FR3142676A3 - DEVICE FOR SUBCUTANEOUS DRUG DELIVERY - Google Patents

Abstract

A device (1) for subcutaneous drug delivery includes an injection needle (34) configured to inject the drug into a patient when the device (1) is applied to the patient's skin , the injection needle (34) being movable between a rest position in which it is entirely disposed inside the device (1) and an injection position in which it projects at least partially from the device ( 1) through a through opening (12a) of the device (1). The device (1) further comprises a protective element (70) arranged around the injection needle (34) and movable between a first operating position in which the protective element (70) projects from the device (1) and a second operating position in which the protective element (70) does not protrude from the device (1). A flexible sleeve (80) is associated in a watertight manner with the device (1) around the through opening (12a). This flexible sleeve (80) is associated in one piece with the protective element (70). Figure for abstract: 7

Description

DEVICE FOR SUBCUTANEOUS DRUG DELIVERY Technical field of the invention

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

In particular, the device of the present invention falls into the category of "infusion pumps" as defined by the FDA (US Food and Drug Administration) and relates, more particularly, to a device of the type that can be worn on one's person, that is, configured to be applied to a patient's body to enable subcutaneous administration of a predetermined dose of medication. The application of the device to the patient's body is carried out by a user, for example a doctor or a nurse or the patient.

Technical background

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

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

In the present application, the term "fluidic path" is used to designate any element or set of elements which is configured to be connected, at a first end thereof, to the cartridge housed inside the device. administration and comprising, at one end thereof opposite the first end mentioned above, an injection needle intended to be inserted into the body of the patient to enable transfer of the medicine from the cartridge to the body of the patient.

Typically, the cartridge comprises a cylindrical container, made of a plastic or glass material, a piston which can slide inside the container to push the medication out of the container and a pierceable septum which guarantees the sterility of the container until the beginning of therapy administration.

Typically, the fluid path includes a piercing needle configured to pierce the pierceable septum of the cartridge and a flexible tube that places the piercing needle in fluid communication with the injection needle.

In such devices, the cartridge container is kept closed by the pierceable septum until drug delivery is required. When such administration is necessary, the pierce needle pierces the pierceable septum and opens the fluid pathway, allowing the medication to reach the patient first through the pierce needle, then through the flexible tubing and ultimately by the injection needle, due to the thrust exerted by the piston on the medicine inside the container.

Obviously, the administration of the drug to the patient takes place after the injection needle is inserted into the patient's body.

Such insertion occurs following activation of a movement mechanism configured to move the injection needle between a rest position in which the injection needle is fully disposed within the device and a position injection in which the injection needle protrudes from the device and penetrates the skin of the patient.

The displacement mechanism may also be configured to extract the injection needle from the patient's skin at the end of therapy delivery by returning it within the device.

The Applicant observed that in applications where continuous drug release is required, subcutaneous delivery devices must be worn by the patient for extended periods of time. It is therefore necessary that these devices be waterproof so as not to interfere with the patient's daily life in activities such as taking a shower, bathing, doing sports, swimming, etc. In fact, if water, or even sweat, gets inside the device, the electronic and mechanical components inside the device could suffer from malfunctions or breakdowns.

The Applicant has examined all the critical points where water and/or sweat can penetrate inside the device and verified that the most critical point in terms of waterproofing is the one in which the opening is provided through which the injection needle exits the device for the administration of therapy.

WO 2021/252971A2 describes the use of a watertight barrier positioned above the through opening mentioned above.

US 2020/0222624A1 and US 2013/0060233A1 describe the use of a membrane extending inside the device around the injection needle when the needle is entirely arranged inside the device. The membrane maintains a sterile environment around the injection needle. When the injection needle exits the device, the membrane is folded like bellows inside the device.

