WO2017191500A1

WO2017191500A1 - Reinforcement and protection element, in a bioreabsorbale material, for anastomosis

Info

Publication number: WO2017191500A1
Application number: PCT/IB2017/000476
Authority: WO
Inventors: Luca ANSALONI; Fausto CATENA; Federico COCCOLINI; Roberto MANFREDI
Original assignee: Brisk S.R.L.
Priority date: 2016-05-05
Filing date: 2017-04-24
Publication date: 2017-11-09
Also published as: ITUA20163181A1

Abstract

The present invention relates to a reinforcement and protection element, in a bioreabsorbable material, for anastomoses, which comprises at least one substantially cylindrical body having an open end and having, at the opposite end, an axially perforated base, said reinforcement and protection element being suitable for being positioned on a mechanical stapler for anastomoses.

Description

REINFORCEMENT AND PROTECTION ELEMENT, IN A

BIOREABSORBABLE MATERIAL, FOR ANASTOMOSIS

The present invention relates to a reinforcement and protection element, made of bioreabsorbable material, for anastomosis.

The present invention derives from the field of devices or instruments used in surgery, in particular supporting devices and for optimizing the use of mechanical staplers in anastomoses.

In surgery, the term anastomosis refers to the particular suture that joins (grips) two hollow viscera so as to make them communicating, allowing the passage of the contents of the hollow viscus object of this procedure. Anastomoses are frequently performed in gastro-intestinal surgery, but they can be used in any hollow organ: coledoco, ureter, bronchi, blood vessels. Anastomoses can be constituted in different ways depending on the organ concerned, the functional result required, the manual or instrumental technique used, the surgeon's preferences. Anastomoses can be divided into different types:

latero-lateral anastomosis (ALL) : this type provides that two hollow viscus stumps are closed at the terminal end and then sutured side by side. After opening a gap in the wall of the two segments, an anastomotic suture is performed. The two stumps are normally oriented in the same peristaltic direction (the ALL is called isoperistaltic, but in particular cases, they can be positioned in opposition (and the ALL is called anisoperistaltic or antiperistaltic) . This technique is widely used in gastro-intestinal surgery as it is considered simple, rapid and safe;

termino-lateral anastomosis (ATL) : a technique with which the proximal stump of the hollow viscus to be sutured, in its terminal portion, left open, is sutured to the side wall (suitably open) of the distal stump (the terminal portion of the distal stump is closed in this case) ;

latero-terminal anastomosis (ALT): a technique with which the distal stump of the hollow viscus to be sutured, in its terminal portion, left open, is sutured to the side wall (suitably open) of the proximal stump (the terminal portion of the proximal stump is closed in this case ) ;

- termino-terminal anastomosis (ATT) : technique in which the terminal portions of the two stumps a and b (proximal and distal, both left open) are faced and directly sutured to each other. It is a technique mainly used in vascular, esophageal, surgery and in the intestinal terminal portion (rectum) . It requires particular attention in order to prevent the sutured section from being exposed to stenizing cicatrization.

Each of these sutures, shown in figure 1, has its own particular characteristics (with advantages and disadvantages) and can be particularly suitable in certain contexts and contraindicated (or impossible to perform) in others. These sutures were once carried out by hand. Today mechanical staplers (MS) are almost exclusively used.

Staplers are devices that are able to perform sutures and surgical anastomoses in an automated manner, with the aim of ensuring the optimal synthesis of the tissues, at least partly overcoming the limitation of the differences in the technical capacity and experience of the various surgeons.

These instruments were created and have been increasingly developed and refined with the aim, on the one hand, of making some sutures technically difficult, if not impossible for the anatomical position, such as sutures on the esophagus or on the lower rectum, more convenient and feasible, and on the other to increase the safety of anastomoses, endangered by the sepsis of the surgical site or by the septic content of some hollow organs such as the intestine.

