CN106572849B

CN106572849B - Device for sealing staples in tissue

Info

Publication number: CN106572849B
Application number: CN201580042913.2A
Authority: CN
Inventors: M·J·文德利; F·E·谢尔顿四世; J·L·哈里斯; A·波斯凯
Original assignee: Ethicon Endo Surgery Inc
Current assignee: Ethicon Endo Surgery Inc
Priority date: 2014-06-10
Filing date: 2015-05-15
Publication date: 2020-07-14
Anticipated expiration: 2035-05-15
Also published as: CN106572849A; BR112016028790A2; BR112016028790B1; JP6585090B2; BR112016028790A8; JP2017521133A

Abstract

Described herein are devices and methods for sealing staples in tissue using an adjunct coupled to each staple. In one embodiment, a staple cartridge assembly is described that can include a cartridge body having a plurality of staple cavities, wherein each staple cavity has a surgical staple disposed therein. The assembly can further comprise a plurality of adjuncts, wherein each adjunct is disposed about at least one leg of a surgical staple such that, upon deployment of a surgical staple from the cartridge body, each adjunct forms a seal about the at least one leg of the surgical staple.

Description

Device for sealing staples in tissue

Technical Field

The subject matter disclosed herein relates to devices and methods for sealing staples deployed into tissue during a surgical procedure.

Background

Surgical staplers are used in surgical procedures to seal, separate and/or transect tissue in the body by closing an opening in a tissue, vessel, duct, shunt, or other object or body part involved in the particular procedure. The openings may be naturally occurring, such as blood vessels, airways or lumens or passages in organs such as the stomach, or they may be formed by the surgeon during a surgical procedure, such as by puncturing tissue or blood vessels to form a bypass or anastomosis, or by cutting tissue during a stapling procedure.

Most staplers have a handle comprising an elongated flexible or rigid shaft having a pair of opposed jaws formed on the ends thereof for holding and forming staples therebetween. At least one of the opposing jaws is movable relative to the other jaw. In the case of laparoscopic surgery, it is common for one jaw to be fixed and the other movable. In some devices (e.g., open linear staplers), the opposing jaws may be separated and reassembled by an operator to provide the relative motion required for tissue placement. Staples are typically contained in a staple cartridge that can house multiple rows of staples and are typically disposed in one of the jaws for ejection of the staples to the surgical site. In use, the jaws are positioned such that the object to be stapled is disposed between the jaws, and when the jaws are closed and the device is actuated, the staples are ejected and formed. Some staplers include a knife configured to travel between rows of staples in the staple cartridge to longitudinally cut stapled tissue between the rows of staples. Placement of the device, manipulation of components or systems of the device, and other actuation of the device (such as articulation, firing, etc.) may be accomplished in a variety of ways, such as electromechanically, mechanically, or hydraulically.

There are various types of staplers that are suitable for a particular surgical procedure. For example, a linear stapler includes a handle having an elongate shaft with a pair of opposed jaws formed on an end thereof for holding and forming staples therebetween. At least one of the opposing jaws is movable relative to the other. Staples are typically contained in a staple cartridge assembly that can house multiple rows of staples and is typically disposed in one of the jaws for ejection of the staples to the surgical site. A circular stapler has a handle and an elongate shaft, and an anvil and cartridge assembly disposed on a distal end of the elongate shaft, the anvil being axially movable relative to the cartridge assembly and configured to form staples between the anvil and the cartridge assembly and deploy the staples into tissue.

Although surgical staplers have improved over the years, a number of problems may arise. Although rare, one problem, as shown in fig. 1, is that leakage can occur due to staple S forming tears H when piercing tissue T or other objects in which staples S are disposed. Even after the staples S are fully formed, blood, air, gastrointestinal fluids and other fluids may seep through the tears H formed by the staples S. The tissue T being treated may also become inflamed due to manipulation and deformation that may occur during suturing. In addition, staples and other objects and materials implanted during the stapling procedure often lack the same characteristics as the tissue into which they are implanted. For example, staples and other objects and materials may lack the natural flexibility of the tissue in which they are implanted. Those skilled in the art will recognize that it is generally desirable to maintain as much of the natural characteristics of the tissue as possible after the staples are disposed in the tissue.

In certain cases of suturing a bronchus, such as during a lung resection, it is important that there be no leakage after suturing so that air does not inappropriately enter or exit the lung and/or chest cavity. Air escaping the stapled bronchus through leakage may interfere with breathing and lung function, such as by preventing complete inhalation of the air. The air that exits the sutured bronchi through the leak into the chest cavity is not sterile and may cause infection and/or other complications in the otherwise sterile environment of the chest cavity. However, it may be difficult to prevent leaks in the bronchi for a variety of reasons. The small size of the bronchi can make it difficult to deliver any sealing material into the bronchi, inflammation due to implanted staples and/or other objects and materials can close or nearly close the bronchi because they have a small diameter, and/or it can be difficult to seal materials introduced into the bronchi to withstand repeated inflation and deflation of the lungs without failing and/or moving within the tubes, thereby breaking the sealing of the bronchi.

In the particular case of suturing the colon, it is important to substantially seal the anastomosed staple line so that gastrointestinal solids and fluids remain in the organ. Leakage from tubular body organs (e.g., the colon) can interfere with normal digestive function and can introduce bacteria into other parts of the body, causing infection. However, it may be difficult to prevent leaks in tubular body organs for a variety of reasons. For example, it may be difficult to place tissue adjacent to the staple line to withstand the repeated inflation and deflation that occurs as solids and fluids pass through the colon. In addition, it can be difficult to deliver the sealant to the tubular body organ and control the location of the sealant as it solidifies from a liquid state to a solidified state.

Accordingly, there is a need for improved devices and methods for sealing staples in tissue.

Disclosure of Invention

The embodiments described herein address these and other challenges by providing an adjunct material, such as to seal perforations formed by surgical staples in tissue. The adjunct materials described herein have many embodiments, including embodiments in which an adjunct is disposed about an individual staple or leg thereof or about a group of staples. Various embodiments disclosed herein include adjuncts that seal staples in tissue to the crown, or staple cartridge, the sides, or to the anvil or staple leg sides (or both).

In one aspect, for example, a staple cartridge assembly is provided for use with a surgical stapler, which can include a cartridge body having a plurality of staple cavities, wherein each staple cavity has a surgical staple disposed therein. The assembly can further comprise a plurality of adjuncts, wherein each adjunct can be disposed about at least one leg of a surgical staple such that each adjunct forms a seal about the at least one leg of the surgical staple upon deployment of the surgical staple from the cartridge body.

The assembly may have many different features and/or modifications, all of which are considered to be within the scope of the present invention. For example, the auxiliary element may have many different shapes and sizes. In some embodiments, for example, each of the plurality of adjuncts can be in the form of a plug. In certain embodiments, for each surgical staple of the assembly, a first auxiliary plug can be disposed about a first leg of the surgical staple and a second auxiliary plug can be disposed about a second leg of the surgical staple such that the first and second auxiliary plugs form a seal about the first and second legs of the surgical staple.

In other embodiments, each of the plurality of adjuncts can be in the form of a pledget configured to seal around both the first and second legs of the surgical staple. The pledget itself can have many different shapes and sizes. For example, in some embodiments, the pledget may be in the form of a rectangular frame that extends along the length of the crown of the staple. Any of a variety of other shapes are also possible.

In still other embodiments, each of the plurality of adjuncts can be in the form of a cover disposed around the legs of the surgical staple. The auxiliary element may be provided around only the legs of the nail (or a portion thereof), or around the entirety of the nail.

In addition to shape and/or size, the plurality of adjuncts may be formed from a variety of materials. For example, in some embodiments, each of the plurality of adjuncts can be formed from a swellable material that expands upon contact with bodily fluids. Forming the adjunct from such materials can improve the ability of the adjunct to seal perforations in tissue formed by staple legs. Any of a variety of biocompatible swellable materials can be employed. For example, in certain embodiments, the swellable material may be a hydrogel. In still other embodiments, each of the plurality of adjuncts can be formed from other materials (such as foam).

The plurality of adjuncts can be located at various positions relative to the plurality of staples and, in certain embodiments, are configured to move relative to the staples during implantation in tissue. For example, in certain embodiments, each adjunct of the plurality of adjuncts can be positioned adjacent a crown of a surgical staple prior to deployment from the cartridge body. In other embodiments, each adjunct of the plurality of adjuncts can be positioned at a distal end of the at least one leg of the surgical staple opposite a crown of the surgical staple prior to deployment from the cartridge body. In such embodiments, for example, each of the plurality of adjuncts can be configured to slide over the at least one leg of the surgical staple. Further by way of example, if an adjunct is positioned at the distal ends of staple legs, the act of forcing the staple legs through tissue can slide the adjunct toward the crowns of the staples such that the adjunct is sandwiched between the tissue and the crowns of the staples, thereby sealing the perforations formed by the staple legs. In other embodiments, adjuncts can be positioned at other locations, such as on an anvil of a surgical stapler opposite the cartridge body, as described in more detail below.

In another aspect, a staple cartridge assembly for use with a surgical stapler is provided and can include a cartridge body having a plurality of staple cavities and a plurality of surgical staples disposed within the plurality of staple cavities and configured to be ejected from the staple cavities into tissue. The assembly can further comprise a plurality of sealing adjuncts disposed within the plurality of staple cavities and configured to be ejected from the plurality of staple cavities along with the plurality of surgical staples without contacting the cartridge body. By avoiding contact between the cartridge body and the sealing adjunct, the adjunct can be prevented from interfering with the sliding motion of the staples relative to the cartridge body.

The adjunct can be prevented from contacting the cartridge body in a number of different ways. For example, in some embodiments, each of the plurality of sealing adjuncts can be positioned such that a surgical staple protects the sealing adjunct from contact with the cartridge body during ejection. This can be accomplished, for example, by coupling one or more sealing adjuncts to the staples such that the staples guide the adjunct as they are ejected from the cartridge body, thereby protecting the adjunct from contact with the cartridge body.

Other configurations for coupling the auxiliary to the nail are also possible. For example, in certain embodiments, each of the plurality of sealing adjuncts can be positioned adjacent to a junction between a leg of a surgical staple and a crown of the surgical staple.

In still other embodiments, each staple cavity of the plurality of staple cavities can be shaped to accommodate a channel of at least one sealing adjunct coupled to a surgical staple. For example, each staple cavity of the plurality of staple cavities includes at least one cut-out formed on opposing ends of the staple cavity to accommodate the at least one sealing aid.

As described above, the auxiliary element may be formed from a variety of biocompatible materials and have any of a variety of shapes and/or sizes. In some embodiments, each of the plurality of sealing adjuncts can be configured to expand in volume upon contact with tissue.

In another aspect, a method for stapling tissue is provided that can include engaging tissue between a cartridge assembly and an anvil on a surgical stapler, and actuating the surgical stapler to eject at least one staple from the cartridge assembly into the tissue. Additionally, at least one leg of the at least one staple may extend through a sealing adjunct such that the adjunct forms a seal between the tissue and the leg.

In some embodiments, the sealing adjunct can be coupled to a distal end of the at least one leg of the at least one staple. In such embodiments, actuating the surgical stapler can slide the adjunct toward the crown of the at least one staple and seal the aperture formed in the tissue by the at least one leg. However, in other embodiments, the sealing adjunct can be coupled to a crown of the at least one staple and actuating the surgical stapler can eject the adjunct from the cartridge assembly with the crown such that the sealing adjunct is disposed between the crown of the at least one staple and the tissue.

As described above, various embodiments described herein can include sealing adjuncts positioned distal to crowns of surgical staples (such as on opposing sides of stapled tissue proximate staple legs deformed by an anvil of a surgical stapler). Also, in some embodiments, adjuncts may be positioned at both locations to seal the perforation from both sides of the tissue and/or staples.

In one aspect, a surgical device comprises an end effector that can comprise a first jaw and a second jaw, wherein the first jaw has a cartridge body removably attached thereto and the second jaw has an anvil. The cartridge body can have a plurality of staple cavities configured to seat staples therein and the anvil can have a plurality of staple forming openings formed therein. Additionally, at least one of the first jaw and the second jaw is movable relative to the other jaw. The end effector can further comprise a plurality of sealing adjunct segments coupled to each other and at least one of the first jaw and the second jaw such that staples ejected from the cartridge body pass through one of the plurality of sealing adjunct segments and tissue disposed between the first jaw and the second jaw.

In some embodiments, each of the plurality of sealing adjunct segments can span a plurality of staple forming openings. However, in other embodiments, each of the plurality of sealing adjunct segments can cover a single staple forming opening.

The plurality of sealing adjunct segments can be coupled to one another in a variety of ways. For example, in some embodiments, each of the plurality of sealing adjunct segments can be coupled to one another by a plurality of connecting branches. Additionally, at least one of the first jaw and the second jaw can include a plurality of features formed thereon configured to sever the plurality of connecting branches upon deployment of staples into tissue disposed between the first jaw and the second jaw. Breaking the connecting branches between the sealing adjuncts can allow for greater compliance of the tissue between adjacent staples, thereby reducing the force that could otherwise be used to enlarge the perforations around the staple legs.

In other embodiments, the plurality of sealing adjunct segments can be coupled to one another by a plurality of wires or by a woven mesh. In still other embodiments, the plurality of sealing adjunct segments can be coupled to one another by a connecting membrane extending over a surface of at least one of the first jaw and the second jaw. The connecting film may in some embodiments have a first thickness and each of the plurality of sealing adjunct segments may have a second, greater thickness. In certain embodiments, a greater thickness of the sealing adjunct segment can extend into the plurality of staple forming openings. In such embodiments, the plurality of sealing adjunct segments does not significantly reduce the available gap between the jaws of the surgical stapler, allowing for use with thicker tissue.

In addition to features that cut a connection between sealing adjunct segments, at least one of the first jaw and the second jaw of the end effector can further include one or more features formed on at least one of the first jaw and the second jaw configured to align and/or secure the plurality of sealing adjunct segments to at least one of the first jaw and the second jaw. Such features are configured to mate with complementary features coupled to the plurality of sealing adjuncts such that the plurality of sealing adjuncts can be temporarily coupled to the end effector in the proper position and/or orientation. Examples of such features may include shackles, plastic retainers, and the like.

In certain embodiments, the plurality of sealing adjunct segments can have the same shape and can be arranged in a repeating pattern over a length of the end effector. In other embodiments, the plurality of sealing adjunct segments can have a variety of shapes and can be arranged in an alternating pattern over the length of the end effector. Regardless, the plurality of sealing adjunct segments can cover each of the plurality of staple cavities such that each staple ejected into tissue passes through one of the plurality of sealing adjuncts.

In another aspect, an end effector for a surgical instrument is provided that includes a first jaw having a cartridge body removably attached thereto and a second jaw including an anvil having a plurality of staple forming openings formed therein. The cartridge body can have a plurality of staple cavities configured to seat staples therein and at least one of the first jaw and the second jaw can be movable relative to the other jaw. The end effector may further comprise a viscous sealant disposed within the plurality of staple forming openings of the anvil, wherein the viscous sealant within each staple forming opening is retained therein by a membrane extending across the staple forming opening. In such embodiments, the plurality of individual tacky sealant pockets can be the plurality of sealing adjunct segments described herein.

In some embodiments, the film extending across each staple forming opening may be formed from a viscous sealant that is at least partially cured by exposure to any of a chemical, ultraviolet light, and heat. However, in other embodiments, the film extending across each staple forming opening may be formed from a second material that overlies the adhesive sealant.

In addition to the film extending across each staple forming opening, in some embodiments, each staple forming opening of the plurality of staple forming openings can include at least one retainer formed thereon to help retain the adhesive sealant within the opening. In addition, while in some embodiments the membrane may extend only across each staple forming opening of the anvil, in other embodiments the membrane may also extend between adjacent staple forming openings.

In another aspect, a surgical method is provided that can include filling a plurality of staple forming openings in an anvil of a surgical stapler with a viscous sealant and forming a film over the plurality of staple forming openings in the anvil such that the film retains the viscous sealant within the staple forming openings.

As described above, in certain embodiments, forming the film may include at least partially curing the tacky sealant by exposure to any of a chemical, ultraviolet light, and heat. However, in other embodiments, forming the film may include laminating a second material over the adhesive sealant disposed within the staple forming openings.

In still other embodiments, the method can further comprise actuating the surgical stapler to drive a plurality of staples through tissue and into the plurality of staple forming openings such that the plurality of staples pierce the membrane and the adhesive sealant forms a seal around the plurality of staples.

A surgical device in the form of an applicator for coupling a adjunct material to a surgical stapler is provided. In one aspect, for example, a surgical device is provided that can include at least one nozzle formed at a proximal end of the device configured to receive a sealant, and an applicator formed at a distal end of the device configured to deliver the sealant received by the at least one nozzle. In one aspect, the applicator is removably and replaceably attachable to the nozzle. The applicator can be configured to interface with at least one of a first jaw and a second jaw of a surgical stapler such that sealant delivered from the applicator can be deposited into a plurality of openings formed in the surgical stapler. The plurality of openings can be, for example, any of a plurality of staple cavities in the cartridge body or a plurality of staple forming openings formed in the anvil.

In some embodiments, it may be desirable to prevent deposition of auxiliary materials (such as sealants) in certain areas of the surgical stapler. For example, in some embodiments, it may be desirable to keep the cutting member guide path free of sealant. Thus, in some embodiments, the surgical device can include a shield disposed within the applicator such that the shield prevents sealant delivered by the applicator from entering a cutting channel formed in at least one of the first jaw and the second jaw of the surgical stapler.

