US20090143773A1 - Device for assistance in the wound healing processes - Google Patents

Device for assistance in the wound healing processes Download PDF

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Publication number
US20090143773A1
US20090143773A1 US12/270,237 US27023708A US2009143773A1 US 20090143773 A1 US20090143773 A1 US 20090143773A1 US 27023708 A US27023708 A US 27023708A US 2009143773 A1 US2009143773 A1 US 2009143773A1
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approximately
skin
laser
treated
laser source
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US12/270,237
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Inventor
Alban Gosse
Sylvain Giraud
Gwenaelle Iarmarcovai
Alain Cornil
Alexandre Capon
Patrick Peronne
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Vivatech Co
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Ekkyo
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Publication of US20090143773A1 publication Critical patent/US20090143773A1/en
Assigned to VIVATECH reassignment VIVATECH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: EKKYO
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    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
    • 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
    • A61N5/0616—Skin treatment other than tanning
    • 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
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • 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
    • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0659—Radiation therapy using light characterised by the wavelength of light used infrared
    • 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
    • A61N5/067—Radiation therapy using light using laser light

Definitions

  • the invention is related to the field of assistance in skin wound healing, and in particular to assistance in wound healing processes using a laser beam.
  • EP265470 a device is known, which is used for uniting the lips of a wound. It includes a laser whose emission wavelength is chosen such that it can perform tissue bonding and unite the lips of the wound, and a holding piece suitable for being secured to the tissue around the wound so as to hold the lips of said wound in contact, at least while the wound is exposed to said laser radiation.
  • the key idea is to unite both skin and vessels, by using sufficient laser energy to achieve an increase in tissue temperature beyond 60° C., suitable for denaturing and achieving interdigitation of the collagen fibres.
  • This temperature is currently acknowledged to be the level above which irreversible heat damage is caused if tissue is heated for longer than one second, leading to tissue coagulation and necrosis through burning, such as to slow and reduce the quality of the healing process.
  • the aim of the present invention is to solve the aforementioned problem, by offering a device for assistance in the wound healing process that takes into account the different skin types that are laser-treated in order to optimise the effectiveness of the wound-healing processes and to avoid any burning.
  • the invention provides a device for assistance in the skin wound healing process, comprising a laser source suitable for emitting a beam whose wavelength is between approximately 800 nanometres and approximately 820 nanometres.
  • the device of the invention includes a control module suitable for controlling the laser source according to data regarding the skin type of the patient to be treated.
  • Laser source is here understood to refer to the device emitting the beam that is focused on the skin to be treated.
  • the laser source includes, in particular, the laser diode(s) and the optical means used to shape the radiation emitted therefrom.
  • Control is here understood to refer to any type of control or command influencing the characteristics of the beam focused on the skin. Such characteristics may for instance include the power, duration, shape or speed of movement of the laser beam.
  • control module is suitable for controlling the laser source according to the skin phototype of the patient to be treated.
  • control module is suitable for controlling a laser source such that it emits, for a duration of less than 20 seconds, a fluence of:
  • control module is suitable for controlling a laser source such that it emits radiation for a duration that varies according to the phototype, whereby the duration will, in particular, decrease as the phototype number (category) increases.
  • control module is suitable for controlling a laser source such that it emits:
  • the control module is suitable for controlling the laser source according to the lightness of the skin area to be treated.
  • the parameter L* (for lightness) is part of the L*a*b* colour space description created by the International Commission on Illumination.
  • control module is suitable for controlling a laser source such that it emits, for a duration of less than 20 seconds, a fluence of:
  • control module is suitable for controlling a laser source such that it emits radiation for a duration that varies according to the lightness value of the skin area to be treated, whereby the duration will, in particular, increase as the lightness value increases.
  • FIG. 1 is a graph illustrating a logarithmic relationship between exposure time and temperature for inducing a heat shock response
  • FIG. 2 is a graph illustrating the different phases of healing for a cutaneous wound
  • FIG. 3 is a graph illustrating the different absorption coefficients of the main chromophores, as a function of laser source wavelength
  • FIG. 4 is a graph illustrating the skin penetration (percentage depth) of a laser beam as a function of wavelength
  • FIG. 5 is a graph illustrating the influence of skin phototype on skin temperature elevation
  • FIG. 6 is a graph illustrating the influence of skin lightness on skin temperature elevation
  • FIG. 7 is a graph showing a conventional laser beam profile and a laser beam profile as claimed in the invention.
  • FIG. 8 gives a schematic illustration of a laser beam conversion device as claimed in the invention
  • FIGS. 9 and 10 are diagrams illustrating a dermatological treatment device as claimed in the invention.
  • FIG. 11 is a simplified diagram of a safety strip as claimed in the invention.
