SUBCUTANEOUS DRUG ADMINISTRATION DEVICE

Abstract

The invention relates to a subcutaneous drug delivery device, comprising an injection needle (34) configured to receive the drug from a cartridge through a flexible tube (36) and to inject the drug into a patient, and an injection needle displacement mechanism (60) configured to move the injection needle (34) between a rest position in which it is entirely disposed inside the device and an injection position in which it protrudes from the device.Such a mechanism (60) comprises a pusher (63) movable from a first operating position in which the injection needle (34) is in the rest position to a second operating position in which the injection needle (34) is in the injection position, and a support member (62) for the injection needle (34) movable between a first operating position in which the injection needle (34) is in the rest position and a second operating position in which the injection needle (34) is in the injection position. The support member (62) comprises, on an outer lateral surface (62a) thereof, a coupling portion coupled to the flexible tube (36).The mechanism (60) further comprises a first compression spring (65) associated with the thrust member (63) and configured to push the thrust member (63) from the first operating position to the second operating position, and a second compression spring (64) associated with an inner surface (62b) of the support member (62) and configured to push the support member (62) from the second operating position to the first operating position. The two springs (64, 65) extend along different axes (C, D).The mechanism (60) has a first operating configuration in which the thrust member (63) is coupled to the support member (62) and the first spring (65) moves the thrust member (63) from the first operating position to the second operating position and the support member (62) from the first operating position to the second operating position by loading the second spring (64), and a second operating configuration in which the thrust member (63) is decoupled from the support member (62) and the second spring (64) moves the support member (62) from the second operating position to the first operating position. Figure 22 for the abbreviation.

Description

Title of the invention: DEVICE FOR SUBCUTANEOUS ADMINISTRATION OF A DRUG Technical field of the invention

[0001] The present invention relates to a device for subcutaneous administration of a drug.

[0002] In particular, the device of the present invention falls within the category of "infusion pumps" as defined by the FDA (US Food and Drug Administration) and relates, more specifically, to a wearable device, that is, one configured to be applied to a patient's body to allow the subcutaneous administration of a predetermined dose of medication. The application of the device to the patient's body is performed by a user, for example, a physician or nurse, or by the patient themselves. Technical background

[0003] Examples of administration devices of the type discussed above are described in EP 3439715B1 and WO 2020 / 128821A1.

[0004] In all body-worn administration devices, the drug is initially contained in a cartridge housed inside the device and is transferred into the patient's body via a fluidic pathway.

[0005] In the present description and in the following claims, the term "fluidic path" is used to designate any element or set of elements which is configured to be connected, at a first end thereof, to the cartridge housed inside the delivery device and comprising, at an end thereof opposite to the first end mentioned above, an injection needle intended to be inserted into the patient's body to allow the transfer of the drug from the cartridge to the patient's body.

[0006] Typically, the cartridge includes a cylindrical container, made of a plastic or glass material, a piston that can slide inside the container to push the drug out of the container and a pierceable septum that ensures the sterility of the container until the start of the therapy administration.

[0007] Typically, the fluidic path includes a drilling needle configured to pierce the pierceable septum of the cartridge and a flexible tube that puts the drilling needle into fluidic communication with the injection needle.

[0008] In such devices, the cartridge container is kept closed by the pierceable septum until administration of the drug is required. When such administration is required, the piercing needle pierces the pierceable septum and opens the fluidic path, allowing the drug to reach the patient by first passing through the piercing needle, then through the flexible tube and finally through the injection needle, due to the thrust exerted by the piston on the drug inside the container.

[0009] Obviously, the administration of the drug to the patient takes place after the insertion of the injection needle into the patient's body. Such insertion occurs following the activation of a displacement mechanism configured to move the injection needle between a rest position in which the injection needle is fully retracted inside the device and an injection position in which the injection needle protrudes from the device and penetrates the patient's skin.

[0010] Typically, the movement of the injection needle from the rest position to the injection position and / or vice versa is obtained due to the pushing action exerted by respective springs on the member which supports the injection needle.

[0011] US patent 2021 / 0162126A1 describes an auto-injector comprising a housing and a needle that can assume two positions: one in which it is retracted into the housing and the other in which it protrudes from the housing to penetrate the patient's skin. The movement between the two positions can be electronically activated.

[0012] EP 1764125B1 and WO 2002 / 02165A2 disclose embodiments of manually operated mechanisms for moving the injection needle.

[0013] In particular, in the embodiment of figures 19 and 20 of WO 2002 / 02165A2, two coaxial compression springs 232 and 265 are provided, which are arranged one outside of the other and both around the member 270 which supports the injection needle.

[0014] The Applicant observed that this arrangement makes it impossible to access the component 270 laterally to connect the flexible tube intended to connect the piercing needle for puncturing the septum of the cartridge to the injection needle. This flexible tube must therefore necessarily be connected to a superior surface of the component 270 and extend vertically or almost vertically above said superior surface, then bend to reach the piercing needle. However, this bend cannot be too pronounced, otherwise there would be a risk of reducing the cross-section of the flexible tube and not being able to guarantee a regular flow of the drug to the injection needle. This implies that devices manufactured according to the embodiment described above must have a certain height to allow for a suitable arrangement of the flexible tube.Inevitably, these devices are therefore bulky and uncomfortable, given that they are typically intended for long-term use by the patient.

[0015] The Applicant therefore felt the need to produce more compact devices than those described above.

[0016] The Applicant observed that in EP 3862037A1, a device is described in which the flexible tube can laterally reach the component that supports the injection needle. In this device, the extraction of the injection needle from the device and the retraction of the injection needle into the device occur due to the pushing action exerted by respective torsion springs.

[0017] However, according to the Applicant, it would be preferable to use compression springs since only these allow optimal control of the needle drive force for extracting the injection needle from the device and for retracting the injection needle into the device. This control is necessary to minimize the pain felt by the patient during the insertion and removal of the injection needle.

[0018] The technical problem underlying the present invention is to produce a subcutaneous drug administration device in which the flexible tube is connected to the lateral surface of the organ that supports the injection needle, so as to be able to reduce as much as possible the height of the device and thus make it sufficiently compact and comfortable for prolonged use by the patient, and in which the extraction of the injection needle from the device and the retraction of the injection needle in the device are carried out by providing compression springs, so as to be able to optimally control the driving force of the injection needle during the insertion of the injection needle into the patient's body and the extraction of the injection needle from the patient's body. Summary of the invention

[0019] The present invention therefore relates to a device for subcutaneous administration of a drug, comprising: - a cartridge comprising a container holding the drug and a pierceable septum coupled to one end of said container; - a drilling needle configured to pierce the pierceable septum; - an injection needle configured to inject the drug into a patient, said injection needle defining with said piercing needle a fluidic path configured to be traversed by the drug during subcutaneous administration of the drug; - a fluidic path opening system configured to put the injection needle in fluidic communication with the container through the piercing needle in which said fluidic path opening system comprises: - a support member on which the drilling needle is mounted, said support member being movable between a first operating position in which the drilling needle is spaced from the drillable septum and the fluidic path is closed, and a second operating position in which the drilling needle has pierced the drillable septum and the fluidic path is open; - an elastic element configured to exert on said support member a pushing action which is appropriate to move the support member from said first operating position to said second operating position; - a drive member that can rotate around an axis of rotation and can move from a first angular position in which the drive member maintains the support member in the first operating position by counteracting the thrust action of the elastic element to a second angular position in which the support member is free to move from the first operating position to the second operating position due to the thrust action of the elastic element.

