U.S. patent number 3,848,579 [Application Number 05/335,419] was granted by the patent office on 1974-11-19 for automatic elasto-valvular hypodermic sampling needle.
Invention is credited to Antony-Euclid Villa-Real.
United States Patent |
3,848,579 |
Villa-Real |
November 19, 1974 |
AUTOMATIC ELASTO-VALVULAR HYPODERMIC SAMPLING NEEDLE
Abstract
A novel blood-drawing device with automatically actuatable
elasto-valvular mechanism or component, sensitive to pressure
differential changes, attaining variable aperture sizes in the
opening phase aimed to reduce mechanical hemolysis of the red blood
cells and other cellular disintegration caused by high shear
forces, and, achieving a normally closed position to prevent blood
drip; a valve is situated between a pair of pre-formed internal
chambers or cavities that separate two axially arranged sharpened
cannulas; the device with a preferably transparent hub for visual
indication of the functional capabilities of the device, the hub
transparency being important during effective extraction of
singular as well as several separate fluid samples such as venous
blood collectible into one or more evacuated sample tubes,
respectively, during a single venipuncture; such device packaged in
sterile condition and made to be disposable after a singular
use.
Inventors: |
Villa-Real; Antony-Euclid
(Baltimore, MD) |
Family
ID: |
23311697 |
Appl.
No.: |
05/335,419 |
Filed: |
February 23, 1973 |
Current U.S.
Class: |
600/577; 604/237;
600/579 |
Current CPC
Class: |
A61B
5/1545 (20130101); A61B 5/15003 (20130101); A61B
5/15048 (20130101); A61B 5/150221 (20130101); A61B
5/150732 (20130101); A61B 5/150946 (20130101); A61B
5/150404 (20130101); A61B 5/150496 (20130101); A61B
5/150488 (20130101); A61B 5/150511 (20130101); A61B
5/150519 (20130101) |
Current International
Class: |
A61B
5/15 (20060101); A61b 005/14 (); A61m 005/32 () |
Field of
Search: |
;128/2F,DIG.5,214R,214.4,221,218N,35V,274,218NV,276
;137/525,525.1,525.3 ;251/120,121 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1,278,387 |
|
Oct 1961 |
|
FR |
|
129,280 |
|
Jul 1932 |
|
DD |
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: McGowan; J. C.
Claims
I claim:
1. In combination, a blood specimen collection assembly comprising
a hallow hub means, a resilient valve, a first hollow cannula and a
second hollow cannula, both of said cannulas fixed axially in
relation to each other as well as in relation to the center of the
said valve by the said hub means, and wherein the first said
cannula having a pointed end being for the purpose of puncturing
the skin and the blood vessel wall, and wherein the said second
cannula having a pointed end being for the purpose of piercing the
rubber stopper of the evacuated specimen collection receptacle to
establish communication between the said assembly and the vacuum of
the said evacuated specimen collection receptacle, a first cavity
and a second cavity, both of the said cavities located interiorly
of the said hub means, said hollow first cannula communicating with
the said first cavity providing a fluid inlet, and, said second
cannula being also hollow and communicating with the said second
cavity providing a fluid outlet, said valve situated therebetween
the said first and second cavities, said valve having a
cross-section that is thickest at the outward portion and thinner
at the inward portion and particularly thinnest at the central part
making the said valve structurally sensitive to the relevant
pressure differential changes focussed at and immediately around
the said central part of the said valve, said valve in
cross-section describing an inclined arc-like convexity toward the
first cavity at its foreface proximal to the said first cavity,
and, said valve defining an inclined arc-like concavity toward said
second cavity at its hind-face proximal to the said rear cavity,
the combination of both the said inclined arc-like convexity and
concavity being formed from the outer section of the said valve
toward the said valve's central part with a taper of the said valve
