Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N7/00—Ultrasound therapy
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
  • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
  • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
  • A61H23/0245—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with ultrasonic transducers, e.g. piezoelectric
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H7/00—Devices for suction-kneading massage; Devices for massaging the skin by rubbing or brushing not otherwise provided for
  • A61H7/002—Devices for suction-kneading massage; Devices for massaging the skin by rubbing or brushing not otherwise provided for by rubbing or brushing
  • A61H7/004—Devices for suction-kneading massage; Devices for massaging the skin by rubbing or brushing not otherwise provided for by rubbing or brushing power-driven, e.g. electrical
  • A61H7/005—Devices for suction-kneading massage; Devices for massaging the skin by rubbing or brushing not otherwise provided for by rubbing or brushing power-driven, e.g. electrical hand-held
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
  • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
  • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
  • A61H2201/10—Characteristics of apparatus not provided for in the preceding codes with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
  • A61H2201/105—Characteristics of apparatus not provided for in the preceding codes with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy with means for delivering media, e.g. drugs or cosmetics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
  • A61H2207/00—Anti-cellulite devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N7/00—Ultrasound therapy
  • A61N2007/0004—Applications of ultrasound therapy
  • A61N2007/0008—Destruction of fat cells

Definitions

• the invention relates to a method of aesthetic treatment of cellulitis skin by lipotomy, and to a device for the implementation of this method.
• the invention falls within the field of superficial cosmetic skin treatments.
• cellulite skin or “cellulite”, used in the sense of the present invention, refer exclusively to an aesthetic cellulite that causes dents called “orange peel” on the skin. This unsightly “padded” appearance of the skin is due to a very localized hypertrophy of subcutaneous adipose tissue resulting from fat storage.
• the subcutaneous adipose tissue is composed of cells, in particular adipocytes.
• Lipotomy is a method of aesthetic treatment of cellulitic skin whose purpose is to weaken the membrane of adipocytes and ultimately obtain the lysis of this membrane and the destruction of adipocytes.
• the weakening of the cell membranes is obtained by the entry of solvent into the interior of the adipocytes following the induction of an osmotic pressure difference on either side of said membranes.
• osmole is a physical unit for measuring osmotic pressure expressed in moles per liter.
• Osm osmole
• the osmotic pressure corresponds to the difference of the osmotic values on both sides of a semi-permeable membrane by two liquids not having the same richness in dissolved osmotically active molecules.
• Osmolarity is the concentration of dissolved substances in osmotic potency relative to molecular weight, and is also expressed in osmoles. It can be considered that the osmolarity of diffusible electrolytes of the intracellular and extracellular sectors is about 300 mOsm.
• the cell membrane is assimilated to a semipermeable membrane.
• intra-fat administration of a hypotonic solution that is to say a solution whose osmolarity is clearly lower than that of the intracellular medium.
• a flow of solvent in this case water, enters the adipocytes creating a rapid increase in intracellular volume and a thinning of the cytoplasmic membrane, leading to the embrittlement of this cell membrane up to at his break.
• solvent in this case water
• it involves inducing cell destruction that controls the hypo osmolarity caused by the treatment by virtue of safety and efficacy parameters.
• This treatment is applicable to all types of tissue: fatty, cellulitic and tumoral. In the case of cellulite or greasy tissue, the treatment is associated with ultrasound and incidentally with vibrations then taking the name of lipotomy.
• Lipotomy is a technique that, at its origins, could give rise to serious accidents such as tissue and skin necrosis. These accidents generally resulted from an overdose during the administration of the hypotonic fluids used. Although it is now better controlled, the results obtained can nevertheless sometimes show a lack of reproducibility according to the patients and the treated areas.
• the phenomena of osmosis begin to cause the rupture of the cell membranes from a threshold value which is called the "threshold of hypo osmolarity". Moreover, the rupture of the membranes becomes complete below a value which is known as the "limit value".
• the cell membrane of red blood cells serves as a model for all other cells.
• Tests assessing the threshold value and the limit value are part of the general nomenclature of laboratory tests that assess the resistance of red blood cells to hypo osmolarity in order to search for abnormal brittleness.
