CA1067470A - Centrifuge separation device and method - Google Patents

Abstract

ABSTRACT OF THE DISCLOSURE
A centrifuge device and method are provided for separating and/or washing finely-divided solid particulate material suspended in a liquid. The invention is especially useful in so treating blood. The centrifuge forms a dense suspension of blood cells in a plurality of blood cells receiving means evenly spaced about the periphery of a rotatable enclosure. The receiving means have converging walls which at their juncture form a locus of maximum centrifugal force. Wash liquid is passed through the dense suspension of blood cells counter to the direction of the centrifugal force by entry into the blood cell receiving means at the locus of maximum centrifugal force. Independent conduits connect the locus of maximum centrifugal force through an injector to a supply for the wash liquid and, after fully resuspending the blood cells in a suitable resuspending liquid, the resuspended cells exit from the centrifuge via the independent conduits and injector, which have also therefore been washed by the wash liquid. Thus recontamination is avoided. A unitary disposable structure including the enclosure, blood cell receiving means, conduits and injector is also provided.

Description

`~0679~70 `~

~E~RIFUOE SEPARATION AND
WAS~ING DEVICE AND MEr~OD

The present in~ention relates to a centrifuge device and method for separa~ing and/or washing ~inely-divided solid particulate material suspénded ln a 11quid. ~
- ` me device has~particular applicability~where the solid~parti-cula~e material must be substantiall~ completely~recovered or where the particulate~material must be washed or otherwise treated in an isoiated~environment, ~or exampleg in a~sterile environm nt. ~hus, the invention has particular utility in ~;
~ separæting and/or washing biological particulate materia- sus-`~ ; pended in a liquid~ As a pre~erred embodiment, the in~ention relates to an apparatus~and method for washlng blood.

- ~ ~entrifuge dev~ces and methods of the~present ;
nature have been known in the art. These devioes and~methods ; are,~generally,~ aharac~er1zed by their abilities to separate and/or wash very finely divided~particulate material~uspended in a liquid where that particulate material is to be substan-t1all~ conserved~and/or where that particulate material~must be separated or washed in an isolated environment. Devlces and methods o~ this nature, therefore~ ha~e the~r greatest utility in connection with the separatin~ and/or washing o~
- ~ blood and that is also the pre~erred embodiment herein. ThU6 while the invention is o~ broader applicab~lity as ~ndlcated .
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above, the invention will be primarLly described in ~erms of this preferred embodLment for the sake o~ conciseness.
As is well kno~ h~man ~Lood obtained ~rom volun-teer donors o~ten contains constituents which should not be transmitted into the blood stream oP the blood recipient.
~hile it is possible to identi~y blood having these unwanted constituents, it is di~icult to remove those constituents from the blood and the blood is often rendered useless or can be used only ~or less cr~tical application, such as the production O:e plasma and the lik~
The art has proposed various devices and methods ~or washing blood to remove unwanted constituents such as ~contaminants, toxicants~ viruses, medicants, glycerines and the like. Many of these devices and methods center around an operation for separatine the~blood cells, especially the red blood cells, ~rom the plasma and, a~ter washing , .
the blood cells, resuspending the cells in uncontaminated plasma or o~her suitable blood cell resuspending liquid.
' - This is particulærly use~ul for blood bank purposes where common viruses, -such as hepatitis viruses, are washed ~rom the blood and the washed blood can then be used in the blood bank. In another mode of use~ blood conta~ning unwanted medicants, such as barbituates and the like, can be washed and returned to the donor/patient~ Similarly~
allergens and serum proteins can be washed ~rom blood.

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Also, the devices and m~thods can be used to deglycerinate previously ~rozen but thawecL whole bl.oocL (frozen blood has ~lycerin added thereto). Or cellular debris can be removed ~ from ~rhole blood since particles o~ di~Perent densit~es will -~ 5 ~orm dLf~erent layers in a centri~uge as 1s well known.
: Other similar kinds o~ separation a.nd/or washing operatlons .
:can be perLormed with these known deYices:and methodsO :
hile a ~ide variety~o~ devices and methocLs~have been proposed in the art, the most SucCeSSfUl devices are :~ 10 based upon a centri~ugal 5eparation of:the blood cells ~rom the plasma, with subsequent counter-flo~J washing of the blood cells.. For example, whole blood is placed in a centri~uge device~ which, when revolvlng, forces the cells~into discrete areas where the blood;~cell~ are~compacted. ~Thereafter a ~ :
washing solution~ such as a sterile saline solutLon, is passed through~the compacted~blood cells to waæh those;cells~
o~ unwanted constituents, as indicated above.~
The genersl arrangement and operational requirement9 . of such known devices and methods are disclosed in U.S. Patent No. 3,347,454~is~ued to the present inventor. However, the;deviceS and methods of that patent require that the com-. ponents of the device ~Jhich actually contact blood be~either entirely replaced or completely cleansed after each use, since a batch o~ contaminated blood could pass a portion of those c.ontaminates to a succeeding ~atch;o~ blood~processed -106~70 ~ `

in the device, if replacement or cleansing ~f the device is not performed. ~urther, the device is o~ a batch operation character and can process blood onIy at a relative~y low throughput per unit time.
S It was recognized that improvements in the abil~ty to wash succeedin~ batc~es o~ blood uere desired and U.S.
Patent No. 3,561~672, ~ssued to the present inventor, provldes - an improvement of that nature. That patent provides disposable .
receptacles which can receive a plurality of batches o~ blood ~; 10 ~or _imultaneous washing in a s ~ le centrifuge operation.
Independent and ad~ustable pressure heads ~or each of the plu-.
rallt~ o~ batches within the centrifuge are ~rovided to control the ~lows of wash liquid through the respective batches of blood. The disposable unlts include the blood receptacles, ~15 associated conduits and~seal devices. me operatlon o~
this device is described in some detail in CONTINUOUS ~IOW
CEIL WhSHING SY ~EM, Schultz and Bellamy3 TRANSFUSION, Volume 8j No. 5, September-October, 1968,~and a pre-packaged com- ~ I
I b~nation of two receptacles~ associated seal devices and ~ ¦
condults is described in deta~l in A Disposable Counter~ ow System for Washing Er~thoc~es in a Centri~u~al _ ld, Schultz - and Bel}amy, Proc. 12th Congr. Int. Soc.~-Blood Transrr., ~oscow 1969 Bibl. Haemat.~ ~o. 38, Part II, pp. 350-358 (Karger, Basel, l97l).
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674~0 1 Thus, the art has available considerable detail~ of operation, construction and associated equipment for centrifuges of the present nature and those details will not be repeated herein.
While this ability to provide a disposable package and sterilized component system for washing blood is the basis of one o~ the most successful commercial uses of a blood washing apparatus, that arrangement has the disadvantage that only a relatively low number of separate receptacles can be conveniently handled without so severely complicating the disposable unit, the apparatus and the associated equipment as to make the device and method impractical. Indeed, the commercial embodiments thereof contained only two blood receptacles, along with their associated seals and conduits. This results in a relatively low throughput of blood in a time period.
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~067~70 .

