Patent Description:
Circular stapling instruments may be used in endoscopic procedures, laparoscopic procedures, or through natural body orifices, for fastening tissue. The circular stapling instruments may be powered or manually-operated and may include a tool assembly that is configured to operably couple to a distal end of an elongated member that extends from a handle assembly, e.g., adapter assembly. The handle assembly may be reusable and the tool assembly may be disposable. The tool assembly may include an anvil assembly and a cartridge assembly that houses one or more fasteners therein.

In use, a circular stapling instrument (or circular surgical staplers) may be used to reattach rectum portions that were previously transected. In this instance, a physician may insert a distal end (including an anvil assembly) of the circular stapling instrument into a rectum of a patient and maneuver the distal end up the colonic tract of the patient toward the transected rectum portions. The physician may also insert the remainder of the circular stapling instrument (including the cartridge assembly) through an incision and toward the transected rectum portions. The anvil and cartridge assemblies are approximated toward one another and staples are ejected from the cartridge assembly toward the anvil assembly to form the staples in tissue to affect an end-to-end anastomosis.

After the end-to-end anastomosis is formed, and before the circular stapling instrument is removed from the surgical site, an irrigation catheter or other accessory may be used to leak test the anastomosis. When pressure testing the anastomosis, some amount of pressure is lost due to a lack of seal around the anus.

Therefore, it may be beneficial to provide a seal assembly for circular stapling instruments that aids in forming a seal between the circular stapling instrument and the patient.

Document <CIT> discloses a circular stapling instrument comprising an adapter assembly, a shell assembly comprising a cartridge and an inflatable seal assembly disposed proximal to the shell assembly.

A further circular stapling instrument comprising inflatable seal assemblies is known from <CIT>. This instrument can comprise also a fluid delivery device.

The present invention concerns a circular stapling instrument according to claim <NUM>.

In other aspects of the disclosure, the inflatable member is slidably disposed about the tubular body of the adapter assembly when in the deflated condition. The shell assembly may include a cross-section having a third diameter. The third diameter may be greater than the first diameter. The second diameter may be greater than the third diameter. The seal assembly may further include an inflation tube for providing fluid to the inflatable member. The inflatable member may be substantially annular. The inflatable member may be an inflatable cuff or an inflatable sleeve.

A method of sealing a tubular body organ following a stapling procedure to perform a leak test includes inserting a distal portion of a shell assembly of the circular stapling instrument into an entrance to the tubular body organ, performing a stapling procedure, and inflating an inflatable member proximal of the shell assembly to create a seal between the distal portion of the circular stapling instrument and the tubular body organ is also disclosed but not part of the present invention.

The above and other aspects, features, and advantages of this disclosure will be apparent in light of the following detailed description when taken in conjunction with the accompanying drawings, which are incorporated in and constitute a part of this specification, wherein:.

Aspects of this disclosure will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. Throughout this description, the term "proximal" refers to a portion of a structure, or component thereof, that is closer to a user, and the term "distal" refers to a portion of the structure, or component thereof, that is farther from the user. Directional reference terms, such as "top," "bottom," "side," and the like, are used to ease description of the aspects and are not intended to have any limiting effect on the ultimate orientation of a structure or any part thereof. In the following description, well-known functions or constructions are not described in detail to avoid obscuring this disclosure in unnecessary detail.

<FIG> illustrates a powered circular stapling instrument <NUM> in accordance with aspects of the disclosure. Generally, circular stapling instrument <NUM> includes a housing or handle assembly <NUM> having an actuator <NUM>, and an adapter assembly <NUM> extending distally from and releasably secured to the handle assembly <NUM>. As shown, the adapter assembly <NUM> includes a curved tubular body 16a. However, it is envisioned that tubular body 16a of the adapter assembly <NUM> may be linear to suit a particular surgical procedure, e.g., mucosectomy, hemorrhoidectomy. A tool assembly <NUM> (e.g., a multi-use loading unit, or a single-use loading unit) is coupled to or is configured to operably couple to a distal end of the adapter assembly <NUM> and includes an end effector <NUM>. In certain aspects of the disclosure, a proximal portion of the tool assembly <NUM> is formed as a single component with the adapter assembly <NUM>. Although the aspects of the disclosure are shown and described with regards to a powered circular stapling instrument <NUM>, it is envisioned that the aspects of the disclosure are equally applicable with manual circular stapling instruments.

