U.S. patent number 3,891,553 [Application Number 05/446,363] was granted by the patent office on 1975-06-24 for serum and plasma separator -- constrictionless type.
This patent grant is currently assigned to Becton, Dickinson and Company. Invention is credited to Waldemar A. Ayres.
United States Patent |
3,891,553 |
Ayres |
June 24, 1975 |
Serum and plasma separator -- constrictionless type
Abstract
A self-contained fluid separator assembly capable of separating
blood into its component parts of plasma or serum, the light phase,
and cellular portion, the heavy phase, is disclosed. The assembly
comprises a container having a first open end for receiving blood
for subsequent separation, a second open end for removing separated
plasma or serum and closures sealing the open ends of the
container, the closures being formed of a self sealing elastomeric
material which is penetrable by a cannula. A piston is slidably
disposed in the container having its lateral outer surfaces in
sealing contact with the inner surface of the container. Pressure
responsive valve means is provided on the piston which is normally
closed when there is a minimum pressure differential on each side
of the piston and the valve means automatically opens in response
to a substantial pressure differential so that when the container
is subjected to centrifugal force the blood separates into its
light phase and heavy phase and the valve means automatically opens
with the light phase passing through the valve means so that the
piston moves down through the light phase while retaining sealing
engagement with the inner surface of the container. Filter means is
mounted on the piston so as to filter the light phase prior to its
reaching the valve means. When the piston descends to the interface
the heavy phase cellular material clogs the filter, thereby
preventing flow of fluids and solids to the valve. The
incompressible heavy phase beneath the piston stops further piston
descent, the pressure differential is terminated and the valve
means automatically shifts from the open position to the closed
position to provide an impervious barrier between the separated
phases of the blood.
Inventors: |
Ayres; Waldemar A. (Rutherford,
NJ) |
Assignee: |
Becton, Dickinson and Company
(East Rutherford, NJ)
|
Family
ID: |
23772304 |
Appl.
No.: |
05/446,363 |
Filed: |
February 27, 1974 |
Current U.S.
Class: |
210/136; 210/314;
210/359; 210/516; 210/789; 422/918 |
Current CPC
Class: |
B01L
3/50215 (20130101) |
Current International
Class: |
B01L
3/14 (20060101); B01d 021/26 () |
Field of
Search: |
;23/23B,258.5,259,292
;128/2F,214R,218M,272
;210/83,84,131,359,514-518,DIG.23,DIG.24,136,314 ;233/1A,1R,26 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Spear, Jr.; Frank A.
Assistant Examiner: Mukai; Robert G.
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 light phase of plasma or serum and heavy
phase or cellular portion comprising:
a. a container having a first open end which is adapted to receive
blood for subsequent separation into a light phase and a heavy
phase and a second open end for removing the separated light
phase;
b. closures sealing the open ends of the container, the closures
being formed of a self sealing elastomeric material which is
penetrable by a cannula;
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 for providing sealing
engagement with an inner surface of the container;
d. pressure responsive valve means associated with said piston,
said valve means being constructed and arranged to be normally
closed when there is a minimum of pressure differential on opposite
sides of the valve means and which automatically opens in response
to a substantial pressure differential 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 surfaces of the container; and
e. filter and stop means associated with said piston which
comprises a first filter member which has a porosity selected such
that it will pass red blood corpuscles and serum therethrough but
will not pass fibrin and fibrous constituents of blood and a second
filter member which has a porosity selected such that it will pass
serum but will not pass red blood corpuscles therethrough; said
first filter being mounted on said piston in a position wherein the
light phase of the blood which is filtered passes therethrough
before contacting said second filter member.
2. The self-contained fluid separator of claim 1 wherein said
container comprises a tubular body open at each end in which
closures formed of elastomeric material are mounted in sealing
engagement with the tubular body and a piston disposed adjacent one
of said closures.
3. The self-contained fluid separator of claim 1 wherein the piston
includes a rigid tubular sleeve mounted in a generally tubular body
portion formed of elastomeric material and having a plurality of
spaced axial sealing rings on its outer portion for sealing
engagement with the inner wall of the container and a diaphragm
forming a wall across one end of the generally tubular elastomeric
sleeve and wherein said valve means is comprised of at least one
resilient aperture formed in said diaphragm.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention concerns apparatus for the separation and isolation
of blood plasma and blood serum from blood mixtures.
2. Brief Description of the Prior Art
It is known to separate blood into its component parts by
centrifugation, particularly employing a sealed container such as
is disclosed in U.S. Pat. No. 2,460,641. This patent discloses a
container having a closure at its open end which is capable of
being penetrated by a cannula through which blood passes into the
container. Clinical laboratories have heretofore used this device
to collect a blood sample for subsequent separation into a light
phase, i.e. the serum or plasma and the heavy phase, i.e. the
cellular portion. The light phase is then decanted from the
cellular portion by any conventional means, for example by the use
of a syringe fitted with a cannula, or a pipette, or the like.
