WO2013088234A1

WO2013088234A1 - Upgraded medical device for performing ileostomies and/or jejunostomies

Info

Publication number: WO2013088234A1
Application number: PCT/IB2012/002716
Authority: WO
Inventors: Graziano Azzolini; Enrico Mariani; Emanuele PAGLIACCI
Original assignee: Evoluzione SRL
Current assignee: Evoluzione SRL
Priority date: 2011-12-16
Filing date: 2012-12-14
Publication date: 2013-06-20
Anticipated expiration: 2014-06-16
Also published as: EP2790767A1; ITMO20110326A1

Abstract

The medical device (1) for performing ileostomies and/or jejunostomies, comprises at least a tubular element (2) wherein is defined at least a first transit channel (3) having one or more first entry openings (3a) of the intestinal contents insertable inside the intestine (I) of a patient and, at least a first exit opening (3b) of the intestinal contents positionable outside the intestine (I), first obstruction means (5) of at least a first area (Ζ') of the intestine (I) placed along the tubular element (2), anchoring means (15) associated with the tubular element (2), insertable inside the intestine and suitable for cooperating with the patient's body to prevent the removal of at least the first obstruction means (5) with respect to the body itself and comprises second obstruction means (5') of at least a second area (Z") of the intestine (I) placed along the tubular element (2) and spaced from the first obstruction means (5), the second obstruction means (5') being insertable inside the intestine itself and being configured so as to prevent the transit of the intestinal contents through the second area (Z") of the intestine (I).

Description

UPGRADED MEDICAL DEVICE FOR PERFORMING ILEOSTOMIES AND/OR JEJUNOSTOMIES

Technical Field

The present invention relates to a medical device for performing ileostomies and/or jejunostomies.

Background Art

In the medical practice it is known that in case of intestinal illnesses such as Crohn's disease, ulcerative colitis, perforated diverticulitis, cancer, etc. .... meaning when it is no longer possible to evacuate feces naturally, the need may arise to perform a bowel resection with subsequent anastomosis, at which level must be excluded the transit of the intestinal contents which must therefore be diverted outwards.

For example, in case of intestinal cancer following which a surgical intestine resection has been performed with consequent anastomosis, the flow of the intestinal contents will have to be deviated to prevent them reaching the anastomosis area, infecting this and weakening the suture.

For this purpose, it is usual to perform an ileostomy, i.e., to connect the intestine to the outside by means of a stomy, i.e., a hole made on the abdominal wall. More in particular, the ileostomies can be of the temporary or permanent type depending on the illness.

As it is easy to appreciate, temporary ileostomies are used for the purpose of temporarily suspending, for a period of about three months, the intestinal continuity and the functions of a section of the intestine, after which intestinal continuity and the normal function of same are restored, while permanent ileostomies are used in the case of chronic illnesses and therefore envisage a permanent deviation of the intestine.

The present treatise refers mainly to the case of temporary ileostomies.

More in detail, temporary ileostomies are constructed by identifying a loop arranged upstream of the area to be safeguarded with respect to the direction of forward movement of the intestinal contents and sectioning the ileum at the level of the chosen loop. The extremity of the sectioned loop is made to pass through an opening made on the abdominal wall (stomy). To prevent the ileum loop retracting into the abdominal cavity this is pierced with a rod which blocks it outside the abdomen.

The ileum is thus split into two sections, one upper section communicating with the digestive apparatus and through which the contents coming from the digestive section are evacuated, and one lower section communicating with the operated area, the upper section of which is closed, thereby interrupting the intestinal continuity and the functions of the intestine.

When the healing process of this intestinal section has terminated, the two sections of the ileum are again opposed and anastomized, restoring intestinal continuity using a surgical technique.

This procedure for the realization of a temporary ileostomy has a number of drawbacks.

In fact, both the realization of the ileostomy and its removal require respective surgical operations performed in general anesthesia.

