Transdermal drug administration device

Abstract

The present invention relates to a transdermal drug administration device comprising: a housing; a battery; an injection system; a movable connection part for providing fluid connection between the injection system and a reservoir containing an active ingredient intended to be administered; a pump system connected to the movable connection part and to the injection system by virtue of flexible pipes so as to produce a fluid network, the pump system being motorised so as to cause a fluid to circulate within this network; and an electronic system for controlling the driving of the pump system, said electronic system being provided with a mechanical switch for powering the pump system with battery. The invention is characterised in that the movable connection part has at least one degree of freedom relative to the housing on one side and the reservoir on the other in order to allow a movement, the movable connection part jointly controlling the fluid supply of the pump and the power supply of the electronic system during said movement, at least part of the movement of the movable connection part being performed by a human mechanical action. The movable connection part comprises a means for fluid connection between the reservoir and the pump, providing disconnection at rest and fluid communication during said movement. The movable connection part comprises a means for activating the electrical power supply of the electrical and electronic components of the device, providing disconnection at rest and supplying power during said movement.

Description

Transdermal drug delivery device Field of invention

[0001] The present invention relates to the field of external transdermal drug delivery systems, incorporating a pump system and a transdermal administration system. Typically, the system is integrated into a housing whose interior maintains the sterility of the fluidic, self-contained portion that adheres to the abdomen or chest or the like of the patient and delivers the substance to the patient via a cannula that is inserted into the patient subcutaneously,

[0002] Medical treatment of many diseases requires continuous infusion of medication, through subcutaneous and intravenous injections, particularly for drugs that contain large molecules that cannot be digested when administered orally, such as insulin, biological drugs or biosimilars.

[0003] Patients with chronic illnesses such as immuno-oncology or those requiring recurrent post-operative treatment require bolus injections of medications, which are generally administered by healthcare personnel. The quantity of these medications injected can vary from a few milliliters to several tens of milliliters. Since the flow rate is capped to be tolerated by the patient, the injection time increases proportionally with the volume injected and has a direct impact on the occupancy rate of the healthcare personnel.Automatic drug injection pumps have been developed to, on the one hand, free up time for healthcare staff when administration via the pump must be supervised by trained personnel, and on the other hand, allow the patient to self-administer the medication safely thanks to an automatic system with simplified operation, allowing them to achieve daily autonomy, drastically reducing the necessary frequency of hospital visits.

[0004] Basal and / or bolus volumes must be administered in precise doses according to the individual prescription. Therefore, drug injection pumps must be highly reliable, ensuring the accuracy and correct monitoring of the administered dose for the patient and caregivers.

[0005] These pumps are also used for the injection of biological drugs, or anticancer active ingredients, requiring shorter injection times, from a few tens of minutes to a few hours, at shorter intervals, weekly or monthly.

[0006] To avoid the problems of resterilizing ambulatory devices intended for home treatments, single-use devices are preferred; the simplicity of the device components is therefore essential to ensure a non-prohibitive selling price.

[0007] Typically, the patient fills the reservoir with the active ingredient, for example from a vial, attaches the needle and delivery tube to the reservoir outlet, and then inserts the reservoir into the pump housing. After purging the air from the reservoir, tube, and needle, the patient inserts the needle assembly, penetrating element, and cannula into a selected location on the body and removes the penetrating element. To avoid irritation and infection, the subcutaneous cannula should be replaced and discarded, along with the empty reservoir.

[0008] It also happens that the patient or the caregiver uses an additional transfer station so that the contents of the vial are automatically transferred into the internal reservoir of the medical device. To do this, the user must generally successively connect the vial (and the vial adapter if it is not already integrated into the transfer station) on one side and the medical device on the other side, to the transfer station and then start the transfer sequence.

[0009] These devices have an internal power source that powers the internal organs while the drug is being injected into the patient. Since these devices can be stored for long periods of time, it is crucial to preserve the power source during this period and only power the system when needed. State of the art Vial connection

[0010] Known in the prior art is patent application US2013253427 describing a drug dispensing device, which comprises a key validation portion and a security portion. The key validation portion is configured to interact with a key portion of another component of the drug dispensing device during assembly of the drug dispensing device. To support the use of matching components, the security portion is configured to have a different impact if the key portion matches the key validation portion, compared to the case where the key portion does not match the key validation portion.

[0011] Patent application US2020023123 describes a drug delivery system and components thereof. The system may include an on-body pump device and a secondary unit. The on-body pump device may include a reservoir and a fluid path. The reservoir may be configured to contain a liquid drug. The secondary unit may be removably coupled to the on-body pump device. The secondary unit may be configured to receive a pre-filled cartridge containing a liquid drug, expel the liquid drug from the pre-filled cartridge, and deliver the liquid drug to the reservoir of the on-body pump device via the fluid path. This is a solution formed by two assembled parts, namely an on-body pump device 301 and a secondary unit 305, to form the injection arrangement, unlike the invention. In addition, it never provides a movable bottle receiving part.The receiving part is formed by a fixed cavity. This solution is not compatible with fluid communication via a vial. It requires a special bottle with a pierceable base. This solution also requires piercing the base with two needles, one for the air inlet to compensate for the volume of liquid transferred.

[0012] Patent application US2020146938 describes a disposable fluid transfer and mixing device that includes an injector support surface for receiving an injection device thereon. A lyophilized drug vial, a diluent vial, and a syringe are also attached to the device. The device includes fluid passages and a manual valve that can be manipulated such that the syringe can be used to transfer a diluent from the diluent vial to the lyophilized drug vial, for reconstitution of the drug. The valve can also be configured such that the reconstituted drug is transferred from the lyophilized drug vial to the injection device.An automated transfer and mixing device receives an injection device, a vial of lyophilized drug, and a vial of diluent and transfers the diluent from the vial of diluent to the vial of lyophilized drug and shakes or vibrates the vial of lyophilized drug to reconstitute the drug.

[0013] Patent application US2020368447 describes a housing and an activation button assembly movably mounted thereon and movable from a non-actuated position to an actuated position. A cartridge door is configured to receive therein a cartridge containing a substance to be dispensed, and is movably mounted to the injector housing between open and closed positions. A deflectable interference element is mounted within the injector housing and, in a rest position, blocks movement of the activation button assembly from the non-actuated position to the actuated position thereof. The activation button assembly is configured to activate the injector when in the actuated position, and is movable from the non-actuated position to the actuated position only upon deflection of the interference element from its rest position.The cartridge door, when in its closed position with the cartridge received inside, deflects the interference element out of its rest position. Disadvantages of the prior art Vial connection

[0014] Known devices of the prior art propose to tension the device when removing the seal protecting the part of the device to be affixed to the patient and for which sterility must be ensured until the last moment. This solution is satisfactory in its context, but is incompatible with a device with a removable bottle which potentially requires the filling of an internal reservoir before injection. Indeed, filling the internal reservoir is a slow operation which is carried out by a pumping mechanism which needs to be electrically powered. Based on this known technique, the patient would be obliged to remove the seal to turn on the pumping system, immediately apply the device to his skin and wait for the pumping operation to complete before the injection takes place.This results in unnecessary immobilization of the patient during an automatic operation for which their presence is not essential.

