# US 11,432,883 B2 · Ultrasound localization system with advanced biopsy site markers

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- Number: US 11,432,883 B2
- Document ID: US11432883B2
- Status: Granted
- Kind: B2
- Application number: 17/510,262
- Filed: 2021-10-25
- Published: 2022-02-10
- Granted: 2022-09-06
- Earliest claimed: 2017-12-11
- Assignees: Hologic, Inc.
- Applicants: Hologic, Inc.
- Inventors: John Laviola; Shawn St. Pierre; Brian Stellmach; Lori Fontaine; Joseph A. Stand, III; Estefania Alvarez; Stephen Grantz; Michelle Dawn Lyman; Shannon Marie Butler; Yuliya Mathis
- Web page: https://patentgrep.com/patent/US11432883B2

## CPC

- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 5/065: {Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe}
- A61B 8/0833: {involving detecting or locating foreign bodies or organic structures}
- A61B 8/0841: {for locating instruments}
- A61B 8/085: {for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules}
- A61B 8/4254: {using sensors mounted on the probe}
- A61B 8/46: {Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient}
- A61B 8/463: {characterised by displaying multiple images or images and diagnostic data on one display}
- A61B 8/481: {involving the use of contrast agents, e.g. microbubbles introduced into the bloodstream}
- A61B 17/3211: Surgical scalpels, knives; Accessories therefor
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- G06T 7/70: Determining position or orientation of objects or cameras (camera calibration G06T7/80)
- A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)}
- A61B 5/4842: {Monitoring progression or stage of a disease}
- A61B 5/6867: {specially adapted to be attached or implanted in a specific body part (A61B5/6847 takes precedence)}
- A61B 8/0825: {for diagnosis of the breast, e.g. mammography}
- A61B 8/485: {involving measuring strain or elastic properties}
- A61B 34/25: {User interfaces for surgical systems}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00893: {pharmaceutically effective}
- A61B 2017/00964: {composite}
- A61B 2018/00595: {Cauterization}
- A61B 2034/2063: {Acoustic tracking systems, e.g. using ultrasound}
- A61B 2034/2065: {Tracking using image or pattern recognition}
- A61B 2090/378: {using ultrasound}
- A61B 2090/3904: {specially adapted for marking specified tissue}
- A61B 2090/3908: {Soft tissue, e.g. breast tissue}
- A61B 2090/3912: {Body cavities}
- A61B 2090/3925: {ultrasonic}
- A61B 2090/3929: {Active markers}
- A61B 2090/395: {with marking agent for marking skin or other tissue}
- A61B 2090/3954: {magnetic, e.g. NMR or MRI}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B 2090/3995: {Multi-modality markers}
- G06T 2207/10132: Ultrasound image
- G06T 2207/20081: Training; Learning
- G06T 2207/30096: Tumor; Lesion
- G06T 2207/30204: Marker
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL

## 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

### Claim 1

A method for localization of an implanted marker with ultrasound technology, the method comprising:
emitting an array of ultrasonic sound waves from an ultrasonic transducer of an ultrasound probe;
detecting reflected ultrasonic sound waves by the ultrasonic transducer, wherein the reflected ultrasonic sound waves include at least a portion of the array of ultrasonic sound waves after being reflected from a marker implanted proximate a lesion within an interior of a patient;
generating image data from the reflected ultrasonic sound waves;
analyzing, by a processor, the generated image data to identify the marker within the interior of the patient;
displaying, on a display, an ultrasound image including the marker based on the reflected ultrasonic sound waves; and
based at least in part on the identification of the marker, emitting an audible sound, wherein the audible sound is based on how close the marker is to a center of a field of view of the ultrasound image displayed on the display.

### Claim 2 (depends on 1)

The method of claim 1, further comprising varying a frequency or an intensity of a tone of the audible sound.

### Claim 3 (depends on 1)

The method of claim 1, wherein prior to the emission of the audible sound, determining, by the processor, at least one of a distance or an orientation to the marker, and wherein the emission of the audible sound is further based on the at least one determined distance or orientation to the marker.

### Claim 4 (depends on 3)

The method of claim 3, further comprising varying a frequency or an intensity of a tone of the audible sound based on the at least one determined distance or orientation to the marker.