• the hypo osmolarity or hypotonia of these media in vitro is achieved by a dilution of sodium chloride.
• the osmolar media consist of water for injection as a solvent and sodium chloride as the solute.
• the physiological medium is represented by a solute of 9 grams per liter of solvent.
• the threshold value is reached from 5 grams per liter of sodium chloride and the limit value from 3 grams per liter of sodium chloride.
• the methods of treatment of fatty tissues can be classified in three groups thanks to the following model: i) Group 1: Ineffective treatments, ie carried out at an osmolarity higher than the threshold value, ii) Group 2: Partially effective treatments, ie carried out at a osmolarity between the threshold value and the limit value, and finally iii) Group 3: Totally effective treatments, ie carried out at an osmolarity lower than the limit value.
• Treatments of fatty tissue or cellulitis will seek partial effectiveness while the treatment of cancerous tumors should be of total effectiveness.
• the mode of action acts by osmolar difference between the cell and its environment. This difference is called the "osmolar gradient”.
• GO Osmolarity of the physiological medium (g / 1) - Threshold value (g / 1)
• the osmolar gradient of the threshold value is equal to 9-5, ie 4 g / l.
• the osmolar gradient of the limit value is equal to 9 - 3, ie 6 g / l.
• the partial efficiency is obtained for an osmolar gradient ranging from 4 to 6 grams per liter of sodium chloride solute.
• the total efficiency is obtained from an osmolar gradient greater than or equal to 6 grams per liter of sodium chloride solute.
• the problem is to transpose in vivo in humans the known data in vitro.
• it is absolutely not easy to precisely determine the volume of hypotonic solution to be injected and / or its osmolarity depending on the area of fatty tissue to be treated, which leads to the disadvantages described above.
• the present invention therefore aims to improve the method of aesthetic treatment of the cellulite skin that is lipotomy, particularly in terms of safety and reproducibility, while obtaining optimal efficiency.
• the invention relates to a method for aesthetically treating the cellulitis skin of a patient by lipotomy, characterized in that it comprises at least the following steps:
• Eo is the ultrasound thickness of said fatty tissue at rest
• E p is the ultrasound thickness of said fat tissue compressed to the maximum
• the ultrasound thickness at rest corresponds to the thickness of the hypodermis from the surface of the skin to the muscle membrane (thickness at rest).
• the ultrasound thickness of the maximum compressed tissue corresponds to the thickness of the hypodermis from the surface of the skin to the muscle membrane measured under pressure, for example by pressing the skin with an ultrasound probe.
• the decrease in the thickness of the subcutaneous tissue is initially proportional to the pressure exerted, then, when this pressure reaches a significant value, the thickness of the compressed tissue remains constant regardless of the subsequent increase in pressure.
• a sufficient pressure is therefore applied until a constant compressed tissue thickness value is obtained.
• the calculation of the index IB is carried out by software which determines, from the ultrasound data measured in said steps 2) and 3), at least one of the following parameters: injection mode of the hypotonic solution, ie the injection angle
• the volume of hypotonic solution to be injected is equal to or proportional to the volume of tissue of the zone to be treated.
• the method further comprises an additional step in which the software calculates the osmolarity of the initial interstitial area of the patient from the results of an ionogram.
• This examination consists in determining the plasma concentrations of ions sodium, potassium, calcium, magnesium, chlorine, bicarbonate, as well as the plasma concentrations in proteins and in sugar (Blood sugar).
• the Gibbs-Donnan effect also known as Donnan effect, Doniian's law, or Gibbs-Donnan equilibrium
• This model is applied to the vascular and interstitial sector.
• the vascular sector contains non-diffusible proteins and anions.
• the initial osmolarity of the interstitial sector is equal to the intracellular osmolarity.
• the initial osmolarity of the interstitial sector (B) can be calculated by applying the second Gibbs-Donnan law concerning the equality of the products of the osmolarities of the diffusible anions by the osmolarity of the diffusible cations between the vascular and interstitial compartments.
