Kits for use in the treatment of vascular calcified lesions

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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C604S043000, C604S171000, C604S027000

Reexamination Certificate

active

06562020

ABSTRACT:

INTRODUCTION
1. Field of the Invention
The field of this invention is atherosclerosis and related vascular-conditions.
2. Background of the Invention
The formation of plaques or lesions, (atherosclerotic plaques or lesions) on cardiovascular tissue, such as the inner surface of blood vessels, aortic valves, etc., is a major component of cardiovascular disease. Many atherosclerotic plaques and lesions are characterized by the presence of mineral deposits, i.e. they are calcified. Calcified lesion formation on prosthetic devices is also a problem in current cardiovascular disease treatment protocols. For example, calcification is an important limitation on the useful life expectancy of bioprosthetic valves, and accounts for over sixty percent of the cardiac bioprostheses failures.
A variety of different protocols have been developed for treating cardiovascular diseases associated with the presence of calcified lesions. Such treatment methodologies generally involve mechanical removal or reduction of the lesion, and include: bypass surgery, balloon angioplasty, mechanical debridement, atherectomy, valve replacement, and the like. Despite the plethora of different treatment strategies that have been developed for the treatment of cardiovascular disease, there are disadvantages associated with each technique, such as tissue damage, invasiveness, etc. For example, restenosis is a common complication that results in arteries in which lesions have been mechanically removed.
As such, there is continued interest in the development of new treatment protocols for the removal of vascular calcified lesions from vascular tissue, as well as kits of components that are used in such protocols.
Relevant Literature
U.S. Patents of interest include: U.S. Pat. Nos. 4,445,892; 4,573,966; 4,610,662; 4,636,195; 4,655,746; 4,824,436; 4,911,163; 4,976,733; 5,059,178; 5,090,960; 5,167,628; 5,222,941; 5,380,284; 5,443,446; and 5,462,529.
SUMMARY OF THE INVENTION
Kits for use in the treatment of vascular calcified lesions are provided. The subject kits include at least one of: (a) a fluid delivery means for conveying fluid to and from a vascular site; and (b) a dissolution fluid for at least partially dissolving the target lesion. In many embodiments, the kits include both of these components. The subject kits further include instructions for treating vascular calcified lesions with the contents of the kit, where the instructions are typically recorded on a recording medium, e.g. printed on a substrate, such as paper.


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