JP6672182B2 - Method and apparatus for sealing stapled tissue - Google Patents

Description

  The subject matter disclosed herein relates to a method and apparatus for reinforcing a staple line.

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

  Most staplers have a handle with an elongated, flexible or rigid shaft, with a pair of opposing jaws formed at the end of the shaft for holding and shaping the staples. At least one of the opposing jaws is movable with respect to the other jaw. In the case of laparoscopic surgery, one jaw is often fixed and the other is movable. In some devices (eg, open linear staplers), opposing jaws are separated by an operator and can be re-applied, providing the relative movement required for tissue placement. The staples are typically contained in a staple cartridge, which can accommodate multiple rows of staples, and which is disposed in one of two jaws for release of staples to a surgical site. Often done. In use, the jaws are positioned so that the object to be stapled is positioned 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 that is configured to move between rows of staples in a staple cartridge and to longitudinally dissect stapled tissue between the stapled rows. The arrangement of the device, operation of the components or systems of the device, and other operations of the device, such as articulation, firing, can be accomplished in a variety of ways, such as electromechanically, mechanically, or hydraulically.

  Although surgical staplers have been improved over the years, many problems can arise. Rarely, as shown in FIG. 1, one problem is that when the staple S penetrates the tissue T or other object on which the staple S is to be placed, the staple S forms a tear and thus leaks. It can happen. Blood, air, gastrointestinal fluids, and other bodily fluids may ooze through the breach H formed by the staple S, even after the staple S has been completely formed. The tissue T to be treated may become inflamed due to manipulations and deformations that may occur during stapling. In addition, staples and other objects and materials implanted during a stapling procedure generally lack the same properties as the tissue in which they are implanted. For example, staples and other objects and materials may lack the natural flexibility of the tissue in which they are implanted. 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 have been placed therein.

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

  A method is provided for embedding a tissue strengthening material on tissue. The method may include 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 has a tissue-reinforcing material retained thereon. The tissue reinforcing material includes a central region configured to provide a seal around a staple penetration site (eg, in tissue, a central region, etc.), and an exterior defining an edge of the tissue reinforcing material adjacent the central region. Region. By activating the surgical stapler, staples can be ejected from the cartridge assembly to form a staple line through the central region and into the tissue to hold the tissue reinforcing material at the surgical site. Delivering the sealant to the tissue reinforcing material after actuating the surgical stapler when the sealant is in a first liquid state such that it solidifies on the tissue reinforcing material and enhances the sealing of the tissue on the staple line. Can be.

  This method can be varied in any number of ways. In certain embodiments, activating the surgical stapler causes the staple to be ejected through a central region of the tissue-reinforcing material. The method may further include wrapping the outer region of the tissue reinforcing material around at least one of the cartridge assembly and the anvil and inserting the cartridge assembly and the anvil into a surgical site. Activating the surgical stapler may release the tissue reinforcing material from the surgical stapler. In certain aspects, the surgical stapler advances the cutting member through a central region of the tissue reinforcing material. In other aspects, the surgical stapler forms a staple line having at least two rows of staples.

  The sealant can be delivered to the tissue in various ways. In certain embodiments, the sealant is delivered via an applicator tool positioned adjacent to the tissue reinforcing material. Delivering the sealant may include depositing the sealant on both the central and outer regions of the reinforcement material. In certain embodiments, the sealant is delivered to the tissue-reinforcing material in a first liquid state, whereupon the sealant penetrates into the space within the tissue on the staple line and solidifies therein.

  Further, a system is provided for enhancing tissue sealing. The system may include a sealant, a container, and an applicator tool. The sealant may be configured to transition from a first liquid state to a second solid state. The container is configurable to retain the sealant therein when the sealant is in a first liquid state, the container having a first port for receiving a gas and a second port for discharging the atomized sealant. It has two ports. An applicator tool is connectable to the second port of the container, and the applicator tool is configured to deliver an atomized sealant to the surgical site.

  This system can be varied in any number of ways. In certain aspects, the applicator tool is a trocar. In other aspects, the gas comprises carbon dioxide. In other aspects, the sealant comprises a mixture of collagen, fibrinogen, and thrombin. These biomaterials may be derived from human and / or animal sources. The sealant can be configured to transition from a first liquid state to a second solid state after a predetermined time has elapsed. The system may include additional components. For example, a first tube may extend between a second port of the container and the applicator to receive an atomized sealant.

  Further provided is a method for delivering a sealant to a patient's body. The method may include transitioning the sealant from a first liquid state to a second atomized state by delivering a gas to a container having the sealant therein. The nebulized sealant is deliverable via an applicator tool extending through the patient's access port, where the nebulized sealant solidifies on the tissue to form a seal thereon.

  The method can be implemented in various ways. For example, the applicator tool may be positioned within the patient's thoracic cavity before delivering the gas to the container. In certain embodiments, the applicator tool comprises a trocar and the atomized sealant is delivered directly into the patient via the trocar. The method may include positioning the distal end of the applicator tool adjacent to a staple line in the tissue prior to delivering the atomized sealant to the tissue. In certain embodiments, the cured sealant is absorbed by the body after a predetermined period of time.

The invention will be more completely understood in consideration of the following detailed description in conjunction with the accompanying drawings.
FIG. 4 is a side view of damaged, stapled tissue. FIG. 9 is a perspective view of one embodiment of an ancillary material described herein secured to stapled tissue. 1 is a perspective view of a prior art surgical instrument that can be used with one or more auxiliary materials. FIG. 4 is an exploded perspective view of the end effector and the distal end of the shaft of the device of FIG. 3. FIG. 4 is a perspective view of the E-beam component of the device 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. FIG. 5 is a perspective view of the end effector of FIG. 4. 1 is a side view of a prior art end effector having a staple cartridge implantable therein. FIG. 2 is a side view of a staple of the related art. It is sectional drawing of the end effector of 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. FIG. 2 is a plan view of a staple cartridge of the related art having a staple pattern. It is a side view of the end effector provided with the staple cartridge in which the auxiliary material was mounted. FIG. 5 is a side sectional view of the end effector of FIG. 4 having an auxiliary material thereon. FIG. 7 is a perspective view of an auxiliary having a central portion and a wing portion, the auxiliary being coupled to the cartridge assembly. FIG. 3 is a perspective view of an auxiliary stapled to tissue. FIG. 9 is a perspective view of another exemplary embodiment of an auxiliary stapled to tissue. FIG. 9 is a perspective view of an auxiliary material having a marginal protrusion configured to distribute strain to tissue outside the staple line. FIG. 9 is a perspective view of another auxiliary having a marginal protrusion, wherein the auxiliary is stapled to tissue. FIG. 4 is a perspective view of an auxiliary member including an outer region having a plurality of cuts formed therein. FIG. 11 is a side view of an auxiliary material having a modified outer region. FIG. 11 is a side view of an auxiliary material having a modified outer region. FIG. 11 is a side view of an auxiliary material having a modified outer region. FIG. 4 is a side cross-sectional view of an auxiliary member stapled to a body cavity. FIG. 3 is a perspective view of a first layer, a second layer, and an auxiliary material having a non-traumatic margin made of fabric. FIG. 22B is a side view of the auxiliary material of FIG. 22A showing a first layer and a second layer. FIG. 22B is a side view of the auxiliary material of FIG. 22A absorbing fluid between the first and second layers. It is a perspective view of the auxiliary material which has a thickness which fluctuates in a side surface direction. FIG. 11 is an end view of the anvil and cartridge assembly and two thickness varying auxiliary portions, a first auxiliary member associated with the anvil and a second auxiliary member associated with the cartridge assembly. FIG. 23B is an end view of the anvil and cartridge assembly of FIG. 23B with the first and second auxiliaries combined. FIG. 5 is a side view of a first auxiliary and a second auxiliary stapled to tissue. FIG. 3 is a side view of an auxiliary material having surface features formed thereon for penetrating and gripping tissue. FIG. 9 is a side view of another aid having surface features for penetrating and gripping tissue. FIG. 5 is an end view of four rows of auxiliary materials, each row having auxiliary surface features secured in tissue. FIG. 4 is a side view of an auxiliary material having a surface mechanism penetrating tissue. FIG. 9 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 aid of FIG. 24A having pointed surface features that penetrate tissue. FIG. 9 is a perspective view of a cartridge assembly having an aid for removably coupling to a distal end of the cartridge assembly. FIG. 26B is a side view of the cartridge assembly and anvil of the surgical stapler gripping tissue, with the aid of FIG. 26A extending beyond the distal end of the cartridge assembly. FIG. 27C is a side view of the cartridge assembly and anvil of FIG. 26B deploying staples through the aid and tissue. FIG. 14 is a perspective view of an auxiliary member having a protrusion configured to mate with a corresponding recess formed in the cartridge assembly. FIG. 9 is a perspective view of an auxiliary member having a single protrusion configured to mate with a corresponding recess formed in the cartridge assembly. FIG. 11 is an end view of an auxiliary member extending around the 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 accessory and cartridge assembly of FIG. 27A with a cutting member advanced through the cartridge assembly to release the accessory from the cartridge assembly. FIG. 14 is a perspective view of the cartridge assembly including a suture connecting the auxiliary material and the cartridge assembly. FIG. 29B is a perspective view of the cartridge assembly and auxiliary of FIG. 29A with the suture removed from the cartridge assembly to release the auxiliary. FIG. 4 is a perspective view of a shaft of a surgical stapler with an auxiliary material attached thereto. FIG. 30B is a side view of the shaft of FIG. 30A showing attachment points for attaching an auxiliary material to the shaft. FIG. 4 is a perspective view of a driver insertable into a shaft and having 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 cutting member of the stapler in a first retracted position. FIG. 30B is a partial plan view of the shaft of FIG. 30A with the cutting member in a second advanced position releasing the auxiliary material from the shaft. FIG. 4 is an end view of the cartridge assembly, the auxiliary material, and an insertion tool for attaching the auxiliary material to the cartridge assembly. 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 auxiliaries have been installed and the insertion tool has been removed from the cartridge assembly. 1 is an exemplary kit including a retaining tool and a surgical stapler, wherein the retaining tool is configured to wrap an aid around the cartridge assembly / anvil. FIG. 32B is a side view of the holding 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, with the holding tool in the most proximal position. FIG. 7 is a perspective view of the stapler end effector with the aids coupled and positioned above the trocar. FIG. 33C is a perspective view of the end effector of FIG. 33A with an auxiliary wrapped around the end effector when inserting the end effector into the trocar. FIG. 4 is an end view of the cartridge assembly and anvil of the surgical stapler with the multi-layered aid attached. FIG. 6 is a side view of three auxiliary portions stapled to tissue and having a polymerized portion therebetween. FIG. 5 is a perspective view of a first auxiliary material and a second auxiliary material stapled to tissue and having a first overlap portion and a second overlap portion. FIG. 2 is a perspective view of a first and second auxiliary material stapled to tissue and having a sealant delivered to an outer surface of the first auxiliary portion. FIG. 35B is a side view of the first and second auxiliaries of FIG. 35A stapled to tissue. FIG. 35B is a side view of the first and second auxiliaries of FIG. 35A having a sealant delivered to a space below the outer surface of the auxiliaries. FIG. 35B is a side view of the first and second auxiliary members of FIG. 35A in an expanded position. 1 is a perspective view of a system for nebulizing a sealant, including a container and an applicator tool extending through a trocar and into a patient. FIG. 36B is a perspective view of the applicator tool of FIG. 36A delivering the sealant to the staple lines of the tissue. FIG. 36B is a perspective view of the atomized sealant of FIG. 36A cured on a staple line. FIG. 4 is a perspective view of another exemplary system for nebulizing a sealant and delivering the nebulized sealant to a patient directly into a patient via a trocar. FIG. 37B is a perspective view of the trocar of FIG. 37A delivering an atomized sealant to tissue on the staple line and tissue off the staple line.

