WO2016030707A1 - Device intended to be applied to the skin - Google Patents

Device intended to be applied to the skin Download PDF

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Publication number
WO2016030707A1
WO2016030707A1 PCT/IB2014/002502 IB2014002502W WO2016030707A1 WO 2016030707 A1 WO2016030707 A1 WO 2016030707A1 IB 2014002502 W IB2014002502 W IB 2014002502W WO 2016030707 A1 WO2016030707 A1 WO 2016030707A1
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WO
WIPO (PCT)
Prior art keywords
coldness
skin
generator
temperature
tip
Prior art date
Application number
PCT/IB2014/002502
Other languages
French (fr)
Inventor
Julien Steinbrunn
Sima Asvadi
Mart TE VELDE
Original Assignee
Laboratoires Urgo
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Laboratoires Urgo filed Critical Laboratoires Urgo
Priority to PCT/IB2014/002502 priority Critical patent/WO2016030707A1/en
Publication of WO2016030707A1 publication Critical patent/WO2016030707A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452Skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231Characteristics of handpieces or probes
    • A61B2018/0237Characteristics of handpieces or probes with a thermoelectric element in the probe for cooling purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001Body part
    • A61F2007/0052Body part for treatment of skin or hair
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • A61F2007/0075Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating using a Peltier element, e.g. near the spot to be heated or cooled
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0087Hand-held applicators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0093Heating or cooling appliances for medical or therapeutic treatment of the human body programmed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0095Heating or cooling appliances for medical or therapeutic treatment of the human body with a temperature indicator
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02Compresses or poultices for effecting heating or cooling
    • A61F2007/0244Compresses or poultices for effecting heating or cooling with layers
    • A61F2007/0246Compresses or poultices for effecting heating or cooling with layers with a layer having high heat transfer capability
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02Compresses or poultices for effecting heating or cooling
    • A61F2007/0244Compresses or poultices for effecting heating or cooling with layers
    • A61F2007/026Compresses or poultices for effecting heating or cooling with layers with a fluid absorbing layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02Compresses or poultices for effecting heating or cooling
    • A61F2007/0282Compresses or poultices for effecting heating or cooling for particular medical treatments or effects
    • A61F2007/0285Local anaesthetic effect

Definitions

  • the subject of the present invention is a device intended to be applied to the skin, comprising a coldness generator.
  • This device may notably be used for the cleaning of wounds.
  • Application WO2008/156353 proposes, for example, the use of a cryogenic probe for carrying out surgery inside the body but does not cover the use of coldness at the surface of the body for treating a wound.
  • Application US2010/0223935 covers a system for freezing a tissue sample so that it can be sliced. That application does not mention the use of coldness for treating a wound.
  • the natural healing of a wound takes place in three successive phases, each of these phases being characterized by specific cellular activity that causes the repair process to progress in three specific chronological sequences: the cleaning phase, the budding or granulation phase and the epithelialization phase.
  • the organism reacts by setting vascular and inflammatory phenomena to work in order to stop any risk of haemorrhaging and to protect the wound against the risks of infection.
  • the organism organizes in parallel the degradation of this fibrin matrix in order to make way for the extracellular matrix synthesized by the fibroblasts which are the key players in the budding phase. It is mainly this phase of eliminating the fibrin matrix and the various debris present in the wound that is referred to by the name of cleaning.
  • the cleaning phase is essential to the healing process. It being carried out and the speed at which it is carried out are key to the success and speed of the healing process.
  • the ability to perform natural cleaning may be insufficient when the trauma is great or when the patient is suffering from other complaints as well, such as venous pathologies or diabetes. In such cases it is thus found that the duration of the cleaning phase is lengthened considerably, leading to chronic wounds that are difficult to treat, such as leg ulcers for example.
  • necrotic and/or fibrinous tissue In the case of wounds for which the natural cleaning process is insufficient, such as chronic wounds, it is necessary to remove the necrotic and/or fibrinous tissue.
  • the removal of this necrotic and fibrinous tissue which may be performed using various techniques, is commonly known by the name of "assisted cleaning" as opposed to natural cleaning.
  • the assisted cleaning may be qualified as mechanical or surgical cleaning, enzymatic cleaning, autolytic cleaning or biological cleaning depending on the technique used.
  • Document WO 2007/025546 has proposed the use of a nonwoven of superabsorbent fibres, in which the fibres are needle-punched in such a way that they are spaced far enough apart that once they have become swollen they continue to allow exudate to pass through. By spacing the fibres apart, the cohesion of the nonwoven is reduced which means that it becomes necessary to prevent any fibres that might become detached from the nonwoven from contaminating the wound.
  • Application WO 2007/025544 thus provides for threads of a thermoplastic material to be applied by fiberization to the nonwoven to form loops, the intersections of which are fused. The basis weight of the threads needs to be lower than 100 g/m 2 in order to allow the exudate access to the absorbent layer.
  • Surgical or mechanical cleaning is a rapid technique which involves cutting away necrotic and/or fibrinous tissue either using a scalpel, tongs, scissors or a Brock curette, or using sophisticated apparatus involving pressurized water jets or laser excision. This technique is performed at the patient's bedside or in a surgical environment depending on the severity of the wound.
  • Hartmann Patent Application WO2011/073182 claims a dual-purpose dermatological curette, having two tools, one on each end of the curette, one for soft fibrin and the other for hard fibrin.
  • the proposed device can be applied, amongst other things, to making mechanical cleaning of wounds easier, without sticking to the wound, using a prior phase of freezing the fibrin. This improves the efficacy of the cleaning, reduces the trauma to the patient which is associated with the cleaning of the wound, and makes the task of the individual cleaning the wound easier.
  • This device is intended to be applied to the skin and comprises a coldness generator.
  • the coldness generator is designed to cool the skin to a temperature of between -30°C and 0°C for a duration, referred to in this description as the "coldness duration", of between 1 and 300 seconds.
