WO2002028733A1

WO2002028733A1 - Segmented vial assembly and related storage and retrieval method

Info

Publication number: WO2002028733A1
Application number: PCT/US2001/030697
Authority: WO
Inventors: Daniel D. Richard; Michael T. Starr
Original assignee: Cryo-Cell International, Inc.
Priority date: 2000-10-02
Filing date: 2001-10-01
Publication date: 2002-04-11
Also published as: AU2001296452A1

Abstract

A segmented cryogenic container assembly (20) includes a vial or ampule (22) having a storage chamber (24) for storing biological specimens (26) at low temperatures. The vial or ampule contains at least one partition member (28) subdividing the chamber into a plurality of intercommunicating storage compartments. It is contemplated that the storage assembly includes a cap (40) attachable to the vial for closing the storage chamber. In some embodiments of the invention, the partition member is connected to the cap. The vial assembly and an associated methodology permit expedient removal of a plug of frozen material from a specimen stored within a single container. Upon removal of the test plug or sample, the remaining material is returned to the freezer while testing of the removed sample is undertaken.

Description

SEGMENTED VIAL ASSEMBLY AND RELATED STORAGE AND RETRIEVAL METHOD

BACKGROUND OF THE INVENTION

This invention relates to a vial assembly, particularly, but not exclusively, utilizable in low-temperature storage of biological specimens. This invention also relates to an associated method for storing and retrieving specimens from storage such as low temperature storage.

Prior to the utilization of cryogenically stored material, it is occasionally necessary to thaw a sample from the total lot for the purpose of testing. This sampling is typically accomplished by separating the material into multiple containers before freezing, thereby permitting the removal of a single test container while the balance of the material is maintained within the cryogenic environment. There are a number of disadvantages associated with this procedure. Besides inefficient use of space, which is normally at a premium, there is no guarantee that the test container has been subjected to the identical conditions as the balance of the lot.

SUMMARY OF THE INVENTION

The present invention is directed to an improved vial assembly, particularly a vial assembly which solves the problem of maintaining vial content integrity while enabling removal of a test sample from a stored specimen. The present invention also addresses the associated problem of ensuring that the identities of a test sample and a remaining portion of a stored specimen are the same. A vial assembly in accordance with the present invention facilitates the testing of a cryogenically stored specimen.

The present invention also provides a method for storing specimens, particularly, but not exclusively, biological specimens, and selectively retrieving portions of the stored specimens. The method is of advantage in the storage of biological specimens at reduced temperatures.

Accordingly, the present invention is directed to a vial assembly and an associated methodology which permit expedient removal of a plug of frozen material from a specimen stored within a single container. Upon removal of the test plug or sample, the remaining material is returned to the freezer while testing of the removed sample is undertaken.

A container assembly in accordance with the present invention comprises a vial or ampule having a storage chamber for storing biological specimens at low temperatures. The vial or ampule contains at least one partition member subdividing the chamber to form a segmented chamber having a plurality of intercommunicating storage compartments.

