IT202200004182U1 - Device for the subcutaneous delivery of a medicinal product - Google Patents

Description

Device for the subcutaneous delivery of a medicinal product

DESCRIPTION

The present invention relates to a device for the subcutaneous delivery of a medicinal product.

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 concerns, more specifically, an ambulatory type device, i.e. configured to be applied to the patient's body in order to allow the subcutaneous administration of a pre-set dose of medicine.

The application of the device to the patient's body is carried out by a user, such as a doctor or nurse or the patient himself.

Examples of ambulatory type subcutaneous delivery devices are described in EP 3439715B1 and WO 2020/128821A1.

In all of the above devices, the medicine is initially contained in a cartridge housed inside the device and is transferred to the patient's body through a fluid pathway.

In this description, the term "fluid pathway" is used to indicate any element or assembly configured to be connected, at one of its first ends, to the cartridge housed within a device for the subcutaneous delivery of a medicinal product and comprising, at one of its ends opposite the aforementioned first end, a needle intended to be inserted into the patient's body, to allow the passage of the medicinal product from the cartridge to the patient's body through said needle.

Some ambulatory subcutaneous delivery devices have an inspection window to allow inspection of the medicinal product inside the cartridge before starting to administer the medicinal product. It is therefore advisable that the medicinal product be administered to the patient only after having verified, by visual inspection, that the medicinal product is unchanged.

Examples of ambulatory type subcutaneous delivery devices equipped with an inspection window are described in WO 2006/024650A2, WO 2003/099358A2, WO 2006/077262A1.

The Applicant noted that in all the above examples the inspection window is positioned on an external surface of the delivery device. In particular, in the devices described in WO 2006/024650A2 and WO 2003/099358A2 the inspection window is positioned on the external surface facing away from the patient's body after the delivery device has been applied to the patient's body, while in WO 2006/077262A1 the inspection window is positioned on the external surface facing away from the patient's body after the delivery device has been applied to the patient's body.

The Applicant has found that in devices in which the inspection window is located on the external surface intended to face away from the patient's body, such as in the devices described in WO 2006/024650A2 and WO 2003/099358A2, the inspection window is always accessible to the user's view (hereinafter this condition will also be briefly referred to with the expression "visible").

According to the Applicant, this entails a number of drawbacks, some of which are discussed below.

A first drawback is related to the fact that, typically, on the aforementioned external surface there is also a control interface for the delivery device, such as one or more buttons or one or more LEDs. In this case, during the application of the delivery device on the patient's body, the user (especially an inexperienced user) may not immediately identify the correct orientation to give to the delivery device in order to position it correctly on the patient's body. The user may in fact ask himself, for example, whether to orient the delivery device in such a way as to facilitate visual access to the inspection window or to the control interface, risking opting for a positioning other than the correct one. In this case the user may not be able to see any error messages communicated via the control interface.

Another drawback is related to the fact that, since the inspection window is visible, the patient would be able to inspect the medicine in the cartridge even at the end of the administration cycle. Consequently, if for example the administration therapy did not involve the administration of the entire dose of medicine in the cartridge, the patient, seeing that not all the medicine in the cartridge has been administered, could worry, without there actually being anything abnormal.

The Applicant has also found that in those devices in which the inspection window is located on the external surface intended to face the patient's body, such as the device described in WO 2006/077262A1, during administration of the medicinal product the patient may decide to move the delivery device to have visual access to the inspection window and check, perhaps just out of curiosity, the quantity of medicinal product administered and/or the quantity still present in the cartridge. It goes without saying that it would be appropriate to avoid any movement of the delivery device once it has been applied to the patient's body, so as not to risk incurring various problems, such as, for example, accidental detachment of the device from the patient's body or breakage of the needle inserted into the patient's body.

The Applicant therefore perceived the need to provide a subcutaneous delivery device in which the inspection window is positioned in such a way that it is visible only before the start of the administration therapy and not also during administration or at the end of administration, when the device is still applied to the patient's body.

The Applicant has understood that to satisfy this need it is appropriate for the dispensing device to be made in two distinct modules, one configured to house the cartridge and the other configured to house the device's control components, in particular a control unit and the power battery for the control unit, these modules also being configured to be coupled to each other in correspondence with respective interface surfaces which, after having coupled the two modules, have respective portions of surfaces that are not visible. The Applicant has therefore thought of arranging the inspection window on the interface surface of the module in which the cartridge is housed in correspondence with a portion of the surface that is covered by the other interface surface when the two modules are coupled to each other. In this way the inspection window is visible only before coupling the two modules together, while it is not accessible, not even visually, during the administration of the medicinal product and at the end of the administration when the two modules are still coupled to each other.

