System for controlling a product dosing device and associated product dosing device - Patent Application 20070122999

Abstract

The system (4) for controlling a product administration device includes a motorized assembly (12), a piston (14), a control member (16), and an activation element (20) for activating the device for inserting a needle into a site. The control member includes a threaded rod intended to be rotationally driven by the motorized assembly (12) and an actuation element (162) intended to be translated along the threaded rod when the threaded rod is rotationally driven to move the piston (14). The activation element (20) is movable between a rest position and an activated position of the needle insertion device. The actuation element (162) can similarly move the activation element (20) between its rest position and its activated position during translation of the activation element (20) along the threaded rod. The activation element (20, 620) is capable of translational movement between its rest position and its activated position.

Description

[Technical Field]

[0001] The present invention relates to a system for controlling a device for administering a product, in particular a drug intended to be administered parenterally. The present invention also relates to a device for administering a product and including a control system. [Background technology]

[0002] In the field of parenteral administration of products, particularly drugs, it is a known practice to use portable injection devices intended to be fixed to the patient's body, particularly with a patch, for the injection of drugs, i.e., intradermally, intramuscularly, subcutaneously, etc. Such devices are convenient for patients in that they allow them to administer drugs parenterally at home without the need for the patient to remain immobile for relatively long periods of time, which can amount to several hours. Furthermore, these devices advantageously allow the drug to be administered without the assistance of a caregiver.

[0003] Advantageously, some of these injection devices include a disposable component that includes a container of product and a needle insertion device, and a reusable component that can be secured to the disposable component and that includes a reusable control system, for example, for dispensing the product from the container.

[0004] In particular, WO 2017 / 219156 A1 discloses a system for controlling a product administration device, and an associated product administration device. The product administration device is intended to be secured to a patient's body, particularly by means of a patch, and includes a control system, a drug container, and a device for inserting a needle into a site. In WO 2017 / 219156 A1, the system for controlling the administration device is capable of both expelling the product from the product container and activating the device for inserting a needle into a site. However, the control system is mechanically complex, which increases costs and the risk of failure, among other things.

[0005] Additionally, US 2020 / 0114068 discloses mounting a nut onto a threaded rod of a system for controlling a product administration device and tilting and rotating a lever to enable activation of a needle insertion device. Rotating the lever takes up space, meaning that this control system is bulky and cannot be conveniently integrated into a product administration device, such as a portable medicine administration device. Other systems known from WO 2016 / 145094, WO 2022 / 104362, EP 3260146, EP 3501576 and WO 2018 / 204779 suffer from drawbacks comparable to those mentioned above. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] International Publication No. 2017 / 219156A1 Brochure [Patent Document 2] US Patent No. 2020 / 0114068 [Patent Document 3] International Publication No. 2016 / 145094 Brochure [Patent Document 4] International Publication No. 2022 / 104362 Brochure [Patent Document 5] European Patent No. 3260146 [Patent Document 6] European Patent No. 3501576 [Patent Document 7] International Publication No. 2018 / 204779 Brochure Summary of the Invention [Problem to be solved by the invention]

[0007] It is therefore an object of the present invention to provide a system for controlling a product dosing device which has a simpler construction and better reliability. [Means for solving the problem]

[0008] To that end, the present invention relates to a control system for controlling a product administration device, the control system including a drive assembly, a piston, a control member, and an activation element for activating a device for inserting a needle into a site. The control member includes a threaded rod intended to be rotationally driven by the drive assembly, and a drive element that is driven in translation along the threaded rod when the threaded rod is driven in rotation to move the piston. The drive element is movable between a rest position and an activated position for activating the needle insertion device. The drive element drives movement of the activation element between its rest position and its activated position as the activation element is driven in translation along the threaded rod. According to the present invention, the activation element is translatable between its rest position and its activated position.

[0009] According to the present invention, movement of the drive element along the threaded rod allows both expelling product from the product container and activating the needle insertion device. The structure of the control system is therefore simplified and the reliability of the system is improved because the movement of the drive element required to administer the product is also used to activate the needle insertion device.

[0010] According to various aspects of the invention, the control system comprises one or more of the following features, considered alone or in any technically possible combination: the drive element drives the translational movement of the active element from its rest position to its active position and from its active position to its rest position; the piston comprises a flexible rod and a thrust element capable of acting on a piston plunger of a container of product to expel the product from the container, the flexible rod comprising a drive end intended to come into contact with the drive element and a thrust end intended to come into contact with the thrust element; the flexible rod is formed by a spring, the active element is fixed to the threaded rod, and the spring is capable of exerting a thrust on the threaded rod via the drive element such that the thrust element presses the piston plunger and the drive element, when driven in translation along the threaded rod in the deployment direction of the piston, moves the active element from its rest position to its active position; the drive end is fixed to the drive element and the thrust end is fixed to the thrust element, and when the drive element is driven in translation along the threaded rod in the retraction direction of the piston, the spring is capable of exerting a tension force on the threaded rod via the drive element to move the active element from its active position to its rest position; the drive element is operable to move the piston to expel the product from the container when the drive element is translated along the threaded rod in a direction of piston deployment, and to move the activation element from its rest position to its activation position when the drive element is translated along the threaded rod in a direction of piston retraction; the system includes a restoring element capable of applying a restoring force to the active element to return it to its rest position; the active element comprises a rod around which the return element extends and a shoulder in contact with the return element; the active element is received in an area including a first end and a second end opposite each other along an axis of motion of the active element, the first end defining a stop in contact with the active element when the active element is in its stop position; the second end defines either a second stop in contact with the active element when the active element is in its active position or a support surface for the return element; the system includes a first casing for receiving the drive assembly, the control member, and the active element, the first casing including a first orifice for passage of the active element, the active element being able to pass through the first orifice when the active element is in its activated position, the active element then protruding from the first casing; the system comprises a first casing for receiving the drive assembly, the control member and the activation element, the first casing being removably assembleable with a second casing for receiving the needle insertion device and, advantageously, a container of the product; the system comprises a first cavity capable of receiving a flexible rod, a threaded rod and a drive element, the first cavity comprising a wall with a longitudinal slot, the drive element comprising a radial protrusion intended to be received in the longitudinal slot so as to prevent the drive element from rotating relative to the first cavity; the active element includes a contact end and an active end, the contact end defining a cavity for receiving the radial protrusion when the drive element drives the active element from its rest position to its active position via the radial protrusion.

