Apparatus and methods for removing obstructive material from body lumens

An apparatus for removing material within a body lumen, comprising:

• an elongate tubular member including a proximal end, a distal end sized for introduction into a body lumen, and an aspiration lumen extending between the proximal and distal ends and that is defined by an aspiration lumen wall, the distal end having a flexibility to facilitate advancement through tortuous anatomy;
• a cutting head disposed within the aspiration lumen adjacent the distal end, the cutting head being reciprocable axially between distal and proximal positions within the aspiration lumen for macerating material being aspirated into the aspiration lumen, wherein the cutting head comprises a plurality of teeth and is capable of extending at least partially from the distal end of the elongate tubular member;
• a drive shaft extending from the cutting head through the aspiration lumen to the proximal end of the tubular member;
• a control system coupled to the cutting head that reciprocates the cutting head axially between the distal and proximal positions, wherein the control system includes a motor coupled to the drive shaft for reciprocating the drive shaft axially through the aspiration lumen, thereby reciprocating the cutting head axially within the aspiration lumen;
• a flow restoration device deployable distally beyond the distal end of the tubular member, the flow restoration device comprising a shaft slidably received within the tubular member and an expandable member on a distal tip thereof that is expandable to a size larger than the distal end of the tubular member for engaging a wall of a body lumen to direct material within the body lumen towards the distal end of the tubular member when the flow restoration device is retracted proximally towards the distal end after deployment;
• and
• a clutch device that is free to pass over the shaft of the flow restoration device during an outstroke of the cutting head and engages the shaft of the flow restoration device during an instroke of the cutting head such that each stroke of the cutting head pulls the expandable member proximally a predetermined distance.