WO2004052192A1 - Moniteur de condition physiologique - Google Patents

Moniteur de condition physiologique Download PDF

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Publication number
WO2004052192A1
WO2004052192A1 PCT/US2003/025187 US0325187W WO2004052192A1 WO 2004052192 A1 WO2004052192 A1 WO 2004052192A1 US 0325187 W US0325187 W US 0325187W WO 2004052192 A1 WO2004052192 A1 WO 2004052192A1
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WO
WIPO (PCT)
Prior art keywords
ischemia
patients
electrode
silent
ecg
Prior art date
Application number
PCT/US2003/025187
Other languages
English (en)
Inventor
Eli Bar
Original Assignee
Mcinnis, Patricia
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mcinnis, Patricia filed Critical Mcinnis, Patricia
Priority to AU2003259770A priority Critical patent/AU2003259770A1/en
Publication of WO2004052192A1 publication Critical patent/WO2004052192A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/358—Detecting ST segments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/681—Wristwatch-type devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/363—Detecting tachycardia or bradycardia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/685—Microneedles

Definitions

  • the present invention relates to the monitoring of physiological conditions of an individual, and in particular to devices that can be worn on a long term basis by an individual .
  • the invention relates particularly to the monitoring of a number of conditions associated with cardiac disease. Several of these conditions and their implications will be discussed below, with the numbering in parentheses referring to the references listed at the end of this specification. [0004] The numbers in parentheses identify relevant references that are cited at the end of this specification.
  • Type I Silent Ischemia The first and least common form, type I silent ischemia, occurs in totally asymptomatic patients with obstructive CAD (which may be severe) , and these patients do not experience angina a t any time; some type I patients do not even experience pain in the course of myocardial infarction.
  • Epidemiological studies of sudden death, as well as clinical and postmortem studies of patients with silent myocardial infarction and studies of patients with chronic angina pectoris suggest that many patients with extensive coronary artery obstruction never experience angina pectoris in any of its recognized forms (stable, unstable, or variant) .
  • These patients with type I silent ischemia may be considered to have a defective anginal warning system .
  • Type II Silent Ischemia The form that occurs in patients with documented previous myocardial infarction.
  • Type III Silent Ischemia A frequent form of silent ischemia, occurring in patients with the usual forms of chronic stable angina, unstable angina, and Prinzmetal angina. When monitored, patients with this form of silent ischemia exhibit some episodes of ischemia that are associated with chest discomfort and other episodes that are not—i.e., episodes of silent (asymptomatic) ischemia.
  • the "total ischemic burden” in these patients refers to the total period of ischemia, both symptomatic and_asymptomatic.
  • Transient ST segment depression of 0.1 mV or more that lasts longer than 30 seconds is a very rare finding in normal subjects (4) .
  • Patients with known CAD show a strong correlation between such transient ST segment depression and independent measurements of impaired regional myocardial perfusion and ischemia determined by rubidium-82 uptake as measured by PET.
  • perfusion defects occur in the same myocardial regions during symptomatic and asymptomatic episodes of ST segment depression.
  • Other methods of detecting "silent" ischemia include measurement of the left ventricular ejection fraction with a "nuclear vest" or the presence of regional wall motion abnormalities and perfusion defects on echocardiography or radionuclide scintigraphy (5) .
  • H-ECG Holter ECG recordings
  • H-ECG Detection of spontaneous ischemic episodes during normal daily life by H-ECG has been found to have relevant prognostic implications and can assist in therapeutic decisions. Indeed, H-ECG can also provide findings contributing to define the pathophysiologic mechanisms responsible for transient ischemia in individual patients.
  • H-ECG can also provide findings contributing to define the pathophysiologic mechanisms responsible for transient ischemia in individual patients.
  • monitor leads should always include CM5 (V5), as it is the single lead with the highest sensitivity in relieving ST segment depression, independent of the location of myocardial ischemia.
  • H-ECG recorders able to monitor three leads, and also a system which allows recording of 12 leads, have become available. Nevertheless, the usefulness of more than 2 bipolar leads for improving detection of subendocardial ischemia has been questioned. In one study, the addition of a third H-ECG lead improved sensitivity for detecting subendocardial ischemia only from 94% to 96%. [0019] According to Bayes theorem, the probability that transient ST segment depression on H-ECG actually represents myocardial ischemia varies according to the clinical features of the patient, being as much as greater as higher is the pretest likelihood of CAD.
