Cutting anchor strips for suturing

Abstract

The present invention includes a single, molded strip of suture anchors connected in a detachable manner, which can be preloaded with sutures and then implanted in a site of use within the body. Such a configuration eliminates the need to reload anchors when several anchors are required. Furthermore, such a molded strip of anchors can contain all different types of suture anchors or locking devices on the same single strip. The strip will typically be molded from plastic or metal, offering the additional advantage of being injection-molded into a single piece in a single process, which not only reduces the cost per anchor but also provides advantages in assembly.

Description

Technical Field

[0001] Cross - reference to Related Applications This patent application claims the priority of U.S. Patent Application Publication No. 18 / 121,949, filed on March 15, 2023, with the title SUTURING BREAKAWAY ANCHOR STRIP, and the entire content of that document is incorporated herein by reference.

[0002] Surgical suture anchors have conventionally been used one at a time, and most are supplied individually or in a multi - fire connection type. Those anchors can be made of stainless steel, titanium, non - absorbent plastic, absorbent plastic, or certain composites of plastic and ceramic.

Background Art

[0003] Techniques for improving trans - wall apposition as well as tissue and lumen apposition are necessary for various clinical applications. Tissue apposition can be performed by through - the - scope clips (TTSC), over - the - scope clips (OTSC), and endoscopic suturing (ES) systems. Those procedures lack precision, reliable trans - ductal suturing, and durable and strong lumen apposition, do not reliably achieve full - layer suturing, and do not consider the extra - luminal structure. Furthermore, they lack durability due to "cheese - wiring" of the suture through the tissue and are too complex to be widely adopted.

[0004] The use of transmural sutures includes gastroplasty for the treatment of associated comorbidities such as overweight / obesity and metabolic disorders; anastomosis reduction (e.g., reduction of the gastric pylorus and gastric pouch) for the treatment of weight gain and / or dumping syndrome after gastric bypass surgery; implantation of implants (e.g., self-expanding metal stents) into the luminal wall; closure of defects including the lamina propria (e.g., closure of fistulas / leakages after full-thickness resection of lesions in the lumen of the gastrointestinal tract); antireflux surgery; gastroabdominal fixation for sliding hiatal hernias; and widening of stenoses by anchoring to the edge of the stenosis with or without dilation.

[0005] Endoscopic ultrasound-guided lumen junctions include lumen-apposing metallic stents (LAMS) that improve anastomosis formation under EUS, for example, for use in gallbladder drainage, gastrointestinal anastomosis, and drainage of abdominal deposits. However, challenges remain, such as the gallbladder or small intestine being pushed out during LAMS catheter insertion, insufficient length of LAMS catheter being inserted into the gallbladder or small intestine, and the distal flange being deployed between the stomach and the gallbladder or small intestine.

[0006] With the rapid spread of flexible endoscopic tissue resection techniques, there is an increasing need for efficient, effective, durable, and safe methods to achieve robust and durable closures. Furthermore, endoscopic antireflux therapy and endoscopic bariatric therapy rely on endoscopic suturing, which must be strong and safe. Currently, there is no simple, safe, and reliable method for full-thickness suturing of the gastrointestinal (GI) tract. Current techniques such as Apollo® Overstitch claim to be full-thickness, but in practice, they often end up being either too shallow or too deep.

[0007] The technical difficulty and invasive nature of endoscopic surgical procedures are offset by the ability to suture and perform secure closure. Currently, there are no techniques that use imaging to ensure the transmural or full-thickness placement of sutures / fasteners / anchors. Since no sutures are effectively under direct visualization and the tactile sensation of the sutured tissue is unavailable, it cannot be said with certainty that full-thickness suturing is being performed. Through-the-scope suturing techniques that enable full-thickness suturing are not currently commercially available. Over-the-scope attachments present challenges in terms of operability and visibility in practical use.

[0008] Current techniques are limited by the size of the sutures required due to the needle size (e.g., 2-0), and concerns about subsequent bleeding due to the blood vessels not being within the endoscopic field of view during the suturing process. Current techniques are cumbersome for the average user, involve a steep learning curve, and are limited to one type of suture. Non-linear placement complicates suture management, and novice users may struggle with suture placement, leading to the sutures breaking, becoming tangled, or giving them the false impression that a secure closure is being achieved. [Overview of the project] [Means for solving the problem]

[0009] This disclosure includes through-the-scope (endoscopy or endoscopic ultrasound) endoscopes or endoscopic ultrasound (EUS) and non-EUS tissue anchoring / suturing systems that allow the user to observe full-thickness tissue penetration while each route avoids blood vessels and other organs / tissues, linear placement that allows for increased flexibility and maneuverability, point-to-point rigid anchors that are essentially T-fasteners, and the ability to perform transmural bonding. EUS may include endoscopic ultrasound, gastroscopy, colonoscopy, and standard endoscopes. These improvements result in: (i) enhanced safety by enabling full-thickness implantation while avoiding unintended blood vessels / organs / extravascular structures; (ii) increased adaptability and ease of use through the use of straight-line implantation mechanisms based on other existing technologies, such as fine needle aspiration (FNA); (iii) improved performance through the use of a more robust anchor design compatible with various suture materials; (iv) increased durability through verification of transmural implantation by ultrasound; and (v) improved flexibility for tissue lumen and transmural junctions, as well as fixation of objects (stents, catheters, delivery carriers (drug therapy), etc.) into the lumen.

