An infusion device for releasing medicines

This invention relates to an infusion device. In particular, the invention relates to an infusion device for releasing medicines such as, for example, insulin.

There are prior art devices for releasing medicines in the body of a patient. Such devices comprise catheters for delivering fluid which include a cannula suitable for insertion into a cavity of the body of a patient. In particular, the cannula allows the medicine to flow and hence to deliver the medicine to the patient.

Such devices are provided with a base portion and a cap portion which define a body that partly contains the catheter. The cannula protrudes, in fact, from the base portion in such a way as to allow it to be inserted into the body of the patient.

The base portion comprises a sticking plaster to allow the device to be attached to the patient. The sticking plaster comprises a peelable sheet and an adhesive component. In particular, the peelable sheet is removable in such a way as to make accessible the adhesive component intended to adhere to the skin of the patient.

The cap portion is fixed to an insertion needle which is designed to penetrate the skin during a first insertion of the cannula. The insertion needle is, in fact, of a size such that it can be housed in the catheter and comes out of the cannula in such a way that it can reach and penetrate the skin so that the subsequent first insertion of the cannula can be made possible.

After removal of the cap portion and the needle attached to it, which is pulled out of the catheter, the device is ready to receive the medicine to be released, which is dispensed through the cannula.

Disadvantageously, these devices have structures and dimensions such that the assembly and/or use is difficult.

In particular, from a structural point of view, the Applicant underlines that the prior art devices are not able to guarantee efficient dispensing of the medicine. The prior art devices have structures such that, once the medicine has been dispensed through the cannula, the medicine stagnates in specific portions of the cannula. In other words, the prior art devices, that is to say, their components, have structures which create dead spaces which may lead to a stagnant medicine in them.

Stagnant medicine, for example insulin, inside the cannula is a problem from the hygiene point of view as well as from the point of view of the therapy, where the dose of medicine required for the therapy of user is not entirely dispensed.

For example, with reference to the paediatric sector, the Applicant underlines that for a dose of approximately 5 pl, some of the prior art devices have dead spaces which lead to a stagnant volume of 2.6 pl of the medicine in them, resulting in an error in the dispensing of the medicine of approximately 50%.

Moreover, the Applicant underlines that in other prior art devices, making reference, for example, to a dose of medicine for adults equal to 50 pl, the dead spaces are such that a stagnant volume of 7.5 pl is reached (thus making them unsuitable for paediatric use).

Moreover, the prior art devices are generally difficult to assemble and dismantle for a non-expert technician in light of the particular complexity of the various components. In other words, a non-expert technician might have numerous difficulties in the assembly the device so that all its components are correctly aligned and stable when the device is closed, in such a way that, when in use, the positioning of the insertion needle in the catheter is not found to be difficult.

Patent document US 2008/243085 describes a method for mounting an infusion set which includes making an infusion base of the infusion set adhere and inserting a cartridge of a cannula of the infusion set in an opening of the infusion base.

Patent document US 2014/039453 describes an infusion set for to be used with an insertion device. The infusion set includes a cap, which encapsulates an upper resilient partition and a lower resilient partition of a base, and includes at least one radial door for receiving the insertion of a bevelled cannula when an extension pole is engaged with the infusion set in a direction substantially parallel to the cutaneous surface.

Patent document US 9795777 describes an infusion system, comprising a base and a fluid connector which can be removably connected to it. The fluid connector includes a portion of the path of the fluid and at least one snap-on connection, which can be moved to connect the portion of the path of the fluid, and can be moved to a snap-on position wherein at least one portion of the snap-on connection extends in the path of the fluid.

The technical purpose of the invention is therefore to provide an infusion device or releasing medicines which is able to overcome the drawbacks of the prior art.

The aim of the invention is therefore to provide an infusion device for releasing medicines which allows the medicine to be dispensed correctly without stagnations and guaranteeing a greater therapeutic performance.

