Single actuating jaw flexible endolumenal stitching device

An end effector for use in an endoscopic stitching device includes a fixed jaw, a moveable jaw, a linkage member, needle engaging blades and a rotatable member. The moveable jaw is pivotably associated with the fixed jaw about a first pivot axis. The linkage member is pivotably associated with the moveable jaw about a second pivot axis. The needle engaging blade is slidably supported in each of the fixed and moveable jaws. An axial movement of the linkage member causes the moveable jaw to pivot about the first pivot axis with respect to the fixed jaw, and rotation of the rotatable member causes opposed axial movement of the pair of needle engaging blades.

BACKGROUND

1. Technical Field

The present disclosure relates to a device for endoscopic suturing or stitching, and, more particularly, to an end effector for endoscopic suturing or stitching through an access tube.

2. Background of Related Art

Generally, endoscopic surgery involves incising through body walls for viewing and/or operating on a particular organ, such as, for example, the ovaries, uterus, gall bladder, bowels, kidneys, and appendix. Typically, trocars are utilized for creating an incision through which the endoscopic surgery is performed. Trocar tubes or cannula devices are extended into and left in place in the abdominal wall to provide access for endoscopic surgical tools. A camera or endoscope is inserted through a relatively large diameter trocar tube, which is generally located at the naval incision, and permits the visual inspection and magnification of the body cavity. The surgeon can then perform diagnostic and therapeutic procedures at the surgical site with the aid of specialized instrumentation, such as, forceps, cutters, applicators, and the like which are designed to fit through additional cannulas.

In many surgical procedures, including those involved in endoscopic surgery, it is often necessary to suture bodily organs or tissue. In the past, suturing of bodily organs or tissue through endoscopic surgery was achieved through the use of a sharp metal suture needle which had attached at one of its ends a length of suture material. The surgeon would cause the suture needle to penetrate and pass through bodily tissue, pulling the suture material through the bodily tissue. Once the suture material was pulled through the bodily tissue, the surgeon proceeded to tie a knot in the suture material. The knotting of the suture material allowed the surgeon to adjust the tension on the suture material to accommodate the particular tissue being sutured and control approximation, occlusion, attachment or other conditions of the tissue. The ability to control tension is extremely important to the surgeon regardless of the type of surgical procedure being performed. However, during endoscopic surgery, knotting of the suture material is time consuming and burdensome due to the difficult maneuvers and manipulation which are required through the small endoscopic openings.

Accordingly, a need exists for improved surgical stitching devices for conducting endoluminal stitching and the like.

SUMMARY

In accordance with the present disclosure, an end effector of an endoscopic stitching device includes a fixed jaw, a moveable jaw, a coupler, a linkage member, needle engaging blades and a rotatable member. The moveable jaw is pivotably associated with the fixed jaw and is pivotable about a first pivot axis. Each jaw defines a needle receiving recess formed in a tissue contacting surface thereof and a longitudinal channel in communication with the needle receiving recess. The linkage member is pivotably associated with the moveable jaw about a second pivot axis. Each needle engaging blade is slidably supported in each of the fixed jaw and the moveable jaw. Each blade is axially translatable in the longitudinal channel between a first position in which the blade partially extends across the needle receiving recess and a second position in which the blade does not extend across the needle receiving recess. The rotatable member defines a helical groove in an outer surface thereof. A proximal end of each blade is configured for slidable engagement in the helical groove, wherein the blades are disposed on opposed sides of the rotatable member. An axial movement of the coupler causes the curvilinear movement of the linkage member resulting in the moveable jaw to pivot about the first pivot axis with respect to the fixed jaw, and rotation of the rotatable member causes opposite axial movement of the pair of needle engaging blades with respect to each other.

In an embodiment, the end effector may further include a lead screw operatively coupled to the coupler, wherein rotation of the lead screw causes axial movement of the coupler.

In addition, the coupler may be pivotally connected to the linkage member such that rotation of lead screw, relative to the coupler, axially displaces coupler and pivots the moveable jaw about the first pivot axis.

