WO2009001326A1 - Système d'ablation, dispositif et procédé servant à effectuer l'ablation de matière dans une lumière ou une cavité - Google Patents

Système d'ablation, dispositif et procédé servant à effectuer l'ablation de matière dans une lumière ou une cavité Download PDF

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Publication number
WO2009001326A1
WO2009001326A1 PCT/IE2008/000068 IE2008000068W WO2009001326A1 WO 2009001326 A1 WO2009001326 A1 WO 2009001326A1 IE 2008000068 W IE2008000068 W IE 2008000068W WO 2009001326 A1 WO2009001326 A1 WO 2009001326A1
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WO
WIPO (PCT)
Prior art keywords
expandable element
ablating
balloon
sectional area
transverse cross
Prior art date
Application number
PCT/IE2008/000068
Other languages
English (en)
Inventor
John O'dea
Adrian Mchugh
Patrick Griffin
Original Assignee
Flip Technologies Limited
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 Flip Technologies Limited filed Critical Flip Technologies Limited
Publication of WO2009001326A1 publication Critical patent/WO2009001326A1/fr

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Classifications

    • 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
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart 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
    • A61B2018/00053—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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A61B2018/0025—Multiple balloons
    • A61B2018/00261—Multiple balloons arranged in a line
    • 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
    • A61B2018/00482—Digestive system
    • A61B2018/00494—Stomach, intestines or bowel
    • 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
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters

Definitions

  • the present invention relates to an ablation device and a method for ablating a matter in a lumen or a cavity, and in particular, though not limited to a method and a device for ablating tissue in a hollow organ in a human or animal subject, for example, an oesophagus, a colon, an intestine, a urethra, and the like.
  • the invention also relates to an ablation system for ablating matter in a lumen or a cavity.
  • RF radio frequency
  • An example of a device which uses high power radio frequency energy in such a procedure is the Barrx Halo 360 system which is described in U.S. Patent Specification No. 6,551 ,310.
  • a radio frequency ablation element is located on the surface of a balloon, namely, an ablation balloon, which in turn is located at the distal end of a catheter.
  • the balloon compresses the ablation element against the surface to be ablated.
  • a separate balloon namely, a sizing balloon is placed at the bottom of the oesophagus and is drawn upwardly through the oesophagus.
  • This information is used to assist with the subsequent placement of the ablation balloon.
  • the present invention is directed towards providing a method and a device which addresses at least some of the problems of known ablation devices, and the invention is also directed towards providing a method and a device for ablating matter in a lumen or a cavity, be it a biological lumen or cavity or a non-biological lumen or cavity.
  • the invention is further directed towards providing an ablation system for ablating matter from a lumen or a cavity.
  • an ablation device for ablating matter in one of a lumen and a cavity
  • the ablation device comprising a catheter extending between a proximal end and a distal end, an expandable element located on the catheter adjacent the distal end thereof, with the catheter extending through the expandable element, an ablating means carried on the expandable element, a means for facilitating expanding of the expandable element for urging the ablating means into engagement with the matter to be ablated, and a means for facilitating determining the transverse cross-sectional area of the expandable element.
  • the expandable element comprises an inflatable balloon defining a hollow interior region through which the catheter extends, the balloon having an outer surface, and the ablating means being located on the outer surface of the balloon.
  • the balloon when inflated is adapted to adopt a cylindrical configuration having a longitudinally extending peripheral surface on which the ablating means is located.
  • the means for facilitating expanding of the balloon comprises an inflating medium accommodating means communicating the hollow interior region of the balloon with the exterior thereof for accommodating an inflating medium from an inflating medium source to the hollow interior region of the balloon.
  • the inflating medium accommodating means comprises an axial inflating bore extending axially through the catheter from the proximal end thereof to at least one radial inflating bore extending radially from the axial inflating bore through the catheter within the hollow interior region of the balloon.
  • the means for facilitating determining the transverse cross-sectional area of the expandable element is located within the hollow interior region of the balloon.
  • the means for facilitating determining the transverse cross-sectional area of the expandable element comprises at least two axially spaced apart measuring electrodes located on one of an inner surface of the balloon and an outer surface of the catheter within the hollow interior region of the balloon for facilitating determining of the transverse cross-sectional area of the balloon when the balloon is inflated with an electrically conductive medium.
  • a first electrically conductive communicating means is provided for communicating the measuring electrodes with electronic control and analysis apparatus externally of the balloon.
  • the first electrically conductive communicating means comprises a plurality of mutually insulated electrically conductive first wires extending from the respective measuring electrodes externally of the hollow interior region of the balloon.
  • the electrically conductive first wires extend through an axial communicating bore extending axially through the catheter from the proximal end thereof to a location adjacent the electrodes.
  • at least one radial communicating opening extends radially through the catheter from the axial communicating bore within the hollow interior region of the balloon for accommodating the first wires therefrom to the respective measuring electrodes.
  • a plurality of the radial communicating openings are provided for the respective first wires.
  • one first wire is provided to each measuring electrode.
  • the measuring electrodes are located on the outer surface of the catheter.
  • At least one of the measuring electrodes is a stimulating electrode for receiving one of a stimulating voltage signal and a stimulating current signal
  • at least one of the measuring electrodes is a receiving electrode for producing a resulting signal in response to the one of the stimulating voltage signal and the stimulating current signal when the balloon is inflated with an electrically conductive medium, the resulting signal being indicative of one of the transverse cross-sectional area and the diameter of the balloon adjacent the corresponding one of the at least one receiving electrode.
  • a pair of axially spaced apart stimulating electrodes are provided, and a plurality of axially spaced apart receiving electrodes are located between the stimulating electrodes and axially spaced apart therefrom.
  • the first wires are connected to the respective receiving electrodes so that the voltage difference between the voltage on at least one of the stimulating electrodes and each receiving electrode is determinable.
  • the first wires are connected to the respective receiving electrodes so that the voltage difference between the voltage on adjacent ones of the receiving electrodes is determinable.
  • the ablating means comprises at least one ablating electrode located on the outer surface of the balloon.
  • a plurality of axially spaced apart ablating electrodes are provided on the outer surface of the balloon.
  • a second electrically conductive communicating means is provided for communicating the ablating electrodes with the proximal end of the catheter.
