WO2022244855A1 - Device for cosmetic therapy - Google Patents

Device for cosmetic therapy Download PDF

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Publication number
WO2022244855A1
WO2022244855A1 PCT/JP2022/020898 JP2022020898W WO2022244855A1 WO 2022244855 A1 WO2022244855 A1 WO 2022244855A1 JP 2022020898 W JP2022020898 W JP 2022020898W WO 2022244855 A1 WO2022244855 A1 WO 2022244855A1
Authority
WO
WIPO (PCT)
Prior art keywords
needles
handle portion
fluid
gas
hollow
Prior art date
Application number
PCT/JP2022/020898
Other languages
French (fr)
Inventor
Charlotte Pellet
Woo Ram Park
Vishal Sharma
Original Assignee
L'oreal
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
Priority claimed from JP2021085379A external-priority patent/JP2022178516A/en
Priority claimed from FR2107808A external-priority patent/FR3125428B1/en
Application filed by L'oreal filed Critical L'oreal
Publication of WO2022244855A1 publication Critical patent/WO2022244855A1/en

Links

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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
    • A61M5/3298—Needles arranged in parallel
    • 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
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/04—Skin

Definitions

  • the present invention relates to a device for cosmetic therapy.
  • Carboxytherapy is a medical treatment, widely used with success in different fields of medicine.
  • WO 2014/142970 discloses a carboxytherapy device for injecting CO2 gas into a skin.
  • Carboxytherapy consists in injection of CO2 into dermis and shows very strong performance in facial anti-aging, especially for reduction of dark circles. Indeed, dark circles result from a variety of factors including deep facial anatomy (such as dermal capillary network), contributions from the skin (such as excessive pigmentation), aging degradation of soft tissue (such as thin skin, or shadowing due to skin laxity), etc. The variety of factors make the problem of dark circles very complicated.
  • CO2 injection brings multiple benefits such as oxygenation, improvement of microcirculation, anti-inflammation, and collagen stimulation, which can cater to the above multifactorial problem.
  • the clinically observed cosmetic benefit is an improvement of under-eye circle pigmentation, i.e. brightening around the eyes.
  • HA hyaluronic acid
  • carboxytherapy and mesotherapy are dispensed sequentially, one after another.
  • CO2 gas is delivered through a classical 30G or 32G needle, and then active ingredients are injected through other needle(s), or vice versa.
  • Another common practice is to apply topically a cream, lotion or serum, containing active ingredients such as HA, as a post-treatment after carboxytherapy.
  • An object of the present invention is to provide a device which can improve the efficiency in the combination of fluid injection therapy such as carboxytherapy and mesotherapy.
  • the device comprises an injecting unit and a fluid supply unit.
  • the injecting unit comprises a handle portion comprising a fluid passage, one or more hollow first needles at an end of the handle portion, the one or more hollow first needles having an inner passage in fluid communication with the fluid passage, and one or more second needles including water-soluble or water-dispersible material, the one or more second needles being separable from the handle portion.
  • the fluid supply unit is configured to supply a fluid to the fluid passage.
  • the injecting unit may have an application surface, on which the one or more hollow first needles and the one or more second needles protrude toward the same side so as to be applied to a user’s skin together.
  • the injecting unit may comprise a patch portion removably attached to the handle portion, the patch portion supporting the one or more second needles.
  • the patch portion may comprise an adhesive layer configured to support the one or more second needles and adhere to a user’s skin.
  • the patch portion may be configured to be detached from the handle portion while leaving the one or more hollow first needles on the handle portion.
  • the patch portion may comprise one or more holes for allowing the one or more hollow first needles to pass therethrough.
  • the handle portion may comprise a separation mechanism configured to operably separate the patch portion from the handle portion.
  • the handle portion may have an inner space and the separation mechanism may be accommodated in the inner space.
  • the water-soluble or water-dispersible material may be at least one selected from the group consisting of hyaluronic acid, monosaccharides, disaccharides, oligosaccharides, polysaccharides, dextrins, dextrans, polyethylene glycols, polyvinyl alcohols, poly(methylvinylether/maleic anhydride), polyvinylpyrrolidone, poly(methyl/vinyl ether/maleic acid), hydrolyzed collagen, and esters thereof, and poly(methyl/vinyl ether/maleic anhydride).
  • the one or more hollow first needles may be removably attached to the handle portion.
  • the lengths of the one or more hollow first needles and the one or more second needles may be between 20 pm and 1,000 pm.
  • the fluid supply unit may comprise a fluid storage and a pressure regulator operably allowing the fluid to be supplied to the fluid passage.
  • the fluid may be carbon dioxide gas.
  • FIG. 1 is a plan view of the device 1 for cosmetic therapy according to the embodiment.
  • FIG. 2 is a front view of the device 1 for cosmetic therapy according to the embodiment.
  • FIG. 3 is a cross-sectional view of the device 1 for cosmetic therapy according to the embodiment along the line III-III in FIG. 2.
  • FIG. 4 is a front view of the device 1 for cosmetic therapy according to the embodiment, without the patch portion 14.
  • FIGS. 5 A and 5B are cross-sectional views of the device 1 for cosmetic therapy according to the embodiment along the line V-V in FIG. 4.
  • FIGS. 6A to 6D are schematic views of how to use the device 1 for cosmetic therapy. BEST MODE FOR CARRYING OUT THE INVENTION
  • a fluid to be injected is not limited to CO2, but may be any fluid including a gas such as N2O, NO, O2, or H2, mixture gas, liquid, mixture liquid, medical solution, or other fluid, or a combination thereof.
  • FIG. 1 is a plan view of the device 1 for cosmetic therapy according to the embodiment.
  • the device 1 includes an injecting unit 10 and a gas supply unit 50.
  • the injecting unit 10 and the gas supply unit 50 may be formed integrally or non-separably, or may be removably attached to each other.
  • the gas supply unit 50 is detachable from the injecting unit 10 below, it is not necessarily required.
  • FIG. 2 is a front view of the device 1 for cosmetic therapy according to the embodiment.
  • FIG. 3 is a cross-sectional view of the device 1 for cosmetic therapy according to the embodiment along the line III-III in FIG. 2.
  • FIG. 4 is a front view of the device 1 for cosmetic therapy according to the embodiment, without the patch portion 14.
  • FIGS. 5A and 5B are cross-sectional views of the device 1 for cosmetic therapy according to the embodiment along the line V-V in FIG. 4.
  • the injecting unit 10 delivers CO2 gas therethrough into a skin S of a user and supplies active ingredients into the skin S.
  • the injecting unit 10 includes a handle portion 12 and a patch portion 14.
  • the handle portion 12 serves as a handgrip for the user in use.
  • the handle portion 12 includes a main body 20, a gas nozzle 22, a hollow first needle 24, a pushing member 26 (an example of “separation mechanism”), a slide lever 28, and a connector 30,
  • the main body 20 is a body portion of the handle portion 12.
  • the shape of the main body 20 can be determined depending on the application.
  • the main body 20 has a curved shape which is ergonomically easy to grip, as shown in FIG. 1.
  • the direction in which the proximal end of the main body 20 is directed intersects with the direction in which the distal end of the main body 20 is directed.
  • the main body 20 has an attachment surface 32 at the distal end thereof.
  • the patch portion 14 is attached to the attachment surface 32 in use as shown in FIG. 1.
  • the attachment surface 32 has a crescent-moon shape as shown in FIG. 4.
  • the attachment surface 32 has openings which accommodate the gas nozzle 22 and pushers 38 of the pushing member 26, which will be described below.
  • the main body 20 has inner space which accommodates a gas passage 34 (an example of “fluid passage”) and the pushing member 26, as shown in FIGS. 3, 5A, and 5B.
  • the gas passage 34 is connected to the gas supply unit 50 and passes through the main body 20 from the proximal end thereof to the distal end thereof (i.e. the attachment surface 32) to supply CO2 gas from the gas supply unit 50 to the skin S.
  • the gas passage 34 is a flexible tube member in the inner space of the main body 20.
  • the gas passage 34 may at least partially be formed outside of the main body 20. Note that the gas passage 34 may be the inner space of the main body 20 itself, without a tube member.
  • the gas nozzle 22 is an injection nozzle of CO2 gas from the gas passage 34.
  • the gas nozzle 22 is provided on the attachment surface 32 and connected to the gas passage 34.
  • the gas nozzle 22 has a cylindrical shape protruding on the gas nozzle 22.
  • the first needle 24 is a hollow needle for injecting CO2 gas from the gas nozzle 22 into the skin S.
