Transdermal drug delivery device

Abstract

The invention relates to a transdermal drug delivery device. The transdermal drug delivery device comprises a shell; a battery; an injection system; a movable connection portion for providing a 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 portion and the injection system by means of a flexible conduit in order to create a fluid network, the pump system being motorized in order to circulate fluid within the network; and an electronic system for controlling the driving of the pump system, the electronic system being provided with a mechanical switch for powering the pump system with the battery. The invention is characterized in that the movable connection portion has at least one degree of freedom with respect to the housing on one side and the reservoir on the other side so as to allow movement, the movable connection portion jointly controlling the fluid supply of the pump and the power supply of the electronic system during the movement, at least a portion of the movement of the movable connection portion is performed by a man-made mechanical action. The movable connection portion includes means for fluid connection between the reservoir and the pump, providing disconnection at rest, and providing fluid communication during the movement. The movable connection portion includes means for activating power supply of electrical and electronic components of the device, providing disconnection when at rest, and supplying power during the movement.

Description

Technical Field

[0001] The present invention relates to the field of external transdermal drug delivery systems combining pump systems and transdermal drug delivery systems. Typically, the system is integrated into a housing whose interior maintains the sterility of a fluid (a separate part) that adheres to the abdomen or chest or other area of ​​the patient and delivers the substance to the patient via a cannula inserted subcutaneously into the patient's body.

[0002] Medical treatment of several diseases requires continuous infusion of drugs via subcutaneous and intravenous injections, especially for drugs containing large molecules that cannot be digested when administered orally, such as insulin, biologic drugs or biosimilars.

[0003] Patients with chronic diseases of the immuno-oncology type or who require repeated postoperative treatments require bolus injections of drugs, which are usually administered by caregivers. The injection volume of these drugs can vary from a few milliliters to tens of milliliters. Since the flow rate is limited in order to make it tolerated by the patient, the injection time increases proportionally with the injection volume and directly affects the occupancy rate of the caregiver. Automatic drug injection pumps have been developed, which, on the one hand, can free up the time of caregivers when drug administration via the pump needs to be supervised by trained personnel, and on the other hand, due to the simplified automatic system, patients can safely self-administer drugs, giving them daily autonomy and significantly reducing the frequency with which they need to go to the hospital.

[0004] Basal and bolus volumes must be administered in precise doses according to individual prescriptions. Therefore, drug infusion pumps need to be highly reliable to ensure that patients and caregivers can accurately monitor the correct dose.

[0005] These pumps are also used to administer biologic drugs or active anticancer ingredients over shorter durations, from tens of minutes to hours, and less frequently, weekly or monthly.

[0006] To avoid the problem of re-sterilization of mobile devices for home treatment, disposable devices are preferred. Therefore, simplicity of the components of the device is crucial to ensure that the sales price is not too high.

[0007] Typically, the patient fills the reservoir with an active ingredient, such as from a vial, attaches a needle and dosing tube to the reservoir outlet orifice, and then inserts the reservoir into the pump housing. After purging air from the reservoir, tube, and needle, the patient inserts the needle assembly, puncture element, and cannula at a selected location on the body, and removes the puncture element. To avoid irritation and infection, the subcutaneous cannula must be replaced and discarded with the empty reservoir.

[0008] Alternatively, the patient or caregiver can use an additional transfer station to automatically transfer the contents of the vial to the internal reservoir of the medical device. To do this, the user usually needs to successfully connect the vial (and the vial adapter if not already integrated into the transfer station) to the transfer station on the one hand, and the medical device to the transfer station on the other hand, and then start the transfer sequence.

[0009] These devices are equipped with an internal energy source that provides power to the internal components when the drug is injected into the patient. Since these devices can be stored for long periods of time, it is critical to conserve power during this time and only power the system when needed.

[0010] Prior Art - Vial Connection

[0011] In the prior art, patent application US2013253427 is known to describe a drug dispensing device comprising a key verification part and a security part. The key verification part is configured to interact with a key part of another component of the drug dispensing device during assembly of the drug dispensing device. In order to support the use of the corresponding component, if the key part corresponds to the key verification part, the security part is configured to have a different impact than if the key part does not correspond to the key verification part.

[0012] Patent application US2020023123 describes a drug delivery system and its components. The system may include a pump device mounted on the body and a secondary unit. The pump device mounted on the body may include a reservoir and a fluid channel. The reservoir may be designed to contain a liquid drug. The secondary unit may be releasably connected to the pump device mounted on the body. The secondary unit may be designed to receive a prefilled cartridge containing a liquid drug, discharge the liquid drug from the prefilled cartridge, and distribute the liquid drug to the reservoir of the pump device mounted on the body via the fluid channel. In contrast to the present invention, this is a solution consisting of two assembled parts, namely a pump device 301 mounted on the body and a secondary unit 305, to form an injection device. In addition, a receiving part for moving the vial is never provided. The receiving part is formed by a fixed cavity. This solution is incompatible with fluid communication via the vial. It requires a special vial with a pierceable base. This solution also requires piercing the bottom with two needles; one for air intake to compensate for the transferred liquid volume.

[0013] Patent application US2020146938 describes a disposable fluid transfer and mixing device, which includes a syringe support surface for receiving an injection device thereon. Freeze-dried drug vials, diluent bottles, and syringes are also attached to the device. The device includes a fluid channel and a manual valve that can be manipulated so that the syringe can be used to transfer the diluent from the diluent vial to the freeze-dried drug vial for the reconstitution of the drug. The valve can also be designed to transfer the reconstituted drug from the freeze-dried drug vial to the injection device. The automatic transfer and mixing device receives the injection device, the freeze-dried drug vial, and the diluent vial, and transfers the diluent from the diluent vial to the freeze-dried drug vial, and shakes or vibrates the freeze-dried drug vial to reconstitute the drug.

[0014] Patent application US2020368447 describes a housing and an activation button assembly movably mounted on the housing and capable of moving from an unactuated position to an actuated position. The cartridge door is configured to receive a cartridge containing a substance to be dispensed therein and is movably mounted on the syringe housing between an open position and a closed position. A deflectable interference member is mounted in the syringe housing and blocks movement of the activation button assembly from its unactuated position to the actuated position in a static position. The activation button assembly is configured to activate the syringe when in the actuated position and can only move from the unactuated position to the actuated position when the interference member is deflected from its static position. When the cartridge door is in its closed position and the cartridge is arranged inside, the cartridge door deviates the interference member from its static position.

[0015] Disadvantages of Prior Art Vial Connections

[0016] Devices known in the prior art propose to power the device when removing the cover protecting the portion of the device applied to the patient and the sterility of this portion must be ensured until the last moment. This solution is satisfactory in its context, but is incompatible with devices with removable vials, which may require the filling of the internal reservoir before the injection. In fact, filling the internal reservoir is a slow operation, which is carried out by a pumping mechanism that requires an electric power supply. Based on this known technology, the patient will have to remove the cover to switch on the pumping system, immediately apply the device to the skin and wait for the completion of the pumping operation before the injection can be carried out. This means that the patient is subjected to unnecessary immobilization during an automatic operation, the presence of which is not necessary.

[0017] The removable vial devices known in the prior art do not offer a solution for preventing the inadvertent energization of the device by connecting it to a critical step that is not prone to handling errors. Although the devices of the prior art can satisfactorily ensure the internal reservoir filling step after the vial has been inserted, this is ensured by using a sensor that must be supplied with power. Therefore, in this scenario, the prior art does not propose to ensure the connection of the device to its energy source only during the unavoidable steps of the injection process that cannot be triggered inadvertently.

