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 . A breast tissue treatment device, comprising: 
 a shaft having a window near a distal tip thereof; 
 a. a tissue cutting tool, the cutting tool being attached near the distal tip of the shaft, the cutting tool being configured to selectively bow out of the window and to retract within the window; and  
 b. a tissue collection and isolation device, the tissue collection and isolation device being configured to collect tissue cut by the tissue cutting tool and to physically isolate the collected tissue from a surrounding tissue.  
   
   
   
       41 . The device of  claim 1 , wherein the tissue cutting tool is configured to be energized by an RF energy source.  
   
   
       42 . The device of  claim 40 , wherein the tissue collection and isolation device is configured to selectively open and close.  
   
   
       43 . The device of  claim 40 , wherein the tissue collection and isolation device is configured to selectively bow out away from the shaft and to retract back toward the shaft.  
   
   
       44 . The device of  claim 43 , wherein the tissue collection and isolation device is further configured to lay substantially flat against the shaft when in a retracted position.  
   
   
       45 . The device of  claim 40 , wherein the shaft includes a first portion that is configured to remain outside the tissue and a second portion that is configured to penetrate the tissue, the first portion having a greater diameter than the second portion.  
   
   
       46 . The device of  claim 40 , wherein the tissue collection device includes at least one thin flexible member and is configured to surround collected tissue.  
   
   
       47 . A method of retrieving a specimen from a mass of tissue, including: 
 a. inserting an instrument that includes a cutting clement and a tissue collection and isolation element into the mass of tissue, the cutting element being configured to cut a specimen from a mass of tissue and the tissue collection and isolation element being configured to collect the specimen and to physically isolate the specimen from the mass of tissue;    b. cutting the specimen; and    c. collecting the cut specimen and physically isolating the specimen from the mass of tissue.    
   
   
       48 . The method of  claim 47 , wherein the collecting and isolating includes: 
 a. sequentially extending the tissue collection and isolation element to collect the specimen; and    b. retracting the tissue collection and isolation element to isolate the collected specimen from the mass of issue.    
   
   
       49 . The method of  claim 47  wherein the tissue isolation includes drawing the isolation element around the specimen.  
   
   
       50 . The method of  claim 49 , wherein the specimen includes a lesion and wherein the cutting step cuts a margin of healthy tissue around the specimen.  
   
   
       51 . The method of  claim 49 , wherein the cutting and collecting and isolating preserves the collected and isolated specimen.  
   
   
       52 . A tissue treatment device, comprising: 
 a. a shaft defining a proximal and a distal end;    b. a tissue treatment assembly attached near the distal end of the shaft and including a first tool configured to cut tissue and a second tool configured to collect the cut tissue and to isolate the collected tissue from a surrounding tissue, the first tool being configured to selectively extend away from the shaft and to retract toward the shaft, the second tool being configured to open so as to collect the cut tissue and close so as to isolate the collected tissue as the first tool is selectively extended and retracted, respectively.    
   
   
       53 . The device of  claim 52 , wherein the first tool defines a leading edge adapted to cut tissue and a trailing edge.  
   
   
       54 . The device of  claim 52 , wherein the tissue includes breast tissue.  
   
   
       55 . The device of  claim 52 , wherein the second tool is configured to lay substantially flat against an outer surface of the shaft when the first tool is fully retracted.  
   
   
       56 . The device of  claim 52 , wherein the first tool is configured to be energized by RF energy.