IP Library Granted Patent US 12,104,997
Granted Patent B2
US 12,104,997 · App. 18/081,923 · Granted Oct 1, 2024

Multi-axis specimen imaging device with embedded orientation markers

Inventors: Donogh O'Driscoll (Tucson, AZ); Ciaran Purdy (Tucson, AZ); Kimberly A. Fitzpatrick (Tuscon, AZ); Marisa H. Borders (Tucson, AZ)
Assignee: Faxitron Bioptics, LLC
G01N1/36A61B10/0041B01L3/508C12M45/22G01N23/04A61B10/0233B01L2300/0609G01N2223/307G01N2223/6126
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Quick Facts
Patent No.
US 12,104,997
App. No.
18/081,923
Granted
Oct 1, 2024
Kind
B2
Abstract

A specimen holding and positioning apparatus operable to substantially non-movably maintain a specimen (e.g., an excised tissue specimen) in a fixed or stable orientation with respect to the apparatus during imaging operations (e.g., x-ray imaging), transport (e.g., from a surgery room to a pathologist's laboratory), and the like for use in facilitating accurate detection and diagnosis of cancers and/or other abnormalities of the specimen.

Claims (33)

1. A method of imaging a tissue specimen, the method comprising:

providing a tissue specimen retaining apparatus having a body that includes a retention surface, a first orientation marker, a second orientation marker, and at least one indicator;

positioning the tissue specimen on the retention surface and relative to the at least one indicator such that the position of the tissue specimen on the retention surface corresponds to an excision location of the tissue specimen on a patient's breast, wherein the at least one indicator conveys a location of the first orientation marker;

generating a first image of the tissue specimen at an imaging system, wherein the tissue specimen retaining apparatus is orientated such that the retention surface is orthogonal to an imaging axis of the imaging system, wherein the first orientation marker, the second orientation marker, and the at least one indicator appear in the first image, and wherein the first orientation marker is spaced from the tissue specimen in the first image and indicates either a left breast or a right breast excision location and the second orientation marker is fully encompassed within the tissue specimen in the first image;

generating a second image of the tissue specimen at the imaging system, wherein the tissue specimen retaining apparatus is oriented such that the retention surface is not orthogonal to the imaging axis of the imaging system, wherein at least the first orientation marker and the second orientation marker appear in the second image, and wherein the first orientation marker is spaced from the tissue specimen in the second image and indicates either the left breast or the right breast excision location and the second orientation marker is also spaced from the tissue specimen in the second image and indicates an approximate location of a front or a nipple of the breast; and

determining, based on the position of the tissue specimen relative to the first orientation marker and the second orientation marker, the excision location of the tissue specimen on the patient's breast in the first image and the second image such that at least one of the first and second images are oriented relative to a corresponding original mammogram image.

2. The method of claim 1 , wherein the at least one indicator includes a graphic or a design.

3. A method of imaging a tissue specimen, the method comprising:

providing a tissue specimen retaining apparatus having a body that includes a retention surface and at least a first orientation marker and a second orientation marker;

positioning the tissue specimen on the retention surface and relative to at least one of the first and second orientation markers such that the position of the tissue specimen on the retention surface corresponds to an excision location of the tissue specimen on a patient's breast;

generating a first image of the tissue specimen at an imaging system, wherein the tissue specimen retaining apparatus is orientated such that the retention surface is orthogonal to an imaging axis of the imaging system, wherein the first orientation marker and the second orientation marker appear in the first image, and wherein the first orientation marker is spaced from the tissue specimen in the first image and indicates either a left breast or a right breast excision location and the second orientation marker is fully encompassed within the tissue specimen in the first image;

generating a second image of the tissue specimen at the imaging system, wherein the tissue specimen retaining apparatus is oriented such that the retention surface is not orthogonal to the imaging axis of the imaging system, wherein the first orientation marker and the second orientation marker appear in the second image, and wherein the first orientation marker is spaced from the tissue specimen in the second image and indicates either the left breast or the right breast excision location and the second orientation marker is also spaced from the tissue specimen in the second image and indicates an approximate location of a front or a nipple of the breast;

determining, based on the position of the tissue specimen relative to the first and second orientation markers, the excision location of the tissue specimen on the patient's breast in the first image and the second image; and

orienting the first image and the second image relative to at least one corresponding image of the patient's breast containing the tissue specimen prior to excision.

4. The method of claim 3 , further comprising overlaying the first image on the at least one corresponding image of the patient's breast.

5. The method of claim 3 , wherein the body of the tissue specimen retaining apparatus includes a first retention member having the first orientation marker and a second retention member having the second orientation marker, the method further comprising securing the tissue specimen at least partially between the first retention member and the second retention member.

6. The method of claim 3 , wherein the body of the tissue specimen retaining apparatus has at least one indicator readable in the first image, wherein the determination of the excision location of the tissue specimen on the patient's breast in the first image is also based on the at least one indicator.

