Patent Description:
Endoscopic resection has been accepted as a first choice of the treatment for early stage GI carcinomas because of less invasiveness and lower cost. Endoscopic submucosal resection (ESD) allows for an en bloc resection and accurate histopathological diagnosis regardless of the size, an existence of severe fibrosis at submucosal layer, and location of a lesion. One of the benefits of ESD is lower recurrence rates compared to endoscopic mucosal resection. During some ESD's, jaw members of a tissue clip are engaged to tissue. After performing the dissection, the jaw members are disengaged from the tissue.

<CIT> discloses medical devices that lift and retract tissue during a dissection procedure to improve visualization of the target tissue and mitigate obstructions for dissection tools. In particular, such a device may transition from a constrained to an unconstrained bowed configuration to immobilize and retract the dissected portion of target tissue during a dissection procedure.

<CIT> discloses an endoscopic surgical instrument icluding a hemostatic clip which is deployed during endoscopic submucosal resection. The hemostatic clip has an elongated collar configured to be detachably coupled to a shaft of the surgical instrument, a pair of jaws received in the collar, and a magnet coupled to the jaws.

<CIT> discloses a tissue retraction system including a first anchor, a second anchor, and an elongate coupling member extending between the first anchor and the second anchor. The system also may include a holder for receiving the first anchor, the second anchor, and the elongate coupling element. The holder may include a proximal portion and a distal portion. The distal portion may have a smaller width than the proximal portion such that the distal portion exerts a force on a proximal end of the first anchor during deployment of the first anchor from the holder. The force may move the first anchor into an open configuration for receiving tissue.

In one aspect, the present disclosure provides a tissue clip including a proximal body portion, first and second jaw members coupled to the proximal body portion, and a resilient member. The jaw members are configured to move between an open configuration and a closed configuration to grasp tissue therebetween. The resilient member is coupled to the proximal body portion or one of the first or second jaw members. The resilient member includes a segment that is laterally spaced from the proximal body portion when the resilient member is in a deployed state. The resilient member includes a first end portion coupled to the proximal body portion and extending distally therefrom, and a second end portion extending from the segment.

In aspects, the resilient member may be transitionable between a stored state and the deployed state.

In aspects, the segment of the resilient member may assume a linear shape when the resilient member is in the stored state, and the segment of the resilient member may assume an arcuate shape when the resilient member is in the deployed state.

In aspects, the segment of the resilient member may bow outwardly from the proximal body portion when the resilient member is in the deployed state.

In aspects, the segment may curve proximally and laterally from the first end portion.

In aspects, the second end portion may curve toward the proximal body portion.

In aspects, the second end portion may be disposed proximally of the first end portion.

In aspects, the resilient member may be configured to assume a looped configuration when in the deployed state.

In aspects, the resilient member may include a wire having a predefined shape.

In aspects, the resilient member may have a first end portion rotationally coupled to the proximal body portion, and a second end portion. The resilient member may be rotatable between a first position, in which the second end portion is disposed on a first side of the proximal body portion, and at least one second position, in which the second end portion is disposed on a second side of the proximal body portion.

In aspects, the proximal body portion may define an annular recess having the first end portion of the resilient member slidably received therein.

In aspects, the resilient member may include a wire wrapped about the proximal body portion.

In aspects, the first jaw member may define a pair of holes therethrough, and the resilient member may be attached to the first jaw member via the pair of holes.

In aspects, the resilient member may include first and second wires defining a gap therebetween.

In aspects, the gap may be greater than a diameter of the proximal body portion.

Objects and features of the presently disclosed tissue clips will become apparent to those of ordinary skill in the art when descriptions of various embodiments thereof are read with reference to the accompanying drawings, of which:.

The present disclosure is generally directed to tissue clips including an elongate body, a pair of jaw members received in the elongate body and deployable therefrom, and a resilient member coupled to the jaw members or the elongate body. The resilient member is configured to assume a predefined, curved shape upon deployment of the tissue clip at a surgical site. During use, target tissue (e.g., a lesion) is grasped between the jaw members and the resilient member, in the deployed state, engages a gastric wall to separate the lesion from the gastric wall. With the resilient member maintaining the lesion in spaced relation from the gastric wall, the lesion may be dissected. In aspects, the resilient member may be swivelable about the elongate body to adjust a position thereof. These and other aspects of the present disclosure are described in greater detail below.