  • FIG. 12 illustrates the design that could be printed on a safety strip as claimed in the invention
  • FIG. 13 is a schematic representation of the communications between an RFID component and the two microcontrollers in a device as claimed in the invention
  • FIGS. 14 a to 14 c are graphs illustrating various temperature increase scenarios on the surface of an area of treated tissue.
  • FIGS. 15 and 16 are logic flowcharts showing the processes at work in the microcontrollers in a device as claimed in the invention.
  • the invention is based on moderate heating to provide heat treatment to a limited volume of cutaneous tissue surrounding and including a present or future cutaneous lesion (a future lesion, for instance, in the case of surgical incisions).
  • the invention does not provide for the selective heating of one or more skin constituents, but describes heating the whole of a volume located throughout the thickness of the skin (epidermis, dermis, upper layer of the subcutaneous tissue) in order to generate a biological response to the heat stress or thermal conditioning throughout the tissue.
  • the choice of beam and all related parameters is therefore based on these specifications.
  • FIG. 1 illustrates a logarithmic relationship between exposure time on the y-axis (units in seconds) and the temperature for inducing a heat shock response along the x-axis (units in degree Celsius).
  • Heat shock response is a cellular mechanism used to maintain stability when a shock (e.g. heat shock) is undergone.
  • the heat shock response often involves the production of heat shock proteins (HSP), a protein group that can help accelerate the healing process.
  • HSP heat shock proteins
  • the invention does not aim to alter the cell structure, but to influence the healing process by inducing HSP production. Indeed, uncontrolled hyperthermia can quickly lead to tissue damage and consequently to tissue denaturing and destruction.
  • the invention provides for induction of a localised fever whose maximum temperature is controlled to prevent tissue damage.
  • thermal conditioning is induced such as to alter the inflammatory process.
  • a source of electromagnetic energy such as a laser
  • thermal conditioning is induced such as to alter the inflammatory process.
  • the link between a controlled temperature increase (moderate hyperthermia), HSP production and the inflammation process has been established in the prior art.
  • the healing process involves three phases following the initial thrombosis:
  • the x-axis of this graph shows the time since start of healing and the y-axis shows a level of response to a given heat shock and hence a level of HSP production.
  • a laser beam skin wound treatment process consists of directing light energy onto the tissue with the aim of generating moderate and controlled hyperthermia as early as possible in the healing process in order to prevent scarring and accelerate tissue regeneration, rather than correcting this scarring once the scar itself has appeared.
  • the time at which the wound is treated must therefore be selected carefully with respect to the inflammation phase.
  • An optimum treatment window should be defined, to ensure that the peak of HSP production coincides with the inflammation phase. Since the HSP production peak may occur up to 24 hours after heat stress has been undergone, the conditioning treatment may take place up to 24 hours before the lesion appears.
  • FIG. 3 is a graph with three curves showing the energy absorption coefficient (y-axis) as a function of the energy wavelength (x-axis) for the following skin constituents: melanin, shown as curve 301 , haemoglobin, shown as curve 302 , and water, shown as curve 303 .
  • FIG. 4 is a graph showing the rate of absorption of each skin layer for various wavelengths.
  • the wavelength must be greater than 800 nm in order to pass through this layer without being fully absorbed.
  • haemoglobin is the predominant chromophore and is therefore highly absorbent.
  • red and near-infrared wavelengths between 600 nm and 1000 nm
  • there is relatively little absorption since neither water nor blood absorb energy at these wavelengths.
  • absorption in water is extremely high and this absorption becomes the predominant factor.
  • the range of wavelengths to be used must therefore be between 800 nm and 1800 nm. In a preferred embodiment, the wavelength will be 810 nm or 910 nm. Advantageously, wavelengths of 1200 nm would minimise the absorption by melanin, but current technology does not provide a sufficiently powerful beam from laser diode source at this wavelength.
  • FIGS. 5 and 6 illustrate the influence of skin type on the temperature reached by said skin under laser illumination at a wavelength of 810 nanometres.
  • FIG. 5 shows skin temperature curves as a function of laser fluence in joules per cm 2 for patient with different skin phototypes.
  • the fluence of the beam is the energy transmitted per cm 2 .
  • curve C 1 describes skin of phototype V
  • curve C 2 describes skin of phototype IV
  • curves C 3 , C 4 and C 6 all describe skins of phototype III
  • curve C 5 describes skin of phototype II.
  • Phototype is a numerical classification of skin type that is well known in the field of dermatology. It takes into account a person's genetic disposition, reaction to sun exposure and tanning habits. Skin phototype, as determined by the score given in the Fitzpatrick skin typing test, is commonly used by healthcare professionals and can help support various diagnostic and treatment procedures for the skin.
  • the fluence should be transmitted for a duration that is less than a specified threshold, in order to promote effective skin heating, leading to the desired healing effect.
  • a maximum fluence transmission time of less than 20 seconds is suitable for achieving the desired heating effect. Beyond this duration, the heating is too shallow.
