Patent Description:
A variety of endoscopic treatments may result in defects (or wounds) that are too large for known closure methods. 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 post-surgical repair of post-surgical 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> relates to an endoscopic suturing device that can be employed to suture tissue using endoscopic techniques to place one or more stitches in tissue during a single intubation of an endoscope. The suturing device may include a suturing capsule with a suction chamber that is configured to capture tissue that is to be sutured. A needle is movable along a pathway across the suction chamber to penetrate and place stitches in the captured tissue. A catch is located distal to the suction chamber to receive and retain the suture during a stitching sequence. The catch may be movable along the needle pathway and configured to release the suture when the catch moves a predetermined distance along the pathway. The catch may be configured so that a predetermined amount of force is required to move the catch the predetermined distance required to release the suture.

<CIT> relates to an endoscopic suturing system for joining internal body tissues in a variety of procedures. The system comprises a suturing capsule releasably mountable to the distal end of an endoscope and capable of forming multiple stitches in tissue at a plurality of locations without requiring withdrawal of the capsule from the patient between stitches. Also enclosed is a suture lock to secure the placed stitch that is delivered by a device introduced through the working channel of the indwelling endoscope. Suitable control handles for the suturing capsule and for the suture lock delivery device positioned at the proximal end of the endoscope are provided to facilitate operation by the user.

<CIT> relates to a combination tissue apposition and suture capturing device for performing endoscopic procedures typically in the gastro-esophageal tract. The device is particularly adapted for forming multiple plications used in a gastroplasty procedure devised to cure or ameliorate gastro-esophageal reflux disease. The device includes a tissue sewing capsule attached to the distal end of an endoscope having a needle that is deposited in a capsule distal tip cavity following the suturing of a tissue fold and retrieved to enable the suturing of a subsequent tissue fold without the need for multiple intubations. A suture clip delivery device is also disclosed that is adapted to fit within the capsule to enable suture capture without the need for multiple intubations. The combination device eliminates the need for an overtube and maximizes the speed efficiency of the gastroplasty procedure. A method for using the combination device is also disclosed. Document <CIT> discloses an endoscopic tissue suturing device, comprising: a suturing capsule that is mountable to a distal end of an endoscope, the suturing capsule adapted to capture tissue at a tissue capture region thereof; a needle that is slidable in a longitudinal direction within the suturing capsule along a pathway that extends from a proximal end of the tissue capture region to a distal end of the tissue capture region, the needle is adapted to penetrate tissue captured within the tissue capture region when the needle is extended in a distal direction from the proximal end to the distal end of the tissue capture region; a suture tag that is securable to the needle to carry a suture across the tissue capture region; and a suture tag catch positioned distal to the tissue capture region to retain the suture tag at a distal end of the tissue capture region when the suture tag is released from the needle and the needle is retracted to the proximal end of the tissue capture region, the suture tag catch being movable in the longitudinal direction to release the suture tag when the suture tag is locked to the needle and the needle is retracted toward the proximal end of the tissue capture region.

The disclosure is directed to several alternative designs, materials and methods of devices for endoscopically closing large defects. An example is a suture assembly for use in combination with an endoscope having a working channel and a distal end. The suture assembly includes a translation assembly that is axially translatable within the working channel and that includes a needle configured to carry a suture, a distal shuttle configured to releasably secure the needle and a sleeve that is disposable over the distal shuttle. The sleeve is movable between a locked position in which the needle is secured to the distal shuttle and an unlocked position in which the needle is releasable from the distal shuttle. A distal endcap is securable to the distal end of the endoscope and is configured to engage the needle when the needle is advanced distally into the endcap and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is withdrawn proximally. An attachment mechanism is disposable over an exterior of the endoscope proximate the distal end thereof and is configured to releasably secure the distal endcap relative to the distal end of the endoscope.

Alternatively or additionally, the attachment mechanism may include an inner collet member that is configured to engage the distal endcap and form a compressive fit with the endoscope and an outer collet member that is configured to engage the inner collet member in order to form the compressive fit between the inner collet member and the endoscope.

Alternatively or additionally, the distal endcap may further include an annular flange disposed at a proximal end of the distal endcap, and the inner collet member may further include a corresponding annular slot disposed near a distal end of the inner collet member, the annular slot configured to engage the annular flange, thereby providing an interference fit between the distal endcap and the inner collet member.

Alternatively or additionally, the inner collet member may include an body having a plurality of fingers extending axially in a proximal direction from the distal end of the inner collet member, the plurality of fingers defining an inner surface that is configured to engage the endoscope and an outer surface that provides threads to threadedly engage the outer collet adaptor.

Alternatively or additionally, the outer collet member may be configured to urge the plurality of fingers inwardly as the outer collet member is advanced over the inner collet member.

Alternatively or additionally, the attachment mechanism may include a split ring attachment mechanism disposable over an exterior of the endoscope proximate the distal end thereof, the split ring attachment mechanism including an endoscope engaging portion adapted to engage the endoscope in a compressive fit and a distal endcap engaging portion adapted to engage the distal endcap in an interference fit.

Alternatively or additionally, the split ring attachment mechanism may include an elongate body having an inner surface that is adapted to fit over an exterior surface of the endoscope and a living hinge extending longitudinally along the elongate body. The elongate body includes a first body portion extending circumferentially in a first direction from the living hinge and a second body portion extending circumferentially in a second direction from the living hinge.

Alternatively or additionally, once the elongate body has been advanced radially over the endoscope and the distal end cap, the elongate body may be configured to be held in a locking configuration in which the distal endcap is secured to the distal end of the endoscope via one or more members that extend at least partially radially around the elongate body.

Alternatively or additionally, the distal endcap may further include an annular flange disposed at a proximal end of the distal endcap, and the split ring attachment mechanism may further include a corresponding annular slot configured to engage the annular flange, thereby providing an interference fit between the distal endcap and the split ring attachment mechanism.

Alternatively or additionally, the inner collet member may be integrally formed with the distal endcap.

Alternatively or additionally, the inner collet member may include a plurality of fingers extending proximally from the distal endcap, and the outer collet member may include a ring that is configured to be moved proximally over the plurality of fingers, thereby pressing the plurality of fingers into a compressive fit with the endoscope.

Alternatively or additionally, the attachment mechanism may include a fixation member extending from the distal endcap and an elastomeric sleeve configured to form a compressive fit with the endoscope, the elastomer sleeve including a fixation aperture that is complementary to the fixation member.

Another example is a suture assembly for use in combination with an endoscope having a working channel and a distal end. The suture assembly includes a translation assembly that is axially translatable within the working channel and is adapted to releasably engage and disengage a needle. A distal endcap is securable to the distal end of the endoscope and is adapted to releasable engage the needle when the translation assembly disengages the needle and to disengage the needle when the translation assembly engages the needle, the distal endcap including a fixation flange disposed near a proximal end of the distal endcap. An inner collet member is configured to engage the distal endcap and form a compressive fit with the endoscope and an outer collet member is configured to engage the inner collet member in order to form the compressive fit between the inner collet member and the endoscope.

Alternatively or additionally, the outer collet member may be threadedly engageable with the inner collet member in order to form the compressive fit with the endoscope.

Another example is a suture assembly for use in combination with an endoscope having a working channel and a distal end. The suture assembly includes a translation assembly that is axially translatable within the working channel and is adapted to releasably engage and disengage a needle. A distal endcap is securable to the distal end of the endoscope and is adapted to releasable engage the needle when the translation assembly disengages the needle and to disengage the needle when the translation assembly engages the needle, the distal endcap including a fixation flange disposed near a proximal end of the distal endcap. A split ring device is disposable over an exterior of the endoscope proximate the distal end thereof, the split ring device including a cylindrical inner surface adapted to frictionally engage an outer surface of the endoscope and an annular slot adapted to engage the fixation flange in an interference fit.

