SUBCUTANEOUS DRUG ADMINISTRATION DEVICE

Abstract

The invention relates to a subcutaneous drug delivery device, comprising a delivery module (2) including a base wall (12) having a substantially flat outer surface configured to be applied to the skin of a patient, an elongated seat (50) disposed inside the delivery module (2) and extending along a longitudinal direction (L), the elongated seat (50) including at least one resting portion (52), a cartridge (20) disposed in the elongated seat (50) and including a container (22) containing the drug, an elongated opening (13) formed on the base wall (12) at the level of the elongated seat (50) and configured to permit insertion of the cartridge (20) into the elongated seat (50) along an insertion direction (C) orthogonal to the outer surface of the base wall (12), retaining members (54) configured to interact with the cartridge (20) along a retaining direction (T). Figure for the abridged version: 5

Description

Title of the invention: DEVICE FOR SUBCUTANEOUS ADMINISTRATION OF A MEDICINE 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 particularly, to a device of the type that can be worn on oneself, that is to say configured to be applied to the body of a patient in order to allow the subcutaneous administration of a predetermined dose of medication. The application of the device to the patient's body is carried out by a user, for example a doctor or a nurse or the patient. Technical background

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

[0004] In all wearable delivery devices, the drug is initially contained in a cartridge housed within the device and is transferred into the patient's body via a fluid path.

[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 administration device and comprising, at an end thereof opposite the first end mentioned above, an injection needle intended to be inserted into the patient's body to allow the transfer of the medicament from the cartridge to the patient's body.

[0006] Typically, the cartridge comprises a cylindrical container, made of a plastic or glass material, a plunger slidable within the container to push the medicament out of the container and a pierceable septum which ensures the sterility of the container until the administration of the therapy begins.

[0007] The fluid path includes a piercing needle configured to pierce the pierceable septum of the cartridge, the injection needle, and a flexible tube that places the piercing needle in fluid 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 fluid path, allowing the medication 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 plunger on the medication inside the container.

[0009] In all subcutaneous administration devices, the cartridge is housed in a housing provided for this purpose in the device.

[0010] The Applicant noted that prior art subcutaneous drug delivery devices adopt different solutions for inserting the cartridge into the housing seat.

[0011] For example, in the devices described in US 20220031940A1 and US 8157769B2, the cartridge is inserted by the patient into the respective housing seat before using the device by sliding the cartridge along a direction parallel or coincident with the extension direction of the housing seat.

[0012] Alternatively, in the device described in US 10251995B2, the cartridge is first inserted by the patient into the housing seat along an insertion direction that is oblique to the direction along which a cartridge housing holder located inside the device extends. Subsequently, the cartridge is rotated so as to deposit it on the housing holder.

[0013] Still differently, in the device described in US 10307529B2, the insertion of the cartridge into the housing seat by the patient takes place along a direction perpendicular to the direction of extension of the housing seat.

[0014] The Applicant felt the need to control the cost of subcutaneous drug delivery devices as much as possible and considered that this need could be met by speeding up and simplifying the procedure for inserting the cartridge into the respective housing seat.

[0015] The Applicant assumed that, in order to achieve this acceleration and simplification, it is preferable that the cartridge is inserted into the respective housing seat along a direction perpendicular to the longitudinal direction of the housing seat, as described in US 10307529B2. This insertion method is in fact adapted to be easily automated.

[0016] However, the Applicant considered that after placing the cartridge in the housing seat, the cartridge must be locked in a predetermined position (hereinafter also referred to as the nominal position), this position being that which is suitable to ensure the correct alignment of the cartridge with the piercing needle before and during the step of piercing the pierceable septum. Furthermore, in cases where the cartridge is placed in the housing seat during mounting or assembly of the device, the correct alignment between the cartridge and the piercing needle must also be maintained during packaging, transportation, storage and use of the device, and also after shocks, vibrations or drops of the device. It is also necessary to maintain the correct alignment between the cartridge and the piercing needle, even in cases where the device is subjected to temperature variations during storage and transport, since these temperature variations could cause changes in the sizes of the device components and the volumes of the medications.

[0017] The Applicant has observed that, in the device described in US 10307529B2, the locking in position of the cartridge in the housing seat takes place due to the thrust exerted by a closing door of the housing seat on a locking element keyed in the center of the cartridge container or at an end portion of the cartridge container. This thrust causes the locking element (and thus the cartridge) to press against a hydraulic drive unit provided inside the device on the side opposite the closing door with respect to the cartridge, achieving a form-fitting between grooves and projections provided in the locking element and grooves and projections provided in the hydraulic drive unit. Such a form-fitting prevents any movement of the cartridge inside the housing seat.

[0018] The Applicant noted that the solution described in US 10307529B2 for locking the cartridge in position inside the housing seat is cumbersome. This solution actually requires keying the above-mentioned locking element onto the cartridge container. This inevitably causes an increase in the thickness of the device, with the consequence of making it uncomfortable when worn by the patient.

[0019] Another disadvantage related to the provision of the locking element is that it complicates the mechanical structure of the cartridge and makes it compatible only with a specific device.

[0020] Furthermore, the provision of the locking element requires the implementation of an additional process step which could lead to certain disadvantages. For example, in the case where the locking element is mounted on the cartridge by the cartridge manufacturer, it is necessary to verify that such mounting is compatible with the subsequent procedures of sterilization and filling of the cartridge. On the other hand, in cases where the locking element is mounted on the cartridge after filling the cartridge with the medicament, it is necessary to verify that this mounting is compatible with the presence of the medicament inside the cartridge, since, for example, not all medicaments can be subjected to temperature variations or exposed to light.