In addition, it may be desirable to remove any excess sealant from the surgical stapler prior to use. Thus, in some embodiments, the surgical device may include a scraper formed on a distal-most edge of the applicator to remove excess sealant.

There are a variety of biocompatible sealants that may be used with the devices and methods described herein. Some of these sealants may be multi-part, such as two-part sealants that must be mixed prior to coupling to the surgical stapler. Thus, in some embodiments, the surgical device can include two nozzles formed at a proximal end thereof, and the applicator can include a common lumen extending therethrough to allow the sealant received from each nozzle to mix prior to delivery from a distal end of the applicator. In still other embodiments, the two nozzles can be configured to introduce sealant into the common lumen at different rates, for example, for multi-part sealants requiring components of various mixing ratios.

In some embodiments, the surgical device can further comprise a sealant container coupled to the at least one nozzle. The container may be sealed for sterility in certain embodiments, and the at least one nozzle may include a piercing tip configured to pierce a seal formed on the container. The container may have any of a variety of shapes and/or sizes. However, in certain embodiments, the container may be a syringe.

In another aspect, a method for applying sealant to a surgical device is provided and can include applying a viscous sealant to a jaw member of a surgical stapler, wherein the jaw member includes a plurality of openings formed therein that can receive the sealant. The method may further include removing excess viscous sealant from the jaw members such that only sealant deposited within the plurality of openings remains.

The viscous sealant can be applied to the jaw members in a variety of ways. For example, in some embodiments, applying the viscous sealant to the jaw member can include sliding an applicator along a length of the jaw member as sealant is introduced through the applicator. Additionally, in certain embodiments, removing excess viscous sealant can include sliding a scraper along a length of the jaw member. In some embodiments, the applicator can include a scraper formed on a distal-most edge thereof to allow sealant to be applied and excess sealant to be removed in a single pass over the jaw member.

To help retain the viscous sealant within the plurality of openings of the jaw member (e.g., staple cavity openings in a cartridge body or staple forming openings in an anvil), the method can further comprise at least partially curing the viscous sealant after application to the jaw member. At least partially curing the viscous sealant can form a hardened layer extending across the opening that can retain uncured sealant within the opening until, for example, a staple pierces the hardened layer of the sealant from ejection of the surgical stapler. Curing the tacky sealant can be accomplished in a variety of ways, including, for example, by exposing the sealant to any of chemicals, ultraviolet light, and heat.

In another aspect, a method for stapling tissue is provided that can include applying a non-compressible sealant into a plurality of staple forming openings formed in an anvil of a surgical stapler and compressing the tissue between the anvil and a cartridge body of the surgical stapler. The method can also include actuating the surgical stapler to deliver a plurality of staples from the cartridge body through the tissue and into the plurality of staple forming openings containing the incompressible sealant. The incompressible sealant can prevent tissue compressed between the anvil and the cartridge body from entering the plurality of staple forming openings upon actuation of the surgical stapler. This may be advantageous to prevent staples from forming within (i.e., not completely through) the tissue.

As in the embodiments described above, applying the incompressible sealant may in certain embodiments include sliding an applicator along the length of the anvil. In other embodiments, applying the incompressible sealant may include mixing a multi-part sealant just prior to delivery into the plurality of staple forming openings. The multi-part sealant can be mixed in any of a variety of proportions depending on the type of sealant used.

In other embodiments, the method may further comprise removing excess sealant from the anvil. This may be accomplished using a separate squeegee or other scraping tool, or it may be accomplished in a single pass where the applicator used to deposit the incompressible sealant includes a squeegee or scraper thereon.

In still other embodiments, the method may further comprise at least partially curing the incompressible sealant after application to the anvil. Such a curing process may harden at least a portion of the incompressible sealant extending across the plurality of staple forming openings, thereby helping to retain the incompressible sealant within the plurality of staple forming openings.

The devices and methods described herein can be used with a variety of different types of tissue that traverse the body. Certain embodiments described herein may provide a more efficient procedure for forming an anastomosis between two body lumens. Such procedures are typically employed, for example, when resecting a portion of a patient's colon.

A staple cartridge assembly for use with a surgical stapler is provided and can include a cartridge body having a plurality of staple cavities, wherein each staple cavity has a surgical staple disposed therein. The assembly can also include a plurality of sealing adjuncts coupled to the cartridge body such that staples ejected from the cartridge body pass through one of the plurality of sealing adjuncts prior to entering into tissue adjacent the cartridge body. Additionally, the plurality of staple cavities can be arranged such that a greater density of staple cavities is present at the proximal end and the distal end of the cartridge body as compared to the density of staple cavities present in an intermediate portion extending between the proximal end and the distal end. Additionally, the plurality of sealing adjuncts can be positioned at the proximal end and the distal end of the cartridge body. Positioning the plurality of sealing adjuncts at the proximal and distal ends of the cartridge body can cause the sealing adjuncts to not interfere with the operation of a circular stapler that can sever tissue extending along the intermediate portion to form an anastomosis.

However, in some embodiments, the assembly can further comprise at least one suture coupled to and extending between the plurality of sealing adjuncts positioned at the proximal end and the distal end of the cartridge body. Further, to prevent interference of the at least one suture with any staples ejected from the cartridge body, the at least one suture can be offset from any staple cavities positioned in the middle portion of the cartridge body.

In other embodiments, the assembly can further comprise a washer disposed between the plurality of sealing adjuncts of the proximal and distal ends of the cartridge body and coupled to the at least one suture extending therebetween. More specifically, in certain embodiments, a first suture can extend between the at least one sealing adjunct of the proximal end of the cartridge body and the gasket, and a second suture can extend between the gasket and the at least one sealing adjunct of the distal end of the cartridge body. The first suture and the second suture may have the same or different lengths depending on the particular embodiment employed.

The gasket can be formed from a variety of materials and can have many different dimensions. In some embodiments, for example, the gasket can be configured to elastically compress when the cartridge body is compressed against tissue. In other embodiments, the washer can be rigid and the cartridge body can comprise a recess formed therein to accommodate the washer during actuation of the surgical stapler. In other embodiments, a compressible gasket can be utilized in conjunction with a cartridge body having a groove formed therein such that the amount of resilient compression required can be reduced.

The inclusion of connecting sutures and washers in the assembly may allow for complete excision of the staple line including the sealing adjunct in forming an anastomosis, as described in greater detail below.

In another aspect, a surgical method is provided that can include transecting a body cavity using a linear surgical stapler that delivers a plurality of sealing adjuncts in conjunction with a plurality of surgical staples at proximal and distal ends of a staple line formed by the surgical stapler. Additionally, the plurality of sealing adjuncts positioned at the proximal and distal ends of the staple line may be coupled to each other by at least one suture. The method may further comprise positioning a circular surgical stapler to form an anastomosis with a second body lumen across the staple line. The method can further include pulling the proximal end and the distal end of the staple line into a central lumen of the circular stapler using the at least one suture extending between the plurality of sealing adjuncts positioned between the proximal end and the distal end of the staple line, and actuating the circular stapler to form the anastomosis and excise the staple line.

In certain embodiments, the linear surgical stapler can also deliver a washer positioned at a midpoint between the proximal end and the distal end of the staple line, and the washer can be coupled to the at least one suture line.

In some embodiments, positioning the circular stapler to form an anastomosis can include traversing a stapler trocar through the staple line and through the gasket. Additionally, in certain embodiments, pulling the proximal and distal ends of the staple line into the central lumen of the circular stapler can comprise retracting the stapler trocar and the washer into the central lumen of the circular stapler. This may allow the circular stapler to completely excise the staple line including the sealing adjunct when forming the anastomosis, thereby reducing the likelihood of future leakage through the staple line formed by the linear surgical stapler.

In other embodiments, positioning the circular stapler to form an anastomosis can further comprise mating an anvil to the stapler trocar such that the anvil prevents the stapler trocar from retracting through the gasket. In such embodiments, mating the anvil to the stapler trocar can capture the gasket between the anvil and the stapler trocar such that retracting the trocar into the central lumen of the circular stapler also pulls the gasket into the central lumen.

In another aspect, a surgical method is provided that can include transecting a body cavity using a linear surgical stapler that delivers a plurality of sealing adjuncts in conjunction with a plurality of surgical staples at proximal and distal ends of a staple line formed by the surgical stapler. Additionally, the plurality of sealing adjuncts positioned at the proximal and distal ends of the staple line may be coupled to a washer positioned at a midpoint of the staple line by a plurality of sutures. The method can further include extending a trocar from a central lumen of a circular stapler cartridge disposed within the body cavity such that the trocar traverses the staple line and passes through the gasket. The method can also include coupling the trocar to an anvil positioned in a second body cavity such that a portion of the anvil receives the trocar and the gasket is captured between the anvil and the trocar. The method can further include retracting the trocar into the central lumen of the circular stapler cartridge to pull the anvil toward the circular stapler body while pulling the proximal end and the distal end of the staple line into the central lumen.

In certain embodiments, the method can further comprise actuating the circular stapler cartridge to excise the staple line and form an anastomosis between the two body lumens. As described above, actuation can excise all of the staple line formed by the linear surgical stapler because the proximal and distal ends of the staple line are pulled into the central lumen of the circular stapler as they are attached to the washer by the plurality of sutures.

Drawings

The present invention will become more fully understood from the detailed description given below when taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a side view of damaged stapled tissue;

FIG. 2 is a perspective view of one embodiment of an adjunct material secured to stapled tissue as described herein;

FIG. 3 is a perspective view of a prior art surgical instrument that may be used with one or more auxiliary materials;

FIG. 4 is an exploded perspective view of the end effector and distal end of the shaft of the instrument of FIG. 3;

FIG. 5 is a perspective view of an E-post component of the instrument of FIG. 3;

FIG. 6 is a perspective view of another prior art surgical instrument that may be used with one or more auxiliary materials;

FIG. 7 is a perspective view of another prior art surgical instrument that may be used with one or more auxiliary materials;

FIG. 8 is a top view of tissue damage that may occur near the staple legs;

FIG. 9A is a side view of an embodiment of an accessory coupled to a staple;

FIG. 9B is a side view of an alternative embodiment of an accessory coupled to a staple;

FIG. 10 is a cross-sectional view of an embodiment of an accessory coupled to a staple;

FIG. 11 is a perspective view of the auxiliary element and spike of FIG. 10;

FIG. 12 is a cross-sectional view of the staple of FIG. 10 implanted in tissue;

FIG. 13A is a diagram of one embodiment of an assistive procedure in non-thoracic tissue;

FIG. 13B is an illustration of an embodiment of an assisted procedure in breast tissue;

FIG. 14A is a side view of one embodiment of an assistive operation in tissue;

FIG. 14B is a top view of the secondary operation shown in FIG. 14A;

FIG. 15 is a perspective view of one embodiment of an accessory coupled to a staple;

FIG. 16 is a perspective view of the nail of FIG. 15;

FIG. 17A is a side view of an embodiment of an accessory coupled to a staple;

FIG. 17B is a side view of an alternative embodiment of an accessory coupled to a staple;

FIG. 17C is a side view of yet another alternative embodiment of an adjunct coupled to a staple;

FIG. 18A is a cross-sectional view of the staple of FIG. 15 positioned in a staple cartridge;

FIG. 18B is a cross-sectional view of the staple of FIG. 15 ejected into tissue;

FIG. 18C is a cross-sectional view of the adjunct in sealing the staples of FIG. 15 in tissue;

FIG. 19A is a side view of an alternative embodiment of a staple;

FIG. 19B is a side view of an alternative embodiment of a staple;

FIG. 20 is a perspective view of an alternative embodiment of an accessory coupled to a staple;

FIG. 21A is a close-up perspective view of the auxiliary element of FIG. 20 prior to implantation in tissue;

FIG. 21B is a close-up perspective view of the auxiliary element of FIG. 20 after implantation in tissue;

FIG. 22A is a side view of the nail of FIG. 20;

FIG. 22B is a cross-sectional view of the staple of FIG. 20 positioned in tissue;

FIG. 23 is a perspective view of an alternative embodiment of an accessory coupled to a staple;

FIG. 24 is a side view of the staple of FIG. 23 positioned in tissue;

FIG. 25 is a perspective view of another alternative embodiment of an accessory coupled to a staple;

FIG. 26 is a perspective view of an embodiment of a staple cartridge containing a plurality of staples having an adjunct coupled thereto;

FIG. 27 is a perspective view of an alternative embodiment of a staple cartridge containing a plurality of staples having an adjunct coupled thereto;

FIG. 28A is a top view of an embodiment of a cartridge ejection slot accommodating staples having an adjunct coupled thereto;

FIG. 28B is a top view of an alternative embodiment of a cartridge ejection slot that accommodates staples having an adjunct coupled thereto;

FIG. 28C is a top view of another alternative embodiment of a staple cartridge ejection slot that accommodates staples having an adjunct coupled thereto;

FIG. 29 is a top view of an embodiment of a plurality of adjunct segments coupled to one another;

FIG. 30 is a perspective view of an alternative embodiment of a plurality of adjunct segments;

FIG. 31A is a perspective view of one embodiment of a surgical end effector having a plurality of adjunct segments that receive a vessel;

FIG. 31B is a perspective view of the surgical end effector of FIG. 31A stapling and transecting a vessel;

FIG. 31C is a perspective view of the vessel and auxiliary element of FIG. 31A after transection;

FIG. 31D is a perspective view of the vessel and auxiliary element of FIG. 31A after removal of excess auxiliary element;

FIG. 32 is a perspective view of an alternative embodiment of a plurality of adjunct segments;

FIG. 33 is a perspective view of one embodiment of a surgical stapler anvil having a plurality of staple forming openings filled with a viscous sealant;

FIG. 34 is a perspective view of an alternative embodiment of a surgical stapler anvil having a plurality of staple forming openings filled with a viscous sealant;

FIG. 35 is a cross-sectional view of one embodiment of a staple forming opening having an adhesive sealant disposed therein and retained by a film;

FIG. 36A is a cross-sectional view of one embodiment of a staple forming opening with an adhesive sealant;

FIG. 36B is a cross-sectional view of the staple forming opening of FIG. 36A prior to curing;

FIG. 36C is a cross-sectional view of the staple forming opening of FIG. 36A after partial curing;

FIG. 36D is a cross-sectional view of the staple forming opening of FIG. 36A after being fully cured;

FIG. 37 is a side view of a surgical staple coupled to the adjunct of FIG. 35;

FIG. 38 is a perspective view of one embodiment of a membrane connecting a plurality of auxiliary elements;

FIG. 39 is a perspective view of one embodiment of a fabric with a plurality of auxiliary elements attached;

FIG. 40 is an exploded view of the fabric and auxiliary element of FIG. 39;

FIG. 41A is a perspective view of one embodiment of a plurality of auxiliary pieces coupled to each other by a curing auxiliary material film;

FIG. 41B is a perspective view of an alternative embodiment of a plurality of adjuncts that are separate from each other and that include a layer of curing adjunct material;

FIG. 42 is a cross-sectional view of one embodiment of staples, tissue, and an adjunct disposed in the staple forming openings of an anvil in a staple cartridge;

FIG. 43 is a cross-sectional view of the staple and adjunct of FIG. 35 disposed in tissue;

FIG. 44 is a cross-sectional view of the staple and adjunct of FIG. 43 being cured after implantation in tissue;

FIG. 45 is a perspective view of one embodiment of a plurality of auxiliary pieces coupled by a plurality of auxiliary material connecting branches;

FIG. 46 is an exploded view of the plurality of adjuncts of FIG. 45 disposed in a plurality of staple forming openings of a surgical stapler anvil;

FIG. 47 is a perspective view of one embodiment of a surgical stapler anvil having features for breaking connecting branches extending between a plurality of adjuncts;

FIG. 48 is a cross-sectional view of an embodiment of a surgical stapler including staples disposed in a staple cartridge and a plurality of adjuncts coupled to the anvil of FIG. 47;

FIG. 49 is a cross-sectional view of the stapler of FIG. 48 ejecting staples through tissue and into the staple forming openings of the anvil;

FIG. 50 is a cross-sectional view of the staple of FIG. 48 implanted in tissue;

FIG. 51 is a perspective cross-sectional view of one embodiment of a retainer for holding a secondary material against a surgical stapler anvil;

FIG. 52A is a cross-sectional view of the retainer and anvil of FIG. 51;

FIG. 52B is a cross-sectional view of an alternative embodiment of a retainer and anvil;

FIG. 53 is a cross-sectional view of one embodiment of a staple forming opening having a retainer formed thereon;

FIG. 54 is a cross-sectional view of the staple forming opening of FIG. 53 with an auxiliary material retained therein;

FIG. 55 is a top view of the staple forming opening of FIG. 53;

FIG. 56 is a perspective view of one embodiment of a surgical stapler anvil and staple cartridge having adjunct segments coupled thereto;

FIG. 57 is an exploded view of one embodiment of an attachment and alignment feature of a surgical stapler anvil;

FIG. 58 is a perspective view of the anvil of FIG. 57;

FIG. 59 is a perspective view of one embodiment of a surgical stapler having a plurality of adjunct segments coupled thereto and connected to one another by a membrane;

FIG. 60 is an exploded cross-sectional view of the surgical stapler of FIG. 59;

FIG. 61 is a close-up cross-sectional view of a staple forming opening of the surgical stapler of FIG. 59;