  • the exposure time can, for example, be managed by controlling the duration of the laser pulses.
  • the spread of temperature values observed in a group of people with the same phototype may have various causes.
  • the Fitzpatrick skin typing test does not only take into account skin colour, but also considers criteria such as eye and hair colour, skin reaction to sunlight or tanning habits.
  • phototype values given by the Fitzpatrick test are a good indicator, enabling the fluence of the laser treatment to be adjusted without requiring any specific equipment for detecting skin type, the precision of the phototype scale remains somewhat limited.
  • FIG. 6 shows skin temperature curves as a function of laser fluence in joules per cm2 for skins with different lightness values, as measured with a conventional chromameter.
  • said fluence should be transmitted for a duration of less than 20 seconds in order to produce the desired healing effect.
  • the inventors also noted that the darker the skin is, the longer the duration of fluence transmission that should be applied. Indeed, with dark skins, the transmission of light energy over a short duration has the effect of heating surface layers of the skin rather than heating in depth. If the illumination is spread over time, the skin is heated by thermal diffusion.
  • the laser beam is controlled such that its duration varies according to the phototype, whereby the duration will in particular decrease as the phototype number (category) increases. More particularly, once the fluence has been determined according to skin phototype, it is preferable to have illumination for approximately 5 seconds to approximately 15 seconds when the skin phototype is of category I, II, III or IV and illumination for a duration of greater than 10 seconds and less than 20 seconds when the skin phototype is of category V or VI.
  • the laser beam is controlled such that it varies according to the lightness value of the skin area to be treated, whereby the duration will in particular increase as lightness increases.
  • the shape of the laser spot must also be studied in order to provide deep heating and stimulate all tissues involved in the skin wound healing process: the subcutaneous tissue, dermis, and epidermis. Since depth is near-proportional to the laser spot diameter, a diameter greater than or equal to 3 mm will be preferred in the case of a round spot. Ideally, the spot shape could also be tailored to the geometry of the area to be treated, to enable the most homogeneous distribution possible of light energy within the target tissue. In a preferred embodiment, a rectangular spot shape whose width is at least 3 mm and whose length may be several centimetres will be selected, in order to treat linear wounds.
  • the invention additionally relates to the temperature precision achieved within the heated volume.
  • the digital model developed can be used to optimise all parameters and achieve a minimum temperature of 45° C. (temperature required to induce heat stress) and a maximum temperature of 55° C. As described in the prior art, temperatures in excess of 60° C. can induce protein denaturing and therefore counteract the desired effect. The maximum temperature of 55° C. means that this threshold value will not be exceeded.
  • a conventional Gaussian beam profile is not the most suitable profile. Indeed, as the name suggests, the energy distribution is similar to a Gaussian function, which has the direct effect of heating the skin surface in a non-uniform manner, with a major temperature peak in the centre of the irradiated zone. The temperature gradient will therefore be too great with respect to the temperature range in which it is desirable to operate.
  • a flat-top (or top-hat) profile ( 510 ) is consequently to be preferred to a Gaussian profile in order to ensure the skin surface temperature is homogenised, as is the temperature of the heated volume.
  • This flat-top power profile shown as curve 510 , gives a more homogeneous heating effect throughout the heated area, rather than a selective heating action.
  • This profile is defined by three components:
  • a flat-top profile is a minimal rate of variation ( 516 ) along the wavefront width, with a maximal wavefront width-to-FWHM ratio.
  • a flat-top profile will have a rate of variation of less than 5% and a ratio of wavefront width-to-FWHM of greater than 90%.
  • the spot shape will depend on the medical indication. In a preferred embodiment and in a configuration chosen for treating incisions, the spot dimensions will be 20 mm by 4 mm, and the rate of variation less than +/ ⁇ 20% of nominal power ( 518 ).
  • the invention provides a means for shaping the laser beam emitted by the diode (since on output from the diode the laser beam has a Gaussian profile).
  • An example of such a system is shown in FIG. 8 .
  • the laser beam shaping means ( 61 ) is positioned downstream of a laser diode ( 62 ), advantageously characterised in that its emission width is 200 ⁇ m by 5 ⁇ m and its divergence is 8 ⁇ 35°.
  • An optical fibre ( 63 ) positioned in front of the diode acts as a cylindrical lens to reduce divergence of the diode's fast axis advantageously to approximately 5°.
  • the laser beam then passes through the laser beam shaping means ( 61 ), which includes a system of two lens arrays ( 64 ) and a cylindrical lens ( 66 ), which splits the original beam into as many beams as there are lenses in the lens array ( 64 ). Each sub-beam is focused at the desired distance and all these beams are then superimposed to achieve a flat-top profile.
  • the beam's focal distance depends chiefly on the focal length of the cylindrical lens.
  • the homogeneous nature of the profile depends however both on the focal length of the cylindrical lens and on the focal length of the two lens arrays.
