Injection device for injecting gas under the skin, assembly and associated method

Abstract

Injection device for subcutaneous gas injection, assembly and associated method. The present invention relates to a gas injection device (16) comprising: - a body (18), extending around a central axis (A-A'), - an application head (22) defining a bearing surface (46) of the device (16) on a body surface (13), - a fluidic system (20) extending within the body (18) around the central axis (A-A'), the fluidic system (20) comprising a gas reservoir and having a needle attachment member (56) for receiving a microneedle (58) and a gas distribution system connecting the reservoir to the attachment member (56), - an actuating member (24) mounted on the body (18) movable in translation along the central axis (A-A') around the fluidic system (22), - a detachable microneedle (58) configured to be fixed on the fixing member (56) of the actuating member (24). Figure for the abbreviation: figure 2

Description

Title of the invention: Injection device for injecting gas under the skin, assembly and associated method

[0001] The present invention relates to a gas injection device, in particular a carbon dioxide device, intended for subcutaneous gas injection, comprising:

[0002] - a body, extending around a central axis,

[0003] - an application head, located at an axial end of the body and defining a support surface of the device on a body surface,

[0004] - a fluidic system extending in the body around the central axis, the system fluidic system comprising a gas reservoir configured to hold a determined quantity of gas, and having a needle attachment member axially located on the application head side, intended to receive a microneedle and a gas distribution system fluidly connecting the reservoir to the needle attachment member to inject gas from the reservoir into the microneedle,

[0005] - an actuating member mounted on the body around the central axis, the member actuation comprising an internal portion located inside the body and an actuation portion located outside the body at the end of the body opposite the application head, the actuation member being movable in translation along the central axis around the fluidic system,

[0006] - a detachable microneedle, having a length of less than 250 pm, configured to be fixed on the fixing member of the actuation member so as to be in fluidic communication with the gas reservoir.

[0007] Such a device is intended in particular for self-injection of gas under the skin. The gases that can be injected are notably chosen from among biocompatible gases such as carbon dioxide, nitrous oxide, nitric oxide, oxygen, or hydrogen. Advantageously, the injected gas is carbon dioxide.

[0008] The injection of gas, in particular carbon dioxide, under the skin is a cosmetic procedure used in the aesthetic treatment of various skin problems, in particular the reduction of dark circles.

[0009] Dark circles are a common facial feature. The appearance of dark circles, exacerbated by the physiological aging of the face, affects men and women of all ages and is often a significant aesthetic concern due to the tired appearance they give to the eyes.

[0010] To this end, the injection of gas, in particular carbon dioxide, into the stratum corneum, which is the outermost part of the epidermis, contributes in particular to the improvement It oxygenates the skin and promotes better blood circulation, which improves the aesthetic appearance of the skin in the treated areas.

[0011] Carbon dioxide injection also stimulates collagen production and provides anti-inflammatory properties. Clinically observed cosmetic benefits include improved pigmentation of the under-eye area and brightening of the eye contour.

[0012] Injected into the skin layers, the gas acts advantageously on the physical, mechanical and / or optical characteristics of the skin, in particular of dark circles, both inside and outside, in particular on elasticity, volumetric suppleness, tone, firmness, luminosity, radiance, but also on the appearance of the skin surface, by improving its softness, relief, radiance and / or color.

[0013] Since such injections aim to introduce gas into the outermost layer of the skin, the injection depth is therefore very shallow. Generally, such procedures are carried out by injection using a short needle, known as a microneedle, having, for example, a length between 0.1 mm and 10 mm.

[0014] Subcutaneous carbon dioxide injection devices are known which are intended to be used by qualified professionals, for example by a doctor or a nurse.

[0015] Existing devices for injecting gas under the skin are therefore not optimized for home use, let alone for self-injection. For example, they do not have safety systems that would allow them to be used for self-injection. Proper use of these existing devices by non-professionals is not easy and can lead to health or hygiene risks if too much gas is injected or if hygiene precautions are not taken.

[0016] Also, such devices are generally connected to an external gas tank, which makes their use at home complex.

[0017] One object of the invention is to provide a gas injection device that can be used by an individual to practice, in particular, safe self-injection, the device facilitating handling at home, while minimizing the risks of errors.

[0018] To this end, the invention relates to a device of the aforementioned type, characterized in that the fluidic system is mounted to move in translation along the central axis relative to the body, by displacement of the actuating portion of the actuating member, between a rest configuration in which the fixing member is in a retracted position, the microneedle fixed to the fixing member being received in the body and / or in the application head, and a dispensing configuration in which the fixing member is in a deployed position, the microneedle making axially projecting from the bearing surface of the application head, the gas delivery system being active between the rest configuration and the delivery configuration to deliver a dose of gas from the reservoir to the fixation organ, the dose of gas being intended to be delivered through the microneedle, to inject the dose of gas under the body surface.

