Patent Description:
Surgical staplers are used in surgical procedures to close openings in tissue, blood vessels, ducts, shunts, or other objects or body parts involved in the particular procedure. The openings can be naturally occurring, such as passageways in blood vessels or an internal organ like the stomach, or they can be formed by the surgeon during a surgical procedure, such as by puncturing tissue or blood vessels to form a bypass or an anastomosis, or by cutting tissue during a stapling procedure.

Most staplers have a handle with an elongate shaft having a pair of movable opposed jaws formed on an end thereof for holding and forming staples therebetween. The staples are typically contained in a staple cartridge, which can house multiple rows of staples and is often disposed in one of the two jaws for ejection of the staples to the surgical site. In use, the jaws are positioned so that the object to be stapled is disposed between the jaws, and staples are ejected and formed when the jaws are closed and the device is actuated. Some staplers include a knife configured to travel between rows of staples in the staple cartridge to longitudinally cut and/or open the stapled tissue between the stapled rows.

While surgical staplers have improved over the years, a number of problems still present themselves. One common problem is that leaks can occur due to the staple forming holes when penetrating the tissue or other object in which it is disposed. Blood, air, gastrointestinal fluids, and other fluids can seep through the openings formed by the staples, even after the staple is fully formed. The tissue being treated can also become inflamed due to the trauma that results from stapling. Still further, staples, as well as other objects and materials that can be implanted in conjunction with procedures like stapling, generally lack some characteristics of the tissue in which they are implanted. For example, staples and other objects and materials can lack the natural flexibility of the tissue in which they are implanted. A person skilled in the art will recognize that it is often desirable for tissue to maintain as much of its natural characteristics as possible after staples are disposed therein. <CIT> discloses an anvil-attachable layer and a retainer for aligning and attaching the layer to an anvil of a surgical stapler. Embodiments of the anvil-attachable layer can include one or more attachment features extending from the layer. A retainer can push the attachment features into a knife slot in the anvil so that the fit between the attachment features and the slot hold the anvil-attachable layer in place.

Accordingly, there remains a need for improved devices and methods for stapling tissue, blood vessels, ducts, shunts, or other objects or body parts such that leaking and inflammation is minimized while substantially maintaining the natural characteristics of the treatment region.

In one aspect, an end effector for a surgical instrument is provided that includes a first jaw, a second jaw, and at least one recess formed in at least one jaw of the first and second jaws. The first jaw has a cartridge with a plurality of staple cavities configured to seat staples therein, the staple cavities opening on a tissue-facing surface of the cartridge. The second jaw opposing the first jaw has an anvil with a plurality of staple forming cavities formed on a tissue-facing surface thereof. The first and second jaws are configured to clamp tissue therebetween. The end effector includes an adjunct material having at least one projection configured to mate with the at least one recess to retain the adjunct material on the at least one jaw, the at least one projection being disposed at least at proximal and distal ends of the adjunct material. The end effector also includes a removable applicator member configured to apply force to the adjunct material so as to cause the at least one projection of the adjunct to be received in a corresponding recess formed in the at least one jaw to thereby cause the adjunct material to be releasably mated with the at least one jaw.

The end effector can vary in any of various ways. For example, the at least one projection can be in the form of at least one first discrete projection formed at a distal end of the adjunct material and at least one second discrete projection formed at a proximal of the adjunct material, wherein the at least one recess formed in the at least one jaw is in the form of a first recess formed at a distal end of the at least one jaw and a second recess formed at a proximal end of the at least one jaw.

The applicator member can have a variety of configurations. For example, the applicator member can be removably coupled to the at least one jaw. In some embodiments, the applicator member can be configured to releasably hold the adjunct material so as to release the adjunct material when the applicator member is clamped between the first and second jaws. In some embodiments, the applicator member can include at least one applicator member projection facing the adjunct material and formed on the applicator member at a location thereof corresponding to a location of the at least one projection of the adjunct material. When the applicator member is configured to apply the force to the adjunct material, the at least one applicator member projection is configured to cause the at least one projection of the adjunct material to be at least partially received in the at least one recess.

According to the invention, the end effector further includes a polymer attachment layer configured to be positioned between the at least one jaw and the adjunct material, the polymer attachment layer including at least one second projection facing the at least one jaw and formed on the polymer attachment layer at a location thereof corresponding to a location of the at least one projection of the adjunct material. When the applicator member is configured to apply the force to the adjunct material and to the polymer attachment layer positioned between the at least one jaw and the adjunct material, the at least one applicator member projection is configured to cause the at least one projection of the adjunct material and the at least one second projection of the polymer material to be at least partially received in the at least one recess.

In some embodiments, the at least one projection of the adjunct material includes or is in the form of a first longitudinal projection formed on one side of the adjunct material and a second longitudinal projection formed on another, opposite side of the adjunct material, the first and second longitudinal projections extending between distal and proximal ends of the adjunct material.

In some embodiments, at least one of the first and second longitudinal projections can have a mating feature formed thereon that is configured to be at received within a corresponding recess of the at least one recess. The at least one longitudinal projection can be formed from at least partially flexible material such that, as the at least one longitudinal projection is received within a corresponding recess, the longitudinal projection is contracted due to the force being applied by the applicator member and then expanded to be fittingly received within the recess.

In some embodiments , the at least one projection formed on the adjunct material includes or is in the form of a plurality of discrete projections formed from an at least partially flowable material and having a changeable configuration such that, when the applicator member applies the force to the adjunct material to cause each of the discrete projections to be at least partially received within a corresponding recess in the at least one jaw, the configuration of each discrete projection that is at least partially received within the corresponding recess changes to conform to a configuration of the corresponding recess. Each of the discrete projections is configured to separate from the adjunct material and remain within the recess after the staples are formed against the staple forming cavities to apply the adjunct material to a tissue clamped between the first and second jaws.

In another aspect, an end effector for a surgical instrument is provided that includes a first jaw, a second jaw, a plurality of recesses formed in at least one jaw of the first and second jaws, an adjunct material formed from at least partially stretchable material, and an applicator member. The first jaw has a cartridge with a plurality of staple cavities configured to seat staples therein, the staple cavities opening on a tissue-facing surface of the cartridge. The second jaw opposing the first jaw has an anvil with a plurality of staple forming cavities formed on a tissue-facing surface thereof. The first and second jaws are configured to clamp tissue therebetween. The applicator member has a plurality of projections, each of the plurality of projections being configured to mate with a corresponding recess in the at least one jaw, and the applicator member is configured to apply force to the adjunct material so as to cause each projection formed on the applicator member to be received in a corresponding recess formed in the at least one jaw to thereby cause a portion the adjunct material disposed between the at least one jaw and the applicator member to be releasably retained in the corresponding recess in the at least one jaw.

The end effector can vary in any of various ways. For example, at least one of the plurality of recesses formed in the at least one jaw can have at least one retaining feature configured to releasably retain the portion of the adjunct material in the corresponding recess.

Particular attention is drawn to <FIG>. All other figures, along with their corresponding description, are included for background to aid understanding.

This disclosure will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:.

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices, systems, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims.

It will be appreciated that the terms "proximal" and "distal" are used herein with reference to a user, such as a clinician, gripping a handle of an instrument. Other spatial terms such as "front" and "back" similarly correspond respectively to distal and proximal. It will be further appreciated that for convenience and clarity, spatial terms such as "vertical" and "horizontal" are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these spatial terms are not intended to be limiting and absolute.

The devices may be fired directly by a human user or remotely under the direct control of a robot or similar manipulation tool. However, a person skilled in the art will appreciate that the various methods and devices disclosed herein can be used in numerous surgical procedures and applications. Those skilled in the art 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, or through an access device, such as a trocar cannula. For example, 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 elongated shaft of a surgical instrument can be advanced.

It can be desirable to use one or more biologic materials and/or synthetic materials, collectively referred to herein as "adjuncts," in conjunction with surgical instruments to help improve surgical procedures. While a variety of different surgical end effectors can benefit from the use of adjuncts, in some exemplary embodiments the end effector can be a surgical stapler. When used in conjunction with a surgical stapler, the adjunct(s) can be disposed between and/or on jaws of the stapler, incorporated into a staple cartridge disposed in the jaws, or otherwise placed in proximity to the staples. When staples are deployed, the adjunct(s) can remain at the treatment site with the staples, in turn providing a number of benefits. For example, the adjunct(s) may reinforce tissue at the treatment site, preventing tearing or ripping by the staples at the treatment site. Tissue reinforcement may be needed to keep the staples from tearing through the tissue if the tissue is diseased, is healing from another treatment such as irradiation, medications such as chemotherapy, or other tissue property altering situation. In some instances, the adjunct(s) may minimize tissue movement in and around the staple puncture sites that can occur from tissue deformation that occurs after stapling (e.g., lung inflation, gastrointestinal tract distension, , etc.). Furthermore, in some circumstances, an adjunct can be useful in distributing pressure applied by the staple thereby reducing the possibility of a staple pulling through a tissue (which can be friable) and failing to fasten the tissue as intended (so-called "cheese wiring"). Additionally, the adjunct can be at least partially stretchable and can thus allow at least partial natural motion of the tissue (e.g., expansion and contraction of lung tissue during breathing). In some embodiments, a staple line can be flexible as described, for example, in <CIT> entitled "Method for Creating a Flexible Staple Line," filed on September <NUM>, <NUM>.

It will be recognized by one skilled in the art that a staple puncture site may serve as a stress concentration and that the size of the hole created by the staple will grow when the tissue around it is placed under tension. Restricting the tissues movement around these puncture sites can minimize the size the holes may grow to under tension. In some instances, the adjunct(s) can be configured to wick or absorb beneficial fluids, e.g., sealants, blood, glues, that further promote healing, and in some instances, the adjunct(s) can be configured to degrade to form a gel, e.g., a sealant, that further promotes healing. In some instances, the adjunct(s) can be used to help seal holes formed by staples as they are implanted into tissue, blood vessels, and various other objects or body parts. The adjunct(s) may also affect tissue growth through the spacing, positioning and/or orientation of any fibers or strands associated with the adjunct(s).

