EP2968885A1 - Appareil et procédé pour le rajeunissement tissulaire - Google Patents

Appareil et procédé pour le rajeunissement tissulaire

Info

Publication number
EP2968885A1
EP2968885A1 EP13877866.7A EP13877866A EP2968885A1 EP 2968885 A1 EP2968885 A1 EP 2968885A1 EP 13877866 A EP13877866 A EP 13877866A EP 2968885 A1 EP2968885 A1 EP 2968885A1
Authority
EP
European Patent Office
Prior art keywords
treatment
skin
target area
hollow needles
needles
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.)
Withdrawn
Application number
EP13877866.7A
Other languages
German (de)
English (en)
Other versions
EP2968885A4 (fr
Inventor
Alexandra ALVAREZ
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.)
Plum Systems Co
Original Assignee
Plum Systems Co
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 Plum Systems Co filed Critical Plum Systems Co
Publication of EP2968885A1 publication Critical patent/EP2968885A1/fr
Publication of EP2968885A4 publication Critical patent/EP2968885A4/fr
Withdrawn legal-status Critical Current

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
    • 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
    • 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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • 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
    • A61M2005/006—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 for gases, e.g. CO2
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0225—Carbon oxides, e.g. Carbon dioxide
    • 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
    • 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
    • A61M5/46—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 having means for controlling depth of insertion

Definitions

  • This application generally relates to tissue repair in human subjects.
  • the invention relates to devices and methods for localized administration of carbon dioxide.
  • Carboxytherapy also known as carbon dioxide (C0 2 ) therapy or CDT is a safe and effective therapy that can improve the appearance of treated skin.
  • C0 2 carbon dioxide
  • CDT is a safe and effective therapy that can improve the appearance of treated skin.
  • carboxytherapy has found applications in the reduction of skin irregularities, wrinkle reduction and as a complementary treatment to other forms of aesthetic and therapeutic treatments, such as liposuction.
  • carboxytherapy is a non-surgical method, but which requires a treatment by a medical professional.
  • C0 2 is inserted using needles into the subcutaneous tissue through very small needles, for example 30G needles. From the injection point, the C0 2 diffuses into adjacent tissues. While carboxytherapy uses innocuous amounts of inert C0 2 gas, the use of needles as a the mode of application requires that a medical professional to apply the treatment.
  • One aspect of the present invention relates to a method of applying carboxytherapy to a subject in need of such treatment, comprising the steps of: contacting a target body surface of said subject with a treatment device comprising: a plurality of hollow needles attached to a contact surface of a housing; and a C0 2 source in fluid communication with at least one of said plurality of hollow needles; applying pressure to said housing such that one or more of the plurality of hollow needles penetrate an epidermis or an outermost layer of cell in said target body surface;applying a therapeutic amount of C0 2 to said subject through said plurality of hollow needles; and removing said plurality of hollow needles from said target body surface.
  • Another aspect of the present invention relates to a method for treating hair loss in a target area of a subject, comprising: introducing an effective amount of C0 2 into subcutaneous tissue of said target area for a sufficient period of time, wherein said effective amount of C0 2 is introduced into said target area with a plurality of hollow needles that puncture epidermis of said target area and release C0 2 at a desired rate within said subcutaneous tissue.
  • Another aspect of the present invention relates to a method for treating a skin condition in a target area of a subject, comprising: introducing an effective amount of C0 2 into subcutaneous tissue of said target area for a sufficient period of time, wherein said effective amount of C0 2 is introduced into said target area with a plurality of hollow needles that puncture epidermis of said target area and release CC1 ⁇ 2 at a desired rate within said subcutaneous tissue.
  • Another aspect of the present invention relates to a method for promoting wound healing in a target area of a subject, comprising: introducing an effective amount of C0 2 into subcutaneous tissue of said target area for a sufficient period of time, wherein said effective amount of C0 2 is introduced into said target area with a plurality of hollow needles that puncture epidermis of said target area and release C0 2 at a desired rate within said subcutaneous tissue.
  • Yet another aspect of the present invention relates to a disposable skin treatment device, comprising a plurality of hollow needles attached to a surface of a base, wherein said hollow needles having diameters in the range of 0.1-0.5 mm and lengths in the range of 0.4-2.5 mm and wherein said base is attachable to a handheld device to form a fluid communication between at least one of said plurality of hollow needles; wherein at least one of said plurality of hollow needles comprises a sharp end capable of penetrating human epidermis under hand pressure.
  • FIG. 1 depicts the exterior contact surface of an exemplary application device.
  • FIG. 2 shows the interior of the contact surface of FIG. 1.
  • FIG. 3 shows the valves of the exemplary application device of FIG. 1.
  • FIG. 4 shows the handle and controls of the exemplary application device of
  • FIG. 5 is a side view of the exemplary application device of FIG. 1 showing the C0 2 supply tube.
  • FIG. 6 shows another exemplary embodiment of an application device having microneedles affixed thereto.
  • FIG. 7 is an illustration of the penetration of the skin by the microneedles of the device.
  • FIG. 8 depicts an exemplary configuration for the microneedles in the base element.
  • FIG. 9 depicts another exemplary configuration for the microneedles in the base element.
  • the present invention provides improved methods and devices to apply carboxytherapy to an area of a patient.
  • the device includes a treatment device fittable with a microneedle/base element where a plurality of the microneedles are in fluid communication with a source of C0 2 .
  • a source of C0 2 a source of C0 2 .
  • the device is placed on the surface of the skin or scalp of the patient as described below.
  • administering to the skin in need of such treatment means contacting (e.g., by use of the hands or an applicator) the area of skin in need such treatment.
  • These features may be present on the face, such as under or adjacent the eyes, nose, forehead, cheeks, jowls, and neck, as well as other areas of the body such as the arms, chest, back, shoulder, belly (e.g., stretch marks), and legs (e.g., cellulite).
  • treating or “treatment” of a skin disorder means the treatment (e.g., complete or partial reduction or elimination of symptoms and/or cure) and/or prevention or inhibition of the skin disorder.
  • skin disorder or “skin condition” means a disease, disorder, or defect of the skin.
  • needle and “microneedle” refer to a piercing element suitable for passing gas therethrough that is also suitable to pierce the skin of a patient or subject in accordance with a carboxytherapy method.
  • the terms are
  • microneedles means a collection of microneedles arranged for use in the device and methods herein. Such plurality of microneedles must be securably attached to the base material so as to allow suitable insertion into the skin of a patient and also to allow application of other forms of treatment.
