DE202023105887U1 - Device for subcutaneous administration of a medicament - Google Patents

Abstract

Device (1) for subcutaneous administration of a medication, comprising: - an administration module (10) configured to receive a cartridge containing a medication to be administered to a patient via a needle; - a control module (20) reversibly coupled to the delivery module (10) and configured to receive at least one control unit and a battery for powering the control unit; wherein the delivery module (10) comprises: - an application surface (102) configured to come into contact with the patient's body; - two opposing first gripping peripheral surfaces (110) which are parallel along a first direction (D1). to the application surface (102) and along a second direction (102) perpendicular to the application surface (102), the two first gripping peripheral surfaces (110) having substantially the same dimensions in the second direction (D2); wherein the control module (20) comprises: - two opposing second gripping peripheral surfaces (210) extending along the first direction (D1) and along the second direction (D2), wherein the two second gripping peripheral surfaces (210) in the second direction ( D2) have essentially the same dimensions; wherein the two first gripping peripheral surfaces (110) and the two second gripping peripheral surfaces (210) have substantially the same dimensions in the first direction (D1).

Description

The present invention relates to a device for subcutaneous administration of a medication.

The device of the present invention falls more particularly into the category of “infusion pumps” as defined by the FDA (Food and Drug Administration) and particularly relates to an ambulatory device, i.e. H. a device configured to be attached to the patient's body to enable subcutaneous administration of a predetermined dose of medication.

The device is attached to the patient's body by a user, for example by a doctor or nurse or by the patient.

In all ambulatory delivery devices, the medication is initially contained in a cartridge housed within the device and is delivered into the patient's body via a fluid pathway.

As used herein, the term "fluid path" is used to mean any element or assembly configured to be connectable at a first end thereof to the cartridge located in the Housed inside a device for subcutaneous administration of a medicament, and which comprises, at an end thereof opposite the aforesaid first end, a needle to be inserted into the patient's body in order to transfer the medicament from the cartridge into the patient's body via the needle. Ambulatory administration devices that consist of two modules that can be coupled to one another are known. One of these modules includes, among other things, the cartridge containing the medication to be administered and the other module includes, among other things, a control unit of the device and the battery for powering the control unit.

In order to enable administration of the medication and avoid damage to one or both of the aforementioned modules, it is necessary that these modules are correctly coupled to one another.

It is therefore known to provide devices in which the two modules have a complementary shape, such as those in US 10737016B2 described device.

The Applicant has observed that there is a trend towards miniaturization of the aforementioned devices so as to enable prolonged use of the device on the patient's body while minimizing the overall dimensions. Such miniaturization necessarily implies a reduction in the extent of the surfaces of the two modules on which the user places his or her fingers when he or she has to couple and decouple the two modules. This makes it difficult for users to grip these modules, especially for older people or people with limited limb mobility (for example due to arthritis or Parkinson's).

The applicant also has a problem of this kind with the in US 10737016B2 Device described found. This device includes a reusable module defined by a body having a greater thickness portion and a lesser thickness portion. The outer surfaces of these sections define the respective gripping surfaces.

According to the applicant, the grip of the aforementioned module is not optimal, especially in the section with the smaller thickness. This is due to the reduced surface area of the gripping surface provided in this section.

The applicant has recognized that in order to optimize the grip of the two modules it is expedient for both modules to have opposing gripping surfaces with the same surface area.

• - ein Verabreichungsmodul, das zum Aufnehmen einer Patrone konfiguriert ist, die ein Medikament enthält, das einem Patienten über eine Nadel verabreicht werden soll;
• - ein Steuermodul, das reversibel an das Verabreichungsmodul gekoppelt werden kann und zum Aufnehmen von mindestens einer Steuereinheit und einer Batterie zum Antreiben der Steuereinheit konfiguriert ist;

wobei das Verabreichungsmodul Folgendes umfasst:

• - eine Anwendungsoberfläche, die dazu konfiguriert ist, mit dem Körper des Patienten in Kontakt zu gelangen;
• - zwei gegenüberliegende erste Greifumfangsflächen, die sich entlang einer ersten Richtung parallel zu der Anwendungsoberfläche und entlang einer zweiten Richtung lotrecht zu der Anwendungsoberfläche erstrecken, wobei die beiden ersten Greifumfangsflächen in der zweiten Richtung im Wesentlichen gleiche Abmessungen aufweisen;

wobei das Steuermodul Folgendes umfasst:

• - zwei gegenüberliegende zweite Greifumfangsflächen, die sich entlang der ersten Richtung und entlang der zweiten Richtung erstrecken, wobei die beiden zweiten Greifumfangsflächen in der zweiten Richtung im Wesentlichen gleiche Abmessungen aufweisen;

wobei die beiden ersten Greifumfangsflächen und die beiden zweiten Greifumfangsflächen in der ersten Richtung im Wesentlichen gleiche Abmessungen aufweisen.The present invention therefore relates to a device for subcutaneous administration of a medication, which comprises:

• - an administration module configured to receive a cartridge containing a medication to be administered to a patient via a needle;
• - a control module reversibly coupled to the delivery module and configured to receive at least one control unit and a battery for powering the control unit;

wherein the administration module comprises:

• - an application interface configured to come into contact with the patient's body;
• - two opposing first gripping peripheral surfaces, which extend along a first direction extend parallel to the application surface and along a second direction perpendicular to the application surface, the two first gripping peripheral surfaces having substantially the same dimensions in the second direction;

wherein the control module includes:

• - two opposing second gripping peripheral surfaces extending along the first direction and along the second direction, the two second gripping peripheral surfaces having substantially the same dimensions in the second direction;

wherein the two first gripping peripheral surfaces and the two second gripping peripheral surfaces have substantially the same dimensions in the first direction.