FIG. 62 is a cross-sectional view of one embodiment of a plurality of adjunct segments connected to one another by a membrane;

FIG. 63A is a cross-sectional view of the surgical stapler of FIG. 59 prior to actuation;

FIG. 63B is a cross-sectional view of the surgical stapler of FIG. 59 after actuation to deliver staples into tissue;

FIG. 64A is a perspective view of one embodiment of a surgical stapler having a plurality of adjunct segments of different thicknesses;

FIG. 64B is a close-up, exploded view of the surgical stapler of FIG. 64A;

FIG. 65 is an exploded perspective view of an alternative embodiment of a surgical stapler having a plurality of adjunct segments of different thicknesses;

FIG. 66 is a cross-sectional view of the surgical stapler of FIG. 65;

FIG. 67 is a perspective view of an alternative embodiment of a surgical stapler having a plurality of adjunct segments of different thicknesses;

FIG. 68A is an exploded view of one embodiment of a multi-material accessory;

FIG. 68B is a perspective view of the auxiliary element of FIG. 68A;

FIG. 69A is a perspective, cross-sectional view of the adjunct of FIG. 68A prior to actuation of the surgical stapler;

FIG. 69B is a perspective, cross-sectional view of the adjunct of FIG. 68A after actuation of the surgical stapler;

FIG. 70 is a cross-sectional view of one embodiment of a surgical staple and an adjunct formed in tissue;

FIG. 71 is a cross-sectional view of an alternative embodiment of a surgical staple and adjunct formed in tissue;

FIG. 72 is a cross-sectional view of another embodiment of a surgical staple and an adjunct formed in tissue;

FIG. 73A is a top view of an embodiment of a plurality of adjuncts coupled to a surgical stapler anvil;

FIG. 73B is a top view of an alternative embodiment of a plurality of adjuncts coupled to a surgical stapler anvil;

FIG. 73C is a top view of another embodiment of a plurality of adjuncts coupled to a surgical stapler anvil;

FIG. 73D is a top view of another embodiment of a plurality of adjuncts coupled to a surgical stapler anvil;

FIG. 73E is a top view of another embodiment of a plurality of adjuncts coupled to a surgical stapler anvil;

FIG. 74 is a perspective view of one embodiment of a plurality of auxiliary elements;

FIG. 75 is a top view of one embodiment of an auxiliary element segment shape;

FIG. 76 is a top view of the auxiliary elements of FIG. 75 coupled to each other;

FIG. 77 is a top view of one embodiment of an adjunct segment sheet coupled to one another;

FIG. 78 is a top view of an alternative embodiment of an adjunct segment shape;

FIG. 79 is a top view of the auxiliary elements of FIG. 78 coupled to each other;

FIG. 80A is a perspective view of one embodiment of an adjunct segment extending between adjacent surgical staples;

FIG. 80B is a perspective view of an alternative embodiment of an adjunct segment extending between adjacent surgical staples;

FIG. 80C is a perspective view of another embodiment of an adjunct segment extending between adjacent surgical staples;

FIG. 81 is a perspective view of the adjunct and surgical staples of FIG. 80A disposed in tissue;

FIG. 82 is a cross-sectional view of the adjunct and surgical staple of FIG. 81;

FIG. 83 is a perspective view of an alternative embodiment of a surgical staple and adjunct positioned in tissue;

FIG. 84 is a perspective view of another embodiment of a surgical staple and adjunct positioned in tissue;

FIG. 85 is a perspective view of another embodiment of a surgical staple and adjunct positioned in tissue;

FIG. 86 is a top view of one embodiment of a surgical staple and an adjunct extending between adjacent staples;

FIG. 87 is a top view of an alternative embodiment of a surgical staple and an adjunct extending between adjacent staples;

FIG. 88A is a side view of the surgical staple and adjunct of FIG. 87 in a relaxed state;

FIG. 88B is a side view of the surgical staple and adjunct of FIG. 87 in a tensioned state;

FIG. 89 is a top view of one embodiment of a surgical staple and an adjunct extending between adjacent staples;

FIG. 90A is a top view of an alternative embodiment of a surgical staple and adjunct connected to one another by a serpentine carrier;

FIG. 90B is a side view of the surgical staple, adjunct and snake carrier of FIG. 90A;

FIG. 91A is a side view of one embodiment of an auxiliary element;

FIG. 91B is a front view of the auxiliary element of FIG. 91A;

FIG. 91C is a top view of the auxiliary element of FIG. 91A;

FIG. 91D is a perspective view of the auxiliary element of FIG. 91A;

fig. 92A is a side view of an alternative embodiment of an auxiliary element;

FIG. 92B is a front view of the auxiliary element of FIG. 92A;

FIG. 92C is a top view of the auxiliary element of FIG. 92A;

FIG. 92D is a perspective view of the auxiliary element of FIG. 92A;

FIG. 93 is a side view of an embodiment of a plurality of adjuncts coupled to a backing material;

FIG. 94A is a side view of an embodiment of an auxiliary element;

FIG. 94B is a front view of the auxiliary element of FIG. 94A;

FIG. 94C is a top view of the auxiliary element of FIG. 94A;

FIG. 94D is a perspective view of the auxiliary element of FIG. 94A;

fig. 95A is a side view of an alternative embodiment of an auxiliary element;

FIG. 95B is a front view of the auxiliary element of FIG. 95A;

FIG. 95C is a top view of the auxiliary element of FIG. 95A;

FIG. 95D is a perspective view of the auxiliary element of FIG. 95A;

FIG. 96 is a diagrammatic representation of one embodiment of an adjunct applicator;

FIG. 97 is a cross-sectional view of the applicator of FIG. 96 applying an adjunct to a surgical stapler anvil;

FIG. 98 is a side view of the applicator of FIG. 96 applying an adjunct to a surgical stapler anvil;

fig. 99A is a diagram of an alternative embodiment of an aid applicator;

FIG. 99B is an illustration of one embodiment of a scraper that can remove excess auxiliary elements applied to a surgical stapler;

FIG. 99C is a cross-sectional view of a surgical stapler anvil having an adjunct applied thereto;

FIG. 100 is a diagram of one embodiment of a two-part adjunct applicator;

fig. 101 is a diagram of an alternative embodiment of a two-part adjunct applicator;

FIG. 102A is a cross-sectional view of one embodiment of an applicator nozzle coupled to an accessory container;

FIG. 102B is a cross-sectional view of the applicator nozzle of FIG. 102A piercing the seal formed on the accessory container;

FIG. 103 is an illustration of the applicator of FIG. 100 applying an adjunct to a surgical stapler;

FIG. 104 is a side sectional view of one embodiment of an applicator for applying an adjunct to a surgical stapler;

FIG. 105 is a front cross-sectional view of one embodiment of an applicator for applying an adjunct to a surgical stapler anvil;

FIG. 106 is a front cross-sectional view of an embodiment of an applicator for applying a two-part adjunct to a surgical stapler anvil;

FIG. 107 is a cross-sectional view of an embodiment of an adjunct disposed within a staple forming opening of a surgical stapler anvil;

FIG. 108 is a front cross-sectional view of one embodiment of an applicator for applying an adjunct to a surgical stapler cartridge;

FIG. 109 is a front cross-sectional view of one embodiment of an applicator for applying an adjunct to a surgical stapler cartridge;

FIG. 110 is a cross-sectional view of one embodiment of an auxiliary element disposed within a surgical stapler cartridge cavity;

FIG. 111 is a cross-sectional view of one embodiment of a surgical staple formed in tissue;

FIG. 112 is a diagrammatic view of one embodiment of an adjunct applicator and a surgical stapler;

FIG. 113 is a cross-sectional view of one embodiment of a surgical staple configured to capture a buttress material;

FIG. 114A is an illustration of an embodiment of a surgical stapler positioned to transect tissue;

FIG. 114B is an illustration of the tissue of FIG. 114A transected with staples and adjunct segments coupled thereto;

FIG. 114C is an illustration of the surgical stapler of FIG. 114A with excess staples and adjuncts coupled thereto;

FIG. 115 is a diagram of one embodiment of a discontinuous adjunct for forming an anastomosis;

FIG. 116 is a diagrammatic view of one embodiment of a surgical stapler cartridge used with the adjunct of FIG. 115;

FIG. 117 is a representation of one embodiment of a staple pattern for use with the adjunct of FIG. 115;

FIG. 118 is an illustration of an alternative embodiment of a discontinuous adjunct for forming an anastomosis;

FIG. 119 is a diagrammatic view of one embodiment of a surgical stapler cartridge used with the adjunct of FIG. 118;

FIG. 120 is an exploded view of the adjunct of FIG. 118 and the surgical stapler cartridge of FIG. 119;

FIG. 121 is an illustration of one embodiment of the staple pattern and adjunct of FIG. 118;

FIG. 122 is an exploded view of the surgical stapler cartridge of FIG. 119 and the adjunct of FIG. 121;

FIG. 123 is an illustration of the surgical stapler cartridge of FIG. 119 and the adjunct of FIG. 121;

FIG. 124 is a cross-sectional view of one embodiment of an adjunct washer before and during actuation of a surgical stapler;

FIG. 125 is a diagrammatic view of one embodiment of a surgical stapler cartridge used to form an anastomosis;

FIG. 126 is a diagrammatic view of one embodiment of a body cavity transected by a surgical stapler;

FIG. 127A is a cross-sectional view of a staple line including an adjunct with a gasket;

FIG. 127B is a cross-sectional view of a circular stapler trocar advancing toward the staple line of FIG. 127A;

FIG. 127C is a cross-sectional view of the circular stapler trocar of FIG. 127B taken across the staple line of FIG. 127A;

FIG. 128 is an illustration of a circular stapler trocar passing through a washer of the discontinuous accessory of FIG. 115;

FIG. 129 is an illustration of a circular stapler anvil positioned over the circular stapler trocar of FIG. 127B;

FIG. 130 is an illustration of an alternative embodiment of a circular stapler anvil positioned over the circular stapler trocar of FIG. 127B;

FIG. 131 is a cross-sectional view of one embodiment of a circular stapler anvil capturing an adjunct gasket over a circular stapler trocar;

FIG. 132 is a cross-sectional, perspective view of the circular stapler anvil, adjunct washer, and circular stapler trocar of FIG. 131;

FIG. 133 is a cross-sectional view of the circular stapler trocar of FIG. 131 withdrawn into the central lumen of the circular stapler;

FIG. 134 is a diagram of one embodiment of the forces applied to a discontinuous adjunct as a circular stapler trocar coupled thereto is withdrawn;

FIG. 135 is a cross-sectional view of the circular stapler of FIG. 131 actuated to excise a staple line including a discontinuous adjunct; and is

FIG. 136 is a cross-sectional view of an anastomosis formed by actuation of the circular stapler of FIG. 131.

Detailed Description

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 and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of such devices and methods 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 devices and methods described herein. Moreover, in the present disclosure, similarly numbered components of the various embodiments generally have similar features, where such components have similar characteristics and/or are used for similar purposes.

Reference throughout this specification to "various embodiments," "some embodiments," "one embodiment," or "an embodiment," etc., means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases "in various embodiments," "in some embodiments," "in one embodiment," or "in an embodiment," or the like, throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, a particular feature, structure, or characteristic shown or described in connection with one embodiment may be combined, in whole or in part, with features, structures, or characteristics of one or more other embodiments, without limitation. Such modifications and variations are intended to be included within the scope of the methods, apparatus, devices, and systems described herein.

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

It may be desirable to use one or more biological and/or synthetic materials (collectively referred to herein as "adjunct materials") in conjunction with a surgical instrument to help improve a surgical procedure. These biological materials may be from human and/or animal sources. Those skilled in the art may refer to these types of materials as support materials as well as auxiliary materials.

Various exemplary devices and methods for performing surgical procedures are provided. In some embodiments, these devices and methods provide for open surgical procedures, and in other embodiments, these devices and methods provide for laparoscopic, endoscopic, and other minimally invasive surgical procedures. These devices may be fired directly by a human user or remotely under the direct control of a robot or similar manipulation tool. However, those skilled in the art will appreciate that the various methods and devices disclosed herein may be used in many surgical procedures and applications. Those skilled in the art will further appreciate that the various instruments disclosed herein may be inserted into the body in any manner, such as through a natural orifice, through an incision or puncture made in tissue, or through an access device such as a trocar cannula. For example, the working portion or end effector portion of the instrument can be inserted directly into the body of a patient or can be inserted through an access device having a working channel through which the end effector and elongate shaft of the surgical instrument can be advanced.

The end effector of a surgical instrument as described herein can be configured to deliver one or more synthetic and/or biological materials (collectively referred to herein as "adjunct materials") to a surgical site to help improve a surgical procedure. These biological materials may be from human and/or animal sources. While various end effectors may benefit from the use of a secondary material, in some exemplary embodiments, the end effector may be a surgical stapler. When used in conjunction with a surgical stapler, the one or more adjunct materials can be disposed between and/or over jaws of the stapler, incorporated into a staple cartridge disposed in the jaws, or otherwise placed adjacent to the staples. When the staples are deployed, the one or more adjunct materials can remain with the staples at the treatment site, which in turn provides a number of benefits. In some cases, the one or more adjunct materials can be used to help seal the holes formed by the staples as they are implanted in tissue, blood vessels, and various other objects or body parts, and/or can be used to provide tissue reinforcement at the treatment site. If the tissue is diseased, heals from another treatment, such as radiation treatment, drug treatment, such as chemotherapy, or other tissue property changing condition, tissue augmentation may be required to prevent the staples from tearing open the tissue. In some cases, the one or more adjunct materials can minimize tissue movement (e.g., lung distension, gastrointestinal tract distension, etc.) in and around the staple puncture site that can occur due to tissue deformation that occurs after stapling. Those skilled in the art will recognize that the staple perforation site may act as a stress concentrator and that the size of the hole formed by the staple will expand when the tissue surrounding it is placed under tension. Limiting tissue movement around these puncture sites minimizes the size to which the aperture can expand under tension. In some cases, the one or more adjunct materials can be configured to wick or absorb beneficial fluids that further promote healing, such as sealants, blood, adhesives, and in some cases, the one or more adjunct materials can be configured to degrade to form gels, such as sealants, that further promote healing. In some cases, the adjunct can carry a material that forms a sealant to form a seal when placed into a wet environment (e.g., blood, water, saline, or other bodily fluids) (e.g., a human or animal source from fibrinogen and thrombin can be lyophilized into a powder form that forms a sealant when mixed with water). In addition, the one or more materials may help reduce inflammation, promote cell growth, and otherwise improve healing.

Fig. 2 shows an embodiment of an adjunct material comprising a porous support 30 that can be secured to the tissue T to be treated by a surgical stapler and remain at the treatment site with staples 70. The support 30 may be made of one or more absorbent materials and may be stamped, pressed, cut, molded, braided, melted, blown, constructed of composite structures and/or methods, or otherwise shaped to facilitate absorption, enhancement, delivery, and/or retention of beneficial fluids such as sealants, adhesives, blood, and the like. Absorption and/or retention of beneficial fluid (e.g., fibrin sealant 40) at the treatment site may further help prevent leakage and strengthen the buttress 30.

In use, the adjunct material can be preloaded onto the device and/or staple cartridge, while in other instances, the adjunct material can be packaged separately. With the adjunct material preloaded onto the device and/or staple cartridge, the stapling procedure can be performed as known to those skilled in the art. For example, in some instances, firing of the device may be sufficient to cause the adjunct material to disassociate from the device and/or staple cartridge, thereby eliminating the need for further action by the clinician. In other instances, any remaining connecting or retaining members that associate the adjunct material with the device and/or staple cartridge can be removed prior to removing the instrument from the surgical site, leaving the adjunct material at the surgical site. Where the secondary material is separately packaged, the material may be releasably coupled to at least one of the end effector and components of the staple cartridge prior to firing the device. The auxiliary material may be refrigerated and thus removed from the refrigerator and associated packaging and then coupled to the device using a connecting or retaining member as described herein or otherwise known to those skilled in the art. The suturing procedure may then be performed as known to those skilled in the art, and if necessary, the adjunct material may be dissociated from the device as described above.

The adjunct materials described herein can be used in any surgical procedure in which a surgical stapler or other instrument is utilized to form a tissue perforation. In some embodiments, the adjunct materials described herein can be used to seal staple perforations formed when a surgical stapler is used in a lung procedure. When performing a surgical procedure on the lung (e.g., a lobectomy, a segmental resection, a wedge resection, a lung volume reduction, etc.), the lung is typically collapsed and then the desired procedure is performed on the collapsed lung, including applying a stapler to the tissue to be removed. After the procedure is completed, the collapsed lung is re-inflated. Re-expansion of the lung stretches the lung parenchyma, which can lead to increased stress at the junction between the sutured tissue and the surrounding tissue that is not punctured. In addition, nail punctures of the lungs require hermetic sealing. Such hermetic seals can be difficult to achieve due to lung tissue movement. While leaks around a pin puncture typically heal within about five days, in some cases, the pin puncture may last for a longer period of time, such as, for example, up to six months.

Accordingly, some embodiments provide an adjunct material useful for sealing staple punctures formed by surgical staplers used to secure lung tissue. However, it should be understood that the adjunct material may also be used to seal a perforation formed by a surgical stapler used to secure any other type of tissue, such as, for example, blood vessel, intestinal, gastric, and esophageal tissue.

