WO2009083688A2 - Device intended for heat administration into a human or animal tissue, vessel or cavity - Google Patents

Device intended for heat administration into a human or animal tissue, vessel or cavity Download PDF

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Publication number
WO2009083688A2
WO2009083688A2 PCT/FR2008/052381 FR2008052381W WO2009083688A2 WO 2009083688 A2 WO2009083688 A2 WO 2009083688A2 FR 2008052381 W FR2008052381 W FR 2008052381W WO 2009083688 A2 WO2009083688 A2 WO 2009083688A2
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WO
WIPO (PCT)
Prior art keywords
tube
micro
resistivity
resistance
distal
Prior art date
Application number
PCT/FR2008/052381
Other languages
French (fr)
Other versions
WO2009083688A3 (en
Inventor
Henri Mehier
Original Assignee
Henri Mehier
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 Henri Mehier filed Critical Henri Mehier
Priority to CA2709335A priority Critical patent/CA2709335A1/en
Publication of WO2009083688A2 publication Critical patent/WO2009083688A2/en
Publication of WO2009083688A3 publication Critical patent/WO2009083688A3/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
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/44Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for cooling or heating the devices or media
    • 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
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • 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
    • A61B2018/00345Vascular system
    • A61B2018/00404Blood vessels other than those in or around the heart
    • 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
    • A61B2018/00458Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
    • A61B2018/00464Subcutaneous fat, e.g. liposuction, lipolysis
    • 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
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • 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
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B2018/044Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid
    • A61B2018/046Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid in liquid form
    • 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
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B2018/044Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid
    • A61B2018/048Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid in gaseous form
    • 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
    • A61F2007/0059Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit
    • A61F2007/006Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit of gas
    • A61F2007/0062Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit of gas the gas being steam or water vapour
    • 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
    • A61F7/12Devices for heating or cooling internal body cavities
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/08Lipoids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0045Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked

Definitions

  • the invention relates to a new device for the administration of calories, for example in the form of water vapor in a cavity (bladder etc.), a human or animal tissue or vessel.
  • the device of the invention can be used for the treatment of tumors by the so-called "thermoablation” technique.
  • calories can be generated to heat the water that the tumor contains, or to vaporize water brought from outside the body (in the body). hypothesis or water content is too low to effect efficient thermoablation).
  • the device is adapted to eliminate excess subcutaneous fat by the so-called "liposuction" technique.
  • the device of the invention is also intended, when it is used endoluminally, for the treatment of venous or arteriovenous pathologies, in particular varicose veins, hemorrhoids, arteriovenous shunts and other vascular malformations.
  • venous or arteriovenous pathologies in particular varicose veins, hemorrhoids, arteriovenous shunts and other vascular malformations.
  • the blood contains a certain proportion of water, it may be preferable to use the calories to heat the water contained in the blood at a temperature of the order of 95 ° C, rather than the water brought from outside the body.
  • the Applicant has developed a number of devices for injecting water vapor into tissues or vessels.
  • the general principle common to all these devices is to maintain the water before release, in pressurized form, that is to say liquid at a temperature above 100 0 C, which allows to have a transfer optimized calories between the heat source and pressurized water.
  • the water circulates in a restricted space, in practice in the light of a micro tube of diameter between 100 and 250 microns.
  • thermoablation by heat technique of injecting continuously, by means of a microtube, directly into the tissues of the body, pressurized water or hydrogen peroxide. a temperature of 200 to 400 ° C.
  • the Applicant proposes an improved thermoablation method in that it plans to inject the heat transfer fluid into the microtube no longer continuously, but in pulsed form, which makes it possible to avoid the diffusion of heat outside the area to be treated by quickly bringing the calories into the area to be treated.
  • the heating system is outside the body and remains unchanged. It consists, essentially, in a metal coil incorporating an electrical resistance around which is surrounded the stainless microtube in which circulates the coolant.
  • these methods involve heating the water through the wall of the tube.
  • This approach may have certain drawbacks and in particular that of causing necrosis of tissues or vessels by "dry" heat to the extent that the temperature of the tube may exceed 400 to 500 ° C.
  • the phenomenon of "dry" heat necrosis causes the formation of CO 2 , responsible for air embolism, as well as the formation of toxins.
  • this solution provides calories only in the area to be treated, it does not limit the phenomenon of dry heat. It also remains very expensive since it requires the deposition, under vacuum, of insulating layers, requiring a delicate polishing of the tube, as well as the deposition of very thin conductive materials of the order of 200 to 500 nanometers inherent in vacuum deposition, necessarily limiting the supply of electric current and therefore the available energy in the area to be treated. In addition, the deposition in thin layer, under the effect of heat can crack and therefore spread in the tissues of the body, especially in pulsed injection regimes, with alternating hot or cold.
  • US2007 / 0032785A1 discloses an implantable device capable of diffusing water vapor into a tissue.
  • the device consists of two concentric tubes between the walls of which circulates water.
  • the water is pressurized at the distal end for injection into the tissues through orifices.
  • the pressurized water is heated along the entire length of the peripheral tube via electrodes. More specifically, the peripheral tube is traversed by a current generated by an electrode, towards the distal end of the device, then the current returns to the proximal portion by traversing the inner tube.
  • the tissue or vessel may also be an interest in directly heating the tissue or vessel by generating a sufficient amount of calories to increase the temperature of the water contained in the tissue or vessel at a temperature of about 95 ° C. This is particularly the case for the treatment of varicose veins.
  • the heating must remain elective and applied only at the level of the varix and not around.
  • no device fulfilling this purpose has been described, with the exception of the laser. Nevertheless, laser technology is not optimal. Indeed the laser generates a point heat, causing the formation of micro-hematoma in the venous wall.
  • the problem is to develop implantable devices capable of generating calories exclusively in the area to be treated, that these calories can either heat the water contained in the area to be treated, or spray the water. water brought from outside the body.
  • Another object of the invention is to develop a device whose implanted part is of the smallest possible size, so as to be introduced into any type of cavity (bladder etc.), fabric or human or animal vessel.
  • the Applicant has managed to develop a micro-resistance in all or part implantable for the delivery of calories in a cavity, a tissue or a vessel, the heating of which is offset at the distal end of said micro-resistance.
  • the micro-resistance of the invention has only a distal heating zone, which makes it possible to avoid any heating of the tissues outside this zone.
  • the subject of the invention is a micro-resistance in whole or in part implantable intended for the administration of calories in a cavity, a tissue or a vessel in the form of a resistivity metal tube R1 having ends proximal and distal and enveloping an electrically conductive material (in the form of a wire or a tube) of resistivity R2 at least 5 times, advantageously at least 15 times greater than R1, said electrically conductive material being connected at the distal closed end of the resistivity metal tube R1 at its end end and having, upstream of said terminal end, two distinct portions, a medial and proximal portion covered with: a first layer of a conductive material; resistivity electricity
  • the diameter of the micro-resistor, when it is implanted as such is between 0.2 and 0.8 mm.
  • said "second insulating layer" is advantageously resistant to a temperature of 200 ° C. and made from a material chosen from the group comprising teflon®, polyimide and alumina.
  • the insulating layer is trapped in the peripheral tube and is not likely to diffuse into the body in case of cracking.
  • the current flows in practice from the + pole of the generator to the pole - passing successively by the resistivity layer R3 at the proximal and median portions of the conductive material and then in the electrically conductive material of R2 resistance on the distal portion.
  • the current then passes into the wall of the resistivity metal tube R1 at the end end without insulating layer, the electrically conductive material resistivity R2, to return to the generator.
  • the distal end of the electrically conductive material has a resistivity R2, at least 5 times greater than the resistivity R3, it follows a warming of the micro-resistance exclusively at the distal portion of the tube, at a temperature in practice of about 200 ° C.
  • the value of the resistivity R1 is substantially equal to the value of the resistivity R3.
  • the resistivity metal tube R1 and the first layer of a resistivity-conducting electrically conductive material R3 are made of copper, in particular by electrolytic deposition or by crimping, the resistivity of the copper being 1.7 ⁇ cm.
  • the copper layer applied to the resistivity material R2 has, in practice, a thickness of between 10 and 40 microns, advantageously of the order of 30 microns.
  • the electrically conductive material of resistivity R2 is in the form of a constantan wire, that is to say a copper / nickel alloy whose resistance is independent of temperature or a wire made of a nickel / chromium alloy.
  • the constantan resistivity is 50 ⁇ cm while the nickel / chromium alloy has a resistivity of 110 ⁇ cm.
  • the constantan or the nickel / chromium alloy may possibly be replaced by stainless steel. However, the deposit of copper on the stainless steel remains delicate.
  • the constantan or the nickel / chromium alloy gives the micro-resistance a certain flexibility.
  • the electrically conductive material resistivity R2 is not in the form of a wire but in the form of a tube possibly closed at its distal portion and into which is introduced a removable stainless steel needle, conferring on the system a certain rigidity.
  • the constantan or nickel / chromium alloy tube replacing the constantan or nickel / chromium alloy wire, coated with the first and second insulating layers as previously described, is placed in the metal resistivity tube.
  • the end end of the resistivity conductive material tube R2 in contact with the distal end of the resistivity metal tube R1 is devoid of an insulating layer thereby allowing the passage of the current from one tube to the other.
  • the micro-resistance of the invention as just described can be used as such, that is to say without external water supply, particularly for the treatment of varicose veins according to a process which will be described later.
  • the micro-resistance of the invention can be used as a heating means for vaporizing water brought from outside the body, like the systems described in the state. of the technique.
  • the subject of the invention is a device that is wholly or partially implantable for the administration of water vapor in a tissue or vessel, which is characterized in that:
  • a peripheral tube consisting of distal, medial and proximal parts, said tube containing in its light, throughout its length, a micro-resistance of the type described above, the water being intended for circulating in the dead space separating the wall of the tube from the micro-resistance, the proximal portion of the tube has a Y end, one outlet of which is intended to be connected directly to a water inlet, and the other of which is partially closed to allow passage of the connection means of the micro-resistance to the terminals of the current generator.
  • the water is no longer heated through the wall of the tube, but by means of an electrical resistance incorporated in the tube lumen, at the distal end thereof.
  • the temperature gradient is reversed compared to the system of the prior art, that is to say that it decreases from the center to the periphery of the tube and not the opposite.
  • the second condition for transforming water into steam at the time of release thus remains its transfer into the tube in pressurized form, which is made possible by the implementation of a restricted volume in which the water circulates.
  • One of the advantages of the newly proposed solution is that there is no longer any dimensional constraint for the realization of the tube ensuring the transfer of water, since it is sufficient to defining a sufficiently small volume between the wall of the tube and the central micro-resistance so that the water is in the pressurized state at the distal end of the tube.
  • the wall therefore reaches a temperature lower than that of the water vapor, thus limiting the effect of the heating produced to a phenomenon of thermonecrosis or thermofibrosis but in no case to a necrosis phenomenon by dry heat.
  • the difference in resistivity between the peripheral tube enveloping the micro-resistance (at its distal portion) and the microresistance itself being very high, this makes it possible to selectively heat the liquid in pressurized form, exclusively at the level of the distal end of the tube.
  • the difference in diameter between the internal diameter of the tube and the diameter of the micro-resistance is between 50 and 100 microns.
