WO2013027182A1 - Capsule for local therapy by means of an endoluminal plaster in the gastrointestinal system - Google Patents

Abstract

The present invention refers to the field of local therapies in the gas trointestinal system. In particular, it refers to a swallowable capsule for local therapy at a target site, said capsule comprising a capsule body with a longitudinal axis and equipped with image sensor means, said capsule further comprising a driving and orienting wireless system adapted to interact with an external unit for receiving information and the driving of said capsule, wherein said capsule comprises a compartment formed in said capsule body, said compartment housing a polymeric film means, said capsule also comprising supporting and releasing means for moving said polymeric film means according to a direction of application perpendicular to said longitudinal axis, from a retracted position where said polymeric film means are contained inside said compartment, to an extracted position where said polymeric film means is projected from said compartment to make contact with said target.

Description

CAPSULE FOR LOCAL THERAPY BY MEANS OF AN ENDOLUMINAL PLASTER IN THE GASTROINTESTINAL SYSTEM

DESCRIPTION

The present invention refers to the field of local therapies in the gastrointestinal system and in particular it refers to a swallowable capsule magnetically guided with a device for releasing polymeric films for therapeutic use.

Numerous pathologies of the gastrointestinal tract manifest themselves with more or less localised chronic inflammations, ulcers and bleeding. A few examples of such pathologies are Crohn's disease or granulomatous regional enteritis, coeliac disease and ulcerative colitis that manifest by lesions typical of inflammation or phlogosis and of chronic inflammation, i.e. formation of granulation tissue and granulomas, abscesses, ulcers, adhesions or fibromas.

The symptoms of these pathologies occur along the entire alimentary canal and in different forms. In the case of Crohn's disease, the disease mainly presents itself in the distal ileum and in the colon (in 40-55% of cases), frequently in the rectum and in the perianal region (in 30-36% of cases) and in some cases also between the mouth and the duodenum (with percentages of 0.6%-0.9%); the incidence on the oesophagus, stomach and duodenum has smaller percentages.

A first problem encountered in this type of condition is the presence of alterations of the mucosa of the gastrointestinal tract of different type and severity; an alteration that commonly occurs is segmentation (so-called "skip lesions").

Excluding the treatment of complications or cases in which the damaged tissues are identified and are located within areas that can be surgically removed without altering the overall functions of the digestive apparatus, currently these pathologies are cured with medicines administered systemically and not topically (like, for example, anti-inflammatories, immunosuppressants, antibiotics, biological therapies). Such a method of administration is the main cause for the poor effectiveness of existing pharmacological therapies, since the amount of drug that reaches the area suffering from the pathology and the action time of the d rug on the tissue are generally insufficient.

The difficulty of releasing drugs locally in suitable doses exclusively at the affected tissues is therefore a problem linked to this type of disease.

Current diagnostic systems consist of endoscopes and colonoscopes, which allow the intestinal tract to be viewed from the rectum up to the caecum. It is known how endoscopy is a now standard procedure in clinical practice throughout the world and it is used daily in practically all hospitals and clinics.

Due to mechanical limitations of these instruments and because of human anatomy, however, certain tracts of the intestine cannot be viewed, like for example the small intestine, where the first effects of Crohn's disease frequently occur. In order to avoid this problem, alternative diagnostic systems consist of swallowable endoscopic capsules, currently widely used and accepted for clinical practice. They allow images of the entire gastrointestinal tract to be recorded with different effectiveness depending on the tract being looked at.

These capsules have some limitations, since they are completely passive, they cannot be stopped, controlled and/or directed by the operator to observe areas of interest in wh ich there are, for example, blotches or bleeding. Moreover, after inspection, medical therapy must be undertaken, which has the problems described earlier.

In order to at least partially solve the aforementioned problems, active diagnostic capsules have been developed, i.e. which are capable of active movement and/or guided inside the gastrointestinal lumen (for example coil-type capsules, capsules with legs, with magnetic movement etc).

There are also capsules of this type that are used to release suture clips (an example of a robotic capsule for releasing a surgical clip is described in EP2163206) or drugs. In this last case the drug is released in the lumen mainly in liquid or solid form. US 7,763,014 describes a swallowable capsule that, following a natural movement due to the physiological transit inside the lumen, reaches the desired intestinal tract, where it releases pharmaceutical substances in liquid or powder form. The release occurs through an expulsion mechanism consisting of a piston capable of expelling the drug contained in a chamber formed inside the capsule. Such a type of release, although more targeted, cannot however be classified as a topical therapy, but instead it has the problems described earlier for systemic types of administration. Yet another example of capsules for transporting and releasing substances such as drugs, etc. in the gastrointestinal tract is described in WO 2010/022716.

