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WO2024208607A1 - Dispositif de carboxythérapie à micro-aiguille creuse - Google Patents

Dispositif de carboxythérapie à micro-aiguille creuse Download PDF

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Publication number
WO2024208607A1
WO2024208607A1 PCT/EP2024/057729 EP2024057729W WO2024208607A1 WO 2024208607 A1 WO2024208607 A1 WO 2024208607A1 EP 2024057729 W EP2024057729 W EP 2024057729W WO 2024208607 A1 WO2024208607 A1 WO 2024208607A1
Authority
WO
WIPO (PCT)
Prior art keywords
microneedle
gas
injection
skin
purge system
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2024/057729
Other languages
English (en)
Inventor
Woo Ram Park
Charlotte PELLET
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
LOreal SA
Original Assignee
LOreal SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by LOreal SA filed Critical LOreal SA
Priority to KR1020257036975A priority Critical patent/KR20250162937A/ko
Priority to CN202480024195.5A priority patent/CN121038843A/zh
Publication of WO2024208607A1 publication Critical patent/WO2024208607A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M35/00—Devices for applying media, e.g. remedies, on the human body
    • A61M35/30—Gas therapy for therapeutic treatment of the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0061—Methods for using microneedles

Definitions

  • the present invention relates to a device, in particular a cosmetic device, for injecting gas under the skin, in particular carbon dioxide, said device comprising a hollow microneedle. It also relates to a cosmetic method using this device.
  • the gases that can be injected according to the invention are chosen in particular from biocompatible gases such as CO2, N2O, NO, O2, H2.
  • the gas injected according to the invention is CO2.
  • a cosmetic product is a product as defined in Regulation EC No. 1223/2009 of the European Parliament and of the Council dated 30 November 2009, relating to cosmetic products.
  • the facial skin also stretches a little, adding a loss of facial volume.
  • the stratum corneum is the main barrier of the epidermis to exogenous substances, including the low and high weight molecular biopolymer compositions used as cosmetic fillers.
  • Thin cutaneous tissue is most probably the main reason for darker skin around the eyes. This fine skin reveals the underlying veins and capillaries, giving the area a bluish, even purplish, or greyish colour. This colouring is aggravated in cases of vascular congestion and lack of oxygenation in the periorbital zone. In addition, as the skin ages, the lipid layer under the eyes sags and swells, creating shadows and thus making this area even darker. A second common cause is excessive pigmentation of the skin, whether spontaneous or induced by the environment.
  • the challenge lies in achieving overall management of dark circles, including improving the skin colouration, for which injections (of hyaluronic acid for example) alone have not demonstrated efficacy.
  • Laser treatment and chemical peels exist but are generally very aggressive and accompanied by significant adverse effects.
  • Carboxytherapy involves subcutaneous injection of carbon dioxide (CO2), very often targeting the dermis or hypodermis.
  • CO2 carbon dioxide
  • the injected CO2 creates hypercapnic stress, which increases transcutaneous oxygen pressure (tc-PCh) through three phenomena: an increase in capillary blood flow; a reduction in cutaneous oxygen consumption caused by the vasodilator effect of CO2; the Bohr effect, or the increased dissociation of oxygen from haemoglobin in the presence of carbon dioxide.
  • Injection of CO2 affords many benefits: oxygenation, improvement of the microcirculation, collagen stimulation, anti-inflammatory properties.
  • the cosmetic advantages observed clinically are the improvement in the pigmentation of the rings under the eyes, and the brightening of the eye contour.
  • the gas advantageously acts on the physical, mechanical and/or optical characteristics of the skin, in particular of the dark circles, inside and outside, in particular on the elasticity, volume flexibility, tonicity, firmness, brightness and radiance, but also on the appearance of the skin surface, improving its softness, its relief, its radiance and/or its colour.
  • the document WO2014142970 discloses a method and an apparatus for applying carb oxy therapy to a person.
  • the method includes the steps of: bringing a target body surface of the subject into contact with a treatment device comprising a plurality of hollow needles attached to a contact surface of a housing, and a CO2 source in fluidic communication with at least one of the plurality of hollow needles; applying pressure to the housing such that one or more of the plurality of hollow needles penetrate an epidermis or an outer layer of cells in the target body surface; applying a therapeutic amount of CO2 to the subject through said plurality of hollow needles; and removing the plurality of hollow needles from the target body surface.
