Oh, patents! Eko DUO wireless stethoscope + ECG design (5)

Copyright © Françoise Herrmann

The striking design of the EKO DUO, combining both stethoscope and ECG is (Electrocardiogram) is covered in the US Design patent USD851253S1, titled Mobile cardiac sensor. As a reminder, the difference between a utility patent and a design patent is significant, both in terms of content and form. According to the USPTO Manual of Patent Examination Procedure:

 “a utility patent” protects the way an article is used and works (35 U.S.C. 101), while a “design patent” protects the way an article looks (35 U.S.C. 171) [MPEP Chapt. 1502.01; [R-07.2015]].

Below, the design patent cover-page figure drawing, showing the ornamental aspects of the back and front of the device, together with an image of the marketed EKO Duo, also showing the back (push button) and front (dual sensors) of the device.  

References

EKO Duo(website) www.ekohealth.com

USPTO - MPEP – Chapt. 1502-01 – Distinction between design and utility patent.

https://www.uspto.gov/web/offices/pac/mpep/s1502.html

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

Oh, patents! Safe auscultation with the Eko CORE (3)

Copyright © Françoise Herrmann

The Eko CORE digital stethoscope attachment, an invention originally filed in 2015, in the utility patent application US2015257728 titled Stethoscope, Stethoscope Attachment and Collected Data Analysis Method and System, was designed to enable clinicians to convert their favorite analog stethoscopes into digital ones (1). The conversion from analog to digital not only enabled such prized features as sound amplification, noise cancelation, visualization of heart sounds on a dedicated app; storage, replay and sharing of recordings, it also opened up the possibilities of remote auscultation and diagnosis for underserved populations. Finally, if the attachment were designed in kid-friendly ways (e.g.; if it were to look like a butterfly), it was also anticipated that the Eko CORE digital attachment would then create a far friendlier experience for pediatric patients.

Five years later, within the unprecedented context of the COVID 19 pandemic, the Eko CORE digital attachment has generated renewed interest. Indeed, since the attachment is easily detached from the tubing and ear-pieces of a conventional stethoscope, the Eko CORE also arises as a device that enables safe auscultation in 5 easy steps, as shown in the below video. Five easy steps comprising:

1. Detaching the Eko CORE from the conventional stethoscope tubing.
2. Pairing the Eko CORE with a mobile device such as a smartphone.
3. Pairing wireless earbuds to a mobile device such as a smartphone.
4. Inserting the Eko CORE into a single-use protective sleeve, and the wireless earphones behind a mask or other personal protective equipment (PPE).
5. Proceeding with safe auscultation of the patient, with sound streaming wirelessly in real time, via Bluetooth® connection, to the smartphone, and from the smartphone to the wireless earbuds. 

________

Note (1): The original EKO CORE attachment invention was reviewed on April 1, 2015, at Patents on Soles of your Shoes.  

Reference

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

Oh, patents! WirelessThinklabs One stethoscope (2)

Copyright © Françoise Herrmann

Although the Thinklabs One wireless electronic stethoscopes were released in 2003, seventeen years prior to the COVID 19 pandemic, for all the reasons that make digital auscultation unquestionably superior to conventional auscultation, the devices are now also proven life-saving devices. Life-saving for front-line professionals, working within the context of the hazardous and contagious situations of the COVID 19 pandemic. Situations where professionals are required to wear hazmat suits, or other sorts of personal protection equipment (PPE), such as hoods, face masks and face shields. Indeed, use of a wireless stethoscope, such as the ThinkLabs One, effectively prevents breaking the protection afforded by PPE equipment. Thanks to wireless functionalities, it is also possible to safely auscultate in an isolation room while streaming data to a triage room in real-time, or to auscultate at bedside, while streaming to a professional in another room.  Likewise, it is possible to auscultate in one location, and to stream sounds at a far greater distance within the context of telemedicine.

In fact, ThinkLabs One stethoscopes are marketed as the “smallest and most powerful stethoscopes in the world”, considering the versatility and inclusiveness of their design. Sounds can be amplified 100x, not only to capture and filter heart, lung or blood pressure sounds in unprecedented ways, even through clothes or in chaotic ER environments, but also to enable use for professionals with hearing loss. Auscultatory sounds can even be streamed to programmable Bluetooth-enabled hearing aids. Thinklab One stethoscopes are also powerful enough to be used with disposable protective sleeves for each patient.

Many patents are associated with the Thinklabs One electronic stethoscope. However, the core invention of the Thinklabs One electronic stethoscope —the invention that made it possible to capture, selectively filter, and amplify, body sounds electronically with very little distortion, thereby setting it apart in a class of its own— is the capacitative Electromagnetic Diaphragm (EmD) invention. An invention that directly uses capacitance variation to transduce sounds from the body into electronic signals, without the use of a prior art microphone mounted behind the stethoscope diaphragm, or the use of a prior art piezo-electric crystal sensor connected to the stethoscope diaphragm. This invention is recited in US6498854, titled Transducer for sensing body sounds, a utility patent granted on December 24, 2002.