Also known are swallowable capsules, suitable for example for acquiring images and information during exploration of the gastrointestinal tract, therefore equipped with image acquisition means and sensors; an example of such a capsule is described in US 5,395,366.

Purpose of the present invention is therefore to provide a capsule that solves the problems described above and allows local (topical) therapy in the gastrointestinal system.

Such purposes are accomplished by a capsule for local therapy through an endoluminal plaster in the gastrointestinal system the essential characteristics of which are defined in the first of the attached claims.

The characteristics and advantages of the capsule according to the present invention will become clearer from the following description of embodiments thereof, given as non-limiting examples, with reference to the attached drawings, in which: figure 1 shows a perspective view of a swallowable capsule for local therapy according to the present invention;

figure 2 shows the capsule of figure 1 , in which it is possible to clearly see a compartment, made inside the capsule itself, in which a plate is housed to support polymeric film means;

figure 3a is a view of the capsule of the previous figures in which, inside the housing compartment, the polymeric film means supported by the plate of figure 2 are visible;

figure 3b shows the capsule of the previous figures without the front and rear caps to highlight the magnets and image sensor means contained inside the caps themselves;

figures 4a and 4b represent the movement of the plate between two positions, a retracted position A, completely housed inside the compartment, and an extracted position B, outside the compartment, respectively;

figures from 5a to 5c illustrate an opening sequence of the housing compartment following the opening of doors; figure 6 shows shape memory means that actuate a leverage for the movement of the polymeric film means, with doors in open position;

figures 7a and 7b represent, in greater detail, a system for blocking/unblocking a plate that supports the polymeric film means;

figure 8 is a perspective view of the capsule of the previous figures in which it is possible to see the system for moving the plate, whereas the other components have not been illustrated for the sake of greater clarity of representation;

figure 9 is a further view of the system for moving the plate, and in particular of thrust springs for lifting the plate;

figure 10 represents a detailed view of the plate mounted on the body of the capsule and, in particular, of the blocking/unblocking system that frees the lifting of the plate;

figure 1 1 is a perspective view from below that shows, in greater detail, the leverage for moving the plate; and

figure 12 is a functional schematisation of the leverage of the previous figures.

In the following description, by the word "capsule" we mean substantially a cylindrical container, with rounded ends, of comparable size to that of a pill, so as to be able to be swallowed.

With reference to figure 1 , the endoscopic capsule according to the invention comprises a capsule body 1 , with longitudinal development according to an axis X and in particular substantially cylindrical in shape, closed at the two ends 1 a and 1 b, called front and rear, by respective caps 2 and 3 the front cap 2 is at least partially transparent since it houses image sensor means and relative lighting means inside it, generically indicated with 4 and schematically illustrated in figure 3b, where the capsule is represented without the caps.

Inside the caps 2 and 3, again as shown in figure 3b, driving means are also housed, such as, according to the described embodiment, but not for limiting purposes, a pair of magnets 5. Such a pair of magnets makes up a wireless driving and orienting system of the capsule adapted to interact with a magnetic field (not shown) external to the body of the patient that is generated by an external command unit managed by expert medical personnel, so as to be able to command the capsule. In particular, the capsule is directed so that the image sensor means 4 face towards the gastrointestinal tract to be analysed.

The publication "Miniaturized robotic devices for endoluminal diagnosis and surgery: a single-module and a multiple-module approach", by A. Menciassi, et al., 31 st Annual I nternational Conference of the I EEE EMBS Minneapolis, Minnesota, USA, September 2-6, 2009, describes an example of driving able to be applied to the capsule according to the present invention. Such driving is carried out through the interaction between at least one permanent magnet, housed on-board the capsule, and an external driving unit, comprising a robotic arm that moves an external magnet; the latter generates a magnetic field whose variation in space, by acting on the magnet onboard the capsule, causes the capsule itself to move.

Now going back to what is per se subject of the present invention, on the outer surface of the capsule one or more grooves or throats 6 are made, according to the longitudinal axis X, these grooves or throats being suitable, as will be made clearer hereafter, for removing the mucus present on the intestinal wall.

