CA1057254A - Disposable centrifugal blood processing system - Google Patents
Disposable centrifugal blood processing systemInfo
- Publication number
- CA1057254A CA1057254A CA258,070A CA258070A CA1057254A CA 1057254 A CA1057254 A CA 1057254A CA 258070 A CA258070 A CA 258070A CA 1057254 A CA1057254 A CA 1057254A
- Authority
- CA
- Canada
- Prior art keywords
- casing
- shell
- centrifugal separator
- disposable
- outer shell
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/02—Blood transfusion apparatus
- A61M1/0209—Multiple bag systems for separating or storing blood components
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
- A61M1/3696—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
- B04B—CENTRIFUGES
- B04B5/00—Other centrifuges
- B04B5/04—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers
- B04B5/0407—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers for liquids contained in receptacles
- B04B5/0428—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers for liquids contained in receptacles with flexible receptacles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
- B04B—CENTRIFUGES
- B04B5/00—Other centrifuges
- B04B5/04—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers
- B04B5/0442—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
- B04B—CENTRIFUGES
- B04B5/00—Other centrifuges
- B04B5/04—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers
- B04B5/0442—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
- B04B2005/0464—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation with hollow or massive core in centrifuge bowl
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Cardiology (AREA)
- Centrifugal Separators (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- External Artificial Organs (AREA)
Abstract
DISPOSABLE CENTRIFUGAL BLOOD PROCESSING SYSTEM
Herbert M. Cullis Abstract of the Disclosure A continuous flow centrifugal processing system for separating whole blood into fractional components in-cludes a centrifugal separator unit having a molded bowl-shaped outer shell dimensioned to fit within a rotatably-driven casing on an associated centrifuge apparatus. A bowl-shaped inner shell disposed within the outer shell forms therewith a-thin separation channel radially spaced from the axis of ro-tation wherein fractions are separated from the whole blood under the influence of centrifugal force. A rotating seal carried on the processing chamber between ports in the chamber and the non-rotating portions of the system. The outer shell includes a relatively thin side wall portion which is inwardly biased toward a side wall portion on the inner shell when seated in the casing. A plurality of projections on the side walls limit inward deformation of the outer shell to maintain a very close concentric spacing between the shell members to facilitate rapid separation of blood flowing through the chamber.
By reason of the shell members being molded, the processing chamber can be economically produced in large quantities for disposable one-time use.
Herbert M. Cullis Abstract of the Disclosure A continuous flow centrifugal processing system for separating whole blood into fractional components in-cludes a centrifugal separator unit having a molded bowl-shaped outer shell dimensioned to fit within a rotatably-driven casing on an associated centrifuge apparatus. A bowl-shaped inner shell disposed within the outer shell forms therewith a-thin separation channel radially spaced from the axis of ro-tation wherein fractions are separated from the whole blood under the influence of centrifugal force. A rotating seal carried on the processing chamber between ports in the chamber and the non-rotating portions of the system. The outer shell includes a relatively thin side wall portion which is inwardly biased toward a side wall portion on the inner shell when seated in the casing. A plurality of projections on the side walls limit inward deformation of the outer shell to maintain a very close concentric spacing between the shell members to facilitate rapid separation of blood flowing through the chamber.
By reason of the shell members being molded, the processing chamber can be economically produced in large quantities for disposable one-time use.
Description
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SPECIFICATION
Backgrou~d of the Invention .
The present invention is directed generally to appar-~` atus for separating or fractionating ~lhole blood into its various individual components, and more particularly to a dis- ;
posable centrifugal blood separator for use in such apparatus.
Intervivos blood processing apparatus, whèrein blood is taken from a live donor, passed through the apparatus, and , then returned to the donor, has come into wide use during re-` 10 cent years. During passage through the apparatus, the blood - may be separated or fractionated into i~s component parts, i.e., plasma, red blood cells, and white blood cells or platelets, ~nd somè portion o~ thQse fractions may be returned to the donor ~` while other portions may be selectively retained within suitable storage means.
.: .
Various types of apparatus have been proposed for the - intervivos processing of blood. One type of apparatus which has come into wide use i9 described in U.S. Patents 3,489,145 and 3,655,123. This apparatus utilizes a centrifugàl separator ~- 20 element in the form of a rotatably driven bowl-shaped outer shell~within which a cylindrically shaped center or filler : ~ ~ piece is suspended to form a na~row sleeve-shaped separation chamber of very precise dimensions. Fluid connections are~es-tablished with the chamber by means of a rotating seal, the chamber having an axially-aligned inlet port at one end for .
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admitting whole blood, and a trio o collection port~ at the other end for removing red blood cells, white blood cells, and plasma components separated during centrifugation. The structure and operation of a rotating seal for conveying whole blood to the chamber and fractionated blood components from the chamber is described in U.S. Patent 3,519,201.
A major drawback of centrifugal processing units of this type has been their high cost of manu~acture. This has rssulted primarily because of the ~ery narrow spacing which must be maintained between the inner wall of the outer shell and the outer wall of the central filler ln order to achieve efficient separation of the blood componen~s during the very limited transit time in which the blood is actually in the pro-~essing chamber. Typically, a spacing o 1.0 to 1.5 mm9 is necessary for typical transit ~imes of approximately three minutes. This dimension must be maintained with a high degree o~ concentricity if mixing of the recovered fraations is to be ~ ;
avoided. As a result, the outer shell has hereto~ore been formed with thick side walls to prevent any variation of the separation ~20 channel width during o~eration of the apparatus. ;
The need for thick side walls has made it heretofore ~ -impractical to mold the inner ~nd outer shells, since the desired thicknesses Gould not be molded with the neoessary precision.
- Instead, such shells have been e~truded and then individually 25 machined, makir.g the cost of mànufacture too high for the ~ ~ ~ ?~
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l~
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SPECIFICATION
Backgrou~d of the Invention .
The present invention is directed generally to appar-~` atus for separating or fractionating ~lhole blood into its various individual components, and more particularly to a dis- ;
posable centrifugal blood separator for use in such apparatus.
Intervivos blood processing apparatus, whèrein blood is taken from a live donor, passed through the apparatus, and , then returned to the donor, has come into wide use during re-` 10 cent years. During passage through the apparatus, the blood - may be separated or fractionated into i~s component parts, i.e., plasma, red blood cells, and white blood cells or platelets, ~nd somè portion o~ thQse fractions may be returned to the donor ~` while other portions may be selectively retained within suitable storage means.
.: .
Various types of apparatus have been proposed for the - intervivos processing of blood. One type of apparatus which has come into wide use i9 described in U.S. Patents 3,489,145 and 3,655,123. This apparatus utilizes a centrifugàl separator ~- 20 element in the form of a rotatably driven bowl-shaped outer shell~within which a cylindrically shaped center or filler : ~ ~ piece is suspended to form a na~row sleeve-shaped separation chamber of very precise dimensions. Fluid connections are~es-tablished with the chamber by means of a rotating seal, the chamber having an axially-aligned inlet port at one end for .
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admitting whole blood, and a trio o collection port~ at the other end for removing red blood cells, white blood cells, and plasma components separated during centrifugation. The structure and operation of a rotating seal for conveying whole blood to the chamber and fractionated blood components from the chamber is described in U.S. Patent 3,519,201.
A major drawback of centrifugal processing units of this type has been their high cost of manu~acture. This has rssulted primarily because of the ~ery narrow spacing which must be maintained between the inner wall of the outer shell and the outer wall of the central filler ln order to achieve efficient separation of the blood componen~s during the very limited transit time in which the blood is actually in the pro-~essing chamber. Typically, a spacing o 1.0 to 1.5 mm9 is necessary for typical transit ~imes of approximately three minutes. This dimension must be maintained with a high degree o~ concentricity if mixing of the recovered fraations is to be ~ ;
avoided. As a result, the outer shell has hereto~ore been formed with thick side walls to prevent any variation of the separation ~20 channel width during o~eration of the apparatus. ;
The need for thick side walls has made it heretofore ~ -impractical to mold the inner ~nd outer shells, since the desired thicknesses Gould not be molded with the neoessary precision.
- Instead, such shells have been e~truded and then individually 25 machined, makir.g the cost of mànufacture too high for the ~ ~ ~ ?~
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57;~5 4 disposable single-use favored for avoiding contaminatlon.