Such a device allows the user to grip both modules stably and securely, even in the case of particularly miniaturized modules.

The aforementioned device may comprise one or more of the following features, used individually or possibly combined with one another.

Preferably the administration module is a disposable item.

Preferably the control module is reusable.

Preferably, the delivery module includes opposing coupling recesses extending along the first direction near the first gripping peripheral surfaces, and the control module includes opposing coupling projections extending along the first direction near the second gripping peripheral surfaces and configured to engage during coupling of the control module the administration module slides into the coupling recesses. The coupling recesses therefore serve as guides for the coupling projections, whereby a particularly precise and correct mutual coupling of the two modules can be easily achieved.

Preferably, the two first gripping peripheral surfaces are mirrored with respect to a first center plane of the administration module, which extends along the first direction and the second direction. In this way, gripping the administration module is particularly easy.

Preferably, the two second gripping peripheral surfaces are mirrored with respect to a second center plane of the control module, which extends along the first direction and the second direction. In this way, gripping the control module is particularly easy.

Preferably, when the control module is coupled to the delivery module, the first center plane coincides with the second center plane.

Preferably, the delivery module includes a third peripheral surface extending between the two first gripping peripheral surfaces along the second direction and along a third direction parallel to the application surface and perpendicular to the first direction. Preferably, the control module includes a fourth peripheral surface that extends between the two second gripping peripheral surfaces along the second direction and the third direction. Preferably, the fourth peripheral surface is parallel to the third peripheral surface when the control module is coupled to the delivery module.

In a preferred embodiment of the device of the present invention, the sum of the dimensions of each of the first gripping peripheral surfaces and each of the second gripping peripheral surfaces along the first direction is smaller than the dimension of the third peripheral surface and the fourth peripheral surface along the third direction. In this case, the device has a main dimension along the third direction, i.e. H. along a direction substantially orthogonal to that of the opposing gripping surfaces, thereby eliminating the need for users with limited limb mobility to bring the thumb and index finger together to safely and stably manipulate the device.

Preferably, the third peripheral surface and the fourth peripheral surface have substantially the same dimensions in the third direction.

Preferably, the delivery module includes a first interface and the control module includes a second interface that has a substantially opposite shape to the first interface and is configured to face the first interface when the control module is coupled to the delivery module. Providing oppositely shaped interfaces on the two modules encourages the user to establish the correct relative alignment of the two modules before coupling them together.

Preferably, the first interface comprises a first interface portion extending from one of the first gripping peripheral surfaces extends to the other first gripping peripheral surface. Preferably, the first interface section has a concave profile.

Preferably, the second interface includes a second interface portion configured to face the first interface portion when the control module is coupled to the delivery module.

Preferably, the second interface section has a convex profile.

The concave and convex shapes of the portions of the interfaces of the delivery module and the control module are particularly suitable for suggesting to the user the correct orientation of the two modules before they are coupled together and to guide the user during the mutual coupling of the two modules.

Preferably, the concave profile is defined by two opposing surfaces parallel to the two first gripping peripheral surfaces and a connecting surface parallel to the third peripheral surface.

Preferably, the convex profile is defined by two opposing surfaces parallel to the two second gripping peripheral surfaces and a connecting surface parallel to the fourth peripheral surface.

In preferred embodiments of the device of the present invention, each of the two opposing surfaces of the concave profile is closer to a corresponding first gripping peripheral surface than to the first center plane of the administration module.

Preferably, each of the two opposing surfaces of the convex profile is closer to the first gripping peripheral surface than to the second center plane of the control module when the control module is coupled to the administration module.

In this way, the concave and convex profiles have a sufficiently wide surface area for the benefit of the user, thereby making it easier to correctly align the two modules before coupling them.

Preferably, the connecting surface of the concave profile and the connecting surface of the convex profile are closer to the third peripheral surface than to a median plane of the device extending along the second direction and the third direction when the control module is coupled to the delivery module.

In other words, the connecting surface of the concave profile is closer to the third peripheral surface than to the aforementioned central plane and the connecting surface of the convex profile is further from the fourth peripheral surface than to the aforementioned central plane when the control module is coupled to the delivery module.

Preferably, the first interface portion is defined in an upper portion of the delivery module and the second interface portion is defined in an upper portion of the control module.

In the present description and in the following claims, the term "upper portion" is used to indicate a portion of the delivery module which, when the delivery module is attached to the patient's body, is further from the application surface than from the cartridge, and one Portion of the control module which, when the control module is coupled to the administration module and the device thus assembled is attached to the patient's body, is further from the application surface than from the control unit and / or the battery for powering the control unit.