An apparatus also heretofore employed for the separation of blood
is disclosed in U.S. Pat. No. 3,508,653. This patent discloses a
self-contained assembly for separation of body fluid such as blood
in which a deformable piston is disposed in the container and is
positioned initially adjacent the stopper for closing the
container. After the blood to be separated is in the container the
assembly is centrifuged. After the blood is separated, increased
centrifugal force is applied to the container, the seal between the
inner surface of the container and piston is broken and the piston
is deformed, moving down through the light phase with the light
phase passing solely around the lateral surfaces of the piston and
the inner surfaces of the container. When the piston reaches the
interface between the light phase and the heavy phase, the piston
movement is stopped, the force is terminated, and the seal is
re-established between the inner surface of the container and the
resilient piston to present a barrier between the two phases.
Disclosed in my U.S. Pat. No. 3,779,383 is a serum-plasma separator
wherein the piston component is disclosed as having a valve means
in association therewith through which the light phase blood
component passes during piston descent by centrifugation. In
recognition of the fact that small particles of solid materials
normally found in blood may be carried with liquid components
through the valve means, a preferred embodiment of the apparatus
disclosed in my U.S. Pat. No. 3,779,383 has a filter disposed in
the passage leading to the valve means, however the filter element
of my prior invention is not disclosed as a type which will also
serve to stop the descent of the piston at the interface between
the two blood phases.
By the present invention the requirement for a filter element is
such that only light phase blood components pass through the valve
means. The filter means also comprises a means of stopping the
piston descent at the most desirable point, i.e. at the interface
between the separated blood phases.
Other devices known to the art are generally the filtration devices
which separate blood into its component phases such as those
disclosed in U.S. Pat. Nos. 3,481,477 and 3,512,940.
SUMMARY OF THE INVENTION
The invention is a self-contained fluid separator assembly capable
of separating blood into its component parts of plasma or serum and
cellular portion, comprising:
a. a container having a first open end which is adapted to receive
blood for subsequent separation into a light phase and a heavy
phase and a second open end for removing the separated light
phase;
b. closures sealing the open ends of the container, the closures
being formed of a self-sealing elastomeric material which is
penetrable by a cannula;
c. a piston having a specific gravity 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. pressure responsive valve means associated with said piston,
said valve means being normally closed when there is a minimum of
pressure differential on different portions of the valve means and
which automatically opens in response to a substantial pressure
differential 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 surfaces of the container; and
e. filter and stop means associated with said piston which
comprises a first filter member which will pass red blood
corpuscles therethrough but will not pass fibrin and fibrous
constituents of blood and a second filter member which will pass
the light phase of blood but which will not pass red blood
corpuscles therethrough.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a cross-sectional side elevational view of a separator
assembly of the invention illustrating a cannula penetrating one of
the closures through which blood is introduced into the container
prior to separation.
FIG. 2 is a view similar to FIG. 1 illustrating the separation of
the blood into the light phase and heavy phase with the piston
halted at the interface between phases.
DETAILED DESCRIPTION OF THE INVENTION
For a better understanding of the invention, a description of the
drawings of the illustrative embodiments is had, particularly with
respect to the embodiments shown in FIGS. 1 and 2.
Referring to FIG. 1, it is seen that the separator assembly 10
comprises a tubular member or container 12 having mounted in each
open end 11, 15 closures 14 and 16. Closures 14 and 16 are made of
a self-sealing elastomeric material, such as rubber, which are
capable of receiving cannula 18 penetrated therethrough as
illustrated in FIG. 1, for conducting blood 5 into the container.
When the cannula is removed the closure is resealed with no loss of
blood 5 passing through the penetration portion as illustrated in
FIG. 2.
Closure 14 is formed having a depending cylindrical body portion 20
and a flanged head portion 22 integrally formed therewith. 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 a pressure fit to seal the end. Head portion 30 of
stopper 16 is preferably shaped in the form of a hexagon and is
slightly greater in diameter than body portion 28 which permits the
assembly to be positioned on its side without danger of rolling. An
axial recess 24 in stopper 14 is provided for easy access through
the stopper, which reduces the force required to penetrate it with
cannula 18.
Stopper 16 is formed preferably of the same material as stopper 14.
Stopper 16 has a cylindrical body portion 28 and an integrally
formed flange head portion 30.
As shown in FIG. 1, piston 40 is held in a position adjacent to
stopper 16 by an interference fit between the inner surface 13 of
container 12 and a plurality of axially spaced sealing rings 50.
