Injection device with micro-needle including a suction system

Abstract

The invention relates to a device (100) for injecting a product, particularly a cosmetic product, with a needle. The device comprises: a suction chamber (1), a support surface (4) inside the chamber (1) positioned recessed relative to the opening (2), and a suction source. The support surface (4) includes at least one micro-needle (6) for performing the injection. The suction opening (2) is closed by an intermediate piece (7), defining a contact surface with the target area (3), and having at least one orifice (8) designed to be traversed by the micro-needle (6) when the target area (3) is drawn into the chamber (1). Figure 1

Description

Title of the invention: Injection device with micro-needle comprising a suction system

[0001] The present invention relates to a device for subcutaneous injection of a product, in particular a cosmetic product, comprising a skin suction system. 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 a micro-needle.

[0003] In a second embodiment of the invention, the device is a needle-free 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 dated November 30, 2009, relating to cosmetic products. Technological background

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

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

[0007] The facial muscles then work closer to the skin's surface, so that smile lines 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) constitutes the main barrier of the epidermis to exogenous substances, including compositions of small and high molecular weight biopolymers used as cosmetic fillers.

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

[0012] The making 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] Substance administration into the skin can be technically difficult, especially when injecting at shallow depth, due to subject and environmental factors such as anatomy, age, location of the skin on the body, climate, skin condition, such as roughness or elasticity, these factors vary considerably from one injection to another. For example, the elasticity of the skin, bone or fat lead to non-standardized injection conditions. For shallow injection, the consequence can be high failure rates, which is problematic especially for devices intended for use in aesthetic clinics, retail outlets or, even worse, at home.

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

[0015] Document WO2020064085 discloses an injection device comprising:

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

[0017] a surface within the chamber at a position recessed from the opening, and

[0018] a pressure source in communication with the chamber, at least to decrease the pressure in the chamber and cause the targeted area to be drawn into the chamber and to contact the surface,

[0019] the surface comprising micro-needles for puncturing the skin of the targeted area.

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

[0021] Document WO2007 / 015247 discloses a device comprising:a) a chamber evacuation chamber comprising a substantially rigid interface member through which medical treatment can be delivered to a selected skin region, one or more walls that can be placed on or near said skin region, an interior defined by at least said one or more walls and by said interface member, and an opening at the bottom of said interior that can be sealed by said skin region; b) means for generating a vacuum within said evacuation chamber interior, the level of the applied vacuum being suitable for pulling said skin region through said opening toward, and in compressive relation against, said interface member, so as to inhibit the transmission of a pain signal generated by pain receptors located in said skin region;and c) means for administering a skin-related medical treatment, said administering means being adapted to pass through said interface element and to be directed towards said compressed, pain-inhibiting skin region.;

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

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

[0024] WO2004 / 004803 discloses an intradermal delivery device having a housing containing a syringe for injecting a substance to a predetermined insertion depth and a base assembly for tensioning a target area of ​​skin. One embodiment tensions the skin by vacuum pressure and another by expansion of a mounting surface in contact with the skin. Upon tensioning the target area, a needle extends into the target area to the insertion depth. At the insertion depth, a plunger depresses inside the syringe and delivers the substance through the needle. Upon completion of the injection, the needle retracts, the skin tension is released, and the intradermal delivery device is withdrawn. As shown in Figure 20, a needle is fixedly attached to one end of the syringe and is movable through the needle opening upon actuation of the syringe to inject a substance contained in the syringe into the substantially planar needle penetration region X of the skin.In a presently preferred embodiment of the present invention, the needle opening is large enough to allow the needle to pass therethrough. The needle opening is spaced from the skin.

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

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

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

[0028] There is a need to have the same penetration depth of all micro needles in the skin.

[0029] There is a need to have the same depth of penetration over the entire surface of the targeted / treated area.

[0030] Definition of the invention

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

[0032] The invention relates to a device for injecting a product, in particular a cosmetic product, with a needle, the device comprising: a suction chamber with a distal suction opening configured to face a targeted 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, to reduce the pressure in the chamber and cause the targeted area to be sucked into the chamber, the support surface comprising at least one micro-needle for carrying out the injection, the suction opening is closed by an intermediate part, defining a contact surface with the targeted area, and having at least one orifice designed to be crossed by at least part of the micro-needle, when the targeted area is sucked into the chamber.