  Certain exemplary embodiments will now be described to provide an overall understanding of the principles of structure, function, manufacture and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will recognize that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of such devices and methods are: It will be understood that they are defined only by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the devices and methods described herein. Further, in the present disclosure, like-numbered components of various embodiments have generally similar features if the components serve similar properties and / or similar purposes.

  Throughout this specification, reference to "a variety of embodiments," "some embodiments," "one embodiment," or "an embodiment," etc. A feature, structure, or characteristic is meant to be included in at least one embodiment. Thus, appearances of the phrases "in various embodiments", "in some embodiments", "in one embodiment", or "in one embodiment" in various places throughout this specification. , These do not necessarily all refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular feature, structure, or characteristic illustrated or described in connection with one embodiment, without limitation, in whole or in part, may be a feature of one or more other embodiments. , Structure, or characteristics. Such modifications and variations are intended to be included within the scope of the methods, apparatus, devices, and systems described herein.

  The terms "proximal" and "distal" are used herein with reference to a clinician operating the handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician, and the term "distal" refers to the portion located away from the clinician. It is further understood that for convenience and clarity, spatial terms such as "vertical", "horizontal", "above", and "below" may be used herein with respect to the drawings. Would. 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 "auxiliary materials", with surgical instruments to assist in improving a surgical procedure. possible. These biomaterials may be derived from human and / or animal sources. One skilled in the art may refer to these types of materials as buttress material or auxiliary material.

  Various exemplary devices and methods are provided for performing a surgical procedure. 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 fired directly by a human user or under the direct control of a robot or similar operating tool. However, one skilled in the art will appreciate that the various methods and devices disclosed herein may be used in a number of surgical procedures and applications. Various instruments disclosed herein may be inserted into the body in any manner, such as through a natural orifice, through an incision or puncture made in tissue, or 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 operative or end effector portion of these instruments can be inserted directly into the patient's body, or an access device having a working channel through which the end effector and elongate shaft of the surgical instrument can be advanced. Can be inserted through

  As described herein, an end effector of a surgical instrument delivers one or more synthetic and / or biological materials, collectively referred to herein as "auxiliary materials," to a surgical site. As such, it may 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 auxiliaries, and in some exemplary embodiments, the end effector may be a surgical stapler. When used with a surgical stapler, the auxiliary material may be located between and / or over the staple jaws, incorporated into a staple cartridge located on the jaws, or otherwise, the It may be located proximally. Once the staples have been deployed, the auxiliary material may remain with the staples at the treatment site, thereby providing a number of benefits. In some cases, auxiliary materials may be used to help seal the holes formed by the staples as they are implanted in tissue, blood vessels, and various other objects and body parts; and / or Alternatively, it can be used to provide tissue augmentation at the treatment site. Tissue augmentation prevents staples from tearing tissue when it is healing from a diseased tissue, another treatment such as radiation therapy, a drug therapy such as chemotherapy, or other circumstances that alter tissue properties. There is something you need to do. In some cases, the adjunct may minimize movement of tissue within and near the staple puncture site, which may result from tissue deformation (eg, lung distension, gastrointestinal distension, etc.) that occurs after stapling. One skilled in the art will recognize that the staple puncture site may be a stress concentrator, and the size of the hole formed by the staple will increase as the surrounding tissue is placed under tension. Restricting tissue movement near these puncture sites can minimize the size of the hole 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 adjunct may be configured to degrade 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 fluids) ( For example, human or animal derived fibrinogen and thrombin can be lyophilized into a powder that upon mixing with water provides a sealant). Still further, adjuvants can help reduce inflammation, promote cell growth, or otherwise improve healing.

  FIG. 2 illustrates one embodiment of an aid that includes a perforated buttress 30 that can be secured to tissue T to be treated by a surgical stapler and that remains with the staple 70 at the treatment site. The buttress 30 may be made of one or more absorbent materials and may be stamped, squeezed, cut, molded, woven, melted, blown, made of composite structures and / or methods, or otherwise. The method can be shaped to facilitate absorption, enhancement, delivery, and / or retention of beneficial fluids such as sealants, adhesives, blood, and the like. 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 a distal end 12d of the handle assembly 12, and an end effector 50 at a distal end 14d of the shaft 14. Because the embodiment shown is a surgical stapler, end effector 50 has jaws 52, 54, but other types of end effectors are used with shaft 14, handle assembly 12, and their associated components. obtain. The surgical stapler 10 includes opposing lower and upper jaws 52, 54, the lower jaw 52 includes a staple channel 56 (FIG. 4) configured to support a staple cartridge 60, and the upper jaw 54 includes Opposed to lower jaw 52, it has an inner surface 58 configured to operate as an anvil to assist in staple deployment of 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 provide at least a portion of the end effector 50. It can be configured to pass through and release staples into the clamped tissue. In various embodiments, the knife blade 81 can be connected to a firing system to cut tissue during a stapling procedure. At least one of the opposing lower and upper jaws 52, 54 is movable with respect 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 opposing lower and upper jaws 52, 54 are movable.

  Activation of end effector 50 may be initiated by input from a clinician at handle assembly 12. Handle assembly 12 may have many different configurations designed to handle and operate end effector 50 coupled thereto. In the illustrated embodiment, handle assembly 12 has a pistol-type housing 18 having various mechanical and / or electrical components disposed therein to operate various functions of the instrument. For example, handle assembly 12 may be mounted adjacent its distal end 12d, which may facilitate rotation of shaft 14 and / or end effector 50 about longitudinal axis L of shaft 14 relative to handle assembly 12. A rotating knob 26. Handle assembly 12 may further include a clamping component as part of a clamping system activated by clamp trigger 22 and a firing component as part of a firing system activated by firing trigger 24. The clamp and firing triggers 22, 24 may be biased to an 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 activate a clamping system described below, which can cause the jaws 52, 54 to tilt toward each other, thereby clamping tissue therebetween. Movement of the firing trigger 24 may activate the firing system described below, thereby discharging staples from a staple cartridge disposed therein and / or advancing the knife blade 81 to move the jaws 52, The tissue captured during 54 may be cut. One of ordinary skill in the art will be aware of various configurations of mechanical, hydraulic, pneumatic, electromechanical, robotic, or other launch system components that may be used to release staples and / or dissect tissue, and thus No detailed description is required.

  As shown in more detail in FIG. 4, the end effector 50 of the illustrated embodiment includes 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 a staple tray 57, which in turn is supported in a cartridge channel of the lower jaw 52. Upper jaw 54 has a plurality of staple forming pockets 66 (FIG. 11), each pocket being 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 54p that is pivotally received within a proximal end 56p of the staple channel 56, just distal to its engagement with the shaft 14. , Upper jaw 54 may be connected to lower jaw 52 in a variety of 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 may be used to effect the opening and closing of the jaws 52, 54 to selectively clamp tissue therebetween. In the illustrated embodiment, the pivot end 54p of the upper jaw 54 includes a closure mechanism 54c distal to the pivot attachment with the staple channel 56. Thus, the closure tube 82, which includes a horseshoe-shaped opening 82 a whose distal end engages with the closure mechanism 54 c, responds to the clamp trigger 22 with respect to the upper jaw 54 during proximal longitudinal movement of the closure tube 82. To selectively apply a closing movement to the upper jaw 54 during the distal longitudinal movement of the closing tube 82. One skilled in the art will appreciate that the opening and closing of the end effector 50 may be effected by the relative movement of the lower jaw 52 relative to the upper jaw 54, the relative movement of the upper jaw 54 relative to the lower jaw 52, or the 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 a distal end, as shown in FIG. The firing bar 84 is contained within the shaft 14, for example, within the longitudinal firing bar slot 14 of the shaft 14 and is guided by a firing motion from the handle 12. Activation of firing trigger 24 may affect distal movement of E-beam 86 through at least a portion of end effector 50, thereby firing staple 70 contained within staple cartridge 60. In the illustrated embodiment, a guide 85 protruding from the distal end of the E-beam 86 may engage a wedge sled 90, which in turn engages a staple cavity 68 formed in the staple cartridge 60. The staple driver 92 can be pushed up. 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 pressing against the anvil surface 58 of the upper jaw 54 to push up the staples 70 and to release the formed staples 70 '. Form.

  E-beam 86 facilitates closing jaws 52, 54, pulling upper jaw 54 away from staple cartridge 60, and / or cutting tissue trapped between jaws 52, 54, in addition to firing staples. It 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 such that the firing bar 84 advances when the firing bar 84 advances through the end effector 50. 52, 54 may be squeezed toward each other. At the same time, knife 81 extending between top pin 87 and bottom pin 89 can be configured to cut tissue captured between jaws 52,54.