A variety of surgical instruments can be used in conjunction with the adjunct(s) and/or medicant(s) disclosed herein. "Adjuncts" are also referred to herein as "adjunct materials. " The surgical instruments can include surgical staplers. A variety of surgical staplers can be used, for example, linear surgical staplers and circular staplers. In general, a linear stapler can be configured to create longitudinal staple lines and can include elongate jaws with a cartridge coupled thereto containing longitudinal staple rows. The elongate jaws can include a knife or other cutting element capable of creating a cut between the staple rows along tissue held within the jaws. In general, a circular stapler can be configured to create annular staple lines and can include circular jaws with a cartridge containing annular staple rows. The circular jaws can include a knife or other cutting element capable of creating a cut inside of the rows of staples to define an opening through tissue held within the jaws. The staplers can be used on a variety of tissues in a variety of different surgical procedures, for example in thoracic surgery or in gastric surgery.

<FIG> illustrates one example of a linear surgical stapler <NUM> suitable for use with one or more adjunct(s) and/or medicant(s). The stapler <NUM> generally includes a handle assembly <NUM>, a shaft <NUM> extending distally from a distal end 12d of the handle assembly <NUM>, and an end effector <NUM> at a distal end 14d of the shaft <NUM>. The end effector <NUM> has opposed lower and upper jaws <NUM>, <NUM>, although other types of end effectors can be used with the shaft <NUM>, handle assembly <NUM>, and components associated with the same. As shown in <FIG>, the lower jaw <NUM> has a staple channel <NUM> (see <FIG>) configured to support a staple cartridge <NUM>, and the upper jaw <NUM> has an anvil surface <NUM> that faces the lower jaw <NUM> and that is configured to operate as an anvil to help deploy staples of the staple cartridge <NUM> (the staples are obscured in <FIG> and <FIG>). At least one of the opposed lower and upper jaws <NUM>, <NUM> is moveable relative to the other lower and upper jaws <NUM>, <NUM> to clamp tissue and/or other objects disposed therebetween. In some implementations, one of the opposed lower and upper jaws <NUM>, <NUM> may be fixed or otherwise immovable. In some implementations, both of the opposed lower and upper jaws <NUM>, <NUM> may be movable. (Movable about a hinge and can also be rotationally moved about the axis of the shaft) Components of a firing system (number?) can be configured to pass through at least a portion of the end effector <NUM> to eject the staples into the clamped tissue. In various implementations a knife blade <NUM> (see <FIG>) or other cutting element can be associated with the firing system to cut tissue during the stapling procedure. The cutting element can be configured to cut tissue at least partially simultaneously with the staples being ejected. In some circumstances, it may be advantageous if the tissue is cut after the staples have been ejected and the tissue is secured. Thus, if a surgical procedure requires that a tissue captured between the jaws be severed, the knife blade <NUM> is advanced to sever the tissue grasped between the jaws after the staples have been ejected from the staple cartridge <NUM>.

Operation of the end effector <NUM> can begin with input from a user, e.g., a clinician, a surgeon, etc., at the handle assembly <NUM>. The handle assembly <NUM> can have many different configurations designed to manipulate and operate the end effector <NUM> associated therewith. In the illustrated example, the handle assembly <NUM> has a pistol-grip type housing <NUM> with a variety of mechanical and/or electrical components disposed therein to operate various features of the instrument <NUM>. For example, the handle assembly <NUM> can include a rotation knob <NUM> mounted adjacent the distal end 12d thereof which can facilitate rotation of the shaft <NUM> and/or the end effector <NUM> with respect to the handle assembly <NUM> about a longitudinal axis L of the shaft <NUM>. The handle assembly <NUM> can further include clamping components as part of a clamping system actuated by a clamping trigger <NUM> and firing components as part of the firing system that are actuated by a firing trigger <NUM>. The clamping and firing triggers <NUM>, <NUM> can be biased to an open position with respect to a stationary handle <NUM>, for instance by a torsion spring. Movement of the clamping trigger <NUM> toward the stationary handle <NUM> can actuate the clamping system, described below, which can cause the jaws <NUM>, <NUM> to collapse towards each other and to thereby clamp tissue therebetween. Movement of the firing trigger <NUM> can actuate the firing system, described below, which can cause the ejection of staples from the staple cartridge <NUM> disposed therein and/or the advancement the knife blade <NUM> to sever tissue captured between the jaws <NUM>, <NUM>. A person skilled in the art will recognize that various configurations of components for a firing system, mechanical, hydraulic, pneumatic, electromechanical, robotic, or otherwise, can be used to eject staples and/or cut tissue.

As shown in <FIG>, the end effector <NUM> of the illustrated implementation has the lower jaw <NUM> that serves as a cartridge assembly or carrier and the opposed upper jaw <NUM> that serves as an anvil. The staple cartridge <NUM>, having a plurality of staples therein, is supported in a staple tray <NUM>, which in turn is supported within a cartridge channel of the lower jaw <NUM>. The upper jaw <NUM> has a plurality of staple forming pockets (not shown), each of which is positioned above a corresponding staple from the plurality of staples contained within the staple cartridge <NUM>. The upper jaw <NUM> can be connected to the lower jaw <NUM> in a variety of ways, although in the illustrated implementation the upper jaw <NUM> has a proximal pivoting end 34p that is pivotally received within a proximal end 56p of the staple channel <NUM>, just distal to its engagement to the shaft <NUM>. When the upper jaw <NUM> is pivoted downwardly, the upper jaw <NUM> moves the anvil surface <NUM> and the staple forming pockets formed thereon move toward the opposing staple cartridge <NUM>.

Various clamping components can be used to effect opening and closing of the jaws <NUM>, <NUM> to selectively clamp tissue therebetween. As illustrated, the pivoting end 34p of the upper jaw <NUM> includes a closure feature 34c distal to its pivotal attachment with the staple channel <NUM>. Thus, a closure tube <NUM>, whose distal end includes a horseshoe aperture 46a that engages the closure feature 34c, selectively imparts an opening motion to the upper jaw <NUM> during proximal longitudinal motion and a closing motion to the upper jaw <NUM> during distal longitudinal motion of the closure tube <NUM> in response to the clamping trigger <NUM>. As mentioned above, in various implementations, the opening and closure of the end effector <NUM> may be effected by relative motion of the lower jaw <NUM> with respect to the upper jaw <NUM>, relative motion of the upper jaw <NUM> with respect to the lower jaw <NUM>, or by motion of both jaws <NUM>, <NUM> with respect to one another.

The firing components of the illustrated implementation includes a firing bar <NUM>, as shown in <FIG>, having an E-beam <NUM> on a distal end thereof. The firing bar <NUM> is encompassed within the shaft <NUM>, for example in a longitudinal firing bar slot <NUM> of the shaft <NUM>, and guided by a firing motion from the handle <NUM>. Actuation of the firing trigger <NUM> can affect distal motion of the E-beam <NUM> through at least a portion of the end effector <NUM> to thereby cause the firing of staples contained within the staple cartridge <NUM>. As illustrated, guides <NUM> projecting from a distal end of the E-Beam <NUM> can engage a wedge sled <NUM>, shown in <FIG>, which in turn can push staple drivers <NUM> upwardly through staple cavities <NUM> formed in the staple cartridge <NUM>. Upward movement of the staple drivers <NUM> applies an upward force on each of the plurality of staples within the cartridge <NUM> to thereby push the staples upwardly against the anvil surface <NUM> of the upper jaw <NUM> and create formed staples.

In addition to causing the firing of staples, the E-beam <NUM> can be configured to facilitate closure of the jaws <NUM>, <NUM>, spacing of the upper jaw <NUM> from the staple cartridge <NUM>, and/or severing of tissue captured between the jaws <NUM>, <NUM>. In particular, a pair of top pins and a pair of bottom pins can engage one or both of the upper and lower jaws <NUM>, <NUM> to compress the jaws <NUM>, <NUM> toward one another as the firing bar <NUM> advances through the end effector <NUM>. Simultaneously, the knife <NUM> extending between the top and bottom pins can be configured to sever tissue captured between the jaws <NUM>, <NUM>.

In use, the surgical stapler <NUM> can be disposed in a cannula or port and disposed at a surgical site. A tissue to be cut and stapled can be placed between the jaws <NUM>, <NUM> of the surgical stapler <NUM>. Features of the stapler <NUM> can be maneuvered as desired by the user to achieve a desired location of the jaws <NUM>, <NUM> at the surgical site and the tissue with respect to the jaws <NUM>, <NUM>. After appropriate positioning has been achieved, the clamping trigger <NUM> can be pulled toward the stationary handle <NUM> to actuate the clamping system. The clamping trigger <NUM> can cause components of the clamping system to operate such that the closure tube <NUM> advances distally through at least a portion of the shaft <NUM> to cause at least one of the jaws <NUM>, <NUM> to collapse towards the other to clamp the tissue disposed therebetween. Thereafter, the firing trigger <NUM> can be pulled toward the stationary handle <NUM> to cause components of the firing system to operate such that the firing bar <NUM> and/or the E-beam <NUM> are advanced distally through at least a portion of the end effector <NUM> to effect the firing of staples and optionally to sever the tissue captured between the jaws <NUM>, <NUM>.

Another example of a surgical instrument in the form of a linear surgical stapler <NUM> is illustrated in <FIG>. The stapler <NUM> can generally be configured and used similar to the stapler <NUM> of <FIG>. Similar to the surgical instrument <NUM> of <FIG>, the surgical instrument <NUM> includes a handle assembly <NUM> with a shaft <NUM> extending distally therefrom and having an end effector <NUM> on a distal end thereof for treating tissue. Upper and lower jaws <NUM>, <NUM> of the end effector <NUM> can be configured to capture tissue therebetween, staple the tissue by firing of staples from a cartridge <NUM> disposed in the lower jaw <NUM>, and/or to create an incision in the tissue. In this implementation, an attachment portion <NUM> on a proximal end of the shaft <NUM> can be configured to allow for removable attachment of the shaft <NUM> and the end effector <NUM> to the handle assembly <NUM>. In particular, mating features <NUM> of the attachment portion <NUM> can mate to complementary mating features <NUM> of the handle assembly <NUM>. The mating features <NUM>, <NUM> can be configured to couple together via, e.g., a snap fit coupling, a bayonet type coupling, etc., although any number of complementary mating features and any type of coupling can be used to removably couple the shaft <NUM> to the handle assembly <NUM>. Although the entire shaft <NUM> of the illustrated implementation is configured to be detachable from the handle assembly <NUM>, in some implementations, the attachment portion <NUM> can be configured to allow for detachment of only a distal portion of the shaft <NUM>. Detachable coupling of the shaft <NUM> and/or the end effector <NUM> can allow for selective attachment of a desired end effector <NUM> for a particular procedure, and/or for reuse of the handle assembly <NUM> for multiple different procedures.

