U.S. patent number 3,901,219 [Application Number 05/491,820] was granted by the patent office on 1975-08-26 for blood collecting container and method.
This patent grant is currently assigned to Becton, Dickinson and Company. Invention is credited to Donald A. Kay.
United States Patent |
3,901,219 |
Kay |
August 26, 1975 |
Blood collecting container and method
Abstract
Disclosed herein is an apparatus and method for obtaining
accurate, consistent filling of an evacuated blood collecting tube
under varying atmospheric pressure conditions. The apparatus
comprises a gas-proof tubular container having one open end and one
closed end; a gas-proof, elastomeric self-sealing closure to seal
the open end; an elastomeric barrier-piston which forms a
sliding-seal with the interior side walls of the container; and an
indentation for preventing the piston from traversing the entire
length of the container. The method of the invention comprises
employing the apparatus of the invention in the collection of
mammalian blood. The apparatus and method of the invention is
particularly useful for the collection of blood with a simultaneous
admixture of a chemical additive.
Inventors: |
Kay; Donald A. (Sharon,
MA) |
Assignee: |
Becton, Dickinson and Company
(East Rutherford, NJ)
|
Family
ID: |
23953813 |
Appl.
No.: |
05/491,820 |
Filed: |
July 25, 1974 |
Current U.S.
Class: |
600/577;
422/918 |
Current CPC
Class: |
B01L
3/5021 (20130101) |
Current International
Class: |
B01L
3/14 (20060101); A61B 005/14 () |
Field of
Search: |
;128/2F,276,DIG.5,214R
;233/26 ;23/292 ;210/DIG.24 ;73/425.6,425.4R |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: McGowan; J. C.
Attorney, Agent or Firm: Kane, Dalsimer, Kane, Sullivan and
Kurucz
Claims
What is claimed:
1. Apparatus for the collection of an accurate measure of blood
which comprises:
a gas-proof tubular container having one open end and one closed
end;
a gas-proof, elastomeric, self-sealing closure sealing said open
end;
an elastomeric barrier-piston formed of an elastomeric material and
which forms a sliding-seal with the interior side walls of said
container;
means for preventing said piston from traversing the entire length
of said container;
provided that at least one of said closure and said piston has a
recess in the surface thereof which is proximal to the other of
said closure and said piston, said recess providing only the
minimum space required to allow the needle room to penetrate the
stopper and receive an initial flow of blood; and
said apparatus having a partial vacuum in all chambers within said
container.
2. Apparatus according to claim 1 wherein said self-sealing closure
has a thin zone which is penetrable by a cannula.
3. Apparatus according to claim 1 wherein said piston has integral
sealing rings in the side walls thereof for forming a seal with the
interior walls of said container.
4. A method of collecting an accurate measure of blood which
comprises:
A. providing an air-evacuated tubular container having one open end
and one closed end;
a gas-proof elastomeric self-sealing closure sealing said open
end;
an elastomeric barrier-piston formed of an elastomeric material and
which forms a sliding-seal with the interior side walls of said
container;
means for preventing said piston from traversing the entire length
of said container;
provided that at least one of said closure and said piston has a
recess in the surface thereof which is proximal to the other of
said closure and said piston, said recess providing only the
minimum space required to allow the needle room to penetrate the
stopper and receive an initial flow of blood; said apparatus having
a partial vacuum in all chambers within said container; and
B. filling said container by inserting a cannula into said recess,
said cannula being attached to a source of blood.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention concerns a method and apparatus for the collection of
mammalian blood specimens and more particularly concerns an
apparatus and method for the collection of an accurate measure of
blood specimen from a mammal.
2. Brief Description of the Prior Art
The art is replete with descriptions of method and apparatus for
the collection of mammalian blood for the purpose of diagnostic
determinations. One of the most convenient methods for the
collection of mammalian blood is within an air evacuated collection
tube such as that described in U.S. Pat. No. 2,460,641. At the
present time, however, identically evacuated blood collection tubes
will draw varying amounts of blood in different parts of the world
and on different days in the same geographic locality. This is due
to atmospheric pressure variations (which can be a result of
weather conditions or altitude differences). The accurate filling
of evacuated blood collection tubes is most critical in blood
collection tubes which contain a chemical additive for admixture
with the collected blood specimen. For example, when the evacuated
tube contains an anti-coagulant such as heparin. Too high or too
low a blood to additive ratio may cause the blood sample to give
inaccurate results in subsequent blood chemistry testing. This
could ultimately lead to an error in analysis.
Prior hereto an apparatus and means for automatically collecting a
measured amount of blood into an evacuated blood collection tube
has not been available. The apparatus and method of my invention
fills this long awaited need.
By the method and apparatus of my invention, it is now possible to
collect almost automatically, an accurate measure of blood for
clinical analysis. The collected blood may then be separated into
its liquid and substantially cellular portions without transfer to
a separate container for centrifuging. The apparatus of my
invention is a unitary, simply constructed and economical unit
which may be disposed of after a single use. The apparatus and
method of my invention are readily employed by para-medical
personnel having a minimum amount of training in accurate blood
collection and analysis techniques.
SUMMARY OF THE INVENTION
The invention comprises an apparatus for the collection of an
accurate measure of blood which comprises: a gas-proof tubular
container having one open end and one closed end; a gas-proof,
elastomeric, self-sealing closure to seal said open end; an
elastomeric barrier-piston formed of an elastomeric material and
which forms a sliding-seal with the interior side walls of said
container; and means for preventing said piston from traversing the
entire length of said container; provided that at least one of said
closure and said piston has a recess in the surface thereof which
is proximal to the other of said closure and said piston. The
invention also comprises the method of collecting an accurate
measure of blood employing the apparatus of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a cross-sectional side elevation of an embodiment within
the scope of the apparatus of the invention shown prior to its
operation.
