WO2015048191A1 - Alerte d'événement par actigraphie intégrée dans des données électrocardiographiques - Google Patents

Alerte d'événement par actigraphie intégrée dans des données électrocardiographiques Download PDF

Info

Publication number
WO2015048191A1
WO2015048191A1 PCT/US2014/057305 US2014057305W WO2015048191A1 WO 2015048191 A1 WO2015048191 A1 WO 2015048191A1 US 2014057305 W US2014057305 W US 2014057305W WO 2015048191 A1 WO2015048191 A1 WO 2015048191A1
Authority
WO
WIPO (PCT)
Prior art keywords
actigraphy
sensor
monitor
electrocardiography
extended wear
Prior art date
Application number
PCT/US2014/057305
Other languages
English (en)
Inventor
Gust H. Bardy
Jason Felix
Jon Mikalson Bishay
Original Assignee
Bardy Diagnostics, Inc.
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
Priority claimed from US14/080,725 external-priority patent/US9730593B2/en
Priority claimed from US14/082,108 external-priority patent/US9737224B2/en
Application filed by Bardy Diagnostics, Inc. filed Critical Bardy Diagnostics, Inc.
Publication of WO2015048191A1 publication Critical patent/WO2015048191A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1118—Determining activity level
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1116—Determining posture transitions
    • A61B5/1117—Fall detection
    • 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]
    • 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]
    • A61B5/33—Heart-related electrical modalities, e.g. electrocardiography [ECG] specially adapted for cooperation with other devices
    • 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
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches

Definitions

  • the heart emits electrical signals as a by-product of the propagation of the action potentials that trigger depolarization of heart fibers.
  • An electrocardiogram measures and records such electrical potentials to visually depict the electrical activity of the heart over time.
  • ECG electrocardiogram
  • Electrodes at the end of each lead are placed on the skin over the anterior thoracic region of the patient's body to the lower right and to the lower left of the sternum, on the left anterior chest, and on the limbs.
  • Sensed cardiac electrical activity is represented by PQRSTU waveforms that can be interpreted post-ECG recordation to derive heart rate and physiology.
  • the P-wave represents atrial electrical activity.
  • the QRSTU components represent ventricular electrical activity.
  • An ECG is a tool used by physicians to diagnose heart problems and other potential health concerns.
  • An ECG is a snapshot of heart function, typically recorded over 12 seconds, that can help diagnose rate and regularity of heartbeats, effect of drugs or cardiac devices, including pacemakers and implantable cardioverter-defibrillators (ICDs), and whether a patient has heart disease.
  • ECGs are used in-clinic during appointments, and, as a result, are limited to recording only those heart-related aspects present at the time of recording. Sporadic conditions that may not show up during a spot ECG recording require other means to diagnose them. These disorders include fainting or syncope; rhythm disorders, such as
  • an ECG only provides a partial picture and can be insufficient for complete patient diagnosis of many cardiac disorders.
  • Diagnostic efficacy can be improved, when appropriate, through the use of long-term extended ECG monitoring. Recording sufficient ECG and related physiology over an extended period is challenging, and often essential to enabling a physician to identify events of potential concern. A 30-day observation period is considered the "gold standard" of ECG monitoring, yet achieving a 30-day observation period has proven unworkable because such ECG monitoring systems are arduous to employ, cumbersome to the patient, and excessively costly. Ambulatory monitoring in-clinic is implausible and impracticable.
  • ECG electrodes For instance, the long-term wear of ECG electrodes is complicated by skin irritation and the inability ECG electrodes to maintain continual skin contact after a day or two.
  • Holier monitors are widely used for long-term extended ECG monitoring. Typically, they are used for only 24-48 hours.
  • a typical Holier monitor is a wearable and portable version of an ECG that include cables for each electrode placed on the skin and a separate battery-powered ECG recorder. The cable and electrode combination (or leads) are placed in the anterior thoracic region in a manner similar to what is done with an in- clinic standard ECG machine.
  • the duration of a Holier monitoring recording depends on the sensing and storage capabilities of the monitor, as well as battery life.
  • a "looping" Holier monitor (or event) can operate for a longer period of time by overwriting older ECG tracings, thence “recycling" storage in favor of extended operation, yet at the risk of losing event data.
  • the ZIO XT Patch device uses adhesive sufficiently strong to support the weight of both the monitor and the electrodes over an extended period of time and to resist disadherance from the patient's body, albeit at the cost of disallowing removal or relocation during the monitoring period. Moreover, throughout monitoring, the battery is continually depleted and battery capacity can potentially limit overall monitoring duration.
  • the ZIO Event Card device is a form of downsized Holier monitor with a recorder component that must be removed temporarily during baths or other activities that could damage the non-waterproof electronics. Both devices represent compromises between length of wear and quality of ECG monitoring, especially with respect to ease of long term use, female-friendly fit, and quality of atrial (P- wave) signals.
  • the diagnosis, prognosis, and treatment of medical conditions can be further improved by concomitant recording of ECG and human activity.
  • the correlation of motor activity and cardiovascular stress is important for optimizing and monitoring exercise and rehabilitation progress. Certain movement, such as a fall, may precipitate an episode of heart disease; conversely, heart conditions may restrict a person's movement or alter movement patterns.
  • An actigraphy sensor such as an accelerometer, has conventionally been used as a non-invasive method to monitor sleep, activity and movement.
  • Sleep actigraphs are generally watch-shaped and worn on the wrist of the non-dominant arm, and can be worn for weeks.
  • Activity actigraphs are worn and used similar to a pedometer: around waist, near the hip. They are useful for determining the amount of activity and possibly calories. They can be worn for a number of days.
  • Movement actigraphs are generally larger and worn on the shoulder of the dominant arm. They contain 3-D actigraph as opposed to a single dimension one used in sleep actigraph and activity actigraph, and tend to have a high sample rate and a large memory, as a result they are often used for only a few hours.
  • ECG and movement are beneficial to patient care, and the benefit increases with long-term monitoring. Wearing two separate devices, one for ECG monitoring and another for actigraphy, however, creates its own problems. For example, recordings from two separate devices are generally not synchronized. Also, a patient may misplace the actigraphy sensor, resulting in misinterpretation of movements. For instance, the
  • Germany is a wearable watch-shaped monitoring device that records sleep actigraphy and recognizes sleep/wake rhythm, in addition to reading an ECG and recording heart rate.
  • the SOMNOwatch actigraphy monitor can only store the raw data of a single channel ECG for up to 18 hours, requires a software system to synchronize heart rate with motor activity, and does not record specific movement.
  • an extended wear continuously recording ECG monitor coupled with an actigraphy sensor practicably capable of being worn for a long period of time and correlating cardiovascular events with movements, in both men and women, and capable of recording atrial signals reliably.
  • Physiological monitoring can be provided through a wearable monitor that includes two components, a flexible extended wear electrode patch and a removable reusable monitor recorder.
  • the wearable monitor sits centrally (in the midline) on the patient's chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline (or immediately to either side of the sternum), with its unique narrow
  • actigraphy becomes a recordable actigraphy event occurrence when the movement of the wearable monitor and, therefore, the patient, exceeds a certain criteria threshold of acceleration or deceleration as detected by the actigraphy sensor.
  • One embodiment provides an extended wear electrocardiography and physiological sensor monitor recorder.
  • a sealed housing is adapted to be removably secured into the non- conductive receptacle on a disposable extended wear electrode patch.
  • Electronic circuitry is included within the sealed housing.
  • An externally-powered micro-controller is operable to execute under micro programmable control.
  • An electrocardiographic front end circuit is electrically interfaced to the micro-controller and is operable to sense electrocardiographic signals through electrocardiographic electrodes provided on the disposable extended wear electrode patch.
  • An actigraphy sensor is electrically interfaced with the micro-controller and is operable to sense actigraphy event occurrences based on movement of the sealed housing using an actigraphy event occurrence criteria.
  • Externally-powered flash memory is electrically interfaced with the micro-controller and is operable to store samples of the electrocardiographic signals and samples of the actigraphy event occurrences.
  • a disposable extended wear electrode patch includes a flexible backing formed of an elongated strip of stretchable material with a narrow longitudinal midsection and, on each end. A contact surface at least partially coated with an adhesive dressing is provided as a crimp relief. A pair of electrocardiographic electrodes is conductively exposed on the contact surface of each end of the elongated strip. A non- conductive receptacle is adhered to an outward-facing end of the elongated strip and includes a plurality of electrical pads.
  • a flexible circuit is affixed on each end of the elongated strip as a strain relief and includes a pair of circuit traces electrically coupled to the pair of
  • electrocardiographic electrodes and a pair of the electrical pads.
  • electrocardiography monitor has a sealed housing adapted to be removably secured into the non-conductive receptacle.
  • a micro-controller is operable to execute under micro
  • An actigraphy sensor is electrically interfaced with the micro-controller and is operable to sense actigraphy event occurrences based on movement of the sealed housing using an actigraphy event occurrence criteria.
  • Flash memory is electrically interfaced with the micro-controller and is operable to store samples of the electrocardiographic signals and samples of the movement detected by the actigraphy sensor.
  • the monitoring patch is especially suited to the female anatomy.
  • the narrow longitudinal midsection can fit nicely within the intermammary cleft of the breasts without inducing discomfort, whereas conventional patch electrodes are wide and, if adhesed between the breasts, would cause chafing, irritation, frustration, and annoyance, leading to low patient compliance.