The end effector may further include a jaw support member defining a longitudinal axis, wherein the fixed jaw is securely fixed to the jaw support member. The jaw support member may define a lumen configured to rotatably support the rotatable member therein and a pair of grooves configured to slidably receive respective needle engaging blades.

The first pivot axis may be disposed on the longitudinal axis defined by the jaw support member. The second pivot axis may be offset from the longitudinal axis defined by the jaw support member. It is also contemplated that the moveable jaw may define a second longitudinal axis and that the first pivot axis be spaced a first transverse distance from a second longitudinal axis. The second pivot axis may be spaced a second transverse distance from the second longitudinal axis. The second transverse distance may be greater than the first transverse distance. The first pivot axis and the second pivot axis may be parallel to one another.

In another embodiment, the lead screw may include an annular flange projecting radially outward for rotatable engagement with the jaw support member. The jaw support member may define an inner circumferential groove for receiving the annular flange of the lead screw therein. The end effector may further include an actuation cable coupled to the linkage member. The actuation cable may be slidably movable through a longitudinal bore defined in the rotatable member. Uni-directional rotation of the rotatable member results in axial translation of the pair of needle engaging blades in opposite directions with respect to each other.

In accordance with still another embodiment of the present disclosure, an end effector for use in an endoscopic stitching device includes a fixed jaw, a moveable jaw, a coupler, a linkage member, needle engaging blades, a hub, a pair of opposing cuffs, and a pair of wires. The moveable jaw is pivotably associated with the fixed jaw and is pivotable about a first pivot axis. Each jaw defines a needle receiving recess formed in a tissue contacting surface thereof and a longitudinal channel in communication with the needle receiving recess. The linkage member is pivotably associated with the moveable jaw about a second pivot axis. Each needle engaging blade is slidably supported in each of the fixed jaw and the moveable jaw. Each blade is axially translatable in the longitudinal channel between a first position in which the blade partially extends across the needle receiving recess and a second position in which the blade does not extend across the needle receiving blade. The hub defines a central lumen therethrough. Each cuff partially surrounds the hub and is configured for axial translation. The pair of wires operatively actuates the needle engaging blades. Each cuff is coupled to one of the pair of needle engaging blades and a respective one of the pair of wires. An axial movement of the pair of wires causes axial movement of the pair of needle engaging blades and an axial movement of the linkage member causes the moveable jaw to pivot about the first pivot axis with respect to the fixed jaw.

In still another embodiment, the pair of opposing cuffs may be configured for independent axial translation with respect to each other. The pair of needle engaging blades may be coaxially arranged with respect to respective wire of the pair of wires.

In yet another embodiment, the end effector may further include a lead screw operatively coupled to the coupler, wherein rotation of the lead screw causes axial movement of the coupler. The end effector may further include an actuation cable, wherein the actuation cable is coupled with the lead screw for concomitant rotation therewith. The actuation cable may be slidably disposed within the central lumen of the hub.

It is contemplated that the end effector may further include a jaw support member defining a longitudinal axis, wherein the fixed jaw is securely fixed to the jaw support member. The first pivot axis may be disposed on the longitudinal axis defined by the jaw support member. The second pivot axis may be offset from the longitudinal axis defined by the jaw support member.

The moveable jaw may define a second longitudinal axis, and the first pivot axis may be spaced a first transverse distance from the second longitudinal axis and the second pivot axis may be spaced a second transverse distance from the second longitudinal axis. The second transverse distance may be greater than the first transverse distance. The first pivot axis and the second pivot axis may be parallel to one another.

The end effector may further include a lead screw operatively coupled with the coupler, wherein rotation of the lead screw, relative to the coupler, may cause axial movement of the coupler.

