Eccentric abrading head for high-speed rotational atherectomy devices

A high-speed rotational atherectomy device for opening a stenosis in an artery having a given diameter, comprising:

• a guide wire having a maximum diameter less than the diameter of the artery;
• a flexible elongated, rotatable drive shaft advanceable over the guide wire, the drive shaft having a rotational axis;
• and
• at least one half-crown eccentric abrading head attached to the drive shaft, the abrading head comprising proximal and intermediate portions, wherein the proximal portion comprises a proximal outer surface and the intermediate portion comprises an intermediate outer surface, the proximal outer surface having diameters that increase distally, the distal outer surface having diameters that decrease distally, and the intermediate outer surface being cylindrical, wherein at least the intermediate outer surface comprise tissue removal sections and wherein the abrading head defines a drive shaft lumen therethrough and a hollow cavity, the drive shaft at least partially traversing the drive shaft lumen.

A method for opening a stenosis in an artery having a given diameter, comprising:

• providing a guide wire having a maximum diameter less than the diameter of the artery;
• advancing the guide wire into the artery to a position proximal to the stenosis;
• providing a flexible elongated, rotatable drive shaft advanceable over the guide wire, the drive shaft having a rotational axis;
• providing at least one eccentric abrading head attached to the drive shaft, the abrading head comprising at least proximal and intermediate portions, wherein the proximal portion comprises a proximal outer surface and the intermediate portion comprises an intermediate outer surface, the proximal outer surface having diameters that increase distally, the distal outer surface having diameters that decrease distally, and the intermediate outer surface being cylindrical, wherein at least the intermediate outer surface comprise tissue removal sections and wherein the abrading head defines a drive shaft lumen therethrough and a hollow cavity, the drive shaft at least partially traversing the drive shaft lumen;
• advancing the drive shaft over the guide wire wherein the at least one eccentric abrading head is adjacent the stenosis;
• rotating the drive shaft and attached at least one eccentric abrading head at a speed between 20,000 and 200,000 rpm;
• creating an orbital path traversed by the at least one eccentric abrading head;
• and
• abrading the stenosis with the at least one eccentric abrading head.