[0033] Second embodiment of the invention: needle-free injection device

[0034] The invention relates to a needle-free injection device for a product, in particular a cosmetic product, comprising: a suction chamber with a distal suction opening configured to face a targeted area of ​​the skin when the device is applied to the skin, a needle-free injection system comprising an injection head provided with a product outlet hole located at a position set back from the opening, and a suction source in communication with the chamber, to reduce the pressure in the chamber and cause the targeted area to be sucked into the chamber, the suction opening is closed by an intermediate part, defining a contact surface with the targeted area, and having at least one orifice, through which the product is injected into the targeted area when the skin is sucked into the chamber.

[0035] The use of the device of the invention offers a lasting solution for the correction of the signs and disorders of skin aging, by improving the skin penetration of filling 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, act advantageously on the physical, mechanical and / or optical characteristics of the skin, both internally and externally, in particular on hydration, elasticity, volume flexibility, tone, firmness, luminosity, radiance uniformly over the targeted area, but also on the appearance of the surface of the targeted area, by improving its softness, relief, radiance and / or color.

[0037] The device according to the invention makes it possible to target and deliver uniformly into the skin layers liquid and / or gaseous or solid liquid compositions (suspensions) which are possibly resorbable and injectable, to correct, soften and / or erase the signs of skin aging, such as wrinkles, skin folds, in particular facial folds, skin depressions, changes in the oval of the face, in particular shallow contours, or the sagging of certain areas.

[0038] The appearance of certain indented scars, due for example to acne, the shape and volume of the cheekbones and the general loss of volume can also be corrected uniformly over the entire surface of the targeted 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 the shadow of the lower eyelids, reduce or correct dark circles.

[0040] The targeted skin area is drawn into the chamber to bring the targeted area into contact with the microneedle.

[0041] Thanks to the device according to the invention, it becomes possible to:

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

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

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

[0045] Allow a controlled injection angle,

[0046] Optionally, allow the repetitive insertion of the needle into the skin,

[0047] The invention described may be used for care or makeup applications. of keratinous surfaces.

[0048] The invention also relates to a cosmetic injection method comprising the operations consisting of (i) providing a device as defined above according to the first embodiment of the invention, (ii) positioning the intermediate piece in contact with a targeted area of ​​the skin; (iii) applying a vacuum of sufficient value to said targeted area of ​​the skin so that the latter is pressed and compressed against the intermediate piece; and c) carrying out the injection by passing the micro-needle through the intermediate piece and by making the micro-needle penetrate into the skin.

[0049] The invention also relates to a cosmetic injection method comprising the operations consisting of (i) providing a device as defined above, (ii) positioning the intermediate part in contact with a targeted area of ​​the skin; (iii) applying a vacuum of sufficient value to said targeted area of ​​the skin so that the latter is pressed and compressed against the intermediate part; and c) carrying out the injection by passing the cosmetic product emitted by the needle-free injection system through the intermediate part.

[0050] Device with micro-needles

[0051] The microneedles used according to the invention are known in the art. The microneedles can be of any type.

[0052] A gas can be injected by the microneedles, before or after delivery of the composition, particularly cosmetic, such as CO2, O2, N2, CO2, 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 Tuesday 2004, Pages 581-587, "Biodegradable polymer microneedles: Fabrication, mechanics and transdermal drug delivery", Journal of Controlled Release, Volume 104, Number 1, May 5, 2005, Pages 51-66, " Microfabricated Needles for Transdermal Delivery of Macromolecules and Nanoparticles: Fabrication Methods and Transport Studies, Transport Studies," Devin V. McAllister et al, PNAS, November 25, 2003.

[0054] The hollow microneedles may have at least one internal channel.

[0055] Such a channel may be longitudinal, i.e. extending along a longitudinal axis of the micro-needles, from their free ends to the base of the device, or transverse, i.e. extending along an axis extending obliquely or perpendicularly to the longitudinal axis of the micro-needles.

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

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

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

[0059] Alternatively, 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 loaded with said at least one composition aimed at generating an in-situ reaction in the skin, scalp or lips.

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

[0062] Microneedles can be absorbable.

[0063] By "resorbable" or "bioresorbable, or naturally dissolving microneedles", it is meant 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] Microneedles may be bioabsorbable or biodegradable.

[0065] Microneedles can dissolve or degrade through 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 requiring no mechanical removal.