The capsule body 1 is equipped with doors 7 that can be opened, in the manner that will be described shortly, to expose a housing compartment 8 inside the body itself. The doors 7, once closed, define a portion of outer surface of the capsule. Therefore, the grooves can also be made on the doors themselves, without interruptions (figure 1 ).

As shown in figures 5a, 5b, 5c, during opening, the doors are expelled laterally, i.e. they open with a rotary movement to wrap around the capsule; the opening movement is stabilised and ensured to be correct by pivots 7a that project from the doors according to the axis X to engage in respective and suitable guides 70 (see in particular figures 2 and 8) made on the body and in particular on the walls 2a, 3a, which laterally define the compartment 8 and that, at the same time, constitute the walls that divide the compartment from the caps. The guides 70 have a particular curvature that forces the pivot, and therefore the door, in an opening movement to rotate and at the same time move away from the outer surface of the capsule body. The doors 7 also have respective seats 71 , specular with respect to the axis X, for housing a cylindrical head 150 of a rod 15 that sets each of the doors in rotation, as will become clearer hereafter. The rods 15 are therefore four in number and connected in pairs, by transmission shafts 153, arranged along the axis X, and necessary to simultaneously move the rods (figure 8).

Inside the compartment 8 a support plate 9 is housed, arranged parallel to said longitudinal axis X and having an upper surface 9a facing towards the outside of the compartment and of the capsule, in general, and a surface opposite it, thus lower 9b (figure 7a, 7b).

As shown in figures 4a and 4b, the plate 9 is moveable, along a direction of application Y of the film, perpendicular to said longitudinal axis X, between a retracted position A, completely inside the compartment 8 and an extracted position B, in which the plate is raised outside of the capsule body. Such a movement from the retracted position to the extracted position corresponds to the simultaneous opening of the doors

7. The plate 9 is engaged on two support pivots 10 that ensure the correct sliding along the direction of application Y.

The plate 9 is kept in retracted position by a trigger 1 1 that, engaging with a protrusion 90 that extends from the plate itself, forces the plate into position; the trigger and its hooking on the plate is shown in greater detail in figures 7a, 7b. The trigger 1 1 is fixedly connected to the capsule body 1 and it is also housed inside the compartment

8. The trigger 1 1 is actuated by a leverage wholly indicated with 12 moved by shape memory means (figure 6), consisting of a shape memory wire 13. In particular, figure 10 shows the wire 13 in which a fixed end 13a of the wire 13 engages fixedly connected to the capsule body 1 and is connected, as will be described more clearly hereafter, to an electrical power source (not shown), whereas the other free end 13b engages with a control pulley 12a. Between the two ends 13a, 13b the wire 13 also winds on a further idle pulley 12b opposite the control pulley and arranged aligned with the latter along the axis X. From the control pulley 12a a control pivot 12c rises, centrally and in direction Y, housed inside the capsule body and, specifically, inside the rear cap 3.

In the control pivot 12c, at the end of the pivot opposite the one fixedly connected to the control pulley 12a, a ring 12d is inserted (figure 8) to the periphery of which (thus in decentred position) a first end 120e of a lever arm 12e is fixed. The lever arm 12e is arranged perpendicular to th e control pivot 12c, and extends between the aforementioned ring 12d and the central body 120f of a control spring 12f, to which it is fixedly connected through a second end 121 e. The control spring 12f comprises the central body 120f on which an oval-shaped slotted seat 122f is made that engages on a first of the two support pivots 10 that force the plate to move in just direction Y. As shown in figure 9, on the body 120f of the spring some seats 123f are made (specular with respect to the first support pivot according to the longitudinal axis X and opposite to the end 121 e in direction Y) suitable for housing a head 120g of a second arm 12g (figure 10) of the leverage 12.

The second arm 12g is thus connected to the trigger 1 1 through a system of levers that defines, together with the second arm and with the trigger themselves, an articulated quadrilateral leverage.