[0021] The Applicant therefore considered it appropriate to provide a device which, like that described in US 10307529B2, allows the cartridge to be inserted into the housing seat. along a direction perpendicular to the longitudinal direction of the housing seat, so as to accelerate and simplify the procedure for inserting the cartridge into the housing seat and consequently control the production cost and the selling cost of the device, and in which, however, the locking in position of the cartridge inside the housing seat is obtained by a constructively simpler and less tedious solution than that described in US 10307529B2, so as to control the thickness of the device and not suffer from the drawbacks described above.

[0022] The Applicant perceived that a simple and effective way to achieve the above objective is to first provide that the cartridge simply rests inside the housing seat without regard to whether the desired alignment between the cartridge and the piercing needle is achieved and, subsequently, to interact with the cartridge along the longitudinal direction of the cartridge and the housing seat to achieve the desired alignment between the cartridge and the piercing needle. Summary of the invention

[0023] The present invention therefore relates to a device for subcutaneous administration of a drug, comprising: - a dispensing module comprising a base wall having a substantially flat outer surface configured to be applied to the skin of a patient; - an elongated seat arranged inside the distribution module and extending along a longitudinal direction, the elongated seat comprising at least one resting portion; - a cartridge disposed in the elongated seat and comprising a container containing the medication; - an elongated opening formed on the base wall at the elongated seat and configured to allow insertion of the cartridge into the elongated seat along an insertion direction orthogonal to the outer surface of the base wall; - retaining members configured to interact with the cartridge along a retaining direction parallel or coincident with said longitudinal direction and to lock the cartridge inside the elongate seat in a predetermined position; wherein the device has an initial configuration in which the retaining members do not act on the cartridge along the retaining direction and the cartridge rests on said at least one resting portion and is movable in the elongate seat along said longitudinal direction, and a final configuration in which the retaining members interact with the cartridge along the retaining direction and lock the cartridge in said predetermined position.

[0024] In the device of the invention, the cartridge is inserted into the respective seat along a direction perpendicular to the longitudinal direction of the seat itself. This makes it possible to speed up and simplify the procedure for inserting the cartridge into the housing seat, benefiting the production cost and the selling cost of the device. Locking the cartridge in the desired position inside the housing seat takes place instead by providing retaining members which, by acting on the cartridge along the longitudinal direction of the cartridge and the housing seat, do not cause an increase in the thickness of the device.

[0025] Furthermore, the solution adopted by the Applicant, by not providing for any mounting of any additional element on the cartridge and, consequently, by not requiring any additional process step, is constructively simple and free from the drawbacks mentioned above with reference to the technical context.

[0026] The Applicant also provides for the manufacture of another device for subcutaneous administration of a drug which preferably comprises only retaining members of the type described above. This device comprises a plunger slidably mounted inside the container, a piston comprising a rod and a disc which is configured to push the plunger, and a helical spring associated with the piston rod.

[0027] The above-mentioned device does not fall within the scope of protection provided by the claims listed below.

[0028] Preferred features of the two above-mentioned devices are described below. Each of these features may be provided individually, or in combination with the others.

[0029] Preferably, when the device is in the final configuration, the cartridge does not rest on said at least one resting portion. The locking in position of the cartridge inside the elongated seat when the cartridge has reached its nominal position therefore takes place solely due to an action exerted on the cartridge along the longitudinal direction of the elongated seat, i.e. without considering any interaction with the lateral surface of the cartridge.

[0030] Preferably, the resting portion has a cradle shape. This opportunity allows both easy positioning of the cartridge in the respective seat before the cartridge is locked in position, and effective support of the cartridge as it moves within the elongated seat before reaching its nominal position.

[0031] Preferably, the retaining members comprise a support element arranged at a first end portion of the elongate seat.

[0032] Preferably, the support member supports the cartridge when the device is in the initial configuration and when the device is in the final configuration.

[0033] Preferably, the retaining members comprise a thrust element which, when the device is in the initial configuration, is arranged at a second end portion of the elongate seat.

[0034] Preferably, the pushing element is movable towards the support element to move the device from the initial configuration to the final configuration. When the device is in the final configuration, the cartridge has reached its nominal position and remains locked in this position by the action exerted simultaneously by the support element and by the pushing element at the opposite end portions of the cartridge.

[0035] Preferably, the resting portion is arranged near the second end portion of the elongated seat.

[0036] Preferably, the cartridge container comprises an end portion proximal to the support member.

[0037] Preferably, the support member comprises a resting member configured to support the end portion of the container when the device is in the initial configuration. This resting member cooperates with the resting portion provided in the elongate seat to effectively support the cartridge in the elongate seat at the opposite end portions thereof.

[0038] Preferably, the resting element has a cradle shape. As already mentioned with reference to the resting portion, this opportunity allows both easy positioning of the cartridge in the elongated seat before the cartridge is locked in position, and effective support of the cartridge as it moves within the elongated seat before the device reaches the final configuration.

[0039] Preferably, the support element comprises a stop surface which, when the device is in the initial configuration, is in a distal position relative to said end portion and which, when the device is in the final configuration, is in abutment against said end portion. The thrust exerted by the thrust element on the cartridge thus brings the cartridge into abutment against the aforementioned stop surface, reaching its nominal position. When the device is in the final configuration, the cartridge is locked in this nominal position by the pushing action exerted on the cartridge by the thrust element and by the abutment of the cartridge on the abutment surface provided on the rest element.

[0040] Preferably, the cartridge comprises a plunger disposed in a sealed manner inside the container.

[0041] Preferably, the thrust element comprises a piston configured to exert thrust on the plunger.

[0042] Preferably, before reaching the final configuration, the thrust of the piston on the plunger causes a movement of the cartridge towards the support element.

[0043] Preferably, after reaching the final configuration, pushing the piston on the plunger causes the plunger to slide inside the container and the medicament to flow from the container through a piercing needle.