  • the second electrically conductive communicating means comprise a plurality of mutually insulated electrically conductive second wires for coupling to the respective ablating electrodes.
  • one electrically conductive second wire is provided for each ablating electrode.
  • a plurality of radial bores extend radially through the balloon for sealably accommodating the respective second wires therethrough to the ablating electrodes from the hollow interior region of the balloon.
  • the second wires are accommodated through the axial communicating bore extending through the catheter from the proximal end thereof.
  • the second wires are accommodated through the at least one radial communicating opening in the catheter from the axial communicating bore to the hollow interior region of the balloon.
  • the second wires are accommodated through respective ones of the radial communicating opening in the catheter.
  • the second wires extend along the outer surface of the balloon from the ablating electrodes to the axial communicating bore extending through the catheter and access the axial communicating bore externally of the balloon.
  • the second electrically conductive communicating means is adapted for coupling to a power source for selectively applying a power signal to the ablating electrodes.
  • the expandable element comprises at least two adjacent inflatable balloons defining respective hollow interior regions through which the catheter extends, and the ablating means is located on at least one of the balloons.
  • an ablating means is located on the outer surface of each balloon.
  • the respective balloons are inflatable independently of each other.
  • the axial length of the respective balloons is substantially similar.
  • the axial length of one of the balloons is different to the axial length of at least another one of the balloons.
  • a centre one of the balloons is of axial length greater than the axial length of the other balloons when the said centre and other balloons are inflated.
  • each balloon comprises a means for facilitating determining the transverse cross-sectional area of the balloon.
  • the ablation device is adapted for ablating matter in a biological lumen or a hollow biological organ.
  • the ablation device is adapted for ablating one of cancerous tissue and precancerous tissue from a hollow biological organ.
  • the ablation device is adapted for ablating the one of the cancerous tissue and the precancerous tissue from one of an oesophagus, a colon, an intestine and a urethra.
  • the ablation device is adapted for ablating one of a stricture and an occlusion from a hollow biological organ.
  • the ablation device is adapted for ablating one of a stricture and an occlusion from one of an oesophagus, a colon, an intestine and a urethra.
  • the invention also provides a method for ablating matter in one of a lumen and a cavity, the method comprising inserting the ablation device as claimed in any preceding claim into the lumen or cavity with the distal end of the catheter as the leading end, partially expanding the expandable element when the expandable element is located in the lumen or the cavity, and urging the catheter and the expandable element along the lumen or the cavity until the expandable element is axially centrally located relative to the matter to be ablated, determining the transverse cross-sectional area of the expandable element as the expandable element is being urged through the lumen or cavity for identifying the location of the matter to be ablated, expanding the expandable element to urge the expandable element and the ablating means into engagement with the matter to be ablated, and applying a signal
  • the invention provides a method for ablating matter in one of a lumen and a cavity comprising providing a catheter extending between a proximal end and a distal end, providing an expandable element located on the catheter adjacent the distal end thereof, with the catheter extending through the expandable element, providing an ablating means on the expandable element, providing a means for facilitating determining the transverse cross-sectional area of the expandable element, the method further comprising inserting the catheter into the lumen or the cavity with the distal end of the catheter as the leading end, partially expanding the expandable element in the lumen or the cavity, urging the catheter and the expandable element along the lumen or the cavity until the expandable element is axially centrally located relative to the matter to be ablated, determining the transverse cross-sectional area of the expandable element as the expandable element is being urged through the lumen for identifying the location of the matter to be ablated, expanding the expandable element to urge the expandable element and the ablating means into engagement with the matter to be
  • the signal applied to the ablating means is a high energy radio frequency signal.
  • the signal is applied to the ablating means until the matter has been ablated.
  • the transverse cross-sectional area of the expandable element adjacent its respective axially opposite ends is determined for determining the transverse cross-sectional area of the interior or the cavity of the lumen adjacent the respective axial opposite ends of the matter to be ablated.
  • the transverse cross-sectional area to which the expandable element is to be expanded for urging the ablating means into engagement with the matter to be ablated is determined as a function of the transverse cross-sectional area of the expandable element adjacent its respective axial opposite ends.
  • the method further comprises reading the signals indicative of the one of the transverse cross-sectional area and the diameter of the balloon from the means for facilitating determining the transverse cross- sectional area of the expandable element, and converting the signals into a visual graphical representation representative of a longitudinal cross-section of the balloon.
  • the method further comprises reading the signals indicative of the one of the transverse cross-sectional area and the diameter of the balloon from the means for facilitating determining the transverse cross- sectional area of the expandable element, and converting the signals into a visual image representative of the balloon.
  • the signals indicative of the one of the transverse cross-sectional area and the diameter of the balloon read from the means for facilitating determining of the transverse cross-sectional area of the balloon are converted to approximate values of the diameter of the balloon at the respective axially spaced apart locations and displayed.
  • the signals indicative of the diameter of the balloon at the axially spaced apart locations are derived by determining the voltage difference between the at least one receiving electrode and at least one of the stimulating electrodes of the means for facilitating determining the transverse cross-sectional area of the expandable element.
  • the signals indicative of the diameter of the balloon at the axially spaced apart locations are derived by determining the voltage difference between each receiving electrode and at least one of the stimulating electrodes of the means for facilitating determining the transverse cross-sectional area of the expandable element.
  • the signals indicative of the diameter of the balloon at the axially spaced apart locations are derived by determining the voltage difference between adjacent ones of the receiving electrodes of the means for facilitating determining the transverse cross-sectional area of the expandable element.
  • the invention also provides a method for ablating matter in a hollow biological organ comprising providing a catheter extending between a proximal end and a distal end, providing an expandable element located on the catheter adjacent the distal end thereof, with the catheter extending through the expandable element, providing an ablating means on the expandable element, providing a means for facilitating determining the transverse cross-sectional area of the expandable element, the method further comprising inserting the catheter into the hollow biological organ with the distal end of the catheter as the leading end, partially expanding the expandable element in the hollow biological organ, urging the catheter and the expandable element along the hollow biological organ until the expandable element is axially centrally located relative to the matter to be ablated, determining the transverse cross-sectional area of the expandable element as the expandable element is being urged through the hollow biological organ for identifying the location of the matter to be ablated, expanding the expandable element to urge the expandable element and the ablating means into engagement with the matter to be ablated, and applying a signal
  • the method is adapted for ablating one of cancerous tissue and precancerous tissue in any one of the following organs: an oesophagus, a colon, an intestine, a urethra.
