System for controlling a product administration device, and associated product administration device

Abstract

This system (4) for controlling a product administration device comprises a motorization assembly (12), a piston (14), a control member (16), and an activation element (20) for activating a device for inserting a needle into a site. The control member comprises a threaded rod intended to be driven in rotation by the motorization assembly (12), and an operating element (162) intended to be driven in translation along the threaded rod when the threaded rod is driven in rotation, so as to bring about the displacement of the piston (14). The activation element (20) is movable between a rest position and a position of activation of the needle insertion device. The operating element (162) is likewise able to operate the displacement of the activation element (20) between its rest position and its activation position, during its movement in translation along the threaded rod. The activation element (20, 620) is movable in translation between its rest position and its activation position.

Description

[0001] TITLE: Control system for a product delivery device and associated product delivery device

[0002] The present invention relates to a control system for a product delivery device, in particular a drug intended to be administered parenterally. The invention also relates to a product delivery device comprising the control system.

[0003] In the field of administering products and in particular drugs by parenteral route, it is known to use portable injection devices intended to be fixed on the body of a patient, in particular by means of an adhesive patch, to carry out an infusion of drug, i.e. intradermal, intramuscular, subcutaneous, etc. Such devices offer the advantage for a patient of being able to receive the administration of the drug by parenteral route at home, over a relatively long period, up to several hours, without being immobilized. In addition, these devices advantageously allow the administration of drug without the assistance of a nursing staff.

[0004] Advantageously, some of these injection devices comprise a disposable part, provided with a product container and a needle insertion device, and a reusable part, suitable for being attached to the disposable part and comprising for example a reusable control system making it possible to control the expulsion of the product from the container.

[0005] In particular, WO2017 / 219156 A1 discloses a control system for a product administration device and an associated product administration device. The product administration device is intended to be attached to a patient's body, in particular by means of an adhesive patch, and comprises the control system, a drug container, and a device for inserting a needle into a site. In WO2017 / 219156 A1, the control system of the administration device makes it possible to control both the expulsion of the product from a product container and the activation of a device for inserting a needle into a site. However, the control system is mechanically complex, which in particular results in high cost and a high risk of failure.

[0006] On the other hand, it is known from U S2020 / 0114068 to mount a nut on a threaded rod of a control system of a product delivery device and to rotate a lever that activates a needle insertion device. The rotation of the lever takes up space, which makes this control system bulky and impractical to integrate into a product delivery device such as a portable drug delivery device.

[0007] Other known systems from WO2016 / 145094, WO2022 / 104362, EP3260146, EP3501576 and WO2018 / 204779 induce disadvantages comparable to those mentioned above.

[0008] The invention therefore aims to propose a control system for a product administration device whose structure is simplified and whose reliability is improved.

[0009] To this end, the invention relates to a control system for a product administration device, the control system comprising a motorization assembly, a piston, a control member and an activation element for a device for inserting a needle into a site. The control member comprises a threaded rod intended to be driven in rotation by the motorization assembly, and a control element driven in translation along the threaded rod when the threaded rod is driven in rotation, to cause the piston to move. The activation element is movable between a rest position and an activation position of the needle insertion device. The control element also controls the movement of the activation element between its rest position and its activation position, when it is driven in translation along the threaded rod.According to the invention, the activation element is movable in translation between its rest position and its activation position.

[0010] By means of the invention, the movement of the control element along the threaded rod allows both the expulsion of the product from the product container and the activation of the needle insertion device. The structure of the control system is thus simplified and the reliability of the system is improved since the movement of the control element, which is essential for the administration of the product, is used to also activate the needle insertion device.

[0011] According to various aspects of the invention, the control system comprises one or more of the following features, taken individually or in any technically permissible combination:

[0012] - the control element controls the translational movement of the activation element from its rest position to its activation position and the translational movement of the activation element from its activation position to its rest position;

[0013] - the piston comprises a flexible rod and a thrust element capable of acting on a piston stopper of a product container to expel the product from the container, the flexible rod comprising a pilot end intended to be in contact with the pilot element and a thrust end intended to be in contact with the thrust element;

[0014] - the flexible rod is formed by a spring and the activation element is fixed to the threaded rod, the spring being able to exert a thrust force on the threaded rod via the control element, so as to move the activation element from its rest position to its activation position when the thrust element is resting on the piston stopper and when the control element is driven in translation along the threaded rod in a direction of deployment of the piston;

[0015] - the pilot end is fixed to the pilot element and the thrust end is fixed to the thrust element, and the spring is capable of exerting a tensile force on the threaded rod via the pilot element, so as to move the activation element from its activation position to its rest position when the pilot element is driven in translation along the threaded rod in a direction of retraction of the piston;

[0016] - the control element is capable of moving the piston to control the expulsion of the product from the container, when the control element is driven in translation along the threaded rod in a direction of deployment of the piston, as well as moving the activation element from its rest position to its activation position, when the control element is driven in translation along the threaded rod in a direction of retraction of the piston;

[0017] - the system comprises a return element capable of exerting a return force on the activation element towards its rest position;

[0018] - the activation element comprises a rod around which the return element extends and a shoulder in contact with the return element;

[0019] - the activation element is received in a zone comprising a first end and a second end opposite along an axis of movement of the activation element, the first end defining a stop in contact with the activation element when it is in its rest position;

[0020] - the second end defines either a second stop in contact with the activation element, when it is in its activation position, or a support surface for a return element;

[0021] - the system comprises a first housing for receiving the motorization assembly, the control member and the activation element and the first housing comprises a first orifice for the passage of the activation element capable of being crossed by the activation element when it is in its activation position, the activation element then projecting relative to the first housing; - the system comprises a first housing for receiving the motorization assembly, the control member and the activation element and the first housing is capable of being assembled in a removable manner with a second housing receiving the needle insertion device and advantageously a product container;

[0022] - the system comprises a first housing capable of receiving the flexible rod, the threaded rod and the control element, the first housing comprising a wall provided with a longitudinal slot and the control element comprises a radial projection intended to be received in the longitudinal slot, so as to block the rotation of the control element relative to the first housing; and

[0023] - the activation element comprises a contact end and an activation end, the contact end defining a housing for receiving the radial projection, when the control element drives the activation element from its rest position to its activation position via the radial projection.

