Fracturable anchoring strip for suturing

Abstract

The present invention comprises an anchor strip of a single molded suture anchor, the suture anchors being breakably connected to each other, the suture anchor strip being preloaded with a suture and then deployed at a site of use in the body. This configuration eliminates the need to reload the anchors when multiple anchors are needed. In addition, the molded anchor strip may include different variants of a suture anchor or a locking device in the same single strip. The anchor strip is typically molded from plastic or metal, and has the additional advantage of integral manufacturing in a one-shot injection molding manner, which not only saves the cost per anchor, but also provides the advantage in assembly.

Description

[0001] Cross-references to related applications

[0002] This patent application claims priority to U.S. Patent Application 18 / 121,949, filed March 15, 2023, entitled “SUTURING BREAKAWAY ANCHOR STRIP,” which is incorporated herein by reference in its entirety. Technical Field

[0003] Surgical suture anchors have historically been used individually, and are most often supplied individually or in sets of multiple anchors. These anchors can be made of stainless steel, titanium, non-absorbable plastics, absorbable plastics, or some mixture of plastics and ceramics. Background Technology

[0004] Improved techniques for transcavitary and luminal closure are necessary for a variety of clinical indications. Tissue closure can be achieved using trans-endoscopic clamping (TTSC), external endoscopic clamping (OTSC), and endoscopic suturing (ES) systems. These procedures lack precision, reliable transluminal suturing, and durable, stable luminal closure, and cannot reliably achieve full-thickness closure, nor do they consider extraluminal structures. Furthermore, these procedures are not durable enough and are too cumbersome to be widely adopted due to the "cheese-wiring" effect of sutures in the tissue.

[0005] Applications of transmural sutures include: gastrectomy for the treatment of overweight / obesity and its associated comorbidities (e.g., metabolic diseases); anastomotic reduction (e.g., gastric outlet and pouch reduction for the treatment of weight rebound and / or dumping syndrome after gastric bypass surgery); securing implants (e.g., self-expanding metal stents) to the luminal wall; closing defects involving the muscularis propria (e.g., fistula / leakage closure after full-thickness resection of lesions within the luminal digestive tract); antireflux surgery; gastric fixation for sliding hiatal hernias; and, with or without dilation, retracting the edges of the stenosis to dilate it.

[0006] Endoscopic ultrasound (EUS)-guided lumen anastomosis, including the lumen anastomosis stent (LAMS), improves EUS-guided anastomosis creation, for example, in gallbladder drainage, gastrointestinal anastomosis, and drainage of ascites. However, problems remain, such as the gallbladder or small intestine being pushed aside during LAMS deployment catheter insertion, insufficient length of the LAMS deployment catheter to be inserted into the gallbladder or small intestine, and the distal flange opening between the stomach and the gallbladder or small intestine.

[0007] Flexible endoscopic methods for tissue resection are rapidly evolving, which leads to an urgent need for robust and durable closure in an efficient, effective, durable, and safe manner. In addition, endoscopic anti-reflux therapies and endoscopic obesity therapies rely on endoscopic suturing, which must be strong and safe. There is currently no simple, safe, and reliable method for full-thickness suturing in the gastrointestinal (GI) tract. Prior art such as Overstitch, while claiming to enable full-thickness suturing, often does not achieve full-thickness or beyond in actual practice.

[0008] The technical difficulty and invasiveness of endoscopic surgery is mitigated by its ability to suture and provide secure closure. There is currently no way to use imaging means to guarantee transmural or full-thickness placement of sutures / fasteners / anchors. All suturing is actually performed blind, and there is no confirmation that full-thickness suturing is being reliably performed due to lack of tactile feedback of the tissue being sutured. There is currently no commercially available endoscopic channel suturing technology that allows for full-thickness plication suturing. Accessories outside of the endoscopic channel create operability and visualization issues in actual use.

[0009] Prior art is limited by suture size due to needle size (e.g., 2-0), and subsequent bleeding issues due to blood vessels not being in the endoscopic field of view during the suturing process. Prior art is cumbersome for the average user, requires new knowledge to be quickly acquired in a short time, and is limited to a single type of suture. Non-linear deployment makes suture management complex, and novice users suffer from improper suture placement: these sutures either break, or tangle, or create an illusion of secure closure. SUMMARY

[0010] The present disclosure includes: endoscopic or endoscopic ultrasound (EUS) and non-EUS guided tissue anchoring / stapling systems via endoscopic channels (endoscope or echoendoscope) that allow the user to visualize full layer tissue penetration at each pass to avoid blood vessels and other organs / tissues; linear deployment that allows for increased flexibility and maneuverability; an anchor that is essentially a T-shaped fastener that is robust on a point-to-point basis; and allows for transmural apposition. The EUS can include an ultrasound endoscope, gastroscope, colonoscope, standard endoscope, etc. These improvements provide: (i) enhanced safety by allowing full layer penetration and avoiding non-target blood vessels / organs / luminal extramural structures, (ii) adaptability and ease of use with a simple deployment mechanism based on other existing technologies (e.g., as with EUS fine needle aspiration needles (FNA)), (iii) improved performance with a more robust anchor design that supports multiple suture materials, (iv) increased durability with proven transmural deployment via ultrasound capability, and (v) increased flexibility that can be used for luminal apposition and transmural apposition of tissue and fixation of objects (stents, catheters, delivery vehicles (drugs), etc.) to lumens.