The Applicant has observed that many devices are conveniently provided with protective elements arranged around the through opening through which the injection needle exits for administration of therapy. These protective elements are movable between a retracted position in which they are arranged inside the device and an extended position in which they are extracted from the device to be arranged around the injection needle when the device is removed from the device. skin of the patient, so as to protect the patient from accidental contact with the injection needle at the end of the administration of the therapy. Examples of devices of the type described above are disclosed in WO 2002/02165A2 and US 10881811B2.

The Applicant assumes that, even in devices equipped with protective elements, appropriate measures should be provided to prevent water, sweat and more generally powders and liquids from entering the device.

The technical problem solved by the present invention is therefore to provide a solution suitable for preventing the entry of water, sweat and more generally powders and liquids into devices provided with protective elements which protrude from the device when the device is not applied to the patient's skin and which are housed in the device when the device is applied to the patient's skin.

The Applicant thought that this technical problem could be solved by arranging around the protective element a flexible sleeve capable of moving in synchronization with the protective element and by associating this flexible sleeve with the device in a watertight manner. , and therefore also powder-tight.

The present invention therefore relates to a device for subcutaneous administration of a drug, comprising:
- an injection needle configured to inject the medication into a patient when the device is applied to the skin of the patient, the injection needle being movable between a rest position in which the injection needle is fully disposed to the interior of the device and an injection position in which the injection needle protrudes at least partially from the device through a through opening of the device;
- a protective element arranged around the injection needle and movable between a first operating position in which the protective element projects from the device and a second operating position in which the protective element does not protruding from the device;
- a flexible sleeve associated in a watertight manner with the device around said through opening and associated in one piece with the protective element.

By being integrally associated with the protective element, the flexible sleeve moves with the protective element between the first operating position mentioned above in which the flexible sleeve and the protective element extend outside the device and the second operating position mentioned above in which the flexible sleeve and the protective element are housed inside the device. Consequently, by associating the flexible sleeve with the device around the protective element so as to be watertight, the impermeability of the device and the sealing also against powders at the level of the through opening through which the injection needle comes out for the administration of therapy are ensured.

Preferred characteristics of the device of the invention are described below. Each of these features can be provided individually or in combination with the others.

Preferably, the protective element comprises a base provided with a through hole to allow the passage of the injection needle during movement of the injection needle between the rest position and the injection position.

Preferably, said base comprises a raised edge which defines in the protective element a recess which accommodates the tip of the injection needle both when the protective element is in the second operating position and the needle injection is in the rest position and when the protection element is in the first operating position and the injection needle is in the injection position. The raised edge surrounds the tip of the injection needle and prevents the user from contacting the tip if the injection needle is outside the device and the device is not applied to the patient's skin.

Preferably, the flexible sleeve is associated in one piece with said base.

Preferably, the flexible sleeve is defined by a membrane having an internal surface which is integrally associated with the external surface of said base.

Preferably, the membrane is of the bellows type and has a substantially conical or frustoconical shape. In this way, the membrane can be folded telescopically inside the device when the device is applied to the patient's skin, thus occupying an extremely limited space, benefiting the compactness of the device.

In an optional embodiment, the flexible sleeve is not configured to close the through-hole in the base of the protective element. In this case, said through hole is sealed in a sealed manner by a pierceable septum configured to be pierced by the injection needle when the injection needle moves from the rest position to the injection position.

Preferably, the flexible sleeve has a base surface integrally associated with the base of said protective element.

More preferably, the base surface of the flexible sleeve covers the through hole of the base of the protection member and can be pierced by the injection needle when the injection needle moves from the rest position to the position injection. In this case, the flexible sleeve continuously covers the protective element also covering the through opening of the device through which the injection needle emerges and it is this same injection needle which pierces the base surface of the flexible sleeve when it emerges from the protective element and, therefore, from the flexible sleeve. It is therefore not necessary to worry about compensating for any dimensional differences between the through hole and the septum. Furthermore, in this case, the flexible sleeve, in addition to ensuring sealing at the level of the through hole created by the injection needle, retains inside the device any drop of medication released by the device before the administration of the drug.