[0024] The invention also relates to a product administration device comprising a first part provided with a control system as mentioned above and a second part receiving the needle insertion device and a product container.

[0025] Advantageously, the control system comprises a first housing for receiving the motorization assembly, the control member and the activation element and the first housing comprises a first orifice for passage of the activation element capable of being crossed by the activation element when it is in its activation position, the activation element then projecting relative to the first housing, while the second part comprises a second housing for receiving the needle insertion device, the second housing being intended to be removably assembled to the first housing, and the second housing comprises a wall provided with a second orifice capable of being positioned opposite the first orifice when the first and second housings are assembled, the activation element being capable, when it is in its activation position,to pass through the second port to activate the needle insertion device and trigger insertion of the needle into a site.,

[0026] The invention will be better understood and other advantages thereof will appear in the light of the description which follows, given solely by way of non-limiting example, and made with reference to the appended drawings, in which:

[0027] [Fig.1] Figure 1 is a perspective view of a product delivery device according to a first embodiment of the invention, comprising a reusable control system according to the first embodiment of the invention, the delivery device being ready for use; [Fig.2] Figure 2 is a perspective view of the assembly of a disposable part on the reusable control system of the device of Figure 1;

[0028] [Fig. 3] Figure 3 is a perspective view of the reusable control system of Figures 1 and 2, with one half-shell of a housing omitted;

[0029] [Fig.4] Figure 4 is an exploded view of the reusable control system of Figure 3;

[0030] [Fig.5] Figure 5 is an enlarged exploded view of detail V of Figure 4;

[0031] [Fig.6] Figure 6 is a partial top view of the product delivery device of Figures 1-2 including the reusable control system of Figures 3 and 4, a half-shell of a housing being omitted, and a product container associated with said control system, the control system being in a rest configuration;

[0032] [Fig.7] Figure 7 is a view similar to Figure 6, the control system being in a configuration for activating a device for inserting a needle into a site;

[0033] [Fig.8] Figure 8 is a view similar to Figures 6 and 7, the control system being in a configuration of contacting a thrust element and a piston stopper;

[0034] [Fig.9] Figure 9 is a view similar to Figures 6 to 8, the control system being in a configuration of completion of the expulsion of the product from the container 5

[0035] [Fig.10] Figure 10 is a partial top view of a product delivery device according to a second embodiment comprising a reusable control system according to the second embodiment of the invention, a half-shell of a housing being omitted, and a product container associated with said control system, the control system being in a rest configuration;

[0036] [Fig.11] Figure 11 is a view similar to Figure 10, the control system being in a configuration of contacting a thrust element and a piston stopper;

[0037] [Fig.12] Figure 12 is a view similar to Figures 10 and 11, the control system being in a configuration for activating a device for inserting a needle into a site; [Fig.13] Figure 13 is a view similar to Figures 10 to 12, the control system being in a configuration for completing the expulsion of the product from the container;

[0038] The product delivery device 2 shown in full in Figures 1 and 2 is in accordance with a first embodiment of the invention and comprises a reusable control system 4 in accordance with the first embodiment of the invention, as well as a disposable part 6.

[0039] This disposable part 6 comprises a housing 8 formed from two half-shells 82 and 84 and which contains a cartridge 10 of product to be administered, this cartridge being partially visible through a window 86 cut out in the half-shell 82 of the housing 8.

[0040] The cartridge 10, also called a product container, comprises a body 102, made of glass or plastic material, as well as a sliding stopper 104, also called a piston stopper, preferably made of elastomer and which is designed to slide along a longitudinal axis X10 of the cartridge 10 inside the cartridge.

[0041] In the figures, the cartridge 10 is shown transparent.

[0042] The cartridge 10 is intended to be connected, opposite the sliding cap 104, to a subassembly for administering the product, not shown, which comprises in particular a device for inserting a needle into a site and a fluid path extending between the cartridge and the needle insertion device. The needle insertion device is, for example, provided with a needle and a cannula and comprises an assembly for controlling the position of the needle and the cannula. The control assembly is, for example, capable of moving the needle and the cannula from a retracted position in which they are included inside the housing 8 to a deployed position in which the needle and the cannula extend outside the housing 8 and are capable of being positioned through the skin of a user.The control assembly is also capable, after insertion of the needle through the user's skin, of moving the needle from the deployed position to the retracted position in order to maintain only the cannula in the user's skin, the product being delivered to the user via said cannula. The needle insertion device is for example in accordance with the technical teaching of one of the documents WO-A-2021 / 224388 and WO-A-2022 / 023391. Advantageously, the needle insertion device comprises a member for releasing the needle and the cannula, the release member being capable, when moved via an activation element, of allowing the needle and the cannula to move from the retracted position to the deployed position.

[0043] Advantageously, the disposable part 6 also comprises the administration subassembly received in the housing 8. The part 6 is intended to be mounted on the control system 4 by sliding in the direction of the arrow F1 in FIG. 2, to be controlled by the control system 4 during the administration to a user of the product contained in the cartridge 10, then to be discarded when the cartridge 10 has been emptied or when the quantity of product to be administered present in this cartridge reaches a predefined minimum value. Thus, several disposable parts 6 can be successively mounted on the control system 4 which is reused with each of these different parts 6.

[0044] The control system 4 comprises a motor assembly 12, a piston 14, a control member 16, an activation element 20 of the needle insertion device and advantageously a control interface 22.

[0045] The control system 4 advantageously comprises a housing 24 formed of two half-shells 242 and 244. As shown in FIGS. 1 to 3, the piston 14, the control member 16 and the activation element 20 are housed in the housing 24 and the control interface 22 is positioned on an outer face of the housing 24, for example on the half-shell 242.

[0046] The control system 4 also includes a battery 25, shown in FIG. 4 and held in place in the half-shell 244 by a cover 26 attached and immobilized on this half-shell.

[0047] The motor assembly 12 comprises an electric motor 42 and at least one gear 46, driven by the motor 42.

[0048] The motor 42 is capable of selectively driving the gear 46 in rotation in a first direction and a second direction, opposite to the first direction.

[0049] The piston 14 is configured to push the sliding plug 104 towards a product expulsion end of the cartridge 10, along the axis X10, in order to control the expulsion of the product. This piston 14 is visible via a lateral opening formed on a lateral face 226 of the housing 24. The movement of the piston to push the sliding plug 104 causes the expulsion of the product contained in the cartridge 10 from the cartridge 10.

