Detection and alert system for patients at high cardiac risk

Abstract

The present invention relates to a detection and alert system for a garment (G) and an application module (APP) comprising means for triggering a point-by-point ECG recording. The application module (APP) is configured to store the patient's personal and medical data, as well as at least one previous reference ECG recording, and to transmit to a remote interface module (MD) an alert message encapsulating the stored personal and medical data, the stored reference ECG recording, and the point-by-point ECG recording. Figure for the abstract: Figure 1

Description

Title of the invention: Detection and alert system for patients at high cardiac risk. General technical field and prior art.

[0001] The present invention relates to a detection and alert system for patients at high cardiac risk.

[0002] It is known that the earlier a patient experiencing symptoms of a myocardial infarction receives treatment, the less serious the post-infarction sequelae are likely to be. Furthermore, the faster the treatment, the lower the risk of sudden death.

[0003] Today, when a patient calls an emergency medical center (in France, the 15 emergency number) for what they believe to be a cardiac symptom (chest pain, for example), a team (SAMU, firefighters) is automatically dispatched to the scene. It is only once the patient is present that a doctor can begin to make a diagnosis after performing an ECG. Despite the diligence of the responding emergency teams, a significant amount of time often elapses before this initial step, even though these first few minutes can be crucial for the patient.

[0004] In a number of cases, moreover, it is found that the chest pain was misinterpreted by the patient and that the intervention teams were mobilized inappropriately.

[0005] Many portable devices for remotely acquiring electrocardiogram signals from a patient are already known. In particular, clothing (vests or similar items) with ECG sensors integrated into the fabric and connected to a mobile application on the patient's phone is already known.

[0006] These devices do not solve the problems mentioned above: indeed, clothing incorporating ECG sensors is usually used like Holter monitors to make continuous recordings over several days. These recordings are transmitted by the application to a remote data collection platform and used to diagnose heart rhythm disorders over a monitoring period.

[0007] Defibrillator vests incorporating defibrillation electrodes and a charging battery are also already known. This type of vest delivers electric shocks to a patient's heart and is worn continuously by the patient to protect them from potential risks of "Sudden Cardiac Death". General presentation of the invention

[0008] One object of the invention is to provide a solution to shorten the time required for diagnosis and intervention in cases of symptoms of acute coronary syndrome for patients at high cardiac risk.

[0009] Another objective of the invention is to provide a solution to limit the cases where intervention teams are sent to the patient when it is not necessary.

[0010] Another objective of the invention is to offer a solution enabling the medical staff to direct the patient without loss of time to the correct level of care and, for example, to immediately trigger the booking of a coronary angiography room, without waiting for the ECG currently performed after the arrival of the medical team.

[0011] Thus, according to one aspect, the invention proposes a detection and alert system for patients at high cardiac risk comprising: - a garment with ECG sensors, said garment comprising a processing and communication unit adapted to communicate with a personal terminal of the patient - an application module adapted to be stored and executed by a processor on such a patient's personal terminal, - a remote interface module,

[0012] characterized in that the garment and / or the application module include means for triggering a one-time ECG recording and transmitting it to the application module when the patient feels the need,

[0013] the application module being configured to allow the storage of the patient's personal and medical data, as well as at least one previous reference ECG recording (for comparison with the ECG during chest pain),

[0014] said application module also being configured to transmit to a remote interface module an encapsulating alert message - personal and medical data thus stored, - the reference ECG recording is also stored, and - the spot ECG recording (performed during chest pain).

[0015] Advantageously, the garment also incorporates defibrillator pads.

[0016] Also, according to a preferred mode, the system includes means for implementing on the acquired point recording a pre-analysis processing which allows the ECG signals to be categorized according to their degree of severity.

[0017] The garment may be a vest which includes means for its application against a rib cage, a major part of the vest being able to be made of a fabric with elastic fibers.

[0018] These means may include adjustable length straps and / or self-gripping fasteners.

[0019] The system may further include means for installing a physical marker on the garment, in order to allow the patient to position it correctly.

