Devices and methods for performing procedures on a breast

Abstract

A device for cutting tissue having a bowed cutting element may include a shaft having a central axis and a tissue cutting element coupled to the shaft. The tissue cutting element may be movable from a collapsed position to an expanded position and may bow outwardly when in the expanded position. The cutting element generally moves in a first plane when moving between the collapsed and expanded positions. The shaft may have a first thickness and a second thickness relative to the central axis of the shaft. The first and second thicknesses may lie in a second plane which is generally parallel to the first plane. The second thickness may be at least 1.25 times larger than the first thickness and the side of the shaft may have the second thickness leading the cutting element during rotation.

1 . A device for cutting tissue having a bowed cutting element, comprising: 
 a shaft having a central axis; and    a tissue cutting element coupled to the shaft, the tissue cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outwardly when in the expanded position, the cutting element moving generally in a first plane when moving between the collapsed and expanded positions;    the shaft having a first thickness and a second thickness relative to the central axis of the shaft, the first and second thicknesses lying in a second plane which is generally parallel to the first plane, the second thickness being at least 1.25 times larger than the first thickness and the side of the shaft having the second thickness leading the cutting element during rotation.    
     
     
         2 . The device of  claim 1 , wherein: 
 the second thickness is at least 1.5 times larger than the first thickness.    
     
     
         3 . The device of  claim 1 , wherein: 
 the tissue cutting device has a tissue collection element which holds the tissue volume cut free from the surrounding tissue.    
     
     
         4 . A device for cutting tissue using a bowed cutting element, comprising: 
 a shaft; and    a tissue cutting element coupled to the shaft, the tissue cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outwardly when in the expanded position, the tissue cutting element moving generally in a first plane when moving between the collapsed and expanded positions;    wherein the shaft is at least 1.25 times thicker on a leading side than on a trailing side, the thickness being measured along a second plane perpendicular to the first plane, the cutting device being rotated during cutting so that the leading side leads the cutting element.    
     
     
         5 . The device of  claim 4 , wherein: 
 the shaft is at least 1.5 times thicker on the leading side than on the trailing side.    
     
     
         6 . The device of  claim 4 , wherein: 
 the shaft is thicker on the leading side adjacent to the cutting element and is substantially the same as the trailing side at substantially all other parts of the shaft.    
     
     
         7 . A method of cutting tissue using a bowed cutting element, comprising the steps of: 
 providing a tissue cutting device having a shaft and a tissue cutting element coupled to the shaft, the tissue cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outwardly when in the expanded position, the tissue cutting element moving generally in a first plane when moving between the collapsed and expanded positions, wherein the shaft has a first and second thicknesses lying in a second plane which is generally parallel to the first plane, the second thickness being on a side of the shaft from which the tissue cutting element expands, the second thickness being at least 1.25 times larger than the first thickness;    introducing the tissue cutting device into tissue;    expanding the tissue cutting element toward the expanded position;    rotating the tissue cutting device so that the cutting element moves through the tissue to cut the tissue, the cutting device being rotated in a direction in which a side having the second thickness leads the cutting element during rotation;    moving the tissue cutting element back toward the collapsed position to cut a tissue volume free from the surrounding tissue.    
     
     
         8 . The method of  claim 7 , wherein: 
 the providing step is carried out with the second thickness being at least 1.5 times larger than the first thickness.    
     
     
         9 . The method of  claim 7 , wherein: 
 the providing step is carried out with the tissue cutting device having a tissue collection element which holds the tissue volume cut free from the surrounding tissue.    
     
     
         10 . The method of  claim 7 , wherein: 
 the providing step is carried out with the shaft having at least the second thickness adjacent to the cutting element.    
     
     
         11 . A method of cutting tissue using a bowed cutting element, comprising the steps of: 
 providing a tissue cutting device having a shaft and a tissue cutting element coupled to the shaft, the tissue cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outwardly when in the expanded position, the tissue cutting element moving generally in a first plane when moving between the collapsed and expanded positions, wherein the shaft is at least 1.25 times thicker on a first side defined in the direction in the cutting element expands than a second side opposite the first side;    introducing the tissue cutting device into tissue adjacent to a tissue volume to be removed;    expanding the tissue cutting element toward the expanded position;    rotating the shaft so that the cutting element moves through the tissue to cut around the tissue volume to be removed, the cutting device being rotated in a direction in which the first side of the shaft leads the cutting element during rotation; and    moving the tissue cutting element back toward the collapsed position to cut a tissue volume free from the surrounding tissue.    
     
     
         12 . The method of  claim 11 , wherein: 
 the providing step is carried out with the shaft being at least 1.5 times thicker on the first side than on the second side.    
     
     
         13 . The method of  claim 11 , wherein: 
 the providing step is carried out with the shaft being thicker on the leading side adjacent to the cutting element and being substantially the same as the trailing side at substantially all other parts of the shaft which is introduced into the tissue.    
     
