Imageable biopsy site marker

• US 6,996,433 B2
• Filed: 11/21/2003
• Issued: 02/07/2006
• 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., Lubock, Paul, Forcier, Nancy
• Primary Examiner(s): Jeffery, John A.
• Application Number:
  US10/719,448
• Publication Number:
  US 20040116806A1
• Time in Patent Office: 809 Days
• Field of Search: 600/431, 600/432, 600/426, 600/562, 600/565, 600/567, 378/62, 378/37, 378/162, 221/226, 221/232, 221/303
• 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 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2090/3987 Applicators for implanting 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
• 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

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.

Claims

1. A system for delivering a marker body to a biopsy site, comprising:

a) a delivery cannula having a inner lumen, a proximal end, an opening in the proximal end, a distal end, an elongated discharge port in the distal end and a ramp inclined to a distal portion of the elongated discharge port configured to urge a marker body out of the discharge port;

b) at least one preshaped marker body which is formed of a bioabsorbable material that is slidably disposed within the inner lumen of the delivery cannula; and

c) a plunger which is slidably disposed in part within the inner lumen of the delivery cannula proximal to the at least one marker body and which is configured to move the at least one marker body up the ramp and out of the discharge port in the delivery cannula.

2. The system of claim 1 wherein the at least one marker body is slidably disposed within the inner lumen.

3. The system of claim 1 wherein a plurality of marker bodies are disposed in the inner lumen.

4. The system of claim 1 wherein at least one marker body is solid at a temperature of 40°

C.

5. The system of claim 1 wherein at least one marker body is ultrasonically detectable.

6. The system of claim 1 wherein at least one marker body has a colorant incorporated therein.

7. The biopsy site marker of claim 1 wherein the at least one marker body is formed of a bioabsorbable material selected from the group consisting of gelatin or collagen.

8. The biopsy site marker of claim 7 wherein the collagen is renatured, cross-linked collagen.

9. The biopsy site market of claim 7 wherein the bioabsorbable material is dehydrated.

10. The system of claim 9 wherein the metallic ion bound to the bioabsorbable material is silver ion.

11. The system of claim 1 wherein the at least one marker body has radiographically detectable metallic ion bound to the bioabsorbable material.

12. The system of claim 1 wherein the marker body has a Bloom strength of at least 150.

13. The system of claim 1 wherein the marker body has a Bloom strength of not more than 300.

14. The system of claim 1 wherein the marker body has a Bloom strength of about 200 about 300.

15. The system of claim 1 wherein the marker body has a Bloom strength of about 250 to about 300.

16. A delivery system for a plurality of marker bodies to a biopsy site, comprising:

a) a delivery cannula having a inner lumen configured to receive a plurality of marker bodies, a distal end and a discharge port in the distal end and a ramp leading to the discharge port to facilitate the discharge of marker bodies from the discharge port;

b) a plurality of marker bodies disposed within the inner lumen which are formed of a bioabsorbable material that is solid at a temperature of 40°

C., which are ultrasonically detectable and which are configured to be slidably disposed within the inner lumen of the delivery cannula to facilitate discharge from the cannula; and

c) a plunger which is slidably disposed within the inner lumen of the delivery cannula proximal to the plurality of marker bodies and which is configured to move the marker bodies up the ramp and effect their discharge from the discharge port in the delivery cannula.

17. The delivery system of claim 16 wherein the a plurality of marker bodies are solid at a temperature of 40°

C.

18. The delivery system of claim 16 wherein a plurality of marker bodies are ultrasonically detectable.

19. The delivery system of claim 16 wherein at least one marker body has a colorant incorporated therein.

20. The biopsy site marker of claim 16 wherein a plurality of marker bodies are formed of a bioabsorbable material selected from the group consisting of gelatin or collagen.

21. The biopsy site marker of claim 16 wherein the collagen is renatured, cross-linked collagen.

22. The biopsy site market of claim 16 wherein the bioabsorbable material is dehydrated.

23. The system of claim 16 wherein a plurality of marker bodies have radiographically detectable metallic ion bound to the bioabsorbable material.

24. The system of claim 23 wherein the metallic ion bound to the bioabsorbable material is silver ion.

25. The system of claim 16 wherein a plurality of marker bodies have a Bloom strength of at least 150.

26. The system of claim 16 wherein a plurality of marker bodies have a Bloom strength of not more than 300.

27. The system of claim 16 wherein a plurality of marker bodies have a Bloom strength of shout 200 about 300.

28. The system of claim 16 wherein a plurality of marker bodies have a Bloom strength of about 250 to about 300.

29. A method for marking a biopsy cavity, comprising:

a. providing a delivery system which has a delivery cannula with an inner lumen, and a discharge port at a distal end of the cannula, a ramp leading to the discharge port to facilitate the discharge of at least one marker body from the discharge port and which has at least one marker body slidably disposed within the inner lumen of the cannula, and which has a plunger with a distal portion slidably disposed within the inner lumen;

b. advancing the distal end of the delivery cannula of the delivery system into the biopsy cavity;

c. actuating the plunger to displace the at least one marker body in the inner lumen of the delivery cannula; and

d. driving the at least one marker up the ramp and out of the discharge port, to deposit the at least one marker in the cavity.

30. The method of claim 29 wherein a ramp is provided leading to the discharge port and the marker is urged up the ramp and out the discharge port to deposit the marker in the cavity.