FIG. 2 is a cross-sectional side elevation of the embodiment seen
in FIG. 1 but following its filling with blood.
FIG. 3 is a cross-sectional side elevation of the embodiment of the
invention as seen in FIG. 2 but following its centrifugation to
separate the collected blood into its light liquid component and
its heavy, substantially cellular component.
DETAILED DESCRIPTION OF THE INVENTION
The apparatus of the invention may be fabricated from conventional
materials. Illustratively, the gas-proof container may be formed of
glass. The gas-proof closures employed herein may be fabricated of
any suitable elastomeric self-sealing materials. The preferred
material for forming gas-proof closures is butyl rubber. The
methods and techniques of assembling the apparatus of the invention
will be obvious to those skilled in the art.
The apparatus of the invention and the method of the invention will
now be further described and exemplified by reference to the
various specific embodiments set forth in the drawings.
FIG. 1 is a cross-sectional side elevation of an apparatus of the
invention referred to generally by the symbol 10. Apparatus 10
comprises a gas-proof tubular container member 12 having one end
sealed with a gas-proof, penetrable closure 14 and a second end 13
which is sealed. Closure 14 is a member which may be termed a
"stopper" which may be characterized by its cylindrical body
portion 16 which is inserted under compression into the open end of
container 12 so as to maintain container 12 in a sealed gas type
engagement. Stopper 14 also has an enlarged head portion 18 to
facilitate its insertion and removal. Body portion 16 of closure 14
has an annular recess 20 therein which together with axial recess
22 in head portion 18 forms a thin penetrable zone 24 in closure
member 14. The thin penetrable zone 24 should have a minimum of at
least 0.06 inches thickness when the elastomeric material of which
stopper 14 is formed is butyl rubber. This minimum thickness
assures that the apparatus 10 will maintain a vacuum for a period
of at least 2 years. Nested beneath closure 14 is a piston-barrier
member 30 which forms an interference-sliding fit with the interior
walls 32 of container 12. Piston-barrier 30 as shown in FIG. 1 has
a central cylindrical body portion 34 and integral upper sealing
ring 36 and lower sealing ring 38 which form a sliding seal with
the interior wall 32 of container 12. Within the central body
portion 34 of piston-barrier member 30 there is an annular recess
35 which is provided as an alternate embodiment when it is desired
to add chemicals 39 to the collected blood. The chemical additive
is stored within annular recess 35 prior to the collection of
blood. The volumetric area for annular recess 35 is sufficient to
hold the chemical additive with a minimal amount of air space. The
amount of air space above the piston has a direct bearing on the
accuracy of the filling of the tube. The more space above the
piston 30 initially, the less accurate is the filling procedure. A
small amount of space is required to allow the needle room to
penetrate the stopper, but such space should be minimal.
The apparatus of the invention as shown in the embodiment of FIG. 1
may be assembled under conditions of a partial vacuum so that
chamber 40 of container 12 will have a partial vacuum contained
therein. In practice, the vacuum employed is circa 26 millimeters
of mercury.
The method of the invention is carried out by filling an evacuated
apparatus of the invention 10 with blood, upon which analysis is
desired. Referring now to FIG. 2 there is seen apparatus 10 which
has been penetrated by cannula 35 through thin penetrable zone 24
of the closure 14. The open end of cannula 37 terminates within
recess 20. Recess 20 should have a minimal volumetric capacity,
i.e.; the minimum space required to allow the needle room to
penetrate the stopper and receive an initial flow of blood. As
blood 5 enters the axial recess 20, the pressure above
piston-barrier 30 is increased over the pressure found in evacuated
chamber 40. The pressure differential causes piston-barrier 30 to
descend within container 12 while maintaining sealing engagement
with the inner walls 32 of container 12. Piston-barrier 30 will
descend within container 12 until it is stopped by constriction 44
which is integrally molded within the walls of container 12.
Constriction 44 is a stop means positioned so that upper chamber
40A has a precise volumetric capacity as required for an accurate
volumetric collection of blood. Alternatively, the stop means may
be a force fit plastic ring inserted in the container at the
desired point, or a tubular sleeve of specified length inserted in
the lower end of the container. Upon striking stop means 44,
piston-barrier 30 is halted and when the pressure in upper chamber
40A equals the pressure of incoming blood, the filling of container
12 with blood terminates and cannula 37 may be withdrawn whereupon
the thin penetrable self-sealing zone 24 seals the opening
previously made by cannula 37. When the annular recess 35 contains
a chemical additive such as heparin, sodium oxalate, potassium
oxalate or the like then the incoming blood 5 automatically admixes
therewith to result in an accurate volumetric collection of blood
in admixture with a precise amount of chemical additive previously
enclosed within recess 35. That portion of the container
represented by chamber 40B will contain residual air not evacuated
during assembly of the apparatus 10. Piston-barrier 30 forms a
permanent seal between this residual air and the collected blood so
that the collected blood is not exposed to atmospheric gases.
Following collection of blood 5, the apparatus 10 may be
centrifuged conventionally to effect a separation of the collected
blood into its lighter liquid or plasma portion and its heavier
substantially cellular portion.
FIG. 3 is a cross-sectional side elevation of a filled apparatus 10
shown following centrifugation wherein the blood has now been
separated into its light liquid portion 5A and its substantially
cellular portion 5B. To remove the light liquid portion for
chemical analysis, one may remove closure 14 and remove by
decantation or pipette the light liquid portion for chemical
analysis.
* * * * *