  • skin refers to the skin, the wound, the mucous membranes and keratinous appendages.
  • the coldness generator cools the skin to a temperature of between -20°C and -5°C for a duration of between 5 and 60 seconds.
  • the coldness generator cools the skin to a temperature of between -15°C and -10°C, for a duration of between 10 seconds and 20 seconds.
  • the device comprises a coldness generator for cooling the skin in the region of the wound to a temperature of -15°C for a duration of 10 seconds.
  • said device comprises a coldness- conducting tip.
  • This tip has a thermal conductivity capable of transferring heat energy between the skin and the coldness generator.
  • the coldness-conducting tip may be made from a metal chosen from copper, silver, gold, aluminium, zinc, nickel, iron, palladium, platinum, tin and lead, or from an alloy based on one of these metals.
  • the coldness-conducting tip is made of copper.
  • the tip of the device is removable.
  • Said tip may be interchangeable so that it is specific to the application and avoids cross- contamination from one patient to another.
  • the device may comprise a material that can be applied to the skin and that covers the coldness-conducting tip.
  • Said material that can be applied to the skin may be chosen from nonadherent compresses, absorbent dressings, dressings containing a hydrocolloid mass and superabsorbent fibres.
  • non-adherent compress is intended to denote a sterile non-adherent compress of the type comprising a flexible open-cell fabric, said fabric comprising filaments which are coated with a cohesive and non-adherent gel so as to leave the mesh cells essentially unplugged.
  • the gel may be formed of a highly plasticized hydrophobic elastomeric matrix containing a dispersion of hydrophilic particles of a hydrocolloid.
  • the material of which the fabric is made may be a synthetic fibre with continuous filaments and, more preferably, a polyester filament.
  • the hydrophobic matrix may be based on a tri-block elastomer of the S-EB-S type with a high molecular weight and the elastomer may be plasticized from a mixture of paraffin oil and Vaseline in a proportion of at least 65% by weight of the gel.
  • the hydrocolloid in dispersion in the gel may be a sodium salt of carboxymethyl cellulose.
  • the non-adherent compress may contain enzymes that encourage the cleaning of the wound.
  • an "absorbent dressing” is intended to denote a dressing containing an absorbent foam and a backing that is impervious to fluids but permeable to water vapour.
  • the backing may be made up of an assembly of a continuous film and of a perforated reinforcement coated with an adhesive silicone gel, said reinforcement covering the entirety of the surface of the film on at least one of the sides thereof.
  • the dressing may comprise a non-absorbent web interposed between said absorbent foam and said backing, which web is bonded to the silicone-coated surface of said backing and fixed to the absorbent foam, preferably around the periphery thereof only.
  • a "dressing containing a hydrocolloid mass” is intended to mean a dressing comprising an adhesive hydrocolloid mass comprising a hydrophobic elastomeric matrix containing poly(styrene-olefin-styrene) block copolymers, hydrocolloid particles dispersed in said eiastomeric matrix and a tackifying hydrocarbon resin.
  • Superabsorbent fibres is intended to denote fibres which have a very high ability to absorb liquids, preferably greater than or equal to 10 grams (g) of water (or saline solution such as physiological saline solution) per gram of fibres, more preferably still more than 20 g of water per gram, and even more preferably still more than 30 g of water per gram.
  • the superabsorbent fibres may be made up of two different materials. These materials may be distributed in a side-by-side layout, or in a core-bark configuration.
  • the first material that forms the external part of the fibre preferably the bark
  • the first material that forms the external part of the fibre needs to be able to form a gel with the exudate from the wound and will advantageously be formed of one or more crosslinked and/or partially crosslinked polymers, such as, in particular, polymers of acrylic acid and/or polymers of salts of acrylic acid, notably sodium or ammonium acrylate.
  • the second material that forms the core of the superabsorbent fibres preferably cannot form a gel and is compatible with the first material in order to ensure the stability of the fibre after the first material has formed a gel. It may be formed of any type of polymer that is stable in an aqueous environment and compatible with the material of the bark in order to lead to a stable two-component fibre.
  • this second material is formed of polyacrylonitrile.
  • the superabsorbent fibres advantageously have a linear mass (or titre) of between 2 and 6 decitex (dtex).
  • Superabsorbent fibres that can be used in the proposed device are, for example, marketed by the company TOYOBO CO LTD under the trade name LANSEAL® F.
  • the device comprises a control element for controlling the duration of the coldness and a control system for controlling the set temperature.
  • the device comprises a timer by way of an element for controlling the coldness duration, and a microcontroller associated with a temperature sensor by way of an element for controlling the temperature.
  • thermocouples or thermoelectric couples (TECs) are pairs of materials in which the Seebeck effect is used for measuring temperature.
  • the device comprises a system for automatically controlling the temperature to which the skin is cooled.
  • This description also relates to a method for adjusting the parameters of use of a device according to any one of the abovementioned embodiments, comprising the steps of programming a temperature and an optimum cooling duration.
  • the coldness generator can be chosen from a cooled element, a Peltier effect module, a refrigeration compressor and a Stirling-type engine.
  • the cooled element may be an instant cold pack, such as those used in sport (for example, the product marketed under the trade name Articare® Cold Pack, single use), that has to be compressed very firmly between the hands for a chemical reaction to take place and release coldness instantaneously.
  • This pack is applied directly to the skin and may be held in position by a cohesive strip (Tensoplus® or Coplus®).
  • the Peltier module may be made up of one or more Peltier elements and may be coupled thermally to heat sinks.
  • the Peltier-effect module allows a temperature to be varied in a very simple way, through the control of an electrical current, with the possibility of lowering this temperature.
  • Such a module is for example marketed by the CONRAD company under the Peltier element 3504 trade name.
