Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/54—Control of the diagnostic device
  • A61B8/546—Control of the diagnostic device involving monitoring or regulation of device temperature
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N7/00—Ultrasound therapy
  • A61N7/02—Localised ultrasound hyperthermia
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N7/00—Ultrasound therapy
  • A61N7/02—Localised ultrasound hyperthermia
  • A61N2007/025—Localised ultrasound hyperthermia interstitial

Definitions

• the present invention relates to devices used for the treatment by localized hyperthermia of more generally malignant tumors.
• applicators comprising a head responsible for bringing heat into the tissues concerned by using production means which have called upon several physical principles. It can be cited in this regard microwaves, ultrasound, heating resistors, lasers, etc.
• intratissular applicators which are designed to be brought to the within the area to be treated endoscopically or endochannel.
• the present invention relates specifically to second-order devices and therefore relates to intratissular applicators and, more particularly, applicators using ultrasound to heat the area or areas to be treated internally.
• US Pat. No. 5,620,479 describes an intratissular applicator comprising an application head of substantially cylindrical shape.
• the application head comprises several cylindrical ultrasonic transducers connected to an electric generator by conductive lines.
• the external or emitting face of the transducers is in relation to the wall of the application head which is transparent to ultrasound, while the internal face opposite to the emitting face is in relation to a volume of air.
• Such application heads are characterized by the fact that the cylindrical transducers produce divergent ultrasonic waves, so that the quantity of heat produced and therefore the rise in temperature decreases very rapidly as the distance from the producing source.
• the effectiveness of deep treatment in a given direction is therefore relatively limited, unless greater powers are involved which have the disadvantage of giving rise, by increasing the energy supplied by the applicator, to vaporization of the tissue in the vicinity and / or in contact with the head.
• intratissular applicators comprising one or more transducers generating waves ultrasound focused on one or more targets.
• US Pat. No. 5,402,792 presents an intratissular applicator comprising a head of substantially cylindrical shape delimiting a cavity in which a transducer is arranged, the emitting face of which is constituted by a concave acoustic lens having two acoustic foci. Furthermore, the emitting face of the transducer is covered at a distance from a waterproof membrane permeable to ultrasound, which delimits a cavity filled with degassed water to ensure an acoustic coupling between the emitting face and the membrane.
• the ultrasonic waves emitted by a focused transducer are, first of all, convergent to the focus then, then, diverging from the focus, so that the acoustic radiation is not homogeneous and that the amount of heat produced decreases very quickly as the distance from the focus and in a direction opposite to the transducer, as is the case for a cylindrical transducer.
• the present invention aims to remedy all of the above drawbacks by proposing a new ultrasonic applicator, preferably, intratissular of localized hyperthermic application, the design of which is chosen to make it possible to provide heat in a preferred direction while ensuring good penetration of acoustic energy combined with a homogeneous distribution thereof and allowing omnidirectional treatment in the case necessary.
• Another object of the invention is to produce an ultrasonic applicator which can be used easily by the endoscopic or endochannel route, by being introduced directly into a natural route or through the operating channel of an endoscope.
• the ultrasonic applicator for heating, internally, of an ultrasound absorbing medium has: - an application head comprising at least one ultrasonic transducer, one face of which is called emission is covered at a distance by a waterproof and ultrasonic transparent protective membrane, and of which another face, opposite to the emission face, is associated with means of non or low ultrasonic propagation; - means for remotely connecting the transducer to an electric generator,
• the applicator is characterized in that the ultrasonic transducer is planar and has a planar emission face for emitting substantially planar ultrasonic waves in a direction substantially perpendicular to the emission face.
• Another object of the invention is to provide means for controlling and regulating the temperature of the application head so as to allow any significant rise in temperature without the risk of formation of vaporization microbubbles.
• the applicator comprises means for cooling the transducer.
• the invention also relates to a method of heating an environment absorbing ultrasonic waves of the type consisting:
• an applicator comprising at least one ultrasonic transducer (8), - and to emit from the transducer (8), ultrasonic waves to heat said medium.
• this method is characterized in that it consists in using a planar transducer having a planar emission face for emitting substantially planar ultrasonic waves in a direction substantially perpendicular to the emission face and heating the region of the absorbent medium located opposite said emission face.
• the method also consists in moving the plane transducer in rotation, so as to heat a larger volume from the same general position of the applicator.
• the applicator then comprises means for rotating the transducer, individually or jointly with the application head.
• the heating method and the applicator according to the invention can, in particular, be implemented for the localized treatment internally, of regions absorbing ultrasound of the human body.
