Patent Description:
Suturing is used during a wide variety of endoscopic procedures, such as closing a wound, anchoring a stent or other implant, or shorting curvature in the stomach. Several types of sutures and devices for implantation and extraction have been developed. In some approaches, suturing is performed by repeatedly passing a sharp suture needle attached to a length of suture material through portions of tissue to be sutured together. The free ends of the suture material are then tied together to complete the suturing procedure.

Many endoscopic procedures pull tissue together and hold the tissue in a new configuration. However, reconfiguring and constraining tissue generates tension between the tissue and the suture. While current sutures and suturing approaches may provide an adequate temporary solution to holding tissue, over time the force required to hold the tissue in place becomes too great to sustain an equilibrium. As a result, when the tissue relaxes the suture can tear through the tissue.

<CIT> discloses systems, devices and methods for endoscopic procedures involving accessing and manipulating tissues beyond the capabilities of traditional endoscopic instruments. Embodiments of the systems include an elongated main body which has one or more independently shape-lockable sections and a variety of instruments which are either built into the main body or advanceable through lumens which extend through the main body. Such instruments may include scopes, suction instruments, aspiration instruments, tool arms, plicators, needles, graspers, and cutters. The ability to steer and shape-lock specific sections of the main body enables access to target locations which are typically challenging to reach and provides a stabilized platform to perform a desired procedure at the target location. <CIT> discloses integrated systems and associated method for manipulating tissues and anatomical or other structures in medical applications for the purpose of treating diseases or disorders or other purposes. In one aspect, the system includes a delivery device configured to deploy and implant anchoring devices for such purposes. <CIT> discloses an apparatus that includes an elongated member configured for transoral placement into a stomach, and a distal end effector including first and second members configured to engage stomach tissue, e.g., tissue beyond the esophageal junction. The first and second members are movable relatively toward one another generally in a first plane, and the distal end effector is movable relative to the elongated member in a second plane generally transverse to the first plane. A third member of the distal end effector is configured to engage stomach tissue. The third member is movable in a distal direction relative to the first and second members. A tissue securement member of the apparatus is coupled to at least one of the first and second members for securing together tissue engaged thereby. The tissue securement member includes first and second parts, a suture attached to the first part, and a securing element attached to the suture and configured for engagement with the second part when the first and second members move relatively toward one another to engage tissue, to thereby secure the second part to the first part. <CIT> discloses a ligature and suture device for medical application that ligatures or sutures biomedical tissue that has been suctioned by a suction device using a suturing member. The ligature and suture device includes an insertion portion having a lumen into which an endoscope can be inserted, and a distal end portion that is connected to the lumen and in which at least one side aperture is provided, at least one hollow needle that is able to support inside itself the suturing member, and that is placed inside the insertion portion such that a tip of the hollow needle is able to move between a first position, which is on a base end side of the side aperture, and a second position, which is on a distal end side of the side aperture, an operating section that performs an operation to move the needle, and at least one pledget that can be penetrated by the needle, and that is placed in a vicinity of the distal end of the side aperture so as to be freely removable from the distal end portions. <CIT> discloses a surgical suturing instrument that has a needle which traverses a tissue receiving gap and picks up suture distal to the gap. This invention provides an automated mechanism enabling the suture to be removed from the needle after the needle is retracted proximal to the tissue gap. This mechanism provides enhanced device reloading and other potential uses. It is with the above considerations in mind that the improvements of the present disclosure may be useful.

The present disclosure in its various embodiments relates generally to apparatuses, devices, and methods for redistributing force at the tissue-suture interface to increase long-term effectiveness of an endoscopic suturing procedure.

Furthermore, some of the figures include cross-sectional views in the form of "slices", or "near-sighted" cross-sectional views, omitting certain background lines or features otherwise visible in a "true" cross-sectional view, for illustrative clarity. In the figures:.

The present disclosure is not limited to the particular embodiments described herein. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs.

Embodiments herein disclose endoscopic tissue suturing apparatuses, devices, and methods for increasing force distribution at a suture-tissue interface. Those skilled in the art will appreciate that while the approaches of the present disclosure will herein be described with reference to suturing an area of the stomach, the approaches may be utilized in other gastrointestinal transluminal procedures, and may be introduced transorally as well as transanally.

