Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
  • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
  • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
  • A61B18/203—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser applying laser energy to the outside of the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
  • A61K31/19—Carboxylic acids, e.g. valproic acid
  • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
  • A61K31/203—Retinoic acids ; Salts thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/67—Vitamins
  • A61K8/671—Vitamin A; Derivatives thereof, e.g. ester of vitamin A acid, ester of retinol, retinol, retinal
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin
  • A61Q19/08—Anti-ageing preparations
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00743—Type of operation; Specification of treatment sites
  • A61B2017/00747—Dermatology
  • A61B2017/00761—Removing layer of skin tissue, e.g. wrinkles, scars or cancerous tissue
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00743—Type of operation; Specification of treatment sites
  • A61B2017/00747—Dermatology
  • A61B2017/00765—Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
  • A61B2018/00452—Skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
  • A61B2018/00452—Skin
  • A61B2018/0047—Upper parts of the skin, e.g. skin peeling or treatment of wrinkles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
  • A61K2800/81—Preparation or application process involves irradiation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N5/00—Radiation therapy
  • A61N5/06—Radiation therapy using light
  • A61N5/0613—Apparatus adapted for a specific treatment
  • A61N5/062—Photodynamic therapy, i.e. excitation of an agent

Definitions

• the present invention relates generally to laser treatment of the skin and, more particularly, to a laser treatment inducing a chronic wound in the high dermis, leaving the epidermis intact, with topical pretreatment and post-treatment of the skin with retinoic acid.
• Laser light treatment of the skin is used to rejuvenate the skin, remove pigments and hair, and treat infection.
• the use of lasers is principally based upon two types of mechanisms: a thermal effect where the laser light energy is converted into heat energy, or a mechanical effect where the laser light energy is converted into Shockwaves in the skin.
• Retinoic acid (Retin-A, tretinoin) has also been used as a topical dermal treatment to improve the appearance and texture of the skin. Retinoic acid thins the stratum corneum, increases the thickness of the epidermis, and increases the production of collagen in the dermis. However, retinoic acid causes skin redness and sensitivity to the sun. Repeated use can cause a loss of pigment, painful irritation, dryness, swelling of the skin, and contact dermatitis.
• Tankovich et al. (U.S. Patent No. 6,036,684) developed a laser method of photomechanical activation in the skin using a Q switched Nd:YAG laser with a wavelength of 1064nm and an exposure of 2.5 J/cm 2 . Exposure of the skin to this type of laser treatment by itself has no effect on the skin because the skin has no inherent target at the 1064nm wavelength. However, when an activating solution of graphite or carbon particles suspended in baby oil is applied to the skin, these particles become the target of this 1064nm wavelength, exploding when exposed to the laser light.
• the particles Prior to application of the laser, the particles are forced into the skin, below the surface of the stratum corneum using ultrasound. Thereafter, the explosion of the carbon particles by the laser light produces a localized mechanical injury in the hair follicles and pores of the skin. There is no significant injury to the skin tissue because the laser energy which is not absorbed in the carbon is harmlessly dissipated in the skin. The low fluence of 2.5 J/cm 2 leaves the epidermis intact and the typical adverse effects of laser treatment do not occur.
• the present invention provides a process and method for producing skin rejuvenation and therapy by pretreating the skin with retinoic acid, producing a chronic thermal injury wound in the high dermis using photomechanical laser therapy, maintaining skin rejuvenation and therapy chronically by repeating the thermal injury in the high dermis at least once per year, and by topically applying retinoic acid bi-weekly.
• a Q-switched Nd:YAG laser with a wave length of 1064nm is used at 2.5 J/cm 2 to vaporize a topical activating solution of carbon particles suspended in baby oil.
• a single treatment of the face can be completed in 4 minutes without anesthesia, with no need for a period of recovery, and at a relatively low cost.
• An advantage of the present invention is the production of a chronic wound in the high dermis with no damage to the epidermis.
• Another advantage of the present invention is the enhancement of laser-induced collagen deposition in the high dermis with retinoic acid.
• Another advantage of the present invention is the chronic life-time rejuvenation and therapy of the skin.
• Another advantage of the present invention is the removal and prevention of acne by suppression of sebaceous glands and reduction of skin pore size.
• Another advantage of the present invention is laser therapy at a low energy level.
• Another advantage of the present invention is the use of retinoic acid without side effects.
• Another advantage of the present invention is therapeutic removal of infections of the skin.
• Another advantage of the present invention is the chronic rejuvenation and therapy of the skin at a relatively low cost.