[0018] In particular, patent application US2013253427 describes a solution with a system for checking the consistency of a vial / device pair using an electromechanical coding system. This solution implies that the electronic circuit must first be switched on before the signals provided by these indexes can be used. As with other solutions in the prior art, there is a risk of untimely power consumption, with a consequent reduction in useful life and autonomy.

[0019] The solution provided by the present invention

[0020] In order to make up for the deficiencies of the prior art, the present invention in its most general sense relates to a transdermal drug delivery device having the technical features according to claim 1 .

[0021] The transdermal drug delivery device comprises:

[0022] a. Shell;

[0023] b.Battery;

[0024] c. Injection system;

[0025] d. a removable connecting portion for providing a fluid connection between the injection system and a reservoir containing an active ingredient intended to be administered;

[0026] e. a pump system connected to the movable connection part and the injection system by means of a flexible pipe so as to create a fluid network, the pump system being motorized so as to circulate the fluid within the network;

[0027] f. an electronic system for controlling the drive of the pump system, the electronic system being provided with a mechanical switch for powering the pump system using the battery,

[0028] the movable connection part has at least one degree of freedom relative to the housing on one side and to the reservoir on the other side so as 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 this movement,

[0029] - at least a part of the movement of the movable connection part is performed by human mechanical action,

[0030] the movable connection part comprises means for fluid connection between the reservoir and the pump, providing on the one hand a disconnection at rest and providing fluid communication during the movement,

[0031] - The movable connection part comprises means for activating the power supply of the electrical and electronic components of the device, providing disconnection when at rest and supplying power during the movement.

[0032] In a variant, the movable connecting part is also designed to receive the reservoir in the form of a vial removable from the transdermal drug delivery device, the movable connecting part moving in the at least one degree of freedom when receiving the reservoir.

[0033] Furthermore, the reservoir is connected to the removable connection part by means of an adapter part pre-connected to the reservoir, the removable connection part and the adapter part having complementary central conduits which fit together to form a sealed connection.

[0034] Additionally, a complementary center pipe may be used to create a sealed connection via a tapered fit.

[0035] In particular, the tapered fit created by the complementary central conduit may be of the "Luer" type.

[0036] In a variant, according to the at least one degree of freedom, the movement path of the movable connection part has a notch at the end of the stroke to lock the movable connection part in a final position, the notch requiring an additional torque to be transmitted and to reach the final position, wherein the switch is activated in the final position.

[0037] In particular, the additional torque required to pass through the recess and reach the final moved position of the movable connection part is greater than the nominal tightening torque for screwing the adapter part onto the movable connection part, thus ensuring the sealing of the central pipe connection.

[0038] In another variant, the movable connection part has a cylindrical body with tapping, wherein the adapter part has a hollow cylindrical protrusion, the center pipe extends into the hollow cylindrical protrusion, and the hollow cylindrical protrusion has a thread on its inner surface that engages with the tapping to ensure a sealed fit of the center pipe by screwing the adapter part to the movable connection part, and the sealing is guaranteed to exceed the nominal tightening torque.

[0039] Specifically, the degree of freedom of the movable connection part for activating the switch can be a rotational degree of freedom achieved by guiding the movable connection part in the lower shell of the housing, the movement path of the movable connection part is angular, and the movable connection part has a partial annular protrusion axially extending the cylindrical body over a limited angular portion, and the partial annular protrusion is capable of activating the switch located in the radial vicinity of the movable connection part at the end of the stroke.

[0040] In a variant, the movement path of the movable connection part is traversed by a rotational movement, the rotational movement causing the screwing of the adapter part with the movable connection part.

[0041] In one variant, the movable connecting part has two cylindrical axial protrusions extending from the cylindrical body, which extend into the lower shell of the housing and simultaneously abut against a flange during the course of the moving path of the movable connecting part, the flange being a protrusion of a flexible beam integral with the lower shell, the abutment position of the axial protrusion against the flange being able to be exceeded by the elastic deformation of the elastically deformable flexible beam to reach the final moving position of the movable connecting part, so that the recess is formed by the elastic deformation of the flexible beam.

[0042] In all variants, the adapter part can be screwed onto the removable connection part by the user.

[0043] Specifically, when the user applies excessive torque to pass the notch, the deformation and relaxation of the flexible beam provides tactile information that signals activation of the switch, and therefore activation of the device.

[0044] In another variant, the movable connection part has a radial projection and a part annular projection, the final position of the movable connection part being achieved by bringing the radial projection and the part annular projection into contact respectively with complementary stops on the lower shell of the housing.

[0045] In another variant of the injection device with a prefilled internal reservoir, the movable connecting part is equipped with a hollow needle connected to a flexible tubing, which hollow needle can be inserted into the reservoir during the translational movement of the movable connecting part to reach the final state.

[0046] Furthermore, the translational movement is caused by a spring.

[0047] More specifically, in the initial state, the movable connection part has no translational freedom and has only one translational freedom when the spring is in the compressed state.

[0048] More precisely, a first rotational movement of the movable connection part is performed by a mechanical action of the patient in order to bring the movable connection part into an intermediate state in which it acquires the translational degree of freedom allowing the hollow needle to be inserted into the reservoir.

[0049] DETAILED DESCRIPTION OF A NON-LIMITING EXEMPLARY EMBODIMENT

[0050] For a better understanding of the invention, and in order to show how embodiments of the invention may be implemented, reference will now be made by way of example to the accompanying drawings, in which:

[0051] 1. Figure 1 A top view showing the locking device of the insertion mechanism in its initial state,

[0052] 2. Figure 2 A top view showing the locking device of the insertion mechanism in its final state,

[0053] 3. Figure 3 The needle insertion mechanism is shown separately in perspective and partial cross-sectional views,

[0054] 4. Figure 4 shows a perspective view, partially in cross section, of a locking mechanism associated with the pump system and housed in the lower shell of the housing,

[0055] 5. Figure 5 showing a side view of the pump system associated with the locking mechanism,

[0056] 6. Figure 6 A perspective view showing the complete fluid system integrated in the lower housing of the enclosure,

[0057] 7. Figure 7 shows a side cross-sectional view of the pump,

[0058] 8. Figure 8 shows a top view of the pump body from which the valve plunger emerges,

[0059] 9. Fig. 9 shows a cross-sectional front view of the pump,

[0060] 10. Fig.10 Two pump hole shapes for connecting pipes and the fluid flow cross sections obtained for different valve plunger positions are shown,

[0061] 11. Fig.11 ,

[0062] 12. Fig.12 ,and

[0063] 13. Fig.13A perspective view of a fluid system compatible with an external reservoir showing different steps for reservoir insertion, wherein Fig.11 Shows all components before assembly. Fig.12 A reservoir positioned in the adapter portion is shown, and Fig.13 showing the reservoir and adapter portion assembly assembled with the removable connecting portion and in a final position,

[0064] 14. Fig.14 showing a cross-sectional side view of the adapter portion and the movable connection portion,

[0065] 15. Fig.15 shows a side view of the movable connecting part,

[0066] 16. Fig.16 ,and

[0067] 17. Fig.17 A top view of a movable connecting part integrated into the lower shell of the housing is shown in an initial position and a final position of an activation stroke, respectively,

[0068] 18. Fig.18 ,and

[0069] 19. Fig.19 A cross-sectional top view of a movable connecting part integrated into the lower shell of the housing is shown in an initial position and a final position of an activation stroke, respectively.