  • the input beam must strike as many lenses in the array as possible (the greater the number of sub-beams formed, the more likely the sub-beams are to tend towards a flat-top profile when combined). There is, therefore, a balance to be struck between the distance between the diode and the first lens array and the angle of divergence, in order to maximise homogeneity of the flat-top profile, whilst reducing the length of the final system.
  • the device In order for the technique to be accessible to as many users as possible, the device is designed to be easy and safe to use under all circumstances and in all locations in which it may be used, from a general practitioner's surgery to the sterile environment of an operating theatre. Since users may travel or make regular visits, the size and portability of the device is also a key factor.
  • the invention provides that the light source is applied as early as possible in the healing process in order to prevent the appearance of scarring, rather than correcting this once the scar has appeared. For this purpose, users need a medical device that can enable early intervention, i.e. directly in the operating theatre in a sterile environment.
  • the medical device should therefore be designed to be small, portable, easy to use with one hand and autonomous (wireless) and further designed to avoid jeopardising the cleanliness or sterility of the environment in which it is used.
  • FIGS. 9 and 10 One embodiment of a device as claimed in the invention will now be described, referring to FIGS. 9 and 10 .
  • a dermatological treatment device ( 70 ) as claimed in the invention includes a closed optical unit ( 722 ), including at least one laser system ( 72 ) comprising a power laser diode whose wavelength is between 800 nm and 820 nm, preferably equal to 810 nanometres and whose power is greater than 1 W and less than 25 W, and conversion means ( 74 ) consisting of a lens array or a phase array.
  • the laser system ( 72 ) and conversion means ( 74 ) are designed to emit a laser beam with the aforementioned advantageous characteristics.
  • Optical unit ( 722 ) may also include a sighting laser ( 73 ), whose power is less than 1 mW for instance, in order for said sighting laser to provide comfort in use and not generate any biological response. In order to ensure this sighting laser ( 73 ) is visible, its wavelength may for instance be between 480 nm and 650 nm (red colour).
  • optical unit ( 722 ) is removable and interchangeable in order to facilitate maintenance of treatment device ( 70 ) and ensure its flexibility (ability to change diode type according to the desired treatment type).
  • the invention therefore provides the device user (e.g. medical practitioner) with a selection of optical units, each of which will have different configurations and all of which comply with the safety-related constraints (the user cannot change the settings himself).
  • Treatment device ( 70 ) also comprises an energy source (battery) ( 71 ) for full autonomy.
  • This battery may be interchangeable.
  • Treatment device ( 70 ) includes one or more electronic circuits ( 710 ) whose function is to manage power supply to the device and the various components in the device.
  • the treatment device includes an RFID reader ( 711 ) (e.g. RFID antenna), used to make the device safe by ensuring that the laser only fires when it is in the vicinity of an RFID component (tag) affixed close to the treatment area, thus preventing any risk of harm for the user, patient and other nearby persons.
  • RFID reader e.g. RFID antenna
  • This system also enhances treatment safety by reading pre-recorded settings from the tag, meaning that the practitioner cannot accidentally change any potentially dangerous parameter (chiefly laser power and firing time).
  • the laser settings are controlled on the basis of information transmitted by the RFID component, which contains configuration data that can adjust the firing power, firing time and number of pulses, according to the user's choices, in order to obtain the fluence values described above according to the skin phototype of the patient to be treated.
  • the user will select the attachment element according to the nature of the treatment to be performed, and the selected tag will transmit a signal or information which will control the laser emissions.
  • the attachment element consists for instance of a patch formed by a piece of adhesive fabric that includes a radio frequency identification (RFID) tag, consisting of an antenna design that enables inductive coupling for power supply to a high frequency component and transmission of a high frequency signal emitted by said component.
  • RFID radio frequency identification
  • the attachment element must be placed close to the treatment zone such that treatment device ( 70 ) is within interaction range of the tag throughout the duration of treatment.
  • the RFID component has an identifier which refers to a settings table in the laser software. This table contains preset values for firing power and firing time and also the type of patient to be treated (for a safety check by the practitioner).
  • the user When using the device, the user simply selects a safety strip (containing RFID components) based on the patient's skin phototype and indication (wound, acne treatment, skin remodelling etc.). Unlike other laser systems on the market, the user cannot adjust the operating settings. Treatment parameters are therefore based solely on the choice of strip containing the treatment identifier.
  • the distance between the RFID component and the treatment device ( 70 ) is between one and fifteen centimetres. This distance is assessed by the limited range of the interaction means between said component and treatment device ( 70 ) or by a range-finder, for instance an ultrasound range-finder integrated in the device.
  • the treatment device also includes a pyrometer ( 712 ), used to monitor the temperature increase that can cause superficial burning (temperature greater than 60° C.).
  • the pyrometer ( 712 ) is used to set up a closed loop on the laser beam.