[0019] The presence of a mobile fluidic system in the body of the device and easily actuated by the user by means of the delivery organ makes it possible both to protect the microneedle before use, while ensuring a reproducible movement of the microneedle towards the user's skin during delivery and simultaneously a controlled injection of gas, reproducing that carried out by medical personnel.

[0020] Since the fluidic system has its own reservoir, this injection is performed without needing to connect the device to a gas source before injection. Thus, the device is simple and ergonomic to use, while ensuring user safety and reproducibility of the needle movement, even for a user without medical training.

[0021] In the device according to the invention, the application surface further ensures precise and stable positioning with respect to the area to be treated, which guarantees accuracy and safety of use, reducing handling errors.

[0022] According to one variant, the device comprises the following feature: - The fixation member is rotationally mobile around the central axis between an intermediate configuration of the actuating member and the actuating member's distribution configuration, the microneedle advantageously being in the deployed position in the intermediate configuration.

[0023] Rotating the microneedle allows it to penetrate the skin more effectively. Indeed, since a microneedle has small dimensions, simply translating it may be insufficient to allow it to penetrate the skin.

[0024] According to one variant, the device comprises the following feature: - the internal portion of the actuation member defines a helical groove around the central axis and the fluidic system includes a first guide pin inserted in the helical groove, the body defining a groove, preferably L-shaped, having an axial segment parallel to the central axis and a circumferential segment around the central axis, the fluidic system including a second guide pin inserted in the axial segment between the rest configuration and the intermediate configuration and inserted in the circumferential segment between the intermediate configuration and the distribution configuration.

[0025] Thus, the drive system for the fixing member in translation and then in rotation contains only mechanical elements and allows a translation followed by a rotation to be applied by simple pressure on the actuating portion.

[0026] According to one variant, the device comprises the following feature: - the gas distribution system is configured to perform a gas purge intended to purge the fixing member and the microneedle between the rest configuration and the distribution configuration.

[0027] Such a purging allows the microneedle to be cleaned by ejecting residues from previous injections, or dust that may have entered the microneedle. This improves hygiene during the use of the device.

[0028] According to one variant, the device comprises the following feature: - the application head is fixed in a removable manner to the axial end of the body.

[0029] Having a removable application head makes access to the fixing element simpler for the user, allowing the fixing or removal of the microneedle to be easier.

[0030] According to one variant, the shutter capsule comprises the following feature: - the application head is made at least partly of a deformable material, so that the application of a force along the central axis generates a radial force directed away from the central axis on the bearing surface.

[0031] The use of deformable material induces deformation of the application head when pressure is applied by the user, for example, when positioning the support surface. This deformation applies a radial force that stretches the skin. Stretching the skin makes needle penetration easier.

[0032] According to one variant, the device comprises the following feature: - the fixation device includes a tip configured for fixing the microneedle, in particular a LUER® tip.

[0033] The presence of such a tip makes it possible to control the type of microneedle fixed on the device, in particular by using a standardized system.

[0034] According to one variant, the device comprises the following feature: - an indicator configured to provide representative information about the amount of gas present in the tank.

[0035] Such an indicator is useful for the user, who can, for example, receive audible or haptic feedback when all the gas has been injected. This indicator also serves as a safety system, indicating that the gas tank is correctly filled.

[0036] According to one variant, the device comprises the following feature: - an indicator configured to provide representative information on the positioning of the device's bearing surface on the application area, including in particular a force sensor.

[0037] The correct positioning of the bearing surface on the application area is necessary in order to make the device usable for self-injection purposes.

[0038] In particular, the force applied to the support surface contributes to the stability of the positioning during the gas injection operation in the application area.

[0039] According to one variant, the device comprises the following feature: - a usage control system configured to limit the number of times the device can be used without recharging.

[0040] Multiple use of the device without recharging should be avoided, as an insufficient quantity of gas is then likely to be injected.

[0041] According to one variant, the device comprises the following feature: - the fluidic system includes a gas filling nozzle in the tank, the filling nozzle protruding axially from the body, opposite the application head.

[0042] The gas filling nozzle allows for regular refilling of the gas tank by inverting it and applying force to make the nozzle cooperate with a gas orifice linked to a gas chamber. This simplifies the process, and the user can perform several injections before refilling.

