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WO2007010073A2 - Appareil et procede de protection thermique de l'oesophage - Google Patents

Appareil et procede de protection thermique de l'oesophage Download PDF

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Publication number
WO2007010073A2
WO2007010073A2 PCT/ES2006/000430 ES2006000430W WO2007010073A2 WO 2007010073 A2 WO2007010073 A2 WO 2007010073A2 ES 2006000430 W ES2006000430 W ES 2006000430W WO 2007010073 A2 WO2007010073 A2 WO 2007010073A2
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WO
WIPO (PCT)
Prior art keywords
esophagus
temperature
fluid
cooling
ablation
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Application number
PCT/ES2006/000430
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English (en)
Spanish (es)
Other versions
WO2007010073A3 (fr
Inventor
Enrique BERJANO ZANÓN
Fernando Hornero Sos
Original Assignee
Universidad Politecnica De Valencia
Fundación Comunidad Valenciana Hospital General Universitatio
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Application filed by Universidad Politecnica De Valencia, Fundación Comunidad Valenciana Hospital General Universitatio filed Critical Universidad Politecnica De Valencia
Publication of WO2007010073A2 publication Critical patent/WO2007010073A2/fr
Publication of WO2007010073A3 publication Critical patent/WO2007010073A3/fr

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Classifications

    • 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
    • A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
    • 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
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00084—Temperature
    • 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
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
    • 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
    • A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
    • A61B2090/0409—Specification of type of protection measures
    • A61B2090/0418—Compensation