  • the first needle 24 is attached to the gas nozzle 22 as shown in FIG. 3.
  • the first needle 24 is removably attached to the gas nozzle 22 so as to surround the outer surface of the gas nozzle 22.
  • the first needle 24 has an inner passage in fluid communication with the gas passage 34 via the gas nozzle 22.
  • the first needle 24 has a tapered cylindrical shape which is adapted to penetrate the skin S.
  • the injecting unit 10 can have one or more first needles 24.
  • one first needle 24 at the center of the attachment surface 32 is shown in FIGS. 1 and 2.
  • the number of the first needle 24 is not limited to this embodiment.
  • the first needle 24 may also be positioned at the end of the attachment surface 32. It should be noted that the injecting unit 10 does not have to have multiple first needles 24 since a single first needle 24 is enough to provide the sufficient amount of CO2 gas into the skin S in use because of fast and effective diffusion of CO2 gas.
  • the material of the first needle 24 is, for example, metal such as stainless steel, silicone compound, biodegradable polymer, thermoplastic resin, water-soluble polymer, etc.
  • Biodegradable polymer is, for example, polyglycolic acid (PGA) or polylactic acid (PLA).
  • Thermoplastic resin is, for example, medical silicone, polymer materials, ultraviolet curing resins, polydimethylsiloxane, polycarbonate, or cyclic olefin copolymer.
  • Water-soluble polymer is, for example, carboxymethyl cellulose (CMC), methyl cellulose (MC), hydroxypropyl cellulose (HPC), hydroxypropyl methyl cellulose (HPMC), polyvinyl alcohol (PVA), polyacrylic acid-based polymer, polyacrylamide (PAM), polyethylene oxide (PEO), purulan, alginate, pectin, chitosan, chitosan succinamide, or oligochitosan.
  • CMC carboxymethyl cellulose
  • MC methyl cellulose
  • HPC hydroxypropyl methyl cellulose
  • PVA polyvinyl alcohol
  • PAM polyacrylamide
  • PEO polyethylene oxide
  • purulan purulan, alginate, pectin, chitosan, chitosan succinamide, or oligochitosan.
  • the length of the first needle 24 can be determined depending on the target depth.
  • the first needle 24 has a length between 20 pm and 1,000 pm, and for cosmetic application, the first needle 24 may have a length between 50 pm and 300 pm to deliver the gas into a shallow layer of the skin S such as stratum comeum or epidermis.
  • the injecting unit 10 with the first needle 24 having a length between 50 pm and 300 pm can reduce the user’s pain since the first needle 24 is inserted into a shallow layer such as stratum comeum or epidermis, but not into deep layers such as dermis.
  • the length of the first needle 24 is too large, it would cause pain.
  • the length of the first needle 24 is too small, it would be difficult to insert the first needle 24 into the skin S.
  • the length of the first needle 24 is not limited to this embodiment.
  • the outer diameter of the first needle 24 can be determined depending on the application.
  • the outer diameter (e.g. the maximum outer diameter) of the first needle 24 is between 40 pm and 200 pm, and preferably between 50 pm to 120 pm for cosmetic application of gas delivery without pain or severe discomfort.
  • the outer diameter of the first needle 24 may be no less than 60 pm, 70 pm, 80 pm, 90 pm, or 100 pm, and no more than 190 pm, 180 pm, 170 pm, 160 pm, or 150 pm. If the outer diameter of the first needle 24 is too small, the first needle 24 would be easily broken during the insertion into the skin S. On the other hand, if the outer diameter of the first needle 24 is too large, it would cause pain.
  • the first needle 24 is a microneedle.
  • the pushing member 26 is a separation mechanism to push off the patch portion 14 from the attachment surface 32.
  • the slide lever 28 is an operational switch which is used in combination with the pushing member 26.
  • the pushing member 26 is movably provided in the inner space of the main body 20.
  • the slide lever 28 is connected to one end of the pushing member 26 and exposed on the outer surface of the main body 20.
  • the slide lever 28 can slide on the outer surface of the main body 20 between a normal position in FIG. 5A and a pushing position in FIG. 5B.
  • the pushing member 26 moves along the Z direction together with the movement of the slide lever 28.
  • the pushing member 26 includes a transfer member 36 and three pushers 38.
  • the transfer member 36 transfers the user’s force on the slide lever 28 to the pushers 38.
  • One end of the transfer member 36 is connected to the slide lever 28 while the other end is trifurcate and connected to each of the pushers 38.
  • the transfer member 36 moves from the normal position to the pushing position as well.
  • the inner space of the main body 20 is larger than the size of the transfer member 36 such that the transfer member 36 can move between the normal position and the pushing position.
  • the pushers 38 contact the patch portion 14 on the attachment surface 32 and push off the patch portion 14 from the attachment surface 32.
  • the number, shape of the pushers 38 can be determined depending on the application. In this embodiment, three pushers 38 with an oval plate shape are provided at the trifurcate end of the transfer member 36 as shown in FIG. 4 so as to provide the pushing member 26 with a plurality of pushing points.
  • the pushers 38 In the normal position in FIG. 5A, the pushers 38 are housed in the openings on the attachment surface 32. In the pushing position in FIG. 5B, the pushers 38 get out of the openings of the attachment surface 32 to push the patch portion 14.
  • the present invention is not limited to this embodiment. Any other mechanism is available to separate the patch portion 14 from the handle portion 12.
  • the connector 30 connects the main body 20 to the gas supply unit 50 to allow the gas supply unit 50 to supply CO2 gas into the gas passage 34.
  • the connector 20 is a cylindrical portion provided on the proximal end of the main body 20 in communication with the gas passage 34. Any known connecting mechanism is possible for the connector 30. Note that if the gas supply unit 50 is non-separably formed with the injecting unit 10, the connector 30 may be omitted.
  • the patch portion 14 is applied to the skin S of the user and injects active ingredients into the skin S.
  • the patch portion 14 is attached to the attachment surface 32 at the distal end of the handle portion 12.
  • the patch portion 14 has a crescent-moon shape similar to that of the attachment surface 32 as shown in FIG. 2.
  • the patch portion 14 has substantially the same shape as that of the attachment surface 32 in the XY plane.
  • the crescent-moon shape is suitable for application to skin under an eye.
  • the patch portion 14 includes an adhesive layer 40, a separation layer 42, and second needles 44.
  • the adhesive layer 40 is directly applied to and adheres to the skin S of the user.
  • One surface of the adhesive layer 40 which faces the skin S of the user serves as an application surface of the injecting unit 10.
  • the adhesive layer 40 is at least partially made of any kind of adhesive.
  • the adhesive layer 40 is of typical medical adhesive, which can be made from a variety of materials, such as natural rubber or synthetic rubber including hydrocolloids, polyacrylates, hydrogels, polyurethanes, or silicone.
  • the separation layer 42 facilitates separation of the patch portion 14 from the attachment surface 32.
  • the separation layer 42 is provide between the adhesive layer 40 and the attachment surface 32 and bonded to the adhesive layer 40.
  • the separation layer 42 can be bonded to, e.g. adhere to, the attachment surface 32 less strongly than to the adhesive layer 40.
  • the separation layer 42 is made of silicone material or hydro gel.
  • a needle hole 46 for accommodating the first needle 24 is formed in the adhesive layer 40 and the separation layer 42.
  • the needle hole 46 allows the first needle 24 on the attachment surface 32 to pass therethrough and protrude from the adhesive layer 40 toward the skin S.
  • the needle hole 46 is formed at the center of the adhesive layer 40 and the separation layer 42 in FIG. 3, it depends on the position of the first needle 24.
  • the second needles 44 are inserted into the skin S and can at least partially be dissolved or dispersed into the skin S.
  • the second needles 44 are provided on and protrude from the adhesive layer 40 at the distal end of the handle portion 12.
  • the second needles 44 are positioned adjacent to the first needle 24 on the adhesive layer 40.
  • the second needles 44 are supported by the patch portion 14, specifically by the adhesive layer 40.
  • the number, density, and arrangement of the second needles 44 can be determined depending on the application.
  • the patch portion 14 can have one or more second needles 44.
  • four second needles 44 around one first needle 24 are shown in FIGS. 1 and 2.
  • the number of the second needles 44 is not limited to this embodiment.
  • the first needle 24 may also be positioned at the side of the adhesive layer 40, not at the center surrounded by the second needles 44.
  • the second needles 44 are at least partially, preferably entirely, made of water-soluble or water-dispersible material, e.g. water-soluble or water-dispersible polymer.
