Injection device with microneedle comprising a suction system

Abstract

The invention relates to an injection device (100) with needle for injecting a product, in particular a cosmetic product, the device comprising: a suction chamber (1), a support surface (4) inside the chamber (1) at a position set back from the opening (2), and a suction source, the support surface (4) comprising at least one microneedle (6) for carrying out the injection, the suction opening (2) is closed by an intermediate component (7), defining a contact surface with the target area (3), and having at least one orifice (8) designed to be passed through by the microneedle (6), when the target area (3) is suctioned towards the chamber (1).

Description

Injection device with microneedle comprising a suction system

[0001] The present invention relates to an injection device for the subcutaneous injection of a product, in particular a cosmetic product, comprising a suction system for the skin. It also relates to a cosmetic process comprising the implementation of this device.

[0002] In a first embodiment of the invention, the device is an injection device with microneedle.

[0003] In a second embodiment of the invention, the device is a needleless injection device.

[0004] More generally, a cosmetic product is a product as defined in Regulation (EC) No 1223 / 2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.Technological background

[0005] It is known to use injectable formulations to reduce facial wrinkles and to restore volume and fullness to the face.

[0006] As faces age, they naturally lose subcutaneous fat.

[0007] The facial muscles then work closer to the surface of the skin, so that smile wrinkles and crow’s feet, for example, become more apparent.

[0008] The facial skin also stretches a little, adding a loss of facial volume.

[0009] Other factors that affect facial skin include sun exposure, heredity and lifestyle.

[0010] The stratum corneum (SC) is the main barrier of the epidermis to exogenous substances, including the low and high weight molecular biopolymer compositions used as cosmetic fillers.

[0011] The concept of using a device composed of a plurality of microneedles to pass through the barrier of the stratum corneum was first proposed in the 1970s.

[0012] The production of solid microneedle arrays has been described in the art, for example in applications WO 2009 / 040548, US 2015 / 0141910 and WO 2016 / 076442. Microneedles have the advantage of potentially penetrating the stratum corneum without the discomfort of known needles, and can be self-administered.

[0013] The administration of a substance in the skin can be technically difficult, particularly when it involves an injection at shallow depth, due to factors associated with the person and with the environment, such as anatomy, age, the location of the skin on the body, the climate, the skin condition, such as the roughness or elasticity, these factors varying considerably from one injection to the other. For example, the elasticity of the skin, a bone or fat lead to non-standardized injection conditions. For the injection at shallow depth, the consequence may be high failure rates, and this is problematic notably for apparatuses intended to be used in beauty clinics, retail outlets or, worse still, at home.

[0014] It has already been proposed to suction the skin into a chamber to bring a target area into contact with microneedles.

[0015] Document WO2020064085 discloses an injection device comprising:

[0016] a chamber with an opening configured to face a target area of the skin when the device is applied to the skin,

[0017] a surface inside the chamber at a position set back from the opening, and

[0018] a pressure source in communication with the chamber, at least in order to reduce the pressure in the chamber and bring about the suction of the target area into the chamber and the contact of said skin with the surface,

[0019] the surface comprising microneedles for puncturing the skin in the target area.

[0020] This document discloses that the suction helps the microneedles to puncture the skin and to have the same penetration depth into the skin.

[0021] Document WO2007 / 015247 discloses a device comprising: a) a discharge chamber comprising an essentially rigid interface element through which a medical treatment can be administered at a selected skin region, one or more walls which can be placed on or in the vicinity of said skin region, an interior defined by at least said one or more walls and by said interface element, and an opening at the bottom of said interior that can be sealed by said skin region; b) means for generating a vacuum inside said discharge chamber interior, the level of vacuum applied being suitable for pulling said skin region through said opening towards, and into compressive interaction against, said interface element, so as to inhibit the transmission of a pain signal generated by pain receptors situated in said skin region; and c) means for administering a medical treatment associated with the skin, said administration means being adapted to pass through said interface element and to be directed towards said compressed skin region and inhibiting the pain.

[0022] This document specifies that the administration means can be an injection needle, and the interface element can be pierced by said needle or is provided with a plurality of openings, the injection needle being able to be introduced through each of said openings. The administration means may also be an electromagnetic energy, such as ultrasound waves, a laser light and an IPL light, and the corresponding interface element is transparent or translucent to said electromagnetic energy.

[0023] Still according to this document, in one aspect, the interface element is a perforated interface element, an injection needle being able to be introduced through each of said openings.

[0024] WO2004 / 004803 discloses a device for intradermal administration having a housing containing a syringe for injecting a substance at a predetermined insertion depth and a base assembly for tensioning a target area of skin. One embodiment tensions the skin by vacuum and another by expansion of a mounting surface in contact with the skin. Upon tensioning of the target area, a needle extends into the target area up to the insertion depth. At the insertion depth, a plunger is depressed inside the syringe and delivers the substance through the needle. Once the injection is complete, the needle is retracted, the skin tension is released and the intradermal administration device is removed. As shown in Figure 20, a needle is fixedly fastened at an end of the syringe and is moveable through the needle opening during the actuation of the syringe in order to inject a substance contained in the syringe into the substantially planar needle penetration region X on the skin. In a currently preferred embodiment of the present invention, the needle opening is large enough to allow the needle to pass through. The needle opening is remote from the skin.

[0025] There is a need to standardize the skin surface in order to standardize the product injection and penetration conditions.

[0026] There is a need to improve the delivery of in particular cosmetic compositions in the skin, scalp and lips, notably the precision in the quantity of composition delivered and the control of the injection depth into the skin at the target location.

[0027] There is a need to improve the contact between the target area and the microneedles.

[0028] There is a need to have the same penetration depth for all the microneedles into the skin.