This obviously involves not only a high degree of discomfort, both physical and psychological, for the patient, but also long postoperative recovery times.

Furthermore, such procedure also involves high costs for the health service due to the very surgical operations which have to be performed to cure the illnesses affecting the intestine and which, as is known, require the use of specific equipment and qualified medical staff. Such costs inevitably tend to bear on the national health system.

Again, the medical staff and equipment used for such operations are obviously removed from the performance of other surgical operations, with a resulting extension of the waiting times of such operations.

The procedure for the realization of temporary ileostomies of the type described above is therefore expensive, in view of its complexity, both from an economic ■ and a health logistics viewpoint.

To overcome these drawbacks, a device has been devised having a tubular element with a plurality of openings for the entry of the intestinal contents, intended to be positioned inside the patient's intestine upstream of the operated area, and at least an intestinal contents exit opening, intended to be arranged outside the patient's body. This device of known type also comprises a first inflatable balloon for the obstruction of a section of the intestine and a second inflatable balloon suitable for cooperating with the patient's body to prevent the accidental removal of the device itself.

This medical device of known type also has a number of drawbacks however. In fact, the first balloon does not always allow an effective retention of the intestinal contents, which can therefore transit beyond the barrier defined by the first balloon itself and thus reach the area to be safeguarded.

Description of the Invention

The main aim of the present invention is to devise an upgraded medical device which permits to overcome the drawbacks of the medical devices of known type.

In particular, the present invention intends devising a device which allows considerably reducing the risk of the intestinal contents crossing the intestine and reaching the operated area.

Another object of the present invention is to devise an upgraded medical device for performing ileostomies and/or jejunostomies, that allows to overcome the mentioned drawbacks of the state of the art in the ambit of a simple, rational, easy and effective to use as well as low cost solution.

The above objects are achieved by the present medical device for performing ileostomies and/or jejunostomies, comprising:

- at least a tubular element wherein is defined at least a first transit channel having one or more first entry openings of the intestinal contents insertable inside the intestine of a patient and at least a first exit opening of the intestinal contents positionable outside the intestine;

- first obstruction means of at least a first area of the intestine placed along said tubular element, insertable inside the intestine itself and configured so as to prevent the transit of the intestinal contents through said first area of the intestine;

- anchoring means associated with said tubular element, insertable inside the intestine and suitable for cooperating with the patient's body to prevent the removal of said first obstruction means with respect to the body itself and characterized by the fact that it comprises second obstruction means of at least a second area of the intestine placed along said tubular element and spaced from said first obstruction means, said second obstruction means being insertable - inside the intestine itself and being configured so as to prevent the transit of the intestinal contents through said second area of the intestine.

Brief Description of the Drawings

Other characteristics and advantages of the present invention will become more evident from the description of a preferred, but not sole, embodiment of an upgraded medical device for performing ileostomies and/or jejunostomies, illustrated purely as an example but not limited to the annexed drawings in which:

Figure 1 is an axonometric view of a medical device according to the invention in a first embodiment with the obstruction means and anchoring means in narrow configuration;

Figure 2 is an axonometric view of the medical device of Figure 1 with the obstruction means and anchoring means in widened configuration;

Figure 3 is a transversal section of a medical device according to the invention in a second embodiment;

Figure 4 is a plan view of a medical device according to the invention in a third embodiment;

Figure 5 is an axonometric view of the stiffening means applied to a medical device according to the invention;

Figure 6 is an axonometric view of the medical device of Figure 1 partially fitted into a patient's intestine;

Figure 7 is an axonometric view of the medical device of Figure 2 completely fitted into a patient's intestine.

Embodiments of the Invention

With particular reference to such figures, globally indicated by reference number 1 is a medical device for performing ileostomies and/or jejunostomies, particularly of the temporary type.

The device 1 comprises at least one tubular element 2 wherein is defined at least a first transit channel 3 having one or more first entry openings 3a and at least one first exit opening 3b of the intestinal contents. The first entry openings 3a are insertable inside the intestine I of a patient and the first exit opening 3b is positionable outside the intestine I.

