Biopsy localization method and device

• US 6,730,042 B2
• Filed: 12/20/2001
• Issued: 05/04/2004
• 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: Fulton, Richard E., Dubrul, William Richard
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/027,157
• Publication Number:
  US 20020058883A1
• Time in Patent Office: 866 Days
• Field of Search: 600/562, 600/565, 600/567, 623/8, 623/23.75, 424/400, 604/116, 606/116, 606/185
• 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 soft target tissue localization device comprising:

a bioabsorbable element locatable at a soft target tissue site of a patient;

said bioabsorbable element being of a material which is palpably harder than the surrounding soft tissue at the soft target tissue site;

said bioabsorbable element having a pre delivery state and a post delivery state; and

the bioabsorbable element having, a longest dimension of at least about 0.5 cm when in the post delivery state.

2. The device according to claim 1 wherein the bioabsorbable element comprises a bioabsorbable filament.

3. The device according to claim 1 further comprising a marker element in contact with the bioabsorbable element.

4. The device according to claim 3 wherein the marker element is a radiopaque marker element.

5. The device according to claim 3 wherein the marker element is located generally centrally within the bioabsorbable element.

6. The device according to claim 3 wherein the marker element is a radiopaque marker element located generally centrally within the bioabsorbable element.

7. The device according to claim 3 wherein the marker element is a permanent marker element.

8. The device according to claim 3 wherein the marker element is a temporary marker element.

9. The device according to claim 1 wherein the bioabsorbable element has margins, said margins being roughened so to help prevent migration of the bioabsorbable element within soft tissue of a patient.

10. The device according to claim 9 wherein the bioabsorbable element has filaments extending from the margins.

11. The device according to claim 10 wherein the filaments are of same material as the bioabsorbable element.

12. The device according to claim 4 wherein the bioabsorbable element is remotely visualizable in its post delivery state by at least one of ultrasound and mammography.

13. The device according to claim 1 wherein the bioabsorbable element is softer in a post delivery state than in a pre delivery state.

14. The device according to claim 4 wherein the bioabsorbable element is of a different hardness in a post delivery state as in a pre-delivery state.

15. A biopsy localization method comprising:

taking a tissue sample from a biopsy site within a patient;

positioning a bioabsorbable element at the biopsy site;

testing the tissue sample; and

if the testing indicates a need to do so relocating the biopsy site by finding the bioabsorbable element by following a bioabsorbable thread, the thread extending from the patient'"'"'s skin to the bioabsorbable element.

16. The method according to claim 15 wherein the positioning step is carried out using said bioabsorbable element and a radiopaque marker.

17. The device according to claim the 16 wherein the radiopaque marker element is a permanent marker element.

18. The device according to claim the 16 wherein the radiopaque marker element is a temporary marker element.

19. The method according to claim 15 wherein the remotely visualizing step is carried out to by at least one of ultrasound, mammography and MRI.

20. The method according to claim 15 further comprising the step of selecting the bioabsorbable element so that after positioning at the target site, the bioabsorbable element has a hardness of at least about 1.5 times as hard as the surrounding tissue.

21. The method according to claim 15 further comprising the step of effectively preventing blood from contacting the bioabsorbable element until the bioabsorbable element is positioned at the target site, the effectively preventing step being carried out by using a hemostatic bioabsorbable element having a non hemostatic biodegradable outer layer.

22. The method according the claim 15 further comprising the step of placing a marker element within the bioabsorbable element.

23. The method according the claim 15 further comprising the step of placing a marker element at a generally central location within the bioabsorbable element.

24. A target tissue localization device comprising:

an elongate tubular member having a proximal end, a distal end, and a lumen therebetween;

a bioresorbable body contained within the elongate tubular member, the bioresorbable body comprising polylactic acid and polyglycolic acid; and

a radiopaque marker carried by the bioresorbable body.

25. The target tissue localization device of claim 24, wherein the bioresorbable body is remotely visualizable by at least one of ultrasound and mammography.

26. The target tissue localization device of claim 24, wherein the radiopaque marker is contained within the bioresorbable body.

27. The target tissue localization device of claim 24, wherein the bioresorbable body comprises at least one bioresorbable body.

28. The target tissue localization device of claim 24, wherein the bioresorbable body swells upon contact with body fluid.

29. The target tissue localization device of claim 28, wherein the bioresorbable body swells upon to substantially fill the biopsy site.

30. A method for marking a biopsy cavity comprising the steps of:

providing a bioresorbable body having a radiopaque marker carried by the bioresorbable body, said bioresorbable body comprising polylactic acid and polyglycolic acid;

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; and

testing the biopsy specimen.

31. The method of claim 30, further comprising the step of relocating the biopsy site by detecting the radiopaque marker.

32. The method of claim 30, wherein the bioresorbable body comprises at least one bioresorbable body.

33. The method of claim 30, wherein the radiopaque marker is contained within the bioresorbable body.

34. The method of claim 31, wherein the radiopaque marker is detected by mammography.

35. The method of claim 31, wherein the radiopaque marker is detected by ultrasound.

36. The method of claim wherein the bioresorbable body swells upon contact with body fluid.

37. The method of claim wherein the bioresorbable body swells upon to substantially fill the biopsy site.