US20150351753A1

Movatterモバイル変換

Info

Publication number: US20150351753A1
Application number: US14/300,793
Authority: US
Inventors: Frederick E. Shelton, IV; Jason L. Harris; Jeffrey S. Swayze; Gregory Bakos; Adam R. Dunki-Jacobs; Bret W. Smith; Simon Cohn; John Matonick
Original assignee: Ethicon Endo Surgery LLC
Current assignee: Cilag GmbH International
Priority date: 2014-06-10
Filing date: 2014-06-10
Publication date: 2015-12-10
Also published as: WO2015191219A1; US20150351761A1; US10610226B2; EP2954848A1; EP2954850A1; WO2015191279A1; EP2954848B1

Abstract

Adjunct material and methods of using adjunct material to reinforce a staple line are provided herein. In general, adjunct material can be used to maintain a seal in tissue and prevent stapled tissue from tearing. This adjunct material can be coupled to a jaw of a surgical stapler, and can be deployed into tissue along with the staples. In some embodiments, the adjunct material can be sized and shaped so that a portion of the material extends laterally outside of the staple line and distributes strain to tissue outside of the staple line. In certain aspects, sealant can be applied to the staple line and to the adjunct material in various ways to further seal the tissue and/or prevent leaks from forming in the tissue.

Description

FIELD

The subject matter disclosed herein relates to methods and devices for reinforcing a staple line.

BACKGROUND

Surgical staplers are used in surgical procedures to seal, divide, and/or transect tissues in the body by closing openings in tissue, blood vessels, ducts, shunts, or other objects or body parts involved in the particular procedure. The openings can be naturally occurring, such as passageways in blood vessels, airways or an internal lumen or organ like the stomach, or they can be formed by the surgeon during a surgical procedure, such as by puncturing tissue or blood vessels to form a bypass or an anastomosis, or by cutting tissue during a stapling procedure.

Most staplers have a handle with an elongate flexible or rigid shaft having a pair of opposed jaws formed on an end thereof for holding and forming staples therebetween. At least one of the opposed jaws is movable relative to the other jaw. In the case of laparoscopic surgery, often one jaw is fixed and the other is movable. In some devices (for example an open linear stapler), the opposed jaws can be separated by the operator and reassembled providing the relative motion needed for tissue placement. The staples are typically contained in a staple cartridge, which can house multiple rows of staples and is often disposed in one of the two jaws for ejection of the staples to the surgical site. In use, the jaws are positioned so that the object to be stapled is disposed between the jaws, and staples are ejected and formed when the jaws are closed and the device is actuated. Some staplers include a knife configured to travel between rows of staples in the staple cartridge to longitudinally cut the stapled tissue between the stapled rows. Placement of the device, manipulation of components or systems of the device, and other actuations of the device such as articulation, firing, etc. can be accomplished in a variety of ways, such as electromechanically, mechanically, or hydraulically.

While surgical staplers have improved over the years, a number of problems can potentially arise. Although rare, as illustrated inFIG. 1, one problem is that leaks can occur due to staples S forming tears H when penetrating a tissue T or other object in which the staples S are disposed. Blood, air, gastrointestinal fluids, and other fluids can seep through the tears H formed by the staples S, even after the staples S are fully formed. The tissue T being treated can also become inflamed due to the manipulations and deformations that can occur during stapling. Still further, staples, as well as other objects and materials implanted during stapling procedures, generally lack the same characteristics as tissue in which they are implanted. For example, staples and other objects and materials can lack the natural flexibility of the tissue in which they are implanted. A person skilled in the art will recognize that it is often desirable for tissue to maintain as much of its natural characteristics as possible after staples are disposed therein.

Accordingly, there remains a need for methods and devices for reinforcing a staple line.

SUMMARY

A staple cartridge for use with a surgical stapler is provided and can include a cartridge body and an adjunct material. The cartridge body can have a plurality of staple cavities configured to seat staples therein. The adjunct material can be mated to the cartridge body and configured to be detached therefrom as the staples are deployed from the cartridge body and into tissue. The adjunct material can include a solid central portion sized and shaped to substantially correspond to the cartridge body, and a wing portion extending along at least two sides of the solid central portion such that the wing portion extends beyond a lateral boundary of the cartridge body in a direction traverse to a longitudinal axis of the cartridge body.

The solid central portion of the adjunct material can vary in any number of ways. For example, the solid central portion of the adjunct material can be substantially rectangular shaped. In certain aspects, the solid central portion can include first and second opposed edges. In other aspects, the wing portion can extend along the first and second opposed edges of the adjunct material. In use, the solid central portion can be configured to reinforce a seal around staples when the adjunct material and the staples are coupled to tissue.

The wing portion can have various features. For example, the wing portion can include rounded corners. For another example, the wing portion can have a mesh structure. In certain aspects, the wing portion can have plurality of openings formed therein. In use, the wing portion can be configured to distribute or otherwise alter a strain or deformation present in tissue beyond the staple line when the adjunct material is disposed on tissue.

The solid and wing portions can be formed from various materials. In certain aspects, the solid and wing portions can be formed from a single polymer. In certain aspects, the solid and wing portions can be formed from more than one material or type of material. In certain aspects, the solid and wing portions can be formed from different materials. In other aspects, the wing portion can be more flexible than the solid central portion of the adjunct material.

An end effector for a surgical instrument is provided and can include first and second jaws, the first jaw having a cartridge body removably attached hereto and the cartridge body having a plurality of staple cavities configured to seat staples therein. The second jaw can include an anvil with a plurality of staples forming openings formed therein, at least one of the first and second jaws being movable relative to the other jaw. The end effector can include a buttress having a width greater than a width of at least one of the cartridge body and the anvil, the buttress having a compressible, central region configured to seal around a staple and a strain relief region adjacent to the compressible region. The strain relief region can have a plurality of openings formed therein and the strain relief region can extend from at least two sides of the central region. In use, the buttress can be releasably retained on at least one of the cartridge body and the anvil and can be configured to be released therefrom upon deployment of staples from the cartridge body and into the compressible region of the buttress.

The end effector can vary in a number of ways. In certain aspects, the plurality of openings include slits. When the buttress and the staples are deployed into tissue, the plurality of slits can extend parallel to longitudinal axes of the staples. In other aspects, the plurality of openings are spaced apart such that the strain relief region is more flexible along a lateral portion thereof than a portion of the strain relief region adjacent to the compressible region. In other aspects, the plurality of openings are shaped and spaced apart such that the strain relief region is more flexible along a longitudinal portion thereof than a portion of the strain relief region adjacent to the compressible region.

A method for implanting a tissue reinforcement material onto tissue is provided and includes engaging tissue between a cartridge assembly and an anvil of a surgical stapler at a surgical site, at least one of the cartridge assembly and the anvil having a tissue reinforcement material releasably retained thereon. The tissue reinforcement material can include a compressible, central region configured to seal around a staple and a flexible supportive region adjacent to the central region and defining an edge of the tissue reinforcement material. Actuating the surgical stapler can eject staples from the cartridge assembly so as to form a staple line through the central region and into the tissue to hold the tissue reinforcement material at the surgical site.

The method can vary in any number of ways. For example, actuating the surgical stapler can eject the staples through the central region and does not eject the staples through the flexible supportive region of the tissue reinforcement material. In certain aspects, the cartridge assembly and the anvil can be inserted into the surgical site with the flexible supportive region folded around at least one of the cartridge assembly and the anvil. Actuating the surgical stapler can advance a cutting member through the tissue reinforcement material and releases the tissue reinforcement material from the surgical stapler. In certain aspects, actuating the surgical stapler advances the cutting member through the central region of the tissue reinforcement material.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

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

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

FIG. 3 is a perspective view of a prior art surgical instrument which can be used with one or more adjunct materials;

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

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

FIG. 6 is a perspective view of another prior art surgical instrument which can be used with one or more adjunct materials;

FIG. 7 is a perspective view of another prior art surgical instrument which can be used with one or more adjunct materials;

FIG. 8 is a perspective view of the end effector ofFIG. 4;

FIG. 9 is a side view of a prior art end effector having an implantable staple cartridge therein;

FIG. 10 is a side view of a prior art staple;

FIG. 11 is a cross-sectional view of the end effector ofFIG. 9;

FIG. 12 is a top view of a prior art staple cartridge for use with the instrument ofFIG. 7;

FIG. 13 is a diagrammatic representation of lines of staples installed using a prior art surgical stapling instrument;

FIG. 14 is a top view of a prior art staple cartridge having a staple pattern;

FIG. 15 is a side view of an end effector with a staple cartridge loaded with an adjunct material;

FIG. 16 is a side, cross-sectional view of the end effector ofFIG. 4 having an adjunct material thereon;

FIG. 17A is a perspective view of adjunct material having a central portion and a wing portion, the adjunct material being coupled to a cartridge assembly;

FIG. 17B is a perspective view of an adjunct material stapled onto tissue;

FIG. 18 is a perspective view of another exemplary embodiment of adjunct material stapled to tissue;

FIG. 19A is a perspective view of an adjunct material having edge protrusions configured to distribute a strain to tissue beyond a staple line;

FIG. 19B is a perspective view of another adjunct material having edge protrusions, the adjunct material being stapled to tissue;

FIG. 20 is a perspective view of an adjunct material including an outer region with a plurality of cuts formed therein;

FIGS. 21A-21C are side views of adjunct material having modified outer regions;

FIG. 21D is a side, cross-sectional view of adjunct material stapled to a body lumen;

FIG. 22A is a perspective view of adjunct material having first and second layers and woven, atraumatic edges;

FIG. 22B is a side view of the adjunct material ofFIG. 22A showing the first and second layers;

FIG. 22C is a side view of the adjunct material ofFIG. 22A absorbing fluid in between the first and second layers;

FIG. 23A is a perspective view of adjunct material having a variable thickness in a lateral direction;

FIG. 23B is an end view of an anvil and cartridge assembly and two variable thickness adjuncts, a first adjunct material associated with the anvil and a second adjunct material associated with the cartridge assembly;

FIG. 23C is an end view of the anvil and cartridge assembly ofFIG. 23B having the first and second adjunct materials coupled thereto;

FIG. 23D is a side view of the first and second adjunct material stapled to tissue;

FIG. 24A is a side view of an adjunct material having surface features formed thereon for penetrating and gripping into tissue;

FIG. 24B is a side view of another adjunct material having surface features for penetrating and gripping into tissue;

FIG. 24C is an end view of four rows of adjunct material, each row of adjunct material having a surface feature locked in a tissue;

FIG. 24D is a side view of an adjunct material having surface features penetrated into tissue;

FIG. 25A is a side view of another exemplary adjunct material having a plurality of pointed surface features for penetrating into tissue;

FIG. 25B is a side view of the adjunct material ofFIG. 24A having the pointed surface features piercing into tissue;

FIG. 26A is a perspective view of a cartridge assembly having an adjunct material for detachable coupling to a distal end of the cartridge assembly;

FIG. 26B is a side view of the cartridge assembly and an anvil of a surgical stapler grasping tissue with the adjunct material ofFIG. 26A extending beyond a distal end of the cartridge assembly;

FIG. 26C is a side view of the cartridge assembly and the anvil ofFIG. 26B deploying staples through the adjunct material and the tissue;

FIG. 27A is a perspective view of adjunct material having protrusions configured to mate with corresponding depressions formed in a cartridge assembly;

FIG. 27B is a perspective view of adjunct material having a single protrusion configured to mate with a corresponding depression formed in a cartridge assembly;

FIG. 28A is an end view of an adjunct material extending around a cartridge assembly and having first and second lateral edges coupled to the cartridge assembly;

FIG. 28B is an end view of the adjunct material and the cartridge assembly ofFIGS. 27A and a cutting member being advanced through the cartridge assembly to release the adjunct material from the cartridge assembly;

FIG. 29A is a perspective view of a cartridge assembly including suture coupling an adjunct material to the cartridge assembly;

FIG. 29B is a perspective view of the cartridge assembly and adjunct material ofFIG. 29A, the suture detached from the cartridge assembly to release the adjunct material;

