RU2685974C2 - Devices for compressing of staples in tissue - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: group of inventions relates to medical equipment, specifically to methods and devices for fixing a line of staples. End effector for a surgical instrument comprises a first and a second branch and support. First branch has cassette housing attached to it with possibility of removal. Cartridge body has a plurality of staple cavities configured to receive staples therein. Second branch has a thrust element with a plurality of stapling holes formed therein. At least one of first and second branches movable relative to other branch. Support has width larger than width of at least one cassette housing and thrust element. Support includes a compressible central area which is configured to seal around the staple, and a tension release area adjacent to the compressible region. Tension removal area has multiple holes formed in it, and area of tension removal passes from at least two sides of central area, where the support is detachably held on at least one cassette body and the thrust element and is detachable from them when releasing the staples from the cassette body into the compressible support region. Multiple openings are located at a distance from each other so that the tension release area is more flexible along its lateral part, part of the tension release area adjacent to the compressible area. Method for implanting tissue-reinforcing material into tissue comprises fixing tissue between cartridge assembly and surgical stapling instrument thrust element in surgical field and controlling surgical stapling instrument for pushing staples out of the cartridge assembly to form a staple line through the central region into the fabric to hold the tissue securing material in the surgical site. At least one of cartridge assembly and thrust element has tissue fastening material detachably attached thereto, wherein the tissue fastening material comprises a compressible central region configured to seal around the staple, and a flexible supporting region adjacent to the central region defining an edge of the fabric securing material. Method further includes placing a cassette assembly and a thrust member into the operative field, wherein the flexible support region is folded around at least one of the cassette assembly and the abutment member.EFFECT: inventions enable to provide tissue sealing in line of staples and / or to prevent formation of streaks in tissues.7 cl, 37 dwg, 1 tbl

Description

FIELD OF INVENTION

The object of the invention disclosed in this document relates to methods and devices for fixing the line of brackets.

BACKGROUND OF THE INVENTION

Surgical suturing instruments are used in surgical procedures for compacting, separating and / or dissecting body tissues by closing openings in the tissue, blood vessels, ducts, shunts and other objects or parts of the body involved in a particular intervention. The openings may be of natural origin, such as ducts in blood vessels, airways or internal cavities or organs such as the stomach, or they may be formed by a surgeon during surgery, for example, by puncturing a tissue or blood vessels with a shunt or anastomosis by cutting the fabric during the stapling procedure.

Most stitching tools usually have a handle with an elongated flexible or rigid barrel, at the end of which there are a pair of opposing branches for holding the fabric and stapling. At least one of the opposite branches is movable relative to the other. In the case of laparoscopic surgery, often one branch is fixed and the other is mobile. In some devices (for example, in an open linear stapling instrument), the opposing jaws can be divided by the operating surgeon and reconfigured to provide the relative movement necessary to place the tissue. As a rule, brackets are contained in a cassette with brackets in which several rows of brackets can be placed and which is often located in one of the two branches to push the brackets to the surgical field. When applied, the branches are arranged in such a way that the object to be stapled is located between the branches, and the brackets are pushed out and superimposed when the branches are closed and the device is activated. Some stitching tools contain a knife that is capable of moving between rows of brackets in a cassette with brackets, for longitudinal cutting of the stitched fabric between rows of brackets. Device placement, device component or system control, and other device actions, such as closing, starting, etc., can be performed in various ways, for example, electromechanically, mechanically, or hydraulically.

Although the surgical stapling instruments have improved over time, there are still potentially potential problems with them. Although rare, as illustrated in FIG. 1, one problem is that leaks may occur due to the fact that S brackets form holes H when they penetrate into tissue T or another object in which brackets S are located. Blood, air, fluids of the gastrointestinal tract and other liquids may leak through the holes formed by the brackets, even after the bracket has been fully applied. The T tissue to be treated can also be inflamed due to the manipulations and deformations that can occur during stitching. Moreover, brackets, as well as other objects and materials that can be implanted during the stapling procedure, do not essentially have some characteristics of the tissue into which they are implanted. For example, brackets and other objects and materials may lack the natural elasticity of the tissue into which they are implanted. One skilled in the art will appreciate that it is often desirable that a fabric retains as much of its natural characteristics as possible, as much as possible, after placing brackets in it.

Accordingly, there remains a need for methods and devices for strengthening the line of suture brackets.

SUMMARY OF INVENTION

A cassette with brackets for use in a surgical stapling instrument is presented, and it may include a cassette body and auxiliary material. The cassette case may include multiple cavities for brackets, made with the possibility of placing brackets in them. Auxiliary material may be connected to the cassette case and configured to separate from it when releasing the brackets from the cassette case into the fabric. The auxiliary material may include a solid central portion having a size and shape substantially to fit the cassette body and a pterygoid portion extending along at least two sides of the solid central portion so that the pterygoid portion extends beyond the lateral border of the cassette case in the direction crossing the longitudinal axis of the cassette case.

The solid central part of the auxiliary material may vary in any number of ways. For example, the solid central portion of the auxiliary material may be substantially rectangular in shape. In certain aspects, the solid central portion may include first and second opposite edges. In other aspects, the pterygoid portion may extend along the first and second opposite edges of the auxiliary material. In use, the one-piece central part can be made with the possibility of securing the seal around the brackets, if the auxiliary material and the brackets are connected to the fabric.

The pterygoid part can be characterized by various properties. For example, the pterygoid portion may include rounded corners. As another example, the pterygoid portion may have a mesh structure. In certain aspects, the pterygoid portion may have a plurality of apertures formed therein. When applied, the pterygoid portion may be adapted to distribute or otherwise alter the tension or deformation present in the tissue outside the brackets line if the auxiliary material is located in the tissue.

The integral and pterygoid parts can be formed from various materials. In certain aspects, the integral and pterygoid portions may be formed from a single polymer. In certain aspects, the integral and pterygoid portions may be formed from more than one material or type of materials. In certain aspects, the integral and pterygoid portions may be formed from various materials. In other aspects, the pterygoid portion may be more flexible than the integral central portion of the auxiliary material.

An end effector for a surgical instrument is presented, and it may include first and second branches, the first branch having a cassette case attached to it with the possibility of being removed, and the cassette case having a plurality of cavities for brackets made with the possibility of positioning brackets therein. The second branch may include an abutment element with a plurality of brackets forming the holes formed by them, wherein at least one of the first and second branches is movable relative to the other branch. The end effector may include a support with a width greater than the width of at least one of the body of the cassette and the stop element, while the support has a compressible central region made with the possibility of compaction around the bracket, and the tension relieving region adjacent to the compressible region. The strain relief region may have a plurality of holes formed therein, and the strain relief region may extend from at least two sides of the central region. When used, the support can be fixed with the possibility of detachment on at least one of the cassette case and the stop element and can be made detachable from them when the brackets are released from the cassette case into the compressible support area.

The end effector can vary in various ways. In certain aspects, the plurality of holes include slots. When the support and the brackets are released into the fabric, a plurality of slots may run parallel to the longitudinal axis of the brackets. In other aspects, the plurality of holes are spaced from each other in such a way that the tension release region is more flexible along its side portion than in the direction of the portion of the tension release region adjacent to the compressible region. In other aspects, the plurality of holes have such a shape and are spaced from each other that the tension release region is more flexible along its longitudinal portion than in the direction of the portion of the tension release region adjacent to the compressible region.

A method for implanting a material for fixing tissue onto a tissue is presented, it includes an engagement of tissue between the assembly of the cassette and the abutment element of the surgical stapling instrument in the surgical field, and at least one of the cassette assembly and the abutment member includes a material for fixing the tissue located on them detachable. The fabric fastening material may include a compressible central region, which is adapted to seal around the bracket, and a flexible supporting region adjacent to the central region and defining the edge of the fabric fastening material. When controlling a surgical stapling instrument, the staples can be pushed out of the cassette assembly to form a line of staples through the central region into the tissue to hold the material to secure the tissue in the surgical field.

The method can vary in any number of ways. For example, when controlling a surgical stapling instrument, the staples can be pushed through the central region and the staples cannot be pushed through the flexible supporting area of the material to secure the fabric. In certain aspects, the cassette assembly and the stop member may be inserted into the operating field with a flexible support area folded around at least one of the cartridge assembly and the stop member. When operating a surgical stapling instrument, a cutting tool can be extended through the material to secure the fabric and separate the material to secure the fabric from the surgical stapling tool. In certain aspects, when operating a surgical stapling instrument, a cutting tool is advanced through the central region of the material to secure the fabric.

BRIEF DESCRIPTION OF THE DRAWINGS

The principle of the present invention will become more clear on the example of the following detailed description in conjunction with the accompanying drawings, in which:

in fig. 1 is a side view of a tissue damaged by staples;

in fig. 2 is a perspective view of one embodiment of the auxiliary material described herein, which is attached to the stapled fabric;

in fig. 3 is a perspective view of a surgical instrument from the prior art that can be used with one or more auxiliary materials;

in fig. 4 is a perspective view with a spatial separation of the components of the end effector and the distal end of the tool barrel shown in FIG. 3;

in fig. 5 is a perspective view of the component of the three-member tool shown in FIG. 3;

in fig. 6 is a perspective view of another surgical instrument from the prior art that can be used with one or more auxiliary materials;

in fig. 7 is a perspective view of another surgical instrument from the prior art that can be used with one or more auxiliary materials;

in fig. 8 is a perspective view of the end effector shown in FIG. four;

in fig. 9 is a side view of an end effector of the prior art including an implantable cartridge with brackets;

in fig. 10 shows a side view of the bracket from the previous level of technology;

FIG. 11 is a sectional view of the end effector shown in FIG. 9.

in fig. 12 is a top view of a cassette with brackets from the prior art for use with the tool shown in FIG. 7;

in fig. 13 is a schematic representation of lines of brackets installed using a surgical stapling instrument from the prior art;

in fig. 14 shows a top view of a cassette with brackets from the previous level of technology, having a brackets pattern;

in fig. 15 is a side view of an end effector with a cassette with brackets loaded with auxiliary material;

in fig. 16 is a side sectional view of the end effector shown in FIG. 4, including supporting material;

in fig. 17A is a perspective view of an auxiliary material including a central part and a pterygoid part, the auxiliary material being connected to the cassette assembly;

in fig. 17B is a perspective view of an auxiliary material stitched with brackets to the fabric;

in fig. 18 is a perspective view of another exemplary embodiment of auxiliary material sewn with staples to the fabric;

in fig. 19A is a perspective view of an auxiliary material having edge projections adapted to distribute tension in a fabric along a line of brackets;

in fig. 19B is a perspective view of another auxiliary material having lateral protrusions, with the auxiliary material stitched with brackets to the fabric;

in fig. 20 is a perspective view of an auxiliary material including an outer region with a plurality of cuts formed therein;

in fig. 21A-21C are side views of auxiliary material having modified outer areas;

in fig. 21D is a side sectional view of auxiliary material stitched with brackets to the anatomical lumen;

in fig. 22A is a perspective view of an auxiliary material including first and second layers and woven atraumatic edges;

in fig. 22B is a side view of the auxiliary material shown in FIG. 22A, showing the first and second layers;

in fig. 22C is a side view of the auxiliary material shown in FIG. 22A, absorbing liquid between the first and second layers;

in fig. 23A is a perspective view of an auxiliary material having a variable thickness in the lateral direction;

in fig. 23B is a rear view of the thrust assembly and the cassette and two variable thickness auxiliary materials, the first auxiliary material being associated with the anvil element and the second auxiliary material being associated with the cassette assembly;

in fig. 23C is a rear view of the stop member assembly and the cassette shown in FIG. 23B having first and second supporting materials associated with it;

in fig. 23D is a side view of the first and second auxiliary material stitched with brackets to the fabric;

in fig. 24A is a side view of an auxiliary material having features of the surface formed thereon for penetration and gripping into fabrics;

in fig. 24B is a side view of another auxiliary material having surface features for penetrating and gripping into tissues;

in fig. 24C is a rear view of four rows of auxiliary material, with each row of auxiliary material having surface features fixed to the fabric;

in fig. 24D is a side view of an auxiliary material having surface features penetrating the fabric;

in fig. 25A is a side view of another illustrative auxiliary material having a number of features of a pointed surface for penetration into a fabric;

in fig. 25B is a side view of the auxiliary material shown in FIG. 24A, having the characteristics of a pointed surface, piercing the fabric;

in fig. 26A is a perspective view of a cassette assembly including supporting material for a detachable joint with a distal end of the cassette assembly;

in fig. 26B is a side view of the cassette assembly and the stop member of a surgical stapling instrument engaging tissue with the aid of the auxiliary material shown in FIG. 26A extending along the distal end of the cassette assembly;

in fig. 26C is a side view of the cassette assembly and the stop member shown in FIG. 26B placing the staples through the auxiliary material and fabric;

in fig. 27A is a perspective view of an auxiliary material having protrusions adapted to mate with corresponding depressions formed in the cassette assembly;

in fig. 27B is a perspective view of an auxiliary material having a single protrusion adapted to mate with a corresponding depression formed in the cassette assembly;

in fig. 28A is a rear view of auxiliary material extending around a cassette assembly and having first and second transverse edges associated with the cassette assembly;

in fig. 28B is a rear view of the auxiliary material and cassette assembly shown in FIG. 27A, and at the same time, the cutting tool advances through the cassette assembly to release the auxiliary material from the cassette assembly;

in fig. 29A is a perspective view of a cassette assembly including a suture connection of auxiliary material with a cassette assembly;

in fig. 29B is a perspective view of the cassette assembly and auxiliary material shown in FIG. 29A, with the suture material being separated from the cassette assembly to release the auxiliary material;

in fig. 30A is a perspective view of the barrel of a surgical stapling instrument comprising auxiliary material associated with it;

in fig. 30B is a side view of the trunk shown in FIG. 30A, showing the connection points for connecting the auxiliary material to the barrel;

in fig. 3C is a perspective view of an ejector inserted into the inside of the barrel and having a plurality of lateral expanding portions;

in fig. 30D is a perspective view of an auxiliary material for connecting with a barrel;

in fig. 30E is a partial top view of the trunk shown in FIG. 30A, with a stapler cutting tool in a first, compressed configuration;

in fig. 30F is a partial top view of the trunk shown in FIG. 30A, with a cutting tool in a second, elongated configuration in which the auxiliary material extends from the barrel;

in fig. 31A is a rear view of a cassette assembly, auxiliary material, and an insertion tool for connecting the auxiliary material to the cassette assembly;