Preferably, the first interface includes a first circular portion and the second interface includes a second circular portion configured to overlap the first circular portion when the control module is coupled to the delivery module. These circular sections are configured to allow a drive rotor provided in the second circular section in the control module to rotatably actuate a magnet rotor provided in the first circular section in the administration module through magnetic coupling.

Preferably, the first circular portion defines a recess in the delivery module and the second circular portion defines a projection in the control module. In this way, precise alignment between the aforementioned rotors is achieved.

Preferably, the first interface comprises a second interface portion substantially parallel to the application surface.

In this specification and in the following claims, a surface is intended to be “substantially parallel” to another when each of the two surfaces extends in a plane parallel to the plane in which the other surface extends, and if at least one of the two surfaces comprises sections of flat surfaces which are in different planes and parallel to the other surface or to sections of flat surfaces Surfaces of the other surface are arranged.

Preferably, the first interface includes a third interface portion extending from the second interface portion of the first interface away from the application surface to the first interface portion of the first interface.

Preferably, the first interface section and/or the second interface section and/or the third interface section of the first interface have substantially the same dimensions in the third direction.

Preferably, at least one seal is inserted between at least a portion of the first interface and at least a portion of the second interface. This is done to ensure the tightness of the coupling between the two modules.

Preferably, the control module has a color that is different from that of the delivery module to allow the user to immediately recognize each of the two modules.

Preferably, the control module has a surface finish that is different from that of the delivery module. This also makes it easier for the user to recognize each of the two modules.

• - 1 eine perspektivische Ansicht einer Vorrichtung zur subkutanen Verabreichung eines Medikaments gemäß der vorliegenden Erfindung zeigt;
• - 2 eine perspektivische Ansicht eines Teils der Vorrichtung von 1 zeigt;
• - 3 eine Unteransicht des Teils von 2 zeigt;
• - 4 eine Schnittansicht des Teils von 2 zeigt;
• - 5 eine perspektivische Ansicht eines anderen Teils der Vorrichtung von 1 zeigt;
• - 6 eine Unteransicht des Teils von 5 zeigt;
• - 7 eine Seitenansicht des Teils von 5 zeigt;
• - 8 eine Vergrößerung einiger Komponenten der Vorrichtung von 1 in einer ersten Betriebskonfiguration zeigt, wobei einige Teile verborgen sind, um andere Teile hervorzuheben;
• - 9 eine Vergrößerung einiger Komponenten der Vorrichtung von 1 in einer zweiten Betriebskonfiguration zeigt, wobei einige Teile verborgen sind, um andere Teile zu zeigen;
• - 10 eine Vergrößerung einiger Komponenten der Vorrichtung von 1 in einer dritten Betriebskonfiguration zeigt, wobei einige Teile verborgen sind, um andere Teile hervorzuheben.

The features of the present invention will emerge from the following detailed description of some exemplary embodiments thereof, provided by way of non-limiting examples. Such description is made with reference to the accompanying drawings, in which:

• - 1 shows a perspective view of a device for subcutaneous administration of a medicament according to the present invention;
• - 2 a perspective view of part of the device from 1 shows;
• - 3 a bottom view of the part of 2 shows;
• - 4 a sectional view of the part of 2 shows;
• - 5 a perspective view of another part of the device from 1 shows;
• - 6 a bottom view of the part of 5 shows;
• - 7 a side view of the part of 5 shows;
• - 8th an enlargement of some components of the device 1 in a first operating configuration, with some parts hidden to highlight other parts;
• - 9 an enlargement of some components of the device 1 in a second operating configuration, with some parts hidden to show other parts;
• - 10 an enlargement of some components of the device 1 in a third operating configuration, with some parts hidden to highlight other parts.

A device for subcutaneous administration of a medication, the object of the present invention, is in 1 shown schematically and is indicated with reference number 1.

The device 1 comprises an administration module 10, in 2 until 4 shown, and a control module 20, in 5 until 7 shown.

The device 1 is obtained by mutually coupling the administration module 10 and the control module 20. As will become clear in the further course of this description, this coupling is reversible, i.e. H. The two modules 10 and 20 can be decoupled again after coupling.

The administration module 10 includes an inner housing 101 (in 4 shown) configured to hold a cartridge (not shown). The cartridge comprises a cylindrical container made of a plastic or glass material containing a medication to be administered 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 passage of medication from the cartridge to the patient's body. This fluid path includes a needle configured to puncture the septum (hereinafter referred to as the “septal needle”), a skin needle configured to be inserted into the patient's body, and a flexible one Hose that brings the aforementioned needles into fluid communication.

The delivery module 10 further includes a fluid path orifice system (not shown) configured to move the septal needle and/or the cartridge so that the septal needle pierces the septum and enters fluid communication with the interior of the cartridge so that the medication can be withdrawn therefrom .

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

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

The administration module 10 is preferably a disposable item. In other words, the delivery module 10 is configured to be attached to the patient's body only once and only for a certain period of time and to administer, in whole or in part, the contents of the cartridge with one or more successive injections, even if spaced apart in time . The delivery module 10 does not provide for refilling or cartridge replacement and is configured to be discarded 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 essentially flat.