[0070] 20. Fig. 20 A cross-sectional top view of a variant of the movable connecting part integrated into the lower shell of the housing is shown in an initial position,

[0071] twenty one. Fig.21 shows a perspective view of a second variant of a pre-filled internal reservoir device,

[0072] twenty two. Fig. 22 shows a top view of a second variant with a prefilled internal reservoir in an initial state,

[0073] twenty three. Fig.23 shows a cross-sectional side view of a second variant with a prefilled internal reservoir in an initial state,

[0074] twenty four. Fig.24 shows a top view of a second variant with a prefilled inner reservoir in a final state,

[0075] 25. Fig.25 A cross-sectional side view of a second variation is shown with the pre-filled internal reservoir in an intermediate state.

[0076] Detailed description of the multifunctional operation of the insertion mechanism and the controlled release of the plunger rod

[0077] Figure 1 , Figure 2 , Figure 3 , Figure 4 and Figure 5 A first embodiment of a locking device for a needle insertion mechanism according to the present invention is shown, wherein Figure 1 Only the needle insertion mechanism is shown, as described in international patent application WO2018141697A1. Figure 2 and Figure 3 The needle locking and insertion mechanism is shown in top view, wherein Figure 2 shows the device in an initial state (referred to as "ready"), and Figure 3 The mechanism is shown after release and needle insertion. Figure 4 The needle locking and insertion mechanism is shown in perspective view, and Figure 5 The needle locking and insertion mechanism is shown in side view without the cam element.

[0078] Specifically, the injection system (100) includes a needle insertion mechanism composed of a cam element (101), and the needle insertion mechanism Figure 1 1 and 2. The cam element (101) is shown in more detail in a partial cross-sectional view. The cam element (101) has a rib (103) whose advantageous profile engages with the protrusions (111, 112) of the needle holder (120) and the cannula holder (122), so that the needle (121) and the flexible cannula (124) are inserted during a rotational movement of the cam element (101) of less than 360°, and then only the needle (120) is withdrawn. The cannula holder (124) has a catheter for receiving a conduit (130) carrying a fluid to be injected through the cannula (122), which is connected to the cannula (122) through an inner cavity (125). The insertion of the needle (120) and the cannula (122) is guided through a through hole (108) in the lower shell (107) of the housing. The rotational movement of the cam element (101) is caused by the helical spring (102) which is preloaded in the initial state. Figure 2 , Figure 3 , Figure 4 and Figure 5The locking system (110) described in detail in the present invention is held in place. The insertion sequence of the needle (120) is triggered by the release of the locking system (110), thereby allowing the cam element (101) to rotate freely and thus allowing the needle (120) to be inserted by means of the unloading of the spring (102). It should be noted that this movement sequence is irreversible and when it is completed, the spring (102) is in an unloaded state and opposes the movement of the cam (101) in a direction opposite to the direction used to insert the needle (120) and the cannula (122). Therefore, once the sequence has been completed, the needle (120) is retracted into the interior of the medical device and cannot be deployed again, thereby putting the device in a state that avoids any risk of harming the user. The use of a retractable needle (120) contained in a flexible cannula (122) does not limit the present invention and is particularly useful for ensuring the sterility of a fluid conduit as long as the needle is located in the cannula. Other alternatives for forming a fluid interface between the device and the patient can be easily conceived by those skilled in the art.

[0079] More specifically, the locking device comprises a translation element (104) and a rotation element (105), both of which are guided in respective translational and rotational movements by a lower shell (107) of the housing.

[0080] The translation element (104) has an arm (140) and a resilient protrusion (142), the distal end of the arm resting on the side surface (109) of the cam element (101) (at Figure 5 ) and its proximal end rests on the surface (150) of the rotating element (105), and the elastic protrusion ensures that the locking device (110) remains in its final position after release by engaging with the groove (172) of the lower shell (107) of the housing. The rotating element (105) has a surface (151) opposite to the surface (150), the opposite surface (151) resting on the protrusion of the lower shell (107) of the housing. Therefore, in the locked position, the engagement of the translation element (104) with the rotating element (105) enables the entire preload force of the helical spring (102) applied to the cam (101) to be directly transmitted to the lower shell (107) of the housing, thus preventing any possible movement. This also ensures a longer system service life during storage cycles, while avoiding the risk of partial creep using direct load transfer from the housing.

[0081] The locking device (110) can be released by moving the rotating element (105). The rotating element (105) has a body (152) with a lever arm (153) for guiding the body (152) in rotation around an axis (154). The rotation of the rotating element (105) causes the surface (150) and the opposing surface (151) to slide on opposing surfaces (141, 174) belonging to the translation element (104) and the lower shell (107) of the housing, respectively.

[0082] When the rotation of the rotating element (105) is sufficient to make the surface (150) no longer in contact with the surface (141) of the translating element (104), the locking mechanism (110) is released and the translating element (104) performs a translational movement induced by the preload force of the helical spring (102). During the translational movement of the translating element (104), the arcuate profile (143) of the elastic protrusion (142) slides along the grooves (171, 172) of the housing, causing the end of the elastic protrusion to move orthogonally to the translational movement of the translating element. When the vertex (144) of the arcuate profile (143) passes through the interval (175) between the two grooves (171, 172), the translation element (104) is no longer in contact with the cam (101), but thanks to the release of elastic energy accumulated by the elastic protrusion (142) as it moves along the first groove (171), it continues to translate along the groove (172), and finally reaches Figure 3 During the translational movement of the translational element (104), the lower surface (145) of the translational element (104) slides on the upper surface (155) of the rotational element (105) so as to force the rotational element (105) to move into abutment with the protrusion (173) on the lower shell (107) of the housing. The complementary profiles of the surfaces (145, 155) advantageously enable the translational element (104) to continue to move in translation after such abutment, while at the same time Figure 3 In the final position shown in , a rotational movement opposite to this abutment is prevented.

[0083] In this way, once the locking means have been released, the elastic projection ensures a safe final position in which the translation element ( 104 ) and the rotation element ( 105 ) are fixed, even in the event of sudden movements or shocks to the medical device.

[0084] Before the locking device is released, the translation element (104) and the rotation element (105) are held in place by the friction of the surface (150) and the opposing surface (151) on the surfaces (141, 174), respectively. The rotation of the rotation element (105) and the resulting release of the locking device are achieved by pressing the end of the pump plunger (205) against the circular surface (156) of the lever arm (153). In the embodiment shown, the pressure is achieved on the end portion of the movement path of the pump plunger (205), thereby advantageously enabling the pumping function to be performed before the locking device is released, so that, for example, the fluid to be injected can be transferred from the external reservoir to the internal reservoir before the device is placed on the patient. During this operation, the stroke of the pump plunger can be easily limited by software.

[0085] Of course, once the locking device (110) has been triggered by the first movement of the pump plunger (205) at the extreme part of its stroke, the pump plunger (205) can benefit from the full stroke for the pumping function and thereby increase the amount transferred from the internal reservoir into the patient's body with each pump cycle.

[0086] Note that the pump plunger (205) only ensures the rotational movement of the rotating element (105) until the locking mechanism (110) is released, as described above. In order to ensure the free movement of the plunger on this end stroke, after releasing the locking means (110), it is necessary to keep the rotating element (105) in the safe position allowed here by its engagement with the translating element (104).

[0087] Detailed description of the pump body with rectangular holes

[0088] One embodiment of the pump system (200) is Figures 6 to 10 Shown in. Figure 6 A pump system (200) is shown integrated into the lower housing (107), connected to a reservoir (203) for the fluid to be pumped out and to an internal reservoir (215). Figure 7 A cross-sectional side view of a pump system (200) is shown revealing a fluid circuit. Figure 8 A side view of the pump body (201) is shown, from which the valve plunger (202) emerges. Fig. 9 A radial cross-section of a pump system (200) is shown, wherein the pump body (201) is cut in two axially offset planes to simultaneously reveal ports (212 and 213). Fig.10 a to Fig.10 d highlights the geometry of the three ports (21, 212, 213) of the pump body (201) and their advantages over those used in international patent application WO2018141697A1.

