Biopsy cavity marking device

• US 8,306,602 B2
• Filed: 09/30/2005
• Issued: 11/06/2012
• Est. Priority Date: 12/24/1998
• Status: Expired due to Term

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Inventors: Sirimanne, D. Laksen, Sutton, Douglas S., Fawzi, Natalie V., Lebovic, Gail
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US11/241,500
• Publication Number:
  US 20060036159A1
• Time in Patent Office: 2,594 Days
• Field of Search: 600407-437, 424423-426, 623/1, 623/11, 623/12
• US Class Current: 600/414
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 8/481 involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream analysis of echo signal exploiting properties of a contrast enhancer in devices for short-range imaging with acoustic waves G01S7/52039
• 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

Abstract

These are site marking devices for marking a selected site within tissue of a patient. More particularly, the devices include an elongated body of gel and a metallic band disposed at least partially surrounding the body of gel. The body of gel is recognizably artificial when the marker is subject to ultrasound or x-ray imaging. Therefore, it is readily distinguishable from biological features within the tissue site.

Claims

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

(A) providing at least one marker having an ultrasound detectable body and a radiopaque marker element carried by the ultrasound detectable body on an exterior portion thereof; and

(B) implanting the at least one marker at a preselected target site, so that the ultrasound detectable body is detectable when subject to ultrasound imaging, wherein implanting the at least one marker includes inserting 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 and 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) loading the marker into a marker applicator device having an elongated marker insertion tube for holding the marker, the tube having a distal tip and a piston housed within the tube for expelling the marker from the tip;

(ii) inserting the marker insertion tube through the large core biopsy device until the tip 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.

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

(A) providing at least one marker having an ultrasound detectable body and a radiopaque marker element carried by the ultrasound detectable body on an exterior portion thereof wherein the ultrasound detectable body expands relative to the radiopaque marker element; and

(B) inserting the at least one marker through a biopsy needle device which has been previously inserted through the skin and into the tissue site in the course of a biopsy procedure;

wherein the step of inserting includes directing the at least one marker from a point outside the body such that the marker passes through the needle to the intracorporeal tissue site.

3. A remotely imageable marker for marking a selected intracorporeal site within a patient, comprising:

(a) an ultrasound detectable body; and

(b) a radiopaque marker element carried by the ultrasound detectable body on an exterior portion of the ultrasound detectable body, the radiopaque marker element being remotely detectable within the patient;

wherein the ultrasound detectable body expands relative to the radiopaque marker element.

4. The remotely imageable marker of claim 3, wherein the ultrasound detectable body is formed at least in part of a material selected from the group consisting of gelatin, collagen, cross-linked collagen, polymeric material, and mixtures and composites thereof.

5. The remotely imageable marker of claim 3, wherein the ultrasound detectable body is formed as a solid cylinder.

6. The remotely imageable marker of claim 3, wherein the radiopaque marker element is in the form of a metallic wire helically wrapped about the ultrasound detectable body.

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

8. The remotely imageable marker of claim 7, wherein the metallic band is recognizably artificial when the marker is subject to ultrasound or X-ray imaging, so as to be readily distinguishable from biological features within the tissue site.