We discovered that the carotid artery does not have any wave reflections, which is contrary to all of the current literature, (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.
The arterial pulse trailing pressure and suction waves were first observed some 15yrs 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. 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, its ejected stroke volume and energy, but also the performance of the aortic and mitral heart valves, such as regurgitation volumes and their associated impacts on left ventricle ejected volumes and energies.
We are developing the radial artery wrist band as a Hypertensive 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. Systolic and diastolic blood pressures are determined from the wrist strap tensions, the pulse pressure and pulse volume change waveforms. The device will connect to an app for secure data transfer and analysis.
We are currently soliciting funding for a multi-participant proposed study of forty (40) heart valve patients non-invasively monitored before and after surgery by our carotid artery patch device. 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 proposed study of eighteen (18) months, the 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, approximately twelve (12) months into the proposed project.
If you are interested, the Executive Summary can be downloaded by clicking the image below. If you wish to receive the full proposal, contact details are provided in the Executive Summary.