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

[0068] Alternatively, the absorbable microneedles may swell in the skin, scalp or lips, i.e., may increase in volume when injected into the skin, scalp or lips.

[0069] In the case of absorbable microneedles, at least a portion of the material from which the microneedles are made can be used, once injected into the skin, scalp or lips, as a cosmetic filler.

[0070] Alternatively, the microneedles are non-absorbable.

[0071] By "non-absorbable microneedles" it is meant that the microneedles do not dissolve or degrade in vivo, and must be removed from the skin.

[0072] Microneedles may not swell in moisture.

[0073] A length of each microneedle is preferably less than or equal to 50 mm, better than 20 mm, better than 5 mm, better than 1 mm, better than 0.3 mm, even better than 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 micro-needle” designates an axis passing through the barycenters of the cross-sections of the micro-needle.

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

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

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

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

[0080] The largest internal transverse dimension of the microneedles can be chosen according to 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 chosen according to the targeted skin layer in which the composition is to be delivered, obtaining the appropriate depth in the skin.

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

[0084] In an alternative embodiment, the microneedles are oriented obliquely relative to the substantially flat surface along which the base extends.

[0085] This allows the composition to be delivered onto curved surfaces with microneedles oriented locally perpendicularly.

[0086] The microneedles may have a curved shape.

[0087] The microneedles may be of non-cylindrical shape, in particular pyramidal with an octagonal base, and have a variable diameter along 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 leads to very high reliability for silicon microneedles during penetration.

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

[0090] The microneedles may be made of an inorganic material, preferably silicon, titanium, stainless steel, cobalt, ceramic, polyethylene or any material that can be implanted into the skin and / or the body.

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

[0092] Alternatively, 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 carrying light and / or heat and / or cold.

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

[0095] The microneedles are preferably single-use.

[0096] The device may consist of several bases connected together 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 to 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 thereunder and a guide track substantially perpendicular to said bar.

[0099] Needle-free device

[0100] Needle-free injection devices work by creating, for example by means of a piston moving in a reservoir, a jet of fluid or powder under very high pressure which penetrates the skin.

[0101] The profile of the force exerted by the piston can be broken down into a first phase of short duration where the intensity of the force must be high for the jet to reach a speed allowing it to pierce the skin and a second longer phase of less duration and / or intensity which injects the desired quantity at the desired depth.

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

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

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

[0105] Device, 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 carrying one or more microneedles, preferably integral therewith, and a flexible support to which the bases are attached so that the bases can move relative to each other to conform to the profile of the skin.

[0108] The device may consist of several bases connected together to one or more containers containing a composition to be injected.

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

[0110] The containers can be refillable while remaining connected to a microneedle network.

[0111] The base can carry between 2 and 1000 microneedles per cm2, better between 15 and 50 microneedles.

[0112] The number of micro-needles per base advantageously depends on the targeted 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 depends on the size of the area of ​​skin to be treated.

[0114] The device may be able to cause the microneedles to puncture the skin at a deep level and then dispense the composition while removing the device.

[0115] This allows for a good distribution of the composition in the different layers of the skin.

[0116] The microneedles can be arranged regularly on the base or not.

[0117] Alternatively, the microneedles are arranged in an irregular manner on the base.

[0118] The base may carry only absorbable microneedles, or only non-absorbable microneedles.

[0119] Alternatively, the base carries a mixture of absorbable and non-absorbable microneedles.

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

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

[0122] The device may be connected by wireless communication to an electronic system, in particular a personal computer or a smartphone, for injection control.

[0123] Alternatively, the device comprises an electronic system.

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

[0125] This makes it possible to obtain great precision and to avoid errors, in particular by preventing the risks of excess composition and overflow beyond the area to be filled.

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

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

[0128] Cold can help to locally anesthetize the area to be injected.

[0129] An application, particularly one running on a smartphone, may be used for delivery control and user interface.

[0130] The device may be part of a watch connected to a smartphone, or to a remote device connected wired or wirelessly, for example by radio frequency, WIFI or Bluetooth®.

[0131] The device may include a vibrating system for inducing vibrations in the microneedles.

[0132] The vibrating system can also provide a massage to the treated area, allowing better diffusion of the composition.

[0133] According to one embodiment of the invention, the device may comprise a non-woven fabric soaked in a composition, to carry out the needle coating just before its skin penetration. The composition may be a disinfectant lotion or a composition with an active molecule to induce their penetration.

