Biopsy site marker and process and apparatus for applying it
First Claim
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.
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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.
134 Citations
30 Claims
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1. A biopsy site marker comprising:
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a body of gelatin, and an X-ray detectable body of specific predetermined non-biological configuration embedded in said body of gelatin. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A biopsy site marker comprising:
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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. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. An applicator device for a biopsy site marker, the device comprising:
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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. - View Dependent Claims (20)
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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. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30)
- 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;
Specification