The present invention therefore concerns a device for the subcutaneous delivery of a medicinal product, comprising:

- a delivery module configured to house a cartridge containing a medicinal product to be delivered to a patient via a needle; - a control module reversibly coupled to the delivery module and configured to house at least one control unit and a battery to power said control unit;

wherein said dispensing module comprises a first interface surface facing the control module and said control module comprises a second interface surface facing the first interface surface;

wherein said first interface surface includes an inspection window covered by the second interface surface and configured to permit visual inspection of the cartridge when said control module is decoupled from the dispensing module.

Such a device prevents the user from having any access to the inspection window after the delivery device is coupled to the patient's body. In fact, the inspection window is accessible only before the delivery module and the control module are coupled together. To gain access to the inspection window after the two modules have been coupled, they must be uncoupled, an operation that is obviously done only at the end of the therapy administration.

The above device may include one or more of the following features, taken individually or possibly combined with each other.

Preferably, the dispensing module is disposable.

Preferably, the control module is reusable.

Preferably, the delivery module comprises an application surface configured to contact the patient's body. The delivery module then comprises two opposing external surfaces: one of such external surfaces defines the interface surface of the delivery module and is intended to face away from the portion of the patient's body to which the delivery device is to be applied and to be covered by the interface surface of the control module when the latter is coupled to the delivery module, while the other of the aforementioned external surfaces defines the application surface of the delivery module and is intended to face the portion of the patient's body to which the delivery device is to be applied.

Preferably, the dispensing module is configured to accommodate said cartridge between the application surface and the inspection window and, hence, between the application surface and the interface surface of the dispensing module.

Preferably, the inspection window is parallel to the application surface. This arrangement allows for easy inspection of the medicinal product contained in the cartridge when the two modules are decoupled.

In a preferred embodiment of the device of the present invention, the application surface comprises a light-permeable portion configured to allow external light to reach the cartridge when the application surface is not in contact with the patient's body.

Preferably, the light-permeable portion and the inspection window are mutually overlapping. In this way, light entering the dispensing module through the light-permeable portion of the application surface can reach the inspection window. The presence of the cartridge between the application surface and the inspection window does not hinder the reaching of said light to the inspection window since cartridges are typically made of transparent material (and therefore permeable to light) to allow the medicinal product contained therein to be seen.

Preferably, the portion permeable to light is larger than the inspection window. This arrangement allows a relatively large amount of light to reach the inspection window.

Preferably, the application surface includes an opening configured to permit insertion of the cartridge into the dispensing module during assembly of the dispensing module.

Preferably, the light-permeable portion comprises a transparent element fixed at said opening to occlude said opening. Said transparent element then acts as a closing door for the cartridge housing seat. Such door, being transparent, allows light to enter the dispensing module to reach the cartridge and the inspection window.

Preferably, said transparent element is fixed in correspondence with said opening by laser welding. This type of fixing is possible precisely because the closing door of the cartridge housing is transparent.

Preferably, the application surface includes an adhesive layer configured to attach the delivery module to the patient's skin.

Preferably, a portion of said adhesive layer is placed on said transparent element.

Preferably, said adhesive layer is configured to allow external light to reach the cartridge when the application surface is not in contact with the patient's body. Therefore, said adhesive layer does not impede the entry of light into the delivery module through the light-permeable portion of the application surface.

Preferably, this adhesive layer is not transparent, so as to prevent the user from being able to see the cartridge through the transparent element.

The characteristics of the present invention will be apparent from the detailed description that follows of some examples of its embodiment, provided purely by way of example and not of limitation, a description that will be conducted with reference to the attached drawings, in which:

- figure 1 shows a perspective view of a device for the subcutaneous delivery of a medicinal product according to the present invention; - figure 2 shows a perspective view of a part of the device of figure 1;

- figure 3 shows a bottom view of the part of figure 2;

- figure 4 shows a sectional view of the part of figure 2; - figure 5 shows a perspective view of another part of the device of figure 1;

- figure 6 shows a bottom view of the part of figure 5;

- Figure 7 shows a side view of the part of Figure 5;

- figure 8 shows an enlargement of some components of the device in figure 1 in a first operational configuration, with some parts hidden to highlight others;

- figure 9 shows an enlargement of some components of the device of figure 1 in a second operating configuration, with some parts hidden to highlight others;

- Figure 10 shows an enlargement of some components of the device in Figure 1 in a third operating configuration, with some parts hidden to highlight others.

A device for the subcutaneous delivery of a medicinal product, which is the subject of the present invention, is illustrated schematically in figure 1 and is indicated by the numerical reference 1.

Device 1 comprises a dispensing module 10, shown in Figures 2 through 4, and a control module 20, shown in Figures 5 through 7.

