Cryogenic storage container, storage device, and methods of using the same

• US 9,297,499 B2
• Filed: 12/05/2013
• Issued: 03/29/2016
• Est. Priority Date: 12/06/2012
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated), Sabin Corporation (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Jimenez-Rios, Jorge L., Woodard, Bryan D., Nichols, Shawn, Hoult, Barry B., Philhower, Scott K.
• Primary Examiner(s): Jones, Melvin
• Application Number:
  US14/097,357
• Publication Number:
  US 20140157798A1
• Time in Patent Office: 845 Days
• Field of Search: 62/62, 623/71, 624/572, 624/575, 624/65, 220/560.12, 220/592.2
• US Class Current: 1/1
• CPC Class Codes: A01N 1/0257 Stationary or portable vessels generating cryogenic temperatures
• CPC Class Codes: A01N 1/0268 Carriers for immersion in cryogenic fluid, both for slow-freezing and vitrification, e.g. open or closed "straws" for embryos, oocytes or semen
• CPC Class Codes: B01L 2200/147 Employing temperature sensors
• CPC Class Codes: B01L 2300/1883 using thermal insulation
• CPC Class Codes: B01L 7/50 Cryostats
• CPC Class Codes: B01L 9/06 Test-tube stands; Test-tube holders
• CPC Class Codes: F17C 13/001 Thermal insulation specially adapted for cryogenic vessels vessels not under pressure with insulation F17C3/02; thermal insulation in general F16L59/00
• CPC Class Codes: F25D 3/10 using liquefied gases, e.g. liquid air for cooling semiconductor devices H01L23/445

Abstract

A device for the cryopreservation and/or vitrification of a biological sample in a freezing medium is described. The device preferably comprises a bath for receiving a vessel containing a biological sample in liquid-phase nitrogen. In one example, the bath includes a first member extending generally vertically from a bottom wall portion which divides the interior chamber of the bath into a first sub-chamber adapted for receiving a volume of cryogenic freezing medium and a second or overflow sub-chamber adapted to receive freezing medium from the first sub-chamber. A second member extends generally horizontally between the sidewall portions of the bath and includes at least one opening for receiving a biological sample-containing vessel(s). A kit including a cryogenic storage device and a vessel is also described.

Claims

1. A cryogenic storage device comprising:

a container comprising a bottom wall portion and at least two side wall portions, the bottom and side wall portions forming an interior chamber and wherein the container comprises an inner surface and an outer surface,

a thermal insulating material covering at least a portion of one or both of the inner and outer surfaces of the container;

a first member having a surface extending generally vertically from the bottom wall portion of the container and dividing the interior chamber into a first sub-chamber adapted for receiving a volume of cryogenic freezing medium and a second sub-chamber;

a second member having a surface extending generally horizontally between the sidewall portions of the container into the first sub-chamber, wherein the generally horizontal surface comprises at least one opening formed therein configured to receive one or more biological sample-containing vessels.

2. The device of claim 1 wherein the container comprises a generally bowl-shaped reservoir or bath.

3. The device of claim 1 wherein the container comprises plastic or metal.

4. The device of claim 1 wherein the insulating material comprises at least one of polystyrene foam and a vacuum insulation layer.

5. The device of claim 1 wherein the cryogenic freezing medium comprises liquid nitrogen.

6. The device of claim 1 wherein the generally vertical surface of the first member comprises at least one of a wall, a plate, a sheet, a membrane and a barrier.

7. The device of claim 1 wherein the generally horizontal surface of the second member comprises at least one of a plate, a rack, a cane, a support, a holder, an organizer and a shelf.

8. The device of claim 1 wherein at least one of the first and second members is integrally formed with the container.

9. The device of claim 1 wherein at least one of the first and second members may be secured to the container by at least one of interference fit, friction fit, welding, adhesive, bonding and a fastener.

10. The device of claim 1 wherein the at least two sidewall portions comprise at least one groove formed therein and wherein at least a portion of the second member is configured to be received within the at least one groove.

11. The device of claim 1 wherein the biological sample-containing vessel comprises a vial adapted for the cryopreservation of a biological sample therein.

12. The device of claim 1 wherein the second sub-chamber comprises an overflow chamber configured to receive a volume of cryogenic freezing medium from the first sub-chamber.

