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
  • 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
  • A61M37/0092—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • 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
  • 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
  • A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents

Definitions

• the present invention relates to a device capable of generating the phenomenon of cavitation and intended for medical and / or aesthetic applications.
• the present invention will be more particularly described with respect to an ultrasound device comprising an ultrasonic source. It nevertheless applies to any device comprising a means creating cavitation, this means being for example a source of mechanical waves causing acoustic cavitation, or constituted by a helix generating a high velocity flow in a fluid which will cause appearance of a hydrodynamic cavitation.
• cavitation is understood in the rest of the description as corresponding to the birth and oscillation of bubbles of gas or vapor in a fluid, created by the presence of a negative pressure field in this fluid.
• This cavitation phenomenon is created when a vibratory threshold is reached causing the birth, the growth, the oscillation and eventually the bubble implosion of a liquid subjected to pressure waves, such as ultrasonic waves.
• This phenomenon depends on several parameters to be taken into account: the frequency, the intensity, the probe / target area distance and the viscosity of the coupling medium. Cavitation is caused more precisely when ultrasonic waves are used at low frequencies and for high ultrasonic power.
• This phenomenon and the transmission of ultrasound through a biological membrane for example, require a liquid or viscous coupling medium disposed between the end of the probe and the target area.
• the problem encountered in order to obtain a suitable cavitation is the control and control of the distance required between the end of the probe and the target area such as, for example, a surface of a biological membrane. Indeed, a too small distance causes a trauma of the surface of said membrane as well as pain, and, on the contrary, a too large distance is inefficient.
• This pain / efficiency limit related to the probe distance / target zone is a difficult parameter to control in order to effectively use the cavitation phenomenon.
• the difficulty lies in the definition of the good distance which is a function of the device generating the cavitation, in particular for an ultrasonic device, the frequency, the power of the ultrasound, the size of the probe, etc., the viscosity of the coupling medium (mechanical properties) and the morphology (structure, thickness, flexibility) of the target area.
• the application of the probe or a positioning guide of the probe disposed on the place to be treated creates a bead of the non-negligible target area.
• U.S. Patent No. 6,620,123 relates to a specific form of ultrasonic transducer to achieve homogeneous cavitation on the surface of the target area.
• the notion of transducer distance / target area is not mentioned.
• U.S. Patent No. 6,487,447 relates to a device for improving in vivo sonophoresis, comprising a reservoir having an end covered with a porous membrane and containing an active solution.
• the ultrasonic probe is applied with ultrasound intensity to a desired area for a specified period of time and at a distance from the skin surface to generate cavitation bubbles to cause pore formation on the surface of the skin.
• This known device proposes to limit the deformation of the target zone by the presence at the lower end of the reservoir of the membrane maintaining a constant distance between the skin and the probe.
• the present invention overcomes the disadvantages of the prior art by providing a device for adapting the distance of the probe relative to the target area according to the cavitation generated and the morphology of the target subject.
• the purpose of the present invention is to remedy the disadvantages mentioned above and for that purpose consists of a device for medical or aesthetic use, capable of generating cavitation on the surface of a target zone, such as tissues and / or biological membranes so that to modify them, comprising a body integrating a source intended to generate cavitation, that is to say a source creating a depression in a fluid to generate cavitation, said source comprising at least one displacement means, characterized in that that the displacement means is self-adjusting according to the cavitation phenomenon to be generated.
• said source can be kept free (free to move) or mobile inside said body, according to at least one degree of freedom.
• said self-adjusting displacement means may be at least one axial translation means inside said device, along an axis intended to be substantially perpendicular to the surface of the target zone.
• Said axial translation means is at least one resilient means and / or at least one guide and / or at least one stop.
• said at least one guide according to the invention may be a clamping ring, a worm, a groove or a notch.
• Said at least one stop may be formed by a stop, a lug, a projecting element, a washer or a configuration itself of said T-shaped source.
• said device according to the invention can be integrated within an outer body thus constituting handles.
• said source and said body can be linked and move together freely and axially within said outer body.
• said outer body may comprise at least one elastic means and / or at least one guide and / or at least one abutment and / or at least one ball bearing.
• the device is for example an ultrasonic device whose source is an ultrasonic source for generating acoustic cavitation.
• the device is a device whose source generates mechanical waves.
• the source of the device of the invention comprises a helix intended to generate a hydrodynamic cavitation.
• Figures 1 and 2 are partial schematic representations in section of a device adapted to generate the cavitation phenomenon according to the invention illustrating its operating principle on a firm biological membrane;
• Figures 3 and 4 are partial schematic sectional representations of the device according to the invention illustrating its principle of operation on a flexible biological membrane;
• FIG. 5 is a partial schematic sectional view of the device according to the invention.
