WO1999008634A1 - Dispositif de traitement thermique - Google Patents

Dispositif de traitement thermique Download PDF

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Publication number
WO1999008634A1
WO1999008634A1 PCT/SE1998/001457 SE9801457W WO9908634A1 WO 1999008634 A1 WO1999008634 A1 WO 1999008634A1 SE 9801457 W SE9801457 W SE 9801457W WO 9908634 A1 WO9908634 A1 WO 9908634A1
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WO
WIPO (PCT)
Prior art keywords
balloon
housing
medium
chamber
inlet
Prior art date
Application number
PCT/SE1998/001457
Other languages
English (en)
Inventor
Hans I. Wallsten
Original Assignee
Wallsten Medical S.A.
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 Wallsten Medical S.A. filed Critical Wallsten Medical S.A.
Priority to AU86548/98A priority Critical patent/AU8654898A/en
Publication of WO1999008634A1 publication Critical patent/WO1999008634A1/fr

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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
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
    • A61B1/127—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements with means for preventing fogging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—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
    • 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
    • A61B2018/00559—Female reproductive organs
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • 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
    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • 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
    • A61F2007/0054—Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water

Definitions

  • the present invention relates to devices for carrying out heat treatment in a body cavity or duct which has a narrow access pathway.
  • the device is quite generally constituted by an applicator comprising an inflatable balloon in which a heated medium is agitated or circulated.
  • Hyperthermia is a form of heat treatment which has been mainly used for the treatment of malign tumors, and such treatment is normally performed at a relatively low temperature, such as about 43-45°C. It has also been suggested to treat certain benign or malign diseases in body cavities by necrosis at considerably higher temperatures. For the treatment of disorders in body cavities or ducts with narrow access pathways, such as the prostate, the bladder neck, the bladder and the uterus, it has been suggested to use balloon catheters of different designs, where a deflated balloon at the distant end of a catheter is introduced into the cavity or duct subject to treatment and is then inflated by a heating medium, usually a liquid.
  • a heating medium usually a liquid.
  • Heating means arranged in the balloon then heat the medium to a certain temperature, and the treatment temperature and time is selected to create necrosis or cauterization of the diseased tissue.
  • Such apparatus for effecting thermal cauterization of for example the human uterine endometrium is disclosed in EP 0 433 376 to Neu- wirth.
  • the heating medium is not circu- lated within the balloon, and this results in the drawback that the heat will not be evenly distributed to the surrounding body tissue resulting in uneven necrosis of the organ subject to treatment.
  • US patent 5,571,153 to allsten describes a device for thermal treatment of body cavities or ducts with narrow access pathways, such as uterus or prostate. This device is based on the generation of an oscillating pressu- re resulting in internal circulation of the heating medium within the balloon. This safequards even treatment resulting from an even temperature over the entire treatment area. However, at higher treatment temperatures the heat will be distributed backwards in the instrument rea- ching sensitive areas of the body duct, and this will impart a limitation with regard to the level of temperature and with regard to possible reduction of the diameter of the catheter.
  • the present invention has for a main object to eliminate the disadvantages associated with the prior art devices for the treatment of disorders in body cavities or ducts having narrow access pathways.
  • the main object of the present invention is to provide a device enabling heat treatment at high temperatures to create necrosis or cauterization of diseased tissue without imparting risks to delicate tissues along the access pathway.
  • Another object of the invention is to provide a device which in a deflated state can be designed with a small catheter diameter to avoid unnecessary dilation of the body duct in connection with the introduction of the catheter.
  • Yet another object of the invention is to provide a device enabling intensive heating during treatment coup- led with even distribution of heat to the organ to be treated.
  • Still another object of the invention is to provide a device or instrument in which the active length of the balloon can be adjusted to adapt to body cavities or ducts of varying dimensions.
  • Still another object of the invention is to provide a device where the heating medium can be circulated or agitated inside the balloon to ensure even heat distribution during treatment.
  • the invention provides for a device for carrying out heat treatment in a body cavity or duct having a narrow access pathway, said device comprising an elongate distal section intended to be inserted into said cavity or duct and including a centrally located heat releasing element which is accomodated in an elongate housing.