  • ischemic ST segment changes have been reported in 2% to 30% of asymptomatic apparently healthy subjects, but the vast majority of them will not have significant CAD. A greater severity of ST depression or the simultaneous presence of angina will increase the likelihood that the ECG alteration is actually caused by myocardial ischemia.
  • the ischemic meaning of ST depression on H-ECG is usually established with reference to the presence or absence of hemodynamically significant epicardial coronary artery stenosis at angiography.
  • coronary angiography may not be the ideal "gold-standard" for the interpretation of ST segment depression, because myocardial ischemia can occur in the absence of coronary stenoses, as in microvascular angina or in subocclusive vasospastic angina.
  • H-ECG has low additional diagnostic value in these patients, although it may reveal ischemia in about 10% of those with negative exercise test. These latter are usually patients with a high variability of ischemic threshold, likely due to significant vasomotor changes.
  • _H-ECG may represent the first diagnostic test in patients who are unable to undergo exercise test.
  • H-ECG is useful to define the number, severity and duration of ischemic episodes during normal daily life, as well as their relationship with activity and daily hours.
  • H-ECG has shown that episodes of subendocardial ischemia have a typical circardian distribution, with a first peak in the morning hours and a second peak in the afternoon.
  • H-ECG has also shown that increased myocardial oxygen demand has a predominant role in the induction of ischemia in patients with stable angina, as heart rate (HR) significantly increases prior to ischemia in the majority of episodes, whereas it shows more limited changes in patients with unstable angina.
  • HR heart rate
  • H-ECG has also shown that :
  • HR at the ischemic threshold i.e., 1 mm ST depression
  • HR at 1 mm ST depression presents wide variability among spontaneous episodes
  • H-ECG is also useful to characterize episodes of ST segment depression in patients with cardiac syndrome X (i.e., anginal pain, positive exercise test, angiographically normal coronary arteries) , which is believed to be caused by coronary microvascular disease (13) .
  • Episodes of ST depression in these patients present findings similar to those of stable CAD patients (14, 15).
  • silent myocardial ischemia is clinically important because it is associated with poor prognosis after an event such as an episode of unstable angina or myocardial infarction. Most dramatically, it has been assumed to exist in patients in whom coronary artery disease presents as sudden cardiac death. Silent ischemia has also been found during exercise in survivors of cardiac arrest and in patients with life-threatening arrhythmias. [0034] Detection of silent ischemia is associated with increased risk of cardiac events in several groups of CAD patients
  • Atenolol Silent Ischemia Study 33
  • 306 stable patients with transient ischemia on 48-hour H-ECG were randomized to atenolol or placebo.
  • Total cardiac events at 1-year follow-up occurred less frequently in the group treated with atenolol (11% vs 25%, p ⁇ 0.001).
  • the Asymptomatic Cardiac Ischemia Pilot (ACIP) study (34) was designed to specifically evaluate the feasibility of a trial aimed at assessing the impact of silent ischemia suppression on clinical outcome.
  • ACIP Asymptomatic Cardiac Ischemia Pilot
  • 618 CAD patients who had positive stress test and at least 1 episode of silent ischemia on 48-hour H-ECG were randomised to three strategies of treatment: 1) medical therapy adjusted to suppress angina (angina-guided strategy); 2) medical therapy increased to also suppress silent ischemic episodes (ischemia- guided strategy) ; 3) coronary revascularization (angioplasty or bypass surgery) .
  • ischemia-guided treatment failed to reach a better control of ischemic episodes in this pilot study, as H-ECG at the 1-year follow-up still showed silent ischemia in 64% of patients in the ischemia-guided group versus 69% of patients in the angina-guided group. Ischemic episodes, on the other hand, were suppressed in 57% of patients assigned to revascularization, but it is not clear whether there was any relationship between suppression of ischemia and improved prognosis (35) .
  • ambulatory monitoring for quantitative evaluation of the ischemic patient is hindered by its poor reproducibility and technical difficulties that have not yet been completely overcome.
  • ambulatory monitoring does provide meaningful information about ischemia in IHD patients, as a potential test for those who are unable to exercise, it can detect Prinzmetal' s variant angina and hidden arrhythmias and assess the effectiveness of antiarrhythmic therapy.
  • the present invention provides novel devices for monitoring physiological conditions of the type described above on a long term basis without interfering with the normal activities of the individual.
  • Each such device comprises: a monitoring unit composed of at least one electrode constructed to be placed in contact with the skin of the individual to produce a signal corresponding to the physiological condition, an amplifier coupled to the electrode to amplify the signal produced by the electrode, and a signal jpr cessing unit coupled to .