[0089] More specifically, and as Figure 6 and Figure 7 As shown in the figure, the pump consists of a pump body (201) and two plungers (pump plunger (205) and valve plunger (202)), defining a variable volume inner chamber (208) between them. The two plungers are respectively connected to racks (248, 258), which can be set to axial movement by a drive system (240, 250), the drive system including a mechanical movement reducer (241, 251), the input end of which is connected to an electric motor (242, 252). The fluid transfer in the inner chamber (208) is made possible by the engagement of multiple ports (211, 212, 213) with the internal channel (209) of the valve plunger (202), which opens to the inner chamber (208) at one end and is terminated by an orifice (221) at its other end. Precise axial positioning of the valve plunger (202) enables selective engagement of one of the ports (211, 212, 213) with the pump orifice (221).

[0090] exist Figure 6 In the example shown in , port (211) is connected to a reservoir (203) (e.g., a vial) of the fluid to be withdrawn, port (212) is an outlet port and is connected to the injection system, and port (213) is connected to an internal reservoir (215) of the medical device. Ports (211) and (213) may alternatively be used as input ports or output ports. A pump outlet port is understood to be a port from which fluid only flows out in order to leave the inner cavity (208) of the pump. In an initial state, the valve plunger (202) and the pump plunger (205) are in face-to-face contact or only slightly separated, so that the inner cavity (208) has a low amount of air.

[0091] Two injection sequences are preferred, but not limiting to the invention: using an internal reservoir or by direct injection.

[0092] 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 broken down into the following steps:

[0093] • synchronously moving the valve plunger (202) and the pump plunger (205) via their respective drive systems (240, 250) to align the pump orifice (221) with the port (211) connected to the reservoir (215),

[0094] ● Moving the pump plunger (205) alone by means of the drive system (250) so as to increase the volume of the internal cavity (208) between the valve plunger (202) and the pump plunger (205), thereby generating a negative pressure which causes liquid to flow from the reservoir (203) through the internal channel (209)

[0095] is drawn into the inner cavity (208),

[0096] • Once the lumen is completely filled, synchronously moving the plungers (202, 205) using their respective drive systems (240, 250) so as to align the pump orifice (221) with the port (213) connected to the internal reservoir (215),

[0097] the pump plunger (205) is moved solely in translation by its drive system (250) so as to reduce the volume of the internal cavity (208) and thereby expel all the fluid contained in the internal cavity (208) through the internal channel (209) and towards the internal reservoir (215),

[0098] ● Once the liquid is drained, the above steps are repeated continuously until the liquid is contained in the reservoir.

[0099] All of the liquid in (203) or a predetermined amount is transferred to an internal reservoir (215).

[0100] Once the fluid has been completely transferred into the internal reservoir (215), injection into the patient can begin. Therefore, the first step is to trigger the needle insertion system, as described, for example, in international patent application WO2018141697A1. Once the cannula has been inserted into the subcutaneous tissue, a new pumping sequence occurs according to the following steps:

[0101] • synchronously moving the valve plunger (202) and the pump plunger (205) via their respective drive systems (240, 250) to mate the pump orifice (221) with the port (213) connected to the internal reservoir (215),

[0102] moving the pump plunger (205) alone by means of the drive system (250) so as to increase the volume of the inner cavity (208) between the valve plunger (202) and the pump plunger (205), thereby generating a negative pressure which causes liquid to be drawn from the internal reservoir (215) through the internal channel (209) into the inner cavity (208),

[0103] • Once the lumen is completely filled, synchronously move the plungers (202, 205) using their respective drive systems (240, 250) so as to align the pump orifice (221) with the port (212) connected to the injection system,

[0104] solely translating the pump plunger (205) through its drive system (250) so as to reduce the volume of the lumen (208), thereby expelling all the fluid contained in the lumen (208) through the internal channel (209) and towards the injection system,

[0105] • Once the liquid has been completely drained, the aforementioned steps are continuously repeated until all the liquid contained in the internal reservoir (215) or a predetermined amount has been transferred into the patient.

[0106] The second injection sequence eliminates the need to transfer fluid to an internal reservoir. Therefore, the first step is to trigger the needle insertion system, as described, for example, in international patent application WO2018141697A1. Once the cannula has been inserted into the subcutaneous tissue, the pumping sequence occurs according to the following steps:

[0107] • synchronously moving the valve plunger (202) and the pump plunger (205) via their respective drive systems (240, 250) to align the pump orifice (221) with the port (211) connected to the reservoir (203),

[0108] ● Moving the pump plunger (205) alone by means of the drive system (250) so as to increase the volume of the internal cavity (208) between the valve plunger (202) and the pump plunger (205), thereby generating a negative pressure which causes liquid to flow from the reservoir (203) through the internal channel (209)

[0109] is drawn into the inner cavity (208),

[0110] • Once the lumen is completely filled, synchronously move the plungers (202, 205) using their respective drive systems (240, 250) so as to align the pump orifice (221) with the port (212) connected to the injection system,

[0111] solely translating the pump plunger (205) through its drive system (250) so as to reduce the volume of the lumen (208), thereby expelling all the fluid contained in the lumen (208) through the internal channel (209) and towards the injection system,

[0112] • Once the liquid has been completely drained, the aforementioned steps are continuously repeated until all the liquid contained in the reservoir (203) or a predetermined amount is transferred into the patient.

[0113] These two injection sequences do not limit the present invention, and other alternatives can be envisioned. Specifically, the pump system (200) can be used for drug reconstitution functions, such as for reconstructing lyophilized drugs and diluents. Then, the internal reservoir (215) can be a cartridge pre-filled with a diluent, and a pump sequence can be performed to transfer the diluent to the reservoir (203) containing the lyophilized drug in order to dissolve it. Once the lyophilized drug has dissolved, a reverse transfer from the reservoir (203) to the internal reservoir (215) is performed for subsequent injection into the patient. It is also conceivable to perform several continuous (partial or complete) transfers between the reservoir (203) and the internal reservoir, as this can cause the lyophilized drug to dissolve in the diluent.

[0114] Alternatively, the external reservoir (203) may be omitted entirely and the internal reservoir (215) may be a cartridge pre-filled with the fluid to be injected. In this case, the fluid is transferred from the internal reservoir (215) to the lumen and then to the injection system. This sequence of steps is repeated as many times as desired.

[0115] As in Figure 8 As can be seen more specifically in the figure, the ports (211, 212, 213) are staggered, the ports (211 and 213) are located in the same longitudinal plane, the port (212) is radially offset and axially located between the two ports (211 and 213). This staggered configuration is particularly advantageous for limiting the stroke required for the valve plunger (202) to select one of the ports (211, 212, 213), as this process must be repeated several times during an injection cycle. The axial proximity of the ports (211, 212, 213) has a direct impact on the durability of the battery (260) and therefore on the overall performance of the device. Disadvantageously, the axial size of the ports is limited and therefore the axial positioning of the valve plunger (202) must be more precise, as incorrect positioning results in a reduced fluid flow cross section. Depending on the viscosity of the fluid, this may result in a significant pressure loss and therefore a reduction in fluid flow.