  • Pyrometer ( 712 ) is in fact a safety component that monitors skin surface temperature. It operates to “lock down” or deactivate laser firing if the temperature reaches a preset threshold value.
  • Pyrometer ( 712 ) can also be used in a more advanced way within a closed control loop in order to readjust the laser settings.
  • the temperature at the surface and deeper in the epidermis will depend on a variety of parameters such as:
  • 1 wavelength, which is a key factor in the absorption and scattering of light by the various chromophores (water, haemoglobin, melanin), 2—laser power, causing heating to a greater or lesser depth, 3—spot shape and size, which influence the heat distribution at depth, 4—beam profile, which has a direct impact on the temperature gradient across a beam cross-section (Gaussian profile, flat-top profile), 5—firing time which, at a given power, the longer it is promotes a thermal diffusion heating system, 6—finally, parameters directly related to the patient, the most significant of which is likely to be the skin phototype.
  • a transparent optical window ( 713 ) in the wavelength range between 480 nm and 1.4 ⁇ m shall be provided.
  • potassium bromide that is transparent from wavelengths from 450 nm to 10 ⁇ m could be chosen.
  • a standby system could be also added to the device, to operate when the device is not used for a preset length of time. Standby mode is interrupted as soon as user presses either of the fire buttons. This type of system saves battery power, on the one hand, but in particular prevents the sighting laser (even a low power laser) from causing eye damage.
  • the treatment device could include a cooling system comprising an internal radiator ( 714 ) connected directly or via a heat pipe to the laser diode.
  • a cooling system comprising an internal radiator ( 714 ) connected directly or via a heat pipe to the laser diode.
  • one possible embodiment of the invention provides a natural and/or forced ventilation device to extract heat generated by the laser diode from the device in a sterile manner in order to avoid jeopardising the sterility of the operating area in which the treatment device ( 70 ) is used.
  • the device could be fitted with a user interface to provide the user with information on the operating parameters (wavelength, settings contained in the RFID component and read by the RFID treatment device, temperature measured by the pyrometer).
  • the user interface on a treatment device of the invention includes the following items:
  • a possible embodiment of the invention provides a removable sterile sleeve ( 80 ) designed to contain the device and isolate it from the external environment.
  • This sleeve can be understood as a sterile casing in which the device is placed in order to ensure that the area in which the device is used remains sterile.
  • removable sleeve ( 80 ) is designed not to interfere with the laser beam.
  • the device shall have a window that is transparent to the predefined wavelengths, in order to allow a beam whose wavelength is within the range of preset wavelengths to pass through.
  • Removable sleeve ( 80 ) is further designed not to interfere with pyrometer ( 712 ) or RFID reader ( 711 ) operation.
  • Removable sleeve ( 80 ) also allows heat extraction without causing a detrimental effect on the sterile environment in which treatment device ( 70 ) is used. Using this sleeve, the laser can be fired without altering the sterility of the sleeve's outside surfaces.
  • the sleeve must obviously be sealed and have a sealed closure system, in order to provide a microbial barrier between the device and its external surroundings. Nevertheless, this sterile barrier must not hinder the extraction of heat generated by the device.
  • the sleeve therefore contains at least two filters (an air inlet and air outlet filter) to allow air circulation inside the sleeve.
  • the sleeve must not hinder access to the device controls (firing buttons, switch, emergency stop button), prevent information from being read (LCD screen, indicator lights) or the device from being gripped.
  • the sleeve shall therefore comprise a rigid section at the bottom of the device for correct positioning and a flexible transparent upper section covering the rest of the device.
  • treatment device ( 70 ) and the lower rigid part ( 87 ) of sleeve ( 80 ) in contact with the treatment area both include a recess ( 83 ) opposite the laser beam output, ensuring there is no direct contact with the patient and therefore no fouling or contamination. This design also ensures a distance between the beam shaping system output and the tissue zone to be treated.
  • the sleeve therefore comprises one rigid section and one flexible section (to be handheld and for easy use of the buttons). It is intended that both sections be made of PVC, with a thickness of between 2 and 3 tenths of a millimetre for the flexible section and a few millimetres for the rigid section.
  • the treatment shall be made safe and controlled by means of a safety strip ( 90 ) containing an RFID chip which will transmit the various operating settings to the laser device, on the basis of the medical indication and skin phototype of the patient to be treated.
  • Said safety strip ( 90 ) which may be produced in several different lengths (e.g. 4, 10 and 20 cm), is affixed approximately 5 mm away from the zone to be treated.
  • the safety strip comprises two adhesive attachment elements: one double-sided adhesive element ( 91 ) and another single-sided adhesive element ( 93 ). These two elements sandwich the RFID components ( 92 ), which are arranged every 2 cm.
  • the safety strip may, for instance, be 2 cm wide.