The handle assembly <NUM> can have one or more features thereon to manipulate and operate the end effector <NUM>. By way of non-limiting example, a rotation knob <NUM> mounted on a distal end of the handle assembly <NUM> can facilitate rotation of the shaft <NUM> and/or the end effector <NUM> with respect to the handle assembly <NUM>. The handle assembly <NUM> can include clamping components as part of a clamping system actuated by a movable trigger <NUM> and firing components as part of a firing system that can also be actuated by the trigger <NUM>. Thus, in some implementations, movement of the trigger <NUM> toward a stationary handle <NUM> through a first range of motion can actuate clamping components to cause the opposed jaws <NUM>, <NUM> to approximate toward one another to a closed position. In some implementations, only one of the opposed jaws <NUM>, <NUM> can move to move the jaws <NUM>, <NUM> to the closed position. Further movement of the trigger <NUM> toward the stationary handle <NUM> through a second range of motion can actuate firing components to cause the ejection of the staples from the staple cartridge <NUM> and/or the advancement of a knife or other cutting element (not shown) to sever tissue captured between the jaws <NUM>, <NUM>.

One example of a surgical instrument in the form of a circular surgical stapler <NUM> is illustrated in <FIG>. The stapler <NUM> can generally be configured and used similar to the linear staplers <NUM>, <NUM> of <FIG> and <FIG>, but with some features accommodating its functionality as a circular stapler. Similar to the surgical instruments <NUM>, <NUM>, the surgical instrument <NUM> includes a handle assembly <NUM> with a shaft <NUM> extending distally therefrom and having an end effector <NUM> on a distal end thereof for treating tissue. The end effector <NUM> can include a cartridge assembly <NUM> and an anvil <NUM>, each having a tissue-contacting surface that is substantially circular in shape. The cartridge assembly <NUM> and the anvil <NUM> can be coupled together via a shaft <NUM> extending from the anvil <NUM> to the handle assembly <NUM> of the stapler <NUM>, and manipulating an actuator <NUM> on the handle assembly <NUM> can retract and advance the shaft <NUM> to move the anvil <NUM> relative to the cartridge assembly <NUM>. The anvil <NUM> and cartridge assembly <NUM> can perform various functions and can be configured to capture tissue therebetween, staple the tissue by firing of staples from a cartridge <NUM> of the cartridge assembly <NUM> and/or can create an incision in the tissue. In general, the cartridge assembly <NUM> can house a cartridge containing the staples and can deploy staples against the anvil <NUM> to form a circular pattern of staples, e.g., staple around a circumference of a tubular body organ.

In one implementation, the shaft <NUM> can be formed of first and second portions (not shown) configured to releasably couple together to allow the anvil <NUM> to be detached from the cartridge assembly <NUM>, which may allow greater flexibility in positioning the anvil <NUM> and the cartridge assembly <NUM> in a body of a patient. For example, the first portion of the shaft <NUM> can be disposed within the cartridge assembly <NUM> and extend distally outside of the cartridge assembly <NUM>, terminating in a distal mating feature. The second portion of the shaft <NUM> can be disposed within the anvil <NUM> and extend proximally outside of the cartridge assembly <NUM>, terminating in a proximal mating feature. In use, the proximal and distal mating features can be coupled together to allow the anvil <NUM> and cartridge assembly <NUM> to move relative to one another.

The handle assembly <NUM> of the stapler <NUM> can have various actuators disposed thereon that can control movement of the stapler. For example, the handle assembly <NUM> can have a rotation knob <NUM> disposed thereon to facilitate positioning of the end effector <NUM> via rotation, and/or the trigger <NUM> for actuation of the end effector <NUM>. Movement of the trigger <NUM> toward a stationary handle <NUM> through a first range of motion can actuate components of a clamping system to approximate the jaws, i.e. move the anvil <NUM> toward the cartridge assembly <NUM>. Movement of the trigger <NUM> toward the stationary handle <NUM> through a second range of motion can actuate components of a firing system to cause the staples to deploy from the staple cartridge assembly <NUM> and/or cause advancement of a knife to sever tissue captured between the cartridge assembly <NUM> and the anvil <NUM>.

The illustrated examples of surgical stapling instruments <NUM>, <NUM>, <NUM> provide only a few examples of many different configurations, and associated methods of use, that can be used in conjunction with the disclosures provided herein. Although the illustrated examples are all configured for use in minimally invasive procedures, it will be appreciated that instruments configured for use in open surgical procedures, e.g., open linear staplers as described in <CIT>, can be used in conjunction with the disclosures provided herein. Greater detail on the illustrated examples, as well as additional examples of surgical staplers, components thereof, and their related methods of use, are provided in <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, entitled "Sealing Materials for Use in Surgical Procedures, and filed on November <NUM>, <NUM>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>.

As indicated above, various implantable adjuncts are provided for use in conjunction with surgical stapling instruments. The adjuncts can have a variety of configurations, and can be formed from various materials. In general, an adjunct can be formed from one or more of a film, a foam, an injection molded thermoplastic, a vacuum thermoformed material, a fibrous structure, and hybrids thereof. The adjunct can also include one or more biologically-derived materials and one or more drugs. Each of these materials is discussed in more detail below.

An adjunct can be formed from a foam, such as a closed-cell foam, an open-cell foam, or a sponge. An example of how such an adjunct can be fabricated is from animal derived collagen, such as porcine tendon, that can then be processed and lyophilized into a foam structure. Gelatin can also be used and processed into a foam. Examples of various foam adjuncts are further described in previously mentioned <CIT>.

An adjunct can also be formed from a film formed from any suitable material or a combination of materials discussed below. The film can include one or more layers, each of which can have different degradation rates. Furthermore, the film can have various regions formed therein, for example, reservoirs that can releasably retain therein one or more medicants in a number of different forms. The reservoirs having at least one medicant disposed therein can be sealed using one or more different coating layers which can include absorbable or non-absorbable polymers. The film can be formed in various ways. For example, it can be an extruded or a compression molded film. The medicants can also be adsorbed onto the film or bound to the film via non-covalent interactions such as hydrogen bonding.

An adjunct can also be formed from injection molded thermoplastic or a vacuum thermoformed material. Examples of various molded adjuncts are further described in <CIT>. The adjunct can also be a fiber-based lattice which can be a woven fabric, knitted fabric or non-woven fabric such as a melt-blown, needle-punched or thermal-constructed loose woven fabric. An adjunct can have multiple regions that can be formed from the same type of lattice or from different types of lattices that can together form the adjunct in a number of different ways. For example, the fibers can be woven, braided, knitted, or otherwise interconnected so as to form a regular or irregular structure. The fibers can be interconnected such that the resulting adjunct is relatively loose. Alternatively, the adjunct can include tightly interconnected fibers. The adjunct can be in a form of a sheet, tube, spiral, or any other structure that can include compliant portions and/or more rigid, reinforcement portions. The adjunct can be configured such that certain regions thereof can have more dense fibers while others have less dense fibers. The fiber density can vary in different directions along one or more dimensions of the adjunct, based on an intended application of the adjunct.

The adjunct can be formed from woven, knitted, or otherwise interconnected fibers, which allows the adjunct to be stretched. For example, the adjunct can be configured to stretch in a direction along its longitudinal axis and/or in a lateral direction that is perpendicular to the longitudinal axis. While being stretchable in at least two dimensions (e.g., X and Y directions), the adjunct can provide reinforcement along its thickness (e.g., a Z direction) such that it stretches but resists tearing and pull-through by the staples. Non-limiting examples of adjuncts that are configured to be implanted such that they can stretch with the tissue are described in the above-mentioned <CIT>.

The adjunct can also be a hybrid construct, such as a laminate composite or melt-locked interconnected fiber. Examples of various hybrid construct adjuncts are further described in <CIT>, and in <CIT>.

The adjuncts in accordance with the described techniques can be formed from various materials. The materials can be used in various embodiments for different purposes. The materials can be selected in accordance with a desired therapy to be delivered to tissue so as to facilitate tissue in-growth. The materials can include bioabsorbable and biocompatible polymers, including homopolymers and copolymers. Bioabsorbable polymers can be absorbable, resorbable, bioresorbable, or biodegradable polymers. An adjunct can also include active agents, such as active cell culture (e.g., diced autologous tissue, agents used for stem cell therapy (e.g., Biosutures and Cellerix S. ), hemostatic agents, and tissue healing agents.

The adjuncts can releasably retain therein at least one medicant that can be selected from a large number of different medicants. Medicants include, but are not limited to, drugs or other agents included within, or associated with, the adjuncts that have a desired functionality. The medicants include, but are not limited to, for example, antimicrobial agents such as antibacterial and antibiotic agents, antifungal agents, antiviral agents, anti-inflammatory agents, growth factors, analgesics, anesthetics, tissue matrix degeneration inhibitors, anti-cancer agents, hemostatic agents, and other agents that elicit a biological response. The adjuncts can also be made from or include agents that enhance visibility during imaging, such as, for example, echogenic materials or radio-opaque materials.

Examples of various adjuncts and various techniques for releasing medicants from adjuncts are further described in <CIT> entitled "Medicant Eluting Adjuncts and Methods of Using Medicant Eluting Adjuncts" and filed August <NUM>, <NUM>.

According to the invention an adjunct material is configured to be releasably retained on a jaw of an end effector for a surgical instrument using complementary mating features formed on the jaw and on the adjunct. In particular, the adjunct material can have discrete or longitudinal projections formed thereon at least at distal and proximal ends of the adjunct material. The projections are configured to be received within the complementary recesses formed in a jaw of the end effector to thereby releasably mate the adjunct material with the jaw. According to the invention the end effector includes an attachment feature in the form of a polymer attachment layer that can be used to attach the adjunct material to the jaw.