[0050] The piston 14 comprises a piston rod 141 and a thrust member 143 attached to the piston rod.

[0051] The thrust element 143 is adapted to be positioned opposite the sliding plug 104 when the housing 8 and the housing 24 are assembled to each other. The thrust element 143 is visible via the lateral opening formed on the lateral face 226 when the housing 24 is disassembled from the housing 8.

[0052] A front face 143A of the thrust element 143 is defined as a face facing the plug 104 when the parts 4 and 6 are assembled to form the device 2. A rear face 143B of the thrust element 143 is defined as a face facing away from the front face.

[0053] The piston rod 141 comprises a pilot end 141A intended to be in contact with the control member 16 and a thrust end 141B intended to be in contact with the thrust element 143.

[0054] In Figures 6 and following, the piston rod 141 is shown in axis lines between its ends 141 A and 141 B.

[0055] The piston rod 141 is, for example, a flexible rod formed by a spiral spring and the thrust element 143 is capable of being fixed to the spring, for example by screwing onto the thrust end 141B. The turns of the spring form, for example, at the end 141B a thread suitable for cooperating with a corresponding thread formed on a stud provided on the rear face 143B of the thrust element 143, at an attachment zone 145 of the thrust element 143.

[0056] The thrust element 143 is capable of acting on the piston stopper to expel the product from the container 10. The thrust element 143 is capable of passing through the lateral opening to come into contact with the piston stopper 104 when expelling the product from the container.

[0057] The front face 143A of the pushing element 143 is equipped with a protuberance, in other words a nose, 146 intended to penetrate into a housing 106 of corresponding shape provided on a rear side 104B of the stopper 104 facing the piston 14 in the configuration for use of the product administration device 2.

[0058] The thrust element 143 is movable between a rest position and several operating positions. In the rest position, shown in particular in FIG. 6, the thrust element 143 bears against the housing 24 and advantageously disengaged from the body 102 of the cartridge 10. In one of the operating positions, as shown in FIG. 8, the thrust element 143 pushes the stopper 104 towards the product expulsion end of the cartridge 10 and is advantageously engaged in the body 102. Several operating positions of the piston 14 are distributed along an axis X14 of movement of the thrust element coinciding with the axis X10 in the assembled configuration of the product administration device 2.

[0059] The control member 16 comprises a threaded rod 161 intended to be driven in rotation by the motorization assembly 12 and a control element 162 intended to be driven in translation along the threaded rod 161 when the threaded rod 161 is driven in rotation, to cause the displacement of the piston 14. The movements of the control element 162 are parallel to the longitudinal axis X161 of the threaded rod 161. The threaded rod 161 is for example associated with the gear 46 which is driven in rotation by the electric motor 42. The gear 46 comprises for example a first toothed wheel 46A and a second toothed wheel 46B meshed, with the second toothed wheel 46B fixed to the threaded rod 161 and able to be driven in rotation by the electric motor 42 via the first toothed wheel 46A.

[0060] The control element 162 is fixed to the control end 141A of the piston rod, opposite the thrust end and is capable of controlling the movement of the piston rod 141 and therefore of the thrust element 143 during its movement. The control element 162 is for example capable of being fixed to the spring forming the piston rod 141 by screwing at the control end 141A. The control element 162 is, for example, formed by a nut, visible in FIG. 5, comprising a radial projection 164 and an external thread 169 capable of cooperating with the turns of the spring at the control end 141A which form a complementary thread for fixing the control element

[0061] 162 to the piston rod 141. The pilot element 162 is provided with an internal thread

[0062] 163 intended to cooperate with the thread of the threaded rod 161.

[0063] In Figure 5, the parts 162 and 164 of the motor assembly 12 are shown twice, in order to show their positioning on the one hand with respect to the threaded rod 161 and on the other hand with respect to the piston 14.

[0064] The radial projection 164 is adapted to interact with the activation element 20 to control the movement of the activation element.

[0065] Advantageously, the control member 16 also comprises a chute 165 configured generally in the shape of a J, and capable of receiving the piston rod 141. Thus, the chute gives the piston rod a curved shape when it is positioned therein so that the piston rod comprises a first rectilinear part at the level of its pilot end 141A, a second rectilinear part at the level of its thrust end 141B and a curved part connecting the first rectilinear part and the second rectilinear part.

[0066] Preferably, the chute forms a first housing 166 capable of receiving the piston rod 141, the threaded rod 161 and the control element 162. The first housing 166 comprises a wall 167 provided with a longitudinal slot 168 in which the radial projection 164 of the control element 162 is received so as to block the rotation of the control element relative to the first housing and thus to prevent the rotation of the control element during the rotation of the threaded rod 161. The chute 165 is, for example, formed by two half-shells, namely a lower half-shell and an upper half-shell assembled to each other. The threaded rod 161 and the control element 162 form a mechanism for transforming the rotary output movement of the gear 46 into a translational movement intended to be transmitted to the piston 14 and in particular to the thrust element 143 along the axis X14 in the assembled configuration of the product administration device 2.

[0067] Here, the connection between elements 161 and 162 is of the screw-nut type.

[0068] The control element 162 moved by the threaded rod 161 is thus able to control the movement of the piston 14, by acting on the control end 141A of the piston rod 141, in particular to control the movement of the piston stopper 104 within the cartridge 10 and therefore the expulsion of the product from the cartridge 10.

[0069] The control element 162 is also capable, during its translational drive along the threaded rod 161, of controlling the translational movement of the activation element 20 between a rest position visible in FIG. 6 and an activation position of the needle insertion device, which position is visible in FIG. 7.

[0070] More precisely, in the first embodiment shown in figures 1 to 9, when the motor 42 drives the gear 46 in rotation in the first direction, the control element 162 is driven in translation along the threaded rod in a direction of deployment of the piston 14 to control the expulsion of the product from the container. In other words, the pilot element 162 is driven in translation in order to move the thrust element 143 of the piston 14 towards the expulsion end of the cartridge 10, to expel product from the cartridge 10. Thus, due to the curved shape of the piston rod 141, when the pilot element 162 is moved in the direction of deployment of the piston, the thrust element 143 is moved in a direction corresponding to the arrow F2 noted in FIG. 6, while the pilot element 162 is moved in an opposite direction corresponding to the direction of the arrow F1 noted in FIG. 2 and reproduced in FIG. 6.

