Granted Patent B2

US 12,433,692 · App. 18/731,573 · Granted Oct 7, 2025

Inventors: Shawn St. Pierre (The Hills, TX); Stephen Grantz (Pelham, NH); Thomas Fisk (Newton, MA); Mark Guetersloh (Bedford, MA)

Assignee: Hologic, Inc.

A61B34/20A61B8/0841A61B8/4488A61B8/463A61B8/485A61B8/5215A61B10/0275A61B17/3403A61B34/25A61B90/39G01S7/52073G01S15/8906G06N20/00G16H10/40G16H20/40G16H30/40G16H40/63A61B8/0825A61B8/481A61B2017/3413A61B2034/2063A61B2034/2065A61B2090/378A61B2090/3925A61B2090/3983

Abstract

Claims (43)

1. A method for providing guidance for operation of a needle having an inner member having a sharp tip configured to extend from the needle, 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 an interior of a patient and the needle within the interior of the patient;

generating image data from the reflected ultrasonic sound waves;

identifying, by a processor, within the generated image data, at least a portion of the needle within the interior of the patient;

based at least in part on the identification of the portion of the needle, determining, by the processor, a predicted location of the inner member of the needle based at least in part on one or more needle properties stored in memory operatively connected to the processor, the needle properties comprising at least one of a needle length, a needle size, a needle wall thickness, a needle material composition, a needle geometry, and a needle extension mechanism;

displaying, on a display operatively connected to the processor, an ultrasound image based on the generated image data;

determining a deflection probability for an extended inner member location based on at least one of: (1) experimental data for a type of the needle, and (2) the one or more stored properties of the needle; and

displaying a deflection probability indicator on the ultrasound image, wherein the deflection probability indicator indicates a range for the extended inner member location based on the determined deflection probability, wherein the deflection probability indicator depicts a probability distribution for the extended inner member location, and wherein the deflection probability indicator is based at least in part on a standard deviation of the extended inner member location.

2. The method of claim 1 , wherein identifying at least a portion of the needle includes identifying the needle in a pre-extended configuration, and the predicted location of the inner member of the needle is a predicted location of the inner member in a post-extended configuration.

3. The method of claim 1 , further comprising displaying at least one indicator for the predicted location of the inner member of the needle that includes displaying at least one of a tip indicator indicating a predicted tip location or an aperture indicator indicating a predicted aperture location.

4. The method of claim 1 , wherein identifying at least a portion of the needle comprises receiving a user input identifying the needle in the ultrasound image.

5. The method of claim 1 , wherein identifying at least a portion the needle comprises analyzing, by the processor, the generated image data by image analysis techniques to identify the needle.

6. The method of claim 1 , wherein determining the deflection probability is further based on tissue properties of the interior of the patient along an extension trajectory for the needle.

7. The method of claim 6 , wherein the tissue properties are based on an input identifying the tissue properties.

8. The method of claim 6 , further comprising determining the tissue properties by:

determining, by the processor, the extension trajectory for the needle based on the generated image data;

receiving elastography data for tissue along at least a portion of the extension trajectory for the needle; and

determining the tissue properties based on the received elastography data.

9. The method of claim 1 , further comprising:

determining that the needle has diverted out of an imaging plane of the ultrasound image; and

in response to determining that the needle has diverted out of the imaging plane for the ultrasound image, performing at least one of the following operations:

displaying an alert indicating that the needle has diverted out of the imaging plane for the ultrasound image; or

altering a beamform emitted from the ultrasound probe to compensate for the needle diversion out of the imaging plane.

10. The method of claim 9 , wherein determining that the needle has diverted out of the imaging plane for the ultrasound image further comprises:

determining a first apparent depth for the needle at a first time;

determining a second apparent depth for the needle at a second time subsequent to the first time, the second apparent depth being greater than the first apparent depth;

determining a third apparent depth for the needle at a third time subsequent to the second time, the third apparent depth being less than the second apparent depth; and

based on the third apparent depth being less than the second apparent depth and the second apparent depth being greater than the first apparent depth, determining that the needle has diverted out of the imaging plane for the ultrasound image.

11. The method of claim 1 , wherein the method further comprises obtaining the experimental data for the needle.

12. The method of claim 11 , wherein obtaining the experimental data comprises one of:

passing the inner member through dense tissue and passing the inner member through adipose tissue; and

inserting the needle in a replica of a breast.

13. The method of claim 1 , wherein the deflection probability indicator depicts a likelihood of the extended inner member location.

14. The method of claim 1 , wherein the deflection probability indicator comprises a heatmap.

15. The method of claim 1 , further comprising overlaying the deflection probability indicator on the ultrasound image.

16. The method of claim 1 , further comprising providing the needle, the needle being a biopsy needle and the inner member being an inner cannula.

17. The method of claim 1 , wherein the deflection probability indicator is one of an ellipse, a rectangle, a square, a triangle, or a circle.

18. The method of claim 1 , further comprising:

determining a maximum pre-extended needle depth for which a predicted post-extended inner member location remains within the ultrasound image; and

displaying a maximum needle depth indicator, wherein the maximum needle depth indicator indicates the determined maximum pre-extended needle depth.

19. The method of claim 18 , wherein the maximum needle depth indicator is a line segment perpendicular to an extension trajectory of the needle.

20. The method of claim 1 , further comprising displaying a tip indicator, the tip indicator a graphical element having a shape based on a geometry of the sharp tip of the inner member of the needle.

Assignments (4)

Continuity (3)

References Cited (250)