Preferably, the flexible sleeve is entirely arranged inside the device when the protective element is in its second operating position, so as not to be bulky when the device is applied to the patient's skin.

Preferably, the device comprises a compression ring welded to an application surface of the device at said through opening.

Preferably, said flexible sleeve comprises an annular end portion which is interposed between said application surface and said compression ring. The latter thus firmly forces the flexible sleeve onto the device by compression. Therefore, the desired seal at the through opening of the device is achieved due to the compression of the annular end portion on the application surface of the device by the compression ring.

Preferably, said compression ring is welded by ultrasonic welding.

Preferably, said flexible sleeve is made of a silicone material for medical use.

Brief description of the figures

Other characteristics and advantages of the present invention will become clearer on reading the following detailed description of preferred embodiments thereof, made with reference to the appended drawings and given for informational and non-limiting purposes. In these drawings:

- there is a perspective view of a device according to the present invention;

- there is an exploded perspective view of a first embodiment of a module of the device of the ;

- there is an exploded perspective view of another module of the device of the ;

- there is a bottom perspective view of the device of the fitted with a patch;

- there is a bottom perspective view of the device of the after removing a protective layer from the patch;

- there is a sectional top view of the module of the in an initial configuration of the device of the ;

- there is a perspective sectional view of the device of the before being applied to the patient's skin;

- there is a perspective sectional view of the device of the just after being applied to the patient's skin;

- there represents an enlargement of a detail of the module of the in an operating configuration of the device subsequent to that of the ;

- there is a side sectional view of part of the module of the in an initial configuration of the device of the ;

- there is a sectional side view of the part of the in an operating configuration of the device subsequent to that of the and corresponding to that of the ;

- there is a side sectional view of another detail of the module of the in an initial configuration of the device of the ;

- there is a side sectional view of the detail of the in an operating configuration of the device subsequent to that of the and corresponding to that of Figures 9 and 11;

- there is a perspective sectional view of certain components of the module of the in an operating configuration of the device subsequent to that of the and corresponding to that of Figures 9, 11 and 13;

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

- there is a perspective sectional view of some of the components of Figures 15 and 16 in an operating configuration of the device subsequent to that of the ;

, , And - Figures 18 to 21 show an enlargement of another part of the module of the in four subsequent operating configurations of the device of the ;

- there is a side sectional view of part of the device of the in an operating configuration of the device subsequent to that of the ;

- there is a side sectional view of the device of the in a possible operating configuration thereof in which said device is not applied to the patient's skin;

- there is a perspective view of a component of the device of the ;

- there is a perspective view of part of a third embodiment of the module of the when the device is not applied to the patient's skin;

- there is a perspective view of the part of the just after applying the device to the patient's skin;

- there is a top view of the part of the in the operating configuration of the ;

- there is a perspective view of the part of the in an operating configuration of the device subsequent to that of Figures 26 and 27;

- there is a top view of the part of the in the operating configuration of the ;

, And - Figures 30 to 32 are perspective views of the part of the in three operating configurations of the device subsequent to that of the ;

- there is a sectional side view of the part of the in the operating configuration of the ;

- there is a sectional side view of the part of the in the operating configuration of the ;

- there is a time diagram relating to different operating stages implemented by the device of the present invention during its use.

Detailed description of the invention

On the , a device of the type that can be worn on one's person for the subcutaneous administration of a medication according to the present invention is indicated by the reference numeral 1.

The device 1 comprises an administration module 2, shown on the , and a control module 3, shown on the .

Device 1 is obtained by mutually coupling the administration module 2 and the control module 3. This coupling is reversible, that is to say that the two modules 2 and 3 can be decoupled after having been coupled.