Furthermore, the mechanical staplers currently adopted, which are the result of continuous studies and improvements of instruments dating back to the first versions at the end of 1800, also guarantee the use of standard protocols and procedures associated with these mechanical devices that operate with automatic suture mechanisms. In particular, this need for standardization is (and always has been) particularly felt in the performance of anastomoses and today mechanical sutures have definitely taken the place of those performed manually. If, in fact, on the one hand, they imply relatively high costs, on the other, they offer advantages that make their use irreplaceable:

they ensure calibrated and equidistant stitches; they allow a perfect hemostasis, obtained with the offset of two rows of "agraphes" (staples), which simultaneously also avoids the ischemic effect of the staple ;

they ensure the perfect sealing of the suture so as to avoid any spreading of the intestinal contents and therefore site infection;

they significantly shorten the intervention times; they minimize the damage caused to the parenchymas due to the minor trauma exerted on them and to the maximum biological tolerance to metal stitches, thus inert; they allow sutures to be obtained in positions and organs hard to reach manually.

In order to best describe the object of the present invention, a brief description is provided of the EEA (End-to-End Anastomosis) stapler and its functioning method .

The EEA stapler is among the most widely-used staplers for effecting intestinal anastomoses. More specifically it is composed of:

a long straight (or curved) hollow cylindrical rod, which comprises a handle at one end, provided with a lever (indicated with the reference L in figure 2) (with a safety catch) which triggers the section and suture mechanism contained in the charger C positioned at the other end of the rod. The charger C contains a sharp blade (1) and agraphes (staples) (A) positioned in two circular rows, a head T, connected to the charger C by a pin, which, on its surface facing the charger, contains recesses in which the staples (in the form of a C) are clinched and closed (in the form of a B) . The stapler also comprises a knob M, positioned at the end of the handle, which allows the head T to be progressively moved towards the charger C, by rotation. The pin which connects the head T to the charger C can be indifferently constrained (integral or connected) to the charger C (as in figure 2) or to the head T (as in some of the following figures) . When the head T comes into contact with the charger C, it is said that the head-charger group is closed.

After briefly explaining the mechanical structure of an EEA stapler, a very simplified description is provided of the various steps of an intervention that requires the performance of an anastomosis (represented in sequence in figure 3) ;

- isolation of the diseased intestinal segment that must be removed. It is first closed, at a safe distance, with two soft enterostats (pliers that crush non-traumatically ) , so as to prevent the spreading of the intestinal contents;

- removal of the diseased intestinal section, thus forming two intestinal stumps to be anastomosed, proximal and distal;

a tobacco-pouch suture is effected on both the proximal stump and on the distal stump, either manually or using a specific stapler;

- a transverse counter-opening is made on the distal segment, at a few centimetres from the sectioned point, which is sufficient for introducing the rod of the stapler containing the closed head-charger group. The instrument is delicately moved forwards until the head and the charger exits from the stump. At this point, by rotating the handle, the head is removed from the charger, remaining connected to the charger only through the pin;

- the head is thus introduced into the proximal stump where it remains hooded, once the tobacco pouch has been ^'tightened. On the other segment, the closing of the pouch serves to hood the charger;

- a counter-rotation of the knob is then effected so as to progressively move the head towards the charger, bring the two intestinal stumps into contact with each other ;

- once the two segments have come into contact with each other and fit perfectly, the safety catch positioned on the handle of the stapler is removed and the lever is activated. In this way, the blade and the two rows of circular staples are activated, which simultaneously cut and suture the intestine tightened around the pin of the head and charger;

- once the suture had been completed, a counter- rotation of the knob is effected, which moves the head away from the charger to free the sutured edges of the two stumps and the stapler is delicately extracted through the transverse opening which was used for introducing it; - in conclusion, the opening is sutured so as not to create stenosis in the viscus and verifying the anastomosis seal both visually and, whenever possible, by hydro-pneumatic tests.

The anastomosis thus effected may have a postoperative complication which is dehiscence.

Dehiscence generally means the spontaneous reopening of a previously sutured wound. It may be partial, and therefore involve one or some suture points, or complete. A very serious form is that of laparotomy wounds, where the complete opening of all the wall layers involves the outflow of the viscera movable outside the abdominal cavity or evisceration. The causes of this complication are the same as those that slow down the healing process of wounds:

local: infections, ischemic states,

systemic: diabetes, cancer diseases, cough infections, dysproteinaemias , cachettic states, cortisone or antineoplastic drug therapies, obesity.