Alternatively or additionally, the split ring device may include an inner surface that is adapted to fit over an exterior surface of the endoscope.

Alternatively or additionally, the split ring device may include a living hinge that divides the split ring device into a first clamping portion extending circumferentially in a first direction from the living hinge and a second clamping portion extending circumferentially in a second direction from the living hinge.

Alternatively or additionally, the split ring device may be movable between a locking configuration in which the first clamping portion and the second clamping portion frictionally engage an outer surface of the endoscope and an engagement configuration in which the first clamping portion and the second clamping portion are deflected away from the locking configuration.

Alternatively or additionally, the split ring device may further include a first hook extending from the first clamping portion and a second hook extending from the second body clamping portion.

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

On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure.

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, incited by the present disclosure, 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 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 within a single working or available channel of an endoscope, and in some embodiments may be operated by a single individual, although in some embodiments a second individual may be involved. In some embodiments, the suture devices described herein may be considered as operating along a single line of operation. The device itself may be translatable distally and proximally within a working channel, and a handle portion may itself be translatable distally and proximally along the same line of operation in locking and unlocking a needle to be able to pass the needle back and forth between an active portion of the suture device and a passive portion of the suture device. The device may be configured to enable the needle to be selectively locked into either of a more distal position or a more proximal position, and the device may itself be translated distally or proximally with the needle locked in place in order to move the needle, and hence a suture, relative to the tissue being repaired.

<FIG> is a perspective view of a suture device <NUM> that may be considered as being configured for use in combination with a delivery system including a lumen that extends through the delivery system. For example, the delivery system may be an endoscope having a working channel. The delivery system may also be a catheter. It will be appreciated that there is a change in scale on either side of the break line shown. In some embodiments, the suture device <NUM> may be considered as including a suture translation assembly <NUM> that is configured to be axially translatable within the lumen of the delivery system and a distal assembly <NUM> that is configured to be secured to a distal end of the delivery system. The suture translation assembly <NUM> extends into the distal assembly <NUM> and includes a needle <NUM> that may be used to carry a suture as well as a distal shuttle <NUM> that is configured to releasably secure the needle <NUM>.

A member <NUM> may be disposed over the distal shuttle <NUM> and, as will be shown in subsequent Figures, is movable between a locked position in which the needle <NUM> is secured to the distal shuttle <NUM> and an unlocked position in which the needle <NUM> is releasable from the distal shuttle <NUM>. In some embodiments, for example, the member <NUM> may be a sleeve <NUM>. A user interface may extend proximally from the distal shuttle <NUM> and the sleeve <NUM>, and may be configured to move the sleeve <NUM> between the locked position and the unlocked position. A shaft <NUM> may extend distally to the suture translation assembly <NUM>, and may in particular be coupled to the sleeve <NUM>. The user interface may take a number of different forms. For examples, the user interface may be the user interface <NUM> as described and illustrated in <CIT>.

In some embodiments, the user interface may be as described in a provisional application Serial No. <CIT> and entitled ENDOSCOPIC SUTURING CONTROL HANDLE. In some instances, the user interface may be as described in a provisional application filed on the even date herewith, Attorney Docket No.<CIT> entitled CONTROL HANDLE FOR ENDOSCOPIC SUTURING. These are just examples.

In some embodiments, the distal assembly <NUM> includes a body <NUM> having a proximal connector <NUM> that may be configured to be coupled to the distal end of an endoscope or other delivery system. In some embodiments, as illustrated, the proximal connector <NUM> may include a fixation feature <NUM>. As will be discussed with respect to subsequent Figures, the fixation feature <NUM>, which may in some embodiments be considered as being a fixation flange <NUM>, helps to secure the distal assembly <NUM> to the distal end of an endoscope or other delivery system using a split ring attachment mechanism.

The body <NUM> includes an arm <NUM> that extends to an endcap <NUM>. As will be discussed, the endcap <NUM> may be configured to releasably engage and disengage the needle <NUM>. In some embodiments, for example, the endcap <NUM> may be configured to engage the needle <NUM> when the needle <NUM> is advanced distally into the endcap <NUM>, and to release the needle <NUM> when the needle <NUM> is locked into the distal shuttle <NUM> (as will be discussed) and the distal shuttle <NUM> is withdrawn proximally. The distal assembly <NUM> may be considered as including a guide member <NUM> that may be secured to or integrally formed with the body <NUM>, and may permit the suture translation assembly <NUM> to extend through the guide member <NUM> and to translate relative to the guide member <NUM>. In some embodiments, the body <NUM> may include an aperture <NUM> that may enable other devices to be inserted through the aperture <NUM>. In some instances, as will be discussed with respect to subsequent Figures, the aperture <NUM> may be configured to accommodate a side-saddled lumen attachment element. In some embodiments, the aperture <NUM> may include one or more of a pin aperture 31a and a pin aperture 31b that may, for example, be used to mount the aforementioned side-saddled lumen attachment element, or possibly other features as well.

<FIG> and <FIG> show the suture translation assembly <NUM> extended through the guide member <NUM> and into the distal assembly <NUM>. In <FIG>, the suture translation assembly <NUM> is shown in an extended position in which the needle <NUM> extends into the endcap <NUM> while in <FIG>, the suture translation assembly <NUM> is shown in a retracted position in which the needle <NUM> has been withdrawn proximally from the endcap <NUM>. In some embodiments, as can be seen, the endcap <NUM> includes a proximal needle opening <NUM> that is configured to help guide the needle <NUM> into the proximal needle opening <NUM> as well as to accommodate the needle <NUM> when the needle <NUM> is advanced distally into the endcap <NUM>. In some embodiments, the proximal needle opening <NUM> may extend all the way through the endcap <NUM> while in other cases the proximal needle opening <NUM> may not pass all the way through the endcap <NUM>. In some instances, as shown, the proximal needle opening <NUM> may be considered as being aligned with a longitudinal axis <NUM> of the needle <NUM> (as shown in <FIG>).

One or more securement openings <NUM> may be arranged orthogonal to the proximal needle opening <NUM> and one or more securements <NUM> that are configured to be disposed within the one or more securement openings <NUM>, and which are configured to releasably engage the distal detent (as will be discussed) of the needle <NUM>. In some embodiments, there may be a pair of securement openings <NUM>, one on either side of the endcap <NUM>. In some embodiments, there may be a pair of securements <NUM>, with one disposed within each of the pair of securement openings <NUM>. In some embodiments, while shown schematically, the one or more securements <NUM> may be springs or coils, for example.

<FIG> is a cross-sectional view of the distal assembly <NUM>, with the suture translation assembly <NUM> disposed within the distal assembly <NUM>. <FIG> is an exploded view of the suture translation assembly <NUM>. The needle <NUM> may be considered as including a distal region <NUM> and a proximal region <NUM>. In some embodiments, the distal region <NUM> may include a distal detent <NUM> for releasably engaging the endcap <NUM> and the proximal region <NUM> may include a proximal detent <NUM> for releasably engaging the distal shuttle <NUM>. The needle <NUM> may, as shown, include an aperture <NUM> for accommodating a suture line passing therethrough.

