Esophageal probe with the temperature change speed detection system

Abstract

The present invention has for object a device (1) for detecting the temperature of the esophagus (E) in cardiac ablation treatments which device, unlike known devices, allows to more securely monitor the temperature of the esophageal lumen, thereby promptly detecting any possible criticality to which the patient (P) may be exposed due to excessively rapid temperature fluctuations.

Claims

1. A device for detecting the temperature of the esophagus in cardiac ablation treatments, comprising an esophageal probe insertable into the esophagus of a patient, and at least one sensor disposed on said probe and suitable to detect the temperature of a respective portion of said esophagus, said at least one sensor being configured to generate, in successive time instants, respective detection signals indicative of said temperature, wherein said device further comprises a control unit connectable in use to said probe for receiving said detection signals from said at least one sensor and programmed with at least one preset temperature limit value reachable from said respective portion of the esophagus, characterized in that said control unit is configured to calculate, for each of said instants and at least partially as a function of said detection signals, a variation speed of said temperature, and to determine, for each of said instants and as a function of said temperature variation speed of said respective portion of the esophagus, a residual time value required to achieve said at least one temperature limit value by said respective portion of the esophagus, said device being further configured to provide on output, for each of said instants, at least one information correlated to the residual time value required to achieve said temperature limit value by said respective portion of the esophagus, and at least one further information correlated to the value of said temperature variation speed of said respective portion of the esophagus.

2. A device according to claim 1, wherein said at least one further information comprises an acoustic and/or luminous signaling and said device comprises at least one acoustic and/or luminous signal giver suitable to generate said signaling, and wherein said control unit is configured to emit at least one activation signal suitable to activate said acoustic and/or luminous signal giver when said calculated residual time value is equal to or lower than a preset threshold value, said threshold value being able to be set and stored in the control unit by a user.

3. A device according to claim 1, wherein said at least one information comprises a viewing of said residual time value and said device comprises at least one viewer configured for viewing a numerical value of said residual time.

4. A device according to claim 1, wherein said control unit is configured to calculate said temperature variation speed for each of said instants by calculation of a first derivative or approximation thereof of the temperature values detected by said at least one sensor.

5. A device according to claim 1, comprising two or more temperature sensors disposed on said probe and adapted to detect the temperature of several respective portions of said esophagus, each of said sensors being configured to generate, in successive time instants, respective detection signals indicative of the temperature of the corresponding portion of the esophagus, wherein said control unit is adapted to receive the detection signals from each of said sensors, wherein said control unit is configured, for each of said sensors and for each of said instants, to calculate a temperature variation speed of the corresponding portion of the esophagus and to determine a corresponding residual time value required to reach said temperature limit value by the respective portion of the esophagus, said device being further configured to provide on output, for one or more of said sensors and for each of said instants, at least one respective information related to the residual time value required to achieve said temperature limit value by the respective portion of the esophagus.

6. A device according to claim 5, wherein said at least one information comprises a viewing of said residual time value and said device comprises at least one viewer configured for viewing the numerical value of said residual time, wherein said viewer is configured to view, among all the residual time values calculated for said sensors, only the numerical value of the residual time of lower entity.

7. A device according to claim 5, wherein, for each of said sensors, said control unit is configured for calculating said temperature variation speed of the corresponding portion of the esophagus, at least partially as a function of the detection signals coming from the respective sensor, and wherein, for each of said sensors said control unit is configured to calculate said residual time value required to achieve said temperature limit value by the respective portion of the esophagus as a function of the respective variation speed of the previously calculated temperature.

8. A device according to claim 5, wherein said probe comprises a catheter.

9. A device according to claim 1, wherein said at least one temperature limit value can be set and stored in the control unit by a user.

10. A device according to claim 1, wherein said probe is devoid of any ablators.

11. A device according to claim 1, wherein said at least one sensor is associated with at least a transducer for generating at least said detection signals.

Description

(1) The following detailed description refers to the appended drawings wherein:

(2) FIG. 1 shows a part of a particular embodiment of the present invention in a possible condition of use;

(3) FIG. 2 schematically illustrates how the present invention operates.

(4) In FIG. 1 it is shown a device 1 for measuring and monitoring the temperature of the esophagus E in the course of cardiac ablation treatments, according to a particular embodiment of the present invention.

(5) The device 1 comprises an esophageal probe, which in turn comprises advantageously, in the embodiment illustrated, an esophageal catheter 2 insertable into the esophagus E of a patient P.

(6) The attached figures refer to a specific condition of use during which an electro-catheter Ec is inserted in the heart H of a patient P. In the detailed description of herein, this electro-catheter Ec is not to be confused with the catheter 2 belonging to the device 1.

(7) In the condition of use depicted in FIGS. 1 and 2, the electro-catheter Ec serves to remove, by heating, the pathological tissue responsible for anomalies in the patient's P heart rhythm.

(8) The present invention however also applies in the case of cardiac ablation treatment occurring by cooling, also termed cryo-ablation treatment.

