Breakaway suture anchor strips and systems, devices, and methods for using same

Abstract

Breakaway anchor strips may include a plurality of anchors frangibly (or breakably) connected to one another via tabs or connectors positioned on alternating sides of the strip. A suture may be fed, or threaded, through each of the plurality of anchors and, once deployed within target tissue, a force or tension may be exerted on the suture that causes one of the anchors to break away, or snap apart from, from the breakaway anchor strip. At times, an anchor of the plurality of anchors may be a cinching anchor configured to cinch sutured tissue together via cooperation with a cutting anchor. The cutting anchor may include an extension configured to cooperate with the cinching anchor such that when they are fit together, the suture is cinched and / or cut, thereby completing the suturing.

Description

BREAKAWAY SUTURE ANCHOR STRIPS AND SYSTEMS, DEVICES, AND METHODS FOR USING SAMERELATED APPLICATION

[0001] The present application is an INTERNATIONL (PCT) application claiming priority to U.S. Provisional Patent Application Number 63 / 552,244 filed on 12 February 2024 and entitled “Anchor Strip with Built-In Cinching and Cutting Anchors,” U.S. Provisional Patent Application Number 63 / 552,250 filed on 12 February 2024 and entitled “Hypotube for Puncturing Tissue and Delivering Suture Anchors”, U.S. Provisional Patent Application Number 63 / 555,507 filed on 20 February 2024 and entitled “Anchor Deployment Handle”, U.S. Provisional Patent Application Number 63 / 555,510 filed on 20 February 2024 and entitled “Hypotube For Puncturing Tissue And Delivering Suture Anchors”, U.S. Provisional Patent Application Number 63 / 564,554 filed on 13 March 2024 and entitled “Anchor Deployment System with Fluoroscopic Guidance”, U.S. Provisional Patent Application Number 63 / 571 ,953 filed on 29 March 2024 and entitled “Suturing Breakaway Anchor Strip For Use On Internal And External Tissues”, U.S. Provisional Patent Application Number 63 / 640,386 filed on 30 April 2024 and entitled “Design for Grasping Tissue For An Anchor Delivery System”, U.S. Provisional Patent Application Number 63 / 645,214 filed on 10 May 2024 and entitled “Suturing Breakaway Anchor Strip”, and U.S. Provisional Patent Application Number 63 / 678,423 filed on 01 August 2024 and entitled “Breakaway Suture Anchor Strips Including Grooves And Methods For Using Same For Suturing Internal And External Patient Tissue”, all of which are incorporated by reference, in their respective entireties, herein.FIELD

[0002] The present invention is directed to medical devices and, in particular to strips including a plurality of surgical suture anchors frangibly connected to one another.BACKGROUND

[0003] Techniques to improve transmural and tissue and luminal apposition are necessary for a variety of clinical indications. Tissue apposition can be performed by through-the-scope clips (TTSC), over-the-scope-clips (OTSC), and endoscopic suturing(ES) systems. These procedures lack precision, reliable transluminal suturing, and a durable and robust lumen apposition, and do not reliably achieve full thickness suturing or account for extraluminal structures. Further, they are not durable due to suture “cheese-wiring” through tissue and are too cumbersome for widespread dissemination.

[0004] Uses for transmural suturing include: gastroplasty for the treatment of overweight / obesity and its associated comorbidities such as metabolic disease; anastomotic reduction (e.g. gastric outlet and pouch reduction for the treatment of weight regain and / or dumping syndrome post gastric bypass; securing implants (e.g., self-expandable metallic stents) to the luminal wall; closure of defects involving the muscularis propria (e.g., closure of fistula / leak, after full-thickness resection of a lesion in the luminal digestive tract); anti-reflux procedure; gastropexy for sliding hiatus hernia; and tethering to the edges of a stricture with or without dilation to pry it open.

[0005] Endoscopic ultrasound (EUS) guided lumen apposition include lumen apposing metallic stents (LAMS) that have improved EUS-guided creation of an anastomosis for uses in, for example, gallbladder drainage and gastroenteric anastomosis are examples and drainage of abdominal collections. However, issues remain such as the gallbladder or small bowel is pushed away during insertion of the LAMS deployment catheter, and an insufficient length of LAMS deployment catheter is able to be inserted into the gallbladder or small bowel and the distal flange is opened between the stomach and the gallbladder or small bowel.

[0006] Flexible endoscopic methods for tissue resection are quickly gaining momentum which gives rise to a desperate need to create a 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 and this must be robust and secure. There is currently no easy, safe, and reliable way to perform full thickness suturing in the gastrointestinal (Gl) tract. Current technology, such as the Apollo® Overstitch, while it claims to be full thickness, often falls short or overshoots in real life practice.

[0007] The technical difficulty and invasive nature of endosurgical procedures is offset by the ability to suture and provide safe closure. There is currently no way to use imaging to guarantee transmural or full thickness placement of suture / fastener / anchor.All suturing is effectively blind, and since there is no tactile feel of the tissue being sutured, there is no ability to say that full thickness suturing is being performed reliably. There is no through the scope suturing technology that allows for full thickness plication that is currently commercially available. Over the scope attachments create maneuverability and visibility issues in real life application.

[0008] Current technologies are limited by the suture size (e.g., 2-0) due to the needle size and subsequent concerns for bleeding as vessels are not within endoscopic view during the suturing process. Current technologies are cumbersome for the average user and carry a steep learning curve and is limited to one type of suture. Nonlinear deployment makes suture management complex and novice users suffer from poorly placed sutures: these either break, become tangled, or give a false sense of secure closure.SUMMARY

[0009] The breakaway suture anchor strips (also called “breakaway anchor strips herein) disclosed herein may be used to suture tissue (e.g., skin, organ tissue, muscular tissue, ligament tissue, cartilage, and / or tendon tissue) together and may include a body and a pushrod in physical communication with the body. At times, the pushrod may be frangibly bonded to the breakaway anchor strip. Additionally, or alternatively, the pushrod and a breakaway anchor strip may be a monolithic unit that is manufactured (injection molded, mill, 3-D printed, etc.) to be one piece that includes the body and a pushrod that are frangibly connected to one another.

[0010] The body may include a plurality of anchors that are frangibly connected to one another. For example, the body may include a first anchor; a second anchor that is connected to the first anchor by a first tab positioned on a first side (e.g., top or left) of the body and separated from the first anchor by a first groove positioned on a second side (e.g., bottom or right) of the body; and a third anchor that is connected to the second anchor by a second tab positioned on the second side of the body and separated from the second anchor by a second groove positioned on the first side of the body.

[0011] In some embodiments, a suture may extend through the first, second, and third anchors. Optionally, the suture may further extend through the pushrod. At times, when force is applied to the suture, the first tab may break, thereby separating the first anchor from the second anchor so that it may remain at a position within target tissue of a patient and anchor the suture within or proximate to the target tissue. This process may be completed until some, or all, anchors of the breakaway anchor strip are separated from one another and placed within target tissue to suture and anchor the target tissue together.

[0012] In some embodiments, the breakaway anchor strips disclosed herein may have a non-circular (e.g., ovoid, triangular, and / or irregular) cross-sectional shape along a plane perpendicular to a length of the breakaway anchor strip. In these embodiments, the non-circular cross-sectional shape may be configured to fit within and cooperate with a hypo tube that has a corresponding non-circular cross-sectional shape to, for example, prevent rotational movement (e.g., spinning about the axis of a lumen of a hypo tube) of the breakaway anchor strip with a lumen of a hypo tube, which may provide greater accuracy and efficiency when suturing tissue using the disclosed breakaway anchor strips.