[0015] The removable bottle devices known from the prior art do not propose solutions to avoid the device being inadvertently tensioned by linking it to a crucial step that is not subject to incorrect handling. If the devices of the prior art make it possible to satisfactorily secure the step of filling the internal reservoir after insertion of the bottle, this is ensured by the use of sensors that must be powered. Thus, in this context, the prior art does not propose to guarantee the connection of the device to its energy source only during an essential step of the injection procedure that cannot be triggered inadvertently.

[0016] In particular, patent application US2013253427 describes a solution with a system for verifying the conformity of the bottle / device pair using an electromechanical coding system. This solution implies that the electronic circuit must first be started before being able to use the signals provided by these indexes. As with other prior art solutions, there is a risk of untimely power consumption, resulting in a reduction in the lifespan and autonomy. Solution provided by the invention

[0017] In order to address the drawbacks of the prior art, the present invention relates, in its most general sense, to a transdermal drug delivery device having the technical characteristics set out in claim 1.

[0018] It comprises a housing, a battery, an injection system, a movable connecting piece to ensure the fluid connection between the injection system and a reservoir containing an active ingredient intended to be administered, a pump system connected to the movable connecting piece and to the injection system by means of flexible tubing so as to create a fluid network, the pump system being motorized in order to circulate a fluid within this network, an electronic system to control the motorization of the pump system, said electronic system being provided with a mechanical switch for its powering up to said battery, The movable connecting piece has at least one degree of freedom relative to the housing on the one hand and the reservoir on the other hand to allow movement, the movable connecting piece jointly controlling the fluid supply of the pump and the powering up of said electronic system during said movement,at least part of said movement of the movable connecting part being carried out by a human mechanical action, said movable connecting part comprising a means of fluid connection between said reservoir and said pump on the one hand ensuring a disconnection at rest and a fluid communication during said movement, said movable connecting part comprising a means of activating the electrical supply of the electrical and electronic components of said device ensuring a disconnection at rest and the supply during said movement.,

[0019] In a variant, the movable connecting part is also intended to receive the reservoir in the form of a bottle removable relative to the transdermal drug delivery device, the movable connecting part being moved according to said at least one degree of freedom, when receiving said reservoir.

[0020] In addition, the connection of the tank to the mobile connecting piece is made by means of an adapter piece, previously connected to the tank, the mobile connecting piece and the adapter piece having complementary central tubes which fit together to create a watertight connection.

[0021] In addition, the additional central pipes can achieve the watertight connection by conical fitting.

[0022] In particular, the conical fitting made by the complementary central tubes can be of the “luer” type.

[0023] In a variant, the movement stroke of the movable connecting part, according to said at least one degree of freedom, has a notch at the end of the stroke to lock the movable connecting part in the final position, the notch requiring an additional torque to be passed and reach the final position, the switch being activated in the final position.

[0024] In particular, the excess torque required to pass the notch and reach the final displacement position of the movable connecting part is greater than the nominal tightening torque for screwing the adapter part with the movable connecting part, ensuring the tightness of the fitting of the central pipes.

[0025] In another variant, the movable connecting part has a cylindrical body provided with a thread, the adapter part having a hollow cylindrical protuberance into which the central tube extends, said hollow cylindrical protuberance having on its internal surface a thread cooperating with the thread to ensure the sealed fitting of the central tubes by screwing the adapter part with the movable connecting part, the seal being guaranteed beyond a nominal tightening torque of the screwing.

[0026] In particular, said degree of freedom of the movable connecting piece for activating the switch may be a degree of freedom in rotation achieved by guiding the movable connecting piece in the lower casing of the housing, the travel of movement of the movable connecting piece being angular, and in that the movable connecting piece has a partial annular protuberance axially extending the cylindrical body over a limited angular portion, said partial annular protuberance being capable, at the end of travel, of activating the switch located in radial proximity to the movable connecting piece.

[0027] In one variant, the movement path of the movable connecting part is covered by the rotational movement leading to the screwing of the adapter part with the movable connecting part.

[0028] In a variant, the movable connecting piece has two cylindrical axial protuberances extending from the cylindrical body, these axial protuberances extending into the lower casing of the housing and simultaneously coming into abutment against beads during the travel of the movable connecting piece, the beads being protrusions of flexible beams integral with the lower casing, the abutment position of the axial protuberances against the beads being able to be exceeded by elastic deformation of the flexible beams, being elastically deformable, to reach the final position of displacement of the movable connecting piece, said notch thus being produced by the elastic deformation of the flexible beams.

[0029] In all variants, the screwing of the adapter piece with the movable connecting piece can be carried out by the user.

[0030] In particular, the deformation and release of the flexible beams, when the user applies the excess torque to move the notch, provides haptic information indicating the activation of the switch and therefore of the device.

[0031] In another variant, the movable connecting piece has a radial protrusion and a partial annular protrusion, the final position of the movable connecting piece being achieved by bringing said radial protrusion and the partial annular protrusion into contact respectively against complementary stops of the lower casing of the housing.

[0032] In another variant of an injection device with a pre-filled internal reservoir, the movable connecting part is provided with a hollow needle connected to a flexible tube, said hollow needle being able to be inserted into the reservoir during a translational movement of the movable connecting part to reach a final state.

[0033] Furthermore, the translational movement is induced by a spring.

[0034] More particularly, in the initial state, the movable connecting part does not have a degree of freedom in translation, but only a degree of freedom in translation, and in that the spring is in a compressed state.

[0035] More precisely, a first rotational movement of the movable connecting part is carried out by a mechanical action of the patient to bring the movable connecting part into an intermediate state for which it acquires the degree of freedom in translation allowing the insertion of the hollow needle into the reservoir.

[0036] Detailed description of a non-limiting example of embodiment

[0037] For a better understanding of the invention, and to show how embodiments thereof may be implemented, reference will now be made, by way of example, to the accompanying drawings in which:Theshows a top view of the locking device of the insertion mechanism in the initial state,theshows a top view of the locking device of the insertion mechanism in the final state,theshows the needle insertion mechanism alone in perspective and partial sectional view,theshows a perspective view of the locking mechanism associated with the pump system in partial sectional view and housed in the lower casing of the housing,theshows a side view of the pump system associated with the locking mechanism,theshows a perspective view of the complete fluidic system integrated in the lower casing of the housing,theshows a side sectional view of the pump,theshows a top view of the pump body from which the valve piston protrudes,lapresents a front sectional view of the pump,lapresents two pump hole shapes for connecting the tubing and the fluid passage sections obtained for different positions of the valve piston,la,laand,lapresents a perspective view of the fluid system compatible with an external reservoir for different stages of reservoir insertion, lashowing all the elements before assembly, lashowing the reservoir positioned in the adapter piece and lashowing the reservoir and adapter piece assembly assembled to the movable connecting piece and in the final position,lapresents a side sectional view of the adapter piece and the movable connecting piece,lapresents the movable connecting piece in a side view,laand,lapresents top views of the movable connecting piece integrated in the lower casing of the housing respectively in the initial and final position of the activation stroke,laand,lapresents top sectional views of the movable connecting piece integrated in the lower casing of the housing respectively in the initial and final position of the activation stroke,lapresents a top sectional view of an alternative embodiment of the movable connecting piece integrated in the lower casing of the housing in the initial position,lapresents a perspective view of a second alternative embodiment of the device with a pre-filled internal reservoir,lapresents a top view of the second alternative embodiment with a pre-filled internal reservoir in the initial state,lapresents a side sectional view of the second alternative embodiment with a pre-filled internal reservoir in the initial state, ,lapresents a top view of the second alternative embodiment with a pre-filled internal reservoir in the final state,shows a sectional side view of the second embodiment with a pre-filled internal reservoir in the intermediate state. Detailed description of the multifunctional operation and the release of the insertion mechanism controlled by the piston rod,

[0038] Figures 1, 2, 3, 4, and 5 illustrate a first embodiment of the needle insertion mechanism locking device according to the invention, lrepresenting the needle insertion mechanism alone, as described in international patent application WO2018141697A1. Figures 2 and 3 show the needle locking and insertion mechanism in a top view, lrepresenting the device in the initial, so-called "cocked" state, and lrepresenting the mechanism after triggering and needle insertion. Lrepresents the needle locking and insertion mechanism in a perspective view and lrepresents the needle locking and insertion mechanism, without the cam element, in a side view.

