Detection and alert system for a high-risk cardiac patient

Abstract

The present invention relates to a detection and alert system for a garment (G) and an application module (APP) which comprise means for triggering an on-demand ECG recording, the application module (APP) being configured - to allow the storage of personal and medical data of the patient, as well as of at least one prior reference ECG recording, - to transmit, to a remote interface module (MD), an alert message (ME) containing thus stored personal data and medical data, - the reference ECG recording also stored, and - the on-demand ECG recording that has been performed.

Description

[0001] Detection and alert system for patients at high cardiac risk

[0002] General technical field and prior art

[0003] The present invention relates to a detection and alert system for patients at high cardiac risk.

[0004] It is known that the earlier a patient experiencing symptoms of a myocardial infarction receives treatment, the less severe the post-infarction after-effects are likely to be. Furthermore, the faster treatment begins, the lower the risk of sudden death.

[0005] 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. It is only once the patient is present that a doctor can begin to make a diagnosis after performing an ECG. Despite the promptness of the 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.

[0006] In a number of cases, it is also found that the chest pain was misinterpreted by the patient and that the intervention teams were mobilized inappropriately.

[0007] Many portable devices are already known for remotely acquiring electrocardiogram signals from a patient. In particular, clothing (vests or similar garments) with ECG sensors integrated into the fabric and connected to a mobile application on the patient's phone is already available.

[0008] 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.

[0009] We also already know of defibrillator vests that integrate defibrillation electrodes and a charging battery. This type of vest delivers electric shocks to a patient's heart and is worn continuously by the patient to protect them from the potential risk of sudden cardiac death.

[0010] It has already been proposed by the documents

[0011] - Rubel et al. : “Toward personal eHealth in cardiology. Results from the EPI-MEDICS telemedicine project - Journal of Electrocardiology 38 (2005) 100 - 106

[0012] - Krupaviciute et al. «Personal Sensor System Modalities Evaluation for Simplified Electrocardiogram recording in Self-care - Computing in Cardiology, 2010 - IEEE - 541 -544; three-lead systems from which twelve-lead ECG signals are reconstructed (reconstructed ECG and not a standard ECG).

[0013] In practice, this type of configuration (reconstruction ECG) provides degraded information, which does not allow the territory of the infarction to be defined (detection of the culprit artery) unlike what a standard ECG allows.

[0014] Thus, while these systems can detect anomalies, they require practitioners to perform a subsequent acquisition with a standard ECG to allow for a reliable and complete diagnosis.

[0015] This represents a waste of time that can prove very detrimental to the patient.

[0016] General presentation of the invention

[0017] One aim of the invention is to provide a solution to shorten the time required for diagnosis and intervention in cases of acute coronary syndrome symptoms in patients at high cardiac risk.

[0018] Another aim 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.

[0019] Another aim of the invention is to offer a solution enabling the medical staff to direct the patient without wasting time to the right 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.

[0020] 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 of such a personal terminal of the patient, a remote interface module, characterized in that the garment comprises at least ten ECG electrodes allowing the acquisition of a twelve-lead ECG (standard ECG), the garment and / or the application module comprising means to trigger a one-off ECG recording by these electrodes and transmit it to the application module when the patient feels the need, 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,said application module being also configured to transmit to a remote interface module an alert message encapsulating personal and medical data thus stored, the reference ECG recording also stored, and the point-by-point ECG recording made, said garment being an adjustable vest during an initialization step for its adaptation to a size and morphology, said garment further integrating defibrillator pads.

[0021] Thus the invention makes it possible, at the time of pain, at the beginning of discomfort, to easily acquire a complete ECG signal and to immediately transmit these complete ECG signals to a remote physician so that he may be aware of them.

[0022] Because the signals are acquired in the initial moments of the illness, the information they convey is all the more valuable to the physician reviewing them. This avoids any wasted time for the patient. A preliminary medical diagnosis can be made immediately, without having to wait for emergency medical services to arrive, which would be necessary with the Rubel et al. or Krupaviciute et al. systems, where the initial three-lead acquisition is insufficient for a complete and reliable diagnosis.

[0023] Furthermore, the fact that the garment combines ECG electrodes with defibrillator pads also allows for immediate treatment of the patient.

