ITPI20090075A1 - DEVICE AND METHOD FOR THE SURGICAL TREATMENT OF A COMPLEX PERIANAL FISTULA - Google Patents

Description

`` DEVICE AND METHOD FOR THE SURGICAL TREATMENT OF A COMPLEX PERIANAL FISTULA ...

Description

Scope of the invention

The present invention is placed in the field of surgery and related surgical instruments, and more precisely it refers to a device and a relative method for the surgical treatment of a complex perianal fistula.

Description of the prior art

As known, an anal fistula is a â € œchannelâ € that has an internal orifice, located in the rectum or in the anal canal, a more or less complex path and an external orifice located at various levels on the perianal or perineal skin. The dentate line separates the anal canal from the rectum and contains the cryptoglands from one of which the first infection originates. Later, from it, the fistula will form.

The sphincter system is composed of the internal anal sphincter, external anal sphincter and the levator ani muscle (figure 1). The classification of anal fistulas is based on the relationships that the fistula contracts with the sphincters themselves and their spaces. Thus we distinguish the submucosal, intersphincteric, transsphincteric, extrasphincteric or supraphinteric and "horseshoe" fistula (figure 2). The first two types of fistula (submucosal and interspherical) are called â € œsimpleâ € as they can be treated in an outpatient clinic and under local anesthesia. The other types of fistula, on the other hand, are called â € œcomplexâ € as they involve the sphincters at various levels and require sometimes complex surgical treatments that put the mechanisms of fecal continence at risk. They also have a high rate of relapse and complications.

From the diagnostic point of view, at present, the most appropriate examination for the preoperative diagnosis of the type of fistula is the transanal ultrasound which has a reliability of 80%. Fistulography, once considered the diagnostic method of choice, is no longer performed. More recently nuclear magnetic resonance has been proposed for the preoperative classification of fistulas but is still an expensive and often insufficient examination.

The surgical techniques that are currently performed for the treatment of complex anal fistulas are varied. The most common are:

â ’fistulectomy with the packaging of a mucous flap to close the internal orifice of the fistula and the application of setons with the intention of slowly dissecting the sphincters to prevent incontinence.

â € œthe insertion, in the fistulous path, of a â € œplugâ € in a lyophilized porcine intestine submucosa which, given the alleged antibacterial and regenerative characteristics, should close the fistula in a short time.

∠’Insertion, in the fistulous path, of fibrin glue.

∠’Insertion, in the fistulous path, of cyanoacrylate. ∠’LIFT: ligation of the interstitial tract of the fistula.

â ’In the most serious cases, a temporary colostomy is made to â € œdeviateâ € the course of the stool and prevent it from passing through the fistula.

The various techniques mentioned above present some still unsolved problems. Meanwhile, with the exception of simple fistulas, since these are complex fistulas, surgical correction leads to healing in 50% of cases, this is already considered an excellent result. More often, however, the patient has to undergo two or three operations (interventions planned in two or more times), very frequently followed by relapse.

The causes of the recurrence are commonly known: the mucous flap that is packaged to close the internal orifice of the fistula (located in the anal canal or rectum) yields, so that the faeces, or in any case the fecal bacteria, can repopulate the fistula, perpetuating it infection. A first problem of the pre-existing techniques, therefore, is the imperfect closure of the internal fistulous orifice.

This problem also arises in the application of the â € œplugâ €, that is the porcine intestinal submucosa cone that is fixed with sutures to the internal orifice of the fistula, which orifice must be hermetically closed, otherwise it will recur.

Even the application of fibrin glue inside the fistula did not give encouraging results (relapses greater than 80%) so it was abandoned. The application of cyanoacrylate instead gave much more encouraging results with successes exceeding 50% but, alone, does not currently seem to represent the method of choice.