[0029] There is a need to have the same penetration depth over the entire target area / area to be treated.

[0030] Definition of the invention

[0031] First embodiment of the invention: injection device with microneedles

[0032] The invention relates to an injection device with needle for injecting a product, in particular a cosmetic product, the device comprising: a suction chamber with a distal suction opening configured to face a target body area of the skin when the device is applied to the skin, a support surface inside the chamber at a position set back from the opening, and a suction source in communication with the chamber, in order to reduce the pressure in the chamber and bring about the suction of the target area towards the chamber, the support surface comprising at least one microneedle for carrying out the injection, the suction opening is closed by an intermediate component, defining a contact surface with the target area, and having at least one orifice designed to be passed through by at least part of the microneedle, when the target area is suctioned towards the chamber.

[0033] Second embodiment of the invention: needleless injection device

[0034] The invention relates to a needleless injection device for injecting a product, in particular a cosmetic product, comprising: a suction chamber with a distal suction opening configured to face a target area of the skin when the device is applied to the skin, a needleless injection system comprising an injection head provided with an exit hole for the product that is situated at a position set back from the opening, and a suction source in communication with the chamber, in order to reduce the pressure in the chamber and bring about the suction of the target area towards the chamber, the suction opening is closed by an intermediate component, defining a contact surface with the target area, and having at least one orifice through which the product is injected into the target area when the skin is suctioned towards the chamber.

[0035] The use of the device according to the invention offers a lasting solution for correcting signs and disorders of skin ageing, by improving the cutaneous penetration of fillers and / or treatment agents and / or compositions.

[0036] Injected into the skin layers by means of the device according to the invention, the compositions, in particular cosmetic compositions, advantageously act on the physical, mechanical and / or optical characteristics of the skin, inside and outside, in particular on the hydration, elasticity, volume flexibility, tonicity, firmness, brightness and radiance uniformly in the target area, but also on the appearance of the surface of the target area, improving its softness, its relief, its radiance and / or its colour.

[0037] The device according to the invention makes it possible to target and to deliver uniformly into the skin layers compositions that are liquid and / or gaseous or liquid-solid (suspensions) and potentially resorbable and injectable, in order to correct, alleviate and / or eliminate disorders of signs of skin ageing, such as wrinkles, skin folds, notably facial folds, skin depressions, changes to the facial oval, in particular shallow contours, or sagging of certain areas.

[0038] The appearance of certain atrophic scars, due for example to acne, the shape and the volume of the cheekbones and the general loss of volume can also be corrected uniformly over the entire surface of the target area.

[0039] The device according to the invention can also be used to plump up thin lips, limit deformations of the facial contour, reduce or eliminate darkening of the lower eyelids, reduce or correct dark circles.

[0040] The area of target skin is suctioned into the chamber to bring the target area into contact with the microneedle.

[0041] By virtue of the device according to the invention, it becomes possible to:

[0042] standardize the skin surface condition and biomechanical properties,

[0043] standardize the injection (force, pressure required),

[0044] standardize the penetration depth (of needles / cones / needleless injection jets, droplets),

[0045] enable a controlled angle of injection,

[0046] potentially, enable repeated insertion of the needle into the skin.

[0047] The invention described can be used for applications for caring for or making up keratin surfaces.

[0048] The invention also relates to a cosmetic injection process comprising the operations consisting in (i) providing a device as defined above according to the first embodiment of the invention, (ii) positioning the intermediate component in contact with a target area of the skin; (iii) applying a vacuum of sufficient value to said target area of the skin such that the latter is placed and compressed against the intermediate component; and (iv) carrying out the injection by causing the microneedle to pass through the intermediate component and by causing the microneedle to penetrate the skin.

[0049] The invention also relates to a cosmetic injection process comprising the operations consisting in (i) providing a device as defined above, (ii) positioning the intermediate component in contact with a target area of the skin; (iii) applying a vacuum of sufficient value to said target area of the skin such that the latter is placed and compressed against the intermediate component; and (iv) carrying out the injection by causing the cosmetic product emitted by the needleless injection system to pass through the intermediate component.

[0050] Device with microneedles

[0051] The microneedles used according to the invention are known in the art. The microneedles can have any shape.

[0052] A gas may be injected through the microneedles, before or after the delivery of the composition, in particular the cosmetic composition, such as CO2, O2, N2, preferably CO2.

[0053] Hollow microneedles are described in numerous publications such as in the articles "Microneedles for transdermal drug delivery" Advanced Drug Delivery Reviews, volume 56, issue 5, 27 March 2004, pages 581-587, "Biodegradable polymer microneedles: Fabrication, mechanism and transdermal drug delivery", Journal of Controlled Release, volume 104, number 1, 5 May 2005, pages 51-66, "Microfabricated needles for transdermal administration of macromolecules and nanoparticles: manufacturing methods and transport studies, transport studies", Devin V. McAllister et al, PNAS of 25 November 2003.

[0054] Hollow microneedles can have at least one internal channel.

[0055] Such a channel may be longitudinal, that is to say extending along a longitudinal axis of the microneedles, from their free ends to the base of the device, or transverse, that is to say extending along an axis extending obliquely or perpendicularly to the longitudinal axis of the microneedles.

[0056] The microneedles can have a plurality of longitudinal and / or transverse channels.

[0057] The channels passing through the microneedles may be continuous or discontinuous.

[0058] The microneedles can have a circular hollow internal cross section.

[0059] In a variant, the microneedles have a hollow internal section of other shapes, for example square, rectangular or triangular.

[0060] The microneedles may be made of a porous material, preferably capable of being filled with said at least one composition aiming to generate an in situ reaction in the skin, scalp or lips.