[0011] Specific applications of the EUS guided stapling system include: EUS guided tissue apposition (luminal and transmural), luminal apposition (i.e., EUS guided tissue stapling), gastric restriction procedures, anti-reflux procedures, gastric fixation for sliding hiatal hernias, and closure of perforations. In addition, transmural apposition can guide EUS drainage for infectious accumulations, cholecystitis, and obstructive jaundice.

[0012] The present disclosure includes: EUS and non-EUS guided systems using existing platforms and needle-based technologies; a needle-based anchor deployment system with a linear action mechanism that eliminates suture management issues; a tissue anchor that is deployed via a needle in an EUS guided transmural fashion. The anchor can be a simple T-shaped tag or a tri-pronged anchor design (e.g., a trident). The anchor can be independently sheathed over a suture material and then tightened at the end, with each fastener acting as a transmural anchor. The unique anchor securing wedge allows the suture and needle to move freely until the anchor is ready for deployment through tissue and allows multiple anchors to be deployed consecutively.

[0013] Described herein is a suture anchor system comprising a hypodermic needle, a breakably assembled plurality of suture anchors, a suture connected to the breakably assembled plurality of suture anchors, a pusher connected to the plurality of suture anchors, a drive hub, and a handle configured to allow manual operation of the suture anchor system. In certain embodiments, the hypodermic needle is a hollow hypodermic needle comprising an endoscopic needle or an endoscopic ultrasound needle. In some cases, the breakably assembled plurality of suture anchors is configured to be located inside the hollow hypodermic needle. In one example, the drive hub is configured to drive the breakably assembled plurality of suture anchors into a subject's tissue. The connected pusher and plurality of suture anchors can be manufactured as a monolithic single unit, either using a fused and breakable mechanical connection, or as a single body pusher and anchor system. Manufacturing the pusher and suture anchors as a single component can result in easier manufacturing, better control precision during deployment of each anchor, and repeatable loading of the device during a procedure. Specifically, repeatable loading is significantly beneficial since multiple anchors and sutures can be deployed during a single procedure by replacing the pusher / anchor component without removing the entire needle system.

[0014] The suture system can be comprised of a hypodermic needle containing a suture anchor assembly. The proximal end of the suture assembly is comprised of a plurality of connected suture anchors. The distal end of the suture assembly is comprised of a pusher. The pusher and plurality of suture anchors can be manufactured as a monolithic single unit.

[0015] In preferred embodiments, the breakably assembled plurality of suture anchors comprises at least a first suture anchor. In one embodiment, the breakably assembled plurality of suture anchors comprises a suture hole and a suture knot recess configured to separate the first suture anchor from the breakably assembled plurality of suture anchors after insertion into a subject's tissue. In some examples, the suture anchor system is configured to insert the plurality of suture anchors into a subject's tissue as needed to suture an opening in the subject's tissue. In certain embodiments, the handle is configured to house the drive hub and the hypodermic needle, and a ball tipped plunger protrudes from the handle allowing manual operation of the suture anchor system.

[0016] Also described herein is a method of suturing an opening in a subject's tissue, the method comprising: preparing a suture anchor system according to claim 1; deploying a first anchor into a first suture anchor point in the subject's tissue by inserting a hypodermic needle loaded with a fracturable assembly of a plurality of suture anchors into the subject's tissue; withdrawing the needle; moving the needle to a second suture anchor point; deploying a second suture anchor in the second suture anchor point by inserting the hypodermic needle loaded with the fracturable assembly of a plurality of suture anchors into the subject's tissue; repeating the deploying a suture anchor as needed; and cinching the suture. In some cases, deploying the first anchor comprises driving the first anchor into an inside of the tissue being sutured, and detaching the first anchor from the fracturable assembly of a plurality of suture anchors once the first anchor is driven into the inside of the tissue. In some embodiments, withdrawing the needle comprises guiding the suture from the inside of the tissue to the outside of the tissue. In one example, moving the needle to the second suture anchor point comprises determining a suture spacing sufficient to optimize healing. Thus, deploying the second suture anchor comprises driving the second suture anchor into the inside of the tissue, and detaching the second suture anchor from the fracturable assembly of a plurality of suture anchors. In some examples, cinching the suture comprises pulling the suture such that the suture anchors and the suture cause the tissue to come together thereby inducing healing.

[0017] Optional illustrative embodiments include:

[0018] Anchoring strips with fracturable notches.

[0019] Molded strips composed of different anchors.

[0020] Methods of fracturing or detaching anchors within a needle or lumen.

[0021] Molded anchoring strips with locking cinchers.

[0022] Molded anchoring strips.

[0023] Anchoring strips manufactured as a single integral piece.

[0024] Methods of using anchors to approximate lumens.

[0025] Methods of using anchors to reduce the volume of an organ (stomach).

[0026] Methods of securing objects to lumen walls.