  In use, the surgical stapler 10 may be placed in a cannula or port and placed at a surgical site. The dissected and stapled tissue may be placed between the jaws 52, 54 of the surgical stapler 10. The mechanism of the stapler 10 may be operated as desired by the clinician to achieve the desired position of the jaws 52, 54 at the surgical site and tissue with respect to the jaws 52, 54. After achieving proper positioning, the clamp trigger 22 may be pulled toward the stationary handle 20 to activate the clamping system. The trigger 22 causes the closure tube 82 to advance distally through at least a portion of the shaft 14 to deflect at least one of the jaws 52, 54 toward the other and clamp tissue disposed therebetween. To operate the components of the clamping system. Thereafter, firing bar 84 and / or E-beam 86 may be advanced distally through at least a portion of end effector 50 to cause firing of staple 70 and, optionally, capture between jaws 52, 54. The trigger 24 may be pulled toward the stationary handle 20 to activate the firing system components to cut the cut tissue.

  Another embodiment of the surgical instrument 100 is shown in FIG. Like the surgical instrument 10, the surgical instrument 100 includes a handle assembly 112 with 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 therebetween, stapling the tissue by firing staples from a cartridge 160 disposed on the lower jaw 154, and / or dissecting the tissue. It can be configured to form a part. 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 part 116 can be fitted with the auxiliary fitting mechanism 123 of the handle assembly 112. While any number of auxiliary mating mechanisms and any type of coupling may be used to removably couple shaft 114 to handle assembly 112, mating mechanisms 123, 125 may include, for example, snap-fit couplings, bayonet couplings. And the like. Although the entire shaft 114 of the illustrated embodiment may be configured to be removable from the handle assembly 112, in some embodiments, the mounting portion 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.

  Handle assembly 112 can have one or more features thereon to handle and operate 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 the end effector 150 relative to the handle assembly 112. Handle assembly 112 may further include a clamping component as part of a clamping system activated by trigger 122 and a firing component as part of a firing system that may also be activated by trigger 122. Thus, in some embodiments, movement of the trigger 122 toward the stationary handle 120 through the first range of motion actuates the clamping component to move the opposing jaws 152, 154 toward one another to approach the closed position. I can make it. Further movement of the trigger 122 toward the stationary handle 120 through the second range of motion can actuate the firing component to eject staples from the staple cartridge 160 and / or advance the knife to cause the jaws 152 to move. 154 may cause the tissue captured to be severed.

  Yet another embodiment of a surgical instrument 200 is shown in FIG. Like the surgical instruments 10 and 100, the surgical instrument 200 includes a handle assembly 212 with a distally extending shaft 214 having an end effector 250 at a distal end for treating tissue. 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 actuation of the actuator 222 on the handle assembly 220 causes the shaft 262 to retract and move relative to the cartridge assembly 252. To move the anvil 254. In one embodiment, the shaft 262 is releasably coupled to each other so that the anvil 254 can be removed from the cartridge assembly 252, and is configured to allow for more flexible positioning of the anvil 254 and the cartridge assembly 252 within the body. It is formed from a first part and a second part (not shown). For example, a first portion of the shaft may be disposed within cartridge assembly 252, extend distally outside cartridge assembly 252, and terminate within a distal mating mechanism. A second portion of shaft 214 is disposed within anvil 254 and extends proximally outside cartridge assembly 252 and may terminate within a proximal mating mechanism. In use, the proximal and distal mating mechanisms may combine to allow the anvil 254 and the cartridge assembly 252 to move relative to each other. Anvil 254 and cartridge assembly 252 can perform a variety of functions, and can be configured to capture tissue therebetween, fire staples from cartridge assembly 252 to stap the tissue, and / or dissect tissue. A part can be formed. In general, the cartridge assembly 252 can house a cartridge containing staples and can deploy the staples against the anvil 254 to form a circular pattern of staples around the tubular body organ.

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

  The illustrated embodiments of the surgical stapling instruments 10, 100, and 200 provide examples of only a few of many different configurations and associated uses, 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 US Pat. No. 8,317,070, for example, instruments configured for use in open surgical procedures. It will be understood that any open linear stapler that can be used with the disclosure provided herein. Additional details regarding the illustrated embodiments, as well as additional exemplary embodiments of surgical staplers, components thereof, and methods of use associated therewith that may be used in accordance with the present disclosure are provided in US Patent Application Publication No. 2013/0256377, U.S. Patent Nos. 8,393,514, 8,317,070, 7,143,925, and U.S. Patent Application No. 14 / 074,884, entitled "Sealing Materials for Use in Surgical Procedures," No. 14 / 074,810 (filed on Nov. 8, 2013) and No. 14 / 074,810 (filed on Nov. 8, 2013), entitled "Hybrid Adjunct Materials for Use in Surgical Stapling". "Pos No. 14 / 075,459, entitled "Tissue Independent Materials on and on the 13th of the first month of the next month, filed on November 8, 2013,", which entitled "Tivile Charged Implantable Materials and Method of the forming the Same", filed on November 8, 2013. No. 14 / 074,902, entitled "Hybrid Adjunct Materials for Use in Surgical Stapling", filed on November 8, 2013, and No. 14 / 226,142, entitled "Surgical Instrument Trading Company , 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 instruments described herein may have one or more mechanisms for adjusting the amount of compression applied by the end effector 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 tissue being treated) in the tissue captured within the end effector. It can be configured to create. As a non-limiting example, the desired tissue compression profile uses the deformation of the gap between the upper and lower jaws of the end effector and / or the deformation, orientation, size, and / or shape of the staples applied to tissue by the end effector. Can be obtained. As described in detail herein, the aids used with such an end effector assist in creating a desired tissue compression profile and / or mechanisms used to create a desired tissue compression profile. Can be configured to correspond to

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

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

  In some embodiments, one or more aids secured to the end effector of the 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 described herein, and can include an end effector (eg, It can be configured to be mounted in the end effector 350). 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 manner, when the upper jaw 354 of the end effector 350 is in the closed position in close proximity to the cartridge 360, the upper jaw 354 of the end effector 350 moves the distal end 360d more as compared to the proximal end 360p. It can be configured to compress. The compression gradient created in the tissue captured by the cartridge 360 decreases linearly from the distal end 360d to the proximal end 360p, but one skilled in the art will appreciate that the various shapes of the cartridge 360 allow for any compression. It will be appreciated that a gradient may 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 contained within the staple cartridge of the end effector can be configured to create a desired compression profile in the tissue captured by the staples. For example, where the staples in the staple cartridge have different unformed staple heights, a desired compression profile can be created in the stapled tissue. 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 top or top 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 as compared to the second staple height H2 of the second staple group 370b. May be provided. First staple group 370a can be positioned on a first portion (eg, an outer portion) of staple cartridge 360, and second staple group 370b can be positioned on a second portion (eg, an inner portion) of 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 a cutting instrument (eg, E-beam 86) therethrough. One skilled in the art will appreciate that the first staples 370a and the second staples 370b may be arranged in any pattern and may be laterally and / or longitudinally spaced along the cartridge 360. It will be understood. In certain embodiments, multiple staple groups 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 located in the cartridge halfway between the first group of staples and the second group of staples. In various embodiments, each staple in a staple row in a staple cartridge may include a different staple height. In at least one embodiment, the tallest staple in the staple row may be located at a first end of the staple row, and the shortest staple may be located at an opposite end of the staple row. is there. In at least one such embodiment, a staple located intermediate the highest staple and the shortest staple is configured, for example, such that the staple height decreases between the highest staple and the shortest staple. obtain.

  Similarly, the staples in the staple cartridge may have various crown widths to create a 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 other. As with the above variations in staple height H, variations in staple width W may also be spaced across the entire staple cartridge to create a plurality of staple groups distributed along the length and / or lateral direction of the cartridge. Can be. As a non-limiting example, FIG. 12 shows a staple cartridge 260 for use with a surgical instrument 200 having staples 270 having various crown widths W therein. The staple cartridge 260 contains three groups of staples 270a, 270b, 270c having different widths W1, W2, and W3, respectively, but any number of staple groups are possible. As shown, the staple groups 270a, 270b, 270c can be arranged in a circumferential array, the staples 270c having a maximum width W1 positioned at the outermost edge of the cartridge 260, and the staples 270a Has the smallest width W3 positioned at the innermost peripheral edge of. In other embodiments, a larger crown width staple can be positioned near the innermost edge of the cartridge and a smaller crown width staple can be positioned near the outer edge of the cartridge. Can be. In still further embodiments, staples along the same row can have different crown widths.

  Additionally or alternatively, it may be possible to create a desired tissue compression profile by creating various (final) staple heights after formation. FIG. 13 illustrates a cutting line 494 that has been placed using a surgical stapling instrument as described herein and that applies staples 470 ′ having various post-formation heights and cuts tissue. 9 illustrates an exemplary embodiment of a plurality of lines of a formed staple 470 'configured to create a staple 470'. As shown in FIG. 13, the post-formation height F1 of the first row of first staple groups 470a ′ located at the farthest distance from the cutting line 494 is the third height in the third row closest to the cutting line 494. Is larger than the height F3 after the formation of the staple group 470c ′. The second group of staples 470b 'in the second row formed between the first and third rows includes staples 470b' having a formed height F2 that is intermediate between the heights F1 and F3. I can do it. In other embodiments, the height after staple formation may decrease from the innermost row to the outermost row. In still further embodiments, the post-formation height of the 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 formation distance A. The forming distances A1, A2 can be measured from the base of the staples 370a, 370b in the cartridge 360 when the upper jaw 354 is in the closed position, to the tip of the corresponding forming pocket 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 staples 370a are not pressed as much as the staples 370b, so that the heights of the staples 370a and 370b after formation can be changed. In particular, a larger amount of compression corresponding to a smaller forming distance may result in a smaller staple of post-forming (final) height. 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 pattern in the staple cartridge (eg, by the patterns shown in FIGS. 14 and 15). In the embodiment shown in FIG. 14, staple cartridge 560 may include at least one first staple cavity 568a and at least one second staple cavity 568b for receiving staples 570 therein. The first cavity 568a can be located on a first outer portion 563 of the cartridge 560, and the second cavity 568b can be located on a second outer portion 565 of the cartridge 560, and the first and second The two sides 563, 565 are separated by a cutting instrument, for example, a slot 567 configured to receive an E-beam 86 therethrough. First cavity 568a can define a first longitudinal axis 569a, and second cavity 568b can define a second longitudinal axis 569b. In the exemplary embodiment, the first axis 569a is perpendicular or substantially perpendicular to the second axis 569b. In other embodiments, the first axis 569a may intersect the second axis 569b such that the axes 569a, 569b may make 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 some of the staple cavities 568a, 568b may overlap so that the staples 570 therein can be interconnected during formation. The cartridge 560 may be provided on the first side 563 and the second side 565 of the cartridge 560 in any pattern (eg, the longitudinal axis of the cartridge 560 extending along both sides 563, 565 of the cartridge 560). Lc), each of which may have a plurality of first cavities 568a and a plurality of second cavities 568b. Staples 570 contained within cavities 568a, 568b can be embedded in 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 staple 570 orientations on either side of an 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 668a and 668b having different orientations may be located on a single outer portion 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 arranged on each of the side 663 and the second side 665. In other embodiments, axes 669a, 669b may form an acute or obtuse angle therebetween, or may be parallel to one another. A plurality of first cavities 668a and second cavities 668b are provided in adjacent rows along the longitudinal axis Lc ′ of the cartridge 660 on each of the first side 663 and the second side 665 of the cartridge 660. Can be aligned. In this embodiment, the staples 670 contained within the cavities 668a, 668b can be implanted into the tissue in a symmetric pattern about the incision made by the surgical instrument carrying the cartridge 660. Further details of staple patterns, and further embodiments of such patterns, can be found in U.S. Patent Application Publication No. 2011/0192882, 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 relates to implantable materials such as, for example, synthetic and / or biomaterials (collectively "auxiliary materials"), in conjunction with the method of operating the instrument. Provides usage 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, the auxiliary material 30 comprising a staple channel 56 and / or an anvil surface. It may be releasably held in one of the 58. In use, the aid 30 and patient tissue may be captured by the staple 70 when the staple 70 is fired. Subsequently, the auxiliary material 30 can be separated from the surgical stapler and can remain in the patient when the stapler is removed from the patient. Exemplary devices and methods for attaching one or more auxiliaries to an end effector of a surgical instrument are described in U.S. Patent Application Publication Nos. 2013/0256377 and 1993, which are incorporated herein by reference in their entirety. 2013/0155361.