  • the water-soluble or water-dispersible material is at least one selected from the group consisting in hyaluronic acid, monosaccharides, disaccharides, oligosaccharides, polysaccharides, dextrins, dextrans, polyethylene glycols, polyvinyl alcohols, poly(methylvinylether/maleic anhydride), polyvinylpyrrolidone, poly(methyl/vinyl ether/maleic acid) (PMVE/MA), hydrolyzed collagen, and esters thereof, and poly(methyl/vinyl ether/maleic anhydride) (PM VE/M AH).
  • the water-soluble or water-dispersible material of the second needles 44 is dissolved in water or bodily fluid.
  • Each second needle 44 has, for example, a pointed and tapered shape so as to penetrate the skin S.
  • the second needles 44 may have a solid body or a hollow body.
  • the length and outer diameter of the second needles 44 can be determined depending on the application.
  • the second needles 44 have substantially the same or similar size as the first needle 24.
  • the second needles 44 may have a length between 20 pm and 1,000 pm, and for cosmetic application, the second needles 44 may have a length between 50 pm and 250 pm to deliver the gas into a shallow layer of the skin S such as stratum comeum or epidermis.
  • the second needles 44 may have an outer diameter (e.g. the maximum outer diameter) between 40 pm and 200 pm.
  • the second needles 44 are microneedles.
  • the length and outer diameter of the second needles 44 are not limited to this embodiment.
  • the gas supply unit 50 stores CO2 gas inside and supplies CO2 gas into the injecting unit 10.
  • the gas supply unit 50 includes a gas storage 52 and a pressure regulator 54.
  • the gas storage 52 is a cartridge for storing CO2 gas in high pressure (e.g. more than several MPa or tens MPa) with variation by the usage of the gas.
  • a conventional and exchangeable gas cylinder can be used as the gas storage 52.
  • the volume of the gas storage 52 is 10 mLto 20 mL.
  • the gas storage 52 is removably connected to the pressure regulator 54.
  • the pressure regulator 54 delivers CO2 gas from the gas storage 52 to the gas passage 34 and regulates the pressure of the delivered CO2 gas.
  • the pressure regulator 54 controls the pressure of CO2 gas, which is to be delivered to the gas passage 34, to be constant and reduces the pressure of CO2 gas from the gas storage 52 down to a supply pressure for the gas passage 34.
  • the supply pressure can be determined depending on the application. For example, the supply pressure is between 0.15 MPa (1.5 bar) and 0.4 MPa (4 bar). Thereby, the pressure regulator 54 can maintain the pressure of CO2 gas consistently and steadily supply the moderate pressure of CO2 gas to the gas passage 34.
  • the pressure regulator 54 includes an injection switch 56 and a gas storage connector 58.
  • the injection switch 56 is a unit for the user to start/stop the injection of CO2 gas into the gas passage 34.
  • the injection switch 56 may be embodied as a manual button as shown in FIG. 1.
  • the injection switch 56 can be configured as a button to start the injection of CO2 gas into the gas passage 34 when the user presses the injection switch 56 and to stop the injection when the user releases the injection switch 56.
  • a one-way valve (not shown) is provided at one end of the pressure regulator 54 to be connected to the injecting unit 10.
  • the one-way valve allows CO2 gas to pass therethrough only in one direction from the pressure regulator 54 to the gas passage 34. Thereby, the one way valve can prevent counter flow of CO2 gas from the gas passage 34 to the pressure regulator 54.
  • the gas storage connector 58 connects the gas storage 52 to the pressure regulator 54. Any known connecting mechanism is possible for the gas storage connector 58.
  • the user first attaches the first needle 24 to the gas nozzle 22 of the handle portion 12. Next, the user attaches the patch portion 14 to the attachment surface 32 such that the first needle 24 passes through the needle hole 46. The user also attaches the injecting unit 10 to the gas supply unit 50 to assemble the device 1. Then, the user grips the main body 20 and applies the patch portion 14 to the skin S to insert the first needle 24 and the second needles 44 on the adhesive layer 40 into the skin S.
  • the user can operate the injection switch 56 to supply CO2 gas from the gas storage 52 through the gas passage 34 into the skin S to perform carboxytherapy.
  • active ingredients of the second needles 44 are progressively dissolved or dispersed into the skin S, e.g. stratum comeum and/or epidermis, so that mesotherapy is performed along with carboxytherapy.
  • CO2 gas may diffuse into deeper layers of the skin S than the active ingredients.
  • the user After the completion of injecting the predetermined amount of CO2 gas into the skin S, the user operates the slide lever 28 to actuate the pushing member 26.
  • the slide lever 28 slides from the normal position (FIG. 6A) to the pushing position (FIG. 6B).
  • the transfer member 36 moves in the +Z direction to transfer the user’s force on the slide lever 28 to the pushers 38, and the pushers 38 push the patch portion 14 toward the skin S.
  • the separation layer 42 is separated from the attachment surface 32 and the patch portion 14 is left on the skin S with the second needles 44 staying in the skin S.
  • the first needle 24 leaves the skin S together with the handle portion 12 as shown in FIG. 6B.
  • the slide lever 28 After pushing off the patch portion 14 from the handle portion 12, the slide lever 28 goes back to the normal position along with the pushing member 26 as shown in FIG. 6C.
  • the patch portion 14 the adhesive layer 40 continues to adhere to the skin S with the second needles 44 left in the skin S and the dissolution of the second needles 44 continues.
  • the user detaches the first needle 24 from the handle portion 12 as shown in FIG. 6D.
  • the user can detach the first needle 24 manually or by means of any detachment mechanism, e.g. like the slide lever 28.
  • the user can detach the patch portion 14 and the first needle 24 in two-step actions, i.e. the user can remove the patch portion 14 from the handle portion 12 in the first action and then remove the first needle 24 from the handle portion 12 in the second action.
  • the user may also detach the gas supply unit 50 from the handle portion 12 or detach the gas storage 52 from the gas supply unit 50. After the completion of mesotherapy, the user removes the patch portion 14 from the skin S.
  • the patch portion 14 and the first needle 24 may be entirely a single-use unit and disposable. Since the handle portion 12 except for the first needle 24 can be used repeatedly by disposing the patch portion 14 and the first needle 24, it is cost-effective. It is also possible to use the patch portion 14 and the first needle 24 multiple times as long as they are subject to effective sterilization.
  • the user can perform both carboxytherapy and mesotherapy.
  • the device 1 can be used to treat dark circles on the skin S and may also be used for other application such as wrinkle and fine line reduction, scar management, stretch mark reduction, etc.
  • hyaluronic acid is effective for dark circle reduction.
  • any other water-soluble or water-dispersible active ingredients may be used.
  • the device 1 it is possible to inject CO2 gas along with active ingredients such as hyaluronic acid in a single gesture.
  • the user can easily perform simultaneous inj ection of CO2 gas and active ingredients by the device 1. This may lead to two different benefit for hydration and dark circle reduction by a single treatment. Moreover, this can save time and reduce burdens to the user, and can also lead to more synergistic effects between carboxytherapy and mesotherapy during the simultaneous injection. This increases treatment efficacy and long-lastingness.
  • the CO2 flow into skin tissues may help the active ingredients to penetrate and spread into tissues for a better filler/hydration action. This effect is different from the conventional sequential procedure of gas injection and active ingredient injection.
  • the patch portion 14 and the first needle 24 are removable from the handle portion 12. Thereby, the handle portion 12 can easily be reused.
  • the patch portion 14 can be separated from the handle portion 12 and adhere to the skin S of the user. Thereby, the user does not have to hold the device 1 during the treatment.
  • the patch portion 14 can be detached from the handle portion 12 while leaving the first needle 24 on the handle portion 12. Thereby, non-water- soluble first needle 24 can be removed while water-soluble or water-dispersible second needles 44 stay on the skin S to allow the active ingredients to continue to spread.
  • the patch portion 14 comprises a needle hole 46 for allowing the first needle 24 to pass therethrough.
  • the first needle 24 protrudes from the adhesive layer 40 together with the second needles 44, and thus the patch portion 14 can support both the first needle 24 and the second needles 44 to be stably applied to the skin S.
  • the handle portion 12 has an inner space and the pushing member 26 is accommodated in the inner space.
  • the outer structure of the device 1 can be simplified so as to facilitate the handling of the device 1.
  • Tests were performed using a device comprising a CO2 cartridge, a pressure regulator, an injection button, and a single hollow microneedle tip. CO2 bubbles were observed into the skin using Optical Coherence Tomography after injection. Accordingly, it has been proved to be feasible to inject CO 2 gas into the skin with hollow microneedles.