in fig. 31B is a rear view of the tool for inserting, compressing the auxiliary material in the cassette assembly shown in FIG. 31A;

in fig. 31C is a rear view of the cassette assembly shown in FIG. 31A having an auxiliary material connected thereto, and after removing the tool for insertion from the cassette assembly;

in fig. 32A is an illustrative set comprising a holding tool and a surgical stapling tool, wherein the holding tool is configured to wrap auxiliary material around the cassette / stop member assembly;

in fig. 32B is a side view of the holding tool shown in FIG. 32A protruded proximally along the longitudinal axis of the stop member assembly and the cassette;

in fig. 32C is a perspective view of the holding tool and the stapling tool shown in FIG. 32A, with the retention tool being in the maximum proximal configuration;

in fig. 33A is a perspective view of an end effector of a crosslinking instrument having auxiliary material associated with it and located above the trocar;

in fig. 33B is a perspective view of the end effector shown in FIG. 33A having support material wrapped around the end effector, while the end effector is inserted through a trocar;

in fig. 34A is a rear view of a cassette assembly and an abutment member of a surgical stapling instrument having multi-layer auxiliary material associated therewith;

in fig. 34B is a side view of three auxiliary materials stitched with brackets to the fabric and having overlapping portions between them;

in fig. 34C is a perspective view of a first auxiliary material and a second auxiliary material sewn with brackets to the fabric and having first and second overlapping portions;

in fig. 35A is a perspective view of the first and second auxiliary materials stitched with brackets to the fabric and having a tissue adhesive delivered to the outer surface of the first auxiliary material;

in fig. 35B is a side view of the first and second auxiliary materials shown in FIG. 35A, stapled to fabric;

in fig. 35C is a side view of the first and second auxiliary materials shown in FIG. 35A having a tissue adhesive delivered to a space below the outer surface of the auxiliary material;

in fig. 35D is a side view of the first and second auxiliary materials shown in FIG. 35A, in an extended position;

in fig. 36A is a perspective view of a spray adhesive system for tissue adhesive that includes a container and an applicator tool passing through a trocar and into a patient’s body

in fig. 36B is a perspective view of the applicator tool shown in FIG. 36A, delivering fabric glue to the suture line to the fabric;

in fig. 36C is a perspective view of the sprayed fabric glue shown in FIG. 36A, cured in suture line;

in fig. 37A is a perspective view of another illustrative system for spraying tissue glue and delivering sprayed tissue glue to a patient directly through the trocar and into the patient's body; and

in fig. 37B is a perspective view of the trocar shown in FIG. 37A, delivering the sprayed fabric glue to the fabric on and along the suture line.

DETAILED DESCRIPTION

To ensure a complete understanding of the principles of design, operation, production and use of the devices and methods described in this document, some embodiments are described below. One or more examples of such embodiments are depicted in the accompanying drawings. It will be understood by those skilled in the art that the specific devices and methods described herein and shown in the accompanying figures are non-limiting embodiments, and that the scope of such devices and method is defined only by the claims. The features shown or described in connection with one embodiment may be combined with those of other embodiments. Such modifications and variations are intended to be included in the scope of the devices and methods described in this document. In addition, in the present disclosure, components with similar positions of various embodiments generally have similar characteristics when these components have the same nature and / or perform similar functions.

In the present description, reference to “various embodiments”, “certain embodiments”, “one embodiment”, “embodiment” or the like means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the phrases “in various embodiments,” “in some embodiments,” “in one embodiment,” or “in an embodiment,” or the like, in the present description do not necessarily refer to the same embodiment. Moreover, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined without distinction, in whole or in part, with the features, designs, or characteristics of one or more other embodiments. Such modifications and variations are intended to be included in the scope of the methods, apparatus, devices, and systems described in this document.

The terms "proximal" and "distal" in this document are defined relative to the physician controlling the handle of the surgical instrument. The term "proximal" refers to the area closest to the doctor, and the term "distal" refers to the area removed from the doctor. It is also proposed to use in this document spatial terms such as "vertical", "horizontal", "up" and "down" for convenience and clarity in relation to the figures. However, since the use of surgical instruments involves many orientations and positions, these terms should not be interpreted as limiting and (or) absolute.

It may be desirable to use one or more biological materials and / or synthetic materials, collectively referred to as "auxiliary materials" in this document, in combination with surgical instruments to help improve surgical procedures. These biological materials may be derived from human and / or animal sources. The person skilled in the art may refer to these types of materials as supporting materials as well as auxiliary materials.

For performing surgical interventions, various examples of devices and methods have been proposed. In some embodiments, devices and methods for open surgical procedures are presented, and in other embodiments, devices and methods for laparoscopic, endoscopic and other minimally invasive surgical procedures are presented. Devices can be activated directly by a human user or remotely with direct control by an automatic device or similar control tool. However, it will be understood by those skilled in the art that the various methods and devices described herein can be used in a variety of surgical procedures and uses. Those skilled in the art will also appreciate that the various instruments described herein can be inserted into the body in any way, such as through a natural orifice, through an incision or puncture formed in a tissue, or through an access device such as a trocar cannula. For example, the working areas or areas of the end effector of the instruments can be inserted into the patient's body directly or through an access device that has a working channel through which the end effector and the elongated barrel of the surgical instrument can be advanced.

The end effector of the surgical instruments described in this document can be made with the ability to deliver one or more synthetic materials and / or biological materials, collectively referred to as “auxiliary materials”, to the surgical field to help improve surgical procedures. These biological materials may be derived from human and / or animal sources. While many different end effectors may have an advantage due to the use of auxiliary materials, in some illustrative embodiments, the end effector may be a surgical stapling instrument. When used in conjunction with a surgical stapling instrument, the auxiliary material (s) can be placed between the staples of the stapling instrument and / or on them, inserted into a cassette with brackets, placed in the jaws, or otherwise located close to the brackets. When the brackets are installed, the support material (s) can remain at the treatment site with the brackets, in turn providing several advantages. In some cases, the auxiliary material (s) can be used to hold the sealing holes formed by the brackets when they are implanted into the tissue, blood vessels, and various other objects or body parts and / or can be used to secure the tissue at the treatment site. When attaching a tissue, it may be necessary to prevent brackets from breaking through the tissue if the tissue is affected by a disease, is cured of another treatment, such as radiation, drugs, such as chemotherapy, or taking into account another property of the tissue that changes the situation. In some cases, the auxiliary material (s) can minimize the movement of the tissue in and around the puncture sites with brackets, which may occur due to tissue deformation that occurs after stitching (for example, swelling of the lung, swelling of the gastrointestinal tract, etc. ). The person skilled in the art should consider that the puncture site of the staple can serve as a stress concentration and that the size of the hole formed by the staple will increase when the tissue around it is subjected to tension. Restricting the movement of tissue around these puncture sites can minimize the size of the holes, which can increase when exposed to tension. In some cases, the auxiliary material (s) can be made to absorb or absorb beneficial liquids, such as seals, blood, adhesives that further promote healing, and in some cases, the auxiliary material (s) can be made to collapse to form gel, for example, tissue glue, which further stimulates healing. In some cases, the auxiliary material may contain materials that, when placed in a humid environment (for example, blood, water, saline or other biological fluids) form a tissue adhesive, to obtain a seal (for example, fibrinogen and human or animal thrombin can be lyophilized). a form that is then mixed with water to form a tissue glue). Moreover, the material (s) can help reduce inflammation, promote cell growth, and in other cases improve healing.

FIG. 2 illustrates one embodiment of an auxiliary material that includes a cellular support 30, which may be attached to the tissue T to be treated, by means of a surgical stapling instrument, and which is stored at the treatment site with staples 70. The support 30 may be obtained from one or more absorbent materials and can be stamped, pressed, cut, molded, woven, smelted, extruded, consisting of composite structures and / or methods or in any other way Reinforced to facilitate the absorption, consolidation, delivery and / or retention of useful liquids, such as seals, types of glue, blood, etc. Absorbing and / or retaining beneficial fluids, such as fibrin tissue glue 40, at the treatment site can additionally help to prevent leakage and fixation of the support 30.

SURGICAL BONDING TOOL

While various surgical instruments can be used in combination with the additional materials described herein, FIG. 3 illustrates one non-limiting exemplary embodiment of the invention of a surgical stapling instrument 10 suitable for use with one or more additional materials. The tool 10 typically includes a handle assembly 12, a barrel 14 extending distally from the distal end 12d of the handle assembly 12, and an end effector 50 at the distal end 14d of the barrel 14. Because the illustrated embodiment is a surgical stapling instrument, the end effector 50 has 52, 54, although other types of end effectors with a barrel 14, a handle assembly 12 and components associated with them are allowed. Surgical stapling instrument 10 includes opposing lower and upper jaws 52, 54, while lower jaw 52 includes a channel 56 for brackets (FIG. 4), configured to support a cartridge with brackets 60, while the upper jaw 54 has an inner surface 58, which faces the lower branch 52 and which is adapted to work as a stop member to facilitate pushing the brackets 70 out of the cassette 60 with the brackets. The branches 52, 54 are arranged to move relative to each other to clamp tissue or other objects located between them, and the components of the activation system can be arranged to pass at least part of the end effector 50 to push the staples into the clamped tissue. In various embodiments, the knife blade 81 may be connected to an activation system to cut the fabric during the stitching procedure. At least one of the opposite lower and upper branches 52, 54 will be movable relative to the other lower and upper branches 52, 54. At least one of the opposite lower and upper branches 52, 54 may be fixed or fixed in some other way. . In some embodiments, the implementation of both the lower and upper opposite branches 52, 54 will be movable.

The action of the end effector 50 and can be started with a signal from the doctor on the node 12 of the handle. The handle assembly 12 may have a variety of different configurations designed to control and operate an end effector 50 connected to it. In the illustrated embodiment, the handle assembly 12 has a pistol-type case 18 with various mechanical and / or electrical components housed therein to control various characteristics tool. For example, the handle assembly 12 may include a knob 26 located near its distal end 12d, which may contribute to the rotation of the barrel 14 and / or end effector 50 relative to the handle assembly 12 around the longitudinal axis L of the barrel 14. The handle assembly 12 may further include clamping components in as part of a clamping system, driven by a clamping trigger 22, and activating components as part of an activation system bored mechanism 24. The clamping and activating trigger mechanisms 22, 24 can be deflected to an open position relative to the fixed handle 20, for example by means of a torsion spring. The movement of the clamping trigger mechanism 22 towards the fixed handle 20 can actuate the clamping system described below, which can cause the jaws 52, 54 to close towards each other and thus clamp the fabric between them. The movement of the activating trigger mechanism 24 may activate the activating system described below, which may cause the brackets to be pushed out of the cassette with brackets located in it, and / or extension of the knife blade 81 for cutting the tissue trapped between the branches 52, 54. it will be understood that various configurations of components can be applied to an activation system, mechanical, hydraulic, pneumatic, electromechanical, robotized, or any other, to push out the brackets and / or p ssecheniya tissue, and thus their detailed explanation is not required.

As shown in more detail in FIG. 4, the end effector 50 of the illustrated embodiment is a surgical stitching tool comprising a lower branch 52, which serves as a cassette unit or carrier, and an opposite upper branch 54, which serves as a stop member. A cassette with brackets 60, having many brackets 70 in it, is supported by a tray with brackets 57, which in turn is supported inside the channel of the cassette of the lower branch 52. The upper branch 54 has many brackets forming the recesses 66 (FIG. 11), each of which is located above corresponding brackets from the set of brackets 70 contained within cassette 60 with brackets. The upper branch 54 can be connected to the lower branch 52 in various ways, although in the illustrated embodiment the upper branch 54 has a proximal rotary end 54p, which is rotatably taken inside the proximal end 56p channel 56 for brackets directly distal to the place of its engagement with the barrel 14. When the upper The branch 54 rotates downward, the upper branch 54 moves the surface of the stop element 58, and the forming brackets of the recess 66 formed on it move in the direction of the opposite cassette with the brackets kami 60.

Various clamping components can be used to open and close the branches 52, 54 to selectively clamp the fabric between them. In the illustrated embodiment, the pivoting end 54p of the upper jaw 54 includes a closing member 54c disposed distally to its pivotal attachment with the channel 56 for the staples. Thus, the closing tube 82, the distal end of which includes a horseshoe-shaped hole 82a, which engages this closing element 54c, selectively transmits an opening movement to the upper branch 54 during proximal longitudinal movement and transmits the closing movement to the upper branch 54 during the distal longitudinal movement of the closing pipe 82 as a result of the clamping trigger 22. It will be understood by a person skilled in the art that the opening and closing of the end effector 50 can be performed l through the relative movement of the 52 branches relative to the upper branch 54, the relative movement of the upper branches 54 relative to the lower branches 52 or through the movement of both branches 52, 54 relative to each other.

The activating components of the illustrated embodiment may include an activating bar 84, as shown in FIG. 5, having a three-horned element 86 at its distal end. The activating bar 84 is enclosed inside the shaft 14, for example, in the longitudinal slit 14s of the activating bar 14, and is guided by an activating movement of the handle 12. The actuation of the activating trigger 24 can affect the distal movement of the three-low element 86 through at least part of the end effector 50 to thereby activate the brackets 70 contained within the cartridge 60 with the brackets. In the illustrated embodiment, the guide elements 85 protruding from the distal end of the three-leg element 86 can engage the wedge-shaped sled 90, which in turn can push the ejector of the brackets 92 up through the cavities 68 with the brackets formed in the cassette 60 with the brackets. The upward movement of the ejector brackets 92 applies an upwardly directed relative force of each set of brackets 70 inside the cassette 60 so as to push the brackets 70 upwardly against the surface of the stop element 58 of the upper branch 54 and to create molded brackets 70 '.

In addition to ensuring the activation of the brackets, the three-horned element 86 can be made with the possibility of facilitating the closing of the branches 52, 54, the distance of the upper branch 54 from the cassette with the brackets 60 and / or dissection of the tissue trapped between the branches 52, 54. a pair of lower pins 89 can engage one or both of the upper and lower branches 52, 54 to compress the branches 52, 54 towards each other, as the activating bar 84 extends through the end effector 50. At the same time, the knife 81 extending between the upper and lower pin E 87 89 captured between the jaws 52, 54 may be configured to cut tissue.