In some embodiments, the distal shuttle <NUM> may be considered as including a distal needle opening <NUM> that is configured to accommodate the needle <NUM> when the distal shuttle <NUM> is advanced distally over the needle <NUM> and that is aligned with the longitudinal axis <NUM> of the needle <NUM>. One or more bearing ball openings <NUM> may be arranged orthogonal to the distal needle opening <NUM> such that the one or more bearing ball openings <NUM> align with the proximal detent <NUM> when the needle <NUM> is secured to the distal shuttle <NUM>. In some embodiments, one or more bearing balls <NUM> may be disposed within the one or more bearing ball openings <NUM> and may be configured to be disposed within the proximal detent <NUM> when the needle is secured to the distal shuttle <NUM>.

In some embodiments, the distal shuttle <NUM> includes an internal void <NUM> and a sleeve capture member <NUM> that is slidingly disposed within the internal void <NUM>. In some embodiments, the sleeve capture member <NUM> may be coupled to a cable <NUM> extending distally within the shaft <NUM> and into a cable aperture <NUM> and secured via a crimp or other mechanical connection <NUM>. In some embodiments, the sleeve capture member <NUM> may be coupled to the sleeve <NUM> via a pin <NUM> that extends through first and second sleeve connection apertures <NUM>, <NUM> and a corresponding aperture <NUM> extending through the sleeve capture member <NUM> as well as extending through the internal void <NUM>.

In some embodiments, the sleeve <NUM> includes one or more sleeve openings <NUM> that may be smaller in diameter, or smaller in width, than the diameter of the one or more bearing balls <NUM>. In some embodiments, the sleeve <NUM> may include a pair of sleeve openings <NUM>, corresponding to a pair of bearing ball openings <NUM> and a pair of bearing balls <NUM>. When the sleeve <NUM> is in the locked position, as shown for example in <FIG>, the one or more sleeve openings <NUM> are misaligned with, or do not align with, the one or more bearing ball openings <NUM>, and so the one or more bearing balls <NUM> engage the proximal detent <NUM> of the needle <NUM>. The sleeve <NUM> prevents the one or more bearing balls <NUM> from being pushed out of the proximal detent <NUM>.

Conversely, when the sleeve <NUM> is in the unlocked position, as shown for example in <FIG>, the one or more sleeve openings <NUM> are aligned with the one or more bearing ball openings <NUM>. This permits the one or more bearing balls <NUM> to move radially out, into the one or more sleeve openings <NUM>, a distance sufficient to permit the one or more bearing balls <NUM> to clear the proximal detent <NUM> of the needle <NUM> in response to a force applied to the one or more bearing balls <NUM> by the needle <NUM>. With reference to <FIG>, while the suture translation assembly <NUM> is shown advanced into the distal assembly <NUM>, the sleeve <NUM> is in the unlocked position relative to the distal shuttle <NUM>, and thus the one or more bearing balls <NUM> may be seen as extending partially into the one or more sleeve openings <NUM>.

In some embodiments, it will be appreciated that the distal shuttle <NUM>, and the sleeve <NUM>, in combination, provide an active connection to the needle <NUM> while the distal endcap <NUM> provides a passive connection to the needle <NUM>. If the needle <NUM> is moved distally into the distal endcap <NUM>, the distal endcap <NUM> will grab onto the needle <NUM>, with the one or more securements <NUM> engaging the distal detent <NUM>. If the needle <NUM> is subsequently moved proximally, the axial force applied overcomes any resistance provided by the one or more securements <NUM>, and the needle <NUM> is able to release from the distal endcap <NUM> and move proximally. In contrast, the active connection to the needle <NUM> provided by the distal shuttle <NUM> and the sleeve <NUM>, however, requires action to move the sleeve <NUM>, relative to the distal shuttle <NUM>, between the locked position and the unlocked position. The user interface provides a mechanism for positively moving the sleeve <NUM> between the locked and unlocked positions.

<FIG> is a side view of a distal assembly 14a that may, for example, be usable in the suture device <NUM> shown in <FIG>. The distal assembly 14a is similar to the distal assembly <NUM> shown in previous Figures, but includes a side-saddled lumen attachment element <NUM> that is coupled to the body <NUM> of the distal assembly 14a. In some embodiments, the side-saddled lumen attachment element <NUM> may include one or two pegs <NUM> that fit into the pin apertures 31a and 31b (pin aperture 31a is visible in this view) and thus enable the side-saddled lumen attachment element <NUM> to pivot relative to the body <NUM> of the distal assembly 14a. In some embodiments, the side-saddled lumen attachment element <NUM> includes a ring <NUM>, from which the pegs <NUM> extend, a distal region <NUM> and a body <NUM> that in some instances has a curvature to it.

In some embodiments, the distal region <NUM> and the body <NUM> have a semicircular profile in order to accommodate a lumen such as a flexible lumen <NUM> that may engage within the side-saddled lumen attachment element <NUM> via a frictional or compressive fit as shown in <FIG>. The flexible lumen <NUM> may be polymeric or metallic. A polymeric lumen may, for example, be expanded to a full working dimension by extending a mandrel through the flexible lumen <NUM> after the flexible lumen <NUM> has been placed relative to the side-saddled lumen attachment element <NUM>.

In some embodiments, the side-saddled attachment element <NUM> (and accompanying flexible lumen <NUM>) may be used as a secondary working channel and may contain the suture used in the procedure. In some embodiments, it may be large enough to accommodate secondary tools for use during the procedure for tissue acquisition or manipulation allowing secondary tool use without requiring a dedicated dual-channel delivery system such as a dual channel endoscope. If desired, a dual-channel delivery system could be used to provide even more options in a procedure. The side-saddled attachment element <NUM> may have an exit port in the distal assembly 14a such that secondary tools extend along an axis suitable for tissue manipulation. This axis may cross the axis of the suture carrying element, allowing a secondary tool to pull tissue into the suture carrying element's projected path. For example, this could be used to pull tissue in line with a needle to assist in driving the needle <NUM> through the tissue. Maintaining tension on the suture through the side-saddled attachment element <NUM> may keep the suture from interfering with the procedure.

<FIG> is a perspective view of a distal assembly 14b that includes a shorter side-saddled lumen attachment element 120a that may be pivotally secured to the body <NUM> via one or more pegs 122a that extend into the pin apertures 31a, 31b. A lumen 130a coupled with the side-saddled lumen attachment element 120a to provide a working channel through which the suture or other tools may be extended.

<FIG> are views of a tissue release mechanism <NUM> that may fit over the arm <NUM>. In some embodiments, the tissue release mechanism <NUM> may assist in a procedure by helping to remove tissue that may otherwise become stuck on the needle <NUM>. In some instances, the tissue release mechanism <NUM> may be spring-loaded to engage the needle <NUM>, or may be separately and independently actuated. In some instances, the tissue release mechanism <NUM> includes a cross-bar <NUM> that provides an additional surface that can push tissue off of the needle <NUM>.

In preparing the suture device <NUM> for use, the distal assembly <NUM> may be secured to a delivery device such as an endoscope. In some embodiments, an attachment enabler, such as a flexible silicone tube, may be unrolled along the delivery device in order to hold the distal assembly <NUM> in place and to prevent rotation of the distal assembly <NUM> relative to the delivery device. In some embodiments, if desired, the side-saddled lumen attachment element <NUM> (or 120a) may be secured to the distal assembly <NUM>. The suture may be passed through the needle <NUM>, and fed back towards the user interface. The device <NUM> may be extended through the body to the defect site.

