U.S. patent number 3,887,464 [Application Number 05/446,359] was granted by the patent office on 1975-06-03 for serum/plasma separator with centrifugal valve seal.
This patent grant is currently assigned to Becton, Dickinson and Company. Invention is credited to Waldemar A. Ayres.
United States Patent |
3,887,464 |
Ayres |
June 3, 1975 |
Serum/plasma separator with centrifugal valve seal
Abstract
A self-contained fluid separator assembly is disclosed capable
of separating blood into its component parts of plasma or serum,
the light phase, and the cellular portion, the heavy phase. The
assembly comprises a container having at least one open end for
receiving blood for subsequent separation and a closure sealing the
open end of the container. The closure is formed of a self-sealing
elastomeric material which is penetrable by a pointed hollow needle
through which the blood to be separated is conducted into the
container. A piston is slidably disposed in the container with its
outer surfaces in sealing contact with the inner surfaces of the
container. Centrifugally actuated valve means in the form of a
distortable closed end tube with side slit, normally closed, is
provided on the piston and automatically opens in response to
centrifugal force. When blood in the container is subjected to
centrifugal force it first separates into its light phase and heavy
phase. Thereafter the piston with open valve moves down through the
light phase while retaining sealing engagement with the inner
surfaces of the container. Positive stop means is provided on the
container between its ends so that the piston as it moves through
the light phase will contact the stop means and stop at a
predetermined distance above the closure bottom of the tube. Upon
termination of the centrifugal force, the valve means automatically
closes to provide an impervious barrier between the separated light
and heavy phases of the blood. SU BACKGROUND OF THE INVENTION It is
known to separate blood into its component parts by centrifugation,
for example, the assembly disclosed in U.S. Pat. No. 2,460,641.
However, this particular assembly does not employ a means for
sealing the separated plasma or serum phase from the cellular
phase. It is also known to provide assemblies for manually
separating the plasma or serum phase from the cellular phase, for
example, as disclosed in U.S. Pat. Nos. 3,586,064; 3,661,265;
3,355,098; 3,481,477; 3,512,940 and 3,693,804. In all of these
devices the serum is collectd in a blood collection container and
means are provided for separating the plasma or serum phase from
the cellular phase employing filters, valves, transfer tubes or the
like. It is also known to provide assemblies for the sealed
separation of blood in which a piston is actuated by centrifugal
force such as is disclosed in U.S. Pat. Nos. 3,508,653 and
3,779,383. These devices use either a distortable piston made of a
resilient material or valve means associated with the piston to
affect a sealed separation after centrifugation. FIELD OF THE
INVENTION The present invention relates to separators and more
particularly to a device for separating blood plasma from cellular
material of the type disclosed in commonly assigned application
Ser. No. 247,483 filed Apr. 25, 1972. SUMMARY OF THE INVENTION The
invention generally contemplates the provision of an improved
self-contained sealed fluid separator assembly capable of
separating blood into its component parts of plasma or serum as the
light phase and the cellular portion as the heavy phase and
establishing a sealed barrier therebetween without the necessity of
opening the container or decanting the separated light phase from
the heavy phase. It is an object of the invention to automatically
separate blood into its component phases by simply subjecting the
self-contained assembly to centrifugal force so that upon
completion of the centrifuging operation an impervious barrier
separates the light phase from the heavy phase of the blood. The
assembly is capable of withstanding rough handling through the
mails, inversion of the container without remixing the component
phases and preventing various chemical constituents in the light
phase from leaking into and mixing with the heavy phase or vice
versa. It is a further object of the invention to provide a
self-contained assembly for separating blood into its component
parts which is inexpensive to manufacture, simple to assemble and
easy to use. The separator assembly for separating blood into its
component parts of plasma or serum, the light phase, and cellular
portion, the heavy phase, is a self-contained unit which requires
only that a sample of blood to be separated be provided within the
container. The container is formed having at least one open end
which is adapted to receive blood for separation into its component
phases. A closure is mounted in the open end for sealing the
container, this closure being formed of a self-sealing elastomeric
material which is penetrable by a pointed hollow needle through
which blood to be separated is conducted into the container. A
piston is slidably mounted in the container having its outer
cylindrical surfaces in sealing engagement with the inner surfaces
of the container. Centrifugally actuated valve means in the form of
a distortable closed end tube with side slit, is disposed on said
piston and is normally closed when there is a minimum of
centrifugal force acting on the piston. The valve means
automatically opens in response to a substantial increase of
centrifugal force. When the container is subjected first to
moderate centrifugal force the piston stays at the top of container
12 and the blood separates into its light phase and heavy phase.
When the centrifugal force thereafter is substantially increased,
the valve means automatically opens with the light phase passing up
through the valve means while the piston moves down through the
light phase retaining its sealing engagement with the inner
surfaces of the container. A stop means is formed on the container
and disposed a predetermined distance from the bottom of the
container which is remote from the piston in its initial position.