  • a flexible and/or elastic balloon surrounding said housing in a liquid- tight manner, and further including means for supplying energy to said element and an axially operating inlet passage at the proximal part of the housing, at least one outlet from the housing being arranged for the supply via the inlet passage of heat-transmitting medium under pressure for expansion of the balloon to accomodate to and to exert, under heating, a controlled pressure on surrounding walls of said cavity or duct.
  • the device according to the invention further includes means acting to provide a reciprocating motion to a quantity of pressurized medium, said motion being transferred via the inlet passage to the interior of said housing and said balloon to agitate or circulate said medium therein.
  • the device according to the invention is characterized by a chamber positioned in the inlet passage at the proximal end of the housing, and further characterized by a body placed in said chamber and movable between the distal and proximal ends of said chamber while allowing a restricted flow of medium around and/or through said body for filling and emptying the balloon, said body moving back and forth within said chamber due to said reciprocating motion.
  • distal and proximal refer to the forward end and the rear end of the part of the device to be inserted into a body cavity or duct.
  • distal end of the instrument is the front end of the instrument initially entering such body cavity or duct.
  • the restricted flow of heating medium permitted by the body positioned in the proximally placed chamber can either take place via a circumferential play between the body and the surrounding chamber wall or can be provided by at least one axial passage through said body, or both.
  • the device according to the invention is characterized by at least one first backvalve arranged in association with an inlet for the heating medium arranged in the housing on the other side of the element relative to the outlet, and by a partition placed between the inlet and the element or between the element and the outlet, respectively, to form a chamber which is provided with an axial aperture or opening containing a second backvalve which acts oppositely to the first backvalve placed in the inlet.
  • the means for the flow of the heating medium in an internal circuit is arranged to provide a reciprocating movement of a small quantity of the heating medium enclosed in the inlet passage of the device after expansion of the balloon, whereby the inlet is closed and the outlet is open, or the inlet is open and the outlet is closed, respectively. In this manner circulation of the heating me- dium in a closed circuit inside the balloon will be provided.
  • the elongate housing can be provided with several openings allowing access via the inlet passage to the interior of the balloon. In this manner said means providing reciprocating movement provides agitation of the heating medium inside the balloon.
  • the means for providing a reciprocating movement of a small quantity of the heating medium can comprise a re- ciprocating piston or membrane.
  • the free volume of said chamber i.e. excluding the volume of the movable body, can be larger than the volume of the reciprocating quantity of pressurized or heating medium.
  • Said free volume of the chamber need only be somewhat larger than the volume of the reciprocating quantity of pressurized medium since excess of volume only tends to enlarge the instrument without resulting in any further advantage.
  • the distal end of the housing is attached to the balloon.
  • a drainage valve positioned at the distal end of the housing which is operable from the outside for the drainage of gas from the interior of the balloon in connection with the filling of the balloon with heating medium.
  • the proximal end of the bal- loon is sealed aginst and around the proximal end of the housing, and the device contains a displaceable sleeve surrounding said end of the balloon.
  • a displaceable sleeve surrounding said end of the balloon.
  • said device can be provided with a viewing opening located at the proximal end of the housing and proximal to the balloon. Such opening enables visual access to the exterior of said distal section to facilitate positioning of the device.
  • the elongate distal section may accomodate an endoscope for visual inspection of the positioning of the device.
  • said balloon can be constituted by a double-layered balloon comprising an inner elastic and liquid-tight layer, and an outer layer of limited elasticity.
  • it can be designed as a triple-layered balloon comprising said inner elastic layer, an intermediate layer of limited elasticity corresponding to said outer layer, and an outer elastic layer.
  • Layers of limited elasticity may be comprised by braided or woven tubes, the filaments of which have limited elasticity, at least in a circumferential direction.
  • layer of limited elasticity may be comprised of a winding of a filament of limited elasticity.
  • Figures 1 and 2 illustrate the state of the art according to US patent 5,571,153, of which the present in- vention constitutes important developments and improvements;
  • Figure 3 shows diagramatically a section through the distal section of an embodiment of the device according to the invention;
  • Figure 4 shows a similar section of another embodi- ment of the device of the invention.
  • Figure 5 is a diagrammatic sideview illustration through the distal section of an embodiment of the device according to the invention.
  • Figure 6 illustrates circular sections along lines II-II and I-I of figure 5;
  • Figure 7 illustrates a section through a triple- layered balloon or enclosure in deflated and inflated state, respectively.
  • Figure 8 illustrates a section through an alternati- ve embodiment of the device, said section corresponding to the section along line I-I of figure 6.