[0020] The fluidic path opening system of the device of the present invention therefore includes a drive element which, being rotatable, does not require additional space when moved to drive the movement of the drilling needle and the consequent drilling of the perforable septum, thus improving the compactness and ease of use of the device. Furthermore, the rotation of the drive element can be achieved without the need to apply high driving forces.

[0021] Preferred features of the device according to the invention are described below. Each of these features can be provided individually or in combination with the others.

[0022] Preferably, the fluidic pathway comprises a flexible tube having a first end associated with the drilling needle and a second end associated with the injection needle. The flexibility of the tube allows it to be properly housed inside the device, even in small spaces, and allows fluidic communication between the drilling needle and the injection needle to be maintained despite movement of the drilling needle after the opening of the fluidic pathway.

[0023] Preferably, the device includes a motion transmission element configured to activate the movement of the drive element. The opening of the fluidic path is therefore a consequence of a movement of the motion transmission element, which, once displaced, transmits the movement to the drive element and thus to the support element of the drilling needle.

[0024] Preferably, the drive element comprises a first coupling part configured to couple to the motion transmission element and a second coupling part configured to couple to the support member. The transfer of motion from the motion transmission member to the support member of the drilling needle therefore takes place due to a mechanical coupling between the motion transmission member and the drive member and between the drive member and the support member of the drilling needle.

[0025] Preferably, the drive unit comprises a basic body.

[0026] More preferably, the first coupling part and the second coupling part extend on opposite sides from the base body. This allows for the spatial and functional separation of the part of the drive element intended to receive the movement of the motion transmission element from the part intended to impart the movement to the support element, to the benefit of the functionality and structural simplicity of the fluidic path opening system and, consequently, also of the production and purchase cost of the device.

[0027] Preferably, the motion transmission element comprises a rack.

[0028] More preferably, said first coupling part comprises a toothed portion taken with the rack. In this way, the movement of the rack causes a rotation of the drive element.

[0029] In a preferred embodiment of the device of the present invention, said second coupling part comprises a peripheral wall provided with a through opening.

[0030] Preferably, the support member includes a stop element configured to come against an outer surface of said peripheral wall when the drive member is in the first angular position and at the level of said through opening when the drive member is in the second angular position.

[0031] Preferably, the stop element has a size such that it can pass through said through opening.

[0032] The opening of the fluidic system therefore occurs through a structurally simple, yet extremely efficient and responsive, mechanical coupling. During the rotation of the drive member, until the stop element of the drill needle support member remains abutted against the peripheral wall of the drive member, the drill needle remains in a distal position relative to the drillable septum, and the fluidic path remains closed. During the rotation of the drive member, when the through-opening is in a position opposite the stop element, the thrust exerted on the drill needle support member by the elastic element displaces the support member towards the drillable septum until the drill needle pierces the septum, thus opening the fluidic path.

[0033] In certain preferred embodiments, the drive member is movable until it reaches a third angular position in which the drive member prevents the support member from moving from the second operating position to the first operating position. In this way, the support member is prevented from accidentally returning to its first operating position, i.e., from the piercing needle exiting the container during therapy administration, with a consequent undesirable closure of the fluid path. This could occur, for example, if the residual thrust exerted by the elastic element on the support member after the piercing needle has pierced the piercable septum were insufficient to keep the piercing needle inside the container during therapy administration, or in the event of a malfunction or failure of the elastic element.

[0034] Preferably, the peripheral wall delimits in the drive member a zone configured to receive said stop element when the drive member is in the second angular position.

[0035] Preferably, when the drive member is in the third angular position, the stop element is at the level of an inner surface of the peripheral wall. In this condition, the stop element is surrounded by the peripheral wall of the drive member, and any accidental and undesirable movement of the stop element back to its initial position is prevented, which would cause the piercing needle to come out of the container and, consequently, close the fluid path.

[0036] Preferably, said support organ comprises a main body.

[0037] More preferably, said stop element protrudes from said main body.

[0038] In certain embodiments, said elastic element is a torsion spring comprising a plurality of turns arranged around an axis parallel to said axis of rotation.

[0039] In preferred embodiments, the coils of the torsion spring are arranged around an axis orthogonal to said axis of rotation.

[0040] The Applicant assumes that, particularly in these preferred embodiments, the torsion spring can be arranged such that the thrust exerted by the torsion spring on the support member is sufficient to keep the piercing needle inside the container during therapy administration, thus eliminating the need for the means described above to prevent accidental and undesirable return of the support member to its initial operating position. Brief description of the figures

[0041] Other features and advantages of the present invention will become clearer upon reading the following detailed description of preferred embodiments of this, made with reference to the attached drawings and given for illustrative purposes only and not as an exhaustive list. On these drawings:

[0042] [Fig. 1] - [Fig. 1] is a perspective view of a device according to the present invention;

[0043] [Fig.2] - [Fig.2] is an exploded perspective view of a first mode of realization lisation of a module of the device of the [Fig.l];

[0044] [Fig.3] - [Fig.3] is an exploded perspective view of another module of the device in [Fig.1];

[0045] [Fig.4] - [Fig.4] is a perspective view from below of the device in [Fig.1] fitted with a patch;

[0046] [Fig.5] - [Fig.5] is a perspective view from below of the device in [Fig.4] after removing a protective layer from the patch;

[0047] [Fig.6] - [Fig.6] is a top cross-sectional view of the module of [Fig.2] in an initial configuration of the device of [Fig.1];

[0048] [Fig.7] - [Fig.7] is a perspective cross-sectional view of the device of [Fig.1] before being applied to the patient's skin;

[0049] [Fig.8] - [Fig.8] is a perspective cross-sectional view of the device of [Fig.1] just after it has been applied to the patient's skin;

[0050] [Fig.9] - [Fig.9] represents an enlargement of a detail of the module of [Fig.6] in an operating configuration of the device subsequent to that of [Fig.6]

[0051] [Fig.10] - [Fig.10] is a side view in section of part of the module of [Fig.6] in an initial configuration of the device of [Fig.1];

[0052] [Fig. 11] - [Fig. 11] is a side view in section of the part of [Fig. 10] in an operating configuration of the device subsequent to that of [Fig. 10] and corresponding to that of [Fig. 9];

[0053] [Fig. 12] - [Fig. 12] is a side view in section of another detail of the module of [Fig.6] in an initial configuration of the device of [Fig.1];

[0054] [Fig. 13] - [Fig. 13] is a side view in section of the detail of [Fig. 12] in an operating configuration of the device subsequent to that of [Fig. 12] and corresponding to that of figures 9 and 11;

[0055] [Fig. 14] - [Fig. 14] is a perspective cross-sectional view of certain components of the module of [Fig. 6] in an operating configuration of the device subsequent to that of [Fig. 6] and corresponding to that of figures 9, 11 and 13;

[0056] [Fig. 15-16] - Figures 15 and 16 are perspective views of certain components of a second embodiment of the device of the present invention in two subsequent operating configurations thereof;

[0057] [Fig. 17] - [Fig. 17] is a perspective cross-sectional view of some of the components figures 15 and 16 in a device operating configuration subsequent to that of [Fig. 16];