[0043] The invention also relates to an injection assembly comprising an injection device as defined above and a docking station, the docking station comprising;

[0044] - a receiving space for receiving the injection device,

[0045] - a gas capacity defining a gas delivery head configured for to cooperate with the fluidic system to deliver a predetermined quantity of gas into the fluidic system's reservoir,

[0046] - a housing for receiving the microneedle received in a protective case, configured to fix the microneedle to the fixation device while retaining the protective sheath,

[0047] - a microneedle deactivation housing after use, configured for remove the microneedle from the fixation device.

[0048] The gas injection assembly allows the user to have all the necessary utilities for the injection device in a docking station, in a convenient and safe manner.

[0049] In particular, the fixation of the microneedle is made easy by the receiving housing, and safety is improved by the presence of a microneedle deactivation housing.

[0050] According to one variant, the assembly comprises the following feature: - the docking station includes a locking fork for a microneedle case, arranged in the microneedle receiving compartment, the protective case being insertable into the locking fork to be locked by the locking fork.

[0051] The locking fork holds the microneedle and its case in the docking station, ensuring that the fork is in contact with the protective case to prevent contamination of the microneedle. This reduces the risk of microbial contamination.

[0052] According to one variant, the assembly comprises the following feature: - the docking station includes a microneedle stabilization fork after use, disposed in the deactivation housing, the fixation device equipped with the microneedle being insertable into the stabilization fork by stabilizing the microneedle against the stabilization fork.

[0053] Thus, the microneedle can be attached to the fixation device and then removed using the locking fork to remove the protective sheath. In this way, the user does not come into direct contact with the microneedle, reducing the risk of injury and contamination of the microneedle.

[0054] According to one variant, the assembly comprises the following feature: - the docking station includes a microneedle breakage deformation track, disposed in the deactivation housing.

[0055] The deformation track by breakage makes it possible to deactivate the microneedle by deformation when it is removed from the device, so that the microneedles cannot cause injuries, in particular when the user then has to handle the microneedle.

[0056] According to one variant, the assembly comprises the following feature: - a sterilization system to clean the fixation device and / or the microneedle.

[0057] Sterilization of the fixation device prevents contamination of the microneedle by elements present in the fixation device which would be displaced by the pressure of the injected gas.

[0058] The invention also relates to a non-therapeutic aesthetic method of injecting gas into a body surface, comprising the following steps;

[0059] - supply of an injection device as defined above,

[0060] - fixing a microneedle onto the fixation element of the device,

[0061] - preferably, gas loading of the gas tank,

[0062] - bringing the bearing surface into contact with an application area located on the skin of the user,

[0063] - pressure applied by the user to the actuating portion of the actuating element between the resting configuration and the dispensing configuration, in order to insert the microneedle into the application area and inject gas into the application area,

[0064] then,

[0065] - deactivation of the microneedle and withdrawal of the microneedle from the organ of fastening.

[0066] The method of using the previously described device for purely cosmetic purposes is suitable for repeated self-injections, by implementing easy recharging of the device between applications. This method also contributes to user safety, as the microneedle, which can be dangerous if mishandled, is systematically deactivated when the injection device is removed.

[0067] The invention will become clearer upon reading the following description, given solely by way of non-limiting example, and made with reference to the drawings in which:

[0068] - [Fig. 1] [Fig. 1] is a perspective view of a gas injection assembly according to the invention;

[0069] - [Fig.2] [Fig.3] [Fig.4] Figures 2 to 4 are cross-sectional views along an axial plane median of an injection device according to the invention, during the implementation of a gas injection into the skin using a microneedle.

[0070] A gas injection assembly 10 according to the invention intended for injecting gas into skin tissue is illustrated in [Fig.1].

[0071] The assembly 10 is intended in particular for the injection, in particular for self-injection, by a non-medically qualified user, of carbon dioxide, into the cutaneous layers of the skin, above the dermo-epidermal junction, at a depth less than or equal to 250 micrometers, better at 100 micrometers, better still at 50 micrometers.

[0072] The injection assembly 10 includes a docking station 12 and a gas injection device 16, intended to be grasped by a user's hand to be moved in relation to the body surface 13 (see [Fig.2]) in which the injection is to be carried out.

[0073] The body surface 13 includes in particular at least one area showing signs of skin aging and fatigue, such as dark circles, wrinkles, skin folds, in particular facial folds, or pigmentation, or even scars for example due to acne.

[0074] With reference to [Fig. 2], the injection device 16 comprises a body 18 extending around a central axis A-A', and a gas delivery fluidic system 20, movably mounted within the body 18. The device 16 comprises, at an axial end distal to the body 18, an application head 22, advantageously removable and, at a proximal axial end of the body 18, an actuation member 24 of the fluidic system 20 to generate the injection of gas into the body surface 13.