[0116] According to this principle, it is assumed that the orifice of the valve plunger of the pump is positioned opposite one of these ports, which is a key point in the current prior art, as embodied in the international patent application WO2018141697A1. Ensuring a minimum fluid flow cross section in the event of an axial "mispositioning" of the plunger has the following advantages: making the system more stable and robust, and limiting pressure losses, thus ensuring an accurate flow rate, amount of drug injected into the patient's body and injection time. The present invention proposes to overcome this problem by suggesting two improvements, which can be used independently or in combination.

[0117] Figure 8 and Fig. 9One of these improvements is highlighted. 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 plunger (202). Therefore, in order not to reduce the pump flow, the orifice (211) of the valve plunger (202) has tangential flares (223, 224) on either side of its radial end facing the ports (211, 212, 213). These flares are defined by tangential flanges (225, 226) and axial flanges (227, 228) to match the cylindrical inner surface of the pump body (201) and ensure sealing, and the tangential flanges and axial flanges are made of a flexible, deformable material (such as silicone or a soft thermoplastic material). To this end, the valve plunger has a hard core (230) in which an internal conduit (209) connected to an orifice (221) is formed, the hard core (230) being overmolded by an elastomer (229) to form tangential flares (223, 224). Fig. 9 A radial cross section of a valve body is shown, wherein the left and right valve halves of the valve are not in the same axial plane, but in two half planes, respectively, in the middle of port (212) and in the middle of port (213). The cross section shows the correct alignment between the tangential flares (223, 224) and the ports (212, 213) that are tangentially offset from the orifice (221) of the valve plunger (202).

[0118] The second improvement in valve plunger position tolerance is Figure 7 , Figure 8 and Fig.10 Specifically, the ports (211, 212, 213) of the pump body (205) extend through the conical recesses (231, 232, 233) for contacting Figure 4 The cylindrical flexible pipe (261, 262, 263) shown in the figure is connected to the connecting element of the fluid system, while providing radial stops for these pipes by means of shoulders (220, 222). Therefore, the diameter of the port (211, 212, 213) must be smaller than the outer diameter of the flexible pipe and ideally larger than the inner diameter of the flexible pipe so as not to restrict the flow. Although the shoulder fixes the mechanical assembly, it does not have to exist around the entire circular periphery of the flexible pipe. Therefore, the port (211, 212, 213) can advantageously have a rectangular periphery to increase the cross-section relative to the valve plunger orifice (202) while providing a mechanical stop for the flexible pipe.

[0119] like Figure 8 As shown in FIG. 1 , the rectangular perimeter is understood to mean that the cross-section of the ports ( 211 , 212 , 213 ) is not disc-shaped, but has different lengths in the axial and tangential directions. Figure 8 In the example shown in Fig.10In sub-figures c and d, the cross-section is a groove in the tangential direction, terminating in two semi-cylinders. However, the present invention is not limited to this type of shape, but includes any type of elongated cross-section, such as rectangular or elliptical. In addition, the longer length is not limited to the tangential direction, but can also be achieved in the radial direction and will be selected according to the arrangement of the ports (211, 212, 213).

[0120] Fig.10 Different positioning scenarios for the valve plunger (202) are shown, with sub-figures a and b representing the case where both the orifice (221) and the port (211) have a disc-shaped cross section, as implemented in patent application WO2018141697A1. Sub-figure a shows a 0.5 mm diameter with a 0.196 mm 2 The cylindrical port (211) of the cross section is perfectly aligned with the same orifice (221), and the fluid flow cross section is represented by cross-hatching. Sub-figure b shows the evolution of the shaded cross-sectional area when there is an axial misalignment between the orifice (221) and the port (211), and it can be seen that: a deviation of 0.1 mm produces a flow of 0.122 mm 2 The remaining cross-sectional area, i.e., is reduced by more than 35%. The rectangular shape of the port (211) according to the present invention is shown in sub-figures c and d, and when combined with the same orifice or a disc-shaped orifice with tangential flaring as shown, provides 0.321 mm in the same axial space. 2 The cross-sectional area of ​​the fluid is shown in Figure d. The evolution of the shaded cross-sectional area in the case of incorrect axial positioning of the pump. Note that for a 0.1 mm offset, the cross-sectional area is reduced to leave 0.268 mm 2 Also note that until the axial offset reaches 0.2 mm, that is, the cross-sectional area is 0.198 mm 2 , this flow cross section is still greater than or equal to the flow cross section obtained for a disc-shaped cross-section port of the same axial size. This means that even with a 0.2 mm offset, corresponding to the extreme tolerance, the shape of the present invention ensures that the fluid flow cross section is equivalent to The cylindrical shape of the pipe, as implemented in the prior art. The shape of the invention thus enables precise positioning of ± 0.2 mm without affecting the pressure losses in the system.

[0121] It should be noted that the invention is not limited to a rectangular shape but can be extended to any shape that increases the cross section of the fluid flow while ensuring radial stop of the pipe connected to the pump body.

[0122] Detailed description of activation by reservoir insertion

[0123] exist Figures 11 to 20The medical device according to one variant of the invention under consideration is capable of docking with an external reservoir (203) such as a vial. In order to simplify the use of the device and its reliability, the vial must be coupled with an adapter portion (311) designed to fit into the removable connection portion (308) of the medical device, having a complementary shape. Figure 5 In the example shown in , the adapter part (311) has a hollow needle (315) designed to pierce the septum of the reservoir (2203) or vial and extract the fluid contained therein, the hollow needle (315) being connected to the central channel of the adapter part (311). This operation is performed before the medical device is activated, and the configuration of the septum and the needle makes it possible for only the fluid to flow through the internal channel, thus preventing air from entering the reservoir (203) and thus preventing the fluid contained in the reservoir (203) from flowing spontaneously. The activation of the medical device is achieved by inserting the adapter part (311) into the removable connecting part (308). To this end, the adapter part (311) and the removable connecting part (308) can be screwed into each other so that the complementary central conduits (320, 321) on the two parts engage to provide a sealed flow channel for conveying fluid between the vial and the medical device. In the example shown, the central conduit (320, 321) is engaged by means of a tapered fitting to form a Luer-type connection, but the present invention extends to any type of connection compatible with medical applications. When the adapter portion (311) is screwed into the removable connection portion (308), the torque applied by the adapter portion (311) on the removable connection portion (308) drives the latter to rotate so as to activate the electronic system (310) and permit the transfer of the drug to the internal reservoir, as described in international patent application WO2018141697A1. Once the drug has been transferred, the user can disconnect it by unscrewing the adapter portion (311), which then returns the removable connection portion (308) to its initial position and simultaneously deactivates the electronic system (310). During the sequence of activating and deactivating the system by the described components, the user can be notified of the status of the medical device by a tactile or visual signal (such as vibration or power supply of an LED). The triggering of the signal can be directly activated by the user's action on the device.

[0124] Figures 11 to 13 An isolation fluid system (300) according to one embodiment of the present invention is shown. Fig.11 and Fig.13 is a perspective view showing the various steps involved in connecting an external reservoir (203), wherein Fig.11 An exploded view of each unconnected element is shown, Fig.12 The reservoir (203) is shown connected to the adapter portion (311), and Fig.13The reservoir (203) and adapter portion (311) assembly are shown connected to the removable connecting portion (308). The various figures also show other components of the fluid system, namely, the fluid portion of the pump system (200), the internal reservoir (215) and the needle holder (121) of the injection system, these various elements being connected by a flexible conduit, one end of which is inserted into a recess (231, 233) in the pump body (201). The fluid is directed to either element by means of the movement of the valve plunger (202) and the pump plunger (205) described in the present application. Specifically, Fig.11 The presence of a hollow needle (315) is shown, which is designed to pierce the septum of the external reservoir to form a sealed connection between the external reservoir (203) and the fluid system line (300). Fig.12 , obtained by screwing the adapter part (311) and the movable connecting part (308) together by engaging the threads (331) and the tapping (330) Fig.13 Components shown in .

