Patent Description:
A variety of endoscopic treatments may result in defects (or wounds) that are too large for hemostasis clips to easily bridge and thus help to close the defect. Examples of such endoscopic treatments include removal of large lesions, tunneling under the mucosal layer, full thickness removal of tissue, treating other organs by passing outside of the gastrointestinal tract, and repair of post-surgical issues such as post-surgical leaks, failing surgical staple lines and anastomotic leaks. Endoscopic treatments also include bariatric revision procedures. Of the known devices and methods for endoscopically closing large defects, each has certain advantages and disadvantages. <CIT> discloses a medical system including an endcap having first and second arms, a needle, a suture, and first and second control members, wherein the first and second control members are used to pass the needle back -and- forth between the first and second arms.

The invention is defined in claim <NUM> and is directed to a suture device including a mounting structure that is adapted to be secured relative to a distal end of an endoscope and a suture ring that is secured relative to the mounting structure and defines an arcuate channel extending within the suture ring. A first arcuate needle passer is slidingly disposed within a first side of the arcuate channel and includes a working end and a control end. A first control element is operably coupled to the control end of the first arcuate needle passer and an arcuate needle is releasably securable to the first needle passer.

The suture device further includes a second arcuate needle passer that is slidingly disposed within a second side of the arcuate channel and that includes a working end and a control end. A second control element is operably coupled to the control end of the second arcuate needle passer. The arcuate needle is passable between the first arcuate needle passer and the second arcuate needle passer and includes a first latching feature adapted to releasably secure the arcuate needle to the first arcuate needle passer and a second latching feature adapted to releasably secure the arcuate needle to the second arcuate needle passer. The first control element and the second control element cross over each other upon entering the arcuate channel of the suture ring.

Alternatively or additionally, the first latching feature may include a first pair of radially spaced protrusions disposed within a first portion of the arcuate needle and the second latching feature may include a second pair of radially spaced protrusions disposed within a second portion of the arcuate needle.

Alternatively or additionally, the arcuate needle may further include a suture aperture disposed between the first latching feature and the second latching feature.

Alternatively or additionally, the first needle passer may include a first aperture that is complementary to a first protrusion of the first pair of protrusions and a second aperture that is complementary to a second protrusion of the first pair of protrusions.

Alternatively or additionally, the first arcuate needle passer may include a first pair of longitudinally aligned slots extending from the working end and towards the control end of the first arcuate needle passer, each of the first pair of longitudinally aligned slots extending through one of the first aperture and the second aperture such that the first arcuate needle passer is able to flex relative to the first aperture and the second aperture when not constrained by the first side of the arcuate suture ring.

Alternatively or additionally, the second arcuate needle passer may include a first aperture that is complementary to a first protrusion of the second pair of protrusions and a second aperture that is complementary to a second protrusion of the second pair of protrusions.

Alternatively or additionally, the second arcuate needle passer may include a second pair of longitudinally aligned slots extending from the working end and towards the control end of the second arcuate needle passer, each of the second pair of longitudinally aligned slots extending through one of the first aperture and the second aperture such that the second arcuate needle passer is able to flex relative to the first aperture and the second aperture when not constrained by the second side of the arcuate suture ring.

Alternatively or additionally, the suture ring may extend in a circle from a first open end to a second open end, the first open end and the second open end spaced apart a distance that permits tissue to extend therebetween.

Alternatively or additionally, the annular channel may have a circular cross-sectional profile except for a first region proximate the first open end and a second region proximate the second open end.

Alternatively or additionally, the first region and the second region may each have an ovoid cross-sectional profile that allows the first arcuate needle passer and/or the second needle passer to begin to flex as the first arcuate needle passer exits the first open end and/or the second arcuate needle passer exits the second open end.

Alternatively or additionally, the first control element may enter the first side of the arcuate channel substantially parallel to a tangent of the first arcuate needle passer proximate where the first control element is secured to the first arcuate needle passer.

Alternatively or additionally, the second control element may enter the second side of the arcuate channel substantially parallel to a tangent of the second arcuate needle passer proximate where the second control element is secured to the second arcuate needle passer.