FIG. 30A is a perspective view of a shaft of a surgical stapler including an adjunct material coupled thereto;

FIG. 30B is a side view of the shaft ofFIG. 30A showing attachment points for attaching the adjunct material to the shaft;

FIG. 30C is a perspective view of a driver insertable within the shaft and having a plurality of lateral extension portions;

FIG. 30D is a perspective view of adjunct material for attaching to the shaft;

FIG. 30E is a partial top view of the shaft ofFIG. 30A with a cutting member of the stapler in a first, retracted position;

FIG. 30F is a partial top view of the shaft ofFIG. 30A with the cutting member in a second, advanced position that releases the adjunct material from the shaft;

FIG. 31A is an end view of a cartridge assembly, an adjunct material, and an insertion tool for attaching the adjunct material to the cartridge assembly;

FIG. 31B is an end view of the insertion tool pressing the adjunct material onto the cartridge assembly ofFIG. 31A;

FIG. 31C is an end view of the cartridge assembly ofFIG. 31A having the adjunct material attached thereto and after the insertion tool has been removed from the cartridge assembly;

FIG. 32A is an exemplary kit including a retaining tool and a surgical stapler, the retaining tool being configured for wrapping the adjunct material around a cartridge assembly/anvil;

FIG. 32B is a side view of the retaining tool ofFIG. 32A being advanced proximally along a longitudinal axis of the anvil and the cartridge assembly;

FIG. 32C is a perspective view of the retaining tool and stapler ofFIG. 32A, the retaining tool being in a proximal most position;

FIG. 33A is a perspective view of an end effector of a stapler having an adjunct material coupled thereto and positioned above a trocar;

FIG. 33B is a perspective view of the end effector ofFIG. 33A having the adjunct material wrapped around the end effector as the end effector is inserted through the trocar;

FIG. 34A is an end view of a cartridge assembly and an anvil of a surgical stapler having a multi-layer adjunct material coupled thereto;

FIG. 34B is a side view of three adjuncts stapled onto tissue and having overlapping portions therebetween;

FIG. 34C is a perspective view of a first adjunct material and a second adjunct material stapled onto tissue and having first and second overlapping portions;

FIG. 35A is a perspective view of first and second adjunct materials stapled onto tissue and having a sealant delivered onto an outer surface of the first adjunct;

FIG. 35B is a side view of the first and second adjunct materials ofFIG. 35A stapled to tissue;

FIG. 35C is a side view of the first and second adjunct materials ofFIG. 35A having sealant delivered to a space below an outer surface of the adjunct;

FIG. 35D is a side view of the first and second adjunct materials ofFIG. 35A in an expanded position;

FIG. 36A is a perspective view a system for nebulizing a sealant which includes a container and an applicator tool extending through a trocar and into a patient;

FIG. 36B is perspective view of the applicator tool ofFIG. 36A delivering sealant to a staple line in tissue;

FIG. 36C is a perspective view of the nebulized sealant ofFIG. 36A hardened onto the staple line;

FIG. 37A is a perspective view of another exemplary system for nebulizing a sealant and delivering a nebulized sealant to a patient directly through a trocar and into a patient; and

FIG. 37B is a perspective view of the trocar ofFIG. 37A delivering nebulized sealant onto tissue at and beyond the staple line.

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. Further, in the present disclosure, like-numbered components of the various embodiments generally have similar features when those components are of a similar nature and/or serve a similar purpose.

Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” or “an embodiment,” or the like, 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, in places throughout the 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, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the 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 reference to a clinician manipulating the handle portion of the surgical instrument. The term “proximal” referring to the portion closest to the clinician and the term “distal” referring to the portion located away from the clinician. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.

It can be desirable to use one or more biologic materials and/or synthetic materials, collectively referred to herein as “adjunct materials,” in conjunction with surgical instruments to help improve surgical procedures. These biologic materials may be derived from human and/or animal sources. A person skilled in the art may refer to these types of materials as buttress materials as well as adjunct materials.

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

End effectors of the surgical instruments as described herein can be configured to deliver one or more synthetic materials and/or biologic materials, collectively referred to herein as “adjunct materials,” to a surgical site to help improve surgical procedures. These biologic materials may be derived from human and/or animal sources. While a variety of different end effectors can benefit from the use of adjunct materials, in some exemplary embodiments the end effector can be a surgical stapler. When used in conjunction with a surgical stapler, the adjunct material(s) can be disposed between and/or on jaws of the stapler, incorporated into a staple cartridge disposed in the jaws, or otherwise placed in proximity to the staples. When staples are deployed, the adjunct material(s) can remain at the treatment site with the staples, in turn providing a number of benefits. In some instances, the adjunct material(s) can be used to help seal holes formed by staples as they are implanted into tissue, blood vessels, and various other objects or body parts, and/or can be used to provide tissue reinforcement at the treatment site. Tissue reinforcement may be needed to keep the staples from tearing through the tissue if the tissue is diseased, is healing from another treatment such as irradiation, medications such as chemotherapy, or other tissue property altering situation. In some instances, the adjunct material(s) may minimize tissue movement in and around the staple puncture sites that can occur from tissue deformation that occurs after stapling (e.g., lung inflation, gastrointestinal tract distension, etc.). It will be recognized by one skilled in the art that a staple puncture site may serve as a stress concentration and that the size of the hole created by the staple will grow when the tissue around it is placed under tension. Restricting the tissues movement around these puncture sites can minimize the size the holes may grow to under tension. In some instances, the adjunct material(s) can be configured to wick or absorb beneficial fluids, e.g., sealants, blood, glues, that further promote healing, and in some instances, the adjunct material(s) can be configured to degrade to form a gel, e.g., a sealant, that further promotes healing. In some instances, the adjunct may carry materials that when placed into a wet environment (e.g., blood, water, saline, or other bodily fluids) form a sealant to create a seal (e.g., human or animal derived fibrinogen and thrombin can be lyophilized into a powder form that when mixed with water creates a sealant). Still further, the material(s) can help reduce inflammation, promote cell growth, and otherwise improve healing.

FIG. 2 illustrates one embodiment of an adjunct material that includes a porous buttress30 that can be fixed to a tissue T to be treated by a surgical stapler and that remains at the treatment site withstaples70. The buttress30 can be made from one or more absorbent materials and can be stamped, pressed, cut, molded, woven, melted, blown, comprised from composite structures and/or methods or otherwise shaped to facilitate absorption, reinforcement, delivery and/or retention of beneficial fluids such as sealants, glues, blood, etc. The absorption and/or retention of beneficial fluids, for example afibrin sealant40, at the treatment site can further help to prevent leaks and to reinforce thebuttress30.

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 asurgical stapler10 suitable for use with one or more adjunct materials. Theinstrument10 generally includes ahandle assembly12, ashaft14 extending distally from adistal end12dof thehandle assembly12, and anend effector50 at adistal end14dof theshaft14. Because the illustrated embodiment is a surgical stapler, theend effector50 has

jaws

52,54, although other types of end effectors can be used with theshaft14, handleassembly12, and components associated with the same. Thesurgical stapler10 includes opposed lower and

upper jaws

52,54 with thelower jaw52 including a staple channel56 (FIG. 4) configured to support astaple cartridge60, and theupper jaw54 having aninner surface58 that faces thelower jaw52 and that is configured to operate as an anvil to help deploystaples70 of thestaple cartridge60. The

jaws

52,54 are configured to move relative to one another to clamp tissue or other objects disposed therebetween, and components of a firing system can be configured to pass through at least a portion of theend effector50 to eject the staples into the clamped tissue. In various embodiments aknife blade81 can be associated with the firing system to cut tissue during the stapling procedure. At least one of the opposed lower and

upper jaws

52,54 will be moveable relative to the other lower and

upper jaws

52,54. At least one of the opposed lower and

upper jaws

52,54 may be fixed or otherwise immovable. In some embodiments, both of the opposed lower and

upper jaws

52,54 will be movable.

Operation of theend effector50 can begin with input from a clinician at thehandle assembly12. Thehandle assembly12 can have many different configurations designed to manipulate and operate theend effector50 associated therewith. In the illustrated embodiment, thehandle assembly12 has a pistol-grip type housing18 with a variety of mechanical and/or electrical components disposed therein to operate various features of the instrument. For example, thehandle assembly12 can include arotation knob26 mounted adjacent adistal end12dthereof which can facilitate rotation of theshaft14 and/or theend effector50 with respect to thehandle assembly12 about a longitudinal axis L of theshaft14. Thehandle assembly12 can further include clamping components as part of a clamping system actuated by a clampingtrigger22 and firing components as part of the firing system that are actuated by a firingtrigger24. The clamping and firing triggers22,24 can be biased to an open position with respect to astationary handle20, for instance by a torsion spring. Movement of the clampingtrigger22 toward thestationary handle20 can actuate the clamping system, described below, which can cause the

jaws

52,54 to collapse towards each other and to thereby clamp tissue therebetween. Movement of the firingtrigger24 can actuate the firing system, described below, which can cause the ejection of staples from a staple cartridge disposed therein and/or the advancement theknife blade81 to sever tissue captured between the

jaws

52,54. A person skilled in the art will recognize that various configurations of components for a firing system, mechanical, hydraulic, pneumatic, electromechanical, robotic, or otherwise, can be used to eject staples and/or cut tissue, and thus a detailed explanation of the same is unnecessary.

As shown in more detail inFIG. 4, theend effector50 of the illustrated embodiment is a surgical stapling tool having alower jaw52 that serves as a cartridge assembly or carrier and an opposedupper jaw54 that serves as an anvil. Thestaple cartridge60, having a plurality ofstaples70 therein, is supported in a staple tray57, which in turn is supported within the cartridge channel of thelower jaw52. Theupper jaw54 has a plurality of staple forming pockets66 (FIG. 11), each of which is positioned above a corresponding staple from the plurality ofstaples70 contained within thestaple cartridge60. Theupper jaw54 can be connected to thelower jaw52 in a variety of ways, although in the illustrated embodiment theupper jaw54 has a proximal pivotingend54pthat is pivotally received within a proximal end56pof thestaple channel56, just distal to its engagement to theshaft14. When theupper jaw54 is pivoted downwardly, theupper jaw54 moves theanvil surface58 and the staple forming pockets66 formed thereon move toward the opposingstaple cartridge60.

Various clamping components can be used to effect opening and closing of the

jaws

52,54 to selectively clamp tissue therebetween. In the illustrated embodiment, the pivotingend54pof theupper jaw54 includes aclosure feature54cdistal to its pivotal attachment with thestaple channel56. Thus, aclosure tube82, whose distal end includes ahorseshoe aperture82athat engages theclosure feature54c,selectively imparts an opening motion to theupper jaw54 during proximal longitudinal motion and a closing motion to theupper jaw54 during distal longitudinal motion of theclosure tube82 in response to the clampingtrigger22. It will be appreciated by a person skilled in the art that opening and closure of theend effector50 may be effected by relative motion of thelower jaw52 with respect to theupper jaw54, relative motion of theupper jaw54 with respect to thelower jaw52, or by motion of both

jaws

52,54 with respect to one another.

The firing components of the illustrated embodiment can include a firingbar84, as shown inFIG. 5, having an E-beam86 on a distal end thereof. The firingbar84 is encompassed within theshaft14, for example in a longitudinalfiring bar slot14sof theshaft14, and guided by a firing motion from thehandle12. Actuation of the firingtrigger24 can affect distal motion of the E-beam86 through at least a portion of theend effector50 to thereby cause the firing ofstaples70 contained within thestaple cartridge60. In the illustrated embodiment, guides85 projecting from a distal end of the E-Beam86 can engage awedge sled90, which in turn can pushstaple drivers92 upwardly throughstaple cavities68 formed in thestaple cartridge60. Upward movement of thestaple drivers92 applies an upward force on each of the plurality ofstaples70 within thecartridge60 to thereby push thestaples70 upwardly against theanvil surface58 of theupper jaw54 and to create formedstaples70′.