Surgical stapling instrument

While a variety of surgical instruments can be used in conjunction with the adjunct materials disclosed herein, FIG. 3 illustrates one non-limiting exemplary embodiment of a surgical stapler 10 suitable for use with one or more adjunct materials. The instrument 10 generally includes a handle assembly 12, a shaft 14 extending distally from a distal end 12d of the handle assembly 12, and an end effector 50 located at a distal end 14d of the shaft 14. Since the illustrated embodiment is a surgical stapler, the end effector 50 has jaws 52,54, although other types of end effectors may be used with the shaft 14, handle assembly 12, and components associated therewith. Surgical stapler 10 includes opposing lower jaw 52 and upper jaw 54, wherein lower jaw 52 includes a staple channel 56 (fig. 4) configured to support a staple cartridge 60, and upper jaw 54 has an inner surface 58 facing lower jaw 52 and configured to operate as an anvil to assist in deploying staples 70 of staple cartridge 60. The jaws 52,54 are configured to move relative to one another to clamp tissue or other objects disposed therebetween, and components of the firing system are configured to pass through at least a portion of the end effector 50 to eject staples into the clamped tissue. In various embodiments, a blade 81 may be associated with the firing system to cut tissue during the stapling procedure. At least one of the opposing lower and upper jaws 52,54 will be movable relative to the other lower and upper jaws 52, 54. At least one of the opposing lower and upper jaws 52,54 may be fixed or otherwise immovable. In some embodiments, both of the opposing lower jaw 52 and upper jaw 54 will be movable.

The operation of the end effector 50 may begin with clinician input at the handle assembly 12. the handle assembly 12 may have a number of different configurations designed to manipulate and operate the end effector 50 associated therewith. in the illustrated embodiment, the handle assembly 12 has a pistol grip-type housing 18 having various mechanical and/or electrical components disposed therein to operate various features of the instrument. for example, the handle assembly 12 may include a clamping member mounted adjacent to its distal end 12d that may facilitate rotation of the shaft 14 and/or end effector 50 relative to the handle assembly 12 about a longitudinal axis L of the shaft 14. the handle assembly 12 may also include a firing member that is part of a clamping system actuated by the clamping trigger 22 and a firing member that is part of a firing system actuated by the firing trigger 24. the clamping trigger 22 and the firing trigger 24 may be biased to an open position relative to the fixed handle 20, for example by a torsion spring.movement of the clamping trigger 22 toward the fixed handle 20 may actuate the clamping system described below, which may cause the jaws 52,54 to draw and thereby pinch tissue between each other clamping systems, and may be advanced between, and thereby enabling the firing of the firing system to cut, or eject tissue as may be interpreted by a person using various electro-mechanical firing and/or electro-mechanical firing systems (e.g., a firing system) that may be disposed between the firing system that may be employed to sever and/or otherwise be employed to sever tissue.

As shown in greater detail in fig. 4, the end effector 50 of the illustrated embodiment is a surgical stapling tool having a lower jaw 52 that acts as a cartridge assembly or carrier and an opposing upper jaw 54 that acts as an anvil. A staple cartridge 60 having a plurality of staples 70 therein is supported in a staple tray 57, which is in turn supported within the cartridge channel of the lower jaw 52. The upper jaw 54 has a plurality of staple forming pockets 66 (fig. 11), each of which is positioned over a respective staple from a plurality of staples 70 contained within the staple cartridge 60. The upper jaw 54 can be connected to the lower jaw 52 in a variety of ways, but in the illustrated embodiment, the upper jaw 54 has a proximal pivot end 54p that is pivotally received within a proximal end 56p of the staple channel 56 just distal of its engagement with the shaft 14. As upper jaw 54 pivots downwardly, upper jaw 54 moves anvil surface 58 and the staple forming pockets 66 formed thereon toward the opposing staple cartridge 60.

Opening and closing of the jaws 52,54 to selectively clamp tissue therebetween can be accomplished using a variety of clamping components. In the illustrated embodiment, the pivoting end 54p of the upper jaw 54 includes a closure feature 54c distal to its pivotal attachment to the staple channel 56. Thus, the closure tube 82, which includes a horseshoe aperture 82a at its distal end that engages the closure feature 54c, selectively imparts an opening motion to the upper jaw 54 during proximal longitudinal movement and a closing motion to the upper jaw 54 during distal longitudinal movement of the closure tube 82 in response to the clamping trigger 22. Those skilled in the art will appreciate that opening and closing of the end effector 50 may be accomplished by relative movement of the lower jaw 52 with respect to the upper jaw 54, relative movement of the upper jaw 54 with respect to the lower jaw 52, or by movement of the two jaws 52,54 with respect to each other.

The firing component of the illustrated embodiment can include a firing bar 84 having an E-post 86 on its distal end as shown in fig. 5. The firing bar 84 is contained within the shaft 14, such as in a longitudinal firing bar slot 14s of the shaft 14, and is guided by the firing motion from the handle 12. Actuation of the firing trigger 24 may affect distal movement of the E-pillar 86 through at least a portion of the end effector 50, thereby causing firing of the staples 70 contained within the staple cartridge 60. In the illustrated embodiment, a guide 85 protruding from the distal end of the E-pillar rod 86 can engage a wedge sled 90, which in turn can push staple drivers 92 upward through staple cavities 68 formed in staple cartridge 60. The upward movement of the staple drivers 92 applies an upward force to each of the plurality of staples 70 within the cartridge 60, thereby urging the staples 70 upwardly against the anvil surface 58 of the upper jaw 54 and forming formed staples 70'.

In addition to causing the firing of staples, E-post 86 can be configured to facilitate the closure of jaws 52,54, the spacing of upper jaw 54 from staple cartridge 60, and/or the severing of tissue captured between jaws 52, 54. In particular, a pair of top pins 87 and a pair of bottom pins 89 can engage one or both of the upper jaw 52 and the lower jaw 54 to compress the jaws 52,54 toward one another as the firing bar 84 is advanced through the end effector 50. At the same time, knife 81, which extends between top pin 87 and bottom pin 89, can be configured to sever tissue captured between jaws 52, 54.

In use, the surgical stapler 10 may be disposed in a cannula or port and at a surgical site. Tissue to be cut and stapled can be placed between the jaws 52,54 of the surgical stapler 10. Features of stapler 10 can be manipulated by the clinician as desired to achieve a desired position of jaws 52,54 at the surgical site and tissue relative to jaws 52, 54. After proper positioning has been achieved, the clamping trigger 22 may be pulled toward the stationary handle 20 to actuate the clamping system. The trigger 22 may operate the components of the clamping system such that the closure tube 82 is advanced distally through at least a portion of the shaft 14 to collapse at least one of the jaws 52,54 toward the other to clamp tissue disposed therebetween. The trigger 24 can then be pulled toward the stationary handle 20 to operate the components of the firing system such that the firing bar 84 and/or the E-post 86 are advanced distally through at least a portion of the end effector 50 to effect firing of the staples 70 and optionally sever tissue captured between the jaws 52, 54.

Another embodiment of a surgical instrument 100 is shown in fig. 6. Similar to the surgical instrument 10, the surgical instrument 100 includes a handle assembly 112 and a shaft 114 extending distally therefrom and having an end effector 150 on a distal end thereof for treating tissue. The upper jaw 154 and the lower jaw 152 of the end effector 150 can be configured to capture tissue therebetween, staple the tissue by firing staples from a cartridge 160 disposed in the lower jaw 154, and/or form an incision in the tissue. In this embodiment, the attachment portion 116 on the proximal end of the shaft 114 can be configured to allow the shaft 114 and the end effector 150 to be removably attached to the handle assembly 112. In particular, the mating feature 125 of the attachment portion 116 may mate to a complementary mating feature 123 of the handle assembly 112. Mating features 123,125 may be configured to be capable of being coupled together by, for example, a snap-fit coupling, a bayonet coupling, or the like, although any number of complementary mating features and any type of coupling may also be used to removably couple shaft 114 to handle assembly 112. Although the entire shaft 114 of the illustrated embodiment is configured to be detachable from the handle assembly 112, in some embodiments, the attachment portion 116 is configured to allow only a distal portion of the shaft 114 to be detached. The detachable coupling of the shaft 114 and/or the end effector 150 may allow for selective attachment of a desired end effector 150 for a particular procedure and/or reuse of the handle assembly 112 for a plurality of different procedures.

Handle assembly 112 may have one or more features thereon for manipulating and operating end effector 150. By way of non-limiting example, a knob 126 mounted on a distal end of the handle assembly 112 may facilitate rotation of the shaft 114 and/or end effector 150 relative to the handle assembly 112. The handle assembly 112 can also include a clamping component as part of a clamping system that is actuated by the trigger 122 and a firing component as part of a firing system that can also be actuated by the trigger 122. Thus, in some embodiments, movement of the trigger 122 toward the fixed handle 120 through the first range of motion can actuate the clamping member to move the opposing jaws 152,154 toward one another toward the closed position. Further movement of the trigger 122 toward the stationary handle 120 through the second range of motion can actuate a firing member to cause ejection of staples from the staple cartridge 160 and/or advancement of the knife to sever tissue captured between the jaws 152, 154.

Another embodiment of a surgical instrument 200 is shown in fig. 7. Similar to surgical instruments 10 and 100, surgical instrument 200 includes a handle assembly 212 and a shaft 214 extending distally therefrom and having an end effector 250 on its distal end for treating tissue. The end effector 250 may include a cartridge assembly 252 and an anvil 254 each having a tissue contacting surface 260p,260d that is substantially circular in shape. The cartridge assembly 252 and anvil 254 can be coupled together by a shaft 262 extending from the anvil 254 to the handle assembly 212 of the stapler 200, and the actuator 222 on the manipulating handle assembly 220 can retract and advance the shaft 262 to move the anvil 254 relative to the cartridge assembly 252. In one embodiment, the shaft 262 can be formed from a first portion and a second portion (not shown) that are configured to be releasably coupled together to allow the anvil 254 to be separated from the cartridge assembly 252, thereby allowing greater flexibility in positioning the anvil 254 and the cartridge assembly 252 in the body. For example, a first portion of the shaft can be disposed within the cartridge assembly 252 and extend distally beyond the cartridge assembly 252, terminating in a distal mating feature. A second portion of the shaft 214 can be disposed within the anvil 254 and extend proximally out of the cartridge assembly 252, terminating in a proximal mating feature. In use, the proximal and distal mating features may be coupled together to allow the anvil 254 and cartridge assembly 252 to move relative to one another. The anvil 254 and cartridge assembly 252 may perform various functions and may be configured to capture tissue therebetween, staple the tissue by firing staples from the cartridge assembly 252, and/or may form an incision in the tissue. Generally, the cartridge assembly 252 can house a cartridge containing staples and can deploy the staples against the anvil 254 to form a circular staple pattern around the periphery of the tubular body organ.

Handle assembly 212 of stapler 200 can have various actuators disposed thereon that can control the movement of the stapler. For example, the handle assembly 212 may have a knob 226 disposed thereon to facilitate positioning of the end effector 250 by rotation, and/or a trigger 222 for actuating the end effector 250. Movement of the trigger 222 through the first range of motion can actuate components of the clamping system to approximate the jaws, i.e., move the anvil 254 toward the cartridge assembly 252. Movement of the trigger 222 through the second range of motion may actuate components of the firing system to cause deployment of staples from the staple cartridge assembly 252 and/or advance of a knife to sever tissue captured between the cartridge assembly 252 and the anvil 254.

The illustrated embodiments of

surgical stapling instruments

10, 100, and 200 provide but a few examples of the many different configurations and associated methods of use that can be used in conjunction with the disclosure provided herein. While the illustrated embodiments are each configured for minimally invasive procedures, it should be understood that instruments configured for open surgical procedures, such as the open linear stapler described in U.S. patent No. 8,317,070, may be used in conjunction with the disclosure provided herein. Further details regarding the illustrated embodiments, as well as other exemplary embodiments of surgical staplers, components thereof, and associated methods of use thereof, that can be used in accordance with the present disclosure include those devices, components, and methods provided in the following patents: U.S. publication No. 2013/02 14/075,438 7, U.S. patent No. 8,393,514, U.S. patent No. 8,317,070, U.S. patent No. 7,143,925, U.S. patent application No. 14/074,884 entitled "Sealing Materials for Use in Sealing Procedures" and filed on 8.11.2013, U.S. patent application No. 14/074,810 entitled "Hybrid joining Materials for Use in Sealing Procedures" and filed on 8.11.2013, U.S. patent application No. 14/074,810 entitled "potting Charged capable of imaging Materials and Method of Forming the Same" and filed on 8.11.2013, U.S. patent application No. 14/075,459 entitled "Sealing Materials and Method of Using Same" and filed on 11.8.2013, U.S. patent application No. 14/075,459 entitled "Sealing Materials and Method of Using Materials" and filed on 8. 14/074,902.3.11.3 and filed on 3526.3.s.3 Each of the above patents is incorporated herein by reference in its entirety.

Exemplary compositions for auxiliary materials

Regardless of the configuration of the surgical instrument, embodiments described herein may provide for the use of implantable materials (e.g., synthetic and/or biological materials, collectively referred to as "adjunct materials") in connection with the operation of the instrument. As explained in more detail below, the adjunct material disclosed herein can be releasably coupled to lower jaw member 52 and upper jaw member 54 in a variety of ways to allow the adjunct material to be separated from the jaw members upon actuation of end effector 50. More specifically, the adjunct material can be captured by staples 70 along with tissue disposed between jaw members 52, 54. The adjunct material can remain in the patient when the stapler is removed from the patient. While many devices and methods for attaching a buttress material to an end effector of a surgical instrument are described below, other devices and methods can be found in U.S. patent publication No. 2013/0256377 and U.S. patent publication No. 2013/0153641, which are incorporated by reference herein in their entirety.

The adjunct materials used in conjunction with the disclosure provided herein can have any number of configurations and properties. Generally, the adjunct material can be made of, for example, a bioabsorbable material, a biodegradable material, and/or a material that is otherwise capable of being decomposed such that the adjunct material can be absorbed, dissolved, disintegrated, and/or decomposed during the healing process. In at least one embodiment, the adjunct material can be configured to degrade over time to form a gel (e.g., a sealant) to aid in wound healing. In other embodiments, the adjunct material can include, for example, a therapeutic agent that can be configured to release over time to aid in tissue healing. In other various embodiments, the secondary material may include, for example, a non-absorbable material and/or a material that cannot be decomposed.

Some particularly advantageous auxiliary materials may include porous polymer scaffolds that may be configured to be broken down, for example, by exposure to water such that the water attacks the polymer bonds of the material. The degraded material may be configured to gel over the wound site, thereby coating injured tissue, such as injured soft tissue, which may help compress, seal, and/or generally create an environment at the wound site that promotes healing of the tissue. In particular, such degradable polymers may allow the tissue itself to be a load bearing component. In some embodiments, the degraded material may include a chemoattractant that attracts natural healing compounds to the wound site. The polymeric scaffold can be configured to have a desired degradation rate, for example within minutes to hours after attachment to tissue, to aid the healing process almost immediately after attachment. For more details on the porous Polymer scaffolds described herein, see the Elastomeric biomaterials for tissue engineering, Progress in Polymer Science 38(2013)584 671 of Q.Chen et al, which is incorporated herein by reference in its entirety.

In some embodiments, the porous polymer scaffolds described herein can be physically crosslinked, which can allow the polymer to be formed into a variety of complex three-dimensional shapes, such as fibers, sheets, membranes, and the like, having any desired porosity, surface-to-volume ratio, and mechanical properties. The scaffold can be formed into the desired form by a variety of methods, such as by extrusion, wet spinning, electrospinning, Thermally Induced Phase Separation (TIPS), salt leaching/freeze drying, and the like. When the stent is formed as a film or sheet, the film or sheet may have any desired thickness, for example, in the range of about 50 to 750 μm or in the range of about 1 to 3mm, depending on the desired application.

In an exemplary embodiment, the scaffold comprises three layers, a first layer may be made of polyestercarbonate urethane urea (PECUU), a second layer may be made of poly (ester urethane) urea (PEUU), and a third layer may be made of poly (carbonate urethane) urea (PCUU) lysine triisocyanate (L TI) or Hexamethylene Diisocyanate (HDI), one skilled in the art will appreciate that the properties of each layer may be optimized to achieve desired results and performance in some embodiments, the desired properties of the scaffold may be achieved by blending or copolymerizing the material of the third layer or with various polymers or copolymers.

The three layers of film may be configured to degrade almost immediately upon attachment to tissue, for example within about 1 to 2 hours after attachment, but each of the three layers may be configured to degrade in different ways to have different healing benefits.

In exemplary embodiments, PHAs may be naturally formed by various microorganisms (e.g., gram-negative or gram-positive bacteria), or they may be synthesized, for example, with the PHA (polyhydroxyalkanoate) polymers available from Zeneca of L ondon, United Kingdom

In one embodiment, the PHA may be copolymerized and/or blended with one or more additional materials, by way of non-limiting examples, the PHA may be copolymerized with a Hydroxyvalerate (HV), a Hydroxybutyrate (HB), and/or a hydroxyhexanoate (HH), which may reduce the level or crystallinity and/or brittleness of the PHA.

