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. An excisional biopsy method for soft tissue includes the steps of inserting a generally tubular member into the tissue, the tubular member including a cutting tool adapted to selectively bow away from the tubular member and an external tissue collection device near a distal tip of the tubular member; rotating the tubular member; selectively varying a degree of bowing of the cutting tool; collecting tissue severed by the cutting tool in the tissue collection device; and retracting the tubular member from the soft tissue. The tubular member may include an imaging transducer and the method may include the step of displaying information received from the transducer on a display device and the step of varying the degree of bowing of the cutting tool based upon the displayed information from the imaging transducer. Alternatively, the imaging transducer may be disposed within a removable transducer core adapted to fit within the tubular member.

1 - 35 . (canceled) 
     
     
         36 . An excisional biopsy device, comprising:
 a tubular member having a first and a second window near a distal tip thereof;   a cutting tool configured to selectively bow out of the first window and to retract within the first window; and   a removable transducer core, the transducer core including an active transducer element configured to face out of the second window when the removable transducer core is fitted within the tubular member.   
     
     
         37 . The device of  claim 36 , wherein the removable core is adapted to snap fit within the tubular member. 
     
     
         38 . The device of  claim 36 , wherein the active transducer element includes an ultrasound transducer. 
     
     
         39 . The device of  claim 36 , wherein the removable transducer core comprises a tapered distal tip configured to readily penetrate soft tissue. 
     
     
         40 . The device of  claim 36 , further comprising an external tissue collection device attached at least to the cutting tool. 
     
     
         41 . The device of  claim 40 , wherein the tubular member further comprises a recessed section adjacent a trailing edge of the cutting tool, the recessed section being adapted to receive the external tissue collection device. 
     
     
         42 . The device of  claim 36 , further comprising an expandable sheath, the expandable sheath being adapted to receive the removable transducer core and the tubular member. 
     
     
         43 . Method of excising a lesion from soft biological tissue using an excisional biopsy system including a generally tubular member having a cutting tool, a removable transducer core adapted to fit within the tubular member and an expandable sheath, comprising the steps of:
 fitting the transducer core through the expandable sheath,   inserting the transducer and sheath though an incision in the tissue;   imaging a target site within the tissue by energizing the transducer core,   removing the transducer core from sheath while leaving the sheath in place within the tissue;   securing the core within the generally tubular member so the core faces outwardly from the tubular member;   sliding the tubular member through the expandable sheath until the cutting tool is positioned adjacent the lesion;   cutting the lesion with the cutting tool; and   retracting at least the tubular member from the incision.   
     
     
         44 . The method of  claim 43 , further comprising the step of stabilizing the breast in one of an uncompressed and a slightly expanded state prior to the inserting step. 
     
     
         45 . The method of  claim 43 , wherein the sheath remains within the tissue after the retracting step and wherein the method further comprises the step of:
 re-inserting the transducer core within the sheath and imaging the target site to insure that the lesion has been excised.   
     
     
         46 . The method of  claim 43 , further comprising the step of collecting the cut lesion within an external tissue collection device secured to the tubular member. 
     
     
         47 . The method of  claim 43 , wherein both the tubular member and the sheath are retracted from the incision. 
     
     
         48 . An excisional biopsy device, comprising:
 a single use disposable tubular member having a window near a distal tip thereof, the tubular member including 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 single use disposable 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.   
     
     
         49 . An excisional biopsy device, comprising:
 a single use disposable tubular member having a first and a second window near a distal tip thereof, the tubular member including a cutting tool configured to selectively bow out of the first window and to retract within the first window; and   a removable transducer core, the transducer core including an active transducer element configured to face out of the second window when the removable transducer core is fitted within the tubular member.