On the other hand, the LIFT method (ligation of the intersphincteric tract of the fistula) is very recent, which can also be performed on an outpatient basis: it consists in making a small incision between the two internal and external sphincters, isolating the interstitial tract of the fistula and tying it in order to guarantee closure of the fistula itself. There are still no reliable results in the literature. If nothing else, this method reaffirms the need for a hermetic closure of the fistula, in this case in its interspersal tract instead of its internal orifice. In any case, the successes of this method are reported to be around 60-70% but still to be confirmed. In the techniques described above, therefore, it is the high rate of relapse which varies, depending on the technique, from 30 to 80%.

Another problem of traditional techniques that involve the packaging of a mucous flap and / or the application of setons, are often large and disfiguring surgical wounds (figure 3) which must be constantly medicated with very long healing times (even months ). In addition to accepting large and painful wounds, the patient is not even sure of healing due to the high rate of recurrence. The fact is that, despite months of medications and visits, the fistula does not heal and indeed, after a short time, it recurs. From this also derives the discomfort of the surgeon himself who, despite his work, may find himself in the need to propose to the patient another surgery or even a colostomy in order to heal the fistula.

A third problem with traditional techniques is that at the beginning of the operation the fistulous path is identified by means of a metal probe that runs through it to the internal orifice. Due to the sinuosity of the fistula and the pointed shape of the instrument sometimes â € œfalse pathwaysâ € are created which do not follow the fistula and which can represent further causes of recurrence as well as constituting an incorrect surgical treatment.

A further problem is the risk of sphincter lesions in an attempt to completely remove the fistula or in any case the granulation tissue inside the fistula itself. Traditional interventions (flap and setone) are in fact today burdened by a fair rate of postoperative fecal incontinence (20-50% depending on the case).

A fifth problem is of a diagnostic type and in terms of hospitalization. In fact, since the classification of perianal fistulas is very complex, the surgeon needs to perform preoperative diagnostic tests such as transanal ultrasound, magnetic resonance or fistulography. As far as hospitalization is concerned, the national average hospital stay for complex fistulas is about 3 days, while it would be desirable to have interventions that require shorter times, preferably with daily hospitalization.

A further problem is the resumption time of work activities which varies, depending on the case, from 10 days to 3 months.

Summary of the invention

It is therefore a general purpose of the present invention to provide a device and a method for the surgical treatment of complex anal fistulas (transphinteric, extrasphinteric and supra-transphragmatic) and in cases of recurrence of the fistulas themselves which solves the aforementioned problems, in particular allowing an easy and correct identification. of the internal fistulous orifice, allowing the treatment of the fistula without causing damage to the sphincters, and a drastic reduction in recurrences.

It is a particular aim of the present invention not to require the preoperative diagnostic phase, with a considerable saving of time and resources, and less inconvenience for the patient.

In a first aspect of the invention, a device is provided for the surgical treatment of a complex perianal fistula, said fistula having an external cutaneous orifice, an internal intrarectal orifice and a complex path comprised between said orifices. Such a device includes:

∠’an operating block that can be challenged by an operator; ∠’an elongated body removably connected to said operating block and having a blunt end on the opposite side to said operating block;

∠’an optical element for scopes provided at said blunt end, said optical element for scopes being connected, by means of optical fibers that pass along said elongated body, to a point of visual connection on the operating block,

∠’an operating channel present longitudinally in said elongated body, said operating channel having an inlet on the side of said operating block and an outlet in correspondence with said blunt end;

â 'said elongated body being such as to be introduced into said fistula by introducing said blunt end into the external orifice, and then such as to follow the complex path of the fistula, with the aid of the scope through said optical element, until said blunt end reaches said internal orifice and flows into the rectum.

In this way, thanks to the blunt tip and the fluoroscopy, the elongated body can be passed into the fistula, without creating `` false roads '' and reaching the internal orifice in order to identify it and allow the surgeon to mark it, avoiding a phase preoperative diagnostics. Moreover, thanks to the operative channel, various surgical and therapeutic operations can be performed in the fistula, by positioning the blunt tip at any point of the fistula.

To make the scope operational, an optical fiber cable is provided, connected to the visual connection point on the operating block, and then connected to a monitor vision system.

