Device and method for safe location and marking of a biopsy cavity

• US 9,492,570 B2
• Filed: 05/11/2010
• Issued: 11/15/2016
• Est. Priority Date: 12/24/1998
• Status: Expired due to Fees

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Inventors: Sirimanne, D. Laksen, Fawzi, Natalie V., Sutton, Douglas S., Lebovic, Gail S., Conston, Stanley R., Wilson, Peter M., Morrissey, Anne B., Bush, Mary Elizabeth
• Primary Examiner(s): Le, Long V
• Assistant Examiner(s): Weatherby, Ellsworth
• Application Number:
  US12/777,710
• Publication Number:
  US 20100234726A1
• Time in Patent Office: 2,380 Days
• Field of Search: 600/407, 600/426, 600/431, 600/562, 424/423, 424/426
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 2090/3995 Multi-modality markers
• 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

Abstract

Cavity and sentinel lymph node marking devices, marker delivery devices, and methods are disclosed. More particularly, upon insertion into a body, the cavity marking device and method enable one to determine the center, orientation, and periphery of the cavity by radiographic, mammography, echogenic, or other noninvasive imaging techniques. A composition and method are disclosed for locating the sentinel lymph node in a mammalian body to determine if cancerous cells have spread thereto. The composition is preferably a fluid composition consisting of a carrier fluid and some type of contrast agent; alternatively, the contrast agent may itself be a fluid and therefore not need a separate carrier fluid. This composition is capable of (1) deposition in or around a lesion and migration to and accumulation in the associated sentinel node, and (2) remote detection via any number of noninvasive techniques. Also disclosed is a method for remotely detecting the location of a sentinel node by (1) depositing a remotely detectable fluid in or around a lesion for migration to and accumulation in the associated sentinel node and (2) remotely detecting the location of that node with a minimum of trauma and toxicity to the patient. The composition and method may serve to mark a biopsy cavity, as well as mark the sentinel lymph node. The marking methods also may combine any of the features as described with the marking device and delivery device.

Claims

1. A breast biopsy marker comprising:

a tubular percutaneous access device and a pusher extending into the tubular percutaneous access device;

a first non-metallic, non-bioabsorbable marker detectable by ultrasound positioned in the tubular percutaneous access device, the first non-metallic, non-bioabsorbable marker having a length extending between closed first and second ends, wherein the first non-metallic, non-bioabsorbable marker is placed within a body having an outer surface; and

a second non-bioabsorbable metallic marker detectable by X-ray imaging wrapped in a helical pattern about a portion of the outer surface of the body, wherein the body comprises a fibrin-collagen matrix.

2. The breast biopsy marker in accordance with claim 1 wherein the second non-bioabsorbable metallic marker is in the form of a coil.

6. The breast biopsy marker in accordance with claim 1 wherein the second non-bioabsorbable metallic marker contacts the outer surface of the body.

7. The biopsy marker in accordance with claim 1 wherein the body includes a plurality of pores.

3. A breast biopsy marker comprising:

a tubular percutaneous access device and a pusher extending into the tubular percutaneous access device; and

a biopsy marker consisting essentially of;

a first non-bioabsorbable polymer marker detectable by ultrasound positioned in the tubular percutaneous access device, the first non-bioabsorbable polymer marker having an internal closed volume, wherein the first non-bioabsorbable polymer marker is placed within a body having an outer surface; and

a second non-bioabsorbable metallic marker detectable by X-ray imaging wrapped in a helical pattern about a portion of the outer surface of the body, wherein the body comprises a fibrin-collagen matrix.

4. The breast biopsy marker in accordance with claim 3 wherein the second non-bioabsorbable metallic marker is in the form of a coil.

5. The breast biopsy marker in accordance with claim 3 wherein the body is elongated with a first end and a second end and wherein the second non-bioabsorbable metallic marker contacts the outer surface of the body between the first end and second end.

8. A biopsy marker assembly comprising:

a tubular percutaneous access device and a pusher extending into the tubular percutaneous access device; and

a biopsy marker consisting essentially of;

a non-metallic non-bioabsorbable marker element detectable by ultrasound positioned in the tubular percutaneous access device, wherein the non-metallic non-bioabsorbable marker element is placed within a body; and

a metallic marker element detectable by X-ray imaging, the metallic marker element formed of a single wire encircling in a helical pattern at least a portion of the body, wherein the body comprises a fibrin-collagen matrix.

9. The biopsy marker assembly of claim 8 wherein the body defines a closed volume.

10. The biopsy marker assembly of claim 8 wherein the body includes a plurality of pores.

11. The biopsy marker assembly of claim 8 wherein the metallic marker element comprises an elongate member extending from a first end to a second end, and wherein a portion of the elongate member intermediate the first end and the second end is coiled about the body such that the elongate member encircles the body at least once.

12. The biopsy marker assembly of claim 11 wherein the elongate member encircles the body at least three times.