JP6556760B2 - Device for sealing staples in tissue - Google Patents

Description

  The subject matter disclosed herein relates to a method and apparatus for strengthening staple lines.

  Surgical staplers can seal, divide, and / or seal tissue in the body by closing the opening of tissue, blood vessels, conduits, shunts, or other objects or body parts involved in a particular procedure during a surgical procedure. Used for cutting. Openings may occur naturally as passages in blood vessels, airways, or lumens, or internal organs such as the stomach, or by forming a bypass or anastomosis with tissue or vascular puncture, or stapling It may be formed by the surgeon during the surgical procedure, such as by a tissue incision during the procedure.

  Most staplers have a handle with an elongated, flexible or rigid shaft that has a pair of opposing jaws at its ends formed to hold and mold the staples therebetween. At least one of the opposing jaws is movable relative to the other jaw. In laparoscopic surgery, one jaw is often fixed and the other is movable. In some devices (e.g., open linear staplers), the opposing jaws can be separated and re-accessed by the operator to provide the relative motion necessary for tissue placement. Staples are typically stored in staple cartridges, which can accommodate multiple rows of staples and are arranged in one of the two jaws for release of the staples to the surgical site. Often done. In use, the jaws are positioned so that the object to be stapled is between the jaws, and when the jaws are closed and the device is activated, the staples are released and shaped. Some staplers include a knife configured to move between the staple rows in the staple cartridge and longitudinally dissect the stapled tissue between the stapled rows. Other arrangements of the device, such as device placement, device components or system operation, and articulation, firing, etc. can be accomplished in various ways, such as electromechanical, mechanical, or hydraulic.

  Although surgical staplers have been improved over the years, many problems can arise. In rare cases, as shown in FIG. 1, one problem is that when the staple S penetrates the tissue T or other object in which the staple S is placed, the staple S leaks to form a tear. Can occur. Blood, air, gastrointestinal fluid, and other bodily fluids may ooze through the tear H formed by the staple S, even after the staple S is completely formed. The treated tissue T may become inflamed due to manipulations and deformations that may occur during stapling. Further, staples and other objects and materials that are implanted during a stapling procedure generally lack the same properties as the tissue in which they are implanted. For example, staples and other countermeasures and materials may lack the natural flexibility of the tissue in which they are implanted. One skilled in the art will recognize that it is often desirable for a tissue to maintain its natural properties as much as possible after the staples are placed therein.

  Accordingly, there remains a need for a method and apparatus for strengthening staple lines.

A staple cartridge for use with a surgical stapler is provided, which may include a cartridge body and an auxiliary material. The cartridge body may have a plurality of staple cavities configured to place staples therein. The auxiliary material can be configured to mate with the cartridge body and be removed from the cartridge body when the staples are deployed from the cartridge body into the tissue. The auxiliary material extends beyond the lateral boundary of the cartridge body in a direction transverse to the longitudinal axis of the cartridge body and a solid central portion sized and shaped to approximately match the cartridge body. A wing portion extending along at least two sides of the solid central portion.

The solid central part of the auxiliary material can be changed in any number of ways. For example, the solid central portion of the auxiliary material may be substantially rectangular. In certain aspects, the solid central portion may include first and second opposing edges. In other aspects, the wing portions may extend along first and second opposing edges of the auxiliary material. In use, the solid central portion can be configured to reinforce the seal around the staples as the adjunct and staples join the tissue.

  The wing portion can have various mechanisms. For example, the wing portion may comprise round corners. In another example, the wing portion may have a mesh structure. In certain aspects, the wing portion may have a plurality of openings formed therein. In use, the wing portion can be configured to disperse or otherwise change the strain or deformation present in the tissue outside the staple line when the auxiliary material is placed over the tissue.

The solid and wing portions can be formed from a variety of materials. In certain embodiments, the solid portion and the wing portion may be formed from a single polymer. In certain embodiments, the solid portion and the wing portion may be formed from more than one material or more than one type of material. In certain embodiments, the solid portion and the wing portion may be formed from different materials. In other embodiments, the wing portion may be more flexible as compared to the solid central portion of the auxiliary material.

  An end effector for a surgical instrument is provided, which may include first and second jaws, the first jaw having a cartridge body removably attached thereto, the cartridge body having an internal Having a plurality of staple cavities configured to place staples therein. The second jaw may include an anvil having a plurality of staple forming openings formed therein, wherein at least one of the first and second jaws is movable relative to the other jaw. The end effector can include a buttress having a width greater than the width of at least one of the cartridge body and the anvil, the buttress having a compressible central region configured to seal around the staples, and a compression A strain relief region adjacent to the sex region. The strain relief region may have a plurality of openings formed therein, and the strain relief region may 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 when the staple is deployed from the cartridge body into the compressible region of the buttress, the cartridge body and the anvil. Can be configured to be released from at least one of them.

  The end effector can be changed in many ways. In certain aspects, the plurality of openings includes slits. When the buttress and staple are deployed in the tissue, the plurality of slits may extend parallel to the longitudinal axis of the staple. In other aspects, the plurality of openings may allow the strain relief region to be more flexible along the side portions of the plurality of openings than a portion of the strain relief region adjacent to the compressible region. Are spaced apart. In other aspects, the plurality of openings are shaped such that the strain relief region is more flexible along its longitudinal portion than a portion of the strain relief region adjacent to the compressible region. And spaced apart.

  A method is provided for implanting tissue reinforcing material onto tissue, the method comprising engaging tissue between a cartridge assembly and an anvil of a surgical stapler at a surgical site, wherein at least one of the cartridge assembly and the anvil One has a tissue reinforcing material held releasably thereon. The tissue reinforcing material may include a compressible central region configured to seal around the staples and a flexible support region that defines a margin of tissue reinforcing material adjacent to the central region. By actuating the surgical stapler, staples can be ejected from the cartridge assembly to form a staple line through the central region into the tissue to hold the tissue reinforcing material at the surgical site.

  This method can be varied in any number of ways. For example, actuating the surgical stapler can fire staples through the central region, but does not fire staples through the flexible support region of tissue reinforcing material. In certain aspects, the flexible support region can be wrapped around at least one of the cartridge assembly and anvil and the cartridge assembly and anvil can be inserted into the surgical site. Actuating the surgical stapler can advance the cutting member through the tissue reinforcing material, releasing the tissue reinforcing material from the surgical stapler. In certain embodiments, the surgical stapler is actuated to advance the cutting member through the central region of the tissue reinforcing material.

The present invention will become more fully understood when the following detailed description is considered in conjunction with the accompanying drawings.
FIG. 6 is a side view of damaged, stapled tissue. FIG. 3 is a perspective view of one embodiment of an adjunct secured to stapled tissue as described herein. 1 is a perspective view of a prior art surgical instrument that can be used with one or more auxiliary materials. FIG. FIG. 4 is an exploded perspective view of the end effector and the distal end of the shaft of the instrument of FIG. 3. FIG. 4 is a perspective view of an E-beam component of the instrument of FIG. FIG. 3 is a perspective view of another prior art surgical instrument that can be used with one or more auxiliary materials. FIG. 3 is a perspective view of another prior art surgical instrument that can be used with one or more auxiliary materials. It is a perspective view of the end effector of FIG. 1 is a side view of a prior art end effector having an implantable staple cartridge therein. FIG. 1 is a side view of a prior art staple. FIG. FIG. 10 is a cross-sectional view of the end effector of FIG. 9. FIG. 8 is a plan view of a prior art staple cartridge for use with the instrument of FIG. 1 is a diagrammatic representation of a staple line attached using a prior art surgical stapling instrument. 1 is a plan view of a prior art staple cartridge having a staple pattern. FIG. It is a side view of an end effector provided with the staple cartridge carrying an auxiliary material. FIG. 5 is a side cross-sectional view of the end effector of FIG. 4 having an auxiliary material thereon. FIG. 3 is a perspective view of an auxiliary material having a central portion and a wing portion, wherein the auxiliary material is coupled to the cartridge assembly. FIG. 6 is a perspective view of an auxiliary material stapled to tissue. FIG. 10 is a perspective view of another exemplary embodiment of an auxiliary material stapled to tissue. FIG. 6 is a perspective view of an auxiliary material having a marginal protrusion configured to distribute strain to tissue outside the staple line. FIG. 10 is a perspective view of another adjunct having a marginal protrusion, wherein the adjunct is stapled to the tissue. It is a perspective view of the auxiliary | assistant material containing the outer area | region which has the some notch formed in the inside. FIG. 6 is a side view of an auxiliary material having a modified outer region. FIG. 6 is a side view of an auxiliary material having a modified outer region. FIG. 6 is a side view of an auxiliary material having a modified outer region. FIG. 3 is a side cross-sectional view of an auxiliary material stapled to a body cavity. It is a perspective view of the auxiliary | assistant material which has a 1st layer and a 2nd layer, and a textile-made atraumatic edge part. FIG. 22B is a side view of the auxiliary material of FIG. 22A showing the first layer and the second layer. FIG. 22B is a side view of the auxiliary material of FIG. 22A that absorbs fluid between the first layer and the second layer. It is a perspective view of the auxiliary | assistant material which has the thickness which fluctuates to a side surface direction. FIG. 2 is an end view of an anvil and cartridge assembly and two auxiliary portions of varying thickness, with a first auxiliary material associated with the anvil and a second auxiliary material associated with the cartridge assembly. FIG. 24 is an end view of the anvil and cartridge assembly of FIG. 23B with the first auxiliary material and the second auxiliary material combined. FIG. 6 is a side view of a first auxiliary material and a second auxiliary material stapled to tissue. FIG. 4 is a side view of an auxiliary material having a surface feature formed thereon for penetrating and gripping tissue. FIG. 6 is a side view of another auxiliary material having a surface mechanism for penetrating and gripping tissue. FIG. 4 is an end view of four rows of auxiliary materials, each row of auxiliary materials having a surface feature fixed in the tissue. It is a side view of the auxiliary material which has the surface mechanism which penetrated the structure | tissue. FIG. 6 is a side view of another exemplary aid having a plurality of pointed surface features for penetrating tissue. FIG. 24B is a side view of the supplement of FIG. 24A having a pointed surface feature that penetrates tissue. FIG. 3 is a perspective view of a cartridge assembly having an auxiliary material for releasably coupling to a distal end of the cartridge assembly. FIG. 26B is a side view of a cartridge assembly and anvil of a surgical stapler grasping tissue, with the aid of FIG. 26A extending beyond the distal end of the cartridge assembly. FIG. 26B is a side view of the cartridge assembly and anvil of FIG. 26B deploying staples through the backing and tissue. FIG. 5 is a perspective view of an auxiliary material having a protrusion configured to mate with a corresponding recess formed in the cartridge assembly. FIG. 5 is a perspective view of an auxiliary material having a single protrusion configured to mate with a corresponding recess formed in the cartridge assembly. FIG. 6 is an end view of an auxiliary material extending around a cartridge assembly having a first side edge and a second side edge coupled to the cartridge assembly. FIG. 27B is an end view of the auxiliary material and cartridge assembly of FIG. 27A, wherein a cutting member is advanced through the cartridge assembly to release the auxiliary material from the cartridge assembly. FIG. 3 is a perspective view of a cartridge assembly including a suture connecting an auxiliary material and the cartridge assembly. FIG. 29B is a perspective view of the cartridge assembly and auxiliary material of FIG. 29A with the suture removed from the cartridge assembly to release the auxiliary material. FIG. 5 is a perspective view of a shaft of a surgical stapler to which an auxiliary material is coupled. FIG. 30B is a side view of the shaft of FIG. 30A showing attachment points for attaching the auxiliary material to the shaft. FIG. 5 is a perspective view of a driver that can be inserted into a shaft and has a plurality of lateral extensions. It is a perspective view of the auxiliary material for attaching a shaft. FIG. 30B is a partial plan view of the shaft of FIG. 30A with the stapler cutting member in a first retracted position; FIG. 30B is a partial plan view of the shaft of FIG. 30A with a cutting member in a second advanced position that releases the auxiliary material from the shaft. 1 is an end view of a cartridge assembly, an auxiliary material, and an insertion tool for attaching the auxiliary material to the cartridge assembly. FIG. FIG. 31B is an end view of the insertion tool pressing the aid against the cartridge assembly of FIG. 31A. FIG. 31B is an end view of the cartridge assembly of FIG. 31A after the auxiliary material has been installed and the insertion tool has been removed from the cartridge assembly. FIG. 2 is an exemplary kit including a retention tool and a surgical stapler, wherein the retention tool is configured to wrap the auxiliary material around the cartridge assembly / anvil. FIG. 32B is a side view of the retention tool of FIG. 32A, advanced proximally along the longitudinal axis of the anvil and cartridge assembly. FIG. 32B is a perspective view of the holding tool and stapler of FIG. 32A, where the holding tool is in a proximal position. FIG. 6 is a perspective view of the end effector of the stapler with the auxiliary material coupled and positioned above the trocar. FIG. 33B is a perspective view of the end effector of FIG. 33A with an auxiliary material that is wrapped around the end effector when the end effector is inserted into the trocar. 1 is an end view of a cartridge assembly and anvil of a surgical stapler with multi-layered adjuncts attached thereto. FIG. FIG. 6 is a side view of three auxiliary sections stapled to tissue and having a polymerized portion therebetween. FIG. 6 is a perspective view of a first auxiliary material and a second auxiliary material that are stapled in tissue and have a first and a second polymerized portion. FIG. 3 is a perspective view of a first auxiliary material and a second auxiliary material having a sealant stapled to tissue and delivered to the outer surface of the first auxiliary portion. FIG. 35B is a side view of the first auxiliary material and the second auxiliary material of FIG. 35A stapled to tissue. FIG. 35B is a side view of the first auxiliary material and the second auxiliary material of FIG. 35A with sealant delivered to a space below the outer surface of the auxiliary material. FIG. 35B is a side view of the first auxiliary material and the second auxiliary material of FIG. 35A in the expanded posture. 1 is a perspective view of a system for atomizing a sealant including a container and an applicator tool that extends into a patient via a trocar. FIG. FIG. 36B is a perspective view of the applicator tool of FIG. 36A delivering sealant to the staple line of tissue. FIG. 36B is a perspective view of the atomized sealant of FIG. 36A cured on staple lines. FIG. 5 is a perspective view of another exemplary system for atomizing sealant and delivering the atomized sealant to a patient directly via a trocar into the patient. FIG. 37B is a perspective view of the trocar of FIG. 37A delivering atomized sealant to tissue on the staple line and to tissue outside the staple line.