Among the causes of dehiscence, the breakage of the suture materials and laceration of the tissues due to abnormal tension (coughing, excessive strain, incongruous movements) can also be mentioned; these situations, however, only occur in the case of surgical technique errors (incorrect positioning of the wound edges) or due to the use of improper suture materials.

The severity of the clinical picture is extremely variable and depends on various factors such as the extent of dehiscence and the seat or organ concerned: the dehiscence of a skin wound and therefore superficial does not entail particularly serious problems, the dehiscence of a suture in the large cavities of the body can be fatal. The even partial dehiscence of an anastomotic suture on the esophagus or rectum, in fact, results in the external spreading of endo-luminal material with consequent mediastinitis or peritonitis that may be fatal. Analogously, even minimal dehiscence, but with respect to particular organs, such as an arterial vessel, sometimes cause uncontrollable bleeding.

Anastomotic dehiscence remains the most fearful complication even after the introduction of MS, to such a degree that in the case of intestinal anastomosis, in a fair number of cases, a divergent ostomy is performed (whereby the feces are caused to exit upstream from the abdominal wall) to protect the anastomosis downstream.

The objective of the present invention is to find a reinforcement and protection element for anastomosis, in a bioreabsorbable material, that overcomes the drawbacks of the known art. More specifically, the objective of the present invention is to find a reinforcement and protection element for anastomosis, which minimizes the post- operatory complication of dehiscence.

An object of the present invention therefore relates to a reinforcement and protection element for anastomosis, in a bioreabsorbable material, comprising at least one substantially cylindrical body having an open end and having, at the opposite end, an axially perforated base, said element being characterized in that the open end has an edge having a jagged form with petal elements or a star-shaped form, said reinforcement and protection element being suitable for being positioned on a mechanical stapler for anastomoses.

Said reinforcement and protection element for anastomosis, in a bioreabsorbable material, can also comprise an axially perforated diaphragm, in bioreabsorbable material, suitable for being positioned on a mechanical stapler for anastomoses, preferably a circular, crown-shaped diaphragm.

The axial hole present in the perforated base of the reinforcement element and in the diaphragm is characterized by having dimensions which are such as to allow the passage of the connection pin of a head- charger group of the mechanical stapler.

The reinforcement and protection element according to the present invention significantly reduces the incidence of complications of dehiscence, as it reinforces the suture effected manually or mechanically, using substantially inert materials which increase the resistance of the grip of the staples.

At the same time, the reinforcement and protection element according to the present invention allows the anastomotic line to be protected by overlaying it with an internal cylinder of bioreabsorbable material, which isolates the suture from the fecal content.

The diaphragm element, when present, further reinforces the suture as it produces an intermediate disc between the two stumps or hollow viscus section, said disc allowing the staples to adhere better to the tissue of the organ to be sutured and grip sections having a better consistency.

The bioreabsorbable material is preferably selected from:

- synthetic plastic materials that can only be eliminated in the long term;

- biological prostheses (collagen matrices) deriving from decellulari zed animal tissues, which stimulate/facilitate repair within the host before being reabsorbed.

The material of the reinforcement and protection element for anastomosis according to the present invention must be characterized by a flexibility, form or thickness which allow its positioning on the mechanical stapler and subsequent use as a reinforcement and protection element for anastomosis.

Furthermore, this material allows the repair and synthesis of the tissues to be guided and disappears with time, after performing its function.

More specifically, the edge having a jagged form of the open end of the -substantially cylindrical body has petal elements arranged along the whole perimeter of the edge.

The edge of the open end of the substantially cylindrical body is suitable for allowing the open end of the reinforcement element to be connected/fixed to the head and moved by the same head of the mechanical stapler .

More specifically, the edge is suitable for allowing the open end of the reinforcement element to be connected/fixed to the head and moved by the same head of the mechanical stapler, as it interacts with the fixing and movement means present on the head that bring the reinforcement element with a substantially cylindrical body from the "open" position to the "closed" position, wherein the open end is in fact closed. Subsequently, on positioning the head in abutment on the inner side of the base or end of the axially perforated cylindrical body, the cylindrical body of the reinforcement element is overturned and is suitably positioned for effecting the subsequent application phases to the stapler itself.