The tubular element 2 is made of an opaque radium material, e.g., silicone or polyurethane.

The first entry openings 3 a and the first exit opening 3 b are suitably arranged on opposite sides of the tubular element 2. More in particular, the tubular element 2 comprises at least a first section 2a on which are obtained the first entry openings 3 a and at least a second section 2b on which is obtained the first exit opening 3b.

The first section 2a is insertable inside the intestine I of the patient, and in particular the ileum, through a stomy obtained on the patient's abdomen A, e.g., to perform an operation in laparoscopy such as a surgical operation consisting of the resection of a section of the ileum or relating to the caecum.

The first entry openings 3a are defined in correspondence to the side surface of the first section 2a.

Preferably, at least a part of the first entry openings 3 a is arranged along the longitudinal extension of the first section 2a.

Advantageously, the first entry openings 3 a are distributed in such a way as to allow the drainage along the substantial totality of the side surface of the first section 2a. More in particular, the first entry openings 3a are longitudinally staggered the one to the other and are arranged along a theoretical spiral which envelops the first section 2a.

Suitably, the first entry openings 3a have a substantially elliptic shape. More in detail, the larger axis of the first entry openings 3 a is arranged substantially parallel to the longitudinal extension of the first section 2a.

The first entry openings 3 a are big enough to allow the efflux of the intestinal contents inside the first transit channel 3 and, at the same time, avoid the weakening of the tubular element 2. The elliptic shape of the first entry openings 3 a does in fact permit the greatest possible efflux, the weakening of the first section 2a being equal.

In this respect, i.e., to allow the presence of an adequate number of first entry openings 3a having the above-mentioned dimensions, the length of the first section 2a is substantially between 5 cm and 10 cm.

The axial extremity of the first section 2a is suitably reinforced, e.g., by means of a spiral tip or the like, to make it easier to insert inside the intestine I.

In an alternative embodiment not shown in the illustrations, the tubular element 2 has just one first entry opening 3a defined in correspondence to its axial extremity opposite the first exit opening 3b.

The second section 2b is instead meant to be arranged outside the intestine I and the first exit opening 3b, arranged in correspondence to its axial extremity, is associable with a container for collecting the intestinal contents not shown in the illustrations. The second section 2b has a length between 10 cm and 20 cm, preferably equal to 15 cm.

The device 1 then comprises first obstruction means 5 of at least a first area Z' of the intestine I associated with the tubular element 2, insertable inside the intestine itself and configured so as to prevent the transit of the intestinal contents through such first area Z' .

Advantageously, the first obstruction means 5 are associated integral with the tubular element 2. More in detail, the first obstruction means 5 are defined integral with the tubular element 2.

The first obstruction means 5 are suitable for isolating the part of the intestine I arranged downstream of the first area Z' with respect to the forward-movement direction of the intestinal contents to prevent the latter arriving in correspondence to the operated area.

Preferably, the first obstruction means 5 are suitable for being arranged along a section of the ileum.

The first obstruction means 5 are therefore suitable for separating the intestine I into two parts, one first part Γ and one second part I". The first and the second parts Γ and I" are arranged upstream and downstream respectively of the first obstruction means 5 with respect to the forward-movement direction of the intestinal contents.

The first part P is therefore in communication with the patient's stomach, while the second part I" corresponds to the part, the functions of which have to be suspended inasmuch as it comprises the portion to be safeguarded, e.g., the portion in which an anastomosis has been performed.

The first entry openings 3a, and therefore also the relative first section 2a, are meant to be housed in the first part Γ of the intestine I, i.e., upstream of the first obstruction means 5 with respect to the forward-movement direction of the intestinal contents, so as to intercept the feces arriving from the digestive system.

The first obstruction means 5 are configured in such a way as to prevent the transit of the intestinal contents coming from the first part Γ into the second part I".