[0061] The microneedles may be made of a sintered material.

[0062] The microneedles may be resorbable.

[0063] The term "resorbable microneedles" or "bioresorbable microneedles" or "naturally dissolving microneedles" should be understood to mean that the microneedles dissolve or degrade in vivo, for example after between at least 10 seconds and 24 hours, preferably in less than 8 hours.

[0064] The microneedles may be bioabsorbable or biodegradable.

[0065] The microneedles may dissolve or degrade by virtue of an enzymatic reaction.

[0066] In the case of resorbable microneedles, the microneedles are advantageously manufactured from a material capable of dissolving, being absorbed or degraded by the body and therefore not requiring any mechanical removal.

[0067] The microneedles may be soluble in any bodily fluid or suitable composition.

[0068] In a variant, the resorbable microneedles may inflate in the skin, scalp or lips, that is to say may increase in volume when they are injected into the skin, scalp or lips.

[0069] In the case of resorbable microneedles, at least part of the material from which the microneedles are produced may be used, once injected into the skin, scalp or lips, as cosmetic filler.

[0070] In a variant, the microneedles are non-resorbable.

[0071] The term "non-resorbable microneedles" should be understood to mean that the microneedles do not dissolve or degrade in vivo, and that they have to be removed from the skin.

[0072] The microneedles may not inflate in humidity.

[0073] Each microneedle preferably has a length of less than or equal to 50 mm, better still 20 mm, better still 5 mm, better still 1 mm, better still 0.3 mm, even better still 0.1 mm.

[0074] The length of a microneedle is measured along its axis of elongation from its free end to the point where it connects to the base.

[0075] The expression "axis of elongation of a microneedle" designates an axis passing through the barycentres of the cross sections of the microneedle.

[0076] The external transverse dimension of the microneedles may decrease steadily towards the free ends thereof or it may be constant.

[0077] The microneedles may be configured to deliver a composition at a flow rate of less than or equal to 100 cm3 / min, better still of less than or equal to 60 cm3 / min.

[0078] Each microneedle can comprise a stop configured to limit the injection depth of the microneedle into the skin to less than or equal to 500 micrometres, better still less than or equal to 200 micrometres, even better still less than or equal to 100 micrometres.

[0079] A larger internal transverse dimension of each microneedle, that is to say its diameter when the microneedle has a circular hollow section, may be less than or equal to 1000 micrometres, better still less than or equal to 500 micrometres, even better still less than or equal to 200 micrometres, even better still less than or equal to 100 µm.

[0080] The largest internal transverse dimension of the microneedles can be selected as a function of the desired volume of composition to be dispensed.

[0081] The microneedles are preferably longer than the desired injection depth.

[0082] The length of the microneedles can be selected as a function of the targeted skin layer into which the composition is to be delivered, obtaining the appropriate depth in the skin.

[0083] The microneedles can be oriented perpendicularly to a substantially planar surface along which the base extends.

[0084] In one embodiment variant, the microneedles are oriented obliquely with respect to the substantially planar surface along which the base extends.

[0085] This makes it possible to deliver the composition at curved surfaces with microneedles that are locally perpendicularly oriented.

[0086] The microneedles can have a curved shape.

[0087] The microneedles can have a non-cylindrical shape, notably an octagonal pyramid shape, and a variable diameter over their length.

[0088] The article by O'Mahony C., "Structural characterization and in-vivo Reliability evaluation of silicon microneedles", Biomed Microdevices, 2014, 16(3):333-43 shows that the conical shape results in a very high degree of reliability for silicon microneedles during penetration.

[0089] In variants, the microneedles may have a conical shape with other polygonal bases such as a hexagonal base, or a square shape. The diameter may be identical over the entire length.

[0090] The microneedles may be constituted of an inorganic material, preferably silicon, titanium, stainless steel, cobalt, ceramic, polyethylene or any material implantable in the skin and / or the body.

[0091] The material used for the microneedles may comprise a preservative, notably in the case of ceramic.

[0092] In a variant, the microneedles are made of an organic material, preferably a polymer, such as sugar, polysaccharide, polyethylene, cellulose or hyaluronic acid.

[0093] The material used for the microneedles may be capable of transmitting light and / or heat and / or cold.

[0094] The microneedles are preferably sterile or sterilized prior to use.

[0095] The microneedles are preferably disposable.

[0096] The device may be constituted of multiple baseplates mutually connected to one or more containers containing a composition to be injected.

[0097] In one aspect, the device further comprises means for guiding the injection needle through an opening towards the skin region.

[0098] In one aspect, the apparatus further comprises means for administering a plurality of injection needles, such as a bar for holding a plurality of needle applicators below it and a guide track that is substantially perpendicular to said bar.

[0099] Needleless device

[0100] Needleless injection devices function by creating, for example by means of a plunger moving in a reservoir, a jet of fluid or of powder under extremely high pressure which penetrates the skin.

[0101] The profile of the force exerted by the plunger can be broken down into a first phase of short duration, where the intensity of the force has to be high such that the jet achieves a speed which allows it to pierce the skin, and a second phase, which is longer and of reduced intensity, which injects the desired quantity at the desired depth.

[0102] When the product is a filler, the quantity of product injected is typically from 20 to 100 microlitres and the injection depth is the junction between the dermis and the epidermis.

[0103] The pressure may be generated by means of a plunger driven by a spring, a compressed gas, a pyrotechnic element or a piezoelectric or electromagnetic actuator.

[0104] Needleless devices are for example described in documents US 2007 / 0191758, WO2020161271A1 or US8172790B2.

[0105] Apparatus, control, communication

[0106] The base may be a flexible substrate, preferably coated with adhesive.