A further aim of the invention is to provide an infusion device for releasing medicines which is easy to use and assemble.

A further aim of the invention is to provide an infusion device for releasing medicines which can be easily used and assembled by non-expert or unsure operators during a first use, which allows all the components to be aligned in the correct manner in a simple and effective manner.

The technical purpose indicated and the aims specified are substantially achieved by a infusion device for releasing medicines comprising the technical features described in one or more of the appended claims. The dependent claims correspond to possible embodiments of the invention.

In particular, the technical purpose and aims specified are substantially achieved by an infusion device for releasing medicines comprising a catheter, extending along a respective axis of extension coinciding with the main axis of the device, provided with a first portion and a second portion shaped in the form of a cannula. The second portion shaped in the form of a cannula is designed to be inserted into a cavity in the body of a patient.

The device also comprises a collector which can be engaged above the first portion of the catheter and provided with a lower central portion and an upper central portion defining a channel for inserting the medicine into the catheter. The lower central portion is counter-shaped with respect to the first portion in such a way as to be at least partly inserted in an interlocking manner in the first portion.

The device also comprises a silicone cap which can be perforated which can be engaged above the collector and provided with a lower portion counter-shaped with respect to the upper central portion of the collector in such a way as to be inserted in an interlocking manner in the upper central portion.

The device also comprises a base provided with an opening defining a supporting seat for an assembly defined by the catheter, the collector and the silicone cap when engaged with each other and through which the second portion of the catheter protrudes, and a covering element which can be removably snap-on connected to the base which defines with the opening, in a snap-on connection configuration with the base, a housing in which an assembly defined by the catheter, the collector and the silicone cap is received and retained.

Advantageously, the assembly of catheter, collector and silicone cap forms a single body with reduced dead spaces so as to prevent the formation of stagnations.

Advantageously, the interlocking clearance between catheter, collector and silicone cap (as well as between the base and the covering element) and the dimensional proportions between the components make it possible to obtain a solid, stable device which can be easily assembled even by a nonexpert technician. Further features and advantages of the invention are more apparent in the non-limiting description which follows of a non-exclusive embodiment of an infusion device for releasing medicines.

The description is set out below with reference to the accompanying drawings which are provided solely for purposes of illustration without restricting the scope of the invention and in which:

Figure 1A is a schematic exploded representation of the device according to the invention;

Figure 1 B is a schematic exploded representation of some components of the device according to the invention;

Figure 2 is a schematic representation of a front cross-section of the device according to the invention;

Figure 3 is a schematic representation of the front cross-section of Figure 2, wherein the closing element is absent.

With reference to the accompanying drawings, the numeral 1 denotes in its entirety an infusion device for releasing medicines which, for simplicity of description, will hereafter be referred to as device 1 .

The term “medicine” is used to mean any type of medical fluid such as, for example, insulin.

The device 1 comprises a catheter 2 having a first portion 2a and a second portion 2b. The catheter 2 extends longitudinally along a respective axis of extension "X", shown in Figure 1A as the main axis of the entire device 1. In particular, the second portion 2b is shaped in the form of a cannula and is designed to be inserted into a cavity in the body of a patient.

Preferably, and as shown in the accompanying drawings, the second portion 2b has a pointed end 2b'. In other words, the end 2b' has a decreasing cross-section (that is, tapered) away from the first portion 2a in such a way as to facilitate an insertion of the device 1 in a condition of use, as will become clearer as this description continues.

Preferably, and as shown in the accompanying drawings, the first portion 2a of the catheter 2 comprises a tubular seat 2c forming a step 2d. In other words, the tubular seat 2c comprises two portions, a lower portion and an upper portion wherein the lower portion has a smaller cross-section than the upper portion. The tubular seat 2c of the first portion 2a is in communication with a conduit formed in the second portion 2b.

