DEVICE FOR DETERMINING A PIECE OF INFORMATION RELATING TO A CARDIAC DECOMPENSATION STATE

Abstract

Disclosed is a device for determining a piece of information relating to a cardiac decompensation state of a user, the information being obtained by analysis of a cardiac parameter, characterized in that it includes a measuring device designed to determine a signal value by means of at least one accelerometer signal curve of the user, the signal value being intended to be compared with an additional signal value originating from a measurement by a cardiac monitor, the measuring device comprising, for this purpose, at least one accelerometer designed to determine said accelerometer signal curve, the measuring device being designed to be housed in an implant inside the user.

Claims

1. Device for determining a piece of information relating to a cardiac decompensation state of a user, said information being obtained by analysis of a cardiac parameter, characterized in that it includes at least one measuring device designed to determine a signal value by means of at least one accelerometer signal curve of the user, said signal value being intended to be compared with an additional signal value originating from a measurement by a cardiac monitor, the measuring device comprising, for this purpose, at least one accelerometer designed to determine said accelerometer signal curve of the user, the measuring device being designed to be housed in an implant inside the user.

2. Determination device according to claim 1, comprising a measuring means which is designed for measuring the additional signal value, said measuring means comprising at least the cardiac monitor, the determination device further comprising a calculation device designed for determining a value of the cardiac parameter depending on the time between the appearances of the signal and of the additional signal, the calculation device being designed to compare the cardiac parameter to a threshold value, exceeding which reveals a cardiac decompensation.

3. Determination device according to claim 1, wherein the measuring device is designed to assume a position in the implant such that the accelerometer is capable of measuring at least an acceleration according to one axis from the dorsoventral axis, a lateral axis, and a rostro-caudal axis.

4. Determination device according to claim 1, wherein the measuring device is designed to be housed in an intragastric implant inside the user.

5. Determination device according to claim 2, wherein the cardiac monitor is designed to be housed in the implant.

6. Determination device according to claim 2, wherein the calculation device is designed to be housed in the implant.

7. Determination device according to claim 2, wherein the measuring device comprises a communication member designed for transferring at least one signal to the calculation device.

8. Determination device according to claim 7, wherein the implant comprises an energy storage device which is capable of supplying at least the measuring device.

9. Method for determining a piece of information relating to a cardiac decompensation state of a user, the determination method implementing the determination device according to claim 1, during which a step of measuring signals makes it possible to obtain at least the signal value and the additional signal value, the signal value being obtained by the measuring device comprising at least the accelerometer, and the additional signal value being obtained by the measuring means comprising at least the cardiac monitor.

10. Determination method according to claim 9, implementing at least the calculation device, during which the step of measuring signals is followed by a step of calculating a cardiac parameter which makes it possible to obtain the information on the cardiac decompensation state, said calculation step taking into account a time lag of the appearance of the signals measured in the step of measuring signals.

11. Determination method according to claim 9, comprising a step of calibration of the measuring device, the calibration step preceding the step of measuring signals.

12. Determination method according to, claim 10 during which the calculation device compares, during the calculation step, the cardiac parameter with a threshold value determined during the calibration step.

Description

[0040] During the calculation step, the cardiac parameter is both calculated and compared with the threshold value determined during the calibration step. The cardiac parameter/threshold value comparison makes it possible to finely determine the cardiac decompensation state of the user.

[0041] FIG. 1 is a general schematic view of a determination device according to the invention,

[0042] FIG. 2 is a general schematic view of a determination device according to the invention in another embodiment,

[0043] FIG. 3 illustrates a method for determining a piece of information relating to a cardiac decompensation state of a user, the determination method implementing the determination device according to the invention,

[0044] FIG. 4 is a flow diagram illustrating the determination method of FIG. 3.

[0045] It should firstly be noted that the figures disclose the invention in a detailed manner for implementing the invention, it of course being possible for said figures to serve to better define the invention, if applicable.

[0046] In the remainder of the description, the designations “internal/inside” and “external/outside” refer to the determination device according to the invention, and more particularly to an implant that forms part of said determination device. Any element integrated in an implant of the determination device is described as internal/inside or internalized, and any element located outside of the implant is described as external/outside or externalized.

