US20210275110A1 - Systems For Synchronizing Different Devices To A Cardiac Cycle And For Generating Pulse Waveforms From Synchronized ECG and PPG Systems - Google Patents

Systems For Synchronizing Different Devices To A Cardiac Cycle And For Generating Pulse Waveforms From Synchronized ECG and PPG Systems Download PDF

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Publication number
US20210275110A1
US20210275110A1 US17/135,936 US202017135936A US2021275110A1 US 20210275110 A1 US20210275110 A1 US 20210275110A1 US 202017135936 A US202017135936 A US 202017135936A US 2021275110 A1 US2021275110 A1 US 2021275110A1
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United States
Prior art keywords
calibration
signaling
cardiac cycle
signal
ppg
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US17/135,936
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English (en)
Inventor
C. Mike Robert Tomlinson
Eric Raman
David Heckadon
Raji Raman
Iain Hueton
Kevin Peterson
James Wilber
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Hemocept Inc
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Rubyelf LLC
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Priority to US17/135,936 priority Critical patent/US20210275110A1/en
Priority to PCT/US2021/027161 priority patent/WO2021211636A1/en
Priority to US17/229,741 priority patent/US11801016B2/en
Priority to KR1020237036839A priority patent/KR20230152820A/ko
Priority to EP21788309.9A priority patent/EP4135572A4/en
Priority to CA3177642A priority patent/CA3177642A1/en
Priority to MX2022012886A priority patent/MX2022012886A/es
Priority to MX2022012799A priority patent/MX2022012799A/es
Priority to JP2022562720A priority patent/JP7345681B2/ja
Priority to CA3177643A priority patent/CA3177643A1/en
Priority to KR1020227035775A priority patent/KR102595127B1/ko
Priority to AU2021255871A priority patent/AU2021255871B2/en
Priority to BR112022020829A priority patent/BR112022020829A2/pt
Priority to KR1020227035787A priority patent/KR102595937B1/ko
Priority to US17/229,759 priority patent/US11896405B2/en
Priority to BR112022020839A priority patent/BR112022020839A2/pt
Priority to EP21788382.6A priority patent/EP4135573A4/en
Priority to JP2022562719A priority patent/JP7346753B2/ja
Priority to PCT/US2021/027158 priority patent/WO2021211634A1/en
Priority to KR1020237036508A priority patent/KR20230151085A/ko
Priority to AU2021256968A priority patent/AU2021256968B2/en
Publication of US20210275110A1 publication Critical patent/US20210275110A1/en
Assigned to RUBYELF LLC reassignment RUBYELF LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: WILBER, JAMES, HUETON, IAIN, Raman, Raji, PETERSON, KEVIN, Raman, Eric, HECKADON, David, TOMLINSON, C. MIKE
Assigned to HEMOCEPT INC. reassignment HEMOCEPT INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: RubyElf, LLC
Priority to AU2023202053A priority patent/AU2023202053A1/en
Priority to AU2023202274A priority patent/AU2023202274A1/en
Priority to JP2023142748A priority patent/JP2023159456A/ja
Priority to JP2023143448A priority patent/JP2023164937A/ja
Priority to US18/385,294 priority patent/US20240130692A1/en
Priority to US18/429,323 priority patent/US20240188903A1/en
Pending legal-status Critical Current

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Definitions

  • the present invention relates in general to systems for synchronizing the operation of various medical equipment and fitness devices to a user or patient cardiac cycle, and in particular to synchronizing ECG and PPG systems to the cardiac cycle.
  • a wide variety of medical equipment and fitness devices either gather information or perform operations that are timed to the cardiac cycle of a user or patient.
  • simple fitness tracker watches and wearable bands are common devices that are used to detect a user's heart rate.
  • the grippable handles of exercise bicycles have also been fitted with sensors that can determine the user's heart rate.
  • the majority of these fitness tracking devices monitor a single biologic parameter (e.g. heart rate from one ECG lead). With such monitoring, signal delays, even significant ones, do not change the fitness tracker output. Obtaining more insight into the underlying biologic status and how it relates to optimal function requires coordinating input from different modalities in different locations on the body simultaneously. Coordinating input from multiple modalities at multiple locations requires a level of accuracy that a single device utilizing a single modality does not have. Signal delays that may be tolerable in the latter situation may be problematic with multiple modalities and/or locations on the body. This is especially true with inexpensive devices where cost considerations may not have placed a premium on minimizing signal processing delays.
  • a single biologic parameter e.g. heart rate from one ECG lead
  • All monitoring devices will have a delay between event detection and event notification, due to the internal circuitry of these devices.
  • a fitness tracker may sense a heart contraction (and signal that it has occurred) a few micro-seconds after the heart contraction has actually occurred. If the only task the monitor does is measure the heart rate, that rate will not be changed by a processing delay, so long as this delay applies to all beats. Since this signal delay tends to be the same length of time after each detected heartbeat, the heart rate can be accurately determined—but only because the same signal delay occurs every time after a heart beat has been detected.
  • PWTT Pulse Wave Transit Time
  • PWV Pulse Wave Velocity
  • obtaining a PWTT measurement requires an expensive and/or bulky ECG system detecting the QRS signal and a coordinated PPG (photoplethysmography) device at a patient's fingertip measuring the change in absorption of light projected at the tissue.