[0039] The injection system (100) comprises in particular a needle insertion mechanism composed of a cam element (101), and illustrated in more detail with a partial sectional view. This cam element (101) has a rib (103) whose advantageous profile cooperates with protrusions (111, 112) of a needle support (121) and a cannula support (124) allowing the insertion of the needle (120) and the flexible cannula (122), then the withdrawal of the needle (120) alone, in a rotational movement of less than 360° of the cam element (101). The cannula support (124) has a conduit for receiving the tube (130) conveying the fluid to be injected through the cannula (122), this conduit being connected to the cannula (122) by an internal cavity (125). The insertion of the needle (120) and the cannula (122) is guided by a through hole (108) of the lower casing (107) of the housing.The rotational movement of the cam element (101) is induced by a spiral spring (102), preloaded in the initial state, the cam element (101) being held in position by a locking system (110) described more particularly in Figures 2, 3, 4 and 5. The needle insertion sequence (120) is triggered by a release of the locking system (110), allowing free rotation of the cam element (101) and therefore insertion of the needle (120) thanks to the discharge of the spring (102). It should be noted that this movement sequence is irreversible and that at its completion, the spring (102) is in the discharged state and opposes the movement of the cam (101) in the direction opposite to that traveled for the insertion of the needle (120) and the cannula (122).Thus, the needle (120), once the sequence is completed, is retracted inside the medical device and cannot be deployed again, leaving the device in a state avoiding any risk of injury to the user. The use of a retractable needle (120) housed within a flexible cannula (122) is not limiting of the invention and is especially useful for guaranteeing the sterility of the fluid conduit as long as the needle is located within the cannula. Those skilled in the art could easily imagine other alternatives for producing the fluid interface between the device and the patient.

[0040] More particularly, the locking device comprises a translation element (104) and a rotary element (105) both guided by the lower casing (107) of the housing in respective translation and rotation movements.

[0041] The translation element (104) has an arm (140), the distal end of which rests on a lateral surface (109) of the cam element (101), more visible on the, and the proximal end rests on a surface (150) of the rotation element (105), and an elastic protrusion (142) ensuring that the locking device (110) is held in its final position after triggering, by cooperation with the groove (172) of the lower casing (107) of the housing. Said rotation element (105) has a surface (151) opposite said surface (150), this opposite surface (151) resting on a protuberance of the lower casing (107) of the housing. Thus, in the locked position, the cooperation of the translation element (104) and the rotation element (105) makes it possible to transmit the entire preload force of the spiral spring (102), exerted on the cam (101), directly to the lower casing (107) of the housing, thus preventing any possible movement.This also ensures a longer life of the system during a storage period, the use of direct load absorption by the housing avoids the risk of creep of the parts.

[0042] The release of the locking device (110) is possible by moving the rotation element (105). Said rotation element (105) has a body (152) provided with a lever arm (153) ensuring rotational guidance of said body (152) around the axis (154). The rotation of the rotation element (105) induces sliding of the surface (150) and of the opposite surface (151) on the facing surfaces (141, 174) belonging respectively to the translation element (104) and to the lower casing (107) of the housing.

[0043] When the rotation of the rotation element (105) is sufficient so that the surface (150) is no longer in contact with the surface (141) of the translation element (104), the locking mechanism (110) is released and the translation element (104) performs a translational movement induced by the preload force of the spiral spring (102). During the translational movement of the translation element (104), the arcuate profile (143) of the elastic protrusion (142) slides along the grooves (171, 172) of the housing, causing a displacement of the end of the elastic protrusion orthogonal to the translational movement of the translation element.When the top (144) of the arcuate profile (143) exceeds the separation (175) between the two grooves (171, 172), the translation element (104) is no longer in contact with the cam (101), but the translation movement continues along the groove (172) thanks to the release of the elastic energy accumulated by the elastic protrusion (142) during its movement along the first groove (171), to finally arrive at the stable equilibrium position shown in. During the translational movement of the translation element (104), the lower surface (145) of the translation element (104) slides on an upper surface (155) of the rotation element (105) so as to impose a movement of said rotation element (105) until it abuts against a protuberance (173) of the lower casing (107) of the housing.The complementary profile of the surfaces (145, 155) advantageously allows the continuity of the translation of the translation element (104) following this stop, while making it possible to block the rotational movement opposite the stop in the final position as presented in.

[0044] Thus, the elastic protrusion makes it possible, after release of the locking device, to ensure a final safety position for which the immobilization of the translation element (104) and the rotation element (105) is ensured even in the event of sudden movement or impact on the medical device.

[0045] Before the locking device is released, the translation element (104) and the rotation element (105) are held in position by the friction of the surface (150) and the opposite surface (151) respectively on the surfaces (141, 174). The rotation of the rotation element (105) and therefore the release of the locking device is achieved by the end of the pump piston (205) pressing on a circular surface (156) of the lever arm (153). In the embodiment shown, this support is obtained on an extreme part of the movement stroke of the pump piston (205), this advantageously making it possible to perform the pumping function before the locking device is released, making it possible, for example, to transfer the fluid to be injected from an external reservoir to an internal reservoir before the device is placed on the patient.During this operation the stroke of the pump piston can easily be limited by software.

[0046] Of course, once the locking device (110) is triggered by a first movement of the pump piston (205) on the extreme part of its stroke, the pump piston (205) can benefit from the entire stroke for the pumping function and thus increase, for each pump cycle, the volume transferred from the internal reservoir to the patient.

[0047] Note that the pump piston (205) only ensures the rotational movement of the rotation element (105) until the locking mechanism (110) is released, as described above. In order to ensure the free movement of the piston over this extreme stroke, it is necessary, after release of the locking device (110), to maintain the rotation element (105) in the safety position as permitted here by its cooperation with the translation element (104).

[0048] Detailed description of the oblong hole pump body

[0049] An embodiment of the pump system (200) is to be appreciated with regard to figures 6 to 10. L represents the pump system (200) integrated in the lower casing (107), connected to the reservoir (203) of fluid to be extracted and to the internal reservoir (215). L represents the pump system (200) in side view in section showing the fluid circuit. L represents the pump body (201) seen from the side from which the valve piston (202) emerges. L represents the pump system (200) in radial section, the pump body (201) being cut along two axially offset planes to show the ports (212 and 213) simultaneously. Figures 10a to 10d highlight the geometry of the three ports (21, 212, 213) of the pump body (201) and their advantage over those used in international patent application WO2018141697A1.