In other embodiments, the scaffold may be synthesized from poly (polyol sebacate) (PPS), for example from poly (glycerol-sebacate) (PGS). Such stents may be particularly biocompatible and may provide the additional advantage of reducing the risk of infection in addition to promoting healing. Other exemplary embodiments may be synthesized from xylitol-based elastomers, such as polygalactol sebacate (PXS), which may provide structural stability over a clinically desirable period and/or may slowly enter the metabolic pathway without causing rapid fluctuations in blood glucose levels. A scaffold made of PXS may be formed as a thicker film, providing greater compression to the wound site, and may be configured to be able to degrade in the range of about 10 hours to 8 days after attachment. Still other exemplary embodiments may be synthesized from poly (glycerol sebacate-co-acrylate) (PGSA)), which may promote tissue ingrowth into the scaffold, particularly when formed into fibers, and/or may serve as an antimicrobial agent. PGSA stents may be used as a replacement for traditional surgical sutures and staples, and/or may be used as a waterproof sealant for hollow organ anastomoses (e.g., catheters, bowel, etc.), 2D mesh grafts (e.g., treatment of hernias, ulcers, burns, etc.), and/or wound dressings (e.g., hemostatic patches, etc.). PGSA may be combined with glycerol, which may allow the scaffold to persist in situ for longer periods, e.g., up to 20 days.

In another embodiment, the scaffold may be made of Poly (-caprolactone) (PC L) which may be blended with Silk Fibroin (SF) and may be formed into a very thin film, PC L/SF Blend may have highly biocompatible properties and/or may improve the attachment and/or proliferation of cells to the scaffold, for example, when implanted on tissue, the scaffold may release Silk proteins into the tissue, thereby promoting faster healing, almost immediate hemostasis, and/or attract more fibroblasts PC L components may further aid the healing process by providing mechanical compression to the injured tissue, higher PC L content may provide better mechanical properties, while higher SF content may provide better degradation properties.

In still other embodiments, the stent may comprise PC L coated with gelatin the stent may be arranged in one or more layers, for example where PC L acts as a substrate PC L may be used to increase the mechanical strength of the stent and/or may support fibroblast adhesion and cell proliferation more details regarding the nature and manufacturing process of a stent made from gelatin coated PC L may be found in Biodegradable fibrous scaffold coated colloidal porous of gelatin coated poly (-cellulose) precipitated collagen, J.biomed Mater Res 83A:372-382(2007), incorporated herein by reference in its entirety.

Table 1 below summarizes exemplary molecular weight ranges, approximate absorption times, and average dimensions for membranes made from the foregoing porous polymer scaffold materials. One skilled in the art will appreciate that the ranges provided in table 1 are not intended to be limiting, and that the molecular weight of any of the polymers described herein can be varied to achieve desired degradation properties.

TABLE 1：

Other suitable auxiliary materials may include absorbable polyurethanes, such as polyurethanes derived from aromatic absorbable isocyanates, which may be similar to methylene bis (phenyl isocyanate) (MDI) and chain extender glycols. Absorbable polyurethanes can be configured to hydrolyze upon hydrolysis to degrade into safe and biocompatible products. Non-limiting examples of hydrolyzable aromatic isocyanates that may be used to form absorbable polyurethanes include glycolic acid diisocyanate, caprolactone-diisocyanate, glycolate-ethylene glycol-glycolate, glycolate-diethylene glycol-glycolate, lactate-diethylene glycol-lactate, glycolic acid and trimethylpropane triesters, and glycolic acid and pentaerythritol tetraesters.

Another particularly advantageous adjunct material that can be used in conjunction with the disclosure provided herein is a material that forms a multilayer dressing particularly suitable for absorbing and retaining fluids when compressed, for example, by an application peg, as disclosed in U.S. publication No. 2006/0257458, which is incorporated herein in its entirety. Other exemplary, non-limiting embodiments of synthetic materials (e.g., as a support) that can be used in conjunction with the disclosure provided herein include biodegradable, synthetic absorbable polymers, such as those under the trademark Viton @

A polydioxan membrane sold or having a polyglycerol sebacate (PGS) or other biodegradable membrane formed of PGA (polyglycolic acid and its various forms, sold under the trade marks Vicryl, Dexon and/or neoviel), PC L (polycaprolactone), P L a or P LL a (polylactic acid), PHA (polyhydroxyalkanoate), PGC L (poliglecaprone 25,sold under the trademark Monocryl), panary L (Ethicon, inc., Somerville, NJ), polylactone 910, polydextrose, PGA/TMC (polyglycolide-trimethylene carbonate, sold under the trademark Biosyn), Polyhydroxybutyrate (PHB), polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), Polydioxanone (PDO) and its various forms (sold, for example, under the trademark PDS), or blends or copolymers of any of the above.

Some non-limiting examples of biologically-derived materials that can be used in conjunction with the disclosure provided herein (e.g., as sealant materials) include Platelet Poor Plasma (PPP), Platelet Rich Plasma (PRP), starch, chitosan, alginate, cellulose, thrombin, polysaccharides, cellulose, collagen, bovine pericardium, gelatin-resorcinol-formalin adhesive, oxidized regenerated cellulose, mussel-based adhesive, polyamino acids, agarose, polyetheretherketone, amylose, hyaluronic acid, transbright hyaluronic acid, lactalbumin, cellulose gum, starch, gelatin, silk, those available from Davol inc

Available from Baxter, Deerfield, Illinois

Or other material suitable for mixing with the biomaterial and introduction into the wound or defect site, including combinations of materials, or any material apparent to those skilled in the art in view of the disclosure provided herein. The biological material may be from a number of sources, including from a patient into which the biological material is to be implanted, a human or other animal that is not a patient into which the biological material is to be implanted.

Additional disclosure regarding synthetic or polymeric materials and biomaterials that may be used in conjunction with the disclosure provided herein may be found in U.S. patent No. 7,772,352, PCT publication No. WO 2014/016819, U.S. patent application publication No. 2006/0257458, U.S. patent application publication No. 2012/0080335, U.S. patent application publication No. 2012/0083835, U.S. patent application publication No. 2013/0256372, U.S. patent application publication No. 2013/0256365, U.S. patent application publication No. 2013/0256376, U.S. patent application No. 13/710,931 entitled "electrochemical energy with tissue harvesting catalysts" and filed on 12.11.2012, and U.S. patent application No. 13/763,192 entitled "Multiple Thickness plant L a layers for Surgical stacking Devices" and filed on 2013 on 2.8.8.A, each of which is incorporated herein by reference in its entirety.

In use, the adjunct material can be preloaded onto the device and/or staple cartridge, while in other instances, the adjunct material can be packaged separately. With the adjunct material preloaded onto the device and/or staple cartridge, the stapling procedure can be performed as known to those skilled in the art. For example, in some instances, firing of the device may be sufficient to cause the adjunct material to disassociate from the device and/or staple cartridge, thereby eliminating the need for further action by the clinician. In other instances, any remaining connecting or retaining members that associate the adjunct material with the device and/or staple cartridge can be removed prior to removing the instrument from the surgical site, leaving the adjunct material at the surgical site. Where the secondary material is separately packaged, the material may be releasably coupled to at least one component of the end effector, such as a staple cartridge, prior to firing the device. The auxiliary material may be refrigerated and thus removed from the refrigerator and associated packaging and then coupled to the device using a connecting or retaining member as described herein or otherwise known to those skilled in the art. The suturing procedure may then be performed as known to those skilled in the art, and if necessary, the adjunct material may be dissociated from the device as described above.

Special auxiliary part for crown side nail

As described above and shown in FIG. 8, the perforations formed by the staples fired from the surgical stapler can result in leakage of blood, air, or other fluids depending on the type of tissue being stapled. More specifically, the tissue may be stretched in any of the

various directions

4002,4004 after staples 4006 are implanted therein, thereby stretching perforations 4008,4010 formed by the staple legs. In some cases, even if the sutured ends of a vessel or other body cavity are successfully sealed, there may be bleeding or other leakage through the staple puncture.

One advantage of the tissue aid is its property of preventing or minimizing leakage, such as fluid or gas leakage. The tissue aid may perform this function by one or more of the following mechanisms: plugging or tearing holes appearing at the nail piercing locations; limiting the movement of tissue around the staple puncturing site to prevent an increase in staple hole size and/or prevent tissue tearing; and minimizing a strain gradient that occurs between constrained tissue within the staple line and free tissue adjacent to the staple line.

Embodiments of the devices and methods described herein may address leaks from perforations 4008,4010 by providing one or more adjuncts coupled to the staples and configured to occlude or seal these perforations. As noted above, the adjunct can be formed from an adhesive coating (e.g., bioabsorbable polyurethane, etc.) disposed in the staple cavities of the cartridge body containing the staples. Upon ejection from the cartridge body, the secondary cover can become a plug that fills the perforations 4008,4010 formed by the staple legs. The plug may be compressed as the staple is formed through the tissue, and as the adjunct material is compressed, it may expand and fill any defects in the tissue that may form leak paths. The auxiliary plug may also serve to distribute the pressure applied by the staples, reducing the likelihood of the staples pulling through the tissue and failing to fasten the tissue as intended (so-called "cheese-wiring"). In addition, the adhesive cover used as an adjunct material may also include other healing properties as described above (e.g., antimicrobial properties, hemostatic agents, etc.) or other features that aid in forming the staples (e.g., lubricants, etc.).

Fig. 9A illustrates one embodiment of an adjunct 4012 disposed around the legs of a surgical staple 4014. The illustrated adjuncts 4012 are in the form of plugs disposed around each leg of the staple, i.e., they have a tapered cylindrical shape configured to wedge into the perforations formed by the staple legs as they pass through tissue. The adjunct 4012 can be formed at any point along the legs of the staples 4014 and in some embodiments can be configured to slide along the legs, as described in more detail below.

In the embodiment shown in fig. 9B, adjuncts 4016 can be positioned at the junction between crowns 4018 of staples 4014 and each

staple leg

4020,4022. The adjunct 4016 can likewise have a shape that tapers from the crown 4018 toward the distal ends of the

staple legs

4020,4022 such that the adjunct forms a plug that is configured to be received within a perforation in tissue. The adjunct 4016 can also be formed from a flowable material (e.g., a hydrogel) that can retain its shape prior to implantation but can become more flowable after implantation in tissue to fill a puncture or other defect in the tissue. In other embodiments, swellable materials, i.e., materials that increase in volume upon contact with water or other bodily fluids, may be used.

Fig. 10 shows an alternative embodiment of an adjunct 4024 disposed about the legs of staples 4026. In this embodiment, the staples 4026 are contained within staple cavities of a cartridge body 4028 of a surgical stapler. A secondary plug 4024 is disposed around each leg of the staple 4026 at its distal end. In some implementations, the adjunct 4024 can be disposed in a small incision or shelf formed in the cartridge body 4028 (as compared to fig. 12). The adjunct 4024 can be configured to slide over the legs of the staples 4026, as shown in FIG. 11.

In use, as shown in fig. 12, tissue 4030 can be clamped between the cartridge body 4028 and the anvil 4032 and the staples 4026 can be ejected from the cartridge body through the tissue and into the anvil. The adjunct 4024 can abut tissue 4030 and begin to slide over the legs of the staples 4026 as they are ejected from the cartridge body (see fig. 11). Finally, the adjunct 4024 can be ultimately compressed between the tissue 4030 and the crowns of the staples 4018. Because the adjunct 4024 can be formed of a material that becomes flowable upon contact with water or other bodily fluids or under compressive forces, the cylindrical adjunct 4024 shown in FIG. 11 can flow into the perforations in the tissue 4030 as shown in FIG. 12.

Adhesive covers and other flowable or swellable materials may be suitable choices for auxiliary materials as they can accommodate the different forces experienced by tissue at different locations within the body. Fig. 13A and 13B illustrate that such adjunct materials can be used to effectively seal staple leg penetrations that expand inwardly toward one another (as might be the case when the tissue is under compression) and staple leg penetrations that expand outwardly away from one another (as might be the case when the tissue is under tension). By way of example, tissue under tension is typically found in the thoracic cavity, such as lung tissue and/or cardiovascular tissue (fig. 13B), while tissue under compression is typically found outside the thoracic cavity (fig. 13A).

Fig. 14A and 14B provide alternative views of the configuration shown in fig. 13B. The tissue 4034 under tension can cause the staple leg perforations to expand outward from the staples 4036. Thus, a flowable auxiliary plug 4038 in the form of a gel plug disposed around each leg of the staple 4036 can be pushed outward into the perforation by compression between the crown of the staple and the tissue 4034. The gel may seal the inflation perforations, thereby preventing any leakage through the inflation perforations.

9A-14B illustrate a secondary material disposed about the legs of the surgical staple or formed at the inter-joints between the crown and the staple legs of the staple. In an alternative embodiment shown in fig. 15, a secondary material 4040 can be coupled to the outer surface of the staple 4042 at the junction between the crown 4044 and each

staple leg

4046,4048 of the staple. The secondary material 4040 may be a flowable or swellable material, such as a hydrogel, in some embodiments. Such materials may expand outward upon contact with tissue and fill the perforations formed by the

staple legs

4046,4048. The secondary material 4040 in figure 15 is in the shape of a cylindrical plug, however, any of a variety of other shapes are possible. As noted above, other possible shapes may include tapers along the legs of the spikes, or entirely different shapes may be utilized, such as cubes, hexagonal extrudates, and the like.

The shape of the staple 4042 can be modified to accommodate the secondary material 4040, as shown in figure 16. In some embodiments, for example, the right angle corners of the staple 4014 shown in fig. 9A and 9B can be chamfered to provide attachment surfaces for the secondary material 4040. The crowns 4044 of the staple 4042 also have a wider flat shape rather than the cylindrical shaft or square cross-sectional shape of the staple 4014 of figure 9. Further, both the staple 4042 and the secondary material 4040 can be any of a variety of sizes. Figures 17A-17C illustrate embodiments of

staples

4050, 4052, and 4054 having the same width and leg length, but accommodating an increased amount of

adjunct material

4056,4058,4060.

Figures 18A-18C illustrate the implantation of the staple 4042 shown in figure 15 in a patient's lung. The staples 4042 can be initially stored in the staple cavities of the surgical stapler cartridge body 4062. Once the tissue 4064 is disposed between the cartridge body 4062 and the anvil 4066, the staples 4042 can be ejected from the staple cavities, through the tissue, and into the anvil. Upon contact with the lung tissue 4064, the hydrogel adjunct material 4040 can expand to fill any voids or defects surrounding the perforations formed by the

staple legs

4046,4048.

The flat crown staple of fig. 15 is but one embodiment of a staple to which adaptable secondary materials are attached. Fig. 19A and 19B illustrate still other alternative staple geometries that may have a secondary material coupled thereto (e.g., disposed about the legs thereof, or coupled to the outer or inner surface of the crown). Still other staple geometries that may be combined with the adjunct materials disclosed herein are disclosed in U.S. patent application No. 14/138,516 filed on 2013, 12 and 23, which is incorporated herein by reference in its entirety. Regardless of the particular staple geometry or attachment mechanism of the secondary material, the secondary material is able to fill and seal the individual perforations formed by the staple legs.

Fig. 20 illustrates an alternative embodiment of an accessory in the form of a pledget 4066 configured to seal around both the first and second legs of surgical staples 4068. Pledget 4066 is shown pressed against the crown (not shown) of staples 4068 and can be formed from a flowable and/or swellable material, such as a hydrogel or other gel, as discussed above. The gel may be configured to retain its shape when disposed within the surgical stapler cartridge, as shown in FIG. 21A, but become more flowable in all directions upon contact with tissue, water, or other fluid, as shown in FIG. 21B.

Figures 22A and 22B illustrate a surgical staple 4068 and an auxiliary pledget 4066 as viewed from the side, before and after implantation. As shown in fig. 22B, after contact with tissue 4070, pledget 4066 has expanded outward and flowed into tissue 4070. The gel material of pledget 4066 can thereby seal the perforations formed by staples 4068 and distribute the pressure applied to the tissue by crowns 4072 of staples 4068.

In still other embodiments, the adjunct material can be in the form of a cover disposed over all or a portion of the surgical staples, as shown in fig. 23 and 24. In particular, staple 4074 of figure 23 includes a covering 4076 of secondary material disposed over the entire outer surface thereof. The secondary material employed in the cover 4076 can be configured to swell upon contact with tissue or bodily fluids such that the cover will expand away from the staples and fill any voids that may be present once the staples 4074 are implanted in the tissue. Figure 24 illustrates a cross-sectional side view of a tissue 4078 having a plurality of rows of staples 4074 disposed therein. Staples 4074 can seal tissues 4078 together in the center of the figure so that fluid cannot pass and the tissues can be transected between staples 4074.

Other non-flowable materials may also be employed as an aid in some embodiments. For example, a gel or other flowable material may be incorporated or a compressible foam may be used independently as an auxiliary material. Figure 25 illustrates one embodiment of a staple 4080 having a foam adjunct 4082 disposed about both legs of the staple. Attempts to utilize foam in conjunction with staples can sometimes encounter problems with the foam rotating around the crown of the staple during implantation. The staple 4080 solves this problem and minimizes this possibility by incorporating an additional pledget 4084 between the crown of the staple and the foam aid 4082. Pledget 4084 can provide support to foam adjuncts 4082 during implantation to prevent rotation around the crown of the staple. Pledget 4084 can be formed of a rigid biocompatible material, or can be formed of a flowable material as described above. In the latter embodiment, the gel or other flowable material can retain its shape prior to implantation to provide the necessary support for the foam aid 4082 and then flow into the defect in the tissue after implantation. U.S. patent publication No. 2011/0192882 to Hess et al, the entire contents of which are incorporated herein by reference, discloses additional techniques for coupling staples to rigid pledgets and incorporating them into cartridge bodies that can be combined with the adjunct materials disclosed herein.