- OBJECTS_O~ T~ ~r~TION

There~ore~ in view o~ the above~ it is an object of the invention to provide devices and methods wherein centri-fugal separation and/or washing operations can be per~ormed : 5 with a plurality o~ solid particulate recei~ing receptacles -:: and wherein a continuous separation and/or washing operation ;. ~ may be per~ormed. It is another ob~ect of the in~ention;to provide devices and methQds of the ~oregoing nature which ~ - .
; are pàrticularly adapted for the separation and/ar washing : 10 ~ o~ blood cells~ especially red blood cells, or other blood fractions. It is a ~urther ob~ect o~ the invention to pro-vide devices and methods:o~ the above nature wherein a plu-rality o~ blood cell receiving receptacles are part of~a unitary~disæosable structure. It is a further o~ject o~
the invention to provide such dieposable structure o~ a ;~
design and con~iguration that lt can~be relatively cheaply manufactured~and;conveniently placed ln and removed from a centrifuge apparatus. Other objects~ will be spparent ~rom the ~ollowing disclosure and claims.
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7~70 ' . ` : - ' BRIEF DESCRIPTION 0~ THE r~ TXON

Brie~ly, tho present in~ention provides a centri-fuge apparatus and ~ethod wherein finely-divided solid parti-:
culate material, especially biologlcal particulate material such as blood cells, may be separated and/or washed. The centrifuge apparatus provides means ~or rotating and *hus centri~uging the solid part~culate material, whereby the ~; ~ particulate material is collected in discrete areas~in the - form of a dense euspenslon under the~centri~ugal ~orce ~ exerted in the centri~uge.~ This separation o~ the particulate materlal also allows a washing step to be performed. A
-liquid~ le~s dense than the particulate material, may be passed through the dense suspens~on of particulate material from the outermost periphery toward the axis of rotation o~
the~centrifuge.~ ~This~proYides an~important feature~o~ the presènt invention~where all parts of the particulate material are subJected to the flow or~the liquid therethrough~as opposed~to arrangements in the~prior art, This~ is especially useful~ln washing~contaminants from bIood,~e.g~., whole blood, snd the invention wili be illustrated;with that embodiment.
The centri~uge apparatu ~or separating and~washing blood comprises an enclosure means ~or enclosing snd ~biologically isolæting s quantitg o~ blood~c~ells in s suspending liquid, e.g., plssms~or other~suspending liquid. A rotstion ~means ls pro~ded for rotating the enolosure means about its Iongitudinsl ~e.g., ~erticsl) axis. This establishes s .- :
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1~67470 "
centri~ugal ~orce in the transverse (horizontalj direction o~ A
thè enclosure means, ~hich force is greatest at the periphery 1~
of the enclosure means. A~ injector means is pro~ide~ ~or moving ~i liquids into and out of the enclosure means. These liqu~ds include the liquid~suspended blood-c~ells and the wash liqulds.
The in~ector means moves the liquids in and ~QUt o$ the en-closure means in a manner`which keeps the system biologlcally isolated, e.g., sterile. A seal means ~s provided ~or~sealing the injector means to the enclosùre means Ln a li~u~d~tight relationship. Thus, liquids can be moved into and out of the~
rotating enclosure means by way o~ the in~ector means because of the liquid tight seal whloh seals the in~ector means to the enclosure means. Accordingly, a continuous ~ shing system can thereby be provided, 15~ ~ As a very importa~ ~feature o~ the~invention, there is~provided a plurality o~ angularly :sha~ed blood cell recelvi~g means which are evenly spaced;about the longitudinal perlphery of the enclosure~means. Any number o~ such receiving means .
may be used, e.g., 2 to 100 or~more, especially 4 to I2,~and particularly 6~to 8, so long as the receiving mean ;have approx~nately e~ual radians~or parts thereof between each ad~acent rece~vlng means ~n order to provide acceptable;balance in the rotating centrifuge. These angularly shaped~blood cell receiv~ng means ~orm at least a part o~ the outer periphery of the enclosure means. To provide the angular shape, there :. : ~ ~

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~ 1067470 ~-~ must be at le~st one pair of opposed wall portions of the blood cell recelving means which converge toward the longitudina periphery of the enclosure means. Any number of pairs o~
converging wall portion m ay be used~ e.g., from 1 to lOO or more, i.e., a conical shape of the receiving~means has an in~lnite number o~ converging ~ 11 portions. ~owever, ~n . . : ~ .
~ non-conical shapes l to 10 pairs,~especially 2 to 6 palrs are , ................................ . , ~ , ~ preferred. At or about the apexes formed by juncture of the ; ~ ~ converging ~all portions~,~there~is established ~locus of `~ 10 maximum ce~trifugal ~orce in the rotatlng enclosure.~ mus, - the blood cells will be separated from at least some of ths plasma and, thus, at least ~orm a dense suspension ~n this angularly shaped receqving~ means and the maximum density of the suspension will be at~the 1 0CUB of m~ximum centrifugal ~; 15 force~. ~The angles~ of convergence can ef~ect the effic1ency of separation of~lood cells;~from plas~ and~ thus, the density o~ the suspension of the blood;cells. Angles between 20~and ~ 135~ eepec1ally between~35~and 115 are pre~erred. Usually, ;~ angles less than 90' will be used. Within~these ranges o~:
~; 20 angles (along with the angular speed o~ r~ation )the density of the sus~ension may vary considerably. In~any case, however, the blo~d cells are compacted ~i.e., contained in a small volume) and for the sake of simplicity the compactlon w~ll be hereinafter referenced. ~ ~
- 25 As another important feature o~ the invention, there is provided a plurality of independent conduit means,~

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' ' ~ , ~067470 each o~ which has one end connec~ed to t~e in~ector means - and the other end connected to the locus of maximum centri-~ugal ~orce in the angularly shaped blood cell recelving means.
Thus, there is provided an independent and separated ~luid passageway ~rom the in~ector means to the locus of maximum ` centri~ugal ~orce.
; Power means for rotating the rotat~on means and :~ enclosure means are provided. The speed o~ angular rotation should be sufficient to separate the blood cells ~rom tbe suspcnding lL~Uid and compact the blood cells~in the blood cell receiving means.
Control means are provided for controlling liquid . ~lows through the injector means, conduit ~eans, blood cell .
receiving means and enclosure means. The control means allow 1~ ~or the flowing ol suspended blood cells into each o~ the blood cell re^eiving means, Por the ~lowlng of a wash liquid through ea^h o~ the said conduit means and then through the compacted blood cells in each o~ the blood~cell reaeiving means, ~or the ~lowing o~ a recuspend~g liquid ~nto the . 20 ~ enclo~ure means and into the blood cell receiving means and ~or the ~lowing of resuspended blood cells from each of the rec~vlng means through each, respective, conduit means, through the injector means and out o~ the c~ tr1~uge apparatus.
The,power means and control means are conventional

