Patent Description:
The staples can be made of a bioabsorbable material such that the staples can dissolve and release the tissue after a sufficient amount of time has elapsed following the surgical procedure. While it is desirable that the staples ultimately dissolve and release the tissue, the staples must maintain their structural integrity for an amount of time, i.e., the biocorrosion timeframe, to allow for sufficient healing of the tissue. When selecting appropriate bioabsorbable materials such that the staples can meet the biocorrosion timeframe, many factors are considered, such as the stiffness of the staples, the strength of the staples, the ductility of the staple materials, the safety of the materials being utilized (such as toxicity concerns), and/or the compatibility of the materials with electrosurgical instruments, for example. Comparatively, stents which are often implanted to hold open an artery, for example, are often comprised of alloys which resist or impede biocorrosion of the underlying structure even though a surface of the stent may comprise a dissolvable coating.

<CIT> describes a sealed sterile package constructed to contain a surgical stapler having moisture-sensitive components, in particular a cartridge at a distal end which contains surgical staples made of a polymer which is subject to hydrolytic degradation. The package includes three layers. A top layer is a preformed plastic layer which is formed with at least one recess for receiving the surgical instrument. The recess is of the general contoured shape of the instrument. This layer is made of transparent material so that the packaged instrument can readily be viewed. A middle layer is a moisture permeable layer which is secured to the plastic layer about the recess. Suitable lines of glue or adhesive, such as a heat sealable adhesive, are used to secure the permeable layer directly to the plastic layer to provide a seal-tight seam. Further, the glue or adhesive which is used is such that the permeable layer is releasably secured to the plastic layer so that the permeable layer can be subsequently removed when desired, for example, by peeling of the permeable layer from the plastic layer. The permeable middle layer is made of a material which is permeable to moisture vapor and sterilant gas while being impervious to microorganisms. A bottom layer is made of a moisture impervious material such as aluminum foil. The moisture impervious layer is secured to and across the permeable layer via a line of adhesive or glue. The package also includes a desiccant pack between the permeable layer and the impervious layer. The desiccant pack is disposed adjacent to the moisture-sensitive component of the surgical instrument, on the side of the permeable layer opposite from the plastic layer and the instrument. The desiccant pack includes silica gel, molecular sieves, activated alumina or porous silica glass. In addition, the desiccant is encased within a pouch of moisture permeable polymeric material. The desiccant pack is of a size which is suitable to the size of the cartridge. The pack need not be fixedly secured in place but need only be placed on the permeable layer prior to fixing of the impervious layer to the permeable layer.

The present invention provides the packaging assembly according to claim <NUM> and its dependent claims. The packaging assembly comprises a surgical staple cartridge configured to be operably installed in a surgical stapling instrument, wherein the surgical staple cartridge comprises a body, a deck, a longitudinal slot defined in the deck, staple cavities defined in the deck, and staples removably stored in the staple cavities, a container configured to store the surgical staple cartridge therein and permit the surgical staple cartridge to be removed therefrom, and a desiccant element. The desiccant element is removably attached to the deck of the surgical staple cartridge and covers the staple cavities in the cartridge body. The container is hermetically sealable with the cartridge and the desiccant element removably attached to the cartridge deck stored therein.

The following description is to be taken in conjunction with the accompanying drawings, in which the present invention as claimed in claim <NUM> is described with reference to <FIG>, <FIG>, <FIG> and <FIG>, and the remaining figures illustrate features of the dependent claims or alternative packaging designs, as follows:.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein are not to be construed as limiting the scope of the invention in any manner.

The terms "proximal" and "distal" are used herein with reference to a clinician manipulating the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion located away from the clinician. It will be further appreciated that, for convenience and clarity, spatial terms such as "vertical", "horizontal", "up", and "down" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.

Various exemplary devices are provided for performing laparoscopic and minimally invasive surgical procedures. However, the reader will readily appreciate that the various devices disclosed herein can be used in numerous surgical procedures and applications including, for example, in connection with open surgical procedures. The reader will further appreciate that the various instruments disclosed herein can be inserted into a body in any way, such as through a natural orifice, through an incision or puncture hole formed in tissue, etc. The working portions or end effector portions of the instruments can be inserted directly into a patient's body or can be inserted through an access device that has a working channel through which the end effector and elongate shaft of a surgical instrument can be advanced.

A surgical stapling system can comprise a shaft and an end effector extending from the shaft. The end effector comprises a first jaw and a second jaw. The first jaw comprises a staple cartridge. The staple cartridge is insertable into and removable from the first jaw; however, other possibilities are envisioned in which a staple cartridge is not removable from, or at least readily replaceable from, the first jaw. The second jaw comprises an anvil configured to deform staples ejected from the staple cartridge. The second jaw is pivotable relative to the first jaw about a closure axis; however, other possibilities are envisioned in which the first jaw is pivotable relative to the second jaw. The surgical stapling system further comprises an articulation joint configured to permit the end effector to be rotated, or articulated, relative to the shaft. The end effector is rotatable about an articulation axis extending through the articulation joint. Other possibilities are envisioned which do not include an articulation joint.

The staple cartridge comprises a cartridge body. The cartridge body includes a proximal end, a distal end, and a deck extending between the proximal end and the distal end. In use, the staple cartridge is positioned on a first side of the tissue to be stapled and the anvil is positioned on a second side of the tissue. The anvil is moved toward the staple cartridge to compress and clamp the tissue against the deck. Thereafter, staples removably stored in the cartridge body can be deployed into the tissue. The cartridge body includes staple cavities defined therein wherein staples are removably stored in the staple cavities. The staple cavities are arranged in six longitudinal rows. Three rows of staple cavities are positioned on a first side of a longitudinal slot and three rows of staple cavities are positioned on a second side of the longitudinal slot. Other arrangements of staple cavities and staples may be possible.

The staples are supported by staple drivers in the cartridge body. The drivers are movable between a first, or unfired position, and a second, or fired, position to eject the staples from the staple cavities. The drivers are retained in the cartridge body by a retainer which extends around the bottom of the cartridge body and includes resilient members configured to grip the cartridge body and hold the retainer to the cartridge body. The drivers are movable between their unfired positions and their fired positions by a sled. The sled is movable between a proximal position adjacent the proximal end and a distal position adjacent the distal end. The sled comprises a plurality of ramped surfaces configured to slide under the drivers and lift the drivers, and the staples supported thereon, toward the anvil.

Further to the above, the sled is moved distally by a firing member. The firing member is configured to contact the sled and push the sled toward the distal end. The longitudinal slot defined in the cartridge body is configured to receive the firing member. The anvil also includes a slot configured to receive the firing member. The firing member further comprises a first cam which engages the first jaw and a second cam which engages the second jaw. As the firing member is advanced distally, the first cam and the second cam can control the distance, or tissue gap, between the deck of the staple cartridge and the anvil. The firing member also comprises a knife configured to incise the tissue captured intermediate the staple cartridge and the anvil. It is desirable for the knife to be positioned at least partially proximal to the ramped surfaces such that the staples are ejected ahead of the knife.

<FIG> depict a surgical stapling instrument <NUM> that is configured to cut and staple tissue of a patient. The surgical stapling instrument <NUM> comprises a handle assembly <NUM>, a shaft assembly <NUM> attached to the handle assembly <NUM>, and a surgical end effector <NUM>. The handle assembly <NUM> comprises a housing <NUM> that is configured to house various components therein such as, for example, electronics, motors, and/or drive train components. The handle assembly <NUM> comprises a pistol grip portion <NUM> comprising a handle <NUM> that is configured to be held by a user, a closure trigger <NUM> that is configured to clamp tissue within the surgical end effector <NUM>, and a firing trigger <NUM> (<FIG>) located forward of the closure trigger <NUM> and which controls actuation of a firing system that is configured to cut and staple tissue that is clamped within the surgical end effector <NUM>. The handle assembly <NUM> further comprises a plurality of actuators and/or buttons <NUM> that are configured to electronically actuate various functions of the surgical stapling instrument <NUM>.

In at least one instance, the handle assembly <NUM> comprises a plurality of motors positioned therein that are configured to drive one or more functions of the surgical stapling instrument <NUM>. The handle assembly <NUM> further comprises one or more power sources such as, for example, batteries <NUM> that are configured to power onboard electronics or control system <NUM> that comprises, for example, the printed circuit boards <NUM>, <NUM> which control the motor(s) positioned within the handle assembly <NUM>. In at least one instance, the handle assembly <NUM> comprises one or more onboard memories, processors, and/or control circuits that are configured to analyze sensor data and/or control various electronic systems of the surgical stapling instrument <NUM> such as, for example, motor control programs. The handle assembly <NUM> may be in wireless communication with a surgical hub and/or various other components of a surgical operating suite to communicate various data between the handle assembly <NUM> and the surgical hub, for example.