Abstract

The present invention relates to a device for cosmetic therapy. The device comprises an injecting unit and a fluid supply unit. The injecting unit comprises a handle portion comprising a fluid passage, one or more hollow first needles at an end of the handle portion, the one or more hollow first needles having an inner passage in fluid communication with the fluid passage, and one or more second needles including water-soluble or water-dispersible material, the one or more second needles being separable from the handle portion. The fluid supply unit is coupled to the handle portion and configured to supply a fluid to the fluid passage.

Description

DESCRIPTION
TITLE OF INVNEITON DEVICE FOR COSMETIC THERAPY
TECHNICAL FIELD
[0001]
The present invention relates to a device for cosmetic therapy.
BACKGROUND ART
[0002]
Dark circles on a skin is a consumer’s big concern and is still an unaddressed issue. Cosmetics are the only at-home solutions but are not completely satisfactory to many. On the other hand, more invasive procedures do exist, but have to be performed in clinics.
[0003]
. Carboxytherapy is a medical treatment, widely used with success in different fields of medicine. For example, WO 2014/142970 discloses a carboxytherapy device for injecting CO2 gas into a skin. Carboxytherapy consists in injection of CO2 into dermis and shows very strong performance in facial anti-aging, especially for reduction of dark circles. Indeed, dark circles result from a variety of factors including deep facial anatomy (such as dermal capillary network), contributions from the skin (such as excessive pigmentation), aging degradation of soft tissue (such as thin skin, or shadowing due to skin laxity), etc. The variety of factors make the problem of dark circles very complicated. CO2 injection brings multiple benefits such as oxygenation, improvement of microcirculation, anti-inflammation, and collagen stimulation, which can cater to the above multifactorial problem. The clinically observed cosmetic benefit is an improvement of under-eye circle pigmentation, i.e. brightening around the eyes.
[0004]
Mesotherapy, consisting of the injection of active ingredients into the skin, is often combined with carboxytherapy to bring complementary effects and increase treatment performance. One of the key active ingredients of mesotherapy is hyaluronic acid (HA), which is well-known for its efficacy in eye contour treatment (increasing hydration, preventing dryness around delicate eye area, improving fine lines with filler role).
[0005]
In the existing treatments, carboxytherapy and mesotherapy are dispensed sequentially, one after another. Firstly CO2 gas is delivered through a classical 30G or 32G needle, and then active ingredients are injected through other needle(s), or vice versa. Another common practice is to apply topically a cream, lotion or serum, containing active ingredients such as HA, as a post-treatment after carboxytherapy.
[0006]
However, such a sequential procedure takes much time and is a burden to users. DISCLOSURE OF INVENTION
[0007]
An object of the present invention is to provide a device which can improve the efficiency in the combination of fluid injection therapy such as carboxytherapy and mesotherapy.
[0008]
In order to achieve the above-described object, one aspect of the present invention provides a device for cosmetic therapy. The device comprises an injecting unit and a fluid supply unit. The injecting unit comprises a handle portion comprising a fluid passage, one or more hollow first needles at an end of the handle portion, the one or more hollow first needles having an inner passage in fluid communication with the fluid passage, and one or more second needles including water-soluble or water-dispersible material, the one or more second needles being separable from the handle portion. The fluid supply unit is configured to supply a fluid to the fluid passage.
[0009]
According to one aspect of the device, the injecting unit may have an application surface, on which the one or more hollow first needles and the one or more second needles protrude toward the same side so as to be applied to a user’s skin together.
[0010]
According to one aspect of the device, the injecting unit may comprise a patch portion removably attached to the handle portion, the patch portion supporting the one or more second needles.
[0011]
According to one aspect of the device, the patch portion may comprise an adhesive layer configured to support the one or more second needles and adhere to a user’s skin.
[0012]
According to one aspect of the device, the patch portion may be configured to be detached from the handle portion while leaving the one or more hollow first needles on the handle portion.
[0013]
According to one aspect of the device, the patch portion may comprise one or more holes for allowing the one or more hollow first needles to pass therethrough.
[0014]
According to one aspect of the device, the handle portion may comprise a separation mechanism configured to operably separate the patch portion from the handle portion.
[0015]
According to one aspect of the device, the handle portion may have an inner space and the separation mechanism may be accommodated in the inner space.
[0016]
According to one aspect of the device, the water-soluble or water-dispersible material may be at least one selected from the group consisting of hyaluronic acid, monosaccharides, disaccharides, oligosaccharides, polysaccharides, dextrins, dextrans, polyethylene glycols, polyvinyl alcohols, poly(methylvinylether/maleic anhydride), polyvinylpyrrolidone, poly(methyl/vinyl ether/maleic acid), hydrolyzed collagen, and esters thereof, and poly(methyl/vinyl ether/maleic anhydride).
[0017]
According to one aspect of the device, the one or more hollow first needles may be removably attached to the handle portion.
[0018]
According to one aspect of the device, the lengths of the one or more hollow first needles and the one or more second needles may be between 20 pm and 1,000 pm.
[0019]
According to one aspect of the device, the fluid supply unit may comprise a fluid storage and a pressure regulator operably allowing the fluid to be supplied to the fluid passage.
[0020]
According to one aspect of the device, the fluid may be carbon dioxide gas.
BRIEF DESCRIPTION OF DRAWINGS
[0021]
Non-limiting and representative embodiments of the present invention will be explained in detail below referring to the attached drawings so that the present invention can be better understood.
[0022]
FIG. 1 is a plan view of the device 1 for cosmetic therapy according to the embodiment. [0023]
FIG. 2 is a front view of the device 1 for cosmetic therapy according to the embodiment. [0024]
FIG. 3 is a cross-sectional view of the device 1 for cosmetic therapy according to the embodiment along the line III-III in FIG. 2.
[0025]
FIG. 4 is a front view of the device 1 for cosmetic therapy according to the embodiment, without the patch portion 14.
[0026]
FIGS. 5 A and 5B are cross-sectional views of the device 1 for cosmetic therapy according to the embodiment along the line V-V in FIG. 4.
[0027]
FIGS. 6A to 6D are schematic views of how to use the device 1 for cosmetic therapy. BEST MODE FOR CARRYING OUT THE INVENTION
[0028]
Hereafter, the embodiments of the present invention will be described in a detailed manner. The XYZ coordinate system is defined as shown in the drawings, but this is not intended to limit the invention.
[0029]
A device for cosmetic therapy will be described below through an example. However, a fluid to be injected is not limited to CO2, but may be any fluid including a gas such as N2O, NO, O2, or H2, mixture gas, liquid, mixture liquid, medical solution, or other fluid, or a combination thereof.
<Device for Cosmetic Therapy>