Preferably, the elongated body is substantially rigid so as to be able to pass through the perianal fistula internally from its external cutaneous orifice to its internal intrarectal orifice, in such a way as to substantially â € œrectilineizeâ € said fistula between said two orifices. In this way, the muscle tissue, which is soft following anesthesia, adapts to the elongated body and said optical element allows the complex anal fistula to be followed by means of a scan up to said internal orifice, suitably orienting said elongated body by action from the external via said operating block.

Advantageously, said elongated body is associated with a cauterizing device, able to be introduced through said inlet into said operating channel up to said blunt end, protruding from said outlet. In this way, it is possible to actuate said cauterization device and cauterize the internal walls of said fistula between said internal orifice and said external orifice by retracting said elongated body so that said blunt end moves between said internal orifice and said external orifice.

Advantageously, said elongated body is associated with a mechanical removal device of cauterized tissue inside said fistula, able to be introduced through said inlet into said operative channel up to said blunt end, protruding from said outlet mouth . In this way, it is possible to alternately rotate or translate said elongated body and scrape the internal walls of said fistula between said internal orifice and said external orifice, detaching portions of cauterized tissue.

Advantageously, said elongated body is associated with a washing liquid injection device, for example saline solution, adapted to be injected through said inlet into said operative channel until it reaches said outlet and flows into said fistula. In this way, it is possible to operate said injection device and wash the internal walls of said fistula between said external orifice and said internal orifice, causing said liquid to proceed along said fistula until it emerges into the rectum through said internal orifice.

Advantageously, said device is associated with a suturing machine adapted to close said internal orifice by means of sutures. In particular, when said blunt tip of said elongated device exits from said internal orifice, the edges of said internal orifice are identified, and then raised so that said suturing machine, introduced via the anus, can grasp said edges and close said edges. edges.

In a second aspect of the invention, a method is provided for the surgical treatment of a complex perianal fistula, said fistula having an external cutaneous orifice, an internal intrarectal orifice and a complex path included between said orifices. Such a method includes the steps of:

- provide an elongated body removably connected to an operating block and having a blunt end on the opposite side to said operating block, in which said elongated body has an optical element for scanning in correspondence with said blunt end, and also has an operating channel longitudinal having an inlet on the side of said operating block and an outlet in correspondence with said blunt end;

â 'pass said elongated body into said fistula by introducing said blunt end into the external orifice, and following said blunt end the complex path of the fistula, with the aid of a scan through said optical element, until said end blunt reaches said internal orifice and flows into the rectum.

- introducing a cauterization device into said operative channel until it reaches said blunt end and protrudes from said outlet, and cauterizes the internal walls of said fistula between said internal orifice and said external orifice by retracting said elongated body so that said blunt end moves between said internal orifice and said external orifice;

- remove the cauterized tissue inside said fistula, introducing a mechanical removal device into said operative channel up to said blunt end, and alternately rotate or translate said elongated body to scrape the internal walls of said fistula between said internal orifice and said external orifice, detaching portions of cauterized tissue;

- injecting washing liquid, for example saline solution, into said operating channel until it reaches said outlet mouth and flows into said fistula, and washing the internal walls of said fistula between said external orifice and said internal orifice, causing said liquid along said fistula until it flows into the rectum through said internal orifice;

∠’close said internal orifice with sutures using a suturing machine;

- to introduce into said fistula, through said external orifice, a material suitable for welding the internal walls of said fistula.

Advantageously, when said blunt tip of said elongated device exits from said internal orifice, the edges of said internal orifice are identified, and then raised so that said suturing machine, introduced via the anus, can grasp said edges and close said edges. .

Preferably, the elongated body is substantially rigid in order to be able to internally travel the perianal fistula from its external cutaneous orifice to its internal intrarectal orifice, in such a way as to substantially â € œrectilineizeâ € said fistula between said two orifices, making the muscle tissue adapt, which results soft following anesthesia, to the elongated body and guiding the elongated body, which can be rigidly orientated from the outside in the form of a â € œsock ironâ €, thanks to the scope that allows you to follow the complex anal fistula up to said internal orifice.

