Breast biopsy and needle localization using tomosynthesis systems

• US 20080045833A1
• Filed: 02/15/2007
• Published: 02/21/2008
• Est. Priority Date: 02/15/2006
• Status: Active Grant

• Current Assignee: Hologic Incorporated
• Original Assignee: Hologic Incorporated
• Inventors: Miller, Michael, Wu, Tao, Mark, Joseph, Laviola, John, Shaw, Ian, Stein, Jay, Smith, Andrew, Niklason, Loren, Defreitas, Kenneth
• Granted Patent: US 8,532,745 B2
• Time in Patent Office: Days
• US Class Current: 600/429
• CPC Class Codes: A61B 10/0041 Detection of breast cancer mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 6/025 Tomosynthesis
• CPC Class Codes: A61B 6/0414 with compression means
• CPC Class Codes: A61B 6/0435 with means for imaging suspended breasts
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/463 characterised by displaying multiple images or images and diagnostic data on one display
• CPC Class Codes: A61B 6/466 adapted to display 3D data
• CPC Class Codes: A61B 6/467 characterised by special input means
• CPC Class Codes: A61B 6/469 for selecting a region of interest [ROI]
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61B 6/502 for diagnosis of breast, i.e. mammography
• CPC Class Codes: A61B 6/542 involving control of exposure
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/17 for soft tissue, e.g. breast-holding devices

Abstract

Methods, devices, apparatuses and systems are disclosed for performing mammography, such as utilizing tomosynthesis in combination with breast biopsy.

Claims

1. A system for facilitating biopsy needle localization utilizing tomosynthesis imaging of a patient'"'"'s breast comprising:

an x-ray source;

tomosynthesis image reconstruction means, including x-ray image receptor, configured to reconstruct tomosynthesis images of the patient'"'"'s breast based on x-rays received by said x-ray image receptor from said x-ray source and passed through the patient'"'"'s breast during tomosynthesis scans;

user interface configured to display said tomosynthesis images, receive identification of an area of interest in the patient'"'"'s breast, and determine three-dimensional coordinates of the identified area of interest; and

a tomosynthesis controller configured to control said x-ray source and x-ray image receptor for said tomosynthesis scans;

a needle assembly including a biopsy needle,

wherein said biopsy needle is positioned based on said three-dimensional coordinates of said area of interest.

2. The system of claim 1, wherein said tomosynthesis controller controls said x-ray source and x-ray image receptor to perform a plurality of additional tomosynthesis scans at respective angles, and for each of said additional tomosynthesis scans at the respective angles, the needle assembly is positioned to avoid casting a shadow in said area of interest during said tomosynthesis scans.

3. The system of claim 1, wherein said identification of the area of interest in the patient'"'"'s breast is recorded as a mark on the tomosynthesis images, and the mark is automatically placed at a corresponding location on one or more subsequent images of the patient'"'"'s breast.

4. The system of claim 1, wherein said tomosynthesis controller controls said x-ray source and tomosynthesis image reconstruction means to obtain one or more pre-fire images of the patient'"'"'s breast for verifying needle location relative to said area of interest, prior to firing of said biopsy needle.

5. The system of claim 1, wherein said tomosynthesis controller controls said x-ray source and tomosynthesis image reconstruction means to obtain a post-fire image for verifying proper needle location, after firing of said biopsy needle and before tissue of the patient'"'"'s breast is sampled.

6. The system of claim 1, wherein the biopsy needle is substantially radiolucent, with the needle tip being radio-opaque.

7. The system of claim 1, wherein the needle assembly further includes an introducer, and the introducer is radiolucent, with a radio opaque band at a distant end of the introducer.

8. The system of claim 1, wherein a body of the needle assembly is radiolucent, with the needle tip being radio-opaque.

9. The system of claim 1 further comprising:

a positioning device coupled to said needle assembly to move said needle assembly; and

a biopsy controller,

wherein said positioning device is motorized, and said biopsy controller controls said motorized positioning device to move said needle assembly to a specific position based on said three-dimensional coordinates determined by said user interface.

10. The system of claim 9, wherein said biopsy controller controls said motorized positioning device to move said needle assembly prior to an initial one of said tomosynthesis scans, to a non-interfering position where the needle assembly does not cast a shadow in said area of interest during said tomosynthesis scans.

11. The system of claim 1, wherein said three-dimensional coordinates of said area of interest is displayed via said user interface, and needle tip coordinates are dynamically displaying via said user interface as the biopsy needle is manually positioned.