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

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

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

A housing compartment 6 is defined between the lower body 4 and the upper cover 5. The housing compartment 6 contains a control unit 7, generally made of a printed circuit and configured to control the delivery of the drug from the module administration unit 2, an energy supply battery 8 configured to supply energy to the control unit 7 and a motor 9 which rotates a magnetic drive rotor 9a.

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

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

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

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

As shown on the , the main body 11 comprises an application surface 12 configured to come into contact with the patient's body.

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

The application surface 12 comprises a through opening 12a ( ).

Referring again to the , the housing compartment 10 is configured to house a plurality of components, including a cartridge 20 and a fluid path 30.

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

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

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

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

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

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

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

With reference to Figures 10 and 11, the movement of the support member 42 is achieved by providing a movement transmission member 50 comprising a worm screw 54 engaged with a rack 51 at a part coupling 53 of the rack 51. The latter is in turn coupled to a drive member 48 which can rotate around an axis of rotation X and which can be coupled to the support member 42.

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

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

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

The coupling part 48c comprises teeth 48f engaging with the coupling part 52 of the rack 51 and extending circumferentially over a predetermined angle less than 360°, more preferably less than 180°, for example equal to approximately 90 °.

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

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

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

Until the drive member 48 rotates around the axis of rotation between the stop element 43 and the exterior surface of the peripheral wall 48d. This mutual stop counteracts the pushing action exerted by the elastic element 46 on the support member 42 ( ).

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

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

In this second embodiment, the turns of the torsion spring which defines the elastic element 46 are arranged around an axis orthogonal to the axis of rotation torsion spring of the embodiment described above.

Furthermore, in the embodiment of Figures 15 to 17, the stop element 43 is defined by a rectilinear rib 43b arranged on the exterior lateral surface of the body 42a.

On the , the drive member 48 is shown in a first angular position, while on the , the drive member 48 is shown in a second angular position. These angular positions are functionally similar to those of Figures 10 and 11 of the first embodiment described above.

On the , the drive member 48 is shown in another angular position posterior to that of the . When the drive member reaches the angular position of the , the rib 43b, which previously entered the zone 48g of the coupling part 48b ( ), is located at an interior surface of the peripheral wall 48d and cannot leave the zone 48g. In this way, the drive member 48 hinders a possible tendency of the support member 42 to move from the second operating position to the first operating position.

As shown on the and Figures 18 to 23, the administration module 2 also includes an injection needle moving mechanism 60, configured to move the injection needle 34, at the start of the administration of the therapy from 'a rest position, in which the injection needle 34 is entirely arranged inside the device 1 and does not project from the plane P of the device 1 (Figures 18 and 19), towards an injection position in which the injection needle 34 projects at least partially from the plane P of the device 1 (FIGS. 20 and 22) through the through opening 12a, and at the end of the administration of the therapy from the injection position towards the rest position ( ).

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

The support member 62 has a substantially cylindrical shape and has an outer side surface 62a to which the end portion 36b of the flexible tube 36 is connected.

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

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

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

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

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

The compression spring 65 is arranged between the intermediate cover 15 and an interior surface 63a of the thrust member 63 facing opposite the plane P.

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

Compression spring 65 has an elastic constant greater than that of compression spring 64.

The injection needle moving mechanism 60 has two main operating configurations.

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

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

The thrust member 63 has a substantially cylindrical shape and is movable in rotation around the axis D of a first angular position ( ) in which the injection needle moving mechanism 60 is in the first operating configuration at a second angular position ( ) in which the injection needle moving mechanism 60 is in the second operating configuration.

A stop element 62c (visible on the ) extends from the outer side surface 62a of the support member 62 towards the thrust member 63 and a thrust element 63c extends from an outer side surface 63b of the thrust member 63 towards the support member 62.

When the injection needle moving mechanism 60 is in the first operating configuration, the pushing element 63c is coupled to the stop element 62c and exerts a pushing action against the latter ( ), while, when the injection needle moving mechanism 60 is in the second operating configuration, the pushing element 63c is decoupled from the stop element 62c ( ).