In the embodiment shown in the illustrations, the first section 2a of the tubular element 2 is placed between the first obstruction means 5 and the axial extremity opposite the first exit opening 3b.

The first obstruction means 5 are therefore placed between the first section 2a and the second section 2b.

In an alternative embodiment, not shown in the illustrations, the first obstruction means 5 are arranged in correspondence to the axial extremity of the tubular element 2 opposite the first exit opening 3b.

According to the invention, the device 1 also comprises second obstruction means 5' of at least a second area Z" of the intestine I associated with the tubular element 2 arid spaced from the first obstruction means 5. The second obstruction means 5' are also insertable inside the intestine I and are configured so as to prevent the transit of the intestinal contents through the second area Z".

The second obstruction means 5' are also placed between the first entry openings 3a and the first exit opening 3b.

More in particular, the second obstruction means 5' are placed between the first obstruction means 5 and the first exit opening 3b.

The second obstruction means 5' are therefore arranged in series with respect to the first obstruction means 5 along the tubular element 2 and are suitable for defining a further barrier against the transit of the intestinal contents, so as to prevent any parts of the latter which have leaked between the first obstruction means 5 and the intestinal wall of the first area Z' from arriving in correspondence to the area of the intestine itself to be safeguarded. The second obstruction means 5' are therefore arranged downstream of the first obstruction means 5 in the direction of forward movement of the intestinal contents.

The tubular element 2, besides the first and the second sections 2a, 2b mentioned above, also therefore has a third section 2c placed between the first and the second obstruction means 5, 5'.

The length of the third section 2c is between 3 cm and 8 cm, preferably equal to 3-4 cm.

Suitably, along the third section 2c are defined one or more second entry openings 16 suitable for draining inside a second transit channel 3' any parts of the intestinal contents which have leaked through the first obstruction means 5 and have therefore entered the second part Γ ' of the intestine I.

More in particular, the second transit channel 3' has at least a second exit opening 3b' arranged on the opposite side of the second entry openings 16. The second transit channel 3' is also defined inside the tubular element 2.

The second transit channel 3' can coincide with the first transit channel 3, in which case the second exit opening 3b' coincides with the first exit opening 3b, as shown in the embodiment of figures 1 and 2.

Alternatively, the second transit channel 3' is distinct from the first transit channel 3, in which case the second exit opening 3b' is distinct from the first exit opening 3b, as shown in the embodiment of the figures 3 and 4.

The transit channels 3, 3' generally have a gauge of not more than 24 French, preferably equal to about 20 French.

Advantageously, the first and the second obstruction means 5, 5' are mobile between a relative narrow configuration to allow their insertion into the intestine I through the stomy, and a widened configuration, wherein they obstruct the first and the second areas Z', Z" of the intestine I respectively to prevent the transit of the intestinal contents from the first part Γ towards the second part I".

In the preferred embodiment shown in the illustrations, both the first and the second obstruction means 5 and 5' are composed of an inflatable balloon. Such inflatable balloons 5, 5' are arranged outside the tubular element 2 and are substantially deflated in the narrow configuration and inflated in the widened configuration. The balloons 5, 5' generally have a volume of less than or the same as 10 cm , preferably equal to about 5 cm .

Advantageously, the device 1 comprises stiffening means 17, shown in figure 5, associated with the obstruction means 5 and 5' and suitable for avoiding the collapse of the section 2c placed between them during use.

More in detail, the stiffening means 17 comprise a plurality of stiffening elements 17a of the rigid type and having a substantially filiform shape, which are at least placed between the balloons 5 and 5'. The stiffening elements 17a are spaced from one another to define a plurality of gaps 18 between them. The gaps 18 are suitable for allowing the transit of the intestinal contents which have leaked through the first obstruction means 5. The stiffening elements 17a in practice define a sort of cage arranged around the third section 2c and suitable for maintaining the reciprocal distance between the balloons 5 and 5' fixed and constant during the use of the device 1. The presence of the stiffening means 17 is advantageous both in the case of the device 1 having the second entry openings 16 and in the case of the latter being absent.