[0075] In what follows, the terms “internal” and “external” generally refer to the central axis A-A’ of the device. The terms “distal” and “proximal” generally refer to the hand of a user operating the injection device 16, with “proximal” meaning closer to the user’s hand and “distal” meaning further from the user’s hand and closer to the body surface 13.

[0076] The body 18 has a hollow cylindrical envelope 26 extending around the central axis A-A' and a guide sleeve 28, located at a distal end of the body 18.

[0077] The cylindrical envelope 26 internally delimits a straight groove 27 for guiding the translation of the fluidic system 20 along the axis A-A', which extends parallel to the central axis A-A'.

[0078] The guide sleeve 28 has a substantially cylindrical shape, the maximum cross-section of which has a diameter less than the diameter of the maximum cross-section of the envelope 26. The sleeve 28 defines with the envelope 26, at the distal end of the envelope 26, a shoulder 36, which corresponds to the variation in cross-section of the body 18.

[0079] The guide sleeve 28 internally defines a guide groove 30 for the fluidic system 20 rotating around the axis A-A', in the shape of an L.

[0080] The groove 30 has a proximal axial segment 31, parallel to the central axis A-A', and a distal circumferential segment 32, extending around the axis A-A'.

[0081] In addition, the sleeve 28 here includes an external thread 34 for mounting the application head 22, which is here located axially between the groove 30 and the shoulder 36.

[0082] The application head 22 is a part of revolution extending around the axis A-A', when mounted at the distal end of the body 18.

[0083] The application head 22 has a cylindrical proximal base 40 and a distal tip 44 for application on the body surface 13, extending the base 40 distally.

[0084] The base 40 has an external cross-section substantially equal to that of the body's casing 26. It is provided with an internal thread 38 on its internal surface. The internal thread 38 of the application head 22 is configured to engage with the external thread 34 of the sleeve 28, in order to connect the application head 22 and the body 18 in a removable manner.

[0085] In an alternative (not shown), the application head 22 and the body 18 are assembled by simple mechanical interlocking or, in another alternative, in a non-dismountable manner.

[0086] The application head 22 includes a tip 44 defining a bearing surface 46 of the device 16, the bearing surface 46 having an axial opening leading out along the central axis A-A'.

[0087] Advantageously, the tip 44 is formed of a deformable material, for example rubber.

[0088] In this example, the tip 44 comprises a region converging towards the axis A-A' from the base 40 and an application collar projecting radially around the axial opening. The application collar defines the bearing surface 46 which here extends annularily around the axis A-A', transversely with respect to the axis A-A'.

[0089] The actuation member 24 is configured to be moved by a user in translation along the axis A-A' in the body 18, between a rest configuration, visible on [Fig.2], an intermediate configuration, visible on [Fig.3], and a gas distribution configuration, visible on [Fig.4].

[0090] The actuation member 24 comprises an internal portion 48 of hollow shape located inside the body 18 and an actuation portion 50 located outside the body 18, which partially covers the body 18 of the device 16.

[0091] The actuation portion 50 is configured to be grasped and / or pushed by the fingers of a user to cause the translational movement of the actuation member 24 along the axis A-A'.

[0092] The internal portion 48 is interposed between the envelope 26 and the fluidic system 20. It defines a helical groove 51 around the central axis A-A'.

[0093] The internal portion 48 includes a guide pin 52 which projects radially away from the axis A-A'. The guide pin 52 cooperates with the straight groove 27 of the body 18, in order to guide the actuating member 24 in translation relative to the body 18 along the axis A-A'.

[0094] The length, taken along the central axis A-A', of the straight groove 27 defines the stroke of the actuating member 24 relative to the body 18 between the rest configuration and the gas distribution configuration.

[0095] The fluidic system 20 extends along the axis A-A'. It is received at least partially inside the internal portion 48 of the actuation member 24.

[0096] It has a distal end extending into the sleeve 28 and, at least in the resting configuration, a proximal end projecting axially from the body 18. It includes a gas reservoir for injecting pressurized gas (not shown).

[0097] The distal end of the fluidic system 20 includes a fixing member 56, configured for the fixing of a microneedle 58. The fixing member 56 is located opposite the axial opening provided in the bearing surface 46.

[0098] The fastening member 56 includes, for example, a fastening tip for a microneedle 58, for example a LUER® tip. It is connected upstream to the gas reservoir to be injected.

[0099] The proximal end of the fluidic system 20 has a filling nozzle 60, which communicates with the gas reservoir upstream of it.