UMM~RY OF T~IE INVENTION_ In one particular aspect the presene inventiGn provides a disposable continuous flow centrifugal separat~r for use in con~uncation with centrifugation apparatus including a rotatably driven casing for separating fractions from a whole Eluid, said separator comprising, in combination: a mold~d outer shell received within said casing in rotatably-locked relation therewith; a molded inner shell disposed within said outer shell in spaced relation thereto, said inner and outer shells including wall portlons forming between their inner surfaces a separation chamber radially spaced from the axis of rotation of the casing, the wall portion of said - outer shell being relatively thin and deformable and resiliently biased toward said inner shell when seated in said casing; means including a plurality of pro;ections on at least one of said inner ; surfaces in abutting engagement with the other of said inner surfaces . .
for establishing a predetermined concentricity between said wall portions; inlet means including an inlet port for supplying whole blood to be processed to said separation chamber; and outlet means including a plurality of collection ports communicating with said separation chamber at respective radial distances from said a~is of rotation for removing respective separated fractions from said chamber.
In another particular aspect the present invention pro- :
vides a disposable continuous-flow centrifugal blood separator for use in conjuncation with centrifugation apparatus including a rotatably-driven bowl-shaped casing for separating ~BC, WBC and plasma fractions from whole blood, said separator comprising, in combination: a molded outer bowl-shaped shell received within said casing in rotatably-coupled relationship thereto; a molded bowl-~
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shaped lnner shell disposed within said outer shell in spaced relationship thereto, said :Lnner and outer shells including generally cylindrical upstanding wall portions forming therebetween a thin sleeve~shaped separation chamber radially-spaced from the axis of rotation of the casing, the wall portion of said outer shell being relatively thin and deformable whereby said shell is deformed toward the wall of said inner shell when seated 'in the casing; means ~ including a plurality of pro~ections on the inside surface of at : least one of said wall members in abuttlng engagement with the inside surface of the other of said wall members for establishing ~:
a predetermined concentricity between said wall portions; inlet means including an inlet port for supplying whole blood to be processed t~ said separation chamber; and outlet means including a plurality of collection ports communicating with said separation chamber at respective radial spacings from said axis of rotation :.
: to remove respective ones of the separated blood fractions from said chamber.
; In a further particular aspect the present invention provides a system for continuous centrifugal processing of whole `` 20 blood into separated fractions comprising, in combination: centri-fugation apparatus including a rotatably driven ciasing having a bowl-shaped recess therein; a molded ou~er shell seated within said recess, and rotatably coupled thereto; a molded inner shell disposed within said outer shell in spaced relationship thereto;
said inner and outer shells including wall portions forming ther.e-: between a separatlon chamber radially spaced from the axis of : rotation of the casing, said wall portion o~ said outer shell being . relatively thin and de~ormable and inwardly biased by said casing;
:pacing means including projections on the inside surface of at lea:st 30 ~ :
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one of said wall portLons in abutting engagement with the inside surface of the other oE said wall portions for establishing a pre-determined concentricity between said wall portions; inlet means including an inlet port for supplying whole blood to be proce~sed to said separation chamber; outlet means including ~ plurality of collection ports communica~ing with said separation chamber at respective radial spacings from said axis of rotation to remove respective separated blood fractions from said chamber; and fluid transfer means for conveying fractions of said whole blood developed at said collection ports to respective storage or utilization means.
BRIEF DESCRIPTION OF T~IE DRAWINGS
The features of the present invention ~hich are believed to to be no~el are set forth with particularity in the appended clalms.
The invention together with the further objects and advantages - thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify like - elements, and in which:
Fig~re 1 is a perspective view of a centrifugal blood separator constructed in accordance with the invention partially broken away to show the internal construction thereof.
Figure 2 is an enlarged cross-sectional view of the blood separator installed in a rotating seal type centrifugation apparatus.
Figure 2a is an enlarged cross-sectional view of the rotating seal assembly utilized in the apparatus shown in Figure 2.
Pigure 3 is an enlarged cross-sectional view of the downline end of the processing channel illustrating the distribution of fractionated components therein.
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Figure 4 is a diagrammatic representation of the flow system utilized in conjunction with the centrifugal blood separator of the invention.
Figure 5 is a cross-sectional view of the centrifugal blood installed within a seal-less centrifugation apparatus.
Description of the Preferred Embodiment Referr~ng to the Figures, and partlcularly to Figure 1, a centrifugal blood separator 10 constructed in accordance ~ith the invention includes a bowl-shaped outer shell 11 dimensioned to fit within a similarly shaped recess in a ro-tatably driven casing (not shown in Figure 1). A bowl-shaped inner shell 12 is disposed within the oute: shell and forms ;
therewith a centrifugal processing chamber 13 within which fractionation of whole blood takes place during rotation of the separator assembly. The rims of the two bowl-shaped shells ~
are joined by cemented tongue-and-groove attachments to a flat ;?
cover member 14 which includes four red blood cell (RBCj ; collection ports LS arranged in a first ring, and four white blood cell (WBC) collection ports 16 arranged at equal inte~vals in a second ring concentric with the first ring but of lesser diameter. The cover member also includes a plurality of aper~
tures 17 at its center for establishing fluid communication ~ith ~ - .
a rotating seai (not shown in Figure 1) in a manner~to be described pxesently. Each of the four collection ports 15 is connected to a length of tubing 18 which extends through an ~' ' , ~,:
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aperture l9 in cover member 14 and into the interior o~ the bowl-shaped inner shell 12. Similarly, each o~ the collection .
ports 16 is connected to a length of tubing 20 which extends .
. through an aperture 21 and into the interior of the inner shell ;
member. :
keerring to Figure 2, wherein the centrifugal . separator unit is shown in conjunction with a rotating-seal type centrifugation apparatus, the outer shell ll o~ the :~ .
separator is seated in.a rotatably driYen casing. The outer ~ :~
shell includes a thin upstanding cylindrical side wall portion : :~ :
23 which terminates at its upward or downline end in an outwa.-dly and then upwardly directed.rim portion 24, and at its downward or upline end in an angular portion 25 joining ~ flat bottom . wall portion 26. Similarly, the inside shell.12 includes a ~
thin upstanding cylindrical side wall portion 27, an inwardly ~ :
and then upwardly directed downline portion 28, and an angular portion 29 ~oining a flat bottom wall portion 30. The interior.
surfaces of tha side wall portions 23 and 27 together define a ,: ,, separation channel 31 within processing chamber 13 within ~hich ; ~.
~ ~ 20 ~BC, WBC and plasma co~ponents are separated from the whole ~ -. blood as it flows through the channel under the in~luence of : a centrifugal force field-. The rim portions 24 and 28 together~
de~iae a region in chamber 13 of increased width wherein the :
~ . bloo~ components separatèd within channel 31 accumulate prior ~ 25 to withdrawal through collection ports 15 and 16.
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An additional collection port 32 is provided in the rim portion 28 of inner shell 12 for the purpcse of wlthdrawing plasma as it accumulates in chamber 13. This collectlon port is connected by a length of tubing 33 to a passageway 17a in top plate 14. Similarly, tubing 18 connects to a passageway 17b and tubing 20 connects to a passage~ay 17c in top plate 14.
To provid~ means for admitting whole blood into separation channel 31 the inner shell 12 is provided with an inlet port 34 along the axis of rotation of casing 22. This port is ;
connected by a tubing segment 3S to a passage~ay 17d in cover member 14. Additional ap rtures 36 may be provided through the bottom wall portions 26 and 3~ of the inner and outer shells to ~racilitate installation o~ the separator 10 in a seal-Iess type centrifugal apparatus in a manner to be descr1bed presently.
To provide fluid co~lmunication between the inlet and coliection ports and the non-rotating portions of the flow . .
system associated with the separator a rotating qeal assembly 40 is provided on top plate 14 along the axis of rotation of Gasing 22, This seal as~embly~ which may be conventional in constructlon and operation, i5 mounted to top plate 19 by means -- o suitable ~astening devices such as bolts 41. Referrlng to Figure 2a, the rotating seal assembly consists of a rotating member 43 having a plurality of rlng-shaped recesses 44 therein and a stationary member 45 having a plurality of co~municating ring-shaped recesses 46 therein.~ Individual .~
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lands 47 are provided hetween respective ones of the recesses to maintain fluid isolation and additional irrigation and/or ;lubrication flow systems may be provided ~or improved operation in a manner well known to the art.
In practice, two passageways are proYided in top - plate 14 for each ring-shaped recess associated with a frac-tional component, and each of these passageways may in turn be connected by an appropriate Y-connector and appropriate lengths of connecting tubing to reSpQCtive ones of the four collection ports associated with that fraction. These connections ha~e not been shown in Figure 2 for the s~ke o~ clarity.