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

The application surface 102 includes a base wall 103 that has a substantially rectangular shape with rounded corners. The base wall 103 has two short sides aligned in the first direction D1 and two long sides aligned 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 receiving compartment 101 of the administration module 10. As in 4 As shown, the base wall 103 includes an opening 104 configured to allow positioning of the cartridge in the receiving compartment 101 during assembly of the delivery module 10.

The base wall 103 further includes a transparent member 105, for example made of a transparent plastic material, which is attached to the opening 104 to close it. The transparent member 105 is attached during the assembly phase after the cartridge is inserted into the receiving compartment 101 through the opening 104, and is fixed to 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 surface attached to the base wall 103 and an opposing adhesive surface configured to be attached to the patient's skin. The adhesive layer 106 is configured to be traversed by light. The adhesive layer 106 covers the transparent element 105 and, together with the latter, forms a translucent portion 107 in the application surface 102. The translucent portion 107 is configured so that light from the outside can reach the cartridge in the receiving compartment 101 when the application surface is not in contact with it the patient's body.

The adhesive layer 106 is not transparent and is configured to prevent the cartridge in the storage compartment 101 from being seen through the translucent portion 107. With reference to 1 and 2 The administration module 10 comprises two opposing first gripping peripheral surfaces 110. The first gripping peripheral surfaces 110 extend along the first direction D1 and along the second direction D2.

The first gripping peripheral surfaces 110 border the application surface 102 and partially delimit the receiving compartment 101 on opposite sides.

The first gripping peripheral surfaces 110 are located on opposite short sides of the base wall 103 and essentially form an angle equal to 90° with the base wall 103. The first gripping peripheral surfaces 110 extend along the first direction D1 from a same long side of the base wall 103 toward the opposite long side on the corresponding short sides.

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

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

The first gripping peripheral surfaces 110 have dimensions that are substantially equal to each other along the first direction D1 and the second direction D2. In particular, the two first gripping peripheral surfaces 110 are mirrored with respect to a first center plane of the administration module 10, which extends along the first direction D1 and the second direction D2.

Continue with reference to 1 and 2 the administration module 10 includes a third peripheral surface 111 which extends along the second direction D2 and the third direction D3.

The third peripheral surface 111 borders the application surface 102 and partially delimits the receiving compartment 101.

The third peripheral surface 111 is located on one of the long sides of the base wall 103 and essentially forms an angle equal to 90° with the base wall 103.

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

The third peripheral surface 111 extends along the third direction D3 from one first gripping peripheral surface 110 to the other first gripping peripheral surface 110 on the corresponding long side of the base wall 103.

The third peripheral surface 111 has a dimension that is substantially equal to the dimension of the first gripping peripheral surfaces 110 in the second direction D2.

Each first gripping peripheral surface 110 is connected to the third peripheral surface 111 by a rounded connecting portion.

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

The first interface 115 includes a first interface portion 116. The first interface portion 116 is defined in the portion of the delivery module 10 that is more distal to the application surface 102 along the second direction D2.

The first interface portion 116 extends from one of the first gripping peripheral surfaces 110 to the other of the first gripping peripheral surfaces 110. The first interface portion 116 extends from the third peripheral surface 111 along the first direction D1. The first interface portion 116 partially delimits the receiving compartment 101 on the opposite side with respect to the base wall 103.

The first interface section 116 has a concave profile that is defined by two opposing surfaces 117 parallel to the two first gripping peripheral surfaces 110 and a connecting surface 118 parallel to the third peripheral surface 111.

Each of the two opposing surfaces 117 of the concave profile of the first interface section 116 lies closer to the corresponding first gripping peripheral surface 110 than to the first center plane of the administration module 10.

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

As in 2 shown, the first interface 115 further includes a second interface portion 120 substantially parallel to the application surface 102. The second interface portion 120 is at a smaller distance tion from the application surface 102 positioned as 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 opposite long side to the third peripheral wall 111 towards the third peripheral wall 111.

The second interface section 120 does not extend between the first gripping peripheral surfaces 110.

Continue with reference to 2 the first interface 115 further includes a third interface portion 121 extending from the second interface portion 120 to the first interface portion 116 and from one of the first gripping peripheral surfaces 110 to the other of the first gripping peripheral surfaces 110. The third interface section 121 delimits the receiving compartment 101 on the opposite side with respect to the third peripheral section 111.

The third interface portion 121 includes corresponding ends 122 located on the first gripping peripheral surfaces 110 and a protruding portion 123 located between the ends 122 and protruding on the opposite side with respect to the third peripheral surface 111.

The first interface 115 further includes a first circular portion 124. The first circular portion 124 is configured such that a drive rotor (not shown) provided in the control module 10, a magnet rotor (not shown) provided in the delivery module 10 is, in the first circular section 124 can be rotatably actuated by magnetic coupling when the control module 20 is coupled to the administration 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 defines the receiving compartment 101 on the opposite side with respect to the application surface 102 and defines a recess with respect to the first interface portion 116.

The first interface 115 further includes a viewing window 125 ( 2 and 4 ), which is configured to allow visual inspection of the cartridge when the control module 20 is decoupled from the delivery module 10.