  • Peltier elements are highly reliable, require very little maintenance and are durable because of the lack of moving parts subject to wear. In addition, they operate noiselessly and without vibration. They can be small and lightweight even when a number of modules have been combined within one single system. Another advantage is the low cost of manufacture thereof. Peltier systems contain no flammable refrigerants, harmful to the ozone layer and do not contribute to the greenhouse effect. Peltier elements can be replaced quickly and easily in the event of failure. Recent control technologies provide better control over cooling than conventional compressors. It is also possible to reverse the function of a system by reversing the polarity, i.e., a cooling element may become an effective heating element.
  • the refrigeration compressor is a component of a thermodynamic machine, such as those used in refrigerators or freezers.
  • the compressor drives the thermal fluid through a circuit. It therefore has a role of compressing the cold air and making this cold air circulate through a circuit in order to provide uniform cooling within the apparatus.
  • the refrigeration compressor is chosen from a piston compressor, a spiro-orbital or scroll compressor, a rotary compressor, a screw compressor or a turbocompressor or a centrifugal compressor.
  • a Stirling engine is an engine with an external source of energy.
  • the main fluid is a gas subjected to a cycle comprising four phases: isochoric heating, at constant volume, isothermal expansion, at constant temperature, isochoric cooling followed by isothermal compression.
  • a Stirling-type engine produces little vibration and there is no escaping gas. That makes it quiet and reduces mechanical stresses. Maintenance is easy because this type of engine experiences less deterioration than an internal combustion engine. It can operate on any source of heat (combustion of any fuel, solar, nuclear, or human bodily warmth).
  • the device as described hereinabove allows the targeted application of the coldness to those parts of the skin that are to be removed at a dose the area of application of which is controlled for rapid change of state of the skin without any effect on healthy underlying tissue.
  • this device does not adhere to the skin.
  • the present invention by proposing a system that is lightweight and portable, makes the work of the care personnel easier by allowing an action that is well tolerated and can be performed with confidence, allowing easier removal and good pick-up, with the device as described being simple to operate.
  • the device allows the relevant tissue to be removed in a nontraumatic way, without bleeding or pain to the patient, thanks to the analgesic effect of the coldness.
  • another object of the invention is also the use of the device as described for the purposes of cryotherapy, cryosurgery, wound treatment, heaiing treatment, postoperative treatment, local pain treatment, an aesthetic application, a dermo-cosmetic application and/or for muscle recovery.
  • the invention as described makes cleaning of a wound easier, in a healthy environment rid of bacteria.
  • Figure 1 illustrates a general arrangement of the device.
  • Figure 2 depicts the end intended to be applied to the skin, of the device of figure 1.
  • Figure 3 very schematically depicts the tip of the device of figure 1.
  • Figure 4 depicts another example of tip.
  • the device 100 of FIGS 1 to 3 can be applied to the skin to facilitate the cleaning of a wound 102 comprising fibrinous tissue 103. More specifically, the device 100 has an end 101 which bears a tip 112, and it is this tip 112 that is applied to the wound 102.
  • the device 100 comprises a coldness generator 113 for cooling the skin in the region of the wound 102 to a temperature of between -30°C and 0°C for a duration of between 1 and 300 seconds.
  • the coldness generator 113 cools the skin to a temperature preferably of between -20°C and -5°C, and more preferably of between -15°C and -10°C for a duration preferably of between 5 and 60 seconds and more preferably of 10 to 20 seconds.
  • the device 100 comprises a coldness generator 113 for cooling the skin in the region of the wound 102 to a temperature of -15°C for a duration of 10 seconds.
  • the coldness-conducting tip 112 is covered with superabsorbent fibres (which have not been depicted).
  • the coldness- conducting tip 112 covered with superabsorbent fibres does not adhere to the skin.
  • the coldness-conducting tip 112 is chosen from copper, silver, gold, aluminium, zinc, nickel, iron, palladium, platinum, tin and lead.
  • Tip 112 may be removable. Thus, there is a possibility of changing it for another tip, depending on the injury to be treated.
  • the coldness generator 113 is controlled by a temperature control system 109.
  • the device 100 may also comprise an element that controls the duration of coldness, so as to control the duration of cooling or duration of coldness of the skin.
  • the coldness duration is preferably comprised between 5 and 60 seconds, and more preferably between 10 seconds and 20 seconds.
  • the control element that controls the coldness duration may be a timer.
  • the control element may also comprise an alarm, particularly a visible or audible alarm, associated with the timer.
  • This control element (not depicted) may be incorporated into the end 101 or into the temperature control system 109.
  • the temperature control system 109 provides control over the coldness generator 113 and therefore makes it possible to control the production of coldness.
  • the control system 109 is electrically connected to the coldness generator 113 by means of a cable 117.
  • the temperature control system 109 comprises a microcontroller coupled, on the one hand, to the coldness generator 113 in order to increase, maintain or decrease the production of coldness and, on the other hand, to a temperature sensor able to measure the temperature attained at the tip 112 and, therefore, at skin level when the tip 112 is applied to this skin.
  • the device also comprises a power supply source powering the coldness generator 113.
  • This power supply source (not depicted) can be incorporated into the end 101 or into the temperature control system 109. In the latter case, the power supply source powers the coldness generator 113 via the cable 117.
  • the chosen ranges of temperatures and application periods are optimal for achieving a physico-chemical change in the relevant tissue that alters the properties thereof.
  • these controls are automatic, they allow the device 100 to be used in a simple way.
  • the coldness generator 113 may be a Peltier-effect module. Such a module has a first face 113a for absorbing heat and a second face 113b for releasing heat.
  • the first face 113a is covered by the tip 112 that has sufficient thermal conductivity to absorb the thermal energy from the skin in order to cool same.
  • the heat sink 114 On the second face 113b of the coldness generator 113 there is a heat sink 114 that allows the heat released by the coldness generator 113 to be removed.
  • the heat sink 114 may, for example, be made up of a set of fins or of a fan.
  • the device 100 may also comprise a switch 108 for switching the coldness generator 113 on or off, and an indicator (e.g. a screen) 116 informing of the temperature of the tip 112.