More in particular, the device 1 comprises starting means 6,6' of the balloons 5 and 5'. In the embodiment shown in the figure 5, the filiform elements 17a extend starting from the extremity of the first section 2a, so as to keep a fixed distance between such extremity and the second obstruction means 5'.

The starting means 6,6' comprise at least an inflation/deflation channel, distinct from the transit channels 3, 3' and having at least a gap 7,7' for the air to flow in and out.

In a first embodiment, of the type shown in the figures 1 and 2, the starting means 6,6' are single for both the obstruction means 5 and 5' and therefore comprise a single inflation/deflation channel communicating with both the balloons and having a gap 7,7' for the air to flow in and out.

In a second embodiment, shown in figure 4, the starting means 6,6' comprise first starting means 6 of the first obstruction means 5 and second starting means 6' of the second obstruction means 5', where the first and the second starting means 6 and 6' are distinct from one another. In this second embodiment, therefore, the starting means 6 and 6' comprise a respective inflation/deflation channel having a relative gap 7, 7' for the air to flow in and out.

The starting means 6,6' also comprise a check valve, not visible in detail in the illustrations, suitable for preventing the accidental escape of the air contained in the balloons 5, 5' and controllable by an operator to allow the air to flow out towards the outside.

Advantageously, the device 1 also comprises a number of anchoring means 15 associated with the tubular element 2, insertable inside the intestine I and suitable for cooperating with the patient's body to prevent the removal of at least the obstruction means 5, 5' from the intestine \r

The anchoring means 15 are associated integral with the tubular element 2. More in particular, the anchoring means 15 are defined integral with the tubular element 2.

The anchoring means 15 are also placed between the first and the second section 2a and 2b and, more in particular, between the first obstruction means 5 and the exit openings 3b, 3b'.

Because the device 1 is meant to be used in particular in the case of operations involving the caecum, after the insertion of the device 1 inside the intestine I, the first obstruction means 5 take up a position along a section of the ileum, obstructing it, while the anchoring means 15 position along the caecum, contacting its inner wall.

During use, the anchoring means 15 are arranged downstream of the first obstruction means 5 with respect to the direction of forward movement of the intestinal contents and are therefore meant to be arranged along the second part I" of the intestine I. More in particular, during use the anchoring means 15 are also arranged downstream of the second obstruction means 5' with respect to the direction of forward movement of the intestinal contents. The second obstruction means 5' are therefore placed between the first obstruction means 5 and the anchoring means 15.

The tubular element 2 then has a fourth section 2d placed between the second obstruction means 5' and the anchoring means 15. The length of the fourth section 2d is between 15 cm and 25 cm, preferably equal to 20 cm. Preferably, the fourth section 2d is integral, i.e., it does not have any opening defined on it.

Nevertheless, embodiments cannot be ruled out alternative to those shown in the illustrations and wherein along the fourth section 2d are defined one or more entry mouths suitable for draining inside one of the transit channels 3, 3' any parts of the intestinal contents which have leaked through the second obstruction means 5'.

The anchoring means 15 are also mobile between a relative narrow configuration, to allow the insertion inside the intestine I, and a relative widened configuration, wherein they are suitable for contacting the inner wall of the intestine I to prevent the removal of the obstruction means 5, 5'.

Suitably, the movement of the anchoring means 15 from the narrow configuration to the widened configuration or vice versa is separate from the movement of the obstruction means 5, 5'.

The user can therefore activate/deactivate the obstruction means 5, 5' and the anchoring means 15 according to the sequence he/she prefers.

In the preferred embodiment shown in the illustrations, the anchoring means 15 are also of the inflatable balloon type. The volume of the balloon 15 is for example between 10 and 15 cm³.

