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, various issues still exist. For example, 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. While these issues can be solved by application of various adjuncts to the tissue, it can be challenging to deliver these solutions to a tissue site and ensure proper placement. It can be desirable to have material securely attached to a surgical stapler during positioning and have material cleanly separate from the surgical stapler during use. Having materials both securely attached to and easily separable from surgical staplers can present problems. Thus there remains a need for improved devices, systems, and methods for attaching adjuncts to and releasing adjuncts from various surgical devices, such as surgical staplers. <CIT> describes a surgical instrument that includes an end effector and a staple cartridge that is insertable into the end effector. The staple cartridge includes a buttress material that is selectively coupled to the staple cartridge. In some versions the buttress material may be stapled to the staple cartridge by one or more attachment staples. Such attachment staples may be inserted into staple apertures formed through an upper deck of the staple cartridge. The attachment staples may include resiliently biased legs to frictionally resist removal. In some versions the attachment staples may be sized to form an interference fit in the staple apertures. Alternatively, the attachment staples may include barbs. A staple driver may be used to decouple the attachment staples. The staple driver may include staple forming pockets to bend the legs of the attachment staple when decoupling the attachment staple. <CIT> describes systems of releasably connecting staple line buttress material to the jaws of a surgical stapling instrument are provided. The systems include retainers configured to engage the buttress material and releasably retain the buttress material on the jaws of the surgical stapling instrument prior to stapling tissue. In certain embodiments, the retainers remain with the jaws of the instrument after stapling of tissue. In alternative embodiments, the retainers remain with the buttress material after being stapled to tissue. <CIT> describes a piece of buttress material and an end-effector of a surgical instrument including features which can aid a surgeon in properly and quickly attaching the piece of buttress material to the end-effector. In various embodiments, a piece of buttress material can include retention features which can be engaged with portions of an end-effector to releasably retain the piece of buttress material to at least a portion of the end-effector. Similarly, an end-effector can include features configured to engage portions of a piece of buttress material to releasably retain the piece of buttress material to the end-effector. In at least one embodiment, more than one piece of buttress material can be releasably retained to an end-effector.

Various methods, devices, and systems are provided for anchoring and releasing adjuncts from an end effector of a surgical device.

In one embodiment, a staple cartridge assembly is provided for use with a surgical stapler that includes a cartridge body with a plurality of staple cavities on a tissue-facing surface thereof. Each staple cavity has a staple disposed therein that is configured to be deployed into tissue, and the cartridge body has a plurality of connection cavities on the tissue-facing surface. An adjunct is disposed on the tissue-facing surface of the cartridge body. A plurality of drivers is disposed within the cartridge body. Each driver has at least one adjunct releasing mechanism located thereon such that the plurality of drivers configured to cause the adjunct to detach from the cartridge body when the plurality of drivers are advanced into the staple cavities staples to deploy the staples.

The assembly can vary in numerous ways. For example, each connection cavity can be configured to receive a portion of the adjunct therein. The adjunct can have protrusions configured to be received in one or more of the plurality of connection cavities and configured to attach the adjunct to the cartridge body. In another example, the at least one adjunct releasing mechanism can include a post configured to extend into one of the plurality of connection cavities. In another example, the post can be configured to extend beyond the tissue-facing surface of the cartridge body to cause the adjunct to detach from the cartridge body. The adjunct can be releasably attached to the tissue-facing surface of the cartridge body with an adhesive. In some embodiments, the adhesive can be cyanoacrylate.

According to the invention, an end effector is provided for use with a surgical stapling instrument that includes a first jaw with a staple cartridge and a plurality of staple cavities configured to seat staples therein. An adjunct is attached to a tissue-facing surface of the cartridge and overlies the plurality of staple cavities. A second jaw has an anvil with a plurality of staple-forming cavities
formed on a tissue-facing surface thereof, and the first and second jaws are configured to clamp the tissue therebetween. A plurality of drivers are disposed within the cartridge and configured to deploy a plurality of staples through the staple cavities, through the adjunct, and into tissue engaged between the first and second jaws, and to simultaneously cause the adjunct to detach from the cartridge.

