Patent Description:
The disclosure is directed to devices for suturing tissue and more particularly to devices that work with an endoscope or similar device for endoscopically suturing tissue.

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 repairs such as 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> discloses a suture device that may include a suture translation assembly configured to be axially translatable within a lumen of a delivery system and a distal assembly configured to be securable to the distal end of the delivery system. The suture translation assembly and the distal assembly may cooperate to enable a user to pass a needle back and forth between the two in order to endoscopically suture a defect.

<CIT> discloses medical systems, devices and methods for suturing a perforation in tissue, that may be employed endoscopically and/or laparoscopically, and that offer simple, reliable and controllable placement of suture around a perforation for complete closure thereof. One embodiment of the medical system generally includes an endoscope, an endcap, a needle, a suture, and first and second grip systems configured for relative translation to selectively pass the needle between the first and second grip systems.

The disclosure is directed to designs, materials and methods of devices for endoscopically closing large defects. An example is a suture device for use in combination with an endoscope. The suture device includes a needle that is configured to carry a suture, the needle having a distal end. A needle cap is configured to releasably fit over the distal end of the needle.

More specifically, the claimed invention is directed towards a suture device for use in combination with an endoscope having a working channel and a distal end as defined by the appended independent claim <NUM>. The suture device comprises a suture translation assembly configured to be axially translatable within the working channel of the endoscope, wherein the suture translation assembly includes: a needle that is configured to carry a suture, the needle including a distal end and a distal detent near the distal end, a distal shuttle configured to releasably secure the needle, and a sleeve disposable over the distal shuttle, the sleeve 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. The suture device also includes a distal assembly configured to be secured to the distal end of the endoscope and comprising a distal endcap, wherein the suture translation assembly extends into the distal assembly. The suture device further comprises a needle cap which is configured to releasably fit over the distal end of the needle, wherein the needle cap is configured to be pushed off the needle inside the patient.

Alternatively or additionally, the needle cap may be formed of a biocompatible polymer.

Alternatively or additionally, the needle cap may be formed of a biosorbable polymer.

Alternatively or additionally, the needle cap may include a cylindrical needle cap body defining a void that is configured to fit over the needle and an atraumatic distal tip.

Alternatively or additionally, the needle cap may further include one or more elongate slots extending axially within the cylindrical needle cap body.

Alternatively or additionally, the needle cap may further include one or more convex protuberances extending into the void, the one or more convex protuberances configured to fit into the distal detent of the needle.

Alternatively or additionally, the needle cap may be configured to be pushed off of the needle by moving the sleeve distally.

Also disclosed is a suture device for use in combination with an endoscope having a working channel and a distal end, which includes a translation assembly that is configured to be axially translatable within the working channel and that includes a needle configured to carry a suture, a distal shuttle that is 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, the sleeve including an elongate groove extending axially along the sleeve, the elongate groove configured to accommodate the suture extending therethrough. The suture device includes a distal endcap that is securable to the distal end of the endoscope and is configured to engage the needle when the needle is advanced distally into the distal endcap and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is withdrawn proximally.

Alternatively or additionally, the distal shuttle may include a distal needle opening that is configured to accommodate the needle when the distal shuttle is advanced distally over the needle, one or more bearing ball openings arranged orthogonal to the distal needle opening such that the one or more bearing ball openings align with a proximal detent of the needle when the needle is secured to the distal shuttle, and one or more bearing balls that are disposed within the one or more bearing ball openings and disposable within the proximal detent when the needle is secured to the distal shuttle.

Alternatively or additionally, the sleeve may include one or more sleeve openings that are smaller in diameter than the one or more bearing balls. When in the locked position, the one or more sleeve openings are misaligned with the one or more bearing ball openings such that the one or more bearing balls engage the proximal detent of the needle, and when in the unlocked position, the one or more sleeve openings are aligned with the one or more bearing ball openings such that the one or more bearing balls can move radially outward a distance sufficient to permit the one or more bearing balls to clear the proximal detent of the needle.