• the amount of initial solute in milliosmol is given by the following formula (2): Where A is the volume of the initial interstitial sector (expressed in milliliters) and B is the initial osmolarity of the interstitial sector (expressed in milliosmoles / liter).
• Partially effective GO B - H (4)
• the final sodium osmolarity (K) is equal to the sum of the initial amount of sodium in the interstitial area and the amount of sodium injected, all divided by the final volume A + D then multiplied by one thousand.
• the safety index for the aesthetic treatment of fat and cellulite clusters will therefore preferably remain below 55%, keeping a safety margin of 10%.
• the final interstitial hypo osmolarity to be reached in the interstitial sector (H) corresponds to the difference between the initial osmolarity of the interstitial sector (B) and the osmolar gradient to be applied.
• This osmolar gradient is expressed in milli osmoles per liter and in the case of the treatment of cellulite, it will correspond to the values of the osmolar gradient of partial efficiency previously defined.
• the software uses the initial volume of the interstitial sector (A) expressed in milliliters, the initial interstitial sector posmolarity (B) expressed in milli osmoles per liter and the final interstitial hypo osmolarity to be reached (H) in milli osmoles per liter. It is then possible to define:
• D corresponding to the volume of hypotonic solution to be injected
• E corresponding to the osmolarity of the hypotonic solution to be injected
• D is chosen to be equal to the total tissue volume so as to consider the injection as having instantaneous diffusion in A.
• This volume corresponds to a cylinder of length equal to that of the Injection needle and radius called scattering ray.
• the injections being spaced in regular and parallel ways, there is a relationship between the spacing, the needle length, the thickness of the hypodermis at rest, the injection angle and the diffusion radius allowing the cylinders to to be contiguous.
• the volume of the initial interstitial sector A is calculated by the software from the ultrasound data by applying the formula (1) described above (Bernstein index).
• the destruction of the fatty tissue is promoted by the action of ultrasound on the already weakened tissue after administration of said hypotonic solution.
• the lysis of the hyperhydrated adipocytes is thus more easily obtained by causing the destruction of the cell membranes.
• the method according to the invention then further comprises a step of applying ultrasound.
• ultrasound it is preferred to use low frequency ultrasound. Their destructive effects have been attributed to a mechanism of contact cavitation or a simple acoustic tension on weakened membranes.
• the ultrasonic radiation power that can be received by the skin is limited because of the cutaneous tolerance to 3 watts on average per cm 2 of skin.
• the application of higher powers over shorter time ranges is preferably implemented, in order to achieve larger and more effective instantaneous powers.
• an emission time of 0.2 seconds followed by 0.2 seconds of silence allows the application of ultrasonic waves with a power of 6 Watts / cm while respecting the average 3 Watts per cm. 2 tolerated.
• the powers used can reach up to 24 Watts / cm 2 .
• the method according to the invention further comprises a step of applying vibrations to the determined zone. This step is performed on the infiltrated tissues after the injections of the hypotonic solution (draining vibrations).
• the first lipotomies gave rise to undesirable effects such as cutaneous hemosiderosis, the presence of residual fatty nodules or a collection of triglycerides. These are eliminated or greatly reduced by the application of vertical draining vibrations allowing the release of a portion of the injected solution mixed with debris.
• the vibrations are applied perpendicularly to the plane formed by the cutaneous surface.
• the mechanical vibrations are easily transmitted in depth and thus allow optimal drainage of the infiltrated area.
• the power of the apparatus is advantageously between 112 and 450 Watts, preferably 225 Watts.
• a vibration frequency around 12,000 oscillations or a reciprocating cycle per minute with an amplitude of vibratory motion between 0.5 and 2 mm has been found to be the most effective in causing a large outflow of the administered hypotonic solution. .
• Another object of the invention is therefore a device for the aesthetic treatment of cellulitic skin by dermal injection of at least one hypotonic solution into a determined area of fatty tissue to be treated (lipotomy), characterized in that it comprises:
• At least one ultrasound generating device At least one ultrasound generating device
• At least one ultrasound probe capable of measuring the thickness of said fatty tissue at rest and in maximum compression within said zone
• At least one data processing software in particular able to calculate the percentage (IB or Bernstein index) represented by the volume of the extracellular sector of said tissue within said zone according to the following equation (1): in which :
• said device further comprises at least one apparatus generating vibrations perpendicular to the cutaneous surface of said fatty tissue (called vibro-drainer).