Although non-limiting, approaches of the present disclosure may be effective for treating gastroesophageal reflux disease (GERD) by performing procedures such as partial circumferential endoscopic mucosal resection (EMR) or submucosal dissection (ESD) of a patient's gastrointestinal tract.

Turning now to <FIG>, a tissue suturing apparatus (hereinafter "apparatus") <NUM> according to embodiments of the present disclosure will be described. As shown, the apparatus <NUM> includes a tissue suturing device (hereinafter "device") <NUM> extending from a distal end <NUM> of a scope, such as an endoscope <NUM>. The device <NUM> may include a head or cap <NUM> having a fixed end <NUM> directly coupled to the endoscope <NUM>, and a free end <NUM> opposite the fixed end <NUM>. In some embodiments, the cap <NUM> may be coupled to the endoscope <NUM> using a variety of techniques, such as by mechanical fasteners, glue, suture, press fit, tape, overmolding, etc. In other embodiments, the dispenser cap may be integrally formed with the endoscope.

During use, a needle <NUM> may be passed back and forth between the fixed end <NUM> and the free end <NUM> along a longitudinal axis, the needle <NUM> including one or more pointed tips for puncturing a target tissue <NUM> with each pass. In some embodiments, a tissue grasper <NUM> may be delivered through a channel <NUM> of the cap <NUM> to engage the target tissue <NUM>, bringing the target tissue <NUM> into a suture cavity <NUM> located between the fixed end <NUM> and the free end <NUM>.

The device <NUM> includes a deployment device <NUM> containing a plurality of tissue supports (not shown) therein. As will be explained in greater detail below, the tissue supports may be added between a suture and the target tissue <NUM> during one or more passes of the needle <NUM>. In some embodiments, the deployment device <NUM> may be coupled to the free end <NUM> of the device <NUM>, positioned generally opposite the fixed end <NUM>.

Turning now to <FIG>, an example deployment device <NUM> according to embodiments of the present disclosure will be described. As shown, the deployment device <NUM> may be a cartridge including a housing <NUM> containing a plurality of tissue supports <NUM> therein. The housing <NUM> may include an interior channel <NUM> and a biasing device <NUM> (e.g., a spring) for biasing the plurality of tissue supports <NUM> through the interior channel <NUM>. In some embodiments, the plurality of tissue supports <NUM> are solid, flexible components arranged end-to-end. During suturing, a needle <NUM> enters a suture cavity <NUM>, puncturing an exposed tissue support 240A of the plurality of tissue supports <NUM>. As the exposed tissue support 240A is brought away from the deployment device <NUM>, attached to the needle <NUM>, the biasing device <NUM> may cause the next tissue support of the plurality of tissue supports <NUM> to enter the suture cavity <NUM> for subsequent engagement by the needle <NUM> on the next pass. One or more of the plurality of tissue supports <NUM> may be added every time the needle <NUM> passes through the tissue such that the interface between a suture and the tissue becomes more robust as the procedure continues. In some embodiments, the deployment device <NUM> may include a rigid plate <NUM> positioned behind the exposed tissue support 240A to prevent the needle <NUM> from extending into the housing <NUM>. Furthermore, the deployment device <NUM> may include an overhang <NUM>, which may keep the exposed tissue support 240A aligned within the suture cavity <NUM>.

Turning now to <FIG> which discloses an embodiment according to the invention, various deployment devices according to embodiments of the present invention will be described in greater detail. As shown, a deployment device <NUM> includes a plurality of tissue supports <NUM> stacked atop one another within a housing <NUM>. The deployment device <NUM> includes a cover <NUM> extending across the housing <NUM>. In the embodiment of <FIG>, the cover <NUM> may include one or more membranes <NUM> extending across the housing <NUM>. The membrane(s) <NUM> may define a slot or opening <NUM> to permit access to the plurality of tissue supports <NUM> by a needle (not shown). The membrane(s) <NUM> may be durable enough to hold the plurality of tissue supports <NUM> in place within the deployment device <NUM>, yet flexible enough to allow an exposed tissue support of the plurality of tissue supports <NUM> to be pulled from the deployment device <NUM> by the needle.