  • Lower adhesive element ( 91 ) is in contact with the patient's skin. It must therefore be biocompatible and offer appropriate adhesion to the skin during use. Lower adhesive element ( 91 ) must stick to the patient's skin and also bond correctly with both the RFID component and upper adhesive element ( 93 ). The lower adhesive element is therefore a double-sided adhesive.
  • the safety strip manufacturing process shall include a sterilisation stage.
  • Upper adhesive sub-element ( 93 ) must be a single-sided adhesive in order to be assembled with RFID component ( 92 ) and lower adhesive element ( 91 ). As shown in FIG. 12 , information shall be printed on upper section ( 93 ), such as skin phototype, the company name, product number and a scale to help the practitioner gauge progress of the treatment.
  • Upper adhesive element ( 93 ) is designed not to interfere with RFID communication between the RFID reader ( 711 ) (see FIG. 9 ) in the device and the ( 25 ) RIFD components ( 92 ).
  • the RFID components ( 92 ) must comply with the ISO 15693-3 standard. The mandatory and optional sections, as defined by said standard, are to be implemented. Since the RFID transmission range is critical, RFID components ( 92 ) as claimed in the invention shall be such that this value can be fixed once the “RFID component-RFID reader” pair has been selected.
  • the size of said RFID components may for instance be 14 mm ⁇ 14 mm and the thickness less than 1 mm.
  • the EEPROM storage capacity of the RFID component shall be at least 1024 bytes.
  • the production process shall also include sterilisation with ethylene oxide.
  • the device comprises two microcontrollers ( 111 and 112 ).
  • One microcontroller ( 111 ) manages the laser, energy, thermal control and the user interface.
  • the other microcontroller ( 112 ) manages the safety strips ( 90 ).
  • Responsibility for managing the laser firing is shared by both microcontrollers ( 111 and 112 ).
  • the laser may be stopped due to excessive temperature ( 15 ) (managed by microcontroller 111 ) or an emergency stop request (microcontroller 111 ). If the stoppage conditions still apply, laser treatment cannot resume.
  • a pyrometer ( 712 ) stops the laser if the skin temperature exceeds a critical temperature, for instance 60° C. (managed by microcontroller 111 ).
  • a critical temperature for instance 60° C.
  • FIGS. 14 a , 14 b and 14 c These figures are graphs which show temperature curves 120 , 121 and 122 (temperature in degree Celsius on the Y-axis) as a function of heating time (TC, on the X-axis).
  • TC 1 , TC 2 and TC 3 represent the times at which the laser is stopped. If the laser has been stopped ( 25 ) by the pyrometer ( 712 ), it can be authorised to operated once more only, after a safety delay (e.g. 5 seconds), if during the first laser emission, the firing time was less than or equal to half the preset firing time (as managed by microcontroller 112 ). This is the case in FIG. 14 c .
  • the figures therefore illustrate the following scenarios:
  • the end of normal firing should be indicated with a beep (microcontroller 111 ). If the pyrometer ( 712 ) trips before 50% of the time has elapsed, a display on the user interface shall indicate to the user that the laser treatment may be resumed.
  • the laser treatment may be allowed to resume once only, after a 5 second delay. This re-authorisation is valid for a 60 minute period.
  • the presence of an RFID component ( 92 ) is indicated by the TTL pin ( 113 ) on the microcontroller ( 112 ).
  • the presence of an RFID component ( 92 ) gives no information regarding its status.
  • a “read settings” message must be sent to microcontroller ( 112 ). This command requests information on the treatment status of RFID component ( 92 ), which is in range of RFID reader ( 711 ).
  • the status of an RFID component ( 92 ) may be one of the following:
  • Microcontroller ( 111 ) recognises five messages from microcontroller ( 112 ):
  • microcontroller ( 111 ) When the device starts, microcontroller ( 111 ) initialises the clock in microcontroller ( 112 ) with the INIT message. Both clocks are synchronised. At the rising edge of the TTL pin ( 113 ) on microcontroller ( 112 ), microcontroller ( 111 ) requests the laser settings via the PARAM message. Depending on the reply message from microcontroller ( 112 ), the user interface is updated and firing is authorised. During laser emission, microcontroller ( 111 ) indicates progress to microcontroller ( 112 ) with the messages START, STOP and PAUSE. Microcontroller ( 112 ) updates the information in the RFID components ( 92 ) according to these messages. The device clock is managed by microcontroller ( 111 ).
  • RFID component ( 92 ) does not contain the exact date and time, but dating information related to the device start-up. It operates as a timer.
  • the device clock may be reinitialised following extended battery power loss. In this case, if an RFID component ( 92 ) has been treated, its treatment start date is later than the current date. Even if treatment has not been completed, RFID component ( 92 ) is considered as treated.
  • FIG. 15 illustrates a logic flowchart for microcontroller ( 111 ).