• the invention therefore also relates to a therapeutic method for the treatment by hyperthermia, of an ultrasound absorbing region of a human or animal body of the type consisting in:
• the method consists in using a planar transducer having a planar emission face for emitting substantially planar ultrasonic waves in a direction substantially perpendicular to the emission face and heating the region situated opposite the face. resignation.
• Fig. 1 is a sectional elevation of the applicator according to the invention.
• Figs. 2 and 3 are cross sections taken along lines II-II and III-III of FIG. 1.
• Fig. 4 is a top view, partly in section, of another embodiment of the applicator.
• Figs. 5 and 6 are cross sections taken along lines V-V and VI-VI of FIG. 4.
• Fig. 7 is a section taken along the broken line VII-VII of FIG. 5.
• the intratissular ultrasonic applicator comprises an application head 1 which is preferably but not exclusively made of a non-ferromagnetic material, so that it can be used in addition to treatment or control installations parallels such as that involving the principle of nuclear magnetic resonance.
• the head 1 is carried by a tubular element 2 which is here constituted by a rigid element adapted in any suitable manner sealed on the part 3 of the head 1, considered to be rear relative to a front end piece 4, said to be of penetration.
• the tubular element 2 could be entirely made up, or partly completed, by a sheath of flexible nature, to facilitate a controlled, endoscopic or endocanal path.
• a sheath could advantageously consist of a succession of coaxial wire windings in contiguous turns from a wire of circular or polygonal section.
• the head 1 comprises a body 5 forming the rear 3 and front 4 parts between which it has a recess 6 which is at least open on a part of the periphery of the body 5.
• the body 5 is generally of cylindrical shape and the part 4 then advantageously has an ogival shape, trunk-pyramidal or conical, although a spherical or semi-spherical shape can also be retained.
• the recess 6 is produced to delimit, substantially in the middle of its depth in the example shown, a shoulder or seat 7 on which can be mounted, adapted, immobilized with sealing, a planar ultrasonic transducer 8, of generally rectangular shape whose length is oriented in the direction of the longitudinal axis x-x ', of the body 5 and, more particularly, in the example illustrated, parallel to this axis.
• the ultrasonic transducer 8 is connected by surface connections 9 and 10 to two supply wires 11 and 12, which are engaged through the rear part 3 by means of a through hole 13 opening into the recess 6
• the supply wires 11 and 12 are connected to a power source, not shown, capable of applying frequencies to the order of 5 to 10 MHz to the transducer.
• the transducer 8 can then be supplied with a single-frequency or multi-frequency electrical signal depending on the nature of the desired ultrasonic emission.
• the sealed mounting of the transducer 8 on the shoulder 7 and the position of the latter relative to the bottom 14 of the recess 6 are defined so that after adaptation of the transducer, the latter delimits with the bottom 14 a chamber 15 which is filled air so as to constitute a means of ultrasonic non-propagation from the large rear face 16 of the transducer 8.
• the face of planar emission has dimensions sufficient to emit, during the operation of the transducer, substantially planar ultrasonic waves which do not diverge in the vicinity of the transducer and the applicator.
• the ultrasonic transducer 8 is associated with means for assessing its rise in temperature.
• such means are constituted by a thermocouple 18 which sealingly crosses the rear part 3 of the head 1 in order to be connected to a visual indicator 19, such as a temperature indicator.
• the thermocouple 18 is also preferably coupled to a regulating device 20 whose function appears in the following. It could be retained to replace the thermocouple 18 by an equivalent means for example, a means of measuring the variation of the electrical capacity of the ultrasonic transducer as a function of its temperature.
• the recess 6 is closed in its part opening at the periphery of the body 5 by means of a membrane 21 constituted by a sheet of a material involving only a low coefficient of ultrasonic attenuation.
• this membrane 21 is constituted by a sheet of low pressure polyethylene with a thickness of 12 ⁇ m attached to the body 5 by means of an appropriate adhesive such as an adhesive of the cyanocrylate type.
• the membrane 21 can be constituted by a tubular segment completely surrounding the body 5 or by a sectoral segment covering the opening of the recess 6.
• the presence of the membrane 21 makes it possible to delimit in the recess 6, with the face 17 of the transducer 8, a cavity 22 closed in leaktight manner and which is in communication, on the one hand, with a hole 23 made in part 4 at level of the external surface from which it opens and, on the other hand, with a so-called supply conduit 24, crossing the rear part 3.
• the conduit 24 is connected to a tubular element 25 forming part of a circuit circulation of a cooling fluid supplied by a pump 26 from a reserve 27.
• the cooling fluid can be of different nature, while being chosen so as to fulfill an ultrasonic coupling function between the transducer 8 and the membrane 21 while still completely occupying the cavity 22.