[0013] In some embodiments, an anchor (e.g., the anchor connected to the pushrod) of the breakaway anchor strips disclosed herein may be a cinching anchor comprising a lumen sized, positioned, and configured to accept and retain an extension of a cutting anchor. In these embodiments, a suture may extend through all of the anchors of the breakaway, anchor strip, including the cutting anchor and the cutting anchor may include the extension and a cutting edge configured to cut the suture when the extension may be positioned within the lumen of the cinching anchor. Cutting the suture in this manner, may facilitate cinching and closing off the suture tissue and removing excess suture from the tissue.

[0014] In some embodiments, the pushrod has a central lumen and / or may be configured to extend through a length of an endoscope via, for example, a channel of the endoscope. Additionally, or alternatively, the body of a breakaway anchor strip may have a lumen in communication with the lumen of the pushrod and the lumens of the body and pushrod may be configured to allow communication of medical fluid (e.g., dye,medication, saline, etc.) therethrough to, for example, target tissue. In some embodiments delivery of the medical fluid to the target tissue may be facilitated by and one or more fenestrations in the pushrod open to the lumen. The one or more fenestrations may be configured and positioned to allow communication of the medical fluid from the lumen of the pushrod into at least one of a channel of an endoscope in which the pushrod may be positioned and a lumen of a hypo tube in which the breakaway anchor strip may be positioned.

[0015] Delivery catheters of an endoscope disclosed herein may include a tube with a sidewall that defines a central lumen and a first end physically coupled to the endoscope, the central lumen may be configured to be in communication with a central channel of the endoscope and may further include a corkscrew extension physically coupled to a second end of the tube, the corkscrew extension including a pointed tip configured to puncture tissue. The central lumen may be sized and configured to accept insertion of an assembly of a hypo tube and a breakaway anchor strip therein, wherein the breakaway anchor strip is resident within a lumen of the hypo tube. At times, an external diameter of the hypo tube may be smaller than an internal diameter of the tube so that a medical fluid may travel through the central lumen of the tube and be communicated to the tissue. Additionally, or alternatively, an external diameter of the breakaway anchor strip may be smaller than an internal diameter of the hypo tube so that a medical fluid may travel through the hypo tube and be communicated to the tissue.

[0016] In some embodiment, the corkscrew extension may be configured and / or operable to engage tissue so that the tissue may be secured against the second end of the delivery catheter while an anchor from the breakaway anchor strip is deployed into the tissue.

[0017] When suturing together tissue, an assembly of a suture and a breakaway anchor strip may be loaded into a hypo tube extending from an endoscope (via, for example, a channel of the endoscope). Optionally, a first portion of the suture extends through the hypo tube and the channel of the endoscope. The breakaway anchor strip may include an anchor and an exploded assembly of a cinching anchor and a cutting anchor. The exploded assembly of a cinching anchor and a cutting anchor may includea cinching anchor and a cutting anchor that are separated from one another by, for example, a frangible tab or compressible material (e.g., a hydrogel or silicone). Optionally, a second portion of the suture may be connected to a tensioning device, such as a spool, that may be attached to and / or extend from a handle of the endoscope.

[0018] Once the breakaway anchoring system is in position within the endoscope and / or hypo tube an active end (e.g., pointed tip) of the hypo tube may be into a first position within, or on, target tissue and an anchor of the breakaway anchor strip may be advanced (e.g., pushed via a pushrod or other mechanism) through the hypo tube and into the first position of the target tissue. Then, tension may be applied to the suture so that the anchor at the first position may be separated (e.g., broken away and / or a tab attaching an anchor to another anchor or breakaway strip may be broken) and the anchor may be seated within / on the target tissue. Optionally, this tension may be applied via turning or otherwise activating a tensioning device engaged with the suture (e.g., a spool) to exert tension on the suture, wherein the tension on the suture separates the anchor from the breakaway anchor strip by, for example, breaking a tab or other device joining the anchor to another anchor, pushrod, or cutting anchor.

[0019] The hypo tube may then be removed from the first position of / within / along the target tissue and, when another anchor is to be placed, the hypo tube may be moved to a second position of / within / along the target tissue and the anchor may be deployed. When the last regular (e.g., not the cinching or cutting anchor) is deployed, the cinching anchor may be deployed within / along / on the target tissue by inserting the hypo tube into a position in / along / within the target tissue where the cinching anchor is to be deployed. The exploded assembly of the cinching anchor and the cutting anchor (i.e., cinching and cutting anchors are separated) may be placed within / along / on the target tissue and tension may be applied to the assembly to fit the cutting anchor within the cinching anchor, which may cut the suture and complete the suturing of the target tissue and / or a portion of the target tissue. In some embodiments, the cutting anchor may be frangibly attached to a pushrod that extends through the channel of the endoscope and advancement of the anchor into the first target tissue may be facilitated by exerting a force on the pushrod. At times, tension may be applied to the suture priorto the extension fitting within the lumen of cinching anchor, to separate the cutting anchor from a pushrod.

[0020] In some embodiments a medical fluid may be added to the channel of the endoscope and / or a lumen of the pushrod and / or breakaway anchor strip for communication to the target tissue via a lumen of at least one of the breakaway anchor strip and the hypo tube.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The present invention is illustrated by way of example, and not limitation, in the figures of the accompanying drawings in which:

[0022] FIG. 1 A is a schematic diagram of a top view of a breakaway anchor strip with alternating grooves, in accordance with some embodiments of the present invention;

[0023] FIG. 1 B is a schematic diagram of a horizontal cross-section view of the breakaway anchor strip of FIG. 1 A taken along a bisecting line shown in FIG. 1A, in accordance with some embodiments of the present invention;

[0024] FIG. 1C is a schematic diagram of a horizontal cross-section view of the breakaway anchor strip of FIG. 1 A with a suture resident therein, in accordance with some embodiments of the present invention;

[0025] FIG. 2A is a schematic diagram of a side perspective view of an exemplary breakaway anchor strip with an ovoid cross section, in accordance with some embodiments of the present invention;

[0026] FIG. 2B is a schematic diagram of a cross-section view (taken along line 2B-2B of FIG. 2A) of an anchor of the breakaway anchor strip with an ovoid cross section of FIG. 2A, in accordance with some embodiments of the present invention;

[0027] FIG. 2C is a schematic diagram of a cross-section view (taken along line 2C-2C of FIG. 2A) of a pushrod of the breakaway anchor strip with an ovoid cross section of FIG. 2A, in accordance with some embodiments of the present invention;

[0028] FIG. 2D is a schematic diagram of a top view of the breakaway anchor strip with an ovoid cross section of FIG. 2A, in accordance with some embodiments of the present invention;

[0029] FIG. 2E is a schematic diagram of a longitudinal cross-section view of the breakaway anchor strip with an ovoid cross section of FIG. 2A, in accordance with some embodiments of the present invention;

[0030] FIG. 2F is a schematic diagram of a side perspective view of another exemplary breakaway anchor strip with an ovoid cross section, in accordance with some embodiments of the present invention;

[0031] FIG. 3A is a schematic diagram of a side perspective view of an exemplary breakaway anchor strip with an ovoid cross section, in accordance with some embodiments of the present invention;

[0032] FIG. 3B is a schematic diagram of a cross-section view (taken along line 3B-3B of FIG. 3A) of an anchor of the breakaway anchor strip with an ovoid cross section of FIG. 3A, in accordance with some embodiments of the present invention;

[0033] FIG. 3C is a schematic diagram of a cross-section view (taken along line 3C-3C of FIG. 3A) of a pushrod of the breakaway anchor strip with an ovoid cross section of FIG. 3A, in accordance with some embodiments of the present invention;

[0034] FIG. 4A is a schematic diagram of a side view of a cinching breakaway anchor strip, in accordance with some embodiments of the present invention;