Definitions

  • the invention is encompassed in the field of organ protection systems in relation to surgical or therapeutic interventions.
  • the esophagus is an organ of vital importance in the maintenance of life. At the retrocardial level, its walls are very close to the heart, and in particular to the free wall of the left atrium (K. Lemola, M. Sneider, B. Desjard ⁇ ns, I. Case, J. Han, E. Good, K Tamirisa, A. Tsemo, A. Chugh, Bogun F r F Jr Pelosi, E. Kazerooni, F Morady, H. Oral: "Computed tomographic analysis of the • anatomy of the left atrium and the esophagus: implications for left atrial catheter ahlat ⁇ on " f Circulation, vol. 110, pp. 3655-3660, 2004).
  • the present invention proposes a system that allows thermal protection of the esophagus during intraoperative ablation, and especially during percutaneous ablation.
  • WO-A- 99/05996 deals with an oral insertion probe that is housed in the esophagus at the height of the aorta, and which allows maintaining body temperature during a cardiac surgery operation. It is based on circulating a fluid through the probe to achieve temperatures between 37 and 41 0 C in the area of the esophagus.
  • WO-A-03/105736 deals with a catheter that allows topical cooling of body areas. However, since it is not designed for endocavitary structures, it cannot be inserted into the esophagus. Furthermore, while WO-A-03/105736 deals with a general topical cooling system for therapies, it makes no reference to the prevention of thermal damage caused by the proximity of ablated areas.
  • US-B-6261312 is about an inflatable catheter for heating or cooling selected organs. . However, the system. It is based on providing a change in the temperature in the blood that feeds that organ. It is therefore difficult 'application to the case of the portion of the esophagus near the heart wall.
  • US-B-6726708 is a system based on inflatable and cooled balloon to control the temperature of the colon or stomach. The same system can be used to monitor the temperature in the area of the esophagus, but there is no reference to the swelling of the cooling balloon in the area of the esophagus.
  • US-A-2004/210281 presents an apparatus based on probes and inflatable balloons internally cooled and located in the esophagus, allow to cool the cardiac tissue. Said apparatus is oriented to create a mild hypothermia (32-35 0 C) in said tissue and thus minimize metabolic expenditure after, for example, a myocardial infarction, or any case of hypoxia or ischemia in any other tissue.
  • the device is oriented to achieve hypothermia slowly (from decrements of 0.5 ° C / hour, until no more than 1 ° C / minute). Therefore, it would not be possible with this device to achieve a rapid evacuation of the heat generated in the wall of the esophagus during the no more than 120 seconds that an ablation lasts. . • Furthermore, said apparatus allows not only the cooling of the organ, adjacent to the cooled probe or balloon, but of other organs adjacent to it. Therefore, it would not be valid to thermally protect the esophagus during cardiac ablation, since during this procedure it is desired to thermally injure the cardiac wall.
  • the apparatus described in US-A-2004/210281 is more oriented to slowly lower the temperature not only of an organ, but of other adjacent tissues, while the problem of protecting the esophagus during ablation should be based on evacuating rapidly. the heat created in the vicinity of the chilled ball or probe.
  • Esophageal balloon cooling catheter is an inflatable balloon-based system that is positioned in the esophagus and internally cooled, allows thermal protection of the esophagus during atrial ablation, as well as monitoring e cardiac and esophageal image.
  • the document that has been accessed does not include any detailed description of the system that allows to evaluate the efficacy and safety of said invention - in order to protect thermally the esophagus during an ablation of a nearby organ.
  • a first aspect of the invention relates to an apparatus for thermal protection of the esophagus (or at least a part of the esophagus) of a patient, to avoid damage to the esophagus due to overheating in correspondence with an intervention of hyperthermal ablation in the vicinity of the esophagus.
  • the apparatus comprises a flexible element configured to be inserted by the patient's mouth or nose, said flexible element comprising at least a part intended to be in contact with the esophagus, the flexible element comprising at least one circulation circuit of a configured cooling fluid for the circulation of a cooling fluid through the part intended to be in contact with the esophagus, in order to cool the corresponding part of the esophagus to avoid hyperthermia injuries.
  • the flexible element has a portion configured to input and output device connected to a fluid pumping refrigerator, "so that said pumping device to pump fluid cooler cooler fluid through the circulation circuit.
  • the temperature of the esophagus (or the relevant part of the esophagus) can be maintained at a level that avoids hyperthermia damage during a hyperthermia ablation intervention in the area near the esophagus.
  • the part intended to be in contact with the esophagus is provided with means for measuring parameters related to temperature in an area of contact with the esophagus.
  • the temperature can be monitored during the operation and changing the temperature of the cooling fluid and / or the pumping rate based on the development of this' temperature.
