Monday, October 26, 2020

Oh, patents! Eko DUO wireless stethoscope + ECG for telemedicine (4)

Copyright © Françoise Herrmann


The EKO DUO combines stethoscope + ECG (Electrocardiogram) into a single palm-held device. In a nutshell, the EKO DUO combines a cartful of complicated medical devices into the palm of a user’s hand – not only the clinician’s hand, but most importantly a patient’s hand, within the context of telemedicine.

If cost-effectiveness and the continuity of specialty care, together with other diagnostic and monitoring benefits of telemedicine, were steadily emerging in such contexts as remote and underserved populations, prior to the COVID 19 pandemic, the pandemic abruptly drove mass migration to telemedicine of both urgent and non-urgent care. For example, Mann, et al.,(2020) reported in a study of the NYU Langone Health system that: "Between March 2 and April 14, 2020, telemedicine visits increased from 102.4 daily to 801.6 daily. (683% increase) in urgent care after the system-wide expansion of virtual urgent care staff in response to COVID-19.” Similarly, Mann, et al. reported that non-urgent care ambulatory care visits across specialties, <50 prior to March 19, increased to >1000 video call visits on March 19, and to >7000 in the 10 subsequent days (representing >70% of all ambulatory volume). They stated: “Over an approximately 6-week period, there were 144 940 video visits conducted, involving 115 789 unique patients and 2656 unique providers.“ The only constant reported was the mean satisfaction level (for both patients and providers) which remained 4.38/5 before, and after, the quantum increase in video call visits.

Although the horrific circumstances of the COVID 19 pandemic in NYC were unanticipated (1), indeed unimaginable and still unspeakable, the delivery of care via telemedicine is precisely the sort of context for which the EKO Duo stethoscope + ECG was invented. Recited in the US utility patent US20200107745A1 titled Wireless cardiac sensor, filed on April 9, 2020, the wireless EKO Duo device is designed for patients to use on themselves, at home or in other non-clinical settings. The device is even designed for single-hand patient operation, using a button on the back surface of the device to initiate recordings. (See the image of the back of the Eko Duo sensor, next to a smartphone display of the recorded data, included to the right.)

Heart and lung sounds, and ECG data, are simultaneously captured, respectively via audio transducer and ECG transducer electrodes within the sensor, and wirelessly transmitted to a personal electronic device, such as a smartphone, tablet, or personal computer, using a Bluetooth® link. The personal electronic device is equipped with downloadable software to process the recorded data (e.g.; to display, analyze, store, and/or send the data), and to give instructions to the user on positioning and initiating the recording. In turn, both the captured ECG and phonogram data are then forwarded, via wide-area network, to a healthcare provider, or to a centralized server.

The abstract of the Eko Duo stethoscope + ECG wireless device is included below, together with the Figure 1 drawing of the wireless device, extracted from the patent. The patent Figure 1 shows a front perspective view of the EKO Duo cardiac sensor device 100, comprising the housing 105 for the device circuitry, the ECG transducer electrodes 110A and 110B, positioned on each side of an acoustic transducer 112. When correctly positioned, on the left pectoral region of a user’s chest, the two electrodes 110A and 110B capture the “electrical signals on a person's skin resulting from depolarization of the person's heart muscle during each heartbeat”. Likewise, the acoustic transducer 112, positioned between the two electrodes 110A and 110B, captures the user’s heart and lung sounds. Together the electrodes 110A and 110B, and acoustic sensor 112, capture both mechanical and electrical characteristics of the user's heart. The absence of lead wires for the electrodes prevents entanglement. The EKO Duo cardiac sensor design is further optimized to provide: 1. gripping comfort, 2. secure use against all body types, 3. adequate distance between electrodes for providing accurate signal quality, and 4. sufficient diameter of the audio transducer to provide optimal detection of heart and lung sounds.

A wireless cardiac sensor is provided. The sensor may be utilized by a patient, on themselves, in an at home or other non - clinical environment. A sensor housing contains ECG electrodes and an audio transducer to simultaneously capture heart sound and ECG data with a single device. The ECG electrodes may be positioned on opposite sides of, and preferably adjacent to, an audio transducer sensor, for placement against a user's chest. The wireless cardiac sensor may include a button on a surface opposite the ECG electrodes and audio sensor, facilitating one - handed operation by a patient. The sensor transmits acquired data to a personal electronic device, such as a smartphone, via a wireless communication link. The personal electronic device may in turn transmit data to a centralized server and/or health care provider devices, via a wide area network. [Abstract US20200107745A1]

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Note (1) During the short timeframe of the Spring of 2020, New York City suffered an approximated 25,000  COVID 19-related casualties, the most in the US. Ref.: John Hopkins Coronavirus Resource Center   https://coronavirus.jhu.edu/data/state-timeline/new-confirmed-cases/new-york  

References

EKO (website) https://www.ekohealth.com/ 

 Mann, D.M.Chen, j.Chunara, R.  and P. A. Testa (July, 2020). COVID-19 transforms health care through telemedicine: Evidence from the field. Journal of the American Medical Informatics Association, Volume 27, Issue 7, July 2020, Pages 1132–1135.  https://doi.org/10.1093/jamia/ocaa072  https://academic.oup.com/jamia/article/27/7/1132/5824298

Kruse, C.S., Karem, P., Shifflett, K., Vegi, L., Ravi, K. and M. Brooks (Jan, 2018). Evaluating barriers to adopting telemedicine worldwide: A systematic review. J Telemed Telecare - 2018 Jan;24(1):4-12. doi:10.1177/1357633X16674087   https://journals.sagepub.com/doi/10.1177/1357633X16674087