It should be noted that, in this text, the term "lower" is used to mean what is directed, in use, towards the patient, whilst the term "upper" means what is directed, in use, to the side opposite the patient.

Preferably, the first portion 2a has an outer portion 2e having a substantially cylindrical or truncated cone shape.

The device 1 also comprises a collector 3 which can be engaged above the first portion 2a of the catheter 2.

The collector 3 has a lower central portion 3a and an upper central portion 3b. The two central portions 3a and 3b define a channel for inserting the medicine into the catheter 2. In other words, the collector 3 has a main body in which is defined a channel for the medicine which, when in use, is in communication with the conduit of the catheter 2.

The lower central portion 3a is counter-shaped with respect to the first portion 2a in such a way as to be at least partly inserted in an interlocking manner in the first portion 2a.

Preferably, the lower central portion 3a of the collector 3, as shown in the accompanying drawings and shown in detail in Figure 1 B, comprises a tubular element 3c provided with a respective step 3d counter-shaped with respect to the tubular seat 2c of the first portion 2a of the catheter 2. In other words, the step 2d of the tubular seat 2c defines an abutment for the lower central portion 3a of the collector 3, that is, of the step 3d of the tubular element 3c.

The tubular element 3c widens radially to form the respective step 3d.

The channel defined in the central portions 3a and 3b directly faces the conduit of the second portion 2b of the catheter 2 to ensure that the medicine is fed into it.

Preferably, the collector 3 comprises a lower recess 3e counter-shaped with respect to the first portion 2a of the catheter 2 in such a way as to fit at least partly the outer portion 2e of the catheter 2. In other words, the lower recess 3e is counter-shaped with respect to at least part of the outer portion 2e in such a way as to interlock on it, covering at least a portion.

The collector 3 comprises an outer portion 3f which delimits externally the collector 3 and internally the lower recess 3e.

Preferably, the upper central portion 3b of the collector 3 has a flared inner shape whilst the lower central portion 3a of the collector 3 is tubular in shape. In other words, a continuous channel "C" is defined, between the upper central portion 3b and the second portion 2b of the catheter 2 which has the above-mentioned flared shape in the upper central portion 3b, a tubular shape in the lower central portion 3a which is in communication with the tubular conduit formed in the second portion 2b.

Preferably, the lower central portion 3a has an outer portion having a substantially cylindrical shape.

The dimensional ratios between the catheter 2 and the collector 3 allow them to be securely connected to each other in an assembly configuration of the device 1 . Moreover, since the first portion 2a of the catheter 2 and the lower central portion 3a (as well as the lower recess 3e) of the collector 3 are counter-shaped with respect to each other, the two components are easily mountable relative to each other in such a way as to reduce, if not completely eliminate, the presence of dead spaces between them. In this way, during insertion of the medicine, the continuous channel "C" defined between the upper central portion 3b of the collector 3 and the second portion 2b of the catheter 2 makes it possible to reduce the quantity of stagnant material, eliminating portions in which such stagnations can form. The device 1 also comprises a silicone cap 4 which can be perforated. The silicone cap 4 can be engaged above the collector 3 and it is provided with a lower portion 4a counter-shaped with respect to the upper central portion 3b of the collector 3 in such a way as to be inserted in an interlocking manner in the upper central portion 3b. Preferably, as shown in the accompanying drawings, the lower portion 4a of the silicone cap 4 comprises a conical portion 4b counter-shaped with respect to the upper central portion 3b of the collector 3.

Preferably, the conical portion 4b extends with an angle of extension greater than or equal to 15° and less than or equal to 35°, preferably less than or equal to 20° or equal to 30°. In other words, the conical portion 4b extends with an inclination relative to the axis of extension "X" of between 15° and 35°, preferably between 20° and 30°. In other words, the conical portion 4b of the silicone cap 4 is shaped in such a way as to occupy entirely the flared inner portion of the upper central portion 3b of the collector 3 so that it interlocks in it and reduces the possible dead spaces which may generate stagnations of the medicine when the silicone cap 4 is inserted into the collector 3.