  • FIG. 1 and 2 of the drawings correspond to drawing figures 1 and 2 of said US patent and are used for this purpose.
  • the device described in figures 1 and 2 includes a heat applicator 1 with a distal part 3 to be inserted in a body cavity, for example the uterus, and a proximal part 7 with connecting means to an electric source 13 supplying an electric current via wires 15 to a central body 17 containing a heat-emitting element 19.
  • the applicator is provided with means 23 for connection to an apparatus 25 for the generation of oscillating pressure impacts to the inlet passage 35 filled with a pressurized liquid from a liquid source 11.
  • apparatus 25 operates through a reciprocating piston.
  • the central body 17 is surrounded by an expandable balloon 37 and comprises a housing 29 provided with apertures 31 and 33.
  • FIG. 2 shows in detail a system for effective heat transfer from the elements 19 to the mucosa of the uterus.
  • Apertures 31 act as radial inlets for a pressuri- zed liquid to a valve housing 32 communicating with the inlet passage 35 and the space between central body 17 and balloon 29, as well as canals 21 in the element 19.
  • Apertures 33 act as outlets for the pressurized liquid communicating with canals 21 and the space between the central body 17 and the balloon 37.
  • Back valves 49 are arranged to close apertures 31 at over-pressure and opening at sub-pressure.
  • a disc valve 47 is arranged to close at over-pressure and open at sub-pressure.
  • Element 19 can be of any type operated by electric current and is connected to a supply of electric current preferably not exceeding 24V from a safety point of view. Another requirement is that the temperature necessary for the treatment can be maintained but not exceeded, which can be provided by suitable means not shown. It is appreciated that under the influence of the oscillating pressure shocks, a powerful and effective circulation in an internal flow circuit of liquid at a given pressure will be provided in the distal part 3 without hot liquid passing the inlet passage 35 to con- necting means 23.
  • the inlet passage 35 during the circulation only serves as a communication conduit for transmitting the oscillating pressure and liquid movement provided by the pump apparatus 25. Therefore, the passage 35 can have a small diameter and therefore space is admitted for the heat insulation 26 surrounding the intermediate part 5 of the catheter.
  • Suitable temperatures for the treatment of uterus with a device according to figures 1 and 2 of the drawings are about 70°C, and the diameter of the catheter should not exceed 7-8 mm.
  • the normal diame- ter of the cervix canal is about 3-5 mm and it is therefore necessary to dilate the canal before the catheter is introduced. A dilation of 6-7 mm can easily be made but a dilation of about 10 mm or more can be painful and could require deeper anaesthesia.
  • FIG. 3 illustrates an embodiment of the device ac- cording to the present invention which constitutes an improvement of the devices disclosed in US patent 5,571,153 and in particular the embodiment shown in figure 2.
  • a heat applicator corresponding to applicator 3 in figure 1 is designated 103 and is intended to be connected to an electric source, a means for introducing a pressurized liquid and a means for the generation of oscillating pressure impacts. These means are not shown in the drawing but have been described in connection with figure 1.
  • Heat-emitting elements 119 are enclosed in a central body constituted by a housing 129 provided with apertures 131 and 133.
  • Apertures 131 act as radial inlets for a pressurized liquid to a valve space 132 communicating with an inlet passage 135 and a space between housing 129 and balloon 137, as well as passages or canals 121 in the element 119.
  • Apertures 133 act as outlets for the pressurized liquid communicating with canals 121 and the space between the housing 129 and the balloon 137.
  • Back valves 149 are arranged in association with apertures 131 to close same at over-pressure and to open same at sub-pressure.
  • a disc-valve 147 is arranged to open at over-pressure and to close at sub-pressure.
  • a chamber 150 is arranged at the proximal end of the valve housing 132 or an extension thereof and stands in communication with passage 135.
  • housing 129, as well as valve housing 132 and chamber 150 have circular cross-sections.
  • a piston or movable body 151 is located in chamber 150. This body 151 can move freely axially forth and back due to the fact that it has a diameter somewhat smaller than the inner diameter of chamber 150. In the center of body 151 an axial opening or hole 152 has been provided to allow for the passage of electrical wires 115 to the heating element 119.
  • the chamber 150 ends proximally at 153 and the body 150 can only move between this proximal end 153 and a stop 154 arranged in housing 132. If the body 151 has a thickness of t mm and the chamber 150 a length of 1 mm the body can move freely for a total length of 1-t mm.
  • the piston 151 will start to oscillate under the influence of the pressure shocks and movement of the oscillating liquid in passage 135.
  • the movable body 151 is shown in its end position butting end 153. If it is assumed that the oscillating movement of the liquid starts with a positive stroke of the oscillator, a certain amount of liquid starts to move creating an over-pressure. The body 151 will start to move towards the stop 154 leaving a space in chamber 150 which will subsequently be filled with a cold liquid from passage 135.