[0027] Methods of inducing weight loss and metabolic improvement by reducing the volume of an organ (e.g., stomach).

[0028] Methods of securing lumen walls.

[0029] Methods of securing one structure to another structure or one lumen to another lumen.

[0030] Methods of anastomosing a biliary duct to a luminal gastrointestinal tract under EUS guidance.

[0031] The embodiments encompassed by the present application are defined by the claims, not by the description. The description is a high-level overview of the various aspects of the application and introduces some of the concepts that are further described in the detailed description section below. The summary is not intended to identify key or essential features of the claimed subject matter, nor is it meant to limit the scope of the claimed subject matter. The subject matter should be understood from the entire description of the application, with appropriate sections of the description, any or all drawings and the claims being consulted. BRIEF DESCRIPTION OF DRAWINGS

[0032] Figures 1 to 1.4 A single molded anchor strip according to illustrative embodiments is schematically shown.

[0033] Figure 2 A side view of an anchor strip according to illustrative embodiments is schematically shown.

[0034] Figures 3 to 3.2 An anchor strip ready for deployment according to illustrative embodiments is schematically shown.

[0035] Figures 4 to 4.3 A deployment system according to illustrative embodiments is schematically shown.

[0036] Figures 5 to 5.1 An anchor strip during deployment according to illustrative embodiments is schematically shown.

[0037] Figures 6 to 6.1 A plurality of anchor strips arrangement according to illustrative embodiments is schematically shown.

[0038] Figures 7 to 7.1 A cinching anchor according to illustrative embodiments is schematically shown.

[0039] Figure 8 A digital image showing an anchor strip within a needle according to illustrative embodiments.

[0040] Figure 9 A digital image showing a drive hub according to illustrative embodiments.

[0041] Figure 10 A digital image showing a deployment process according to illustrative embodiments.

[0042] Figure 11 A digital image showing an anchor strip within a needle during deployment according to illustrative embodiments.

[0043] Figure 12 is a digital image showing a drive hub during deployment according to an illustrative embodiment.

[0044] Figure 13 is a digital image showing an anchor strip deployed from a needle according to an illustrative embodiment.

[0045] Figure 14 is a digital image showing a drive hub during deployment according to an illustrative embodiment.

[0046] Figure 15 is a digital image showing a drive hub during deployment according to an illustrative embodiment.

[0047] Figure 16 schematically illustrates a top view of a needle according to an illustrative embodiment.

[0048] Figure 17 schematically illustrates a perspective view of a needle according to an illustrative embodiment.

[0049] Figure 18 schematically illustrates a side view of a needle according to an illustrative embodiment.

[0050] Figure 19 schematically illustrates a side view of a deployment system according to an illustrative embodiment.

[0051] Figure 20 schematically illustrates a side view of an internal mechanism arrangement of a deployment system according to an illustrative embodiment.

[0052] Figure 21 schematically illustrates a top view of an internal mechanism arrangement of a deployment system according to an illustrative embodiment.

[0053] Figure 22 schematically illustrates a side view of a drive hub and suture path according to an illustrative embodiment.

[0054] Figure 23 schematically illustrates a side view of a drive hub according to an illustrative embodiment.

[0055] Figure 24 schematically illustrates a top view of a drive hub according to an illustrative embodiment.

[0056] Figure 25 schematically illustrates a side view of an anchor strip according to an illustrative embodiment.

[0057] Figure 26 schematically illustrates a side view of an anchor strip according to an illustrative embodiment.

[0058] Figure 27 A side view of an anchor strip is schematically illustrated, according to an illustrative embodiment.

[0059] Figure 28 A side view of a needle is schematically illustrated, according to an illustrative embodiment.

[0060] Figure 29 A plurality of alternative anchors and corresponding needles are schematically illustrated, according to an illustrative embodiment.

[0061] Figure 30 A plurality of alternative anchors are schematically illustrated, according to an illustrative embodiment.

[0062] Figure 31 A transmural suturing method is schematically illustrated, according to an illustrative embodiment.

[0063] Figure 32 A transmural suturing method is schematically illustrated, according to an illustrative embodiment.

[0064] Figure 33 A deployment system ready for deployment is schematically illustrated, according to an illustrative embodiment.

[0065] Figure 34 A deployment system deploying an anchor is schematically illustrated, according to an illustrative embodiment. DETAILED DESCRIPTION

[0066] The present invention includes a single piece molded anchor strip ( Figure 1 ) with anchors that are frangibly connected to each other, which can be preloaded with sutures, and then deployed at the site of use in the body. This configuration eliminates the need to reload anchors when multiple anchors are required. In addition, the molded anchor strip can include different suture anchors or locking devices (see Figure 1.2 、 Figure 1.3 ) in the same single strip. The anchor strip and the pusher are typically integrally molded from plastic or metal, and have the additional advantage of being manufactured in one injection molding, which not only saves the cost of assembly each time, but also provides the advantage of ease of use.