  • the needles have a length of approximately 0.1 mm, 0.15 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 6.0 mm, 7.0 mm, 8.0 mm, 9.0 mm or 10.0 mm. It is also stated that the needle lengths can control the depth levels and therefore the exact location where the treatment fluid will be administered.
  • the invention relates to a device, in particular a cosmetic device, for the subcutaneous injection of gas, in particular carbon dioxide (CO2), comprising a gas reservoir in fluidic communication with a hollow microneedle via a distribution line. It comprises a purge system for evacuating residual gases present in the microneedle.
  • gas in particular carbon dioxide (CO2)
  • CO2 carbon dioxide
  • 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 possible fillers.
  • the composition is delivered deeper into the skin, bypassing the SC layer.
  • the invention also relates to a method for subcutaneous injection of gas, in particular carbon dioxide (CO2), comprising (i) the use of a device as defined above, and (ii) the injection of the gas for a period of between 1 second and 15 seconds with a flow rate of between 20 ml/min and 60 ml/min, in particular for an eye region, a crow’ s foot region and a glabella region.
  • gas in particular carbon dioxide (CO2)
  • CO2 carbon dioxide
  • the invention also relates to a kit comprising a device, in particular a cosmetic device, for the subcutaneous injection of gas as defined above, and a batch of replacement microneedles.
  • residual gases present in the microneedle means gases present in the microneedle and in the fluid connections before the injection is carried out, for example air, any gases present in the microneedle and coming, for example, from volatile components contained in the microneedle or from contamination of the microneedle by the external environment or by a user.
  • the device since the device is open, it is in contact with air that can enter and remain in the channel connected to the microneedle. Air can have a detrimental effect on the injection if there is contamination. In addition, the air can bias the actual quantity of gas to be injected.
  • 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.
  • the hollow microneedles comprise at least one internal channel.
  • 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.
  • the channel is longitudinal.
  • the microneedles can have a plurality of longitudinal and/or transverse channels.
  • the microneedles can have a circular hollow internal cross section.
  • the microneedles have a hollow internal section of other shapes, for example square, rectangular or triangular.
  • 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 forming the proximal end.
  • microneedles described in the documents EP 2 594 313 or US 8,236,368 can be used according to the invention.
  • the channels passing through the microneedles may be continuous or discontinuous. Preferably, they are continuous.
  • axis of elongation of a microneedle designates an axis passing through the barycentres of the transverse sections of the microneedle.
  • Each microneedle can comprise a stop configured to limit the depth of injection of the microneedle into the skin to less than or equal to 250 micrometres, preferably to 100 micrometres, more preferably to 50 micrometres.
  • a larger internal transverse dimension of each microneedle may be less than or equal to 100 micrometres, preferably less than or equal to 60 micrometres, more preferably less than or equal to 30 micrometres.
  • the largest internal transverse dimension of the microneedles can be chosen as a function of the desired volume of composition to be dispensed.
  • microneedles are preferably longer than the desired depth of injection.
  • the length of the microneedles can be chosen as a function of the targeted skin layer into which the composition is to be delivered, obtaining the appropriate depth in the skin.
  • Microneedles may be made of an inorganic material, preferably silicon, titanium, cobalt, ceramic, polyethylene or any material implantable in the skin and/or the body, and still more preferably stainless steel.
  • the microneedles have a force of attachment to their support (endpiece) greater than or equal to 5N, preferably greater than or equal to 3 ON, more preferably greater than or equal to 50N.
  • microneedles are preferably sterile or sterilized prior to use.
  • the microneedles are preferably disposable.
  • the microneedles are non-absorbable.