[0011] The present invention also relates to a product administration device comprising a first part with a control system as described above and a second part for receiving a needle insertion device and a container of product.

[0012] Advantageously, the control system comprises a first casing for receiving the drive assembly, the control member and the active element, the first casing comprising a first orifice for passage of the active element, the active element being capable of passing through the first orifice when the active element is in its activated position and then protruding from the first casing, while the second part comprises a second casing for receiving the needle insertion device, the second casing intended to be removably assembled with the first casing, the second casing comprising a wall with a second orifice positionable facing the first orifice when the first and second casings are assembled, the active element being capable of passing through the second orifice when the active element is in its activated position to activate the needle insertion device and initiate insertion of a needle into the site.

[0013] The invention will be better understood and further advantages thereof will become apparent in the light of the following description, given by way of non-limiting example only with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0014] [Figure 1] 1 is a perspective view of a product dispensing device according to a first embodiment of the present invention, including a reusable control system according to a first embodiment of the present invention, the dispensing device being ready for use; FIG. [Figure 2] FIG. 2 is a perspective view of assembling disposable components on a reusable control system of the device in FIG. 1. [Figure 3] FIG. 3 is a perspective view of the reusable control system of FIGS. 1 and 2, with one half-shell of the casing omitted. [Figure 4] FIG. 4 is an exploded view of the reusable control system in FIG. 3. [Figure 5] FIG. 5 is a larger scale exploded view of detail V in FIG. 4. [Figure 6] FIG. 5 is a partial plan view of the product dosing device of FIGS. 1-2 including the reusable control system of FIGS. 3 and 4, with one half-shell of the casing omitted, a product container associated with said control system, and the control system in a stopped configuration. [Figure 7] FIG. 7 is a view similar to FIG. 6, with the control system in an active position to activate the device to insert a needle into the site. [Figure 8] 8 is a view similar to FIGS. 6 and 7, in which the control system is configured to bring the thrust element into contact with the piston plunger. [Figure 9] 9 is a view similar to FIGS. 6-8, showing the control system configured after product has been discharged from the container. [Figure 10] FIG. 10 is a partial plan view of a product dosing device according to a second embodiment of the present invention, including a reusable control system, with one half-shell of the casing omitted, a product container associated with said control system, and the control system in a stopped configuration. [Figure 11] 11 is a view similar to FIG. 10, in which the control system is configured to bring the thrust element into contact with the piston plunger. [Figure 12] 12 is a view similar to FIGS. 10 and 11, with the control system in an active position for activating the device to insert a needle into the site. [Figure 13] 13 is a view similar to FIGS. 10-12, with the control system configured after product has been dispensed from the container. DETAILED DESCRIPTION OF THE INVENTION

[0015] A product dispensing device 2, generally depicted in Figures 1 and 2, according to a first embodiment of the invention, includes a reusable control system 4 and disposable parts 6 according to a first embodiment of the invention.

[0016] The disposable part 6 comprises a casing 8 formed from two half shells 82 and 84 enclosing a cartridge 10 of the product to be administered, the cartridge being partially visible through a cut-out window 86 in the half shell 82 of the casing 8.

[0017] The cartridge 10 includes a body 102, also called the product container, made from glass or plastic material, and a sliding plunger 104, also called the "piston plunger," preferably made from an elastomer and designed to slide inside the cartridge along the longitudinal axis X10 of the cartridge 10.

[0018] In the figures, the cartridge 10 is depicted as being see-through.

[0019] At the end opposite the sliding plunger 104, the cartridge 10 is intended to be connected to a product dosing subassembly (not shown), which includes, among other things, 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 includes, for example, a needle and a cannula and a control assembly for controlling the position of the needle and cannula. The control assembly can, for example, move the needle and cannula from a retracted position, in which the needle and cannula are contained inside the casing 8, to a deployed position, in which the needle and cannula extend outside the casing 8 and can be positioned through the user's skin. The control assembly can also move the needle from the deployed position to the retracted position to maintain only the cannula within the user's skin after the needle has been inserted through the user's skin, with product being delivered to the user via the cannula. The needle insertion device follows, for example, the technical teachings of any of the documents WO-A-2021 / 224388 and WO-A-2022 / 023391. Advantageously, the needle insertion device includes a release member for releasing the needle and cannula, which when actuated via the activation element is capable of moving the needle and cannula from a retracted position to a deployed position.

[0020] Conveniently, the disposable part 6 also includes a dosing subassembly received within the casing 8 .

[0021] The part 6 is intended to be attached to the control system 4 so as to slide in the direction of arrow F1 in Figure 2 as controlled by the control system 4 when the product contained in the cartridge 10 is to be administered to a user, and then to be ejected when the cartridge 10 is emptied or when the amount of product to be administered therein reaches a predetermined minimum amount. Thus, multiple disposable parts 6 may be subsequently attached to the control system 4, and the control system 4 is reused with each of these different parts 6.

[0022] The control system 4 includes a drive assembly 12 , a piston 14 , a control member 16 , an activation element 20 for activating the needle insertion device, and conveniently a control interface 22 .

[0023] The control system 4 includes a casing 24 that is conveniently formed from two half-shells 242 and 244. As depicted in Figures 1-3, the piston 14, control member 16, and active element 20 are housed within the casing 24, and the control interface 22 is located on the exterior surface of the casing 24, for example, on half-shell 242.

[0024] The control system 4 is depicted in Figure 4 and also includes a battery 25 held in place within the half-shell 244 by a cover 26 which is attached to and held securely on the half-shell.

[0025] The drive assembly 12 includes an electric motor 42 and at least one gear set 46 driven by the motor 42 .

[0026] The motor 42 is capable of selectively driving the gear set 46 to rotate in a first direction and a second direction opposite the first direction.