  • suitable materials for use as the microneedles herein can include one or more of metals and metal alloys such as, for example, stainless steel, gold, iron, steel, tin, zinc, copper, platinum, aluminum, germanium, zirconium, titanium and titanium alloys containing molybdenum and chromium, metals or non-metals plated with, gold, rhodium, iridium, titanium, platinum, silver, silver halides, and alloys of these or other metals.
  • metals and metal alloys such as, for example, stainless steel, gold, iron, steel, tin, zinc, copper, platinum, aluminum, germanium, zirconium, titanium and titanium alloys containing molybdenum and chromium, metals or non-metals plated with, gold, rhodium, iridium, titanium, platinum, silver, silver halides, and alloys of these or other metals.
  • the microneedles used in the present invention can have substantially straight or substantially tapered shafts.
  • the diameter of the microneedles can be larger at the base end of the microneedle to taper to a point at the end distal the base.
  • the microneedles can be circular or semi-circular or any other suitable cross- sectional shape.
  • the cross-section of the microneedle can be polygonal (e.g., star-shaped, square, triangular, rectangular), oblong, or another shape.
  • the microneedles must be suitable to provide carboxytherapy treatment to a patient in need of such treatment.
  • the microneedles are therefore in fluid communication with a source of C0 2 when the microneedle/base implantationlement arrangement is in secure attachment with the treatment device as discussed further herein.
  • microneedles When secured to the base material, microneedles can be oriented substantially perpendicular or at an angle thereto. Still further, the microneedles can be oriented substantially perpendicular to the base material. In some aspects, a configuration of microneedles can comprise an arrangement of comprising different microneedle orientations, heights, or other parameters. [0031] Generally, the microneedles should have the mechanical strength to resist distortion (such as bending) while being inserted into the skin and while being removed one or more times.
  • the microneedles can be made from medical-grade steel, such as an acupuncture-type needle, and be from about 0.1 to about 0.5 mm in diameter. Each microneedle can be from about 0.4 to about 2.1 mm in length. In aspect of the invention, each microneedle is from about 0.5 mm and 1.1 mm. Still further, the length of each microneedle can be from about 0.1 , 0.3, 0.5, 0.7, 1.0, 1.5, 2.0 or 2.5 mm in length, where any one of these lengths can be used individually or in combination in secure attachment to a base material and to be in fluid communication with a source of C02 as discussed elsewhere herein.
  • microneedles must be securely attached to the base material.
  • the microneedles and a base material to which they are attached comprises a single, disposal one time use unit, otherwise known as a "consumable.”
  • Use of a consumable configuration that securely attaches to a reusable treatment device can facilitate maintenance of a sterile treatment regime, as well as a treatment that is customizable to each patient.
  • the base material to which the microneedles are securely fastened to provide a microneedle/base element can comprise a rigid material that is sufficiently stiff so as to assist in directing the attached microneedles through a patient's skin.
  • the microneedles and base material can be configured as a single unit, such as from stamping of a stainless steel using precision methods that will create needled projections from a flat or substantially flat base material.
  • Use of a metallic material can facilitate application of electrical stimulation and/or heat treatment to a patient in conjunction with carboxytherapy treatment as discussed elsewhere herein.
  • the microneedles and base materials are comprised of the same material.
  • the base material can comprise flexible material to allow the base material to generally conform to the contours of the skin and to adapt to deformations that may occur when the microneedles are inserted.
  • microneedles can be securely attached to the base material such as by embedding them into a polymeric material and then applying a suitable adhesive so as to ensure attachment.
  • a flexible surface can facilitates more consistent penetration during use, since penetration can be limited by deviations in the attachment surface.
  • the depth of C0 2 infusion will vary according to the treatment, for example, the treatment can be from about 2 to about 20 mm. Microneedle length will be substantially equal to the depth of infusion
  • One aspect of the present application relates to a skin treatment device that is capable of effectively delivering a treatment fluid into the cutaneous and/or subcutaneous tissue of a target body area.
  • a benefit of the skin treatment device of the present application is that multiple insertions of the treatment fluid below the skin surface can be effected simultaneously by a practitioner at a controlled flow rate.
  • the treatment fluid is a gas or a mixture of gases.
  • the fluid is a liquid.
  • the fluid is a gasified liquid.
  • the fluid is C0 2 gas.
  • the skin treatment device of the present application comprises a housing having a contact surface.
  • the contact surface comprises a plurality of hypodermic needles for penetrating the skin and delivering the treatment fluid into or under the skin layer.
  • the plurality of needles on the contact surface are in fluid communication with the treatment fluid source to allow delivery of the treatment fluid from the treatment fluid source into or through the skin.
  • the plurality of needles protrude between about 0.1 mm and about 10.0 mm from the contact surface.
  • the plurality of needles protrude between about 0.15 mm and about 4.0 mm from the contact surface.
  • the plurality of needles protrude between about 0.3 mm and about 3.0 mm from the contact surface.
  • the plurality of needles protrude between about 0.3 mm and about 2.0 mm from the contact surface.
  • the needles have a length of, or about, 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.
  • the needle lengths can control the depth levels and, thus, the exact location of where the treatment fluid will be delivered.
  • the needles on the contact surface of the device are all the same length. In other embodiments, the needles on the contact surface of the device are of mixed lengths in order to protrude different depths into or through the body tissue.
  • Needles can be manufactured from stainless steel, and the needle fracture force is hundreds of times greater than the skin insertion force.
  • the gauge of the needles should be small enough to minimize pain and scarring to the patient.
  • the size of the needles is sufficient to overcome natural resistance to pierce the stratum corneum.
  • the needles are between about 26 gauge and about 36 gauge. In some further embodiments, the needles are between about 27 gauge and about 34 gauge. In other further embodiments, the needles are between about 28 gauge and about 33 gauge. In still other further embodiments, the needles are between about 29 gauge and about 32 gauge. In yet further embodiments, the needles are between about 30 gauge and about 32 gauge.
  • the needles are selected from a gauge of 26, 26s, 27, 28, 29, 30, 31 , 32, 33, 34, 35 or 36. In some other embodiments, the needles are microneedles. In some embodiments, the needles on the contact surface of the device are all the same gauge. In other embodiments, the needles on the contact surface of the device are of mixed gauges in order to deliver different volumes of the treatment fluid to different areas of the body tissue.
  • the size and spacing of the needles may vary depending on the needs of the treatment regimen.
  • the needles are spaced at about 2, 3, 4, 5, 6, 7, 8, 9, 10 mm apart from each other.
  • the distance between any two needles may be constant or variable.