[0050] More particularly, and as shown in Figures 6 and 7, the pump is composed of a pump body (201) and two pistons, a pump piston (205) and a valve piston (202), defining between them an internal cavity (208) of variable volume. These two pistons are respectively secured to a rack (248, 258) which can be set in axial movement by a drive system (240, 250) composed of a mechanical movement reducer (241, 251), the input of which is coupled to an electric motor (242, 252). The transfer of fluid within the internal cavity (208) is possible by the cooperation of multiple ports (211, 212, 213) with an internal channel (209) of the valve piston (202) opening at one end into the internal cavity (208) and terminated by an orifice (221) at its other end. The precise axial positioning of the valve piston (202) makes it possible to selectively bring into cooperation one of the ports (211, 212, 213) with the orifice (221) of the pump.

[0051] In the example of the, the port (211) is connected to the reservoir (203) of fluid to be extracted, for example a bottle, the port (212) is an outlet port and is connected to the injection system, the port (213) is connected to the internal reservoir (215) of the medical device. The port (211) and the port (213) can serve alternately as an inlet port or an outlet port. An outlet port of the pump is understood to mean a port from which the fluid circulates exclusively so as to leave the internal cavity (208) of the pump. In the initial state, the valve piston (202) and the pump piston (205) are in frontal contact or have a small distance apart, so that the internal cavity (208) has a small air volume.

[0052] Two injection sequences are preferred without being limiting of the invention. Either with use of the internal reservoir or by direct injection.

[0053] The first injection sequence involves transferring the liquid from the vial to the internal reservoir, and then transferring the liquid from the internal reservoir to the injection system. The first pumping sequence is then broken down into the following steps:moving the valve piston (202) and the pump piston (205) in a synchronized manner, by their respective drive system (240, 250) to match the orifice (221) of the pump with the port (211) connected to the reservoir (215),moving the pump piston (205) alone, thanks to the drive system (250), so as to increase the volume of the internal cavity (208) located between the valve piston (202) and the pump piston (205), this creating a depression leading to the suction of the liquid from the reservoir (203) towards the internal cavity (208) through the internal channel (209),once the internal cavity is completely filled, moving the pistons (202, 205) in a synchronized manner, using their respective drive system (240,250) so as to match the orifice (221) of the pump with the port (213) connected to the internal reservoir (215),translate the pump piston (205), alone, by its drive system (250), so as to reduce the volume of the internal cavity (208) in order to expel all of the fluid contained in the internal cavity (208) through the internal channel (209) and towards the internal reservoir (215),once the expulsion of the liquid is complete, repeat the previous steps successively until all of the liquid contained in the reservoir (203), or a predetermined quantity, is transferred into the internal reservoir (215).,

[0054] Once the fluid has been fully transferred into the internal reservoir (215), the injection into the patient can begin. The first step is therefore to trigger the needle insertion system, as for example described in international patent application WO2018141697A1. Once the cannula is inserted into the subcutaneous tissues, a new pumping sequence takes place according to the following steps:move the valve piston (202) and the pump piston (205) in a synchronized manner, by their respective drive system (240, 250) to match the orifice (221) of the pump with the port (213) connected to the internal reservoir (215),move the pump piston (205) alone, thanks to the drive system (250), so as to increase the volume of the internal cavity (208) located between the valve piston (202) and the pump piston (205),this creating a depression leading to the suction of the liquid from the internal reservoir (215) towards the internal cavity (208) through the internal channel (209), once the internal cavity is completely filled, moving the pistons (202, 205) in a synchronized manner, using their respective drive system (240, 250) so as to match the orifice (221) of the pump with the port (212) connected to the injection system, translating the pump piston (205), alone, by its drive system (250), so as to reduce the volume of the internal cavity (208) in order to expel all of the fluid contained in the internal cavity (208) through the internal channel (209) and towards the injection system. once the expulsion of the liquid is complete, repeat the previous steps successively until all of the liquid contained in the internal reservoir (215), or a predetermined quantity, is transferred in the patient.,

[0055] The second injection sequence does away with the transfer of fluid into the internal reservoir. The first step therefore consists of triggering the needle insertion system, as described for example in international patent application WO2018141697A1. Once the cannula is inserted into the subcutaneous tissues, a pumping sequence is performed according to the following steps:moving the valve piston (202) and the pump piston (205) in a synchronized manner, by their respective drive system (240, 250) to match the orifice (221) of the pump with the port (211) connected to the reservoir (203),moving the pump piston (205) alone, thanks to the drive system (250), so as to increase the volume of the internal cavity (208) located between the valve piston (202) and the pump piston (205), this creating a depression leading to suction of the liquid from the reservoir (203) towards the internal cavity (208) through the internal channel (209),once the internal cavity is completely filled, moving the pistons (202, 205) in a synchronized manner, using their respective drive system (240, 250) so as to match the orifice (221) of the pump with the port (212) connected to the injection system, translating the pump piston (205), alone, by its drive system (250), so as to reduce the volume of the internal cavity (208) in order to expel all of the fluid contained in the internal cavity (208) through the internal channel (209) and towards the injection system. once the expulsion of the liquid is complete, repeating the previous steps successively until all of the liquid contained in the reservoir (203), or a predetermined quantity, is transferred into the patient.,

[0056] These two injection sequences are not limiting of the invention and other alternatives can be envisaged. The pump system (200) can in particular be used for drug reconstitution functions, for example to reconstitute a lyophilized drug and a diluent. The internal reservoir (215) could then be a cartridge pre-filled with a diluent, and a pump sequence could be carried out to transfer this diluent to a reservoir (203) containing a lyophilized drug in order to dissolve it. Once the lyophilized drug is dissolved, the reverse transfer, i.e. from the reservoir (203) to the internal reservoir (215), is carried out in order to inject it into the patient subsequently. It is also conceivable to carry out several successive transfers, partial or total, between the reservoir (203) and the internal reservoir, this being able to facilitate the dissolution of the lyophilized drug in the diluent.

[0057] An alternative would be to completely dispense with the external reservoir (203), the internal reservoir (215) being a cartridge pre-filled with the fluid to be injected. In this case, the fluid is transferred from the internal reservoir (215) to the internal cavity and then to the injection system. This sequence of steps is repeated as many times as necessary.

[0058] As more particularly visible in the, the ports (211, 212, 213) are arranged in a staggered manner, the ports (211 and 213) being in the same longitudinal plane, the port (212) being radially offset and being located axially between the two ports (211 and 213). This staggered configuration is particularly advantageous for limiting the stroke required by the valve piston (202) to select one of the ports (211, 212, 213), this procedure having to be repeated several times during an injection cycle, the axial approximation of the ports (211, 212, 213) has a direct influence on the durability of the battery (260) and therefore affects the overall efficiency of the device. The counterpart is that the axial dimension of the ports is limited and therefore the axial positioning of the valve piston (202) must be more precise, poor positioning resulting in a reduction of the fluid passage section.Depending on the viscosity of the fluid, this can lead to significant pressure losses and therefore a reduction in fluid flow.

[0059] It is retained from this principle that the positioning of the orifice of the pump valve piston opposite one of the ports is a critical point of the current state of the art, as achieved in the international patent application WO2018141697A1. Ensuring a minimum fluid passage section in the event of axial "poor positioning" of the piston has the advantage of making the system more stable, robust and of limiting pressure losses, thus guaranteeing the accuracy of the flow rate, the quantity of medication injected to the patient, as well as the injection time. The invention proposes to overcome this problem by suggesting two improvements that can be used independently or in combination.

