Methods for enhancing fluid flow through an obstructed...

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

Reexamination Certificate

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C604S508000, C604S509000, C604S264000, C604S096010, C604S912000

Reexamination Certificate

active

06533767

ABSTRACT:

INTRODUCTION
1. Technical Field
The field of this invention is vascular disease, particularly vascular diseases characterized by the presence of vascular occlusions, including both partial and total occlusions.
2. Background of the Invention
Vascular occlusions, which may be partial or total occlusions, play a prominent role in many types of vascular disease. Occlusions found in vascular disease may vary greatly in content, and are typically complex structures of two or more different types of components. Components found in vascular occlusions include: lipids; lipoproteins; proteins; including fibrinogen, collagen, elastin and the like; proteoglycans, such as chondroitin sulfate, heparin sulfate, dermatans, etc.; cells, including smooth muscle cells, epithelial cells, macrophages and lymphocytes; and minerals, e.g. calcium phosphates such as dahllite. An occlusion categorization system has been developed for use in characterizing vascular occlusions, where type IV, type V and type VI lesions, as defined in Stary et al., Arterioscler. Thromb. Vasc. Biol. (1995)15:1512-1531, are particularly relevant in vascular disease.
A variety of different protocols have been developed for use in treating vascular diseases characterized by the presence of partial or total occlusions. Such treatment methodologies generally involve mechanical removal or reduction of the size of the occlusion, and include: bypass surgery, balloon angioplasty, mechanical debridement, atherectomy, and the like.
Despite the plethora of different treatment strategies that have been developed for the treatment of vascular diseases associated with vascular occlusions, 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 occlusions have been mechanically removed.
As such, there is continued interest in the development of endovascular methods of treating vascular occlusions. Of particular interest would be the development of methods and devices suitable for use in the treatment of vascular occlusions which do not suffer from the disadvantages of currently employed devices and methods.
Relevant Literature
U.S. Pat Nos. of interest include: 4,445,892; 4,573,966; 4,610,662; 4,636,195; 4,655,746; 4,690,672; 4,824,436; 4,911,163; 4,976,733; 5,059,178; 5,090,960; 5,167,628; 5,195,955; 5,222,941; 5,370,609; 5,380,284; 5,443,446; 5,462,529; 5,496,267; 5,785,675; 5,833,650 and 5,951,458. Multi-lumen catheter devices are described in U.S. Pat. Nos. 4,329,994; 4,838,881; 5,149,330; 5,167,623; 5,207,648; 5,542,937; and 6,013,068.
SUMMARY OF THE INVENTION
Methods of enhancing fluid flow through a vascular site occupied by a vascular occlusion, as well as systems and kits for use in practicing the same, are provided. In practicing the subject methods, the vascular site is flushed simultaneously with a first dissolution fluid (e.g., an organic matter dissolution fluid and/or an inorganic matter dissolution fluid), and a second dissolution fluid attenuating fluid, where flushing is carried out in a manner such that only a surface of the vascular occlusion is contacted with the non-attenuated dissolution fluid. Examples of dissolution fluid/dissolution fluid attenuating fluid pairs include: (1) oxidizing agent fluid and fluid comprising oxidizable neutralizing agent; (2) surfactant fluid and phosphate buffered saline; (3) acidic solution and phosphate buffered saline; etc. Flushing is carried out in this manner for a period of time sufficient for fluid flow through the vascular site to be enhanced, e.g. increased or established. The subject methods, systems and kits for practicing the same find use in the treatment of a variety of different vascular diseases characterized by the presence of vascular occlusions, including both partial and total occlusions.


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