The device 1 is obtained by mutually coupling the dispensing module 10 and the control module 20. As will become clear later in this description, this coupling is reversible, i.e. the two modules 10 and 20 can be uncoupled after being coupled.

The delivery module 10 includes an internal housing compartment 101 (illustrated in figure 4) configured to house a cartridge (not illustrated). The cartridge includes a cylindrical container made of plastic or glass containing a medicinal product to be delivered to a patient and a pierceable septum that closes the container and ensures its sterility until the device 1 is used.

Prior to use of the device 1, the delivery module 10 is associated with a fluid path (not shown) configured to allow the passage of the medication from the cartridge to the patient's body. This fluid path includes a needle configured to pierce the septum (hereinafter referred to as the "septum needle"), a skin needle configured to be inserted into the patient's body, and a flexible tube that connects the aforementioned needles with fluid.

The delivery module 10 also includes a fluid path opening system (not shown) configured to move the septum needle and/or the cartridge such that the septum needle pierces the septum and enters into fluid communication with the inside of the cartridge so that the medication can be withdrawn from it.

The delivery module 10 also includes a skin needle insertion and retraction mechanism (not illustrated). This mechanism is configured to move the skin needle by inserting it into the patient's body at the start of therapy and by retracting it from the patient's body at the end of therapy.

The delivery module 10 further includes a drive chain (not shown) configured to perform drug delivery following opening of the fluid pathway and insertion of the skin needle into the patient's body.

The delivery module 10 is preferably disposable. In other words, the delivery module 10 is configured to be applied to the patient's body only once and for a certain period of time and to deliver, completely or partially, the contents of the cartridge in one or more subsequent injections, even spaced apart in time. The delivery module 10 does not provide for the possibility of refilling or replacing the cartridge and is configured to be disposed of after removal from the patient's body.

The delivery module 10 includes an application surface 102 configured to contact the patient's body. The application surface 102 is substantially flat.

The application surface 102 defines a reference plane. With respect to the application surface 102, a first direction D1 (figure 3) is defined, parallel to the application surface 102 and to a coupling direction A1 of the two modules 10 and 20, a second direction D2 (figure 4) perpendicular to the application surface 102 and a third direction D3 (figure 3) parallel to the application surface 102 and perpendicular to the first direction D1 and to the second direction D2. When used in reference to the control module 20 or parts thereof, the first direction D1 (figures 6, 8-10), the second direction D2 (figure 7) and the third direction D3 (figures 6, 8-10) are to be understood as referring to a configuration of the control module 20 in which the control module 20 is coupled to the dispensing module 10.

The application surface 102 comprises a base wall 103 having a substantially rectangular shape, with rounded corners. The base wall 103 has two short sides oriented in the first direction D1 and two long sides oriented in the third direction D3.

The base wall 103 is made of a rigid material, preferably a plastic material. The base wall 103 partially delimits the housing compartment 101 of the dispensing module 10.

As illustrated in Figure 4, the base wall 103 includes an opening 104 configured to allow the cartridge to be positioned in the housing compartment 101 during assembly of the dispensing module 10.

The base wall 103 also comprises a transparent element 105, made for example of transparent plastic material, fixed in correspondence with the opening 104 to occlude it. The transparent element 105 is applied during assembly after having introduced the cartridge into the housing compartment 101 through the opening 104 and is fixed in correspondence with the opening 104 by laser welding.

The application surface 102 further includes an adhesive layer 106 configured to attach the delivery module 10 to the patient's body. The adhesive layer 106 has an adhesive face attached to the base wall 103 and an opposing adhesive face configured to attach to the patient's skin.

The adhesive layer 106 is configured to be permeable to light. The adhesive layer 106 covers the transparent element 105 and together forms a light-permeable portion 107 in the application surface 102. The light-permeable portion 107 is configured to allow external light to reach the cartridge in the housing compartment 101 when the application surface is not in contact with the patient's body.

The adhesive layer 106 is not transparent and is configured to prevent the cartridge from being seen in the housing compartment 101 through the light-permeable portion 107.

With reference to Figures 1 and 2, the dispensing module 10 comprises two opposing first peripheral gripping surfaces 110. The first peripheral gripping surfaces 110 extend along the first direction D1 and along the second direction D2.

The first peripheral gripping surfaces 110 are adjacent to the application surface 102 and partially delimit the housing compartment 101 on opposite sides.

The first perimeter gripping surfaces 110 are positioned at opposite short sides of the base wall 103 and form an angle substantially equal to 90° with the base wall 103.

The first perimeter gripping surfaces 110 extend along the first direction D1 from the same long side of the base wall 103 towards the opposite long side following the respective short side.

The first perimeter gripping surfaces 110 extend in the first direction D1 for approximately half the extent of the short sides of the base wall 103.