[0010] Specific applications of EUS-guided suturing systems include EUS-guided tissue junctions (luminal and transmural), luminal junctions (i.e., EUS-guided tissue suturing), gastric restriction surgery, antireflux surgery, gastroabdominal fixation for sliding hiatal hernias, and perforation closure. Furthermore, transmural junctions can lead to EUS drainage for infectious deposits, cholecystitis, and obstructive jaundice.

[0011] This disclosure includes EUS-guided and non-EUS systems using existing platform and needle-based technologies. Needle-based anchor placement systems with linear operating mechanisms eliminate the challenges of suture management. Tissue anchors are placed through EUS-guided transwall needles. Anchors can be simple T-tags or three-pronged prong anchor designs (e.g., three-pronged devices). Anchors seat independently in the suture material and are then pulled in so that each fastener acts as a transwall anchor. A unique anchor-retaining wedge allows the suture and needle to move freely until the anchor is ready to be placed through the tissue, enabling the placement of multiple anchors in succession.

[0012] A suture anchor system comprising a subcutaneous needle, a plurality of detachable suture anchors, sutures connected to the plurality of detachable suture anchors, a pusher connected to the plurality of suture anchors, a drive hub, and a handle configured to enable manual operation of the suture anchor system is described herein. In certain embodiments, the subcutaneous needle is a hollow subcutaneous needle comprising an endoscope needle or an ultrasound endoscope needle. In some cases, the plurality of detachable suture anchors are configured to be positioned inside the hollow subcutaneous needle. In one example, the drive hub is configured to push the plurality of detachable suture anchors into the tissue of the subject. The connected pusher and the plurality of suture anchors can be manufactured as a monolithic unit, either by fused and detachable mechanical connections or as a monolithic system of pushers and anchors. Fabricating the pusher and suture anchor as a single assembly simplifies fabrication and improves control, precision, and the reloadability of the device during placement of each anchor. Specifically, the reloadability is significantly beneficial because it allows for the placement of several anchors and sutures during a single procedure by replacing the pusher / anchor components without removing the entire needle system.

[0013] The suturing system may consist of a subcutaneous needle housing an assembly of suture anchors. The proximal end of the suture assembly consists of multiple connected suture anchors. The distal end of the suture assembly consists of a pusher. The pusher and the multiple suture anchors can be fabricated monolithically as a unit structure.

[0014] In a preferred embodiment, a plurality of detachable suture anchors comprises at least a first suture anchor. In one embodiment, a plurality of detachable suture anchors, after insertion into the subject's tissue, comprises holes for sutures and grooves for suture knots, configured to separate the first suture anchor from the plurality of detachable suture anchors. In some examples, the suture anchor system is configured to insert the plurality of suture anchors into the subject's tissue as needed to suture an opening in the subject's tissue. In certain embodiments, the handle is configured to house a drive hub and a subcutaneous needle, and a ball plunger protruding from the handle to enable manual operation of the suture anchor system.

[0015] The Specified Method of Suturing an Opening in the Tissue of a Subject also includes providing the suture anchor system described in claim 1, inserting a subcutaneous needle loaded with a plurality of detachably assembled suture anchors into the subject's tissue to place a first anchor at a first suture anchor point in the subject's tissue, retracting the needle, moving the needle to a second suture anchor point, inserting a subcutaneous needle loaded with a plurality of detachably assembled suture anchors into the subject's tissue to place a second suture anchor at a second suture anchor point, repeatedly placing suture anchors as necessary, and tightening the suture. In some cases, placing the first anchor includes pushing the first anchor inward into the tissue being sutured, and separating the first anchor from the plurality of detachably assembled suture anchors when pushed inward into the tissue. In some embodiments, retracting the needle involves delivering the suture from inside the tissue to outside the tissue. In one example, moving the needle to a second suture anchor point involves determining a sufficient spacing of sutures for optimizing the treatment. Thus, placing the second suture anchor involves pushing the second suture anchor into the tissue and separating the second suture anchor from a plurality of suture anchors assembled to be detachable. In some examples, tightening the suture involves pulling the suture so that the suture anchor and the suture gather the tissue together to promote healing.

[0016] Optional exemplary embodiments include the following: A strip-shaped anchor with a cut-type notch. Molded, dissimilar strip-shaped anchors. A method for cutting or separating an anchor within a needle or lumen. A molded strip-shaped anchor with a locking cinch. A molded, strip-shaped anchor. A strip-shaped anchor manufactured as a single monolithic section. A method using anchors to oppose the lumens. A method of using anchors to reduce the volume of an organ (stomach). A method for fixing an object to the inner wall of a lumen. A method to induce weight loss and improvement of metabolic profile by reducing the volume of an organ (e.g., the stomach). A method for fixing the luminal wall. A method for attaching one structure to another structure, or one lumen to another lumen. A method of aligning the bile duct with the lumen of the gastrointestinal tract under the guidance of EUS.