  • PPG photoplethysmography
  • the ECG signaling system detecting cardiac activity operates independently of the target PPG device, and has a delay between cardiac events and signaling of such events that the device collecting the PPG device is not aware of or cannot calibrate, then one cannot accurately calculate the PWTT.
  • This device which can collect data from the signaling device and compare the time collection against its own clock and data collection, can then assess the delay inherent in the original signaling device.
  • This calibration device can then transmit this delay information to the target device so that the target device, which is also receiving the signal from the signaling device, can accurately time the cardiac event against its own data collection (e.g. PPG data).
  • signal delays are caused by “machine” delays (i.e.: signal processing delays caused by and within the system hardware itself), or “transmission” delays (i.e.: signal delays caused by the medium through which the signal is carried) is immaterial from a calculation point of view, so long as they are characterized and consistent. For example, signals travel faster between devices that are wired together, whereas signals appear to travel slower between wireless devices due to the software processing needed at both ends. Moreover, signals also can travel slower when passing through tissues than when passing wirelessly through the air. In the case where some of the medical or fitness devices are wired together, and some are in wireless communication, the various delays can become rather problematic.
  • the present invention provides a system for synchronizing a target device to a cardiac cycle, comprising: (a) a target device that performs an operation that is to be timed to a cardiac cycle; (b) a signaling device that emits a signal indicating the occurrence of a cardiac contraction; and (c) a calibration device that determines the timing of the cardiac cycle.
  • the calibration device receives the signal from the signaling device and calculates a time offset between the timing of the signal from the signaling device and the timing of the cardiac cycle as determined by the calibration device. The calibration device then provides the time offset to the target device, thereby enabling synchronization of the target device to the cardiac cycle.
  • the time offset can be used either in target device “sensing” scenarios where the time offset provided to the target device comprises an adjustment of the times reported by the target device sensing specific physiological features of the cardiac cycle. In other preferred aspects, the time offset can be used in “performing an application” scenarios where the time offset provided to the target device comprises an adjustment of the times at which the target device performs actions based on specific physiological features of the cardiac cycle.
  • the time offset provided to the target device is used to perform an adjustment to the output of an internal clock in the target device.
  • the signaling device may emit a signal having a fixed consistent time relationship to an actual heart contraction.
  • the signal may not be specific as to cardiac cycle phase.
  • the signal emitted by the signaling device may identify those points in time corresponding specifically to heart contraction or the signal may correspond to other recurring points in time in the cardiac cycle that are not times of heart contraction.
  • the target device may be any one of: a PPG system; a cardiac/blood property monitoring device; a drug delivery device; a fluid sampling device; a fluid measuring device; a robotic surgery device; an imaging device; or a pacemaker.
  • the signaling device may be any one of: a heart rate measuring device, an ECG system, an imaging device, including but not limited to a fluoroscope, video-camera, MRI or CT machine, an acoustic device, including but not limited to a stethoscope, or a physical sensing device capable of determining a heart contraction, including but not limited to a chest belt strap device.
  • a heart rate measuring device an ECG system
  • an imaging device including but not limited to a fluoroscope, video-camera, MRI or CT machine
  • an acoustic device including but not limited to a stethoscope, or a physical sensing device capable of determining a heart contraction, including but not limited to a chest belt strap device.
  • any number of additional (same or different types of) target devices can be added to the present system, with each one being accurately calibrated to the cardiac cycle using the above described methods.
  • the first and second target devices are both PPG systems configured to be positioned on different anatomical locations on a patient (for example, on opposite left and right limbs of a patient).
  • the first target device is a PPG system
  • the signaling device is a simple ECG system (such as an ECG monitoring wrist watch or band)
  • the calibration device is a different (i.e.: second) ECG system.
  • the signaling device could also be a simple heart rate monitor such as a chest band monitor.
  • the calibration ECG system is in communication with the target PPG system and the signaling system is also in communication with the target PPG system.
  • the time offset is the difference in time of the detection of a QRS signal between each of the calibration ECG system and the signaling system.
  • the calibration ECG device is removed after the time offset has been provided to the target device. Since the calibration ECG system can be more expensive than a signaling ECG system, this approach has the advantage of cost savings since the same expensive ECG calibration system can then be used to synchronize multiple, cheaper ECG (or non-ECG) signaling systems.
  • the leads of the signaling ECG system may be disposed in opposite handlebars of an exercise machine or in opposite sides or ends of a hand-held device or hand-held device cover. Other possibilities are also contemplated, all keeping within the scope of the present invention.
  • the leads of the calibration device may be disposed in a single patch or a pair of patches worn on a person's skin.
  • the leads of the calibration device can be disposed in an article of clothing or wearable garment including, but not limited to: a glove, a hat, a headband, a shirt/blouse, a pair of pants, a belt or strap, ear buds or other headphones, a shoe, a sock, outerwear, underwear, a backpack, a handbag, a bag.
  • the first target device comprises a Doppler system
  • the signaling device comprises an MRI system
  • the calibration device comprises an ECG system.
  • the calibration device is in communication with the first target device, and the signaling device is also in communication with the first target device.
  • the signaling device may be an MRI in Cine mode or an Echocardiogram system
  • the first target device may be a PPG system.
  • a system for synchronizing a target device to a cardiac cycle, comprising: (a) a target device that performs an operation that is to be timed to a cardiac cycle; and (b) a combined calibration-and-signaling device that determines the timing of the cardiac cycle.