[0107] The device may comprise a plurality of rigid bases each bearing one or more microneedles, which are preferably secured thereto, and a flexible support to which the bases are fastened such that the bases can move with respect to one another to conform to the profile of the skin.

[0108] The device may be constituted of multiple baseplates mutually connected to one or more containers containing a composition to be injected.

[0109] The containers can be removed from the apparatus and replaced with new ones while the microneedles are still in the skin.

[0110] The containers may be refillable while still remaining connected to a microneedle array.

[0111] The base may bear between 2 and 1000 microneedles per cm2, better still between 15 and 50 microneedles.

[0112] The number of microneedles per baseplate is advantageously dependent on the target area of the skin to be treated.

[0113] The number of microneedles on a base is advantageously linked to the size of the base, which is dependent on the size of the area of skin to be treated.

[0114] The device may be able to ensure that the microneedles perforate the skin to a deep level and then dispense the composition during removal of the device.

[0115] This makes it possible to obtain a good distribution of the composition in the various layers of the skin.

[0116] The microneedles may or may not be disposed regularly on the base.

[0117] In a variant, the microneedles are disposed in a non-regular manner on the baseplate.

[0118] The base may bear only resorbable microneedles, or only non-resorbable microneedles.

[0119] In a variant, the base bears a mixture of resorbable and non-resorbable microneedles.

[0120] The ratio of resorbable microneedles to non-resorbable microneedles may be between 0 and 1.

[0121] The microneedles of a base may have different lengths, different volumes, different shapes and may be made of different materials.

[0122] The device may be wirelessly connected to an electronic system, notably a personal computer or a smartphone, for controlling the injection.

[0123] In a variant, the device comprises an electronic system.

[0124] Such an electronic system may be designed to calculate, for a set of injection points in said area, obtained on the basis of optical acquisition of the topography of the area, a volume of a composition, in particular a cosmetic composition, to be introduced into the skin in order to obtain a desired correction of the relief in this area, and to calculate a volume of a composition, in particular a cosmetic composition, to be injected into the skin, scalp or lips via each microneedle as a function of the calculated volume at each point and the location of each microneedle in said area during the injection of a composition, in particular a cosmetic composition.

[0125] This makes it possible to obtain a high degree of precision and to avoid errors, notably by preventing risks of excess composition and overflow beyond the area to be filled.

[0126] The device may be capable of delivering heat, cold, ultrasound, a massage function, microcurrents or light, in order to create a synergetic effect on the performance of the composition or in order to enable chemical reactions between different compositions.

[0127] In addition, heat may be useful for maintaining a low viscosity of the composition to facilitate its injection.

[0128] Cold may help to locally anaesthetize the area to be injected.

[0129] An application, notably operating on a smartphone, may be used to control the delivery and the user interface.

[0130] The device may form part of a watch connected to a smartphone or to a remote device connected by wire or wirelessly, for example by radiofrequency, Wi-Fi or Bluetooth®.

[0131] The device may comprise a vibratory system to induce vibrations in the microneedles.

[0132] The vibratory system may also provide a massage function at the treated area, enabling better diffusion of the composition.

[0133] According to one embodiment of the invention, the device may comprise a nonwoven impregnated with a composition, in order to coat the needle just before its cutaneous penetration. The composition may be a disinfecting lotion or an active molecule composition to induce penetration thereof.

[0134] The device may include an optical detection system for synchronizing the movement of the injection system and the movement of the grille, notably in order to position the needle appropriately with respect to the orifices of the grille.

[0135] The device may also include an optical detection / diagnostic system for evaluating the condition of the skin and confirming it prior to injection.

[0136] The device may also include an optical detection system for measuring the distance between the skin and the needle / the injection nozzle.

[0137] The device may also include an interface for the collection of data or analysis.

[0138] The device may also include an on-board light source for facilitating the locating of the injection site on the top of the skin.

[0139] The device may also include pressure elements, potentially rotary pressure elements, for compressing the skin on two lateral sides, enabling the creation of a skin roll / bulge / bump in order to facilitate the injection and standardize the biomechanical properties of the skin.

[0140] Grille

[0141] The intermediate component may notably be a grille, a wall, a surface.

[0142] According to an advantageous embodiment of the device according to the invention, the intermediate component is not in contact with the target area of skin in the retracted position; the suction making it possible to establish this contact prior to the depressed position if the distance between the skin and the intermediate component is sufficiently small.

[0143] A grille is a conceivable intermediate component according to the invention.

[0144] Notably, the grille may be a porous wall, a membrane, a nonwoven, a septum making it possible to press the skin against the porous wall / membrane under the effect of suction.

[0145] The grille is preferably non-absorbent, in other words it is not porous.

[0146] The grille may notably not have the capacity to take in water when it is immersed in water, and hold for example less than 10% water, better still less than 5% of its weight of water, even better still less than 0.5%.

[0147] The grille may notably be made of a solid material. The grille may be a foam, a woven fabric or a felt, a membrane, made of polyurethane for example.

[0148] The surface for contact between the device and the keratin material may be defined by a non-absorbent surface of the grille.

[0149] The region of the grille defining the openings therein may be defined by a non-absorbent part of the grille.

[0150] The grille is preferably removable, in other words it can be easily detached by the user of the device, preferably without the use of a tool. This makes it easier to clean and allows it to be replaced between uses, or even, if so desired, allows multiple grilles to be interchanged depending on the use, for example by selecting the type of grille best suited to the morphology of the area to be cleaned.

[0151] The contact surface defined by the grille may be substantially planar, in order for example to keep a substantially constant distance between the transducer and the keratin material to be cleaned located facing the surface for emission of the acoustic waves.

[0152] In a variant, the grille may define a contact surface adapted to the morphology of the area to be cleaned, of domed shape for example.