  • the foregoing aspects enhance ECG monitoring performance and quality, facilitating long-term ECG recording, critical to accurate arrhythmia diagnosis.
  • the foregoing aspects enhance comfort in women (and certain men), but not irritation of the breasts, by placing the monitoring patch in the best location possible for optimizing the recording of cardiac signals from the atrium, another feature critical to proper arrhythmia diagnosis.
  • FIGURES 1 and 2 are diagrams showing, by way of examples, an extended wear electrocardiography and actigraphy monitor, including a monitor recorder in accordance with one embodiment, respectively fitted to the sternal region of a female patient and a male patient.
  • FIGURE 3 is a functional block diagram showing a system for remote interfacing of a combined ECG and actigraphy monitor recorder in accordance with one embodiment inserted.
  • FIGURE 4 is a perspective view showing an extended wear electrode patch with the combined monitor recorder in accordance with one embodiment.
  • FIGURE 5 is a perspective view showing the combined monitor recorder of FIGURE
  • FIGURE 6 is a perspective view showing the extended wear electrode patch of FIGURE 4 without a monitor recorder inserted.
  • FIGURE 7 is a bottom plan view of the monitor recorder of FIGURE 4.
  • FIGURE 8 is a top view showing the flexible circuit of the extended wear electrode patch of FIGURE 3 when mounted above the flexible backing.
  • FIGURE 10 is a functional block diagram showing the circuitry of the extended wear electrode patch of FIGURE 4.
  • FIGURE 11 is a flow diagram showing a monitor recorder-implemented method for monitoring ECG data and actigraphy data for use in the monitor recorder of FIGURE 4.
  • FIGURE 12 is a graph showing, by way of example, a typical ECG waveform.
  • FIGURE 13 is a flow diagram showing a method for offloading and converting ECG and other physiological data from of an extended wear electrocardiography and actigraphy monitor in accordance with one embodiment.
  • the electrode patch 15 is shaped to fit comfortably and conformal to the contours of the patient's chest approximately centered on the sternal midline 16 (or immediately to either side of the sternum 13).
  • the distal end of the electrode patch 15 extends towards the Xiphoid process and, depending upon the patient's build, may straddle the region over the Xiphoid process.
  • the proximal end of the electrode patch 15, located under the monitor recorder 14, is below the manubrium and, depending upon patient's build, may straddle the region over the manubrium.
  • the sternum 13 overlies the right atrium of the heart and the placement of the wearable monitor 12 in the region of the sternal midline 13 puts the ECG electrodes of the electrode patch 15 in a location better adapted to sensing and recording P-wave signals than other placement locations, say, the upper left pectoral region or lateral thoracic region or the limb leads.
  • placing the lower or inferior pole (ECG electrode) of the electrode patch 15 over (or near) the Xiphoid process facilitates sensing of ventricular activity and provides superior recordation of the QRS interval.
  • FIGURE 3 is a functional block diagram showing a system 120 for remote interfacing of an extended wear electrocardiography and actigraphy sensor monitor 12 in accordance with one embodiment.
  • the monitor recorder 14 is a reusable component that can be fitted during patient monitoring into a non-conductive receptacle provided on the electrode patch 15, as further described infra with reference to FIGURE 4, and later removed for offloading of stored ECG data or to receive revised programming.
  • the monitor recorder 14 can then be connected to a download station 125, which could be a programmer or other device that permits the retrieval of stored ECG monitoring data, execution of diagnostics on or programming of the monitor recorder 14, or performance of other functions.
  • the monitor recorder 14 has a set of electrical contacts (not shown) that enable the monitor recorder 14 to physically interface to a set of terminals 128 on a paired receptacle 127 of the download station 125.
  • the download station 125 executes a communications or offload program 126 ("Offload") or similar program that interacts with the monitor recorder 14 via the physical interface to retrieve the stored ECG monitoring data or to execute diagnostics on or reprogram the monitor recorder's program memory unit and thereby revise the subsequent operation of the monitor recorder 14.
  • the download station 125 could be a server, personal computer, tablet or handheld computer, smart mobile device, or purpose-built programmer designed specific to the task of interfacing with a monitor recorder 14. Still other forms of download station 125 are possible.
  • the wearable monitor 12 can interoperate with other devices, as further described in detail in commonly-assigned U.S. Patent application, entitled “Remote Interfacing of Extended Wear Electrocardiography and Physiological Sensor Monitor,” Serial No. 14/082,071, filed November 15, 2013, pending, the disclosure of which is incorporated by reference.
  • middleware Upon retrieving stored ECG monitoring data from a monitor recorder 14, middleware first operates on the retrieved data to adjust the ECG capture quality, as necessary, and to convert the retrieved data into a format suitable for use by third party post-monitoring analysis software, as further described infra with reference to FIGURE 13.
  • the formatted data can then be retrieved from the download station 125 over a hard link 135 using a control program 137 ("Ctl") or analogous application executing on a personal computer 136 or other connectable computing device, via a communications link (not shown), whether wired or wireless, or by physical transfer of storage media (not shown).
  • the personal computer 136 or other connectable device may also execute middleware that converts ECG data and other information into a format suitable for use by a third-party post-monitoring analysis program, as further described infra with reference to FIGURE 13.
  • middleware that converts ECG data and other information into a format suitable for use by a third-party post-monitoring analysis program, as further described infra with reference to FIGURE 13.
  • EMRs electronic medical records
  • the download station 125 is able to directly interface with other devices over a computer communications network 121, which could be some combination of a local area network and a wide area network, including the Internet, over a wired or wireless connection.
  • a client-server model could be used to employ a server 122 to remotely interface with the download station 125 over the network 121 and retrieve the formatted data or other information.
  • the server 122 executes a patient management program 123 ("Mgt") or similar application that stores the retrieved formatted data and other information in a secure database 124 cataloged in that patient's EMRs 134.
  • the patient management program 123 could manage a subscription service that authorizes a monitor recorder 14 to operate for a set period of time or under pre-defined operational parameters, such as described in commonly- assigned U.S. Patent application, entitled "Self-Authenticating Electrocardiography
  • the patient management program 123 also maintains and safeguards the secure database 124 to limit access to patient EMRs 134 to only authorized parties for appropriate medical or other uses, such as mandated by state or federal law, such as under the Health Insurance Portability and Accountability Act (HIPAA) or per the European Union's Data Protection Directive.
  • HIPAA Health Insurance Portability and Accountability Act
  • a physician may seek to review and evaluate his patient's ECG monitoring data, as securely stored in the secure database 124.
  • the physician would execute an application program 130 ("Pgm"), such as a post-monitoring ECG analysis program, on a personal computer 129 or other connectable computing device, and, through the application 130, coordinate access to his patient's EMRs 134 with the patient management program 123.
  • Pgm application program 130
  • Other schemes and safeguards to protect and maintain the integrity of patient EMRs 134 are possible.
  • the electrode patch 15 incorporates features that significantly improve wearability, performance, and patient comfort throughout an extended monitoring period.
  • the electrode patch 15 is susceptible to pushing, pulling, and torqueing movements, including compressional and torsional forces when the patient bends forward, and tensile and torsional forces when the patient leans backwards.
  • the electrode patch 15 incorporates strain and crimp reliefs, such as described in commonly-assigned U.S. Patent application, entitled “Extended Wear Electrocardiography Patch,” Serial No. 14/080,717, filed November 14, 2013, pending, the disclosure of which is incorporated by reference.
  • the cut-outs 22 and longitudinal midsection 23 help minimize interference with and discomfort to breast tissue, particularly in women (and gynecomastic men).
  • the cut-outs 22 and longitudinal midsection 23 further allow better conformity of the electrode patch 15 to sternal bowing and to the narrow isthmus of flat skin that can occur along the bottom of the intermammary cleft between the breasts, especially in buxom women.
  • the cut-outs 22 and longitudinal midsection 23 help the electrode patch 15 fit nicely between a pair of female breasts in the intermammary cleft. Still other shapes, cut-outs and conformities to the electrode patch 15 are possible.
  • the monitor recorder 14 removably and reusably snaps into an electrically non- conductive receptacle 25 during use.