  • the body 151 will push an amount of hot liquid out into the valve housing 132 and further through the elements 119 and the disc-valve 147 through apertures 133 and out in the space between the balloon 137 and the housing 129 somewhat increasing the size of the balloon.
  • body 151 has a somewhat smaller diameter than the chamber 150. This is important because it creates passage for a limited amount of heating liquid, which will be explained later.
  • body 151 will move axially providing a space filled with cold liquid the volume of which corresponds to the total volume of the positive stroke reduced by the volume of liquid which has passed body 151.
  • body 151 When the oscillating pump generates a negative stroke, body 151 will reverse and move in direction towards the chamber 153 filling the left part of the space 150 with hot liquid and emptying the right part of said space of cold liquid.
  • the possibility for the liquid to pass the body 151 is important for several reasons.
  • Another is to make it possible to perform the necessary pressure changes during a treatment.
  • the starting point for the body at a positive stroke was the right-hand position shown in figure 3.
  • an important pressure would have been created when the body stopped at 154 thus allowing a more important flow to pass across the body.
  • the body can start from a "correct" left-hand position. The arrangement with a play between body and surrounding chamber wall will thus enable correction of the position of the body.
  • the volume of the chamber 150 excluding the volume of the body 151 is somewhat larger than the volume of the stroke of the oscillating pump.
  • a certan minimum quantity of the heat-transmitting liquid must be circulated. The quantity is depending on the stroke volume and the frequency.
  • a circulated quantity of about 0.2 to 2.0 ml per second can be used. It is not a problem to design a pump in the form of a piston or a membrane to create an oscillating volume per second corresponding to these figures.
  • the feature of the present invention thus enables the creation of a sharp limit between a hot and a cold zone as indicated in figure 3.
  • the body should have a suitable thickness, such as at least about 3 mm and preferably be made from a material of low heat conductivity, such as a porous, non- absorbing plastic.
  • FIG 4 there is shown an alternative embodiment of the device according to the invention. Also in this case the device is intended to be connected to an apparatus for the generation of oscillating impacts.
  • the device of figure 4 differs from that of figure 3 in that there are no means for internal circulation such as by using back-valves.
  • housing 160 is provided with several holes 161 acting as both inlets and outlets for the heat-transmitting liquid.
  • the shock waves from the oscillating generator are transmitted via body 151 to the liquid in the housing 160, and at each positive stroke hot liquid will be pressed out through the holes 161 creating turbulence inside the balloon 137 and the housing 160.
  • No circulation but an effective agitation can be achieved and has the advantage that the device has a simpler and cheaper design.
  • the embodiment of figure 4 is further provided with a drainage valve 164 for the escape of air when filling the device with heat-transmitting liquid. Trapped air can be released through an outlet 162 by inserting a pin through an opening 163 to lift a valve element 165 from its seat by compressing the spiral spring 164.
  • the device shown in figure 4 is further provided at the proximal end of the balloon 137 with a sleeve 170 which is axially displacable.
  • the balloon 137 is sealed at is proximal end 172 to the center shaft 173.
  • the position of the distal end 171 of sleeve 170 will, therefore, determine the active length of the inflated balloon 137.
  • This enables adjustment of the length of the balloon, which is an advantage in for instance thermal treatment of uterus. A better adaptation to the uterus cavity can be achieved and expansion of the hot balloon in the cervix canal can be avoided.
  • Sleeve 170 can, after adjustment, be fixed against the catheter shaft 173 by means known per se but not shown in the drawing.
  • sleeve 170 can be replaced by a set of sleeves of varying length for proper selection of active balloon length.
  • Another alternative is constituted by the application of a simple tape or similar means to provide the desired active balloon length.
  • FIG. 5 shows in detail the distal part of the applicator according to another embodiment of the inven- tion.
  • the balloon 202 is flexible and sealed at least at its proximal end to the distal end of the housing 220.
  • a heating means 221 is arranged illustrated as a resistor wire.
  • An outlet opening 253 is arranged distal to the heating means 221 and is associated with a back valve 257 allowing outlet but preventing inlet through said opening 253.
  • the back valve 257 is arranged in a space which through outlets 254 is in fluid connection with the interior of the balloon 202.
  • Inlet openings 255 with associated back valves 256 are arranged.
  • Back valve 256 allows entrance from the interior of the balloon 202 into the interior of housing 220.
  • the device according to figure 5 operates by inter- nal circulation in the same way as described in connection with figure 2. Accordingly, such internal circulation is provided by a means 25 providing reciprocating motion of the medium used for filling and heating of the balloon.
  • a means 25 providing reciprocating motion of the medium used for filling and heating of the balloon.
  • an opening 205 is provided through which by the use of an endoscope 204 through an endoscope lens 223 the practitioner can position the device properly in the target organ or duct, so that for example a sensitive area, such as an external sphincter, can be placed opposite to the applicator part between the distal end of the balloon and the opening 205.