[0017] The embodiments included in the present invention are defined by the claims, not by this summary. This summary is a general overview of various aspects of the present invention and introduces some of the concepts further described in the paragraphs describing embodiments for carrying out the invention below. This summary does not identify any important or essential features of the claimed subject matter, nor is it to be used alone to determine the scope of the claimed subject matter. The subject matter should be understood by referring to the appropriate parts of the entire specification, any or all of the drawings, and each claim. [Brief explanation of the drawing]

[0018] [Figure 1] This diagram schematically shows a single, molded strip-shaped anchor according to an exemplary embodiment. [Figure 1.1] This diagram schematically shows a single, molded strip-shaped anchor according to an exemplary embodiment. [Figure 1.2] This diagram schematically shows a single, molded strip-shaped anchor according to an exemplary embodiment. [Figure 1.3] This diagram schematically shows a single, molded strip-shaped anchor according to an exemplary embodiment. [Figure 1.4]A diagram schematically showing a single-formed strip-shaped anchor according to an exemplary embodiment. [Figure 2] A diagram schematically showing a side view of an anchor strip according to an exemplary embodiment. [Figure 3] A diagram schematically showing an anchor strip ready for implantation according to an exemplary embodiment. [Figure 3.1] A diagram schematically showing an anchor strip ready for implantation according to an exemplary embodiment. [Figure 3.2] A diagram schematically showing an anchor strip ready for implantation according to an exemplary embodiment. [Figure 4] A diagram schematically showing an implantation system according to an exemplary embodiment. [Figure 4.1] A diagram schematically showing an implantation system according to an exemplary embodiment. [Figure 4.2] A diagram schematically showing an implantation system according to an exemplary embodiment. [Figure 4.3] A diagram schematically showing an implantation system according to an exemplary embodiment. [Figure 5] A diagram schematically showing an anchor strip during implantation according to an exemplary embodiment. [Figure 5.1] A diagram schematically showing an anchor strip during implantation according to an exemplary embodiment. [Figure 6] A diagram schematically showing the arrangement of a plurality of anchor strips according to an exemplary embodiment. [Figure 6.1] A diagram schematically showing the arrangement of a plurality of anchor strips according to an exemplary embodiment. [Figure 7] A diagram schematically showing a cinch anchor according to an exemplary embodiment. [Figure 7.1] A diagram schematically showing a cinch anchor according to an exemplary embodiment. [Figure 8] A digital image showing an anchor strip in a needle according to an exemplary embodiment. [Figure 9]This is a digital image showing a drive hub according to an exemplary embodiment. [Figure 10] This is a digital image illustrating the implantation procedure according to an exemplary embodiment. [Figure 11] This is a digital image showing an anchor strip in a needle during implantation, according to an exemplary embodiment. [Figure 12] This is a digital image showing a drive hub in a state of installation, according to an exemplary embodiment. [Figure 13] This is a digital image showing an anchor strip implanted from a needle, according to an exemplary embodiment. [Figure 14] This is a digital image showing a drive hub in a state of installation, according to an exemplary embodiment. [Figure 15] This is a digital image showing a drive hub in a state of installation, according to an exemplary embodiment. [Figure 16] This figure schematically shows a top view of a needle according to an exemplary embodiment. [Figure 17] This figure schematically shows a perspective view of a needle according to an exemplary embodiment. [Figure 18] This figure schematically shows a side view of a needle according to an exemplary embodiment. [Figure 19] This figure schematically shows a side view of a restorative system according to an exemplary embodiment. [Figure 20] This diagram schematically shows a side view of the arrangement of the internal mechanism of the implantation system according to an exemplary embodiment. [Figure 21] This diagram schematically shows a top view of the arrangement of the internal mechanism of the implantation system according to an exemplary embodiment. [Figure 22] This figure schematically shows a side view of the drive hub and suture path according to an exemplary embodiment. [Figure 23] This figure schematically shows a side view of a drive hub according to an exemplary embodiment. [Figure 24] This figure schematically shows a top view of a drive hub according to an exemplary embodiment. [Figure 25] This figure schematically shows a side view of an anchor strip according to an exemplary embodiment. [Figure 26] This figure schematically shows a side view of an anchor strip according to an exemplary embodiment. [Figure 27] This figure schematically shows a side view of an anchor strip according to an exemplary embodiment. [Figure 28] This figure schematically shows a side view of a needle according to an exemplary embodiment. [Figure 29] This diagram schematically shows a plurality of optional anchors and corresponding needles according to an exemplary embodiment. [Figure 30] This diagram schematically shows multiple optional anchors according to an exemplary embodiment. [Figure 31] This figure schematically illustrates a transmural suturing method according to an exemplary embodiment. [Figure 32] This figure schematically illustrates a transmural suturing method according to an exemplary embodiment. [Figure 33] This diagram schematically shows an implantation system prepared for implantation according to an exemplary embodiment. [Figure 34] This diagram schematically illustrates an anchoring system for anchoring, according to an exemplary embodiment. [Modes for carrying out the invention]

[0019] The present invention includes a single, molded strip-shaped anchor (Figure 1) that is connected in a detachable manner from one another, and which can be preloaded with sutures and then implanted in a site of use within the body. Such a configuration eliminates the need to reload anchors when several anchors are needed. Furthermore, such a molded strip-shaped anchor can contain all different types of suture anchors or locking devices on the same single strip (see Figures 1.2 and 1.3). The strips and pushers are typically molded monolithically from plastic or metal, providing the additional advantage of being injection-molded into a single piece in a single process, which not only reduces the cost per assembly but also provides the advantage of ease of use.