In the illustrated arrangement, the shaft assembly <NUM> is attached to the handle assembly <NUM>. In at least one instance, the shaft assembly <NUM> is modular and can be replaced with another shaft assembly of another surgical instrument attachment, for example. In at least one instance, the shaft assembly <NUM> comprises one or more of the printed circuit boards <NUM>, <NUM>. The shaft assembly <NUM> is configured to house a plurality of components of the surgical stapling instrument <NUM> such as, for example, drive shafts, electronics, sensors, wires, and/or frame components, for example. Such components are configured to be coupled to corresponding components that are positioned within the handle assembly <NUM> such as, for example, motors, supply leads, wires, and/or drive train components, for example. The shaft assembly <NUM> houses such components and transfers such components to the surgical end effector <NUM> to drive various functions of the shaft assembly <NUM> and/or surgical end effector <NUM> and/or transfer electrical signals between the shaft assembly <NUM> and the surgical end effector <NUM> and to/from the handle assembly <NUM>, for example. The shaft assembly <NUM> comprises electrical leads <NUM> electrically coupled with one or more of the printed circuit board's <NUM>, <NUM> and one or more components within the shaft assembly <NUM> and/or the surgical end effector <NUM>. Further details regarding the surgical stapling instrument <NUM> may be found in <CIT>, entitled ELECTRICAL LEAD ARRANGEMENTS FOR SURGICAL INSTRUMENTS.

In one form, the surgical end effector <NUM> comprises a first jaw <NUM> and a second jaw <NUM> that is movable relative to the first jaw <NUM> to grasp and ungrasp tissue therebetween. The first jaw <NUM> comprises a cartridge-receiving channel <NUM> that is configured to receive a surgical staple cartridge <NUM> therein. The second jaw <NUM> comprises an anvil <NUM> that is configured to clamp onto tissue upon actuation of the closure trigger <NUM> and form staples removably stored within the surgical staple cartridge <NUM> upon actuation of the firing trigger <NUM>. As discussed above, the surgical stapling instrument <NUM> may comprise various electronics. Such electronics may be wireless, wired, passively powered, and/or actively powered, for example. In various instances, such electronics may be positioned within the surgical staple cartridge <NUM>, on one or more components of the surgical end effector <NUM> such as the cartridge-receiving channel <NUM> and/or the anvil <NUM>, within the shaft assembly <NUM>, and/or within the handle assembly <NUM>.

A surgical staple cartridge <NUM> comprises a cartridge body <NUM> that defines a deck surface <NUM>. A longitudinal slot <NUM> splits the deck surface <NUM> and is configured to receive a tissue-cutting knife or E-beam member <NUM> that has a tissue-cutting surface <NUM> thereon. The E-beam member <NUM> comprises a portion of a firing assembly <NUM>. The deck surface <NUM> further defines longitudinal rows of staple cavities <NUM> in the cartridge body <NUM> located on both sides of the longitudinal slot <NUM>. For instance, a surgical staple cartridge <NUM> can comprise three longitudinal rows 14208A, 14210A, 14212A of staple cavities <NUM> on a first side <NUM> of the longitudinal slot <NUM> and three longitudinal rows 14208B, 14210B, 14212B of staple cavities <NUM> on a second, or opposite, side <NUM> of the longitudinal slot <NUM>. On the first side <NUM> of the longitudinal slot <NUM>, in some cases, the longitudinal rows of staple cavities <NUM> are arranged in an inner row 14208A adjacent the longitudinal slot <NUM>, an intermediate row 14210A adjacent the inner row 14208A, and an outer row 14212A adjacent the intermediate row 14210A. Similarly, on the second side <NUM> of the longitudinal slot <NUM>, the longitudinal rows of staple cavities <NUM> are arranged in an inner row 14208B adjacent the longitudinal slot <NUM>, an intermediate row 14210B adjacent the inner row 14212B, and an outer row 14212B adjacent the intermediate row 14210B.

A staple <NUM> is positioned in each staple cavity <NUM>. Each staple <NUM> is supported on a corresponding staple driver <NUM> that is slidably supported with the staple cavity <NUM>. The staples <NUM> that are positioned in the inner rows, intermediate rows, and outer rows may be comprised of the same material. The staples <NUM> may comprise any of the various bio-absorbable staple compositions/configurations disclosed herein. In at least one such instance, all of the staples <NUM> in the surgical staple cartridge <NUM> are comprised of the same alloy, for example. In still other instances, each staple <NUM> may comprise its own integrally-formed driver.

In at least one arrangement, the staples <NUM> are driven from unfired positions within the cartridge body <NUM> to fired positions by a firing member, such as sled <NUM>, for example. The sled <NUM> comprises wedges <NUM> which are configured to directly engage the staple drivers <NUM> or the driver portion of the staples (whichever the case may be) and lift the staple drivers <NUM> and staples <NUM> toward the anvil <NUM>. The sled <NUM> comprises a wedge, or rail, <NUM> that corresponds to each longitudinal row of staples <NUM>; however, the sled <NUM> may have any suitable number of wedges <NUM>. Each wedge <NUM> comprises an angled drive surface <NUM> which slides under the staple drivers <NUM> or staples as the sled <NUM> is advanced from a proximal end of the surgical staple cartridge <NUM> toward a distal end of the surgical staple cartridge <NUM>.

In various arrangements, the staple drivers <NUM> may be installed in the staple cavities <NUM> in the cartridge body <NUM> and the sled <NUM> may be positioned in the cartridge body <NUM> through openings the bottom of the cartridge body <NUM>. A metal pan <NUM> may be attached to the cartridge body <NUM> by tabs <NUM> formed therein that are configured to retainingly engage the cartridge body <NUM>. The metal pan <NUM> serves to retain the staple drivers <NUM> and the sled <NUM> within the cartridge body <NUM>. Each staple cavity <NUM> opens through the deck surface <NUM>. The staples <NUM> may be inserted onto their respective driver <NUM> through the staple cavity opening in the deck surface <NUM> or they may be installed with their corresponding staple driver through the bottom of the cartridge body <NUM>, for example.

In the illustrated example, the anvil <NUM> comprises an elongate anvil body <NUM> that has a staple-forming undersurface <NUM>. The staple-forming undersurface <NUM> may comprise a series of staple-forming pockets that correspond to each staple <NUM> in a corresponding surgical staple cartridge <NUM> that is operably seated in the cartridge-receiving channel <NUM>. The anvil body <NUM> further comprises a pair of anvil trunnions or pivot pins <NUM> that are pivotally received in corresponding slots <NUM> in the channel <NUM> to facilitate pivotal travel of the anvil <NUM> relative to the channel <NUM> between an open position and a closed position.

A variety of methods and components exist for applying opening and closing motions to the anvil <NUM>. In one instance, for example, such opening and closing motions are applied to the anvil <NUM> by an axially moving closure member or closure tube <NUM>. For example, the closure tube <NUM> may be moved distally by compressing the closure trigger <NUM>. After the firing stroke has been completed, the closure tube <NUM> may be moved proximally back to the starting position by releasing the closure trigger <NUM> which may actuate the closure system in reverse. As the closure tube moves proximally, the closure tube <NUM> may interact with an anvil opening feature or tab <NUM> on the anvil <NUM> to apply opening motions thereto. In addition, a spring (not shown) may be employed to apply opening motions to the anvil <NUM>.

