U.S. patent number 3,872,730 [Application Number 05/339,023] was granted by the patent office on 1975-03-25 for sampling apparatus.
This patent grant is currently assigned to Becton, Dickinson and Company. Invention is credited to John Ronald Coy, Michael Andrew Ringrose.
United States Patent |
3,872,730 |
Ringrose , et al. |
March 25, 1975 |
SAMPLING APPARATUS
Abstract
A holder for a sealed container of the type having a piercable
self-sealing cap is slidably mounted at a lower end of an inclined
slideway. The slideway is pivotally mounted at its upper end to a
stationary base. A housing mounted to an upper end of the slideway
includes a pair of needles positioned to pierce the cap of the
container. The needles are disposed one above the other and the
uppermost needle is longer than the lower most needle. Actuating
means are provided for causing reciprocal movement of the holder
and simultaneous pivotal movement of the slideway so that the cap
is pierced by the needles. As the uppermost needle pierces the cap
it enters a bubble formed above fluid contained in the container
for purposes of equalizing the pressure within the container. The
second needle then pierces the cap as the container passes through
a horizontal position so that the second needle enters the fluid
contained in the container which flows to a position adjacent the
cap as the container is tilted. Means are provided for applying a
negative pressure to the second needle for drawing fluid out of the
container. The actuating means is then used to withdraw the holder
and container from the needles which are wiped clean by the action
of the self-sealing cap.
Inventors: |
Ringrose; Michael Andrew
(London, EN), Coy; John Ronald (London,
EN) |
Assignee: |
Becton, Dickinson and Company
(Rutherford, NJ)
|
Family
ID: |
9985757 |
Appl.
No.: |
05/339,023 |
Filed: |
March 7, 1973 |
Foreign Application Priority Data
|
|
|
|
|
Mar 10, 1972 [GB] |
|
|
11413/72 |
|
Current U.S.
Class: |
73/864.23;
604/201 |
Current CPC
Class: |
G01N
35/1079 (20130101) |
Current International
Class: |
G01N
1/00 (20060101); A61j 001/06 (); G01n 001/10 () |
Field of
Search: |
;73/421B,423A,425.4R,425.4P,425.6 ;128/272,218C,218DA,216 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Queisser; Richard C.
Assistant Examiner: Roskos; Joseph W.
Attorney, Agent or Firm: Kane, Dalsimer, Kane, Sullivan and
Kurucz
Claims
What we claim is:
1. A method of withdrawin a sample of fluid from a container which
is sealed by a cap formed from a material which can be readily
pierced by a sampling needle and which will reseal the aperture
formed by the sampling needle when the sampling needle is
withdrawn, comprising the steps of:
venting the container through the cap while maintaining the
container in substantially upright position before the sampling
needle passes through the cap, whereby the pressure in the
container is approximately equalized with atmospheric pressure;
inserting a sampling needle through the cap and into the
container;
tilting the container subsequent to venting of the container so
that the fluid is positioned adjacent the cap and the sampling
needle extends into the fluid;
withdrawing a sample of fluid from the container by applying
suction to the sampling needle; and
withdrawing the sampling needle through the cap, whereby the cap
wipes the sampling needle as it is withdrawn and thereafter reseals
the container.
2. A method as described in claim 1, wherein the container is
vented by means of a vent needle, the vent needle being passed
through the cap before the sampling needle so as to communicate an
air bubble formed above the fluid in the container with atmospheric
pressure.
3. A method as claimed in claim 2 including the additional steps of
holding the container with the cap uppermost as the vent needle
pierces the cap so that the vent needle enters the air bubble above
the fluid and thereafter tilting the container through a horizontal
position as the sampling needle passes through the cap so that the
air bubble in the container moves away from the cap and the
sampling needle enters the fluid positioned adjacent the cap.
4. Apparatus for withdrawing a fluid sample from a container which
is sealed by a cap formed from a material which can be readily
pierced by a sampling needle and which will reseal the aperture
formed by the sampling needle when the sampling needle is
withdrawn, comprising:
a housing;
a samapling needle mounted on the housing;
means for connecting the sampling needle to a suction source;
a holder for the container mounted on the housing and adapted to
hold the container with the cap spaced from and facing the tip of
the sampling needle;
actuating means for producing relative linear reciprocal movement
between the container and the sampling needle to cause the sampling
needle to pierce the cap and enter the fluid in the container and
thereafter be withdrawn from the cap;
the holder for the container being normally disposed at an angle to
the horizontal with the cap end of the holder upppermost and the
said actuating means being adapted to tilt the holder through the
horizontal before the sampling needle passes through the cap;
and
means being provided for venting the container through the cap
whereby the pressure in the cap is approximately equalized with
atmospheric pressure before the container is tilted into a
horizontal position.
