Surgery – Cardiac augmentation
Reexamination Certificate
2002-01-30
2004-02-24
Getzow, Scott M. (Department: 3762)
Surgery
Cardiac augmentation
Reexamination Certificate
active
06695761
ABSTRACT:
FIELD OF THE INVENTION
An artificial heart device which contains fluted flow chambers, a heater, and devices for producing sound waves, electromagnetic radiation, pressure pulses, and magnetic lines of flux.
BACKGROUND OF THE INVENTION
Mechanical pumps and other circulatory support devices are being developed and utilized to replace or augment biological hearts in animals and humans. These devices are intended to replace or support damaged or diseased hearts and have proven capable of sustaining experimental animals and humans for various periods.
Various parameters of blood flow and heart action are important to long-term patient survival. For example, the heart produces a pulsing biomagnetic field in the space around the body that can be measured by the magnetocardiogram. While these pulsing biomagnetic fields are being increasingly utilized for diagnostic purposes, these fields also have physiological significance for the functioning of the organism as a whole.
It is known that natural hearts produce a variety of energetic pulsations. Some of these, such as the sound, electrical, and pressure pulses, measured respectively with the stethoscope or phonocardiogrph, electrocardiogram, and various pressure recording devices (manometers, kymograms, ballistocardiograms), are well understood and widely utilized as diagnostic indicators of heart and circulatory health. Less well known is the thermal or heat pulse produced by each contraction of the heart muscle.
Likewise, the pumping of the blood sets up important neural signals because of the operation of the aortic and carotid baroreceptor system.
While the focus of medical research and clinical practice has been on the utility of the various pulsations as diagnostic indicators, little attention has been given to the possibility that such energetic pulsations, electromagnetic, acoustic, photonic, thermal, mechanical, and so on, serve functional purposes in the overall economy and integration of organismal functioning. For example, a theory about the possible roles of the various energetic pulsations is disclosed in an article published in 1996 by L. G. Russek and G. E. Schwartz with the title “Energy Cardiology: A Dynamical Energy Systems Approach for Integrating Conventional and Alternative Medicine” published in “Advances: The Journal of Mind-Body Health,” in Volume 12 on pages 4-24. Russek and Schwartz refer to the circulatory system and the blood flowing through it as a “dynamical energy system” that communicates information throughout the body, to every cell, integrating a variety of system-wide processes. Implicit in this model is the role of the blood as a systemic communication system by virtue of its high conductivity for electrical, mechanical, acoustic, and other energetic pulsations. Hence the vibratory properties of the circulation are conceived by Russek and Schwartz to form a dynamical system with a variety of regulatory roles. Research by others, to be cited below, supports this view.
It is recognized that complications associated with cardiac assist and replacement devices are multifaceted, and include multisystem organ failure, as is disclosed in a book edited by E Braunwald, D P Zipes and P Libby with the title “Heart Disease, A textbook of cardiovascular medicine” 6th edition, published by W B Saunders Company in Philadelphia on page 609 of Volume I. The prevalence of systemic complications following implantation of partial or total artificial heart devices is indicative of deficiencies that need to be overcome.
Systemic complications from the use of artificial hearts are also supportive of the dynamical energy theory developed by Russek and Schwartz and referenced above. Specifically, the Russek and Schwartz theory has implications for heart replacement therapies because it points toward the heart as a fundamental dynamic synchronizer producing rhythmic information that affects diverse systems. Failures of artificial cardiac support systems to maintain life for extended periods may be a reflection of disturbances in the cardiac coordination system postulated by Russek and Schwartz.
These concepts and observations also have implications for the patient with a weakened or damaged or diseased heart. Heart failure, for example, has a variety of systemic consequences, some of which obviously arise from decreased perfusion of various organs and tissues, and some of which may arise from changes in other physical characteristics of the blood flow addressed by this patent.
Understanding of the significance of the electrical signals generated by the heart has been expanded by recent discoveries concerning the frequency spectrum of the electrocardiogram and the corresponding biomagnetic spectrum as recorded with the magnetocardiogram. This information is cited here because an implanted artificial heart will obviously not produce an electrocardiogram or magnetocardiogram of a healthy, natural heart, and will be deficient in other energetic pulsations and rhythms as mentioned above, and these deficiencies could have local and systemic implications and affect long term patient survival.
Specifically, heart rate variability, measured with the electrocardiogram, can be converted mathematically into power spectral density, a widely used non-invasive clinical test of integrated neurocardiac functioning, as disclosed by Z Ori, G Monir, J Weiss, X Sayhouni and D H Singer in an article published in 1992 with the title, “Heart rate variability: Frequency domain analysis” published in Cardiology Clinics Volume 10 Number 3 on pages 499-537. These authors disclosed that heart rate variability distinguishes between sympathetic and parasympathetic regulation of the SA node. Subsequent research showed that heart rate variability is a predictor of a wide range of parameters, including mortality following myocardial infarction (as disclosed by R E Kleiger and J P Miller in 1978 in an article entitled “Decreased heart rate variability and its association with increased mortality after acute myocardial infarction” published in the American Journal of Cardiology Volume 59, pages 256-262, as well as in a 1998 paper by M T La Rovere, J T Bigger F I Marcus, A Mortara, P J Schwartz and ATRAMI Investigators entitled “Baroreflex sensitivity and heart-rate variability in prediction of total cardiac mortality after myocardial infarction” published in Lancet Volume 351, Number 9101 on pages 478-484), congestive heart failure (as disclosed in an article by P Saul, Y Arai, R Berger, L Lilly, W Colucci, and R Cohen published in 1988 with the title “Assessment of autonomic regulation in congestive heart failure by heart rate spectral analysis” published in the American Journal of Cardiology Volume 61 on pages 1292-1299), and coronary angiography (as disclosed by M W Saini et al. in 1988 in an article entitled “Correlation of heart rate variability with clinical and angiographic variables and late mortality after coronary angiography” published in the American Journal of Cardiology Volume 62 on pages 714-717). Heart rate variability is also predictive of rejection risk following transplantation (as disclosed by T Binder, B Frey, G Porenta, G Heinz, M Wutte, G Kreiner, H Gossinger, H Schmidinger, R Pacher, and H Weber in 1992 in an article entitled “Prognostic valve of heart rate variability in patients awaiting cardiac transplantation” published in Pacing and Clinical Electrophysiology Volume 15 on pages 2215-2220), it characterizes psychological illnesses including major depression (disclosed in 1991 by V. K. Yeragani et al. “Heart rate variability in patients with major depression” published in Psychiatric Research Volume 37 on pages 35-46) and panic disorders (as disclosed in an article by V K Yeragani, R Pohl, R Berger, R Balon, C Ramesh, D Glitz, K Srinivasan and P Weinberg entitled “Decreased HRV in panic disorder patients: a study of power-spectral analysis of heart rate” published in Psychiatric Research Volume 46 on pages 89-13), autonomic changes associated with hostility (as disclosed by R P Sloan, P A Shapiro, J T Bigger, E Bagiella, R C Stein
Gray Robert W.
Oschman James L.
Biomed Solutions LLC
Getzow Scott M.
Greenwald Howard J.
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