Cavity-filling biopsy site markers

• US 8,626,270 B2
• Filed: 06/13/2012
• Issued: 01/07/2014
• 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: Burbank, Fred H., Lubock, Paul, Jones, Michael L.
• Primary Examiner(s): PELHAM, JOSEPH MOORE
• Application Number:
  US13/495,408
• Publication Number:
  US 20120253189A1
• Time in Patent Office: 573 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

The invention provides materials, devices and methods for marking biopsy sites for a limited time. The biopsy-marking materials are ultrasound-detectable bio-resorbable powders, with powder particles typically between about 20 microns and about 800 microns in maximum dimension, more preferably between about 300 microns and about 500 microns. The powders may be formed of polymeric materials containing cavities sized between about 10 microns and about 500 microns, and may also contain binding agents, anesthetic agents, hemostatic agents, and radiopaque markers. Devices for delivering the powders include tubes configured to contain the powders and to fit within a biopsy cannula, the powders being ejected by action of a syringe. Systems may include a tube containing powder, and a syringe containing sterile saline. The tube may be configured to fit within a biopsy cannula such as a Mammotome® or SenoCor 360™ cannula.

Claims

1. A marking system for delivering a marker mass into a cavity in a patient, comprising:

a delivery tube; and

an ultrasound-detectable biopsy marker mass carried by the delivery tube for delivery to the cavity, the ultrasound-detectable biopsy marker mass having 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 internal bubble cavities and having a particle size less than about 800 microns.

2. The marking system 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 marking system of claim 1, wherein the particle size is between about 200 microns and about 500 microns, and the bubble cavities have a size of at least 50 microns, wherein the bubble cavities have geometric centers and the bubble cavity size is measured by length through the geometric centers of the bubble cavities.

4. The marking system of claim 1, wherein said bio-resorbable material comprises a bio-resorbable polymeric material and the particle size is between about 200 microns and about 500 microns.

5. The marking system 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. A marking system for delivering a marker mass into a cavity in a patient, comprising:

a delivery tube; and

an ultrasound-detectable biopsy marker mass carried by the delivery tube for delivery to the cavity, the ultrasound-detectable biopsy marker mass being formed of particles of a bio-resorbable material having internal bubble cavities and having a particle size between about 200 microns and about 800 microns.

7. The marking system of claim 6, the bubble cavities having a size of at least 50 microns, wherein the bubble cavities have geometric centers and the bubble cavity size is measured by length through the geometric centers of the bubble cavities.

8. The marking system of claim 6, wherein said bio-resorbable material comprises a bio-resorbable polymeric material.

9. The marking system of claim 6, wherein at least a portion of the particles have both internal bubble cavities and have exposed surfaces of broken bubble cavities.

10. In a marking system for delivering a marker mass into a cavity in a patient via a delivery tube, the marker mass comprising 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 a portion of the comminuted powder having particles with a particle size of about 200 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.

11. The marker mass of claim 10, wherein the portion of the comminuted powder has a particle size between about 300 microns and about 500 microns.

12. The marker mass of claim 10, wherein the comminuted powder comprises about 65% by weight polylactic acid and about 35% by weight polyglycolic acid.

13. The marker mass of claim 10, wherein at least some of the particles have both internal bubble cavities and have exposed surfaces of broken bubble cavities.

14. The marker mass of claim 10, having an ultrasonically detectable in-vivo lifetime of not greater than about 20 weeks.

15. The marker mass of claim 10, having an ultrasonically detectable in-vivo lifetime between about 6 weeks and about 12 weeks.

16. The marker mass of claim 10, wherein the particles are held together with a binding agent.

17. The marker mass of claim 16, wherein the binding agent is selected from the group consisting of gelatin, polyethylene glycol, polyvinyl alcohol, glycerine, acrylic hydrogels, organic hydrogels, and combinations thereof.

18. The marker mass of claim 16, 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.

19. The marker mass of claim 10, 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.

20. The marker mass of claim 10, comprising about one part gelatin to about three parts polymeric material.