  • the method is adapted for ablating one of a stricture and an occlusion in any one of the following organs: an oesophagus, a colon, an intestine, a urethra.
  • the ablating means is adapted for ablating the one of the stricture and the occlusion formed by tissue.
  • the ablating means is adapted for ablating diseased tissue.
  • the invention also provides an ablation system for ablating matter in one of a lumen and a cavity, the ablation system comprising the ablation device according to the invention, a display means for displaying an image representative of an outer surface of the expandable element, and a means for converting the signals indicative of the one of the transverse cross-sectional area and the diameter of the expandable element to an electronic form of the image to be displayed on the visual display screen.
  • the invention further provides a system for ablating matter in one of a lumen and a cavity, the system comprising an ablation device comprising a catheter extending between a proximal end and a distal end, an expandable element located on the catheter adjacent the distal end thereof, with the catheter extending through the expandable element, an ablating means carried on the expandable element, a means for expanding the expandable element for urging the ablating means into engagement with the matter to be ablated, a means for determining the transverse cross-sectional area of the expandable element and for producing signals indicative of the transverse cross-sectional area thereof, a means for converting the signals indicative of the transverse cross-sectional area of the expandable element to signals indicative of an image representative of the expandable element, and a display means for displaying the image representative of the expandable element.
  • an ablation device comprising a catheter extending between a proximal end and a distal end, an expandable element located on the catheter adjacent the distal end thereof, with the catheter
  • the means for converting the signals indicative of the transverse cross- sectional area of the expandable element to signals representative of an image of the expandable element produces the signals indicative of a three-dimensional image representative of the expandable element.
  • the means for converting the signals indicative of the transverse cross-sectional area of the expandable element to signals representative of the expandable element produces the signals indicative of an image representative of a longitudinal cross-sectional profile of the expandable element.
  • the means for determining the transverse cross-sectional area of the expandable element and for producing signals indicative of the transverse cross- sectional area of the expandable element produces signals indicative of the transverse cross-sectional area of the expandable element at axially spaced apart locations along the expandable element.
  • the means for determining the transverse cross-sectional area of the expandable element and for producing signals indicative of the transverse cross- sectional area of the expandable element produces signals indicative of approximate values of the diameter of the expandable element at the axially spaced apart locations.
  • the display means displays the approximate values of the diameter of the expandable element.
  • the invention also provides for use of the ablation device according to the invention for ablating matter in one of a biological lumen and a hollow biological organ.
  • the invention also provides for use of the ablation device according to the invention for ablating one of cancerous tissue and precancerous tissue from a hollow biological organ.
  • the invention also provides for use of the ablation device according to the invention for ablating one of cancerous tissue and precancerous tissue from one of an oesophagus, a colon, an intestine and a urethra.
  • the invention also provides for use of the ablation device according to the invention for use in ablating one of a stricture and an occlusion in a hollow biological organ.
  • the invention also provides for use of the ablation device according to the invention for ablating one of a stricture and an occlusion in one of an oesophagus, a colon, an intestine and a urethra.
  • the invention also provides for use of an ablation system according to the invention for ablating matter in one of a biological lumen and a hollow biological organ.
  • the invention also provides for use of the ablation system according to the invention for ablating one of cancerous tissue and precancerous tissue from a hollow biological organ.
  • the invention also provides for use of the ablation system according to the invention for ablating one of cancerous tissue and precancerous tissue from one of an oesophagus, a colon, an intestine and a urethra.
  • the invention also provides for use of the ablation system according to the invention for use in ablating one of a stricture and an occlusion in a hollow biological organ.
  • the invention also provides for use of the ablation system according to the invention for ablating one of a stricture and an occlusion in one of an oesophagus, a colon, an intestine and a urethra.
  • the advantages of the ablation system and device, as well as the ablation method according to the invention are many.
  • a particularly important advantage of the ablation system and device is that it permits a relatively accurate representation of a portion of the lumen in which the device is located to be presented, so that a surgeon can readily identify the matter such as a stricture or an occlusion, as well as cancerous and precancerous tissue to be ablated in the lumen or the cavity, for example, in the oesophagus, and can thus readily easily manoeuvre the ablation device so that the ablation device is aligned with the stricture, occlusion, cancerous tissue or precancerous tissue to be ablated.
  • the expandable element of the device is provided in the form of one or more balloons with ablating means located on an outer surface of the balloon or balloons
  • the degree to which the balloon or balloons adjacent the stricture, occlusion, cancerous or precancerous tissue is inflated for urging the ablating means into engagement with the matter to be ablated can be readily observed on a visual display screen or other suitable display means, thereby allowing the surgeon to determine when the ablating means has been urged to the desired degree into engagement with the matter to be ablated.
  • the provision of the stimulating and receiving electrodes within the hollow interior of the balloon or balloons provides a particularly important advantage in that it permits the transverse cross-sectional area, and thus the diameter of the balloon or balloons at a plurality of axially spaced apart locations to be accurately determined. Additionally, by accurately determining the diameter of the balloon or balloons at the respective axially spaced apart locations, the diameter of the lumen or cavity adjacent respective axially opposite ends of the matter to be ablated can be readily determined when the balloon has been inflated to tightly abut the lumen or cavity, and additionally, the diameter of the matter to be ablated can also be readily determined. Furthermore, the diameter to which the balloon should be inflated adjacent the matter to be ablated in order to urge the ablating means into engagement with the matter to the appropriate degree can readily be determined from the respective diameters.
  • the device and the system according to the invention determines the diameter of the lumen or cavity as the expandable element is being urged through the lumen or cavity, the location of the matter to be ablated is readily identifiable, and therefore there is no need for a measuring balloon to be passed into the lumen or cavity prior to the device according to the invention being passed into the lumen or cavity, and thus a single device, namely, the device according to the invention is all that is required.
  • Fig. 1 is a transverse cross-sectional side elevational view of an ablation device according to the invention
  • Fig. 2 is an end elevational view of the ablation device of Fig. 1,
  • Fig. 3 is a block representation of an ablation system also according to the invention which comprises the ablation device of Fig. 1 ,
  • Fig. 4 is a diagrammatic view of the ablation device of Fig. 1 , in use,
  • Fig. 5 is another diagrammatic view of the ablation device of Fig. 1 in use
  • Fig. 6 is a block representation of the ablation system according to another embodiment of Fig. 1 .