  • the configuration and programming, of the signal processing unit can be in accordance with principles already known in the art and can use software already known in the art for processing heartbeat pattern signals in order to obtain the desired physiological condition indications.
  • Devices according to the invention will be useful for monitoring patients with known heart disease including ischemic heart disease and various disorders of cardiac rhythm.
  • the devices will provide an easy way for detecting the occurrence and frequency of episodes of myocardial ischemia or arrhythmias.
  • the devices can also be used for evaluation and diagnosis of patients without known heart disease, for example, people who are at risk for coronary disease or those complaining of palpitations who are suspected of having an arrhythmia.
  • Another useful application of the devices is to monitor the efficacy of medical therapy for myocardial silent ischemia or hypertension.
  • other capabilities such as heart rate variability and circadian rhythms analysis will be included.
  • Devices according to the invention can be worn on the wrist or can be adhered to other parts of the body.
  • the devices can also be of the size of a regular wristwatch to be worn on the wrist.
  • _ A _ device, worn on the. wrist can include record_ and ⁇ analyze _ECG_ data and transfer the resulting information via the Internet, telemedicine programs or other method to the physician.
  • the devices can be used to detect both changes in heart rhythm (arrhythmias) and silent myocardial ischemia manifesting as ST-segment changes. Additionally, blood pressure can be monitored on a continuous basis.
  • the patient will be able to activate an event marker (e.g. when chest pain or palpitations are experienced) to allow comparison between subjective symptoms and concomitant ECG recording.
  • the device can also have an "alarm" option. If the device detects a life-threatening abnormality such as severe ischemia or a serious arrhythmia, it will signal the patient to seek medical attention.
  • the device can interact with an Internet-based telemedicine network. This feature will give physicians quick access to data relevant to the care of their patients from anywhere with Internet access (including portable computers and palm pilot) as well as a convenient data storage.
  • Telemedicine is the most advantageous way to create a data base center to transfer patient's history files to a doctor.
  • There are two advantages on this way of work first, for the patient, he can see his medical history file anywhere in the world and can send this information to any doctor in the world to get a second or third opinion.
  • the patient now can decide what doctor he would like to see.
  • this network will give the option to see patients everywhere, to explore the number of patient, to work in a why that will give feedback on the treatment without having to see the jpatient.
  • There_are economic aspects to this_ way pf_working,_ for example fewer office visits and less money to pay. In case of a preventive treatment, continuous feedback meaning less expensive operations and treatment.
  • a telemedicine network can employ a server as the center of information coupled to users via the internet.
  • Each user can have an ID and password and each doctor can have a Doctor ID and password.
  • Each user will buy and use a device according to the invention.
  • the device will transmit information to the center by wireless, or LAN, or a combination thereof.
  • the way of initialization the connection to the center can be manual, automatic or semiautomatic.
  • the center will send an e-mail or beeper message or other type of signal to the doctor.
  • the doctor will log in to his patient file and wil] give his opinion for treatment or other instructions.
  • a device will operate at times selected by the user or automatically or at the first communication opportunity, with any connection method and the information will download to the center.
  • the information will be written into a personal file for storage.
  • the doctor will log onto the patient file and review the information.
  • the doctor can then send a message to the patient to contact him or an e-mail with instruction or an e-mail to the center and the center automatically will call or peep to the patient.
  • the user can access his file and look at the information or send an e-mail with the information to another doctor, and can expose or give a partial or complete access to his file to the other doctor.
  • Patients with silent ischemia have been stratified into three categories.
  • Type I silent ischemia occurs in totally asymptomatic patients with obstructive CAD, which may be severe . . _ S_ me_ type Ijpatients do not even experience j ⁇ air ⁇ in the course of myocardial infarction.
  • Type II silent ischemia occurs in patients with documented previous myocardial infarction.
  • Type III silent ischemia occurs in patients with the usual forms of chronic stable angina.
  • silent ischemia When monitored, patients with this form of silent ischemia exhibit some episodes of ischemia that are associated with chest discomfort and other episodes that are not—i.e., episodes of silent (asymptomatic) ischemia.
  • the "total ischemic burden" in these patients refers to the total period of ischemia, both symptomatic and asymptomatic. Episodes of myocardial ischemia, regardless of whether they are symptomatic or asymptomatic, are of prognostic importance.
  • silent ischemia is associated with an adverse cardiac outcome if the episodes are frequent or accelerating.