When used, surgical stapling instrument 10 may be placed in a cannula or port and located within the surgical field. The tissue to be cut and stapled with brackets can be placed between the branches 52, 54 of the surgical stapling instrument 10. The tools of the stapling instrument 10 can be moved as desired by the doctor to achieve the desired location of the branches 52, 54 within the surgical field and tissues relative to the branches 52, 54 After reaching the appropriate location, the clamping trigger 22 can be pulled in the direction of the fixed handle 20 to actuate the clamping system. The trigger mechanism 22 may actuate the components of the clamping system so that the closing tube 82 extends in the distal direction through at least a portion of the barrel 14 to ensure that at least one of the branches 52, 54 is closed in the direction of the other to clamp the fabric located between them. Further, the trigger mechanism 24 can be pulled in the direction of the fixed handle 20 to actuate the components of the activating system, so that the activating bar 84 and / or the three-legged element 86 are distally advanced at least through part of the end effector 50 to ensure activation of the brackets 70 and optional for dissection of tissue, captured between the branches 52, 54.

Another embodiment of the surgical instrument 100 is illustrated in FIG. 6. Like the surgical instrument 10, the surgical instrument 100 includes a handle assembly 112 with a barrel 114 extending distally from it and having an end effector 150 at its distal end for treating tissue. The upper and lower branches 154, 152 of the end effector 150 can be made to grip the fabric between them, stitch the fabric by activating the brackets from the cassette 160 located on the lower branch 154, and / or to provide an incision in the fabric. In this embodiment, the attachment portion 116 at the proximal end of the barrel 114 may be configured to provide a detachable connection of the barrel 114 and the end effector 150 to the handle assembly 112. In particular, the connecting means 125 of the attachment section 116 may be connected to the associated connecting means 123 of the handle assembly 112. Connection means 123, 125 can be configured to connect with each other, for example, via snap-on connection, bayonet connection, etc., although any number of paired connection tools and any type of connection can be used to detachably connect the barrel 114 to the handle assembly 112 . Although the entire trunk 114 in the illustrated embodiment is configured to detach from the handle assembly 112, in some embodiments, the attachment section 116 may be configured to detach only from the distal portion of the trunk 114. The detachable connection of the trunk 114 and / or end effector 150 may provide selectively attaching the desired end effector 150 for a particular procedure, and / or for reusing the handle assembly 112 for a variety of different procedures.

The handle assembly 112 may have one or more means for controlling and operating the end effector 150. As a non-limiting example, the rotary knob 126 mounted on the distal end of the handle assembly 112 may assist the shaft 114 and / or end effector 150 to rotate relative to the handle assembly 112 . The handle assembly 112 may further include clamping components as part of a clamping system, actuated by the trigger mechanism 122, and activating components as part of the activation system, which may also be actuated by the trigger mechanism 122. Thus, in some embodiments, the movement of the trigger mechanism 122 in the direction of the fixed handle 120 through the first range of motion can actuate the clamping components to ensure that the opposing clamp is approaching 152, 154 toward each other to ensure the closed position. Further movement of the trigger mechanism 122 in the direction of the fixed handle 120 through the second range of motion can activate the activating components to push the brackets out of the cassette with the brackets 160 and / or extend the knife to cut the tissue caught between the branches 152, 154.

Another exemplary embodiment of a surgical instrument 200 is shown in FIG. 7. Similar to surgical instruments 10 and 100, surgical instrument 200 includes a handle assembly 212 with a barrel 214 extending distally from it and having an end effector 250 at its distal end for treating tissue. The end effector 250 may include a cassette assembly 252 and an abutment member 254, each of which has a surface in contact with the fabric 260p, 260d, which is substantially circular in shape. The cassette assembly 252 and the stop member 254 may be interconnected by means of a barrel 262 extending from the stop member 254 to the handle assembly 212 of the stapling instrument 200, and control of the drive 222 on the handle assembly 220 may retract and extend the stem 262 to move the stop member 254 relative to the assembly cassettes 252. In one embodiment, the stem 262 may be formed by the first and second parts (not shown) made with the possibility of making a detachable connection with each other ensuring the detachment of the stop element 254 from the node Cassette 252, which provides greater flexibility in the placement of anvil member 254 and cartridge assembly 252 in the body. For example, the first part of the barrel may be placed inside the node of the cassette 252 and extend distally outside the node of the cassette 252, ending in a distal means of connection. The second part of the barrel 214 may be placed inside the stop element 254 and it passes proximally outside the node of the cartridge 252, ending with the proximal connection means. When applied, the proximal and distal means of connection can be interconnected to ensure the movement of the stop element 254 and the node of the cassette 252 relative to each other. The stop member 254 and the cassette assembly 252 may perform various functions and may be configured to grip the tissue therebetween, stitch the fabric by activating brackets from the cassette assembly 252 and / or may provide an incision in the tissue. Typically, a cassette containing brackets may be placed in the cassette assembly 252, and it may push the brackets relative to the stop member 254 to form a round brace around the circumference of the body's tubular organ.

The knot 212 of the handle of the stapling instrument 200 may have various actuators housed therein that can control the movement of the stapling instrument. For example, the handle assembly 212 may have a rotary knob 226 placed on it to facilitate placement of the end effector 250 through rotation, and / or a trigger mechanism 222 for actuating the end effector 250. Movement of the trigger mechanism 222 through the first range of motion may activate clamping system components for branch closure, i.e. the movement of the stop element 254 in the direction of the cassette assembly 252. The movement of the trigger mechanism 222 through the second range of motion can actuate components of the activating system to push the brackets out of the cassette 252 of the cartridge with brackets and / or to extend the knife to cut the tissue trapped 252 and the stop element 254.

The illustrated embodiments of surgical stapling instruments 10, 100, and 200 present only a few different configurations, as well as related uses that can be used in conjunction with the disclosures of the invention presented herein. Although all illustrated embodiments are designed to employ minimally invasive procedures, it should be understood that instruments made to be used in open surgical procedures, for example, open linear suturing instruments, as described in US Pat. No. 8,317,070, can be used in conjunction with disclosures presented in this document. A more detailed description of the illustrated embodiments, as well as additional illustrative embodiments of surgical stapling instruments, their components and related uses, which can be used in accordance with the present disclosure, include devices, components and methods presented in US Patent Application Publication No. 2013/0256377, U.S. Patent No. 8393514, U.S. Patent No. 8317070, U.S. Patent No. 7,143,925, U.S. Patent Application Serial No. 14/074884, entitled “Sealing Materials for Use in Surgical Procedures”, filed on November 8, 2013, US patent application serial number 14/074810, entitled "Hybrid Adjunct Materials for Use in Surgical Stapling" and filed November 8, 2013, US patent application serial number 14/075438, entitled "Positively Charged Implantable Materials and Method of Forming the Same "and filed on November 8, 2013, with a US patent application with serial number 14/075459, entitled" Tissue Ingrowth Materials and Method of Using the Same "filed on November 8, 2013, in the US patent application with serial number 14/074902, entitled "Hybrid Adjunct Materials for Use in Surgical Stapling" and filed November 8, 2013, US patent application with serial No. 14/226142, entitled «Surgical Instrument Comprising a Sensor System» and filed on March 26, 2014, each of which is incorporated herein by reference in its entirety.

VARIATIONS OF THE END EFFECTOR

The end effector of the surgical stapling instruments described herein may have one or more means for controlling the amount of compression applied to the tissue captured by the end effector. In some embodiments, the implementation of the end effector can be performed with the possibility of the formation of the desired profile of compression in the tissue captured by them, for example, a profile that facilitates minimizing bleeding, rupture and / or leakage of the tissue to be treated. As a non-limiting example, the necessary tissue compression profile can be obtained using variations in the gap between the upper and lower branches of the end effector and / or variations in orientation, size and / or shape of brackets applied relative to the tissue by means of an end effector. As described in detail in this document, the auxiliary material (s) used in combination with such an end effector can be designed to help create the necessary tissue compression profile and / or accommodate the means used to create the necessary fabric compression profile.

Any of these variations described in this document can be applied separately or together with providing the necessary tissue compression profile. Although the illustrative end effectors and their components are described in combination with a specific surgical instrument, for example, instruments 10, 100 and 200, it should be understood that the end effectors and their components can be configured to be used with other embodiments of surgical instruments, described in this document.

In some embodiments, the implementation of the cartridge with brackets, located inside the end effector of the surgical stapling instrument, may have a first part made with the possibility of squeezing the tissue captured by the end effector more than the second part, if the end effector is in the closed position. The first part of the cassette can be placed in the longitudinal direction and / or in the lateral direction with the formation of the required compression gradient. For example, as shown in FIG. 4 and 8, the staple cassette 60 may have a stepped tissue contact surface. In particular, the cassette 60 may have an inner tissue-contacting surface 62 and an outer tissue-contacting surface 64, which extends upward to a greater height than the inner tissue-contacting surface 62. Thus, when the upper jaw 54 is in the closed position in the near approximation to the cassette 60, the surface 58 of the retaining element can be made with the possibility of compressing the outer surfaces 64 larger than the inner surface 62, due to the greater height of the outer surfaces 64. In some cases In particular, when the fabric located between the surface 58 of the stop element and the cassette 60 has a constant or at least substantially constant thickness, the pressure generated in the fabric may be greater on the outer surface of the end clamp 50 than on the inside the surface of the end clamp 50. While the compression gradient formed by the cassette 60 varies in steps, it will be clear to a person skilled in the art that a gradual compression gradient can be formed in the fabric with a gradual the height of the different parts of the cassette 60. It should also be understood that the compression gradient can be formed by variations in the height of the surface 58 of the thrust element, alone or in combination with variations in the height of the cassette 60, and that the height variations can be located in the lateral and / or longitudinal end effector 50.

In some embodiments, the implementation of one or more auxiliary materials attached to the end effector of a surgical stapling instrument can be used to create the desired compression profile in the tissue captured by the end effector. Referring to FIG. 9, a compressible implantable staple cartridge 360 can be obtained from one or more auxiliary materials described herein and can be configured to seal within the end effector of a surgical instrument, for example, the end effector 350. The cassette 360 may have a height that decreases from the greatest height H1 at its distal end 360d to the lowest height H2 at its proximal end 360p. Thus, when the upper branch 354 of the end effector 350 is in the closed position in close proximity to the cassette 360, the upper branch 354 of the end effector 350 can be adapted to compress the distal end 360d more than the proximal end 360p. Although the compression gradient formed in the captured tissue by the cassette 360 linearly decreases from the distal end 360d to the proximal end 360p, one skilled in the art will recognize that any compression gradient can be formed by various forms of the cassette 360. At least in In one embodiment, the thickness of the cassette 360 may vary across its width, like a cassette 360.

In some embodiments, the implementation of the brackets contained within the cassette with end effector brackets can be made with the possibility of the formation of the required compression profile in the tissue captured by the brackets. The required compression profile can be formed in the fabric stapled with brackets, for example, in cases where the brackets inside the cassette with brackets have different heights of unformed brackets. As shown in FIG. 10, the unformed height H of the illustrative bracket 70 can be measured from the base 74 of the bracket 70 to the top, or the top, of the legs 72a, 72b of the bracket 70. Referring to FIG. 11, which illustrates a cross section of the end effector 350, the first bracket group 370a may have a first bracket height H1, which is taller than the second bracket height H2 of the second bracket group 370b. The first group of brackets 370a may be located in the first part of the cassette with brackets 360, for example, in the outer part, the second group of brackets 370b may be located in the second part of the cassette with brackets 360, for example, in the internal part. In the illustrated embodiment, the cassette 360 and, therefore, the compression gradient, can be made symmetrically positioned relative to the tray 367, made with the possibility of passing through it a cutting tool, for example, three-legged element 86. The specialist in this field will understand that the first and second groups of brackets 370a, 370b can be arranged in the form of any pattern and can be located in the lateral and / or longitudinal direction along the cassette 360. In certain embodiments, I can use a variety of bracket groups, each of which has a different height of unformed brackets. In at least one such embodiment, a third group having an intermediate height of brackets may be located in the cassette between the first group of brackets and the second group of brackets. In various embodiments of the present invention, each bracket in a row of brackets in a suture bracket can include a different height of the bracket. In at least one embodiment of the present invention, the highest bracket in the row of brackets can be placed on the first end of the row of brackets and the shortest bracket can be placed on the opposite end of the row of brackets. In at least one such embodiment of the present invention, brackets placed between high and short brackets can be set so that the height of the bracket, for example, decreases from the high bracket to the short bracket.

Similarly, the brackets inside the cassette with brackets can have different head widths to form the desired compression profile in the fabric to be stapled. As shown in FIG. 10, the width W of the head of the illustrative bracket 70 can be measured from one side of the base 74 of the bracket 70 to the opposite side. Similar to the above-described variations of the height H of the bracket, variations of the width W of the bracket can be located throughout the cartridge with brackets to form a plurality of groups of brackets distributed in the longitudinal and / or lateral direction throughout the cartridge. As a non-limiting example, FIG. 12 illustrates a cassette with brackets 260 for use with a surgical instrument 200 and which includes brackets 270 with different values of the width W of the head. A cassette with brackets 260 holds three groups of brackets 270a, 270b, 270c, each of which has different widths W1, W2 and W3, respectively, although any number of groups of brackets is possible. As shown, groups of brackets 270a, 270b, 270c can be mounted in cylindrical rows, with brackets 270c having the greatest width W1 located on the outer edge of the cassette 260, and brackets 270a having the smallest width W3 located on the inner edge of the cassette 260. In other embodiments, brackets having a greater width of the head may be located near the inner edge of the cassette, and brackets having a smaller width of the head may be located near the outer edge of the cassette. In the following embodiments, the brackets along the same row may have different head widths.

Additionally or alternatively, the formation of the required tissue compression profile is possible by forming different values of the formed (final) height of the brackets. FIG. 13 shows an exemplary embodiment of the lines of formed brackets 470 ′ installed using a surgical stapling instrument described herein and configured to use brackets 470 ′ having different values of the generated height as well as cutting the fabric so as to form a cutting line 494. As shown in FIG. 13, the values of the formed height F1 of the first group of brackets 470a ′ in the first row, which are at the farthest distance from the cutting line 494, are larger than the values of the formed height F3 of the third group of brackets 470c ′ in the third row which is closest to the line 494 cut. The second group of brackets 470b ′ in the second row, which is formed between the first and third rows, may have brackets 470b ′ with a formed height F2, which is intermediate between the values of height F1, F3. In other embodiments, the implementation of the values of the formed height of the brackets may decrease from the closest to the center of the row to the most distant from the center of the row. In the following embodiments, the values of the formed height of the brackets in one row may increase or decrease from the bracket to the bracket.