  • a tube 225 is connected to valve 13 (fig. 1) for inflating and deflating the balloon with the liquid serving as heat-transmitting fluid for heat released from heating means 221.
  • the distal end of tube 25 is attached to a partition 38, which contains an inlet/outlet hole for the liquid in the tube 225.
  • a space 260 is arranged distal in relation to the wall 238 of housing 220.
  • a movable body 261 can freely move longitudinally back and forth in space 260.
  • the applicator is connected to an oscillating pump according to the principle shown in figure 1 for an effective circulation of the heating medium. Because of the oscillating movement of the liquid in tube 25 body 261 will also oscillate. At the end of each withdrawal stroke of the pump body 261 will stop in a position corresponding to the dotted lines 263.
  • the volume of space 260 excluding the volume of the body 261 should be about the same or somewhat larger than the volume of one stroke of the oscillating pump.
  • an irrigating liquid is introduced proximally of opening 205 as shown by arrow 233.
  • a horisontal wall 30 is arranged wit- hin the conduit leading to the proximal part of housing 220 and creates an upper space 231 and a lower space 232.
  • the cooling liquid is introduced to the lower space 232 and flows in the direction of arrow 233.
  • the wall 230 ends at 234 allowing the liquid to mount and return in the opposite direction as shown by arrows 235 and 236.
  • the cooling keeps the inner walls of the proximal parts of the distal section cool and particularly the area close to the hot balloon 202 and the separating wall 238.
  • Figure 6 shows the cross-sections I-I and II-II, re- spectively, and particularly how the wall 230 creates an upper space 231 and a lower space 232. Cables and wires 237 for the heater 219 are shown and the arrangement allows temperature control in a manner not shown.
  • Figure 8 shows an alternative arrangement to that shown by section I-I of figure 6.
  • the flow passages and accommodation of the endoscope 23 is provided by an extruded solid body 39, wherein the different flow passages and accommodation spaces are indicated by reference numerals corresponding to those of figure 6.
  • a hot zone at the distal part of the applicator including the inflated part of the balloon 202 and a cool zone proximal to the inflated balloon 202.
  • the practitioner can keep the applicator in such a position that sensitive tissue is protected from thermal damage while the thermal treatment at a high temperature is performed around the active part of the balloon.
  • the cooling liquid will also on its return serve as an irrigating liquid for the endoscopic lens 223.
  • Figure 4 shows an arrangement, whereby the active length of the balloon can be adjusted using a sleeve 170 at the proximal part of the balloon.
  • Figure 5 shows a similar arrangement for the adjustment of the active length of the balloon but in this case through the use of means positioned at the distal end of the balloon 202.
  • the distal end 243 of the balloon 202 is liquid-tight sealed to housing 220.
  • a part of the distal section 244 of the balloon cannot thereby expand when the balloon is inflated as it is surrounded by an axially displaceable. end piece in the form of a cap 245.
  • the dot- ted lines show the outermost end position of cap 245 and the distal end of the balloon.
  • the cap can be maintained in a fixed position by locking means not shown.
  • the cap can be replaced by a sleeve or a set of sleeves of varying length for obtaining the desired acti- ve length of the balloon 202.
  • the inflated balloon has a circular cross- section with a predetermined diameter. This can be obtained by using preformed flexible thin tubes with low elas- ticity. Irrespective of the shape of the cross-section the drawback of using preformed flexible thin tubes with low elasticity is that such deflated balloon has wrinkles causing problems at insertion of the device.
  • An alternative solution is to use a multilayer balloon consisting of layers of an elastomer, such as silicon, and a surrounding elastic material which can be extended only to a certain upper limit.
  • a suitable material of limited ex- pandability is an elastic clothing used for socks and stockings which is made by a so called stretchible yarn composed by an elastic filament, such as LycraTM, in the core and a less elastic filament, such as NylonTM wound around the core. Such a yarn is highly elastic but there is an upper limit for the expansion when the nylon filament is stretched.
  • a clothing woven in the form of a sleeve or tube has a certain diameter in released form and can be expanded to a maximum predetermined diameter and resist high pressures.
  • Figure 7 illustrates cross-sections of such a multi- layer balloon in a deflated and inflated state, respectively.
  • the layer of limited elasticity can be comprised of a braided or woven tube, the filaments of which have a limited elasticity at least in a circumferential direc- tion.
  • said layer of limited elasticity may be comprised of a winding of a filament of limited elasticity placed around the inner elastic layer and wound around said layer expanded to the desired dimension.
  • the layer of limited elasticity can be made to any dimension, by varying the tension in winding, the degree of close winding etc.
  • the tube of limited elasticity can be made with a cross-section vary- ing along its length, such as conical configuration. This can be done by placing the inner elastic layer onto a core of corresponding configuration.