The end effector <NUM> of the tool assembly <NUM> includes a shell assembly <NUM> configured to support a cartridge assembly <NUM>. The cartridge assembly <NUM> supports a plurality of fasteners (not shown) and a corresponding plurality of pusher members (not shown) that are operatively engageable with the plurality of fasteners to eject the plurality of fasteners from the cartridge assembly <NUM>.

The end effector <NUM> of the tool assembly <NUM> also includes an anvil assembly <NUM> that is supported to move in relation to the cartridge assembly <NUM> between spaced and approximated positions. The anvil assembly <NUM> includes a plurality of pockets or depressions (not shown) that are each configured to receive and form a fastener of the plurality of fasteners when the plurality of fasteners are deployed from cartridge assembly <NUM>.

The adapter assembly <NUM> includes an irrigation/suction assembly <NUM> and a seal assembly <NUM>. The irrigation assembly <NUM> is supported on a distal portion of the adapter assembly <NUM> and operably engages the shell assembly <NUM> of the tool assembly <NUM>. More particularly, the irrigation assembly <NUM> includes a flexible tube <NUM>, a distal coupling <NUM> secured to a distal portion of the flexible tube <NUM>, and a proximal coupling <NUM> secured to a proximal portion of the flexible tube <NUM>. The distal coupling <NUM> is configured to connect the flexible tube <NUM> with the shell assembly <NUM>, and the proximal coupling <NUM> is configured to connect the flexible tube <NUM> with a source of irrigation fluid (not shown) and a source of suction (not shown). It is envisioned that the sources of irrigation fluid and suction may be the same.

In certain aspects of the disclosure, the distal coupling <NUM> of the irrigation assembly <NUM> is integrally formed with the shell assembly <NUM>. Alternatively, the irrigation assembly <NUM> may form an accessory that is releasably securable to the adapter assembly <NUM> and/or the shell assembly <NUM>.

The flexible tube <NUM> of the irrigation assembly <NUM> extends longitudinally at least partially along the tubular body 16a of the adapter assembly <NUM> (<FIG>) and may be fixedly secured to a portion of the circular stapling instrument <NUM> (e.g., the shell assembly <NUM>, the adapter assembly <NUM>, and/or the handle assembly <NUM>) via one or more suitable securement methods (e.g., low tack adhesives, clips, bands, press- or friction-fit, etc.), not explicitly shown. It is further envisioned that flexible tube <NUM> can be any reasonable length and may extend beyond the circular stapling instrument <NUM>. Although shown as described as being flexible, it is envisioned that the flexible tube <NUM> may be rigid.

The irrigation assembly <NUM> is provided to pressure test the anastomosis following a stapling procedure. The irrigation assembly <NUM> may also be provided to facilitate in insertion of the end effector <NUM> into a tubular body of a patient. For a detailed description of the structure and function of exemplary irrigation assemblies, please refer to <CIT> (hereinafter, "the '<NUM> patent").

<FIG> illustrates the seal assembly <NUM> separated from the adapter assembly <NUM>. As shown, the seal assembly <NUM> defines an accessory that may be selectively secured to the adapter assembly <NUM> of the circular stapling instrument <NUM> (<FIG>). Alternatively, the seal assembly <NUM> may be incorporated into either or both of the adapter assembly <NUM> and the irrigation assembly <NUM>.

The seal assembly <NUM> includes an inflatable cuff <NUM> and an inflation tube <NUM> secured to the inflatable cuff <NUM>. The inflatable cuff <NUM> is configured to be received about the tubular body 16a of the adapter assembly <NUM> and the flexible tube <NUM> of the irrigation assembly <NUM>. It is envisioned that the inflatable cuff <NUM> may form a fluid tight seal with the tubular body 16a and the flexible tube <NUM> prior to inflation of the inflatable cuff <NUM>.