Referring again to FIG. 11, differences in the height values of the formed brackets can be implemented, for example, by changing the distance forming the bracket. element when the upper branch 354 is in the closed position. In one embodiment, for example, the first bracket-forming distance A1 is different from the second bracket-forming distance A2. Since the forming distance A1 is larger than the forming distance A2, brackets 370a are not compressed as brackets 370b, which can change the values of the formed height of brackets 370a, 370b. In particular, large amounts of compression, corresponding to shorter forming distances, can provide brackets with smaller formed (finite) height values. It should be understood that such results can be implemented in any desired way.

Different gradients of tissue compression can be obtained by means of orientation patterns of brackets inside the cassette with brackets, for example, by the patterns illustrated in FIG. 14 and 15. In the embodiment shown in FIG. 14, a bracket with brackets 560 may include at least one first cavity 568a with brackets and at least one second cavity 568b with brackets for accommodating brackets 570. The first cavity 568a may be located on the first lateral side 563 of the cartridge 560 and the second cavity 568b may be located on the second lateral side 565 of the cartridge 560, with the first and second lateral sides 563, 565 separated by a tray 567, configured to pass a cutting tool through it, for example, a three-element 86. The first cavity 568a can define a first longitudinal axis 569a and the second cavity 568b may define a second longitudinal axis 569b. In the illustrated embodiment, the first axis 569a is perpendicular or substantially perpendicular to the second axis 569b. In other embodiments, the first axis 569a may extend transversely relative to the second axis 569b, such that the axes 569a, 569b may form an acute or obtuse angle between them. In the following embodiments, the first axis 569a may be parallel, or substantially parallel, to the second axis 569b. In some embodiments, the implementation of at least part of the cavities 568a, 568b with brackets can overlap in such a way that the brackets 570 in them can be closed between themselves during formation. The cassette 560 may have a plurality of each of the first and second cavities 568a, 568b, which may be arranged in any pattern on the first and second sides 563, 565 of the cassette 560, for example, in rows extending along both sides 563, 565 of the cassette 560 along the longitudinal the Lc axes of the cassette 560. The brackets 570 placed inside the cavities 568a, 568b are implanted inside the tissue in the form of a pattern defined by the orientation and placement of the cavities 568a, 568b. Cassette 560, for example, may be used to implant brackets 570 having different orientations of brackets 570 on opposite sides of a notch line formed by a surgical instrument comprising cassette 560.

In other embodiments, for example, in the embodiment of the cassette 660 illustrated in FIG. 15, cavities 668a and 668b with brackets having different orientations can be placed on one side of the cassette 660. As shown in FIG. 15, the axis 669a of the first cavity 668a with brackets is perpendicular, or substantially perpendicular, to the axis 669b of the second cavity 668b with brackets, both of which are located on each of the first and second side areas 663, 665 of the cartridge 660. In other embodiments, the axes 669a, 669b may form a sharp or obtuse angle between them, or may be parallel to each other. A plurality of first and second cavities 668a, 668b may be aligned in adjacent rows along the longitudinal axis Lc ′ of cassette 660 on each of the first and second sides 663, 665 of cassette 660. In this embodiment, brackets 670 placed inside cavities 668a, 668b may implanted into tissue in the form of a symmetrical pattern near the incision line formed by a surgical instrument containing a 660 cassette. A more detailed description of the bracket patterns, as well as additional embodiments of such patterns, can be found in US Patent Application Publication No. 2011/0192882, incorporated herein by reference in its entirety.

Illustrative compositions for auxiliary materials

Regardless of the configuration of the surgical instrument, the present invention contemplates the use of implantable materials, for example, synthetic and / or biological materials, collectively referred to as "auxiliary materials", in combination with the operation of the instrument. As shown in FIG. 16, the end effector 50 may comprise at least one part of the auxiliary material 30 located between the lower and upper elements of the junction 52, 54, and it can be held to be detachable in one of the channel 56 with the brackets and / or the surface of the abutment element 58 During application, the auxiliary material 30 and the patient’s tissue can be gripped by brackets 70 when pushing the brackets 70 out. Then the auxiliary material 30 can be separated from the surgical stapling instrument and can be left in the patient’s body for echenii stapling instrument from the patient. Illustrative devices and methods for attaching one or more auxiliary materials to an end effector of a surgical instrument can be found in US Patent Application Publication No. 2013/0256377 and US Patent Application Publication No. 2013/0153641, incorporated herein by reference in their entirety.

The auxiliary material used in conjunction with the disclosures of the invention provided herein may have any number of configurations and properties. As a rule, they can be made of a bioabsorbable material, a biofragmentable material and / or a material capable of breaking down, for example, so that the auxiliary material can dissolve, dissolve, break up into fragments and / or collapse during the healing process. In at least one embodiment, the auxiliary material may be adapted to disintegrate over time with the formation of a gel, for example, tissue glue, to facilitate wound healing. In other embodiments, the implementation of the auxiliary material may, for example, include a therapeutic drug that can be made with the possibility of release within a certain period of time, promoting healing of the tissue. In additional various embodiments, the implementation of the auxiliary materials may contain, for example, non-absorbable materials and / or materials that cannot be split.

Some particularly advantageous auxiliary materials may include porous polymeric scaffolds, which can be made with the possibility of splitting, for example, under the action of water, in such a way that water affects the bond of the polymer material. The disintegrating material can be made with the possibility of gel formation at the wound site with the coating of the wounded tissue, for example, wounded soft tissue, which may contribute to compression, compaction and / or the general formation of the environment at the wound site that provides healing of the tissue. In particular, such decaying materials ensure the transformation of the fabric itself into a load bearing component. In some embodiments, the disintegrating material may include chemoattractant agents that attract compounds for natural healing to the wound site. Polymer scaffolds can be made with the possibility of having the necessary degree of disintegration, for example, within a few minutes to hours after attaching to the fabric, in order to facilitate the healing process almost immediately after attachment. For more details regarding the porous polymer scaffolds described in this document, see Q. Chen et al., Progress in Polymer Science 38 (2013) 584-671, incorporated herein by reference in its entirety.

In some embodiments, the implementation of the porous polymer framework described in this document can be physically crosslinked, which can ensure the formation of the polymer in various complex three-dimensional forms, for example, fibers, sheets, films, etc., having the necessary porosity, the ratio of area to volume and mechanical properties. The framework can be molded into the desired shape by several methods, for example, by extrusion, wet molding, electrotorture, thermally induced phase separation (TIPS), salt leaching / lyophilization, etc. If the framework is formed into a film or sheet, the film or sheet may have any desired thickness, for example, in the range from about 50 to 750 microns or in the range from about 1 to 3 mm, depending on the application required.

One embodiment of the porous polymeric framework includes several layers, each of which can perform different wound healing functions. In an illustrative embodiment, the framework comprises three layers. The first layer can be made of polyester urethane urea carbonate (PECUU), the second layer can be made of poly (urethane urea) urea (PEUU) and the third layer can be made of poly (urethane urethane) urea poly (PCUU) lysine triisocyanate (LTI) or hexamethylene diisocyanate (HDI). The person skilled in the art will appreciate that the properties of each layer can be optimized to achieve the desired results and characteristics. In some embodiments, the implementation of the necessary properties of the frame can be achieved by mixing or copolymerization of the material of the third layer or copolymerization with various polymers or copolymers. As non-limiting examples, the third layer material can be mixed with a polyester copolymer, for example, polycaprolactone (PCL), polyglycolic acid PGA, poly (D, L-lactic acid) (PDLLA), PGA and / or polyethylene glycol (PEG). If the material of the third layer is mixed with both the polyester copolymer and the PEG, then the ratio of the polyester to the PEG in the third layer may be approximately 50:50. In another illustrative embodiment, PCL may be present in the range of approximately 60-70% w / v, PGA may be present in the range of approximately 20-30% w / v, PEG may be present in the range of approximately 50% w / v, and PDLLA may be present in the range about 10% weight / volume.

Three-layer film can be made with the possibility of decomposition almost immediately when attached to the fabric, for example, within about 1-2 hours after attachment, despite the fact that each of the three layers can be made with the possibility of decomposition otherwise providing different benefits of treatment. The order, number and thickness of each of the layers can vary and can be adapted to provide the necessary decomposition and / or compression ratios. In some embodiments, the first, second, and third layers may be formed on the surface of the base material or substrate, for example, on the PCL surface, which may be adapted to facilitate mechanical compression of the wounded tissue.

Another exemplary embodiment of a porous polymeric framework can be synthesized from a polyhydroxyalkanoate (PHA). In an exemplary embodiment, the PHA can be obtained naturally from various microorganisms, such as Gram-negative or Gram-positive bacteria, or it may be synthesized, for example, like getting Biopol ^®, available from Zeneca, London, UK. Because PHA dissolves very quickly, scaffolds made from PHA can begin to decompose within 20-30 minutes after they are attached to the fabric through contact with heat and / or water. If the framework on the basis of PHA has a greater molecular weight, the decomposition time may be greater, for example, in the range from about 30 minutes to about 10 hours. PHA can be formed into a very thin film, for example, a film with a thickness of less than 0.1 mm, for example, in the range from 50 to 750 microns. In some embodiments, the implementation of PHA can be copolymerized and / or mixed with one or more additional materials. As a non-limiting example, PHA can be copolymerized with hydroxyl valerate (HV), hydroxybutyrate (HB) and / or hydroxyhexanoate (HH), which can reduce the level of crystallinity and / or brittleness of PHA. In other embodiments, the implementation of PHA can be mixed with one or more thermoplastic, for example, poly (lactic acid) (PLA), PGA, PCL, starch, etc. For the correction of molecular weight and the resulting mechanical properties of the frame. In certain aspects, one or more polymers may be a thermoplastic polymer.

In other embodiments, the implementation of the framework can be synthesized from poly (polyol sebacina) (PPS), for example, from poly (glycerol-sebacina) (PGS). Such scaffolds may be particularly biocompatible and may provide the added benefit of reducing the risk of infection in addition to accelerating healing. Other exemplary embodiments can be synthesized from xylitol-based elastomers, for example, polyxylitesebacates (PXS), which can provide structural stability for a period required from a clinical point of view and / or can enter the metabolic pathway slowly without ensuring rapid fluctuations in blood glucose levels. Frames made of PXS can be molded into a thicker film to thereby provide greater compression at the wound site, and they can be made to decompose within a range from about 10 hours to 8 days after attachment. Yet another illustrative embodiments can be synthesized from poly (glycerol sebacate-co-acrylate) (PGSA), which can cause tissue to germinate in the skeleton, especially when formed into fiber, and / or can serve as an antibacterial agent. PGSA scaffolds may be suitable as a substitute for conventional surgical sutures and staples, and / or can serve as a waterproof tissue adhesive for anastomosis of a hollow organ (for example, ducts, intestines, etc.), 2D perforated skin grafts (for example, in the treatment of hernias, ulcers, burns, etc.) and / or wound dressings (for example, hemostatic patches, etc.). PGSA can be combined with glycerin, which can provide longer in situ preservation of the scaffold, for example up to 20 days.

In yet another embodiment, the skeleton may be made of poly (ε-caprolactone) (PCL), which can be mixed with silk fibroin (SF) and which can be molded into a very thin film. A mixture of PCL / SF may have extremely biocompatible properties and / or may improve the attachment and / or proliferation of cells to the scaffold. For example, when implanted onto a tissue, the scaffold may release fibroin into the tissue in order to ensure faster healing, almost instantaneous hemostasis, and / or attracting fibroblasts in large quantities. The PCL component can further facilitate the healing process by providing mechanical compression of the wounded tissue. A higher PCL content can provide better mechanical properties, while a higher SF content can provide better decomposition properties. Typically, the PCL content may be in the range of from about 50 to 90% w / v and the SF content may be in the range from about 10 to 50% w / v. More details on the properties and methods for making scaffolds made from PCL and SF can be found in Jun Sik Lim et al., Fabrication Poly (epsilon-caprolactone) / Silk Fibroin Blend Nanofibrous Scaffold, Biopolymers 97: 265-275 (2012 ), incorporated herein by reference in its entirety.

In the following embodiments, the framework may include PCL coated with gelatin. The frame may be located in one or several layers, for example, if PCL acts as a substrate. PCL can function to increase the mechanical strength of the scaffold and / or can maintain fibroblast adhesion and cell proliferation. More details on the properties and methods of making scaffolds made from gelatin-coated PCL can be found in coaxial electrospinning, J. Biomed Mater Res 83A: 372 -382 (2007), incorporated herein by reference in its entirety.

Table 1 below sets out illustrative molecular weight ranges, approximate absorption times, and average film sizes made from the above porous polymer framework materials. The person skilled in the art will understand that the ranges shown in Table 1 are not intended to be limited, and that the molecular weight of any of the polymers described herein can be changed to obtain the necessary decomposition properties.

Table 1

Film Average molecular weight in Daltons Approximate absorption times Average thickness Average length Average
width Polyester carbonate urethane
urea (PECUU) 5,000 to 80,000 14-60 days 0.01-0.03 mm (10 µm to 1 mil) 25.4-100 mm 10.3-12.7 mm Complex poly (urethane ester) urea (PEUU) 5,000 to 80,000 14-60 days 0.01-0.03 mm (10 µm to 1 mil) 25.4-100 mm 10.3-12.7 mm Poly (urethane carbonate) urea (PCUU) 10,000–200,000 (preferably 15,000–50,000) 14-60 days 0.1–0.03 mm (100 μm to 1 mil) 25.4-100 mm 10.3-12.7 mm Polyhydroxyalkanoate
(PHA) 2.107 × 1029-2,589 × 1029 7-60 days 0.1–0.03 mm (100 μm to 1 mil) 25.4-100 mm 10.3-12.7 mm Poly (polyol sebacate) (PPS) 89,000 and 124,000 7-60 days 0.1–0.03 mm (100 μm to 1 mil) 25.4-100 mm 10.3-12.7 mm Polyxyl sebacate (PXSʹs) 1.47 × 1027-3.73 × 1027 7-60 days 0.1–0.03 mm (100 μm to 1 mil) 25.4-100 mm 10.3-12.7 mm Poly (glycerol sebacate-co-acrylate) (PGSA) 5.8 × 1026-7.5 × 1026 7-60 days 0.01-0.03 mm (10 µm to 1 mil) 25.4-100 mm 10.3-12.7 mm Poly (ε-caprolactone); silk fibroin; frame (PCL / SF) mixture PCL / SF (50/50) 25,000-325,000 (sf)
4.21 × 1028-4.81 × 1028 (PCL) 21-60 days (SF)
2-3 years (PCL) 0.01-0.03 mm (10 µm to 1 mil) 25.4-100 mm 10.3-12.7 mm Gelatin-coated PCL (poly (ε-caprolactone) 3.01 × 1028-1.98 × 1029 (gelatin)
4.21 × 1028-4.81 × 1028 (PCL) 7 days (gelatin)
2-3 years (PCL) 0.1–0.03 mm (100 μm to 1 mil) 25.4-100 mm 10.3-12.7 mm

Other suitable auxiliary materials may include absorbable polyurethanes, for example, polyurethanes formed from aromatically absorbed isocyanates, which may be similar to methylene bis (phenyl isocyanate) (MDI) and chain extender diols. Absorbable polyurethanes can be made to hydrolytically decompose to safe and biocompatible products during hydrolysis. Nonlimiting examples of hydrolyzed aromatic isocyanates that may be used to form the absorbed polyurethanes include glycolate diisocyanate, caprolactone-diisocyanate, glycolate, ethylene glycol, glycolate, diethylene glycolate, lactate, diethylene glycol lactate, triple ester of glycolic acid with trimetilpropanom and quaternary glycolic ester with pentaerythrinol.

