Atherectomy device

Abstract

An atherectomy device for removing deposits such as plaque from an interior of a vessel including an outer member and a rotatable shaft positioned for rotational movement within the outer member and fixed axially within the outer member. A tip is mounted to the distal region of the rotatable shaft and is positioned distally of the distal end of the outer member to create a gap between the proximal end of the rotatable tip and the distalmost edge of the outer member. The rotatable tip has a longitudinal axis mounted to the rotatable shaft for rotation about its longitudinal axis upon rotation of the shaft, the shaft including a guidewire lumen for receiving a guidewire to enable over the wire insertion of the device.

What is claimed is: 
     
         1 . An atherectomy device for removing deposits such as plaque from an interior of a vessel comprising:
 an outer member having a distal end;   a rotatable shaft positioned for rotational movement within the outer member and fixed axially within the outer member, the shaft having a longitudinal axis, a distal region and a distalmost edge; and   a rotatable tip having a proximal end and a distal end, the proximal end of the rotatable tip positioned distally of the distalmost edge of the outer member to create a gap between the proximal end of the rotatable tip and the distalmost edge of the outer member, the rotatable tip mounted to the distal region of the rotatable shaft and having a longitudinal axis and mounted to the rotatable shaft for rotation about its longitudinal axis upon rotation of the rotatable shaft, the rotatable shaft including a guidewire lumen for receiving a guidewire to enable over the wire insertion of the device.   
     
     
         2 . The atherectomy device of  claim 1 , further comprising an auger positioned on the rotatable shaft, the auger positioned proximally of the rotatable tip and extending along the rotatable shaft, wherein rotation of the rotatable shaft rotates the auger to move particles macerated by the rotatable tip proximally into the outer member. 
     
     
         3 . The atherectomy device of  claim 1 , wherein particles are aspirated through the outer member in the space between the rotatable shaft and an inner wall of the outer member. 
     
     
         4 . The atherectomy device of  claim 1 , wherein the rotatable tip is made of first and second materials, the first material having a first density and the second material having a second density less than the first density. 
     
     
         5 . The atherectomy device of  claim 2 , wherein particles are aspirated through the outer member in the space between the rotatable shaft and an inner wall of the outer member. 
     
     
         6 . The atherectomy device of  claim 4 , wherein the material of the first density is on one side of the rotatable tip and the material of the second density is on the other side of the rotatable tip. 
     
     
         7 . The atherectomy device of  claim 1 , wherein the rotatable tip has a first region on one side of a longitudinal axis of the shaft and a second region on an opposing side of the longitudinal axis of the rotatable shaft, and the first region has a cutout so a first amount of material in the first region is less than a second amount of material in the first region. 
     
     
         8 . The surgical apparatus of  claim 1 , wherein the rotatable tip is composed of first and second components, the first and second components radially spaced from each other. 
     
     
         9 . The surgical apparatus of  claim 8 , wherein the first component is composed of a material having a density greater than the second component. 
     
     
         10 . The surgical apparatus of  claim 10 , wherein the first component has a portion removed so it is composed of less material than the second component. 
     
     
         11 . The surgical apparatus of  claim 1 , wherein the rotatable tip is positioned proximal of the distalmost edge of the rotatable shaft. 
     
     
         12 . An atherectomy device for removing deposits such as plaque from an interior of a vessel comprising:
 an outer member having a distal end;   a rotatable shaft positioned for rotational movement within the outer member and fixed axially within the outer member, the shaft having a longitudinal axis, a distal region and a distalmost edge; and   a rotatable tip having a proximal end and a distal end, the proximal end of the rotatable tip positioned distally of the distalmost edge of the outer member to create a gap between the proximal end of the rotatable tip and the distalmost edge of the outer member, the rotatable tip mounted to the distal region of the rotatable shaft and having a longitudinal axis and mounted to the rotatable shaft for rotation about its longitudinal axis upon rotation of the rotatable shaft, the rotatable shaft including a guidewire lumen for receiving a guidewire to enable over the wire insertion of the device, the rotating tip having a first portion and a second portion, the first portion being different than the second portion.   
     
     
         13 . The atherectomy device of  claim 12 , further comprising an auger positioned on the rotatable shaft, the auger positioned proximally of the rotatable tip and extending along the rotatable shaft, wherein rotation of the rotatable shaft rotates the auger to move particles macerated by the rotatable tip proximally into the outer member. 
     
     
         14 . A method for removing deposits such as plaque from an interior of a vessel comprising the steps of:
 providing an introducer sheath having an internal diameter;   providing a deposit removal device including an outer member, a rotatable shaft and a rotating tip at a distal portion of the rotatable shaft, the rotating tip having a first portion and a second portion, the first portion being different than the second portion, the rotatable tip having a transverse cross-sectional dimension;   inserting the introducer sheath through a skin incision and into a vessel, advancing the rotatable tip adjacent the deposits to be removed; and   actuating a motor to rotate the rotatable tip at high speed to contact and remove the deposits, the tip rotating to remove deposits in a cross-sectional area greater than the transverse cross-sectional dimension of the rotatable tip.   
     
     
         15 . The method of  claim 14 , further comprising the step of aspirating deposits through a space in the outer member between the rotatable shaft and an inner wall of the outer member. 
     
     
         16 . The method of  claim 14 , wherein the rotatable shaft has a screw thread, and the step of rotating the rotatable shaft causes the external screw thread of the rotatable shaft to direct particles proximally. 
     
     
         17 . The method of  claim 14 , further comprising the step of applying a vacuum to aspirate proximally deposits removed by rotational movement of the rotating tip. 
     
     
         18 . The method of  claim 14 , further comprising the step of inserting the tip over a guidewire. 
     
     
         19 . The method of  claim 14 , wherein first and second portions differ by the first portion having a cutout to remove material from the first portion. 
     
     
         20 . The method of  claim 14 , wherein the first and second portions differ by the first portion having a first density and the second portion having a second density.