7. The method of claim 6 , wherein the at least one indicator includes a graphic or a design.

8. A method of imaging a tissue specimen, the method comprising:

providing a tissue specimen retaining apparatus having a body that includes a retention surface, a first orientation marker, and a second orientation marker;

positioning the tissue specimen on the retention surface and relative to the first and second orientation markers;

generating a first image of the tissue specimen at an imaging system, wherein the tissue specimen retaining apparatus is orientated such that the retention surface is orthogonal to an imaging axis of the imaging system, wherein at least the first orientation marker and the second orientation marker appear in the first image, and wherein the first orientation marker is spaced from the tissue specimen in the first image and indicates either a left breast or a right breast excision location and the second orientation marker is fully encompassed within the tissue specimen in the first image;

generating a second image of the tissue specimen at the imaging system, wherein the tissue specimen retaining apparatus is orientated such that the retention surface is not orthogonal to the imaging axis of the imaging system, wherein the first orientation marker and the second orientation marker appear in the second image, and wherein the first orientation marker is spaced from the tissue specimen in the second image and indicates either the left breast or the right breast excision location and the second orientation marker is also spaced from the tissue specimen in the second image and indicates an approximate location of a front or a nipple of the breast;

generating a third image of the tissue specimen at the imaging system, wherein the tissue specimen retaining apparatus is orientated at a different orientation than the first image and the second image, wherein the first orientation marker and the second orientation marker appear in the third image, and wherein the second orientation marker is spaced from the tissue specimen in the third image and indicates the approximate location of the front or the nipple of the breast;

determining an excision location of the tissue specimen on a patient's breast based on the relative position of the first and second orientation markers relative to the tissue specimen in the first, second, and third images; and

orienting at least one of the first image, the second image, and the third image relative to at least one corresponding image of the patient's breast containing the tissue specimen prior to excision.

9. The method of claim 8 , further comprising overlaying at least one of the first image, the second image, and the third image on the at least one corresponding image of the patient's breast.

10. The method of claim 8 , wherein the at least one corresponding image is a mammogram image.

11. The method of claim 8 , wherein the body of the tissue specimen retaining apparatus has at least one indicator, the at least one indicator useable with the first orientation marker to determine the left breast or the right breast excision location.

12. The method of claim 11 , wherein the at least one indicator includes a graphic or a design.

13. The method of claim 8 , wherein the body of the tissue specimen retaining apparatus includes a first retention member having the first orientation marker and a second retention member having the second orientation marker, the method further comprising securing the tissue specimen at least partially between the first retention member and the second retention member.

14. The method of claim 13 , wherein the first retention member is at least partially elastically deformable and the second retention member is at least partially elastically deformable for surrounding the tissue specimen.

15. The method of claim 5 , wherein the first retention member is at least partially elastically deformable and the second retention member is at least partially elastically deformable for surrounding the tissue specimen.

Assignments (7)
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 065286/0407 Recorded Apr 24, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC.; GEN-PROBE INCORPORATED; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.; GEN-PROBE PRODESSE, INC.
Reel/Frame 075457/0767 →
SECURITY INTEREST Recorded Apr 8, 2026
From: BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; CYTYC CORPORATION; SUROS SURGICAL SYSTEMS, INC.; GYNESONICS, INC.; BOLDER SURGICAL, LLC; FAXITRON BIOPTICS, LLC; HEALTH BEACONS, INC.; HOLOGIC, INC.
To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT
Reel/Frame 075462/0440 →
SECURITY INTEREST Recorded Oct 19, 2023
From: HOLOGIC, INC.; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 065286/0407 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2022
From: PURDY, CIARAN; O'DRISCOLL, DONOGH
To: FAXITRON BIOPTICS, LLC
Reel/Frame 062102/0569 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2022
From: THE ARIZONA BOARD OF REGENTS ON BEHALF OF THE UNIVERSITY OF ARIZONA
To: FAXITRON BIOPTICS, LLC
Reel/Frame 062102/0714 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2022
From: PURDY, CIARAN; O'DRISCOLL, DONOGH
To: FAXITRON BIOPTICS, LLC
Reel/Frame 062102/0616 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2022
From: FITZPATRICK, KIMBERLY A.; BORDERS, MARISA H.
To: THE ARIZONA BOARD OF REGENTS ON BEHALF OF THE UNIVERSITY OF ARIZONA
Reel/Frame 062102/0691 →
Continuity (6)
Continuation 16932008 · Jul 17, 2020
Continuation 15904567 · Feb 26, 2018
Continuation PCTUS2016050169 · Sep 2, 2016
Provisional Application 62215064 · Sep 7, 2015
Provisional Application 62214520 · Sep 4, 2015
Related Publication 20230204473A1 · Jun 29, 2023