5. Apparatus as claimed in claim 4, wherein the said means for
venting the container comprises a venting needle adapted to pierce
the cap before the sampling needle and enter an air bubble formed
above the fluid to vent the container.
6. Apparatus as claimed in claim 5, wherein the venting needle is
longer than the sampling needle and the venting needle is arranged
above the sampling needle and in parallel with the sampling
needle.
7. Apparatus as claimed in claim 4, wherein abutment means is
provided on the holder to retain the container in the holder when
the sampling needle is withdrawn.
8. Apparatus as claimed in claim 4, wherein the sampling needle is
mounted substantially rigidly in a connector which is adapted to
readily connect the sampling needle to a source of suction.
9. Apparatus as described in claim 5, wherein the sampling needle
and the venting needle are mounted substantially rigidly in a
connector which is adapted to readily connect the sampling needle
to a source of suction and to connect the venting needle to a
pressure source approximately equal to atmospheric pressure.
10. Apparatus as claimed in claim 9, wherein the sampling needle
and the venting needle are readily removable from the connector for
cleaning or replacement purposes.
11. Apparatus for withdrawing a fluid sample from a container which
is sealed by a cap formed from a material which can be readily
pierced by a sampling needle and which will reseal the aperture
formed by the sampling needle when the sampling needle is
withdrawn, comprising:
a housing;
a sampling needle mounted on the housing;
means for connecting the sampling needle to a suction source;
a holder for the container mounted on the housing and adapted to
hold the container with the cap spaced from and facing the tip of
the sampling needle;
actuating means for producing relative linear reciprocal movement
between the container and the sampling needle to cause the sampling
needle to pierce the cap and enter the fluid in the container and
thereafter be withdrawn from the cap;
the holder for the container being normally disposed at an angle to
the horizontal with the cap end of the holder uppermost and the
said actuating means being adapted to tilt the holder through the
horizontal before the sampling needle passes through the cap;
means being provided for venting the container through the cap
before the container is tilted into a horizontal position;
the means for venting the container comprising a venting needle
adapted to pierce the cap before the sampling needle and enter an
air bubble formed above the fluid to vent the container;
the venting needle being longer than the sampling needle and the
venting needle being arranged above the sampling needle and in
parallel with the sampling needle; and
the needles being mounted at the upper end of an inclined slideway
on the housing, the holder for the container is slidably mounted at
the lower end of the inclined slideway for reciprocal movement
toward and away from the needles, the slideway being pivotally
mounted at its upper end to the housing and the actuating means
being operable to pivot the slideway through the horizontal for
tilting movement of the container.
12. Apparatus for withdrawing a fluid sample from a container which
is sealed by a cap formed from a material which can be readily
pierced by a sampling needle and which will reseal the aperture
formed by the sampling needle when the sampling needle is
withdrawn, comprising:
a housing;
a sampling needle mounted on the housing;
means for connecting the sampling needle to a suction source;
a holder for the container mounted on the housing and adapted to
hold the container with the cap spaced from and facing the tip of
the sampling needle;
actuating means for producing relative linear reciprocal movement
between the container and the sampling needle to cause the sampling
needle to pierce the cap and enter the fluid in the container and
thereafter be withdrawn from the cap;
the holder for the container being normally disposed at an angle to
the horizontal with the cap end of the holder uppermost and the
said actuating means being adapted to tilt the holder through the
horizontal before the sampling needle passes through the cap;
the sampling needle being mounted substantially rigidly in a
connector which is adapted to readily connect the sampling needle
to a suction source; and
the sampling needle being readily removable from the connector for
cleaning or replacement purposes.
Description
SUMMARY OF THE INVENTION
The present invention relates to a method of and apparatus for
withdrawing a sample of fluid from a sealed container.