[0125] Fig.14 A cross-sectional view of the adapter portion (311) and the removable connection portion (308) before assembly is shown to better see the fluid connection between these parts and their connection. Specifically, complementary central conduits (320, 321) belonging to the adapter portion (311) and the removable connection portion (308), respectively, provide a fluid connection between the fluid outlet port (313) of the adapter portion (311) and the inlet port (387) of the removable connection portion (308). The hollow needle (315) of the adapter portion (311) has an internal channel terminating at the outlet port (313), which leads to the central conduit (320). The removable connection portion (308) is formed by a cylindrical body (341) having an axially open cavity, into which the central conduit (321) extends, and the inner cylindrical surface of the cavity has a tapping (330) that engages with the thread (331) of the adapter portion (311). At its other axial end, the movable connection part (308) has a hollow axial projection (386) with a slightly tapered periphery, which allows it to be easily inserted into a flexible pipe to ensure that the fluid is transferred to the pump body. The movable connection part is thus axially traversed by the conduit opening on the one hand, to an inlet port (387) at one axial end of the central pipe (321), and on the other hand to an outlet port (388) located at the end of the axial projection (386).

[0126] The central conduits (320, 321) are advantageously of conical shape, known as "Luer taper", which, when sufficient contact force is ensured, allows a sealed connection according to ISO 80369. The interlocking of the complementary central conduits (320, 321) and the application of the force required for sealing are provided by means of the engagement of a thread (331) complementary to a tapping (330), which is formed in a hollow cylindrical protrusion (340) of the adapter part (311) and in a cylindrical body (341) of the removable connection part (308), respectively, around the central conduits (320, 321). Thus, once the adapter part (311) and the removable connection part (308) are assembled, any fluid entering through the hollow needle (315) is fed to the outlet port (388) without any possible leakage. The removable connection part (308) ensures and secures the supply of fluid from the pump system (200) to the reservoir (203) containing the drug.

[0127] It should be noted that this arrangement of connection does not limit the invention, since a person skilled in the art could easily conceive of alternative solutions of connecting the two complementary parts of the pipe in a sealed manner by means of a screwing method.

[0128] Fig.15 Given Figures 11 to 14A more detailed view of the movable connection part (308) shown in FIG. In the upper part of the figure, the central duct (321) emerging from the hollow cylindrical body (341) is visible, which is characterized by tapping for screwing onto the adapter part (311). Also shown is the cylindrical body (341) for guiding the rotation of the movable connection part (308) by engaging with the annular protrusion of the lower shell (107) of the housing. Finally, in order to ensure that the rotation stops once the adapter part (311) is completely screwed into the movable connection part (308) by the user, two cylindrical axial protrusions (381, 382) are opened from the cylindrical body (341), these axial protrusions (381, 382) are radially positioned on either side of the axial protrusion (386) and are designed to extend into the lower shell (107) of the housing so as to engage with the elastically deformable part, thereby ensuring that the final angular position of the movable connection part is maintained. This final angular position is obtained by a radial protrusion (383) radially opening from the lower axial end of the cylindrical body (341) abutting against a complementary abutment of the lower shell of the housing. Finally, it can be noted the presence of a partial annular protrusion (384) which extends the cylindrical body (341) axially over a limited angular portion. This partial annular protrusion (384) is called an activation arm and enables the medical device activation switch to be engaged or released depending on the angular position of the movable connection part (308). The partial annular protrusion (384) also has a cylindrical inner surface concentric with the cylindrical protrusion of the lower shell of the housing to ensure that the movable connection part (308) is again rotatably guided.

[0129] Fig.16 and Fig.18 The movable connection part (308) mounted in the lower shell (9) of the housing is shown in its initial state, ie before insertion of the reservoir fitted with its adapter part. Fig.16 shows a view from an axial perspective, and Fig.18A cross-sectional view at the level of the axial projections (381, 382) from the same angle is shown. During tightening, the adapter part (311) is axially inserted into the movable connection part (308), wherein the movable connection part remains stationary until the central pipe is coaxially in contact for wedging. Therefore, if an additional torque is applied to the adapter part (311), the torque is transmitted to the movable connection part (308), the rotation of which is stopped by the axial projections (381, 382) against the flanges (912, 913) of the lower shell (107) of the housing. The flange (912, 913) is a protrusion located in the flexible beam (922, 923) which can be elastically deformed by the axial protrusion (381, 382) when a threshold torque is applied, allowing the movable connection part to rotate until the radial protrusion (383) and the part of the annular protrusion (384) abut against the complementary stop (915, 916) of the lower shell (107) of the housing. The final position is Fig.17 and Fig.19 As shown in the figure, they correspond to Fig.16 and Fig.18 It may be noted that, as an alternative or in addition to the flexible beams (922, 923), the axial protrusions (381, 382) may be deformed so as to allow the movable connection portion (308) to rotate when a torque greater than a threshold torque is applied to the latter.

[0130] When the movable connecting part (308) rotates, the partly annular protrusion (384) presses against the lever of the activation switch (390) of the medical device arranged on the electronic system (310). At the end of the movement, when they come into contact with the complementary stops (915, 916) respectively, the radial protrusion (383) and the partly annular protrusion (384) absorb any excess torque supplied by the user to the movable connecting part (308), preventing this excess torque from affecting the axial protrusions (381, 382), thereby avoiding damage to them.

[0131] It should be noted that the deformation torque required to rotate the movable connection part (308) is greater than the minimum torque required to ensure the sealing of the connection according to ISO 80369. This deformation acts as tactile feedback to the user to indicate successful reservoir (203) installation and activation of the medical device.

[0132] It should also be noted that the final angular position is not irreversible. If the user applies a torque in the opposite direction with the same torque amplitude as that deployed to activate the device, the axial protrusions (381, 382) can again elastically deform the flexible beams (922, 923), thereby rotating the movable connection back to the original position. Fig.16 and Fig.18The initial state shown in . This operation is accompanied by the release of the switch (390), thereby indicating to the medical device that the vial is no longer engaged. The user can continue to unscrew the adapter portion (311) to remove the reservoir (203).

[0133] The activation system thus provides a function that guarantees a monitored user and safe insertion of the vial, thus limiting any risk of misuse. In fact, since the fluid connection of the pump system (200) with the reservoir (203) and the power supply of the electronic system (310) supplying the pump system (200) are both performed by the same removable connection part (308), it is impossible for the device to initiate a pumping and injection sequence without the cartridge being correctly inserted during the same operation, just as it is equally impossible to make fluid contact and trigger an injection after a long period of time (for example several days), thus eliminating any risk of erroneous operation or contamination.

