Method and apparatus for monitoring and improving blood...

Surgery – Diagnostic testing – Cardiovascular

Reexamination Certificate

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C600S300000, C600S504000, C607S002000, C607S003000, C607S061000

Reexamination Certificate

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06537229

ABSTRACT:

FIELD OF INVENTION
The present invention relates to a method and apparatus for monitoring the blood circulation in a human being by resonance.
BACKGROUND AND SUMMARY OF INVENTION
The artificial heart is a device that can supply energy to blood circulation. Its principle is to supply energy to the blood system to keep blood circulating. However, the circulatory system of a human body is a very complex system, and the blood is not circulating only by the momentum of the blood itself. In fact, the heart pumps the blood by squeezing it out of the left ventricle, and then, there is a U-turn at the ascending aorta, which converts the kinetic energy into elastic energy, stored on the arterial wall. If we measure the energy composition in the circulatory system, the result will be about 98% in the form of elastic energy in the aorta, and only 2% in the form of kinetic energy. Furthermore, more than half of the 2% kinetic energy is in oscillatory form and thus, only less than 1% of the total energy that keeps blood moving forward is in momentum form. Recently, the applicant has derived a formula of pressure wave propagation, which can explain the blood transfer in arteries and organs by pressure waves and resonance. Please view the following papers authored or co-authored by the applicant, as well as the references thereof:
1. Wang Lin Y. Y., Chang S. L., Wu Y. E., Hsu T. L. and Wang W. K.,
Resonance: the missing phenomena in hemodynamics,
Circulation Research 1991, 69 pp. 246-249.
2. Yu G. L., Wang Lin Y. Y. and Wang W. K.,
Resonance in the kidney system of rat,
Am J of Physiol. 1994, 267 H1544-1548.
3. Wang Lin Y. Y., Chang C. C., Chen J. C., Hsin H. and Wang W. K.,
Pressure wave propagation in arteries—A model with radial dialatation for simulation the behavior of a real artery,
IEEE Engineering in Med. & Biol. January/February 1997, pp. 51-56.
4. Wang W. K., Hsu T. L., Chang H. C. and Wang Lin Y. Y.,
Effect of acupuncture at Tai
-
Tsih
(
k
3)
on the pulse spectrum,
Am. J. of Chin. Med. VVIV (3-4): pp. 305-313, 1996.
The transfer of energy from the outside of a body toward the circulatory system inside the body can thus be understood in many different principles and can be realized in many different structures. One of the examples is the traditional artificial heart. However, the applied energy of the traditional artificial heart need not be momentum (i.e. kinetic), rather, it can also supply pressure energy (i.e. elastic) along with the blood flow. If the artificial device is a total artificial heart, it should pump the blood like the real heart that converts the blood flow momentum into elastic energy on the arterial wall. The artificial heart should be connected to the ascending aorta, and let the ascending aorta arch to do this conversion work. If the artificial device is in the form of a ventricular assistant device, especially the left ventricular assistant device, the energy applied by the device can be found everywhere. Along the artery, it is better for this applied energy to be in the form of pressure energy and synchronized with the heartbeat. For both the total artificial heart and the left ventricular assistant device, it is better to utilize the pulsatile energy delivering design which will excite the resonance of the host organs and the artery such that the impedance of blood circulation can be minimized.
The total artificial heart must be pulsatile at a beating rate that is similar to the beating rate of the heart to be replaced by the artificial one. Thus, a monitor is required for following the condition(s) of blood circulation. If the artificial heart is working properly, the pulse, which measures the resonant condition of the circulatory system, will show a pattern very close to the normal one. However, if a patient is dying, his or her heartbeat will generally become faster and body will begin swelling, due to edema. Then, the heartbeat will become abnormal or even irregular. If an artificial heart can perform its function at this time, the pulse will be normalized and the edema situation will improve, so that the heart rate can become slower and normal and the patient's heart failure is no longer fatal.
This monitoring system is very important because it gives instructions to tune the heartbeat. Among the many other ways to control blood circulation, the tuning of the heartbeat is the most useful way. One of the other ways is by monitoring the power in the delivered pulsatile pulse. In a normal human being, the power of the heart is only about 1.7 W. This limit should not be exceeded by much (e.g., the tradition artificial heart does not exceed 10 W). Too much pulsatile energy delivered may tune the whole circulatory system into another equilibrium state, which will damage internal organs in the long run. Again, the level of power should be made based on the monitoring of the pulse. When the pulse becomes normal, it implies the energy provided is sufficient. Therefore, the artificial heart should work within a small range of heartbeats and deliver energy by trial and error in order to seek an optimized heartbeat. Moreover, the delivered energy that produces the best pulse can be measured at the artery.
As a matter of fact, the above-mentioned principle explains the mechanism, as well as the reasons, for heart rate variability in a healthy heart. In a healthy heart, the feedback system on the arteries as well as the heart itself includes monitoring the blood distribution, and feed back of the monitored information through the nerve system to control the heartbeat and contractile force (if the heart is capable of following the instructions and delivering the requested power). If the artificial heart is requested to perform like a real heart, the monitoring system of the real heart, which is done by the artery and nerve system must be provided. Pulse analysis is of the simple and efficient ways to monitor artificially. Thus, an effective artificial heart is required to include both an energy delivering system and a monitoring system, in order to give feedback instructions concerning how the artificial heart should modify its rate and energy for optimized performance.
With respect to a ventricle assistant device, the real heart still works in the chest of the patient. Although the native feedback system works, the heart fails to deliver the requested power. Under this circumstance, the monitoring system should consult the native system constantly by way of monitoring the pulse together with the native heartbeat. Will the heart follow the changing of the beat and the delivered energy? Is the pulse getting closer to be normal? Two conditions should be followed. One is the pulse spectrum and the other is the native heart rate. A systematic way is to follow the pulse spectrum with heart rate variability. If the pulse is getting normal, the native heart rate variability becomes larger (and vice-versa, the variability becomes smaller when the native heart is working harder). A larger variability indicates that the conditions are fine.
Pulse monitoring should be used in both the total artificial heart and the left ventricle assistant device, and heart rate variability may also be used in the left ventricle device as an additional monitoring factor.
From the theory of resonance mentioned above, the heart beats an impulse which is converted into elastic energy on the arterial wall of the ascending aorta. The elastic energy is stored in the whole arterial system. It is comparable to an elastic bag in the body. The diastolic pressure inflates this bag, while the systolic pressure propagates along the arterial wall and distributes more energy into each organ and tissue. The blood is squeezed by this pressure and flows out of any holes in the arterial network. The blood flow in the artery is for refilling the arterial openings, from which blood leaks into the tissue.
Another way of helping the circulatory system is to supply more energy to the arterial wall, without penetration, by connecting a tube.
Energy may be supplied directly to the blood insid

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