In addition to causing the firing of staples, the E-beam86 can be configured to facilitate closure of the

jaws

52,54, spacing of theupper jaw54 from thestaple cartridge60, and/or severing of tissue captured between the

jaws

52,54. In particular, a pair oftop pins87 and a pair of bottom pins89 can engage one or both of the upper and

lower jaws

52,54 to compress the

jaws

52,54 toward one another as the firingbar84 advances through theend effector50. Simultaneously, aknife81 extending between the top and bottom pins87,89 can be configured to sever tissue captured between the

jaws

52,54.

In use, thesurgical stapler10 can be disposed in a cannula or port and disposed at a surgical site. A tissue to be cut and stapled can be placed between the

jaws

52,54 of thesurgical stapler10. Features of thestapler10 can be maneuvered as desired by the clinician to achieve a desired location of the

jaws

52,54 at the surgical site and the tissue with respect to the

jaws

52,54. After appropriate positioning has been achieved, the clampingtrigger22 can be pulled toward thestationary handle20 to actuate the clamping system. Thetrigger22 can cause components of the clamping system to operate such that theclosure tube82 advances distally through at least a portion of theshaft14 to cause at least one of the

jaws

52,54 to collapse towards the other to clamp the tissue disposed therebetween. Thereafter, thetrigger24 can be pulled toward thestationary handle20 to cause components of the firing system to operate such that the firingbar84 and/or theE-beam86 are advanced distally through at least a portion of theend effector50 to effect the firing ofstaples70 and optionally to sever the tissue captured between the

jaws

52,54.

Another embodiment of asurgical instrument100 is illustrated inFIG. 6. Likesurgical instrument10,surgical instrument100 includes ahandle assembly112 with a shaft114 extending distally therefrom and having anend effector150 on a distal end thereof for treating tissue. Upper and

lower jaws

154,152 of theend effector150 can be configured to capture tissue therebetween, staple the tissue by firing of staples from acartridge160 disposed in thelower jaw154, and/or to create an incision in the tissue. In this embodiment, an attachment portion116 on a proximal end of the shaft114 can be configured to allow for removable attachment of the shaft114 and theend effector150 to thehandle assembly112. In particular, mating features125 of the attachment portion116 can mate to complementary mating features123 of thehandle assembly112. The mating features123,125 can be configured to couple together via, e.g., a snap fit coupling, a bayonet type coupling, etc., although any number of complementary mating features and any type of coupling can be used to removably couple the shaft114 to thehandle assembly112. Although the entire shaft114 of the illustrated embodiment is configured to be detachable from thehandle assembly112, in some embodiments the attachment portion116 can be configured to allow for detachment of only a distal portion of the shaft114. Detachable coupling of the shaft114 and/or theend effector150 can allow for selective attachment of a desiredend effector150 for a particular procedure, and/or for reuse of thehandle assembly112 for multiple different procedures.

Thehandle assembly112 can have one or more features thereon to manipulate and operate theend effector150. By way of non-limiting example, arotation knob126 mounted on a distal end of thehandle assembly112 can facilitate rotation of the shaft114 and/or theend effector150 with respect to thehandle assembly112. Thehandle assembly112 can further include clamping components as part of a clamping system actuated bytrigger122 and firing components as part of a firing system that can also be actuated by thetrigger122. Thus, in some embodiments, movement of thetrigger122 toward astationary handle120 through a first range of motion can actuate clamping components to cause

opposed jaws

152,154 to approximate toward one another to a closed position. Further movement of thetrigger122 toward thestationary handle120 through a second range of motion can actuate firing components to cause the ejection of staples from thestaple cartridge160 and /or the advancement of a knife to sever tissue captured between the

jaws

152,154.

Yet another embodiment of asurgical instrument200 is illustrated inFIG. 7. Like

surgical instruments

Thehandle assembly212 of thestapler200 can have various actuators disposed thereon that can control movement of the stapler. For example, thehandle assembly212 can have arotation knob226 disposed thereon to facilitate positioning of theend effector250 via rotation, and/or atrigger222 for actuation of theend effector250. Movement of thetrigger222 through a first range of motion can actuate components of a clamping system to approximate the jaws, i.e. move theanvil254 toward thecartridge assembly252. Movement of thetrigger222 through a second range of motion can actuate components of a firing system to cause the staples to deploy from thestaple cartridge assembly252 and/or cause advancement of a knife to sever tissue captured between thecartridge assembly252 and theanvil254.

The illustrated embodiments of

surgical stapling instruments

10,100, and200 provide only a few examples of many different configurations, and associated methods of use, that can be used in conjunction with the disclosures provided herein. Although the illustrated embodiments are all configured for use in minimally invasive procedures, it will be appreciated that instruments configured for use in open surgical procedures, e.g., open linear staplers as described in U.S. Pat. No. 8,317,070, can be used in conjunction with the disclosures provided herein. Greater detail on the illustrated embodiments, as well as additional exemplary embodiments of surgical staplers, components thereof, and their related methods of use, that can be used in accordance with the present disclosure include those devices, components, and methods provided for in U.S. Publication No. 2013/0256377, U.S. Pat. No. 8,393,514, U.S. Pat. No. 8,317,070, U.S. Pat. No. 7,143,925, U.S. patent application Ser. No. 14/074,884, entitled “Sealing Materials for Use in Surgical Procedures, and filed on Nov. 8, 2013, U.S. patent application Ser. No. 14/074,810, entitled “Hybrid Adjunct Materials for Use in Surgical Stapling,” and filed on Nov. 8, 2013, U.S. patent application Ser. No. 14/075,438, entitled “Positively Charged Implantable Materials and Method of Forming the Same,” and filed on Nov. 8, 2013, U.S. patent application Ser. No. 14/075,459, entitled “Tissue Ingrowth Materials and Method of Using the Same,” and filed on Nov. 8, 2013, U.S. patent application Ser. No. 14/074,902, entitled “Hybrid Adjunct Materials for Use in Surgical Stapling,” and filed on Nov. 8, 2013, U.S. patent application Ser. No. 14/226,142, entitled “Surgical Instrument Comprising a Sensor System,” and filed on Mar. 26, 2014, each of which is incorporated by reference herein in its entirety.

End Effector Variations

End effectors of the surgical stapling instruments described herein can have one or more features for adjusting an amount of compression applied to tissue captured by the end effector. In some embodiments, the end effector can be configured to create a desired compression profile in tissue captured therein, for example a profile that helps to minimize bleeding, tearing, and/or leakage of the treated tissue. By way of non-limiting example, the desired tissue compression profile can be obtained using variations in a gap between upper and lower jaws of the end effector and/or variations in the orientation, size, and/or shape of staples applied to tissue by the end effector. As described in detail herein, adjunct material(s) used in conjunction with such an end effector can be configured to assist in creating the desired tissue compression profile and/or to accommodate features used to create the desired tissue compression profile.

Any such variations described herein can be used alone or together to provide the desired tissue compression profile. Although exemplary end effectors and components thereof are described in conjunction with a particular surgical instrument, e.g.,

instruments

10,100, and200, it will be appreciated that the end effectors and components thereof can be configured for use with other embodiments of surgical instruments as described herein.

In some embodiments, a staple cartridge disposed within an end effector of a surgical stapling instrument can have a first portion configured to compress tissue captured by the end effector more than a second portion when the end effector is in a closed position. The first portion of the cartridge can be spaced longitudinally and/or laterally from the second portion to create a desired compression gradient. For example, as shown inFIGS. 4 and 8, thestaple cartridge60 can have a stepped tissue contacting surface. In particular, thecartridge60 can have an innertissue contacting surface62 and outertissue contacting surfaces64 that extend upwardly to a taller height than the innertissue contacting surface62. In this way, when theupper jaw54 is in the closed position in close approximation with thecartridge60, theanvil surface58 can be configured to compress theouter surfaces64 more than theinner surface62 due to the taller height of the outer surfaces64. In some circumstances, including circumstances where tissue positioned between theanvil surface58 and thecartridge60 has a constant, or at least substantially constant, thickness, the pressure generated within the tissue can be greater at outer portions of theend effector50 than at inner portions of theend effector50. Whereas a compression gradient generated by thecartridge60 varies in a stepped manner, it will be appreciated by a person skilled in the art that a gradual compression gradient can be generated within the tissue by a gradual increase in height of various portions of thecartridge60. It will also be appreciated that a compression gradient can be obtained by variations in height of theanvil surface58, alone or in combination with height variations of thecartridge60, and that height variations can be spaced laterally and/or longitudinally across theend effector50.

In some embodiments, one or more adjunct materials fixed to an end effector of a surgical stapling instrument can be used to create a desired compression profile in tissue captured by the end effector. Referring now toFIG. 9, a compressible,implantable staple cartridge360 can be formed from one or more adjunct materials as described herein and can be configured to be seated within an end effector of a surgical instrument, e.g., anend effector350. Thecartridge360 can have a height that decreases from a tallest height H1 at adistal end360dthereof to a smallest height H2 at aproximal end360pthereof. In this way, when anupper jaw354 of theend effector350 is in the closed position in close approximation with thecartridge360, anupper jaw354 of theend effector350 can be configured to compress thedistal end360dmore than theproximal end360p.Although the compression gradient created in the captured tissue by thecartridge360 decreases linearly from thedistal end360dto theproximal end360p,it will appreciated by a person skilled in the art that any compression gradient can be created by different shapes of thecartridge360. In at least one embodiment, a thickness of thecartridge360 can vary across its width, similar to thecartridge360.

In some embodiments, staples contained within a staple cartridge of an end effector can be configured to create a desired compression profile within tissue captured by the staples. The desired compression profile can be created in stapled tissue, for example, where staples within the staple cartridge have different unformed staple heights. As shown inFIG. 10, an unformed height H of theexemplary staple70 can be measured from abase74 of the staple70 to a top, or tip, of

legs

72a,72bof thestaple70. Referring now toFIG. 11, which illustrates a cross section of theend effector350, a first group ofstaples370acan have first staple height H1 that is taller than a second staple height H2 of a second group ofstaples370b.The first group of thestaples370acan be positioned in a first portion of thestaple cartridge360, for example in an outer portion, and the second group ofstaples370bcan be positioned in a second portion of thestaple cartridge360, for example in an inner portion. In the illustrated embodiment, thecartridge360, and therefore the compression gradient, can be configured to be symmetrical about aslot367 configured to receive a cutting instrument, e.g., theE-beam86, therethrough. It will be appreciated by a person skilled in the art that the first and second groups of

staples

370a,370bcan be arranged in any pattern and can be spaced laterally and/or longitudinally along thecartridge360. In certain embodiments, a plurality of staple groups, each group having different unformed staple heights, can be utilized. In at least one such embodiment, a third group having an intermediate staple height can be positioned in the cartridge intermediate the first group of staples and the second group of staples. In various embodiments, each staple within a staple row in the staple cartridge can comprise a different staple height. In at least one embodiment, the tallest staple within a staple row can be positioned on a first end of a staple row and the shortest staple can be positioned on an opposite end of the staple row. In at least one such embodiment, the staples positioned intermediate the tallest staple and the shortest staple can be arranged such that the staple heights descend between the tallest staple and the shortest staple, for example.

staples

270a,270b,270c,each having different widths W1, W2, and W3, respectively, although any number of staple groups is possible. As shown, the groups of

staples

270a,270b,270ccan be arranged in circumferential rows, with thestaples270chaving the largest width W1 positioned on an outermost edge of thecartridge260 and thestaples270ahaving the smallest width W3 positioned on an innermost edge of thecartridge260. In other embodiments, staples having a larger crown width can be positioned near an inner most edge of a cartridge and staples having a smaller crown width can be positioned near an outer edge of the cartridge. In still further embodiments, staples along the same row can have different crown widths.

