WO1991011975A1 - Appparatus for surgically treating tissues using hyperthermia and dilation - Google Patents

Appparatus for surgically treating tissues using hyperthermia and dilation Download PDF

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Publication number
WO1991011975A1
WO1991011975A1 PCT/FR1991/000081 FR9100081W WO9111975A1 WO 1991011975 A1 WO1991011975 A1 WO 1991011975A1 FR 9100081 W FR9100081 W FR 9100081W WO 9111975 A1 WO9111975 A1 WO 9111975A1
Authority
WO
WIPO (PCT)
Prior art keywords
probe
lumen
balloon
tissues
prostate
Prior art date
Application number
PCT/FR1991/000081
Other languages
French (fr)
Inventor
Gérard Hascoet
François Lacoste
Muriel Cathaud
Eric Poincelet
Marian Devonec
Paul Perrin
Original Assignee
Technomed International
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 Technomed International filed Critical Technomed International
Priority to JP91504773A priority Critical patent/JPH05505536A/en
Publication of WO1991011975A1 publication Critical patent/WO1991011975A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12—Devices for heating or cooling internal body cavities
    • A61F7/123—Devices for heating or cooling internal body cavities using a flexible balloon containing the thermal element
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00274—Prostate operation, e.g. prostatectomy, turp, bhp treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22055—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation with three or more balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00547—Prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling

Definitions

  • the invention relates to an apparatus for the surgical treatment of hyperthermia tissues, preferably the prostate, comprising means for dilation.
  • Document EP-A-0248758 describes a microwave applicator inserted into the rectum for the treatment of the prostate by hyperthermia.
  • the microwave applicator is blocked in the rectum by a lateral balloon. Therefore, it is necessary to have special protection of the rectum.
  • channels are provided for the circulation of a coolant.
  • a catheter including a probe provided with a temperature detector inserted into the urethra into the bladder, making it possible to locate and determine the position of the microwave applicator described in EP-A-0 248 758.
  • a microwave applicator introduced into the rectum is not satisfactory in practice because the application is imprecise since the prostate is irradiated from a distance.
  • FR-88 15126 an apparatus for surgical treatment of hyperthermia tissues, preferably the prostate, comprising a urethral probe and means for thermal protection of sensitive tissues other than the fabrics to be treated, preferably comprising means forming a radio-reflecting screen.
  • the present invention aims to solve the new technical problem consisting in the supply of a solution allowing surgical treatment of hyperthermia tissues, in particular the prostate, in a precise manner, these tissues being accessible by a lumen while allowing to provoke, in progress or at the end of heat treatment, a dilation of this lumen, and in particular of the urethra, in the case of treatment of the prostate.
  • the present invention solves this technical problem in an extremely simple, semi-invasive manner, that is to say by using the natural cavities of the body, or lumens, usable on an industrial scale.
  • the present invention provides an apparatus for the surgical treatment of hyperthermia tissues, preferably the prostate, accessible by a lumen, of the type comprising a probe introduced into said lumen, comprising heating means, characterized in that it comprises means temporarily or intermittently increasing the outside diameter of the probe, arranged relative to the probe, so as to allow dilation of said lumen, at least in the tissues to be treated, when desired.
  • the means for temporarily or intermittently increasing the outside diameter of the probe comprise at least one dilatation balloon, comprising means for filling and / or emptying the dilatation balloon.
  • the means for temporarily or intermittently increasing the outside diameter of the probe are arranged on said probe outside thereof.
  • the means for filling and / or emptying the expansion balloon are connected to, or form part of, a cooling circuit of the probe.
  • the expansion balloon is made of a flexible material, capable of withstanding, without bursting, high pressures, up to 20 bars, for example in latex reinforced or not.
  • the probe comprises means for locking in position in said lumen.
  • these blocking means comprise at least one blocking balloon, for example made of latex, surrounding the probe, which can be expanded, to block the probe in position, by supplying inflation fluid, by means for supplying the blocking balloon, preferably independent, of the aforementioned expansion means.
  • the above-mentioned dilatation balloon extends longitudinally outside the probe over a distance sufficient to cause dilation of the lumen, at least in the tissues to be treated by hyperthermia, in particular the prostate.
  • the tissues to be treated are formed by the prostate, the aforementioned probe is a urethral probe and the lumen is the urethra.
  • the aforementioned heating means comprise a microwave generation device disposed in a central orifice of said probe.
  • This microwave generator device is advantageously that described in document FR-88 15126, and comprises a metal cable coaxial with the probe, surrounded by an insulating sheath over part of its length, said cable comprising at least one stripped portion of microwave emission, preferably disposed at an intermediate or distal level of the probe.
  • the aforementioned expansion balloon is advantageously located at the level of the heating means.
  • the device according to the invention makes it possible to cause, during or at the end of heat treatment, a dilation of the lumen, and therefore a compression of neighboring tissues. This significantly improves thermotherapy.
  • dilation of the urethra during or at the end of heat treatment results in compression of the surrounding prostatic and peri-vesical tissues, which improves unexpected, urination problems, usually allowing to eliminate them.
  • the single figure, attached, shows a schematic view in partial section.
  • a surgical treatment apparatus of tissues by hyperthermia is represented by the general reference number 500.
  • the apparatus includes a probe 520 to be introduced into a lumen of a patient, providing access to tissues to be destroyed by hyperthermia.
  • the 520 probe is a urethral probe inserted into the urethra up to the level of the prostate.
  • This probe is preferably essentially of the type described in the applicant's previous patent application FR-88 15126, which is incorporated here by reference and to which a person skilled in the art can refer.
  • this probe 520 is equipped with heating means 518, arranged in a central orifice 519, preferably comprising a microwave generation device as described in document FR-88 15126.
  • this microwave generator device comprises a metal cable coaxial with the probe, surrounded by a insulating sheath over part of its length, said cable comprising at least one stripped part of microwave emission, preferably disposed at an intermediate or distal level of the probe.
  • this device is characterized in that it comprises means (600) for temporarily or intermittently increasing the outside diameter of the probe, arranged relative to the probe so as to allow expansion of the lumen (not shown ), at least on the tissue to be treated, when desired.
  • the means 600 are arranged at least at the level of the prostate.
  • the means 600 comprise at least one balloon 610 for expansion, comprising means 620 for filling and / or emptying the balloon, preferably under high pressure, and in particular between approximately 2 and approximately 20 bars, and preferably between 5 and 7 bars which constitute advantageous pressure values to limit the cost of manufacturing and operating the device while ensuring in particular good longevity.
  • the means 600 are available on the probe 520 outside thereof, as shown.
  • the means 620 for filling and / or emptying the expansion balloon 610 are preferably connected to, or form part of, a cooling circuit for the probe, and in particular that described in document FR-88 15126.
  • the expansion balloon is made of a flexible material, capable of withstanding, without bursting, at high pressures, up to 20 bars, for example in latex reinforced or not.
  • the dilation balloon 610 is shown in the expanded state.
  • This embodiment is an integral part of the invention and therefore of the present description. It will be observed that in the dilated state, this balloon has essentially a cylindrical shape, with an outside diameter which depends on the characteristics of the constituent material and internal pressure values. It is thus understood that it is possible for the practitioner to adjust within wide limits the final value of the external diameter of the expansion balloon 610, which is particularly advantageous.
  • the probe 520 comprises blocking means 630 in position in the lumen.
  • These blocking means comprise at least one blocking balloon, 632 for example made of latex, surrounding the probe, which can be inflated, to block the probe in position, by supplying inflation fluid by means 633 for supplying the balloon. blocking 632, preferably independent of the expansion means 630.
  • the dilation balloon 610 extends longitudinally externally to the probe 520 over a distance sufficient to cause dilation of the lumen, at least at the level of the tissues to be treated by hyperthermia, in particular the prostate.
  • other blocking means 640 similar to the blocking means 22, FIG. 2 and 3 or 126, FIG. 4 of document FR-88 15126 can be arranged.
  • These other blocking means include advantageously a balloon which is placed within the framework of the treatment of the prostate, inside the bladder, as described in the document FR-88 15126.
  • the expansion balloon 610 is placed between the locking means 630 and 640, at an intermediate level, advantageously at least in part at the level of the hyperthermia heating means, generally at the level of the micro generation device. -waves.
  • the invention therefore makes it possible to dilate the lumen, preferably the urethra within the framework of the treatment of the prostate, during or at the end of heat treatment, thereby ensuring compression of the neighboring tissues as indicated above.
  • the invention also covers a method of therapeutic treatment, comprising the heating of tissues to be treated, by heating means advantageously comprising the use of a device for generating microwaves arranged in an emitting probe capable of being introduced into a lumen giving access to the vicinity of said tissues, characterized in that said lumen is expanded during or at the end of heat treatment of said tissues.
  • this expansion is carried out by providing the probe equipped with at least one expansion balloon.
  • this method is applied to the treatment of the prostate by hyperthermia, the emitting probe being a urethral probe introduced into the urethra up to the level of the prostate.
  • the dilation balloon is then provided on the probe outside it to be arranged at least partly at the level of the prostate during treatment.
  • the invention naturally includes all the means constituting technical equivalents of the means described as well as their various combinations.