[0153] The grille may also have, where applicable, an adjustable effective diameter. The device may comprise a mechanical element of variable opening such as a diaphragm, disposed in front of or behind the grille, in such a way as to adjust the accessible diameter of the opening or openings. For example, the device comprises a diaphragm centred on the longitudinal axis of the transducer.

[0154] Some or all of the openings in the grille may be closed fully or partially in a controlled manner. This makes it possible, according to the area to be treated, and in particular for more sensitive areas such as areas around the eyes, to limit the surface area and the intensity of treatment, if desired. The device may comprise a shutter that is moveable between a position in which it does not cover one or more openings in the grille and a covering position in which the opening or openings are covered at least partially, or even fully. This shutter is for example adjusted manually by the user as needed.

[0155] Preferably, the grille has a thickness of between 0.1 and 10 mm, better still between 0.5 and 5 mm. This ensures a minimum distance of at least this thickness between the transducer and the keratin material, regardless of the position of the grille.

[0156] The grille is preferably formed of a rigid or semi-rigid material, for example metal, or rigid plastic. The grille is for example made of a material selected from a metal, notably steel, stainless steel, an alloy, silicone, a polymer, notably of polyurethane (PU), polyethylene terephthalate (PET) or polythiophene (PT) type, or a combination of multiple of these elements. The grille may also be made of rubber or latex.

[0157] According to one embodiment of the invention, the grille is a nonwoven, produced from natural or synthetic materials.

[0158] The grille may not deform visibly to the naked eye during normal use, owing to its rigidity. In a variant, the grille may be deformable. Its diameter may be reduced for example by applying mechanical pressure to its contour.

[0159] The grille may comprise recesses, notably extending in its thickness. The grille comprises deformable channels for example, the diameter of which may vary depending on the pressure applied, extending for example in a non-longitudinal direction. In a variant, the channels may be rigid to allow fluid to pass through even when pressure is applied to the grille.

[0160] The grille may also have reliefs or be flocked, or not.

[0161] The device may comprise an element for driving the grille, configured to generate a movement of oscillation, vibration and / or rotation of the grille on the keratin material. For example, the device comprises a motor for driving the grille in movement, for example rotary, linear, eccentric or the like, alternating or otherwise. The device may comprise a vibrator, where applicable, for vibrating the grille. The amplitude of the movement may be fixed or adjustable.

[0162] The grille may be produced in various ways.

[0163] The grille may comprise a peripheral frame, which defines the outer contour of the grille when seen face on. This frame may be rigid, in particular more rigid than a central part of the grille, which is perforated.

[0164] The contour of the grille, when seen face on, may have a circular, oval, polygonal or other shape, and preferably the grille has a closed contour.

[0165] The opening or openings in the grille may have substantially the same size. The grille may comprise a plurality of openings arranged in a regular grid, for example in rows or in columns.

[0166] In a variant, the opening or openings may be arranged concentrically.

[0167] The openings may have various shapes, in particular shapes of portions of disc(s) or ring(s).

[0168] The grille may have a single opening, in particular of non-circular contour, for example in the shape of a slot, cross, polygon, regular or non-regular, or oval. Preferably, the grille has at least two openings, in particular two openings of substantially the same size.

[0169] When there is a single opening, this may be centred or not.

[0170] A grille having a fine mesh improves the retention of the keratin surfaces to be treated during use of the device, which allows better control over a constant distance between said material and the support surface.

[0171] An opening in the grille may have an area of at least 1 mm2. A smaller dimension of an opening in the grille, when seen face on, is for example at least 0.5 mm2.Suction system

[0172] The suction system may be a micro-pump, a vacuum source for example, and any system capable of inducing air suction.

[0173] The device according to the invention may be in one piece or constitute a sub-part, for example a probe remote from a device. This sub-part may be to connect with a wire. A tube may provide energy and / or a negative / positive pressure.

[0174] The suction system may comprise at least one fan which is disposed at the inlet opening for the air to be drawn in and enables an increase or decrease in the inlet speed of the air flow, and / or means for adjusting the inlet flow rate of the air flow. These adjusting means may comprise a plunger equipped with a plain flap, with a butterfly valve, with a valve, with an iris or with a diaphragm, the position of which is adjusted to vary the air flow rate.

[0175] The suction system may be equipped with a suction valve which may enable a movement of the microneedle towards the target area only when the pressure value in the chamber reaches a threshold value.

[0176] Preferably, the pressure in the chamber is between 2 bar and 0.1 bar for carrying out the injection.

[0177] To carry out the injection, a vacuum level is reached in the pressure chamber. As it is mentioned here, a "vacuum level" is the absolute pressure below atmospheric pressure.

[0178] A vacuum level of 500 mmHg therefore corresponds to a pressure of 500 mmHg below atmospheric pressure.

[0179] When a vacuum level is considered to be greater than a given value, for example greater than 400 mmHg, the pressure inside the discharge chamber is an absolute pressure of a value lower than atmospheric pressure greater than said given value.

[0180] The means for controlling the vacuum is for example a controller and a detector, for detecting contact between the skin and the grille, in communication with said controller.

[0181] In one aspect, the control means is a mechanical control means.

[0182] The control means may further comprise a valve, said valve being able to be opened to relieve the vacuum by kinematic means.

[0183] According to one aspect, the means for generating a vacuum comprise at least one control valve, the controller being capable of delivering air through said at least one control valve in order to increase the pressure in the discharge chamber to atmospheric pressure following an injection, the control means being selected from the group of electronic means, pneumatic means, electrical means and optical means.

[0184] Preferably, the means for applying a vacuum comprise a vacuum pump and at least one control valve.

