Suturing assembly and method

A suturing assembly including a first puncture element including a sharp distal end for puncturing tissue, a second puncture element including a sharp distal end for puncturing tissue, the distal ends of the first and second puncture elements being spaced from each other by a gap, suture thread disposed along a portion of the first puncture element, wherein the suture thread is arranged to be grabbed at the distal end of the first puncture element, and a suture grabber positioned at the distal end of the second puncture element.

FIELD OF THE INVENTION

The present invention relates generally to suturing devices and methods, such as for the percutaneous closure of body lumens and tissues by means of sutures.

BACKGROUND OF THE INVENTION

Many suturing devices are known in the art that puncture the skin with needles and percutaneously deliver sutures to the site. For example, U.S. Pat. No. 5,527,322 describes a suture applying device that includes a shaft having a nose piece attached at its distal end. The shaft and the nose piece are separated by a transition region, and a needle entry lumen in the shaft permits a flexible needle to be introduced in the distal direction. The needle is able to cross the transition region and penetrate tissue held therein and enter into a return lumen in the nose piece. The return lumen is U-shaped and acts to bend the flexible needle as it is advanced. In this way, the needle passes from the nose piece through the transition region in a proximal direction, and is able to pass through tissue within the transition region generally on the opposite side of a tissue puncture from the first suture passage. The needle then exits from the device, permitting the suture attached to the needle to be drawn fully through the device. The suture may then be tied in order to close and seal the tissue penetration.

SUMMARY OF THE INVENTION

The present invention seeks to provide an improved suturing assembly and methods, as described in more detail further below.

The assembly and methods of the present invention can be used to close a tissue puncture site with suture thread, such as a puncture site through the wall of a body lumen, or a percutaneous vascular puncture site at the distal end of a tissue tract. The assembly and methods can achieve closure wholly within the tissue tract leading to a puncture site and can be manipulated entirely from the portion of the device lying outside of the tissue tract. The present invention may be used in various medical procedures, such as but not limited to, laparoscopic procedures, endoscopic procedures, arthroscopic procedures, and the like.

There is thus provided in accordance with an embodiment of the present invention a suturing assembly including a first puncture element including a sharp distal end for puncturing tissue, a second puncture element including a sharp distal end for puncturing tissue, the distal ends of the first and second puncture elements being spaced from each other by a gap, suture thread disposed along a portion of the first puncture element, wherein the suture thread is arranged to be grabbed at the distal end of the first puncture element, and a suture grabber positioned at the distal end of the second puncture element, the suture assembly having a mode of operation wherein (a) the first puncture element punctures through a tissue wall so that the suture thread passes from a near side of the tissue wall to a far side of the tissue wall, (b) the second puncture element punctures through the tissue wall from the near side to the far side of the tissue wall, and (c) the suture grabber grabs the suture thread at the distal end of the first puncture element at the far side of the tissue wall, brings the suture thread across the gap and moves the suture thread proximally away from the distal end of the second puncture element back through to the near side of the tissue wall.

In accordance with an embodiment of the present invention the suture thread passes through a hollow portion of the first puncture element, and the suture grabber passes through a hollow portion of the second puncture element.

Further in accordance with an embodiment of the present invention the suture grabber is mounted on a cannula arranged to be moved through the second puncture element, such that as long as the cannula is inside the second puncture element, the suture grabber does not protrude out of the second puncture element, and when the slender cannula is moved distally out of the second puncture element, the suture grabber protrudes out of the second puncture element towards the suture thread at the distal end of the first puncture element.

In one exemplary embodiment, the suture grabber is biased by a biasing device, such that when the cannula is moved distally out of the second puncture element, the biasing device urges the suture grabber to protrude out of the second puncture element. In another exemplary embodiment, the suture grabber includes a resilient body, such that when the slender cannula is moved distally out of the second puncture element, spring energy of the resilient body urges the suture grabber to protrude out of the second puncture element.

The suture grabber may include a hook for grabbing the suture thread. A pull wire may be attached to the suture grabber for urging the suture grabber away from the distal end of the second puncture element.

There is also provided in accordance with an embodiment of the present invention a method for suturing including providing a first puncture element including a sharp distal end for puncturing tissue, providing a second puncture element including a sharp distal end for puncturing tissue, the distal ends of the first and second puncture elements being spaced from each other by a gap, providing suture thread disposed along a portion of the first puncture element, wherein the suture thread is arranged to be grabbed at the distal end of the first puncture element, providing a suture grabber positioned at the distal end of the second puncture element, puncturing through a tissue wall with the first puncture element so that the suture thread passes from a near side of the tissue wall to a far side of the tissue wall, puncturing through the tissue wall with the second puncture element from the near side of the tissue wall to the far side of the tissue wall, and grabbing the suture thread with the suture grabber at the distal end of the first puncture element at the far side of the tissue wall, bringing the suture thread across the gap and moving the suture thread proximally away from the distal end of the second puncture element back through to the near side of the tissue wall. Afterwards, the suture thread may be secured to form a stitch.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made toFIG. 1is a simplified pictorial illustration of a suturing assembly10, constructed and operative in accordance with a non-limiting embodiment of the present invention.

