Note: Descriptions are shown in the official language in which they were submitted.
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METHOD AND APPARATUS FOR COLLECTING BLOOD
RELATED APPLICATIONS
This invention disclosure is related to and claims the benefit
of filing dates of the following United States Provisional Patent
Applications: (1) Serial No. 60/042,978, entitled METHOD AND
APPARATUS FOR REGULATING SPECIMEN FLOW TO A
COLLECTION CONTAINER, filed April 8, 1997, (2) Serial No.
60 / 055,517, entitled IMPROVED METHOD AND APPARATUS FOR
COLLECTING BLOOD, filed August 13, 1997, and (3) Serial No.
60/062,292, entitled IMPROVED METHOD AND APPARATUS FOR
COLLECTING BLOOD, filed October 17,1997.
FIELD OF THE INVENTION
The present invention relates generally to a method and
apparatus for the collection of blood specimens, and more
particularly to a blood collection apparatus which diverts, channels,
regulates, diffuses or controls fluid or specimen flow to a collection
container to reduce the occurrence of hemolysis, reduces the
probability of collapsing the blood vessel during the specimen
drawing procedure, minimizes container breakage during
manufacture, use and testing, improves vacuum retention in a
sealed container, allows a specimen to be placed on a slide directly
from a closed collection container without using a needle, or by a
blunt tipped needle, and an improved blood collection needle with a
manually activated needle guard.
BACKGROUND OF THE INVENTION
The collection and analysis of blood is one of the most
commonly used procedures in the diagnosis of many illnesses and
diseases. Blood, the essential element to human, as well as animal
and marine existence, consists primarily of red blood cells, which
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usually range from 6-8 ~. (microns) in size; white blood cells,
normally being from 10-14~. in size, but sometimes reaching 19-20~
in size; with additional proteins and antibodies.
The dynamics involved in collecting blood involve a number
of variables and the present invention addresses these both
individually and in combination, allowing a more accurate, viable
sample to be safely obtained.
Blood is made up of particulate cell forms suspended in a
fluid medium called plasma. The blood is contained within a closed
system of pumps, passageways, chambers and valves which make up
the circulatory system. Blood consists mostly of red cells and plasma,
45% and 55% respectively by volume, with the gaseous carrying red
cells being suspended in the fluid plasma. The blood is pumped
throughout the circulatory system by the heart, and kept in a fluid
suspension medium in the blood vessels. Blood cells are actually
tiny, delicate living cells which must be maintained in a chemically
balanced fluid environment in order to survive and properly
function.
Potassium, one of a number of inorganic substances needed to
maintain a healthy metabolism, is the major cation of the
intracellular \fluid in red cells. The average cellular concentration
of potassium in red cells is 105 mmol/1, or approximately 23 times
greater than that of the average serum potassium level.
Additionally, the permeability of cell membranes for potassium is
extremely low, so rapid shifts of potassium in or out of cell
membranes by diffusion are unlikely. Hemolyzed blood results in
elevated serum potassium levels because the intracellular potassium
is released from the ruptured red cells into the serum. Thus,
hemolysis invalidates measured serum potassium levels.
Figure 1 illustrates a cross-sectional and full view of a prior art
blood collection device 10 that is used to withdraw a blood, bodily
fluid or gas specimen from a patient. The prior art blood collection
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device has three primary components. These include: (1) a hollow
container or vacuum tube 140, sealed by a puncturable diaphragm or
stopper 141, for obtaining a fluid or gaseous sample; (2) a separate
holder 130 which accepts and temporarily holds the evacuated
container; and (3) a hollow bore hypodermic needle 121 having a
lumen 124 therethrough and a sharpened distal tip distal 120 and
sharpened proximal tip 123.
Needle 121 is attached to holder 130 with the proximal
sharpened tip 123 residing in the interior of holder 130 and
sharpened tip 120 extending away from holder 130. Proximal end of
needle 121 typically includes a piercable resilient cover 125.
Container 140, having an open end and closed end, and internal
chamber 143 with removable sealing plug 141 placed in the open end
of tube 140. Blood is drawn from a patient by first inserting the
sharpened distal tip 120 of needle 121 into the blood vessel of the
patient. Cover 125 inhibits the flow of blood from the proximal end
of needle 121. Vacuum tube 140 is then positioned within hollow
body 135 of holder 130 and slid forward in holder 130 (indicated by
arrow M) allowing proximal end 123 of needle 121 to puncture
sealing plug 141 of vacuum tube 140. The specimen fills the
collection container 140 and then is removed from the needle holder
130.
The pressure difference between the patient's blood flowing in
the blood vessel and the negative pressure in the vacuum chamber
causes blood to be rapidly drawn into internal chamber 143 of
vacuum tube 140.
Figure 28 is a cross sectional view of a prior art needle 121
having a jagged inner wall 111.
Figure 42 is a prior art collection container 140 having a
chamber 143 sealed by a sealing plug or puncturable diaphragm 141.
The present invention addresses each aspect associated with
the collection of venous or arterial blood and improves on each
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individual component: the needle; the needle holder; the collection .
container; the sealing plug or diaphragm; the sealing plug shield;
and a collection adapter.
The present invention comprises a number of embodiments
related to blood collection including a simple, one-piece flow
diverting sealing plug, shown in Figures 3-10, whereby the specimen
is "cushioned" in a fluid medium as it is collected through a hollow
bore needle and fills collection container, rather than subjecting the
blood to high impact and shear forces inherent in standard blood
collecting equipment and procedures.
Another one piece sealing plug, described in Figures 11-15 and
30, impedes the specimen flow prior to entering a collection
container; a two piece sealing plug and flow controlling portion, are
disclosed in Figures 16-19, where the specimen first enters an
intermediate or inner chambers) prior to entering a collection
container; an adjustable flow rate sealing plug having a diverter
shown in Figures 24-27, allowing the user to easily start, stop or vary
the specimen flow rate during the collection procedure.
A one piece sealing plug, described in Figures 20-23, discloses a
reed valve means to control specimen flow through the sealing
plug. Another one piece sealing plug, described in Figure 32,
discloses a permeable or pre-pierced membrane to regulate or divert
specimen flow through the sealing plug. Another one piece, multi-
chambered sealing plug, shown in Figure 33, comprises a chamber
and recess or chamber to divert the specimen flow through the
sealing plug.
The needle is addressed in Figure 29, having a friction
reducing coated inner wall, or the needle itself can be manufactured
to smooth the jagged, rough inner surface produced by the current
manufacturing processes when drawing metal tubing to size. These -
improvements are designed to reduce the high shear forces placed
on the blood as it is sucked through the needle lumen. An
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increasing diameter needle, shown in Figure 31, can be used with
either the conventional sealing plug or any of the other sealing
plugs described herein.
Figure 30 describes a penetration-related adjustable flow blood
collection system where the specimen flow is controlled by
rotational movement of a container relative to needle holder.
A two component flow diverting sealing plug and shield,
which isolates blood or bodily fluids from the phlebotomist or
healthcare worker during blood collection procedures, is shown in
Figures 34, 35, 40 and 41, with sealing plug with a chamber and
covering shield having the chamber manufactured in a pre-
determined position whereby needle tip penetrates only into the
chamber, and not directly into the internal chamber of the collection
container.
Another two component sealing plug and diverter, shown in
Figures 47 and 48, has a means to divert the specimen radially
towards the perimeter of a collection container as it exits needle
lumen within the chamber, sealing plug and diverter allow
specimen to enter the internal chamber of a collection container at
the lower extremity, regardless of how the collection container is
positioned in needle holder, where specimen can fill into itself, thus
cushioning entry into the collection container. Separate
components of these sealing plugs are shown in Figures 49-52,
although a multitude of configurations may also achieve the same,
or similar, result.
The two component sealing plug and diverter, shown in
Figures 47 and 48 could also be manufactured as a single component
to achieve a similar desired result.
Another two piece sealing plug and diverter, shown in
Figures 38 and 39, discloses a lower cost, reduced mass sealing plug
and a diverting means to fill the container with specimen beginning
at the sealing cap and filling to the opposite end of the container.
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The blood collection needle punctures the sealing plug
concentrically and the specimen flows through the concentrically
positioned diverter. A longer needle typically used to draw collected
specimen from the collection container may by-pass the diverter by
being inserted away from the center of the sealing plug. The sealing
plug does not have to be removed to withdraw a specimen from the
collection container.
A sealing plug with a reducing chamber is shown in Figure 36
which regulates and diverts the specimen flow from a needle to a
container. The reducing section also slows the specimen flow to
reduce vein collapse probability during the collection process. A
sealing plug, shown in Figure 37, has a filtering means within, in or
adjacent to a sealing plug or container; an adjustable depth
penetration sealing plug with shield, shown in Figures 40 and 41,
allow the user to easily start, stop or vary the specimen flow rate
with a control means limiting the longitudinal movement of
collection container towards needle, yet an unrestricted withdrawal
of container from needle holder. The shield is included, but not
necessary to practice this embodiment of the invention.
Container, shown in Figures 43 and 44, has a coating or film
about the outside glass or plastic surface of container, reducing the
probability of container breakage in the event the container is
dropped or crushed during manufacturing, storage or use; container,
shown in Figure 45, has a coating, film or label about the intersection
of the sealing plug and container, reducing the probability of
vacuum leakage from within chamber.
Another two component sealing plug and sensor, shown in
Figure 46, has a sensor or probe which allows analysis of specimen
without removal from the collection container.
An automatically shielding sealing plug and shield are
described in Figures 53 and 54 where sealing plug is slidable relative
to a shield. The container has a greater gripping force on the shield
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whereby axial movement of the sealing plug occurs first and
projection of the shield engages the sealing plug during removal
with the sliding shield closing the port at an intersection.
A flow indicator or viewing section is shown in Figure 55
allowing user to observe specimen flow in the chamber of the
sealing plug. A collection container having round ends for inserting
either end into a centrifuge is shown in Figure 56. A coupling
device is shown in Figure 57 which allows a smaller pediatric needle
holder, shown in Figure 59, to be used with a standard, or larger
collection container. The use of a smaller diameter device allows a
shallow angle to be used for easier access of a blood vessel during
blood collection procedures.
A coupling device having a flow regulating or diverting plug
is shown in Figure 58, coupling device or extension allows a smaller
pediatric needle holder to be used with a larger collection container.
A new collection container having two piercable ends which can be
used with both small and large needle holders is shown in Figure 59.
Larger end of collection container having a rounded contour for
insertion into a centrifuge. Both sealing plugs comprise chambers,
for diverting specimen flow prior to entry into collection container.
A one piece sealing plug with venting means is shown in
Figures 6I-63 to equalize the internal pressure within a collection
container with the ambient atmospheric pressure prior to full
removal of the sealing plug from a collection container.
A sealing plug with a chamber having external access is
shown in Figures 64 and 65. A removable cover or seal allows the
specimen deposited in the chamber to be placed on a slide without
using a needle to access the specimen in the container.
A sealing plug with a chamber having external access and a
movable shield with an aperture is shown in Figures 66-69. The
movable shield allows the specimen deposited in the chamber to be
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placed on a slide without using a needle to access the specimen in
the container.
The present invention also comprises a simple, two-piece
flow diffusing sealing plug, shown in Figures 70 and 71, whereby the
specimen is "diffused" in a porous medium as it exits the hollow
bore needle prior to filling a collection container. Another simple,
two-piece flow diverting sealing plug, is shown in Figures 72 and 73,
whereby the specimen is diverted through an aperture during the
collection process. An expandable material creating the aperture is
activated by a contact with a liquid and swells to close the aperture
within minutes of becoming wetted.
A two-piece sealing plug which adds a single diverting
component to an existing prior art sealing plug or the like is shown
in Figure 74. The diverting component may also include a
supporting means to keep the sealing plug wall from collapsing or
moving when positioned in the tube, thus improving vacuum
retention inside the tube by maintaining a proper seal between a
sealing plug and tube. A compressive, radial force is exerted on the
elastomeric sealing plug wall by the inner support or diverting
component. The distal diverter wall section between the chamber
created within the sealing plug and collection container is positioned
far enough away from the blood collection needle so the needle does
not puncture the wall section when a specimen is collected. The
distal diverter wall section may be puncturable by a longer needle
which safely draws out the collected specimen from the container
during testing and analysis without removing the sealing plug. The
diverting wall section may also include a dissolvable or separable
material. The separable wall section would be sufficiently held in
place during the collection process, and removed by the centrifugal
forces created when the collection container is centrifuged.
Another two-piece sealing plug with a supporting means to
keep the sealing plug wall from collapsing or moving when
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positioned in the tube is shown in Figure 75. This invention
improves vacuum retention inside the tube by maintaining a proper
seal between a sealing plug and container wall.