[0020] The new design involves loading a single suture strand and knot, which are positioned at the distal end of the anchor strip (Figure 1.4). Such a preloaded anchor strip is then incorporated into the delivery needle, with the distal end of the anchor strip maintained behind the distal needle tip (Figure 2). To implant the first distal anchor, the needle is positioned through the tissue, advancing the anchor strip and thereby exposing one anchor segment to the outside of the needle (Figure 3). The first anchor segment is then broken and separated from the anchor strip by pulling the proximal end of the suture (Figure 4), so that the segment is toggled in or behind the tissue (Figure 5) and locked in place. The needle is then repositioned to the next position, and the procedure is repeated as many times as possible with the anchor strip (Figure 6). The new design includes three anchors formed on a single strip; however, any number of anchors can be formed together in this manner.

[0021] When the final anchor segment is reached, it can be placed using the same method. However, after it is placed, the suture is pulled taut, forming a "purse string" closure of all the anchors placed up to that point. At that point, a locking scinch anchor device can be used to hold the suture and lock it in place. Alternatively, the final anchor within the strip anchor can house a characteristic locking scinch anchor (Figure 7), which locks the suture when it is pulled taut. The suture can then be cut by another instrument. Such a locking scinch for the final anchor is achieved by utilizing a "v" shape for locking in the final proximal anchor segment (Figure 7). When the suture is pulled taut into the V-shaped groove, the "v" shape reinforces the lock of the suture.

[0022] Another variation of the present invention described above involves having anchors that separate individually within the needle before exiting. This is achieved by placing a slight curve at the distal tip of the needle, so that as the anchor strip advances and is pushed into the curve, the most distal anchor breaks or separates just before exiting the needle tip. Once exiting the needle, the anchor toggles and locks freely within or behind the tissue. The remainder of the anchor in the formed strip remains connected until the procedure is repeated.

[0023] The anchor strip is advanced or pushed forward by a pusher (Figure 3). This pusher can be connected to the proximal end of the drive hub (Figure 4). The pusher 30 can be fabricated from a stainless steel tube, which allows the suture to be placed inside, and the suture 40 to pass continuously through the handle and drive hub. The pusher 30 can be fabricated as a single monolithic unit to which the suture anchor is connected, forming a single-unit assembly. The pusher and anchor can be monolithically molded from plastic, metal, or other biocompatible material, which offers the further advantage of being injection molded into a single piece. Alternatively, in some embodiments, the pusher 30 and the suture anchor strip can be fabricated separately and connected by adhesive, welding, or other suitable means of connection. The most proximal anchor of the suture anchor can be connected to the pusher 30 in a detachable manner.

[0024] Alternatively (Figure 3.2), the anchor strip may be connected to the pusher via a notch to connect to or interlock with the proximal end of the anchor strip.

[0025] The handle houses a drive hub (Figure 4) portion connected to the proximal end of the pusher, so that when the drive hub is pushed forward, the anchor strip advances. The pusher's hub has detents (detents, stoppers, claws) that allow the hub to stop in place on the handle. These detents engage with a ball plunger mounted on the handle. Furthermore, the distance between the detents is equal to the length of the anchor. This allows each anchor to advance by a set amount until it reaches the final anchor. This is also indicated by the numbers on an indicator that show the number of the anchor before it advances.

[0026] Figures 1 to 1.4 are a series of diagrams showing an anchor strip with a total of three anchors connected to each other, according to the present invention.

[0027] Figure 1 shows an isometric view of the anchor strip 1 with the sutures 40 attached. A key feature of the present invention is that the anchor strip 1 and pusher 30 can be manufactured as a single piece, typically by molding or 3D printing. Advantages of a single piece include cost savings due to molding in one piece, ease of use and cost savings in terms of anchor control and guidance, assembly, and design simplicity that does not require additional design features to hold the anchor in the correct position.

[0028] Figure 1.1 shows a side view of the anchor strip 1, including three anchors 2, 3, and 4 and a holder 5, all connected by a notch 8. Anchor 2 is the first anchor, followed by the second anchors 3 and 4.

[0029] Figure 1.2 shows a top view of anchor strip 1 having suture holes 6 and suture knot grooves 7, the grooves 7 having suture holes 16 where the knot is placed. Suture grooves 9 are also shown. Knot grooves 7 are larger than suture slots 9 to accommodate a larger size associated with the knot.

[0030] Figure 1.3 shows a bottom view of the anchor strip 1. The pusher 30 pushes the entire anchor strip 1 through the needle tube, bringing it into or behind the tissue. A groove 11 for the suture is also shown.

[0031] Figure 1.4 shows a cross-sectional view of an anchor strip 1 and a suture 40 passing through a through-hole 16, having a suture knot 41. The suture 40 is passed through or woven into the entire anchor strip 1 to sew through the suture holes 6 and suture grooves 9 and 11. Another important feature of the present invention is the slots 9 and 11 for the suture 40, which are offset from each other to allow for a larger cross-section 19. If the suture 40 were positioned linearly through the anchor strip 1, the cross-section 19 would be approximately half the thickness, potentially leading to malfunction when the suture 40 is pulled tightly after implantation. Malfunction occurs when the suture tears or rips the cross-section.