This positioning of the element on the head of the stapler and then on the stapler, moreover, also allows the correct positioning with respect to the two segments of hollow viscus subjected to anastomosis, thus arranging the reinforcement and protection element according to the present invention in its operating position.

The use is also described of a bioreabsorbable material in reinforcement and protection elements for anastomosis, wherein said material is selected from

- synthetic plastic materials;

- biological prostheses deriving from decellularized animal tissues.

The bioreabsorbable material is preferably a non- crosslinked collagen matrix.

In particular, the synthetic plastic materials are synthetic plastic materials that can only be eliminated in the long term, whereas the biological prostheses (collagen matrices) deriving from decellularized animal tissues stimulate/facilitate repair within the host before being reabsorbed.

An object of the present invention also relates to the use of a substantially cylindrical body having an open end and having, at the opposite end, an axially perforated base, suitable for being positioned on a mechanical stapler for anastomosis, as a reinforcement and protection element for anastomosis, said element being characterized in that the open end has an edge having a jagged form with petal elements, or a star- shaped form.

Finally, an object of the present invention relates to a method for the application of a reinforcement and protection element, substantially cylindrical, having an open end and having, at the opposite end, an axially perforated base, and possibly also comprising an axially perforated diaphragm, to a mechanical stapler, preferably an EEA stapler, said method comprising the following steps:

- the substantially cylindrical reinforcement and protection element is inserted, by means of the axially perforated base, on a connection pin between the head and charger of a head-charger group of the stapler, the open end of the cylindrical body of the reinforcement element being connected to the head by means of suitable fixing/gripping and movement means provided on the same head, said head-charger group being in an open position, with the head and charger not connected by the connection pin constrained to one of the two;

- the axially perforated diaphragm, if present, is inserted on the connection pin by means of the axial opening present therein, in such a position as to be interposed between the end with the axial opening of the reinforcement element having a cylindrical body and the charger;

- the head is then positioned in abutment on the inner side of the base or end of the axially perforated cylindrical body, closing the open end and overturning the cylindrical body of the reinforcement and protection element, due to the effect of the action of the fixing/gripping and positioning means present on the head itself;

- the head-charger group, also comprising the reinforcement and protection element thus positioned, is then brought in a closed position by connection through the connection pin and rotation of the same with the progressive approaching of the head and charger until they are in contact with each other or in contact with the diaphragm, if present.

In the enclosed figures:

figures 1-3 show, as already discussed, the state of the art with reference to what is meant by anastomosis, the structure of a mechanical stapler (EEA) and the method of use of said EEA for performing an anastomosis;

figures 4-5 show two embodiments of a reinforcement and protection element according to the invention, with perspective views of the reinforcement element with a substantially cylindrical body in an open and closed position, and a plan view of the reinforcement element and relative diaphragm;

figures 6A and 6B show the first application phase of the reinforcement element according to the present invention to the mechanical stapler;

figures 7-10 show a sequence of phases relating to an anastomosis effected with a mechanical stapler on which the reinforcement and protection element according to the invention is positioned;

figure 11 shows a second anastomosis performed with a mechanical stapler on which the reinforcement and protection element according to the invention is positioned; figures 12-23 show the sequence of phases relating to the performance of an anastomosis such as that shown in figure 11, obtained with a mechanical stapler on which the reinforcement and protection element according to the invention is positioned.

Whereas the invention can undergo various modifications and alternative constructions, some preferred embodiments are shown in the drawings and are described in detail hereunder.

It should be understood, however, that there is no intention of limiting the invention to the specific embodiments illustrated, but, on the contrary, it intends to cover all the modifications, alternative constructions, and equivalents that fall within the scope of the invention as defined in the claims.

The use of "for example", "etc", "or" indicates non-exclusive and alternatives without limitation unless otherwise specified.

Indications such as "vertical" and "horizontal", "upper" and "lower", "inner" and "outer" should be read with reference to the assembly (or operating) conditions and with reference to the normal terminology used in current language, wherein "vertical" indicates a direction substantially parallel to that of the force of gravity vector "g" and horizontal a direction perpendicular to the same.