<FIG> is a perspective view of a distal assembly 14c that may, for example, be usable in the suture device <NUM> shown in <FIG>. The distal assembly 14c is similar to the distal assembly <NUM> shown in previous Figures, but includes several modifications that may be useful, particularly in bariatric revision procedures. A bariatric procedure commonly refers to a procedure in which the effective useful volume of a patient's stomach may be surgically reduced in order to effect long-term weight loss for the patient and may be performed laparoscopically. A bariatric revision procedure is a procedure, performed endoscopically, in which changes may be made to what was originally done to the patient's stomach. In some embodiments, the distal assembly 14c may also be used in other suturing procedures, such as but not limited to full tissue thickness repairs and/or partial tissue thickness repairs.

The distal assembly 14c may include a body 29a having a proximal connector 30a that may be configured to be coupled to the distal end of an endoscope or other delivery system, for example. In some embodiments, as illustrated, the proximal connector 30a may include a fixation feature such as a fixation flange <NUM>. The body 29a includes an arm 32a that extends to an endcap 34a. In some embodiments, the body 29a, including the arm 32a, may be similar to the body <NUM> and arm <NUM> referenced previously with respect to the distal assembly <NUM>, the distal assembly 14a and the distal assembly 14b. In some instances, however, the body 29a and the arm 32a may be adapted to accommodate thicker tissue, which may for example mean a change in the overall shape of the body 29a and/or the arm 32a relative to the body <NUM> and/or the arm <NUM>. In some embodiments, the body 29a and/or the arm 32a may simply be larger in order to accommodate thicker tissue. The distal assembly 14c may be considered as including a guide member 36a that may be secured to or integrally formed with the body 29a, and may be configured to permit a suture translation assembly (such as the suture translation assembly <NUM>, a suture translation assembly 12a, shown in <FIG>, or a suture translation assembly 12b, shown in <FIG>) to extend through the guide member 36a and to translate relative to the guide member 36a.

In some embodiments, as illustrated, the guide member 36a includes a channel <NUM>. In some embodiments, the channel <NUM> permits a suture to pass between the suture translation assembly <NUM>, 12a, 12b and a working channel of the endoscope or other delivery device to which the distal assembly 14c is attached. The channel <NUM> may, for example, be designed to include a lead in that would help to align the suture with the channel <NUM> when passing the suture translation assembly <NUM>, 12a, 12b through the working channel of the endoscope or other delivery device. In some embodiments, there may be a desire to load the suture before passing the suture translation assembly <NUM>, 12a, 12b through the working channel of the endoscope or other delivery device.

In some instances, the distal assembly 14c includes a guide structure 27a that is attached to or integrally formed with the body 29a. In some embodiments, the guide structure 27a may instead be pivotably attached to the body 29a. The guide structure 27a may be configured to accommodate a polymeric tubular member attached thereof, in order to guide tools through the endoscope and into position relative to the working site. In some instances, the guide structure 27a may be configured to accommodate a metallic tubular member attached thereto. In some embodiments, for example, the guide structure 27a and accompanying tubular member (not illustrated) may accommodate a graspers or similar tool that allows a user to grasp tissue and pull it into position so that the needle <NUM> may be passed through the tissue. In some embodiments, the relative position, or offset of the guide structure 27a, relative to the relative position or offset illustrated with respect to the distal assembly <NUM>, the distal assembly 14a or the distal assembly 14b, may be greater in order to provide more room for tools and/or to accommodate larger and/or thicker portions of tissue.

The end cap 34a includes one or more securement openings 40a that may be, as can be seen, be arranged orthogonally to a proximal needle opening (not illustrated), such as the proximal needle opening <NUM> illustrated for example in <FIG>. One or more securements 42a may correspondingly be disposed within the one or more securement openings 40a. In some embodiments, the one or more securements 42a may be a coil spring that is disposed within the one or more securement openings 40a. The securement 42a may releasably engage a detent on the needle <NUM>, as discussed with respect to the distal assembly <NUM>.

In some embodiments, the securement opening 40a visible on one side (in the illustrated orientation) may have a diameter that is greater than an overall diameter of the securement 42a and the securement opening 40a may taper to a diameter on the opposite side (not seen) that is about the same as the diameter of the securement 42a. In some embodiments, the securement 42a may be welded, soldered, adhesively secured or otherwise attached at the left side of the securement opening 40a, and may be free to move somewhat at the right side of the securement opening 40a. In some instances, the distal assembly 14c may include an opening <NUM> that is orthogonal to the securement opening 40a. The opening <NUM> may be threaded in order to threadedly engage a set screw <NUM>. In some embodiments, as illustrated, the opening <NUM> may be offset closer to the right side of the securement opening 40a, away from the secured end of the securement 42a, such that the set screw <NUM> may be considered as supporting the free end of the securement 42a. Rotating the set screw <NUM> in a first direction, such as clockwise, may cause the set screw <NUM> to translate towards the securement 42a, thereby increasing an interference between the securement 42a and the needle <NUM> and increasing a retentive force that can be applied to the needle <NUM>. Conversely, rotating the set screw in a second direction, such as counter-clockwise, may cause the set screw <NUM> to translate away from the securement 42a, thereby decreasing the retentive force that can be applied to the needle <NUM>. This may help to adjust for manufacturing tolerances, for example.

As noted, the distal assembly 14c may be used in combination with the suture translation assembly <NUM> discussed previously with respect to <FIG>, for example. The distal assembly 14c may also be used with a suture translation assembly 12a, shown in <FIG>, as well as with a suture translation assembly 12b, shown in <FIG>. <FIG> is a perspective view of the suture translation assembly 12a, shown holding the needle <NUM>, while <FIG> is a partially exploded view of the suture translation assembly 12a. As better seen in <FIG>, the suture translation assembly 12a includes an inner member <NUM> that hold the needle <NUM>. A locking member <NUM> is slidingly disposed over the inner member <NUM>. As can be seen, the inner member <NUM> includes a pin <NUM> that extends radially outwardly from the inner member <NUM> and extends through a corresponding slot <NUM> that is formed in the locking member <NUM>. The pin <NUM> serves to prevent relative rotation between the inner member <NUM> and the locking member <NUM>. The pin <NUM> also serves to limit translation of the locking member <NUM> relative to the inner member <NUM>.

A control member <NUM> is secured relative to a proximal end <NUM> of the locking member <NUM>, and extends distally to a handle such as the translating handle <NUM> (<FIG>). As a result, the locking member <NUM> may be translated distally and/or proximally relative to the inner member <NUM>. As seen in <FIG>, the suture translation assembly 12a includes an outer sleeve <NUM> that may be pinned via the pin <NUM> to the inner member <NUM>. The outer sleeve <NUM> may be coupled with a coil <NUM>, for example. In some embodiments, the outer sleeve <NUM> may be a single tubular member. In some embodiments, as shown for example in <FIG>, the outer sleeve <NUM> may actually include one or more of an outer sleeve <NUM>, a slotted sleeve <NUM>, and an inner outer sleeve <NUM>. The slotted sleeve <NUM> may be configured to permit a suture to pass therethrough. This is merely illustrative, and is not intended to be limiting in any fashion.

The inner member <NUM> includes several arms <NUM> that, as seen in <FIG>, which shows the distal portion of the inner member <NUM>, include curved tabs <NUM> that are configured to engage corresponding detents within the needle <NUM>. While a total of four arms <NUM> are shown, it will be appreciated that the inner member <NUM> may include any number of arms <NUM>. It will be appreciated that the arms <NUM> are relatively long in length, and as a result may be considered as being relatively flexible. With the locking member <NUM> extended distally into a locking configuration, as shown for example in <FIG>, the locking member <NUM> prevents outward movement of the arms <NUM>. As a result, the curved tabs <NUM> remain in engagement with the corresponding detents of the needle <NUM>, and the needle <NUM> remains locked to the suture translation assembly 12a. With the locking member <NUM> retracted proximally into an unlocked configuration, as shown for example in <FIG>, the arms <NUM> are free to move radially outwardly, thereby releasing the curved tabs <NUM> from the detents in the needle <NUM>, and allowing the needle <NUM> to move distally relative to the inner member <NUM>.