Further disclosed yet is a suture device for use in combination with a delivery system including a lumen extending through the delivery system, which includes a suture translation assembly that is configured to be axially translatable within the lumen of the delivery system and that includes a needle usable to carry a suture and a distal shuttle configured to releasably secure the needle. A sleeve is disposable over the distal shuttle and is movable relative to the sleeve between a locked position in which the needle is locked to the distal shuttle and an unlocked position in which the needle is releasable from the distal shuttle. A suture catheter is operably coupled to the sleeve and a control wire is operably coupled to the distal shuttle. A distal endcap is configured to be securable to the distal end of the delivery system and to releasably engage and disengage the needle, the endcap 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.

Alternatively or additionally, moving the control wire proximally may cause the distal shuttle to move proximally relative to the sleeve, thereby locking the needle to the distal shuttle.

Alternatively or additionally, moving the control wire distally may cause the distal shuttle to move distally relative to the sleeve, thereby releasing the needle from the distal shuttle.

Alternatively or additionally, the needle may include a distal region and a proximal region, the distal region including a distal detent for releasably engaging the distal endcap and the proximal region including a proximal detent for releasably engaging the distal shuttle.

Alternatively or additionally, the distal shuttle may include one or more bearing ball openings that are arranged to align with the proximal detent when the needle is secured to the distal shuttle and one or more bearing balls that are disposed within the one or more bearing ball openings and are disposable within the proximal detent when the needle is secured to the distal shuttle.

Alternatively or additionally, the sleeve may include one or more sleeve openings smaller in diameter than the one or more bearing balls. When in the locked position, the one or more sleeve openings are misaligned with the one or more bearing ball openings such that the one or more bearing balls engage the proximal detent of the needle and when in the unlocked position, the one or more sleeve openings are aligned with the one or more bearing ball openings such that the one or more bearing balls can move radially outward a distance sufficient to permit the one or more bearing balls to clear the proximal detent of the needle.

Alternatively or additionally, the suture device may further include a yoke that is operably coupled to the control wire, the yoke coupling the control wire to the distal shuttle via a pin that extends through the yoke and translates along a pair of slots formed in the sleeve.

Alternatively or additionally, the suture catheter may include a coil, and the coil is operably coupled to the sleeve.

Alternatively or additionally, the sleeve may be welded to the coil.

Alternatively or additionally, the control wire may extend through the suture catheter.

Alternatively or additionally, the suture device may further include a user interface that is operably coupled to the suture catheter and the control wire, the user interface configured to permit a user to move the control wire, and thus the distal shuttle, relative to the suture catheter.

Also disclosed is a suture device for use in combination with a delivery system including a lumen extending through the delivery system, which includes a needle usable to carry a suture and a distal shuttle that is configured to releasably secure the needle. A sleeve is disposable over the distal shuttle and the distal shuttle is movable relative to the sleeve between a locked position in which the needle is locked to the distal shuttle and an unlocked position in which the needle is releasable from the distal shuttle. A shaft is operably coupled to the sleeve and a control wire extends through the shaft and is operably coupled to the distal shuttle. A distal endcap is configured to be securable to a distal end of the delivery system and to releasably engage and disengage the needle, the endcap 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.

Alternatively or additionally, the suture device may further include a user interface that is configured to allow a user to manipulate the control wire relative to the shaft in order to move the distal shuttle between its locked position and its unlocked position.

The above summary is not intended to describe each disclosed embodiment or every implementation of the present disclosure.

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 scope of the claimed invention is defined by the appended set of claims.

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. 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 cases, the suture device <NUM> will have a proximal handle (not shown) that allows the user to create relative movement between the sleeve <NUM> and the distal shuttle <NUM>. The proximal handle may provide an indication to the user of the relative position of the sleeve <NUM> and the distal shuttle <NUM>. In some cases, the proximal handle may include a soft detent or other feature that informs the user when the needle <NUM> is locked relative to the distal shuttle <NUM> and when the needle <NUM> is not locked relative to the distal shuttle <NUM>.