Brief description of the drawings

In the attached drawing sheets:

∠’figure 1 shows the human sphincter apparatus;

â ’Figures 2A-2E show the various types of anal fistula, respectively the submucosal, inter-sphincteric, transphinteric, extra-sphincter or supra-sphincter and horseshoe fistula;

∠’Figures 3A-3D show traditional techniques that involve the packaging of a mucous flap and / or the application of bristles, with often large and disfiguring surgical wounds;

â ’Figure 4 shows a device according to the invention with the blunt end introduced through the external orifice into an anal fistula; - Figures 4A and 4B show the elongated body of the device according to the invention respectively in partial longitudinal section view and in front view from the side of the blunt tip;

Figures 5 and 5A show the device according to the invention which runs through an anal fistula with the blunt end located in an intermediate position between the external and internal orifice, and the scope that allows to follow the path of the fistula;

Figures 6 and 6A show the device according to the invention with the blunt end of the elongated body that emerges in the rectum coming out of the internal orifice, and the scope that allows to understand the reaching of the rectum;

figure 7 shows a phase of marking the edges of the internal orifice while the blunt end of the elongated body is still in the position of figures 6 and 6A;

Figures 8, 8A and 8B show the device according to the invention in the step of cauterizing the internal walls of the fistula;

figure 9 shows the step of lifting the edges of the internal orifice, to prepare for the suturing of these edges;

Figures 10 and 11 show a stapler associated with the device according to the invention in the step of suturing the edges;

figures 12 and 12A show the fully sutured internal orifice;

figure 13 shows in the photograph the external orifice at the end of the operation, and the absence of surgical scars on the perineal skin;

Figure 14 illustrates the device according to the invention in the liquid injection phase; Figure 14 illustrates the device according to the invention in the liquid injection phase;

- Figure 15 illustrates a detail of the operating block the invention in the phase of injection of liquid through the operating block into the canal of the elongated body until it comes out into the fistula;

- Figure 16 illustrates the cauterization means, which can be inserted into the elongated body through the operating block until it comes out of the elongated body into the fistula;

- Figure 17 illustrates the mechanical means of mechanical removal of the cauterized tissue, which can be inserted into the elongated body through the operating block until it comes out of the elongated body into the fistula and scrapes the cauterized tissue;

∠’Figures 18A and 18B illustrate a retractor for accessing the internal orifice of the fistula via the anal route;

- Figure 19A illustrates a fenestrated anoscope and its introducer, and Figure 19B shows it in the application position;

∠’figure 20 illustrates the suturing step using a suturing machine according to the invention;

∠’Figure 21 illustrates the step of inserting the glue into the fistula.

Description of the preferred embodiment

The patient is placed in the gynecological position. Spinal anesthesia is performed. A rigid elongated body, or fistuloscope, is used (but it can also be semi-rigid or flexible) which has an optic, an operating channel and an irrigation channel with saline solution. Its ideal diameter is 3.3 X 4.7 mm and it must not be larger in any case. The length of its operating section must not be less than 16 cm. Devices with a diameter of less than or equal to 2.5 mm can be inserted into the working channel. The fistuloscope is connected to a video column and, by means of a special tap, to a bag of saline solution (figure 4).

For the surgical treatment of the fistula 3, which has an external cutaneous orifice 1, an internal intrarectal orifice 2 the device comprises (fig. 4A, 4B):

an operating block 10 that can be gripped by an operator, an elongated body 11 removably connected to the operating block 10 and having a blunt end 12 on the opposite side to the operating block 10,

an optical element 13 for fluoroscopy provided at the blunt end 12, the optical element for fluoroscopy being connected, by means of optical fibers 14 which pass along the elongated body 11, to a visual connection point 15 on the operating block 10,

an operating channel 16 present longitudinally in the elongated body, the operating channel having an inlet 17 on the side of the operating block and an outlet 18 in correspondence with the blunt end 12;

the elongated body 11 being such as to be introduced into the fistula by introducing the blunt end 12 into the external orifice 1, and then such as to follow the complex path 2 of the fistula, with the aid of a scan by means of the optical element 13, until the blunt end 12 reaches the internal orifice 3 and flows into the rectum 4.

