United States Patent [19]
`Coelho et al.
`
`[54] METHOD AND APPARATUS FOR
`CRYOGENIC STORAGE OF
`THERMOLABILE PRODUCTS
`
`[75]
`
`Inventors: Philip Henry Coelho, ElDorado Hills;
`Terry Wolf, Placerville, both of Calif.;
`Pablo Rubinstein, New Rochelle, N.Y.
`
`[73] Assignee: ThermoGenesis Corporation, Rancho
`Cordova, Calif.
`
`[21] Appl. No.: 393,558
`
`Feb. 23, 1995
`
`[22] Filed:
`Int. Cl.6
`...................................................... F25B 19/00
`[51]
`[52] U.S. Cl .................................... 62/51.1; 62/64; 62/337
`[58] Field of Search .............................. 62/341, 337, 378,
`62/64, 62, 51.1
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,662,565
`4,090,374
`4,245,483
`4,432,214
`4,920,763
`5,125,240
`5,233,844
`
`5/1972 Gram ........................................ 62/345
`5/1978 Faust et al ................................ 62/341
`1/1981 Murai ........................................ 62/376
`2/1984 Richelli et al ............................ 62/341
`5/1990 Provest et al. ............................ 62/378
`6/1992 Knippscheer et al ..................... 62/266
`8/1993 Knippsheer et al ...................... 62/345
`
`FOREIGN PATENT DOCUMENTS
`
`2/1991 European Pat. Off ........... F25D 3/11
`0411224
`4507283 12/1992
`Japan ................................ F25D 3/11
`
`111111
`
`1111111111111111111111111111111111111111111111111111111111111
`US005638686A
`[111 Patent Number:
`[451 Date of Patent:
`
`5,638,686
`Jun. 17, 1997
`
`Japan ............................... B65G 1/02
`6509782 1111994
`2/1991 WIPO ............................. F25D 23/02
`9102203
`9102202
`2/1991 WIPO ............................. F25D 23/02
`9109521
`7/1991 WIPO .............................. A01N 1/02
`9216800 10/1992 WIPO ............................. F25B 29/00
`9303891
`3/1993 WIPO .............................. B25G 1100
`
`Primary Examiner-Ronald C. Capossela
`Attorney, Agent, or Firm-Bernhard Kreten
`
`[57]
`
`ABSTRACT
`
`A device for cryoprotecting thermolabile products. A con(cid:173)
`tainer (20) receives an annular rack (40) which is sealed by
`an enclosure (60). The enclosure (60) includes an outer
`stationary toroid (70) and a rotatable core (90). A robotic
`arm (160) is adapted to move and is supported by the core
`(90). The robotic arm (160) accesses an interior of the
`enclosure (60). An access portal (80) allows removal and
`placement of thermolabile products constrained by a holder
`(150). The robotic arm (160) accesses product and holder
`(150) and embarks upon controlled freezing of the product
`and its location in the rack ( 40) until subsequent retrieval. A
`computer controls the rate of freezing and stores in memory
`the location of all of the stored products. The robotic arm
`(160) reads the product in storage to assure the correct
`product is being accessed.
`
`87 Claims, 13 Drawing Sheets
`
`Hamilton Ex. 1034
`Page 1
`
`

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`Hamilton Ex. 1034
`Page 2
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`

`

`U.S. Patent
`
`Jun. 17, 1997
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`5,638,686
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`Page 3
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`Page 4
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`

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`U.S. Patent
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`Jun. 17, 1997
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`Jun. 17, 1997
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`Page 8
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`U.S. Patent
`
`Jun. 17, 1997
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`Hamilton Ex. 1034
`Page 10
`
`

`

`U.S. Patent
`
`Jun. 17, 1997
`
`Sheet 10 of 13
`
`5,638,686
`
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`Hamilton Ex. 1034
`Page 11
`
`

