Patent Description:
In some settings, a surgeon may want to position a surgical instrument through an orifice formed in the body of the patient and use the instrument to adjust, position, attach, and/or otherwise interact with tissue within the patient. For instance, in some surgical procedures, portions of the gastrointestinal tract may be cut and removed to eliminate undesirable tissue or for other reasons. Once the desired tissue is removed, the remaining portions of the tissue may need to be recoupled together. One of such tools for accomplishing these anastomotic procedures is a circular stapler.

Due to the minimum invasive nature of the laparoscopic approach, laparoscopic surgery is deemed the best one for some patients. However, existing circular staplers are not a feasible option for modern minimal invasive laparoscopic surgery. In particular, they can only be used in laparoscopic assisted surgery and can't be used in total laparoscopic surgery since they are too big for typical <NUM> trocars required for laparoscopic surgery.

And, surgeons would prefer the possibility of end-to-end anastomosis in laparoscopic procedure because the tissues are healing better than side-to-end or side-to-side anastomosis. However, there is not an end-to-end anastomosis system available for total laparoscopic surgery today. Moreover, unreliable anastomosis leads to bleeding and leakage. Thus, surgeons still need to reinforce the anastomosis with suture after stapling to avoid of leakage.

With the foregoing in mind, it is desirable to provide a new stapler which is adapted for both total laparoscopic surgery and end-to-end anastomosis without the occurrence of leakage.

In <CIT>, there is described a surgical stapling device including a housing, an outer tube extending distally from the housing, a disposal staple assembly releasably supported on a distal end of the outer tube, an approximation assembly operably received within the housing, and a staple pusher assembly extending from within the housing to the distal end of the outer tube.

In <CIT>, there is described a full-thickness resection system comprising a flexible endoscope and a stapling mechanism, wherein the endoscope is slidably received through at least a portion of the stapling mechanism.

In <CIT>, there is described a surgical stapling apparatus which comprises a tissue stop configured to inhibit tissue from flowing out of the distal end of the stapling instrument as the tissue is being stapled and/or incised.

In <CIT>, there is described a one-piece surgical stapling apparatus that includes a stapler head and an anvil head assembly. The anvil head assembly is tiltable between a tilted position and a transverse position, and anvil plates of the anvil head assembly are moveable about one or more hinges between a closed and an open position. When in the tilted and closed positions, the anvil assembly has a reduced footprint that allows the anvil assembly to be passed directly through a trocar and holes created in the bodily tissues, which eliminates the need for separate placement of the anvil head. At the site of the anastomosis, the anvil head assembly can be moved to the transverse and open positions, and the stapling head may be engaged to fire staples against the anvil head.

It is, therefore, an object of the present invention to provide a laparoscopic stapler which can be used in total laparoscopic surgery. Also, a desired end-to-end anastomosis can be achieved by using such a stapler.

The present invention is thus defined by the independent claim.

<FIG> depicts an exemplary laparoscopic stapling instrument <NUM> having an anvil assembly <NUM>, a shaft assembly <NUM>, and an actuator handle assembly <NUM>. A separate staple housing assembly <NUM> is configured to be operatively coupleable to a closure system and a trigger system of the instrument. Staple housing assembly <NUM> is operable to drive staples toward anvil assembly <NUM> to form the staples when in a coupled position. Shaft assembly <NUM> extends distally from actuator handle assembly <NUM>, and anvil assembly <NUM> is coupled to a distal end of shaft assembly <NUM>. In one example, actuator handle assembly <NUM> is operable to actuate a push trigger of staple housing assembly <NUM> to drive a plurality of staples out of staple housing assembly <NUM> that is coupled at the distal end of the instrument. Staples are bent to form completed staples by anvil assembly <NUM>. Accordingly, tissue between the coupled and closed staple housing assembly <NUM> and anvil assembly <NUM> may be stapled utilizing instrument <NUM>.

As shown in <FIG>, staple housing assembly <NUM> is a separate flippable T shaped assembly. In one example, staple housing assembly <NUM> comprises a staple housing <NUM> and a housing shaft <NUM> extending proximally from staple housing <NUM>. Unlike usual circular stapling heads, staple housing <NUM> according to the present invention has an oblong or long circular shape, such as a shape of rounded rectangle or ellipse. Staple housing <NUM> is linked to housing shaft <NUM> via a head pivot <NUM>, for example, and housing shaft <NUM> is to selectively couple staple housing assembly <NUM> to the closure system of the instrument. In the embodiment, staple housing assembly <NUM> is rotatable about a longitudinal axis of the head pivot <NUM> between a first, linear configuration for delivery and a second, perpendicular configuration as shown for coupling and stapling. It is understood when in the linear configuration, staple housing assembly <NUM> has a quite low-profile which allows the entire assembly to go through a <NUM> trocar typically used in laparoscopic surgery, and when in the perpendicular configuration, staple housing <NUM> is pivotal to be perpendicular to housing shaft <NUM> to exhibit a high-profile. While staple housing assembly <NUM> is described as selectively coupleable to the closure system in this context, proximal shaft may include a one-way coupling feature such that staple housing assembly <NUM> cannot be removed from instrument <NUM> once attached.