  • the device can be equipped with an electronic system (which can be external to the patient) configured to interpret data provided by the measurement means, of parameters related to temperature, and to modify the operation of the device based on said data .
  • an electronic system which can be external to the patient
  • the electronic system may be configured to modify the temperature of the cooling fluid and / or a pumping rate of the cooling fluid, depending on said data provided by the means of measuring parameters related to the temperature.
  • the temperature-related parameter measuring means may comprise a plurality of electrodes for measuring the electrical impedance of the tissue adjacent to the electrodes (that is, in the wall of the esophagus), and / or a plurality of temperature sensors for the measurement of the temperature reached in a plurality of points of the esophagus.
  • the same electrodes may be configured to serve for recording electrograms associated with the attached cardiac tissue.
  • At least some of the electrodes and / or the temperature sensors may be distributed around the part intended to be in contact with the esophagus (ie, angularly distributed around the axis length of this part), to ensure that there is always at least one temperature sensor and / or electrode located close to the area corresponding to the atrial wall where the ablation occurs, regardless of the possible rotation of the flexible element that is introduced into the esophagus.
  • the flexible element may comprise a tubular probe, for example, of plastic.
  • the tubular probe can fundamentally protect that portion of the perimeter of the esophagus that is in intimate contact with the probe.
  • the circulation circuit may comprise two concentric or coaxial ducts that are in communication at a distal end of the probe, so that through one of said ducts the cooling fluid can flow to said distal end and then return through the other of said ducts, so that the cooling fluid, when flowing through an external duct of said two concentric or coaxial ducts, can cool a part of the esophagus with which the tubular probe is in contact.
  • the probe may have a diameter greater than or equal to 4 mm and less than or equal to 15 mm in the part intended to be in contact with the esophagus.
  • the apparatus may also include the ' pumping device, which may be a device configured to pump a precooled liquid fluid.
  • the flexible element can be a catheter and the part intended to be in contact with the esophagus can be an inflatable balloon that is part of said catheter, the circulation circuit being configured to make circulating the cooling fluid through said inflatable ball.
  • the balloon when swollen, can open the light of the esophagus, allowing the surface of the ball to come into intimate contact with the entire perimeter of the esophagus at the height of its position.
  • the inflatable balloon may have a circular cross section, for example.
  • the inflatable balloon may have a maximum diameter in a swollen state of greater than 10 mm and less than 20 mm, for example.
  • the ball may have a length greater than or equal to 5 cm and less than or equal to 15 cm, for example. In fact, the ball must be long enough to protect an extensive area of the esophagus. It should be borne in mind that thermal lesions created in the atrium during ablation for the suppression of atrial fibrillation follow in most cases a linear and extensive pattern. In this sense, it is interesting to have a thermal protection system that without repositioning the cooled balloon, allows almost all the necessary lesions in the atrium to be completed safely for the esophagus.
  • the apparatus may further comprise the pumping device, said pumping device being a pumping device for a precooled fluid. It can be a device configured to pump a precooled gas.
  • the apparatus according to any of the modalities described above may be configured for the circulation of a cooling fluid with a temperature greater than or equal to 10 0 C and less than or equal to 30 0 C.
  • a cooling fluid with a temperature greater than or equal to 10 0 C and less than or equal to 30 0 C.
  • the apparatus may be configured for the circulation of the cooling fluid at a speed sufficient to maintain the part of the esophagus with which the flexible element is in contact, at a temperature sufficiently low to prevent damage to the esophagus in relation to an ablation intervention. for hyperthermia- in the area. It involves evacuating excess temperature from the wall of the esophagus. Both the temperature of the fluid or gas, and the speed of the same can be programmed by the user from the same pumping system. The optimum values can be programmed from the results suggested by the mathematical modeling or by the clinical experience based on the ' records of thermal evolution obtained by means of temperature sensors located in the refrigerant system itself or in the ablation electrodes.
  • the flexible member may be provided with at least one mark the radiopaque to facilitate proper positioning of Ia the flexible element, in correspondence with the part of the esophagus to cool. In this way, the device can be placed in a guided manner with fluoroscopy image or similar.
  • the flexible element for example, the probe or catheter
  • the flexible element may be provided with distance marks (for example, a ruler in centimeters or inches) to aid in its placement or repositioning; These marks may be present at least in an area that will be placed in correspondence with the insertion point (nose or - mouth) when the flexible element is placed in the • patient, in a position suitable for use.