[0032] In previous toggle-type devices and conventional designs, the suture was positioned linearly through the anchor, resulting in a smaller cross-section for the suture to slide after placement. Typical toggle-type devices were manufactured by drilling holes in a tube or rod. This cross-section is necessary for the suture 40 to slide over and remain on the anchor, as seen in Figure 6.1, and is particularly necessary for anchors 3 and 4 as it requires the suture 40 to slide through the device.

[0033] Figure 2 shows a side view of the anchor strip 1 loaded onto a split needle 50, which has penetrated the tissue 55 and is ready for delivery. Yet another important feature of the present invention is that the user has control over all anchors 2, 3, and 4 by notches 8, which are rigid connections between each anchor. Such control is necessary for guiding each anchor so that each anchor is properly toggled in the upright position and the suture can freely exit the anchor slot 9. If the guidance is not in the upright position and the suture cannot freely exit the slot, the anchor will not be properly toggled, and the device will be pulled out of the tissue 55.

[0034] Another control characteristic is the linear motion within the needle. If the anchor were not connected to a drive device, it would detach from the needle and enter the body. Additional design features, including some form of detent to the needle, are typically required to prevent such detachment.

[0035] It should be noted that the needle 50 can also be placed into the tissue 55 from the central portion, rather than through the tissue 55.

[0036] Figures 3 to 3.2 show the anchor strip advanced and ready for placement. Alternative connections or engagements with the pusher tube are also shown.

[0037] Figure 3 shows the anchor strip 1 advanced beyond the needle 50, with the anchor 2 protruding beyond the needle tip 56.

[0038] Figure 3.1 shows the anchor strip 1, with the anchor 2 advancing over the split needle 50 and needle tip 56 by the pusher 30. The pusher 30 is connected to the anchor strip 1 as a single monolithic unit at its distal end. Furthermore, the pusher 30 is connected to the drive hub 70 at its proximal end.

[0039] Figure 3.2 shows an alternative embodiment in which the anchor strip 1 is connected to the pusher 30 via a notch 60 and can connect to or engage with the proximal end of the anchor 4.

[0040] Figures 4 to 4.3 show the handle, drive hub, and ball plunger.

[0041] Figure 4 shows the handle 80 with the drive hub 70 and the proximal end of the suture 40. The detent 71 is also shown.

[0042] Figure 4.1 shows the entire device.

[0043] Figure 4.2 shows a hidden diagram assembly having a ball detent 72 that engages with detent 71. There are a total of four detents. It also shows a pusher 30 connected to a drive hub 70, extending through a handle 80 and a needle 50.

[0044] Figures 4.2 and 4.3 show indicators 73 on the drive hub 70. The numbers on these indicators correspond to four detents. When indicator "0" is shown, this relates to the first or most distal detent 75 engaged with the ball plunger 72, with anchor 2 behind the needle tip 56 as shown in Figure 2. Indicator "1" relates to the second detent 76, where anchor 2 is ready for implantation and protrudes beyond the needle tip 56 as shown in Figure 3. At the position of indicator "1", "0" is no longer visible. Anchor 2 is the first anchor ready for implantation and corresponds to indicator "1" as the first anchor for implantation. Indicator "2" relates to the next detent 77, and the second anchor for which anchor 3 will be placed, where anchor 3 protrudes beyond the needle tip 56 at the same earlier location as anchor 2. The numbers on each successive indicator advance the next anchor ready for implantation.

[0045] Figures 5 to 5.1 show the anchor 2 that has been placed in place.

[0046] Figure 5 shows the first anchor 2 separated from the anchor strip 1 and behind the tissue 55. The first anchor 2 is separated by a notch 8, advanced by a pusher 30, and then toggled when the suture 40 is pulled. The suture 40 allows connection between the first anchor 2 and the anchor strip, which is now shortened, and which now consists of two anchors (anchors 3 and 4). The suture 40 is secured to the first anchor 2 by a knot 41 and cannot slide. Yet another important feature of the present invention is the cut tab 8, which allows for controlled separation of the anchor. Such controlled separation when the suture is pulled is important for reversing or toggling the anchor. Current toggle anchors do not reverse without variation, especially in central-type environments, resulting in the anchor device being pulled out.

[0047] Figure 5.1 shows the first anchor 2, which is toggled in place behind the tissue 55. This is achieved by removing the needle 50 from the tissue 55 and pulling the suture 40 to lock it in place behind the tissue 55.

[0048] Figures 6 to 6.1 show some examples of anchor placements.

[0049] Figure 6 shows anchor 2 delivered, toggled, and locked behind tissue 55, while anchor 3 is delivered, toggled, and ready to be locked. After the needle 50 is withdrawn and anchor 3 is locked behind tissue 55, the suture 40, which slides freely within anchor 3, can be pulled taut, thereby tightening the space between the anchors.

[0050] Figure 6.1 shows anchors 2, 3, and 4 placed behind tissue 55. With the suture 40 sliding freely within anchors 3 and 4, the free section of the suture 40 can be pulled taut. After tensioning, a scintillating anchor similar to that of an Apollo® type scintillating device (Apollo Endo-surgery, Austin, Texas, USA) can be used on the suture 40 in area 42.