The viewing window 125 is located in the first interface section 116 and thereby overlaps the receiving compartment 101. The viewing window 125 is located parallel to the application surface 102.

The viewing window 125 is located on the opposite side of the receiving compartment 101 with respect to the translucent portion 107. In particular, the viewing window 125 and the translucent portion 107 overlap each other. Specifically, the viewing window 125 and the translucent portion 107 are arranged such that the cartridge is positioned therebetween.

The translucent section 107 is larger than the viewing window 125.

The viewing window 125 is configured to be obscured by the control module 20 when the control module 20 is coupled to the delivery module 10, thereby preventing visual inspection of the cartridge.

The control module 20 preferably has a color and/or material that is different from that of the delivery module 10 to help the user distinguish the two modules during coupling.

The control module 20 in turn includes a housing (not shown) inside which is housed a control unit, which usually consists of a circuit board and is configured to control the administration of the medication from the administration module 10, and a power supply battery configured to power the control unit is.

As in 1 and 5 As shown, the control module 20 includes a top surface 202 that extends substantially parallel to the application surface 102 when the control module 20 is coupled to the delivery module 10.

The top surface 202 has a substantially rectangular shape with rounded corners that mirrors the shape of the base wall 103. Therefore, similar to the latter, the upper surface 202 has two short sides aligned in the first direction D1 and two long sides aligned in the third direction D3.

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

The second gripping peripheral surfaces 210 abut the upper surface 202 and partially define the aforementioned housing on opposite sides.

The second gripping peripheral surfaces 210 are located on opposite short sides of the upper surface 202 and form an angle with the upper surface 202 substantially equal to 90°.

The second gripping peripheral surfaces 210 extend along the first direction D1 from a same long side of the upper surface 202 to the opposite long side on the corresponding short sides.

The second gripping peripheral surfaces 210 extend along the first direction D1 over approximately half the extent of the short sides of the upper surface 202.

The second gripping peripheral surfaces 210 extend away from the upper surface 202 along the second direction D2 with respect to the upper surface 202, i.e. H. towards the application interface 102 when the control module 20 is coupled to the administration module 10.

The second gripping peripheral surfaces 210 have substantially equal dimensions to one another along the first direction D1 and the second direction D2. In particular, the two second gripping peripheral surfaces 210 are mirrored with respect to a second center plane of the control module 20, which extends along the first direction D1 and the second direction D2 and coincides with the first center plane of the administration module 10 when the control module 20 is coupled to the administration module 10 is.

Furthermore, the two first gripping peripheral surfaces 110 and the two second gripping peripheral surfaces 210 have essentially the same dimensions along the first direction D1.

When the control module 20 is coupled to the delivery module 10, each first gripping peripheral surface 110 abuts and is aligned or flush with a corresponding second gripping peripheral surface 210 to define a substantially continuous side surface of the device 1.

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

The fourth peripheral surface 211 adjoins the upper surface 202 and partially delimits the aforementioned housing.

The fourth peripheral surface 211 is located on one of the long sides of the upper surface 202 and forms an angle with the upper surface 202 substantially equal to 90°.

The fourth peripheral surface 211 extends from the upper surface 202 along the second direction D2 away from the upper surface 202, i.e. H. towards the application interface 102 when the control module 20 is coupled to the administration module 10.

The fourth peripheral surface 211 extends along the third direction D3 from one second gripping peripheral surface 210 to the other second gripping peripheral surface 210 on the corresponding long side of the upper surface 202.

The fourth peripheral surface 211 has a dimension in the second direction D2 that is substantially equal to the dimension of the second gripping peripheral surfaces 210.

Every second gripping peripheral surface 210 is connected to the fourth peripheral surface 211 by a rounded connecting section 212.

When the control module 20 is coupled to the delivery module 10, the fourth peripheral surface 211 is arranged substantially parallel to the third peripheral surface 111, on the opposite side to the latter.

The sum of the dimensions of each of the first gripping peripheral surfaces 110 and each of the second gripping peripheral surfaces 210 along the first direction D1 is smaller than the dimension of the third peripheral surface 111 and the fourth peripheral surface 211 along the third direction D3.

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

The second interface 215 has a substantially opposite shape to the first interface 115 and faces away from the top surface 202.

The second interface 215 includes a first interface portion 216 substantially parallel to the upper surface 202. The first interface portion 216 of the control module 20 has a substantially opposite shape to the second interface portion 120 of the delivery module 10 and is configured to face the latter.

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

The first interface portion 216 extends from one of the second gripping peripheral surfaces 210 to the other second gripping peripheral surface 210. The first interface portion 216 adjoins the fourth peripheral surface 211 and extends from the fourth peripheral surface 211 along the first direction D1. The first interface portion 216 partially bounds the aforementioned housing on the opposite side with respect to the upper surface 202.

The second interface 215 further includes a second interface portion 220 placed at a shorter distance from the top surface 202 than the first interface portion 216. The second interface portion 220 has a substantially opposite shape to the first interface portion 116 of the delivery module 10 and is configured so that it is arranged facing the latter.

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 upper surface 202 and along the first direction D1 from the long side opposite the fourth peripheral wall 211 toward the fourth peripheral wall 211.