Furthermore, the end effector includes a removable applicator member configured to apply force to the adjunct material to cause the adjunct material to be releasably retained on the jaw. The applicator member can be in the form of an applicator or retainer removably coupled to the end effector, or in the form of a frame-like applicator configured to releasably hold the adjunct material, or in other forms. Thus, in some implementations, in use, the applicator member is removably coupled to the end effector and used to apply force to the adjunct material (and in some embodiments to a polymer attachment layer) to cause the projections of the adjunct material (and in some embodiments projections formed on the polymer attachment layer) to be at least partially received within corresponding recesses formed in the jaw. In other implementations, a frame-like applicator member holding at least one adjunct material is clamped between the jaws of the end effector. In this way, force is applied to the applicator member, which causes the applicator member to release the at least one adjunct material and to transfer the at least one adjunct material to at least one respective jaw of the end effector. After use, the applicator member can be separated from the end effector.

The described techniques can also employ other ways and structures to releasably retain an adjunct material on at least one jaw of an end effector of a surgical instrument.

<FIG> illustrate an example of an end effector <NUM> configured to releasably retain an adjunct material on one or both of its first and second opposed jaws configured to clamp tissue therebetween, in accordance with the invention. The end effector <NUM>, partially illustrated in <FIG> and <FIG>, has a first jaw having a cartridge body <NUM> and a second jaw having an anvil <NUM>. The cartridge body <NUM> is configured to releasably retain thereon an implantable adjunct material <NUM>. The end effector <NUM> can be coupled to a distal end of a shaft of the surgical instrument (not shown). The end effector <NUM> can be used in any suitable surgical instrument, for example, a linear surgical stapler (e.g., stapler <NUM> in <FIG>, stapler <NUM> in <FIG>, or any other surgical stapler) which can be suitable for use with at least one adjunct.

As shown in <FIG>, the cartridge body <NUM> has a plurality of staple-holding cavities <NUM> configured to seat staples therein, the staple-holding cavities <NUM> opening on a tissue-facing surface <NUM> of the cartridge <NUM>. The staple cavities <NUM> form a certain pattern on the surface of the cartridge <NUM> which corresponds to a pattern of staple-forming cavities (obscured in <FIG>) formed in the anvil <NUM>. The cartridge body <NUM>, also referred to as a cartridge, includes a cutting element channel <NUM> extending between distal and proximal ends 102d, 102p of the cartridge <NUM>. The knife channel <NUM> is configured to receive a cutting element (e.g., a knife) as it moves distally therethrough. As shown in <FIG>, the staple cavities <NUM> can form three rows on both sides of the cutting element channel <NUM>, though it should be appreciated that the staple cavities <NUM> can form any other patterns on the tissue-facing surface <NUM>.

The cartridge body <NUM> can be in the form of a staple channel configured to support a staple cartridge, which can be removably and replaceably seated within the staple channel. Furthermore, in some embodiments, the cartridge <NUM> can be part of a disposable loading unit coupled distally to a shaft of a surgical instrument.

The end effector <NUM> has the implantable adjunct material (or "adjunct") releasably mounted on one or both of the cartridge <NUM> and the anvil <NUM>. In the illustrated implementation, the adjunct material <NUM> releasably retained on the cartridge <NUM> is discussed, though it should be appreciated that the anvil <NUM> can also have an adjunct material releasably retained thereon. As shown in <FIG> and <FIG>, the end effector also includes a loading member <NUM> configured to apply force to the adjunct material <NUM> to cause the adjunct material <NUM> to be retained on the cartridge <NUM>, as discussed in more detail below. As also shown in <FIG> and <FIG>, and additionally illustrated in <FIG>, the end effector <NUM> can further include a polymer attachment layer <NUM> configured to be positioned between the cartridge <NUM> and the adjunct material <NUM>, as also discussed in more detail below.

In the illustrated implementation, the cartridge <NUM> can have at least one recess formed therein that opens on its tissue-facing surface <NUM>, with the at least one recess being configured to mate with a respective projection formed in the adjunct <NUM>. Thus, as shown in <FIG> and <FIG>, the cartridge <NUM> has at least one first recess 112d formed at the distal end 102d thereof and at least one second recess 112p formed at the proximal end 102p thereof. In the example illustrated, some of the recesses are obscured by the adjunct <NUM>, and the at least one first recess 112d is in the form of two recesses formed on opposite sides of the cutting element channel <NUM>. The at least one second recess 112p is similarly in the form of two recesses formed on opposite sides of the cutting element channel <NUM>.

The recesses 112d, 112p formed in the cartridge <NUM> can have a variety of different configurations. In the illustrated example, as shown in <FIG>, each of the recesses is a discrete recess that has a generally circular top cross-section such that the recess is cylindrical. It should be appreciated, however, that the recesses in the end effector's jaw, such as the cartridge, can have other configurations. For example, the recesses can be square, rectangular, semi-circular (e.g., having a semi-circular or oval shape as viewed from the top), and/or they can have any other suitable regular or irregular shapes. Regardless of their specific configuration(s), the recesses formed in the cartridge are configured to receive therein at least a portion of a respective projection formed on an adjunct material or another member, as discussed below.

As shown in <FIG>, the adjunct material <NUM> has projections that are complementary to the recesses 112d, 112p formed in the cartridge <NUM> and that are configured to mate with the recesses 112d, 112p to retain the adjunct material <NUM> on the cartridge <NUM>. In the illustrated embodiments, the adjunct material's projection(s) are disposed at least at proximal and distal ends of the adjunct material. In particular, as shown in <FIG>, the adjunct material <NUM> has at least one first projection 116d formed at the distal end 106d thereof and at least one second projection 116p formed at the proximal end 106p thereof. In the example illustrated, where some of the projections are obscured, the at least one first projection 116d and the at least one second projection 116p are each in the form of two respective projections.

The adjunct material <NUM> can be formed from any suitable material or a combination of materials, which are discussed above. In some embodiments, the adjunct material <NUM> can have a thickness from about <NUM> inches to about <NUM> inches (about <NUM> to about <NUM>). In some embodiments, the adjunct material <NUM> can have a thickness from about <NUM> inches to about <NUM> inches (about <NUM> to about <NUM>). The projections 116d, 116p can have a height or thickness from about <NUM> to about <NUM> inches (about <NUM> to about <NUM>). In some embodiments, the projections, which can be formed from an elastomeric material, can have a height in a range from about <NUM> inches to about <NUM> inches (about <NUM> to about <NUM>), in a range from about <NUM> inches to about <NUM> inches (about <NUM> to about <NUM>), or a height that varies in other ranges. However, in some embodiments, the projections 116d, 116p can have a height or thickness up to about <NUM> inches (<NUM>) or greater.

The locations of the first projections 116d and the second projections 116p formed on the adjunct material <NUM> correspond to the locations of the first recesses 112d and the second recesses 112p formed on the cartridge <NUM>, respectively. However, in some embodiments, as discussed below, the first distal projections 116d can be closer to one another than the first distal recesses 112d, and similarly the second proximal projections 116p can be closer to one another than the second proximal recesses 112d. Furthermore, the configuration and size of the projections 116d, 116p corresponds to those of the recesses 112d, 112p. In this way, the projections 116d, 116p can be caused to be at least partially received within the recesses 112d, 112p, respectively.

For example, as shown in <FIG>, the projections 116d, 116p configured to be at least partially received in the recesses 112d, 112p are complementary in shape to the recesses such that the projections 116d, 116p each have a generally circular top cross-section and are generally cylindrical. Furthermore, in the example of <FIG>, the projections 116d, 116p are formed in the adjunct material <NUM> such they have an open-end channel extending least partially therethrough that opens on a side <NUM> of the adjunct material <NUM> opposed to its side facing the cartridge <NUM>. For example, the projection 116d, which can represent all of the projections formed on the adjunct material <NUM>, is shown to have a channel <NUM> extending therethrough. The channel <NUM> can be formed through the entire projection or through a portion thereof such that a recess can be formed on the side <NUM>. Moreover, in some implementations, the projections 116d, 116p formed in the adjunct material <NUM> may not have a channel extending at least partially therethrough.

As mentioned above, in addition to the adjunct material <NUM>, the end effector <NUM> of the illustrated implementation includes the polymer attachment layer <NUM> used in conjunction with the adjunct material <NUM>. In particular, the polymer attachment layer <NUM> is disposed between the cartridge <NUM> and the adjunct material <NUM>, as shown in <FIG> and <FIG>. The polymer attachment layer <NUM>, which can be made from a pressure-sensitive adhesive or other suitable material, is used as an attachment or retaining feature. For example, non-limiting examples of materials can include materials described in <CIT>. The polymer attachment layer <NUM> is configured to hold the adjunct material <NUM> in a releasable engagement with the cartridge <NUM>. Also, the polymer attachment layer <NUM> can provide additional reinforcement to a treatment site. The polymer material <NUM> can have a size that is the same or approximately the same to that of the adjunct material <NUM> such the entire surface of the adjunct material <NUM> is disposed on the polymer material <NUM>. The polymer layer may also serve as a reservoir for medicants such as antimicrobials, chemotherapeutic agents, etc. or be radiopaque for imaging purposes.

As shown in <FIG>, the polymer attachment layer <NUM> includes distal and proximal projections 117d, 117p facing the cartridge <NUM>. <FIG> also illustrates that the distal and proximal projections 117d, 117p are formed on the polymer material <NUM> at locations corresponding to the locations of the adjunct's projections 116d, 116p, respectively. Thus, the distal projections 117d can be spaced from the proximal projections 117p along a longitudinal axis A1 of the polymer attachment layer <NUM> by the same distance by which the distal projections 116d are spaced from the proximal projections 116p. The projections 117d, 117p can be configured similarly to the adjunct's projections 116d, 116p - for example, the projections 117d, 117p can each optionally have an open-end channel extending least partially therethrough (not shown).

Also, the distal and proximal projections 117d, 117p of the polymer attachment layer <NUM> can have a length or diameter, as measured along the longitudinal axis A1, that is similar to that of a length or diameter of the distal and proximal projections 116d, 116p of the adjunct material <NUM>. In some embodiments, the polymer attachment layer <NUM> can have a thickness from about <NUM> inches to about <NUM> inches (about <NUM> to about <NUM>). The projections 117d, 117p can have a height or thickness from about <NUM> to about <NUM> inches (about <NUM> to about <NUM>). In some embodiments, the projections, which can be formed from an elastomeric material, can have a height in a range from about <NUM> inches to about <NUM> inches (about <NUM> to about <NUM>), in a range from about <NUM> inches to about <NUM> inches (about <NUM> to about <NUM>), or a height that varies in other ranges. However, in some embodiments, the projections 116d, 116p can have a height or thickness up to about <NUM> inches (<NUM>) or greater.