[0024] Thus, the proposed system serves both diagnostic and therapeutic purposes, unlike prior art systems. This results in significant time savings in patient care. This makes the system all the more valuable given that cardiac arrhythmias are often fatal within the first hour of a heart attack.

[0025] According to yet another aspect of the invention, 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.

[0026] The application module is configured, for example, to display different messages on the personal terminal screen depending on the result of the pre-analysis.

[0027] The message transmitted to the remote interface module advantageously encapsulates information on the severity level detected by the pre-analysis implemented by the application module (APP); it can also encapsulate location information provided by the personal terminal.

[0028] Also, the application module is advantageously suited for remotely transmitting a trigger order sent remotely.

[0029] The garment may be a vest which includes means for its attachment to a rib cage, a major part of the vest being made of a fabric with elastic fibers.

[0030] These means may include adjustable length straps and / or hook and loop fasteners.

[0031] A large portion of the vest can be made of elastic fiber fabric. The system may also include means for installing a physical marker on the garment to help the patient position it correctly.

[0032] The invention also relates to an application module of a detection and alert system of the aforementioned type, said module being downloadable onto a personal terminal and comprising means for triggering a one-time ECG recording by the electrodes of a vest of such a system and for storing the recording which is transmitted to it, the application module (APP) being further configured to allow the storage of the patient's personal and medical data, as well as at least one previous reference ECG recording, said module comprising instructions which, when executed by said personal terminal, lead to the transmission to a remote interface module of an alert message encapsulating stored personal and medical data, a stored reference ECG recording, and a one-time ECG recording made by the system's electrodes.

[0033] Brief description of the drawings

[0034] 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: Figure 1 is a schematic representation illustrating a system conforming to an embodiment of the invention;Figure 2 illustrates the arrangement of the ECG sensors and defibrillator plates of a vest according to one possible embodiment of the invention; Figure 3a and Figure 3b illustrate a vest according to one possible embodiment of the invention; Figure 4a and Figure 4b illustrate a vest according to another possible embodiment; Figure 5a and Figure 5b illustrate two example pages of the menu of the application module of a system according to one possible embodiment of the invention; Figure 6 illustrates the successive steps implemented by the application module of a system according to one possible embodiment of the invention; Figure 7a and Figure 7b illustrate two interface pages of the module; Figure 8 illustrates the structure of the message transmitted by the application module to the remote interface module.

[0035] Description of one or more implementation and execution methods

[0036] The system illustrated in Figure 1 comprises:

[0037] - a G-sensor vest with ECG sensors designed to be worn by a patient if they experience the onset of symptoms.

[0038] - an application module (APP) stored and executed by a processor on the patient's personal TP terminal, and

[0039] - a remote MD interface module, which is installed for example in a medical emergency center.

[0040] An example of a configuration for the G vest is illustrated in particular in Figure 2.

[0041] The ECG sensors it incorporates are electrodes and plates integrated into the fabric of the vest G (electrodes numbered 1 to 10). The vest G also includes three defibrillator plates ED. It further integrates 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 the battery B and the UTC processing and communication unit.

[0042] A cable (also not shown) allows the integrated battery to be recharged using a suitable charger that plugs into the mains. The ECG sensors are typically ten in number and allow for 12-lead acquisition. They are positioned on the vest (G) to correspond to the areas of the patient where 12D ECG sensors are conventionally placed. In Figure 2, the ECG sensors and ED plates are positioned on the portion of the vest that corresponds to the patient's rib cage.

[0043] This configuration is also illustrated in Figures 3a and 3b. The vest shown is a crossover vest. Specifically, 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 the vest is closed in a way that positions the precordial ECG sensors 1 to 6 against the chest and the four other peripheral ECG sensors against the patient's back when the vest is put on. The fabric of the vest also contributes to this positioning. A major portion 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.

[0044] 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 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 vest G, along with three ED defibrillator pads. The routing of the CE-marked electrical cables integrated into the fabric of vest G is also shown in these figures.

[0045] The patient's personal TP terminal is, for example, their mobile phone ("smartphone") on which the patient's application module (APP) is downloaded (Figure 5a). This application module is typically available in a version for iPhone® (registered trademark) and in a version for Android® (registered trademark).

