Excisional biopsy devices and methods

Abstract

An excisional biopsy device includes a tubular member having a window near a distal tip thereof; a cutting tool, a distal end of the cutting tool being attached near the distal tip of the tubular member, at least a distal portion of the cutting tool being configured to selectively bow out of the window and to retract within the window; and a tissue collection device externally attached at least to the tubular member, the tissue collection device collecting tissue excised by the cutting tool as the biopsy device is rotated and the cutting tool is bowed.

1 . An excisional biopsy device, comprising:
 a tubular member having a window near a distal tip thereof;   a cutting tool, a distal end of the cutting tool being attached near the distal tip of the tubular member, at least a distal portion of the cutting tool being configured to selectively bow out of the window and to retract within the window; and   a tissue collection device externally attached at least to the tubular member, the tissue collection device collecting tissue severed by the cutting tool as the biopsy device is rotated and the cutting tool is bowed.   
     
     
         2 . The excisional biopsy device of  claim 1 , wherein the distal portion of the cutting tool comprises a thin ribbon sharpened on a leading edge thereof. 
     
     
         3 . The excisional biopsy device of  claim 2 , wherein the leading edge of the thin ribbon is serrated. 
     
     
         4 . The excisional biopsy device of  claim 1 , wherein the tubular member comprises an internal guide allowing a proximal portion of the cutting tool to slide therein when a proximal end of the cutting tool is pushed in a distal direction or pulled in a proximal direction. 
     
     
         5 . The excisional biopsy device of  claim 1 , wherein the cutting tool further comprises:
 an interior lumen; and   a plurality of through holes in the distal portion thereof, the through holes being in fluid communication with the interior lumen.   
     
     
         6 . The excisional biopsy device of  claim 1 , wherein the tissue collection device comprises a bag within which the severed tissue is collected. 
     
     
         7 . The excisional biopsy device of  claim 6 , wherein an opening of the bag is at least co-extensive with the window in the tubular member. 
     
     
         8 . The excisional biopsy device of  claim 1 , wherein the tissue collection device is configured to open and to close as the cutting tool is selectively bowed and retracted, respectively. 
     
     
         9 . The excisional biopsy device of  claim 8 , wherein the tissue collection device comprises a bag attached to the tubular member and to a trailing edge of the distal portion of the cutting tool, the bag opening and closing as the cutting tool is bowed and retracted, respectively. 
     
     
         10 . The excisional biopsy device of  claim 1 , further comprising an ultrasound sensor mounted within the distal portion of the tubular member, the ultrasound sensor being disposed within the tubular member so as to image tissue about to be cut by the cutting tool as the biopsy device is rotated. 
     
     
         11 . The excisional biopsy device of  claim 10 , wherein the ultrasound sensor is electrically connected to at least one data processing and display device to allow one of a real time and near real time graphical representation of the tissue to be cut. 
     
     
         12 . The excisional biopsy device of  claim 1 , wherein the distal portion of the cutting tool is electrically connected to an RF power source. 
     
     
         13 . The excisional biopsy device of  claim 12 , wherein the distal portion of the cutting tool comprises a thin wire. 
     
     
         14 . An invasive interventional device for soft biological tissue, comprising:
 a rotatable tubular member having a distal tip adapted to penetrate the tissue;   a work element disposed near the distal tip of the tubular member, the work element acting upon the tissue coming into contact therewith as the tubular member rotates;   an ultrasound transducer disposed near the distal tip of the tubular member and away from the work element, so that the transducer sweeps a plane within the tissue ahead of the work element as the tubular member rotates; and   means for controlling an operation of the work element based upon information gathered from the ultrasound transducer.   
     
     
         15 . The device of  claim 14 , wherein the ultrasound transducer is tuned within a range from about 7.5 MHz to about 20 MHz. 
     
     
         16 . The device of  claim 14 , wherein the ultrasound transducer is disposed within the tubular member at an angle α relative to the work element, the angle α being no smaller than that necessary to effectively control the operation of the work element in response to the information gathered from the transducer as the tubular member rotates. 
     
     
         17 . The device of  claim 16 , wherein the angle α is less than about 180 degrees. 
     
     
         18 . The device of  claim 14 , wherein the work element comprises at least one device selected from the group consisting of: an abrasive device, a reciprocating cutting device, a bowing cutting device, an electrosurgical device, a laser device and a vibrating device. 
     
     
         19 . The device of  claim 14 , wherein the ultrasonic transducer is connected to at least one data processing and display device to allow an operator of the device to ascertain a structure of the tissue and to control the operation of the work element before the tissue comes into contact with the work element as the device rotates. 
     
     
         20 . The device of  claim 14 , wherein the work element comprises a cutting tool, a distal end of the cutting tool being attached near the distal tip of the tubular member, at least a distal portion of the cutting tool being configured to selectively bow out of a window in the tubular member and to retract within the window. 
     
     
         21 - 49 . (canceled)