[0134] The device may include an optical detection system for synchronizing the movement of the injection system and the movement of the grid, in particular for properly positioning the needle relative to the orifices of the grid.

[0135] The device may further include an optical detection / diagnostic system to assess the condition of the skin and validate it prior to injection.

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

[0137] The device may further include an interface for data collection or analysis.

[0138] The device may further include an on-board light source to facilitate locating the injection site on top of the skin.

[0139] The device may further include pressure elements, possibly rotatable, to compress the skin on two lateral sides, allowing the creation of a skin roll / bulge / bump to facilitate injection and normalize the biomechanical properties of the skin.

[0140] Grid

[0141] The intermediate part may in particular be a grid, a wall, a surface.

[0142] According to an advantageous embodiment of the device according to the invention, the part in intermediate piece is not in contact with the targeted area of ​​the skin in the retracted position; the suction allowing this contact to be established before the pushing position, if the distance between the skin and the intermediate piece is sufficiently small.

[0143] A grid is an intermediate part that can be envisaged according to the invention.

[0144] In particular, the grid may be a porous wall, a membrane, a non-woven fabric, a septum allowing the skin to be pressed against the porous wall / membrane under the effect of suction.

[0145] The grid is preferably non-absorbent, i.e. it is not porous.

[0146] The grid may in particular not have the capacity to soak up water when immersed in water, and retain for example less than 10% of water, better still less than 5% of its water weight, even better still less than 0.5%.

[0147] The grid can in particular be made of a solid material. The grid can be a foam, a fabric or a felt, a membrane, made of polyurethane for example.

[0148] The contact surface of the device with the keratin materials can be defined by a non-absorbent surface of the grid.

[0149] The region of the grid defining the openings thereof may be defined by a non-absorbent portion of the grid.

[0150] The grid is preferably removable, that is to say it can be easily detached by the user of the device, preferably without using a tool. This facilitates cleaning and allows it to be replaced between uses, or, if desired, to interchange several grids depending on the use, for example by choosing the type of grid best suited to the morphology of the area to be cleaned.

[0151] The contact surface defined by the grid may be substantially flat, in order to example of maintaining a substantially constant distance between the transducer and the keratin materials to be cleaned located opposite the surface of emission of the acoustic waves.

[0152] Alternatively, the grid may define a contact surface adapted to the morphology of the area to be cleaned, for example of a curved shape.

[0153] The grid may further have, where appropriate, an adjustable effective diameter. The device may comprise a variable aperture mechanical element such as a diaphragm, arranged in front of or behind the grid, so as to adjust the accessible diameter of the opening(s). For example, the device comprises a diaphragm centered on the longitudinal axis of the transducer.

[0154] Some or all of the openings of the grid can be closed in whole or in part in a controlled manner. This makes it possible, depending on the area to be treated, and in particular for more sensitive areas such as those located in the vicinity of the eyes, to limit the surface area and intensity of treatment, if desired. The device may comprise a shutter movable between a position of non-occultation of one or more openings of the grid and a occultation position where the opening(s) are occulted at least partially, or even totally. This shutter is for example adjusted manually by the user as required.

[0155] Preferably, the grid has a thickness of between 0.1 and 10 mm, better still between 0.5 and 5 mm. Thus, a minimum distance of at least this thickness is ensured between the transducer and the keratin materials, whatever the position of the grid.

[0156] The grid is preferably formed from a rigid or semi-rigid material, for example metal, or rigid plastic. The grid is for example made from a material chosen from a metal, in particular steel, stainless steel, an alloy, silicone, a polymer, in particular of the polyurethane (PU), polyethylene terephthalate (PET) or polythiophene (PT) type, or a combination of several of these elements. The grid can also be made of rubber or latex.

[0157] According to one embodiment of the invention, the grid is a non-woven fabric, made from natural or synthetic materials.

[0158] The grid may not deform visibly to the naked eye during normal use, due to its rigidity. Alternatively, the grid may be deformable. For example, its diameter may be reduced by applying mechanical pressure to its contour.

[0159] The grid may comprise recesses, in particular extending along its thickness. The grid comprises, for example, deformable channels, the diameter of which may vary according to the pressure applied, extending for example in a non-longitudinal direction. Alternatively, the channels may be rigid in order to allow the passage of fluid even if pressure is applied to the grid.

[0160] The grid may still have reliefs or be flocked, or not.