[0020] The invention also relates to an application module downloadable onto a personal terminal, comprising instructions which, when executed by said personal terminal, allow the transmission to a remote interface module of an encapsulating alert message - personal data and stored medical data, - a reference ECG recording also stored, and - a one-time ECG recording performed by the garment of a system of the type mentioned above. Brief description of the drawings

[0021] Other features and advantages of the invention will become apparent from the following description, which is purely illustrative and not limiting, and should be read in conjunction with the accompanying figures in which: - [Fig.1] is a schematic representation illustrating a system conforming to an embodiment of the invention; - Figure [Fig. 2] illustrates the arrangement of the ECG sensors and defibrillator plates of a vest according to one possible embodiment of the invention, - Figures [Fig. 3a] and [Fig. 3b] illustrate a vest conforming to one possible embodiment of the invention, - Figures [Fig. 4a] and [Fig. 4b] illustrate a vest conforming to another possible embodiment, - Figures [Fig. 5a] and [Fig. 5b] illustrate two examples of menu pages from the application module of a system conforming to a possible embodiment of the invention, - Figure 6 illustrates the successive steps implemented by the application module of a system conforming to a possible embodiment of the invention, - Figures [Fig. 7a] and [Fig. 7b] illustrate two interface pages of the module, - Fig. 8 illustrates the structure of the message transmitted by the application module to the remote interface module.

[0022] Description of one or more implementation and realization methods

[0023] The system illustrated in [Fig. 1] comprises:

[0024] - a G-sensor vest with ECG sensors intended to be worn by a patient if he or she feels the onset of symptom,

[0025] - an application module APP stored and executed by a terminal processor patient's TP staff, and

[0026] - a remote interface module MD, which is for example installed in a center medical emergency.

[0027] An example of a configuration for the G vest is illustrated more particularly in [Fig.2],

[0028] The ECG sensors it comprises are electrodes AND PLATES integrated into the fabric of said vest G (electrodes referenced from 1 to 10). Vest G also includes three defibrillator plates ED. It also incorporates a power supply battery B, a UTC processing and communication unit, and electrical cables (not shown in the figure) to connect the various sensors 1 to 10, as well as the ED plates, to said battery B and to the UTC processing and communication unit.

[0029] A cable (also not shown) allows the integrated battery to be recharged on a charger suitable for being plugged into the mains.

[0030] The ECG sensors are typically ten in number and allow for 12-lead acquisition. They are arranged on the vest G so as to correspond to the areas of the patient where 12D ECG sensors are conventionally placed. In [Fig. 2], the ECG sensors and the ED plates are arranged on the part of the vest that corresponds to the patient's rib cage.

[0031] This configuration is also illustrated in Figures 3a and 3b. The vest G shown is a crossover vest. In this case, it is equipped with adjustable-length straps S and hook-and-loop fasteners F. The straps S have male and female clip-on ends. Together with the hook-and-loop fasteners F, they ensure that the vest is closed in a way that positions the precordial ECG sensors 1 to 6 against the chest and the other four peripheral ECG sensors against the patient's back when the patient puts on the vest G. The fabric of the vest G also contributes to this positioning. A major part of the vest (more than 50% of its surface area at rest) is made of an elastic fiber fabric. Typically, the back is made of rigid fibers, while the front of the vest is made of elastic fibers.

[0032] Other configurations are of course possible. In particular, some of the ECG sensors and at least one of the ED defibrillation pads can be positioned on the back of the vest G. This is illustrated in Figures 4a and 4b, which show a vest with four ECG electrodes (sensors 7 to 10) positioned on the back of the vest G, with three ED defibrillator pads. In these figures, the paths of the CE electrical cables integrated into the fabric of the vest G are also shown.

[0033] The patient's personal terminal TP is, for example, his mobile phone ("smartphone") on which the patient's APP application module is downloaded ([Fig.5a]). This application module APP is typically available in a version for iPhone® (registered trademark) and in a version for Android® (registered trademark).

[0034] The APP application module typically includes a menu with several pages. When the patient downloads the APP module, a home menu ([Fig.5a]) allows the patient to store personal data in their APP application (name, surname, date of birth, address, telephone number, social security number, referring cardiologist, trusted person, etc.).

[0035] The APP application module also stores the patient's medical data (medical history, current medical treatment, report of a previous coronary angiography or cardiovascular surgery, last prescription). It also allows the ECG signals previously acquired by the patient with the same G-vest (in particular, the reference electrocardiogram) to be stored on the TP personal terminal.

[0036] Typically, medical data is downloaded by medical personnel during a session to initialize and adjust the G-vest. Reference ECG signals can be acquired from the patient wearing the G-vest during this same session. The various medical data can also be updated by medical personnel during subsequent cardiology consultations.

[0037] The initialization step is for example carried out by a nurse who makes various adjustments on the G vest to adapt it to the size and morphology of the patient and checks the operation of the ECG electrodes 1 to 10.

[0038] The nurse specifically adjusts the length of the straps S and shows the patient how to close his vest to tighten it on his rib cage using said straps S and the self-gripping fasteners F.