12. The system of claim 1 further comprising:

a positioning device coupled to said needle assembly to move said needle assembly,

wherein an operator manually positions the needle assembly utilizing the positioning device.

13. The system of claim 12 further comprising:

a positioning device coupled to said needle assembly to move said needle assembly; and

a hand-operated device coupled mechanically or electrically to said positioning device,

wherein an operator manually operates said hand-operated device to control the positioning device to position the needle assembly.

14. The system of claim 1 further comprising:

a collection chamber configured to collect samples obtained by the biopsy needle; and

an automated calcification detector in a sample delivery path between said biopsy needle and said collection chamber,

wherein said automated calcification detector determines whether the samples include calcifications.

15. The system of claim 14, wherein said automated calcification detector estimates an amount of said calcifications.

16. The system of claim 1 further comprising:

an additional line coupled to the needle assembly for introducing anesthetic and/or contrast agents,

wherein the introduction of the anesthetic and/or contrast agents is synchronized to the imaging sequence.

17. The system of claim 1, wherein the image reconstruction is performed using filtered back projection.

18. The system of claim 1, wherein the image reconstruction uses artifact reduction methods.

19. A method for needle localization for breast biopsy, said method comprising the steps of:

(a) performing tomosynthesis scans of a patient'"'"'s breast, and obtaining data from said tomosynthesis scans;

(b) displaying tomosynthesis images of the patient'"'"'s breast based on said data obtained in step (a);

(c) receiving an indication on said tomosynthesis images of an area of interest in said patient'"'"'s breast, and determining three-dimensional coordinates of said area of interest;

(d) positioning a biopsy needle based on said three-dimensional coordinates of said area of interest determined in step (c).

20. The method of claim 19, further comprising:

positioning said biopsy needle prior to step (a) at a non-interfering position where the biopsy needle does not cast a shadow in said area of interest during said tomosynthesis scans.

21. The method of claim 20, further comprising:

positioning said biopsy needle with a motorized stage prior to step (a), in order to avoid casting a shadow in said area of interest during said tomosynthesis scans.

22. The method of claim 19, further comprising:

(e) inserting said biopsy needle into the patient'"'"'s breast after step (d);

(f) applying X-ray exposures to obtain one or more pre-fire images of the patient'"'"'s breast for verifying needle location relative to said area of interest determined in step (e);

(g) firing said biopsy needle, after verifying the needle location using the one or more X-ray images obtained in step (f); and

(h) applying at least one additional exposure and obtaining a post-fire image for verifying proper needle location, after step (g) and before tissue of the patient'"'"'s breast is sampled.

23. The method of claim 22, further comprising:

recording said indication of the area of interest in the patient'"'"'s breast as a mark on the tomosynthesis images.

24. The method of claim 23, further comprising:

placing the mark at a corresponding location on at least one of one or more pre-fire images and post-fire image of the patient'"'"'s breast.

25. The method of claim 19, wherein said tomosynthesis scans are performed in step (a) at respective angles, and for each tomosynthesis scan at the corresponding angle, image acquisition is not shadowed or interfered by the biopsy needle.

26. The method of claim 19, further comprising:

allowing the biopsy needle to be positioned at a test position a selected distance from the area of interest;

performing a scan of the patient'"'"'s breast with the biopsy needle positioned at the selected distance from the area of interest, and generating an image based on data acquired from said scan;

indexing the biopsy needle from said test position to a specific position within the area of interest, after receiving confirmation that the area of interest is not obscured by the biopsy needle in the image, and performing at least one additional scan.

27. The method of claim 19, further comprising:

displaying said three-dimensional coordinates of said area of interest;

allowing the biopsy needle to be manually positioned; and

dynamically displaying needle tip coordinates as the biopsy needle is manually positioned.

28. The method of claim 19, further comprising:

determining a volume of said area of interest; and

displaying said volume of said area of interest.

29. The method of claim 19, where the needle positioning in step (d) is via a motorized mechanism.

30. The method of claim 19, wherein the needle positioning in step (d) is performed manually.

31. The method of claim 19, wherein the needle positioning in step (d) is performed by manually operating an hand-operated device.

32. An apparatus for performing breast biopsy, comprising:

a biopsy needle configured to obtain samples of a patient'"'"'s breast;

a collection chamber coupled to the biopsy needle via a sample delivery path; and

a calcification detector coupled to the sample delivery path to determine whether the samples include calcifications and estimate an amount of the calcifications.