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 method of removing a specimen of breast tissue that is cut from surrounding breast tissue, comprising: 
 a. providing a device that includes a shaft and a tissue collection element which is coupled to the shaft, which has at least one thin flexible component and which is movable between a retracted position and an expanded position;    b. introducing the device into the breast tissue with the tissue collection element in the retracted position;    c. expanding the tissue collection element to the expanded position after the introducing step;    d. moving the tissue collection element to capture the cut specimen;    e. encapsulating the cut specimen with the at least one thin flexible component while maintaining the cut specimen intact and isolating the encapsulated specimen from contact with the surrounding breast tissue and returning the tissue collection element to the retracted position while maintaining the cut specimen intact and encapsulated; and    f. removing the device from the breast tissue while the specimen remains encapsulated within the at least one thin flexible component of the retracted tissue collection element.    
   
   
       41 . The method of  claim 40 , wherein the encapsulating step is carried out with the at least one thin flexible component forms a container.  
   
   
       42 . The method of  claim 41 , wherein the container is configured to selectively open to capture the cut specimen and close to encapsulate the cut specimen as the tissue collection element bows away from and back toward the shaft, respectively.  
   
   
       43 . The method of  claim 40 , wherein the moving step includes rotating the shaft.  
   
   
       44 . The method of  claim 40 , wherein the moving step is carried out with the tissue collection element moving along an arc.  
   
   
       45 . The method of  claim 40 , wherein the encapsulating step is carried out with the tissue collection element expanding to a size at least equal to the size of the cut specimen.  
   
   
       46 . The method of  claim 40 , wherein the shaft defines a longitudinal axis and wherein: 
 g. the introducing step includes positioning the shaft along side of the cut specimen; and    h. the moving step includes rotating the shaft about the longitudinal axis while moving the tissue collection element from the retracted position to the expanded and back to the retracted position to capture and encapsulate the cut specimen as the shaft rotates.