IP Library › Granted Patent US 12,263,048
Granted Patent B2
US 12,263,048 · App. 18/528,055 · Granted Apr 1, 2025

Biopsy site marker

Inventors: Estefania Alvarez (Watertown, MA); Adam Kozak (Marlborough, MA); Jaimee Robertson (Marlborough, MA); Stephen Spiegelberg (Marlborough, MA)
Assignee: HOLOGIC, INC.
A61B90/39A61B10/0041A61B2017/00796A61B2017/00845A61B2017/00853A61B2017/00867A61B2017/00898A61B2090/3904A61B2090/3908A61B2090/3925A61B2090/3954A61B2090/3966A61B2090/3987A61B2090/3995
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Quick Facts
Patent No.
US 12,263,048
App. No.
18/528,055
Filed
Dec 4, 2023
Granted
Apr 1, 2025
Kind
B2
Art Unit
3797
USPC
600/431
Abstract

A biopsy site marker configured to expand upon deployment into a biopsy cavity, and visible under several different imaging modalities, comprises a superabsorbent hydrogel component and a radiopaque element. The hydrogel is in a compressed, dehydrated state prior to deployment to facilitate placement of the marker within the biopsy site, and thereafter expands upon deployment in the biopsy site. Such expansion limits migration of the site marker.

Claims (30)

1. A detectable marker for implantation in a targeted site, the marker comprising:

an outer portion formed by polymeric threads and defining an interior region, wherein, upon implantation in the targeted site, the outer portion is configured to transition from a collapsed shape to an expanded shape, the expanded shape being different than the collapsed shape and defining a hyperechoic region of the marker; and a hydrogel body contained within the interior region of the outer portion of the marker, the hydrogel body being configured to transition between a pre-deployment configuration and a post-deployment configuration when exposed to a fluid, and to provide a hypoechoic region of the marker,

wherein, in the post-deployment configuration, the hydrogel body swells to a final, fully expanded size, and

wherein, when the hydrogel body is in the final, fully expanded size, the hydrogel body fills less than an entirety of the interior region of the expanded shape of the outer portion of the marker.

2. The marker of claim 1 , wherein the outer portion of the marker comprises a braided, woven or mesh structure.

3. The marker of claim 1 , wherein the polymeric threads comprise polyethylene fibers.

4. The marker of claim 1 , wherein the hydrogel body comprises one or more of poly ( 2 -hydroxyethyl methacrylate) (pHEMA), Polyvinylpyrrolidone (PVP), poly (ethylene glycol) diacrylate (PEGDA), and Polyvinyl alcohol (PVA).

5. The marker of claim 1 , wherein the polymeric threads include a radiopacifier-loaded fiber.

6. The marker of claim 1 , wherein the polymeric threads include radiopaque and polyester threads.

7. The marker of claim 1 , wherein the expanded shape of the outer portion of the marker is a torpedo-like or teardrop-like shape.

8. The marker of claim 1 , wherein the expanded shape of the outer portion of the marker is different than a shape of the hydrogel body in the post-deployment configuration when the hydrogel body is in the final, fully expanded size.

9. The marker of claim 8 , wherein the shape of the hydrogel body in the post-deployment configuration is a cylindrical shape.

10. The marker of claim 1 , wherein the expanded shape of the outer portion of the marker comprises:

a length extending between a first end of the outer portion and a second end of the outer portion; and

a diameter that varies along the length, wherein a maximum diameter of the outer portion is located closer to the first end of the outer portion than the second end of the outer portion.

11. The marker of claim 10 , wherein the length is about 1.0 cm, and the maximum diameter is about 0.5 cm.

12. The marker of claim 1 , wherein the hyperechoic region is configured to provide a distinct outline around the hypoechoic region under ultrasound imaging of the marker.

13. A detectable marker for implantation in a targeted site, the marker comprising:

a radiopaque outer portion defining an interior region of the marker, the radiopaque outer portion being movable from a collapsed shape to an expanded shape and defining a hyperechoic region of the marker; and

a hydrogel body disposed within the interior region of the radiopaque outer portion, the hydrogel body being configured to swell to a final, fully swelled shape when exposed to a fluid, the final, fully swelled shape of the hydrogel body being configured to partially fill the interior region of the marker, such that the final, fully swelled shape of the hydrogel body is different than the expanded shape of the radiopaque outer portion of the marker, and

wherein the hydrogel body is configured to provide a hypoechoic region of the marker, the hypoechoic region being distinguishable from the hyperechoic region under ultrasound imaging of the marker.

14. The marker of claim 13 , wherein the radiopaque outer portion comprises a braided, woven or mesh structure.

15. The marker of claim 13 , wherein the radiopaque outer portion comprises polymeric threads including polyethylene fibers.

16. The marker of claim 13 , wherein the hydrogel body comprises one or more of poly ( 2 -hydroxyethyl methacrylate) (pHEMA), Polyvinylpyrrolidone (PVP), poly (ethylene glycol) diacrylate (PEGDA), and Polyvinyl alcohol (PVA).

17. The marker of claim 13 , wherein the radiopaque outer portion comprises polymeric threads including a radiopacifier-loaded fiber.

18. The marker of claim 13 , wherein the final, fully swelled shape of the hydrogel body is a cylindrical shape.

19. The marker of claim 13 , wherein the expanded shape of the radiopaque outer portion comprises:

a length extending between a first end of the radiopaque outer portion and a second end of the radiopaque outer portion; and

a diameter that varies along the length, wherein a maximum diameter of the radiopaque outer portion is located closer to the first end of the radiopaque outer portion than the second end of the radiopaque outer portion.

20. The marker of claim 13 , wherein the final, fully swelled shape of the hydrogel body is different than a shape of the interior region of the radiopaque outer portion.

Assignments (5)
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 069172/0436 Recorded Apr 28, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC.; GEN-PROBE INCORPORATED; FAXITRON BIOPTICS, LLC
Reel/Frame 075503/0086 →
SECURITY INTEREST Recorded Apr 8, 2026
From: BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; CYTYC CORPORATION; SUROS SURGICAL SYSTEMS, INC.; GYNESONICS, INC.; BOLDER SURGICAL, LLC; FAXITRON BIOPTICS, LLC; HEALTH BEACONS, INC.; HOLOGIC, INC.
To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT
Reel/Frame 075462/0440 →
SECURITY INTEREST Recorded Apr 8, 2026
From: BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; CYTYC CORPORATION; SUROS SURGICAL SYSTEMS, INC.; GYNESONICS, INC.; BOLDER SURGICAL, LLC; FAXITRON BIOPTICS, LLC; HEALTH BEACONS, INC.; HOLOGIC, INC.
To: CITIBANK, N.A., AS COLLATERAL AGENT
Reel/Frame 075926/0339 →
SECURITY INTEREST Recorded Oct 14, 2024
From: HOLOGIC, INC.; GEN-PROBE INCORPORATED; FAXITRON BIOPTICS, LLC
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 069172/0436 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2023
From: ALVAREZ, ESTEFANIA; KOZAK, ADAM; ROBERTSON, JAIMEE; SPIEGELBERG, STEPHEN
To: HOLOGIC, INC.
Reel/Frame 065887/0429 →
Continuity (3)
Continuation 16463023
Provisional Application 62425953 · Nov 23, 2016
Related Publication 20240173097A1 · May 30, 2024
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