• a fluid consists of degassed water.
• the operation of the pump 26, at least with regard to the flow supplied, is placed under the dependence of the regulator 20 appreciating the rise in temperature of the ultrasonic transducer 8.
• the fluid circulation circuit could involve, in addition to the circuit go 25, a return circuit 28 also called “recovery”, formed in the front part 4, in place of the discharge hole 23. Such a recovery circuit could then be connected directly to the source 27.
• the part of the tubular element 2 following the rear part 3 of the head body 1 is filled with a material for occupation, sealing and filling intended to isolate, contain, maintain, confine and protect the control lines which are constituted by the supply wires 11 and 12, by the thermocouple 18 and by the circuit (s) 25.
• the applicator described above can be introduced due to its shape even close to or even in a tumor to be treated, internally, ie by endoscopic or intracanal route, so as to apply, within this zone, a rise in temperature which is created by the absorption of ultrasound in the absorbent medium or the tissues, located opposite the emission face, after the connection of the transducer 8 to the electrical source. Due to the presence of the air cushion occupying the chamber 15, the operation of the transducer 8 results in an ultrasonic emission only from the emission face 17 which produces a near, non-divergent field, passing through the cavity 22 and the membrane 21 in a direction of propagation normal to the plane of the emission face 17.
• the rise in temperature of the ultrasonic transducer 8 due to the fact that its electro-acoustic efficiency is less than 1, is assessed by means of the means 18 which provides information to the regulator 20 making it possible to control the operating conditions of the pump 26 to supply, inside the cavity 22 always full, a suitable flow rate of coolant, discharged through the hole 23 by natural perfusion into the tissues or by taking up through the conduit 28.
• the applicator comprises means for rotating the transducer.
• these means of rotation consist of the tubular element 2 which allows the application head 1 to rotate in rotation on its axis xx ′ and, consequently, the rotation of the transducer 8.
• the tubular element 2 has a high coefficient of torsional resistance to allow a suitable rotational drive of the application head.
• the means for rotating the transducer could also be constituted by motor or transmission means making it possible to rotate the transducer alone, without joint displacement of the application head.
• the rotation of the transducer is carried out around an axis parallel to a major axis of the emission face.
• the rotation of the transducer can be continuous during the transmission duration by being alternated or not, but also sequential by involving a step-by-step rotation of the transducer, so as to successively heat contiguous zones.
• the means according to the invention for controlling and regulating temperature from the emission face 17 of the transducer 8 and due to the emission of a directional near field according to arrow F it becomes possible to proceed to the treatment by localized hyperthermia of tumors of small volume or not, at a greater or less distance from the head 1 and to conduct, by this means, treatments of tumors which would ordinarily be considered, by their specific localization, inaccessible to all possibility hyperthermic application localized.
• the use of a transducer having a planar emission face allows the production of substantially planar ultrasonic waves which ensure a homogeneous and deep diffusion of the acoustic energy in the absorbing medium.
• the planar nature of the waves emitted by a planar transducer offers a higher acoustic power output compared to the power supplied to the transducer greater than that offered by a cylindrical transducer according to the prior art.
• an applicator according to the invention using a flat transducer of dimension 10 mm x 3 mm supplied by an electrical signal with a frequency of 10 MHz , so as to radiate at its emission surface, a power of 14 Watts / cm 2 , makes it possible to obtain, after an emission duration of 20 seconds, a lesion opposite the emitting face having a depth of 10 at 12 mm.
• an applicator having external dimensions identical to those of the previous one but using a cylindrical transducer according to the prior art with an external diameter of 3 mm and a length of 10 mm, supplied by an electrical signal with a frequency of 10 MHz, so as to radiate at its emission surface a power of 14 Watts / cm 2 , makes it possible to obtain, after an emission period of 20 seconds, a lesion, opposite the cylindrical emission face of the transducer, having a depth of only 2 to 3 mm. It therefore appears that, all else being equal, the use of a plane transducer according to the invention advantageously makes it possible to increase the depth of injury by a factor 3.33 to 6 compared to a cylindrical transducer.
• an applicator according to the invention such as that described above, implemented under the same conditions of electrical supply and power, it is possible by rotating the application head around its axis. , to generate, with an emission duration of 7 to 8 min, a cylindrical lesion having an outside diameter of 10 to 12 mm.
• an applicator according to the prior art with a cylindrical transducer such as that described above, only makes it possible to obtain a cylindrical lesion having an outside diameter of 10 to 12 mm with an emission duration of 18 to 20 mins.