It is known to take a sample of blood from a vein by introducing a
needle into the vein and then applying an evacuated self-sealing
container to the outer end of the needle so that the vacuum in the
container draws a specific quanatity of blood from the vein into
the container. The container is then withdrawn from the outer end
of the needle and the cap on the container which is made from a
synthetic plastics material seals the hole left by the withdrawal
of the needle. A self-sealing container of this type is sold under
the Registered Trademark "VACUTAINER."
The blood sample is then contained in the sealed partially
evacutated container and testing procedures can only be carried out
on the sample by withdrawing small quantities of the fluid from the
container. Since it is normally desirable to carry out several
tests on one sample it is often necessary to withdraw several small
samples of blood from the sealed container. In the past, this has
been done by removing the sealed cap, placing a tube in the
container and withdrawing a small sample through the tube.
This method has the disadvantage that the cap has to be removed
from the container and may often be smeared with blood from the
container. In addition, the end of the tube which has been placed
in the blood may drip blood before it has been wiped clean. As a
result of both of these factors there is a risk of cross infection
occurring from the blood which is left on the cap or on the end of
the tube.
It is an object of the present invention to provide a method of
withdrawing samples of fluid from a sealed container without
removing the cap from the container and in a manner such that the
member used to withdraw the sample is automatically wiped as it is
withdrawn and the container resealed.
It is a further object of the present invention to provide a method
of removing fluid from a sealed container and apparatus therefor
such that the pressure in the sealed container is equalized with
the atmospheric pressure before the sample is withdrawn so as to
prevent any risk of too large a quantity of fluid being withdrawn
into pressure sensitive testing equipment.
According to one aspect of the present invention there is provided
a method of withdrawing a sample of fluid from a container which is
sealed by a cap formed from a material which can be readily pierced
by a sampling needle and which will reseal the aperture formed by
the sampling needle when the sampling needle is withdrawn,
comprising the steps of: inserting a sampling needle through the
cap and into the fluid in the container, withdrawing a sample of
fluid from the container by applying a negative pressure in the
sampling needle and withdrawing the sampling needle through the cap
allowing the cap to wipe the sampling needle as it is withdrawn and
thereafter reseal the container.
If the sample is being withdrawn from the container automatically
into a piece of testing apparatus and it is important to ensure
that the pressure in the container before the sample is withdrawn
is approximately equal to atmospheric pressure then the container
is vented through the cap before the sampling needle passes through
the cap.
The present invention also provides apparatus for withdrawing a
sample from a container which is sealed by a cap formed from a
material which can be readily pierced by a sampling needle and
which will reseal the aperture formed by the sampling needle when
the sampling needle is withdrawn comprising a housing, a sampline
needle mounted on the housing, means for connecting the sampling
needle to a source of negative pressure, a holder for the container
mounted on the housing and adapted to hold the container with the
cap spaced from and facing the tip of the sampling needle and
manually or automatically operable actuating means for producing
relative linear reciprocal movement between the container and the
sampling needle to cause the sampling needle to pierce the cap and
enter the fluid in the container and thereafter be withdrawn from
the cap.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a longitudinal section through a connector of the present
invention.
FIG. 2 is an end view of the connector of FIG. 1.
FIG. 3 is an elevation, partly in section of an applicator for
applying the connector of FIGS. 1 and 2 to a fluid container in the
withdrawn position.
FIG. 4 is an elevation similar to FIG. 3 but showing the applicator
in the forward position.
FIG. 5 is a plan view of the applicator in the forward
position.
FIG. 6 is a view similar to FIGS. 3 and 4, but showing the
applicator in an intermediate position.
DESCRIPTION OF THE INVENTION
In the drawings, a connector is indicated generally at 10 which is
adapted to connect a withdrawal tube 11 to the fluid in a container
12 so that a measured quantity of the fluid can be withdrawn from
the container through the tube 11.
The connector 10, which is shown in detail in FIGS. 1 and 2,
comprises a main body 13, a needle holder 14 which carries two
needles 15 and 16, a threaded cap 17 which secures the needle
holder 14 to the main body 13 and a threaded pin 18.
The main body 13 of the connector has a threaded boss 19 at one end
and an internally threaded, axial recess 20 at its other end. The
end face of the boss 19 is formed with a central frustoconical
recess 21 and with an annular groove 22 which surrounds the recess
21. An axial bore 23 communicates between the recess 21 in the end
face of the boss and the axial recess 20 in the other end of boss.
A conduit 24, which communicates between the groove 22 and the
atmosphere forms an air vent to the groove 22 and extends through
the main body 13 at an angle to the axis of the connector.