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

The instruction member 61 has a substantially cylindrical shape and is driven to rotate around the axis D initially from an angular stopping position ( ) in which the thrust member 63 is in the first angular position and the instruction member 61 is coupled to the thrust member 63 and maintains the latter in the first service position, towards a first angular position of liberation ( ) in which the thrust member 63 is always in the first angular position and the instruction member 61 is decoupled from the thrust member 63 allowing the thrust member 63 to reach the second operating position.

A projecting member 63d extends from the outer side surface 63b of the thrust member 63 on the opposite side to the thrust member 63c.

The instruction member 61 comprises an abutment surface 61e which, when the instruction member 61 is in the angular stopping position, abuts against the projecting element 63d (Figures 18 and 19).

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

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

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

Then, the instruction member 61 is rotated around the axis D from the first angular release position ( ) to a second angular release position ( ) in which the thrust member 63 is in the second angular position. This rotation causes a similar rotation of the thrust member 63 because the projecting element 63d is housed in the seat 61a.

Housing the projecting element 63d in the seat 61a therefore allows both the transition of the thrust member 63 from the first service position to the second service position due to the thrust exerted on the member thrust 63 by the compression spring 65, with the consequent extraction of the injection needle 34 from the device 1 ( ), and the transfer of the rotary movement of the instruction member 61 to the pushing member 63 when it is in the second service position ( ), with the consequent release of the support member 62 by the thrust member 63 and the consequent retraction of the injection needle 34 inside the device 1 due to the thrust exerted on the member of support 62 by the compression spring 64.

The instruction member 61 comprises a coupling part 61c engaged with the endless screw 54. The coupling part 61c is a toothing extended circumferentially over a predetermined angle, preferably less than 180°.

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

As shown in Figures 7, 8, 22 to 24, the administration module 2 also includes a protective element 70 disposed around the injection needle 34 and configured to cover the tip of the injection needle 34 if the latter is in the injection position, or moves therein, for example due to a malfunction or failure of the injection needle movement mechanism 60, before applying the device 1 on the patient's skin, or if the injection needle 34 accidentally remains in the injection position when removing the device 1 from the patient's skin, for example due to accidental or voluntary withdrawal by the patient before the end of therapy administration ( ).

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

The protective element 70 is shown in detail on the .

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

In particular, the elastic element 72 is arranged between the intermediate cover 15 and an interior surface 70e which is inside the protective element 70 and which faces the intermediate cover 15 (Figures 22 and 23).

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

In reference to the , the administration module 2 includes a stopping mechanism 170 configured to stop the movement of the protection element 70.

In particular, the protective element 70 comprises a locking element 70b configured to lock the protective element 70 in the first operating position when the device 1 is removed from the patient's skin. The locking of the protection element 70 occurs when the locking element 70b interferes with a stopping element 74 associated with the rack 51 at a coupling part 55 of the rack 51 which is arranged upstream by relative to the coupling part 52 and downstream with respect to the coupling part 53 along the direction A, that is to say interposed between the coupling part 53 and the coupling part 52 (Figures 20 and 21 ).

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

The device 1 has an irreversible final configuration in which the protection element 70 is locked in the first operating position. In this configuration, the locking element 70b is in contact with the stopping element 74.

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

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

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

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

Moving the locking member 70b along the direction F first causes the locking member 70b to interfere with the stopping member 74, and then the locking member 70b transitions to the opposite side of the stopping element 74 due to the deformation of the latter.

In particular, the stopping element 74 comprises a first surface facing away from the plane P and a second surface facing the plane P.

The first surface allows deformation of the stop element 74 as a result of interference with the lock element 70b and movement of the lock element 70b along the direction F from the second operating position to the first operating position.

The first surface is preferably inclined relative to a plane orthogonal to the direction F, thereby facilitating the transition of the locking element 70b from one side to the other side of the stop element 74 as a result of the deformation of the latter.

