IP Library › Granted Patent US 12,193,886
Granted Patent B2
US 12,193,886 · App. 18/107,113 · Granted Jan 14, 2025

Needle breast biopsy system and method of use

Inventors: Kenneth DeFreitas (Patterson, NY); Ian Shaw (Yorktown Heights, NY); John LaViola (Orange, CT); Kathleen Pickett (Uncasville, CT); Nikolaos A. Gkanatsios (Danbury, CT); Aaron Fand (Bethel, CT); Christopher Ruth (Boxford, MA)
Assignee: Hologic, Inc.
A61B90/17A61B6/12A61B10/0233A61B90/11A61B6/502A61B2017/3409A61B34/25A61B2090/376
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Quick Facts
Patent No.
US 12,193,886
App. No.
18/107,113
Filed
Feb 8, 2023
Granted
Jan 14, 2025
Kind
B2
Art Unit
3797
USPC
600/427
Abstract

A tilted needle biopsy assembly is provided for mounting on an x-ray system. Because the biopsy needle is angled relative to at least one of the detector and the x-ray source, x-ray imaging may be performed during the biopsy procedure without interference by the biopsy device. The angled biopsy needle additionally allows improved access to the axilla and chest wall of the patient. The stereotactic biopsy device of the present invention may be coupled to any x-ray system, whether upright or prone, including but not limited to mammography systems, tomosynthesis systems, and combination mammography/tomosynthesis systems. The system flexibly supports the use of any mode of image capture (i.e., scout, two dimensional mammogram, three-dimensional reconstructed volume) for either or both target visualization and target localization. With such an arrangement, a needle biopsy assembly having improved patient coverage is provided for use with a variety of different x-ray imaging platforms.

Claims (37)

1. A lateral biopsy unit for a breast imaging system, comprising:

a support arm attached to the breast imaging system via a coupling mechanism;

a lateral biopsy arm securable to the support arm;

a holster mount plate coupled to the lateral biopsy arm; and

a biopsy holster mounted on the holster mount plate;

wherein the lateral biopsy arm is disposed at an angle to both the support arm and the holster to allow lateral access to a breast by a biopsy needle secured to the holster.

2. The lateral biopsy unit of claim 1 , wherein the lateral biopsy arm further comprises:

a first thumb wheel, wherein rotation of the first thumb wheel results in manual translation of the holster.

3. The lateral biopsy unit of claim 2 , wherein rotation of the first thumb wheel is configured to translate the holster toward or away from the breast.

4. The lateral biopsy unit of claim 1 , wherein the holster is configured to be motorized to move toward or away from the breast.

5. The lateral biopsy unit of claim 1 , wherein the holster is positionable relative to the lateral biopsy arm so as to translate the holster toward or away from the breast.

6. The lateral biopsy unit of claim 1 , further comprising an attachment mechanism configured to attach the lateral biopsy arm to the support arm.

7. The lateral biopsy unit of claim 6 , wherein the attachment mechanism includes at least one of a clamp or a second thumb wheel.

8. The lateral biopsy unit of claim 1 , further comprising an electrical connection on the holster mount plate and a connector on the lateral biopsy arm, when the lateral biopsy arm is coupled to the holster mount plate, the electrical connection mounts to the connector.

9. The lateral biopsy unit of claim 1 , wherein the lateral biopsy arm includes a support bracket surrounding the support arm.

10. The lateral biopsy unit of claim 9 , wherein the support bracket is removable from one end of the support arm.

11. The lateral biopsy unit of claim 1 , wherein the lateral biopsy arm corresponds to a first plane, the support arm corresponds to a second plane, and the first plane being non-coplanar with the second plane.

12. The lateral biopsy unit of claim 11 , wherein the first plane is parallel to the second plane.

13. The lateral biopsy unit of claim 1 , wherein the lateral biopsy arm is linearly positionable along the support arm along a first axis, wherein the holster is linearly positionable along a second axis different than the first axis, and wherein the lateral biopsy arm is defined by a third axis disposed at an angle to both the first axis and the second axis.

14. The lateral biopsy unit of claim 13 , wherein the support arm extends along the first axis, and the holster extends along the second axis.

15. The lateral biopsy unit of claim 13 , wherein the first axis is orthogonal to the second axis.

16. The lateral biopsy unit of claim 13 , further comprising at least one of the following:

a first guidance module configured to be positioned between the lateral biopsy arm and the support arm,

a second guidance module configured to be positioned between the lateral biopsy arm and the holster mount plate, and

a third guidance module configured to be positioned near one end of the support arm;

wherein the holster is positionable by the adjustment of at least one of the first, second, or third guidance module.

17. A needle breast biopsy system, comprising:

a breast imaging system for imaging a breast; and

a lateral biopsy unit attached to the breast imaging system via a coupling mechanism, the lateral biopsy unit including:

a support arm secured to the breast imaging system;

a lateral biopsy arm securable to the support arm;

a holster mount plate coupled to the lateral biopsy arm; and

a biopsy holster mounted on the holster mount plate;

wherein the lateral biopsy arm is disposed at an angle to both the support arm and the holster to allow lateral access to a breast by a biopsy needle secured to the holster.

18. The needle breast biopsy system of claim 17 , wherein the breast imaging system comprises an X-ray source and an X-ray detector.

19. The needle breast biopsy system of claim 18 , wherein the lateral biopsy unit is configured to be positioned in the view of the breast imaging system.

20. The needle breast biopsy system of claim 19 , wherein the biopsy holster is configured to be positioned parallel to the X-ray detector.

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 Feb 8, 2023
From: DEFREITAS, KENNETH; SHAW, IAN; LAVIOLA, JOHN; PICKETT, KATHLEEN; FAND, AARON; RUTH, CHRISTOPHER; GKANATSIOS, NIKOLAOS A.
To: HOLOGIC, INC.
Reel/Frame 062625/0274 →
Continuity (4)
Continuation 16809355 · Mar 4, 2020
Continuation 12715591 · Mar 2, 2010
Provisional Application 61249772 · Oct 8, 2009
Related Publication 20230225821A1 · Jul 20, 2023
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