[0035] FIG. 4B is a schematic diagram of a cross-section view of a cinching anchor of the cinching breakaway anchor strip of FIG. 4A taken along line 4B-4B as shown in FIG 4A, in accordance with some embodiments of the present invention;

[0036] FIG. 4C is a schematic diagram of a side view of a cutting anchor of the cinching breakaway anchor strip of FIG. 4A seated within cinching anchor, in accordance with some embodiments of the present invention;

[0037] FIG. 4D is a schematic diagram of a cross-section view of the cutting anchor seated within cinching anchor taken along line 4D-4D as shown in FIG 4C, in accordance with some embodiments of the present invention;

[0038] FIG. 4E is a schematic diagram of a side view of the cinching breakaway anchor strip of FIG. 4A with a separation device positioned between the cinching anchor and the cutting anchor, in accordance with some embodiments of the present invention;

[0039] FIG. 5A is a schematic diagram of a cutaway perspective view of an exemplary endoscope with a tensioning device, in accordance with some embodiments of the present invention;

[0040] FIG. 5B is a schematic diagram of a cutaway perspective view of the endoscope with the tensioning device of FIG. 5A with a breakaway anchor strip positioned therein, in accordance with some embodiments of the present invention;

[0041] FIG. 6A is a schematic diagram of a detailed cross-section view of an active end of an exemplary hypo tube with a retention feature positioned within central lumen thereof, in accordance with some embodiments of the present invention;

[0042] FIG. 6B is a schematic diagram of a top view of the active end of the hypo tube of FIG. 6A, in accordance with some embodiments of the present invention;

[0043] FIG. 6C is a schematic diagram of a cross-section view of an active end of another hypo tube with a retention dimple positioned in a lumen thereof, in accordance with some embodiments of the present invention;

[0044] FIG. 7A is a schematic diagram of a side perspective view of an exemplary hypo tube with a non-circular (e.g., ovoid) cross-sectional shape along its length, in accordance with some embodiments of the present invention;

[0045] FIG. 7B is a schematic diagram of a cross-section view of the hypo tube of FIG. 7A, in accordance with some embodiments of the present invention;

[0046] FIG. 7C is a schematic diagram of breakaway anchor strip with an ovoid cross section of FIG. 2A seated within the hypo tube of FIG. 7A, in accordance with some embodiments of the present invention;

[0047] FIG. 7D is a schematic diagram of a side perspective view of a hypo tube with a non-circular (e.g., triangular) cross-sectional shape along its length, in accordance with some embodiments of the present invention;

[0048] FIG. 7E is a schematic diagram of a cross-section view of the hypo tube of FIG. 7D, in accordance with some embodiments of the present invention;

[0049] FIG. 7F is a schematic diagram of breakaway anchor strip of FIG. 3A seated within the hypo tube of FIG. 7D, in accordance with some embodiments of the present invention;

[0050] FIG. 8A is a schematic diagram of a side view of a delivery catheter with a corkscrew extension positioned proximate to target tissue, in accordance with some embodiments of the present invention;

[0051] FIG. 8B is a schematic diagram of a spiral portion of the corkscrew extension engaged with target tissue, in accordance with some embodiments of the present invention;

[0052] FIG. 8C is a schematic diagram of a hypo tube inserted into the target tissue engaged with the corkscrew extension, in accordance with some embodiments of the present invention;

[0053] FIG. 8D is a schematic diagram of an anchor deployed into the target tissue, in accordance with some embodiments of the present invention;

[0054] FIG. 9 is a schematic diagram of a side view of a delivery catheter with a plurality of grasping hooks extending therefrom, in accordance with some embodiments of the present invention;

[0055] FIG. 10 is a schematic diagram of a side view of a delivery catheter with a central lumen large enough to accommodate both a hypo tube and a pair of microforceps that extend from a wire, in accordance with some embodiments of the present invention;

[0056] FIG. 11A is a schematic diagram of a cutaway view of an assembly of an endoscope and a breakaway anchor strip, in accordance with some embodiments of the present invention;

[0057] FIG. 11 B is a schematic diagram of a detailed view of a portion of the assembly of FIG. 11 A, in accordance with some embodiments of the present invention;

[0058] FIG. 12 provides a flowchart illustrating an exemplary process of using one or more breakaway anchor strips to suture target tissue, in accordance with some embodiments of the present invention;

[0059] FIG. 13A is a schematic diagram of a cutaway view of a hypo tube with a breakaway anchor strip positioned within a first target tissue, in accordance with some embodiments of the present invention;

[0060] FIG. 13B is a schematic diagram of a cutaway view of the hypo tube of FIG. 13A with a first anchor deployed through the first target tissue, in accordance with some embodiments of the present invention;

[0061] FIG. 13C is a schematic diagram of a cross-section view of the first target tissue with the first anchor properly seated relative to the first target tissue, in accordance with some embodiments of the present invention;

[0062] FIG. 13D is a schematic diagram of a cutaway view of a hypo tube with a breakaway anchor strip positioned within a second target tissue, in accordance with some embodiments of the present invention;

[0063] FIG. 13E is a schematic diagram of a cutaway view of the hypo tube ofFIG. 13A with a second anchor deployed through the second target tissue, in accordance with some embodiments of the present invention; and

[0064] FIG. 13F is a schematic diagram of a cross-section view of the first target tissue with the second anchor properly seated relative to the first target tissue, in accordance with some embodiments of the present invention.

[0065] Throughout the drawings, the same reference numerals, and characters, unless otherwise stated, are used to denote like features, elements, components, or portions of the illustrated embodiments. Moreover, while the subject invention will now be described in detail with reference to the drawings, the description is done in connection with the illustrative embodiments. It is intended that changes and modifications can be made to the described embodiments without departing from the true scope and spirit of the subject invention as defined by the appended claims.WRITTEN DESCRIPTION

[0066] Described herein are various embodiments of breakaway anchor strips that include a plurality of surgical anchors that are frangibly connected to each other. Separation of an anchor from a breakaway anchor strip is mechanically facilitated by, for example, one or more divots, indentations, and / or alternatingly-placed grooves, tabs, and / or extensions. Inclusion of multiple anchors in a single breakaway anchor strip reduces and / or eliminates the need to handle anchors on an individual basis (e.g.,loading them into a delivery device one at a time), which decreases complexity of operation and saves critical time while suturing patient tissue.

[0067] The breakaway anchor strips disclosed herein may be made using any appropriate material including, but not limited to, stainless steel, titanium, nonabsorbable plastic, bio-absorbable plastic, a hybrid of plastic and ceramic, and combinations thereof. The breakaway anchor strips disclosed herein may be manufactured using any appropriate manufacturing process including, but not limited to, molding, injection molding, cutting, three-dimensional printing, milling, and combinations thereof. The breakaway anchor strips disclosed herein may include any number (e.g., 2-10) of anchors molded and / or assembled into a single strip separated by breaking, or separation, points that may be embodied as, for example, notches, V-shaped notches, semi-circular indents, regions of thin, or easily breakable, material, and / or grooves.

[0068] The breakaway anchor strips disclosed herein are configured to house a single suture strand that runs along the length of the strip and is in communication with each anchor of the breakaway anchor strips. In some embodiments, the suture may be knotted at a distal end of the breakaway anchor strip. Additionally, or alternatively, the breakaway anchor strips disclosed herein may include a suture anchor and / or locking device configured to hold the suture in place.