[0027] The piston 14 is configured to urge the sliding plunger 104 along the axis X10 toward the product discharge end of the cartridge 10 to expel the product. The piston 14 is visible through a side opening formed on the side surface 226 of the casing 24. Movement of the piston to push the sliding plunger 104 causes the product contained within the cartridge 10 to be expelled from the cartridge 10.

[0028] The piston 14 includes a piston rod 141 and a thrust element 143 fixed to the piston rod.

[0029] The thrust element 143 can be positioned facing the sliding plunger 104 when the casing 8 and the casing 24 are assembled together. The thrust element 143 is visible through a side opening formed on the side surface 226 when the casing 24 is separated from the casing 8.

[0030] The front surface 143A of thrust element 143 is defined to be one of its surfaces that faces towards plunger 104 when parts 4 and 6 are assembled to form device 2. The back surface 143B of thrust element 143 is defined to be the surface that faces in the opposite direction to the front surface.

[0031] The piston rod 141 comprises a drive end 141 A intended to come into contact with the control member 16 and a thrust end 141 B intended to come into contact with a thrust element 143 .

[0032] In Figures 6 and onwards, piston rod 141 is depicted in the form of a centre line between its ends 141A and 141B.

[0033] The piston rod 141 is a flexible rod, for example formed by a coil spring, to which the thrust element 143 can be fixed, for example by threading the spring onto the thrust end 141B. The rotation of the spring forms, for example at the end 141B, a tapping in a mounting area 145 for mounting the thrust element 143, which can cooperate with a corresponding thread formed on a stud provided on the back side 143B of the thrust element 143.

[0034] A thrust element 143 can act on the piston plunger 104 to eject the product from the container 10. The thrust element 143 can pass through the side opening to contact the piston plunger 104 as the product is ejected from the container.

[0035] The front face 143A of the thrust element 143 is provided with a protrusion, in other words a tip 146, intended to enter a correspondingly shaped cavity 106 provided on the back side 104B of the plunger 104 facing towards the piston 14 when the product administration device 2 is configured for use.

[0036] The thrust element 143 is movable between a rest position and a plurality of operating positions. In the rest position, particularly depicted in Figure 6, the thrust element 143 presses against the casing 24 and is conveniently disengaged from the body 102 of the cartridge 10. In one of the operating positions, as represented in Figure 8, the thrust element 143 pushes the plunger 104 towards the product discharge end of the cartridge 10 and is conveniently engaged with the body 102. The plurality of operating positions of the piston 14 are distributed along an axis of movement X14 of the thrust element, which coincides with axis X10 when the product dosing device 2 is in its assembled configuration.

[0037] The control member 16 comprises a threaded rod 161 intended to be driven in rotation by the drive assembly 12, and a drive element 162 intended to be driven in translation along the threaded rod 161 as the threaded rod 161 is driven in rotation, in order to move the piston 14. The movement of the drive element 162 is parallel to the longitudinal axis X161 of the threaded rod 161.

[0038] The threaded rod 161 is associated with a gear set 46 that is rotationally driven, for example, by the electric motor 42. The gear set 46 includes, for example, a first gear 46A and a second gear 46B that mesh with each other, and the second gear 46B is fixed to the threaded rod 161 and can be rotationally driven by the electric motor 42 via the first gear 46A.

[0039] The drive element 162 is fixed to the drive end 141A of the piston rod, the end opposite the thrust end, and is able to move the piston rod 141 and, during this movement, the thrust element 143. The drive element 162 can be fixed to the spring forming the piston rod 141, for example by being threadedly engaged at the drive end 141A. The drive element 162 is formed, for example, by a nut, as shown in FIG. 5, which includes a radial projection 164 and an external thread 169 that can cooperate with the rotation of the spring at the drive end 141A, forming complementary threads for fastening the drive element 162 to the piston rod 141. The drive element 162 has an internal thread 163 provided to cooperate with the thread of the threaded rod 161.

[0040] In FIG. 5, parts 162 and 164 of drive assembly 12 are depicted twice to show their positioning relative to both threaded rod 161 and piston 14.

[0041] The radial protrusions 164 can interact with the active element 20 to move the active element 20 .

[0042] Advantageously, the control member 16 also includes a channel 165 that is configured generally in a J-shape and is capable of receiving the piston rod 141. As a result, the channel causes the piston rod to assume a curved shape when positioned therein such that the piston rod includes a first straight portion at its drive end 141A, a second straight portion at its thrust end 141B, and a curved portion connecting the first and second straight portions.

[0043] Preferably, the channel forms a first cavity 166 capable of receiving the piston rod 141, the threaded rod 161 and the drive element 162. The first cavity 166 includes a wall 167 with a longitudinal slot 168 in which a radial projection 164 of the drive element 162 is received so as to prevent the drive element from rotating relative to the first cavity and thus to prevent the drive element from rotating when the threaded rod 161 is rotated. The channel 165 is formed, for example, by two half shells, i.e. a lower half shell and an upper half shell assembled together.

[0044] The threaded rod 161 and the drive element 162 form a mechanism for converting the rotational movement output by the gear set 46 into a translational movement that is intended to be transmitted along the axis X14 to the piston 14, in particular to the thrust element 143, when the product dosing device 2 is in its assembled configuration.

[0045] In this case, the connection between elements 161 and 162 is of the screw-nut type.

[0046] The drive element 162 moved by the threaded rod 161 can therefore drive the movement of the piston 14 by acting on the drive end 141A of the piston rod 141, in particular to move the piston plunger 104 within the cartridge 10 and thus expel the product from the cartridge 10.

[0047] While being driven in translation along the threaded rod 161, the drive element 162 can also drive the translational movement of the activation element 20 between a rest position shown in FIG. 6 and an activation position for activating the needle insertion device, which is the position shown in FIG. 7.