[0067] The novel design will have a single strand of suture loaded and a knot ( Figure 1.4 ) placed at the distal tip of the anchor strip. The preloaded anchor strip is then assembled into a delivery needle ( Figure 2 ) with the distal tip of the anchor strip held behind the distal needle tip. To deploy the first distal anchor, the needle is placed through the tissue and the anchor strip is advanced so that one anchor segment is exposed outside the needle ( Figure 3 ). Then, by pulling the proximal end of the suture ( Figure 4), the first anchor segment will break and separate from the anchor strip, flipping it over ( Figure 5 ), locking into or behind the tissue. The needle is then repositioned to the next location and the process is repeated again ( Figure 6 ) as the anchor strip allows. This new design includes three anchors molded into a single strip. However, any number of anchors can be molded together in this fashion.

[0068] When the last anchor segment is reached, it can be deployed in the same manner. However, after this anchor segment is deployed, the suture is pulled tight, which causes all the previously deployed anchors to form a "purse string" like closure. At this point, a locking cinch anchor type device can be used to hold the suture and lock it in place. Alternatively, the last anchor in the anchor strip can contain a locking cinch type feature ( Figure 7 ) that locks the suture when pulled tight. The suture can then be cut with another instrument. The locking cinch of this last anchor is achieved by utilizing a "v" shaped lock in the final proximal anchor segment ( Figure 7 ). The more the suture is pulled into the v shaped groove, the more the "v" shape locks onto the suture.

[0069] Another variation of the above invention is to have the anchors individually separate within the needle before exiting the needle. This will be achieved by setting a slight bend in the distal tip of the needle so that when the anchor strip is pushed forward into the bend, the distal most anchor breaks or separates just before exiting the needle tip. Once the anchor exits the needle, it can freely flip over and lock into or behind the tissue. The remaining anchors in the molded strip remain connected until the process is repeated.

[0070] The anchor strip is advanced or driven by a pusher ( Figure 3 ). The pusher can be connected proximally to a drive hub ( Figure 4 ). The pusher 30 can be made of stainless steel tubing which allows the suture to be placed inside and the suture 40 can continue through the handle and drive hub. The pusher 30 can be manufactured as one integral unit with the attached suture anchors, creating a single piece unit assembly. The pusher and anchors can be integrally molded from plastic, metal or other biocompatible material and will provide the added advantage of being injection molded in one piece. Alternatively, in some embodiments, the pusher 30 and suture anchor strip can be manufactured separately and connected by adhesive, welding or other suitable means of connection. The proximal most anchor of the suture anchors is able to be frangibly connected to the pusher 30.

[0071] Alternatively ( Figure 3.2 ), the anchor strip can be connected to the pusher via a notch to connect or mate the proximal end of the anchor strip.

[0072] The handle contains a drive hub Figure 4 ) portion that is connected to the proximal end of the pusher such that when the drive hub is pushed forward, the anchoring strips are pushed with it. The pusher hub has stops that enable it to stop at predetermined positions in the handle. These stops cooperate with the ball head plunger that is assembled in the handle. Furthermore, the distance between the stops is equal to the length of the anchors. This will allow each anchor to be pushed a set amount until the last anchor is reached. This is also described by the indicator numbers that show the anchor number before the anchor is pushed.

[0073] Figures 1 to 1.4 is a series of illustrations of the anchoring strips showing a total of three anchors connected to each other according to the invention.

[0074] Figure 1 shows an isometric view of the anchoring strip 1 with suture 40 attached. A key feature of the invention is the ability to make the anchoring strip 1 and pusher 30 a single piece, which is typically achieved through molding or 3D printing. Advantages of the single piece construction include: cost savings from single piece molding; control and orientation of the anchors; ease of use and savings in assembly costs; and simplicity of design without the need for additional design features to orient and hold the anchors in place.

[0075] Figure 1.1 depicts a side view of the anchoring strip 1 that includes three anchors 2, 3, 4 and a retainer 5, all connected by notches 8. Anchor 2 is the first anchor 2 to start, followed by second anchors 3 and 4.

[0076] Figure 1.2 shows a top view of the anchoring strip 1 with suture hole 6 and suture knot recess 7 with suture hole 16, which is where the knot is placed. The figure also depicts suture slot 9. Knot recess 7 is larger than suture slot 9 to allow for the larger dimensions associated with the knot.

[0077] Figure 1.3 shows a bottom view of the anchoring strip 1. Pusher 30 will drive the entire anchoring strip 1 through the needle tube and out to enter into or behind the tissue. The figure also shows suture slot 11.

[0078] Figure 1.4A cross-sectional view of the anchor strip 1 and suture 40 through hole 16 and suture knot 41 is shown. The suture 40 is threaded or woven through the anchor strip 1 throughout, in and out through suture holes 6 and suture slots 9 and 11. Another key feature of the invention is that the slots 9 and 11 for the suture 40 are staggered with respect to each other to allow for the provision of an increased cross section 19. If the suture 40 is placed through the anchor strip 1 in a straight line, the cross section 19 will be approximately one half the thickness and can fail when the suture 40 is pulled tight after deployment. Failure is manifested by the suture snapping or sawing through the cross section.