  Certain exemplary embodiments will now be described to provide a comprehensive understanding of the structure, function, manufacture, and use of the devices disclosed herein and the principles of the method. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will appreciate that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and the scope of such devices and methods is: It will be understood that this is only defined by the claims. The features illustrated or described in the context of 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 this disclosure, components of the same reference number in various embodiments generally have the same characteristics if they serve the same nature and / or the same purpose.

  Throughout this specification, references to “various embodiments,” “some embodiments,” “one embodiment,” or “embodiments,” and the like are specific for the particular embodiment described in connection with that embodiment. A feature, structure, or characteristic is meant to be included in at least one embodiment. Thus, throughout the specification, phrases such as “in various embodiments”, “in some embodiments”, “in one embodiment”, or “in an embodiment” appear. These are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, a particular feature, structure, or characteristic illustrated or described in connection with one embodiment may be combined, in whole or in part, with the feature, structure, or characteristic of one or more other embodiments. Can be combined without any restrictions. Such modifications and variations are intended to be included within the scope of the methods, instruments, devices, and systems described herein.

  The terms “proximal” and “distal” are used herein with reference to a clinician maneuvering the handle portion of the surgical instrument. The term “proximal” refers to the portion closest to the clinician, and the term “distal” refers to the portion that is remote from the clinician. It will be further understood that for convenience and clarity, spatial terms such as “vertical”, “horizontal”, “top”, and “bottom” may be used herein with respect to the drawings. Let's go. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.

  It may be desirable to use one or more biomaterials and / or synthetic materials, collectively referred to herein as “adjuncts”, in conjunction with a surgical instrument to help improve surgical procedures. possible. These biomaterials may be derived from human and / or animal sources. Those skilled in the art may refer to these types of materials as auxiliary materials or reinforcements.

  Various exemplary devices and methods for performing a surgical procedure are provided. In some embodiments, devices and methods for open surgical procedures are provided, and in other embodiments, devices for laparoscopic, endoscopic, and other minimally invasive surgical procedures and A method is provided. These devices may be remotely fired directly by a human user or under direct control of a robot or similar operating tool. However, one of ordinary skill in the art will appreciate that the various methods and devices disclosed herein can be used in numerous surgical procedures and applications. Various instruments disclosed herein may be inserted into the body in any way, such as through a natural opening, through an incision or puncture hole formed in tissue, or using an access device such as a trocar cannula. One skilled in the art will further recognize that this can be done. For example, the working or end effector portions of these instruments can be inserted directly into the patient's body or access devices having working channels that can advance the end effector and elongated shaft of the surgical instrument. Can be inserted.

  As described herein, an end effector of a surgical instrument delivers one or more synthetic and / or biomaterials collectively referred to herein as “adjuncts” to a surgical site. And can be configured to assist in improving the surgical procedure. These biomaterials may be derived from human and / or animal sources. A variety of different end effectors may benefit from the use of ancillary materials, and in some exemplary embodiments, the end effector may be a surgical stapler. When used with a surgical stapler, the auxiliary material may be disposed between and / or above the stapler jaws, incorporated into a staple cartridge disposed on the jaws, or otherwise stapled. It may be placed proximally. Once the staples are deployed, the auxiliary material may remain with the staples in the treatment section, which can provide many benefits. In some cases, adjuncts can be used to assist in sealing holes formed by staples when they are implanted in tissue, blood vessels, and various other objects and body parts, and / Or can be used to provide tissue augmentation at the treatment site. Tissue augmentation prevents the staples from tearing tissue when it is healed from another condition such as radiation therapy, drug therapy such as chemotherapy, or other conditions that alter tissue properties if the tissue is lesioned There are things you need to do. In some cases, the adjunct may minimize tissue movement in and near the staple puncture site that may result from tissue deformation (eg, pulmonary dilation, gastrointestinal dilation, etc.) that occurs after stapling. One skilled in the art will recognize that the staple puncture site can be a stress concentration site and that the size of the hole formed by the staple increases when the nearby tissue is placed under tension. Limiting tissue movement near these puncture sites can minimize the size of the pores that can increase under tension. In some cases, the adjunct may be configured to wick or absorb beneficial fluids that further promote healing, such as, for example, sealants, blood, adhesives, and the like. Also, in some cases, the adjuvant can be configured to decompose to form a gel that further promotes healing, such as, for example, a sealant. In some cases, the supplement may include a material that forms a sealant that forms a seal when placed in a humid environment (eg, blood, water, saline, or other bodily fluid) ( For example, human or animal fibrinogen and thrombin can be lyophilized to a powder that provides a sealant when mixed with water). Still further, adjuncts can help reduce inflammation, promote cell growth, or otherwise improve healing.

  FIG. 2 illustrates one embodiment of an auxiliary material that includes a perforated buttress 30 that can be secured to tissue T to be treated by a surgical stapler and remains with staples 70 at the treatment site. Buttress 30 may be made of one or more absorbent materials, stamped and squeezed to facilitate the absorption, strengthening, delivery, and / or retention of beneficial fluids such as sealants, adhesives, and blood. , Cutting, molding, weaving, melting, blowing, composite structures and / or methods, or other methods. Absorbing and / or retaining a beneficial fluid, such as fibrin sealant 40, at the treatment site may further help prevent leakage and strengthen buttress 30.

Surgical Stapling Instruments Although various surgical instruments may be used with the aids disclosed herein, FIG. 3 illustrates a surgical stapler 10 suitable for use with one or more aids. 1 illustrates one non-limiting exemplary embodiment. The instrument 10 generally includes a handle assembly 12, a shaft 14 extending distally from the distal end 12d of the handle assembly 12, and an end effector 50 at the distal end 14d of the shaft 14. Since the illustrated embodiment is a surgical stapler, the end effector 50 has jaws 52, 54, but other types of end effectors are used with the shaft 14, handle assembly 12, and associated components. obtain. Surgical stapler 10 includes opposing lower and upper jaws 52, 54, which includes a staple channel 56 (FIG. 4) configured to support staple cartridge 60, wherein upper jaw 54 includes Opposite the lower jaw 52 and has an inner surface 58 configured to act as an anvil to assist in the deployment of the staples 70 of the staple cartridge 60. The jaws 52, 54 are configured to move relative to each other to clamp tissue or other objects disposed therebetween, and the components of the firing system include at least a portion of the end effector 50. It can be configured to pass through and release the staples into the clamped tissue. In various embodiments, the knife blade 81 can be connected to a firing system and can incise tissue during a stapling procedure. At least one of the opposed lower and upper jaws 52, 54 is movable relative to the other lower and upper jaws 52, 54. At least one of the opposing lower and upper jaws 52, 54 may be fixed or otherwise immovable. In some embodiments, both the opposing lower and upper jaws 52, 54 are movable.

  Activation of the end effector 50 can be initiated by input from the clinician at the handle assembly 12. The handle assembly 12 may have many different configurations designed to handle and manipulate the end effector 50 coupled thereto. In the illustrated embodiment, the handle assembly 12 has a pistol-type housing 18 with various mechanical and / or electrical components disposed therein to operate various functions of the instrument. For example, the handle assembly 12 is mounted adjacent its distal end 12d that may facilitate rotation of the shaft 14 and / or end effector 50 about the longitudinal axis L of the shaft 14 relative to the handle assembly 12. Rotation knob 26 may be included. The handle assembly 12 may further include a clamping component as part of the clamping system actuated by the clamp trigger 22 and a firing component as part of the firing system actuated by the firing trigger 24. The clamps and firing triggers 22, 24 can be biased to the open position relative to the stationary handle 20, for example by a torsion spring. Movement of the clamp trigger 22 toward the stationary handle 20 can actuate the clamping system described below, thereby causing the jaws 52, 54 to tilt toward each other, thereby clamping the tissue therebetween. Movement of firing trigger 24 may activate the firing system described below, thereby releasing staples from a staple cartridge disposed therein and / or advancing knife blade 81 to cause jaws 52, Tissue captured during 54 may be cut. Those skilled in the art will recognize various configurations of mechanical, hydraulic, pneumatic, electromechanical, robotic, or other firing system components that can be used for staple ejection and / or tissue dissection, and therefore Detailed description is not necessary.

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

  Various clamping components can be used to provide opening and closing of the jaws 52, 54 to selectively clamp tissue between them. In the illustrated embodiment, the pivot end 54 p of the upper jaw 54 includes a closure mechanism 54 c distal to the pivot attachment with the staple channel 56. Accordingly, the closure tube 82, which includes a horseshoe-shaped opening 82a whose distal end engages the closure mechanism 54c, is responsive to the clamp trigger 22 relative to the upper jaw 54 during proximal longitudinal movement of the closure tube 82. The opening movement is selectively applied to the upper jaw 54 during the distal longitudinal movement of the closing tube 82. One skilled in the art can open and close the end effector 50 by relative movement of the lower jaw 52 relative to the upper jaw 54, relative movement of the upper jaw 54 relative to the lower jaw 52, or movement of both jaws 52, 54 relative to each other. You will understand that.

  The firing component of the illustrated embodiment may include a firing bar 84 having an E-beam 86 at the distal end, as shown in FIG. The firing bar 84 is contained within the shaft 14, eg, within the longitudinal firing bar slot 14 of the shaft 14, and is induced by a firing motion from the handle 12. Actuation of the firing trigger 24 can affect the distal movement of the E-beam 86 through at least a portion of the end effector 50, thereby firing the staple 70 contained within the staple cartridge 60. In the illustrated embodiment, the guide 85 protruding from the distal end of the E-beam 86 can engage the wedge thread 90, which in turn passes through the staple cavity 68 formed in the staple cartridge 60. The staple driver 92 can be pushed up through. The upward movement of the staple driver 92 applies an upward force to each of the plurality of staples 70 in the cartridge 60, thereby pushing the staple 70 against the anvil surface 58 of the upper jaw 54 and lifting the formed staple 70 ′. Form.

  E-beam 86 facilitates closing of jaws 52, 54, pulling upper jaw 54 away from staple cartridge 60, and / or cutting tissue captured between jaws 52, 54 in addition to firing staples. Can be configured as follows. Specifically, a pair of top pins 87 and a pair of bottom pins 89 engage one or both of the upper and lower jaws 52, 54 so that the jaws as the firing bar 84 advances through the end effector 50. 52, 54 may be pressed toward each other. At the same time, the knife 81 extending between the top pin 87 and the bottom pin 89 can be configured to cut tissue captured between the jaws 52, 54.

  In use, surgical stapler 10 can be placed within a cannula or port and placed at the surgical site. The tissue to be incised and stapled may be placed between the jaws 52, 54 of the surgical stapler 10. The mechanism of the stapler 10 can be manipulated as desired by the clinician to achieve the desired position of the jaws 52, 54 at the surgical site and tissue for the jaws 52, 54. After achieving proper positioning, the clamp trigger 22 can be pulled toward the stationary handle 20 to activate the clamp system. The trigger 22 causes the closure tube 82 to travel distally through at least a portion of the shaft 14 to tilt at least one of the jaws 52, 54 toward the other and clamp tissue disposed therebetween. As such, the components of the clamping system may be actuated. Thereafter, firing bar 84 and / or E-beam 86 travels distally through at least a portion of end effector 50 to effect firing of staples 70 and optionally capture between jaws 52, 54. The trigger 24 may be pulled towards the stationary handle 20 to activate the components of the firing system so as to cut the tissue that has been cut.

  Another embodiment of the surgical instrument 100 is shown in FIG. Like surgical instrument 10, surgical instrument 100 includes a handle assembly 112 that includes a distally extending shaft 114 having an end effector 150 at a distal end for treating tissue. The upper and lower jaws 154, 152 of the end effector 150 capture tissue between them, staple the tissue by firing staples from the cartridge 160 disposed in the lower jaw 154, and / or incise the tissue. May be configured to form a portion. In this embodiment, the attachment 116 at the proximal end of the shaft 114 may be configured to allow the shaft 114 and the end effector 150 to be removably attached to the handle assembly 112. Specifically, the fitting mechanism 125 of the attachment portion 116 can be fitted with the auxiliary fitting mechanism 123 of the handle assembly 112. Although any number of auxiliary mating mechanisms and any type of coupling may be used to removably couple the shaft 114 to the handle assembly 112, the mating mechanisms 123, 125 may be, for example, snap-fit couplings, bayonet couplings And so on. Although the entire shaft 114 of the illustrated embodiment may be configured to be detachable from the handle assembly 112, in some embodiments, the attachment 116 is configured such that only the distal portion of the shaft 114 can be removed. Can be done. Removable coupling of shaft 114 and / or end effector 150 allows for selective attachment of desired end effector 150 for a particular procedure and / or reuse of handle assembly 112 for a number of different procedures. Can be.