In particular, according to a first embodiment, the reinforcement and protection element 10 according to the present invention is characterized by the structure represented in figure 4A with a substantially cylindrical body 11 having an open end 12, with petal elements 14, and having, at the opposite end, a base 13 axially perforated 15.

More specifically, in figure 4A, the reinforcement element is represented in a "closed" position, in figure 4B, the reinforcement element is in an "open" position, figure 4C is a plan view of said reinforcement element in an "open" position and figure 4D is . a plan view of a diaphragm for the element of figure 4A.

The axially perforated 17 diaphragm 16 of figure 4D has a circular crown structure 18, but it may also have an outer edge analogous to that of the open end of the cylindrical body. The outer edge of the diaphragm can also have a jagged petal-shaped form.

Figures 5A and 5B show the reinforcement element according to the present invention in an "open" position and in a "closed" position in a second embodiment .

The embodiments of the reinforcement and protection element according to figure 4 or according to figure 5 have an edge of the open end 12 with petal-shaped elements 14, suitable for helping to reach the closed position and subsequent inward overturning of the cylindrical structure itself due to the action of the fixing/gripping and movement means present in the head 19 of the mechanical stapler and subsequent movement of the connection pin 21 between the head 19 and charger 22 which moves the head 19 towards the same charger 22 of the head-charger group 23 of the mechanical stapler.

The reinforcement and protection element according to the present invention can be positioned on the stapler which then effects the anastomosis according to the following exemplifying procedure.

More specifically, the reinforcement element represented in figure 4 or in figure 5 is applied to the mechanical stapler as indicated by the sequence of phases of figures 6A and 6B: the open end 12 of the cylindrical body 11 of the reinforcement element 10 is fixed to the head 19 of the head-charger group of a mechanical stapler, using suitable fixing/gripping and ring-movement means 20.

The pin 21, which will subsequently connect the head 19 to the charger 22, is inserted in the perforated base 13 through the axial hole 15 of the other end of the reinforcement element 10.

The reinforcement element 10 is therefore inserted in the connection pin 21 of the head-charger group 23 through the end provided with an axial opening 13, i.e. the perforated base, whereas the open end 12 is fixed to the head 19 by said fixing/gripping and movement means 20 which are fixed to the edge 12. The head 19 is then positioned in abutment on the inner side of the base or end of the axially perforated 13 cylindrical body 11, as shown in figure 6B: on reaching this position, the head 19 closes the open end 12 of the cylindrical body 11, moving the petals 14 that form the edge, towards each other, and the cylindrical body 11 of the reinforcement and protection element 10 overturns due to the action of the fixing/gripping and movement means 20, as shown in figure 6B, and is suitably positioned to effect the subsequent application phases to the stapler itself.

The axially perforated diaphragm 16 will also be inserted on the pin 21 which connects the head 19 and charger 22, if provided, through the axial opening 17 present therein: said diaphragm 16 is inserted in such a position as to be interposed between the end with an axial opening 13 of the reinforcement element 10 having a cylindrical body 11 and the charger 22. The head 19 is then re-connected by means of said pin 21 to the charger 22 and the head-charger group 23, also comprising the reinforcement and protection element 10 according to the present invention, positioned as previously described, is then closed by rotating the knob (not shown in the figure), and the stapler thus prepared is used for effecting the desired anastomosis .

More specifically, the stapler thus prepared with the reinforcement and protection element according to the present invention, is inserted in the hollow viscus, object of the anastomosis, for example according to what is shown in the previous figure 3, where a tobacco-pouch suture is obtained on both the proximal stump 24, and on the distal stump 25, either manually or using a specific stapler; a transverse counter-opening (reference 26, in figures 3 and 11) is then effected on the distal segment 25, a few centimetres from the sectioned point, which is sufficient for introducing the rod of the stapler containing the head-charger group in a closed position, also comprising the reinforcement and protection element according to the present invention, positioned as previously described.

The introduction of the stapler can also be effected through the anal opening (reference 26' in figure 7) when the anastomosis relates to the lower rectum .

The instrument is gently moved forward until the head 19 and the charger 22 come out of the distal stump 25.