The device 1 then comprises activation means 6" of the anchoring means 15 distinct from the starting means 6, 6'.

More in particular, the activation means 6" comprise an inflation/deflation channel defined in the tubular element 2, communicating with the balloon 15 and having a gap 7" for the air to flow in and out. Suitably, the inflation/deflation channel which puts into communication the gap 7" and the balloon 15 is distinct both from the channel communicating with the balloons 5 and 5' (or from the channels communicating with the balloons 5 and 5' depending on whether the starting means 6 and 6' are coinciding or distinct from one another) and from the transit channels 3, 3'.

The activation means 6" also comprise a check valve, not visible in detail in the illustrations, suitable for preventing the accidental escape of the air contained in the balloon 15 and controllable by an operator to allow the air to flow out towards the outside and therefore move the balloon itself from the widened configuration towards the narrow configuration.

The device 1 then comprises external retention means 8 associated with the second section 2b and suitable for cooperating with the patient's body, e.g., with his/her abdomen A, to block the position of the obstruction means 5, 5' with respect to the body itself.

The retention means 8 are also suitable for cooperating with the anchoring means 15 to block the position of the obstruction means 5, 5' inside the intestine I. The retention means 8 are therefore suitable for applying a counter-pressure on the anchoring means 15.

The retention means 8 comprise at least one retention element, perforated and fitted sliding over the second section 2b. The retention element 8 defines a contact surface meant to rest against the patient's body.

In the embodiment shown in figure 4, the retention element 8 is of the type of a disc having a central through hole through which to fit the second section 2b. Preferably, the retention element 8 is made of a material with high friction coefficient, e.g., silicone, in such a way as to make its sliding difficult with respect to the tubular element 2.

During use therefore, the retention element 8 is made to slide on the second section 2b until its contact surface is resting against the patient's abdominal wall A.

Different embodiments of the retention element 8 cannot however be ruled out, not shown on the attached illustrations and having, e.g., guide means of the second section 2b. Such guide means are, e.g., made up of a housing seat for a portion of the second section 2b, which extends along a substantially inclined direction with respect to the axis of the through hole, the latter not visible in detail in the illustrations. More in particular, the housing seat extends along a direction substantially parallel to the contact surface of the retention element 8. In a further embodiment, the retention element 8 can also comprise fixing means 1 1, e.g., composed of one or more through holes, associable with the patient's body, e.g.* by means of suture.

The operation of the present invention is the following. A stomy is considered to have already been made on the patient's abdomen A, e.g., to perform an operation in laparoscopy on the patient's intestine, or specifically to perform the ileostomy and/or the jejunostomy.

At the end of the surgical operation affecting the intestine, the tubular element 2 is made to pass through the above stomy in such a way as to insert its first section 2a inside the intestine I, and in particular inside the ileum, in correspondence to the first area Z' placed upstream of the operated part with respect to the direction of forward movement of the intestinal contents.

The tubular element 2 is pushed inside the intestine I in such a way that the first entry openings 3a are oriented towards the patient's stomach.

The first obstruction means 5 are also introduced inside the intestine I.

Obviously, during the insertion of the tubular element 2 inside the intestine I the balloon 5 is in narrow configuration so as to make its transit through the stomy easier.

The tubular element 2 is further pushed inside the intestine I in such a way as to also gradually bring the second obstruction means 5' and the anchoring means 15 inside it.

The device 1 must be inserted inside the intestine in such a way that the second obstruction means 5' also find themselves upstream of the operated area during use.

During the insertion phase of the device 1 the second obstruction means 5' and the anchoring means 15 are arranged in narrow configuration, in such a way as to easily transit through the stomy made on the patient's abdomen A.

Once the tubular element 2 has been inserted in the way just described and once the above surgical operation has ended, the part of the intestine affected by the operation itself is isolated.