  • Fig. 7 is a transverse cross-sectional side elevational view of an ablation device according to another embodiment of the invention.
  • Fig. 8 is a transverse cross-sectional side elevational view of an ablation device according to a further embodiment of the invention.
  • an ablation system for ablating matter in a lumen or a cavity.
  • the ablation system 1 is particularly suitable for ablating tissue 100, for example, cancerous tissue or precancerous tissue, which may or may not cause a stricture or an occlusion in, for example, the oesophagus 101 of a human or animal subject, and in particular, in a human subject.
  • the ablation system 1 comprises an ablation device also according to the invention and indicated generally by the reference numeral 2 for inserting into the oesophagus 101 for ablating the tissue 100.
  • a visual display screen 3 receives signals which are converted from signals from the ablation device 2 as will be described below for displaying a three-dimensional image which is representative of the oesophagus 101 adjacent the tissue 100 to be ablated.
  • the ablation device 2 comprises an elongated catheter 4 extending from a proximal end 5 to a distal end 6 for inserting into the oesophagus 101 nasally or orally.
  • An expandable element namely, an inflatable balloon 7 defining a hollow interior region 8 is located on the catheter 4 adjacent the distal end 6 thereof with the catheter 4 extending through the hollow interior region 8 thereof.
  • the balloon 7 when inflated is of cylindrical configuration and defines a central longitudinally extending balloon axis 9 which coincides with a longitudinally extending central axis 10 of the catheter 4.
  • the balloon 7 at its respective axially opposite ends 11 and 12 is sealably secured to the catheter 4, and is provided thereon for locating adjacent the tissue 100 to be ablated in the oesophagus 101 as will be described below.
  • a means for facilitating expanding the balloon 7 comprises an inflating medium accommodating means, which in this embodiment of the invention is provided by an elongated axial inflating bore 14 extending longitudinally through the catheter 4 from the proximal end 5 to the distal end 6 thereof for accommodating an inflating medium, which in this case is an electrically conductive medium, preferably, a saline solution, for inflating the balloon 7.
  • a plurality of radial inflating bores 15 extend radially through the catheter 4 within the hollow interior region 8 of the balloon 7 and communicate with the axial inflating bore 14 for accommodating the inflating medium between the axial inflating bore 14 and the hollow interior region 8 of the balloon 7.
  • the catheter 4 terminates at its distal end 6 in a hemispherical plug 16, which sealably closes the distal end of the axial inflating bore 14.
  • An ablating means for ablating the tissue 100 in the oesophagus 101 in this embodiment of the invention comprises a plurality of axially spaced apart band type ablating electrodes 18 located on an outer surface 19 of the balloon 7 and extending completely circumferentially around the balloon 7.
  • a means for facilitating determining the transverse cross-sectional area of the balloon 7 at a plurality of axially spaced apart locations comprises a plurality of electrically conductive measuring electrodes, namely, a pair of electrically conductive stimulating electrodes 20 and a plurality of electrically conductive receiving electrodes 21 located spaced apart axially on an outer surface 23 of the catheter 4 within the hollow interior region 8 of the balloon 7.
  • the stimulating electrodes 20 are located on the outer surface 23 of the catheter 4 adjacent the respective axially opposite ends 11 and 12 of the hollow interior region 8 of the balloon 7 for receiving a stimulating voltage signal or a stimulating current signal, which in this case is a stimulating current signal of known constant value.
  • the receiving electrodes 21 which in this case comprise ten receiving electrodes 21 are located axially spaced apart on the outer surface 23 of the catheter 4 between and spaced apart from the stimulating electrodes 20.
  • the stimulating electrodes 20 and the receiving electrodes 21 are provided by electrically conductive band electrodes which extend completely circumferentially around and are bonded to the catheter 4.
  • the receiving electrodes 21 are equi- spaced axially from each other, and the stimulating electrodes 20 are spaced apart axially from the adjacent receiving electrodes 21 a similar distance as that of the spacing between adjacent ones of the receiving electrodes 21
  • the receiving electrodes 21 may or may not be equi-spaced apart axially from each other, and the spacing between the stimulating electrodes 20 and the adjacent receiving electrodes 21 may or may not be similar to the spacing between the receiving electrodes 21.
  • the receiving electrodes 21 may preferably be more closely spaced apart along the axial central portion of the catheter 4 within the hollow interior region 8 of the balloon 7, and spaced apart at greater axial distance towards the axial opposite ends 11 and 12 of the balloon 7.
  • the number and spacing of the receiving electrodes will depend on the axial length of the balloon and the resolution required of the image thereof on the visual display screen 3.
  • a first electrically conductive communicating means for applying the stimulating current signal to the stimulating electrodes 20 and for receiving resulting voltage signals from the receiving electrodes 21 when the balloon 7 is inflated with the saline solution comprises a plurality of mutually insulated electrically conductive first wires 24 which extend through a first communicating means, namely, a longitudinally extending axial communicating bore 25 which extends through the catheter 4 from the proximal end 5 to the distal end 6 thereof.
  • the plug 16 sealably closes the axial communicating bore 25 at the distal end 6 thereof.
  • a plurality of radial communicating openings 26 extending radially through the catheter 4 and communicating with the axial communicating bore 25 accommodate the respective first wires 24 from the axial communicating bore 25 to the corresponding one of the stimulating and receiving electrodes 20 and 21.
  • the first wires 24 are electrically insulated, and a separate first wire 24 is provided to each stimulating electrode 20 and each receiving electrode 21.
  • the first wires 24 extend from the axial communicating bore 25 at the proximal end 5 thereof for coupling to electronic control and analysing apparatus 27 described in detail below for facilitating determining the diameter of the balloon 7 at axially spaced apart locations adjacent the receiving electrodes 21.
  • An inflating means namely, a pump 30 is connected to the axial inflating bore 14 of the catheter 4 adjacent the proximal end 5 thereof via a conduit 31 and to a reservoir 32 of saline solution by a conduit 33 for pumping the saline solution between the reservoir 32 and the hollow interior region 8 of the balloon 7 for inflating and deflating thereof.
  • a pressure monitoring means comprising a pressure sensor and a pressure gauge 34 is located in the conduit 31 for facilitating monitoring of the pressure to which the balloon 7 is inflated.
