Cavity-filling biopsy site markers

• US 8,219,182 B2
• Filed: 08/06/2010
• Issued: 07/10/2012
• Est. Priority Date: 02/02/1999
• Status: Expired due to Fees

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Lubock, Paul, Jones, Michael L., Burbank, Fred H.
• Primary Examiner(s): PELHAM, JOSEPH MOORE
• Application Number:
  US12/852,286
• Publication Number:
  US 20100324416A1
• Time in Patent Office: 704 Days
• Field of Search: None
• 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 2090/392 Radioactive markers
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• 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 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 8/481 involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream analysis of echo signal exploiting properties of a contrast enhancer in devices for short-range imaging with acoustic waves G01S7/52039
• 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: A61K 49/222 characterised by a special physical form, e.g. emulsions, liposomes
• 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

An ultrasound-detectable biopsy marker mass has a detectable in-vivo lifetime during which the marker mass remains readily detectable by ultrasound imaging. The ultrasound-detectable biopsy marker mass is formed of particles of a bio-resorbable material having bubble cavities and having a particle size between about 200 microns and about 500 microns.

Claims

1. An ultrasound-detectable biopsy marker mass which has a detectable in-vivo lifetime during which the marker mass remains readily detectable by ultrasound, and which is formed of particles of a bio-resorbable material having bubble cavities inside the particles and having a particle size between about 200 microns and about 500 microns.

2. The ultrasound-detectable biopsy marker mass of claim 1, wherein the marker mass is a bio-resorbable powder mass having a volume of between about 0.2 ml and about 1.2 ml of powder.

3. The ultrasound-detectable biopsy marker mass of claim 1, the bubble cavities having a size of at least 50 microns, wherein the bubble cavities have geometric centers and the cavity size is measured by length through the geometric centers of the cavities.

4. The ultrasound-detectable biopsy marker mass of claim 1, wherein said bio-resorbable material comprises a bio-resorbable polymeric material.

5. The ultrasound-detectable biopsy marker mass of claim 1, wherein at least a portion of the particles have both internal bubble cavities and have exposed surfaces of broken bubble cavities.

6. An ultrasound-detectable biopsy marker mass which has a detectable in-vivo lifetime during which the marker mass remains readily detectable by ultrasound, and which is formed of particles of a bio-resorbable material having a particle size between about 300 microns and about 500 microns, and at least a portion of the particles having one or more bubble cavities inside a respective particle.

7. The ultrasound-detectable biopsy marker mass of claim 6, the bubble cavities having a size of at least 50 microns, wherein the bubble cavities have geometric centers and the cavity size is measured by length through the geometric centers of the cavities.

8. The ultrasound-detectable biopsy marker mass of claim 6, wherein said bio-resorbable material comprises a bio-resorbable polymeric material.

9. The ultrasound-detectable biopsy marker mass of claim 6, wherein the particles are held together with a binding agent.

10. The ultrasound-detectable biopsy marker mass of claim 6, wherein the respective particle has an exposed surface of at least one broken bubble cavity.

11. A bolus of biopsy marker powder which is ultrasonically detectable in-vivo within a patient'"'"'s biopsy site for a period of at least two weeks but not longer than six months, which comprises a comminuted bio-resorbable polymeric powdered material, at least 80% of the comminuted powder having particles with a particle size of about 300 to about 800 microns and the particles of the comminuted powder having one or more bubble cavities within the particles smaller than the particle size of the particles.

12. The bolus of biopsy marker powder of claim 11, wherein the particles of the comminuted powder have a particle size between about 300 microns and about 500 microns.

13. The bolus of biopsy marker powder of claim 11, wherein the comminuted powder comprises about 65% by weight polylactic acid and about 35% by weight polyglycolic acid.

14. The bolus of biopsy marker powder of claim 11, wherein the comminuted powder has a bulk density of between about 0.8 g/ml and about 1.5 g/ml.

15. The bolus of biopsy marker powder of claim 11, having an ultrasonically detectable in-vivo lifetime of not greater than about 20 weeks.

16. The bolus of biopsy marker powder of claim 11, having an ultrasonically detectable in-vivo lifetime between about 6 weeks and about 12 weeks.

17. The bolus of biopsy marker powder of claim 11, wherein the particles are held together with a binding agent.

18. The bolus of biopsy marker powder of claim 17, wherein the binding agent is selected from the group consisting of gelatin, polyethylene glycol, polyvinyl alcohol, glycerine, acrylic hydrogels, organic hydrogels, and combinations thereof.

19. The bolus of biopsy marker powder of claim 17, wherein the binding agent is selected from the group consisting of bovine collagen, porcine collagen, ovine collagen, equine collagen, synthetic collagen, agar, synthetic gelatin, and combinations thereof.

20. The bolus of biopsy marker powder of claim 11, comprising one part gelatin and about five parts comminuted bio-resorbable polymeric material, the particles of the comminuted material having bubble cavities about 50 to about 200 microns in size.

21. The bolus of biopsy marker powder of claim 11, comprising about one part gelatin to about three parts polymeric material.

22. The bolus of biopsy marker powder of claim 11, wherein at least a portion of the particles have both internal bubble cavities and have exposed surfaces of broken bubble cavities.