toward the said valve's center, said valve provided with a
plurality of cuts across its central part and said cuts converging
toward and intersecting the said valve' s center defining a
plurality of said cross sections; said valve held in stationary
position at its outer border by the inner portion of the said hub
means; said valve normally in the closed position when the said
assembly is not properly engaged with a potent evacuated specimen
collection receptacle and not properly linked with an active vein;
said valve being in a minutely semi-open position as far as air
transit from the said first cavity to the said aft cavity is
concerned when the said first cannula is in communication with the
kinetically flowing venous blood running through the venous lumen
of the properly penetrated vein thus allowing blood transport from
the venous side into the said fore cavity, but, said valve, after
air transit across its minutely widened cuts not permitting the
viscous blood to transfer across said valve into the said second
cavity and into the said evacutated receptacle until a
substantially potent aspirating force triggers the said valve to
the actually open position so as to allow the blood specimen
collection through the said assembly into the said aspirating
receptacle, said valve in the open position achieving gradual
variation in aperture sizes directly proportional to the degree of
pressure difference between the venous pressure and the aspirating
negative pressure of the said communicated evacuated specimen
collection receptacle so that in effect the said valve serves as a
compensatory shock absorber automatically decreasing the undesired
effects of high shear forces that predisposes the red blood cells
to mechanical hemolysis using the evacuated receptacle as a means
of blood specimen extraction.
2. The construction according to claim 1 wherein the said hub means
is made of metal.
3. The construction according to claim 1 wherein the said hub means
is made of rigid transparent plastic so as to allow visibility of
the passage of blood into the said fore cavity from the venous side
as a positive indicating means favorable for the operator before
prematurely communicating the valuable vacuum of the said evacuated
specimen collection receptacle with the said assembly; such
visibility through the structure of the said hub means also
providing an accurate checking means for the operator in observing
the functional property of the said valve in inhibiting blood flow
across said valve when no evacuated specimen collection receptacle
is installed with the said assembly as well as in observing the
blood transfer across said valve's open port from the said first
cavity into the said second cavity as soon as a potent evacuated
specimen collection receptacle has been properly linked with the
said assembly.
4. The construction according to claim 1 wherein the pointed end of
said first hollow cannula has a bevel.
5. The construction according to claim 1 wherein the pointed end of
said second hollow cannula has a bevel.
6. The construction according to claim 1 wherein the said hub means
is made of two pre-fabricated longitudinal halves strongly fused
together along their pre-set alignable borders.
7. The construction according to claim 1 wherein the said hub means
is made of two pre-fabricated cross sectional halves strongly fused
together by sonic technique of plastic fusion along the said
pre-fabricated halves' pre-set alignable borders.
8. The construction according to claim 1 wherein the said hub means
is partly made of transparent rigid plastic material surrounding
the said first cavity, and said hub means partly made of
non-transparent material surrounding the said second cavity.
9. The construction according to claim 1 wherein the said valve is
provided with a pin-hole at the said valve's center so as to allow
easy passage of air molecules from the said first cavity into the
said second cavity as blood from the venous side is transported
into the said front cavity via the said hollow cannula.