The first perimeter gripping surfaces 110 extend from the base wall 103 along the second direction D2 away from the base wall 103.

The first peripheral grip surfaces 110 have substantially equal dimensions to each other along the first direction D1 and the second direction D2. In particular, the two first peripheral grip surfaces 110 are specular with respect to a first central plane of the dispensing module 10 extended along the first direction D1 and the second direction D2.

Still referring to figures 1 and 2, the dispensing module 10 comprises a third perimeter surface 111 which extends along the second direction D2 and the third direction D3.

The third perimeter surface 111 is adjacent to the application surface 102 and partially delimits the housing compartment 101.

The third perimeter surface 111 is positioned in correspondence with one of the long sides of the base wall 103 and forms an angle with the base wall 103 that is substantially equal to 90°.

The third perimeter surface 111 extends from the base wall 103 along the second direction D2 away from the base wall 103.

The third perimeter surface 111 extends along the third direction D3 from a first perimeter gripping surface 110 to the other first perimeter gripping surface 110 following the respective long side of the base wall 103.

The third perimeter surface 111 has a size substantially equal to the size of the first perimeter gripping surfaces 110 in the second direction D2.

Each first perimeter gripping surface 110 is connected to the third perimeter surface 111 by a rounded connection.

As illustrated in Figures 2 and 4, the dispensing module 10 includes a first interface surface 115 configured to face the control module 20 when the dispensing module 10 is coupled to the control module 20. The first interface surface 115 faces away from the application surface 102.

The first interface surface 115 includes a first interface portion 116. The first interface portion 116 is defined at the portion of the dispensing module 10 most distal from the application surface 102 along the second direction D2.

The first interface portion 116 extends from one of the first perimeter gripping surfaces 110 to the other first perimeter gripping surface 110. The first interface portion 116 extends from the third perimeter surface 111 along the first direction D1. The first interface portion 116 partially delimits the housing compartment 101 on the opposite side to the base wall 102.

The first interface portion 116 has a concave profile defined by two opposite surfaces 117 parallel to the two first perimeter gripping surfaces 110 and a connecting surface 118 parallel to the third perimeter surface 111.

Each of the two opposite surfaces 117 of the concave profile of the first interface portion 116 is closer to the respective first perimeter gripping surface 110 than the first central plane of the dispensing module 10.

The connecting surface 118 of the concave profile of the first interface portion 116 is closer to the third perimeter surface 111 than to a center plane of the dispensing module 10 extending along the second direction D2 and the third direction D3.

As illustrated in Figure 2, the first interface surface 115 further comprises a second interface portion 120 substantially parallel to the application surface 102. The second interface portion 120 is positioned at a lesser distance from the application surface 102 than the first interface portion 116.

The second interface portion 120 extends along the third direction D3 from one of the short sides to the opposite short side of the rectangular profile of the base wall 103 and, along the first direction D1, from the long side opposite the third perimeter wall 111 towards the third perimeter wall 111.

The second interface portion 120 does not extend between the first perimeter gripping surfaces 110.

Still referring to Figure 2, the first interface surface 115 also comprises a third interface portion 121 extending from the second interface portion 120 to the first interface portion 116 and from one of the first perimeter grip surfaces 110 to the other of the first perimeter grip surfaces 110. The third interface portion 121 delimits the housing compartment 101 on the opposite side to the third perimeter portion 111.

The third interface portion 121 comprises respective ends 122 positioned in correspondence with the first peripheral gripping surfaces 110 and a protruding portion 123 positioned between the ends 122 and which protrudes on the opposite side with respect to the third peripheral surface 111.

The first interface surface 115 further comprises a first circular portion 124. The first circular portion 124 is configured to allow a driving rotor (not shown) provided in the control module 10 to magnetically rotate a magnetic rotor (not shown) provided in the dispensing module 10 at the first circular portion 124 when the control module 20 is coupled to the dispensing module 10.

The first circular portion 124 is located between the first interface portion 116 and the third interface portion 121. The first circular portion 124 partially delimits the housing compartment 101 on the opposite side to the application surface 102 and defines a recess with respect to the first interface portion 116.

The first interface surface 115 further includes an inspection window 125 (Figures 2 and 4) configured to permit visual inspection of the cartridge when the control module 20 is decoupled from the dispensing module 10.

The inspection window 125 is positioned in correspondence with the first portion of interface 116, overlapping the housing compartment 101. The inspection window 125 is parallel to the application surface 102.

The inspection window 125 is located on the opposite side of the housing compartment 101 with respect to the light-permeable portion 107. In particular, the inspection window 125 and the light-permeable portion 107 are mutually overlapping. More specifically, the inspection window 125 and the light-permeable portion 107 are arranged in such a way that the cartridge is positioned between them.