A two-piece sealing plug is shown in Figures 76 and 77
included a diverting component which is activated when a pressure
difference is created between the intermediate chamber of the sealing
plug and the internal chamber of the collection tube. A valve opens
when a specimen is drawn into the chambers, and closes when the
pressure in the chambers is substantially equal.
A sealing plug with a diverting component with a channel or
slot is shown in Figures 78 and 79. The specimen is collected
through the diverter which is concentrically positioned to accept a
puncturing blood collection needle. A channel is eccentrically
positioned to allow a long needle to be inserted into the collected
specimen without contacting any specimen which may remain in
the intermediate chamber of the sealing plug and diverter after the
specimen is collected.
A blood collection needle is shown in Figure 80 with a needle
guard and a positive stop to keep the needle guard adjacent to the
needle hub during the blood collection procedure. A compressive
force exerted on a finger pad or button selectively releases the needle
guard from a retained position to a protecting position where the
sharp needle tip is safely covered when the user so desires.
There are no known blood collecting devices which take the
delicate physical nature of living blood cells into consideration
during the collection process as thoroughly and comprehensively as
the present invention does.
Standard blood collection vacuum tubes are popular for
everyday blood drawing procedures, with a variety of additives such
as anti-clotting agents, clotting agents, wax, reagents or the like
included in the evacuated chamber to facilitate the examination of
the blood specimen. Basically, all standard, single chambered
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vacuum tubes are designed to draw fluids or gaseous substances into
the evacuated chamber at a rapid, uncontrolled rate. Single
chambered vacuum tubes comprise a single negative pressure in a .
chamber 143, which causes a rapid suction of fluids or gaseous
substances to be drawn through a small, hollow bore needle lumen
124 and into evacuated chamber 143 when sealing plug 141 is
punctured by the needle. The manner in which a specimen is drawn
into chamber 143 causes high forces to act on the delicate blood cells.
Since the introduction of evacuated blood collection
containers, widely known as the VACUTAINERO brand blood
collection system, described in Figure 1, improvements have been
limited to sharper needles, new additives for inside the collection
container, tubes made of plastic resin to reduce container breakage,
and vacuum retention to improve shelf life of the collection tube.
There are major limitations inherent to the use of standard,
single chambered blood collection vacuum tubes. First, the
unrestricted, high velocity flow rate of the specimen through the
hollow bore needle into the evacuated chamber launches the
specimen into an empty chamber on a collision course with the far
wall of container, causing physical damage to the blood cells, or even
cell membrane rupture, which is also known as hemolysis.
Secondly, the unrestricted suction pressure of vacuum tube often
results in the collapse of the patient's blood vessel, which then
requires the use of a syringe to obtain the specimen.
The pressure difference between the existing blood pressure of
the patient and the sub-atmospheric pressure in the evacuated
collection container determines the velocity and flow rate of the
specimen entering the container. The sub-atmospheric pressure in
evacuated chamber is greatest when the sealing plug is initially
punctured by the needle. The specimen is uncontrollably projected -
at a high velocity through the empty chamber, impacting the far wall
of container.
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Furthermore, standard blood collection equipment and
procedures place the delicate blood specimen in a very precarious
environment, creating high shear forces as the specimen is sucked
through and exits the small, hollow bore needle. The shear forces
may hemolyze the blood cells. The velocity and momentum of the
specimen entering the vacuum container causes it to be launched
across an empty chamber and into the hard, unforgiving far wall of
the collection container. The flow velocity of the specimen entering
the container is great enough to injure and rupture many red cells as
they impact the container wall, causing hemolysis. Many of the
blood cells which initially survive the impact with the far wall of the
container intact may be injured due to the serious blunt force
trauma imposed on the cells.
Of course, the main objective of collecting the specimen is to
determine the health of the patient. This is best accomplished by
keeping the blood specimen intact, and in the most viable condition
possible, in other words, alive and living.
During analysis, some specimens are found to be so damaged
and grossly hemolyzed during the collection process, that the
laboratory issues a disclaimer and orders another blood sample taken
from the patient for analysis. The re-drawing of a specimen creates
an additional, unnecessary cost for the medical institution and
requires the patient to be punctured with a needle a second or third
time.
In the history of blood collection, few attempts have been
made to prevent hemolysis from occurring during the collection
process. The majority of hemolysis related prior art simply makes
adjustments to the test results, essentially compensating for the
damage inflicted on the specimen during the collection process.
This "after the fact" procedure further complicates analysis and is at
best a speculative attempt to determine the health of the specimen,
and patient.
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The most notable attempt to prevent hemolysis during the
collection process is taught by Villa-Real in U.S. Patent #4,492,634
where a sealing plug with a baffle extension simply deflects the high
velocity stream of blood into the side wall of the collection tube.
This deflection causes the fragile blood cells to impact the hard side
wall of the tube. The apparatus of Villa-Real also generates
additional turbulence within the collection tube.
An earlier valvular device is also taught by Villa-Real in U.S.
Patent #3,848,579, which attempts to control the flow of blood
passing through the hollow bore hypodermic needle. This apparatus
draws blood through a small hollow bore needle into a larger
diameter chamber housing a reed valve, again reducing to a hollow
bore needle and exiting into a collection tube. One problem also
created with the apparatus of Villa-Real is that the opening and
closing of the valve causes additional turbulence and forces to act
upon the delicate living blood cells during the collection process.
After passing through the valve, the specimen flow path is again
reduced. Additional components are also needed to fabricate this
invention, increasing the cost.
The rate at which blood is drawn from a blood vessel is
determined by the volume of blood in the vessel, the pressure
difference between the internal pressure of blood vessel and the sub-
atmospheric pressure in the collection vacuum tube, and the
internal diameter size of the needle lumen. For instance, a common
21G blood collection needle has an inside diameter of approximately
.028", which allows an evacuated tube to be filled in only a few
seconds.
Another problem which regularly presents itself during the
collection process is blood vessel collapse. The volumetric capacity
of the blood vessel in certain patients is inadequate to self-replenish
when blood is rapidly collected into a standard collection container.
This problem is typical with young, older or anxious patients.
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The inadequate replenishment of blood causes the blood
vessel to collapse, interfering with the blood collection procedure
and forcing the phlebotomist to use a standard, sterile syringe and
hypodermic needle to collect the blood sample. The syringe permits
a manually operated suction to be applied to the blood vessel, thus
enabling the healthcare worker to collect the blood sample at a rate
that usually is slow enough to keep the vessel from collapsing.
Routinely, when a syringe is used to collect a blood specimen
in a patient whose vessels are prone to collapse, the patient's blood
vessels must be punctured a number of times to collect enough
blood specimen for analysis. Multiple punctures are painful to the
patient and can take an extra 5 to 15 minutes to complete. The
healthcare worker may also become anxious because of the inability
to collect the needed specimen in an allotted time without undue
discomfort to the patient. The collected blood specimen must be
then transferred into an evacuated tube for storage and testing.
Conversely, another problem occurs when the vacuum
within the collection container diminishes or leaks over time,
reducing the shelf-life of evacuated tubes. This results from an
improper seal at the sealing plug/container surface interface. The
seal is discontinuous because of the uneven surface inherent to
molded or compression molded elastomeric materials. Small voids
in the sealing plug or stopper surface allow the seal to be breached by
the ambient atmosphere and the vacuum within the container is
lost over time. Areas where the seal is discontinuous is known in
the industry as "gray band" regions. Elastomeric materials are
known to be susceptible to temperature fluxuations and typically
contract over the course of time.
Vacuum leakage was so prevalent when evacuated collection
containers were first introduced that the evacuated collection tubes
were packaged in sealed shipping containers which also had been
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evacuated. The user would open the shipping container releasing
the vacuum inside the container and then use the collection tubes.
Collection containers with reduced vacuum do not provide a
sufficient amount of specimen needed for analysis and are normally
disposed of as medical waste. Another tube must then be used to
collect an adequate amount of specimen for analysis. Despite the
attempts to minimize vacuum leakage in containers through
computer generated sealing plugs and the use of different materials,
vacuum loss still remains a problem.
The present invention provides an improved sealing means
at the sealing plug/container surface interface. The improved
sealing means invention can be used with prior art sealing plugs or
with the flow diverting, regulating or diffusing sealing plugs
disclosed in this application.
A blood specimen is normally prepared for analysis either of
two ways, depending on the nature of the test to be performed. If the
serum is to be analyzed, the elements of red cells and plasma remain
combined as whole blood serum. The specimen is allowed to clot
and retract overnight before being decanted and analyzed.
If the plasma or red cells are to be analyzed individually, they
are spun in a centrifuge to separate the red cells from the plasma.
Additives are normally included in the collection container to delay
clotting.
The present invention also includes a flow diverting sealing
plug with a liquid activated material surrounding an aperture which
is in the fluid path. The blood is collected and within minutes, the
liquid activated material swells closing the aperture. The closed
aperture prevents any specimen remaining in the sealing plug from
combining with the specimen in the collection container after the
collection process is completed.
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Another test, the complete blood count (CBC) test is
performed on whole blood immediately after the specimen is
collected.
Blood which is collected with a syringe must be transferred to
an evacuated tube prior to analysis or centrifuging. Transferring the
collected specimen from a hypodermic syringe to an evacuated tube
is considered the most dangerous blood transferring procedure in
medicine today because the healthcare worker must move the
exposed needle containing blood directly towards the hand holding
the evacuated tube. One small miscalculation and the healthcare
worker receives a direct inoculation of the specimen blood contained
in the needle lumen.
If a needle stick occurs during the transfer of blood contained
in the syringe and needle to a vacuum tube, and the blood specimen
contains a blood borne pathogen such as of Human
Immunodeficiency virus (HIV), Hepatitis C (HCV) or any of the
other twenty-odd blood borne pathogens which are transmitted by
blood, the healthcare worker may become infected by that pathogen.
Bacterial pathogens such as Yersinia enterocolitica and
Pseudomonas fluorenscens have recently been identified in collected
blood, further threatening the well being of healthcare workers if a
needle stick occurs and the bacteria is present in the blood.
If the healthcare worker forcibly transfers the specimen from
the syringe into the vacuum tube, over pressurizing the vacuum
tube may cause the sealing plug to dislodge from the vacuum tube
and spray the collected blood into the workplace.
Two posters highlighting the problem of transferring the
blood collected in a syringe into a vacuum tube were presented at the
August 1995 Centers for Disease Control conference on preventing
needle sticks. One alternative solution to the problem is taught in
U.S. Patent #5,439,450, where the blood is collected in a user-
activated l0cc sliding sleeve syringe. This rather large size syringe
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has a sliding sleeve with a diameter sufficient to insert the evacuated
tube into the extended sliding sleeve thereby isolating the needle
from the healthcare workers' hands during the transfer from the
syringe.
The standard blood collection system may work adequately in
instances where patients' blood vessels have the capacity to quickly
replace the blood volume being removed and collected. However,
approximately five percent of blood collections must be
accomplished with a manually activated syringe. This translates
into approximately 150 million blood collection specimen
procedures with a syringe per year.
Essentially, blood cells are living, microscopic "liquid
balloons" containing liquid in a permeable membrane, which may
be injured, or even rupture, when exposed to excessive force. The
membrane may also break as a result of being torn or otherwise
traumatized. Hemolysis of red blood cells is one problem that may
result from the over traumatization of the blood sample.
In addition to hemolysis of red blood cells, vacuum drawing
may result in other abnormalities which tend to confound
interpretation of data relying on visual examination of cells. The
appearance of cell abnormalities or cell fragments, which may be
regarded as an indication of illness, may actually comprise artifact
caused in the vacuum drawing process. For instance, red blood cell
abnormalities such as clumping or stacking, which may otherwise be
indicative of disease, may in actuality be caused by the blood drawing
process, and not the disease. A more optimal sample of blood can be
obtained if the blood collection procedure can be accomplished
without creating unnecessary trauma to the blood cells in the
sample, the circulatory system or the patient.
Figure 2 shows a blood specimen being introduced into the
internal cavity 143 of the blood collection container 140 of Figure 1.
As illustrated, once the distal end 123 of the needle 121 pierces the
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collection container sealing plug 141, the blood specimen rushes into
the evacuated cavity 143. Initially, the blood specimen impinges the
collection container wall at a high velocity. The high velocity
impact of the blood specimen against the internal walls of cavity 143
traumatizes the blood specimen causing hemolysis and other
undesirable physical changes to occur within the specimen.
Even as the evacuated cavity 143 fills, the specimen continues
to enter the tube 140 at a high velocity causing an inner fluid and
gaseous turbulence within the cavity 143.
It is also important to note that a small amount, or smear, of
blood is normally placed on a slide during the collection process.
The slide specimen is used to determine the percentage of white cells
per 100 blood cells, or the complete blood count (CBC) by means of a
visual test. The CBC test can be conducted manually, or in an
automated fashion, where a laser is directed on the specimen and
the cell count is determined by the way the laser bounces off the
different cells.