  • the outer diameter of the tube is between 0.3 and 1 mm, and the internal diameter is between 0.2 and 0.8 mm.
  • the fact of being able to implement microresistances of diameter close to 0.8 mm, while maintaining a reduced dead space, makes it possible to generate a larger heating surface, improving the transfer of calories. It is thus possible to reduce the length of the micro-resistor in its distal part, which makes it possible to concentrate the heating in the zone to be treated.
  • the peripheral tube is divided into three distinct parts respectively a distal portion, a medial portion and a proximal portion.
  • the micro-resistance remains relatively flexible because of its structure associating, advantageously, copper and constantan or nickel / chromium.
  • the distal and median portions of the peripheral tube may be in the form of a needle, preferably selected from stainless steel.
  • the peripheral tube may be in the form of a catheter.
  • the distal and medial parts are made of a material selected from the group comprising PEEK, PTFE and polyphenylsulfone or a super-soft alloy of the nickel / titanium type marketed under the trade name Ritinol®.
  • the distal portion of the peripheral tube may be open or closed. In this second case, it is laterally provided with perforations having a size of between 50 ⁇ m and 150 ⁇ m, advantageously equal to 70 ⁇ m.
  • proximal part this may be made of a flexible material, such as, for example, silicone, the junction between the silicone part and the needle or the catheter being performed by any connection means known to those skilled in the art, and in particular by screwing or gluing.
  • a flexible material such as, for example, silicone
  • this connection is secured by the establishment of a gripping sleeve covering the junction between the middle portion and the proximal portion of the tube.
  • the proximal portion is in the form of a Y-shaped part, an outlet of which is connected sealingly, for example by means of a luer, to a water supply and the other outlet is electrically isolated and partially closed to allow passage of the connection means of the micro-resistance to the terminals of the current generator.
  • the device as just described has the further advantage of being inexpensive in terms of manufacturing. Therefore, it is a consumable device and thus completely eliminate the problem of contamination.
  • the device can be used for the treatment of tumors by inserting the micro-resistance associated or not with a peripheral catheter or needle directly into the tissue. This is a function of the content of the tumor in water, being reminded that if this content is sufficient, micro-resistance alone can heat the water contained in the tumor at a temperature of about 95 ° C.
  • the device can also be used endoluminally, for the treatment of other pathologies, such as for example the treatment of varicose veins. All of these techniques are described in the aforementioned documents of the Applicant.
  • the invention therefore also relates to a method for treating tumors by administering calories comprising: incising the skin and then introducing into the target tissue the distal and medial portions of the micro-resistance or the device (microresistance + peripheral tube ), then, supplying the micro-resistance with electricity and if necessary simultaneously and continuously, the tube with water, so as to heat the water by maintaining it in the pressurized state at the distal end of the tube before injection into the tissue, remove the device at the end of treatment.
  • the distal and middle portions of said tube are in the form of a needle, the needle is directly stitched into the tissue to be treated.
  • the distal and median portions of said tube are in the form of a catheter, it is introduced directly into the body, the rigidity of the catheter being obtained by the implementation of a tube of constantan or nickel / chrome provided with a removable stainless steel rod, instead of constantan wire or nickel / chrome.
  • the invention also relates to a method for treating arteriovenous pathologies by injecting endoluminal calories into the vessels, consisting of:
  • micro-resistance + peripheral tube To incise the skin, then to introduce in the vessels the distal and medial parts of the micro-resistance or the device (micro-resistance + peripheral tube), - then, to feed the micro-resistance in electricity and if necessary simultaneously, and continuously , the tube in water, so as to heat the water by maintaining it in the pressurized state at the distal end of the tube before injection into the vessels, to remove the device at the end of treatment.
  • the subject of the invention is a method for treating varicose veins by endoluminal injection of calories, under local or general anesthesia, consisting in: performing a tracing of the vein to be treated, by marking on the skin the path of the vein and the introduction orifice of the device,
  • micro-resistance + peripheral tube to treat the distal and medial portions of the micro-resistance or the device (microresistance + peripheral tube), then, to supply the micro-resistance with electricity and if necessary simultaneously, and continuously, the tube in water, so as to heat the water by maintaining it in the pressurized state at the distal end of the tube before injection into the vein, to gradually remove the device.
  • the subject of the invention is also, in the particular case where there is water vapor injection, an installation for implementing said endoluminal variceal treatment method, comprising the device previously described, the end of which is Y of the proximal part is connected by its first branch to a water injection system and by its second branch to a current source.
  • the water injection system is in the form of a flexible tube directly sealingly connected to the Y, the tube being compressed, at its proximal end, between two fixed rollers. rotated at the same speed by means of a motor, in the opposite direction to that of the vein to be treated.
  • the movement of the rollers thus causes the injection of the actual water into the device of the invention and simultaneously the regular retreat and thus the removal of the device from the vein.
  • the present device can also be adapted to eliminate excess fat by the so-called "liposuction" technique.
  • the first is to introduce, subcutaneously, a cannula whose distal end is provided with an ultrasound system whose function is to break the membrane of adipocytes.
  • This device has the essential disadvantage of being very expensive since manufactured from non-consumable materials. This leads to potential risks of contamination.
  • Another technique consists in treating cellulite by destroying the adipocytes by heat by means of a laser beam. This technique has the main disadvantage of generating a point heat that can cause tissue necrosis by dry heat.
  • the Applicant has found that its device could be used to reduce cellulite with some adaptations, including providing a peripheral sheath provided with lateral perforations arranged around the tube at least in its distal portion and connected to a suction system.
  • thermofibrosis that is to say the retraction of the collagen fibers (heating at 85.degree. minus 15 seconds) thus allowing to retension the skin.
  • necrosis of the subcutaneous tissue by dry heat.
  • the invention also relates to a method for removing excess fat from the human body implementing the device described above.
  • the method consists in: - incising the skin, then introducing subcutaneously into the adipose tissue the distal and medial parts of the device (microresistance + peripheral tube), then, simultaneously, and continuously, feeding the tube in water and means of heating electricity, so as to heat the water by maintaining it in the pressurized state at the distal end of the tube before injection into the tissue, to suck the fat cells destroyed by the steam water, - remove the device at the end of treatment.
  • Figure 1 is a schematic sectional representation of a device of the invention used directly in tissues or endoluminally.
  • Figure 2 is a schematic sectional representation of the device of the invention adapted for the removal of excess fat.
  • Figure 3 is a detailed sectional representation of the microresistor of the invention according to a first embodiment.
  • Figure 4 is a detailed sectional representation of the micro-resistor according to a second embodiment.
  • Figure 5 is a schematic representation of an installation for treating varicose veins.
  • the device of the invention consists of a peripheral tube (1) which can be divided into two parts, respectively: distal and medial implantable parts (2), and a non-implanted part (3) corresponding to the proximal portion of the device.
  • the implantable portion is in the form of a beveled needle made of stainless steel whose internal diameter is for example equal to 0.8 mm while the outer diameter is 1 mm.
  • this needle can be replaced by a catheter of equivalent dimensions made for example PEEK.
  • This implantable portion is connected to the proximal portion (3) not implanted sealingly for example by gluing (4).
  • the non-implanted portion is in the form of a Y, made of silicone, one of the branches (5) is intended to be connected to a water inlet (6), and the other branch (7) is partially closed to allow passage of the connection means (8) of the microresistor (9) to the terminals of the current generator (10).
  • said device is provided with a sleeve (11) of silicone covering the tube (1) at the junction of the medial and proximal parts.
  • the peripheral tube (1) comprises, in its light, a microresistor designated by the general reference (9), the distal end of which is aligned with the distal end of the peripheral tube.
  • the distal end of the microresistor has a rounded shape and extends beyond the distal end of the peripheral tube.
  • This embodiment is more particularly suitable for the treatment of varicose veins because it is necessary not to alter the wall of the vein to be treated by an angular end.
  • the micro-resistance presents, in this example, an outer diameter of 0.75 mm leaving a reduced dead space of 50 microns between said microresistor (9) and the inner surface of the tube (1).
  • FIG. 3 shows the microresistor (9) of the invention.
  • this micro-resistance is in the form of a casing tube (11) made of copper, with a diameter of 0.750 mm.
  • the constituent copper of the tube has a resistivity R1 of 1.7 ⁇ cm.
  • the tube (11) contains in its lumen a current-conducting wire (12), whose end end (13 ') of the distal portion (13) is connected by laser welding or crimping to the distal end (14) of the tube (11).
  • This wire is a constantan wire, with a diameter of 0.3 mm or a wire of a nickel / chromium alloy with a diameter of 0.26 mm having two distinct portions.
  • the medial and proximal portions of the wire (12) are covered with a first layer of electrolytic copper (15) of a thickness of 30 microns, then a second layer (16) of an electrical insulator.
  • the constantan wire is free of electrolytic copper coating (15), but is electrically insulated (16) with the exception of the terminal end itself, which is crimped or soldered to the resistivity tube. Rl.
  • the copper coating (15) applied to the wire (12) is connected (8) to the + terminal of the current generator (10) while the peripheral wrapping tube (11) is connected ( 8) to the - terminal of the same generator (10).
  • the electric current flows to the distal end of the microresistor in the copper coating (15) applied around the wire. Near the end of the tube, the electricity passes into the distal portion of the wire (12) to return thereafter to the generator (10) while traveling in the wall of the peripheral tube (11).
  • the presence of a copper coating (15) applied to the medial and proximal portions of the wire (12) prevents heating of the wrapping tube (11) over the entire length of the device (due to the difference in resistivity between the wire and the constituent copper of the enveloping tube).
  • the resistivity of the constantan wire R2 is about 50 ⁇ cm or the nickel / chromium alloy wire is about 110 ⁇ cm, while the resistivity of the electrolytic copper R3 is of the order of 1.7 ⁇ cm .
  • This difference in resistivity allows heating of the water circulating between the inner wall of the tube of the device and the outer wall of the wrapping tube, exclusively at the distal portion of the microresistor (9), to a value of approximately 400 ° C. C.
  • FIG. 4 shows another embodiment of the microresistor more particularly adapted to the case in which the implantable portion is in the form of a flexible catheter (20).
  • the principle is to compensate for the flexibility of the catheter added to that of the micro-resistance, by implementing the constantan or the nickel / chromium alloy not in the form of a wire but in the form of a hollow tube (25). in which is inserted removably a stainless steel rod (21). In practice, the stainless steel rod is removed once the implanted tube.
  • the device of the invention can be implanted directly into the tissues or vessels endoluminally.
  • the needle or the implantable catheter are inserted into the body to reach the tumor or the vessel to be treated.
  • the micro-resistance is introduced alone, without peripheral tube.
  • the current generator is actuated so as to route the current in the microresistor.
  • the water is injected into the reduced dead space, thus making it possible to heat the water gradually to reach, at the distal end, a temperature of 200 ° C., the water then being in pressurized form, that is to say liquid at a temperature above 100 ° C.
  • the water, in this zone, being at a temperature of about 200 ° C., is propelled continuously or discontinuously outside the catheter or of the needle through its open distal end, and immediately turns into vapor after release.
  • the device is adapted to allow its use for the extraction of grease, and in particular cellulite.