The sled <NUM> is configured to be actuated through a firing stroke by the firing assembly <NUM> to deploy the staples <NUM> from the surgical staple cartridge <NUM> and cut tissue that is clamped between the jaws <NUM>, <NUM>. In various arrangements, the firing assembly <NUM> may comprise an axially movable firing beam <NUM> that interfaces with a firing system within the housing <NUM>. Once the anvil <NUM> has been closed, actuation of a firing trigger <NUM> causes the firing beam <NUM> to move distally. The firing beam <NUM> is coupled to the firing member <NUM> that has a tissue-cutting surface <NUM> thereon. In addition, the firing member <NUM> further comprises a pair of anvil engaging tabs <NUM> that are configured to be slidably received within corresponding slots in the anvil <NUM>. Stated another way, the anvil engaging tabs <NUM> are configured to slidably engage ledges or shoulders (not shown) in the anvil <NUM> and serve to maintain the staple-forming undersurface <NUM> of the anvil <NUM> at a desired spacing relative to the surgical staple cartridge <NUM> during the firing stroke. The firing member <NUM> extends through an elongate slot <NUM> in the metal pan <NUM> and a slot <NUM> in the channel <NUM>. The firing member <NUM> further comprises a pair of channel-engaging tabs <NUM> that are located on the bottom of the firing member <NUM>. In addition, the firing member <NUM> may comprise a pair of laterally-extending central tabs <NUM> configured to slidably engage portions of the cartridge body <NUM>. As the firing member <NUM> is driven distally during the firing stroke, the firing member <NUM> contacts the sled <NUM> and drives the sled <NUM> distally. As the sled <NUM> moves distally, the angled drive surface <NUM> on each wedge <NUM> cammingly interfaces with the corresponding staple drivers <NUM> and causes the staple drivers <NUM> to move toward the anvil <NUM> which causes the staples <NUM> to be ejected from the surgical staple cartridge <NUM> into forming contact with the staple-forming undersurface <NUM> of the anvil <NUM>.

In those instances wherein the staples <NUM> are designed to be bio-absorbable within a desired period of time, it is desirable for the staples <NUM> to be protected from physical and environmental influences that might cause premature degradation of the unfired staples <NUM> during shipping and storage of the surgical staple cartridge <NUM>. <FIG> illustrates one form of a packaging assembly, generally designated as <NUM>, for packaging, storing, and shipping a sterile surgical staple cartridge <NUM> that operably stores staples <NUM> that comprise any of the various bio-absorbable staples disclosed herein.

For example, each of the staples <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> may comprise a zinc-based alloy that is configured to accelerate corrosion of the staples. In another instance, each of the staples <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> may comprise a magnesium-based alloy and be coated with a coating comprised of an absorbable polymer and a calcification inhibitor. In still another instance, for example, each of the staples <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> may be hollow and comprise a magnesium-based alloy. In yet another example, each of the staples <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> may comprise a magnesium-based alloy, wherein an alloying element of the magnesium-based alloy is selected to lower an electrode potential of the staples. In yet another arrangement, each of the staples <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> may comprise a magnesium-based alloy, wherein an alloying element of the magnesium-based alloy is selected to accelerate anodic corrosion of magnesium of the magnesium-based alloy. In another arrangement, at least a portion of each staple <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> is coated in Fetuin A. In other instances, at least a portion of each staple <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> is coated by one or more proteins. In other cases, at least a portion of each staple <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> is coated in citrate. In another arrangement, at least a portion of each staple <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> is coated in a chelating agent. In another arrangement, at least a portion of each staple <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> is coated in phytic acid. In various alternatives, at least a portion of each staple <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> is coated in pyrophosphate. In another arrangement, at least a portion of each staple <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> is coated in a bisphosphonate. In still other arrangements, at least a portion of each staple <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> is coated in a polyphosphate. Alternatively, at least a portion of each staple <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> is coated in a co-polymer of acrylic acid. In other cases, at least a portion of each staple <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> is coated in a polycarboxylic acid. In another instance, at least a portion of each staple <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> is coated in a polymer coating. In another arrangement, at least a portion of each staple <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> is coated in osteopontin. In still another arrangement, at least a portion of each staple <NUM> in the surgical staple cartridge <NUM> or at least some of the staples <NUM> in the surgical staple cartridge <NUM> is coated in magnesium ions.

After the staples <NUM> have been installed in the surgical staple cartridge <NUM>, the surgical staple cartridge <NUM> may then be sterilized utilizing, for example, gamma radiation, x-rays, high-energy electrons, beta radiation, ethylene oxide, plasma peroxide, steam etc. In one arrangement, the packaging assembly <NUM> comprises a staple retainer <NUM> that is removably coupled to the surgical staple cartridge <NUM> to form a cartridge/retainer assembly <NUM>. When coupled to the surgical staple cartridge <NUM>, the staple retainer <NUM> covers the staple cavities <NUM> and serves to retain the staples <NUM> within each staple cavity <NUM> during shipping and storage of the surgical staple cartridge <NUM>. The staple retainer <NUM> is configured to be removed from the surgical staple cartridge <NUM> prior to use of the surgical staple cartridge <NUM>. For example, the staple retainer <NUM> may be removed from the surgical staple cartridge <NUM> prior to installation in the cartridge-receiving channel <NUM> or the cartridge/retainer assembly <NUM> may be installed in the channel <NUM> and thereafter, the staple retainer <NUM> is removed prior to use of the surgical stapling instrument <NUM>. The staple retainer <NUM> may be separately sterilized prior to installation on the surgical staple cartridge <NUM> or the staple retainer <NUM> may be installed onto the surgical staple cartridge <NUM> and the entire cartridge/retainer assembly <NUM> may then be sterilized. After sterilization, the cartridge/retainer assembly <NUM> is then placed into a hermetically-sealed (airtight and fluidtight) sterile container <NUM> for shipping and storage.

One form of a staple retainer <NUM> may be fabricated from a polymer material and comprise an elongate body portion <NUM> that is configured to be received on the deck surface <NUM> of the surgical staple cartridge <NUM>. The elongate body portion <NUM> is sized relative to the deck surface <NUM> such that when the staple retainer <NUM> is received thereon, the elongate body portion <NUM> covers all of the staple cavities <NUM> in the cartridge body <NUM>. In various instances, the body portion <NUM> of the staple retainer <NUM> may be formed with instructional indicia <NUM> and/or identifying indicia that relates to a particular surgical staple cartridge. To facilitate positioning of the staple retainer <NUM> on the deck <NUM>, a downwardly extending locator keel or locator member <NUM> may protrude downward from a deck-facing surface <NUM> of the elongate body portion <NUM> and is configured to be received within the elongate slot <NUM> in the cartridge body <NUM>. In at least one arrangement, the staple retainer <NUM> is formed with a plurality of attachment tabs <NUM> that are configured to retainingly engage corresponding portions of the cartridge body <NUM> to removably affix the staple retainer <NUM> to the cartridge body <NUM>. In at least one instance, the staple retainer <NUM> is configured to prevent the staples <NUM> from falling out of their respective staple cavities <NUM> during shipping and/or installation of the surgical staple cartridge <NUM> into the channel <NUM> of the surgical stapling instrument <NUM> as well as prevents infiltration of debris into the staple cavities <NUM> prior to use.

The staple retainer <NUM> is configured to be removed prior to use of the surgical stapling instrument <NUM> and the surgical staple cartridge <NUM>. To facilitate such removal, the staple retainer <NUM> may comprise a removal tab <NUM> that protrudes from a distal end of the staple retainer <NUM> to facilitate prying of the staple retainer <NUM> from the cartridge body <NUM> of the surgical staple cartridge <NUM>. Various other staple retainer arrangements are disclosed in <CIT>, entitled FASTENER CARTRIDGE ASSEMBLIES AND STAPLE RETAINER COVER ARRANGEMENTS, and <CIT>, entitled TISSUE THICKNESS COMPENSATOR COMPRISING AT LEAST ONE MEDICAMENT.

The packaging assembly <NUM> further comprises a hermetically-sealable (airtight and fluidtight) container <NUM> that is configured to temporarily store one or more cartridge/retainer assemblies <NUM> therein prior to use. Such hermetically-sealable container <NUM> is configured to store and protect the cartridge/retainer assemblies <NUM> after being manufactured and sterilized until the container <NUM> is opened in the operating room, for example. As described in <CIT>, entitled PACKAGING FOR A REPLACEABLE COMPONENT OF A SURGICAL STAPLING SYSTEM, various container arrangements may comprise peel-pouches, woven and/or non-woven material wrappers, rigid containers, etc..

In the examples illustrated in <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>, the container <NUM> comprises a hermetically-sealable peel-pouch <NUM> that is fabricated from a gas and moisture impermeable foil or plastic material. In at least one arrangement, for example, the container <NUM> comprises a first layer <NUM> and a second layer <NUM>. The first layer <NUM> and the second layer <NUM> form a protective barrier around a cartridge/retainer assembly <NUM>. An adhesive bonds the first layer <NUM> and the second layer <NUM> together to form an airtight and fluidtight sealed pouch around the cartridge/retainer assembly <NUM>. The adhesive forms a seal without creases, wrinkles, and/or gaps. The seal created by the adhesive prevents contaminants from coming into contact with the cartridge/retainer assembly <NUM> as well as prevents air/gas/fluid from infiltrating into the interior of the container <NUM>. As discussed in <CIT>, the first layer <NUM> may comprise a first corner <NUM> positioned outside of the seal, and the second layer <NUM> may comprise a second corner <NUM> positioned outside of the seal. The clinician can expose the cartridge/retainer assembly <NUM> by peeling the first layer <NUM> apart from the second layer <NUM>. In various instances, the clinician can expose the sealed cartridge/retainer assembly <NUM> by holding the first corner <NUM> and the second corner <NUM> in separate hands and pulling the first corner <NUM> in a direction away from the second layer <NUM>, although any suitable opening method could be used.