[0048] 1-9, when motor 42 rotationally drives gear set 46 in a first direction, drive element 162 is translated along the threaded rod in the deployment direction of piston 14 to expel product from the container. In other words, drive element 162 is translated to move thrust element 143 of piston 14 toward the discharge end of cartridge 10 to expel product from cartridge 10. Thus, due to the curved shape of piston rod 141, when drive element 162 is moved in the deployment direction of the piston, thrust element 143 is moved in a direction corresponding to arrow F2 marked in FIG. 6, while drive element 162 is moved in the opposite direction corresponding to the direction of arrow F1 marked in FIG. 2 and replicated in FIG. 6.

[0049] Moreover, when motor 42 rotationally drives gear set 46 in a second direction, drive element 162 is translated along the threaded rod in the direction of retraction of piston 14, as indicated by arrow F1' in FIG. 6, so that when drive element 162, and in particular radial protrusion 164, contacts activation element 20, it retracts the piston and moves activation element 20 between a rest position and an activated position for activating the needle insertion device. In other words, drive element 162 is translated to move piston 14 away from the product discharge end of cartridge 10 toward casing 24, as indicated by arrow F2' in FIG. 6. Thus, due to the curved shape of piston rod 141, when the drive element is moved in the direction of deployment of piston 14, thrust element 143 is moved in the direction corresponding to arrow F2', while drive element 162 is moved in the opposite direction, as indicated by arrow F2 in FIG. 6.

[0050] Advantageously, while the activation element 20 is translationally moved from its rest position to its activated position, it can contact and actuate the release member to move the needle and cannula from their retracted position to their deployed position.

[0051] The activation element 20 includes, for example, a rod 201 for selectively activating a needle insertion device.

[0052] More specifically, in the first embodiment, the active element 20 includes a rod 201 around which a return element 202 extends, and a shoulder 203 extending radially from the rod 201 and in contact with the return element 202. The return element 202 can apply a return force to the active element 20 to return the active element 20 to its rest position.

[0053] More specifically, the active element 20 is received in a receiving zone Z of the casing 24, which includes a first end 204 and a second end 205 opposed to one another along the axis of motion X20 of the active element 20. The first end 204 defines a stop that contacts the active element 20 when the active element 20 is in its rest position, and the second end 205 defines a support 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 formed in the upper surface of the channel 165, for example, as shown in FIG. 5 .

[0054] Advantageously, the return element 202 is a compression spring.

[0055] In the rest position of the active element 20, the rod 201 is maintained inside the casing 24, and in its active position, the rod 201 protrudes from the casing 24, in particular from the side 226' parallel to the side 226, advantageously through a first orifice 208 for the passage of the active element, this orifice being formed through the wall of the casing 24.

[0056] Advantageously, casing 8 includes a wall with a second orifice, not depicted, which can be positioned facing first orifice 208 when casing 24 and casing 8 are assembled. When active element 20 is in its activated position, it can pass through first orifice 208 and the second orifice to activate the needle insertion device and initiate insertion of the needle into the site.

[0057] Advantageously, the active element 20 includes an active end 209 formed by the free end 201 of the rod, e.g., remote from the shoulder 203, and a contact end 210 extending away from the rod into the casing 24. The contact end 210 defines a cavity 211 for receiving the radial protrusion 164 when the drive element 162 drives the active element 20 from its rest position to its active position via the radial protrusion 164. The contact end 210 includes two arms 212 extending, e.g., from the shoulder 203, into the casing 24 and defining slots for receiving the radial protrusion 164. The active element 20 is mechanically driven by the drive element 162, as a result of which the radial protrusion 164 penetrates into the cavity 211 of the contact end 210.

[0058] Advantageously, translational movement of the active element 20 occurs in two opposing directions between its rest position and its active position. Translation from the rest position of FIG. 6 to the active position of FIG. 7 occurs when the radial protrusion 164 engaged in the cavity 211 of the contact end 210 pushes back the rod 201 of the active element 20 against the force exerted by the spring 202. Translation from the active position of FIG. 7 to the rest position of FIG. 6 occurs when the radial protrusion 164 engaged in the cavity 211 of the contact end 210 decelerates and controls the movement of the rod 201 under the action of the force exerted by the spring 202. As a result, the drive element 162 drives the translational movement of the active element 20 from its rest position to its active position, and vice versa.

[0059] The control interface 22 includes a plurality of control buttons 130 and display members 132, each of which is made up of light emitting diodes or LEDs, each associated with indicia 134 in the form of a logo indicating the parameter displayed using the display member. The control interface is capable of controlling the drive assembly 12, inter alia, via the electronic control board 44.

[0060] The control board 44 is configured to activate the motor 42 based on commands received by the interface 22 to return the thrust element 143 of the piston 14 to its rest position when the product contained in the cartridge 10 is completely used up or a predetermined amount is used up.

[0061] The elements that make up the reusable control assembly 4 are relatively sophisticated and expensive, and therefore it is advantageous to continue using them with some disposable components 6 .

[0062] 3 and 4 are used to securely hold half shells 242 and 244 together. In the first embodiment depicted, screws 50 pass through corresponding cavities provided in half shell 244 and thread into corresponding tappings in half shell 242. Other means of assembling the half shells with one another are contemplated, particularly elastic clip fastening assembly means.

[0063] As can be more typically seen from Figure 2, the casing 8 of the disposable part 6 is provided with a hook 88 which forms a fastening member for holding the parts 4 and 6 together when the product administration device 2 is in an assembled configuration. The hook 88 is in one piece with the half shell 84 and includes a head 882 and a handle 884 which connects the head 882 to the remainder of the half shell 84.

[0064] Additionally, as depicted in Figure 3, the half-shell 244 includes a rigid portion 136 that defines a ramp 138 for the head 882 to slide against during movement of parts 4 and 6 together in the direction of arrow F1 in Figure 2. The rigid portion 136 also defines a capture surface 140 that is perpendicular to axis X14 and against which the head 882 abuts when parts 4 and 6 of the product dispensing device 2 are in their assembled configuration.

[0065] The push button 52 is mounted in the casing 24 and includes a head 522, the outer shape of which is preferably convex and which is received in a cavity of corresponding shape, which cavity is defined by the two half shells 242 and 244. When the push button 52 is not acted on by the user, the outer surface 522S of the head 522, i.e., the surface of this head that is visible from outside the casing 24, is flush with the outer surface of the casing 24.