• FIG. 11 is a partial schematic sectional representation of the device according to the invention according to another embodiment.
• the present invention relates to a device 1 for medical and / or aesthetic use and capable of generating cavitation, such as an ultrasonic probe, intended to modify biological tissues and / or membranes.
• a device 1 for medical and / or aesthetic use and capable of generating cavitation such as an ultrasonic probe, intended to modify biological tissues and / or membranes.
• a body 2 comprising a body 2 incorporating a source capable of creating a depression in a coupling fluid for generating cavitation, in particular an ultrasonic source or a transducer 3.
• modifying the biological tissues and / or membranes, the transformations (with or without alterations), the possible interactions and / or actions that can be performed via a device generating cavitation.
• modify can be interpreted for use of said device for:
• permeabilizing biological tissues in order to facilitate a transmembrane administration of active substances (sonophoresis), for example, and / or to create a thermal, mechanical or physico-chemical stimulation (sonostimulation), biological tissues or their constituents and / or,
• the device according to the invention or probe 1 makes it possible to produce a cavitation phenomenon 4.
• Said probe is applied via its lower part to a surface (or zone) of interest (or target) 5 via a coupling medium 6 (known per se) necessary for the transmission of the ultrasonic waves and to generate the cavitation.
• the body 2 of the probe 1 has an axis of symmetry which, during use, is substantially perpendicular to the plane of the zone of interest 5. Said body of said probe can take any desired shape in order to adapt to all possible applications where a painless cavitation phenomenon is necessary.
• the area of interest may be the surface of a biological membrane, such as a desired or treated portion of the superficial dermis such as a human forehead or for cleaning a wound.
• the ultrasonic source 3, included within said body 2, has a lower end or nose for transmitting ultrasound.
• the ultrasonic source 3 produces ultrasound of high power and low frequencies, in order to generate said cavitation phenomenon.
• the body 2 of said probe is in contact with said desired surface 5 of a firm biological membrane, that is to say that this surface has no deformation during the displacement of the device according to the invention .
• Figure 1 shows the device according to the invention at rest, that is to say without ultrasound emission and Figure 2 in operation, that is to say during ultrasound emissions.
• the ultrasonic source 3 lies axially in equilibrium inside the body 2 and arrives at the lower end of said body and is in contact with the surface of interest 5 via the coupling medium 6.
• the ultrasonic source 3 due to cavitation, takes another position inside the body 2 so to adapt to the surface 5 of the membrane of interest and cavitation 4 generated, to obtain an efficiency of cavitation while being painless (and without leaving the coupling medium 6).
• the ultrasonic source 3 When it is put into operation, the ultrasonic source 3 creates a mechanical wave which, when it comes into contact with the coupling fluid produces the phenomenon of cavitation (or cavitational cloud).
• the latter by bearing on a fixed target, here the surface of interest 5, causes the displacement of the ultrasonic source in the opposite direction to the direction of propagation of the mechanical wave.
• the ultrasonic source that moves freely in the probe then comes off a distance "d" from the target.
• the intensity of the force that causes the displacement of the ultrasonic source is a function of the intensity of the mechanical wave (and therefore the power of the ultrasound), the morphology of the surface of interest and the characteristics of the medium of the ultrasound. coupling.
• the end of the source remains continuously in contact with the coupling medium so that cavitation is maintained.
• the ultrasonic source it is naturally maintained at a height of equilibrium (distance "d") which corresponds to the cancellation of the forces which respectively cause the spring to rise and are due to the self weight of the probe.
• the distance "d" corresponding to the elevation or uplift of said ultrasonic source 3 is between 1 micron and 5 cm.
• the ultrasonic source 3 is movable in the body 2 and can translate, axially, inside said body of the probe 1, in the axis of propagation of the ultrasonic waves when it is in operation, and thus substantially perpendicular to the surface of the area of interest.
• Figures 3 and 4 are partial schematic sectional representations of the device according to the invention illustrating its principle of operation on a flexible and / or non-planar biological membrane.
• Figure 3 shows the device according to the invention at rest, that is to say without ultrasound emission and Figure 4 in operation, that is to say during ultrasound emissions.
• the body 2 of the probe 1 is disposed on a surface 5 of a flexible membrane, that is to say that this surface has a deformation, at the lower end of said probe during its passage or displacement .
• Said ultrasonic source generates a cavitation in the coupling medium 6 on the surface of the target membrane 5 and rises by a variable height in the body 2 of the probe 1.