  • a switch 108 for switching the coldness generator 113 on or off
  • an indicator e.g. a screen
  • the tip 112, the coldness generator 113, the heat sink 114 and the temperature control system 109 are all incorporated into the end 101.
  • the tip 112 is situated on the front face 101a of the end 101.
  • the coldness generator 113 may be a Peltier-effect module.
  • the coldness generator 113 is connected to the temperature control system 109.
  • the control system 109 may comprise a microcontroller and adjusting knobs 119 connected to the microcontroller.
  • a fan 115 may be placed in the end 101, behind the heat sink 114 (i.e. on the opposite side of the coldness generator 113) to improve the removal of heat.
  • a temperature indicator 116, an alarm 121 and a switch 108 may be provided, for example on the rear face 101b or on a lateral face of the tip 101.
  • the system in its entirety may be powered with energy by being connected to a power supply source 125 (e.g. an accumulator battery) via an electric lead 127.
  • This power supply source 125 may equally be incorporated into the end 101.
  • the entirety of the system may be connected to the electric mains via an electric lead, an adapter and an electrical outlet.
  • the coldness generator 113 may be a cooled element, such as a block of ice, or a compressor, such as those used in refrigerators, or a Stirling-type engine.
  • Use of the device may involve spreading a conductive paste over the interface between the coldness generator 113 and the tip 112, this tip 112 being held in contact with the refrigerating element 113 removably, for example by means of a clip.
  • thermocouple 100 When the tip 112 is changed, the thermocouple 100 is associated with said tip 112 as depicted in figure 3. A temperature set point is then given to the control system 109 and a check is run to ensure that the temperature recorded by the thermocouple 100 corresponds to this temperature set point.
  • the tip 112 is then brought into contact with the surface of the skin for a variable contact time (or coldness duration) at the end of which the tip 112 is withdrawn.
  • the objective is to demonstrate the impact that the cold generated by a coldness generator has on one of the applications of said device, namely cleaning.
  • the impact that cold has on in-vitro reconstituted fibrin has been observed and the optimum operating conditions for freezing the fibrin so that it thereafter becomes easier for care personnel to handle using cleaning tools, for example curettes, has been defined.
  • the device used comprises a coldness generator and a tip made of copper, which is a conductor of coldness.
  • the coldness generator comprises a conventional refrigeration compressor cooling a bath made up of a liquid mixture of water and glycol (the glycol lowers the freezing temperature of the bath, i.e. the freezing point of the mixture varies as a function of the volume percentage of glycol).
  • a hydraulic circuit allows the cooled liquid to be circulated between the bath and the coldness-conducting tip and thus allows the tip to be kept at the temperature of the bath. This temperature is controlled by a temperature control system that operates the refrigeration compressor.
  • a thermocouple is mounted on the tip and a temperature indicator is associated with the thermocouple.
  • test specimen of in-vitro reconstituted fibrin is brought into contact with the copper tip in order to cool the fibrin.
  • the tests are carried out at various temperatures with a variable contact time and with a variation in contact intensity (test specimen barely kissing the cold head (+/-)/cold head pressing lightly against the test specimen (+)/cold head pressing firmly against the test specimen (++)).
  • a set maximum contact time of 30 seconds was chosen in order to facilitate the job of the care personnel when using said device.
  • the temperature and the contact intensity remain parameters that can be varied.
  • the experiment was conducted at different initial temperatures (TO), namely -17°C, -15°C, -10°C and -5°C. The highest temperature over the 30 seconds and the temperature at 30 seconds (at the end of cooling) were recorded.
  • TO initial temperatures
  • the fibrin readopts a more viscous and stringy gel appearance closely resembling that of its initial state.

Abstract

Device intended to be applied to the skin, comprising a coldness generator (113). The coldness generator (113) cools the skin to a temperature of between -30°C and 0°C for a coldness duration of between 1 and 300 seconds. The device comprises a coldness-conducting tip (112) able to transfer heat energy between the skin and the coldness generator.

Description

DEVICE INTENDED TO BE APPLIED TO THE SKIN
TECHNICAL FIELD
The subject of the present invention is a device intended to be applied to the skin, comprising a coldness generator. This device may notably be used for the cleaning of wounds.
BACKGROUND
The use of coldness and, more particularly, of very low temperatures, for destroying living tissue and removing it from the organism is known. Application WO2008/156353 proposes, for example, the use of a cryogenic probe for carrying out surgery inside the body but does not cover the use of coldness at the surface of the body for treating a wound. Application US2010/0223935, on the other hand, covers a system for freezing a tissue sample so that it can be sliced. That application does not mention the use of coldness for treating a wound.
The natural healing of a wound takes place in three successive phases, each of these phases being characterized by specific cellular activity that causes the repair process to progress in three specific chronological sequences: the cleaning phase, the budding or granulation phase and the epithelialization phase.
Immediately following a trauma, the organism reacts by setting vascular and inflammatory phenomena to work in order to stop any risk of haemorrhaging and to protect the wound against the risks of infection.
These phenomena lead to the formation of a fibrin-based matrix which will contribute to stopping the bleeding. This matrix also provides a temporary and unrefined closure of the wound.
In order to begin the next step of budding, the organism organizes in parallel the degradation of this fibrin matrix in order to make way for the extracellular matrix synthesized by the fibroblasts which are the key players in the budding phase. It is mainly this phase of eliminating the fibrin matrix and the various debris present in the wound that is referred to by the name of cleaning.
The cleaning phase is essential to the healing process. It being carried out and the speed at which it is carried out are key to the success and speed of the healing process. However, the ability to perform natural cleaning may be insufficient when the trauma is great or when the patient is suffering from other complaints as well, such as venous pathologies or diabetes. In such cases it is thus found that the duration of the cleaning phase is lengthened considerably, leading to chronic wounds that are difficult to treat, such as leg ulcers for example.
In the case of wounds for which the natural cleaning process is insufficient, such as chronic wounds, it is necessary to remove the necrotic and/or fibrinous tissue. The removal of this necrotic and fibrinous tissue, which may be performed using various techniques, is commonly known by the name of "assisted cleaning" as opposed to natural cleaning.