  The handle assembly 112 has one or more mechanisms thereon to handle and manipulate the end effector 150. As a non-limiting example, a rotation knob 126 attached to the distal end of the handle assembly 112 can facilitate rotation of the shaft 114 and / or end effector 150 relative to the handle assembly 112. Handle assembly 112 may further include a clamping component as part of a clamping system actuated by trigger 122 and a firing component as part of a firing system that may also be actuated by trigger 122. Accordingly, in some embodiments, movement of the trigger 122 toward the stationary handle 120 through the first range of motion actuates the clamping components to bring the opposing jaws 152, 154 toward each other and approach the closed position. Can be. Further movement of the trigger 122 toward the stationary handle 120 through the second range of motion can actuate the firing component to release the staples from the staple cartridge 160 and / or advance the knife to move the jaws 152. , Tissue captured between 154 may be cut.

  Yet another embodiment of a surgical instrument 200 is shown in FIG. Like surgical instruments 10 and 100, surgical instrument 200 includes a handle assembly 212 that includes a distally extending shaft 214 having an end effector 250 at the distal end for treating tissue. The end effector 250 may include a cartridge assembly 252 and an anvil 254, each having a substantially circular shaped tissue contacting surface 260p, 260d. The cartridge assembly 252 and the anvil 254 may be coupled to the handle assembly 212 of the stapler 200 by a shaft 262 extending from the anvil 254, and operating the actuator 222 on the handle assembly 220 causes the shaft 262 to advance and retract relative to the cartridge assembly 252. The anvil 254 can be moved. In one embodiment, the shaft 262 is releasably coupled to one another so that the anvil 254 can be removed from the cartridge assembly 252 to allow for a more flexible positioning of the anvil 254 and the cartridge assembly 252 within the body. The first portion and the second portion (not shown) are formed. For example, the first portion of the shaft may be disposed within the cartridge assembly 252 and extend distally outside the cartridge assembly 252 and terminate in a distal mating mechanism. A second portion of the shaft 214 may be disposed within the anvil 254 and may extend proximally outside the cartridge assembly 252 and terminate within the proximal mating mechanism. In use, the proximal and distal mating mechanisms may be coupled to allow the anvil 254 and cartridge assembly 252 to move relative to each other. Anvil 254 and cartridge assembly 252 can perform various functions, and can be configured to staple tissue between them by capturing tissue and firing staples from cartridge assembly 252 and / or incising tissue. Part can be formed. In general, the cartridge assembly 252 can house a cartridge containing staples and can be pressed against the anvil 254 to deploy the staples to form a circular pattern of staples around the tubular body organ.

  The handle assembly 212 of the stapler 200 can have various actuators disposed thereon that can control the movement of the stapler. For example, the handle assembly 212 may have a rotation knob 226 disposed thereon to facilitate positioning of the end effector 250 by rotation and / or a trigger 222 that activates the end effector 250. Movement of the trigger 222 through the first range of motion may activate the components of the clamping system to approximate the jaws. That is, the anvil 254 can be moved toward the cartridge assembly 252. Movement of the trigger 222 through the second range of motion may actuate the firing system components to deploy staples from the staple cartridge assembly 252 and / or advance the knife so that the cartridge assembly 252 and anvil. Tissue captured between 254 can be cut.

  The illustrated embodiments of surgical stapling instruments 10, 100, and 200 provide only a few examples of the many different configurations and associated methods of use, which are provided herein. Can be used with the disclosure. The illustrated embodiments are all configured for use in minimally invasive procedures, but are described in instruments configured for use in open surgical procedures, such as US Pat. No. 8,317,070. It will be appreciated that open linear staplers can be used with the disclosure provided herein. Additional details regarding the illustrated embodiments, as well as additional exemplary embodiments of a surgical stapler that can be used in accordance with the present disclosure, its components, and methods of use associated therewith, include US 2013/0256377, U.S. Patent Nos. 8,393,514, 8,317,070, 7,143,925, U.S. Patent Application No. 14 / 074,884 (named "Sealing Materials for Use in Surgical Procedures", No. 14 / 074,810 (named “Hybrid Adjunct Materials for Use in Surgical Stapling”, filed Nov. 8, 2013), No. 14 / 075,438, filed on Nov. 8, 2013. “Pos ”lively charged IMPLANT MATERIALS AND METHOD OF FORMING THE SAME”, filed on Nov. 8, 2013, No. 14 / 075,459 (named “Tissue Ingredients of the 8th month” ), No. 14 / 074,902 (named “Hybrid Adjunct Materials for Use in Surgical Stapling”, filed on Nov. 8, 2013), No. 14 / 226,142 (named “Surgical Instrument Comprising Inst. , Filed on March 26, 2014) Components, and methods and the like, each of which is incorporated in its entirety herein by reference.

End Effector Variations The end effector of the surgical stapling instrument described herein may have one or more mechanisms for adjusting the amount of compression that the end effector applies to the captured tissue. In some embodiments, the end effector has a desired compression profile (eg, a profile that helps minimize bleeding, tearing, and / or leakage of the treated tissue) in the tissue captured in the end effector. Can be configured to create. As a non-limiting example, the desired tissue compression profile uses changes in the gap between the upper and lower jaws of the end effector and / or changes in the orientation, size, and / or shape of staples applied to the tissue by the end effector. Can be obtained. As described in detail herein, the ancillary material used with such an end effector helps create a desired tissue compression profile and / or a mechanism used to create a desired tissue compression profile. It can be configured to correspond to.

  All such variations described herein can be used alone or in combination to provide the desired tissue compression profile. Although the exemplary end effector and its components are described in connection with certain surgical instruments, such as instruments 10, 100, and 200, the end effector and its components are described in the surgical instrument described herein. It should be understood that it may be configured for use in other embodiments.

  In some embodiments, the staple cartridge disposed within the end effector of the surgical stapling instrument is more responsive to comparing tissue captured by the end effector with the second portion when the end effector is in the closed position. There may be a first portion configured to squeeze. The first portion of the cartridge can be spaced longitudinally and / or laterally from the second portion to create the desired compression gradient. For example, as shown in FIGS. 4 and 8, the staple cartridge 60 may have a surface that contacts the stapled tissue. Specifically, the cartridge 60 may have an inner tissue contacting surface 62 and an outer tissue contacting surface 64 that extends upward to a height higher than the inner tissue contacting surface 62. In this way, when the upper jaw 54 is in a closed position in close proximity to the cartridge 60, the anvil surface 58 is more prone to the outer surface 64 compared to the inner surface 62 because the height of the outer surface 64 is higher. Can be configured to squeeze. In some situations, including situations where the tissue is positioned between the anvil surface 58 and the cartridge 60 and the cartridge 60 has a constant or at least substantially constant thickness, the pressure generated in the tissue may cause the end effector to The outer portion of the end effector 50 can be larger than the inner portion of the 50. Although the compression gradient generated by the cartridge 60 varies stepwise, those skilled in the art will generate progressive compression gradients in tissue by progressively increasing the height of various portions of the cartridge 60. It will be understood that this is possible. Further, the compression gradient can be caused by the height variation of the anvil surface 58 alone or by a combination of the height variation of the anvil surface 58 and the height variation of the cartridge 60, and the height variation is the end effector 50. It should also be understood that they may be laterally and / or longitudinally spaced across.

  In some embodiments, one or more aids secured to the 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 to FIG. 9, a compressible and implantable staple cartridge 360 can be formed from one or more auxiliary materials as described herein, and can include an end effector (eg, a surgical instrument) , End effector 350). The cartridge 360 may have a height that decreases from a maximum height H1 at its distal end 360d to a minimum height H2 at its proximal end 360p. In this way, when the upper jaw 354 of the end effector 350 is in a closed position in close proximity to the cartridge 360, the upper jaw 354 of the end effector 350 has more distal end 360d compared to the proximal end 360p. Can be configured to squeeze. Although the compression gradient created in the tissue captured by the cartridge 360 decreases linearly from the distal end 360d to the proximal end 360p, those skilled in the art will recognize any compression depending on the various shapes of the cartridge 360. It will be appreciated that a gradient can be created. In at least one embodiment, similar to cartridge 360, the thickness of cartridge 360 may vary across its width.

  In some embodiments, the staples housed in the end effector staple cartridge can be configured to create a desired compression profile in the tissue captured by the staples. For example, a desired compression profile can be created in the stapled tissue where the staples in the staple cartridge have different unformed staple heights. As shown in FIG. 10, the unformed height H of the exemplary staple 70 can be measured from the base 74 of the staple 70 to the upper ends or the tips of the legs 72a, 72b of the staple 70. Referring now to FIG. 11, which shows a cross-section of the end effector 350, the first staple group 370a has a higher first staple height H1 compared to the second staple height H2 of the second staple group 370b. Can have. The first staple group 370a can be positioned on a first portion (eg, the outer portion) of the staple cartridge 360, and the second staple group 370b is positioned on a second portion (eg, the inner portion) of the staple cartridge 360. be able to. In the illustrated embodiment, the cartridge 360, and thus the compression gradient, can be configured to be symmetric about a slot 367 that is configured to receive through a cutting instrument (eg, E-beam 86). For those skilled in the art, the first staple group 370a and the second staple group 370b may be arranged in an arbitrary pattern, and may be arranged laterally and / or longitudinally apart along the cartridge 360. It will be understood. In certain embodiments, multiple groups of staples may be used, each group having a different unformed staple height. In at least one such embodiment, a third group having an intermediate staple height can be positioned intermediate the first and second staple groups in the cartridge. In various embodiments, each staple in a staple row in a staple cartridge can include a different staple height. In at least one embodiment, the tallest staple in the staple row may be placed in the first end of the staple row, and the shortest staple may be placed in the opposite end of the staple row. is there. In at least one such embodiment, the staple disposed intermediate the highest staple and the shortest staple is configured, for example, such that the staple height is lowered between the highest staple and the shortest staple. Can be done.

  Similarly, the staples in the staple cartridge can have various crown widths to create the desired compression profile in the stapled tissue. As shown in FIG. 10, the crown width W of the exemplary staple 70 can be measured from one side of the base 74 of the staple 70 to the opposite side. Similar to the above variation in staple height H, variations in staple width W can be spaced apart across the staple cartridge to create a plurality of staple groups distributed longitudinally and / or laterally across the cartridge. As a non-limiting example, FIG. 12 shows a staple cartridge 260 for use with a surgical instrument 200 having staples 270 with various crown widths W therein. Staple cartridge 260 houses three groups of staples 270a, 270b, 270c, each having different widths W1, W2, and W3, although any number of staple groups is possible. As shown, the staple groups 270a, 270b, 270c can be arranged in a circumferential row, with the staple 270c having a maximum width W1 positioned at the outermost edge of the cartridge 260 and the staple 270a being in the cartridge 260. And has a minimum width W3 positioned at the innermost edge. In other embodiments, larger crown width staples can be positioned proximal to the innermost edge of the cartridge and smaller crown width staples positioned proximal to the outer edge of the cartridge. can do. In still further embodiments, staples along the same row can have various crown widths.

  Additionally or alternatively, it may be possible to create a desired tissue compression profile by creating various post-formation (final) staple heights. FIG. 13 illustrates the surgical stapling described herein configured to create a cutting line 494 by cutting tissue in addition to applying staples 470 ′ having various post-formation heights. FIG. 10 illustrates an exemplary embodiment of a line formed by staples 470 ′ attached using an instrument. As shown in FIG. 13, the post-formation height F1 of the first row of first staple groups 470a ′ located at the furthest distance from the cutting line 494 is the third height in the third row closest to the cutting line 494. This is larger than the post-formation height F3 of the staple group 470c ′. The second staple group 470b ′ in the second row formed between the first row and the third row has staples 470b ′ having a post-formation height F2 that is intermediate between the heights F1 and F3. obtain. In other embodiments, the post-staple height may decrease from the innermost row to the outermost row. In yet further embodiments, the post-form height of staples in a single row may increase or decrease between staples.

  Referring again to FIG. 11, the difference in staple height after formation can be achieved, for example, by changing the staple forming distance A. The forming distances A1, A2 can be measured from the bases of the staples 370a, 370b in the cartridge 360 when the upper jaw 354 is in the closed position, and the tips of the corresponding forming pockets 366 on the anvil surface 358, respectively. In one embodiment, for example, the first staple forming distance A1 is different from the second staple forming distance A2. Since the formation distance A1 is larger than the formation distance A2, the staple 370a is not compressed as much as the staple 370b, and thus the post-form height of the staples 370a and 370b can be changed. In particular, a greater amount of compression corresponding to a smaller forming distance may result in smaller (final) height staples after forming. It should be understood that similar results can be achieved in any desired pattern.

  Various tissue compression gradients can be obtained from the staple orientation patterns in the staple cartridge (eg, by the patterns shown in FIGS. 14 and 15). In the embodiment shown in FIG. 14, the staple cartridge 560 may include at least one first staple cavity 568a and at least one second staple cavity 568b to house the staple 570 therein. The first cavity 568 a can be located on the first side 563 of the cartridge 560 and the second cavity 568 b can be located on the second side 565 of the cartridge 560, The second side 565 is separated by a slot 567 configured to receive a cutting instrument, eg, the E-beam 86 therethrough. The first cavity 568a can define a first longitudinal axis 569a, and the second cavity 568b can define a second longitudinal axis 569b. In the illustrated embodiment, the first axis 569a is perpendicular or nearly perpendicular to the second axis 569b. In other embodiments, the first axis 569a may intersect the second axis 569b so that the axes 569a, 569b can create an acute or obtuse angle therebetween. In still other embodiments, the first axis 569a may be parallel or substantially parallel to the second axis 569b. In some embodiments, at least a portion of the staple cavities 568a, 568b may be polymerized so that the staples 570 in the staple cavities 568a, 568b can be interlocked during formation. The cartridge 560 may have a plurality of first cavities 568a and a plurality of second cavities 568b, and these cavities may be formed in an arbitrary pattern on the first side surface 563 and the second side surface 565 of the cartridge 560 (for example, the cartridge 560 along both sides 563, 565 of the 560, in a row extending along the longitudinal axis Lc of the cartridge 560. Staples 570 housed in cavities 568a, 568b can be implanted into the tissue in a pattern determined by the orientation and positioning of cavities 568a, 568b. For example, the cartridge 560 can be used to implant staples 570 having different orientations of staples 570 on either side of the incision line made by the surgical instrument carrying the cartridge 560.

