IP Library Granted Patent US 10,595,954
Granted Patent B2
US 10,595,954 · App. 12/715,591 · Granted Mar 24, 2020

Needle breast biopsy system and method for 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); Ruth Christopher (Boxford, MA)
Assignee: Hologic, Inc.
A61B90/17A61B10/0233A61B90/11A61B6/502A61B2017/3409A61B2090/376
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Quick Facts
Patent No.
US 10,595,954
App. No.
12/715,591
Granted
Mar 24, 2020
Kind
B2
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 (27)

1. An upright x-ray mammography imaging system comprising:

a gantry;

an x-ray tube configured to rotate relative to the gantry over an angular range, wherein the x-ray tube emits x-rays within a field;

an x-ray receptor configured to rotate relative to the gantry and disposed in a plane normal to the x-ray tube so as to receive the emitted x-rays;

a compression platform connected to the gantry and encasing the x-ray receptor;

a compression paddle spaced apart from each of the x-ray tube and the compression platform, wherein the compression paddle and the compression platform are configured to compress a breast of a patient, and wherein the compression paddle is releasably fittable onto the gantry; and

a needle biopsy assembly releasably couplable to the gantry between the x-ray tube and the compression platform, wherein the needle biopsy assembly is removable from the gantry separate from the compression paddle, the needle biopsy assembly comprising:

a first handle and a second handle, wherein at least one of the first handle and the second handle comprises a coupling mechanism to releasably couple the needle biopsy assembly to the gantry;

a support structure extending between the first handle and the second handle;

a fixed support arm coupled to the support structure;

an angular support arm coupled to the fixed support arm, wherein the angular support arm extends at an angle offset from the plane of the x-ray receptor;

a holster mount moveably coupled to the angular support arm;

a biopsy device coupled to the holster mount wherein the holster mount is adapted to position the biopsy device proximate a target location, the biopsy device comprising a needle, wherein a portion of the needle is positionable so as to be disposed at the angle offset between the compression platform and the compression paddle to biopsy the compressed breast, and wherein when the needle biopsy assembly is coupled to the gantry, the holster mount and the biopsy device are positioned outside of the field of x-rays emitted by the x-ray tube so that image artifacts by the holster mount and the biopsy device are not formed in an x-ray image; and

a needle support coupled to the angular support arm for stabilizing an end of the needle.

2. The x-ray imaging system of claim 1 wherein x-ray image data acquired by the x-ray image system is used to determine coordinates of the target location for positioning the biopsy device.

3. The x-ray imaging system of claim 2 wherein the x-ray image data comprises two dimensional image data.

4. The x-ray imaging system of claim 3 wherein the two dimensional image data includes at least one of a scout image, a mammogram, a stereotactic image and a tomosynthesis projection image.

5. The x-ray imaging system of claim 2 wherein the x-ray image data comprises three dimensional image data.

6. The x-ray imaging system of claim 5 wherein the three dimensional image data includes stereotactic volume data and tomosynthesis reconstruction data.

7. The x-ray imaging system of claim 2 wherein the x-ray image data comprises a combination of two dimensional and three dimensional image data.

8. The x-ray imaging system of claim 1 wherein the holster mount is configured to be manually advanced along the angular support arm.

9. The x-ray imaging system of claim 1 wherein the angle between the fixed support and the angular support arm is adjustable.

10. The x-ray imaging system of claim 1 further comprising a control unit.

11. The x-ray imaging system of claim 10 wherein the control unit includes a display for displaying information associated with a position of the biopsy device coupled to the angular support arm.

12. The x-ray imaging system of claim 11 wherein the information includes information associated with a type of biopsy device coupled to the angular support arm.

13. The x-ray imaging system of claim 1 further comprising a lateral biopsy arm, couplable to the assembly, for supporting a biopsy needle during lateral biopsies.

14. The x-ray imaging system of claim 1 wherein the needle is configured to be positioned in a cranial-caudal orientation over the breast.

Assignments (10)
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 054089/0804 Recorded Apr 28, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC., ON ITS OWN BEHALF AND AS SUCCESSOR-BY-MERGER TO FOCAL THERAPEUTICS, INC.; GEN-PROBE INCORPORATED; FAXITRON BIOPTICS, LLC; GEN-PROBE PRODESSE, INC.
Reel/Frame 075504/0575 →
RELEASE OF SECURITY INTEREST Recorded Apr 28, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC., ON ITS OWN BEHALF AND AS SUCCESSOR-BY-MERGER TO DIRECT RADIOGRAPHY CORP.; CYTYC CORPORATION, ON ITS OWN BEHALF AND AS SUCCESSOR-BY-MERGER TO BIOLUCENT, LLC; CYTYC SURGICAL PRODUCTS, LLC, AS SUCCESSOR-BY-CONVERSION TO CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; GEN-PROBE INCORPORATED, ON ITS OWN BEHALF AND AS SUCCESSOR-BY-MERGER TO THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE PRODESSE, INC.; SUROS SURGICAL SYSTEMS, INC.
Reel/Frame 075566/0039 →
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 Oct 15, 2020
From: HOLOGIC, INC.; FAXITRON BIOPTICS, LLC; FOCAL THERAPEUTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 054089/0804 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT PATENT NO. 8081301 PREVIOUSLY RECORDED AT REEL: 028810 FRAME: 0745. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY AGREEMENT. Recorded Nov 9, 2017
From: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE INCORPORATED
To: GOLDMAN SACHS BANK USA
Reel/Frame 044432/0565 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT PATENT NO. 8081301 PREVIOUSLY RECORDED AT REEL: 035820 FRAME: 0239. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST RELEASE. Recorded Nov 9, 2017
From: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
To: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE INCORPORATED
Reel/Frame 044727/0529 →
SECURITY AGREEMENT Recorded Aug 7, 2015
From: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; DIRECT RADIOGRAPHY CORP.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 036307/0199 →
SECURITY INTEREST RELEASE REEL/FRAME 028810/0745 Recorded Jun 4, 2015
From: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
To: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE INCORPORATED
Reel/Frame 035820/0239 →
SECURITY AGREEMENT Recorded Aug 1, 2012
From: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE INCORPORATED
To: GOLDMAN SACHS BANK USA
Reel/Frame 028810/0745 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 30, 2010
From: DEFREITAS, KENNETH; SHAW, IAN; LAVIOLA, JOHN; PICKETT, KATHLEEN; FAND, AARON; RUTH, CHRISTOPHER; GKANASTSIOS, NIKOLAOS A.
To: HOLOGIC, INC.
Reel/Frame 024162/0547 →
Cited By (3)
US 12,564,365 US 12,664,656 US 12,672,778