[0060] Figures 8 and 9 highlight one of these improvements. The staggered arrangement of the ports (211, 212, 213) results in a tangential misalignment of these holes relative to the orifice (221) of the valve piston (202). Thus, in order not to reduce the flow rate of the pump, the orifice (211) of the valve piston (202) has on either side a tangential flare (223, 224) of its radial end opposite the ports (211, 212, 213). These flares are delimited by tangential beads (225, 226) and axial beads (227, 228) made of a flexible and deformable material, such as a silicone or a flexible thermoplastic, in order to fit the cylindrical inner surface of the pump body (201) and ensure sealing. For this purpose, the valve piston has a hard core (230), in which the internal conduit (209) connected to the orifice (221) is made, this hard core (230) being overmolded by an elastomer (229) to form the tangential flares (223, 224).The valve body is shown in radial section, this section not being made in the same axial plane for the left and right halves, but according to two half-planes located respectively at the middle of the port (212) and the port (213). This section makes it possible to visualize the correct correspondence between the tangential flares (223, 224) and the ports (212, 213) offset tangentially with respect to the orifice (221) of the valve piston (202).

[0061] The second improvement to improve the tolerance to the positioning of the valve piston is shown in Figures 7, 8 and 10. In particular, the ports (211, 212, 213) of the pump body (205) are extended by tapered clearances (231, 232, 233) allowing coupling with the cylindrical flexible tubes (261, 262, 263), visible in, connecting elements of the fluidic system while ensuring a radial stop of these tubes thanks to a shoulder (220, 222). Consequently, the diameter of the ports (211, 212, 213) must be less than the outside diameter of the flexible tubes and ideally greater than the inside diameter of the flexible tube so as not to limit the flow rate. If the shoulder makes it possible to secure the mechanical assembly, it is nevertheless not necessary for it to be present over the entire circular periphery of the flexible tube.Thus the ports (211, 212, 213) can advantageously have an oblong periphery to increase the cross-section opposite the orifice of the valve piston (202) while providing a mechanical stop for the flexible tubing.

[0062] By oblong periphery is meant that the section of the ports (211, 212, 213), as presented in the, is not disc-shaped but has a different length according to the axial and tangential directions. In the example of figures 8, and sub-figures c and d of the, the section is a groove according to the tangential direction, terminated by two half-cylinders. Nevertheless, the invention is not limited to this type of shape, but includes any type of section of elongated shape, such as a rectangle or an ellipse. Also, the great length is not limited to the tangential direction, but can also be produced according to the radial direction and will be chosen according to the arrangement of the ports (211, 212, 213).

[0063]

[0064] Figure 10 illustrates different positioning scenarios of the valve piston (202), subfigures a and b representing the case of an orifice (221) and a port (211) both with a disc section, as realized in the patent application WO2018141697A1. Subfigure a represents a cylindrical port (211) having a section of for a diameter of and being perfectly aligned on an identical orifice (221), the fluid passage section is represented by hatching. The sub-figure figure b represents the evolution of the hatched passage section when there is an axial misalignment between the orifice (221) and the port (211), it can be noted that an offset of results in a remaining passage section of , a reduction of more than 35%. The oblong shape of the port (211) according to the invention is shown in sub-figures c and d, it makes it possible to provide a fluid passage section of in the same axial space when combined with an identical orifice or a disc orifice with a tangential flare as shown. Sub-figure d represents the evolution of the hatched passage section during incorrect axial positioning of the pump. It should be noted that for an offset of , the section then decreases to leave a passage of . It should also be noted that up to an axial offset of , or a passage section of the passage section remains greater than or equal to that obtained for a disc section port of the same axial size. This means that even with an offset of , corresponding to a limit tolerance, the shape of the present invention makes it possible to ensure a fluid passage section equivalent to the cylindrical shape of a tube with Ø as implemented in the prior art. The form of the present invention therefore allows for precise positioning at without having an impact on the pressure losses in said system.

[0065] It should be noted that the invention is not limited to an oblong shape, but can be extended to any shape making it possible to increase the fluid passage section while ensuring the radial stop of the pipes connected to the pump body.

[0066] Detailed description of tank insertion activation

[0067] The medical device according to a variant of the invention, to be appreciated through Figures 11 to 20, is capable of interfacing with an external reservoir (203), such as a bottle. To simplify the use of the device and its reliability, the bottle must be coupled to an adapter part (311) intended to be inserted into a movable connecting part (308) of the medical device, having complementary shapes. In the example of the, the adapter part (311) has a hollow needle (315) intended to pierce the septum of the reservoir (2203), or bottle, and collect the fluid contained therein, the hollow needle (315) being connected to a central channel of the adapter part (311).This operation is carried out before the activation of the medical device and the configuration of the septum and the needle are such that only the flow of fluid through the internal channel is possible, this making it possible to prevent air from entering the reservoir (203) and therefore preventing the spontaneous flow of the fluid contained in the reservoir (203). The activation of the medical device is obtained by inserting said adapter part (311) into the movable connecting part (308). For this purpose, the adapter part (311) and the movable connecting part (308) can be screwed into each other so as to make central tubes (320, 321) complementary to each of the parts cooperate so as to provide a sealed flow channel for conveying the fluid between the bottle and the medical device.In the example presented, the central tubes (320, 321) cooperate by conical fitting and make a luer-type connection, but the invention extends to any type of connection compatible with medical applications. When screwing the adapter part (311) into the movable connecting part (308), the torque exerted by the adapter part (311) on the movable connecting part (308) causes the latter to rotate in order to activate the electronic system (310) and to authorize the transfer of the medication to the internal reservoir as described in international patent application WO2018141697A1. Once the medication has been transferred, the user can disconnect the adapter part (311) by unscrewing it, this movement then causing the movable connecting part (308) to return to its initial position and simultaneously deactivating the electronic system (310).During the activation and deactivation sequence of the system by the described means, the user may be informed about the state of the medical device by haptic or visual signals, such as vibrations or the powering of LEDs. The triggering of said signals may be directly activated by the user's actions on the device.

[0068] Figures 11 to 13 represent the isolated fluidic system (300) of an exemplary embodiment according to the invention. Figures 11 and 13 are perspective views showing the different steps of connecting an external reservoir (203), showing an exploded view of the different unconnected elements, showing the connection of the reservoir (203) to the adapter part (311) and showing the connection of the reservoir (203) and adapter part (311) assembly to the movable connecting part (308). These different figures also show the other components of the fluidic system, namely the fluidic part of the pump system (200), the internal reservoir (215) and the needle support (121) of the injection system, these different elements being connected by flexible tubes, one end of which is inserted into clearances (231, 233) of the pump body (201).The fluid is directed towards one or other of the elements thanks to the movements of the valve piston (202) and the pump piston (205) described in this application. It shows in particular the presence of a hollow needle (315), intended to pierce the septum of the external reservoir to make a sealed connection between said external reservoir (203) and the piping of the fluidic system (300). The assembly shown is obtained, from the, following the screwing of the adapter part (311) and the movable connecting part (308) by cooperation of a thread (331) and a tapping (330).