  • the calibration-and-signaling device calculates a time offset between the timing of the occurrence of the cardiac contraction and the timing of the cardiac cycle as determined by the calibration-and-signaling device, and the calibration-and-signaling device provides the time offset to the target device thereby enabling synchronization of the first target device to the cardiac cycle.
  • the signal that is synchronized to the cardiac cycle is a composite PPG signal that has been generated by comparing PPG signal lengths to one another, wherein the PPG signal lengths are segmented on the basis of repeating features in the cardiac cycle.
  • the composite PPG signal that is synchronized to the cardiac cycle may be generated by measuring the PPG signal over a plurality of cardiac cycles, and then segmenting the signal into lengths corresponding to cardiac cycle features and then comparing the signal segments to one another. It is to be understood that a wide variety of approaches can be used for comparing these signal segments to one another to generate the representative composite signal, all keeping within the scope of the present invention.
  • signals may be segmented and then mathematically combined (e.g.: averaged, summed, combined through weighted averages, or combined through other mathematical approaches, etc.) over the full R-to-R length of the cardiac cycle signals each having a length from one R wave to the next R wave.
  • the signals may be segmented into lengths corresponding to specific portions of the full cardiac cycle, and then mathematically combined, or otherwise compared to one another.
  • the signal segments are compared to one another or mathematically combined after first being placed into categories or bins (corresponding to different pulse/cardiac cycle durations).
  • the signals in a category are compared against one another or mathematically combined to generate a composite waveform for that category.
  • segments may be compared against prior segments to look for similarities. Systems may also be employed to reject signal outliers prior to comparing these segments to one another, all keeping within the scope of the present invention.
  • An advantage of using a composite PPG signal is that (as will be further explained) motion artifacts, noise and other irregularities in a measured PPG signal can be significantly reduced or even eliminated, thereby providing a signal that more accurately parallels actual physiological functions.
  • An advantage of using a composite PPG signal in the present synchronization system is that by first having the PPG and ECG systems' signals synchronized to one another, the generation of the composite PPG wave is very accurate, and thus provides an excellent representation of cardiac functioning.
  • FIG. 1 is a schematic illustration of the present system.
  • FIG. 2 is an illustration of the signal readings of the various components of a preferred embodiment of the present system.
  • FIG. 3A is an illustration of a preferred embodiment of the present system using a removable calibration device (prior to removal of the calibration device).
  • FIG. 3B is an illustration corresponding to FIG. 3B , but with the calibration device removed.
  • FIG. 4A is an illustration of an exemplary calibration ECG system positioned on a patient's chest, with an exemplary signaling ECG system and target PPG system disposed in a band around the patient's arm.
  • FIG. 4B is a sectional view through the patient corresponding to FIG. 4A .
  • FIG. 5A is a top perspective view of an exemplary signaling and target device disposed in an adhesive chest patch.
  • FIG. 5B is a bottom perspective view of the exemplary signaling and targeting device of FIG. 5A .
  • FIG. 5C illustrates exemplary signaling and targeting devices disposed in a chest strap worn by the patient.
  • FIG. 6A is an exemplary handheld signaling and target device positioned on a patient's chest.
  • FIG. 6B is a sectional view through the patient corresponding to FIG. 6A .
  • FIG. 7A is a top perspective view of an exemplary signaling and targeting device that is held in a patient's hands.
  • FIG. 7B is a bottom perspective view of the signaling device of FIG. 7A .
  • FIG. 8A illustrates ECG and PPG signals measured over a plurality of cardiac cycles.
  • FIG. 8B illustrates the generation of a PPG composite signal from averaged PPG signal segments corresponding to successive cardiac cycles.
  • FIG. 9 is a first side-by-side comparison of ECG and PPG signals showing steps in an alternate method of generating a PPG composite wave.
  • FIG. 10 is a second side-by-side comparison of ECG and PPG signals showing steps in an alternate method of generating a PPG composite wave.
  • FIG. 1 is a schematic illustration of the present system 10 for synchronizing one or more target devices T 1 , T 2 . . . Tn to a cardiac cycle.
  • System 10 comprises: (a) at least one target device T 1 (T 2 . . . to Tn) that performs an operation that is to be timed to a cardiac cycle; (b) a signaling device S that emits a signal indicating the occurrence of a cardiac contraction; and (c) a calibration device C that determines the timing of the cardiac cycle.
  • T 1 T 2 . . . to Tn
  • the calibration device C receives a signal from signaling device S and then calibration device C calculates a time offset TO between the timing of the heart contraction as determined by the signaling device S and the timing of the heart contraction in the cardiac cycle as determined by the calibration device C.
  • the calibration device C provides the time offset TO to target device T 1 thereby enabling synchronization of target device T 1 to the cardiac cycle.
  • the first target device T 1 may each be one of the following systems or devices: a PPG (photoplethysmography) system; any cardiac/blood property monitoring device; a drug delivery device; a fluid sampling device; a fluid measuring device; a robotic surgery device; an imaging device; or a pacemaker.
  • a PPG photoplethysmography
  • the present target device T 1 to Tn are not limited to only to these specific devices. It is also to be understood that the present system encompasses embodiments with only one target device T 1 , and embodiments with any plurality of target devices T 1 to Tn.