2~ apparatus in the art and function in their conventional manners.
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1~)67470 With the ~oregoing arrangement, ~he basic operation of the method and apparatus ~s as ~ollows. Red blood cells in a suspending liquid, such as plasma or artifici~l plasma, are flo~Yed through the in~ector means, then through the conduit means and into the blood cell~receiving~means of the - ~ enclosure~ Since each of the angularly shaped blood c211 receiving means is indspendently connected to the injector by the plurality of respective conduit means, a plurality ~; o~ recelving means can be simultaneously filled with~suspended blood cells~ Thus, the oentrifuge apparatus can be loaded with the blood uhile the centrifuge is rotating. Indeed~
the rotation of the enclosure means (with the plurality of blood cell recei~ting means) helps to distribute the blood essentially evenly within the plurality of recei~ing means.
A~ter su~icient centrlfugal force ~s generated on the sus-; pended blood cells, the heavier~solid particulate bl~od ~
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~ ~ cel~s will be forced~toward the locus o~ maximum~centrilugal ; .
force and compacted in that region. The suspending liquid, on the other hand, will be displaced from the locus of maximum centrifugal force and toward the axis o~ rotation ~ -.. .
of the enclosure means. After that separ~ion has bee~n ~, accomplished by sufficient centrifugal force, then the .
blood cells can be washed by flowing a wash liquid through each o~ the said conduit means~and then through the blood~
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2~ cells in each of the blood cell receiving means. Here again, ~12-, .

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--``` 1067~70 the wash liquid is displaced ~rom the locus of maximum centri-- fugal forcè towards the axis of rotation of the enclosure `' means. Thereaft'er, the blood cells are resuspended in a liquid and removed from the apparatus. Of course, as - 5 described above, the injector means is at the axis of rotation and is provided with means for moving the wash liquid and re-suspending liquid from the enclosure means and to the outside~
of the centrifuge apparatus.
~ , . As another important feature of~the invention~, after the washing has taken p~ace as described above,~ the washed~
blood cells can be removed from the blood cell receiving means ~ . .
through each of the respective conduit means and subsequently ' ' through the inJector means and out of the centrifuge apparatus, ~- while the centrifuge apparatus is being rotated. This may be 15~ ; accomplished,;among o~ther ways~s;imply by~flowing a liquid through the injector means and through the enclosure means which thereby forces the~compac'ted and washed blood cells from the receiving means,~ through 'the conduit means~and ou~t of the centrifuge apparatus via the injector means. Of course, when ~' 20 ehe blood cells are so "u~loaded", the rotational speed of the centrifuge is considerably reduced, e.g. below 400 RPM. This ~. . .: ~
' counter flow of liquid is accomplished simply by placing a greater pressure head on;the counter flowing liquid than the pressure developed by the lower rpm's of the centrifugè during that "unloading'l step. A pressure differential exerted by the resuspending liquid acr~ss the compacted blood cells of at least about 1/4 pound will normally be used.

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From the ~oregoing, ~t can be seen that the centr~-` ~uge can be contlnuously operated in that blood`cells, suspended - in natural plasma or artificial plasma, can be "loaded'l into the centri~uge, separated by centrifugal rorce, washed~ and , 5 "unloaded" from the centrifuge without the cen~ri~uge ever :
beillg com~letel~ stopped. Only the di~erence in rotational speeds are required for the steps. This ls possible s~nce . the washing step ~ully cleanses the in~ector means, oonduit means and blood cell receiving means prior to the "unloading"
~ step, so that the cleaned blood cells flow onIy throagh this -.~ - previously cleaned path.
- It should be ~urther appreclated that ~ince ths washing li~uid enters the receiving means, ~from the conduit ~- means, at the point o~ maximum ;centrifugal ~orce, the washing liquid passes through essentially all of the compacted blood-cells, which is not the case w1th prior art arrangemen~s~
: . as discussed hereinbefore. As in those arrangements, the.
washing liquid could never be intrnduced .into the~locus o~
.~ maximum centrl~ugal ~orce and some amount o~ blood cells could ~O ne~er be fully ~ashed by the washing liquid. Thus, a~hazard of residual contamination was always present whioh caused concern ~or the "purity" o~ the washed blood ~nd required a : cleansing of the apparatus between batches.;
Further, with the present arrangement, the number .of blood cell recei~ing means may signi~ican~lg exceed the .
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two containers used in the prior art, as disclosed above~
Indeed, a pre~erred form of the in~ention uses elght separate blood cell receiving means and thereby ~reatly increases the efficiency of ths present arrangement over the arrange-ments of the prior art.
~lso, by reason of the present arr~ngement, as discussed above, a disposable enclosure means with the blood cell receiving means can be provided and that arrangement - allows ~or rapid removal o~ the disposable enclosure means2 ~ 10 Thus, the enclosure means may be constructed of any inert ; ; material which can be releasably held by the rotation means of the centrifu~e. In this regard, the rotation means will have at least one cavity therein for receivin~ and retaining enclosure means during rotation thereo~. This will, of ... . .. .
course, require that the cavity of the rotation means and the . . : ~
enclosure means have~complementary shapes so that the enclosure means may be periodically removed ~rom the ca~ity of the rotation means and replaced by a new~enclosure means.
~; Of course~ with such an arrangement, it is most convenient ; 20 that the enclosure means, the conduit means~ the in~ector means and the sealing means ~orm a replaceable and disposable unitary structure. In view of the intended disposable nature - thereo~ the so produced unitary structure is preRerably made, ;- - pr~ncipally, of a moldable material, and especially an extendablé ~aterial so that small differen e~ in the '. ' ~ ' .

~067470 complementary shapes of the disposable receiving means and the cavity in the rotating ~eans can be compensated for by extenslon o~ the enclosure means. In~ other words~ the shape of the unitar~ structure can there~ore be con~ormed to the shape o~ the cavity in the rotation means by action of entri~ugal forces on the unitary structure during ~he .rotation thereof.
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Other important ~ea~ures o~ the invention and advantages of the invention over the prior art will be apparent 10 ~ from the ~ollowing detailed description of the invention.
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BRIEF DESCRIPTIO_ OF ~E DRA'~I21GS
: ~igure 1 is a perspective exploded view showlng : an embodiment o~ the invention, particularly with reference : to the principles involvea. ~
. Figure~2~is a~perspective view of the rotat~ng , ~ .
seal used ln the assembly o~ Figure 1. .
Figure 3 is a perspective view o~ the i~e^tor means used in the assembly o~ Flgure~
. Figure.4 is a broken cross-se~tional view o~ a ~:: 20 portion of the assembly of Figure 1, and Figure 4 further illustrates the princlples o~ the invention.
igure 5 is an exploded cross-secti~nal vlew of a preferred form o~ the inventlon wherei~ the;enclosure means i8 disposable.
2~ Figure 6 is a top Yiew of the~ disposable enclosure means o~ Figure 5.