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

As shown on the , the protective element 70 has a base 70a provided with a through hole 71 to allow the transition of the injection needle 34 during the movement of the injection needle 34 between the rest position and the position d injection when the protection element 70 is in the second operating position.

The base 70a comprises a raised edge 70b defining in the base 70a a recess 70c which accommodates the tip of the injection needle 34 both when the protection element 70 is in its second operating position and the needle d The injection 34 is in the rest position ( ) and when the protection element 70 is in its first operating position and the injection needle 34 is in the injection position ( ).

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

The device 1 comprises a position sensor 76 (FIGS. 7 and 8) adapted to detect contact of the device 1 with the patient's skin.

The position sensor 76 comprises a magnet 77 associated in one piece with the protection element 70 and a Hall effect sensor 78 arranged in the control module 3 near the magnet 77.

The magnet 77 is entirely housed in a seat 75 formed in the protective element 70 ( ).

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

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

The flexible sleeve 80 is made of a medical grade silicone material.

The flexible sleeve 80 surrounds the protective element 70 and includes a base surface 80a having an interior surface integrally associated with the exterior surface of the base 70a of the protection element 70.

In the embodiment illustrated here, the flexible sleeve 80 is defined by a bellows-type membrane having a frustoconical shape.

The flexible sleeve 80 is arranged entirely inside the administration module 2 when the protective element 70 is in its second operating position ( ).

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

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

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

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

The patch 90 includes an adhesive layer 91 integrally attached to the application surface 12 and a protective layer 92 removably attached to the adhesive layer 91. Before administering the therapy, the protective layer 92 is withdrawn ( ) and the device 1 is attached to the patient's skin through the adhesive layer 91.

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

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

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

As already mentioned, the protection element 70 is initially in its extended configuration of the and the cover 100 covers the protective element 70, as shown in the .

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

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

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

In particular, the control unit 7 drives the magnetic rotor 56 alternately in a first direction of rotation to activate the movement transmission member 50 and in a second direction of rotation opposite the first direction of rotation to drive the administration medicine from the container 22 during the activation of another movement transmission member 111 ( ) arranged in the main body 11 on the side opposite the movement transmission member 50 relative to the magnetic rotor 56 and the endless screw 54.

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

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

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

There shows the operating configuration in which the injection needle 34 is in the rest position and the protective element 70 and the flexible sleeve 80 protrude from the device.

Figures 26 and 33 show the operating configuration in which the device is applied to the patient's skin. The injection needle 34 is still in the rest position and the protective element 70 and the flexible sleeve 80 are pushed inside the device. Only the base 70a of the protective element 70 remains projecting from the device.

There shows the operating configuration in which the device is applied to the patient's skin and the injection needle 34 is in the injection position to deliver therapy. The protective element 70 and the flexible sleeve 80 are always inside the device.

There shows the operating configuration in which the device is still applied to the patient's skin, but the injection needle 34 has been returned to the rest position.

There shows the operating configuration in which the device is removed from the patient's skin at the end of therapy delivery. The protective element 70 and the flexible sleeve 80 protrude from the device.

Figures 32 and 34 show the operating configuration in which the device is removed from the patient's skin before therapy delivery is completed and the injection needle 34 is still in the injection position. The protective element 70 and the flexible sleeve 80 protrude from the device and the protective element 70 is locked in position outside the device.

In this embodiment, the instruction member 61 comprises two articulated arms 631 arranged on opposite sides relative to the thrust element 63c ( ). As illustrated on the , each articulated arm 631 comprises a first lever 631a articulated on the exterior lateral surface 61g of the instruction member 61 and a second lever 631b articulated on the first lever 631a. Each second lever 631b is slidably coupled to a respective guide 633 and includes a respective stop element 174 whose shape and material are similar to those of the stop element 74 described above.