  • the signaling device S may be one of the following systems and devices: a heart rate measuring device, an ECG system, an imaging device, including but not limited to a fluoroscope, video-camera, MRI or CT machine, an acoustic device, including but not limited to a stethoscope, or a physical sensing device capable of determining a heart contraction, including but not limited to a chest belt strap device.
  • a heart rate measuring device including but not limited to a fluoroscope, video-camera, MRI or CT machine
  • an acoustic device including but not limited to a stethoscope
  • a physical sensing device capable of determining a heart contraction, including but not limited to a chest belt strap device.
  • a plurality of target devices T 1 to Tn each perform an operation that is to be accurately timed to the cardiac cycle, and the calibration device C provides the time offset TO to each of these target devices, thereby enabling synchronization of each of the plurality of target devices to the cardiac cycle.
  • the signaling device S is a first ECG system
  • the calibration device is a second ECG system
  • the target device is a PPG system.
  • the signaling device S can be a simple, inexpensive ECG system such as a system in a wrist watch or band, or in a chest band; whereas the calibration ECG system C can be a more expensive and more accurate ECG system).
  • the signaling device S is an MRI system
  • the calibration device is an ECG system
  • the target device is a Doppler system.
  • the signaling device S may instead be an MRI in Cine mode or an Echocardiogram system
  • the target device may instead be a PPG system.
  • the calibration device C is in communication with the target device T 1
  • the signaling device S is also in communication with target device T 1 .
  • a system for synchronizing a first target device to a cardiac cycle comprising: (a) a target device(s) that performs an operation that is timed to a cardiac cycle; and (b) a calibration-and-signaling device that determines the timing of the cardiac cycle.
  • the calibration-and-signaling device calculates a time offset between the timing of the occurrence of the cardiac contraction and the timing of the cardiac cycle as determined by the calibration-and-signaling device, and the calibration-and-signaling device provides the time offset to the first target device thereby enabling synchronization of the first target device to the cardiac cycle.
  • FIG. 2 is an illustration of the signal readings of the various components of one preferred embodiment of the present system, as provided by the various components of an exemplary embodiment of the present system (as further illustrated in FIGS. 3A and 3B ), as follows.
  • the signal emitted by signaling device S is a repeating waveform generally corresponding to the user's cardiac cycle, showing the times at which the heart's QRS wave is detected.
  • the signals detected by calibration device C is also a repeating waveform generally corresponding to the user's cardiac cycle, also showing the times at which the heart's QRS wave is detected.
  • the signaling and calibration devices S and C do not detect the heart's QRS wave at exactly the same times. This is due to the fact that the signaling device S may be a cheaper, simpler device having an inherent signal time delay (as compared to the more sophisticated calibration device C).
  • the delay in the signal from signaling device S results both from the combination of the delay in the circuit itself (i.e.: the time spent for signaling device S to read and transmit its signal) and the delay in the signal traveling across the body (for example, the signal traveling from a different body location from that of calibration system C).
  • the time offset TO is the difference in time of the detection of a QRS signal between each of the calibration and signaling systems C and S.
  • the calibration system C senses the cardiac cycle, and knowing its own delay properties it determines the time offset TO that is then provided to target device T 1 so that the target device T 1 can synchronize to the cardiac cycle.
  • the time offset TO provided to the first target device T 1 comprises an adjustment to be made to the internal clock output in target device T 1 .
  • the time offset TO provided to the first target device T 1 may either comprise an adjustment of the times reported by the first target device when sensing specific physiological features of the cardiac cycle, or the times of performing actions based on specific physiological features of the cardiac cycle.
  • the time offset TO provided by calibration system C will be used to permit target device T 1 to accurately measure a patient or user's PWTT (so as to generate various pulse metrics). It is to be understood, however, that many other applications of the present system are also contemplated within the scope of the present invention.
  • the signaling device S emits a signal that either: has a fixed consistent time relationship to an actual heart contraction, or is not specific as to cardiac cycle phase.
  • the signaling device may emit a simple “beep” only at points in time when it senses a heart contraction, or it may emit a continuous signal that corresponds to other known points in a cardiac cycle that are not times of heart contraction.
  • the signaling device emits a continuous ECG signal.
  • the signal processing delays i.e.: delays within the circuitry itself
  • delays caused by individual patient physiology i.e.: the speed of travel of electrical signals through the patient's body
  • the speed at which signals travel through the patient's body can vary over time as the patient's health changes.
  • different types of signaling devices S will have different delays. All of these delays will be consistent for one patient with one set of devices at one time. The present system can effectively deal with all these irregularities since it relies upon a more accurate calibration ECG system C to determine the exact timing of the cardiac cycle.
  • the first target device T 1 comprises a first PPG system
  • the second target device T 2 comprises a second PPG system
  • the signaling device S comprises a first (simple, less accurate) ECG system
  • the calibration C device comprises a second (more accurate) ECG system.
  • the calibration device C is in communication with the target devices T 1 and T 2
  • the signaling device S is also in communication with the target devices T 1 and T 2 .
  • the first and second target devices T 1 , T 2 are both PPG systems configured to be positioned on different anatomical locations on a patient, for example, the opposite lateral limbs of a patient (e.g.: fingers on the patient's left and right hands).
  • the objective of the system illustrated in FIGS. 3A and 3B is to easily calculate the patient's simultaneous PWTT to each of the patient's opposite limbs. (It is to be understood that target device T 2 can be removed from FIGS. 3A and 3B so that the system instead functions only to calculate the PWTT to one limb at a time).