[0079] In previous flip-type devices and conventional thinking, the suture is typically placed through the anchor in a straight line, leaving a small cross section for the suture to slide through after deployment. Typical flip-type devices are manufactured using a tube or rod with holes drilled through it. The cross section is the minimum that the suture 40 can slide through and remain necessary, as shown, and is especially necessary for anchors 3 and 4, as they require the suture 40 to slide through the device to achieve deployment. Figure 6.1

[0080] Figure 2 A side view of the anchor strip 1 loaded into the segmented needle 50, through the tissue 55 and ready for deployment is shown. Another key feature of the invention is that because of the rigid connection (notch 8) between each anchor, the user can control all of the anchors 2, 3 and 4. This control is necessary for the orientation of each anchor so that it flips correctly in the upright position and allows the suture to freely move out of the anchor's slot 9. If not oriented in the upright position and the suture cannot freely move out of the slot, the anchor will not flip correctly, resulting in the device being pulled out of the tissue 55.

[0081] Another control feature is the linear motion of the needle. If the anchors are not connected to the drive mechanism, they can fall out of the needle and into the body. Additional design features (including some sort of stop structure for the needle) are typically required to prevent this from happening.

[0082] It should be noted that the needle 50 can also be deployed to a mid-level position in the tissue 55, rather than through the tissue 55.

[0083] Figures 3 to 3.2 A side view of the anchor strip being advanced and ready for deployment is shown. An alternate connection or fit with the advancer tube is also shown.

[0084] Figure 3 A side view of the anchor strip 1 being advanced beyond the needle 50, with anchor 2 protruding beyond the needle tip 56 is shown.

[0085] Figure 3.1 ​The anchor 2 of the anchor strip 1 is shown advanced by the pusher 30 beyond the segment needle 50 and needle tip 56. At the distal end of the pusher 30, the pusher 30 is connected with the anchor strip 1 as a single unitary unit. Then, at the proximal end of the pusher 30, the pusher 30 is connected with the drive hub 70.

[0086] Figure 3.2 An alternate embodiment is shown in which the anchor strip 1 can be connected with the pusher 30 via the notch 60 to connect or mate with the proximal end of the anchor 4.

[0087] Figures 4 to 4.3 Is a view of the handle, drive hub, and ball tip plunger.

[0088] Figure 4 The handle 80 with drive hub 70 and the proximal end of the suture 40 are shown. The detents 71 are also shown.

[0089] Figure 4.1 The entire device is shown.

[0090] Figure 4.2 A hidden view of the assembly is shown with the ball tip recess 72 engaged with the detents 71. There are a total of four detents. This figure also depicts the pusher 30 connected with the drive hub 70 running through the handle 80 and through the needle 50.

[0091] Figure 4.2 And Figure 4.3 An indicator 73 on the drive hub 70 is shown. These indicator numbers correspond to the four detents. When the indicator shows "0", it corresponds to the first or most distal detent 75 which engages with the ball tip plunger 72 and the anchor 2 is behind the needle tip 56 (as shown). Figure 2 The indicator is "1" when it corresponds to the second detent 76 where the anchor 2 is ready for deployment and at this time protrudes beyond the needle tip 56 (as shown). Figure 3 The "0" position will no longer be visible at the indicator "1" position. The anchor 2 will be the first anchor ready for deployment and corresponds to the indicator "1" which indicates the first anchor ready for deployment. The indicator "2" corresponds to the next detent 77 and second anchor which places the anchor 3 in the same previous position as the anchor 2 at this time the anchor 3 protrudes beyond the needle tip 56. Each successive indicator number will advance the next anchor ready for deployment.

[0092] Figures 5 to 5.1 Is a view of the anchor 2 being deployed.

[0093] Figure 5The first anchor 2 is shown detached from the anchor strip 1 and behind the tissue 55. When the pusher 30 is pushed and then the suture 40 is pulled, the first anchor 2 will detach and flip via the notches 8. The suture 40 allows the first anchor 2 and now shortened anchor strip to remain connected, which now consists of two anchors (anchors 3, 4). The suture 40 is fixed to the first anchor 2 by a knot 41 and is not slidable. Another key feature of the present invention is the breakable tab 8, which allows for a controlled detachment of the anchor. This controlled detachment is key to the flipping or flipping over of the anchor when the suture is pulled. Existing flip-over anchors do not consistently flip over, resulting in the anchor device being pulled out, especially in a layered environment in the tissue.

[0094] Figure 5.1 The first anchor 2 is shown flipped over and behind the tissue 55. This is achieved by removing the needle 50 from the tissue 55 and pulling the suture 40, which is locked behind the tissue 55.

[0095] Figures 6 to 6.1 is a view of the plurality of anchor arrangements.

[0096] Figure 6 The anchor 2 is shown having been delivered, flipped over and locked behind the tissue 55, the anchor 3 has been delivered, flipped over and is ready to be locked. After the needle 50 is removed and when the anchor 3 is locked behind the tissue 55, the suture 40 can be pulled tight to allow for a tightening between the anchors 3 and 4, which allows for the implementation of a tightening.

[0097] Figure 6.1 The anchors 2, 3 and 4 are shown deployed behind the tissue 55. The free end of the suture 40 can be pulled tight, the suture 40 can be slidable freely within the anchors 3 and 4. After tightening, a tightening anchor similar to the type tightening anchor (Apollo Endo-surgery, Austin, Texas, USA) can be applied to the area 42 of the suture 40.