[0161] The device may comprise a grid drive element configured to generate an oscillating, vibrating and / or rotating movement of the grid to the keratin materials. For example, the device comprises a motor for driving the grid in movement, for example rotary, linear, eccentric or other, reciprocating or not. The device may comprise a vibrator, if appropriate, to vibrate the grid. The amplitude of the movement may be fixed or adjustable.

[0162] The grid can be made in different ways.

[0163] The grid may comprise a peripheral frame, which defines the outer contour of the grid in front view. This frame may be rigid, in particular more rigid than a central part of the grid, openwork.

[0164] The outline of the grid, in front view, may be circular, oval, polygonal or other in shape, and preferably the grid has a closed outline.

[0165] The opening(s) of the grid may be substantially the same size. The grid may comprise a plurality of openings arranged in a regular array, for example in rows or columns.

[0166] Alternatively, the opening(s) may be arranged concentrically.

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

[0168] The grid may have a single opening, in particular of non-circular outline, for example in the form of a slot, a cross, a polygon, regular or not, or an oval. Preferably, the grid has at least two openings, in particular two openings having substantially the same size.

[0169] In the presence of a single opening, this may or may not be centered.

[0170] A grid having a fine mesh improves the maintenance of keratin surfaces at treat when using the device, which allows better control of a constant distance between said materials and the support surface.

[0171] An opening of the grid may have an area of ​​at least 1mm2. A smallest dimension of an opening of the grid, in front view, is for example at least 0.5mm2. Suction system

[0172] The suction system can be a micro-pump, a vacuum source for example, as well as any system capable of inducing air depression.

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

[0174] The suction system may comprise at least one fan arranged at the level of the intake opening of the air to be sucked and making it possible to increase or decrease the airflow intake speed and / or means for regulating the airflow intake rate. These regulating means may comprise a piston equipped with a simple flap, a butterfly flap, a valve, an iris, a diaphragm whose position is regulated to vary the airflow rate.

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

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

[0177] To achieve the injection, a vacuum level is achieved in the pressure chamber. As referred to herein, 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, e.g. greater than 400 mmHg, the pressure inside the evacuation chamber is an absolute pressure of a value less than atmospheric pressure greater than said given value.

[0180] The vacuum control means is for example a controller and a skin contact detector with the grid 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 release the vacuum by kinematic means.

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

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

[0185] Air entry into the chamber during a vacuum application mode may be prevented by means of a control valve and control circuit or by means of manual occlusion 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, for drawing air from inside the vacuum chamber via a conduit communicating 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 includes a skin contact detector for detecting placement of the chamber on the target skin and for generating a signal to activate the vacuum pump after placement of the chamber on the target skin.

[0191] Placement of microneedles

[0192] In one aspect, the device further comprises a skin contact detector for detecting placement of the grid on the skin.

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

[0194] In one aspect, the device further comprises means for centering the micro needle relative to and above an opening in the grid.

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

[0196] Microneedle training

[0197] Advantageously, the micro-needle(s) is placed on a plate.

[0198] The plate may be attached by its opposite face to a rod connected to a drive mechanism configured to advance the rod when the microneedle is to be inserted into the skin.

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

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

[0201] Usefully, a device according to the invention comprises a two-part housing, an upper part in the form of a handle to allow the apparatus to be grasped and controlled, and a lower part comprising the suction source and the micro-needle necessary for the treatment.

[0202] The invention is not limited to a specific device for driving the rod and the latter can be driven in various ways, for example using a pyrotechnic, pneumatic or hydraulic device, among others, or manual force.

[0203] The rod is preferably cylindrical in shape with the same diameter as the microneedle and is centered relative to the microneedles.

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

[0205] The end face of the rod 31 may be flat and perpendicular to the longitudinal axis of the device.

[0206] The proximal end of the microneedle preferably has a corresponding flat surface, so that the contact surface between the shaft and the microneedle is maximized. Preferred embodiments

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

[0208] First embodiment of the device

[0209] The microneedle is movable between a retracted position, in which the microneedle is spaced from the intermediate piece by a maximum distance, and a driving position, in which the microneedle is driven into the targeted area of ​​the skin to a maximum depth, the intermediate piece being in contact with the targeted area of ​​the skin in the retracted position and in the driving position of the microneedle.

[0210] The micro-needle is set in motion by a motor or by a mechanical action of a user, in particular via a push button or a spring.