In particular, as shown in Figures 2 and 3, the single free space in the upper central portion 3b is defined by the space "V" (which forms part of the upper central portion 3b but is not occupied by the conical portion 4b of the silicone cap 4, even though the conical portion 4b is counter-shaped with respect to the upper central portion 3b) which is sufficient to allow the passage of the medicine to the second portion 2b of the catheter 2.

In this way, the lower portion 4a of the silicone cap 4 faces directly the channel portion defined by the lower central portion 3a of the collector 3.

The lower portion 4a of the silicone cap 4 comprises a lower recess 4c counter-shaped with respect to the upper central portion 3b of the collector 3 in such a way as to fit at least partly the outer portion 3f of the collector 3. In other words, the lower recess 4c is counter-shaped with respect to at least part of the outer portion 3f of the collector in such a way as to be engaged on it, covering at least a portion.

The dimensional ratios between the collector 3 and the silicone cap 4 allow them to be securely connected to each other in an assembly configuration of the device 1 . Moreover, since the upper central portion 3b of the collector 3 and the lower portion 4a (as well as the lower recess 4c) are counter- shaped with respect to each other, the two components are easily mountable relative to each other in such a way as to reduce, if not completely eliminate, the presence of dead spaces and liquid leaks between the two. In this way, during insertion of the medicine, the continuous channel "C" defined between the upper central portion 3b and the second portion 2b (and in particular extending between the lower central portion 3a and the second portion 2b) makes it possible to reduce the quantity of stagnant material, eliminating portions in which such stagnations can be formed.

It should be noted that the silicone cap 4 comprises a plate and that the conical portion 4b of the lower portion 4a is central and protrudes downwards from the plate.

Moreover, the silicone cap 4 comprises a respective outer wall, located at the end of the plate, which delimits the inside of the lower recess 4c. The outer wall is annular and, in this way, may enclose externally the outer portion 3f of the collector 3 in such a way that the outer portion 3f can at least partly interlock in the lower recess 4c. In this way, an upper part of the collector 3 can be placed in contact with the plate.

The silicone cap 4 also has an upper portion 4d, aligned with the conical portion 4b, which protrudes above the plate. The upper portion 4d is substantially cylindrical in shape and is central. It should be noted that the upper portion 4d and the conical portion 4b are located on opposite sides of the plate.

The silicone cap 4 also comprises at least one sealing element 4e configured for making a fluid-tight seal with the collector 3 and/or with a covering element 6.

The sealing element 4e may be made as a single piece with the plate and may be shaped like a protruding projection, positioned in the plate above and/or below, which may be respectively concentric with the upper portion 4d, and/or the conical portion 3d.

Alternatively, the sealing element 4e may be made by means of an O-ring, positioned above and/or below, which may be, for example, housed in a respective upper and/or lower groove of the plate.

The projection protruding below, or the lower seal, are configured to make contact with and engage in a sealed fashion with the upper part of the collector 3.

Preferably, according to a version not illustrated, the silicone cap 4 may comprise a plurality of sealing elements, for example a pair of sealing elements which are concentric with each other.

The silicone cap 4 advantageously allows the portions of the catheter 2 and of the collector 3, which enter directly into contact with the medicine to be injected into the body of the patient/user, to be isolated from a hygiene point of view. In particular, the hygienic isolation condition is guaranteed when the device 1 (in particular the second portion 2b shaped in the form of a cannula) is inserted in the cavity of the body of the patient.

More specifically, the silicone cap 4 allows insertion of a needle of a syringe to allow the introduction into the liquid in the channel formed between the central upper portion 3b and the second portion 2b, in such a way that it is inserted close to the tubular portion of channel defined in the lower central portion 3a of the collector 3, inserted in an interlocking manner in the first portion 2a of the catheter 2.