The smear is obtained by removing the blood collecting
apparatus from the venipuncture site with a needle exposed by
pressing the filled collection container against the needle holder,
forcing a small amount of blood through the needle and onto a slide.
Sometimes the needle used to directly access the blood vessel is
disposed of and a new needle is placed on the needle holder whereby
a filled collection container is pressed in the needle holder to obtain
a smear for a slide.
If the needle is withdrawn from the venipuncture site
covered, a new needle must be used to obtain a smear for a slide.
The use of another needle to obtain a smear for a slide adds cost and
exposes the healthcare worker to another sharp needle containing
blood.
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What is needed is an apparatus and method for collecting a
specimen sample, such as blood or other bodily fluids or gases into a
collection container that solves the aforementioned problems.
SUMMARY OF THE INVENTION
The foregoing objects have been achieved by the specimen
collecting apparatus of the present invention capable of regulating,
restricting, controlling, diverting or varying the flow of a specimen
within or into a collection container, evacuated container or syringe.
The present invention provides an improved apparatus and
method for delivering a specimen sample into a collection
container.
In one embodiment, a specimen collection apparatus is
provided having a flow diverting or regulating means which diverts
or regulates the flow of a specimen into or within a specimen
collection container.
In one embodiment, a specimen collection apparatus is
provided with a needle or other fluid communication means,
having an occluded or restricted lumen that regulates the flow rate
of a specimen into a specimen collection container.
In another embodiment, a hypodermic needle, or other
fluid/gas communication means, is provided having a lumen bore
that is coated with a friction reducing material, such as silicone.
In yet another embodiment, a hypodermic needle, or other
fluid/gas communication means, is provided having a lumen bore
that is coated with a anti-clotting material, such as heparin.
In yet another embodiment, the vacuum tube sealing plug is
provided having a flow diverting or regulating means that diverts
or regulates the flow into and/or within a collection container. The
sealing plug contains a least one opening, channel, cavity, area or
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passageway which diverts or regulates the specimen flow through
the sealing plug from a needle into the collection container. The
flow diverting or regulating opening, channel, cavity, area or
passageway is in direct communication with the internal cavity of
collection container. The flow diverting or regulating opening,
channel, cavity, area or passageway can also be coated with a friction
reducing material, anti-clotting material or the like used in the
analysis of blood.
In yet another embodiment, the sealing plug is provided
having a flow diverting or regulating means that diverts or regulates
the flow through, into or within the sealing plug itself. The sealing
plug is provided with at least one chamber, which can be an internal,
open, intermediate or inner chamber, that diverts or regulates the
specimen flow into and/or within the collection container. Blood,
or other bodily fluids or gases, is introduced into the chamber of the
sealing plug before being directed into the internal cavity of the
collection container. The chamber can be coated with a friction
reducing material, anti-clotting material or the like normally used in
the analysis of blood.
The sealing plug of the present invention suspends the blood
in a fluid medium as it is collected, thus reducing the probability of
damaging the blood elements during the collection process.
In another embodiment, the sealing plug comprises a
plurality of sections which create a specimen flow diverting or
regulating means. The plurality of sections can be coated with a
friction reducing material, anti-clotting material or the like used in
the analysis of blood.
In still another embodiment, the sealing plug comprises a
plurality of sections which create a specimen flow diverting or
regulating means whereby an intermediate chamber is created by
joining the sealing plug sections together. The plurality of sections
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can also be coated with a friction reducing material, anti-clotting
material or the like normally used in the analysis of blood.
In another embodiment, the sealing plug comprises a
plurality of components which create a specimen flow diverting or
regulating means whereby an intermediate chamber is created by
joining the sealing plug and a separate component together. The
plurality of sections can also be coated with a friction reducing
material, anti-clotting material or the like used in the analysis of
blood.
In yet another embodiment, the vacuum tube sealing/plug is
provided having an adjustable flow diverting or regulating means
that diverts or regulates the flow into and/or within a collection
container. The flow diverting or regulating section sealing plug is
contained within the container opening.
In still yet another embodiment, the vacuum tube sealing
plug is provided having an adjustable flow diverting or regulating
means that diverts or regulates the flow into and/or within the
sealing plug. The sealing plug contains a secondary plug or section
which is denser than the sealing plug and is engaged by the needle
during the blood drawing procedure. The advancing needle moves
the secondary plug or section allowing a port on the sealing plug to
open and the specimen to enter the collection container at a
controlled rate. The secondary plug or section can be coated with a
friction reducing material, anti-clotting material or the like used in
the analysis of blood.
In another embodiment, a vacuum tube sealing plug, or
sealing closure is provided having an adjustable flow diverting or
regulating means that frictionally or threadedly engages the inner
section of the collection needle holder allowing the healthcare
worker to adjust the specimen flow into and/or within the
collection container. The engaging components may also be coated
with a friction reducing material.
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In one embodiment, the sealing plug includes a flow
diverting or regulating means to limit the specimen flow from the
chamber of the sealing plug into the inner cavity of the collection
container.
In another embodiment, the sealing plug includes a connected
flow diverting or regulating means to limit the specimen flow from
the sealing plug into the collection container.
In one embodiment, a specimen collection apparatus is
provided having a flow diverting or regulating means that diverts
or regulates the flow rate of a specimen into or within a specimen
collection container.
In one embodiment, a specimen collection apparatus is
provided with a removable shield over the sealing plug, which
protects the healthcare worker from being exposed to the patient's
blood during the collection and testing procedure and also allows
easy removal of the sealing plug from the collection container.
In another embodiment, the vacuum tube sealing plug is
provided having a flow diverting or regulating means that diverts
or regulates the flow into and/or within a collection container. The
sealing cap contains a least one opening, channel, cavity or area
which regulates the specimen flow through the sealing plug from a
hollow bore needle into the collection container. The flow
regulating opening, channel, cavity, area or passageway can also be
coated with a friction reducing material, anti-clotting material or the
like used in the analysis of blood.
In yet another embodiment, the vacuum tube sealing plug is
provided having a two piece flow regulating means that regulates
the flow into and/or within a collection container. The flow
regulating section is simply pushed into the sealing plug prior to
insertion into the opening of the container.
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In still yet another embodiment, the vacuum tube sealing
plug is provided having an filtering means that filters the specimen
as it flows into and/or within the sealing plug.
In another embodiment, a vacuum tube, sealing plug, or
sealing closure is provided having an adjustable flow diverting or
regulating means that frictionally or threadedly engages the inner
section of the collection needle holder allowing the healthcare
worker to adjust the specimen flow into and/or within the
collection container. The engaging components can be coated with a
friction reducing material, anti-clotting material or the like used in
the analysis of blood.
In one embodiment, the sealing plug includes a flow
diverting or regulating means to limit the specimen flow from the
chamber of the sealing plug into the inner cavity of the collection
container by means of a filter or reduced passageway.
In another embodiment, the sealing plug includes a connected
flow diverting or regulating means to limit the specimen flow from
the sealing plug into the collection container.
In another embodiment, the position of the needle tip in the
piercable sealing plug is provided so as to limit the longitudinal
movement of the needle tip only within the sealing plug chamber,
and not into the internal chamber of the collection container.
In yet another embodiment, a collection container is provided
having an enveloping coating or film to increase shatter resistance
of the collection container.
In one embodiment, a collection container is provided having
a breakable polymeric, elastomeric or the like coating or film applied
to the interface of the container and sealing plug to reduce the
probability of vacuum leakage from within the evacuated container.
This embodiment also serves as a vacuum leak or tampering
indicator. Breakage of this seal or coating will alert the healthcare
worker of a possible vacuum leak or tampering.
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In another embodiment, a collection container is provided
having a sealing plug with a sensor which is accessible from the
. outside of the collection container whereby the specimen can be
analyzed without removal of the sealing plug.
In another embodiment, a collection container is provided
having an automatically shielding sealing plug when a sealing plug
is removed from a collection container. Sliding shield covers the
inner surface of a sealing plug which has been in contact with a
collected specimen. The sliding shield closes sealing plug chamber
and traps any remaining specimen contained within chamber from
coming in contact with healthcare personnel.
In another embodiment, a collection container is provided
having a flow indicating or viewing area to observe specimen flow
during the collection process.
In still another embodiment, a collection container is
provided having either end being semi-circular for inserting either
end container into a centrifuge.
In another embodiment, a coupler or extension is disclosed
allowing a larger diameter collection container to be used with a
smaller diameter needle holder whereby a shallower angle is
available for accessing a insertion site.
In yet embodiment, a flow regulating coupler or extension is
disclosed allowing a larger diameter collection container to be used
with a smaller diameter needle holder whereby a shallower angle is
available for accessing a insertion site.
In one embodiment, a single collection container can be used
with needle holders having different diameters.
In another embodiment, a sealing plug with venting means is
provided to equalize the internal pressure within the collection
container with the ambient atmospheric pressure prior to full
removal of the sealing plug from the collection container.
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In one embodiment, a specimen is deposited in a chamber of a
sealing plug having external access, allowing a specimen to be placed
on a slide without using a needle to access the specimen.
In another embodiment, a needle with a sharp tip is used to
gain access to a filled collection container, with the other exposed
needle end having a blunted tip to reduce needle stick probability
and allow a specimen to be safely placed on a slide.
In another embodiment, a container with an improved
sealing plug/container surface interface is used to increase the shelf
life of the evacuated container.
In yet another embodiment, a sealing plug includes a porous
material to diffuse or filter a liquid being drawn into a container.
In still another embodiment, a sealing plug with a liquid
activated section allows a specimen to be collected, and prevents any
specimen remaining within a sealing plug to remain there during
the centrifuge process.
In another embodiment, a diverting component with at least
one aperture is inserted in the hollow end of a prior art sealing plug,
allowing existing sealing plug tooling and existing containers to be
utilized. This embodiment reduces the overall cost of
implementing the flow diverting or regulating invention. The size
of the aperture can be made smaller than the inner diameter area of
the needle used to puncture the sealing plug, reducing the specimen
flow and the probability of vein collapse. A procedure incorporating
a reduced aperture size in the diverter will take longer to complete
since the flow is reduced or restricted.
The aperture size can also be equal to or greater than the inner
diameter area of the needle used to puncture the sealing plug,
allowing full flow through the needle during the collection process.
A procedure incorporating an equal or increased aperture size in the
diverter will take the same amount of time as a standard blood draw.
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In one embodiment, a sealing plug with a pressure sensitive
valve is activated when a pressure difference exists on either side of
the valve.
In another embodiment, a sealing plug is shown with a
diverter having an aperture and an adjacent channel.
In another embodiment a blood collection needle with a
needle guard is shown where the needle guard can be selectively
activated by the user.
OBJECTS OF THE INVENTION
Wherefore, it is an object of the invention to provide a
hypodermic blood collecting apparatus and method which allows a
diverted, regulated, controlled, diffused, or variable specimen flow
into a collection container.
It is another object of the invention to provide a hypodermic
blood collecting apparatus and method which allows a regulated,
controlled, governed, gated, diverted, diffused or variable specimen
flow into through, or within a diaphragm or plug and into a
collection container.
It is also an object of the invention to provide a hypodermic
blood collecting apparatus and method which allows a regulated,
controlled, governed, gated, diverted, diffused or variable specimen
flow into a collection container without adding any additional parts
to the apparatus.
It is another object of the invention to provide a hypodermic
specimen collecting apparatus and method which allows a regulated,
controlled, governed, gated, diverted, diffused or variable specimen
flow into a collection container and looks and functions in a similar
manner to a standard, blood collecting hypodermic needle system.
It is yet another object of the invention to provide a
hypodermic blood collecting apparatus and method which allows a
regulated, controlled, governed, gated, diverted, diffused or variable
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specimen flow into a collection container which lends itself to
automated manufacturing.
It is a further object of the invention to provide a hypodermic
specimen collecting apparatus and method which allows a regulated,
controlled, governed, gated, diverted, diffused or variable specimen
flow into a collection container where the hypodermic specimen
collecting apparatus can be positioned away from the vascular access
site by means of a tube or the like.
It is still another object of the invention to provide a
hypodermic specimen collecting apparatus and method which
allows a regulated, controlled, governed, gated, diverted, diffused or
variable specimen flow into a collection container where the sealing
cap of the collection container comprises a flow regulating means.
It is an additional object of this invention to provide a
hypodermic specimen collecting apparatus and method which
allows a regulated, controlled, governed, gated, diverted, diffused or
variable specimen flow into a collection container where a variable
compressive or circumferential force is used to limit or regulate the
interaction between the sealing plug and the openable port of the
sealing plug.
It is another object of the invention to provide a hypodermic
specimen collecting apparatus and method which allows a regulated,
controlled, governed, gated, diverted, diffused or variable specimen
flow into a collection container where a variable compressive force
is used to limit or regulate the interaction between the needle holder
and the collection container.
