IP Library › Granted Patent US 12,396,693
Granted Patent B2
US 12,396,693 · App. 18/245,148 · Granted Aug 26, 2025

Systems and methods for confirming tissue specimens removed using contrast-enhanced x-ray imaging

Inventors: David Wolff (Marlborough, MA); Stewart Schiffman (Marlborough, MA)
Assignee: Hologic, Inc.
A61B6/502A61B6/0414A61B6/4035A61B6/481G06T7/0014G06T2207/10116G06T2207/30068G06T2207/30096
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Quick Facts
Patent No.
US 12,396,693
App. No.
18/245,148
Filed
Mar 13, 2023
Granted
Aug 26, 2025
Kind
B2
Examiner
SONG, HOON K
Art Unit
2884
USPC
378/37
Abstract

For a biopsy guided by contrast-enhanced x-ray imaging, a breast imaging system may image a patient's breast subsequent to injection of contrast agent to locate a site for biopsy and/or position a biopsy device relative to the site. Once a tissue specimen is removed from the site for diagnostic evaluation, a confirmation that the specimen was removed from an intended area of interest for biopsy is performed using the systems and methods described herein. For example, the breast imaging system and/or a separate specimen imaging system may capture high and low energy images of the specimen, subtract the low energy image from the high energy image to generate a subtracted image of the specimen, and determine, based on the subtracted image, that the contrast agent is present within the specimen to confirm the site from which the specimen was removed is the intended site for biopsy.

Claims (55)

1. A method for confirming tissue specimens removed using contrast-enhanced x-ray imaging, the method comprising:

receiving a specimen of breast tissue removed from a site of a patient's breast subsequent to an injection of a vascular contrast agent into the patient;

capturing a high energy image of the specimen;

capturing a low energy image of the specimen;

subtracting the low energy image from the high energy image to generate a subtracted image of the specimen; and

determining, based on the subtracted image of the specimen, that the contrast agent is present within the specimen to confirm the site from which the specimen was removed is an intended area of interest for biopsy.

2. The method of claim 1 , wherein subtracting the low energy image from the high energy image to generate the subtracted image of the specimen further comprises:

applying a weighting factor to the low energy image to generate a weighted low energy image; and

subtracting the weighted low energy image from the high energy image.

3. The method of claim 1 , wherein subtracting the low energy image from the high energy image to generate the subtracted image of the specimen further comprises:

prior to the subtracting, generating a first gain controlled image from the high energy image and a second gain controlled image from the low energy image; and

subtracting the second gain controlled image from the first gain controlled image to generate the subtracted image of the specimen.

4. The method of claim 1 , wherein the contrast agent is opaque in the high energy image of the specimen and the contrast agent is translucent in the low energy image of the specimen such that when the low energy image is subtracted from the high energy image, the presence of the contrast agent in the specimen is visible in the subtracted image of the specimen.

5. The method of claim 1 , wherein the intended area of interest for the biopsy is an area including at least a portion of potentially abnormal breast tissue.

6. A system for confirming tissue specimens removed using contrast-enhanced x-ray imaging, the system comprising:

an image capturing system comprising at least an x-ray source and a detector for imaging a specimen of breast tissue removed during a biopsy from a site of a patient's breast subsequent to an injection of a vascular contrast agent into the patient;

an apparatus for retaining the specimen of breast tissue after removal, the apparatus positioned relative to the x-ray source and the detector to enable the image capturing system to capture images of the specimen; and

an image processing system communicatively coupled to the image capturing system, the image processing system including at least:

a processor; and

a memory coupled to the processor and storing instructions, that when executed by the processor, cause the processor to:

receive, from the image capturing system, a captured high energy image of the specimen;

receive, from the image capturing system, a captured low energy image of the specimen;

subtract the low energy image from the high energy image to generate a subtracted image of the specimen; and

determine, based on the subtracted image of the specimen, the contrast agent is present within the specimen to confirm the site from which the specimen was removed is an intended area of interest for the biopsy.

7. The system of claim 6 , wherein the system is a breast imaging system, and the image capturing system is further operable to image the patient's breast subsequent to the injection of the vascular contrast agent and prior to the biopsy to one or more of locate the site and position a biopsy device relative to the site.

8. The system of claim 7 , wherein the image capturing system comprises a single x-ray source.

9. The system of claim 8 , wherein, when the x-ray source is the single x-ray source, the image capturing system further comprises one or more filters to enable the image capturing system to image both the patient's breast and the specimen, and capture both the high energy and low energy images.