In the embodiment of <FIG>, the cover <NUM> may include a plurality of components, such as slats <NUM> extending across a frame <NUM> of the housing <NUM> to hold the plurality of tissue supports <NUM> in place. In various examples, the plurality of slats <NUM> may be oriented laterally, longitudinally and/or diagonally. As shown, the plurality of slats <NUM> may define an opening <NUM> to allow a needle to enter the deployment device <NUM> and puncture an exposed tissue support of the plurality of tissue supports <NUM>. The exposed tissue support may then be folded or bent, and then pulled through the opening <NUM>.

As shown in <FIG>, a deployment device <NUM> may include a mandrel <NUM> within a housing <NUM>. In some embodiments, the mandrel <NUM> may be a tubular shaped component defining a central channel <NUM> therein. As will be described in greater detail below, the central channel <NUM> permits a needle to enter the deployment device <NUM> and retain one or more of a plurality of tissue supports <NUM>. In this embodiment, the plurality of tissue supports <NUM> may be cylindrical washers disposed concentrically around an exterior surface <NUM> of the mandrel <NUM>. Furthermore, the plurality of tissue supports <NUM> may elastically expand to fit the mandrel <NUM> in the deployment device <NUM>. After deployment, the plurality of tissue supports <NUM> may shrink or constrict to effectively close around a suture.

Turning now to <FIG>, cross-sectional views demonstrating operation of the deployment device <NUM> of <FIG> will be described in greater detail. As shown in <FIG>, the deployment device <NUM> contains a plurality of tissue supports <NUM> (e.g., four) disposed around the mandrel <NUM>. The deployment device <NUM> may operate with a needle shuttling system <NUM>, which may include two or more nested hypo-tubes, such as an inner tube <NUM> and an outer tube <NUM> operable to shuttle a needle <NUM> and a suture <NUM> back and forth through a target tissue <NUM>. In some embodiments, a set of prongs <NUM> may extend from the inner tube <NUM>. In various examples, the inner tube <NUM> and the outer tube <NUM> may move together or independently.

As shown in <FIG>, the inner tube <NUM> of the needle shuttling system <NUM> may be passed distally over the needle <NUM> to interact with the deployment device <NUM>. For example, the prongs <NUM> on the end of the inner tube <NUM> may be deformable to fit alongside/adjacent the plurality of tissue supports <NUM>. In some embodiments, a depth that the prongs <NUM> enter the deployment device <NUM> can be controlled at the handle (not shown) by an operator. In other embodiments, the prongs <NUM> merely abut a proximal end <NUM> of the deployment device <NUM>. Although not shown, the deployment device <NUM> may include a spring system (e.g., one or more springs, or other biasing mechanisms) incorporated into a distal end <NUM> of the deployment device <NUM> to continually or selectively push the plurality of tissue supports <NUM> to the proximal end <NUM> for engagement with the prongs <NUM>. For example, in response to the needle being received in the deployment device <NUM>, a proximal-most tissue support <NUM> may be deployed onto the prongs <NUM>.

When the needle shuttling system <NUM> is retracted from the deployment device <NUM>, an outermost tissue support 440A of the plurality of tissue supports <NUM> may be removed from the mandrel <NUM>, for example, as shown in <FIG>. In some embodiments, the outermost tissue support 440A may extend around the suture <NUM> and remain on the prongs <NUM> while the inner tube <NUM> moves farther away from the deployment device <NUM>. The outermost tissue support 440A may contract, thereby remaining on the prongs <NUM> by tension. Furthermore, the prongs may include one or more curved ends <NUM> (e.g., curved radially outward) to prevent the outermost tissue support 440A from sliding off the prong <NUM>.

Next, as shown in <FIG>, the outer tube <NUM> of the needle shuttling system <NUM> may be advanced distally in relation to the inner tube <NUM>, pushing the outermost tissue support 440A off the prongs <NUM> and onto the suture <NUM>, for example, between the needle <NUM> and the target tissue <NUM>. The position of the outer tube <NUM> can then be reset in relation to the inner tube <NUM> so the needle shuttling system <NUM> is ready for another needle pass. In some embodiments, a tissue support may not be added in between each suture pass. Furthermore, it will be appreciated that the number of tissue supports deployed depends on the needs of the procedure, physician, and/or the capacity of the deployment device <NUM>. Embodiments herein are not limited in this context.

