Transporter systems, assemblies and associated methods for transporting tissue samples

Patent metadata

Field	Value
Publication number	US-11071978-B2
Application number	US-201715659581-A
Country	US
Kind code	B2
Filing date	Jul 25, 2017
Priority date	Jan 26, 2015
Publication date	Jul 27, 2021
Grant date	Jul 27, 2021

Abstract

A tissue sample that has been removed from a subject can be properly fixed for evaluation using the disclosed transporter assembly for carrying a tissue sample and method for fixing an unfixed tissue sample. In one embodiment, the disclosed assembly includes a transport container, a fixative in the transport container, and a cooling device that reduces and/or maintains the temperature of the fixative to perform a pre-soaking process at a temperature of less than about 7° C. The pre-soaking process can, for example, be performed during sample transport or during extended periods of storage, such as over a weekend.

First claim

The invention claimed is:

1. A tissue sample transport and storage assembly comprising:
(a) a sample container assembly comprising:
(a1) a wall defining a first cavity for holding a volume of a fixative solution;
(a2) a container lid comprising a first side and a second side, wherein the container lid is configured to create a fixative impervious barrier enclosing the first cavity, wherein the second side faces the first cavity and wherein the first side faces away from the cavity;
(a3) a cassette holder movable between a first position on the first side of the container lid and a second position on the second side of the container lid;
(a4) a histology cassette removably attached to the cassette holder and configured such that when the cassette holder is in the second position, the histology cassette is immersed in the volume of the fixative solution held within the first cavity; and
(a5) a cassette cover removably and directly coupled to the first side of the container lid and configured to cover the histology cassette when the cassette holder is in the first position:

(b) a temperature-responsive element disposed on an outer surface of the wall defining the first cavity, where the temperature-responsive element is in thermal communication with the volume of the fixative solution: and
(c) a case assembly comprising a second cavity, wherein the case assembly comprises an insulator material and/or a cooling element, wherein the second cavity is sized to accept the sample container assembly and the temperature-responsive element, and wherein the insulator material and/or a cooling element is configured to maintain the volume of the fixative solution at a temperature in the range of 0° C. to 7° C. for at least 2 hours when the tissue sample transport and storage assembly is assembled.

2. The tissue sample transport and storage assembly of claim 1 , wherein the cassette holder is configured to be screwed into at least one of the first and second sides of the container lid.

3. The tissue sample transport and storage assembly of claim 1 , wherein the histology cassette is clipped to the cassette holder.

4. The tissue sample transport and storage assembly of claim 1 , wherein the cassette holder comprises:
a first end operable to be coupled to at least one of the first and second sides of the container lid; and
a second end operable to be coupled to the histology cassette.

5. The tissue sample transport and storage assembly of claim 1 , wherein the cassette cover establishes a sterile seal between the container lid and the histology cassette when the cassette holder is in the first position.

6. The tissue sample transport and storage assembly of claim 1 , wherein the sample container assembly further comprises a cassette septum, wherein the cassette septum is removable with said container lid, said cassette holder, and said histology cassette.

7. The tissue sample transport and storage assembly of claim 6 , wherein said cassette septum comprises a breakable membrane.

8. The tissue sample transport and storage assembly of claim 7 , wherein said container lid further comprises an arm operable to break said breakable membrane upon insertion of the histology cassette into said the first cavity of said sample container assembly.

9. The tissue sample transport and storage assembly of claim 1 , wherein said container lid further comprises a portion comprising an internal screw thread portion configured to couple with an external screw thread portion of said sample container, operable to isolate the sample, air and said fixative from a surrounding environment.

10. The tissue sample transport and storage assembly of claim 1 , wherein the insulator material defining the second cavity comprises a cooling element.

11. The tissue sample transport and storage assembly of claim 10 , wherein the cooling element comprises at least one element selected from the group consisting of:
a first substance and a second substance that mix to produce an endothermic reaction in response to a fixation-inhibiting cooling device changing from a non-cooling mode to a cooling mode;
a desiccant and a substance that evaporates to cool the fixative; and
a refrigeration unit or a thermoelectric cooler unit.

12. The tissue sample transport and storage assembly of claim 10 , wherein the cooling element comprises a cooling material having a freezing point in the range of 0° C. to 7° C.

13. The tissue sample transport and storage assembly of claim 12 , wherein the volume of the cooling material is selected such that the time for the volume of coolant to transition from completely frozen to completely melted is at least two hours when stored at 20° C. without pressurization.

14. The tissue sample transport and storage assembly of claim 1 , wherein said temperature responsive element comprises an absorbent material and a dye, wherein the dye can diffuse through the absorbent material when at a first temperature range and to not diffuse through the dye when at a second temperature range, wherein the extent of diffusion of the dye through the absorbent material correlates with the amount of time that the fixative solution has been at a temperature in the first temperature range.

15. The tissue sample transport and storage assembly of claim 14 , wherein the first temperature range is from 0° C. to 7° C., and the second temperature range is a temperature above 7° C.

16. The tissue sample transport and storage assembly of claim 14 , wherein the dye is disposed in a matrix having a melting point at a temperature above 7° C., wherein the first temperature range is a temperature at or above the melting point, wherein the second temperature range is a temperature below the melting point.

17. The tissue sample transport and storage assembly of claim 1 , wherein said temperature responsive element comprises:
a first absorbent material and a first dye, wherein the first dye is engineered to diffuse through the absorbent material when at temperature range is from 0° C. to 7° C. and to not diffuse through the absorbent material when at a temperature above 7° C., and wherein the extent of diffusion of the first dye through the first absorbent material correlates with the amount of time that the formalin-based fixative solution has been at a temperature in the temperature range from 0° C. to 7° C.;
a second absorbent material and a second dye, wherein the second dye is disposed in a matrix having a melting point at a temperature above 7° C., wherein the second dye begins diffusing through the second absorbent material when the matrix begins melting, and wherein the extent of diffusion of the second dye through the second absorbent material correlates with the amount of time that the formalin-based fixative solution has been at a temperature above the melting point.

18. The tissue sample transport and storage assembly of claim 17 , wherein the first and/or second absorbent material is attached to the walls or the seal of the sample container assembly without being placed within the cavity defined by the walls.

19. The tissue sample transport and storage assembly of claim 1 , further comprising a data logger.

20. The tissue sample transport and storage assembly of claim 19 , wherein the temperature responsive element comprises a temperature sensor configured to communicate the temperature of the formalin-based fixative solution to the data logger.

21. The tissue sample transport and storage assembly of claim 20 , wherein the temperature sensor is an infr

Assignees

• Ventana Med Syst Inc

Inventors

• Crum Nathan
• Keller Timothy
• Laing Alastair
• Otter Michael
• Petre Vinnie
• Pigman Elizabeth
• Shingler Taylor
• Stanislaw Stacey
• Stevens Benjamin

Classifications

• B01L7/04

  Heat insulating devices, e.g. jackets for flasks · CPC title

• G01N2001/315

  Basket-type carriers for tissues · CPC title

• B01L2300/1855

  using phase changes in a medium · CPC title

• B01L2300/024

  Storing results with means integrated into the container · CPC title

• G01N1/31

  Apparatus therefor · CPC title