Abstract

An apparatus for surgically treating tissues, preferably the prostate, using hyperthermia. The apparatus (500) for treating tissues which are accessible with a lumen, comprises a probe (520) inserted in the lumen and including a heating device (518), and is characterized in that it includes a device (600) for temporarily or intermittently increasing the outer diameter of the probe, the device being arranged relative to the probe in order to allow the lumen to dilate when required and at least in the area of the tissues to be treated. A very effective treatment of the prostate can therefore be carried out while dilating the urethra.

Description

APPAREIL DE TRAITEMENT CHIRURGICAL DE TISSUS PAR HYPERTHERMIE ET DILATATION APPARATUS FOR SURGICAL TREATMENT OF TISSUES BY HYPERTHERMIA AND DILATION
L'invention concerne un appareil de traitement chirurgical de tissus par hyperthermie, de préférence la prostate,comprenant des moyens de dilatation.The invention relates to an apparatus for the surgical treatment of hyperthermia tissues, preferably the prostate, comprising means for dilation.
Dans le document EP-A-0248758, on décrit un applicateur à micro-ondes inséré dans le rectum pour le traitement de la prostate par hyperthermie. L'applicateur à micro-ondes est bloqué dans le rectum par un ballonnet latéral. De ce fait, il est nécessaire d'avoir une protection particulière du rectum. Dans la sonde é ettrice rectale, il est prévu des canaux pour la circulation d'un liquide de refroidissement.Document EP-A-0248758 describes a microwave applicator inserted into the rectum for the treatment of the prostate by hyperthermia. The microwave applicator is blocked in the rectum by a lateral balloon. Therefore, it is necessary to have special protection of the rectum. In the rectal probe, channels are provided for the circulation of a coolant.
Dans EP-A-0 246 176, on décrit un cathéter incluant une sonde pourvue d'un détecteur de température inséré dans l'urètre jusque dans la vessie, permettant de localiser et de déterminer la position de l'applicateur à micro-ondes décrit dans EP-A-0 248 758. Une telle conception d'un applicateur à micro-ondes introduit dans le rectum n'est pas satisfaisant en pratique car l'application est peu précise puisqu'on irradie à distance la prostate. En outre, avec un tel dispositif, il est très difficile, voire impossible, de protéger le sphincter. Il en est de même, d'une manière générale, des tissus environnants. Ceci est particulièrement vrai pour la vessie notamment. Le déposant a décrit, dans une demande antérieure non publiée à ce jour, FR-88 15126, un appareil de traitement chirurgical de tissus par hyperthermie, de préférence la prostate, comprenant une sonde urétrale et des moyens de protection thermique des tissus sensibles autres que les tissus à traiter, de préférence comprenant des moyens formant écran radio-réfléchissant.In EP-A-0 246 176, a catheter is described including a probe provided with a temperature detector inserted into the urethra into the bladder, making it possible to locate and determine the position of the microwave applicator described in EP-A-0 248 758. Such a design of a microwave applicator introduced into the rectum is not satisfactory in practice because the application is imprecise since the prostate is irradiated from a distance. In addition, with such a device, it is very difficult, if not impossible, to protect the sphincter. The same is true, in general, of the surrounding tissues. This is particularly true for the bladder in particular. The applicant has described, in a previous application not published to date, FR-88 15126, an apparatus for surgical treatment of hyperthermia tissues, preferably the prostate, comprising a urethral probe and means for thermal protection of sensitive tissues other than the fabrics to be treated, preferably comprising means forming a radio-reflecting screen.
La présente invention a pour but de résoudre le nouveau problème technique consistant en la fourniture d'une solution permettant de traiter chirurgicalemeπt des tissus par hyperthermie, en particulier la prostate, d'une manière précise, ces tissus étant accessibles par un lumen tout en permettant de provoquer, en cours ou en fin de traitement thermique, une dilatation de ce lumen, et en particulier de l'urètre, dans le cas du traitement de la prostate.The present invention aims to solve the new technical problem consisting in the supply of a solution allowing surgical treatment of hyperthermia tissues, in particular the prostate, in a precise manner, these tissues being accessible by a lumen while allowing to provoke, in progress or at the end of heat treatment, a dilation of this lumen, and in particular of the urethra, in the case of treatment of the prostate.
La présente invention résoud ce problème technique d'une manière extrêmement simple, semi-invasive, c'est-à-dire en utilisant les cavités naturelles du corps, ou lumens, utilisable à l'échelle industrielle.The present invention solves this technical problem in an extremely simple, semi-invasive manner, that is to say by using the natural cavities of the body, or lumens, usable on an industrial scale.