Turning now to <FIG>, a tissue suturing device (hereinafter "device") <NUM> according to embodiments of the present disclosure will be described. The device <NUM> may include a head or cap <NUM> having a fixed end <NUM> coupleable with an endoscope (not shown), and a free end <NUM> opposite the fixed end <NUM>. In some embodiments, the cap <NUM> may be integrally formed with an endoscope or other instrument. During use, a needle <NUM> and a suture <NUM> may be passed back and forth between the fixed end <NUM> and the free end <NUM> along a longitudinal axis, puncturing a target tissue (not shown) positioned in a suture cavity <NUM>.

As further shown, the device <NUM> may include a deployment device <NUM> coupled to the fixed end <NUM> of the cap <NUM>. In this embodiment, the deployment device <NUM> may include a plurality of tissue supports 540A-540B extending around a collar <NUM>. During assembly, the suture <NUM>, which is connected to the needle <NUM>, may be threaded between tissue support 540A and tissue support 540B to allow distal most positioned tissue support 540A to be placed between the needle <NUM> and the tissue.

As shown, the collar <NUM> may secure the device <NUM> onto a distal end of the endoscope. In other embodiments, the collar <NUM> is integrally formed with the endoscope or other tubular instrument. Although non-limiting, each of the plurality of tissue supports 540A-540B may be a washer-shaped support disposed around an exterior of the collar <NUM>. The collar <NUM> may define a collar opening <NUM> aligned with a working channel of the endoscope. The needle <NUM> may pass in and out of the collar opening <NUM> during suturing, as will be described in greater detail below. While situated on the collar <NUM>, the plurality of tissue supports <NUM> are stretched for deployment over the needle <NUM> and the suture <NUM>. As the suture <NUM> is pulled at the proximal handle of the device <NUM>, each of the plurality of tissue supports <NUM> may be deployed separately. Advantageously, the plurality of tissue supports 540A-540B may be deployed on opposite sides of the target tissue being tensioned together, for example, after the operator has passed the needle <NUM> through the target tissue a desired number of times but before the suture <NUM> is cinched.

In some embodiments, the plurality of tissue supports <NUM> are deployed using an additional suture (not shown). For example, the additional suture may be connected to one or more of the plurality of tissue supports 540A-540B. As the additional suture is pulled towards the fixed end <NUM>, the additional suture may release distal most positioned tissue support 540A from the collar <NUM>. In some embodiments, the collar <NUM> may include an aperture (not shown) through a sidewall thereof, the aperture allowing the additional suture to exit from the central bore of the collar <NUM>. Having the plurality of tissue supports 540A-540B situated on the collar <NUM> with the additional suture may allow the needle <NUM> to shuttle back and forth normally as many times as the operator needs.

Turning now to <FIG>, operation of the device <NUM> according to embodiments of the present disclosure will be described in greater detail. In <FIG>, the needle <NUM> and the suture <NUM> may be passed through a first piece of the target tissue <NUM>, and then through a second piece of the target tissue <NUM>, as demonstrated in <FIG>. As shown in <FIG>7F, the needle <NUM> may then be pulled through the collar <NUM> of the deployment device <NUM> and into a working channel <NUM> of an endoscope <NUM>. In some embodiments, the suture <NUM> may extend around just the distal most positioned tissue support 540A. During deployment, as demonstrated in <FIG>, the distal most positioned tissue support 540A may be released from the deployment device <NUM> and then brought into position on one side of the target tissue <NUM>. A second tissue support 540B may then be released from the deployment device <NUM>, and then brought into position on an opposite side of the target tissue <NUM>, as shown in <FIG>. In some embodiments, the endoscope <NUM> (<FIG>) may be move away from the target tissue 522to bring the needle <NUM> into contact with one side of the target tissue <NUM>, while the suture <NUM> pulled to deploy the second tissue support 540B onto the suture <NUM>. Finally, as shown in <FIG>, the suture <NUM> may be pulled tight and secured, for example, using a cinching device <NUM>. The cinching device <NUM> may bring the distal most positioned tissue support 540A and second tissue support 540B on opposite sides of the target tissue <NUM> closer together by pulling the suture <NUM> to bring the needle <NUM> towards the deployment device <NUM>.