`

`U.S. Patent
`
`Jun. 17, 1997
`
`Sheet 11 of 13
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`5,638,686
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`Page 12
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`CRF STOPPED
`
`BAG & CARTRIDGE ( 1 0% DMSO BY VOLUME)
`STEM CELL FREEZING
`INCA/NYBC
`
`IN WELL: -140'C
`
`AMBIENT TEMPERATURE
`
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`
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`Page 13
`
`

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`Hamilton Ex. 1034
`Page 14
`
`

`

`1
`METHOD AND APPARATUS FOR
`CRYOGENIC STORAGE OF
`THERMOLABILE PRODUCTS
`FIELD OF THE INVENITON
`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 container. Each product stored
`has a unique identity which correlates with both its source of
`origin and its location in the container. The device includes
`means for reading 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 15
`preprogrammed, controlled rate stored and subsequently
`accessed upon appropriate identification to be surrendered
`for subsequent use.
`
`5,638,686
`
`2
`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
`5 combination teach the nexus of the instant invention as set
`forth hereinabove and as particularly claimed.
`
`10 U.S. Pat. No.
`
`U.S. PAIENT DOCUMENTS
`
`ISSUE DA1E
`
`INVENTOR
`
`5,125,240
`5,233,844
`
`Knippscheer, et al.
`June 30, 1992
`August 10, 1993
`Richard
`FOREIGN PAIENT DOCUMENTS
`
`EPO 411 224 A2
`W091/02202
`W091/02203
`W091/09521
`W092/16800
`W093/03891
`20 JP4-507 ,283
`JP6-509,782
`
`February 2, 1991
`February 21, 1991
`February 21, 1991
`July 11, 1991
`October 1, 1992
`March 4, 1993
`December 17, 1992
`November 2, 1994
`
`Knippscheer, et al.
`Richard
`Knippscheer, et al.
`Richard
`Knippscheer, et al.
`Knippscheer, et al.
`Knippscheer, et al.
`Knippscheer, et a!.
`
`BACKGROUND OF THE INVENITON
`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 25
`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 30
`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 35
`utilization. Although there is no longer an absolute require(cid:173)
`ment that donors and recipients be related, matching char(cid:173)
`acteristics 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 40
`that optimally matching a donor to a recipient may require
`selecting from an aggregation of donor specimens number(cid:173)
`ing 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 45
`can degrade as a function of time when they are not frozen
`at a controlled rate and then maintained in an extremely
`lowtemperature, controlled environment. Equally as
`important, once the products are stored in the appropriate
`low temperature environment, it is still highly desirable that 50
`the product remain stable and undisturbed at that tempera(cid:173)
`ture until the product is to be used. This assures the highest
`quality.
`These foregoing considerations provide considerable
`engineering problems, especially should the products be 55
`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 conse(cid:173)
`quences 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 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 collec(cid:173)
`tively 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 mechani(cid:173)
`cal implements is described, maintenance, repair and lubri(cid:173)
`cation of the implements and reliability at such low tem(cid:173)
`peratures 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 INVENITON
`The instant invention solves the problems which plague
`the prior art in a multiplicity of ways. The instant invention
`provides a sealed container having a series of annular racks
`concentrically disposed therewithin. Each of the racks is
`maintained in a fixed position with respect to peripheral
`walls of the container. 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 container. The
`head space is provided with nitrogen gas to continue main(cid:173)
`taining a low temperature. An access portal is also located
`above the liquid level to communicate with the ambient
`conditions.
`The upper extremity of the container is closed. The
`enclosure may include the following structure. First, the
`overlying enclosure is sealed to form a gas cap. Specifically,
`a first platen overlies the topmost extremity of the container.
`This first platen prevents the nitrogen gas from escaping and
`60 provides a thermal barrier. An insulating space also exists
`above the platen. The enclosure circumscribes and overlies
`both a topmost portion of the container and the entire platen.
`Collectively, the enclosure and platen provide barriers to
`prevent both heat and ambient moisture contained in air
`65 from migrating into the container.
`Second, the enclosure provides a support structure for a
`robotic arm drive mechanism. A robotic arm connects to the
`
`Hamilton Ex. 1034
`Page 15
`
`