[0071] Furthermore, when the motor 42 rotates the gear 46 in the second direction, the control element 162 is driven in translation along the threaded rod in a retraction direction of the piston 14, in the direction of the arrow FT noted in FIG. 6, to control the retraction of the piston and the movement of the activation element 20 between the rest position and the activation position of the needle insertion device, when the control element 162, and in particular the radial projection 164, are in contact with the activation element 20. In other words, the control element 162 is driven in translation in order to move the piston 14 towards the housing 24 opposite the product expulsion end of the cartridge 10, in the direction of the arrow F2' noted in FIG. 6.Thus, due to the curved shape of the piston rod 141, when the pilot element is moved in the retraction direction of the piston 14, the thrust element 143 is moved in a direction corresponding to the arrow F2' while the pilot element 162 is moved in an opposite direction, corresponding to the direction of the arrow F2 noted in FIG. 6.

[0072] Advantageously, the activation element 20 is capable, during its translational movement from its rest position to its activation position, of coming into contact with the release member and actuating it to allow the needle and the cannula to move from their retracted position to their deployed position.

[0073] The activation element 20 comprises, for example, a rod 201 for selectively activating the needle insertion device.

[0074] More specifically, in the first embodiment, the activation element 20 comprises the rod 201 around which extends a return element 202 and a shoulder 203, extending radially to the rod 201 and in contact with the return element 202. The return element 202 is capable of exerting on the activation element 20 a return force towards its rest position.

[0075] In more detail, the activation element 20 is received in a receiving zone Z of the housing 24 comprising a first end 204 and a second end 205 opposite along a displacement axis X20 of the activation element 20. The first end 204 defines a stop in contact with the activation element 20 when it is in its rest position and the second end 205 defines a bearing surface for the return element 202. The return element thus extends between the second end 205 and the shoulder 203. The receiving zone Z is, for example, formed on an upper face of the chute 165 as visible in FIG. 5.

[0076] Advantageously, the return element 202 is a compression spring.

[0077] In the rest position of the activation element 20, the rod 201 is held inside the housing 24 and in its activation position the rod 201 extends projecting from the housing 24, in particular from a lateral face 226' parallel to the lateral face 226, advantageously through a first orifice 208 for the passage of the activation element formed through a wall of the housing 24.

[0078] Advantageously, the housing 8 comprises a wall provided with a second orifice, not shown, capable of being positioned opposite the first orifice 208 when the housing 24 and the housing 8 are assembled. The activation element 20 is capable, when it is in its activation position, of passing through the first orifice 208 and the second orifice to activate the needle insertion device and trigger the insertion of the needle into a site.

[0079] Advantageously, the activation element 20 comprises an activation end 209 formed for example by a free end of the rod 201 opposite the shoulder 203 and a contact end 210 extending opposite the rod towards the inside of the housing 24. The contact end 210 defines a housing 211 for receiving the radial projection 164, when the piloting element 162 drives the activation element 20 from its rest position to its activation position by means of the radial projection 164. The contact end 210 comprises, for example, two arms 212 extending from the shoulder 203 towards the inside of the housing 24 and defining a slot for receiving the radial projection 164. The piloting of the activation element 20 by the piloting element 162 is a mechanical control which results from the radial projection 164 being pressed into the housing 211 of the contact end 210.

[0080] Advantageously, the translational movements of the activation element 20 take place in two opposite directions, between its rest and activation positions. The transition from the rest position of Figure 6 to the activation position of Figure 7 takes place when the radial projection 164 engaged in the housing 211 of the contact end 210 pushes the rod 201 of the activation element 20 against the force exerted by the spring 202. The transition from the activation position of Figure 7 to the rest position of Figure 6 takes place when the radial projection 164 engaged in the housing 211 of the contact end 210 brakes and controls the movement of the rod 201 under the action of the force exerted by the spring 202. Thus, the control element 162 controls the translational movement of the activation element 20 from its rest position to its activation position and vice versa.

[0081] The control interface 22 comprises several control buttons 130 as well as display members 132 constituted by light-emitting diodes or LEDs, each display member being associated with a mark 134 in the form of a logo representing a quantity displayed by this member. The control interface makes it possible in particular to control the motorization assembly 12 via an electronic control card 44.

[0082] The control card 44 is configured to activate the motor 42 according to the orders received through the interface 22 and to return the thrust element 143 of the piston 14 to its rest position when the product contained in the cartridge 10 has been completely used, or used in a predetermined quantity.

[0083] The constituent elements of the reusable control assembly 4 are relatively elaborate and expensive, hence the advantage of using them successively with several disposable parts 6.

[0084] Screws 50, visible in figures 3 and 4, are used to immobilize the half-shells 242 and 244 together. In the first embodiment shown, the screws 50 pass through corresponding housings provided on the half-shell 244 and are screwed into corresponding threads of the half-shell 242. Other means of assembling the half-shells together are conceivable, in particular means of assembly by elastic snap-fastening.

[0085] As is more particularly apparent from Figure 2, the housing 8 of the disposable part 6 is equipped with a hook 88 which constitutes a member for securing the parts 4 and 6 in the assembled configuration of the product administration device 2. The hook 88 is in one piece with the half-shell 84 and comprises a head 882 and a rod 884 which connects the head 882 to the rest of the half-shell 84.

[0086] On the other hand, as shown in Figure 3, the half-shell 244 comprises a rigid portion 136 which defines a sliding ramp 138 of the head 882 during a movement of bringing the parts 4 and 6 together, in the direction of the arrow F1 in Figure 2. The rigid portion 136 also defines a hooking surface 140, perpendicular to the axis X14, against which the head 882 comes into abutment in the assembled configuration of the parts 4 and 6 of the product administration device 2.

[0087] A push button 52 is mounted on the housing 24 and comprises a head 522 of preferably domed external shape and received in a housing of corresponding shape, this housing being defined by the two half-shells 242 and 244. Without action by a user on the push button 52, the external surface 522S of the head 522, that is to say the surface of this head which is visible from the outside of the housing 24, is flush with an external surface of the housing 24.

[0088] We note A52 a longitudinal axis A52 of the push button 52

[0089] The push button 52 also comprises a rod 524 which extends along the longitudinal axis A52.