  • non-absorbable microneedles is to be understood as meaning that the microneedles do not dissolve or degrade in vivo, and that they have to be removed from the skin.
  • the depth of injection of the microneedle into the skin is preferably less than or equal to 250 micrometres, preferably less than or equal to 100 micrometres, more preferably less than or equal to 50 micrometres.
  • the device may cause the microneedles to perforate the skin to a deep level and then dispense the composition prior to removal of the device or indeed during removal of the device.
  • the device may be wirelessly connected to an electronic system, notably a personal computer or a smartphone, for controlling the injection.
  • an electronic system notably a personal computer or a smartphone
  • An injection of CO2 gas increases the blood flow in the skin, which can increase the oxygenation of the skin in order to decrease the intensity of dark circles.
  • the device comprises an electronic system.
  • OCT optical coherence tomography
  • confocal microscopy confocal microscopy
  • electron microscopy confocal microscopy
  • the OCT method can be used to monitor and locate the injection sites in the skin.
  • the OCT method can be useful for tracking the volume of gas filled inside the skin, scalp or lips.
  • the device according to the invention has one or more of the following features, taken alone or in combination:
  • the purge system is disposed upstream of the microneedle.
  • the purge system is disposed downstream of the distribution line.
  • the distribution line comprises a pressure regulator.
  • the distribution line comprises an upstream conduit for connecting the pressure regulator to a control switch and a downstream conduit for connecting the control switch to the microneedle.
  • the purge system is equipped with a main body including a valve.
  • the purge system comprises a two-stage switching mechanism.
  • the switching mechanism comprises an actuating button movable in the main body along a longitudinal axis (A), between a rest position in which the valve is closed and a first engagement position in which the valve is open and allows the gas to pass to the microneedle at a first flow rate, in order to evacuate, before injection, any residual gases stagnant in the microneedle.
  • the actuating button cooperates with the valve via a first elastic element of first stiffness (ki), to allow the gas to pass to the microneedle at the first flow rate, and the first elastic element is in a first compression state when the actuating button is in its first engagement position.
  • a first elastic element of first stiffness ki
  • the actuating button is movable in the main body along a longitudinal axis (A), between the first engagement position and a second engagement position in which the valve is open and allows the gas to pass to the microneedle at a second flow rate, in order to effect the injection.
  • the actuating button cooperates with the valve via the first elastic element of first stiffness (ki) and a second elastic element of stiffness (k2), in order to allow the gas to pass to the microneedle at the second flow rate, the first elastic element and the second elastic element together being in a second compression state when the actuating button is in its second engagement position.
  • the hollow microneedle comprises an internal channel of mean internal transverse dimension (IDmean) extending between a distal free end and a proximal end, the hollow microneedle for injection having a length (L) of less than or equal to 250 pm and greater than or equal to 70 pm and a ratio (IDmean/L) of the mean internal transverse dimension (IDmean) of the channel to its length (L) of between 0.15 and 0.86.
  • IDmean mean internal transverse dimension
  • the invention relates to a device, in particular a cosmetic device, for the subcutaneous injection of gas, in particular carbon dioxide (CO2), comprising a gas reservoir in fluidic communication with a hollow microneedle via a distribution line, the hollow microneedle comprising an internal channel of mean internal transverse dimension (IDmean) extending between a distal free end and a proximal end, the hollow microneedle for injection having a length (L) of less than or equal to 250 mm and of greater than or equal to 70 mm, and the microneedle for injection having a ratio (IDmean/L) of the mean internal transverse dimension (IDmean) of the channel to its length (L) of between 0.15 and 0.86.
  • CO2 carbon dioxide
  • 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 possible fillers.
  • the composition is delivered deeper into the skin, bypassing the SC layer.