[0039] A physical marker (R in [Fig. 3b]) is placed by the nurse on the garment (felt-tip pen mark, physical marker such as a pin) to allow the patient to correctly position the vest G later. For example, when putting on the vest, the patient must align this marker R with their sternum; the nurse positions this marker accordingly during the initial fitting session.

[0040] All data stored using the APP application module is accessible to the patient via a "My Space" page in the MA application module ([Fig. 5b]). A button B1 on this page also allows the patient to trigger an emergency call to the SAMU (Emergency Medical Service).

[0041] The UTC processing and communication unit of the G vest and the APP application module are configured to exchange bidirectionally, using the short-range connectivity and communication means of the TP personal terminal (Wifi, Bluetooth or any other short-range communication technology).

[0042] In particular, the APP application module allows the patient to trigger an acquisition of ECG signals by sensors 1 to 10 of the G vest if he experiences symptoms which make him fear the beginning of a fainting spell (activation of a button B2 on the "My space" page - [Fig.5b]).

[0043] An actuation push button (not shown) may also be provided on the G vest to allow the patient to trigger this acquisition directly by a physical action on the G vest.

[0044] When it receives a trigger command, the UTC unit activates and energizes electrodes 1 to 10 (step A in [Fig. 6]). It records the ECG signals (spot recording, i.e., over a short period - typically a few seconds, in any case less than one minute and preferably less than 30 s) and transmits these signals to the APP application module (step B).

[0045] The APP application module then implements on the point ECG recording thus acquired a pre-analysis processing which allows the received signals to be categorized according to their degree of severity (step C).

[0046] Such treatments on ECG signals are classically known and have for example been described in the following publication: https: / / www.e-cardiogram.com / ecg-lecture-et-analyse / .

[0047] They rely on a comparison with the patient's reference ECG signals or on data from an initial cardiological analysis.

[0048] Alternatively, the pre-analysis processing can be implemented in whole or in part at the UTC processing and communication unit level. The results are transmitted to the APP application module along with the acquired ECG recording.

[0049] Depending on the result of the pre-analysis, different messages can be displayed by the APP module on the screen of the patient's personal TP terminal (step D).

[0050] For a category of ECG signals, the displayed message will, for example, be a reassuring message ([Fig.7a]):

[0051] "The values ​​obtained are consistent with the initial analysis. The result is good." has just been sent to your cardiologist.

[0052] For another severity category, the message may be as follows:

[0053] "The data from your cardiac analysis are not optimal but do not require No urgent action is needed. A notification has just been sent to the hospital for follow-up.

[0054] For yet another category, the message could be:

[0055] "Your heart condition requires prompt attention. Contact, Contact your cardiologist immediately by clicking here.

[0056] This last sentence is a highlighted link. When the patient clicks on it, this triggers the sending of an alert message from the APP application module to the MD remote interface module (step E). Telephone communication is optionally established between the MD remote module and the patient's personal TP terminal.

[0057] The ME alert message encapsulates different types of data ([Fig.8]):

[0058] - personal data stored by the APP application module,

[0059] - the patient's medical record data, also stored by the module application (APP)

[0060] -1'reference electrocardiogram, also stored by the application module,

[0061] - the ECG signals newly acquired by the G vest,

[0062] - an alphanumeric piece of information that gives the doctor the level of severity detected through the preliminary analysis implemented by the application module,

[0063] - patient location information when available via the personal terminal TP

[0064] - where applicable a message (voice or alphanumeric) from the patient.

[0065] For another category of ECG signals corresponding to an even greater severity, the display on the screen may be:

[0066] "VENTRICULAR ARRHYTHM DISTURBANCES DETECTED. You will receive a Defibrillation shock within seconds.

[0067] Emergency services are on their way. IF AROUND THE PATIENT, DO NOT TOUCH THE PATIENT

[0068] Transmission of the ME alert message to a remote interface module MD is then triggered automatically. However, the patient has a button on the displayed screen to cancel this transmission and indicate that it was an accidental action on their part. The time they have to do so is short: typically less than 30 seconds.

[0069] In this way, the medical center where the MD remote interface module is installed, which receives the ME message, immediately has complete information enabling a doctor to assess the situation and make a first diagnosis.

[0070] The stored personal and medical data is encrypted. It is stored by the APP application module with the security levels required by national legislation.

[0071] An encryption key is given to the patient during initialization. This key is stored in the patient's personal terminal and is called via a secure process (two-factor authentication, for example) each time the patient wants to access their data, for example to complete, modify, or simply view it.

[0072] All this data, as well as the ECG signals, are transmitted to the remote interface MD module according to a communication protocol that is also secure at the required level.

[0073] The G vest is used as follows.

