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Title:
BIOPSY TISSUE SAMPLE CASSETTE AND RELATED SYSTEMS AND METHODS
Document Type and Number:
WIPO Patent Application WO/2019/046466
Kind Code:
A4
Abstract:
Tissue sample cassettes for receiving tissue samples include an upper tray including compartments separated by dividers, a lower tray coupled to the upper tray and having a central recess, and an absorbent material located in the recess of the lower tray. Related systems and methods for automated gross processing of tissue samples are also disclosed.

Inventors:
EVANS MARK (US)
IVIE MICHAEL (US)
Application Number:
PCT/US2018/048608
Publication Date:
May 23, 2019
Filing Date:
August 29, 2018
Export Citation:
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Assignee:
LEAVITT MEDICAL INC (US)
International Classes:
A61B10/02; G01N1/31; G01N1/36
Attorney, Agent or Firm:
PULLEY, Stephen (US)
Download PDF:
Claims:
AMENDED CLAIMS

received by the International Bureau on 24 April 2019 (24.04.2019)

WHAT IS CLAIMED IS:

1. A tissue sample cassette comprising:

an upper tray comprising multiple compartments separated by dividers in a top wall of the upper tray;

a lower tray coupled to the upper tray, the lower tray comprising a central recess defined by

sidewalls located on a base of the lower tray; and

an absorbent material located in the central recess of the lower tray, the dividers of the upper tray being located over an upper surface of the absorbent material, wherein the compartments are sized and configured to retain respective biopsy tissue samples therein and over the upper surface of the absorbent material.

2. The tissue sample cassette of claim 1, further comprising:

a cover releasably secured to at least one of the upper tray or the lower tray, the cover comprising indentations in an upper surface thereof, the indentations being sized and configured to respectively at least partially extend into the compartments of the upper tray.

3. The tissue sample cassette of claim 2, wherein at least a portion of a lower surface of the cover proximate the upper tray comprises a hydrophobic material, and wherein at least a portion of the upper surface of the absorbent material comprises a hydrophilic material.

4. The tissue sample cassette of claim 2, wherein each of the cover and the lower tray comprises at least one tab to facilitate removal of the cover from the lower tray.

5. The tissue sample cassette of any one of claims 1 through 4, wherein the dividers of the upper tray include inner sidewalls comprising depth markers, each of the compartments comprising an elongated opening in the top wall of the upper tray and a recess in a front wall configured to facilitate placement of the biopsy tissue samples on the upper surface of the absorbent material through the elongated opening.

6. The tissue sample cassette of claim 5, wherein the inner sidewalls of the dividers of the upper tray comprises an upper vertical portion, a lower vertical portion, and an inclined portion between the upper vertical portion and the lower vertical portion.

7. The tissue sample cassette of any one of claims 1 through 4, wherein the upper tray further comprises:

a front wall, a back wall opposite the front wall, a first sidewall, and a second sidewall opposite the first sidewall, wherein the top wall of the upper tray extends between the front wall, the back wall, the first sidewall, and the second sidewall.

8. The tissue sample cassette of claim 7, wherein the top wall of the upper tray further comprises alphanumeric indicators corresponding to the compartments, each of the alphanumeric indicators located on the top wall of the upper tray between the back wall of the upper tray and a distal end of a respective compartment.

9. The tissue sample cassette of any one of claims 1 through 4, wherein the absorbent material comprises an upper surface with at least one cutout sized and shaped for receiving a biopsy tissue sample therein.

10. The tissue sample cassette of any one of claims 1 through 4, further comprising a tracking element, wherein:

the tracking element is located on a lower surface of a base portion of the lower tray; and the tracking element is selected from the group consisting of a radio-frequency identification

(RFID) tag, a barcode label, a written label, and a serial number label.

11. The tissue sample cassette of any one of claims 1 through 4, wherein the absorbent material comprises a pre-wetted sponge, a material forming the tissue sample cassette being resistant to degradation when exposed to at least one of formalin, an RNA preservative, saline solution, a chemical fixative, and/or water.

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12. The tissue sample cassette of any one of claims 1 through 4, wherein the compartments of the upper tray each comprise an elongated compartment sized to receive a needle-core biopsy tissue sample.

IB. A system for automated gross processing of tissue samples in a tissue sample cassette, comprising:

the tissue sample cassette any one of claims 1 through 4, wherein the tissue sample cassette further comprises a tracking element;

at least one imaging device configured to obtain images of biopsy tissue samples positioned within respective compartments of the tissue sample cassette;

a tracking element reader associated with the at least one imaging device and configured to read information from the tracking element of the tissue sample cassette; and

a processor associated with the at least one imaging device and the tracking element reader, the processor in communication with memory configured to store the images of the biopsy tissue samples, wherein the processor is programmed to recognize the tissue samples and to determine and provide gross measurements for the biopsy tissue samples based on the images of the biopsy tissue samples obtained with the at least one imaging device.

14. The system of claim 13, wherein the processor is configured to accept information associated with the tracking element of the tissue sample cassette, the tracking element being read by the tracking element reader.

15. The system of claim 13, wherein the processor is configured to process information associated with records stored in a data storage unit.

16. The system of claim 13, wherein the gross measurements provided by the processor include at least one of height, length, or area of the biopsy tissue samples.

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17. A method of providing gross measurements of biopsy tissue samples in a tissue sample cassette, the method comprising:

supporting, with an upper surface of an absorbent material, multiple biopsy tissue samples in respective compartments of a multi-compartment tissue sample cassette;

acquiring at least one image of the biopsy tissue samples in the multi-compartment tissue sample cassette utilizing an imaging device; and

determining gross measurements of the biopsy tissue samples using a processor programmed to distinguish the biopsy tissue samples relative to the multi-compartment tissue sample cassette from the at least one image and to provide the gross measurements based on the at least one image.

18. The method of claim 17, further comprising:

linking the acquired at least one image and the gross measurements with records using a tracking element reader configured to recognize a tracking element associated with the multi compartment tissue sample cassette.

19. The method of claim 17, further comprising:

transporting the biopsy tissue samples with the tissue sample cassette to a pathology laboratory without the biopsy tissue samples being suspended in a fluid.

20. The method of claim 17, wherein acquiring at least one image of the biopsy tissue samples utilizing the imaging device comprises acquiring a plurality of images of the biopsy tissue samples with at least one camera.

21. The method of claim 17, wherein determining gross measurements of the biopsy tissue samples utilizing a processor comprises using the processor to recognize biopsy tissue samples based on the acquired images and based at least in part on information stored in a data storage unit.

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