     
         14 . A method of cutting a tissue mass free from surrounding breast tissue, comprising the steps of: 
 providing a tissue cutting device and a guide element, the tissue cutting device having a tissue cutting element movable from a collapsed position to an expanded position;    inserting the guide element into a breast;    advancing the tissue cutting device into the breast, the tissue cutting device being slidably coupled to the guide element so that the guide element guides advancement of the tissue cutting device into the breast; and    cutting breast tissue with the tissue cutting device, the cutting step being carried out with the guide element indicating a cutting parameter for the cutting device.    
     
     
         15 . The method of  claim 14 , wherein: 
 the cutting step is carried out with the guide element providing an indication of a depth of penetration during the advancing step.    
     
     
         16 . The method of  claim 14 , further comprising the step of: 
 indicating a first angular position relative to a longitudinal axis of the guide element.    
     
     
         17 . The method of  claim 16 , wherein: 
 the indicating step is carried out by also indicating a second angular orientation, wherein the tissue area of interest lies between the first and second angular orientations for use during the cutting step.    
     
     
         18 . The method of  claim 14 , wherein: 
 the advancing step being carried out with the tissue cutting device being advanced over the guide element.    
     
     
         19 . The method of  claim 14 , wherein: 
 the advancing step is carried out with the tissue cutting device being advanced through the guide element.    
     
     
         20 . The method of  claim 14 , wherein: 
 the providing step is carried out with the guide element being a tube;    the inserting step being carried out with the tube having a sharp tip which pierces the breast tissue; and    the advancing step is carried out with the tissue cutting device being introduced into the tube.    
     
     
         21 . The method of  claim 20 , further comprising the step of: 
 removing hot gasses generated during the cutting step through the tube.    
     
     
         22 . The method of  claim 21 , wherein: 
 the removing step is carried out by removing the hot gasses through a space between the tube and the tissue cutting device.    
     
     
         23 . A method of removing breast tissue, comprising the steps of: 
 providing a tissue cutting device and an insertion device having a sharp tip, the tissue cutting device having a cutting element which is movable from a collapsed position to an expanded position, the cutting element being bowed outward when in the expanded position;    inserting the insertion device into a breast with the sharp tip of the insertion device piercing the breast tissue during insertion;    coupling the tissue cutting device to the insertion device so that the tissue cutting device is slidably coupled to the insertion device;    advancing the insertion device into the breast tissue while being slidably coupled to the insertion device;    moving the tissue cutting element toward the expanded position after the withdrawing step;    rotating the tissue cutting device to cut around the tissue to be removed; and    removing the tissue which has been cut free from the surrounding tissue by the tissue cutting device.    
     
     
         24 . The method of  claim 23 , wherein: 
 the providing step is carried out with the insertion device having a tubular body, wherein the sharp tip is removable.    
     
     
         25 . The method of  claim 24 , further comprising the step of: 
 removing the cutting element after the inserting step;    the coupling step being carried out by introducing the cutting device into the insertion device and advancing the cutting device through the tubular body.    
     
     
         26 . The method of  claim 24 , further comprising the step of: 
 securing the guide member to the tissue structure to hold the angular orientation of the guide member after completing the inserting step.    
     
     
         27 . The method of  claim 26 , wherein: 
 the securing step is carried out using an adhesive strip which is adhered to a surface of the tissue through which the cutting device is inserted.    
     
     
         28 . The method of  claim 23 , further comprising the step of: 
 withdrawing the insertion device after the advancing step to expose the tissue cutting element.    
     
     
         29 . The method of  claim 28 , further comprising the step of: 
 removing gas through a space between the tubular body and the cutting device.    
     
     
         30 . The method of  claim 23 , wherein: 
 the removing step is carried out by removing the tissue through a separate incision from an incision through which the tissue cutting element extends.    
     
     
         31 . The method of  claim 23 , further comprising: 
 setting an angular indicator on the guide member which provides an indication of an angular extent of the tissue to be removed.    
     
     
         32 . A method of forming an RF-energized bowed cutting element, comprising the steps of: 
 providing a tissue cutting device having a cutting element coupled to a shaft, the cutting element being movable from a collapsed position to an expanded position, the cutting element being in a substantially straight configuration when collapsed and bowing outwardly from the shaft when in the expanded position; and    marking a first location on the cutting element corresponding to a position on the cutting element where an apex occurs when the cutting element is bowed outwardly, the location being marked for visualization using ultrasound.    
     
     
         33 . The method of  claim 32 , wherein: 
 the marking step is carried out by also marking a second location corresponding to a proximal end and a third location corresponding to a distal end of the cutting element when the cutting element is collapsed.    
     