The intercommunication between the storage compartments is for the purpose of enabling or inducing a condition of equilibrium or homogeneity in the distribution of a single stored specimen among the different storage compartments. The effect of storage operations is assumed to be the same for all portions of the stored specimen in the different compartments. Thus, when a sample portion of the entire stored specimen is extracted from the container assembly for testing, that removed sample is likely to exhibit the same characteristics as the remainder of the stored specimen. It is contemplated that the storage assembly includes a cap attachable to the vial for closing the storage chamber. In some embodiments of the invention, the partition member is connected to the cap. The partition member may be attached to the cap prior to the deposition of a specimen into the storage chamber of the vial. The attachment may be effectuated by any suitable means. Preferable means include a threaded connection and a force lock fit, for instance, where the partition member is provided with one or more projections which are forcibly inserted into respective receptacles on the cap. In a particular embodiment of the present invention, the partition member includes an elongate hollow element provided with a first aperture at an end spaced from the cap and a second aperture disposed more proximally to the cap. The apertures define a fluid flow path which allows a portion of the stored specimen to enter a compartment defined by the hollow element and simultaneously vents air from that compartment. Preferably, the hollow element is tapered, with a smaller end extending into a stored specimen to facilitate removal of the hollow element (and a test sample of the specimen contained therein) from the specimen after the specimen has been hardened by freezing. This hollow element may be attached to the cap of the vial. In another particular embodiment of the present invention, the partition member includes an elongate hollow element provided with a slot extending longitudinally along the hollow element. The slot performs the same flow facilitation function as the two apertures described above. This slotted hollow element may also be tapered and attached to the cap of the vial. In a further particular embodiment of the present invention, the partition member includes a flat elongate panel projecting from the cap. This panel projects parallel to an axis of the cap and may be coaxial with that axis. More specifically, the panel may be one of any plurality of panels connected to one another at a hub extending along an axis of the cap. The various panels radiate from the hub in any desired pattern. For example, the panels may be three in number and angularly equispaced about the hub. Alternatively, the panels may be four in number and disposed at varying angles about the hub of the partition member.

In yet another particular embodiment of the present invention, the partition member is one of a plurality of partition members each in the form of a separate container inserted in the storage chamber to define a respective one of the compartments. These containers are preferably provided at their lower ends and upper ends with apertures for facilitating the transfer or diffusion of specimen material between the different compartments defined by the containers. It is contemplated that at least upper portions of the respective container inserts fit together like slices of a pie. The lower ends of the container inserts may be tapered to facilitate eventual removal from the outer vial.

A method for storing biological specimens at low temperatures and enabling a selective retrieval of the specimens utilizes a vial defining a storage chamber having a plurality of intercommunicating compartments and containing a single fluidic specimen disposed in the chamber and distributed among the compartments. The vial and portions of the specimen disposed in respective ones of the compartments are subjected to low temperatures which results in a freezing of the portions of the fluidic specimen stored in the respective compartments. Subsequent to the freezing of the specimen portions in the respective compartments, one of the portions of the specimen is removed from a respective one of the compartments while another specimen portion is maintained in the storage chamber.

Pursuant to another feature of the present invention, the providing of the vial includes depositing the fluidic specimen in the chamber, subdividing the chamber into the compartments, and allowing the deposited specimen to flow into the different compartments to form the portions of the specimen in the compartments.

The subdividing of the chamber into the compartments may occur prior to or after the deposition of the specimen in the chamber of the vial. In either case, the subdividing of the storage chamber preferably includes inserting at least one divider or partition member into the chamber. Where the divider or partition member is connected to a cap of the vial, the method further comprises attaching the cap to the vial after inserting the divider or partition member into the chamber.

Where the divider or partition member is one of a plurality of divider or partition members each in the form of a separate container defining a respective one of the compartments, the subdividing of the chamber includes inserting all of the containers into the chamber.

Where the divider or partition member is formed with a first aperture and a second aperture, the specimen is deposited into the vial chamber in such an amount that the first aperture is disposed above an upper level of the specimen in the chamber and the second aperture is disposed below the upper level of the specimen in the chamber, whereby the deposited specimen is allowed to flow into the compartments to form the portions of the specimen in the compartments.

As discussed above, it is contemplated that the specimen is a single homogeneous sample so that each of the specimen portions in the different compartments of the vial is effectively identical to all the other specimen portions. An extracted sample portion of the entire stored specimen is thus likely to exhibit the same characteristics as the remainder of the stored specimen.

An improved, segmented, vial assembly in accordance with the present invention facilitates removal of a test sample from a stored specimen. This facilitation is particularly useful when the specimen is stored at a low (cryogenic) temperature.

A vial assembly in accordance with the present invention, including segmented vial asseblies, enhances the chances of identity between a test sample extracted from a stored specimen and a remaining portion of the stored specimen.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a longitudinal cross-sectional view of a segmented vial assembly in accordance with the present invention, showing a tapered chamber-partitioning receptacle or insert disposed inside a vial.