[0066] The longitudinal axis A52 of the push button 52 is labeled A52.

[0067] The push button 52 also includes a rod 524 that extends along the longitudinal axis A52.

[0068] When the reusable control assembly 4 is in the installed configuration, axis A 52 overlaps with axis X 24 defined by the casing 24 and is the axis about which the push button 52 within the casing 24 slides.

[0069] By default, the push button 52 is pushed back by the two springs 54 to the position of Figures 1 to 3, in which its rod 524 does not interact with the hook 88 and the surface 522S is flush with the outer surface of the casing 24.

[0070] The outer surface 522S of the head 522 bears indicia 532 depicting a padlock that serves as a signal that the push button 52 can unlock the disposable part 6 from the reusable control system 4. Specifically, when the head 522 is depressed into the cavity by applying a force E1 to its surface 522S directed toward the inside of the casing 24, the push button 52 applies a force with the end 525 of the rod 524 that is oriented and strong enough to push the head 882 of the hook 88 back so that it disengages from the capture surface 140.

[0071] Movement of the head 882 of the hook 88 upon actuation of the push button 52 is achieved as a result of elastic deformation of the curve of the stem 884 of the hook 82 .

[0072] Thus, the push button 52 can translate along the coincident axes A52 and X24 between a first, locking position and a second, disconnecting position. In its first position, when parts 4 and 6 are assembled, the push button 52 does not contact the hook 88, meaning it is disengaged from the 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, together with the capture surface 140, a receiving area for receiving the hook 88. In its second position, the push button is seated within the hook receiving area. Thus, when parts 4 and 6 are assembled and the push button is then moved toward its second position, the end 525 of the push button's rod 524 pushes back the head 882 of the hook 88 against the elastic force exerted by the rod 884 to disconnect the disposable part 6 from the reusable control system 4.

[0073] In other words, the push button 52 can initiate the separation of the parts 4 and 6 of the product dosage device 2 from the assembled configuration depicted in Figure 1. The securing of the parts 4 and 6 of the product dosage device 2 together can be obtained by means of the hooks 88, and vice versa.

[0074] Operation of the dispensing device, and in particular operation of the control system according to the first embodiment, is described below using Figures 6 to 9, which depict the control system in various configurations corresponding to the various steps of operating the control system 4 to dispense product to a user.

[0075] In a first actuation step, after the control system 4 has been assembled with the disposable part 6 as depicted in Fig. 2, the control system 4 is in the rest configuration depicted in Fig. 6. In the rest configuration, the thrust element 143 is positioned facing the piston plunger 104 and away from it. Furthermore, the active element 20 is in a rest position positioned inside the casing 24, and the drive element 162 is positioned via the radial protrusion 164 in the cavity 211 for receiving the radial protrusion.

[0076] The user then positions the administration device against their skin at the site of injection and secures it, for example using a patch system secured to the surface of the casing 8 intended to come into contact with the user's skin.

[0077] During the next activation step, the user administers the product by, for example, activating one of the buttons 130 of the control interface 22. During this step, a command to activate administration is transmitted from one of the buttons to the control board 44, which then moves the activation element 20 from its rest position to its activated position. At the end of this activation step, the control system is in its activated configuration depicted in FIG. 7. To do so, the control board 44 rotates the gear set 46 in a second direction to rotationally drive the threaded rod 161 and translate the drive element 162 in the direction of the arrow F1′ marked in FIG. 6 toward the first orifice 208, so that the radial projection 164 moves the activation element 20, and in particular the rod 201, toward the needle insertion device so that its end 209 contacts the release member and can pass the needle and cannula toward the deployed position, i.e., through the user's skin. The drive element 162 applies a force to the active element 20 that is greater than the force applied by the return element 202, such that the active element 20 is moved from its rest position to its active position. In the active configuration, the rod 201 protrudes from the casing 24, particularly from the side surface 226', particularly through the first orifice 208 and the second orifice.

[0078] Then, during the step of bringing the piston 14, particularly the thrust element 143, into contact with the piston plunger 104, the control board 44 rotates the gear set 46 in a first direction to rotationally drive the threaded rod 161 and translate the drive element 162 in a direction away from the first orifice 208, so that the drive element 162 moves in the deployment direction of the piston 14. During this step, the drive element 162 applies a thrust force to the piston rod 141, which transmits this force to the thrust element 143, which moves toward the piston plunger 104 and comes into contact with it.

[0079] While the drive element 162 moves towards a configuration that brings the piston 14, and in particular the thrust element 143, into contact with the piston plunger 104, the drive element 162 tends to move away from the active element 20. The return element 202 exerts a force on the rod 201, moving it towards its rest position and bringing the active element into contact with the radial projection 164. During this step, when the active element returns to its rest position, the drive element 162 continues to move in the direction of the deployment of the piston 14, in the direction of the arrow F1 marked in FIG. 6, and the radial projection 164 leaves the cavity 211 as depicted in FIG. 8.

[0080] FIG. 8 depicts the control system in its contact configuration obtained at the end of the contact step when the thrust element 143 moves into contact with the piston plunger 104 via the drive element 162 .

[0081] Thereafter, once the control system 4 is in its contact configuration, an ejection step occurs. During this step, the control board 44 rotates the gear set 46 in a first direction to rotationally drive the threaded rod 161 and translate the drive element 162 away from the first orifice 208 in the direction of arrow F1 marked in FIG. 6, so that the drive element 162 moves in the deployment direction of the piston 14 and drives the movement of the piston plunger 104 in the direction of arrow F2 marked in FIG. 6, to the end where the product is ejected from the cartridge 10. As a result, the product is ejected from the cartridge into the cannula and thus through the cartridge 10 to the product administration site using the movement of the thrust element 143 and the piston plunger 104.

[0082] Advantageously, the drive element 162 is moved differently between the contact step and the ejection step: the movement of the drive element is for example continuous during the contact step and interrupted during the ejection step.

[0083] At the end of the ejection step, the dispenser returns to the configuration depicted in FIG. 9, with the thrust element 143 and piston plunger 104 once again approaching the product ejection end of the cartridge 10.