  The auxiliaries used with the disclosure provided herein may have any number of configurations and properties. Generally, the adjunct is broken, for example, bioabsorbable, biodegradable, and / or otherwise, such that the adjunct is absorbed, dissolved, degraded, and / or destroyed during the healing process. It can be made of materials that can be used. In at least one embodiment, the adjunct can be configured to degrade over time to form a gel, eg, a sealant, to aid wound healing. In other embodiments, the adjunct can include, for example, a therapeutic agent that is released over time and can be configured to assist in treating the tissue. In further various embodiments, the auxiliary material may include, for example, a non-absorbable and / or non-breakable material.

  Some particularly beneficial auxiliaries can include, for example, a porous polymer scaffold that can be configured to be destroyed by exposing the water to water to attack the polymer bonds of the material. The degraded adjunct can be configured to gel on the wound site, thereby covering the wound tissue, eg, wound soft tissue, which can compress, seal, and / or generally remove tissue at the wound site. It can help create an environment that promotes healing. Specifically, such degradable polymers may allow the tissue itself to become a load-bearing component. In some embodiments, the degraded adjunct can 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 almost immediately after attachment. For further details on porous polymer scaffolds as described herein, see Q. A., 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 crosslinked, which allows the polymer to have any desired porosity, surface area to volume ratio, and mechanical properties. It can be formed into a complex three-dimensional shape having, for example, 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 / lyophilization, and the like. When the scaffold is formed into a film or sheet, the film or sheet can have any desired thickness, for example, about 50-750 μm or about 1-3 mm, depending on the desired application.

  One embodiment of a porous polymer scaffold includes multiple layers, each of which may perform a different wound healing function. In an exemplary embodiment, the caffold 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 (PEEUU), and the third layer is poly (carbonate urethane) urea (PCUU) lysine triisocyanate (LTI) or hexamethylene diisocyanate (HDI). Those 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 may be achieved by blending or copolymerizing the material of the third layer, or by copolymerizing with various polymers or copolymers. By way of non-limiting example, the material of the third layer may be 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 If the material of the third layer is blended with the polyester copolymer and PEG, the ratio of polyester to PEG in the third layer can be about 50:50. In another exemplary embodiment, PCL may be present in a range of about 60-70% weight / volume, PGA may be present in a range of about 20-30% weight / volume, and PEG may be present in about 50% weight / volume. And PDLLA may be present in a range of about 10% weight / volume.

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

  Another exemplary embodiment of a porous polymer scaffold may be synthesized from polyhydroxyalkanoate (PHA). In an exemplary embodiment, the PHA can be produced naturally from a variety of microorganisms, for example, Gram-negative or Gram-positive bacteria, or the manufacture of Biopol®, for example, available from Zeneca (London, United Kingdom). Can be synthesized in the same manner. 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, such as in the range of about 30 minutes to about 10 hours. PHA can be formed into very thin films, eg, films having a thickness of less than 0.1 mm, eg, 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 of PHA, or crystallinity and / or brittleness, such as hydroxvalerate (HV), hydroxybutyrate (HB), and / or hydroxyhexylate. It can be copolymerized with hydroxyhexanoate (HH). In other embodiments, the PHA can be blended with one or more thermoplastics, such as poly (lactic acid) (PLA), PGA, PCL, starch, etc., whereby the molecular weight of the scaffold and the result 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 may be synthesized from poly (polyol sebacic acid) (PPS), for example, from poly (glycerol sebacic acid) (PGS). Such scaffolds may be particularly biocompatible and, in addition to promoting healing, may provide the additional benefit of reducing the risk of infection. Other exemplary embodiments can be synthesized from xylitol-based elastomers, such as polyxylitol sebacic acid (PXS), which can provide structural stability over a clinically necessary period of time and / or blood glucose levels Can rapidly enter the metabolic pathway without rapidly fluctuating. Scaffolds made from PXS can be formed into thicker films, which can result in stronger compression at the wound site and can be configured to degrade within about 10 hours to 8 days after application. Yet another exemplary embodiment is a poly (glycerol sebacate-co-copolymer that can promote ingrowth of growing tissue into a scaffold and / or can function as an antimicrobial, especially when formed as fibers. -Acrylic acid) (PGSA). PGSA scaffolds may be useful as a replacement for conventional surgical sutures and staples and / or waterproof sealants used to fit luminal organs (eg, tubes, intestines, etc.), 2D mesh grafts (eg, , Hernias, ulcers, burns, etc.) and / or wound dressings (eg, hemostatic patches, etc.). PGSA can be combined with glycerol so that the scaffold can persist at that location for a longer period of time, for example, up to 20 days.

  In yet another embodiment, the scaffold can be blended with silk fibroin (SF) and made from poly (ε-caprolactone) (PCL) that can be formed into very thin films. PCL / SF blends may have very high biocompatibility properties and / or may enhance cell attachment and / or growth into scaffolds. For example, when implanted in tissue, the scaffold may release fibroin into the tissue, thereby promoting faster healing, almost immediate hemostasis, and / or attracting more fibroblasts. . The PCL component may further assist the healing process by providing mechanical compression of the wound tissue. A higher PCL content may result in better mechanical properties, while a higher SF content may result in better degradation properties. Broadly, the PCL content can range from about 50-90% weight / volume, and the SF content can range from about 10-50% weight / volume. Further details of the properties and manufacturing methods of scaffolds made of PCL and SF can be found in Jun Sik Lim et al., Incorporated herein by reference in its entirety. , Fabrication and Evaluation of Poly (epsilon-caprolactone) / Silk Fibroin Blend Nanofibrous Scaffold, Biopolymers 97: 265-275 (2012).

  In still further embodiments, the scaffold may include a gelatin-coated PCL. The scaffold may be disposed 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 from gelatin-coated PCLs are described in Pengcheng Zhao et al., "Biodegradable fibrous scaffolds composed of gelatine coated poly-epsilon (e.g., Pengcheng Zhao), which is hereby incorporated by reference in its entirety. prepared by coaxial electrospinning "J. Biomed Mater Res 83A: 372-382 (2007).

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

  Other suitable auxiliaries may include absorbent polyurethanes, such as those derived from aromatic absorbent isocyanates and chain extenders diols, which may be similar to methylene bis (phenyl isocyanate) (MDI). Absorbable polyurethanes can be configured to hydrolyze when hydrolyzed into safe and biocompatible products. 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, triesters of glycolic acid and trimethylpropane, and tetraesters of glycolic acid and pentaerythritol.

  Another particularly useful aid that can be used with the disclosure provided herein is the material that forms the multi-layer dressing disclosed in US Patent Application Publication No. 2006/0257458, which is incorporated herein in its entirety. Yes, they are particularly suitable for absorbing and retaining body fluids, for example, when squeezed by the application of staples. For example, as a buttress, other exemplary non-limiting examples of synthetic materials that can be used with the disclosure provided herein include polydioxanone films or polyglycerol sebacate sold under the trademark PDS® ( PGS (polyglycolic acid and its various forms sold under the trademark Vicryl, Dexon, and / or Neoveil), PCL (polycaprolactone), PLA or PLLA (PGS). Polylactic acid), PHA (polyhydroxyalkanoate), PGCL (polygrecapron 25 sold under the trademark Monocryl), PANACRYL (Ethicon, Inc. (Somerville, NJ)), polyglactin 910, polyglyconate, PGA TMC (polyglycolide-trimethylene carbonate sold under the trademark Biosyn), polyhydroxybutyric acid (PHB), poly (vinylpyrrolidone) (PVP), poly (vinyl alcohol) (PVA), polydioxanone (PDO) and various of these Form (eg, sold under the trademark PDS), or other biodegradable films formed from any of the above blends or copolymers. The blend and / or copolymerization of any of the above materials can be tailored to have the desired molecular weight and / or degradation rate.

  Some non-limiting examples of bio-derived materials that can be used, for example, as sealant materials with the disclosure provided herein include platelet poor plasma (PPP), platelet rich plasma (PRP), starch, chitosan, Alginate, fibrin, thrombin, polysaccharides, cellulose, collagen, bovine collagen, bovine pericardium, gelatin-resorcin-formalin adhesive, oxidized regenerated cellulose, regenerated cellulose, mussel adhesive, poly (amino acid), agarose, poly Ether ether ketone, amylose, hyaluronan, hyaluronic acid, whey protein, cellulose gum, starch, gelatin, silk, Davol Inc. (Progel® available from Warwick, Rhode Island), TachoSil® available from Baxter (Deerfield, Illinois), or will be apparent to those skilled in the art in view of the disclosure provided herein. Other materials that are suitable for mixing with a biological material and that are suitable for introduction into a wound site or a defect site, including any combination of materials or any material. Biomaterials can be derived from a number of sources, for example, patients into which the biomaterial is implanted, humans who are not the patients into which the biomaterial is implanted, and other animals.