  • the needles are arranged in an average density of 1 , 2, 3, 4, 5, 6, 7, 8, 9 or 10 needles per cm 2 of the contact surface.
  • the average needle density of the contact surface is defined as the total number of needles divided by the total surface area of the contact surface.
  • the contact surface has a total area of about 10-500 cm 2 , about 20-400 cm 2 or about 40-200 cm 2 . In other embodiments, the contact surface has a total area of about 20 cm 2 , about 40 cm 2 , about 60 cm 2 , about 80 cm 2 , about 100 cm 2 , about 150 cm , about 200 cm , about 250 cm , about 300 cm , about 350 cm , about 400 cm , about 450 cm 2 or about 500 cm 2 .
  • the contact surface of the skin treatment device is detachable from the housing and contact surfaces of various sizes and shapes can be attached to the skin treatment device depending on the treatment area and treatment method. In some embodiments, the contact surface has a degree of flexibility that will allow the contact surface to adjust to contours of the body surface to be treated, such as the curvature of the head, thigh etc.
  • the contact surface is in the form of a roller.
  • the roller has a cylindered shape with a diameter of about 2, 3, 4, 5, 6, 7, 8, 9 or 10 cm and a width (i.e., the distance from side end to side end of the roller) of about 4, 6, 8, 10, 12, 14, 16, 18, 20 cm.
  • the roller can have a degree of flexibility that will allow the roller to adjust to contours of the body surface to be treated, such as the curvature of the head, thigh etc.
  • the housing further comprises a one or more valves that control the flow rate of the treatment fluid.
  • the housing further comprises a battery.
  • the house further comprises a control module that controls the fluid flow rate through the one or more valves.
  • the housing further comprises a fluid inlet to be connected to a fluid source.
  • the housing comprises a fluid tank located within the housing.
  • the contact surface is removable and disposable.
  • the skin treatment device is designed for single use.
  • FIGS. 1-5 show an embodiment of the skin treatment device 100 designed to introduce C0 2 into a skin tissue of a patient.
  • FIG. 1 depicts the contact surface 1 10 of a housing 120 (see FIG. 5).
  • the contact surface 1 10 is composed of a flexible material such as, but not limited to, polyethylene, polyurethane, silicon or rubber.
  • the contact surface 1 10 is composed of a rigid polylmer material such as, but not limited to, polystyrene, polycarbonate or polyvinyl chloride.
  • the contact surface 1 10 is composed of a rigid polymer material coated with a layer of flexible material.
  • the contact surface 1 10 is composed of a biodegradable material.
  • the biodegradable material may be selected from any suitable biodegradable material, or from mixtures of two or more thereof. Suitable materials include, but are not limited to, cellulose and cellulosic derivatives, polymers of lactic acid (PLA) and its derivatives, polymers of hydroxyalkanoates (PHAs), biodegradeable copolyesters and polycaprolactones.
  • the biodegradable material may comprise a true biopolymer (PHA or PLA for example), or suitably biodegradable synthetic polymers or suitable mixtures of two or more thereof.
  • nodules 1 12 present on protuberances 1 14 in the contact surface 1 10, which is located on the exterior side of a detachable head 122 of the housing 120.
  • the piercing tips of the needles Prior to charging the device with the C0 2 gas, the piercing tips of the needles are hidden in the nodules.
  • the contact surface 1 10 is the only part of the skin treatment device 100 that makes physical contact with the body of the patient, in some embodiments, the detachable head 122 of the housing 120 is disposable. In other embodiments, the detachable head 122 of the housing 120 is sterilizable.
  • the nodules can be used to stimulate, or massage, the skin of the patient prior to injection of the C0 2 gas.
  • this stimulation or massage of the skin with the nodules serves to mitigate the pain of the needles piercing the skin.
  • FIG. 2 depicts the interior side 124 of the detachable head 122 of the housing 120.
  • the interior side 124 of the detachable head 122 comprises chambers through which the C0 2 gas flows to the needles 1 12 embedded in the contact surface 1 10.
  • the interior side 124 of the detachable head 122 has multiple C0 2 distribution chambers 126 that promotes more even pressure distribution of the C0 2 gas to all of the needles.
  • the C0 2 distribution chambers 126 contains apertures or nodules 125 and are sealed against the base 128 of the housing 120 by rubber seals 127.
  • FIG. 3 shows the base 128 of the housing 120.
  • the base 128 comprises valves 129 that contact apertures or nodules 125 in the interior side 124 of the detachable head 122.
  • the valves 129 are pin valves that contact apertures/nodules 125. Opening the valves 129 allows the flow of C0 2 gas into the chambers 126 and through the needles 1 12 embedded in the contact surface 1 10 into or through the target skin tissue of the patient.
  • FIG. 4 shows a control module 130 of the skin treatment device 100.
  • the control module 130 comprises controls or buttons 132 for opening and closing the valves 129, allowing or stopping the flow of C0 2 gas through to the needles 112.
  • the control module 130 may further comprises one or more lights 134.
  • At least one light indicates the readiness status of the device for application of C02. In some embodiments, at least one light indicates the power charge status of the device.
  • the housing further comprises one or more batteries for powering the device. In some further embodiments, the battery is rechargeable. In alternative further embodiments, the battery is replaceable.
  • the skin treatment device 100 is powered by a cord that attaches to a separate control device or by an electrical cord to an external power source.
  • the housing 120 further comprises a means for establishing fluid communication of the C0 2 source with the needles that deliver the C0 2 into or through the body tissue. In some embodiments, the C0 2 source is an external tank or reservoir.
  • the C0 2 source is a pressurized C0 2 cartridge that inserts into, or attaches to, the housing 120 of the device.
  • the C0 2 cartridge is disposable, being replaceable for each new patient.
  • the controls or buttons 132 or lights 134 are not located on the top of the device, but can be located on the sides, front or back of the device.
  • FIG. 5 is a side view of an exemplary embodiment of the housing 120.
  • the control module 130 of the housing 120 is knob-shaped to allow easy gripping and manipulation by the gloved hand of a practitioner.
  • C0 2 gas enters the device from the C0 2 source by way of a tube 140 connected to the device.
  • the flat contact surface 110 of the device can be in the form of a roller element.
  • a plurality of needles are mounted on the roller element, wherein the roller is rotatably mounted on an axle or other suitable configuration of the device that will allow the roller to be rotatable as contemplated herein.
  • the axle or other suitable configuration can include one or a plurality of passageways to allow the C0 2 to be in fluid communication with the needles.
  • the plurality of needles suitably allow infusion of C0 2 to a patient in need of such treatment when one or more of the plurality of needles is below the surface of a patient's skin.