Turning now to <FIG>, a suture <NUM> according to embodiments of the present disclosure will be described. The suture <NUM> may include a rigid or semi-rigid tip <NUM> operable to pierce a target tissue <NUM>. The rigid tip <NUM> may be connected to a plurality of flexible strands or filaments <NUM>. As shown in <FIG>, the suture <NUM> may initially pass through the target tissue <NUM> in a direction demonstrated by arrow <NUM>. In this configuration, the filaments are generally straight and elongated. As demonstrated in <FIG>, the suture <NUM> may include one or more retention wires <NUM> surrounding the filaments <NUM>. The retention wires <NUM> may be used to pull the suture <NUM> back towards the target tissue <NUM>, for example, in a direction shown by arrow <NUM> in <FIG>. Pulling the suture <NUM> toward the target tissue <NUM> causes the filaments <NUM> to extend radially, creating a malecot configuration against a surface <NUM> of the target tissue <NUM>. As shown in <FIG>, an interface <NUM> between the filaments <NUM> and the target tissue <NUM> may generally have larger area due the expanded configuration of filaments <NUM>. Force is therefore better distributed at the interface <NUM>, making it less likely that the target tissue <NUM> will rupture.

Turning now to <FIG>, a suture <NUM> according to embodiments of the present disclosure will be described. The suture <NUM> may include a rigid tip <NUM> connected to a polymer body <NUM>, wherein the polymer body <NUM> may be rigid or flexible. As shown in <FIG>, the suture <NUM> may initially pass through at an interface <NUM> of the target tissue <NUM> in a direction shown by arrow <NUM>. In this configuration, the polymer body <NUM> is generally straight and elongated. However, as demonstrated in <FIG>, an outer material <NUM> of the polymer body <NUM> may expand or grow radially when it comes into contact with a fluid (not shown), such as water, saline, blood, etc..

In some embodiments the outer material <NUM> of the polymer body <NUM> may be a hydrogel. The term "hydrogel" may indicate a crosslinked, water insoluble, water containing material. Suitable cross-linkable polymers include but are not limited to one or a mixture of polymers selected from the group consisting of polyhydroxy ethyl methacrylate, polyvinyl alcohol, polyacrylamide, poly (N-vinyl pyrrolidone), polyethylene oxide, hydrolysed polyacrylonitrile, polyacrylic acid, polymethacrylic acid, polyethylene amine, alginic acid, pectinic acid, carboxy methyl cellulose, hyaluronic acid, heparin, heparin sulfate, chitosan, carboxymethyl chitosan, chitin, pullulan, gellan, xanthan, carboxymethyl starch, carboxymethyl dextran, chondroitin sulfate, cationic guar, cationic starch as well as salts and esters thereof. The hydrogel produces may have having improved mechanical properties, such as improved stiffness, modulus, yield stress, strength, etc., at the interface <NUM>.

As shown in <FIG>, as the suture <NUM> is retracted, the outer material <NUM> of the polymer body <NUM> begins to bunch. Further retraction of the suture <NUM> towards the target tissue <NUM>, as demonstrated in <FIG>, causes the outer material <NUM> to gather as a bundle along a surface <NUM> of the target tissue <NUM>. The interface <NUM> between the outer material <NUM> and the target tissue <NUM> generally has a larger area due to the expansion of the outer material <NUM>. Force is therefore better distributed at the interface <NUM>, making it less likely that the target tissue <NUM> will rupture.

Turning now to <FIG>, a suture <NUM> according to embodiments of the present disclosure will be described. As shown, the suture <NUM> may include a core <NUM> surrounded by a sheath <NUM>. A portion of the core <NUM> extending outside of the sheath <NUM> may correspond to a tip <NUM> of the suture <NUM>. In some embodiments, the sheath <NUM> is capable of expanding radially from the core <NUM>. Furthermore, the sheath <NUM> may move independent of the core <NUM> to allow for bunching of the sheath, as demonstrated in <FIG>. In this embodiment, the sheath <NUM> may be a continuous or sheet-like covering that bulbs and buckles upon expansion and retraction of the core <NUM>, creating a solid plug-like interface where the suture <NUM> meets a target tissue (not shown). In some embodiments, the sheath <NUM> is disposed concentrically around the core <NUM>.