• Another advantage of the present invention is that a single treatment of the skin of the face can be completed within four minutes.
• Fig. 1 describes the method of the present invention.
• Fig. 2 illustrates a cross sectional view of the skin and the role of heat and oil in the method of the present invention.
• Fig. 3 describes the process of the present invention.
• Fig. 4 shows the effects of the laser method of the present invention on the restoration of the skin of a patient suffering from acne vulgaris.
• Wound healing in the skin occurs over a year's time after an initial wounding, regardless of the means by which the wounding is induced.
• the wound In the first five days the wound is comprised of inflammatory cells and new blood vessels. Then an immature form of collagen is laid down parallel to the skin surface. For six months the body shifts this collagen around, trying to identify the strongest repair. Around six months after the initial wounding, this immature collagen is replaced with mature collagen protein oriented perpendicular to the skin surface. Three months into this process, or months ten, eleven, and twelve from the initial wounding, these protein strands cross-link. This effect is visible on the skin's surface as an apparent shrinkage of the size of the scar to one third its original size.
• the wound becomes quiescent. However, any additional insult to the wound site during the first six months of repair causes a signal for a stronger permanent repair. Any additional insult to the wound site during the second six months results in additional mature collagen in the wound. As long as some injury is repeated before twelve months has elapsed, the site becomes a chronic wound producing more collagen, undergoing more cross-linking, and more total surface area shrinkage.
• the method and process of the present invention described herein outlines a series of treatments using the Tankovich laser and activating solution to maximize the initial wounding signal during the first six months of application.
• the Tankovich processes disclosed in U.S. Patent No. 5,423,803 and U.S. Patent No. 6,036,684 are incorporated herein by reference.
• the activating solution does not need to be forced into the spaces of the skin with ultrasound as required by the Tankovich process.
• a series of booster laser treatments is given until the desired skin resurfacing end point is reached. At a minimum, one booster laser treatment is given before twelve months has elapsed to keep the wound active.
• Fig. 1, Step 10 is a topical pretreatment of the skin with a collagen inducing agent and an angiogenesis inducing agent, preferably, retinoic acid, and in particular its nongeneric form, such as Retin-A (tretinoin).
• Retinoic acid returns the architecture of the skin back to its more youthful form.
• a collagen inducing agent and an angiogenesis inducing agent preferably, retinoic acid
• Retinoic acid returns the architecture of the skin back to its more youthful form.
• tin-A tretinoin
• the basal cells which originate at the dermal- epidermal junction 21 create the layers of the epidermis every three weeks. With aging, this slows to four to six weeks.
• Topical retinoic acid on the skin returns the process to every three weeks.
• the top most layer of epidermal cells, the stratum corneum is comprised of dead cells held together by a cell glue. With age, this layer thickens making the skin less fresh-appearing and making the pores larger.
• Topical retinoic acid directly attacks the cell glue, thinning the stratum corneum and making the pores smaller by reducing the amount of debris in them.
• the pre-treatment period is one to four weeks, preferably two weeks with retinoic acid being applied twice a week with at least two days in between each application.
• the laser therapy of the present invention will not be effective without the pre-treatment application of topical retinoic acid.
• the second step 11 in the method of the present invention shown in Fig. 1 is the creation of a chronic wound in the high dermis.
• This is produced by a photomechanical laser treatment wherein the laser light does not interact directly with the skin but instead interacts with a contaminant in the skin.
• the contaminant has the properties of absorbing the laser light and exploding.
• the preferred contaminant is carbon or graphite particles in oil 20 which is applied to the skin (see Fig. 2). Once the contaminant or activating solution is applied to the skin, the laser treatment can begin. The energy from the laser is adjusted to be just sufficient to cause the particles to explode.
• the particles explode, they cause the removal of the stratum corneum and the mineral oil 20 penetrates into the epidermis producing hydration of the epidermis by retarding the evaporation of water (see Fig. 2).
• the heat from the explosion of the contaminant particles will induce a photothermal injury in the rete peg area of the high dermis 22 initiating a normal wound healing process.
• the laser treatment is produced several times over a six month period, preferably six times over a six month period. During this first six months the retinoic acid is applied topically twice per week as described above.
• the build up of new collagen in the high dermis 22 in response to the laser treatment and retinoic acid treatment thickens the skin and increases its turgor resulting in smaller skin pores. Broken blood vessels, angiomata, and ice pick scars or suture marks are also minimized, being crowded out by the new collagen. Easy bruisability of the skin is lessened by the collagen build up. Lips become redder, fine lines are minimized, and dark circles around the eyes are minimized.