  • the number of needle rows that make up the contact surface of the roller element of the present device can vary according to the desired treatment regimen.
  • the roller device comprises a plurality of needles permanently attached to the roller device.
  • the roller element can be disengaged from the device via removable connection.
  • the roller element is disposable, being replaceable for each new patient. In other embodiments, the roller unit is sterilizable.
  • the plurality of needles in the roller element are removable and replaceable.
  • the needles are integrated into a disposable roller cover.
  • the roller cover can be securely attached to the roller, whereby the roller element is suitably perforated to allow C0 2 to pass into the needles integrated into the roller cover.
  • C0 2 will pass into the skin of the patient when the roller device is placed on a patient's skin.
  • This needled roller cover can enhance safety of the roller device of the present application.
  • the roller element can be sterilizable to further enhance safety.
  • the skin treatment device 100 is attached to a pressured treatment fluid source, such as a C0 2 tank or cartridge.
  • a pressured treatment fluid source such as a C0 2 tank or cartridge.
  • the skin treatment device and method of the present application does not comprise a piston or other form of delivery enhancement mechanism.
  • the present application introduces the treatment fluid into or beneath the skin surface substantially by the pressure from the pressured treatment fluid source.
  • FIG. 6 show one configuration of a treatment device 100 having a handle portion 202. At a first end of handle portion 202, a hose element 204 is attached to a source of C0 2 gas (not shown). As an optional feature, a regulator 206 can be included on treatment device 100. A switch 208 can facilitate operation. In use, end piece 210 is attachable to microneedle/base element 212. Microneedle 214 and base material 216 are also shown. [0057] Referring to FIG. 7, microneedle/base element 212 is shown in contact with patient's skin 300 and in penetration to an interior skin portion 302. The microneedles 214 have a hollow end 218 that will fill with C02 gas (not shown) in a penetration area 304.
  • FIG. 8 an exemplary configuration of a microneedle/base element 220 is shown.
  • An area of base material 216 is provided with a plurality of microneedles 214.
  • FIG. 9 another exemplary configuration of a microneedle/base element 222 is shown.
  • An area of base material 216 is provided with a plurality of microneedles 214.
  • the shape of the base element is not limited to the exemplified shapes. The present application envisions any shape of base element that is suitable for carrying out the methods disclosed in the present application. The shape may be determined by the contours of the area of the body to be treated or by the need to avoid a particular bodily feature.
  • the device of the present application comprises a plurality of interchangeable head units with rings of microneedles of varying diameters.
  • the device comprises a first interchangeable head with a ring, or rings, of microneedles with a large diameter so that when the ring(s) is/are centered on the skin disorder being treated, the ring(s) is/are at the greatest distance from the skin disorder.
  • the device further comprises one or more interchangeable heads having ring(s) of smaller diameter than the ring(s) on said first interchangeable head, thereby bringing the ring(s) closer to the skin disorder being treated.
  • a skin treatment system comprising a self-contained treatment fluid source, a pressure regulator for regulating the pressure of the treatment fluid, an filter for filtering out contaminants such as bacteria, viruses and other gaseous impurities in the treatment fluid, a heating system for raising the temperature of the treatment fluid, a flow regulator for controlling the flow of the treatment fluid, and a skin treatment device for delivering the treatment fluid into or beneath the skin of a patient.
  • the treatment fluid is C0 2 gas.
  • the C0 2 gas is medical grade C0 2 gas, thereby reducing or eliminating the need for a filter.
  • the contact surface or the roller of the skin treatment device is directed over the skin of a patient so that at least some of the plurality of needles projecting from the contact surface penetrate the skin of the patient.
  • the treatment fluid such as C0 2
  • the treatment fluid will suitably travel into and below the skin of the patient in a desired amount over a desired period time to provide the desired treatment.
  • the treatment can be conveyed at various distances below the patient's skin surface.
  • the frequency of the movement of the roller over the skin determines the number of puncture channels, which can be controlled specifically and thus also the degree to which the treatment fluid can penetrate the patient's skin.
  • a treatment device of the present application the
  • microneedle/base element and one or more companion products are packaged together and marketed as a kit.
  • the examples of the items in the kit may include, but are not limited to, the device including a pre-determined number of disposable or replaceable microneedle/base element configurations, a reusable treatment device for application of carboxytherapy and one or more additional treatments of electrical stimulation, galvanic action or heat therapy, a topical treatment composition in a suitable container/dispenser (such as a tube, a bottle, a pump, ajar, a dropper, a or unit-dose dispenser) to be used before, during, or after the device application.
  • the kit may also contain a cleansing product to be used to sanitize/sterilize the skin prior to the device application.
  • the kit may also include a film forming composition or bandage to be used after treatment to protect the treated skin site and to enhance the therapeutic efficacies for the treated skin.
  • Treatment in accordance with the methods of the present application may be localized, such that the target site of a pimple or other blemish, a wrinkle, a razor
  • the treatment can be used on larger areas such as the scalp (to enhance hair growth) or the thighs or other areas (for example, to treat cellulite).
  • a patient is treated by: (a) affixing a treatment device comprising a plurality of microneedles securely attached to a surface material; (b) applying pressure to the device such that one or more of the plurality of microneedles penetrates the skin of the patient; (c) applying a carboxytherapy treatment; and optionally one or more of a galvanic treatment, electrical stimulation or heat treatment; and (d) removing the microneedles from the patient's skin.
  • a medical professional places a treatment device so that the microneedle/base element is in contact or substantially in contact with a location of the skin of a patient.
  • the treatment device is activated by the user, such as by using a plunger, piston or the like, so that at least some of the plurality of microneedles projecting from the base material penetrates the skin of the patient.
  • C0 2 is applied from a source and, since the needles are in fluid communication with the source of C0 2 , the gas will suitably travel into and below the skin of the patient thereby providing a carboxytherapy treatment.
  • the plurality of needles suitably allow application of carboxytherapy to a patient in need of such treatment when one or more of the plurality of microneedles is below the surface of a patient's skin.
  • flow rates for C0 2 gas can be from about 5 to about 300 ml/min.
  • the C0 2 flow rates are from 50 to about 200 ml/minute, or from about 80 to about 120 ml/min.
  • C0 2 flow rates can be from about 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 100, 1 10, 120, 150, 170 or 200 ml/min, where any value can form an upper or lower endpoint, as appropriate.
