WO2000074564A1 - Appareil de surveillance physio-cinetique portatif - Google Patents

Appareil de surveillance physio-cinetique portatif Download PDF

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Publication number
WO2000074564A1
WO2000074564A1 PCT/US1999/018296 US9918296W WO0074564A1 WO 2000074564 A1 WO2000074564 A1 WO 2000074564A1 US 9918296 W US9918296 W US 9918296W WO 0074564 A1 WO0074564 A1 WO 0074564A1
Authority
WO
WIPO (PCT)
Prior art keywords
data
housing
recorder
patient
ambulatory
Prior art date
Application number
PCT/US1999/018296
Other languages
English (en)
Inventor
Bruce E. Del Mar
Original Assignee
Del Mar Avionics
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 Del Mar Avionics filed Critical Del Mar Avionics
Publication of WO2000074564A1 publication Critical patent/WO2000074564A1/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
    • A61B5/68—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
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6822—Neck
    • 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
    • A61B5/24—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]
    • A61B5/333—Recording apparatus specially adapted therefor
    • A61B5/335—Recording apparatus specially adapted therefor using integrated circuit memory devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/411—Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0462—Apparatus with built-in sensors
    • A61B2560/0468—Built-in electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • 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
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/282—Holders for multiple electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7232—Signal processing specially adapted for physiological signals or for diagnostic purposes involving compression of the physiological signal, e.g. to extend the signal recording period