  • a user can keep track of their personal fitness by monitoring the pulse metrics obtainable once a stable/reproducible PWTT is established for any given scenario.
  • pulse metrics shape/slope/peaks/rolloff, etc.
  • Such pulse metrics provide insight into the cardiovascular status of the individual, such as whether peripheral arterial resistance is high or low.
  • PWTT is determined by measuring the time difference between the onset of the heart contraction (i.e.: the accurate time detection of the QRS signal as measured by the calibration ECG system C) and the time at which the peak arterial pulse reaches a desired location on the patient's body (i.e.: the accurate time detection of the maximum and minimum of the signal reading taken by a PPG device T 1 at a patient's finger tips).
  • a PPG (photoplethysmography) system measures changes in the light reflected from or transmitted through the illuminated skin. The blood pulse wave distends the arterioles as it passes through them. Therefore, the arrival time of each pulse in the cardiac cycle can be read as a maximum (the onset of the arterial pulse) and a minimum (at the peak of the pulse) in the signal from the PPG's light sensor.
  • ECG and PPG systems typically each have their own dedicated internal clocks which measure time separately.
  • synchronizing ECG and PPG time signals has proven to be especially problematic because of the effect of very small (microsecond to millisecond) differences in clock timing. These problems occur even with signal time differences even being a few microseconds or milliseconds apart.
  • problems also occur with simple ECG signaling systems due to the high noise to signal ratio and potential for outside interference. Measuring a patient's ECG with a simple fitness tracker signaling device is also problematic due to intermittent connections inherent in poor skin connection. Motion of the patient also degrades the accuracy when taking an ECG reading with a simple device.
  • the most accurate ECG readings are taken when the ECG leads are positioned far apart on the patient.
  • the most accurate ECG measurement approaches tend to be the ones that are most intrusive, or require the patient to remain motionless in a hospital or doctor's office. It would instead be desirable to provide an accurate, synchronized ECG system that can be used while moving or exercising.
  • the present solution addresses these concerns and enables a person to simply, cheaply (and accurately) measure their own arterial pulse metrics in the convenience of their own home or place of exercise.
  • Prior art solutions instead often relied on a (3 rd ) master clock to send time signals to each of the internal clocks of the ECG and PPG monitoring systems.
  • Objectives of the present system are to achieve time synchronization: (a) without relying on a 3rd master clock, (b) without relying on a 2nd separate clock timing in one of the ECG or PPG systems, and (c) without having to determine which of two clocks is “more correct”, and then make adjustments or apply some form of averages to these multiple clocks.
  • Another objective of the present system is the removal of the wired connection between the ECG and PPG monitoring systems. As such, the present system can conveniently be used when exercising.
  • Another objective of the present system is to employ the best placement for each of the ECG and PPG sensors on the body. With the present system, optimal placement of each of the ECG and PPG sensors on the body can be achieved, with the present system providing the required calibration.
  • the PWTT TIME is the time from the calibration system C detecting the QRS wave to the time the target PPG device T 1 (or T 2 ) detects maximum arterial blood volume. This is represented on FIG. 2 as the signal from T 1 . (The signal from tracking device T 2 is omitted from FIG. 2 for clarity).
  • the (cheaper, simpler) signaling device S will detect the QRS wave at a slightly delayed time as compared to the (more expensive and more accurate) calibration device C. Therefore, by adjusting targeting device T 1 's internal clock back by the time offset TO, a correct PWTT TIME can be determined. Stated another way, the difference in time between the signals from devices S and C will be provided to target device T 1 enabling it to synchronize signaling to the cardiac cycle. Stated yet another way, after system calibration, in essence the signaling ECG system S shares the same internal clock of the calibration ECG system C.
  • An advantage of the present system is that it is only necessary to determine the timing of the QRS wave with each one of the S and C devices. Thus, it is only necessary to determine when the maximum PPG (and ECG) signals occurs. Importantly, it is not necessary to exactly determine the exact level of these signals. Therefore, an advantage of the present system is that different ECG and PPG systems can be used (with the present system compensating for differences i.e.: system calculation delays) between different manufacturers.
  • the calibration ECG device C can be removed after the time offset TO has been provided to the first PPG target device T 1 (and optionally to a second target device T 2 ).
  • a single expensive calibration system C can be used to calibrate multiple target devices T 1 , T 2 , etc. This allows cheaper, fitness-monitoring watches and bands to be synchronized to a patient's cardiac cycle such that they can be used to accurately measure a fitness enthusiast's pulse metrics (after calculating PWTT).
  • Periodic recalibration of the target device(s) can be done to the PPG device(s) T 1 (and T 2 ).
  • An important advantage of calibrating a fitness-monitoring watch or band (i.e.: signaling device S) to a patient's cardiac cycle is that the signaling device S can be a small, lightweight, inconspicuous and comfortable device that can be worn while exercising. As such, a more expensive, bulky, yet highly accurate ECG system (i.e.: calibration device C) need not be required during exercise or continued use.
  • the leads of the signaling ECG system S can be disposed in opposite handlebars of an exercise machine.
  • the leads of the signaling or calibration ECG devices can optionally be disposed in opposite sides or ends of a hand-held device (such as a smartphone or stethoscope).
  • FIGS. 4A and 4B illustrate an exemplary ECG calibration system for use with a signaling PPG system and target ECG system.