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- Flgure 7 is a bottom view o~ the disposable ; enclosure means o~ Figure 5. ~: ~
F~gure 8 is an exploded view of the disposable ; enclosure means o~ Figure 5.
Figure 9 is a partly sectioned and exploded vLew o~ tke seal and:~ilms:making up the disposa~le enclosure ~: means o~ ~igure 5.:
~: And Figure 10 is a partly broken and cross-sectional ew of the in~ector means used wLth the disposa~le enclosure ~ means o~ Figure 5.:

DETAILED DESCRIPTION OF THE INV~NTTON ~ ;

. The invention can best be understood by specific .
re~erence to Figure 1 where the principles of~the invention are illustrated in terms o~a epeciPic ass~embly. The assembly~
~of that embodiment~i6 co~posed of~four~main~as6embly~plates~
Bot~om plate 1 of the assembly has a plurality:~o~ recesses:~
2 in the top surface 3 of~the plate. At the periphery~4~o~ :
.bot~tom plate 1,~ the recesse6 2 terminate in registry with openings 5 traversing through intermediate;plate 6. When i~ter-mediate plake 6 is secured to bottom plate l, the co~inat~on !,~ 0~ plate 6 and recesse6 2 will.thereby ~orm enclosed recessed :~ conduits 2 leading ~rom the openings 7 in:rotating seal 8 (See ~ ~Figure 2) to the periphery o~ bottom plate 1~
. -: Ope~in~s 5 in ~ntermediate plate 6~are in registry with the apex 9 o~ each respective blood cell recelv-in6:means, . ~ , . :
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~ .generall~ 10, of receiving plate 11. tJhen.top plate 12 is : secured to recei~ing plate 11~ in combination with those two plates being secured to in~ermediate plate 6 and bottom plate 1, then blood c~ll receiving means 10 becomes part of an - overall en~losed space de~ined by receiving plate lI, inter- `~
mediate plate 6 and top plate 12, and especially the ~all ... portions 13 of receiving plate 11.
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` The various plates, described a`Dove, can be att ched `~ by any suitable device, such as bolts 14 or the like. Rota.ting seal 8 tSee ~igure 2) is disposed in and engaged in a liquid-: tight manner by the respective apertures 15, 16, and 17 in plates 1, 69 and 12. Openings 7 in rotating seal 8 are at .- a level and position corresponding to the level and position .
'~ ~L conduits 2 in bottom plate 1, while openings 19 in rotating ~ . seal 8 correspond to tne; level and position, generally, of .
`~. . the center o~ the apexes 9 in receiving plate 11. : ~ .
~ n injector 20 (See ~igure 3) is dlsposed within ; rotating se&l 8 .~See Figures 3 and 43 to provide pathways for;. i~quid ~low into and out o~ seal 8 at levels corresponding to the openings 7 and l9o Accord~ngly, liquid flow path~ays are established in the assembly from openings 21 in the injector 20~ thLrough the lo~Jer openings 7 o~ the rotating æeal 8, through conduit~ 2, through openings 5 in intermediate plate 6, into the receiving means 10 of receiving plate 11, through the enclosure defined by plates 6, 11 and 12, through u~per openings 19 of rota.ting seal.8 and out o~ in~ector 20 via openings 22.

; : ~ . . :' .- i S~nce ~he assembly will be ~ ted at relatively , high angular speeds, it is necessary that the assem~ly ` be rather rlgid and for this purpose a plurallty o~ bolt holes 23 may receive a plurality o~ b~jlts 14 ~or threaded , ~ engagement into threaded holes 24 of Oottom plate l. ~Addi-~'r tional rlg~dity may be provided by Sti~fening~annular rings ; 25 which correspond to openings 26 in bottom plate 1 and ~; ~ openin~s 27:in top plate 12 and are secured to the assembly ~` ~: : by means of appropriate bolts~28 which pass through the '~ lo assembly and~are secured by nuts (not'shown) on~the underside o~ bottom plate l. Rings 25 may be sealed against liquid 1OW out of top p-ate 12 or i~to the recesses o~ bottom plate 1 by "0" rlngs disposed ~. "0" ring recei~ring recesses at the top and bottom o~ rings 25 (not shown), '~,desired.
' 15 The principles,o~operation of the:assembly of ~;: 'Flgures 1 through 3~ and particularly as pertains *o Figure ~:
can bette:r be understood by referencé:to Figure 4. ~In Figure 4, bottom plate 1 has recessed conduits 2 therein, which :~ ; .conduits are enclosed at their upper portions by inter-: 20 mediate plate 6. Th~ openings in intermediate plate 6~at 5 ' terminate at each apex 9 o~ con~erging walls 13. A fluid ~:'. pat~way, as described above~ is provided through open~ng 7 : o~ rotating seal 8> through conduit 2, through opening 5, . through the enclosure generally designated as:40, out ~hrough . :
. 25 opening 19 of seal 8 and out o~ the appara~us through pipe 41 . of ~n~'éctor 20.