At this point, by rotating the knob (not shown in the figure), the head 19 is removed from the charger 22, only remaining connected to the same through the pin 21; the head 19 with the reinforcement and protection element 10 having a cylindrical body 11, positioned as described above, is thus introduced into the proximal stump 24 where it remains hooded, once the tobacco-pouch suture has been tightened.

The axially perforated diaphragm 16, inserted on the connection pin 21 and positioned between the end with an axial opening 13 of the reinforcement element 10 having a cylindrical body 11 and the charger 22, is positioned externally with respect to the proximal stump 24, and also externally with respect to the distal stump 25. The closing of the tobacco-pouch suture for hooding the charger 22 is also effected on this distal stump or segment 25.

This positioning of the stapler and reinforcement and protection element according to the present invention is shown in figure 7.

A counter-rotation of the knob is then effected in order to progressively move the head 19 towards the charger 22, bringing the two intestinal stumps 24 and 25 in contact with the diaphragm 16 of the reinforcement and protection element according to the present invention (or in contact with each other in embodiments in which the diaphragm is not provided) . Figure 8 then shows the subsequent position of the reinforcement and protection element 10 according to the present invention, after activating the blade and the two rows of circular staples present in the charger 22 and not shown in the figure, which simultaneously cut and suture the two stumps 24 and 25 of the intestine, the perforated base of the reinforcement and protection element 10 and the diaphragm 18 of the reinforcement and protection element 10, tightened around the pin 21, by head 19 and charger 22, once the head 19 and charger 22 have been removed and once the stapler has been gently extracted through the opening 26', which was used for its insertion.

The fixing and movement means 20 of the head 19 of the stapler simultaneously act on the reinforcement and protection element 10 with a cylindrical body 11 and said element 10, fixed to the proximal stump 24 by the staples, is completely folded/overturned on itself. More specifically, the edge of the portion of the perforated base 13 of the element 10, fixed to the proximal stump 24 by the staples, is folded on itself, whereas the cylindrical body 11 is completely overturned on itself.

The element 10 is thus brought from a position in which it is only present in the proximal stump 24, represented in figure 7, to a position in which the element 10 has the edge of the portion of the perforated base 13 of the element 10, fixed to the proximal stump 24 by the staples, folded over itself still in the proximal stump 24, whereas the cylindrical body 11 overturned on itself is in the distal stump 25, as shown in figure 8, where the element with a cylindrical body 11 and the diaphragm 18 reinforce the wall of the anastomosis, protecting it from dehiscence.

The sequence of phases illustrated in figures 7-10 relate to an anastomosis of the lower rectum where the insertion and extraction of the mechanical stapler do not require the application of a transverse counter- opening, but are effected through the anal opening 26' . They show the phases previously described and the subsequent positioning of the reinforcement and protection element 10 according to the present invention, once the stapler has been removed (figures 9 and 10) .

As previously observed, figure 11 shows a second anastomosis effected with a mechanical stapler on which the reinforcement and protection element 10 according to the invention is positioned.

The sequence of phases is completely analogous to that described with reference to figures 7-10 with the only difference that the introduction of the stapler is effected in the distal segment 25, through a transverse counter-opening 26 which is sufficient for introducing the rod of the stapler containing the head-charger group 23 in a closed position, also comprising the reinforcement and protection element 10, positioned as previously described.

In particular, the sequence of phases for performing an anastomosis such as that shown in figure 11 is shown schematically and exclusively as an example in figures 12-23, wherein figures 12 and 13 show the positioning phases of the reinforcement and protection element according to the present invention on the stapler .

Figure 14 shows the two proximal and distal stumps of the section of hollow viscus, with the two tobacco- pouch sutures and with the transverse counter-opening, whereas figures 15-17 show the gradual insertion of the stapler, through the transverse counter-opening, into the hollow viscus, until the head on which the reinforcement and protection element according to the present invention is positioned, has been inserted in the proximal stump, the diaphragm of the reinforcement and protection element in the free space between the proximal stump and the distal stump and the charger of the stapler in the distal stump (figure 17).

The tobacco-pouch sutures are then closed (figure

18) and with a counter-rotation of the knob of the stapler so as to progressively move the head towards the charger, bringing the two intestinal stumps in contact with the diaphragm of the reinforcement and protection element according to the present invention ( figure 19) .