In certain aspects of the disclosure, and as shown, to accommodate the tubular body 16a of the adapter assembly <NUM> and the flexible tube <NUM> of the irrigation assembly <NUM>, and to ensure a fluid tight seal between the inflatable cuff <NUM> and the adapter assembly <NUM>, the inflatable cuff <NUM> includes a central opening <NUM> sized to receive the tubular body 16a of the adapter assembly <NUM> and a channel <NUM> in fluid communication with the central opening <NUM> sized to receive the flexible tube <NUM> of the irrigation assembly <NUM>. More particularly, the central opening <NUM> includes a substantially circular shape corresponding to a cross-sectional shape of the tubular body 16a and the channel <NUM> includes a substantially semicircular shape corresponding to a cross-sectional shape of the flexible tube <NUM>. It is envisioned that central opening <NUM> may have any shape corresponding to alternative configurations of the tubular body 16a and the channel <NUM> may have any shape corresponding with alternative configurations of the flexible tube <NUM>. When the seal assembly <NUM> is properly secured to the adapter assembly <NUM>, the tubular body 16a is disposed within the central opening <NUM> of the inflatable cuff <NUM> and the flexible tube <NUM> is disposed within the channel <NUM> of the inflatable cuff <NUM>.

The inflatable cuff <NUM> may be formed of any suitable material. Although shown as being formed from an elastic material that stretches between deflated and inflated conditions, it is envisioned that the inflatable cuff <NUM> may instead form a collapsible bag (not shown) which may be disposed in a tear-away cover. In other aspects of the disclosure, the inflatable cuff <NUM> is textured, coated, or otherwise configured to form a fluid tight seal between the inflatable cuff <NUM> and the tubular body 16a of the adapter assembly <NUM> and the flexible tube <NUM> of the irrigation assembly <NUM>, e.g., inwardly, and/or between the inflatable cuff <NUM> and a tubular organ, e.g., anus "An" of a patient "P", e.g., outwardly. It is envisioned that the inflatable cuff <NUM> is moveable along the tubular body 16a of the adapter assembly <NUM> when the inflatable cuff <NUM> is in the deflated condition, and is fixed relative to the tubular body 16a when the inflatable cuff <NUM> is in the inflated condition.

A distal portion of the inflation tube <NUM> is secured to the inflatable cuff <NUM> in any suitable manner. It is envisioned that the inflation tube <NUM> may be incorporated into the flexible tube <NUM> and/or distal and proximal coupling <NUM>, <NUM>. A proximal portion of the inflation tube <NUM> is configured to be secured to a source of inflation fluid (not shown). It is envisioned that the inflatable cuff <NUM> may be inflated with liquid, e.g., saline, and/or gas, e.g., nitrogen. Inflation may occur manually, e.g., rubber bulb, or automatically, e.g., pressurized gas. The seal assembly <NUM> may include a valve (not shown) for selective release of the inflation fluid.

<FIG> illustrates the seal assembly <NUM> with the inflatable cuff <NUM> operably disposed about the tubular body 16a of the adapter assembly <NUM> and the flexible tube <NUM> of the irrigation assembly <NUM>, and in a deflated condition. It is envisioned that the seal assembly <NUM> may be provided with the adapter assembly <NUM> or provided as a separate accessory. Alternatively, the seal assembly <NUM> may be integrally formed with the adapter assembly <NUM> and/or the irrigation assembly <NUM>. When provided as a separate accessory, the seal assembly <NUM> may be received about the tubular body 16a of the adapter assembly <NUM> by stretching the inflatable cuff <NUM> like a rubber band and guiding it over the end effector <NUM>. The location of the inflatable cuff <NUM> along the tubular body 16a of the adapter assembly <NUM> may be adjusted depending on the size of the patient "P", the procedure being performed.

In the deflated condition, an outer diameter of the inflatable cuff <NUM> measures a first length "d1". The first length "d1" is less that the length or dimension of the diameter of a cross-section of the shell assembly <NUM>. In this manner, the inflatable cuff <NUM> is maintained within the diameter of the shell assembly <NUM> and does not require any further dilation of the tubular organ of the patient.

<FIG> illustrates the seal assembly <NUM> with the inflatable cuff <NUM> in an inflated condition. In the inflated condition, an outer diameter of the inflatable cuff <NUM> measures a second length "d2". The second length "d2" is greater than the first length "d1", and as shown, may be greater than the cross-sectional diameter of the shell assembly <NUM>. The inflated inflatable cuff <NUM> includes an annular shape with rounded or smooth surfaces.