In the inventor’s own words:  

“I investigated various sensor methods and had many failures, as you'd expect in research. But one method performed beautifully - using capacitive sensing, where the diaphragm acts as one plate of a capacitor. It's really tricky getting such circuits to work well, but I was working in my garage in the middle of winter.” (Clive Leonard Smith, Thinklabs Founder, One designer and inventor)

 The abstract of this invention is included below, together with the patent Figure 8. The patent Figure 8 schematically represents the conductive stethoscope diaphragm 2, in contact with the patient’s body, forming a capacitance with a second plate 3; one or both plates comprising permanently charged material, thus creating an electrical field 80 between them, without relying on DC charging. The diaphragm 2 is mounted to the stethoscope housing, using a mounting clamp 9, made of rubber, to prevent vibrations, from the housing, to reach the surface of the diaphragm 2.

An acoustic-to-electrical transducer for sensing body sounds is disclosed. The transducer comprises a capacitive sensor, whereby a stethoscope diaphragm forms one plate of a capacitor, with the second plate of the capacitor being co-planar to the diaphragm. The capacitance of the two plates varies with the distance between them, said distance being modified by motion of the diaphragm in response to sound pressure. The sensor, circuitry, manufacturing methods and improvements are disclosed. [Abstract US6498854] 

An image of the elegant ThinkLabs One electronic stethoscope is also included above. The Thinklabs One electronic stethoscope looks different from a conventional acoustic stethoscope, with none of the bulky tubing or earpieces. Frequency amplification, corresponding to low pitch heart sounds captured with the bell of a conventional stethoscope, as well as the higher pitch lung sounds captured by the diagram of a conventional stethoscope, is selected using a  dedicated filter button on the perimeter of the Thinklabs One. An Alt (toggle) button enables users to switch filters for the purposes of toggling between their favorite two frequencies. For example, the Alt button is used for toggling between a preferred filter to capture low pitch heart sounds, and a preferred filter to capture high pitch lung sounds. Two additional buttons (plus and minus) on the periphery of the Thinklabs One enable adjustment of the volume. 

Reference

Thinklabs (website)  https://www.thinklabs.com

Oh, patents! Cordless stethoscopes for safe auscultation (1)

Copyright © Françoise Herrmann

Prior to the COVID 19 pandemic, electronic stethoscopes (e.g.; Eko Core, Thinklabs One or Littman 3200) were primarily known and touted for their superior sound quality, sound filtering possibilities (ie.; ambient noise reduction), the benefits of recorded digital data that can be streamed, shared, compared, annotated, forwarded and stored in medical records, and the general portability of the devices with no bulky tubing or earpieces, including their stylish design.

Within the context of the COVID 19 pandemic, Bluetooth-enabled, wireless digital stethoscopes became vital instruments of safety that enabled medical personnel to retain the full protection of their hazmat equipment, while auscultating patients that were infected, or potentially infected.

Interestingly, the following patent US7182733B2, filed Aug. 20, 2003, granted Feb. 27, 2007, titled Cordless stethoscope for hazardous material environments anticipated such threats as contagious diseases spreading through international air travel, coupled with threats of biological and chemical terrorism. Responding to the specific problematic situations of contagious or more generally hazardous environments that require working in hazmat suits, the invention offers safe auscultation, using a cordless stethoscope, equipped with magnetic induction coils for the transmission of auscultatory sounds, and in a later abandoned patent application US20070049838A1 also using radio frequencies. Thus, the inventive auscultation device, whether using magnetic induction or a combination of magnetic induction and radio frequencies, might be used wearing hazmat suits, without breaking any of the protection afforded by the suits, in highly contagious situations. The inventor, Keith Sauerland, specifically states:

It has come to my attention during  preparedness training for dealing with these threats that it is impossible for medical personnel to use a standard stethoscope when wearing a HAZMAT suit without compromising the integrity of the suit. Breaking the protective barrier of the HAZMAT suit defeats the purpose of wearing the suit and places medical personnel at risk.

As illustrated in the patent Figure 3 below, the invention stethoscope hardly looks like a conventional stethoscope. However, it is specifically designed for medical personnel wearing hazmat suits (as illustrated to the right with staff using the Spanish eKuore stethoscope). Specifically, the invention stethoscope is equipped with means for sending and transmitting sounds from an auscultation head to receivers within earpieces, or to a receiver clipped inside the hazmat suit. The preferred mode of transmission and reception is magnetic induction. The housing of the auscultation head is of a shape that compensates for any loss of fine motor skills associated with the use of heavy hazmat suit gloves, and it is fluid-tight so that it can be easily decontaminated. The cordless stethoscope is used outside of the hazmat suit to sense and transmit sounds, from the patient’s body, to a receiving device inside the hazmat suit, which converts the sounds into audible sounds that the user of the cordless stethoscope can interpret. Optionally, the cordless stethoscope may also include a microphone designed to capture voiced communication from the patient, which might otherwise not be heard through a hazmat suit. 