Fig. 2 is a side elevational view of the receptacle or insert of Fig. 1. Fig. 3 is a top view of the receptacle or insert of Figs. 1 and 2. Fig. 4 is a side elevational view of a modified chamber-partitioning receptacle or insert disposable inside the vial of Fig. 1. Fig. 5 is a top view of the receptacle or insert of Fig. 4.

Fig. 6 a longitudinal cross-sectional view of another segmented vial assembly in accordance with the present invention, showing a chamber-partitioning insert disposed inside a vial.

Fig. 7 is a side elevational view of the partition or insert of Fig. 6. Fig. 8 is a top view of the partition or insert of Fig. 7.

Fig. 9 is a longitudinal cross-sectional view of yet another segmented vial assembly in accordance with the present invention, showing chamber-partitioning container or receptacle inserts disposed inside a vial.

Fig. '10 is a side elevational view of the chamber-partitioning container inserts of Fig. 9, showing the inserts in a clustered or close configuration.

Fig. 11 is a top view of chamber-partitioning container inserts of Figs. 9 and 10.

Fig. 12 is a side elevational view, similar to Fig. 10, showing the chamber- partitioning container inserts of that drawing figure in an exploded configuration. Fig. 13 is a top view of chamber-partitioning container inserts of Fig. 12. Fig. 14 is a side elevational view of a modified chamber partitioning container insert in accordance with the present invention, utilizable in the vial assembly of Fig. 9 in substitution for the container inserts of Figs. 10-13. Fig. 15 is a top view of chamber-partitioning container insert of Fig. 14.

Fig. 16 is a partial side elevational view of a detail of the chamber-partitioning container insert of Fig. 14.

DESCRIPTION OF THE PREFERRED EMBODIMENTS As illustrated in Figs. 1-3, a segmented container assembly 20 for use in the cryogenic storage of biological specimens includes a vial or ampule 22 having a storage chamber 24 for a single fluidic or flowable biological specimen 26 at cryogenically low temperatures. Vial or ampule 22 contains a partition member 28 in the form of a tapered hollow receptacle which subdivides chamber 24 into an external compartment 30 and an internal compartment 32 inside the tapered receptacle 28. Compartments 30 and 32 communicate with one another via a specimen-admitting aperture 34 at a bottom end of receptacle 28 and via a vent or aperture 36 proximate to an upper end of receptacle 28.

As shown in Fig. 2, partition member or receptacle 28 is provided at an upper end with a plurality of longitudinally extending ridges or beads 38 which are insertable in a force-lock or friction fit in a cap 40 attached to an upper end of vial 22 for sealing chamber 24. It is contemplated that partition member or receptacle 28 is attached to cap 40 prior to the deposition of specimen 26 in storage chamber 24 of vial 22. The intercommunication between compartments 30 and 32 enabled by apertures 34 and 36 facilitates the diffusion of the flowable material of specimen 26 between compartments 30 and 32, and particularly from compartment 30 into compartment 32 upon an insertion of the tapered end (not separately designated) of partition member or receptacle 28 into the material of specimen 26 at the onset of a storage operation. The intercommunication between compartments 30 and 32 enabled by apertures 34 and 36 also facilitates a uniform action of physical conditions on the specimen material in compartments 30 and 32 during a cooling of container assembly 20 and specimen 26. Thus, an equilibrium or homogeneity in the distribution of a single stored specimen 26 is produced among the different storage compartments 30 and 32. The effect of storage operations is equalized for the portions of the stored specimen 26 in the different compartments 30 and 32. Thus, when the sample specimen portion stored frozen in compartment 32 is subsequently extracted from container assembly 20 for testing, that removed sample is likely to exhibit the same characteristics as the remaining specimen portion stored frozen in compartment 30.

The tapering of partition member or receptacle 28 has the function of facilitating the extraction of the receptacle from a frozen specimen 26. Apertures 34 and 36 function as flow-facilitating features, which define a fluid flow path permitting a portion of the stored specimen 26 to enter compartment 32 and simultaneously venting air from that compartment.