Anvil assembly <NUM> of the present example is also flippable to a substantially T shaped and is coupled to a distal end of shaft assembly <NUM>. As shown in <FIG>, anvil assembly <NUM> comprises an anvil <NUM> and an anvil shaft <NUM> extending proximally from anvil <NUM>. Anvil <NUM> has a central opening and a long circular staple forming surface at a distal end. Housing shaft <NUM> of staple housing assembly <NUM> may go through the opening to be coupled to the closure system of the instrument. Anvil <NUM> may be also linked to anvil shaft <NUM> via a head pivot <NUM>, for example. Like staple housing assembly <NUM>, anvil assembly <NUM> is also configured to be rotatable about a longitudinal axis of head pivot <NUM> between a first, linear configuration and a second, perpendicular configuration. Also, when in the linear configuration, anvil assembly <NUM> has a quite low-profile which allows the entire assembly to go through a <NUM> trocar, and when in the perpendicular configuration, anvil <NUM> pivots to be perpendicular to anvil shaft <NUM> to present a high-profile of T shape.

Since staple housing assembly <NUM> is a separate coupleable component, staple housing assembly <NUM> may be inserted to a portion of tissue in the linear configuration prior to being coupled to the instrument. By way of example only, staple housing assembly <NUM> may be inserted into a first tubular portion of tissue, such as esophagus, while instrument <NUM> is inserted into a second tubular portion of tissue, such as jejunum. And, since staple housing assembly <NUM> and anvil assembly <NUM> can both go through <NUM> trocar in its linear configuration, the stapler according to the present invention can be used in total laparoscopic surgery and thus can be called a laparoscopic stapler. Moreover, the high-profile provided by the T shaped staple housing assembly and anvil assembly allows the stapler according to the present invention to be adapted for a relatively larger lumen to be joined, for example, a lumen with a diameter of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>.

As stated above, staple housing assembly <NUM> is operatively coupleable to the closure system and firing system of instrument <NUM> to staple material clamped between staple housing assembly <NUM> and anvil assembly <NUM>. After staple housing assembly <NUM> is coupled, the closure system is operable to longitudinally translate staple housing assembly <NUM> relative to anvil assembly <NUM> to clamp tissue therebetween. Once appropriate, the firing system comprising a trigger <NUM> may be actuated by a user to drive and fire staples from staple housing assembly.

As shown in <FIG>, staple housing <NUM> of the present example comprises an outer casing <NUM> and an inner casing <NUM>. A push trigger <NUM> is disposed in staple housing <NUM> and configured to be driven proximally in response to the actuation of trigger <NUM>, which in turn may drive a step driver <NUM> proximally. Staple housing <NUM> further includes a blade <NUM> configured to sever tissue when step driver <NUM> is actuated proximally. A plurality of staples <NUM> contained within staple pockets are positioned proximal to step driver <NUM> such that the proximal actuation of step driver <NUM> also drives staples proximally.

According to the present invention, staple housing <NUM> further comprises a plurality of glue pockets <NUM> for containing bio-glue. Glue pockets are provided so that as step driver <NUM> drives staples <NUM> to staple tissue, bio-glue can also be pushed out of staple housing <NUM> into tissue by the same driver. As can be seen from <FIG>, glue pockets <NUM> and staple pockets are disposed in a pair of concentric long circular rows. Blade <NUM> is arranged distal relative to bio-glue and staples. As such, when step driver <NUM> is actuated proximally, it first pushes staples and bio glue out of the respective pocket into tissue for stapling and gluing. Such delivery of bio-glue into tissue may prevent leakage and facilitate tissue heal, and thus providing an improved anastomosis. As step driver <NUM> is further actuated proximally, it drives blade <NUM> out to achieve tissue cutting.

The operation of the laparoscopic stapler according to the present invention is now described with respect to an exemplary jejunum and esophagus anastomosis.