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  • Surgical Instruments (AREA)

Abstract

Cette invention concerne un dispositif permettant d'effectuer un traitement thermique dans la cavité d'un corps ou dans une conduite dont la voie d'accès est étroite. Ce dispositif comprend une section distale allongée (103), ainsi qu'un élément émetteur de chaleur (119) qui est disposé dans une enceinte allongée (129). Un ballonnet flexible et/ou élastique (137) entoure cette enceinte de manière à la rendre étanche aux liquides. Ce dispositif comprend également un passage d'admission (135) fonctionnant dans le sens axial qui est situé dans la partie proximale de l'enceinte (129), et au moins une sortie (133) servant à l'admission d'un milieu conduisant la chaleur. Ce dispositif comprend en outre un système (25) permettant d'y agiter ou d'y faire circuler ledit milieu, lequel système se caractérise par une chambre (150) disposée dans le passage (135) à l'extrémité proximale de l'enceinte (129), ainsi que par un corps (151) disposé dans ladite chambre (150). Ce corps est capable de se déplacer entre les extrémités proximale et distale de la chambre (150) tout en assurant un débit réduit du milieu autour et/ou à travers ledit corps (151) afin de remplir et de vider le ballonnet (137).
PCT/SE1998/001457 1997-08-19 1998-08-11 Dispositif de traitement thermique WO1999008634A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU86548/98A AU8654898A (en) 1997-08-19 1998-08-11 Device for heat treatment