The first layer <NUM> and the second layer <NUM> may be comprised of a material such as, for example, paper with a laminated inner surface. The laminated inner surface provides a gas impermeable and a fluid impermeable barrier to prevent contaminants from entering the sealed portion of the container <NUM>. In one arrangement, the first layer <NUM> and the second layer <NUM> are comprised of foil. In another arrangement, the first layer <NUM> and the second layer <NUM> are comprised of plastic. In various arrangements, the first layer <NUM> and/or the second layer <NUM> can be comprised of a material with a particular degree of transparency to allow a clinician, for example, to observe the contents of the container <NUM>. Additionally, the container <NUM> may comprise any of the various identification features/indicia described in <CIT>.

In various instances, the container <NUM> may be sized relative to a cartridge/retainer assembly <NUM> such that when the cartridge/retainer assembly <NUM> is received therein, the cartridge/retainer assembly <NUM> is substantially non-movably retained in position within the container <NUM>. Although <FIG> illustrates a container <NUM> that is sized to contain one cartridge/retainer assembly <NUM> therein, the container <NUM> may be sized to contain a plurality of cartridge/retainer assemblies <NUM> or surgical staple cartridges <NUM> therein. In either case, the container <NUM> may be sized relative to the cartridge/retainer assemblies <NUM> to substantially prevent movement therein once the container <NUM> is sealed.

As discussed above, in those instances wherein the staples <NUM> are designed to be bio-absorbable within a desired period of time, it is desirable for the staples <NUM> to be protected from physical and environmental influences that might cause premature degradation of the unfired staples <NUM> during shipping and storage of the surgical staple cartridge <NUM>. For example, should the staples <NUM> be exposed to moisture prior to use, the staples <NUM> may begin to undesirably degrade. Thus, it is desirable to prevent the staples from being exposed to moisture while being stored and shipped prior to use. In the arrangement depicted in <FIG>, the packaging assembly <NUM> further comprises a desiccant element <NUM> that is sealed in the container <NUM> with the cartridge/retainer assembly <NUM>. In one arrangement, the desiccant element <NUM> comprises a pouch <NUM> that contains a desiccant material such as, for example, silica gel, activated alumina, etc. that are configured to absorb and ultimately reduce the moisture within the hermetically-sealed container <NUM>. In still other arrangements, the desiccant element <NUM> comprises <NUM>/m<NUM> +/- <NUM>% Invercote T2 paper per P-<NUM>-<NUM> (Adaptiv) or other commercially available moisture absorbent boards.

In various instances, the desiccant element <NUM> may be configured to change color in the presence of moisture. In such instance, the desiccant element <NUM> would provide the clinician with an indication that moisture was present within the container <NUM> and could have caused premature degradation of the bio-absorbable staples <NUM> allowing the clinician to avoid use of the surgical staple cartridge <NUM>. For example, in at least one arrangement, the desiccant element <NUM> may comprise a blue desiccant material containing cobalt chloride which will change to a pink color when the desiccant material has reached its maximum adsorption capacity. This change in color would indicate a compromised package. In another arrangement, for example, the desiccant element <NUM> may comprise a PH sensitive dye that changes color upon exposure to basic environments which may indicate corrosion of Mg to Mg(OH)<NUM>. In another arrangement, the desiccant element <NUM> may be treated with an irreversible hydrochromic dye such as, for example, patent blue V (tryphenylmethane) dye, cobalt II chloride or methyl violet, for example.

In other arrangements, the packaging assembly <NUM> may additionally comprise a tray <NUM> that is configured with a cartridge retention receptacle <NUM> or other retention features that non-movably retain one or more cartridge/retainer assemblies <NUM> or surgical staple cartridges <NUM> in position on the tray <NUM>. In addition, a desiccant element <NUM> may be received within the receptacle <NUM> on top of the cartridge/retainer assembly <NUM> or otherwise positioned therein. When the clinician is ready to use a surgical staple cartridge <NUM>, the container <NUM> is opened and the tray <NUM> is removed or otherwise positioned to allow the clinician to again access to the cartridge/retainer assembly <NUM> and pry or otherwise remove the cartridge/retainer assembly <NUM> out of retaining engagement within the receptacle <NUM> in the tray <NUM>. In certain instances, the surgical staple cartridge <NUM> or the cartridge/retainer assembly <NUM> may be attached to the tray <NUM> during the sterilization process. The tray <NUM>, as well as the staple retainer <NUM>, provides air/fluid paths for a sterilization medium to invade around the surgical staple cartridge <NUM> and be flushed from the interior portions of the cartridge body <NUM>.

<FIG> illustrates an alternative packaging assembly <NUM> that comprises a container <NUM>' that comprises a tray <NUM> of the type and construction described above with a top layer <NUM> removably sealed thereto so as to create a hermetic seal between the top layer <NUM> and the tray <NUM>. In various instances, the tray may comprise a gas and moisture impermeable material and the top layer may comprise a gas and moisture impermeable foil material, for example. The top layer <NUM> may be sealed to the tray <NUM> by an adhesive, for example.

The packaging assembly <NUM> may comprise a desiccant element <NUM> that is configured to be received between the deck surface <NUM> and the deck-facing surface <NUM> of the staple retainer <NUM>. In one arrangement the desiccant element <NUM> comprises a <NUM>/m<NUM> +/- <NUM>% Invercote T2 paper per P-<NUM>-<NUM> (Adaptiv) or other commercially available moisture absorbent board that has a slot <NUM> therein that is configured to accommodate insertion of the retainer keel <NUM> therethrough. In another arrangement, the desiccant element <NUM> comprises a compliant desiccant material. In all of the foregoing arrangements, the desiccant element <NUM> is sized to cover the deck surface <NUM> such that the desiccant element <NUM> covers all of the staple cavities <NUM>. In one arrangement, the desiccant element <NUM> is placed onto the deck surface <NUM> and is held in place by the staple retainer <NUM>. That is, the desiccant element <NUM> is trapped between the deck-facing surface <NUM> of the staple retainer <NUM> and the deck surface <NUM>. In such instance, the desiccant element <NUM> covers each staple cavity <NUM> and serves to absorb moisture occurring therein (if any). The staple retainer <NUM> and the desiccant element <NUM> are removed before the surgical staple cartridge <NUM> can be used. In another arrangement, the desiccant element <NUM> is attached to the deck-facing surface <NUM> of the staple retainer <NUM> with an appropriate adhesive, for example. In such arrangement, the desiccant element <NUM> is removed from the surgical staple cartridge <NUM> when the staple retainer <NUM> is detached therefrom. The desiccant element <NUM> may comprise an adhesive strip (not shown) that is configured to be removably attached to the deck surface <NUM>. In such arrangement, a staple retainer <NUM> may or may not be removably attached to the surgical staple cartridge <NUM> in the above-described manner.

In at least one arrangement, the desiccant element <NUM> may comprise a blue desiccant material containing cobalt chloride which will change to a pink color when the desiccant material has reached its maximum adsorption capacity. This change in color would indicate a compromised package. In another arrangement, for example, the desiccant element <NUM> may comprise a PH sensitive dye that changes color upon exposure to basic environments which may indicate corrosion of Mg to Mg(OH)<NUM>. Alternatively, the desiccant element <NUM> may be treated with an irreversible hydrochromic dye such as, for example, patent blue V (tryphenylmethane) dye, cobalt II chloride or methyl violet, for example.