### Claim 5 (depends on 3)

The method of claim 3, further comprising guiding an incision instrument to the marker, by the emitted audible sound, based on the at least one determined distance or orientation to the marker.

### Claim 6 (depends on 3)

The method of claim 3, wherein the at least one determined distance or orientation to the marker is one of:
a distance or an orientation from a portion of the ultrasound probe to the marker, or
a distance or an orientation from a portion of an incision instrument to the marker.

### Claim 7 (depends on 6)

The method of claim 6, further comprising indicating an incision point on the patient for the incision instrument based on the distance or the orientation from a portion of the incision instrument to the marker.

### Claim 8 (depends on 6)

The method of claim 6, further comprising indicating, on the display, a vector path towards the marker for the incision instrument based on the distance or the orientation from a portion of the incision instrument to the marker.

### Claim 9 (depends on 3)

The method of claim 3, further comprising displaying, on the display, the at least one determined distance or orientation to the marker.

### Claim 10 (depends on 1)

The method of claim 1, wherein the ultrasound probe emits the audible sound.

### Claim 11

A system for ultrasound localization, the system comprising:
a marker, wherein the marker is configured to be implanted in an interior of a patient;
an ultrasound probe comprising an ultrasonic transducer, the ultrasonic transducer configured to emit an array of ultrasonic sound waves and detect reflected ultrasonic sound waves, wherein the reflected ultrasonic sound waves include at least a portion of the array of ultrasonic sound waves after being reflected from the marker implanted proximate a lesion within the interior of the patient;
at least one output device configured to emit an audible sound, the at least one output device including a display;
at least one processor operatively connected to the at least one output device and the ultrasound probe; 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:
generating image data from the reflected ultrasonic sound waves;
analyzing, by the at least one processor, the generated image data to identify the marker within the interior of the patient;
displaying, on the display, an ultrasound image including the marker based on the reflected ultrasonic sound waves; and
based at least in part on the identification of the marker, emitting an audible sound via the at least one output device, wherein the audible sound is based on how close the marker is to a center of a field of view of the ultrasound image displayed on the display.

### Claim 12 (depends on 11)

The system of claim 11, wherein the at least one processor varies a frequency or an intensity of a tone of the audible sound emitted from the at least one output device.

### Claim 13 (depends on 11)

The system of claim 11, wherein the set of operations that the at least one processor performs further comprises, prior to the emission of the audible sound, determining at least one of a distance or an orientation to the marker, and wherein the emission of the audible sound from the at least one output device is further based on the at least one determined distance or orientation to the marker.

### Claim 14 (depends on 13)

The system of claim 13, wherein the at least one processor varies a frequency or an intensity of a tone of the audible sound based on the at least one determined distance or orientation to the marker.

### Claim 15 (depends on 13)

The system of claim 13, further comprising an incision instrument configured for use within the interior of the patient, wherein the set of operations that the at least one processor performs further comprises guiding the incision instrument to the marker, by the emitted audible sound, based on the at least one determined distance or orientation to the marker.

### Claim 16 (depends on 13)

The system of claim 13, further comprising an incision instrument configured for use within the interior of the patient, and wherein the at least one determined distance or orientation to the marker is one of:
a distance or an orientation from a portion of the ultrasound probe to the marker, or
a distance or an orientation from a portion of the incision instrument to the marker.

### Claim 17 (depends on 16)

The system of claim 16, wherein the set of operations that the at least one processor performs further comprises indicating an incision point on the patient for the incision instrument based on the distance or the orientation from a portion of the incision instrument to the marker.

### Claim 18 (depends on 16)

The system of claim 16, wherein the set of operations that the at least one processor performs further comprises indicating, on the display, a vector path towards the marker for the incision instrument based on the distance or the orientation from a portion of the incision instrument to the marker.

### Claim 19 (depends on 13)

The system of claim 13, wherein the display is configured to indicate the at least one determined distance or orientation to the marker.

### Claim 20 (depends on 11)

The system of claim 11, wherein the ultrasound probe comprises the at least one output device.

### Claim 21 (depends on 11)

The system of claim 11, wherein the marker is a radial-spoke marker, a multi-layered marker, or a fibrous polymer marker having at least an ultrasound activated contrasting agent.