  • This technique known by the term “liposuction”, may advantageously be implemented by means of the device of the invention when it is covered, at its periphery, with a sheath (17) connected to a vacuum system. suction (18) of the adipocytes, the sheath being provided with a number of lateral perforations (19).
  • the implantable tube which, in practice, has a length of about 30 cm, is introduced into the subcutaneous adipose tissue, the microresistance is then supplied with current so as to heat the tube enveloping at its distal end. At the same time, the water is propelled into the dead space and then heated and pressurized at the distal end. At the outlet, the water is transformed into vapor and allows not only the removal of adipocytes, but also thermofibrosis, that is to say the retraction of collagen. At the same time, the excess fat is sucked into the sheath by suction means.
  • the device of the invention is combined with a specific system of water injection, in the context of treatment varicose veins.
  • the device of the invention designated by the general reference (1) is connected at its proximal end to a water injection system in the form of a flexible tube (22), pressed between two rollers (23.24), said roll being rotated about their axis, at identical speed, by means of a motor not shown.
  • a water injection system in the form of a flexible tube (22), pressed between two rollers (23.24), said roll being rotated about their axis, at identical speed, by means of a motor not shown.
  • the size and the volume of the flexible tube are determined to contain the entire volume of water necessary for the treatment of the targeted vein. The movement of the rollers thus causes the injection of the actual water into the device of the invention and simultaneously the regular retreat and thus the removal of the device from the vein.
  • Another advantage of the invention remains the low cost that can lead to the marketing of a consumable device, thus avoiding any risk of infection that is known with the means currently implemented on the market.

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Abstract

A completely or partly implantable microresistor (9) intended for heat administration into a cavity, tissue or vessel, taking the form of a metal tube (11) of resistivity R1 surrounding an electrically conductive material (12) of resistivity R2 at least 5 times greater than R1, and having: a proximal and median portion coated with a layer (15) of an electrically conductive material and then with a second, insulating, layer, and a distal portion coated only with an insulating layer (16). A completely or partly implantable device intended for the administration of steam into a tissue or vessel provided with said microresistor.

Description

DISPOSITIF DESTINE A L'ADMINISTRATION DE CALORIES DANS UN TISSU, VAISSEAU OU CAVITE HUMAINE OU ANIMALE DEVICE FOR ADMINISTERING CALORIES IN HUMAN OR ANIMAL TISSUE, VESSEL OR CAVITY
L'invention a pour objet un nouveau dispositif destiné à l'administration de calories, par exemple sous la forme de vapeur d'eau dans une cavité (vessie etc.), un tissu ou vaisseau humain ou animal.The invention relates to a new device for the administration of calories, for example in the form of water vapor in a cavity (bladder etc.), a human or animal tissue or vessel.
Le dispositif de l'invention peut être utilisé pour le traitement des tumeurs par technique dite "de thermoablation". En fonction de la nature de la tumeur, en particulier sa teneur en eau, les calories peuvent être générées pour chauffer l'eau que la tumeur contient, ou pour vaporiser de l'eau apportée depuis l'extérieur de l'organisme (dans l'hypothèse ou la teneur en eau est trop faible pour effectuer une thermoablation efficace). Dans un mode de réalisation particulier, le dispositif est adapté pour éliminer les excès de graisses sous- cutanées par la technique dite "de liposuccion".The device of the invention can be used for the treatment of tumors by the so-called "thermoablation" technique. Depending on the nature of the tumor, particularly its water content, calories can be generated to heat the water that the tumor contains, or to vaporize water brought from outside the body (in the body). hypothesis or water content is too low to effect efficient thermoablation). In a particular embodiment, the device is adapted to eliminate excess subcutaneous fat by the so-called "liposuction" technique.
Le dispositif de l'invention s'adresse également, lorsqu'il est utilisé par voie endoluminale, au traitement des pathologies veineuses, ou artérioveineuses, en particulier des varices, des hémorroïdes, des shunts artérioveineux et autres malformations vasculaires. Dans ce cas, dans la mesure où le sang contient une certaine proportion d'eau, on pourra préférer utiliser les calories pour chauffer l'eau contenue dans le sang à une température de l'ordre de 95°C, plutôt que de l'eau apportée depuis l'extérieur de l'organisme.The device of the invention is also intended, when it is used endoluminally, for the treatment of venous or arteriovenous pathologies, in particular varicose veins, hemorrhoids, arteriovenous shunts and other vascular malformations. In this case, since the blood contains a certain proportion of water, it may be preferable to use the calories to heat the water contained in the blood at a temperature of the order of 95 ° C, rather than the water brought from outside the body.
Jusqu'alors, le Demandeur a mis au point un certain nombre de dispositifs permettant d'injecter de la vapeur d'eau dans des tissus ou des vaisseaux. Le principe général commun à l'ensemble de ces dispositifs est de maintenir l'eau avant sa libération, sous forme pressurisée, c'est-à-dire liquide à une température supérieure à 1000C, ce qui permet d'avoir un transfert de calories optimisé entre la source de chaleur et l'eau sous forme pressurisée. Pour ce faire, dans toutes les solutions proposées par le Demandeur jusqu'alors, l'eau circule dans un espace restreint, en pratique dans la lumière d'un micro tube de diamètre compris entre 100 et 250 μm.Until now, the Applicant has developed a number of devices for injecting water vapor into tissues or vessels. The general principle common to all these devices is to maintain the water before release, in pressurized form, that is to say liquid at a temperature above 100 0 C, which allows to have a transfer optimized calories between the heat source and pressurized water. To do this, in all the solutions proposed by the Applicant until now, the water circulates in a restricted space, in practice in the light of a micro tube of diameter between 100 and 250 microns.
Le document WO 00/29055 décrit ainsi une technique de thermoablation par la chaleur consistant à injecter en continu, par le biais d'un microtube, directement dans les tissus de l'organisme, de l'eau ou de l'eau oxygénée pressurisées à une température de 200 à 4000C.The document WO 00/29055 thus describes a thermoablation by heat technique of injecting continuously, by means of a microtube, directly into the tissues of the body, pressurized water or hydrogen peroxide. a temperature of 200 to 400 ° C.
Dans le document WO 03/070302, le Demandeur propose une méthode de thermoablation perfectionnée en ce qu'elle prévoit d'injecter le liquide caloporteur dans le microtube non plus en continu, mais sous forme puisée, ce qui permet d'éviter la diffusion de chaleur en dehors de la zone à traiter en apportant rapidement les calories dans la zone à traiter. Dans les deux cas, le système de chauffage est à l'extérieur de l'organisme et reste inchangé. Il consiste, pour l'essentiel, en une bobine métallique incorporant une résistance électrique autour de laquelle est entouré le microtube inox dans lequel circule le fluide caloporteur. En d'autres termes, ces procédés consistent à chauffer l'eau par le biais de la paroi du tube. Cette approche peut présenter certains inconvénients et notamment celui d'entraîner des nécroses des tissus ou des vaisseaux par chaleur « sèche » dans la mesure où la température du tube peut dépasser 400 à 5000C. Le phénomène de nécrose par chaleur « sèche », à très haute température, entraîne la formation de CO2, responsable d'embolie gazeuse, de même que la formation de toxines.In the document WO 03/070302, the Applicant proposes an improved thermoablation method in that it plans to inject the heat transfer fluid into the microtube no longer continuously, but in pulsed form, which makes it possible to avoid the diffusion of heat outside the area to be treated by quickly bringing the calories into the area to be treated. In both cases, the heating system is outside the body and remains unchanged. It consists, essentially, in a metal coil incorporating an electrical resistance around which is surrounded the stainless microtube in which circulates the coolant. In other words, these methods involve heating the water through the wall of the tube. This approach may have certain drawbacks and in particular that of causing necrosis of tissues or vessels by "dry" heat to the extent that the temperature of the tube may exceed 400 to 500 ° C. The phenomenon of "dry" heat necrosis, at very high temperatures, causes the formation of CO 2 , responsible for air embolism, as well as the formation of toxins.
Pour résoudre ce problème, le Demandeur a proposé dans le document WO 2006/108974, de chauffer le tube exclusivement au niveau de son extrémité distale, par le biais d'un courant électrique parcourant le microtube et constituant la source de calories. On évite ainsi de chauffer des parties du tube non en contact avec la tumeur à traiter. Pour limiter réchauffement de la partie distale du tube, ledit tube est recouvert d'une gaine réalisée en un revêtement électrolytique d'or d'épaisseur d'environ 1 μm.To solve this problem, the Applicant proposed in WO 2006/108974, to heat the tube exclusively at its distal end, through an electric current flowing through the microtube and constituting the source of calories. This avoids heating parts of the tube not in contact with the tumor to be treated. To limit the heating of the distal portion of the tube, said tube is covered with a sheath made of an electrolytic coating of gold approximately 1 μm thick.
Si cette solution permet d'apporter des calories uniquement dans la région à traiter, elle ne permet pas de limiter le phénomène de chaleur sèche. Elle reste en outre très onéreuse puisqu'elle requiert le dépôt, sous vide, de couches isolantes, nécessitant un polissage délicat du tube, de même que le dépôt de matériaux conducteurs de très faible épaisseur de l'ordre de 200 à 500 nanomètres inhérent au dépôt sous vide, limitant forcément l'apport du courant électrique et donc l'énergie disponible dans la zone à traiter. En outre, le dépôt en couche mince, sous l'effet de la chaleur peut se craqueler et donc se répandre dans les tissus de l'organisme, surtout en régimes puisés d'injection, avec alternance de chaud ou de froid.If this solution provides calories only in the area to be treated, it does not limit the phenomenon of dry heat. It also remains very expensive since it requires the deposition, under vacuum, of insulating layers, requiring a delicate polishing of the tube, as well as the deposition of very thin conductive materials of the order of 200 to 500 nanometers inherent in vacuum deposition, necessarily limiting the supply of electric current and therefore the available energy in the area to be treated. In addition, the deposition in thin layer, under the effect of heat can crack and therefore spread in the tissues of the body, especially in pulsed injection regimes, with alternating hot or cold.