  • effective treatment of silent ischemia with medical therapy or revascularization is associated with a substantial reduction in coronary events. Therefor, a simple tool for silent ischemia detection is highly desirable.
  • a device can be worn on the wrist and will detect cardiac problems, such as silent ischemia and infraction, etc. Then, the information generated in the device can be downloaded to a PC or sent to the physician via telemedicine program, e-mail or other methods. In cases of emergency an alarm will be heard.
  • a device according to the invention in the form of a skin patch will detect the same conditions as the wrist device.
  • the electronic circuitry will be in the patch and thus directly on the chest.
  • the patient will periodically download the information generated in the device to a logger.
  • the information will be transferred to the physician via a telemedicine provider.
  • [0063J Devices can perform one or more of the following: continuous ECG monitoring, with myocardial silent ischemia & infraction detection based on ST- segment changes; arrhythmia detection; blood pressure monitoring; heart rate variability monitoring; circadian rhythm monitoring. [0064] These devices can perform: Self initiation data saving; Patient-activated event marking (e.g. when chest pain or palpitations are experienced) ; Manual operation at any time; Data recording and analysis; Auto alarm if the system detects a life-threatening abnormality such as severe ischemia or a serious arrhythmia; Telemedicine or other methods for data downloading.
  • Continuous ECG monitoring with myocardial silent ischemia & infraction detection based on ST- segment changes; arrhythmia detection; blood pressure monitoring; heart rate variability monitoring; circadian rhythm monitoring.
  • These devices can perform: Self initiation data saving; Patient-activated event marking (e.g. when chest pain or palpitations are experienced) ; Manual operation at any time; Data recording and analysis; Auto alarm if the system detects
  • the devices will interact with an Internet-based telemedicine network, allowing quick access for physicians to data relevant to the care of their patients from anywhere with Internet access (including portable computers and palm pilot) , easy data sharing between physicians; and convenient and cheap data storage.
  • Devices according to the invention are characterized by small-size, in the case of the wrist device, a high level of comfort and confidence to the patient, continuous operation; and detection of silent ischemia on a continuous basis. When used with the telemedicine approach, the devices provide feedback for the physician regarding the efficacy of treatment .
  • Devices according to the invention will be useful for monitoring patients with known heart disease including ischemic heart disease and various disorders of cardiac rhythm. For example, the devices will provide an easy way for detecting the occurrence and frequency of episodes of myocardial ischemia or arrhythmias. The devices can also be _ _used for evaluation and diagnosis of patients without. known heart disease.
  • the devices will record ECG data and will detect mainly: deviation in ST segment; duration of the QRS complex; abnormalities of the T wave; changes in Heart Rhythm (HR) ; and, optionally changes in blood pressure detections.
  • the device can perform continuous ECG monitoring. Data can be accumulated and processed continuously to produce physiology information and data analysis to give the doctor enough information to give appropriate treatment to the patient.
  • a device according to the present invention used to monitor blood pressure, it can be associated with a unit for injecting a blood pressure medication into the patient under control of the blood pressure reading, allowing injecting of the minimum required dose of medication.
  • the same procedure can be used if the devices employed to monitor the blood sugar level of a diabetic patient.
  • Figure 1 is a perspective, partly exploded, view of a first embodiment of a monitoring device according to the present invention.
  • Figures 2 and 3 are perspective views illustrating electrode 12 of Figure 1 in greater detail.
  • Figure 4 is a cross-sectional view illustrating one electrode element 32 to a larger scale than Figure 3.
  • Figure 5 is a perspective view of a second electrode assembly, viewed from the side at which the electrode assembly will contact the skin.
  • Figure 6 is a perspective view of the assembly of Figure 5, viewed from the opposite side.
  • Figure 7 is a circuit diagram of one embodiment of an amplifier that can be used in a device according to the present invention.
  • Figure 8 is diagram illustrating an exemplary transfer function of the circuit of figure 7.
  • Figure 9 is a flow diagram illustrating the operation of the device according to the invention.
  • Figure 10 is an elevational, cross-sectional view, taken along line A-A of figure 11, of a second embodiment of a monitoring device according to the present invention.
  • Figure 11 is a top plan view of the embodiment of Figure 10.
  • Figure 12 is a perspective view of the embodiment shown in Figures 10 and 11.
  • FIG. 1 is a perspective, partly exploded, view of a first embodiment of a monitoring device according to the present invention.