[0084] The control board 44 then performs a retraction step in which it rotates the gear set 46 in a second direction so as to rotationally drive the threaded rod 161 and translate the drive element 162 in the direction of the arrow F1' marked in Figure 6 toward the first orifice 208, so that the drive element 162 drives the piston rod 141 and the thrust element 143 toward their retracted positions in the direction of the arrow F2' marked in Figure 6.

[0085] At the end of the retraction step, the control system returns to the rest configuration depicted in FIG. 6, while the piston plunger 104 remains at the product dispensing end of the cartridge 10.

[0086] Components 4 and 6 can then be separated by pressing push button 52 and component 6 can be discarded. For the next use of control system 4, a new disposable component 6 can be connected to it.

[0087] Advantageously, between the contacting step and the discharging step, the control system 4 can perform a step of opening a closing membrane for closing the cartridge 10, which is intended to close the product discharging end of the cartridge 10. To that end, during this step, the control board 44 rotates the gear set 46 in a first direction, causing the drive element 162 to translate in the direction of deployment of the piston 14, in the direction of the arrow F1 marked in Figure 6, in order to apply a force to the piston plunger 104 so as to increase the pressure inside the cartridge until the membrane deforms and opens. The membrane can be opened, for example, using an opening needle positioned facing the membrane and able to pierce it when it deforms under the effect of increasing pressure inside the cartridge 10.

[0088] As a result, the administration device 2 according to the present invention, and in particular the control system 4, allows for reliable and simpler control of the administration of product and the insertion of a product administration member, such as a needle or cannula, into a site. Furthermore, such a control system allows for the relatively sophisticated and expensive components of a control assembly to be grouped together into a reusable assembly 4 that can subsequently be used with multiple disposable parts 6.

[0089] A second embodiment of a control system 400 for controlling the product dosing device 200 is depicted in Figures 10-13.

[0090] In the remainder of the description of the second embodiment, elements similar to the first embodiment will have the same reference numerals, and only elements that are different will be described and will have different reference numerals.

[0091] More particularly, in this second embodiment, the disposable part 6 is similar to the disposable part of the first embodiment, and the control system 400 also includes a drive assembly 612 and an active element 620 that are different from the first embodiment, as well as a piston 14, a control member 16 and a control interface 22 that are similar to the piston, control member and control interface of the first embodiment.

[0092] The drive assembly 612 includes an electric motor 642 and at least one gear 646 driven by the motor 642 .

[0093] The motor 642 can selectively drive the gear 646 to rotate in a first direction and a second direction opposite to the first direction.

[0094] Active element 620 includes rod 701 and gear 702 that meshes with gear 646. Rod 701 includes, for example, a free active end 709 and a contact end 710 where gear 702 extends radially on rod 701.

[0095] Active element 620 is fixed to threaded rod 161. Rod 701 is fixed to threaded rod 161 such that when gear 646 is driven in rotation by motor 642, gear 702 is also driven in rotation as is threaded rod 161.

[0096] Active element 620 is received within receiving zone Z', which includes a first end 804 and a second end 805 opposed to one another along axis of motion X620 of active element 620. First end 804 defines a stop that contacts active element 620, particularly gear 702, when active element 620 is in its rest position. Second end 805 defines a stop that contacts active element 620, particularly gear 702, when active element 620 is in its active position.

[0097] In this second embodiment, the spring forming the flexible rod 141 can exert a thrust on the threaded rod 161 via the drive element 162 such that the thrust element 143 presses against the piston plunger 104 as depicted in FIG. 11 and the drive element 162 translates the active element 620 from its rest position to its active position when the drive element 162 is driven in translation along the threaded rod in the deployment direction of the piston 14.

[0098] In addition, the spring forming the flexible rod 141 can also apply a tensile force to the threaded rod 161 via the drive element 162 so as to move the active element 620 from its active position to its rest position when the drive element 162 is driven in translation along the threaded rod 161 in the retraction direction of the piston 14.

[0099] As a result, the drive element 162 drives the translational movement of the active element 620 from its rest position to its active position, and vice versa.

[0100] The operation of the dispensing device 200, and in particular the operation of the control system 400 according to the second embodiment, will be described below using Figures 10-13, which depict the control system 400 in various configurations corresponding to the various steps of operating the control system 400 to dispense a product to a user. Where a reference number is described in the following part of this description without being featured in Figures 10-13, it refers to the same element as the element having the same reference number in the first embodiment. Conversely, where a reference number is described in one of these figures without being featured in the description, it refers to an element similar to the element having the reference number in the first embodiment.

[0101] In a first actuation step, the control system is associated with the disposable part 6 and is in the rest configuration depicted in Figure 10. In the rest configuration, the thrust element 143 is positioned facing and away from the piston plunger 104 and is preferably surrounded by the wall of the casing 24 which defines the opening for receiving the cartridge when the casings 24 and 8 are assembled. Furthermore, the activation element 620 is in its rest position inside the cartridge 24.

[0102] The user then positions the administration device 200 against their skin at the injection site and secures the administration device 200, for example using a patch system that is secured to the surface of the casing 8 that is intended to come into contact with the user's skin.

[0103] The user then dispenses the product, for example, by activating one of the buttons 130 on the control interface 22. This results in the next step of placing the piston in contact with the piston plunger. During this step, the control board 44 rotates the gear 646 in a direction corresponding to the deployment direction of the piston 14. Rotation of the threaded rod 161 then translates the drive element 162 away from the first orifice 208, which moves in the direction of deployment of the piston 14, as indicated by the arrow F1 in FIG. 10 . During this step, the drive element 162 exerts a thrust on the piston rod 141, which transmits this force to the thrust element 143, which moves in the direction of the arrow F2 in FIG. 10 toward and into contact with the piston plunger 104.

[0104] FIG. 11 depicts the control system 400 in its contact configuration obtained at the end of the contact step when the thrust element 143 has moved into contact with the piston plunger 104 via the drive element 162 .

[0105] Thereafter, once the control system 400 is in its contact configuration, the needle insertion step is performed.

