Biopsy localization method and device

• US 6,699,205 B2
• Filed: 07/06/2001
• Issued: 03/02/2004
• Est. Priority Date: 06/22/1998
• Status: Expired due to Term

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Artemis Medical, Inc. (Johnson & Johnson)
• Inventors: Dubrul, William Richard, Fulton, Richard Eustis III
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Szmal, Brian Scott
• Application Number:
  US09/900,801
• Publication Number:
  US 20010049481A1
• Time in Patent Office: 970 Days
• Field of Search: 600/562, 600/565, 600/567, 600/1, 600/2, 600/3, 600/431, 424/9.51, 424/9.52
• US Class Current: 600/562
• 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 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3962 palpable
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 6/502 for diagnosis of breast, i.e. mammography
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A biopsy localization device made according to the invention includes a bioabsorbable element (34), such as a dehydrated collagen plug, delivered in a pre-delivery state to a soft tissue biopsy site (18) of a patient by an element delivery device (32). The bioabsorbable element preferably swells to fill the biopsied open region (26) and preferably is palpably harder than the surrounding soft tissue at the biopsy site. The bioabsorbable element permits the biopsy site to be relocated by palpation to eliminate the need to use metallic clips during biopsies and often eliminates the need for a return to the radiologist for pre-operative localization. In addition, the bioabsorbable element can be used as a therapeutic tool for treatment of the diseased lesion and for hemostasis.

Claims

1. A method for marking a biopsy site, comprising the steps of:

providing a swellable bioresorbable body having a radiopaque marker carried by the bioresorbable body;

removing a biopsy specimen from the breast of a patient, thereby creating a biopsy site;

inserting the bioresorbable body into the biopsy site to mark the location of the biopsy site, wherein the bioresorbable body swells upon contact with body fluid; and

testing the biopsy specimen.

2. The method of claim 1, further comprising the step of relocating the biopsy site by detecting the radiopaque marker.

3. The method of claim 1, wherein the bioresorbable body is collagen.

4. The method of claim 1, wherein the bioresorbable body is gelatin.

5. The method of claim 1, wherein the bioresorbable body is polylactic acid/polyglycolic acid.

6. The method of claim 1, wherein the bioresorbable body comprises at least one bioresorbable body.

7. The method of claim 1, wherein the radiopaque marker is contained within the bioresorbable body.

8. The method of claim 1, wherein the bioresorbable body swells to substantially fill the biopsy site.

9. The method of claim 2, wherein the step of relocating the biopsy site is performed by mammography.

10. The method of claim 2, wherein the step of relocating the biopsy site is performed by ultrasound.