10. A blood collection device having a rigid, hollow hub means, a
first hollow cannula having a pointed end for the purpose of
puncturing the skin and the blood vessel wall, a second hollow
cannula having a pointed end for the purpose of piercing the rubber
stopper of a potent evacuated specimen collection tube, first and
second cavities in said hub means with a resilient valve situated
therebetween, said first and second cannulas separated by the said
first and second cavities as well as by the said valve, said first
and second cavities including said valve found within the inner
framework of said hub means which is made out of two pre-fabricated
hub parts fused tightly and strongly together around their
respective alignable rim, said first and second cavities
respectively having a fluid inlet and a fluid outlet and also
respectively communicating with the bore of the said first hollow
cannula and with the bore of the said second hollow cannula, said
valve held in stationary position therearound its outer border by
the inner structure of the said fused hub means, said valve having
at least a pair of equally dimensional slits running across the
said valve center, and, in cross-section, said valve having the
outer portion the thickest surrounding a thinner inner section
including a particularly thinnest control part thereby structurally
enhancing better reactive sensitivity of the said valve to the
pre-calculated pertinent pressure differential changes at and
immediately surrounding the said central part of the said valve,
said valve in cross-section defining an inclined arc-like convexity
toward said first cavity at its foreface proximal to the said first
cavity, and said valve in cross-section describing an inclined
arc-like concave configuration toward said second cavity at its
hind face proximal to the said second cavity, and jointly both said
inclined arc-like convexity and concave configuration being
structurally formed from the outer part of the said valve toward
the said valve central part and being tapered toward its center,
said valve capable of attaining three positions, a normally closed
position, a minutely semi-open position, and an open position, said
normally closed position being achieved when the said device is not
in use and when the said second hollow cannula is not properly
engaged with a potent aspirating evacuated specimen collection
receptacle and the said first hollow cannula is not correctly
linked with a potent, good sized vein, said minutely semi-open
position achievable during displacement of air from the said first
cavity into the said second cavity due to the entrance of the
viscous blood from the venous side after the said first cavity lets
the more positively pressured blood from the said venous side enter
side and said first cavity's lesser-positive pressured previously
air-filled space when the said first hollow cannula with its
pointed end establishes proper fluid communication with an active
good sized vein and while the said second hollow cannula with its
pointed end has not yet made the penetration through the rubber
stopper of a potent evacuated specimen collection receptacle and
therefore has not yet linked the vacuum of the said evacuated
rectptacle with the said device, the open position of the said
valve achievable as soon as the vacuum of the said evacuated
receptacle has been linked with the said device wherein the said
second hollow cannula with its pointed end has made the correct
penetration through the rubber stopper of the said evccuated
recptacle while the said second hollow cannula with it pointed end
being already linked with the properly penetrated active vein, said
valve being capable of achieving gradations in aperture sizes in
direct proportion to the degree of pressure differential between
the said venous blood source and the vacuum of the said evacuated
receptacle thereby favoring the decrease in occurrence of
mechanical hemolysis by reducing the ill effects of high shear
forces upon the flowing red blood cells during the aspiration
phase.
11. The construction according to claim 10 wherein the hub means is
made of rigid clear plastic material to allow visibility through
the said hub means.
12. The construction according to claim 10 wherein the hub means is
made of metal.
13. The construction according to claim 10 wherein the said hub
means is made partly transparent surrounding the said first cavity,
and said hub means made partly non-transparent surrounding the said
second cavity.
14. The construction according to claim 10 wherein the pointed end
of said frist hollow cannula has a bevel.
15. The construction according to claim 10 wherein the said second
hollow cannula is provided with at least one lateral opening.
16. The construction according to claim 10 wherein the pointed end
of said second hollow cannula has a bevel.
17. The construction according to claim 10 wherein the said hub
means is made of two pre-fabricated longitudinal halves.
18. The constructin according to claim 10 wherein the said hub
means is made of fused cross-sectional halves.
19. The construction according to claim 10 wherein the said device
is effectively utilizable in both the singular sampling and
poly-sampling of blood specimen from the vein without resulting in
messy blood drip into the ambient environment.