The upper non-rotating portion 45 of the rotating seal assembly 40 is held in a stationary non-rotating position in compression-engagement with the lower rotating portion 43 by means o a retaining arm 48 mounted on the frame of the centri~ugation àpparatùs. The lower ro~ating portion of the seal may consist of a polished ceramic disc a~tached to member 14 by means o~ concentric silastic 0-rings which establish ~ ~
~luid communication between recesses 44 . and appropriate ~-. ~ . ~,~ .
- 20 ones of passageways 17, The ~pper-stationary portion~of the seal i6 formed of stainless steel lapped to insure perfect contact with the ceramic disc. Each of the ring-shaped recesses 46 thereon is connected by a passageway to a tublng port
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57;~5 4 disposable single-use favored for avoiding contaminatlon.
UMM~RY OF T~IE INVENTION_ In one particular aspect the presene inventiGn provides a disposable continuous flow centrifugal separat~r for use in con~uncation with centrifugation apparatus including a rotatably driven casing for separating fractions from a whole Eluid, said separator comprising, in combination: a mold~d outer shell received within said casing in rotatably-locked relation therewith; a molded inner shell disposed within said outer shell in spaced relation thereto, said inner and outer shells including wall portlons forming between their inner surfaces a separation chamber radially spaced from the axis of rotation of the casing, the wall portion of said - outer shell being relatively thin and deformable and resiliently biased toward said inner shell when seated in said casing; means including a plurality of pro;ections on at least one of said inner ; surfaces in abutting engagement with the other of said inner surfaces . .
for establishing a predetermined concentricity between said wall portions; inlet means including an inlet port for supplying whole blood to be processed to said separation chamber; and outlet means including a plurality of collection ports communicating with said separation chamber at respective radial distances from said a~is of rotation for removing respective separated fractions from said chamber.
In another particular aspect the present invention pro- :
vides a disposable continuous-flow centrifugal blood separator for use in conjuncation with centrifugation apparatus including a rotatably-driven bowl-shaped casing for separating ~BC, WBC and plasma fractions from whole blood, said separator comprising, in combination: a molded outer bowl-shaped shell received within said casing in rotatably-coupled relationship thereto; a molded bowl-~
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shaped lnner shell disposed within said outer shell in spaced relationship thereto, said :Lnner and outer shells including generally cylindrical upstanding wall portions forming therebetween a thin sleeve~shaped separation chamber radially-spaced from the axis of rotation of the casing, the wall portion of said outer shell being relatively thin and deformable whereby said shell is deformed toward the wall of said inner shell when seated 'in the casing; means ~ including a plurality of pro~ections on the inside surface of at : least one of said wall members in abuttlng engagement with the inside surface of the other of said wall members for establishing ~:
a predetermined concentricity between said wall portions; inlet means including an inlet port for supplying whole blood to be processed t~ said separation chamber; and outlet means including a plurality of collection ports communicating with said separation chamber at respective radial spacings from said axis of rotation :.
: to remove respective ones of the separated blood fractions from said chamber.
; In a further particular aspect the present invention provides a system for continuous centrifugal processing of whole `` 20 blood into separated fractions comprising, in combination: centri-fugation apparatus including a rotatably driven ciasing having a bowl-shaped recess therein; a molded ou~er shell seated within said recess, and rotatably coupled thereto; a molded inner shell disposed within said outer shell in spaced relationship thereto;
said inner and outer shells including wall portions forming ther.e-: between a separatlon chamber radially spaced from the axis of : rotation of the casing, said wall portion o~ said outer shell being . relatively thin and de~ormable and inwardly biased by said casing;
:pacing means including projections on the inside surface of at lea:st 30 ~ :
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one of said wall portLons in abutting engagement with the inside surface of the other oE said wall portions for establishing a pre-determined concentricity between said wall portions; inlet means including an inlet port for supplying whole blood to be proce~sed to said separation chamber; outlet means including ~ plurality of collection ports communica~ing with said separation chamber at respective radial spacings from said axis of rotation to remove respective separated blood fractions from said chamber; and fluid transfer means for conveying fractions of said whole blood developed at said collection ports to respective storage or utilization means.
BRIEF DESCRIPTION OF T~IE DRAWINGS
The features of the present invention ~hich are believed to to be no~el are set forth with particularity in the appended clalms.
The invention together with the further objects and advantages - thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify like - elements, and in which:
Fig~re 1 is a perspective view of a centrifugal blood separator constructed in accordance with the invention partially broken away to show the internal construction thereof.
Figure 2 is an enlarged cross-sectional view of the blood separator installed in a rotating seal type centrifugation apparatus.
Figure 2a is an enlarged cross-sectional view of the rotating seal assembly utilized in the apparatus shown in Figure 2.
Pigure 3 is an enlarged cross-sectional view of the downline end of the processing channel illustrating the distribution of fractionated components therein.
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Figure 4 is a diagrammatic representation of the flow system utilized in conjunction with the centrifugal blood separator of the invention.
Figure 5 is a cross-sectional view of the centrifugal blood installed within a seal-less centrifugation apparatus.
Description of the Preferred Embodiment Referr~ng to the Figures, and partlcularly to Figure 1, a centrifugal blood separator 10 constructed in accordance ~ith the invention includes a bowl-shaped outer shell 11 dimensioned to fit within a similarly shaped recess in a ro-tatably driven casing (not shown in Figure 1). A bowl-shaped inner shell 12 is disposed within the oute: shell and forms ;
therewith a centrifugal processing chamber 13 within which fractionation of whole blood takes place during rotation of the separator assembly. The rims of the two bowl-shaped shells ~
are joined by cemented tongue-and-groove attachments to a flat ;?
cover member 14 which includes four red blood cell (RBCj ; collection ports LS arranged in a first ring, and four white blood cell (WBC) collection ports 16 arranged at equal inte~vals in a second ring concentric with the first ring but of lesser diameter. The cover member also includes a plurality of aper~
tures 17 at its center for establishing fluid communication ~ith ~ - .
a rotating seai (not shown in Figure 1) in a manner~to be described pxesently. Each of the four collection ports 15 is connected to a length of tubing 18 which extends through an ~' ' , ~,:
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aperture l9 in cover member 14 and into the interior o~ the bowl-shaped inner shell 12. Similarly, each o~ the collection .
ports 16 is connected to a length of tubing 20 which extends .
. through an aperture 21 and into the interior of the inner shell ;
member. :
keerring to Figure 2, wherein the centrifugal . separator unit is shown in conjunction with a rotating-seal type centrifugation apparatus, the outer shell ll o~ the :~ .
separator is seated in.a rotatably driYen casing. The outer ~ :~
shell includes a thin upstanding cylindrical side wall portion : :~ :
23 which terminates at its upward or downline end in an outwa.-dly and then upwardly directed.rim portion 24, and at its downward or upline end in an angular portion 25 joining ~ flat bottom . wall portion 26. Similarly, the inside shell.12 includes a ~
thin upstanding cylindrical side wall portion 27, an inwardly ~ :
and then upwardly directed downline portion 28, and an angular portion 29 ~oining a flat bottom wall portion 30. The interior.
surfaces of tha side wall portions 23 and 27 together define a ,: ,, separation channel 31 within processing chamber 13 within ~hich ; ~.
~ ~ 20 ~BC, WBC and plasma co~ponents are separated from the whole ~ -. blood as it flows through the channel under the in~luence of : a centrifugal force field-. The rim portions 24 and 28 together~
de~iae a region in chamber 13 of increased width wherein the :
~ . bloo~ components separatèd within channel 31 accumulate prior ~ 25 to withdrawal through collection ports 15 and 16.
~ , ' ' . ;, .
,. .. ~.~
' ~
3L~9S72~ `
. . :
An additional collection port 32 is provided in the rim portion 28 of inner shell 12 for the purpcse of wlthdrawing plasma as it accumulates in chamber 13. This collectlon port is connected by a length of tubing 33 to a passageway 17a in top plate 14. Similarly, tubing 18 connects to a passageway 17b and tubing 20 connects to a passage~ay 17c in top plate 14.
To provid~ means for admitting whole blood into separation channel 31 the inner shell 12 is provided with an inlet port 34 along the axis of rotation of casing 22. This port is ;
connected by a tubing segment 3S to a passage~ay 17d in cover member 14. Additional ap rtures 36 may be provided through the bottom wall portions 26 and 3~ of the inner and outer shells to ~racilitate installation o~ the separator 10 in a seal-Iess type centrifugal apparatus in a manner to be descr1bed presently.