This is the normal position of piston 40 prior to separation of the
blood mixture 5.
Piston 40 includes a tubular metal insert 52 which is mounted in
annular recess 54 of piston 40. Metal insert 52 is preferably made
of stainless steel or other rigid, chemically inert material having
a specific gravity greater than blood. Piston 40 is formed of
elastomeric material and is provided with annular recess 54 which
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 surface 13 of
container 12 in sealing engagement. Piston 40 when mounted in
container 12 will maintain sealing contact with the inner surface
13 of container 12 throughout its path of travel within container
12, as hereinafter described. Integral with and joining the lateral
inner wall 46 is top wall portion of diaphragm 44 which is pierced
by at least one aperture 42. During the centrifuging operation
piston 40 is subjected to centrifugal forces tending to slide the
piston downwardly and such descent establishes a pressure
differential on opposite sides of the diaphragm 44 of piston 40.
Top wall portion or diaphragm 44 has a relatively small thickness
and lies adjacent stopper 16 in its initial position as seen in
FIG. 1.
Diaphragm 44 is made of a resilient material. Wall portion 46 and
diaphragm 44 of piston 40 define an axial annular recess or throat
80 within piston 40 which leads from the lower surface 82 of piston
40 to apertures 42. As the assembly is being subjected to
centrifugal forces the light phase which is separated from the
blood will pass into throat 80 and be guided to apertures 42 as the
piston descends through the light phase. Since the centrifugal
forces acting on the descending piston 40 will generate hydrostatic
force greater than the force of the light phase being exerted
against the top of the diaphragm 44, apertures 42 will
automatically open and will enable piston 40 to move from its
initial position of FIG. 1, downward within the confines of
container 12. Interposed in the flow path of light phase material
to apertures 42 is a fine filter element 85 which has pore sizes
which will not permit the passage of blood red cells, having an
average diameter of about 7 microns. This element 85 serves as a
stop means to halt the descent of piston 40 once it reaches the
interface between the separated lighter and heavier phases as will
be discussed more fully hereinafter. Affixed beneath filter 85
there is a different filter element 90 characterized by pore sizes
which will allow the passage of red blood cells but will not allow
the passage of particulate matter such as, for example fibrin. The
filter element 90 as shown in FIG. 1 may have an interior chamber
portion to provide increased filter surface area. This is a
preferred form of filter element 90. However a filter element 90
completely filling the remaining void in throat 80 may
alternatively be employed.
In operation, the light phase passing through filter 90 on its way
to apertures 42 is filtered to remove particles of fibrin and other
particulate matter. When piston 40 reaches the heavy phase, red
blood corpuscles contained therein pass into throat 80, through
filter 90 and are stopped from further passage by the red-blood
cell impervious filter element 85. As the red blood cells build up
on the surface of filter 85, they clog the filter and prevent the
continued flow of fluid to apertures 42. The reduction of flow and
the further incompressibility of the heavy phase halts further
descent of piston 40. This occurs when the piston 40 has reached a
point in its descent approximating the interface between light 5a
and heavy 5b separated blood phases as seen in FIG. 2. When piston
40 stops its movement in container 12 and comes to rest at the
aforementioned interface, the pressure differential on each side of
diaphragm 44 is substantially equalized and valve means 42
automatically shifts from the open position to the closed position
even though the assembly may continue to be subjected to
centrifugal forces.
As illustrated in FIG. 2, piston 40 has completed its travel within
container 12 and is stopped from further movement in container 12
by the clogging of filter 85, which acts as a stop means. With the
valve aperture means 42 closed, the piston 40 forms an impermeable
barrier between the now separated and isolated phases.
Fine filter element 85 may be made of any conventional filter
material capable of preventing the passage of red blood corpuscles
(which have an average effective diameter of about 7 microns) but
which will allow the passage of blood serum or blood plasma. The
materials employed should not produce any undesirable reaction with
blood. Illustrative of filter materials for filter 90 which may be
employed are asbestos, compacted fibers of polyolefins, plastic
foams such as polyurethane foams, polyethylene foams and the like;
sintered glass and sintered polyethylene.
When operating the separator assembly of the invention herein it is
preferred that the assembly be first evacuated of air so that when
cannula 18 penetrates closure 14 blood 5 will automatically fill
container 12. After cannula 18 is withdrawn and container 12 is
filled with blood the assembly may be placed in a centrifuge and is
separated into light and heavy phases by employing relatively low
centrifugal forces which do not cause the piston to move from its
initial position. Thereafter the rotational speed of the centrifuge
is increased which causes descent of piston 40 through the light
phase. When the centrifugal forces are terminated, the separated
and phase isolated blood samples are ready for use in a
conventional manner for the diagnosis of physical ailments.
* * * * *