  • an existing telemetry system 90 functions as the calibration system (i.e.: telemetry system 90 corresponds to system C in FIG. 3A ).
  • An arm strap 80 houses both the target and signaling systems (corresponding to illustrated T and S systems in FIGS. 3A and 3B ).
  • Arm strap system 80 wraps around the patient's arm (or leg) and includes a right electrode 54 and a PPG sensor 60 .
  • the left electrode 52 extends across the patient's chest to measure electrical signals on the left side of the patient's heart. In the embodiment shown in FIG.
  • the present system simply piggy-back connects left chest electrode 52 on an existing telemetry system electrode 91 from telemetry system 90 .
  • a stackable rivet-type electrode snap may be provided such that arm electrode 52 can quickly and easily be attached to the opposite chest electrode 91 .
  • the electrodes may be wet or dry electrodes. An advantage of using wet electrodes is that they tend to provide a stronger, more stable signal. It is to be understood that the present system does not require telemetry system 90 to be used on the patient at the same time as the present system. As such, telemetry system 90 (and its associated electrode 91 ) can be removed from the patient after the calibration has been performed (as illustrated in FIG. 3B where C has been removed).
  • FIGS. 5A and 5B illustrate an exemplary adhesive patch system 150 housing both signaling and target devices (corresponding to systems S and T in FIGS. 3A and 3B ), as follows.
  • Integrated patch system 150 can be used to measure a person's PWTT/pulse waveform.
  • Patch 150 may preferably comprise a left electrode 152 and a right electrode 154 for measuring ECG readings across the patient's heart.
  • a PPG sensor 160 is also provided.
  • Electrode 154 may also optionally be a “snap” electrode that simply piggy-back connects left chest electrode 152 on an existing telemetry system electrode (i.e.: electrode 91 from telemetry system 90 in FIG. 4A ).
  • FIG. 5C illustrates a similar chest strap device 50 housing both signaling and target devices (again corresponding to systems S and T in FIGS. 3A and 3B ), as follows.
  • Chest belt or strap mounted device 50 can be used to measure a person's PWTT/pulse waveform.
  • Strap device 50 may preferably comprise a strap body 51 with a left electrode 52 and a right electrode 54 for measuring ECG readings across the patient's heart.
  • the PPG sensor 60 is disposed on the patient-facing side of strap body 51 .
  • FIG. 5C illustrates the positioning of the signaling device along the lines of the adhesive patch system of FIGS. 5A and 5B , but when the device is instead positioned within a chest strap worn by the patient.
  • FIGS. 6A and 6B illustrate yet another exemplary device housing both signaling and target devices (corresponding to systems S and T in FIGS. 3A and 3B ), as follows.
  • Device 10 is a chest or side mounted device for measuring pulse waveforms.
  • Device 10 comprises a housing (that is preferably shaped to be hand-held, as shown), having a first (left chest) electrode 12 and a second (right chest) electrode 14 thereon.
  • An ECG system (corresponding to signaling system S in FIGS. 3A and 3B ) is disposed within the housing of device 10 and is in electrical communication with electrodes 12 and 14 .
  • electrodes 12 and 14 are thus positioned across the patient's heart to take ECG readings on the patient.
  • At least one (but preferably a plurality) of PPG sensor(s) 20 are also disposed on the housing of device 10 .
  • Logic for measuring the PPG signal from sensor 20 is disposed within the housing of device 10 .
  • control and communication systems are also disposed within the housing of device 10 .
  • An optional right electrode lead can be plugged into the housing of device 10 such that the patient's ECG can be measured across the patient's torso (when the patient is in a prone position).
  • FIGS. 7A and 7B illustrate an exemplary handheld signaling and targeting device that is held in a patient's hands.
  • Device 200 has a pair of electrode handles 202 onto which a user grasps. The user simply holds electrode handles 202 and then uses their thumb to push start button 203 . The user then immediately moves their thumb or finger to be positioned against PPG sensor 204 . Holding onto electrode handles 202 completes a circuit across the heart allowing the ECG system in device 200 to measure ECG waveforms.
  • the PPG sensor 204 allows the PPG system in device 200 to measure PPG waveforms.
  • the ECG system in device 200 corresponds to the signaling system S and the PPG system in device 200 corresponds to the target system T in FIGS. 3A and 3B .
  • FIG. 7B shows a bottom screen that optionally displays a Pulse Wave Transit Time.
  • the present calibration system preferably uses a “composite” PPG signal that is synchronized to the cardiac cycle.
  • the composite PPG signal is preferably generated by comparing various lengths of PPG signal segments to one another, and these signal lengths are preferably segmented on the basis of repeating features in the cardiac cycle.
  • the generation of such a composite signal PPG waveform mitigates the current problems of signal noise and motion artifacts when measuring a patient's PPG signals, as follows.
  • the present system instead provides is a system for quickly producing reliable PPG signals such that pulse metrics can be determined accurately (and preferably without having to restrain the motion of the patient, while also not using high or low pass filtering which can remove important data from the signal).
  • this preferred system provides data from patients in motion that is consistently usable for analysis by removing large amounts of noise from motion and other artifacts.
  • the present invention provides systems for removing motion and ambient variability from PPG sensor data to improve discovery of the underlying unfiltered PPG waveform.
  • the present system's novel computerized logic system includes various optional circuitry and logic systems that remove or compensate for the effects of noise in the PPG signal, as follows.
