Micro-invasive breast biopsy device

Abstract

An apparatus for removing tissue and/or other material from a patient, particularly a breast of a patient, is provided. The apparatus generally includes a handpiece and a tissue removal mechanism connected thereto. The tissue removal mechanism includes a cannula having an open distal tip and an outer diameter of less than about 5 mm, or less than about 2 mm. The mechanism further includes a rotatable element having a distal portion with helical threading. The distal portion of the rotatable element extends beyond the open distal tip of the cannula in order to allow tissue to prolapse between turns of the helical threading. The apparatus is designed to draw soft tissue into the cannula upon rotation of the rotatable element and without the need for supplemental sources of aspiration.

What is claimed is:  
     
         1 . An apparatus for removing material from a target area of a breast of a human or an animal, the apparatus comprising: 
 a handpiece;    a cannula including a proximal end portion structured to be coupled to the handpiece and an open distal tip structured to be placed in a target area of a breast of a human or an animal; and    a rotational element structured to be operatively coupled to a source of rotational energy, the rotational element disposed at least partially in the cannula and being structured to at least assist in drawing material from the target area of a breast into the cannula.    
     
     
         2 . The apparatus of  claim 1  wherein the rotational element and the cannula cooperatively engage to form a source of suction effective in drawing material from a target area of a breast into the cannula in response to rotation of the rotational element.  
     
     
         3 . The apparatus of  claim 2  which includes no other source of suction or aspiration.  
     
     
         4 . The apparatus of  claim 1  wherein the rotational element includes a shaft and one or more outwardly extending projections.  
     
     
         5 . The apparatus of  claim 4  wherein the one or more outwardly extending projections have a substantially helical configuration.  
     
     
         6 . The apparatus of  claim 1  wherein the rotational element includes a distal portion that extends beyond the open distal tip of the cannula.  
     
     
         7 . The apparatus of  claim 6  wherein the distal portion of the rotational element includes one or more outwardly extending projections having a substantially helical configuration.  
     
     
         8 . The apparatus of  claim 6  wherein the rotational element includes a shaft portion that extends beyond the open distal tip of the cannula.  
     
     
         9 . The apparatus of  claim 1  wherein the rotational element includes a distal portion that extends a distance in a range of about 0.02 inches to about 1 inch beyond the open distal tip of the cannula.  
     
     
         10 . The apparatus of  claim 1  wherein the cannula has an outer diameter no greater than about 5 mm.  
     
     
         11 . The apparatus of  claim 1  wherein the cannula has an outer diameter no greater than about 2 mm.  
     
     
         12 . The apparatus of  claim 1  wherein the open distal tip of the cannula is beveled or is substantially perpendicular with respect to a longitudinal axis of the cannula.  
     
     
         13 . The apparatus of  claim 1  further comprising a collection chamber, in communication with the cannula, structured to contain material passed through the cannula.  
     
     
         14 . The apparatus of  claim 13  wherein the collection chamber is structured to facilitate quantification of the material removed from a breast of a human or animal.  
     
     
         15 . The apparatus of  claim 1  wherein the cannula is structured to be manually deformable.  
     
     
         16 . The apparatus of  claim 1  which further comprises a motor operatively coupled to the rotational element to provide rotation to the rotational element.  
     
     
         17 . An apparatus for removing tissue from a target area of a breast of a human or an animal, the apparatus comprising: 
 a handpiece;    a cannula, having an outer diameter of about 5 mm or less, and including a proximal end portion structured to be coupled to the handpiece and an open distal tip structured to be placed in a target area of a breast of a human or animal; and    a rotational element structured to cooperate with the cannula in drawing tissue into the open distal tip in response to rotation of the rotational element, the rotational element including a shaft and having distal portion extending beyond the open distal tip of the cannula, and a proximal end portion structured to be operatively coupled to a source of rotational energy.    
     
     
         18 . The apparatus of  claim 17  wherein the rotational element and the cannula are sized and positioned to cooperate to form suction effective in drawing tissue from a breast into the cannula in response to rotation of the rotational element.  
     
     
         19 . The apparatus of  claim 17  which includes no other source of suction or aspiration.  
     
     
         20 . The apparatus of  claim 17  wherein the rotational element includes one or more outwardly extending projections.  
     
     
         21 . The apparatus of  claim 20  wherein the one or more outwardly extending projections have a substantially helical configuration.  
     
     
         22 . The apparatus of  claim 17  wherein the distal portion of the rotational element includes one or more outwardly extending projections having a substantially helical configuration.  
     
     
         23 . The apparatus of  claim 17  wherein the shaft extends beyond the open distal tip of the cannula.  
     
     
         24 . The apparatus of  claim 17  wherein the distal portion of the rotational element extends a distance in a range of about 0.02 inches to about 1 inch beyond the open distal tip of the cannula.  
     
     
         25 . The apparatus of  claim 17  wherein the cannula has an outer diameter no greater than about 2 mm.  
     
     
         26 . The apparatus of  claim 17  wherein the open distal tip of the cannula is beveled or is substantially perpendicular with respect to a longitudinal axis of the cannula.  
     
     
         27 . The apparatus of  claim 17  further comprising a collection chamber, in communication with the cannula, structured to contain tissue passed through the cannula.  
     
     
         28 . The apparatus of  claim 27  wherein the collection chamber is structured to facilitate quantification of tissue passed through the cannula.  
     
     
         29 . The apparatus of  claim 17  wherein the cannula is manually deformable.  
     
     
         30 . A method of removing material from a breast of a human or an animal, the method comprising the steps of: 
 placing into a breast of a human or an animal a cannula having an open, distal tip and a rotational element disposed at least partially in the cannula; and    rotating the rotational element relative to the cannula, thereby at least assisting in drawing a material from the breast into the open distal tip of the cannula.    
     
     
         31 . The method of  claim 30  which further comprises passing the material from the breast through the cannula.  
     
     
         32 . The method of  claim 30  wherein the placing step includes percutaneously introducing the cannula into the body, and positioning the open distal tip of the cannula in close proximity to the material from the breast to be removed.  
     
     
         33 . The method of  claim 30  wherein the cannula and rotational element are sized and positioned so that the rotating step is effective to create suction effective in drawing the material from the breast into the open distal tip of the cannula.  
     
     
         34 . The method of  claim 30  wherein the cannula has an outer diameter no larger than about 5 mm.  
     
     
         35 . The method of  claim 30  wherein the cannula has an outer diameter no larger than about 2 mm.  
     
     
         36 . The method of  claim 30  wherein the material from the breast is removed without applying additional suction or aspiration to the open distal tip of the cannula.  
     
     
         37 . The method of  claim 30  wherein the step of rotating is effective in drawing the material from the breast into the open distal tip of the cannula as a substantially single continuous piece.  
     
     
         38 . The method of  claim 30  further comprising at least one of collecting the removed material from the breast and observing the removed material from the breast.