[0074] When the patient experiences symptoms of cardiac distress (chest pain for example), he puts on the G vest, if necessary with assistance, and adjusts it (tightening the straps, closing the hook and loop fasteners, positioning the reference point of the G vest on the patient's sternum).

[0075] When the patient feels ready, they initiate the acquisition of ECG signals. These are transmitted to the APP application module, which, if necessary, triggers (either automatically or at the patient's request) the transmission of the ME alert message to the MD remote interface module.

[0076] The message appears as a pop-up on the MD module's interface, and an audible signal can be emitted to alert the physician. The received data is immediately displayable on the interface and accessible to the on-call physician.

[0077] This allows it to make different decisions:

[0078] - he may decide to send an intervention team to the scene; the responders They will then, if necessary, be able to use the defibrillator in the vest G in place on the patient to shock him (ED electrodes powered by battery B);

[0079] - on the contrary, he may consider that the patient's condition does not justify sending a team and simply order an ambulance for him or even just have a telephone conversation with the patient;

[0080] - in both cases, it can simultaneously trigger the priority booking of a coronary angiography room.

[0081] As will be seen, in one possible option, the triggering of a defibrillation shock can be decided without waiting for the arrival of the intervention team, the center team sending a triggering order to that effect to the APP application module. Furthermore, the shock can be triggered directly by the APP application module based on the severity level detected by the preliminary analysis.

[0082] As will be understood, such a system has many advantages.

[0083] In the event of the onset of illness, it allows a doctor to take action very quickly knowledge of an ECG signal of the patient acquired at the time of pain, at the beginning of the discomfort.

[0084] A first medical diagnosis can be made immediately, without waiting for the intervention of a rescue team.

[0085] The waiting times for treatment are therefore considerably shortened for the patient.

[0086] In addition, since the signals detected are acquired in the first moments of the discomfort, the information they carry is all the more instructive for the doctor who takes note of them.

[0087] Furthermore, the system just described allows the level of patient care to be adapted from the outset. It avoids sending intervention teams to the patient if it is not necessary and immediately triggers the booking of a coronary angiography suite if an emergency coronary angiography is required.

[0088] The G vest can also be used for educational purposes, to teach a patient to monitor themselves regularly.

[0089] It should also be noted that a patient equipped with such a vest will not hesitate to use it immediately. This contributes to better prevention of Sudden Cardiac Death.

[0090] The invention has been described above in the preferred case where the ECG sensors are integrated into a vest. However, other types of clothing can be considered for performing spot ECG recordings on a patient.

Claims

Demands

1. A detection and alert system for patients at high cardiac risk comprising: - a garment (G) with ECG sensors, said garment (G) comprising a processing and communication unit (CTU) adapted to communicate with a patient's personal terminal, - an application module (APP) adapted to be stored and executed by a processor of such a patient's personal terminal, - a remote interface module (MD), characterized in that the garment (G) and / or the application module (APP) comprise means for triggering a one-time ECG recording and transmitting it to the application module (APP) when the patient feels the need, the application module (APP) being configured to allow the storage of the patient's personal and medical data, as well as at least one previous reference ECG recording,said application module (APP) is also configured to transmit to a remote interface module (MD) an alert message encapsulating: - personal and medical data thus stored, - the reference ECG recording also stored, and - the point-by-point ECG recording performed.

2. System according to claim 1, wherein the garment (G) further incorporates defibrillator plates.

3. System according to claim 1, comprising means for implementing on the acquired point recording a pre-analysis processing which allows the ECG signals to be categorized according to their degree of severity (step C).

4. System according to the preceding claim, wherein the application module (APP) is configured to display different messages on the personal terminal screen depending on the result of the pre-analysis.

5. System according to claim 3, wherein the message transmitted to the remote interface module (RM) encapsulates information on the severity level detected by the pre-analysis implemented by the application module (APP),

6. -System according to claim 1, wherein the message transmitted to the interface module encapsulates location information provided by the personal terminal.

7. A system according to claim 1, wherein the garment (G) is a vest that includes means for its attachment to a rib cage

8. System according to the preceding claim, wherein these means comprise adjustable length straps and / or self-gripping fasteners.

9. System according to claim 7 wherein a major part of the vest is made of an elastic fibre fabric.

10. System according to claim 7, further comprising means for installing a physical marker on the garment (G), in order to enable the patient to position it correctly.

11. Application module downloadable onto a personal terminal, comprising instructions which, when executed by said personal terminal, lead to the transmission to a remote interface module (RM) of an alert message encapsulating - personal and stored medical data, - a stored reference ECG recording, and - a point-in-time ECG recording made by the wearer of a system according to one of the preceding claims.

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