In some embodiments, it may be desirable to prevent any adjunct material from coming into contact with the cartridge body of the surgical stapler during implantation of the staples. If there is contact between the cartridge body and the adjunct, it is possible that the adjunct material can be scraped from the staples as they are ejected from the cartridge body. In embodiments in which the adjunct material is a hydrogel or other flowable and/or swellable material, it is also possible that the adjunct material can interfere with staple ejection if the adjunct material is, for example, scraped into the staple cartridge and expanded there or flowed into adjacent portions of the surgical stapler. Thus, in certain embodiments, a sealing adjunct disposed within a staple cavity of a surgical stapler cartridge body can be configured to be ejected from the staple cavity along with staples without contacting the cartridge body.

There are a variety of ways to ensure that the adjunct does not contact the cartridge body. In one embodiment, the adjunct material can be coupled to the staples such that the staples protect the adjunct from contact with the cartridge body during ejection. The staples illustrated in fig. 15 are one embodiment of staples that protect the adjunct material from contact with the cartridge body because the adjunct material is substantially behind the staples as the staples are ejected from the cartridge body. In other embodiments, the secondary material may be packed into the area extending between the legs of the staple, such as in the staple shown in fig. 9B. This configuration can also protect the adjunct material from contacting the cartridge body during ejection from the staple cavities.

In other embodiments, the staple cavity openings in the cartridge body can be shaped to accommodate the passage of at least one sealing adjunct coupled to the surgical staples. Figure 26 illustrates one embodiment of a cartridge body 4086 comprising a plurality of staple cavities 4088 which are shaped to accommodate the openings of the staples 4080 and foam adjuncts 4082 illustrated in figure 25.

Fig. 27 illustrates an alternative embodiment of a cartridge body 4090 having a plurality of staple cavities 4092 shaped to accommodate staples 4094 having a plurality of adjuncts 4096 coupled to an outer portion of each staple leg. 28A-28C illustrate various embodiments of staple cavity openings configured to allow passage of one or more accessories coupled to a surgical staple. In the top view of fig. 28A, for example, the deck 4098 of the cartridge body is shown having openings 4100 formed therein. The opening 4100 may include cutouts 4102,4104 formed at opposite ends thereof that are sized to accommodate a

seal aid

4106,4108 coupled to flat spikes 4110 similar to the spikes shown in fig. 15. In an alternative embodiment of fig. 28B and 28C, additional cuts are provided around the legs of the spike 4110 to accommodate different configurations of the secondary material coupled thereto.

Anvil side-segmenting auxiliary part

Certain embodiments of the methods and devices described herein include one or more adjunct segments disposed on an anvil side of a surgical stapler (i.e., on an opposite side of the staple tissue from the crown-side adjunct described above). These anvil-side aids may be used in addition to the crown-side aids. While the crown-side adjunct serves to prevent leakage caused by tissue deformation around the staple legs, the anvil-side adjunct described below can prevent tissue damage from strain caused by the staples and staple lines as a whole.

Adjunct segments disposed on the anvil side of a surgical stapler can include a sheet of biocompatible or bioabsorbable material, separate adjunct segments each designed to interact with a leg of a single staple, separate adjunct segments each designed to interact with a leg of a plurality of staples, separate adjunct segments attached to one another, or any suitable combination thereof. In some embodiments, each adjunct can have a size such that each adjunct spans only a single staple forming opening when placed adjacent an anvil side of a surgical stapler. Additionally, in some embodiments, each adjunct can have a size such that each adjunct spans a plurality of staple forming openings when placed adjacent an anvil side of a surgical stapler.

In addition to preventing damage from staples in the stapled tissue, adjunct segments disposed on the anvil side of the surgical stapler can be used to hold together staples that do not interact with the tissue (i.e., excess staples) during the stapling procedure. For example, in embodiments in which the anvil-side adjunct comprises a sheet of material, adjunct segments each designed to interact with a leg of a plurality of staples, or adjunct segments attached to each other, the surgical stapler can be fitted across a tissue segment (such as intestinal tissue or a portion of a vessel) whose diameter is shorter than the length of the staple line formed by the surgical stapler. In that case, there will be staples that do not penetrate the tissue. Removal of those excess staples from the patient is made more convenient if those excess staples that are not tissue-fixed remain attached to the tissue by the adjunct segments. The surgeon or stapler operator may then sever selected adjuncts to separate the excess staples and he or she may remove all of these excess staples while minimizing the likelihood of the excess staples being lost in the patient.

Although some embodiments of the segmented adjunct described herein can be used on a cartridge, as described in more detail below, adjunct segments can be deposited as a liquid that hardens over time or after exposure to curing radiation to the anvil side of a surgical stapler in a staple forming recess located in the anvil side of the surgical stapler. The auxiliary may also be supplied as a separate auxiliary attached to the sheet. The sheet may be a connecting film, such as a continuous film. The sheet may be a woven mesh. In some embodiments, a plurality of separate adjuncts may be connected by a plurality of connecting branches, by a plurality of wires, or other suitable means for connecting the adjuncts to biocompatible or bioabsorbable materials that do not interfere with the operation of the staples or stimulate tissue once the staples are applied. When the adjuncts used are connected by a plurality of connecting branches, the surgical stapler can include one or more features for severing the connecting branches as the staples are deployed into tissue.

Fig. 29 illustrates a top view of an embodiment of a plurality of adjunct segments 4112 coupled to one another, such as may be disposed in a cartridge used with or directly in a surgical stapler. A single adjunct segment 4114 is shown spanning multiple staple forming openings 4116, and when applied to tissue, as seen in the top portion of the right hand figure, there may be an excess of adjunct segments 4120 not attached to the tissue. The individual auxiliary piece segments 4114 are connected together by branches 4118. Branch 4118 may be made of a similar material as the auxiliary piece, but may be made thinner than the auxiliary piece and have a diameter 4122 that allows branch 4118 to be broken off by the application of force. In this manner, the excess adjunct segment 4120 can be removed.

Fig. 30 shows a perspective view of an alternative embodiment of a plurality of adjunct segments 4124 applied to the anvil side of a surgical stapler. The plurality of adjunct segments 4124 shown are held together by a thread 4126 connecting the filaments 4128 between the individual adjunct segments 4128. Each adjunct segment 4128 is configured to span a plurality of staple forming openings 4132.

The membrane, which may include the woven material 4130, may overlap the single segmented adjunct 4128. The membrane, optionally including the woven material 4130, may mitigate damage to the suture tissue by distributing forces.

Fig. 31A illustrates a view of one embodiment of a surgical end effector 4134 having a plurality of adjunct segments 4124. The surgical end effector 4134 is shown receiving a vessel 4136. In fig. 31B, the surgical end effector 4134 is shown transecting the vessel 4136, thereby engaging the staples with the adjunct segment 4124 of fig. 31A. Figure 31C shows the vessel 4136 and the adjunct 4124 after transecting the vessel 4136. The filament or wire 4126 can connect the adjunct 4124, and the filament or wire 4126 can assist in applying the plurality of adjuncts 4124 to the surgical end effector 4134. And the filament or thread 4126 may be torn when separating the ends of the transected vessel 4136. The filament or wire 4126 may hold the excess adjunct segment 4138 in place until removed by the surgeon.

FIG. 32 illustrates another embodiment of a staging aid 4140 disposed on the anvil side of a surgical stapler 4142. Each

individual adjunct segment

4144,4146 spans multiple staple forming openings. As shown, each

accessory segment

4144,4146 may have a configuration that is different from the configuration of the accessory segment adjacent thereto. However, each

accessory segment

4144,4146 interlocks with its neighbors. In this manner, there may be some degree of adhesion between adjacent

adjunct segments

4144,4146 such that no filaments or branches are needed and such that no filaments or portions of branches will be exposed after removal of excess adjunct segments from the stapled tissue. Additionally, the auxiliary element is shown as comprising a woven material.

Fig. 33 shows a portion of a surgical anvil housing 4148 having a plurality of staple forming openings filled with a viscous sealant material 4150. Some of the manner in which material reaches the staple forming openings of the anvil block 4148 is shown in fig. 34-36D. Fig. 34 illustrates a surgical stapler anvil 4152 having staple forming openings in which preformed sealing gel 4154 is placed, as described in more detail below. FIG. 35 is a cross-sectional view of an anvil 4156 having staple forming openings filled with a sealing liquid or gel 4158. The sealing liquid or gel 4158 has a film or layer 4160 above the body of sealing material that is flush with the surface of the anvil 4156. FIG. 36A shows the addition of a sealing material 4158 in a liquid or gel state to the staple forming openings on the anvil 4156. Fig. 36B shows the staple forming openings filled with a sealing liquid or gel, and fig. 36C shows the formation of a film or layer 4160. A light source, such as an ultraviolet light source, provides light at an energy level sufficient to partially cure the sealing material 4158 to form the film or layer 4160.

In some embodiments, the staple forming openings of the anvil can comprise a fully cured sealing material 4162, as shown in fig. 36D. The fully cured sealing material 4162 may have different material properties than the partially cured material shown in fig. 35A. FIG. 37 shows staples 4164 formed using a surgical stapler with partially cured sealing material in staple forming openings of a stapler anvil. The staples 4164 have legs that pass through the cured layer 4160, into the uncured sealing material 4158, and back through the cured layer 4160, and in some embodiments, the end of each leg of the staple 4164 may terminate in the tissue. The sealing material helps prevent any fluid from passing through the tissue adjacent to the staples and from undesired deformation or damage to the tissue.

Fig. 38 illustrates an alternative approach for delivering an adjunct on the anvil side of a surgical staple 4166 that includes a thin connecting membrane 4170 and a plurality of adjuncts 4168 that fit into staple forming openings on the anvil of a surgical stapler. The thin connecting film 4170 may be a continuous film that makes it easy to carry and place a plurality of the auxiliary members 4168 at one time.

Fig. 39 is a perspective view showing the auxiliary member 4172 having the net-like material 4174. Fig. 40 is an exploded view of the view of fig. 39. Fig. 41A and 41B show the auxiliary 4184 solidified with the film over the auxiliary 4186 (wherein the film connects the auxiliary 4186), and separate auxiliary 4190 not connected to each other. In the system of independent adjuncts 4188, each adjunct 4190 has uncured sealing material that fits within the staple forming openings of the anvil of the surgical stapler. Each of the auxiliaries also has a layer of cured material 4194 over the uncured sealing material 4192.

FIG. 42 illustrates a cross-sectional view of the surgical staples 4198 in the cartridge 4196 opposite the anvil 4202 of the surgical stapler. In the figure, the tissue 4200 is between the cartridge 4196 and the anvil 4202. The anvil 4202 is shown having a plurality of staple forming openings 4190, each filled with uncured sealing material 4192 and having a layer of cured sealing material 4194 over each staple forming opening 4190.

Fig. 43 is a cross-sectional view of a surgical staple 4198 inserted into tissue 4200 with an adjunct comprising both cured and uncured sealing material present on the free ends of the legs of the staple. The legs of the staple have passed through the tissue, through the cured portion of the adjunct material 4204, through a portion of the uncured adjunct material 4206, and then back into the tissue 4200. FIG. 44 illustrates curing the uncured secondary material 4206 of FIG. 43 into a cured conformable material 4210. The light source 4208 provides suitable radiation to cure the liquid or gel setting material 4206 after the material has been spread to conform to the surface of the tissue 4200.

Fig. 45 shows a grouping 4212 of individual auxiliary piece segments 4214 connected by a plurality of auxiliary material connection branches 4216. The adjunct segments 4214 in a grouping 4212 can be partially cured or fully cured such that the grouping 4212 can store a long period of time. Fig. 46 illustrates the adjunct component 4212 of fig. 45 assembled over staple forming openings or anvil pockets 4220 on a surgical stapler anvil 4218.

Fig. 47 illustrates the anvil 4222 having adjunct separation features 4226 located between the staple forming openings 4224. Fig. 48 illustrates a side view of an embodiment of a surgical stapler including staples 4228 in a staple cartridge 4230 and a plurality of adjunct segments 4214 coupled to an anvil 4222. A plurality of accessory segments 4214 are connected by branches 4216. When the staples 4228 are inserted into tissue (4232 in fig. 49), the branches 4216 are severed by the sharp features 4216. Fig. 49 shows the staple 4228 as it is formed by actuating the surgical staple, and fig. 50 shows the staple 4228 after it has been fully implanted in tissue 4232, wherein the branches 4216 are severed, thereby creating breaks 4234 in the branches, and wherein the adjunct segments 4214 are located between a portion of the ends of the legs of the staple 4228 and the tissue 4232.

Fig. 51 is a cross-sectional view of an embodiment of a retainer 4238 for retaining a adjunct material 4240 in position against a surgical stapler anvil 4236. Fig. 52A is a cross-sectional view of the retention 4238 and anvil 4236 shown in fig. 51, with the adjunct material 4240 positioned between the anvil and the retainer. Fig. 52B is a variation of the embodiment shown in fig. 52A in which the secondary material is present only as a separate secondary element 4240 without any connecting material.

FIG. 53 is a cross-sectional view of an embodiment of a staple forming opening 4246 having raised tabs 4244. The tabs 4244 are shaped during manufacture into the retainer feature. Fig. 54 shows the staple forming opening 4246 of fig. 53 filled with a plug element 4250 or secondary material, and a raised tab 4244 shaped to capture a feature 4248. FIG. 55 is a top view of the staple forming opening 4246 shown in FIG. 53. Line a-a is the line along which these cross-sectional views are taken.

FIG. 56 shows a perspective view of one embodiment of a surgical stapler having

adjunct segments

4256,4258 associated with both the anvil 4254 and the staple cartridge 4252. In this embodiment, the adjunct segments 4258 on the anvil 4254 have adjunct material branches or filaments 4260 located between the adjunct segments 4258. The adjunct segments 4256 on the staple cartridge 4252 interlock with each other such that the recess 4262 in one adjunct segment receives the protrusion 4264 from its adjacent adjunct segment. In this way, additional means of holding together the adjuncts 4256 on the staple cartridge 4252 on the crown side of the staples are required. In addition, the adjunct 4256 on the staple cartridge 4252 spans more than one staple such that two or more staples will be connected by each adjunct.

Fig. 57 and 58 illustrate an embodiment of a surgical stapler having an anvil 4266 including an attachment feature 4272 and an alignment feature 4274 for a secondary material 4270. Fig. 57 is an exploded view of an anvil 4266 having staple forming openings 4268 and features 4274 on its sides for anchoring or interfacing with a collar 4272 on a sheet of secondary material 4270. Fig. 58 shows the secondary material 4270 flush against an anvil 4266 having a collar 4272 attached to a feature 4274, shown as a tab or peg attached to the collar. These features 4274 may be present on the staple cartridge and used with similar types of adjunct materials instead of or in addition to the anvil 4266 for the surgical stapler.

Fig. 59-61 illustrate an embodiment of a surgical stapler 4276 having a

adjunct assembly

4284,4278 that is coupled to both an anvil 4282 and a staple cartridge 4280 of the stapler. The

adjunct assembly

4284,4278 is shown to include

adjunct segments

4286,4288 connected by a sheet of adjunct material. On the anvil 4282, there are a plurality of staple forming openings 4290 that can receive the adjunct segments 4286. Fig. 61 shows the thickness of the accessory segment 4286 relative to the piece of accessory material. The adjunct segments 4286 on the stapler anvil 4282 can comprise partially cured or fully cured sealing material, as described above. The adjunct material 4278 for use with the staple cartridge 4280 has adjunct segments 4288 that can fit over the ends of the staples in the cartridge 4280 (in contact with or over the staple legs). Indeed, use of such a surgical stapler 4276 would insert the staples into the tissue along with the adjunct material at the crown of each staple and at the anvil side of each staple, potentially reducing leakage and tissue damage caused by the staples.

Fig. 62 illustrates a cross-sectional view of one embodiment of a plurality of adjunct segments 4288 (e.g., micro-fingers) connected to one another by a membrane 4278. These adjunct segments 4288 can not correspond to a single feature on a stapler anvil or staple cartridge, but can be used to act as a cushion or a lightweight, highly conformable and compressible material. FIGS. 63A and 63B illustrate cross-sectional views of a surgical stapler similar to that illustrated in FIG. 59, wherein the staples 4294 in the cartridge 4292 comprise a adjunct material 4296 comprising a plurality of adjunct segments 4292 which can serve as a lightweight, conformable and compressible material 4296. The anvil 4300 shown in FIG. 63A has staple forming openings 4302 therein that include a adjunct segment 4304 attached to a sheet of adjunct material 4306. Fig. 63B shows the staples 4294 after they have been actuated on the tissue 4308. The tissue 4308 contacts the adjunct material through the micro-fingers 4298 near the crown of the staple and the thicker continuous adjunct material 4304 on the anvil side of the staple.

FIGS. 64A and 64B illustrate an embodiment of a surgical stapler component 4310 including adjunct segments 4312 of different thicknesses. Each adjunct segment is independent and spans only one staple. FIG. 64B shows that the larger thickness adjunct segment 4318 is positioned closest to the centerline of the stapler component 4310, and the thinner adjunct segment 4316 corresponds to a staple further from the centerline where a cut will be made in the stapled tissue.