  In other embodiments, such as the cartridge 660 embodiment shown in FIG. 15, both staple cavities 668 a and 668 b having different orientations may be located on a single side of the cartridge 660. As shown in FIG. 15, the axis 669a of the first staple cavity 668a is perpendicular or substantially perpendicular to the axis 669b of the second staple cavity 668b, both of which are the first of the cartridge 660. It is disposed on each of the side surface 663 and the second side surface 665. In other embodiments, the axes 669a, 669b may form an acute or obtuse angle therebetween, or may be parallel to each other. The plurality of first cavities 668a and second cavities 668b are aligned in adjacent rows along the longitudinal axis Lc ′ of the cartridge 660 on the first side 663 and the second side 665 of the cartridge 660, respectively. obtain. In this embodiment, the staples 670 housed in the cavities 668a, 668b can be implanted into the tissue in a symmetrical pattern about an incision line made by a surgical instrument having a cartridge 660. Further details of staple patterns, and further embodiments of such patterns, can be found in US Patent Application Publication No. 2011/0192982, which is incorporated herein by reference in its entirety.

Exemplary Compositions of Auxiliary Materials Regardless of the configuration of the surgical instrument, the present disclosure, in conjunction with the method of operating the instrument, includes implantable materials such as, for example, synthetic and / or biomaterials (collectively “adjuvants”) Provide the use of. As shown in FIG. 16, the end effector 50 may include at least one piece of auxiliary material 30 positioned intermediate the lower and upper jaw members 52, 54, wherein the auxiliary material 30 includes the staple channel 56 and / or the anvil surface. One of 58 may be releasably held. In use, the adjunct 30 and patient tissue may be captured by the staple 70 when the staple 70 is fired. Subsequently, the adjunct 30 can be separated from the surgical stapler and can be placed in the patient when the stapler is removed from the patient. Exemplary devices and methods for attaching one or more auxiliary materials to an end effector of a surgical instrument are described in US 2013/0256377 and the like, incorporated herein by reference in their entirety. No. 2013/0153641.

  Adjuncts used with the disclosure provided herein may have any number of configurations and characteristics. In general, the adjunct is destroyed, for example, bioabsorbable material, biodegradable material, and / or otherwise, so that the adjunct is absorbed, dissolved, degraded, and / or destroyed during the healing process. Can be made of materials that can be made. In at least one embodiment, the adjuvant can be configured to degrade over time to form a gel, eg, a sealant, to assist wound healing. In other embodiments, the adjunct may include a therapeutic agent that is, for example, released over time and may be configured to assist in the treatment of the tissue. In various further embodiments, the auxiliary material may comprise, for example, a material that is non-absorbable and / or cannot be destroyed.

  Some particularly beneficial adjuncts can include a porous polymer scaffold that can be configured to break, for example, by exposing the water to water so as to attack the polymer bonds of the material. The disassembled adjunct may be configured to gel on the wound site, thereby covering the wound tissue, eg, wound soft tissue, which may be compressed, sealed, and / or generally tissue at the wound site. Can help create an environment that promotes healing. Specifically, such degradable polymers can allow the tissue itself to become a load-bearing component. In some embodiments, the degraded adjuvant may include a chemoattractant that attracts the natural healing compound to the wound site. The polymer scaffold can be configured to have a desired degradation rate (eg, within minutes to hours after attachment to tissue), thereby assisting the healing process substantially immediately after attachment. For further details of porous polymer scaffolds as described herein, see Q.C., which is incorporated herein by reference in its entirety. Chen et al. , Elastomeric biomaterials for tissue engineering, Progress in Polymer Science 38 (2013) 584-671.

  In some embodiments, the porous polymer scaffolds described herein can be physically cross-linked, which allows the polymer to have any desired porosity, surface area to volume ratio, and mechanical properties. It can be formed into various complex three-dimensional shapes, such as fibers, sheets, films, and the like. The scaffold can be formed into the desired shape by a number of methods, such as by extrusion, wet spinning, electrospinning, thermally induced phase separation (TIPS), salt leaching / freeze drying, and the like. When forming the scaffold into a film or sheet, the film or sheet has any desired thickness, for example, in the range of about 50-750 μm or in the range of about 1-3 mm, depending on the desired application. obtain.

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

  Each of the three layers can be configured to degrade separately and have different healing effects, but the three-layer film degrades almost immediately after attachment to the tissue, for example, within about 1-2 hours after attachment. Can be configured to. The order, number, and thickness of each layer can vary and can be adjusted to provide the desired degradation and / or compression ratio. In some embodiments, the first, second, and third layers are formed on a matrix, ie, a substrate, eg, on a PCL, that can be configured to assist in mechanical compression of the wound tissue. Can be done.

  Another exemplary embodiment of a porous polymer scaffold can be synthesized from polyhydroxyalkanoate (PHA). In an exemplary embodiment, PHA can be produced naturally from a variety of microorganisms, such as Gram negative or Gram positive bacteria, for example, with the production of Biopol® available from Zeneca (London, United Kingdom). It can be synthesized as well. Because PHA dissolves very quickly, scaffolds made with PHA can begin to degrade within 20-30 minutes after attachment to tissue by contact with heat and / or water. If the PHA scaffold has a higher molecular weight, the degradation time can be longer, for example in the 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, for example in the range of 50-750 μm. In some embodiments, the PHA can be copolymerized and / or blended with one or more additional materials. By way of non-limiting example, PHA can reduce the concentration, crystallinity, and / or brittleness of PHA, which can reduce hydroxlvalerate (HV), hydroxybutyrate (HB), and / or hydroxy. It can be copolymerized with hydroxylhexanoate (HH). In other embodiments, the PHA may be blended with one or more thermoplastics, such as poly (lactic acid) (PLA), PGA, PCL, starch, etc., thereby reducing the molecular weight and result of the scaffold Customize the mechanical properties obtained as In certain embodiments, one or more of the polymers can be a thermoplastic polymer.

  In other embodiments, the scaffold can be synthesized from poly (polyol sebacic acid) (PPS), such as from poly (glycerol sebacic acid) (PGS). Such scaffolds can be biocompatible, among others, and can provide the additional benefit of reducing the risk of infection in addition to promoting healing. Other exemplary embodiments can be synthesized from xylitol-based elastomers, such as polyxylitol sebacic acid (PXS), which can provide structural stability over the clinically required period and / or blood glucose level Can gradually enter metabolic pathways without rapidly changing. Scaffolds made from PXS can be formed into a thicker film, which can result in stronger compression at the wound site and can be configured to degrade within a range of about 10 hours to 8 days after attachment. Yet another exemplary embodiment is poly (glycerol sebacic acid-co-acrylic acid, which can promote tissue ingrowth into the scaffold and / or function as an antibacterial agent, particularly when formed as a fiber. ) (PGSA). PGSA scaffolds may be useful as a substitute for conventional surgical sutures and staples and / or waterproof sealants for anastomosis of luminal organs (eg, tubes, intestines, etc.), 2D meshwork (eg, Can serve as a treatment for hernias, ulcers, burns, etc.) and / or wound dressings (eg, hemostatic patches, etc.). PGSA can be combined with glycerol so that the scaffold can remain in place for longer periods of time, for example up to 20 days.

  In yet another embodiment, the scaffold can be made of poly (ε-caprolactone) (PCL) that can be blended with silk fibroin (SF) and formed into a very thin film. PCL / SF blends may have very high biocompatibility properties and / or improve cell adhesion and / or proliferation to the scaffold. For example, when implanted in a tissue, the scaffold releases fibroin into the tissue, thereby facilitating faster healing, near immediate hemostasis, and / or attracting more fibroblasts. obtain. The PCL component may further assist the healing process by providing mechanical compression of the wound tissue. A higher PCL content can result in better mechanical properties, while a higher SF content can result in better degradation properties. In general, the PCL content can range from about 50 to 90% weight / volume and the SF content can range from about 10 to 50% weight / volume. For further details of the properties and manufacturing methods of scaffolds made with PCL and SF, see Jun Sik Lim et al., Which is incorporated herein by reference in its entirety. , Fabrication and Evaluation of Poly (epsilon-caprolactone) / Silk Fibrin Blend Nanofibrous Scaffold, Biopolymers 97: 265-275 (2012).

  In yet further embodiments, the scaffold may comprise gelatin coated PCL. The scaffold can be placed in one or more layers, for example, PCL functions as a substrate. PCL may function to increase the mechanical strength of the scaffold and / or may support fibroblast adhesion and cell proliferation. Further details of the properties and methods of manufacture of scaffolds made with 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. Biomed Mater Res 83A: 372-382 (2007).

  Table 1 below summarizes exemplary molecular weight ranges, approximate absorption times, and average dimensions for films made with the porous polymer scaffold materials described above. Those skilled in the art will appreciate that the ranges shown in Table 1 are not intended to be limiting and that the molecular weight of any polymer described herein can be varied to obtain the desired degradation characteristics. Will.

  Other suitable adjuncts may include absorbent polyurethanes, such as polyurethanes derived from aromatic absorbent isocyanates and chain extender diols, which may be similar to methylene bis (phenyl isocyanate) (MDI). The absorbent polyurethane can be configured to hydrolyze into a safe and biocompatible product when hydrolyzed. Non-limiting examples of hydrolyzable aromatic isocyanates that can be used to form the absorbent polyurethane include glycolic acid-diisocyanate, caprolactone-diisocyanate, glycolic acid-ethylene glycol-glycolic acid, glycolic acid-diethylene glycol-glycolic acid, lactic acid -Diethylene glycol-lactic acid, triester of glycolic acid and trimethylpropane, and tetraester of glycolic acid and pentaerythritol.

  Another particularly useful adjunct that may be used with the disclosure provided herein is a material that forms the multilayer dressing disclosed in US 2006/0257458, which is incorporated herein in its entirety. They are particularly suitable for absorbing and retaining body fluids when pressed, for example, by application of staples. Other exemplary non-limiting examples of synthetic materials that can be used with the disclosure provided herein as, for example, buttresses include polydioxanone films or polyglycerol sebacic acid (sold under the trademark PDS®) ( Biodegradable synthetic absorbent polymers such as PGS) film, or PGA (polyglycolic acid and its various forms sold under the trademarks Vicryl, Dexon and / or Neoveil), PCL (polycaprolactone), PLA or PLLA (poly Lactic acid), PHA (polyhydroxyalkanoate), PGCL (polygrecapron 25 sold under the trademark Monocryl), PANACRYL (Ethicon, Inc. (Somerville, NJ)), polyglactin 910, polyglyconate, PGA / MC (polyglycolic acid-trimethylene carbonate sold under the trademark Biosyn), polyhydroxybutyric acid (PHB), poly (vinyl pyrrolidone) (PVP), poly (vinyl alcohol) (PVA), polydioxanone (PDO) and various of these Or other biodegradable films formed from any of the blends or copolymers described above (for example, sold under the PDS trademark). Blends and / or copolymers of any of the above materials can be tailored to have a desired molecular weight and / or degradation rate.

  Some non-limiting examples of bio-derived materials that can be used with the disclosure provided herein, for example, as a sealant material include platelet poor plasma (PPP), platelet rich plasma (PRP), starch, chitosan, alginic acid, Fibrin, thrombin, polysaccharide, cellulose, collagen, bovine collagen, bovine pericardium, gelatin-resorcin-formalin adhesive, oxidized regenerated cellulose, regenerated cellulose, mussel adhesive, poly (amino acid), agarose, polyether ether ketone , Amylose, hyaluronan, hyaluronic acid, whey protein, cellulose gum, starch, gelatin, silk, Progel (R), Baxter (Deerfield) available from Davol Inc (Warwick, Rhode Island) Suitable for mixing with biomaterials, such as TachoSil® available from Illinois), or any combination of materials that will be apparent to those skilled in the art given the disclosure provided herein And other materials suitable for introduction at the wound or defect site. The biomaterial can come from many sources, for example, a patient into which the biomaterial is implanted, a human who is not the patient into which the biomaterial is implanted, or other animals.

  Additional disclosures regarding synthetic or polymeric materials and biomaterials that can be used with the disclosure provided herein include US Pat. No. 7,772,352, WO 2014/016819, US Patent Application Publication 2006. No. 0257458, No. 2012/0080335, No. 2012/0083835, No. 2013/0256372, No. 2013/0256365, No. 2013/0256376, U.S. Patent Application No. 13 / 710,931 ( Name “Electrosurgical End Effector Tissue Tacking Features”, filed December 11, 2012, and No. 13 / 763,192 (name “Multiple Thickness Implantable Layer”) s for Surgical Stapling Devices ", found in the February 8, 2013), each of which in its entirety is incorporated herein by reference.

Auxiliary parts with strain relief mechanisms Tissue auxiliary parts can have a wide variety of configurations, but generally such that the tissue comes into contact with the tissue when clamped between the cartridge assembly and the anvil of the surgical stapler. Composed. One advantage of the tissue assist is the tendency to prevent or minimize leakage, such as leakage of bodily fluids or gases. The tissue assisting portion may block the following mechanisms: occlusion of holes or crevices that occur at the staple puncture site, limiting movement of tissue around the staple puncture site to prevent enlargement of the size of the staple hole, and / or Or perform this function by preventing one or more of the tissue tears and minimizing the strain gradient that occurs between the tissue constrained within the staple line and the free tissue adjacent to the staple line. can do.