In some cases, the sleeve <NUM> and the distal shuttle <NUM> may be modified to provide a more robust indication of when the needle <NUM> is locked to the distal shuttle <NUM> and when the needle <NUM> is not locked to the distal shuttle <NUM>. In particular reference to <FIG>, in some cases the sleeve openings <NUM> may be moved a short distance proximally relative to the position shown in <FIG>. In some cases, the internal void <NUM>, which is formed within the distal shuttle <NUM>, may be shortened. In combination, these two changes can provide a more robust indication of when the needle <NUM> is locked to the distal shuttle <NUM> and when the needle <NUM> is not locked to the distal shuttle <NUM>. Moving the sleeve <NUM> fully in one direction means that the needle <NUM> is locked to the distal shuttle <NUM>. Moving the sleeve <NUM> fully in the opposite direction means that the needle <NUM> is not locked to the distal shuttle <NUM>. This can provide a simple, binary locked/unlocked indication to the user.

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 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 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 an opposing 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 a translating handle. 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 a translating handle. 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 a translating handle, 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, there may be a desire to protect the distal end of the needle <NUM> when advancing the suture translation assembly <NUM>, 12a, 12b through a delivery system such as an endoscope. In some embodiments, the needle <NUM> may otherwise be able to damage a working channel with the endoscope, for example. In some instances, there may be a desire to protect the needle <NUM> itself from becoming damaged. In some embodiments, the sleeve <NUM>, 20a covering the needle <NUM> and the distal shuttle <NUM> (<FIG>) may be dislodged proximally during loading, resulting in possible exposure of the needle <NUM>. In some embodiments, it may be difficult to load through a bend in the working channel of the endoscope when the sleeve <NUM>, 20a is extended over the needle <NUM>.

<FIG> and <FIG> illustrate an example in which a needle cap <NUM> has been placed over the distal region <NUM> of the needle <NUM>. <FIG> is a side view while <FIG> is a cross-sectional view taken along line <NUM>-<NUM> of <FIG>. In some embodiments, the needle cap <NUM> may be removed outside of the patient, after the suture translation assembly <NUM>, 12a, 12b has been loaded into the endoscope but before the endoscope has been inserted into the patient. In some embodiments, the needle cap <NUM> may be pushed off of the needle <NUM> inside the patient. When performing a procedure utilizing multiple needles and sutures, such as but not limited to endoscopic sleeve gastroplasty, it may be desirable to remove the needle cap <NUM> with the endoscope inside the patient so that the endoscope does not have to be removed and inserted multiple times. In some embodiments, the needle cap <NUM> can be pushed off of the needle <NUM> by moving the sleeve <NUM>, 20a distally. In some embodiments, the needle cap <NUM> may be configured to split when the needle cap <NUM> contacts the distal endcap <NUM>, 14a, 14b, 14c.

The needle cap <NUM> includes a cylindrical needle cap body <NUM> that defines a void <NUM> that is configured to fit over the needle <NUM>. The needle cap <NUM> also includes an atraumatic tip <NUM> that is integrally molded with or otherwise attached to the cylindrical needle cap body <NUM>. In some embodiments, the needle cap <NUM> includes one or more elongate slots <NUM> that extend axially along the cylindrical needle cap body <NUM> and provide sufficient flexibility to allow the needle cap <NUM> to flex enough to be advanced onto the needle <NUM>. In some embodiments, there may be two slots <NUM>, although only one is visible in <FIG> and <FIG>. The needle cap <NUM> includes one or more convex protuberances <NUM> that are configured to fit into the distal detent <NUM> of the needle <NUM>. While the cylindrical needle cap body <NUM> is shown as having parallel sides, in some cases the needle cap <NUM> may have flared sides that can compress for delivery. Extending the needle <NUM> distally can allow the flared sides of the needle cap <NUM> to expand. The needle can then be withdrawn proximally to push the needle cap <NUM> off of the needle <NUM>.