[0098] Figure 7 The tightening anchor 4a is shown in place of the anchor 4. This figure shows a V-shaped groove 90 for the suture (not shown) to wedge into. This tightening anchor is used in place of the known type device and is placed on the distal side of the tissue 55 as shown in the anchor 4 arrangement. The suture 40 will then be cut in the area 42 with a suture cutting instrument.

[0099] Figure 7.1 The tightening anchor 4a is shown in place of the anchor 4. This figure shows V-shaped grooves 90 and 91 for the suture (not shown) to wedge into.

[0100] In an alternative embodiment according to the present disclosure, a currently available forward looking linear array echoendoscope is inserted into the patient following conventional and known methods. A location for first full layer anchor deployment is selected. The endoscope is used to identify if any major vessels or adjacent structures are present, and if so, the endoscope can be adjusted accordingly.

[0101] EUS allows one to see full layer penetration on each pass to avoid blood vessels and other organs, while linear deployment allows for increased flexibility and maneuverability. The anchor is essentially a T-shaped fastener or similar that provides a more robust anchor on a point-to-point basis. The choice of suture material is no longer limited by the device, allowing for more robust applications. The EUS guided approach also allows us to make transmural appositions that have never been made before.

[0102] A needle 50 is loaded through the working channel of the endoscope and locked in place at the biopsy valve with a luer lock mechanism as is standard with all EUS needles. The needle will be preloaded with a first tissue anchor that will be positioned behind the fixed wedge of the needle tip. A suture runs through the center of the needle and exits at the back end of the handle. In addition, an open stylet is positioned behind the tissue anchor and placed alongside the suture such that when it is pushed into a downward position, it effectively pushes the anchor out of the needle.

[0103] Figure 8 is a digital image (photo) showing the anchor 4 protruding from the needle 50. The anchor 4 is loaded with a suture 40. The anchor 4 includes a v-shaped groove 90 in which the suture 40 is installed.

[0104] Figure 9 is a digital image of the drive hub 70 and indicator 73. The needle 50 protrudes from the handle 80.

[0105] Figures 10 to 15 is a digital image showing the deployment process. Figure 10 shows the anchor strip 1 that has been installed in the needle 50, ready for insertion into the subject. Figure 11 shows the anchor 2 being detached from the anchor strip 1. The orientation of the anchor 2 secures the anchor 2 within the subject’s tissue. Figure 12 shows the action of utilizing the drive hub 70 to perform suturing. As the anchor 2 is deployed, the handle 80 of the device is pulled out of the subject, thereby extracting the needle 50 from the subject’s tissue. This pulling force must not be sufficient to also extract the anchor 2 from the subject. Figure 13The anchor 2 is shown detached from the needle 50 and anchor strip 1, while the suture 40 remains attached. In actual deployment, the anchor 2 remains within the subject’s tissue anchoring the suture 40. The device is then moved to the next anchor location and the needle 50 is inserted into the tissue at the next anchor location and the drive hub 70 is advanced to the next indicator 73. Figure 15 The deployment process is repeated as needed to complete the suturing process.

[0106] After the first anchor deployment, the needle is retracted and the ultrasound endoscope is pulled back from the location of the first anchor deployment. At this point, the suture continues through the center of the needle and out the needle tip. A second anchor is loaded (it can also be pre-loaded) by pulling out the tube core pusher, threading the anchor over the suture, and using the tube core pusher to push the anchor to the needle tip. The anchor automatically stops on the fixed wedge, which allows the endoscope and suture to move independently of the needle and anchor.

[0107] A second location for anchor insertion is then selected and the above steps are repeated. The second anchor is deployed transmurally. The process is repeated until a sufficient number of anchors are deployed transmurally to provide sufficient tissue apposition when cinched. Cinching is performed by removing the needle from the endoscope channel and using a cinch over the suture. Alternatively, a removable inner needle design allows the inner needle core to be removed while leaving the needle sheath and handle in place. The cinch is pushed against the tissue and the suture is pulled against the cinch, bringing all the tissue anchors together. The suture and anchors move independently of each other until they are cinched tightly. The process is repeated using a new first anchor, followed by a second continuous transmural application using a second tissue anchor and a second cinch.

[0108] There will be a first tissue anchor and a second anchor. The first anchor is the anchor used for the first transmural pass. The first anchor is unique in that it is fixed to the suture. In the second anchor, the suture freely passes through the anchor as the user tightens the suture. The first anchor is critical for pulling all the intervening tissue together with the final cinch. The anchors and / or anchor strips can be a simple rod design, where each anchor hinges to act as a T-shaped flag once transmurally passed. Alternatively, more complex designs using shape memory nickel titanium alloys can be envisioned, such that the anchor forms a Y shape once pushed out of the needle. The suture couples to this anchor, which is different from the second anchor where the anchor freely passes over the suture. The suture is attached to the anchor at the midpoint, so once cinched, the pressure is able to be evenly distributed.