The protective element 70 comprises two locking elements 171 arranged on diametrically opposite sides relative to the stop element 62c and configured to cooperate with the stop elements 174 ( ).

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

In the operating configuration of Figures 25 to 30, the two locking elements 171 are arranged on one side relative to the stopping elements 174, in particular near the shaped plate 630. This is due to the fact that the protective element 70 does not project from the device.

When the protective element 70 exits the device following removal of the device from the patient's skin, the locking elements 171 pass beyond the stop elements 174 locking the protective element 70 in the position shown on the . In this operating configuration, the injection needle 34 has previously been returned inside the device.

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

Also with reference to the , the sequence of operating steps implemented by the device 1 during its use is described in detail below.

During a first time interval preceding the instant t0 where the patient activates the device 1 by acting on the activation button 3a, the patient separately receives the administration module 2 and the control module 3 and couples them. During this time interval, the device 1 is in standby mode, that is to say the energy supply battery 8 only powers some of the electronic components present in the control module 3 thanks to the supply of 'a hardware unit which cuts off the energy supply to all electronic components except those associated with: the ignition magnet 2a, the switch which supplies energy to the control unit 7, the ignition button activation 3a to activate device 1 and NFC tag 2b. Motor 9 is not supplied with energy.

After mutual coupling, the administration module 2 and the control module 3 are temporarily coupled not only mechanically but also via a magnetic coupling established by the proximity between the magnetic drive rotor 9a provided in the module control unit 3 and the magnetic rotor 56 provided in the administration module 2. The control unit 7 is energized thanks to a change in magnetic field generated by the mutual approach between the ignition magnet 2a and the switch which supplies energy to the control unit 7 which are closer. This mutual approach triggers the switch mentioned above, which powers up the control unit 7.

Once powered on, the control unit 7 performs a self-diagnosis.

Additionally, after powering on, the control unit 7 interrogates the NFC tag 2b by reading the information stored there. In particular, the control unit 7 performs any or all of the following actions: checking whether the administration module 2 has already been used, checking whether the administration module 2 is configured to administer a correct dosage of the drug, establishing the method of administering the drug, establishing the speed of drug administration.

After powering up, the control unit 7 also reads the signal from the position sensor 76 to establish whether the device 1 is in contact with the patient's skin.

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

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

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

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

At this stage (that is to say at time t0), the device 1 is put into operation by the patient by pressing the activation button 3a. The motor 9 is activated and the control unit 7 orders a series of operations which do not require any action on the part of the patient.

In a time interval t1 following time t0 and which lasts for example 10 to 15 seconds, the magnetic rotor 56 is rotated in the first direction of rotation by the motor 9 and activates the movement transmission member 50, which in turn simultaneously activates the fluid path opening system 40 (the piercing needle 32 pierces the pierceable septum 24 and the elastic element 46 extends) and the injection needle movement mechanism 60 without however move the injection needle 24, which remains in the rest position.

In particular, the rotation of the endless screw 54 causes the movement of the rack 51 along the direction A and the consequent rotation of the drive member 48 and the opening of the fluid path 30. This rotation also causes the rotation of the instruction member 61 which moves from the angular stopping position of the to another angular stopping position, shown on the . This rotation does not cause any rotation of the thrust member 63, which remains in the first operating position due to the fact that the projecting element 63d remains abutting against the abutment surface 61e.

In a time interval t2 following the time interval t1 and which lasts for example 8 to 12 seconds, the magnetic rotor 56 is rotated in the second direction of rotation by the motor 9 and activates the movement transmission member 111, causing the movement of the piston 26 inside the container 22. Such movement causes the exit of the medicine through the piercing needle 32, but not the administration of the medicine through the injection needle 34. The thrust exerted by the piston 26 on the medication causes the air contained in the fluid path 30 to escape (priming phase).

