Our first filed patent application on the non-invasive monitoring and quantification of heart stroke volume, aortic heart valve conformance and compliance, descending aorta PWV, anelastic power law coefficients and quality factor, arterial power law coefficients, quality factor, secant Bramwell-Hill and longitudinal moduli, a subject's condition normotensive/hypertensive, and a subject's state normal/vasodilated/vasoconstricted has been approved in the USA, Notice of Allowance August 1st 2022, with all original twenty six (26) claims allowed without modification. The US patent will be published November 29th, 2022.
The accuracy of the quantified heart stroke volume is independent of the subject's condition and state, presence of vasoactive agents, blood loss, septic shock, plaque buildup, arteriosclerosis, blood clotting, etc., which is not the case for pressure based methods, such as PCM (Pulse Contour Method).
Australian, Canadian and European examinations are ongoing. Other patent applications are proceeding in the examination process to non-invasively monitor and quantify the heart stroke energy, aortic valve closure and rebound energies, the coronary artery diastolic suction filling wave volume and energy, the mitral valve conformance and compliance, descending aorta PWV, quality factor, secant Bramwell-Hill and longitudinal moduli, blood pressures by both occlusion and non-occlusion of the artery, and the in vivo whole blood viscosity, shear rate and shear stress in both the arteries and veins. Also, earlier this year we submitted a patent application to remove the skin pigmentation bias in pulse oximetry.
KardiaMetrix eBooks initial release date September 2023: The first ebook will be titled 'The Arterial Propagating Pulse and its Induced Wake of Pressure and Suction Waves: their Medical and Engineering Significance.' This ebook is tailored specifically for cardiologists, medical practitioners, biomedical engineers and scientists, since no medical or biomedical engineering school covers this essential material in their current curriculum.
Ready for the northern hemisphere fall semester of 2023, KardiaMetrix will be publishing additional ebooks for undergraduate and graduate studies in medicine and biomedical engineering to educate and transfer our unique knowledge of the arterial and venous waveforms and how to interpret such waveforms to quantify various hemodynamic parameters, such as heart stroke volume and energy, coronary artery diastolic suction filling wave volume and energy, conformance and compliance of the aortic and mitral valves, and in vivo properties of the arteries, including the descending aorta PWV, anelastic power law coefficients and quality factor, and the veins, plus in vivo whole blood viscosity determination at both high shear rates, during arterial flow, and at low shear rates in the venous network.
Background: We discovered that the carotid artery does not have any backward traveling 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 the above in a Patent Application, dated May 2018, see 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. Therefore, the current conception of a carotid pressure augmentation index is incorrect, since what is perceived as a reflected pressure augmentation in the carotid artery is incorrect, as it is a suction induced influence from the pulse excited induced wake of high frequency, highly dispersive shear waves. 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 backward traveling 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 closure, rebound and regurgitation volumes and their associated impacts on left ventricle ejected volumes and energies. This patent application disclosure, dated January 2019, can be viewed at WIPO IP Portal.
Radial Wrist Band TeleHealth Monitor: We are developing the radial artery wrist band as a non-invasive hypertensive/hypotensive patient care tele-medical device. The device can quantify the anelastic power law coefficients and secant moduli of a subject's radial artery, determine the subject's condition normotensive/hypertensive, the subject's state normal/vasodilated/vasoconstricted, plus quantify heart stroke volume and energy, aortic valve closure and rebound volumes and energies, aortic valve conformance and compliance, descending aorta PWV, anelastic power law coefficients and quality factor. Blood volume status is determined from a 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, in which the blood pressures are determined by an approximately five (5) second occlusion of the artery, can be viewed at WIPO IP Portal. Later patent applications have been filed that can determine the arterial blood pressures by not occluding the artery, but by a small change in the tonometer housing applied pressure. This technology enables the carotid patch to quantify near central blood pressures on a continuous basis.
Carotid Patch Device: We are currently 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 current device can quantify carotid blood pressures, heart stroke volume and energy, aortic and mitral valve conformance and compliance, including valve closure, rebound and regurgitation volumes and energies, carotid artery anelastic power law coefficients and quality factor, decending aorta PWV, anelastic power law coefficients and quality factor, secant Bramwell-Hill and longitudinal moduli, coronary artery diastolic filling suction wave volume and energy, blood volume status, the subject's condition normotensive/hypertensive and state normal/vasodilated/vasoconstricted, and whole blood viscosity.
In Vivo Whole Blood Viscosity: 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 near real-time in vivo assessment of whole blood viscosity.
Heart Valve Study:
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 November 2023. 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, i.e. November 2023.
KardiaMetrix LLC is a recent startup, September 2020, based in Atlanta, GA, and London, UK, by medical practitioners and biomedical engineers following the discovery of assessing a person’s heart stroke volume, performance of their heart valves, descending aorta PWV, quality factor and compliance, the presence of any aortic aneurysm, coronary artery diastolic filling suction wave volume, whole blood viscosity, subject's condition hypertensive/hypotensive and state normal/vasodilated/vasoconstricted, blood pressure measurement without artery occlusion, all from patented and 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.