  • a second electrically conductive communicating means for communicating the ablating electrodes 18 with the electronic control and analysing apparatus 27 comprises a plurality of mutually insulated electrically conductive second wires 35 which are coupled to the ablating electrodes 18.
  • a plurality of radial bores 36 which extend radially through the balloon 7 accommodate respective ones of the second wires 35 from the ablating electrodes 18 into the hollow interior region 8 of the balloon 7.
  • the second wires 35 are electrically insulated, and one second wire 35 is provided to each ablating electrode 18.
  • the second wires 35 are accommodated through appropriate ones of radial communicating openings 26 into the axial communicating bore 25 in the catheter 4, and in turn to the control and analysing apparatus 27.
  • the length of the second wires 35 extending between the radial communicating openings 26 in the catheter 4 and the corresponding radial bores 36 in the balloon 7 is such as to facilitate inflating of the balloon 7 to its maximum diameter.
  • the second wires 35 may extend from the ablating electrodes 18 along the outer surface of the balloon 7 to the proximal end 11 of the balloon 7, and the second wires 35 would enter the axial communicating bore 25 through a radial bore in the catheter 4 external of the balloon 7.
  • the ablating electrodes 18 are adapted for receiving high power radio frequency signals which are produced by the control and analysing apparatus 27 for ablating the tissue 100.
  • the control and analysing apparatus 27 comprises a radio frequency signal generator 39 for generating appropriate high power radio frequency signals which are applied to the ablating electrodes 18 through the second wires 35.
  • a control circuit 40 controls the radio frequency signal generator 39 to produce the high power radio frequency signals at an appropriate level.
  • radio frequency generators and control circuits will be well known to those skilled in the art.
  • control and analysing apparatus 27 comprises a constant current generator 42 for generating and applying the stimulating current signal across the stimulating electrodes 20 through two of the corresponding first wires 24 which are coupled to the stimulating electrodes 20.
  • Ten analogue-to-digital converters 43 in the control and analysing apparatus 27 are coupled by corresponding ones of the first wires 24 to corresponding ones of receiving electrodes 21 for converting the respective resulting analogue voltage signals on the receiving electrodes 21 resulting from the stimulating current signal applied to the stimulating electrodes 20 to corresponding digital values.
  • a control means in this case a microprocessor 45 of the control and analysing apparatus 27 reads the digital values from the analogue-to-digital converters 43 corresponding to the voltage signals on the receiving electrodes 21 and computes the transverse cross-sectional areas and in turn the diameters of the balloon 7 at the axially spaced apart locations corresponding to the locations of the receiving electrodes 21. Signals indicative of the computed diameters are applied to a graphics processor 46, which produces signals indicative of a three-dimensional image 47 which is representative of the balloon 7 which is displayed on the visual display screen 3.
  • the approximate numerical values of diameters of the balloon 7 at the axially spaced apart locations corresponding to the locations of the receiving electrodes 21 are displayed on the visual display screen 3 in windows 48 along with the image 47 and adjacent the respective locations corresponding to the receiving electrodes 21.
  • the image 47 representative of the balloon 7 and the displayed diameter values in the windows 48 on the visual display screen 3 when the balloon 7 is abutting the oesophagus are representative of a three-dimensional image and the corresponding diameters of the portion of the oesophagus 101 adjacent the balloon 7.
  • a doctor or a surgeon operating the ablating device 1 can readily identify from the image 47 on the visual display screen 3 when the balloon 7 is centrally aligned with the tissue 100 to be ablated, and also can read the diameter of the tissue 100 as well as the diameter of the oesophagus 101 on respective axial opposite ends of the tissue 100 from the screen 3.
  • the microprocessor 45 computes the approximate values of the diameters of the balloon 7 adjacent the axially spaced apart locations corresponding to the receiving electrodes 21 by detecting the drop in voltage between the stimulating electrodes 20 and the corresponding receiving electrodes 21 and the voltage drop between adjacent ones of the receiving electrodes 21 when the balloon 7 is inflated with the saline solution and the stimulating current signal is applied across the stimulating electrodes 20.
  • the drop in the voltage between the stimulating electrodes 20 and the receiving electrodes 21 and between adjacent ones of the receiving electrodes 21 is a function of the electrical impedance of the saline solution between the stimulating electrodes 20 and the receiving electrodes 21 and between the adjacent ones of receiving electrodes 21 , respectively, and since the electrical impedance of the saline solution is a function of the volume of saline solution between the stimulating electrodes 20 and the receiving electrodes 21 and the adjacent ones of the receiving electrodes 21, respectively, the transverse cross- sectional area and in turn the diameter of the balloon 7 adjacent the respective receiving electrodes 21 is a function of the voltage drops between the stimulating electrodes 20 and the receiving electrodes 21 and between the adjacent ones of receiving electrodes 21.
  • the microprocessor 45 is programmed to determine the approximate values of the diameter of the balloon 7 from the respective voltage drops, and outputs signals indicative of the approximate values of the diameter to the graphics processor 46 which produces signals indicative of a three-dimensional image representative of the balloon 7, which in turn is displayed on the visual display screen 3.
  • the microprocessor 45 also controls the operation of the pump 30 for inflating and deflating the balloon 7, the constant current generator 42 for applying the stimulating signals to the stimulating electrodes 20, and the control circuit 40 for operating the radio frequency signal generator 39. Additionally, the microprocessor 45 reads signals from the pressure sensor and pressure gauge 34 for determining the pressure to which the balloon 7 is inflated by the saline solution.
  • the distal end 6 of the catheter 4 with the balloon 7 deflated is entered into the oesophagus 101 either nasally or orally and is manoeuvred until the balloon 7 is in the general area of the tissue 100 to be ablated.
  • the balloon 7 is then partially inflated with the saline solution by the pump 30 under the control of the microprocessor 45.
  • the constant current generator 42 is operated under the control of the microprocessor 45 to apply the stimulating current signal to the stimulating electrodes 20.
  • Digital values of the resulting voltage signals on the receiving electrodes 21 are read by the microprocessor 45 from the corresponding analogue-to-digital converters 43.
  • the microprocessor 45 computes the approximate values of the diameter of the balloon 7 at the axially spaced apart locations adjacent the receiving electrodes 21 from the voltage values, and continuously updates the graphics processor 46 with the diameter values of the balloon 7 at the locations corresponding to the receiving electrodes 21.