20. An effective hypodermic needle asembly applicable for use in
both singular sampling and poly-sampling of blood specimen from the
vein utilizing the evacuated specimen collection tube, firstly for
the purpose of preventing the messy blood drip into the ambient
environment during the process of blood extraction, secondly for
the purpose of diminishing the mechanical hemolyzing effects of
high shear forces upon the flowing red blood cells during the
aspiration phase, and thirdly for the purpose of preventing the
undesired premature exposure of the vacuum of the evacuated
specimen collection tube; said assembly comprising, in combination,
a rigid, hollow hub means internally having first and second
chambers that are axially aligned with each other, a resilient
valve therebetween said first and second chambers, a first hollow
cannula with a pointed end for the purpose of puncturing the skin
and the blood vessel wall, said first cannula axially fixed at its
other end by a first section of the said hub means, said first
cannula having communication with the said first chamber thereby
providing a fluid inlet, a second hollow cannula with a pointed end
for the purpose of piercing the diaphragm of the rubber stopper of
the evacuated specimen collection tube, said second cannula axially
fixed at its other end by a second section of the said hub means,
said second cannula having communication with the said second
chamber thereby providing a fluid outlet, said valve having a
cross-section that is thickest at the outward portion and thinner
at the inner portion and particularly thinnest at the central part
making the said valve structurally sensitive to the relevant
pressure differential changes focussed at and immediately around
the said central part of the said valve; said valve in
cross-section describing an inclined arc-like convexity toward said
first chamber at its foreface proximal to the said first chamber,
and, said valve in cross-section defining an inclined arc-like
concavity toward said second chamber at its hind-face proximal to
the said second chamber, the combination of the two said inclined
arc-like convexity and concavity being formed from the outer
section of the said valve toward the said valve's central part and
being tapered toward the said valve's center, said valve provided
with at least two equidistantly dimensioned centerly criss-crossing
slits cutting the central part of the said valve and forming at
least four said inclined arc-like concavity and convexity portions;
said valve held in stationary position at its outer border by the
inner framework of the said hub means; said valve normally in the
closed position when not in use and when no evacuated specimen
collection tube is installed with the said assembly, but said valve
responding to two sets of conditions, the first condition wherein
the said valve responds by achieving a brief semi-open position
during the initial entrance of the said pointed end of the said
first hollow cannula inside the lumen of the penetrated active
good-sized vein thus displacing the gaseous content previously
occupying the said first chamber by the incoming viscous blood via
the bore of the said first cannula, said gaseous content in the
form of air passing through the minutely widened said slits of the
said valve, the second condition wherein the said valve achieves a
gradation of varying apertural sizes while the potent evacuated
specimen collection tube is aspirating specimen from the already
linked vein, said varying apertural sizes of the said valve
directly proportional to the pressure differential between the
venous side and the aspirating capacity of the vacuum of the said
evacuated specimen collection tube per unit time; said hub made of
transparent plastic material to allow visibility therethrough as a
positive checking means to observe the functioning of the said
valve relevant to the flow of blood firstly into the said fore
chamber before linking the vacuum of the said evacuated specimen
collection tube, and then to observe the facileness of the said
valve in letting blood flow across its open port into the said aft
chamber when the potent evacuated specimen collection tube has been
installed with the said assembly linked with the said vein.
21. The construction according to claim 20 wherein the pointed end
of said first cannula has a bevel.
22. The construction according to claim 20 wherein the pointed end
of said second cannula has a bevel.
23. The construction according to claim 20 wherein the said second
cannula at least has one lateral opening near the pointed end of
the said second cannula.
24. The construction according to claim 20 wherein the said
valvular slits are straight as viewed from the end view.
25. The construction according to claim 20 wherein the said
valvular slits are of curved configuration as viewed from the front
view.
26. The construction according to claim 20 wherein the said hub
means is made of two pre-fabricated longitudinal halves fused
firmly together along their alignable rims.
27. The construction according to claim 20 wherein the said hub
means is made of two pre-fabricated cross-sectional halves fused
firmly together by sonic means along their alignable borders.
28. In combination, a blood extraction device comprising a hollow
hub means having first and second cavities interiorly and with a
resilient valve situated therebetween said cavities, a first hollow
bevel-ended cannula having fluid communication with the said first
cavity providing an inlet, a second hollow bevel-ended cannula with
fluid communication with the said second cavity providing an
outlet, said first and second cannulas axially fixed at their other
ends by the respective axially opposite portions of the said hub
means, said valve having a central H-shaped slit cutting across the
said valve's thickness, said valve having a cross-section through
the center of the H-shaped slit that is has been inserted.
29. The construction according to claim 28 wherein the said hub
means is made of transparent plastic.
30. The construction according to claim 28 wherein the said hub
means is made of two pre-fabricated longitudinal halves fused
strongly together along their alignable margins.