  • This device includes a monitoring unit composed of an electrode 12 connected to an electronic unit 14. Electrode 12 and unit 14 are installed in a housing 16.
  • Electronic unit 14 contains an amplifier, a signal processing unit, a memory and a communication unit that can include a receiver and a transmitter. These components are not illustrated in detail and can be constituted by components that are conventional in the art.
  • Housing 16 also contains batteries, operational buttons, including an autodetection button, an event button, a _manual operation button and a timer operation button (not_ shown in Fig. 1) , together with port connections, including one or more of serial ports for applications such as blood pressure monitoring, Sp02, temperature, etc., a printer port, a telephone line connector, an infrared port, a USB port, a port for changing the battery and/or for connection to an external energy source, etc. (none of which are shown in
  • Casing 16 further includes a display 18 that can display the time, date, results of the data processing operations, etc.
  • the monitoring unit is associated with elements 22 for attaching the unit to the wrist of an individual whose physiological condition is to be monitored.
  • Elements 22 can take the form of any conventional bracelet, watchband, or other type of wrist band and can be equipped to sense blood pressure, body temperature, etc.
  • FIGs 2 and 3 are perspective views illustrating electrode 12 of Figure 1 in greater detail. Electrode 12 may be disposable or not.
  • Figure 2 is an exploded view and shows that the electrode is composed of a supporting body 30 made of metal or plastic material and serving as housing for the electronic component. There is a connection to the electrode on the bottom of the device, as shown in Figure 12.
  • Body 30 is provided with a plurality of bores, each of which receives a respective electrode element 32.
  • FIG 4 is a cross-sectional view illustrating one electrode element 32 to a larger scale than Figure 3.
  • Element 32 is composed of an elastic body 40 that acts as a spring when the electrode is brought into contact with the skin of the individual and a metal cap 42 that serves as a vacuum cap, or suction cup.
  • _ Cap 42 is provided at its outer surface with a recess 44 in which a partial vacuum is created when the electrode is pressed against the user's skin.
  • a wire 46 conductively connects metal cap 42 to an associated amplifier.
  • Figure 5 is a perspective view of a second electrode assembly, viewed from the side at which the electrode assembly will contact the skin.
  • This electrode assembly is composed of a support board 50 carrying a plurality of electrode elements 52 in the form of very fine, stiff needles measuring l-100 ⁇ m in diameter and having a length of 0.1-lOmm, and preferably 2- 3mm. Needles 52 are of a size that allows them to penetrate the skin to a depth of possibly 2-3mm in order to establish good electrical contact with the skin without causing injury.
  • Figure 6 is a perspective view of the assembly of Figure 5, viewed from the opposite side.
  • FIG 7 is a circuit diagram of one embodiment of an amplifier that can be used in a device according to the present invention.
  • the amplifier is shown connected to a hairy or other type of electrode pad 70 that may be made of gold or other conductor material and that is an alternative to the electrodes shown in Figures 2-6.
  • the electrode pad is supported by the device casing in order to lie flat against the skin.
  • the amplifier is based on conventional technology employing two operational amplifiers, including a main amplifier and a feedback amplifier.
  • the feedback loop of the main amplifier includes the feedback amplifier and a capacitor that causes the amplifier to function as an integrator.
  • This arrangement reduces the gain of the amplifier at low frequencies in order to keep the relatively large electrode offset voltages within the dynamic range of a 16 bit analog- digital converter, as indicated by the exemplary transfer function shown in Figure 8.
  • the electronic components of the amplifier may be nqunted at one side:_of _a_ ceramic substrate ⁇ . __ having a diameter of 5mm, while the other side of the substrate is covered with a printed gold layer forming electrode 70.
  • the amplifier circuitry can then be sealed in a suitable resin, such as an epoxy.
  • Electrode 70 and the amplifier together form an active electrode in which the close connection between electrode pad 70 and the input to the first operational amplifier allow a maximum S/N ratio to be achieved.
  • the four conductors at the right-hand side of Figure 7 may be solid pins that will be connected to the main body. This apparatus produces a positive displacement between the electrodes and the main housing.
  • the arrangement shown in Figure 7 constitutes an active electrode in that the flat electrode 70 allows the amplifier, or preamplifier, circuitry to be positioned very close to the skin, resulting in a high S/N ratio.
  • the preamplifier may operate according to a locking amplifier method. Using this method gives the option to have a lower signal to noise ratio.
  • the operation of this mechanism is the following: the signal samples are passed through an electronic or mechanical gate that operates at high frequency of 50Hz -
  • Each sample is a freeze of a positioning collecting a frame of a signal.
