Catheter for tissue dilation and drug delivery
First Claim
1. A process for treating tissue at a treatment site within a body lumen, comprising:
- providing an elongate flexible catheter having a flexible treatment sheath mounted to a distal end region of the catheter and a dilatation balloon within the flexible treatment sheath, wherein the flexible treatment sheath is formed of an elastic material and the dilatation balloon is formed of a substantially inelastic material;
intraluminally advancing the elongate flexible catheter until the flexible treatment sheath is adjacent a predetermined treatment site;
while maintaining the dilatation balloon in an unexpanded condition, supplying a treatment fluid under pressure to a compartment formed by the treatment sheath, to elastically expand the treatment sheath radially into a substantially conforming contact with the surrounding tissue at the treatment site, cause the treatment fluid to pass through the treatment sheath from the compartment to the surrounding tissue, and maintain the treatment sheath expanded into said contact; and
while maintaining the treatment sheath in said substantially conforming contact with the surrounding tissue at the treatment site, radially expanding the dilatation balloon within the compartment, whereby the dilatation balloon acts radially upon the surrounding tissue through the treatment sheath to effect a dilatation of the surrounding tissue.
1 Assignment
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Accused Products
Abstract
A combination dilatation and drug delivery device includes a flexible catheter, a drug delivery sheath mounted to a distal end region of the catheter and a dilatation balloon also mounted to the catheter and contained within a compartment formed by the sheath. The sheath is radially expandable by supplying a liquid therapeutic agent to the compartment under a moderate pressure. The dilatation balloon is expandable by providing a dilatation fluid to the balloon under a much higher pressure. The sheath can be formed of a highly elastic material or can be made quite thin, and in either case is mounted independently of the dilatation balloon. Thus when radially expanded, the sheath is moved into a conforming contact with surrounding vascular tissue. The conforming contact protects tissue and the therapeutic agent from exposure to blood, and more effectively confines the therapeutic agent to the intended treatment area. The sheath either is naturally porous or is provided with multiple pores, whereby the therapeutic agent perfuses through the sheath into the surrounding tissue.
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Citations
11 Claims
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1. A process for treating tissue at a treatment site within a body lumen, comprising:
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providing an elongate flexible catheter having a flexible treatment sheath mounted to a distal end region of the catheter and a dilatation balloon within the flexible treatment sheath, wherein the flexible treatment sheath is formed of an elastic material and the dilatation balloon is formed of a substantially inelastic material; intraluminally advancing the elongate flexible catheter until the flexible treatment sheath is adjacent a predetermined treatment site; while maintaining the dilatation balloon in an unexpanded condition, supplying a treatment fluid under pressure to a compartment formed by the treatment sheath, to elastically expand the treatment sheath radially into a substantially conforming contact with the surrounding tissue at the treatment site, cause the treatment fluid to pass through the treatment sheath from the compartment to the surrounding tissue, and maintain the treatment sheath expanded into said contact; and while maintaining the treatment sheath in said substantially conforming contact with the surrounding tissue at the treatment site, radially expanding the dilatation balloon within the compartment, whereby the dilatation balloon acts radially upon the surrounding tissue through the treatment sheath to effect a dilatation of the surrounding tissue. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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Specification