Below the abstract of this invention, together with the patent Figure 3, showing a cross-sectional view of the sound sensing device 20. In particular the patent Figure 3 illustrates the stethoscope head 30, the fluid-tight casing 70,  a power source 80, preferably a dry-cell battery located within the sound sensing device, a transmitter 120, an activation switch 100, inside an activator switch opening 170, with indicator light 210 and indicator light opening 200. The housing 70 has an opening 160 for receiving the stethoscope head 30, comprising a diaphragm 220, and an auscultation bell 230, a low-frequency response microphone 260 for sensing auscultatory sounds produced by the patient, a first fluid-tight cover 240 and fluid-tight members 250 connecting the stethoscope head 30 and opening 160 to maintain the fluid integrity of the housing 70, while also acting to as shock absorbers for the stethoscope head 30. The stethoscope head 30 is connected via circuits to the switch 100 and the transmitter 120.  When the switch 100 is pressed, the microphone 260 is activated. The outside of the housing provides a nonslip grip. A small ring 150 enables to attach the device via a wrist or neck strap (not illustrated in the patent figure) to prevent accidental drop damage. 

A cordless stethoscope for use in hazardous material environments comprising a fluid tight hand held sound sensing device having a stethoscope head for sensing auscultatory sounds, a transmitter for transmitting sounds sensed by the device, a receiver for receiving transmissions from the transmitter and an ear piece for converting the received transmissions into audible sound. The housing is sized and shaped for being grasped by a gloved hand and is fluid tight for decontamination purposes. The sound sensing device may further comprise a microphone for sensing otherwise inaudible voice communications from a patient. The transmitter and receiver preferably uses magnetic induction transmissions to transmit sounds through barriers such as hazardous material suits that may be worn by clinicians during treatment of patients in possible hazardous material situations. [Abstract US7182733B2]

References

EKO Stethoscopes - https://www.ekohealth.com/

Thinklabs One - https://www.thinklabs.com/ 

3M Littmans Stethoscopes - https://www.littmann.com/3M/en_US/littmann-stethoscopes/

Ekuore Stethoscopes (Europe) - https://www.ekuore.com/shop/

Oh, patents! EKO™ Core

Copyright © Françoise Herrmann

If you do not want to ditch your analog stethoscope, and at the same would love to use a digital one, how about purchasing an electronic attachment?

The EKO™ Core stethoscope attachment will transform almost any analog stethoscope into a digital one, and stream the data collected during examination directly to your portable phone or tablet via wireless Bluetooth™ connection. 

US2015257728 titled Stethoscope, Stethoscope Attachment and Collected Data Analysis Method and System, recites this invention developed and tested at UCSF. 

Beyond the reduced costs of an attachment only for negotiating the switch from analog to digital auscultation, the most important advantage is that the analysis and diagnosis of sounds no longer depend exclusively on the practitioner’s listening skills.

Indeed, when using digital auscultation, sounds can be recorded and transferred to another device for analysis and diagnostic purposes. 

However, there is yet another advantage recited as part of this invention, since there are provisions for the ornamental aspects of the attachment to be be specifically designed with an appeal for pediatric patients, for example with butterfly wings.

Thus, the EKO™ core attachment, optionally packaged in a way that is appealing to children, is designed to attach to a conventional analog stethoscope, to convert analog to digital signals, and to send them wirelessly to a storage and analysis device equipped with an EKO™ app. This results in possibilities of remote diagnosis in underserved populations, collection and storage of examination data for educational and training purposes, and kid friendly experiences in primary care. 

The Abstract of this invention, disclosed in US2015257728 titled Stethoscope, Stethoscope Attachment and Collected Data Analysis Method and System, is included below. A patent figure drawing and an image of the device are also included. 

A device for converting acoustic data collected by a stethoscope into digital data for transmission to a processor for storage and/or comparison with data stored in a database, and to optionally provide computer generated suggestions for diagnosis, is provided in the form of an in-line device interposable between a head of the stethoscope and an acoustic transmission portion of the stethoscope, or is integral with the head, and advantageously has the appearance of an icon of pleasing appearance, for example, a butterfly, in which are incorporated the structural requisites of a functioning stethoscope and/or capabilities for receiving and transmitting to a diagnostician, audio signals gathered from patient examination, and optionally also other data collected at examination and/or following the examination. The butterfly-shaped device, includes a central body advantageously serving as a conduit for transmitting sound received from the patient to the physician or a remote system for analysis and diagnosis.                 Abstract US2015257728

References
EKO™ Core
https://ekodevices.com/