[0211] The intermediate piece is fixed to one edge of the suction opening.

[0212] The suction chamber has a bell shape.

[0213] The bell is mounted articulated to a conduit around an articulation axis perpendicular to the axis of revolution of the bell, in particular by a ball joint.

[0214] The conduit is engaged with an eccentric capable of pivoting it around the articulation axis.

[0215] The micro-needle is movable towards the skin against an elastic return means, a movement of the micro-needle towards the skin notably switching a suction source control switch.

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

[0217] The intermediate piece is elastically deformable.

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

[0219] The intermediate piece is removable.

[0220] The intermediate piece is non-absorbent.

[0221] Second embodiment of the device

[0222] The needle-free injection system comprises a product reservoir connected to an injection head.

[0223] The needle-free injection system comprises a first mechanism for releasing a dose of product from a reservoir to the injection head and a second mechanism for injecting the dose from the injection head to the targeted area of ​​skin.

[0224] The needleless injection system is movable between a retracted position, in which the injection head is spaced from the intermediate piece by a distance maximum and a pushing position, in which the injection head is brought closer to the targeted area of ​​the skin by a minimum distance, the intermediate piece being in contact with the targeted area of ​​the skin in the retracted position and in the pushing position of the injection head.

[0225] The injection head is set in motion by a motor.

[0226] The intermediate piece is fixed to one edge of the suction opening.

[0227] The suction chamber has a bell shape.

[0228] The bell is mounted articulated to a conduit around an articulation axis perpendicular to the axis of revolution of the bell, in particular by a ball joint.

[0229] The conduit is engaged with an eccentric capable of pivoting it around the articulation axis.

[0230] The injection head is movable towards the skin against an elastic return means, a movement of the injection head towards the targeted area of ​​skin toggling a suction source control switch.

[0231] The injection head is connected to a drive mechanism capable of moving the injection head towards the skin and away from the targeted area of ​​skin.

[0232] The intermediate piece is elastically deformable.

[0233] The intermediate piece is non-absorbent.

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

[0235] The intermediate piece is removable. Description of figures

[0236] Other characteristics and advantages of the invention will emerge from reading the detailed description which follows, from non-limiting examples of implementation thereof, and from examining the appended drawing, in which:

[0237] [Fig.l]

[0238] [Fig.l] represents a longitudinal section of a first device according to the invention, with a suction chamber delimited by a bell,

[0239] [Fig.2]

[0240] [Fig.2] represents a longitudinal section of a second device according to the invention, comprising an articulated bell,

[0241] [Fig.3]

[0242] [Fig.3] represents a longitudinal section of the second device according to the invention, comprising the articulated bell with an inclination towards the right.

[0243] [Fig.4]

[0244] [Fig.4] represents a longitudinal section of a third device according to the invention, with a suction chamber delimited by a bell,

[0245] [Fig.5]

[0246] [Fig.5] represents a longitudinal section of a fourth device according to the invention, comprising an articulated bell,

[0247] [Fig.6]

[0248] [Fig.6] represents a longitudinal section of the fourth device according to the invention, comprising the articulated bell with an inclination towards the right.

[0249] Figures 1 to 3 illustrate embodiments of the device according to the invention with micro-needles.

[0250] Figures 4 to 6 illustrate embodiments of the device according to the invention, with needle-free injection.

[0251] The injection device 100 shown in [Fig. 1] is in the rest position. It comprises a suction chamber 1 delimited by a bell-shaped surface and a micro-needle 6 housed in the suction chamber 1. In the example shown, the micro-needle 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 chosen according to the desired action. For example, the micro-needle 6 is made of hyaluronic acid or its derivatives.

[0252] The suction chamber 1 is axially delimited by a distal suction opening 2 coming into contact with the targeted area of ​​the skin 3 and by a proximal suction opening 2 opening into a suction duct.

[0253] The device may comprise, where appropriate, around the distal suction opening 2, a sealing element such as a flexible lip 12 to contain the air and facilitate its return to the tubular suction conduit 13. The lip 12 may consist of sub-lips between which air can be recovered.

[0254] The conduit 13 can communicate with a suction pump, for example an electric pump, which can send the discharged air into a filter. The latter can be arranged to stop, for example, particles suspended in the air, such as skin debris removed during suction, for example.