  • the graphics processor 46 in turn continuously updates the image 47 representative of the balloon 7 on the visual display screen 3, and also updates the diameter values of the balloon 7 displayed in the windows 48 on the visual display screen 3. This, thus, gives the surgeon or doctor an indication of the location of the balloon 7 relative to the tissue 100 to be ablated.
  • the balloon 7 With the balloon 7 partially inflated, the balloon 7 is moved slowly along the oesophagus while watching the visual display screen 3 in order to identify when the balloon 7 is axially centrally located relative to the tissue 100 to be ablated.
  • the balloon 7 is further inflated with the saline solution until the outer surface 19 of the balloon 7 is tightly abutting the oesophagus 101 for determining the diameter of the oesophagus 101 at the respective axial opposite ends of the tissue 100, which is read from the visual display screen 3.
  • the pressure of the saline solution is monitored on the pressure sensor and the pressure gauge 34 by the microprocessor 45 to identify when the balloon 7 has been inflated to a stage where it is tightly abutting the oesophagus 101.
  • An increase in the rate at which the pressure in the saline solution is increasing, or a sudden increase in the pressure in the saline solution is indicative of the balloon 7 being in tight abutment with the oesophagus 101.
  • the surgeon or doctor determines the desired pressure and diameter to which the balloon 7 should be inflated in order to urge the ablating electrodes 18 into engagement with the tissue 100 to be ablated with the appropriate pressure.
  • the surgeon or doctor then continues to inflate the balloon 7, while monitoring the diameter of the balloon 7 adjacent the tissue 100 from the screen 3 until the balloon 7 in the area of the tissue 100 has been inflated to the desired diameter.
  • the control circuit 40 under the control of the microprocessor 45 is then operated for in turn activating and operating the radio frequency signal generator 39 to produce the high power radio frequency signals at the desired frequency and energy level.
  • the radio frequency signals are applied to the ablating electrodes 18 through the second wires 35 for an appropriate time period for ablating the tissue 100.
  • the microprocessor 45 On completion of ablation of the tissue 100, the microprocessor 45 operates the control circuit 40 to deactivate the radio frequency signal generator 39 and also deactivates the constant current generator 42. The microprocessor 45 then operates the pump 30 for pumping the saline solution from the balloon 7 to the reservoir 32 to in turn deflate the balloon 7. With the balloon 7 deflated, the catheter 4 and the balloon 7 are removed from the oesophagus.
  • An alternative method for axially centrally locating the balloon 7 relative to the tissue 100 to be ablated is to consecutively and alternatively inflate and deflate the balloon 7 with the saline solution, and incrementally urge the balloon 7 along the oesophagus 101 between each inflation and deflation thereof, until the balloon 7 is eventually located centrally axially relative to the tissue 100 to be ablated.
  • the microprocessor 45 operates the constant current generator 42 for applying the stimulating current signal to the stimulating electrodes 20, and the microprocessor 45 reads the outputs of the analogue-to-digital converters 43, and in turn determines the approximate values of the diameter of the balloon 7 at the locations adjacent the receiving electrodes 21 , and outputs the diameter values to the graphics processor 46.
  • the graphics processor 46 continuously updates the three-dimensional image 47 representative of the balloon 7 on the visual display screen 3 as well as the diameter values in the windows 48 on the visual display screen 3. This, thus, permits a doctor or surgeon to determine from the image 47 displayed on the visual display screen 3 when the balloon 7 is axially centrally aligned with the tissue 100 to be ablated.
  • FIG. 6 there is illustrated a circuit diagram of an ablation system according to another embodiment of the invention, indicated generally by the reference numeral 50.
  • the ablation system 50 is substantially similar to the ablation system 1 , and similar components are identified by the same reference numerals.
  • the only difference between the ablation system 50 and the ablation system 1 is in the control and analysing circuit 27.
  • the voltages on the receiving electrodes 21 are differentially applied to the analogue-to-digital converters 43 through differential op-amps 51.
  • the inverting and non-inverting inputs of the op-amps 51 are coupled to respective corresponding adjacent ones of receiving electrodes 21, and the outputs of the op-amps 51 which are indicative of the voltage difference between the respective corresponding adjacent ones of receiving electrodes 21 are applied to the respective corresponding analogue-to- digital converters 43, which convert the analogue voltage difference values to digital values.
  • the microprocessor 45 reads the outputs of the analogue-to-digital converters 43 and determines the diameter of the balloon 8 at the locations corresponding to the respective receiving electrodes 21. Otherwise, the ablation system 50 and its operation is similar to that of the ablation system 1 described with reference to Figs. 1 to 5.
  • an ablation device indicated generally by the reference numeral 60, according to another embodiment of the invention for use with the ablation systems 1 or 50 for ablating tissue 100, also in the oesophagus 101.
  • the ablation device 60 is substantially similar to the ablation device 2, and similar components are identified by the same reference numerals.
  • the main difference between the ablation device 60 and the ablation device 2 is that instead of the expandable element of the ablation device 60 being provided with one single balloon adjacent the distal end 6 of the catheter 4, the expandable element comprises six balloons 61 located side by side on the catheter 4 adjacent the distal end 6 with the catheter 4 extending through the six balloons 61.
  • Each balloon 61 is independently inflatable relative to the other balloons 61 , and accordingly, six mutually isolated axial inflating bores 14, only one of which is illustrated, extend through the catheter 4 and communicate with the hollow interior regions 8 of the respective corresponding balloons 61 through corresponding radial inflating bores 15 for independently inflating the balloons 61 relative to each other.
  • the balloons 61 each carry a pair of ablating electrodes 18, and the ablating electrodes 18 of the respective balloons 61 are independently controllable relative to the ablating electrodes 18 of the other balloons 61.
  • each of the six balloons 61 two axially spaced apart stimulating electrodes 20 are located on the catheter 4 and one receiving electrode 21 equi-spaced axially from the stimulating electrodes 20 is located between the stimulating electrodes 20.
  • a corresponding number of mutually insulated first wires 24 extend through the axial communicating bore 25 and the radial communicating openings 26 in the catheter 4 to stimulating and receiving electrodes 20 and 21.
  • a corresponding number of second wires 35 are provided through the axial communicating bore 25 and the radial communicating openings 26 to the ablating electrodes 18.