[0106] During the needle insertion step, gear 646 continues to rotate in a direction corresponding to the deployment direction of piston 14, and drive element 162 then translates in the deployment direction of piston 14. Drive element 162 then exerts a thrust on the spring forming piston rod 141, which is compressed as long as the force exerted by piston 14 on piston plunger 104 is less than the release force that separates piston plunger 104 from its starting position relative to cartridge 10. As a result, under the effect of the compression exerted by drive element 162, the spring forming piston rod 141 exerts a thrust on threaded rod 161 via drive element 162, moving threaded rod 161, and thus activation element 620, from its rest position to its activated position. The control system is then in its needle insertion configuration depicted in FIG. 12 , in which free end 709 of rod 701 protrudes from casing 24, and in particular from surface 226′ defined in the first embodiment.

[0107] The ejection step then occurs. At the beginning of this step, the activation element 620, specifically gear 702, contacts the second end 805, which forms a stop that prevents the activation element from moving beyond the activated position. The control board 44 continues to rotate the gear 646 in a direction corresponding to the direction of deployment of the piston 14. As the activation element 620 abuts the second end 805, the force exerted by the thrust element 143 increases with the movement of the drive element 162 along the threaded rod 161 until the applied force exceeds the peel force of the piston plunger 104 against the cartridge 10. The piston plunger is then set by the thrust element to move, preferably to the end where the product is ejected from the cartridge 10.

[0108] As a result, product is expelled from the cartridge 10 into the cannula and thus through the cartridge 10 to the product administration site using the movement of the thrust element 143 and the piston plunger 104 .

[0109] Advantageously, the drive element 162 is moved differently between the contact step and the ejection step: the movement of the drive element is for example continuous during the contact step and interrupted during the ejection step.

[0110] At the end of the ejection step, the dosing device 200 returns to the configuration depicted in FIG. 13, with the thrust element 143 and piston plunger 104 returning to the product ejection end of the cartridge 10.

[0111] The electronic board 44 then performs a retraction step in which the gear 646 rotates in a direction corresponding to the retraction direction of the piston, and the rotation of the threaded rod 161 translates the drive element 162 toward the first orifice 208 so that the drive element 162 drives the piston rod 141 and thrust element 143 toward their retracted positions.

[0112] During the retraction step, the spring forming the piston rod 141, under the influence of the movement of the drive element 162, operates in tension and no longer in compression, and when the drive element 162 is driven in translation along the threaded rod in the retraction direction of the piston, a tensile force can be applied to the threaded rod 161 via the drive element 162 so as to move the active element 620 from its active position to its rest position.

[0113] At the end of the retraction step, the control system returns to the rest configuration depicted in Figure 10, while the piston plunger 104 remains at the product discharge end of the cartridge 10. As a result, the activation element returns to its rest position, as does the thrust element.

[0114] As a variant, 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 simultaneously presses the thrust element 143 against the piston plunger 104 of the product container 10 .

[0115] One particular feature of the second embodiment is that the relative movement of the threaded rod 161 and the drive element 162 causes the drive element to remain in position along axis X620 relative to the casing 24, while the threaded rod moves along that axis when driven by the motor assembly.

[0116] As a result, regardless of the embodiment of the invention, the administration device 2, 200 according to the invention, and in particular the control system 4, 400, allows for reliable and simpler control of the administration of product and the insertion of a product administration member, such as a needle or cannula, into a site. Furthermore, the control system according to the invention allows for the relatively sophisticated and expensive components of a control assembly to be grouped together into a reusable assembly that can subsequently be used with multiple disposable parts 6.

[0117] Regardless of the embodiment, the drive element 162 is advantageously configured, when driven in translation along the threaded rod 161, to drive the active element 20, 620 from its rest position to its active position and from its active position to its rest position.

[0118] Advantageously, regardless of the embodiment, the passage of the active element 20, 620 from its rest position to its active position or from its active position to its rest position is effected by a translational movement along the axis of movement of the drive element 162, in this case an axis X20 or X620 parallel to the longitudinal axis X161 of the threaded rod 161, in particular coinciding with the longitudinal axis X161. In a first embodiment, the axes X20 and X161 are parallel and offset in a direction perpendicular to the plane of Figures 6 to 8. In a second embodiment, the axes X620 and X161 coincide.

[0119] Advantageously, regardless of the embodiment, the direction of movement of the active element 20, 620 along the axis X20, X620 from its rest position to its active position is the same as the direction of movement of the drive element 162 along its axis of movement.

[0120] Advantageously, in its rest position and in its active position, the active element 20, 620, in particular its rod 201, 701, extends mainly along an axis parallel to the longitudinal axis X161 of the threaded rod 161, in particular coinciding with the longitudinal axis X161.

[0121] Advantageously, the drive element 162 and the active element 20,620 are offset along the axis of motion X20,X620 of the active element 20,620.

[0122] Advantageously, the active element 20 , 620 is mechanically driven by a drive element 162 .

[0123] Advantageously, the drive element 162 is translated linearly along a threaded rod.

[0124] Advantageously, the active element 20, 620 is translated linearly between its rest position and its active position.

[0125] Regardless of the embodiment considered, the product administration device according to the present invention may be particularly used to administer medicines in liquid form to a patient to treat a wide variety of conditions, such as, for example, autoimmune diseases or chronic diseases such as diabetes or related disorders, cancer, hormone deficiencies, macular degeneration, inflammation, atherosclerosis, rheumatoid arthritis, coronary syndromes, thromboembolic diseases, and others.

