Single-lumen balloon catheter having a directional valve

Surgery – Instruments – Internal pressure applicator

Patent

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Details

604 96, 604249, 128772, A61M 2900

Patent

active

056834101

DESCRIPTION:

BRIEF SUMMARY
FIELD OF THE INVENTION

This invention is a single-lumen balloon catheter having a valve seat on the distal end of the catheter, distal of the balloon, which may be operated by a control wire having a valve plug disposed on the wire. The valve seat may be engaged by the valve plug from either direction, depending on the installation of the control wire. In either event, if the valve plug is installed distally of the valve seat in the catheter lumen, the valve is closed by pulling on the control wire (or moving the control wire in a proximal direction) and introducing fluid through the catheter lumen through the balloon. Alternatively, the guidewire, with its integral valve plug, may be introduced from the proximal end of the catheter and may traverse the body of the balloon to engage the valve seat in the distal end of the catheter. Pushing on the control wire will seat the valve, allowing the introduction of fluid through the catheter lumen to inflate the balloon. The latter arrangement allows the control wire to be interchanged with other guidewires a physician may wish to use. The balloon provided for in this invention is of a single length and does not change its axial length as it is inflated.


BACKGROUND OF THE INVENTION

Angioplasty is an excellent method for treating a wide variety of vascular diseases. In particular, it has been used extensively for opening stenoses in coronary arteries. The process has been increasingly used for treatment of stenosis in other parts of the vascular system.
One of the more well known and widely practiced forms of angioplasty makes use of a dilatation catheter which has an inflatable balloon at is distal end. Using fluoroscopy, the physician guides the catheter through the vascular system until the balloon is properly positioned. By applying a fluid through the separate inflation lumen, the balloon is inflated. The balloon's inflation causes the artery to stretch and presses the lesion or stenose into the artery wall, thereby re-establishing after deflation of the balloon, increased blood flow through the artery.
In order to treat very tight stenoses, i.e., those having small openings, increasingly small catheter diameters are desirable. Significantly more flexible catheters are also desired in that otherwise very tight areas of stenosis will not be approachable. Although flexible and narrow of diameter, a good catheter must also be easily introduced and easily advanced through the tortuous path of the vascular system.
There are a variety of dilatation catheter types. Many use multiple lumens. For instance, a catheter may use a separate guidewire lumen so that a guidewire can be used to establish the path to the stenosis. The catheter may then be fed over the guidewire until the balloon is positioned over the stenosis. The catheter obviously has a separate lumen to allow introduction of and removal of fluid for the balloon.
Other catheter designs include those which act as their own guidewire, thereby eliminating the need for a separate guidewire lumen. Elimination of the need for the separate lumen means that the profile of the catheter can be somewhat smaller. Typical of such integral designs are U.S. Pat. No. 4,606,247, to Fogarty et al., which shows a catheter having an evertible balloon at is distal tip. The distal tip of the catheter is placed near the stenosis to be treated. The balloon is extended beyond the distal tip to a position within the stenosis and then inflated to press the lesion back into the wall of the vessel. The balloon contains a passageway in the middle having a plug of some elastomeric material through which a guidewire may be placed. The plug retains the pressure of the fluid on the balloon, whether the guidewire is present or not.
Another "over-the-wire" catheter is shown in U.S. Pat. No. 5,085,636, to Burns. The Burns device utilizes a balloon having a port for introducing fluid into the balloon and simultaneous device for not allowing fluid to pass through the catheter when a guidewire is present in the vicinity of the balloon. The flu

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