The assisted cleaning may be qualified as mechanical or surgical cleaning, enzymatic cleaning, autolytic cleaning or biological cleaning depending on the technique used.
However, none of the cleaning techniques current employed is optimal, and all these techniques have disadvantages.
Document WO 2007/025546 has proposed the use of a nonwoven of superabsorbent fibres, in which the fibres are needle-punched in such a way that they are spaced far enough apart that once they have become swollen they continue to allow exudate to pass through. By spacing the fibres apart, the cohesion of the nonwoven is reduced which means that it becomes necessary to prevent any fibres that might become detached from the nonwoven from contaminating the wound. Application WO 2007/025544 thus provides for threads of a thermoplastic material to be applied by fiberization to the nonwoven to form loops, the intersections of which are fused. The basis weight of the threads needs to be lower than 100 g/m2 in order to allow the exudate access to the absorbent layer.
Nevertheless, all of these dressings are far from allowing optimal cleaning. Use thereof is often combined with mechanical cleaning which means that the patient has to go through procedures which are painful and traumatic.
Surgical or mechanical cleaning is a rapid technique which involves cutting away necrotic and/or fibrinous tissue either using a scalpel, tongs, scissors or a Brock curette, or using sophisticated apparatus involving pressurized water jets or laser excision. This technique is performed at the patient's bedside or in a surgical environment depending on the severity of the wound. Hartmann Patent Application WO2011/073182 claims a dual-purpose dermatological curette, having two tools, one on each end of the curette, one for soft fibrin and the other for hard fibrin.
However, this technique is often painful and may lead to bleeding and sometimes to haemorrhaging. It is therefore traumatic for the patient. It also commonly requires analgesic medication to be taken beforehand, lengthening the care time.
There is therefore a need for a device that:
- makes it possible to avoid resorting to techniques which are traumatic from a physical or psychological standpoint, such as conventional mechanical cleaning or asticotherapy, and/or
- allows the pain to be reduced locally thus making the cleaning non traumatic.
GENERAL PRESENTATION
The proposed device can be applied, amongst other things, to making mechanical cleaning of wounds easier, without sticking to the wound, using a prior phase of freezing the fibrin. This improves the efficacy of the cleaning, reduces the trauma to the patient which is associated with the cleaning of the wound, and makes the task of the individual cleaning the wound easier.
This device is intended to be applied to the skin and comprises a coldness generator. The coldness generator is designed to cool the skin to a temperature of between -30°C and 0°C for a duration, referred to in this description as the "coldness duration", of between 1 and 300 seconds.
Within the meaning of the present invention, the term "skin" refers to the skin, the wound, the mucous membranes and keratinous appendages.
According to one embodiment, the coldness generator cools the skin to a temperature of between -20°C and -5°C for a duration of between 5 and 60 seconds.
Advantageously, the coldness generator cools the skin to a temperature of between -15°C and -10°C, for a duration of between 10 seconds and 20 seconds. For example, the device comprises a coldness generator for cooling the skin in the region of the wound to a temperature of -15°C for a duration of 10 seconds.
According to one embodiment, said device comprises a coldness- conducting tip. This tip has a thermal conductivity capable of transferring heat energy between the skin and the coldness generator. In particular, the coldness-conducting tip may be made from a metal chosen from copper, silver, gold, aluminium, zinc, nickel, iron, palladium, platinum, tin and lead, or from an alloy based on one of these metals. According to one preferred embodiment, the coldness-conducting tip is made of copper.
For preference, the tip of the device is removable. Said tip may be interchangeable so that it is specific to the application and avoids cross- contamination from one patient to another.
The device may comprise a material that can be applied to the skin and that covers the coldness-conducting tip.
Said material that can be applied to the skin may be chosen from nonadherent compresses, absorbent dressings, dressings containing a hydrocolloid mass and superabsorbent fibres.
A "non-adherent compress" is intended to denote a sterile non-adherent compress of the type comprising a flexible open-cell fabric, said fabric comprising filaments which are coated with a cohesive and non-adherent gel so as to leave the mesh cells essentially unplugged. The gel may be formed of a highly plasticized hydrophobic elastomeric matrix containing a dispersion of hydrophilic particles of a hydrocolloid. The material of which the fabric is made may be a synthetic fibre with continuous filaments and, more preferably, a polyester filament. The hydrophobic matrix may be based on a tri-block elastomer of the S-EB-S type with a high molecular weight and the elastomer may be plasticized from a mixture of paraffin oil and Vaseline in a proportion of at least 65% by weight of the gel. The hydrocolloid in dispersion in the gel may be a sodium salt of carboxymethyl cellulose.
The non-adherent compress may contain enzymes that encourage the cleaning of the wound.
An "absorbent dressing" is intended to denote a dressing containing an absorbent foam and a backing that is impervious to fluids but permeable to water vapour. The backing may be made up of an assembly of a continuous film and of a perforated reinforcement coated with an adhesive silicone gel, said reinforcement covering the entirety of the surface of the film on at least one of the sides thereof. The dressing may comprise a non-absorbent web interposed between said absorbent foam and said backing, which web is bonded to the silicone-coated surface of said backing and fixed to the absorbent foam, preferably around the periphery thereof only.
A "dressing containing a hydrocolloid mass" is intended to mean a dressing comprising an adhesive hydrocolloid mass comprising a hydrophobic elastomeric matrix containing poly(styrene-olefin-styrene) block copolymers, hydrocolloid particles dispersed in said eiastomeric matrix and a tackifying hydrocarbon resin.
"Superabsorbent fibres" is intended to denote fibres which have a very high ability to absorb liquids, preferably greater than or equal to 10 grams (g) of water (or saline solution such as physiological saline solution) per gram of fibres, more preferably still more than 20 g of water per gram, and even more preferably still more than 30 g of water per gram.