In a time interval t3 following the time interval t2 and which lasts for example 8 to 12 seconds, the magnetic rotor 56 is rotated again in the first direction of rotation by the motor 9 and again activates the member movement transmission 50, causing the reactivation of the injection needle movement mechanism 60.

In particular, the rotation of the endless screw 54 causes an additional rotation of the instruction member 61 which moves from the angular stopping position of the at the first angular position of release of the . This rotation causes the movement of the pushing member 63 from the first service position to the second service position and, consequently, the movement of the support member 62 (and therefore of the injection needle 34) from the first operating position (injection needle 34 in the rest position) to the second operating position (injection needle 34 in the injection position). The injection needle 34 thus penetrates the patient's skin.

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

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

In particular, the rotation of the endless screw 54 causes an additional rotation of the instruction member 61 which moves from the first angular position of release of the at the second angular release position of the . This rotation causes a similar rotation of the thrust member 63 due to the fact that the projecting element 63d is housed in the seat 61a and, consequently, the decoupling between the thrust element 63c and the stop element 62c. At this point, the force exerted by the compression spring 64 on the support member 62 moves it from the second operating position to the first operating position, leaving the thrust member 63 in the second operating position. The injection needle 34 thus returns to the rest position, that is to say inside the device 1.

The control unit 7 emits an end of therapy signal n seconds after causing the instruction member 61 to move from the first angular position for releasing the at the second angular release position of the , in order to be sure that the patient can remove the device from his skin when the injection needle 34 has returned to the rest position, that is to say that it is inside the device 1 .

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

The patient can then remove the device 1 from his skin.

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

Claims (10)

Device (1) for subcutaneous administration of a medication, comprising:
- an injection needle (34) configured to inject the medication into a patient when the device (1) is applied to the patient's skin, the injection needle (34) being movable between a rest position in which the the injection needle (34) is arranged entirely inside the device (1) and an injection position in which the injection needle (34) protrudes at least partially from the device (1) through a through opening (12a) of the device (1);
- a protective element (70) arranged around the injection needle (34) and movable between a first operating position in which the protective element (70) projects from the device (1) and a second position of operation in which the protective element (70) does not protrude from the device (1);
- a flexible sleeve (80) associated in a watertight manner with the device (1) around said through opening (12a) and associated in one piece with the protective element (70). Device (1) according to claim 1, wherein the protective element (70) comprises a base (70a) provided with a through hole (71) to allow the passage of the injection needle (34) during the movement of the injection needle (34) between the rest position and the injection position and in which the flexible sleeve (80) is integrally associated with said base (70a). Device (1) according to claim 2, wherein the flexible sleeve (80) is defined by a membrane having an internal surface which is integrally associated with the external surface of said base (70a). Device (1) according to claim 3, in which said membrane is of the bellows type and has a substantially conical or frustoconical shape. Device (1) according to any one of claims 2 to 4, wherein the flexible sleeve (80) has a base surface (80a) integrally associated with the base (70a) of said protective element (70) and wherein said base surface (80a) covers said through hole (71) and can be pierced by the injection needle (34) when the injection needle (34) moves from the rest position to the position injection. Device (1) according to any one of claims 2 to 4, in which the through hole (71) of the base (70a) of the protective element (70) is closed by a pierceable septum (171) configured to be pierced by the injection needle (34) when the injection needle (34) moves from the rest position to the injection position. Device (1) according to any one of the preceding claims, wherein said flexible sleeve (80) is entirely arranged inside said device (1) when said protective element (70) is in its second operating position. Device (1) according to any one of the preceding claims, comprising a compression ring (83a) welded to an application surface (12) of the device (1) at said through opening (12a) and in which said sleeve flexible (80) comprises an annular end portion (83) which is interposed between said application surface (12) and said compression ring (83a). Device (1) according to claim 8, wherein said compression ring (83a) is welded by ultrasonic welding. Device (1) according to any one of the preceding claims, wherein said flexible sleeve (80) is made of a silicone material for medical use.