Le document US2007/0032785A1 décrit un dispositif implantable apte à diffuser de la vapeur d'eau dans un tissu. Le dispositif est constitué de deux tubes concentriques entre les parois desquels circule de l'eau. L'eau est pressurisée à l'extrémité distale pour être injectée ensuite dans les tissus par le biais d'orifices. L'eau pressurisée est chauffée sur toute la longueur du tube périphérique par le biais d'électrodes. Plus précisément, le tube périphérique est parcouru par un courant généré par une électrode, en direction de l'extrémité distale du dispositif, puis le courant revient vers la partie proximale en parcourant le tube interne. Même si un tel système permet de diminuer sensiblement la température de la paroi périphérique, celle-ci reste relativement élevée et est susceptible d'entrainer des phénomènes de thermonécrose, de thermofibrose mais également de nécrose par chaleur sèche en dehors de la zone à traiter. Comme mentionné en préambule, il peut également y avoir un intérêt à chauffer directement le tissu ou le vaisseau en générant une quantité de calories suffisante pour permettre d'augmenter la température de l'eau contenue dans le tissu ou le vaisseau à une température d'environ 95°C. C'est notamment le cas pour le traitement des varices. Toutefois, le chauffage doit rester électif et n'être appliqué qu'au niveau de la varice et non aux alentours. A la connaissance du Demandeur, aucun dispositif remplissant cet objectif n'a été décrit, à l'exception du laser. Néanmoins, la technologie du laser n'est pas optimale. En effet le laser génère une chaleur ponctuelle, provoquant la formation de micro -hématomes dans la paroi veineuse.US2007 / 0032785A1 discloses an implantable device capable of diffusing water vapor into a tissue. The device consists of two concentric tubes between the walls of which circulates water. The water is pressurized at the distal end for injection into the tissues through orifices. The pressurized water is heated along the entire length of the peripheral tube via electrodes. More specifically, the peripheral tube is traversed by a current generated by an electrode, towards the distal end of the device, then the current returns to the proximal portion by traversing the inner tube. Although such a system can significantly reduce the temperature of the peripheral wall, it remains relatively high and is likely to cause thermonecrosis phenomena, thermofibrosis but also dry heat necrosis outside the area to be treated. As mentioned in the preamble, there may also be an interest in directly heating the tissue or vessel by generating a sufficient amount of calories to increase the temperature of the water contained in the tissue or vessel at a temperature of about 95 ° C. This is particularly the case for the treatment of varicose veins. However, the heating must remain elective and applied only at the level of the varix and not around. To the knowledge of the Applicant, no device fulfilling this purpose has been described, with the exception of the laser. Nevertheless, laser technology is not optimal. Indeed the laser generates a point heat, causing the formation of micro-hematoma in the venous wall.
En d'autres termes, le problème posé est de mettre au point des dispositifs implantables aptes à générer des calories exclusivement dans la zone à traiter, que ces calories permettent soit de chauffer l'eau contenue dans la zone à traiter, soit de vaporiser l'eau apportée depuis l'extérieur de l'organisme. Un autre objectif de l'invention est de mettre au point un dispositif dont la partie implantée soit d'une taille la plus faible possible, de sorte à pouvoir être introduit dans n'importe quel type de cavité (vessie etc.), tissu ou vaisseau humain ou animal.In other words, the problem is to develop implantable devices capable of generating calories exclusively in the area to be treated, that these calories can either heat the water contained in the area to be treated, or spray the water. water brought from outside the body. Another object of the invention is to develop a device whose implanted part is of the smallest possible size, so as to be introduced into any type of cavity (bladder etc.), fabric or human or animal vessel.
Pour ce faire, le Demandeur a réussi à mettre au point une micro -résistance en tout ou partie implantable destinée à l'administration de calories dans une cavité, un tissu ou un vaisseau, dont le chauffage est déporté à l'extrémité distale de ladite micro-résistance. En d'autres termes, la micro-résistance de l'invention ne présente qu'une zone de chauffage distale, ce qui permet d'éviter tout échauffement des tissus en dehors de cette zone. Plus précisément, l'invention a pour objet une micro-résistance en tout ou partie implantable destinée à l'administration de calories dans une cavité, un tissu ou un vaisseau se présentant sous la forme d'un tube métallique de résistivité Rl présentant des extrémités proximale et distale et enveloppant un matériau conducteur d'électricité (sous la forme d'un fil ou d'un tube) de résistivité R2 au moins 5 fois, avantageusement au moins 15 fois supérieure à Rl, ledit matériau conducteur d'électricité étant connecté à l'extrémité distale obturée du tube métallique de résistivité Rl par son extrémité terminale et présentant, en amont de ladite extrémité terminale deux portions distinctes, : une portion médiane et proximale recouverte : o d'une première couche d'un matériau conducteur d'électricité de résistivitéTo do this, the Applicant has managed to develop a micro-resistance in all or part implantable for the delivery of calories in a cavity, a tissue or a vessel, the heating of which is offset at the distal end of said micro-resistance. In other words, the micro-resistance of the invention has only a distal heating zone, which makes it possible to avoid any heating of the tissues outside this zone. More specifically, the subject of the invention is a micro-resistance in whole or in part implantable intended for the administration of calories in a cavity, a tissue or a vessel in the form of a resistivity metal tube R1 having ends proximal and distal and enveloping an electrically conductive material (in the form of a wire or a tube) of resistivity R2 at least 5 times, advantageously at least 15 times greater than R1, said electrically conductive material being connected at the distal closed end of the resistivity metal tube R1 at its end end and having, upstream of said terminal end, two distinct portions, a medial and proximal portion covered with: a first layer of a conductive material; resistivity electricity
R3 inférieure à R2 présentant des moyens de connexions à l'une des bornes d'un générateur de courant et assurant l'arrivée du courant ou vice et versa, o puis, d'une seconde couche isolante, une partie distale recouverte uniquement de ladite seconde couche isolante, le tube métallique de résistivité Rl présentant des moyens de connexions à l'autre borne du générateur de courant et assurant ainsi le retour du courant ou vice et versa. En pratique, le diamètre de la micro-résistance, lorsque celle-ci est implantée tel quel est compris entre 0.2 et 0.8 mm.R3 less than R2 having means for connection to one of the terminals of a current generator and ensuring the arrival of the current or vice versa, o then, a second insulating layer, a distal portion covered only with said second insulating layer, the resistivity metal tube Rl having connection means to the other terminal of the current generator and thus ensuring the return of the current or vice versa. In practice, the diameter of the micro-resistor, when it is implanted as such, is between 0.2 and 0.8 mm.
Par ailleurs, ladite « seconde couche isolante » est avantageusement résistante à une température de 2000C et fabriquée à partir d'un matériau choisi dans le groupe comprenant teflon®, polyimide et alumine.Moreover, said "second insulating layer" is advantageously resistant to a temperature of 200 ° C. and made from a material chosen from the group comprising teflon®, polyimide and alumina.
Dans la mesure où le matériau conducteur est enveloppé du tube métallique de résistivité Rl, la couche isolante se trouve emprisonnée dans le tube périphérique et ne risque pas de diffuser dans l'organisme en cas de craquelage.Insofar as the conductive material is wrapped with the resistivity metal tube R1, the insulating layer is trapped in the peripheral tube and is not likely to diffuse into the body in case of cracking.
En d'autres termes, le courant circule en pratique depuis le pôle + du générateur jusqu'au pôle - en passant successivement par la couche de résistivité R3 au niveau des parties proximale et médiane du matériau conducteur puis dans le matériau conducteur d'électricité de résistance R2 sur la portion distale. Le courant passe ensuite dans la paroi du tube métallique de résistivité Rl au niveau de l'extrémité terminale dépourvue de couche isolante, du matériau conducteur d'électricité de résistivité R2, pour revenir jusqu'au générateur.In other words, the current flows in practice from the + pole of the generator to the pole - passing successively by the resistivity layer R3 at the proximal and median portions of the conductive material and then in the electrically conductive material of R2 resistance on the distal portion. The current then passes into the wall of the resistivity metal tube R1 at the end end without insulating layer, the electrically conductive material resistivity R2, to return to the generator.
Dans la mesure où l'extrémité distale du matériau conducteur d'électricité présente une résistivité R2, au moins 5 fois supérieure à la résistivité R3, il s'ensuit un réchauffement de la micro -résistance exclusivement au niveau de la partie distale du tube, à une température en pratique d'environ 2000C.Insofar as the distal end of the electrically conductive material has a resistivity R2, at least 5 times greater than the resistivity R3, it follows a warming of the micro-resistance exclusively at the distal portion of the tube, at a temperature in practice of about 200 ° C.
Dans un mode de réalisation avantageux, la valeur de la résistivité Rl est sensiblement égale à la valeur de la résistivité R3.In an advantageous embodiment, the value of the resistivity R1 is substantially equal to the value of the resistivity R3.
Avantageusement et selon une autre caractéristique, le tube métallique de résistivité Rl et la première couche d'un matériau conducteur d'électricité de résistivité R3 sont réalisés en cuivre, notamment par dépôt électrolytique ou par sertissage, la résistivité du cuivre étant de 1,7 μΩcm. La couche de cuivre appliquée sur le matériau de résistivité R2 a, en pratique, une épaisseur comprise entre 10 et 40 microns, avantageusement de l'ordre de 30 microns.Advantageously and according to another characteristic, the resistivity metal tube R1 and the first layer of a resistivity-conducting electrically conductive material R3 are made of copper, in particular by electrolytic deposition or by crimping, the resistivity of the copper being 1.7 μΩcm. The copper layer applied to the resistivity material R2 has, in practice, a thickness of between 10 and 40 microns, advantageously of the order of 30 microns.
Avantageusement, et dans un premier mode de réalisation, le matériau conducteur d'électricité de résistivité R2 se présente sous la forme un fil de constantan, c'est-à-dire un alliage cuivre/ nickel dont la résistance est indépendante de la température ou d'un fil constitué d'un alliage nickel/chrome. En pratique, la résistivité du constantan est de 50 μΩcm tandis que l'alliage nickel/chrome à une résistivité de 110 μΩcm. Le constantan ou l'alliage nickel/chrome peut éventuellement être remplacé par de l'inox. Toutefois, le dépôt de cuivre sur l'inox reste délicat. Associé au tube métallique de résistivité Rl, réalisé en pratique en cuivre, le constantan ou l'alliage nickel/chrome confèrent à la micro-résistance une certaine souplesse. Pour rigidifier le système, le matériau conducteur d'électricité de résistivité R2 se présente non pas sous la forme d'un fil mais sous la forme d'un tube éventuellement obturé à sa partie distale et dans lequel est introduite une aiguille amovible en inox, conférant au système une certaine rigidité. Dans ce cas, le tube de constantan ou d'alliage nickel/chrome remplaçant le fil de constantan ou d'alliage nickel/chrome, revêtu des première et seconde couches isolantes telles que précédemment décrites, est mis en place dans le tube métallique de résistivité Rl. L'extrémité terminale du tube de matériau conducteur de résistivité R2 en contact avec l'extrémité distale du tube métallique de résistivité Rl est dépourvue de couche isolante autorisant ainsi le passage du courant d'un tube à l'autre.Advantageously, and in a first embodiment, the electrically conductive material of resistivity R2 is in the form of a constantan wire, that is to say a copper / nickel alloy whose resistance is independent of temperature or a wire made of a nickel / chromium alloy. In practice, the constantan resistivity is 50 μΩcm while the nickel / chromium alloy has a resistivity of 110 μΩcm. The constantan or the nickel / chromium alloy may possibly be replaced by stainless steel. However, the deposit of copper on the stainless steel remains delicate. Associated with the metal resistivity tube R1, made in practice of copper, the constantan or the nickel / chromium alloy gives the micro-resistance a certain flexibility. To stiffen the system, the electrically conductive material resistivity R2 is not in the form of a wire but in the form of a tube possibly closed at its distal portion and into which is introduced a removable stainless steel needle, conferring on the system a certain rigidity. In this case, the constantan or nickel / chromium alloy tube replacing the constantan or nickel / chromium alloy wire, coated with the first and second insulating layers as previously described, is placed in the metal resistivity tube. apply. The end end of the resistivity conductive material tube R2 in contact with the distal end of the resistivity metal tube R1 is devoid of an insulating layer thereby allowing the passage of the current from one tube to the other.
