Ultrasound localization system with advanced biopsy site markers

Patent metadata

Field	Value
Publication number	US-12029503-B2
Application number	US-202117557773-A
Country	US
Kind code	B2
Filing date	Dec 21, 2021
Priority date	Dec 11, 2017
Publication date	Jul 9, 2024
Grant date	Jul 9, 2024

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.

First claim

What is claimed is:

1. A system for ultrasound localization, the system comprising:
a marker comprising a central core formed from a first material and at least a first layer formed from a second material at least partially surrounding the central core, wherein the first material has a higher echogenicity than the second material, wherein the marker is configured to be implanted within an interior of a patient;
an ultrasound probe comprising an ultrasonic transducer, the ultrasonic transducer configured to emit ultrasonic sound waves and detect reflected ultrasonic sound waves;
a display;
at least one processor operatively connected to 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 first image data from first reflected ultrasonic sound waves reflected from the at least the first layer of the marker when implanted proximate a lesion within the interior of the patient when the ultrasound probe is at a first position;
analyzing the generated first image data to identify the marker within the interior of the patient;
generating second image data from second reflected ultrasonic sound waves reflected from within the interior of the patient when the ultrasound probe is at a second position;
analyzing 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;
displaying the navigation indicator on the display with an ultrasound image generated from the second image data;
based at least in part on the identification of the marker, determining a distance to at least one of the marker or the lesion from the ultrasound probe in the second position; and
displaying the determined distance to the at least one of the marker or the lesion on the display.

2. The system of claim 1 , wherein the central core of the marker is radiopaque.

3. The system of claim 1 , wherein the at least the first layer of the marker is configured to be activated by ultrasonic sound waves and break off from the central core, and wherein the operation of analyzing the generated first image data to identify the marker within the interior of the patient that the at least one processor performs further includes detecting a scattering of ultrasonic sound waves from the break off of the at least the first layer.

4. The system of claim 1 , wherein the at least the first layer of the marker comprises two or more layers, each of the two or more layers having a distinct echogenic profile.

5. The system of claim 4 , wherein each of the two or more layers have different thicknesses, and wherein the set of operations that the at least one processor performs further comprises evaluating the lesion based on an identified layer of the marker.

6. The system of claim 4 , wherein each of the two or more layers have different time periods of degradation.

7. The system of claim 1 , wherein the operation of analyzing the generated first image data to identify the marker within the interior of the patient that the at least one processor performs further includes analyzing, by a machine learning image classifier, the generated first image data to identify the marker within the interior of the patient.

8. The system of claim 7 , wherein the machine learning image classifier is a classifier that has been trained using echogenicity grades.

9. The system of claim 1 , wherein the set of operations that the at least one processor performs further comprises receiving, from a system user, an input having identifying information of the marker for use in identifying the marker in the generated first image data.

10. The system of claim 9 , wherein the identifying information of the marker includes one or more of a type of marker, a shape of marker, and a size of marker.

11. A method for ultrasonically locating an implanted marker with an ultrasound probe, the marker including a central core formed from a first material and at least a first layer formed from a second material at least partially surrounding the central core, wherein the first material has a higher echogenicity than the second material, the method comprising:
providing the marker, wherein the marker is implanted proximate a lesion within an interior of a patient;
emitting a first array of ultrasonic sound waves from an ultrasonic transducer of the 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 emitted first array of ultrasonic sound waves after being reflected from the at least the first layer of the marker;
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 emitted second array of ultrasonic sound waves after be 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;
displaying the navigation indicator on a display operatively connected to the processor with an ultrasound image generated form from the second image data;
based at least in part on the identification of the marker, determining, by the processor, a distance to at least one of the marker or the lesion from the ultrasound probe in the second position; and
displaying, on the display, the determined distance to the at least one of the marker or the lesion.

12. The method of claim 11 , wherein the first array of ultrasonic sound waves activate the at least the first layer of the marker and cause at least a portion of the at least the first layer to break off from the central core.

13. The method of claim 12 , wherein analyzing, by the processor, the generated first image data to identify the marker within the interior of the patient further includes detecting a scattering of ultrasonic sound waves from the break off of the at least a portion of the at least the first layer.

14. The method of claim 11 , further comprising evaluating lesion changes based on a size of the marker.

15. The method of claim 14 , wherein the at least the first layer of the marker comprises two or more layers, each of the two or more layers having a distinct echogenic profile and different thicknesses, and the evaluation of the lesion is based on an identified layer of the marker.

16. The method of claim 14 , wherein the at least the first layer of the marker comprises two or more layers, each of the two or more layers having a distinct echogenic profile and different time periods of degradation, and the evaluation of the lesion is based on an identified layer of the marker.

17. The method of claim 11 , wherein the

Assignees

• Hologic Inc

Inventors

• Laviola John
• St Pierre Shawn
• Stellmach Brian
• Fontaine Lori
• Stand Iii Joseph A
• Alvarez Estefania
• Grantz Stephen
• Lyman Michelle Dawn
• Butler Shannon Marie
• Mathis Yuliya

Classifications

• A61B2018/00595

  Cauterization · CPC title

• A61B17/3211

  Surgical scalpels, knives; Accessories therefor · CPC title

• A61B8/481

  involving the use of contrast agents, e.g. microbubbles introduced into the bloodstream · CPC title

• A61B2090/395

  with marking agent for marking skin or other tissue · CPC title

• A61B2090/3904

  specially adapted for marking specified tissue · CPC title