Figure 20 then shows the subsequent position of the reinforcement and protection element according to the present invention, after activating the blade and the two rows of circular staples present in the charger, which simultaneously cut and suture the two stumps of the intestine, the perforated base of the reinforcement and protection element and the diaphragm of the reinforcement and protection element, whereas figures 21 and 22 show the sequence of phases that bring the reinforcement and protection element in the correct operating position inside the hollow viscus due to the extraction movement of the stapler through the opening, which was used for its insertion. Figure 23 shows the two stumps, once the anastomosis has been effected, the stapler extracted and the transverse counter-opening closed .

The objectives listed above have thus been achieved .

Numerous variants to what has been described so far are obviously possible.

With reference to the materials used in the reinforcement and protection element according to the present invention, and specifically the synthetic plastic materials and biological prostheses, preferably collagen matrices deriving from decellulari zed animal tissues, it should be remembered that the synthetic plastic materials are synthetic plastic materials that are only eliminated in the long term, whereas the biological prostheses (collagen matrices) deriving from decellulari zed animal tissues stimulate/facilitate repair within the host before being reabsorbed.

Collagen matrices, also called bioprostheses or biological prostheses, are fundamentally materials of animal (mammals) or human origin, known and currently used for implants in patients in some particular situations (for example in abdominal hernias complicated by an infection or contaminated by high- load septic materials, such as feces or enteric liquid) (as described in Review of M. Hiles et al. "Are biologic grafts effective for hernia repair? A systematic review of the literature." Surg. Innov, 16 (2009) , pages 26-37.

These materials have been known and commercialized for two decades but have never been described nor suggested in the use for a reinforcement and protection element for anastomosis.

Although collagen matrices can vary on the basis of their origin (human or animal, and porcine, equine or bovine animal), composition (dermis, pericardium or intestinal submucus: all tissues rich in collagen fibers) and treatment modes (stripping, cross-linking), they are all characterized by being decellulari zed biological tissues. These are therefore biological grafts wherein the collagen matrix is made acellular to facilitate its incorporation in the host tissues with the intent of rebuilding the damaged native tissue. The main objective is to provide the extracellular components necessary for completing the healing process, allowing the reconstruction of new and healthy tissue, and restoring the mechanical and functional integrity of the original tissue. This mechanism is based on the presence within these matrices of two fundamental components, collagen and growth factors: the former behaves like a scaffold inside which, through the revascularization process, the host cells settle and rebuild a neo-tissue, whereas the latter stimulate the angiogenesis process and remodelling of the matrix. In practice, it is what is called tissue engineering. In particular, the mechanism described takes place in non-crosslinked matrices: there are also matrices in which the collagen fibers are subjected to a cross-linking process (i.e. increase in bonds between the collagen fibers) which, by increasing the "cross- linking" of the collagen, increases the strength of the biological graft. In the case of cross-linked matrices, in fact, the collagen fibers are less exposed to the action of collagenases (enzymes which degrade the same collagen to subsequently enable a reconstruction with the deposition of neo-collagen) . In this case, as the density of the "cross-linking" of the collagen increases, in addition to there being an increased strength and stability of the implant, there is also a decrease in the cellular infiltration degree (with reduced angiogenesis), an increased encapsulation by fibroblasts, a greater resistance to degradation by the host, and consequently with a lower possibility of incorporating the implant into the host. Biological grafts which undergo "cross-linking" (cross-linking of collagen) are in fact capable of stimulating or maintaining cellular growth factors for promoting angiogenesis only to a lesser extent. This results in a reduced incorporation of the grafting and permanence of this graft as a residual foreign body in the host. In the case therefore of the reinforcement and protection element according to the present invention, the use of non-crosslinked collagen matrices from decellularized animal tissues is preferred.

