Tissue accessing and anchoring device and method

Abstract

The invention provides systems, methods and a node accessing and anchoring device, comprising an elongated shaft, a tissue cutting member, at least one anchoring element extending from a position at or near the distal end of the shaft; and a radiation detector. The radiation detector is effective to locate and identify sentinel lymph nodes following injection of radioactive material into a primary lesion site within a patient. The tissue cutting member, which may be activated with radio frequency energy, is effective to allow access of the elongated shaft to a sentinel lymph node. The anchoring elements are effective to anchor the device to or adjacent a sentinel lymph node accessed by the device. Anchoring elements may assume radially, longitudinally, or mixed radially and longitudinally curved or coiled configurations when deployed.

1 . A tissue access and anchoring device, comprising: 
 a. an elongated shaft having a distal end and a proximal end;    b. a tissue cutting member at the end of the distal shaft; and    c. at least one anchoring element extending from a position at or near the distal end of the shaft:    
   
   
       2 - 65 . (canceled)  
   
   
       66 . A method of positioning a needle in a patient's breast for a medical procedure, comprising the steps of: 
 providing a needle having at least one movable indicator for indicating an angular orientation when viewed along a longitudinal axis of the needle, the needle having a distal portion and a proximal portion;    positioning the distal portion in a patient's breast with the proximal portion remaining outside the breast,    moving the indicator to a position which provides an indication of a selected angular orientation relative to the longitudinal axis to move the indicator to a position which angularly bounds a tissue area to be removed from the breast, and    performing a medical procedure using information from the selected angular orientation.    
   
   
       67 . The method of  claim 66 , wherein: 
 the performing step includes the step of removing breast tissue.    
   
   
       68 . A method of positioning a needle in a patient's breast for a medical procedure, comprising the steps of: 
 providing a needle at least one movable indicator for indicating an: angular orientation when viewed along a longitudinal axis of the needle, the needle having a distal portion that includes at least one anchoring element and a proximal portion;    positioning the distal portion in a patient's breast with the proximal portion remaining outside the breast,    moving the indicator to a position which provides an indication of a selected angular orientation relative to the longitudinal axis, the moving step being carried out by moving the at least one anchoring element, the at least one anchoring element being displaced angularly with respect to the longitudinal axis, and    performing a medical procedure using information from the selected angular orientation.    
   
   
       69 . The method of  claim 68 , wherein: 
 the performing step includes the step of removing breast tissue.    
   
   
       70 . The method of  claim 68 , wherein: 
 the moving step is carried out with the at least one anchoring element being a thin, elongate element which pierces the breast tissue.    
   
   
       71 . The method of  claim 68 , wherein: 
 the moving step is carried out with the at least one anchoring element being a wire.    
   
   
       72 . The method of  claim 70 , wherein: 
 the providing step is carried out with the needle having a shaft; and    the moving step is carried out with the anchoring element extending through a slot in the shaft.    
   
   
       73 . The method of  claim 70 , wherein: 
 the performing step includes the step of removing breast tissue.    
   
   
       74 . A method of positioning a needle in a patient's breast for a medical procedure, comprising the steps of: 
 providing a needle having at least one movable indicator for indicating an angular orientation when viewed along a longitudinal axis of the needle, the needle having a distal portion and a proximal portion;    positioning the distal portion in a patient's' breast with the proximal portion remaining outside the breast,    moving the indicator to a position which provides an indication of a selected angular orientation relative to the longitudinal axis by selecting at least two different angular positions when viewed along the longitudinal axis of the needle, and    performing a medical procedure using information from the selected angular orientation.    
   
   
       75 . The method of  claim 74 , wherein: 
 the performing step includes the step of removing breast tissue.    
   
   
       76 . The method of  claim 74 , wherein: 
 the providing is carried out with the needle including at least one anchoring element, and    the moving step is carried out by moving the at least one anchoring element, the anchoring element being displaced angularly with respect to the longitudinal axis during the moving step.    
   
   
       77 . The method of  claim 76 , wherein: 
 the moving step is carried out with the at least one anchoring element being a thin, elongate element which pierces the breast tissue.    
   
   
       78 . The method of  claim 76 , wherein: 
 the moving step is earned out with the at least one anchoring element being a wire.    
   
   
       79 . The method of  claim 77 , wherein: 
 the providing step is carried out with the needle having a shaft; and    the moving step is carried out with the element extending through a slot in the shaft.    
   
   
       80 . A method of positioning a needle in a patient's breast for a medical procedure, comprising the steps of: 
 providing a needle having at least one movable indicator for indicating an angular orientation when viewed along a longitudinal axis of the needle, the needle having a distal portion and a proximal portion;    positioning the distal portion in a patient's breast with the proximal portion remaining outside the breast;    moving the indicator to a position which provides an indication of a selected angular orientation relative to the longitudinal axis and repeating the moving step at least once to indicate two different angular orientations relative to the longitudinal axis; and    performing a medical procedure using information from the selected angular orientation.    
   
   
       81 . The method of  claim 80 , wherein: 
 the providing is can-fed out with the needle including at least one anchoring element, and    the moving step is carried out by moving the at least one anchoring element, the anchoring element being displaced angularly with respect to the longitudinal axis during the moving step.    
   