In accordance with still yet another embodiment of the present disclosure, an end effector for use in an endoscopic stitching device includes a fixed jaw, a moveable jaw, a coupler, a linkage member, needle engaging blades, a hub and first and second lead screws. The moveable jaw is pivotably associated with fixed jaw and is pivotable about a first pivot axis. Each jaw defines a needle receiving recess formed in a tissue contacting surface thereof and a longitudinal channel in communication with the needle receiving recess. The linkage member is pivotably associated with the moveable jaw about a second pivot axis. The needle engaging blade is slidably supported in each of the fixed jaw and the moveable jaw. Each blade is axially translatable in the longitudinal channel between a first position in which the blade partially extends across the needle receiving recess and a second position in which the blade does not extend across the needle receiving blade. The first and second lead screws are rotatably supported on the hub. The pair of needle engaging blades engages with respective first and second lead screws, wherein a rotation of the first and second lead screws causes axial translation of respective needle engaging blades, and an axial movement of the coupler causes a curvilinear movement of the linkage member causing the moveable jaw to pivot about the first pivot axis.

In an embodiment, the first and second lead screws may be configured to rotate independent of each other. The first and second lead screws may be configured to transmit independent axial translation to the pair of needle engaging blades.

DETAILED DESCRIPTION

Various embodiments of the presently disclosed device for endoscopic, laparoscopic, endoluminal, and/or transluminal suturing will now be described in detail with reference to the drawings, wherein like reference numerals identify similar or identical elements. In the drawings and in the description that follows, the term “proximal,” will refer to the end of a device or system that is closest to the operator, while the term “distal” will refer to the end of the device or system that is farthest from the operator.

An endoscopic suturing device generally includes a handle assembly or other suitable actuating mechanism, an elongate tubular body, a neck assembly, and an end effector. The handle assembly is connected to a proximal portion of the elongate tubular body and a neck assembly is operatively supported on a distal end of the elongate tubular body. The end effector is operatively supported at a distal end of the neck assembly, which allows the end effector to articulate in response to actuation of articulation cables. The end effector includes a suture needle and a pair of jaws. In operation, the suture needle is passed back and forth through tissue from one jaw to the other. Reference may be made to U.S. Patent Publication No. 2009/0312773, filed on Jun. 10, 2009, the entire content of which being incorporated herein by reference, for a detailed discussion of the construction and operation of an endoscopic suturing device.

Referring now toFIG. 1, an end effector of a stitching device in accordance with an embodiment of the present disclosure is shown generally as100. End effector100is adapted to be particularly useful in endoscopic or laparoscopic procedures as end effector100is insertable into a surgical site, via a cannula assembly or the like. End effector100extends from a distal end of an elongate tubular body (not shown) extending distally from a handle assembly and defining longitudinal axis and a lumen therethrough. End effector100may be remotely operable by the handle assembly or other suitable actuating mechanism.

With reference toFIGS. 1 and 2, end effector100includes a neck assembly110and a tool assembly120supported on a distal end of neck assembly110. Neck assembly110includes a plurality of joints112. Each joint112includes a distal knuckle112aand a proximal clevis112b. Each knuckle112aoperatively engages a clevis112bof an adjacent joint112. Each joint112defines a central lumen112cand a pair of opposed lumen112d,112edefined on either side of central lumen112c. A pair of articulation cables114a,114bslidably extends through respective lumens112d,112eof joints112. Distal ends of articulation cables114a,114bare anchored to a distal-most joint112at a location offset from a central axis thereof.

With reference now toFIGS. 2-5, tool assembly120includes a jaw assembly130. Jaw assembly130includes a jaw support member122defining a lumen124, a pair of jaws131,132, an actuation coupler135and a linkage member137. Lumen124of jaw support member122is configured and dimensioned to receive a stem112fextending from a distal-most joint112of neck portion110.

With reference toFIGS. 3-6, each jaw131,132of jaw assembly130includes respective base portions131c,132cand respective arm portions131e,132eextending distally from respective base portions131c,132c. Each jaw131,132includes a needle receiving recess131a,132a(as best shown inFIG. 6) configured to surround and hold at least a portion of a surgical needle104disposed substantially perpendicular to tissue engaging surfaces thereof. Needle104includes groove104a,104bformed near each end thereof (as shown inFIG. 2). A suture “S” may be secured to needle104at a location between grooves104a,104b. Suture “S” of needle104may include a one-way or barbed suture having an elongate body with a plurality of barbs extending therefrom. The barbs may be oriented in such a way that the barbs cause the suture to resist movement in a direction opposite relative to the direction in which the barb faces.