As shown in the figures and in greater detail in figure 1 1 , the second arm is L- shaped and at the elbow 121 g is hinged on a first fixed rotation axis 12m integral to the body of the capsule. The first fixed rotation axis 12m is arranged, beneath the plate inside the compartment 8, according to an axis Z perpendicular to said axis X and to said direction Y to form with X and Y a tern of Cartesian axes. A free end 122g of the second arm 12g acts on a first lever 12h rotatably connected, with one end, to the trigger 1 1 and with the opposite end, to a second lever 12i with respect to which it is hinged according to said direction Z. The second lever 12i is rotatably connected at its two ends to the first lever and to the first fixed rotation axis 12m. The second lever 12i is therefore adjacent in direction Z to said second arm 12g. The trigger 1 1 is hinged on a second fixed rotation axis 12n parallel to the first fixed rotation axis 12m and spaced with respect to it along the axis X (figure 1 1 ).

In summary, the articulated quadrilateral leverage has four rotary connection points: C (corresponding to the first fixed axis 12m, connection point between second arm 12g and second lever 12i), D (corresponding to the second fixed axis 12n, hinge point of the trigger 1 1 ), E (rotary connection between first and second lever), F (rotary connection between first lever and trigger). Of these rotary connection points the first two are fixed, whereas the other can translate.

According to what has been schematically shown in figure 12, following the rotation of the second arm 12g about the first axis 12m, the free end 122g moves in direction Y and thrusts the connection point E between first and second lever upwards, making the first lever rotate and consequently the connection point F about the second axis 12n (point D). Such a pure rotation allows the trigger to be lifted and the plate to be unhooked.

The trigger engages with a protrusion 90 that rises at the bottom from the plate 9.

Once the trigger has been removed the plate is raised under the action of thrust springs 14. The thrust springs 14, visible in figure 8, are arranged at the periphery of the compartment along the axis X and, according to the example described, are four in number and in opposite pairs to generate the thrust directed according to the direction of application Y necessary for the translation of the plate. The springs therefore extend between the capsule body, to which they are fixed through an end, and the plate, which has suitable hinges 91 for interlocking with opposite ends of the springs, visible in figures 7 to 1 1 .

The plate also has, again at the bottom, on the side from which the protrusion 90 projects, a wedge 92 (figures 5a, 5b, 5c) shaped like a T that engages with lips 151 of the rods 15; the translation of the plate in direction Y thus corresponds, through the engagement of the lips 151 on the inclined sides of the T-shaped wedge, to the rotation of the doors 7. The wedge 92 acts on just one pair of rods that are specular with respect to the axis X; the motion is transmitted to the remaining rods through the drive shafts 153.

A polymeric film 16 (figure 3a) able to be loaded, as will be seen shortly, with d rugs or other, for the purposes of medical therapy of a target site of the gastrointestinal tract, is positioned on the plate 9, and in particular on the surface 9a of the plate intended to be exposed towards the outside of the compartment. The film 16 is therefore contained inside the capsule when the plate 9 is in retracted position A and is exposed to the outside when the plate 9 is in extracted position B. In particular, in extracted position B, the film 16 is outside the capsule and can come into contact with the wall of the target area, adhering to it.

The polymeric film 16 preferably has a ratio between the characteristic size associated with the surface (for example the side or the diagonal in the case of a square shape) and thickness of over 10. The film can be thin (with thickness that can vary from 1 mm to Ι μηη) or ultrathin (with thickness that can vary from 1 m to a few nanometres). The surface area can range between 1 mm² and a few cm².

Advantageously, the film 16 can be made up of many layers of polymer and, in this case, it can be made through known formation techniques (layer-by-layer, spin assisted deposition, Langmuir blodgett or dipping, casting and subsequent curing of polymeric substances or other). The polymer used for the formation of the film can be of natural or synthetic origin including, for example, polylactic acid and chitosan or collagen.

The adhesion of the film 16 to the mucosa is made possible precisely by the properties of the aforementioned films, in particular physical properties (like for example the extremely low thickness that promotes the action of the forces of cohesion and capillarity), chemical properties (hydrophilicity) or, furthermore, the presence of specific chemical substances on the surface of the film, or, finally, the presence of mucoadhesive or bioadhesive substances.

The adhesion of the film 16 to the gastrointestinal wall can be promoted, as well as by the temperature and the pH of the mucosa, by the increase in contact force between the film and the gastrointestinal wall by exploiting the magnetic coupling between capsule and the external driving system. In particular, by increasing the intensity of the gradient of the magnetic field produced outside of the body of the patient at the magnets 5 inside the capsule, the attraction force between capsule and wall increases, thus increasing the pressure with which the film 16 is taken to adhere to the wall itself.

