IP Library Granted Patent US 11,234,772
Granted Patent B2
US 11,234,772 · App. 16/771,379 · Granted Feb 1, 2022

Ultrasound localization system with advanced biopsy site markers

Inventors: John Laviola (Marlborough, MA); Shawn St. Pierre (Marlborough, MA); Brian Stellmach (Marlborough, MA); Lori Fontaine (Marlborough, MA); Joseph A. Stand, III (Marlborough, MA); Estefania Alvarez (Marlborough, MA); Stephen Grantz (Marlborough, MA); Michelle Dawn Lyman (Marlborough, MA); Shannon Marie Butler (Marlborough, MA); Yuliya Mathis (Marlborough, MA)
Assignee: Hologic, Inc.
A61B34/20A61B5/065A61B8/085A61B8/0841A61B8/463A61B8/481A61B17/3211A61B90/39G06T7/70A61B2018/00595A61B2034/2063A61B2090/3904A61B2090/395A61B2090/3925G06T2207/10132G06T2207/30096G06T2207/30204
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Quick Facts
Patent No.
US 11,234,772
App. No.
16/771,379
Granted
Feb 1, 2022
Kind
B2
Abstract

Disclosed biopsy markers are adapted to serve as localization markers during a surgical procedure. Adaptation includes incorporation of materials detectable under ultrasound during surgery, as well as features for co-registration with image guidance or other real-time imaging technologies during surgery. Such biopsy markers, when used as localization markers, improve patient comfort and reduce challenges in surgical coordination and surgery time. Additional disclosed biopsy markers are adapted to serve as monitoring and/or detection apparatuses. Localization of an implanted marker may be done with ultrasound technology. Ultrasound image data is analyzed to identify the implanted marker. A distance to the marker or a lesion may be determined and displayed. The determined distance may be a distance between the ultrasound probe and the marker or lesion, a distance between the marker or lesion and an incision instrument, and/or a distance between the ultrasound probe and the incision instrument.

Claims (33)

1. A method for localization of an implanted marker with ultrasound technology, the method comprising:

emitting a first array of ultrasonic sound waves from an ultrasonic transducer of an ultrasound probe in a first position;

detecting first reflected ultrasonic sound waves by the ultrasonic transducer, wherein the first reflected ultrasonic sound waves include at least a portion of the first array of ultrasonic sound waves after being reflected from a marker implanted within an interior of a patient;

generating first image data from the first reflected ultrasonic sound waves;

analyzing, by a processor, the generated first image data to identify the marker within the interior of the patient;

emitting a second array of ultrasonic sound waves from the ultrasonic transducer of the ultrasound probe in a second position;

detecting second reflected ultrasonic sound waves by the ultrasonic transducer, wherein the second reflected ultrasonic sound waves include at least a portion of the second array of ultrasonic sound waves after being reflected from within the interior of the patient;

generating second image data from the second reflected ultrasonic sound waves;

analyzing, by the processor, the generated second image data to determine the marker is not present within the generated second image data;

generating a navigation indicator, wherein the navigation indicator indicates a direction of the marker relative to the second position of the ultrasound probe; and

displaying the navigation indicator on a display concurrently with an ultrasound image generated from the second image data.

2. The method of claim 1 , further comprising:

generating a first image from the first image data; and

displaying the first image on the display.

3. The method of claim 2 , further comprising:

based at least in part on the identification of the marker in the generated first image data, determining a distance to the marker within the interior of the patient; and

displaying on the display, concurrently with the display of the first image, the determined distance to the marker.

4. The method of claim 3 , wherein the determined distance to the marker is one of: a distance from a portion of the ultrasound probe to the marker, a distance from a portion of a scalpel to the marker, or a distance from a portion of a cautery tool to the marker.

5. The method of claim 1 , wherein the navigation indicator is an arrow pointing in the direction of the marker relative to the second position of the ultrasound probe.

6. A method for localization of an implanted marker with ultrasound technology, the method comprising:

emitting a first array of ultrasonic sound waves from an ultrasonic transducer of an ultrasound probe in a first position;

detecting first reflected ultrasonic sound waves by the ultrasonic transducer, wherein the first reflected ultrasonic sound waves include at least a portion of the first array of ultrasonic sound waves after being reflected from a marker implanted within an interior of a patient;

generating first image data from the first reflected ultrasonic sound waves;

analyzing, by a processor, the generated first image data to identify the marker within the interior of the patient;

based at least in part on the identification of the marker in the generated first image data, determining a distance to the marker within the interior of the patient;

displaying on a display, concurrently with display of a first image generated from the first image data, the determined distance to the marker;

emitting a second array of ultrasonic sound waves from the ultrasonic transducer of the ultrasound probe in a second position;

detecting second reflected ultrasonic sound waves by the ultrasonic transducer, wherein the second reflected ultrasonic sound waves include at least a portion of the second array of ultrasonic sound waves after being reflected from within the interior of the patient;

generating second image data from the second reflected ultrasonic sound waves;

analyzing, by the processor, the generated second image data to determine the marker is not present within the generated second image data;

generating a navigation indicator, wherein the navigation indicator indicates a direction of the marker relative to the second position of the ultrasound probe; and

displaying the navigation indicator on the display concurrently with an ultrasound image generated from the second image data, wherein the navigation indicator is an arrow pointing in the direction of the marker relative to the second position of the ultrasound probe.

7. The method of claim 6 , wherein the determined distance to the marker is one of: a distance from a portion of the ultrasound probe to the marker, a distance from a portion of a scalpel to the marker, or a distance from a portion of a cautery tool to the marker.

Assignments (6)
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 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 30, 2022
From: ST. PIERRE, SHAWN
To: HOLOGIC, INC.
Reel/Frame 061923/0350 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 13, 2021
From: ST. PIERRE, SHAWN
To: HOLOGIC, INC.
Reel/Frame 058375/0168 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 24, 2021
From: LAVIOLA, JOHN; STELLMACH, BRIAN; FONTAINE, LORI; STAND, JOSEPH A., III; ALVAREZ, ESTEFANIA; GRANTZ, STEPHEN; LYMAN, MICHELLE DAWN; BUTLER, SHANNON MARIE; MATHIS, YULIYA
To: HOLOGIC, INC.
Reel/Frame 057270/0489 →
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 →