<FIG> is a perspective view of a suture translation assembly 12b that may be used in combination with any of the distal assembly <NUM>, the distal assembly 14a, the distal assembly 14b and/or the distal assembly 14c. <FIG> is a perspective view of the suture translation assembly 12b with outer portions such as an outer sleeve <NUM> (<FIG>) removed to reveal an inner member <NUM> that holds a needle 16a. In some embodiments, the outer sleeve <NUM> may be a single tubular member. In some instances, the outer sleeve <NUM> may include several elements, such as described with respect to the outer sleeve <NUM> (<FIG>).

In some embodiments, as illustrated, the needle 16a has a distal detent <NUM> and a proximal detent <NUM> (visible in <FIG>) that are shaped differently than the corresponding detents in the needle <NUM>. The suture translation assembly 12b includes a locking member <NUM> that is slidingly disposable relative to the inner member <NUM>. The pin <NUM> is attached to the inner member <NUM> and extends through a corresponding slot <NUM> formed in the locking member <NUM>. The pin <NUM> limits translation of the locking member <NUM> relative to the inner member <NUM>, and also prevents relative rotational movement of the locking member <NUM>. The locking member <NUM> is secured to the control member <NUM>, which extends distally to a handle such as the translating handle <NUM> (<FIG>). As a result, the locking member <NUM> may be translated distally and/or proximally relative to the inner member <NUM>.

In some embodiments, the outer sleeve <NUM> may define a slot <NUM> including an axially extending slot portion <NUM> and a shorter radially extending slot portion <NUM>. In some embodiments, the axially extending slot portion <NUM> permits the pin <NUM> to move within the axially extending slot portion <NUM> in order to permit the needle 16a to be fully withdrawn into the suture translation assembly 12b for advancement through an endoscope or other delivery device. Once the suture translation assembly 12b has been advanced through the endoscope or other delivery device, the inner member <NUM> and the locking member <NUM> may be advanced distally through the outer sleeve <NUM> until the pin <NUM> aligns with the radially extending slot portion <NUM>. By rotating the translating handle <NUM>, the pin <NUM> may be rotated into position within the radially extending slot portion <NUM> so that the locking member <NUM> may be translated relative to the inner member <NUM>.

In some embodiments, as illustrated, the locking member <NUM> includes a pair of arms <NUM> that extend distally from the locking member <NUM>. As seen for example in <FIG>, the arms <NUM> include tabs <NUM> that, when the suture translation assembly 12b is in a locked configuration as shown in <FIG> and <FIG>, the tabs <NUM> extend through slots <NUM> formed within the inner member <NUM>. As a result, the tabs <NUM> are able to extend through the slots <NUM> and engage the proximal detent <NUM> of the needle 16a. While a pair of arms <NUM> are illustrated, it will be appreciated that the locking member <NUM> may include any number of arms <NUM>, and of course a corresponding number of slots <NUM>.

In order to move the suture translation assembly 12b into an unlocked configuration, as shown for example in <FIG>, the locking member <NUM> may be moved distally relative to the inner member <NUM>. As can be seen in <FIG>, the tabs <NUM> have moved out of the slots <NUM> (only one slot <NUM> is seen), and the needle 16a is free to move relative to the suture translation assembly 12b. As the locking member <NUM> moves distally, angled surfaces <NUM> push against the slots <NUM> and are moved outwardly.

In some embodiments, and with respect to <FIG>, the guide member 36a includes a channel <NUM> that is configured to permit a suture to pass between the suture translation assembly <NUM>, 12a, 12b and a working channel of the endoscope or other delivery device to which the distal assembly 14c is attached. The channel <NUM> may, for example, be designed to include a lead in that would help to align the suture with the channel <NUM> when passing the suture translation assembly <NUM>, 12a, 12b through the working channel of the endoscope or other delivery device. In some embodiments, there may be a desire to load the suture before passing the suture translation assembly <NUM>, 12a, 12b through the working channel of the endoscope or other delivery device.

In some instances, as shown for example in <FIG>, instead of putting a channel <NUM> in the guide member 36a, the suture translation assembly <NUM>, 12a, 12b may be modified to accommodate a suture passing along the suture translation assembly <NUM>, 12a, 12b. <FIG> is a perspective view of a sleeve 20a that may be used in forming a part of the suture translation assembly <NUM>, 12a, 12b. It can be seen that the sleeve 20a includes a groove 20b that extends a length of the sleeve 20a. <FIG> shows the sleeve 20a extending through the guide member 36a, with a suture <NUM> extending through the groove 20b.

In some embodiments, movement of the suture translation assembly <NUM>, 12a, 12b relative to the distal assembly <NUM>, 14a, 14b, 14c, particularly as the needle <NUM>, 16a is passed back and forth between the suture translation assembly <NUM>, 12a, 12b and the distal assembly <NUM>, 14a, 14b, 14c, may potentially interfere with securement of the distal assembly <NUM>, 14a, 14b, 14c relative to the endoscope or other delivery system. <FIG> is a perspective view of the distal assembly 14c coupled to a split ring attachment mechanism <NUM> and <FIG> is a cross-sectional view thereof, taken along line <NUM>-<NUM> of <FIG>. <FIG> is a perspective view of the split ring attachment mechanism <NUM>. In some embodiments, and as will be discussed in greater detail, the split ring attachment mechanism <NUM> may be considered as including an endoscope engaging portion <NUM> that is adapted to engage an endoscope in a compressive fit and a distal endcap engaging portion <NUM> that is adapted to engage the distal endcap, or distal assembly 14c, in an interference fit. It will be appreciated that the split ring attachment mechanism <NUM> may be used in combination with any of the distal assemblies <NUM>, 14a, 14b, 14c. While discussed and illustrated with respect to use with the suture device <NUM>, it will be appreciated that the split ring attachment mechanism <NUM> may be used in combination with other devices that one may wish to releasably secure to an endoscope or other delivery system.

In some embodiments, the split ring attachment mechanism <NUM> may be considered as including an elongate body <NUM> that largely defines the endoscope engaging portion <NUM>. In some embodiments, as seen for example in <FIG> and <FIG>, the elongate body <NUM> includes an inner surface <NUM> that may be considered as being adapted to frictionally engage an outer surface of an endoscope to which the split ring attachment mechanism <NUM> is being secured. In some embodiments, the elongate body <NUM> may have a length that is selected to provide a maximum amount of surface area for the inner surface <NUM> while not interfering with the flexibility of the endoscope or other delivery system. The overall dimensions of the elongate body <NUM> may vary, depending on particulars of the endoscope to which it will be attached, but in some embodiments the elongate body <NUM> may have an overall length that is in a range of about <NUM> inches to about <NUM> inches and a diameter that is in a range of about <NUM> inches to about <NUM> inches, wherein <NUM> inch equals <NUM>.

While the inner surface <NUM> is shown as having a largely cylindrical profile, for being secured to an endoscope having a largely cylindrical outer surface, it will be appreciated that in some embodiments the elongate body <NUM> and/or the inner surface <NUM> thereof may have a different profile that is complementary to an endoscope having a non-cylindrical outer surface, for example.