The superabsorbent fibres may be made up of two different materials. These materials may be distributed in a side-by-side layout, or in a core-bark configuration.
If they are in a core-bark configuration, the first material that forms the external part of the fibre, preferably the bark, needs to be able to form a gel with the exudate from the wound and will advantageously be formed of one or more crosslinked and/or partially crosslinked polymers, such as, in particular, polymers of acrylic acid and/or polymers of salts of acrylic acid, notably sodium or ammonium acrylate. The second material that forms the core of the superabsorbent fibres preferably cannot form a gel and is compatible with the first material in order to ensure the stability of the fibre after the first material has formed a gel. It may be formed of any type of polymer that is stable in an aqueous environment and compatible with the material of the bark in order to lead to a stable two-component fibre. Advantageously, this second material is formed of polyacrylonitrile.
The superabsorbent fibres advantageously have a linear mass (or titre) of between 2 and 6 decitex (dtex).
Superabsorbent fibres that can be used in the proposed device are, for example, marketed by the company TOYOBO CO LTD under the trade name LANSEAL® F.
The use of the superabsorbent fibres which cover the coldness-conducting tip allows the device not to stick to the skin. According to one embodiment, the device comprises a control element for controlling the duration of the coldness and a control system for controlling the set temperature. For preference, the device comprises a timer by way of an element for controlling the coldness duration, and a microcontroller associated with a temperature sensor by way of an element for controlling the temperature.
Said temperature sensor may comprise a thermocouple. In physics, thermocouples or thermoelectric couples (TECs) are pairs of materials in which the Seebeck effect is used for measuring temperature.
In one embodiment, the device comprises a system for automatically controlling the temperature to which the skin is cooled.
This description also relates to a method for adjusting the parameters of use of a device according to any one of the abovementioned embodiments, comprising the steps of programming a temperature and an optimum cooling duration.
The coldness generator can be chosen from a cooled element, a Peltier effect module, a refrigeration compressor and a Stirling-type engine.
Within the meaning of this description, the cooled element may be an instant cold pack, such as those used in sport (for example, the product marketed under the trade name Articare® Cold Pack, single use), that has to be compressed very firmly between the hands for a chemical reaction to take place and release coldness instantaneously. This pack is applied directly to the skin and may be held in position by a cohesive strip (Tensoplus® or Coplus®).
Within the meaning of the present description, the Peltier module may be made up of one or more Peltier elements and may be coupled thermally to heat sinks. The Peltier-effect module allows a temperature to be varied in a very simple way, through the control of an electrical current, with the possibility of lowering this temperature. Such a module is for example marketed by the CONRAD company under the Peltier element 3504 trade name.
Peltier elements are highly reliable, require very little maintenance and are durable because of the lack of moving parts subject to wear. In addition, they operate noiselessly and without vibration. They can be small and lightweight even when a number of modules have been combined within one single system. Another advantage is the low cost of manufacture thereof. Peltier systems contain no flammable refrigerants, harmful to the ozone layer and do not contribute to the greenhouse effect. Peltier elements can be replaced quickly and easily in the event of failure. Recent control technologies provide better control over cooling than conventional compressors. It is also possible to reverse the function of a system by reversing the polarity, i.e., a cooling element may become an effective heating element.
Within the meaning of the present description, the refrigeration compressor is a component of a thermodynamic machine, such as those used in refrigerators or freezers. In a refrigerating appliance, the compressor drives the thermal fluid through a circuit. It therefore has a role of compressing the cold air and making this cold air circulate through a circuit in order to provide uniform cooling within the apparatus.
According to one embodiment, the refrigeration compressor is chosen from a piston compressor, a spiro-orbital or scroll compressor, a rotary compressor, a screw compressor or a turbocompressor or a centrifugal compressor.
Within the meaning of the present description, a Stirling engine is an engine with an external source of energy. The main fluid is a gas subjected to a cycle comprising four phases: isochoric heating, at constant volume, isothermal expansion, at constant temperature, isochoric cooling followed by isothermal compression.
A Stirling-type engine produces little vibration and there is no escaping gas. That makes it quiet and reduces mechanical stresses. Maintenance is easy because this type of engine experiences less deterioration than an internal combustion engine. It can operate on any source of heat (combustion of any fuel, solar, nuclear, or human bodily warmth).
The device as described hereinabove allows the targeted application of the coldness to those parts of the skin that are to be removed at a dose the area of application of which is controlled for rapid change of state of the skin without any effect on healthy underlying tissue. In addition, advantageously, this device does not adhere to the skin.
The present invention, by proposing a system that is lightweight and portable, makes the work of the care personnel easier by allowing an action that is well tolerated and can be performed with confidence, allowing easier removal and good pick-up, with the device as described being simple to operate. In addition, the device allows the relevant tissue to be removed in a nontraumatic way, without bleeding or pain to the patient, thanks to the analgesic effect of the coldness.
Aside from being used for the cleaning of a wound at skin level, another object of the invention is also the use of the device as described for the purposes of cryotherapy, cryosurgery, wound treatment, heaiing treatment, postoperative treatment, local pain treatment, an aesthetic application, a dermo-cosmetic application and/or for muscle recovery.
It may also be emphasised that cold has an effect on the cell growth of bacteria. Specifically, freezing halts bacterial growth and kills certain bacteria. Thus, the invention as described makes cleaning of a wound easier, in a healthy environment rid of bacteria.
BRIEF DESCRIPTION OF THE DRAWINGS
The appended drawings are schematic and not to scale; they seek first and foremost to illustrate the principles of the invention.
Figure 1 illustrates a general arrangement of the device.
Figure 2 depicts the end intended to be applied to the skin, of the device of figure 1.
Figure 3 very schematically depicts the tip of the device of figure 1.
Figure 4 depicts another example of tip.
DETAILED DESCRIPTION
Exemplary embodiments are described in detail hereinafter with reference to the attached drawings. These embodiments illustrate the features and advantages of the invention. However, it must be recalled that the invention is not restricted to these exemplary embodiments.