[0255] The distal suction opening 2 is closed by a grid 7 in contact with the targeted area of ​​skin 3 to be treated, comprising for example regular orifices 8 arranged in rows and columns.

[0256] The position illustrated by [Fig.l] corresponds to that of maximum pulling of the skin caused by the suction, generating a suction effect. As can be seen in [Fig.l], the surface of the skin is flat, horizontal, due to the fact that the skin fold, which would be formed by the suction effect in the absence of a grid 7, is limited by the grid 7 in the device according to the invention, which increases the quality of the injection.

[0257] The tubular conduit 13 is used 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 vent conduit. Finally, it can also be connected to a pressure regulator associated with a control button.

[0258] The micro-needle 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 capable of rising and falling along the longitudinal axis X of the device as shown in the figures by the double arrows parallel to the axis X.

[0259] The device may comprise at least one pressure sensor and be configured to only authorize injection when a pressure threshold is exceeded on the skin.

[0260] This makes it possible to reduce the flexibility of the skin and to improve the penetration of the microneedles 6 into the skin.

[0261] 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 only trigger the injection when a given pressure is reached.

[0262] In the example shown in [Fig.2], the device is in the rest position and the targeted area 3 is inclined. The bell is articulated by ball joints 9, to improve the positioning of the opening 2 on the skin and follow the curve of the area 3 to be treated, in particular for curved surfaces of the skin.

[0263] The angle α between the longitudinal axis X of the device and the targeted 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 approximately 80 degrees.

[0264] The micro-needle 6 is movable towards the skin against an elastic return means which can be associated with an on / off switch and a microcontroller.

[0265] In the event that the effort to puncture the skin becomes abnormal, the support surface 4 can lift, thus increasing the distance between the needle and the skin, thus limiting the force with which the needle is driven. As a result, a spring 11 can act as a safety device to limit the maximum driving force to a determined value, which limits, or even eliminates, the risk of producing a hematoma.

[0266] When present, a push button can have two functions, that of closing the circuit comprising the pump and the suction chamber 1 for example using a valve and of actuating an electric switch for starting the suction.

[0267] In the example shown in [Fig.3], the device is in the rest position and the angle a is approximately 70°, the targeted area 3 being flat.

[0268] It is observed that in the rest position and in the injection position, the grid 7 is in contact with the skin.

[0269] Figures 4 to 6 illustrate the second embodiment of the invention, with a needle-free injection system.

[0270] The injection device 100 shown in [Fig.4] is in the rest position. It comprises a suction chamber 1 delimited by a bell-shaped surface and a needle-free injection system 22 housed in the suction chamber 1. The needle-free injection system terminates, at its distal end, in an injection head 21 provided with a product outlet hole 20.

[0271] The suction chamber 1 is axially delimited by a distal suction opening 2 coming into contact with the targeted area of ​​the skin 3 and by a proximal suction opening 2 opening into a suction duct.

[0272] The device may comprise, where appropriate, around the distal suction opening 2, a sealing element such as a flexible lip 12 to contain the air and facilitate its return to the tubular suction conduit 13. The lip 12 may consist of sub-lips between which air can be recovered.

[0273] The conduit 13 can communicate with a suction pump, for example an electric pump, which can send the discharged air into a filter. The latter can be arranged to stop, for example, particles suspended in the air, such as skin debris removed during suction, for example.

[0274] The distal suction opening 2 is closed by a grid 7 in contact with the targeted area of ​​skin 3 to be treated, comprising for example regular orifices 8 arranged in rows and columns.

[0275] The position illustrated by [Fig.4] corresponds to that of maximum pulling of the skin caused by the suction, generating a suction effect. As can be seen in [Fig.4], the surface of the skin is flat, horizontal, due to the fact that the skin fold, which would be formed by the suction effect in the absence of a grid 7, is limited by the grid 7 in the device according to the invention, which increases the quality of the injection.

[0276] The tubular conduit 13 is used 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 vent conduit. Finally, it can also be connected to a pressure regulator associated with a control button.

[0277] The injection head 21 can form a distal end of a carriage 14 controlled by a drive motor not shown and capable of rising and falling along the longitudinal axis X of the device as shown in the figures by the double arrows parallel to the axis X.

[0278] The device 100 may comprise at least one pressure sensor and be configured to only authorize injection when a pressure threshold is exceeded on the skin.

[0279] This reduces the flexibility of the skin and improves the penetration of the microneedles 6 into the skin.