To provide fluid co~lmunication between the inlet and coliection ports and the non-rotating portions of the flow . .
system associated with the separator a rotating qeal assembly 40 is provided on top plate 14 along the axis of rotation of Gasing 22, This seal as~embly~ which may be conventional in constructlon and operation, i5 mounted to top plate 19 by means -- o suitable ~astening devices such as bolts 41. Referrlng to Figure 2a, the rotating seal assembly consists of a rotating member 43 having a plurality of rlng-shaped recesses 44 therein and a stationary member 45 having a plurality of co~municating ring-shaped recesses 46 therein.~ Individual .~
. '~
lands 47 are provided hetween respective ones of the recesses to maintain fluid isolation and additional irrigation and/or ;lubrication flow systems may be provided ~or improved operation in a manner well known to the art.
In practice, two passageways are proYided in top - plate 14 for each ring-shaped recess associated with a frac-tional component, and each of these passageways may in turn be connected by an appropriate Y-connector and appropriate lengths of connecting tubing to reSpQCtive ones of the four collection ports associated with that fraction. These connections ha~e not been shown in Figure 2 for the s~ke o~ clarity.
The upper non-rotating portion 45 of the rotating seal assembly 40 is held in a stationary non-rotating position in compression-engagement with the lower rotating portion 43 by means o a retaining arm 48 mounted on the frame of the centri~ugation àpparatùs. The lower ro~ating portion of the seal may consist of a polished ceramic disc a~tached to member 14 by means o~ concentric silastic 0-rings which establish ~ ~
~luid communication between recesses 44 . and appropriate ~-. ~ . ~,~ .
- 20 ones of passageways 17, The ~pper-stationary portion~of the seal i6 formed of stainless steel lapped to insure perfect contact with the ceramic disc. Each of the ring-shaped recesses 46 thereon is connected by a passageway to a tublng port
3 ~ on the top of the disc.
Referring to Figure 4, the RBC outlet port is connected ~ ;~
: `
~ . `' ` ` ''''1 ~L~57~:5~ : ~
by a tubing segment 50 to a peristaltic pump 51, the WBC outlet port is connectid by a tubing segment 52 to a peristaltic pump - 53, and the plasma outlet port is connected by a tubing segment 54 to a peristaltic pump 55. Whole blood is supplied to the :
inl~et port by a tu~ing segment 56, to which acid citrate dextrose ~
(ACD~and Eleparin are introduced through respective tubing , segments 57 and 58 and a peristaltic pump 59. Saline is . ~:
supplied to the rotating seal for isolation purposes through a tubing segment 60 and exhausted through a 'ubing segment 61.
Saline is supplisd to the seal for lubrication purposes by means of a tubing segment 62 and a peristaltic pump 63.
The white blood cells, red blood cells and plasma .
derived by the system may be pumped to respective collection , bags for storage or may be returned to the donor as required. :
`. lS Various safety devices may be incorporated into the system to ~:
guard against leakage of air or undue temperature rise, or - the occl~lsion of a vein in the donor. ~ :~
Casing 22.is mounted on a drive shaft 64 which in ~:
: turn is rotatably driven by means of a motor 65. In practice, . - _ : . ~
this drive arrangement is designed and conetructed to provide ~,~ . . a very high degree of concentricity in the rotation of casing 2? to insure eficient operation of the separation process and :
efficient operation o~ the seal assembly 40.
In operation, casing 22 i6 rotated at approximately ~-800 rpm to establish a centrifugal force field across separation ~ `. '.:
_g_ . ' ~ ~" - ' .
r ~
` 1057Z54 channel 31. The Flow path is neYt primed with sterile saline solution and all air bubbles are removed by back-flushing the system through the WBC peristaltic pump 53 Whole blood Is then admitted through tubing 56 rotating seal assembly 40 and tubing segment 35 to inlet port 34. The whole b100d flows radially outwardly withln chamber 13 and upwardly through separation channel 31. The centrifuge speed is now adjusted tp achTeve separation of the RBC WbC and plasma components in the manner illustrated in Figure 3. Separation begins as the blood flows up the slde of the bowl toward the collection ports the blood eventually separating into three concentric bands wlth the dense red blood cells outermost the less-dense white blood cells or buffy coat at an intermediate radius and the Ieast dense plasma at the shortest radius. Platelets are generally dis-tributed among all three regions but can be concentrated somewhat by varying the centrifuge speed. Collectlon ports 15 16 and 32 remove the components from processing chamber 13 for collection or return to the donor as desired Typically the flow rate of the whole blood in chamber 13 i5 such that the residence time of the blood in the chamber i5 about three minutes. To insure that separation of the blood components will take place within this relatively short period of time it Ts necessary that the width of the separation channel 31 be very small typically in the order of 1.5 mm or less. To obtain efficient separation of the blood components : ' ~' ~ . , ' ~ '" ' . - `' - 1 0 . :` ' .
, ' ` -.
,.
': . . :
' :` . - ' ' `'' :
.. , .~. , .. , ,, ~ , . . . . . ..
~L05~Z54 this dim~nsion must be maintained with a high degree of con-centricity so that the components as they separate will flow :
upwardly to the col].ection area at the upper e~d of chamber 13. ~:
To insure that the desired separation channel width ..
S is maintained with the desired degree of concentricity, the outer and/or inner shell members are provided, in accordance with the invention, with a plurality of inwardly-pxdjecting .
integrally-molded spacing bosses 60 which bear against their -:
. opposing shell surface to maintain accurate spacing. To insure :, .
that these bosses will in fact be determinative of the inter-element spacing, the outer shell 11 is dimensioned such that when the separator unit 10 is seated in casing 22 the side ~alls of the outer shell are caused to deform inwardly to a slight . extent. This deformation is sufficient to bring the spacing : ~bosses 60 into engagement wit:h their opposing wall surfaces and . :
, assuxe that the desired spaci.ng is established and maintained. ~
~ ~o faailitate insertion of the separator unit in casing.22 the `~ outer shell is preferably ~o~med with a slight inward taper, .
. ` typacally in the order of one degree, and the inner wall of :
l~ ~ 20 caaing 22 is formed with a complimentarily taper. ~ ~
'. - The inner and outer shells are preferably molded of - :~
:. : a poiycarbonate plastic such as Lexan (a trademark of General ~
Plastic Corporation) by m~ans of conventionaI molding techniques. .
~ The s~dewalls 23 and 27 of these shel1s may have a thickness .-` 25 o~ 0.125 inch to ootain the desired inward deformation when the :
~,, 1 , : i .. , :: . : . : . -.. :: : . ,...... . . -.
" , , , ,, ., ,, ., . , , ~ : . .: . . - :: ::
- . . .
~57~,54 separator is seated in caslng 22. In a representative application, the separator 10 ls formed with an outside diameter of approximately 6 inches and a height of approximately 4 inches. ~ith a proc-essing channel 31 1.5 mm wide, the processing chamber 13 has a volume of approximately 140 ml.
Once the various lengths of tubing have been installed during manufacture of the separator unit 10 the volume enclosed within the inner shell 12 may be filled with a foam material 66 to prevent accumulation of significant quantities of fluid within ~he chamber. This is a safety feature to insure that any leakage will be immediately evident to the operator and will not accumulate within the rotating bowl assembly.
Referring to Figure 5, the centrifugal separator uni~ of the invention may also be utilized in conjunction with a seal~less centrifugation apparatus such as that described and claimed in co-pending Canadian Application No. 2~7,878 filed March 15, 1976~ ~;
and assigned to the present assignee. Basically, this centri-fugation apparatus includes a rotor drive assembly 70 to which a rotor assembly 71 is ~ournaled by means of a hollow support shaft 72. The rotor drive assembly 70 is journaled to a stationary hub assembly 73 by means of a vertical drive shaft 74, and includes a guide sleeve 75.
The centrifugal processing chamber 10 of the invention is seated on the rotor assembly 71. ~luid communication is ,. ..
.~
: "
',' , ''', ' ' , . , ,'', : ':, ' .
: , , , , ~ : .; : :
, ~, -~ . . . . : -, -.
.
,. : .:. , :, : ::' .... ': ' ' ~' :
~ 72ci~
established between the separator unit, whlch rotates with the rotor assembly 71, and the non-rotating portion of the flow system, which may be identical to that shown in Figure~4 except for the omission of the rotating seal member 40, by means of a four ;
channel umbilical cable 76 which extends from a central location along the axis of rotation of the separator unit downwardly through the center o~ drive shaft 72, radially outwardly through guide sleeve 75 and upwardly to a fixed axially-aligned position establised by a support arm 77. As descrlbed in the previously identified co-pending Canadian Application No. 247,878, this routing of the umbilical cable 76, together with the rotor assembly 71 and rotor drive assembly 70 being driven in the same direction with a speed ratio of 2:1, establishes fluid communication with centrifugal separator unit 10 without the cable becoming twisted.