Spinal anesthesia guarantees complete muscle relaxation so that, if the rigid fistuloscope 11 is used, the path of the fistula 3, even if tortuous, is â € œrectilineizedâ € by the rigidity of the fistuloscope 11 itself (figure 6).

Diagnostic phase

The aim is to precisely locate the internal orifice 2 of fistula 3.

The elongated body or fistuloscope 11 is inserted through the external orifice 1 of the fistula 3 located on the perianal skin with the jet of saline solution functioning so as to allow the opening of the fistula 3 and the correct view of its interior on the monitor ( figure 5). In this phase, thin endoscopic pliers or the obturator itself of the fistuloscope 11 with a guide function can be used, that is to make it easier to get inside the fistula 3, favoring the progression of the fistuloscope 11 itself and the continuous perfect vision. The surgeon only has to follow the fistulous path 3 clearly visible on the monitor with right-left and up-down movements. The excellent view of the interior of the fistula 3 is guaranteed by the continuous infusion of saline solution until it reaches the rectum 4 or the anal canal with extreme ease through the internal orifice 2. It stands out on the monitor clearly the rectal mucosa is a sign that the optic has passed precisely through the internal orifice 2 which is therefore precisely located (figure 6). The surgeon's assistant places any anal retractor that allows you to see the tip of the fistuloscope 11 protrude into the rectum 4 or into the anal canal through the internal fistulous orifice 2. At this point a transparent horseshoe anoscope is positioned ( which can be fixed to the perianal skin with some sutures) with the open part at the level of the internal orifice 2. This allows the surgeon to â € œinsulateâ € the internal fistulous orifice 2 by applying three or four points with any surgical thread, for example Vicryl® 2/0, on the edges of the fistulous orifice taking as reference the end of the fistuloscope 11 which therefore becomes an important landmark (figure 7).

Operational phase

The aims are the destruction of the fistula 3 from its interior, the removal of necrotic material, the hermetic closure of the internal fistulous orifice 2 and the sealing of the fistula 3 by applying glue.

An electrode, forceps or any other coagulation device connected to an electrosurgical unit is introduced through the operating channel of the fistuloscope 11. Always under direct vision, the surgeon begins to destroy the fistula 3 by cauterizing the granulation tissue of the fistula 3 itself starting from Internal orifice 2, centimeter by centimeter, up to the external orifice 1 (from inside to outside), not forgetting to cauterize any abscess cavities or any second journeys (figure 8). Once the cauterization of the entire internal wall of the fistula 3 has been completed, the surgeon removes the necrotic material by means of a metal brush or a particular device called an endocup or even by means of pliers of various types, all devices in any case having the right diameter to pass through the operative channel of the fistuloscope 11. This procedure favors the activity of the fibroblasts favoring the fibrosis of the fistulous tract 3. Up to this point, the internal fistulous orifice 2 remains open, pulled by the sutures previously applied to isolate it, so that the continuous jet of saline solution favors the escape of the necrotic material in the rectum 4 through the internal fistulous orifice 2. The rectum 4 is therefore used as a drainage route for the necrotic material of the fistula 3 which is easily aspirated with any cannula connected to any aspirator.

At this point the assistant surgeon keeps the sutures previously applied on the internal orifice 2 of the fistula 3 under tension by means of any forceps so as to form a kind of `` volcano '' (figure 9) whose `` crater '' € It is represented by the internal fistulous orifice 2 while the surgeon, having completely removed the fistuloscope 11, introduces a mechanical `` cut and sew '' stapler which can be semicircular or linear so that its branches include the base of the `` volcano '' € (figure 10). At this point the surgeon completes the cut and the mechanical suture of the internal fistulous orifice 2 (figure 11). The final result is simply a suture in the area where the internal fistulous orifice 2 was previously located (figure 12).