As shown in Figs. 4 and 5, a modified partition member or receptacle 42 takes the form of an elongate hollow element provided with a slot 44 extending longitudinally along the hollow element from a tapered end 46 thereof. Slot 44 performs the same flow facilitation function as apertures 34 and 36. Partition member or receptacle 42 is provided with an alternative attachment element in the form of an external screw thread 48 for attaching the partition member or receptacle to cap 40.

As illustrated in Figs. 6-8, a vial or ampule 50 of a segmented cryogenic container assembly 51 is provided with a partition member or compartmentalizing insert 52 including four flat elongate panels 54-57 connected to one another along a hub 58 defined as a linear intersection of the panels. Partition member or insert 52 further includes a coupling element 60 at an upper end for connecting the partition member or insert to an end cap 62 of vial 50. Coupling element 60 is provided with a plurality of ridges or beads 64 which are inserted into end cap 62 in a force-lock or friction fit.

Hub 58 of partition member or compartmentalizing insert 52 lies along an axis 66 of cap 62 and vial 50. Panels 54-57 are formed in a cross-shaped configuration and extend parallel to axis 66. However, it is to be noted that partition member or insert 52 may take virtually any form. In one alternative embodiment (not shown), five panels radiate from a hub in a star shaped configuration. In another alternative embodiment, three panels radiate from a hub at unequal angles relative to one another (e.g., 150°, 105°, 105°). In another class of alternative embodiments, the configuration of panels need not have a central hub, but may be asymmetrically formed.

In using the storage assembly 51 of Fig. 6, a fluidic (e.g., liquid or colloidal solution) specimen 68 is deposited into vial 50 through an open upper end thereof. Partition member or compartmentalizing insert 52 is then inserted into vial 50 to divide the specimen 68 into four equivalent portions (not separately labeled). Cap 62, being attached to partition member or insert 52, is wedged or screwed into the upper end of vial 50 simultaneously with the insertion of partition member or insert 52 into the vial. After lowering the temperature of the filled storage assembly 51 so that specimen 68 becomes frozen, it may be desired to extract a portion (one-quarter) of the specimen for testing purposes, while leaving the other three portions of the specimen in vial 50. To that end, cap 62 is removed from vial 50 and partition member or insert 52 pulled from the vial, while a restraint is placed on the three portions of the specimen 68 to remain in vial 50. The test sample is removed from vial 50 together with the partition member or insert 52. Subsequently, a new partition member or compartmentalizing insert 52 may be placed into vial 50 (with a respective cap 62) to ensure continued separation of the remaining three portions of specimen 68 particularly in the event that those portions are to be utilized separately. To facilitate the extraction of a sample specimen portion from vial 50, a tool may be provided such as a leveraged grasper (not shown) with three parallel retention fingers (with sterile tips).

It is to be noted that partition panels 54-57 may each be provided at a opposite ends with a lower aperture and an upper aperture (not shown) for flow facilitation purposes. These apertures are respectively located below and above an interface surface between specimen 68 and air in the vial's storage chamber, as discussed above with reference to Figs. 1-3. The lower aperture may simply be a passageway (not shown) between a lower edge of the panel and the inner surface of vial 50.