As seen inFIGS. 2,4and5, base portion131cof moveable jaw131extends in a direction transverse to a longitudinal axis of arm portion131e. Base portion131cof moveable jaw131defines a first pivot axis “P1” spaced a first transverse distance from the longitudinal axis of arm portion131e, and a second pivot axis “P2” spaced a second transverse distance from the longitudinal axis of arm portion131e. The second transverse distance to second pivot axis “P2,” relative to the longitudinal axis of arm portion131e, is greater than the first transverse distance to first pivot axis “P1.” Additionally, first pivot axis “P1” and second pivot axis “P2” are parallel to one another.

With continued reference toFIGS. 2-6, base portion132cof fixed jaw132is securely fixed to a distal portion of jaw support member122, and base portion131cof moveable jaw131is pivotably connected to base portion132cof fixed jaw132by a pin133extending through first pivot axis “P1” (seeFIGS. 1 and 5). First axis “P1” is disposed on a center axis “X-X” (seeFIGS. 1 and 5) defined by jaw support member122. Actuation coupler135is coupled to moveable jaw131by linkage member137. A first end137aof linkage member137is pivotably connected to base portion131cof moveable jaw131at a second pivot axis “P2” which is offset a radial distance from center axis “X-X.” In particular, first end137aof linkage member137may include at least one protrusion member137cpivotably received in at least one hole131fdefined in base portion131cof moveable jaw131through second pivot axis “P2.” A second end137bof linkage member137may include a peg member137dconfigured to engage a bore135adefined at a distal end portion of actuation coupler135. In this manner, axial movement of actuation coupler135(as will be discussed below) pivots moveable jaw131about first pivot axis “P1,” relative to fixed jaw132, thereby enabling opening and closing of the pair of jaws131,132. It is envisioned that the placement of second pivot axis “P2,” spaced the second transverse distance from the longitudinal axis of arm portion131e, may be tailored to provide the optimal mechanical advantage for jaw closure based on the needs of a particular procedure being performed. Furthermore, it is also contemplated that any number of bar-linkages may be used to actuate opening and closing of the pair of jaws131,132.

With reference now toFIGS. 2 and 8, tool assembly120further includes a stitch actuation assembly160. Stitch actuation assembly160includes a camming hub144configured for rotatable disposition within lumen124of jaw support member122, a keyed rod140and an actuation cable142. Keyed rod140includes a distal end140arotatably connected to actuation coupler135, a proximal end140bfixedly connected to a distal end of an actuation cable142and a body portion140chaving a non-circular cross-sectional profile. Camming hub144defines a lumen144atherethrough configured and adapted to slidably receive body portion140cof keyed rod140therein. Camming hub144defines a helical or spiral groove144bin an outer surface thereof. Helical groove144bmay define various angles with respect to center axis “X-X” of jaw support member.

Camming hub144is configured for rotatable disposition within lumen124of jaw support member122. Rotation of actuation cable142imparts concomitant rotation to keyed rod140, which in turn imparts rotation to camming hub144. However, since keyed rod140is rotatably connected to actuation coupler135, no rotation is imparted to actuation coupler135. Axial displacement of actuation cable142imparts axial displacement to keyed rod140which in turn imparts axial displacement to actuation coupler135of jaw assembly130. However, since camming hub144is axially slidably supported on keyed rod140, no axial displacement is imparted to camming hub144.