At the end of the operation, an adhesive material or even experimental materials based on stem cells can be inserted inside the fistulous path 3, now completely destroyed and cleaned, in order to compact and hermetically close the fistulous channel or to favor healing through cell regeneration. These materials can be inserted with any catheter that is no more than 2.5mm in diameter.

Advantages of the invention compared to traditional techniques The device according to the invention and the relative method, hereinafter defined as â € œMeinero procedureâ €, solves the problems of the traditional techniques mentioned above.

First of all, it guarantees the perfect and hermetic closure of the internal fistulous orifice 2 thanks to the use of the mechanical stapler. Since this is a key point for the occurrence of the relapse, it is evident that the hermetic closure determines a drastic reduction of the relapses.

As regards the problem of large and disfiguring scars of existing techniques, with the Meinero technique there are no surgical scars on the perianal or perineal skin as fistula 3 is treated from the inside (figure 13), with a significant improvement compared to what is shown in figure 3. The patient therefore does not need postoperative dressings and the return to work is almost immediate. Continuing in the resolution of the problems of the known technique, it can be stated that, with the Meinero technique, it is not possible to create false paths as the path of fistula 3 is always followed under vision: this condition can be compared to the action of entering a tunnel driving a car for which it is not possible to take the wrong road and, above all, sooner or later you will meet the exit which, in the case of fistula 3, is the internal anal orifice. It is therefore not possible to injure the anal sphincters as the fistula 3 is treated from the inside; not being able to create sphincter lesions, consequently there is also no risk of causing fecal incontinence.

Meinero's technique, having a diagnostic phase, makes preoperative diagnostic tests such as transanal ultrasound, fistulography and magnetic resonance unnecessary with evident savings of time and money. The technique, being performed in day surgery, with discharge therefore on the same day of admission and surgery, practically eliminates hospitalization time. The return to work takes place after 3-10 days with obvious advantages both for the worker but also for the employer.

Finally, the great advantage of this technique is that every gesture is done under direct vision, so as not to cause harm of any kind to the patient. Of course, a colostomy will never be made, even in the most severe cases. In a nutshell, it can be said that the complex classification of anal fistulas is missing which, based on the relationship that fistula 3 contracts with the sphincters and the spaces delimited by them, could have an interest in traditional surgical techniques: in fact, the intervention varied according to the type of fistula 3 found in the preoperative period. With Meinero's technique, it no longer matters whether fistula 3 crosses one or two sphincters, whether it is supra or transphhincter, as it is treated from the inside so that the relationships it contracts with the perianal structures lose their meaning.

The device for performing the Meinero technique includes:

∠’an elongated body or fistuloscope 11 according to the invention, advantageously with a handle and its own shutter that acts as a guide;

â ’fiber optic cable that crosses the elongated body

∠’electrode or other electrifiable device (connectable to mono or bipolar electrosurgical unit) that can be inserted in the elongated body of the fistuloscope 11; ∠’electrifiable endoscopic pliers that can be inserted into the elongated body of the fistuloscope 11;

∠’a mechanical scraper that can be inserted into the elongated body of the fistuloscope 11 to remove the necrotic tissue from the inside of the fistula 3; ∠’an anal retractor;

∠’a fenestrated anoscope with its introducer; ∠’a mechanical stapler;

∠’an adhesive material with catheters for its application inside the fistulous tract 3; ∠’various types of surgical threads;

∠’bags of saline solution.

The elongated body or Fistuloscope 11 is advantageously rigid, associated with an operating block (figure 14) or even semi-rigid or flexible. The important thing is that it has a smaller diameter that is between 2 and 5 mm and a length of the operating section of at least 16 cm. It is useful that there is a handle and that it is equipped with a shutter or in any case a guide that can be inserted in the operative channel of the fistuloscope 11. Its extremity is thus seen in the monitor representing a useful point of reference and orientation.

Fiber optic cable or other device

Each fiber optic device has its own cable (figure 14) for connection to a monitor display system. However, depending on the fistuloscope 11 being used, for example a lens system, the cable may be different.