[0047] Referring first to FIG. 1, a device 1 for determining a piece of information relating to a cardiac decompensation state of a user 2 is visible. The piece of information relating to a cardiac decompensation state is obtained by analyzing a cardiac parameter shown in FIG. 3.

[0048] The determination device 1 comprises at least one measuring device 3, a measuring means 4, and a calculation device 5. In the case in point, part of the determination device 1, comprising the measuring device 3, is internalized, and another part of the determination device 1, comprising the measuring means 4 and the calculation device 5, is externalized.

[0049] The measuring device 3 comprises at least one accelerometer 30 which is designed for determining an accelerometer signal curve of the user 2, shown in FIG. 3. The measuring device 3 is designed for determining a signal value, also shown in FIG. 3.

[0050] The measuring device 3 including the accelerometer 30 is housed in an implant 6 inside the user 2. The implant 6 corresponds to a hollow, biocompatible, and sealed compartment. The implant 6 is dimensioned so as to be implanted by means of an endoscopic device. The view of the implant 6 in FIG. 1 is schematic, and the implant 6 may be of any shape and dimension which is compatible with the implantation thereof, the function thereof, and the operation of the determination device 1. It will also be understood that the method of implantation of the implant is not considered here and can be implemented by any means.

[0051] The implant 6 is an intragastric implant which is positioned, in the embodiment of FIG. 1, in the region of the fundus 20 of the stomach 21 of the user 2, close to the heart 26 of the user 2. The implant 6 is for example fixed to the surface of a gastric mucous membrane or within the gastric mucous membrane, in the region of the fundus 20 of the stomach 21, or in the region of any tissue of the gastrointestinal tract 25.

[0052] The implant 6 comprises an energy storage device 60 which is capable of supplying at least the measuring device 3. The energy storage device 60 is miniaturized and isolated from the tissues of the user 2, such as in this case by being inside the implant 6. The energy storage device 60 is designed to have a service life of several years, so as to be able to supply the measuring device 3 as needed.

[0053] The measuring device 3 is designed to assume a position in the implant 6 such that the accelerometer 30 is capable of measuring at least an acceleration according to one axis from the dorsoventral axis 22, a lateral axis 23, and a rostro-caudal axis 24, as shown in FIG. 1.

[0054] The measuring means 4 is designed for measuring an additional signal value shown in FIG. 3, and comprises, for this purpose, at least one cardiac monitor 40. The cardiac monitor 40, which is externalized in this embodiment shown in FIG. 1, is equipped with a display screen 41 which makes it possible to display a trace of an electrocardiogram, as shown in FIG. 3.

[0055] The cardiac monitor 40 is connected, by wired sensors 42 of the measuring means 4, to a set of in this case three electrodes 43 which are each connected individually to the cardiac monitor 40 and fixed to the user 2. This representation of the measuring means 4 is not limiting, in particular with respect to the number of electrodes 43 used, it being possible for the measuring means 4 to assume any form as long as it makes it possible to measure the additional signal value.

[0056] The calculation device 5 is designed for determining a value of the cardiac parameter from the signal value and the additional signal value. The calculation device 5 can also be designed for comparing the cardiac parameter to a threshold value, exceeding which reveals a cardiac decompensation.

[0057] In the embodiment of FIG. 1, the calculation device 5 is external. It is on the one hand electrically connected, by cabling 50, to the cardiac monitor 40, so as to receive the additional signal value. It is on the other hand wirelessly connected to the measuring device 3. In order to achieve this, the measuring device 3 comprises a communication member 31 designed for transferring at least one signal to the calculation device 5. in this case the signal value. The measuring device 3 in particular comprises a transmitter 32 of waves 33, the transmitter 32 being inside the implant 6 and being connected to the measuring device 3. The calculation device 5 comprises a receiver 51 which is capable of receiving the waves 33 transmitted by the transmitter 32 of the communication member 31.

[0058] In the following, the various calculations carried out by the calculation device 5 in order to determine, according to the invention, a reliable piece of information relating to a possible cardiac decompensation state of the user, will be described, in particular with reference to FIGS. 3 and 4.

