Biopsy marker with in situ-generated imaging properties

• US 8,401,622 B2
• Filed: 12/17/2007
• Issued: 03/19/2013
• Est. Priority Date: 12/18/2006
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Talpade, Dnyanesh A., Pathak, Chandrashekhar
• Primary Examiner(s): Le, Long V.
• Assistant Examiner(s): Negarestan, Farshad
• Application Number:
  US12/519,656
• Publication Number:
  US 20100010341A1
• Time in Patent Office: 1,919 Days
• Field of Search: 600/424, 600/431, 424/9.4, 424/1.11, 424/9.3, 424/9.32, 424/9.1, 424/423, 530/353, 514/1, 514/7.6
• 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 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/392 Radioactive markers
• 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 2090/3995 Multi-modality markers
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61K 49/0002 General or multifunctional contrast agents, e.g. chelated agents
• CPC Class Codes: A61K 49/0409 Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is not a halogenated organic compound
• CPC Class Codes: A61K 49/18 characterised by a special physical form, e.g. emulsions, microcapsules, liposomes
• CPC Class Codes: A61K 49/222 characterised by a special physical form, e.g. emulsions, liposomes

Abstract

A biopsy marker having radio-opaque properties that are derived in situ, based on a natural a biological response, such as for example, calcification, accumulation or tissue-concentration of a chemical agent so as to provide an imaging contrast. A biodegradable foam such as collagen foam or gelatin foam is embedded with a biological tissue that is susceptible to the calcification. Initially the marker can be imaged using ultrasound, but over time, the embedded material calcifies causing it to become visible under radiation imaging.

Claims

1. An intracorporeal marker, for marking a site within living tissue of a human host, comprising:

a body having an outer portion of porous biodegradable material having gas-filled voids and an inner portion located within the outer portion, the inner portion including biological material having elastin that becomes calcified over time when the body is adapted to be inserted in the tissue of the human host, and an agent that promotes calcification of the elastin.

2. The marker of claim 1, wherein the biological material having elastin includes porcine aortic wall tissue.

3. The marker of claim 1, wherein the elastin is cross-linked.

4. The marker of claim 1, wherein the agent that promotes calcification of the elastin comprises at least one of bone growth factor, phospholipids, and polyethylene glycol.

5. The marker of claim 1, wherein the inner portion is entirely encased within the outer portion.

6. The marker of claim 1, wherein the outer portion includes collagen.

7. The marker of claim 1, wherein the outer portion includes gelatin.

8. A method of in vivo identification of a position in soft tissue, comprising:

inserting into breast tissue of a patient a site marker having a porous biodegradable outer portion and an inner portion that includes elastin and a biological additive that promotes calcification of the elastin, the inner portion being surrounded by the outer portion;

imaging the site marker under ultrasound at a first time when the outer portion is imageable prior to being biodegraded; and

imaging the site marker under radiation at a second time following the first, wherein the second time follows the first by an interval during which calcification of the inner portion occurs.

9. An intracorporeal marker for marking a site within living tissue of a human host, the marker comprising:

a body having a biodegradable outer portion configured to provide visibility under ultrasound at a first time interval prior to being biodegraded, and having an inner portion within the biodegradable outer portion having biological material that calcifies to become visible under x-ray or MRI during a second time interval different from the first time interval, wherein;

the biodegradable outer portion comprising porous biodegradable material having gas-filled voids, and

the inner portion having biological material including elastin as a substantial component, and an agent that promotes calcification, such that the inner portion becomes calcified over time during the second interval when the body is adapted to be inserted in the tissue of the human host due to a physiological mechanism of the host.

10. The marker of claim 9, wherein the biological material having elastin includes porcine aortic wall tissue.

11. The marker of claim 9, further comprising at least one of bone growth factor, phospholipids, and polyethylene glycol.

12. The marker of claim 9, wherein the outer portion defines a cylindrical shape and the inner portion is encased within the outer portion.

13. The marker of claim 9, wherein the inner portion is entirely encased within the outer portion.

14. The marker of claim 9, wherein the body has gas-filled pores.

15. The marker of claim 9, wherein the outer portion includes collagen.

16. The marker of claim 9, wherein the outer portion includes gelatin.

17. The marker of claim 9, wherein the biological material is configured for interacting with an antibody carrying a chemical substance that can be detected by an imaging modality.

18. The marker of claim 9, wherein the biological material undergoes calcification in 30 days to five years.

19. The marker of claim 9, wherein the first time interval is up to six months.