It is also an object of the invention to provide a low-cost
hypodermic specimen collecting apparatus and method which
allows the specimen to primarily remain in a fluid medium,
cushioning its flow into and within a collection container.
It is another object of the invention to provide a hypodermic
specimen collecting apparatus and method which allows a specimen
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flow into a collection container where at least one diaphragm or
barrier regulates, restricts, diverts or controls the specimen flow
within a collection container.
It is a yet an additional object of the invention to utilize the
flow regulation means to other collection or transferring procedures,
such as transferring blood from a syringe to a collection container.
It is still another object of this invention to provide a
specimen collecting apparatus that reduces the probability of
collapsing a blood, or other bodily, vessel of a patient during a
specimen drawing procedure.
It is a further object of the invention to reduce specimen
trauma during the specimen collection procedure.
It is another object of the invention to provide a specimen
collecting apparatus and method which minimizes the hemolysis of
a specimen collected during a blood collection procedure.
It is still another object of the invention to provide a flow
reducing, then increasing means on a sealing plug which regulates
the specimen flow into a collection container.
It is a still further object of the invention to provide a filtering
means within, in, or adjacent to, a sealing plug which regulates,
controls, governs, gates, diverts or adjusts the specimen flow into a
collection container.
It is another object of the invention to provide a sensing
means within a sealing plug or container which determines the
status of the blood, blood elements, or blood gasses while the blood is
contained within the collection container, sealing plug chamber or
passageway.
It is yet another object of the invention to provide a protective
coating or film on a collection container to reduce breakage and leak
probability during manufacturing, storage and use.
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It is still another object of the invention to provide a coating
or film on a collection container seal to prevent vacuum leakage of
the collection container prior to use.
It is another object of the invention to preserve the shelf life
of the collected specimen in the best possible condition for as long as
possible.
It is another object of the invention to keep the collected
specimen cells alive and living until they are analyzed.
It is an object of the invention to provide a collection
container which has a sealing plug, which when removed,
automatically shields the surfaces of a sealing plug which have been
in contact with a specimen in a collection container.
It is another object of the invention to provide a collection
container which has a flow indicating means viewable by the user.
It is another object of the invention to provide a coupler
which allows a large diameter collection container to be used with a
smaller diameter needle holder.
It is yet another object of the invention to provide a flow
regulating coupler which allows a large,diameter collection
container to be used with a smaller diameter needle holder.
It is still another object of the invention to provide a single
collection container which can be used with needle holders having
different diameters.
It is another object of the invention to provide a needle access
angle which is as close as possible to being parallel with the plane of
the insertion site.
It is a further object of the invention to provide a venting
means to equalize the internal pressure within a collection container
with the ambient atmospheric pressure prior to full removal of a
sealing plug from a collection container.
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It is another object of the invention to provide access to a
small amount of specimen from a collection container without
using a needle to obtain the specimen.
It is still another object of the invention to provide a hollow
bore needle with one sharp tip to gain access to a filled container,
with the other exposed needle end having a blunted tip to reduce
needle stick probability and allow a specimen to be safely placed on a
slide.
It is another object of the invention to provide a means to
diffuse the liquid entering a container.
It is still a further object of the invention to provide an
improved sealing means at the sealing plug/container surface
interface.
It is still another object of the invention to provide an
improved sealing means at the sealing plug/container surface
interface which may include a specimen diverting, diffusing or
regulating means.
It is another object of the invention to provide a sealing plug
with a pressure sensitive valve means which is activated when a
pressure difference exists on either side of the valve.
It is another object of the invention to provide a sealing plug
with a diverting means and an adjacent channel which allows a
specimen to be collected in a normal manner where the blood
collection needle punctures a sealing plug in a normal concentric
manner, and a longer needle for obtaining the collected specimen for
analysis punctures the sealing plug in an eccentric manner without
contacting any specimen residing in the chamber created by the
sealing plug and diverter.
It is a further object of the invention to provide a blood
collection needle where a needle guard can be selectively activated
only by a manual releasing means.
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For simplicity sake, the numbered components shown herein
could be interchanged throughout the drawings, providing a variety
of combinations of the described invention.
Other objects and benefits of this invention will become
apparent from the description which follows hereinafter when read
in conjunction with the drawing figures which accompany it.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention is illustrated by way of example and is
not limited by the figures of the accompanying drawings, in which
like references indicate similar elements and in which:
Figure 1 illustrates a prior art blood collection apparatus.
Figure 2 shows a blood specimen being introduced into the
prior art blood collection apparatus of Figure 1.
Figure 3 illustrates a full view of a sealing plug for a blood
collection container having a chamber open to the side of the sealing
plug.
Figure 4 illustrates a side view of a specimen collection needle
and a cross sectional view of a needle holder and collection tube
with a full view of a sealing plug of the present invention having a
sealing plug with an intermediate chamber.
Figure 5 illustrates the blood collection apparatus of Figure 4
with a cross sectional side view of a sealing plug.
Figure 6 shows the apparatus of Figure 5 with a specimen
being introduced into the collection tube.
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Figure 7 illustrates a cross sectional side view of a sealing plug
with one chamber.
Figure 8 illustrates a cross sectional view of the sealing plug of
Figure 7 inserted in the open end of a container wherein the
chamber has at least one aperture or port.
Figure 9 illustrates a full bottom view of the sealing plug of
Figure 7.
Figure 10 shows a full bottom view of one embodiment of the
present invention comprising a plurality of channels.
Figure 11 illustrates another embodiment of the present
invention whereby the sealing plug regulates the specimen flow by
partially impeding or blocking the specimen exiting the hollow bore
of the needle lumen.
Figure 12 shows a full bottom view of the sealing plug of
Figure 11.
Figure 13 illustrates a cut away view of a sealing plug in
another embodiment of the invention.
Figure 14 illustrates a cut away view of the sealing plug of the
present invention having a plurality of reducing channels or
apertures.
Figure 15 illustrates a cut away view of the present invention
wherein the sealing plug of the specimen collection container
comprises a plurality of increasing or expanding channels.
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Figure 16 illustrates one embodiment of the present
invention wherein the sealing plug of the specimen collection
container comprises two components.
Figure 17 is a cross sectional view of the sealing plug shown in
Figure 16.
Figure 18 is a cross sectional view of one embodiment of the
present invention shown as molded.
Figure 19 shows a sealing plug with a hinge ready to be
inserted into the open end of a collection container.
Figure 20 illustrates a sealing plug of the present invention
having a reed valve.
Figure 21 illustrates a sealing plug of the present invention
having a recessed reed valve.
Figure 22 illustrates the sealing plug shown in Figure 20.
Figure 23 illustrates the sealing plug shown in Figure 21.
Figure 24 illustrates another embodiment of the present
invention whereby the sealing plug comprises a movable
component with a closed port or aperture, and the needle holder
comprises a compressive longitudinal resisting member.
Figure 25 shows the sharpened tip of the needle engaging a
movable component of the sealing plug and opening the aperture.
The vacuum tube closure and needle holder provide a threaded or
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frictional means to adjust the specimen flow into the collection
container.
Figure 26 shows a cross sectional view of the sealing plug of
the present invention with a movable component and closed
aperture.
Figure 27 shows a cross sectional view of the sealing plug of
the present invention with an integrally molded movable
component and closed aperture.
Figure 28 illustrates a cross sectional view of a prior art
hypodermic needle wall.
Figure 29 illustrates a cross sectional view of a hypodermic
needle wall wherein the inner wall is coated with a friction reducing
material, filler or anti-clotting material.
Figure 30 shows a vacuum tube and needle holder provided
with a threaded or frictional means to adjust the specimen flow into
a collection container.
Figure 31 illustrates a cross sectional view of a needle with an
expanded needle bore.
Figure 32 illustrates a cross sectional view of a collection
container with sealing plug and an adjacent chamber.
Figure 33 shows a cross sectional view of a collection tube
with a multi-chamber sealing plug.
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Figure 34 illustrates a specimen collection needle and needle
holder with a specimen collection tube of the present invention
having a sealing plug with an intermediate chamber, passageway
and a shield engaging the sealing plug.
Figure 35 illustrates a cross sectional side view of the assembly
of Figure 34 with the needle tip residing within the intermediate
chamber.
Figure 36 shows the apparatus of Figure 35 with an outer
sealing means and a reducing internal chamber.
Figure 37 illustrates a partial cut away side view of a collection
container having a sealing plug with one intermediate chamber and
a filter means.
Figure 38 illustrates a two piece sealing plug of the present
invention wherein the intermediate chamber is created by adjoining
two components together.
Figure 39 illustrates a full bottom view of the sealing plug of
Figure 38:
Figure 40 shows a partial cross sectional view of one
embodiment of the present invention comprising an adjustable flow
regulation means.
Figure 4I illustrates an alternative side view of the apparatus
shown in Figure 40.
Figure 42 shows a partial cut away side view of a prior art
collection container.
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Figure 43 illustrates a cross sectional view of one embodiment
of the present invention of a collection container with a protective
coating or film on the outer surface of the container.
Figure 44 illustrates a cross sectional view of one embodiment
of the present invention of a collection container with a coating or
film on the outer surface of the collection container extending over
the outer surface of the interface of the sealing plug and container.
Figure 45 illustrates a cross sectional view of one embodiment
of the present invention of a collection container with a coating,
film or label on the outer surface of the interface of the sealing plug
and container.
Figure 46 illustrates a partial cut away view of the present
invention wherein the sealing plug of a collection container
includes a sensor which is accessible to both the inside and the
outside of the container.
Figure 47 illustrates another embodiment of the present
invention with a sealing plug and a diverting component.
Figure 48 illustrates another embodiment of the present
invention with a sealing plug and a diverting component with an
internal well.
Figure 49 illustrates a side view of a diverting component that
may be joined to a sealing plug of the present invention.
Figure 50 illustrates a bottom view of a diverting component
which shown in Figure 49.
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Figure 51 illustrates a cross sectional side view of a sealing
plug in one embodiment of the present invention.
Figure 52 illustrates a full bottom view of the sealing plug
shown in Figure 51.
Figure 53 illustrates another embodiment of the present
invention of a self-shielding sealing plug residing in an openable
end of a container.
Figure 54 illustrates a cross sectional view of the sealing plug
of Figure 53 with a self-shielding sealing plug removed from an
openable end of a container with a slidable shield activated on a
sealing plug.
Figure 55 illustrates another embodiment of a sealing plug
and shield with a flow indicating or viewing section.
Figure 56 illustrates a cross sectional view of a collection
container of the present invention with rounded ends.
Figure 57 illustrates a cross sectional view of the present
invention wherein a coupler or extension allows a large diameter
collection container to be used with a needle holder having a
diameter smaller than the larger diameter container.
Figure 58 illustrates a cross sectional view of the present
invention wherein a flow regulating coupler or extension allows a
large diameter container to be used with a needle holder having a
diameter smaller than the larger diameter container.
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Figure 59 illustrates cross sectional view of the present
invention wherein a single collection container can be used with
needle holders having different size diameters.
Figure 60 illustrates a side view of a sealing plug of the present
invention with a venting means.
Figure 61 illustrates a full bottom view of the sealing plug of
Figure 60.
Figure 62 illustrates a cross sectional view of a sealing plug
shown in Figure 60 closing a open end of a collection container.
Figure 63 illustrates a cross sectional view of a sealing plug
shown in Figure 62 exposing the internal chamber of a collection
container to the outside of a container prior to full removal of a
sealing plug from a collection container.
Figure 64 illustrates a cross sectional view of a sealing plug of
the present invention with a sealed chamber having external access.
Figure 65 illustrates a cross sectional view of the sealing plug
of Figure 64 with a chamber being open.
Figure 66 illustrates a full side view a sealing plug of the
present invention with a movable shield having an aperture.
Figure 67 illustrates a full side view of the sealing plug of
Figure 66 with the aperture of a movable shield positioned adjacent
to a chamber of the sealing plug.
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Figure 68 illustrates a cross sectional view of a sealing plug
and a movable shield shown in Figure 66.
Figure 69 illustrates a cross sectional view of a sealing plug
and movable shield of Figure 67 with the aperture of a movable
shield positioned adjacent to a chamber of a sealing plug.
Figure 70 illustrates a cross sectional side view of a container
with a sealing plug including a means to diffuse fluid entering the
container.
Figure 71 illustrates the blood collection apparatus of Figure 70
with a specimen being diffused as it is introduced into the container.
Figure 72 illustrates a partial, cross sectional side view of a
container with a sealing plug including an aperture with a liquid
activated section.
Figure 73 illustrates a cross sectional side view of the
container of Figure 72 containing a liquid with the aperture closed at
the liquid activated section.
Figure 74 illustrates a cross sectional view of the present
invention with a diverting means combined with a prior art sealing
plug. The diverting component may also include a means to
improve the seal at the sealing plug/container surface interface.