Alternatively or additionally, the suture device may further include a first tubular member housing the first control element and a second tubular member housing the second control element.

In another example, a suture device that is adapted to be used in combination with an endoscope includes a suture ring having a first side and a second side and defining an arcuate channel extending within the suture ring. A first tubular member includes a curved distal portion that curves in a direction opposed to a direction of curvature of the first side of the suture ring. A second tubular member includes a curved distal portion that curves in a direction opposed to a direction of curvature of the second side of the suture ring. A first arcuate needle passer is slidingly disposed within a first side of the arcuate channel and a second arcuate needle passer is slidingly disposed within a second side of the arcuate channel. A first control element is disposed within the first tubular member and is operably coupled to the first arcuate needle passer. A second control element is disposed within the second tubular member and is operably coupled to the second arcuate needle passer. An arcuate needle is passable between the first arcuate needle passer and the second arcuate needle passer by manipulating the first control element and the second control element.

Alternatively or additionally, the first needle passer may include a working end adapted to releasably secure the arcuate needle.

Alternatively or additionally, the first arcuate needle passer may include a first pair of longitudinally aligned slots extending through the working end of the first needle passer such that the working end of the first needle passer is able to flex when not constrained by the first side of the arcuate suture ring.

Alternatively or additionally, the second arcuate needle passer includes a working end adapted to releasably secure the arcuate needle.

Alternatively or additionally, the second arcuate needle passer may include a second pair of longitudinally aligned slots extending through the working end of the second arcuate needle passer such that the working end of the second arcuate needle passer is able to flex when not constrained by the second side of the arcuate suture ring.

In another example, a suture device that is adapted to be used in combination with an endoscope includes an end cap ring that is adapted to be secured to a distal end of an endoscope and a C-shaped suture ring that is secured to the end cap ring. The C-shaped suture ring has a first side and a second side, and defines an arcuate channel extending within the suture ring. A first arcuate needle passer is slidingly disposed within a first side of the arcuate channel and a second arcuate needle passer is slidingly disposed within a second side of the arcuate channel. A first control element is adapted to enter the first side of the arcuate channel substantially parallel to a tangent of the first needle passer proximate where the first control element is secured to the first needle passer and a second control element is adapted to enter the second side of the arcuate channel substantially parallel to a tangent of the second needle passer proximate where the second control element is secured to the second needle passer. An arcuate needle is passable between the first arcuate needle passer and the second arcuate needle passer by manipulating the first control element and the second control element.

The disclosure may be more completely understood in consideration of the following description of in connection with the accompanying drawings, in which:.

While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. The invention is defined by the appended claims only.

Definitions of certain terms are provided below and shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

Although some suitable dimensions, ranges and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art would understand desired dimensions, ranges and/or values may deviate from those expressly disclosed.

As used in this specification and the appended claims, the singular forms "a," "an," and "the" include or otherwise refer to singular as well as plural referents, unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed to include "and/or," unless the content clearly dictates otherwise.

The detailed description and the drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention which is defined by the claims only.

The disclosure pertains to devices that are configured to be used in combination with an endoscope or a similar delivery device for closing wounds within the body. In some instances, the suture devices described herein may be configured such that they may be used in combination with a single working channel endoscope or a dual working channel endoscope within a single working or available channel of an endoscope, and in some cases may be operated by a single individual, although in some cases a second individual may be involved.

<FIG> is a perspective view of an illustrative assembly <NUM> that includes an illustrative suture device <NUM> secured relative to an endoscope <NUM> while <FIG> is an end view of the illustrative assembly <NUM>. As shown, the illustrative suture device <NUM> includes an end cap ring <NUM> that is configured to secure the suture device <NUM> relative to the endoscope <NUM>. For example, the end cap ring <NUM> may be any over-the-scope connector. In some instances, the suture device <NUM> may instead include other structures or features (not illustrated) that are adapted to secure the suture device <NUM> relative to the endoscope <NUM>. The suture device <NUM> includes a C-shaped suture ring <NUM>. As will be shown with respect to subsequent drawings, the C-shaped suture ring <NUM> is adapted to permit arcuate-shaped needle passers to slide within the C-shaped suture ring <NUM> in order to pass an arcuate needle (not shown in <FIG>) to pass back and forth between a pair of arcuate-shaped needle passers.