<FIG> illustrates another desiccant element <NUM> that may comprise a portion of the packaging assembly <NUM>. As can be seen in <FIG>, the desiccant element <NUM> is configured to be received between the deck surface <NUM> and the deck-facing surface <NUM> of the staple retainer <NUM>. In one arrangement the desiccant element <NUM> comprises a <NUM>/m<NUM> +/- <NUM>% Invercote T2 paper per P-<NUM>-<NUM> (Adaptiv) or other commercially available moisture absorbent board that has a slot <NUM> therein that is configured to accommodate insertion of the retainer keel <NUM> therethrough. Additionally, the desiccant element <NUM> is formed with a plurality of individual staple retention protrusions <NUM> that protrude downward from a deck-facing surface <NUM> of the desiccant element <NUM>. In the illustrated arrangement, each retention protrusion is <NUM> is configured to protrude into a corresponding staple cavity <NUM> such that each staple cavity <NUM> has a corresponding staple retention protrusion <NUM> protruding therein when the desiccant element <NUM> is received on the deck <NUM>. Each staple retention protrusion <NUM> is configured to non-movably retain the corresponding staple <NUM> on the corresponding staple driver <NUM> within the corresponding staple cavity <NUM>. Such desiccant element <NUM> immovably restrains the staples <NUM> within their respective staple cavities <NUM> and prevents their movement which might damage or compromise the staple and/or staple coating.

<FIG> illustrates use of another desiccant element <NUM> that is formed as an adhesive strip that is configured to be attached to an upper surface <NUM> of the staple retainer <NUM>. The desiccant element <NUM> may comprise a blue desiccant material containing cobalt chloride which will change to a pink color when the desiccant material has reached its maximum adsorption capacity. This change in color would indicate a compromised package. In another arrangement, for example, the desiccant element <NUM> may comprise a PH sensitive dye that changes color upon exposure to basic environments which may indicate corrosion of Mg to Mg(OH)<NUM>. Alternatively, the desiccant element <NUM> may be treated with an irreversible hydrochromic dye such as, for example, patent blue V (tryphenylmethane) dye, cobalt II chloride or methyl violet, for example.

<FIG> illustrates a cartridge retainer assembly <NUM> sandwiched between an upper desiccant element <NUM> and a lower desiccant element <NUM>. The upper desiccant element <NUM> and the lower desiccant element <NUM> may each comprise a <NUM>/m<NUM> +/- <NUM>% Invercote T2 paper per P-<NUM>-<NUM> (Adaptiv) or other commercially available moisture absorbent board. In other arrangements, the upper desiccant element <NUM> and the lower desiccant element <NUM> may each comprise a compliant desiccant material that offers some cushioning protection to the cartridge/retainer assembly <NUM>. Such arrangement may additionally provide the cartridge retainer assembly <NUM> with cushioning and physical protection from external impacts to the container <NUM>. In one arrangement, the upper desiccant element <NUM> may be affixed to an inner surface of the first layer <NUM> of the container <NUM> by an adhesive. Similarly, the lower desiccant element <NUM> may be affixed to an inner surface of the second layer <NUM> in registration with the upper desiccant element <NUM> such that the cartridge/retainer assembly <NUM> may be positioned therebetween within the container <NUM>. In other arrangements, the upper desiccant element <NUM> may be attached to the upper surface <NUM> of the staple retainer <NUM> with an adhesive and the lower desiccant element <NUM> may be removably attached to the bottom surface of the metal pan <NUM>. In such instance, the clinician would remove the staple retainer <NUM> and the lower desiccant element <NUM> before use. When installed in the container <NUM>, the upper desiccant element <NUM> and the lower desiccant element <NUM> may serve to substantially immovably constrain the cartridge/retainer assembly <NUM> within the container <NUM>. In an alternative arrangement, the cartridge/retainer assembly <NUM> and the upper desiccant element <NUM> and lower desiccant element <NUM> are inserted into a retainer tube <NUM>. In one arrangement, the retainer tube <NUM> may be formed from a transparent polymer material that permits the cartridge/retainer assembly <NUM> to be viewed through the retainer tube <NUM> for identification purposes. Retainer tube <NUM> serves to hold the upper desiccant element <NUM> and lower desiccant element <NUM> in registration with the cartridge/retainer assembly <NUM> within the container <NUM> and affords added protection to the cartridge/retainer assembly <NUM>.

In at least one arrangement, the upper desiccant element <NUM> and/or the lower desiccant element <NUM> may comprise a blue desiccant material containing cobalt chloride which will change to a pink color when the desiccant material has reached its maximum adsorption capacity. This change in color would indicate a compromised package. In another arrangement, for example, the upper desiccant element <NUM> and/or the lower desiccant element <NUM> may comprise a PH sensitive dye that changes color upon exposure to basic environments which may indicate corrosion of Mg to Mg(OH)<NUM>. Alternatively, the upper desiccant element <NUM> and/or the lower desiccant element <NUM> may be treated with an irreversible hydrochromic dye such as, for example, patent blue V (tryphenylmethane) dye, cobalt II chloride or methyl violet, for example.

<FIG> and <FIG> illustrate another desiccant element <NUM> that comprises a tubular-shaped member <NUM> that is configured to receive a surgical staple cartridge <NUM> therein. The desiccant element <NUM> may comprise a <NUM>/m<NUM> +/- <NUM>% Invercote T2 paper per P-<NUM>-<NUM> (Adaptiv) or other commercially available moisture absorbent board. For example, the desiccant element <NUM> comprises a top portion <NUM> that is adapted to cover the staple cavities <NUM> in the deck surface <NUM> when the surgical staple cartridge <NUM> has been inserted therein. The top portion <NUM> is attached to a bottom portion <NUM> by a first side <NUM> that corresponds to a first side <NUM> of the cartridge body <NUM> and a second side <NUM> that corresponds to a second side <NUM> of the cartridge body <NUM> to form a tubular structure sized to receive a surgical staple cartridge <NUM> therein. The bottom portion <NUM> of the desiccant element <NUM> may be substantially coextensive with a bottom portion <NUM> of the cartridge body <NUM> which is defined by the pan <NUM>. A slot <NUM> is provided through the top portion <NUM> to accommodate passage of the retainer keel <NUM> therethrough. The surgical staple cartridge <NUM> is inserted into the desiccant element <NUM> until the slot <NUM> in the top portion <NUM> is in registration with the longitudinal slot <NUM> in the surgical staple cartridge <NUM>. The staple retainer <NUM> may then be attached to the cartridge/element assembly by inserting the retainer keel <NUM> into the slots <NUM> and <NUM>. The proximal-most attachment tabs <NUM> are in registration with corresponding windows <NUM> in the first side <NUM> and the second side <NUM> to engage the cartridge body <NUM>. The desiccant element <NUM> stops short of the distal-most attachment tabs <NUM> such that the distal-most attachment tabs <NUM> may engage the surgical staple cartridge <NUM>. In other instances, the desiccant element <NUM> may be used without a staple retainer <NUM>. In such instance, for example, the top portion <NUM> would not include the longitudinal slot <NUM> and the windows <NUM> would not be provided in first side <NUM> and the second side <NUM>. The surgical staple cartridge <NUM> would be similarly inserted into the desiccant element <NUM> for storage therein. The entire unit is then sealed within a hermetically-sealed container <NUM>.

The desiccant element <NUM> may comprise a blue desiccant material containing cobalt chloride which will change to a pink color when the desiccant material has reached its maximum adsorption capacity. This change in color would indicate a compromised package. In another arrangement, for example, the desiccant element <NUM> may comprise a PH sensitive dye that changes color upon exposure to basic environments which may indicate corrosion of Mg to Mg(OH)<NUM>. Alternatively, the desiccant element <NUM> may be treated with an irreversible hydrochromic dye such as, for example, patent blue V (tryphenylmethane) dye, cobalt II chloride or methyl violet, for example.

<FIG> illustrates use of a desiccant element <NUM> that is formed as a hollow tube that is sized to receive a cartridge/retainer assembly <NUM> therein. The cartridge/retainer assembly <NUM> is inserted into the desiccant element <NUM> and the entire unit is inserted into the container <NUM> for storage and shipping. The desiccant element <NUM> may comprise a blue desiccant material containing cobalt chloride which will change to a pink color when the desiccant material has reached its maximum adsorption capacity. This change in color would indicate a compromised package. In another arrangement, for example, the desiccant element <NUM> may comprise a PH sensitive dye that changes color upon exposure to basic environments which may indicate corrosion of Mg to Mg(OH)<NUM>. In another arrangement, the desiccant element <NUM> may be treated with an irreversible hydrochromic dye such as, for example, patent blue V (tryphenylmethane) dye, cobalt II chloride or methyl violet, for example.