[0090] In the mounted configuration of the reusable control assembly 4, the axis A52 is superimposed on an axis X24 defined by the housing 24 and which is a sliding axis of the push button 52 in the housing 24.

[0091] By default, the push button 52 is pushed back by two springs 54 into the position of figures 1 to 3 where its rod 524 does not interact with the hook 88 and where the surface 522S is flush with an outer face of the housing 24.

[0092] The external surface 522S of the head 522 bears a mark 532 which represents a padlock, in order to remind that the push button 52 makes it possible to unlock the disposable part 6 with respect to the reusable control system 4. Indeed, when the head 522 is pushed into the housing by exerting on its surface 522S a force E1 directed towards the inside of the housing 24, the push button 52 exerts, by means of an end 525 of the rod 524, an oriented force, and of sufficient intensity, to push back the head 882 of the hook 88, so as to release it from the hooking surface 140. The movement of the head 882 of the hook 88 under the action of the push button 52 takes place by means of an elastic deformation in flexion of the rod 884 of the hook 82.

[0093] Thus, the push button 52 is movable in translation along the axes A52 and X24 combined, between a first position of attachment and a second position of disengagement. In its first position and when the parts 4 and 6 are assembled, the push button 52 is not in contact with the hook 88, so that it is disengaged from this hook. In other words, in this position, the push button does not interact with the hook 88. Furthermore, in its first position, the push button defines with the hooking surface 140 a zone for receiving the hook 88. In its second position, the push button is located in the zone for receiving the hook.Thus, when parts 4 and 6 are assembled and the push button is moved to its second position, the end 525 of the rod 524 of the push button pushes the head 882 of the hook 88, against an elastic force exerted by the rod 884, to separate the disposable part 6 from the reusable control system 4.

[0094] In other words, the push button 52 allows separation of the parts 4 and 6 of the product administration device 2, from the assembled configuration shown in Figure 1. The joining of the parts 4 and 6 of the product administration device 2, obtained by the hook 88, is thus reversible.

[0095] The operation of the administration device and in particular of the control system according to the first embodiment is described below using figures 6 to 9 which represent the control system in different configurations corresponding to different stages of operation of the control system 4 allowing the administration of product to a user.

[0096] In an initial stage of operation, after the control system 4 has been assembled to the disposable part 6 as shown in Figure 2, the control system 4 is in a rest configuration shown in Figure 6. In the rest configuration, the thrust element 143 is positioned opposite the piston stopper 104 at a distance therefrom. Furthermore, the activation element 20 is in its rest position, positioned inside the housing 24, and the pilot element 162 is positioned via the radial projection 164 in the housing 211 for receiving the radial projection.

[0097] The user then positions the administration device on his skin, on the site where the injection is to take place and fixes it by means, for example, of an adhesive patch system fixed on a face of the housing 8 intended to be in contact with the user's skin.

[0098] During a subsequent activation step, the user controls, for example by actuating one of the buttons 130 of the control interface 22, the administration of the product. During this step, following the transmission of the order to activate the administration of one of the buttons to the control card 44, the control card 44 controls the motor 42 to move the activation element 20 from its rest position to its activation position. At the end of this activation step, the control system is in its activation configuration shown in FIG. 7.For this purpose, the control card 44 controls the rotation of the gear 46 in the second direction to rotate the threaded rod 161 and cause the translation of the control element 162 towards the first orifice 208, in the direction of the arrow FT noted in FIG. 6, so that the radial projection 164 moves the activation element 20 and in particular the rod 201 towards the needle insertion device so that its end 209 comes into contact with the release member and allows the needle and the cannula to pass towards the deployed position, that is to say through the user's skin. The control element 162 exerts on the activation element 20 a force greater than that exerted by the return element 202, so that the activation element is moved from its rest position to its activation position.In the activation configuration, the rod 201 projects from the housing 24, in particular from the lateral face 226', in particular through the first orifice 208 and the second orifice.

[0099] Then, during a step of bringing the piston 14, and in particular the thrust element 143, into contact with the piston stopper 104, the control card 44 controls the rotation of the gear 46 in the first direction to drive the threaded rod 161 in rotation and cause the translation of the pilot element 162 in a direction opposite to the first orifice 208, so that the pilot element 162 moves in the direction of deployment of the piston 14. During this step, the pilot element 162 exerts a thrust force on the piston rod 141 which transmits this force to the thrust element 143, which moves towards the piston stopper 104 and comes into contact with the piston stopper 104.

[0100] When the control element 162 is moved towards the configuration for bringing the piston 14, and in particular the thrust element 143, into contact with the piston stopper 104, the control element 162 tends to move away from the activation element 20. The return element 202 exerts a force on the rod 201 so as to move it towards the rest position and to bring the activation element back into contact with the radial projection 164. During this step, when the activation element has returned to its rest position, the control element 162 continues its movement in the direction of deployment of the piston 14, in the direction of the arrow F1 noted in FIG. 6, and the radial projection 164 leaves the housing 211 as shown in FIG. 8.

[0101] Figure 8 represents the control system in its contact configuration, obtained at the end of the contacting step, in which the thrust element 143 has been moved via the piloting element 162 to come into contact with the piston stopper 104. Subsequently, once the control system 4 is in its contact configuration, an expulsion step is carried out. During this step, the control card 44 controls the rotation of the gear 46 in the first direction to rotate the threaded rod 161 and cause the translation of the pilot element 162 in a direction opposite to the first orifice 208, in the direction of the arrow F1 noted in FIG. 6, so that the pilot element 162 moves in the direction of deployment of the piston 14 to control the movement of the piston stopper 104, in the direction of the arrow F2 noted in FIG. 6, to the end for expelling product from the cartridge 10.Thus the product moves from the cartridge to the cannula and therefore to the product administration site thanks to the movement of the pushing element 143 and the piston stopper 104 through the cartridge 10.

[0102] Advantageously, the movement control of the control element 162 is different between the contacting step and the expulsion step. The movement of the control element is, for example, continuous during the contacting step and discontinuous during the expulsion step.

[0103] At the end of the expulsion step, the administration device is in the configuration shown in Figure 9, the thrust element 143 and the piston stopper 104 being close to the product expulsion end of the cartridge 10.