[0109] The second anchor is unique and allows the device to deploy multiple such anchors, achieving coaptation at multiple points of tissue. They are made of the same material and size as the first anchor, but are shaped so that the suture is threaded through the center at the midpoint. This allows the anchor to hinge, and once it is pushed through the tissue wall, the anchor does not allow the suture to be pulled out. A simple design A is conceivable, but more intricate designs are possible. One such design is a tightly wound coil that is pushed through the needle when deployed. When the needle and suture are pulled back, due to the length of the coil, the coil cannot be pulled out, but rather "bunches up" to form a knot. This particular design can be easier to deploy when there is increased resistance to the endoscope and needle position due to bends and tortuosity.

[0110] Figure 16 An endoscopic needle 50 is shown schematically. The needle tip 56 is conical in shape, configured to house the anchor strip 1 prior to deployment. Figure 17 A perspective view of the needle 50 is shown schematically, detailing the conical tip 56. The conical shape facilitates insertion into the subject's tissue. Figure 18 A side view of the needle 50 is shown schematically, further illustrating the conical needle tip 56.

[0111] Figure 19 And Figure 20 A side hidden assembly view of an optional device structure is shown. Figure 19 And Figure 20 A drive hub 70 engaged within a handle 80 is shown schematically. The handle 80 includes a channel for guiding the needle 50. Figure 21 A top hidden assembly view of an optional device structure is shown, including a drive hub 70 engaged within a handle 80 and a channel for guiding the needle 50.

[0112] Figure 22 A side hidden view of the drive hub 70 is shown schematically. Figure 22 The channel for the suture 40, stop, indicator 73, and ball plunger 72 are detailed. The arrow indicates the direction in which the ball plunger 72 is depressed to deploy the suture 40. Figure 23 A side view of the drive hub 70 is shown, and Figure 24 A top view of the drive hub 70 is shown schematically.

[0113] Figure 25 A side view of the anchor strip 1 is shown schematically, including three anchors 2, 3, 4 and a retainer 5, all connected by notches 8. Anchor 2 is the first anchor 2, followed by second anchors 3 and 4. Figure 26A top view of anchor strip 1 is shown schematically, with suture hole 6 and suture knot recess 7, which is where the knot is placed, with suture hole 16. The figure also depicts suture slot 9. Knot recess 7 is larger than suture slot 9 to allow for the increased size associated with the knot. Figure 27 A side profile view of anchor strip 1 is shown schematically.

[0114] Figure 28 A needle 50 with an optional angled conical design is shown schematically. As with standard fine needle aspiration (FNA), needle 50 is pushed into the ultrasound field. Needle 50 is carefully pushed through the tissue wall under ultrasound guidance, and once we are sure on ultrasound that needle 50 is full layer through, it is pulled back just to the edge of the tissue wall and deployed simultaneously as the user pulls the needle back. Figure 14 Deploying anchor 1. When the space for deployment is very small, the needle is first pushed through the wall to ensure transmural (trans / capsular) penetration, then the needle is pulled back just to the edge of the tissue wall and deployed simultaneously as the user pulls the needle back.

[0115] In an alternative embodiment, when there is little or no gap between the lumen peritoneal structures (e.g. gall bladder or liver abutting the stomach), a solution / gel can be injected through needle 50 to create space prior to insertion of the T marker. This technique involves: inserting the needle to sufficiently ensure that the capsule is traversed, then pulling the needle back to the edge of the tissue. At this point, as the needle is pulled back, the anchor is pushed out, which allows for an “in situ” deployment when there is limited gap or space between the lumen peritoneal structures.

[0116] Figure 29 And Figure 30 An optional anchor and needle tip configuration is shown schematically. As Figure 29 And Figure 30 The needle tip can be tailored to correspond to the desired anchor configuration, as shown. Optional anchor configurations can include expanding anchors, ring anchors, through anchors, spiral anchors, Y-shaped anchors, etc.

[0117] The anchor material can vary depending on the application. The first and second anchors also need not be made of the same material. The transmural anchor needs to be made of a human body acceptable material (i.e. stainless steel, nitinol, etc.). It can also be made of a bioabsorbable material. In most applications, the suture does not mean that it needs to remain in the tissue apposition for months. Rather, over time, scar formation and body healing make the suture less important. Polyglycolic acid (PGA) can be employed to form the anchors and suture. This means that even if transmural, the anchors will be effectively absorbed after a few months, so they do not have any impact in the long term.

[0118] Figure 31 And Figure 32The suturing process as described above is shown schematically. Notably, Figure 31 Insertion of needle 50 at step (1) is shown, as well as deployment of first anchor 2, insertion of trailing suture 40 and second needle 50 at step (2). Figure 32 The complete suturing process is shown, in which four anchors 1 are deployed and connected by suture 40. Suture 40 can be tightened by pulling on it. Tightening suture 40 closes the opening in the tissue.

[0119] Figure 33 And Figure 34 A needle-anchor fixation mechanism is shown schematically, which enables needle 50 to load anchor strips 1 and suture 40. Anchor strips 1 are positioned behind fixation wedge and held in place by the wedge. The drive hub (not shown) includes a tube core pusher configured to push the anchor strips through the fixation wedge and initiate deployment of anchor 1. Finally, needle 50 and tube core pusher are hollow to allow passage of suture 40.