Instead, the umbical cable is sub~ected only to flexing, or repeated partial twists about its axis through angles not in excess of 18Q
degrees, as the rotor assembly 71 rotates.
To obtain the desired 2:1 speed ratio between the rotor and rotor drive assembly two pairs of idler pulleys 78 are mounted 28 on rotor drive assembly 70. A drive belt 79 is routed over these pulleys and around a stationary ring-type pulley 80 mounted on hub 73 at one end, and around a rotor drive pulley 81 carried on the bottom end of the rotor drive shaft 72 at its other end. As the rotor drive assembly 70 is rotated ~-. . ~.~ '.
:, ' ' ~ ,;:
~ . . ~, .
. ~ . .
'' '.13 . ~
30 ~
:' ~:: . . . . . . - . , - . . ~ .. ~ ,, : , 10572~4 ` I
cloGkwise by means of a motor ~not shown) driving drive shaft 74, drive belt 79 establishes a clockwise rotation of rotor assembly 71. Assuming that stationary pulley 80 and rotor drive pulley 81 h~ve the same diameter, the rotational speed of rotor assembly 11 will be sxactly twice that of rotor drive assembly 70, by reason of the combined effect of the direct 1:1 drive relationship established by pulleys 80 and 81 and the planetary motion of idlPr pulleys 78 about the rotational axis of rotor assembly 71.
In order that the centrifugal separator unit 10 can be seated in rotor assembly 71 the tubing segments 18, 20 and 33 associated with collection ports 15, 16 and 32 are routed thr~ugh the center of the separator unit and down through aper-tures 36 in the bottom walls of the inner and outer shell members. A casing 82, which may be similar to casing 22 in all respects except for the provision of passageways 83 in its bottom wall for accommodatina the connecting conduit segments, i5 mounted on rotor assembly 71 to receive the centrifugal .
separator unit. ~s with the previously descrîbed rotati~g seal ~ i embodiment, the wall of the outer shell is compres~sed by casing . 82 to obtain a separation channel 31 having a high degsee of co=centricity. The individual co=necting~tubing segments ater passing through passageways 83 are joined into umbilical cable i~.
76.
It is contemplated that the centrifugal separator -14~
'-' . ' ' ' .' ", , . - . . , , ;. , ::: : ;. . : : : : ~ . : ., ~: ,, : . . :
1057Z5~ ` I
unit 10 when intended for use in a seal-less centrifugation apparatos such as that shown in Figure 5 would be manufactured as a single integral disposable unit in which umbilical cable 76 is included. To install this unit in the apparatus the free end of the umbilical cable could be threaded downwardl~
through the hollow rotor support shaft 7~ and then radially outwardly and upwardly through slaeve 75 to support arm 77.
The free end of the cable would then bs pulled through until the separator unit was seated in casing 82. After use, the entire assembly would be removed from the apparatus and disposed of.
A centrifugal blood separator unit has been shown and described which provides efficient processing of blood into its constituent component:s. The separator unit can be economically formed by known molding techniques, and by reason ~-Or its low cost o~ manufacture, is ideally suited for disposable ¦
one-time use situations wherei.n the dangers of contamination ¦
to the donor from prior uses are completely avoided. - ¦ -While particular embodiments of the invention have been shown and described, it will be obvious to those skilled in the art that changes and moRifications may be made without ~
departing from the invention in its broader aspects, and,t~ere-: ~ ,, ors, the aim in the appended cIaims is to cover all such changes and modifications as fall within the true spirit and scope of the invention. `~
-15~
~ , ~ ~:
~ ::
'.'' '' . 5 ' ' ' ' ; ' ' ' ' '' ' . ' ', . '' . . .' ' ~ :
72Si~L
As is best shown In Fig. 3, a concentric lip 16L is providcù having an Inncr surface all¢ned with thc outer sidc of the white blood celt collection ports 16, and the adjacent bottom surface of the cover member 14 Is provlded with a concentricgroove 16G into wlllcll the ports 16 open, The provlsion of thls groove and llp has }esulted in experimentally verifled better separation oE the red hlood celks from the collected whlte blood cells.
It has been found In one bowl that only four spacer unlts 60 need to be employed and that the spacer flange between the inner and outer shells at 36 serves to not only fix the horizontal wall (bottom to top) spacing but also, to a significant degree, to fix the side walt spacir~. In one embodiment only four spacers 60 were used s ~ccessfully. Tllese were positioned near the upper surface at equal spacing around the unit. One experimental bowl whlch was constr~ted in accordance with the present invention was made of polycarbonate molded in four parts and had an overall height of approximately four inches and a diameter of approximately six and one-eighth inches. This particular unit had a fluid capacity of only 143 ml which compares favorably with the prior art bowls of this tvpe.
The shells 11 and 12 were of approximately 1/8 inch th~ckness and main-tialned a spacing of 0. 050 inches. The outer shell, although reasonably rigld for ~
..
handlingpurposes, was slightly out-oE-round and under the increased forces of ..
~0 centrifugation might have defor~ned even more. However, with-a true round casing - ~
.
- 2 29 and of stainless steel, the outer shell was upon insertlon caused to go into a true round and concentric shape.
It should be noted that the four molded ports of the bowt 10 of the two em-bodiment (Fig. 1- 2 and Fig. 53 are identical and may be adaptable to either configu-ra~ion. The present Invention allows for these ports to be manufactured with greater . . ' ' .
; ~ 16--~ ' ' ' ' '~
.
q ~
- ~3S~i'5~
dimenslonal tole}ances than Is the case with prior art permanent type bowls and yet achleve good results.
It is contemplated that thè disposable bowls of the present lnventlon of the Flg. 1- 2 type could be easlly retrofitted to existing commerclal machlnes such as the CELL~I~UGE~)separator unlt made by the American Instrument Company division of Travenol Laboratories, Inc. 9 by the securing of an appropriate casin~
In the unit. Of course, similar casings could be used to enable other brand~9 of such ;
machines to be simllarly retrofitted. ~, Although polycarbonate is the plastic presently preferred in making the outer shell and other of the blood contacting ports, other plastic materials may also - -be used, such as methyl methacrylate, styrene-acrylonitrlle, acrylic, styrene, or .
acrylonitrlle. While molding Is the presently preferred rnethod of manufacture, it is also possible to form the shells by vacuum forming or casting.
Also, although the inner shell is depicted as hollow and later preferably filled with form, the term "inner shell" should be understood in the claIms to include - ~ ~ -solid units.
~ , , : , ' : ':.
' ' :
' ' ' : ' ~ '' ~: : 1 7 :~
: ~: ~ ~
Referring to Figure 4, the RBC outlet port is connected ~ ;~
: `
~ . `' ` ` ''''1 ~L~57~:5~ : ~
by a tubing segment 50 to a peristaltic pump 51, the WBC outlet port is connectid by a tubing segment 52 to a peristaltic pump - 53, and the plasma outlet port is connected by a tubing segment 54 to a peristaltic pump 55. Whole blood is supplied to the :
inl~et port by a tu~ing segment 56, to which acid citrate dextrose ~
(ACD~and Eleparin are introduced through respective tubing , segments 57 and 58 and a peristaltic pump 59. Saline is . ~:
supplied to the rotating seal for isolation purposes through a tubing segment 60 and exhausted through a 'ubing segment 61.
Saline is supplisd to the seal for lubrication purposes by means of a tubing segment 62 and a peristaltic pump 63.
The white blood cells, red blood cells and plasma .
derived by the system may be pumped to respective collection , bags for storage or may be returned to the donor as required. :
`. lS Various safety devices may be incorporated into the system to ~:
guard against leakage of air or undue temperature rise, or - the occl~lsion of a vein in the donor. ~ :~
Casing 22.is mounted on a drive shaft 64 which in ~:
: turn is rotatably driven by means of a motor 65. In practice, . - _ : . ~
this drive arrangement is designed and conetructed to provide ~,~ . . a very high degree of concentricity in the rotation of casing 2? to insure eficient operation of the separation process and :
efficient operation o~ the seal assembly 40.