Comme déjà mentionné, la micro-résistance de l'invention telle qu'elle vient d'être décrite peut être utilisée telle quelle, c'est-à-dire sans apport d'eau externe, en particulier pour le traitement des varices selon un procédé qui sera décrit par la suite.As already mentioned, the micro-resistance of the invention as just described can be used as such, that is to say without external water supply, particularly for the treatment of varicose veins according to a process which will be described later.
Dans un second mode de réalisation, la micro -résistance de l'invention peut être utilisée comme moyen de chauffage destiné à vaporiser de l'eau apportée depuis l'extérieur de l'organisme, à l'instar des systèmes décrits dans l'état de la technique.In a second embodiment, the micro-resistance of the invention can be used as a heating means for vaporizing water brought from outside the body, like the systems described in the state. of the technique.
Dans cette hypothèse, l'objet de l'invention est un dispositif en toute ou partie implantable destiné à l'administration de vapeur d'eau dans un tissu ou vaisseau, qui se caractérise en ce que :In this hypothesis, the subject of the invention is a device that is wholly or partially implantable for the administration of water vapor in a tissue or vessel, which is characterized in that:
- il se présente sous la forme d'un tube périphérique constitué de parties distale, médiane et proximale, ledit tube contenant dans sa lumière, sur toute sa longueur, une micro-résistance du type de celle décrite précédemment, l'eau étant destinée à circuler dans l'espace mort séparant la paroi du tube de la micro-résistance, la partie proximale du tube présente une extrémité en Y, dont une sortie est destinée à être raccordée directement à une arrivée d'eau, et dont l'autre sortie est partiellement obturée pour permettre le passage des moyens de connexion de la micro-résistance aux bornes du générateur de courant.- It is in the form of a peripheral tube consisting of distal, medial and proximal parts, said tube containing in its light, throughout its length, a micro-resistance of the type described above, the water being intended for circulating in the dead space separating the wall of the tube from the micro-resistance, the proximal portion of the tube has a Y end, one outlet of which is intended to be connected directly to a water inlet, and the other of which is partially closed to allow passage of the connection means of the micro-resistance to the terminals of the current generator.
En d'autres termes, l'eau n'est plus chauffée par le biais de la paroi du tube, mais au moyen d'une résistance électrique incorporée dans la lumière du tube, à l'extrémité distale de celle-ci. De la sorte, le gradient de température se trouve inversé par rapport au système de l'art antérieur, c'est-à-dire qu'il diminue du centre vers la périphérie du tube et non le contraire. La seconde condition pour transformer l'eau en vapeur au moment de la libération reste donc son transfert au sein du tube sous forme pressurisée, ce qui est rendu possible par la mise en œuvre d'un volume restreint dans lequel l'eau circule. L'un des avantages de la solution nouvellement proposée est qu'il n'existe plus de contrainte dimensionnelle pour la réalisation du tube assurant le transfert de l'eau, puisqu'il suffit de définir un volume suffisamment restreint entre la paroi du tube et la micro-résistance centrale pour que l'eau se trouve à l'état pressurisée à l'extrémité distale du tube. La paroi atteint dès lors une température inférieure à celle de la vapeur d'eau, limitant ainsi l'effet du chauffage produit à un phénomène de thermonécrose ou de thermofibrose mais en aucun cas, à un phénomène de nécrose par chaleur sèche.In other words, the water is no longer heated through the wall of the tube, but by means of an electrical resistance incorporated in the tube lumen, at the distal end thereof. In this way, the temperature gradient is reversed compared to the system of the prior art, that is to say that it decreases from the center to the periphery of the tube and not the opposite. The second condition for transforming water into steam at the time of release thus remains its transfer into the tube in pressurized form, which is made possible by the implementation of a restricted volume in which the water circulates. One of the advantages of the newly proposed solution is that there is no longer any dimensional constraint for the realization of the tube ensuring the transfer of water, since it is sufficient to defining a sufficiently small volume between the wall of the tube and the central micro-resistance so that the water is in the pressurized state at the distal end of the tube. The wall therefore reaches a temperature lower than that of the water vapor, thus limiting the effect of the heating produced to a phenomenon of thermonecrosis or thermofibrosis but in no case to a necrosis phenomenon by dry heat.
Autrement dit, la différence de résistivité entre le tube périphérique enveloppant la microrésistance (au niveau de sa partie distale) et la microrésitance proprement dite étant très élevée, ceci permet de chauffer de manière sélective le liquide sous forme pressurisée, exclusivement au niveau de l'extrémité distale du tube.In other words, the difference in resistivity between the peripheral tube enveloping the micro-resistance (at its distal portion) and the microresistance itself being very high, this makes it possible to selectively heat the liquid in pressurized form, exclusively at the level of the distal end of the tube.
Selon une première caractéristique, la différence de diamètre entre le diamètre interne du tube et le diamètre de la micro-résistance est compris entre 50 et 100 μm. En pratique, le diamètre externe du tube est compris entre 0.3 et 1 mm, et le diamètre interne est compris entre 0.2 et 0.8 mm. Le fait de pouvoir mettre en œuvre des micro -résistances de diamètre proche de 0.8 mm, tout en conservant un espace mort réduit, permet de générer une surface de chauffage plus importante, améliorant le transfert de calories. Il est ainsi possible de réduire la longueur de la micro-résistance dans sa partie distale, ce qui permet de concentrer le chauffage dans la zone à traiter.According to a first feature, the difference in diameter between the internal diameter of the tube and the diameter of the micro-resistance is between 50 and 100 microns. In practice, the outer diameter of the tube is between 0.3 and 1 mm, and the internal diameter is between 0.2 and 0.8 mm. The fact of being able to implement microresistances of diameter close to 0.8 mm, while maintaining a reduced dead space, makes it possible to generate a larger heating surface, improving the transfer of calories. It is thus possible to reduce the length of the micro-resistor in its distal part, which makes it possible to concentrate the heating in the zone to be treated.
Le tube périphérique se décompose en trois parties distinctes respectivement une partie distale, une partie médiane et une partie proximale.The peripheral tube is divided into three distinct parts respectively a distal portion, a medial portion and a proximal portion.
Comme indiqué précédemment, la micro -résistance reste relativement souple du fait de sa structure associant, avantageusement, cuivre et constantan ou nickel/chrome. Pour rigidifier le système, les parties distale et médiane du tube périphérique peuvent se présenter sous la forme d'une aiguille, avantageusement choisie en inox.As indicated above, the micro-resistance remains relatively flexible because of its structure associating, advantageously, copper and constantan or nickel / chromium. To stiffen the system, the distal and median portions of the peripheral tube may be in the form of a needle, preferably selected from stainless steel.
Lorsqu'on améliore la rigidité par mise en oeuvre d'une aiguille dans un tube de constantan ou de nickel/chrome en lieu et place d'un fil de constantan ou nickel/chrome, le tube périphérique peut se présenter sous la forme d'un cathéter. Dans cette hypothèse, les parties distale et médiane sont réalisées en un matériau choisi dans le groupe comprenant le PEEK, le PTFE et le polyphénylsulfone ou d'un alliage super souple du type nickel/titane commercialisé sous la marque Ritinol®.When the rigidity is improved by using a needle in a constantan or nickel / chromium tube instead of a constantan or nickel / chromium wire, the peripheral tube may be in the form of a catheter. In this case, the distal and medial parts are made of a material selected from the group comprising PEEK, PTFE and polyphenylsulfone or a super-soft alloy of the nickel / titanium type marketed under the trade name Ritinol®.
La partie distale du tube périphérique peut être débouchante ou obturée. Dans ce second cas, elle est munie latéralement de perforations de taille de comprise entre 50 μm et 150 μm, avantageusement égale à 70 μm.The distal portion of the peripheral tube may be open or closed. In this second case, it is laterally provided with perforations having a size of between 50 μm and 150 μm, advantageously equal to 70 μm.
Concernant la partie proximale, celle-ci peut être réalisée dans un matériau souple, tel que par exemple du silicone, la jonction entre la partie silicone et l'aiguille ou le cathéter étant effectuée par tout moyen de connexion connu de l'homme du métier, et en particulier par vissage ou collage.As regards the proximal part, this may be made of a flexible material, such as, for example, silicone, the junction between the silicone part and the needle or the catheter being performed by any connection means known to those skilled in the art, and in particular by screwing or gluing.
Dans la pratique, cette connexion est sécurisée par la mise en place d'un manchon de préhension recouvrant la jonction entre la partie médiane et la partie proximale du tube.In practice, this connection is secured by the establishment of a gripping sleeve covering the junction between the middle portion and the proximal portion of the tube.
La partie proximale se présente sous la forme d'une pièce en Y, dont une sortie est connectée de manière étanche, par exemple au moyen d'un luer, à une alimentation d'eau et dont l'autre sortie est isolée électriquement et partiellement obturée pour permettre le passage des moyens de connexion de la micro-résistance aux bornes du générateur de courant.The proximal portion is in the form of a Y-shaped part, an outlet of which is connected sealingly, for example by means of a luer, to a water supply and the other outlet is electrically isolated and partially closed to allow passage of the connection means of the micro-resistance to the terminals of the current generator.
Le dispositif tel qu'il vient d'être décrit présente en outre l'avantage d'être peu coûteux en termes de fabrication. Dès lors, il s'agit d'un dispositif consommable permettant ainsi de supprimer totalement le problème de contamination.The device as just described has the further advantage of being inexpensive in terms of manufacturing. Therefore, it is a consumable device and thus completely eliminate the problem of contamination.
Comme déjà dit, le dispositif peut être utilisé pour le traitement des tumeurs en insérant la micro -résistance associée ou non à un cathéter ou une aiguille périphériques directement dans le tissu. Ceci est fonction de la teneur de la tumeur en eau, étant rappelé que si cette teneur est suffisante, la micro -résistance à elle seule permet de chauffer l'eau contenue dans la tumeur à une température voisine de 95°C. De la même façon, le dispositif peut être également mis en oeuvre par voie endoluminale, pour le traitement d'autres pathologies, telles que par exemple le traitement des varices. L'ensemble de ces techniques est décrit dans les documents précités du Demandeur.As already said, the device can be used for the treatment of tumors by inserting the micro-resistance associated or not with a peripheral catheter or needle directly into the tissue. This is a function of the content of the tumor in water, being reminded that if this content is sufficient, micro-resistance alone can heat the water contained in the tumor at a temperature of about 95 ° C. In the same way, the device can also be used endoluminally, for the treatment of other pathologies, such as for example the treatment of varicose veins. All of these techniques are described in the aforementioned documents of the Applicant.
L'invention a donc également pour objet un procédé de traitement des tumeurs par administration de calories consistant : à inciser la peau, puis à introduire dans le tissu cible les parties distale et médiane de la micro- résistance ou du dispositif (microrésistance + tube périphérique), puis, à alimenter la micro-résistance en électricité et le cas échéant simultanément, et en continu, le tube en eau, de manière à chauffer l'eau en la maintenant à l'état pressurisé au niveau de l'extrémité distale du tube avant injection dans le tissu, à retirer le dispositif en fin de traitement.The invention therefore also relates to a method for treating tumors by administering calories comprising: incising the skin and then introducing into the target tissue the distal and medial portions of the micro-resistance or the device (microresistance + peripheral tube ), then, supplying the micro-resistance with electricity and if necessary simultaneously and continuously, the tube with water, so as to heat the water by maintaining it in the pressurized state at the distal end of the tube before injection into the tissue, remove the device at the end of treatment.