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~ '' ' ' ' : ' O~.i7470 l~hen the assembly is in rotation, at operational rpms, su~icient centrifugal rorce develops so that the aolid particulate matter in the centri~uge collects in the receiving means, generally 10, bounded by converging walls 13. In this ` 5 case, the blood cells are shown compacted in the receiving means 10 o~ the broken ~way por~ion shown in Figure 4. :The :
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The compacted blood cells displace the plasma ~
. associated therewith towards the openlngs l9 of seal 8.: When ~.... 10 the separation o~ the blood cells has been sufficiently accom- -plished, a wash liquid can be introduced into in~ector 20.via pipe 42 and passes through openings 7 and conduits 2 as shown .
` ~ ~ by the arrows. The wash li~uid then passes throagh openings 5 and spre2ds out to wash the blood cells ~3 compacted~in rece~ing means 10. The wash Iiquid, therea~ter, by virtue o~
a higher pressure head, passes through enclosure 40, out of ;
openings 19 of seal 8, through in~ector 20 and out of the : apparatus via pip~ 41. : .
It will be appreciated that the blood cells 43 are :~ 20 o~ greater density than either the plasma normally associated therewith or the wash liquid which is subsequently used for , . :
washing the separated blood cells. Under the circums~ances, . ~ the centri~ugal ~orc~e acting upon the blood cells~will be greater than the centrifugal ~orce ~cting upon either the - 2~ plasma or wash liquid. Therefore3-both the plasma and wash : , .
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~0~7470 liquid can be passed through the blood cells, by.means o~ an increased pressure head above the centri~ugal force on the blood cells, since the more dense blood cells will cause displacement of the plasma or the wash ~.iquid tot~ard seal 8, . 5 the axis o~ rotation o~ the en210sure means~ whe~ the ~ssembly is at op.rational rotational speeds.
It can also be appreciated ~rom the assembly of Figure 1 and the explanation thereof of Figure 4 that with the present arrangement, the wash liquid is introduced at the apex formed at the juncture o~ the pair of oppositely ~; disposed con~erging wall portions of the blood cell receiving means. With this arrangement, as opposed to prior art arrange-~
ments, the wash liquid w~ll contact substantLally all o~ the compacted blood celis. In prior arrangements, the wash 15 . liquid could only be intrsduced "close" to the locus of ~. -~:-maximum centri~ugal ~orce, but those arrangements~were not capable of introducing the wash liquid ~ust at the l~cus ~of maximum centr~fugal force~ This was because the conduits wsre internal o~ the bag sr container for enclosing the blood cells and the csnduits could, ~here~ore~ not terminate at the .
.. po~nt of maximum centri~ugal ~orce, ~ince they would therefore ; be totally closed of~.
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~: With the arrangement sf Flgure 1, however, other ~mportant advantages can be easily understood. Thus, the ~ 25 plurality of b~oo~ cell receiving means.provides mu~h grea.ter .
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e~iciency than ~hose of tne prior art where only, generally9 two difPerent blood cell receivin8 compart~ents or bags were provided. Further~ the plur~lity o~ independent conduit means o~ the present arrangement are cleaned durin~ the washing process and the washed blood can be resuspended and passed back through those washed conduits~ in a counter-~low direction, without contamination o~ the washed blood. Also, no independent ~low path ~ro~ the ~espective receiving~means ;
.
need be provided for~removing tha plasma and ~sh li~uid ~rom~
the enclosure means. Thus the enclosure means, essentlally, ` is open to all of the receiving means and presents a more - e~ficient use of path~ays ~or removing plasma and wash liquid during operation of the centrlfuge.
It will also be noted tnat while the arrangeme~t 15 ~ has a pair o~ opposite wall~portlons which converge, intermediate plate 6 and top plate 12 are parallsl and the wall portionso~ the blood rell rec~ving means ~ormed by those plates do not converge. Particularly for the two fore-going reasons, a pre~erred embodlment of the inventlon 1B
shown in Figure 5. The arran~ement of Figure 5 di~fers from the arrangement in F1gure l, principally, ln the~paTticular shape of the enclosure means, the ~orm of the rotational means and ths speci~ic shape o~ the blood cell re~ceiving means.
Also, the enclosure o~ Figure 5 is disposable~ but it should be appreciated that a disposable enclosure in the basic configu-~ation of Figure 1 ma~J be used. Otherwise, the '' ` ' ~2 .
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, - general ~low paths and operational ~haracteristio6 o~ the preferred arrangement of Figure 5 are ~imilar to those of Figure 1, particularly as explained in ~igure 4.
In ~igure 5 there is shown a disposable enclosure means, generally 50, consisting o~ a blood cell receiving means, generally at 51, and an integral seal ~Rans, generally ,-: ; . :
at 52. The disposable structure has independent conduit means 53~ which corresponds to the conduit means 2 of Figure - 1. m e roiational means is comprised of a lower platen member54 and an upper platen member 55 havlng a hardened but replace-` :~, able and c~astable material 56 disposed therein, e.g., cement, plaster, polyester, or epoxy reinforced plastic and the like.
The shape o~ the castable material conforms generally to the - shape or con~iguration of the; disposabl~ e~closure~means 5Q
the upper portion thereof). ~ a~ ~course, the orlentatlon of platens 54 and 55~and disposable enclosure 50 can ~e reversed, , i.e., castable mate:rial 56 can be in bottom platen 54 and the ;- outside orientation of disposable enclosure means 50 is ~; reversed. Since the d~sposable enclosure means 50 carries its ~n ~ntegral seal 52, no permanent seal, corresponding .~ . , to seal 8 o~ Figure 1~ is needed in this embodlment. An inJector means 57 ~shown in a brogen view) corresponds to the injector means 20 of ~igures 1, 3, and 4, but is also disposable~ The operation of the injector means ls the same as described therein, although the speci~ic spaciæl arrangement ~" . , ' . ' ~ ' . .

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` ~L067470 `
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, o~ the pipes are somewhat di~erent to acco~modate the tntegral seal 52 o~ disposable enclosure 50, as shown in - Figure 5. Lower plæten member 54 has a plurality o~
upstanding indexing pro~ections 58 which correspond to ~-.` 5 indexing holes 59 in disposable enclosure 50. These simply ` index the dispos~ble enclosure correctly within the cavity ~`. formed between~lower platen member 5~ and upper platen.member k.~
55 when the two platen members are secured together. Lower platen member.54 has~a rotor base 60 whlch~is attached by any convenient means such as splines and the llke 61 to a .~.` drive sha~t 62 an~ power means 62~a), e.g., an electric motor.
. Seal me~ns 52 is held ~n recess:63 of lower platen member 54 b~
:. means o~ seal projection 64. Seal projection 64 also forms .
a support ~or in~ector~means 57. ~~ ~
With particular reference to ~igure 6~ whlch 1s a I~ top view o~ the disposable enclosure and seal:means,~Lt ~rlll e.'.~ be seen that the blood cell recelving means,~gener~lly 515 has oppositely dlsposed converglng wall portlons 65 and 6O, 1n a ~ manner similar to that of Flgure 1. However* additionally, the 20 top and bottom wall portions~67 and 68.(see ~igure 5) also . rOrm an angle, i.e., converge. Further,.as shown in Figure 6, wall portions 69 and T converge from pinnacle 71. Thus, . there are multiple pairs o~ opposite wall portions which c~nverge toward a locus o~ ~aximum centri~ugal ~orce, in the arrange~ent o~ Figure 5, and this e~fects a multiplicat~on :

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lO~t7470 o~ the e~f~ciency of the c~nt~lfugal ~;orce:exerted on the blood cells with~n the blood _ell re^eiving means 51. This, of course, is a ver~ ~dv~n~eo~s ~ature o~ the present invention.
The flo~.l path~ e arr~ngement~of Figure 5 are ~`~ quite simila~ to he flow paths descr~bod~in detail in connection Wit~ Figur~s 1 and 4~ -Thus,~the blood is pu~ped . . . ~ ~ .
through pipe 72 (via control means 72a) o~ in~ector 57 and :through a ~ultiplicity of ports 73 in~seal 52 into the : :
respective conduits 53 formed between mèmbers 58 and:74. The .
condults terminate at openings 75 at the locus of mæximum centrifugal force. The openings 75 communicate conduits 53 with the blood cell receiving means, generally 51. The . ~ enclosure then provides a pathway to discharge~ports~76 ~hic'n comm~nicate through seal 52 to injector 57 ~or passageway through the in~ector and out of discharge pipe 77 ~vLa control means 77a), .. The disposable enclosure 50 is there~ore replace- .
able within the cavity formed by lower platen member 54 and upper platen member 55, simply by removing injec~o~ 57 and separating upper platen member 55 ~rom lower platen member 54.
The disposable enclosure 50 and seal 52, then li~t o~f~o~
~: lower platen member 54 and can be di~carded~ The disposable enclosure and seal are a unitary structure consisting of the blood cell receiving means 51, the enclosure means, generally 50~ the seal means 52 and the conduit means 53, Since in~ector - 57 is also disposableg ~o Gleaning of the centri~uge is required~ in the manner of Figure 1, ' ~