  • the flow rates for C0 2 gas are in the range of 5-10 ml/min, 5-20 ml/min, 5-40 ml/min, 5-80 ml/min, 5-100 ml/min, 5-120 ml/min, 5-150 ml/min, 5-200 ml/min, 5-250 ml/min, 10-20 ml/min, 10-40 ml/min, 10-80 ml/min, 10-100 ml/min, 10-120 ml/min, 10-150 ml/min, 10-200 ml/min, 10-250 ml/min, 10-300 ml/min, 15-20 ml/min, 15-40 ml/min, 15-80 ml/min, 15-100 ml/min, 15-120 ml/min, 15-150 ml/min, 15-200 ml/min, 15-250 ml/min, 15- 300 ml/min, 20-40 ml/min, 20-80 ml/min
  • the C0 2 gas is supplied at a variable flow rate within a single treatment or among multiple sessions of treatments.
  • a single treatment session comprises a period of high flow rate (e.g., 100-200 ml/min), a period of medium flow rate (e.g., 40-99 ml/min), and a period of low flow rate (e.g., 10-39 ml/min).
  • a complete treatment regimen comprises one or more sessions at a high flow rate (e.g., 100-200 ml/min), one or more sessions at a medium flow rate (e.g., 40-99 ml/min), and one or more sessions at a low flow rate (e.g., 10-39 ml/min).
  • Time for such treatments can vary from about 30 seconds to about 180 seconds or from about 45 seconds to about 90 seconds.
  • Time for treatment is from about 30, 45, 60, 75, 90, 105, 120, 135, 150, 165 or 180 seconds, where any value can form an upper or lower endpoint, as appropriate.
  • flow rates for the C0 2 gas can be from about 40 to about 360 ml/min or from about 90 to about 240 ml/min.
  • C0 2 flow rates for subcutaneous carboxytherapy treatment can be from about 5, 10, 15, 20, 30, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 or 360 ml/min, where any value can form an upper or lower endpoint, as appropriate.
  • the flow rates for C0 2 gas are in the range of 5-10 ml/min, 5-20 ml/min, 5-40 ml/min, 5-80 ml/min, 5-100 ml/min, 5-120 ml/min, 5-150 ml/min, 5-200 ml/min, 5-250 ml/min, 5-300 ml/min, 5-360 ml/min, 10-20 ml/min, 10-40 ml/min, 10-80 ml/min, 10-100 ml/min, 10-120 ml/min, 10-150 ml/min, 10-200 ml/min, 10-250 ml/min, 10-300 ml/min, 10- 360 ml/min, 15-20 ml/min, 15-40 ml/min, 15-80 ml/min, 15-100 ml/min, 15-120 ml/min, 15- 150 ml/min, 15-200 ml/min, 15-250 ml/min, 15-250 m
  • a single treatment session comprises a period of high flow rate (e.g., 200-360 ml/min), a period of medium flow rate (e.g., 50-199 ml/min), and a period of low flow rate (e.g., 5-49 ml/min).
  • a complete treatment regimen comprises one or more sessions at a high flow rate (e.g., 200-360 ml/min), one or more sessions at a medium flow rate (e.g., 50-199 ml/min), and one or more sessions at a low flow rate (e.g., 5-49 ml/min).
  • Treatment times for subcutaneous fact treatment can be from about 1 to about 8 minutes, or from about 2 to about 6 minutes.
  • the treatment time for subcutaneous injection of C0 2 can be from about 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7.0, 7.5, 8, 10, 15, 20 or 30 minutes, where any value can comprise an upper or lower endpoint as appropriate.
  • the microneedle/base element and the treatment device can be configured to allow electric current travel into the skin of the patient during the treatment of a patient.
  • the electricity supplied to the disrupted area may also accelerate healing and other benefits that can magnify the therapeutic benefits of carboxytherapy alone.
  • the microneedles can comprise a conductive material so as to allow application of heat (and/or to heat the C0 2 ) during a treatment.
  • the microneedles prior to activation of electrical stimulation in the device, are inserted into the skin of the patient to disrupt the skin at the desired location(s) thereby, increasing the electric current passage at the selected skin locations to enhance the desirable effect of electric stimulation.
  • the electrical aspect of the treatment device of the present invention can be powered by powered by a power source, such as battery, piezoelectric, electric-mechanical (e.g., a coil magnet), or by a galvanic couple, the disclosure of which is incorporated in its entirety by this reference, so that processes of stratum corneum disruption and electric stimulation are conducted with the same device without the need of changing devices during the treatment.
  • a power source such as battery, piezoelectric, electric-mechanical (e.g., a coil magnet), or by a galvanic couple, the disclosure of which is incorporated in its entirety by this reference, so that processes of stratum corneum disruption and electric stimulation are conducted with the same device without the need of changing devices during the treatment.
  • the skin treatment device of the present invention can comprise suitable materials to provide galvanic action.
  • the microneedles and/or the base material can be made from two dissimilar metals in contact with each other so that they form a galvanic couple, and are therefore capable of generating a galvanic current when the microneedles/base material contacts an electrolyte-containing medium.
  • the base material can comprise a thin zinc sheet, fabricated with the manufacture methods disclosed in U.S. Pat. Nos.
  • both metals of the galvanic couple (i.e., zinc and silver-silver chloride) on the microneedle/base element member can be in contact with an electrolyte medium (e.g., a topical composition, or a body fluid such as sweat) and/or the skin to act as a galvanic cell (e.g., of approximately 1 volt) and to generate an electric current, going out from the zinc positive electrode, passing through the electrolyte medium and/or the skin, and returning into the silver-silver chloride negative electrode.
  • an electrolyte medium e.g., a topical composition, or a body fluid such as sweat
  • a galvanic cell e.g., of approximately 1 volt
  • the two metals forming the galvanic couple may be made to contact the third metal (e.g., titanium, or stainless steel) from which can be configured on or within one or more of the microneedle material or base element material.
  • the third metal e.g., titanium, or stainless steel
  • a zinc layer may be coated onto the selective areas of a titanium or stainless steel microneedles member by electric plating, electroless plating, or using a conductive ink including a zinc powder and a polymer binder.
  • a silver-silver chloride layer may be coated to other areas of a titanium or stainless steel microneedles.
  • the conductive metallic microneedle serves as a lead to connect the galvanic elements zinc and silver-silver chloride.
  • a galvanic current is generated when both galvanic elements coming into contact with the electrolyte medium and/or the skin during the device application.
  • the skin of the patient can first be treated with a relatively high concentration of cosmetically acceptable organic solvent, (e.g., glycerin, propylene glycol, or polyethylene glycol), or a non-conductive solute (e.g., low molecular weight sugars, dextrans, or urea).
