DRUG ELUTING SCULPTING BALLOON
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Accused Products
Abstract
A plaque-modifying balloon and method for use in an endovascular procedure includes an elongated balloon that defines a longitudinal axis and is inflatable from a first deflated configuration to a second radially expanded configuration. One or more plaque-modifying elements are mounted on the outside of the inflatable balloon. Optionally, a compressible sheath made of a relatively low durometer, flexible material is mounted on the balloon to cover the elements during transit of the plaque-modifying balloon to and from the treatment site.
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Citations
42 Claims
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1. -23. (canceled)
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24. A plaque-modifying catheter system comprising:
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a catheter having a proximal end, a distal end and an intermediate section therebetween; an inner lumen between the proximal and distal ends through which a medical device or fluid may pass without interruption or interference; an expandable balloon located between the proximal and distal ends of the catheter and circumscribing at least the intermediate section of the catheter, the balloon receiving a pressurizing fluid between the catheter and the balloon which causes the balloon to inflate, the balloon having an outer surface; an assembly of plaque-modifying elements mounted on at least a part of the outer surface of the balloon, wherein the plaque-modifying elements are separated from each other before, during, and after balloon expansion, thereby creating an array of weakened areas in a vessel wall when the plaque-modifying elements are urged into contact with the vessel wall by the pressurizing fluid inflating the balloon and the plaque-modifying elements impinging on the vessel wall, thereby fracturing hardened tissue and creating the weakened areas therein, at least some of the plaque-modifying elements having a tip situated atop a plaque-modifying element, the tip having a cross section geometry selected from the group consisting of an oval, a circle, a dome, an ellipse, an “
x”
shape, a star shape and a “
y”
shape; anda drug bonded to the outer surface of the balloon that is by contiguity between the expandable balloon and the vessel wall eluted into the vessel wall. - View Dependent Claims (25, 26, 27, 28, 29, 30, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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31. A method for treating a stenosed region in a blood vessel, the method having steps including:
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positioning and expanding an inflatable balloon that carries on its outside surface a drug and supports an assembly of plaque-modifying elements to radially outwardly displace the plaque-modifying elements within the stenosed region, the assembly extending from an outer surface of the balloon, the plaque-modifying elements being disposed between the balloon and the stenosed region, imparting a modified pattern by the plaque-modifying elements in the stenotic material associated with an inner wall of the blood vessel as the balloon assumes an expanded state and elutes the drug to the inner wall of the blood vessel; and radially contracting the balloon so that the plaque-modifying assembly lies in folds of the balloon as the balloon is withdrawn.
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32. A method for dilating a stenosed region in a blood vessel, said method comprising:
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expanding an assembly of plaque-modifying elements to radially displace the elements outwardly within a stenosed region of the blood vessel; wherein the elements are disposed between an expansible balloon and the stenosed region and expanding the balloon causes the elements to modify the stenotic material to create an impression in or fracture the stenotic material about the inner wall of the blood vessel as the balloon is in an expanded state; delivering a drug from the outside of the balloon to the stenosed region; and radially contracting the balloon.
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Specification