106~470 The convenience of the arran~ement shown in Fl~ure .
5 is most apparent and the disposable enclosure o~ the arrange-ment forms a ~ery important feature of the invention. That enclo~ure~ in a pre~erred embodiment~ 1s made ~ith three separate films (or members) of an inert material~ e.g~, plas-tics and the like. The first ~ilm or member 74 forms the - bottom portions o~ conduits 53~ while the second ~ilm or .
member 68 fcrms the~top portions o~ conduits 53. The second ~ -~ilm 6a also forms the bottom wall~of enclosure 50. ~The third or top most film or member 78 comp1etes the~three films ; or members forming the disposable enclosure. Parallel but displaced l1quid-tight ~eals 80 and 81, e.g., he~t seals, bet~reen ~ilms 74 and 68 (See Figure 7) ~orm oonduits 53 which terminate at openings 75. The shape o~ top ~ilm or member 78 : . .
is normall~ accomplished by molding operation~ such as a vacuum thermo-forming operation, in manners~well kno~n to the art.
The arrangement and construction o~ the disposable ; enclosure can better be understood by re~erence t~ Figure 8.
.
In this embodiment, thermoplastic f~lms are used for ~
constructing the disposable enclosure. Thus, lower film 74 has placed on top thereof intermediate film 68~ Th ~ ~
i~termediate ~lm has a plurality o~ holes 75 pun~hed therein and heat seals 80 and 81 ~orm conduits 53 which terminate at holes 75. Upper ~ilm 78~has thermo~ormed thereinto con-verging wall portions 67, 69 and~70, which converge 1rom apex : ~.. '- ..
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10~747(:~
71 to~ard t}le periphery 90 of upper film 7~. These wall por-tions converge at 91 to ~orm a~locus o~ maximum centri~u~al force~ w~en ~he disposæble unit is rotated ~lithin the arrange-ment o~ Figure 5. The peripher~ 90 is sealed (e.g~, heat sealed) along the outer portion 92 o~ film 78 to ~orm a .
", unitar~ structure, in the manner illustrate~'in,Figure 5.' -The seal means which completes the ~nitary dispos-æble structure is shown par~ly in cross-section and in exploded ~ .
, view in Figure 9. The seal comprises base plate 100 having outer pro~ections 101 around the periphery thereo~. Inter- ~
mediate plate 102 is con~igured such that its outer periphery 103 con~orms to the outer periphery 104 o~ base plate 100.
The in~er periphery 105 ol intermediate plate 102 is con-figured in a diameter equal to interior pro3ections 106 o~
- 15 base~plate 100. Similærly, outer projections 101 are so~
.
positioned àround the periphery of base plate lOQ so as to ,' contac~ the undersurface of intermed~ate plate 102 near the outer perlphery 103 thereof. This arrangement bet~Teen base plate 100 ænd intermediate plate 102 provides a chamber between base plate 100 and intermediate plate 102 with a .
multiplicity o~ ~low ports 73, for appropriate ~low of liquid into conduits 53 and then lnto blood cell receiving ' means 51, ' :
A similar arrangement is provided ~or an exit ~low path. Thus, top plate 108 has similarly arranged top : . .. .

' - -27-. . ` .

` `` ( 1067~70 p~ate intermediate and outer pro~ections 109 and 110, respecti~ely, which cooperate w~th the~top co~er plate 111 to produce ~low ports 76, ~or appropriate ~low o~ ~luid ~rom the blood cell recei~ing means 51 (See Figure 5).
. 5 As noted abo~r~, the seal, enclosure, and conduit~
form a uni~ary structure which is disposable. The enclosure ;- and conduits are made, as discussed above, b~ heat sPals and :~ thermoforming of the films 74, 6~ and 78. The enclosure and . ~ . , , , ~
~ æeal are then assembled as a unitary structure.by appropriate ~ "f ' ' : ' placement o~ base plate 100, intermediate plate 102, top plate 108 and top cover plate 111 between ~iLms 7~, 68,:and 78. Thus, the undersurface 112 of base plate 100 fits over ; the innermos~ peripheral edge of ~ilm 74 in the area generally at 113 of Figure 9. Intermediate plate,102 then is assem-.
~; 15: bled onto ba.se plate lOO, in~the manner describ~ed above,: and toward the outer periphery 103~:o~ intermediate~plate~102, generally at~114, fllm 68 1s placed such tha~ the underside : : : - : of the film, generælly 115~o~ Figure;9, o~erlays the outer ~ : ~ periphery:114 ol intermediate plate 102. Thus~ the conduits: ~ O are in commun~cation with the ports 73 o~ the sealing:de~rice.
:
Film 68 is then held in place and clamped between inter~edlate . , plate 102 and top plate 108. Top cover plate lll is then assembled onto top plate 108. The underside o~ the inner-periphery.of ~ilm 78, genærally;at 116, o~ Figure 9, is placed ~ 25 over the outer periphery, generally at 117, of the top cover :~ . plate 111 of ~igure 9.

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-~. The assembly of the conduits, enclosure and seal is then ~ormed into a unitary structure by.causing base~plate 100, intermediate plate 1O2J top plate 108, t.op co.-~er plate 111 and ~ilms 74, 68~ and 78 ~o be f.nterlocked, as by adhesion~
5 . ~ into a single unitary structure. The interlocking can be.by~
any desired meansJ such as gluing with an adheslve, heat or . - :solvent sealing or other adhesion or fusion. .~.Alterna~ely~
~: . frictional engagement and the 11ke may~be used.~ It~i~s pre-~:.............. ferred, however, that the integral and~.unit~ary structure be interlocked by at least an~adhesive or~heat seal between the interlocking elements, as~described above. OI~ course, the particular method and.arrangement o~ a sembling the unitary structure of the disposable enclosure ~Jith.the seal is not a~ all critical: and may be:practiced as desire~d:. The ~ore~
~ ~ 15 ~ going simply;~llustrated a suita~le method for manu~acturing ,'f O ~ the unitary structure. The ~ilms are pre~erably~made of a polymeri~ materisl,~e.e., of plastic resins~ such as~s poly-~ ole~in ~polyethylsne,~polypropylene, poIypentene), polyv~nyl :~ ~ chloride, polyvinylidene chloride, polyv~nyl acetate, ~
20. : polysty~ene~ polyacrylate (such as polymethyl methacrylate), polyester, po~lysmide ~such ss nylon 6 or nylon 66) a polysl-loxsne,~polycarbonate~ polyacetate or butyra~e, natural or synthetic rubbers snd:combinations thereof. Simllsrly, ~ ~ the seal elements may be made o, such polymeric~materials.
: 25 Pre~erably~ the rilms and seal elements ~re msde o~ a thermo-: . .
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~' .' ~ '' ~ - :
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, ' `1~67470 plastic polymeric material, although this is no-t required.
Any o~ the ~oregoing polymers can be used in producing the ~- seal elements, but relatively low ~riction polymers are~preferred, . especially polyamides and polyolefine~. Additionally, at } 5 least the inner-periphery of the seal can~be made o~ orcoated with a polytetra M uoroethylene resin to ~urther reduce friction between the seal and the in~ector, since~
; the seal must spln in a liquid-t1ght engagement with the injector. ~ ~
. 10 ~he injector is ;shot~n in Figure 5 and:it will be seen that there is a liquid-tight but slidable~engagement between the inner periphery of seal 52 and the outer sur~ace .. . . : , of the injector 57. The injector may be simply in cylindrlcal orm as ahown in Figure~lO. In~that~àrrangementj injeCtor 57 has an entry pipe 72 ~or conveying blood and/or~wash liquid into~the~ lower portion 120 o~ the~injeotor 57 via opening 121 in divider plate 122~ ~The;fluld passee~out o~ the ln~ector via entry ports 123 and~into~the seal, as shown in Figure 5, ~o pass through the seal by way o~ entry ports 73 lnto co~duit 53. The wash liquid, w~h has been passed throug~ the com-pacted blood cells~ passsd through the enclosure generally at 50,~in~o discharge ports 76 o~ the seal and into dis-oharge ports 124 o~in~ector 57 (see Figure 10). The wash uid is then passed out o~ the in~ector and apparatus via . 25 exit pipe 77. A holder 125 may be fixedly attached to the injector for scre~Jed engagement, or the lLke, via internal thread~ 126 for support of the in~ector in sny desired msans.
Alternate supports for the injector may~be provided, as deslred.