In some embodiments, the split ring attachment mechanism <NUM> may include an annular slot <NUM> that is complementary in position and dimension in order to accommodate the fixation feature or flange <NUM> that forms part of the proximal connector <NUM>. As can be seen in <FIG>, when the split ring attachment mechanism <NUM> is in its locked configuration (as illustrated), the fixation feature or flange <NUM> fits into the annular slot <NUM> and limits relative axial movement of the distal assembly 14c relative to the split ring attachment mechanism <NUM> and thus limits relative axial movement of the distal assembly 14c relative to the endoscope or other delivery system to which the split ring attachment mechanism <NUM> and the distal assembly 14c are secured. As alluded to, the split ring attachment mechanism <NUM> may be considered as being movable between a locked configuration in which the split ring attachment mechanism <NUM> is locked to the distal assembly 14c and an engagement configuration that enables the split ring attachment mechanism <NUM> to be advanced radially over an endoscope and a distal assembly such as the distal assembly 14c already attached to the endoscope. In some embodiments, the split ring attachment mechanism <NUM> may be separately secured to the distal assembly 14c, and the combination may be axially advanced over a distal end of the endoscope or other delivery system.

<FIG> is a cross-sectional view of a proximal portion of the split ring attachment mechanism <NUM> illustrating the locked configuration while <FIG> is a similar view illustrating the engagement configuration. In <FIG>, the elongate body <NUM> may be seen as having a first body portion or clamping portion <NUM> and a second body portion or clamping portion <NUM>. A living hinge <NUM> enables the first clamping portion <NUM> and the second clamping portion <NUM> to move from the locked configuration shown in <FIG> to the engagement configuration shown in <FIG>. It will be appreciated that in the engagement configuration, the split ring attachment mechanism <NUM> may be radially advanced over an endoscope and a distal assembly secured to the endoscope. In some embodiments, as shown for example in <FIG>, that the first clamping portion <NUM> and the second clamping portion <NUM> extend along a circle C when in the locking configuration as shown. In <FIG>, it can be seen that the first clamping portion <NUM> and the second clamping portion <NUM> are deflected away from the locking configuration, and are deflected outwardly away from the circle C.

In some embodiments, as shown, the living hinge <NUM> may simply be a thinner portion of the elongate body <NUM> that provides additional flexibility relative to the rest of the elongate body <NUM>. In some embodiments, the living hinge <NUM> may be considered as extending longitudinally along the elongate body <NUM>, as shown in <FIG>, where the living hinge <NUM> may be seen as extending from a proximal end <NUM> of the split ring attachment mechanism <NUM> to a distal end <NUM> of the split ring attachment mechanism <NUM>. In some instances, a mechanical hinge in which the first clamping portion <NUM> and the second clamping portion <NUM> come together in a pivoting fashion may be used in place of the living hinge <NUM>.

As will be appreciated, once the split ring attachment mechanism <NUM> has been opened up, as shown in <FIG>, and advanced radially over the endoscope and the distal assembly 14c disposed thereon, the split ring attachment mechanism <NUM> may be moved back into the locking configuration shown in <FIG>. In some instances, while not illustrated, any variety of fastening mechanisms may be used to hold the split ring attachment mechanism <NUM> into the locking configuration. For example, a ratcheting mechanism may be used. In some embodiments, as shown, the split ring attachment mechanism <NUM> may be configured to accommodate one or more elastic members, such as but not limited to O-rings or rubber bands, to hold the split ring attachment mechanism <NUM> in the locking configuration but also to provide a compressive force such that the inner surface <NUM> frictionally engages the outer surface of the endoscope or other delivery system. In order to accommodate one or more elastic members, the split ring attachment mechanism <NUM> may include hooks.

As illustrated in <FIG>, the split ring attachment mechanism <NUM> includes a first pair of opposing hooks <NUM> and <NUM> as well as a second pair of opposing hooks <NUM> and <NUM>. In other cases, the split ring attachment mechanism <NUM> may only have a single pair of hooks, or may have two, three or more pairs of hooks. The hook <NUM> extends from the first clamping portion <NUM> while the hook <NUM> extends from the second clamping portion <NUM>. It will be appreciated that an elastic member (not shown in <FIG>) may engage the hook <NUM>, extend radially around the split ring attachment mechanism <NUM> opposite the living hinge <NUM>, and engage the hook <NUM>. Similarly, another elastic member may engage the hook <NUM>, which also extends from the first clamping portion <NUM>, extend radially around the split ring attachment mechanism <NUM> opposite the living hinge <NUM>.

In some embodiments, as shown in <FIG>, the split ring attachment mechanism <NUM> may be configured to accommodate the elastic members. For example, the split ring attachment mechanism <NUM> may include annular grooves <NUM> and <NUM> in order to accommodate an elastic member extending between the hook <NUM> and the hook <NUM>. Similarly, the split ring attachment mechanism <NUM> may include annular grooves <NUM> and <NUM> in order to accommodate an elastic member extending between the hook <NUM> and the hook <NUM>. It will be appreciated that in some embodiments, the annular grooves <NUM>, <NUM> and <NUM>, <NUM> may help keep the elastic members from migrating axially relative to the split ring attachment mechanism <NUM>. In some embodiments, the annular grooves <NUM>, <NUM> and <NUM>, <NUM> also help to minimize a diameter increase otherwise caused by the elastic members extending around the split ring attachment mechanism <NUM>.

In some embodiments, as seen for example in <FIG> and <FIG>, the hooks <NUM>, <NUM>, <NUM>, <NUM> may be configured to provide a frictional engagement with the elastic members. As can be seen, for example, each of the hooks <NUM>, <NUM> and <NUM>, <NUM> include a recess <NUM> configured to accommodate a diameter of an elastic member and an opening <NUM> to the recess <NUM> that is smaller than a diameter of the recess <NUM>. This helps to hold the elastic members in place relative to the hooks <NUM>, <NUM> and <NUM>, <NUM>. The recess <NUM> and the opening <NUM> are not labeled on <FIG> due to the orientation of the drawing, but are clearly visible.

<FIG> is a perspective view of an assembly <NUM> that includes the distal assembly 14c secured to the end of an endoscope <NUM> via the split ring attachment mechanism <NUM>. The assembly <NUM> includes a first elastic member <NUM> that extends from the hook <NUM> to the hook <NUM> and a second elastic member <NUM> that extends from the hook <NUM> to the hook <NUM>. As a result of the first elastic member <NUM> and the second elastic member <NUM>, the split ring attachment mechanism <NUM> is able to provide a compressive force against the outer surface of the endoscope <NUM>, and thus the inner surface <NUM> of the split ring attachment mechanism <NUM> is able to provide a frictional force against the outer surface of the endoscope <NUM> that helps to anchor the split ring attachment mechanism <NUM> in place.

<FIG> is a perspective view of a split ring attachment mechanism 403a that is similar to the split ring attachment mechanism <NUM>, but includes a clip <NUM> that may help to hold and/or secure an external lumen or working channel. In some embodiments, the clip <NUM> includes an engagement feature <NUM> that is configured to releasably secure an external lumen or working channel (not illustrated) in a snap fit. In some instances, as shown, the clip <NUM> also includes a body portion <NUM> that spaces the engagement feature <NUM> away from the split ring attachment mechanism 403a. While the clip <NUM> is illustrated as spanning the living hinge <NUM>, in some embodiments the clip <NUM> may be radially offset from the illustrated position.

<FIG> is a perspective view of a split ring attachment mechanism 403b and <FIG> is a cross-sectional view of the split ring attachment mechanism 403b. The split ring attachment mechanism 403b includes an elongate body 409a that is divided into a first clamping portion 420a and a second clamping portion 422a by an elongate living hinge 424a. A hook 434a extends from the first clamping portion 420a and a corresponding hook 436a extends from the second clamping portion 422a. The split ring attachment mechanism 403b includes an elongate body 409a that defines the annular slot <NUM> as well as a pair of annular grooves 444a and 446a that are configured to accommodate an O-ring or other elastic member to secure the split ring attachment 403b in its locking configuration (as shown) by extending around the elongate body 409a from the hook 434a to the hook 436a.