[0100] The fluidic system 20 also includes a gas distribution system (not visible) equipped with a distribution valve, which allows a predetermined dose of gas located in the gas reservoir to be ejected through the fixing member 56 by actuation of the distribution valve when the actuation member is moved between the intermediate configuration and the gas distribution configuration.

[0101] Advantageously, the fluidic system 20 includes a purge system (not visible) advantageously equipped with a purge valve, which allows a quantity of gas to be ejected through the fixing member 56, prior to the gas dose, in order to clean the internal conduits of the fluidic system 20, the fixing member 56 and the microneedle 58.

[0102] In addition, the fluidic system 20 includes a first guide pin 62, inserted in the helical groove 51 and a second guide pin 64 inserted in the L-shaped groove 30. The guide pins 62, 64 here protrude radially away from the axis A-A'.

[0103] The microneedle 58 is attached to the fixation member 56 by its base in a detachable manner, so that it can be changed from one use to another. The microneedle 58 preferably has a length of less than 250 pm, in particular less than 150 pm.

[0104] The microneedle 58 has an internal channel connecting the base and a tip in fluidic communication, so that the gas delivered to the fixation member 56 is ejected by the tip of the microneedle 58.

[0105] The microneedle 58 is initially disposed in a cylindrical protective case, one end of which is closed, the other end being open. The protective case has a shoulder at its open end, protruding from which is the base of the microneedle 58.

[0106] Examples of microneedles 58 are described in documents EP 2 594 313 or US 8,236,368.

[0107] In the rest configuration, shown in [Fig.2], the actuating member 24 is furthest axially from the application head 22. The guide pin 52 is located at the proximal end of the axial groove 27.

[0108] The first guide pin 62 is located at the distal end of the helical groove 51, closest to the application head 22. The second guide pin 64 is located abutted in the axial segment 31 of the groove 30, at the proximal end of the axial segment 31.

[0109] In this position, the microneedle 58 is entirely within the body 18 and / or the application head 22, and the fixation member 56 is in a retracted position. The risk of accidental puncture and / or damage to the needle is therefore very limited.

[0110] In the intermediate configuration, visible in [Fig.3], the actuating member 24 moved exclusively in translation towards the axis A-A' towards the application head 22, driving the fluidic system 20 distally in translation along the axis A-A' until the stop of the second guide pin 64 at the distal end of the axial segment 31 of the groove 30.

[0111] In this [Fig. 3], the arrows associated with the body surface represent the radial force exerted by the tip 44, made of deformable material, when it is deformed under the effect of an axial force, for example applied by the user. This radial force is applied to the body surface 13, for example the user's skin, to stretch it by placing it under tension.

[0112] The first guide pin 62 remains located at the distal end of the helical groove 51, closest to the application head 22. The fixing member 56 of the microneedle 58 is in a deployed position, protruding from the bearing surface 46.

[0113] In the gas distribution configuration visible in [Fig.4], the actuating member 24 is closest axially to the application head 22. The guide pin 52 is located at the distal end of the axial groove 27. In this [Fig.4], the arrows associated with the body surface represent the radial force exerted on the body surface 13 generated by the deformation of the nozzle 44.

[0114] The fluidic system 20 has pivoted around the axis A-A' relative to the actuating member 24 and relative to the body 18, without axial displacement relative to the body 18.

[0115] The second pin 64 is against the circumferential segment 32 of the groove 30, having moved angularly away from the axial segment 31 around the axis A-A'. The first guide pin 62 is moved up towards the distal end of the helical groove 51, having pivoted around the axis A-A'.

[0116] Advantageously, the device 16 includes a spring (not shown), interposed between the fluidic system 20 and the body 18. This spring is compressed as the fluidic system 20 is translated along the central axis A-A' from the rest configuration to the fluid distribution configuration. Thus, the spring spontaneously induces the return of the fluidic system 16 and the actuating member 24. in rest configuration in the absence of external force applied to the actuation member 24.

[0117] Advantageously, the device 16 includes an indicator (not shown) that provides representative information about the quantity of gas present in the gas reservoir of the fluidic system 20. The indicator is, for example, a visual, audible, or haptic indicator. The function of such an indicator is to assure the user that the device 16 is properly charged and thus prevent incomplete injection.

[0118] Alternatively, the device 16 includes an indicator that provides information representative of the proper positioning of the bearing surface 46 relative to a selected application area 47. In particular, this indicator includes a force sensor for measuring the force applied to the application area 47.

[0119] Alternatively, the device 16 includes a usage control system configured to limit the number of times the device can be used without refilling. The usage control system may, in particular, include a stopwatch to measure the time between two uses of the device 16 without refilling the gas reservoir of the fluidic system 20, or the number of movements of the actuating member 24 in the absence of refilling.