The piston after moving through a major part of the light phase is
caused to stop when it reaches the stop means. When centrifugation
ceases, the valve means automatically shifts from the open position
to the closed position to provide an impervious barrier between the
separated light phase and heavy phase of the blood. Thereafter, the
separated sample is ready for testing.
Inventors: |
Ayres; Waldemar A. (Rutherford,
NJ) |
Assignee: |
Becton, Dickinson and Company
(East Rutherford, NJ)
|
Family
ID: |
23772295 |
Appl.
No.: |
05/446,359 |
Filed: |
February 27, 1974 |
Current U.S.
Class: |
210/117; 210/136;
210/789; 210/516; 422/918 |
Current CPC
Class: |
B01L
3/5021 (20130101) |
Current International
Class: |
B01L
3/14 (20060101); B01d 021/26 () |
Field of
Search: |
;23/23B,258.5,259,292
;128/214R,272 ;210/83,84,109,131,359,5A,518,DIG.23,DIG.24,117,136
;233/1A,1R,26 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Hart; Charles N.
Assistant Examiner: Spitzer; Robert H.
Attorney, Agent or Firm: Kane, Dalsimer, Kane, Sullivan and
Kurucz
Claims
I claim:
1. A self-contained fluid separator assembly, capable of separating
blood into its component parts of light phase plasma or serum and
heavy phase cellular portion, comprising:
a. a container having at least one open end which is adapted to
receive blood for subsequent separation into a light phase and a
heavy phase;
b. a closure sealing the open end of the container, the closure
being formed of a self-sealing elastomeric material which is
penetrable by a cannula through which blood to be separated is
conducted into the container;
c. a piston having a specific gravity relatively greater than the
cellular portion of the blood and slidably mounted in the container
and having means on an outer surface in sealing engagement with an
inner surface of the container;
d. centrifugally actuated valve means associated with said piston,
said valve means being in the form of a downwardly projecting
distortable closed end tube with a side slit and having a specific
gravity greater than blood said slit openable when the valve means
distorts due to substantial centrifugal force acting upon it, said
valve means being normally closed when there is a minimum of
centrifugal force acting on the valve means, so that when said
container is subjected to moderate centrifugal force the blood
separates into its light phase and heavy phase but the piston stays
in the upper portion of the container, and subsequently when
increased centrifugal force is used the valve means automatically
opens with the light phase passing up through the valve means
enabling the piston to move down through the light phase while
retaining sealing engagement with the inner surface of the
container; and
e. mechanical stop means on the container whereby the piston when
moving through the light phase will stop a predetermined distance
from one of the ends of the container followed by termination of
substantial centrifugal force which permits the valve means to
close to provide an impervious barrier between the separated light
phase and heavy phase of the blood.
2. A self-container fluid separator of claim 1, wherein the stop
means on the container is an annular groove interposed between the
ends of the container forming an annular constriction of the inner
surface of the container so that said piston is prevented from
passing the stop means when subjected to centrifugal forces.
3. The invention in accordance with claim 1, wherein at least one
annular sealing ring is provided on the periphery of the piston and
in sealing engagement with the interior of the container.
4. The invention in accordance with claim 1, wherein the valve
means is independent of the piston sealing means.
5. The piston of claim 1, wherein the piston includes a central
passageway and a distortable tube having an opened upper end and
forms an integral downward extension of the piston, the bore of the
tube being aligned with the piston central passageway, the bottom
end of the tube being closed, and the side slit being interposed
between the ends of the tube and extending only partially across
the tube with the uncut part of the tube opposite the slit being
the distortable zone of the tube about which distortion takes place
when the closed end tube is subjected to centrifugal force.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
For a better understanding of the invention reference is had to the
drawings which illustrate the preferred embodiments of the
invention herein.
FIG. 1 is a sectional elevational view of the separator assembly
illustrating a pointed cannula penetrating one of the closures
through which blood is introduced into the container prior to
separation with the centrifugally actuated valve in closed
position; and
FIG. 2 is a view similar to FIG. 1 illustrating the separation of
the blood into the light phase and heavy phase with the valve open
and the piston travelling towards the stop means.
DESCRIPTION OF THE PREFERRED EMBODIMENT
In FIG. 1, the separator assembly 10 comprises a tubular member or
container 12 having mounted in each of the open ends 11 and 15
closures 14 and 16. Closures 14 and 16 are made of a self-sealing
elastomeric material such as rubber. Closure 16 is capable of being
penetrated by cannula 18 for conducting blood into the container.
When the cannula is removed, the closure reseals with no loss of
blood.