  • the invention also relates to a method for subcutaneous injection of gas, in particular carbon dioxide (CO2), comprising (i) the use of a device as defined above, and (ii) the injection of the gas for a period of between 1 second and 15 seconds with a flow rate of between 20 ml/min and 60 ml/min, in particular for an eye region, a crow’ s foot region and a glabella region.
  • gas in particular carbon dioxide (CO2)
  • CO2 carbon dioxide
  • the microneedle is purged before the injection.
  • the invention also relates to a kit comprising a device, in particular a cosmetic device, for the subcutaneous injection of gas as defined above, and a batch of replacement microneedles.
  • the device according to the invention has one or more of the following features, taken alone or in combination:
  • the microneedle is configured to deliver the gas at a flow rate of less than 80 cm 3 /min, in particular at a flow rate of between 20 cm 3 /min and 60 cm 3 /min.
  • the distribution line comprises a pressure regulator.
  • the distribution line comprises a switch for controlling the distribution of gas to the microneedle.
  • the distribution line comprises an upstream conduit for connecting the pressure regulator to the control switch and a downstream conduit for connecting the control switch to the microneedle.
  • the distribution line comprises a purge system disposed upstream of the microneedle in order to evacuate, before an injection, residual gases stagnant in the microneedle.
  • the purge system is equipped with a main body including a valve.
  • the purge system comprises a two-stage switching mechanism. Description of the figures
  • Figure 1 shows a first embodiment of a device that can be used for carrying out the method according to the invention, comprising an ON/OFF button,
  • Figure 2 shows a first purge system that can be used in a device according to the invention, in a rest position
  • Figure 3 shows the purge system from Figure 2 in a first release position
  • Figure 4 shows the purge system from Figures 2 and 3 in a second release position
  • Figure 5 shows a second purge system that can be used in a device according to the invention
  • Figure 6 shows the operation of the second purge system from Figure 5: A in the rest position, B in the first release position, C in the second release position,
  • Figure 7 shows the purge system from Figures 5 and 6 integrated into a device according to the invention, in the rest position
  • Figure 8 shows the purge system from Figures 5 and 6 integrated into a device according to the invention, in the first release position
  • Figure 9 shows the purge system from Figures 5 and 6 integrated into a device according to the invention, in the second release position,
  • Figure 10 shows a visualization, by optical coherence tomography, of the CO2 gas injected by the method according to the invention with microneedles of length equal to 70 pm, for ex-vivo porcine skin.
  • microneedles of length equal to 70 pm, for ex-vivo porcine skin.
  • Figure 11 shows a visualization, by optical coherence tomography, of a treatment region before injection of CO2, into ex-vivo porcine skin,
  • Figure 12 shows a visualization, by optical coherence tomography, of the region from Figure 11 after injection of CO2 with a needle of total length equal to 70 pm, into ex-vivo porcine skin,
  • Figure 13 shows a comparison table of the ease/difficulty of injection according to the needle length (Ln) and the ratio (IDmean/Ln), for ex-vivo porcine skin,
  • Figure 14 shows a photo of ex-vivo porcine skin injected into at a rate of 80 cm 3 /min
  • Figure 15 shows a photo of ex-vivo porcine skin injected into at a rate of 30 cm 3 /min.
  • the method according to the invention involves the subcutaneous injection of gas, in particular carbon dioxide (CO2).
  • gas in particular carbon dioxide (CO2).
  • Figure 1 illustrates a device 100 according to the invention, intended to be brought into contact with the skin of a person in order to inject gas.
  • the skin is constituted, for example, of the facial skin, in particular the skin of the dark circles under the eyes.
  • the treatment involves treating region of the dark circles in order to rejuvenate the person’s expression.
  • the device 100 comprises a handpiece 101 which carries a gas reservoir 10, in contact with a distribution line 20, and from which gas, in particular CO2, is emitted towards a microneedle 4.
  • the pressure of the gas is advantageously between 40 and 70 bar.
  • the device 1 can be powered by a generator (not shown), which may or may not be part of the handpiece, for example being present within a base station to which the handpiece is connected by a cable.
  • a generator not shown
  • a pressure regulator 21 can be disposed, downstream of which a control button 23 can be placed for releasing the gas on command by the user.
