Marker or filler forming fluid

• US 8,447,386 B2
• Filed: 12/14/2010
• Issued: 05/21/2013
• Est. Priority Date: 05/23/2003
• Status: Active Grant

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Burbank, Fred H., Jones, Michael L., Louw, Frank, Lubock, Paul
• Primary Examiner(s): Towa, Rene
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US12/967,639
• Publication Number:
  US 20110092815A1
• Time in Patent Office: 889 Days
• Field of Search: 600/431, 600/562, 604/11, 604/15
• US Class Current: 600/431
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61K 49/226 Solutes, emulsions, suspensions, dispersions, semi-solid forms, e.g. hydrogels

Abstract

A system for at least partially filling and marking a cavity at a site within a patient'"'"'s body includes a marker delivery device having a chamber configured to contain a marking substance and having a mechanism configured to expel the marking substance. A quantity of the marking substance is contained within the chamber of the marker delivery device. The marking substance is configured to at least partially fill the cavity and form therein a porous bioabsorbable body. A delivery tube is coupled in fluid communication with the chamber of the marker delivery device. The delivery tube has a distal end with a discharge port through which the marking substance is expelled. A releasable remotely detectable distal tip is coupled to the distal end of the delivery tube and is configured to be released to remain within the porous bioabsorbable body within the cavity upon the formation thereof.

Claims

1. A system for at least partially filling and marking a cavity at a site within a patient'"'"'s breast from which tissue has been removed, comprising:

a syringe having an elongated body, an inner bore, and a plunger slidably disposed within the inner bore;

a delivery tube having a distal end with a discharge port and a delivery tube bore in fluid communication with the inner bore of the syringe and the discharge port;

a quantity of marker forming fluid within the inner bore of the syringe configured to at least partially fill the cavity at the biopsy site and form therein a porous bioabsorbable body; and

a releasable remotely detectable distal tip at the distal end of the delivery tube comprising radiopaque metal and configured to remain within the porous bioabsorbable body within the cavity upon the formation thereof,

wherein the releasable remotely detectable radiopaque distal tip at the distal end of the delivery tube defines the discharge port.

2. The system of claim 1, wherein the releasable remotely detectable distal tip is threadably connected to the distal end of the delivery tube.

3. The system of claim 1, wherein the releasable remotely detectable distal tip is coupled to an external surface of the distal end of the delivery tube.

4. The system of claim 1, wherein the marker forming fluid comprises a non-aqueous solvent which is relatively soluble in a body fluid or other water based fluid, a bioabsorbable polymeric solute comprising a copolymer in the non-aqueous solvent which is relatively insoluble in body fluid or other water based fluid and which forms in the cavity the porous bioabsorbable body.

5. The system of claim 4, wherein the copolymer comprises about 65% (by wt.) polylactic acid and about 35% (by wt.) polyglycolic acid.

6. The system of claim 1, wherein the quantity of marker forming fluid in the inner bore of the syringe is about 0.2 ml to about 1.2 ml.

7. The system of claim 1, wherein a radiopaque part of the releasable remotely detectable radiopaque distal tip is formed of one or more materials selected from the group consisting of stainless steel, platinum, gold, iridium, tantalum, tungsten, silver, rhodium, nickel, bismuth, other radiopaque metals, alloys of radiopaque metals and mixtures of radiopaque metals, and combinations thereof.

8. The system of claim 1, wherein the marker forming fluid includes at least one agent selected from the group consisting of therapeutic or diagnostic agents.

9. The system of claim 8, wherein the agent is a hemostatic agent.

10. The system of claim 1, wherein the marker forming fluid includes a radioactive element.

11. The system of claim 10, wherein the radioactive element is a brachytherapy seed.

12. The system of claim 1, wherein the marker forming fluid contains about 1 to about 50% by weight water insoluble, bioabsorbable polymeric solute.

13. The system of claim 1, wherein the marker forming fluid contains about 10 to about 90% by weight water insoluble, bioabsorbable polymeric solute.

14. The system of claim 1, wherein the marker forming fluid is dimethyl sulfoxide.

15. A system for at least partially filling and marking a cavity at a site within a patient'"'"'s body from which tissue has been removed, comprising:

a marker delivery device having a chamber configured to contain a marking substance, the marker delivery device having a mechanism configured to expel the marking substance;

a quantity of the marking substance contained within the chamber of the marker delivery device, the marking substance being configured to at least partially fill the cavity at the biopsy site and form therein a porous bioabsorbable body;

a delivery tube coupled in fluid communication with the chamber of the marker delivery device, the delivery tube having a distal end with a discharge port through which the marking substance is expelled; and

a releasable remotely detectable distal tip coupled to an external surface of the distal end of the delivery tube and configured to be released to remain within the porous bioabsorbable body within the cavity upon the formation thereof.

16. The system of claim 15, wherein the releasable remotely detectable distal tip at the distal end of the delivery tube comprises radiopaque metal.

17. The system of claim 15, wherein the marking substance in the chamber of the marker delivery device is a marker forming fluid.

18. The system of claim 17, wherein the marker forming fluid in the chamber of the marker delivery device comprises a non-aqueous solvent which is relatively soluble in a body fluid or other water based fluid, a bioabsorbable polymeric solute comprising a copolymer of polylactic acid and polyglycolic acid in a weight ratio of 90:

10 to 60;

40 in the non-aqueous solvent which is relatively insoluble in body fluid or other water based fluid and which forms in the cavity the porous bioabsorbable body.

19. The system of claim 17, wherein the marker forming fluid in the chamber of the marker delivery device is about 0.2 ml to about 1.2 ml.

20. A system for at least partially filling and marking a cavity at a site within a patient'"'"'s body from which tissue has been removed, comprising:

a marker delivery device having a chamber configured to contain a marking substance, the marker delivery device having a mechanism configured to expel the marking substance;

a quantity of the marking substance contained within the chamber of the marker delivery device, the marking substance being configured to at least partially fill the cavity at the biopsy site and form therein a porous bioabsorbable body;

a delivery tube coupled in fluid communication with the chamber of the marker delivery device, the delivery tube having a distal end with a discharge port through which the marking substance is expelled; and

a releasable remotely detectable distal tip coupled to the distal end of the delivery tube and configured to be released to remain within the porous bioabsorbable body within the cavity upon the formation thereof, wherein the releasable remotely detectable distal tip forms an extension of the delivery tube to define the discharge port.