged concentrically about the mandrel. (Appendix 8) The suture is The core and and a sheath, the sheath operable to radially deploy from the core at a site adjacent the target tissue. (Appendix 9) 9. The tissue suturing device of claim 8, wherein the sheath comprises a plurality of flexible strands. (Appendix 10) 10. The tissue suturing device of any one of claims 1-9, wherein the plurality of tissue supports comprises one or more of flexible washers, sprayable adhesives, pledgets, and spring-loaded wires. (Appendix 11) a deployment device; a plurality of tissue supports deployable from the deployment device to a target tissue, the plurality of tissue supports including a central opening for receiving a suture during deployment; 1. A tissue suturing device comprising: (Appendix 12) a fixed end fixed to the distal end of the endoscope; 12. The tissue suturing device of claim 11, further comprising a free end opposite the fixed end, wherein the deployment device is coupled to one of the fixed end and the free end. (Appendix 13) 13. The tissue suturing device of claim 11 or 12, wherein the deployment device comprises a collar extending from the fixed end, the collar defining a collar opening that aligns with a working channel of the endoscope, and wherein each of the plurality of tissue supports extends around the outer periphery of the collar prior to deployment. (Appendix 14) The deployment device a housing enclosing the plurality of tissue supports; a cover extending across the housing, the cover including openings for needles attached to the sutures to access the plurality of tissue supports; 14. The tissue suturing device according to any one of claims 11 to 13, comprising: (Appendix 15) 15. The tissue suturing device of claim 14, wherein the housing comprises an internal channel and a biasing device for biasing the plurality of tissue supports within the internal channel, the plurality of tissue supports being arranged end-to-end within the internal channel.

Claims

1. 1. A tissue suturing device for use with an endoscope, comprising: a tissue suturing device extending from the distal end of the endoscope, the tissue suturing device having a fixed end fixed to the distal end of the endoscope and a free end opposite the fixed end; a housing coupled to the free end, the housing having an internal channel for accommodating a plurality of tissue supports, the housing further comprising a biasing device for biasing the plurality of tissue supports within the internal channel; each of the plurality of tissue supports is positionable at a target tissue, and one or more of the plurality of tissue supports receives a suture during deployment; The internal channel forms a suture cavity, the biasing device biases one of the multiple tissue supports toward the suture cavity, and when the tissue suturing device passes a needle inserted into the suture cavity back and forth between the fixed end and the free end along the longitudinal axis, the needle pierces the one of the multiple tissue supports, exits the suture cavity, and tensions the pierced one of the multiple tissue supports as it passes back and forth between the fixed end and the free end along the longitudinal axis, and the tensioned tissue support is deployed into the target tissue.

2. A tissue suturing device as described in claim 1, wherein the needle includes one or more sharp tips for puncturing the target tissue with each pass.

3. The tissue suturing device of claim 1 , further comprising a cover extending across the housing and including openings for access to the plurality of tissue supports by the needles.

4. The tissue suturing device of claim 3 , wherein the needle pulls the pierced one of the plurality of tissue supports through the opening.

5. The tissue suturing device according to claim 3 or 4, wherein the cover comprises a membrane.

6. The tissue suturing device of claim 3 or 4, wherein the cover includes a plurality of slats extending across the frame of the housing.

7. The tissue suturing device according to any one of claims 1 to 6, wherein the plurality of tissue supports are flexible components that are solid from one end to the other.

8. 1. A tissue support deployment device for use with an endoscopic tissue suturing device, comprising: a cartridge connectable to a free end of the tissue suturing device, the tissue suturing device being connectable to a distal end of an endoscope; a housing having an internal channel and containing a plurality of tissue supports; a biasing device disposed within the housing for biasing the plurality of tissue supports within the internal channel; a cover extending across the housing and including an opening for needle access to the plurality of tissue supports; a cartridge comprising: each of the plurality of tissue supports is deployable to a target tissue, and one or more of the plurality of tissue supports receives a suture during deployment; The internal channel forms a suture cavity, the biasing device biases one of the plurality of tissue supports toward the suture cavity, and when the tissue suturing device passes the needle inserted into the suture cavity back and forth along the longitudinal axis between a fixed end of the tissue suturing device fixed to the distal end of the endoscope and the free end opposite the fixed end, the needle pierces the one of the plurality of tissue supports, and when the needle exits the suture cavity and passes back and forth along the longitudinal axis between the fixed end and the free end, the needle tensions the pierced one of the plurality of tissue supports, and the tensioned tissue support is deployed into the target tissue.

9. A tissue support deployment device as described in claim 8, wherein the needle includes one or more sharp tips for puncturing the target tissue with each pass.

10. The tissue support deployment device of claim 8 , wherein the needle pulls the pierced one of the plurality of tissue supports through the opening.

11. The tissue support deployment device of any one of claims 8 to 10, wherein the cover comprises a membrane.

12. A tissue support deployment device according to any one of claims 8 to 10, wherein the cover includes a plurality of slats extending across the frame of the housing.

13. The tissue support deployment device according to any one of claims 8 to 12, wherein the plurality of tissue supports are flexible components that are solid from one end to the other.

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