[0120] The needle-anchor fixation mechanism allows the anchors to be reliably positioned just in front of the tip of the needle. Without this fixation mechanism, in the case of a simple operating endoscope, there would be unintentional premature deployment or accidental pushing out. The wedge will yield to the pressure from the push tube core when the anchor is being delivered. With the aid of this wedge mechanism, the suture is able to pass down the center of the needle and through each anchor to be deployed. This is key to deploying multiple anchors in a complex pattern.

[0121] Similarly, the push tube core allows the suture to pass down the center of it. The anchors are loaded and delivered to the distal tip of the needle by the push tube core. The suture passes through the entire needle and anchor. Other variants of the needle can be envisaged, which allow multiple second anchors to be preloaded with the needle. In this case, the wedge allows deployment of a single anchor while selecting a position for the placement of the next anchor.

[0122] A summary of the features of the present disclosure includes: the EUS guided system using existing EUS platforms and EUS needle based technology, which the user can easily adapt to; the needle based anchor deployment system with linear action mechanism eliminates any suture management issues; the tissue anchors are deployed through the needle in an EUS guided transmural manner; the anchors can be simple T-shaped tags or a tri-pronged anchor design (e.g., trident). The tags or anchors can be made of Nitinol or even from absorbable materials (e.g., PGA). Furthermore, due to the design of the system, we can offer multiple choices in the suturing material (e.g., absorbable vs. non-absorbable, woven vs. non-woven, 0 gauge vs. 2-0 gauge, etc.).

[0123] In alternative embodiments, the present disclosure provides a solution to prevent any T-tag or similar anchor from eroding or migrating into or adjacent other organs (e.g., into the mediastinum) when positioned on the serosal side of an organ. Since the T-tag or anchor is deployed linearly and under tension during deployment, this does not create a cross-stitch effect. In fact, any erosion or migration will move inward, given that the suture is under tension when applied.

[0124] The anchors move independently on the suture and then cinch at the end; each fastener acts as a transmural anchor while the cinch is on the luminal side. The anchor securing wedge allows the suture and needle to move freely until the anchor is ready for deployment through tissue - thus multiple anchors can be deployed in series on the same suture. This is a major innovation compared to past prototypes and designs that required two independent sutures and anchors to be cinched together. Past designs did not allow for more than a two-point apposition. Our solution can be scaled depending on the number of transmural deployed anchors.

Claims

1. A suture anchor system comprising: a hypodermic needle; a component of suture anchors, the component having a proximal end and a distal end, wherein the proximal end comprises a pusher, and wherein the distal end comprises a plurality of connected suture anchors; and wherein the pusher and the plurality of connected suture anchors are integrally manufactured as a single piece structure.

2. The suture anchor system of claim 1, wherein the plurality of suture anchors are frangibly connected.

3. The suture anchor system of claim 1, further comprising: a suture, the suture being connected with the plurality of suture anchors.

4. The suture anchor system of claim 1, wherein the hypodermic needle is a hollow hypodermic needle comprising an endoscopic needle or an endoscopic ultrasound needle.

5. The suture anchor system of claim 4, wherein the component of a plurality of suture anchors is configured to be located inside the hollow hypodermic needle.

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

7. The suture anchor system of claim 6, wherein the plurality of suture anchors comprises a suture hole and a suture knot groove, the suture anchor system configured to detach the first suture anchor from the plurality of suture anchors after insertion into a subject's tissue.

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

9. The suture anchor system of claim 1, wherein a handle is configured to house the pusher and the hypodermic needle.

10. The suture anchor system of claim 9, wherein a ball tip plunger protrudes from the handle, allowing for manual operation of the suture anchor system.

11. A method of suturing an opening in a subject's tissue, the method comprising: preparing a suture anchor system comprising a pusher and a plurality of suture anchors, wherein the pusher and the plurality of suture anchors are integrally manufactured as a single piece structure; deploying a first anchor to a first suture anchor point in a subject's tissue by inserting a hypodermic needle loaded with the plurality of suture anchors into the subject's tissue; withdrawing the needle; moving the needle to a second suture anchor point; deploying a second suture anchor to the second suture anchor point by inserting the hypodermic needle loaded with the plurality of suture anchors into the subject's tissue; repeating the deploying the suture anchors as needed; and tightening the suture.

12. The method of claim 11, wherein deploying the first anchor comprises driving the first anchor into an inside of the tissue being sutured.

13. The method of claim 12, wherein, detaching the first anchor from the plurality of suture anchors once the first anchor is driven into the inside of the tissue.

14. The method of claim 11, wherein withdrawing the needle comprises feeding the suture from an inside of the tissue to an outside of the tissue.

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

16. The method of claim 11, wherein deploying the second suture anchor comprises: driving the second suture anchor into an interior of the tissue, and separating the second suture anchor from the plurality of suture anchors.

17. The method of claim 11, wherein tightening the suture comprises pulling the suture such that the suture anchors and the suture cause tissue to be brought together to induce healing.

18. A suturing kit comprising: a hypodermic needle, a pusher, and a plurality of connected suture anchors; wherein the pusher and the plurality of connected suture anchors are manufactured as a single breakable unit.

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