[0069] The illustration shows a sectional view of the adapter part (311) and the movable connecting part (308) before assembly, in order to better visualize the fluid connection between these parts and their connection. In particular, the complementary central tubes (320, 321) belonging respectively to the adapter part (311) and to the movable connecting part (308) make it possible to ensure the connection of the fluid outlet port (313) of the adapter part (311) to the inlet port (387) of the movable connecting part (308). The hollow needle (315) of the adapter part (311) has an internal channel terminated by the outlet port (313) opening into the central tube (320). The movable connecting part (308) is formed of a cylindrical body (341) having a cavity opening axially into which the central tube (321) extends, the internal cylindrical surface of the cavity having the tapping (330) cooperating with the thread (331) of the adapter part (311).At its other axial end, the movable connecting piece (308) has a hollow axial protuberance (386) with a slightly conical periphery so as to be able to easily fit into a flexible tube, to ensure the transfer of the fluid to the pump body. The movable connecting piece is thus axially traversed by a conduit opening on the one hand, onto the inlet port (387) at an axial end of the central tube (321), and on the other hand, onto an outlet port (388) located at the end of the axial protuberance (386).

[0070] The central tubes (320, 321) have an advantageously conical shape, known as a "luer taper", allowing a sealed coupling, in compliance with the ISO 80369 standard, when a sufficient contact force is ensured. The fitting of the complementary central tubes (320, 321) and the application of force necessary for sealing are ensured thanks to the cooperation of a thread (331) complementary to a tapping (330), respectively made in the hollow cylindrical protuberance (340) of the adapter part (311) and in the cylindrical body (341) of the movable connecting part (308), surrounding the central tubes (320, 321). Thus, once the adapter piece (311) and the movable connecting piece (308) are assembled, any fluid entering through the hollow needle (315) is conducted to the outlet port (388) without any further leakage.The movable connecting part (308) makes it possible to ensure and secure the fluid supply of the pump system (200) with the reservoir (203) containing the medication.

[0071] It should be noted that the arrangement of this connection is not limiting of the invention, the person skilled in the art being able to easily imagine alternatives for pipes of two complementary parts in a sealed manner by a screwing method.

[0072] This allows the movable connecting piece (308) shown in Figures 11 to 14 to be appreciated in more detail. In the upper part of this figure, the central tube (321) emerging from the hollow cylindrical body (341) having the thread allowing screwing with the adapter piece (311) is notably visible. The cylindrical body (341) intended to guide the rotation of the movable connecting piece (308) by cooperation with an annular protrusion of the lower casing (107) of the housing is also shown.Finally, in order to ensure that rotation stops once the adapter part (311) has been completely screwed into the movable connecting part (308) by the user, two cylindrical axial protrusions (381, 382) extend from the cylindrical body (341), these axial protrusions (381, 382) are located radially on either side of the axial protrusion (386) and are intended to extend into the lower casing (107) of the housing, so as to cooperate with an elastically deformable part, to ensure that the final angular position of the movable connecting part is maintained. Said final angular position is obtained by the stop of a radial protrusion (383), extending radially from the lower axial end of the cylindrical body (341), against a complementary stop of the lower casing of the housing.Finally, it may be noted the presence of a partial annular protuberance (384) axially extending the cylindrical body (341) over a limited angular portion. This partial annular protuberance (384) is called the activation arm and makes it possible to engage or release the activation switch of the medical device depending on the angular position of the movable connecting part (308). The partial annular protuberance (384) also has a concentric cylindrical inner surface of a cylindrical protrusion of the lower casing of the housing, in order to ensure a return to guiding in rotation of the movable connecting part (308).

[0073] Figures 16 and 18 show the movable connecting piece (308) installed in the lower casing (9) of the housing in its initial state, that is to say before the insertion of the tank fitted with its adapter piece. Lshowing a view in axial incidence and lshowing a sectional view, at the level of the axial protuberances (381, 382), according to the same incidence. During screwing, the adapter piece (311) is inserted axially into the movable connecting piece (308), the movable connecting piece remaining fixed, until the central pipes are in coaxial contact so as to generate a jamming. Therefore, if an additional torque is applied to the adapter part (311), this torque is transmitted to the movable connecting part (308) whose rotation is stopped by the axial protrusions (381, 382) pressing against the flanges (912, 913) of the lower casing (107) of the housing.Said beads (912, 913) are protrusions located in flexible beams (922, 923) which can be elastically deformed by the axial protuberances (381, 382), as soon as a threshold torque is applied, allowing the movable connecting part to rotate until the radial protuberance (383) comes into abutment, together with the partial annular protuberance (384) against complementary stops (915, 916) of the lower casing (107) of the housing. This final position is represented by figures 17 and 19 corresponding respectively to figures 16 and 18. It can be noted that the axial protrusions (381, 382) can deform as an alternative or in addition to the flexible beams (922, 923) to allow rotation of the movable connecting part (308) when a torque greater than the threshold torque is applied to the latter.

[0074] When the movable connecting piece (308) rotates, the partial annular protrusion (384) will press against the lever of the switch (390) for activating the medical device arranged on the electronic system (310). At the end of the movement, the radial protrusion (383) and the partial annular protrusion (384), when they are in respective contact with the complementary stops (915, 916), make it possible to absorb excess torque supplied by the user to the movable connecting piece (308), making it possible to prevent this excess torque from being passed on to the axial protrusions (381, 382), thus avoiding damaging them.

[0075] Note that the deformation torque required to rotate the movable connecting part (308) is greater than the minimum torque required to ensure the connection is watertight according to the ISO 80369 standard. This deformation serves as haptic feedback to the user to indicate the successful completion of the installation of the reservoir (203) and the activation of the medical device.

[0076] It should also be noted that the final angular position is not irreversible. If the user applies a torque of identical amplitude to that deployed for activation of the device, but in the opposite direction, the flexible beams (922, 923) can again be elastically deformed by the axial protrusions (381, 382), allowing the movable connecting part to perform a reverse rotation to return to the initial state presented in 18. This operation is accompanied by the disarming of the switch (390) signaling to the medical device that the bottle is no longer engaged. The user has the option of continuing to unscrew the adapter part (311) to remove the reservoir (203).

[0077] This activation system thus offers a function guaranteeing the user a monitored and secure insertion of the bottle to limit any risk of misuse. Indeed, the fluidic connection of the pump system (200) with the reservoir (203) and the powering up of the electronic system (310) supplying said pump system (200) are both carried out by the same movable connecting part (308), during the same operation, it is impossible for the device to initiate a pumping and injection sequence without the cartridge being correctly inserted, as it is also impossible for the fluidic contact to be made and for the injection to be triggered a long time later, for example several days, eliminating any risk of mishandling or contamination.

[0078] Lapresents an alternative embodiment of the flexible beams (922, 923), the latter no longer having a central bead but an arcuate shape ending in a free end (932, 933). Lashows a sectional view of the movable connecting piece (308) at the axial protuberances (381, 382) and installed in its initial state, that is to say before the insertion of the reservoir (203) provided with its adapter piece (311). In this initial position, the axial protuberances (381, 382) are respectively in abutment with the free ends (932, 933). The rotation of the movable connecting piece (308) during the screwing of the bottle is allowed by the elastic deformation of the flexible beams (922, 923) by displacement of their free end (932, 933) in a centrifugal manner.Once sufficient deformation has been applied, the axial protrusions (381, 382) can be housed at the base (942, 943) of the flexible beams, causing a release of the elastic stress and the return of the free ends (932, 933) to the initial position. This configuration makes it possible to provide a hard point in the bottle insertion procedure to provide haptic feedback to the user once the elastic release of the flexible beams (922, 923) is complete. This configuration is advantageous compared to the previous embodiment because it makes it possible to provide an asymmetry of the force required to screw the bottle, of the force required to unscrew it. Indeed, the elastic deformation of the beams is much easier when it is carried out from the base of the beam towards its end than the reverse.By suitably choosing the curvature of the flexible beams (922, 923) and the profile of the surface of the free ends (932, 933) in contact with the axial protuberances, it is possible to obtain screwing torques that are very different from the unscrewing torques, for example more than twice as high. This is particularly advantageous for ensuring perfect completion of the unscrewing sequence of the tank (203). Indeed, the screwing torque required to pass the hard point produced by the flexible beams is of an amplitude very close to that of the tightening torque of the adapter part (311) in the movable connecting part (308).An unscrewing torque to pass the hard point of the same amplitude, could cause the unscrewing of the adapter part (311) relative to the movable connecting part (308) before passing the hard point generated by the flexible beams, leaving the movable connecting part (308) in the final state and therefore the device activated while the tank is removed.