31. The construction according to claim 28 wherein the said hub
means is made of two pre-fabricated cross-sectional halves fused
together along their respective alignable borders.
Description
BACKGROUND OF THE INVENTION
Before proceeding into the depths of the historical background of
the invention, it is imperative that the essentials of the
VACUTAINER SYSTEM of blood-drawing be substantially explained in
order that clarification on the subject may be better achieved.
Fundamentally, the VACTAINER SYSTEM requires the following basic
items:
1. One or more VACUTAINER tubes. Each tube is a self-aspirating
specimen collector and container that is generally made of
transparent glass. One end of the tube is closed by the glass
structure itself, while the other end is plugged by a flanged
rubber stopper. Each VACUTAINER tube had been preevacuated of its
internal gaseous contents so that we can refer to it as a
pre-evacuated sample tube. It is, considerably, physically empty,
and that this condition creates a favorably effective negativity of
pressure which provides the VACUTAINER tube with an excellent power
for aspirating fluidic specimens such as blood samples when used in
coordination with the aforementioned VACUTAINER SYSTEM.
2. A VACUTAINER HOLDER which is preferably constructed of rigid
plastic material, having a tubular shape, open at its entrant end,
and, accommodating within the tubular limits of its internal
diameter the external circular borders of even the largest
utilizable VACUTAINER tube used for this particular purpose. Each
collecting tube can slidably be engaged or disengaged, one at a
time, within the tubular extent of the barreled holder, allowing
each vial to be inter-connected with, or disconnected from the hind
portion of the cannula. The other end of the VACUTAINER HOLDER
provides a closure with a central external enlargement having an
axially running screw threaded bore that furnishes a suitable means
through which the correspondingly adaptable screw form part of the
axially alignable hypodermic needle can be firmly attached.
3. A hypodermic needle that has two beveled ends--the forward
beveled end and the rearward beveled end; the former having been
designed for the purpose of puncturing the skin and the immediate
underlying tissues including the vein, and the latter, utilizable
for the penetration of the diaphragmatic area of the rubber stopper
that plugs each VACUTAINER tube. With this arrangement, it follows
that, after the forward beveled end has made the correct
penetartion of the vein, and the rearward beveled end had
completely pierced the diaphragm of the said rubber stopper, a
resultant physical continuity is created between the flowing venous
blood on one side, and the aspirating vacuum on the opposite side
through the common bore of the cannula. This is the reason why the
blood specimen gets collected into the VACUTAINER tube, sourced
from the venous side.
4. A fluid source such as venous blood source with which the
hypodermic needle is connected in relation to the evacuated sample
tube.
When the VACUTAINER SYSTEM for blood specimen extraction was first
introduced in the field of Laboratory Medicine, the applicable
hypodermic needles used during that time were not equipped with
structural and functional means of controlling the blood flow from
the vein through each hypodermic needle. This situation caused some
unavoidable blood drip or spatter during inter-tubular substitution
due to the fact that within such span of time when one collection
tube was disengaged from its connection with the hypodermic needle
and then replaced by the next preevacuated sample tube in line, the
absence of a blocking factor that could have prevented the
bore-continuity between the venous side and the ambient
environment, propagated the inter-linkage of the pressure
differential existing between the venous side and the ambient
condition. This was because the hypodermic needle was still
connected with the vein during the process of inter-tubular
changing as in the case of multi-sampling of blood with a single
venipuncture. Some quantities of dripping blood used to accummulate
at the basal sector of the plastic VACUTAINER HOLDER. Moreover, due
to the physical motions relevant to the many entries and exits of
the plurality of collection tubes, each one being individually
engaged into and then disengaged out of the plastic VACUTAINER
HOLDER, the accummulated blood inside the holder's barrel were
oftentimes spilled out, messing the patient's or donor's arm,
clothing or even the hospital bed linens.