<FIG> illustrates a hand-held surgical instrument <NUM> for deploying a tissue clip <NUM> (<FIG>). The surgical instrument <NUM> generally includes a handle <NUM>, a shaft <NUM> extending distally from the handle <NUM>, and a tissue clip <NUM> detachably coupled to a distal end portion <NUM> of the shaft <NUM>. In some aspects, instead of the clip <NUM> being deployable from a hand-held instrument, the clip <NUM> may be deployed from a surgical robotic arm.

The surgical instrument <NUM> includes an actuation mechanism, such as, for example, a puller (not shown) axially movable within the shaft <NUM>. The puller may have a proximal end operably coupled to a trigger <NUM> of the handle <NUM>, such that an actuation of the trigger <NUM> proximally translates the puller. The puller may have a distal end detachably coupled to the tissue clip <NUM>, such that proximal translation of the puller moves the tissue clip <NUM> from an open configuration to a closed configuration, as will be described. It is contemplated that the surgical instrument <NUM> may include any suitable actuation mechanism for deploying the tissue clip <NUM>.

With reference to <FIG>, the tissue clip <NUM> has a proximal body portion <NUM>, such as, for example, a tubular body, first and second jaw members <NUM>, <NUM> received in the proximal body portion <NUM>, and a resilient member <NUM> coupled to the proximal body portion <NUM>. The proximal body portion <NUM> is configured to be detachably coupled to the distal end <NUM> of the shaft <NUM>. In aspects, the shaft <NUM> may have a release latch (not shown) coupled to the proximal body portion <NUM> and an actuation mechanism (e.g., a pull rod, not shown) for actuating the release latch to deploy the tissue clip <NUM> from the shaft <NUM>.

The first and second jaw members <NUM>, <NUM> are each coupled to the proximal body portion <NUM>. Each of the first and second jaw members <NUM>, <NUM> has a proximal end portion slidably received in a hollow interior of the proximal body portion <NUM>, and a distal end portion disposed distally of the proximal body portion <NUM>. The distal end portion of the jaw members <NUM>, <NUM> may define teeth for assisting in grasping tissue between the jaw members <NUM>, <NUM>. The jaw members <NUM>, <NUM> may be resiliently biased toward an open configuration by a biasing member (not shown). Alternately, the jaw members <NUM>, <NUM> may be devoid of a resilient bias. The jaw members <NUM>, <NUM> are axially movable relative to the proximal body portion <NUM> from a proximal position, in which the distal end portion of the jaw members <NUM>, <NUM> are approximated toward one another, and a distal position, in which the distal end portion of the jaw members <NUM>, <NUM> are spaced away from one another.

The resilient member <NUM> of the tissue clip <NUM> is fabricated from a shape memory material, such as, for example, copper-aluminium-nickel or nickel-titanium. In some aspects, the resilient member <NUM> may be fabricated from any suitable material configured to maintain a predefined shape. The resilient member <NUM> is fabricated from a wire that is folded over itself, with the folded end <NUM> formed into a loop to form a first end portion 108a of the resilient member <NUM>, and the loose ends <NUM> of the wire being crimped together to form a second end portion 108b of the resilient member <NUM>. The two folded portions of the wire may define a gap or aperture <NUM> therebetween. By spacing the two folded portions of the wire, an intermediate segment 108c of the resilient member <NUM> is more suitable for supporting tissue thereon. In some aspects, instead of fabricating the resilient member <NUM> from a folded wire, the resilient member <NUM> may be a thin, elongated sheet of resilient material. Other constructions of the resilient member <NUM> are also contemplated.