[0069] The suture may be loaded into the breakaway anchor strip on site (e.g., by a clinician or assistant to a surgeon) and / or preloaded (e.g., by the manufacturer) into a delivery device (e.g., an endoscope) for deployment at a site of use (e.g., target tissue) inside or outside the body. For example, during use and / or deployment, an assembly of a suture and breakaway anchor strip may be placed into a delivery needle of, for example, a delivery device with a distal tip of the breakaway anchor strip kept behind the distal needle tip for ease of insertion of the delivery needle into a first position on / in patient tissue. To deploy the first distal anchor of the breakaway anchor strip, the delivery needle may be inserted into and / or through patient tissue or skin at a first suturing position and, once the delivery needle is in a desired position, the breakaway anchor strip may be advanced through the delivery needle so that a first anchor extends from the delivery needle. Once the first anchor extends from the tip of the delivery needle, a proximal end of the suture may be pulled away from the first anchor and / orpatient tissue via, for example, operation of the delivery device and this pulling may cause the first anchor to snap off or otherwise breakaway / disengage from the breakaway anchor strip, thereby causing the first anchor to toggle forward and lock into or behind the patient tissue at the first suturing position. The delivery needle may then extracted from the first suturing position on / in patient tissue and when repositioned to a second suturing position on / in patient tissue, the delivery needle may be pushed through a second suturing position so that a second anchor of the breakaway anchor strip may be placed in a manner similar to the placement of the first anchor. This process may be repeated until, for example, all anchors of a breakaway anchor strip are used and / or the procedure is complete (e.g., the surgeon is finished suturing).

[0070] In some embodiments, when the final anchor of a breakaway anchor strip is deployed, the suture may be pulled taut, which may create a "purse string" closure of all of the previously deployed anchors and the suture may be knotted, locked, or otherwise secured to keep the sutured tissue closed. Once locked and / or knotted, any remaining and / or unused suture may be cut away from the closure and disposed of.

[0071] In another embodiment, anchors included in a breakaway anchor strip may be configured to separate from one another inside the delivery needle prior to exiting the delivery needle tip. In these embodiments, a distal tip of the delivery needle may be curved so that when a breakaway anchor strip is advanced through the delivery needle and pushed forward into the curve, the most distal anchor snaps off or separates from the strip prior to exiting the delivery needle tip. Once the anchor has exited the delivery needle tip, it is free to toggle and lock into or behind the tissue or skin.

[0072] Turning now to the figures, FIG. 1 A is a schematic diagram of a top view of a breakaway anchor strip with alternating grooves 100, FIG. 1 B is a schematic diagram of a horizontal cross-section view of breakaway anchor strip 100 taken along bisecting line 2-2 shown in FIG. 1A, and FIG. 1C is a schematic diagram of a horizontal crosssection view of breakaway anchor strip 100 with a suture 150 resident therein.Breakaway anchor strip 100 includes a plurality (in this case four) of anchors 110 (also referred to herein as first anchor 110A, second anchor 110B, third anchor 110C, and fourth anchor 110D) partially separated from one another by a groove 130 configured to facilitate separation of an anchor 110 from breakaway anchor strip 100 as neededand / or desired. Anchors 110 are frangibly held together by a thin tab, or extension, 135 connecting one anchor 110 to another. Tabs 135 and a corresponding groove 130 are positioned on alternating and opposing sides of breakaway anchor strip 100, wherein a first tab 135 is positioned on a bottom of breakaway anchor strip 100 between first and second anchors 110A and 110B, a second tab 135 is positioned on a top of breakaway anchor strip 100 between second and third anchors 110B and 110C, a third tab 135 is positioned on the bottom of breakaway anchor strip 100 between third and fourth anchors 110C and 110D, and a fourth tab 135 is positioned on a top of breakaway anchor strip 100 between fourth anchor 110D and pushrod 170 as shown in FIG. 1A. Likewise, a first groove 130 is positioned on a top of breakaway anchor strip 100 between first and second anchors 110A and 110B, a second groove 130 is positioned on a bottom of breakaway anchor strip 100 between second and third anchors 110B and 110C, a third groove 130 is positioned on the top of breakaway anchor strip 100 between third and fourth anchors 110C and 110D, and a fourth groove 130 is positioned on a bottom of breakaway anchor strip 100 between fourth anchor 110D and pushrod 170 as shown in FIG. 1A. Pushrod 170 may be configured to cooperate with a delivery device (not shown) as, for example, disclosed and shown herein to assist with advancing breakaway anchor strip 100 into and down a lumen of a delivery needle so that anchors 100 may be deployed within / on patient tissue.

[0073] Breakaway anchor strip 100 further includes a central channel 120 configured for acceptance of suture 150 and, on some occasions, a medical fluid therein. Each anchor 110 may include one or more holes 125 configured and positioned to facilitate treading suture 150 through breakaway anchor strip 100 so that it is resident within channel 120 as shown in FIG. 1C. In the embodiment shown in FIG. 1C, suture 150 enters a first hole 125 of first anchor 110A and passes to channel 120, then comes up through a second hole 125 of second anchor 110B, passes over an extension 140, goes down a third hole 125 of second anchor 110B, passes through a portion of channel 120 extending between second and third anchors 110B and 110C, comes up through a fourth hole 125 of third anchor 110C, passes over an extension 140, goes down a fifth hole 125 of third anchor 110C, passes through a portion of channel 120 extending between third and fourth anchors 110C and 110D, comes upthrough a sixth hole 125 of fourth anchor 110D, passes over an extension 140, goes down a seventh hole 125 of fourth anchor 110D, passes through a portion of channel 120 extending between fourth anchor 110D and pushrod 170, comes up through an eighth hole 125 of pushrod 170, passes over an extension 140, goes down a ninth hole 125 of pushrod 170 and extends through a portion of channel 120 extending along pushrod 170 until it exits pushrod 170.

[0074] Grooves 130 and tabs 135 may be configured to hold anchors 110 and pushrod 170 of breakaway anchor strip 100 together for easy handling and / or loading into a delivery device and may further be configured to facilitate easy and predictable breakage at defined points (at grooves 130) along breakaway anchor strip 100 so that anchors 110 may be separated from one another for deployment and use within / on patient tissue to suture the patient tissue. Alternating placement of grooves 130 and tabs 135 along the length of breakaway anchor strip 100 provides sufficient structural stability for breakaway anchor strip 100 to enable handling that does not require excessive force to separate anchors 110 from one another during use.

[0075] FIG. 2A provides a side view and FIG. 2D provides a top view of a breakaway anchor strip with an ovoid cross section 200. FIG. 2B provides a crosssection view (taken along line 2B-2B of FIG. 2A) of an anchor 210 of breakaway anchor strip with an ovoid cross section 200 and FIG. 2C provides a cross-section view (taken along line 2C-2C of FIG. 2A) of a pushrod 240 of breakaway anchor strip with an ovoid cross section 200. Breakaway anchor strip with ovoid cross section 200 includes a body 205, comprising a plurality (in this case, five) of anchors 210, and a pushrod 240. Body 205 has an ovoid cross-sectional shape and is configured to cooperate with a hypo tube with a corresponding cross-sectional shape as, for example, shown in FIGs. 7A and 7B and described herein. Each anchor 210 includes a lumen 207 (see FIG. 2B) and pushrod 340 includes a pushrod lumen 247 (see FIG. 2C).

[0076] Each of the plurality of anchors 210 and pushrod 240 are separated from one another by notches 220 configured to provide a controlled breakage or separation point between two anchors 210 and / or between an anchor 210 and pushrod 240 so that, for example, an anchor 210 of body 205 may break away from body 205 when in position (e.g., anchored to tissue) as, for example, disclosed herein.

[0077] As may be seen in the top view of FIG. 2D, breakaway anchor strip with an ovoid cross section 200 also includes suture slots 212 configured to hold or guide motion of suture 150 within breakaway anchor strip with an ovoid cross section 200, suture holes 214 configured to the threading of suture 150 through breakaway anchor strip with an ovoid cross section 200. As may be seen in the top view of FIG. 2E, breakaway anchor strip with an ovoid cross section 200 also includes suture grooves 218 positioned below (as oriented in the figure), a portion of breakaway anchor strip with an ovoid cross section 200 positioned between two suture holes 214 as shown.