Definitions

  • the invention relates to apparatus and processes for
  • the invention disclosed herein consists of a miniature, solid state
  • the invention discloses novel improvements in data recorder designs specifically related to data collection and analysis of physiological data during sports activity rather than
  • the invention polo, auto racing, and other physical fitness activity in general.
  • Electrocardiocorder AVSEPO
  • Arrhythmiagraph The 136 patent specifically
  • the 785 patent disclosed a small, hip/side mounted tape recorder for ambulatory
  • the Kelen 934 patent disclosed a hip/side
  • the system further includes an analysis module
  • An analysis module in the recorder has counters to accumulate the number
  • the system is further configured to sense
  • the invention employs Fourier Analysis of short overlapping segments of ECG signal to create a three-dimensional
  • patent discloses a method for digital signal averaging of selected signals
  • recorder may also receive rough treatment from dropping to the floor or exposure to other hostile environments.
  • this invention can create more reliable long-term monitoring of physiological signals.
  • the ambulatory data recorder of the invention incorporates design
  • this invention utilizes compact, contiguous, and high continuity integrated circuitry
  • A-to-D converters ; a CPU operating system; a physiological sensor elements;
  • acceleration detector element printed circuit, flash memory and DC power to record
  • the recorder system has multiple sensor attachments and serial and parallel output porting to download recorded data
  • PC Personal Computer
  • Another object is to provide for higher electrical continuity of sensor contacts
  • Yet another object, of the invention is the provision for recording ambulatory
  • Still another object is to provide an independent ambulatory physiological recording means and process that does not need to change patient's daily routine
  • Another object is to provide ambulatory physiological recording without
  • Yet another object is to reduce the cost of obtaining ambulatory physiological
  • Still another object of the invention is to provide an ambulatory physiological
  • the recorder can provide information on body orientation, activity and acceleration
  • Another object is to provide an ambulatory physiological recorder that is pliable
  • Another object is to utilize a lanyard extending around the athletes neck to lend
  • Yet another object is to provide a readily available ambulatory physiological
  • test can be conducted in the physician's office as an adjunct to other long-term
  • Figure 1 illustrates a pictorial view of the ambulatory physio-kinetic monitor
  • Figure 2 illustrates a pictorial view of Fig 1 , without rib cage for clarity of view
  • Figure 3 illustrates a solitary, perspective view of the self contained
  • Figure 4 illustrates a top side, perspective, exploded view of the ambulatory
  • Figure 5 illustrates a bottom side, perspective, exploded view of the
  • FIG. 6 depicts a block flow diagram of the PCB components and functions
  • e Figure 7 depicts a block flow diagram of the software recording process of
  • FIG. 8 depicts an electronic schematic of the microprocessor controller
  • Figure 9 depicts an electronic schematic of the physiological sensor analog
  • Figure 10 depicts an electronic schematic of the acceleration sensor circuit
  • Figures land 2 illustrate a frontal view of the orientation of the ambulatory
  • physio-kinetic monitor mounted on a patient's chest and adapted for use as an
  • the monitor 18 is mounted on a ambulatory electrocardiograph (ECG) monitor.
  • ECG electrocardiograph
  • Rib cage 21 is illustrated in Fig 1
  • the invention monitor consists of a square or
  • monitor housing 22 °l rectangular shaped, environmentally sealed box or enclosure, about the size of a package of cigarettes, designated as monitor housing 22, and is provided with four
  • housing 22 is illustrated in
  • housing 22 could be virtually any shaped polygon, triangle, square, rectangle, pentagon, hexagon, circle,
  • Housing 22 is also provided with a second or alternative mounting means in the
  • Fig 1 and is raised for use, as illustrated in Fig 2.
  • a comfortable fitting lanyard or neck band 25 is caused to pass through ring element 23 and is secured around the
  • neck band 25 and ring 23 ' combination is alone sufficient to support monitor housing and attachments thereto, the neck band 25 is
  • the adhesive pads 24 through 30 may be detached and the mounting
  • the monitor housing 22 to the patient's chest, but they also hold the housing and
  • electrode leads are allowed to fly about or even move a little, electrical
  • discontinuities may well occur in contacts between electrodes and housing, thereby causing much artifact and resulting in incorrect or difficult to interpret data readings.
  • housing 22 is disposed on the PCB within housing 22. If housing 22 is allowed to fly
  • the ECG monitor housing 22 is provided with at
  • Each lead provides ECG input from conventional, electrolyte filled, first
  • Electrodes 48, 50, 52, and 54 are attached to the patient's skin by electrode adhesive pads 48, 50, 52, and 54.
  • first, second and third positive leads is recorded on a first, second and third
  • Fig 3 depicts the housing alone
  • Fig 4
  • FIG. 22 illustrates a top exploded view of housing 22 and Fig 5 illustrates a bottom exploded
  • Monitor housing 22 consists of a plastic molded, rectangular base 74 covered by a plastic molded lid 76 that is attached to base 72 by four screws 78 and is sealed to the base via a rubber grommet 80 that circumvents the periphery of lid 76.
  • Input/output interface 64 is configured to snugly fit within a cutout 82 of base 74,
  • Housing 22 is designed with curved circumferential edges 60 and corners 62 to avoid sharp
  • the curved surfaces also inhibit catching or tearing of clothing worn over
  • housing 22 is preferably
  • housing 22 may be constructed of harder
  • the plastic or hard rubber input/output interface 64 is configured with four buttons
  • An output receptacle 73 is configured for receipt of a universal serial buss (USB) element.
  • USB universal serial buss