[0059] FIG. 2 shows another embodiment of the invention, the measuring means 4 being internal. In other words, the implant integrates both the accelerometer which forms the measuring device 3 for obtaining the signal value, and the cardiac monitor which forms the measuring means 4 for obtaining the additional signal value. In the embodiment shown, the determination device 1 is compacted in part, the measuring device 3 and the measuring means 4 being embedded in the implant 6, only the calculation device 5 being externalized in this case. The description of FIG. 1 applies, mutatis mutandis, to FIG. 2, and reference can be made thereto in order to understand and implement the invention.

[0060] In the embodiment of FIG. 2, the cardiac monitor 40 is designed to be housed in the implant 6. It is, just like the measuring device 3, supplied by the energy storage device 60. The communication member 31 is shared between the measuring device 3 and the measuring means 4, such that it transfers both the signals originating from the accelerometer 30, and the signals originating from the cardiac monitor 40. For example, the measuring device 3 and the measuring means 4 each comprise a transmitter 32 of the communication member 31 which transmits, via waves 33, the signal value and the additional signal value towards one or more receivers of the calculation device 5.

[0061] The fact that there is no calculation module integrated in the implant implies that all of the accelerometer signal and all of the signal of the electrical activity of the heart are transmitted to the calculation module remote from the implant. From these two transmitted signals, the calculation module performs a search of the opening point of the aortic valve, on the accelerometer signal, and of the maximum of the peak R, on the electrocardiogram, in order to find a temporal value of these two events and to subsequently perform the calculation of the time difference between said two signals defined on the same time base.

[0062] It will be understood that the interest of a doubly integrated device of this kind, i.e. having the accelerometer and the cardiac monitor housed in the implant, is that of facilitating the synchronization of the measurements and the sharing of the same time base for performing the two measurements simultaneously.

[0063] In this context, it is possible to provide for the calculation device to be integrated at least in part, or entirely, into the implant 6. In particular, it can be provided for part of the calculation to be performed in the implant, i.e. the measurement and the detection of the appearance of two time signals, and for it to be only the values of these time signals which are transmitted to an external database.

[0064] FIG. 3 shows different cardiac data, measured and determined by the determination device 1.

[0065] The signal value 34 corresponds to a time value that is determined by means of at least the accelerometer signal curve 35 of the user 2 obtained by the accelerometer 30. The accelerometer signal curve 35 comprises positive peaks and negative peaks, including a maximum opening of the aortic valve of the user 2. When said maximum opening of the aortic valve is identified, it is defined as corresponding to the signal value 34 on the accelerometer signal curve 35. The calculation device 5 derives therefrom a time marker 36, for example at a time t1 on a given time base.

[0066] The additional signal value 44 also corresponds to a time value that is determined by means of at least the electrocardiogram 45 of the user 2 obtained by the cardiac monitor 40. The electrocardiogram 45 comprises positive waves and negative waves, which can include a wave P 450, a wave Q 451, the wave R 452, a wave S 453, a wave T 454, a wave U 455. When the maximum of the wave R 452 is identified, it is defined as corresponding to the additional signal value 44 on the electrocardiogram 45. The calculation device 5 derives therefrom a temporal marker 46, for example at a time t0 on the time base common to that used for determining the first time marker 36.

[0067] The appearance of the signal 34 is intended to be compared chronologically to the appearance of the additional signal 44. In other words, the calculation device as described above is designed to calculate a time duration between the value of the time marker 36 and the value of the temporal marker 46. The value of the pre-ejection period, i.e. of the cardiac parameter 27, corresponds to that time period between the time marker 36 and the temporal marker 46. The calculation device 5 thus applies a formula according to which: [PEP=t1−t0]. It will be understood that, according to the invention, this determination is made easy by the synchronous measurement of the two signals, i.e. the user of the same time base for performing these two measurements.

[0068] FIG. 4 shows a flowchart which is representative of a method 7 for determining a piece of information relating to a cardiac decompensation state of a user 2, the determination method 7 implementing the determination device 1 as described above in FIG. 1. The determination method 7 comprises at least one step of measuring 70 signals, and a calculation step 71. Advantageously, the determination method 7 comprises at least one calibration step 72. Each step is represented by a rectangle in FIG. 4, the succession of steps being in accordance with a chronology indicated by the arrows 100.