[0078] FIG. 2F provides a side perspective view of a breakaway anchor strip with an ovoid cross section and alternating grooves and tabs 201 . Breakaway anchor strip 201 includes a four anchors 21 land a pushrod 241 joined together with tabs 235 positioned on alternating sides of a body 206 with grooves 230 as shown in the figure.

[0079] FIG. 3A provides a side view of a breakaway anchor strip with a triangular cross section 300. FIG. 3B provides a cross-section view (taken along line 3B-2B of FIG. 3A) of an anchor 310 of breakaway anchor strip with a triangular cross section 300 and FIG. 3C provides a cross-section view (taken along line 3C-2C of FIG. 3A) of a pushrod 340 of breakaway anchor strip with a triangular cross section 300. Breakaway anchor strip with triangular cross section 300 includes a body 305, comprising a plurality (in this case, five) of anchors 310, and a pushrod 330. Body 305 has a triangular cross- sectional shape and is configured to cooperate with a hypo tube with a corresponding cross-sectional shape as, for example, shown in FIGs. 7C and 7D and described herein. Each anchor 310 includes a lumen 307 (see FIG. 3B) and pushrod 340 includes a pushrod lumen 347 (see FIG. 3C).

[0080] Each of the plurality of anchors 310 and pushrod 330 are separated from one another by notches 320 configured to provide a controlled breakage or separation point between two anchors 310 and / or between an anchor 310 and pushrod 330 so that, for example, an anchor 310 of body 305 may break away from body 305 when in position (e.g., anchored to tissue) as, for example, disclosed herein.

[0081] FIG. 4A is a side view of a cinching breakaway anchor strip 400 that includes a plurality (in this case, four) of anchors 430, a cinching anchor 435, a cutting anchor 440, and a pushrod 415. Each anchor 430 includes a suture guide 425 sized,shaped, and configured to allow a suture 410 to pass, and articulate (e.g., move to the left (as oriented in the figure)) therethrough. FIG. 4B is a cross-section view of cinching anchor 435 taken along line 4B-4B. Cinching anchor 435 includes an extended suture guide 427 (see FIG. 4A) with a lumen 450 (see FIG. 4B) positioned therein. Lumen 450 may be sized, shaped, and configured to allow a suture 410 to pass, and articulate (e.g., move to the left (as oriented in the figure)) therethrough.

[0082] Lumen 450 may also be sized, positioned, and configured to accept and retain an extension 455 of cutting anchor therein (see e.g., FIGs. 4C and 4D) via, for example, a mechanical engagement, press fit, and / or friction fit. In some embodiments, lumen 450 may include one or more retaining features (e.g., gaskets, ridges, hooks, etc.) configured to engage with extension 455 and hold it in place.

[0083] During use, extension 455 may be pulled into lumen 450 via, for example, tension or force exerted on suture 410 so that extension 455 is seated within lumen 450 and held therein via, for example, a press-fit, friction, and / or other mechanical engagement mechanism (e.g., clips, ridges, etc.). When extension is seated within lumen 450, it may act to cinch suture 410 in place and cutting edge 445 may be configured to cut suture 410 as, for example, shown in FIG. 4G, so that, for example, excess suture 410 may be removed from the suturing location and / or patient’s body.

[0084] In some embodiments, a body 401 including anchors 430 and cinching anchor 435 may be loaded into a hypo tube (e.g., hypo tube 530) and so that they may be deployed to anchor suture 410 in target tissue and cinching anchor 435 to cinch the suture. Then, a separate pushrod including the cutting anchor 445 may be loaded into the hypo tube so that cutting anchor 445 may be seated in cinching anchor (see e.g., FIGs. 4B and 4D) and the suture may be cut, thereby cinching suture 410 and cutting away excess suture.

[0085] Additionally, or alternatively, an exploded assembly of cinching anchor 435 and cutting anchor 445 may be part of (e.g., frangibly bonded to) body 401. The exploded assembly may include one or more separation devices 480 positioned between cinching anchor 435 and cutting anchor 445 as shown in FIG. 4E, which is a side view of a cinching breakaway anchor strip 400 with a separation device 480 positioned between cinching anchor 435 and cutting anchor 445. When tension isapplied to cutting anchor 445, separation device 480 may be deactivated by, for example, breakage and / or compression so that extension 455 may be seated in lumen 450. Exemplary separation devices 480 include tabs, clips, and / or compressible materials such as foam, a hydrogel, or silicone.

[0086] FIG. 5A is a schematic diagram of a cutaway view of an exemplary endoscope with a tensioning device 500 (also referred to herein as “endoscope 500”). Endoscope includes a handle 515, a body 520, and a hypo tube 530. A central channel, or lumen, 535 runs through handle 515 and body 520 and is in communication with a central lumen of hypo tube 530. Central lumen 535 is configured to allow a suture 510 to pass therethrough so that, for example, a first end of suture 510 is in communication with an anchor strip (not shown) resident within hypo tube 530 and a second end of suture 510 is wrapped around, or otherwise engaged with, tensioning device 545 (embodied as a spool in FIG. 5A). Handle 515 includes an opening 510 in communication with central channel 535 and a tensioning mechanism 540 that includes a tensioning device 545 around which a suture 510, or a portion of a suture, may be wound.

[0087] During preparation for use, an assembly of an anchor strip (e.g., one or more of the anchor strips disclosed herein) and suture 510 may be inserted into hypo tube 530 via, for example, insertion into opening 510. Then, the anchor strip along with the first portion of suture 510 may slide down channel 535 into the lumen of hypo tube 530 while the second portion of suture 510 remains outside opening 510 and / or handle 515. Then, the second portion of suture 510 may be wound around tensioning device 545 and an assembly of endoscope 500, the anchor strip, and suture 510 may be ready for use to, for example, suture or anchor patient tissue as, for example, described herein. Further details regarding how the assembly of endoscope 500, the anchor strip, and suture 510 may be used to suture or anchor patient tissue is provided herein with regard to, for example, FIG. 12 and the associated discussion thereof.

[0088] FIG. 5B is a schematic diagram of a cutaway view of endoscope 500 with a breakaway anchor strip 100 positioned within a lumen of hypo tube 530 and pushrod 170 extending through channel 535 and exiting opening 510 so that, for example,pushrod 170 may be pushed into channel 535, thereby advancing anchors of breakaway anchor strip through hypo tube 535 and into patient tissue.

[0089] FIG. 6A provides detailed cross-section view and FIG. 6B provides a top view of an active (e.g., pointed end configured for insertion into patient tissue) end with a cutting tip 625 of hypo tube 530 and a retention feature positioned within central lumen 610 thereof proximate to cutting tip 625. In particular, FIG. 6A provides a crosssection view of an active end of a first hypo tube 530A with a retention wedge 620 extending from an internal surface of first hypo tube 530A into lumen 610. Retention wedge 620 is configured to engage and retain a cooperating feature (e.g., an exterior surface and an anchor, an anchor end, and / or a suture guide (e.g., suture guide 425)) of a suture anchor, such as the suture anchors included in one or more of the anchor strips disclosed herein (e.g., suture anchor strips 100, 200, 300, and / or 400). In some embodiments, retention feature 620 may be ladder cut into hypo tube 530. At times, retention feature 620 may be configured so that it provides a small amount of resistance to a breakaway anchor strip as it is advanced along hypo tube 530 to deploy an anchor.

[0090] FIG. 6C provides a cross-section view of an active end of a second hypo tube 530B with a retention dimple 625 extending from an internal surface of second hypo tube 530B into lumen 610. Retention dimple 625 is configured to engage and retain a cooperating feature (e.g., an exterior surface and an anchor, an anchor end, and / or a suture guide (e.g., suture guide 425)) of a suture anchor, such as the suture anchors included in one or more of the anchor strips disclosed herein (e.g., suture anchor strips 100, 200, 300, and / or 400).