[0126] The term "medicament" therefore refers to any liquid preparation that can be administered continuously, for example using a hollow needle or cannula. The liquid preparation may be a solution, gel or other fine suspension containing one or more active ingredients. These active ingredients may be, in particular, peptides (e.g. insulin or GLP-1, derivatives or analogues thereof, amylin or derivatives or analogues thereof, gastric inhibitory peptide or analogues thereof), proteins, glycoproteins or hormones (e.g. hormones derived from the pituitary gland or the hypothalamus, e.g. gonadotropins or gonadotropin-releasing hormones, desmopressin, gonadorelin, triptorelin, terlipressin, leuprorelin, buserelin, goserelin, nafarelin, lutropin, menotropins, hormones secreted from ovarian follicles, and and analogs thereof, follitropin, parathyroid hormone, teriparatide, abaloparatide or other parathyroid hormone analogs, calcitonin, growth hormone, somatropin, etc.), hormone- or nucleotide-derived active ingredients (e.g., DNA, RNA, oligonucleotides), enzymes, polysaccharides (e.g., glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin and derivatives thereof, or sulfate or polysulfate forms of these polysaccharides), vaccines, antibodies and analogs thereof (e.g., denosumab, panitumumab), and nutritional substances. The liquid preparation may contain these active ingredients in the form of any pharmaceutically acceptable salt or solvate, together with any necessary and appropriate excipients.

[0127] The above-discussed embodiments and variations can be combined with each other to provide other embodiments of the present invention.

Claims

1. A control system (4, 400) for controlling a product dosing device (2, 200), said control system (4, 400) comprising: a drive assembly (12, 612); - a piston (14), a control member (16), a threaded rod (161) intended to be rotationally driven by said drive assembly (12, 612); a control member (16) including a drive element (162) that is driven in translation along the threaded rod (161) when the threaded rod (161) is driven in rotation, in order to move the piston (14); an activation element (20, 620) for activating a device for inserting a needle into a site, said activation element (20, 620) being movable between a rest position and an activation position for activating said needle insertion device; the drive element (162) drives the movement of the active element (20, 620) between its rest position and its active position as the active element (20, 620) is driven in translation along the threaded rod (161); A control system (4, 400) characterized in that said active element (20, 620) is capable of translational movement between its rest position and its active position.

2. 2. The control system of claim 1, wherein the drive element (162) drives the translational movement of the active element (20, 620) from its rest position to its active position and the translational movement of the active element (20, 620) from its active position to its rest position.

3. The piston (14) - a flexible rod (141), - includes a thrust element (143) capable of acting on the piston plunger (104) of said container (10) of product in order to expel the product from said container (10); 3. A control system (4, 400) as claimed in claim 1 or 2, wherein the flexible rod (141) comprises a drive end (141A) intended to contact the drive element (162) and a thrust end (141B) intended to contact the thrust element (143).

4. 4. The control system of claim 3, wherein the flexible rod (141) is formed by a spring, the active element (620) is fixed to the threaded rod (161), and the spring can apply a thrust to the threaded rod (161) via the drive element (162) so as to move the active element (620) from its rest position to its active position when the thrust element (143) presses the piston plunger (104) and the drive element (162) is driven in translation along the threaded rod (161) in the deployment direction of the piston (14).

5. 5. The control system of claim 4, wherein the drive end (141A) is fixed to the drive element (162) and the thrust end (141B) is fixed to the thrust element (143), and the spring can apply a tensile force to the threaded rod (161) via the drive element (162) so as to move the active element (620) from its active position to its rest position when the drive element (162) is driven in translation along the threaded rod (161) in the retracting direction of the piston (14).

6. The driving element (162) - when the drive element (162) is driven in translation along the threaded rod (161) in the direction of deployment of the piston (14), it moves the piston (14) to expel the product from the container (10); A control system as claimed in any one of claims 1 to 3, wherein the drive element (162) is capable of moving the activation element (20) from its rest position to its activation position when the drive element (162) is driven in translation along the threaded rod (161) in the retraction direction of the piston (14).

7. The control system according to any one of claims 1 to 6, wherein the system includes a return element (202) capable of applying a return force to the active element (20) to return the active element (20) to its rest position.

8. 8. The control system of claim 7, wherein the active 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. 9. The control system according to claim 1, wherein the active element (20, 620) is received in a region (Z, Z') including a first end (204, 804) and a second end (205, 805) opposite each other along the axis of motion (X20, X620) of the active element (20, 620), the first end (204, 804) defining a stop in contact with the active element (20, 620) when the active element (20, 620) is in its stop position.

10. The second end (205, 805) a second stop in contact with said active element (20) when said active element (20) is in its active position, or A control system according to claim 9, which defines one of the support surfaces for the return element (202).

11. 11. The control system of claim 1, wherein the system includes a first casing for receiving the drive assembly, the control member, and the active element, the first casing including a first orifice for passage of the active element, the active element being able to pass through the first orifice when the active element is in its activated position, and the active element then protruding from the first casing.

12. 12. The control system of any one of claims 1 to 11, wherein the system includes a first casing (24) for receiving the drive assembly (12, 612), the control member (16) and the active element (20, 620), the first casing (24) being removably assembleable with a second casing (8) for receiving the needle insertion device and, advantageously, a container (10) of product.

13. 6. The control system of claim 3, wherein the system comprises a first cavity (166) capable of receiving the flexible rod (141), the threaded rod (161), and the drive element (162), the first cavity (166) comprising a wall (167) with a longitudinal slot (168), the drive element (162) comprising a radial protrusion (164) intended to be received in the longitudinal slot (168) so as to prevent the drive element (162) from rotating relative to the first cavity (166).

14. 14. The control system of claim 13, wherein the active element (20) includes a contact end (210) and an active end (209), the contact end (210) defining a cavity (211) for receiving the radial protrusion (164) when the drive element (162) drives the active element (20) from its rest position to its active position via the radial protrusion (164).

15. A product administration device (2, 200) comprising a first part having a control system (4, 400) according to any one of claims 1 to 14, and a second part receiving the needle insertion device and a container of product (10).

16. 16. The device of claim 15, wherein the control system (4, 400) is as described in claim 11, and wherein the second part (6) includes a second casing (8) for receiving the needle insertion device, the second casing (8) intended to be removably assembled with the first casing (24), the second casing (8) including a wall with a second orifice that can be positioned facing the first orifice (208) when the first casing (24) and the second casing (8) are assembled, and the activation element (20, 620) can pass through the second orifice to activate the needle insertion device and initiate insertion of the needle into the site when the activation element (20, 620) is in its activated position.

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