  • a relatively high concentration of cosmetically acceptable organic solvent e.g., glycerin, propylene glycol, or polyethylene glycol
  • a non-conductive solute e.g., low molecular weight sugars, dextrans, or urea
  • Another aspect of the present application relates to a method of applying carboxytherapy to a subject in need of such treatment.
  • the method comprises the steps of: contacting a target body surface of a subject with a treatment device comprising: a plurality of hollow needles attached to a contact surface of a housing; and a C0 2 source in fluid 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 outermost layer of cell in the target body surface; skin of the patient; applying a therapeutic amount of C0 2 to the subject through the plurality of hollow needles; and removing the plurality of hollow needles from the target body surface.
  • the subject is a mammal.
  • the mammal is a human.
  • the mammal is a domestic animal, such as a dog, a cat, a monkey, a rat, a mouse, a rabbit, a guinea pig and the like.
  • the mammal is a farm animal, such as a cow, a horse, a pig, a sheep, a goat, and the like.
  • the mammal is a zoo animal.
  • the method further comprises the step of subjecting the target body surface to one or more additional treatments selected from the group consisting of galvanic treatments, electrical stimulations, heat treatments and light treatments.
  • the one or more additional treatments are provided concurrently with the carboxytherapy using the same treatment device.
  • the one or more additional treatments are provided prior to or after the carboxytherapy.
  • the method further comprises the step of applying to the target body surface an effective amount of a treatment composition formulized for topical administration.
  • the plurality of hollow needles are microneedles having a diameter of about 0.1 mm to about 0.5 mm and a length of about 0.4 mm to about 2.1 mm.
  • the target body surface is suffering from a skin condition selected from the group consisting of acne, psoriasis, skin infections, blemishes, hyperpigmentation, hypopigmentation, alopecia, excessive hair growth, unwanted hair growth, rough skin, dry skin, lax skin, wrinkles, hypervasculatated skin, sebum production disorders, excessive pore appearance, excessive perspiration, hyperhidrosis, tattoo appearance, rashes, scar appearance, pain, itch, burn, inflammation, warts, corns, calluses, edema, ivy/oak poisoning, and bites from insects, spiders, snake, and other animals.
  • the target body surface is scalp suffering from hair loss.
  • the target body surface is suffering from alopecia areata. In another embodiment, the target body surface is suffering from diabetic ulcer. In another embodiment, the target body surface is suffering from straie. In yet another embodiment, the target body surface is a scarred body surface.
  • Another aspect of the present application relates to a method for treating hair loss in a target area, such as scalp.
  • the method comprises the step of introducing an effective amount of C0 2 into the subcutaneous tissue of the target area for a sufficient period of time.
  • the effective amount of carbon dioxide is introduced into the target area with a plurality of hollow needles that puncture epidermis of the target area and release carbon dioxide at a desired rate within the subcutaneous tissue.
  • the C0 2 is introduced into the target area using the skin treatment device and/or the of the skin treatment system of the present application.
  • the plurality of needles in the skin treatment device are selected to have a size and spaced relationship suitable for hair loss treatment.
  • the C0 2 is introduced at a flow rate of 50-200 ml/min and for a period of 10-60 minutes.
  • the introducing step is repeated 4-20 times with an interval of about 24-72 hours between any two repeats.
  • the method further includes the step of applying a local anesthetic to the target area prior to the introducing step.
  • local anesthetic include, but are not limited to, of procaine, amethocaine, cocaine, lidocaine, prilocaine, bupivacaine, levobupivacaine, ropivacaine, mepivacaine and dibucaine, etidocaine, chloroprocaine, sarapin, benzocaine, tetracaine, pramoxine, oxyprocaine, dyclonine, propoxycaine, chloroxylenol, cinchocaine, dexivacaine, diamocaine, hexylcaine, pyrrocaine, risocaine and rodocaine.
  • the method further include the step of applying a composition comprising a hair growth promoting agent to the target area, wherein the composition is formulated for topical application.
  • hair growth promoting agents include, but are not limited to, hair growth factors, minoxidil, finasteride and kopexil, including analogues and derivatives therefrom; cyclosporin 7-thioamide, donepezil hydrochloride, antiandrogenic agents, bimatoprost, Sophora flavescens extract, Serenoa serrulata fruit extract, Serenoa repens extract, licorice extract.
  • Another aspect of the present application relates to a method for treating a skin condition in a target area.
  • the method comprises the step of introducing an effective amount of C0 2 into the subcutaneous tissue of the target area for a sufficient period of time.
  • the effective amount of carbon dioxide is introduced into the target area with a plurality of hollow needles that puncture epidermis of the target area and release carbon dioxide at a desired rate within the subcutaneous tissue.
  • the subcutaneous layer comprises adipose tissue
  • the C0 2 is introduced into the target area using the skin treatment device and/or the of the skin treatment system of the present application.
  • the plurality of needles in the skin treatment device are selected to have a size and spaced relationship suitable for the treatment.
  • the C0 2 is introduced at a flow rate of 40-360 ml/min and for a period of 2-120 minutes.
  • the introducing step is repeated 1-40 times with an interval of about 6-120 hours between any two repeats.
  • the method further includes the step of applying a local anesthetic to the target area prior to the introducing step.
  • local anesthetic include, but are not limited to, of procaine, amethocaine, cocaine, lidocaine, prilocaine, bupivacaine, levobupivacaine, ropivacaine, mepivacaine and dibucaine.
  • Examples of skin conditions include, but not limited to, , eczema, seborrhea, vitiligo, lentigo, scleroderma, sunburn, sun damaged skin, estrogen imbalance,
  • pseudofolliculites senile comedones, nevus comidonicas, and trichostatis spinulosa
  • benign epithelial tumors e.g., flat warts, trichoepithelioma, and molluscum contagiosum
  • perforated dematoses e.g., elastosis perforans seripiginosa and Kyrles disease
  • disorders of keratinization e.g., Dariers disease, keratoderma, hyperkeratosis plantaris, pityriasis rubra pilaris, lichen planus acanthosis nigricans, and psoriasis
  • pityriasis e.g., pitiyriasis rosea, pityriasis rosacea and pityriasis rubra
  • keratoses impetigo, erysipelas, eryth
  • the method further include the step of applying a composition comprising a therapeutic agent to the target area, wherein the composition is formulated for topical application.
  • the therapeutic agents include, but are not limited to, , antimicrobial agents, analgesic and/or non-steroidal anti-inflammatory (NSAID) agents, steroidal/corticosteroidal agents, wound repair agents, anti-cancer agents and skin benefit agents.