Electrode or other electrifiable device

To destroy the fistula 3 from the inside, under vision, an electrode or other device which can be connected with a monopolar or even bipolar electrosurgical unit is passed through the operating channel of the fistuloscope 11. An example of an electrode is shown in figure 15. However, an electrified forceps for laparoscopy can also be used, as there are many on the market (figure 16) or other electrified devices as long as they have a diameter less than or equal to 2.5 mm and a length obviously greater than that of the operative portion of the fistuloscope 11 (at least 2 cm greater than it).

Endoscopic forceps that can be electrified

As already seen, the forceps can be used both with guiding functions and with the function of removing necrotic material and for cauterizing the internal wall of the fistula 3 when they are electrified (figure 16). Its branches can have a linear or even curved shape. For the length the same goes for the previous point.

Other devices to remove necrotic tissue from inside the fistula 3.

After cauterizing the granulation tissue inside the fistula 3, there remains a necrotic material that must be removed. For this purpose, it is possible to use any device which passes through the operating channel of the fistuloscope 11 and has the ability to remove necrotic tissue. Obviously it must exceed in length by at least two cm the operative section of the fistuloscope 11 and its diameter must be less than 2.5 mm. Its shape is preferable to either â € œcatch hookâ €, â € œspoonâ € or â € œbrushâ €, shapes that allow an excellent removal of necrotic tissue always under direct vision (figure 17).

Anal retractor

Various types of retractor can be used such as the Eisenhammer retractor (figure 18), Parks or others. The important thing is that they allow the vision of the light of the fistuloscope 11 or the end of the fistuloscope 11 itself when it reaches the internal fistulous orifice 2. The task of the retractor is therefore to allow, through its introduction, the vision of the anal canal and / or rectum.

They can be composed of two or more branches, they can be metal or plastic. In the latter case they are usually transparent or white and have a “gallery” shape (figure 18).

Fenestrated anoscope

To introduce the mechanical stapler, it is necessary to create space around the internal anal sphincter. A horseshoe anoscope is placed in the anus. Its dimensions must respect the anal caliber so it cannot exceed 3.5 cm and must be equipped with a conical introducer with a blunt tip to avoid traumas. The anoscope can also be equipped with holes on its external margin to allow its fixation to the perianal skin if necessary. An example can be the anoscope shown in figure 19.

Mechanical stapler

It is one of the fundamental elements of the technique. It guarantees the hermetic and definitive closure of the internal fistulous orifice 2 which we have seen to be the key point of every surgical treatment of the anal fistula 3. Advantageously, a semicircular stapler is used (figure 20) but other linear staplers or those equipped with special joints (roticulator) can also be used as long as they have the function of cutting and sewing hermetically. The final result will in any case be a suture with metal staples or resorbable material, depending on the suturing machine, in the anal canal or in the rectum 4 (figure 12). The important thing is that the branches of the stapler include the base of the â € œvolcanoâ € formed by the internal fistulous orifice 2 and the mucous membrane of the anal canal or rectum 4 in order to cut and hermetically close the orifice itself.

Adhesive materials and catheters for their application Once the operation is finished (once the internal orifice 2 has been closed and the necrotic material inside the fistula 3 has been removed), through the external orifice 1 of the fistula 3 a small catheter (which can have a diameter of 0.5 to 2.5 mm) is passed through the course of the fistula 3 until it reaches the internal fistulous orifice 2. The catheter is connected to a syringe containing glue material such as for example cyanoacrylate in a variable quantity from 0.5 to 1.5 ml and, while the catheter is slowly pulled outwards, the cyanoacrylate contained in the syringe is slowly inserted inside the fistulous path 3 so that this € ™ last is completely complete with glue material (figure 21). Alternatively, new stem cell-based materials may also be used.

Types of Surgical Threads and Saline Bags Any surgical thread can be used to perform the Meinero technique. Any surgical thread will be useful for fixing, for example, the fenestrated anoscope to the perianal skin as well as any surgical thread can be used to â € œinsulateâ € the internal fistulous orifice 2 and pull it to the point of â € œvolcanoâ €.