The end effector can have a number of variations. For example, the adjunct can be attached to the tissue-facing surface of the cartridge by an adhesive. The cartridge can have at least one connection cavity formed in the tissue-facing surface thereof, and the adjunct can have at least one protrusion formed thereon that extends into the at least one connection cavity for attaching the adjunct to the cartridge. In some examples, each of the at least one connection cavities can be configured to receive a portion of one of the plurality of drivers therein. According to the invention, each of the plurality of drivers has a post that is configured to extend beyond the tissue-facing surface of the cartridge to cause the adjunct to detach from the cartridge.

In another aspect, a surgical method can be provided that includes advancing a surgical stapler into a body of a patient. The surgical stapler has an end effector at a distal end thereof with first and second jaws, and an adjunct attached to the first jaw of the end effector. The method includes engaging tissue between the first and second jaws of the end effector. The method also includes actuating the surgical stapler to cause a plurality of drivers to fire staples from the first jaw, through the adjunct, and into the tissue, and to cause the plurality of drivers to detach the adjunct from the first jaw. While this method is not claimed, it may be used with the end effector of the present invention, and is considered useful for understanding the invention.

The method can have numerous variations. For example, actuating the surgical stapler can cause a releasing member on each of the plurality of drivers to enter a connection cavity in a tissue-facing surface of the first jaw. In another example, actuating the surgical stapler can cause the releasing member to push a portion of the adjunct retained in the connection cavity out of the connection cavity to detach the adjunct from the first jaw. Actuating the surgical stapler can also cause the releasing member to engage the adjunct, thereby breaking an adhesive bond between the adjunct and the first to detach the adjunct from the first jaw.

This invention 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. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure.

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.

In some embodiments, the devices and methods described herein are provided for open surgical procedures, and in other embodiments, the devices and methods are provided for laparoscopic, endoscopic, and other minimally invasive surgical procedures. 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.

Various exemplary devices, systems, and methods for releasably retaining an adjunct material on an end effector of a surgical instrument are described herein. In some implementations, an adjunct material can be releasably retained on a jaw of an end effector in a manner that reduces or prevents the adjunct material from prematurely slipping off the jaw. In this way, the adjunct can be securely coupled to the end effector while a surgeon manipulates the end effector during a surgical procedure. The adjunct material can be coupled to an end effector in a variety of ways, for example by inserting portions of the adjunct into connection cavities on a tissue-facing surface of the jaw. In some embodiments, the adjunct can have tags or protrusions that extend from an outward facing surface such that the tags can be configured to be received in cavities on the tissue-facing surface of the jaw. In other implementations, the adjunct can be coupled to the tissue-facing surface of the jaw using an adhesive. The adjunct can remain coupled to the end effector until it is separated from the end effector and transferred to a treatment site in a patient, for example by a release mechanism that includes features and/or components that are configured for releasably attaching an adjunct thereto. A variety of release mechanisms can be used, such as staple deployment members and/or a cutting element that causes the adjunct to separate from the end effector. The release mechanism can thus allow a user to securely attach an adjunct to an end effector and allow the user to rapidly deploy the adjunct when desired.

The adjunct attachment and release techniques disclosed herein can be used in combination with a variety of surgical instruments, such as a surgical stapler. 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 stapler can include a firing bar configured to drive the staples into tissue engaged between the jaws. The firing bar can include a knife or other cutting element capable of creating a cut between the staple rows along the tissue held within the jaws. The staplers can be used on a variety of tissues, for example in thoracic surgery or in gastric surgery.

<FIG> illustrates one example of a linear surgical stapler <NUM>. 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. Components of a firing system 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>.

The illustrated examples of surgical stapling instruments <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>.

A variety of different adjuncts can be used with the surgical instruments disclosed herein. "Adjuncts" are also referred to herein as "adjunct materials" or "buttresses. " 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.). 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).

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 combination thereof 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. 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>. 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., in 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 adjunct 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>.

Use of buttresses, adjuncts, and/or medicants with various surgical devices, such as surgical staplers, can necessitate attaching and releasing the adjunct from at least one tissue-contacting surface of an end effector, as discussed above. Attaching an adjunct to and releasing an adjunct from an end effector can be achieved through a variety of techniques. <FIG> illustrate one embodiment of an end effector <NUM> having an adjunct releasing mechanism. <FIG> illustrates a portion of a lower jaw <NUM> of the end effector <NUM>, which can be disposed on a distal end of a surgical instrument, such as surgical staplers <NUM>, <NUM> discussed above. The lower jaw <NUM> can have a cartridge <NUM> disposed thereon, similar to the staple cartridge <NUM>, that has a tissue-facing surface <NUM> with an adjunct <NUM> (only a portion of the adjunct <NUM> is shown) disposed thereon, such as one or more of the buttresses, adjuncts, and/or medicants discussed above.