     
         34 . A device for cutting tissue, comprising: 
 a shaft;    a cutting element coupled to the shaft, the cutting element being movable from a substantially straight position to an expanded position, the cutting element having an apex corresponding to a maximum radial extension of the cutting element when in the expanded position;    a first ultrasound marker on the cutting element positioned on the cutting element at a position corresponding to the apex when in the collapsed position;    a second ultrasound marker which marks a proximal location of the cutting element, and    a third ultrasound marker which marks a distal location on the cutting element.    
     
     
         35 . The device of  claim 34 , wherein: 
 the first ultrasound marker is closer to the distal location than the proximal location.    
     
     
         36 . The device of  claim 35 , wherein: 
 the second and third ultrasound markers are located at proximal and distal ends of the cutting element when the cutting element is in the collapsed position.    
     
     
         37 . A suction sleeve for a soft tissue interventional device that includes a shaft, the suction sleeve comprising a tapered portion defining a predetermined extent, the tapered portion defining a first external surface and a first internal surface, the first internal surface defining an internal axial lumen spanning the predetermined extent, the internal axial lumen being configured to receive the shaft, the first external surface defining a suction port and a plurality of openings that open to the internal axial lumen.  
     
     
         38 . A method for cutting a specimen of soft tissue, comprising the steps of: 
 providing a device including a handle, a shaft coupled to the handle and defining a first end and a second end, a cutting element coupled to the second end of the shaft, and a suction sleeve disposed coaxially around the shaft between the first end of the shaft and the cutting element, the suction sleeve defining a suction port and a plurality of openings near the work element, the suction sleeve being configured to enable suction in through the plurality of openings and out through the suction port;    inserting the device in the soft tissue;    cutting the tissue specimen using the cutting element, and    applying suction to the suction port during the cutting step.    
     
     
         39 . 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;    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.    
     
     
         40 . The method of  claim 39 , wherein: 
 the rotating step is carried out with the shaft rotating less than 180 degrees relative to the guide element.    
     
     
         41 . The method of  claim 39 , wherein: 
 the providing step is carried out with the guide element being a needle.    
     
     
         42 . The method of  claim 39 , wherein: 
 the providing step is carried out with the guide element having at least one indicator for indicating an angular orientation with respect to a longitudinal axis of the guide element.    
     
     
         43 . The method of  claim 42 , wherein: 
 the rotating step is carried out using the angular orientation indicated by the at least one indicator.    
     
     
         44 . The method of  claim 42 , wherein: 
 the rotating step is carried out with at least two angular orientations indicated on the guide element at least one of which being selected by the user.    
     
     
         45 . The method of  claim 39 , wherein: 
 the removing step is carried out with the severed breast tissue being contained in a collection element carried by the cutting device.    
     
     
         46 . The method of  claim 45 , wherein: 
 the removing step is carried out with the collection element surrounding and isolating the severed tissue from the surrounding tissue.    
     
     
         47 . A system for removing breast tissue, comprising: 
 a guide element; and    a cutting device, the cutting device having a deployable cutting element mounted on a shaft, the cutting device being configured to be slidably coupled to the guide element.    
     
     
         48 . The system of  claim 47 , wherein: 
 the guide element is a needle.    
     
     
         49 . The system of  claim 47 , wherein: 
 the guide element has a first indicator for indicating an angular orientation.    
     
     
         50 . The system of  claim 47 , wherein: 
 the cutting element being deployed by bowing an elongate cutting element, the cutting element being coupled to a source of RF energy.    
     
     
         51 . The system of  claim 47 , further comprising: 
 a tissue collection element carried by the cutting device, the tissue collection element surrounding the severed tissue.    
     
     
         52 . A method of cutting a piece of breast tissue, comprising the steps of: 
 providing a tissue cutting device having shaft and a cutting element, the cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outward when moving from the collapsed position to the expanded position;    introducing the tissue cutting device into a breast;    expanding the cutting element toward the expanded position;    rotating the shaft so that the cutting element cuts the breast tissue; and    partially collapsing the cutting element after the expanding and rotating steps so that a portion of the tissue remains trapped between the cutting element and the shaft.    
     
     
         53 . The method of  claim 52 , further comprising the steps of: 
 locking the cutting element in the partially collapsed position,    manipulating the tissue with the tissue cutting device while the cutting element is partially collapsed.    
     
     
         54 . The method of  claim 52 , further comprising the steps of: 
 manipulating the tissue with the tissue cutting device while the cutting element is partially collapsed.    
     
     
         55 . The method of  claim 52 , further comprising the steps of: 
 moving the tissue into a tissue collection element while the tissue is trapped by the partially collapsed cutting element.    
     
     
         56 . The method of  claim 52 , further comprising the step of: 
 cutting a tissue removing channel through breast tissue while the tissue is trapped between the cutting element and the shaft;    the introducing step being carried out with the tissue cutting device extending along an introduction path separate from the tissue removing channel.