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

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

Each of the two opposing surfaces 217 of the convex profile of the second interface section 220 lies closer to the corresponding second gripping circumferential surface 210 than to the second center 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 peripheral surface 111 than to a center plane of the device 1 which extends along the second direction D2 and the third direction D3, when the control module 20 is coupled to the administration module 10.

The second interface 215 further includes a third interface portion 221 that extends from the second interface portion 220 to the first interface portion 216 and from one of the second gripping peripheral surfaces 210 to the other of the second gripping peripheral surfaces 210. The third interface portion 221 delimits the aforementioned housing on the opposite side with respect to the fourth peripheral portion 211.

The third interface portion 221 of the control module 20 has a substantially opposite shape to the third interface portion 121 of the delivery module 10 and is configured to face the latter.

The third interface portion 221 includes corresponding ends 222 located on the second gripping peripheral surfaces 210 and a recessed portion 223 located between the ends 222 and recessed toward the fourth peripheral surface 211.

The second interface 215 further includes a second circular portion 224. The second circular portion 224 of the control module 20 has a substantially opposite shape to the first circular portion 124 of the delivery module 10 and is configured to face the latter.

The first circular section 124 and the second circular section 224 are configured to provide precise alignment between the drive rotor provided in the control module in the second circular section 224 and the magnet rotor provided in the delivery module 10 in the first circular Section 224 is provided when the control module 20 is coupled to the administration module 10.

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

The second interface 215, in particular the first interface section 220 of the second interface 215, is configured so that it Viewing window 125 is covered when the control module 20 is coupled to the delivery module 10 to prevent visual inspection of the cartridge.

One or more seals (not shown) are inserted between at least a portion of the first interface 115 and at least a portion of the second interface 215 to ensure the tightness of the coupling between the delivery module 10 and the control module 20.

As in 2 shown, the delivery module 10 includes opposing coupling recesses 130 extending along the first direction D1. The coupling recesses 130 are located near the first gripping peripheral surfaces 110.

In particular, the coupling recesses 130 are located on the first interface section 116. The coupling recesses 130 extend starting from the opposite surfaces 117 of the concave profile of the first interface section 116 towards the first gripping peripheral surfaces 110.

As in 5 As shown, the control module 20 includes opposing coupling projections 230 extending along the first direction D1. The coupling projections 230 are configured to slide into the coupling recesses 130 during coupling of the control module 20 to the administration module 10 so as to guide their sliding along the coupling direction A1. The coupling projections 230 are located near the second gripping peripheral surfaces 210.

As in 6 and 7 As shown, the control module 20 includes a locking projection 300. The locking projection 300 extends from the second interface 215 of the control module 20 along a direction perpendicular to the coupling direction A1 and parallel to the second direction D2. In particular, the locking projection 300 extends from the first interface portion 216 of the second interface 215 along the aforementioned direction. When the control module 20 is coupled to the delivery module 10, the locking projection 300 protrudes toward the application surface 102.

The locking projection 300 includes a short shaft 301 that extends from the second interface 215 along the aforementioned extension direction and has an end 302 and a tooth 303 that extends from the end 302 parallel to the coupling direction A1.

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

The locking projection 300 is located on the second center plane of the control module 20. The control module 20 further comprises a locking projection 310 which extends along a direction parallel to the direction of the locking projection 300. In particular, the closure projection 310 extends from the second interface 215 along the second direction. Specifically, the locking projection 310 extends from an edge of the mutual connection of the second interface 215 and the fourth peripheral surface 211, flush with the fourth peripheral surface 211.

The locking projection 310 is located at the second center plane of the control module 20 and is spaced from the locking projection 300 along the coupling direction A1. As in 2 , 8-10 As shown, the delivery module 10 includes a receptacle 400 configured to cooperate with the locking projection 300 during coupling between the delivery module 10 and the control module 20.

The receptacle 400 includes an inlet 401 configured to receive the locking projection 300. The inlet 401 is located on the first interface 115, in particular on the second interface section 120 of the first interface 115, on one of the long sides of the base wall 103.

The receptacle 400 further includes an internal volume 402 configured to receive the locking projection 300 at the end of the coupling between the delivery module 10 and the control module 20. The inner volume 402 borders the inlet 401 along the coupling direction Ai

The receptacle 400 also includes a coupling section 403 that overlaps the inlet 401 and the internal volume 402 ( 2 ).

The coupling section 403 is defined between two opposing guide surfaces 404 extending along the coupling direction Ai from the inlet 401 to the internal volume 402 cken. 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 border on the second interface section 121 of the first interface 115.

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

The coupling section 403 further comprises a stop surface 405, which extends perpendicular to the coupling direction A1 and faces 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 adjoins the second interface portion 121 of the first interface 115 and defines an end stop for the locking projection 300 along the coupling direction A1.

The receptacle 400 further includes a hooking surface, not shown in the accompanying figures, which is configured to be disposed abutting the hooking portion 305 of the locking projection 300 when the locking projection 300 is received in the interior volume 402, as in the configuration from 10 . The hooking surface is substantially parallel to the application surface 102 and faces the application surface 102.