[0120] With reference to [Fig. 1], the docking station 12 includes a housing which defines a receiving space 70, here in the form of a vertical notch, to accommodate the device 16, particularly when the application head 22 is detached from the body 18. This space is delimited downwards by a bearing surface 71 of the sleeve 28 having a through groove 72. The through groove 72 provides a passage for the fixing member 56 of the fluidic system 20.

[0121] The docking station housing 12 also contains a gas reservoir which has a gas delivery head 74. The filling nozzle 60 of the device 16 is configured to be removably mounted on the gas delivery head 74, in order to deliver a determined quantity of gas to the gas reservoir of the fluidic system 20.

[0122] The housing of the docking station 12 further delimits a storage hollow for the application head 22 which is here arranged between the receiving space 70 and the gas delivery head 74.

[0123] The housing of the docking station 12 also defines a receiving housing 76 configured to guide the insertion of the microneedle 58 into the fixation member 56.

[0124] The receiving housing 76 includes in its base a recess 79 which accommodates the closed end of the protective case, in which the microneedle 58 is received.

[0125] In addition, the receiving housing 76 contains a locking fork 78 for the protective case. The protective case is configured to be inserted into the housing of reception 76, between the recess 79 and the locking fork 78, with the shoulder of the protective sheath in contact with the locking fork 78. This allows the base of the microneedle 58 to protrude from the locking fork 78, permitting the introduction of the fixing member 56 into the base of the microneedle 58.

[0126] The housing of the docking station 12 also defines a deactivation slot 80, configured to deactivate the microneedle 58 after use, in particular to prevent accidents related to the handling of the microneedle 58. The deactivation slot 80 also allows the microneedle 58 to be separated from the fixation member 56 without contact with a user's fingers.

[0127] In one embodiment, the deactivation housing 80 includes in its base a deformation track for breaking the microneedle 58. For example, this track is formed by a protruding stud with a shape converging towards a vertex which deforms the microneedle 58 when pressure is exerted on the microneedle 58 by contact of the tip of the microneedle 58 on the track.

[0128] The deactivation housing 80 also contains a shim 82, which is configured to retain the microneedle 58 when the fixation member 56 is moved away from the deactivation housing 80. The base of the microneedle 58 is able to be wedged between the shim 82 and the bottom of the deactivation housing 80, so that the shim 82 retains the base of the microneedle 58 to separate the microneedle 58 when the fixation member 56 is moved away from the deactivation housing 80.

[0129] In one variant (not shown), the docking station 12 includes a sterilization system for cleaning in particular the fixation organ 56 of the device 16 and / or the microneedle 58. Indeed, since the device 16 is intended for subcutaneous injection, sterilizing the organs of the system in fluidic communication ensures improved safety, in particular when these organs are likely to be contaminated.

[0130] A method of use by a user wishing to perform a gas injection, in particular a self-injection of gas using an assembly 10, will now be described.

[0131] The user first takes a microneedle 58 received in a protective case and places it in the receiving compartment 76 of the docking station 12 visible in [Fig. 1]. The user then wedges the protective case between the recess 79 and the locking fork 78, with the shoulder of the protective case in contact with a lower surface of the locking fork 78.

[0132] The device 16 is then extracted from its receiving space 70, to place the fixation member 56 opposite the base of the microneedle 58 above the receiving housing 76.

[0133] The microneedle 58 is then fixed to the fixation member 56, for example by moving the fixation member 56 towards the recess 79.

[0134] The device 16 is then moved away from the recess 79, and the protective sheath is detached from the microneedle 58 by being held in the locking fork 78.

[0135] The application head 22 is then fixed onto the body 18, so that the microneedle 58 is located inside the application head 22 or the body 18.

[0136] The fixation member 56 is then in a retracted position in which the microneedle 58 fixed on the fixation member 56 is received in the application head 22.

[0137] Next, the user charges the device 16 with gas, by turning the device over so that the filling nozzle 60 of the device 16 cooperates with the gas delivery head 74 of the docking station 12.

[0138] The gas reservoir of the fluidic system 20 is then filled with a quantity of gas at a determined pressure, in particular by pressure from the device 16 on the gas delivery head 74.

[0139] With reference to [Fig. 2], the user positions the support surface 46 of the device 16 on the application area 47 into which they wish to inject gas. Preferably, they place the device 16 perpendicular to the application area 47.

[0140] When pressure is applied by the user, the collar of the application head 22 deforms radially away from the axis A-A', applying a radial force that stretches the skin (see the arrows in [Fig. 3]). This facilitates the puncture of the microneedle 58.