[0046] The APP application module typically includes a menu with several pages. When the patient downloads the APP module, a home menu (figure 5a) allows them to save personal data to their APP application (name, surname, date of birth, address, telephone number, social security number, referring cardiologist, trusted person, etc.).

[0047] 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 patient to store previously acquired ECG signals on the TP personal terminal using the same G-vest (including the reference electrocardiogram).

[0048] Typically, medical data is downloaded by medical staff 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 staff during subsequent cardiology consultations.

[0049] The initialization step is, for example, carried out by a nurse who makes various adjustments to 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.

[0050] The nurse specifically adjusts the length of the S straps and shows the patient how to close his vest to tighten it on his rib cage using said S straps and the F hook and loop fasteners.

[0051] A physical marker (R in Figure 3b) is placed by the nurse on the garment (felt 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.

[0052] It should be noted that the fact that the garment is adjusted during an initialization step and is thus adapted to the size and morphology of the patient, helps to obtain quality ECG signals that can be used directly.

[0053] All data stored using the APP application module is accessible to the patient via a "My Space" page within the APP application module (Figure 5b). A button B1 on this page also allows the patient to trigger an emergency call to the SAMU (Emergency Medical Service).

[0054] The UTC processing and communication unit of the G vest and the APP application module are configured to exchange information bidirectionally, using the short-range connectivity and communication means of the TP personal terminal (Wifi, Bluetooth or any other short-range communication technology).

[0055] 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 that make him fear the beginning of a fainting spell (activation of a B2 button on the "My space" page - Figure 5b).

[0056] An activation 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.

[0057] When it receives a trigger command, the UTC unit activates and energizes electrodes 1 to 10 (step A in figure 6). It records the ECG signals (spot recording, i.e. over a short period - typically a few seconds, in any case less than a minute and preferably less than 30 s) and transmits these signals to the APP application module (step B).

[0058] The APP application module then implements on the thus acquired point ECG recording a pre-analysis processing which allows the received signals to be categorized according to their degree of severity (step C).

[0059] 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 / .

[0060] They rely on a comparison with the patient's reference ECG signals or on data from an initial cardiological analysis.

[0061] 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.

[0062] Depending on the result of the pre-analysis, different messages may be displayed by the APP module on the screen of the patient's personal TP terminal (step D).

[0063] For a category of ECG signals, the displayed message will, for example, be a reassuring message (figure 7a):

[0064] "The values ​​obtained are consistent with the initial analysis. The result is good and has just been sent to your cardiologist." For another severity category, the message might be as follows:

[0065] "Your cardiac analysis data is not optimal but does not require urgent action. A notification has just been sent to the hospital for follow-up."

[0066] For yet another category, the message could be:

[0067] "Your heart condition requires prompt attention. Contact your cardiologist immediately by clicking here."

[0068] This last sentence is a highlighted link. When the patient clicks on it, it triggers the APP application module to send an ME alert message to the MD remote interface module (step E). A telephone connection may then be established between the MD remote interface module and the patient's TP personal terminal.

[0069] The ME alert message encapsulates different types of data (Figure 8):

[0070] - personal data stored by the APP application module,

[0071] - the patient's medical record data, also stored by the APP application module,

[0072] - the reference electrocardiogram, also stored by the APP application module,

[0073] - the ECG signals newly acquired by the G-vest,

[0074] - alphanumeric information that gives the doctor the level of severity detected by the preliminary analysis implemented by the APP application module,

[0075] - Patient location information when available via the personal TP terminal,

[0076] - if applicable, a message (voice or alphanumeric) from the patient.

[0077] For another category of ECG signals corresponding to an even greater severity, the display on the screen may be:

[0078] "VENTRICULAR ARRHYTHM DISTURBANCES DETECTED. You will receive a defibrillation shock in the next few seconds."

[0079] Emergency services are on their way. IF AROUND THE PATIENT, DO NOT TOUCH THE PATIENT. The transmission of the ME alert message to a remote interface module (MD) is then automatically triggered. However, the patient has a button on their 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.

[0080] In this way, the medical center where the MD remote interface module is installed, which receives the ME alert message, immediately has complete information enabling a doctor to assess the situation and make an initial diagnosis.

[0081] The personal and medical data stored is encrypted. It is stored by the APP application module with the security levels required by national legislation.