The C-shaped suture ring <NUM> may be considered as tracing out a circle, apart from a missing part of the circle as shown between a first open end <NUM> and a second open end <NUM>. The missing part of the circle may be considered as defining a region <NUM> that can accommodate tissue therein to be sutured. In some instances, the relative dimensions of the C-shaped suture ring <NUM>, including the relative distance between the first open end <NUM> and the second open end <NUM> may be varied in order to accommodate different tissues, different relative needle passer sizes, and the like. Additionally, as shown the C-shaped suture ring <NUM> may be considered as forming a particular arcuate angle relative to the end cap ring <NUM>. This is merely illustrative, as the C-shaped suture ring <NUM> may be disposed at any desired angle relative to the end cap ring <NUM>. The C-shaped suture ring <NUM> may be attached at any desired position relative to the end cap <NUM>. In some cases, the relative position of the C-shaped suture ring <NUM> may be adjusted after delivery. In some cases, as best seen in <FIG>, the suture device <NUM> may be secured relative to the endoscope <NUM> such that the region <NUM> is centered or at least substantially centered relative to a main working channel <NUM> of the endoscope <NUM>, although this is not required in all cases. While additional tools are not necessary for usage of the suture device <NUM>, in some cases there may be a desire to provide tools through the working channel <NUM> that can reach the region <NUM>. For example, there may be a desire to use a grasper to help pull tissue towards the region <NUM>, or to hold tissue relative to the region <NUM>, while suturing. The region <NUM> may, therefore, also be considered as a working space for the suture device <NUM>.

The C-shaped suture ring <NUM> may be considered as including a first side <NUM> and a second side <NUM>. The suture device <NUM> includes a first tubular member <NUM> and a second tubular member <NUM>. The first side <NUM> of the C-shaped suture ring <NUM> is to the right (in the illustrated orientation) and the second side <NUM> of the C-shaped suture ring is to the left while the first tubular member <NUM> is to the left and the second tubular member <NUM> is to the right (e.g. see <FIG>, in which first and second control elements are visible. The first tubular member <NUM> may be seen as including a curved portion <NUM> and a linear portion <NUM> that extends proximally. Similarly, the second tubular member <NUM> may be seen as including a curved portion <NUM> and a linear portion <NUM> that extends proximally. It will be appreciated that the curved portion <NUM> of the first tubular member <NUM> is curved in a direction that is opposite a direction in which the first side <NUM> of the C-shaped suture ring <NUM> curves, and that the curved portion <NUM> of the second tubular member <NUM> is curved in a direction that is opposite a direction in which the second side <NUM> of the C-shaped suture ring <NUM> curves. In some cases, the relative curvature of the sides of the C-shaped suture ring <NUM> and the first and second tubular member <NUM>, <NUM> help to align the control elements with the arcuate needle passers (not shown in <FIG> and <FIG>).

<FIG> are partial cutaway views of the suture device <NUM> in which a portion of the suture ring <NUM>, the curved portion <NUM> of the first tubular member <NUM> and the curved portion <NUM> of the second tubular member <NUM> are cutaway to reveal further details of the suture device <NUM>. The suture device <NUM> includes a first arcuate needle passer <NUM> that is operably coupled with a first control element <NUM> and a second arcuate needle passer <NUM> that is operably coupled with a second control element <NUM>. It will be appreciated that the control elements <NUM>, <NUM> cross over each other at a location <NUM> proximate to where the first control element <NUM> is secured to the first arcuate needle passer <NUM> and the second control element <NUM> is secured to the second arcuate needle passer <NUM>. In some cases, allowing the first control element <NUM> and the second control element <NUM> to cross over each other can result in reduced effort needed to move the first control element <NUM> and the second control element <NUM> as a result of the control elements <NUM>, <NUM> being better aligned with their corresponding arcuate needle passers <NUM>, <NUM>. While the second control element <NUM> is shown as passing over the first control element <NUM>, this is just an example. An arcuate needle <NUM> may be seen as being passed between the first arcuate needle passer <NUM> and the second arcuate needle passer <NUM>.