[0044] Therefore, both the transition of the device from the initial configuration to the final configuration (and thus the positioning of the cartridge in its nominal position) and the delivery of the medicament from the container to the patient are a consequence of the pushing action exerted by the piston on the plunger. This pushing action first causes the cartridge to move in the elongated seat until the cartridge is locked in position inside the elongated seat, without any sliding of the plunger inside the container, and only later does it cause the plunger to slide inside the container and the delivery of the medicament to the patient.Locking the cartridge in its nominal position therefore does not require any elements other than those typically provided inside the device to allow its normal use, with consequent control of the overall dimensions of the device and a simplification of production and assembly operations.

[0045] Preferably, the container comprises a main part and a neck having a reduced section interposed between the main part and the end part.

[0046] Preferably, when the device is in the initial configuration, the neck rests on the resting element.

[0047] Preferably, when the device is in the initial configuration, the main part rests on said at least one resting part.

[0048] Preferably, when the device is in the final configuration, the neck does not rest on the resting element.

[0049] Preferably, the device comprises a closing door configured to close the elongated opening.

[0050] Preferably, the closing door is transparent. This opportunity allows both to see the cartridge and the medication it contains, since the cartridges are also typically made of a transparent material, and to automate the procedure for controlling the correct positioning of the cartridge inside the device during the transition from the initial configuration of the device to the final configuration of the device (also called herein the presetting step), thus reducing the production times of the device. In fact, the presetting step provides for the continuous monitoring, by an optical inspection system, of the relative position of the plunger and the piston during the movement of the piston and the interruption of the movement of the piston when the cartridge has reached its nominal position.

[0051] Preferably, the closing door is welded to the distribution module, so as to make the device tamper-proof.

[0052] More preferably, the closing door is welded to the distribution module by laser welding. This type of attachment is possible because the closing door is transparent.

[0053] Preferably, the closing door comprises, on a surface thereof facing the elongated seat, a perimeter rib projecting towards the elongated seat.

[0054] Preferably, the perimeter rib has a shape complementary to that of the profile of the cartridge.

[0055] Preferably, the perimeter rib has a continuous profile.

[0056] Preferably, the perimeter rib does not come into contact with the cartridge. when the device is in the initial configuration.

[0057] Preferably, the perimeter rib does not come into contact with the cartridge when the device is in the final configuration. In this way, the cartridge is free to move within the elongated seat during the pre-setting step. At the same time, the perimeter rib acts as a resting surface for the cartridge in the event of impacts and / or drops of the device, ensures that the cartridge is not damaged during the packaging and transport steps, and prevents unwanted excessive displacements of the cartridge from its nominal position.

[0058] Preferably, the closing door comprises, on its surface facing the elongated seat, a plurality of reinforcing ribs configured to reinforce the perimeter rib.

[0059] Preferably, the reinforcing ribs extend from an outer side surface of the perimeter rib, so as not to obstruct the view of the cartridge from outside the device, which is necessary during the presetting step.

[0060] Preferably, the dispensing module comprises an interface wall disposed on the side opposite the base wall relative to the cartridge.

[0061] Preferably, the device comprises a control module reversibly coupled to the distribution module and configured to house at least one control unit and a battery for powering said control unit.

[0062] Preferably, the control module comprises an interface surface facing the interface wall.

[0063] Preferably, the interface wall comprises an inspection window that allows inspection of the medicament present inside the cartridge before starting the administration of the medicament, and in particular before mutually coupling the dispensing module and the control module. In fact, it is advisable that the dispensing module is only coupled to the control module after having verified, by visual inspection, that the medicament present inside the cartridge does not have an altered appearance. It is also advisable to avoid that the user has the possibility any access to the inspection window after the delivery device is coupled to the patient's body and before the end of therapy delivery. The inspection window is actually only accessible before coupling the delivery module and the control module together. In order to have access to the inspection window after coupling the two modules, it is necessary to uncouple them, which operation is obviously carried out only at the end of therapy delivery.

[0064] Preferably, the cartridge is interposed between the inspection window and the closing door of the elongated opening. In this way, light entering the dispensing module through the transparent closing door can reach the inspection window, facilitating visual inspection of the medicament through the inspection window. The presence of the cartridge between the inspection window and the closing door on the other hand does not prevent the above-mentioned light from reaching the inspection window since the cartridge is made of a transparent material (and is therefore permeable to light) to allow the medicament it contains to be seen and the presetting step to be carried out.

[0065] Preferably, the elongated seat is arranged near a continuous side wall of the dispensing module.

[0066] Preferably, the elongated seat is delimited, along the insertion direction, by the closing door of the elongated opening and by a lower surface arranged on the side opposite the elongated opening relative to the cartridge.

[0067] Preferably, the elongated seat is delimited, along a direction orthogonal to the insertion direction and to the longitudinal direction, by the continuous side wall of the distribution module.

[0068] Preferably, the elongated seat is delimited, along a direction orthogonal to the insertion direction and to the longitudinal direction, by at least one inner side wall arranged on the side opposite the continuous side wall relative to the cartridge. This inner side wall has the sole purpose of avoiding any undesirable interactions between the cartridge and the functional components specifically provided in the device to enable the administration of the medicament to the patient. Therefore, the aforementioned inner side wall does not perform any function when positioning the cartridge inside the elongated seat and while the nominal position of the cartridge is reached.

[0069] The elongated seat is therefore delimited by walls and components necessary for the operation of the device, possibly with the exception of the interior side wall mentioned above, with consequent control of the overall dimensions of the device and a simplification of the production and assembly operations.

[0070] Preferably, the device comprises a coil spring associated with the piston rod. This coil spring acts as a flexible rod of the piston and allows the piston and therefore the cartridge to advance during the presetting step and the plunger to advance inside the cartridge container during the drug delivery step.