  • the control button 23 can be actuated by the user between an “OFF” position, in which the gas is stopped and does not reach the microneedle, and an “ON” position, in which the gas can reach the microneedle for injection.
  • the control button is in the “OFF” position between two injections and in the “ON” position during the injection or just before the injection.
  • the pressure regulator 21 is optional if the pressure of the gas contained in the reservoir 10 is equal to the desired pressure of the gas for carrying out the injection.
  • the pressure regulator 21 can also be configured with a fixed pressure. It can be controlled by a control button 18.
  • the pressure regulator 21 is necessary for lowering the pressure of the gas entering the microneedle 4 so as to release the gas at regulated pressure.
  • the pressure of the gas is advantageously between 1.5 bar and 3 bar after it has passed through the pressure regulator 21.
  • the push-button 23 can be connected to the pressure regulator 21 by a first flexible conduit forming an upstream connection conduit 80, and to the microneedle 4 by a second flexible conduit forming a downstream connection conduit 81.
  • Figures 2 to 4 show a purge system that can be used in a device according to the invention. In the carboxytherapy device according to the invention, this purge system is inserted in place of the push-button 23 of Figure 1.
  • Figure 2 illustrates the purge system at rest.
  • the purge system 22 comprises a main body 50 comprising an internal gas passage 53 having a gas inlet 51, through which the gas at a first pressure flow rate value enters the internal passage 53 via the upstream conduit 80, and a gas outlet 52, through which the gas at a second pressure flow rate value is extracted from the internal passage 53 via the downstream conduit 81.
  • the purge system 22 is also equipped with a control push-button 31 which moves in translation along the longitudinal axis A under the action performed by a user on this control button.
  • Figure 3 shows the purge system 22 in a first release position allowing CO2 gas to pass from the upstream conduit 80 to the downstream conduit 81 at a low flow rate, in order to replace the air contained in the microneedle.
  • the push-button 31 has been moved by the user by the distance di along the axis A, in order to release the gas at low pressure into the downstream connection conduit 81 and then into the microneedle 4, for example at a flow rate of 10 cm 3 /min.
  • the push-button can be held in the first release position by a stop, optionally associated with a ring-shaped seal 37.
  • Figure 4 shows the purge system 22 in the second release position for injecting gas under the skin.
  • the push-button has been moved by the user by the distance d2 along the axis A, d2being greater than di, in order to release the gas at high pressure into the downstream connection conduit 81 and then into the microneedle 4, for example at a flow rate of 40 cm 3 /min.
  • the push-button can be held in the second release position by a stop, optionally associated with a ring-shaped seal 38.
  • the purge system 22 comprises a two-stage push system, including two springs 56, 66 capable of exerting a stress on the pressure-adjusting member 31.
  • Each spring 56, 66 has a spring length and a spring constant that is specific to it, the first spring 56 having a stiffness ki less than the stiffness k2 of the second spring 66.
  • the resistance of the assembly formed by the first and second springs is defined by the resistance of the weaker spring, that is to say by the resistance of the first spring 56, so that a valve (not shown) allows a limited quantity of CO2 gas to pass towards the microneedle.
  • the first spring 56 is in an intermediate position between its rest position in Figure 2 and its second position in Figure 4.
  • the resistance of the assembly is defined by the sum of the resistances of the two springs, and the valve allows gas to pass at full flow rate towards the microneedle 4 in order to carry out the injection.
  • the first spring 56 and the second spring 66 are in a state of maximum stress.
  • gas expansion means are arranged in the passage 53 between the inlet 51 and outlet 52 and serve to effect the desired gas pressure reduction.
  • the expansion means comprise, by way of example, an expansion valve cooperating with a valve seat, the expansion valve being able to be pushed back from its seat by an elastic means.
  • Figure 6 shows an example of a push-button that can be used to control the purge system 22 according to the invention.
  • the push-button is formed by a base 72 connected to a PCB, a push-button pad 74 being supported above the base to actuate the purge system.
  • the push-button structure has been designed for two purposes:
  • the rubber dome 70 plays the role of the first spring described with reference to Figures 2 to 4, i.e. to absorb shocks and to begin the downward action with low resistance.
  • the internal spring 71 located within the rubber dome 70, resists further with a higher resistance and allows gas to pass through when the force exerted by the user is sufficient and exceeds a predetermined threshold.
  • the internal spring 71 housed within the dome 70 provides a resistance to close the gas passage if there is no pressure on the dome 70, and it will make it possible to circulate a small volume of CO2 in order to purge the path when the user depresses the dome 70.
  • the internal spring 71 plays the role of the second helical spring described in connection with Figures 2 to 4, and this provides the resistance for purging and for allowing the gas to pass from the downstream conduit 81 to the upstream conduit 82.
  • Figures 7 to 9 illustrate the operation of the purge system described with reference to Figures 5 and 6 in a device according to the invention.
  • the device shown in Figures 7 to 9 is identical to that shown in Figures 2 to 4, except that the purge system has been replaced by the one described in isolation in Figures 5 and 6.
  • the purge system shown in Figure 7 uses elastic elements that each have their own elasticity, the constituent materials of these elastic elements being different and therefore being associated with an elasticity specific to them.
  • the elastic material of the outer dome 70 can be silicone, elastomer, rubber or sponge.
  • the dome 70 provides a small resistance in order to hold the switch in the closed position. It can be actuated by the small pressure applied by the action of a user in order to carry out a purge and to emit into the channel 81 gas, in particular CO2.
  • the gas mixes with the gaseous residues 101 initially present in the microneedle and progressively dilutes these gaseous residues so as to occupy entirely the internal channel of the microneedle 4.
  • the valve will be allowed to open at a certain level of gas pressure, and the user will feel a slight resistance pressure with a resistance coming from the internal spring 71.
  • the spring 71 absorbs the higher pressure by the change of shape, and the valve will be fully opened for maximum gas delivery.
  • the invention is not limited to purge systems equipped with the twin-action mechanisms described above. On the contrary, the invention relates to all devices for subcutaneous injection of gas that are equipped with a microneedle purge system, regardless of the structure of this system, in order to remove the gas initially present in the microneedle and decontaminate the latter, without limiting its application by the specific structure of the embodiment.
  • Tests to evaluate the device according to the invention were carried out on ex-vivo porcine skins.
  • Figure 10 illustrates the penetration and distribution of CO2 under the skin, after injection with a device according to the invention, under the following conditions:
  • porcine skin was prepared as follows: Untreated, stored in a refrigerator at 5°C overnight and used the next day as follows: Excised with a scalpel at room temperature, the hairs were cut gently with surgical scissors so as to keep the skin intact.
  • the OCT equipment used is a Ganymede II Thorlabs.
  • Bubbles of CO2 that have penetrated under the skin are observed, located at a depth of between 100 and 300 pm. More bubbles are observed when the injected volume is larger. These bubbles disappear within about 10 minutes.
  • Figure 12 shows a histological section of the skin before CO2 injection
  • Figure 11 shows a histological section of the skin immediately after CO2 injection, typically under the injection conditions of Figure 10, with an injection time of 1 second. Bubbles are observed in the dermis. The injection of CO2 does not cause any apparent skin damage.
  • the microneedle Up to a length of 150 pm, the microneedle is injected easily, without resistance, into the stratum corneum or epidermis (so as not to reach the dermis). This specification is essential for achieving a gas distribution at a shallow depth of the skin.
  • a length of 70 pm has proven appropriate for injecting CO2 into ex-vivo porcine skin.
  • the CO2 gas is successfully injected with microneedles of 70 pm, 150 pm and 250 pm (total length) into ex-vivo porcine skin.
  • Figure 14 shows a photograph of ex-vivo porcine skin immediately after treatment by the device according to the invention, under the following conditions:
  • Figure 15 shows a photograph of ex-vivo porcine skin immediately after treatment by the device according to the invention, under the following conditions:

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Medical Informatics (AREA)
  • Devices For Medical Bathing And Washing (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif (100), en particulier un dispositif cosmétique, pour l'injection sous-cutanée de gaz, en particulier de dioxyde de carbone (CO2), comprenant un réservoir de gaz (10) en communication fluidique avec une micro-aiguille creuse (4) par l'intermédiaire d'une ligne de distribution (20). Le dispositif comprend également un système de purge (22) pour évacuer les gaz résiduels présents dans la micro-aiguille.
PCT/EP2024/057729 2023-04-07 2024-03-22 Dispositif de carboxythérapie à micro-aiguille creuse Pending WO2024208607A1 (fr)

Priority Applications (2)

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KR1020257036975A KR20250162937A (ko) 2023-04-07 2024-03-22 중공 마이크로니들을 포함하는 카복시테라피 장치
CN202480024195.5A CN121038843A (zh) 2023-04-07 2024-03-22 具有中空微针的二氧化碳治疗设备

Applications Claiming Priority (2)

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FR2303495A FR3147506B1 (fr) 2023-04-07 2023-04-07 Dispositif de carboxytherapie avec micro-aiguille creuse
FRFR2303495 2023-04-07

Publications (1)

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WO2024208607A1 true WO2024208607A1 (fr) 2024-10-10

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PCT/EP2024/057729 Pending WO2024208607A1 (fr) 2023-04-07 2024-03-22 Dispositif de carboxythérapie à micro-aiguille creuse

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KR (1) KR20250162937A (fr)
CN (1) CN121038843A (fr)
FR (1) FR3147506B1 (fr)
WO (1) WO2024208607A1 (fr)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040019331A1 (en) * 2000-03-09 2004-01-29 Yehoshua Yeshurun Systems and methods for the transport of fluids through a biological barrier and production techniques for such systems
AU2005200910A1 (en) * 1999-06-04 2005-03-24 Georgia Tech Research Corporation Devices and methods for enhanced microneedle penetration of biological barriers
US8236368B2 (en) 2006-07-21 2012-08-07 Industry-Academic Cooperation Foundation, Yonsei University Method for preparing a hollow microneedle
EP2594313A2 (fr) 2010-07-12 2013-05-22 Incyto Co., Ltd. Micro-aiguille creuse ayant une apparence variable
WO2014142970A1 (fr) 2013-03-15 2014-09-18 Plum Systems Co. Appareil et procédé pour le rajeunissement tissulaire
WO2020064085A1 (fr) * 2018-09-24 2020-04-02 L'oreal Dispositif comprenant des micro-aiguilles pour l'administration de charges cosmétiques
WO2022231011A1 (fr) * 2021-04-28 2022-11-03 L'oreal Dispositif pour une thérapie par injection de fluide
FR3125428A1 (fr) * 2021-07-20 2023-01-27 L'oreal Dispositif pour thérapie cosmétique

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AU2005200910A1 (en) * 1999-06-04 2005-03-24 Georgia Tech Research Corporation Devices and methods for enhanced microneedle penetration of biological barriers
US20040019331A1 (en) * 2000-03-09 2004-01-29 Yehoshua Yeshurun Systems and methods for the transport of fluids through a biological barrier and production techniques for such systems
US8236368B2 (en) 2006-07-21 2012-08-07 Industry-Academic Cooperation Foundation, Yonsei University Method for preparing a hollow microneedle
EP2594313A2 (fr) 2010-07-12 2013-05-22 Incyto Co., Ltd. Micro-aiguille creuse ayant une apparence variable
WO2014142970A1 (fr) 2013-03-15 2014-09-18 Plum Systems Co. Appareil et procédé pour le rajeunissement tissulaire
WO2020064085A1 (fr) * 2018-09-24 2020-04-02 L'oreal Dispositif comprenant des micro-aiguilles pour l'administration de charges cosmétiques
WO2022231011A1 (fr) * 2021-04-28 2022-11-03 L'oreal Dispositif pour une thérapie par injection de fluide
FR3125428A1 (fr) * 2021-07-20 2023-01-27 L'oreal Dispositif pour thérapie cosmétique

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"Microneedles for transdermal drug delivery", ADVANCED DRUG DELIVERY REVIEWS, vol. 56, 27 March 2004 (2004-03-27), pages 581 - 587
DEVIN V. MCALLISTER ET AL.: "Microfabricated needles for transdermal administration of macromolecules and nanoparticles: manufacturing methods and transport studies, transport studies", PNAS, vol. 100, no. 24, 25 November 2003 (2003-11-25), pages 13755 - 13760
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Also Published As

Publication number Publication date
FR3147506B1 (fr) 2025-03-28
CN121038843A (zh) 2025-11-28
KR20250162937A (ko) 2025-11-19
FR3147506A1 (fr) 2024-10-11

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