Imageable biopsy site marker

Abstract

A biopsy site marker having at least one small marker body or pellet of bioresorbable material such as gelatin, collagen, polylactic acid, polyglycolic acid which has a radiopaque object, preferably with a non-biological configuration. The at least one bioresorbable body or pellet with a radiopaque object is deposited into the biopsy site, by an delivery device that includes an elongated tubular body with a piston slidable within the tubular body. One end of the tube is placed into the biopsy site. At least one but preferably several marker bodies or pellets are deposited sequentially into the biopsy site through the tube. At least the bioresorbable materials of the detectable markers remain present in sufficient quantity to permit detection and location of the biopsy site at a first time point (e.g., 2 weeks) after introduction but clear from the biopsy site or otherwise do not interfere with imaging of tissues adjacent the biopsy site at a second time point (e.g., 5-7 months) after introduction.

1 . A target tissue localization device comprising: an elongate tubular member having a proximal end, a distal end, and a lumen therebetween, a plurality of bioabsorbable bodies disposed in the lumen and at least one of the bioresorbable bodies within the inner lumen having a radiographically detectable marker with a non-natural shape.  
     
     
         2 - 57 . (canceled)  
     
     
         58 . A target tissue localization device comprising: 
 an elongate tubular member having a proximal end, a distal end, and a lumen therebetween;    a bioresorbable body contained within the elongate tubular member, the bioresorbable body comprising gelatin;    a radiographically detectable marker carried by the body.    
     
     
         59 . The target tissue localization device of  claim 58 , wherein the bioresorbable body is remotely visualizable by at least one of ultrasound and mammography.  
     
     
         60 . The target tissue localization device of  claim 58 , wherein the radiopaque marker is contained within the bioresbrbable body.  
     
     
         61 . The target tissue localization device of  claim 58 , wherein the bioresorbable body comprises at least one bioresorbable body.  
     
     
         62 . The target tissue localization device of  claim 58 , wherein the bioresorbable body swells upon contact with body fluid.  
     
     
         63 . The target tissue localization device of claim  5 , wherein the bioresorbable body swells to substantially fill the biopsy site.  
     
     
         64 . A method for marking a biopsy cavity comprising the steps of: providing a bioresorbable body having a radiopaque marker carried by the bioresorbable body, said bioresorbable body comprising gelatin; removing a biopsy specimen from the breast of a patient, thereby creating a biopsy site; inserting the bioresorbable body into the biopsy site to mark the location of the biopsy site; and testing the biopsy specimen.  
     
     
         65 . The method of  claim 64 , further comprising the step of relocating the biopsy site by detecting the radiopaque marker.  
     
     
         66 . The method of  claim 64 , wherein the bioresorbable body comprises at least one bioresorbable body.  
     
     
         67 . The method of  claim 64 , wherein the radiopaque marker is contained within the bioresorbable body.  
     
     
         68 . The method of  claim 65 , wherein the radiopaque marker is detected by mammography.  
     
     
         69 . The method of  claim 65 , wherein the radiopaque marker is detected by ultrasound.  
     
     
         70 . The method of  claim 64 , wherein the bioresorbable body swells upon contact with body fluid.  
     
     
         71 . The method of  claim 64 , wherein the bioresorbable body swells to substantially fill the biopsy site.  
     
     
         72 . A target tissue localization device comprising: an elongate tubular member having a proximal end, a distal end, and a lumen therebetween; a bioresorbable body contained within the elongate tubular member, the bioresorbable body comprising polylactic acid; and a radiopaque marker carried by the bioresorbable body.  
     
     
         73 . The target tissue localization device of  claim 72 , wherein the bioresorbable body further comprises polyglycolic acid.  
     
     
         74 . A method for marking a biopsy cavity comprising the steps of: providing a bioresorbable body having a radiopaque marker carried by the bioresorbable body, said bioresorbable body comprising polylactic acid; removing a biopsy specimen from the breast of a patient, thereby creating a biopsy site; inserting the bioresorbable body into the biopsy site to mark the location of the biopsy site; and testing the biopsy specimen.  
     
     
         75 . The method of  claim 74 , wherein the bioresorbable body further comprises polyglycolic acid.  
     
     
         76 . A target tissue localization device comprising: an elongate tubular member having a proximal end, a distal end, and a lumen therebetween; a bioresorbable body contained within the elongate tubular member, the bioresorbable body comprising polyglycolic acid; and a radiopaque marker carried by the bioresorbable body.  
     
     
         77 . A method for marking a biopsy cavity comprising the steps of: providing a bioresorbable body having a radiopaque marker carried by the bioresorbable body, said bioresorbable body comprising polyglycolic acid; removing a biopsy specimen from the breast of a patient, thereby creating a biopsy site; inserting the bioresorbable body into the biopsy site to mark the location of the biopsy site; and testing the biopsy specimen.  
     
     
         78 . An intracorporeal site marker for marking a selected site within tissue of a patient's body, comprising: 
 (a) an ultrasound detectable body including boundaries having a high contrast in acoustical impedance when the marker is placed in tissue of the selected site, so as to efficiently reflect ultrasound during ultrasound imaging; and    (b) a body shape which is recognizably artificial when the marker is subject to ultrasound or X-ray imaging, so as to be readily distinguishable from biological features within the tissue site.    
     
     
         79 . A remotely imageable marker for marking a selected intracorporeal site within a patient, comprising: (a) an ultrasound detectable body; and (b) a radiopaque marker element carried by the ultrasound detectable body on an exterior portion thereof.  
     
     
         80 . The remotely imageable marker of  claim 79 , wherein the ultrasound detectable body is formed at least in part of a material selected from the group consisting of gelatin, collagen, cross-linked collagen, polymeric material, and mixtures and composites thereof.  
     
     
         81 . The remotely imageable marker of  claim 79 , wherein the radiopaque marker element is a metallic band disposed at least partially surrounding the ultrasound detectable body.  
     
     
         82 . The remotely imageable marker of  claim 81 , wherein the metallic band is recognizably artificial when the marker is subject to ultrasound or X-ray imaging, so as to be readily distinguishable from biological features within the tissue site.  
     
     
         83 . A method of marking a selected intracorporeal tissue site for subsequent location, comprising: (a) providing at least one marker having an ultrasound detectable body and a radiopaque marker element carried by the ultrasound detectable body on an exterior portion thereof; and (b) implanting the marker at a preselected target site, so that the body is detectable when subject to ultrasound imaging.  
     
     
         84 . The method of  claim 83 , wherein implanting at least one marker includes inserting the marker through a biopsy needle device which has been previously inserted into the tissue site in the course of a biopsy procedure.  
     
     
         85 . The method of  claim 84 , wherein inserting the at least one marker through a biopsy needle device includes: (a) using a vacuum-assisted large core biopsy device as the biopsy needle device; and (b) the insertion of the marker includes: (i) loading the marker into a marker applicator device having an elongated marker insertion tube for holding the marker, the tube having a distal tip and a piston housed within the tube for expelling the marker from the tip; (ii) inserting the marker insertion tube through the large core biopsy device until the tip is adjacent the tissue site; and (iii) depressing the piston to expel the at least one marker from the tube to implant adjacent the tissue site.