(9) The Ec electro-catheter operates preferably on the inner surfaces of the heart H left atrium of the patient P.

(10) In the specific embodiment herein illustrated, the device 1 comprises three temperature sensors 3a, 3b and 3c disposed on said catheter 2. The number of sensors may be different from that of the embodiment shown.

(11) The number of sensors of the illustrated embodiment is to be considered for purposes of example only.

(12) In the embodiment depicted, the catheter 2 is advantageously devoid of any ablators.

(13) Each of the sensors 3a, 3b and 3c is suitable to detect the temperature of a respective portion of said esophagus E. These portions of the esophagus E belong to the esophageal region which, in the illustrated use condition, is most involved in temperature increase resulting from Ec electro-catheter activities.

(14) In the embodiment shown, the sensors 3a, 3b and 3c are arranged along the catheter 2 in order to sense the temperature of respective different portions of the esophagus E. In addition, in the embodiment shown, the sensors 3a, 3b and 3c are distributed along a major extension direction of the catheter 2.

(15) The arrangement of the sensors 3a, 3b and 3c along the catheter 2 is further visible in FIG. 2.

(16) Each of these sensors 3a, 3b and 3c, is configured to generate, at successive instants, respective detection signals indicative of the temperature of the corresponding portion of the esophagus E. These detection signals are indicated in FIG. 2 by the arrows r.

(17) Preferably each of said sensors 3a, 3b and 3c is associated with at least a respective transducer, not shown, for generating at least said detection signals r. The assembly of at least one sensor and at least one transducer may then be defined as a temperature detector.

(18) Such detector may comprise for example at least one conductor or several conductors adapted to be subjected to a difference in potential indicative of the detected temperature.

(19) The device 1 further comprises a control unit C that is connectable in use to said catheter 2. The control unit C is adapted to receive, via non-illustrated connecting means, for example by way of one or more connectors, the detection signals r coming from each of the sensors 3a, 3b and 3c.

(20) The box C of FIG. 2 is a block, which schematically illustrates the control unit C. The same FIG. 2 is illustrative of the shape of the catheter 2, at least in relation to the positioning of the sensors 3a, 3b and 3c.

(21) The control unit C is programmed with at least one temperature limit value reachable by the esophagus E. This temperature limit value can be set and stored in the control unit C by a user.

(22) In the use condition shown in FIG. 1, this temperature limit value is a maximum value, in that the electro-catheter Ec is capable of carrying out a cardiac ablation treatment occurring by heating.

(23) In a further use condition, wherein the treatment may be a cryo-ablation treatment, i.e. an ablative treatment occurring by cooling, this temperature limit value might be a minimum value.

(24) For each of the sensors 3a, 3b and 3c, the control unit C is configured to calculate, within or in respect to each of said time instants, a temperature speed variation of the corresponding portion of the esophagus E. The respective portion of which the control unit C is calculating the temperature variation speed may therefore, in the specific case referred to by the appended figures, be a portion of the esophagus E associated to the sensor 3a, to the sensor 3b or to the sensor 3c.

(25) For each of the sensors 3a, 3b and 3c, the control unit C is advantageously configured to perform the calculation of the respective temperature variation speed, at least partially as a function of the detection signals r coming from the respective sensor 3a or 3b or 3c.

(26) For each sensor 3a or 3b or 3c, the control unit C is advantageously so configured as to be able to filter and/or eliminate the frequency components related to disorders in the temporal evolution of temperature of the corresponding portion of the esophagus E, for example by attributing to a certain instant, an average temperature calculated as the average among the values actually observed in several respective instants.

(27) In FIG. 2 the passage of detection signals r from the sensors 3a, 3b and 3c to the central unit C is shown schematically by the arrows r, which therefore indicate in general both these detection signals r and the passage thereof from the sensors 3a, 3b and 3c to the control unit C.

(28) For each of the sensors 3a, 3b and 3c, the control unit C is configured to determine, within or is respect to each of said time instants, a residual time value required to reach said temperature limit value by the respective portion of the esophagus E.

(29) For each of said sensors 3a, 3b and 3c, said central unit C is advantageously configured to perform calculation of said residual time value as a function of the respective temperature variation speed.

(30) The latter speed can advantageously be that previously calculated by the control unit C for the respective sensor 3a or 3b or 3c and for the same time instant.

(31) In other words, for each of the sensors 3a, 3b and 3c and for each of these instants, the control unit calculates an approximation of the temperature variation speed of the respective portion of the esophagus E and, based on said speed, the estimated residual time for reaching the temperature limit value by that respective portion.

(32) In the embodiment shown, for each time instant, the control unit C calculates three residual time values. Each of said three residual time values is then associated with a respective portion of the esophagus and to the respective sensor 3a or 3b or 3c.

(33) For each of said instants and for each of the sensors 3a, 3b and 3c, the control unit C is configured to calculate the temperature variation speed by calculating the first temporal derivative or approximation thereof of the temperature of the corresponding esophagus E portion.