Ainsi, la présente invention fournit un appareil de traitement chirurgical de tissus par hyperthermie, de préférence la prostate, accessibles par un lumen, du type comprenant une sonde introduite dans ledit lumen, comprenant des moyens de chauffage caractérisé en ce qu'il comprend des moyens d'augmentation provisoire ou par intermittence du diamètre extérieur de la sonde, disposés relativement à la sonde, de manière à permettre une dilatation dudit lumen, au moins au niveau des tissus à traiter, lorsque cela est désiré.Thus, the present invention provides an apparatus for the surgical treatment of hyperthermia tissues, preferably the prostate, accessible by a lumen, of the type comprising a probe introduced into said lumen, comprising heating means, characterized in that it comprises means temporarily or intermittently increasing the outside diameter of the probe, arranged relative to the probe, so as to allow dilation of said lumen, at least in the tissues to be treated, when desired.
Selon un mode de réalisation avantageux, les moyens d'augmentation provisoire ou par intermittence du diamètre extérieur de la sonde comprennent au moins un ballonnet de dilatation, comprenant des moyens de remplissage et/ou de vidange du ballonnet de dilatation.de préférence sous une pression élevée, et en particulier comprise entre environ 2 et environ 20 bars, et de préférence entre 5 et 7 bars.According to an advantageous embodiment, the means for temporarily or intermittently increasing the outside diameter of the probe comprise at least one dilatation balloon, comprising means for filling and / or emptying the dilatation balloon. Preferably under pressure high, and in particular between approximately 2 and approximately 20 bars, and preferably between 5 and 7 bars.
Selon une variante de réalisation particulière, les moyens d'augmentation provisoire ou par intermittence du diamètre extérieur de la sonde sont disposés sur ladite sonde extérieurement à celle-ci.According to a particular variant embodiment, the means for temporarily or intermittently increasing the outside diameter of the probe are arranged on said probe outside thereof.
Selon un autre mode de réalisation particulier, les moyens de remplissage et/ou vidange du ballonnet de dilatation sont reliés à, ou font partie de, un circuit de refroidissement de la sonde.According to another particular embodiment, the means for filling and / or emptying the expansion balloon are connected to, or form part of, a cooling circuit of the probe.
Selon une réalisation particulière, le ballonnet de dilatation est réalisé en un matériau souple, capable de résister, sans éclater, à des pressions élevées, pouvant atteindre 20 bars, par exemple en latex renforcé ou non. Selon encore un autre mode de réalisation particulier, la sonde comprend des moyens de blocage en position dans ledit lumen. De préférence, ces moyens de blocage comprennent au moins un ballonnet de blocage, par exemple en latex, entourant la sonde, qui peut être dilaté, pour bloquer la sonde en position, par alimentation en fluide de gonflage, par des moyens d'alimentation du ballonnet de blocage, de préférence indépendants,des moyens de dilatation précités. Selon un autre mode de réalisation avantageux, le ballonnet de dilatation précité s'étend longitudinalement extérieurement à la sonde sur une distance suffisante pour provoquer une dilatation du lumen, au moins au niveau des tissus à traiter par hyperthermie, en particulier la prostate. Selon une variante de réalisation particulièrement préférée, les tissus à traiter sont constitués par la prostate, la sonde précitée est une sonde urétrale et le lumen est l'urètre.According to a particular embodiment, the expansion balloon is made of a flexible material, capable of withstanding, without bursting, high pressures, up to 20 bars, for example in latex reinforced or not. According to yet another particular embodiment, the probe comprises means for locking in position in said lumen. Preferably, these blocking means comprise at least one blocking balloon, for example made of latex, surrounding the probe, which can be expanded, to block the probe in position, by supplying inflation fluid, by means for supplying the blocking balloon, preferably independent, of the aforementioned expansion means. According to another advantageous embodiment, the above-mentioned dilatation balloon extends longitudinally outside the probe over a distance sufficient to cause dilation of the lumen, at least in the tissues to be treated by hyperthermia, in particular the prostate. According to a particularly preferred embodiment, the tissues to be treated are formed by the prostate, the aforementioned probe is a urethral probe and the lumen is the urethra.