Figure 75 illustrates a cross sectional view of the present
invention with a means to improve the seal at the sealing
plug/container surface interface.
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Figure 76 illustrates a cross sectional view of the present
invention having a sealing plug with a pressure sensitive valve
. which is activated when a pressure difference exists on either side of
the valve.
Figure 77 is a full side view of the valve component of Figure
76.
Figure 78 illustrates a cross sectional side view of a sealing
plug with a diverter having an open channel or slot for accessing the
specimen in a container with a long needle without having to
remove the sealing plug.
Figure 79 illustrates a cross sectional top view of the diverter
of Figure 78 having an open channel or slot and a diverter chamber
separated by a wall section.
Figure 80 illustrates a blood collection needle with a needle
guard which can only be activated manually.
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DETAILED DESCRIPTION
An apparatus and method for collecting a blood specimen or
other bodily fluid or gaseous substance is described. In the following
description, numerous specific details are set forth, such as material
types, dimensions, processes, etc., in order to provide a through
understanding of the present invention. However, it will be
obvious to one of ordinary skill in the art that the invention may be
practiced without these specific details. In other instances, well-
known structures and processing steps have not been shown in
particular detail in order to avoid unnecessarily obscuring the
present invention. Additionally, it should be noted that this
discussion will focus primarily on the collection of blood from a
human patient. It should be understood, however, that such focus is
for illustrative purposes only. The present invention is not limited
to blood collection nor is it limited to the collection of a specimen
sample from a human patient.
The container used to collect a specimen, referred to as 40
throughout this application, is made of glass, plastic resin, or a
composite material and is normally evacuated and closed by a
puncturable sealing plug. The internal cavity, referred to as 43
throughout this application, is the void or chamber within the
container 40.
Referring to Figure 3, a full side view of a sealing plug 41
having a chamber 61 openly connected to the side of the sealing
plug. Sealing plug 41 is insertable into the open end of a container.
Figure 4 is a full view of a blood collection needle 21 and
sealing plug 41 are shown, and a cross sectional view of a needle
holder 30, proximal needle cover 25 and container 40 are shown.
Collection tube 40 has an open end and closed end, with inner cavity
43 created by placing sealing plug 41 in the open end for maintaining
a sub-atmospheric pressure within the tube.
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Piercable sealing plug 41 comprises a diverting means 73 and
at least one chamber 61 for diverting a specimen flow as it enters the
. sealing plug. Chamber 61 is connected to internal chamber 43 of
container 40 by at least one passageway 60. Container 40 is
positioned in a cavity 35 of needle holder 30. Needle 21 has a
sharpened, distal end 20 and proximal end 23. Distal end 20 is
insertable into a blood vessel to obtain a specimen sample of blood
for examination. Proximal end 23 resides within needle holder 30
and pierces sealing plug 41 during the collection procedure allowing
specimen to flow from a blood vessel and into container 40. Needle
21 includes a lumen 24 communicating openly with each end
creating a passageway from proximal end 23 to distal end 20. A
needle cover 25 is typically provided to seal the proximal end of the
needle 21.
Sealing plug 41 automatically diverts the specimen from its
original fluid path when the sealing plug 41 is initially punctured by
the needle 21, eliminating the probability of the specimen gaining
momentum as it enters container 40. The size of passageway 60 may
be lesser, equal to, or greater than the area of the needle lumen. A
passageway 60 equal to or greater than the area of the needle lumen
allows the specimen to flow freely. A passageway 60 smaller than
the area of the needle lumen reduces and regulates the specimen
with no change in the collection process.
Figure 5 shows a cross sectional view of container 40, sealing
plug 41 and needle holder 30 of Figure 4 with container 40
positioned within cavity 35 of needle holder 30. Sealing plug 41
includes at least one chamber 61 for diverting a specimen flow. In
one embodiment, chamber 61 includes a diverting means 73 in the
front of a convex wall section which regulates specimen flow from a
patient to a collection container 40. Convex wall section allows any
specimen remaining in chamber 61 to flow into container 40 prior
to, or during the centrifuge process.
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At least one passageway or aperture 60 is provided between
chamber 61 to provide fluid communication between chamber 61
and tube cavity 43. Diverter 73 can include a dissolvable material,
which diverts the specimen during the collection process and
dissolves after the specimen is collected. A dissolvable material may
also be used which facilitates analysis of the collected specimen.
A smaller or reduced passageway 60 is capable of regulating
the volume of specimen being collected to prevent vein collapse
associated with standard blood collection procedures. Different
passageway 60 sizes would allow a variety of flow collection rates to
be achieved without changing any currently used techniques.
Figure 6 is a cross sectional view of Figures 4 and 5 showing a
specimen being introduced first into chamber 61 of sealing plug 41
and then into container 40. Specimen flow is diverted from needle
21 prior to entering internal cavity 43 of collection container 40 by
diverter 73, chamber 61 and passageway 60. Sealing plug 41
maintains specimen within container 41 after collection, keeping the
specimen free of contamination.
Figure 7 is a cross sectional view of a sealing plug shown in
axis 7-7 in Figure 9 used to close a collection container, comprising
chamber 261 and diverter 273 for regulating, governing, diverting,
reducing, increasing, re-directing or interrupting the specimen flow
through, into or within sealing plug 241 during blood collection
procedures, chamber 261 is positioned adjacent to recess 260.
Figure 8 is a cross sectional view of a container 40 of the
present invention having one open end, a closed end and an
internal chamber 43. The open end being sealingly closed by
removable sealing plug 241 with a diverter 273, at least one chamber
261 and at least one recess or void 260 creating an inner channel, port
or passageway when sealing plug 241 is positioned within open end
of container or evacuated tube 40. The sealing plug 241 and chamber
261 could also have a smaller cross sectional thickness to reduce the
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overall mass of the plug. By reducing the size and mass of the
sealing plug, manufacturing costs are lowered.
The inner wall of container or collection tube 40 or chamber
261 may also include a coating, additive, gel, inert polymer, or other
substances which are used in the normal course of collecting and
analyzing blood and blood products.
Figure 9 is a full bottom view of the sealing plug of Figure 7
comprising a sealing plug 241, used to close a container, having a
diverter 273 for regulating, governing, diverting, reducing,
increasing, re-directing or interrupting specimen flow through, into
or within sealing plug 241 and through at least one recess 260 during
blood collection procedures, recess 260 creates an inner channel or
passageway when sealing plug 241 is positioned in or within the
open end of container or evacuated tube 40. Sealing plug 241 may
include a passageway from the intermediate chamber directly
through the bottom of diverter 273, eliminating the need to be
positioned in or within the open end of container or evacuated tube
to create a passageway.
Figure 10 is a full bottom view of another embodiment of a
sealing plug 241, used to close a container, having a diverter 273, and
a plurality of recesses, ports or channels 360 for regulating, diverting,
re-directing, reducing, increasing or interrupting the specimen flow
through, into or within sealing plug 241 during blood collection
procedures. Recess 360 creates an inner channel or passageway when
sealing plug 241 is inserted in or within the open end of container or
evacuated tube.
Figure 11 is a cross sectional side view of a collection container
40 with an internal chamber 43, with a cut away view of a sealing
plug 441, used to close container 40, having a plurality of uniformly
sized distal apertures or channels 467 for regulating, controlling or
slowing the specimen flow through, into or within sealing plug 441
before the specimen enters container 40. Although apertures 467 are
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shown having a uniform shape here, they may be tapered, irregular,
contoured or the like.
Figure 12 is a full bottom view of the sealing plug of Figure 11
comprising sealing plug 441, which may include an elastomeric
material sufficient to frictionally engage and seal an internal
chamber of a container, and at least one section 467 to regulate,
control or slow specimen flow through, into or within sealing plug
441. Regulating means 467 may comprise a honeycombed, specific or
random pattern.
Figure 13 is a partial cut away side view of a sealing plug of the
present invention showing a flow regulating means comprising
sealing plug 114, having a plurality of internal chambers 166 for
accepting the end of a tube or needle which pierces sealing plug 114
and enters chambers 166, a reduced distal aperture 167 for regulating
or slowing the specimen flow through, into or within sealing plug
114 before the specimen enters a connected collection container.
Although internal chambers 166 are shown at one depth here, they
may be positioned or staggered at different levels or depths to
facilitate core extraction during manufacturing.
Figure 14 is a partial cut away side view of a sealing plug of the
present invention used to close a collection container, showing a
flow controlling means comprising sealing plug 214, having a
plurality of chambers 266 for accepting the end of a tube or needle
which pierces sealing plug 214 and enters chambers 266. Reduced
distal apertures 267 for regulating or slowing the specimen flow
through, into or within sealing plug 214 before the specimen enters a
connected collection container. Although internal chambers 266 are
shown at one depth here, they may be positioned or staggered at
different levels or depths to facilitate core extraction during
manufacturing.
Figure 15 is a partial cut away view of sealing plug of the
present invention used to close a container showing a flow
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regulating means comprising a sealing plug 314, having a plurality
of chambers 366 for accepting the end of a tube or needle which
pierces sealing plug 314 and enters chambers 366, increasing or
expanding distal apertures 367 for regulating, slowing or increasing
specimen flow through, into or within sealing plug 314 before the
specimen enters a collection container. Although internal chambers
366 are shown at one depth here, they may be positioned or staggered
at different levels or depths to facilitate core extraction during
manufacturing. The specimen flow increases as the needle is
advanced further into or through increasing chambers 366.
Figure 16 is a full side view of a two-piece sealing plug of the
present invention used to close a container having a piercable
section 32 and a flow regulating or diverting section 42. Flow
diverting section 42 having at least one aperture 767 for regulating,
diverting or slowing the specimen flow through, into or within
sealing plug 32 as specimen exits needle. Section 42 being slightly
smaller in diameter or size than section 32 for easy removal of both
sections 32 and 42 from a collection container. Section 42 may also
be the same size diameter as section 32.
Figure 17 is a cross sectional side view of the two-piece sealing
plug shown in Figure 16 having a piercable section 32 and a flow
regulating section 42. Flow regulating section 42 having a plurality
of chambers 66 for accepting the end of a tube or needle which
pierces sealing plug 32 and enters chambers 66. Chambers 66 are
connected to a plurality of distal apertures 767 for regulating or
controlling specimen flow through, into or within sealing plug 42
Although internal chambers 66 are shown at one depth here, they
may be positioned or staggered at different levels or depths to
facilitate core extraction during manufacturing.
Figure 18 is a cross sectional side view of a two section sealing
plug of the present invention having a joinable sealing plug 532
used to close a container. Sealing plug 532 is shown in an open faced
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configuration having two connected sections with piercable section
532, connected to a flow regulating section 542 having a recess 68 for
creating an internal chamber when sealing plug sections 532 and 542 .
are joined together, and connecting means 70. Flow controlling
section 542 having at least one recessed chamber 68 for accepting the
end of a tube or needle which pierces sealing plug 532 and enters the
chamber 68. Chamber 68 is connected to a plurality of distal
apertures 567 for regulating or diverting the specimen flow through,
into or within sealing plug 542 as specimen exits needle.
Although internal chamber 68 is shown at one depth here, it
may be manufactured having different levels or depths. This open
faced. embodiment of the flow controlling sealing plug 542 allows a
wide variety of flow controlling features to be easily incorporated
into the invention during manufacture, including, but not limited
to, reducing, increasing, tapered or contoured shapes of distal
aperture 567.
Figure 19 is a cross sectional side view of a two part sealing
plug 632 shown in Figure 18, now shown in a joined configuration
having two connected sections 632 and 642, with one piercable
section 632 having recess 668 for creating a chamber when sealing
plug sections 632 and 642 are joined together, a connected piercable,
flow controlling section 642, and connecting means 670. Piercable
sealing plug 632 having at least one internal recessed chamber 668
for accepting the end of a tube or needle which pierces sealing plug
632 and enters chamber 668. Flow controlling section 642 having a
plurality of distal apertures 667 for controlling or diverting the
specimen flow through, into or within sealing plug 642 as specimen
exits needle.
Although internal recessed chamber 668 is shown at one
depth here, it may be manufactured having different levels or
depths. Sealing plug sections 632 and 642 join together, shown here
having a male pin or post 79 into a female aperture or section.
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Joining section may also comprise an undercut, or other means for
fixedly attaching or joining sealing plug sections 632 and 642
together.
' Figure 20 is a partial cut away view of a sealing plug of the
present invention comprising one-piece, puncturable sealing plug 37
used to close a collection container showing a flow controlling
means with intermediate chamber 168 and flow controlling reed
valve 76.
Figure 21 is a partial cut away view of a sealing plug of the
present invention comprising a one-piece, puncturable sealing plug
137 used to close a container showing a recessed flow controlling
means including a chamber 268, piercable wall section 77 and flow
controlling reed valve 176. As the needle is advanced into chamber
268, reed valve 176 allows the specimen to flow into a container.