The device 100 of FIGS 1 to 3 can be applied to the skin to facilitate the cleaning of a wound 102 comprising fibrinous tissue 103. More specifically, the device 100 has an end 101 which bears a tip 112, and it is this tip 112 that is applied to the wound 102.
The device 100 comprises a coldness generator 113 for cooling the skin in the region of the wound 102 to a temperature of between -30°C and 0°C for a duration of between 1 and 300 seconds. Advantageously, the coldness generator 113 cools the skin to a temperature preferably of between -20°C and -5°C, and more preferably of between -15°C and -10°C for a duration preferably of between 5 and 60 seconds and more preferably of 10 to 20 seconds.
For example, the device 100 comprises a coldness generator 113 for cooling the skin in the region of the wound 102 to a temperature of -15°C for a duration of 10 seconds.
For preference, the coldness-conducting tip 112 is covered with superabsorbent fibres (which have not been depicted). The coldness- conducting tip 112 covered with superabsorbent fibres does not adhere to the skin.
Advantageously, the coldness-conducting tip 112 is chosen from copper, silver, gold, aluminium, zinc, nickel, iron, palladium, platinum, tin and lead.
Tip 112 may be removable. Thus, there is a possibility of changing it for another tip, depending on the injury to be treated.
The coldness generator 113 is controlled by a temperature control system 109.
The device 100 may also comprise an element that controls the duration of coldness, so as to control the duration of cooling or duration of coldness of the skin. The coldness duration is preferably comprised between 5 and 60 seconds, and more preferably between 10 seconds and 20 seconds.
The control element that controls the coldness duration may be a timer.
The control element may also comprise an alarm, particularly a visible or audible alarm, associated with the timer. This control element (not depicted) may be incorporated into the end 101 or into the temperature control system 109.
The temperature control system 109 provides control over the coldness generator 113 and therefore makes it possible to control the production of coldness. The control system 109 is electrically connected to the coldness generator 113 by means of a cable 117. For example, the temperature control system 109 comprises a microcontroller coupled, on the one hand, to the coldness generator 113 in order to increase, maintain or decrease the production of coldness and, on the other hand, to a temperature sensor able to measure the temperature attained at the tip 112 and, therefore, at skin level when the tip 112 is applied to this skin.
The device also comprises a power supply source powering the coldness generator 113. This power supply source (not depicted) can be incorporated into the end 101 or into the temperature control system 109. In the latter case, the power supply source powers the coldness generator 113 via the cable 117.
The chosen ranges of temperatures and application periods are optimal for achieving a physico-chemical change in the relevant tissue that alters the properties thereof. As these controls are automatic, they allow the device 100 to be used in a simple way.
The coldness generator 113 may be a Peltier-effect module. Such a module has a first face 113a for absorbing heat and a second face 113b for releasing heat.
The first face 113a is covered by the tip 112 that has sufficient thermal conductivity to absorb the thermal energy from the skin in order to cool same.
On the second face 113b of the coldness generator 113 there is a heat sink 114 that allows the heat released by the coldness generator 113 to be removed. The heat sink 114 may, for example, be made up of a set of fins or of a fan.
The device 100 may also comprise a switch 108 for switching the coldness generator 113 on or off, and an indicator (e.g. a screen) 116 informing of the temperature of the tip 112.
In another exemplary embodiment depicted in FIG 4, the tip 112, the coldness generator 113, the heat sink 114 and the temperature control system 109 are all incorporated into the end 101. The tip 112 is situated on the front face 101a of the end 101. The coldness generator 113 may be a Peltier-effect module. The coldness generator 113 is connected to the temperature control system 109. The control system 109 may comprise a microcontroller and adjusting knobs 119 connected to the microcontroller. A fan 115 may be placed in the end 101, behind the heat sink 114 (i.e. on the opposite side of the coldness generator 113) to improve the removal of heat. A temperature indicator 116, an alarm 121 and a switch 108 may be provided, for example on the rear face 101b or on a lateral face of the tip 101. The system in its entirety may be powered with energy by being connected to a power supply source 125 (e.g. an accumulator battery) via an electric lead 127. This power supply source 125 may equally be incorporated into the end 101. As an alternative, the entirety of the system may be connected to the electric mains via an electric lead, an adapter and an electrical outlet. In another exemplary embodiment (which has not been depicted), the coldness generator 113 may be a cooled element, such as a block of ice, or a compressor, such as those used in refrigerators, or a Stirling-type engine.
Use of the device may involve spreading a conductive paste over the interface between the coldness generator 113 and the tip 112, this tip 112 being held in contact with the refrigerating element 113 removably, for example by means of a clip.
When the tip 112 is changed, the thermocouple 100 is associated with said tip 112 as depicted in figure 3. A temperature set point is then given to the control system 109 and a check is run to ensure that the temperature recorded by the thermocouple 100 corresponds to this temperature set point.
In this embodiment, the tip 112 is then brought into contact with the surface of the skin for a variable contact time (or coldness duration) at the end of which the tip 112 is withdrawn.
Example 1:
The objective is to demonstrate the impact that the cold generated by a coldness generator has on one of the applications of said device, namely cleaning. The impact that cold has on in-vitro reconstituted fibrin has been observed and the optimum operating conditions for freezing the fibrin so that it thereafter becomes easier for care personnel to handle using cleaning tools, for example curettes, has been defined.
The device used comprises a coldness generator and a tip made of copper, which is a conductor of coldness. The coldness generator comprises a conventional refrigeration compressor cooling a bath made up of a liquid mixture of water and glycol (the glycol lowers the freezing temperature of the bath, i.e. the freezing point of the mixture varies as a function of the volume percentage of glycol). A hydraulic circuit allows the cooled liquid to be circulated between the bath and the coldness-conducting tip and thus allows the tip to be kept at the temperature of the bath. This temperature is controlled by a temperature control system that operates the refrigeration compressor. A thermocouple is mounted on the tip and a temperature indicator is associated with the thermocouple.