(34) In particular, the calculation of the first temporal derivative approximation of the temperature of the corresponding esophagus E portion may be based on the ratio between the difference existing between at least two temperature values detected by the respective sensor 3a or 3b or 3c, and the temporal distance between the instants associated with said at least two values respectively.

(35) The device 1 is further configured to provide on output, for one or more of said sensors 3a, 3b and 3c and for each of said instants, at least one respective information. Such at least one respective information is related to the residual time value required to achieve said temperature limit value by the respective portion of the esophagus E.

(36) In the embodiment shown, said at least a respective information, for each of said sensors 3a, 3b and 3c, may comprise an acoustic and/or luminous signaling. This signaling is illustrated in FIG. 2 by an arrow denoted by Sa for the sensor 3a, by an arrow Sb for the sensor 3b and by an arrow Sc for the sensor 3c.

(37) To this end, the device 1 comprises, for one or more of said sensors 3a, 3b and 3c, at least one acoustic/luminous signal giver 4a or 4b or 4c. The signal giver 4a or 4b or 4c is suitable to generate a respective signaling Sa or Sb and Sc.

(38) For each of said sensors 3a, 3b and 3c, the control unit C is configured to emit at least one activation signal A suitable for activating at least one respective signal giver 4a or 4b or 4c. The control unit C is configured to emit said at least one activation signal in at least three circumstances: the temperature has reached the preset threshold value, the temperature variation speed has reached the preset threshold value, the residual time value required to achieve that temperature limit value by the respective portion of the esophagus E, is equal to or lower than a preset threshold value.

(39) These threshold values can be set and stored in the control unit C by a user.

(40) Such at least one activation signal A is represented in FIG. 2 by at least one arrow A which also indicates passage thereof from the control unit C to the respective signal giver 4a or 4b or 4c.

(41) In the embodiment shown, several signal givers 4a 4b and 4c are depicted, each of which is functionally associated with a respective sensor 3a or 3b or 3c. The control unit C, in the embodiment shown, is therefore capable of sending more activation signals A, each of which can activate a respective signal giver 4a or 4b or 4c on the basis of the calculated residual time value required to reach said temperature limit value by the respective portion of the esophagus E.

(42) Each of the signal givers 4a or 4b or 4c is preferably connected to the control unit C via connecting means (not shown), for example via one or more connectors. Each of these signal givers 4a or 4b or 4c may further be physically integrated in the control unit C, and/or disposed on the same control unit C, and/or fitted thereon.

(43) Said at least one information may further or alternatively comprise, for each of the sensors 3a, 3b and 3c, viewing said calculated residual time value required to reach said temperature limit value by the respective portion of the esophagus E. Such viewing is indicated in FIG. 2 by an arrow referred to with Va for the sensor 3a, by an arrow Vb for the sensor 3b and by an arrow Vc for the sensor 3c.

(44) To this end the device 1 comprises, for one or more of said sensors 3a, 3b and 3c, at least one viewer 5a, 5b or 5c. Each of the viewer 5a, 5b and 5c is suitable to generate a respective viewing Va or Vb or Vc.

(45) In the embodiment shown there are multiple viewers 5a, 5b and 5c, each of which suitable to then view the numerical value of said residual time value required to achieve said temperature limit value by the respective portion of the esophagus E, of which the respective sensor 3a or 3b or 3c, associated with the respective viewer 5a or 5b or 5c detects the temperature.

(46) According to a further possible embodiment there may be provided, by way of example, a single viewer that is suitable to view the lowest residual time value among all those calculated by the control unit C for the esophagus portions of which, the respective sensors 3a, 3b and 3c detect the temperature.

(47) For the sake of completeness, FIG. 2 further depicts additional arrows T, which are an example of the further signals T that can be emitted by the control unit C. Such additional T signals are used by the viewer 5a or 5b or 5c to view temperature, temperature variation speed and residual time value associated with the respective sensor 3a or 3b or 3c.

(48) Each of the viewers 5a or 5b or 5c is preferably connected to the control unit C via connecting means not shown, for example via one or more connectors. Each of those viewers 5a or 5b or 5c may also be physically integrated in the control unit C, and/or disposed on the same control unit C, and/or fitted thereon.

(49) For one or more of the sensors 3a, 3b and 3c, such at least one information may further or alternatively comprise viewing of the evolution in time of said temperature detected by the respective sensor 3a or 3b or 3c, or of said time residual value required to achieve said temperature limit value by the respective portion of the esophagus 3.

(50) This information may further or alternatively comprise the numerical value of the temperature detected by each sensor 3a or 3b or 3c.

(51) It should be appreciated that, in other possible embodiments, the number of viewers 5a, 5b and 5c and/or the number of signal givers 4a, 4b and 4c may differ from that shown. The number of viewers or signal givers may also differ from the number of sensors 3a, 3b and 3c.

(52) The invention attains the intended aim, and unlike the devices currently known, it makes available a device capable of controlling with a greater safety margin the temperature of the esophageal lumen in the course of cooling or heating cardiac ablation treatments.

(53) This device may also be easily set in order that the limit temperature and/or said safety margin can be varied as a function of any particular needs.