The light-permeable portion 107 is larger than the inspection window 125.

Inspection window 125 is configured to be covered by control module 20, when control module 20 is coupled to dispensing module 10, thereby preventing visual inspection of the cartridge.

The control module 20 is preferably in a different color and/or material than the dispensing module 10, in order to help the user distinguish the two modules during pairing.

The control module 20 in turn comprises a housing (not shown) within which are housed a control unit, usually made on a printed circuit board and configured to control the delivery of the drug from the delivery module 10, and a power battery configured to power the control unit.

As illustrated in Figures 1 and 5, the control module 20 includes a top surface 202 extending substantially parallel to the application surface 102 when the control module 20 is coupled to the dispensing module 10.

The top surface 202 has a substantially rectangular shape, with rounded corners, mirroring the shape of the base wall 103. Similarly to the latter, the top surface 202 has two short sides oriented in the first direction D1 and two long sides oriented in the third direction D3.

The control module 20 includes two opposing second perimeter gripping surfaces 210. The opposing second perimeter gripping surfaces 210 extend along the first direction D1 and along the second direction D2.

The second perimeter gripping surfaces 210 are adjacent to the top surface 202 and partially delimit the aforementioned housing on opposite sides.

The second perimeter gripping surfaces 210 are positioned at opposite short sides of the top surface 202 and form an angle of substantially 90° with the top surface 202.

The second perimeter gripping surfaces 210 extend along the first direction D1 from the same long side of the top surface 202 towards the opposite long side following the respective short side.

The second perimeter gripping surfaces 210 extend along the first direction D1 for approximately half the extent of the short sides of the top surface 202.

The second perimeter gripping surfaces 210 extend from the top surface 202 along the second direction D2 away from the top surface 202, i.e., toward the application surface 102 when the control module 20 is coupled to the dispensing module 10.

The second perimeter gripping surfaces 210 have substantially equal dimensions to each other along the first direction D1 and the second direction D2. In particular, the two second perimeter gripping surfaces 210 are specular with respect to a second central plane of the control module 20 extending along the first direction D1 and the second direction D2 and coinciding with the first central plane of the dispensing module 10 when the control module 20 is coupled to the dispensing module 10.

Furthermore, the two first perimeter gripping surfaces 110 and the two second perimeter gripping surfaces 210 have substantially equal dimensions along the first direction D1.

When control module 20 is coupled to dispensing module 10, each first peripheral gripping surface 110 is adjacent to and aligned with, or flush with, a respective second peripheral gripping surface 210 to define a substantially continuous lateral surface of device 1.

As illustrated in Figures 1, 5-7, the control module 20 includes a fourth perimeter surface 211 that extends along the second direction D2 and the third direction D3.

The fourth perimeter surface 211 is adjacent to the top surface 202 and partially delimits the aforementioned housing.

The fourth perimeter surface 211 is positioned in correspondence with one of the long sides of the top surface 202 and forms an angle with the top surface 202 that is substantially equal to 90°.

The fourth perimeter surface 211 extends from the top surface 202 along the second direction D2 away from the top surface 202, i.e., toward the application surface 102 when the control module 20 is coupled to the dispensing module 10.

The fourth perimeter surface 211 extends along the third direction D3 from a second perimeter gripping surface 210 to the other second perimeter gripping surface 210 following the respective long side of the top surface 202.

The fourth perimeter surface 211 has a size substantially equal to the size of the second perimeter gripping surfaces 210 in the second direction D2.

Each second perimeter gripping surface 210 is connected to the fourth perimeter surface 211 by a rounded connection 212.

When the control module 20 is coupled to the dispensing module 10, the fourth perimeter surface 211 is positioned substantially parallel to the third perimeter surface 111, on the opposite side to the latter.

The sum of the dimensions of any one of the first perimeter gripping surfaces 110 and any one of the second perimeter gripping surfaces 210 along the first direction D1 is less than the dimension of the third perimeter surface 111 and that of the fourth perimeter surface 211 along the third direction D3.

As illustrated in Figures 6 and 7, the control module 20 includes a second interface surface 215 configured to face the first interface surface 115 of the dispensing module 10 when the dispensing module 10 is coupled to the control module 20.

The second interface surface 215 is substantially counter-shaped to the first interface surface 115 and faces away from the top surface 202.

The second interface surface 215 comprises a first interface portion 216 substantially parallel to the top surface 202. The first interface portion 216 of the control module 20 is substantially counter-shaped to the second interface portion 120 of the dispensing module 10 and is configured to face it.

The first portion of interface 216 is defined at the portion of control module 20 most distal from top surface 202 along the second direction D2.