  In certain aspects, an adjunct can be used to distribute the compression clamping force throughout the tissue to absorb and retain beneficial fluid at the treatment site, improve staple acquisition, and / or promote hemostasis. is there. In some embodiments, a first piece of auxiliary material may be attached to the cartridge assembly and a second piece of auxiliary material may be attached to the anvil; however, any suitable number of auxiliary materials may be placed in the end effector. May be positioned.

  The tissue assist can include a wide variety of mechanisms and can be formed from a wide variety of materials to assist in sealing the tissue on the staple line and / or to prevent the formation of a leak in the tissue. it can. For example, the tissue assist may have a central region configured to be deployed on the tissue and attached to the tissue via staples. The tissue assist may further include an outer region (also referred to herein as a wing region or wing portion) that can be positioned outside the staple line when the assisting material is stapled to the tissue. The wing portion may help to distribute the strain more evenly and / or minimize the strain gradient across the tissue as the tissue deforms or otherwise stretches during normal body function. In some embodiments, a sealant may be used with an auxiliary material to help seal the stapled tissue. The sealant may be introduced into the patient in a first liquid state and may be configured to transition to a second cured or solid state after a predetermined time has elapsed. When the sealant is in the first liquid state, the sealant can penetrate into the adjunct and / or staple line and subsequently harden therein to facilitate complete sealing of the tissue. In this manner, the adjunct and sealant can cooperate to provide a better and more complete staple line seal as compared to using only the tissue aid or sealant.

An exemplary auxiliary having a central region and a wing region is shown deployed on the tissue of FIGS. 17A and 17B. As shown in FIG. 17A, the auxiliary portion 1000 can include a center 1002 for receiving staples therebetween and a wing portion 1004 adjacent to the center region 1002. The central region 1002 of the auxiliary portion 1000 may be sized and shaped to match the size and shape of the cartridge assembly 52 and / or anvil (not shown). For example, FIG. 17A shows an auxiliary portion 1000 having a central region 1002 that is sized and shaped to match the tissue contacting surface of the cartridge assembly 52. That is, the central region 1002 can be approximately the same size as the tissue contacting surface. The central region 1002 of the auxiliary portion 1000 shown in FIG. 17A is substantially defined by a proximal edge portion 1002p and a distal edge portion 1002d, and a first side edge portion 1002a and a second side edge portion 1002b. May have an elongated rectangular shape. The proximal edge 1002p of the central region 1002 may terminate in a proximal mating mechanism 1006 for coupling to the distal end 14d of the shaft 14 of the stapler 10. At least two of the remaining three edges of the central region 1002 may include a wing portion 1004 that extends around the periphery and forms the outer edge of the auxiliary portion 1000. For example, as shown in FIG. 17A, the wing portion 1004 of the auxiliary portion 1000 can extend around the first and second side edges 1002a, 1002b, and the distal edge of the central region 1002 It can extend distally beyond 1002d. In one embodiment, the auxiliary portion 1000 is sized and positioned on the cartridge assembly 52 so that it can be separated by a stapler cutting member during use. In practice, the distal region of the wing portion 1004 is always cut. As shown, the wing portion 1004 may have a modified structure that is different from the structure of the central region 1002. In the illustrated embodiment, the central region 1002 may be substantially solid , such as a film, and the wing portion 1004 may be a mesh. As shown in FIG. 17B, when the auxiliary portion 1000 is stapled to the tissue T, the central region 1002 can have one or more columns / rows of staples 1008 extending therebetween, and the wing portion 1004 can extend laterally away from the staple 1008. As shown, the auxiliary portion 1000 stapled to the tissue T has half of the auxiliary material shown in FIG. 17A because the stapler cutting member cuts the tissue while the staple 1008 is deployed thereon. Including. The mesh-like wing portion 1004 bends when the tissue expands and contracts, and disperses strain more evenly over a larger area than when the auxiliary portion 1000 includes only the central region 1002 (or minimizes strain gradient). can do. For example, the wing portion 1004 can expand and contract in a direction transverse to the longitudinal axis LC of the central region 1002. This can help prevent the formation of pressure points that can create leaks in the stapled tissue after the tissue has repeatedly expanded and contracted. In a particular embodiment, the mesh may be formed from the same film material yarn as the central region 1002 extending in a cruciform pattern. As shown in the figure, the longitudinal axis L1 of the half of the yarn can be arranged at an angle θ1 of about 45 degrees with respect to the longitudinal axis LC of the central region 1002, and the longitudinal direction of the remaining half of the yarn The axis L2 can be positioned at an angle θ2 of about 45 degrees with respect to the longitudinal axis LC of the central region 1002 or can be positioned at other angles with respect to the central region 1002. As will be apparent to those skilled in the art, the wing portion 1004 of the auxiliary portion 1000 is formed by meshing the wing portion 1004 with a mesh wing region or a solid central region 1002 by, for example, laser cutting or punching a shape such as a square, a circle, or a diamond from a film. Can be formed using a wide variety of known manufacturing techniques. As shown in FIG. 17B, two identical auxiliary portions 1000, 1000 ′ can be stapled into tissue, and in certain aspects, these auxiliary portions 1000, 1000 ′ are substantially sized, shaped, and structured. May be the same.

  Another embodiment of the auxiliary portion 1010 is shown in FIG. 18, which also includes a central region and a wing region. In this embodiment, the wing portion 1014 has a plurality of openings 1018 formed therein that may allow the wing portion 1014 to flex with the tissue T during expansion and contraction of the tissue T. The opening 1018 can have a wide variety of sizes, shapes, and structures, and can be circular, elliptical, rectangular, etc., and can be positioned at various locations throughout the wing portion 1014. In the illustrated embodiment, the openings 1018 are slits positioned in a plurality of rows, the rows being substantially parallel to the longitudinal axis LC of the central region 1012. The longitudinal axis of the slit 1018 may be parallel to the longitudinal axis LS of the staple 1008. Many longitudinal rows and many openings 1018 arranged in each row may vary. In the illustrated embodiment, the row adjacent to the central region 1012 may have a smaller number of openings 1018 as compared to the row adjacent to the outermost edge 1014a of the wing portion 1014. For example, a row adjacent to the central region 1012 may have three openings 1018 formed therein, while a row adjacent to the outermost edge 1014a of the wing portion 1014 is within it. There may be four openings 1018 formed. In this way, the flexibility of the wing portion 1014 can be improved from the central region 1012 to the lateral edges, and strain distribution across the tissue T can be further promoted.

  Figures 19A and 19B illustrate another embodiment of a tissue assisting portion having a wing for distributing strain throughout the tissue. FIG. 19A shows an auxiliary portion 1020 having a central region 1022 and a wing region 1024, both of which are formed from a plurality of layers. In the foregoing embodiment, the central region 1022 can have a generally rectangular shape. The top layer of material can define a central region 1022, and any of the regions 1022, 1024 can be formed from multiple layers. The central region 1022 can have a substantially rectangular shape, but may have other shapes. As shown in FIG. 19A, the top layer of material 1026t can define a central region, and a flexible material such as PDS®, PGA, Neoeil®, ORC, or other polymer, And biomaterial structures disclosed herein or combinations thereof. The material geometry and structure (material thickness, fiber orientation, polymer chain orientation, pore pattern, etc.) can be used to create the desired isotropic or anisotropic deformation characteristics. The bottom layer of material 1026b may also be substantially flexible, and in certain embodiments may be more flexible as compared to top layer 1026t. The bottom layer 1026b may have a shape that matches the shape of the top layer 1026t and is shown as having a generally rectangular shape. The bottom layer 1026b may have a larger surface area compared to the top layer 1026t such that the bottom layer 1026b extends beyond the lateral edges of the top layer 1026t. As shown, the side edge of the bottom layer 1026b may be scalloped with a plurality of semicircular protrusions 1028 along the wing portion 1024. These semicircular protrusions may be spaced apart at equal distances along the edge, or separated into groups of 2, 3, 4 and the group of protrusions being the edge May be arranged at equal distances along. When stapling the assisting portion 1020 into the tissue, the top layer 1026t of material 1026t is positioned away from the tissue and does not contact the tissue directly, while the bottom layer 1026b contacts the tissue directly. Furthermore, the protrusion can be positioned away from the staple row, and the strain can be dispersed throughout the tissue T to prevent the formation of a leak. The bottom layer 1062b is formed from a flexible material, such as PDS®, PGA, Neoveil®, ORC, or other polymer, and the biological material structure disclosed herein or combinations thereof. can do. The material geometry and structure (material thickness, fiber orientation, polymer chain orientation, pore pattern, etc.) can be used to create the desired isotropic or anisotropic deformation characteristics. In one embodiment, at least one of the top layer 1062t and the bottom layer 1062b is at least partially composed of PDS® to help bond adjacent layers. In one embodiment, both the top layer 1062t and the bottom layer 1062b can be made from an absorbent material.

  The auxiliary material can be configured in various ways. For example, the auxiliary material can be formed from a continuous material. That is, as shown in FIG. 19B, the auxiliary portion 1020 may include a single layer including a wing portion 1024 having a central region 1022 and a plurality of protrusions 1024 for strain distribution. In other embodiments, the auxiliary material may include more than two layers of material. For example, one or more intermediate layers (not shown) of material may be positioned between the top and bottom layers, which is more rigid compared to the top and bottom layers. May be. The layers can be bonded together using known manufacturing techniques such as laminates, adhesives and the like. The protruding portion 1028 of the wing portion 1024 of the auxiliary material can also be formed using a known manufacturing technique such as a laser cutting method, a stamping method, or a punching method.

  Another exemplary auxiliary material is shown in FIG. 20, which includes wing regions having a wide variety of geometric shapes. As shown in the figure, the auxiliary portion 1020 ′ may have a wing region 1024 ′ extending around the outer edge of the central region 1022 ′, and may be formed inside the wing region 1024 ′. There may be a plurality of evenly spaced surface features 1028 '. The surface feature 1028 'can have a generally boomerang-shaped shape and can include a bend 1023' and first and second arms 1025 ', 1027' extending therefrom. As shown in FIG. 20, the bent portion 1023 ′ can be positioned along the edge portions 1022a ′, 1022b ′, 1022c ′ of the central region 1022 ′, and the end portions 1025t ′ of the arms 1025 ′, 1027 ′, 1027t ′ can be positioned at the outer edge of wing region 1024 ′. In this way, the thickness of the wing region 1024 'in the direction transverse to the longitudinal axis of the central region 1022' can vary, and the thickness of the wing region 1024 'in the direction parallel to the longitudinal axis of the central region 1022'. It can also change. These surface features 1028 'can be formed by removing a part of the auxiliary material 1020' using a known manufacturing technique such as a laser cutting method, a stamping method, or a punching method.

  21A-21C illustrate an auxiliary material that includes a wing portion with a modified edge. For example, the wing portion 1034 of the assist portion 1030 of FIG. 21A has a crest portion 1034p and a valley along its entire length so that the wing portion 1034 is atraumatic and does not increase the likelihood of forming a leak in the tissue. It may have a sinusoidal outer edge with a portion 1034v. The wing portion 1034 ′ of FIG. 21B includes a first material 1036 ′ that forms a central region 1032 ′ and a wing portion 1034 ′, the wing portion 1034 ′ loops around the central region 1032 ′, and the central region 1032 ′. And has a curvilinear edge that extends to return to the edge and then forms an elliptical opening 1035 '. In certain embodiments, the second material 1038 'is disposed within the oval / teardrop shaped opening 1035', such as by laminating to the first material 1036 'to form an auxiliary portion 1030'. The thickness of this second material 1038 'can be different from the thickness of the first material 1036'. For example, as shown, the thickness of the second material 1038 'may be less than the thickness of the first material 1036'. The wing portion 1034 '' of FIG. 21C has a plurality of openings 1035 '' such as triangular openings formed therein that can form a protrusion 1038 '' similar to the protrusion 1028 shown in FIG. 19B. Although it may have, the protrusions 1038 '' may have corners rather than rounded edges. The auxiliary portions 1030, 1030 ', 1030' 'of FIGS. 21A-21C can be formed from a variety of materials, such as any flexible or stretchable polymer material described herein. In use, any one of the assisting portions 1030, 1030 ', 1030' 'can be stapled to the tissue, and any of the corresponding wing portions can extend beyond the staple line. . As shown in FIG. 21D, the assisting portion 1030 can be stapled to the tissue T, the wing portion 1034 can be positioned outside the staple 1008 forming the staple line, and the central portion 1032 is inside the staple line. Can be positioned. In certain aspects, as the tissue expands and contracts, the assisting portion may stretch or bend in a direction across the staple row, or may extend in multiple directions, such as along the outer surface of the tissue T as shown. Can be configured. One skilled in the art will appreciate that the edge of the wing portion may be shaped in ways other than the illustrated embodiment.

22A-22C illustrate another embodiment of an auxiliary material that includes a wing portion with a modified edge. As shown in FIG. 22A, the auxiliary material 1040 may be a woven fabric. The central region 1042 of the auxiliary portion 1040 can be formed from a woven material having a higher density compared to the woven material of the wing portion 1044 of the auxiliary portion 1040. In other embodiments, as shown in FIG. 22B, all surfaces of a denser woven material may be wrapped with a less dense woven material. In either embodiment, the wing portion 1044 can have a flexible atraumatic edge 1046 that is less likely to puncture or otherwise damage the tissue and cause the tissue to form a perforation. The auxiliary portion 1040 can be configured to wick and / or absorb liquid therein. For example, in the embodiment of FIG. 22C, the top layer 1048t ′ of the material of the auxiliary portion 1040 ′ is shown positioned over the bottom layer of the material 1048b ′, and the liquid 1047 ′ passes through the top layer of material. Wicked in the space between 1048b 'and the bottom layer 1048t'. These adjuncts can be formed from a variety of woven materials known in the art, such as ETHISORB® (Ethicon, Inc. (Somerville, NJ)). In one embodiment, the central region 1042 may be a solid but deformable absorbent material film.