[0058] [Fig. 18-21] - Figures 18 to 21 show an enlargement of another part of the module of [Fig.6] in four later operating configurations of the device of [Fig.1];

[0059] [Fig.22] - [Fig.22] is a cross-sectional side view of part of the device [Fig.1] in a device operating configuration subsequent to that of [Fig.8];

[0060] [Fig. 23] - [Fig. 23] is a side view in cross-section of the device of [Fig. 1] in a possible operating configuration of the device in which said device is not applied to the patient's skin;

[0061] [Fig.24] - [Fig.24] is a perspective view of a component of the device [Fig.l];

[0062] [Fig.25] - [Fig.25] is a perspective view of part of a third mode of realization of the module of [Fig.2] when the device is not applied to the patient's skin;

[0063] [Fig.26] - [Fig.26] is a perspective view of the part of [Fig.25] just after having applied the device to the patient's skin;

[0064] [Fig.27] - [Fig.27] is a top view of part of [Fig.25] in the confi Functioning of the [Fig.26];

[0065] [Fig.28] - [Fig.28] is a perspective view of part of [Fig.25] in a device operating configuration subsequent to that of figures 26 and 27;

[0066] [Fig.29] - [Fig.29] is a top view of part of [Fig.25] in the confi Functioning of the [Fig.28];

[0067] [Fig. 30-32] - Figures 30 to 32 are perspective views of part of the [Fig.25] in three device operating configurations subsequent to that of [Fig.28];

[0068] [Fig.33] - [Fig.33] is a side view in section of part of [Fig.25] in the operating configuration of the [Fig.26];

[0069] [Fig.34] - [Fig.34] is a side view in section of part of [Fig.25] in the operating configuration of the [Fig.32];

[0070] [Fig.35] - [Fig.35] is a time diagram relating to different stages of operation functions implemented by the device of the present invention during its use. Detailed description of the invention

[0071] In [Fig.1], a device of the type that can be worn on oneself for the administration of a drug according to the present invention is indicated by the numerical reference 1.

[0072] The device 1 comprises an administration module 2, shown in [Fig.2], and a control module 3, shown in [Fig.3].

[0073] Device 1 is obtained by mutually coupling the administration module 2 and the control module 3. This coupling is reversible, i.e. the two modules 2 and 3 can be decoupled after having been coupled.

[0074] One or more seals (not shown) are interposed between the administration module 2 and the control module 3 in order to ensure the sealing of the mutual coupling.

[0075] The administration module 2 is preferably disposable, while the control module 3 is preferably reusable. In other words, the administration module 2 is configured to be applied to the patient's body only once and for a specific period of time to administer the drug, completely or partially, in one or more successive injections, even if spaced out over time. Conversely, the control module 3 can be used multiple times by coupling it occasionally with a new administration module 2.

[0076] As shown in [Fig. 3], the control module 3 comprises a lower body 4 and an upper cover 5 attached to the lower body 4, preferably by ultrasonic welding. In this case, ultrasonic welding is preferable to laser welding because the latter requires the use of transparent materials, which are not considered practical for the control module 3, since it can be customized with different colors and / or finishes.

[0077] A housing compartment 6 is defined between the lower body 4 and the upper cover 5. The housing compartment 6 contains a control unit 7, generally consisting of a printed circuit board and configured to control the administration of the drug from the administration module 2, a power supply battery 8 configured to power the control unit 7 and a motor 9 which drives a magnetic drive rotor 9a.

[0078] A plurality of electronic components and a hardware unit that supplies power to said electronic components are provided in the control module 3.

[0079] The control module 3 further includes a switch (not shown) configured to supply power to the control unit 7 and an activation button 3a. The patient activates the device 1 by pressing the activation button 3a.

[0080] As shown in [Fig. 2], the administration module 2 comprises a main body 11 and an intermediate cover 15 associated with the main body 11 and interposed between the main body 11 and the lower body 4 of the control module 3. Preferably, the intermediate cover 15 is welded to the main body 11 by laser welding. In this case, ultrasonic welding is preferable, because the assembly The administration module 2 takes place with all the organs described below already mounted on the main body 11 and the use of ultrasonic welding would risk activating these organs.

[0081] A housing compartment 10 is defined between the main body 11 and the intermediate cover 15.

[0082] As shown in [Fig. 10], the main body 11 includes an application surface 12 configured to come into contact with the patient's body.

[0083] The application surface 12 is substantially flat and defines a plane P to rest on the patient's skin.

[0084] The application surface 12 includes a through opening 12a ([Fig.2]).

[0085] Referring again to [Fig.2], the housing compartment 10 is configured to house a plurality of components, including a cartridge 20 and a fluidic path 30.

[0086] The administration module 2 further includes an ignition magnet 2a and an NFC tag 2b on which a plurality of information is stored.

[0087] The cartridge 20 is disposed on the main body 11 and comprises a substantially cylindrical container 22, made of plastic or glass, containing the medication to be administered to a patient. A pierceable septum 24, which closes the container 22 and ensures its sterility until the device 1 is used, is arranged at one end 23 of the container 22. A piston 26 (shown in [Fig. 6]) can slide within the container 22 to administer the medication.

[0088] As shown in [Fig.6], the fluidic path 30 is also arranged on the main body 11 and is configured to be traversed by the drug during subcutaneous administration of the drug, allowing the transfer of the drug from the cartridge 20 to the patient's body.

[0089] The fluidic path 30 includes a piercing needle 32 configured to pierce the pierceable septum 24 (as illustrated for example in [Fig. 13]), an injection needle 34 configured to be inserted into the patient's body (as illustrated for example in [Fig. 22]), and a flexible tube 36 (illustrated for example in Figures 2 and 6) which puts the needles 32 and 34 mentioned above into fluidic communication.

[0090] In particular, as shown in Figures 2 and 6, the flexible tube 36 has an end portion 36a connected to a support member 42 which supports the piercing needle 32 and an opposite end portion 36b connected to a support member 62 which supports the injection needle 34.

[0091] With reference to [Fig. 6], the administration module 2 further comprises a fluidic path opening system 40 configured to control the piercing of the pierceable septum 24 by the piercing needle 32 and thus put the container 22 in fluidic communication with the injection needle 34 through the piercing needle 32 and the flexible tube 36.

[0092] The support member 42 is slidably mounted on a sliding guide 44 mounted on the main body 11 (Figures 9, 12 and 13). The support member 42 is movable between a first operating position in which the drilling needle 32 is spaced from the drillable septum 24 (as illustrated for example in Figures 10 and 12) and the fluidic path 30 is closed, and a second operating position in which the drilling needle 32 has pierced the drillable septum 24 (as illustrated for example in Figures 11 and 13), thus opening the fluidic path 30.

[0093] With reference to figures 10 and 11, the movement of the support member 42 is achieved by means of a motion transmission member 50 comprising a worm screw 54 in contact with a rack 51 at the level of a coupling part 53 of the rack 51. The latter is in turn coupled to a drive member 48 which can rotate about an axis of rotation X and which can be coupled to the support member 42.

[0094] In particular, the drive member 48 comprises a substantially circular base body 48a, a coupling portion 48b configured to couple to the support member 42, and a coupling portion 48c at which a coupling portion 52 of the rack 51 is engaged. The coupling portion 52 is disposed downstream of the coupling portion 53 along direction A.