The test specimen of in-vitro reconstituted fibrin is brought into contact with the copper tip in order to cool the fibrin. The tests are carried out at various temperatures with a variable contact time and with a variation in contact intensity (test specimen barely kissing the cold head (+/-)/cold head pressing lightly against the test specimen (+)/cold head pressing firmly against the test specimen (++)).
A set maximum contact time of 30 seconds was chosen in order to facilitate the job of the care personnel when using said device. The temperature and the contact intensity remain parameters that can be varied.
The experiment was conducted at different initial temperatures (TO), namely -17°C, -15°C, -10°C and -5°C. The highest temperature over the 30 seconds and the temperature at 30 seconds (at the end of cooling) were recorded.
The following observations were made:
- Frozen appearance of the fibrin: hardness, texture, percentage freezing of the test specimen.
- Handling of the fibrin: determination of the consistency of the test specimen and evaluation of how easy it is to scoop up with a curette.
The following waiting times were noted:
- Time required before the test specimen is debrided: there was an attempt to evaluate the time required for the test specimen to become easy to handle using a curette.
- Time needed until the test specimen returned to its initial state (i.e. the state it occupied prior to cooling).
The results obtained are set out in table 1 below. In the table, the times given are in seconds (s).
TABLE 1
Contact + + + +Λ
Temperature at the thermocouple (°C):
Initial temperature TO -17 -17 -17
Highest temperature Tmax -9.7 -9.7 -12.6
Temperature at 30 s (withdrawal of the appliance) -11.4 -13 -13
Temperature delta (|Tmax - T0|) 7.3 4.8 4.4
Time waiting before cleaning (s) 90 104 90
Time before return to initial state (s) 270 270 240
% of freezing of the fibrin 100 100 98 Contact ++ + +Λ
Temperature at the thermocouple (°C):
Initial temperature TO -15 -15 -15
Highest temperature Tmax -9.6 -10 -10.1
Temperature at 30 s (withdrawal of the appliance) -10.7 -10.3 -10.3
Temperature delta (jTmax - TOj) 5.4 5 4.9
Time waiting before cleaning (s) 60 60 60
Time before return to initial state (s) 240 210 180
% of freezing of the fibrin 100 98 80
Figure imgf000014_0001
Figure imgf000014_0002
For the test specimen at -5°C there was no freezing, whatever the type of contact made (percentage freezing <5%). At -17°C, freezing was effective, around 100% for all tests. At the temperatures of -15°C and -10°C, the percentage freezing varies from 100% to 50% according to our tests. It may be seen that the frozen fibrin is very hard; it easily breaks into large pieces. Then as it thaws it changes texture, becoming less sticky (more gelatinous in appearance). It easily breaks up into small bits. It can then be scooped up with a curette like a ball of ice-cream, making it easy to handle for cleaning.
It may also be noted that after a certain period of time (time before returning to the initial state), the fibrin readopts a more viscous and stringy gel appearance closely resembling that of its initial state.
Contact times other than 30 seconds were then tested in order to study the impact that had on the freezing of the test specimens.
The results obtained are set out in Table 2 below.
TABLE 2
Figure imgf000015_0001
It may be noted that at a temperature of -15°C, contact for 10 seconds is enough to freeze the test specimens. This shorter contact time means that there is less of a wait before being able to handle the fibrin easily using a curette, and this may prove advantageous because care personnel can save time when administering care to the patients.
Thus these various experiments demonstrate that the optimal conditions obtained to achieve 100% freezing and fibrin that can easily be handled using a curette are a temperature of -15°C and light contact for a time of 10 seconds.

Claims

1. Device intended to be applied to the skin, comprising a coldness generator (113), characterized in that the coldness generator (113) cools the skin to a temperature of between -30°C and 0°C for a coldness duration of between 1 and 300 seconds.
2. Device according to Claim 1, in which the coldness generator (113) cools the skin to a temperature of between -20°C and -5°C, preferably of between -15°C and -10°C, for a coldness duration of between 5 and 60 seconds, preferably of between 10 and 20 seconds.
3. Device according to Claim 1, in which the coldness generator (113) cools the skin to a temperature of -15°C for a coldness duration of 10 seconds.
4. Device according to any one of Claims 1 to 3, comprising a coldness-conducting tip (112) able to transfer heat energy between the skin and the coldness generator.
5. Device according to Claim 4, in which the coldness-conducting tip (112) does not stick to the skin.
6. Device according to Claim 4 or 5, in which the coldness- conducting tip (112) is covered with a material capable of being applied to the skin.
7. Device according to Claim 6, in which the material capable of being applied to the skin is chosen from superabsorbent fibres, non-adherent compresses, absorbent dressings and dressings containing a hydrocolloid mass.
8. Device according to any one of Claims 4 to 7, in which the coldness-conducting tip (112) is made of a metal chosen from copper, silver, gold, aluminium, zinc, nickel, iron, palladium, platinum, tin and lead, or from an alloy based on one of these metals, this tip preferably being made of copper.
9. Device according to any one of Claims 4 to 8, in which the coldness-conducting tip (112) is removable.
10. Device according to any one of Claims 1 to 9, in which said device comprises a control element (109) for controlling the coldness duration, particularly a timer, and a temperature control element, particularly a microcontroller associated with a temperature sensor.
11. Device according to any one of Claims 1 to 10, in which the coldness generator may be chosen from:
- a cooled element;
- a Peltier-effect module;
- a compressor;
- a Stirling type engine.
12. Method in which a device according to any one of Claims 1 to 11 is applied to the skin for the purposes of cryotherapy, cryosurgery, wound treatment, healing treatment, postoperative treatment, local pain treatment, an aesthetic application, a dermocosmetic application and/or for muscle recovery.
13. Method according to Claim 12, in which the device is used for the cleaning of a wound.
14. Method according to Claim 13, in which, after having cooled the necrotic and/or fibrinous tissues of the wound, these tissues are removed, for example using a curette.
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