Additionally or alternatively, it may be possible to create a desired tissue compression profile by the creation of different formed (final) staple heights.FIG. 13 illustrates an exemplary embodiment of lines of formed staples470′ installed using a surgical stapling instrument as described herein and configured to apply staples470′ having different formed heights as well as to cut tissue to thereby create acut line494. As shown inFIG. 13, formed heights F1 of a first group ofstaples470a′ in a first row that is the farthest distance away from thecut line494 are greater than formed heights F3 of a third group ofstaples470c′ in a third row that is closest to thecut line494. A second group ofstaples470b′ in a second row that is formed between the first and third rows can havestaples470b′ with a formed height F2 that is between the heights F1, F3. In other embodiments, formed heights of the staples can decrease from an innermost row to an outermost row. In still further embodiments, formed heights of the staples in a single row can increase or decrease from staple to staple.

Referring again toFIG. 11, differences in formed staple heights can be attained by, for example, altering a staple forming distance A. Forming distances A1, A2 can be measured from a seat of

staples

370a,370b,respectively, within thecartridge360, and an apex of a corresponding formingpocket366 of the anvil surface358 when theupper jaw354 is in the closed position. In one embodiment, for example, a first staple forming distance A1 is different from a second staple forming distance A2. Because the forming distance A1 is greater than the forming distance A2, thestaples370aare not compressed as much as thestaples370b,which can alter the formed heights of the

staples

370a,370b.In particular, greater amounts of compression, corresponding to smaller forming distances, can result in staples with smaller formed (final) heights. It will be understood that similar results may be attained in any desired pattern.

Varied tissue compression gradients can be obtained via patterns in staple orientation within a staple cartridge, for example by the patterns illustrated inFIGS. 14 and 15. In the embodiment depicted inFIG. 14,staple cartridge560 can include at least onefirst staple cavity568aand at least onesecond staple cavity568bfor housing staples570 therein. Thefirst cavity568acan be situated on firstlateral side563 of thecartridge560 and thesecond cavity568bcan be situated on a secondlateral side565 of thecartridge560, the first and second

lateral sides

563,565 being separated by aslot567 configured to receive a cutting instrument, e.g., theE-beam86, therethrough. Thefirst cavity568acan define a firstlongitudinal axis569aand thesecond cavity568bcan define a secondlongitudinal axis569b.In the illustrated embodiment, thefirst axis569ais perpendicular, or substantially perpendicular, to thesecond axis569b.In other embodiments, thefirst axis569acan be transverse to thesecond axis569bsuch that

axes

569a,569bcan create an acute or obtuse angle therebetween. In still other embodiments, thefirst axis569acan be parallel to, or substantially parallel to, thesecond axis569b.In some embodiments, at least a portion of the

staple cavities

568a,568bcan overlap, such that staples570 therein can be interlocked when formed. Thecartridge560 can have a plurality of each of the first and

second cavities

568a,568b,which can be arranged in any pattern on first and

second sides

563,565 of thecartridge560, for example in rows extending along both

sides

563,565 of thecartridge560 along a longitudinal axis Lc of thecartridge560. The staples570 housed within the

cavities

568a,568bcan be implanted into tissue in a pattern determined by the orientation and positioning of the

cavities

568a,568b.Thecartridge560, for example, can be used to implant staples570 having different orientations of the staples570 on opposite sides of an incision line created by a surgical instrument carrying thecartridge560.

In other embodiments, for example the embodiment of acartridge660 illustrated inFIG. 15,

staple cavities

668aand668bhaving different orientations can both be disposed on a single lateral side of thecartridge660. As shown inFIG. 15, anaxis669aof thefirst staple cavity668ais perpendicular, or substantially perpendicular, to anaxis669bof thesecond staple cavity668b,both of which are disposed on each of first and second

lateral sides

663,665 of thecartridge660. In other embodiments, the

axes

669a,669bcan form an acute or obtuse angle therebetween, or can be parallel to one another. A plurality of the first and

second cavities

668a,668bcan be aligned in adjacent rows along a longitudinal axis Lc′ of thecartridge660 on each of the first and

second sides

663,665 of thecartridge660. In this embodiment, staples670 housed within the

cavities

668a,668bcan be implanted into tissue in a symmetrical pattern about an incision line created by a surgical instrument carrying thecartridge660. Greater detail on staple patterns, as well as additional embodiments of such patterns, can be found in U.S. Publication No. 2011/0192882, incorporated herein by reference in its entirety.

Exemplary Compositions for Adjunct Materials

Regardless of the configuration of the surgical instrument, the present disclosure provides for the use of implantable materials, e.g., synthetic and/or biological materials, collectively “adjunct materials,” in conjunction with instrument operations. As shown inFIG. 16, theend effector50 can include at least one piece ofadjunct material30 positioned intermediate the lower and

upper jaw members

52,54 and it can be releasably retained to one of thestaple channel56 and/or theanvil surface58. In use, theadjunct material30 and patient tissue can be captured bystaples70 when thestaples70 are fired. Then, theadjunct material30 can be separated from the surgical stapler and can remain in the patient when the stapler is removed from the patient. Exemplary devices and methods for attaching one or more adjunct materials to an end effector of a surgical instrument can be found in U.S. Publication No. 2013/0256377 and U.S. Publication No. 2013/0153641, incorporated herein by reference in their entirety.

Adjunct material used in conjunction with the disclosures provided for herein can have any number of configurations and properties. Generally, they can be made from a bioabsorbable material, a biofragmentable material, and/or a material otherwise capable of being broken down, for example, such that the adjunct material can be absorbed, dissolved, fragmented, and/or broken down 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 assist in wound healing. In other embodiments, the adjunct material can include a therapeutic drug that can be configured to be released over time to aid the tissue in healing, for example. In further various embodiments, the adjunct materials can include a non-absorbable and/or a material not capable of being broken down, for example.

Some particularly advantageous adjunct materials can include porous polymer scaffolds that can be configured to be broken down, for example by exposure to water such that the water attacks the linkage of a polymer of the material. The degraded material can be configured to gel over a wound site to thereby coat the wounded tissue, e.g., wounded soft tissue, which can aid in compressing, sealing and/or generally creating an environment at the wound site that promotes healing of the tissue. In particular, such degradable polymers can allow for the tissue itself to become the weight-bearing component. In some embodiments, the degraded material can include chemoattractant agents that attract natural healing compounds to the wound site. The polymer scaffolds can be configured to have a desired rate of degradation, for example within minutes to hours after attachment to tissue, to thereby assist in the healing process almost immediately after attachment. For more details on porous polymer scaffolds as described herein, see Q. Chen et al., Elastomeric biomaterials for tissue engineering, Progress in Polymer Science 38 (2013) 584-671, incorporated herein by reference in its entirety.

In some embodiments, the porous polymer scaffolds described herein can be physically crosslinked, which can allow for shaping of the polymer into various complicated three-dimensional shapes, e.g., fibers, sheets, films etc., having any desired porosity, surface-to-volume ratio, and mechanical properties. The scaffold can be shaped into a desired form via a number of methods, for example by extrusion, wet spinning, electrospinning, thermally induced phase separation (TIPS), salt leaching/freeze-drying, etc. Where the scaffold is formed into a film or sheet, the film or sheet can have any desired thickness, for example in a range of about 50 to 750 μm or in a range of about 1 to 3 mm, depending on the desired application.

One embodiment of a porous polymer scaffold includes multiple layers, each of which can perform different wound healing functions. In an exemplary embodiment, the scaffold includes three layers. The first layer can be made from polyester carbonate urethane urea (PECUU), the second layer can be made from poly(ester urethane) urea (PEUU), and the third layer can be made from poly(carbonate urethane) urea (PCUU) lysine triisocyanate (LTI) or hexamethylene diisocyanate (HDI). A person skilled in the art will appreciate that the properties of each layer can be optimized to achieve desired results and performance. In some embodiments, the desired properties of the scaffold can be achieved by blending or copolymerizing the material of the third layer or copolymerized with various polymers or copolymers. By way of non-limiting examples, the material of the third layer can be blended with a polyester copolymer, for example polycaprolactone (PCL), polyglycolic acid PGA, poly(D,L-lactic acid) (PDLLA), PGA, and/or polyethylene glycol (PEG). Where the material of the third layer is blended with both the polyester copolymer and the PEG, a ratio of the polyester to the PEG in the third layer can be about 50:50. In another exemplary embodiment, the PCL can be present in a range of about 60-70% weight/volume, the PGA can be present in a range of about 20-30% weight/volume, the PEG can be present in a range of about 50% weight/volume, and the PDLLA can be present in a range of about 10% weight/volume.

The three-layered film can be configured to degrade almost immediately upon attachment to tissue, for example within about 1 to 2 hours after attachment, although each of the three layers can be configured to degrade differently to have different healing benefits. The order, number, and thickness of each of the layers can vary, and can be tailored to create desired degradation and/or compression ratios. In some embodiments, the first, second, and third layers can be formed on top of a base material or substrate, for example on top of PCL, which can be configured to aid in mechanical compression of the wounded tissue.

Another exemplary embodiment of a porous polymer scaffold can be synthesized from polyhydroxyalkanoate (PHA). In an exemplary embodiment, the PHA can be naturally produced from a variety of microorganisms, e.g., Gram-negative or Gram-positive bacteria, or it can be synthesized, e.g., similar to the production of Biopol®, available from Zeneca of London, United Kingdom. Because PHAs are very quick to dissolve, scaffolds made from PHA can begin to degrade within 20 to 30 minutes after attachment to tissue via contact with heat and/or water. Where the PHA scaffold has a higher molecular weight, the degradation time can be higher, for example in a range of about 30 minutes to about 10 hours. The PHA can be formed into a very thin film, for example a film having a thickness of less than 0.1 mm, e.g., in a range of between 50 to 750 μm. In some embodiments, the PHA can be copolymerized and/or blended with one or more additional materials. By way of non-limiting example, the PHA can be copolymerized with hydroxlvalerate (HV), hydroxylbutyrate (HB), and/or hydroxylhexanoate (HH), which can reduce a level or crystallinity and/or brittleness of the PHA. In other embodiments, the PHA can be blended with one or more thermoplastics, e.g., poly(lactic acid) (PLA), PGA, PCL, starch, etc., to thereby customize a molecular weight and resultant mechanical properties of the scaffold. In certain aspects, one or more of the polymers can be a thermoplastic polymer.

In other embodiments, the scaffold can be synthesized from poly(polyol sebacate) (PPS), e.g., from poly(glycerol-sebacate) (PGS). Such scaffolds can be particularly biocompatible and can provide an additional advantage of reducing a risk of infection in addition to promoting healing. Other exemplary embodiments can be synthesized from xylitol-based elastomers, for example polyxylitol sebacates (PXSs), which can offer structural stability over a clinically required period and/or can enter the metabolic pathway slowly without causing rapid fluctuations of blood glucose levels. Scaffolds made from PXS's can be formed into a thicker film to thereby provide greater compression to the wound site, and can be configured to degrade within a range of about 10 hours to 8 days after attachment. Still other exemplary embodiments can be synthesized from poly(glycerol sebacate-co-acrylate) (PGSA), which can promote tissue in-growth into the scaffold, particularly when formed as a fiber, and/or can serve as an anti-bacterial agent. PGSA scaffolds can be useful as a replacement for traditional surgical sutures and staples, and/or can serve as a waterproof sealant for hollow organ anastomoses (e.g., ducts, intestine, etc.), 2D mesh grafts (e.g., treatment of hernias, ulcers, burns, etc.), and/or wound dressings (e.g., hemostatic patches, etc.). The PGSA can be combined with glycerol, which can allow the scaffold to last longer in situ, for example up to 20 days.

In yet another embodiment, the scaffold can be made from poly(ε-caprolactone) (PCL), which can be blended with silk fibroin (SF) and which can be formed into a very thin film. The PCL/SF blend can have highly biocompatible properties and/or can improve cell attachment and/or proliferation to the scaffold. For example, when implanted onto tissue, the scaffold can release fibroin into the tissue to thereby promote faster healing, nearly immediate hemostasis, and/or to attract fibroblasts in greater numbers. The PCL component can further assist in the healing process by providing mechanical compression of the wounded tissue. A higher PCL content can provide better mechanical properties, while a higher SF content can provide better degradation properties. In general, the PCL content can be in a range of about 50 to 90% weight/volume and the SF content can be in a range of about 10 to 50% weight/volume. More details on the properties and manufacturing methods for scaffolds made from PCL and SF can be found in Jun Sik Lim et al., Fabrication and Evaluation of Poly(epsilon-caprolactone)/Silk Fibroin Blend Nanofibrous Scaffold, Biopolymers 97: 265-275 (2012), incorporated herein by reference in its entirety.