Saline bags are standard. In any case, generally, those of 5 liters are used but others of different quantities or types can also be used.

The above description of a specific embodiment is able to show the invention from a conceptual point of view so that others, using the prior art, will be able to modify and / or adapt this specific embodiment in various applications without further researches and without departing from the inventive concept, and, therefore, it is understood that such adaptations and modifications will be considered as equivalent to the exemplified embodiment. The means and materials for carrying out the various functions described may be of various nature without thereby departing from the scope of the invention. It is understood that the expressions or terminology used have a purely descriptive purpose and therefore not limitative.

Claims (10)

CLAIMS 1. A device for the surgical treatment of a complex perianal fistula, said fistula having an external cutaneous orifice (1), an internal intrarectal orifice (2) and a complex path (3) between said orifices (1,2), called device including: ∠’an operating block (10) that can be challenged by an operator; ∠’an elongated body (11) removably connected to said operating block (10) and having a blunt end (12) on the opposite side to said operating block (10); ∠'an optical element (13) for scanning provided at said blunt end (12), said optical element for scoping being connected, by means of optical fibers (14) which pass along said elongated body (11), to a connection point visual (15) on the operating block (10), ∠’an operating channel (16) present longitudinally in said elongated body, said operating channel having an inlet (17) on the side of said operating block and an outlet (18) in correspondence with said blunt end (12); â 'said elongated body (11) being such as to be introduced into said fistula by introducing said blunt end (12) into the external orifice (1), and then such as to follow the complex path (2) of the fistula, with the aid of the fluoroscopy by means of said optical element (13), until said blunt end (12) reaches said internal orifice (3) and flows into the rectum (4). 2. The device for the surgical treatment of a complex perianal fistula (3), as per claim 1, in which the elongated body (11) is substantially rigid so as to be able to internally pass through the perianal fistula (3) from its external orifice (1) cutaneous to its internal orifice (2) intrarectal, and substantially â € œrectilineizeâ € said fistula (3) between said two orifices (1,2). 3. The device for the surgical treatment of a complex perianal fistula (3), as per claim 1, in which said elongated body (11) is associated with a cauterization device, adapted to be introduced through said inlet (17 ) in said operative channel (16) up to said blunt end (12), protruding from said outlet mouth (18). 4. The device for the surgical treatment of a complex perianal fistula (3), as per claim 1, in which said elongated body (11) is associated with a mechanical removal device of cauterized tissue inside said fistula ( 3), adapted to be introduced through said inlet (17) into said operative channel (16) up to said blunt end (12), protruding from said outlet (18) and scraping the internal walls of said fistula (3 ). 5. The device for the surgical treatment of a complex perianal fistula (3), as per claim 1, in which said elongated body (11) is associated with a washing liquid injection device, suitable to be injected through said mouth inlet (17) into said operating channel (16) until it reaches said outlet mouth (18) and flows into said fistula (3). 6. The device for the surgical treatment of a complex perianal fistula (3), according to claim 1, in which said device is associated with a suturing machine adapted to close said internal orifice (2) by means of sutures. 7. The device for the surgical treatment of a complex perianal fistula (3), as per claim 6, in which, once the edges of said internal orifice (2) have been identified thanks to the exit of said blunt tip (12) in an intrarectal position , said suturing machine, introduced via the anus, is adapted to allow said edges to be raised until they assume a conical shape, and then to close on said conical shape by suturing said edges and resecting the terminal portion. 8. The device for the surgical treatment of a complex perianal fistula (3), as per claim 7, in which said suturing machine comprises two branches adapted to be closed on the edges of the orifice so as to cut and hermetically close the orifice same. 9. The device for the surgical treatment of a complex perianal fistula (3), as per claim 1, in which said elongated body (11) has said blunt end (12) with a diameter between 2 and 5 mm, in particular said elongated body (11) has a length greater than 16 cm. Use of the device according to any one of claims 1-9 for the surgical treatment of a complex perianal fistula (3).