[0280] 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 only trigger the injection when a given pressure is reached. achievement.

[0281] In the example shown in [Fig.5], the device is in the rest position and the targeted area 3 is inclined. The bell is articulated by ball joints 9, to improve the positioning of the opening 2 on the skin and follow the curve of the area 3 to be treated, in particular for curved surfaces of the skin.

[0282] The angle α between the longitudinal axis X of the device and the targeted 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 approximately 80 degrees.

[0283] The micro-needle 6 is movable towards the skin against an elastic return means which can be associated with an on / off switch and a microcontroller.

[0284] In the event that the effort to puncture the skin becomes abnormal, the support surface 4 can lift, thus increasing the distance between the needle and the skin, thus limiting the force with which the needle is driven. As a result, a spring 11 can act as a safety device to limit the maximum driving force to a determined value, which limits, or even eliminates, the risk of producing a hematoma.

[0285] When present, a push button can have two functions, that of closing the circuit comprising the pump and the suction chamber 1 for example using a valve and of actuating an electric switch for starting the suction.

[0286] In the example shown in [Fig.6], the device is in the rest position and the angle a is approximately 70°, the targeted area 3 being flat.

[0287] It is observed that in the rest position and in the injection position, the grid 7 is in contact with the skin.

[0288] The invention is not limited to the embodiments shown in the figures. The device according to the invention may have a structure different from that shown, for example concerning the drive mechanism.

Claims

Claims

1. Device (100) for injecting with a needle a product, in particular a cosmetic product, the device comprising: a suction chamber (1) with a distal suction opening (2) configured to face a targeted 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), to reduce the pressure in the chamber and cause the targeted area (3) to be sucked towards the chamber (1), the support surface (4) comprising at least one micro-needle (6) for carrying out the injection, characterized in that the suction opening (2) is closed by an intermediate piece (7), defining a contact surface with the targeted area (3), and having at least one orifice (8) designed to be crossed by at least a part of the micro-needle (6),when the targeted area (3) is sucked towards the chamber (1).,

2. Injection device according to claim 1, characterized in that the micro-needle (6) is movable between a retracted position, in which the micro-needle (6) is spaced from the intermediate piece (7) by a maximum distance and a driving position, in which the micro-needle (6) is driven into the targeted area (3) of the skin to a maximum depth, the intermediate piece (7) being in contact with the targeted area (3) of the skin in the retracted position and in the driving position of the micro-needle (6).

3. Injection device according to any one of the preceding claims, characterized in that the micro-needle (6) is set in motion by a motor or by a mechanical action of a user, in particular via a push button or a spring.

4. Injection device according to any one of the preceding claims, characterized in that the intermediate piece (7) is fixed to an edge of the suction opening (2).

5. Injection device according to any one of the preceding claims, characterized in that the suction chamber (1) has a bell shape.

6. Device according to the preceding claim, characterized in that the bell is mounted articulated to a conduit around an articulation axis perpendicular to the axis of revolution of the bell, in particular by a ball joint (9).

7. Device according to the preceding claim, characterized in that the conduit is engaged with an eccentric capable of making it pivot around the articulation axis.

8. Device according to any one of the preceding claims, characterized in that the micro-needle (6) is movable towards the skin against an elastic return means (11), a movement of the micro-needle (6) towards the skin tilting in particular a switch for controlling the suction source.

9. Injection device according to any one of the preceding claims, characterized in that the micro-needle (6) is connected to a drive mechanism capable of moving the micro-needle (6) towards the skin and in the direction away from the skin.

10. Injection device according to any one of the preceding claims, characterized in that the intermediate part (7) is elastically deformable.

11. Injection device according to any one of the preceding claims, characterized in that the intermediate part (7) is made of a solid material.

12. Injection device according to any one of the preceding claims, characterized in that the intermediate part (7) is removable.

13. Injection device according to any one of the preceding claims, characterized in that the intermediate part (7) is non-absorbent.

14. A cosmetic injection method comprising the operations of (i) providing a device according to any one of the preceding claims, (ii) positioning the intermediate piece (7) in contact with a targeted area (3) of the skin; (iii) applying a vacuum of sufficient value to said targeted area (3) of the skin so that the latter is pressed and compressed against the intermediate piece (7); and c) carrying out the injection by passing the microneedle (6) through the intermediate piece (7) and by penetrating the microneedle (6) into the skin.

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