The polymer attachment layer <NUM> can be formed from any suitable material such as, for example, polydioxanone (PDO), PLA/PGA copolymers, or any other suitable polymeric material(s), including pressure sensitive adhesive(s). Thus, the adjunct material <NUM> can be releasably engaged with the cartridge <NUM> via the polymer attachment layer <NUM>. The polymer layer's projections 117d, 117p can be formed from the same material as the rest of the polymer attachment layer <NUM>. Also, in some embodiments, the distal and proximal projections 117d, 117p can be formed from a different material than the material forming the polymer attachment layer <NUM>. Because the material forming the polymer attachment layer <NUM> is biodegradable and/or bioabsorbable, the polymer attachment layer <NUM> can be implanted to a treatment site together with the adjunct <NUM>.

As mentioned above, the end effector <NUM> can be removably coupled with the loading member <NUM> having distal and proximal projections 115d, 115p and configured to apply force to the adjunct material <NUM> to thereby cause the adjunct material <NUM> to mate with the end effector <NUM>. In particular, the application of force by the loading member <NUM> (and thus by the distal and proximal projections 115d, 115p thereof) to the adjunct material <NUM> causes the adjunct material's projections 116d, 116p to be at least partially received in the recesses 112d, 112p of the cartridge <NUM>. Also, in embodiments such as in the example illustrated in which the polymer attachment layer <NUM> is disposed between the adjunct material <NUM> and the tissue-facing surface <NUM> of the cartridge <NUM>, the application of force by the loading member <NUM> to the adjunct material <NUM> and thus to the polymer attachment layer <NUM> causes the polymer layer's projections 117d, 117p to be at least partially received in the recesses 112d, 112p of the cartridge <NUM>. Furthermore, the adjunct material's projections 116d, 116p can be caused to be at least partially received within the polymer layer's projections 117d, 117p, respectively, as discussed below.

The distal and proximal projections 115d, 115p of the loading member <NUM>, each of which can be in the form of two respective projections, can be configured in a number of different ways. For example, the distal and proximal projections 115d, 115p can have a length (measured along a longitudinal axis A2 of the loading member <NUM>) that is similar to that of the adjunct material's projections 116d, 116p and the polymer layer's projections 117d, 117p. The distal and proximal projections 115d, 115p can have an open-end channel extending least partially therethrough and opening on a side of the loading member <NUM> facing the anvil <NUM>, as shown in <FIG>. However, in some implementations, one or more of the projections 115d, 115p may not include such channel.

Also, the distal and proximal projections 115d, 115p of the loading member <NUM> can be spaced apart from one another along the longitudinal axis A2 by approximately the same distance as the adjunct material's projections 116d, 116p and the polymer layer's projections 117d, 117p. In some embodiments, however, the distal and proximal projections 115d, 115p of the loading member <NUM> can be configured and/or formed on the loading member <NUM> in a different way. Furthermore, in some implementations, the loading member <NUM> may not include the distal and proximal projections 115d, 115p, or the loading member <NUM> may include only one projection, or other number (e.g., more than two) projections of any suitable configurations.

The loading member <NUM> can have a variety of different configurations. For example, the loading member <NUM> can be in the form of an applicator or retainer that can be removably coupled to the end effector <NUM>. For example, in the illustrated implementation, as shown in <FIG> and <FIG>, the member <NUM> is an elongate, generally rectangular component having a length and width generally corresponding to the length and width of the tissue-contacting surface of the cartridge <NUM>. The member <NUM> also has a distal tongue portion <NUM> in the form of a downward bent and a generally flat portion extending distally from the bend. The distal tongue portion <NUM> can facilitate grip and can serve as a lever. In use, the surgeon can hold the distal tongue portion <NUM> and apply force thereto in the direction towards the tissue-facing surface <NUM> of the cartridge <NUM> to thereby cause the member <NUM> to apply load to the adjunct material <NUM>. The distal tongue portion <NUM> can be grasped and moved (e.g., moved away from the cartridge body <NUM>) to remove the loading member <NUM> from the end effector <NUM>.

Additionally or alternatively, the loading member <NUM> can be "preloaded," or releasably coupled with, the adjunct material <NUM> and the polymer attachment layer <NUM> in a suitable manner. When force is applied to the adjunct material <NUM>, either by operating the loading member <NUM>, or when the loading member <NUM> is clamped between the cartridge and anvil <NUM>, <NUM>, the adjunct material <NUM>, and the polymer attachment layer <NUM> (if present) are transferred to the cartridge <NUM>. The loading member <NUM> can then be removed from the end effector <NUM>.

The loading member <NUM> can be coupled to the end effector <NUM> in many different ways. In the illustrated example, the loading member <NUM> is coupled to the proximal end 102p of the cartridge <NUM> using one or more suitable features. For example, the loading member <NUM> can have at a proximal end 105p thereof a tab <NUM> (<FIG>) configured to engage the proximal end 102p of the cartridge body <NUM>. It should be appreciated, however, that any other suitable feature(s) can be used to removably couple the member <NUM> to the cartridge body <NUM>. Furthermore, in some implementations, the loading member <NUM> may not be coupled to the end effector <NUM> - e.g., as discussed above it can be clamped between the end effector's jaws to thereby cause the adjunct material <NUM> (and the polymer attachment layer <NUM>, if present) to be transferred to the cartridge <NUM>.

In some embodiments, the adjunct material <NUM> and the polymer attachment layer <NUM> can be coupled to the loading member <NUM> in a suitable manner before the adjunct material <NUM> and the polymer attachment layer <NUM> are delivered to the cartridge body <NUM>. Regardless of its configuration and the way in which it is used to cause the adjunct material to be releasably retained on a jaw of an end effector (e.g., the cartridge <NUM>), the loading member <NUM> is configured to evenly apply force to the surface of the adjunct material <NUM> such that the adjunct material <NUM> becomes attached to the jaw.

In some embodiments, as mentioned above, projections of the adjunct material can be at least partially received within the projections the polymer layer. <FIG> demonstrate such an example where first and second projections 216a, 216b of an adjunct material <NUM> are at least partially received within first and second projections 217a, 217b of a polymer layer <NUM>. The adjunct material <NUM> and the polymer layer <NUM> can be similar, for example, to the adjunct material and polymer layer <NUM>, <NUM> (<FIG> and <FIG>), respectively. It should be appreciated that. while <FIG> and <FIG> illustrate the adjunct material's and polymer layer's distal and proximal projections, <FIG> and 8C show, by way of example, only respective pairs of distal projections formed on the adjunct material <NUM> and the polymer layer <NUM>. Thus, for example, the first and second projections 216a, 216b of the adjunct material <NUM> can be similar to the at least one distal projection 116d of the adjunct material <NUM> in <FIG>. It should be appreciated that the adjunct material <NUM> and the polymer layer <NUM> can also have respective proximal projections, similar, for example, to the at least one proximal projection 116p and at least one proximal projection 117p (<FIG>), respectively.

As shown in <FIG>, the first and second projections 216a, 216b of the adjunct material <NUM> extend from the top into the first and second projections 217a, 217b of the polymer layer <NUM>. The adjunct material <NUM> and the polymer layer <NUM> can be mated in this way in a number of different ways. For example, the adjunct material <NUM> can be preloaded with the polymer layer <NUM>. Alternatively, the projections of the adjunct material <NUM> can be mated with the projections of the polymer layer <NUM> using the loading member or other component(s) configured to apply force to the adjunct material.

Regardless of the way in which the adjunct material <NUM> is mated with the polymer layer <NUM> so as to result in the structure as shown in <FIG>, such adjunct material/polymer layer structure can be caused (e.g., using the loading member <NUM> or another suitable component) to be engaged with the jaw of an end effector. For example, <FIG> illustrates that force can be applied (shown by arrow <NUM>) to the adjunct material <NUM> mated with the polymer layer <NUM> to cause the first and second projections 217a, 217b of polymer layer <NUM> (and thus the first and second projections 216a, 216b of the adjunct material <NUM> mated therewith) to be engaged with corresponding first and second recesses 212a, 212b formed in a jaw <NUM>. The jaw <NUM> can be a cartridge body (e.g., cartridge body <NUM> in <FIG> and <FIG>). However, the jaw <NUM> can also be an anvil, as the described techniques can be used to releasably retain an adjunct material on an anvil of the end effector as well.

A distance between the first and second recesses 212a, 212b formed in the jaw <NUM> can be greater than a distance between the first and second projections 217a, 217b of polymer layer <NUM> (and thus between the first and second projections 216a, 216b of the adjunct material <NUM>), prior to mating the polymer layer <NUM> and the adjunct material <NUM> with the jaw <NUM>. As a result of the force applied to the adjunct material <NUM> mated with the polymer layer <NUM>, a distance between the first and second projections 217a, 217b (and thus between the first and second projections 216a, 216b) can increase, as shown in <FIG> by arrows <NUM>. In this way, as the force is applied to the adjunct material <NUM> and its thickness thus decreases, the projections of the polymer layer <NUM> and of the adjunct material <NUM> "find" the first and second recesses 212a, 212b formed in the jaw <NUM> to thereby releasably mate the adjunct material <NUM> with the jaw <NUM>.

Projections formed on an adjunct material in accordance with the described embodiments can have various configurations. For example, in some embodiments, the projections can be longitudinal projections formed on opposed sides of the adjunct material. The longitudinal projections formed on the adjunct material can be configured to be mated with complementary features (e.g., recesses) formed on a jaw of an end effector.

<FIG> illustrate an embodiment of an end effector <NUM> having a cartridge <NUM> and an anvil <NUM>, at least one of which can be configured to be releasably mated with an adjunct material having longitudinal projections. As shown in <FIG>, the cartridge <NUM> has a plurality of staple cavities <NUM> configured to seat staples therein, the staple cavities formed on a tissue-facing surface <NUM> of the cartridge <NUM>. The anvil <NUM> of the end effector <NUM>, shown in <FIG>, has a plurality of staple forming cavities (not shown) formed on a tissue-facing surface <NUM> thereof.