  An auxiliary material for use with a stapler that deploys variable thickness staples is shown in FIGS. As shown in the figure, the thickness of the auxiliary portion 1050 can change in the lateral direction indicated by the arrow from the central axis 1056 to the outer edge of the auxiliary portion 1050. That is, the auxiliary portion 1050 may have a thickness that decreases / taps in the lateral direction from the central axis 1056 of the auxiliary portion 1050 to the outer edge thereof. As in the previous embodiment, the auxiliary material 1050 can include a central region 1052 and a wing portion 1054. The auxiliary portion 1050 may include an elongated slot portion 1058 formed along the central axis 1056 of the auxiliary portion 1050 and having a size and shape that matches the size and shape of a cutting member (not shown). In the illustrated embodiment, the elongated slot 1058 has a substantially rectangular shape. FIGS. 23B and 23C provide an end view of the cartridge assembly 52 and anvil 54 having a laterally varying thickness so that the stapler 10 can deploy staples of various heights (not shown). As shown, the thickness TO of the anvil 54 near the cutting member slot may be thicker than the thickness TE of the anvil 54 near its side edge. The auxiliary portion 1050 can be coupled to the cartridge assembly 52 and / or the anvil 54 such that at least the central region 1052 of the auxiliary portion 1050 is in direct contact with the tissue contacting surfaces 60, 58 of the cartridge assembly 52 / anvil 54. As shown, the tissue contacting surface 58 of the anvil 54 may include one or more mating points 1057 that attach the auxiliary portion 1050 to the anvil 54. As described in more detail below, the wing portion 1054 of the auxiliary portion 1050 may be wrapped around and attached to the cartridge assembly 52 and / or the anvil 54. In this way, the tissue contacting surface 1053 of the first auxiliary portion 1050 can be substantially planar, and the tissue contacting surface 1053 ′ of the second auxiliary portion 1050 ′ disposed on the cartridge assembly 52. Can be arranged in parallel. As shown in FIG. 23D, when the assisting portions 1050, 1050 'are stapled to the tissue, the wing portions of the assisting portion 1050 are disposed between the staples 1008 and extend toward the distal end TE of the tissue T. While the second portion of the auxiliary portion 1050 can extend away from the cut end TE of the tissue T to distribute strain to the tissue T similar to the wing portion described above. . As shown, the auxiliary portion 1050 'can have similarly positioned portions 1052', 1054 '.

  In order to ensure that the auxiliary material remains in the desired position, any auxiliary material may include various mechanisms for increasing the friction between the auxiliary material and the tissue. For example, the auxiliary portions 1060, 1060 'of FIGS. 24A and 24B include a plurality of teeth 1061, 1061' that are formed on the tissue contacting surface and terminate at points 1063, 1063 'that can penetrate the tissue. As shown in the drawing, the plurality of teeth 1061, 1061 'can be spaced apart at an equal distance in the side surface direction of the auxiliary portions 1060, 1060'. The teeth 1061, 1061 'can be formed in the auxiliary portion 1060, 1060' using a wide variety of known manufacturing techniques such as compression molding, cutting / stamping, punching and the like. For example, the auxiliary portion 1060 of FIG. 24A may be compression molded, while the auxiliary portion 1060 'of FIG. 24B may be formed by stamping slits 1065' in the material forming the teeth 1061 '. As shown in FIG. 24C illustrating multiple rows of auxiliary portions 1060 ′, the gap between the teeth 1061, 1061 ′ can be pushed into the tissue T to create a lock that prevents sliding of the auxiliary portions 1060, 1060 ′. . In another embodiment shown in FIG. 25A, the assisting portion 1060 ″ may include a plurality of micropillars 1063 ″ formed on its tissue contacting surface, such that the micropillars 1063 ″ penetrate the tissue T. It has a configured needle shape. As shown in FIGS. 24D and 25B, the teeth 1063 and / or micropillars 1063 '' can penetrate directly into the tissue T, so that the assisting portions 1060, 1060 'are relative to the staple 1008 when the tissue T expands and contracts. It can prevent sliding. In a particular embodiment, the micropillar 1063 '' 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 the auxiliary material is shown in FIGS. In this embodiment, an auxiliary material, such as the auxiliary portion 1000 of FIGS. 17A and 17B, is used with a tip extension member 1070 that is connectable to the anvil 54 and / or cartridge assembly 52 of the surgical stapler 10. As shown in FIG. 26A, the distal end 1004d of the auxiliary portion 1000, i.e., the distal end 1004d of the wing portion 1004, may terminate at or at the most distal end 52d of the cartridge assembly 52. As shown in FIG. 26B, the distal end 1004d of the auxiliary portion 1000, i.e., the distal end 1004d of the wing portion 1004, may terminate at, or proximal to, the distal-most end portion 54d of the anvil 54. Tip extension member 1070 can be added to cartridge assembly 52 and / or anvil 54 to replace or supplement the distal portion of aid 1000. The proximal end 1070p of the tip extension member 1070 is formed and dimensioned therein so as not to occlude or cover a slot formed in the anvil 54 to receive a cutting member (not shown). A notch 1072 may be provided. The notch 1072 can be releasably coupled to the distal end 54d of the anvil 54 along a curved portion of the anvil 54 distal to the tissue contacting surface of the anvil 54 in various ways, such as with an adhesive. First and second extension arms 1074a, 1074b may be defined. The distal most end 1070d of the tip extension member 1070 may be substantially circular. A mechanism for releasing the distal portion 1076 of the tip extension member 1070 from the proximal end 1070p of the tip extension member 1070 may also be provided. In certain aspects, the release mechanism may consist of a perforation 1078 extending across the longitudinal axis LN of the tip extension member 1070. During use, the auxiliary portion 1000 can be positioned on the anvil 54 and the tip extension member 1070 can also be coupled to the anvil 54. As shown in FIG. 26B, the anvil 54 and cartridge assembly 52 can grasp the tissue T therebetween, and a portion of the auxiliary portion 1000 can extend distally beyond the tip extension member 1070. . That is, the distal end 1070 d of the tip extension member 1070 can be positioned distal to the distal end 1004 d of the auxiliary portion 1000. The anvil 54 and cartridge assembly 52 can deploy the staple 1008 through the tissue T and the assisting part 1000, while the wing region 1004 of the assisting part 1000 does not include the staple 1008 extending therethrough. The wing region 1004 of the auxiliary part 1000 can be in direct contact with the tissue T, and the tip extension member 1070 can be positioned above the wing region 1004. In certain aspects, the tip extension member 1070 may be a semi-flexible material and is used with the assisting part 1000 to help relieve strain on the tissue T and / or provide strength to the assisting part 1000. May be. In use, the distal end of the tip extension member 1070 can be removed from the anvil 54 and / or cartridge before, during, and / or after the tissue T is stapled.

  Although the above-described mechanism of the auxiliary part is illustrated as an individual embodiment, the auxiliary part may have any combination of the above-described mechanisms.

Attachment and Release Mechanism Between End Effector and Auxiliary A variety of mechanisms such as cartridge assembly 52 or anvil 54 may be used to attach an auxiliary portion having a wing to the end effector and subsequently release it from the end effector. it can. Although the embodiments described below include features formed on the anvil 54, any of these features can be formed on the cartridge assembly 52 to fit the auxiliary portion into the cartridge assembly 52. FIGS. 27A-27B show auxiliary materials 1000 ′, 1000 ″ having a fitting mechanism that is key-coupled with a corresponding fitting mechanism formed on the anvil 54. More particularly, FIG. 27A shows an auxiliary portion 1000 ′ having a plurality of cylindrical protrusions 1003 ′ formed on a surface 1007 ′ oriented away from the tissue contacting surface 1005 ′ of the auxiliary portion 1000 ′. . FIG. 27A shows three cylindrical protrusions 1003 ′ spaced apart along an axis parallel to the longitudinal axis LA of the anvil 54, but any number of protrusions at various locations along the auxiliary part 1000 ′. The portion 1003 ′ may be formed. The outer surface 54L of the anvil 54 may have a plurality of recesses 53 configured therein to receive a plurality of protrusions 1003 ′ from the auxiliary portion 1000 ′. In one embodiment, the height of the columnar protrusion 1003 ′ (not shown) may vary and may range from about 0.25 to 1.00 mm, with the height of the auxiliary portion 1000 ′. Measure perpendicular to the surface 1007 '. The protrusion 1003 ′ formed on the auxiliary part 1000 ′ may have other dimensions and shapes. As shown in FIG. 27B, in another embodiment, the auxiliary portion 1000 ″ may have a single elongated rectangular protrusion 1003 ″ that extends parallel to the longitudinal axis LA of the anvil 54. . The outer surface of the anvil 54 may further include a corresponding elongated rectangular recess 53 ′ for receiving the rectangular protrusion 1003 ″ therein when the auxiliary portion 1000 ″ is wrapped around the anvil 54. Although the height (not shown) of the rectangular protrusion 1003 '' may be various, it may be in the substantially same range as the height of the above-described columnar protrusion 1003 ′. Although only the first outer side 54L of the anvil 54 is shown in FIGS. 27A and 27B, those skilled in the art will also form the same protrusion on the second outer side (not shown) of the anvil 54. You will understand what you can do. Similarly, the same concave portion can be formed on the second outer surface (not shown) of the auxiliary portions 1000 ′ and 1000 ″.

  The auxiliary can be coupled to the anvil / cartridge assembly in other ways. As shown in FIGS. 28A and 28B, the auxiliary portion can be coupled to the anvil 54 with a strand of suture 1003 ″ ″. The suture 1003 "'can extend from the first outer surface 54L of the anvil 54 across the tissue contacting surface of the anvil to the second outer surface 55L of the anvil 54. First and second recesses 53 ″ ″, 55 ′ ″ can be formed on the first and second outer surfaces of the anvil 54, and the first end of the suture 1003 ′ ″ is the first One recess 53 '' 'can be received in the first recess 53' '' and the second end can be received in the second recess 55 '' '. The length of the suture 1003 ′ ″ and / or the dimensions of the recesses 53 ′ ″, 55 ′ ″ are such that the distal end of the suture 1003 ′ ″ is positioned within the recesses 53 ′ ″, 55 ′ ″. Can be selected to teach the suture 1003 ″ ′. As shown in FIG. 28B, as the cutting member 59 is advanced through the anvil 54 during and / or after the staple 1008 is deployed in the tissue T, the cutting member 59 cuts the suture 1003 ′ ″, Therefore, the distal end portion of the suture thread 1003 ′ ″ slides out of the recesses 53 ′ ″ and 55 ′ ″, thereby releasing the auxiliary portion from the anvil. FIGS. 29A and 29B show a strand of suture 1003 ″ ″ that extends around the anvil 54 and couples the multi-layer auxiliary 1020 to the anvil 54. As in the embodiment described above, a cutting member (not shown) is advanced relative to the anvil 54 to cut the suture 1003 ′ ″ from the recesses 53 ″, 55 ′ ″ of the anvil 54. The suture 1003 ′ ″ can be released to release the auxiliary portion 1020. As will be apparent to those skilled in the art, any number of suture strands may be used to couple the auxiliary portion to one of the cartridge assembly 52 and anvil 54, and a recess formed therein. May be different as long as they are configured to receive a portion of the suture therein.

  FIGS. 30A-30B illustrate other mechanisms for attaching the auxiliary to the anvil / cartridge assembly. In this embodiment, the anvil 54 of the surgical stapler 10 can be advanced in a slot 61, referred to as a longitudinal track, with a cutting member 59 that can move between the proximal and distal ends 61p, 61d of the track 61. Including. As shown in FIG. 30B, a driver 1081 that includes first and second elongated members (not shown) may be disposed in the longitudinal track 61. Three cylindrical protrusions (not shown) extend from the elongate member into the recesses 53 "", 55 "" formed in both outer faces of the anvil 54, but along the driver There may be any number of protrusions spaced apart and having various other shapes. As shown in FIG. 30C, the first driver 1081a may be generally elongated and may have a plurality of protrusions 1083, such as three protrusions 1083 that are oriented across the longitudinal axis of the driver. Here, the protrusion 1083 has a cylindrical shape. The wing portion 1084 of the auxiliary material 1080 can be disposed on the outer surface of the anvil 54 and a plurality of protrusions oriented across the longitudinal axis LA of the anvil 54 when the auxiliary material 1080 is coupled to the anvil 54. Part 1083 ′ may be included. As shown in FIG. 30D, the auxiliary material 1080 is adapted to mate with the first set 1083 ′ of protrusions for mating with the first outer surface of the anvil 54 and the second outer surface of the anvil 54. A second set of protrusions 1083 ''. Prior to use, the first driver 1081 a can be positioned on the first outer wall of the track 61 and the second driver 1081 b can be positioned on the second outer wall of the track 61. Each proximal end of the drivers 1081a, 1081b has a width W1 between the drivers 1081a, 1081b at the proximal end of the track 61 when the drivers 1081a, 1081b are disposed in the track 61, and / or at the protrusion 1083 ′. Alternatively, it can have slanted portions 1085p, 1087p to be larger compared to the distance W2 between the drivers 1081a, 1081b distal to the protrusion 1083 ′, this width being the width of the anvil 54 shown in FIG. 30E. Measured across the longitudinal axis LA. Furthermore, the width W2 between the drivers 1081a and 1081b distal to the proximal end 61p of the track 61 may be smaller than the width WC of the cutting member 59. In this way, the cutting member 59 can be advanced toward the distal end 54d of the anvil 54, the width between the drivers 1081a, 1081b can be increased, and the protrusion 1083 is as shown in FIG. The auxiliary portion can be released from the anvil 54 by pushing the corresponding protrusion 1083 ′ on the auxiliary portion 1080 away from the anvil. In certain aspects, the assisting portion 1080 is flat so that the assisting portion 1080 can be better released from the anvil 54 when the cutting member 59 advances in the track 61 and applies force to the drivers 1081a, 1081b. It can be biased to a substantially planar shape.