[0104] Then, the electronic card 44 performs a retraction step where it controls the rotation of the gear 46 in the second direction to drive the threaded rod 161 in rotation and cause the translation of the pilot element 162 in the direction of the first orifice 208, in the direction of the arrow FT noted in FIG. 6, so that the pilot element 162 drives the piston rod 141 and the thrust element 143 towards their retracted position, in the direction of the arrow F2' noted in FIG. 6.

[0105] At the end of the retraction step, the control system is in the rest configuration shown in Figure 6, while the piston stopper 104 remains at the product administration end of the cartridge 10.

[0106] Then parts 4 and 6 can be separated, by pressing the push button 52, and part 6 discarded. For a future use of the control system 4, a new disposable part 6 can be associated with it.

[0107] Advantageously, between the contacting and expulsion steps, the control system 4 is capable of carrying out a step of opening a closing membrane of the cartridge 10 intended to close the expulsion end of the product from the cartridge 10. For this purpose, during this step, the control card 44 controls the rotation of the gear 46 in the first direction to cause the translation of the control element 162 in the direction of deployment of the piston 14, in the direction of the arrow F1 noted in FIG. 6, to exert a force on the piston stopper 104, so as to increase the pressure inside the cartridge until the membrane deforms and opens. The membrane is for example opened using an opening needle positioned opposite the membrane and capable of piercing the membrane when the latter is deformed under the effect of the pressure which increases in the cartridge 10.

[0108] Thus, the administration device 2 according to the invention, and in particular the control system 4, make it possible to reliably and simply control the administration of product and the insertion into a site of a product administration member, such as a needle or a cannula. Furthermore, such a control system makes it possible to group together the constituent elements of the control assembly which are relatively elaborate and expensive in a reusable assembly 4 which can be used successively with several disposable parts 6.

[0109] A second embodiment of a control system 400 of a product delivery device 200 is shown in Figures 10-13.

[0110] In the remainder of the description of the second embodiment, elements similar to the first embodiment have the same reference numbers and only elements different from them are described and have different reference numbers.

[0111] More specifically, in this second embodiment, the disposable part 6 is similar to that of the first embodiment and the control system 400 comprises a motorization assembly 612 and an activation element 620 which differ from the first embodiment, as well as a piston 14, a control member 16 and a control interface 22 similar to those of the first embodiment.

[0112] The motor assembly 612 comprises an electric motor 642 and at least one toothed wheel 646 driven by the motor 642.

[0113] The motor 642 is capable of selectively driving the toothed wheel 646 in rotation in a first direction and a second direction, opposite to the first direction.

[0114] The activation element 620 comprises a rod 701 and a toothed wheel 702 meshed with the toothed wheel 646. The rod 701 comprises for example a free activation end 709 and a contact end 710 at the level of which the toothed wheel 702 extends, radially with rod 701.

[0115] The activation element 620 is fixed to the threaded rod 161. The rod 701 is for example integral with the threaded rod 161, so that when the toothed wheel 646 is rotated by the motor 642, the toothed wheel 702 is also rotated, as is the threaded rod 161.

[0116] The activation element 620 is received in a reception zone Z' comprising a first end 804 and a second end 805 opposite each other along a displacement axis X620 of the activation element 620. The first end 804 defines a stop in contact with the activation element 620 and in particular the toothed wheel 702, when the activation element 620 is in its rest position. The second end 805 defines a stop in contact with the activation element 620 and in particular the toothed wheel 702, when the activation element 620 is in its activation position.

[0117] In this second embodiment, the spring which forms the flexible rod 141 is capable of exerting a thrust force on the threaded rod 161 via the control element 162, so as to move the activation element 620 in translation from its rest position to its activation position when the thrust element 143 is resting on the piston stopper 104, as shown in FIG. 11, and the control element 162 is driven in translation along the threaded rod in the direction of deployment of the piston 14.

[0118] In addition, the spring which forms the flexible rod 141 is also capable of exerting a tensile force on the threaded rod 161 via the control element 162, so as to move the activation element 620 from its activation position to its rest position, when the control element 162 is driven in translation along the threaded rod 161 in the direction of retraction of the piston 14.

[0119] Thus, the control element 162 controls the translational movement of the activation element 620 from its rest position to its activation position and vice versa.

[0120] The operation of the administration device 200 and in particular of the control system 400 according to the second embodiment is described below using figures 10 to 13 which represent the control system 400 in different configurations corresponding to different stages of operation of the control system 400 allowing the administration of product to a user. If a reference is mentioned in the remainder of this description without being shown in one of figures 10 to 13, it designates the same element as that bearing the same reference in the first embodiment. Conversely, if a reference is shown in one of these figures without being mentioned in the description, it designates an element similar to that bearing this reference in the first embodiment.

[0121] In an initial stage of operation, the control system is assembled to the disposable part 6 and is in a rest configuration shown in Figure 10. In the rest configuration, the pushing element 143 is positioned opposite the plunger stopper 104 at a distance therefrom, preferably surrounded by a wall of the housing 24 defining an opening for receiving the cartridge when the housings 24 and 8 are assembled. In addition, the activation element 620 is in its rest position, inside the housing 24. Then, the user positions the administration device 200 on his skin at the site where the injection is to take place and fixes it by means, for example, of an adhesive patch system fixed on a face of the housing 8 intended to be in contact with the user's skin.

[0122] Then, the user controls, for example by actuating one of the buttons 130 of the control interface 22, the administration of product. Thus, a next step of bringing the piston into contact with the piston stopper is carried out. During this step, the control card 44 controls the rotation of the toothed wheel 646 in the direction corresponding to the direction of deployment of the piston 14. The rotation of the threaded rod 161 then causes the translation of the pilot element 162 in a direction opposite to the first orifice 208 and the pilot element 162 moves in the direction of deployment of the piston 14, in the direction of the arrow F1 noted in FIG. 10. During this step, the pilot element 162 exerts a thrust force on the piston rod 141 which transmits this force to the thrust element 143 which moves towards the piston stopper 104 and comes into contact with the piston stopper 104, in the direction of the arrow F2 noted in FIG. 10.

[0123] Figure 11 shows the control system 400 in its contact configuration, obtained at the end of the contacting step, in which the thrust element 143 has been moved via the pilot element 162 to come into contact with the piston stopper 104.

[0124] Subsequently, once the control system 400 is in its contact configuration, a needle insertion step is performed.