In the illustrated implementation, the end effector <NUM> can have an adjunct material releasably retained on one or both of the jaws <NUM>, <NUM>. Thus, as shown in <FIG>, an adjunct material <NUM> can be releasably mated with the cartridge <NUM>. The adjunct material <NUM> has a first longitudinal projection 316a formed on one side 315a of the adjunct material <NUM> and a second longitudinal projection 316b formed on another, opposite side 315b of the adjunct material <NUM>. As shown, the first and second longitudinal projections 316a, 316b extend between distal and proximal ends 306d, 306p of the adjunct material <NUM>.

The first and second longitudinal projections 316a, 316b of the adjunct material <NUM> are configured to mate with respective first and second complementary recesses 312a, 312b formed in the tissue-facing surface <NUM> of the cartridge <NUM>. As shown in <FIG>, the first and second longitudinal recesses 312a, 312b extend along a longitudinal axis A3 of the cartridge <NUM>, are formed on opposed sides of a cutting element channel <NUM>, and are each adjacent to opposed sides 311a, 311b of the tissue-facing surface <NUM>.

The longitudinal projections 316a, 316b formed on the adjunct material <NUM> can have a number of different configurations. For example, the first and second longitudinal projections 316a, 316b of the adjunct material <NUM> have mating features 318a, 318b formed thereon that are configured to be at received within the corresponding recesses 312a, 312b. In this example, the mating features 318a, 318b are in the form of arrows facing towards the recesses 312a, 312b formed in the cartridge <NUM>.

The longitudinal projections 316a, 316b can be formed from at least partially flexible and/or deformable material such that, as the projections 316a, 316b are received within the corresponding recesses 312a, 312b, the projections 316a, 316b contract to fit into the recesses and, once in the recesses, expand to be fittingly received within the recesses. Thus, the arrow-shaped mating features 318a, 318b extending from the adjunct material's longitudinal projections 316a, 316b can have a width that is greater than that of the respective recesses 312a, 312b. When the mating features 318a, 318b are forced into the recesses 312a, 312b, they can first be caused to contract as they are forced into the recesses, where they then expand to be releasably retained therein. It should be appreciated that the arrow-shaped mating features 318a, 318b are shown by way of example only, and the mating features formed on the projections can have any suitable configuration. For example, the mating features can be C-shaped, J-shaped, or they can have any other configuration(s), including different configurations.

As shown in <FIG>, an adjunct material <NUM> configured to be releasably retained on the anvil <NUM> can have first and second longitudinal projections 322a, 322b, which can be similar to the longitudinal projections 316a, 316b formed on the adjunct material <NUM> configured to be releasably retained on the cartridge <NUM>. For example, similar to the cartridge <NUM>, the anvil <NUM> can have longitudinal recesses formed therein that are configured to receive therein the longitudinal projections 322a, 322b.

One or both of the adjunct materials <NUM>, <NUM> can be releasably retained on the jaws <NUM>, <NUM>, respectively, using an applicator member <NUM> shown in <FIG>. The applicator member <NUM> can be in the form of a frame-like holder configured to releasably retain one or both of the adjunct materials <NUM>, <NUM>. In the illustrated example, the applicator member <NUM> is in the form of first (e.g., bottom) and second (e.g., top) generally rectangular housings <NUM>, <NUM> coupled to one another as shown in <FIG>. As also shown in <FIG>, the first and second housing <NUM>, <NUM> can encompass edges of the long sides of the adjunct materials <NUM>, <NUM> disposed within the applicator member <NUM>. In other words, the applicator member <NUM> can be in the shape of a generally rectangular frame following an outer perimeter of at least two sides (e.g., long sides) of one or two adjunct materials. In particular, as shown in <FIG>, the applicator member <NUM> encompasses at least in part the portions of the adjunct materials <NUM>, <NUM> having first and second longitudinal projections 316a, 316b, and 322a, 322b, respectively, extending therefrom. The rest of the surface area of the adjunct materials <NUM>, <NUM> may be not encompassed by the applicator member <NUM>, as shown in <FIG>. The adjunct material <NUM> to be retained on the anvil is disposed over the adjunct material <NUM> to be retained on the cartridge. It should be appreciated that the adjunct materials <NUM>, <NUM> and the first and second housings <NUM>, <NUM> of the applicator member <NUM> encompassing them can be symmetrical. Thus, either of the adjunct materials <NUM>, <NUM> can be applied to the anvil or the cartridge.

The applicator member <NUM> can be formed from any suitable material (e.g., plastic), and its walls can be relatively thin and it can be disposable. In use, to transfer the adjunct materials <NUM>, <NUM> to the cartridge and anvil <NUM>, <NUM>, respectively, the cartridge and anvil <NUM>, <NUM> can be clamped over the applicator member <NUM>. In this way, force applied by the jaws <NUM>, <NUM> causes the adjunct materials <NUM>, <NUM> to separate from the applicator member <NUM> and to be engaged with the jaws <NUM>, <NUM>. In particular, in this example, as force is applied to the applicator member <NUM> by the jaws <NUM>, <NUM> of the end effector <NUM>, the longitudinal projections 316a, 316b formed in the adjunct material <NUM> mate with the recesses 312a, 312b in the cartridge <NUM>, and, similarly, the longitudinal projections 322a, 322b formed in the adjunct material <NUM> mate with the complementary recesses (not shown) in the anvil <NUM>.

After the adjunct materials <NUM>, <NUM> are transferred to the cartridge and anvil <NUM>, <NUM>, the cartridge and anvil <NUM>, <NUM> can be opened and the applicator member <NUM> can be separated from the end effector <NUM>. The end effector <NUM> having its cartridge and anvil <NUM>, <NUM> thus mated with the adjunct materials <NUM>, <NUM>, as shown in <FIG>, can then be used as desired in a surgical procedure.

It should be appreciated that the applicator member <NUM> is shown to releasably retain both of the adjunct materials <NUM>, <NUM> by way of example only, as the applicator member <NUM> or a similar component configured to releasably hold at least one adjunct material can be used to transfer an adjunct material only to an end effector's anvil or an end effector's cartridge.

In some embodiments, at least one projection formed on the adjunct material can be in the form of a plurality of discrete projections formed from an at least partially flowable or bendable material that has a changeable configuration. When a suitable applicator applies force to the adjunct material to cause each of the discrete projections to be at least partially received within a corresponding recess in a jaw of an end effector, the configuration of each of the discrete projections that is at least partially received within the corresponding recess changes to conform to a configuration of the corresponding recess. The discrete projections are configured to separate from the adjunct material and remain within the recesses in the jaw after the staples are formed against the staple forming cavities to apply the adjunct material to a tissue clamped between the end effector's jaws.

<FIG> illustrate another example of an end effector <NUM> having a cartridge <NUM> and an anvil <NUM>, at least one of which can have an adjunct material releasably retained thereon that is has projections made from an at least partially flowable material. The projections can also be formed from at least partially bendable, free-flowing, or waxy materials. In other words, the material from which the projections are formed can be deformable in various ways. For example, they can be made from polymers/elastomers may deform or bend and still retain memory of their original shape.

In this example, as shown in <FIG>, both the cartridge <NUM> and the anvil <NUM> can have respective adjunct materials <NUM>, <NUM> to be releasably retained thereon. As shown in <FIG>, the adjunct material <NUM> releasably retained on a tissue-facing surface <NUM> of the cartridge <NUM> has a plurality of discrete projections <NUM> configured to be releasably mated with recesses <NUM> formed in the tissue-facing surface <NUM>. As shown in <FIG>, the discrete projections <NUM> are formed along a longitudinal axis A4 of the adjunct <NUM>. It should be appreciated that the projections <NUM> and recesses <NUM> do not need to be evenly spaced and, in some embodiments, they can be disposed at varied distances from one another. The locations and number of the projections <NUM> and recesses <NUM> can be selected based on a desired manner of attaching the adjunct material to the end effector's jaw. Accordingly, the seven evenly spaced projections <NUM> are shown in <FIG> by way of example only, as suitable number of projections can be formed, and the projections can be formed asymmetrically and unevenly spaced with respect to one another.

The adjunct material <NUM> releasably retained on a tissue-facing surface <NUM> of the anvil <NUM> also has a plurality of discrete projections <NUM> configured to be releasably mated with recesses <NUM> formed in the tissue-facing surface <NUM>. It should be appreciated that each of the discrete projections <NUM>, <NUM> can be formed such that it spans the entirety of, or only a portion of, the width of the respective jaw. Also, in some implementations, each of the discrete projections <NUM>, <NUM> can be in the form of two projections formed on opposed sides of the tissue-facing surface of the jaw, although only one of such projections is shown in <FIG>.

In this example, the discrete projections <NUM> formed on the adjunct material <NUM> and the discrete projections <NUM> formed on the adjunct material <NUM> have a generally rectangular shape, as shown in <FIG> (where the projections of the anvil's adjunct material <NUM> are shown partially separated from the anvil <NUM>). The discrete projections <NUM>, <NUM> can be formed from an at least partially flowable material and can have a changeable configuration such that, when each of the discrete projections is at least partially received within a corresponding recess in the jaw, the configuration of each discrete projection changes to conform to a configuration of the corresponding recess. The at least partially flowable material can be any suitable material or a combination of materials. Examples of the materials can include a suitable polymeric material, elastomeric material (e.g., silicone), wax, and any other material(s). For example, collagen, gelatin hyaluronic acid, sodium alginate, or any other hydrogels can be used. Also, non-limiting examples of materials can include materials described in <CIT>.

In some embodiments, a more rigid polymer/elastomer can be used that can be perforated/slitted at the end, such that it frays outward into a T-slot pocket, rather than deforming in bulk, which would require a material with very low shear-resistance. In some embodiments, a material from which the adjunct is formed can be used to fill out the recess on its own. This may be possible with non-woven fabrics having fibers that areable to slide/shear relative to each other.