In still further embodiments, the scaffold can include PCL coated with a gelatin. The scaffold can be arranged in one or more layers, for example with the PCL serving as a substrate. The PCL can function to increase a mechanical strength of the scaffold and/or can support fibroblast adhesion and cell proliferation. More details on the properties and manufacturing methods for scaffolds made from gelatin-coated PCL can be found in Pengcheng Zhao et al., Biodegradable fibrous scaffolds composed of gelatin coated poly(ε-caprolactone) prepared by coaxial electrospinning, J. Biomed Mater Res 83A: 372-382 (2007), incorporated herein by reference in its entirety.

Table 1 below outlines exemplary molecular weight ranges, approximate absorption times, and average dimensions of films made from the aforementioned porous polymer scaffold materials. It will be appreciated by a person skilled in the art that the ranges provided in Table 1 are not intended to be limiting, and that a molecular weight of any of the polymers described herein can be altered to obtain the desired degradation properties.

TABLE 1

	Average molecular	Approximate
Film	weight in Daltons	absorption times	Average thickness	Average length	Average width

Polyester carbonate	5,000 to 80,000	14 to 60 days	10 μm to 1 mil	25.4 to 100 mm	10.3 to 12.7 mm
urethane urea (PECUU)
Poly(ester	5,000 to 80,000	14 to 60 days	10 μm to 1 mil	25.4 to 100 mm	10.3 to 12.7 mm
urethane)urea (PEUU)
Poly(carbonate	10,000 to 200,000	14 to 60 days	100 μm to 1 mil	25.4 to 100 mm	10.3 to 12.7 mm
urethane)urea (PCUU)	(preferably
	15,000 to 50,000)
Polyhydroxyalkanoate (PHA)	2.107 × 1029	7 to 60 days	100 μm to 1 mil	25.4 to 100 mm	10.3 to 12.7 mm
	to 2.589 × 1029
Poly(polyol sebacate) (PPS)	89,000 and 124,000	7 to 60 days	100 μm to 1 mil	25.4 to 100 mm	10.3 to 12.7 mm
Polyxylitol sebacates (PXS's)	1.47 × 1027	7 to 60 days	100 μm to 1 mil	25.4 to 100 mm	10.3 to 12.7 mm
	to 3.73 × 1027
Poly(glycerol	5.8 × 1026	7 to 60 days	10 μm to 1 mil	25.4 to 100 mm	10.3 to 12.7 mm
sebacate-co-acrylate)	to 7.5 × 1026
(PGSA)
Poly(ε-caprolactone);	25,000 to 325,000	21 to 60 days	10 μm to 1 mil	25.4 to 100 mm	10.3 to 12.7 mm
silk fibroin; scaffold	(SF)	(SF)
(PCL/SF) Blend	4.21 × 1028	2 to 3 years
PCL/SF (50/50)	to 4.81 × 1028 (PCL)	(PCL)
Gelatin coated PCL	3.01 × 1028	7 days (gelatin)	100 μm to 1 mil	25.4 to 100 mm	10.3 to 12.7 mm
(poly (ε-caprolactone)	to 1.98 × 1029	2 to 3 years
	(gelatin)	(PCL)
	4.21 × 1028
	to 4.81 × 1028 (PCL)

Other suitable adjunct materials can include absorbable polyurethanes, e.g., polyurethanes derived from aromatic absorbable isocyanates that can be similar to methylene bis(phenyl isocyanate) (MDI) and chain extender diols. The absorbable polyurethanes can be configured to hydrolytically degrade into safe and biocompatible products upon hydrolysis. Non-limiting examples of hydrolysable aromatic isocyanates that can be used to form the absorbable polyurethanes include glycolate-diisocyante, caprolactone-diisocyanate, glycolate-ethylene glycol-glycolate, glycolate-diethylene glycol-glycolate, lactate-diethylene glycol-lactate, trimester of gycolic acid with trimethylpropane, and tetraester of glycolic acid with pentaerythritol.

Another particularly advantageous adjunct material that can be used in conjunction with the disclosures provided herein are the materials that form the multilayered dressings disclosed in U.S. Publication No. 2006/0257458, incorporated herein in its entirety, which are particularly suited to absorb and retain fluids when compressed, e.g., by the application of staples. Other exemplary, non-limiting examples of synthetic materials that can be used in conjunction with the disclosures provided for herein, e.g., as a buttress, include biodegradable synthetic absorbable polymer such as a polydioxanon film sold under the trademark PDS® or with a Polyglycerol sebacate (PGS) film or other biodegradable films formed from PGA (Polyglycolic acid and various forms thereof, marketed under the trademarks Vicryl, Dexon, and/or Neoveil), PCL (Polycaprolactone), PLA or PLLA (Polylactic acid), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold under the trademark Monocryl), PANACRYL (Ethicon, Inc., Somerville, N.J.), Polyglactin 910, Poly glyconate, PGA/TMC (polyglycolide-trimethylene carbonate sold under the trademark Biosyn), polyhydroxybutyrate (PHB), poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), polydioxanone (PDO) and various forms thereof (e.g., marketed under the trademark PDS) or a blend or copolymerization of any of the above. Blends and/or copolymerizations of any of the aforementioned materials can be tailored to have a desired molecular weight and/or degradation rate.

Some non-limiting examples of biologic derived materials that can be used in conjunction with the disclosures provided for herein, e.g., as a sealant material, include platelet poor plasma (PPP), platelet rich plasma (PRP), starch, chitosan, alginate, fibrin, thrombin, polysaccharide, cellulose, collagen, bovine collagen, bovine pericardium, gelatin-resorcin-formalin adhesive, oxidized regenerated cellulose, regenerated cellulose, mussel-based adhesive, poly(amino acid), agarose, polyetheretherketones, amylose, hyaluronan, hyaluronic acid, whey protein, cellulose gum, starch, gelatin, silk, Progel®, available from Davol Inc. of Warwick, R.I., TachoSil®, available from Baxter of Deerfield, Ill., or other material suitable to be mixed with biological material and introduced to a wound or defect site, including combinations of materials, or any material apparent to those skilled in the art in view of the disclosures provided for herein. Biologic materials can be derived from a number of sources, including from the patient in which the biologic material is to be implanted, a person that is not the patient in which the biologic material is to be implanted, or other animals.

Additional disclosures pertaining to synthetic or polymer materials and biologic materials that can be used in conjunction with the disclosures provided herein can be found in U.S. Pat. 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 Ser. No. 13/710,931, entitled “Electrosurgical End Effector with Tissue Tacking Features,” and filed on Dec. 11, 2012, and U.S. patent application Ser. No. 13/763,192, entitled “Multiple Thickness Implantable Layers for Surgical Stapling Devices,” and filed on Feb. 8, 2013, each of which is incorporated by reference herein in its entirety.

Adjuncts Having Strain Relieving Features

A tissue adjunct can have various configurations, but can generally be configured to contact tissue as the tissue is clamped between a cartridge assembly and an anvil of a surgical stapler. One advantage of tissue adjuncts is their propensity to prevent or minimize leaks, such as fluid or gas leaks. Tissue adjuncts can perform this function by one or more of the following mechanisms: plugging holes or tears that occur at the staple puncture sites; restricting movement of tissue around staple puncture sites to prevent an increase in the size of staple holes and/or to prevent tissue tears; and minimizing strain gradients that occur between constrained tissues within the staple line and free tissue adjacent to the staple line.

In certain aspects, the adjunct material can be used to distribute the compressive clamping force over the tissue, absorb and retain beneficial fluids at the treatment site, improve the purchase of the staples, and/or promote hemostasis. In some embodiments, a first piece of adjunct material can be attached to a cartridge assembly and a second piece of adjunct material can be attached to an anvil; however, any suitable number of adjunct materials can be situated within the end effector.

The tissue adjunct can include various features and be formed from various materials for assisting with sealing of tissue at a staple line and/or for preventing the formation of leaks in the tissue. For example, a tissue adjunct can have a central region configured to be deployed onto tissue and attached thereto via staples. The tissue adjunct can further include an outer region, also referred to herein as a wing region or wing portion, which can be positioned outside of a staple line when the adjunct is stapled to tissue. The wing portion can help to more evenly distribute strain and/or minimize strain gradients across a tissue as the tissue deforms or otherwise expands and contracts during normal bodily functions. In some embodiments, a sealant can be used in conjunction with the adjunct to help seal the stapled tissue. The sealant can be introduced into a patient in a first, liquid state and can be configured to transition to a second, hardened or solid state after a predetermined amount of time. When the sealant is in the first, liquid state, the sealant can seep into the adjunct and/or the staple line and then harden therein, thereby facilitating complete sealing of the tissue. The adjunct and the sealant can thus cooperate to provide a better, more complete seal of the staple line than if only the tissue adjunct or the sealant were used.

Exemplary adjuncts having central and wing regions are shown deployed onto tissue inFIGS. 17A and 17B. As shown inFIG. 17A, an adjunct1000 can include a central1002 for receiving staples therethrough and awing portion1004 adjacent to thecentral region1002. Thecentral region1002 of the adjunct1000 can be sized and shaped to correspond to a size and shape of acartridge assembly52 and/or an anvil (not shown). For example,FIG. 17A illustrates an adjunct1000 having acentral region1002 that corresponds in size and shape to a tissue-contacting surface of thecartridge assembly52. That is, thecentral region1002 can be substantially equal in size to the tissue-contacting surface. Thecentral region1002 of the adjunct1000 shown inFIG. 17A can have a substantially elongate rectangular shape defined by proximal and

distal edges

1002p,1002dand first and second

lateral edges

1002a,1002b.Theproximal edge1002pof thecentral region1002 can terminate in aproximal mating feature1006 for coupling to adistal end14dof ashaft14 of astapler10. At least two of the remaining three edges of thecentral region1002 can include awing portion1004 extending therearound and forming a perimeter of the adjunct1000. For example, as shown inFIG. 17A, thewing portion1004 of the adjunct1000 can extend around the first and second

lateral edges

identical adjuncts

1000,1000′ can be stapled to tissue, as shown inFIG. 17B, and in certain aspects, these

adjuncts

1000,1000′ can be substantially the same in size, shape, and configuration.

Another embodiment of an adjunct1010 is shown inFIG. 18 and also includes a central region and wing region. In this embodiment, awing portion1014 has a plurality ofopenings1018 formed therein which can allow the wing portion1014to flex with the tissue T during expansion and contraction of the tissue T. Theopenings1018 can have various sizes, shapes, and configurations, and can be circular, oval, rectangular, etc., and can be positioned at various locations across thewing portion1014. In the illustrated embodiment, theopenings1018 are slits positioned in multiple rows, the rows being substantially parallel to the longitudinal axis LC of acentral region1012. A longitudinal axis of theslits1018 can be parallel to a longitudinal axis LS of thestaples1008. A number of longitudinal rows and a number ofopenings1018 disposed in each row can vary. In the illustrated embodiment, a row adjacent to thecentral region1012 can have a smaller number ofopenings1018 than a row adjacent to anoutermost edge1014aof thewing portion1014. For example, the row adjacent to thecentral region1012 can have about threeopenings1018 formed therein while the row adjacent to theoutermost edge1014aof thewing portion1014 can have about fouropenings1018 formed therein. In this way, a flexibility of thewing portion1014 can increase from thecentral region1012 to the lateral edge and can further facilitate distribution of strain across the tissue T.