[0091] FIG. 7A provides a side perspective view and FIG. 7B provides a crosssection view of a third hypo tube 530C with a non-circular (e.g., ovoid) cross-sectional shape along its length. Third hypo tube 530C includes a lumen 710, a notch 715, and an active tip 725 and may be configured to accept insertion of and cooperation with breakaway anchor strip with an ovoid cross section 200 as shown in, for example, the cross-section of FIG. 7C, which shows breakaway anchor strip with an ovoid cross section 200 seated within lumen 710.

[0092] FIG. 7D provides a side perspective view and FIG. 7E provides a crosssection view of a fourth hypo tube 530D with a non-circular (e.g., triangular) cross-sectional shape along its length. Fourth hypo tube 530D includes a lumen 760, a notch 755, and an active tip 775 and may be configured to accept insertion of and cooperation with breakaway anchor strip with a triangular cross section 300 as shown in, for example, the cross-section of FIG. 7F, which shows breakaway anchor strip with a triangular cross section 300 seated within lumen 760.

[0093] The non-circular shape of third and / or fourth hypo tubes 530C and / or 530D may facilitate stabilization of the anchor(s) and / or breakaway anchor strip(s) seated within lumen 710 or 760, respectively, by, for example, preventing rotational (e.g., twisting or swaying) of the anchor(s) and / or breakaway anchor strip(s) seated within lumen 710 or 760 during use. This helps to keep the anchor(s) and / or breakaway anchor strip(s) seated within lumen 710 or 760 oriented in a uniform and set manner, which may increase ease and / or predictability of use.

[0094] In some embodiments, hypo tube 530 may reside within and / or extend from a catheter coupled to an endoscope. In these embodiments, the catheter may be used to deliver an active end of the hypo tube as well as one or more additional tools, devices, or substances (e.g., a medical fluid such as a pharmaceutical and / or dye) to target tissue. Additionally, or alternatively, a catheter may be configured to assist with target tissue grasping and / or holding. For example, FIG. 8A provides a side view of a delivery catheter with a corkscrew extension 800 that includes a catheter tube 805 with a central lumen 810 running along its length and a corkscrew extension 835 that includes a substantially linear portion 825 that extends away from an end of delivery catheter 805 and a cork-screw, or spiral, portion 820 that extends in a spiral fashion from substantially linear portion 825. A terminating end of spiral portion 820 may be tapered or sharpened into a tip configured to puncture, engage, 80 or cut tissue. A shape of spiral portion 820 may be configured to allow for passage of a portion hypo tube 530 therethrough as shown in, for example, FIG. 8D so that an anchor 110 may be deployed into / past tissue 850 so that it may be seated and anchor the suture within tissue 850. An example of what seated anchor 110 looks like after deployment is shown in FIG. 13C and discussed herein.

[0095] During use, delivery catheter 805 may be positioned proximate to target tissue 801 so that the tip of spiral portion 820 may puncture or otherwise engage withtarget tissue 850 as shown in FIG. 8A. Then delivery catheter 805 may be rotated so that more of spiral portion 820 is pushed through, and engages, the target tissue so that it may be held in place relative to delivery catheter 805 as shown in FIG. 8B. Then, hypo tube 530 may be advanced down (as oriented in FIG. 8A) lumen 810 and into the target tissue through the opening in spiral portion 820 as shown in FIG. 8C and an anchor (e.g., an anchor of a breakaway anchor strip disclosed herein) and / or suture may be placed within the target tissue as, for example, shown and described herein.

[0096] In another example, FIG. 9 provides a side view of a delivery catheter with a plurality of grasping hooks 900 that includes a catheter tube 905 with a central lumen 910 running along its length and a plurality of fixed and / or retractable / extendible grasping hooks 920 positioned proximate to and / or extending from an active end of catheter tube 905. Grasping hooks 920 may be configured to puncture, or otherwise engage with, target tissue (e.g., target tissue 850) so that it may be held in place relative to catheter tube 905 in a manner similar to, for example, spiral portion 820. Then, hypo tube 530 may be advanced down lumen 910 and into the target tissue so that a tip of hypo tube 530 may be inserted into target tissue 850 and an anchor (e.g., an anchor of a breakaway anchor strip disclosed herein) and / or suture may be placed within the target tissue.

[0097] In yet another example, FIG. 10 provides a side view of a delivery catheter 1000 with a central lumen 1010 large enough to accommodate both hypo tube 530 and a pair of micro-forceps 1030 that extend from a wire 1020. Micro-forceps 1030 may be used to grab and hold target tissue (e.g., target tissue 850) while hypo tube 530 is advanced down lumen 1010 so that a tip of hypo tube 530 may be inserted into the target tissue 850 and an anchor (e.g., an anchor of a breakaway anchor strip disclosed herein) and / or suture may be placed within the target tissue.

[0098] FIG. 11A is a side view of an assembly 1100 of an endoscope 1101 and breakaway anchor strip 100, 200, 300, or 400. Endoscope 1101 includes body 520, a handle 1110, and hypo tube 530. Handle 1110 includes an opening 1120 like opening 510 that is in communication with channel 535, which extends through handle 1110 and body 520 and in communication with lumen 610 of hypo tube 530. In preparation for use, an assembly of breakaway anchor strip 100, 200, 300, or 400 and a suture (e.g.,suture 150 or 510) may be inserted into opening 1120 and may travel through channel 535 to stop (via, for example, retention wedge 620 and / or retention dimple 625) within lumen 610 until an anchor of breakaway anchor strip 100, 200, 300, or 400 is in position relative to target tissue or is otherwise ready for deployment. In some embodiments, pushrod 170, 240, 340, or 415 of breakaway anchor strip 100, 200, 300, or 400 may extend through channel 535 to opening 1120.