In some cases, the first control element <NUM> enters the first side <NUM> of the arcuate channel <NUM> of the C-shaped suture ring <NUM> in a direction that is substantially parallel to a tangent of the first arcuate needle passer <NUM> proximate to where the first control element <NUM> is secured to the first arcuate needle passer <NUM>. In some cases, the second control element <NUM> enters the second side <NUM> of the arcuate channel <NUM> of the C-shaped suture ring <NUM> in a direction that is substantially parallel to a tangent of the second arcuate needle passer <NUM> proximate to where the second control element <NUM> is secured to the second arcuate needle passer <NUM>.

The C-shaped suture ring <NUM> defines an arcuate channel <NUM> that extends through the C-shaped suture ring <NUM> from the first open end <NUM> to the second open end <NUM>. As will be discussed in greater detail with respect to <FIG> and <FIG>, the arcuate channel <NUM> has a constant inner diameter and inner cross-sectional profile that is about the same as an outer diameter and outer cross-sectional profile of each of the first arcuate needle passer <NUM> and the second arcuate needle passer <NUM> with the exception of a first region <NUM> that is proximate the first open end <NUM> and a second region <NUM> that is proximate the second open end <NUM>. In some cases, as illustrated, the first region <NUM> includes a slot <NUM> that accommodates a suture secured to the arcuate needle <NUM> when the arcuate needle <NUM> is positioned therein and the second region <NUM> includes a slot <NUM> that accommodates a suture secured to the arcuate needle <NUM> when the arcuate needle <NUM> is positioned therein.

While no proximal handle or other mechanism is shown, it will be appreciated that a user can selectively advance the first arcuate needle passer <NUM> by actuating the first control element <NUM> in a first direction and can selectively retract the first arcuate needle passer <NUM> by actuating the first control element <NUM> in a second, opposing direction. A user can selectively advance the second arcuate needle passer <NUM> by actuating the second control element <NUM> in a first direction and can selectively retract the second arcuate needle passer <NUM> by actuating the second control element <NUM> in a second, opposing direction. A user may also hold either the first arcuate needle passer <NUM> or the second arcuate needle passer <NUM> in a particular position by simply holding the appropriate control element <NUM>, <NUM> from moving.

Starting with <FIG>, the first arcuate needle passer <NUM> can be seen as being retracted into the first side <NUM> of the C-shaped suture ring <NUM> and the second arcuate needle passer <NUM> can be seen as being retracted into the second side <NUM> of the C-shaped suture ring <NUM>. The arcuate needle <NUM> can be seen as being secured to the first arcuate needle passer <NUM>. Additional details as to how the arcuate needle <NUM> is secured to the first arcuate needle passer <NUM> will be discussed subsequently with respect to <FIG> and <FIG>. Moving to <FIG>, it can be seen that the first arcuate needle passer <NUM> has been advanced partially out of the first side <NUM> of the C-shaped suture ring <NUM> and into the region <NUM> by advancing the first control element <NUM> in an appropriate direction. Continuing on to <FIG>, the first arcuate needle passer <NUM> has been advanced further such that the arcuate needle <NUM> has contacted the second arcuate needle passer <NUM>. In some cases, the second arcuate needle passer <NUM> may be held in place by holding the second control element <NUM> in position while the first arcuate needle passer <NUM> is advanced further to drive the arcuate needle <NUM> into the second arcuate needle passer <NUM>. Finally, in <FIG>, the arcuate needle <NUM> may be seen as being secured to the second arcuate needle <NUM>, as the first arcuate needle passer <NUM> has been withdrawn by moving the first control element <NUM> in an appropriate direction.

It will be appreciated that the steps shown in <FIG> will result in having placed a stitch through tissue present within the region or working area <NUM>. By moving the suture device <NUM> (secured to the distal end of the endoscope <NUM>) laterally, a subsequent stitch may be placed by reversing the steps shown in <FIG>. As noted, in some cases, a grasper or other tool may be provided through the working channel <NUM> of the endoscope <NUM>, although this is not required for operation of the suture device <NUM>.