  • cardiovascular data and related kinetic data is accumulated in flash memory over a period of time, the thusly accumulated data is downloaded from the physio-
  • housing 22 components contained within housing 22 are assembled on a first and second dual sided and parallel printed circuit boards (PCB) 86 and 88 coupled together
  • PCB printed circuit boards
  • PCB input leads 92 and output leads 94 couple
  • PCB 88 to input/output interface 64.
  • PCB 86 and 88 are configured to fit snugly
  • lid 76 and seal 80 secure lid 76 to base 74 through appropriate screw holes 77; a protective, decorative cover 79 hides screw heads thereunder and also provides a
  • the system power supply consists of a battery compartment 96 containing a
  • lid 76 molded on the underside of lid 76.
  • Adhesive pads 24 - 30 are uniquely constructed and designed to be throw
  • adhesive pad 24 - 30 is designed with a peal away plastic or paper cover 105, that
  • Pimple 110 male insert, for convenient attachment to a respective dimple II2, female receptacle, of housing 22.
  • Pimple 110 is attached to plastic shield 109 and sticky pad
  • FIG 6 a block flow diagram of the functional electronic components of PCB's 86 and 88 is delineated.
  • the block flow diagram in Fig 6 is designed for a very small and compact, lightweight digital recorder.
  • circuit on PCB's 86 and 88 in Fig 6 is designed to accommodate and record a
  • Monitor 18 is specifically designed with the concept
  • Monitor 18 physically possesses its own attached sensor
  • the circuit is designed to operate in an ambulatory environment for a recording period of at least twenty-four (24) hours.
  • the transducers 202 i.e. positive electrode sensors 40, 42, 44 and common
  • negative/ground electrode 46 utilized in any particular application will depend on
  • ECG electrocardiograph
  • EEG electroencephalograph
  • EMG electromyograph
  • transducer would be acceleration sensors; for pressure recording, the transducer would be a pressure transducer; and for skin temperature recording, the transducer
  • transducer would be a thermal type transducer. In the specific embodiment at
  • an acceleration sensor 203 mounted on the PCB 88 appropriately detects
  • the activity monitor, accelerometer is a device to augment traditional Holter
  • the output of the motion sensing device is an analog signal, as is the ECG signal, that represents the "G' (gravity) acceleration on the body.
  • the signals are conditioned to be in the signal level range for typical Holter recording technology
  • the patient's activity can be viewed or printed out using a Holter scanner I conjunction with relative ECG strips, trends or full disclosure
  • Typical Holter scanners offer trends of heart rate, ST levels and arrhythmia. The trends can be combined with patient activity trends to show
  • Transducer 202 feeds a data signal into an analog signal conditioner 204,
  • the signal conditioning function is further characterized by the type of input, the necessary gain, the bandwidth, the
  • analog signal conditioner 204 is to amplify transducer 202
  • Analog to digital converter (A/D) 206 primary function is to sample analog signals on each cycle of a sample clock 208.
  • the A/D output is a digital value represented by one's and zero's on a set of parallel lines.
  • the typical number of lines or bits would be eight (8).
  • CPU central processing unit
  • Central processor unit 212 in the preferred embodiment is a standard CPU used in micro processor and controller environments. CPU 212 function is to read
  • ROM read only memory
  • CPU 212 is the heart of any stored program controller. CPU 212
  • Read only memory (ROM) 214 stores program instructions to control
  • USB universal serial bus port
  • Random access memory (RAM) 222 is used by the program executed by
  • CPU 212 for temporary storage of data.
  • RAM 222 is a scratch pad
  • Flash memory 224 is a type of nonvolatile memory used in digital devices to store large amounts of data in a small volume. Some of the properties of this type
  • a built in real time clock 226 makes effective system time and data
  • Fig 7 a flow chart of the software/firmware operation of the ambulatory physio-kinetic monitor succinctly delineates the logic process for
  • USB 220 USB 220
  • Figure 8 delineates the system controller schematic.
  • the data acquisition, storage and processing is accomplished and controlled by a microprocessor 300 on
  • PCB 86 as regulated by a real time clock 301. Data is accumulated a bank of flash
  • USB universal serial buss
  • LED driver circuits 310 are provided to give operator visual display of functions and operations of the controller circuit.
  • transducer 40 Data received for example by electrode, transducer 40 is first
  • Second and third channels 402 and 404 are filtered through an op amp 406 and amplified by op amp 408 to be passed through a two pole low pass filter 410 and followed by a second two pole low pass filter 412 to yield an analog millivolt output 414.
  • Second and third channels 402 and 404 are filtered through an op amp 406 and amplified by op amp 408 to be passed through a two pole low pass filter 410 and followed by a second two pole low pass filter 412 to yield an analog millivolt output 414.
  • Second and third channels 402 and 404 are filtered through an op amp 406 and amplified by op amp 408 to be passed through a two pole low pass filter 410 and followed by a second two pole low pass filter 412 to yield an analog millivolt output 414.
  • Second and third channels 402 and 404 are filtered through an op amp 406 and amplified by op amp 408 to be passed through a two pole low pass filter 410
  • Figure 10 delineates the accelerometer, activity monitor circuit.
  • piezoresistive accelerometer chip 500 is used to measure body movement. The
  • output signal is conditioned in a balanced bridge 502 and produces a signal that is
  • the activity monitor is calibrated to operate in
  • the signal conditioner circuit 504 it is powered by the system 1.5volt power supply converted to a 3 volt level in Fig 9, and is configured to be running for a 24 hour period or more.
  • the activity monitor
  • the system consists of the activity monitor sensor, i.e. accelerometer, the power supply/system battery, and an electrode adapter.
  • the electrode adapter connects