More in particular, the balloons 5 and 5' are moved to their respective widened configurations by blowing air through the gap 7,7'. This way, the balloons 5 and 5' inflate and, by widening, occupy the entire section of the areas Z' and Z" in which they are inserted, obstructing them.

As described above, the inflation of the balloons 5 and 5' can occur at the same time or separately the one from the other depending on whether they have a single inflation/deflation channel for both balloons or two distinct channels respectively.

The balloons 5 and 5' are deformable and when they are in widened configuration, they therefore adapt to the inner walls of the intestine I.

In the same way, the balloon 15 is brought to its widened configuration by blowing air through the gap 7". This way the balloon 15 inflates so as to define a cross section bigger than that of the stomy.

By then applying a traction force on the second section 2b remaining outside the intestine I and which protrudes from the patient's body, the balloon 15 is moved towards the patient's abdominal wall A.

At this point, the retention element 8 is moved in correspondence to the patient's body, outside this, making it slide along the second section 2b and moving its contact surface so as to rest against the patient's skin.

This way, the tubular element 2 is blocked with respect to the patient's body because the retention element 8 and the balloon 15 are arranged on opposite sides of the stomy.

The intestinal contents which come from the patient's stomach and cross the first part Γ of the intestine I are then intercepted by the balloon 5, which prevents them from moving forward in the second part I", and, consequently, from entering the first transit channel 3 through the first entry openings 3 a defined along the first section 2a and arranged in such a way as to substantially cover all its side wall. In the event of a part of the intestinal contents managing to transit through the balloon 5, its transit inside the second part I" is obstructed by the second balloon 5' in such a way as to convey it inside the second transit channel 3' through the second entry openings 16 defined along the third section 2 c. In the very rare event of a part of the intestinal contents also transiting through the balloon 5' this part can in any case enter the first transit channel 3 through any entry mouths defined along the fourth section 2d.

The intestinal contents then cross the transit channels 3, 3' until they reach the exit openings 3b, 3b' through which they are conveyed into the specific collection container.

To remove the ileostomy and/or the jejunostomy, the balloons 5, 5' and 15 merely have to be deflated by means of the respective valves positioned in the proximity of the gaps 7, 7' and 7" and the tubular element 2 taken out through the stomy.

Once the tubular element 2 has been removed, the intestine I is again without impediments and can return to its normal operation, so the intestinal contents cross the now free areas Z' and Z" and move along the second part I" of the intestine itself.

The stomy made on the patient's abdomen A is then suitably medicated and protected until it is completely well again and healed up.

The present invention therefore relates to a medical device 1 comprising: a tubular element 2 wherein is defined a first transit channel 3 having one or more first entry openings 3 a and at least a first exit opening 3b, and comprising at least a first and a second inflatable balloon 5, 5', used to make ileostomies in the treatment of intestinal illnesses, and at least a third inflatable balloon 15 suitable for preventing the removal of the balloons 5 and 5' towards the outside of the intestine I.

It has in fact been ascertained how the described invention achieves the proposed objects and in particular, the fact is underlined that the medical device for making ileostomies according to the invention permits considerably reducing the risk of the intestinal contents reaching the operated area compared to the devices of known type.

The presence of two means for obstructing the intestine arranged in series the one to the other does in fact permit successfully protecting the operated area.

Claims

1) Medical device (1) for performing ileostomies and/or jejunostomies, characterized by the fact that it comprises:

- at least a tubular element (2) wherein is defined at least a first transit channel (3) having one or more first entry openings (3 a) of the intestinal contents insertable inside the intestine (I) of a patient and at least a first exit opening (3b) of the intestinal contents positionable outside the intestine (I);

- first obstruction means (5) of at least a first area (Ζ') of the intestine (I) placed along said tubular element (2), insertable inside the intestine itself and configured so as to prevent the transit of the intestinal contents through said first area (Ζ') of the intestine (I);

- anchoring means (15) associated with said tubular element (2), insertable inside the intestine and suitable for cooperating with the patient's body to prevent the removal of at least said first obstruction means (5) with respect to the body itself and

characterized by the fact that it comprises second obstruction means (5') of at least a second area (Z") of the intestine (I) placed along said tubular element (2) and spaced from said first obstruction means (5), said second obstruction means (5') being insertable inside the intestine itself and being configured so as to prevent the transit of the intestinal contents through said second area (Z") of the intestine (I).