  • the electronic system may be configured to modify the operation of an ablation generator in response to data indicative of a temperature rise above • a predetermined threshold (which may correspond to an absolute temperature or a temperature rise rate), supplied by means of measuring parameters related to temperature. This allows these means to be used to influence and even stop the ablation process, if necessary.
  • a predetermined threshold which may correspond to an absolute temperature or a temperature rise rate
  • Another aspect of the invention relates to a method for preventing unwanted lesions in the esophagus of a patient during a hyperthermal ablation process of an organ close to the esophagus of a patient (for example, the atrial wall), which comprises the passage of , for at least a substantial part of the ablation process, cooling a selected part of the esophagus with a device according to what has been described above.
  • Another aspect of the invention relates to a method for preventing unwanted injury • in the esophagus of a patient during an ablation process hyperthermic organ near the esophagus of the patient, comprising the steps of:
  • radio-opaque markings for example, the balloon or probe may have two radio-opaque markings at its ends; in this case, a balloon with a length between 5 and 10 cm could be used to ensure with some margin the exact location
  • the balloon or probe can be placed by electrocardiographic guidance based on the unipolar recording of the signals associated with atrial depolarization; thanks to the difference in amplitude between the signal recorded by two electrodes at the ends of the balloon or probe, and the signal registered with electrodes in the center, the atrium can be located in its portion closest to the esophagus; in this case a 15 cm balloon could be used, to ensure with certain margin the exact location of the atrium); and / or intraoperative anatomical guidance (during cardiac surgery it is easy to palpate the retrocardial wall of the left atrium, as well as the esophagus; by surgical palpation the exact position of the balloon or probe can be known);
  • the cooling device i.e. the balloon or probe, - this can be done without internal circulation, with normothermic physiological soil - that is, with a temperature of approximately 36 0 C-, in order to assess the tolerance when inflated by the patient - degree of discomfort, retrosternal pain, etc.); 4) initiate a circulation of a fluid through the cooling device, said fluid having a temperature greater than 30 ° C (for example, between 35 ° C and 37
  • the size of the inflatable balloon must be selected, for example by one of the following criteria: a) the anatomical size of the organ to be ablated 0 (by some diagnostic imaging system, by example,. echocardiography, CT or cardiac magnetic resonance imaging); or b) the guidance method for esophageal implantation described above.
  • step 2) can optionally take note reading featuring an external rule (located on the body of the probe or catheter) exactly at the height of the insertion point (in mouth or nose) ' ".
  • step 4) it may be convenient to recheck the location of the balloon or probe by means of radiological, unipolar electrocardiographic, or surgical intraoperative control, and confirm that the balloon or probe has not moved. steps 5 and 6 it may be advisable to check the rheological operation of the balloon or probe, and record the electrical impedances before cooling by means of ins electrodes ertados in
  • the method may comprise the step of, in response to a detection of a temperature rise in the relevant area, increasing a flow rate of the fluid through the cooling device, and / or lowering the temperature • of said fluid, and / or interrupt the ablation process.
  • the esophagus can be returned to its basal temperature, for example, according to one of two ways: a) by stopping cooling fluid circulating, thus achieving a progressive and spontaneous recovery of temperature; or, b) recirculating fluid at normothermic temperature (approximately 36 0 C).
  • Figure 1 Schematic view of the catheter system and inflatable balloon positioned in the esophagus at the height of the left atrial wall.
  • Figure 2. General schematic view of the catheter and inflatable balloon system.
  • Figure 3. General schematic view of the system based on internally cooled plastic probe from circulating and precooled fluid.
  • Figure 4. Schematic view of the inflatable balloon with a possible electrode arrangement for recording electrograms and impedance measurements, and temperature sensors.
  • Figure 5. Schematic view of the inflatable balloon system positioned in the esophagus and its relationship with the other elements (coolant pumping system, ablation generator, electronic system for signal processing acquired by sensors and electrodes).
  • Figure 6. Scheme of the possible evolution of the electrical impedance recorded by the electrodes of the balloon before and during an ablation of an adjacent organ.
  • Figure 7. Schematic view of the external ruler located on the body of the catheter or catheter at the level of the insertion point (oral or nasal).
  • Figure 1 reflects a possible embodiment of the invention in which the apparatus for thermal protection of the esophagus includes a catheter . 1 with a balloon 2 inflates' inside the esophagus 3 and the height of the ablation electrode 4 creating thermal injury 5 in the atrial wall 6. Also, as shown schematically in Figure 2, the balloon 2 is swollen and a gas or refrigerated fluid circulates inside it from a pumping device 7 through two conductors 13 (illustrated schematically in Figure 5).