[0030]
A device 1 for cosmetic therapy according to an embodiment will be described with reference to FIGS. 1 to 6D. FIG. 1 is a plan view of the device 1 for cosmetic therapy according to the embodiment.
[0031]
Referring to FIG. 1, the device 1 includes an injecting unit 10 and a gas supply unit 50. The injecting unit 10 and the gas supply unit 50 may be formed integrally or non-separably, or may be removably attached to each other. Although the gas supply unit 50 is detachable from the injecting unit 10 below, it is not necessarily required.
(Injecting unit 10)
[0032]
FIG. 2 is a front view of the device 1 for cosmetic therapy according to the embodiment. FIG. 3 is a cross-sectional view of the device 1 for cosmetic therapy according to the embodiment along the line III-III in FIG. 2. FIG. 4 is a front view of the device 1 for cosmetic therapy according to the embodiment, without the patch portion 14. FIGS. 5A and 5B are cross-sectional views of the device 1 for cosmetic therapy according to the embodiment along the line V-V in FIG. 4.
[0033]
The injecting unit 10 delivers CO2 gas therethrough into a skin S of a user and supplies active ingredients into the skin S. The injecting unit 10 includes a handle portion 12 and a patch portion 14.
(Handle portion 12)
[0034]
The handle portion 12 serves as a handgrip for the user in use. The handle portion 12 includes a main body 20, a gas nozzle 22, a hollow first needle 24, a pushing member 26 (an example of “separation mechanism”), a slide lever 28, and a connector 30,
[0035] The main body 20 is a body portion of the handle portion 12. The shape of the main body 20 can be determined depending on the application. For example, the main body 20 has a curved shape which is ergonomically easy to grip, as shown in FIG. 1. The direction in which the proximal end of the main body 20 is directed intersects with the direction in which the distal end of the main body 20 is directed.
[0036]
The main body 20 has an attachment surface 32 at the distal end thereof. The patch portion 14 is attached to the attachment surface 32 in use as shown in FIG. 1. The attachment surface 32 has a crescent-moon shape as shown in FIG. 4. The attachment surface 32 has openings which accommodate the gas nozzle 22 and pushers 38 of the pushing member 26, which will be described below.
[0037]
The main body 20 has inner space which accommodates a gas passage 34 (an example of “fluid passage”) and the pushing member 26, as shown in FIGS. 3, 5A, and 5B. The gas passage 34 is connected to the gas supply unit 50 and passes through the main body 20 from the proximal end thereof to the distal end thereof (i.e. the attachment surface 32) to supply CO2 gas from the gas supply unit 50 to the skin S. In FIG. 3, the gas passage 34 is a flexible tube member in the inner space of the main body 20. The gas passage 34 may at least partially be formed outside of the main body 20. Note that the gas passage 34 may be the inner space of the main body 20 itself, without a tube member.
[0038]
The gas nozzle 22 is an injection nozzle of CO2 gas from the gas passage 34. The gas nozzle 22 is provided on the attachment surface 32 and connected to the gas passage 34. The gas nozzle 22 has a cylindrical shape protruding on the gas nozzle 22.
[0039]
The first needle 24 is a hollow needle for injecting CO2 gas from the gas nozzle 22 into the skin S. The first needle 24 is attached to the gas nozzle 22 as shown in FIG. 3. For example, the first needle 24 is removably attached to the gas nozzle 22 so as to surround the outer surface of the gas nozzle 22. The first needle 24 has an inner passage in fluid communication with the gas passage 34 via the gas nozzle 22. The first needle 24 has a tapered cylindrical shape which is adapted to penetrate the skin S.
[0040]
The injecting unit 10 can have one or more first needles 24. For example, one first needle 24 at the center of the attachment surface 32 is shown in FIGS. 1 and 2. However, the number of the first needle 24 is not limited to this embodiment. The first needle 24 may also be positioned at the end of the attachment surface 32. It should be noted that the injecting unit 10 does not have to have multiple first needles 24 since a single first needle 24 is enough to provide the sufficient amount of CO2 gas into the skin S in use because of fast and effective diffusion of CO2 gas.
[0041]
The material of the first needle 24 is, for example, metal such as stainless steel, silicone compound, biodegradable polymer, thermoplastic resin, water-soluble polymer, etc. Biodegradable polymer is, for example, polyglycolic acid (PGA) or polylactic acid (PLA). Thermoplastic resin is, for example, medical silicone, polymer materials, ultraviolet curing resins, polydimethylsiloxane, polycarbonate, or cyclic olefin copolymer. Water-soluble polymer is, for example, carboxymethyl cellulose (CMC), methyl cellulose (MC), hydroxypropyl cellulose (HPC), hydroxypropyl methyl cellulose (HPMC), polyvinyl alcohol (PVA), polyacrylic acid-based polymer, polyacrylamide (PAM), polyethylene oxide (PEO), purulan, alginate, pectin, chitosan, chitosan succinamide, or oligochitosan.
[0042]
The length of the first needle 24 can be determined depending on the target depth. For example, the first needle 24 has a length between 20 pm and 1,000 pm, and for cosmetic application, the first needle 24 may have a length between 50 pm and 300 pm to deliver the gas into a shallow layer of the skin S such as stratum comeum or epidermis. Thereby, the injecting unit 10 with the first needle 24 having a length between 50 pm and 300 pm can reduce the user’s pain since the first needle 24 is inserted into a shallow layer such as stratum comeum or epidermis, but not into deep layers such as dermis. If the length of the first needle 24 is too large, it would cause pain. On the other hand, if the length of the first needle 24 is too small, it would be difficult to insert the first needle 24 into the skin S. However, the length of the first needle 24 is not limited to this embodiment.
[0043]
The outer diameter of the first needle 24 can be determined depending on the application. For example, the outer diameter (e.g. the maximum outer diameter) of the first needle 24 is between 40 pm and 200 pm, and preferably between 50 pm to 120 pm for cosmetic application of gas delivery without pain or severe discomfort. For example, the outer diameter of the first needle 24 may be no less than 60 pm, 70 pm, 80 pm, 90 pm, or 100 pm, and no more than 190 pm, 180 pm, 170 pm, 160 pm, or 150 pm. If the outer diameter of the first needle 24 is too small, the first needle 24 would be easily broken during the insertion into the skin S. On the other hand, if the outer diameter of the first needle 24 is too large, it would cause pain. In this embodiment, the first needle 24 is a microneedle.
[0044]
The pushing member 26 is a separation mechanism to push off the patch portion 14 from the attachment surface 32. The slide lever 28 is an operational switch which is used in combination with the pushing member 26. The pushing member 26 is movably provided in the inner space of the main body 20. The slide lever 28 is connected to one end of the pushing member 26 and exposed on the outer surface of the main body 20. The slide lever 28 can slide on the outer surface of the main body 20 between a normal position in FIG. 5A and a pushing position in FIG. 5B. The pushing member 26 moves along the Z direction together with the movement of the slide lever 28. The pushing member 26 includes a transfer member 36 and three pushers 38.
[0045]