`

`5,638,686
`
`3
`drive mechanism and extends through the platen 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 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 container.
`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 container.
`In the case of insertion of the thermolabile product into the
`container, the storage address of the thermolabile product
`will be known.
`
`OBJECTS OF THE INVENTION
`Accordingly, it is a primary object of the present invention
`to provide a new, novel and useful method and apparatus for
`cryogenic storage of thermolabile products.
`A further object of the present invention is to provide a
`device as characterized above which is extremely durable in
`construction, safe to use, and lends itself to mass production.
`A further object of the present invention is to provide a
`device as characterized above in which the extreme low
`temperature operating environment is below all moving
`machinery associated therewith for added reliability and
`freedom from maintenance problems.
`A further object of the present invention is to provide a
`device as characterized above in which thermolabile prod(cid:173)
`ucts that are stored at cryogenic temperatures can be del(cid:173)
`egated to a specific address in the storage device and remain
`there until subsequently needed.
`A further object of the present invention is to provide a
`device as characterized above in which each thermolabile
`product contained in storage is first scanned for verification
`purposes to increase the likelihood that only the correct
`product is being removed from storage so as to prevent
`unwanted temperature excursions, particularly temperature 45
`elevations, of the product
`A further object of the present invention is to provide a
`device as characterized above in which each thermolabile
`product contained in storage is first scanned prior to removal
`to increase the likelihood that only the correct product is 50
`being removed from storage so as to minimize any physical
`disturbance of the product until such removal is desired.
`Viewed from a first vantage point it is an object of the
`present invention to provide a device for storing and access(cid:173)
`ing thermolabile products, comprising, in combination: a 55
`container, liquid in the container, means for maintaining the
`liquid at a depressed temperature, an annular storage rack
`disposed in the liquid in the container and including plural
`compartments dimensioned such that one thermolabile prod(cid:173)
`uct can be received in any one of the plural compartments, 60
`an access portal located above the liquid and communicating
`outside the device, and means for transporting the thermo(cid:173)
`labile products to and from the compartments and the access
`portal.
`Viewed from a second vantage point it is an object of the 65
`present invention to provide a method for storing and
`retrieving thermolabile products, the steps including orient-
`
`4
`ing the thermolabile product adjacent the container, allowing
`the thermolabile product to enter the container, grasping the
`thermolabile product with a robotic arm, allowing the ther(cid:173)
`molabile product to decrease in temperature at a controlled
`5 rate, storing the thermolabile product in a specific site,
`memorizing the location of the specific site and subse(cid:173)
`quently retrieving the thermolabile product by recalling the
`specific site of the thermolabile product, directing the
`robotic arm to the memorized site of the thermolabile
`10 product, verifying that the desired thermolabile product has
`indeed been identified at the memorized site, attaching the
`robotic arm to the thermolabile product, and delivering the
`thermolabile product to an exterior of the container.
`Viewed from a third vantage point it is an object of the
`15 present invention to provide a holder for a thermolabile
`product which allows the thermolabile product to be con(cid:173)
`tacted by a robotic arm, comprising, in combination: means
`for attaching said holder to said thermolabile product and
`means for attaching said thermolabile product to said robotic
`20 arm through said holder.
`Viewed from a fourth vantage point it is an object of the
`present invention to provide a holder to allow a thermolabile
`product to be accessed by a robotic arm, comprising, in
`combination: said holder having indicia associated therewith
`25 correlative of indicia on said thermolabile product and
`means on said robotic arm for reading said indicia.
`Viewed from a fifth vantage point it is an object of the
`present invention to provide a cryogenic device comprising
`30 a robotic arm adapted to move between a first position and
`a second position, said first position accessing thermolabile
`product which is stored at depressed temperatures, said
`second position adapted to allow said thermolabile products
`access to ambient conditions, and remote reading means
`35 operatively coupled to said robotic arm for assuring a correct
`thermolabile product has been selected by said robotic ann.
`Viewed from a sixth vantage point it is an object of the
`present invention to provide a unitary cryogenic device
`which both freezes a thermolabile product at a controlled
`40 rate and stores the frozen product.
`Viewed from a seventh vantage point it is an object of the
`present invention to provide a thermolabile product in a
`black box holder and expose the holder and product through
`a controlled rate temperature excursion.
`These and other objects will be made manifest when
`considering the following detailed specification when taken
`in conjunction with the appended drawing figures.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is sectional view along a vertical plane at a
`diameter of the device.
`FIG. 2 is an exploded parts view of that which is shown
`in FIG. 1.
`FIG. 3 is a top view with certain interior portions exposed.
`FIG. 4 is a perspective view of one of the interior storage
`shelves showing access to both sides thereof.
`FIG. 5 is a side perspective view of a portion of the FIG.
`4 shelf with the compartment removed.
`FIG. 6 is a sectional view of upper right-hand toroid of
`FIG.1.
`FIG. 7 is greater detail of that which is shown in FIG. 6.
`FIG. 8 is a sectional view of an access portal shown in
`FIG. 1 with an elevator in an "up" position.
`FIG. 9 is a sectional view of an access portal shown in
`FIG. 1 with an elevator in an "down" position.
`
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`Page 16
`
`