Figs. 9-13 illustrate a segmented cryogenic container assembly 70 including a main vial or ampule 72 and a plurality of partition members 74-77 in the form of wedge-shaped ampules or receptacle inserts. Partition members or receptacle inserts 74-77 each define a respective specimen-receiving compartment of container assembly 70. A cap 80 is provided to close vial or ampule 72 via a threaded coupling. In use of the cryogenic container assembly 70 of Fig. 9, partition members or receptacle inserts 74-77 are placed in vial 72 and subsequently a fluidic or liquid specimen 82 is deposited into partition members or receptacle inserts 74-77. Cap 80 is then screwed into the open end of vial 72. After lowering the temperature of the filled container assembly 70 so that the various portions of specimen 82 in partition members or receptacle inserts 74-77 become frozen, it may be desired to remove a portion (one-quarter) of the specimen for testing purposes, while leaving the other three portions of the specimen in vial 72. To that end, cap 80 is removed from vial 72 and one of the partition members or inserts 74-76 or 77 pulled from the vial. Partition members or receptacle inserts 74-77 may be tapered to facilitate their extraction from vial 72. If necessary, a retraint may be placed on the other three partition members or inserts 74-77 which are to remain in vial 72. The test sample is removed from vial 72 together with the respective partition member or insert 74-76 or 77. Optionally an empty partition member or insert identical to the removed one may be placed into vial 72. As depicted in Figs. 14-16, each partition member or receptacle insert 74-77 (74 shown) may be provided in a lower end with an aperture 84. At their upper ends, partition members or inserts 74-77 are open mouthed and thus provided with respective upper apertures 86. Apertures 84 and 86 facilitate the transfer or diffusion of the material of specimen 82 between the different compartments defined by partition members or receptacle inserts 74-77.

As shown in Fig. 11 , partition members or receptacle inserts 74-77 fit together like slices of a pie, at least at the upper portions of inserts. Partition members or inserts 74-77 may have different shapes and numbers other than those depicted in Figs. 9-15. For example, container assembly 70 may include only two receptacle inserts each having a semicylindrical cross-section (not shown). Alternatively, container assembly 70 may include exactly three receptacle inserts (not shown), one having a semicylindrical cross-section and the other two having quarter-cylindrical cross-sections. In another alternative configuration (not shown), a central receptacle insert may be cylindrical with two or more outer receptacle inserts each having a cross-section in the form of an annular segment. Thus, many different insert configurations are within contemplation of the instant invention.

Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.

Claims

CLAIMS:

1. A method for storing biological specimens at low temperatures and faciltiating selective retrieval of the specimens, comprising: providing a vial defining a storage chamber having a plurality of intercommunicating compartments and containing a single fluidic specimen disposed in said chamber and distributed among said compartments; subjecting the vial with the specimen to low temperatures; by virtue of subjecting the vial with the specimen to low temperatures, freezing portions of said specimen disposed in respective ones of said compartments; and subsequent to the freezing of said portions of said specimen in said compartments, removing one of said portions of said specimen from a respective one of said compartments while maintaining another of said portions of said specimen in said chamber.

2. The method defined in claim 1 wherein the providing of said vial includes: depositing said fluidic specimen in said chamber; subdividing said chamber into said compartments; and allowing the deposited specimen to flow into the different compartments to form said portions of said specimen in said compartments.

3. The method defined in claim 2 wherein the subdividing of said chamber includes inserting at least one divider or partition member into said chamber.

4. The method defined in claim 3 wherein said divider or partition member is connected to a cap of said vial, further comprising attaching said cap to said vial after inserting said divider or partition member into said chamber.

5. The method defined in claim 3 wherein said divider or partition member is one of a plurality of divider or partition members each in the form of a separate container defining a respective one of said compartments, the subdividing of said chamber including inserting all of the containers into said chamber.

6. The method defined in claim 3 wherein said divider or partition member is formed with a first aperture and a second aperture, said specimen being deposited into said chamber in such an amount that said first aperture is disposed above an upper level of said specimen in said chamber and said second aperture is disposed below said upper level of said specimen in said chamber, whereby the deposited specimen is allowed to flow into said compartments to form said portions of said specimen in said compartments.

7. The method defined in claim 3 wherein said divider or partition member is inserted into said compartment after the depositing of said specimen in said chamber.

8. The method defined in claim 3 wherein said divider or partition member is inserted into said compartment prior to the depositing of said specimen in said chamber.

9. The method defined in claim 2 wherein the subdividing of said chamber is performed prior to the depositing of said specimen in said chamber.

10. The method defined in claim 1 wherein said specimen is a single homogeneous sample so that each of said portions of said specimen is effectively identical to the other of said portions of said specimen.

11. A container assembly comprising a vial or ampule having a storage chamber for storing biological specimens at low temperatures, said vial or ampule containing at least one partition member subdividing said chamber into a plurality of intercommunicating storage compartments.