  • the balloon 2 can be of a high pressure type, of elongated spherical shape, with a fixed diameter • which prevents uncontrolled swelling and therefore damage to the wall of the esophagus.
  • the walls are thin enough to transfer heat well. from the walls of the esophagus to the inside of the ball.
  • the ball when the ball is inflated, the ball remains in intimate contact with the walls of the esophagus, partially forming the curves and irregularities of said walls and thus achieving a good degree of protection.
  • the ball must be constructed of an external material that allows at the same time flexibility, formability, and a high degree of heat transfer.
  • the ball can have electrical insulating characteristics, especially its outermost coating.
  • the internal cooling of the balloon can be done by gas (nitrogen, for example) or by circulating liquid (saline, for example) similar to that of preheated balloons by circulating fluid for endometrial ablation of the uterus (WO-A -00/00100), or the ball proposed in US-A-2004/210281 to create a slight hypothermia in the esophagus.
  • a plastic tube 11 instead of the balloon catheter is possible ' to use a plastic tube 11 which in turn is internally cooled by a circulating fluid.
  • the design of the probe with liquid Circulating can be based on two coaxial ducts joined at the distal end 12 similarly to that described in. Publication WO-A-99/05996.
  • the probe could be made of polyurethane or silicone, have a variable external diameter (4-15 mm) and a total length between 20 and 25 cm. In addition, it should have a large enough internal diameter to house two coaxial ducts inside (ie, with fluid communication between both ducts) exclusively at the distal end of the probe.
  • the coolant will circulate through said ducts, so that when flowing through the outer duct, it will serve to cool the inner wall of the esophagus.
  • This configuration only the area of the esophagus in contact with or very close to the probe will be well protected.
  • a difference to take into account when choosing between this configuration and the inflatable balloon catheter is that the action of inflating the balloon can reduce, in some cases, the distance between the wall of the esophagus and the wall of the earpiece, and can increase the possibility of thermal damage.
  • the proximal end of the probe could be connected to a pump that would allow liquid circulation.
  • Said pump 17 could be of the conventional peristaltic type attached to a liquid reservoir (thermostatic bath) or a more elaborate system as proposed in US-A-2003/060864.
  • radiopaque markings 8.18 (figures 1 and 3 ) which together with radioscopy equipment makes it possible to determine the position of the device and its spatial relationship with other recording or ablation electrodes (also radiopaque).
  • the cooling elements can have metal electrodes 19 for recording the atrial or ventricular electrograms of the heart.
  • the technique has been previously described (F. Prochaczek r G. Jerzy, MJ Stopczyk: "A method of esophageal electrogram recording for diagnostic atrial and ventricular pacing” Pacing and Clinical Electrphysiology, vol. 13, pp. 1136-1141, 1990).
  • Electrodes of center 19 will be arranged at the same height, but on all four sides of the ball (front, back, right and left). This is intended to always have a ventral electrode, in contact with the part of the atrial wall, and thus avoid that during the introduction of the balloon it could rotate in its longitudinal axis and be arranged in the dorsal part of the esophagus, away from the signal electrocardiographic atrium. This can be checked by observing the amplitude of the unipolar electrograms associated with each of these four electrodes.
  • unipolar electrograms are captured as the difference in electrical voltage between each of the four electrodes and a reference electrode located at a remote point (for example the one used for recording surface electrocardiogram). Bipolar electrograms could also be recorded (between two of these four electrodes).
  • the two electrodes of the ends of the balloon (proximal and distal) can also serve as reference electrodes for said unipolar registers.
  • These same electrodes 19 could also serve to monitor the unipolar or bipolar impedance of the adjacent tissue, that is, of the wall of the esophagus. The evolution of this impedance, which is closely related to the temperature of said tissue (WM Hartung, ME Burton, AG Deam, PF Walter, K.
  • FIG. 6 shows a possible evolution of the impedance (Nomenclature: T E (temperature in the wall of the esophagus), T PA (temperature in the atrial wall, or in any organ subject to ablation), Z (electrical impedance measured between two electrodes of the balloon, or between one of the electrodes and a distant reference electrode.)
  • T E temperature in the wall of the esophagus
  • T PA temperature in the atrial wall, or in any organ subject to ablation
  • Z electrical impedance measured between two electrodes of the balloon, or between one of the electrodes and a distant reference electrode.
  • phase B in figure 6 the temperature of the esophagus will experience a rise due to the thermal energy that arrives from the ablated zone by conduction. This thermal increase will be reflected in a change in the trend of the said impedance, which will begin to decrease. An excessive decrease in the value of this impedance will correspond to an excessive increase in the temperature of the tissue adjacent to the electrodes, that is, of the wall of the esophagus, and consequently reflect poor protection. On the contrary, a decrease in impedance that is not significant, or even absent, will suggest good thermal protection of the tissue adjacent to the electrode, that is, of the esophagus.