Lorsque la micro-résistance est utilisée en combinaison avec un tube périphérique, les parties distale et médiane dudit tube se présentent sous la forme d'une aiguille, l'aiguille est piquée directement dans le tissu à traiter.When the micro-resistance is used in combination with a peripheral tube, the distal and middle portions of said tube are in the form of a needle, the needle is directly stitched into the tissue to be treated.
Lorsque les parties distale et médiane dudit tube se présentent sous la forme d'un cathéter, celui-ci est introduit directement dans l'organisme, la rigidité du cathéter étant obtenue par la mise en oeuvre d'un tube de constantan ou de nickel/chrome muni d'une tige en inox amovible, en lieu et place du fil de constantan ou de nickel/chrome.When the distal and median portions of said tube are in the form of a catheter, it is introduced directly into the body, the rigidity of the catheter being obtained by the implementation of a tube of constantan or nickel / chrome provided with a removable stainless steel rod, instead of constantan wire or nickel / chrome.
L'invention a également pour objet un procédé de traitement des pathologies artérioveineuses par injection de calories par voie endoluminale dans les vaisseaux, consistant :The invention also relates to a method for treating arteriovenous pathologies by injecting endoluminal calories into the vessels, consisting of:
- à inciser la peau, puis à introduire dans les vaisseaux les parties distale et médiane de la microrésistance ou du dispositif (microrésistance + tube périphérique), - puis, à alimenter la micro-résistance en électricité et le cas échéant simultanément, et en continu, le tube en eau, de manière à chauffer l'eau en la maintenant à l'état pressurisé au niveau de l'extrémité distale du tube avant injection dans les vaisseaux, à retirer le dispositif en fin de traitement.- To incise the skin, then to introduce in the vessels the distal and medial parts of the micro-resistance or the device (micro-resistance + peripheral tube), - then, to feed the micro-resistance in electricity and if necessary simultaneously, and continuously , the tube in water, so as to heat the water by maintaining it in the pressurized state at the distal end of the tube before injection into the vessels, to remove the device at the end of treatment.
Dans un mode de réalisation particulier, l'invention a pour objet un procédé de traitement des varices par injection de calories par voie endoluminale, sous anesthésie locale ou générale, consistant : à effectuer un repérage de la veine à traiter, par marquage sur la peau du cheminement de la veine et de l'orifice d'introduction du dispositif,In a particular embodiment, the subject of the invention is a method for treating varicose veins by endoluminal injection of calories, under local or general anesthesia, consisting in: performing a tracing of the vein to be treated, by marking on the skin the path of the vein and the introduction orifice of the device,
- à inciser la peau, puis à introduire dans la veine à traiter les parties distale et médiane de la microrésistance ou du dispositif (microrésistance + tube périphérique), puis, à alimenter la micro-résistance en électricité et le cas échéant simultanément, et en continu, le tube en eau, de manière à chauffer l'eau en la maintenant à l'état pressurisé au niveau de l'extrémité distale du tube avant injection dans la veine, à retirer progressivement le dispositif.to incise the skin, then to introduce into the vein to treat the distal and medial portions of the micro-resistance or the device (microresistance + peripheral tube), then, to supply the micro-resistance with electricity and if necessary simultaneously, and continuously, the tube in water, so as to heat the water by maintaining it in the pressurized state at the distal end of the tube before injection into the vein, to gradually remove the device.
L'invention a également pour objet, dans le cas particulier où il y a injection de vapeur d'eau, une installation pour la mise en œuvre dudit procédé de traitement des varices par voie endoluminale, comprenant le dispositif précédemment décrit dont l'extrémité en Y de la partie proximale est raccordée par sa première branche à un système d'injection d'eau et par sa seconde branche à une source de courant.The subject of the invention is also, in the particular case where there is water vapor injection, an installation for implementing said endoluminal variceal treatment method, comprising the device previously described, the end of which is Y of the proximal part is connected by its first branch to a water injection system and by its second branch to a current source.
Dans un mode de réalisation avantageux, le système d'injection d'eau se présente sous la forme d'un tube souple directement connecté de manière étanche sur le Y, le tube étant comprimé, au niveau de son extrémité proximale, entre deux rouleaux fixes mus en rotation à la même vitesse au moyen d'un moteur, dans la direction opposée à celle de la veine à traiter. Le mouvement des rouleaux entraîne ainsi l'injection de l'eau proprement dite dans le dispositif de l'invention et simultanément le recul régulier et donc le retrait du dispositif de la veine. Le présent dispositif peut par ailleurs également être adapté pour éliminer les excès de graisses par la technique dite de « liposuccion ».In an advantageous embodiment, the water injection system is in the form of a flexible tube directly sealingly connected to the Y, the tube being compressed, at its proximal end, between two fixed rollers. rotated at the same speed by means of a motor, in the opposite direction to that of the vein to be treated. The movement of the rollers thus causes the injection of the actual water into the device of the invention and simultaneously the regular retreat and thus the removal of the device from the vein. The present device can also be adapted to eliminate excess fat by the so-called "liposuction" technique.
Actuellement, la réduction de cellulite peut être obtenue essentiellement par deux méthodes.Currently, cellulite reduction can be achieved essentially by two methods.
La première consiste à introduire, par voie sous-cutanée, une canule dont l'extrémité distale est munie d'un système ultrasons ayant pour fonction de casser la membrane des adipocytes. Ce dispositif présente l'inconvénient essentiel d'être très onéreux puisque fabriqué à partir de matériaux non consommables. Il s'ensuit des risques potentiels de contamination.The first is to introduce, subcutaneously, a cannula whose distal end is provided with an ultrasound system whose function is to break the membrane of adipocytes. This device has the essential disadvantage of being very expensive since manufactured from non-consumable materials. This leads to potential risks of contamination.
Une autre technique consiste à traiter la cellulite en détruisant les adipocytes par la chaleur au moyen d'un faisceau laser. Cette technique présente le principal inconvénient de générer une chaleur ponctuelle pouvant entraîner une nécrose des tissus par chaleur sèche.Another technique consists in treating cellulite by destroying the adipocytes by heat by means of a laser beam. This technique has the main disadvantage of generating a point heat that can cause tissue necrosis by dry heat.
Le Demandeur a constaté que son dispositif pouvait être utilisé pour réduire la cellulite moyennant quelques adaptations, en prévoyant notamment une gaine périphérique munie de perforations latérales agencées autour du tube au moins dans sa partie distale et reliée à un système d'aspiration.The Applicant has found that its device could be used to reduce cellulite with some adaptations, including providing a peripheral sheath provided with lateral perforations arranged around the tube at least in its distal portion and connected to a suction system.
L'avantage du traitement de la cellulite par injection de vapeur permet d'assurer, par rapport aux autres techniques, un effet complémentaire de thermofibrose, c'est-à-dire la rétraction des fibres de collagène (chauffage à 85°C pendant au moins 15 secondes) permettant ainsi de retendre la peau. De plus, il n'y a pas de risque de nécrose des tissus sous-cutanés par chaleur sèche.The advantage of the treatment of cellulite by steam injection makes it possible, compared to the other techniques, to provide a complementary effect of thermofibrosis, that is to say the retraction of the collagen fibers (heating at 85.degree. minus 15 seconds) thus allowing to retension the skin. In addition, there is no risk of necrosis of the subcutaneous tissue by dry heat.
En d'autres termes, l'invention a également pour objet une méthode visant à éliminer les excès graisseux du corps humain mettant en œuvre le dispositif précédemment décrit.In other words, the invention also relates to a method for removing excess fat from the human body implementing the device described above.
Plus précisément, la méthode consiste : - à inciser la peau, puis à introduire par voie sous-cutanée dans le tissu adipeux les parties distale et médiane du dispositif (microrésistance + tube périphérique), puis, simultanément, et en continu, à alimenter le tube en eau et le moyen de chauffage en électricité, de manière à chauffer l'eau en la maintenant à l'état pressurisé au niveau de l'extrémité distale du tube avant injection dans le tissu, à aspirer les adipocytes détruits par la vapeur d'eau, - à retirer le dispositif en fin de traitement. L'invention et les avantages qui en découlent ressortiront mieux des exemples de réalisation suivants, à l'appui des figures annexées.More precisely, the method consists in: - incising the skin, then introducing subcutaneously into the adipose tissue the distal and medial parts of the device (microresistance + peripheral tube), then, simultaneously, and continuously, feeding the tube in water and means of heating electricity, so as to heat the water by maintaining it in the pressurized state at the distal end of the tube before injection into the tissue, to suck the fat cells destroyed by the steam water, - remove the device at the end of treatment. The invention and the advantages which result therefrom will emerge more clearly from the following exemplary embodiments, in support of the appended figures.
La figure 1 est une représentation schématique en coupe d'un dispositif de l'invention utilisé directement dans les tissus ou par voie endoluminale.Figure 1 is a schematic sectional representation of a device of the invention used directly in tissues or endoluminally.
La figure 2 est une représentation schématique en coupe du dispositif de l'invention adapté pour l'élimination des excès de graisses.Figure 2 is a schematic sectional representation of the device of the invention adapted for the removal of excess fat.
La figure 3 est une représentation détaillée en coupe de la microrésistance de l'invention selon un premier mode de réalisation. La figure 4 est une représentation détaillée en coupe de la micro-résistance selon un second mode de réalisation.Figure 3 is a detailed sectional representation of the microresistor of the invention according to a first embodiment. Figure 4 is a detailed sectional representation of the micro-resistor according to a second embodiment.
La figure 5 est une représentation schématique d'une installation destinée au traitement des varices.Figure 5 is a schematic representation of an installation for treating varicose veins.
Selon les figures 1 et 2, le dispositif de l'invention est constitué d'un tube périphérique (1) que l'on peut diviser en deux parties, respectivement : des parties distale et médiane implantable (2), et une partie non implantée (3) correspondant à la partie proximale du dispositif.According to FIGS. 1 and 2, the device of the invention consists of a peripheral tube (1) which can be divided into two parts, respectively: distal and medial implantable parts (2), and a non-implanted part (3) corresponding to the proximal portion of the device.
Sur la figure 1, la partie implantable se présente sous la forme d'une aiguille biseautée réalisée en inox dont le diamètre interne est par exemple égal à 0.8 mm tandis que le diamètre externe est de 1 mm. Bien entendu et comme déjà dit, cette aiguille peut être remplacée par un cathéter de dimensions équivalentes réalisé par exemple en PEEK. Cette partie implantable est connectée à la partie proximale (3) non implantée de manière étanche par exemple par collage (4). La partie non implantée se présente quant à elle sous la forme d'un Y, réalisé en silicone, dont l'une des branches (5) est destinée à être raccordée à une arrivée d'eau (6), et dont l'autre branche (7) est partiellement obturée pour permettre le passage des moyens de connexion (8) de la microrésistance (9) aux bornes du générateur de courant (10).In Figure 1, the implantable portion is in the form of a beveled needle made of stainless steel whose internal diameter is for example equal to 0.8 mm while the outer diameter is 1 mm. Of course and as already said, this needle can be replaced by a catheter of equivalent dimensions made for example PEEK. This implantable portion is connected to the proximal portion (3) not implanted sealingly for example by gluing (4). The non-implanted portion is in the form of a Y, made of silicone, one of the branches (5) is intended to be connected to a water inlet (6), and the other branch (7) is partially closed to allow passage of the connection means (8) of the microresistor (9) to the terminals of the current generator (10).