[0095] The coupling parts 48b and 48c extend from the base body 48a on sides axially opposite with respect to the axis of rotation X.

[0096] The coupling part 48b is defined by a peripheral wall 48d. The latter is provided with a through opening 48e and delimits in the coupling part 48b a substantially cylindrical zone 48g (figures 11 and 14).

[0097] The coupling part 48c includes a toothing 48f in contact with the coupling part 52 of the rack 51 and extending circumferentially over a predetermined angle less than 360°, more preferably less than 180°, for example equal to about 90°.

[0098] As shown in [Fig. 10], the rack 51 is driven to move towards the support member 42 along a direction A orthogonal to the axis of rotation X and substantially parallel to the plane P, by the rotation of the worm screw 54 which in turn is driven in rotation by a magnetic rotor 56 (shown in full in [Fig. 2]) mounted on the main body 11 and driven by the magnetic drive rotor 9a provided in the control module 3. Due to the coupling between the rack 51 and the teeth 48f, the movement of the rack 51 causes the drive member 48 to rotate around the axis of rotation X.

[0099] As shown in [Fig.9], the support member 42 is subjected to a thrust action along a direction B opposite to the direction A by an elastic element 46, in particular a torsion spring. This spring comprises a plurality of turns arranged around an axis orthogonal to the axis of rotation X and tends to push the support member 42 from the first operating position to the second operating position.

[0100] As shown in Figures 10, 11 and 14, the support member 42 comprises a body 42a and a stop element 43 projecting from the body 42a and dimensioned to pass through the through opening 48e. In particular, the stop element 43 is defined by a cylindrical pin 43a that extends cantilevered from the outer lateral surface of the body 42a.

[0101] Until the drive member 48 rotates around the axis of rotation X by an angle less than a predetermined value, the support member 42 remains in the first operating position due to the mutual stop between the stop element 43 and the outer surface of the peripheral wall 48d. This mutual stop counteracts the thrust action exerted by the elastic element 46 on the support member 42 ([Fig. 10]).

[0102] As soon as the angle of rotation of the drive member 48 reaches the predetermined value mentioned above, the support member 42 is free to move from the first operating position to the second operating position along the direction B because of the fact that the stop element 43 is at the level of the through opening 48e ([Fig. 11]) and can pass through it because of the pushing action exerted by the elastic element 46, so as to arrange itself in the area 48g of the coupling part 48b ([Fig. 14]).

[0103] Figures 15 to 17 depict a second embodiment of the fluidic path opening system 40, which can also be used in the device 1 of the present invention as an alternative to that described above. The elements of this second embodiment that are identical or equivalent to those described above are designated by the same numeral.

[0104] In this second embodiment, the coils of the torsion spring which defines the elastic element 46 are arranged around an axis orthogonal to the axis of rotation X and positioned closer to the rack 51 with respect to the axis of the torsion spring of the embodiment described above.

[0105] Furthermore, in the embodiment of figures 15 to 17, the stop element 43 is defined by a straight rib 43b arranged on the outer lateral surface of the body 42a.

[0106] In [Fig. 15], the drive member 48 is shown in a first angular position, while in [Fig. 16], the drive member 48 is shown in a second angular position. These angular positions are functionally similar to those in Figures 10 and 11 of the first embodiment described above.

[0107] In [Fig. 17], the drive member 48 is shown in a different angular position, posterior to that of [Fig. 16]. When the drive member reaches the angular position of [Fig. 17], the rib 43b, which has previously entered the area 48g of the coupling portion 48b ([Fig. 16]), is located at an inner surface of the peripheral wall 48d and cannot exit the area 48g. In this way, the drive member 48 prevents a possible tendency of the support member 42 to move from the second operating position to the first operating position.

[0108] As shown in [Fig.6] and Figures 18 to 23, the delivery module 2 also includes an injection needle displacement mechanism 60, configured to move the injection needle 34, at the start of therapy administration from a rest position, in which the injection needle 34 is fully arranged inside the device 1 and does not protrude from the plane P of the device 1 (Figures 18 and 19), to an injection position in which the injection needle 34 protrudes at least partially from the plane P of the device 1 (Figures 20 and 22) through the through opening 12a, and at the end of therapy administration from the injection position to the rest position ([Fig.21]).

[0109] The support member 62 which supports the injection needle 34 is movable orthogonally to the plane P between a first operating position in which the injection needle 34 is in the rest position and a second operating position in which the injection needle 34 is in the injection position.

[0110] The support member 62 has a substantially cylindrical shape and has an external lateral surface 62a to which the end part 36b of the flexible tube 36 is connected.

[0111] As shown in [Fig.23], the support member 62 is subjected to a pushing action exerted by a compression spring 64. This pushing action tends to push the support member 62 towards its first operating position, so as to maintain the injection needle 34 in the rest position before the use of the device 1 ([Fig. 18]) and to return the injection needle 34 to the rest position after the administration of the therapy ([Fig.21]).

[0112] In particular, the compression spring 64 is arranged between the main body 11 and an inner surface 62b of the support member 62 facing the plane P.

[0113] The compression spring 64 extends along an axis C orthogonal to the plane P, while the injection needle 34 extends along a distinct axis N parallel to the axis C. The axis N is arranged near the outer lateral surface 62a of the support member 62.

[0114] With reference to Figures 18 to 23, the injection needle displacement mechanism 60 comprises a push member 63 configured to move the support member 62 and, thus, the injection needle 34. The push member 63 can move from a first service position (figures 18 and 19) in which the support member 62 is in the first operating position and the injection needle 34 is in the rest position to a second service position (figures 20, 22 and 23) in which the support member 62 is in the second operating position and the injection needle 34 is in the injection position.

[0115] The thrust member 63 is subjected to a thrust action exerted by a compression spring 65 (Figures 22 and 23). This thrust action tends to push the thrust member 63 towards the second operating position.

[0116] The compression spring 65 is arranged between the intermediate cover 15 and an inner surface 63a of the thrust member 63 facing away from the plane P.

[0117] The compression spring 65 extends along an axis D orthogonal to the plane P. The axis D is distinct from the axis C and the axis N, and parallel to them.

[0118] The compression spring 65 has a higher elastic constant than that of the compression spring 64.

[0119] The injection needle displacement mechanism 60 has two main operating configurations.

[0120] In a first operating configuration, illustrated in [Fig. 20], the thrust member 63 is coupled to the support member 62, and the force exerted by the compression spring 65 on the thrust member 63 moves it from the first operating position to the second operating position, moving the support member 62 from the first operating position to the second operating position. During the movement of the support member 62, the compression spring 64 is loaded.

[0121] In a second operating configuration, shown in [Fig. 21], the thrust member 63 is decoupled from the support member 62, and the force exerted by the compression spring 64 on the support member 62 moves it from the second operating position to the first operating position. When the injection needle displacement mechanism 60 is in the second operating configuration, the thrust member 63, which is decoupled from the support member 62, remains in the second operating position due to the thrust action exerted by the compression spring 65.

[0122] The thrust member 63 has a substantially cylindrical shape and is movable in rotation about the axis D from a first angular position ([Fig.20]) in which the injection needle displacement mechanism 60 is in the first operating configuration to a second angular position ([Fig.21]) in which the injection needle displacement mechanism 60 is in the second operating configuration.