Selon encore un mode de réalisation particulier, les moyens de chauffage précités comprennent un dispositif de génération de micro-ondes disposé dans un orifice central de ladite sonde. Ce dispositif générateur de micro-ondes est avantageusement celui-décrit dans le document FR-88 15126, et comprend un cable métallique co-axial à la sonde, entouré par une gaine isolante sur une partie de sa longueur, ledit cable comprenant au moins une partie dénudée d'émission de micro-ondes, de préférence disposée à un niveau intermédiaire ou distal de la sonde. Dans cette réalisation, le ballonnet de dilatation précité se trouve avantageusement au niveau des moyens de chauffage.According to yet another particular embodiment, the aforementioned heating means comprise a microwave generation device disposed in a central orifice of said probe. This microwave generator device is advantageously that described in document FR-88 15126, and comprises a metal cable coaxial with the probe, surrounded by an insulating sheath over part of its length, said cable comprising at least one stripped portion of microwave emission, preferably disposed at an intermediate or distal level of the probe. In this embodiment, the aforementioned expansion balloon is advantageously located at the level of the heating means.
L'appareil selon l'invention permet de provoquer en cours ou en fin de traitement thermique une dilatation du lumen, et donc une compression des tissus voisins. Ceci permet d'améliorer la thermothérapie de manière significative. Dans le cas du traitement thermique de la prostate, une dilatation de l'urètre en cours ou en fin de traitement thermique aboutit à une compression des tissus prostatiques et péri-vésicaux voisins, ce qui améliore de manière inattendue, les problèmes de miction, en permettant en général de les éliminer.The device according to the invention makes it possible to cause, during or at the end of heat treatment, a dilation of the lumen, and therefore a compression of neighboring tissues. This significantly improves thermotherapy. In the case of heat treatment of the prostate, dilation of the urethra during or at the end of heat treatment results in compression of the surrounding prostatic and peri-vesical tissues, which improves unexpected, urination problems, usually allowing to eliminate them.
D'autres buts, caractéristiques et avantages de l'invention, apparaîtront clairement à la lumière de la description explicative qui va suivre faite en référence à un mode de réalisation d'un appareil selon l'invention de traitement chirurgical de tissus par hyperthermie, appliqués à l'utilisation préférée du traitement de la prostate, donné simplement à titre d'illustration et qui ne saurait en aucune façon limiter la portée de l'invention.Other objects, characteristics and advantages of the invention will appear clearly in the light of the explanatory description which will follow made with reference to an embodiment of an apparatus according to the invention for surgical treatment of tissues by hyperthermia, applied to the preferred use of prostate treatment, given simply by way of illustration and which in no way limits the scope of the invention.
La figure unique, annexée, représente une vue schématique en coupe partielle.axiale, longitudinale, représentant l'appareil selon l'invention de traitement chirurgical de tissus à détruire par hyperthermie dans son utilisation préférée pour le traitement de la prostate, les moyens de chauffage comprenant un dispositif de génération de micro-ondes étant enlevés pour une meilleure compréhension.The single figure, attached, shows a schematic view in partial section. Axial, longitudinal, showing the apparatus according to the invention for surgical treatment of tissues to be destroyed by hyperthermia in its preferred use for the treatment of the prostate, the heating means including a microwave generator device being removed for better understanding.
En référence à la figure unique annexée, un appareil de traitement chirurgical de tissus par hyperthermie est représenté par le numéro de référence général 500. Cet appareil comprend une sonde 520 destinée à être introduite dans' un lumen d'un patient, donnant accès à des tissus à détruire par hyperthermie.With reference to the single appended figure, a surgical treatment apparatus of tissues by hyperthermia is represented by the general reference number 500. The apparatus includes a probe 520 to be introduced into a lumen of a patient, providing access to tissues to be destroyed by hyperthermia.
Une application préférée de l'invention concerne le traitement par hyperthermie de la prostate. Dans ce cas, la sonde 520 est une sonde urétrale introduite dans l'urètre jusqu'au niveau de la prostate. Cette sonde est de préférence essentiellement du type de celle décrite dans la demande de brevet précédente du déposant FR-88 15126, qui est incorporée ici par référence et à laquelle l'homme de l'art pourra se reporter. En particulier, cette sonde 520 est équipée de moyens de chauffage 518, disposés dans un orifice central 519, de préférence comprenant un dispositif de génération de micro-ondes tel que décrit dans le document FR-88 15126.A preferred application of the invention relates to treatment with hyperthermia of the prostate. In this case, the 520 probe is a urethral probe inserted into the urethra up to the level of the prostate. This probe is preferably essentially of the type described in the applicant's previous patent application FR-88 15126, which is incorporated here by reference and to which a person skilled in the art can refer. In particular, this probe 520 is equipped with heating means 518, arranged in a central orifice 519, preferably comprising a microwave generation device as described in document FR-88 15126.
