Rotational Atherectomy Device with Distal Protection Capability and Method of Use

Abstract

A rotational device for removing a stenotic lesion from within a vessel of a patient is disclosed. The device comprises a flexible hollow drive shaft having a distal end insertable into the vessel and an abrasive element located on the drive shaft proximal to the distal end of the drive shaft to abrade a stenotic lesion when the drive shaft rotates. The hollow drive shaft defines a lumen for fluid supplied into the drive shaft to flow in an antegrade direction along the lumen and into the vessel from the drive shaft distal to the abrasive element so that the fluid entering the vessel flows in a retrograde direction over the abrasive element and the drive shaft to entrain debris abraded by the abrasive element for removal of said debris from the patient.

1 . (canceled) 
     
     
         2 . A system for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient, the system comprising:
 an elongate sheath defining a sheath lumen therethrough and an inflatable element surrounding a distal end portion of the sheath; and   a rotational atherectomy device slidable through the elongate drive shaft sheath toward stenotic lesion material in a blood vessel, comprising:
 an elongate flexible drive shaft comprising a torque-transmitting coil that defines a central lumen and a longitudinal axis of rotational atherectomy device, the drive shaft configured to be at least partially disposed within the sheath lumen when the system is used for performing the rotational atherectomy; 
 an abrasive element that is mounted to a distal region of the drive shaft, the abrasive element including an abrasive outer surface; 
 at least a distal stability element that is fixed to the distal region of the drive shaft, that has a center of mass that is aligned with the longitudinal axis, and that has an outer surface less abrasive than the abrasive outer surface of the abrasive element, the distal stability element being distally spaced apart from the abrasive element, and both the distal stability element and the abrasive element rotate together about the longitudinal axis in response to rotation of the torque-transmitting coil of the drive shaft; and 
 a fluid impermeable membrane that surrounds at least an exterior circumferential region of the torque-transmitting coil extending distally beyond the abrasive element. 
   
     
     
         3 . The system of  claim 2 , wherein a maximum outer diameter of the distal stability element is smaller than a maximum outer diameter of the abrasive element. 
     
     
         4 . The system of  claim 3 , wherein the distal stability element is generally round and surrounds the torque-transmitting coil of the drive shaft. 
     
     
         5 . The system of  claim 3 , wherein the distal stability element comprises a solid body surrounding the torque-transmitting coil of the drive shaft. 
     
     
         6 . The system of  claim 2 , wherein the abrasive element has an ovular cross-sectional shape. 
     
     
         7 . The system of  claim 2 , further comprising a guidewire configured to slidably withdraw into the central lumen of the drive shaft. 
     
     
         8 . The system of  claim 7 , wherein the drive shaft defines an opening of the central lumen at the distal end of the drive shaft. 
     
     
         9 . The system of  claim 2 , wherein the abrasive element has a circular cross-section in a plane perpendicular to the longitudinal axis 
     
     
         10 . The system of  claim 9 , wherein the abrasive element is spherical. 
     
     
         11 . The system of  claim 2 , wherein the abrasive element is located around the torque-transmitting coil of the drive shaft. 
     
     
         12 . The system of  claim 2 , wherein the abrasive element is spaced away from a distal end of the drive shaft by a distance of not less than about 3 mm. 
     
     
         13 . The system of  claim 2 , wherein the sheath defines an inflation lumen extending along a length of the sheath for supplying an inflation medium to the inflatable element. 
     
     
         14 . The system of  claim 13 , wherein the sheath includes a radiopaque marker near the distal end portion of the sheath. 
     
     
         15 . The system of  claim 2 , further comprising a proximal stability element that is fixed to the distal region of the drive shaft. 
     
     
         16 . The system of  claim 15 , wherein the proximal stability element has a center of mass aligned with the longitudinal axis, and the proximal stability element is proximally spaced apart from the abrasive element. 
     
     
         17 . The system of  claim 15 , wherein the distal and proximal stability elements are equally spaced apart from the abrasive element. 
     
     
         18 . The system of  claim 2 , wherein the distal stability element is a fluid-inflatable element. 
     
     
         19 . The system of  claim 2 , wherein a center of mass of the abrasive element is aligned with the longitudinal axis of the drive shaft. 
     
     
         20 . The system of  claim 2 , wherein the fluid impermeable membrane surrounds the exterior of the distal region of the drive shaft.