Closure 14 is formed with a depending cylindrical body portion 20
and an integral flanged head portion 22. Body portion 20 has a
diameter slightly greater than the internal diameter of the
container 12 so that closure 14 when mounted into end 11 provides
an interference fit to seal this end. Head portion 22 may be shaped
in the form of a hexagon and is slightly greater in diameter than
body portion 20 which permits the assembly to be positioned on its
side without danger of rolling.
Stopper 16 has a cylindrical body portion 28 and an integrally
formed cylindrical head portion 30 having an axial recess 24. Body
portion 28 has an annular recess 29 to provide a self-sealing
penetrable zone 31 to facilitate insertion of cannula or pointed
hollow needle 18 with minimum force while maintaining a sealed
closure. As noted above, stopper or closure 14 as well as 16 is
inserted into ends 11 and 15 in compression to maintain ends 11 and
15 of container 12 in sealed gas tight engagement.
Tubular member or container 12 is formed preferably of glass but
any other suitable material may be employed. Intermediate ends 11
and 15 of tubular member 12 is an annular groove 32 forming a
constriction and a stop means 34 as a part of the inner surfaces of
container 12. Thus, as piston 40 moves from the initial starting
position illustrated in FIG. 1 to the terminal position after the
separation of the light phase from the heavy phase, the piston
comes to rest at the stop means 34. The piston may be formed of
elastomeric material and preferably has greater specific gravity
than blood so that the centrifugal valve will open and so that the
piston will move through the light phase when the increased
centrifugal force is applied to the assembly and eventually
automatically come to rest at stop means 34. The seal of the piston
with respect to the inner surfaces of the container is constant
throughout its travel from its initial position of FIG. 1 to its
terminal postion. Piston 40 includes a tubular metal insert 52
which is mounted in annular recess 54. Metal insert 52 is
preferably made of stainless steel or other rigid, chemically inert
material having a specific gravity greater than blood. Annular
recess 54 is dimensioned to receive tubular member 52 in an
interference fit so that no air space remains in annular recess
54.
The elastomeric portion of piston 40 comprises an outer wall 48 and
spaced therefrom is inner wall 46 which defines annular recess 54.
Formed integrally with wall 48 are a plurality of axially spaced
sealing rings 50 which contact the inner wall surfaces 13 of
container 12 in sealing engagement. Piston 40 when mounted in
container 12 will maintain sealing contact with inner surface 13 of
container 12 throughout its path of travel within container 12.
During high speed centrifuging piston 40 will start to move
downwardly. At the same time and in most instances before, because
of the greater specific gravity of the valve means 42 as compared
with the blood, closed end tube 44 will distort downwardly and the
side slit 45 will automatically open and will enable the separated
light phase liquid to pass upwardly through the opening and enable
piston 40 to move from its initial position of FIG. 1 to its final
position while maintaining sealing engagement with the inner wall
13 of container 12. When piston 40 stops its movement in container
12 and comes to rest on stop means 34, and when centrifugal force
is terminated the closed end tube 44 will return to its normal
position so that the side slit 45 is closed. A portion of the light
phase remains above the separated heavy phase and is not utilized
as part of the separated light phase.
When operating the separator assembly of the invention herein it is
preferred that the assembly be evacuated so that when cannula 18
penetrates closure 16 blood will automatically fill container 12.
It is also contemplated to provide a separator assembly suitable
for use with the blood collecting assembly disclosed in U.S. Pat.
Nos. 2,460,641; 3,469,572 and 3,494,352. It is important when
filling the assembly 10 that blood be introduced into container 12
through the stopper 16 mounted on the bottom of the container to
obviate the possibility of having blood cells trapped between the
piston 40 and stopper 22 which will later separate to form the
chamber where the light phase will be collected thus contaminating
the light phase with blood.
After cannula 18 is withdrawn and container 12 is filled with blood
the assembly is placed in a centrifuge and the blood is separated
initially employing moderate centrifugal forces which do not cause
the piston 40 to move from its initial position nor valve means 42
to open. This precipitates or separates the blood cells or blood
clot into the tube portion below constriction stop means 34.
Thereafter the rotational speed of the centrifuge is increased
which causes a substantial downward thrust on the piston. Before
the time piston 40 starts to move valve means 42 automatically
opens and thereafter the piston moves downwardly through the light
phase with the light phase passing up through the valve means.
Piston 40 maintains sliding and sealing engagement with the inner
surface 13 of container 12. The piston completes its movement when
it engages stop means 34 and then centrifuging is terminated. The
valve means 42 will close to thereby establish an impervious
barrier between the light and heavy phase of the blood.
The separated blood sample is ready for use. As desired, the serum
or plasma can be taken from one end and/or the concentrated red
cells can be taken from the other end.
While variations of the invention herein may be had, the objectives
of the invention have been illustrated and described.
* * * * *