[0071] Preferably, the coil spring comprises a plurality of first turns having a first inner diameter and, at a first free end of the coil spring, a plurality of second turns associated with the piston rod and having an inner diameter smaller than that of the first turns. This latter opportunity makes it possible to facilitate and improve the coupling between the coil spring and the piston. The piston in turn prevents direct interaction of the coil spring with the plunger, thus avoiding possible damage to the plunger. In addition, the piston allows the thrust generated by the advancement of the coil spring to be distributed over the entire surface of the plunger, thus allowing easy advancement of the plunger inside the container of the cartridge. Furthermore, the piston guarantees sealing inside the container and correct coupling with the coil spring after mounting the device and before the pre-setting step.After this step, in fact, the thrust exerted by the coil spring would tend in any case to guarantee the correct mutual coupling between the coil spring and the piston, regardless of the correct coupling between the second turns of the coil spring and the piston rod.

[0072] Preferably, some of the first turns are rotatably coupled to an internal thread of a nut. The first turns thus act as a threaded connection for the internal thread of the nut. When the nut is turned, the coil spring moves relative to the nut and pushes the piston against the plunger, pushing the cartridge when the device is in the initial configuration and the medicament after the device has reached the final configuration.

[0073] The choice of providing for the second turns an internal diameter smaller than that of the first turns makes it possible to prevent the coupling between the helical spring and the piston from blocking the rotation of the nut due to the increase in volume of the helical spring at the piston.

[0074] Preferably, the nut has a circular outer profile.

[0075] Preferably, said outer profile is a toothed profile. The rotation of the nut is thus driven by a gear connected to a motor which is configured to activate the device.

[0076] Preferably, the piston rod has an outside diameter smaller than the inside diameter of the second turns.

[0077] Preferably, the piston rod comprises, on an outer lateral surface thereof, a plurality of longitudinal ribs coupled by interference to the second turns.

[0078] Preferably, said ribs are circumferentially spaced equally from each other. In this way, the force exerted by the second turns on the piston rod is distributed substantially uniformly along the entire outer surface of the piston rod.

[0079] Preferably, the ribs have a length less than that of the piston rod.

[0080] Preferably, each rib has a thickness less than its length. The ribs are therefore thin, so they can deform when coupled by interference with the second coils of the coil spring. The second coils will also deform when coupled by interference with the ribs of the piston rod. However, this deformation does not involve the first coils either, which must in fact retain their original shape to allow the coil spring to advance correctly inside the nut.

[0081] Preferably, the device comprises an anti-rotation member disposed at a second free end of the helical spring opposite said first free end. In this way, the helical spring does not rotate on itself due to the rotation of the nut. The Applicant has in fact considered that a rotation on itself of the helical spring would make the movement of the piston uncontrollable and there could even be the risk that the helical spring rotates on itself without pushing the piston. Rather, it is necessary to provide precise control of the movement of the piston, and more particularly a precise relationship between the number of turns of the nut and the movement of the piston in order to be able to deliver the correct dose of medication.

[0082] Preferably, said anti-rotation member comprises a main body slidably associated with an interior surface of the base wall and a pin extending cantilevered from the main body and associated with the second free end of the coil spring.

[0083] Preferably, the main body has a height such that, when the second free end of the coil spring is associated with the pin, there are no parts of the coil spring which are at a height higher than that of the main body, so as to control the thickness of the device.

[0084] Preferably, the spindle has an outside diameter smaller than the inside diameter of the first turns.

[0085] Preferably, the main body comprises a recess slidably coupled to a track that is integral with the base wall of the distribution module. The coupling between the recess of the main body and the track of the distribution module allows the main body, and therefore the coil spring, to be able to slide only relative to the distribution module. The track in particular defines a path along which the main body, and therefore the coil spring, slides when the nut turns.

[0086] Preferably, the second free end of the helical spring comprises some of said first turns.

[0087] Preferably, the first turns of the coil spring have a predetermined winding pitch and the spindle comprises an external thread coupled to the first turns mentioned above and having a thread pitch equal to the winding pitch.

[0088] Preferably, the coils of the helical spring have a predetermined winding direction and the external thread of the spindle has a thread direction consistent with the winding direction.

[0089] In this description, the thread direction is consistent with the winding direction of the coils of the coil spring if rotation of the coil spring in the winding direction involves screwing the coils of the coil spring onto the spindle.

[0090] The anti-rotation mechanism described above does not require significant structural modifications to the coil spring, with a consequent reduction in the production cost and the purchase cost of the device, and does not require special machining on the coil spring, thus avoiding the risk of introducing undesirable residual stresses due to such machining into the coil spring. Brief description of the figures

[0091] Other features and advantages of the present invention will become clearer upon reading the following detailed description of preferred embodiments thereof, made with reference to the accompanying drawings and given for informational and non-limiting purposes. In these drawings:

[0092] [Fig-1] - [Fig.l] is a perspective view of a device according to the present invention;

[0093] [Fig.2] - [Fig.2] is a perspective view of a module of the device of [Fig.l]

[0094] [Fig.3] - [Fig.3] is a perspective view of another module of the device of the [Fig.l];

[0095] [Fig.4] - [Fig.4] is a top view of the module of [Fig.2] without cover;

[0096] [Fig.5] - [Fig.5] is an exploded perspective view from below the module of [Fig.2];

[0097] [Fig.6] - [Fig.6] is an enlargement of a part of [Fig.5] from a different point of view;

[0098] [Fig.7] - [Fig.7] is an enlargement of a detail of [Fig.6];

[0099] [Fig.8] - [Fig.8] is an enlargement of the part of [Fig.7] from a different point of view;

[0100] [Fig.9] - [Fig.9] is a perspective view of another part of [Fig.5] from a different point of view;

[0101] [Fig. 10] - [Fig. 10] is an enlargement of a portion of the module of [Fig.2] in an operating configuration thereof;

[0102] [Fig. 11] - [Fig. 11] is a cross-sectional view of a detail of the module of [Fig.2];

[0103] [Fig. 12] - [Fig. 12] is a perspective top view of the module of [Fig.2] without the cover and certain components;

[0104] [Fig.13] - [Fig.13] is a perspective sectional view of a portion of [Fig.12];

[0105] [Fig. 14] - [Fig. 14] an enlargement of a component shown in [Fig. 12];

[0106] [Fig. 15] - [Fig. 15] is a perspective sectional view of the part of [Fig. 13] in another operating configuration;

[0107] [Fig.16] - [Fig.16] is a side sectional view of another part of [Fig.12];

[0108] [Fig. 17] - [Fig. 17] is an enlarged perspective view of an additional part of [Fig. 12] without another component. Detailed description of the invention

[0109] In [Fig. 1], a wearable type device for subcutaneous administration of a medicament according to the present invention is indicated by the reference numeral 1.