• a groove or a passage 30 allowing the engagement of a guide wire 31 promoting intra evolution -channel of the head 1, in particular when the channel invested is of relatively small section and experiences variations in orientation with a small radius of curvature. It is also advantageously provided to link the body 5 by its rear part 3 to a wire traction element 32 whose function is to allow, in particular when the sheath 2 is formed in the form of a helical wire winding, to exert on the applicator a traction force to promote its extraction from the inside of the canal or from the endoscopic operator guide invested.
• Figs. 4 to 7 show a preferred industrial embodiment of the head 1 which comprises a body 5 ⁇ inserted in a tubular element 2, the length of which beyond the rear part 3 ,, is suitable for a typically endoscopic function or an endochannel function by association with a flexible deformable sheath sheltering as in the previous example the functional establishment lines remote from the head 1.
• the tubular element 2 comprises a window formed in correspondence with the recess 6 ,, such a window being closed as in the previous example by a membrane 21 x .
• the head 1 is equipped with a transducer 8, the position of which is preferably parallel by one of its large faces to the longitudinal axis of the body 5,.
• the head can be equipped with several transducers 8 which respond to a similar characteristic by being mounted in the same way to occupy all or part of the periphery of the body 5 while being located for each of them set back from this periphery in order to provide for the emission face 17 a coupling cavity by means of the cooling fluid.
• each transducer is associated with non or low ultrasonic propagation means placed in relation to the rear face 16 in order to favor the only emission of a useful near field from the face. 17. It can therefore be envisaged to have the head 1, for example two or three transducers.
• transducers 8 it is also possible to envisage having one or more transducers 8 so that they extend in a non-parallel manner to the axis xx 'while presenting an inclination relative to this axis so that the near field emitted adopts a direction not normal to this axis.
• the probe can be provided with at least one transducer 8 which would be arranged perpendicular to the axis x-x ', being located in the vicinity of the front part 4.
• the membrane 21 could then be produced in the form of a balloon surrounding the transducer at a distance to delimit a volume of protection and confinement of a cooling liquid and ultrasonic coupling.
• Fig. 7 shows that it may be advantageous to have the body 5, for example at the level of the recess 6, radiopaque markers 40 making it possible to assume a fluoroscopic marking function during an endoscopic or endocanal path.
• the applicator preferably comprises means for cooling the transducer. However, the applicator could also not include such cooling means.
• the applicator has been described in connection with medical treatment. However, the applicator could be used in any industrial application for which it is necessary to heat locally, an environment absorbing the ultrasonic waves, in a region located deep relative to the external surface of the object to be treated.
• a heating method according to the invention consists in piercing a small diameter channel for the passage of the applicator, up to the focus.
• a channel constitutes, of course, an artificial internal channel for the placement of the applicator.
• the transducer is supplied with electric current, of a given frequency, for a predetermined duration depending on the nature of the parasitic focus and the extent of the latter.
• the transducer can be powered by a multi-frequency current.
• the transducer can be moved in rotation to heat a wider angular region.
• This rotation can be continuous, alternating or not, throughout the duration of the treatment, or sequential step by step, so as to successively heat contiguous areas of the region to be treated.
• the heating method according to the invention could also be used for heating thermosetting resin injected deep into a piece of wood to be considered in the context, for example, of its restoration.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biomedical Technology (AREA)
• Public Health (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Veterinary Medicine (AREA)
• Radiology & Medical Imaging (AREA)
• Engineering & Computer Science (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Surgery (AREA)
• Heart & Thoracic Surgery (AREA)
• Physics & Mathematics (AREA)
• Biophysics (AREA)
• Pathology (AREA)
• Thermotherapy And Cooling Therapy Devices (AREA)
• Electrotherapy Devices (AREA)

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• 1997
  • 1997-06-11 FR FR9707529A patent/FR2764516B1/fr not_active Expired - Fee Related
• 1998
  • 1998-06-11 JP JP50178599A patent/JP2002503128A/ja not_active Ceased
  • 1998-06-11 AT AT98930828T patent/ATE397957T1/de not_active IP Right Cessation
  • 1998-06-11 EP EP98930828A patent/EP0988092B1/fr not_active Expired - Lifetime
  • 1998-06-11 DE DE69839606T patent/DE69839606D1/de not_active Expired - Lifetime
  • 1998-06-11 US US09/424,878 patent/US6379320B1/en not_active Expired - Lifetime
  • 1998-06-11 WO PCT/FR1998/001212 patent/WO1998056462A1/fr not_active Ceased
  • 1998-06-11 CA CA002293544A patent/CA2293544C/fr not_active Expired - Fee Related

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