Other particularly advantageous supporting materials that can be used in conjunction with the disclosures presented in this document are those that form the multi-layer dressings disclosed in US Patent Application Publication No. 2006/0257458, incorporated herein in its entirety, which Especially suitable for the absorption and retention of liquids under compression, for example when using brackets Other illustrative non-limiting examples of synthetic materials which can be used in conjunction with the descriptions given herein, e.g., as a support, include a biodegradable synthetic absorbable polymer such as polydioxanone film on the market under the trademark PDS ^®, or film on the basis of polyglycerol sebacate (PGS), or other bioabsorbable films formed from PGA (polyglycolic acid and its various forms, marketed under the trade mark Oh Vicryl, Dexon and / or Neoveil), PCL (polycaprolactone), PLA or PLLA (polylactic acid), PHA (polyhydroxyalkanoate), PGCL (polymelecapron 25, marketed under the brand name Monocryl), PANACRYL (Ethicon, Inc., Somerville, New Jersey, USA), polyglactin 910, polyglyconate, PGA / TMC (trimethylene carbonate polyglycolide marketed under the brand name Biosyn), polyhydroxybutyrate (PHB), polyvinylpyrrolidone (PVP), poly (vinyl alcohol) (PVA) , polydioxanone (PDO) and its various forms (for example, sold under the trademark PDS) or any copolymerization mixture on from the above. Mixtures and / or copolymerization of any of the above materials can be adapted to provide the required molecular weight and / or decomposition rate.

Some non-limiting examples of biological materials obtained that can be used in combination with those disclosed herein, for example, as sealing material include platelet-poor plasma (PPP), platelet-rich plasma (PRP), starch, chitosan, alginate, fibrin, thrombin , polysaccharide, cellulose, collagen, bovine collagen, bovine pericardium, gelatin-resorcin-formalin binder, oxidized regenerated cellulose, regenerated cellulose, clam-based binder ov, poly (amino acid), agarose, polyetheretherketones, amylose, hyaluronan, hyaluronic acid, whey protein, cellulose gum, starch, gelatin, silk, Progel ^® , available from Davol Inc., Warwick, Rhode Island, TachoSil ^® , available from Baxter, Dirfield, Illinois, or other material that is suitable for mixing with biological material and introducing into a wound or area of injury, including combinations of materials, or any material that is obvious to those skilled in the art, taking into account those disclosed in this document. Biological materials can be obtained from a number of sources, including from a patient who is implanted with biological material, a person who is not a patient who is implanted with biological material, or other animals.

Additional descriptions relating to synthetic or polymeric materials and biological materials that can be used in conjunction with the descriptions presented in this document are presented in US Pat. No. 7,772,352, PCT application publication WO 2014/016819, in US patent application No. 2006/0257458 in application for US patent No. 2012/0080335, in application for US patent No. 2012/0083835, in application for US patent No. 2013/0256372, in application for US patent No. 2013/0256365, in application for US patent No. 2013/0256376 , in the application for US patent No. 13/710931, entitled "Electrosurgical End Effector with Tissue Tacking Features" and filed th December 11, 2012, in US patent application number 13/763192, entitled «Multiple Thickness Implantable Layers for Surgical Stapling Devices» and filed February 8, 2013, each of which is incorporated herein by reference in its entirety.

AUXILIARY MATERIALS WITH MEANS TO RELAX TENSION

The tissue auxiliary material may have various configurations, but, as a rule, it may be configured to contact with the fabric, while the fabric is sandwiched between the cassette assembly and the abutment member of the surgical stapling instrument. One of the advantages of fabric auxiliary materials is their ability to prevent or minimize leakages, such as liquid or gas leaks. Tissue auxiliary materials can perform this function through one or more of the following mechanisms: blocking holes or gaps that occur in places punctured by brackets; restriction of the movement of the tissue around the puncture sites with brackets to prevent an increase in the size of the holes from the brackets and / or prevent tearing of the fabric; and minimizing the strain gradients that occur between the trapped tissue in the line of brackets and loose tissue adjacent to the line of brackets.

In certain aspects, ancillary material may be used to distribute the compressive clamping force across tissues, absorb and retain useful fluids at the treatment site, improve grip brackets and / or facilitate hemostasis. In some embodiments, the implementation of the first part of the auxiliary material may be attached to the cassette assembly, and the second part of the auxiliary material may be attached to the stop element; however, any suitable amount of auxiliary materials may be located in the terminal effector.

The tissue auxiliary material may include various means and may be formed from various materials to facilitate sealing of the fabric in the line of brackets and / or to prevent the formation of stains in the fabric. For example, the tissue auxiliary material may have a central region adapted to be mounted on the fabric and attached to it by means of brackets. The tissue auxiliary material may further include an outer region, also referred to herein as a pterygoid region or pterygoid portion, which may be located outside the line of brackets when the auxiliary material is sewn with brackets to the fabric. The pterygoid may facilitate a more even distribution of tension and / or minimize the tension gradients throughout the tissue as the tissue is deformed or otherwise increased and compressed during normal body functions. In some embodiments, the fabric adhesive can be used in combination with an auxiliary material to facilitate the compaction of the fabric stapled with brackets. Tissue glue can be administered to the patient in the first, liquid state, and it can be made with the possibility of transition to the second, hardened or solid state after a predetermined period of time. If the fabric glue is in the first, liquid state, then the fabric glue can seep into the auxiliary material and / or line of staples and then cure, thus reinforcing the complete compaction of the fabric. The auxiliary material and the fabric adhesive can thus interact to provide a better, more complete sealing of the line of staples than if only fabric auxiliary material or fabric adhesive were used.

Exemplary auxiliary materials having central and pterygoid regions are shown mounted on the fabric in FIG. 17A and 17B. As shown in FIG. 17A, auxiliary material 1000 may include a central portion 1002 for passing brackets through it and a pterygoid portion 1004 adjacent to the central region 1002. The central region 1002 of the auxiliary material 1000 may have a size and shape corresponding to the size and shape of the cassette assembly 52 and / or the stop element (not shown). For example, in FIG. 17A, the auxiliary material 1000 is illustrated having a central region 1002, which corresponds in size and shape to the tissue-contacting surface of the cassette assembly 52. That is, the central region 1002 may be substantially equal in size to the surface in contact with the tissue. The central region 1002 of the auxiliary material 1000 shown in FIG. 17A may have a substantially elongated rectangular shape defined by the proximal and distal edges 1002p, 1002d and the first and second lateral edges 1002a, 1002b. The proximal edge 1002p of the central region 1002 may end with the proximal design feature of the compound 1006 for binding to the distal end 14d of the barrel 14 of the stapling instrument 10. At least two of the remaining three edges of the central region 1002 may include a pterygoid portion 1004 extending around it and forming the perimeter of the auxiliary material 1000. For example, as shown in FIG. 17A, the pterygoid portion 1004 of the auxiliary material 1000 may extend around the first and second lateral edges 1002a, 1002b and may extend distally along the distal edge 1002d of the central region 1002. In one embodiment, the auxiliary material 1000 has such a dimension and position on the cartridge assembly 52 that it is can be separated by cutting tools in a crosslinking tool during use. In fact, the distal region of the pterygoid 1004 is always cut. As shown, the pterygoid portion 1004 may have a modified structure that is different from the structure of the central region 1002. In the illustrated embodiment, the central region 1002 may be substantially solid, for example, a film, and the pterygoid portion 1004 may be a mesh. As shown in FIG. 17B, if the auxiliary material 1000 is stapled to the fabric T, then the central region 1002 may have one or more rows / lines of brackets 1008 passing through it, and the pterygoid 1004 may extend laterally from the brackets 1008. As shown, the auxiliary material 1000, sewn with brackets to fabric T, includes half of the auxiliary material shown in FIG. 17A, since the cutting tool in the stapling tool cuts the fabric when brackets 1008 are installed on it. The cellular pterygoid part 1004 can flex with increasing and compressing tissue and more evenly distributes the tension (or minimizes the tension gradient) over the larger part of the fabric than if the auxiliary material 1000 included only the central region 1002. For example, the winged 1004 can increase and shrink in the direction opposite to the longitudinal axis LC of the central region 1002. This can facilitate the prevention of the formation of pressure points, which can form stains in the fabric stapled after stapling. tricking and shrinking fabric. In certain aspects, the cellular structure may be formed from filaments of the same film material as the central region 1002, passing in a crosswise manner. The longitudinal axis of the half thread L1 can be placed at an angle θ1 of approximately 45 degrees relative to the longitudinal axis LC of the central region 1002, as shown, and the longitudinal axis L2 of the other half of the threads can be positioned at an angle θ2 approximately 45 degrees relative to the longitudinal axis LC of the central region 1002, or may be located at other angles relative to the central region 1002. As will be clear to the person skilled in the art, the pterygoid 1004 of the auxiliary material 1000 may be formed using personal known manufacturing techniques, such as laser cutting or cutting out forms, such as squares, circles, diamonds, from a film to obtain a cellular pterygoid region and a solid central region 1002. Two identical auxiliary materials 1000, 1000 ′ can be attached with brackets to the fabric, as shown in fig. 17B, and in certain aspects, these auxiliary materials 1000, 1000 ′ may essentially be the same in size, shape, and configuration.

Another embodiment of the auxiliary material 1010 is shown in FIG. 18 and also includes the central region and the pterygoid region. In this embodiment, the pterygoid portion 1014 has a plurality of holes 1018 formed therein, which allow the pterygoid portion 1014 to bend with the tissue T while the tissue T is enlarged and compressed. rectangular, etc., and can be located in different areas throughout the pterygoid 1014. In the illustrated embodiment, the holes 1018 are slots arranged in several rows, the rows being essentially parallel ny longitudinal axis LC of the central region 1012. The longitudinal slits 1018 axis may be parallel to the longitudinal axis LS of brackets 1008. The number of longitudinal rows and the number of holes 1018 arranged in each row, may vary. In the illustrated embodiment, the row adjacent to the central region 1012 may have fewer openings 1018 than the row adjacent to the most distal from the center edge 1014a of the pterygoid 1014. For example, the row adjacent to the central region 1012 may have about three openings 1018 formed in it, while the row adjacent to the most distal from the center edge 1014a of the pterygoid portion 1014 may have approximately four holes 1018 formed in it. Thus, the flexibility of the pterygoid portion 1014 may increase from the central region 1012 to the lateral edge and may further enhance the distribution of tension throughout the fabric T.

FIG. 19A and 19B illustrate another embodiment of a fabric aid having wings for distributing tension throughout the fabric. FIG. 19A, auxiliary material 1020 is illustrated having a central region 1022 and a pterygoid region 1024, both of which are formed from multiple layers. As in the previous embodiments, the central region 1022 may have a substantially rectangular shape. The upper layer of material may define a central region 1022 and both regions 1022, 1024 may be formed from a plurality of layers. The central region 1022 may have a substantially rectangular shape, but may be formed in other ways. As shown in FIG. 19A, the upper layer material 1026t may define a central region and may be formed of a flexible material such as ^{PDS ®, PGA, Neoveil ®,} ORC or other polymers and structural materials of biological origin, or combinations disclosed herein. The geometry and structure of the material (material thickness, fiber orientation, polymer chain orientation, hole pattern, etc.) can be used to create the necessary characteristics of isotropic or anisotropic deformation. The bottom layer of material 1026b may also be substantially flexible, and in some aspects may have greater flexibility than the top layer 1026t. The bottom layer 1026b may have a shape that fits the shape of the top layer 1026t and, as shown, has a substantially rectangular shape. The upper layer 1026b may have a larger surface area than the upper layer 1026t, so that the lower layer 1026b passes along the lateral edges of the upper layer 1026t. As shown, the lateral edges of the lower layer 1026b can be deepened, and they have many semi-circular projections 1028 along the pterygoid part 1024. These semi-circular projections can also be placed at equal distances from each other along the edges, or may be placed in groups of two, three , four, and groups of projections can be placed at equal distances from each other along the edge. If the auxiliary material 1020 is stapled to the fabric, the upper layer 1026t of material 1026t will be placed aside and will not directly contact the fabric, while the lower layer 1026b will directly contact the fabric. In addition, the protrusions can be placed away from the rows of brackets and can distribute the tension throughout the fabric T to prevent the formation of stains. The lower layer 1062b may be formed of a flexible material such as ^{PDS ®, PGA, Neoveil ®,} ORC or other polymers and structural materials of biological origin, or combinations thereof disclosed herein. The geometry and structure of the material (material thickness, fiber orientation, polymer chain orientation, hole pattern, etc.) can be used to create the necessary characteristics of isotropic or anisotropic deformation. In one embodiment, at least one of the top layer 1062t and the bottom layer 1062b at least partially consists of PDS ^® to facilitate attachment to adjacent layers. In one embodiment, both the top layer 1062t and the bottom layer 1062b are made of absorbable materials.

Auxiliary material can be made in various ways. For example, the auxiliary material may be formed from a continuous material. That is, as shown in FIG. 19B, the accessory material 1020 may include a single layer with a central region 1022 and a pterygoid portion 1024 having a plurality of protrusions 1024 for tension distribution. In other aspects, the auxiliary material may include more than two layers of material. For example, one or more intermediate material layers (not shown) may be located between the upper layer and the lower layer and may be more rigid than the upper and lower layers. Layers can be interconnected using well-known manufacturing techniques, such as layering, applying an adhesive, etc. The protrusions 1028 on the pterygoid 1024 of the auxiliary material can also be formed using known manufacturing techniques such as laser cutting, stamping, cutting, etc.

