Intersection cross-cut: patch ∩ algo-arrhythmia-classification

Axes: form_factor × algorithms

5 corpus entries disclose both tags.

Earliest disclosure: 1961-04-21

These entries are the direct inputs to OBVIOUSNESS_TEMPLATE.md. Any patent claim combining these two elements is anticipated or rendered obvious by the chain below.

Holter (1961) — continuous ambulatory electrocardiography (the Holter monitor) (1961-04-21)

  • id: holter-1961-ambulatory-ecg
  • corpus: academic
  • form factor: garment
  • creator: Norman J. Holter
  • disclosure: Holter NJ. ‘New method for heart studies: continuous electrocardiography of active subjects over long periods is now practical.’ Science 1961;134(3486):1214-1220.
  • ip status: public-domain
  • sensors: sensor-ecg
  • algorithms: algo-arrhythmia-classification
  • prior art notes: Establishes continuous, ambulatory, body-worn recording of the ECG over hours to days while the subject is active, for later analysis — the foundational ‘wearable continuous ECG monitor’. Any claim reciting ‘a body-worn device configured to continuously record an electrocardiographic signal of the wearer over an extended period for subsequent arrhythmia analysis’ reads on Holter 1961. Anchor for the ambulatory-ECG / ECG-patch cross-cut; [[zio-patch-irhythm-2009]] and Apple Watch’s ECG history both build on it.

Pantelopoulos & Bourbakis (2010) — survey on wearable sensor-based systems for health monitoring and prognosis (2010-01)

  • id: pantelopoulos-bourbakis-2010-wearable-health-survey
  • corpus: academic
  • form factor: other
  • creator: Alexandros Pantelopoulos / Nikolaos G. Bourbakis
  • disclosure: Pantelopoulos A, Bourbakis NG. ‘A survey on wearable sensor-based systems for health monitoring and prognosis.’ IEEE Transactions on Systems, Man, and Cybernetics, Part C (Applications and Reviews) 2010;40(1):1-12.
  • ip status: public-domain
  • sensors: sensor-ecg, sensor-ppg, sensor-spo2, sensor-accelerometer, sensor-skin-temperature, sensor-respiration-impedance
  • algorithms: algo-hr, algo-arrhythmia-classification, algo-spo2-estimation, algo-fall-detection, algo-activity-classification
  • prior art notes: Surveys, as of 2010, the architecture and components of wearable health-monitoring systems — sensors (ECG, PPG, SpO2, accelerometry, temperature, respiration), garment- and patch- and watch-based form factors, on-body processing, wireless body-area networking, and the analytics (arrhythmia, fall, activity, deterioration prediction). Prior art establishing that the general ‘multi-sensor wearable + body-area network + cloud analytics’ system architecture and its building blocks were collected and published by 2010 — useful against later claims to the bare system architecture. General anchor.

FDA 510(k) K113862 (~2011) — iRhythm Zio Patch, long-term single-lead adhesive ECG monitor (2011-12)

  • id: fda-k113862-irhythm-zio-patch-2011
  • corpus: regulatory
  • form factor: patch
  • creator: U.S. Food and Drug Administration (CDRH); submitter iRhythm Technologies, Inc.
  • disclosure: U.S. FDA, 510(k) Premarket Notification K113862 (iRhythm Technologies, Inc., ‘Zio Patch’) — record at accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113862; a single-use adhesive chest patch recording a single channel of ECG continuously for up to ~14 days for later analysis, cleared as substantially equivalent to predicate ambulatory-ECG (Holter-class) devices. (Followed by a chain of subsequent iRhythm 510(k)s — e.g. K143513, K163512, K181502 — refining the device, the algorithm/ZEUS software, and the Zio AT mobile-cardiac-telemetry variant.)
  • ip status: regulatory-filing
  • sensors: sensor-ecg
  • algorithms: algo-arrhythmia-classification, algo-afib-detection
  • prior art notes: A public, dated FDA record of a single-use adhesive chest patch that records one channel of ECG continuously for up to ~14 days for later arrhythmia analysis — the modern ‘ECG patch’ realization of ambulatory ECG ([[holter-1961-ambulatory-ecg]]). Establishes as of ~2011 the public availability of an adhesive long-wear single-lead ECG patch with downstream automated arrhythmia analysis; and, as a 510(k), it cites a predicate chain back to earlier ambulatory-ECG devices — that chain is itself prior art. Prior art for ECG-patch claims; product-side and regulatory anchor for the patch × ECG cross-cut. Cf. [[apple-watch-series4-ecg-2018]] (the wrist single-lead route).

VitalConnect VitalPatch (2016) — adhesive chest patch with single-lead ECG and multi-parameter monitoring (2016)

  • id: vitalconnect-vitalpatch-2016
  • corpus: private
  • form factor: patch
  • creator: VitalConnect, Inc.
  • disclosure: VitalConnect, Inc. ‘VitalPatch’ biosensor, FDA-cleared as a single-use adhesive chest patch with single-lead ECG, heart rate, heart-rate variability, respiratory rate, skin temperature, posture, activity, and fall detection, streamed wirelessly to a smartphone/relay; 7-day wear (later 14-day variants).
  • ip status: patented
  • sensors: sensor-ecg, sensor-accelerometer, sensor-skin-temperature
  • algorithms: algo-hr, algo-hrv, algo-respiratory-rate, algo-activity-classification, algo-posture-detection, algo-fall-detection, algo-arrhythmia-classification
  • prior art notes: Discloses a single-use adhesive chest patch deriving single-lead ECG, HR, HRV, respiratory rate, skin temperature, posture, activity, and falls in one body-worn unit, streamed wirelessly — i.e. a packed multi-parameter vital-signs patch. Anticipates multi-parameter ECG-patch claims combining any subset of those measurements in one adhesive form factor from 2016. Product-side anchor for the patch × multi-parameter-vitals cross-cut alongside [[fda-k113862-irhythm-zio-patch-2011]] (the AFib-focused variant).

Polar H10 (2017) — research-grade chest-strap ECG heart-rate sensor (2017-01)

  • id: polar-h10-chest-strap-2017
  • corpus: private
  • form factor: garment
  • creator: Polar Electro Oy
  • disclosure: Polar Electro Oy. ‘Polar H10’ chest heart-rate sensor, released 2017 — a chest strap with two dry electrodes deriving a single-lead ECG, computing R-R intervals and heart rate, with onboard 1-session memory, dual-broadcast (BLE + ANT+ + 5 kHz GymLink), an accelerometer (relative orientation), and well-documented R-R-interval accuracy (often used as a gold-standard reference for consumer wearables).
  • ip status: patented
  • sensors: sensor-ecg, sensor-accelerometer
  • algorithms: algo-hr, algo-hrv, algo-arrhythmia-classification
  • prior art notes: Discloses a chest strap with two dry electrodes deriving single-lead ECG, with on-strap R-R-interval computation, multi-protocol broadcast (BLE + ANT+ + the 5 kHz GymLink legacy band), and accelerometer-assisted noise rejection. Anticipates chest-strap-ECG claims combining ‘dry textile/elastic chest electrodes’, ‘on-strap derivation of R-R intervals and HR’, and ‘multi-protocol simultaneous wireless broadcast’ from 2017. Product-side anchor for the garment/patch × ECG strap cross-cut; refines [[polar-sport-tester-pe2000-1982]].

Public domain (CC0 1.0). The corpus IS the prior art commons.

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