In operation, casing 22 i6 rotated at approximately ~-800 rpm to establish a centrifugal force field across separation ~ `. '.:
_g_ . ' ~ ~" - ' .
r ~
` 1057Z54 channel 31. The Flow path is neYt primed with sterile saline solution and all air bubbles are removed by back-flushing the system through the WBC peristaltic pump 53 Whole blood Is then admitted through tubing 56 rotating seal assembly 40 and tubing segment 35 to inlet port 34. The whole b100d flows radially outwardly withln chamber 13 and upwardly through separation channel 31. The centrifuge speed is now adjusted tp achTeve separation of the RBC WbC and plasma components in the manner illustrated in Figure 3. Separation begins as the blood flows up the slde of the bowl toward the collection ports the blood eventually separating into three concentric bands wlth the dense red blood cells outermost the less-dense white blood cells or buffy coat at an intermediate radius and the Ieast dense plasma at the shortest radius. Platelets are generally dis-tributed among all three regions but can be concentrated somewhat by varying the centrifuge speed. Collectlon ports 15 16 and 32 remove the components from processing chamber 13 for collection or return to the donor as desired Typically the flow rate of the whole blood in chamber 13 i5 such that the residence time of the blood in the chamber i5 about three minutes. To insure that separation of the blood components will take place within this relatively short period of time it Ts necessary that the width of the separation channel 31 be very small typically in the order of 1.5 mm or less. To obtain efficient separation of the blood components : ' ~' ~ . , ' ~ '" ' . - `' - 1 0 . :` ' .
, ' ` -.
,.
': . . :
' :` . - ' ' `'' :
.. , .~. , .. , ,, ~ , . . . . . ..
~L05~Z54 this dim~nsion must be maintained with a high degree of con-centricity so that the components as they separate will flow :
upwardly to the col].ection area at the upper e~d of chamber 13. ~:
To insure that the desired separation channel width ..
S is maintained with the desired degree of concentricity, the outer and/or inner shell members are provided, in accordance with the invention, with a plurality of inwardly-pxdjecting .
integrally-molded spacing bosses 60 which bear against their -:
. opposing shell surface to maintain accurate spacing. To insure :, .
that these bosses will in fact be determinative of the inter-element spacing, the outer shell 11 is dimensioned such that when the separator unit 10 is seated in casing 22 the side ~alls of the outer shell are caused to deform inwardly to a slight . extent. This deformation is sufficient to bring the spacing : ~bosses 60 into engagement wit:h their opposing wall surfaces and . :
, assuxe that the desired spaci.ng is established and maintained. ~
~ ~o faailitate insertion of the separator unit in casing.22 the `~ outer shell is preferably ~o~med with a slight inward taper, .
. ` typacally in the order of one degree, and the inner wall of :
l~ ~ 20 caaing 22 is formed with a complimentarily taper. ~ ~
'. - The inner and outer shells are preferably molded of - :~
:. : a poiycarbonate plastic such as Lexan (a trademark of General ~
Plastic Corporation) by m~ans of conventionaI molding techniques. .
~ The s~dewalls 23 and 27 of these shel1s may have a thickness .-` 25 o~ 0.125 inch to ootain the desired inward deformation when the :
~,, 1 , : i .. , :: . : . : . -.. :: : . ,...... . . -.
" , , , ,, ., ,, ., . , , ~ : . .: . . - :: ::
- . . .
~57~,54 separator is seated in caslng 22. In a representative application, the separator 10 ls formed with an outside diameter of approximately 6 inches and a height of approximately 4 inches. ~ith a proc-essing channel 31 1.5 mm wide, the processing chamber 13 has a volume of approximately 140 ml.
Once the various lengths of tubing have been installed during manufacture of the separator unit 10 the volume enclosed within the inner shell 12 may be filled with a foam material 66 to prevent accumulation of significant quantities of fluid within ~he chamber. This is a safety feature to insure that any leakage will be immediately evident to the operator and will not accumulate within the rotating bowl assembly.
Referring to Figure 5, the centrifugal separator uni~ of the invention may also be utilized in conjunction with a seal~less centrifugation apparatus such as that described and claimed in co-pending Canadian Application No. 2~7,878 filed March 15, 1976~ ~;
and assigned to the present assignee. Basically, this centri-fugation apparatus includes a rotor drive assembly 70 to which a rotor assembly 71 is ~ournaled by means of a hollow support shaft 72. The rotor drive assembly 70 is journaled to a stationary hub assembly 73 by means of a vertical drive shaft 74, and includes a guide sleeve 75.
The centrifugal processing chamber 10 of the invention is seated on the rotor assembly 71. ~luid communication is ,. ..
.~
: "
',' , ''', ' ' , . , ,'', : ':, ' .
: , , , , ~ : .; : :
, ~, -~ . . . . : -, -.
.
,. : .:. , :, : ::' .... ': ' ' ~' :
~ 72ci~
established between the separator unit, whlch rotates with the rotor assembly 71, and the non-rotating portion of the flow system, which may be identical to that shown in Figure~4 except for the omission of the rotating seal member 40, by means of a four ;
channel umbilical cable 76 which extends from a central location along the axis of rotation of the separator unit downwardly through the center o~ drive shaft 72, radially outwardly through guide sleeve 75 and upwardly to a fixed axially-aligned position establised by a support arm 77. As descrlbed in the previously identified co-pending Canadian Application No. 247,878, this routing of the umbilical cable 76, together with the rotor assembly 71 and rotor drive assembly 70 being driven in the same direction with a speed ratio of 2:1, establishes fluid communication with centrifugal separator unit 10 without the cable becoming twisted.
Instead, the umbical cable is sub~ected only to flexing, or repeated partial twists about its axis through angles not in excess of 18Q
degrees, as the rotor assembly 71 rotates.
To obtain the desired 2:1 speed ratio between the rotor and rotor drive assembly two pairs of idler pulleys 78 are mounted 28 on rotor drive assembly 70. A drive belt 79 is routed over these pulleys and around a stationary ring-type pulley 80 mounted on hub 73 at one end, and around a rotor drive pulley 81 carried on the bottom end of the rotor drive shaft 72 at its other end. As the rotor drive assembly 70 is rotated ~-. . ~.~ '.
:, ' ' ~ ,;:
~ . . ~, .
. ~ . .
'' '.13 . ~
30 ~
:' ~:: . . . . . . - . , - . . ~ .. ~ ,, : , 10572~4 ` I
cloGkwise by means of a motor ~not shown) driving drive shaft 74, drive belt 79 establishes a clockwise rotation of rotor assembly 71. Assuming that stationary pulley 80 and rotor drive pulley 81 h~ve the same diameter, the rotational speed of rotor assembly 11 will be sxactly twice that of rotor drive assembly 70, by reason of the combined effect of the direct 1:1 drive relationship established by pulleys 80 and 81 and the planetary motion of idlPr pulleys 78 about the rotational axis of rotor assembly 71.
In order that the centrifugal separator unit 10 can be seated in rotor assembly 71 the tubing segments 18, 20 and 33 associated with collection ports 15, 16 and 32 are routed thr~ugh the center of the separator unit and down through aper-tures 36 in the bottom walls of the inner and outer shell members. A casing 82, which may be similar to casing 22 in all respects except for the provision of passageways 83 in its bottom wall for accommodatina the connecting conduit segments, i5 mounted on rotor assembly 71 to receive the centrifugal .
separator unit. ~s with the previously descrîbed rotati~g seal ~ i embodiment, the wall of the outer shell is compres~sed by casing . 82 to obtain a separation channel 31 having a high degsee of co=centricity. The individual co=necting~tubing segments ater passing through passageways 83 are joined into umbilical cable i~.
76.
It is contemplated that the centrifugal separator -14~
'-' . ' ' ' .' ", , . - . . , , ;. , ::: : ;. . : : : : ~ . : ., ~: ,, : . . :
1057Z5~ ` I
unit 10 when intended for use in a seal-less centrifugation apparatos such as that shown in Figure 5 would be manufactured as a single integral disposable unit in which umbilical cable 76 is included. To install this unit in the apparatus the free end of the umbilical cable could be threaded downwardl~
through the hollow rotor support shaft 7~ and then radially outwardly and upwardly through slaeve 75 to support arm 77.
The free end of the cable would then bs pulled through until the separator unit was seated in casing 82. After use, the entire assembly would be removed from the apparatus and disposed of.