[0123] A stop element 62c (visible in [Fig. 21]) extends from the lateral surface external 62a of the support member 62 towards the thrust member 63 and a thrust element 63c extends from an external lateral surface 63b of the thrust member 63 towards the support member 62.

[0124] When the injection needle displacement mechanism 60 is in the first operating configuration, the push element 63c is coupled to the stop element 62c and exerts a push action against the latter ([Fig.20]), whereas, when the injection needle displacement mechanism 60 is in the second operating configuration, the push element 63c is decoupled from the stop element 62c ([Fig.21]).

[0125] The rotation of the thrust member 63 from the first angular position to the second angular position, and consequently the transition of the injection needle displacement mechanism 60 from the first operating configuration to the second operating configuration, is driven by an instruction member 61 arranged concentrically to and outside the thrust member 63.

[0126] The instruction member 61 has a substantially cylindrical shape and is driven to rotate about the axis D initially from an angular stop position ([Fig.18]) in which the thrust member 63 is in the first angular position and the instruction member 61 is coupled to the thrust member 63 and maintains the latter in the first service position, to a first angular release position ([Fig.20]) in which the thrust member 63 is still in the first angular position and the instruction member 61 is decoupled from the thrust member 63 allowing the thrust member 63 to reach the second service position.

[0127] A projecting element 63d extends from the outer lateral surface 63b of the thrust member 63 on the opposite side with respect to the thrust member 63c.

[0128] The instruction member 61 includes a stop surface 61e which, when the instruction member 61 is in the angular stop position, is abutted against the projecting element 63d (figures 18 and 19).

[0129] The instruction member 61 further includes a seat 61a which, when the instruction member 61 is in the first angular release position, houses the projecting element 63d ([Fig.20]), and a through opening 61b ([Fig.18]) through which the thrust element 63c passes to allow the thrust member 63 to couple to the support member 62.

[0130] When, following the rotation of the instruction member 61, the seat 61a is below the projecting element 63d, the thrust member 63 is free to move from the first operating position to the second operating position due to the thrust action exerted by the compression spring 65. Consequently, the support member 62 is moved from the first operating position to the second operating position due to the movement of the thrust member 63 from the first service position to the second service position and, consequently, of the thrust exerted by the thrust element 63c on the stop element 62c, this thrust no longer being hindered by the stop surface 61e of the instruction member 61. The injection needle 34 is thus extracted from the device 1.

[0131] The thrust element 63c passes through the through opening 61b of the instruction member 61 both when the thrust member 63 is in the first service position and when the thrust member 63 is in the second service position.

[0132] Next, the instruction member 61 is rotated about the axis D from the first angular release position ([Fig. 20]) to a second angular release position ([Fig. 21]) in which the thrust member 63 is in the second angular position. This rotation causes a similar rotation of the thrust member 63 because the protruding element 63d is housed in the seat 61a.

[0133] The housing of the protruding element 63d in the seat 61a therefore allows both the transition of the push member 63 from the first service position to the second service position due to the push exerted on the push member 63 by the compression spring 65, with the consequent extraction of the injection needle 34 from the device 1 ([Fig.20]), and the transfer of the rotary motion of the instruction member 61 to the push member 63 when it is in the second service position ([Fig.21]), with the consequent release of the support member 62 by the push member 63 and the consequent retraction of the injection needle 34 inside the device 1 due to the push exerted on the support member 62 by the compression spring 64.

[0134] The instruction member 61 includes a coupling part 61c in contact with the worm screw 54. The coupling part 61c is a toothing extended circumferentially over a predetermined angle, preferably less than 180°.

[0135] As shown in [Fig.22], a suitably shaped plate 630 is arranged above the thrust member 63 and the support member 62 to prevent rotation of the thrust member 63 around the axis D. This plate 630 also allows all the components of the injection needle displacement mechanism 60 to be aligned and ensures the retention of the compression springs 64 and 65 along the direction of the axis D.

[0136] As shown in Figures 7, 8, 22 to 24, the administration module 2 also includes a protective element 70 disposed around the injection needle 34 and configured to cover the tip of the injection needle 34 if the latter is in the injection position, or moves into it, for example due to a malfunction or failure of the injection needle displacement mechanism 60, before applying the device 1 to the patient's skin, or if the injection needle 34 accidentally remains in the injection position during the removal of device 1 from the patient's skin, for example due to accidental or voluntary removal by the patient before the end of therapy administration ( [Fig.23]).

[0137] The protective element 70 is movable between a first operating position (Figures 7 and 23) in which it protrudes from the device 1 and covers the tip of the injection needle 34 if the injection needle 34 is in the injection position ([Fig.23]), and a second operating position (Figures 8 and 22) in which it does not protrude from the device 1.

[0138] The protective element 70 is shown in detail in [Fig.24].

[0139] The protective element 70 is subjected to a thrust action exerted by a elastic element 72, in particular by a compression spring. This pushing action tends to maintain the protective element 72 in the first operating position both before applying the device 1 to the patient's skin and when the device 1 is removed from the patient's skin ([Fig.7]) and to allow the protective element 70 to reach the second operating position when the device 1 is applied to the patient's skin (figures 8 and 22).

[0140] In particular, the elastic element 72 is arranged between the intermediate cover 15 and an inner surface 70e which is inside the protective element 70 and which is turned towards the intermediate cover 15 (figures 22 and 23).

[0141] The elastic element 72 extends along an axis E orthogonal to the plane P. The axis E is distinct from the axes C, D and N, and parallel to them.

[0142] With reference to [Fig.6], the administration module 2 includes a stop mechanism 170 configured to stop the movement of the protection element 70.

[0143] In particular, the protective element 70 includes a locking element 70b configured to lock the protective element 70 in the first operating position when the device 1 is removed from the patient's skin. The locking of the protective element 70 occurs when the locking element 70b interferes with a stop element 74 associated with the rack 51 at a coupling portion 55 of the rack 51 which is arranged upstream with respect to the coupling portion 52 and downstream with respect to the coupling portion 53 along direction A, i.e. interposed between the coupling portion 53 and the coupling portion 52 (Figures 20 and 21).

[0144] The device 1 has a reversible initial configuration in which the protective element 70 is free to move between the first operating position and the second operating position and vice versa before the device 1 is applied to the patient's skin. In this configuration, the locking element 70b, which is integral with the protective element 70, is in a distal position relative to the stop element 74.

[0145] The device 1 has an irreversible final configuration in which the protective element 70 is locked in the first operating position. In this configuration, the locking element 70b is in contact with the stop element 74.

[0146] Due to the movement of the rack 51 along direction A, the stop element 74 moves along this direction A from an initial position to a final position.

[0147] In the initial position, the stop element 74 and the locking element 70b are not superimposed on each other and the device 1 is in the initial reversible configuration (Figures 18 and 19), while in the final position, the stop element 74 and the locking element 70b are superimposed on each other and the device 1 is in the final irreversible configuration (Figures 20 and 21).

[0148] Preferably, the locking element 70b is made of a rigid material and the stopping element 74 is made of a deformable material.

[0149] The switch from the reversible to the irreversible configuration occurs when the stop element 74 is in the final position and the locking element 70b moves along a direction F ([Fig.23]) orthogonal to the direction A, passing beyond the stop element 74. This movement occurs when the device 1 is removed from the patient's skin due to the movement of the protective element 70 from the second operating position to the first operating position due to the pushing action exerted by the elastic element 72.