2) Device (1) according to claim 1, characterized by the fact that said obstruction means (5, 5') and said anchoring means (15) are placed between said first entry openings (3a) and said first exit opening (3b).

3) Device (1) according to claim 1 or 2, characterized by the fact that said second obstruction means (5') are placed between said anchoring means (15) and said first obstruction means (5).

4) Device (1) according to any of the preceding claims, characterized by the fact that said tubular element (2) comprises at least a first section (2a) on which are defined said first entry openings (3a), at least a second section (2b) on which is defined said first exit opening (3b), said obstruction means (5, 5') and said anchoring means (15) being placed between said first and second section (2a, 2b), at least a third section (2c) placed between said first obstruction means (5) and said second obstruction means (5') and at least a fourth section (2d) placed between said second obstruction means (5') and said anchoring means (15).

5) Device (1) according to claim 4, characterized by the fact that said third section (2c) has a length between 3 cm and 4 cm.

6) Device (1) according to claim 4 or 5, characterized by the fact that said fourth section (2d) has a length between 18 cm and 20 cm.

7) Device (1) according to one or more of the claims from 4 to 6, characterized by the fact that said tubular element (2) comprises one or more second entry openings (16) defined along said third section (2c) and communicating with a second transit channel (3') having at least a second exit opening (3b').

8) Device (1) according to claim 7, characterized by the fact that said second transit channel (3') coincides with said first transit channel (3), said second exit opening (3b⁵) coinciding with said first exit opening (3b).

9) Device (1) according to claim 7, characterized by the fact that said second transit channel (3') is distinct from said first transit channel (3), said second exit opening (3b') being distinct from said first exit opening (3b).

10) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises stiffening means (17) associated with said tubular element (2) and placed at least between said first and second obstruction means (5, 5').

11) Device (1) according to claim 10, characterized by the fact that said stiffening means (17) comprise a plurality of stiffening elements (17a) of the rigid type and having a filiform shape.

12) Device (1) according to claim 11, characterized by the fact that said stiffening elements (17a) are spaced from one another to define a plurality of through gaps (18).

13) Device (1) according to claim 10 or 11, characterized by the fact that said filiform elements (17a) extend starting from the free extremity of said first section (2a), so as to keep a fixed distance between such extremity and said second obstruction means (5').

14) Device (1) according to one or more of the claims from 4 to 13, characterized by the fact that said tubular element (2) comprises at least an entry mouth defined along said fourth section (2d).

15) Device (1) according to one or more of the preceding claims, characterized by the fact that said obstruction means (5, 5') and said anchoring means (15) are mobile between a relative narrow configuration and a relative widened configuration.

16) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises starting means (6, 6') of said first and second obstruction means (5, 5') and activation means (6") of said anchoring means (15) distinct from said starting means (6, 6').

17) Device (1) according to one or more of the preceding claims, characterized by the fact that said starting means (6, 6') are single for said first and second obstruction means (5, 5').

18) Device (1) according to one or more of the claims from 1 to 16, characterized by the fact that said starting means (6, 6') comprise first starting means (6) of said first obstruction means (5) and second starting means (6') of said second obstruction means (5'), said first and second starting means (6, 6') being distinct from one another.

19) Device (1) according to one or more of the preceding claims, characterized by the fact that said obstruction means (5, 5') and said anchoring means (15) are of the inflatable balloon type, said starting means (6, 6') and said activation means (6") comprising respective inflation/deflation channels distinct from said transit channel (3) and having a relative gap that faces to the outside for the air to flow in and out.