Pour faciliter la préhension du dispositif, ledit dispositif est muni d'un manchon (11) en silicone recouvrant le tube (1) au niveau de la jonction des parties médiane et proximale.To facilitate the gripping of the device, said device is provided with a sleeve (11) of silicone covering the tube (1) at the junction of the medial and proximal parts.
Selon une caractéristique essentielle, le tube périphérique (1) comporte, dans sa lumière, une microrésitance désignée par la référence générale (9) dont l'extrémité distale est alignée sur l'extrémité distale du tube périphérique. Dans un mode de réalisation non représenté, l'extrémité distale de la microrésistance présente une forme arrondie et s'étend au delà de l'extrémité distale du tube périphérique. Ce mode de réalisation est plus particulièrement approprié au traitement des varices car il convient de ne pas altérer la paroi de la veine à traiter par une extrémité anguleuse. La microrésistance présente, dans cet exemple, un diamètre externe de 0,75 mm laissant ainsi un espace mort réduit de 50 μm entre ladite microrésistance (9) et la surface interne du tube (1).According to an essential characteristic, the peripheral tube (1) comprises, in its light, a microresistor designated by the general reference (9), the distal end of which is aligned with the distal end of the peripheral tube. In an embodiment not shown, the distal end of the microresistor has a rounded shape and extends beyond the distal end of the peripheral tube. This embodiment is more particularly suitable for the treatment of varicose veins because it is necessary not to alter the wall of the vein to be treated by an angular end. The micro-resistance presents, in this example, an outer diameter of 0.75 mm leaving a reduced dead space of 50 microns between said microresistor (9) and the inner surface of the tube (1).
On a représenté sur la figure 3 la microrésistance (9) de l'invention.FIG. 3 shows the microresistor (9) of the invention.
Pour l'essentiel, cette microrésistance se présente sous la forme d'un tube formant enveloppe (11) réalisé en cuivre, de diamètre de 0,750 mm. Le cuivre constitutif du tube présente une résistivité Rl de 1,7 μΩcm.Essentially, this micro-resistance is in the form of a casing tube (11) made of copper, with a diameter of 0.750 mm. The constituent copper of the tube has a resistivity R1 of 1.7 μΩcm.
Le tube (11) contient dans sa lumière un fil conducteur de courant (12), dont l'extrémité terminale (13') de la portion distale (13) est connectée par soudure laser ou sertissage à l'extrémité distale (14) du tube (11). Ce fil est un fil de constantan, de diamètre égal à 0,3 mm ou un fil d'un alliage nickel/chrome de diamètre égal à 0,26 mm présentant deux portions distinctes.The tube (11) contains in its lumen a current-conducting wire (12), whose end end (13 ') of the distal portion (13) is connected by laser welding or crimping to the distal end (14) of the tube (11). This wire is a constantan wire, with a diameter of 0.3 mm or a wire of a nickel / chromium alloy with a diameter of 0.26 mm having two distinct portions.
Ainsi, les portions médiane et proximale du fil (12) sont recouvertes d'une première couche de cuivre électrolytique (15) d'une épaisseur de 30 μm, puis d'une seconde couche (16) d'un isolant électrique. A son extrémité distale, le fil de constantan est dépourvu de revêtement de cuivre électrolytique (15), mais est en revanche isolé électriquement (16) à l'exception de l'extrémité terminale proprement dite, laquelle est sertie ou soudée au tube de résistivité Rl .Thus, the medial and proximal portions of the wire (12) are covered with a first layer of electrolytic copper (15) of a thickness of 30 microns, then a second layer (16) of an electrical insulator. At its distal end, the constantan wire is free of electrolytic copper coating (15), but is electrically insulated (16) with the exception of the terminal end itself, which is crimped or soldered to the resistivity tube. Rl.
Comme représenté schématiquement sur la figure 3, le revêtement de cuivre (15) appliqué sur le fil (12) est relié (8) à la borne + du générateur de courant (10) tandis que le tube enveloppant périphérique (11) est relié (8) à la borne - du même générateur (10). De la sorte, le courant électrique chemine jusqu'à l'extrémité distale de la microrésistance dans le revêtement de cuivre (15) appliqué autour du fil. A proximité de l'extrémité du tube, l'électricité passe dans la partie distale du fil de (12) pour retourner ensuite au générateur (10) en cheminant dans la paroi du tube périphérique (11).As shown diagrammatically in FIG. 3, the copper coating (15) applied to the wire (12) is connected (8) to the + terminal of the current generator (10) while the peripheral wrapping tube (11) is connected ( 8) to the - terminal of the same generator (10). In this way, the electric current flows to the distal end of the microresistor in the copper coating (15) applied around the wire. Near the end of the tube, the electricity passes into the distal portion of the wire (12) to return thereafter to the generator (10) while traveling in the wall of the peripheral tube (11).
La présence d'un revêtement de cuivre (15) appliqué sur les parties médiane et proximale du fil (12) permet d'éviter le réchauffement du tube enveloppant (11) sur toute la longueur du dispositif (du fait de la différence de résistivité entre le fil et le cuivre constitutif du tube enveloppant). En pratique, la résistivité du fil de constantan R2 est d'environ 50 μΩcm ou du fil d'alliage nickel/chrome est d'environ 110 μΩcm, tandis que la résistivité du cuivre électrolytique R3 est de l'ordre de 1,7 Ωcm. Cette différence de résistivité permet le chauffage de l'eau circulant entre la paroi interne du tube du dispositif et la paroi externe du tube enveloppant, exclusivement au niveau de la partie distale de la microrésistance (9), à une valeur d'environ 4000C. A cette température, l'eau entraîne un chauffage de la paroi du tube (1) à une température inférieure à 2000C. Sur la figure 4, on a représenté un autre mode de réalisation de la microrésistance plus particulièrement adapté au cas dans lequel la partie implantable se présente sous la forme d'un cathéter souple (20). Le principe est de compenser la souplesse du cathéter ajoutée à celle de la microrésistance, en mettant en œuvre le constantan ou l'alliage nickel/chrome non plus sous la forme d'un fil mais sous la forme d'un tube creux (25) dans lequel est insérée de manière amovible une tige inox (21). En pratique, la tige en inox est retirée une fois le tube implanté.The presence of a copper coating (15) applied to the medial and proximal portions of the wire (12) prevents heating of the wrapping tube (11) over the entire length of the device (due to the difference in resistivity between the wire and the constituent copper of the enveloping tube). In practice, the resistivity of the constantan wire R2 is about 50 μΩcm or the nickel / chromium alloy wire is about 110 μΩcm, while the resistivity of the electrolytic copper R3 is of the order of 1.7 Ωcm . This difference in resistivity allows heating of the water circulating between the inner wall of the tube of the device and the outer wall of the wrapping tube, exclusively at the distal portion of the microresistor (9), to a value of approximately 400 ° C. C. At this temperature, the water causes the wall of the tube (1) to be heated at a temperature below 200 ° C. FIG. 4 shows another embodiment of the microresistor more particularly adapted to the case in which the implantable portion is in the form of a flexible catheter (20). The principle is to compensate for the flexibility of the catheter added to that of the micro-resistance, by implementing the constantan or the nickel / chromium alloy not in the form of a wire but in the form of a hollow tube (25). in which is inserted removably a stainless steel rod (21). In practice, the stainless steel rod is removed once the implanted tube.
Le dispositif de l'invention peut être implanté directement dans les tissus ou dans les vaisseaux par voie endoluminale.The device of the invention can be implanted directly into the tissues or vessels endoluminally.
Suivant les cas, l'aiguille ou le cathéter implantable sont insérés dans l'organisme pour atteindre la tumeur ou le vaisseau à traiter. Dans certains cas, la microrésistance est introduite seule, sans tube périphérique.Depending on the case, the needle or the implantable catheter are inserted into the body to reach the tumor or the vessel to be treated. In some cases, the micro-resistance is introduced alone, without peripheral tube.
Dans une deuxième étape, le générateur de courant est actionné de manière à faire cheminer le courant dans la microrésistance. Concomitamment, l'eau est injectée dans l'espace mort de taille réduite, permettant ainsi de chauffer l'eau progressivement pour atteindre au niveau de l'extrémité distale, une température de 2000C, l'eau étant alors sous forme pressurisée, c'est-à-dire liquide à une température supérieure à 1000C. L'eau, dans cette zone, étant à une température d'environ 2000C, est propulsée en continu ou en discontinu à l'extérieur du cathéter ou de l'aiguille par son extrémité distale débouchante, et se transforme immédiatement en vapeur après libération.In a second step, the current generator is actuated so as to route the current in the microresistor. At the same time, the water is injected into the reduced dead space, thus making it possible to heat the water gradually to reach, at the distal end, a temperature of 200 ° C., the water then being in pressurized form, that is to say liquid at a temperature above 100 ° C. The water, in this zone, being at a temperature of about 200 ° C., is propelled continuously or discontinuously outside the catheter or of the needle through its open distal end, and immediately turns into vapor after release.
Dans un mode de réalisation particulier, représenté sur la figure 2, le dispositif est adapté pour permettre son utilisation pour l'extraction de graisses, et en particulier de cellulite. Cette technique, connue sous le terme de "liposuccion", peut être avantageusement mise en œuvre par le biais du dispositif de l'invention lorsque celui-ci est recouvert, à sa périphérie, d'une gaine (17) reliée à un système d'aspiration (18) des adipocytes, la gaine étant pourvue d'un certain nombre de perforations latérales (19).In a particular embodiment, shown in Figure 2, the device is adapted to allow its use for the extraction of grease, and in particular cellulite. This technique, known by the term "liposuction", may advantageously be implemented by means of the device of the invention when it is covered, at its periphery, with a sheath (17) connected to a vacuum system. suction (18) of the adipocytes, the sheath being provided with a number of lateral perforations (19).
Après avoir procédé à une incision de la peau, le tube implantable qui, en pratique, a une longueur d'environ 30 cm, est introduit dans le tissu sous-cutané adipeux, la microrésistance est alors alimentée en courant de manière à chauffer le tube enveloppant au niveau de son extrémité distale. Parallèlement, l'eau est propulsée dans l'espace mort puis chauffée et pressurisée au niveau de l'extrémité distale. A la sortie, l'eau est transformée en vapeur et permet non seulement la suppression des adipocytes, mais également la thermofibrose, c'est-à-dire la rétraction du collagène. Simultanément, les excès de graisses sont aspirés dans la gaine grâce au moyen d'aspiration. Dans un mode de réalisation particulier, représenté sur la figure 5, le dispositif de l'invention est combiné avec un système spécifique d'injection d'eau, dans le cadre du traitement des varices.After making an incision of the skin, the implantable tube which, in practice, has a length of about 30 cm, is introduced into the subcutaneous adipose tissue, the microresistance is then supplied with current so as to heat the tube enveloping at its distal end. At the same time, the water is propelled into the dead space and then heated and pressurized at the distal end. At the outlet, the water is transformed into vapor and allows not only the removal of adipocytes, but also thermofibrosis, that is to say the retraction of collagen. At the same time, the excess fat is sucked into the sheath by suction means. In a particular embodiment, shown in Figure 5, the device of the invention is combined with a specific system of water injection, in the context of treatment varicose veins.