Landscapes

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

Abstract

Cet appareil de surveillance physio-cinétique portatif, étanche à l'humidité, autonome, compact et de longue durée (22), est conçu pour être mis en place directement sur le corps d'un athlète ou d'une personne s'adonnant à la culture physique, de préférence au voisinage immédiat de l'organe ou du système à surveiller. Il est dissimulé sous les vêtements et fixé, afin de se maintenir en place, de manière confortable à l'aide de plaquettes cutanées adhésives (24, 30). Au moins trois électrodes positives (32-36) et une électrode négative commune (38) partent de l'appareil de surveillance et sont fixées par des plages de connexion adhésives semblables et jetables, ces électrodes servant à la détection de données physiologiques, par exemple des données électrocardiographiques. L'appareil de surveillance renferme un accéléromètre permettant de détecter les mouvements corporels et de mémoriser les données sur le troisième canal de données électrocardiographiques.
PCT/US1999/018296 1999-06-03 1999-09-30 Appareil de surveillance physio-cinetique portatif WO2000074564A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US32532199A 1999-06-03 1999-06-03
US09/325,321 1999-06-03

Publications (1)

Publication Number Publication Date
WO2000074564A1 true WO2000074564A1 (fr) 2000-12-14

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003005904A2 (fr) * 2001-07-12 2003-01-23 Stichting Katholieke Universiteit Dispositif, systeme et procede permettant de caracteriser un schema de mouvements
GB2394294A (en) * 2002-10-18 2004-04-21 Cambridge Neurotechnology Ltd Cardiac sensor with accelerometer
EP1523269A1 (fr) * 2002-07-23 2005-04-20 Datascope Investment Corp. Appareil de surveillance medicale porte par le patient
EP1595497A1 (fr) * 2004-05-05 2005-11-16 Drakeley Consulting Llc Dispositif terminal et réseau de transmission de données sans fil
WO2009087350A1 (fr) * 2008-01-04 2009-07-16 Central Manchester University Hospitals Nhs Foundation Trust Dispositif électrocardiographique et procédé
US8301219B2 (en) 2008-07-16 2012-10-30 The General Hospital Corporation Patient monitoring systems and methods
US8467859B2 (en) 2006-09-07 2013-06-18 Telozo Gmbh Method and device for deriving and evaluating cardiovascular information from curves of the cardiac current, in particular for applications in telemedicine
CN108652616A (zh) * 2018-05-17 2018-10-16 清华大学 一种柔性可穿戴心电监护装置

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4635646A (en) * 1983-11-10 1987-01-13 Ascher Gilles Portable apparatus for monitoring heart activity
US5957854A (en) * 1993-09-04 1999-09-28 Besson; Marcus Wireless medical diagnosis and monitoring equipment

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4635646A (en) * 1983-11-10 1987-01-13 Ascher Gilles Portable apparatus for monitoring heart activity
US5957854A (en) * 1993-09-04 1999-09-28 Besson; Marcus Wireless medical diagnosis and monitoring equipment

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL1018530C2 (nl) * 2001-07-12 2003-06-11 Stichting Katholieke Univ Inrichting, samenstel en werkwijze voor het karakteriseren van een bewegingspatroon.
WO2003005904A3 (fr) * 2001-07-12 2003-08-07 Stichting Katholieke Univ Dispositif, systeme et procede permettant de caracteriser un schema de mouvements
WO2003005904A2 (fr) * 2001-07-12 2003-01-23 Stichting Katholieke Universiteit Dispositif, systeme et procede permettant de caracteriser un schema de mouvements
EP1523269A4 (fr) * 2002-07-23 2009-03-04 Datascope Investment Corp Appareil de surveillance medicale porte par le patient
EP1523269A1 (fr) * 2002-07-23 2005-04-20 Datascope Investment Corp. Appareil de surveillance medicale porte par le patient
GB2394294A (en) * 2002-10-18 2004-04-21 Cambridge Neurotechnology Ltd Cardiac sensor with accelerometer
US6881191B2 (en) 2002-10-18 2005-04-19 Cambridge Neurotechnology Limited Cardiac monitoring apparatus and method
EP1595497A1 (fr) * 2004-05-05 2005-11-16 Drakeley Consulting Llc Dispositif terminal et réseau de transmission de données sans fil
US8467859B2 (en) 2006-09-07 2013-06-18 Telozo Gmbh Method and device for deriving and evaluating cardiovascular information from curves of the cardiac current, in particular for applications in telemedicine
WO2009087350A1 (fr) * 2008-01-04 2009-07-16 Central Manchester University Hospitals Nhs Foundation Trust Dispositif électrocardiographique et procédé
US8473040B2 (en) 2008-01-04 2013-06-25 Central Manchester University Hospitals Nhs Foundation Trust Electrocardiographic device and method
US8301219B2 (en) 2008-07-16 2012-10-30 The General Hospital Corporation Patient monitoring systems and methods
CN108652616A (zh) * 2018-05-17 2018-10-16 清华大学 一种柔性可穿戴心电监护装置

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