  • NSAID non-steroidal anti-inflammatory
  • antimicrobial agents include, but are not limited to, anti-bacterial agents (e.g., clindamycin and erythromycin, zithromycin, minocycline, tetracycline, kanamycin, metronidazole, neomycin, bacitracin, polymixin, mafenide acetate, silver sulfadiazine, gentamicin sulfate; anti-fungal agents (terbinafine, itraconazole, micronazole nitrate, thiapendazole, tolnaftate, clotrimazole and griseofulvin caprylyl glycol, triclosan, phenoxyethanol, nystatin or clortrimazole); anti-viral agents (e.g., acyclovir, brivudine, cidofovir, desciclovir, didanosine, famciclovir, 5-fluorouracil, 2-deoxy- and 5-deoxy-5
  • Another aspect of the present application relates to a method for promoting wound healing in a target area, such as scalp.
  • the method comprises the step of introducing an effective amount of C(3 ⁇ 4 into the subcutaneous tissue of the target area for a sufficient period of time.
  • the effective amount of carbon dioxide is introduced into the target area with a plurality of hollow needles that puncture epidermis of the target area and release carbon dioxide at a desired rate within the subcutaneous tissue.
  • the CO2 is introduced into the target area using the skin treatment device and/or the of the skin treatment system of the present application.
  • the plurality of needles in the skin treatment device are selected to have a size and spaced relationship suitable for the treatment.
  • the C0 2 is introduced at a flow rate of 5-300 ml/min and for a period of 10-60 minutes.
  • the introducing step is repeated 5-20 times with an interval of about 24-120 hours between any two repeats, or sessions.
  • a session of the method of treating a skin disorder comprises several application steps.
  • a first application step comprises the insertion of needles in a ring a great distance from the skin disorder being treated, for example a distance of between two to four inches.
  • the flow rate of the device is relatively high, for example between 120 and 200 ml/min.
  • Said first application step is followed by at least one intermediate step, wherein the ring of insertion is brought closer to the skin disorder being treated than the first application step or the preceding intermediate step.
  • the flow rate is reduced from the application step immediately prior, for example to a flow rate of between 40 and 120 ml/min.
  • the session comprises a final application step to the skin immediately around the periphery of (such as for an open wound) or within (such as for scars or stria) the skin disorder being treated.
  • Said final application step is carried out at a relatively low flow rate, for example at a flow rate of between 5 and 20 ml/min.
  • the method further includes the step of applying a local anesthetic to the target area prior to the introducing step.
  • local anesthetic include, but are not limited to, of procaine, amethocaine, cocaine, lidocaine, prilocaine, bupivacaine, levobupivacaine, ropivacaine, mepivacaine and dibucaine.
  • the method further include the step of applying a composition comprising wound healing promoting agent to the target area, wherein the composition is formulated for topical application.
  • wound healing promoting agents include, but are not limited to, TGF-related growth factors (TGF- ⁇ , TGF-P2, TGF- 133), PDGF-related growth factors (PDGF-M, PDGF-BB, VEGF), FGF-related growth factors (a-FGF, b-FGF, KGF), IGF-related growth factors (IGF-1, IGF-II, insulin), EGF- related growth factors (EGF, HB-EGF, TGFa, amphiregulin, betacellulin), HGF/SF, VEGF, CTGF, TNFa, IL-1 , IL-2, IL-6, IL-8, ⁇ -interferon, IL-4, IL-10, matrix metalloproteinases (MMPs; MMP-1, -2, -3, -7, -8, -9, TGF-related growth factors (M
  • compositions formulated for topical administration may be in the form of a cream, lotion, gel, serum, tonic, emulsion, paste, or spray for topical administration.
  • cream refers to a spreadable composition, typically formulated for application to the skin. Creams typically contain an oil and/or fatty acid based-matrix.
  • the effective amount of C0 2 depends on the method of treatment. In some embodiments, the effective amount of the C0 2 is defined by the rate of the C0 2 given in the target area and the duration of treatment is a single session . While the effective amount of carbon dioxide may vary from patient to patient, in some embodiments, the C0 2 is introduced into the target area at a flow rate of about 0.1-20 ml/cm 2 /min, about 0.1 -1 ml/cm 2 /min, about 0.1 -2 ml/cm 2 /min, about 0.1-5 ml/cm 2 /min, about 0.1 -10 ml/cm 2 /min, about 0.1 -15 ml/cm 2 /min, about 0.5-2 ml/cm 2 /min, about 0.5-5 ml/cm 2 /min, about 0.5-10 ml/cm 2 /min, about 0.5-15 ml/cm 2 /min, about 0.5-20 ml/c
  • the treatment comprises 2-40, 2-30, 2-20, 2-10, 2-5, 4-40, 4-30, 4-20, 4-10, 6-40, 6-30, 6-20, 6-10, 8-40, 8-30, 8-20, 10-40, 10-30, 10-20, 15-40, 15-30, 15- 20, 20-40 or 20-30 sessions with an interval of about 12-72, 12-48, 12-24 hours between each two sessions.
  • the multi-needle approach decreasse the time needed to provide a beneficial amount of C0 2 to a patient in need of such treatment without also reducing the efficacy of such a treatment.
  • beneficial C0 2 treatment can be applied to large surfaces in a short period time.
  • the method of treatment using the device of the present application does not involve the application of any active ingredient other than C0 2 .
  • the method of using the device consists essentially of the application of C0 2 below the skin of a patient needing treatment thereof.
  • a male patient presented with generalized thinning of the hair across the entire crown of his scalp.
  • the patient was subjected to once-monthly clinical carboxytherapy treatment. At three months, the patient exhibited substantial in-filling of the thinned region.
  • the treatment protocol was changed to twice-monthly administration of carboxytherapy and at five months the patient showed significant coverage of the crow region with normal- textured hair.
  • C0 2 transdermal treatment Ten insulin-dependent diabetic patients with chronic lower extremity wounds were referred for C0 2 transdermal treatment.
  • the control group consisted of five of the patients, three who were claustrophobic and two who refused C0 2 insufflation treatments because of logistic reasons.
  • An exemplary protocol for a C0 2 insufflation treatment of an ulcerated wound comprises several steps of C0 2 application.
  • a first application step comprises inserting microneedles in a ring of large radius around the wound, for example about two inches from the edges of the wound.
  • C0 2 gas is insufflated at a high flow rate, for example between 120 and 200 ml/min, more particularly about 150 ml/min.
  • This is followed by a second application in a smaller ring, about one inch from the edges of the wound.