With particular reference now toFIGS. 2 and 6, tool assembly120further includes a pair of needle engaging blades150,152. Blades150,152are slidably supported within respective channels (not shown) defined in jaw support member122and are extended into blade receiving channels131d,132dof respective jaws131,132. Channels131d,132dare dimensioned and configured to at least partially intersect needle receiving recesses131a,132a. Thus, by advancing blade150or152within respective channel131d,132d, a distal end150a,152aof blade150,152engages or “locks in” groove104a,104bdefined in needle104disposed within the respective recess131a,132a. Proximal ends150b,152bof respective blades150,152are slidably disposed within groove144bof camming hub144. In particular, proximal ends150b,152bof respective blades150,152may be radially opposing each other in groove144b. In this manner, as camming hub144is rotated, proximal ends150b,152bof blades150,152ride within groove144bof camming hub144and are moved axially in opposite directions relative to each other. In particular, upon rotation of camming hub144, blade150may move distally, while blade152moves proximally or vice versa. Groove144bdefined in camming hub144may be varied to accommodate various degrees of rotation of camming hub144for axial movement of respective blades150,152. For example, a 180-degree rotation of camming hub144or actuation cable142causes axial movement of blades150,152from a proximal-most position to a distal-most position or vice versa in respective blade receiving channels131d,132d. However, as shown inFIG. 9, groove544bdefined in camming hub544may achieve axial movement of each blade150,152from the proximal-most position to the distal-most position or vice versa, in respective blade receiving channels131d,132d, by a 360-degree rotation of camming hub544.

With continued reference toFIGS. 1-6, a method of operating end effector100is now described. First, the pair of jaws131,132is placed in an open position by having actuation coupler135at a distal-most position, such that actuation coupler135pushes linkage member137distally and pivots moveable jaw131about first pivot axis “P1” to an open position. At this time, it is assumed that needle104is held within needle receiving recess131aby distal end150aof blade150engaging groove104aof needle104. In order to approximate jaws131,132, actuation cable142is moved in a proximal direction, which proximally moves key rod140in camming hub144. Actuation coupler135, rotatably coupled to key rod140, also moves proximally, thus pulling linkage member137proximally and causing moveable jaw131to pivot about first pivot axis “P1” and move the pair of jaws131,132into a closed position. As the pair of jaws131,132is moved to the closed position, a free end of needle104is moved into recess132aof fixed jaw132. If tissue were present between the pair of jaws131,132, the free end of needle104would penetrate through the tissue prior to the entrance into recess132aof fixed jaw132.

Needle104may then be released from moveable jaw131and secured or locked in fixed jaw132, by rotating actuation cable142, which in turn imparts rotation to keyed rod140, which further imparts rotation to camming hub144. As camming hub144is rotated proximal ends150b,152bof blades150,152ride along or through groove144b. As camming hub144is rotated blade150is moved in a proximal direction while blade152is moved in a distal direction. Distal end150aof blade150disengages groove104aof needle104disposed within recess131aof moveable jaw131, and distal end152bof blade152engages groove104aof needle104disposed within recess132aof fixed jaw132. Needle104is now secured or locked within recess132aof fixed jaw132.

Additionally, end effector100may be articulated about neck assembly110, by withdrawing one of articulation cables114a,114bin a proximal direction. As one of the articulation cables114a,114bis drawn in a proximal direction, a distal end thereof, anchored to the distal-most joint112rotates about the interface between knuckles112aand clevis112bcausing gaps defined therebetween, along a side surface thereof, to constrict. In order to return end effector100to an unarticulated condition or to articulate end effector100in an opposite direction the other of articulation cables114a,114bis withdrawn in a proximal direction.

Turning now toFIG. 7, a tool assembly according to another embodiment of the present disclosure is generally designated as tool assembly220. Tool assembly220is substantially similar to tool assembly120, and thus will only be described in detail herein to the extent necessary to identify differences in construction and operation thereof. Throughout the following disclosure, like reference numerals will be used to identify like elements.

Tool assembly220may be supported on a distal end of neck assembly110. Tool assembly220includes a jaw assembly230having a jaw support member222defining a lumen224therethrough, a pair of jaws231,232, an actuation coupler235, a lead screw270, and a linkage member237.