[0141] The user then applies pressure to the actuation portion 50 of the actuation member 24 towards the application head 22.

[0142] The actuating member 24 moves in translation along the central axis A-A'. The internal portion 48 applies an oblique force on the first guide pin 62 via the helical groove 51, which tends to drive the fluidic system 20 and the microneedle 58 mounted at the end of the fixing member 56 in translation along the central axis A-A' relative to the body 18.

[0143] During the transition from the rest configuration to the intermediate configuration, the second guide pin 64 guides the fluidic system 20 exclusively in translation along the axial segment 31 of the groove 30, until it reaches the stop of the axial segment 31.

[0144] Advantageously, during the movement from the rest configuration to the intermediate configuration, the fluidic system 20 activates its purge system, in order to release a quantity of gas generally less than the dose to be injected, intended to purge the fluidic system 20 as well as the microneedle 58.

[0145] The microneedle thus penetrates the stratum corneum of the skin located in the application area 47.

[0146] Subsequently, between the intermediate configuration and the distribution configuration, the oblique force applied to the fluidic system 20 causes only a rotation about the axis A-A' of the fluidic system 20 and the microneedle 58 mounted on the fixing member 56 relative to the body 18. The second pin 64 is guided along the circumferential segment of the guide sleeve 28. The rotation of the fluidic system 20 relative to the body 18 causes a displacement of the first guide pin 62 along the helical groove 51.

[0147] The fixation member 56 is in a deployed position, the microneedle 58 protruding axially relative to the bearing surface 46 of the application head 22.

[0148] A dose of gas from the fluidic system reservoir is sent into the microneedle 58 by the distribution system, when the actuation member 24 moves from the intermediate configuration to the distribution configuration, to be injected into the chosen application area 47.

[0149] Once the injection has been carried out, the user releases the pressure he was exerting on the actuating member 24. The actuating member 24 and the fluidic system 20 spontaneously return to the rest configuration under the action of the spring between the body 18 and the fluidic system 20.

[0150] Optionally, another injection is carried out, by recharging the device 16 with gas, and then again implementing the steps detailed previously.

[0151] When the user has treated the desired application areas, he proceeds to remove and neutralize the microneedle 58.

[0152] For this purpose, the application head 22 is unscrewed, and the microneedle 58 is inserted into the deactivation housing 80. Pressing the microneedle 58 on the deformation track deactivates the microneedle 58, which is then removed by wedging its base under the wedging fork 82.

[0153] The deactivated microneedle 58 is then housed in its protective case and the user discards it.

[0154] The injection device 16 according to the invention is therefore particularly suitable for use, in conjunction with the docking station 12, by non-specialized personnel. Indeed, it guarantees a reproducible movement of suitable amplitude to puncture the user's skin in a manner similar to an injection that would be performed by medical personnel, by a simple translation of the actuating member 24 along the body 18 over a calibrated stroke.

[0155] The application head 22 and the indicators limit the risk of accidental puncture and prevent inappropriate use by the user and injuries resulting from the handling of the microneedle 58.

Claims

1. Demands Gas injection device (16), in particular for carbon dioxide, intended for subcutaneous gas injection, comprising: - a body (18), extending around a central axis (A-A'), - an application head (22), located at an axial end of the body (18) and defining a bearing surface (46) of the device (16) on a body surface (13), - a fluidic system (20) extending in the body (18) around the central axis (A-A'), the fluidic system (20) comprising a gas reservoir configured to carry a determined quantity of gas, and having a needle fixing member (56) axially located on the side of the application head (22), intended to receive a microneedle (58) and a gas distribution system fluidly connecting the reservoir to the needle fixing member (56) to inject gas from the reservoir into the microneedle (58), - an actuating member (24) mounted on the body (18) around the central axis (A-A'), the actuating member (24) comprising an internal portion (48) located inside the body (18) and an actuating portion (50) located outside the body (18) at the end of the body (18) opposite the application head (22), the actuating member (24) being movable in translation along the central axis (A-A') around the fluidic system (22), - a detachable microneedle (58), having a length of less than 250 pm, configured to be fixed to the fixing member (56) of the actuating member (24) so ​​as to be in fluidic communication with the gas reservoir, characterized in that the fluidic system (20) is mounted to move in translation along the central axis (A-A') relative to the body (18), by displacement of the actuating portion (50) of the actuating member (24), between a rest configuration in which the fixing member (56) is in a retracted position, the microneedle (58) fixed to the fixing member (56) being received in the body (18) and / or in the application head (22), and a distribution configuration in which the fixation member (56) is in a deployed position, the microneedle (58) protruding axially from the bearing surface (46) of the application head (22), the gas delivery system being active between the rest configuration and the delivery configuration to deliver a dose of gas from the reservoir to the fixation member (56), the dose of gas being intended to be delivered through the microneedle (58), to inject the dose of gas under the body surface (13).