In this laparoscopic approach, anastomosis is made with a delivery channel provided by <NUM> trocar and in the prepared condition, ends of jejunum and esophagus are closed with for example a linear stapler. In a first step, an opening is made at the prepared closed end of esophagus which may be stabilized with a grasper. A staple housing assembly, such as staple housing assembly <NUM> described above is inserted through the made opening in its linear configuration and then the assembly <NUM> is activated to its T shaped configuration to let the housing shaft protrude out of the esophagus end from the opening such that staple housing assembly <NUM> is ready for coupling. Optionally, the assembly <NUM> may be stabilized with a grasper, for example. In the next step, inserting the instrument <NUM> through a <NUM> trocar surgery device and a prepared opening in jejunum with anvil assembly <NUM> in its linear configuration, and then activating the instrument to its T shaped configuration. Jejunum wall is now made to a long circular shaped by the T shaped anvil. In a next step, staple housing assembly <NUM> is coupled to the closure system of instrument and staple housing assembly <NUM> is actuated proximally towards anvil assembly <NUM> to close the gap distance therebetween. Once instrument <NUM> is within operating range, the user actuates trigger <NUM> of instrument <NUM> to drive step driver <NUM> proximally. The actuation of step driver <NUM> pushes staples and bio-glue into tissue for stapling and gluing and also blade to cut overlapping tissue of esophagus and jejunum. With such end-to-end anastomosis having done, the surgeon may return staple housing assembly <NUM> and anvil assembly <NUM> back into their linear configuration, and then the stapler may be removed from the patient through the <NUM> trocar.

Many modifications may be made to the described example. It is envisaged when staple housing assembly <NUM> is coupled to the closure system, the gap distance between a proximal face of staple housing assembly <NUM> and a distal face of anvil assembly <NUM> can be reduced. In this regard, the closure system may be translatable longitudinally relative to anvil assembly <NUM> via an adjusting knob <NUM> located at a proximal end of actuator handle assembly <NUM>. Accordingly, when staple housing assembly <NUM> is coupled to the closure system, rotation of adjusting knob <NUM> reduces gap distance by actuating staple housing assembly <NUM> relative to anvil assembly <NUM>. For instance, staple housing assembly <NUM> is actuated proximally relative to anvil assembly <NUM> from an initial, open position to a closed position, thereby reducing the gap distance and the distance between the two portions of tissue to be joined. Once the gap distance is brought within a predetermined range, staple housing assembly <NUM> may be fired by a user pivoting trigger <NUM> of actuator handle assembly <NUM>.

As noted above, gap distance corresponds to the distance between staple housing assembly <NUM> and anvil assembly <NUM>. When a stapler is inserted into a patient, this gap distance may not be easily viewable. Accordingly, a moveable indicator bar may be provided to be visible through an indicator window positioned on top of actuator handle assembly <NUM>. For example, an indicator bar may be operable to move in response to rotation of adjusting knob <NUM> such that the position of indicator bar is representative of the gap distance. Moreover, indicator window <NUM> may further comprise a scale which indicates that the gap is within a desired operating range and a corresponding staple compression representation at each end of scale. Accordingly, a user can view the position of the coupled staple housing assembly <NUM> relative to the anvil assembly <NUM> via the indicator bar and the scale.

In a further embodiment according to the present invention, anvil control buttons <NUM>, <NUM> corresponding to the activation of anvil assembly <NUM> to its T shaped configuration and to the deactivation of anvil assembly <NUM> to its original, linear configuration are provided on actuator handle assembly <NUM>, as shown in <FIG>. With this arrangement, the user may easily return the stapler back to the low profile for removal through the trocar channel.

Claim 1:
A laparoscopic stapler (<NUM>) for stapling tissue, comprising:
an anvil assembly (<NUM>) comprising an oblong or elliptical anvil (<NUM>) and an anvil shaft (<NUM>) extending proximally from the anvil, wherein the anvil is coupled to the anvil shaft via a first head pivot (<NUM>), wherein the anvil is rotatable about a longitudinal axis of the first head pivot between a first, linear configuration and a second, perpendicular configuration relative to the anvil shaft; and
a staple housing assembly (<NUM>) which can be moved with respect to the anvil assembly, wherein the staple housing assembly comprises an oblong or elliptical staple housing (<NUM>) and a housing shaft (<NUM>) extending proximally from the staple housing, wherein the staple housing is linked to the housing shaft via a second head pivot (<NUM>), and wherein the staple housing is rotatable about a longitudinal axis of head pivot between a first, linear configuration and a second, perpendicular configuration relative to the housing shaft,
wherein the anvil assembly and the staple housing assembly are respectively configured to be operable in the first configuration and the second configuration, wherein in the first configuration, the anvil assembly and the staple housing assembly are configured so that the anvil assembly and the staple housing assembly can be delivered separately through a <NUM> trocar, and in the second configuration, the anvil assembly and the staple housing assembly are configured for performing tissue stapling.