As said above, the film 16 can be loaded, for the purposes of the medical therapy to be undertaken, with:

drugs, including multifunctional microparticles (i.e. particles - of characteristic size ranging from 1 μηη to fractions of a 1 mm - that can be stimulated with, for example, electromagnetic and/or sound waves to obtain certain responses);

functional nanoparticles (particles of characteristic size ranging from 0.1 nm to 1 μηη);

Optionally, it is possible to foresee the possibility of viewing the film 16 with specific imaging techniques (like for instance echographic techniques). In this case, the film can also be loaded with bubbles, containing liquids or gases, of maximum size of the order of 1 mm.

In order to supply the electrical power necessary to actuate the shape memory wire 13, to the means for receiving images 4, possible data acquisitions etc., the capsule is equipped with an on-board electrical energy source, such as a battery or an electrical supply wireless system (not shown). The battery used can be of the rechargeable type with polymers of Lithium ions. I t ca n a l so be provided a transcutaneous electromagnetic energy transfer, based on the resonance of two coupled antennae, one external to the patient and one on-board the capsule (see for example R. Carta, et al., "Wireless power supply as enabling technology towards active locomotion in capsular endoscopy", Biosensors and Bioelectronics, 2009, Vol. 25, No. 4, pgs. 845-851 )

Optionally, there can also be DC motors that may or may not be brushless, for actuating sensors or on-board actuators.

Moreover, on-board the capsule there can also be an electronic control unit in order to transmit and receive commands, transmit videos and/or images, acquire data if the capsule is also equipped with sensors. The control unit comprises microcontrollers, wireless transmitters/receivers etc.

As with the components of the capsule intended to detect external factors, they can comprise a CMOS or CCD image sensor, which makes it possible to acquire images in real time in combination with lighting means associated with the image receiving means. The flow of data and images can then be sent to the external control unit through a wireless connection.

Examples of known sensors and equipment that can be integrated in the present capsule are described in the text "Swallowable-Capsule Technology" Mc Caffrey, et al., Tyndall National Research Institute, Pervasive Computing, I EEE, (Jan-March 2008, Volume 7 Issue 1 , Pages 23-29).

The external control un it comprises mechatronic systems for generating locomotion carried out, for example, through robotic arms that support permanent magnets or through systems of windings run through by electric current, both able to interact with the magnets inside the capsule. The driving and control unit also comprises systems for controlling locomotion that include subsystems for locating and tracking the capsule, for transmitting data and images (potentially used to control, in a closed cycle, navigation and the intervention to release the film), for commanding the system for releasing the plate.

A user interface is also provided, suitable for integrating all of the aforementioned functionalities so as to optimise the performance and the control of such functions by the operator.

The operation of the capsule according to the invention is therefore as follows. The capsule is driven along the gastrointestinal lumen through the magnetic force that is created between the inner magnets 5 and the external magnetic field and directed so as to view the intestinal wall and identify areas of interest on it. Thereafter, it is positioned so as to place the portion of the capsule body on which the grooves 6 are made in contact with the intestinal wall that needs therapy. Through roto-translation movements of the capsule, obtained by modifying the external magnetic field so as to make the capsule rotate around the longitudinal axis X, the mucus is removed from the intestinal wall to make the subsequent adhesion of the polymeric film easier, through the scraping action generated by the grooves on the wall.

Following the removal of the mucus it is commanded, through a radiofrequency signal (centred on carrier such as to get past the human biological tissues without undergoing a substantial attenuation, typically 433 MHz or 866 Mhz), to release the film 16, carried out through the lifting of the plate 9 and the simultaneous opening of the doors 7.

Once the plate has been lifted, the film 16 sticks to the intestinal wall, separating from the plate of the capsule when it is taken away by the capsule itself going away.

At the same time, by means of the particular curvature of the guides 70 on which the pivots 71 engage, the doors 7 rotate until the head 150 of each rod 15 comes out from the respective seat 71 ; the doors 7 then detach from the capsule dispersing inside the gastrointestinal tract.

Advantageously, a manual return system of the plate into the retracted position A from the extracted position B may be provided. In greater detail, the trigger 1 1 has an elastic lip 1 1 a (figure 7a) that allows the loading of the elastic release mechanism of the plate 9 through the simple manual displacement of the plate itself, from the extracted configuration B to the retracted one A. In particular, when the plate is in configuration A, the lip of the trigger is in contact with a surface (not shown in the figures) of the capsule body. This contact generates a load on the lip itself 1 1 a, which however is not able to trigger the release of the trigger, by virtue of the sizing of the articulated quadrilateral below. After the lifting of the plate 9 towards configuration B, the shape of the lower end of the trigger 1 1 ensures that the upper end thereof is unequivocally positioned so as to allow the correct engagement of the trigger 1 1 with the protrusion 90 during the return stroke from configuration B to configuration A (i.e. during the stroke with which the mechanism reloads).