The cartridge <NUM> can have staples disposed in staple cavities <NUM> which are formed in the tissue-facing surface <NUM>. The tissue-facing surface <NUM> can also have a channel <NUM> configured to receive a cutting element, similar to the knife blade <NUM>, as it moves distally therethrough. One or more connection cavities <NUM> can extend between and connect the staple cavities <NUM> for attaching an adjunct to the cartridge <NUM>. The connection cavities <NUM> can be in the form of recesses or bores, and can have a variety of configurations and shapes. For example, the connection cavities <NUM> can be roughly oval in shape and smaller than the staple cavities <NUM>. In other embodiments, the cavities can be circular, square, rectangular, <NUM>-dimenional shapes, etc., and they can be larger than, equal in size to, or a combination of sizes relative to the staple cavities <NUM>. The cavities <NUM> can be disposed between rows of the staple cavities <NUM>. However, the connection cavities <NUM> can have any number of configurations, such as each staple cavity <NUM> having a connection cavity <NUM> adjacent thereto. While the connection cavities <NUM> are formed adjacent to the staple cavities <NUM> on the tissue-facing surface <NUM>, they can be formed elsewhere. For example, the cavities can be formed at the interface of the cartridge and a tray, similar to tray <NUM>, such that some portion of the inner surface of the cavity is a surface of the cartridge, and another portion is a surface of the tray. Furthermore, connection cavities for attaching and detaching an adjunct need not be limited to the tissue-facing surface of the cartridge. For example, connection cavities can be formed along the edge of the tissue-facing surface of the cartridge such that when the end effector is assembled, a portion of the connection cavity will be formed by a staple tray similar to staple tray <NUM>. Alternatively, rather than connection cavities, a channel can be formed between the tissue-facing surfaces of the cartridge and the tray. Portions of the adjunct can be tucked into the channel, or adhered to the tissue-facing surface at locations proximal to the channel, during manufacturing or at any time prior to use. In such an embodiment, drivers near the outermost edge of the tissue-facing surface of the cartridge can have an adjunct releasing mechanism such that portions of the adjunct are pushed out of the channel, and/or break the adhesive bond along the channel between the adjunct and the cartridge during firing.

The adjunct <NUM> can be configured to be releasably retained on the tissue-facing surface <NUM>. The adjunct <NUM> can have protrusions or tabs disposed on a surface that contacts the tissue-facing surface <NUM>, and the protrusions can be configured to extend into and engage with the connection cavities <NUM>. The adjunct <NUM> can be configured to engage the tissue-facing surface <NUM> through a variety of means. For instance, protrusions on the adjunct can be received in the connection cavities and securely attaching due to a friction fit attachment. In such an example, an adjunct can be created by extruding a film such that it has protrusions in predefined locations that correspond to locations of the connection cavities on a tissue-facing surface of a cartridge. In other embodiments, the adjunct can be made from a VICRYL® (polyglactin <NUM>) material, and can include one or more backing layers made of polydioxanone (PDS). The one or more PDS layers can be fused to the VICRYL® material, and the one or more PDS layers can include protrusions that can be configured to extend into and mate with the connection cavities. In addition or alternatively, the adjunct can engage the tissue-facing surface through use of an adhesive, such as cyanoacrylate.

The cartridge <NUM> can have one or more staple drivers <NUM>, <NUM> movably disposed therein, similar to staple drivers <NUM>. The staple drivers <NUM>, <NUM> can be configured to move upward through the staple cavities <NUM> to apply an upward force on each of the plurality of staples within the cartridge <NUM>. The staple driver <NUM> illustrated in <FIG> can have a staple portion <NUM> that can have a staple channel <NUM> formed on an upper end thereon and that can be configured to seat a staple therein, similar to the staple driver <NUM>. The driver <NUM> can also have an adjunct releasing mechanism <NUM> attached to a side of the staple portion <NUM> and having a generally L-shaped configuration. The adjunct releasing mechanism <NUM> can have a connecting element <NUM> that connects the staple portion <NUM> to the adjunct releasing mechanism <NUM>. A post <NUM> can be attached to the connecting element <NUM> and it can extend upward in the same direction as the staple channel <NUM> of the staple portion <NUM>. The connecting element <NUM> can have an upward-angled bottom <NUM> that is configured to contact a wedge sled, similar to the wedge sled <NUM>, to allow upward movement of the driver <NUM> and firing of the staples. The post <NUM> can have a variety of shapes, such as a rectangular shape as illustrated in <FIG>, a cylindrical shape, a square, etc. In an exemplary embodiment, the post <NUM> has a shape that corresponds to a shape of the connection cavity <NUM> such that the post <NUM> can be received in the connection cavity <NUM>.

