Device and method to modulate blood pressure by electrical...

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems

Reexamination Certificate

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C601S012000

Reexamination Certificate

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06681136

ABSTRACT:

BACKGROUND OF THE INVENTION
Hundreds of millions of people in the world suffer some type of detrimental blood pressure condition. In the United States it is estimated that 50 million individuals have hypertension (blood pressure over 140/90). Of these 50 million, only about 27% have their blood pressure controlled by a combination of medication, diet and exercise. Up to age 55, more males have hypertension than females. But after age 55, females catch up and about 75% have hypertension. Hypertension is a risk factor for damage to heart, brain, kidney and eyes. The organs concerned with blood pressure are the brain, endocrine glands, blood vessels (arterial & venous) and the heart.
Low blood pressure (hypotension) also occurs and has different consequences for substantial numbers of people. Some people operate their cardiovascular system at lower than normal pressure with little consequences. These people are often cold in their extremities and can be less energetic than they would be if they operated at usual pressure. Nonetheless, for most people an episode of hypotension can be immediately life threatening if not corrected. Hypotension causes general weakness and faintness because of insufficient blood flow to the brain. Posteriorly low blood is aggravated when a person gets out of bed or stands up quickly, causing syncope (fainting). Hence hypotension is a significant risk factor for falls in the elderly. Hypotension can be idiopathic (of unknown cause) or it can be the result of taking excessive amounts of high blood pressure treatment medications. Losing count of medication doses in the elderly often results in taking a second dose unknowingly. The doubling of a medication dose can result in over-treatment of hypertension and cause serious low blood pressure complications.
A number of medications are regularly and routinely used as a treatment method to lower or raise blood pressure. These medications reach endocrine control areas that can dovetail with the actions of the neural control network. Such medications have a well established place in medical treatment but are always a compromise in attaining the results desired and minimizing side effects.
Although blood pressure can be measured with devices directly implanted in the arterial blood stream most studies use noninvasive methods. Such modern methods encircle finger, wrist or arm by automatic devices that provide blood pressure and pulse rate. Usually blood pressure is measured routinely by a device called a sphygmomanometer which consists of a cuff that is wrapped around the arm and inflated. A stethoscope or microphone is utilized to listen to an artery. As the cuff is deflated the first sound of swishing blood is the systolic blood pressure. When deflation continues and sounds disappear, the diastolic blood pressure is provided. The systolic blood pressure is the pressure attained when the heart contracts and pumps blood throughout the body. The diastolic blood pressure measures the resting pressure on the artery walls between heart contractions.
The arteries are large blood vessels in tubular form that transport blood from the heart. Such arteries branch out into smaller blood vessels called arterioles which deliver blood to the tiniest vessels called capillaries. Such capillaries supply all the body's organs with blood containing oxygen and nutrients. The arterial network is muscular in nature with the ability to constrict or relax. Generally, constricted arteries raise blood pressure, and those that are relaxed and dilated, lower blood pressure. The arterioles can be constricted and relaxed by the brain to alter blood pressure and change pulse rate.
Arterial blood pulsates at higher pressure and is oxygen rich which gives it the red coloration. Veins containing oxygen-depleted blood are blue in color, and flow at lower pressure. One can visualize the blue blood coursing through veins on the top-side of the hands and other parts of the body surface.
The venous system makes up part of the low-pressure system and serves as a blood reservoir. Veins of the cardiovascular system collect blood from everywhere it has been pumped and then flows it back to the heart. The heart's right atrium then squeezes blood into the right ventricle which then pumps it to the lungs to exchange carbon dioxide for oxygen. The lungs then supply the oxygen enriched blood to the left atrium for loading into the powerful left ventricle which then circulates that blood via arteries, arterioles and capillaries that span the entire body.
The general term, “blood pressure” applies to arterial blood pressure in the circulation system. It fluctuates with each heart beat between a systolic maximum level during contraction and a minimum pressure during its diastolic phase. The geometric mean value is known as the pulse pressure of a human or animal.
Blood pressure is ever changing in response to body organ demands for oxygen, depending on any given organ's activities. Such oxygen supply must be adequate and not excessive and is supplied by the pumping action of the heart. The rate and tone of heart pumping coupled with the dilation or constriction of blood vessels controls blood pressure. Brain electrical signals coupled with hormone and neurotransmitter chemical action modulate the cardiovascular systems circulatory blood pressure. Some of the neural axons provide neurotransmitter chemicals at their pre-synapses which serves to fine-tune electrical signals as they enter the post-synapse prior to flowing into the heart neuroganglionic plexis and at the blood vessel efferent attachment points. The brain plays a role with its electrical signals for both direct organ control and to signal endocrine organs to produce hormones. Both endocrine and neural signals are in themselves variable so as to modulate responses in answer to overall blood pressure regulatory requirements. This means that there is infinite variability within the collection of available “brain stored programs,” for both the hypothalamus (endocrine) and medullopontine (neural switching) to provide efferent signals to fine-tune blood pressure.
The muscular control of arteries is exterted by the brain based on afferent nerve information on the status and need for more or less pressure by the various body organs. The brain also can constrict any severed ends of an artery to lower blood loss. Such is an example of how finite brain signals control vascular network activity. Neuron axon synapses can introduce chemical neurotransmitters at their gaps to modulate the traveling electrical signals before they instruct target organs. Such targets in the case of blood pressure regulation would be the heart and the blood vessels.
The peripheral nervous system conveys afferent (input) sensory information to the central nervous system (brain) on body and cardiovascular status. The role of the brain, then, is to compare such afferent data with stored information, and then to respond with efferent nerve impulse signals to modulate performance of the cardiovascular system (heart and blood vessels).
The brain is an organ with information integrating function, organ coordinating and instructional output ability. The spinal cord is an extension of the brain. The upward ascending brain structures include the medulla oblongata and then the pons followed by the mesencephalon (mid-brain) and cerebellum before reaching the diencephalon where the hypothalamus and the large cerebral hemispheres are located. The first three structures make up the brain stem and are the processing and control centers for blood pressure. The principal actors in blood pressure control are the medullopontine region and the hypothalamus.
It has been established that the electrical action for regulating cardiovascular blood pressure emerges from the medullopontine area via the vagus nerve bundle. The vagus nerve bundle contains both afferent and efferent nerves that travel long distances to numerous organs. The medullopontine area is keenly interactive with the body it lives in, to insure that the basic life functions ar

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