[0185] The inlet of air into the chamber during a mode for applying a vacuum may be prevented by means of a control valve and a control circuit or by means of manual obstruction of a vacuum chamber conduit.

[0186] Advantageously, the chamber has at least one suction opening, the vacuum being applied to the chamber via the suction opening.

[0187] In one aspect, the vacuum pump is an air pump.

[0188] In one aspect, the vacuum pump is a peristaltic pump, in order to draw air out of the interior of the vacuum chamber via a conduit in communication with the interior of the chamber.

[0189] In one aspect, the apparatus further comprises means for stabilizing the chamber on a substantially non-planar skin surface.

[0190] In one aspect, the apparatus further comprises a detector for detecting contact with the skin in order to detect the placement of the chamber on the target skin and in order to generate a signal to activate the vacuum pump after the chamber has been placed on the target skin.

[0191] Placement of the microneedles

[0192] In one aspect, the device further comprises a detector for detecting contact with the skin in order to detect the placement of the grille on the skin.

[0193] In one aspect, the device is adapted to discharge air from the chamber.

[0194] In one aspect, the device further comprises means for centring the microneedle with respect to and above an opening in the grille.

[0195] In one aspect, the device further comprises means for repositioning the chamber on another skin target without any spaces or overlap.

[0196] Driving of themicroneedles

[0197] Advantageously, the microneedle (or microneedles) is (are) placed on a plate.

[0198] The plate may be fastened by way of its opposite face to a stem connected to a drive mechanism configured to move the stem forwards when the microneedle has to be depressed into the skin.

[0199] The drive mechanism for the microneedles may comprise an electromechanical device such as an electric motor or a spring.

[0200] Usefully, the suction system and the drive mechanism comprise a sensor for sensing critical situations, such as the excessive suction of the skin, in order to interrupt the suction and the driving of the needle towards the skin.

[0201] Usefully, a device according to the invention comprises a housing in two parts, an upper part in the form of a handle for gripping and controlling the apparatus, and a lower part comprising the suction source and the microneedle which are necessary for the treatment.

[0202] The invention is not limited to a specific device for driving the stem and said stem may be driven in various ways, based for example on a pyrotechnic, pneumatic or hydraulic device, among others, or a manual force.

[0203] The stem is preferably of cylindrical shape with the same diameter as the microneedle and is centred with respect to the microneedles.

[0204] The end face of the stem preferably has a shape that is complementary to the shape of the end of the microneedle.

[0205] The end face of the stem may be planar and perpendicular to the longitudinal axis of the device.

[0206] The proximal end of the microneedle preferably has a corresponding planar surface, such that the contact surface between the stem and the microneedle is maximal.Preferred embodiments

[0207] Preferably, the device according to the invention has one or more of the following features, taken alone or in combination:

[0208] First embodiment of the device

[0209] The microneedle is moveable between a retracted position, in which the microneedle is spaced apart from the intermediate component by a maximum distance, and a depressed position, in which the microneedle is depressed into the target area of the skin to a maximum depth, the intermediate component being in contact with the target area of the skin in the retracted position and in the depressed position of the microneedle.

[0210] The microneedle is moved by a motor or by a mechanical action of a user, notably via a pushbutton or a spring.

[0211] The intermediate component is fastened to an edge of the suction opening.

[0212] The suction chamber has a dome shape.

[0213] The dome is mounted articulated to a conduit about an axis of articulation perpendicular to the axis of revolution of the dome, notably by a ball joint connection.

[0214] The conduit is engaged with an eccentric capable of causing it to pivot about the axis of articulation.

[0215] The microneedle is moveable towards the skin counter to an elastic return means, a movement of the microneedle towards the skin notably flipping a control switch for the suction source.

[0216] The microneedle is connected to a drive mechanism capable of moving the microneedle in the direction of the skin and in the direction away from the skin.

[0217] The intermediate component is elastically deformable.

[0218] The intermediate component is made of a solid material.

[0219] The intermediate component is removable.

[0220] The intermediate component is non-absorbent.

[0221] Second embodiment of the device

[0222] The needleless injection system comprises a reservoir of product connected to an injection head.

[0223] The needleless injection system comprises a first mechanism for releasing a product dose from a reservoir towards the injection head and a second mechanism for injecting the dose from the injection head towards the target area of skin.

[0224] The needleless injection system is moveable between a retracted position, in which the injection head is spaced apart from the intermediate component by a maximum distance, and a depressed position, in which the injection head is moved closer to the target area of the skin by a minimum distance, the intermediate component being in contact with the target area of the skin in the retracted position and in the depressed position of the injection head.

[0225] The injection head is moved by a motor.

[0226] The intermediate component is fastened to an edge of the suction opening.

[0227] The suction chamber has a dome shape.

[0228] The dome is mounted articulated to a conduit about an axis of articulation perpendicular to the axis of revolution of the dome, notably by a ball joint connection.

[0229] The conduit is engaged with an eccentric capable of causing it to pivot about the axis of articulation.

[0230] The injection head is moveable towards the skin counter to an elastic return means, a movement of the injection head towards the target area of skin flipping a control switch for the suction source.

[0231] The injection head is connected to a drive mechanism capable of moving the injection head in the direction of the skin and in the direction away from the target area of skin.

[0232] The intermediate component is elastically deformable.

[0233] The intermediate component is non-absorbent.

[0234] The intermediate component is made of a solid material.

[0235] The intermediate component is removable.