The needle holder 14 is cylindrical and has a collar 25 at one end
forming an abutment which seats in the cap 17. The needles 15 and
16 are mounted in bores which extend through the holder 14 and are
fixed in place by soldering or any other suitable means. The needle
16 is mounted on the axis of the holder 14 and a portion 16a
projects a short distance outwardly from the rear face of the
holder whereas the needle 15 is offset from the axis and terminates
flush with the rear face of the holder 14. Both of the needles 15
and 16 are hollow and sharply pointed and the needle 15, which is
offset from the axis of the holder, is substantially longer than
the needle 16.
In order to attach the needle holder 14 to the main body 13, the
holder 14 is positioned against the end face of the boss 19 with a
pin 26, which projects forwardly from the end face of the boss,
located in a hole 27 formed in the collar 25 and the portion 16a
located in the recess 21 and surrounded by an O-ring seal 28 which
is housed in the recess 21. The location of the pin 26 in the hole
27 ensures that the longer needle 15 is angularly aligned with a
radially projecting pin 29 on the main body 13, the purpose of
which is explained below. When the holder 14 is positioned against
the end face of the boss 19 the cap 17 is threaded home to secure
the holder 14 on the boss and it will be seen from FIG. 1 that,
when assembled, the needle 15 communicates through the groove 22
and conduit 24 with a tube 72. The tube 72 leads to a vessel 74
which is closed by a lid 76 and which contains a small quantity of
antiseptic fluid. The tube 72 passes through the lid 76, which is
readily removable from the vessel. It will be noted that the volume
of the vessel 74 is substantially greater than the volume of the
container 12.
The pin 18, which is threadedly mounted in the recess 20 retains an
O-ring seal 30 at the end of the recess and is formed with a
stepped through bore 31 forming a continuation of the axial bore 23
is the main body. The withdrawal tube 11 is a slide fit through the
bore 31 and the O-ring seal 30 into the axial bore 23 when the pin
18 is unscrewed and is clamped in position by the O-ring seal 30
when the pin 18 is tightened home on to the O-ring seal.
In order to connect the tube 11 with the fluid in the container 12
to enable a quantity of the fluid to be withdrawn from the
container, the container and the connector are mounted on an
applicator which is indicated generally at 40 in FIGS. 3 to 5.
The applicator 40 comprises a channel shaped housing 41 having side
walls 42 and 43. The housing 41 is mounted on a support 44 so that
it is inclined to the horizontal at an angle of approximately
30.degree. with its forward end 45 substantially higher than its
trailing end 46. Pivotally mounted at 62 between the side walls 42
and 43, at the forward end 45 of the housing is a cross-bar 47
which is adapted to receive the connector 10. A clamp 48 is hinged
to the cross-bar 47 and a screw 49 is provided to tighten the clamp
48 so as to firmly mount the connector on the cross-bar. The clamp
48 is provided with a hole which is adapted to receive the pin 29
on the main body 13 of the connector to ensure that the needle 15
is located vertically above the needle 16.
Two parallel rods 50 project rearwardly from the cross-bar 47 and
are slidable engaged through two bores formed in a mount 51. The
rear end of the mount 51 is pivotally linked at 63 to the lower end
of a handle 52 which is pivotally mounted at 64 between upwardly
projecting extensions 53 and 54 of the side walls 42 and 43
respectively.
The mount 51 is formed with an upwardly opening recess 55 adapted
to receive the container 12. The contaienr 12 is not a close fit in
the recess 55 and a gap is formed between a forward end wall 56 of
the mount and the end face of the cap on the container. The extent
of this cap will depend upon the length of the container and the
length of the container cap.
An aperture 58 is formed in the end wall 56 and as can be seen from
FIGS. 3 to 6, the size and position of the aperture 58 is such that
the needles 15 and 16 can pass through the aperture and into the
container 12.
When the connector 10 and the container 12 are mounted on the
applicator 40, as shown in FIG. 3, the tip of the upper, longer
needle 15 is located partly in the aperture 58 but spaced from the
container 12.
In order to actuate the applicator, the handle 52 is depressed and
the rods 50 and mount 51, which is carrying the container 12 are
pivoted upwardly about the pivot point 62. At the same time, an
elbow 52a at the bottom end of the handle drives the mount
forwardly along the rods 50 towards the needles 15 and 16.