It can be seen that the first clamping portion 420a is relatively smaller than the second clamping portion 422a, as the elongate living hinge 424a is offset relative to a position of the living hinge <NUM> as seen in <FIG> or <FIG>, for example. In some embodiments, the first clamping portion 420a and the second clamping portion 422a may, in comparison to the first clamping portion <NUM> and the second clamping portion <NUM> (seen in <FIG> and <FIG>, for example) may not extend circumferentially about the endoscope as far as the first clamping portion <NUM> and the second clamping portion <NUM>. In some embodiments, having the elongate living hinge 424a be offset better facilitates placing the first clamping portion 420a and the second clamping portion 422a about the endoscope or other delivery system. In some embodiments, offsetting the elongate living hinge 424a relative to the clip <NUM> means that the clip <NUM> does not potentially impact the flexibility of the elongate living hinge 424a.

The split ring attachment mechanism <NUM>, 403a, 403b may be made of any suitable material. In some embodiments, the split ring attachment mechanism <NUM>, 403a, 403b may be made of a polymer such as but not limited to PEEK (polyetheretherketone), ABS (acrylonitrile butadiene styrene), polycarbonate, rubber, silicone, thermoplastic elastomers such as but not limited to PEBA (polyether block amide), available under the PEBAX® name, SLA and others.

<FIG> illustrate a split ring attachment mechanism <NUM>, 403a that may be used to releasably secure the distal endcap <NUM>, 14a, 14b, 14c to the distal end of the endoscope <NUM>. It will be appreciated that other attachment mechanisms may also be used. <FIG> provide illustrative but non-limiting examples of attachment mechanisms that are disposable over an exterior of the endoscope <NUM> proximate a distal end thereof in order to releasably secure the distal endcap relative to the distal end of the endoscope <NUM>. In some embodiments, for example, a suitable attachment mechanism may include an inner collet member <NUM> as shown in <FIG> that is configured to engage the distal endcap <NUM>, 14a, 14b, 14c and form a compressive fit with the endoscope <NUM>. A suitable attachment mechanism may also include an outer collet member <NUM> as shown in <FIG> that is configured to engage the inner collet member <NUM> in order to form the compressive fit between the inner collet member <NUM> and the endoscope <NUM>.

As seen in <FIG>, the inner collet member <NUM> includes an annular ring portion <NUM>. In some embodiments, the annular ring <NUM> defines or otherwise includes an annular groove <NUM> that is configured to accommodate the fixation feature <NUM> present on the distal endcap <NUM>, 14a, 14b, 14c. The fixation feature <NUM> is visible, for example, in <FIG>. It will be appreciated that the interaction between the annular groove <NUM> and the fixation feature <NUM> may secure the inner collet member <NUM> to the distal endcap <NUM>, 14a, 14b, 14c. The inner collet member <NUM> includes a number of fingers <NUM> that are adapted to interact with an outer surface of the endoscope <NUM> to provide a compressive fit between the inner collet member <NUM> and the endoscope <NUM>. In some embodiments, the fingers <NUM> may be considered as extending axially from the annular ring <NUM> in a proximal direction. As illustrated, the inner collet member <NUM> includes a total of four fingers 606a, 606b, 606c and 606d. In some embodiments, the inner collet member <NUM> may have more than four fingers <NUM>, or may have fewer than four fingers <NUM>.

In some embodiments, as shown, the fingers <NUM> each include a threaded portion <NUM> that corresponds to threading on the outer collet member <NUM>. The inner collet member <NUM> includes slots <NUM> disposed between adjacent fingers <NUM> such that the fingers <NUM> can bend inwardly as the outer collet member <NUM> is threaded over the inner collet member <NUM>. It will be appreciated that the fingers <NUM> collectively define an inner surface <NUM> of the inner collet member <NUM>. <FIG> and <FIG> are schematic cross-sections of the inner collet member <NUM>. In <FIG>, the inner surface <NUM> may be seen as defining a constant diameter cylinder while in <FIG>, the inner surface <NUM> is divided in to a first section 614a and a second section 614b, where the second section 614b defines a reduced-diameter cylinder relative to that defined by the first section 614a. In some embodiments, having a reduced-diameter portion helps with securing to a relatively smaller diameter endoscope <NUM>, for example, and in some embodiments can lead to an increased surface contact area between the inner collet member <NUM> and the endoscope <NUM>.

Returning briefly to <FIG>, the outer collet member <NUM> includes an outer knurled surface <NUM> that facilitates grasping and turning the outer collet member <NUM> relative to the inner collet member <NUM>. The outer collet member <NUM> also includes a threaded inner surface <NUM> that engages the threaded portions <NUM> of each of the fingers <NUM> of the inner collet member <NUM>. <FIG> and <FIG> illustrate the inner collet member <NUM> and the outer collet member <NUM> in a detached and attached configuration, respectively, with an endoscope <NUM>. The inner collet member <NUM> and the outer collet member <NUM> may secure a distal endcap such as the distal endcap 14c to the endoscope <NUM>.

As can be seen in <FIG>, the inner collet member <NUM> is positioned in engagement with the distal endcap 14c. While not visible, the fixation feature <NUM> may be engaged within the annular groove <NUM> to secure the inner collet member <NUM> to the distal endcap 14c. In some embodiments, the distal endcap <NUM> may be attachable to the endoscope <NUM> via the collet members <NUM>, <NUM> by any configuration, e.g., tongue and groove, pins, and the like, so that the distal endcap <NUM> is secured to the endoscope <NUM> for performing a medical procedure. The outer collet member <NUM> is seen disposed over the endoscope <NUM>. By moving the outer collet member <NUM> in a direction indicated by an arrow <NUM>, the outer collet member <NUM> engages the inner collet member <NUM>. Rotating the outer collet member <NUM> causes the outer collet member <NUM> to threadedly engage the inner collet member <NUM>. As the outer collet member <NUM> continues to translate in the direction indicated by the arrow <NUM>, the outer collet member <NUM> forces the fingers <NUM> into a compressive fit with the endoscope <NUM>. <FIG> shows the distal endcap 14c secured to the endoscope <NUM> via the interaction between the inner collet member <NUM> and the outer collet member <NUM>.

<FIG> shows an inner collet member 600a that is integrally formed with a distal endcap 14d. Operation is otherwise the same as that described with respect to <FIG> and <FIG>. In some embodiments, the inner collet member 600a may be integrally molded as part of the distal endcap 14d. In some instances, the inner collet member 600a may be adhesively secured to the distal endcap 14d. The inner collet member 600a may be separately formed, and then snap fit onto the distal endcap 14d. These are just examples.

<FIG> and <FIG> show a distal endcap 14e that includes a number of proximally extending fingers <NUM>. A ring <NUM> may be moved proximally, in a direction indicated by an arrow <NUM>. As the ring <NUM> is moved proximally, the ring <NUM> compresses the proximally extending fingers <NUM> into a compressive fit with the endoscope <NUM>. In some embodiments, the ring <NUM> may be a rigid ring. In some instances, the ring <NUM> may be elastomeric, and thus can stretch as the ring <NUM> is advanced proximally over the fingers <NUM>, and thus can provide a compressive force on the fingers <NUM>. <FIG> shows the distal endcap 14e secured to the endoscope <NUM>.