Specific examples of materials to be used in the reinforcement and protection element according to the present invention are the following non-crosslinked matrices :

Tabella 1

Biological prosthesis currently on the market

Name Manufacturer Tissue source Material linking

Alloderm LifeCell Human Acellular dermis No

AlloMax Bard Human Acellular dermis No

Flex HD Ethiccfi/MTF* Human Acellular dermis

Derma Matrix Human Acellular dermis No

Permacol Covidien Porcine Acellular dermis Yes

CollaMend Davol/Bard Porcine Acellular dermis Yes

Strartice KCIAifeCell Porcine Acellular dermis No

XenMatrix Brennan Medical Porcine Acellular dermis No

Surgisis Cook Porcine Small intestine submucosa No

Surgisis Gold Cook Porcine Small intestine submucosa No

Lyosis Cook Porcine Lyophilized small intestine submucosa No

FortaGen Organogenesis Porcine Small intestine submucosa Yes

SurgiMend TFJ bioscience Bovine Fetal dermis No

Periguard Synovis Bovine Pericardium Yes

Veritas Synovis Bovine Pericardium No

Tutomesh Tutogen Bovine Pericardium No

Tutopatc Tutogen Bovine Pericardium No

Coccolini et al. World Journal of Imergency Surgery 2012, 734 http://www.wjes /content/7/1 /34

Claims

1. A reinforcement and protection element (10) for anastomoses, produced in a bioreabsorbable material, comprising at least one substantially cylindrical body (11) having an open end (12) and having, at the opposite end, an axially perforated base (13), said element (10) being characterized in that the open end (12) has an edge having a jagged form with petal elements (14) or a star-shaped form, said reinforcement and protection element (10) being suitable for being positioned on a mechanical stapler for anastomoses.

2. The element according to claim 1, also comprising an axially perforated (17) diaphragm (16), produced in a bioreabsorbable material, suitable for being positioned on a mechanical stapler for anastomoses, preferably circular crown-shaped.

3. The element according to one or more of the previous claims, wherein the bioreabsorbable material is selected from:

- synthetic plastic materials;

— biological prostheses, such as collagen matrices, deriving from decellularized animal tissues.

4. Use of an element having a substantially cylindrical body (10) having an open end (12) and having, at the opposite end, an axially perforated base (13), suitable for being positioned on a mechanical stapler for anastomoses, as reinforcement and protection element for anastomoses, said element (10) being characterized in that the open end (12) has an edge having a jagged form with petal elements (14) or a star-shaped form.

5. An application method of a reinforcement and protection element (10), substantially cylindrical, having an open end (12) and having, at the opposite end, an axially perforated base (13), and possibly also comprising an axially perforated (17) diaphragm (16), with a mechanical stapler, preferably an EEA stapler, said method comprising the following phases:

- the reinforcement and protection element (10), substantially cylindrical, is inserted, by means of the axially perforated base (13), on a connection pin (21) between the head (19) and charger (22) of a head- charger group (23) of the stapler, the open end (12) of the cylindrical body (11) of the reinforcement element (10) being connected to the head (19) by means of suitable fixing/gripping and movement means (20) provided on the same head (19), said head-charger group (23) being in an open position, with the head (19) and charger (22) not connected by the connection pin (21) constrained to one of the two;

- the axially perforated diaphragm (16), if present, is inserted on the connection pin (21) by means of the axial opening (17) present therein, in such a position as to be interposed between the end with the axial opening (13) of the reinforcement element (10) having a cylindrical body (11) and the charger (22);

- the head (19) is then positioned in abutment on the inner side of the base or end of the axially perforated cylindrical body (13), closing the open end (13) and overturning the cylindrical body (11) of the reinforcement and protection element (10), due to the effect of the action of the fixing/gripping and positioning means (20) present on the head itself (19);

- the head-charger group also comprising the reinforcement and protection element thus positioned, is then brought in a closed position through connection by means of the connection pin and rotation of the same with the progressive approaching of the head and charger until they are in contact with each other or in contact with the diaphragm, if present;

- the head (19) is then positioned in abutment on the inner side of the base or the end of the axially perforated cylindrical body (13), overturning the cylindrical body (11) of the reinforcement and protection element (10) which closes towards the interior due to the effect of the action of the fixing/gripping and positioning means (20) present on the head itself (19) ;

the head-charger group (23), also comprising the reinforcement and protection element (10) thus positioned, is then brought to a closed position through connection by means of the connection pin (21) and by rotation of the same with the progressive approaching of the head (19) towards the charger (22) until they are in contact with each other or in contact with the diaphragm, if present.