[0236] Description of the figures

[0237] Further features and advantages of the invention will become apparent from reading the following detailed description of non-limiting exemplary implementations thereof and from examining the appended drawing, in which:

[0238]

[0239] shows a longitudinal section of a first device according to the invention, with a suction chamber delimited by a dome,

[0240]

[0241] shows a longitudinal section of a second device according to the invention, comprising an articulated dome,

[0242]

[0243] shows a longitudinal section of the second device according to the invention, comprising the articulated dome with an inclination towards the right,

[0244]

[0245] shows a longitudinal section of a third device according to the invention, with a suction chamber delimited by a dome,

[0246]

[0247] shows a longitudinal section of a fourth device according to the invention, comprising an articulated dome,

[0248]

[0249] shows a longitudinal section of the fourth device according to the invention, comprising the articulated dome with an inclination towards the right.

[0250] Figures 1 to 3 illustrate embodiments of the device according to the invention with microneedles.

[0251] Figures 4 to 6 illustrate embodiments of the device according to the invention, with needleless injection.

[0252] The injection device 100 shown inis in a rest position. It comprises a suction chamber 1 delimited by a surface in the shape of a dome and a microneedle 6 housed in the suction chamber 1. In the example shown, the microneedle 6 is intended to be injected in its entirety into the stratum corneum, the epidermis or the dermis and is made of one or more materials selected depending on the desired action. For example, the microneedle 6 is made of hyaluronic acid or its derivatives.

[0253] The suction chamber 1 is delimited axially by a distal suction opening 2 coming into contact with the target area of the skin 3 and by a proximal suction opening 2 opening out into a suction conduit.

[0254] The device may comprise, where appropriate, around the distal suction opening 2, a sealing element such as a flexible lip 12 in order to contain the air and facilitate its return towards the tubular suction conduit 13. The lip 12 may be constituted of sub-lips between which the air can be recovered.

[0255] The conduit 13 may communicate with a suction pump, for example an electric pump, which may send the delivered air into a filter. Said filter may be arranged to stop, for example, the particles in suspension in the air, for instance skin debris removed during the suction.

[0256] The distal suction opening 2 is closed by a grille 7 in contact with the target area of skin 3 to be treated, comprising, for example, regular orifices 8 arranged in rows and in columns.

[0257] The position illustrated incorresponds to the one of maximum pulling of the skin caused by the suction, generating a suction effect. As can be seen in, the surface of the skin is planar and horizontal, due to the fact that the skin fold which would form under the suction effect in the absence of a grille 7 is limited by the grille 7 in the device according to the invention, thus increasing the quality of the injection.

[0258] The tubular conduit 13 serves to connect the suction chamber 1 to a pump intended to create a vacuum in the suction chamber 1. If desired, this same chamber 1 is connected to a venting conduit. Lastly, it may also be connected to a pressure regulator associated with a control button.

[0259] The microneedle 6 is mounted on a support surface 4 forming, for example, a distal end of a carriage 14 controlled by a drive motor (not shown) and being able to be moved up and down along the longitudinal axis X of the device as shown in the figures by the double arrows parallel to the axis X.

[0260] The device may comprise at least one pressure sensor and be configured to permit the injection only when a pressure threshold is exceeded on the skin.

[0261] This reduces the suppleness of the skin and improves the penetration of the microneedles 6 into the skin.

[0262] The injection device may comprise a processor controlling the drive mechanism used to move the carriage 14. This processor receives the signal from the pressure sensor and can trigger the injection only when a given pressure is reached.

[0263] In the example shown in, the device is in a rest position and the target area 3 is inclined. The dome is articulated by ball joints 9, in order to improve the positioning of the opening 2 on the skin and to follow the contour of the area 3 to be treated, notably for curved surfaces of the skin.

[0264] The angle α between the longitudinal axis X of the device and the target area of the skin 3 varies in particular between 10° for a maximum inclination of the longitudinal axis X and 90° when the axis X is perpendicular to the area. In the example shown in this figure, the angle α is around 80 degrees.

[0265] The microneedle 6 is moveable towards the skin counter to an elastic return means that may be associated with an on / off switch and with a microcontroller.

[0266] In the event that the force to puncture the skin were to become abnormal, the support surface 4 can be raised, thus increasing the spacing between the needle and the skin, thus limiting the depressing force of the needle. Thus, a spring 11 can act as a safety measure allowing the maximum depressing force to be limited to a determined value, thus limiting, or even eliminating, the risk of producing a haematoma.

[0267] When a pushbutton is present, it can have two functions, that of closing the circuit comprising the pump and the suction chamber 1 for example with the aid of a valve, and of actuating an electrical switch for turning on the suction.

[0268] In the example shown in, the device is in a rest position and the angle α is around 70°, the target area 3 being flat.

[0269] It is observed that, in a rest position and in an injection position, the grille 7 is in contact with the skin.

[0270] Figures 4 to 6 illustrate the second embodiment of the invention, with a needleless injection system.

[0271] The injection device 100 shown inis in a rest position. It comprises a suction chamber 1 delimited by a surface in the shape of a dome and a needleless injection system 22 housed in the suction chamber 1. The needleless injection system terminates, at its distal end, with an injection head 21 provided with an exit hole for the product 20.

[0272] The suction chamber 1 is delimited axially by a distal suction opening 2 coming into contact with the target area of the skin 3 and by a proximal suction opening 2 opening out into a suction conduit.

[0273] The device may comprise, where appropriate, around the distal suction opening 2, a sealing element such as a flexible lip 12 in order to contain the air and facilitate its return towards the tubular suction conduit 13. The lip 12 may be constituted of sub-lips between which the air can be recovered.

[0274] The conduit 13 may communicate with a suction pump, for example an electric pump, which may send the delivered air into a filter. Said filter may be arranged to stop, for example, the particles in suspension in the air, for instance skin debris removed during the suction.

[0275] The distal suction opening 2 is closed by a grille 7 in contact with the target area of skin 3 to be treated, comprising, for example, regular orifices 8 arranged in rows and in columns.