[0051] Figure 7 shows a scintillator anchor 4a that replaces anchor 4. A V-shaped groove 90 is shown for sutures (not shown) to bite into. This scintillator anchor replaces a known Apollo® type device and is positioned distal to the tissue 55, as shown in the arrangement of anchor 4. The sutures 40 are then cut in region 42 using a suture cutting device.

[0052] Figure 7.1 shows a cinch anchor 4a that replaces anchor 4. V-grooves 90 and 91 for sutures (not shown) to bite into are shown.

[0053] In alternative embodiments of this disclosure, a currently available forward-line-of-sight array echo endoscope is inserted into the patient in a conventional and known manner. A position is selected for the placement of the first full-thickness anchor. Endoscopic ultrasound is used to identify whether there are any major blood vessels or adjacent structures, and if so, the scope can be adjusted accordingly.

[0054] EUS allows users to observe full-thickness penetrations where each pathway avoids blood vessels and other organs, and linear placement enhances flexibility and maneuverability. The anchors are essentially T-fasteners or similar, providing stronger anchoring at point-to-point. Devices that enable stronger use no longer limit the choice of suture materials. Transwall junctions, which were never previously possible, can now be performed by users under EUS guidance.

[0055] Needle 50 is loaded through the working channel of the ultrasound endoscope and locked in place at the biopsy valve site using a Luer lock mechanism, as is standard for all EUS needles. The needle is preloaded with a first tissue anchor, which is positioned behind the retaining wedge at the tip of the needle. The suture extends through the center of the needle and exits at the rear end of the handle. Furthermore, an open-design needle stylet is positioned behind the tissue anchor and alongside the suture, so that pushing the stylet downwards effectively pushes the anchor out of the needle.

[0056] Figure 8 is a digital image (photograph) showing an anchor 4 protruding from a needle 50. A suture thread 40 is loaded into the anchor 4. The anchor 4 includes a V-shaped groove 90 into which the suture thread 40 is attached.

[0057] Figure 9 is a digital image of the drive hub 70 and indicator 73. The needle 50 protrudes from the handle 80.

[0058] Figures 10 to 15 are digital images illustrating the implantation procedure. Figure 10 shows the anchor strip 1 attached to the needle 50, ready for insertion into the subject. Figure 11 shows the anchor 2 separated from the anchor strip 1. The anchor 2 is guided into the subject's tissue. Figure 12 shows the action used on the drive hub 70 for suturing. Once the anchor 2 is implanted, the device's handle 80 is pulled away from the subject, and the needle 50 is removed from the subject's tissue. The pulling force is always insufficient to remove the anchor 2 from the subject. Figure 13 shows the anchor 2 separated from the needle 50 and the anchor strip 1 with the suture 40 still attached. In actual implantation, the anchor 2 remains in the subject's tissue, anchoring the suture 40. Next, the device is moved to the next anchor position, the needle 50 is inserted into the tissue at that next anchor position, and the drive hub 70 advances to the next indicator 73. Figure 15 shows that the implantation procedure is repeated as needed until the suturing process is completed.

[0059] After the placement of the first anchor, the needle is withdrawn from the site where the first anchor was placed, and the ultrasound endoscope is retracted. At this time, the suture wire continues to extend through the center of the needle and emerges from the tip. The second anchor (which can also be preloaded) is loaded by pulling out the stylet, passing the anchor over the suture, and using the stylet to push the anchor towards the tip of the needle. The anchor automatically stops in the retaining wedge, which allows the scope and suture to move independently of the needle and anchor.

[0060] Next, a second site for anchor insertion is selected, and the above steps are repeated. The second anchor is placed transwall. This is repeated until a sufficient number of anchors are placed transwall to ensure proper tissue ligation when tightened. Tightening is performed by withdrawing the needle from the endoscopic channel and extending the scintillator to cover the suture. Alternatively, a removable internal needle design allows for the removal of the internal stylet while maintaining the needle sheath and handle in place. The scintillator is pressed against the tissue, and the suture is pulled against the scintillator to bring all the tissue anchors together. The suture and anchors move independently of each other until tightly tightened. The procedure is repeated using a new first anchor, and then using a second tissue anchor and a second scintillator, for a second consecutive transwall application.

[0061] There are a first tissue anchor and a second anchor. The first anchor is used for the first transmural pathway. The first anchor differs from the other in that it is fixed to the suture. In the second anchor, the suture passes freely through the anchor when the user pulls the suture tight. Along with the final scinch, the first anchor is crucial for pulling all intervening tissue together. The anchor and / or anchor strip can be a simple rod-shaped design, with each anchor moving hinged when transmural, acting as a T-tag. Alternatively, one can consider a more complex design of molded nitinol such that the rear half forms a Y-shape when the anchor is pushed out of the needle. The suture is bonded to its anchor, unlike in the case of the second anchor where the anchor moves freely on the suture. The suture is attached to the anchor at an intermediate point, so that the pressure is evenly distributed when pulled tight.

[0062] The second anchor differs from the others in that this device allows for the placement of several such anchors, thereby joining several points in the tissue. They are made of the same material and dimensions as the first anchors, but are shaped so that the suture passes through the center at the midpoint. This allows the anchor to move hinged, and when it is pushed through the tissue wall, the suture cannot be pulled out because of the anchor. A simple design like the one in A can be considered, but more precise designs are also possible. One such design is a tightly wound coil that is pushed through the needle when placed. When the needle and suture are pulled back, the length of the coil prevents it from being pulled out, and instead it "collects" to form a knot. This particular design makes placement easier when the position of the scope and needle increases resistance due to curvature and bending.