[0110] The device 1 comprises a distribution module 2, shown in [Fig.2], and a control module 3, shown in [Fig.3].

[0111] The device 1 is obtained by mutually coupling the dispensing module 2 and the control module 3. This coupling is reversible, that is to say that the two modules 2 and 3 can be decoupled after being coupled. The control module 3 is preferably of a different color and / or material than the administration module 2, so as to help the user distinguish the two modules 2 and 3 during coupling.

[0112] One or more seals (not shown) are interposed between the distribution module 2 and the control module 3 in order to ensure the sealing of the mutual coupling.

[0113] The dispensing module 2 is preferably disposable, while the control module 3 is preferably reusable. In other words, the dispensing module 2 is configured to be applied to the patient's body only once and for a certain period of time to administer the medication, completely or in part, in one or more successive injections, even spaced apart. temporally from each other. Conversely, the control module 3 can be used several times, by coupling it from time to time to a new distribution module 2.

[0114] As shown in [Fig. 3], the control module 3 comprises a body 4 and a cover 5 associated with the body 4, preferably by ultrasonic welding. The Applicant believes that ultrasonic welding is preferable to laser welding because the latter requires the use of transparent materials, the use of which is however not preferred for the control module 3 since it can be personalized with different colors and / or finishes.

[0115] Between the body 4 and the cover 5, a housing compartment (not shown) is defined which contains a control unit (not shown) configured to control the administration of the medicament from the dispensing module 2, a motor (not shown) which rotates a magnetic drive rotor (not shown) and a power supply battery (not shown) configured to power the control unit and the motor.

[0116] The control module 3 further comprises an activation button 3a, by pressing which the patient activates the device 1.

[0117] As shown in [Fig.2], the distribution 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 body 4 of the control module 3. Preferably, the intermediate cover 15 is welded to the main body 11 by laser welding. The Applicant believes that the latter is preferable to ultrasonic welding because the assembly of the distribution module 2 is carried out with all the members described below already mounted on the main body 11 and the use of ultrasonic welding would risk accidentally activating these members during the execution of the welding.

[0118] As shown in Figures 1 and 2, the main body 11 comprises a base wall 12 configured to come into contact with the patient's body by interposition of an adhesive patch, not shown. The base wall 12 has a substantially flat outer surface defining a resting plane P on the patient's skin. The base wall 12 is made of a rigid material, preferably a plastic material.

[0119] The base wall 12 has a substantially rectangular shape, with rounded corners 12a. The base wall 12 has two long sides 12b oriented along a first direction A parallel to the plane P and two short sides 12c oriented along a second direction B parallel to the plane P and orthogonal to the first direction A (Figures 1 and 2).

[0120] A housing compartment 10 is defined between the main body 11 and the intermediate cover 15 ([Fig.4]).

[0121] The housing compartment 10 is configured to house a plurality of components, including a cartridge 20. As indicated above, the dispensing module 2 is preferably disposable and does not provide for the possibility of recharging or replacing the cartridge 20. It is therefore configured to be discarded after removal of the device 1 from the patient's body.

[0122] As shown in Figures 4 and 5, the cartridge 20 has an elongated shape and comprises a substantially cylindrical container 22, made of a plastic or glass material and containing the medicament to be administered to the patient. A pierceable septum 24 which closes the container 22 and ensures its sterility until the device 1 is used is arranged at an end portion 23 of the container 22.

[0123] The container 22 comprises a main part 22a and a neck 22b having a reduced section interposed between the main part 22a and the end part 23. The pierceable septum 24 is retained by an aluminum ferrule 23a coupled to the end part 23. A plunger 26 (shown in [Fig.4]) is disposed in a sealed manner inside the container 22 and can slide in the container 22 to administer the medicament.

[0124] As shown in Figures 4 and 5, the cartridge 20 is housed with play in a housing seat 50, also called herein an “elongated seat”, specifically provided in the housing compartment 10 and having precisely an elongated shape.

[0125] As illustrated in [Fig.5], an elongated opening 13 is formed in the base wall 12 at the elongated seat 50 to allow insertion of the cartridge 20 into the elongated seat 50 during assembly of the dispensing module 2.

[0126] The elongated opening 13 has a substantially rectangular shape and is sufficiently wide to allow the insertion of the cartridge 20 into the elongated seat 50 along an insertion direction C which is substantially orthogonal to the plane P of the base wall 12 (Figures 1 and 5), without consequently requiring rotations of the cartridge 20.

[0127] The elongated seat 50 has, in a top view thereof, a substantially rectangular shape and extends along a longitudinal direction L which is substantially parallel to the first direction A.

[0128] The elongated seat 50 is arranged near a continuous side wall 16 of the distribution module 2. Said side wall 16 defines a side wall of the elongated seat 50.

[0129] The elongated seat 50 is delimited, along the insertion direction C of the cartridge 20, by a closing door 14 described below and by a lower surface 50c (figures 6 and 7) arranged on the side opposite the elongated opening 13 relative to the cartridge 20.

