Registers – Systems controlled by data bearing records – Mechanized store
Reexamination Certificate
1997-06-16
2001-10-16
Frech, Karl D. (Department: 2876)
Registers
Systems controlled by data bearing records
Mechanized store
C235S375000
Reexamination Certificate
active
06302327
ABSTRACT:
FIELD OF THE INVENTION
The following invention relates generally to a method and apparatus for storing a plurality of thermolabile products in a cold, preserving medium including storage addresses for each product in a cold storage dewar. Each product stored has a unique identity which correlates with both its source of origin and its location in the dewar. The device includes means for reading at least one of those identities. More specifically, this device especially enables tissue, DNA specimens, laboratory assays, certain blood products and especially white blood cells to be cryoprotected, decreased in temperature at a preprogrammed, controlled rate stored and subsequently accessed upon appropriate identification to be surrendered for subsequent use.
BACKGROUND OF THE INVENTION
This application chronicles the ongoing evolution of assignee's cryogenic storage device described in Ser. No. 08/393,558 filed Feb. 23, 1995. The need to save thermolabile products, especially in the field of medicine and for its evidentiary value in law, continues to increase. Tissue sample, DNA specimens and laboratory assays are all examples of substances which, once studied, typed and matched are suitable candidates for subsequent storage should the need ever arise for further analysis. Products which can degrade as a function of time and temperature have little archival value unless properly preserved and maintained.
Significant advances in the state of the art in blood cell research, especially sequestering and preserving white blood cells and the discovery that these cells can be used between unrelated donors and recipients, has created a need for a reliable freezing and storage device for the blood products, especially blood cells to maintain their quality prior to utilization. Although there is no longer an absolute requirement that donors and recipients be related, matching characteristics of the donor and the recipient presently optimizes the likelihood of acceptance by the recipient rather than rejection. Based on a multiplicity of factors, it is estimated that optimally matching a donor to a recipient may require selecting from an aggregation of donor specimens numbering in the thousands or even hundreds of thousands.
The problem associated with storing large numbers of donor's products is that they are thermolabile and therefore can degrade as a function of time when they are not frozen at a controlled rate and then maintained in an extremely low-temperature, controlled environment. Equally as important, once the products are stored in the appropriate low temperature environment, it is still highly desirable that the product remain stable and undisturbed at that temperature until the product is to be used. This assures the highest quality.
These foregoing considerations provide considerable engineering problems, especially should the products be stored at temperatures where nitrogen is the cold storage liquid, because mechanisms working in such an operating environment would have to be durable at −190° C. At such low temperatures, tasks which are relatively simple at room temperature, e.g. storing, selecting and removing products provide difficulties. Mechanical implements can be prone to failure at extremely low temperatures. Should there be a mechanical failure without adequate accommodation for some type of system redundancy, there can be dire consequences both as to timely treatment and as to maintaining product quality because of failure to access or maintain the product at a constant temperature.
The following patents reflect the state of the art of which applicant is aware insofar as these patents appear germane to the process at hand. However, it is stipulated that none of these patents singly nor when considered in any conceivable combination teach the nexus of the instant invention as set forth hereinabove and as particularly claimed.
PATENT NO.
ISSUE DATE
INVENTOR
U.S. PATENT DOCUMENTS
3,662,565
May 16, 1972
Gram
4,090,374
May 23, 1978
Faust, et al.
4,245,483
January 20, 1981
Murai
4,432,214
February 21, 1984
Richelli, et al.
4,920,763
May 1, 1990
Provest, et al.
5,125,240
June 30, 1992
Knippscheer, et al.
5,176,202
January 5, 1993
Richard
5,233,844
August 10, 1993
Richard
FOREIGN PATENT DOCUMENTS
EP0 411 224 A2
February 2, 1991
Knippscheer, et al.
WO91/02202
February 21, 1991
Richard
WO91/02203
February 21, 1991
Knippscheer, et al.
WO91/09521
July 11, 1991
Richard
WO92/16800
October 1, 1992
Knippscheer, et al.
WO93/03891
March 4, 1993
Knippscheer, et al.
JP4-507,283
December 17, 1992
Knippscheer, et al.
JP6-509,782
November 2, 1994
Knippscheer, et al.
The several patents to Knippscheer, et al. teach the use of a storage device for cryoprotecting thermolabile products including means for selectively extracting certain products upon demand. All these prior art teachings can be collectively characterized as requiring complex mechanical mechanisms whose moving components are required to perform reliably at a temperature in which liquid nitrogen is intended to be present. Because relative motion of mechanical implements is described, maintenance, repair and lubrication of the implements and reliability at such low temperatures is a grave concern. The instant invention is distinguished over the Knippscheer, et al. patents, inter alia, in that no moving components have drive mechanisms that contact or operate directly in the liquid nitrogen.
SUMMARY OF THE INVENTION
The instant invention solves the problems which plague the prior art in a multiplicity of ways. The instant invention provides a sealed dewar having a series of annular racks, preferably cylindrical in configuration and concentrically disposed therewithin. Each of the racks is maintained in a fixed position with respect to peripheral walls of the dewar. Liquid nitrogen covers the racks. Each annular rack is separated one from the other by an annular passageway. The annular passageways provide access to the racks and therefore to thermolabile products which are stored in the racks.
Head space is provided between a surface of the liquid nitrogen and an uppermost extremity of the dewar. The head space is provided with nitrogen gas to form a gas cap to continue maintaining a low temperature. An access portal is also located above the liquid level to communicate with the ambient conditions.
The upper extremity of the dewar is closed. The enclosure may include the following structure. First, the overlying enclosure is sealed. Specifically, a lid overlies the topmost extremity of the dewar. This lid prevents the nitrogen gas from escaping and provides a thermal barrier. Insulation is also provided in the lid. Thus, the lid provides a barrier to prevent both heat and ambient moisture contained in air from migrating into the dewar.
Second, the enclosure provides a support structure for a robotic arm drive mechanism. A robotic arm connects to the drive mechanism and extends through the lid to access the racks and the thermolabile products contained in the racks via the annular passageways. The robotic arm can move to selected sites in the racks and transfer thermolabile products from the racks to the access portal located on the lid and back. The robotic arm also includes an indexing mechanism which initializes and orients the arm with respect to its position vis-a-vis a reference, which perhaps is fixed in the dewar. The robotic arm includes means for reading indicia either contained on an exposed surface of the thermolabile product, or on a holder which encapsulates the thermolabile product. The robotic arm transmits that information from the thermolabile product or holder to a remote reading and memory site. The desirability of orienting and indexing of the robotic arm, coupled with its remote reading and memory capability increases the likelihood that only the desired thermolabile product is extracted from the dewar. In the case of insertion of the thermolabile product into the dewar, the storage address of the thermolabile product will be known.
OBJECTS OF THE INVENTION
Accordingly, it is a primary object
Buckley Mark
Coelho Philip H.
Pelletier Kevin
Rubinstein Pablo
Frech Karl D.
Kreten Bernhard
ThermoGenesis Corp.
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