Breast biopsy system and methods

Abstract

An apparatus and method are provided for precisely isolating a target lesion in a patient's body tissue, resulting in a high likelihood of “clean” margins about the lesion when it is removed for diagnosis and/or therapy. This approach advantageously will often result in the ability to both diagnose and treat a malignant lesion with only a single percutaneous procedure, with no follow-up percutaneous or surgical procedure required, while minimizing the risk of migration of possibly cancerous cells from the lesion to surrounding tissue or the bloodstream. In particular, the apparatus comprises a biopsy instrument having a distal end adapted for entry into the patient's body, a longitudinal shaft, and a cutting element disposed along the shaft. The cutting element is actuatable between a radially retracted position and a radially extended position. Advantageously, the instrument is rotatable about its axis in the radially extended position to isolate a desired tissue specimen from surrounding tissue by defining a peripheral margin about the tissue specimen. Once the tissue specimen is isolated, it may be segmented by further manipulation of the cutting element, after which the tissue segments are preferably individually removed from the patient's body through a cannula or the like. Alternatively, the specimen may be encapsulated and removed as an intact piece.

1 . A biopsy instrument for retrieving body tissue, having a longitudinal axis and comprising: 
 a distal end adapted for entry into a patient's body; and    a cutting element disposed on said instrument, said cutting element being actuatable between a radially retracted position and a radially extended position, relative to said axis, and being movable in said radially extended position to isolate a desired tissue specimen from surrounding tissue by defining a peripheral margin about said tissue specimen.    
   
   
       2 - 39 . (canceled)  
   
   
       40 . An excisional biopsy method for soft tissue, comprising: 
 a. inserting a generally tubular member into the tissue which has a cutting tool adapted to selectively bow away from the tubular member and which has a tissue collection device near a distal tip of the tubular member;    b. rotating the tubular member;    c. selectively varying a degree of bowing of the cutting tool;    d. collecting tissue severed by the cutting tool in the tissue collection device; and    e. retracting the tubular member from the soft tissue.    
   
   
       41 . The method of  claim 40 , wherein the rotating step is carried out by manually rotating the tubular member.  
   
   
       42 . The method of  claim 40 , wherein the extension of the cutting tool is controlled by selectively and manually pushing and retracting a proximal end of the cutting tool in the distal and proximal directions, respectively.