  Additional disclosures regarding synthetic or polymeric materials and biomaterials that can be used with the disclosure provided herein can be found in US Patent No. 7,772,352, WO 2014/016819, US Patent Application Publication 2006. / 0257458, 2012/0080335, 2012/0083835, 2013/0256372, 2013/0256365, 2013/0256376, US Patent Application No. 13 / 710,931 ( The name is "Electrosurgical End Effector with Tissue Tracking Features", filed on December 11, 2012, and No. 13 / 763,192 (the 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 Part with Strain Relief Tissue Auxiliary Part can have a wide variety of configurations, but is generally configured to contact tissue when it is clamped between a surgical stapler cartridge assembly and an anvil. Be composed. One advantage of a tissue assist is the tendency to prevent or minimize leakage, such as leakage of bodily fluids or gases. The tissue assisting mechanism may include the following mechanisms: closing a hole or tear that occurs at the staple puncture site; limiting movement of tissue around the staple puncture site to prevent the staple hole from expanding in size; and / or Alternatively, this function may be achieved by one or more of preventing tissue rips, minimizing strain gradients between tissue constrained within the staple line and free tissue adjacent to the staple line. Can be performed.

  In certain embodiments, an adjunct can be used to distribute the compressive clamping force throughout the tissue, 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 auxiliaries may be located within the end effector.

  The tissue assist may include a wide variety of features and may 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 leaks in the tissue. Can be. For example, the tissue aid may have a central region configured to be deployed on tissue and attached to the tissue via staples. The tissue aid may further include an outer region (also referred to herein as a wing region or wing portion) that may be positioned outside the staple line when the aid is stapled to the tissue. The wing portions may help distribute the strain more evenly and / or minimize strain gradients when the tissue deforms or otherwise expands and contracts during normal bodily functions. 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 period of time. When the sealant is in the first liquid state, the sealant may penetrate into the adjunct and / or the staple line and subsequently harden therein to facilitate complete sealing of the tissue. In this way, the aid and sealant can cooperate to provide a better and more complete staple line seal than when only a tissue aid or sealant is used.

  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 therethrough, and a wing portion 1004 adjacent the central 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 matches in size and shape with the tissue contacting surface of the cartridge assembly 52. That is, the central region 1002 can be substantially equal in size to the tissue contacting surface. The central region 1002 of the auxiliary portion 1000 shown in FIG. 17A is substantially defined by a proximal margin 1002p and a distal margin 1002d, and a first lateral margin 1002a and a second lateral margin 1002b. May have an elongated rectangular shape. The proximal margin 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 extending therearound to form an 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 aid 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 exemplary embodiment, central region 1002 may be substantially solid, such as, for example, a film, and 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 therethrough, Wing portion 1004 can extend laterally away from staple 1008. As shown, the auxiliary portion 1000 stapled to the tissue T removes half of the auxiliary material shown in FIG. 17A because the cutting member of the stapler cuts the tissue while the staple 1008 is deployed thereon. Including. The mesh wing portion 1004 bends as the tissue expands and contracts, distributing strain more evenly over a larger area (or minimizing strain gradients) than when the auxiliary portion 1000 includes only the central region 1002. 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 repeated stretching and contraction of the tissue. In certain aspects, the mesh can be formed from threads of the same film material as the central region 1002 extending in a cruciform pattern. As shown, the longitudinal axis L1 of the yarn half can be disposed at an angle θ1 of about 45 degrees with respect to the longitudinal axis LC of the central region 1002, and the L2 of the remaining half of the yarn can be May be positioned at an angle θ2 of about 45 degrees with respect to the longitudinal axis LC of the central region 1002, or may be positioned at another angle 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 creates a mesh wing region and a solid central region 1002, for example, by laser cutting or punching the film into a square, circle, diamond, etc. shape. And 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 to the tissue, and in certain embodiments, these auxiliary portions 1000, 1000' are substantially smaller in size, shape, and structure. 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, wing portion 1014 has a plurality of openings 1018 formed therein to allow wing portion 1014 to flex with tissue T during expansion and contraction of tissue T. Openings 1018 can have a wide variety of dimensions, shapes, and configurations, can be circular, oval, rectangular, and the like, and can be positioned at various locations throughout wing portion 1014. In the exemplary embodiment, openings 1018 are slits positioned in a plurality of rows, the rows being substantially parallel to longitudinal axis LC of central region 1012. The longitudinal axis of the slit 1018 may be parallel to the longitudinal axis LS of the staple 1008. The number of longitudinal rows and the number of openings 1018 arranged in each row may vary. In the exemplary embodiment, the row adjacent to the central region 1012 may have a smaller number of openings 1018 compared to the row adjacent to the outermost edge 1014a of the wing portion 1014. For example, the row adjacent to the central region 1012 may have three openings 1018 formed therein, while the row adjacent to the outermost edge 1014a of the wing portion 1014 has It may have four openings 1018 formed. In this way, the flexibility of the wing portion 1014 can be increased from the central region 1012 to the lateral edges, and strain distribution throughout the tissue T can be further enhanced.

  19A and 19B show another embodiment of a tissue aid having wings for distributing strain throughout the tissue. FIG. 19A shows an auxiliary portion 1020 having a central region 1022 and a wing region 1024, where both regions are formed from multiple layers. As in the previous embodiment, the central region 1022 may have a substantially 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 may 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 can be a flexible material, such as PDS®, PGA, Neoveil®, ORC, or other polymers, And biologically derived material structures disclosed herein or combinations thereof. The geometry and structure of the material (material thickness, fiber orientation, polymer chain orientation, pore pattern, etc.) can be used to create the desired isotropic or anisotropic deformation properties. The bottom layer of material 1026b may also be substantially flexible, and in certain embodiments may have a higher flexibility as compared to top layer 1026t. Bottom layer 1026b may have a shape that matches the shape of top layer 1026t, and is shown as having a substantially rectangular shape. Bottom layer 1026b may have a greater surface area compared to top layer 1026t, such that bottom layer 1026b extends beyond the lateral edge of top layer 1026t. As shown, the side edges of the lowermost layer 1026b may be scalloped with a plurality of semi-circular protrusions 1028 along the wing portion 1024. These semi-circular protrusions may be spaced at equal distances along the edge, or may be separated and spaced in groups of two, three, four so that the group of protrusions is May be arranged at an equal distance along the line. When stapling the auxiliary portion 1020 to tissue, the top layer 1026t of the material 1026t is positioned away from the tissue and does not directly contact the tissue, while the bottom layer 1026b makes direct contact with the tissue. Further, the protrusions can be positioned away from the staple rows, dispersing strain throughout the tissue T and preventing the formation of leaks. The bottom layer 1062b is formed from a flexible material, such as PDS®, PGA, Neoveil®, ORC, or other polymer, and the biological material structures disclosed herein or combinations thereof. can do. The geometry and structure of the material (material thickness, fiber orientation, polymer chain orientation, pore pattern, etc.) can be used to create the desired isotropic or anisotropic deformation properties. In one embodiment, at least one of the top layer 1062t and the bottom layer 1062b is at least partially composed of PDS® to assist in bonding 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 with a wing portion 1024 having a central region 1022 and a plurality of protrusions 1024 for strain distribution. In other aspects, the auxiliary material may include more than two layers of material. For example, one or more intermediate layers (not shown) of the material may be positioned between the top and bottom layers, which may be more rigid compared to the top and bottom layers. You may. The layers can be joined together using known manufacturing techniques such as laminates, adhesives, and the like. The protrusion 1028 of the wing portion 1024 of the auxiliary material can also be formed by using a known manufacturing technique such as a laser cutting method, a stamping method, and a punching method.

  Another exemplary aid is shown in FIG. 20, which includes wing regions having a wide variety of geometries. As shown, the auxiliary portion 1020 'can have a perimeter wing region 1024' that extends around the perimeter of the central region 1022 'and is formed therein and includes a wing region 1024'. There may be a plurality of surface features 1028 'evenly spaced along. The surface features 1028 'may have a generally boomerang-shaped configuration and may include a bend 1023' and first and second arms 1025 ', 1027' extending therefrom. As shown in FIG. 20, the bends 1023 'can be positioned along the edges 1022a', 1022b ', 1022c' of the central region 1022 'and the ends 1025t' of the arms 1025 ', 1027', 1027t 'can be positioned on the outer edge of wing area 1024'. Thus, the thickness of wing region 1024 'in a direction transverse to the longitudinal axis of central region 1022' can vary, and the thickness of wing region 1024 'in a direction parallel to the longitudinal axis of central region 1022'. It can also vary. 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 aid including a wing portion with a modified edge. For example, the wing portion 1034 of the auxiliary portion 1030 of FIG. 21A may include a crest portion 1034p and a valley along its entire length such that the wing portion 1034 is atraumatic and does not increase the likelihood of forming a leak in tissue. It may have a sinusoidal outer edge with a portion 1034v. The wing portion 1034 'of FIG. 21B includes a central region 1032' and a first material 1036 'forming the wing portion 1034', the wing portion 1034 'loops around the central region 1032', and the central region 1032 ' And has a curved edge that extends back toward the edge to form an elliptical opening 1035 '. In certain aspects, the second material 1038 'is disposed within the elliptical teardrop-shaped opening 1035', such as by laminating the first material 1036 'to form an auxiliary portion 1030'. The thickness of this second material 1038 'may 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 may have a plurality of openings 1035", such as a triangular opening formed therein, that may form a protrusion 1038 "similar to the protrusion 1028 shown in FIG. 19B. However, the protrusion 1038 "may have a corner instead of a rounded edge. 21A-21C can be formed from a variety of materials, such as any of the flexible or stretchable polymer materials described herein. In use, the assists. Any one of 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 auxiliary 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 can be positioned inside the staple line. Can be positioned. In certain embodiments, as the tissue expands or contracts, the auxiliary may extend or flex in a direction transverse to the staple rows, or may extend in multiple directions, such as along the outer surface of the tissue T as shown. Can be configured. Those skilled in the art will appreciate that the edges of the wing portions may be shaped in other ways 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 denser woven material compared to the woven material of the wing portion 1044 of the auxiliary portion 1040. In other aspects, as shown in FIG. 22B, the lower density woven material may wrap all sides of the higher density woven material. In either embodiment, the wing portion 1044 may have a soft, atraumatic margin 1046 that is less likely to puncture or otherwise damage the tissue and form a perforation in the tissue. 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 above the bottom layer of the material 1048b ′, and the liquid 1047 ′ is passed through the top layer of the material. It is wicked in the space between 1048b 'and the bottom layer 1048t'. These auxiliaries can be formed from various woven materials known in the art, such as ETHISORB® (Ethicon, Inc., Somerville, NJ). In one embodiment, the central region 1042 may be a film of a solid but deformable absorbent material.