Finally, again in figure 7a and in figure 7b, it is visible a protrusion that extends from the lower surface of the plate, ending with an inclined surface 93 intended to press the lever 12h during the (manual) loading stroke of the mechanism, i.e. from the extracted configuration B to the retracted one A. With reference to the articulated quadrilateral above, the inclined surface 93 is suitable for thrusting the lever 12h until the point E is taken below the conjunction line of points C and F (this ensures the safe blocking of the trigger).

The advantages of the present invention are clear from one has been described earlier; particularly, the capsule according to the invention is applicable to all the main endoscopic techniques.

The capsule has d i m en sions su ch as to be swa l l owed; in a preferred embodiment the capsule is cylindrical with a section of diameter between 10-15mm and a length of between 25-40mm.

In particular, thanks to the release of the polymeric film, the capsule carries out a topical treatment, localised to the area suffering from the pathology, without dispersion of the drug in the gastrointestinal tract (as typically occurs in the case of systemic treatment). Moreover, the release through polymeric film can lead to a reduction in the amount of drug needed with benefits relating to the health of the patient.

Therefore, the treatment with the capsule according to the invention is minimally invasive, painless and easy to tolerate for patients undergoing it. Precisely for these reasons it can be carried out in outpatient conditions without anaesthetic.

The capsule can also be used in the early diagnosis of some pathologies involving the gastrointestinal tract, such as cancer of the colon-rectum, neoplasia also in the asymptomatic phase, ulcerative colitis (inflammatory disease of the intestinal mucosa), Crohn's disease etc.

A further advantage of the capsule according to the invention is that, thanks to the ability to capture images, it makes it possible, in the endoscopic examination step, to recognise tissues potentially suffering from pathologies and/or compromised by them (for example, tissues that have blotches, redness, ulcers, bleeding etc).

The capsule can also be used for intervention treatments and in particular for suturing treatments; in these cases the polymeric film will not necessarily be loaded with a drug but the adhesion action of the film to the gastrointestinal wall will be sufficient to carry out the required suturing.

The leverage 12, also considering the low friction, makes it possible to transmit a force sufficient to keep the trigger in position given the low power required for electrical actuation. This makes it possible to reduce the size of the capsule, reducing the size of the on-board power supply means.

The manual return of the plate to the retracted position described above is particularly advantageous for the purposes of loading the plate with the polymeric film. Indeed, it is easier to load the film on the extracted plate, since, as the plate projects from the capsule body, there is no risk of bumping the film against the walls of the capsule; even light contact, considering that the film is extremely thin and very yielding, could cause the film itself to break.

Furthermore, there is the possibility of passing from the extracted position to the retracted one with a simple mechanical action that does not entail additional energy consumption, which should be extracted from on-board power supply systems.

The present invention has been described up to now with reference to its preferred embodiments. It should be understood that there can be other embodiments that stem from the same inventive core, all of which are covered by the scope of protection of the claims given below.

Claims

1 . A swa llowable capsule for the local therapy of a target site in the gastrointestinal tract (Gl) of a patient, said swallowable capsule comprising a capsule body (1 ) with a longitudinal axis (X), said capsule body being equipped with image sensor means (4) to acquire images of said gastrointestinal tract (Gl), said capsule further comprising a driving and orienting wireless system (5) adapted to interact with an external unit for the receiving of information and the driving of said capsule, said capsule being characterised in that it comprises a compartment (8) formed in said capsule body (1 ), said compartment (8) being adapted for the housing of polymeric film means (16), said capsule also comprising supporting and releasing means (9, 12) for moving said polymeric film means (1 6) according to a direction (Y) of application perpendicular to said longitudinal axis (X), from a retracted position (A), wherein said polymeric film means (16) are contained inside said compartment (8), to an extracted position (B) wherein said polymeric film means (16) project from said compartment (8) to make contact with said target site of said gastrointestinal tract (Gl).