2. Device (16) according to claim 1, wherein the fixing member (56) is rotationally movable about the central axis (A-A') between an intermediate configuration of the actuating member (24) and the distribution configuration of the actuating member (24), the microneedle (58) advantageously being in the deployed position in the intermediate configuration.

3. Device (16) according to claim 2, wherein the internal portion (48) of the actuating member (24) defines a helical groove (51) around the central axis (A-A') and the fluidic system (20) comprises a first guide pin (62) inserted in the helical groove (51), the body (18) defining a groove (30), preferably L-shaped, having an axial segment (31) parallel to the central axis (A-A') and a circumferential segment (32) around the central axis (A-A'), the fluidic system (20) comprising a second guide pin (64) inserted in the axial segment (31) between the rest configuration and the intermediate configuration and inserted in the circumferential segment (32) between the intermediate configuration and the distribution configuration.

4. Device (16) according to any one of the preceding claims, wherein the gas distribution system is configured to perform a gas purge intended to purge the fastening member (56) and the microneedle (58) between the rest configuration and the distribution configuration.

5. Device (16) according to any one of the preceding claims, wherein the application head (22) is detachably fixed to the axial end of the body (18).

6. Device (16) according to any one of the preceding claims, wherein the application head (22) is made at least partly of a deformable material, so that the application a force along the central axis (A-A') generates a radial force directed away from the central axis (A-A') on the support surface (46).

7. Device (16) according to any one of the preceding claims, wherein the fastening member (56) comprises a tip configured for fastening the microneedle (58), in particular a LUER® tip.

8. Device (16) according to any one of the preceding claims, comprising an indicator configured to provide representative information on the quantity of gas present in the tank.

9. Device (16) according to any one of the preceding claims, comprising an indicator configured to provide representative information of the positioning of the bearing surface (46) of the device on the application area (47), including in particular a force sensor.

10. Device (16) according to any one of the preceding claims, comprising a usage control system configured to limit the number of uses of the device (16) without recharging.

11. Device (16) according to any one of the preceding claims, wherein the fluidic system (20) comprises a gas filling nozzle (60) in the reservoir, the filling nozzle (60) projecting axially from the body (18), opposite the application head (22).

12. Injection assembly (10) comprising an injection device (16) according to any one of the preceding claims and a docking station (12), the docking station (12) comprising: - a receiving space (70) for receiving the injection device (16), - a gas capacity defining a gas delivery head (74) configured to cooperate with the fluidic system (20) to deliver a predetermined quantity of gas into the reservoir of the fluidic system (20), - a receiving housing (76) for the microneedle (58) received in a protective sheath, configured to fix the microneedle (58) to the fixing member (56) by retaining the protective sheath, - a deactivation housing (80) for the microneedle (58) after use, configured to remove the microneedle (58) from the fixation organ (56).

13. Injection assembly (10) according to claim 12, wherein the docking station (12) comprises a locking fork (78) for a microneedle case (58), disposed in the receiving housing (76) of the microneedle (58), the protective case being insertable into the locking fork (78) to be locked by the locking fork (78).

14. Injection assembly according to any one of claims 12 or 13, wherein the docking station includes a microneedle (58) locating fork (82) after use, disposed in the deactivation housing (80), the fixing member (56) provided with the microneedle (58) being insertable into the locating fork (82) by locating the microneedle (58) in contact with the locating fork (82).

15. Injection assembly (10) according to any one of claims 12 to 14, wherein the docking station (12) comprises a microneedle break-deformation track (58), disposed in the deactivation housing (80).

16. Injection assembly (10) according to any one of claims 12 to 15, comprising a sterilization system for cleaning the fixation member (56) and / or the microneedle (58).

17. A non-therapeutic aesthetic method for injecting gas into a body surface (13), comprising the following steps: - providing a device (16) according to any one of claims 1 to 11, - attaching a microneedle (58) to the attachment member (56) of the device (16), - preferably, loading the gas reservoir with gas, - bringing the support surface (46) into contact with an application area (47) located on the user's skin, - pressure by the user on the actuating portion (50) of the actuating member (24) between the resting configuration and the dispensing configuration, in order to insert the microneedle (58) into the application area (47) and inject gas into the application area (47), Then, deactivation of the microneedle (58) and removal of the microneedle (58) from the fixation organ (56).

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