  • the active electrode of Figure 7 performs all analog signal processing, e.g. amplification and DC rejection, at the active electrode and retains the usual configuration of amplifying the biopotential signal with respect to a reference signal.
  • analog signal processing e.g. amplification and DC rejection
  • Figure 9 is a diagram illustrating the operation and flow of data produced by the data processing unit of a device according to the invention.
  • operation is started by activation_of _a . _start_ button . by the user.
  • This causes the signal being received by the device to be recorded at point 82 and to be subjected to immediate and continuous analysis at point 84.
  • the result of the data analysis is saved for a short time at point 86 and permanently at point 88.
  • the result of the data analysis is applied to point 90 where the result of the data analysis is further analyzed to determine whether the data indicates the existence of a dangerous physiological condition. If such a condition is found to exist, then an emergency alarm is generated at point 92.
  • the data stored at point 88 may then be outputted at point 94 via any suitable communication medium as indicated in figure 9.
  • the data saved at point 86 can be deleted at point 96 at appropriate time intervals.
  • Event recording may be used to record data when the patient feels a chest pain or dizziness or other symptom, in which the patient pushes a button, thereby marking the event (date and time) so the physician will see the ECG and can determine whether the pain that the patient felt was from the heart or had another cause.
  • the event recording will record only events several minutes before the pain and several minutes after.
  • Manual recording can be used when the patient feels pain and wants the physician to examine the event time and its aftermath, or when the physician instructs the patient to record at a specific time and date.
  • FIG. 10-12 Other embodiments of the present invention can be in the form of a patch, as shown for example in Figures 10-12, provided with adhesive material 100 that allows the electrode, or electrodes, 102 to be placed in contact with the skin at any point of the body, for example on the chest.
  • the patch further includes a recorder body 104 and a memory card 106. Electrodes 102 can be disposable. The active electrodes have a quick, .positive,displacement connection to . the device (see_ Figure 12) .
  • the patch shown in Figures 10 and 11 can be positioned to detect various cardiac conditions, such as myocardial silent ischemia, arrhythmia and infarction.

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Abstract

La présente invention a trait à un dispositif pour le contrôle de la condition physiologique d'une personne, le dispositif comportant : une unité de contrôle (14) constituée d'au moins une électrode (12) agencée à être placée en contact avec la peau de la personne en vue de produire un signal correspondant à la condition physiologique, un amplificateur relié à l'électrode en vue de l'amplification du signal produit par l'électrode, et une unité de traitement de signaux pour en déduire une indication de la condition physiologique ; et un organe de fixation (22) pour la fixation de l'unité à la peau de la personne à un emplacement choisi, l'électrode étant en contact avec la peau.
PCT/US2003/025187 2002-12-11 2003-08-13 Moniteur de condition physiologique WO2004052192A1 (fr)

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US43222902P 2002-12-11 2002-12-11
US60/432,229 2002-12-11

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106388809A (zh) * 2016-11-22 2017-02-15 江苏南大五维电子科技有限公司 一种用于心电检测的智能手表
EP3273849A4 (fr) * 2015-03-25 2018-08-15 Samsung Electronics Co., Ltd. Dispositif électronique pouvant être porté sur soi
FR3076703A1 (fr) * 2018-01-16 2019-07-19 Pk Paris Systeme de surveillance corporelle avec adhesif
US10874335B2 (en) 2015-03-25 2020-12-29 Samsung Electronics Co., Ltd Wearable electronic device
FR3106050A1 (fr) * 2020-01-14 2021-07-16 Pkvitality Bracelet pour dispositif de surveillance corporelle

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EP3273849A4 (fr) * 2015-03-25 2018-08-15 Samsung Electronics Co., Ltd. Dispositif électronique pouvant être porté sur soi
US10874335B2 (en) 2015-03-25 2020-12-29 Samsung Electronics Co., Ltd Wearable electronic device
CN106388809A (zh) * 2016-11-22 2017-02-15 江苏南大五维电子科技有限公司 一种用于心电检测的智能手表
FR3076703A1 (fr) * 2018-01-16 2019-07-19 Pk Paris Systeme de surveillance corporelle avec adhesif
WO2019141743A1 (fr) * 2018-01-16 2019-07-25 Pkvitality Système de surveillance corporelle avec adhésif
FR3106050A1 (fr) * 2020-01-14 2021-07-16 Pkvitality Bracelet pour dispositif de surveillance corporelle

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