<FIG> illustrates another embodiment of a staple driver <NUM> that can be configured similar to the staple driver <NUM>. However, staple driver <NUM> can have first and second staple portions <NUM>, <NUM> similar to the staple portion <NUM> with staple channels <NUM>, <NUM> disposed on upper ends of the staple portions <NUM>, <NUM>, respectively. Each staple channel <NUM>, <NUM> can be configured to seat a staple therein, and the staple driver <NUM> can be configured to fire two staples simultaneously. The first and second staple portions <NUM>, <NUM> can have an adjunct releasing mechanism <NUM> coupled therebetween. The adjunct releasing mechanism <NUM> can include a connecting element <NUM> and a post <NUM>. The connecting element <NUM> extends between and connects the two staple portions <NUM>, <NUM>, and it has an upward-angled bottom <NUM> that is configured to contact a wedge sled, similar to the wedge sled <NUM>, to allow upward movement of the driver <NUM> and firing of the staples. The post <NUM> is attached to the connecting element <NUM> and extends upward in the same direction as the staple channels <NUM>, <NUM>. The post <NUM> can have a variety of shapes, such as a rectangular shape as illustrated in <FIG>, a cylindrical shape, a square, etc. In an exemplary embodiment, the post <NUM> has a shape that corresponds to a shape of the connection cavity <NUM> such that the post <NUM> can be received in the connection cavity <NUM>.

While the illustrated staple drivers <NUM>, <NUM> have connecting elements between the staple portions and the adjunct releasing mechanisms, a variety of connections can be used to connect multiple staple drivers. For example, two connecting elements can be used to connect three staple drivers. One skilled in the art will appreciate that a connecting element can include multiple adjunct releasing mechanisms, that multiple connecting elements can be used in parallel or in series to connect multiple staple drivers, and that the adjunct releasing mechanisms can have any number of geometries. For example, the adjunct releasing mechanisms can be curved, or can have cross-sections that are square, circular, triangular, etc. Additionally, it is possible that not all of the adjunct releasing mechanisms are uniform. The adjunct releasing mechanisms can have sharp features, as well. For example, the detachment features can be sharpened such that they can cut away a small portion of the adjunct to detach the rest from a tissue-facing surface of a cartridge.

In use, the staple drivers <NUM> and/or <NUM> can be disposed in the cartridge <NUM> and aligned with the staple cavities <NUM> and the connection cavities <NUM> such that the staple channels <NUM>, <NUM>, <NUM> are aligned with the staple cavities <NUM> and the posts <NUM>, <NUM> are aligned with the connection cavities <NUM>. The cartridge <NUM> can be loaded with staples. The adjunct <NUM> can be retained on the tissue-facing surface <NUM> by, for example, having a plurality of protrusions friction fit within the connection cavities <NUM>. The adjunct <NUM> can be applied to the tissue-facing surface <NUM> any time before use, such as during manufacture or during preparation for use, and can be applied through a variety of techniques, such as by use of an applicator.

A surgeon can maneuver the surgical stapler into position and clamp tissue between jaws of the end effector <NUM> thereon. The surgeon can then fire the surgical stapler, causing a sled, similar to wedge sled <NUM>, to move distally through the cartridge <NUM> of the end effector <NUM>. The sled can push one or more of the staple drivers <NUM>, <NUM> upwardly through the staple cavities <NUM> in the staple cartridge <NUM>. Upward movement of the staple drivers <NUM>, <NUM> applies an upward force on each of the plurality of staples within the cartridge <NUM> to thereby push the staples upwardly through the adjunct <NUM> and tissue and against an anvil surface of an upper jaw of the end effector <NUM> to form the staples. Upward movement of the staple drivers <NUM>, <NUM> also moves the posts <NUM>, <NUM> upwards. The posts <NUM>, <NUM> apply an upward force on the protrusions of the adjunct <NUM>, forcing the protrusions out of the connection cavities <NUM> as distal ends of the posts <NUM>, <NUM> enter the cavities <NUM>. Forcing the protrusions from the cavities <NUM> releases the adjunct <NUM> from the tissue-facing surface <NUM>, and the adjunct can be secured by staples to the tissue grasped by the end effector <NUM>. In other embodiments, the posts <NUM>, <NUM> can be configured to force the protrusions only partially out of the connection cavities <NUM>, which can be sufficient to loosen the adjunct <NUM> from the tissue-facing surface <NUM> enough such that the staples will remove the adjunct <NUM> entirely upon firing. In various embodiments, firing the surgical stapler can also cause a cutting element to translate through the cartridge <NUM> along the channel <NUM> to tissue while staples are fired and the adjunct <NUM> is released.