FIGS. 19A and 19B illustrate another embodiment of a tissue adjunct having wings for distributing strain across the tissue.FIG. 19A illustrates an adjunct1020 having acentral region1022 and awing region1024, both regions being formed from a plurality of layers. As in the previous embodiments, thecentral region1022 can have a substantially rectangular shape. A top layer of material can define thecentral region1022 and both

regions

1022,1024 can be formed from a plurality of layers. Thecentral region1022 can have a substantially rectangular shape, but can be shaped in other ways. As shown inFIG. 19A, a top layer ofmaterial1026tcan define the central region and can be formed from a flexible material, such as PDS®, PGA, Neoveil®, ORC or other polymers and biologically derived material constructs or combinations disclosed herein. Material geometry and structure (material thickness, fiber orientation, polymer chain orientation, hole patterns, etc.) may be used to create desired isotropic or anisotropic deformation characteristics. A bottom layer of material1026bcan also be substantially flexible, and in certain aspects can have a greater flexibility than thetop layer1026t.The bottom layer1026bcan have a shape that corresponds to a shape of thetop layer1026t,and is shown having a substantially rectangular shape. The bottom layer1026bcan have a larger surface area than thetop layer1026tsuch that the bottom layer1026bextends beyond lateral edges of thetop layer1026t.As shown, lateral edges of the bottom layer1026bcan be scalloped, having a plurality ofsemicircular protrusions1028 along thewing portion1024. These semicircular protrusions can be spaced at equal distances apart along the edges, or can be spaced in groups of two, three, four, and the groups of protrusions can be disposed at equal distances apart along the edge. When the adjunct1020 is stapled to tissue, thetop layer1026tof material1026twill be positioned away from and will not directly contact the tissue, while the bottom layer1026bwill directly contact tissue. Additionally, the protrusions can be positioned away from the staple rows and can distribute a strain across the tissue T to prevent formation of leaks. The bottom layer1062bmay be formed from a flexible material, such as PDS®, PGA, Neoveil®, ORC or other polymers and biologically derived material constructs or combinations disclosed herein. Material geometry and structure (material thickness, fiber orientation, polymer chain orientation, hole patterns, etc.) may be used to create desired isotropic or anisotropic deformation characteristics. In an embodiment, at least one of top layer1062tand bottom layer1062bis at least partially comprised of PDS® to aid in attachment of adjacent layers. In an embodiment, both the top layer1062tand bottom layer1062bare created from absorbable materials.

The adjunct material can be constructed in various ways. For example, the adjunct material can be formed from a continuous material. That is, as shown inFIG. 19B, the adjunct1020 can include a single layer with thecentral region1022 and thewing portion1024 having the plurality ofprotrusions1024 for distributing a strain. In other aspects, the adjunct can include more than two layers of material. For example, one or more intermediate layers of material (not shown) can be positioned between the top layer and the bottom layer and can be more rigid than the top and bottom layers. The layers can be coupled together using known manufacturing techniques, such as lamination, adhesive, etc. Theprotrusions1028 on thewing portion1024 of the adjunct can also be formed using known manufacturing techniques, such as laser cutting, stamping, punching, etc.

Another exemplary adjunct is shown inFIG. 20 and includes a wing region having a varied geometry. As shown, an adjunct1020′ can have awing region1024′ extending around a perimeter of thecentral region1022′ and can have a plurality of surface features1028′ formed therein and spaced evenly along thewing region1024′. The surface features1028′ can be generally shaped as a boomerang and can include anelbow1023′ and first and second arms1025′,1027′ extending therefrom. As shown inFIG. 20, theelbow1023′ can be positioned alongedges1022a′,1022b′,1022c′of thecentral region1022′ while terminal ends1025t′,1027t′ of the arms1025′,1027′ can be positioned at an outer edge of thewing region1024′. In this way, a thickness of thewing region1024′in a direction transverse to a longitudinal axis of thecentral region1022′can vary and a thickness of thewing region1024′ in a direction parallel to the longitudinal axis of thecentral region1022′can also vary. These surface features1028′can be formed by removing a portion of theadjunct material1020′ using known manufacturing techniques, such as laser cutting, stamping, punching, etc.

FIGS. 21A-21C illustrate adjunct material including wing portions with modified edges. For example, awing portion1034 of anadjunct1030 ofFIG. 21A can have an outer edge in the shape of a sine wave withpeaks1034pandvalleys1034valong its length so that thewing portion1034 is atraumatic and does not increase a likelihood of forming leaks in tissue. Awing portion1034′ ofFIG. 21B includes a first material1036′ forming acentral region1032′ and thewing portion1034′, thewing portion1034′ having curved edges which loop around and extend toward thecentral region1032′, and back toward the edge forming anoblong opening1035′. In certain aspects, a second material1038′ is disposed in the oblong, teardrop shapedopenings1035′, such as by being laminated to the first material1036′ to form the adjunct1030′. A thickness of this second material1038′ can vary from a thickness of the first material1036′. For example, the thickness of the second material1038′ can be less than the thickness of the first material1036′, as shown. Awing portion1034″ ofFIG. 21C can have a plurality ofopenings1035″ formed therein, such as triangular shaped openings, that can form protrusions1038″ similar to thoseprotrusions1028 shown inFIG. 19B, but the protrusions1038″ can have corners rather than rounded edges. The

adjuncts

1030,1030′,1030″ ofFIGS. 21A-21C can be formed from different materials, such as any flexible or stretchable polymer material described herein. In use, any one of the

adjuncts

1030,1030′,1030″can be stapled to tissue and any of the respective wing portions can extend beyond the staple line. A shown inFIG. 21D, the adjunct1030 can be stapled to tissue T and thewing portion1034 can be positioned outside of thestaples1008 which form a staple line and thecentral portion1032 can be positioned inside of the staple line. In certain aspects, as the tissue expands and contracts, the adjuncts can stretch or flex in a direction transverse to the staple rows or can be configured to stretch in multiple directions, such as along an outer surface of the tissue T as shown. A person skilled in the art will appreciate that the edges of the wing portions can be shaped in other ways than the illustrated embodiments.

FIGS. 22A-22C illustrate another embodiment of adjunct material including a wing portion with modified edges. As shown inFIG. 22A, anadjunct material1040 can be woven. Acentral region1042 of the adjunct1040 can be formed from a woven material of higher density than a woven material at awing portion1044 of the adjunct1040. In other aspects, a less dense woven material can encase a denser woven material on all sides, as shown inFIG. 22B. In both embodiments, thewing portion1044 can have soft,atraumatic edges1046 that have a decreased likelihood of puncturing or otherwise damaging the tissue and causing holes to form therein. The adjunct1040 can be configured to wick and/or absorb liquid therein. For example, in the embodiment ofFIG. 22C, atop layer1048t′ of material of an adjunct1040′ is shown positioned over a bottom layer ofmaterial1048b′, liquid1047′ being wicked through the top layer of material and into a space between the top andbottom layers1048b′,1048t′. These adjunct materials can be formed from various woven materials known in the art, such as ETHISORB® (Ethicon, Inc., Somerville, N.J.). In one embodiment,central region1042 may be a film comprised of solid, but deformable absorbable material.

An adjunct material for use with a stapler that deploys variable thickness staples is shown inFIGS. 23A-23D. As shown, a thickness of an adjunct1050 can vary from acentral axis1056 to an outer edge of the adjunct1050 in a lateral direction indicated by arrows. That is, the adjunct1050 can have a decreasing/tapering thickness from thecentral axis1056 of the adjunct1050 to the outer edge thereof in the lateral direction. As in the previous embodiments, theadjunct material1050 can include acentral region1052 andwing portion1054. The adjunct1050 can include anelongate slot1058 formed along thecentral axis1056 of the adjunct1050 and having a size and shape that corresponds to a size and shape of a cutting member (not shown). In the illustrated embodiment, theelongate slot1058 has a substantially rectangular shape.FIGS. 23B and 23C provide end views of acartridge assembly52 and ananvil54 having a varying thickness in a lateral direction such that thestapler10 can deploy staples (not shown) of varying heights. As shown, a thickness TO of theanvil54 near the cutting member slot can be greater than a thickness TE of theanvil54 near its lateral edge. The adjunct1050 can be coupled to thecartridge assembly52 and/or to theanvil54 with at least thecentral region1052 of the adjunct1050 directly contacting the tissue-contacting

surface

60,58 of thecartridge assembly52/anvil54. The tissue-contactingsurface58 of theanvil54 can include one or more mating points1057 attaching the adjunct1050 to theanvil54, as shown. Thewing portion1054 of the adjunct1050 can be folded around thecartridge assembly52 and/or theanvil54 and attached thereto, as will be described in greater detail below. In this way, a tissue-contactingsurface1053 of the first adjunct1050 can be substantially planar and can be disposed parallel to atissue contacting surface1053′ of the second adjunct1050′ disposed on thecartridge assembly52. When the

adjuncts

1050,1050′ are stapled onto tissue, as shown inFIG. 23D, the wing portion of the adjunct1050 can be disposed between thestaples1008 and extend toward a cut terminal end TE of the tissue T, while a second portion of the adjunct1050 can extend away from the cut terminal end TE of the tissue T and distribute strain to the tissue T, similar to the wing portions described above. The adjunct1050′ can have similarly positionedportions1052′,1054′, as shown.

Any of the adjunct materials can include various features for increasing friction between the adjunct material and the tissue to ensure that the adjunct material remains in a desired position. For example,

adjuncts

1060,1060′ inFIGS. 24A and 24B include a plurality of

teeth

1061,1061′ formed on a tissue-contacting surface thereof and terminating in

points

1063,1063′ that can penetrate into tissue. As shown, the plurality of

teeth

1061,1061′ can be spaced at equal distances apart in the lateral direction of the adjunct1060,1060′. The

teeth

1061,1061′ can be formed in the adjunct1060,1060′ using various known manufacturing techniques, such as via compression molding, cut/stamping, punching, etc. For example, theadjunct1060 ofFIG. 24A can be compression molded while the adjunct1060′ ofFIG. 24B can be formed from stampingslits1065′ into material to form theteeth1061′. The gaps between the

teeth

1061,1061′ can push into tissue T and create a lock that prevents sliding of the adjunct1060,1060′, as inFIG. 24C which illustrates multiple rows ofadjuncts1060′. In another embodiment shown inFIG. 25A, the adjunct1060″ can include a plurality ofmicropillars1063″ formed on a tissue-contacting surface thereof, themicropillars1063″ being shaped as needles configured to penetrate into tissue T. Theteeth1063 and/ormicropillars1063″ can directly penetrate into the tissue T as shown inFIGS. 24D and 25B and can thereby prevent the adjunct1060,1060″ from sliding relative to thestaples1008 as the tissue T expands and contracts. In certain aspects, themicropillars1063″ can have a diameter D1 in the range of about 0.01 to 0.50 mm and a height H1 in the range of about 0.05 to 0.50 mm.

Another embodiment of an adjunct material is shown inFIGS. 26A-26C. In this embodiment, an adjunct material such as theadjunct1000 ofFIGS. 17A and 17B is used in conjunction with anose extension member1070 that can be coupled to ananvil54 and/or acartridge assembly52 of asurgical stapler10. As shown inFIG. 26A, adistal end1004dof the adjunct1000, that is, thedistal end1004dof thewing portion1004 can terminate at or proximal to adistal-most end52dof thecartridge assembly52. As shown inFIG. 26B, adistal end1004dof the adjunct1000, that is, thedistal end1004dof thewing portion1004 can terminate at or proximal to adistal-most end54dof theanvil54. Thenose extension member1070 can be added onto thecartridge assembly52 and/or theanvil54 to replace or supplement a distal portion of theadjunct material1000. Aproximal end1070pof thenose extension member1070 can have acutout1072 formed therein and sized so as to not obstruct or cover a slot formed in theanvil54 for receiving a cutting member (not shown). Thecutout1072 can define first and

second extension arms

While features of the adjunct described above were illustrated as separate embodiments, an adjunct can have any combination of features described above.