The transfer member 36 transfers the user’s force on the slide lever 28 to the pushers 38. One end of the transfer member 36 is connected to the slide lever 28 while the other end is trifurcate and connected to each of the pushers 38. When the user slides the slide lever 28 from the normal position to the pushing position, the transfer member 36 moves from the normal position to the pushing position as well. The inner space of the main body 20 is larger than the size of the transfer member 36 such that the transfer member 36 can move between the normal position and the pushing position.
[0046] The pushers 38 contact the patch portion 14 on the attachment surface 32 and push off the patch portion 14 from the attachment surface 32. The number, shape of the pushers 38 can be determined depending on the application. In this embodiment, three pushers 38 with an oval plate shape are provided at the trifurcate end of the transfer member 36 as shown in FIG. 4 so as to provide the pushing member 26 with a plurality of pushing points. In the normal position in FIG. 5A, the pushers 38 are housed in the openings on the attachment surface 32. In the pushing position in FIG. 5B, the pushers 38 get out of the openings of the attachment surface 32 to push the patch portion 14.
[0047]
However, the present invention is not limited to this embodiment. Any other mechanism is available to separate the patch portion 14 from the handle portion 12.
[0048]
The connector 30 connects the main body 20 to the gas supply unit 50 to allow the gas supply unit 50 to supply CO2 gas into the gas passage 34. The connector 20 is a cylindrical portion provided on the proximal end of the main body 20 in communication with the gas passage 34. Any known connecting mechanism is possible for the connector 30. Note that if the gas supply unit 50 is non-separably formed with the injecting unit 10, the connector 30 may be omitted.
(Patch portion 14)
[0049]
The patch portion 14 is applied to the skin S of the user and injects active ingredients into the skin S. The patch portion 14 is attached to the attachment surface 32 at the distal end of the handle portion 12. The patch portion 14 has a crescent-moon shape similar to that of the attachment surface 32 as shown in FIG. 2. For example, the patch portion 14 has substantially the same shape as that of the attachment surface 32 in the XY plane. The crescent-moon shape is suitable for application to skin under an eye. The patch portion 14 includes an adhesive layer 40, a separation layer 42, and second needles 44.
[0050]
The adhesive layer 40 is directly applied to and adheres to the skin S of the user. One surface of the adhesive layer 40 which faces the skin S of the user serves as an application surface of the injecting unit 10. The adhesive layer 40 is at least partially made of any kind of adhesive. For example, the adhesive layer 40 is of typical medical adhesive, which can be made from a variety of materials, such as natural rubber or synthetic rubber including hydrocolloids, polyacrylates, hydrogels, polyurethanes, or silicone.
[0051]
The separation layer 42 facilitates separation of the patch portion 14 from the attachment surface 32. The separation layer 42 is provide between the adhesive layer 40 and the attachment surface 32 and bonded to the adhesive layer 40. The separation layer 42 can be bonded to, e.g. adhere to, the attachment surface 32 less strongly than to the adhesive layer 40. For example, the separation layer 42 is made of silicone material or hydro gel.
[0052]
A needle hole 46 for accommodating the first needle 24 is formed in the adhesive layer 40 and the separation layer 42. The needle hole 46 allows the first needle 24 on the attachment surface 32 to pass therethrough and protrude from the adhesive layer 40 toward the skin S. Although the needle hole 46 is formed at the center of the adhesive layer 40 and the separation layer 42 in FIG. 3, it depends on the position of the first needle 24.
[0053]
The second needles 44 are inserted into the skin S and can at least partially be dissolved or dispersed into the skin S. The second needles 44 are provided on and protrude from the adhesive layer 40 at the distal end of the handle portion 12. The second needles 44 are positioned adjacent to the first needle 24 on the adhesive layer 40. The second needles 44 are supported by the patch portion 14, specifically by the adhesive layer 40.
[0054]
The number, density, and arrangement of the second needles 44 can be determined depending on the application. The patch portion 14 can have one or more second needles 44. For example, four second needles 44 around one first needle 24 are shown in FIGS. 1 and 2. However, the number of the second needles 44 is not limited to this embodiment. The first needle 24 may also be positioned at the side of the adhesive layer 40, not at the center surrounded by the second needles 44.
[0055]
The second needles 44 are at least partially, preferably entirely, made of water-soluble or water-dispersible material, e.g. water-soluble or water-dispersible polymer. For example, the water-soluble or water-dispersible material is at least one selected from the group consisting in hyaluronic acid, monosaccharides, disaccharides, oligosaccharides, polysaccharides, dextrins, dextrans, polyethylene glycols, polyvinyl alcohols, poly(methylvinylether/maleic anhydride), polyvinylpyrrolidone, poly(methyl/vinyl ether/maleic acid) (PMVE/MA), hydrolyzed collagen, and esters thereof, and poly(methyl/vinyl ether/maleic anhydride) (PM VE/M AH). Thus, when the second needles 44 are inserted into the skin S, the water-soluble or water-dispersible material of the second needles 44 is dissolved in water or bodily fluid.
[0056]
Each second needle 44 has, for example, a pointed and tapered shape so as to penetrate the skin S. The second needles 44 may have a solid body or a hollow body.
[0057]
The length and outer diameter of the second needles 44 can be determined depending on the application. For example, the second needles 44 have substantially the same or similar size as the first needle 24. For example, as with the first needle 24, the second needles 44 may have a length between 20 pm and 1,000 pm, and for cosmetic application, the second needles 44 may have a length between 50 pm and 250 pm to deliver the gas into a shallow layer of the skin S such as stratum comeum or epidermis. Moreover, the second needles 44 may have an outer diameter (e.g. the maximum outer diameter) between 40 pm and 200 pm. In this embodiment, the second needles 44 are microneedles. However, the length and outer diameter of the second needles 44 are not limited to this embodiment.
(Gas supply unit 50)
[0058]
Returning back to FIG. 1, the gas supply unit 50 stores CO2 gas inside and supplies CO2 gas into the injecting unit 10. The gas supply unit 50 includes a gas storage 52 and a pressure regulator 54.
[0059]
The gas storage 52 is a cartridge for storing CO2 gas in high pressure (e.g. more than several MPa or tens MPa) with variation by the usage of the gas. A conventional and exchangeable gas cylinder can be used as the gas storage 52. For example, the volume of the gas storage 52 is 10 mLto 20 mL.
[0060]
The gas storage 52 is removably connected to the pressure regulator 54. The pressure regulator 54 delivers CO2 gas from the gas storage 52 to the gas passage 34 and regulates the pressure of the delivered CO2 gas. The pressure regulator 54 controls the pressure of CO2 gas, which is to be delivered to the gas passage 34, to be constant and reduces the pressure of CO2 gas from the gas storage 52 down to a supply pressure for the gas passage 34. The supply pressure can be determined depending on the application. For example, the supply pressure is between 0.15 MPa (1.5 bar) and 0.4 MPa (4 bar). Thereby, the pressure regulator 54 can maintain the pressure of CO2 gas consistently and steadily supply the moderate pressure of CO2 gas to the gas passage 34.
[0061]