Another illustrative auxiliary material is shown in FIG. 20 and includes the pterygoid region having different geometries. As shown, the accessory material 1020 ′ may have a pterygoid region 1024 ′ extending around the perimeter of the central region 1022 ′, and may have a plurality of surface means 1028 ′ formed therein and placed evenly along the pterygoid region 1024 ′. Surface tools 1028 ′ can usually be made in the form of a boomerang and can include a bend 1023 ′ and the first and second arms 1025 ′, 1027 ′, extending from it. As shown in FIG. 20, the bend 1023 ′ may be located along the edges 1022a ′, 1022b ′, 1022c ′ of the central region 1022 ′, while the end edges 1025t ′, 1027t ′ of the shoulders 1025 ′, 1027 ′ may be located at the outer edge of the pterygoid region 1024 ′. Thus, the thickness of the pterygoid region 1024 ′ in the direction opposite to the longitudinal axis of the central region 1022 ′ can vary, and the thickness of the pterygoid region 1024 ′ in the direction parallel to the longitudinal axis of the central region 1022 ′ can also vary. These surface tools 1028 ′ can be made by removing a portion of the auxiliary material 1020 ′ using known manufacturing techniques such as laser cutting, stamping, cutting, etc.

FIG. 21A-21C, an auxiliary material is illustrated including pterygoid parts with modified edges. For example, the pterygoid portion 1034 of the auxiliary material 1030 shown in FIG. 21A, may have an outer edge in the form of a sinusoid with peaks of 1034p and valleys of 1034v along its length, so that the pterygoid part of 1034 is atraumatic and does not increase the likelihood of stains in the tissue. The pterygoid part 1034 ′ shown in FIG. 21B includes a first material 1036 ′ forming the central region 1032 ′ and the pterygoid portion 1034 ′, with the pterygoid portion 1034 ′ having rounded edges that are rounded and extending towards the central region 1032 ′ and back towards the edge forming the oblong hole 1035 ′ . In certain aspects, the second material 1038 ′ is located in the elongated teardrop-shaped holes 1035 ′, for example, when layered on the first material 1036 ′ to form the auxiliary material 1030 ′. The thickness of this second material 1038 ′ may vary depending on the thickness of the first material 1036 ′. For example, the thickness of the second material 1038 ′ may be less than the thickness of the first material 1036 ′, as shown. The pterygoid part 1034 ′ ′ shown in FIG. 21C may have a plurality of holes 1035 ′ ′ formed therein, such as triangular-shaped holes, which may form protrusions 1038 ′ ′, similar to the protrusions 1028 shown in FIG. 19B, but the protrusions 1038 ′ ′ may have angles rather than rounded edges. Auxiliary materials 1030, 1030 ′, 1030 ′ ′ shown in FIG. 21A-21C may be formed from various materials, such as any flexible or stretchable polymeric materials described herein. When applied, any of the auxiliary materials 1030, 1030 ′, 1030 ′ ′ may be stapled to the fabric and any of the corresponding pterygoid portions may extend along the line of the brackets. As shown in FIG. 21D, the auxiliary material 1030 may be stapled to the fabric T and the pterygoid portion 1034 may be located outside the brackets 1008, which form a line of brackets, and the central portion 1032 may be located within the line of brackets. In certain aspects, as the fabric is enlarged and compressed, the auxiliary materials may stretch or bend in the direction opposite to the rows of brackets, or may be made stretchable in several directions, for example, along the outer surface of the fabric T, as shown. The person skilled in the art will understand that the edges of the pterygoid parts can be molded in other ways than the illustrated embodiments.

FIG. 22A-22C illustrate another embodiment of an auxiliary material including a pterygoid portion with modified edges. As shown in FIG. 22A, accessory material 1040 may be woven. The center region 1042 of the auxiliary material 1040 may be formed from a woven material of greater density than the woven material of the pterygoid 1044 of the auxiliary material 1040. In other aspects, the woven material of lesser density may comprise a more dense woven material from all sides, as shown in FIG. 22b. In both embodiments, the implementation of the pterygoid portion 1044 may have soft atraumatic edges 1046, which with a reduced likelihood can cut or otherwise damage the fabric and form holes in it. The auxiliary material 1040 may be adapted to absorb and / or absorb the liquid itself. For example, in one embodiment shown in FIG. 22C, the upper layer 1048t ′ of the material of the auxiliary material 1040 ′ is shown located above the lower layer of material 1048b ′, with the liquid 1047 ′ being absorbed through the upper layer of material into the space between the upper and lower layers 1048b ′, 1048t ′. These materials aid material can be formed from a variety of woven materials known in the art, such as ETHISORB ^® (Ethicon, Inc., Somerville, NJ). In one embodiment, the central region 1042 may be a film consisting of a solid, but deformable, absorbable material.

Ancillary material for use with a stapling tool that pushes staples with variable thickness is shown in FIG. 23A-23D. As shown, the thickness of the auxiliary material 1050 may vary from the central axis 1056 to the outer edge of the auxiliary material 1050 in the lateral direction indicated by the arrows. That is, the auxiliary material 1050 may have a decreasing / tapering thickness from the central axis 1056 of the auxiliary material 1050 to its outer edge in the lateral direction. As shown in previous embodiments, support material 1050 may include a central region 1052 and a pterygoid portion 1054. Auxiliary material 1050 may include an elongated tray 1058 formed along the central axis 1056 of auxiliary material 1050 and having a size and shape that matches the size and shape of the cutting tool (not shown). In the illustrated embodiment, the elongated tray 1058 has a substantially rectangular shape. FIG. 23B and 23C are rear views of the cassette assembly 52 and the stop member 54 having a variable thickness in the lateral direction, so that the stapling tool 10 can push out the brackets (not shown) of a variable height. As shown, the thickness TO of the stop member 54 near the cutting tool tray may be greater than the thickness TE of the stop member 54 near its lateral edge. The auxiliary material 1050 may be connected to the cassette 52 assembly and / or to the stop element 54, at least the central region 1052 of the auxiliary material 1050 directly contacting the surface of the cassette 52 / stop element 54 contacting the fabric-contacting surface 54. Contacting the fabric the surface 58 of the abutment member 54 may include one or more connection points 1057 for attaching the auxiliary material 1050 to the abutment rod 54, as shown. The pterygoid portion 1054 of the auxiliary material 1050 may be folded around and attached to the assembly of the cassette 52 and / or the stop member 54, which will be described in more detail below. Thus, the fabric-contacting surface 1053 of the first auxiliary material 1050 may be substantially flat and may be arranged parallel to the fabric-contacting surface 1053 ′ of the second auxiliary material 1050 ′ located on the cartridge assembly 52. If the auxiliary materials 1050, 1050 ′ are stitched with brackets on the fabric as shown in FIG. 23D, the pterygoid portion of the auxiliary material 1050 may be positioned between the brackets 1008 and extend towards the final end TE of the cut T, while the second part of the auxiliary material 1050 may extend away from the final end TE of the cut T and distribute the tension of the cloth T like the winged parts described above. Auxiliary material 1050 ′ may have similarly arranged portions 1052 ′, 1054 ′, as shown.

Any of the auxiliary materials may include various means for increasing friction between the auxiliary material and the fabric to ensure that the auxiliary material remains in the desired position. For example, auxiliary materials 1060, 1060 ′ in FIG. 24A and 24B include a plurality of teeth 1061, 1061 ′ formed on its surface in contact with the fabric, and they can end at points 1063, 1063 ′ that can penetrate the fabric. As shown, a plurality of teeth 1061, 1061 ′ can be located at equal distances from each other in the lateral direction of the auxiliary material 1060, 1060 ′. The teeth 1061, 1061 ′ can be formed in the auxiliary material 1060, 1060 ′ using various known manufacturing techniques, for example, by direct pressing, cutting / stamping, cutting, etc. For example, support material 1060 shown in FIG. 24A may be obtained by direct compression, while the auxiliary material 1060 'shown in FIG. 24B, can be formed using slots 1065 ′ for stamping in material with teeth 1061 ′. The gaps between the teeth 1061, 1061 ′ can be pushed into the fabric T and form an engagement that prevents the auxiliary material 1060, 1060 ′ from slipping, as shown in FIG. 24C, in which several rows of auxiliary materials 1060 ′ are illustrated. In another embodiment, shown in FIG. 25A, the auxiliary material 1060 ′ ′ may include a plurality of microcolumns 1063 ″ ′ formed on its surface contacting the fabric, while the microtolbets 1063 ′ ′ have needles shaped to penetrate inside the fabric T. Teeth 1063 and / or microcolbics 1063 ′ ′ can directly penetrate T tissue, as shown in FIG. 24D and 25B, and can thus prevent the auxiliary material 1060, 1060 ′ ′ from slipping relative to the staples 1008 when the fabric T is enlarged and compressed. In certain aspects, the microtollers 1063 ′ ′ can have a diameter D1 in the range from approximately 0.01 to 0.50 mm and height H1 in the range of approximately 0.05 to 0.50 mm.

FIG. 26A-26C show another embodiment of the supporting material. In this embodiment, an auxiliary material, such as auxiliary material 1000 shown in FIG. 17A and 17B are used in combination with a protruding extension member 1070, which may be connected to the stop member 54 and / or the assembly of the cassette 52 of the surgical stapling instrument 10. As shown in FIG. 26A, the distal end 1004d of the auxiliary material 1000, i.e., the distal end 1004d of the pterygoid portion 1004, may end together or proximally to the most distal end 52d of the cassette assembly 52. As shown in FIG. 26B, the distal end 1004d of the auxiliary material 1000, that is, the distal end 1004d of the pterygoid portion 1004 may terminate together or proximally to the most distal end 54d of the abutment element 54. A protruding extension element 1070 may be added to the cassette assembly 52 and / or the abutment element 54 for replacement or complements the distal portion of the auxiliary material 1000. The proximal end 1070p of the protruding extension 1070 may have a notch 1072 formed therein and be sized so as not to disturb or close the lot k, formed in the thrust member 54 for the passage therethrough of the cutting tool (not shown). The cutout 1072 can define the first and second extension arms 1074a, 1074b that can be detachably connected to the distal end 54d of the abutment element 54 along the rounded portion of the abutment element 54 that is distal to the surface in contact with the fabric of the abutment element 54 in various ways, for example using glue. The most distal end 1070d of the protruding extension element 1070 may be substantially rounded. A mechanism for releasing the distal portion 1076 of the protruding extension 1070 from the proximal end 1070p of the protruding extension 1070 may also be presented. In certain aspects, this release mechanism may consist of a perforation 1078 extending in the opposite direction to the longitudinal axis LN of the protruding extension 1070. The auxiliary material 1000 may be located on the stop member 54 and the protruding extension member 1070 may also be connected to the stop member 54. The stop member 54 and the cassette assembly 52 can grip the fabric T therebetween, and a portion of the auxiliary material 1000 can extend distally along the protruding extension member 1070, as shown in FIG. 26b. That is, the distal end 1070d of the protruding extension element 1070 may be located distally relative to the distal end 1004d of the auxiliary material 1000. The abutment element 54 and the cartridge assembly 52 can push the staples 1008 through the fabric T and through the auxiliary material 1000, while the pterygoid area 1004 of the auxiliary material 1000 does not include brackets 1008 passing through it. The pterygoid region 1004 of the auxiliary material 1000 may be in direct contact with the fabric T and the protruding extension element 1070 may be located above the pterygoid region 1004. In certain aspects, the protruding extension element 1070 may be a semi-flexible material and may be used in combination with the auxiliary material 1000 to provide attenuation tension on the fabric T and / or ensure the strength of the auxiliary material 1000. When applied, the distal end of the protruding extension shaft cient 1070 can be removed from the rest member 54 and / or tape prior to, during and / or after a stapling tissue T.

Since the auxiliary material means described above has been illustrated as separate embodiments, the auxiliary material can have any combination of the means described above.

MECHANISMS OF ATTACHMENT AND RELEASE OF AUXILIARY MATERIALS FROM THE END EFFECTOR

Various mechanisms can be used for attaching and subsequently releasing an auxiliary material having pterygoid elements of an end effector, for example, a cassette assembly 52 or a stop element 54. Since the embodiments described below include means provided on the stop element 54, any of these tools can be performed on the cassette assembly 52 for connecting the auxiliary material to the cassette assembly 52. FIG. 27A-27B, an auxiliary material 1000 ′, 1000 ′ ′, having connection means, attached to the corresponding connection design features formed on the abutment member 54 is illustrated. More specifically, in FIG. 27A, an auxiliary material 1000 ′ is shown having a plurality of cylindrical protrusions 1003 ′ formed on the surface 1007 ′, which is oriented away from the surface in contact with the fabric 1005 ′ of the auxiliary material 1000 ′. Since FIG. 27A illustrates three cylindrical protrusions 1003 ′ spaced apart from each other along an axis parallel to the longitudinal axis LA of the abutment member 54, then any number of protrusions 1003 ′ can be formed in various arrangements along the auxiliary material 1000 ′. The lateral surface 54L of the abutment element 54 may have a plurality of recesses 53 configured to receive a plurality of protrusions 1003 'from the auxiliary material 1000'. In one embodiment, the height (not shown) of the cylindrical protrusions 1003 ′ may vary, and may be in the range of approximately 0.25 to 1.00 mm, wherein the height is measured perpendicular to the surface 1007 ′ of the auxiliary material 1000 ′. The protrusions 1003 ′ formed on the auxiliary material 1000 ′ may have other sizes and shapes. As shown in FIG. 27B, in another embodiment, the auxiliary material 1000 ″ may have one elongated rectangular protrusion 1003 ′ ′ extending parallel to the longitudinal axis LA of the abutment element 54. The lateral surface of the abutment element 54 may also include a corresponding elongated rectangular recess 53 ′ for receiving a rectangular protrusion 1003 ′ ′, if the auxiliary material 1000 ′ ′ is folded around the stop element 54. The height (not shown) of the rectangular protrusion 1003 ′ ′ may also vary, but may also be essentially in e range as the height of the cylindrical protrusions 1003 ', described above. While only the first lateral surface 54L of the abutment member 54 is shown in FIG. 27A and 27B, it will be understood by those skilled in the art that identical protrusions may be formed on the second lateral surface (not shown) of the abutment member 54. Similarly, identical recesses may be formed on the second lateral surface (not shown) of the auxiliary materials 1000 ′, 1000 ′ ′.