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~067~7 .` , ~ , , The injector may be made o~ any desired material, but one 0 the above nct~d polymers is preferred. The surface o~ ~h~
injector can he reduced in friction by application o~ a lubricant, such as silicone grease~ or a polytetrafluoro- ;
ethylene dispersion or the like. Additionally~ if desired ~` a sealing ring 1~8 ma~ be retained in a corresponding recess on the outer surfaee o~ the 1n~ector for sealin~ the ~n~ector agatnst top cover plate lll of the seal, generally at 130, as shown in ~igure 9. AlternateIy, or in addit~on the~reto, top cover plate 111 may have its o-.nn sealing ring or seal~ng ~
portion 131 made thereinto. A similar sealing rln~ or por~ion 132 may be ln top plate 108 to seal the respectlve chambers whlch open lnto ports 73 and 76~ The seallng rings or seallng portions can be of any desired relatively low ~riction ^ ~ 15 material, such as molded polytetrafluoroethylene, nylon and the 11ke. Agaln, blologlcally ~nert greases such ~s slllcone grease or petroleum ~elly may be used as a lubri-cant ~or these sealing rings or portions. Also, such a :, ~
lubricant can be placed on the portion of base plate 100 t~hich will normally contact the base of the in~ector-57, to - , reduce the sliding friction therebetween.
While not sho~Jn in the drawings, the centrifuge apparatus will also have associated therewith reservoirs, pumps and receiving containers ~or ~lowing blood, wash water and the like into and receiving washed blood out of the appar-; atu:. Of course, the apparatus will also have associated .~!

` ~ ~067~70 therewith ~ po~.~rer means and driving mechanism, sueh as motors, .
speed controllers and the like, for rotat`ing the rotation means and enclosure mean3 with su~ficient angular rotation to separate the blood cells from the suspending liquid (p~asma) and so~pa~t the blood cells in the rece~ving means.
Also provided are control means controlling tne rotatlon of the centrifuge and the ~lo-~o~ the various liquids, as des^ribed ~,t aboye For example, liquid flow control must be provided in conjunction with entry pipe 72 by control means 72a~ ~in~a~
manner known to the art so that blood may be ~lowed into pipe 72 and therea~ter wash liquid flowed into pipe 7?.
Sim~larly, out o~ disehsrge pipe 77 via contro~l means 77a ~s passed wash liquid during the washing step~ and blood cell resuspending l1quid i9 flowed through pipe 7r (via control~
means 77a) and into the en^losure, for resuspending ~he;blood ; cells and ~flowing the resuspended blood cells back out o~
the appar~tus via conduit 53 and entry p~pe 72. These assoeiated~devices, power sources and controllers are , . : . . ~
known to the art and need not be described herein. In thfs regard, reference is made part1cular1y to the U.S. patents ~nd publications mentioned hereinbefore.
In oper~tion, the apparatus is provided with reservoirs o~ blood and washing liqu~d which can be ~e~uen-: tially dire~ted into entry pipe 72, by appropriate and conventional ~low control means 72a. A pump~ biologically :
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accep~a~le~ forces blood fro~ the reservoir into :pipe 72, out of entry ports 73, through conduit 53 and~into enclosure 50~ The flow of the blood from the blood supply, o~ course, goes through each of the plurality o~ independent condu~ts into the enclosure. In this rega~rd, the~enclosure~ as de-fined above, has a plurality of an~ularly shaped Olood cells ;~ ~ receiving compartments. These co~partments~are evenly~paced, as defined herein~efore, about the }on~itudinal periphery of the enclosure. Also as discussed above, at least one pair of ! ' : . ' , opposite wall portions of each of the compartments converge ~` toward the longitudinal periphery of the enclosure. Like-wise, as ~iscussed above, the first ends of the conduits are in co~munication with the blood supply and the other end of the conduits are connected with the apexes o~ the con-verging wall port~on of each of the blood cell `receiving ~compartments.
The enclosure, held in the cavi~y of the centrifuge, .
: 18 rotated at a first lowèr angular speed about its transverse àxls to help in evenly distrLbuting the blood within the enclosure. m~s can be a relatively low angular- s~eed, and indeed can be practlced si~ply in bringing the centri~uge up to operational rotational speeds for separating the blood cells, as discussed below In any event, after the rotation of the enclosure has commenced, the speed of angular rotation is increased until there is sufficient centrifugal force , ~33-::
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~ ~067g~70 exerted on the blood whereby the blood cells, especially the red blood cellsj are separated ~rom the 11quid portion of the blood (the plasma) and the red blood cells are compacted and relatively evenly distributed ln ~he recelvlng compartments.
Qnce this separation of blood cells~has been accom-plished~ a wash liquid is t~en ~owed ~rom a~convenient wash liquid supp-y source, which is in communication with the ~irst ends of the conduits, through the conduits, into the apexes of the converging wall portions of the compartments, through the compacted blood cells and through the enclosure. Of : .:
course, the wash lLquLd finally exits from the centrLfu~e through discharge~pipe 77. This ~low o~ wash liquid is con-tinued untll the red blood cells are washed substantially : ~ree of con~aminants, as discussed above. It should ~lso be ;~ 15 ~noted that~the washing liquid will similarly wash the~en-closure, seal and~discharge~pLpe 77~at that same ti~e. ~
Thereafter, the angular ~peed o~ rotation~of the enclosure is reduced so that the compact blood cells ln the reoe~ving compartments ma~ be resuspended in~ suLtable resus-~- 20 pending liquLd. The resuspending llquid for th~ b~ood cells is flowed into the enclosure by way o~ discharge pipe 77, ~ ~- through the seal, and reeuspends the blood ceils in the~
;~ suepending liquid. The ~low of the resuspended blood cells continues through opening 75 at the apex of the converging ~ :. , . : .
~ ~ 2~ wall portions~ through the conduit 53 and into a suitable . ~ .
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` ~067~70 collecting reservoir via the seal and entry plpe 72. I~
desired, the resuspended blood cells can be sucked ~rom the receiving means by vacuum; since ~he ~lexible, plastic converging walls cæn collapse under the vacuum reduced ~essure.
~ 5 . . Thus, it will be appreciated that ~he washed blood ;. cells are passed countercurrently back through the apparatus a~d in the pàthway whi^h has been fully washed by the wash liquid in washing the red blood cells.~ This avoids any `~ chance of contamination of the washed blood a~d is an . 10 importan~ ~eature o~ the method and apparatus o~t~e Invent~on.
Additiona1ly, it should be ~ully understood that the washin~
w~th the wash liquid commences as the wash liquid enters the compartment through open~ng 75. This opening is at the point .. . . .
~ . o~ maximum centrifugal force and will therefore contact all . .
:~ 15 parts of the compacted blood cells~ as opposed to prior art methods and apparatus.
- The particular angular speeds o~ rotation can vary considerably depending upon the specific diameters~of the ,~: enclosure and compartments. Obviously, for larger dla~.eter enclosures, sufficient centrifugal force w~ll be developed at much lo~er angular speeds than will be required for . smaller diameter enclosures. However, as an indication of appropriate speeds, suff:icient centrifugal force will be developed in a 12-inch diameter enclosure when the angular 25 speed or between about 1500 and 5,000 revolutions per minute, .' . . .
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~067470 more o~ten between 2,000 and 4,000 revolutions per minute, e.g., around 3~000 revolutions per mlnuteO The temperature at which the process is carried out is not critical and may , . .
be carried out at an~ temperature above the ~reezing~point or ~oagulation point of the blo~d and below the denatu~ing : point of the blood. Gene~ally, temperatures between about ~ .
40F and 120F are satislactory, especially between a~out . 60~P and 90~F. The process is operated under pressures generated by the centrifugal force and in combinztion with the head pressure exerted by the ~ash fluid during the washing step or by the reauspending liquid in resuspending the blood cells and paseing the resuspended cells out o~ the apparatus.
In these latter regards, it is only necessary to supply the wash ~luid or resuspending iluid at head pressures ~or vacuum ~or removing the resuspended~blood cells) great enough to low the wash fluid or the resuspended~blood c~lls opposite - to the centrifugal lorce ~or passing the wash liquid or ~ resuapended blood cells out of the centrifuge. An adjustable pressure pump in thia rega~d is desir~ble so that the pressure ~or causing such ~lows can be readily obtained ~ith di~erent rpms o~ operation.
, ~- As ran also be appre^iated~ tandem arrangements o~
~- the enclosure means may be used i~ desired, either of ~he . disposable or non-disposable arrangements. Thua, for example~
.~ 2~ a stack of two or more enclosure-means~ BS described above, .
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~067470 ` may be ~ontained within a single or ;cooperatlng group of rotation means. Where a group o~ rotation means i8 used, . , .
this requires physical interlo~king of the coopera~ing~
rotation means so that they may be operated by single power means and under the rontrol of a single operator. Otherwise, the operation o~ the enclosure means ~n this tandem arran~e-.
ment will b~ as described above, Alternately, a plurality o~
enclosure means~may~be disposed w1thin a~slngle rotat~lon means. This would only require that the seal me~ns and injection means have mlrror im~ge arrangements ~or receiving an enclosure means in the lowermost part and an enclosure means in the uppermost part of the m~rror image arrangements.
This will allow, ~uite easily, a tandem of two enclosure means.
Yet further, a plurall~y~of enclosure means may be etacked upon ea~h other where the enclosure means are generally ln : : : ~
~- the arrangement of ~igure 1 and a common~in~ector means - passes t~rough the seal means o~ each of thé enclosure means (with the exception o~, of course, the last under en~losure . ,. . ~ .
means). By use of spacers to pos~tion the enclosure means ~, 20 along this common injector means, a single cont~ol~means may be used for performing all o~ the functlons of the plurality o~ enclosure means. ; ~ ~
Other modi~ications ~nd alternatives of the present ;; apparatus and process will be ~urther apparent to those sk~lled ~n the art9 beyond those mentioned above. Thus, the present ~, ~