• the distance "d" between the lower end of the ultrasound source and the target surface 5 is variable, and depends on the cavitation phenomenon.
• the device according to the invention makes it possible to adapt the distance of the ultrasonic source with respect to the target zone as a function of the cavitation generated and the morphology of the target subject and this, self-regulating throughout its use.
• the resonance frequency may be between 10 and 100 kHz and the acoustic power between 0.1 and 50 W.
• the ultrasonic device according to the invention can operate in pulsed mode or in continuous mode.
• Figure 5 is a partial schematic sectional view of the device according to the invention.
• the ultrasonic source 3 is, for example, of generally elongate or tubular shape and collinear with the body 2. Its lower end allows it to transmit the ultrasound via the coupling medium 6 to the surface 5 of interest, and its body or its upper part allow it to have, to include or integrate at least one positioning means or self-adjusting displacement according to the cavitational phenomenon.
• said ultrasonic source 3 can take any desired shape, parallelepipedal, oval, conical or other, so as to adapt to all types of probes of all shapes and therefore to all types of applications.
• the configuration of said ultrasound source is T-shaped and defines a means of displacement and / or positioning allowing it to be maintained at a limiting height inside the body 2 where it is integrated freely or mobile in at least one axial direction (or degree of freedom) of the body 2 of said probe.
• Said ultrasonic source 3 can thus evolve axially with respect to said body 2.
• said at least one self-regulated displacement means as a function of the cavitation produced allows said ultrasound source to be free or mobile in at least one degree of freedom within said body of said probe.
• said at least one self-adjusting positioning or displacement means consists of at least one axial translation means.
• Said at least one moving means may be at least one guide 7 and / or at least one stop 8 provided on the ultrasound source 3 and / or inside said body 2 in order to guide said ultrasonic source during its axial displacements in function of cavitation produced on the surface of a membrane.
• said at least one moving means is at least one elastic means 9 (see FIGS. 7, 9 or 10).
• the device according to the invention comprises at least one guide means 7 and / or at least one resilient means 9 and / or at least one stop 8.
• the ultrasound source may be designed in a substantially tubular form and said guide 7 and / or said abutment 8 may be located on either side or around or all along the perimeter of said ultrasonic source and on a part of said body.
• Said guide 7 may be formed on or for said ultrasonic source.
• Said guide 7 may be in the form of a clamping ring or worm or a notch or groove adapted to cooperate with a notch or groove located on the upper part, or along the ultrasonic source 3 so to guide the latter during its axial translation.
• said stroke of said ultrasonic source is always performed substantially axially without being offset laterally.
• said guide 7 is provided inside said body of the probe 1.
• guides 7 are provided on the ultrasonic source 3 and inside said body 2 and are able to cooperate together.
• Said abutment 8 may be provided, as illustrated in the figures, so as to form the ultrasonic source itself (T-shaped).
• said stop 8 is provided on said ultrasonic source.
• said stop 8 is located inside the body 2 and is able to cooperate with said ultrasonic source.
• said at least one guide means 7 may comprise or integrate or itself form at least one abutment 8 that is located inside the body 2 and / or on the ultrasonic source 3.
• said device 1 comprises at least one abutment 10 provided on said ultrasonic source, in the form of at least one abutment, a lug or a projecting element, such as, for example, a washer adapted to cooperate with the ultrasonic source. 3, or a screw thread or any other means of known type able to come against or cooperate with at least one other abutment 11 provided inside the body 2 of the probe 1 so that said ultrasonic source does not not not a significant axial translation causing a malfunction or a breakage or even its destruction resulting, for example, the overturning of said device during its transport, or the rotation of said ultrasonic source within said body.
• Said abutment 8 is arranged in such a way that its positioning does not modify or prevent the axial displacement of the ultrasonic source 3 as a function of the cavitation generated when said probe is in operation.
• the ultrasonic source 3 is left or kept free or movable inside the body 2 with no other moving means than its guide and / or its abutment and / or elastic means.
• the force of the moving means can be defined as a function of the mass of said ultrasonic source, the type of displacement means, the nature of the coupling means, and the axial variation of the desired source within said body.
• said ultrasonic source self-regulates in height according to the cavitation generated, and thus, the morphology of the target area while permeabilizing or treating biological membranes or tissues, for aesthetic applications and / or medical.
• Figures 6 to 10 are partial schematic sectional views of different embodiments of the device according to the invention.
• Figure 6 shows another possibility of operation of the guides.
• said guide 7 has ball bearings 12 in a screw thread. These reduce the friction inside said guide.