  • C0 2 gas is insufflated at a lower flow rate, for example between 50 and 100 ml/min, more particularly about 80 ml/min.
  • C0 2 gas is insufflated at a still lower flow rate, for example between 30 and 50 ml/min, more particularly about 40 ml/min.
  • a last application step is made in the skin immediately around the periphery of the wound using a single microneedle applicator using a very low flow rate of between about 5 and 25 ml/min, more particularly about 15-20 ml/min.
  • the patient Prior to carboxytherapy, the patient was treated with antibiotics and extensive necrotic exeresis with no revascularization procedure, after six applications of carboxytherapy treatment, the wound has begun to close and new skin is forming over the wound after 12 applications of carboxytherapy. Following 16 applications od carboxytherapy treatment, there was a substantial reduction in size of the wound, with the remainder being covered over by a scab. The wound was fully covered over by new skin growth after 20 carboxytherapy application.
  • Striae commonly known as stretch marks, can appear when there is rapid stretching of the skin. They are often associated with the abdominal enlargement of pregnancy. They also can be found in children who have become rapidly obese or may occur during the rapid growth of puberty in males and females. Striae are most commonly located on the breasts, hips, thighs, buttocks, abdomen, and flank.
  • a female patient presented with straie on the buttocks and was treated with a course of once/monthly carboxytherapy treatments at an administration rate of 80 ml/min. Following six carboxytherapy treatments, the appearance of the straie was significantly diminished.
  • Scars are a natural result of some kind of injury to the skin. They can occur because of surgery, accidental injury, acne or infection. As skin heals, the area can become thickened, raised and discolored, resulting in a permanent scar. Some scars fade with time, but most remain visible. Even those that fade may take years to do so. In some instances, scar tissue may cause physical discomfort. In others, visible scars may cause embarrassment or emotional discomfort for a patient, for example, such as scars left after some types of reconstructive surgery.
  • a female patient presented with raised, darkened, keloid scars on the breasts and abdomen following reconstructive surgery.
  • the patient was treated with a course of once/monthly carboxytherapy treatment at a flow rate of 80 ml/hr. Following six treatments, the scars were no longer raised and had lightened to more closely approximate the patient's natural skin tone.

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Abstract

La présente invention concerne un procédé et un appareil d'application de carboxythérapie à un sujet. Le procédé comprend les étapes de : mise en contact d'une surface corporelle cible du sujet avec un dispositif de traitement comprenant une pluralité d'aiguilles creuses fixées à une surface de contact d'un boîtier et une source de CO2 en communication fluidique avec au moins une de la pluralité d'aiguilles creuses ; application d'une pression sur le boîtier de sorte qu'une ou plusieurs de la pluralité d'aiguilles creuses pénètrent un épiderme ou une couche externe de cellules dans la surface corporelle cible ; application d'une quantité thérapeutique de CO2 au sujet par l'intermédiaire de ladite pluralité d'aiguilles creuses ; et retrait de la pluralité d'aiguilles creuses de ladite surface corporelle cible. La présente invention concerne en outre un procédé d'application de carboxythérapie pour améliorer des affections cutanées.
EP13877866.7A 2013-03-15 2013-03-15 Appareil et procédé pour le rajeunissement tissulaire Withdrawn EP2968885A4 (fr)

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EP3808406A1 (fr) 2015-09-15 2021-04-21 i-LUMEN Scientific, Inc. Appareil pour thérapie de stimulation oculaire par microcourants
ES2961009T3 (es) 2018-12-20 2024-03-07 I Lumen Scient Inc Sistema para terapia de estimulación por microcorriente
US11395878B2 (en) 2019-03-15 2022-07-26 Daphne Lodge Injection device and method of making and using the same
US20220125831A1 (en) * 2019-07-11 2022-04-28 Renee Tornatore Regenerative co2 treatment system and method
KR102214553B1 (ko) * 2019-08-06 2021-02-09 아주대학교산학협력단 약액 주입을 위한 미세바늘 스탬프 기기
KR102294546B1 (ko) * 2019-09-26 2021-08-26 제주대학교 산학협력단 플라즈마 기체를 이용한 피부 미용 및 치료 장치, 플라즈마 기체를 이용한 피부 미용 및 치료 방법
FR3124397B1 (fr) 2021-06-24 2023-08-04 Oreal Dispositif destiné à la thérapie par injection de fluide
WO2022231011A1 (fr) 2021-04-28 2022-11-03 L'oreal Dispositif pour une thérapie par injection de fluide
WO2022244855A1 (fr) 2021-05-20 2022-11-24 L'oreal Dispositif pour la thérapie cosmétique
FR3125428B1 (fr) 2021-07-20 2024-02-02 Oreal Dispositif pour thérapie cosmétique
WO2023102082A2 (fr) * 2021-12-05 2023-06-08 Tianxin Wang Méthodes et dispositifs pour traiter des démangeaisons
FR3147506A1 (fr) 2023-04-07 2024-10-11 L'oreal Dispositif de carboxytherapie avec micro-aiguille creuse
FR3147505A1 (fr) 2023-04-07 2024-10-11 L'oreal Dispositif de carboxytherapie avec micro-aiguille creuse

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6607513B1 (en) * 2000-06-08 2003-08-19 Becton, Dickinson And Company Device for withdrawing or administering a substance and method of manufacturing a device
US6589202B1 (en) * 2000-06-29 2003-07-08 Becton Dickinson And Company Method and apparatus for transdermally sampling or administering a substance to a patient
US7967763B2 (en) * 2005-09-07 2011-06-28 Cabochon Aesthetics, Inc. Method for treating subcutaneous tissues
ITRM20050478A1 (it) * 2005-09-23 2007-03-24 Promoitalia Cosmetic Line S R L Apparato per l'applicazione contemporanea della carbossiterapia e della mesoterapia.
ES2360867T3 (es) * 2005-12-21 2011-06-09 Carbossiterapia Italiana S.R.L. Aparato y método para la administración subcutánea de gas para fines terapéuticos.
US9808611B2 (en) * 2006-05-19 2017-11-07 Oxyband Technologies, Inc. Systems and methods for enhancing gas and vapor transfer for tissue treatment devices
KR100819468B1 (ko) * 2007-05-31 2008-04-08 (주)엠큐어 멀티 인젝션이 가능한 멀티홀 시술 장치

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2014142970A1 *

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WO2014142970A1 (fr) 2014-09-18
KR20160045626A (ko) 2016-04-27
JP2016514004A (ja) 2016-05-19
EP2968885A4 (fr) 2017-03-01
WO2014142970A9 (fr) 2016-08-25

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