IP Library Granted Patent US 12708454
Granted Patent B2
US 12708454 · App. 18/894,258 · Granted Aug 18, 2026

Ultrasound localization system with advanced biopsy site markers

Inventors: John Laviola (Madison, CT); Shawn St. Pierre (The Hills, TX); Brian Stellmach (Marlborough, MA); Lori Fontaine (Marlborough, MA); Joseph A. Stand, III (Holden, MA); Estefania Alvarez (Marlborough, MA); Stephen Grantz (Pelham, NH); Michelle Dawn Lyman (Framingham, MA); Shannon Marie Butler (Marlborough, MA); Yuliya Mathis (Framingham, MA)
Assignee: Hologic, Inc.
A61B34/20A61B5/065A61B8/0841A61B8/085A61B8/4254A61B8/46A61B8/463A61B8/481A61B17/3211A61B90/39G06T7/70A61B5/14503A61B5/4842A61B8/0825A61B2017/00867A61B2017/00964A61B2018/00595A61B2034/2063A61B2034/2065A61B34/25A61B2090/378A61B2090/3904A61B2090/3908A61B2090/3912A61B2090/3925A61B2090/395A61B2090/3995G06T2207/10132G06T2207/20081G06T2207/30096G06T2207/30204
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Quick Facts
Patent No.
US 12708454
App. No.
18/894,258
Granted
Aug 18, 2026
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 (52)

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

acquiring an ultrasound image via an ultrasound probe of the marker implanted proximate a lesion within an interior of a patient;

displaying the ultrasound image on a display, wherein the ultrasound image includes the implanted marker;

analyzing image data of the ultrasound image to identify the marker in the ultrasound image;

receiving input regarding a type of an incision instrument;

analyzing image data of the ultrasound image to identify the incision instrument in the ultrasound image based on the input of the type of the incision instrument;

based on the identification of the marker and the identification of the incision instrument in the ultrasound image, determining a distance, from the image data, between the marker and the incision instrument; and

displaying the determined distance on the ultrasound image along with the marker and the incision instrument.

2 . The method of claim 1 , wherein the input is received from a user interface presented on the display that displays the ultrasound image.

3 . The method of claim 1 , further comprising, based on the input, obtaining dimensional information of the incision instrument.

4 . The method of claim 1 , wherein determining the distance between the marker and the incision instrument comprises:

determining a marker depth between the ultrasound probe and the marker based on the image data;

determining an instrument depth between the ultrasound probe and at least a portion of the incision instrument based on the image data; and

calculating the distance between the marker and the incision instrument.

5 . The method of claim 1 , wherein determining the distance between the marker and the incision instrument is based on space between the marker and the incision instrument and the distance determination is trained on samples or phantoms having markings with known distances.

6 . The method of claim 1 , further comprising:

receiving a signal from an instrument transceiver attached to the incision instrument; and

processing the signal received from the instrument transceiver to determine an orientation of the incision instrument; and

determining alignment of the incision instrument relative to an axis of the marker.

7 . The method of claim 6 , further comprising, based on the determined distance, determining a deviation of the incision instrument from an incision path.

8 . The method of claim 1 , further comprising receiving a second input regarding a type of the marker, and wherein the identification of the marker in the ultrasound image is based on the second input of the type of the marker.

9 . The method of claim 1 , wherein the incision instrument includes a cautery tool, a scalpel, an internal probe, or a temperature probe.

10 . The method of claim 1 , further comprising activating the marker via ultrasonic sound waves via the ultrasound probe.

11 . A system for ultrasound localization, the system comprising:

a marker configured to be implanted proximate a lesion within an interior of a patient;

an ultrasound probe;

an incision instrument;

a display;

at least one processor operatively connected to the ultrasound probe and the display; and

memory, operatively connected to the at least one processor, storing instructions that when executed by the at least one processor perform a set of operations comprising:

acquiring an ultrasound image via the ultrasound probe of the marker;

displaying the ultrasound image on the display, wherein the ultrasound image includes the marker;

analyzing image data of the ultrasound image to identify the marker in the ultrasound image;

receiving input regarding a type of the incision instrument;

analyzing image data of the ultrasound image to identify the incision instrument in the ultrasound image based on the input of the type of the incision instrument;

based on the identification of the marker and the identification of the incision instrument in the ultrasound image, determining a distance, from the image data, between the marker and the incision instrument; and

displaying the determined distance on the ultrasound image along with the marker and the incision instrument.

12 . The system of claim 11 , wherein the set of operations that the at least one processor performs further comprises receiving the input from a user interface presented on the display that displays the ultrasound image.

13 . The system of claim 11 , wherein the set of operations that the at least one processor performs further comprises, based on the input, obtaining dimensional information of the incision instrument.

14 . The system of claim 11 , wherein within the set of operations that the at least one processor performs, determining the distance between the marker and the incision instrument comprises:

determining a marker depth between the ultrasound probe and the marker based on the image data;

determining an instrument depth between the ultrasound probe and at least a portion of the incision instrument based on the image data; and

calculating the distance between the marker and the incision instrument.

15 . The system of claim 11 , within the set of operations that the at least one processor performs, determining the distance between the marker and the incision instrument is based on space between the marker and the incision instrument and the distance determination is trained on samples or phantoms having markings with known distances.

16 . The system of claim 11 , further comprising an instrument transceiver attached to the incision instrument and operatively connected to the at least one processor, wherein the set of operations that the at least one processor performs further comprises:

receiving a signal from the instrument transceiver; and

processing the signal received from the instrument transceiver to determine an orientation of the incision instrument; and

determining alignment of the incision instrument relative to an axis of the marker.

17 . The system of claim 16 , wherein the set of operations that the at least one processor performs further comprises, based on the determined distance, determining a deviation of the incision instrument from an incision path.

18 . The system of claim 11 , wherein the set of operations that the at least one processor performs further comprises receiving a second input regarding a type of the marker, and wherein the identification of the marker in the ultrasound image is based on the second input of the type of the marker.

19 . The system of claim 11 , wherein the incision instrument includes a cautery tool, a scalpel, an internal probe, or a temperature probe.

20 . The system of claim 11 , wherein the marker is configured to monitor changes in the lesion.