Accordingly, in the illustrated implementation, each of the generally rectangular projections <NUM> formed on the adjunct material <NUM> to be releasably retained on the anvil <NUM>, "flows" into, or conforms, to the configuration of each of the recesses <NUM>, as shown in <FIG>. As also shown in <FIG>, the projections <NUM> of the adjunct <NUM> (which can also be generally rectangular projections) "flow" into the T-shaped recesses <NUM> formed in the cartridge <NUM> to thus conform to the shape of the recesses <NUM>.

The adjunct materials <NUM>, <NUM> can be transferred to the cartridge and anvil <NUM>, <NUM> using an applicator member <NUM> shown in <FIG>, which can be similar to applicator member <NUM> (<FIG>). Thus, as shown in <FIG>, the applicator member <NUM> can be a frame-like holder having first and second portions <NUM>, <NUM> releasably holding the adjunct materials <NUM>, <NUM>. To transfer the adjunct materials <NUM>, <NUM> from the applicator member <NUM> to the end effector <NUM>, the jaws <NUM>, <NUM> can be clamped upon the applicator member <NUM>, which causes the adjunct materials <NUM>, <NUM> to be mated with the cartridge and anvil <NUM>, <NUM>, respectively. In particular, as discussed above, the projections, on the adjunct materials <NUM>, <NUM> are received in the recesses <NUM>, <NUM> in the cartridge and anvil <NUM>, <NUM> so that the projections (which are formed from at least partially flowable material) change their configuration to fill in the recesses and thus adopt the shape of the recesses. Similar to the applicator member <NUM> (<FIG>), after the applicator member <NUM> is used to transfer the adjunct materials <NUM>, <NUM> to the end effector's jaws, the applicator member <NUM> can be separated from the end effector <NUM>.

During a surgical procedure, as shown in <FIG>, a tissue T is clamped between the cartridge <NUM> and anvil <NUM> of the end effector <NUM> and staples <NUM> are formed against the staple forming cavities of the anvil <NUM>. The ejection of the staples from the staple-holding cavities opening on the tissue-facing surface <NUM> of the cartridge <NUM> causes the adjunct materials <NUM>, <NUM> to be released from engagement with the cartridge <NUM> and anvil <NUM> and to be applied to opposed sides of the tissue T, as also shown in <FIG>. As further shown in <FIG>, the discrete projections <NUM>, <NUM> separate from the adjunct materials <NUM>, <NUM> applied to the tissue T and remain within the recesses <NUM>, <NUM>, respectively. Such embodiments can be employed in implementations where, for example, the end effector <NUM> is part of a disposable loading unit configured to be coupled distally to a surgical tool and that is configured to be disposed after use.

In some embodiments, an adjunct material configured to be releasably retained on a jaw of an end effector can be formed from at least partially expandable or stretchable material and/or in the form of a film. The jaw, such as an anvil or a cartridge, can have one or more recesses formed therein that are configured to receive portions of the adjunct material. An applicator member, such as, e.g., loading member <NUM> in <FIG>, applicator member <NUM> in <FIG>, or a member having any other configuration that has projections formed thereon, can be used to mate the adjunct material with the jaw. For example, when the applicator member is used to apply force to the adjunct material, the projections formed on the applicator member cause portions of the adjunct material to be releasably received within the one or more recesses formed in the jaw.

<FIG> illustrate one example of an implementation of an adjunct material <NUM> configured to be mated with a jaw <NUM> of an end effector of a surgical instrument. In this example, the jaw <NUM> is shown generally as a jaw that can be either a cartridge or an anvil. Regardless of its particular configuration, the jaw <NUM> can have recesses <NUM> formed in a tissue-facing surface <NUM> thereof. It should be appreciated that the recesses <NUM> can be formed at any locations within tissue-facing surface <NUM>. Also, the six recesses <NUM> are shown in <FIG> for illustrating purposes only, as any suitable number of recesses <NUM> (e.g., less than six or greater than six) can be formed on the jaw. Also, the recesses <NUM> do not need to be evenly spaced and, in some embodiments, they can be disposed at varied distances from one another. The locations and number of the recesses <NUM> can be selected based on a desired manner of attaching the adjunct material to the end effector's jaw.

For example, the recesses <NUM> can be formed in the area of the tissue-facing surface <NUM> occupied by staple-forming cavities (if the jaw <NUM> is an anvil) or by staple-holding cavities or pockets (if the jaw <NUM> is a cartridge). As another example, one or more of the recesses <NUM> can be formed in area(s) of the tissue-facing surface <NUM> that does not have the staple-forming cavities or the staple-holding pockets. For example, in one embodiment, one or more recesses can be formed at a distal end of the jaw <NUM> outside of the area having the staple-forming cavities or the staple-holding pockets, and one or more recesses can be formed at a proximal end of the jaw <NUM> outside of the area having the staple-forming cavities or the staple-holding pockets. Furthermore, in some implementations, one or more of the recesses <NUM> can be the staple-forming cavities or the staple-holding pockets.

The recesses <NUM> are shown by way of example only as having a generally circular cross-section. However, the recesses <NUM> can have other suitable shapes, as the described embodiments are not limited in this respect. One or more of the recesses <NUM> can have features that facilitate their ability to retain a portion of the adjunct material therein. For example, as shown in <FIG>, the recess <NUM> can have retaining features 512a, 512b that can be in the form of hooks, teeth, rings, barbs, or retaining elements having any other configuration. It should be appreciated that one or more of the retaining features can be formed, or the recesses <NUM> can be free of any additional features.

Regardless of the way in which the recesses <NUM> are formed in the jaw <NUM>, each recess (e.g., the recess <NUM> shown in <FIG>) is configured to receive therein a corresponding projection or post <NUM> formed on an applicator member <NUM>. The applicator member <NUM>, having one or more posts (one of which is shown in <FIG>), can have any suitable configuration that enables force to be applied by the applicator member <NUM> to the adjunct material <NUM>. As mentioned above, the adjunct material <NUM> can be formed from an at least partially stretchable material. Thus, as shown in <FIG>, when force is applied by or to the applicator member <NUM> (as shown by arrow <NUM>), the applicator member <NUM> is brought in proximity to the tissue-facing surface <NUM> such that the post <NUM> is at least partially received within the recess <NUM>. As a result, the post <NUM> pushes a portion <NUM> of the adjunct material <NUM> into the recess <NUM>, as also shown in <FIG>. In this example, the retaining features 512a, 512b extending from the inner walls of the recess <NUM> facilitate retention of the portion <NUM> of the adjunct material <NUM> within the recess <NUM>.

Other recesses formed in the jaw <NUM> can similarly receive at least partially therein posts formed on the applicator member <NUM> that thus push portions of the adjunct material <NUM> into the recesses. In this way, the adjunct material <NUM> becomes releasably mated with the jaw <NUM>.

The number and locations of the posts, such as the post <NUM>, formed on the applicator member <NUM> can correspond to those of the recesses <NUM> in the jaw <NUM>. Thus, each of the recesses <NUM> can receive therein a portion of the adjunct material pushed into the recess using a corresponding post. In other implementations, however, only some of the recesses can receive corresponding posts therein.

The post <NUM>, representing just one example of the multiple posts that can extend from the applicator member <NUM>, is shown as a generally cylindrical element by way of example only, as the post <NUM> can have other configurations. For example, the post <NUM> can be mushroom-shaped (e.g., shaped as a "reversed mushroom") or it can have a generally rectangular, square, or otherwise shaped cross-section. The size of the post <NUM> can be selected such that it fits with clearance within the recess <NUM> and pushes the portion <NUM> of the adjunct material <NUM> into the recess <NUM> in a manner that allows retaining that portion <NUM> in the recess <NUM>, as shown in <FIG>. The portion <NUM> can be retained in the recess <NUM> using the retaining features 512a, 512b as shown in <FIG>, or any other type(s) of retaining features.

After the adjunct material <NUM> is mated with the jaw <NUM> using the applicator member <NUM>, the applicator member <NUM> is removed, whereas the adjunct material portion <NUM> remains in the recess <NUM>. When the adjunct material <NUM> is separated from the jaw <NUM> to be transferred to a tissue at a treatment site (e.g., when staples are ejected from the jaw's cartridge), the adjunct material portion <NUM> is caused to exit the recess <NUM>.

In the illustrated example, the adjunct material <NUM>, which can be in the form or a film and/or at least partially stretchable member, can be generally rectangular or it can have other configurations. The size of the adjunct material <NUM> can be such that, when its portions (e.g., the portion <NUM> in <FIG>) are mated with the jaw <NUM>, the adjunct material <NUM> still covers a desired area of the tissue-facing surface <NUM> of the jaw <NUM>. In other words, the adjunct material <NUM> can be oversized relative to a size of the tissue-facing surface <NUM> of the jaw <NUM>. Also, even though some extra material becomes available after the adjunct material's portions are released from the recesses in the jaw, this does not affect the ability of the adjunct material <NUM> to reinforce and/or treat a site in a patient's body.

In some embodiments, an adjunct material can be releasably retained on a jaw of an end effector using a material that can change its configuration when heat is applied thereto. <FIG> illustrate an embodiment of an end effector <NUM> having a cartridge body <NUM> and an anvil <NUM>, which can have an adjunct material <NUM> configured to be retained on at least one of the cartridge body and anvil <NUM>, <NUM> using an attachment layer <NUM>. In particular, in the example illustrated, the attachment layer <NUM> can be used to couple the adjunct material <NUM> to the cartridge body <NUM>, as discussed in more detail below.

As shown in <FIG>, a tissue-facing surface <NUM> of the cartridge body <NUM> can have recesses 612a, 612b disposed outside of the area of the cartridge body <NUM> having staple-holding pockets <NUM>. The two recesses 612a, 612b formed at a distal end 602d of the cartridge body <NUM> are shown, and a proximal end 602p of the cartridge body <NUM> can have a similar pair of recesses. The recesses 612a, 612b are disposed at opposed sides of a cutting-element channel <NUM> in the cartridge body <NUM>, though the recesses 612a, 612b can be disposed at other areas of the tissue-facing surface <NUM> of the cartridge body <NUM>.