[0134] Fig. 20 A variation of the flex beam (922, 923) is shown which no longer has a central flange, but instead has an arcuate shape terminating in free ends (932, 933). Fig. 20A cross-sectional view of the removable connection part (308) mounted at the level of the axial protrusions (381, 382) and in its initial state (i.e., before the reservoir (203) equipped with its adapter part (311) is inserted) is shown. In this initial position, the axial protrusions (381, 382) abut the free ends (932, 933) respectively. When the vial is screwed in, the rotation of the removable connection part (308) is achieved by elastic deformation of the flexible beams (922, 923) (by centrifugal displacement of their free ends (932, 933)). Once sufficient deformation has been applied, the axial protrusions (381, 382) can be accommodated at the base (942, 943) of the flexible beams, resulting in a release of the elastic stress and the free ends (932, 933) returning to their initial position. This configuration provides a hard point during the insertion of the vial so as to provide tactile feedback to the user once the elastic release of the flexible beams (922, 923) is completed. This configuration is advantageous compared to previous methods because it allows an asymmetry between the effort required to screw in the vial and the effort required to unscrew it. In fact, the elastic deformation of the beam is much easier when performed from the base of the beam towards its end than vice versa. By appropriately selecting the curvature of the flexible beam (922, 923) and the profile of the surface of the free end (932, 933) in contact with the axial protrusion, a screwing torque that is very different from the unscrewing torque, for example more than twice as high, can be obtained. This is particularly useful for ensuring that the unscrewing sequence of the reservoir (203) is fully completed. In fact, the screwing torque required to overcome the hard point formed by the flexible beam is very close to the torque required to tighten the adapter part (311) in the movable connection part (308). The unscrewing torque through the hard point of the same size can cause the adapter part (311) to be unscrewed from the movable connection part (308) before passing the hard point generated by the flexible beam, thereby leaving the movable connection part (308) in the final state and thus activating the device when removing the reservoir.

[0135] Activate by removing the protective cover

[0136] exist Figure 21 to Figure 25In a specific embodiment shown in , the transdermal drug delivery device is equipped with an internal reservoir (203), which is pre-filled with the medicine to be injected separately in advance. In fact, the previously proposed embodiment and equipped with an external reservoir involves the operation of filling the internal reservoir that requires a pump system. This operation may be slow and time-consuming for medical personnel, but it may also be affected by processing errors. Therefore, an alternative is to save these steps, so as to provide patients with a device that already contains appropriate drugs and minimizes the number of required operations. The device is pre-loaded by a qualified person and remains sterile until it is used by the patient. In order to limit the risk of contamination, the drug is stored in a sealed internal vial until the hollow needle (315) penetrates the septum of the reservoir.

[0137] As in the previous embodiment, the hollow needle (315) is connected to the pump system (200) via a flexible tubing (231), which in turn is connected to the injection system (100) (not shown). This embodiment also features a removable connection portion (308) for fluidly connecting the pump system (200) to the reservoir (203) and for powering the electronic system (310) that supplies the pump system (200).

[0138] However, this method is Figures 6 to 20 The embodiment shown in FIG. 1 differs in that the reservoir ( 203 ) does not have an adapter portion ( 311 ) and the hollow needle ( 315 ) is directly supported by the movable connecting portion ( 308 ). Figure 22 to Figure 25 As shown more specifically in FIG. 1 , the movable connecting part ( 308 ) has a complex movement that is decomposed into a first rotational movement performed by a mechanical action of the user, followed by a translational movement performed by the relaxation of a spring ( 350 ) preloaded during storage of the device. Fig. 22 and Fig.24 The injection device is shown, viewed from above and with the cover opened, in the initial and final position of the activation process, respectively. Fig.23 and Fig.25 The injection device is shown seen from the side in an initial position and an intermediate position of the activation process, respectively, with the injection device perpendicular to the hollow needle (315) and the cover open.

[0139] In this embodiment, the movable connection part (308) is in the form of a cylindrical body (370) which is guided in a complementary guide support (940) integral with the lower shell (107) of the housing to enable a sliding pivot type connection. For the purposes of this section, the area of ​​the cylindrical body (370) and the guide support (940) directly opposite the head of the reservoir (203) will be referred to as the proximal part, and the area on the opposite side along the cylindrical symmetry axis of the reservoir (203) will be referred to as the distal part.

[0140] The cylindrical body (370) is provided with an annular section to form an inner cylindrical cavity (371) opened at the distal end of the cylindrical body (370), which accommodates the spring (350). The cylindrical body (370) is equipped with a radially extending leg (372) at the proximal base of the annular section, which leg in the initial position makes an axial abutment against the support (941) of the guide support (940). This abutment is necessary to prevent the release of the mechanical energy stored in the spring (350) compressed in the initial state. At its distal end, the spring (350) abuts against the lamellar protrusion (950) of the lower shell of the housing, while the force can also be absorbed by the upper shell of the housing.

[0141] The cylindrical body (370) has the shape of a dovetail (378) diametrically opposite to the leg (372) and having the same axial extent, which dovetail (378) is also able to abut axially against the second support (942) of the guide support (940) to achieve a second retention of the spring (350) in a compressed state, which is radially symmetrical to the first abutment achieved by the leg (372). Of course, it is not strictly necessary that the two stops are located in the same axial plane, or even that there are two stops, but this symmetry promotes the creep elasticity of the movable connection part (308) and also prevents the cylindrical body (370) from bending in the guide support (940).

[0142] Thus, in the initial position, only the rotational movement of the cylindrical body (370) in the guide support (940) is allowed. This rotational movement can be achieved by the engagement of the leg (372) with the extractable part (360) inserted into the opening in the lower shell (107) of the housing, and the extractable part (360) can be extracted from the medical device in a direction orthogonal to the base of the lower shell (107) of the housing. The extractable part (360) has a cylindrical base (361) that is axially extended by a protrusion provided with a narrow groove (362), and a pin (373) located at the radial end of the leg (372) and extending axially in the distal direction is inserted into the narrow groove. The groove (362) has a cam profile (363) to guide the tangential movement of the radial end of the leg (372) when the extractable part (360) is extracted, thereby causing the cylindrical body (370) to rotate. Note that the angular spread of the dovetail (378) and the leg (372) is selected so that both leave their support areas (941, 942) simultaneously during the rotational movement imparted by the extractable portion (360). The angular position in which the dovetail (378) and the leg (372) leave their support areas (941, 942) simultaneously is referred to as the intermediate position and is Fig.25 Shown in.

[0143] The lower shell (107) of the housing is lined with an adhesive film (365) covered by a cover (364) featuring a removal tab (367), which protects the area of ​​the device fixed to the patient from any contamination. The cover must be removed by the patient before use so that the device can be applied to the skin and held in place by the adhesive film (365). The cylindrical base (361) of the extractable part (360) has a portion exposed from the lower shell (107) of the housing, which is attached to the cover (364) of the adhesive film (365) so that when the patient removes the cover (364) from the adhesive film (365), the latter also causes the extractable part (360) to be removed, thus setting the movable connecting part (308) to a rotational movement. The mechanical connection between the cover (364) of the adhesive membrane (365) and the extractable part (360) can be achieved in various ways, in particular by wedging the cover (364) using a cap (366) riveted into the extractable part (360). To ensure a perfect seal, an O-ring (368) can be fitted between the cylindrical base (361) and the opening in the lower housing (107).

[0144] The guide support (940) also has a longitudinal groove (945) extending from its proximal end to its distal end. This longitudinal groove (945) is wider than the leg (372) and the dovetail (378), so that when both leave their support areas (941, 942) due to the rotational movement imparted by the extractable part (360), the cylindrical body (370) obtains an additional degree of translational freedom in its axial direction. The translational movement of the cylindrical body (370) towards the reservoir (203) is then pushed and constrained by the compression spring (350), thereby releasing its stored energy.

[0145] The cylindrical body (370) also has a radial projection (375) extending upward from the end of the dovetail (378) to the proximal end of the cylindrical body (370), holding the hollow needle (315) so that it is opened in the proximal end direction. The hollow needle (315) can be retained in the movable connecting part (308), for example, by an overmolding process, and the adapter part can be made of injection molded plastic, but this is not a limiting factor of the present invention. Of course, the radial projection (375) also protrudes from the longitudinal groove (945) of the guide support (940) and has a sufficiently limited angular extension so as not to hinder the rotational movement of the cylindrical body (370) imparted by the extractable part (360).