<FIG> illustrates the end effector <NUM> of the circular stapling instrument <NUM>, including the irrigation assembly <NUM> and seal assembly <NUM> received within a tubular organ, e.g., the anus "An" of a patient "P". The inflatable cuff <NUM> of the seal assembly <NUM> may be coated, include a cover, or be otherwise configured to facilitate positioning of the inflatable cuff <NUM> within the anus "An" of the patient "P". Depending on the position of the anastomosis and/or the size of the patient "P", the position of the inflatable cuff <NUM> on the tubular body <NUM> of the adapter assembly <NUM> may be adjusted. As shown, the inflatable cuff <NUM> is positioned along the tubular body <NUM> of the adapter assembly 16a such inflatable cuff <NUM> is within the entrance of the anus "An". It is envisioned that the inflatable cuff <NUM> may instead be received entirely within the anus "An".

<FIG> illustrates the inflatable cuff <NUM> of the seal assembly <NUM> in the inflated condition. In the inflated condition, the inflatable cuff <NUM> forms a seal between the tubular body 16a of the adapter assembly <NUM> and the anus "An" of the patient "P". The inflatable cuff <NUM> may be inflated while in the anus "An" or the inflatable cuff <NUM> may be inflated and then pressed into the anus "An" by the clinician using the handle assembly <NUM>.

It is envisioned that the surgical stapling procedure would be performed prior to the inflating of the inflatable cuff <NUM> of the seal assembly <NUM>. In this manner, the inflatable cuff <NUM> of the seal assembly <NUM> need not be positioned within any particularity along the tubular body 16a of the adapter assembly <NUM>.

Once inflated, a leak test is performed as described in the '<NUM> patent to test the integrity of the newly formed anastomosis, or other stapling procedure. The leak test of the anastomosis may be performed without concern for loss of pressure about the tubular body 16a of the adapter assembly <NUM> as the inflatable cuff <NUM> of the seal assembly <NUM> prevents any leaks.

Upon completion of the leak test, the inflatable cuff <NUM> of the seal assembly <NUM> may be deflated and the end effector <NUM> of the circular stapling instrument <NUM> (<FIG>) removed from the anus "An". It is envisioned that the inflatable cuff <NUM> may be used as a dilator to facilitate removal of the end effector <NUM>.

The irrigation assembly <NUM> and the seal assembly <NUM> may be provided as a part of a kit with a surgical stapling instrument, e.g., circular stapling instrument <NUM> (<FIG>).

<FIG> illustrate a seal assembly <NUM> operably positioned within the anus "An" of a patient. The inflatable sleeve <NUM> is substantially similar to the inflatable cuff <NUM> described hereinabove, and therefore will only be described in detail as relates to the differences therebetween.

The seal assembly <NUM> includes an inflatable sleeve <NUM>. The inflatable sleeve <NUM> is disposed about the tubular body 16a of the adapter assembly <NUM>, and is transitionable between a deflated condition (<FIG>) and an inflated condition (<FIG>).

In use, the inflatable sleeve <NUM> of the seal assembly <NUM> is inserted within the anus "An" of the patient prior to inflation. In this manner, a clinician does not have to provide any external pressure to the circular stapling instrument <NUM> (<FIG>) to ensure a seal between the adapter assembly <NUM> and the patient "P".

Claim 1:
A circular stapling instrument (<NUM>) for performing an anastomosis, comprising:
an adapter assembly (<NUM>) including a tubular body (16a) having a distal portion;
a shell assembly (<NUM>) disposed on the distal portion of the tubular body (16a), the shell assembly supporting a staple cartridge assembly (<NUM>); and
a seal assembly (<NUM>, <NUM>) supported on the tubular body (16a), the seal assembly including an inflatable member (<NUM>, <NUM>) disposed proximal of the shell assembly (<NUM>), wherein the inflatable member includes a first diameter when in a deflated condition and a second diameter when in an inflated condition, the second diameter being larger than the first diameter,
characterised in that the circular stapling instrument further comprises an irrigation assembly (<NUM>), the irrigation assembly including a flexible tube (<NUM>), wherein the irrigation assembly is configured to deliver an irrigation fluid to pressure test the anastomosis following a stapling procedure.