The needle can be advanced further to pierce wall section 77,
allowing a direct specimen flow into a container during the
collection procedure.
Figure 22 is a full bottom view of the sealing plug shown in
Figure 20 comprising sealing cap 37 with a reed valve 76.
. Figure 23 is a full bottom view of the sealing plug shown in
Figure 21 comprising sealing cap 137 with a recessed chamber wall 77
and reed valve 176.
Figure 24 is a cross sectional view of a blood collecting
apparatus of the present invention prior to insertion showing a full
view of needle 21, a cross sectional view of needle holder 230 and
container 40 having an internal cavity 43 with an adjustable flow,
puncturable sealing plug 83, internal chamber 368, openable valve or
port 75 and movable, substantially impenetrable secondary plug or
diverter 80. Port 75 is shown here closed and adjacent to port or
passageway 160. Needle holder 230 having a plurality of projections
34 for compressively resisting axial movement of container 40. A
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compressive force must be placed on container 40 in holder 230 to
collect specimen.
Figure 25 is a cross sectional view of the blood collecting
apparatus of the present invention during the collection process
comprising needle 21, needle holder 330 and container 40 having an
internal cavity 43 with an adjustable flow, puncturable sealing plug
183, internal chamber 468, openable valve or port 175 and movable,
substantially impenetrable secondary plug 80. As needle 21 enters
chamber 468, needle tip 23 engages diverter 80 which opens port 175
allowing specimen to flow into inner cavity 43 of collection tube 40.
Port 175 opening can be reduced by partially disengaging needle tip
23 from movable plug 80. Port 175 opening can be closed completely
by fully disengaging needle tip 23 from secondary plug 80.
Penetration-related adjustable flow is rotationally controlled
by frictional or threaded means 84 of sealing plug 183 and frictional
or threaded means 82 of needle holder 330.
Figure 26 is a cross sectional side view of an adjustable flow
sealing plug of the present invention used to close a container, used
in the same manner as the sealing plugs shown in Figures 25 and 26,
comprising a puncturable sealing plug 283 having an intermediate
chamber 568, openable port 275, and movable plug 88 with a
uniformly consistent wall section.
Figure 27 is a cross sectional side view of an adjustable flow,
puncturable sealing plug of the present invention comprising a
sealing plug 85 having an intermediate chamber 668, openable port
675, and integrally molded, substantially impenetrable section or
stop 81, which is movable when a needle engages stop 81.
Figure 28 is a cross sectional front view of a prior art hollow
bore needle 121 having an outer smooth wall and rough inner wall
111.
Figure 29 is a cross sectional front view of hollow bore needle
of the present invention having an outer smooth wall, with an
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inner wall 211 being coated with friction reducing lubricant 212 to
reduce the rough surface of the inner wall 211. Inner wall 211 may
also be manufactured in a smooth fashion by mechanical or
chemical means. Lubricant or filler 212 is deposited into recesses of
inner wall 211, creating a smoother, inner wall surface. Inner wall
coating 212 can also comprise a material which inhibits blood
clotting.
Figure 30 is a cross sectional view of a blood collecting
apparatus of the present invention during the collection process
comprising a needle 21, needle holder 430 and container 240 having
an inner cavity 43 with an inserted sealing plug 441 having a
plurality of uniformly sized distal apertures 467 for controlling or
diverting the specimen flow through, into or within sealing plug 441
as the specimen exits the needle 21.
Penetration-related adjustable flow is controlled by rotational
movement of container 240 relative to needle holder 430 by
projection or thread 86 of container 240 and corresponding
projection or thread 182 of needle holder 430. Penetration-related
adjustable flow may also be controlled by frictional engagement of
container 240 and needle holder 430.
Figure 31 is a cross sectional view of a blood collecting
apparatus of the present invention prior to use comprising a needle
21 connected to enlarged bore needle 321, needle holder 30 and
collection container 140 having inner cavity 143 and sealing plug
141.
Figure 32 is a cross sectional view of a container of the present
invention showing a container 40 having inner cavity 43, a
puncturable sealing plug 55 with separate membrane 29 with at least
one aperture or port 867 whereby a membrane 29 creates
intermediate chamber 868 adjacent to sealing plug 55. Membrane 29
can be permeable, or impermeable with at least on pre-pierced
section 867.
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Figure 33 is a cross sectional view of a collection container of
the present invention showing container 40 having inner cavity 43,
with open end of container 40 being sealed by a multi-chambered
sealing plug 65 with inner chamber 968 and secondary chamber 69
created by diverter 973. Chamber 69 is connected to first chamber
968 by port, aperture or passageway 72. Specimen flows first into
chamber 968 then into chamber 69 through port or passageway 960 to
inner cavity 43. Secondary chamber 69 is originally a recess or
channel of sealing plug 65 and creates chamber 69 when sealing plug
65 is positioned in or within the open end of container or vacuum
tube 40.
Sealing plug 65 has an external configuration similar to a
standard syringe piston.
Figure 34 illustrates a blood collection apparatus of the present
invention prior to use with a full view needle 21 and sealing plug
51, with a cross sectional view of needle holder 30, tube 40 and a
partial cut away view of shield 50, comprising a puncturable sealing
plug 51 with inner chamber 361 and passageway 360 connected to
internal chamber 43 of container 40. Sealing plug 51 comprises at
least one intermediate chamber 361 for regulating or diverting
specimen flow from a needle 21 to a container 40. Shield 50 is
connected to sealing plug 51 at interface 46 for removal from
container 40, reducing exposure of blood and bodily fluids to
healthcare workers during collection and testing procedures. Shield
50 having a radially extending face covering top of shield 50 with
aperture or opening 44 for accessing sealing plug 51 with needle 21.
Sealing plug 51 is contained within shield 50 which extends
annularly around sealing plug 51.
Shield 50 facilitates easy removal of sealing plug 51 from
container 40. Container 40 is positioned in cavity 35 of needle holder
30. Distal end 20 of hollow bore needle 21 is insertable into a blood
vessel to obtain a specimen sample of blood for examination.
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Figure 35 shows a cross sectional side view of collection
container of Figure 34 during use with container 40 having sealing
plug 51 with at least one intermediate chamber 361 for diverting or
maintaining specimen flow in a fluid suspension as specimen is
collected from a patient to container 40. At least one port or aperture
360 provides a passageway between chamber 361 of sealing plug 51
and internal cavity 43 of container 40. Sealing plug 51 having a
shield 50 to facilitate easy removal of sealing plug 51 from container
40. Sealing plug 51 having at least one recess 46 which may be
annular or intermittent for fittingly engaging sealing plug 51 and
protrusion or lip 45. Shield 50 having a recess 55 for fittingly
engaging protrusion 45 of sealing plug 51. Shield 50 having at least
one projection 56 which may be annular or intermittent for
attaching sealing plug 51.
Chamber 361 is manufactured in a pre-determined position
whereby relationship of needle tip 23 penetrates only into chamber
361, and not directly into internal chamber 43 of container 40.
Needle tip 23 could also be manufactured longer to penetrate
intermediate chamber 361 first to allow specimen flow from needle
21, and with further axial advancement needle tip 23 could reside
within diverting means 373, stopping specimen flow during the
collection process, and finally needle tip 23 could also be
manufactured to penetrate intermediate chamber 361 first to allow
specimen flow from needle 21 and with further axial advancement
needle tip 23 could reside within diverting means 373, stopping
specimen flow during the collection process, and with even further
axial advancement, needle tip 23 could penetrate through diverting
means 373 and directly into internal chamber 43 of container 40,
totally bypassing intermediate chamber 361 and diverting means 373
and allowing direct specimen flow from needle 21 into container 40.
Figure 36 is a cross sectional side view of a collection container
of the present invention showing container 40 having sealing plug
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541, intermediate chamber 561 with reducing section 62 to control,
regulate or divert specimen flow into container 40 with passageway
560 connecting intermediate chamber 561 to internal chamber 43.
Sealing plug 541 having an extending outer section 22 for
maintaining a sub-atmospheric pressure within container 40.
Figure 37 is a partial cut away view of a collection container of
the present invention having one open end and an internal
chamber 43, with a sealing plug 641 used to close container 40.
Sealing plug 641 having chamber 661 for regulating, governing,
diverting, re-directing, reducing, increasing or interrupting the
specimen flow through, into or within sealing plug 641 during blood
collection procedures. Passageway 660 connects intermediate
chamber 661 to internal chamber 43. Chamber 661 having filtering
means 63 to filter or control specimen flow during blood collection
procedures. Filtering means 63 may also comprise a dissolvable
material. Sealing plug 641 having an extending outer section 22 for
maintaining a sub-atmospheric pressure within container 40.
Figure 38 is a cross sectional view of a collection container of
the present invention comprising a container 40, having one open
end and internal chamber 43, open end being sealingly closed by
removable, puncturable sealing plug 71 with at least one diverting
component 74 creating chamber 761 and at least one recess 760 for
creating an inner channel, port or passageway to internal chamber 43
when sealing plug 71 is positioned within open end of container or
evacuated tube 40. Diverter 74 having an angled lead-in section 86
for easy assembly of component 74 to sealing plug 71. Sealing plug
71 having a chamfered or tapering bottom perimeter 65 for easy
insertion into open end of container 40.
Internal cavity 43, inner wall of the tube 40 or diverter 74 may
also include a coating, additive, gel, inert polymer, or other
substances which are used in the normal course of analyzing blood
and blood products.
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Smaller sized sealing plug 71 requires less puncturable
material to close a collection container by adding another iow-cost,
. diverting component 74 to create chamber 761 and passageway 760.
Indicator 64 is shown on sealing plug 71 to determine the location of
passageway 760 leading from sealing plug 71 into internal chamber
43 of container 40. Indicator 64 is shown directly adjacent to
passageway 760 of sealing plug 71. Indicator 64 can also be placed at
any position, or directly opposite, or 180° away from, the location of
passageway 760.
Diverting component 74 may include a hinged section
whereby diverting section is maintained in a diverting position
during the normal collection procedure and is opened by the
centrifugal force generated during the centrifuge process. This
allows any specimen remaining within an intermediate chamber to
be combined with the specimen in the internal chamber 43 of
container 40.
Diverting component 74 may also re-direct specimen flow first
toward the sidewall of container 40 and then directly into internal
cavity 43; forming a "Z" like configuration.
Figure 39 is a full bottom view of the sealing plug shown in
Figure 38 comprising a sealing plug 71, with a chamfered section 65,
an indicator 64, and a separate diverter 74. Diverter 74 may include a
dissolvable material when activated by a wet solution like blood.
Figure 40 is a full, cross sectional and partial cut away view of
a blood collecting apparatus of the present invention showing
sealing plug 51 being partially pierced by needle 21. The blood
collection apparatus comprises a blood collection needle 21, a needle
holder 530, and a container 40 with a sealing plug 51 and shield 150.
Sealing plug 51 is used to close container 40, and has at least one
intermediate chamber 361 and diverter 373 for regulating, diverting,
re-directing, reducing, increasing or interrupting the specimen flow
through, into or within sealing plug 51 during blood collection
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procedures. Recess 360 creates an inner channel or passageway when
sealing plug 51 is positioned in or within the open end of container
40.
Shield 150 having an aperture 44 for unrestricted access of
needle 21 into sealing plug 51, and a projection 52 for frictionally or
rotationally engaging needle holder 530 and internal open-faced
projection 54. Projection 52 engages projection 54 during rotational
movement of container 40 towards needle 21, maintaining a
positive control during sealing plug 51 puncture by needle 21. Direct
axial removal of container 40 is unrestricted due to the open-faced
configuration of projection 54 of needle holder 530, allowing
container 40 to be removed by a straight pulling movement like a
standard collection container is now removed from a needle holder.
Penetration-related adjustable specimen flow is regulated by
frictional or threaded engagement of projection 52 of container 40 or
shield 150 and frictional or threaded engagement of projection 54 of
needle holder 30.
Figure 41 is a full and cut away view of a blood collecting
apparatus illustrated in Figure 40 showing the needle 21 fully
piercing sealing plug 51, with container turned 90° in a rotational
manner. The blood collection apparatus comprises blood collection
needle 21, needle holder 530, and container 40 with sealing plug 51
and shield 150. Sealing plug 51 is used to close container 40, having
at least one internal chamber 361 and diverter 373 for regulating,
diverting, re-directing, reducing, increasing or interrupting the
specimen flow through, into or within sealing plug 51 during blood
collection procedures. Recess 360 creates an inner channel or
passageway when sealing plug 51 is positioned in or within the open
end of container 40.
Shield 50 having a projection 52 for frictionally or rotationally
engaging needle holder 530 and internal projection 54. Projection 52
engages projection 54 during rotational or frictional movement of
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container 40 towards needle 21, maintaining a positive control
during sealing plug 51 puncture by needle 21. Direct axial removal
of container 40 is unrestricted due to the open faced configuration of
projection 54 of needle holder 530 whereby container 40 can be
removed from needle holder 530 by a straight pulling motion.