A centrifugal blood separator unit has been shown and described which provides efficient processing of blood into its constituent component:s. The separator unit can be economically formed by known molding techniques, and by reason ~-Or its low cost o~ manufacture, is ideally suited for disposable ¦
one-time use situations wherei.n the dangers of contamination ¦
to the donor from prior uses are completely avoided. - ¦ -While particular embodiments of the invention have been shown and described, it will be obvious to those skilled in the art that changes and moRifications may be made without ~
departing from the invention in its broader aspects, and,t~ere-: ~ ,, ors, the aim in the appended cIaims is to cover all such changes and modifications as fall within the true spirit and scope of the invention. `~
-15~
~ , ~ ~:
~ ::
'.'' '' . 5 ' ' ' ' ; ' ' ' ' '' ' . ' ', . '' . . .' ' ~ :
72Si~L
As is best shown In Fig. 3, a concentric lip 16L is providcù having an Inncr surface all¢ned with thc outer sidc of the white blood celt collection ports 16, and the adjacent bottom surface of the cover member 14 Is provlded with a concentricgroove 16G into wlllcll the ports 16 open, The provlsion of thls groove and llp has }esulted in experimentally verifled better separation oE the red hlood celks from the collected whlte blood cells.
It has been found In one bowl that only four spacer unlts 60 need to be employed and that the spacer flange between the inner and outer shells at 36 serves to not only fix the horizontal wall (bottom to top) spacing but also, to a significant degree, to fix the side walt spacir~. In one embodiment only four spacers 60 were used s ~ccessfully. Tllese were positioned near the upper surface at equal spacing around the unit. One experimental bowl whlch was constr~ted in accordance with the present invention was made of polycarbonate molded in four parts and had an overall height of approximately four inches and a diameter of approximately six and one-eighth inches. This particular unit had a fluid capacity of only 143 ml which compares favorably with the prior art bowls of this tvpe.
The shells 11 and 12 were of approximately 1/8 inch th~ckness and main-tialned a spacing of 0. 050 inches. The outer shell, although reasonably rigld for ~
..
handlingpurposes, was slightly out-oE-round and under the increased forces of ..
~0 centrifugation might have defor~ned even more. However, with-a true round casing - ~
.
- 2 29 and of stainless steel, the outer shell was upon insertlon caused to go into a true round and concentric shape.
It should be noted that the four molded ports of the bowt 10 of the two em-bodiment (Fig. 1- 2 and Fig. 53 are identical and may be adaptable to either configu-ra~ion. The present Invention allows for these ports to be manufactured with greater . . ' ' .
; ~ 16--~ ' ' ' ' '~
.
q ~
- ~3S~i'5~
dimenslonal tole}ances than Is the case with prior art permanent type bowls and yet achleve good results.
It is contemplated that thè disposable bowls of the present lnventlon of the Flg. 1- 2 type could be easlly retrofitted to existing commerclal machlnes such as the CELL~I~UGE~)separator unlt made by the American Instrument Company division of Travenol Laboratories, Inc. 9 by the securing of an appropriate casin~
In the unit. Of course, similar casings could be used to enable other brand~9 of such ;
machines to be simllarly retrofitted. ~, Although polycarbonate is the plastic presently preferred in making the outer shell and other of the blood contacting ports, other plastic materials may also - -be used, such as methyl methacrylate, styrene-acrylonitrlle, acrylic, styrene, or .
acrylonitrlle. While molding Is the presently preferred rnethod of manufacture, it is also possible to form the shells by vacuum forming or casting.
Also, although the inner shell is depicted as hollow and later preferably filled with form, the term "inner shell" should be understood in the claIms to include - ~ ~ -solid units.
~ , , : , ' : ':.
' ' :
' ' ' : ' ~ '' ~: : 1 7 :~
: ~: ~ ~
Claims (18)
PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A disposable continuous flow centrifugal separator for use in conjunction with centrifugation apparatus including a rotatably driven casing for separating fractions from a whole fluid, said separator comprising, in combination:
a molded outer shell received within said casing in rotatably-locked relation therewith;
a molded inner shell disposed within said outer shell in spaced relation thereto, said inner and outer shells including wall portions forming between their inner surfaces a separation chamber radially spaced from the axis of rotation of the casing, the wall portion of said outer shell being relatively thin and deformable and resiliently biased toward said inner shell when seated in said casing;
means including a plurality of projections on at least one of said inner surfaces in abutting engagement with the other of said inner surfaces for establishing a predetermined concentricity between said wall portions;
inlet means including an inlet port for supplying whole blood to be processed to said separation chamber; and outlet means including a plurality of collection ports communicating with said separation chamber at respective radial distances from said axis of rotation for removing respective separated fractions from said chamber.
a molded outer shell received within said casing in rotatably-locked relation therewith;
a molded inner shell disposed within said outer shell in spaced relation thereto, said inner and outer shells including wall portions forming between their inner surfaces a separation chamber radially spaced from the axis of rotation of the casing, the wall portion of said outer shell being relatively thin and deformable and resiliently biased toward said inner shell when seated in said casing;
means including a plurality of projections on at least one of said inner surfaces in abutting engagement with the other of said inner surfaces for establishing a predetermined concentricity between said wall portions;
inlet means including an inlet port for supplying whole blood to be processed to said separation chamber; and outlet means including a plurality of collection ports communicating with said separation chamber at respective radial distances from said axis of rotation for removing respective separated fractions from said chamber.
2. A disposable centrifugal separator as defined in Claim 1 wherein said inner and outer shells are bowl-shaped and said casing forms a bowl-shaped recess for receiving said outer shell.
3. A disposable centrifugal separator as defined in Claim 2 wherein said inlet port is coaxial with the axis of rotation of the separator.
4. A disposable centrifugal separator as defined in Claim 1 wherein said outlet means include first, second and third collection ports disposed at respective first, second and third spacings from said axis of rotation.
5. A disposable centrifugal separator as defined in claim 4 wherein said whole fluid comprises whole blood, and said first, second and third fractions comprise red blood cells, white blood cells and plasma, respectively.
6. A disposable centrifugal separator as defined in Claim 2 wherein said inner and outer shells include rim portions, and wherein a substantially flat cover member is secured to said rim portions.
7. A disposable centrifugal separator as defined in Claim 6 wherein at least a portion of said collection ports are in said top cover.
8. A disposable centrifugal separator as defined in Claim 6 wherein said inner shell includes at its upper end an inwardly and upwardly directed rim portion, and wherein said outer shell includes at its upper end an outwardly and upwardly directed rim portion, said rim portions forming therebetween a separator chamber of increased radial width.
9. A disposable centrifugal separator as defined in Claim 2 wherein said outer shells are made of relatively thin plastic material.
10. A disposable centrifugal separator as defined in Claim 2 wherein said inner and outer shells are molded of a thin plastic polycarbonate material.
11. A disposable centrifugal separator as defined in Claim 6 wherein said cover member includes at least one passageway for establishing fluid communication with said collection ports.
12. A disposable centrifugal separator as defined in Claim 1 wherein said projections comprise a plurality of inwardly-extending bosses on said inside surfaces of said shells.
13. A disposable centrifugal separator as defined in Claim 1 wherein projections comprise a plurality of inwardly-extending bosses on said inside surface of said one shell.
14. A disposable continuous-flow centrifugal blood separator for use in conjunction with centrifugation apparatus including a rotatably-driven bowl-shaped casing for separating RBC, WBC and plasma fractions from whole blood, said separator comprising, in combination:
a molded outer bowl-shaped shell received within said casing in rotatably-coupled relationship thereto;
a molded bowl-shaped inner shell disposed within said outer shell in spaced relationship thereto, said inner and outer shells including generally cylindrical upstanding wall portions froming therebetween a thin sleeve-shaped separation chamber radially-spaced from the axis of rotation of the casing; the wall portion of said outer shell being relatively thin and deformable whereby said shell is deformed toward the wall of said inner shell when seated in the casing;
means including a plurality of projections on the inside surface of at least one of said wall members in abutting engagement with the inside surface of the other of said wall members for establishing a predetermined concentricity between said wall portions;
inlet means including an inlet port ofr supplying whole blood to be processed to said separation chamber; and outlet means including a plurality of collection ports communicating with said separation chamber at respective radial spacings from said axis of rotation to remove respective ones of ??e separated blood fractions from said chamber.
a molded outer bowl-shaped shell received within said casing in rotatably-coupled relationship thereto;
a molded bowl-shaped inner shell disposed within said outer shell in spaced relationship thereto, said inner and outer shells including generally cylindrical upstanding wall portions froming therebetween a thin sleeve-shaped separation chamber radially-spaced from the axis of rotation of the casing; the wall portion of said outer shell being relatively thin and deformable whereby said shell is deformed toward the wall of said inner shell when seated in the casing;
means including a plurality of projections on the inside surface of at least one of said wall members in abutting engagement with the inside surface of the other of said wall members for establishing a predetermined concentricity between said wall portions;
inlet means including an inlet port ofr supplying whole blood to be processed to said separation chamber; and outlet means including a plurality of collection ports communicating with said separation chamber at respective radial spacings from said axis of rotation to remove respective ones of ??e separated blood fractions from said chamber.
