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 . The device of  claim 1  wherein the bioresorbable body is swellable.  
     
     
         3 . The target tissue localization device of  claim 1 , wherein the bioresorbable body is remotely visualizable by at least one of ultrasound and mammography.  
     
     
         4 . The target tissue localization device of  claim 1 , wherein the radiographically detectable marker is a radiopaque marker object.  
     
     
         5 . The target tissue localization device of  claim 2 , wherein the bioresorbable body swells upon contact with body fluid.  
     
     
         6 . The target tissue localization device of  claim 5 , wherein the bioresorbable body swells to substantially fill the biopsy site.  
     
     
         7 . A method for marking a biopsy cavity comprising: 
 a. providing a plurality of bioresorbable bodies with at least one of the bioresorbable bodies having a radiographically detectable marker with a non-natural shape;    b. removing a biopsy specimen from a patient, thereby creating a biopsy cavity; and    c. inserting the bioresorbable bodies into the biopsy cavity to mark the location thereof.    
     
     
         8 . The device of  claim 7  wherein the bioresorbable body is swellable.  
     
     
         9 . The method of  claim 8  wherein the bioresorbable body swells upon contact with body fluid.  
     
     
         10 . The method of  claim 7  wherein the biopsy specimen is tested after removal from the patient.  
     
     
         11 . The method of  claim 7 , wherein the biopsy site is relocated by detecting the radiographically detectable marker.  
     
     
         12 . The method of  claim 7 , wherein the bioresorbable body is collagen.  
     
     
         13 . The method of  claim 7 , wherein the bioresorbable body is gelatin.  
     
     
         14 . The method of  claim 7  wherein the bioresorbable body is a polymer formed of polylactic acid.  
     
     
         15 . The method of  claim 7 , wherein the bioresorbable body comprises at least one bioresorbable body.  
     
     
         16 . The method of  claim 7 , wherein the bioresorbable body substantially fills the biopsy site.  
     
     
         17 . The method of  claim 11 , wherein the biopsy site is relocated by mammography.  
     
     
         18 . The method of  claim 7 , wherein the biopsy site is relocated by ultrasound.  
     
     
         19 . A target tissue localization device comprising: an elongate tubular member having a proximal end, a distal end, and a lumen therebetween, a pluralilty of bioresorbable bodies disposed in the lumen and at least one of the bioresorbable bodies within the inner lumen of the elongate tubular member with a radiopaque marker object contained within the body.  
     
     
         20 . The device of  claim 19  wherein the bioresorbable body is swellable.  
     
     
         21 . The target tissue localization device of  claim 19 , wherein the bioresorbable body is remotely visualizable by at least one of ultrasound and mammography.  
     
     
         22 . The target tissue localization device of  claim 20 , wherein the bioresorbable body swells upon contact with body fluid.  
     
     
         23 . The target tissue localization device of  claim 22 , wherein the bioresorbable body swells to substantially fill the biopsy site.  
     
     
         24 . The device of  claim 19  wherein the bioresorbable body has a non-natural shape.  
     
     
         25 . A method for marking a biopsy cavity comprising: 
 a. providing a bioresorbable body having a non-natural shape containing a radiopaque marker object;    b. removing a biopsy specimen from the breast of a patient, thereby creating a biopsy site; and    c. inserting the bioresorbable body into the biopsy site to mark the location of the biopsy site.    
     
     
         26 . The device of  claim 25  wherein the bioresorbable body is swellable  
     
     
         27 . The method of  claim 26  wherein the bioresorbable body swells upon contact with body fluid.  
     
     
         28 . The method of  claim 25  wherein the biopsy specimen is tested after removal from the patient.  
     
     
         29 . The method of  claim 25 , wherein the biopsy site is relocated by detecting the radiopaque marker.  
     
     
         30 . The method of  claim 25 , wherein the bioresorbable body is collagen.  
     
     
         31 . The method of  claim 25 , wherein the bioresorbable body is gelatin.  
     
     
         32 . The method of  claim 25  wherein the bioresorbable body is a polymer formed of polylactic acid.  
     
     
         33 . The method of  claim 25 , wherein the bioresorbable body comprises at least one bioresorbable body.  
     
     
         34 . The method of  claim 25 , wherein the bioresorbable body substantially fills the biopsy site.  
     
     
         35 . The method of  claim 29 , wherein the biopsy site is relocated by mammography.  
     
     
         36 . The method of  claim 25 , wherein the biopsy site is relocated by ultrasound.  
     
     
         37 . The method of  claim 25  wherein the bioresorbable body has a non-natural shape.  
     
     
         38 . A biopsy site marker, comprising: 
 a. at least one preshaped remotely detectable body formed of bioresorbable material which remains detectable at the biopsy site for at least a predetermined first period of time and which does not interfere with remote imaging of the biopsy site at a predetermined second time point, and    b. a radiographically detectable object.    
     
     
         39 . The marker of  claim 38  wherein the bioresorbable material is swellable.  
     
     
         40 . The target tissue localization device of claim  69 , wherein the remotely detectable body swells upon contact with body fluid.  
     
     
         41 . The marker of  claim 38 , wherein the remotely detectable body is remotely visualizable by at least one of ultrasound and mammography.  
     
     
         42 . The marker of  claim 38 , wherein the radiographically detectable object is radiopaque.  
     
     
         43 . The marker of  claim 38 , wherein the remotely detectable body swells to substantially fill the biopsy site.  
     
     
         44 . The marker of  claim 38 , wherein the remotely detectable body is formed of bioresorbable material that has a solubility coefficient of less than 1×10 −3  grams per 100 cubic centimeters of water.  
     
     
         45 . The marker of  claim 38 , wherein the remotely detectable body is at least in part formed of a bioresorbable polymeric material.  
     
     
         46 . The marker of  claim 35  wherein the polymeric material is selected from the group consisting of polylactic acid, polyglycolic acid, polycapriolactone, gelatin, collagen  
     
     
         47 . The marker of  claim 38  wherein the bioresorbable material is dehydrated.  
     
     
         48 . The marker of  claim 38  wherein the remotely detectable body is detectable at the biopsy site for at least two weeks.  
     
     
         49 . The marker of  claim 39  wherein the remotely detectable body does not interfere with imaging tissue adjacent the biopsy site after about six weeks.  
     
     
         50 . The marker of  claim 48  wherein the remotely detectable body does not interfere with imaging tissue adjacent the biopsy site after about 5 to about 8 months.  
     
     
         51 . The marker of  claim 48  wherein the remotely detectable body does not interfere with imaging tissue adjacent the biopsy site after about 6 months.  
     
     
         52 . The marker of  claim 38  wherein the remotely detectable body has a cylindrical shape.  
     
     
         53 . The marker of clam  38  wherein the remotely detectable body has transverse dimensions of about 1 to 3 mm.  
     
     
         54 . The marker of clam  38  wherein the remotely detectable body has longitudinal dimensions of about 5 to 10 mm.  
     
     
         55 . An intracorporeal site marker for marking a selected site within tissue of a patient, comprising: 
 a body of gel (bioresorbable material); and    a layer of metallic material disposed about at least a portion of the body which is remotely imageable by ultrasound or X-ray so as to be readily distinguishable from biological features within the tissue site.    
     
     
         56 . The biopsy site marker of  claim 55  wherein the metallic material is a metallic salt.  
     
     
         57 . The biopsy site marker of  claim 56  wherein the metallic salt is silver nitrate.