[0079] Activation by tearing off the protective cover

[0080] According to a particular embodiment variant, presented in figures 21 to 25, the transdermal drug delivery device is provided with an internal reservoir (203) only pre-filled with the drug to be injected. Indeed, the embodiment previously presented and provided with an external reservoir has an operation of filling the internal reservoir which requires the pump system. This operation can be slow and time-consuming for medical personnel, but can also be subject to handling errors. An alternative is therefore to dispense with these steps in order to offer the patient a device which already contains the appropriate drug and which minimizes the number of manipulations required. This device is pre-loaded by a qualified person and kept sterile until its use by the patient.To limit the risk of contamination, the drug is stored in a sealed inner vial until a hollow needle (315) penetrates through the reservoir septum.

[0081] As in the previous embodiment, this hollow needle (315) is connected by a flexible tube (231) to the pump system (200), itself connected to the injection system (100) (not shown). This embodiment also has a movable connecting part (308) allowing the fluidic connection of the pump system (200) with the reservoir (203), and the powering up of the electronic system (310) supplying said pump system (200).

[0082] This embodiment nevertheless differs from the embodiment shown in Figures 6 to 20 in that the reservoir (203) does not have an adapter part (311) and the hollow needle (315) is directly supported by the movable connecting part (308). As more particularly shown in Figures 22 to 25, this movable connecting part (308) has a complex movement broken down by a first rotational movement, carried out thanks to a mechanical action of the user, followed by a translational movement carried out by the relaxation of a spring (350) preloaded during the storage period of the device. Figures 22 and 24 represent the injection device seen from above and with the cover open, respectively in the initial and final positions of the activation procedure.Figures 23 and 25 show the injection device seen from the side, perpendicular to the hollow needle (315), and with the cover open, respectively in the initial position and in an intermediate position of the activation procedure.

[0083] In this embodiment, the movable connecting part (308) is in the form of a cylindrical body (370) guided in a complementary guide support (940) secured to the lower casing (107) of the housing to allow a sliding pivot type connection. For this section, the proximal parts of the cylindrical body (370) and the guide support (940) will be designated as the regions directly opposite the head of the reservoir (203), and the distal parts will be designated as the regions located on the opposite side, along a cylindrical axis of symmetry of the reservoir (203).

[0084] The cylindrical body (370) is provided with an annular section for producing an internal cylindrical cavity (371) opening at the distal end of the cylindrical body (370), this internal cylindrical cavity allowing a spring (350) to be received. The cylindrical body (370) is provided, at the proximal base of the annular section, with a leg (372) extending radially, said leg allowing, in the initial position, to produce axial abutment against a support (941) of the guide support (940). Said abutment is necessary to prevent the release of the mechanical energy stored in said spring (350) compressed in the initial state. At its distal end, the spring (350) bears against a laminar protrusion (950) of the lower casing of the housing, the forces being also able to be taken up by the upper casing of the housing.

[0085] The cylindrical body (370) has a dovetail shape (378) diametrically opposite said leg (372) and of the same axial extent, said dovetail (378) also being able to be put into axial abutment against a second support (942) of the guide support (940) to provide a second support for the spring (350) in the compressed state, radially symmetrical to the first stop provided by the leg (372). Of course, it is not strictly necessary for the two stops to be located in the same axial plane, nor even for two stops to be present, but this symmetrization promotes the resilience of the movable connecting part (308) to creep and also makes it possible to avoid the cylindrical body (370) being buttressed in the guide support (940).

[0086] Thus, in the initial position, only a rotational movement of the cylindrical body (370) is permitted in the guide support (940). This rotational movement can be achieved by cooperation of the leg (372) with an extractable part (360) inserted into an opening of the lower casing (107) of the housing, said extractable part (360) being able to be extracted from the medical device in a direction orthogonal to the base of the lower casing (107) of the housing. The extractable part (360) has a cylindrical base (361) extended axially by a protuberance provided with a light (362) into which a pin (373) is inserted, located at the radial end of the leg (372) and extending axially in the distal direction. The lumen (362) has a cam profile (363) for guiding a tangential movement of the radial end of the leg (372), during the extraction of the extractable part (360), causing the rotation of the cylindrical body (370).Note that the angular expansions of the dovetail (378) and the leg (372) are chosen so that both simultaneously leave their support zone (941, 942), during the rotational movement imparted by the extractable part (360). The angular position for which the dovetail (378) and the leg (372) simultaneously leave their support zone (941, 942) is called the intermediate position and is represented in.

[0087] The lower casing (107) of the housing is lined with an adhesive membrane (365) covered by a cover (364) having a removal tab (367), this assembly protecting against any contamination of the area of ​​the device affixed to the patient. The cover must be removed by the patient before use in order to be able to affix and maintain the device on the skin using the adhesive membrane (365). The cylindrical base (361) of the extractable part (360) has a portion emerging from the lower casing (107) of the housing which is fixed to the cover (364) of the adhesive membrane (365), so that when the patient removes the cover (364) of said adhesive membrane (365) the latter also causes the removal of the extractable part (360), thus setting the movable connecting part (308) in rotary motion.The mechanical connection between the cover (364) of my adhesive membrane (365) and the extractable part (360) can be achieved in multiple ways, and in particular by wedging the cover (364) by riveting in the extractable part (360) using a cap (366). In order to ensure a perfect seal, an O-ring (368) can be placed between the cylindrical base (361) and the opening of the lower casing (107).

[0088] The guide support (940) also has a longitudinal groove (945) extending from its proximal end to its distal end. This longitudinal groove (945) has a width greater than that of the leg (372) and the dovetail (378), so that when both have left their support zone (941, 942) by the rotational movement imparted by the extractable part (360), the cylindrical body (370) acquires an additional degree of freedom in translation in its axial direction. A translational movement of the cylindrical body (370) in the direction of the reservoir (203) is then impelled and constrained by the compressed spring (350), releasing its stored energy.

[0089] The cylindrical body (370) also has a radial protrusion (375) extending from the end of the dovetail (378) to the proximal end of said cylindrical body (370), holding the hollow needle (315) to allow it to expand in the proximal direction. The hollow needle (315) can, for example, be held in the movable connecting part (308) by an overmolding process, the adapter part being able to be produced by plastic injection, but this is not, however, limiting of the invention. Of course, this radial protrusion (375) also projects from the longitudinal groove (945) of the guide support (940) and has an angular expansion sufficiently limited so as not to hinder the rotational movement of the cylindrical body (370) imparted by the extractable part (360).