   
       82 . The method of  claim 81 , wherein: 
 the moving step is carried out with the at least one anchoring element being a thin, elongate element which pierces the breast tissue.    
   
   
       83 . The method of  claim 81 , wherein: 
 the moving step is carried out with the at least one anchoring element being a wire.    
   
   
       84 . The method of  claim 82 , wherein: 
 the providing step is carried out with the needle having a shaft; and    the moving step is carried out with the element extending through a slot in the shaft.    
   
   
       85 . A needle for introduction into a patient's breast comprising: 
 an elongate shaft having a longitudinal axis; and    a first indicator for indicating an angular orientation when viewed along the longitudinal axis of the shaft. the first indicator being movable by the user to a selected angular orientation and being coupled to an anchoring element, the anchoring element being displaced angularly with respect to the longitudinal axis when the first indicator is moved by the user.    
   
   
       86 . The needle of  claim 85 , wherein: 
 the first indicator is moved to a position to provide angular information regarding a tissue area to be removed from the breast.    
   
   
       87 . The needle of  claim 85 , wherein: 
 the anchoring element is a thin, elongate element which pierces the breast tissue    
   
   
       88 . The needle of  claim 85 , wherein: 
 the anchoring element is a wire.    
   
   
       89 . The needle of  claim 88 , wherein: 
 the wire extending through a slot in the shaft.    
   
   
       90 . A needle for introduction into a patient's breast, comprising: 
 an elongate shaft having a longitudinal axis;    a first indicator for indicating an angular orientation when viewed along the longitudinal axis of the shaft, the first indicator being movable by the user to a selected angular orientation, and    a second indicator for indicating another angular orientation when viewed along the longitudinal axis of the shaft.    
   
   
       91 . The needle of  claim 90 , wherein: 
 the first and second indicators are moved to positions to provide angular information regarding a tissue area to be removed from the breast.    
   
   
       92 . The needle of  claim 90 , wherein: 
 the first indicator is coupled to an anchoring element, the anchoring element being displaced angularly with respect to the longitudinal axis when the first indicator is moved by the user.    
   
   
       93 . The needle of  claim 92 , wherein: 
 the anchoring element is a thin, elongate element which pierces the breast tissue.    
   
   
       94 . The needle of  claim 92 , wherein: 
 the anchoring element is a wire.    
   
   
       95 . The needle of  claim 94 , wherein: 
 the wire extending through a slot in the shaft.    
   
   
       96 . A method of excising breast tissue, comprising the steps of: 
 providing a guide element and a cutting device, the cutting device having a deployable cutting element mounted on a shaft, the cutting device also having a tissue collection element;    introducing the guide element into a patient's breast;    advancing the cutting device into the patient's breast, the cutting device being slidably coupled to the guide element so that the guide element guides the cutting device as the cutting device is advanced into the patient's breast;    deploying a cutting element on the cutting device after the advancing step, the cutting element moving from a collapsed position to an expanded position, the cutting element bowing outwardly from the shaft when being deployed;    rotating the shaft so that the cutting element severs breast tissue, the severed breast tissue entering the tissue collection element which trails the cutting element as the cutting element moves through the breast tissue when the shaft is rotated; and    removing the breast tissue which has been severed by the cutting element and is contained within the tissue collection element.    
   
   
       97 . The method of  claim 96 , wherein: 
 the providing step is carried out with the guide element being a needle; and    the advancing step being carried out with the cutting device being advanced over the needle.    
   
   
       98 . The method of  claim 96 , wherein: 
 the rotating step is carried out with the shaft rotating less than 180 degrees relative to the guide element.    
   
   
       99 . The method of  claim 96 , wherein: 
 the providing step is carried out with the guide element having an indicator for a desired depth of penetration of the cutting device during the advancing step.    
   
   
       100 . The method of  claim 96 , wherein: 
 the removing step is carried out with the tissue collection element surrounding and isolating the severed tissue from the surrounding tissue.    
   
   
       101 . A method of excising breast tissue, comprising the steps of: 
 providing a guide element having at least one indicator for indicating an angular orientation with respect to a longitudinal axis of the guide element and a cutting device, the cutting device having a deployable cutting element mounted on a shaft and; introducing the guide element into a patient's breast;    advancing the cutting device into the patient's breast, the cutting device being slidably coupled to the guide element so that the guide element guides the cutting device as the cutting device is advanced into the patient's breast;    deploying a cutting element on the cutting device after the advancing step; rotating the shaft so that the cutting element severs breast tissue; and    removing the breast tissue which has been severed by the cutting element.    
   
   
       102 . The method of  claim 101 , wherein: 
 the rotating step is carried out with the shaft rotating less than 180 degrees relative to the guide element.    
   
   
       103 . The method of  claim 101 , wherein: 
 the providing step is carried out with the guide element being a needle.    
   
   
       104 . The method of  claim 101 , wherein: 
 the rotating step is carried out using the angular orientation indicated by the at least one indicator.    
   
   
       105 . The method of  claim 101 , wherein: 
 the removing step is carried out with the severed breast tissue being contained in a collection element carried by the cutting device.    
   
   
       106 . The method of  claim 105 , wherein: 
 the removing step is carried out with the collection element surrounding and isolating the severed tissue from the surrounding tissue.