  Auxiliary materials for use with staplers deploying variable thickness staples are shown in FIGS. As shown in the figure, the thickness of the auxiliary portion 1050 can change in the side 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 can have a thickness that decreases / tapers in a lateral direction from the central axis 1056 of the auxiliary portion 1050 to the outer peripheral edge thereof. As in the previous embodiment, the auxiliary material 1050 may include a central region 1052 and a wing portion 1054. Auxiliary portion 1050 may include an elongated slot portion 1058 formed along central axis 1056 of auxiliary portion 1050 and having a size and shape that matches the size and shape of the 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 an anvil 54 having a thickness that varies laterally so that the stapler 10 can deploy staples (not shown) of various heights. As shown, the thickness TO of the anvil 54 near the cutting member slot may be greater than the thickness TE of the anvil 54 near its lateral edges. Auxiliary portion 1050 may be coupled to cartridge assembly 52 and / or anvil 54 such that at least central region 1052 of auxiliary portion 1050 is in direct contact with tissue contacting surfaces 60, 58 of cartridge assembly 52 / anvil 54. As shown, the tissue contacting surface 58 of the anvil 54 may include one or more mating points 1057 for attaching the auxiliary portion 1050 to the anvil 54. As described in further detail below, the wing portion 1054 of the auxiliary portion 1050 may be wrapped around and attached to the cartridge assembly 52 and / or anvil 54. In this manner, 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. And can be arranged in parallel. As shown in FIG. 23D, when the auxiliaries 1050, 1050 'are stapled to the tissue, the wing portions of the auxiliaries 1050 are positioned 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 portions described above. . As shown, the auxiliary portion 1050 'can have similarly positioned portions 1052', 1054 '.

  Any auxiliary material may include various mechanisms for increasing friction between the auxiliary material and the tissue to ensure that the auxiliary material remains in the desired position. For example, the auxiliary portion 1060, 1060 'of FIGS. 24A and 24B includes a plurality of teeth 1061, 1061' formed on its tissue contacting surface and terminating at points 1063, 1063 'that can penetrate tissue. As shown, the teeth 1061, 1061 'can be spaced apart at equal distances in the lateral direction of the auxiliary portions 1060, 1060'. The teeth 1061, 1061 'can be formed in the auxiliary portions 1060, 1060' using a 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 '. 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', as in FIG. 24C, which illustrates multiple rows of the auxiliary portions 1060 '. . In another embodiment shown in FIG. 25A, the auxiliary portion 1060 "may include a plurality of micropillars 1063" formed on its tissue contacting surface, the micropillars 1063 "being configured to penetrate the tissue T. As shown in FIGS. 24D and 25B, the teeth 1063 and / or the micropillars 1063 ″ can penetrate the tissue T directly, so that when the tissue T expands and contracts, the auxiliary parts 1060 and 1060 ′ can be formed. Sliding with respect to the staple 1008 can be prevented. In certain aspects, the micropillars 1063 "can have a diameter D1 in the range of about 0.01-0.50 mm and a height H1 in the range of about 0.05-0.50 mm.

  Another embodiment of the auxiliary is shown in FIGS. In this embodiment, an aid such as the aid 1000 of FIGS. 17A and 17B is used with a tip extension 1070 that can be coupled to the anvil 54 and / or the cartridge assembly 52 of the surgical stapler 10. As shown in FIG. 26A, the distal end 1004d of the auxiliary portion 1000, ie, the distal end 1004d of the wing portion 1004, can terminate at or distal to the distal most 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, can terminate at or near the distal most end 54d of the anvil 54. A tip extension member 1070 can be added to the cartridge assembly 52 and / or anvil 54 to replace or supplement the distal portion of the ancillary material 1000. Proximal end 1070p of tip extension member 1070 is formed and dimensioned therein so as not to obstruct or cover the slot formed in anvil 54 for receiving a cutting member (not shown). It may have a notch 1072. 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 comprise a perforation 1078 extending across the longitudinal axis LN of the tip extension member 1070. In use, the auxiliary portion 1000 can be positioned on the anvil 54, and the distal extension 1070 can also be coupled to the anvil 54. As shown in FIG. 26B, anvil 54 and cartridge assembly 52 can grasp tissue T therebetween, and a portion of auxiliary portion 1000 can extend distally beyond tip extension member 1070. . That is, the distal end 1070d of the tip extension member 1070 can be positioned distal to the distal end 1004d of the auxiliary portion 1000. Anvil 54 and cartridge assembly 52 can deploy staples 1008 through tissue T and auxiliary portion 1000, while wing area 1004 of auxiliary portion 1000 does not include staples 1008 extending therethrough. The wing area 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 area 1004. In certain embodiments, the tip extension member 1070 can be a semi-flexible material and is used with the aid 1000 to help release strain on the tissue T and / or provide strength to the aid 1000. You may. In use, the distal end of tip extension member 1070 can be removed from anvil 54 and / or cartridge before, during, and / or after stapling tissue T.

  Although the above-described auxiliary mechanism is illustrated as a separate embodiment, the auxiliary can have any combination of the above mechanisms.

Attachment and Release Mechanism Between End Effector and Auxiliary Part A variety of mechanisms, such as cartridge assembly 52 or anvil 54, may be used to attach the auxiliary part having wings 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 mate the aid to the cartridge assembly 52. 27A-27B show auxiliary members 1000 ', 1000 "having a keying engagement mechanism with a corresponding engagement mechanism formed on anvil 54. More specifically, FIG. 27A illustrates auxiliary member 1000'. 27A shows an auxiliary portion 1000 'having a plurality of cylindrical projections 1003' formed on a surface 1007 'oriented away from the tissue contacting surface 1005' of the anvil 54. Fig. 27A shows the longitudinal axis LA of the anvil 54 and Although three cylindrical protrusions 1003 'are shown spaced apart along a parallel axis, any number of protrusions 1003' may be formed at various locations along the auxiliary portion 1000 '. 54L 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 outer surface 54L of the cylindrical protrusion 1003 '. Height (Figure ) May vary, may range from about 0.25 to 1.00 mm, and the height is measured perpendicular to the surface 1007 'of the auxiliary portion 1000'. 27B may have other dimensions and shapes.In another embodiment, as shown in FIG. 27B, the auxiliary portion 1000 "extends parallel to the longitudinal axis LA of the anvil 54. There may be a single elongated rectangular protrusion 1003 ″ present. The outer surface of the anvil 54 is adapted to receive the rectangular protrusion 1003 ″ therein when the auxiliary portion 1000 ″ is wrapped around the anvil 54. It may further include a corresponding elongated rectangular recess 53 '. The height (not shown) of the rectangular protrusion 1003 "may vary, but is substantially the same as the height of the cylindrical protrusion 1003' described above. Range. Although only the first outer surface 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 surface (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 may be connected to the anvil / cartridge assembly in other ways. As shown in FIGS. 28A and 28B, a strand of suture 1003 ″ ″ can connect the auxiliary to anvil 54. Suture 1003 "" can extend from first outer surface 54L of anvil 54, across the tissue contacting surface of the auxiliary, to second outer surface 55L of anvil 54. First and second recesses 53 '", 55'" can be formed on the first and second outer surfaces of anvil 54, and the first end of suture 1003 '" A second end can be received in a second recess 55 ″ ″, and a second end can be received in one recess 53 ′ ″. The length of the suture 1003 ′ ″ and / or the dimensions of the recesses 53 ″ ′, 55 ″ ″ may be determined when 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, while and / or after the staples 1008 are deployed in the tissue T, the cutting member 59 can be passed through the anvil 54. When advanced, the cutting member 59 cuts the suture 1003 ′ ″ so that the distal end of the suture 1003 ″ ″ slides out of the recesses 53 ′ ″, 55 ′ ″, thereby 29A and 29B show the strands of suture 1003 '"extending around the anvil 54 and connecting the multi-layered auxiliary portion 1020 to the anvil 54. The auxiliary portion can be released from the anvil. In the embodiment By passing the cutting member (not shown) forward with respect to the anvil 54, the suture 1003 "" is cut and the suture 1003 "" is removed from the recesses 53 ", 55" "of the anvil 54. When opened, the auxiliary part 1020 can be released. As will be apparent to those skilled in the art, any number of strands of suture can be used to couple the aid to one of the cartridge assembly 52 and the anvil 54 and to a recess formed therein. May be different as long as they are configured to receive a portion of the suture therein.

  30A-30B show other mechanisms for attaching the auxiliary to the anvil / cartridge assembly. In this embodiment, the anvil 54 of the surgical stapler 10 can advance in a slot 61, referred to as a longitudinal track, and can move between a proximal end 61p and a distal end 61d of the track 61. 59. As shown in FIG. 30B, a driver 1081 including first and second elongated members (not shown) may be arranged in the longitudinal track 61. Three cylindrical protrusions (not shown) extend from the elongate member into recesses 53 "", 55 "" formed in both outer surfaces 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 oriented across the longitudinal axis of the driver. Here, the protruding portion 1083 is cylindrical. The wing portion 1084 of the ancillary 1080 may be located on the outer surface of the anvil 54 and may include a plurality of protrusions oriented across the longitudinal axis LA of the anvil 54 when coupling the ancillary 1080 to the anvil 54. A portion 1083 'can be included. As shown in FIG. 30D, ancillary 1080 may be used to mate with the first outer surface 1038 'of the anvil 54 and the second outer surface of the anvil 54 to mate with the first outer surface of the anvil 54. Before use, the first driver 1081a can be positioned on the first outer wall of the track 61 and the second driver 1081b can be positioned on the track 61 before use. The proximal ends of the drivers 1081a, 1081b can be positioned at the proximal ends of the tracks 611, 1081b when the drivers 1081a, 1081b are disposed within the tracks 61. The width W1 between them is greater than the distance W2 between the drivers 1081a, 1081b at and / or distal to the protrusion 1083 '. For simplicity, there may be beveled portions 1085p, 1087p, the width of which is measured across the longitudinal axis LA of the anvil 54 shown in Figure 30E. The width W2 between the upper drivers 1081a, 1081b may be smaller than the width WC of the cutting member 59. In this manner, the cutting member 59 is advanced toward the distal end 54d of the anvil 54. 30F, the width between the drivers 1081a, 1081b can be increased, and the protrusions 1083 push the corresponding protrusions 1083 'on the auxiliary portion 1080 away from the anvil, as in FIG. 30F. Can release the auxiliary from the anvil 54. In certain embodiments, the auxiliary 1080 allows the cutting member 59 to advance in the track 61. Te driver 1081a, when a force in 1081B, as auxiliary section 1080 may be better released from the anvil 54, a flat, may be biased to substantially planar shape.