The first end portion 108a of the resilient member <NUM> is rotationally supported on the proximal body portion <NUM>. Specifically, the proximal body portion <NUM> defines an annular recess <NUM> having the first end portion 108a of the resilient member <NUM> slidably received therein. The first end portion 108a of the resilient member <NUM> is wrapped about the proximal body portion <NUM> and slidably received in the annular recess <NUM>. As such, with the first end portion 108a of the resilient member <NUM> slidably received in the annular recess <NUM>, the first end portion 108a is free to rotate about a longitudinal axis "X" defined by the proximal body portion <NUM> while being axially restrained to the proximal body portion <NUM>.

The resilient member <NUM> assumes a looped configuration when in the deployed state. In particular, the first end portion 108a of the resilient member <NUM> extends distally from the annular recess <NUM> of the proximal body portion <NUM> and has a generally upwardly curved configuration. In aspects, the tissue clip <NUM> may have a collar <NUM> that clips onto the proximal body portion <NUM> and over the first end portion 108a of the resilient member <NUM> to hold the first end portion 108a in close relation with the proximal body portion <NUM>. The intermediate segment 108c of the resilient member <NUM> extends from the first end portion 108a and curves laterally away from the longitudinal axis "X" of the proximal body portion <NUM> and in a generally proximal direction, such that in the deployed state, the intermediate segment 108c assumes an arcuate shape. The second end portion 108b of the resilient member <NUM> extends from the intermediate segment 108c and curves down toward the longitudinal axis "X" of the proximal body portion <NUM>.

In use, with the tissue clip <NUM> coupled to the shaft <NUM> and the jaw members <NUM>, <NUM> in the open configuration, the tissue clip <NUM> is positioned adjacent tissue (e.g., a lesion). The tissue is positioned between the jaw members <NUM>, <NUM>, whereupon the puller of the surgical instrument <NUM> retracts the jaw members <NUM>, <NUM> proximally through the proximal body portion <NUM>. An inner wall of the proximal body portion <NUM> acts on the jaw members <NUM>, <NUM> to move the jaw members <NUM>, <NUM> toward the closed configuration about the tissue. With the tissue grasped between the jaw members <NUM>, <NUM>, the puller is further retracted to detach the puller from the jaw members <NUM>, <NUM>, thereby releasing the proximal body portion <NUM> of the tissue clip <NUM> from the shaft <NUM> and leaving the tissue clip <NUM> at the surgical site. Other mechanisms for releasing the tissue clip <NUM> from the shaft <NUM> are also contemplated.

Upon releasing tissue clip <NUM> from the shaft <NUM>, the resilient member <NUM> of the tissue clip <NUM> is allowed to transition from a stored state, in which the resilient member <NUM> is constrained within the shaft <NUM>, to a deployed state. In the stored state, the resilient member <NUM> assumes a generally linear shape, and in the deployed state, the resilient member <NUM> moves toward its predefined, arcuate shape, in which the resilient member <NUM> bows outwardly from the proximal body portion <NUM>.

After, during, or prior to grasping the tissue with the jaw members <NUM>, <NUM>, the resilient member <NUM> is positioned between the tissue and a muscle layer of a gastric wall, whereby the outward resilient bias of the resilient member <NUM> separates the grasped tissue from the gastric wall. To change an orientation of the resilient member <NUM> to better position the resilient member <NUM> between the grasped tissue and the gastric wall, the first end portion 108a of the resilient member <NUM> may be rotated about the proximal body portion <NUM>. During rotation of the first end portion 108a, the intermediate segment 108c and the second end portion 108b is moved to a different side of the proximal body portion <NUM> until the desired orientation is achieved. With the tissue being maintained in spaced relation from the muscle layer by the resilient member <NUM>, the grasped tissue may be dissected from the muscle layer.

<FIG> illustrate another embodiment of a tissue clip <NUM> deployable from the surgical instrument <NUM>. The tissue clip <NUM> is similar to tissue clip <NUM> and will only be described in detail to elucidate differences between the two clips. The tissue clip <NUM> includes a proximal body portion, such as, for example, a tubular body <NUM>, first and second jaw member <NUM>, <NUM> received in the proximal body portion <NUM>, and a resilient member <NUM>. The proximal body portion <NUM> is configured to be detachably coupled to the distal end <NUM> of the shaft <NUM>. As shown in <FIG>, the surgical instrument <NUM> may have a sheath <NUM> detachably coupled to the shaft <NUM> and configured to encapsulate the resilient member <NUM> to selectively maintain the resilient member <NUM> in a stored, linear state. The tissue clip <NUM> differs from the tissue clip <NUM> by having the resilient member <NUM> directly attached to the jaw member <NUM>. In aspects, the resilient member <NUM> may be formed from a folded wire, or in some aspects two discreet wires, having the folded end <NUM> non-rotatably fixed to the jaw member <NUM>.