Avantageusement, ce dispositif générateur de micro-ondes comprend un cable métallique co-axial à la sonde, entouré par une gaine isolante sur une partie de sa longueur, ledit cable comprenant au moins une partie dénudée d'émission de micro-ondes, de préférence disposée à un niveau intermédiaire ou distal de la sonde. Selon la présente invention, cet appareil est caractérisé en ce qu'il comprend des moyens (600) d'augmentation provisoire ou par intermittence du diamètre extérieur de la sonde, disposés relativement à la sonde de manière à permettre une dilatation du lumen (non représenté), au moins au niveau des tissus à traiter, lorsque cela est désiré. Ainsi, dans l'application préférée du traitement de la prostate par hyperthermie, les moyens 600 sont disposés au moins au niveau de la prostate.Advantageously, this microwave generator device comprises a metal cable coaxial with the probe, surrounded by a insulating sheath over part of its length, said cable comprising at least one stripped part of microwave emission, preferably disposed at an intermediate or distal level of the probe. According to the present invention, this device is characterized in that it comprises means (600) for temporarily or intermittently increasing the outside diameter of the probe, arranged relative to the probe so as to allow expansion of the lumen (not shown ), at least on the tissue to be treated, when desired. Thus, in the preferred application of the treatment of the prostate by hyperthermia, the means 600 are arranged at least at the level of the prostate.
Selon un mode de réalisation avantageux, les moyens 600 comprennent au moins un ballonnet 610 de dilatation, comprenant des moyens 620 de remplissage et/ou de vidange du ballonnet, de préférence sous une pression élevée, et en particulier comprise entre environ 2 et environ 20 bars, et de préférence entre 5 et 7 bars qui constituent des valeurs de pression intéressantes pour limiter le coût de fabrication et de fonctionnement de l'appareil en assurant en particulier une bonne longévité.According to an advantageous embodiment, the means 600 comprise at least one balloon 610 for expansion, comprising means 620 for filling and / or emptying the balloon, preferably under high pressure, and in particular between approximately 2 and approximately 20 bars, and preferably between 5 and 7 bars which constitute advantageous pressure values to limit the cost of manufacturing and operating the device while ensuring in particular good longevity.
Avantageusement les moyens 600 sont diposés sur la sonde 520 extérieurement à celle-ci, comme représenté.Advantageously, the means 600 are available on the probe 520 outside thereof, as shown.
Les moyens 620 de remplissage et/ou vidange du ballonnet de dilatation 610 sont de préférence reliés à, ou font partie de, un circuit de refroidissement de la sonde, et en particulier celui décrit dans le document FR-88 15126.The means 620 for filling and / or emptying the expansion balloon 610 are preferably connected to, or form part of, a cooling circuit for the probe, and in particular that described in document FR-88 15126.
Selon une réalisation particulière, le ballonnet de dilatation est réalisé en un matériau souple, capable de résister, sans éclater, à des pressions élevées, pouvant atteindre 20 bars, par exemple en latex renforcé ou non.According to a particular embodiment, the expansion balloon is made of a flexible material, capable of withstanding, without bursting, at high pressures, up to 20 bars, for example in latex reinforced or not.
Dans la figure annexée, le ballonnet de dilatation 610 est représenté à l'état dilaté. Ce mode de réalisation fait partie intégrante de l'invention et donc de la présente description. On observera qu'à l'état dilaté, ce ballonnet a essentiellement une forme cylindrique, d'un diamètre extérieur qui dépend des caractéristiques du matériau le constituant et des valeurs de pression interne. On conçoit ainsi qu'il est possible pour le praticien de régler dans de larges limites la valeur finale du diamètre extérieur du ballonnet de dilatation 610, ce qui est particulièrement avantageux.In the appended figure, the dilation balloon 610 is shown in the expanded state. This embodiment is an integral part of the invention and therefore of the present description. It will be observed that in the dilated state, this balloon has essentially a cylindrical shape, with an outside diameter which depends on the characteristics of the constituent material and internal pressure values. It is thus understood that it is possible for the practitioner to adjust within wide limits the final value of the external diameter of the expansion balloon 610, which is particularly advantageous.