<FIG> is a perspective view of an attachment mechanism <NUM> that in some ways is similar to the split ring attachment mechanism <NUM> described with respect to previous Figures. The attachment mechanism <NUM> includes a body <NUM> that is curved to fit part way around an endoscope such as the endoscope <NUM>. The attachment mechanism <NUM> includes an annular ring portion <NUM> that extends radially around a greater distance than the body <NUM>. While not visible, in some embodiments, the annular ring portion <NUM> includes a groove similar to the annular groove <NUM> that is configured to engage the fixation feature <NUM> of distal endcap <NUM>, 14a, 14b, 14c. The attachment mechanism <NUM> includes hooks <NUM> and <NUM> extending radially outwardly from the body <NUM>. The hooks <NUM> and <NUM> may accommodate an elastomeric member extending from the hook <NUM>, around the endoscope <NUM> and to the hook <NUM>.

<FIG> is a perspective view of a distal endcap 14f secured to the endoscope <NUM>. The distal endcap 14f includes a fixation member <NUM> extending radially outwardly from the distal endcap 14f. The fixation member <NUM> may be integrally formed with the distal endcap 14f, for example, or may be adhesively secured to the distal endcap 14f. An elastomeric sleeve <NUM> may be configured to be stretched over the endoscope <NUM> to provide a compressive fit between the elastomeric sleeve <NUM> and the endoscope <NUM>. In some embodiments, as shown, the elastomeric sleeve <NUM> includes a fixation aperture <NUM> that accommodates the fixation member <NUM> extending therethrough. It will be appreciated that the fixation member <NUM> and the fixation aperture <NUM> together provide an interference fit. While the fixation member <NUM> and the fixation aperture <NUM> are both illustrated as having a rectilinear shape, this is merely illustrative, as the fixation member <NUM> and the fixation aperture <NUM> may take any desired shape. In some embodiments, the distal endcap 14f may include two or more fixation members <NUM> and the elastomeric sleeve <NUM> may include two or more corresponding fixation apertures <NUM>.

<FIG> is a perspective view of an attachment mechanism <NUM> securing the distal endcap 14c to the endoscope <NUM>. The attachment mechanism <NUM> is similar to the split ring attachment mechanism <NUM>, 403a and includes a body <NUM>. The body <NUM> defines annular grooves <NUM> and <NUM> for accepting snap rings <NUM> and <NUM>, respectively. The snap rings <NUM>, <NUM> are flexible enough to open sufficiently to fit over the body <NUM> and into the annular grooves <NUM>, <NUM>, respectively, and then reclose to provide a compressive force on the body <NUM> to close a gap <NUM> and thus provide a compressive fit between the attachment mechanism <NUM> and the endoscope <NUM>. While not illustrated, the attachment mechanism <NUM> may have an interference fit with the endoscope <NUM>.

<FIG> and <FIG> illustrate an attachment mechanism <NUM>. The attachment mechanism <NUM> includes a number of hook members <NUM> that can be secured to the endoscope <NUM>. Each of the hook members <NUM> includes a hook end <NUM> that is configured to fit into corresponding slots <NUM> that are formed in a distal endcap <NUM>. With a ring <NUM> positioned as shown in <FIG>, the hook members <NUM> are free to rotate as indicated by arrows <NUM>. As a result, the hook ends <NUM> can be inserted into the slots <NUM>. By moving the ring <NUM> distally in a direction indicated by an arrow <NUM>, the ring <NUM> prevents the hook ends <NUM> from backing out of the slots <NUM>, thereby securing to the distal endcap <NUM>.

<FIG> is a side view of an attachment mechanism <NUM> that includes a mounting feature <NUM> extending proximally from a distal endcap <NUM> and an adaptor <NUM> that is configured to be secured to the endoscope <NUM>. The adaptor <NUM> includes radially extending pegs <NUM> that fit into corresponding holes <NUM> that are formed in the mounting feature <NUM>. In some embodiments, this may be reversed, with the holes <NUM> formed in the adaptor <NUM> and the pegs <NUM> formed on the mounting feature <NUM>.

<FIG> is a side view of an attachment mechanism <NUM> that includes a mounting feature <NUM> extending proximally from a distal endcap 14i and an adaptor <NUM> that is configured to be secured to the endoscope <NUM>. The adaptor <NUM> includes axially extending pegs <NUM> that fit into corresponding holes <NUM> that are formed in the mounting feature <NUM>. In some embodiments, this may be reversed, with the holes <NUM> formed in the adaptor <NUM> and the pegs <NUM> formed on the mounting feature <NUM>.

<FIG> is a side view of an attachment mechanism <NUM> that may be used for securing a distal endcap to the endoscope <NUM>. The attachment mechanism <NUM> has a body <NUM> that is configured to fit around the endoscope <NUM> and a distal endcap (not shown). As can be seen, the body <NUM> defines a slot <NUM> that facilitates placement of the attachment mechanism <NUM>. Once placed, a pair of zip ties <NUM> may be used to compress the attachment mechanism <NUM> onto the endoscope, narrowing the slot <NUM>.

<FIG> is a side view of an attachment mechanism <NUM> that may be used for securing a distal endcap to the endoscope <NUM>. In simple terms, the attachment mechanism <NUM> may be considered as an example of a Chinese finger trap. The attachment mechanism <NUM> is a cylindrical, helically wound braid. Shortening the attachment mechanism <NUM> in an axial direction causes the attachment mechanism <NUM> to expand radially. In this configuration, the attachment mechanism <NUM> may be disposed over an endoscope and a distal endcap. Stretching the attachment mechanism <NUM> axially causes the attachment mechanism <NUM> to compress radially, which can secure the attachment mechanism <NUM> to both the endoscope <NUM> and the distal endcap. It will be appreciated that any further axial stretching, as would occur if the distal endcap moves away from the endoscope <NUM> during use, would further compress the attachment mechanism <NUM> radially.

Figure <NUM> is a side view of a distal endcap 14j secured relative to the endoscope <NUM>. The distal endcap 14j includes a fixation feature <NUM> that interacts with a sleeve <NUM> that is disposed over the endoscope <NUM>. The sleeve <NUM> and the fixation feature <NUM> together provide a bearing ball quick-release feature similar to that used in connecting pressurized air hoses, for example.

It will be appreciated that a variety of different materials may be used in forming the devices described herein. In some embodiments, 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 embodiments, for example, the devices described herein may include any suitable polymeric material, including biocompatible materials such as polyurethane or silicone. 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 assembly for use in combination with an endoscope (<NUM>) having a working channel and a distal end, the suture assembly comprising:
a translation assembly (<NUM>) axially translatable within the working channel and adapted to releasably engage and disengage a needle (<NUM>);
a distal endcap (<NUM>, 14a, 14b, 14c) securable to the distal end of the endoscope (<NUM>) and adapted to releasable engage the needle (<NUM>) when the translation assembly (<NUM>) disengages the needle (<NUM>) and to disengage the needle (<NUM>) when the translation assembly (<NUM>) engages the needle (<NUM>), the distal endcap (<NUM>, 14a, 14b, 14c) including a fixation flange (<NUM>) disposed near a proximal end of the distal endcap (<NUM>, 14a, 14b, 14c); said suture assembly being characterized in that it further comprises
an inner collet member (<NUM>, 600a) that is configured to engage the distal endcap (<NUM>, 14a, 14b, 14c) and form a compressive fit with the endoscope (<NUM>); and
an outer collet member (<NUM>) that is configured to engage the inner collet member (<NUM>, 600a) in order to form the compressive fit between the inner collet member (<NUM>, 600a) and the endoscope (<NUM>).