The pair of jaws231,232each include respective needle receiving recesses231a,232aconfigured to surround and hold at least a portion of surgical needle104disposed substantially perpendicular to tissue engaging surfaces thereof. A base portion232cof fixed jaw232is securely fixed to a distal portion of jaw support member222, and base portion231cof moveable jaw231is pivotably connected to base portion232cof fixed jaw232about a first pivot axis “P1.” First pivot axis “P1” is disposed on center axis “Y-Y” defined by jaw support member222. Actuation coupler235is coupled to jaw231by linkage member237, such that axial movement of actuation coupler235pivots moveable jaw231about first pivot axis “P1” relative to fixed jaw232, thereby enabling opening and closing of the pair of jaws231,232.

Lead screw270is supported in jaw support member222by a lead screw support274. Lead screw support274defines an inner circumferential groove278. Lead screw270includes an annular flange276projecting radially outward near a proximal portion270athereof for rotatable engagement with inner circumferential groove278of lead screw support274. In this manner, the axial location of lead screw270is fixed with respect to support member222. Lead screw270further includes threads at a distal portion270bthereof for engagement with a longitudinally threaded bore235aof actuation coupler235. Proximal portion270aof lead screw270is connected with actuation cable142for concomitant rotation therewith. Rotation of actuation cable142in the direction of arrow “A,” for example, as shown inFIG. 7, causes concomitant rotation of lead screw270which in turn axially moves actuation coupler235along longitudinal axis “Y-Y.” Distal axial movement of actuation coupler235pushes linkage member237distally causing moveable jaw231to pivot about first pivot axis “P1” in the direction of arrow “B,” thereby opening the pair of jaws231,232. A method of operating tool assembly220is substantially similar to that of tool assembly120described above, and thus will not be discussed in further detail herein in the interest of brevity.

In accordance with another aspect of the present disclosure, a stitch actuation assembly660, as shown inFIG. 10, includes a pair of needle engaging blades650,652, a hub644, first and second sleeves643,645, and first and second wires677,679. Hub644includes a bore (not shown) through which actuation cable642passes. Sleeves643,645include opposing cuffs or partial ring portions643a,645a, respectively. Each opposing partial ring portion643a,645aat least partially circumferentially surrounds hub644and are each axially translatable independent with respect to each other. Sleeves643,645further include guide members643b,645b, respectively. Guide members643b,645bextend proximally from respective ring portions643a,645aand facilitate sliding of sleeves643,645on the outer surface of hub644. The pair of needle engaging blades650,652are coupled to respective ring portions643a,645aof first and second sleeves643,645. Stitch actuation assembly660includes first and second wires677,679connected to respective guide members643b,645b. Wires677,679may be arranged in a coaxial fashion with blades652,650, respectively. Actuation cable642may be coupled to a lead screw670, which may operatively engage actuation coupler235in a manner similar to the way lead screw270of tool assembly220engages actuation coupler235, as seen inFIG. 7.

In operation, each wire677,679may be pulled or pushed to independently actuate respective blades650,652. However, it is also envisioned that pulling or pushing of only one of wires677,679may actuate the blade of the other wire by using a combination of a rack and pinion, a pivoting yoke, etc.

In accordance with yet another aspect of the present disclosure, a stitch actuation assembly760, as shown inFIG. 11, includes a pair of needle engaging blades750,752, a support hub744, and first and second lead screws743,745rotatably connected to support hub744. In this manner, the axial locations of first and second lead screws743,745are fixed with respect to support hub744and rotation of each lead screw743,745is not imparted to support hub744. The pair of needle engaging blades750,752includes first and second threaded members or nuts777,779, respectively. First and second threaded members777,779are in operative engagement with first and second lead screws743,745, respectively.

In operation, each of first and second lead screws743,745may be rotated independently to actuate respective blades750,752in blade receiving channels131d,132dof respective jaws131,132. However, it is also envisioned that rotation of one of lead screws743,745may also actuate the blade engaging the other lead screw by using a combination of a rack and pinion, a pivoting yoke, etc.

The surgical end effectors described above includes advantages of improved tissue approximation and more mechanical advantage during jaw closure. In addition, the lead screw jaw and blade actuation allows for a more flexible elongate tube, and thereby making the device more advantageous for endoluminal procedures.

It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely exemplifications of embodiments. Those skilled in the art will envision other modification within the scope and spirit of the claims appended thereto.