<FIG> is a perspective view of an arcuate needle passer <NUM> that may, for example, be used as either the first arcuate needle passer <NUM> or the second arcuate needle passer <NUM>. The arcuate needle passer <NUM> has a curvature that matches the curvature of the C-shaped suture ring <NUM> such that the arcuate needle passer <NUM> may easily slide relative to the arcuate channel <NUM> within the C-shaped suture ring <NUM>. While the arcuate needle passer <NUM> is shown as having a circular cross-sectional shape, this is not required in all cases. For example, the arcuate needle passer <NUM> could have a non-circular cross-sectional shape such as square or rectangular. The arcuate needle passer <NUM> may be considered as having a working end <NUM> and a control end <NUM>. The working end <NUM> is adapted to releasably secure the arcuate needle <NUM> while the control end <NUM> is adapted to be secured to a control element such as the first control element <NUM> or the second control element <NUM>. The arcuate needle passer <NUM> has a body <NUM> that extends from the working end <NUM> to the control end <NUM>. In some cases, the body <NUM> is formed from a hypotube, and thus is hollow.

The working end <NUM> includes a pair of apertures <NUM> that are radially spaced about <NUM> degrees apart. As will be discussed, the apertures <NUM> may be adapted to releasably secure corresponding and complementary latching features present on the arcuate needle <NUM>. The arcuate needle passer <NUM> includes a pair of slots <NUM> that may also be radially spaced about <NUM> degrees apart such that each of the slots <NUM> passes through one of the apertures <NUM>. When the arcuate needle passer <NUM> is positioned within the arcuate channel <NUM> of the C-shaped suture ring <NUM>, it will be appreciated that the relative dimensions therebetween limit movement and thus secure the arcuate needle <NUM> relative to the arcuate needle passer <NUM>. When the working end <NUM> extends outwardly from the arcuate channel <NUM> of the C-shaped suture ring <NUM>, the slots <NUM> are adapted to allow the working end <NUM> to fully flex relative to the apertures <NUM>, which can allow the arcuate needle passer <NUM> to release the arcuate needle <NUM>.

<FIG> is a perspective view showing a portion <NUM> of the C-shaped suture ring <NUM>, the arcuate needle passer <NUM> and the arcuate needle <NUM>. The portion <NUM> of the C-shaped suture ring <NUM> includes a region <NUM> that corresponds to the first region <NUM> and/or the second region <NUM>, having a non-circular cross-sectional profile as seen in <FIG>, which is a cross-section taken along line <NUM>-<NUM> of <FIG>. One of the slots <NUM> may be seen as extending through one of the apertures <NUM>, although the other slot <NUM> and the other aperture <NUM> are on the opposing side and thus are not visible in this view. The arcuate needle <NUM> includes a protrusion <NUM> that engages the visible aperture <NUM>. It will be appreciated that there is a second protrusion <NUM> that is radially spaced about <NUM> degrees apart and thus may be engaged in the other aperture <NUM>. As seen in <FIG>, the inner profile of the region <NUM> is larger than an outer profile of the arcuate needle passer <NUM>, which permits sufficient flexing of the working end <NUM> of the arcuate needle passer <NUM> when the working end <NUM> is disposed within the region <NUM> to allow the arcuate needle <NUM> to be pushed into registration with the working end <NUM> to permit the arcuate needle <NUM> to be transferred from one arcuate needle passer to the other. In the position shown in <FIG>, the arcuate needle passer <NUM> is positioned to transfer the arcuate needle <NUM> to another arcuate needle passer.

It will be appreciated that the arcuate needle <NUM> is always held by at least one of the first arcuate needle passer <NUM> and the second arcuate needle passer <NUM>. When the working end <NUM> of the arcuate needle passer <NUM> (representative of either the first arcuate needle passer <NUM> or the second arcuate needle passer <NUM>) is disposed within the region <NUM> (shown in <FIG>), there is enough flex within the arcuate needle passer <NUM> to allow the arcuate needle <NUM> to be transferred from the other arcuate needle passer. When the working end <NUM> of the arcuate needle passer <NUM> passes out beyond the region <NUM>, there is enough flex possible relative to the apertures <NUM> and the slots <NUM> to permit the arcuate needle passer <NUM> to transfer the arcuate needle <NUM> to the other arcuate needle passer. Accordingly, the arcuate needle <NUM> cannot be dropped as the arcuate needle <NUM> will always be secured relative to one of the arcuate needle passers <NUM>, <NUM>.