In aspects, the resilient member <NUM> consists of a single wire having two ends 208a, 208b that are attached to one another with a crimp <NUM>. The jaw member <NUM> has a pair of holes 214a, 214b extending through a thickness thereof. Each of the holes 214a, 214b are spaced from one another a selected distance extending along a width of the jaw member <NUM>. It is contemplated that the distance between the holes 214a, 214b in the jaw member <NUM> are selected so that two sections 209a, 209b of the single wire <NUM> are spaced from one another by a greater distance than the diameter of the tubular body <NUM> when deployed. In this way, upon the resilient member <NUM> engaging tissue, the resilient member <NUM> balances the tissue clip <NUM>, thereby preventing the tissue clip <NUM> from rotating out of engagement with the tissue.

During manufacturing and/or assembly of the tissue clip <NUM>, the two ends 208a, 208b of the single wire <NUM> are each respectively passed upwardly through the corresponding holes 214a, 214b in the jaw member <NUM> to establish a friction-fit engagement between the folded end <NUM> of the wire <NUM> and the jaw member <NUM>. After passing the single wire/resilient member <NUM> through the holes 214a, 214b of the jaw member <NUM>, the two ends 208a, 208b of the wire <NUM> are crimped together, thereby giving the resilient member <NUM> an enclosed loop shape. Attaching the resilient member <NUM> to the jaw member <NUM> via the holes 214a, 214b is a relatively cheap, easy, and effective means of coupling the resilient member <NUM> to the remainder of the tissue clip <NUM>.

With reference to <FIG>, another embodiment of a tissue clip <NUM> is illustrated. The tissue clip <NUM> is configured to be deployed from the surgical instrument <NUM> (<FIG>) and is similar to tissue clip <NUM>. The tissue clip <NUM> includes a pair of jaw members <NUM>, <NUM> and a resilient member or wire <NUM> (<FIG>) configured to be fixed to one of the jaw members <NUM>, <NUM>. Each of the jaw members <NUM>, <NUM> has a body member <NUM> having a generally semi-hemispherical shape along a length thereof and a distal tip <NUM> that curves inwardly toward the other. Each of the jaw members <NUM>, <NUM> has serrations <NUM> along the entire outer peripheral edge of the jaw members <NUM>, <NUM> to assist with grasping tissue. The body member <NUM> of at least one of the jaw members <NUM> has a cutout <NUM> that forms a tab <NUM> and a pair of holes 312a, 312b for receipt of the resilient member <NUM> (<FIG>).

During manufacturing and/or assembly of the surgical tissue clip <NUM>, the tab <NUM> is bent outwardly and the folded end <NUM> of the resilient wire <NUM> is passed over the tab <NUM> and inserted into the holes 312a, 312b. The tab <NUM> is then folded down to capture the folded end <NUM> of the resilient member <NUM> in the holes 312a, 312b. In this way, the opposing ends 208a, 208b (<FIG>) of the resilient member <NUM> may be crimped before attaching the resilient member <NUM> to the jaw member <NUM>.

Claim 1:
A tissue clip (<NUM>), comprising:
a proximal body portion (<NUM>);
first and second jaw members (<NUM>, <NUM>) coupled to the proximal body portion and configured to move between an open configuration and a closed configuration to grasp tissue therebetween; and
a resilient member (<NUM>) coupled to the proximal body portion, the resilient member including a segment (108c) that is laterally spaced from the proximal body portion when the resilient member is in a deployed state;
characterised in that the resilient member includes:
a first end portion (108a) coupled to the proximal body portion and extending distally therefrom, the segment curving proximally and laterally from the first end portion; and
a second end portion (108b) extending from the segment.