In use, the needle is made to enter the silicone cap 4 and, passing through the conical portion 4b (that is, the lower portion 4a), allows the liquid to be poured close to the tubular channel formed in the lower central portion 3a of the collector 3 where the liquid flows into the conduit of the second portion 2b of the catheter 2 and consequently entering the body of the patient.

Preferably, the silicone cap 4 may be perforated several times, continuing to guarantee the necessary isolation during use of the device 1 .

The device 1 also comprises a base 5 provided with an opening 5a defining a supporting seat for the assembly defined by the catheter 2, the collector 3 and the silicone cap 4 when engaged with each other (and interlocked). The second portion 2b of the catheter 2 protrudes through the opening 5a of the base 5. A bottom of the first portion 2a rests on the supporting seat which surrounds the opening 5a. Preferably, the bottom has a flat shape or other shape suitable for stably maintaining the assembly on the supporting seat.

Preferably, and as shown in Figures 2 and 3, a bottom of the outer portion 3f of the collector 3 is also resting on a portion of the supporting seat which surrounds the opening 5a. The bottom of the outer portion 3f has the same shape as the bottom of the first portion 2a or other suitable shape, determined by the shape of the supporting seat, for stably maintaining the assembly on the supporting seat.

In other words, the opening 5a has the dual purpose of allowing the passage of the second portion 2b of the catheter 2 and allowing a stable support of the assembly by means of the catheter 2 and the collector 3 (and the silicone cap 4 if its dimensions allow it) on the supporting seat which surrounds the opening 5a. For this reason, the opening 5a allows the components to be held on the bottom of the device 1 , as will become clearer as this description continues.

Preferably, the base 5 has a surface such as to make the device 1 suitable for resting on the body of the patient. The base 5 also comprises a sticking plaster action to allow the device 1 to be attached to the body of the patient. The sticking plaster (not illustrated) comprises a peelable sheet and an adhesive component. In particular, the peelable sheet is removable in such a way as to make the adhesive component accessible, so as to allow the device 1 to be attached to the body of the patient.

The device 1 also comprises a covering element 6 which can be removably snap-on connected to the base 5 in such a way as to form with the opening 5a, in a snap-on configuration with the base 5 (that is, in the assembled configuration of the device 1 ), a housing in which the assembly defined by the catheter 2, the collector 3 and the silicone cap 4 is received and retained. In other words, the base 5 and the covering element 6 define a protective shell as well as the external structure of the device 1 with which the patient/user comes into contact in order to manipulate the device 1 . Preferably, the covering element 6 comprises a protruding ring 6a countershaped with respect to a respective annular recess 5c of the base 5 which is configured to obtain the snap-on configuration (that is, the assembly configuration of the device 1 ).

The protruding ring 6a is positioned below in the covering element 6.

The projection protruding above, or the upper seal, of the sealing element 4e are configured to make contact with and engage in a sealed fashion with a lower part of the covering element 6.

Advantageously, the base 5 and the covering element 6 allow a device 1 to be obtained with an assembly and/or disassembly which is further improved compared with prior art devices. In particular, the catheter 2, the base 5 and the collector 3 can be easily interlocked to each other so as to obtain a single assembly which can be rested on the base 5 and held in a seat defined by the opening 5a and by the covering element 6.

During an assembly of the device 1 , the catheter 2 is interlocked to the collector 3 (so that the different counter-shaped components make contact with each other, forming the interlocking) and the same procedure is performed between the collector 3 and the silicone cap 4.

The assembly thus obtained is rested on the seat surrounding the opening 5a and defined by the opening 5a so that the second portion 2b of the catheter protrudes from the bottom of the base 5. More in detail, resting the bottom of the first portion 2a (and, as shown in the accompanying drawings, the bottom of the outer portion 3f of the collector 3) rests the entire assembly, the components of which have been assembled on each other. Advantageously, the structure defined by the catheter 2, by the collector 3 and by the silicone cap 4 is kept stably aligned with the axis of extension "X" by the opening 5a in such a way as to facilitate closing with the covering element 6.