  • Seals (not shown) in the radial communicating openings 26 form watertight seals between the first and second wires 24 and 35 and the catheter 4, in order to maintain the integrity of the isolation between the axial inflating bores 15 and in turn the integrity of the isolation between the hollow interior regions 8 of the balloons 61 , so that the balloons 61 are independently inflatable and deflatable, relative to each other.
  • each of the six balloons 61 are identical in size and shape, and each when inflated are of cylindrical configuration.
  • the ablation device 60 is substantially similar to use of the ablation device 1.
  • the respective balloons 61 are simultaneously inflated with the saline solution.
  • a stimulating current signal is applied to the stimulating electrodes 20 in the respective balloons 61 , and the voltages on the receiving electrodes 21 are applied to the analogue-to-digital converters 43 of the control and analysing apparatus 27.
  • the microprocessor 45 continuously computes approximate values of the diameters of the respective balloons 61 from the digital values of the voltages read from the analogue-to-digital converters adjacent the respective receiving electrodes 21 , and the graphics processor 46 continuously updates the image 47 representative of the balloons 61 on the visual display screen 3, as well as the diameter values of the respective balloons 61 which are also displayed in the windows on the visual display screen 3.
  • the diameters of the balloons 61 adjacent the axially opposite ends of the tissue 100 to be ablated is read from the visual display screen 3, and the amount by which the balloons 61 which are centrally aligned with the tissue 100 are to be inflated to urge the ablating electrodes 18 thereon into engagement with the tissue 100 at the appropriate pressure for carrying out the ablation of the tissue 100 is determined from the diameters of the oesophagus 101 at the respective axial opposite ends of the tissue 100.
  • the pump 30 is operated for pumping the saline solution through a valving system (not shown) to the balloons 61 adjacent the tissue 100 to be ablated, and the microprocessor 45 from the voltage signals on the receiving electrodes 21 in the balloons 61 being inflated continuously determines the diameters of those balloons which are displayed and continuously updated on the visual display screen 3 along with the image of the balloons 61.
  • the control circuit 40 is operated for in turn operating the radio frequency generator 39 to generate the radio frequency signals, which are applied to the appropriate ones of the ablating electrodes 18.
  • the ablation device 70 is substantially similar to the ablation device 2, and similar components are identified by the same reference numerals. Indeed, the ablation device 70 is substantially similar to the ablation device 60.
  • the ablation device 70 comprises a plurality of independently inflatable balloons 71 , namely, five balloons 71. However, in this embodiment of the invention the centre balloon 71 a is axially longer than the other four balloons 71 b.
  • the balloons 71 b are of similar size to each other, and all five balloons 71 inflate to the same maximum diameter.
  • the centre balloon 71a is provided with a pair of stimulating electrodes 20, and four receiving electrodes 21 located between the stimulating electrodes 20.
  • the receiving electrodes 21 are equi-spaced apart axially from each other, and the spacing between the stimulating electrodes 20 and the adjacent receiving electrodes 21 is similar to the spacing between the receiving electrodes 21.
  • Each of the balloons 71 b is provided with two stimulating electrodes 20 and one receiving electrode 21 similar to those of the balloons 61 of the ablation device 60.
  • the advantage of providing the ablation device 70 with a centre balloon 71a which is longer than the axial length of the other balloons 71b is that it facilitates easier manoeuvring and more accurate placing the balloons 71 , and in particular, the centre balloon 71a axially centrally relative to the tissue 100 to be ablated. Additionally, the diameter of the centre balloon 71a can be determined at a number of axially spaced apart locations corresponding to the locations of the receiving electrodes 21.
  • ablation device 70 and its use and operation is similar to that of the ablation devices 2 and 60.
  • ablation systems 1 and 50 and the ablation devices 2, 60 and 70 have been described for use in ablating cancerous or precancerous tissue in the oesophagus of a human subject, it will be readily apparent to those skilled in the art that the systems 1 and 50 and the devices 2, 60 and 70 may be used for ablating any other tissue or matter from any other biological lumen or hollow organ.
  • the ablation system 1 and 50 and the ablation devices 2, 60 and 70 may be used for ablating tissue in, for example, the intestine, the colon, the urethra of a human or animal subject, in a lung of a human or animal subject, and indeed, may be used for ablating tissue in a vein, artery or the like, or indeed, in a cavity of the heart. It is also envisaged that the ablation devices and systems may be used for ablating any matter, tissue or other material which forms a structure or occlusion in a lumen, cavity or other hollow system, which may be biological or non- biological.
  • the ablation device 2 has been described as being provided with ten receiving electrodes, any number of receiving electrodes may be provided, and the number of receiving electrodes will be largely dependent on the length of the balloon and the required resolution of the image. Additionally, while two stimulating electrodes have been provided in the ablation device 2, in certain cases, a single stimulating electrode may be sufficient. Similar comments apply to the ablation devices 60 and 70.
  • the ablation device 60 has been described as comprising six independently inflatable balloons, the device 60 may be provided with any number of independently inflatable balloons, and it will also be appreciated that the independently inflatable balloons may be provided with more than one single receiving electrode.
  • the number of receiving electrodes will depend on the axial length of each independently inflatable balloon, as well as the required resolution of the image. Further, it is envisaged that in certain cases a single stimulating electrode may be sufficient in each of the independently inflatable balloons of the device 60.
  • independently inflatable balloons of the device 60 have each been described as carrying ablating electrodes, in certain cases it may not be necessary to provide ablating electrodes on all the independently inflatable balloons, but only on some of the independently inflatable balloons, and in particular, on the centrally located independently inflatable balloons, since the balloons will be manoeuvred into a position relative to the tissue or other matter to be ablated with the tissue or other matter to be ablated adjacent the centrally located independently inflatable balloons.
  • balloons of the devices 60 and 70 have been described as being independently inflatable, in certain cases, it is envisaged that it is not necessary that they be independently inflatable. Additionally in certain cases, some of the balloons may be independently inflatable relative to others of the balloons. While the ablation device 70 has been illustrated with a different number of ablating electrodes on the centre balloon as opposed to the number of ablating electrodes on the other balloons, in certain cases, it is envisaged that the number of ablating electrodes on the centre balloon may be the same or different to the number of ablating electrodes on the other balloons.