  • the monitor recorder 14 contains electronic circuitry for recording and storing the patient's electrocardiography as sensed via a pair of ECG electrodes provided on the electrode patch 15, as further described infra beginning with reference to FIGURE 9, as well as described in commonly-assigned U.S. Patent Application, entitled “Extended Wear Ambulatory Electrocardiography and Physiological Sensor Monitor,” Serial No. 14/080,725, filed November 14, 2013, pending, the disclosure which is incorporated by reference.
  • the non-conductive receptacle 25 is provided on the top surface of the flexible backing 20 with a retention catch 26 and tension clip 27 molded into the non-conductive receptacle 25 to conformably receive and securely hold the monitor recorder 14 in place.
  • the monitor recorder 14 includes a sealed housing that snaps into place in the non- conductive receptacle 25.
  • FIGURE 5 is a perspective view showing the monitor recorder 14 of FIGURE 4.
  • the sealed housing 50 of the monitor recorder 14 intentionally has a rounded isosceles trapezoidal-like shape 52, when viewed from above, such as described in commonly- assigned U.S. Design Patent application, entitled “Electrocardiography Monitor,” Serial No. 29/472,046, filed November 7, 2013, pending, the disclosure of which is incorporated by reference.
  • the edges 51 along the top and bottom surfaces are rounded for patient comfort.
  • the sealed housing 50 is approximately 47 mm long, 23 mm wide at the widest point, and 7 mm high, excluding a patient-operable tactile-feedback button 55.
  • the sealed housing 50 can be molded out of polycarbonate, ABS, or an alloy of those two materials.
  • the button 55 is waterproof and the button's top outer surface is molded silicon rubber or similar soft pliable material.
  • a retention detent 53 and tension detent 54 are molded along the edges of the top surface of the housing 50 to respectively engage the retention catch 26 and the tension clip 27 molded into non-conductive receptacle 25.
  • Other shapes, features, and conformities of the sealed housing 50 are possible.
  • the electrode patch 15 is intended to be disposable.
  • the monitor recorder 14, however, is reusable and can be transferred to successive electrode patches 15 to ensure continuity of monitoring.
  • the placement of the wearable monitor 12 in a location at the sternal midline 16 (or immediately on either side of the sternum 13) benefits long-term extended wear by removing the requirement that ECG electrodes be continually placed in the same spots on the skin throughout the monitoring period. Instead, the patient is free to place an electrode patch 15 anywhere within the general region of the sternum 13.
  • the patient's skin is able to recover from the wearing of an electrode patch 15, which increases patient comfort and satisfaction, while the monitor recorder 14 ensures ECG monitoring continuity with minimal effort.
  • a monitor recorder 14 is merely unsnapped from a worn out electrode patch 15, the worn out electrode patch 15 is removed from the skin, a new electrode patch 15 is adhered to the skin, possibly in a new spot immediately adjacent to the earlier location, and the same monitor recorder 14 is snapped into the new electrode patch 15 to reinitiate and continue the ECG monitoring.
  • FIGURE 6 is a perspective view showing the extended wear electrode patch 15 of FIGURE 4 without a monitor recorder 14 inserted.
  • a flexible circuit 32 is adhered to each end of the flexible backing 20.
  • a distal circuit trace 33 and a proximal circuit trace (not shown) electrically couple ECG electrodes (not shown) to a pair of electrical pads 34.
  • the electrical pads 34 are provided within a moisture-resistant seal 35 formed on the bottom surface of the non-conductive receptacle 25.
  • a battery compartment 36 is formed on the bottom surface of the non- conductive receptacle 25, and a pair of battery leads (not shown) electrically interface the battery to another pair of the electrical pads 34.
  • the battery contained within the battery compartment 35 can be replaceable, rechargeable or disposable.
  • FIGURE 7 is a bottom plan view of the monitor recorder 14 of FIGURE 4.
  • a cavity 58 is formed on the bottom surface of the sealed housing 50 to accommodate the upward projection of the battery compartment 36 from the bottom surface of the non-conductive receptacle 25, when the monitor recorder 14 is secured in place on the non-conductive receptacle 25.
  • a set of electrical contacts 56 protrude from the bottom surface of the sealed housing 50 and are arranged in alignment with the electrical pads 34 provided on the bottom surface of the non-conductive receptacle 25 to establish electrical connections between the electrode patch 15 and the monitor recorder 14.
  • a seal coupling 57 circumferentially surrounds the set of electrical contacts 56 and securely mates with the moisture-resistant seal 35 formed on the bottom surface of the non-conductive receptacle 25.
  • the placement of the flexible backing 20 on the sternal midline 16 also helps to minimize the side-to-side movement of the wearable monitor 12 in the left- and right-handed directions during wear.
  • a layer of non-irritating adhesive such as hydrocolloid, is provided at least partially on the underside, or contact, surface of the flexible backing 20, but only on the distal end 30 and the proximal end 31.
  • the underside, or contact surface of the longitudinal midsection 23 does not have an adhesive layer and remains free to move relative to the skin.
  • the longitudinal midsection 23 forms a crimp relief that respectively facilitates compression and twisting of the flexible backing 20 in response to compressional and torsional forces.
  • Other forms of flexible backing crimp reliefs are possible.
  • FIGURE 8 is a top view showing the flexible circuit 32 of the extended wear electrode patch 15 of FIGURE 4 when mounted above the flexible backing 20.
  • a distal ECG electrode 38 and proximal ECG electrode 39 are respectively coupled to the distal and proximal ends of the flexible circuit 32.
  • a strain relief 40 is defined in the flexible circuit 32 at a location that is partially underneath the battery compartment 36 when the flexible circuit 32 is affixed to the flexible backing 20. The strain relief 40 is laterally extendable to counter dis lodgment of the ECG electrodes 38, 39 due to tensile and torsional forces.
  • a pair of strain relief cutouts 41 partially extend transversely from each opposite side of the flexible circuit 32 and continue longitudinally towards each other to define in 'S '-shaped pattern, when viewed from above.
  • the strain relief respectively facilitates longitudinal extension and twisting of the flexible circuit 32 in response to tensile and torsional forces.
  • Other forms of circuit board strain relief are possible.
  • FIGURE 9 is a functional block diagram showing the component architecture of the circuitry 60 of the monitor recorder 14 of FIGURE 4.
  • the circuitry 60 is externally powered through a battery provided in the non-conductive receptacle 25 (shown in FIGURE 6).
  • Both power and raw ECG signals, which originate in the pair of ECG electrodes 38, 39 (shown in FIGURE 8) on the distal and proximal ends of the electrode patch 15, are received through an external connector 65 that mates with a corresponding physical connector on the electrode patch 15.
  • the external connector 65 includes the set of electrical contacts 56 that protrude from the bottom surface of the sealed housing 50 and which physically and electrically interface with the set of pads 34 provided on the bottom surface of the non-conductive receptacle 25.
  • the external connector includes electrical contacts 56 for data download, microcontroller communications, power, analog inputs, and a peripheral expansion port.
  • the external connector 65 also serves as a physical interface to a download station that permits the retrieval of stored ECG monitoring data, communication with the monitor recorder 14, and performance of other functions.
  • the microcontroller 61 includes a program memory unit containing internal flash memory that is readable and writeable. The internal flash memory can also be programmed externally.
  • the micro-controller 61 draws power externally from the battery provided on the electrode patch 15 via a pair of the electrical contacts 56.
  • the microcontroller 61 connects to the ECG front end circuit 63 that measures raw cutaneous electrical signals and generates an analog ECG signal representative of the electrical activity of the patient's heart over time.
  • the circuitry 60 of the monitor recorder 14 also includes a flash memory 62, which the micro-controller 61 uses for storing ECG monitoring data and other physiology and information.
  • the flash memory 62 also draws power externally from the battery provided on the electrode patch 15 via a pair of the electrical contacts 56. Data is stored in a serial flash memory circuit, which supports read, erase and program operations over a communications bus.
  • the flash memory 62 enables the microcontroller 61 to store digitized ECG data.
  • the communications bus further enables the flash memory 62 to be directly accessed externally over the external connector 65 when the monitor recorder 14 is interfaced to a download station.
  • the circuitry 60 of the monitor recorder 14 further includes an actigraphy sensor 64 implemented as a 3 -axis accelerometer.
  • the accelerometer may be configured to generate interrupt signals to the microcontroller 61 by independent initial wake up and free fall events, as well as by device position.
  • actigraphy becomes a recordable actigraphy event occurrence when the movement of the wearable monitor 12 and, therefore, the patient, exceeds a certain criteria threshold of acceleration or deceleration as detected by the actigraphy sensor 64, as further described infra with reference to FIGURE 11.
