Marker or filler forming fluid

• US 10,299,881 B2
• Filed: 06/24/2008
• Issued: 05/28/2019
• 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): Eiseman, Adam J
• Application Number:
  US12/214,947
• Publication Number:
  US 20090287078A1
• Time in Patent Office: 3,990 Days
• Field of Search: 600431, 600562
• 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 solution for forming a marker or filler mass for an intracorporeal site. The solution contains a polar, water soluble non-aqueous solvent such as dimethyl sulfoxide and a bioabsorbable, essentially water insoluble polymer such as polylactic acid, or copolymers of lactic acid and glycolic acid. The solution may be delivered to the biopsy site by a suitable syringe and delivery tube. The delivery tube is preferably provided with a releasable radiopaque element on the distal tip which can be released within the polymeric marker mass formed in the biopsy cavity.

Claims

1. A method for marking an intracorporeal site within a patient from which tissue has been removed, comprising:

a. providing a quantity of marker forming fluid which comprises a polar, non-aqueous, water soluble solvent and a relatively water insoluble, bioabsorbable polymeric solute, wherein the bioabsorbable polymeric solute is a copolymer of polylactic acid and polyglycolic acid;

b. varying a ratio of the polar, non-aqueous, water soluble solvent to the relatively water insoluble, bioabsorbable polymeric solute, so as to adjust both a set of delivery characteristics of the marker forming fluid and an in-vivo lifetime of the polymeric mass;

c. advancing a delivery tube having a distal discharge port and a bore extending therein to the distal discharge port into the patient until the distal discharge port is located at the intracorporeal site; and

d. delivering the marker forming fluid through the bore of the delivery tube, out the discharge port and into the intracorporeal site wherein the bioabsorbable polymeric solute forms a polymeric mass,

wherein the delivery tube has a releasable radiopaque distal tip, the method further comprising;

positioning the releasable radiopaque distal tip in the intracorporeal site;

forming in-vivo the polymeric mass about the releasable radiopaque distal tip in the intracorporeal site within the patient;

releasing the releasable radiopaque distal tip from the delivery tube; and

removing the delivery tube from the patient while the releasable radiopaque distal tip remains in the polymeric mass in the intracorporeal site within the patient.

2. The method of claim 1 wherein the releasable distal tip is released after the polymeric mass forms around the releasable distal tip.

3. A method for marking an intracorporeal site within a patient from which tissue has been removed, comprising:

providing a quantity of marker forming fluid which comprises a polar, non-aqueous, water soluble solvent and a relatively water insoluble, bioabsorbable polymeric solute, the quantity of marker forming fluid having a solute-to-solvent ratio range of 10;

90 to 90;

10, and wherein the bioabsorbable polymeric solute is a copolymer of polylactic acid and polyglycolic acid having a polylactic acid-to-polyglycolic acid ratio range of 90;

10 to 60;

40;

varying a ratio of the polar, non-aqueous, water soluble solvent to the relatively water insoluble, bioabsorbable polymeric solute and varying a ratio of polymeric acids in the relatively water insoluble, bioabsorbable polymeric solute, so as to adjust both a set of delivery characteristics of the marker forming fluid and an in-vivo lifetime of the polymeric mass;

advancing a delivery tube having a distal discharge port and a bore extending therein to the distal discharge port into the patient until the distal discharge port is located at the intracorporeal site; and

delivering the marker forming fluid through the bore of the delivery tube, out the discharge port and into the intracorporeal site wherein the bioabsorbable polymeric solute forms a polymeric mass,

wherein the delivery tube has a releasable radiopaque distal tip, the method further comprising;

positioning the releasable radiopaque distal tip in the intracorporeal site;

forming in-vivo the polymeric mass about the releasable radiopaque distal tip in the intracorporeal site within the patient;

releasing the releasable radiopaque distal tip from the delivery tube;

removing the delivery tube from the patient while the releasable radiopaque distal tip remains in the polymeric mass in the intracorporeal site within the patient; and

wherein the releasable radiopaque distal tip is threadably connected to a distal portion of the delivery tube, and the act of releasing comprises rotating the delivery tube relative to the releasable distal tip to unscrew the releasable distal tip from the delivery tube after the polymeric mass is formed around the releasable radiopaque distal tip.