In the embodiment of <FIG>, a sheath <NUM> of a suture <NUM> may include a plurality of flexible strands. As shown, as a core <NUM> of the suture <NUM> is retracted, the flexible strands bunch-up, expanding to create a mesh-like network with increased surface area. In some embodiments, the sheath <NUM> is disposed concentrically around the core <NUM>.

Turning now to <FIG>, the use of a sprayable adhesive <NUM> applied to an area of target tissue <NUM> according to embodiments of the present disclosure will be described in greater detail. As shown, a sprayable adhesive <NUM> may be delivered through an endoscope <NUM>. The sprayable adhesive <NUM> may be applied to the target tissue <NUM> at each interface <NUM> where the suture <NUM> and the needle <NUM> penetrate the target tissue <NUM>. As a result, the interface <NUM> may be less susceptible to tearing under the pull of the suture <NUM>.

During use, a physician may conduct an endoscopic procedure. The physician may retract a device occupying the working channel (e.g., visualization device) and advance a needle or catheter <NUM>. Once this feature reaches the working channel, a syringe (not shown) with a medical grade, silicone-based spray adhesive, for example, would be coupled to the proximal end of the catheter <NUM> (e.g., via a Luer connector). The syringe may be actuated, forcing the sprayable adhesive <NUM> to eject from the distal end of the endoscope <NUM>. As shown in <FIG>, as the sprayable adhesive sets, the surface of the target tissue <NUM> that a cinch <NUM> and needle <NUM> are in contact with will harden and prevent expansion, thus preventing the cinch <NUM> and/or needle <NUM> from passing through the hole in the target tissue <NUM> at each interface <NUM>.

In the non-limiting embodiment of <FIG>, a curable glue <NUM> (e.g., moisture or UV curable) may be added to a target tissue <NUM> at each end of a suture <NUM> to distribute force applied on an interface <NUM> between the target tissue <NUM> and the suture <NUM>. Due to the flexible nature of the curable glue <NUM> prior to curing, the curable glue <NUM> can more easily pass through the working channel of the endoscope <NUM> and be applied at the target tissue <NUM>. In addition, the curable glue <NUM> may allow the physician to better customize a final shape for the curable glue <NUM> based on the demands of the procedure, location of the wound, his/her preference, etc. For example, as shown in <FIG>, the curable glue <NUM> may be fashioned into one or more cylindrical washers <NUM> each having a central opening <NUM>. As a result, the suture <NUM> (<FIG>) may pass through the central openings <NUM>. Furthermore, use of the curable glue <NUM> also gives the physician the freedom to add additional glue at various points in the procedure, for example, to improve the force distribution as needed pre- or post-suturing. In some embodiments, as shown in <FIG>, the needle <NUM> may remain on top of the curable glue <NUM> following suturing. To improve visibility, the curable glue <NUM> can also be dyed in alternative embodiments.

In the non-limiting embodiment of <FIG>, one or more tubular tissue supports (e.g., washers) <NUM> may be used on opposite sides of a target tissue <NUM>. As shown, the tubular tissue supports <NUM> may include a slot <NUM> through which a suture <NUM> can run, allowing the tubular tissue supports <NUM> to be placed anywhere along the suture <NUM> after the suture <NUM> is threaded through the target tissue <NUM>. In some embodiments, the tubular tissue supports <NUM> may be delivered endoscopically and maneuvered into place using a grasper or similar tool to protect the target tissue <NUM> after the suture <NUM> is placed, but before the suture <NUM> is cinched.

Turning now to <FIG>, tissue supports in the form of one or more elastic elements or spring-loaded wires will be described. As shown, a wire <NUM> may be deployed from an endoscope <NUM> and onto a suture <NUM> as a needle <NUM> and the suture <NUM> traverse through a target tissue <NUM>. In the non-limiting embodiment shown, the wire <NUM> may be a metallic, spring-loaded wire with shape memory, which is preloaded into a delivery catheter of the endoscope <NUM>. As the wire <NUM> is advanced beyond a distal tip of the endoscope <NUM>, it begins to curl. The wire <NUM> may create a hook <NUM> as it begins to curl, the hook being engageable with the suture <NUM> between the cinch <NUM> and the target tissue <NUM>, and/or between the needle <NUM> and the target tissue <NUM>.