FIG. 65 shows another embodiment of an

adjunct segment

4322,4326 positioned on a portion of a surgical stapler. The

aide segments

4322,4324 do not have a uniform thickness. Each of the adjunct segments has a

thick side

4328,4330 and a

thin side

4332,4334. Each

adjunct segment

4322,4324 spans more than one staple 4326 location shown in the exemplary staple cartridge 4320. The adjunct segment is shown with its

thick side

4328,4330 toward the center of the staple cartridge 4320. When the surgical stapler cuts through tissue after stapling the tissue, the surgical stapler will cut the tissue through the center of the cartridge between the

thick sides

4328,4330 of the adjunct segments. In this manner, the

adjunct segments

4322,4324 provide more support to the staples closest to the free end of the tissue.

FIG. 66 shows a cross-sectional view of the stapler of FIG. 65. The staple cartridge 4320 holds staples 4336. The

adjunct segments

4334 and 4324 above the staples 4336 which are the outermost staples, have their

thick side

4330,4328 near the center of the cartridge and their

thin side

4324,4322 toward the outer edge of the cartridge 4320. The stapler anvil 4338 has staple forming openings 4340 over which

adjunct segments

4342,4344 are placed. Anvil side

adjunct segments

4342,4344 are shown with their

thick side

4346,4348 adjacent to the bulged portion of the anvil corresponding to the innermost staple. The

thin side

4350,4352 of the

anvil side adjuncts

4342,4344 is positioned towards the edge of the anvil such that it is associated with the outermost staple once the stapler is actuated.

FIG. 67 shows an embodiment of a surgical stapler component 4310 including adjunct segments 4312 of different thicknesses. Each adjunct segment is independent and spans only one staple. The greater thickness adjunct segment 4318 is positioned closest to the centerline of the stapler component 4310, and the thinner adjunct segment 4316 corresponds to a staple further from the centerline where an incision will be made in the stapled tissue. These auxiliary piece segments are separate rather than interlocking as shown in fig. 65.

Fig. 68A and 68B illustrate a multi-material accessory 4354 including a membrane 4356 having openings 4360 and a base layer 4358 having connection features 4362. The base layer 4358 may be a layer of elastomeric material. The connection features 4362 may be shaped to fit through the openings 4360, for example, the connection features 4362 shown are posts and the openings 4360 are circular holes. The connection features 4362 and openings 4360 may be any suitable shape, symmetric or asymmetric, as when a particular orientation between the base layer 4358 and the membrane 4356 is desired. Fig. 69A and 69B illustrate the accessory of fig. 68A and 68B in context with the peg 4364 shown. Fig. 69A shows the staple prior to insertion into the aide 4354. The staples 4364 are shown aligned with the connection features 4362 such that each leg of the staple moves through the connection features 4362 when stapling tissue. FIG. 69B shows staples 4364 after they have been moved toward the anvil of the surgical stapler.

Fig. 70-72 illustrate various embodiments of surgical staples and adjuncts in tissue wherein the legs of the surgical staples are shaped to hold the tissue in a particular configuration. Fig. 70 shows staples 4368 in tissue 4370, wherein the secondary material 4372 is proximate the anvil side of the staples such that the secondary material 4372 acts as a seal to avoid leakage from the tissue 4368. FIG. 71 shows staples 4374 in tissue 4376 with adjuncts on the anvil side of the staples 4374. The adjuncts include a membrane 4378, a recess 4382 in the membrane, and a thicker region in adjunct 4380 into which the end of the leg of the staple moves when the staple 4374 is formed. In FIG. 72, a staple 4374 is used with an adjunct having a membrane 4378, a plurality of recesses of each staple 4386 in the membrane, and a pair of thicker regions of the adjunct 4380 (a pair of thicker regions of each staple) into which the ends of the legs of the staple move when the staple 4374 is formed.

Fig. 73A-73E illustrate different embodiments of a plurality of adjuncts coupled to a surgical stapler anvil. The adjunct array 4388 shown in fig. 73A includes a portion proximate to an anvil edge 4392, a portion proximate to an anvil centerline 4390, and a plurality of adjunct segments 4394. The illustrated adjunct segments include openings 4400 for the staple legs to pass through as they move toward the anvil and openings 4402 for the staple legs to pass through as they move away from the anvil during staple formation. The adjunct segments 4394 are connected to each other and to portions of the adjunct array proximate the anvil edge 4392 and the anvil centerline 4390 by adjunct material branches 4398. The edge 4392 and centerline 4390 portions also have branches 4396 for connection to the accessory segments 4394. Fig. 73B shows an auxiliary component assembly 4404 similar to the auxiliary component assembly shown in fig. 73A. The adjunct array 4404 illustrated in fig. 73B includes a portion proximate to the anvil edge 4392, a portion proximate to the anvil centerline 4390, and a plurality of adjunct segments 4408. The illustrated adjunct segment includes openings 4412 for the staple legs to pass through as they move toward the anvil and openings 4414 for the staple legs to pass through as they move away from the anvil during staple formation. The adjunct segments 4408 are coupled to each other and to portions of the adjunct array proximate the anvil edge 4392 and the anvil centerline 4390 by the adjunct material branches 4406. Unlike the aide array 4388 of fig. 73A, the aide array 4404 has no connectors between rows of aide segments. The accessory array 4416 of fig. 73C is similar to the accessory array of fig. 73B in that there are no connectors between the rows of accessory segments, only connectors 4420 between each accessory segment 4418 and its adjacent segment. Each segment has openings 4422 for the staple legs to pass through as they move toward the anvil and openings 4424 for the staple legs to pass through as they move away from the anvil during staple formation. The adjunct array 4426 illustrated in fig. 73D comprises a portion proximate to the anvil edge 4428, a portion proximate to the anvil centerline 4430, and a plurality of adjunct segments 4432. The illustrated adjunct segment includes openings 4438 for the staple legs to pass through as they move toward the anvil and openings 4440 for the staple legs to pass through as they move away from the anvil during staple formation. Adjunct segments 4432 are connected to each other and to portions of the adjunct array proximate anvil edge 4428 and anvil centerline 4430 by

adjunct material branch

4434,4436. The adjunct array 4442 illustrated in fig. 73E differs from the adjunct array illustrated in fig. 73D and includes a portion proximate to an anvil edge 4444, a portion proximate to an anvil centerline 4446, and a plurality of adjunct segments 4452. The illustrated adjunct segment includes openings 4458 for the staple legs to pass through as they move toward the anvil and openings 4456 for the staple legs to pass through as they move away from the anvil during staple formation. Adjunct segments 4452 are connected to each other and to portions of the adjunct array proximate anvil edge 4444 and anvil centerline 4446 by adjunct material branch 4448,4454,4450.

Fig. 74 shows a first side 4460 and a second side 4470 of a plurality of auxiliary members 4464 connected in a row. The first side view 4460 shows the adjunct segment 4464, its connector 4462, openings 4466 in the adjunct segment for when the legs move toward the stapler anvil during staple formation, and openings 4468 in the adjunct segment for when the legs move away from the stapler anvil during staple formation. The second side view 4470 shows the elements of the first side view 4460, but there is additional material on this side of the auxiliary 4464. Through this additional material, there are openings 4474 in the adjunct segments for when the legs move toward the stapler anvil during staple formation, and openings 4472 in the adjunct segments for when the legs move away from the stapler anvil during staple formation.

Fig. 75-79 illustrate embodiments of adjunct segments that overlap and interlock to some extent when used with surgical staples. The illustrated configuration can be used to accommodate movement in tissue, such as expansion upon contraction after suturing. In fig. 75, there are two configurations of

adjunct segments

4512,4514. The

accessory segments

4512,4514 are shown as mirror images of each other. Each of the adjunct segments spans two of the staples. For example, as in fig. 77, each adjunct segment is shown with two staple crowns in contact with each segment. It should be noted, however, that in the configuration shown in fig. 76 and 77, each staple (except for the staples at the ends of the rows) contacts two overlapping adjunct segments. In fig. 76, the two

adjunct segments

4512 and 4514 are seen in an extended configuration 4526 and in a compact configuration 4528. The openings are shown in the adjunct segments through which the staple legs pass as the staples are formed in the surgical stapler by movement from the staple cartridge toward the anvil. As can be seen, when the

adjuncts

4512,4514 are overlaid, some of the openings overlap and align to allow the staple legs to pass through. Opening 4516 is aligned with opening 4522 and opening 4520 is aligned with opening 4518 at the bottom of the aide segment. Opening 4518 is shown as not being aligned with any other opening, but opening 4518 may be aligned with opening 4525 of another aide segment similar to 4512. Similarly, opening 4524 is not shown as being aligned with any other opening, but it may be aligned with opening 4516 of another aide segment similar to 4512. Fig. 76 shows that in the extended configuration 4526, adjacent openings on the top portions of the

aide segments

4525 and 4524 are farther apart than in the compact configuration 4528. Fig. 78 shows the relative positions of two adjacent aide segments 4514 that are similarly oriented. In the extended configuration 4526, there are gaps or spaces between the adjunct segments 4514. In compact configuration 4528, adjacent adjunct segments 4514 are in close proximity, in some cases in contact, and in some cases overlap slightly. Fig. 79 illustrates a compact configuration 4528 in which only half of the aide segments are visible (such as when the aide segments are opaque and only the uppermost aide segment is visible).

80A-80C illustrate an embodiment of an adjunct segment connecting adjacent surgical staples. Fig. 80A shows a row 4530 of surgical staples 4532 which are connected to the next staple in the row by an adjunct segment 4534. Adjunct segment 4534 is shown in or on a support layer or film 4536. Such configurations, adjunct segments with support layers or films are described in more detail elsewhere herein. Once the staples are deployed in tissue, adjunct segment 4534, shown in fig. 80A, is positioned adjacent to the anvil side of the staples. Fig. 80B shows a row 4540 of surgical staples 4542 in use with an adjunct segment 4544 and a support membrane 4546. As in fig. 80A, adjunct segments 4544 are positioned adjacent to the anvil side of staples 4542. However, the shapes of the adjunct segments 4544 of fig. 80B differ from those of fig. 80A in that the openings for receiving the staple legs are larger in fig. 80B. This increased size may allow for slight contraction or expansion of the tissue and corresponding movement of the staples. Fig. 80C illustrates another embodiment in which rows 4550 of surgical staples 4552 are used with adjunct segments 4554 and a support membrane 4556. The adjunct segment 4554 in fig. 80C differs from the adjunct segment 4554 in fig. 80A and 80B in that the adjunct segment 4554 is a loop, thereby allowing the maximum amount of movement of the staple legs within the center 4558 of the adjunct segment 4554. This allows for even greater movement of each surgical staple relative to its neighbors, and thus the stapled tissue can accommodate greater expansion and contraction.

Fig. 81 and 82 illustrate the adjunct segment 4534 and surgical staples 4532 of fig. 80A. In fig. 81, artery 4560 has staples 4532 and adjunct segments 4543 seal a portion of artery 4562. Fig. 82 shows an artery 4560, a staple 4532, and an adjunct 4534. In both fig. 81 and 82, each staple 4532 is shown connected to its neighbor by opposite ends of an adjunct segment.

FIGS. 83-85 are similar to FIG. 81, except that each figure illustrates a different type or use of an auxiliary piece segment. In fig. 83, an artery or other type of tissue 4560 is sealed by two rows 4570 of staples 4572. The row of surgical staples 4572 at the free edge of tissue 4562 has a thick adjunct segment 4574. The row of surgical staples 4572 further from the free edge of tissue 4562 has thinner adjunct segments 4576.

Adjunct segment

4574,4576 connects each surgical staple 4572 to at least one adjacent staple. Additionally, when the staples are deployed,

adjunct segments

4574,4576 are adjacent the crowns of staples 4579, as shown. The use of different thicknesses of

adjunct segments

4574,4576 can help prevent tissue damage and can help promote healing of tissue 4560 following a suturing procedure. The embodiment of the row of staples 4580 illustrated in fig. 84 is similar to the embodiment illustrated in fig. 83 except that

adjunct segments

4584,4586 are positioned adjacent anvil side portions 4588 of surgical staples 4582. The thickness of the

adjunct segments

4584,4586 differs because those closest to the free edge 4562 of the tissue are thicker adjunct segments 4584 and those further from the free edge are thinner adjunct segments 4586. Fig. 85 illustrates an embodiment of rows 4590 of surgical staples 4592 wherein

thicker adjuncts

4594,4595 are used closer to the free edge 4562 of tissue 4560 and thinner adjuncts are used further from the free edge 4562 of tissue 4560 to attach each staple 4592 to an adjacent staple along the length of the row 4590. In the embodiment shown in fig. 85,

adjuncts

4594,4595,4596,4597 are positioned adjacent to crowns 4599 of staples 4592 and adjacent to anvil side portions 4598 of staples 4592.

Staple lines comprising a plurality of surgical staples and adjunct segments connecting two surgical staples together can assume a myriad of configurations corresponding to the range of contraction or expansion of the underlying tissue. Fig. 86-89 illustrate exemplary configurations of adjunct segments and surgical staples, wherein each staple connects two adjunct segments. FIG. 86 shows a staple cartridge 4600 with adjunct segments 4604 that contact two staples 4602 when forming staple lines. The staple line includes two rows of staples applied in parallel with the surgical incision, with a first row adjacent to the surgical incision and a second row further from the surgical incision. The staples in the first row are offset from the second row. Each adjunct segment 4604 connects staples from a first row with staples from a second row. Due to this deviation, the adjunct segments 4606 are applied in a position that is oblique compared to a line perpendicular to the surgical incision, and in the relaxed state, as shown, the adjunct segments 4616 are close together because they may be touching or nearly touching. Figure 89 illustrates the progression of the configuration change from the tensioned state 4620 to the fully relaxed state 4630. In the extreme tension state 4620, the auxiliary piece segments 4616 are in a particular position at an angle in the range of about 0 ° to 90 ° such that the auxiliary piece segments 4616 are farther away from each other than in the relaxed state 4630. In the neutral position 4625 shown in fig. 89, the auxiliary element segment 4616 is perpendicular to the surgical incision. The relaxed state 4630 is similar to the relaxed state shown in figure 86.

Fig. 87 shows another configuration of adjunct segments 4608 and surgical staples 4606, wherein the staples are applied at an angle along a surgical incision. In the relaxed state 4610, e.g., when first applied to tissue, the staples 4606 are at an angle of between about 0 ° and 90 ° relative to the incision, e.g., about 45 ° relative to the incision, and the adjunct segments 4608 are perpendicular to the incision. As the tissue stretches, the staples 4606 are at different angles, such as about 30 ° relative to the incision. The adjunct segments 4608 move from a position substantially perpendicular to the surgical incision to a position that is no longer perpendicular. Fig. 88A shows a side view of the relaxed configuration 4610 and fig. 88B shows a side view of the tensioned configuration 4612 of the staples 4606 and the adjunct segments 4608.

Figures 90A-90B illustrate an embodiment 4640 of a surgical staple and accessory segment 4652 connected by a serpentine connector 4646 on an optional support layer 4642. The support layer 4642 may also include unconnected accessory segments 4644. The snake 4646 is connected to the accessory segment 4652 at a connection point 4648. The illustrated support and assist piece segment 4652 includes openings for the staple legs.

As shown in the other figures described above, the adjunct segments can have a number of configurations. Fig. 91A-95D show four different configurations. Fig. 91A-91D illustrate an accessory segment 4690 that is symmetrical such that the top and bottom views are similar. The accessory segments 4690 include openings 4692 for the staple legs. Fig. 91A is a cross-sectional view of an accessory segment 4690, fig. 91B is an end view of an accessory segment, fig. 91C is a bottom view of an accessory segment 4690, and fig. 91D is a top perspective view of an accessory segment 4690. Fig. 92A-92D show an adjunct segment 4700 that includes a thicker portion 4704 in the center of the adjunct segment between openings 4702 for the staple legs.

Fig. 93 illustrates an embodiment of a delivery configuration component 4710 for an adjunct segment 4712. The adjunct segments 4712 can be made as a single component, not connected by branches or filaments, adhered to a compliant or removable backing 4714. The arrangement of adjunct segments 4712 on backings 4714 can be such that mating delivery configuration assembly 4710 with a surgical stapler anvil or staple cartridge allows for perfect or near perfect alignment of adjunct segments 4712 with stapler features.

Fig. 94A-94D illustrate an embodiment of an accessory segment 4715 having a base portion 4717 including an opening 4718 and a thicker portion 4716. Opening 4718 passes through thicker portion 4716 and base portion 4717. The thicker portion 4716 may be a different material than the base portion 4717 or the thicker portion and the base portion may be of the same or similar materials. The thicker portions 4716 can prevent tissue damage from the staple legs as the tissue expands or contracts. Fig. 95A-95D show an adjunct segment 4720 having a base portion 4722 including an opening 4726 for a staple leg and a portion around the opening 4724. The portion of the opening surrounding the opening 4724 can be of a different material than the base portion 4722, or the base portion 4722 and the portion surrounding the opening 4726 can be of the same material, but with different material properties due to their configuration, such as they can act as a cushion between the adjunct segment 4720 and the surgical staples or tissue.

Application of auxiliary materials

Instead of being applied as an adjunct segment, the sealant material can be applied as a film or liquid directly to the tissue being treated by the surgical staples either before or after treatment by the surgical stapler and endocutter.