Mechanisms for Attaching and Releasing Adjuncts from an End Effector

Various mechanisms can be used to attach and then release an adjunct having wings from an end effector, e.g. acartridge assembly52 or ananvil54. While the embodiments described below include features formed on ananvil54, any of these features can be formed on acartridge assembly52 for mating an adjunct to thecartridge assembly52.FIGS. 27A-27B illustrateadjunct material1000′,1000″ having mating features keyed to corresponding mating features formed on ananvil54. More specifically,FIG. 27A shows an adjunct1000′ having a plurality ofcylindrical protrusions1003′ formed on asurface1007′ that is oriented away from a tissue contacting surface1005′ of the adjunct1000′. WhileFIG. 27A illustrates threecylindrical protrusions1003′ spaced apart along an axis parallel to a longitudinal axis LA of theanvil54, any number ofprotrusions1003′ can be formed at various locations along the adjunct1000′. Alateral surface54L of theanvil54 can have a plurality ofdepressions53 configured to receive the plurality ofprotrusions1003′ from the adjunct1000′ therein. In one embodiment, a height (not shown) of thecylindrical protrusions1003′ can vary, and can be in the range of about 0.25 to 1.00 mm, the height measured perpendicular to thesurface1007′ of the adjunct1000′. Theprotrusions1003′ formed on the adjunct1000′ can have other sizes and shapes. As shown inFIG. 27B, in another embodiment, an adjunct1000″ can have a single elongaterectangular protrusion1003″ extending parallel to the longitudinal axis LA of theanvil54. A lateral surface of theanvil54 can also include a corresponding elongaterectangular depression53′ for receiving therectangular protrusion1003″ therein when the adjunct1000″ is folded around theanvil54. A height (not shown) of therectangular protrusion1003″ can also vary, but can be in substantially the same range as the height of thecylindrical protrusions1003′ described above. While only a firstlateral surface54L of theanvil54 is shown inFIGS. 27A and 27B, a person skilled in the art will appreciate that identical protrusion(s) can be formed on a second lateral surface (not shown) of theanvil54. Similarly, identical depression(s) can be formed on a second lateral surface (not shown) of theadjuncts1000′,1000″.

An adjunct can be coupled to an anvil/cartridge assembly in other ways. As shown inFIGS. 28A and 28B, a strand ofsuture1003′″ can couple the adjunct to theanvil54. Thesuture1003′″ can extend from the firstlateral surface54L of theanvil54, across the tissue-contacting surface of the adjunct, and to the secondlateral surface55L of theanvil54. First andsecond depressions53′″,55′″ can be formed in the first and second lateral surfaces of theanvil54, and a first terminal end of thesuture1003′″ can be received in thefirst depression53′″ and a second terminal end can be received in thesecond depression55′″. A length of thesuture1003′″ and/or a size of thedepressions53′″,55′″ can be selected so that thesuture1003′″ is taught when the terminal ends of thesuture1003′″ are positioned within thedepressions53′″,55′″. As a cuttingmember59 advances through theanvil54 during and/or after thestaples1008 are deployed into the tissue T, as shown inFIG. 28B, the cuttingmember59 can sever thesuture1003′″, causing the terminal ends of thesuture1003′″ to slide out of thedepressions53′″,55′″ and thereby releasing the adjunct from the anvil.FIGS. 29A and 29B illustrate the strand ofsuture1003′″ extending around ananvil54 and coupling a multi-layer adjunct1020 to theanvil54. As in the previous embodiment, advancement of the cutting member (not shown) relative to theanvil54 can sever thesuture1003′″ and release thesuture1003′″ from thedepressions53′″,55′″ in theanvil54 to release the adjunct1020. As will be appreciated by a person skilled in the art, any number of strands of suture can be used to couple the adjunct to one of thecartridge assembly52 and theanvil54 and the depressions formed therein can vary so long as they are configured to receive a portion of the suture therein.

FIGS. 30A-30B illustrate other mechanisms for attaching an adjunct to an anvil/cartridge assembly. In this embodiment, theanvil54 of asurgical stapler10 includes a cuttingmember59 that can advance within theslot61, referred to as a longitudinal track, and can move between proximal and

distal ends

61p,61dof thetrack61. A driver1081 including first and second elongate members (not shown) can be disposed in thelongitudinal track61, as inFIG. 30B. Three cylindrical protrusions (not shown) extend from the elongate members and intodepressions53″″,55″″ formed in both lateral surfaces of theanvil54, but there can be any number of protrusions spaced along the driver and having various other shapes. As shown inFIG. 30C, afirst driver1081acan be generally elongate and can have a plurality ofprotrusions1083, such as threeprotrusions1083, oriented transverse to a longitudinal axis of the driver, theprotrusions1083 being cylindrical shaped. A wing portion1084 of anadjunct material1080 can be disposed around a lateral surface of theanvil54 and can include a plurality ofprotrusions1083′ oriented transverse to the longitudinal axis LA of theanvil54 when theadjunct material1080 is coupled thereto. As shown inFIG. 30D, theadjunct material1080 can have a first set ofprotrusions1083′ for mating with the first lateral surface of theanvil54 and a second set ofprotrusions1083″ for mating with the second lateral surface of theanvil54. Prior to use, thefirst driver1081acan be positioned on a first lateral wall of thetrack61 and thesecond driver1081bcan be positioned on a second lateral wall of thetrack61. A proximal end of each

driver

1081a,1081bcan have an angled

portion

1085p,1087psuch that when the

drivers

1081a,1081bare disposed in thetrack61, a width W1 between the

drivers

1081a,1081bat a proximal end of thetrack61 is greater than a width W2 between the

drivers

1081a,1081bat and/or distal to theprotrusions1083′, the width being measured transverse to the longitudinal axis LA of theanvil54 as shown inFIG. 30E. Additionally, the width W2 between the

drivers

1081a,1081bdistal to theproximal end61pof thetrack61 can be less than a width WC of the cuttingmember59. In this way, the cuttingmember59 can be advanced toward thedistal end54dof theanvil54 and can increase a width between the

drivers

1081a,1081band theprotrusions1083 can push the correspondingprotrusions1083′ on the adjunct1080 off of and away from the anvil as inFIG. 30F, thereby releasing the adjunct from theanvil54. In certain aspects, the adjunct1080 can be biased to a flattened, substantially planar configuration such that when the cuttingmember59 advances within thetrack61 and exerts a force on the

drivers

1081a,1081b,the adjunct1080 is more able to release from theanvil54.

A loading mechanism for loading an adjunct onto an anvil/cartridge assembly is shown inFIGS. 31A-3B. Aloading mechanism1090 can have various sizes, shapes, and configurations, and can include a firstcurved arm1092aand a secondcurved arm1092bhaving a radius of curvature that corresponds to a radius of curvature of the first and second lateral surfaces54L,55L of theanvil54 and the

arms

1092a,1092bcan terminate in

angled features

1093a,1093bthat can be grasped by a user. Theloading mechanism1090 can have aplanar base1094 from which each of the first and second

curved arms

angled features

1093a,1093bof the curved arms away1092a,1092bfrom one another, leaving theanvil54 loaded with the adjunct1000 as inFIG. 31C.

Another exemplary loading mechanism is shown inFIGS. 32A-32C. Aloading mechanism1090′ can be packaged as a kit along with an end effector of a stapler. Alternatively,loading mechanism1090′ may be packaged separately. As inFIG. 32A, theanvil54 andcartridge assembly52 of theend effector50 can include anadjunct material1000 preloaded thereon or in another non-illustrated embodiment, theadjunct material1000 can be fixed to theanvil54 and thecartridge assembly52 after being removed frompackaging1100. Thisloading mechanism1090′ can be configured to wrap thewing portion1004 of the adjunct1000 around the lateral surfaces54L,53L of the anvil/

cartridge assembly

54,52 such that the wing portion is passively coupled to the anvil/

cartridge assembly

54,52. As shown inFIG. 32B, theloading mechanism1090′ can be configured to contact the central region (not shown) of the adjunct1000 against the tissue-contacting surface of the anvil/

cartridge assembly

54,52 and, if needed, can be configured to shape the wing portion (not shown) around theanvil54. Theloading mechanism1090′ can be formed of a single molded material having anupper retaining portion1104 and alower retaining portion1102, the retaining portions having a channel (not shown) sized and shaped for receiving the anvil/

cartridge assembly

54,52 therein. A shape of the channel can be substantially similar to the shape of theloading mechanism1090 previously described and can include any of the same features, such as the track extension. The upper and

lower retaining portions

1104,1102 can be disposed at an angle θL relative to one another, the angle being in the range of about 10 to 40 degrees. Asupport member1106 can extend between a lower surface of theupper retaining portion1104 and an upper surface of thelower retaining portion1102 such that the angle θL between the retaining

portions

1102,1104 is fixed. Thesupport member1106 can be a substantially solid member, as shown, so as to provide rigidity to theloading mechanism1090′. A first end of thesupport member1106 can terminate in agrasping feature1108, and thegrasping feature1108 can have first and second

planar surfaces

1108a,1108bconfigured to be grasped by a user, such as between a thumb and finger of a user. Thegrasping feature1108 can further include one or more surface features1110 for increasing friction between a user's fingers. A longitudinal axis of thegrasping feature1108 can be oriented perpendicular to a longitudinal axis of thestapler10 or can be parallel to the longitudinal axis of thestapler10. In use, a user can grasp thegrasping feature1108 and position distal ends1102d,1104dof the retaining portions adjacent to proximal ends ends52p,54pof thecartridge assembly52 and theanvil54. A user can advance the distal end of theloading mechanism1090′ toward the proximal end of theend effector50, as shown inFIG. 32B, and the retaining

portions

1102,1104 can slide along the anvil/

cartridge assembly

54,52 and force theadjunct material1000 around the lateral surfaces thereof, as shown inFIG. 32C. This can temporarily secure thewing region1004 along the lateral surfaces of thecartridge assembly52 and theanvil54. With thewing region1004 so positioned, a user can retract theloading mechanism1090′ in the opposite direction, distally away from theend effector50, leaving theend effector50 prepared for insertion into a patient. While reference is made to a singleadjunct material1000 loaded onto theanvil54,adjunct material1000′ can similar be loaded onto thecartridge assembly52. Theadjunct material1000, such as the material shown inFIGS. 32A-32C, can be a shape memory material such that the adjunct1000 is biased to a substantially straightened configuration. That is, when theend effector50 is positioned inside of the patient, the wing regions can automatically move back to the substantially straightened configuration prior to being deployed off of theend effector50 and onto tissue.

Delivering Adjuncts into a Patient

End effectors having one or more adjuncts coupled thereto can be delivered into various areas of a patient, such as a chest cavity, stomach, etc. As will be appreciated by a person skilled in the art, an adjunct can be delivered through an access port, such as a trocar extending into the patient. Any of the adjuncts herein can include features that assist with delivery of the adjunct into a patient's body. For example,FIG. 33A illustrate an adjunct1000 having a solidcentral region1002 and meshwing region1004 coupled to ananvil54 of asurgical stapler10. While asingle adjunct1000 is shown coupled to theanvil54, another adjunct1000′ can be coupled to thecartridge assembly52 prior to inserting theend effector50 into a patient's body. A distal portion of the adjunct1000, such as adistal portion1004dof thewing region1004, can be configured to guideproximal portions1004pof thewing region1004 around the lateral surfaces (not shown) of theanvil54 so as to minimize width of the adjunct material, as shown inFIG. 33B. This can facilitate insertion of theend effector50 and the adjunct1000 into an access port, such as aport1202 formed in atrocar1200, because a width of the anvil/

cartridge assembly

54,52 including the adjunct1000 thereon will be about the same as a width of the anvil/

cartridge assembly

54,52 without an adjunct. In certain aspects, thisdistal portion1004dof thewing region1004 can be formed from a more rigid material than remaining portions of thewing region1004 to help guide theadjunct material1000 into theport1202.