• FIGS. 7 and 8 illustrate another embodiment in which the upper part of the ultrasonic source 3 is connected to the upper inner end of the body 2 of the probe 1 by at least one elastic means 9 allowing said ultrasonic source to be held in place at rest but also to be recalled, to ensure the return to the initial position of said ultrasonic source, once the cavitation is completed, and to be maintained at a height according to the cavitation generated and the morphology of the area of interest, throughout its operation.
• Said at least one resilient means 9 may be disposed at the ultrasonic source 3 at its upper end but also at its upper part and / or its lateral parts.
• Said at least one resilient means 9 may be an elastic system, a return spring 13 or a hydraulic type spring 14 or compression or any other type of elastic means of known type.
• FIGS. 9 and 10 show an ultrasonic source 3 held in place inside the body 2, via at least one elastic means 9 located between said abutment 11 of the body 2 of said probe and that or those of said ultrasonic source or located between said guide 7 of said ultrasonic source and said stop 10 of said ultrasonic source.
• the elastic means 9, serve as pushing and / or return for said ultrasonic source 3. They are used to compensate the mass of said ultrasonic source so that the latter is in equilibrium and can move under the effect and according to the cavitation produced.
• Figure 11 is a partial schematic sectional representation of the device according to the invention according to another embodiment.
• This figure illustrates another embodiment where the body 2 of the probe 1 integrating the ultrasonic source 3 is itself integrated inside another external body, second body or handles 15.
• this configuration comprises an outer body 15 in which slides, axially, the probe 1 comprising said ultrasonic source 3 and said body 2 fixed to one another.
• the body 2 of said probe and the ultrasonic source 3 are intimately connected and no longer move relative to each other. Indeed, the latter cooperate together, by an axial translation movement, according to the cavitation generated according to the morphology of the studied surface relative to the second body 15 which itself remains stationary relative to the surface of interest.
• the body 2 and the ultrasonic source 3 are fixedly fixed to one another via screws 16, for example, in the stops 8.
• guides 7 may be provided as previously illustrated.
• At least one seal may be provided between the guides 7 and the abutments 8.
• the outer body or handles 15 remains stationary and it is the ultrasonic source 3 and the internal body 2 that become self-adjusting, depending on the cavitation generated enabling permeabilization or treatment of biological membranes or tissues, for aesthetic applications. and / or medical.
• this last embodiment may include other elastic means 17 arranged for pushing or returning to the initial position of the body 2 and the ultrasonic source 3 inside the handles 15 in order to guide the latter during their translational movements and to prevent them from being offset laterally.
• said body 2 and said ultrasonic source 3 disposed via the handles 15 on a target membrane surface 5 cause cavitation in the coupling medium 6 and rise or rise from a variable height in the body external or handles 15 relative to the surface 5 of the membrane of interest and relative to the lower ends of said handles.
• At least one guide 18 and / or at least one abutment 19 and / or at least one additional resilient means 17 capable of cooperating with those that can be provided can also be provided inside the handles 15. outside the body 2.
• ball bearings 20, or any other means that can reduce friction, may also be provided.
• the device capable of generating cavitation according to the invention describes several embodiments for illustrative purposes. It is understood that one skilled in the art is able to make other variants of the device according to the invention without departing from the scope of this patent.
• the device according to the invention has several types of applications. Indeed, it is used for membrane permeabilization for example, and quickly, efficiently, secure, reproducible and reversible.
• the use of the device according to the invention makes it possible to generate cavitation without pain, without the need to add chemical promoters, and makes it possible to administer molecules in a transmembrane manner, for example.
• the device according to the invention has a metabolic action, activating or stimulating fibroblasts of the superficial dermis, for example, via the cavitation generated.
• the present invention also makes it possible to increase the time of action of the device on a target area for a longer stimulation since the cavitation generated is painless.
• the device according to the invention can be used to clean superficial wounds or to accelerate or sublimate healing or even a potential application in surgery.
• the device according to the invention can also be used for aesthetic purposes, such as, for example, to improve the elasticity, the hold, or the appearance of the skin (exfoliation, abrasion, skin cleansing, skin aging, skin repair). orange, cellulite, etc.) or pain (osteoarthritis, joint stiffness, sprains or muscle injuries, etc.).
• said device may also have an application in the treatment of membrane or biological tissue surfaces in dermatology, such as, for example, the treatment of warts, or acne (deep pore cleansing), etc.
• the coupling medium may contain active molecules.

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• 2008
  • 2008-01-25 FR FR0800394A patent/FR2926731B1/fr active Active
• 2009
  • 2009-01-23 WO PCT/FR2009/050102 patent/WO2009095597A2/fr active Application Filing
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