[0130] The elongated seat 50 is delimited, along a direction orthogonal to the insertion direction C and to the longitudinal direction L, by the continuous side wall 16 of the distribution module 2 and, preferably, by an inner side wall 50d ([Fig.8]) arranged on the side opposite the continuous side wall 16 with respect to the cartridge 20. The purpose of the inner side wall 50d is to avoid any possible interference between the cartridge 20 and the various functional members of the device 1 which are provided in the distribution module 2. Said inner side wall 50d is therefore only a safety wall and does not define / guide the positioning of the cartridge 20 in the elongated seat 50. Multiple inner side walls, or no inner side walls, can also be envisaged.

[0131] As shown in [Fig.5], the elongated seat 50 comprises, proximate an end portion 50b thereof, a resting portion 52 configured to support the main portion 22a of the container 22 of the cartridge 20 when the cartridge 20 is inserted into the elongated seat 50. This resting portion 52 has a cradle shape.

[0132] As shown in [Fig.4], the housing compartment 10 houses a plurality of components defining a fluid path 30 configured to be traversed by the medicament during subcutaneous administration of the medicament, thereby enabling transfer of the medicament from the cartridge 20 to the patient's body.

[0133] The fluid path 30 includes a piercing needle 32 configured to pierce the pierceable septum 24, an injection needle (not shown) configured to be inserted into the patient's body, and a flexible tube 36 that fluidly connects the piercing needle 32 and the injection needle mentioned above.

[0134] In particular, 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.

[0135] The support member 42 is slidably mounted on a sliding guide 44 provided in the main body 11. The support member 42 is movable between a first operating position in which the piercing needle 32 is spaced from the pierceable septum 24 (as illustrated for example in [Fig. 4]) and the fluid path 30 is closed, and a second operating position in which the piercing needle 32 has pierced the pierceable septum 24 and extends into the interior of the container 22, thereby opening the fluid path 30.

[0136] As shown in Figures 5 to 7, 10 and 11, the housing compartment 10 further houses a plurality of components defining retaining members 54 which are configured to retain the cartridge 20 in a nominal position within the elongated seat 50 during operation of the device 1. This nominal position is that capable of allowing the piercing needle 32 to penetrate inside the container 22 of the cartridge 20 reaching the depth which is necessary to allow the medicament to exit the cartridge 20.

[0137] In particular, the retaining members 54, when they act on the cartridge 20, interact with the cartridge 20 along a retaining direction T parallel or coincident with the longitudinal direction L.

[0138] The retaining members 54 comprise a support element 56 and a pushing element 58 arranged on the side opposite the support element 56 with respect to the cartridge 20.

[0139] The support element 56 is arranged at an end portion 50a of the elongate seat 50 opposite the end portion 50b and has a longitudinal through opening 56a facing towards the elongate opening 13 and configured to allow the insertion of the cartridge 20 into the elongate seat 50 orthogonally to the plane P by a simple translational movement. The support element 56 is shaped to accommodate the clearance of the end portion 23 of the container 22, so as to compensate for the mounting tolerances of the ferrule 23a of the cartridge 20.

[0140] As shown in Figures 7 and 10, the support element 56 comprises an axial abutment surface 56c against which the end portion 23 of the cartridge 20 is configured to abut when the cartridge 20 is retained in position in the housing seat 50 by the retaining members 54. The abutment surface 56c has a substantially semi-annular shape and is arranged around a substantially semi-circular axial through-opening 56b of the support element 56 which is configured to allow the passage of the piercing needle 32 (Figures 7 and 10).

[0141] The support member 56 also includes a resting member 57 configured to support the neck 22b of the container 22 of the cartridge 20 when the cartridge 20 is inserted into the elongated seat 50.

[0142] As shown in Figures 12 to 15, the thrust element 58 is firstly arranged at the end portion 50b of the elongated seat 50 opposite the end portion 50a.

[0143] The pushing element 58 is movable towards the support element 56 to allow the device 1 to move from an initial configuration thereof to a final configuration thereof.

[0144] The thrust element 58 comprises a piston 59 comprising a rod 59a and a disc 59b extending substantially orthogonally to the rod 59a and configured to exert a thrust on the plunger 26.

[0145] A plurality of longitudinal ribs 59d are formed on an outer side surface 59c of the rod 59a of the piston 59. These ribs 59d are circumferentially spaced equally from each other. They have a length less than that of the rod 59a and a thickness less than their length.

[0146] In the initial configuration of the device 1, the support element 56 and the piston 59 do not act on the cartridge 20 along the retaining direction T. In this initial configuration, the end portion 23 of the container 22 is in a distal position relative to the abutment surface 56c, the neck 22b of the container 22 rests on the resting element 57 and the main portion 22a of the container 22 rests on the resting portion 52. The cartridge 20 is movable in the elongated seat 50 along the longitudinal direction L.

[0147] In the final configuration of the device 1, the support element 56 and the piston 59 interact with the cartridge 20 along the retaining direction T and lock it inside the elongated seat 50 in the nominal position. In this final configuration, the end portion 23 of the container 22 abuts against the abutment surface 56c ([Fig. 10]) due to the thrust exerted by the disc 59b of the piston 59 on the plunger 26 and the cartridge 20 does not rest on the rest portion 52 and on the rest element 57.

[0148] After reaching the final configuration of the device 1, the thrust of the piston 59 on the plunger 26 causes the plunger 26 to slide inside the container 22 and the medication to exit from the container 22 through the piercing needle 32.

[0149] As shown in Figures 5, 6, 9 and 11, the device 1 comprises a closing door 14 configured to close the elongated opening 13. The closing door 14 has a substantially rectangular shape and is made of a transparent plastic material.

[0150] When assembling the dispensing module 2, after the cartridge 20 has been inserted into the elongated seat 50 through the elongated opening 13, the latter is closed by welding, preferably by laser welding, the closing door 14 to the dispensing module 2, so as to prevent tampering with the medicament contained in the cartridge 20.