  • box ( 1301 ) shows detection of the presence or otherwise of an RIFD component. If not detected, the user interface will indicate that no RFID component was found (box 1302 ). If an RFID component is detected, the “read settings” command is initiated (box 1303 ) to diagnose RFID component status (box 1304 ). If status is OK, the device indicates via the user interface that it is “ready” (box 1305 ), and if the trigger is activated (box 1306 ), then microcontroller ( 111 ) sends microcontroller ( 112 ) the START message (box 1307 ) to indicate that laser emission should be started. The laser is switched on (box 1308 ).
  • the device will indicate that it is on “standby” (box 1309 ) and the process goes back to the start of the flowchart. If the message is TRT OK (treated), the device indicates that the zone has been treated (box 1310 ) and the process goes back to the start of the flowchart.
  • a temperature measurement (box 1311 ) is performed. If the temperature is greater than 60° C., a time measurement (box 1312 ) is also performed. If this time value is less than 50% of the preset firing time, a PAUSE message (box 1313 ) is sent to microcontroller ( 112 ) and the laser is switched off (box 1314 ).
  • a time measurement (box 1315 ) is also performed. If this time value is less than 75% of the preset firing time, a further temperature measurement (box 1311 ) is performed. If, on the other hand, the time value is greater than 75% of the preset firing time TC, a STOP message (box 1316 ) is sent to microcontroller ( 112 ). A temperature measurement is then performed (box 1317 ), and if temperature is less than 60° C., the firing time is checked (box 1318 ). If the actual firing time is less than the preset firing time TC (meaning that the laser treatment has not yet finished), a further temperature check is performed (back to box 1317 ).
  • microcontroller ( 112 ) waits for a message (box 1402 ).
  • a message (box 1403 ) is received, said message is analysed. If the message is START, and the laser was last fired less than 5 seconds ago (box 1405 ), microcontroller ( 111 ) sends the WAIT message (box 1406 ).
  • the totaLstart variable is set to a predetermined maximum (box 1410 ) and the OK message is sent (box 1411 ).
  • the totaLstart variable (box 1414 ) is analysed. If this variable is lower than the specified maximum, the TREATED message is sent (box 1415 ). If not, the last_start variable (box 1416 ) is analysed. If this variable is greater than 60 minutes, the TREATED message is sent (box 1415 ). If not, a check is performed to see whether the laser was last fired more than 5 seconds ago (box 1417 ). If not, the WAIT message is sent (box 1418 ). If, on the other hand, the laser was last fired more than 5 seconds ago, the OK message is sent and the settings are read (box 1419 ).
  • the information in the RFID component could be selected from the following possibilities: unique RFID component identifier, manufacturing date, expiry date, device settings identifier based on skin type, safety strip manufacturing batch number.
  • the adhesive attachment element shall have a threefold safety role:
  • the means of preventing reuse of adhesive attachment element ( 90 ) could directly be included in the RFID component itself.
  • microcontrollers 111 and 112 control the laser power and firing time on the basis of data contained in the RFID tags in a strip chosen by the practitioner following a Fitzpatrick skin typing test to ascertain the patient's phototype.
  • the laser control settings can be used to ensure the fluence values are within a range determined by the skin phototype, as described above, in order to achieve a suitable wound healing effect, whilst avoiding any burning, in a safe environment, secured by the use of such strips.
  • the laser has a chromameter connected to microcontroller ( 111 ).
  • skin lightness is used as the basis for selecting the laser power and firing time, in order to ensure the fluence values are within a range determined by the lightness value, as described above.

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US20140188095A1 (en) * 2012-12-31 2014-07-03 Paul Joseph Weber Apparatus and systems for tissue dissection and modification
WO2014164254A1 (en) * 2013-03-12 2014-10-09 DePuy Synthes Products, LLC Laser type fixation member securement device and activation system, and related system
US9247981B2 (en) 2013-03-12 2016-02-02 DePuy Synthes Products, Inc. Laser type fixation member securement device and activation system, and related system and methods
EP3127501A1 (en) * 2015-08-07 2017-02-08 Advanced Osteotomy Tools - AOT AG Conditioning a laser-tissue contact surface
US20170165498A1 (en) * 2010-08-11 2017-06-15 Koninklijke Philips N.V. Phototherapy method and device