The first interface portion 216 extends from one of the second perimeter gripping surfaces 210 to the other second perimeter gripping surface 210. The first interface portion 216 is adjacent to the fourth perimeter surface 211 and extends from the fourth perimeter surface 211 along the first direction D1. The first interface portion 216 partially delimits the aforementioned housing on the opposite side with respect to the top surface 202.

The second interface surface 215 further comprises a second interface portion 220 positioned at a shorter distance from the top surface 202 than the first interface portion 216. The second interface portion 220 is substantially counter-shaped to the first interface portion 116 of the dispensing module 10 and is configured to face it.

The second interface portion 220 extends along the third direction D3 from one of the short sides to the opposite short side of the rectangular profile of the top surface 202 and, along the first direction D1, from the long side opposite the fourth perimeter wall 211 towards the fourth perimeter wall 211.

The second portion of interface 220 has a convex profile, substantially mirroring the concave profile of the first portion of interface 116.

The convex profile of the second interface portion 220 is defined by two opposite surfaces 217 parallel to the two first perimeter gripping surfaces 110 and a connecting surface 218 parallel to the fourth perimeter surface 211.

Each of the two opposite surfaces 217 of the convex profile of the second interface portion 220 is closer to the respective second perimeter gripping surface 210 than the second central plane of the control module 20.

The connecting surface 118 of the concave profile of the first interface portion 116 and the connecting surface 218 of the convex profile of the second interface portion 220 are closer to the third perimeter surface 211 than to a center plane of the device 1 extending along the second direction D2 and the third direction D3 when the control module 20 is coupled to the dispensing module 10.

The second interface surface 215 further comprises a third interface portion 221 extending from the second interface portion 220 to the first interface portion 216 and from one of the second perimeter gripping surfaces 210 to the other of the second perimeter gripping surfaces 210. The third interface portion 221 delimits the aforementioned housing on the opposite side to the fourth perimeter portion 211.

The third interface portion 221 of the control module 20 is substantially counter-shaped to the third interface portion 121 of the dispensing module 10 and is configured to face it.

The third interface portion 221 comprises respective ends 222 positioned in correspondence with the second perimeter gripping surfaces 210 and a recessed portion 223 positioned between the ends 222 and which retracts towards the fourth perimeter surface 211.

The second interface surface 215 further comprises a second circular portion 224. The second circular portion 224 of the control module 20 is substantially counter-shaped to the first circular portion 124 of the dispensing module 10 and is configured to face it.

The first circular portion 124 and the second circular portion 224 are configured to allow for precise alignment between the driving rotor provided in the control module 100 at the second circular portion 224 and the magnetic rotor provided in the dispensing module 10 at the first circular portion 224 when the control module 20 is coupled to the dispensing module 10.

The second circular portion 224 is placed between the second interface portion 220 and the third interface portion 221 and defines a protrusion with respect to the second interface portion 220.

The second interface surface 215, specifically the first interface portion 220 of the second interface surface 215, is configured to cover the inspection window 125 when the control module 20 is coupled to the dispensing module 10 so as to prevent a visual inspection of the cartridge.

One or more gaskets (not shown) are placed between at least part of the first interface surface 115 and at least part of the second interface surface 215 in order to ensure the tightness of the coupling between the dispensing module 10 and the control module 20.

As illustrated in Figure 2, the dispensing module 10 comprises opposing mating recesses 130 extending along the first direction D1. The mating recesses 130 are positioned in proximity to the first peripheral gripping surfaces 110. In particular, the mating recesses 130 are positioned in correspondence with the first interface portion 116. The mating recesses 130 extend from the opposing surfaces 117 of the concave profile of the first interface portion 116 towards the first peripheral gripping surfaces 110.

As illustrated in FIG. 5, the control module 20 includes opposing mating projections 230 extending along the first direction D1. The mating projections 230 are configured to slide in the mating recesses 130 during mating of the control module 20 to the dispensing module 10 so as to guide its sliding along the mating direction A1. The mating projections 230 are positioned in proximity to the second peripheral gripping surfaces 210.

As illustrated in Figures 6 and 7, the control module 20 includes a locking protrusion 300.

The blocking projection 300 extends from the second interface surface 215 of the control module 20 along a development direction perpendicular to the mating direction A1 and parallel to the second direction D2. More specifically, the blocking projection 300 extends from the first interface portion 216 of the second interface surface 215 along the aforementioned development direction. When the control module 20 is mated to the dispensing module 10, the blocking projection 300 protrudes toward the application surface 102.

The locking projection 300 comprises a stem 301 extending along the aforementioned development direction from the second interface surface 215 and having an end 302, and a tooth 303 extending from the end 302 parallel to the mating direction A1.

The locking projection 300 comprises a push portion 304 extending along the aforementioned development direction and a hook portion 305 extending from the push portion 304 along a direction parallel to the coupling direction A1, i.e. parallel to the first direction D1. The hook portion 302 comprises a surface located on the tooth 303, substantially parallel to the application surface 102, and facing the second interface surface 215.