The auxiliary material may be connected to the stop element / assembly of the cassette in various ways. As shown in FIG. 28A and 28B, the suture thread 1003 ′ ′ ′ can connect the auxiliary material to the abutment member 54. The suture thread 1003 ′ ′ ′ can extend from the first lateral surface 54L of the abutment element 54, through the tissue-contact surface of the auxiliary material, and to the second lateral surface 55L stop element 54. The first and second notches 53 ′ ′ ′, 55 ′ ′ ′ can be formed in the first and second lateral surfaces of the stop element 54, and the first final end of the suture thread 1003 ′ ′ ′ can be obtained by the first notch 53 ′ ′ ′ and I finish the second s end can be obtained by the second recess 55 '' '. The length of the suture thread 1003 ′ ′ ′ and / or the size of the grooves 53 ′ ′ ′, 55 ′ ′ ′ can be chosen so that the suture thread 1003 ′ ′ ′ is tensioned if the final ends of the suture thread 1003 ′ ′ ′ are located inside the grooves 53 ′ ′ ′, 55 ′ ′ ′. When extending the cutting tool 59 through the stop element 54 during and / or after pushing the staples 1008 into the fabric T, as shown in FIG. 28B, the cutting tool 59 may cut the suture thread 1003 ′ ′ ′, which causes the final ends of the suture thread 1003 ′ ′ ′ to slip out of the notches 53 ′ ′ ′, 55 ′ ′ ′ and thus release the auxiliary material from the abutment member. FIG. 29A and 29B illustrate a suture thread 1003 ′ ′ ′ extending around the abutment member 54 and connecting the laminate auxiliary material 1020 to the abutment member 54. As in the previous embodiment, the extension of the cutting tool (not shown) relative to the abutment member 54 can cut the suture thread 1003 ′ ′ ′ And release the suture thread 1003 ′ ′ ′ from the notches 53 ′ ′ ′, 55 ′ ′ ′ in the stop member 54 to release the auxiliary material 1020. As will be clear to a person skilled in the art, any number of suture threads can also be used l for binding the auxiliary material to one of the assembly of the cassette 52 and the abutment element 54, and the notches formed therein, can vary, since they are adapted to receive part of the suture thread.

FIG. 30A-30B illustrate other mechanisms for attaching auxiliary material to a stop element / cassette assembly. In this embodiment, the stop member 54 of the surgical stapling instrument 10 includes a cutting tool 59, which can be extended inside the tray 61, called the longitudinal track, and can move between the proximal and distal ends 61p, 61d of the track 61. The ejector 1081 comprising the first and second elongated elements (not shown) may be located in the longitudinal track 61, as in FIG. 30b. Three cylindrical protrusions (not shown) extend from the elongated elements into recesses 53 ′ ′ ′ ′, 55 ′ ′ ′ ′ formed in both lateral surfaces of the abutment member 54, but any number of protrusions may exist along the ejector and having various other shapes . As shown in FIG. 30C, the first ejector 1081a typically can be extended and can have a plurality of protrusions 1083, for example, three protrusions 1083 oriented in the opposite direction relative to the longitudinal axis of the ejector, with the protrusions 1083 having a cylindrical shape. The pterygoid portion 1084 of the auxiliary material 1080 may be placed around the lateral surface of the abutment element 54 and may include a plurality of protrusions 1083 ′ oriented in the opposite direction relative to the longitudinal axis LA of the abutment element 54 if the auxiliary material 1080 is associated with it. As shown in FIG. 30D, support material 1080 may have a first set of protrusions 1083 ′ for connecting the first lateral surface of the abutment element 54, and a second set of protrusions 1083 ′ ′ for connecting the second lateral surface of the abutment element 54. Before use, the first ejector 1081a may be located on the first lateral wall track 61, and the second ejector 1081b may be located on the second lateral wall of the track 61. The proximal end of each ejector 1081a, 1081b may have an inclined part 1085p, 1087p in such a way that if ejectors 1081a, 1081b are placed in track 61, then the width W1 between the ejectors 1081a, 1081b at the proximal end of track 61 exceeds the width W2 between the ejectors 1081a, 1081b and / or distal to the protrusions 1083 ′, while the width is measured perpendicular to the longitudinal axis LA of the stop element 54, as shown in FIG. 30E. In addition, the width W2 between the ejector 1081a, 1081b distal to the proximal end 61p of the track 61 may be less than the width WC of the cutting tool 59. Thus, the cutting tool 59 may extend towards the distal end 54d of the abutment element 54 may increase the width between the ejector 1081a, 1081b and the protrusions 1083 may push the corresponding protrusions 1083 ′ on the auxiliary material 1080 from and away from the stop element, as shown in FIG. 30F, thus releasing the auxiliary material from the abutment element 54. In certain aspects, the auxiliary material 1080 can be deflected to flatten a substantially flat configuration so that if the cutting tool 59 extends into the track 61 and reports the force to the ejector 1081a, 1081b, then the auxiliary 1080 material is more likely to be released from the stop member 54.

The loading mechanism for loading the auxiliary material into the stop element / cassette assembly is shown in FIG. 31A-3B. The loading mechanism 1090 may have various sizes, shapes and configurations and may include a first curved shoulder 1092a and a second curved shoulder 1092b having a bend radius that corresponds to the bend radius of the first and second lateral surfaces 54L, 55L of the stop element 54 and shoulders 1092a, 1092b. oblique design features 1093a, 1093b that can be captured by the user. The loading mechanism 1090 may have a flat base 1094, from which each of the first and second curved arms 1092a, 1092b extend. Base 1094 of loading mechanism 1090 may additionally include an extension of track 1094e, extending perpendicular to base 1094 and positioned along the central longitudinal axis of loading mechanism 1090 for insertion of the cutting tool into tray 54s in stop member 54, as shown in FIG. 31B. The first inner surface 1094a of the loading mechanism 1090 may be determined by the first curved shoulder 1092a and the first part of the base 1094 from the first shoulder 1092a to the extension of the track, as shown in FIG. 31A. Similarly, the second inner surface 1094b of the loading mechanism 1090 may be determined by the second curved shoulder 1092b and the second base portion 1094 of the second shoulder 1092b to expand the track 1094e. Thus, the loading mechanism 1090 can typically be in the form of a three-legged element for receiving the stop member 54. Auxiliary material 1000 having a central region 1002 and a pterygoid region 1004 can be placed and configured in a layered structure between the internal surfaces of the loading mechanism 1090 element 54, as shown in FIG. 31B, wherein the loading mechanism 1090 is clamped onto the abutment member 54, as shown. The extension of the track 1094e can facilitate a tight connection between the loading mechanism 1090, the auxiliary material 1000 and the abutment element 54 with substantially no gaps between them. After the auxiliary material 1000 is connected to the stop member 54, for example using any attachment mechanisms described in this document, such as the attachment mechanisms 1052, the loading mechanism 1090 can be removed from the stop member 54. This is easy to accomplish, for example, by extruding the inclined means 1093a , 1093b of the curved arms 1092a, 1092b from each other, leaving the stop element 54 loaded with auxiliary material 1000, as shown in FIG. 31C.

Another illustrative loading mechanism is shown in FIG. 32A-32C. The loading mechanism 1090 ′ can be packaged as a set along with an end effector of the stapling instrument. Alternatively, the loading mechanism 1090ʹ may be packaged separately. As shown in FIG. 32A, the stop element 54 and the modular cassette 52 of the end effector 50 may include auxiliary material 1000 preloaded in them, or in another not illustrated embodiment, the auxiliary material 1000 may be attached to the abutment element 54 and the cartridge unit 52 after removing from the package 1100 This loading mechanism 1090 ′ can be configured to wrap the pterygoid portion 1004 of the auxiliary material 1000 around the lateral surfaces 54L, 53L of the stop element / cartridge assembly 54, 52 in such a way that the snout part is passively connected to the stop element / node of the cassette 54, 52. As shown in FIG. 32B, the loading mechanism 1090 ′ can be adapted to bring the center material (not shown) of the auxiliary material 1000 into contact with the fabric-contacting surface of the support element / cassette unit 54, 52 and, if necessary, can be made to form a pterygoid part (not shown) around the stop element 54. The loading mechanism 1090 ′ can be formed from a single molding material having an upper holding portion 1104 and a lower holding portion 1102, while having holding pieces A channel (not shown) with a size and shape for adopting the stop member / node of the cassette 54, 52. The shape of the channel may be essentially the same as the previously described loading mechanism 1090 and may include any of these means, such as extending the track. The upper and lower holding portions 1104, 1102 may be located at an angle θL relative to each other, with the angle being in the range of approximately 10 to 40 degrees. The support member 1106 may extend between the lower surface of the upper holding part 1104 and the upper surface of the lower holding part 1102, so that the angle θL between the holding parts 1102, 1104 is fixed. Support element 1106 may essentially be a solid element, as shown, in order to ensure the rigidity of the loading mechanism 1090 '. The first end of the support element 1106 may end with a gripping design feature 1108, and the gripping design feature 1108 may have first and second flat surfaces 1108a, 1108b adapted to be gripped by a user, for example, between a user's thumb and index finger. The gripping design feature 1108 may additionally include one or more surface means 1110 to increase friction between the user's fingers. The longitudinal axis of the gripping design feature 1108 may be oriented perpendicular to the longitudinal axis of the stapling instrument 10 or may be parallel to the longitudinal axis of the stapling instrument 10. When applied, the user can grab the gripping design feature 1108 and place distal ends 1102d, 1104d of retaining parts adjacent to proximal ends 52p , 54p of the cassette assembly 52 and the stop element 54. The user can extend the distal end of the loading mechanism 1090 ′ in the direction of the proximal The bottom end effector 50, as shown in FIG. 32B, and the holding portions 1102, 1104 may slide along the abutment element / assembly of the cassette 54, 52 and guide the auxiliary material 1000 around its lateral surfaces, as shown in FIG. 32C. This can temporarily secure the pterygoid region 1004 along the lateral surfaces of the cassette 52 assembly and the thrust element 54. With this arrangement of the pterygoid region 1004, the user can retract the loading mechanism 1090 'in the opposite direction, distal from the end effector 50, leaving the end effector 50 ready for insertion into the body the patient. Since reference is made to one auxiliary material 1000 loaded into the stop member 54, the auxiliary material 1000 ′ can be similarly loaded into the cassette assembly 52. Auxiliary material 1000, for example, the material shown in FIG. 32A-32C may be a shape memory material, so that the auxiliary material 1000 is displaced substantially to the rectified configuration. That is, if the end effector 50 is located inside the patient's body, then the pterygoid regions can automatically move back to a substantially straightened configuration before being pushed out of the end effector 50 into the tissue.

DELIVERY OF AUXILIARY MATERIALS TO THE PATIENT'S BODY

End effectors with one or more supporting materials associated with them can be delivered to different areas of the patient's body, for example, into the chest cavity, stomach, etc. As will be appreciated by a person skilled in the art, ancillary material may be delivered through an access port, for example, a trocar passing into the patient’s body. Any of the auxiliary materials in this document may include means that can facilitate the delivery of the auxiliary material inside the patient's body. For example, in FIG. 33A, the auxiliary material 1000 is illustrated having a solid central region 1002 and a cellular pterygoid region 1004 associated with the anvil 54 of the surgical stapling instrument 10. As the ancillary material 1000 is shown associated with the anvil 54, the other ancillary material 1000 ′ may be associated with the cassette 52 assembly before the introduction of the end effector 50 into the patient's body. The distal portion of the auxiliary material 1000, for example, the distal portion 1004d of the pterygoid region 1004, may be configured to direct the proximal portions 1004p of the pterygoid region 1004 around the lateral surfaces (not shown) of the abutment element 54 to minimize the width of the auxiliary material, as shown in FIG. . 33B. This can facilitate the introduction of the end effector 50 and the auxiliary material 1000 into the access port, such as port 1202 formed in the trocar 1200, since the width of the stop element / node of the cassette 54, 52 including the auxiliary material 1000 will be approximately the same as the width of the stop element / cassette unit 54, 52 without auxiliary material. In certain aspects, this distal portion 1004d of the pterygoid region 1004 may be formed from a more rigid material than the remaining portions of the pterygoid region 1004 to facilitate the direction of the auxiliary material 1000 to port 1202.

SEWING AUXILIARY MATERIALS TO FABRIC

The auxiliary material may include means facilitating multiple activation of the staples along the fabric. FIG. 34A illustrates an embodiment of an end effector 50 1300 having first and second auxiliary materials 1400, 1400 ′, the first auxiliary material 1400 being associated with the stop member 54 and the second auxiliary material 1400 ′ associated with the cassette assembly 52. As shown, each of the auxiliary materials 1400, 1400 ′ may include several layers, and may have a different width in the direction opposite to the longitudinal axis (not shown) of the stop element / node of the cassette 54, 52. The first fabric-contacting layer 1402, 1402 ′ of each auxiliary 1400, 1400 ′ may be located adjacent to a fabric (not shown) if the fabric is caught between the abutment member 54 and the cassette 52 assembly. In certain aspects, the first fabric-contacting layer 1402, 1402 ′ may be formed from seals around the line of brackets, such as elastomeric material. The first fabric-contacting layer 1402, 1402 ′ may have a width W5 in the direction opposite to the longitudinal axis LA of the abutment member 54, which is substantially equal to the width WA of the abutment member 54, or the width W5 of the first layer 1402 may be less than the width WA of the abutment member 54. Like shown in FIG. 34A, the first fabric-contacting layer 1402 may include a first portion 1402a located on the first side of the cutting tool tray 54s, and a second part 1402b located on the second side of the cutting tool tray 54s, rather than being formed from a continuous piece of material. In other aspects, the first layer 1402 may be one continuous piece of material. The second layer 1406, 1406 'may be located closer to the surface in contact with the fabric of the abutment element 54 and may 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 abutment member 54. This second layer 1406, 1406 ′ may help to prevent the fabric T from stretching around the staples 1008. The third layer 1408, 1408 ′ may be located closest to the contact with fabric surface of the thrust element 54, so that the second layer 1406, 1406 ′ is configured in a layered structure between the first and third layers 1402, 1402 ′ and 1408, 1408 ′. The third layer 1408, 1408 ′ may have a width W7 that exceeds the width WA of the abutment element 54, but which is less than the width W6 of the second layer 1406, as shown. This third layer 1408, 1408 ′ may be semi-rigid in order to facilitate tension relief in the fabric T with increasing and compressing the fabric T. The longitudinal length of the layers may also vary, while the length is measured in the direction opposite to the width. Preferably, the third layer 1408, 1408 ′ has the greatest length, measured along the longitudinal axis of the thrust element 54, compared with the longitudinal length of each of the first and second layers 1402, 1402 ′, 1406, 1406 ′. As shown in FIG. 34B, several auxiliary materials 1400, 1400 ′, 1400 ′ ′ can then be pushed into the fabric in a row and the longitudinal lengths of the layers can provide areas 1410a, 1410b if the first layer 1402 of one auxiliary material 1400 overlaps with the first layer 1402 ′ of another auxiliary material 1400 ′ . Thus, brackets 1008 can still penetrate these overlapping areas than if there were several, for example, three or more layers 1402, 1406, 1408 in it. In FIG. 33C illustrates two auxiliary materials 1400, 1400 ′ sewn with brackets to the fabric T at an angle of approximately 90 degrees relative to it, with the first auxiliary material 1400 having a first end and a second auxiliary material 1400 ′ having a second end. The first and second terminating ends of the overlapping region 1410a, as shown. These auxiliary materials 1400, 1400 ′ can be used to provide the user with pushing the auxiliary materials to arrange various geometric shapes in the fabric. These multilayer auxiliary materials 1400, 1400 ′ may be modified in various ways. Since the layers 1402, 1406, 1408 may have different thicknesses, in the illustrated embodiment, the second layer 1406 is thinner than the thickness of each of the first and third layers 1402, 1408. For example, the first layer 1402 may be in the range of about 3 to 15 mm the second layer 1406 may be in the range of approximately 5 to 20 mm and the third layer 1408 may be in the range of approximately 3 to 20 mm. In certain aspects, these layers 1402, 1404, 1406 and 1402 ′, 1404 ′, 1406 ′ can be layered together before connecting to the stop element / node of the cassette 54, 52. In some aspects, layers 1406 and 1406 may at least partially consist of absorbable material such as PDS ^® .