10. The system of claim 7 , wherein the apparatus is one or more of:

a specimen container positioned on the breast imaging system;

a specimen container that is removably coupleable to the breast imaging system and independently rotatable relative to the x-ray source; and

a reservoir of a vacuum assisted biopsy assembly that is independently positionable relative to the x-ray source and the detector.

11. The system of claim 6 , wherein the system is a specimen imaging system separate from a breast imaging system.

12. The system of claim 11 , wherein the image capturing system comprises at least two x-ray sources, a first of the at least two x-ray sources operable to emit an x-ray beam at a high energy to capture the high energy image of the specimen, and a second of the at least two x-ray sources operable to emit an x-ray beam at a low energy to capture the low energy image of the specimen.

13. The system of claim 11 , wherein the apparatus is comprised of a first positioning member and a second positioning member that surround the specimen and are secured to one another to retain the specimen therebetween.

14. The system of claim 6 , wherein the contrast agent is opaque in the high energy image of the specimen and the contrast agent is translucent in the low energy image of the specimen such that when the low energy image is subtracted from the high energy image, the presence of the contrast agent in the specimen is visible in the subtracted image of the specimen.

15. A breast imaging system for confirming tissue specimens removed using contrast-enhanced x-ray imaging, the breast imaging system comprising:

an image capturing system comprising at least an x-ray source, one or more filters, and a detector, the image capturing system operable to:

subsequent to an injection of a vascular contrast agent into the patient and prior to a biopsy, capture a high energy image and a low energy image of a patient's breast to one or more of locate a site for the biopsy and position a biopsy device relative to the site; and

upon removal of a specimen of breast tissue from the site during the biopsy, capture a high energy image and a low energy image of the specimen;

an apparatus for retaining the specimen upon removal, the apparatus positioned relative to the x-ray source and the detector to enable the image capturing system to capture the high energy image and the low energy image of the specimen; and

an image processing system communicatively coupled to the image capturing system, the image processing system including at least:

a processor; and

a memory coupled to the processor and storing instructions, that when executed by the processor, cause the processor to:

receive, from the image capturing system, the captured high energy image of the specimen;

receive, from the image capturing system, the captured low energy image of the specimen;

subtract the low energy image from the high energy image to generate a subtracted image of the specimen; and

determine, based on the subtracted image of the specimen, that the contrast agent is present within the specimen to confirm the site from which the specimen was removed is an intended area of interest for the biopsy.

16. The breast imaging system of claim 15 , wherein at least one of the one or more filters is a specimen imaging filter implemented to enable imaging of the specimen that comprises at least one aperture defined therein, and the specimen imaging filter blocks a portion of an emitted x-ray beam from the x-ray source so that the at least one aperture defines a path of the emitted x-ray beam towards the detector.

17. The breast imaging system of claim 15 , wherein the one or more filters further comprise a high energy acquisition filter to enable capture of the high energy images.

18. The breast imaging system of claim 15 , further comprising a filter assembly including a plurality of filter slots, wherein each of the one or more filters is disposed within a slot of the plurality of filter slots.

19. The breast imaging system of claim 16 , wherein the apparatus is one or more of:

a specimen container positioned on the breast imaging system;

a specimen container that is removably coupleable to the breast imaging system and independently rotatable relative to the x-ray source; and

a reservoir of a vacuum assisted biopsy assembly that is independently positionable relative to the x-ray source and the detector.

20. The breast imaging system of claim 16 , wherein the contrast agent is opaque in the high energy image of the specimen and the contrast agent is translucent in the low energy image of the specimen such that when the low energy image is subtracted from the high energy image, the presence of the contrast agent in the specimen is visible in the subtracted image of the specimen.

Assignments (5)
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 065286/0407 Recorded Apr 24, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC.; GEN-PROBE INCORPORATED; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.; GEN-PROBE PRODESSE, INC.
Reel/Frame 075457/0767 →
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 19, 2023
From: HOLOGIC, INC.; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 065286/0407 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 14, 2023
From: WOLFF, DAVID; SCHIFFMAN, STEWART
To: HOLOGIC, INC.
Reel/Frame 062979/0235 →
Continuity (2)
Provisional Application 63079028 · Sep 16, 2020
Related Publication 20240016461A1 · Jan 18, 2024
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