The container 12 is provided with a known self-sealing cap 60,
which can for example be formed from a butyl rubber material. As
the mount and container are initially moved forwardly the container
is held with the cap uppermost and with the air bubble adjacent the
cap so that the needle 15 pierces the cap 60 and enters the air
bubble. This position is shown in FIG. 6. The needle 15
communicates through a tube 72 with interior of the vessel 74,
which is kept approximately at atmospheric pressure. Since the
volume of the air bubble in the container 12 is substantially less
than the volume of the vessel 74, the air pressure in the container
will be immediately equalized approximately with atmospheric
pressure.
As the container and the mount continue to move forwardly the
shorter needle 16 pierces the cap 60 and the container is tilted
through the horizontal so that the air bubble moves away from the
cap 60 and the needle 16 pierces the cap, and enters the fluid
which is now adjacent the cap, the air bubble having risen to the
opposite end of the container. This condition is shown in FIG.
4.
When the handle 52 is fully depressed, a negative pressure is
applied to the tube 11 so as to withdraw a determined quantity of
fluid from the container. When the sample has been withdrawn from
the container, the handle 52 is raised so as to withdraw the
container from the connector. As the needles 15 and 16 are
withdrawn, the container is lowered through the horizontal so that
the air bubble in the container moves along the container towards
the cap. The needle 15 is withdrawn immediately before the air
bubble reaches the cap but the needle 16 is withdrawn through the
air bubble so that pressure in the container is again equalized
approximately with atmospheric pressure.
As the mount 51 and the container are drawn away from the needles
the friction exerted on the needles by the cap initially holds the
container and the cap in position until such time as the end wall
56 of the mount engages the outer face of the cap and draws the
container and the cap away from the needles. As the needles are
withdrawn through the cap they are wiped substantially clean and
the cap then reseals the container. The container can then be
removed from the applicator until a further sample is required.
Under some operating conditions, fluid from the container 12 has
been found to creep back along the needle 15. The reason for this
is not yet known. If this occurs, the fluid will pass along the
tube 72 into the vessel 74 where it drips into the antiseptic
fluid. The lid of the vessel 74 can be readily removed to replace
the antiseptic fluid and also to ensure that the pressure in the
vessel 74 is kept approximately at atmospheric pressure.
If the problem of creep back along the needle 15 should not occur
then the needle 15 can communicate directly with the atmosphere via
the groove 22 and conduit 24.
The connector 10 and applicator 40 enable a sample to be withdrawn
from the container 12 without any substantial spillage of fluid
from the container. The cap 60 remains on the container throughout
the operation and the needles which enter the fluid are
automatically wiped as they are withdrawn through the cap. The tube
11, which may form a permanent part of a piece of testing apparatus
does not enter the container and can be removed from the connector
clean, thus eliminating the need for wiping.
The connector 10 and the applicator 40 also ensure that the
pressure in the sealed container 12 is approximately equal to
atmospheric pressure before any fluid is withdrawn through the tube
11. This is particularly important if the tube 11 is connected to
apparatus, such as a Coulter counter, which is an automatic blood
count apparatus and which is sensitive to pressure differences in
the container. Many pieces of testing equipment of this kind apply
a negative pressure to the container to draw off a measured
quantity of fluid and are set to work against atmospheric pressure.
Consequently if there is a vacuum in the container the quantity of
fluid drawn into the testing equimpment will vary. This problem
does not arise if a sample is drawn from an open container but if a
sealed container is used then a pressure is normally created
whenever liquid is withdrawn through the cap and also whenever the
cap is removed and then replaced.
The applicator 40, by tilting the container 12 throuh the
horizontal also enables substantially all of the fluid to be
withdrawn from a container by the shorter needle so that none of
the sample in a container need be wasted.
It will be appreciated that the use of the second needle 15 to
equalize the pressure in the container is only essential if the
fluid is bein withdrawn into apparatus that is sensitive to
pressure differences in the container and if this is not the case
then the second air venting needle can be omitted.
It will also be understood that it is within the scope of the
present invention to provide a switch mechanism on the applicator
40 which automatically actuates apparatus connected to the tube 11
when the handle 52 is fully depressed. Additionally, it will be
understood that the applicator 40 can itself be automatically
operated and that other modifications can be made both to the
applicator 40 and the connector 10 without departing from the
spirit and scope of the present invention.
* * * * *