TISSUE FIXING WITH THE HELP OF TISSUE GLUE AND AUXILIARY MATERIALS

Any of the auxiliary materials in this document can be used in combination with a tissue adhesive to help maintain a seal around the brackets when the tissue is enlarged and compressed after surgery. Tissue glue may have different compositions and different viscosity and curing properties. Typically, a tissue adhesive can be made from a biocompatible and bioparable material that can be made to change from a first, liquid to a second, solidified state through a curing process, such as a polymerization reaction. The first state may be a softened state, for example, a liquid, gel, foam, etc., and the second state may be a solidified state, for example, a solid, a rigid element, etc. If the fabric glue is in the first, softened state, then the fabric glue can flow through the delivery tube into the sealing cuff, as described in more detail below. Tissue glue can pass from the first, softened state to the second, cured state after a predetermined period of time. In certain aspects, a tissue adhesive may be formed from a biological material. In some embodiments, a tissue adhesive may facilitate wound healing by releasing various chemical compounds during and / or after curing the tissue glue in the human body. As a non-limiting example, a tissue adhesive can be made to release a therapeutic drug, such as wound healing stimulants (eg, transforming growth factor-beta, etc.), antibacterial agents (eg, triclosan, ionized silver, etc. .) and other known means over time to facilitate healing of the tissue around the location of the tissue adhesive in the body. In one embodiment, the fibrin tissue adhesive may include two reactive components combined just prior to delivery to the patient's body, for example, thrombin and a biologically active component (BAC2), fibrinogen and factor XIII. In certain aspects, components may be provided in a 5: 1 volume ratio of BAC2 to thrombin. In an alternative embodiment, the material may be a fibrin tissue adhesive sold under the trade name Evicel ^® . In another embodiment, the tissue adhesive may be blood, for example, autogenous blood.

FIG. 35A illustrates the auxiliary material shown in FIG. 17B, which has a 1500 fabric adhesive applied to it. As shown, the fabric glue 1500 can be delivered in such a way that it essentially covers the central 1002 and pterygoid areas 1004 of the auxiliary material 1000, or in another embodiment (not shown) the fabric glue 1500 can be selectively delivered only to the central area 1002 and not to the pterygoid area 1004.

The fabric adhesive 1500 can be delivered to the auxiliary material in other ways, and it should not be delivered to the outer surface of the auxiliary material 1000. For example, in FIG. 35B illustrates the multilayer auxiliary materials 1700, 1700 ′ sewn with brackets to the fabric T. The layers 1702, 1704 may be formed from various materials, but in the illustrated embodiment, they include a first layer 1702 of a fiber frame located adjacent to the fabric T and the second layer 1704, consisting of an elastic film. A delivery tool 1706, having an injection needle 1708, may have a fabric glue 1500 disposed therein, and it may penetrate into the first layer 1702 of the fiber frame. The fabric adhesive 1500 can be delivered to this first layer 1702, as shown in FIG. 35C, and the injection needle 1708 may be removed from the patient’s body. The fabric glue 1500 can contact directly with the fabric T and / or can be held in firm contact with the fabric using layer 1704 and, as shown in other embodiments, can have a pterygoid region 1704, 1704 ′, which distributes the tension of the fabric along brackets 1008 in line brackets. If the fabric adhesive is Evicel ^® , then the material forms a fibrin clot of fibrinogen. Without loss of generality, other types of tissue glue form a cured curing structure through various mechanisms that are suitable for sealing the stains. The combination of fabric glue 1500 and auxiliary material 1700 can prevent the formation of smudges while increasing with the compression of fabric T. Auxiliary materials 1700 ′ and layers 1702 ′, 1704 ′ can be essentially similar to the layers of auxiliary material previously described.

Tissue glue can be used to secure the fabric in other ways. For example, in FIG. 36A-36C illustrates a tissue adhesive 1500 that is delivered to the chest cavity of 1800 patients. As shown in FIG. 35A, a tissue glue delivery system 1900 1500 may include a container or balloon 1902 for making tissue glue components A, B, C 1500. In certain aspects, components A, B, C may include acid-solubilized collagen A, fibrinogen B, and thrombin C. Trocar 1200 may pass through an incision 1904, formed in the patient's body 1906, into the chest cavity 1800. The applicator tool 1908 may have a barrel 1910 passing through the trocar 1200, with the distal end 1910d of the barrel 1910 ending with the chest cavity. The handle assembly may be formed at the proximal end of the 1910p of the barrel 1900 and may be adapted to be gripped by the user. The handle assembly 1912 may be a pistol type handle assembly and may include one or more actuators, for example, the inclusion lever 1914, which may be rotated to actuate the device 1908. The cylinder 1902 and the applicator tool 1908 may be connected together in various ways, for example using a tube 1916. This tube 1916 may be substantially flexible to facilitate movement of the applicator tool 1908 during the procedure. The cylinder 1902 may have a second tube 1918 connected to it and connected to the source S of gas, so that gas 1920 may be delivered to cylinder 1902. Gas 1920 may include, as a non-limiting example, CO ₂ , O ₂ , etc. In some aspects, the source S of gas may be a continuous source of gas, for example, a continuous source of CO ₂ gas, available in operating rooms of hospitals. One or more valves (not shown) may be located in the tube 1916, in the handle assembly 1912, in the barrel 1910, or in any other part of the system 1900 and may selectively open and close when the actuator is activated, for example, when turning the actuator 1914 on the handle assembly 1912 For example, one valve can control the flow of gas 1920 into the cylinder 1902, and the other valve can control the delivery of tissue glue 1500 to the applicator tool 1908. After stitching tissue T with brackets, for example by pushing one or more brackets of cartridges into the fabric th, the distal end 1910 of the applicator barrel 1910d tool 1908 may be located near the brackets 1008 as shown in FIG. 36B. Preferably, the distal end 1910d of the applicator tool 1908 is spaced from about 5 to 30 mm away from the line of brackets, depending on the size of the area to be covered. The user can grab the handle assembly 1912 of the applicator tool 1008 and activate the actuator 1914, for example, by moving the rotary lever 1914 to turn on in the proximal direction. This can open the valve located in the system 1900, and gas starts to be delivered 1920 to the balloon 1902 to spray tissue glue 1500, so that it forms encapsulated liquid droplets that can be sprayed directly onto the fabric T, as shown. Thus, fabric glue 1500 can be delivered to the fabric along the line of brackets, as shown in FIG. 36C. The fabric glue 1500 can be cured on it to form hardened areas 1500h, providing and maintaining a seal along the staples 1008. The fabric glue 1500 can also be delivered to the auxiliary material and not directly to the fabric T, for example, to any auxiliary materials described in this document. As will be understood by a person skilled in the art, tissue glue can be delivered to any part of the fabric, for example, only to the fabric at the location of the line of brackets and / or along the line of brackets.

Tissue glue can be delivered in various ways. For example, the system 1900 ′ for delivering tissue adhesive 1500 is shown in FIG. 37A and includes many of the features shown in FIG. 36A, including gas source, balloon, etc. However, in this embodiment, the system delivers the tissue glue 1500 to be spread directly through the trocar 1200 and does not include the applicator tool. In this embodiment, the inclusion of valves in the system is also not required and the delivery of 1920 gas to cylinder 1902 can be controlled simply by using the valve at the gas source. Upon delivery of gas to balloon 1902, fabric glue 1500 can also be sprayed, but rather encapsulated liquid droplets are formed, while gas 1920 can be delivered at a higher pressure and speed to form a sprayed cloud of fabric glue 1600. As shown in FIG. 37B, this cloud of tissue glue 1500 can be distributed across the entire chest cavity of a patient and can be cured on all surfaces of the fabric, for example, to form hardened areas 1500h along all the surfaces of the patient’s lungs.

In one embodiment, in which the tissue adhesive is blood, for example, autogenous blood, blood may be collected from a patient and applied to auxiliary material. As a non-limiting example, the auxiliary material may be an ORC, a known hemostatic agent, and applying blood to the ORC auxiliary material will cause a clot to form, which provides an efficient sealing structure. The person skilled in the art will recognize that blood, for example, autogenous blood, can be applied to various auxiliary materials to provide an improved sealing structure. In addition, the person skilled in the art will recognize that the volume of blood applied to the auxiliary material will vary depending on several factors, including the type and location of the tissue, the age and condition of the patient, and the identity of the auxiliary material. Generally, however, if the auxiliary material is an ORC material, blood can be applied in an amount in the range of from about 5 to 10 cc per line of staples used to secure the auxiliary material on the fabric.

REPROCESSING

The devices described herein may be adapted for disposal after a single use, or they may be configured to be used a plurality of times. However, in any case, the device can be restored for re-use after at least one application. Recovery may include any combination of device disassembly steps, subsequent cleaning or replacement of specific parts and subsequent reassembly. In particular, the device can be disassembled and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing specific parts, the device can be reassembled for later use either in the restoration workshop or by the surgical team immediately before the surgery. It will be apparent to those skilled in the art that various techniques for disassembling, cleaning, replacing, and reassembling can be used to restore the device. The use of such techniques, as well as the resulting reconstructed device, are entirely within the scope of this application.

In some embodiments, the implementation described in this document, the device can be processed before surgery. First, after receiving a new or already used tool, which may include auxiliary material, it is cleaned if necessary. The instrument can then be sterilized. In some embodiments, the implementation of the tool can be dried, for example, in a furnace, together with a means of drainage, which is better associated with moisture than auxiliary material. According to one method of sterilization, the instrument is placed in a sealed and sealed container, for example a plastic bag or a TYVEK bag (TYVEK), or a foil bag. The container and the instrument are then placed in a field of radiation that can enter the container, such as gamma radiation, x-rays, or fast electrons. Radiation kills bacteria on the instrument and in the container. In another method of sterilization, the instrument is placed in a first container, for example, in a plastic bag or a TYVEK bag having a vapor-permeable support. The first container can then be packaged in a second container, for example, a foil bag that can be left open. The first and second containers, together with the instrument, can be sterilized with ethylene oxide. The second container can be sealed to prevent exposure to moisture. Before sealing, the dehumidification means may be included in at least one of the first and second containers to further prevent changes to one or more components of the device. In both methods, sterilized materials can then be stored in a sterile container (s) to keep materials sterile until the container (s) are opened in a medical facility.

The person skilled in the art will appreciate the features and advantages of the present invention based on the embodiments described above. Accordingly, the present invention is not limited to those presented on the graphic materials and the described embodiments, except for the cases that are stipulated in the appended claims. All publications and materials cited in this document are fully and explicitly incorporated into it by reference.

Claims (9)

1. The end effector for a surgical instrument that contains: the first and second branches, the first branch having a cassette case attached to it with the possibility of removal, the cassette case has many cavities for brackets made with the possibility of the arrangement of brackets in them, and the branch has a stop element with a plurality of brackets forming holes formed therein, wherein at least one of the first and second branches is movable relative to the other branch; and a support having a width greater than the width of at least one cassette body and an abutment member, wherein the support includes (i) a compressible central region configured to seal around the bracket, and (ii) a strain relief region adjacent to the compressible region, wherein the strain relief region has a plurality of holes formed therein, and the tension relief region extends from at least two sides of the central region, where the support is detachably supported on at least one cassette case and the stop element and ene detachable from them when ejecting staples from the cartridge housing in the compressible region of support; moreover, the plurality of apertures are spaced apart from each other, so that the tension release region is more flexible along its lateral part, a part of the tension relief region adjacent to the compressible region. 2. The device according to p. 1, characterized in that the set of holes includes slots. 3. The device according to claim 2, characterized in that if the support and the brackets are pushed into the fabric, then a plurality of slots run parallel to the longitudinal axes of the brackets. 4. A method for implanting a tissue-reinforcing material into a tissue containing; fixing the tissue between the cassette assembly and the stop member of the surgical stapling instrument in the surgical field, wherein at least one of the cassette assembly and the abutment member has a tissue fastening material detachably attached thereto, the tissue fastening material includes a compressible central region made with the possibility of compaction around the bracket, and a flexible supporting area, adjacent to the central area, defining the edge of the material for fastening the fabric; and controlling the surgical stapler to push the staples out of the cassette assembly to form a line of staples through the central region into the fabric to hold the material to secure the tissue in the surgical field; moreover, this method further includes placing the cassette assembly and the stop member in the operating field, wherein the flexible support region is folded around at least one of the cartridge assembly and the stop member. 5. The method according to p. 4, characterized in that when managing a surgical stapling instrument, the staples are pushed through the central region, but the staples are not pushed out through the flexible supporting region of the material to secure the fabric. 6. The method according to p. 4, characterized in that when managing a surgical stapling instrument, the cutting tool extends through the material to secure the fabric and releases the material to secure the fabric from the surgical stapling tool. 7. The method according to p. 6, characterized in that when managing surgical stapling instruments cutting tool extends through the central region of the material to secure the fabric.

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