13. The device of claim 1 wherein the first member further comprises a top surface configured to allow cryogenic freezing medium to flow from the first sub-chamber to the second sub-chamber and wherein the top surface is located at a selected vertical position in order to maintain a volume of liquid nitrogen in the first sub-chamber at a desired level.

14. The device of claim 1 further comprising a cutting element.

15. A cryogenic storage kit comprising:

a. a cryogenic storage device comprising;

a container comprising a bottom wall portion and at least two side wall portions, the bottom and side wall portions forming an interior chamber and wherein the container comprises an inner surface and an outer surface,

a thermal insulating material covering at least a portion of one or both of the inner and outer surfaces of the container;

a first member having a surface extending generally vertically from the bottom wall portion of the container and dividing the interior chamber into a first sub-chamber adapted for receiving a volume of cryogenic freezing medium and a second sub-chamber;

a second member having a surface extending generally horizontally between the sidewall portions of the container into the first sub-chamber, wherein the generally horizontal surface comprises at least one opening formed therein configured to receive one or more biological sample-containing vessels;

b. a vessel adapted to receive and retain a biological sample during cryopreservation.

16. The kit of claim 15 wherein the container further comprises a generally bowl-shaped reservoir or bath.

17. The kit of claim 15 wherein the insulating material comprises at least one of polystyrene foam and a vacuum insulation layer.

18. The kit of claim 15 wherein the generally vertical surface of the first member comprises at least one of a wall, a plate, a sheet, a membrane and a barrier.

19. The kit of claim 15 wherein the generally horizontal surface of the second member comprises at least one of a plate, a rack, a cane, a support, a holder, an organizer and a shelf.

20. The kit of claim 15 wherein at least one of the first and second members may be integrally formed with the container.

21. The kit of claim 15 wherein the vessel comprises at least one of a container, a tube, a vial, a straw and an ampule.

22. The kit of claim 15 wherein the second sub-chamber comprises an overflow chamber configured to receive a volume of cryogenic freezing medium from the first sub-chamber.

23. The kit of claim 15 wherein the vessel comprises:

a body comprising a proximal open end and a sealed distal end and a variable diameter lumen extending there between,

the lumen having an external surface and an internal surface, the internal surface tapering generally radially inwardly from the proximal open end to the distal end and forming a sealing portion and a sample receiving portion,

a closure configured for removable attachment to the body wherein the closure comprises a capping member adapted for engagement with the proximal open end and a deformable member having a tapered external surface configured for sealing engagement with the lumen internal surface, and

at least two projections extending radially outwardly from the external surface of the lumen, the projections comprising a radially outward most surface extending between the proximal open end and the sealed distal end of the body.

24. The kit of claim 23 wherein the vessel further comprises at least one ear extending outwardly from the body adjacent the proximal open end and wherein the closure further comprises at least one slot that is configured to receive the at least one ear therein, such that when the closure is rotated the at least one ear is slideably engaged within the at least one slot and wherein the external surface of the deformable member comprises a male taper and the internal surface of the lumen comprises a female taper and wherein the male taper and female taper have corresponding taper angles such that a fluid tight seal is established between the respective tapered surfaces.

25. A cryogenic storage method comprising:

a. introducing a biological sample into the lumen of a storage vessel;

b. placing the storage vessel in a cryogenic storage device, the storage device comprising;

i. a container comprising a bottom wall portion and at least two side wall portions, the bottom and side wall portions forming an interior chamber and wherein the container comprises an inner surface and an outer surface,

ii. a thermal insulating material covering at least a portion of one or both of the inner and outer surfaces of the container,

iii. a first member having a surface extending generally vertically from the bottom wall portion of the container and dividing the interior chamber into a first sub-chamber containing a volume of cryogenic freezing medium and a second sub-chamber;

iv. a second member having a surface extending generally horizontally between the sidewall portions of the container into the first sub-chamber, wherein the generally horizontal surface comprises at least one opening formed therein configured to receive one or more biological sample-containing storage vessels;

c. exposing at least a portion of the sample-containing vessel to a cryogenic freezing medium in the storage device.

26. The method of claim 25 wherein the lumen of the vessel is pre-cooled in the storage device to a temperature suitable for the vitrification of a biological sample in the vessel lumen prior to the step of introducing the biological sample into the lumen.