While the adjunct <NUM> can be attached to the cartridge <NUM> by protrusions, as noted above, adjuncts can be attached to a cartridge of a surgical stapler through a variety of means. For example, <FIG> illustrates an end effector <NUM> with a cartridge <NUM> and an adjunct <NUM> secured thereto by an adhesive. The end effector <NUM> can generally function and include components similar to end effector <NUM>. For example, the end effector <NUM> can include an upper jaw having an anvil (not shown) and a lower jaw <NUM> with the cartridge <NUM> engaged thereon.

The cartridge <NUM> can have staples <NUM> disposed in a plurality of staple cavities <NUM> and a plurality of connection cavities <NUM> formed in a tissue-facing surface <NUM>. The connection cavities <NUM> can have a variety of configurations and shapes. For example, the connection cavities <NUM> can be roughly oval in shape and smaller than the staple cavities <NUM>. In other embodiments, the connection cavities <NUM> can be circular, square, rectangular, etc., and they can be larger than, equal in size to, or a combination of sizes relative to the staple cavities <NUM>. The connection cavities <NUM> can be disposed between rows of the staple cavities <NUM>. However, the connection cavities <NUM> can have any number of configurations.

The adjunct <NUM> can be configured to be releasably retained on the tissue-facing surface <NUM>, and the adjunct <NUM> can be any of the adjuncts discussed herein. The adjunct <NUM> can have adhesive disposed on a surface that contacts the tissue-facing surface <NUM>. For example, there can be adhesive points <NUM> between the adjunct <NUM> and the tissue-facing surface <NUM> around outer edges of the connection cavities <NUM> that can be configured to retain the adjunct <NUM> on the cartridge <NUM>. However, a variety of different placements of the adhesive points <NUM> is possible, such as in a grid pattern. Additionally, the adhesive can be spread uniformly on the tissue-facing surface <NUM>. A variety of adhesives can be used, such as cyanoacrylate.

When the adjunct is attached to the cartridge with an adhesive, it can be desirable in various embodiments to prevent the adhesive from spilling into the cartridge, for example into a cutting element channel or into the staple cavities. Various adjuncts can be configured to include features that prevent or inhibit adhesive from spilling into the cartridge and/or specifically the cutting element channel of the cartridge during the attachment process. As an example, the adhesive points <NUM> can be formed by including small circular molded features on a surface of the adjunct <NUM> that contacts the tissue-facing surface <NUM> of the cartridge <NUM>. The circular molded features can act as reservoirs to form adhesive droplet attachment point insuring the adhesive, such as cyanoacrylate, does not enter the cartridge <NUM> and/or the cutting element channel during attachment. In other embodiments, the adhesive can be housed within the adjunct itself, or reservoirs for adhesive can be part of an applicator used to apply the adjunct to the cartridge. For example, the reservoirs can be broken as part of clamping or pulling an activation lever on the applicator.

The cartridge <NUM> can have one or more staple drivers <NUM> movably disposed therein, similar to staple drivers <NUM>, <NUM>, that can be configured to move upward through staple cavities <NUM> to apply an upward force on each of the plurality of staples <NUM> within the cartridge <NUM>. Each staple driver <NUM> can have a staple portion <NUM> that can have a staple channel <NUM> formed on an upper end thereof that is configured to seat a staple <NUM> therein. The driver <NUM> can also have an adjunct releasing mechanism attached to a side of the staple portion <NUM> and having a post <NUM> that is attached to the staple portion <NUM> and that extends upward in the same direction as the staple channel <NUM> of the staple portion <NUM>. The staple driver <NUM> can have an upward-angled bottom <NUM> that is configured to receive a wedge sled <NUM>, similar to the wedge sled <NUM>, to allow upward movement of the driver <NUM> and firing of the staple. The post <NUM> can have a variety of shapes, such as a rectangular shape, a cylindrical shape, a square shape, etc., and the post <NUM> can be configured to be received in the connection cavities <NUM>.