  • an ECG signal 200 is measured over a plurality of cardiac cycles. Specifically, the onset of the heart's R-wave of the QRS complex occurs repeatedly at points 202 .
  • the PPG system measures the PPG signal 300 's strength over the same time period (i.e.: over a plurality of cardiac cycles).
  • the PPG signal is then segmented in lengths corresponding to the length of the cardiac cycle. For example, a first segment 300 1 will be measured over the first cardiac cycle (i.e. between times to and t 1 ), a second segment 300 2 will be measured over the second cardiac cycle (i.e.
  • segments 300 1 , 300 2 and 300 3 can be averaged to produce a representative or “composite” signal segment 300 C. It is to be understood that the use of three segments in FIGS. 8A and 8B is merely exemplary. For example, a greater number of PPG signal segments 300 n may be used to generate the representative or composite signal segment 300 C.
  • the present system advantageously removes signal errors by taking a long PPG signal reading 300 (i.e.: lasting greater than several cardiac cycles), and then dividing the PPG signal into segments corresponding to the timing of the cardiac cycles.
  • the present PPG signal reading 300 is parsed or segmented based upon the timing of the cardiac QRS rhythm.
  • analysis of the exact shape of the waveform can be used to calculate various pulse wave metrics or observe other cardiac system features.
  • generation of the composite PPG signal is performed by selecting PPG signal waveforms of similar R-to-R intervals of the pulse/cardiac cycle prior to the pulse/cardiac cycle in question.
  • characteristics such as peak height, peak width, slope and duration can all contribute to a calculation that is accurately representative of that particular wave form.
  • FIG. 9 is a first side-by-side comparison of ECG and PPG signals showing steps in an alternate method of generating a PPG composite wave.
  • an ECG signal 400 is taken over five pulses/cardiac cycles (labelled pulses A, B, C, D and E).
  • a PPG signal 500 is also taken over the same five pulses/ cardiac cycles (A, B, C, D and E).
  • each of the five pulse lengths are not of exactly equal duration (which is to be expected as an individual's heart rate will vary over time).
  • the PPG signal will first be segmented and put into categories or “bins” representing segments of approximately equal lengths.
  • all of the “short” segments can be grouped, categorized and analyzed together, all of the “intermediate length” segments can be categorized and analyzed together, and all of the “long duration” segments can be categorized and analyzed together.
  • separate composite waves can be generated for each of the short, intermediate and long categories of waveform segments. This is particularly useful in that some cardiac conditions or features may best be analyzed for an intermediate length pulse, whereas other cardiac conditions or features may best be analyzed for a short or long duration pulses. In fact, further insights may be gained by comparing composite PPG waveform segments from one category with another.
  • the pulses are sorted into categories based on the length of the previously measured pulse (and not the length of the current pulse being measured).
  • the advantage of this novel approach is that it categorizes waveforms on the basis of similar ventricular fillings. Specifically, the filling stage of the heart in one cardiac cycle will correspond to the squeezing or emptying stage of the heart in the next cardiac cycle. Stated another way, the pre-contraction ventricular filling state will depend upon the time available to fill after the last contraction. Ventricular function will therefore vary beat to beat depending upon the variability of the pulse length.
  • R-to-R pulses are preferably compared in pairs, with the second pulse being categorized on the basis of the length of the first pulse, as follows.
  • Pulses B and E are categorized on the basis of their immediately previous pulses (i.e.: Pulse A and Pulse D). Since Pulses A and D were intermediate duration pulses; Pulses B and E are therefore placed together in the intermediate length category (even though Pulses B and E have considerably different lengths).
  • FIG. 10 shows a longer series of pulses A to I.
  • the prior R-to-R categorization (in which two successive pulses are analyzed together) proceeds as follows. Pulses B and C are analyzed together as a first “ 2 beat complex”. C is placed into a category corresponding to the length of B. Next, pulses C and D are analyzed together as a second “2 beat complex”. D is placed into a category corresponding to the length of C. Next, pulses D and E are analyzed together and E is placed into a category corresponding to the length of D. Next, pulses E and F are analyzed together and F is placed into a category corresponding to the length of E, etc.
  • the categorizations of waveform segments illustrated in FIGS. 9 and 10 can also be re-categorized and then re-analyzed over a longer period of time.
  • the various categories into which the segments are placed can also be changed to perform additional analysis. For example, it may make sense to record ECG signal 400 and PPG signal 500 over several hundred cardiac cycles. Once all this data has been recorded and the waveforms segmented into their R-to-R segments (or otherwise segmented based on repeating identifiable cardiac features), then the present system can go back and place the segments into different categories.
  • these segments can be placed into three categories (short, intermediate and long), or more categories (e.g.: very short, short, short-intermediate, standard-intermediate, long-intermediate, long and very long).
  • categories e.g.: very short, short, short-intermediate, standard-intermediate, long-intermediate, long and very long.
  • the present invention encompasses all forms of composite wave generation, and all forms of segmenting pulse waveforms to group the segments into self-similar groups, categories or bins of different time durations.
  • analysis of one category e.g.: the intermediate duration segments
  • analysis of another category e.g.: the long duration segments
  • the advantage of the present system is that it provides a novel platform to categorize the waveform segments based on their relationships to the one another in general, and to the segment that immediately precedes it in particular.