• the method of process of the present invention is useful in the treatment of sebaceous gland disorders such as acne.
• the secretion from the sebaceous glands is reduced and the smaller skin pore size prevents bacteria from entering the skin pores.
• heat generated from the explosion of the contaminate particles is sufficient to kill bacteria, fungi, and viruses on the skin's surface or in the high dermis. This also allows treatment of conditions such as, for example, plantar warts, herpes cold sores, athletes foot, psoriasis, and excema.
• the process of the present invention for treating the skin is shown in Fig. 3.
• pre-treatment is initiated with topical retinoic acid applied to the skin at least twice per week.
• concentration of retinoic acid in the topical formulation is between about 0.05% to 1%, preferably about 0.1%.
• the pretreatment period is, preferably, two weeks.
• an activating solution of graphite in baby oil is applied to the skin.
• the graphite-oil ratio may range from about 1:1 to 1:9, preferably 1:4, i.e., about 20 percent graphite suspended in about 80 percent oil by weight.
• a laser beam is scanned over the area treated with the activating solution so as to clean substantially all of the mixture from the skin surface by exploding or fracturing the carbon or graphite particles in the oil. This scanning process takes from about 2 to 10 minutes to complete on the face, usually about 4 minutes.
• the wave length of the radiation may range from about 800nM to 2000nM, preferably about 1064nM.
• the frequency of the pulses from the laser range from about 1 to 20 per second, preferably, about 10 per second.
• the duration of each pulse ranges from about .001 to 1 microsecond, preferably about .01 microsecond.
• the fluence or exposure of the skin treated with the activating solution ranges from about 1 to 3 J/cm 2 , preferably, about 2.5 J/cm 2 .
• the laser process is repeated several times to create a chronic wound in the high dermis 22 (see Fig. 2).
• the process may be repeated 2 to 12 times within a six month period, preferably six times.
• retinoic acid is applied to the skin 1 to 4 times per week, preferably 2 times per week, with 2 to 3 days between applications.
• the application of retinoic acid may be varied in an equivalent manner on a monthly basis, i.e., 4 to 16 applications per month, preferably 8 applications per month, where the applications may all be applied within one or two weeks of a given month, but, preferably, applied each week of a month.
• the laser process is repeated at least once in the next six months and thereafter at least once per year, but, preferably twice per year.
• the yearly treatments will maintain a chronic wound in the high dermis.
• topical retinoic acid is applied weekly to the skin as described above. The continued combination of intermittent laser therapy and topical retinoic acid will maintain the rejuvenation and therapeutic results in the skin indefinitely.
• Fig. 4 shows, by way of example, the effects of the laser method of the present invention on the skin of a patient suffering from acne vulgaris.
• the before picture presents the patient's skin prior to treatment and the after picture shows the patient's skin after the first six months of treatment of the skin with the method and process of the present invention.
• the lesions and scars are substantially reduced in severity and the process of acne formation has been completely prevented. Furthermore, this has been accomplished leaving the epidermis intact and normal.
• Continued chronic treatment with the method of the present invention is expected to provide further improvement in the appearance of the skin.
• agents other than retinoic acid which induce collagen and blood vessel growth may be used in place of retinoic acid.
• Any laser system capable of exploding or rupturing a contaminant in the skin without injuring the skin directly can be used in the present invention.
• the activating solution can be made with any suitable oil with any suitable contaminant.

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• 2002
  • 2002-08-28 UA UA20040806798A patent/UA79106C2/uk unknown
  • 2002-08-28 EA EA200400951A patent/EA008608B1/ru not_active IP Right Cessation
  • 2002-08-28 CN CNA028271262A patent/CN1615106A/zh active Pending
  • 2002-08-28 CA CA002472450A patent/CA2472450A1/en not_active Abandoned
  • 2002-08-28 HR HR20040629A patent/HRP20040629A2/hr not_active Application Discontinuation
  • 2002-08-28 WO PCT/US2002/027570 patent/WO2003059144A2/en not_active Ceased
  • 2002-08-28 BR BR0215510-9A patent/BR0215510A/pt not_active IP Right Cessation
  • 2002-08-28 KR KR10-2004-7010917A patent/KR20040075078A/ko not_active Ceased
  • 2002-08-28 PL PL02371247A patent/PL371247A1/xx not_active Application Discontinuation
  • 2002-08-28 AU AU2002332731A patent/AU2002332731B2/en not_active Ceased
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  • 2002-08-28 EP EP02806427A patent/EP1476081B1/en not_active Expired - Lifetime
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