In use, the cartridge <NUM> can have a plurality of the staple drivers <NUM> disposed therein and loaded with staples <NUM>. The adjunct <NUM> can be retained on the tissue-facing surface <NUM> by, for example, having a plurality of adhesive points <NUM> between the adjunct <NUM> and the tissue-facing surface <NUM> around the outer edges of the connection cavities <NUM>. The adjunct <NUM> can be applied to the tissue-facing surface <NUM> any time before use, such as during manufacture or during preparation for use, and can be applied through a variety of techniques, such as by use of an applicator. A surgeon can maneuver the surgical stapler into position and clamp tissue between jaws of the end effector <NUM> thereon. The surgeon can then fire the surgical stapler, causing the sled <NUM> to move distally through the cartridge <NUM> of the end effector <NUM>. The sled <NUM> can push one or more of the staple drivers <NUM> upwardly through the staple cavities <NUM> in the staple cartridge <NUM>. Upward movement of the staple drivers <NUM> applies an upward force on each of the plurality of staples <NUM> within the cartridge <NUM> to thereby push the staples upwardly through the adjunct <NUM> and tissue and against an anvil surface of the upper jaw of the end effector <NUM> to form the staples. Upward movement of the staple drivers <NUM> also moves the posts <NUM> upwards. The posts <NUM> can apply an upward force on the adjunct <NUM>, forcing the adjunct <NUM> to move upwards and breaking the adhesive points <NUM> once the posts <NUM> move sufficiently through the connection cavities <NUM>. For example, the adhesive points <NUM> can hold firm until a distalmost end of the posts <NUM> crosses a plane of the tissue-facing surface <NUM>. Breaking, cracking, or separating the adhesive points <NUM> from between the adjunct <NUM> and the tissue-facing surface <NUM> releases the adjunct <NUM> from the tissue-facing surface <NUM>, and the adjunct <NUM> can be secured by the staples <NUM> to the tissue grasped by the end effector <NUM>. Although a distalmost end of the posts <NUM> can cross a plane of the tissue-facing surface <NUM>, the posts <NUM> can be configured such that they only extend even with, or below, the tissue-facing surface <NUM>. In some embodiments, firing the surgical stapler can also cause a cutting element to translate through the cartridge <NUM>, cutting tissue while the staples <NUM> are fired and the adjunct <NUM> is released.

While an adjunct can be attached to a lower jaw as illustrated above, an adjunct can also be attached to components of the upper jaw, such as the anvil. The upper jaw can be similar to that shown in <FIG>, but can include features and/or components for attaching and detaching an adjunct. For example, the upper jaw can be configured to include connection cavities and drivers that are driven by an E-beam to cause the adjunct to detach from the jaw. In various embodiments, when stapling is initiated, the components of the lower jaw can function to drive staples through tissue and the adjunct, while the drivers in the upper jaw can function to detach the adjunct from the anvil.

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 use with a surgical stapling instrument, comprising:
a first jaw having a staple cartridge (<NUM>) with a plurality of staple cavities (<NUM>) configured to seat staples therein, and an adjunct (<NUM>) attached to a tissue-facing surface (<NUM>) of the cartridge (<NUM>) and overlying the plurality of staple cavities (<NUM>);
a second jaw having an anvil with a plurality of staple-forming cavities formed on a tissue-facing surface (<NUM>) thereof, the first and second jaws being configured to clamp the tissue therebetween; and
a plurality of drivers (<NUM>) disposed within the cartridge (<NUM>) and configured to deploy a plurality of staples through the staple cavities (<NUM>), through the adjunct (<NUM>), and into tissue engaged between the first and second jaws, and to simultaneously cause the adjunct (<NUM>) to detach from the cartridge (<NUM>),
characterized in that each of the plurality of drivers (<NUM>) has a post (<NUM>) that is configured to extend beyond the tissue-facing surface (<NUM>) of the cartridge (<NUM>) to cause the adjunct (<NUM>) to detach from the cartridge (<NUM>).