Figure 42 is a partial cut away view of a prior art blood
collection container 140 having a sealing plug 141 to maintain a sub-
atmospheric pressure within internal chamber 143. Container 140 is
normally comprised of either glass or shatter resistant plastic. The
major limitation of using plastic as the container body 140 is the
tendency of the collected blood to react unfavorably with the
elements contained in the plastic resin. The inside of the plastic tube
must be completely coated with an additional barrier or film to
achieve the same compatibility as the glass substrate. This adds
additional cost to the collection container.
Figure 43 is a cross sectional view of a collection container of
the present invention comprising a container 840 having piercable
sealing plug 33 to maintain a sub-atmospheric pressure within
internal chamber 843 and coating or film 49 on the outer surface of
container 840 to reduce shattering probability in the event container
840 is broken during manufacturing, storage or use. Coating or film
49 comprises a protective material, which bonds to the outside
surface of container 840. Coating or film 49 keeps collection
container 840 intact during manufacture, storage and use.
Coating or film 49 can include, but is not limited to, a
polymeric or elastomeric material which can also be applied or sized
by chemical, electrical or heat processes. Coating or film 49
maintains tube substrate in an integral fashion and houses specimen
safely within container 840 when container is dropped or crushed,
keeping the healthcare worker from being exposed to the blood or
bodily fluid specimen and keeping the workplace safe. Fiim or
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coating 49 is applicable to any and all collection containers disclosed
within this application.
The coating 49 may be applied to the external surface of the
container 840 by submerging the container in a bath of molten
polymer material and then cooling the container to solidity the
polymer onto the external surface. Alternatively, coating 49 may be
applied by spraying the molten polymer or other suitable material
onto the external surface of the container 840 and then cooling the
container. In lieu of using a molten polymer, a solvent based, ultra-
violet light curable. or air curable polymer may be used.
Figure 44 is a cross sectional view of a collection container of
the present invention comprising a container 840 having piercable
sealing plug 33 to maintain a sub-atmospheric pressure within
internal chamber 843 and a coating or film 149 on the outer surface
of container 840 extending over the juncture or interface where
sealing plug 33 and container 840 join together. Coating or film 149
improves vacuum retention within internal chamber 843 and alerts
healthcare worker if the seal has been tampered with if a tearing,
stretching, or other deforming indication is present on coating or
film 149 where vacuum could have been compromised.
Figure 45 is a cross sectional view of the present invention
comprising a container 840 having a sealing plug 33 to maintain a
sub-atmospheric pressure within internal chamber 843 and a coating,
film or label 249 over the juncture or interface where sealing plug 33
and container 840 join together. Coating, film or label 249 improves
vacuum retention within internal chamber 843 and alerts healthcare
worker if the seal has been tampered with if a tearing, stretching, or
other deforming indication is present on coating, film or label 249
where vacuum could have been compromised.
Figure 46 is a partial cut away view of a collection container of
the present invention comprising a container 40 having a sealing
plug 31 to maintain a sub-atmospheric pressure within internal
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chamber 43 and a sensor or probe 90 which is accessible from the
outside of container 40. Specimen can be analyzed without removal
of sealing plug 31 from container 40.
Figure 47 is a partial cross sectional view of a collection
container of the present invention comprising a container 40 having
a sealing plug 91 to maintain a sub-atmospheric pressure within
internal chamber 43 and a diverter 78, which can be comprised of a
dissolvable or undissolvable material, creating an intermediate
chamber 861 when attached to sealing plug 91, which re-directs
specimen flow entering chamber 861 towards the outer perimeter o
container 40. Diverter 78 is attached to sealing plug 91 by means of a
plurality of projections 85 which engage sealing plug 91 at recess 47.
Annular passageway 860 allows specimen flow to gravitate toward
perimeter of collection container 40, or to the lower extremity of
collection container 40 regardless of how container is positioned in a
needle holder. A 360° specimen diversion, or any fraction thereof, is
accomplished by diverter 78.
Diverter 78 is shown frictionally engaging recess 47 of sealing
plug 91 whereby gripping force is sufficient to maintain attachment
during the normal specimen collection procedure. All collected
specimens are placed in a centrifuge and spun to separate the plasma
from the red cells prior to testing. The gripping force of diverter 78
to sealing plug 91 is capable of releasing during the centrifuge
process. This allows any specimen which remained within
intermediate chamber 861 after the collection procedure to be
combined with the specimen in the internal chamber 43.
Diverter 78 can also comprise a hinged section whereby
diverting section is maintained in a diverting position during the
normal collection procedure and is opened by the centrifugal force
generated during the centrifuge process. This allows any specimen
remaining within intermediate chamber 861 to be combined with
the specimen in the internal chamber 43.
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Figure 48 is a partial cross sectional view of a collection
container of the present invention comprising a container 40 having
a sealing plug 91 to maintain a sub-atmospheric pressure within
internal chamber 43 and a diverter 178 with a well which creates
intermediate chamber 961 and re-directs a specimen flow entering
chamber 961 towards the outer perimeter of container 40. Diverter
178 is attached to sealing plug 91 by means of a plurality of
projections 85 which engage sealing plug 91 at recess 47. Diverter 178
having an aperture or channel 79 for draining specimen within
intermediate chamber 961 after collection.
Diverter 178 can be made of a dissolvable or undissolvable
material. Aperture 79 can include a dissolvable material which
blocks aperture 79 during the collection process and dissolves when
exposed to liquid, opening aperture 79 to allow any specimen
contained in chamber 961 to empty into container 40. Annular
passageway 960 allows specimen flow to gravitate toward perimeter
of container 40 or to lower extremity of collection container 40.
Figure 49 is a full side view of a diverter of the present
invention which engages a sealing plug and creates intermediate
chamber which re-directs specimen flow to the outer perimeter of a
collection container. Diverter 278 having a plurality of projections 85
and barbs 79 which engage a sealing plug.
Figure 50 is a full top view of the diverter shown in Figure 49
having a plurality of projections 85 and barbs 79 extending from
diverter 278.
Figure 51 is a cross sectional side view of a sealing plug of the
present invention comprising a piercable sealing plug 91 having at
least one recess 47 for engaging a separate component. Recess may be
annular, intermittent or the like to facilitate attachment of another
component to sealing plug 91.
Figure 52 is a full bottom view of the sealing plug shown in
Figure 51 in axis 52-52 having at least one recess 47 for engaging a
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separate component. Recess may be annular, intermittent or the like
to facilitate attachment of another component to sealing plug 91.
Figure 53 is a partial cross sectional view of a collection
container of the present invention comprising self-shielding sealing
plug 18 having an axially slidable shield 17 about one portion of
shielding plug 18 inserted in an openable end of container 40.
Puncturable sealing plug 18 having chamber 19 formed by diverter
13 for diverting specimen flow as it exits a needle, shown in other
drawings. Passageway 15 openly connecting chamber 19 with
internal chamber 43 of container 40.
Sealing plug 18 having an annular recess 27 for housing
annular projection 16 for maintaining shield 17 in slidable
engagement with sealing plug 18. Projection 16 is shown with
chamfered top which allows easy, self-centering assembly of sealing
plug 18 into shield 17 prior to insertion in openable end of container
40. Sealing plug and shield 17 comprise an air-tight seal to maintain
a sub-atmospheric pressure within collection container 40.
Figure 54 is a partial cross sectional view of the collection
container shown in Figure 53 with self-shielding sealing plug 18 and
axially slidable shield 17 removed from openable end of container 40
with shield 17 automatically shielding portion of sealing plug 18
which was in contact with specimen in container 40. Shield 17
closing port 15 at intersection 59 of shield 17 and sealing plug 18
safely containing any specimen remaining within chamber 19 of
sealing plug 18 from coming in contact with healthcare personnel.
Specimen remaining in chamber 19 is unlikely after centrifuging
container 40 with closed end of container 40 placed to the outer end
of centrifuge. Puncturable sealing plug 18 having chamber 19
formed by diverter 13 for diverting specimen flow as it exits needle
21, shown in other drawings, and passageway or port 15 in
communication with chamber 19 and internal chamber 43 of
collection container 40. Projection 1b of shield 17 limits axial
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movement of sealing plug 18 as collection container 40 is opened. It
is not necessary for shield 17 to close port 15 when shield 17 is
moved to a protective position., as long as outer wall of diverter 13 is
shielded by shield 17. Sealing plug and shield 17 comprise an air-
tight seal to maintain a sub-atmospheric pressure within collection
container 40.
When sealing plug 18 is removed from container 40, a greater
gripping force between container 40 inner wall and sliding shield 17
outer wall allow sealing plug 18 to slide first in an axial manner in
shield 17. Sealing plug 18 then is limited in axial movement within
shield 17 by projection 16 whereby continued axial force removes
both sealing plug 18 and shield 17 from openable end of container 40.
Figure 55 is a cross sectional view of a collection container of
the present invention comprising a translucent, flexible shield 250
and sealing plug 451 having a flow indicator or viewing area 99 to
determine specimen flow into chamber 461. Specimen flow is
diverted during the collection process by chamber 461 and diverter
473, and through passageway 460 into cavity 43 of container 40.
Since the container 40 and shield 250 are made of clear or
translucent materials, specimen flow is easily observed. Shield 250 is
not a necessary component whereby specimen flow is viewable
through clear container 40 wall when sealing plug 451 is used
individually. Flow Chamber 461 is easily manufactured by standard
injection or compression molding methods. It is preferable to have
shield 250 as clear as possible for easiest viewing of specimen flow.
Figure 56 is a cross sectional view of a collection container of
the present invention comprising container 40 with an internal
cavity 43, which may be evacuated, closed by sealing plug 37 with a
semi-circular outer perimeter allowing either end of container 40 to
be placed in a centrifuge. Tubular shield 350 having at least one
projection 28 for engaging at least one recess 44 of sealing plug 37.
Shield 350 has no top face and extends around the inserted sealing
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plug 37 with chamber 161 and diverter 173 to contain specimen
within sealing plug 37 and shield 350 when both are removed from
container 40. Recessed well 34 creates a smaller puncturable section
of sealing plug 37 for easy insertion of needle through sealing plug
37. Sealing plug 37 having a diverter 173, chamber 161 and
passageway 160 are connected with internal chamber 43 of container
40. Container 40 can include a closed end configuration having a
square, geometric, oval or other non-circular shape.
Figure 57 is a cross sectional view of a blood collection adapter
of the present invention comprising an extension or coupler 87
where a standard, or larger container 40, shown throughout this
application, is usable with smaller, pediatric needle holder 95, shown
in Figure 59. Smaller diameter needle holder 95 allows a shallower
angle to be used to access a blood vessel during blood collection
procedures.
A hollow bore needle, attached to smaller diameter needle
holder 95, is inserted into a blood vessel and sealing plug 88 end of
coupler 87 is inserted into needle holder 95. Cover 25 contains
specimen within chambers 46 and 93, and needle 421 until a larger
diameter collection container is slid into coupler 87 and sealing plug
of larger diameter container is pierced. A larger diameter collection
container can be used to collect a specimen using a smaller diameter
needle holder 95, shown in Figure 59. The smaller diameter needle
holder allows a shallower angle to be used to access a blood vessel
because the center point of needle holder 95 is closer to body surface
of the patient. Coupler 87 is attached to piercable cap 88 at interface
89. Smaller diameter sealing plug 48 having an external well 92 to
prevent residual specimen from coming in contact with healthcare
personnel during specimen collection and analysis.
Figure 58 is a cross sectional view of a blood collection adapter
of the present invention comprising an extension or coupler 187
with a flow regulating plug 48 where a standard, or larger collection
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container, shown throughout this application, is usable with smaller
diameter, pediatric needle holder 95. Plug 48 having chamber 94,
diverter 26 and passageway 36 created by inserting plug 48 into
coupler 187.
A hollow bore needle, attached to smaller diameter needle
holder 95, is inserted into a blood vessel and sealing plug 48 end of
coupler 187 is inserted into needle holder 95. Cover 25 contains
specimen within chambers 46 and 94 and needle 421 until a larger
diameter collection container is slid into coupler 187 and sealing
plug of a larger diameter container is pierced. A larger diameter
container 40 can be used to collect a specimen. using a smaller
diameter needle holder 95. Smaller diameter needle holder 95
allows a shallower angle to be used to access a blood vessel because
the center point of the needle is closer to body surface of the patient.
Smaller diameter sealing plug 88 having an external well 92 to
prevent residual specimen from coming in contact with healthcare
personnel during specimen collection and analysis. Sealing plug 48
can be removed after the specimen has been collected and the blood
contained in chamber 46 can be deposited onto a slide for visual
examination.