The blocking protrusion 300 is located at the second central plane of the control module 20.

The control module 20 further comprises a closing projection 310, extending along a development direction parallel to the development direction of the blocking projection 300. In particular, the closing projection 310 extends along the second direction from the second interface surface 215. More specifically, the closing projection 310 extends from a mutually connecting edge of the second interface surface 215 and the fourth perimeter surface 211, flush with the fourth perimeter surface 211.

The locking protrusion 310 is located at the second central plane of the control module 20 and is spaced from the locking protrusion 300 along the mating direction A1.

As illustrated in Figures 2, 8-10, the dispensing module 10 includes a seat 400 configured to cooperate with the locking protrusion 300 during mating between the dispensing module 10 and the control module 20.

The seat 400 includes an inlet 401 configured to receive the locking protrusion 300. The inlet 401 is located on the first interface surface 115, in particular on the second interface portion 120 of the first interface surface 115, at one of the long sides of the base wall 103.

The seat 400 further includes an internal volume 402 configured to accommodate the locking protrusion 300 at the end of the coupling between the dispensing module 10 and the control module 20. The internal volume 402 is contiguous to the inlet 401, along the coupling direction A1.

The seat 400 also includes a mating portion 403 overlapping the inlet 401 and the internal volume 402 (Figure 2).

The coupling portion 403 is defined between two opposing guide surfaces 404 extending from the inlet 401 to the internal volume 402 along the coupling direction A1. In particular, the guide surfaces 404 extend along the first direction D1 and the second direction D2 and are parallel to each other. The guide surfaces 404 are adjacent to the second interface portion 121 of the first interface surface 115.

The guide surfaces 404 are configured to guide the locking protrusion 300 between the inlet 401 and the internal volume 402 during the coupling of the control module 20 with the dispensing module 10.

The mating portion 403 further comprises a stop surface 405 extending perpendicular to the mating direction A1 and facing the internal volume 402. The stop surface 405 extends between the two guide surfaces 404 along the third direction D3 and the second direction D2. The stop surface 405 is adjacent to the second interface portion 121 of the first interface surface 115 and defines a stop for the locking protrusion 300 along the mating direction A1.

The seat 400 also includes a coupling surface, not shown in the attached figures, configured to abut against the coupling portion 305 of the locking protrusion 300 when the locking protrusion 300 is housed in the internal volume 402, as in the configuration of figure 10. The coupling surface is substantially parallel to the application surface 102 and faces the application surface 102.

As illustrated in Figures 8-10, the dispensing module 10 further comprises a cursor 410 associated with the seat 400 and slidably movable between a first position and a second position along a maneuver direction M1 perpendicular to the coupling direction A1 and parallel to the application surface 102. In particular, the maneuver direction M1 is parallel to the third direction D3.

The slider 410 comprises a main body 411 slidably mounted in the seat 400.

The main body 411 includes a service portion 412 shaped to obstruct the inlet 401 when the slider 410 is in the first position and to not obstruct the inlet 401 when the slider 410 is in the second position. When the slider 410 is in the first position the service portion 412 is disposed in correspondence with the mating portion 403. When the slider 410 is in the second position the service portion 412 is disposed in a position adjacent to the mating portion 403.

The service portion 412 comprises a thrust surface 413 facing the inlet 401 when the slider 410 is in the first position. The thrust surface 413 is oriented obliquely with respect to the coupling direction A1. In particular, the thrust surface 413 is oriented according to a plane perpendicular to the application surface 102 and oriented obliquely according to an angle with respect to the third direction D3 which is preferably between 30? and 60?, even more preferably between 40? and 50?, for example equal to approximately 45?.

The service portion 412 further comprises a blocking surface 414 facing the internal volume 402 when the slider 410 is in the first position. The blocking surface 414 is oriented perpendicular to the coupling direction A1. The blocking surface 414 is parallel to the stop surface 405. In particular, the blocking surface 414 extends along the second direction D2 and the third direction D3.

The cursor 410 also comprises a control portion 416, illustrated in figure 3, which can be operated manually along the control direction M1 to move the cursor 410 from the first position to the second position. The control portion 416 protrudes from the main body 411 in the second direction D2 towards the application surface 102 until it is positioned outside the seat 400 through an opening 417 formed in the application surface 102.

The operating portion 416 is positioned substantially flush with the application surface 102 and comprises a friction surface 418 parallel to the application surface 102 and configured to allow a user to operate the slider 410 from the first position to the second position parallel to the friction surface 418 using his finger. Preferably, the friction surface 418 has a pronounced roughness or surface asperities designed to increase friction with the user's finger.