<FIG> is a perspective view of the arcuate needle <NUM>. The arcuate needle <NUM> includes a curved body <NUM> that has a curvature that matches the curvature of the first arcuate needle passer <NUM> and the second arcuate needle passer <NUM> such that the first and second arcuate needle passers <NUM>, <NUM> may move freely within the arcuate channel <NUM>, in response to relative movement of the control elements <NUM>, <NUM>, with the arcuate needle <NUM> secured to either of the first and second arcuate needle passers <NUM>, <NUM>. The curved body <NUM> has a pair of protrusions <NUM> that may be considered as being latching features that can releasably engage corresponding apertures <NUM> in one of the first and second arcuate needle passers <NUM>, <NUM>. The curved body <NUM> has a pair of protrusions <NUM> that may be considered as being latching features that can releasably engage corresponding apertures <NUM> in the other of the first and second arcuate needle passers <NUM>, <NUM>. While the protrusions <NUM>, <NUM> are shown as being circular in cross-section, other shapes are contemplated as well. The apertures <NUM> may vary, depending on the profile of the protrusions <NUM>,<NUM>. A suture aperture <NUM> extends through the curved body <NUM> to accommodate a suture. The curved body <NUM> has sharpened ends <NUM>, <NUM> such that the arcuate needle <NUM> can pass through tissue in either direction.

It will be appreciated that a variety of different materials may be used in forming the devices described herein. In some cases, a variety of different metals may be used. Illustrative but non-limiting examples of suitable metals include titanium, stainless steel, magnesium, cobalt chromium and others. In some cases, the first control element <NUM> and the second control element may be made of Nitinol. In some embodiments, for example, the devices described herein may include any suitable polymeric material, including biocompatible materials such as polyurethane or silicone. Suitable polymers include PEEK (polyetheretherketone) and Polycarbonate. Other suitable polymers include but are not limited to polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like.

Claim 1:
A suture device (<NUM>) comprising:
a mounting structure (<NUM>) adapted to be secured relative to a distal end of an endoscope (<NUM>);
a suture ring (<NUM>) secured relative to the mounting structure, the suture ring (<NUM>) defining an arcuate channel (<NUM>) extending within the suture ring (<NUM>);
a first arcuate needle passer (<NUM>, <NUM>) slidingly disposed within a first side (<NUM>) of the arcuate channel (<NUM>), the first arcuate needle passer (<NUM>, <NUM>) including a working end (<NUM>) and a control end (<NUM>);
a first control element (<NUM>) operably coupled to the control end (<NUM>) of the first arcuate needle passer (<NUM>, <NUM>);
an arcuate needle (<NUM>) releasably securable to the first arcuate needle passer (<NUM>, <NUM>),
a second arcuate needle passer (<NUM>, <NUM>) slidingly disposed within a second side (<NUM>) of the arcuate channel (<NUM>), the second arcuate needle passer (<NUM>, <NUM>) including a working end (<NUM>) and a control end (<NUM>);
a second control element (<NUM>) operably coupled to the control end (<NUM>) of the second arcuate needle passer (<NUM>, <NUM>);
wherein the arcuate needle (<NUM>) is passable between the first arcuate needle passer (<NUM>, <NUM>) and the second arcuate needle passer (<NUM>, <NUM>) and includes a first latching feature (<NUM>, <NUM>) adapted to releasably secure the arcuate needle to the first arcuate needle passer (<NUM>) and a second latching feature (<NUM>, <NUM>) adapted to releasably secure the arcuate needle to the second arcuate needle passer (<NUM>);
characterized in that the first control element (<NUM>) and the second control element (<NUM>) cross over each other upon entering the arcuate channel (<NUM>) of the suture ring (<NUM>).