<FIG> illustrates another desiccant element <NUM> that is supported or stored in a hermetically-sealable container <NUM>. In various instances, the desiccant element <NUM> is configured to be removably attached to the deck surface <NUM> of the surgical staple cartridge <NUM>. The desiccant element <NUM> is sized to cover all of the staple cavities <NUM> in the surgical staple cartridge <NUM> and, as such, eliminates a need to employ a separate staple retainer. Stated another way, the desiccant element <NUM> functions as a staple retainer while also providing an additional advantage of moisture absorption. In one arrangement, the desiccant element <NUM> includes two opposing side portions <NUM> that extend downwardly from a top portion <NUM>. The side portions <NUM> may be configured to releasably engage the corresponding sides of the surgical staple cartridge <NUM>. In addition or in the alternative, the desiccant element <NUM> may be removably coupled to the deck surface <NUM> by an adhesive, for example. Alternatively, the desiccant element <NUM> may comprise the top portion <NUM> and not include the side portions <NUM>. In such instance, the desiccant element may be removably attached to the deck surface <NUM> by an adhesive. In various arrangements, the adhesive may comprise a "double stick" or double-sided tape. However, other adhesive materials may be employed to removably or temporarily affix the desiccant element <NUM> to the deck surface <NUM>. In another arrangement, the desiccant element <NUM> may additionally comprise a plurality of staple retention protrusions (see <FIG>) that protrude from the underside of the desiccant element <NUM> and are configured to extend into the staple cavities <NUM> as was discussed above. In one arrangement, the staple retention protrusions serve to non-movably retain the staples <NUM> within their respective cavities <NUM> as well as retain the desiccant element on the deck surface <NUM> during storage and shipping. In other arrangements, however, an adhesive may be employed to removably adhere the desiccant element to the deck surface <NUM>, for example.

The desiccant element <NUM> may comprise a <NUM>/m<NUM> +/- <NUM>% Invercote T2 paper per P-<NUM>-<NUM> (Adaptiv) or other commercially available moisture absorbent board. The desiccant element <NUM> may further comprise a blue desiccant material containing cobalt chloride which will change to a pink color when the desiccant material has reached its maximum adsorption capacity. This change in color would indicate a compromised package. In another arrangement, for example, the desiccant element <NUM> may comprise a PH sensitive dye that changes color upon exposure to basic environments which may indicate corrosion of Mg to Mg(OH)<NUM>. Alternatively, the desiccant element <NUM> may be treated with an irreversible hydrochromic dye such as, for example, patent blue V (tryphenylmethane) dye, cobalt II chloride or methyl violet, for example.

<FIG> illustrates another desiccant element <NUM> that is formed to immovably support a surgical staple cartridge <NUM> or a cartridge/retainer assembly <NUM> during storage and shipping of a cartridge/retainer assembly <NUM> within a hermetically-sealable container <NUM>'. The hermetically-sealable container <NUM>' may be fabricated from rigid plastic or other suitable material that may or may not be transparent. The hermetically-sealable container <NUM> may be configured to support one or a plurality of cartridge/retainer assemblies <NUM> and their respective desiccant elements <NUM>, for example. The hermetically-sealable container <NUM>' may include sides <NUM> that form hermetic seals with each other. One side <NUM> may be hinged or otherwise configured to facilitate opening of the hermetically-sealable container <NUM>'. In other arrangements, for example, the cartridge/retainer assembly <NUM> and desiccant support element <NUM> may be supported in a hermetically-sealable pouch <NUM> or other hermetically-sealable container arrangement, for example.

As can be seen in <FIG>, the desiccant element <NUM> is configured to immovably support the cartridge/retainer assembly <NUM> and serves to protect the cartridge/retainer assembly <NUM> (or surgical staple cartridge <NUM>) and minimize movement thereof during shipping and storage within a hermetically-sealable container <NUM>', for example. In various instances, the desiccant element <NUM> comprises a <NUM>/m<NUM> +/- <NUM>% Invercote T2 paper per P-<NUM>-<NUM> (Adaptiv) or other commercially available moisture absorbent board that can be folded or otherwise fashioned into a supportive structure for the surgical staple cartridge <NUM> or cartridge/retainer assembly <NUM>. The desiccant element <NUM> may further comprise a blue desiccant material containing cobalt chloride which will change to a pink color when the desiccant material has reached its maximum adsorption capacity. This change in color would indicate a compromised package. In another arrangement, for example, the desiccant element <NUM> may comprise a PH sensitive dye that changes color upon exposure to basic environments which may indicate corrosion of Mg to Mg(OH)<NUM>. Alterntively, the desiccant element <NUM> may be treated with an irreversible hydrochromic dye such as, for example, patent blue V (tryphenylmethane) dye, cobalt II chloride or methyl violet, for example. Those of ordinary skill in the art will appreciate that the desiccant element <NUM> may be fashioned into a variety of different supportive structures and configurations configured to non-movably support the surgical staple cartridge <NUM> or cartridge/retainer assembly <NUM>, yet facilitate easy removal therefrom. For example, the desiccant element may comprise a moisture absorbent board that can be folded into a desired shape and retained in that shape by inserting tab portions into corresponding slots and/or using adhesive materials.

Turning next to <FIG>, in one arrangement, the surgical staple cartridge <NUM> comprises an RFID (radio frequency identification) chip or tag <NUM> that is positioned in the cartridge body <NUM>. In the illustrated arrangement for example, the RFID chip <NUM> is positioned in one of the lateral walls <NUM> of the cartridge body <NUM>. A variety of RFID chips/tag configurations and systems are disclosed in further detail in <CIT>. Other RFID chips/tag configurations and systems are disclosed in <CIT>, entitled METHOD OF USING MULTIPLE RFID CHIPS WITH A SURGICAL ASSEMBLY.

The RFID chip <NUM> is associated with and RFID system <NUM> that comprises a scanner <NUM> that is associated with the control system <NUM>. The RFID system <NUM> can either be an active system, a passive system or comprise a combination of active and passive attributes. In passive systems, the onboard RFID chip does not comprise an internal power source and requires a reader or scanner to send a first signal, such as, for example an interrogation signal to the RFID chip. Active radio frequency identification systems also comprise an RFID chip and an RFID scanner. However, the RFID chip in an active RFID system comprises an internal power source. Active RFID systems utilize battery-powered RFID chips that are configured to continuously broadcast their own signal. One type of active RFID chip is commonly referred to as a "beacon. " Such beacon RFID chips do not wait to receive a first signal from an RFID scanner. Instead, the beacon RFID chip continuously transmits its stored information. For example, the beacon can send out its information at an interval of every <NUM>-<NUM> seconds. Another type of active RFID chip comprises a transponder. In such systems, the RFID scanner transmits a signal first. The RFID transponder chip then sends a signal back to the RFID scanner with the relevant information. Such RFID transponder tag systems are efficient, as they conserve battery life when, for example, the RFID chip is out of range of the RFID scanner.

In the illustrated example, the RFID chip <NUM> comprises or is associated with a sensor <NUM> that is configured to track an environmental parameter within the container <NUM>. In one arrangement, for example, the sensor <NUM> comprises a moisture sensor that is configured to monitor a moisture level within the container <NUM>. The RFID chip <NUM> then transmits the moisture-level information to the scanner <NUM> of the control system <NUM>. This transmission of information may occur when the surgical staple cartridge has been seated in the channel <NUM> of the surgical stapling instrument <NUM> or it may be transmitted to the control system <NUM> prior to being seated in the channel <NUM>. To prevent the use of a surgical staple cartridge <NUM> that has been exposed to a moisture level within the container <NUM> that could have conceivably caused premature degrading of the bio-absorbable staples <NUM> therein, in at least one arrangement, the control system <NUM> is configured to prevent a staple firing stroke or other operation from being performed or permit the staple firing stroke or other operation to be performed based on feedback from the RFID system <NUM>. For example, the control system <NUM> can execute the process <NUM> illustrated in <FIG>. Accordingly, the control circuit <NUM> receives <NUM> the detected moisture level information from the RFID chip <NUM>. The detected moisture level information MD is then compared <NUM> to a minimum acceptable level or compatible information MA (which may be substantially zero or some other level determined to not cause premature degradation of the bio-absorbable staples <NUM>). If the detected moisture level information MD is at or below the acceptable moisture level MA, the control system <NUM> permits <NUM> operation of the surgical instrument systems (firing system, closure system). If the detected moisture level information MD exceeds the acceptable moisture level MA, the control system <NUM> prevents <NUM> operation of one or more of the surgical instrument systems.