The maneuver portion 416 is positioned at the application surface 102 so that, when the device 1 is applied to the patient's body by means of the application surface 102, the maneuver portion 416 is unreachable and cannot be reached.

An elastic element 419 is interposed between a first shoulder 420 formed in the seat 400 and a second shoulder 421 formed in the slider 410 so as to exert an elastic force against the slider 410. Preferably, the elastic element 419 is a spring.

When the cursor 410 is in the first position, the spring force of the elastic element 419 holds it in the first position, both before the coupling between the dispensing module 10 and the control module 20, and at the end of the coupling between the dispensing module 10 and the control module 20. To move the cursor from the first position to the second position, the user must exert a force on the operating portion 416 along the operating direction M1 such as to overcome the spring force of the elastic element 419. When the cursor is in the second position, the elastic element 419 pushes it towards the first position.

To couple the control module 20 to the dispensing module 10, the two modules are brought together until the coupling protrusions 230 are inserted into the coupling recesses 130 and the locking protrusion 300 into the seat 400 through the inlet 401. At this point, the control module 20 is slid towards the dispensing module 10 along the coupling direction A1.

As illustrated in figures 8-10, the thrust portion 304 of the locking protrusion 300 engages the thrust surface 413 of the slider 410, which is in the first position. Thanks to the oblique orientation of the thrust surface 413, the thrust portion 304, moving along the coupling direction A1, moves the slider 410 from the first position to the second position and slides on the thrust surface 413, overcoming the spring thrust exerted on the slider 410 by the elastic element 419. In this way, the entrance 401 is freed and the locking protrusion 300 can access the internal volume 402. Alternatively, the slider 410 can be moved from the first position to the second position by manually operating the operating portion 416.

Continuing to move along the coupling direction A1, the push portion 304 disengages the push surface 413 and the blocking protrusion 300 reaches the internal volume 402. The slider 400 is thus free to return to the first position due to the restoring action exerted by the elastic element 419, so that the service portion 412 of the slider 410 obstructs the entrance 401.

The locking protrusion 300, when housed in the internal volume 402, is surrounded by: the stop surface 405, the guide surfaces 404 and the locking surface 414 and can no longer move in the mating direction A1 in either direction. Furthermore, when the locking protrusion 300 is housed in the internal volume 402 the latching portion 305 overlaps the latching surface and prevents relative movements of the dispensing module 10 and the control module 20 perpendicular to the application surface 102.

The control module 20 is thus stably coupled to the dispensing module 10.

In this configuration, the closing projection 310 is positioned so as to close the inlet 401, as illustrated in Figure 10.

Claims (9)

1. Device (1) for the subcutaneous delivery of a medicinal product, comprising: - a delivery module (10) configured to house a cartridge containing a medicinal product to be delivered to a patient via a needle; - a control module (20) reversibly coupled to the dispensing module (10) and configured to house at least one control unit and a battery to power said control unit; wherein said dispensing module (10) comprises a first interface surface (115) facing the control module (20) and said control module (20) comprises a second interface surface (215) facing the first interface surface (115); wherein said first interface surface (115) comprises an inspection window (125) covered by the second interface surface (215) and configured to allow a visual inspection of the cartridge when said control module (20) is decoupled from the dispensing module (10). 2. Device (1) according to claim 1 wherein said delivery module (10) comprises an application surface (102) configured to contact the patient's body and wherein said delivery module (10) is configured to house said cartridge between said application surface (102) and said inspection window (125). 3. Device (1) according to claim 1 or 2 wherein said inspection window (125) is parallel to said application surface (102). 4. Device (1) according to claim 2 or 3, wherein said application surface (102) comprises a light-permeable portion (107) configured to allow external light to reach said cartridge when said application surface (102) is not in contact with the patient's body. 5. Device (1) according to claim 4, wherein said light-permeable portion (107) and said inspection window (125) are mutually superimposed. 6. Device (1) according to claim 4 or 5, wherein said light-permeable portion (107) is larger than said inspection window (125). 7. Device (1) according to any of the preceding claims 4 to 6, wherein said application surface (102) comprises an opening (104) configured to allow insertion of the cartridge into the dispensing module (10) during assembly of the dispensing module (10), and wherein said light-permeable portion (107) comprises a transparent element (105) fixed at said opening (104) to occlude said opening (104). 8. Device (1) according to claim 7, wherein said application surface (102) comprises an adhesive layer (106) configured to attach said delivery module (10) to the patient's skin, a portion of said adhesive layer (106) being placed on said transparent member (105), said adhesive layer (106) being configured to allow external light to reach said cartridge when said application surface (102) is not in contact with the patient's body. 9 Device (1) according to claim 8, wherein said adhesive layer (106) is not transparent.