Devices and methods for performing procedures on a breast

Abstract

A needle is used to mark a tissue area of interest. The needle may have one or more indicators which indicate selected angular orientations relative to the needle. The indicators may also be coupled to anchors which are deployed in the tissue to anchor the needle in the tissue. The needle may be positioned to guide an excisional device to remove tissue.

1 . A method of positioning a needle in a patient's breast for a medical procedure, comprising the steps of:
 providing a needle having a proximal portion and a distal portion, the proximal portion being movable between a rigid condition and a flexible condition which may be selected by a user;   positioning the distal portion in a patient's breast with the proximal portion remaining outside the breast, the distal portion being in the rigid condition for facilitating introduction into the patient's breast;   changing the proximal portion from the rigid condition to the flexible condition after the positioning step; and   performing a medical procedure on the patient's breast.   
     
     
         2 . The method of  claim 1 , wherein:
 the performing step includes the step of removing breast tissue.   
     
     
         3 . The method of  claim 2 , wherein:
 the performing step is carried out by removing tissue not penetrated by the needle.   
     
     
         4 . The method of  claim 1 , further comprising the step of:
 creating another rigid condition at the proximal portion after the changing step and before the performing step.   
     
     
         5 . The method of  claim 1 , wherein:
 the changing step is carried out by removing a stiffener from the proximal portion of the needle.   
     
     
         6 . The method of  claim 1 , wherein:
 the performing step is carried out by guiding a cutting device into the patient using the needle to guide the cutting device.   
     
     
         7 . The method of  claim 1 , wherein:
 the performing step is carried out with a tissue removal device being guided by the needle and the medical procedure being a tissue removal procedure.   
     
     
         8 . The method of  claim 7 , wherein:
 the performing step is carried out with the tissue removal device rotating to move a cutting element along an arc within the tissue.   
     
     
         9 . The method of  claim 7 , wherein:
 the performing step is carried out with the tissue removal device being rotationally constrained by the needle at a first location.   
     
     
         10 . The method of  claim 9 , wherein:
 the performing step is carried out with the first location coinciding with a first angular indicator which indicates an angular position with respect to a longitudinal axis of the needle to the user.   
     
     
         11 . The method of  claim 7 , wherein:
 the performing step is carried out with the tissue removal device having a cutting element which moves between bowed and retracted positions, the cutting element being in a bowed position while cutting tissue.   
     
     
         12 . The method of  claim 7 , wherein:
 the performing step is carried out with the tissue removal device engaging a stop on the needle which prevents further longitudinal movement of the tissue removal device.   
     
     
         13 . The method of  claim 12 , wherein:
 the performing step is carried out with the stop positioning the tissue removal device in a predetermined longitudinal position.   
     
     
         14 . The method of  claim 1 , further comprising the step of:
 moving an indicator on the needle, the indicator being moved to a position which indicates an angular position with respect to a longitudinal axis of the needle.   
     
     
         15 . The method of  claim 14 , wherein:
 the moving step is carried out with the position of the indicator providing an angular bound of tissue to be removed from the breast.   
     
     
         16 . A needle for marking a patient's breast when performing a medical procedure on the patient, comprising:
 a distal portion having an elongate, rigid shaft; and   a proximal portion coupled to the distal portion, the proximal portion being selectively movable between a rigid condition and a flexible condition, wherein the proximal portion is in the rigid condition during introduction into a patient's breast and is movable to the flexible condition after introduction into the breast.   
     
     
         17 . The needle of  claim 16 , wherein:
 the proximal portion has a removable stiffener.   
     
     
         18 . The needle of  claim 16 , further comprising:
 an indicator which is movable to a selected angular orientation relative to a longitudinal axis.   
     
     
         19 . The needle of  claim 16 , wherein:
 the needle has a longitudinal stop which prevents further longitudinal movement of a tissue removal device, the stop being oriented to position the tissue removal device in a predetermined longitudinal position relative to the tissue be removed after positioning the needle in the breast.   
     
     
         20 . The needle of  claim 16 , further comprising:
 an anchoring element which is movable together with the indicator to a selected orientation relative to the longitudinal axis.   
     
     
         21 . The needle of  claim 20 , wherein:
 the anchoring element is a thin, elongate element which pierces the breast tissue.   
     
     
         22 . The needle of  claim 21 , further comprising:
 a shaft having an opening;   the element extends through the opening in the shaft.   
     
     
         23 . The needle of  claim 20 , wherein:
 the anchoring element is a J-shaped wire.   
     
     
         24 - 54 . (canceled)