When the protruding ring 6a of the covering element 6 is interlocked in the annular recess 5c of the base 5, the snap-on configuration is obtained which defines the housing which holds together the catheter 2, the collector 3 and the silicone cap 4.

It should be noted that the sealing element 4e of the silicone cap comes into contact with the covering element 6 and/or with the collector 3 and therefore prevents unwanted escape of the liquid which is introduced for the patient in the upper central portion 3b of the collector 3. In addition, the sealing element 4e isolates the upper central portion 3b from the outside, preventing the penetration of water into the device 1 when the patient wishes to take a bath or a shower.

In effect, the sealing element 4e, which is concentric relative to the upper portion 4d, and/or the conical portion 3d, is positioned in the plate (radially) in a suitable position such as to effectively prevent both the escapes of liquid and the penetration of water.

Preferably, as shown in Figure 2, the device 1 also comprises a removable closing element 7 provided with a needle 7a designed to penetrate the skin of the body of the patient during a first insertion of the second portion 2b shaped in the form of a cannula.

In particular, the needle 7a can pass through the catheter 2 and come out from the free end of the second portion 2b (coinciding with the portion of the catheter 2 facing the body of the patient) in such a way that the skin of the patient can be reached and penetrated during the first insertion of the cannula. In this regard, it should be noted that the covering element 6 has a relative opening 6c designed to allow the passage of the needle 7a of the closing element 7 (or of the needle of the syringe in order to penetrate the silicone cap 4).

In the closed configuration, the upper portion 4d of the silicone cap 4 passes at least partly through the opening 6c of the covering element 6.

Preferably, the needle 7a may have an end having an “anvil-like" shape as shown in the accompanying drawings. This shape of the end of the needle 7a, together with the pointed end 2b' of the catheter 2, facilitates insertion of the device 1 in the body of the patient even in the case of manual application (and therefore not with instruments capable of applying a predetermined and reproducible force). In other words, the needle 7a and the end 2b' of the catheter 2 define a continuous tip which easily penetrates the skin of the patient, avoiding, for example unwanted raising of the end 2b' relative to the catheter 2.

Moreover, in a closed configuration, wherein the needle 7a passes through the second portion 2b of the catheter 2, the needle 7a perforates the silicone cap 4 in a non-destructive manner. In other words, in the closed configuration, the closing element 7 is removably snap-on connected to the covering element 6 with the needle 7a which perforates the silicone cap 4 passing through the second portion 2b of the catheter 2.

Preferably, the closing element 7 comprises tubular engaging elements 7b extending parallel to the needle 7a and wherein the covering element 6 comprises, in an upper portion of it, respective recesses 6b counter-shaped with respect to the tubular elements 7b which are configured for retaining the closing element 7 in the covering element 6 during the first insertion of the second portion 2b shaped in the form of a cannula.

The closing element 7 has a structure which makes it easy to grip by a patient/user. In the accompanying drawings, the closing element 7 is provided with gripping portions 7c which allow the easy gripping by the patient/user.

Preferably, as shown in Figure 1 , the device 1 also comprises a protective cap 8 removably connected to a lower portion of the opening 5a of the base 5. In other words, a lower portion of the opening 5a defines a snap-on seat for a portion of the protective cap 8 which is therefore able to surround the second portion 2b of the catheter (that is to say, the portion of needle 7a which protrudes from the portion 2b of the catheter 2).

Preferably, the protective cap 8 has a snap-on portion having a thread in such a way as to screw it onto the lower portion of the opening 5a of the base 5, which defines the snap-on seat.

Preferably, the protective cap 8 has a bayonet snap-on portion in such a way as to form the reversible connection with the opening 5a of the base 5 which will have respective portions for the bayonet snap-on connection of the protective cap 8.