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BR112022020839A BR112022020839A2 (pt) 2019-12-30 2021-04-13 Sistema e método de medição de saturação venosa de oxigênio com uso da média de pulso inteligente com sensores de ecg e ppg integrados
EP21788382.6A EP4135573A4 (en) 2019-12-30 2021-04-13 SYSTEM AND METHOD FOR MEASURING VENOUS OXYGEN SATURATION WITH INTELLIGENT PULSE AVERAGEMENT WITH INTEGRATED ECG AND PPG SENSORS
US17/229,741 US11801016B2 (en) 2019-12-30 2021-04-13 System and method of assessing intra-arterial fluid volume using intelligent pulse averaging with integrated EKG and PPG sensors
EP21788309.9A EP4135572A4 (en) 2019-12-30 2021-04-13 SYSTEM AND METHOD FOR INTRA-ARTERIAL FLUID VOLUME ASSESSMENT USING SMART PULSE AVERAGING WITH INTEGRATED EKG AND PPG SENSORS
CA3177642A CA3177642A1 (en) 2020-04-14 2021-04-13 System and method of assessing intra-arterial fluid volume using intelligent pulse averaging with integrated ekg and ppg sensors
MX2022012886A MX2022012886A (es) 2019-12-30 2021-04-13 Sistema y metodo de medicion de la saturacion de oxigeno venoso mediante el uso de promedio de pulso inteligente con sensores de ecg y fpg integrados.
MX2022012799A MX2022012799A (es) 2019-12-30 2021-04-13 Sistema y metodo de evaluacion del volumen de liquido intraarterial mediante el promediado inteligente del pulso con sensores integrados de ecg y ppg.
JP2022562720A JP7345681B2 (ja) 2019-12-30 2021-04-13 統合されたｅｋｇ及びｐｐｇセンサを用いたインテリジェントパルス平均化を使用して静脈酸素飽和度を測定するシステム及び方法
CA3177643A CA3177643A1 (en) 2020-04-14 2021-04-13 System and method of measuring venous oxygen saturation using intelligent pulse averaging with integrated ekg and ppg sensors
KR1020227035775A KR102595127B1 (ko) 2019-12-30 2021-04-13 통합 ekg 및 ppg 센서와 함께 지능형 펄스 평균을 사용하여 정맥 산소 포화도를 측정하는 시스템 및 방법
AU2021255871A AU2021255871B2 (en) 2019-12-30 2021-04-13 System and method of measuring venous oxygen saturation using intelligent pulse averaging with integrated EKG and PPG sensors
BR112022020829A BR112022020829A2 (pt) 2019-12-30 2021-04-13 Sistema e método de avaliação de volume de fluido intra-arterial usando a média de pulso inteligente com sensores de ecg e ppg integrados
KR1020227035787A KR102595937B1 (ko) 2019-12-30 2021-04-13 통합된 ekg 및 ppg 센서와 함께 지능형 펄스 평균화를 사용하여 동맥내 체액 체적을 평가하는 시스템 및 방법
US17/229,759 US11896405B2 (en) 2019-12-30 2021-04-13 System and method of measuring venous oxygen saturation using intelligent pulse averaging with integrated EKG and PPG sensors
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KR1020237036839A KR20230152820A (ko) 2019-12-30 2021-04-13 통합된 ekg 및 ppg 센서와 함께 지능형 펄스 평균화를 사용하여 동맥내 체액 체적을 평가하는 시스템 및 방법
JP2022562719A JP7346753B2 (ja) 2019-12-30 2021-04-13 統合されたｅｋｇ及びｐｐｇセンサを用いたインテリジェントパルス平均化を使用して動脈内液量を評価するシステム及び方法
PCT/US2021/027158 WO2021211634A1 (en) 2020-04-14 2021-04-13 System and method of assessing intra-arterial fluid volume using intelligent pulse averaging with integrated ekg and ppg sensors
KR1020237036508A KR20230151085A (ko) 2019-12-30 2021-04-13 통합 ekg 및 ppg 센서와 함께 지능형 펄스 평균을 사용하여 정맥 산소 포화도를 측정하는 시스템 및 방법
AU2021256968A AU2021256968B2 (en) 2019-12-30 2021-04-13 System and method of assessing intra-arterial fluid volume using intelligent pulse averaging with integrated EKG and PPG sensors
AU2023202053A AU2023202053A1 (en) 2019-12-30 2023-04-04 System and method of measuring venous oxygen saturation using intelligent pulse averaging with integrated ekg and ppg sensors
AU2023202274A AU2023202274A1 (en) 2019-12-30 2023-04-13 System and method of assessing intra-arterial fluid volume using intelligent pulse averaging with integrated ekg and ppg sensors
JP2023142748A JP2023159456A (ja) 2019-12-30 2023-09-04 統合されたｅｋｇ及びｐｐｇセンサを用いたインテリジェントパルス平均化を使用して静脈酸素飽和度を測定するシステム及び方法
JP2023143448A JP2023164937A (ja) 2019-12-30 2023-09-05 統合されたｅｋｇ及びｐｐｇセンサを用いたインテリジェントパルス平均化を使用して動脈内液量を評価するシステム及び方法
US18/385,294 US20240130692A1 (en) 2019-12-30 2023-10-29 System and method of assessing intra-arterial fluid volume using intelligent pulse averaging with integrated ekg and ppg sensors
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