As shown in FIG. 1, the pressure regulator 54 includes an injection switch 56 and a gas storage connector 58.
[0062]
The injection switch 56 is a unit for the user to start/stop the injection of CO2 gas into the gas passage 34. For example, the injection switch 56 may be embodied as a manual button as shown in FIG. 1. For example, the injection switch 56 can be configured as a button to start the injection of CO2 gas into the gas passage 34 when the user presses the injection switch 56 and to stop the injection when the user releases the injection switch 56.
[0063]
A one-way valve (not shown) is provided at one end of the pressure regulator 54 to be connected to the injecting unit 10. The one-way valve allows CO2 gas to pass therethrough only in one direction from the pressure regulator 54 to the gas passage 34. Thereby, the one way valve can prevent counter flow of CO2 gas from the gas passage 34 to the pressure regulator 54.
[0064]
The gas storage connector 58 connects the gas storage 52 to the pressure regulator 54. Any known connecting mechanism is possible for the gas storage connector 58.
<Method of Using the Device for Fluid Injection Therapy>
[0065]
A method of using the device 1 according to the present embodiment will be discussed below, with reference to FIGS. 6A to 6D.
[0066]
The user first attaches the first needle 24 to the gas nozzle 22 of the handle portion 12. Next, the user attaches the patch portion 14 to the attachment surface 32 such that the first needle 24 passes through the needle hole 46. The user also attaches the injecting unit 10 to the gas supply unit 50 to assemble the device 1. Then, the user grips the main body 20 and applies the patch portion 14 to the skin S to insert the first needle 24 and the second needles 44 on the adhesive layer 40 into the skin S.
[0067]
The first needle 24 and the second needles 44 penetrate the skin S and the adhesive layer 40 adheres to the skin S as shown in FIG. 6A. The user can operate the injection switch 56 to supply CO2 gas from the gas storage 52 through the gas passage 34 into the skin S to perform carboxytherapy. At the same time, active ingredients of the second needles 44 are progressively dissolved or dispersed into the skin S, e.g. stratum comeum and/or epidermis, so that mesotherapy is performed along with carboxytherapy. CO2 gas may diffuse into deeper layers of the skin S than the active ingredients.
[0068]
After the completion of injecting the predetermined amount of CO2 gas into the skin S, the user operates the slide lever 28 to actuate the pushing member 26. The slide lever 28 slides from the normal position (FIG. 6A) to the pushing position (FIG. 6B). In response to the slide action of the slide lever 28, the transfer member 36 moves in the +Z direction to transfer the user’s force on the slide lever 28 to the pushers 38, and the pushers 38 push the patch portion 14 toward the skin S. As a result, the separation layer 42 is separated from the attachment surface 32 and the patch portion 14 is left on the skin S with the second needles 44 staying in the skin S. On the other hand, the first needle 24 leaves the skin S together with the handle portion 12 as shown in FIG. 6B.
[0069]
After pushing off the patch portion 14 from the handle portion 12, the slide lever 28 goes back to the normal position along with the pushing member 26 as shown in FIG. 6C. The patch portion 14 the adhesive layer 40 continues to adhere to the skin S with the second needles 44 left in the skin S and the dissolution of the second needles 44 continues.
[0070]
Then, the user detaches the first needle 24 from the handle portion 12 as shown in FIG. 6D. The user can detach the first needle 24 manually or by means of any detachment mechanism, e.g. like the slide lever 28. Accordingly, the user can detach the patch portion 14 and the first needle 24 in two-step actions, i.e. the user can remove the patch portion 14 from the handle portion 12 in the first action and then remove the first needle 24 from the handle portion 12 in the second action. The user may also detach the gas supply unit 50 from the handle portion 12 or detach the gas storage 52 from the gas supply unit 50. After the completion of mesotherapy, the user removes the patch portion 14 from the skin S.
[0071]
The patch portion 14 and the first needle 24 may be entirely a single-use unit and disposable. Since the handle portion 12 except for the first needle 24 can be used repeatedly by disposing the patch portion 14 and the first needle 24, it is cost-effective. It is also possible to use the patch portion 14 and the first needle 24 multiple times as long as they are subject to effective sterilization.
[0072]
By means of the device 1 , the user can perform both carboxytherapy and mesotherapy. The device 1 can be used to treat dark circles on the skin S and may also be used for other application such as wrinkle and fine line reduction, scar management, stretch mark reduction, etc. In particular, for dark circle reduction, hyaluronic acid is effective. However, any other water-soluble or water-dispersible active ingredients may be used.
<Effects>
[0073]
According to the device 1, it is possible to inject CO2 gas along with active ingredients such as hyaluronic acid in a single gesture. The user can easily perform simultaneous inj ection of CO2 gas and active ingredients by the device 1. This may lead to two different benefit for hydration and dark circle reduction by a single treatment. Moreover, this can save time and reduce burdens to the user, and can also lead to more synergistic effects between carboxytherapy and mesotherapy during the simultaneous injection. This increases treatment efficacy and long-lastingness. The CO2 flow into skin tissues may help the active ingredients to penetrate and spread into tissues for a better filler/hydration action. This effect is different from the conventional sequential procedure of gas injection and active ingredient injection.
[0074]
According to one embodiment, the patch portion 14 and the first needle 24 are removable from the handle portion 12. Thereby, the handle portion 12 can easily be reused.
[0075]
According to one embodiment, the patch portion 14 can be separated from the handle portion 12 and adhere to the skin S of the user. Thereby, the user does not have to hold the device 1 during the treatment.
[0076]
According to one embodiment, the patch portion 14 can be detached from the handle portion 12 while leaving the first needle 24 on the handle portion 12. Thereby, non-water- soluble first needle 24 can be removed while water-soluble or water-dispersible second needles 44 stay on the skin S to allow the active ingredients to continue to spread.
[0077]
According to one embodiment, the patch portion 14 comprises a needle hole 46 for allowing the first needle 24 to pass therethrough. Thereby, the first needle 24 protrudes from the adhesive layer 40 together with the second needles 44, and thus the patch portion 14 can support both the first needle 24 and the second needles 44 to be stably applied to the skin S.
[0078]
According to one embodiment, the handle portion 12 has an inner space and the pushing member 26 is accommodated in the inner space. Thereby, the outer structure of the device 1 can be simplified so as to facilitate the handling of the device 1.
<Example>
[0079]
Tests were performed using a device comprising a CO2 cartridge, a pressure regulator, an injection button, and a single hollow microneedle tip. CO2 bubbles were observed into the skin using Optical Coherence Tomography after injection. Accordingly, it has been proved to be feasible to inject CO2 gas into the skin with hollow microneedles.
[0080]
After the CO2 injection, impact on surrounding tissues was checked using histology. No major tissue damage was observed and tissue integrity was kept.