As in 8-10 shown, the administration module 10 further includes a slider 410 that is associated with the receptacle 400 and can be slidably moved between a first position and a second position along a maneuvering direction M1 perpendicular to the coupling direction A1 and parallel to the application surface 102. In particular, the maneuvering direction M1 is parallel to the third direction D3.

The slider 410 includes a main body 411 which is slidably mounted in the receptacle 400.

The main body 411 includes an insert portion 412 which is shaped to block the inlet 401 when the slider 410 is in the first position and not to block the inlet 401 when the slider 410 is in the second position. When the slider 410 is in the first position, the insert portion 412 is arranged on the coupling portion 403. When the slider 410 is in the second position, the insert portion 412 is disposed in a position adjacent to the coupling portion 403.

The insert portion 412 includes a pressing surface 413 that faces the inlet 401 when the slider 410 is in the first position. The pressing surface 413 is oriented obliquely with respect to the coupling direction A1. In particular, the pressing surface 413 is aligned in a plane perpendicular to the application surface 102 and is oriented obliquely with respect to the third direction D3 at an angle which is preferably between 30° and 60°, more preferably between 40° and 50°, for example equal about 45°.

The insert portion 412 further includes a locking surface 414 that faces the interior volume 402 when the slider 410 is in the first position. The locking surface 414 is oriented perpendicularly with respect to the coupling direction A1. The locking surface 414 is parallel to the stop surface 405. In particular, the locking surface 414 extends along the second direction D2 and the third direction D3.

The slider 410 further includes a maneuvering section 416, shown in 3 , which can be manually operated along the maneuvering direction M1 to move the slider 410 from the first position to the second position. The maneuvering portion 416 protrudes from the main body 411 in the second direction D2 toward the application surface 102 until it is disposed outside the receptacle 400 through an opening 417 formed in the application surface 102.

The maneuvering portion 416 is arranged substantially flush with the application surface 102, includes a friction surface 418 parallel to the application surface 102, and is configured to allow a user to move the slider 410 from the first position to the second position parallel to the friction surface 418 his/her finger allowed. Preferably, the friction surface 418 has a high roughness or surface asperities configured to increase friction with the user's finger.

The maneuvering section 416 is positioned on the application surface 102 such that when the device 1 is attached to the patient's body through the application surface 102, the maneuvering section 416 is inaccessible and cannot be reached. An elastic member 419 is inserted between a first shoulder 420 formed in the receptacle 400 and a second shoulder 421 formed in the slider 410 so as to counteract an elastic force to exercise the slider 410. Preferably the elastic element 419 is a spring.

When the slider 410 is in the first position, the elastic force of the elastic member 419 holds it in the first position both before the coupling between the administration module 10 and the control module 20 and at the end of the coupling between the administration module 10 and the control module 20. In order to move the slider from the first position to the second position, the user must exert such a force along the maneuvering direction M1 on the maneuvering section 416 that the elastic force of the elastic member 419 is overcome. When the slider is in the second position, the elastic member 419 pushes it toward the first position.

To couple the control module 20 to the administration module 10, the two modules are moved toward each other until the coupling projections 230 are inserted into the coupling recesses 130 and the locking projection 300 is inserted into the receptacle 400 through the inlet 401. At this point, the control module 20 is pushed along the coupling direction A1 towards the administration module 10.

As in 8-10 shown, the pressing portion 304 of the locking projection 300 abuts the pressing surface 413 of the slider 410, which is in the first position. Thanks to the oblique orientation of the pressing surface 413, the pressing portion 304, while moving along the coupling direction A1, shifts the slider 410 from the first position to the second position and slides onto the pressing surface 413, thereby achieving the elastic pressing provided by the elastic member 419 is exerted on the slider 410, is overcome. In this way, the inlet 401 becomes accessible and the locking projection 300 can enter the internal volume 402. Alternatively, the slider 410 may be moved from the first position to the second position by manually operating the maneuvering portion 416. By continued movement along the coupling direction A1, the pressing section 304 detaches from the pressing surface 413 and the locking projection 300 reaches the internal volume 402. The slider 400 can now freely return to the first position due to the restoring effect exerted by the elastic element 419 , so that the insert portion 412 of the slider 410 blocks the inlet 401.

The locking projection 300, when accommodated 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 any direction in the coupling direction A1. Furthermore, when the locking projection 300 is received in the internal volume 402, the hooking portion 305 overlaps the hooking surface and prevents relative movements of the administration module 10 and the control module 20 perpendicular to the application surface 102.

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

In this configuration, the closure projection 310 is positioned to close the inlet 401, as shown in 10 shown.