[0069] The calibration step 72 makes it possible to calibrate at least the measuring device 3. It will be understood that the calibration step is theoretically performed once, before the device is operational for taking successive measurements, the aim of the calibration step being to fix a basal state, said state being kept for each of the measuring steps which will follow. Before embarking on the different measuring steps, a plurality of steps of calibration 72 of the measuring device 3 may be envisaged, for example during the implementation of the measuring device 3 post-implantation, or at a distance from the placement of the implant 6.

[0070] The calibration step 72 makes it possible to determine a threshold value 73 which is representative both of the baseline cardiac activity of the user 2, and of the positioning of the accelerometer 30. More particularly, the calibration step 72 consists in a multiplication of measurements of the cardiac parameter and the calculation of an average value of these measurements in order to derive therefrom the reference signal value 37. Proceeding from the reference signal value 37, a threshold value 73 corresponding to a percentage of the reference signal value 37 is determined, and said threshold value 73 is intended to be compared with the cardiac parameters 27 obtained during the measuring steps following the calibration step 72.

[0071] During the step of measuring signals 70, at least the signal value 34 and the additional signal value 44 are obtained. During a first measurement sub-step 700 included in the measuring step 70, the measuring device 3, and more particularly the accelerometer 30, is implemented in order to obtain the signal value 34. During a second measurement sub-step 701 included in the measuring step 70, the measuring means 4, and more particularly the cardiac monitor 40, is implemented in order to obtain the additional signal value 44. In the embodiment shown, the first measurement sub-step 700 and the second measurement sub-step 701 take place concomitantly, such that the values obtained can be compared on the same time referential so as to be able to calculate the cardiac parameter 27 during the calculation step 71. It will be understood that, without departing from the scope of the invention, said two sub-steps can be carried out in a staggered manner, in particular if the measurement of one of the signals may impair the measurement of the other signal.

[0072] The step of measuring 70 signals is followed by the step of calculating 71 the cardiac parameter 27, the calculation step 71 being implemented by the calculation device 5. The calculation step 71 may be performed periodically or regularly, or following each step of measuring 70 signals, and/or upon request by the user 2 or the medical staff.

[0073] The calculation step 71 makes it possible to identify the time marker 36 and the temporal marker 46 and to deduce therefrom the cardiac parameter 27. During a first calculation sub-step 710, the time marker 36 is identified. During a second calculation sub-step 711, the temporal marker 46 is identified.

[0074] During a third calculation sub-step 712 taking place after the first calculation sub-step 710 and the second calculation sub-step 711, the cardiac parameter 27 is deduced by the calculation device 5.

[0075] During a fourth calculation sub-step 713 of the calculation step 71, the calculation device 5 compares the cardiac parameter 27 with the threshold value 73 determined during the calibration step 72, or with a threshold value implemented in a theoretical manner in the calculation device.

[0076] At the end of the calculation step 71, a piece of information 74 on the cardiac decompensation state of the user 2 is obtained, during an information step 75. If the cardiac parameter 27 detected corresponds to a value above the threshold value, the user 2 is for example in an early state of cardiac decompensation and can be warned of this.

[0077] It will be understood, upon reading the above, that the present invention proposes a determination device which is designed to warn of an early state of cardiac decompensation. Said determination device, intended in particular to be implanted, at least in part, in the user, comprises at least one accelerometer which participates in determining a pre-ejection period, allowing for reliable detection of the signal value to be compared with an additional signal, the integration of said accelerometer in an implant allowing for said reliable measurement. The information obtained by a determination device of this kind is intended to be reliable and allows for frequent use, so as to ensure simple and recurrent monitoring of a user at risk of cardiac complications.

[0078] However, the invention is not limited to the means and configurations described and illustrated here, and it also extends to any equivalent means or configuration, and to any operational technical combination of such means. In particular, the form of the determination device may be modified without adversely affecting the invention, insofar as the determination device ultimately fulfils the same functions as those described in this document.