[0151] The closing door 14 comprises, on a substantially flat inner surface 14a thereof facing the elongated seat 50, a perimeter rib 14b projecting toward the elongated seat 50 (Figures 9 and 11) and a plurality of reinforcing ribs 14c extending from an outer side surface 14d of the perimeter rib 14b.

[0152] The perimeter rib 14b has a continuous and closed profile. It has a shape which is substantially complementary to that of the profile of the cartridge 20.

[0153] The perimeter rib 14b is positioned close to a perimeter edge 14e of the closing door 14 so as not to obstruct the view of the cartridge 20 and the passage of light through the closing door 14.

[0154] When the device 1 is in the initial configuration and in the final configuration, the perimeter rib 14b does not come into contact with the cartridge 20.

[0155] The perimeter rib 14b defines a continuous resting surface for the cartridge 20 in the event of impacts or falls of the device 1.

[0156] As shown in [Fig.2], the intermediate cover 15 of the distribution module 2 comprises an interface wall 15a arranged on the side opposite the base wall 12 with respect to the cartridge 20 and facing the control module 3 when the distribution module 2 is coupled to the control module 3.

[0157] The interface wall 15a comprises an inspection window 17 configured to allow visual inspection of the cartridge 20 when the control module 3 is decoupled from the dispensing module 2. Conversely, when the control module 3 is coupled to the dispensing module 2, the inspection window 17 is covered by the control module 3.

[0158] The inspection window 17 is substantially parallel to the base wall 12.

[0159] The cartridge 20 is interposed between the inspection window 17 and the closing door 14 of the elongated opening 13.

[0160] The interface wall 15a further comprises a circular portion 18. The circular portion 18 is configured to allow the magnetic drive rotor of the control module 3 to actuate in rotation by magnetic coupling a magnetic rotor 19 provided in the distribution module 2 at the circular portion 18 when the control module 3 is coupled to the distribution module 2.

[0161] The administration of the therapy comprises the controlled movement of the plunger 26 within the container 22 towards the pierceable septum 24 due to the thrust exerted by the piston 59 when the device 1 is in the final configuration.

[0162] The piston 59 is moved by a helical spring 55 associated with the rod 59a of the piston 59 and extending inside the housing compartment 10 along a curved path 55a ([Fig. 12]).

[0163] The helical spring 55 is coupled to an internal thread 53a of a nut 53 comprising a toothed circular external profile 53b.

[0164] The nut 53 is rotatably supported outside the elongated seat 50 proximate the end portion 50b of the elongated seat 50.

[0165] The nut 53 is rotated by a drug dispensing mechanism 90 housed in the housing compartment 10 (Figures 4, 12, 13 and 15). Rotation of the nut 53 causes translation of the helical spring 55, which pushes the piston 59, thereby moving the plunger 26 ([Fig. 15]).

[0166] The helical spring 55 comprises a plurality of first turns 55b having a predetermined winding pitch, a predetermined winding direction and a first inner diameter and, at a first free end 55c of the helical spring 55, a plurality of second turns 55d associated with the rod 59a of the piston 59 and having a winding pitch and a winding direction identical to those of the first turns 55b and an inner diameter smaller than that of the first turns 55b and greater than the outer diameter of the rod 59a of the piston 59.

[0167] The first turns 55b are rotationally coupled to the internal thread 53a of the nut 53, while the second turns 55d are coupled by interference to the ribs 59d of the rod 59a of the piston 59.

[0168] The helical spring 55 thus acts as a flexible shaft of the piston 59 and as a threaded connection, so as to achieve a screw-nut type coupling with the nut 53.

[0169] In order to prevent the helical spring 55 from rotating on itself when the nut 53 rotates, the distribution module 2 comprises, at a second free end 55e of the helical spring 55 opposite the first free end 55c, an anti-rotation member 51.

[0170] As shown in Figures 16 and 17, this anti-rotation member 51 comprises a main body 51a and a pin 51b extending cantilevered from the main body 51a substantially orthogonally to the latter.

[0171] A circumferential recess 5Id is interposed between the main body 5la and the pin 51b.

[0172] The pin 51b has an outside diameter smaller than the inside diameter of the first turns 55b and is associated with the second free end 55e of the helical spring 55.

[0173] In particular, the spindle 51b comprises an external thread 51e coupled to the first turns 55b and having a thread pitch equal to the winding pitch of the first turns 55b and a thread direction consistent with the winding direction of the helical spring 55.

[0174] The main body 5la is configured such that, when the helical spring 55 is screwed onto the pin 51b, the total height of the anti-rotation member 51 relative to the plane P is less than the maximum height of the helical spring 55 relative to the plane P.

[0175] The main body 51a includes a recess 51c slidably coupled to a track 12f which is integral with an inner surface 12e of the base wall 12 of the distribution module 2. The coil spring 55 is not shown in [Fig. 17] to highlight the sliding coupling between the recess 51c and the track 12f.

[0176] The assembly of the dispensing module 2 comprises inserting the cartridge 20 into the elongated seat 50, closing the elongated opening 13 with the closing door 14 and welding the closing door 14 to the base wall 12 of the main body 11 of the dispensing module 2.

[0177] At this stage, the pre-adjustment step is carried out on the distribution module 2 in order to bring the cartridge 20 into the nominal position and the device 1 into the final configuration.

[0178] The presetting step includes in particular: - the driving of a magnetic rotor contained in the distribution unit 2 to drive the nut 53 in rotation and therefore to move the helical spring 55 in translation in order to bring the disc 59b of the piston 59 into abutment against the plunger 26; - during the movement of the piston 59, the monitoring of the relative position of the plunger 26 and the disc 59b of the piston 59 by the optical inspection system; - the interruption of the movement of the piston 59 when the end part 23 of the container 22 comes into contact with the stop surface 56c.