  • the actigraphy provided by the accelerometer can be used during post-monitoring analysis to correct the orientation of the monitor recorder 14 if, for instance, the monitor recorder 14 has been inadvertently installed upside down, that is, with the monitor recorder 14 oriented on the electrode patch 15 towards the patient's feet, as well as for other event occurrence analyses.
  • the microcontroller 61 includes an expansion port that also utilizes the
  • an external physiology sensor can be provided as part of the circuitry 60 of the monitor recorder 14, or can be provided on the electrode patch 15 with communication with the micro-controller 61 provided over one of the electrical contacts 56.
  • the physiology sensor can include an Sp0 2 sensor, blood pressure sensor, temperature sensor, respiratory rate sensor, glucose sensor, airflow sensor, volumetric pressure sensing, or other types of sensor or telemetric input sources.
  • an airflow sensor is described in commonly-assigned U.S. Patent Application, entitled “Self-Contained Personal Air Flow Sensing Monitor," Serial No.
  • a wireless interface for interfacing with other wearable (or implantable) physiology monitors, as well as data offload and programming can be provided as part of the circuitry 60 of the monitor recorder 14, or can be provided on the electrode patch 15 with communication with the micro-controller 61 provided over one of the electrical contacts 56, such as described in commonly-assigned U.S. Patent application, entitled “Remote Interfacing of Extended Wear Electrocardiography and Physiological Sensor Monitor,” Serial No.
  • the circuitry 60 of the monitor recorder 14 includes patient-interfaceable components, including a tactile feedback button 66, which a patient can press to mark events or to perform other functions, and a buzzer 67, such as a speaker, magnetic resonator or piezoelectric buzzer.
  • the buzzer 67 can be used by the microcontroller 61 to output feedback to a patient such as to confirm power up and initiation of ECG monitoring.
  • Still other components as part of the circuitry 60 of the monitor recorder 14 are possible, such as described in commonly-assigned U.S. Patent Application, entitled "Extended Wear
  • FIGURE 10 is a functional block diagram showing the circuitry 70 of the extended wear electrode patch 15 of FIGURE 4.
  • the circuitry 70 of the electrode patch 15 is electrically coupled with the circuitry 60 of the monitor recorder 14 through an external connector 74.
  • the external connector 74 is terminated through the set of pads 34 provided on the bottom of the non-conductive receptacle 25, which electrically mate to corresponding electrical contacts 56 protruding from the bottom surface of the sealed housing 50 to electrically interface the monitor recorder 14 to the electrode patch 15.
  • the circuitry 70 of the electrode patch 15 performs three primary functions.
  • a battery 71 is provided in a battery compartment formed on the bottom surface of the non- conductive receptacle 25.
  • the battery 71 is electrically interfaced to the circuitry 60 of the monitor recorder 14 as a source of external power.
  • the unique provisioning of the battery 71 on the electrode patch 15 provides several advantages. First, the locating of the battery 71 physically on the electrode patch 15 lowers the center of gravity of the overall wearable monitor 12 and thereby helps to minimize shear forces and the effects of movements of the patient and clothing.
  • the housing 50 of the monitor recorder 14 is sealed against moisture and providing power externally avoids having to either periodically open the housing 50 for the battery replacement, which also creates the potential for moisture intrusion and human error, or to recharge the battery, which can potentially take the monitor recorder 14 off line for hours at a time.
  • the electrode patch 15 is intended to be disposable, while the monitor recorder 14 is a reusable component. Each time that the electrode patch 15 is replaced, a fresh battery is provided for the use of the monitor recorder 14, which enhances ECG monitoring performance quality and duration of use.
  • the architecture of the monitor recorder 14 is open, in that other physiology sensors or components can be added by virtue of the expansion port of the microcontroller 61.
  • the pair of ECG electrodes 38, 39 respectively provided on the distal and proximal ends of the flexible circuit 32 are electrically coupled to the set of pads 34 provided on the bottom of the non-conductive receptacle 25 by way of their respective circuit traces 33, 37.
  • the signal ECG electrode 39 includes a protection circuit 72, which is an inline resistor that protects the patient from excessive leakage current.
  • the circuitry 70 of the electrode patch 15 includes a cryptographic circuit 73 to authenticate an electrode patch 15 for use with a monitor recorder 14.
  • the cryptographic circuit 73 includes a device capable of secure authentication and validation. The cryptographic device 73 ensures that only genuine, non-expired, safe, and authenticated electrode patches 15 are permitted to provide monitoring data to a monitor recorder 14, such as described in commonly-assigned U.S. Patent Application, entitled “Self- Authenticating Electrocardiography Monitoring Circuit,” Serial No. 14/082,066, filed
  • FIGURE 11 is a flow diagram showing a monitor recorder-implemented method 100 for monitoring ECG data for use in the monitor recorder 14 of FIGURE 4.
  • the microcontroller 61 executes a power up sequence (step 101).
  • the voltage of the battery 71 is checked, the state of the flash memory 62 is confirmed, both in terms of operability check and available capacity, and microcontroller operation is diagnostically confirmed.
  • an authentication procedure between the microcontroller 61 and the electrode patch 15 are also performed.
  • an iterative processing loop (steps 102-109) is continually executed by the microcontroller 61.
  • the ECG frontend 63 (shown in FIGURE 9) continually senses the cutaneous ECG electrical signals (step 103) via the ECG electrodes 38, 29 and is optimized to maintain the integrity of the P-wave.
  • a sample of the ECG signal is read (step 104) by the microcontroller 61 by sampling the analog ECG signal output front end 63.
  • FIGURE 12 is a graph showing, by way of example, a typical ECG waveform 110.
  • the x-axis represents time in approximate units of tenths of a second.
  • the j-axis represents cutaneous electrical signal strength in approximate units of millivolts.
  • the P-wave 111 has a smooth, normally upward, that is, positive, waveform that indicates atrial depolarization.
  • the QRS complex usually begins with the downward deflection of a Q-wave 112, followed by a larger upward deflection of an R-wave 113, and terminated with a downward waveform of the S- wave 114, collectively representative of ventricular depolarization.
  • the T-wave 115 is normally a modest upward waveform, representative of ventricular depolarization, while the U-wave 116, often not directly observable, indicates the recovery period of the Purkinje conduction fibers.
  • the R-to-R interval represents the ventricular rate and rhythm
  • the P-to-P interval represents the atrial rate and rhythm
  • the PR interval is indicative of atrioventricular (AV) conduction time and abnormalities in the PR interval can reveal underlying heart disorders, thus representing another reason why the P-wave quality achievable by the extended wear ambulatory electrocardiography and physiological sensor monitor described herein is medically unique and important.
  • AV atrioventricular
  • Each sampled ECG signal, in quantized and digitized form, is temporarily staged in buffer (step 105), pending compression preparatory to storage in the flash memory 62 (step 105).
  • Step 109 Processing continues (step 109), so long as the monitoring recorder 14 remains connected to the electrode patch 15 (and storage space remains available in the flash memory 62), after which the processing loop is exited and execution terminates. Still other operations and steps are possible.
  • the monitor recorder 14 also receives data from the actigraphy sensor 64.
  • the data is received in a conceptually-separate execution thread as part of the iterative processing loop (step 102-109) continually executed by the micro-controller 61.
  • the actigraphy sensor 64 monitors a patient's movement and detects if there is a notable movement event, such as an event that may trigger or reflect a cardiovascular episode, that needs to be recorded as part of the monitoring (step 140).
  • a notable movement is a fall.
  • an accelerometer records a g-force (g) equivalent to 1 g along the axis perpendicular towards the earth.
  • the accelerometer records a g-force equivalent to zero, or very close to zero, along the axis perpendicular towards the earth, during the freefall.
  • a notable movement is a sudden acceleration or deceleration that is indicative of a forceful, traumatic impact on a patient, in which the g-force along at least one axis exceeds a certain threshold, for example, 2.5 g.
  • a certain threshold for example, 2.5 g.
  • Still another example is a series of accelerations and decelerations exceeding a certain threshold of g-force, indicating intensive physical exertions that may put undue stresses to heart. Other examples are possible. If no such notable movement events are detected, the method 100 proceeds to step 109.
  • the actigraphy sensor 64 provides an interrupt signal to the microprocessor 61, and the microprocessor 61 reads the data sample that includes the movement event and converts into a digital signal by the onboard ADC of the microcontroller 61 (step 141).
  • This design provides an automatic time-correlation between a movement event and its