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE9702984A SE9702984D0 (sv) 1997-08-19 1997-08-19 Device for heat treatment
SE9702984-7 1997-08-19

Publications (1)

Publication Number Publication Date
WO1999008634A1 true WO1999008634A1 (fr) 1999-02-25

Family

ID=20407969

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE1998/001457 WO1999008634A1 (fr) 1997-08-19 1998-08-11 Dispositif de traitement thermique

Country Status (3)

Country Link
AU (1) AU8654898A (fr)
SE (1) SE9702984D0 (fr)
WO (1) WO1999008634A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002064070A1 (fr) * 2001-02-09 2002-08-22 Wallsten Medical S.A. Catheter a ballonnet et methode de traitement d'un conduit ou d'une cavite de mammifere par pression ou chaleur
US7156860B2 (en) 2000-05-26 2007-01-02 Wallsten Medical S.A. Balloon catheter
CN117563113A (zh) * 2024-01-15 2024-02-20 上海玄宇医疗器械有限公司 推杆调节机构及其球囊导管

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5084044A (en) * 1989-07-14 1992-01-28 Ciron Corporation Apparatus for endometrial ablation and method of using same
SE469966B (sv) * 1992-04-16 1993-10-18 Hans Ivar Wallsten Apparat för utförande av hypertermi i en kroppshålighet eller kroppskanal
WO1994007445A1 (fr) * 1992-09-30 1994-04-14 Neuwirth Robert S Dispositif medical a ballonnet gonflable chauffe comportant des moyens d'agitation de fluide
WO1994021202A1 (fr) * 1993-03-19 1994-09-29 Packard Development S.A. Dispositif de traitement medical
WO1998029068A1 (fr) * 1996-12-31 1998-07-09 Gynecare, Inc. Ballonnet chauffe dote d'un agitateur de fluide a mouvement alternatif

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5084044A (en) * 1989-07-14 1992-01-28 Ciron Corporation Apparatus for endometrial ablation and method of using same
SE469966B (sv) * 1992-04-16 1993-10-18 Hans Ivar Wallsten Apparat för utförande av hypertermi i en kroppshålighet eller kroppskanal
WO1994007445A1 (fr) * 1992-09-30 1994-04-14 Neuwirth Robert S Dispositif medical a ballonnet gonflable chauffe comportant des moyens d'agitation de fluide
WO1994021202A1 (fr) * 1993-03-19 1994-09-29 Packard Development S.A. Dispositif de traitement medical
WO1998029068A1 (fr) * 1996-12-31 1998-07-09 Gynecare, Inc. Ballonnet chauffe dote d'un agitateur de fluide a mouvement alternatif

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7156860B2 (en) 2000-05-26 2007-01-02 Wallsten Medical S.A. Balloon catheter
WO2002064070A1 (fr) * 2001-02-09 2002-08-22 Wallsten Medical S.A. Catheter a ballonnet et methode de traitement d'un conduit ou d'une cavite de mammifere par pression ou chaleur
CN117563113A (zh) * 2024-01-15 2024-02-20 上海玄宇医疗器械有限公司 推杆调节机构及其球囊导管
CN117563113B (zh) * 2024-01-15 2024-04-09 上海玄宇医疗器械有限公司 推杆调节机构及其球囊导管

Also Published As

Publication number Publication date
SE9702984D0 (sv) 1997-08-19
AU8654898A (en) 1999-03-08

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