As shown in <FIG>, the adjunct material <NUM> can have retaining features 616a, 616b formed at a distal end 606d thereof, and similar retaining features 616c, 616d formed at a proximal end 606p thereof. In the illustrated implementation, the retaining features 616a, 616b, 616c, 616d are in the form of cupcake-like depressions in the adjunct material <NUM> extending towards the cartridge body <NUM> and opening on a side of the adjunct material <NUM> opposite to its side facing the cartridge body <NUM>. It should be appreciated, however, that the retaining features 616a, 616b, 616c, 616d can have any other shapes, and that the number of the retaining features can be different from four (e.g., less than four or greater than four). Furthermore, as in the example illustrated, the retaining features 616a, 616b, 616c, 616d can be formed as closed depressions in the adjunct material <NUM>, or they can be open-ended features opening into the cartridge's recesses when the adjunct is mated therewith.

The distal retaining features 616a, 616b are configured to be received within the distal recesses 612a, 612b in the cartridge body <NUM>. In a similar manner, the proximal retaining features 616c, 616d of the adjunct material <NUM> are configured to be received within the proximal recesses formed in the cartridge body <NUM>, which are obscured in <FIG>.

The attachment layer <NUM>, which can be formed from a suitable heat meltable material, can be used to attach the adjunct material <NUM> to the cartridge body <NUM>. For example, to releasably attach the adjunct material <NUM> to the cartridge body <NUM>, the adjunct material <NUM>, which can have the attachment layer <NUM> coupled thereto in a suitable manner, can be disposed on the tissue-facing surface <NUM> of the cartridge body <NUM>. The attachment layer <NUM> can be coupled to the adjunct material <NUM> or it can be disposed over the adjunct material <NUM> such that the adjunct material <NUM> is located between the tissue-facing surface <NUM> of the cartridge body <NUM> and the attachment layer <NUM>. Regardless of the way in which the attachment layer <NUM> is associated with the adjunct material <NUM>, the adjunct material <NUM> is disposed over the cartridge body <NUM> such that the retaining features 616a, 616b, 616c, 616d are received within the respective recesses formed in the cartridge body <NUM>. For example, the retaining features 616a, 616b are received within the recesses 612a, 612b.

A suitable device can then be used to apply heat to the attachment layer <NUM> such that at least some of its portions melt and the attachment layer's material flows into the retaining features 616a, 616b, 616c, 616d in the adjunct material <NUM> that, in turn, at least partially seat within respective recesses formed in the cartridge body <NUM>. In this way, the material of the attachment layer <NUM> deposited within each of the retaining features 616a, 616b, 616c, 616d of the adjunct material <NUM> mates the adjunct material <NUM> with the cartridge body <NUM>. <FIG> illustrates by way of example a recess <NUM>' in the cartridge body <NUM>, which can be representative of any of the recesses (e.g., 612a, 612b or others) that can be formed in the cartridge body <NUM>. As shown in <FIG>, the recess <NUM>' can seat therein a respective retaining feature <NUM>' (e.g., any of the retaining features 616a, 616b, 616c, 616d) that in turn, is lined with the material of the attachment layer <NUM>.

The attachment layer <NUM> can be formed from any suitable bioabsorbable and/or biodegradable material. Non-limiting examples of the material include polydioxanone (PDO), lactide/glycolide copolymers, poly-L-lactide, poly-L-lactide-co-D,L-lactide, poly-L-lactide-co-glycolide, poly-<NUM>-hydroxybutrate, polycaprolactone, poly lactide-co-glycolide), Poly-L-lactide. Exemplary materials are also disclosed in <CIT>, entitled "Compressible Adjunct Assemblies with Attachment Layers" and <NUM>/<NUM>,<NUM>, entitled "Implantable Adjunct Comprising Bonded Layers.

Heat of a suitable temperature such as, for example, between 80C° and 120C°, can be applied to the end effector <NUM> in any of various ways. Though, other ranges can be used as well, including higher temperatures. For example, a suitable heater device (e.g., an infrared (IR) heater, ultraviolet (UV) heater, resistive heater, etc.) can be used.

In some implementations, the adjunct material <NUM> and the attachment layer <NUM> can be coupled to the jaw of the end effector <NUM>, such as the cartridge body <NUM>, using an applicator member (not shown) configured to apply the adjunct material <NUM> with the attachment layer <NUM> to an end effector's jaw. The applicator member can be similar, e.g., to the applicator member <NUM> (<FIG>), but can also be equipped with a heating element (e.g., a resistive wire element, UV element, IR element, etc.). Similar to the applicator member <NUM>, the heat-applying applicator member can releasably hold the adjunct material <NUM> and the attachment layer <NUM>. Regardless of the specific way in which the applicator member is configured to generate heat, in use, the applicator member can be clamped between the jaws <NUM>, <NUM> of the end effector <NUM> and activated to generate heat to thus melt at least portions of the attachment layer <NUM>. After the attachment layer <NUM> is received within the retaining features of the adjunct material <NUM> (e.g., as shown in <FIG>), the jaws <NUM>, <NUM> can be open and the applicator member can be separated from the end effector <NUM> while leaving the adjunct material <NUM> and the attachment layer <NUM> mated with the end effector <NUM> (in this example, with the cartridge body <NUM>).

It should be appreciated that, additionally or alternatively, an adjunct material can be configured to be releasably mated with an anvil in a manner similar to that shown in <FIG>.

In the embodiments described herein, an adjunct material for use with an end effector of a surgical instrument is provided that has at least one projection configured to mate with a corresponding at least one recess formed in the end effector. However, in other embodiments, an adjunct material can be releasably retained on a jaw of an end effector using recesses formed in the adjunct material that are configured to mate with corresponding projections formed on the jaw.

<FIG> illustrate an embodiment of an end effector <NUM> having a cartridge <NUM> and an anvil <NUM>, at least one of which can be configured to be releasably mated with an adjunct material having longitudinal channels or recesses. In this embodiment, the end effector <NUM> has a cartridge <NUM> and an anvil <NUM> having any suitable configurations, at least one of which can be configured to be releasably mated with an adjunct material having longitudinal recesses. For example, as shown, the end effector <NUM> can have adjunct materials releasably retained on both of the jaws <NUM>, <NUM>. Thus, as shown in <FIG>, an adjunct material <NUM> can be releasably mated with the cartridge <NUM>. The adjunct material <NUM> has a first longitudinal recess 717a formed on one side of the adjunct material <NUM> and a second longitudinal recess 717b formed on another, opposite side of the adjunct material <NUM>. As shown, the first and second longitudinal recesses 717a, <NUM> extend between distal and proximal ends 706d, 706p of the adjunct material <NUM>.

The first and second longitudinal recesses 717a, 717b of the adjunct material <NUM> are configured to mate with respective first and second complementary projections 715a, 715b formed on a tissue-facing surface <NUM> of the cartridge <NUM>. The projections 715a, 715b can have mating features 718a, 718b formed thereon that are configured to mate with the corresponding recesses 717a, 717b in the adjunct material <NUM>. In this example, the mating features 718a, 718b are in the form of arrows facing towards the adjunct material <NUM>, as shown in <FIG>. It should be appreciated that the arrow-shaped mating features 318a, 318b are shown by way of example only, and the mating features formed on the projections can have any suitable configuration. For example, the mating features can be C-shaped, J-shaped, or they can have any other configuration(s), including different configurations.

The longitudinal recesses 717a, 717b formed in the adjunct material <NUM> can have a number of different configurations. For example, the first and second longitudinal recesses 717a, 717b can have a shape that is complementary to that of the first and second projections 715a, 715b. In this way, as in the example illustrated, at least a portion of each of the first and second longitudinal recesses 717a, 717b can be arrow-shaped. However, the recesses 717a, 717b can have any other suitable configuration(s).

The longitudinal projections 715a, 715b can be formed from at least partially flexible and/or deformable material such that, as the projections 715a, 715b are received within the corresponding recesses 717a, 717b in the adjunct material <NUM>, the projections 715a, 715b are contracted to fit into the recesses and, once in the recesses, are then expanded to be fittingly received within the recesses.

As shown in <FIG>, an adjunct material <NUM> configured to be releasably retained on the anvil <NUM> can also have first and second longitudinal recesses 723a, 723b, which can similar to the longitudinal recesses 717a, 717b formed on the adjunct material <NUM> configured to be releasably retained on the cartridge <NUM>. For example, similar to the cartridge <NUM>, the anvil <NUM> can have longitudinal projections formed therein that are configured to be received within the longitudinal recesses 723a, 723b. Similar to the example shown in <FIG>, one or both of the adjunct materials <NUM>, <NUM> can be releasably retained on the jaws <NUM>, <NUM>, respectively, using an applicator member <NUM> shown in <FIG>. The applicator member <NUM>, which can releasably retain therein the adjunct materials <NUM>, <NUM>, can be similar to the applicator member <NUM> (<FIG>) and is therefore not described in detail herein.

It should be appreciated that the adjunct materials described herein can include one or more medicants which can be releasably incorporated into or associated with adjuncts in many different ways. Also, the adjunct materials can have various other features in addition to the features described herein.

A person skilled in the art will appreciate that the subject matter described herein has application in conventional minimally-invasive and open surgical instrumentation as well application in robotic-assisted surgery.

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, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. 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:
An end effector (<NUM>) for a surgical instrument, comprising:
a first jaw having a cartridge (<NUM>) with a plurality of staple cavities configured to seat staples therein, the staple cavities opening on a tissue-facing surface of the cartridge;
a second jaw opposing the first jaw and having an anvil (<NUM>) with a plurality of staple forming cavities formed on a tissue-facing surface thereof, wherein the first and second jaws are configured to clamp tissue therebetween;
at least one recess (112d, 112p) formed in at least one jaw of the first and second jaws;
an adjunct material (<NUM>) having at least one projection (116d, 116p) configured to mate with the at least one recess to retain the adjunct material on the first jaw, the at least one projection being disposed at least at proximal and distal ends of the adjunct material;
a removable applicator member (<NUM>) configured to apply force to the adjunct material so as to cause the at least one projection of the adjunct to be received in a corresponding recess formed in the first jaw to thereby cause the adjunct material to be releasably mated with the first jaw, wherein the applicator member is configured to releasably hold the adjunct material so as to release the adjunct material when the applicator member is clamped between the first and second jaws;
characterised by a polymer attachment layer (<NUM>) configured to be positioned between the first jaw and the adjunct material, the polymer attachment layer including at least one second projection (117d, 117p) facing the cartridge and formed on the polymer attachment layer at a location thereof corresponding to a location of the at least one projection of the adjunct material.