[0150] The movement of the locking element 70b along the direction F first causes interference between the locking element 70b and the stop element 74, then the transition of the locking element 70b to the opposite side of the stop element 74 due to the deformation of the latter.

[0151] In particular, the stopping element 74 comprises a first surface turned away from plane P and a second surface turned towards plane P.

[0152] The first surface allows the deformation of the stop element 74 as a consequence of the interference with the locking element 70b and the displacement of the locking element 70b along the direction F from the second operating position to the first operating position.

[0153] The first surface is preferably inclined with respect to a plane orthogonal to the direction F, thus facilitating the transition of the locking element 70b from one side to the other side of the stop element 74 as a consequence of the deformation of the latter.

[0154] The second surface instead defines a notch which, when the device 1 is in its final irreversible configuration, prevents the locking element 70b from moving from its first operating position. The second surface is preferably orthogonal to the direction F.

[0155] As shown in [Fig. 24], the protective element 70 has a base 70a provided of a through hole 71 to allow the transition of the injection needle 34 during the movement of the injection needle 34 between the rest position and the injection position when the protective element 70 is in the second operating position.

[0156] The base 70a includes a raised edge 70b defining in the base 70a a recess 70c which houses the tip of the injection needle 34 both when the protective element 70 is in its second operating position and the injection needle 34 is in the rest position ([Fig.8]) and when the protective element 70 is in its first operating position and the injection needle 34 is in the injection position ([Fig.23]).

[0157] As shown in Figures 33 and 34, the through hole 71 can be closed by a drillable septum 271.

[0158] Device 1 includes a position sensor 76 (Figures 7 and 8) adapted to detect contact of device 1 with the patient's skin.

[0159] The position sensor 76 includes a magnet 77 associated as one with the protective element 70 and a Hall effect sensor 78 disposed in the control module 3 near the magnet 77.

[0160] The magnet 77 is entirely housed in a seat 75 formed in the protective element 70 ([Fig.24]).

[0161] The locking element 70b is associated with the seat 75 near the magnet 77.

[0162] As shown in Figures 2 and 5, the device 1 further comprises a flexible sleeve 80 associated in a watertight manner to the application surface 12 of the administration module 2 around the through opening 12a.

[0163] The flexible sleeve 80 is made of a medical-grade silicone material.

[0164] The flexible sleeve 80 surrounds the protective element 70 and comprises a surface base 80a having an inner surface joined in one piece with the outer surface of base 70a of the protective element 70.

[0165] In the embodiment illustrated here, the flexible sleeve 80 is defined by a bellows-type membrane having a truncated cone shape.

[0166] The flexible sleeve 80 is disposed entirely inside the administration module 2 when the protective element 70 is in its second operating position ([Fig.8]).

[0167] The base surface 80a of the flexible sleeve 80 covers the through hole 71 of the protective element 70 and can be pierced by the injection needle 34 when the injection needle 34 moves from the rest position to the injection position.

[0168] The flexible sleeve 80 includes an annular end portion 83 fixed to the application surface 12 of the delivery module 2 by means of a compression ring 83a (Figures 23, 33 and 34). The latter is welded to the surface application 12 by ultrasonic welding.

[0169] The annular end part 83 is thus interposed between the application surface 12 and the compression ring 83a and prevents water and powders from entering the inside of the device 1 via the through opening 12a of the application surface 12.

[0170] As shown in Figures 4 and 5, a patch 90 is applied to the application surface 12 of the main body 11 of the administration module 2.

[0171] The patch 90 comprises an adhesive layer 91 fixed in one piece to the application surface 12 and a protective layer 92 removably fixed to the adhesive layer 91. Before administering the therapy, the protective layer 92 is removed ([Fig.5]) and the device 1 is fixed to the patient's skin through the adhesive layer 91.

[0172] The device 1 further includes a cap 100 fixed in one piece to the protective layer 92. In particular, the cap 100 includes a collar 101 fixed to the protective layer 92 by interposition of a double adhesive element 101a.

[0173] The cap 100 is made of a rigid material and is shaped to completely house, with some clearance, the protective element 70 and the flexible sleeve 80 which surrounds the protective element 70 when the latter is in its first operating position.

[0174] In the embodiment illustrated here, the cap 100 has a frustoconical shape.

[0175] As already mentioned, the protective element 70 is initially in its extended configuration of [Fig. 5] and the cap 100 covers the protective element 70, as shown in [Fig. 4].

[0176] Before applying the device 1 to the patient's skin, the patient removes the protective layer 92 from the patch 90, simultaneously removing the cap 100 with it and thus exposing the protective element 70 and the adhesive layer 91 of the patch 90.

[0177] The patient can then proceed to apply the device 1 to his skin by fixing it through the adhesive layer 91 of the patch 90. The patient's skin counteracts the pushing action exerted by the elastic element 72 and causes the protective element 70 to retract inside the delivery module 2, bringing the magnet 77 closer to the Hall effect sensor 78 and thus allowing the control unit 7 to establish that the device 1 is in contact with the patient's skin and to activate the administration of the therapy.

[0178] The administration of the therapy comprises the controlled movement of the piston 26 inside the container 22 towards the pierceable septum 24. For this purpose, the administration module 2 includes a drug delivery mechanism 110 ([Fig. 6]) which is activated, driven by the control unit 7, by the same magnetic rotor 56 that drives the motion transmission member 50 and, consequently, the rotation of the worm gear 54. As already mentioned, the latter drives both the activation of the injection needle movement mechanism 60 and the de placement of the rack 51 along direction A, which in turn causes both the opening of the fluidic path 30 and the locking of the protective element 70 in the first operating position after the removal of the device 1 from the patient's skin.

[0179] In particular, the control unit 7 drives the magnetic rotor 56 alternately in a first direction of rotation to activate the motion transmission member 50 and in a second direction of rotation opposite to the first direction of rotation to drive the administration of the drug from the container 22 when another motion transmission member 111 ([Fig.6]) arranged in the main body 11 on the side opposite the motion transmission member 50 to the magnetic rotor 56 and the worm gear 54 is activated.

[0180] Figures 25 to 34 show another embodiment of a device which differs from device 1 described above with respect to certain details relating to the injection needle displacement mechanism 60, the protective element 70 and the flexible sleeve 80. The elements and / or components of this embodiment which are identical or equivalent to those described above are indicated by the same numerical reference.

[0181] In this case, the flexible sleeve 80 does not have the base surface 80a and the protective element 70 has a base 70a having a diameter greater than that of the adjacent end part of the flexible sleeve 80.

[0182] Also in this case, a support member 62 which supports the injection needle, a push member 63 and an instruction member 61 equivalent to those described above are provided.

[0183] Fig. 25 shows the operating configuration in which the injection needle 34 is in the rest position and the protective element 70 and the flexible sleeve 80 protrude from the device.

[0184] Figures 26 and 33 show the operating configuration in which the device is applied to the patient's skin. The injection needle 34 is always in the resting position, and the protective element 70 and the flexible sleeve 80 are pushed inside the device. Only the base 70a of the protective element 70 remains protruding from the device.

[0185] Figure 28 shows the operating configuration in which the device is applied to the patient's skin and the injection needle 34 is in the injection position to administer the therapy. The protective element 70 and the flexible sleeve 80 are always inside the device.