`

`5,638,686
`
`5
`FIG. 10 is a sectional view of a distended seal on a platen.
`FIG. 11 is a sectional view of a seal on the platen.
`FIG. 12 is perspective view of the platen.
`FIG. 13 is a top view of the device.
`FIG. 14 is a top view of the device.
`FIG. 15 is a side view of a portion of the top.
`FIG. 16 is a perspective view of a motor drive used in the
`device.
`FIG. 17 is a perspective view of the holder and product. 10
`FIG. 18 is a perspective view of the robotic arm and head
`accessing a holder.
`FIG. 19 is a perspective view of the robotic arm and head
`grasping a holder.
`FIG. 20A is one algorit'un showing the benefit of con(cid:173)
`trolled rate freezing as a function of temperature.
`FIG. 20B is another algorithm showing the benefit of
`controlled rate freezing as a function of temperature.
`
`6
`bore of the container 20. Thus, the rack 40 lends itself to
`slideable insertion within the blind bore of the container 20
`and to rest therewithin. Double ended arrow A of FIG. 2
`reflects the direction of removable insertion and extraction
`5 with respect to the container 20.
`The rack 40 includes a peripheral wall 22 having at its
`topmost extremity a downwardly open substantially "U''(cid:173)
`shaped rack support 24. The U -shaped rack support 24 faces
`outwardly and is oriented to overlie a topmost edge 16 of the
`container 20. The rack support 24 includes a bight portion
`24a and a downwardly extending leg 24b adapted to straddle
`the exterior of the container 20 in conjunction with the
`peripheral wall 22.
`In addition, the rack 40 may be supported by means of
`15 plural feet 26 projecting downwardly from the peripheral
`wall 22 so that rack 40 rests upon the upper concave surface
`of the bottom 4 of the container 20. The rack 40 includes a
`floor 28 which is substantially circular and may be formed
`from a plate or a plurality of ribs which form a network
`20 extending to the peripheral wall 22. For example, FIG. 3
`shows a plurality of radially extending ribs 28 as one floor
`embodiment connecting the peripheral wall 22 and provid(cid:173)
`ing support for a series of concentrically disposed arrays of
`compartments 32. The arrays of annular compartments are
`25 separated from one another towards the geometrical center
`of the rack 40 by means of annular passageways 30. The
`centralmost passageway is a cylinder. Thus, given the
`dimensions of one commercial container 20, a series of four
`concentrically disposed arrays of compartments are shown
`30 and provided having the configuration.
`As shown in FIGS. 4 and 5, the plurality of compartments
`32 have a bottom shelf 34 with a peripheral lip 36 at both
`inboard and outboard arcuate edges thereof. The compart-
`35 ments 32 may be provided with partitions 33 that allow
`holders 150 to be held in fixed position within the storage
`rack 40. The compartments 32 are formed from one con(cid:173)
`tinuous sheet contoured as a serpentine wall with partitions
`33 connected by ends 35. Access openings 31 allow holders
`40 150 to be alternately facing adjacent passageways 30.
`As shown in FIG. 3, for example, the outermost shelf (i.e.
`that which is immediately adjacent the peripheral wall 22)
`stores the holders 150 such that the outboardmost annular
`passageway 30 faces these holders 150. The successive
`45 inwardly directed three sets of shelves 34, however, support
`compartments 32 that open on both an interior arcuate edge
`of the shelf 34 and an exterior arcuate edge of the shelf as
`shown in FIGS. 4 and 5. This allows the holders 150 to be
`interleaved with respect to adjacent holders 150 thereby
`50 increasing the density of the number of holders capable of
