Methods and chemical preparations for time-limited marking of biopsy sites

• US 6,427,081 B1
• Filed: 09/05/2000
• Issued: 07/30/2002
• 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): PELHAM, JOSEPH MOORE
• Application Number:
  US09/654,920
• Time in Patent Office: 693 Days
• Field of Search: 600/414, 600/420, 600/426, 600/458, 424/9.1, 128/898, 128/899, 606/114, 606/117
• 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 2090/3788 transmitter only
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3929 Active markers
• 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 2090/3975 active
• 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
• 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

Detectable markers that may be introduced into a cavity created by removal of a biopsy specimen to mark the location of the biopsy site so that it may be located in a subsequent medical/surgical procedure. The markers remain present in sufficient quantity to permit detection and location of the biopsy site at a first time point (e.g., 2 weeks) after introduction but clear from the biopsy site or otherwise not interfere with imaging of tissues adjacent the biopsy site at a second time point (e.g., 5-7 months) after introduction.

Claims

1. A marker for marking a cavity site within the body of a mammalian patient from which a tissue sample has been removed, said marker formed at least in part of a clearance delaying component, and being characterized by remaining present at the cavity site in sufficient quantity to permit detection and location of the cavity site for at least a predetermined first time period after introduction to the cavity site.

2. An intracorporeal marker for marking a cavity site within the body of a mammalian patient from which A tissue sample has been removed, comprising a mass of material that is detectable by at least two remote imaging detection methods when introduced into the cavity site from which tissue has been removed, that remains detectable at the cavity site for at least a predetermined first time period after its introduction into the cavity site and that does not interfere worth imaging of tissue adjacent the cavity site during a predetermined second period of time after the first period of time.

3. The marker of claim 2 wherein the detectable mass is imageable, and remains imageable for at least the first predetermined time period but clears sufficiently from the site so as to not interfere with imaging of tissue adjacent the site during the second predetermined time period.

4. The marker of claim 3 wherein the detectable mass is imageable by at least one of methods consisting of

X-ray;

fluoroscopy;

mammography;

computed tomography;

magnetic resonance imaging;

ultrasound;

Doppler,

radiation detector; and

,

combinations thereof.

5. The marker of claim 2 wherein the detectable mass is detectable by palpation.

6. The marker of claim 5 wherein the detectable mass is selected from the group consisting of:

at least one balloon;

at least one bead;

a viscous, flowable material;

a collagenous material,

a gelatinous material;

cross-linked gelatin; and

,

possible combinations thereof.

7. The marker of claim 2 wherein the detectable mass is visually detectable.

8. The marker of claim 7 wherein the detectable mass includes a colored substance selected from the group consisting of:

a dye;

a colorant;

colorant particles;

carbon; and

,

possible combinations thereof.

9. The marker of claim 2 wherein the detectable mass is detectable by at least two remote imaging detection methods selected from the group consisting of:

magnetic resonance imaging (MRI);

ultrasound imaging;

Doppler imaging;

x-ray imaging;

computer-assisted tomography (CAT);

mammography;

fluoroscopy;

other roentgenological imaging methods;

visualization; and

detection of emission.

10. The marker of claim 2 wherein the detectable mass will interfere with imaging of tissue adjacent to the site and will remain at the site in sufficient quantity to permit location of the site by imaging through the first period of time and will clear sufficiently from the site so as to not interfere with imaging of tissue adjacent the site during the second period of time.

11. The marker of claim 2 wherein the detectable mass of material is of sufficient quantity that, if introduced into the cavity site alone, would clear from the cavity site and be not detectable 2 weeks after introduction and includes a clearance delaying component that delays the clearance of said material from the cavity site such that (i) a detectable quantity of said material remains present at the cavity site until at least said first time point and (ii) said material clears sufficiently from the cavity site to permit imaging of tissue adjacent to the cavity site without interference from said detectable marker at said second time point.

12. The marker of claim 11 wherein the detectable mass of material is a chemical compound having a solubility constant of less than 1×

10−

3 grams per 100 cubic centimeters of water.

13. The marker of claim 12 wherein said chemical compound is selected from the group consisting of:

AgCl;

Agl;

BaCO₃;

BaSO₄;

K;

CaCO₃;

ZnO;

Al₂O₃; and

,

the possible combinations thereof.

14. The marker of claim 11 wherein the detectable mass of material is selected from the group consisting of:

AGNO3;

ammonium salts;

sodium salts;

potassium salts;

ethiodized oil;

sohexol;

isopamidol;

gas;

lipid;

oil; and

,

the possible combinations thereof.

15. The marker of claim 11 wherein the clearance delaying element is selected from the group consisting of:

polylactic acid;

polyglycolic acid;

polycapriolactone;

an encapsulating material;

collagen

renatured collagen;

gelatin;

renatured gelatin;

crosslinked gelatin;

a balloon;

a microsphere; and

the possible combinations thereof.

16. The marker of claim 11 wherein the detectable mass of material is detectable by radiographic imaging.

17. The marker of claim 11 wherein the detectable mass of material is detectable by monographic imaging.

18. The marker of claim 11 wherein the detectable mass of material is detectable by magnetic imaging.

19. The marker of claim 11 wherein the detectable mass of material comprises a dry powder.

20. The marker of claim 11 wherein the detectable mass of material comprises at least one sponge.

21. The marker of claim 11 wherein the detectable mass comprises a suspension.

22. The marker of claim 11 wherein the detectable mass comprises a slurry.

23. The marker of claim 11 wherein the detectable mass comprises a collagenous material having radiographically imageable matter attached thereto.

24. The marker of claim 23 wherein the collagenous material of the marker comprises renatured collagen.

25. The marker of claim 24 wherein the colagenous material is covalently crosslinked.

26. The marker of claim 24 wherein the radiographically imageable matter includes metal ions.

27. The marker of claim 24 wherein the radiographically imageable matter comprises a gas.

28. The marker of claim 24 wherein the collagenous material of the marker comprises renatured collagen and the radiographically imageable matter of the marker comprises metal ions that are bound to said renatured collagen.

29. The marker of claim 28 wherein the metal ions are silver ions.

30. The marker of claim 24 wherein the detectable mass is a gelatinous material having radiographically imageable matter combined therewith.

31. The marker of claim 30 wherein the gelatinous material is renatured gelatin.

32. The marker of claim 30 wherein the gelatinous material is covalently crosslinked.

33. The marker of claim 30 wherein the radiographically imageable matter comprises metal ions.

34. The marker of claim 30 wherein the radiographically imageable matter comprises a gas.

35. The marker of claim 30 wherein the gelatinous material is renatured gelatin and the radiographically imageable matter comprises metal ions that are bound to said renatured gelatin.

36. The marker of claim 35 wherein the metal ions are silver ions.