Intersection cross-cut: `patch` ∩ `sensor-ecg`

Axes: form_factor × sensors

9 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).

Patel et al. (2012) — ‘A review of wearable sensors and systems with application in rehabilitation’ (2012-04-20)

id: patel-bonato-2012-wearable-sensors-rehab-review
corpus: academic
form factor: other
creator: Shyamal Patel / Hyung Park / Paolo Bonato et al.
disclosure: Patel S, Park H, Bonato P, Chan L, Rodgers M. ‘A review of wearable sensors and systems with application in rehabilitation.’ Journal of NeuroEngineering and Rehabilitation 2012;9:21.
ip status: public-domain
sensors: sensor-accelerometer, sensor-gyroscope, sensor-emg, sensor-ecg, sensor-ppg, sensor-pressure-skin
algorithms: algo-gait-analysis, algo-activity-classification, algo-fall-detection, algo-tremor-detection, algo-bradykinesia-detection, algo-posture-detection
prior art notes: Reviews, as of 2012, wearable inertial/EMG/pressure sensor systems for movement and physiological monitoring in rehabilitation and chronic-disease management — gait analysis, activity and posture classification, fall detection, tremor and bradykinesia quantification (Parkinson’s), with the sensor placements (foot/insole, shank, thigh, trunk, wrist, forearm) and algorithms. Prior art for wearable movement-disorder and gait-monitoring claims reciting any of the placements/analytics surveyed; collected and published by 2012. General anchor for the gait / tremor / activity cross-cuts.

Mukkamala et al. (2015) — ‘Toward Ubiquitous Blood Pressure Monitoring via Pulse Transit Time: Theory and Practice’ (2015-08)

id: mukkamala-2015-ptt-cuffless-bp-review
corpus: academic
form factor: other
creator: Ramakrishna Mukkamala et al.
disclosure: Mukkamala R, Hahn J-O, Inan OT, Mestha LK, Kim C-S, Töreyin H, Kyal S. ‘Toward Ubiquitous Blood Pressure Monitoring via Pulse Transit Time: Theory and Practice.’ IEEE Transactions on Biomedical Engineering 2015;62(8):1879-1901.
ip status: public-domain
sensors: sensor-ecg, sensor-ppg, sensor-cuffless-bp-ptt, sensor-cuffless-bp-tonometry
algorithms: algo-pwv-bp-estimation
prior art notes: Canonical 2015 review of cuffless blood-pressure estimation by pulse transit time / pulse arrival time / pulse wave velocity: the physiological models, the practical sensor configurations (ECG+PPG, dual PPG, ballistocardiogram+PPG), the calibration strategies, and the accuracy limitations. Prior art for cuffless-BP wearable claims reciting any of the configurations or calibration approaches surveyed here — they were collected, modeled, and published by 2015. Combined with watch/ring/patch form-factor disclosures, makes wearable PTT-based BP an obvious combination under [[obviousness-template]].

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]].

Heikenfeld et al. (2018) — ‘Wearable sensors: modalities, challenges, and prospects’ (2018-01-16)

id: heikenfeld-2018-wearable-sensors-lab-on-chip-review
corpus: academic
form factor: other
creator: Jason Heikenfeld et al.
disclosure: Heikenfeld J, Jajack A, Rogers J, Gutruf P, Tian L, Pan T, Li R, Khine M, Kim J, Wang J, Kim J. ‘Wearable sensors: modalities, challenges, and prospects.’ Lab on a Chip 2018;18(2):217-248.
ip status: public-domain
sensors: sensor-ppg, sensor-ecg, sensor-eeg, sensor-glucose-cgm, sensor-lactate, sensor-cortisol, sensor-skin-temperature, sensor-bioimpedance
prior art notes: Authoritative 2018 review collecting wearable sensing across modalities — physical (motion, BCG/SCG, mechanoacoustic), electrophysiological (ECG/EMG/EEG), optical (PPG/SpO2, near-IR), thermal, electrochemical (sweat, saliva, tears, interstitial), and stimulation-coupled — across form factors (patch, watch, tattoo, contact lens, garment) and the challenges of body-fluid sampling, calibration, motion-artifact handling, and skin-electronics interfacing. Prior art establishing that the modality/form-factor combinations enumerated here were collected and surveyed by 2018; useful against later claims to those combinations. General anchor.

BioIntelliSense BioSticker (2019) — long-wear adhesive chest patch with extensive multi-parameter monitoring (2019-12)

id: biointellisense-biosticker-2019
corpus: private
form factor: patch
creator: BioIntelliSense, Inc.
disclosure: BioIntelliSense, Inc. ‘BioSticker’ single-use adhesive medical-grade biosensor, FDA-cleared 2019 — a chest patch with up to 30-day wear continuously measuring skin temperature, single-lead ECG-derived heart rate at rest, respiratory rate at rest, body position, activity (steps, cadence, gait), sleep, cough, vomiting events, and falls, with wireless upload.
ip status: patented
sensors: sensor-ecg, sensor-accelerometer, sensor-skin-temperature, sensor-microphone-air
algorithms: algo-hr, algo-respiratory-rate, algo-activity-classification, algo-posture-detection, algo-fall-detection, algo-cough-detection, algo-gait-analysis, algo-sleep-staging
prior art notes: Discloses a single-use 30-day adhesive chest patch combining skin temperature, resting HR-from-ECG, resting RR, posture/activity, sleep, cough and vomiting event detection, and falls — i.e. an unusually broad multi-parameter long-wear patch with explicit event-detection (cough, vomit) classifiers. Anticipates long-wear multi-parameter patch claims from 2019, including the event-detection (cough/vomit) elements that some later patents recite. Product-side anchor for the patch × long-wear multi-parameter cross-cut.

Intersection cross-cut: patch ∩ sensor-ecg