Suturing assembly10includes a first puncture element12including a sharp distal end14for puncturing tissue, and a second puncture element16including a sharp distal end18for puncturing tissue. The distal ends14and18of first and second puncture elements12and14are spaced from each other by a gap20. Preferably, but not necessarily, first and second puncture elements12and14are parallel to each other.

First and second puncture elements12and16are hollow. A suture manipulating assembly22that includes a suture thread receiving member24and a suture grabber26, which can be passed into the hollow portions of first and second puncture elements12and16, respectively. First and second puncture elements12and16are provided with distal funnel cups28and30, respectively, for guiding insertion of suture thread receiving member24and suture grabber26. The funnel cups28and30also serve as stops to limit movement of suture thread receiving member24and suture grabber26into first and second puncture elements12and16. Proximal ends of suture thread receiving member24and suture grabber26are mounted on a handle assembly32, described more in detail hereinbelow.

Reference is now made toFIG. 2, which is a more detailed illustration of suture thread receiving member24. In accordance with an embodiment of the present invention, a distal end of suture thread receiving member24includes two tines34separated from each other by a gap36. Suture thread38sits on crevices40formed at the end of tines34. Suture thread38may thus be doubled over suture thread receiving member24, either along a partial length thereof or the entire length thereof. Suture thread22is thus arranged to be grabbed at the distal end14of first puncture element12(FIG. 1), as is explained below.

Reference is now made toFIG. 3, which is a more detailed illustration of suture grabber26. In accordance with an embodiment of the present invention, suture grabber26is pivotally mounted about a pivot42at a distal end of a slender cannula44arranged to be moved through second puncture element16. Suture grabber26has a hook46for grabbing suture thread, as is described below. Suture grabber26is biased by a biasing device48, e.g., a coil spring attached to suture grabber26by means of a pull wire50(e.g., made of nylon). The proximal end of pull wire50may be held in tension by a another wire52(e.g., made of steel) fixed to a fastener block54.

Referring now toFIG. 5A, suture thread receiving member24is mounted on an adjustable block60of handle assembly32. Adjustable block60is arranged for moving with respect to a distal block62of handle assembly32by means of a latch64formed with a channel66in which is received a pin68mounted on distal block62. A guide pin or wire70from adjustable block60moving in a groove72of distal block62may guide the movement of adjustable block60with respect to distal block62.

In operation of suturing assembly10, first and second puncture elements12and16are first pushed into tissue and the sharp distal ends14and18puncture a tissue wall65(FIG. 4A). Of course, in the illustrated embodiment, the first and second puncture elements12and16puncture through tissue wall65basically at the same time, but it is possible to construct the assembly so they are not fixed together rigidly and so they puncture the tissue wall65one after the other.

The suture thread receiving member24and suture grabber26of suture manipulating assembly22are then introduced into the hollow portions of first and second puncture elements12and16, respectively. Initially, adjustable block60is in the position ofFIG. 5A. When suture thread receiving member24is pushed fully up to funnel cup28, suture thread38passes from a near side65A of tissue wall65to a far side65B of tissue wall65.

As long as cannula44is inside second puncture element16, suture grabber30is forced to lie flat with the distal end of cannula44and does not protrude out of second puncture element16. However, when suture grabber26is pushed fully up to funnel cup30, cannula44is moved distally out of second puncture element16. At this point, the proximally-directed spring force of biasing device48pulls suture grabber30about pivot42in the direction of an arrow56(FIGS. 3 and 4A). Suture grabber30swings out of second puncture element16towards the suture thread22at the distal end14of first puncture element12. This position is illustrated inFIG. 4A.

(As similarly mentioned above, in the illustrated embodiment, suture thread receiving member24and suture grabber26are fixed together rigidly and move together. However, they could be constructed and arranged so that suture grabber26is moved distally after distal movement of suture thread receiving member24.)

Referring now toFIGS. 5A and 5B, adjustable block60is moved proximally in the direction of an arrow74, geometrically locking pin68at the end of channel66of latch64. This moves suture thread receiving member24also in the direction of arrow74(FIG. 4) until suture thread38is caught and grabbed by suture grabber26, as seen inFIGS. 4B and 6.

The suture thread receiving member24and suture grabber26of suture manipulating assembly22are then pulled proximally (backwards). This movement pulls suture grabber26back into second puncture element16(suture grabber26pivots to being straight with cannula44). As suture grabber26moves proximally it brings along with it suture thread38over gap20, proximally away from the distal end18of second puncture element16, and back through to the near side65A of tissue wall65. Afterwards, the suture thread38may be secured to form a stitch.

It is noted that in another exemplary embodiment, the suture grabber may include a resilient body made of a flexible resilient material, such as but not limited to, NITINOL. In this manner, when cannula44is moved distally out of second puncture element16, the spring energy of the resilient body urges suture grabber30to protrude out of second puncture element16.

It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of the features described hereinabove as well as modifications and variations thereof which would occur to a person of skill in the art upon reading the foregoing description and which are not in the prior art.