2. The swallowable capsule according to claim 1 , wherein said supporting and releasing means (9, 12) comprise a support plate (9) movable according said direction of application (Y), from said retracted position (A), wherein said plate (9) is housed inside said compartment (8), to said extracted position (B) wherein said plate (9) and, in particular, at least an upper surface (9a) of said plate (9) projects from said compartment (8), said polymeric film means (16) laying on said upper surface (9a).

3. The swallowable capsule according to claim 2, wherein said supporting and releasing means (9, 12) comprise shape memory means (12, 13) acting to move said support plate (9) according said direction of application (Y), said shape memory means (12, 13) comprising in turn a shape memory wire (13) that moves said support plate (9) through a leverage (12).

4. The swallowable capsule according to claim 3, wherein said leverage (12) activates a trigger (1 1 ) that locks said support plate (9) in said retracted position (A) engaging with a protrusion (90) that projects from a lower surface (9b) of said support plate (9).

5. The swallowable capsule according to claim 4, wherein said support plate (9) is engaged to thrust springs (14) that are pressed when said trigger (1 1 ) is engaged with said protrusion (90), said springs (14) pushing said supporting plate according to said direction of application (Y) when said trigger (1 1 ) releases said protrusion (90).

6. The swallowable capsule according any of the claims from 2 to 5, wherein said support plate (9) is engaged on guide pivots (10) that project from said capsule body (1 ) according said direction of application (Y) inside said compartment (8), said guide pivots (10) permitting the movement of said support plate (9) along said direction of application (Y).

7. The swallowable capsule according to claims 2-6, wherein said capsule body comprises openable doors (7) adapted to close said compartment (8), said doors (7) opening to expose said compartment (8) with a movement of rotation according to said longitudinal axis (X) by rods (1 5), said rods being rotated under the effect of the engagement of lips (1 51 ) of said rods (1 5) on a wedge (92) projecting from said support plate (9), said doors (7) opening according to the movement of said support plate (9) along said direction (Y).

8. The swallowable capsule according any of the previous claims, wherein said capsule has a longitudinal development according said longitudinal axis (X) and is substantially cylindrical, said capsule comprising respective front and rear caps (2, 3) in correspondence of ends of said capsule, said front cap (2) containing said image sensor means (4) and relative lightening means.

9. The swallowable capsule according to claim 8, wherein inside to at least one of said caps (2, 3) are arranged driving means of said driving and orienting wireless system (5), like at least one magnet (5) adapted to interact with a magnetic field external to said capsule and generated by said external unit.

10. The swallowable capsule according to any of the previous claims, wherein on a outer surface of said capsule body a groove (6) is formed along said longitudinal axis (X), said groove (6) bei ng adapted to remove the mucus on a wall of said gastrointestinal tract (Gl) by roto-translational movement of said capsule.

1 1 . The swallowable capsule according to any of the previous claims, wherein a electronic control unit is provided to transmit and receive orders, videos and/or images from said image sensor means and to acquire information from sensor means of said capsule, said electronic control unit comprising wireless microcontroller and/or transmitter/ receiver.

12. The swallowable capsule according to any of the previous claims, wherein a electrical energy source is provided on board of said capsule, said electrical energy source being a battery or a electrical supply wireless unit to the acting of said shape memory means, said image sensor means, said sensor means etc..

13. The swallowable capsule according to any of the claims from 9 to 12, wherein said external driving unit comprises mechatronical system realised by robotic arms that support permanent magnets or by system of windings run through by electric current adapted to interact with said at least one magnet (5).

14. The swallowable capsule according to any of the previous claims, wherein on board of said capsule an electric motor is provided to the activation of said sensors and/or actuator on board.

15. The swallowable capsule according to any of the previous claims, wherein said polymeric film means are a polymeric film (16) adapted to support therapeutic agents for said local therapy.

16. The swallowable capsule according to claim 15, wherein said polymeric film is loaded with drugs.

17. The swallowable capsule according to claim 15, wherein said polymeric film is loaded with nano-functional particles

18. The swallowable capsule according to claim 15, wherein said polymeric film is loaded with blisters, containing liquids or gas, with maximum dimension in the order of 1 mm.

19. The swallowable capsule according to any of the previous claims, wherein said polymeric film (16) has a ratio between the characteristic dimension associated with the surface, for example the side or the diagonal, and the thickness greater than 10.

20. The swallowable capsule according to any of the previous claims, wherein said polymeric film (16) is made with a natural or synthetic polymer.