Selon ce schéma, le dispositif de l'invention désigné par la référence générale (1) est raccordé à son extrémité proximale à une système d'injection d'eau se présentant sous la forme d'une tube souple (22), pressé entre deux rouleaux (23.24), lesdits rouleau étant mus en rotation autour de leur axe, à vitesse identique, au moyen d'un moteur non représenté. En pratique, la taille et le volume du tube souple sont déterminés pour contenir la totalité du volume d'eau nécessaire au traitement de la veine visée. Le mouvement des rouleaux entraîne ainsi l'injection de l'eau proprement dite dans le dispositif de l'invention et simultanément le recul régulier et donc le retrait du dispositif de la veine.According to this diagram, the device of the invention designated by the general reference (1) is connected at its proximal end to a water injection system in the form of a flexible tube (22), pressed between two rollers (23.24), said roll being rotated about their axis, at identical speed, by means of a motor not shown. In practice, the size and the volume of the flexible tube are determined to contain the entire volume of water necessary for the treatment of the targeted vein. The movement of the rollers thus causes the injection of the actual water into the device of the invention and simultaneously the regular retreat and thus the removal of the device from the vein.
L'invention et les avantages qui en découlent ressortent bien de la description qui précède.The invention and the advantages derived therefrom are apparent from the foregoing description.
On note en particulier la mise en œuvre d'un système évitant tout risque de nécrose des tissus ou des vaisseaux par chaleur sèche, que le sytème soit constitué uniquement de la microrésistance ou de la combinaison microrésitance + tube périphérique.In particular, the implementation of a system avoiding any risk of necrosis of tissues or vessels by dry heat, that the system consists solely of microresistance or combination microresistance + peripheral tube.
Un autre avantage de l'invention reste le faible coût qui peut déboucher sur la commercialisation d'un dispositif consommable, évitant ainsi tout risque d'infection que l'on connaît avec les moyens mis en œuvre actuellement sur le marché. Another advantage of the invention remains the low cost that can lead to the marketing of a consumable device, thus avoiding any risk of infection that is known with the means currently implemented on the market.

Claims

REVENDICATIONS
1/ Micro-résistance (9) en tout ou partie implantable destinée à l'administration de calories dans une cavité, un tissu ou un vaisseau se présentant sous la forme d'un tube métallique de résistivité Rl (11) présentant des extrémités proximale et distale et enveloppant un matériau conducteur d'électricité de résistivité R2 (12) au moins 5 fois supérieure à Rl, ledit matériau conducteur d'électricité (12) étant connecté à l'extrémité distale obturée (14) du tube métallique de résistivité Rl (11) par son extrémité terminale et présentant, en amont de ladite extrémité terminale deux portions distinctes : - une portion médiane et proximale recouverte : o d'une première couche (15) d'un matériau conducteur d'électricité de résistivité R3 inférieure à R2 présentant des moyens de connexions à l'une des bornes du générateur de courant (10) et assurant l'arrivée du courant ou vice et versa, o puis, d'une seconde couche isolante, une partie distale recouverte uniquement d'une couche isolante (16), le tube métallique de résistivité Rl (11) présentant des moyens de connexions à l'autre borne du générateur de courant (10) et assurant ainsi le retour du courant ou vice et versa.1/ Micro-resistance (9) in whole or in part implantable intended for the administration of calories in a cavity, a tissue or a vessel in the form of a metal tube of resistivity Rl (11) having proximal ends and distal and enveloping an electrically conductive material of resistivity R2 (12) at least 5 times greater than Rl, said electrically conductive material (12) being connected to the closed distal end (14) of the metal tube of resistivity Rl ( 11) by its terminal end and having, upstream of said terminal end, two distinct portions: - a middle and proximal portion covered: o with a first layer (15) of an electrically conductive material of resistivity R3 less than R2 having means of connection to one of the terminals of the current generator (10) and ensuring the arrival of the current or vice versa, o then, a second insulating layer, a distal part covered only with an insulating layer (16), the metal tube of resistivity Rl (11) presenting connection means to the other terminal of the current generator (10) and thus ensuring the return of the current or vice and versa.
2/ Micro-résistance selon la revendication 1, caractérisée en ce que Rl est sensiblement égale à R3.2/ Micro-resistance according to claim 1, characterized in that Rl is substantially equal to R3.
3/ Micro-résistance selon la revendication 1, caractérisée en ce qu'elle a un diamètre comprise entre 0,2 et 0,8 mm.3/ Micro-resistance according to claim 1, characterized in that it has a diameter of between 0.2 and 0.8 mm.
4/ Micro-résistance selon la revendication 1, caractérisée en ce que tube métallique de résistivité Rl et la première couche d'un matériau conducteur d'électricité de résistivité R3 sont réalisés en cuivre.4/ Micro-resistor according to claim 1, characterized in that that metal tube of resistivity Rl and the first layer of an electrically conductive material of resistivity R3 are made of copper.
5/ Micro-résistance selon la revendication 1, caractérisée en ce que le matériau conducteur d'électricité de résistivité R2 se présente sous la forme d'un fil de constantan ou d'un alliage nickel/chrome (12) ou d'un tube de constantan ou d'un alliage nickel/chrome (25) dans lequel est introduite une tige amovible (21).5/ Micro-resistor according to claim 1, characterized in that the electrically conductive material of resistivity R2 is in the form of a constantan wire or a nickel/chromium alloy (12) or a tube of constantan or a nickel/chromium alloy (25) into which a removable rod (21) is introduced.
6/ Dispositif en toute ou partie implantable destiné à l'administration de vapeur d'eau dans un tissu ou vaisseau, qui se caractérise en ce que : il se présente sous la forme d'un tube périphérique (1) constitué de parties distale (2), médiane (2) et proximale (3), ledit tube (1) contenant dans sa lumière, sur toute sa longueur, la micro-résistance objet de l'une des revendications 1-5, l'eau étant destinée à circuler dans l'espace mort séparant la paroi du tube (1) de la micro -résistance (9), la partie proximale (3) du tube présente une extrémité en Y, dont une sortie (5) est destinée à être raccordée directement à une arrivée d'eau (6), et dont l'autre sortie6/ Device in whole or in part implantable intended for the administration of water vapor into a tissue or vessel, which is characterized in that: it is in the form of a peripheral tube (1) made up of distal parts ( 2), median (2) and proximal (3), said tube (1) containing in its lumen, over its entire length, the micro-resistance object of one of claims 1-5, the water being intended to circulate in the dead space separating the wall of the tube (1) from the micro-resistance (9), the proximal part (3) of the tube has a Y-shaped end, one outlet (5) of which is intended to be connected directly to a water inlet (6), and the other outlet of which
(7) est partiellement obturée pour permettre le passage des moyens de connexion(7) is partially closed to allow the passage of the connection means
(8) de la micro -résistance (9) aux bornes du générateur de courant (10).(8) of the micro-resistance (9) to the terminals of the current generator (10).
11 Dispositif selon la revendication 6, caractérisé en ce que la différence de diamètre entre le diamètre interne du tube périphérique (1) et le diamètre de la micro -résistance (9) est compris entre 50 et 100 micromètres.11 Device according to claim 6, characterized in that the difference in diameter between the internal diameter of the peripheral tube (1) and the diameter of the micro-resistance (9) is between 50 and 100 micrometers.
8/ Dispositif selon la revendication 6, caractérisé en ce que : le diamètre interne du tube périphérique (1) est compris entre 0.2 et 0.8 mm, le diamètre externe du tube périphérique (1) est compris entre 0.3 et 1 mm.8/ Device according to claim 6, characterized in that: the internal diameter of the peripheral tube (1) is between 0.2 and 0.8 mm, the external diameter of the peripheral tube (1) is between 0.3 and 1 mm.
9/ Dispositif selon la revendication 6, caractérisé en ce que les parties distale (2) et médiane (2) du tube périphérique (1) se présentent sous la forme d'une aiguille en inox.9/ Device according to claim 6, characterized in that the distal (2) and middle (2) parts of the peripheral tube (1) are in the form of a stainless steel needle.
10/ Dispositif selon la revendication 6, caractérisé en ce que les parties distale (2) et médiane (2) du tube périphérique (1) se présentent sous la forme d'un cathéter réalisé en un matériau choisi dans le groupe du PEEK, PTFE, polyphénylsulfone.10/ Device according to claim 6, characterized in that the distal (2) and middle (2) parts of the peripheral tube (1) are in the form of a catheter made of a material chosen from the group of PEEK, PTFE , polyphenylsulfone.
11/ Dispositif selon la revendication 6, caractérisé en ce que la partie proximale du tube est réalisée en silicone.11/ Device according to claim 6, characterized in that the proximal part of the tube is made of silicone.
12/ Dispositif selon la revendication 6, caractérisé en ce qu'il est muni d'un dispositif de préhension sous la forme d'un manchon (11) réalisé en silicone recouvrant la jonction entre la partie médiane et la partie proximale.12/ Device according to claim 6, characterized in that it is provided with a gripping device in the form of a sleeve (11) made of silicone covering the junction between the middle part and the proximal part.
13/ Dispositif selon la revendication 6, caractérisé en ce qu'il est recouvert d'une gaine (17) munie de perforations latérales (19) reliée à un système d'aspiration.13/ Device according to claim 6, characterized in that it is covered with a sheath (17) provided with lateral perforations (19) connected to a suction system.
14/ Dispositif selon la revendication 13, caractérisé en ce que l'arrivée d'eau se présente sous la forme d'un tube souple (22) directement connecté de manière étanche sur le Y, le tube étant comprimé, au niveau de son extrémité proximale, entre deux rouleaux fixes (23,24) mus en rotation à la même vitesse au moyen d'un moteur. 14/ Device according to claim 13, characterized in that the water inlet is in the form of a flexible tube (22) directly connected in a sealed manner to the Y, the tube being compressed at its end proximal, between two fixed rollers (23,24) rotated at the same speed by means of a motor.
PCT/FR2008/052381 2007-12-28 2008-12-19 Device intended for heat administration into a human or animal tissue, vessel or cavity WO2009083688A2 (en)

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Applications Claiming Priority (2)

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FR0760443A FR2925837B1 (en) 2007-12-28 2007-12-28 DEVICE FOR ADMINISTERING WATER VAPOR IN HUMAN OR ANIMAL TISSUE, VESSEL OR CAVITE
FR0760443 2007-12-28

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FR2957777B1 (en) * 2010-03-23 2012-05-25 Nova Therma DEVICE FOR ADMINISTERING CALORIES IN HUMAN OR ANIMAL TISSUE, VESSEL OR CAVITY

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WO2006108974A1 (en) * 2005-04-12 2006-10-19 Centre D'etude Et De Recherche Medicale D'archamps Implantable tube for injection particularly of heat transfer fluid into all or part of a human or animal tissue
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