[0276] The position illustrated incorresponds to the one of maximum pulling of the skin caused by the suction, generating a suction effect. As can be seen in, the surface of the skin is planar and horizontal, due to the fact that the skin fold which would form under the suction effect in the absence of a grille 7 is limited by the grille 7 in the device according to the invention, thus increasing the quality of the injection.

[0277] The tubular conduit 13 serves to connect the suction chamber 1 to a pump intended to create a vacuum in the suction chamber 1. If desired, this same chamber 1 is connected to a venting conduit. Lastly, it may also be connected to a pressure regulator associated with a control button.

[0278] The injection head 21 may form a distal end of a carriage 14 controlled by a drive motor (not shown) and being able to be moved up and down along the longitudinal axis X of the device as shown in the figures by the double arrows parallel to the axis X.

[0279] The device 100 may comprise at least one pressure sensor and be configured to permit the injection only when a pressure threshold is exceeded on the skin.

[0280] This reduces the suppleness of the skin and improves the penetration of the microneedles 6 into the skin.

[0281] The injection device may comprise a processor controlling the drive mechanism used to move the carriage 14. This processor receives the signal from the pressure sensor and can trigger the injection only when a given pressure is reached.

[0282] In the example shown in, the device is in a rest position and the target area 3 is inclined. The dome is articulated by ball joints 9, in order to improve the positioning of the opening 2 on the skin and to follow the contour of the area 3 to be treated, notably for curved surfaces of the skin.

[0283] The angle α between the longitudinal axis X of the device and the target area of the skin 3 varies in particular between 10° for a maximum inclination of the longitudinal axis X and 90° when the axis X is perpendicular to the area. In the example shown in this figure, the angle α is around 80 degrees.

[0284] The microneedle 6 is moveable towards the skin counter to an elastic return means that may be associated with an on / off switch and with a microcontroller.

[0285] In the event that the force to puncture the skin were to become abnormal, the support surface 4 can be raised, thus increasing the spacing between the needle and the skin, thus limiting the depressing force of the needle. Thus, a spring 11 can act as a safety measure allowing the maximum depressing force to be limited to a determined value, thus limiting, or even eliminating, the risk of producing a haematoma.

[0286] When a pushbutton is present, it can have two functions, that of closing the circuit comprising the pump and the suction chamber 1 for example with the aid of a valve, and of actuating an electrical switch for turning on the suction.

[0287] In the example shown in, the device is in a rest position and the angle α is around 70°, the target area 3 being flat.

[0288] It is observed that, in a rest position and in an injection position, the grille 7 is in contact with the skin.

[0289] The invention is not limited to the embodiments shown in the figures. The device according to the invention may have a structure that differs from the one shown, for example concerning the drive mechanism.

Claims

Injection device (100) with needle for injecting a product, in particular a cosmetic product, the device comprising: a suction chamber (1) with a distal suction opening (2) configured to face a target body area (3) of the skin when the device is applied to the skin, a support surface (4) inside the chamber (1) at a position set back from the opening (2), and a suction source in communication with the chamber (1), in order to reduce the pressure in the chamber and bring about the suction of the target area (3) towards the chamber (1), the support surface (4) comprising at least one microneedle (6) for carrying out the injection, characterized in that the suction opening (2) is closed by an intermediate component (7), defining a contact surface with the target area (3), and having at least one orifice (8) designed to be passed through by at least part of the microneedle (6), when the target area (3) is suctioned towards the chamber (1).Injection device according to Claim 1, characterized in that the microneedle (6) is moveable between a retracted position, in which the microneedle (6) is spaced apart from the intermediate component (7) by a maximum distance, and a depressed position, in which the microneedle (6) is depressed into the target area (3) of the skin to a maximum depth, the intermediate component (7) being in contact with the target area (3) of the skin in the retracted position and in the depressed position of the microneedle (6).Injection device according to either one of the preceding claims, characterized in that the microneedle (6) is moved by a motor or by a mechanical action of a user, notably via a pushbutton or a spring.Injection device according to any one of the preceding claims, characterized in that the intermediate component (7) is fastened to an edge of the suction opening (2).Injection device according to any one of the preceding claims, characterized in that the suction chamber (1) has a dome shape.Device according to the preceding claim, characterized in that the dome is mounted articulated to a conduit about an axis of articulation perpendicular to the axis of revolution of the dome, notably by a ball joint connection (9).Device according to the preceding claim, characterized in that the conduit is engaged with an eccentric capable of causing it to pivot about the axis of articulation.Device according to any one of the preceding claims, characterized in that the microneedle (6) is moveable towards the skin counter to an elastic return means (11), a movement of the microneedle (6) towards the skin notably flipping a control switch for the suction source.Injection device according to any one of the preceding claims, characterized in that the microneedle (6) is connected to a drive mechanism capable of moving the microneedle (6) in the direction of the skin and in the direction away from the skin.Injection device according to any one of the preceding claims, characterized in that the intermediate component (7) is elastically deformable.Injection device according to any one of the preceding claims, characterized in that the intermediate component (7) is made of a solid material.Injection device according to any one of the preceding claims, characterized in that the intermediate component (7) is removable.Injection device according to any one of the preceding claims, characterized in that the intermediate component (7) is non-absorbent.Cosmetic injection process comprising the operations consisting in (i) providing a device according to any one of the preceding claims, (ii) positioning the intermediate component (7) in contact with a target area (3) of the skin; (iii) applying a vacuum of sufficient value to said target area (3) of the skin such that the latter is placed and compressed against the intermediate component (7); and (iv) carrying out the injection by causing the microneedle (6) to pass through the intermediate component (7) and by causing the microneedle (6) to penetrate the skin.

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