Tissue site markers for in vivo imaging

• US 6,993,375 B2
• Filed: 04/12/2004
• Issued: 01/31/2006
• Est. Priority Date: 02/02/1999
• Status: Expired due to Term

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Jones, Michael L., Burbank, Fred H., Quick, Richard L., Lubock, Paul, Louw, Frank, De Santis, Stephen A.
• Primary Examiner(s): PELHAM, JOSEPH MOORE
• Application Number:
  US10/823,053
• Publication Number:
  US 20040193044A1
• Time in Patent Office: 659 Days
• Field of Search: 600/426, 600/431, 600/414, 600/432, 600/420, 600/458, 128/899
• US Class Current: 600/431
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61K 49/006 Biological staining of tissues in vivo, e.g. methylene blue or toluidine blue O administered in the buccal area to detect epithelial cancer cells, dyes used for delineating tissues during surgery
• CPC Class Codes: A61K 49/222 characterised by a special physical form, e.g. emulsions, liposomes
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027

Abstract

The invention is directed biopsy site markers and methods of marking a biopsy site, so that the location of the biopsy cavity is readily visible by conventional imaging methods, particularly by ultrasonic imaging. The biopsy site markers of the invention have high ultrasound reflectivity, presenting a substantial acoustic signature from a small marker, so as to avoid obscuring diagnostic tissue features in subsequent imaging studies, and can be readily distinguished from biological features. The several disclosed embodiments of the biopsy site marker of the invention have a high contrast of acoustic impedance as placed in a tissue site, so as to efficiently reflect and scatter ultrasonic energy, and preferably include gas-filled internal pores. The markers may have a non-uniform surface contour to enhance the acoustic signature. The markers have a characteristic form which is recognizably artificial during medical imaging. The biopsy site marker may be accurately fixed to the biopsy site so as to resist migration from the biopsy cavity when a placement instrument is withdrawn, and when the marked tissue is subsequently moved or manipulated.

Claims

1. A remotely imageable marker assembly having a plurality of marker bodies within a delivery tube for marking a selected intracorporeal site within a patient, comprising:

a. at least one of the bodies within the delivery tube being an ultrasound detectable body formed of material that dissipates over time at the intracorporeal site;

b. a radiopaque marker element carried by or within the ultrasound detectable body that is persistent at the intracorporeal site and that is distinguishable as being artificial.

2. The remotely imageable marker assembly of claim 1 wherein the ultrasound detectable body is formed at least in part of a material selected from the group consisting of gelatin, reconstituted collagen material, polymeric material, and mixtures and composites thereof.

3. The remotely imageable marker assembly of claim 1 wherein the radiopaque marker element is a metallic band disposed at least partially surrounding the ultrasound detectable body.

4. The remotely imageable marker assembly of claim 3 wherein the metallic band is recognizably artificial when the marker is subject to ultrasound or X-ray imaging.

5. A method of marking a selected intracorporeal tissue site for subsequent location, comprising:

a) providing a delivery tube with a plurality of marker bodies in which at least one of the marker bodies being an ultrasound detectable body formed of material that dissipates over time at the intracorporeal tissue site and the at least one marker body having a radiopaque marker element which is carried on an exterior portion of or within the ultrasound detectable body, which is persistent at the intracorporeal site and which is distinguishable as being artificial; and

b) implanting the ultrasound detectable marker body at a preselected target site, so that the body is detectable when subject to ultrasound imaging.

6. The method of claim 5 wherein implanting at least one marker includes inserting the delivery tube with the at least one marker through a biopsy needle device which has been previously inserted into the tissue site in the course of a biopsy procedure.

7. The method of claim 6 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. providing a piston housed within the delivery tube for expelling the marker from the tip;

II. inserting the delivery tube through the large core biopsy device until a distal tip thereof 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.

8. An intracorporeal site marker assembly having a plurality of marker bodies within a delivery tube for marking a selected site within tissue of a patient, comprising:

a) at least one elongated body of bioabsorbable material that dissipates over time at the intracorporeal tissue site; and

b) a metallic band disposed at least partially surrounding the elongate body which is recognizably artificial when the marker is subject to ultrasound or X-ray imaging and which is persistent at the intracorporeal site.