In various instances, depending upon the particular composition of the staples <NUM> stored in a particular surgical staple cartridge <NUM>, exposure of the staples <NUM> to certain temperatures may, for example, result in age hardening of the staples <NUM> or annealing of the staples <NUM> and/or damage (melting of) to the staple coating. Thus, it is desirable to monitor the temperature level within the container <NUM> while the surgical staple cartridge <NUM> is being stored and shipped therein to ensure that the temperature level has not attained undesirable levels that could cause premature degradation of the staples <NUM>.

In another arrangement, for example, the sensor <NUM> comprises a temperature sensor that is configured to monitor a temperature level within the container <NUM>. The RFID chip <NUM> then transmits the temperature-level information TD to the scanner <NUM> of the control system <NUM>. This transmission of information may occur when the surgical staple cartridge <NUM> has been seated in the cartridge-receiving channel <NUM> of the surgical stapling instrument <NUM> or it may be transmitted to the control system <NUM> prior to being seated in the channel <NUM>. To prevent the use of a surgical staple cartridge <NUM> that has been exposed to a temperature level within the container <NUM> that could have conceivably caused premature degrading of the staples <NUM> therein, in at least one arrangement, the control system <NUM> is configured to prevent a staple firing stroke or other operation from being performed or permit the staple firing stroke or other operation to be performed based on feedback from the RFID system <NUM>. For example, the control system <NUM> can execute the process <NUM> illustrated in <FIG>. Accordingly, the control system <NUM> receives <NUM> the detected temperature level information TD from the RFID chip <NUM>. The detected temperature level information TD is then compared <NUM> to a minimum acceptable level or compatible information TA (determined to not cause premature degradation of the staples <NUM>). If the detected temperature level information TD is at or below the acceptable temperature level TA, the control system <NUM> permits <NUM> operation of the surgical instrument systems (firing system, closure system, etc.).

In another arrangement, for example, the sensor <NUM> is configured to monitor a temperature level as well as a moisture level within the container <NUM>. In other arrangements, a separate temperature sensor and a separate moisture sensor may be used. The separate temperature sensor and the separate moisture sensor may be associated with the RFID chip <NUM> or the separate temperature sensor and the separate moisture sensor may each be associated with a dedicated RFID chip. In either case, the RFID chips would be configured to transmit the detected temperature level information TD and detected moisture level information MD to the scanner <NUM>/control system <NUM>. This transmission of information may occur when the surgical staple cartridge <NUM> has been seated in the cartridge-receiving channel <NUM> of the surgical stapling instrument <NUM> or it may be transmitted to the control system <NUM> prior to being seated in the channel <NUM>. To prevent the use of a surgical staple cartridge <NUM> that has been exposed to a temperature level and/or a moisture level within the container <NUM> that could have conceivably caused premature degrading of the staples <NUM> therein, in at least one arrangement, the control system <NUM> is configured to prevent a staple firing stroke or other operation from being performed or permit the staple firing stroke or other operation to be performed based on feedback from the RFID system <NUM>. For example, the control system <NUM> can execute the process <NUM> illustrated in <FIG>. Accordingly, the control system <NUM> receives <NUM> the detected temperature level information TD and the detected moisture level information MD from the RFID chip(s) <NUM>. The detected temperature level information TD is then compared <NUM> to a minimum acceptable level or compatible information TA (which may be determined to not cause premature degradation of the staples <NUM>). If the detected temperature level information TD exceeds the acceptable temperature level TA, the control system <NUM> prevents <NUM> operation of one or more of the surgical instrument systems. If the detected temperature level information TD is at or below the acceptable temperature level TA, the control system <NUM> then compares <NUM> the detected moisture level information MD to a minimum acceptable level or compatible information MA (determined to not cause premature degradation of the staples <NUM>). If the detected moisture level information MD exceeds the acceptable moisture level MA, the control system <NUM> prevents <NUM> operation of one or more of the surgical instrument systems. If the detected moisture level information MD is at or below the acceptable moisture level MA, the control system <NUM> permits <NUM> operation of the surgical instrument systems (firing system, closure system).

The staples <NUM> may comprise a variety of different compositions and configurations disclosed herein. In certain instances, each composition of the staples <NUM> may have unique sensitivities to a particular moisture level and/or temperature level. Thus, the staples <NUM> in one surgical staple cartridge <NUM> may be more sensitive to a particular moisture and/or temperature level than the staples <NUM> in another surgical staple cartridge that may also be employed in the surgical stapling instrument <NUM>. In such instances, the surgical staple cartridge <NUM> may comprise another RFID chip/tag (not shown) that contains identification information regarding the surgical staple cartridge <NUM> including the particular composition of the staples <NUM> stored therein. This information is then transmitted by the RFID chip/tag to the control system <NUM>. In other arrangements, such information could also be transmitted by RFID chip <NUM>. In either case, the control system <NUM> then looks up/determines the acceptable temperature and/or moisture level information (compatible information) for the particular surgical cartridge <NUM> that has been seated in the channel <NUM> or is slated to be used with the surgical stapling instrument <NUM>. That compatible information for that particular surgical staple cartridge <NUM> is used during the implementation of the processes described herein to determine whether the surgical staple cartridge <NUM> was exposed to unacceptable temperature and/or moisture levels (for the bio-absorbable staples in that particular cartridge) within the container.

<FIG> illustrates a container <NUM> that comprises an indicator member <NUM> that has a sensor <NUM> associated therewith. In one arrangement, the sensor <NUM> comprises a moisture sensor that is configured to detect a moisture level within the container <NUM> and provide a signal to the indicator member <NUM> if the sensed moisture level exceeds a predetermined level which could cause, for example, premature degradation of the bio-absorbable staples <NUM> that are stored in the surgical staple cartridge <NUM>. In one arrangement, the indicator member <NUM> comprises a light emitting diode (LED). The indicator member <NUM> and the sensor <NUM> may each have an onboard power source such that when the moisture level inside of the container <NUM> has exceeded the predetermined level, the LED is illuminated. The clinician would then be informed that the integrity of the staples <NUM> may have been compromised due to exposure to moisture and then avoid use of the surgical staple cartridge <NUM>.

In an alternative arrangement, the sensor <NUM> comprises a temperature sensor that is configured to detect a temperature level within the container <NUM> and provide a signal to the indicator member <NUM> if the sensed temperature level exceeds a predetermined level which could cause, for example, premature degradation of the staples <NUM> that are stored in the surgical staple cartridge <NUM>. In one arrangement, the indicator member <NUM> comprises a light emitting diode (LED). The indicator member <NUM> and the sensor <NUM> may each have an onboard power source such that when the temperature level inside of the container <NUM> has exceeded the predetermined acceptable level, the LED <NUM> is illuminated. The clinician would then be informed that the integrity of the staples <NUM> may have been compromised due to an undesirable temperature within the container <NUM> and then avoid use of the surgical staple cartridge.

In still another arrangement, the sensor <NUM> (or separate sensors) is configured to sense a moisture level and a temperature level within the container <NUM>. If the moisture level exceeds the predetermined level or the temperature exceeds the predetermined level, an LED <NUM> would be illuminated. Alternatively, after the control system <NUM> compares the transmitted moisture level that was detected within the container <NUM> and/or the transmitted temperature level that was detected within the container, the control system <NUM> may activate another indicator that may be onboard the surgical stapling instrument <NUM>. For example, the indicator may comprise an LED, speaker, buzzer, haptic feedback system, notification screed onboard the surgical stapling instrument <NUM> or otherwise associated with the surgical stapling instrument <NUM>, etc. to provide the clinician with an indication that the surgical staple cartridge <NUM> may have been compromised and should not be used. In other instances, the control system may be configured to provide the clinician with an indication of the environmental history of a particular container and the cartridge/retainer assemblies or surgical staple cartridge retained therein. Such environmental history may be presented in table or graph form, for example, that is displayed on a display (not shown) associated with the surgical stapling instrument.

Turning to <FIG>, in various examples, the container <NUM> may be filled with a gas <NUM> to provide the interior of the container <NUM> with a desired environment. For example, the gas <NUM> may comprise dry nitrogen or argon which serves to provide the interior of the container with an extremely low moisture and oxygen environment.