Advantageously, the invention is able to overcome the drawbacks of the prior art.

In particular, the Applicant has carried out various tests in order to demonstrate the technical advantages obtained by the invention.

For example, hydraulic tests have been carried out relative to the device 1 . The hydraulic tests performed on various devices 1 wherein the catheter 2, the collector 3 and the silicone cap 4 had different dimensional ratios. In particular, the tests were performed with devices wherein the silicone cap 4 had a conical portion 4b with angles of extension of 30° or 20°. The tests have been carried out by simulating the use of the devices 1 on patients, taking into account factors such as age, past experience with similar devices, life styles and therapeutic plan as well as the need for insulin.

The volume of medicine (in particular insulin) applied refers to the minimum bolus in adult patients.

The tests were carried out by pressurising the devices 1 at 0.2 bar and 0.5 bar to check for the absence of leaks (that is, the hydraulic seal), simulating the pressure exerted during underwater activity at a maximum depth of 5 m. Even more stressful tests have also been performed, with pressures of up to 5 bar.

In particular, the tests were carried out to guarantee the absence of leaks and loss of liquid into the device 1 itself (that is, of its components) using a permeating liquid dye. In particular, the test was carried out at a time interval of twenty minutes from each other with two injections performed per test. In order to check the effective seal during use, the device 1 used (that is, the various components) has been made of transparent material.

Tests have also been carried out on the silicone cap 4 executing a stress test relative to the penetration of the cap with needles for commercial insulin and simulating multiple injections (up to eighty). These tests have also been performed to assess the compatibility of the dimensions of the cap which can be perforated with needles for commercial insulin (8 mm, 6 mm and 4 mm in length).

The above-mentioned tests showed that the device 1 does not have any type of internal leak of the medicine.

In particular, all the tests have shown that the liquid comes out normally from the second portion 2b of the catheter 2 (even after the second injection) without dispersion of the liquid between the catheter 2 and the collector 3 or between the collector 3 and the silicone cap 4 with a maximum emptying time of around 15 minutes.

The tests for perforating the silicone cap 4 have demonstrated, again using the colorant, that there were no dispersion of the liquid inside the silicone cap 4, that is to say, on the central upper portion 3b of the collector.

Tests have also been carried out wherein the device 1 has been immersed entirely in water and it has been demonstrated that there was no infiltration of water inside it. In particular, the test was carried out by assessing the formation or absence of bubbles at the immersion of the device 1 in water. The test has therefore shown that the device 1 may be immersed also by a patient who wishes to have a bath or a shower without the risk of water penetrating into the device 1 .

Advantageously, the assembly of catheter 2, collector 3 and silicone cap 4 forms a single body with reduced dead spaces so as to prevent the formation of stagnations.

Advantageously, the device 1 guarantees that stagnant medicine is not formed inside the various components of the device 1 and therefore guarantees that a medicine is correctly expelled from the catheter 2.

In particular, the Applicant underlines that in the paediatric sector, unlike the prior art devices, the particular internal shape of the device 1 guarantees, during the dispensing of a dose of approximately 5 pl, a maximum stagnant volume of 1.1 pl, thus resulting in a maximum dispensing error of approximately 20%. In other words, the device 1 is able to guarantee a greater therapeutic safety than similar devices. For this reason, the stagnant volume held in the continuous channel "C" is considerably reduced (if not eliminated) compared with the prior art devices.

Moreover, the device 1 guarantees that the medicine is not dispersed into the device 1 . Moreover, the device 1 is impermeable and can therefore also be used under water by a user who must wear it for a long time.

Advantageously, the interlocking clearance between catheter 2, collector 3 and silicone cap 4 (as well as between the base 5 and the covering element 6) and the dimensional proportions between the components make it possible to obtain a solid, stable device 1 which can be easily assembled even by a non-expert technician.