Importance

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Abstract

A refolding tool, tool system, and method of use for refolding the flaps of the inflatable balloon of a medical balloon catheter, particularly a dilatation balloon catheter for use in a percutaneous transluminal coronary angioplasty (PTCA) procedure, after it has been inflated and deflated or released from a balloon protector. The refolding tool is formed with a refolding tool body having a first tool end surface and preferably with a plurality of second tool end surfaces and a like plurality of refolding lumens extending from the first tool end surface to a respective one of the second tool end surfaces. Each refolding lumen has a unique refolding lumen length and lumen diameter exceeding the catheter body diameter. An initial refolding lumen of the refolding tool has an initial refolding lumen diameter that exceeds the specified refolded diameter and is sized to accommodate advancement of the balloon through the initial refolding lumen to refold the balloon to an initial refolded balloon diameter exceeding the specified refolded diameter. A final refolding lumen of the refolding tool has a final refolding lumen diameter that is smaller in diameter than the initial refolding lumen diameter and is sized to refold the initial refolded balloon diameter to the specified refolded diameter upon advancement of the balloon through the final refolding lumen to refold the balloon to substantially the specified refolded diameter. For balloon catheters having a balloon catheter lumen, the tool system comprises a support stylet that is advanced from the balloon catheter distal end through the catheter distal segment to stiffen the catheter distal segment during the refolding procedure.

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First Claim