Selon un autre mode de ralisation particulier, la sonde 520 comprend des moyens de blocage 630 en position dans le lumen. Ces moyens de blocage comprennent au moins un ballonnet de blocage, 632 par exemple en latex, entourant la sonde, qui peut être gonflé, pour bloquer la sonde en position,par alimentation en fluide de gonflage par des moyens d'alimentation 634 du ballonnet de blocage 632, de préférence indépendants des moyens de dilatation 630.According to another particular embodiment, the probe 520 comprises blocking means 630 in position in the lumen. These blocking means comprise at least one blocking balloon, 632 for example made of latex, surrounding the probe, which can be inflated, to block the probe in position, by supplying inflation fluid by means 633 for supplying the balloon. blocking 632, preferably independent of the expansion means 630.
Selon un autre mode de réalisation particulier le ballonnet de dilatation 610 s'étend longitudinalemeπt extérieurement à la sonde 520 sur une distance suffisante pour provoquer une dilatation de lumen, au moins au niveau des tissus à traiter par hyperthermie, en particulier la prostate.According to another particular embodiment, the dilation balloon 610 extends longitudinally externally to the probe 520 over a distance sufficient to cause dilation of the lumen, at least at the level of the tissues to be treated by hyperthermia, in particular the prostate.
A la partie avant 520a de la sonde 520, il peut être disposé d'autres moyens de blocage 640 analogues aux moyens de blocage 22, figure 2 et 3 ou 126, figure 4 du document FR-88 15126. Ces autres moyens de blocage comprennent avantageusement un ballonnet qui est disposé dans le cadre du traitement de la prostate, à l'intérieur de la vessie, comme décrit dans le document FR-88 15126.At the front part 520a of the probe 520, other blocking means 640 similar to the blocking means 22, FIG. 2 and 3 or 126, FIG. 4 of document FR-88 15126 can be arranged. These other blocking means include advantageously a balloon which is placed within the framework of the treatment of the prostate, inside the bladder, as described in the document FR-88 15126.
On constate ainsi que le ballonnet de dilatation 610 se trouve disposé entre les moyens de blocage 630 et 640, à un niveau intermédiaire, avantageusement au moins en partie au niveau des moyens de chauffage par hyperthermie, en général au niveau du dispositif de génération de micro-ondes.It can thus be seen that the expansion balloon 610 is placed between the locking means 630 and 640, at an intermediate level, advantageously at least in part at the level of the hyperthermia heating means, generally at the level of the micro generation device. -waves.
L'invention permet donc de dilater le lumen, de préférence l'urètre dans le cadre du traitement de la prostate , pendant ou en fin de traitement thermique, en assurant ainsi une compression des tissus voisins comme indiqué précédemment. L'invention couvre également un procédé de traitement thérapeutique, comprenant le chauffage de tissus à traiter, par des moyens de chauffage comprenant avantageusement l'utilisation d'un dispositif de génération de micro-ondes disposés dans une sonde émettrice capable d'être introduite dans un lumen donnant accès au voisinage desdits tissus, caractérisé en ce qu'on réalise une dilatation dudit lumen pendant ou en fin de traitement thermique desdits tissus.The invention therefore makes it possible to dilate the lumen, preferably the urethra within the framework of the treatment of the prostate, during or at the end of heat treatment, thereby ensuring compression of the neighboring tissues as indicated above. The invention also covers a method of therapeutic treatment, comprising the heating of tissues to be treated, by heating means advantageously comprising the use of a device for generating microwaves arranged in an emitting probe capable of being introduced into a lumen giving access to the vicinity of said tissues, characterized in that said lumen is expanded during or at the end of heat treatment of said tissues.
Selon une variante de réalisation de ce procédé, on réalise cette dilatation en prévoyant la sonde équipée d'au moins un ballonnet de dilatation.According to an alternative embodiment of this method, this expansion is carried out by providing the probe equipped with at least one expansion balloon.
De préférence, ce procédé est appliqué au traitement de la prostate par hyperthermie, la sonde émettrice étant une sonde urétrale introduite dans l'urètre jusqu'au niveau de la prostate. Le ballonnet de dilatation est alors prévu sur la sonde extérieurement à celle-ci pour être disposé au moins en partie au niveau de la prostate en cours de traitement.Preferably, this method is applied to the treatment of the prostate by hyperthermia, the emitting probe being a urethral probe introduced into the urethra up to the level of the prostate. The dilation balloon is then provided on the probe outside it to be arranged at least partly at the level of the prostate during treatment.
L'invention comprend naturellement tous les moyens constituant des équivalents techniques des moyens décrits ainsi que leurs diverses combinaisons. The invention naturally includes all the means constituting technical equivalents of the means described as well as their various combinations.