• the vibrations applied by this device preferably have a frequency around 12,000 oscillations or cycles per minute.
• the software integrated within this device also calculates, from the ultrasound data, at least one of the following parameters:
• the mode of injection of the hypotonic solution i.e. the angle of injection and the spacing between two injection points, the osmolarity of the hypotonic solution to be administered
• the device further comprises a computer system for controlling and automatically delivering injections of the hypotonic solution whose volume is directly deduced from the ultrasound measurements.
• the ultra sounds are low frequencies and their mode of work allows to deliver instantaneous power of 3 to 24 Watts / square cm while respecting an average power of 3
• FIG. 1 represents a sectional diagram of an area of fatty tissue to be treated on which the hypodermic thickness, the spacing between two injection points, the length of the injection needle, the double of the scattering radius and the injection angle
• FIGS. 2 and 3 are graphs giving the efficacy results of a comparative study of the efficacy of lipotomy treatments of fatty tissues according to methods that are not in accordance with FIG. invention. On these graphs, efficiency and lack of efficiency are functions of the osmolar gradients used.
• EXAMPLE 1 COMPARATIVE CLINICAL STUDY ACCORDING TO A CLASSIC LIPOTOMY METHOD NOT PART OF THE INVENTION
• Each subject was photographed from the front, in profile and the circumference of the area to be treated was measured.
• the areas were then drawn in pencil showing a major axis and a width.
• the injection points were spaced every centimeter in the width direction and to a variable extent between 1 cm and 5 cm in the lengthwise direction depending on the fat tissue thickness.
• the thickness of fatty tissue was then measured by an ultrasound probe, at the level of the maximum thickness and the minimum thickness of the area to be treated, and at rest and in a compressed position. Ultrasound measurements and biological analysis results were captured by treatment software.
• the osmolarity gradients applied ranged from 99 milliliters per liter to 170 milliliters and the interstitial osmolarity coefficient of sodium was calculated by always keeping it below 55%.
• the strips and the ultrasonic heads were sterilized by soaking in a cold sterilization bath.
• the treatment flasks were hooked to a gallows while the injection equipment was resting on a sterile field.
• the vibro-draining apparatus was placed in a sterile envelope.
• the first dermo-epidermal injections were first performed in order to anesthetize each point using the 0.3 / 13 needles and the hypotonic treatment solution cooled to 5 ° C. Then the hypotonic solution was injected with 0.8 / 50 needles according to the software information and filling the syringe with the three-way stopcock.
• a garment of contention was worn by each subject for one month during the day only.
• EXAMPLE 2 HIGHLIGHTING THE IMPORTANCE OF THE INJECTION ANGLE
• Example 2 The results of the study presented above in Example 1 were repeated by eliminating all the oblique injections performed without indication of injection angle and retaining only injections perpendicular to the cutaneous surface. The results obtained are shown in the appended FIG. 3 on which the efficiency or the inefficiency of the method is given according to the different osmolar gradients used.
• the efficiency range of the osmolar gradient is relatively low, about 10 milliosmoles / liter, which gives importance to the ionogram evaluating the initial interstitial osmolarity since it is likely to vary. the gradient of 13 milliosmoles / liter as we saw above in Example 1.
• the method according to the invention improves the current lipotomy method, in particular its reproducibility and its safety. implementation provided that a strict parameter setting is respected.
• lipotomy is a good alternative to lipo aspiration.

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• 2008
  • 2008-05-30 US US12/995,329 patent/US8328722B2/en not_active Expired - Fee Related
  • 2008-05-30 EP EP08805626A patent/EP2296762A1/de not_active Withdrawn
  • 2008-05-30 WO PCT/FR2008/000736 patent/WO2009144389A1/fr active Application Filing

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