Stapling Adjuncts onto Tissue

An adjunct material can include features facilitating multiple firings of staples along tissue.FIG. 34A illustrates anembodiment1300 of anend effector50 having first and second

adjunct materials

1400,1400′, the firstadjunct material1400 being coupled to theanvil54 and the secondadjunct material1400′ being coupled to thecartridge assembly52. As shown, each of the

adjunct materials

1400,1400′ can include multiple layers, and the layers can have various widths in the direction transverse to a longitudinal axis (not shown) of the anvil/

cartridge assembly

54,52. A first tissue-contacting

layer

1402,1402′ of each adjunct1400,1400′ can be positioned adjacent to tissue (not shown) when tissue is grasped between theanvil54 and thecartridge assembly52. In certain aspects, the first tissue-contacting

layer

1402,1402′ can be formed from a material configured to seal around a staple line, such as an elastomeric material. The first tissue-contacting

layer

1402,1402′ can have a width W5 in a direction transverse to the longitudinal axis LA of theanvil54 that is substantially equal to a width WA of theanvil54, or the width W5 of thefirst layer1402 can be less than the width WA of theanvil54. As shown inFIG. 34A, the first tissue-contactinglayer1402 can include afirst portion1402apositioned on a first side of the cuttingmember slot54sand asecond portion1402bpositioned on a second side of the cuttingmember slot54srather than being formed from a continuous piece of material. In other aspects, thefirst layer1402 can be a single continuous piece of material. A

second layer

1406,1406′ can be positioned closer to the tissue-contacting surface of theanvil54 and can be formed from a substantially rigid material. As shown, a width W6 of thesecond layer1406 can be greater than the width WA of theanvil54. This

second layer

1406,1406′ can help prevent stretching of the tissue T near thestaples1008. A

third layer

1408,1408′ can be positioned closest to the tissue-contacting surface of theanvil54 such that the

second layer

1406,1406′ is sandwiched between the first and

third layers

1402,1402′ and1408,1408′. The

third layer

1408,1408′can have a width W7 that is greater than the width WA of theanvil54, but less than the width W6 of thesecond layer1406, as shown. This

third layer

1408,1408′ can be semi-rigid to help relieve strain on tissue T as the tissue T expands and contracts. A longitudinal length of the layers can also vary, the length being measured in the direction transverse to the widths. Preferably, the

third layer

1408,1408′ has a longest length measured along the longitudinal axis of theanvil54 compared to a longitudinal length of each of the first and

second layers

1402,1402′,1406,1406′. As shown inFIG. 34B,

multiple adjuncts

1400,1400′,1400″ can be sequentially deployed onto tissue in a row and the longitudinal lengths of the layers can result in

regions

1410a,1410bwhere thefirst layer1402 of one adjunct1400 overlaps with afirst layer1402′ of another adjunct1400′. In this way, thestaples1008 can still penetrate through these overlapping regions than if multiple, e.g. three or

more layers

1402,1406,1408 were positioned there.FIG. 33C illustrates two

adjuncts

1400,1400′ stapled onto the tissue T at about a 90 degree angle relative thereto, the first adjunct1400 having a first terminal end and the second adjunct1400′ having a second terminal end. The first and second terminal ends form theoverlapping region1410a,as shown. These

adjuncts

1400,1400′ can be used to allow a user to deploy adjuncts to accommodate various geometries of tissue. These

multilayer adjuncts

1400,1400′ can vary in any number of ways. While the

layers

1402,1406,1408 can have various thicknesses, in the illustrated embodiment thesecond layer1406 has a smaller thickness than a thickness of each of the first and

third layers

1402,1408. For example, thefirst layer1402 can be in the range of about 3 to 15 mm, thesecond layer1406 can be in the range of about 5 to 20 mm, and thethird layer1408 can be in the range of about 3 to 20 mm. In certain aspects, these

layers

1402,1404,1406 and1402′,1404′,1406′ can be laminated together prior to being coupled to the anvil/

cartridge assembly

54,52. In certain aspects,

layers

1406 and1406′ may be at least partially comprised of an absorbable material such as PDS®.

Reinforcing Tissue with Sealant and Adjuncts

Any of the adjuncts herein can be used in conjunction with a sealant to help maintain a seal around staples as the tissue expands and contracts following a surgery. A sealant can have various formulations and differing viscosity and curing behavior. Generally, a sealant can be made from a biocompatible and bioabsorbable material that can be configured to transition from a first, liquid state to a second, hardened state via a curing process, such as a polymerization reaction. The first state can be a softened state, e.g., a fluid, a gel, a foam, etc. and the second state can be a hardened state, e.g., a solid, a rigid member, etc. When the sealant is in the first, softened state, the sealant can flow through the delivery tube and into the sealing cuff, as described in greater detail below. The sealant can transition from the first, softened state to the second, hardened state after a predetermined amount of time. In certain aspects, the sealant can be formed from biologic material. In some embodiments, the sealant can assist in wound healing by releasing various chemical compounds, during and/or after curing of the sealant in a patient's body. By way of non-limiting example, the sealant can be configured to release a therapeutic drug, such as promoters of wound healing (e.g., transforming growth factor-beta, etc.), antibacterial agents (e.g., triclosean, ionized silver, etc.), and other known agents over time to aid the tissue in healing near the location of the sealant in a body. In one embodiment, a fibrin sealant can include two reactive components combined immediately prior to delivery into a patient, such as Thrombin and a biologically active component (BAC2), Fibrinogen and Factor XIII In certain aspects, the components can be provided in a 5:1 volumetric ratio of BAC2 to Thrombin. In an alternative embodiment, the material may be the fibrin sealant sold under the trade name Evicel®. In another embodiment, the sealant can be blood, such as autologous blood.

FIG. 35A illustrates the adjunct ofFIG.17B

having sealant

1500 delivered thereon. As shown, thesealant1500 can be delivered so that it substantially covers the central1002 andwing regions1004 of the adjunct1000 or in another embodiment (not shown), thesealant1500 can be selectively delivered onto only thecentral region1002 and not onto thewing region1004.

Thesealant1500 can be delivered to an adjunct in other ways, and need not be delivered to an outer surface of the adjunct1000. For example,FIG. 35B illustrates

multilayer adjuncts

1700,1700′ stapled onto tissue T. The

layers

1702,1704 can be formed from various materials, but in the illustrated embodiment include afirst layer1702 of fibrous scaffold positioned adjacent to the tissue T and asecond layer1704 consisting of an elastic film. Adelivery tool1706 having aninjection needle1708 can have asealant1500 disposed therein and can penetrate into thefirst layer1702 of fibrous scaffold. Thesealant1500 can be delivered to thisfirst layer1702, as inFIG. 35C and theinjection needle1708 can be removed from the patient's body. Thesealant1500 can bind directly onto the tissue T and/or may be held in firm apposition to the tissue bylayer1704, and as in other embodiments, can have a

wing region

1704,1704′ that distributes a strain to tissue beyond thestaples1008 at the staple line. When the sealant is Evicel®, the material forms a fibrin clot from fibrinogen. Without a loss in generality, other sealants form a hardened sealing structure by different mechanisms that are useful for sealing leak pathways. The combination ofsealant1500 andadjunct material1700 can prevent formation of leaks as the tissue T expands and contracts. Theadjuncts1700′ andlayers1702′,1704′ can be substantially similar to the adjunct1700 and1702,1704 layers previously described.

A sealant can be used to reinforce tissue in other ways. For example,FIGS. 36A-36C illustratesealant1500 being delivered to achest cavity1800 of a patient. As shown inFIG. 35A, asystem1900 for delivering asealant1500 can include a container orcanister1902 for receiving components A, B, C of asealant1500 therein. In certain aspects, the components A, B, C can include acid solubilized collagen A, fibrinogen B, and thrombinC. A trocar1200 can extend through anincision1904 formed in apatient1906 and into thechest cavity1800. Anapplicator tool1908 can have ashaft1910 extending through thetrocar1200, adistal end1910dof theshaft1910 terminating in the chest cavity. A handle assembly can be formed on a proximal end1910pof theshaft1900 and can be configured to be grasped be a user. Thehandle assembly1912 can be a pistol-grip type handle assembly and can include one or more actuators, such as alever1914 that can be pivoted to actuate thedevice1908. Thecanister1902 and theapplicator tool1908 can be coupled together in various ways, such as via atube1916. Thistube1916 can be substantially flexible to facilitate movement of theapplicator tool1908 during a procedure. Thecanister1902 can have asecond tube1918 coupled thereto and connected to a gas source S so thatgas1920 can be delivered to thecanister1902. Thegas1920 can include, by way of non-limiting example, CO₂, O₂, etc. In certain aspects, the gas source S can be a continuous gas source such as a continuous CO₂gas source available in hospital operating rooms. One or more valves (not shown) can be disposed in thetube1916, in thehandle assembly1912, in theshaft1910, or in any other portion of thesystem1900 and can be selectively opened and closed by activating the actuator, such as by pivoting theactuator1914 on thehandle assembly1912. For example, one valve can control influx of thegas1920 into thecanister1902 and another valve can control delivery of thesealant1500 into theapplicator tool1908. After tissue T is stapled, such as by deploying one or more cartridges of staples onto lung tissue, thedistal end1910dof theshaft1910 of theapplicator1908 can be positioned near thestaples1008 as inFIG. 36B. Preferably, thedistal end1910dof theapplicator tool1908 is positioned about 5 to 30 mm away from a staple line depending on the size of the region to cover. A user can grasp thehandle assembly1912 of theapplicator tool1008 and activate theactuator1914, such as by moving thepivotable lever1914 proximally. This can open a valve disposed in thesystem1900 and begin delivering thegas1920 to thecanister1902 to nebulize thesealant1500 so that it forms encapsulated liquid droplets that can be sprayed directly onto the tissue T, as shown. In this way, thesealant1500 can be delivered onto the tissue along the staple line, as shown inFIG. 36C. Thesealant1500 can harden thereon, forminghardened regions1500hfacilitating formation and maintenance of a seal along thestaples1008. Thesealant1500 can also be delivered onto an adjunct rather than directly onto the tissue T, such as any of the adjuncts described herein. As will be appreciated by a person skilled in the art, sealant can be delivered to any portion of the tissue, such as only the tissue at the staple line and/or beyond the staple line.

A sealant can be delivered in various ways. For example, asystem1900′ for delivering asealant1500 is provided inFIG. 37A and includes many of the features ofFIG. 36A, including a gas source, canister, etc. However, in this embodiment the system delivers anebulized sealant1500 directly through thetrocar1200 and does not include an applicator tool. In this embodiment, the system also need not include valves and the delivery of thegas1920 to thecanister1902 can simply be controlled using a valve at the gas source. The delivery of gas into thecanister1902 can also nebulize thesealant1500, but rather than form encapsulated liquid droplets, thegas1920 can be delivered at a higher pressure and rate to create a nebulized fog of sealant1600. As shown inFIG. 37B, thissealant fog1500 can spread throughout the chest cavity of the patient and can harden on all surfaces of the tissue, such as forminghardened regions1500halong all surfaces of the patient's lungs.

In an embodiment in which the sealant is blood, such as autologous blood, the blood can be harvested from the patient and applied to the adjunct material. By way of non-limiting example, the adjunct material can be ORC, a known hemostatic agent, and the application of the blood to the ORC adjunct will cause the formation of a clot, resulting in an effective sealing structure. A person skilled in the art will appreciate that blood, such as autologous blood can be applied to a variety of adjunct materials to provide an enhanced sealing structure. Further, a person skilled in the art will appreciate that the volume of blood applied to the adjunct will vary depending upon a number of factors, including the type and location of tissue as well, the age and condition of the patient, and the identity of the adjunct. Generally, however, when the adjunct is an ORC material, the blood can be applied in an amount in the range of about 5-10 cc per line of staple used to affix the adjunct to the tissue.

Reprocessing

The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

In some embodiments, devices described herein can be processed before surgery. First, a new or used instrument, which can include an adjunct material, is obtained and if necessary cleaned. The instrument can then be sterilized. In some embodiments, the instrument can be dried, e.g., in an oven, together with a dessicant item, which can have a greater affinity for moisture than the adjunct material. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag or a 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 can then be packaged in a second container, e.g., a foil bag, which can be left open. The first and second containers, together with the instrument, can undergo ethylene oxide sterilization. The second container can then be sealed to prevent moisture exposure. Prior to sealing, a dessicant item may be included in at least one of the first and second containers to further prevent changes to one or more device components. In both techniques, the sterilized materials can then be stored in the sterile container(s) to keep the materials sterile until the container(s) is/are opened in the medical facility.

One 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 publications and references cited herein are expressly incorporated herein by reference in their entirety.