  • the cooling elements can have temperature sensors 20 on their surface in order to have a direct measure of quality of the cooling of the wall of the esophagus.
  • the position of these sensors could be, for example, right next to each electrode or, in any case, preferably with a certain radial distribution that allows a temperature sensor to always be in the area near the atrial wall to be monitored, regardless of rotation of the flexible element on its longitudinal axis.
  • Both the signals obtained from the electrodes 19, and the signals obtained from the temperature sensors 20, are physically supported by conductive cables 14 that are housed inside the catheter 1 or plastic probe 11.
  • the information obtained from both the impedance measurement signals, and from the temperature sensors themselves, can be processed by an electronic system 15 of simple implementation that estimates the thermal evolution of the wall of the esophagus, and therefore therefore, it can automatically modify the operation of the ablation generator 10 (for example, the power managed by said generator), or even directly cause its disconnection in order to avoid damage to the esophagus.
  • the ablation generator 10 for example, the power managed by said generator
  • Electrodes 19 for recording electrograms or for measuring impedance can be small in size.
  • the impedance measurement can be performed by injection of sinusoidal alternating current (20 kHz frequency, for example) and of low amplitude (1 mA, for example).
  • a pair of electrodes can be used through which the electric current is injected and received, and between which the voltage can be measured at the same time.
  • These two electrodes can be, for example, one of the electrodes 19 positioned in the inflatable balloon, and a reference electrode away from the area.
  • the electrodes can be adhered to the wall of the balloon as described in US-A-5255678.
  • the temperature sensors 20 may be small enough to be positioned on the surface of the balloon or probe itself, and be quick response.
  • K-type thermocouples bonded with epoxy resin to the inner wall of the balloon could be used (A. Rosen, P. Walinsky: “Microwave balloon angioplasty", in A. Rosen and H. Rosen “New Frontiers in Medical Device and Technology “, John Wiley & Sons, p. 33, 1995).
  • this method can be carried out, for example, according to the following steps:
  • the balloon will be placed in the esophageal lumen before starting the atrial ablation procedure. For this, it will be introduced through the nostril or through the patient's mouth, with the help of active swallowing of the patient and without the need for general anesthesia. Only a topical anesthetic with local spray can be applied
  • a selection of the size of the ball can be made using one of the following criteria: a) The anatomical size of the left atrium:
  • Echocardiography is the most available and simple, with four chambers measuring the superior inferior diameter of the atrium (distance between the mitral valve plane and the atrial roof) in its apical projection. This diameter offers the operator, with much approximation, the length of the atrium in contact with the esophagus. This distance will be the guideline when selecting the size of the ball, slightly larger to correct the inaccuracy of esophageal implantation. b) Using the guidance method for esophageal implantation (see options below).
  • the ball has two radio-opaque marks at its ends (see 8 in figure 4), which allow to position the ball accurately.
  • a ball with a length between 5 and 10 cm could be used to
  • the balloon can be placed by electrocardiographic guidance based on the unipolar recording of the signals associated with atrial depolarization. This procedure would be similar to the
  • the atrium can be located in its portion closest to the esophagus. In this case, a 15 cm ball, to ensure with certain margin the exact location of the atrium, c.
  • Intraoperative anatomical guidance During cardiac surgery it is easy to palpate the retrocardial wall of the left atrium, as well as the esophagus. With the anesthetized and intubated patient, it is easy to place the balloon, just as other probes such as intraoperative transesophageal echocardiography are placed. By surgical palpation you can know the exact position of the balloon before proceeding to its inflation. In this case, a 10 cm balloon could be used to ensure with certain margin the exact location of the atrium.
  • the esophagus can be returned to its basal temperature, in two ways: a) ceasing to circulate liquid, thus achieving a progressive and spontaneous recovery of temperature (this is probably the most natural and physiological form) ; or b) recirculating with liquid at normothermic temperature (36 0 C). This is probably a more damaging way because thermal gradients of very rapid evolution are created.
  • the ball will be removed by simple traction, after purging and complete extraction of its liquid or gas. It is important to ensure that the balloon is empty before removal in order to avoid injury due to tearing of the esophagus.
  • the invention is not limited to the specific embodiments that have been described but also covers, for example, the variants that can be made by the average person skilled in the art (for example, in terms of the choice of materials, dimensions , components, configuration, etc.), within what follows from the claims.