In various examples described herein, the container <NUM> comprises a hermetically-sealable peel-pouch that is fabricated from an air/gas impermeable and moisture impermeable foil or plastic material. In other examples, the container <NUM> is constructed of other suitable materials that can provide a hermetic seal. Other materials for use in constructing the container <NUM> of packaging assembly <NUM> will be apparent to those of ordinary skill in the art. The container <NUM> may also comprise other hermetically-sealable structures that are fabricated from a gas and moisture impermeable material and are configured to store one or more surgical staple cartridges <NUM> and/or one or more of the various cartridge/retainer assemblies <NUM> disclosed herein. Such other container configurations may be fabricated from rigid material such as a plastic and may be formed with cartridge retention cavities or retention features for non-movably retaining one or more surgical staple cartridges <NUM> and/or one or more cartridge/retainer assemblies <NUM> therein while facilitating easy removal therefrom after the container has been opened. In various arrangements, a container may be fabricated from a transparent material or otherwise be configured to permit the contents of the container to be viewed without opening the container. In addition, or in the alternative, identifying indicia, such as, for example RFID tags, bar codes, QR codes, labels etc. may be applied to the outer surface of the container.

The various packaging assemblies, containers, staple retainers, desiccant elements disclosed herein offer solutions to many if not all of the challenges associated with storing and shipping surgical staple cartridges that contain bio-absorbable staples that are designed to degrade within a desired period of time after being formed in tissue. As was discussed above, the absorption of the staples may be driven by the exposure level to O<NUM>, CO<NUM>, and H<NUM>O, which allows the staples to first form oxidation product and then be converted into salts and absorbed. If the staples are exposed to O<NUM>, CO<NUM>, and H<NUM>O, for example, while being stored, shipped and otherwise prior to use, they may prematurely begin to degrade which could detrimentally affect their ability to properly form and retain tissue after deployment into the body for a desired period of time. The various arrangements disclosed herein serve to prevent the surgical staple cartridges containing such bio-absorbable staples from exposure to such elements prior to use while facilitating easy access thereto.

The various bio-absorbable staples disclosed herein may begin to prematurely deteriorate if exposed to moisture and/or higher temperatures. The various packaging assemblies and packaging systems disclosed herein may comprise sensors configured to monitor the moisture level and/or temperature level experienced by the surgical staple cartridge(s) or cartridge /retainer assemblies stored within the hermetically-sealable container. Such sensor arrangements may be associated with indicator members, LED's, etc. in the container and/or be associated with an RFID system in the surgical stapling instrument that is configured to prevent operation of the surgical stapling instrument when the moisture level and/or temperature level within the container has exceeded level(s) that might result in the premature degradation of the bio-absorbable staples. The various desiccant elements disclosed herein may also change color in the presence of moisture to provide the user with an indication that the staples in the surgical staple cartridge have been exposed to moisture and may have begun to prematurely degrade. In other instances, the staples may be treated with a vapor corrosion inhibitor and/or any one of the desiccant element configurations disclosed herein may be fabricated from a material configured to diffuse a vapor corrosion inhibitor therefrom in place of the desiccant material and in other instances in addition to the desiccant material.

Further to the above, some of the bio-absorbable staples disclosed herein are provided with a coating to slow oxidation process. Thus, various container, staple retainers, and desiccant elements disclosed herein serve to non-movably retain the surgical staple cartridges within their respective container and/or non-movably retain each staple within its respective staple cavity. In one arrangement for example, the staples are heated within their respective cavities to cause the coating on the portions of the staples that are in contact with the cavity walls and/or the staple driver to melt the coating to temporarily adhere the staples to the inner walls and/or the staple driver. Such arrangements prevent movement and/or migration of the individual staples and cartridges during storage and shipping which could otherwise damage the staple coating and cause the staples to prematurely degrade. It will also be appreciated that while the various packaging assemblies disclosed herein are particularly well suited for use with surgical staple cartridge that contain bio-absorbable staples, the person of ordinary skill in the art will appreciate that the various packaging assemblies disclosed herein may find equal utility when used in connection with surgical staple cartridges containing other forms of staples and/or fasteners.

As mentioned above, in many instances, after the staples have been installed in the surgical staple cartridge, the surgical staple cartridge is then sterilized utilizing, for example, gamma radiation, x-rays, high-energy electrons, beta radiation, ethylene oxide, plasma peroxide, steam etc. The various staple retainers, desiccant elements, adjuncts and cassettes disclosed herein may be coupled to a surgical staple cartridge prior to sterilization. In such instances, the staple retainers, desiccant elements, adjuncts and cassettes provide air/fluid paths for a sterilization medium to invade and be flushed from the interior portions of the cartridge base.

Various bio-absorbable staples disclosed herein may be coated with a coating to slow the oxidation of the staple core material. Thus, it may be advantageous to prevent or minimize damage to that coating as the staple is being formed through contain with a corresponding staple pocket in the anvil. Thus, any of the packaging assemblies and packaging systems disclosed herein may comprise or additionally comprise a pretreatment element that is configured to apply a pretreatment medium to the staple pockets prior to forming the staples. The pretreatment medium may comprise sodium sterates, silicones, absorbable polymers, and hydrogels. The pretreatment element may be associated with a staple retainer or be separate from the staple retainer and placed between the cartridge deck surface and the anvil after the staple retainer has been detached from the staple cartridge. The pretreatment element may be packaged in a dedicated package/pouch and included in the hermetically-sealable container with the surgical staple cartridge(s) or cartridge/retainer assemblies contained therein.

The various packaging assemblies and packaging systems disclosed herein may include a hermetically-sealable container and a staple retainer. The staple retainer may be configured to prevent movement of each staple within their individual cavity. The packaging assemblies and packaging systems may include a desiccant element contained within the container to absorb and reduce moisture within the container and/or the surgical staple cartridge(s). The desiccant element may be configured to be removably trapped between a staple retainer and a surgical staple cartridge and/or attached to the staple retainer or removably attached to the surgical staple cartridge and used without a staple retainer. The desiccant element may be configured to prevent movement of each staple within their individual cavity. The desiccant element may be configured to change color in the presence of moisture. Multiple desiccant elements may be employed within the container to also isolate the surgical staple cartridge or cartridge/reload assembly from vibration and shock. In other instances, the desiccant element may be configured to non-movably support a surgical staple cartridge or cartridge/retainer assembly therein. The container may be equipped with sensor(s) to detect the moisture level and/or temperature levels in the container and provide indications thereof. The detected levels may be used by the stapling instrument controller to prevent operation of the surgical stapling instrument if the levels exceed acceptable levels.

Different staple cartridges can have different types of staples stored therein. In some cases, a staple cartridge is sold and delivered to a clinician with one or more indicia thereon which indicate to the clinician the type of staples stored in the staple cartridge. The indicia may include words that inform the clinician that pure magnesium and magnesium alloy staples are contained therein. The indicia may include visual representations of the types of staples and their locations with the staple cartridge. For exmple, the indicia comprises a staple pattern than mimics the staples the pattern of staples stored in the enclosed staple cartridge. For instance, if the pure magnesium staples are stored in the proximal end and the distal end of the staple cartridge and the magnesium alloy staples are stored in between the proximal end and the distal end, solid black lines can be used as representations of the magnesium alloy staples while dashed black lines can be used as representations of the pure magnesium alloy staples. The dashed black lines, as opposed to the solid black lines, signify that the pure magnesium staples may bioabsorb faster than the magnesium alloy staples. Similarly, thick solid lines can be used to represent staples having a thicker wire diameter while thin solid lines can be used to represent staple staples having a thinner wire diameter, for example.

The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, a device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps including, but not limited to, the disassembly of the device, followed by cleaning or replacement of particular pieces of the device, and subsequent reassembly of the device. In particular, a reconditioning facility and/or surgical team can disassemble a device and, after cleaning and/or replacing particular parts of the device, the device can be reassembled for subsequent use. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly.

Claim 1:
A packaging assembly (<NUM>) comprising:
a surgical staple cartridge (<NUM>) configured to be operably installed in a surgical stapling instrument (<NUM>), wherein the surgical staple cartridge (<NUM>) comprises a body (<NUM>), a deck (<NUM>), staple cavities (<NUM>) defined in the deck (<NUM>), and staples (<NUM>) removably stored in the staple cavities (<NUM>);
a container (<NUM>) configured to store the surgical staple cartridge (<NUM>) therein and permit the surgical staple cartridge (<NUM>) to be removed therefrom; and
a desiccant element (<NUM>, <NUM>, <NUM>);
characterized in that:
the staple cartridge further comprises a longitudinal slot (<NUM>) defined in the deck (<NUM>);
the desiccant element is removably attached to the deck (<NUM>) of the surgical staple cartridge (<NUM>) and covers the staple cavities (<NUM>) in the cartridge deck (<NUM>); and
the container (<NUM>) is hermetically sealable with the cartridge (<NUM>) and the desiccant element removably attached to the cartridge deck (<NUM>) stored therein.