[0125] During the needle insertion step, the rotation of the toothed wheel 646 in the direction corresponding to the direction of deployment of the piston 14 continues and the pilot element 162 then translates in the direction of deployment of the piston 14. The pilot element 162 then exerts a thrust force on the spring forming the piston rod 141 which compresses as long as the force exerted by the piston 14 on the piston stopper 104 is less than the force of detachment of the piston stopper 104 from its initial position, relative to the cartridge 10. Thus, under the effect of the compression exerted by the pilot element 162, the spring forming the piston rod 141 exerts a thrust force on the threaded rod 161 via the pilot element 162, so as to move the threaded rod 161 and therefore the activation element 620 from its rest position to its position activation.The control system is then in its needle insertion configuration shown in Figure 12 where a free end 709 of the rod 701 projects from the housing 24, in particular from a surface 226' defined as in the first embodiment.

[0126] Then, an expulsion step is carried out. At the start of this step, the activation element 620, and in particular the toothed wheel 702, are in contact with the second end 805 which forms a stop preventing the movement of the activation element beyond the activation position. The control card 44 continues to control the rotation of the toothed wheel 646 in the direction corresponding to the direction of deployment of the piston 14. The activation element 620 being in abutment against the second end 805, the force exerted by the thrust element 143 increases with the displacement of the pilot element 162 along the threaded rod 161 until the moment when the force exerted exceeds the force of detachment of the piston stopper 104 with respect to the cartridge 10. The piston stopper is then set in motion by the thrust element, preferably up to the end for expelling product from the cartridge 10.

[0127] Thus, the product moves from the cartridge 10 to the cannula and therefore to the product administration site by means of the movement of the pushing element 143 and the piston stopper 104 through the cartridge 10.

[0128] Advantageously, the movement control of the control element 162 is different between the contacting step and the expulsion step. The movement of the control element is, for example, continuous during the contacting step and discontinuous during the expulsion step.

[0129] At the end of the expulsion step, the administration device 200 is in the configuration shown in FIG. 13, the thrust element 143 and the piston stopper 104 being at the product expulsion end of the cartridge 10.

[0130] Then, the electronic card 44 performs a retraction step where it controls the rotation of the toothed wheel 646 in a direction corresponding to the retraction direction of the piston, the rotation of the threaded rod 161 causes the translation of the pilot element 162 in the direction of the first orifice 208 so that the pilot element 162 drives the piston rod 141 and the thrust element 143 towards their retracted position.

[0131] During the retraction step, the spring forming the piston rod 141 operates in traction and no longer in compression, under the effect of the movement of the control element 162, and is capable of exerting a traction force on the threaded rod 161 via the control element 162, so as to move the activation element 620 from its activation position to its rest position when the control element 162 is driven in translation along the threaded rod in the direction of retraction of the piston.

[0132] At the end of the retraction step, the control system is in the rest configuration shown in Figure 10, while the piston stopper 104 remains at the product expulsion end of the cartridge 10. Thus the activation element is in its rest position as is the thrust element.

[0133] Alternatively, the control system 400 can be configured so that the translational movement of the activation element 620 from its rest position to its activation position is simultaneous with the pressing of the thrust element 143 against the piston stopper 104 of the product container 10.

[0134] A feature of the second embodiment is that the relative movement of the threaded rod 161 and the control element 162 is such that the control element remains in position along the axis X620 relative to the housing 24, while the threaded rod moves along this axis when it is driven by the motor assembly.

[0135] Thus, whatever the embodiment of the invention, the administration device 2, 200 according to the invention and in particular the control systems 4, 400 make it possible to reliably and simply control the administration of product and the insertion into a site of a product administration member such as a needle or a cannula. Furthermore, the control system according to the invention makes it possible to group together the constituent elements of the control assembly which are relatively elaborate and expensive in a reusable assembly which can be used successively with several disposable parts 6.

[0136] Whatever the embodiment, the control element 162 is advantageously configured to, when it is driven in translation along the threaded rod 161, control the activation element 20, 620 from its rest position to its activation position and from its activation position to its rest position.

[0137] Advantageously, whatever the embodiment, the passage of the activation element 20, 620 from its rest position to its activation position or the passage of the activation element 20, 620 from its activation position to its rest position is carried out by a translation along an axis X20 or X620 parallel to, in particular coincident with, an axis of movement of the control element 162, which is here the longitudinal axis X161 of the threaded rod 161. In the first embodiment, the axes X20 and X161 are parallel and offset in a direction perpendicular to the plane of FIGS. 6 to 8. In the second embodiment, the axes X620 and X161 are coincident.

[0138] Advantageously, whatever the embodiment, the direction of movement of the activation element 20, 620 along the axis X20, X620, from its rest position to its activation position, is the same as the direction of movement of the control element 162 along its axis of movement.

[0139] Advantageously, in its rest position and in its activation position, the activation element 20, 620, in particular its rod 201, 701, extends mainly along an axis parallel to, in particular coincident with, the longitudinal axis X161 of the threaded rod 161.

[0140] Advantageously, the control element 162 and the activation element 20, 620 are offset along the axis X20, X620 of movement of the activation element 20, 620. Advantageously, the control of the activation element 20, 620 by the control element 162 is mechanical control.

[0141] Advantageously, the translation of the control element 162 along the threaded rod is rectilinear.

[0142] Advantageously, the translation of the activation element 20, 620 between its rest position and its activation position is rectilinear.

[0143] Whatever the embodiment envisaged, the product administration device according to the invention can in particular be used to administer a medication in liquid form to a patient in order to treat a wide variety of pathologies such as, for example, autoimmune diseases or chronic diseases such as diabetes or associated disorders, cancers, hormonal deficiencies, macular degeneration, inflammation, atherosclerosis, rheumatoid arthritis, coronary syndromes, thromboembolic diseases, etc.

