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 for some patients. However, existing circular staplers are not a feasible option for modem 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.

<CIT> discloses a surgical stapling device for clamping and stapling tissue, and for dispensing a fluid such as an adhesive onto the tissue. The adhesive can be stored within one or more rigid chambers within removable cartridge and dispensed from a plurality of passageways within the cartridge. A plurality of staples and staple drivers are located in the cartridge and may be isolated from the fluid. Both linear and rotary members can be provided to dispense the fluid from the cartridge. Alternately, the fluid can be dispensed from the cartridge at any time with an operator actuatable control. A removable staple cartridge cover can be provided to seal the fluid in the cartridge and prevent fluid loss. Alternately, a fluid cartridge can be provided that can mount within a surgical stapling device and dispense one or more firings of a fluid therefrom.

<CIT> discloses an instrument that is configured to receive a staple cartridge to staple tissue and expel a fluid from within a container in the staple cartridge. The staple cartridge has an upper deck including staple apertures and orifices formed therein. The orifices are in fluid communication with the containers. The staple cartridge includes staple drivers having a driver body to translate a staple and a container protrusion to expel the fluid out the orifices. The fluid may be expelled while driving the staples out through the staple apertures. The container may be vertically compressible container or, in one alternative, may be a container having a channel and a sealant that is configured to be pierced as the fluid is expelled. Some configurations for the fluid include a hemostatic agent, thrombin, a gel, or a medicament. The containers may also be formed as reservoirs defined within the upper deck and/or cartridge body.

It is, therefore, an object of the present invention to provide a laparoscopic stapler for better anastomosis with less leakage and improved tissue heal.

Accordingly, a laparoscopic stapler for stapling tissue is provided according to claim <NUM>. Other embodiments are set out in the dependent claims.

The following description of certain examples of the technology should not be used to limit its scope which is defined by the appended claims. <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 rounded 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 rounded 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 jujunum. 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 rounded 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 rounded 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 a staple housing assembly (<NUM>) operable to drive staples (<NUM>) toward an anvil assembly (<NUM>) to perform tissue stapling, wherein the staple housing assembly (<NUM>) comprises a pocket (<NUM>) for containing bio-glue, and a corresponding staple pocket for containing a staple,
wherein the staple housing assembly further comprises a step driver for pushing the staple and bio-glue from the respective pockets so that upon tissue stapling, the bio-glue is released and delivered into tissue clamped between the staple housing assembly (<NUM>) and the anvil assembly (<NUM>) for tissue gluing,
characterised in that
the staple housing assembly (<NUM>) and the anvil assembly (<NUM>) are both substantially T shaped assemblies.