  A mounting mechanism for mounting the auxiliary section on the anvil / cartridge assembly is shown in FIGS. The mounting mechanism 1090 can have a wide variety of sizes, shapes, and structures, and a first curved arm 1092a having a radius of curvature that matches the radius of curvature of the first and second outer surfaces 54L, 55L of the anvil 54. And a second curved arm 1092b, and the arms 1092a, 1092b can be terminated with oblique mechanisms 1093a, 1093b that can be gripped by the user. The mounting mechanism 1090 can have a planar base 1094 from which the first and second curved arms 1092a, 1092b extend. As shown in FIG. 31B, the base 1094 of the mounting mechanism 1090 extends perpendicular to the base 1094 for insertion into the cutting member slot 54s of the anvil 54 and is disposed along the central longitudinal axis of the mounting mechanism 1090. The track extension 1094e may be further included. As shown in FIG. 31A, the first inner surface 1094a of the mounting mechanism 1090 can be defined by a first curved arm 1092a and a first portion of the base 1094 from the first arm 1092a to the track extension. Similarly, the second inner surface 1094b of the mounting mechanism 1090 can be defined by a second curved arm 1092b and a second portion of the base 1094 that extends from the second arm 1092b to the track extension 1094e. In this manner, the mounting mechanism 1090 can be generally E-shaped for receiving the anvil 54. As shown in FIG. 31B, the auxiliary part 1000 having the central region 1002 and the wing region 1004 can be positioned between the inner surface of the mounting mechanism 1090 and the tissue contact surface of the anvil 54 and can be sandwiched between them. As is done, the mounting mechanism 1090 is clamped to the anvil 54. The track extension 1094e can help achieve a close fit between the mounting mechanism 1090, the auxiliary 1000, and the anvil 54, with substantially no gap therebetween. After the auxiliary portion 1000 is coupled to the anvil 54, such as using any attachment mechanism described herein, such as the attachment mechanism 1052, the mounting mechanism 1090 may be removed from the anvil 54. As shown in FIG. 31C, this can be achieved, for example, by pushing the oblique mechanisms 1093a, 1093b of the bending arms 1092a, 1092b away from each other to release the anvil 54 on which the auxiliary part 1000 is mounted.

Another exemplary mounting mechanism is shown in FIGS. The mounting mechanism 1090 'can be packaged as a kit with the end effector of the stapler. Alternatively, the mounting mechanism 1090 ′ may be packaged separately. As shown in FIG. 32A, the anvil 54 and cartridge assembly 52 of the end effector 50 can include a pre-loaded auxiliary material 1000, or in another non-illustrative embodiment, the auxiliary material 1000 can be removed from the packaging 1100. It can be secured to the anvil 54 and cartridge assembly 52 after removal. The mounting mechanism 1090 ′ wraps the wing portion 1004 of the auxiliary portion 1000 around the outer surfaces 54L, 53L of the anvil / cartridge assemblies 54, 52 so that the wing portions are passively coupled to the anvil / cartridge assemblies 54, 52. Can be configured. As shown in FIG. 32B, the loading mechanism 1090 ′ can be configured to contact the tissue contacting surface of the anvil / cartridge assembly 54, 52 with the central region (not shown) of the auxiliary portion 1000, and is required. If present, a wing portion (not shown) can be configured to shape around the anvil 54. The mounting mechanism 1090 ′ can be molded from a single molding material having an upper retaining portion 1104 and a lower retaining portion 1102, the retaining portion sized and received to receive anvil / cartridge assemblies 54, 52 therein. It has a shaped channel (not shown). The shape of the channel may be substantially similar to the shape of the mounting mechanism 1090 described above, and may include any of the same mechanisms such as a track extension. The upper and lower holding portions 1104 and 1102 may be arranged at an angle θL with respect to each other, and this angle is in the range of about 10-40 degrees. The support member 1106 can extend between the lower surface of the upper holding portion 1104 and the upper surface of the lower holding portion 1102 such that the angle θL between the holding portions 1102 and 1104 is fixed. As shown, the support member 1106 may be a substantially solid member to provide rigidity to the mounting mechanism 1090 ′. The first end of the support member 1106 may terminate with a gripping mechanism 1108 that is configured to be gripped by a user (eg, between the user's thumb and a finger other than the thumb, etc.). There may also be first and second planes 1108a, 1108b. The gripping mechanism 1108 may further include one or more surface features 1110 to increase the frictional force between the user's fingers. The longitudinal axis of the gripping mechanism 1108 may be oriented perpendicular to the longitudinal axis of the stapler 10 or may be parallel to the longitudinal axis of the stapler 10. In use, the user may grasp the grasping mechanism 1108 to position the distal end 1102d, 1104d of the retaining portion adjacent to the cartridge assembly 52 and the proximal ends 52p, 54p of the anvil 54. As shown in FIG. 32B, the user can advance the distal end of the loading mechanism 1090 ′ toward the proximal end of the end effector 50, and as shown in FIG. 32C, the retaining portions 1102, 1104 can be anvil / The auxiliary material 1000 can be wound around the outer surface by sliding along the cartridge assemblies 54, 52. This allows the wing area 1004 to be temporarily secured along the outer surfaces of the cartridge assembly 52 and the anvil 54. Positioning the wing region 1004 in this manner, the user retracts the mounting mechanism 1090 ′ in the opposite direction away from the end effector 50 and is ready to insert the end effector 50 into the patient. Although a single auxiliary material 1000 mounted on the anvil 54 has been mentioned, the auxiliary material 1000 ′ can be mounted on the cartridge assembly 52 as well. The auxiliary material 1000, such as the material shown in FIGS. 32A-32C, may be a shape memory material so that the auxiliary portion 1000 is biased into a substantially straight shape. That is, once the end effector 50 is positioned within the patient, the wing region can automatically return to a substantially straight shape before leaving the end effector 50 and being deployed on tissue.

Delivery of an auxiliary part to a patient An end effector with one or more auxiliary parts connected can be delivered to various parts of the patient, such as the thoracic cavity, stomach and the like. As will be apparent to those skilled in the art, the assisting portion can be delivered through an access port such as a trocar that extends into the patient. Any of the assisting portions herein may include a mechanism that assists in delivering the assisting portion into the patient's body. For example, FIG. 33A shows an auxiliary portion 1000 having a solid central region 1002 and a mesh wing region 1004 coupled to the anvil 54 of the surgical stapler 10. Although a single auxiliary portion 1000 is shown coupled to the anvil 54, another auxiliary portion 1000 ′ may be coupled to the cartridge assembly 52 prior to inserting the end effector 50 into the patient's body. The distal portion of the auxiliary portion 1000, such as the distal portion 1004d of the wing region 1004, is around the outer surface (not shown) of the anvil 54 so as to minimize the width of the auxiliary material, as shown in FIG. 33B. The proximal portion 1004p of the wing region 1004 can be configured to be guided. Since the width of the anvil / cartridge assembly 54, 52 including the auxiliary portion 1000 thereon is approximately the same as the width of the anvil / cartridge assembly 54, 52 not including the auxiliary material, the end effector 50 and the auxiliary portion 1000 are thereby configured. Can be easily inserted into an access port such as port 1202 formed in trocar 1200. In certain aspects, this distal portion 1004d of the wing region 1004 is formed from a more rigid material compared to the rest of the wing region 1004 to help guide it into the port 1202 of the auxiliary material 1000. can do.

Stapling the assist to tissue The assisting material can include a mechanism that facilitates multiple firings of staples along the tissue. FIG. 34A shows an embodiment 1300 of the end effector 50 having a first auxiliary material and a second auxiliary material 1400, 1400 ′, where the first auxiliary material 1400 is coupled to the anvil 54 and the second auxiliary material 1400. 'Is coupled to the cartridge assembly 52. As shown, each of the aids 1400, 1400 ′ may include a plurality of layers, the layers having varying widths in a direction transverse to the longitudinal axis (not shown) of the anvil / cartridge assembly 54, 52. Can have. As the tissue is grasped between the anvil 54 and the cartridge assembly 52, the respective first tissue contact layers 1402, 1402 ′ of the auxiliary portions 1400, 1400 ′ are positioned adjacent to the tissue (not shown). be able to. In certain aspects, the first tissue contact layer 1402, 1402 ′ can be formed from a material configured to seal around staple lines, such as an elastomeric material. The first tissue contact layer 1402, 1402 ′ may have a width W 5 that is substantially equal to the width WA of the anvil 54 in a direction transverse to the longitudinal axis LA of the anvil 54, or the width of the first layer 1402. W5 may be smaller than the width WA of the anvil 54. As shown in FIG. 34A, the first tissue contact layer 1402 is not formed from a continuous piece of material, but a first portion 1402a and a cutting member slot positioned on the first side of the cutting member slot 54s. A second portion 1402b positioned on the second surface of 54s may be included. In other aspects, the first layer 1402 may be a single continuous piece of material. The second layer 1406, 1406 ′ can be positioned closer to the tissue contacting surface of the anvil 54 and can be formed from a substantially rigid material. As shown, the width W6 of the second layer 1406 may be greater than the width WA of the anvil 54. This second layer 1406, 1406 ′ may help to prevent stretching of the tissue T proximate the staple 1008. The third layer 1408, 1408 ′ is the tissue contact of the anvil 54 such that the second layer 1406, 1406 ′ is sandwiched between the first layer 1402, 1402 ′ and the third layer 1408, 1408 ′. It may be positioned closest to the surface. As shown, the third layers 1408, 1408 ′ may have a width W 7 that is greater than the width WA of the anvil 54, but less than the width W 6 of the second layer 1406. This third layer 1408, 1408 ′ may be semi-rigid to help release the strain of the tissue T as the tissue T expands and contracts. The longitudinal length of the layer, measured in the direction across the width, can also vary. Preferably, the third layer 1408, 1408 ′ is along the longitudinal axis of the anvil 54 as compared to the respective longitudinal length of the first and second layers 1402, 1402 ′, 1406, 1406 ′. Have the longest length measured. As shown in FIG. 34B, a plurality of auxiliary parts 1400, 1400 ′, 1400 ″ can be continuously arranged on the tissue in a line, and the first length of the auxiliary part 1400 depends on the longitudinal length of the layers. Layer 1402 can provide regions 1410a, 1410b that overlap the first layer 1402 ′ of another auxiliary portion 1400 ′. In this manner, the staple 1008 can still penetrate these overlapping regions, unlike multiple (eg, three or more) layers 1402, 1406, 1408 positioned in these overlapping regions. FIG. 33C shows two auxiliary portions 1400, 1400 ′ stapled to the tissue T at an angle of about 90 degrees, where the first auxiliary portion 1400 has a first end portion and a second end portion. The auxiliary portion 1400 ′ has a second end portion. As shown, the first and second end portions form a polymerized region 1410a. These aids 1400, 1400 ′ can be used to allow the user to deploy the aids to accommodate a wide variety of tissue geometries. These multi-layered auxiliary parts 1400, 1400 ′ can be varied in any number of ways. Although layers 1402, 1406, 1408 can have various thicknesses, in the illustrated embodiment, second layer 1406 has a smaller thickness than each of first and third layers 1402, 1408. . For example, the first layer 1402 can range from about 3-15 mm, the second layer 1406 can range from about 5-20 mm, and the third layer 1408 can range from about 3-20 mm. In certain aspects, these layers 1402, 1404, 1406, and 1402 ′, 1404 ′, 1406 ′ can be laminated together prior to bonding to the anvil / cartridge assembly 54, 52. In certain aspects, layers 1406 and 1406 ′ may be at least partially composed of an absorbent material such as PDS®.

Strengthening Tissue Using Sealant and Auxiliary Any of the auxiliary portions herein can be used with a sealant to help maintain the seal around the staples as the tissue expands and contracts after surgery. Sealants may have a wide variety of formulations and various viscosities and curing behaviors. Generally, the sealant can be made from a biocompatible and bioabsorbable material that can be configured to transition from a first liquid state to a second cured state via a curing process such as a polymerization reaction. The first state may be a softened state (for example, fluid, gel, foam, etc.), and the second state may be a hardened state (for example, a solid rigid member). As described in more detail below, when the sealant is in the first softened state, the sealant can flow through the conduit to the sealing cuff. The sealant can transition from the first softened state to the second cured state after a predetermined time has elapsed. In certain embodiments, the sealant can be formed from a biomaterial. In some embodiments, the sealant can assist wound healing by releasing various compounds while and / or after the sealant is cured in the patient's body. By way of non-limiting example, sealants are therapeutic agents such as wound healing promoters (eg, transforming growth factor β), antibacterial agents (eg, triclosan, ionized silver, etc.), and other known agents. Can be released over time to assist in healing tissue near the location of the sealant in the body. In one embodiment, the fibrin sealant can include two reactive components that are combined just prior to delivery to the patient, such as thrombin and a bioactive component (BAC2), fibrinogen and factor XIII. In certain embodiments, the components can be provided in a 5: 1 volume ratio of BAC2 to thrombin. In an alternative embodiment, the material may be a fibrin sealant sold under the trade name Evicel®. In another embodiment, the sealant may be blood, such as autologous blood.