Figure 59 is a cross sectional view of a blood collecting
apparatus of the present invention comprising container 39 capable
of being used with either the standard needle holder, shown as a
needle holder, or smaller diameter, pediatric needle holder 95.
Smaller diameter needle holder 95 allows a shallower angle to be
used to access a blood vessel because the center point of needle is
closer to body surface of the patient. Smaller diameter sealing plug
98 having chamber 97, diverter 126, and passageway 96 for diverting
specimen exiting from needle 21 into container 39. Larger diameter,
opposite end of container 39 can be safely placed in a centrifuge to
separate red cells from the plasma. Smaller diameter sealing plug 98
having an external well 92 to prevent residual specimen from
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coming in contact with healthcare personnel during specimen
collection and analysis.
Larger diameter sealing plug 137 having chamber 161, diverter
173, and passageway 160 for diverting specimen exiting from a
needle into container 39. Larger diameter sealing plug 137 having an
external well 134 to prevent residual specimen from coming in
contact with healthcare personnel during specimen collection and
analysis. Container 39 can include just one open end whereby the
opposite end would be closed.
Figure 60 is a full side view of sealing plug of the present
invention having a channel 360 for equalizing the internal pressure
within the container with the ambient atmospheric pressure prior to
full removal of sealing plug 341 from a container. Chamfer 365 aids
assembly of sealing plug 341 into the open end of a collection
container.
Figure 61 is a full bottom view of the sealing plug shown in
Figure 60 having a channel 360 for equalizing the internal pressure
within the collection container with the ambient atmospheric
pressure prior to full removal of sealing plug 341 from a container.
Chamfer 365 aids assembly of sealing plug 341 into the open end of a
container.
Figure 62 is a cross sectional view of sealing plug shown in
Figures 60 and 61 with sealing plug 341 with channel 360 and
chamfered bottom 365 inserted into container 340. Channel 360 and
chamfered bottom 365 closing container 340 creating an internal
chamber 343.
Figure 63 is a cross sectional view of the sealing plug shown in
Figure 62 with a channel 360 and chamfered bottom 365, being
moved from a sealing position and equalizing the internal pressure
within the container 340 and chamber 343 with the ambient
atmospheric pressure prior to full removal of sealing plug 341 from
container 340. The equalization of internal pressure of chamber 343
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reduces exposure probability to specimen contained within container
340.
Figure 64 is a cross sectional side view of collection container
of the present invention being closed by removable sealing plug 441
with an externally accessible chamber 455 sealed by strip 475 with
pull tab 476. As a needle punctures sealing plug 441, hollow bore of
needle containing specimen enters chamber 455 depositing a small
amount of specimen within chamber 455. Specimen is collected in a
normal fashion into chamber 443. When needle is removed from
sealing plug 441, again a small amount of specimen is deposited
within chamber 455.
Container 440 does not have to be opened, or does sealing
plug 441 have to be punctured with a needle, or removed to obtain a
small amount of specimen for visual analysis.
It is dangerous to withdraw the needle uncovered and deposit
the collected specimen from the sharpened tip of the needle to a
slide. With the probability of the needle being covered immediately
upon withdrawal from a venipuncture site to prevent a needle stick
accident, this invention makes it possible to obtain a small amount
of collected specimen for a slide without exposing the healthcare
worker to a sharp needle with blood in or on it.
Chamber 455 can be coated with an anti-clotting agent, dye or
the like to facilitate visual examination of the specimen.
Figure 65 is a cross sectional side view of collection container
shown in Figure 64 being closed by removable sealing plug 441 with
an externally accessible chamber 455 being opened by removal of
strip 475 with pull tab 476. Specimen deposited in chamber 455 can
now be deposited onto a slide for visual examination.
Figure 66 is a full side view of a collection container of the
present invention with an externally accessible chamber 543 being
closed by separable and movable sealing plug 541, with a movable
external shield 550 having an aperture 575 closing container 540
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creating internal cavity 543. External shield 550 is in a first position
closing external access to chamber 555 of sealing plug 541.
Figure 67 is a full side view of a collection container shown in
Figure 66 being closed by removable sealing plug 541 with movable
external shield 550. Aperture 575 is now in a second position,
relative to the first movable position, exposing chamber 555
allowing access to collected specimen deposited within chamber 555
during collection procedures. Movement of shield 550, relative to
chamber 555 of sealing plug 541 can include a third position,
whereby aperture 575 would be locked in a closed position,
preventing external access to chamber 555.
Container 540 does not have to be opened to gain access to
collected specimen in internal cavity 543, nor does sealing plug 541
have to be punctured with a needle, or removed to obtain a small
amount of specimen for visual analysis.
Chamber 555 can be coated with an anti-clotting agent, dye or
the like to facilitate visual examination of the specimen.
Figure 68 is a cross sectional side view of the collection
container shown in Figure 66 having chamber 543 being closed by
removable sealing plug 541 with movable external shield 550 having
aperture 575 closing chamber 555 of sealing plug 541 at section 576.
External shield 550 is in a first position closing external access to
chamber 555 of sealing plug 541.
As a needle moves through well 544 and punctures sealing
plug 541, the hollow bore of the needle containing specimen enters
chamber 555 depositing a small amount of specimen within the
chamber. The needle then fully punctures the sealing plug 541 and
specimen is collected in a normal fashion into chamber 543. When
needle is removed from sealing plug 541, again a small amount of
- specimen is deposited within chamber 555.
Figure 69 is a cross sectional side view of the collection
container shown in Figure 67 having chamber 543 being closed by
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removable sealing plug 541 with movable external shield 550
aperture 575 in a second position exposing chamber 555 allowing
access to collected specimen deposited within chamber 555 during
collection procedures.
Container 540 does not have to be opened, or does sealing
plug 541 have to be punctured with a needle, or removed to obtain a
small amount of specimen for visual analysis.
A positive engagement means can position movable shield
550 in either a first closed position, or a second open position,
reducing the probability of movable shield 550 inadvertently
opening prematurely during the collection process.
A needle, with one sharpened tip for puncturing a sealing
plug of a filled collection container, and the other end exposed end
being blunted, can also be used to deposit a smear of blood on a slide.
The needle can be attachable to a needle holder described
throughout this application, or can be used individually to access a
collected specimen in a collection container.
Figure 70 is a cross sectional side view of the present
invention having a container with sealing plug which includes a
diffusing member. Sealing plug 1041 includes an external well 1044
and a porous member 1063 for diffusing a liquid entering internal
chamber 1043 of container 1040 during the collection process.
Sealing plug 1041 includes a chamfered bottom 1065 to facilitate
insertion into container 1040.
Figure 71 is a cross sectional side view of the container and
sealing plug shown in Figure 70 showing a specimen being diffused
during delivery into container 1040. Needle 1021 is attached in
needle holder 1030 and container 1040 is inserted in chamber 1035 of
needle holder 1030, allowing proximal end of needle 1023 to
puncture sealing plug 1041 and enter porous member 1063.
Specimen exits needle 1021 and is diffused during the collection
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process. Sealing plug 1041 includes a chamfered bottom 1065 to
facilitate insertion into container 1040.
Figure 72 is a cross sectional side view of the present
invention having a container with sealing plug which includes an
occluding member. Sealing plug 2041 includes an external well 2044,
an inner chamber 2061, a diverting section 2073 and an expandable,
liquid-sensitive section 2063 having an open aperture which allows
a liquid to pass through it, yet expands and closes within minutes
after being exposed to a liquid.
Figure 73 is a cross sectional side view of Figure 72 showing a
specimen contained within container 2040 and chamber 2061 of
sealing plug 2041 no longer being in fluid communication with
chamber 1043 of container 1040. Liquid-sensitive section 2063 is
swollen and the aperture closed.
Figure 74 is a cross sectional side view of the present
invention having a container with an existing prior art sealing plug
or sealing plug 1441 with an external well 1444 which includes a
diverting component 1478 having a chamber 1461 created by
inserting diverter 1478 into hollow end of sealing plug 1441.
Diverter 1478 having a closed end 1473, at least one open aperture
1460 and may include at least one projection 1479 for frictionally
engaging inner wall of sealing plug 141. Diverter 1478 may include a
chamfered closed end 1473 to allow specimen remaining in chamber
1461 to drain into chamber 1443 of container 1440 prior to, or during
centrifuging or analysis. Projection 1479 may be segmented or
circumferential to support wall section of sealing plug 1441, creating
an improved seal at the sealing plug/container surface interface,
thus reducing vacuum leakage and increasing the shelf life of the
vacuum tube.
Diverter end 1473 may include a large opening and be closed
by a removable or dissolvable wall section which allows the
specimen remaining in the intermediate chamber 1461 after
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collection to be added to the specimen in the collection container
chamber 1443. Specimen would still flow through aperture 1460
during the collection process. A dissolvable material, such as those
used as additives to facilitate analysis, maybe used and dissolve
within minutes of being wetted by a specimen. The diverting end
1473 would be removed from the diverter by the centrifugal forces
placed on the container during the centrifuge process. Thus any
specimen remaining in the intermediate chamber 1461 would be
added to the specimen in the collection container. This would allow
a long needle to freely access the specimen, which may be separated
into plasma and red cells during the centrifuge process, enabling a
pure plasma or red cell specimen to be drawn from the container for
analysis.
Diverter 1478 radially compresses sealing plug 1441 against
collection container 1440 wall, improving seal and increasing shelf
life of the container. The inner wall section of sealing plug 1441 may
include an annular or segmented undercut or projection to
correspondingly mate with a projection or undercut respectively, on
diverter 1478. An undercut or recess is easily moldable into
elastomeric materials like rubber or rubber mixed with plastic, or
other compounds.
The cost of implementing this flow diverting technology is
very low because existing tooling and components do not have to be
modified. The assembly procedure would have to be modified and
tools created for manufacturing the diverting component.
Figure 75 is a cross sectional side view of the present
invention having a container with an existing prior art sealing plug
with an annular member which frictionally engages the inner wall
section of sealing plug. The sealing plug wall section 3065 adjacent
to annular member 3079 is compressed and supports the wall section
3065 when the sealing plug 3041 is inserted in container 3040.
Annular member 3079 may be cylindrical in shape with open ends.
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Cylindrical configuration contacts a greater portion of sealing plug
wall section, creating more surface area of contact with collection
container wall. Annular member 3079 radially compresses sealing
plug against collection container wall, improving the seal and
increasing shelf life of the container.
The use of annular member 3079 provides an improved seal
at the sealing plug/container surface interface, reducing "gray band"
regions and vacuum leakage, thus increasing the shelf life of the
vacuum tube.
The cost of implementing this improved sealing technology is
very iow because existing tooling and components do not have to be
modified. The assembly procedure would have to be modified and
tools created for manufacturing the annular component.
Figure 76 is a cross sectional side view of the present
invention having a container with a sealing plug with a pressure
sensitive valve which is activated when a pressure difference exists
on either side of the valve. Sealing plug 4041, includes an external
well 4044 and projection or undercut 4062, which may have an
annular configuration, is inserted in container 4040 creating cavity
4043. Valve 4078 is positioned in sealing plug 4041 and creates
chamber 4061 which closes at interface 4075. When sealing plug 4041
is punctured by a needle and a greater pressure is created in chamber
4061, valve 4078 opens and the area of higher pressure moves to the
area of lower pressure contained in cavity 4043. Valve 4078 also has
a diverting section 4073.
Figure 77 is a full side view of the pressure sensitive diverter
or valve 4078 which is inserted in a sealing plug.
Figure 78 is a cross sectional side view of a sealing plug 5041
having a diverting component 5078 with an aperture 5060 for
diverting or regulating a specimen flow, a diverting wall section
5073, and a channel or slot 5000 for accessing a collected specimen in
a container sealed by sealing plug 5041. A long needle may be
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inserted through sealing plug 5041 to access the collected specimen
with out contacting any specimen which may be residing in the
chamber created by the coupling of sealing plug 5041 and diverter
5078.
Figure 79 is a partial cut away view of the diverting
component 5078 of Figure 78 shown in Axis 79-79. Diverting
component 5078 having a channel or slot 5000 and chamber created
by diverting wall section 5073.
Figure 80 is a full side view of a blood collection needle with a
manually activated needle guard. Blood collection needle having a
hub 6015, with a fixedly attached hollow bore needle 6010 with both
the proximal and distal ends sharpened, distal end 6011 is shown
here, with the proximal end covered by a puncturable boot or cover.
A needle guard 6022 is releasably held adjacent to hub 6015 by a
latching arm 6026 which includes a finger pad 6027 and a stop or
projection 6049. Needle guard 6022 having a needle trap 6041 which
rides on the needle and moves to a protecting position when needle
guard 6022 is manually released by activating the finger pad 6027.
Any longitudinal compressive force exerted by inserting needle 6010
into a patient does not activate needle guard 6022.
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