[0144] Thus, the term “medicine” refers to any liquid formulation capable of being administered continuously by means, for example, of a hollow needle or a cannula. The formulation may be a solution, a gel or even a fine suspension containing one or more active ingredients.These active ingredients may include peptides (e.g., insulin or GLP-1, their derivatives or analogues, amylin or its derivatives or analogues, gastric inhibitory peptides or their analogues), proteins, glycoproteins or hormones (e.g., hormones from the pituitary gland or hypothalamus, such as gonadotropin or gonadotropin releasing hormone, desmopressin, gonadorelin, triptorelin, terlipressin, leuprorelin, buserelin, goserelin, nafarelin, lutropin, menotropin, follicle-stimulating hormone and its analogues, follitropin, parathyroid hormone, teriparatide, abaloparatide or other analogues of parathyroid hormone, calcitonin, growth hormone, somatropin, etc.), active ingredients derived from hormones or nucleotides (e.g., DNA, RNA, oligonucleotides), enzymes, polysaccharides (e.g., glycosaminoglycans, hyaluronic acids, heparins, low molecular weight heparins and their derivatives, or sulfated or polysulfated forms of these polysaccharides), vaccines, antibodies and their analogues (e.g., denosumab, panitumumab, nutritional substances. The formulations may contain these active ingredients in the form of any pharmaceutically acceptable salt or solvate as well as any necessary and appropriate excipient.

[0145] The embodiments and variants envisaged above are capable of being combined with each other to give rise to other embodiments of the invention.

Claims

CLAIMS 1. Control system (4, 400) of a product administration device (2, 200), the control system (4, 400) comprising: a motorization assembly (12, 612) a piston (14) a control member (16) comprising: ■ a threaded rod (161) intended to be driven in rotation by the motorization assembly (12, 612), and ■ a control element (162) driven in translation along the threaded rod (161) when the threaded rod (161) is driven in rotation, to cause the displacement of the piston (14), an activation element (20, 620) of a device for inserting a needle into a site, the activation element (20, 620) being movable between a rest position and an activation position of the needle insertion device in which the control element (162) controls the movement of the activation element (20, 620) between its rest position and its activation position, when it is driven in translation along the threaded rod (161), characterized in that: the activation element (20, 620) is movable in translation between its rest position and its activation position.

2. Control system according to claim 1, in which the control element (162) controls the translational movement of the activation element (20, 620) from its rest position to its activation position and the translational movement of the activation element (20, 620) from its activation position to its rest position.

3. Control system (4, 400) according to one of claims 1 and 2, in which the piston (14) comprises: - a flexible rod (141), and - a thrust element (143) capable of acting on a piston stopper (104) of a product container (10) to expel the product from the container (10), the flexible rod (141) comprising a pilot end (141 A) intended to be in contact with the pilot element (162) and a thrust end (141 B) intended to be in contact with the thrust element (143).

4. Control system according to claim 3, wherein the flexible rod (141) is formed by a spring and the activation element (620) is fixed to the threaded rod (161), the spring being able to exert a thrust force on the threaded rod (161) via the pilot element (162), so as to move the activation element (620) from its rest position to its activation position when the thrust element (143) is resting on the piston stopper (104) and when the pilot element (162) is driven in translation along the threaded rod (161) in a direction of deployment of the piston (14).

5. Control system according to claim 4, wherein the pilot end (141 A) is fixed to the pilot element (162) and the thrust end (141 B) is fixed to the thrust element (143), and wherein the spring is capable of exerting a tensile force on the threaded rod (161) via the pilot element (162), so as to move the activation element (620) from its activation position to its rest position when the pilot element (162) is driven in translation along the threaded rod (161) in a direction of retraction of the piston (14).

6. Control system according to one of claims 1 to 3, in which the control element (162) is capable of: o moving the piston (14) to control the expulsion of the product from the container (10), when the control element (162) is driven in translation along the threaded rod (161) in a direction of deployment of the piston (14), o moving the activation element (20) from its rest position to its activation position, when the control element (162) is driven in translation along the threaded rod (161) in a direction of retraction of the piston (14).

7. Control system according to any one of the preceding claims, in which the system comprises a return element (202) capable of exerting on the activation element (20) a return force towards its rest position.

8. Control system according to claim 7, wherein the activation element (20) comprises a rod (201) around which the return element (202) extends and a shoulder (203) in contact with the return element (202).

9. Control system according to any one of the preceding claims in which the activation element (20, 620) is received in a zone (Z, Z') comprising a first end (204, 804) and a second end (205, 805) opposite along a displacement axis (X20, X620) of the activation element (20, 620), the first end (204, 804) defining a stop in contact with the activation element (20, 620) when it is in its rest position.

10. Control system according to claim 9, in which the second end (205, 805) defines: either a second stop in contact with the activation element (20), when it is in its activation position, or a support surface for a return element (202).

11. Control system according to any one of the preceding claims, in which the system comprises a first housing (24) for receiving the motorization assembly (12, 612), the control member (16) and the activation element (20, 620) and in which the first housing (24) comprises a first orifice (208) for the passage of the activation element (20, 620) capable of being crossed by the activation element (20, 620) when it is in its activation position, the activation element (20, 620) then projecting relative to the first housing (24).

12. Control system according to any one of the preceding claims, in which the system comprises a first housing (24) for receiving the motorization assembly (12, 612), the control member (16) and the activation element (20, 620) and in which the first housing (24) is capable of being removably assembled with a second housing (8) receiving the needle insertion device and advantageously a product container (10).

13. Control system according to one of claims 3 to 5, in which the system comprises a first housing (166) capable of receiving the flexible rod (141), the threaded rod (161) and the control element (162), the first housing (166) comprising a wall (167) provided with a longitudinal slot (168) and in which the control element (162) comprises a radial projection (164) intended to be received in the longitudinal slot (168), so as to block the rotation of the control element (162) relative to the first housing (166).

14. A control system according to claim 13, wherein the activation element (20) comprises a contact end (210) and an activation end (209), the contact end (210) defining a housing (211) for receiving the projection. radial (164), when the pilot element (162) drives the activation element (20) from its rest position to its activation position via the radial projection (164).

15. A product delivery device (2,200) comprising a first part provided with a control system (4,400) according to any one of the preceding claims and a second part (6) receiving the needle insertion device and a product container (10).

16. Device according to the preceding claim, in which the control system (4, 400) is according to claim 11 and the second part (6) comprises a second housing (8) for receiving the needle insertion device, the second housing (8) being intended to be removably assembled to the first housing (24), and in which the second housing (8) comprises a wall provided with a second orifice capable of being positioned opposite the first orifice (208) when the first (24) and the second (8) housings are assembled, the activation element (20, 620) being capable, when it is in its activation position, of passing through the second orifice to activate the needle insertion device and trigger the insertion of the needle into a site.

Images