We discovered that the carotid artery does not have any wave reflections, which is contrary to all of the current literature (i.e. augmentation index, etc.). The current state of the art does not realize that the propagating arterial pulse excites a wake of high frequency, highly dispersive shear waves that produce pressure and suction waves trailing the arterial pulse (i.e. the pulse is propagating in a 'slow' medium). Geophysics literature has known this since the early 1960's, as a Stoneley wave propagating in a 'slow' medium. One of our engineers with a geomechanics/geophysics background assisted us in identifying the arterial pulse excited wake of high frequency, highly dispersive shear waves some years ago. We first disclosed this in May, 2018 in a Patent Application, which can be viewed through the WIPO IP Portal.
The arterial pulse trailing pressure and suction waves were first observed some fifteen years ago by Wave Intensity Analysis (WIA) reseachers in the carotid, brachial and radial arteries. However, due to limitations of WIA, they incorrectly determined the traveling directions of these waves, and, even today, they are still misidentified as reflections. If you non-invasively monitor a subject's left radial artery for two states, at rest and vasodilated, you can show conclusively that the pulse trailing pressure and suctions waves are not due to reflections. Not only does the arterial pulse excite a wake of trailing pressure and suction waves in the systemic circulation, but it also occurs in the pulmonary circulation, and, to a much lesser degree, in the venous system.
The carotid artery, being void of reflections, is thus an ideal location to non-invasively monitor the performance of the heart's ejected stroke volume and energy, but also the performance of the aortic and mitral heart valves, such as their regurgitation volumes and their associated impacts on left ventricle ejected volumes and energies. One of our Patent Applications for this disclosure can be viewed at WIPO IP Portal.
We are developing the radial artery wrist band as a non-invasive hypertensive/hypotensive patient care tele-medicine device. The device can quantify the anelastic power law coefficients and secant moduli of a subject's radial artery, at rest, vasodilated and vasocontracted. Blood volume status is determined from frequency domain arterial waveform analysis. Systolic and diastolic blood pressures are determined from the wrist band tensions and the pulse pressure and pulse volume change arterial waveforms. The device will connect to an app for secure data transfer and analysis. One of our Patent Applications for this disclosure can be viewed at WIPO IP Portal.
We are enhancing our analog wired carotid artery patch device for the upcoming study of forty (40) heart valve patients monitored non-invasively before and after surgery by our carotid device. The Covid-19 project on the non-invasive in near real-time in vivo assessment of whole blood viscosity (WBV) and erythrocyte aggregation/deaggregation (A/D) has been given top priority over our other activities.
COVID-19 thrombosis is caused by elevated blood viscosity due to hyperfibrinogenemia. Fibrinogen concentrations can be extraordinarily high in severe COVID-19, reaching 10-14 g/L. Fibrinogen and other acute-phase reactants increase whole blood viscosity and foster erythrocyte aggregation.
The non-invasive in vivo in near real-time assessment of whole blood viscosity (WBV) and erythrocyte aggregation/deaggregation (A/D) utilizes a wrist band device over the dorsal vein to rapidly determine non-invasively in near real-time the subject's WBV and erythrocyte A/D. This Covid-19 project has an extremely high priority due to the urgent need for such near real-time in vivo assessment.
KardiaMetrix LLC is a recent startup, September 2020, based in Atlanta, GA, London, UK & Nashville, TN, by medical practitioners and biomedical engineers following the discovery of assessing a person’s heart stroke volume, performance of their heart valves, the presence of any aortic aneurysm, their blood viscosity, hypertensive/hypotensive state and blood pressure measurement without a cuff, all from patent pending non-invasive measurements of their arterial and venous waveforms. If you are interested in the non-invasive assessment of blood volume status and Pulmonary Capillary Wedge Pressure (PCWP) visit our affiliated company at www.VoluMetrix.com.
The study of forty (40) heart valve patients monitored non-invasively before and after surgery by our carotid artery patch device is planned to begin in late January 2021. The carotid patch device is currently being enhanced for limited manufacture prior to the study. The carotid patch device can monitor heart stroke ejected volume and energy over each cardiac cycle. Regurgitation volumes and energies for the aortic and mitral valves plus their associated impacts on left ventricle ejected volume and energy are also quantified over each cardiac cycle.
During the next eighteen (18) months, the current analog wired carotid patch device will be enhanced to be a digital wireless device, with secure data transfer and analysis. The enhanced wireless device will be 510(k) submitted to the FDA in approximately twelve (12) months.