`being inserted. The interleaving benefits from the fact that
`the holders 150 have a wedge-shaped contour which accom(cid:173)
`modates the wedge-shaped contour of each compartment 32.
`Only the shelves 34 nearest wall 2 do not benefit from this
`55 interleaving feature.
`Attention is now directed to FIGS. 1, 2 and 6 through 10.
`These drawings reflect certain other details with respect to
`the enclosure 60 which overlies the container 20 and asso(cid:173)
`ciated storage rack 40. As briefly mentioned, supra, the
`60 enclosure 60 serves as a support for both the access portal
`80, the transporting means 100 and for the robotic arm 160.
`One hallmark of the enclosure is that it can be removed as
`a monolith as suggested in FIG. 2 so that, should the
`container 20 leak or require replacement for some other
`65 reason, the rack 40 can be moved as one entity and all of the
`thermolabile product contained therewithin can be expedi(cid:173)
`tiously moved for subsequent storage elsewhere. The enclo-
`
`D~CIDWITONOFP~D
`EMBODIMENTS
`Referring to the drawing, wherein like numerals denote
`like parts throughout the various figures, reference numeral
`10 is directed to the apparatus for the cryogenic establish(cid:173)
`ment and storage of thermolabile products.
`In essence, and with respect to FIGS. 1 and 2 in particular,
`the device 10 includes three major assemblies: a container
`20 adapted to receive liquid nitrogen therewithin, an annular
`rack 40 dimensioned to slideably and nestably fit within an
`interior of the container 20, and an overlying enclosure 60
`which seals the container and the annular rack from ambient
`conditions. At least one access portal 80 is provided, pref(cid:173)
`erably located within the enclosure 60 to allow thermolabile
`product (to be described in detail hereinafter) to be admitted
`and removed from the device 10. The access portal 80
`communicates with a transporting means 100 that includes
`a robotic arm 160 and drive mechanism for moving the
`thermolabile products to and from the access portal 80 and
`the annular storage rack 40.
`More particularly, and with particular reference to FIGS.
`1 and 2, the details of the container 20 can be explained. In
`essence, this container is preferably a commercially avail(cid:173)
`able container conventionally used to store liquid nitrogen
`and is commonly referred to as a "pressure" vessel. Because
`of the extremely low temperature (e.g. -190° C.), the
`container 20 is formed with a peripheral side wall 2 inte(cid:173)
`grally formed with a base 4 having an arcuate bottom
`contour where a convex side of the arcuate contour faces
`downwardly. An interior sectional view of the pressure
`vessel container 20 shows that an interior hollow 6 is
`provided which is maintained at a near vacuum as is
`commercially practicable. This vacuum discourages thermal
`invasion. The hollow 6 may also be filled with foam. Legs
`8 keep the container 20 stable above the ground to preclude
`thermal transfer. Thus, the container 20 is an open topped
`blind bore having a concave bottom interior wall adapted to
`receive liquid nitrogen therewithin. As is common with
`these commercially available pressure vessel containers,
`plumbing in the form of an inlet 12 controlled by valve V
`and an outlet 14 also controlled by a valve V allow for the
`respective adding, replenishing or removing of the liquid
`nitrogen as is needed.
`Referring to FIGS. 1 through 5, details of the annular rack
`40 can be put into perspective. As shown, the annular rack
`40 has an exterior dimension complemental with the interior
`
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`Page 17
`
`