[0179] During the pre-adjustment step, the cartridge 20 is thus free to move inside the elongated seat 50. The resting element 57 of the support element 56, the resting portion 52 and the perimeter rib 14b of the closing door 14 provide sufficient clearance for the cartridge 20 to stabilize during the pre-adjustment step, but at the same time they prevent the cartridge 20 from taking up inappropriate positions inside the elongated seat 50.

[0180] At the end of the pre-adjustment step, the device 1 is in the final configuration and the cartridge 20 is held in abutment against the abutment surface 56c by the axial pressure exerted by the disc 59b of the piston 59. The cartridge 20 is thus held in the nominal position by purely axial forces.

[0181] The resting element 57, the resting portion 52 and the perimeter rib 14b perform the function of safety containment structures. Therefore, under normal conditions, the cartridge 20 does not rest on such containment structures, but if, as a result of shocks, vibrations and / or falls of the device 1, the axial pressure has not been able to maintain the cartridge 20 in its nominal position, it cannot in any case move in translation until it loses its nominal position, because the play allowed by the containment structures is so limited that any misalignment of the cartridge 20 cannot significantly move the end portion 23 of the container 22 away from its correct position.

Claims

Claims

1. Device (1) for subcutaneous administration of a medicament, comprising: - a dispensing module (2) comprising a base wall (12) having a substantially flat outer surface configured to be applied to the skin of a patient; - an elongate seat (50) arranged inside the dispensing module (2) and extending along a longitudinal direction (L), the elongate seat (50) comprising at least one resting portion (52); - a cartridge (20) arranged in the elongate seat (50) and comprising a container (22) containing the medicament; - an elongate opening (13) formed on the base wall (12) at the elongate seat (50) and configured to allow insertion of the cartridge (20) into the elongate seat (50) along an insertion direction (C) orthogonal to the outer surface of the base wall (12);- retaining members (54) configured to interact with the cartridge (20) along a retaining direction (T) parallel or coincident with said longitudinal direction (L) and to lock the cartridge (20) inside the elongated seat (50) in a predetermined position; wherein the device (1) has an initial configuration in which the retaining members (54) do not act on the cartridge (20) along the retaining direction (T) and the cartridge (20) rests on said at least one resting portion (52) and is movable in the elongated seat (50) along said longitudinal direction (L), and a final configuration in which the retaining members (54) interact with the cartridge (20) along the retaining direction (T) and lock the cartridge (20) in said predetermined position.;

2. Device (1) according to claim 1, wherein, when the device (1) is in the final configuration, the cartridge (20) does not rest on said at least one resting portion (52).

3. A device (1) according to claim 1 or 2, wherein the retaining members (54) comprise a support member (56) disposed at a first end portion (50a) of the elongate seat (50) and a pushing member (58) which, when the device (1) is in the initial configuration, is arranged at a second end portion (50b) of the elongated seat (50), the pushing element (58) being movable towards the support element (56) to move the device (1) from the initial configuration to the final configuration.

4. Device (1) according to claim 3, wherein the container (22) comprises an end portion (23) proximal to the support element (56) and wherein the support element (56) comprises an abutment surface (56c) which, when the device (1) is in the initial configuration, is in a distal position relative to said end portion (23) and which, when the device (1) is in the final configuration, is in abutment against said end portion (23).

5. A device (1) according to claim 3 or 4, wherein the cartridge (20) comprises a plunger (26) sealingly disposed within the container (22) and the pushing member (58) comprises a piston (59) configured to push the plunger (26), wherein, before reaching the final configuration, pushing the piston (59) on the plunger (26) causes the cartridge (20) to move towards the support member (56) and, after reaching the final configuration, pushing the piston (59) on the plunger (26) causes the plunger (26) to slide within the container (22) and the medicament to flow from the container (22) through a piercing needle (32).

6. Device (1) according to any one of claims 3 to 5, wherein the support element (56) comprises a resting element (57) configured to support the end portion (23) of the container (22) when the device (1) is in the initial configuration.

7. Device (1) according to claim 6, wherein the container (22) comprises a main part (22a) and a neck (22b) having a reduced section, the neck (22) being interposed between the main part (22a) and the end part (23), wherein, when the device (1) is in the initial configuration, the neck (22b) rests on the resting element (57) and the main part (22a) rests on said at least one resting part (52).

8. Device (1) according to claim 7, wherein, when the device (1) is in the final configuration, the neck (22b) does not rest on the resting element (57).

9. Device (1) according to any one of the preceding claims, comprising a closing door (14) configured to close the elongated opening (13).

10. Device (1) according to claim 9, wherein the closing door (14) is transparent.

11. Device (1) according to claim 9 or 10, wherein the closing door (14) is welded to the distribution module (2).

12. Device (1) according to any one of claims 9 to 11, wherein the closing door (14) comprises, on a surface (14a) thereof facing the elongated seat (50), a perimeter rib (14b) projecting towards the elongated seat (50) and having a shape complementary to that of the profile of the cartridge (20).

13. Device (1) according to claim 12, wherein the perimeter rib (14b) does not come into contact with the cartridge (20) when the device (1) is in the initial configuration and in the final configuration.

14. Device (1) according to claim 12 or 13, wherein the closing door (14) comprises, on its surface (14a) facing the elongated seat (50), a plurality of reinforcing ribs (14c) configured to reinforce the perimeter rib (14b) and extending from an outer lateral surface (14d) of the perimeter rib (14b).

15. Device (1) according to any one of claims 9 to 14, wherein the dispensing module (2) comprises an interface wall (15a) arranged on the side opposite the base wall (12) with respect to the cartridge (20) and comprising an inspection window (17), wherein the cartridge (20) is interposed between the inspection window (17) and the closing door (14) of the elongated opening (13).

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