  • step 102 if movement data is detected (step 140), a sample of the movement telemetry is read (step 141) by the microcontroller 61 and, if necessary, converted into a digital signal by the onboard ADC of the microcontroller 61.
  • Each sampled movement event, in quantized and digitized form, is temporarily staged in buffer (step 142), tending compression preparatory to storage in the flash memory subsystem 62 (step 143).
  • the compressed digitized movement sample is again buffered (step 144), then written to the flash memory subsystem 62 (step 145) using the communications bus. Processing continues (step 109), so long as the monitoring recorder 14 remains connected to the electrode patch 15 (and storage space remains available in the flash memory 62), after which the processing loop is exited and execution terminates. Still other operations and steps are possible.
  • the monitor recorder 14 stores ECG data and other information in the flash memory subsystem 62 (shown in FIGURE 9) using a proprietary format that includes data
  • FIGURE 13 is a flow diagram showing a method 150 for offloading and converting ECG and other physiological data from an extended wear electrocardiography and physiological sensor monitor 12 in accordance with one embodiment.
  • the method 150 can be implemented in software and execution of the software can be performed on a download station 125, which could be a programmer or other device, or a computer system, including a server 122 or personal computer 129, such as further described supra with reference to FIGURE 3, as a series of process or method modules or steps.
  • the method 150 will be described in the context of being performed by a personal computer 136 or other connectable computing device (shown in FIGURE 3) as middleware that converts ECG data and other information into a format suitable for use by a third-party post-monitoring analysis program. Execution of the method 150 by other computer system or download station 125 would be analogous mutatis mutandis.
  • the download station 125 is connected to the monitor recorder 14 (step 151), such as by physically interfacing to a set of terminals 128 on a paired receptacle 127 or by wireless connection, if available.
  • the data stored on the monitor recorder 14, including ECG and physiological monitoring data, other recorded data, and other information are retrieved (step 152) over a hard link 135 using a control program 137 ("Ctl") or analogous application executing on a personal computer 136 or other connectable computing device.
  • the data retrieved from the monitor recorder 14 is in a proprietary storage format and each datum of recorded ECG monitoring data, as well as any other physiological data or other information, must be converted, so that the data can be used by a third-party post-monitoring analysis program.
  • Each datum of ECG monitoring data is converted by the middleware (steps 153-159) in an iterative processing loop.
  • the ECG datum is read (step 154) and, if necessary, the gain of the ECG signal is adjusted (step 155) to compensate, for instance, for relocation or replacement of the electrode patch 15 during the monitoring period.
  • other physiological data including patient events, such as a fall, peak activity level, sleep detection, detection of patient activity levels and states, and so on, may be recorded along with the ECG monitoring data.
  • actigraphy data may have been sampled by the actigraphy sensor 64 based on a sensed event occurrence, such as a sudden change in orientation due to the patient taking a fall.
  • the monitor recorder 14 will embed the actigraphy data samples into the stream of data, including ECG monitoring data, that is recorded to the flash memory 62 by the micro-controller 61.
  • the actigraphy data is temporally matched to the ECG data to provide the proper physiological context to the sensed event occurrence.
  • the three-axis actigraphy signal is turned into an actionable event occurrence that is provided, through conversion by the middleware, to third party post-monitoring analysis programs, along with the ECG recordings
  • physiological data (or other information) are possible.
  • other physiological data recorded is also read (step 156) and is time-correlated to the ECG monitoring data.
  • blood pressure recorded by a blood pressure sensor would be temporally matched to the monitoring ECG data to provide the proper physiological context to the sensed event occurrence.
  • Other types of processing of the other physiological data are possible.
  • any other physiological data (or other information) that has been embedded into the recorded ECG monitoring data is read (step 156) and time-correlated to the time frame of the ECG signals that occurred at the time that the other physiological data (or other information) was noted (step 157).
  • the ECG datum, signal gain adjusted, if appropriate, and other physiological data, if applicable and as time- correlated, are stored in a format suitable to the backend software (step 158) used in post- monitoring analysis.
  • the other physiological data if apropos, is embedded within an unused ECG track.
  • the SCP-ENG standard allows multiple ECG channels to be recorded into a single ECG record.
  • the monitor recorder 14 though, only senses one ECG channel.
  • the other physiological data can be stored into an additional ECG channel, which would otherwise be zero-padded or altogether omitted.
  • physiological data is actigraphy data.
  • the backend software would then be able to read the other physiological data in context with the single channel of ECG monitoring data recorded by the monitor recorder 14, provided the backend software implemented changes necessary to interpret the other physiological data. Still other forms of embedding of the other
  • FIGURE 14 is a flow diagram showing a method 160 for processing actigraphy data collected by a monitor recorder 14 in accordance with one embodiment.
  • Physiological data includes actigraphy data, ECG monitoring data and, if applicable, other physiological data.
  • Physiological data is offloaded and converted as described supra with reference to FIGURE 13.
  • the converted physiological data is then retrieved by the backend software (step 161).
  • the backend software processes the retrieved physiological data to identify recorded actigraphy event occurrences (step 162).
  • actigraphy becomes a recordable actigraphy event occurrence when the movement of the wearable monitor 12 and, therefore, the patient, exceeds a certain criteria threshold of acceleration or deceleration as detected by the actigraphy sensor 64.
  • movement of a patient is continual, but, for the most part, not rising to the level of an event occurrence. For instance, the rise and fall of a patient's chest attendant to regular breathing constitutes movement, yet such movement is ordinary and expected.
  • the actigraphy sensor 64 would be set per a stored criteria to ignore those movement failing to warrant recordation (as event occurrences) through onboard parameters that specify the conditions under which actigraphy will be recorded as event occurrences, such as described supra with reference to FIGURE 11.
  • the onboard parameters could be set to trigger actigraphy recordation when the g- force along at least one axis exceeds a certain criteria threshold, for example, 2.5 g, although other thresholds could be used.
  • a certain criteria threshold for example, 2.5 g, although other thresholds could be used.
  • actigraphy event occurrences are considered to be actionable, that is, of sufficient importance to warrant flagging for further consideration to a following physician.
  • the occurrence of a fall event could signal the onset of myocardial infarction in the patient, or, under different circumstances, could be found to have been precipitated by myocardial infarctional onset.
  • the occurrence of an actigraphy event is identified as actionable based on a filtering criteria.
  • Actionable actigraphy event occurrences include, for instance, sleep, awake, hyperactivity, and falling, although other actionable actigraphy event occurrences are possible.
  • Both the occurrence of the actigraphy event, that is, the fall, and the patient's ECG monitoring data, as well as any other available physiological data, may be of diagnostic interest and are identified (step 163).
  • a physician would scrutinize the identified physiological data, including the ECG monitoring data and the actigraphy event occurrence, for accompanying indications of myocardial infarction, or other concerns relating to syncope and related maladies.
  • physiological data may include data recorded by other physiology sensors including the Sp0 2 sensor, blood pressure sensor, temperature sensor, glucose sensor, airflow sensor, volumetric pressure sensing, or other types of sensor or telemetric input sources.
  • a blood pressure sensor were available to record blood pressure substantially concurrent to the monitoring of ECG and actigraphy, the retrieved blood pressure data would be temporally aligned with the physiological data relating to the patient's fall and thereby help to diagnostic efficacy.
  • these other physiological data may be processed according to diagnostic and prognostic values of the data (step 164).
  • the information about the actigraphy events such as the time the events occurred, the duration of the events, the nature of the event (intensity of the fall, for example), together with the other approximately physiological data relevant for diagnosis, are output for consultation by a physician or another medical professional (step 165). Still other operations and steps are possible. Other types of processing the other physiological data are possible.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Physiology (AREA)
  • Dentistry (AREA)
  • Cardiology (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