[0090] The translational movement of the cylindrical body (370) generated by the relaxation of the spring (350) requires the penetration of the hollow needle (315) into the reservoir (203) through its septum and therefore the fluidic connection of the reservoir (203) with the pump system (200). Note that in the initial position, the hollow needle (315) is not collinear with the axis of symmetry of the reservoir (203) and it is only following the completion of the first rotational movement to allow the relaxation of the spring that this alignment is obtained. The spring is judiciously chosen to be able to pierce the septum with sufficient dynamics and possibly another sterilization membrane (not shown).

[0091] Finally, the radial protrusion (375) of the cylindrical body (370) has at its distal end a tab (376) of angled shape, the end of this tab activating the switch (390) to power up the electronic system (310), the activation of said switch taking place at the end of axial movement of the cylindrical body (370) carried out by relaxation of the spring (350).

[0092] Thus, the movable connecting part (308) ensures the fluid connection of the reservoir (203) with the pump system (200) and the switching on of the transdermal drug injection device, in a single operation, this operation being induced by the intentional removal of the seal by the patient at the end of use of the medical device. This combination judiciously limits any risk of mishandling and eliminates any risk of contamination until its use.

[0093] As seen in the figure, the adhesive membrane (365) has a multiplicity of tabs (364) to facilitate its gripping and removal by the patient.

Claims

A transdermal drug delivery device comprising a housing, a battery (260), an injection system (100), a movable connecting piece (308) for ensuring fluidic connection between the injection system (100) and a reservoir (203) containing an active ingredient to be administered, a pump system (200) connected to the movable connecting piece (308) and to the injection system (100) by means of flexible tubing (231, 232, 233) to create a fluidic network, the pump system (200) being motorized to circulate a fluid within this network, an electronic system (310) for controlling the motorization of the pump system (200), said electronic system (310) being equipped with a mechanical switch (390) for powering it to said battery (260), characterized in that the movable connecting piece (308) has at least one degree of freedom relative to the housing on the one hand and the reservoir (203) on the other hand to allow movement,the movable connecting piece (308) jointly controlling the fluid supply to the pump (200) and the powering up of said electronic system during said movement, at least a part of said movement of the movable connecting piece (308) being carried out by human mechanical action, said movable connecting piece (308) comprising a fluid connection means between said reservoir and said pump on the one hand ensuring disconnection at rest and fluid communication during said movement, said movable connecting piece comprising a means for activating the power supply to the electrical and electronic components of said device ensuring disconnection at rest and power supply during said movement. Transdermal drug delivery device according to claim 1 characterized in that the movable connecting piece (308) is also intended to receive the reservoir (203) in the form of a removable bottle relative to the transdermal drug delivery device, the movable connecting piece (308) being moved along said at least one degree of freedom, upon receiving said reservoir (203). Transdermal drug delivery device according to the preceding claim characterized in that the connection of the reservoir (203) to the mobile linking piece (308) is made via an adapter piece (311), previously connected to the reservoir (203), the mobile linking piece (308) and the adapter piece (311) having complementary central tubes (320, 321) which fit together to make a leak-proof connection. Transdermal drug delivery device according to the preceding claim characterized in that the complementary central tubes (320, 321) achieve the leak-proof connection by conical fitting. Transdermal drug delivery device according to the preceding claim characterized in that the conical fitting made by the complementary central tubes (320, 321) is of the "luer" type. Transdermal drug delivery device according to the preceding claim characterized in that the movable connecting piece (308) has a cylindrical body (341) provided with a thread (330), the adapter piece (311) having a hollow cylindrical protrusion (340) in which the central tubing (321) expands, said hollow cylindrical protrusion (340) having on its internal surface a thread (331) cooperating with the thread (330) to ensure the tight connection of the central tubing (320, 321) by screwing an adapter piece (311) with the movable connecting piece (308), the tightness being guaranteed beyond a nominal tightening torque of the screwing. Transdermal drug delivery device according to the preceding claim characterized in that said degree of freedom of the movable link piece (308) for activating the switch (390) is a rotational degree of freedom achieved by guiding the movable link piece (308) in the lower housing (107) of the casing, the travel stroke of the movable link piece being angular, and in that the movable link piece (308) has a partial annular protrusion (384) extending axially from the cylindrical body (341) over a limited angular portion, said partial annular protrusion (384) being able, at the end of the stroke, to activate the switch (390) located in radial proximity to the movable link piece (308). Transdermal drug delivery device according to the preceding claim characterized in that the displacement stroke of the movable linking piece (308) is traversed by the rotational movement leading to the screwing of the adapter piece (311) with the movable linking piece (308). Transdermal drug delivery device according to any one of claims 2 to 8 characterized in that the travel stroke of the movable link piece (308), according to said at least one degree of freedom, has a notch at the end of the stroke to lock the movable link piece (308) in the final position, the notch requiring additional torque to be passed and reach the final position, the switch (390) being activated in the final position. Transdermal drug delivery device according to the preceding claim characterized in that the excess torque required to pass the notch, and reach the final position of movement of the mobile linking piece (308), is greater than the nominal tightening torque of the screwing of an adapter piece (311) with the mobile linking piece (308) allowing to guarantee the sealing of the fitting of the central tubes (320, 321). Transdermal drug delivery device according to the preceding claim characterized in that the movable connecting piece (308) has two cylindrical axial protrusions (381, 382) extending from the cylindrical body (341), these axial protrusions (381, 382) extending into the lower housing (107) of the casing and simultaneously abutting against ridges (912, 913) during the travel of the moving part of the movable connecting piece (308), the ridges (912, 913) being outgrowths of flexible beams (922, 923) integral with the lower housing (107), the abutment position of the axial protrusions (381, 382) against the ridges being able to be overcome by elastic deformation of the flexible beams (922, 923), being elastically deformable, to reach the final position of displacement of the movable connecting part (308), said notch being thus achieved by the elastic deformation of the flexible beams (922, 923). Transdermal drug delivery device according to the preceding claim characterized in that the screwing of the adapter piece (311) with the movable linking piece (308) is carried out by the user. Transdermal drug delivery device according to the preceding claim characterized in that the deformation and release of the flexible beams (922, 923), when the user applies excess torque to pass the notch, provides haptic information indicating the activation of the switch (390) and therefore of the device. Transdermal drug delivery device according to any one of claims 6 to 13 characterized in that the movable connecting piece (308) has a radial protrusion (383) and a partial annular protrusion (384), the final position of the movable connecting piece (308) being achieved by bringing said radial protrusion (383) and the partial annular protrusion (384) into contact respectively with complementary stops (915, 916) of the lower housing (107). Transdermal drug delivery device according to claim 1 characterized in that the movable connecting piece (308) is provided with a hollow needle (315) connected to a flexible tube (231), said hollow needle (315) being able to insert into the reservoir (203) during a translational movement of the movable connecting piece (308) to reach a final state. Transdermal drug delivery device according to the preceding claim characterized in that the translational movement is induced by a spring (350). Transdermal drug delivery device according to the preceding claim characterized in that in the initial state, the movable connecting piece does not have a degree of freedom in translation, but only a degree of freedom in translation, and in that the spring is in a compressed state. Transdermal drug delivery device according to the preceding claim characterized in that a first rotational movement of the mobile link piece (308) is carried out by a mechanical action of the patient to bring the mobile link piece (308) into an intermediate state for which it acquires the degree of freedom in translation allowing the insertion of the hollow needle (315) into the reservoir (203).

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