Once the suture <NUM> is acquired by the hook <NUM>, the rest of the wire <NUM> may be fed out of the endoscope <NUM>. The wire <NUM> continues to curl until a proximal end is expelled. Use of the wire <NUM> allows for a low-profile during delivery and, once deployed, a large solid surface area for the cinch <NUM> and the needle <NUM> to interface with, thus preventing pull through. In non-limiting embodiments, the wire <NUM> may be made of steel, Nitinol or any other material with a high spring constant. In other embodiments, the wire <NUM> may also take on the profile of a ribbon, which may also increase a contact surface area between the wire <NUM> and the cinch <NUM> and the needle <NUM>.

Alternatively, the wire <NUM> could be a bi-stable spring that is straight in one orientation and curved in another. The wire <NUM> may be advanced until it is positioned between the cinch <NUM> and the needle <NUM>. Once positioned appropriately, the spring may be shifted to a second orientation, causing it to curve into a coil or spiral-like orientation.

Turning now to <FIG>, a method <NUM> according to embodiments of the present disclosure will be described in greater detail. At block <NUM>, the method may include passing a needle and a suture of a tissue suturing device through a target tissue, the tissue suturing device extending from a distal end of an endoscope. In some embodiments, the plurality of tissue supports are housed within a deployment device, wherein a first tissue support is exposed within a suture cavity. In some embodiments, the deployment device may be a cartridge or collar. In some embodiments, a cover may extend across the deployment device, the cover including an opening to permit access to the plurality of tissue supports by a needle. In some embodiments, the tissue supports may include one or more of the following: a flexible washer, an adhesive, a pledget, and an elastic or spring-loaded wire.

At block <NUM>, the method <NUM> may include deploying a first tissue support from the tissue suturing device to a position along a first portion of the target tissue. In some embodiments, the first tissue support may be engaged within the suture cavity by the needle to remove the first tissue support from the deployment device. At block <NUM>, the method <NUM> may include deploying a second tissue support from the tissue suturing device to a position along a second portion of the target tissue, wherein tightening the suture brings the first tissue support and the second tissue support closer together.

Although the illustrative method <NUM> is described above as a series of acts or events, the present disclosure is not limited by the illustrated ordering of such acts or events unless specifically stated. For example, some acts may occur in different orders and/or concurrently with other acts or events apart from those illustrated and/or described herein, in accordance with the disclosure. In addition, not all illustrated acts or events may be required to implement a methodology in accordance with the present disclosure. Furthermore, the method <NUM> may be implemented in association with the formation and/or processing of structures illustrated and described herein as well as in association with other structures not illustrated.

It will be further understood that the terms, "comprises" and/or "comprising," or "includes" and/or "including" when used herein, specify the presence of stated features, regions, steps elements and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and/or groups thereof.

Furthermore, the terms "substantial" or "substantially," as well as the terms "approximate" or "approximately," can be used interchangeably in some embodiments, and can be described using any relative measures acceptable by one of skill. For example, these terms can serve as a comparison to a reference parameter, to indicate a deviation that will still provide the intended function. Although non-limiting, the deviation from the reference parameter can be, for example, in an amount of less than <NUM>%, less than <NUM>%, less than <NUM>%, less than <NUM>%, less than <NUM>%, less than <NUM>%, and so on.

Claim 1:
A tissue suturing apparatus (<NUM>) for use with an endoscope (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>), comprising
- a tissue suturing device (<NUM>; <NUM>) coupleable to a distal end (<NUM>) of the endoscope (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>), the tissue suturing device (<NUM>; <NUM>) comprising:
a plurality of tissue supports (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>), wherein each of the plurality of tissue supports (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) is deployable towards a target tissue (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>), and wherein one or more tissue supports (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) of the plurality of tissue supports (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) is configured to receive a suture (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) during deployment, and
a needle (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>), wherein the needle (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) engages a tissue support (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) of the plurality of tissue supports (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) to deploy the tissue support (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>); and
- a deployment device (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>), wherein the plurality of tissue supports (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) is contained within the deployment device (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) prior to deployment, the deployment device (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) comprising:
a housing (<NUM>; <NUM>; <NUM>) containing the plurality of tissue supports (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>); and
a cover (<NUM>) extending across the housing (<NUM>; <NUM>; <NUM>), the cover (<NUM>) including an opening (<NUM>) to permit access to the plurality of tissue supports (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) by the needle (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) when attached to the suture (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>).