Claims

1. A device for cosmetic therapy, comprising: an injecting unit comprising: a handle portion comprising a fluid passage, one or more hollow first needles at an end of the handle portion, the one or more hollow first needles having an inner passage in fluid communication with the fluid passage, and one or more second needles including water-soluble or water-dispersible material, the one or more second needles being separable from the handle portion; and a fluid supply unit configured to supply a fluid to the fluid passage.
2. The device according to Claim 1, wherein the injecting unit has an application surface, on which the one or more hollow first needles and the one or more second needles protrude toward the same side so as to be applied to a user’s skin together.
3. The device according to Claim 1 or 2, wherein the injecting unit comprises a patch portion removably attached to the handle portion, the patch portion supporting the one or more second needles.
4. The device according to Claim 3, wherein the patch portion comprises an adhesive layer configured to support the one or more second needles and adhere to a user’s skin.
5. The device according to Claim 3 or 4, wherein the patch portion is configured to be detached from the handle portion while leaving the one or more hollow first needles on the handle portion.
6. The device according to any one of Claims 3 to 5, wherein the patch portion comprises one or more holes for allowing the one or more hollow first needles to pass therethrough.
7. The device according to any one of Claims 3 to 6, wherein the handle portion comprises a separation mechanism configured to operably separate the patch portion from the handle portion.
8. The device according to Claim 7, wherein the handle portion has an inner space and the separation mechanism is accommodated in the inner space.
9. The device according to any one of Claims 1 to 8, wherein the water-soluble or water- dispersible material is at least one selected from the group consisting of hyaluronic acid, monosaccharides, disaccharides, oligosaccharides, polysaccharides, dextrins, dextrans, polyethylene glycols, polyvinyl alcohols, poly(methylvinylether/maleic anhydride), polyvinylpyrrolidone, poly(methyl/vinyl ether/maleic acid), hydrolyzed collagen, and esters thereof, and poly(methyl/vinyl ether/maleic anhydride).
10. The device according to any one of Claims 1 to 9, wherein the one or more hollow first needles are removably attached to the handle portion.
11. The device according to any one of Claims 1 to 10, wherein the lengths of the one or more hollow first needles and the one or more second needles are between 20 pm and 1 ,000 pm.
12. The device according to any one of Claims 1 to 11, wherein the fluid supply unit comprises a fluid storage and a pressure regulator operably allowing the fluid to be supplied to the fluid passage.
13. The device according to any one of Claims 1 to 12, wherein the fluid is carbon dioxide gas.
PCT/JP2022/020898 2021-05-20 2022-05-13 Device for cosmetic therapy WO2022244855A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP2021085379A JP2022178516A (en) 2021-05-20 2021-05-20 Device for cosmetic therapy
JP2021-085379 2021-05-20
FR2107808 2021-07-20
FR2107808A FR3125428B1 (en) 2021-07-20 2021-07-20 DEVICE FOR COSMETIC THERAPY

Publications (1)

Publication Number Publication Date
WO2022244855A1 true WO2022244855A1 (en) 2022-11-24

Family

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