Claims

REVENDICATIONS
1. Appareil de traitement chirurgical (500) de tissus par hyperthermie, de préférence la prostate, accessibles par un lumen, du type comprenant une sonde (520) introduite dans ledit lumen, comprenant des moyens de chauffage (518), caractérisé en ce qu'il comprend des moyens (600) d'augmentation provisoire ou par intermittence du diamètre extérieur de la sonde, disposés relativement à la sonde de manière à permettre une dilatation du lumen, au moins au niveau des tissus à traiter, lorsque cela est désiré.1. Apparatus for surgical treatment (500) of tissues by hyperthermia, preferably the prostate, accessible by a lumen, of the type comprising a probe (520) introduced into said lumen, comprising heating means (518), characterized in that 'It comprises means (600) for temporarily or intermittently increasing the outside diameter of the probe, arranged relative to the probe so as to allow expansion of the lumen, at least in the tissues to be treated, when desired.
2. Appareil selon la revendication 1, caractérisé en ce que les moyens (600) d'augmentation provisoire ou par intermittence du diamètre extérieur de la sonde (520) comprennent au moins un ballonnet de dilatation (610) .comprenant des moyens de remplissage et/ou de vidange du ballonnet de dilatation (610) , de préférence sous une pression élevée, en particulier comprise entre environ 2 et environ 20 bars, et de préférence entre 5 et 7 bars.2. Apparatus according to claim 1, characterized in that the means (600) for temporarily or intermittently increasing the outside diameter of the probe (520) comprise at least one expansion balloon (610). Comprising filling means and / or emptying the expansion balloon (610), preferably under high pressure, in particular between approximately 2 and approximately 20 bars, and preferably between 5 and 7 bars.
3. Appareil selon la revendication 1 ou 2, caractérisé en ce que les moyens (600) d'augmentation provisoire ou par intermittence du diamètre extérieur de la sonde (520) sont disposés sur ladite sonde extérieurement à celle-ci.3. Apparatus according to claim 1 or 2, characterized in that the means (600) for temporarily or intermittently increasing the outside diameter of the probe (520) are arranged on said probe outside thereof.
4.Appareil selon la revendication 2 ou 3, caractérisé en ce que les moyens de remplissage et /ou de vidange (620) du ballonnet de dilatation (610) sont reliés à, ou font partie de, un circuit de refroidissement de la sonde (520) .4.Apparatus according to claim 2 or 3, characterized in that the means for filling and / or emptying (620) of the expansion balloon (610) are connected to, or form part of, a cooling circuit of the probe ( 520).
5.Appareil selon l'une des revendications 2 à 4, caractérisé en ce que le ballonnet de dilatation (610) est réalisé en un matériau souple capable de résister, sans éclater, à des pressions élevées pouvant atteindre 20 bars, par exemple en latex renforcé ou non. 5. Apparatus according to one of claims 2 to 4, characterized in that the expansion balloon (610) is made of a flexible material capable of withstanding, without bursting, at high pressures up to 20 bar, for example latex reinforced or not.
6. Appareil selon l'une des revendications 1 à 5, caractérisé en ce que la sonde (520) comprend des moyens de blocage (630,640) en position dans le lumen.6. Apparatus according to one of claims 1 to 5, characterized in that the probe (520) comprises blocking means (630,640) in position in the lumen.
7. Appareil selon la revendication 6, caractérisé en ce que les moyens de blocage (630) , comprennent un ballonnet (632) ; par exemple en latex, entourant la sonde qui peut être gonflé pour bloquer la sonde en position par alimentation en fluide de gonflage, par des moyens d'alimentation (634) du ballonnet de blocage (632) , de préférence indépendants des moyens de dilatation (600). 7. Apparatus according to claim 6, characterized in that the locking means (630) comprise a balloon (632); for example in latex, surrounding the probe which can be inflated to block the probe in position by supplying inflation fluid, by supply means (634) of the blocking balloon (632), preferably independent of the dilation means (600).
8. Appareil selon l'une des revendications 2 à 7, caractérisé en ce que le ballonnet de dilatation (610) s'étend longitudinalement extérieurement à la sonde sur une distance suffisante pour provoquer une dilatation du lumen, au moins au niveau des tissus à traiter par hyperthermie, en particulier la prostate. 8. Apparatus according to one of claims 2 to 7, characterized in that the dilation balloon (610) extends longitudinally outside the probe over a distance sufficient to cause expansion of the lumen, at least in the tissues to be treat with hyperthermia, especially the prostate.
9.Appareil selon l'une des revendications 1 à 8, caractérisé en ce que les tissus à traiter sont constitués par la prostate, la sonde (520) est une sonde urétrale et le lumen est l'urètre. 9. Apparatus according to one of claims 1 to 8, characterized in that the tissues to be treated are formed by the prostate, the probe (520) is a urethral probe and the lumen is the urethra.
10. Appareil selon l'une des revendications 1 à 9, caractérisé en ce que les moyens de chauffage (518) comprennent un dispositif de génération de micro-ondes disposé dans un orifice central (519) de la sonde (520) . 10. Apparatus according to one of claims 1 to 9, characterized in that the heating means (518) comprise a microwave generation device disposed in a central orifice (519) of the probe (520).
PCT/FR1991/000081 1990-02-08 1991-02-05 Appparatus for surgically treating tissues using hyperthermia and dilation WO1991011975A1 (en)

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JP91504773A JPH05505536A (en) 1990-02-08 1991-02-05 Device for surgically treating tissue by expansion and thermotherapy

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FR90/01478 1990-02-08
FR9001478A FR2657773A1 (en) 1990-02-08 1990-02-08 APPARATUS FOR SURGICAL TREATMENT OF TISSUES BY HYPERTHERMIA, PREFERABLY PROSTATE, INCLUDING MEANS OF EXPANSION.

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FR2717375A1 (en) * 1994-03-18 1995-09-22 Sadis Bruker Spectrospin Endocavitary applicator, in particular for heating by microwave radiation of the uterus.
US5800486A (en) * 1996-06-17 1998-09-01 Urologix, Inc. Device for transurethral thermal therapy with cooling balloon
US6123083A (en) * 1997-08-29 2000-09-26 Urologix, Inc. Device and method for treatment of a prostate while preventing urethral constriction due to collagen rich tissue shrinkage

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FR2657773A1 (en) 1991-08-09
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JPH05505536A (en) 1993-08-19
CA2075378A1 (en) 1991-08-09

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