Biopsy site marker and process and apparatus for applying it

Abstract

A biopsy site marker comprises small bodies or pellets of gelatin which enclose substantially in their interior a radio (X-ray) opaque object. The gelatin pellets are deposited into the biopsy site, typically a cylindrical opening in the tissue created by the recent use of a vacuum assisted large core biopsy device, by an applicator device that includes an elongated cylindrical body that forms a flexible tube and a piston slidable in the tube. One end of the tube is placed into the biopsy site. Typically, several gelatin pellets, only some of which typically do, but all of which may contain the radio opaque object, are deposited sequentially into the site through the tube. The radio opaque objects contained in the gelatin bodies are of a non-biological configuration and readily identifiable as man-made object, so that in observation by typical mammography equipment they do not assume the shape of a line, whereby they are readily distinguishable from granules and lines of calcification.

What is claimed is:  
     
         1 . A biopsy site marker comprising: 
 a body of gelatin, and    an X-ray detectable body of specific predetermined non-biological configuration embedded in said body of gelatin.    
     
     
         2 . A biopsy site marker in accordance with  claim 1  where the X-ray detectable body is comprises metal.  
     
     
         3 . A biopsy site marker in accordance with  claim 2  where the X-ray detectable body comprises stainless steel.  
     
     
         4 . A biopsy site marker in accordance with  claim 1  where the X-ray detectable body comprises ceremic materials or metal oxides.  
     
     
         5 . A biopsy site marker in accordance with  claim 1  additionally comprising a plurality of air bubbles embedded in said body of gelatin.  
     
     
         6 . A biopsy site marker in accordance with  claim 1  wherein the gelatin has a Bloom rating in the range between approximately 150 to 300 Bloom.  
     
     
         7 . A biopsy site marker in accordance with  claim 6  wherein the gelatin has a Bloom rating in the range between approximately 200 to 300 Bloom.  
     
     
         8 . A biopsy site marker in accordance with  claim 1  wherein the body of gelatin is dehydrated.  
     
     
         9 . A biopsy site marker comprising: 
 a body of gelatin that has a bloom rating in the range between approximately 150 to 300 Bloom;    a plurality of air bubbles embedded in said body of gelatin, and    an X-ray detectable body of specific predetermined non-biological configuration embedded in said body of gelatin.    
     
     
         10 . A biopsy site marker in accordance with  claim 9  wherein the X-ray ray detectable body of specific predetermined non-biological configuration comprises metal.  
     
     
         11 . A biopsy site marker in accordance with  claim 10  wherein the X-ray detectable body of specific predetermined non-biological configuration comprises stainless steel.  
     
     
         12 . A biopsy site marker in accordance with  claim 9  wherein the body of gelatin is configured in the shape of a cylinder.  
     
     
         13 . A biopsy site marker in accordance with  claim 9  wherein the body of gelatin is dehydrated.  
     
     
         14 . A biopsy site marker in accordance with  claim 12  wherein the body of gelatin is dehydrated and is approximately of 1 to 3 mm in diameter and is approximately 5 to 10 mm long.  
     
     
         15 . A biopsy site marker in accordance with  claim 14  wherein the body of gelatin is approximately of 2 mm in diameter and is approximately 8 mm long.  
     
     
         16 . A biopsy site marker in accordance with  claim 15  wherein the body of gelatin has a Bloom rating in the range between approximately 200 to 300 Bloom.  
     
     
         17 . A biopsy site marker in accordance with  claim 10  wherein the X-ray detectable body of specific predetermined non-biological configuration is configured substantially in the shape of a Greek letter gamma (γ).  
     
     
         18 . A biopsy site marker in accordance with  claim 17  wherein the X-ray detectable body of the Greek letter gamma (γ) configuration consists essentially of an electrochemically etched stainless steel body.  
     
     
         19 . An applicator device for a biopsy site marker, the device comprising: 
 an elongated cylindrical body that forms a flexible tube and includes a cylindrical cavity having an internal lumen, an open end and a closed end and a ramp-shaped opening in proximity of the closed end; and    a piston that is moveable back and forth in the cylindrical cavity forming the tube, the tube being adapted to be loaded in the internal lumen with a plurality of biopsy site marker bodies comprising dehydrated gelatin said marker bodies being disposed between the end of the piston and the ramp-shaped opening when the piston is extended outwardly from the cylindrical cavity.    
     
     
         20 . An applicator device in accordance with  claim 19  wherein the elongated cylindrical body has an internal diameter of approximately 0.070″.  
     
     
         21 . In combination: an applicator tube having an internal lumen, an open end and a closed end and a ramp-shaped opening in proximity of the closed end; 
 a flexible rod dimensioned to fit into and be slidable in the internal lumen, and    a plurality of biopsy site markers comprising a body of dehydrated gelatin, and an X-ray detectable body of specific predetermined non-biological configuration embedded in said body of gelatin, said biopsy site markers being enclosed in the internal lumen, from where they can be pushed out with the flexible rod through the ramp-shaped opening into a biopsy site.    
     
     
         22 . The combination in accordance with  claim 21  wherein the X-ray detectable body of the biopsy site markers comprises metal.  
     
     
         23 . The combination in accordance with  claim 21  where the X-ray detectable body of the biopsy site markers comprises stainless steel.  
     
     
         24 . The combination in accordance with  claim 21  wherein the X-ray detectable body of the biopsy site markers comprises ceramic materials or metal amides.  
     
     
         25 . The combination in accordance with  claim 21  where the biopsy site markers additionally comprise a plurality of air bubbles embedded in said body of gelatin.  
     
     
         26 . The combination in accordance with  claim 21  wherein the gelatin of the biopsy site markers has a Bloom rating in the range between approximately 150 to 300 Bloom.  
     
     
         27 . The combination in accordance with  claim 26  wherein the gelatin of the biopsy site markers has a Bloom rating in the range between approximately 200 to 300 Bloom.  
     
     
         28 . The combination in accordance with  claim 21  further comprising at least one biopsy site marker that has a body of dehydrated gelatin, and lacks the X-ray detectable body of specific predetermined non-biological configuration embedded in said body of gelatin.  
     
     
         29 . The combination in accordance with  claim 28  comprising an array of a plurality of said biopsy site markers having said X-ray detectable body of specific predetermined non-biological configuration and a plurality of said biopsy site markers having a body of dehydrated gelatin and lacking the X-ray detectable body of specific predetermined non-biological configuration, said array being enclosed in the internal lumen.  
     
     
         30 . The combination in accordance with  claim 29  wherein said biopsy site markers having said X-ray detectable body of specific predetermined non-biological configuration and said biopsy site markers having a body of dehydrated gelatin and lacking the X-ray detectable body of specific predetermined non-biological configuration alternate in said array.