[0099] At times, a medical fluid (e.g., dye, contrast, saline, medication, etc.) may be added to channel 535 via, for example, injection or poring the medical fluid into opening 1120 for communication through channel 535 to breakaway anchor strip 100, 200, 300, or 400 and, eventually, target tissue via the open end of hypo tube 530.Additionally, or alternatively, the medical fluid may flow through a lumen, channel, and / or opening within breakaway anchor strip 100, 200, 300, or 400, such as channel 120, lumen 207, lumen 247, lumen 307, or lumen 347 for eventual delivery to target tissue. [000100] In some embodiments, pushrod 170, 240, 340, or 415 may include one or more openings, or fenestrations, configured to facilitate flow of medical fluid through channel 535, breakaway anchor strip 100, 200, 300, or 400 and / or pushrod 170, 240, 340, or 415. Exemplary fenestrations 1130 are shown in an exemplary pushrod 1140 that extends from opening 1120 as shown in FIG. 11 B.[000101] FIG. 12 provides a flowchart illustrating an exemplary process 1200 of using one or more breakaway anchor strips, such as the breakaway anchor strips disclosed herein to suture target tissue. Process 1200 may be performed by, for example, robot, a surgeon, and / or a combination thereof using an endoscopic device like the endoscopic devices disclosed herein.[000102] Initially, the hypo tube (e.g., hypo tube 530, 530A, 530B, 530C, or 530D) of an endoscope may be prepared for use by loading an assembly of one or more breakaway anchor strips (e.g., breakaway anchor strip 100, 200, 300, or 400) threaded, or coupled to, one or more respective suture(s) (e.g., suture 150 or 510) therein into a channel (e.g., channel 535) of an endoscope (step 1205). The channel of the endoscope may be in communication with an opening (e.g., 510 or 1120) and a lumen of the hypo tube so that an assembly of a breakaway anchor strip and a suture may be inserted into the opening and slide through the channel until it reaches an active end ofthe hypo tube. In some cases, the breakaway anchor strip may be held in place by a retention feature of the hypo tube (e.g., retention dimple 625 and / or retention wedge 620) until it is ready for deployment into target tissue. Optionally, in step 1205, a pushrod (e.g., pushrod 170, 240, 340, or 415) may extend through channel and exit the opening.[000103] At times, execution of step 1205 may include loading a plurality of breakaway anchor strips into an endoscope and, when a plurality of breakaway anchor strips are loaded into the hypo tube, each breakaway anchor strip may have its own suture (i.e., an independent suture specific to a breakaway anchor strip of the plurality of breakaway anchor strips) and / or a single strand of suture may run through two or more breakaway anchor strips. For the purposes of brevity, process 1200 will be discussed as if only one breakaway anchor strip is being used although it will be understood that the explanation of the steps of process 1200 may apply when a plurality of breakaway anchor strips are used.[000104] In some embodiments, when step 1205 is executed, a first portion of the suture may extend through the breakaway anchor strip via, for example, one or more holes therein like holes 125, lumen like lumen 207, 247, 307, and 347, and / or a suture guide like suture guide 425 and a second portion, or end, may extend through the channel and / or the pushrod to exit the endoscope opening. Optionally, in step 1210, the second portion of the suture may be attached to, or wound around a spool of, an endoscope handle (e.g., an anchor deployment handle) like handle 515 so that it is, for example, engaged with a tensioning device.[000105] After step 1205 and, optionally, step 1210, an assembly of the endoscope, breakaway anchor strip(s), and suture(s) may be ready for use so that an active end of the hypo tube may be placed in a desired position proximate to target tissue (e.g., target tissue 850) of a patient (step 1215). Optionally, a medical fluid (e.g., dye, medication, saline, etc.) may be added to the endoscope’s channel and / or breakaway anchor strip(s) to, for example, assist with visualization, irrigation, and / or treatment of the target tissue (step 1220) as, for example, shown in FIGs. 11A and 11 B and described herein.[000106] In step 1225, an anchor of the breakaway anchor strip may be deployed on and / or within the target tissue. In some embodiments, step 1225 may be executedby exerting force (e.g., a force sufficient to push the anchor past any retention features presenting within a lumen of the hypo tube) onto the pushrod, thereby pushing an anchor of the breakaway anchor strip through and out of the hypo tube into the target tissue. Once the anchor is in a desired position, tension may be applied to the suture coupled to the deployed anchor causing it to break away, or detach, from the breakaway anchor strip and sit within, or on, patient tissue, thereby anchoring the suture within / on the tissue. At times, the tension may be applied to the suture via activating (e.g., turning or pressing) a tensioning mechanism (e.g., tensioning mechanism 540 and / or spool 545) to create sufficient tension on suture to cause the deployed anchor to break away from the breakaway anchor strip. Next, the active end of the hypo tube may be removed from suturing / desired position and it may be determined whether or not the suturing is complete (step 1235). When the suturing is not complete, steps 1215, 1220, 1225, and / or 1230 may be repeated. Optionally, suturing may be complete when a cinching anchor (e.g., cinching anchor 435) is placed within tissue and a cutting anchor (e.g., cutting anchor 440) is seated therein (step 1240). Seating of the cutting anchor within the cinching anchor may serve to cut to suture so that any remaining, excess, suture may be removed from the target tissue and / or patient.[000107] FIGs. 13A-13F provide an example of how steps of process 1200 may be executed using an assembly of suture 150 and breakaway anchor strip 100, hypo tube 530 (which includes hypo tube 530A, 530B, 530C, and 530D), and endoscope 500 or 1101. After the assembly of suture 150 and breakaway anchor strip 100 is loaded into hypo tube 530, an assembly endoscope 500 or 1101 , hypo tube 530, suture 150 and breakaway anchor strip 100 is positioned proximate to a first target tissue 530A and the active tip of hypo tube 530 is pushed through the first position of target tissue 530A until the active tip is through the first position of target tissue 530A as shown in the cutaway view of FIG. 13A (step 1215). Then, anchor strip 100 is pushed through hypo tube 530 and out of the active tip until it is properly positioned beyond the first position of target tissue 530A as shown in the cutaway view of FIG. 13B (step 1225). Next, tension may be applied to suture 150 so that first anchor 110A bends in a counter-clockwise (as oriented in the figure) direction and breaks away from breakaway anchor strip 100 (step 1225). Further tension may be applied to suture 150 so that first anchor 110A changesorientation by approximately ninety degrees to rest approximately parallel to the first position of target tissue 530A as shown in FIG. 13C (step 1225).[000108] Once in the position shown in FIG. 13C, first anchor 110A is fully seated second anchor 11 OB may be placed by repositioning the assembly endoscope 500 or 1101 , hypo tube 530, suture 150 and breakaway anchor strip 100 proximate to a second target tissue 530B and pushing the active tip of hypo tube 530 through the second position of target tissue 530B until the active tip is through the second position of target tissue 530B as shown in the cutaway view of FIG. 13D (repeat of step 1215). Then, anchor strip 100 is pushed through hypo tube 530 and out of the active tip until it is properly positioned beyond the second position of target tissue 530B as shown in the cutaway view of FIG. 13E (repeat of step 1225). Next, tension may be applied to suture 150 so that second anchor 110B bends in a counter-clockwise (as oriented in the figure) direction and breaks away from breakaway anchor strip 100 (repeat of step 1225). Further tension may be applied to suture 150 so that second anchor 110B changes orientation by approximately ninety degrees to rest approximately parallel to the second position of target tissue 530B as shown in FIG. 13F (repeat of step 1225).

Claims

CLAIMSWe claim:1 . A breakaway anchor strip comprising: a body comprising: a first anchor; a second anchor, the second anchor being connected to the first anchor by a first tab positioned on a first side of the body and separated from the first anchor by a first groove, the first grove being positioned on a second side of the body; a third anchor, the third anchor being connected to the second anchor by a second tab positioned on the second side of the body and separated from the second anchor by a second groove, the second grove being positioned on the first side of the body; and a pushrod in physical communication with the body.

2. The breakaway anchor strip of claim 1 , further comprising: a suture extending through the first, second, and third anchors.

3. The breakaway anchor strip of claim 2, wherein when force is applied to the suture, the first tab breaks, thereby separating the first anchor from the second anchor so that it may remain at a position within target tissue of a patient.

4. The breakaway anchor strip of any of claims 1 -3, wherein the breakaway anchor strip has a non-circular cross-sectional shape along a plane perpendicular to a length of the breakaway anchor strip.

5. The breakaway anchor strip of claim 4, wherein the non-circular cross-sectional shape is at least one of an ovoid shape, a triangular shape, and an irregular shape.

6. The breakaway anchor strip of claim 4 or 5, wherein the non-circular cross-sectional shape is configured to fit within and cooperate with a hypo tube that has a corresponding non-circular cross-sectional shape.

7. The breakaway anchor strip of any of the above claims, wherein the body and the pushrod has a central lumen.

8. The breakaway anchor strip of any of the claims 1 , 3, 4, 5, 6, or 7, wherein the third anchor is a cinching anchor comprising a lumen sized, positioned, and configured toaccept and retain an extension of a cutting anchor therein, the breakaway anchor strip further comprising: a suture extending through the first, second, and third anchors; and the cutting anchor, the cutting anchor comprising the extension and a cutting edge configured to cut the suture when the extension is positioned within the lumen of the cinching anchor.

9. The breakaway anchor strip of any of the above claims, wherein the pushrod is configured to extend through a length of an endoscope.