[0186] Fig. 30 shows the operating configuration in which the device is still applied to the patient's skin, but the injection needle 34 has been returned to the resting position.

[0187] Figure 31 shows the operating configuration in which the device is removed from the patient's skin at the end of therapy administration. The protective element 70 and the flexible sleeve 80 protrude from the device.

[0188] Figures 32 and 34 show the operating configuration in which the device is removed from the patient's skin before the end of therapy administration and the injection needle 34 is still in the injection position. The protective element 70 and the flexible sleeve 80 protrude from the device, and the protective element 70 is locked in position outside the device.

[0189] In this embodiment, the instruction member 61 comprises two articulated arms 631 arranged on opposite sides with respect to the thrust element 63c ([Fig. 27]). As illustrated in [Fig. 29], each articulated arm 631 comprises a first lever 631a articulated on the outer lateral surface 61g of the instruction member 61 and a second lever 631b articulated on the first lever 631a. Each second lever 631b is slidably coupled to a respective guide 633 and comprises a respective stop element 174 whose shape and material are similar to those of the stop element 74 described previously.

[0190] The protection element 70 comprises two locking elements 171 arranged on diametrically opposite sides with respect to the stop element 62c and configured to cooperate with the stop elements 174 ([Fig.27]).

[0191] During the rotation of the instruction member 61, the stop elements 174 approach the respective locking elements 171 until each of them is at the level of the respective locking element 171.

[0192] In the operating configuration of figures 25 to 30, the two locking elements 171 are arranged on one side relative to the stopping elements 174, in particular near the shaped plate 630. This is because the protective element 70 does not protrude from the device.

[0193] When the protective element 70 is removed from the device following its removal from the patient's skin, the locking elements 171 pass beyond the stop elements 174, locking the protective element 70 in the position shown in [Fig. 31]. In this operating configuration, the injection needle 34 has been previously retracted into the device.

[0194] If, after removal of the device from the patient's skin, the injection needle 34 remains outside the device, as in the operating configuration of [Fig.32], the protective element 70 and the flexible sleeve 80 protect the patient from any contact with the injection needle 34.

[0195] With reference also to [Fig.35], the sequence of operating steps implemented by device 1 during its use is described in detail below.

[0196] During a first time interval preceding the instant tO when the patient activates the Device 1, by pressing the activation button 3a, allows the patient to separately receive the administration module 2 and the control module 3 and pair them. During this time interval, Device 1 is in standby mode; that is, the power supply battery 8 powers only some of the electronic components in the control module 3. This is achieved through a hardware unit that cuts off the power supply to all electronic components except those associated with: the ignition magnet 2a, the switch that powers the control unit 7, the activation button 3a for activating Device 1, and the NFC tag 2b. The motor 9 is not powered.

[0197] After mutual coupling, the administration module 2 and the control module 3 are temporarily coupled not only mechanically but also magnetically by means of a coupling established by the proximity between the magnetic drive rotor 9a provided in the control module 3 and the magnetic rotor 56 provided in the administration module 2. The control unit 7 is energized by a change in the magnetic field generated by the mutual approach between the ignition magnet 2a and the switch that powers the control unit 7, which are closer together. This mutual approach triggers the aforementioned switch, which energizes the control unit 7.

[0198] Once powered on, the control unit 7 performs a self-diagnostic.

[0199] Furthermore, after power-up, the control unit 7 queries the NFC tag 2b by reading the information stored therein. In particular, the control unit 7 performs any or all of the following actions: checking whether the administration module 2 has already been used, checking whether the administration module 2 is configured to administer a correct dosage of the drug, establishing the drug administration procedure, establishing the drug administration rate.

[0200] After power-up, the control unit 7 also reads the signal from the position sensor 76 to determine if the device 1 is in contact with the patient's skin.

[0201] In particular, the patient removes the protective layer 92 from the patch 90, simultaneously removing the cap 100 with it, and applies the device 1 to his skin.

[0202] In the time interval mentioned above preceding time t0 and before the application of device 1 to the patient's skin: - the fluidic path 30 is closed, that is to say that the drilling needle 32 is in a distal position relative to the perforatable septum 24 and the elastic element 46 is compressed; - the protective element 70 is in its first operating position, i.e. it protrudes from the device 1 and the elastic element 72 is extended ; - due to the distance between the magnet 77 and the Hall effect sensor 78, the position sensor 76 signals to the control unit 7 that the device 1 has not yet been applied to the patient's body; - the injection needle displacement mechanism 60 is deactivated, i.e. the injection needle 34 is in the rest position, inside the device 1; - the flexible sleeve 80 is extended.

[0203] In the time interval mentioned above preceding time t0, after application of device 1 to the patient's skin: - the fluidic path 30 remains closed; - the protective element 70 is in its second operating position, i.e. it is arranged inside the device 1 and the elastic element 72 is compressed; - due to the mutual approach between the magnet 77 and the Hall effect sensor 78, the position sensor 76 signals to the control unit 7 that the device has been applied to the patient's body and that the control unit 7 can be activated for the administration of the therapy; - the injection needle displacement mechanism 60 remains deactivated; - the flexible sleeve 80 is folded inside the device 1.

[0204] If the control unit 7 does not detect the signal from the position sensor 76 within a predetermined time, the control unit 7 switches off and the device 1 returns to standby mode.

[0205] At this stage (i.e. at time t0), the device 1 is put into operation by the patient by pressing the activation button 3a. The motor 9 is activated and the control unit 7 orders a series of operations which require no action on the part of the patient.

[0206] In a time interval tl following the time t0 and which lasts for example 10 to 15 seconds, the magnetic rotor 56 is set in rotation in the first direction of rotation by the motor 9 and activates the motion transmission member 50, which in turn simultaneously activates the fluidic path opening system 40 (the drilling needle 32 pierces the pierceable septum 24 and the elastic element 46 extends) and the injection needle displacement mechanism 60 without however moving the injection needle 24, which remains in the rest position.

[0207] In particular, the rotation of the worm gear 54 causes the rack 51 to move along direction A and the consequent rotation of the drive member 48 and the opening of the fluidic path 30. This rotation also causes the instruction member 61 to rotate, moving from the angular stopping position of [Fig. 18] to another angular stopping position, shown in the [Fig.19]. This rotation does not cause any rotation of the thrust member 63, which remains in the first service position because the projecting element 63d remains against the abutment surface 61e.

[0208] In a time interval t2 following the time interval t1 and lasting for example 8 to 12 seconds, the magnetic rotor 56 is set in rotation in the second direction of rotation by the motor 9 and activates the motion transmission member 111, causing the piston 26 to move inside the container 22. Such a movement causes the drug to exit through the piercing needle 32, but not the drug to be administered through the injection needle 34. The thrust exerted by the piston 26 on the drug forces out the air contained in the fluidic path 30 (priming phase).

[0209] In a time interval t3 following the time interval t2 and lasting for example 8 to 12 seconds, the magnetic rotor 56 is put back into rotation in the first direction of rotation by the motor 9 and again activates the motion transmission member 50, causing the reactivation of the injection needle displacement mechanism 60.

[0210] In particular, the rotation of the worm gear 54 causes an additional rotation of the instruction member 61, which moves from the angular stop position of [Fig. 19] to the first angular release position of [Fig. 20]. This rotation causes the thrust member 63 to move from the first operating position to the second operating position and, consequently, the support member 62 (and therefore the injection needle 34) to move from the first operating position (injection needle 34 in the rest position) to the second operating position (injection needle 34 in the injection position). The injection needle 34 thus penetrates the patient's skin.