QUOTES INCLUDED IN THE DESCRIPTION

This list of documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US 10737016 B2 [0007, 0009]

Claims (16)

Device (1) for subcutaneous administration of a medication, comprising: - an administration module (10) configured to receive a cartridge containing a medication to be administered to a patient via a needle; - a control module (20) reversibly coupled to the delivery module (10) and configured to receive at least one control unit and a battery for powering the control unit; wherein the administration module (10) comprises: - an application surface (102) configured to come into contact with the patient's body; - two opposite first gripping peripheral surfaces (110), which extend along a first direction (D1) parallel to the application surface (102) and along a second direction (102) perpendicular to the application surface (102), the two first gripping peripheral surfaces (110) have substantially the same dimensions in the second direction (D2); wherein the control module (20) comprises: - two opposing second gripping peripheral surfaces (210) which extend along the first direction (D1) and along the second direction (D2), the two second gripping peripheral surfaces (210) having substantially the same dimensions in the second direction (D2); wherein the two first gripping peripheral surfaces (110) and the two second gripping peripheral surfaces (210) have substantially the same dimensions in the first direction (D1). Device (1) according to Claim 1 , wherein the delivery module (10) includes opposing coupling recesses (130) extending along the first direction (D1) near the first gripping peripheral surfaces (110) and the control module (20) includes opposing coupling projections (230) extending along the first direction (D1) extend near the second gripping peripheral surfaces (210) and are configured to slide into the coupling recesses (130) during coupling of the control module (20) to the administration module (10). Device (1) according to one of the preceding claims, wherein: - the two first gripping peripheral surfaces (110) are mirrored with respect to a first central plane of the administration module (10), which extends along the first direction (D1) and the second direction (D2); - the two second gripping peripheral surfaces (210) are mirrored with respect to a second central plane of the control module (20), which extends along the first direction (D1) and the second direction (D2); wherein when the control module (20) is coupled to the delivery module (10), the first center plane coincides with the second center plane. Device (1) according to one of the preceding claims, wherein: - the administration module (10) comprises a third peripheral surface (111) which is between the two first gripping peripheral surfaces (110) along the second direction (D2) and along a third direction (D3) which is parallel to the application surface (102) and perpendicular to the first direction (D1); - the control module (20) comprises a fourth peripheral surface (211) which extends between the two second gripping peripheral surfaces (210) along the second direction (D2) and the third direction (D3), the fourth peripheral surface (211) being parallel to the third peripheral surface (111) when the control module (20) is coupled to the administration module (10); wherein the sum of the dimensions of each of the first gripping peripheral surfaces (110) and each of the second gripping peripheral surfaces (210) along the first direction (D1) is smaller than the dimension of the third peripheral surface (111) and the fourth peripheral surface (211) along the third direction (D3) is. Device (1) according to one of the preceding claims, wherein the administration module (10) comprises a first interface (115) and the control module (20) comprises a second interface (215) which has a substantially opposite shape to the first interface (115). and is configured to face the first interface (115) when the control module (20) is coupled to the delivery module (10); and where - the first interface (115) comprises a first interface portion (116) which extends from one of the first gripping peripheral surfaces (110) to the other first gripping peripheral surface (110) and has a concave profile; - the second interface (215) comprises a second interface portion (220) that has a convex profile and is configured to face the first interface portion (115) when the control module (20) is coupled to the administration module (10). is. Device (1) according to Claim 5 , wherein: - the concave profile is defined by two opposing surfaces (117) parallel to the two first gripping peripheral surfaces (110) and a connecting surface (118) parallel to the third peripheral surface (111); - The convex profile through two opposing surfaces (217) parallel to the two second grippers peripheral surfaces (210) and a connecting surface (218) are defined parallel to the fourth peripheral surface (211). Device (1) according to Claim 6 , when dependent on Claim 3 , wherein: - each of the two opposing surfaces (117) of the concave profile is closer to a corresponding first gripping peripheral surface (110) than to the first central plane of the administration module (10); - Each of the two opposing surfaces (217) of the convex profile is closer to the first gripping peripheral surface (110) than to the second central plane of the control module (20) when the control module (20) is coupled to the administration module (10). Device (1) according to Claim 6 or 7 , wherein the connecting surface (118) of the concave profile and the connecting surface (218) of the convex profile lie closer to the third peripheral surface (111) than to a central plane of the device (1) which is along the second direction (D2) and the third Direction (D3) extends when the control module (20) is coupled to the administration module (10). Device (1) according to one of the Claims 5 until 8th , wherein the first interface portion (116) is defined in an upper portion of the delivery module (10) and the second interface portion (220) is defined in an upper portion of the control module (20). Device (1) according to one of the Claims 5 until 9 , wherein the first interface (115) includes a first circular portion (124) and the second interface (215) includes a second circular portion (224) configured to overlap the first circular portion (124) when the Control module (20) is coupled to the administration module (10). Device (1) according to Claim 10 , wherein the first circular portion (124) defines a recess in the delivery module (10) and the second circular portion (224) defines a projection in the control module (20). Device (1) according to one of the Claims 5 until 11 , wherein the first interface (115) has a second interface portion (120) that is substantially parallel to the application surface (102), and a third interface portion (121) that extends from the second interface portion (120) away from the application surface (102 ) extends up to the first interface section (116). Device (1) according to Claim 12 , wherein the first interface portion (116), the second interface portion (120) and the third interface portion (121) of the first interface (115) have substantially the same dimensions in the third direction (D3). Device (1) according to Claim 12 or 13 , which comprises at least one seal inserted between at least a portion of the first interface (115) and at least a portion of the second interface (215). Device (1) according to any one of the preceding claims, wherein the control module (20) has a color different from that of the administration module (10). Device (1) according to one of the preceding claims, wherein the control module (20) has a surface finish that differs from that of the administration module (10).

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