[0082] 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.

[0083] All this data, as well as the ECG signals, are transmitted to the MD remote interface module according to a communication protocol that is also secure at the required level.

[0084] The G vest is used as follows.

[0085] When the patient experiences symptoms of cardiac distress (chest pain for example), he puts on the G vest, if necessary with help, 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).

[0086] When the patient feels ready, they initiate the acquisition of ECG signals. These are transmitted to the application module APP, which, if necessary, triggers (either automatically or at the patient's request) the transmission of the ME alert message to the remote interface module MD.

[0087] The message appears as a pop-up on the MD remote interface module's screen, and an audible signal can be emitted to alert the physician. The received data is immediately displayed on the interface and can be reviewed by the on-call physician. The physician can then make various decisions:

[0088] - he may decide to send an intervention team to the scene; the responders may then, if necessary, use the defibrillator of the G vest in place on the patient to shock him (ED electrodes powered by battery B);

[0089] - 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;

[0090] - in both cases, it can simultaneously trigger the priority booking of a coronary angiography room.

[0091] Also, an order can be sent remotely to typically trigger the taking of a new ECG (control ECG) by the medical team in charge of monitoring the patient remotely, without any intervention on site.

[0092] The triggering of a defibrillation shock can, if necessary, be decided without delay by the remote team.

[0093] In one possible embodiment, the center team sends a trigger command to the APP application module. The shock can also be triggered directly by the APP application module based on the severity level detected by the preliminary analysis.

[0094] As we have seen, such a system has many advantages.

[0095] In the event of the onset of discomfort, it allows a doctor to very quickly become aware of an ECG signal of the patient acquired at the time of the pain, at the beginning of the discomfort.

[0096] An initial medical diagnosis can be made immediately, without waiting for the intervention of a rescue team.

[0097] Therefore, waiting times for treatment are considerably shortened for the patient.

[0098] Furthermore, since the signals detected are acquired in the first moments of the illness, the information they carry is all the more instructive for the doctor who takes note of them.

[0099] 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 unnecessarily and allows for the immediate booking of a coronary angiography suite if an emergency coronary angiography is required.

[0100] The G vest can also be used for educational purposes, to teach a patient how to monitor themselves regularly.

[0101] 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.

[0102] The invention has been described herein in the preferred case where the ECG sensors are integrated into a vest. Other types of clothing can, however, be considered for performing spot ECG recordings on a patient.

[0103] In summary, a novel solution is proposed, which should significantly reduce the mortality rate due to heart rhythm disorders. Indeed, sudden death from these disorders is a major public health issue (more than four to five million deaths worldwide each year).

Claims

1. Demands 1. A cardiac high-risk patient detection and alert system 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 (PT), an application module (APP) adapted to be stored and executed by a processor of such a patient's personal terminal (PT), a remote interface module (RM), characterized in that the garment comprises at least ten ECG electrodes enabling the acquisition of a twelve-lead ECG, the garment (G) and / or the application module (APP) comprising means for triggering a one-time ECG recording by these electrodes and transmitting it to the application module (APP) when the patient deems it necessary, 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) also being configured to transmit to a remote interface module (MD) an alert message (ME) encapsulating: personal data and medical data thus stored, the reference ECG recording also stored, and the point-by-point ECG recording made, said garment (G) being an adjustable vest during an initialization step for its adaptation to a size and morphology, said garment (G) further integrating defibrillator pads.

2. 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).

3. System according to claim 1, wherein the application module (APP) is adapted to remotely transmit a remotely sent trigger command.

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

5. System according to claim 4, wherein the message transmitted to the remote interface module (MD) 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. System according to claim 1, wherein the garment (G) is a vest which includes means for its attachment against 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 (G) is made of an elastic fiber 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. An application module for a detection and alert system according to any one of the preceding claims, said module being downloadable onto a personal terminal (PT) and comprising means for triggering a one-time ECG recording by the electrodes of a vest of such a system and for storing the recording transmitted to it, the application module (APP) further 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) comprising instructions which, when they are executed by said personal terminal (PT), lead to the transmission to a remote interface module (RM) of an alert message (EM) encapsulating: personal data and stored medical data, - a reference ECG recording also stored, and a point ECG recording made by the system's electrodes.

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