  31A to 3B show a mounting mechanism for mounting the auxiliary unit on the anvil / cartridge assembly. Mounting mechanism 1090 can have a wide variety of dimensions, shapes, and configurations, and has a first curved arm 1092a having a radius of curvature that matches the radius of curvature of first and second outer surfaces 54L, 55L of anvil 54. And a second curved arm 1092b, wherein the arms 1092a, 1092b can terminate in a diagonal mechanism 1093a, 1093b that can be gripped by a 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 vertically into the base 1094 and is positioned along the central longitudinal axis of the mounting mechanism 1090 for insertion into the cutting member slot 54s of the anvil 54. A track extension 1094e may be further included. As shown in FIG. 31A, the first inner surface 1094a of the mounting mechanism 1090 may 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, a second inner surface 1094b of the mounting mechanism 1090 may be defined by a second curved arm 1092b and a second portion of the base 1094 from the second arm 1092b to the track extension 1094e. In this manner, the mounting mechanism 1090 can be substantially E-shaped to receive the anvil 54. As shown in FIG. 31B, an auxiliary portion 1000 having a central region 1002 and a wing region 1004 can be positioned and sandwiched between the inner surface of the mounting mechanism 1090 and the tissue contacting surface of the anvil 54, as shown in FIG. As shown, the mounting mechanism 1090 is clamped to the anvil 54. The track extension 1094e can facilitate achieving a tight fit between the mounting mechanism 1090, the auxiliary part 1000, and the anvil 54 with substantially no gap therebetween. After the auxiliary section 1000 has been coupled to the anvil 54, such as using any of the attachment mechanisms 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 accomplished, for example, by pushing the diagonal mechanisms 1093a, 1093b of the curved arms 1092a, 1092b away from each other and releasing the anvil 54 with the assist 1000.

  Another exemplary mounting mechanism is shown in FIGS. The mounting mechanism 1090 'can be packaged as a kit with the stapler end effector. Alternatively, 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 1000, or in another non-exemplary embodiment, the auxiliary 1000 can be Once removed, it can be secured to the anvil 54 and cartridge assembly 52. 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. It can be configured to As shown in FIG. 32B, the mounting mechanism 1090 'can be, and need not be, configured to contact a central region (not shown) of the auxiliary portion 1000 with the tissue contacting surfaces of the anvil / cartridge assemblies 54, 52. If present, a wing portion (not shown) can be configured to be shaped around the anvil 54. The mounting mechanism 1090 'can be molded from a single molding material having an upper holding portion 1104 and a lower holding portion 1102, the holding portion being sized and sized to receive the 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, 1102 may be disposed at an angle θ L with respect to each other, which angle is in a range of about 10 to 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 so that the angle θL between the holding portions 1102 and 1104 is fixed. As shown, support member 1106 may be a substantially solid member to provide rigidity to mounting mechanism 1090 '. A first end of the support member 1106 can terminate in a gripping mechanism 1108, which is configured to be gripped by a user (eg, between a user's thumb and a non-thumb finger). First and second planes 1108a, 1108b. The gripping mechanism 1108 may further include one or more surface features 1110 to increase friction 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 grip the gripping mechanism 1108 to position the distal ends 1102d, 1104d of the retaining portions adjacent 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 mounting 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 / Auxiliary material 1000 can be wrapped around its outer surface by sliding along 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. With wing region 1004 positioned in this manner, the user retracts mounting mechanism 1090 'in the opposite direction, distally away from end effector 50, and is ready to insert end effector 50 into a patient. Although reference has been made to a single auxiliary 1000 mounted on the anvil 54, the auxiliary 1000 'can be mounted on the cartridge assembly 52 as well. Auxiliary material 1000, such as the material shown in FIGS. 32A-32C, may be a shape memory material so that 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 deploying on tissue.

Delivery of Auxiliary Parts to a Patient An end effector having one or more auxiliary parts coupled thereto can be delivered to various sites of the patient, such as the thoracic cavity, stomach, and the like. As will be apparent to those skilled in the art, the auxiliary can be delivered through an access port such as a trocar that extends into the patient. Any of the auxiliaries herein can include a mechanism to assist in delivering the auxiliaries into a patient. For example, FIG. 33A illustrates 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 1000 is shown coupled to the anvil 54, another auxiliary 1000 'may be coupled to the cartridge assembly 52 prior to inserting the end effector 50 into a patient. 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 to minimize the width of the auxiliary material, as shown in FIG. 33B. Proximal portion 1004p of wing region 1004 can be configured to guide. Because the width of the anvil / cartridge assembly 54, 52 with the auxiliary 1000 thereon is approximately the same as the width of the anvil / cartridge assembly 54, 52 without the auxiliary, this results in the end effector 50 and the auxiliary 1000. Into an access port, such as port 1202 formed in trocar 1200. In certain aspects, this distal portion 1004d of wing region 1004 is formed from a more rigid material as compared to the rest of wing region 1004 to help guide auxiliary material 1000 into port 1202. can do.

Stapling the Aid to Tissue The aid can include features that facilitate multiple firings of staples along the tissue. FIG. 34A shows an embodiment 1300 of an end effector 50 having a first auxiliary material and a second auxiliary material 1400, 1400 ′, wherein 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, the aids 1400, 1400 'may each include a plurality of layers, the layers having various widths in a direction transverse to the longitudinal axis (not shown) of the anvil / cartridge assemblies 54, 52. Can have. As the tissue is grasped between the anvil 54 and the cartridge assembly 52, the first tissue contact layer 1402, 1402 'of each of the assisting portions 1400, 1400' is positioned adjacent to the tissue (not shown). be able to. In certain aspects, the first tissue contacting layers 1402, 1402 'can be formed from a material configured to seal around a staple line, such as an elastomeric material. The first tissue contacting layers 1402, 1402 'may have a width W5 substantially transverse 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 rather comprises a first portion 1402a and a cutting member slot positioned on a first surface of the cutting member slot 54s. 54s may include a second portion 1402b positioned on the second surface. In other aspects, first layer 1402 can be a single continuous piece of material. The second layers 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 'can help prevent stretching of the tissue T adjacent the staple 1008. The third layer 1408, 1408 'is adapted for 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 layer 1408, 1408 'can have a width W7 that is larger than the width WA of the anvil 54, but smaller than the width W6 of the second layer 1406. This third layer 1408, 1408 'may be semi-rigid to help relieve tissue T strain as tissue T expands and contracts. The longitudinal length of the layer, measured across the width, may also vary. Preferably, the third layer 1408, 1408 'is along the longitudinal axis of the anvil 54 as compared to the respective longitudinal lengths of the first and second layers 1402, 1402', 1406, 1406 '. Has the longest length measured. As shown in FIG. 34B, a plurality of auxiliary portions 1400, 1400 ′, 1400 ″ can be arranged in a row and continuously deployed on a tissue, and depending on the longitudinal length of the layer, the first portion of the auxiliary portion 1400 can be formed. Layer 1402 can provide an area 1410a, 1410b that overlaps with first layer 1402 'of another auxiliary portion 1400'. In this manner, staple 1008 can include multiple (eg, three or more) layers 1402, Unlike the case where 1406, 1408 are positioned in these overlapping regions, they can still penetrate these overlapping regions.Figure 33C shows two stapled at approximately a 90 degree angle to tissue T. Auxiliary parts 1400, 1400 'are shown, where the first auxiliary part 1400 has a first end and the second auxiliary part 1400' has a second end. As such, the first and second extremities form an overlap region 1410a, and these auxiliaries 1400, 1400 'allow the user to adapt the auxiliaries to accommodate a wide variety of tissue geometries. These multi-layer auxiliary parts 1400, 1400 'can be varied in any number of ways.Layers 1402, 1406, 1408 can have various thicknesses. In the illustrated embodiment, the second layer 1406 has a smaller thickness than each of the first and third layers 1402, 1408. For example, the first layer 1402 may have a thickness of about 3-15 mm. The second layer 1406 may be in the range of about 5-20 mm, and the third layer 1408 may be in the range of about 3-20 mm.In certain embodiments, these layers 1402, 1404 1406 and 1402 ', 1404', 1406 'can be laminated together prior to bonding to the anvil / cartridge assemblies 54, 52. In certain aspects, the layers 1406 and 1406' are PDS (R). May be at least partially composed of an absorbent material.

Strengthening Tissue with Sealants and Aids Any of the aids herein can be used with sealants to help maintain a seal around the staples as the tissue expands and contracts after surgery. The sealant may have a wide variety of formulations and various viscosities and cure behaviors. Generally, the sealant can be manufactured 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 (eg, a fluid, a gel, a foam, etc.) and the second state may be a cured state (eg, a solid, rigid member, etc.). 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 hardened state after a predetermined time has elapsed. In certain aspects, the sealant can be formed from a biomaterial. In some embodiments, the sealant can assist in wound healing by releasing various compounds during and / or after the sealant is hardening in the patient's body. By way of non-limiting example, sealants may be therapeutic agents such as wound healing promoters (eg, transforming growth factor β, etc.), antibacterial agents (eg, triclosean, ionized silver, etc.), and other known agents. Over time to aid in the healing of tissue near the location of the sealant in the body. In one embodiment, the fibrin sealant can include two reactive components that are combined immediately prior to delivery to a patient, such as thrombin and a bioactive ingredient (BAC2), fibrinogen and factor XIII. In certain aspects, 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 aid of FIG. 17B with the sealant 1500 delivered thereon. As shown, sealant 1500 can be delivered to substantially cover central region 1002 and wing region 1004 of auxiliary portion 1000, or in another embodiment (not shown), sealant 1500 It may be selectively delivered only to the central region 1002 and not to the wing region 1004.