`

`5,638,686
`
`7
`sure 60 includes a stationary toroid 70 which does not move
`relative to the container 20 during normal use and operation.
`The toroid 70 supports the access portal 80. In addition, the
`enclosure 60 includes a central core 90 which is surrounded
`by the toroid 70. The core 90 defines a portion of the 5
`transporting means 100 for the robotics to be described.
`More particularly, the enclosure's stationary toroid 70,
`shown at its righthand portion in F1G. 6, provides a support
`for a motor M1 which is used to drive the core 90 about a
`vertical axis VA which is located at the geometric center of 10
`the apparatus 10 and shown in FlGS. 1 and 2. The toroid 70
`also includes an effective seal to preclude the effect of
`thermal migration. For example, the toroid 70 contacts an
`outer surface 18 of side wall 2, rests upon the bight portion
`24a of the downwardly open U-shaped rack support 24, and 15
`frictionally engages the outboard vertical leg 24b of the
`bight portion. Notice in FlG. 6 that the terminal extremity of
`the vertical leg 24b of the U-shaped rack support includes an
`inwardly directed contacting lip 24c made of insulated
`material to serve as a further barrier against thermal migra- 20
`tion.
`The motor M1 is supported atop a top skin 42 of the toroid
`70. The top skin 42 communicates with a vertically disposed
`outside skin 44. An area of transition, defined by a radiused
`edge 46 communicates between the top skin 42 and the 25
`outside skin 44. Vertical inside skin 48 is parallel to and
`spaced from the vertical outside skin 44. In addition, a
`horizontal bottom skin 50 is disposed at a lowermost
`extremity of the vertical inside skin 48. The horizontal
`bottom skin 50 is adapted to lie atop, seal and distribute 30
`weight onto the U-shaped rack support 24 discussed here(cid:173)
`inabove. In addition, the vertical outside skin 44 extends to
`the same horizontal plane of the lip 24c of the U-shapedrack
`support.
`Because of the extremely low temperature differential 35
`between the operating temperatures of the interior of the
`container 20 and the exterior, a further seal 52 is horizontally
`disposed and located below both the lip 24c and a free end
`of the vertical outside skin 44. This toroidal seal 52 can be
`removably fastened by means of a toroidal tang 58 integrally 40
`formed therewith. Tang 58 is vertically oriented and adapted
`to be removably fastened to an outside surface of the vertical
`outside skin 44. In this way, the enclosure 60 can be
`removed independently from the rack 40 if desired by
`removal of the tang 58 and seal 52. With the horizontally 45
`disposed toroidal seal 52 in place, however, the enclosure 60
`and rack 40 can be removed as one element. The toroidal
`seal 52 is enhanced with respect to its sealing ability by
`means of insulation 54 located directly below the seal 52 and
`held in place by means of a toroidal pad 56 located on a 50
`bottom surface of the insulation 54. The toroidal tang 58 can
`extend all of the way down to the toroidal pad 56 for added
`support. Means for attaching the tang 58 to the vertical
`outside skin 44 can take the form of removable fasteners as
`should now be evident The toroidal pad 56 provides suffi- 55
`cient support so that should the enclosure 60 be removed
`separately from the rack 40, the pad 56 can be load bearing.
`An