15. A system for continous centrifugal processing of whole blood into separated fractions comprising, in combination:
centrifugation apparatus including a rotatably driven casing having a bowl-shaped recess therein;
a molded outer shell seated within said recess, and rotatably coupled thereto;
a molded inner shell disposed within said outer shell in spaced relationship thereto;
said inner and outer shells including wall portions forming therebetween a separation chamber radially spaced from the axis of rotation of the casing, said wall portion of said outer shell being relatively thin and deformable and inwardly biased by said casing;
spacing means including projections on the inside surface of at least one of said wall portions in abutting engagement with the inside surface of the other of said wall portions for establish-ing a predetermined concentricity between said wall portions;
inlet means including an inlet port for supplying whole blood to be processed to said separation chamber;
outlet means including a plurality of collection ports communicating with said separation chamber at respective radial spacings from said axis of rotation to remove respective separated blood fractions from said chamber; and fluid transfer means for conveying fractions of said whole blood developed at said collection ports to respective storage or utilization means.
centrifugation apparatus including a rotatably driven casing having a bowl-shaped recess therein;
a molded outer shell seated within said recess, and rotatably coupled thereto;
a molded inner shell disposed within said outer shell in spaced relationship thereto;
said inner and outer shells including wall portions forming therebetween a separation chamber radially spaced from the axis of rotation of the casing, said wall portion of said outer shell being relatively thin and deformable and inwardly biased by said casing;
spacing means including projections on the inside surface of at least one of said wall portions in abutting engagement with the inside surface of the other of said wall portions for establish-ing a predetermined concentricity between said wall portions;
inlet means including an inlet port for supplying whole blood to be processed to said separation chamber;
outlet means including a plurality of collection ports communicating with said separation chamber at respective radial spacings from said axis of rotation to remove respective separated blood fractions from said chamber; and fluid transfer means for conveying fractions of said whole blood developed at said collection ports to respective storage or utilization means.
16. A disposable centrifugal separator as defined in Claim 13 wherein said outlet means include first, second and third collection ports disposed at respective first, second and third radial spacings from said axis of rotation.
17. A disposable centrifugal separator as defined in Claim 16 wherein said fractions comprise red blood cells, white blood cells and plasma.
18. A disposable centrifugal separator as defined in Claim 13 wherein said means for establishing a predetermined spacing comprises a plurality of inwardly-extending bosses on said inside surfaces of said shells.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA314,221A CA1068657A (en) | 1976-05-14 | 1978-10-25 | Disposable centrifugal blood processing system |
| CA314,222A CA1068658A (en) | 1976-05-14 | 1978-10-25 | Disposable centrifugal blood processing system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US68729076A | 1976-05-14 | 1976-05-14 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1057254A true CA1057254A (en) | 1979-06-26 |
Family
ID=24759855
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA258,070A Expired CA1057254A (en) | 1976-05-14 | 1976-07-29 | Disposable centrifugal blood processing system |
Country Status (11)
| Country | Link |
|---|---|
| JP (1) | JPS6050497B2 (en) |
| CA (1) | CA1057254A (en) |
| CH (1) | CH624023A5 (en) |
| DE (1) | DE2717344C2 (en) |
| FR (1) | FR2350885A1 (en) |
| IL (1) | IL51629A (en) |
| IT (1) | IT1084675B (en) |
| NL (1) | NL7705334A (en) |
| NO (1) | NO146848C (en) |
| SE (1) | SE427138B (en) |
| SU (1) | SU1072794A3 (en) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4094461A (en) * | 1977-06-27 | 1978-06-13 | International Business Machines Corporation | Centrifuge collecting chamber |
| JPS5819344B2 (en) * | 1979-02-26 | 1983-04-18 | テルモ株式会社 | fluid centrifuge |
| US4344560A (en) * | 1979-11-02 | 1982-08-17 | Asahi Kasei Kogyo Kabushiki Kaisha | Container, apparatus and method for separating platelets |
| US4389206A (en) * | 1980-10-09 | 1983-06-21 | Baxter Travenol Laboratories, Inc. | Centrifugal processing apparatus and rotatable processing bowl apparatus |
| GB8521867D0 (en) * | 1985-09-03 | 1985-10-09 | Fisons Plc | Centrifuge |
| US4834890A (en) * | 1987-01-30 | 1989-05-30 | Baxter International Inc. | Centrifugation pheresis system |
| US4939087A (en) * | 1987-05-12 | 1990-07-03 | Washington State University Research Foundation, Inc. | Method for continuous centrifugal bioprocessing |
| DE19728089A1 (en) * | 1997-07-02 | 1999-01-07 | Fresenius Ag | Cell suspension separation |
| DE19810195A1 (en) * | 1998-03-10 | 1999-09-23 | Reinhard Salinger | Specific blood product extracted from patient blood using a laminar flow system |
| IT1311989B1 (en) | 1999-03-30 | 2002-03-22 | Giammaria Sitar | PROCEDURE FOR ISOLATING FETAL CELLS PRESENT IN THE PERIPHERAL BLOOD. |
| US6500107B2 (en) * | 2001-06-05 | 2002-12-31 | Baxter International, Inc. | Method for the concentration of fluid-borne pathogens |
| US20060226087A1 (en) * | 2005-04-08 | 2006-10-12 | Mission Medical, Inc. | Method and apparatus for blood separations |
| JP5285060B2 (en) * | 2008-03-12 | 2013-09-11 | 山科精器株式会社 | Centrifuge |
| CA3102600C (en) * | 2018-06-08 | 2024-06-11 | Pneumatic Scale Corporation | Centrifuge system for separating cells in suspension |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| UST955355I4 (en) * | 1959-06-24 | 1900-01-01 | ||
| US3489145A (en) * | 1966-08-08 | 1970-01-13 | Surgeon General Of The Public | Method and apparatus for continuous separation of blood in vivo |
| US3655123A (en) * | 1966-08-08 | 1972-04-11 | Us Health Education & Welfare | Continuous flow blood separator |
| US3519201A (en) * | 1968-05-07 | 1970-07-07 | Us Health Education & Welfare | Seal means for blood separator and the like |
| DE2353227A1 (en) * | 1973-10-24 | 1975-05-07 | Rohe Scientific Corp | SAMPLE CONTAINERS FOR USE IN CENTRIFUGATION |
| US4059108A (en) * | 1974-08-15 | 1977-11-22 | Haemonetics Corporation | Process for pheresis procedure and disposable pheresis bowl therefor |
| US3955755A (en) * | 1975-04-25 | 1976-05-11 | The United States Of America As Represented By The United States Energy Research And Development Administration | Closed continuous-flow centrifuge rotor |
-
1976
- 1976-07-29 CA CA258,070A patent/CA1057254A/en not_active Expired
-
1977
- 1977-03-08 IL IL51629A patent/IL51629A/en unknown
- 1977-03-17 FR FR7708053A patent/FR2350885A1/en active Granted
- 1977-04-07 SE SE7704127A patent/SE427138B/en unknown
- 1977-04-19 DE DE2717344A patent/DE2717344C2/en not_active Expired
- 1977-04-26 CH CH517377A patent/CH624023A5/en not_active IP Right Cessation
- 1977-05-03 NO NO771540A patent/NO146848C/en unknown
- 1977-05-09 IT IT23345/77A patent/IT1084675B/en active
- 1977-05-10 JP JP52054173A patent/JPS6050497B2/en not_active Expired
- 1977-05-13 NL NL7705334A patent/NL7705334A/en not_active Application Discontinuation
- 1977-05-13 SU SU772481957A patent/SU1072794A3/en active
Also Published As
| Publication number | Publication date |
|---|---|
| DE2717344A1 (en) | 1977-11-24 |
| NL7705334A (en) | 1977-11-16 |
| JPS6050497B2 (en) | 1985-11-08 |
| IT1084675B (en) | 1985-05-28 |
| NO146848C (en) | 1982-12-22 |
| JPS52138761A (en) | 1977-11-19 |
| CH624023A5 (en) | 1981-07-15 |
| FR2350885B1 (en) | 1982-06-11 |
| SU1072794A3 (en) | 1984-02-07 |
| NO146848B (en) | 1982-09-13 |
| SE7704127L (en) | 1977-11-15 |
| DE2717344C2 (en) | 1987-02-05 |
| IL51629A (en) | 1979-11-30 |
| SE427138B (en) | 1983-03-07 |
| FR2350885A1 (en) | 1977-12-09 |
| NO771540L (en) | 1977-11-15 |
| IL51629A0 (en) | 1977-05-31 |
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