<FIG> illustrate another way of protecting the needle <NUM>, either from damaging the interior of an endoscope or from becoming damaged itself. <FIG> are various views of a suture translation assembly <NUM> that provides a reduced overall length that facilitates loading into an endoscope. In some instances, the suture translation assembly <NUM> is short enough to permit easy passage through an endoscope with the sleeve in place over the needle. In some embodiments, control of the suture translation assembly <NUM> is reversed relative to the suture translation assemblies <NUM>, 12a, 12b described with respect to previous Figures. <FIG> shows the suture translation assembly <NUM> in an unlocked position, in which the needle <NUM> is unlocked relative to the distal shuttle and can be passed to the distal endcap <NUM>, 14a, 14b, 14c. <FIG> shows the suture translation assembly <NUM> in a locked position, in which the needle <NUM> is locked to the distal shuttle. As seen, the suture translation assembly <NUM> includes a sleeve <NUM> and a suture catheter <NUM>. In some embodiments, as illustrated, the suture catheter <NUM> is a coil. The sleeve <NUM> has a pair of slots <NUM> (only one slot <NUM> is visible in the illustrated orientation) in order to accommodate movement of a distal shuttle, as will be discussed. The sleeve <NUM> also includes a pair of sleeve openings <NUM> (only one visible) that permit bearing balls <NUM> (not shown) to move in and out relative to a distal shuttle, thereby locking and unlocking the needle <NUM>.

The internal structure of the suture translation assembly <NUM> is better seen in <FIG>, which is a cross-sectional view taken along the line <NUM>-<NUM> of <FIG>, as well as <FIG>, which is a partially exploded view of <FIG>. As can be seen, a control wire <NUM> extends through the suture catheter <NUM> and terminates within a yoke <NUM>. The sleeve <NUM> is coupled to the suture catheter <NUM> via a coupler <NUM>. In some embodiments, the sleeve <NUM> may be welded to the suture catheter <NUM>, either directly or by being welded to the coupler <NUM>. As a result, the sleeve <NUM> does not move relative to the suture catheter <NUM>.

A pin <NUM> extends through the yoke <NUM> and into apertures <NUM> that are formed within a distal shuttle <NUM>, thereby operably coupling the control wire <NUM> to the distal shuttle <NUM>. The pin <NUM> extends to and is guided by a pair of slots <NUM> that are formed in the sleeve <NUM>. This prevents rotation of the distal shuttle <NUM> relative to the sleeve <NUM>. In some embodiments, the distal shuttle <NUM> includes a groove <NUM> that allows a suture to extend from the needle <NUM> and extend axially through the sleeve <NUM>.

The distal shuttle <NUM> also includes a pair of bearing ball openings <NUM>. As discussed previously, when the bearing ball openings <NUM> are aligned with the sleeve openings <NUM>, the bearing balls <NUM> (not shown) are free to move radially outwardly sufficiently to clear the proximal detent <NUM> of the needle <NUM>, thereby unlocking the needle <NUM> from the distal shuttle <NUM>. Conversely, when the bearing ball openings <NUM> are misaligned with the sleeve openings <NUM>, the bearing balls <NUM> (not shown) are not able to clear the proximal detent <NUM> of the needle <NUM>, and the needle <NUM> remains locked to the distal shuttle <NUM>. Accordingly, moving the control wire <NUM> in a proximal direction moves the distal shuttle <NUM> in a proximal direction relative to the sleeve <NUM>. This causes the sleeve openings <NUM> to misalign with the bearing ball openings <NUM> and locks the needle <NUM> to the sleeve <NUM>. Conversely, moving the control wire <NUM> in a distal direction moves the distal shuttle <NUM> in a distal direction relative to the sleeve <NUM>.

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 device (<NUM>) for use in combination with an endoscope having a working channel and a distal end, the suture device comprising:
a suture translation assembly (<NUM>) configured to be axially translatable within the working channel of the endoscope, the suture translation assembly including:
a needle (<NUM>) configured to carry a suture, the needle including a distal end and a distal detent near the distal end;
a distal shuttle (<NUM>) configured to releasably secure the needle; and
a sleeve (<NUM>) disposable over the distal shuttle, the sleeve 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 assembly (<NUM>) configured to be secured to the distal end of the endoscope and comprising a distal endcap (<NUM>), wherein the suture translation assembly extends into the distal assembly;
characterised by the suture device further comprising a needle cap (<NUM>) configured to releasably fit over the distal end of the needle, wherein the needle cap is configured to be pushed off the needle inside the patient.