Apparatus and method for treating atherosclerotic vascular...

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Light application

Reexamination Certificate

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C607S094000, C607S088000, C606S003000

Reexamination Certificate

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06764501

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to an apparatus and method for treating atherosclerotic vascular disease by means of light radiation.
BACKGROUND OF THE INVENTION
Atherosclerotic vascular disease represents one of the major health problems in the world. It is the number one cause of death in the United States, being responsible for one third of all reported mortality on an annual basis. The magnitude of the problem is staggering; in the United States alone over 60 million people have some form of atherosclerotic vascular disease. In 1995, approximately 1,000,000 people died from this problem. Atherosclerotic vascular disease ranks as the leading reason for social security disability, limitation in physical activity, and hospital bed use accounting for 46 million bed days in 1994. The direct and indirect costs of treating this scourge is in the hundreds of billions of dollars on an annual basis.
Although research in this area has been intense, the exact cause of atherosclerotic artery disease remains unknown. Atherosclerosis is the descriptive term for thickened and hardened lesions of the arteries. It results from fatty deposits that build up in the innermost lining, or intima, of the artery. The lesions are generally eccentric and if they become sufficiently large, can occlude the artery and thus the blood supply to a tissue or organ, resulting in ischemia or necrosis. If this occurs, it often leads to the characteristic clinical outcomes of myocardial infarction (heart attack), cerebral infarction (stroke), gangrene of the extremities, etc.
The exact cause of the fatty build-up is not known although the stages of progression are well described, and certain risk factors well-identified, such as smoking, high cholesterol levels, obesity, diabetes etc. More recently, evidence has pointed to a potential infectious cause of atherosclerotic vascular disease. Cytomegalo virus, Chlamydia and Helicobacter pylori have all been associated with atherosclerotic disease. The infectious pathogens are presumed to cause chronic inflammation, which results in atherosclerotic deposition.
In one study involving Helicobacter pylori, 38 atherosclerotic plaques were obtained at carotid endocardectomy, and examined for the presence or absence of bacteria. The researchers used morphological and immunohistochemical techniques to do this, and a highly sensitive polymerase chain reaction method to search for Helicobacter DNA. As a control, the researchers examined 7 carotid arteries obtained at autopsy from subjects without carotid atherosclerosis. The researchers detected the presence of Helicobacter pylori DNA in 20 out of 38 atheromatous plaques, and morphological/immunohistochemical evidence of bacteria in 10 of the DNA-positive plaques. None of the 7 normal carotid arteries were positive for Helicobacter pylori (Ameriso, 2001).
If atherosclerotic artery disease were to be infectious in etiology, antibiotics probably would not work well due to lack of penetration into dense plaque.
In view of these and other deficiencies of the prior art it is the primary object of the present invention to provide an apparatus and method for treating atherosclerotic vascular disease using light radiation.
Another more specific object is to treat vascular disease of the character described using light radiation without significant damage to the vessel or surrounding body tissue.
A further object of the present invention is to provide an apparatus of the type described which is characterized by emitting radiation which is destructive to pathogenic microorganisms that cause and/or contribute to atherosclerotic disease without producing sufficient heat to damage body tissues.
Yet another object of the invention is to provide an apparatus of the character described which is small enough for insertion into relatively small blood vessels such as the coronary arteries but is also useful for treating blood vessels throughout the body including cerebral vessels and peripheral vessels that are partially or completely occluded by atherosclerotic plaque.


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