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spe~ cat~on and claim language are intended to e~brace those above-noted and further alternate embodi~ents as well as other obviouS embodiments. Thus~ the scope of the invention i5 to the extent of the annexed clalms.

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Claims (19)

WHAT IS CLAIMED IS:

1. A disposable structure for use in a centrifuge for the separation and washing of liquid suspended finely-divided particulate material wherein the centrifuge includes means for containing a quantity of liquid suspended material, a rotation means for rotating the suspended material about a longitudinal axis of the rotation means, and control means for flowing the suspended material and a wash liquid into and out of the centrifuge comprising:
(1) a disposable enclosure means for enclosing a quantity of liquid suspended material and adapted and configured to be releasably held by the rotation means in a manner that the enclosure means with liquid suspended material therein may be rotated by the rotation means, said enclosure means having a plurality of angularly shaped material receiving means in fluid communication with each other and evenly spaced about the longitudinal periphery of the enclosure means and forming a part of the enclosure means, said material receiving means having at least one pair of opposite wall portions which converge towards the longitudinal periphery of the enclosure means and thereby form a locus of maximum centrifugal force in the rotating enclosure at the apexes formed by the juncture of the converging wall portions;
(2) a plurality of disposable independent conduit means in fluid communication with each other, each with one end thereof in fluid communication with the said locus of maximum centrifugal force and other end thereof in fluid communication with the control means.

2. The structure of claim 1 wherein the structure also includes a seal means for sealing the enclosure means in a fluid tight relationship to an injector means which is cooperable with the control means for passing suspended material and liquids into and out of the said enclosure means.

3. The structure of claim 2 wherein the enclosure means, conduit means and seal means are all disposable.

4. The structure of claim 3 wherein the enclosure means and seal means form a disposable, unitary structure.

5. The structure of claim 3 wherein the enclosure means, seal means, and conduit means form a disposable, unitary structure.

6. The structure of claim 2 wherein the enclosure means, conduit means, seal means, and injector means are all disposable.

7. The structure of claim 6 wherein the enclosure means, conduit means, seal means and injector means form a disposable, unitary structure.

8. The structure of claim 1 wherein the disposable structure is principally of polymeric material.

9. The structure of claim 8 wherein the structure is composed of a plurality of molded and sealed plastic members which form a unitary structure.

10. The structure of claim 9 wherein the sealing is a heat seal.

11. The structure of claim 9 wherein the plastic is a polyolefin.

12. The structure of claim 8 wherein the polymeric material is a plastic selected from a polyolefin, polyvinyl chloride, polyvinylidene chloride, polyvinyl acetate, polystyrene, polyacrylate, polyester, polyamide, polysilicone, polycarbonate, polyacetate or butyrate, natural or synthetic rubbers and combination thereof.

13. The structure of claim 12 wherein the plastic is extendable.

14. The structure of claim 13 wherein the plastic is sufficiently extendable so that the shape of the structure is closely conformed to the shape of a cavity in the rotation means where the enclosure means is releasably held by action of centrifugal forces acting on the structure during rotation thereof.

15. The structure of claim 1 wherein the suspended material is blood cells.

16. The structure of claim 1 wherein there are from 2 to 100 angularly shaped material receiving means in the enclosed means.

17. The structure of claim 1 wherein the structure is a molded plastics material.

18. The structure of claim 17 wherein the structure is a heat sealed structure.

19. The structure of claim 1 wherein at least the converging walls are made of a flexible plastics material which will collapse under vacuum.