CN107678086A (zh) * 2017-08-31 2018-02-09 北京航天控制仪器研究所 一种实现高斯光束整形为一维平顶光束的光纤
US20190216542A1 (en) * 2018-01-16 2019-07-18 Bin Rao Methods and apparatus for optimizing selective photothermolysis
US20190336213A1 (en) * 2018-05-04 2019-11-07 Bin Rao High power tunable optical parametric oscillator for selective photothermolysis laser surgeries
US11510730B2 (en) 2016-03-26 2022-11-29 Paul Joseph Weber Apparatus and methods for minimally invasive dissection and modification of tissues
FR3126609A1 (fr) * 2021-09-08 2023-03-10 Urgo Recherche Innovation Et Developpement Coque pour dispositif de traitement dermatologique
US11771489B2 (en) 2016-03-26 2023-10-03 Paul J. Weber Apparatus and systems for minimally invasive dissection of tissues
US11890048B2 (en) 2016-03-26 2024-02-06 Paul J. Weber Apparatus and systems for minimally invasive dissection of tissues

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FR2954690A1 (fr) 2009-12-29 2011-07-01 Ekkyo Dispositif de traitement dermatologique par faisceau lumineux
FR3046546B1 (fr) 2016-01-07 2020-12-25 Urgo Rech Innovation Et Developpement Dispositif de traitement dermatologique
FR3046545B1 (fr) 2016-01-07 2021-05-28 Urgo Rech Innovation Et Developpement Dispositif de traitement dermatologique equipe d'un moyen de surveillance des ventilateurs
USD903113S1 (en) 2016-04-06 2020-11-24 Urgo Recherche Innovation Et Developpement Laser device
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WO2012011009A1 (en) * 2010-07-22 2012-01-26 Koninklijke Philips Electronics N.V. Improvements in phototherapy
US20170165498A1 (en) * 2010-08-11 2017-06-15 Koninklijke Philips N.V. Phototherapy method and device
US11045661B2 (en) * 2010-08-11 2021-06-29 Koninklijke Philips N.V. Phototherapy method and device
US20140188095A1 (en) * 2012-12-31 2014-07-03 Paul Joseph Weber Apparatus and systems for tissue dissection and modification
US10499970B2 (en) 2013-03-12 2019-12-10 DePuy Synthes Products, Inc. Laser type fixation member securement device and activation system, and related system and methods
WO2014164254A1 (en) * 2013-03-12 2014-10-09 DePuy Synthes Products, LLC Laser type fixation member securement device and activation system, and related system
CN105025985A (zh) * 2013-03-12 2015-11-04 德普伊新特斯产品公司 激光型固定构件稳固装置和启动系统及相关系统
US9247981B2 (en) 2013-03-12 2016-02-02 DePuy Synthes Products, Inc. Laser type fixation member securement device and activation system, and related system and methods
US9522027B2 (en) 2013-03-12 2016-12-20 DePuy Synthes Products, Inc. Laser type fixation member securement device and activation system, and related system and methods
US11510717B2 (en) 2013-03-12 2022-11-29 DePuy Synthes Products, Inc. Laser type fixation member securement device and activation system, and related system and methods
EP3127501A1 (en) * 2015-08-07 2017-02-08 Advanced Osteotomy Tools - AOT AG Conditioning a laser-tissue contact surface
EA034917B1 (ru) * 2015-08-07 2020-04-06 Эдванст Остеотоми Тулз - Эот Аг Кондиционирование поверхности контакта лазера и ткани
US11337758B2 (en) * 2015-08-07 2022-05-24 Advanced Osteotomy Tools—AOT AG Conditioning a laser-tissue contact surface
WO2017025335A1 (en) * 2015-08-07 2017-02-16 Advanced Osteotomy Tools - Aot Ag Conditioning a laser-tissue contact surface
US11771489B2 (en) 2016-03-26 2023-10-03 Paul J. Weber Apparatus and systems for minimally invasive dissection of tissues
US11890048B2 (en) 2016-03-26 2024-02-06 Paul J. Weber Apparatus and systems for minimally invasive dissection of tissues
US11510730B2 (en) 2016-03-26 2022-11-29 Paul Joseph Weber Apparatus and methods for minimally invasive dissection and modification of tissues
CN107678086A (zh) * 2017-08-31 2018-02-09 北京航天控制仪器研究所 一种实现高斯光束整形为一维平顶光束的光纤
US20190216542A1 (en) * 2018-01-16 2019-07-18 Bin Rao Methods and apparatus for optimizing selective photothermolysis
US10806513B2 (en) * 2018-01-16 2020-10-20 Bin Rao Methods and apparatus for optimizing selective photothermolysis
US10799292B2 (en) * 2018-05-04 2020-10-13 Bin Rao High power tunable optical parametric oscillator for selective photothermolysis laser surgeries
US20190336213A1 (en) * 2018-05-04 2019-11-07 Bin Rao High power tunable optical parametric oscillator for selective photothermolysis laser surgeries
WO2023036738A1 (fr) * 2021-09-08 2023-03-16 Urgo Recherche Innovation Et Developpement Coque pour dispositif de traitement dermatologique
FR3126609A1 (fr) * 2021-09-08 2023-03-10 Urgo Recherche Innovation Et Developpement Coque pour dispositif de traitement dermatologique

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PL2237731T3 (pl) 2018-02-28
WO2009071592A1 (fr) 2009-06-11
US20100305554A1 (en) 2010-12-02
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EP2237731B1 (fr) 2016-02-24
EP2237731A1 (fr) 2010-10-13

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