  • devices 2, 60 and 70 have been described as comprising the expandable element provided by a balloon or balloons, any other suitable expandable element may be provided.
  • any other suitable ablating means may be provided carried on the balloon or balloons.
  • the receiving electrodes have in general been described as being equi-spaced apart axially along the catheter, the receiving electrodes may be spaced apart at respective different spacings. Indeed, where the image representative of the profile of the balloon is required with a relatively high resolution, the electrodes will be spaced apart relatively closely, and where the image representative of the profile of the balloon is required with a lower resolution, the spacing of the receiving electrodes may be greater. It is envisaged in certain cases that it may be desirable to provide the image representative of the profile of the balloon adjacent the axial central portion of the balloon at a relatively high resolution, and the image representative of the profile of the balloon adjacent the respective axially opposite end portions with a lower resolution.
  • the receiving electrodes adjacent the central portion will be spaced apart more closely than the spacing between the receiving electrodes towards the respective axial opposite ends of the balloon. Indeed, in certain cases, it is envisaged that the spacing between the receiving electrodes may progressively increase from the central portion to the respective axial opposite ends. Needless to say, where the image representative of the profile of the balloon is required to be of a higher resolution at the axial opposite ends of the balloon than at the central portion thereof, the spacing between the receiving electrodes will be greater towards the central portion of the balloon than towards the respective axial opposite ends thereof.
  • image representative of the balloon or balloons displayed on the visual display screen has been described as being a three-dimensional image, it will readily be apparent to those skilled in the art that any suitable image representative of the balloon may be provided, for example, a longitudinal cross-sectional profile, or any other suitable image.
  • the image while it will be representative of the balloon, and may be representative of a three-dimensional image of the balloon or a longitudinal external profile of the balloon, the image may not be an exact image, since while the balloon when inflated in free air will inflate to a cylindrical configuration, nonetheless, the balloon is of a deformable material, and thus, will adopt the shape of the lumen or cavity within which it is located, which may not be entirely cylindrical, and thus, the image produced on the display screen, while it will be a reasonable representation of the balloon, will not be an exact representation of the balloon.
  • catheter has been described as being provided with a plurality of radial communicating openings for accommodating the first wires from the axial communicating bore to the stimulating and receiving electrodes
  • a single radial communicating opening may be provided for accommodating all the first wires to the stimulating and receiving electrodes, as well as accommodating the second wires to the ablation electrodes.
  • the single radial communicating opening would be provided in the form of an elongated slot which would extend along the catheter between the respective stimulating electrodes, or between the two axial outermost electrodes.
  • the axial communicating bore would not be sealed from the hollow interior region of the balloon, and thus, both the proximal and distal ends of the axial communicating bore would have to be sealably closed, and the seal at the proximal end of the axial communicating bore would have to seal against the first and second wires exiting therefrom.
  • any other electrically conductive inflating medium besides a saline solution may be provided for inflating the balloon or balloons.
  • the balloon and balloons have been described as being of cylindrical configuration when inflated, the balloons may be of any other shape, and may be of any other transverse cross-section besides circular.
  • the balloon or balloons when inflated may be of square, rectangular, triangular, hexagonal, polygonal or any other desired transverse cross-section, and in certain cases, it is envisaged that the transverse cross-section of the balloon or balloons may be matched to the cross-section of the lumen or cavity into which they are to be inserted.
  • first electrically conductive communicating means has been described as comprising a plurality of first wires coupling the stimulating and receiving electrodes to the current generator and the microprocessor, it is envisaged in certain cases that a single wire may be provided between the receiving electrodes and the corresponding analogue-to-digital converters, and the signals from the receiving electrodes would be multiplexed onto the single wire.
  • the multiplexer would typically be located either in the balloon or in the catheter, and would be coupled to the receiving electrodes by individual wires. It is also envisaged that the analogue-to- digital converters may be located in the balloon or in the catheter, and a single wire would be provided from a multiplexer also located within the balloon or the catheter to the microprocessor.
  • the multiplexer would be coupled to the analogue-to-digital converters by respective corresponding wires.
  • any other suitable and convenient system for coupling the electrodes, and in particular, the receiving electrodes to the microprocessor or the analogue-to-digital converters or the op- amps may be provided.

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Abstract

Système d'ablation (1) comprenant un dispositif d'ablation (2) servant à effectuer l'ablation de matière (100), tels qu'un tissu cancéreux ou une occlusion provoquée par, par exemple, la croissance d'un tissu cancéreux dans l'oesophage (101). Ce système est composé d'un cathéter (4) pourvu d'un ballonnet (7) contigu à l'extrémité distale (6) dudit cathéter. Quand il est gonflé, le ballonnet (7) présente une forme cylindrique et est situé sur le même axe que le cathéter (4). Des électrodes ruban d'ablation (18) sont placées sur une surface extérieure (23) du ballonnet (7) afin d'effectuer l'ablation du tissu (100). Une paire d'électrodes ruban de stimulation (20) est placée sur le cathéter (4) à l'intérieur d'une zone intérieure creuse (8) définie par les extrémités opposées contiguës (11, 12) du ballonnet (7). Une pluralité d'électrodes ruban réceptrices équidistantes (21) est placée sur le cathéter (4) entre les électrodes de stimulation (20). On applique un signal de courant de stimulation de valeur constante connue aux électrodes de stimulation (21) quand le ballonnet est rempli d'une solution saline et on lit les signaux de tension électrique apparaissant sur les électrodes réceptrices (21) afin de déterminer le diamètre du ballonnet (7) au niveau d'emplacements correspondant aux électrodes réceptrices (21), de façon à pouvoir afficher sur un écran visuel (3) une image tridimensionnelle représentant le ballonnet (7). Le praticien peut identifier immédiatement le profil longitudinal du ballonnet (7) qui, lorsque celui-ci est gonflé à l'intérieur de l'oesophage, correspond au profil longitudinal de l'oesophage contigu au ballonnet (7). Ceci permet au médecin ou au chirurgien de localiser sans difficultés le ballonnet (7), les électrodes d'ablation (18) étant alignées sur le tissu (100) dont il convient d'effectuer l'ablation.
PCT/IE2008/000068 2007-06-27 2008-06-27 Système d'ablation, dispositif et procédé servant à effectuer l'ablation de matière dans une lumière ou une cavité WO2009001326A1 (fr)

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