12. The assembly defined in claim 11 , further comprising a cap attached to said vial for closing said chamber, said partition member being connected to said cap.

13. The assembly defined in claim 12 wherein said partition member includes an elongate hollow element provided with a first aperture at an end spaced from said cap and a second aperture disposed more proximally to said cap.

14. The assembly defined in claim 13 wherein said hollow element is tapered.

15. The assembly defined in claim 12 wherein said partition member includes an elongate hollow element provided with a slot extending longitudinally along said hollow element.

16. The assembly defined in claim 15 wherein said hollow element is tapered.

17. The assembly defined in claim 12 wherein said partition member includes a flat elongate panel extending from said cap.

18. The assembly defined in claim 17 wherein said panel is one of a plurality of panels connected to one another along an axis of said cap.

19. The assembly defined in claim 11 wherein said partition member is one of a plurality of partition members each in the form of a separate receptacle inserted in said chamber to define a respective one of said compartments.

20. The assembly defined in claim 19 wherein the containers are tapered.

21. The assembly defined in claim 11 wherein said partition member is formed with a first aperture and a second aperture spaced from one another to define a fluid flow path for enabling a filling of lower parts of said compartments with respective portions of a fluidic specimen.

22. The assembly defined in claim 11 , further comprising a single fluidic specimen disposed in said chamber so that essentially identical portions of said specimen are located in different ones of said compartments.

23. The assembly defined in claim 22 wherein said specimen is a single homogeneous sample so that each of said portions of said specimen is effectively identical to the other of said portions of said specimen.

24. A container assembly for storing biological specimens at low temperatures, comprising: an outer vial defining a storage chamber; and partition means disposed in said vial for dividing said storage chamber into a plurality of intercommunicating spaces so that a single fluidic specimen in said chamber is disposable in part in each of said spaces prior to a cooling operation and so that subsequently a frozen portion of said specimen disposed in one of said spaces may be removed from said vial separately from a remainder of said specimen disposed in another of said spaces.

25. The assembly defined in claim 24, further comprising a cap attached to said vial for closing said chamber, said partition means being connected to said cap.

26. The assembly defined in claim 25 wherein said partition means includes an elongate hollow element provided with a first aperture at an end spaced from said cap and a second aperture disposed more proximally to said cap.

27. The assembly defined in claim 26 wherein said hollow element is tapered.

28. The assembly defined in claim 25 wherein said partition means includes an elongate hollow element provided with a slot extending longitudinally along said hollow element.

29. The assembly defined in claim 28 wherein said hollow element is tapered.

30. The assembly defined in claim 25 wherein said partition means includes a flat elongate panel extending from said cap.

31. The assembly defined in claim 30 wherein said panel is one of a plurality of panels connected to one another along an axis of said cap.

32. The assembly defined in claim 24 wherein said partition means includes a plurality of partition members each in the form of a separate container inserted in said chamber to define a respective one of said compartments.

33. The assembly defined in claim 32 wherein the containers are tapered.

34. The assembly defined in claim 24 wherein said partition means is provided with a first aperture and a second aperture spaced from one another to define a fluid flow path for enabling a filling of lower parts of said compartments with respective portions of a fluidic specimen.

35. The assembly defined in claim 24, further comprising a single fluidic specimen disposed in said chamber so that essentially identical portions of said specimen are located in different ones of said compartments.

36. The assembly defined in claim 35 wherein said specimen is a single homogeneous sample so that each of said portions of said specimen is effectively identical to the other of said portions of said specimen.

37. A container assembly comprising a vial or ampule having a storage chamber for storing biological specimens at low temperatures, said vial or ampule containing a plurality of elongate receptacle inserts subdividing said chamber into a plurality of storage compartments.

38. The assembly defined in claim 37 wherein said receptacle inserts each have a cross-section in the shape of a pie slice, the receptacle inserts fitting together in a circular configuration.

39. The assembly defined in claim 37 wherein said receptacle inserts are open at an upper side and thus communicate with one another.