L'invention concerne la surveillance physiologique, qui peut être réalisée au moyen d'un capteur d'actigraphie (64) intégré dans un moniteur d'électrocardiographie (12) qui met en corrélation un mouvement et des données électrocardiographiques. La surveillance physiologique peut être réalisée au moyen d'un moniteur pouvant être porté (12) qui comprend deux éléments, un timbre d'électrode souple à port prolongé (15) et un enregistreur de moniteur réutilisable amovible (14). Le moniteur (12) est placé au centre sur la poitrine du patient le long du sternum (13). Le patient peut placer un timbre (15) à n'importe quel endroit dans la région générale du sternum (13). La survenue d'événements d'actigraphie est surveillée par l'enregistreur (14) au moyen d'un capteur d'actigraphie (64). L'actigraphie devient une survenue d'événement d'actigraphie enregistrable lorsque le mouvement du moniteur (12) et, par conséquent, du patient (10, 11), dépasse un seuil de critère d'accélération ou de décélération détectée par le capteur d'actigraphie (64). Certaines survenues d'événement d'actigraphie sont considérées comme pratiques, d'importance suffisante pour garantir un marquage pour une observation ultérieure par un médecin traitant.
PCT/US2014/057305 2013-09-25 2014-09-24 Alerte d'événement par actigraphie intégrée dans des données électrocardiographiques WO2015048191A1 (fr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US201361882403P 2013-09-25 2013-09-25
US61/882,403 2013-09-25
US14/080,725 US9730593B2 (en) 2013-09-25 2013-11-14 Extended wear ambulatory electrocardiography and physiological sensor monitor
US14/080,717 2013-11-14
US14/080,725 2013-11-14
US14/080,717 US9545204B2 (en) 2013-09-25 2013-11-14 Extended wear electrocardiography patch
US14/082,108 US9737224B2 (en) 2013-09-25 2013-11-16 Event alerting through actigraphy embedded within electrocardiographic data
US14/082,108 2013-11-16