[0211] In a time interval t4 following the time interval t3 and lasting for example 2 to 5 seconds, the magnetic rotor 56 is again set in rotation in the second direction of rotation by the motor 9 and again activates the motion transmission member 111, causing the movement of the piston 26 inside the container 22 which this time causes the administration of the drug into the patient's body through the injection needle 34. In this phase, it may still happen that a very limited quantity of air, which remained inside the fluidic path 30 after the priming phase, is expelled from the fluidic path.

[0212] Following the time interval t4, the motor 9 again drives the magnetic rotor 56 in the first direction of rotation by reactivating the motion transmission member 50 and causing the reactivation of the injection needle displacement mechanism 60.

[0213] In particular, the rotation of the worm screw 54 causes an additional rotation of the instruction member 61, which moves from the first angular release position of [Fig. 20] to the second angular release position of [Fig. 21]. This rotation causes a similar rotation of the thrust member 63 because the protruding element 63d is housed in the seat 61a, and consequently, the thrust member 63c is decoupled from the stop element 62c. At this point, the force exerted by the compression spring 64 on the support member 62 moves it from the second operating position to the first operating position, leaving the thrust member 63 in the second operating position. The injection needle 34 thus returns to its rest position, i.e., inside the device 1.

[0214] The control unit 7 emits an end-of-therapy signal n seconds after causing the instruction organ 61 to move from the first angular release position of [Fig.20] to the second angular release position of [Fig.21], in order to ensure that the patient can remove the device from their skin when the injection needle 34 has returned to the resting position, i.e., it is inside the device 1.

[0215] The emission of the end-of-therapy signal by the control unit is communicated to the patient by visual and / or acoustic signals.

[0216] The patient can then remove device 1 from their skin.

[0217] Removing the device 1 from the patient's body causes the protective element 70 (and consequently the flexible sleeve 80) to move from the second operating position (protective element 70 inside the device 1 and the flexible sleeve 80 folded inside the device 1) to the first operating position (protective element 70 outside the device 1 and the flexible sleeve 80 extended outside the device 1) due to the pressure exerted on the protective element 70 by the elastic element 72 and, consequently, the locking of the protective element 70 in the first operating position due to the movement of the locking element(s) 70b, 171 from one side to the other side of the stop element(s) 74, 174 and the stop between the locking element(s) 70b, 171 and the second surface of the stop element 74, 174 facing plan P.

Claims

Claims

1. Device (1) for subcutaneous administration of a drug, comprising: - an injection needle (34) configured to receive the medicament from a cartridge (20) through a flexible tube (36) and to inject the medicament into a patient; - an injection needle moving mechanism (60) configured to move the injection needle (34) between a rest position in which the injection needle (34) is fully disposed within the device (1) and an injection position in which the injection needle (34) protrudes at least partially from the device (1) wherein said injection needle moving mechanism (60) comprises: - a pushing member (63) movable from a first service position in which the injection needle (34) is in said rest position to a second service position in which the injection needle (34) is in said injection position; - a first compression spring (65) associated with said thrust member (63) and configured to exert on the thrust member (63) a force which is suitable for moving the thrust member (63) from said first service position to said second service position, said first compression spring (65) extending along a first axis (D); - a support member (62) on which the injection needle (34) is mounted, said support member (62) being movable between a first operating position in which the injection needle (34) is in said rest position and a second operating position in which the injection needle (34) is in said injection position, the support member (62) comprising, on an outer lateral surface (62a) thereof, a coupling portion coupled to said flexible tube (36); - a second compression spring (64) associated with an inner surface (62b) of said support member (62) and configured to exert on said support member (62) a force which is suitable for moving said support member (62) from said second operating position to said first operating position, said second compression spring- pressure (64) extending along a second axis (C) which is distinct from said first axis (D); wherein the injection needle moving mechanism (60) has a first operating configuration in which the pushing member (63) is coupled to the support member (62) and the force exerted by the first compression spring (65) on the pushing member (63) moves the pushing member (63) from the first operating position to the second operating position and the support member (62) from the first operating position to the second operating position by loading the second compression spring (64), and a second operating configuration in which the pushing member (63) is decoupled from the support member (62) and the force exerted by the second compression spring (64) on the support member (62) moves the support member (62) from the second operating position to the first operating position.

2. Device (1) according to claim 1, wherein when the injection needle moving mechanism (60) is in the second operating configuration, the pushing member (63) is in the second service position.

3. Device (1) according to claim 1 or 2, wherein said first compression spring (65) has a greater elastic constant than that of said second compression spring (64).

4. Device (1) according to any one of the preceding claims, wherein the pushing member (63) is movable about said first axis (D) from a first angular position in which the injection needle moving mechanism (60) is in the first operating configuration to a second angular position in which the injection needle moving mechanism (60) is in the second operating configuration.

5. Device (1) according to claim 4, wherein the support member (62) comprises a stop element (62c) and the pushing member (63) comprises a pushing element (63c) which, when the injection needle moving mechanism (60) is in the first operating configuration, exerts a pushing action against said stop element (62c).

6. A device (1) according to claim 5, wherein the stop member (62c) projects from the outer side surface (62a) of the support member (62) toward the thrust member (63) and the thrust member (63c) protrudes from an outer side surface (63b) of the thrust member (63) toward the support member (62).

7. Device (1) according to any one of claims 4 to 6, wherein the injection needle moving mechanism (60) comprises an instruction member (61) configured to move the pushing member (63) from said first angular position to said second angular position.

8. Device (1) according to claim 7, wherein the instruction member (61) is movable about said first axis (D) from an angular stop position in which the pushing member (63) is in the first angular position and the instruction member (61) is coupled to the pushing member (63) and maintains the pushing member (63) in the first service position, to a first angular release position in which the pushing member (63) is in the first angular position and the instruction member (61) is decoupled from the pushing member (63) allowing the pushing member (63) to reach the second service position.

9. Device (1) according to claim 8, wherein the pushing member (63) comprises a projecting element (63d) and wherein the instruction member (61) comprises: - a stop surface (61a) configured to abut against said projecting element (63d) when the instruction member (61) is in the angular stop position; - a seat (61a) configured to house said projecting element (63d) when the instruction member (61) is in the first angular release position.

10. Device (1) according to claim 8 or 9, wherein the instruction member (61) is movable about said first axis (D) from said first angular release position to a second angular release position in which the pushing member (63) is in the second angular position.

11. Device (1) according to claim 10 when dependent on claim 9, wherein, when the instruction member (61) is in the second angular release position, said projecting element (63d) is housed in said seat (61a).

12. Device (1) according to any one of the preceding claims, comprising a motion transmission member (50) configured to activate the transition of the needle movement mechanism injection (60) from the first operating configuration to the second operating configuration.

13. A device (1) according to claim 12 when dependent on any one of claims 7 to 11, wherein said instruction member (61) comprises a coupling portion (61c) coupled to said motion transmission member (50).

14. Device (1) according to claim 12 or 13, wherein said motion transmission member (50) comprises a rack (51) - worm screw (54) coupling and wherein said instruction member (61) comprises a toothing engaged with said worm screw (54).

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