[0063] Figure 16 schematically shows the endoscopic needle 50. The needle tip 56 is tapered, configured to accommodate the anchor strip 1 before placement. Figure 17 schematically shows a perspective view of the needle 50, clearly showing the tapered tip 56. The taper facilitates insertion into the subject's tissue. Figure 18 schematically shows a side view of the needle 50, further showing the tapered tip 56.

[0064] Figures 19 and 20 show hidden-line side view assemblies of optional device structures. Figures 19 and 20 schematically show a drive hub 70 engaged with a handle 80. The handle 80 includes a channel for guiding the needle 50. Figure 21 shows a hidden-line top view assembly of optional device structures, including the drive hub 70 engaged with the handle 80 and the channel for guiding the needle 50.

[0065] Figure 22 schematically shows a hidden line side view of the drive hub 70. Figure 22 shows in detail the channel, detent, indicator 73, and ball plunger 72 for the suture 40. The arrows indicate the direction in which the ball plunger 72 is pushed in to secure the suture 40. Figure 23 shows a side view of the drive hub 70, and Figure 24 schematically shows a top view of the drive hub 70.

[0066] Figure 25 schematically shows a side view of the anchor strip 1, which includes three anchors 2, 3, and 4 and a holder 5, all connected by notches 8. Anchor 2 is the first anchor 2, followed by the second anchors 3 and 4. Figure 26 schematically shows a top view of the anchor strip 1, which has holes 6 for sutures and grooves 7 for suture knots, where the groove 7 has holes 16 for sutures, and the holes 16 are where the knot is positioned. A groove 9 for sutures is also shown. The groove 7 for knots is larger than the suture slots 9 to accommodate a larger size associated with the knot. Figure 27 schematically shows a side contour view of the anchor strip 1.

[0067] Figure 28 schematically shows a needle 50 having an optional angled tapered design. The needle 50 is pushed into the ultrasound field, similar to standard fine-needle aspiration (FNA). The needle 50 is carefully pushed through the tissue wall under ultrasound guidance, and when the user confirms on ultrasound that the needle 50 is full-thickness, anchor 1 is placed as shown in Figure 14. When the space for placement is small, the needle is pushed through the wall to ensure transmural (penetrating / serous) penetration, then pulled back slightly to the edge of the tissue wall, and placed when the user simultaneously pulls the needle back.

[0068] In an alternative embodiment, when there is little or no separation distance between intraperitoneal structures, such as the gallbladder or liver adjacent to the stomach, the user can inject a solution / gel through the needle 50 to create space before inserting the T-tag. The technique may include inserting the needle to ensure sufficient passage through the serosa and then withdrawing the needle to the edge of the tissue. In this respect, the anchor is pushed out as the needle is withdrawn, thereby enabling "proper" placement when the separation distance or space between intraperitoneal structures is limited.

[0069] Figures 29 and 30 schematically show optional anchor and needle tip configurations. As shown in Figures 29 and 30, the needle tip can be adjusted to correspond to the desired anchor configuration. Optional anchor configurations may include expandable anchors, loop anchors, body-through anchors, helical anchors, Y-shaped anchors, and the like.

[0070] The anchor material can be varied depending on the application. The first and second anchors do not need to be made from the same material. Transwall anchors should be made from materials acceptable to the human body (i.e., stainless steel, nitinol, etc.). These can also be made from bioabsorbable materials. In most applications, the sutures are not meant to maintain tissue fusion for months. Instead, over time, scar formation and bodily healing progress, and the sutures become less noticeable. Polyglycolic acid (PGA) can be used to form anchors and suture wires. This means that even transwall anchors will be virtually absorbed over months, and therefore there are no long-term concerns.

[0071] Figures 31 and 32 schematically illustrate the suturing procedure described above. In particular, Figure 31 shows the insertion of the needle 50 in step (1), the placement of the first anchor 2, the subsequent suture thread 40, and the insertion of the second needle 50 in step (2). Figure 32 shows the complete suturing procedure with four anchors placed and linked by the suture thread 40. The suture thread 40 can be tightened by pulling it. When the suture thread 40 is tightened, the opening in the tissue is closed.

[0072] Figures 33 and 34 schematically show a needle anchor retaining mechanism that allows the anchor strip 1 and suture thread 40 to be loaded onto the needle 50. The anchor strip 1 is positioned behind a retaining wedge and held in place by the wedge. A drive hub (not shown) includes a stylet, which is configured to push the anchor strip over the retaining wedge and initiate the placement of the anchor 1. Finally, the needle 50 and stylet are hollow to allow the suture thread 40 to pass through.

[0073] The needle anchor retention mechanism ensures that the anchor is securely seated just in front of the needle tip. Without it, accidental premature placement or accidental dislodgement due to simple manipulation of the scope would occur. The wedge would succumb to the pressure from the push-in stylet as the anchor is being delivered. Having such a wedge mechanism allows the suture wire to extend from the center of the needle through each anchor being placed. This is important for placing several anchors in complex patterns.