  FIG. 35A shows the ancillary portion of FIG. 17B with sealant 1500 delivered thereon. As shown, the sealant 1500 can be delivered to substantially cover the central region 1002 and wing region 1004 of the auxiliary portion 1000, or in another embodiment (not shown), the sealant 1500 can be It is selectively delivered only to the central region 1002 and not to the wing region 1004.

  The sealant 1500 can be delivered to the auxiliary part in other ways and need not be delivered to the outer surface of the auxiliary part 1000. For example, FIG. 35B shows a multi-layer auxiliary 1700, 1700 'stapled to tissue T. Layers 1702, 1704 can be formed from a variety of materials, but in the illustrated embodiment, a first layer 1702 comprising a fibrous scaffold positioned adjacent to tissue T and a second comprising an elastic film. Layer 1704. A delivery tool 1706 having an injection needle 1708 can have a sealant 1500 disposed therein and can penetrate a first layer 1702 comprising a fibrous scaffold. As shown in FIG. 35C, sealant 1500 can be delivered to this first layer 1702, and then the needle 1708 can be removed from the patient's body. The sealant 1500 may be bonded directly to the tissue T and / or may be held firmly attached to the tissue by the layer 1704 and, as in other embodiments, strain 1008 on the staple line. Wing regions 1704, 1704 'may be distributed to the outer tissue. When the sealant is Evicel®, the material forms a fibrin clot from fibrinogen. Without sacrificing generality, other sealants form a hardened seal structure by a variety of mechanisms useful for sealing leak passages. By combining the sealant 1500 and the auxiliary material 1700, it is possible to prevent a leak from being formed when the tissue T expands and contracts. The auxiliary portion 1700 ′ and the layers 1702 ′ and 1704 ′ may be substantially the same as the auxiliary portion 1700 and the layers 1702 and 1704 described above.

Sealants may be used to strengthen the tissue in other ways. For example, FIGS. 36A-36C show a sealant 1500 delivered to a patient's chest cavity 1800. As shown in FIG. 35A, a system 1900 for delivering sealant 1500 can include a container or canister 1902 for receiving components A, B, C of sealant 1500 therein. In certain embodiments, components A, B, C can include acid solubilized collagen A, fibrinogen B, and thrombin C. Trocar 1200 can extend into thoracic cavity 1800 through an incision 1904 formed in patient 1906. The applicator tool 1908 can have a shaft 1910 that extends through the trocar 1200, with the distal end 1910d of the shaft 1910 terminating in the thoracic cavity. The handle assembly can be formed on the proximal end 1910p of the shaft 1900 and can be configured to be grasped by the user. The handle assembly 1912 may be a pistol grip handle assembly and may include one or more actuators such as a lever 1914 that can be rotated to actuate the device 1908. The canister 1902 and the applicator tool 1908 can be coupled together in various ways, such as via a tube 1916. The tube 1916 may be substantially flexible to facilitate movement of the applicator tool 1908 during the procedure. The canister 1902 can have a second tube 1918 coupled to the canister 1902 and connected to the gas supply S so that the gas 1920 can be delivered to the canister 1902. Examples of the gas 1920 include CO ₂ and O ₂ as non-limiting examples. In certain aspects, the gas source S may be a continuous gas source, such as a continuous CO ₂ gas source available in a hospital operating room. One or more valves (not shown) can be disposed within the tube 1916, within the handle assembly 1912, within the shaft 1910, or within any other portion of the system 1900, and the handle assembly 1912. The valve can be selectively opened and closed by actuating the actuator, such as by turning the upper actuator 1914. For example, one valve can control the flow of gas 1920 into canister 1902 and another valve can control delivery of sealant 1500 to applicator tool 1908. After stapling tissue T, such as by deploying one or more cartridge staples to lung tissue, as shown in FIG. 36B, the distal end 1910d of shaft 1910 of applicator 1908 is near staple 1008. Can be positioned. Depending on the size of the area to be coated, the distal end 1910d of the applicator tool 1908 is preferably positioned about 5-30 mm away from the staple line. A user can actuate the actuator 1914, such as by grasping the handle assembly 1912 of the applicator tool 1008 and moving the rotary lever 1914 proximally. This opens a valve located in the system 1900, begins delivery of gas 1920 to the canister 1902, and encapsulates the sealant 1500 in an atomized and sprayed directly onto the tissue T as shown. Liquid particles can be formed. In this manner, sealant 1500 can be delivered to the tissue along the staple line as shown in FIG. 36C. On top of this, the sealant 1500 cures to form a cured area 1500h, which can facilitate the formation and maintenance of a seal along the staple 1008. Further, sealant 1500 may be delivered to an assisting portion, such as any of the assisting portions described herein, not directly to tissue T. As will be apparent to those skilled in the art, the sealant can be delivered to any portion of tissue, such as only on and / or outside the staple line.

  Sealants can be delivered in a variety of ways. For example, a system 1900 'for delivering sealant 1500 is provided in FIG. 37A, which includes many of the features of FIG. 36A, such as a gas source, canister, and the like. However, in this embodiment, the system delivers atomized sealant 1500 directly through trocar 1200 and does not include an applicator tool. In this embodiment, the system need not include a valve, and delivery of gas 1920 to the canister 1902 can be conveniently controlled using a gas source valve. It is possible to atomize the sealant 1500 instead of forming encapsulated liquid particles by supplying gas to the canister 1902, and the gas 1920 produces a nebulized fog of the sealant 1600. Can be delivered at high pressure and speed. As shown in FIG. 37B, this sealant mist 1500 can spread throughout the patient's chest cavity and can be cured on any surface of the tissue, such as forming a hardened zone 1500h along the entire surface of the patient's lungs. .

  In embodiments where the sealant is blood such as autologous blood, blood can be collected from the patient and applied to the supplement. As a non-limiting example, the auxiliary material may be ORC, which is a known hemostatic agent, and blood clot formation occurs by applying blood to the ORC auxiliary material, and an effective sealing structure is obtained. . One skilled in the art will appreciate that blood, such as autologous blood, can be applied to various supplements to provide an improved sealing structure. Furthermore, those skilled in the art understand that the amount of blood applied to the adjunct may vary depending on a number of factors, including the age and condition of the patient and the identity of the adjunct, in addition to the tissue type and location. Will do. In general, however, when the supplement is an ORC material, blood may be applied in an amount in the range of about 5-10 cc for each staple line used to affix the supplement to the tissue.

Reprocessing The devices disclosed herein can be designed to be discarded after a single use or 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 equipment disassembly steps, subsequent cleaning steps or replacement of specific parts, and subsequent reassembly steps. In particular, the device can be disassembled and any number of the particular parts or parts of the device can be selectively replaced or removed in any combination. Once a particular part has been cleaned and / or replaced, the device can be reassembled for later use either at a reconditioning facility or by a surgical team immediately prior to a surgical procedure. One skilled in the art will appreciate that reconditioning of the device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. Such techniques, and the use of the resulting reconditioned device, are all within the scope of the present invention.

  In some embodiments, the devices described herein can be processed before surgery. First, obtain a new or used instrument, which may contain auxiliary materials, and clean it as necessary. The instrument can then be sterilized. In some embodiments, the instrument can be dried, eg, in an oven, with a desiccant product that can have a significantly higher humidity affinity than the adjunct. In one sterilization method, 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 rays, X-rays, or high energy electron beams. Radiation kills bacteria on the instrument and in the container. In another sterilization method, the instrument is placed in a first container such as a plastic or TYVEK bag having a water vapor permeable backing. The first container can then be packaged in a second container, such as a foil bag, that can remain open. Along with the instrument, the first and second containers can be sterilized with ethylene oxide. The second container can then be sealed so that it is not exposed to humidity. Prior to sealing, at least one of the first container and the second container includes a desiccant product to further prevent changes to one or more device components. In either method, the sterilized material can then be stored in a sterilized container so that the material remains sterile until the container is opened at the medical facility.

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

Embodiment
(1) A staple cartridge for use with a surgical stapler,
A cartridge body having a plurality of staple cavities configured to place staples therein;
Auxiliary material that fits into the cartridge body and is configured to be removed from the cartridge body when the staple is deployed from the cartridge body into tissue, wherein the auxiliary material is substantially attached to the cartridge body. includes a central portion of the solid in which is sized and shaped so as matching, and a wing portion extending along at least two sides of the central portion of said solid, as a result, the wing portion, said A staple cartridge extending beyond a lateral boundary of the cartridge body in a direction transverse to the longitudinal axis of the cartridge body.
(2) The staple cartridge of embodiment 1, wherein the solid central portion is configured to enhance sealing around the staples when the auxiliary material and the staples are combined with tissue.
(3) The staple cartridge according to embodiment 1, wherein the solid central portion of the auxiliary material is substantially rectangular.
(4) The staple cartridge according to embodiment 1, wherein the solid central portion includes first and second opposing edge portions.
(5) The staple cartridge according to embodiment 1, wherein the wing portion extends along the first and second opposing edge portions of the auxiliary material.

(6) The staple cartridge according to embodiment 1, wherein the wing portion is configured to disperse strain in the tissue outside the staple line when the auxiliary material is disposed on the tissue.
(7) The staple cartridge according to embodiment 1, wherein the wing portion includes round corners.
(8) The staple cartridge according to embodiment 1, wherein the wing portion has a mesh structure.
(9) The staple cartridge according to embodiment 1, wherein the wing portion has a plurality of openings formed therein.
10. The staple cartridge of embodiment 1, wherein the solid portion and wing portion are formed from a single polymer.

(11) The staple cartridge according to embodiment 1, wherein the wing portion is more flexible than the solid central portion of the auxiliary member.
(12) An end effector of a surgical instrument,
A first jaw and a second jaw, the first jaw having a cartridge body removably attached thereto, wherein the cartridge body is configured to place staples therein. A plurality of staple cavities, the second jaw having an anvil with a plurality of staple forming openings formed therein, and at least one of the first jaw and the second jaw; A first jaw and a second jaw that are movable relative to the other jaw;
A buttress having a width wider than at least one of the cartridge body and the anvil,
(I) a compressible central region configured to seal the periphery of the staple, and (ii) a strain relief region adjacent to the compressive region, wherein the strain relief region is formed in a plurality thereof. A buttress including a strain relief region, wherein the strain relief region extends from at least two sides of the central region.
The buttress is releasably retained on at least one of the cartridge body and the anvil, and when deploying staples from the cartridge body into the compressible region of the buttress, An end effector configured to be released from at least one of the anvils.
(13) The end effector according to embodiment 12, wherein the plurality of openings include slits.
14. The end effector of embodiment 13, wherein the plurality of slits extend parallel to the longitudinal axis of the staple when deploying the buttress and the staple in tissue.
(15) In the plurality of openings, the strain relief region is more flexible along a side portion of the strain relief region than a part of the strain relief region adjacent to the compressive region. Embodiment 13. The end effector of embodiment 12, wherein the end effector is spaced apart.

(16) A method for implanting a tissue reinforcing material on a tissue,
Tissue-engaging material for engaging tissue between a cartridge assembly and an anvil of a surgical stapler at a surgical site, wherein at least one of the cartridge assembly and the anvil is releasably retained thereon And the tissue reinforcing material has a compressible central region configured to seal around the staples and a flexible support defining a margin of the tissue reinforcing material adjacent to the central region Including territory,
Firing staples from the cartridge assembly by actuating the surgical stapler to form a staple line through the central region into the tissue to hold the tissue reinforcing material at the surgical site; Including a method.
Embodiment 17: Actuating the surgical stapler ejects the staple through the central region, but does not eject the staple through the flexible support region of the tissue reinforcing material. The method described in 1.
18. The embodiment of claim 16, further comprising wrapping the flexible support region around at least one of the cartridge assembly and the anvil and inserting the cartridge assembly and the anvil into the surgical site. Method.
The method of claim 16, wherein actuating the surgical stapler advances a cutting member through the tissue reinforcing material to release the tissue reinforcing material from the surgical stapler.
20. The method of embodiment 19, wherein actuating the surgical stapler advances the cutting member through the central region of the tissue reinforcing material.

Claims (7)

A staple cartridge for use with a surgical stapler,
A cartridge body having a plurality of staple cavities configured to place staples therein;
Auxiliary material that fits into the cartridge body and is configured to be removed from the cartridge body when the staple is deployed from the cartridge body into tissue, wherein the auxiliary material is substantially attached to the cartridge body. includes a central portion of the solid in which is sized and shaped so as matching, and a wing portion extending along at least two sides of the central portion of said solid, as a result, the wing portion, said extends beyond the lateral boundary of the cartridge body in a direction transverse to the longitudinal axis of the cartridge body, Bei example an auxiliary material, a
The wing portion has a mesh structure, so that the wing portion is more flexible than the solid central portion of the auxiliary material, and when the auxiliary material is disposed on the tissue A staple cartridge configured to disperse strain in tissue outside the staple line . The central portion of said solid, the auxiliary material and the staples when binding to tissue, are configured to enhance the sealing of the periphery of the staple, the staple cartridge according to claim 1. The staple cartridge of claim 1, wherein the solid central portion of the auxiliary material is substantially rectangular. The staple cartridge of claim 1, wherein the solid central portion includes first and second opposing edges. The staple cartridge according to claim 4 , wherein the wing portion extends along the first and second opposing edges of the auxiliary material.   The staple cartridge of claim 1, wherein the wing portion includes rounded corners. The solid central portion and the wing portion is formed from a single polymer, staple cartridge according to claim 1.

Images