10. The breakaway anchor strip of any of the above claims, wherein the pushrod has a lumen and the body has a lumen in communication with the lumen of the pushrod, the lumens of the body and pushrod being configured to allow communication of medical fluid therethrough.11 . The breakaway anchor strip of any of the above claims, wherein the pushrod has a lumen and one or more fenestrations open to the lumen, the one or more fenestrations being configured and positioned to allow communication of a medical fluid from the lumen of the pushrod into at least one of a channel of an endoscope in which the pushrod is positioned and a lumen of a hypo tube in which the breakaway anchor strip is positioned.

12. A delivery catheter of an endoscope comprising: a tube with a sidewall with a central lumen and a first end physically coupled to the endoscope, the central lumen being configured to be in communication with a central channel of the endoscope; and a corkscrew extension physically coupled to a second end of the tube, the corkscrew extension including a pointed tip configured to puncture tissue.

13. The delivery catheter of claim 10, wherein the central lumen is sized and configured to accept insertion of an assembly of a hypo tube and a breakaway anchor strip therein, the breakaway anchor strip being resident within a lumen of the hypo tube.

14. The delivery catheter of claim 12, wherein an external diameter of the hypo tube is smaller than an internal diameter of the tube so that a medical fluid may travel through the central lumen of the tube and be communicated to the tissue.

15. The delivery catheter of claim 12, wherein the breakaway anchor strip comprises:a body comprising a plurality of anchors frangibly connected to one another; a suture threaded through the plurality of anchors; and a pushrod in physical communication with the body.

16. The delivery catheter of claim 12, 13, or 14, wherein an external diameter of the breakaway anchor strip is smaller than an internal diameter of the hypo tube so that a medical fluid may travel through the hypo tube and be communicated to the tissue.

17. The delivery catheter of any of claims 12-15, wherein the breakaway anchor strip includes a lumen configured to allow medical fluid to flow therethrough and be communicated to the tissue.

18. The delivery catheter of claim 11 or 12, wherein the corkscrew extension is operable to engage tissue so that the tissue may be secured against the second end of the delivery catheter while an anchor from the breakaway anchor strip is deployed into the tissue.

19. A breakaway anchor strip comprising: a body having an ovoid cross-sectional shape and comprising a plurality of anchors frangibly connected to one another, each of the anchors being configured to allow a suture to pass therethrough; and a pushrod in physical communication with the body.

20. The breakaway anchor strip of claim 14, wherein the pushrod has an ovoid cross- sectional shape.

21. The breakaway anchor strip of claim 14 or 15, further comprising: a cinching anchor comprising a lumen sized, positioned, and configured to accept and retain an extension of a cutting anchor therein; a suture extending through the plurality of anchors and ;the cinching anchor; and the cutting anchor, the cutting anchor comprising the extension and a cutting edge configured to cut the suture when the extension is positioned within the lumen of the cinching anchor.

22. The breakaway anchor strip of any of claims 14-16, wherein the breakaway anchor strip is sized and configured to fit within a hypo tube with a corresponding ovoid cross-sectional shape.

23. A breakaway anchor strip comprising:a body having a triangular cross-sectional shape and comprising a plurality of anchors frangibly connected to one another, each of the anchors being configured to allow a suture to pass therethrough; and a pushrod in physical communication with the body.

24. The breakaway anchor strip of claim 18, wherein the pushrod has a triangular cross- sectional shape.

25. The breakaway anchor strip of claim 18 or 19, further comprising: a cinching anchor comprising a lumen sized, positioned, and configured to accept and retain an extension of a cutting anchor therein; a suture extending through the plurality of anchors and ;the cinching anchor; and the cutting anchor, the cutting anchor comprising the extension and a cutting edge configured to cut the suture when the extension is positioned within the lumen of the cinching anchor.

26. The breakaway anchor strip of any of claims 18-20, wherein the breakaway anchor strip is sized and configured to fit within a hypo tube with a corresponding triangular cross-sectional shape.

27. A hypo tube configured to cooperate with an endoscope, the hypo tube having an ovoid cross-sectional shape and a central lumen configured to accept insertion of a breakaway anchor strip with a corresponding ovoid cross-sectional shape.

28. The hypo tube of claim 22 further comprising a retention feature positioned within the central lumen, the retention feature being configured to hold the breakaway anchor strip in the hypo tube until a force is applied to the breakaway anchor strip that advances an anchor of the breakaway anchor strip through the hypo tube and into target tissue of a patient.

29. A hypo tube configured to cooperate with an endoscope, the hypo tube having a triangular cross-sectional shape and a central lumen configured to accept insertion of a breakaway anchor strip with a corresponding triangular cross-sectional shape.

30. The hypo tube of claim 22 further comprising a retention feature positioned within the central lumen, the retention feature being configured to hold the breakaway anchor strip in the hypo tube until a force is applied to the breakaway anchor stripthat advances an anchor of the breakaway anchor strip through the hypo tube and into target tissue of a patient.31 .A method of using the breakaway anchor strip of any of the above claims to suture tissue together.

32. The method of claim 31, wherein the tissue is at least one of skin, organ tissue, muscular tissue, ligament tissue, cartilage, and tendon tissue.

33. A method comprising: loading a suture and a breakaway anchor strip assembly into a hypo tube extending from an endoscope so that a first portion of the suture extends through the hypo tube and a channel of the endoscope, the breakaway anchor strip including an anchor and an exploded assembly of a cinching anchor and a cutting anchor; attaching a second portion of the suture to a spool of a handle of the endoscope; inserting the hypo tube into a first target tissue and advancing the anchor into the first target tissue; turning the spool to exert tension on the suture, wherein the tension on the suture separates the anchor from the breakaway anchor strip; removing the hypo tube from the first target tissue and inserting the hypo tube into a second target tissue proximate to the first target tissue and advancing the exploded assembly of the cinching anchor and the cutting anchor into the second target tissue; turning the spool to exert tension on the suture, wherein the tension on the suture pushes an extension of the cutting anchor into a corresponding lumen of the cinching anchor, thereby cinching the sutured tissue closed and cutting the suture so that excess suture may be removed from the target tissue.

34. The method of claim 33, further comprising: adding medical fluid to the channel of the endoscope for communication to the target tissue via a lumen of at least one of the breakaway anchor strip and the hypo tube.

35. The method of claim 33 or 34, wherein the cutting anchor is frangibly attached to a pushrod that extends through the channel of the endoscope, the method further comprising:turning the spool to exert tension on the suture to separate the cutting anchor from the pushrod.

36. The method of claim 33, 34, or 35, wherein the cutting anchor is frangibly attached to a pushrod that extends through the channel of the endoscope and advancement of the anchor into the first target tissue is facilitated by exerting a force on the pushrod.

37. A method comprising: loading a suture and a breakaway anchor strip assembly into a hypo tube extending from an endoscope, the breakaway anchor strip including an anchor and an exploded assembly of a cinching anchor and a cutting anchor; inserting the hypo tube into a first target tissue and advancing the anchor into the first target tissue; exerting tension on the suture, wherein the tension on the suture separates the anchor from the breakaway anchor strip; removing the hypo tube from the first target tissue and inserting the hypo tube into a second target tissue proximate to the first target tissue and advancing the exploded assembly of the cinching anchor and the cutting anchor into the second target tissue; exerting tension on the suture, wherein the tension on the suture pushes an extension of the cutting anchor into a corresponding lumen of the cinching anchor, thereby cinching the sutured tissue closed and cutting the suture so that excess suture may be removed from the target tissue.

38. The method of claim 34, further comprising: adding medical fluid to the channel of the endoscope for communication to the target tissue via a lumen of at least one of the breakaway anchor strip and the hypo tube.

39. The method of claim 34 or 35, wherein the cutting anchor is frangibly attached to a pushrod that extends through the channel of the endoscope, the method further comprising: exerting tension on the suture to separate the cutting anchor from the pushrod.

Images