  The sealant 1500 can be delivered to the auxiliary in other ways, and need not be delivered to the outer surface of the auxiliary 1000. For example, FIG. 35B shows the multi-layered auxiliary portions 1700, 1700 'stapled to the tissue T. The layers 1702, 1704 can be formed from a variety of materials, but in the illustrated embodiment, a first layer 1702 of a fibrous scaffold positioned adjacent the tissue T and a second layer of a resilient film. Layer 1704. A delivery tool 1706 having a needle 1708 can have a sealant 1500 disposed therein and can pierce a first layer 1702 of fibrous scaffolds. As in FIG. 35C, the sealant 1500 can be delivered to this first layer 1702, and the injection needle 1708 can then be removed from the patient's body. The sealant 1500 may be directly bonded to the tissue T and / or may be held firmly to the tissue by the layer 1704 and, as in other embodiments, may displace the staples 1008 on the staple line. It may have wing areas 1704, 1704 'that disperse to outside tissue. If the sealant is Evicel®, the material forms a fibrin clot from fibrinogen. Without loss of generality, other sealants form a cured sealing structure by a variety of mechanisms useful for sealing leak paths. 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 similar to the auxiliary portion 1700 and the layers 1702 and 1704 described above.

Sealants may be used to strengthen tissue in other ways. For example, FIGS. 36A-36C show a sealant 1500 delivered to the thoracic cavity 1800 of a patient. As shown in FIG. 35A, 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 aspects, components A, B, C can include acid solubilized collagen A, fibrinogen B, and thrombin C. Trocar 1200 can extend into thoracic cavity 1800 via an incision 1904 made in patient 1906. The applicator tool 1908 can have a shaft 1910 extending through the trocar 1200, 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 gripped by a user. The handle assembly 1912 may be a pistol grip-type handle assembly and may include one or more actuators, such as a lever 1914 that can be rotated to operate the device 1908. The canister 1902 and the applicator tool 1908 can be connected together in various ways, such as through a tube 1916. The tube 1916 may be substantially flexible to facilitate movement of the applicator tool 1908 during a procedure. The canister 1902 can have a second tube 1918 coupled to the canister 1902 and connected to a gas source S so that gas 1920 can be delivered to the canister 1902. Non-limiting examples of gas 1920 include CO ₂ , O _{2, and the} like. In certain aspects, the gas supply S may be a continuous gas supply, such as a continuous CO ₂ gas supply available in a hospital operating room. One or more valves (not shown) may be located in tube 1916, in handle assembly 1912, in shaft 1910, or in any other portion of system 1900, and may include handle assembly 1912. By actuating the actuator, such as by pivoting the upper actuator 1914, the valve can be selectively opened and closed. For example, one valve can control the flow of gas 1920 into canister 1902 and another can control the delivery of sealant 1500 to applicator tool 1908. After stapling the tissue T, such as by deploying the staples of one or more cartridges to the lung tissue, as in FIG. 36B, the distal end 1910d of the shaft 1910 of the applicator 1908 is positioned near the 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 from the staple line. The user can actuate the actuator 1914, such as by gripping the handle assembly 1912 of the applicator tool 1008 and moving the rotatable lever 1914 proximally. This opens the valve located within the system 1900 and initiates delivery of the gas 1920 to the canister 1902, nebulizing the sealant 1500 and encapsulation that can be sprayed directly onto the tissue T as shown. Liquid particles can be formed. In this manner, the sealant 1500 can be delivered to the tissue along the staple line as shown in FIG. 36C. Thereupon, 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, the sealant 1500 may be delivered to an auxiliary portion, such as any of the auxiliary portions described herein, rather than directly to the tissue T. As will be apparent to those skilled in the art, the sealant can be delivered to any portion of the tissue, such as only the tissue on and / or outside the staple line.

  The sealant can be delivered in various 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 supply, canister, and the like. However, in this embodiment, the system delivers the atomized sealant 1500 directly through the trocar 1200 and does not include an applicator tool. In this embodiment, the delivery of gas 1920 to the canister 1902 can be conveniently controlled using a valve on the gas supply, without the need for the system to include a valve. By supplying gas to the canister 1902, it is also possible to atomize the sealant 1500 instead of forming encapsulated liquid particles, and the gas 1920 creates 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 thoracic cavity and can be hardened on any surface of the tissue, such as forming a hardened area 1500h along the entire surface of the patient's lungs. .

  In embodiments where the sealant is blood, such as autologous blood, blood may be collected from the patient and applied to an adjunct. As a non-limiting example, the supplement may be a known hemostatic agent, ORC, and applying blood to the ORC supplement results in clot formation, resulting in an effective sealing structure. . One skilled in the art will appreciate that blood, such as autologous blood, can be applied to various auxiliaries to provide an improved sealing structure. Further, those skilled in the art will appreciate that the amount of blood applied to the supplement may vary depending on a number of factors, including the type and location of the tissue, the age and condition of the patient, and the identity of the supplement. Will do. However, in general, when the supplement is an ORC material, blood may be applied in an amount in the range of about 5-10 cc per staple line used to apply the supplement to tissue.

Reprocessing The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. However, in each case, the device can be adjusted for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly. In particular, the device can be disassembled, and any number of specific parts or portions of the device can be selectively replaced or removed in any combination. Once certain parts have been cleaned and / or replaced, the device can be reassembled for later use at a reconditioning facility or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will recognize that reconditioning of a device can utilize various techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

  In some embodiments, the devices described herein can be processed before surgery. First, a new or used instrument, which may include auxiliary materials, is obtained and, if necessary, washed. The instrument can then be sterilized. In some embodiments, the device can be dried, for example, in an oven, with a desiccant product that can have a significantly higher humidity affinity than the auxiliary material. 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 device are then placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays, or high energy electrons. The radiation kills bacteria on the instrument and in the container. In another sterilization 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 that can be left open, for example, a foil bag. Along with the instrument, ethylene oxide sterilization can be performed on the first container and the second container. The second container can then be sealed so that it is not exposed to humidity. Prior to sealing, at least one of the first and second containers may include 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 sterile container to keep the material sterile until the container is opened at the medical facility.

  Those skilled in the art will recognize 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 method for embedding a tissue reinforcing material in a tissue,
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 has a tissue reinforcing material retained thereon; The tissue-reinforcing material includes a central region configured to seal around a staple, and an outer region adjacent the central region that defines an edge of the tissue-reinforcing material;
Injecting staples from the cartridge assembly such that actuating the surgical stapler forms a staple line through the central region and into the tissue to retain the tissue reinforcing material at the surgical site. When,
When the sealant is in a first liquid state such that it solidifies on the tissue reinforcing material and enhances the sealing of the tissue on the staple line, after activating the surgical stapler, the sealant is removed from the tissue. Delivering to a reinforcing material.
2. The method of claim 1, wherein actuating the surgical stapler causes the staple to be ejected through the central region of the tissue reinforcing material.
(3) The method of embodiment 1, further comprising wrapping the outer region of the tissue reinforcing material around at least one of the cartridge assembly and the anvil to insert the cartridge assembly and the anvil into the surgical site. The described method.
The method of claim 1, wherein actuating the surgical stapler releases the tissue reinforcing material from the surgical stapler.
5. The method of claim 4, wherein actuating the surgical stapler advances a cutting member through the central region of the tissue reinforcing material.

The method of claim 1, wherein the sealant is delivered via an applicator tool positioned adjacent to the tissue reinforcing material.
7. The method of claim 1, wherein delivering the sealant comprises depositing the sealant on both the central region and the outer region of the reinforcement material.
The method of claim 1, wherein the surgical stapler forms a staple line having at least two rows of staples.
9. The embodiment of claim 1, wherein, when the sealant is delivered to the tissue-strengthening material in the first liquid state, the sealant penetrates and solidifies within a space within the tissue on the staple line. the method of.
(10) A system for strengthening the sealing of a tissue,
A sealant configured to transition from a first liquid state to a second solid state;
A container configured to retain the sealant therein when the sealant is in the first liquid state, the container discharging a first port for receiving a gas and atomized sealant. A container having a second port for
An applicator coupled to the second port of the container, the applicator configured to deliver the atomized sealant to a surgical site.

The system according to claim 10, wherein the applicator tool comprises a trocar.
(12) The system according to embodiment 10, wherein the gas comprises carbon dioxide.
(13) The system of embodiment 10, wherein the sealant comprises a mixture of collagen, fibrinogen, and thrombin.
14. The system of claim 10, further comprising a first tube extending between the second port of the container and the applicator for receiving an atomized sealant.
15. The system of claim 10, wherein the sealant is configured to transition from the first liquid state to the second solid state after a predetermined time has elapsed.

(16) A method for delivering a sealant to a patient's body, comprising:
Transitioning the sealant from a first liquid state to a second atomized state by delivering gas to a container holding the sealant therein;
Delivering the atomized sealant via an applicator tool extending through an access port in the patient, wherein the atomized sealant solidifies on tissue and seals thereon Forming a method.
17. The method of embodiment 16, further comprising positioning the applicator tool in a patient's thoracic cavity prior to delivering the gas to the container.
18. The method of claim 16, wherein the applicator tool comprises a trocar, and wherein the nebulized sealant is delivered directly into the patient via the trocar.
19. The method of claim 16, further comprising positioning a distal end of the applicator tool adjacent a staple line in the tissue prior to delivering the atomized sealant to the tissue. Method.
(20) The method of embodiment 16, wherein the cured sealant is absorbed by the body after a predetermined time.

Claims (6)

A system for strengthening the sealing of the tissue,
A sealant configured to transition from a first liquid state to a second solid state;
A container configured to retain the sealant therein when the sealant is in the first liquid state, the container discharging a first port for receiving a gas and atomized sealant. A container having a second port for
An applicator coupled to the second port of the container, the applicator configured to deliver the atomized sealant to a surgical site.
A pre-Symbol applicator trocar, the system is configured to deliver sealant described above fog Joka through the trocar directly system.   The system of claim 1, wherein the gas comprises carbon dioxide.   The system of claim 1, wherein the sealant comprises a mixture of collagen, fibrinogen, and thrombin.   The system of claim 1, further comprising a first tube extending between the second port of the container and the applicator for receiving the atomized sealant.   The system of claim 1, wherein the sealant is configured to transition from the first liquid state to the second solid state after a predetermined time has elapsed. It said applicator is separate from the surgical stapler, as claimed in any one of claims 1 to 5 systems.

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