Publications (1)

Publication Number Publication Date
WO2015048191A1 true WO2015048191A1 (fr) 2015-04-02

Family

ID=52744435

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2014/057305 WO2015048191A1 (fr) 2013-09-25 2014-09-24 Alerte d'événement par actigraphie intégrée dans des données électrocardiographiques

Country Status (1)

Country Link
WO (1) WO2015048191A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20180039698A (ko) * 2015-09-11 2018-04-18 후쿠다 덴시 가부시키가이샤 생체 정보 측정 장치
US10758139B2 (en) 2015-10-27 2020-09-01 Cardiologs Technologies Sas Automatic method to delineate or categorize an electrocardiogram
US11147500B2 (en) 2015-10-27 2021-10-19 Cardiologs Technologies Sas Electrocardiogram processing system for delineation and classification
US11331034B2 (en) 2015-10-27 2022-05-17 Cardiologs Technologies Sas Automatic method to delineate or categorize an electrocardiogram
US11672464B2 (en) 2015-10-27 2023-06-13 Cardiologs Technologies Sas Electrocardiogram processing system for delineation and classification

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090076397A1 (en) * 2007-09-14 2009-03-19 Corventis, Inc. Adherent Emergency Patient Monitor
WO2009142975A1 (fr) * 2008-05-23 2009-11-26 Medtronic, Inc. Algorithme de détection de chute utilisant un accéléromètre à trois axes
US8200320B2 (en) * 2006-03-03 2012-06-12 PhysioWave, Inc. Integrated physiologic monitoring systems and methods
EP2589333A1 (fr) * 2011-11-04 2013-05-08 BIOTRONIK SE & Co. KG Appareil et système de surveillance cardiaque cutanée à long terme

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8200320B2 (en) * 2006-03-03 2012-06-12 PhysioWave, Inc. Integrated physiologic monitoring systems and methods
US20090076397A1 (en) * 2007-09-14 2009-03-19 Corventis, Inc. Adherent Emergency Patient Monitor
WO2009142975A1 (fr) * 2008-05-23 2009-11-26 Medtronic, Inc. Algorithme de détection de chute utilisant un accéléromètre à trois axes
EP2589333A1 (fr) * 2011-11-04 2013-05-08 BIOTRONIK SE & Co. KG Appareil et système de surveillance cardiaque cutanée à long terme

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
ABDALLAH DAOUD: "Fall Detection using Shimmer Technology and Multiresolution Analysis", 2 August 2013 (2013-08-02), XP055157469, Retrieved from the Internet <URL:https://decibel.ni.com/content/docs/DOC-26652> [retrieved on 20141208] *
ALEXANDER M. CHAN ET AL: "Wireless patch sensor for remote monitoring of heart rate, respiration, activity, and falls", 2013 35TH ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY (EMBC), 1 July 2013 (2013-07-01), pages 6115 - 6118, XP055157468, ISBN: 978-1-45-770216-7, DOI: 10.1109/EMBC.2013.6610948 *
DORTHE B SAADI ET AL: "Heart Rhythm Analysis using ECG recorded with a Novel Sternum based Patch Technology -A Pilot Study", CARDIOTECHNIX 2013 - INTERNATIONAL CONGRESS ON CARDIOVASCULAR TECHNOLOGIES, 20 September 2013 (2013-09-20), XP055157450 *
IMAD LIBBUS: "Adherent Cardiac Monitor with Wireless Fall Detection for Patients with Unexplained Syncope", ABSTRACTS OF THE FIRST AMA-IEEE MEDICAL TECHNOLOGY CONFERENCE ON INDIVIDUALIZED HEATHCARE, 22 May 2010 (2010-05-22), XP055157414 *

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20180039698A (ko) * 2015-09-11 2018-04-18 후쿠다 덴시 가부시키가이샤 생체 정보 측정 장치
CN107949323A (zh) * 2015-09-11 2018-04-20 福田电子株式会社 生物信息测定装置
EP3348189A4 (fr) * 2015-09-11 2019-03-13 Fukuda Denshi Co., Ltd. Dispositif de mesure d'informations biologiques
KR102287701B1 (ko) * 2015-09-11 2021-08-09 후쿠다 덴시 가부시키가이샤 생체 정보 측정 장치
US11123001B2 (en) 2015-09-11 2021-09-21 Fukuda Denshi Co., Ltd. Biological information measurement device
US10758139B2 (en) 2015-10-27 2020-09-01 Cardiologs Technologies Sas Automatic method to delineate or categorize an electrocardiogram
US11147500B2 (en) 2015-10-27 2021-10-19 Cardiologs Technologies Sas Electrocardiogram processing system for delineation and classification
US11331034B2 (en) 2015-10-27 2022-05-17 Cardiologs Technologies Sas Automatic method to delineate or categorize an electrocardiogram
US11672464B2 (en) 2015-10-27 2023-06-13 Cardiologs Technologies Sas Electrocardiogram processing system for delineation and classification

Similar Documents

Publication Publication Date Title
US10413205B2 (en) Electrocardiography and actigraphy monitoring system
US11786159B2 (en) Self-authenticating electrocardiography and physiological sensor monitor
US11701045B2 (en) Expended wear ambulatory electrocardiography monitor
US11445966B2 (en) Extended wear electrocardiography and physiological sensor monitor
US10172534B2 (en) Remote interfacing electrocardiography patch
US11445967B2 (en) Electrocardiography patch
WO2015048194A1 (fr) Moniteur personnel autonome de détection du débit d&#39;air
WO2015048191A1 (fr) Alerte d&#39;événement par actigraphie intégrée dans des données électrocardiographiques
US12089943B2 (en) Electrocardiography patch

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 14781015

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 14781015

Country of ref document: EP

Kind code of ref document: A1