Method of treating vulnerable plaque

Surgery – Instruments – Internal pressure applicator

Reexamination Certificate

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Reexamination Certificate

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06972024

ABSTRACT:
A method of treating vulnerable plaque comprising intentionally damaging or rupturing the vulnerable plaque using a wingless balloon which is inflated from a wingless unexpanded diameter to a limited expanded diameter. This process produces significant increase in ECM synthesis at the site of the damage or rupture. As a result, the method strengthens the vulnerable plaque while minimizing or avoiding damage to the surrounding wall of the body lumen or damaging a stable plaque mistakenly believed to be a vulnerable plaque. The method of the invention is particularly useful in treating a fibroatheroma type of vulnerable plaque. In one embodiment, the balloon is self-limiting such that it expands compliantly at initial inflation pressures, and above nominal pressure it expands noncompliantly. In an alternative embodiment, the balloon is inflated using a diameter-limiting device, such as a device which limits the inflation pressure or the volume of inflation fluid in the balloon.

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Schwartz et al., “Restenosis and the Proportional Neointimal Response to Coronary Artery Injury: Results in a Porcine Model” JACC 19(2):267-274 (1992).

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