Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-12-15
2001-03-27
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06206852
ABSTRACT:
BACKGROUND
This invention generally relates to intravascular catheters used for stent delivery and percutaneous transluminal coronary angioplasty (PTCA).
PTCA is a widely used procedure for the treatment of coronary heart disease. In this procedure, a balloon on the catheter is inflated within the stenotic region of the patient's artery to open up the arterial passageway and thereby increase the blood flow through the artery.
Typically, a guiding catheter having a preshaped distal tip is first percutaneously introduced into the cardiovascular system of a patient by the Seldinger technique through the brachial or femoral arteries. The catheter is advanced until the preshaped distal tip of the guiding catheter is disposed within the aorta adjacent to the ostium of the desired coronary artery; and the distal tip of the guiding catheter is then maneuvered into the ostium. A balloon dilation catheter may then be advanced through the guiding catheter into the patient's coronary artery until the balloon on the catheter is disposed within the stenotic region of the patient's artery. The balloon is inflated to open up the arterial passageway. Generally, the inflated diameter of the balloon is approximately the same diameter as the native diameter of the body lumen being dilated so as to complete the dilation but not over expand the artery wall. After the balloon is finally deflated, blood flow resumes through the dilated artery and the dilation catheter can be removed.
A continual effort has been made in the development of intravascular catheters, to reduce the transverse dimensions or profiles of such catheters, particularly at the catheter tip. A catheter having a small or reduced profile generally has a greater ability to cross lesions and tight vasculatures. Despite much technical progress in this area, the need for intravascular catheters having greater reduced profiles at the catheter tip remains. The present invention satisfies these needs.
SUMMARY
The present invention is an intravascular balloon catheter having a small profile distal tip. In one embodiment, the distal tip generally includes a forward face with a proximal edge and a distal edge on opposite sides of the catheter shaft and a face which tapers in a distal direction from the proximal edge to the distal edge. Because the tip member is tapered from the proximal edge to the distal edge, the shape of the distal tip is similar to that of a truncated cylinder which provides the distal edge of the tip member with a low profile. The small profile and chisel-like shape of the truncated distal tip improves the overall ability of this catheter to cross any stenosis. Once the distal edge is eased through a stenosed region, sections of the catheter proximal thereto can be readily advanced across the stenosis. The truncated distal tip defines an elliptical port in the distal end thereof. The elliptical port facilitates backloading of a guidewire into the guidewire lumen of the catheter shaft, in which the proximal end of the guidewire is introduced into the distal port of the catheter, by providing a larger opening than the cylindrical port of a prior art distal tip.
The distal tip may be formed as a single unit with the catheter shaft, or alternatively, as a separate member which is secured to a distal end of the catheter shaft. The distal tip is preferably formed of a soft material, to thus avoid causing trauma and tissue damage as it is advanced through the blood vessels.
In another embodiment, the truncated distal tip further includes a first side and a second side on opposite sides of the catheter shaft longitudinal axis, the first side and the second side each tapering distally toward a center of the catheter shaft from a larger outer diameter to a smaller outer diameter, to thus form a wedge-like structure.
Another embodiment of the invention generally comprises a distal tip with a proximal end, and a distal end having an outer diameter along a first plane which is not less than an outer diameter of the proximal end of the distal tip, and with a first side and a second side on opposite sides of the catheter shaft longitudinal axis, the first side and the second side each tapering distally along a second plane toward a center of the catheter shaft from a larger outer diameter to a smaller outer diameter, to thus form a structure typical of some flat head screwdrivers but with a lumen therein.
Unlike the blunt cylindrical tip members of the catheters currently available, the profile of the catheter of the invention is much lower and this improves the ability of the catheter to cross narrowed stenosed regions and to be advanced within narrow vessels. These and other advantages will become more apparent from the following detailed description and accompanying exemplary drawings.
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Advanced Cardiovascular Systems Inc.
Heller Ehrman White & McAuliffe LLP
Mendez Manuel
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