[0146] The translational movement of the cylindrical body (370) produced by the relaxation of the spring (350) forces the hollow needle (315) to penetrate the septum of the reservoir (203) and thus fluidly connect the reservoir (203) with the pump system (200). Note that in the initial position, the hollow needle (315) is not co-linear with the axis of symmetry of the reservoir (203), and this alignment is only achieved after the first rotational movement is completed to allow the spring to relax. The spring is carefully selected to ensure that the septum can be pierced with sufficient momentum, and optionally to ensure that another sterile septum (not shown) can be pierced.

[0147] Finally, the radial protrusion (375) of the cylindrical body (370) has an angled tab (376) at its distal end, the end of which activates a switch (390) to power the electronic system (310), the activation of which occurs at the end of the axial movement of the cylindrical body (370) performed by the relaxation of the spring (350).

[0148] In this way, the removable connecting part (308) provides a fluid connection between the reservoir (203) and the pump system (200) and a power supply to the transdermal drug injection device in a single operation, which is caused by the patient intentionally removing the cover for the purpose of using the medical device. This combination judiciously limits any risk of misoperation and eliminates any risk of contamination until the time of use.

[0149] like Fig.21 As can be seen in FIG. 1 , the adhesive film ( 365 ) has a plurality of tabs ( 364 ) to facilitate grasping and removal by the patient.

Claims

1. A transdermal drug delivery device, comprising: a. Shell; b. Battery (260); c. injection system (100); d. a removable connecting portion (308) for providing a fluid connection between the injection system (100) and a reservoir (203) containing an active ingredient intended to be administered; e. a pump system (200) connected to the movable connection part (308) and the injection system (100) by means of flexible pipes (231, 232, 233) so as to create a fluid network, the pump system (200) being mobile so as to circulate the fluid within the network; f. an electronic system (310) for controlling the driving of the pump system (200), wherein the electronic system (310) is provided with a mechanical switch (390) for powering the pump system using the battery (260); characterised in that the movable connection part (308) has at least one degree of freedom relative to the housing on one side and the reservoir (203) on the other side so as to allow movement, the movable connection part (308) jointly controlling the fluid supply of the pump (200) and the power supply of the electronic system during the movement, - at least a part of said movement of said movable connection part (308) is performed by human mechanical action, - said movable connection part (308) comprises means for fluid connection between said reservoir and said pump, providing on the one hand a disconnection when at rest and providing fluid communication during said movement, - said movable connection part comprises means for activating the power supply of the electrical and electronic components of said device, providing disconnection when at rest and supplying power during said movement.

2. The transdermal drug delivery device according to claim 1, characterized in that: The movable connecting part (308) is also intended to receive the reservoir (203) in the form of a vial that can be removed from the transdermal drug delivery device, and when receiving the reservoir (203), the movable connecting part (308) moves according to the at least one degree of freedom.

3. A transdermal drug delivery device according to the preceding claim, characterized in that The reservoir (203) is connected to the removable connection part (308) via an adapter part (311) pre-connected to the reservoir (203), the removable connection part (308) and the adapter part (311) having complementary central conduits (320, 321) which fit together to form a sealed connection.

4. A transdermal drug delivery device according to the preceding claim, characterized in that The complementary central pipes (320, 321) form the sealed connection by means of a conical fit.

5. A transdermal drug delivery device according to the preceding claim, characterized in that The tapered fit formed by the complementary central conduits (320, 321) is of the "Luer" type.

6. A transdermal drug delivery device according to the preceding claim, characterized in that The movable connecting part (308) has a cylindrical body (341) provided with a tap (330), the adapter part (311) has a hollow cylindrical protrusion (340), the center pipe (321) leads to the hollow cylindrical protrusion, and the hollow cylindrical protrusion (340) has a thread (331) on its inner surface that engages with the tap (330) to ensure a tight fit of the center pipe (320, 321) by screwing the adapter part (311) and the movable connecting part (308), ensuring that the seal exceeds the nominal tightening torque.

7. A transdermal drug delivery device according to the preceding claim, characterized in that The degree of freedom of the movable connection part (308) for activating the switch (390) is a rotational degree of freedom achieved by guiding the movable connection part (308) in the lower shell (107) of the housing, the movement path of the movable connection part is angular, and the movable connection part (308) has a partial annular protrusion (384) axially extending the cylindrical body (341) over a limited angular portion, and the partial annular protrusion (384) is capable of activating the switch (390) located radially near the movable connection part (308) at the end of the stroke.

8. A transdermal drug delivery device according to the preceding claim, characterized in that The movement path of the movable connection part (308) is traversed by a rotational movement which results in the screwing of the adapter part (311) with the movable connection part (308).

9. The transdermal drug delivery device according to any one of claims 2 to 8, characterized in that: According to the at least one degree of freedom, the movement path of the movable connection part (308) has a notch at the end of the stroke to lock the movable connection part (308) in a final position, the notch requiring the application of excess torque and reaching the final position, and the switch (390) is activated in the final position.

10. The transdermal drug delivery device according to the preceding claim, characterized in that The excess torque required to pass through the recess and reach the final movement position of the movable connection part (308) is greater than the nominal tightening torque used to screw the adapter part (311) to the movable connection part (308), thereby ensuring the sealing fit of the central pipe (320, 321).

11. A transdermal drug delivery device according to the preceding claim, characterized in that The movable connecting part (308) has two cylindrical axial protrusions (381, 382) extending from the cylindrical body (341), which extend into the lower shell (107) of the housing and simultaneously abut flanges (912, 913) during the course of the moving path of the movable connecting part (308), the flanges (912, 913) being protrusions of a flexible beam (922, 923) integral with the lower shell (107), the abutment position of the axial protrusions (381, 382) against the flanges being able to be exceeded by the elastic deformation of the elastically deformable flexible beams (922, 923) to reach the final moving position of the movable connecting part (308), whereby the recess is realized by the elastic deformation of the flexible beams (922, 923).

12. A transdermal drug delivery device according to the preceding claim, characterized in that The adapter portion (311) is screwed onto the removable connection portion (308) by a user.

13. A transdermal drug delivery device according to the preceding claim, characterized in that When the user applies excessive torque to pass the notch, the deformation and release of the flexible beams (922, 923) provides tactile information that signals activation of the switch (390) and, therefore, the device.

14. The transdermal drug delivery device according to any one of claims 6 to 13, characterized in that: The movable connecting part (308) has a radial protrusion (383) and a partial annular protrusion (384), and the final position of the movable connecting part (308) is achieved by making the radial protrusion (383) and the partial annular protrusion (384) contact with complementary stop members (915, 916) of the lower shell (107) of the housing respectively.

15. The transdermal drug delivery device according to claim 1, characterized in that: The movable connecting part (308) is provided with a hollow needle (315) connected to a flexible tube (231), the hollow needle (315) being adapted to be inserted into the reservoir (203) when the movable connecting part (308) undergoes a translational movement to reach a final state.

16. A transdermal drug delivery device according to the preceding claim, characterized in that The translational movement is caused by a spring (350).

17. A transdermal drug delivery device according to the preceding claim, characterized in that In the initial state, the movable connection part has no translational degree of freedom and has only one translational degree of freedom when the spring is in the compressed state.

18. A transdermal drug delivery device according to the preceding claim, characterized in that The first rotational movement of the movable connecting part (308) is performed by the patient's mechanical action to bring the movable connecting part (308) into an intermediate state, in which the movable connecting part obtains the translational freedom, thereby allowing the hollow needle (315) to be inserted into the reservoir (203).

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