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  • Thermotherapy And Cooling Therapy Devices (AREA)

Abstract

L'invention porte sur un appareil utilisé pour refroidir une partie de l'oesophage, afin d'éviter des lésions provoquées par l'échauffement excessif de l'oesophage au cours d'une intervention d'ablation hyperthermique se situant à proximité de l'oesophage. L'appareil selon l'invention comprend un élément flexible (1, 11) conçu pour être introduit dans la bouche ou dans le nez du patient et une partie destinée à être placée en contact avec l'oesophage. L'élément flexible comprend un circuit de circulation d'un fluide réfrigérant conçu pour permettre la circulation d'un fluide réfrigérant dans la partie destinée à être placée en contact avec l'oesophage. L'élément flexible peut être relié à un dispositif de pompage (7, 17) de fluide réfrigérant et est équipé de moyens de détection de la température. L'invention porte également sur un procédé associé.
PCT/ES2006/000430 2005-07-22 2006-07-21 Appareil et procede de protection thermique de l'oesophage WO2007010073A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ESP200501892 2005-07-22
ES200501892A ES2267396B1 (es) 2005-07-22 2005-07-22 Aparato para la proteccion termica del esofago, y utilizacion del aparato para la proteccion termica del esofago.

Publications (2)

Publication Number Publication Date
WO2007010073A2 true WO2007010073A2 (fr) 2007-01-25
WO2007010073A3 WO2007010073A3 (fr) 2007-04-19

Family

ID=37669174

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ES2006/000430 WO2007010073A2 (fr) 2005-07-22 2006-07-21 Appareil et procede de protection thermique de l'oesophage

Country Status (2)

Country Link
ES (1) ES2267396B1 (fr)
WO (1) WO2007010073A2 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9743972B2 (en) 2014-07-18 2017-08-29 Medtronic Cryocath Lp Cardiac cryolipolysis for the treatment of cardiac arrhythmia
US10363162B2 (en) 2009-02-26 2019-07-30 Advanced Cooling Therapy, Inc. Devices and methods for controlling patient temperature
US10413444B2 (en) 2009-02-26 2019-09-17 Advanced Cooling Therapy, Inc. Treatment of ischemia-reperfusion injury by controlling patient temperature
US12115027B2 (en) 2018-04-04 2024-10-15 Advanced Cooling Therapy, Inc. Esophageal heat transfer devices and methods for cardiac tissue ablation

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* Cited by examiner, † Cited by third party
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US12226609B2 (en) * 2020-12-16 2025-02-18 Medtronic, Inc. Method to detect inadvertent delivery of drug to a subcutaneous pocket

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991005528A1 (fr) * 1989-10-19 1991-05-02 Granulab B.V. Dispositif servant a refroidir ou a rechauffer une personne
WO1999005996A1 (fr) * 1997-07-31 1999-02-11 Vasu M Andre Procede et appareil permettant de maintenir la temperature corporelle lors d'une intervention chirurgicale
US6290717B1 (en) * 1999-03-31 2001-09-18 Alsius Corporation Temperature probe and interconnect cable for hypothermia catheter temperature feedback
US6726708B2 (en) * 2000-06-14 2004-04-27 Innercool Therapies, Inc. Therapeutic heating and cooling via temperature management of a colon-inserted balloon
JP4474590B2 (ja) * 2002-06-17 2010-06-09 厚夫 森 局所冷却カテーテルおよびそれを用いた局所冷却デバイス
US7758623B2 (en) * 2003-03-17 2010-07-20 The Board Of Trustees Of The Leland Stanford Junior University Transesophageal heat exchange catheter for cooling of the heart

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10363162B2 (en) 2009-02-26 2019-07-30 Advanced Cooling Therapy, Inc. Devices and methods for controlling patient temperature
US10413444B2 (en) 2009-02-26 2019-09-17 Advanced Cooling Therapy, Inc. Treatment of ischemia-reperfusion injury by controlling patient temperature
US10716703B2 (en) 2009-02-26 2020-07-21 Advanced Cooling Therapy, Inc. Devices and methods for controlling patient temperature
US11633299B2 (en) 2009-02-26 2023-04-25 Advanced Cooling Therapy, Inc. Methods for protecting esophageal tissue from thermal injury
US12268631B2 (en) 2009-02-26 2025-04-08 Advanced Cooling Therapy, Inc. Devices and methods for protecting esophageal tissue from thermal injury
US9743972B2 (en) 2014-07-18 2017-08-29 Medtronic Cryocath Lp Cardiac cryolipolysis for the treatment of cardiac arrhythmia
US12115027B2 (en) 2018-04-04 2024-10-15 Advanced Cooling Therapy, Inc. Esophageal heat transfer devices and methods for cardiac tissue ablation

Also Published As

Publication number Publication date
WO2007010073A3 (fr) 2007-04-19
ES2267396B1 (es) 2008-02-16
ES2267396A1 (es) 2007-03-01

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