US6347241B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Ultrasonic and x-ray detectable biopsy site marker and apparatus for applying it
Assignee: SenoRx Inc
•
Filing: 1999-06-30
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Granted: 2002-02-12
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Expires: 2019-06-30
Abstract
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.
Inventors
- 👤 Fred H. Burbank
- 👤 Paul Lubock
- 👤 Michael L. Jones
- 👤 Nancy Forcier
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 19:35
CPC Classifications
A; A61; A61K; A61K49/00; A61K49/001; A61K49/006; A61B; A61B90/00; A61B90/39; A61M; A61M37/00; A61M37/0069; A61B10/00; A61B10/02; A61B17/00; A61B2017/00004; A61B2090/3904; A61B2090/3908; A61B2090/3933; A61B2090/3937; A61B2090/395; A61B2090/3987
Claims Analysis
Total Claims: 26
Claim 1
Independent Claim
59 words
A marker body which is deliverable to a biopsy site within a patient, comprising a preshaped pellet formed of bioabsorbable material having a plurality of gas bubbles dispersed therein which are configured to facilitate ultrasonic observation of the pellet at the biopsy site within the patient, and having an X-ray detectable element of specific predetermined non-biological configuration embedded therein.
Claim 2
Dependent Claim
59 words
A marker body which is deliverable to a biopsy site within a patient, comprising a preshaped pellet formed of bioabsorbable material having a plurality of gas bubbles dispersed therein which are configured to facilitate ultrasonic observation of the pellet at the biopsy site within the patient, and having an X-ray detectable element of specific predetermined non-biological configuration embedded therein.
Claim 3
Dependent Claim
20 words
A marker body in accordance with claim 1 wherein the X-ray detectable element of specific predetermined non-biological configuration comprises metal.
Claim 4
Dependent Claim
21 words
A marker body in accordance with claim 2 wherein the X-ray detectable element of specific predetermined non-biological configuration comprises stainless steel.
Claim 5
Dependent Claim
31 words
A marker body in accordance with claim 2 wherein the X-ray detectable element of specific predetermined non biological configuration is configured substantially in a shape of a Greek letter gamma (γ).
Claim 6
Dependent Claim
22 words
A marker body in accordance with claim 2 wherein the X-ray detectable element consists essentially of an electrochemically etched stainless steel element.
Claim 7
Dependent Claim
22 words
A marker body in accordance with claim 1 wherein the body of bioabsorbable material is configured in the shape of a cylinder.
Claim 8
Dependent Claim
29 words
A marker body in accordance with claim 1 wherein the pellet is about 1 to about 3 mm in diameter and is about 5 to about 10 mm long.
Claim 9
Dependent Claim
26 words
A marker body in accordance with claim 7 wherein the bioabsorbable material has a Bloom rating in the range between about 150 to about 300 Bloom.
Claim 10
Dependent Claim
14 words
A marker body in accordance with claim 1 wherein the bioabsorbable material is gelatin.
Claim 11
Dependent Claim
23 words
A marker body in accordance with claim 1 wherein the pellet is approximately 2 mm in diameter and is approximately 8 mm long.
Claim 12
Dependent Claim
122 words
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 within the internal lumen leading to a side opening in the flexible tube 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 configured to be loaded in the internal lumen with a plurality of biopsy site marker bodies according to claim 1 said marker bodies being disposed between the end of the piston and the side opening when the piston is extended outwardly from the cylindrical cavity.
Claim 13
Dependent Claim
20 words
An applicator device in accordance with claim 11 wherein the elongated cylindrical body has an internal diameter of approximately 0.070″.
Claim 14
Dependent Claim
99 words
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 element 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.
Claim 15
Dependent Claim
99 words
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 element 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.
Claim 16
Dependent Claim
19 words
The combination in accordance with claim 13 wherein the X-ray detectable element of the biopsy site markers comprises metal.
Claim 17
Dependent Claim
20 words
The combination in accordance with claim 13 where the X-ray detectable element of the biopsy site markers comprises stainless steel.
Claim 18
Dependent Claim
23 words
The combination in accordance with claim 13 wherein the X-ray detectable element of the biopsy site markers comprises ceramic materials or metal amides.
Claim 19
Dependent Claim
25 words
The combination in accordance with claim 13 where the biopsy site markers additionally comprise a plurality of air bubbles embedded in said body of gelatin.
Claim 20
Dependent Claim
28 words
The combination in accordance with claim 13 wherein the gelatin of the biopsy site markers has a Bloom rating in the range between approximately 150 to 300 Bloom.
Claim 21
Dependent Claim
28 words
The combination in accordance with claim 18 wherein the gelatin of the biopsy site markers has a Bloom rating in the range between approximately 200 to 300 Bloom.
Claim 22
Dependent Claim
39 words
The combination in accordance with claim 13 further comprising at least one biopsy site marker that has a body of dehydrated gelatin, and lacks the X-ray detectable element of specific predetermined non-biological configuration embedded in said body of gelatin.
Claim 23
Dependent Claim
61 words
The combination in accordance with claim 20 comprising an array of a plurality of said biopsy site markers having said X-ray detectable element 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 element of specific predetermined non-biological configuration, said array being enclosed in the internal lumen.
Claim 24
Dependent Claim
48 words
The combination in accordance with claim 21 wherein said biopsy site markers having said X-ray detectable element of specific predetermined non-biological configuration and said biopsy site markers having a body of dehydrated gelatin and lacking the X-ray detectable element of specific predetermined non-biological configuration alternate in said array.
Claim 25
Dependent Claim
60 words
A marker body which is deliverable to a biopsy site within a patient, comprising: a preshaped pellet formed of dehydrated bioabsorbable material having a plurality of gas bubbles dispersed therein which are configured to facilitate ultrasonic observation of the pellet at the biopsy site within the patient, and having an X-ray detectable element of specific predetermined non-biological configuration embedded therein.
Claim 26
Dependent Claim
60 words
A marker body which is deliverable to a biopsy site within a patient, comprising: a preshaped pellet formed of dehydrated bioabsorbable material having a plurality of gas bubbles dispersed therein which are configured to facilitate ultrasonic observation of the pellet at the biopsy site within the patient, and having an X-ray detectable element of specific predetermined non-biological configuration embedded therein.
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