Fig. 96-99C illustrate an applicator for applying a liquid or gel adjunct material 4899 directly to an anvil or staple cartridge of a surgical stapler 4891. Fig. 96 shows an embodiment 4890 in which an adjunct material 4899 is applied from a tube 4896 by an applicator 4897 attached to the tube 4896. An auxiliary material 4899 is shown on anvil 4892. FIG. 97 illustrates a cross-sectional view of an applicator 4897 having a gel assist material 4894 in contact with an anvil 4892 to fill the staple forming openings 4893. FIG. 98 shows a view of an applicator 4897 having a scraper feature 4898 for applying a secondary material 4894 to an anvil 4892 to fill staple forming openings 4893 with the secondary material. Fig. 99A illustrates an applicator 4909 for applying a adjunct material 4906 from a reservoir 4908 to an anvil 4904 of a surgical stapler 4900. Fig. 99B illustrates an alternative form of applicator 4920 for applying a adjunct material 4922 to an anvil 4914 of a surgical stapler 4910. The applied adjunct material 4922 is troweled into the staple forming openings 4916 by an applicator 4920 to form an adjunct 4918. Fig. 99C shows the adjunct 4918 positioned in the staple forming opening 4916 in the anvil 4914.

FIG. 100-104 illustrate an applicator for applying a secondary material directly to the anvil of a surgical stapler wherein the material is comprised of two precursors or two materials that are mixed prior to application to the anvil or staple cartridge. Fig. 100 illustrates an embodiment 4930 of an applicator 4942 for an adjunct material composed of two materials 4936,4940. The applicator 4942 includes a dual syringe kit 4932 and a mixing nozzle 4944. The dual syringe kit 4932 includes a

single syringe

4934,4938 that interfaces with an applicator nozzle 4946 through a fitting, such as a luer fitting or a threaded fitting. A single syringe is shown as syringe a 4934 that may contain a first material 4936 (such as fibrin) and syringe B4938 that may contain a second material 4940 (such as thrombin). The single plunger discharges the first material and the second material into the mixing nozzle 4994 before the adjunct material exits through the applicator nozzle 4946. Fig. 101 is a similar embodiment, but with the syringes 4952,4954 in syringe kit 4950 being of different diameters such that after administration of the plunger, a ratio of 1: the ratio of materials other than 1 exit the syringe and mix in the common lumen (mixing nozzle 4958) before exiting through applicator nozzle 4959.

Fig. 102A and 102B illustrate a junction between a syringe or other container 4960 filled with a secondary material 4962 and a portion of a mixing or applicator nozzle 4963. The joint includes a fitting between a threaded portion 4966 of the container 4960 of the auxiliary material 4962 and a threaded portion 4965 of the nozzle 4963. The container 4960 of the secondary material 4962 may include a seal 4961 that retains the secondary material 4962 within the container 4960 during transport and storage. Nozzle 4963 includes a puncture feature 4964 to break seal 4961 when

threads

4965 and 4966 are fully engaged. When

threads

4965 and 4966 are fully engaged, secondary material 4962 flows from vessel 4960 into nozzle 4963. Fig. 103 and 104 illustrate a dual syringe kit 4932 attached to a mixing nozzle 4944 and an applicator nozzle 4946, as in fig. 100 for applying an adjunct material 4969 to an anvil 4968 of a surgical stapler 4967.

FIG. 105-110 illustrate a fitting that can apply a liquid or gel to a portion of a surgical stapler (anvil or staple cartridge) and the resulting auxiliary layer. In fig. 105 and 106, the applicator nozzle 4977 is shown as being fitted over the anvil 4976. In fig. 105, the adjunct material 4978 is a single adjunct material, i.e., it is not a material that needs to be mixed just prior to application. The adjunct material 4979 shown in fig. 106 includes two precursors or components that are mixed just prior to application of the adjunct material to the anvil. Fig. 107 shows an anvil 4980 having staple forming openings 4981 filled with a secondary material 4982 such as that shown in fig. 105 and 106 applied with a nozzle applicator.

The adjunct material can be applied to a staple cartridge used with a surgical stapler. Fig. 108 illustrates an applicator nozzle 4984 coupled to a staple cartridge 4983 to apply an adjunct 4985 to staples 4986 loaded in the cartridge. Fig. 109 also shows the applicator nozzle 4988 fitted to the staple cartridge 4983. In fig. 109, the adjunct material 4987 flowing over the staples 4986 is made up of two components or components that are mixed just prior to application of the adjunct material to the cartridge. FIG. 110 provides a view of the adjunct material 4989 applied over staples 4986 loaded in a stapler cartridge 4983.

Fig. 111 shows surgical staples 4992 improperly positioned within tissue 4991. Such a configuration 4990 may occur when there is no adjunct material present to distribute forces from the staples on the tissue and prevent the staples from cutting through the tissue or unduly compressing the tissue. Fig. 113 illustrates how the presence of the adjunct material 4998 on the anvil side of the staples 4997 can allow for proper placement of the staples 4997 in the tissue 4996.

Fig. 112 illustrates a rod of gel assistance material 4994 applied to an anvil 4995 or staple cartridge of a surgical stapler 4993. This is an alternative embodiment of the method for applying an auxiliary material and the applicator of an auxiliary material. In this manner, the surgical stapler can be reloaded and quickly prepared, such as when a surgeon desires to use a single surgical stapler multiple times in a single procedure.

114A-114C illustrate a surgical staple 41010 used with an auxiliary element 41012 for use with a surgical stapler 41000 to transect tissue 41002. In the surgical stapler 41000, the anvil 41004 can be loaded with adjunct segments 41012 that interact with staples 41010 loaded in the staple cartridge 41006. The adjunct 41012 in the anvil 41004 can hold the staples 41010 not applied to the tissue 41002 as shown in fig. 114C.

Accessory for anastomosis

Anastomosis is a process that requires the formation of a circular incision through the staple line at each end of the tissue to be joined. Cutting through the staple line may cause tearing or partial cutting of the staple. Tissue crimping at the staple line corners may have leaks or allow debris collection, however, if the crimping cannot be completely eliminated, it is desirable to seal them to minimize leaks. Described above is a adjunct assembly for use with a particular staple cartridge configuration that includes a crimped seal and that passes a minimal amount of staples through the area that is ultimately cut by a circular cutting tool.

Fig. 115 illustrates an embodiment of a discontinuous aid 41020 for forming an anastomosis. Discontinuous assist 41020 comprises a ring 41022 or washer located at the center of the assist. Suture filaments 41026 are attached to each side, spaced 180 ° apart. The suture filaments are connected to the sealing material 41024. Each portion of the sealing material 41024 is configured to be capable of sealing a crimped portion of the staple line. The sealing material 41024 is configured to span multiple staples and once inserted into tissue, the staples can have the sealing material 41024 adjacent the crowns of the staples or adjacent the anvil seat side. In some embodiments, the sealing material 41024 is configured to be adjacent to the crown of a staple deployed in tissue. Such sealing material may be complementary to the sealing material (such as an adjunct segment) on the anvil side of the staple.

Fig. 116 and 117 illustrate a surgical staple cartridge 41028 and staple patterns used with the adjunct of fig. 115. The staple pattern on the cartridge 41028 is shown as an area having two or more rows 41030 and an area having a single row 41031. The single row of staples 41031 is intended or configured to correspond to the portion of tissue that will be cut through when a circular incision is made. The suture filament 41026 of the discontinuous aid 41020 is delivered parallel to this single staple row 41030. The area of the two or more staple rows 41030 corresponds to where the crimp in the tissue will be. The sealing material 41024 of the discontinuity aid 41020 is configured to be usable with the two or more rows 41030, as shown in fig. 116.

In the staple cartridge 41028 illustrated in fig. 116 and the staple pattern described in fig. 117, a single row 41031 can be seen to be centered with respect to multiple rows 41030 in the hem region. The suture filaments 41026 of the discontinuous aid 41020 will not only be substantially parallel to the single row 41031, but the suture filaments 41026 will nearly overlap the single row 41031 once the aid 41020 is deployed into tissue with a surgical staple. More than one discontinuous aid 41020 can be deployed simultaneously and is shown in fig. 116, in which case the discontinuous aids 41020 can be substantially similar.

Fig. 118 is an illustration of an alternative embodiment of a discontinuous adjunct for forming an anastomosis. Two

discontinuous aids

41040,41050 are shown as mirror images of each other. The discontinuity aids 41040,41050 each have a

washer

41046,41056 attached to the

suture filament

41044,41054. The

suture filament

41044,41054 is attached to a sealing

material

41042,41052 configured to span a plurality of surgical staples in a hemmed area of stapled tissue.

Fig. 119-123 illustrate additional views of the surgical stapler cartridge 41060 used with the adjunct of fig. 118, and the

discontinuous adjunct

41040,41050 of fig. 118. Stapler cartridge 41060 is symmetrical about a centerline in which an incision can be made through the stapled tissue. The cartridge 41060 has areas for a single staple row 41064 and for multiple staple rows 41062 on each half of the cartridge. Multiple rows of staples 41062 are located at the ends of the staple lines and where the crimped portions of the tissue will be located. The single staple row 41064 is off-center relative to the multiple staple rows 41062 such that the single staple row 41064 is positioned toward the edge of the cartridge 41060. When the

discontinuous aid

41040,41050 is overlaid onto the cartridge, the sealing

material

41042,41052 corresponds to the area on the cartridge 41060 having multiple rows 41062 of staples, the

gaskets

41046,41056 are each centered on a single row 41064, each on half of the cartridge 41060. The

suture filament

41046,41056 is substantially parallel to the individual staple rows 41064, but does not cover them. FIG. 121 illustrates the relative positioning of

discontinuity aid

41040,41050 and staples, showing unsealed staples 41066 of a single row of staples. These unsealed staples 41066 may be cut through or removed when forming the anastomosis. Fig. 122 shows the view of fig. 121 superimposed on the view of fig. 120. FIG. 123 includes a depression in the staple cartridge 41060 below the

washer

41046,41056.

FIG. 124 shows an embodiment of an adjunct washer 41066 before and during actuation of a surgical stapler. The gasket 41066 can be a gasket similar to any of the

gaskets

41022,41046,41056 described above. The gasket 41066 is shown in a recess in the stapler cartridge 41064. Suture filament 41068 is attached to washer 41066. The washer 41066 is substantially circular in cross-section prior to staple deployment when the adjunct is placed in a surgical stapler. During staple deployment, the gasket 41066 is compressed from the surgical stapler under pressure 41070. The gasket 41066 then has a substantially elliptical cross-section. Under pressure, gasket 41066 becomes flush or nearly flush with the upper portion of the staple cartridge while filling or nearly filling the recess.

FIG. 125 illustrates an embodiment of a surgical staple cartridge for forming an anastomosis, which side view allows for a comparison of the tips of standard staple cartridges 41072 and L AR 41074 those skilled in the art will appreciate that this can be used in the L AR procedure to reduce the length of the end effector distal to the articulation node in the stapler.

FIG. 126 shows a body cavity transected by a surgical stapler having an adjunct, such as the adjunct shown in FIG. 118. Tissue 41076 is shown with

discontinuous aids

41040,41050 in place.

Washer

41046,41056 is aligned and alongside each

washer

41046,41056 and the

suture filaments

41044,41054 connected to each washer are individual rows of staples 41066 that are not sealed by the secondary material. The sealing

material

41042,41052 prevents leakage in the crimped portion of tissue having multiple rows of staples.

Figures 127A-127C illustrate cross-sectional views of an aid 41050 and circular stapler trocar 41078 using an aid such as that shown in figure 118. Fig. 127A shows a discontinuous aid in tissue 41076 with a washer 41056 positioned above the staple line including an unsealed single row 41066 of staples. Fig. 127B shows the trocar 41076 in proximity to the staple line 41066 and the grommet 41056 as it moves through the lumen in the tissue 41076. Fig. 127C illustrates the engagement of the trocar 41078 with the gasket 41066. Fig. 128 illustrates the relative positioning of all components of the adjunct 41505 when the trocar 41078 is engaged with the gasket 41056.

Fig. 128-136 illustrate a circular stapler trocar 41078 passing through the gasket portion of the discontinuous aid 41050. Fig. 129 shows a discontinuous aid 41050 having a gasket 41056, suture filament 41054, and sealing material 41052 at the hem of tissue 41076. The circular stapling and cutting tool 41080 is inside the tissue 41076. The trocar 41078 is centered on the staple and cutting tool 41080. The trocar 41078 extends through the washer 41056 toward a shaft 41084 connected to the anvil 41082 in another portion of the tissue 41076 that has been cut and sealed along the staple line 41088. The anvil 41082 is shown above the buttonhole adjacent the shaft 41084.

Fig. 130 shows an embodiment similar to the embodiment shown in fig. 129. In fig. 130, discontinuity aids 41040,41050 are shown each having a

washer

41046,41056, a

suture filament

41044,41054, and a sealing

material

41042,41052 on a crimp of tissue 41076. A single row of staples 41066 is looped around each of the

washers

41046,41056 adjacent the suture filament. The circular staple and cutting tool are inside the tissue 41076, and the trocar 41078 extends through one washer 41056 toward a mating shaft that extends through the other washer 41046.

Figure 131-133 illustrate cross-sectional views of portions of tissue 41076 moved toward one another such that the tissue can be stapled (figure 135) and cut (figure 136) to form an anastomosis. Fig. 131 is the cross-sectional view of fig. 129, but with the shaft 41084 attached to the anvil 41082 fitted over the trocar 41078 and in contact with the washer 41056. Fig. 132 is a close-up view of the shaft 41084 attached to the central portion of the anvil and adjunct 41050, particularly the washer 41056 and suture filament 41054. As the shaft 41084 moves downward to move the two portions of tissue 41076 together, the shaft 41084 moves the suture filament 41054 downward to move the sealing material 41052 on the bead closer together, as shown in fig. 133. Figure 134 illustrates the movement of the sealing material 41052 on the crimp toward the trocar 41078 when the shaft moves the gasket 41056 downward. Fig. 135 shows the tissue portions attached by the staples 41100. An auxiliary 41050 having a washer 41056 pushed axially downward and a sealing material 41052 at the crimp portion is shown in the center of the stitching and cutting tool 41080. Fig. 136 shows tissue 41076 after making a circular incision. The tissue is joined by three rows of staples 41100 in a circular configuration in which previously stapled tissue including the discontinuous aid 41050 is removed. The

adjuncts

41033,41040,41040 described above may be used interchangeably or in combination in the methods for forming the anastomosis as shown in figures 126 and 136.

Reprocessing

The device disclosed herein may be designed to be discarded after a single use, or it may be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. The repair may include any combination of the following steps: disassembly of the device, followed by cleaning or replacement of particular parts and subsequent reassembly. In particular, the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. After cleaning and/or replacement of particular components, the device may 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 the prosthetic device may be disassembled, cleaned/replaced, and reassembled using a variety of techniques. The use of such techniques, as well as the resulting prosthetic devices, are within the scope of the present application.

In some embodiments, the devices described herein can be processed prior to surgery. First, new or used instruments, which may contain auxiliary materials, are obtained and, if necessary, cleaned. The instrument may then be sterilized. In some embodiments, the device may be dried, for example in an oven, along with a desiccant item that may have a greater affinity for moisture than the secondary material. In one sterilization technique, the instrument is placed in a closed and sealed container such as a plastic or TYVEK bag or foil bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. In another sterilization technique, the instrument is placed in a first container (such as a plastic or TYVEK bag) having a vapor permeable backing. The first container is then enclosed in a second container (e.g., a foil pouch) that may be left open. The first and second containers, along with the instruments, may be subjected to ethylene oxide sterilization. The second container may then be sealed to prevent moisture exposure. A desiccant item may be included in at least one of the first container and the second container prior to sealing to further prevent alteration of one or more device components. In both techniques, sterile material may then be stored in the one or more sterile containers to maintain the sterility of the material until the one or more containers are opened in the medical facility.

Those skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All patent publications and references cited herein are incorporated by reference in their entirety.

Claims

1. A staple cartridge assembly for use with a surgical stapler, comprising:

a cartridge body configured to be disposed within jaws of the surgical stapler, the cartridge body having a plurality of staple cavities, each staple cavity having an undeployed surgical staple disposed therein, each surgical staple having a pair of legs, each leg of the surgical staple having an adjunct disposed about each leg prior to the cartridge body being disposed within the jaws and being movable independently of an adjunct disposed about the other leg of the surgical staple, and each adjunct forming a fluid seal about a leg of the surgical staple disposed therewith upon deployment of the surgical staple from the cartridge body.

2. The assembly of claim 1, wherein the auxiliary element is in the form of a plug.

3. The assembly of claim 2, wherein, for each undeployed surgical staple, a first auxiliary plug is disposed about a first leg of the surgical staple and a second auxiliary plug is disposed about a second leg of the surgical staple such that the first and second auxiliary plugs are adapted to form a seal about the first and second legs of the surgical staple, thereby sealing a puncture hole formed in tissue by the surgical staple.

4. The assembly of claim 1, wherein the adjunct is in the form of a pledget configured to seal around both the first and second legs of a surgical staple.

5. The assembly of claim 1, wherein the adjunct is in the form of a covering disposed around a leg of an undeployed surgical staple.

6. The assembly of claim 1, wherein the adjunct is formed of a swellable material that expands upon contact with bodily fluids.

7. The assembly of claim 6, wherein the swellable material is a hydrogel.

8. The assembly of claim 1, wherein the auxiliary element is formed of foam.

9. The assembly of claim 1, wherein the adjunct is positioned adjacent crowns of the surgical staples prior to deployment from the cartridge body.

10. The assembly of claim 1, wherein the adjunct is positioned at a distal end of at least one leg of an undeployed surgical staple opposite a crown of the surgical staple prior to deployment from the cartridge body.

11. The assembly of claim 1, wherein the adjunct is configured to slide over at least one leg of the surgical staple.