[0074] Similarly, the push-in stylet allows the suture to extend to the center. The anchor is loaded and delivered to the distal tip of the needle by the push-in stylet. The suture wire extends throughout the needle and through the anchor. Other types of needles can be considered that allow several second anchors to be preloaded into the needle. Again in this situation, the wedge allows for the placement of a single anchor and the position for subsequent anchor placements to be selected.

[0075] The features of this disclosure include an EUS-based system using existing EUS platforms and EUS needle-based technologies that are easily accessible to users, and a needle-based anchor placement system with a linear operating mechanism that eliminates the challenges of suture management, with tissue anchors being placed via a needle in an EUS-guided transwall manner, and anchors being able to be designed as simple T-tags or trident anchors (e.g., trident devices). The tags or anchors can be made from nitinol or absorbable materials (e.g., PGA). Furthermore, the system design can provide users with a number of choices regarding suture materials (e.g., absorbable or non-absorbable, braided or unbraided, 0 or 2-0, etc.).

[0076] In alternative embodiments, the disclosure provides a solution relating to a T-shaped tag or similar anchor positioned serosal-side to an organ and penetrating or migrating into or laterally within another organ, for example, within the mediastinum. Because the T-shaped tag or anchor is linearly placed and under tension during placement, it does not produce effects from intersecting sutures. Even assuming tension on the sutures during application, it would still in practice penetrate or migrate inward.

[0077] The anchors rest independently on the suture wire and are then tightened at the end. All fasteners act as trans-wall anchors, and the cinch sits on the lumen side. The anchor-holding wedge allows the suture and needle to move freely until the anchor is ready to be implanted through the tissue. Thus, several anchors can be implanted consecutively on the same suture. This is a major innovation over previous prototypes and designs where two independent sutures and anchors had to be tightened together. Conventional designs could not accommodate more than two points of proximity. This solution can be expanded depending on the number of anchors implanted trans-wall.

Claims

1. In a suture anchoring system, Subcutaneous needle and An assembly of suture anchors, wherein the assembly has a proximal end and a distal end. The proximal end is equipped with a pusher. The distal end is equipped with a plurality of connected suture anchors. A suture anchor system comprising the pusher and the plurality of connected suture anchors, and the assembly, wherein the pusher and the plurality of connected suture anchors are manufactured monolithically as a unit structure.

2. The suture anchor system according to claim 1, wherein the plurality of suture anchors are connected in a detachable manner.

3. The suture anchor system according to claim 1, further comprising sutures connected to the plurality of suture anchors.

4. The suture anchor system according to claim 1, wherein the subcutaneous needle is a hollow subcutaneous needle equipped with an endoscope needle or an endoscopic ultrasound needle.

5. The suture anchor system according to claim 4, wherein the assembly of multiple suture anchors is configured to be positioned within the hollow subcutaneous needle.

6. The suture anchor system according to claim 1, wherein the plurality of suture anchors comprises at least a first suture anchor.

7. The suture anchor system according to claim 6, wherein, after being inserted into the tissue of a subject, the plurality of suture anchors are provided with holes for sutures and grooves for suture knots configured to separate the first suture anchor from the plurality of suture anchors.

8. The suture anchor system according to claim 7, wherein the suture anchor system is configured to insert the plurality of suture anchors into the subject's tissue as needed in order to suture an opening in the subject's tissue.

9. The suture anchoring system according to claim 1, wherein the handle is configured to house the pusher and the subcutaneous needle.

10. The suture anchor system according to claim 9, wherein a ball plunger protrudes from the handle, enabling manual operation of the suture anchor system.

11. In a method for suturing an opening in the physical tissue of a subject, the method is: To provide a suture anchoring system comprising a pusher and multiple suture anchors, To provide a suture anchor system in which the pusher and the plurality of suture anchors are manufactured monolithically as a unit structure, The first anchor is placed at the first suture anchor point in the subject's tissue by inserting a subcutaneous needle loaded with the plurality of suture anchors into the subject's tissue. Retracting the aforementioned needle, Moving the aforementioned needle to the second suture anchor point, By inserting the subcutaneous needle loaded with the plurality of suture anchors into the subject's tissue, a second suture anchor is placed at the second suture anchor point. If necessary, suture anchors will be repeatedly placed, To tighten the aforementioned suture thread and Methods that include...

12. The method according to claim 11, wherein the placement of the first anchor includes pushing the first anchor inward into the sutured tissue.

13. The method according to claim 12, wherein once the first anchor is pushed inward into the tissue, it separates from the plurality of suture anchors.

14. The method according to claim 11, wherein retracting the needle includes delivering the suture from inside the tissue to outside the tissue.

15. The method according to claim 11, wherein moving the needle to the second suture anchor point comprises determining a suture spacing sufficient for healing.

16. The method according to claim 11, wherein the placement of the second suture anchor includes pushing the second suture anchor into the tissue and separating the second suture anchor from the plurality of suture anchors.

17. The method according to claim 11, wherein the tightening of the suture includes pulling the suture so that the suture anchor and the suture gather the tissue together to promote healing.

18. In a suturing kit, Subcutaneous needle and Pusher and Equipped with multiple connected suture anchors, A suturing kit in which the pusher and the plurality of connected suture anchors are manufactured as a detachable single unit.

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