In the latter part of the 1960s, Becton, Dickinson and Company of
Rutherford, N.J. introduced a modified version of the said
hypodermic needle, an improved kind which was designed more
specifically for multi-sample collection of blood specimens. This
hypodermic needle has a tubular rubber sleeve that snugly fits
around the hind portion of the cannula. This sleeve envelops the
external area of that said portion of the cannula and covering the
laterally situated hole found just a little measure from the
hindmost piercing portion of the device.
During the filling phase, the lateral hole is uncovered by the
rubber sleeve that has been pushed forward by the rubber stopper of
the VACUTAINER tube. Hence the said lateral hole comes in direct
communication with the vein through the common bore of the cannula,
thereby, blood is aspirated automatically into the connected
collection tube. However, when the desired amount of specimen has
been collected into the said tube, and such vial has now been
pulled away from its needle connection, the temporarily compressed
rubber sleeve springs back to attain its orriginal lengthwise
hole-covering position. As a result, it becomes evident that during
the time span existing between intertubular replacement, the
lateral hole becomes actually plugged from exposure to the ambient
environment. Because of this feature, the blood drip is prevented
from occurring during the process of multi-sampling of blood
involving a single venipuncture.
Recently, Becton, Dickinson and Company made another modification
of their MULTIPLE-SAMPLE HYPODERMIC NEEDLE centering the innovative
drip-preventing feature mainly by altering the design of the rubber
sleeve as well as the location of the hole that must communicate
with the vacuum of the collection tube. This latest version has a
rubber sleeve that is closed at its rearward end; such rubber
closure part of the said sleeve covers the now axially located
hole, and that, such closure comprising of rubber material is
thinly constructed and easily puncturable by the hind beveled part
of the cannula. Relatively, however, the governing principle
involved in this version is about the same as compared to that of
the preceding version.
Although the two improved versions are capable of preventing the
undesired blood drip, there is an inherent chief disadvantage:
There is a considerable resistance exerted by the tubular rubber
sleeve against the forwardly pushed ramming mass of rubber stopper
of the collection tube. The only way this resisting force of the
said tubular rubber sleeve could be overcome is by pushing
comparatively harder at the base of the collection tube with the
thumb or with the palm of the hand, and then, maintaining that firm
pushing action to prevent the rebound of the temporarily compressed
elastic tubular sleeve. If this firm push at the base of the said
tube is not maintained, there arises a danger of displacing the
rubber stopper a bit rearwards, a condition which may bring forth
blocking of the cannular hole that communicates with the vacuum of
the collection tube, and then resultant inhibition of blood flow
into the collecting vial could happen thereby interrupting the
process of blood sampling. Even though it can be argued that, in
the performance of such mechanical manipulation, the operator can
adjust to the additional manual requirement, still, from the
viewpoint of ease of operation, the aforementioned hypodermic
needles produced by Becton, Dickinson and Company can be considered
crude to operate. Additionally, granting that the other hand can
aid the manipulation in an effort to stabilize the needle's
position intravenously, the extra-strenous requirement may possibly
alter the optimal location of the said needle in relation to the
said vein. Aside from this, the initial quick forward push exerted
upon the VACUTAINER tube in order to effectively compress the
elastic tubular structure of the rubber sleeve so as to shrink its
lengthwise occupancy of the exterior surfaces of the hind portion
of the cannula, may be inefficiently transmitted to the forward
beveled end of the hypodermic needle; such undesired
force-transmission when not effectively balanced by a corresponding
magnitude of counter-force exerted by the other hand, may
essentially cause a dual venous-wall puncturing, culminating to a
greater injury upon the somatic constitution of the blood vessel
including the immediate surrounding tissues.
Lately, there is another kind of multi-sample hypodermic needle
produced by MPL called QUICK-DRAW. Its ruling feature is the use of
a two-part cannula--the front-part cannula which is stationary, and
the rear-part cannula which can slide back and forth in a
longitudinally directed fashion, thereby providing a means to
effect an inter-cannular bore physical engagement or disengagement
as the longitudinally movable rear cannula's frontal section
alternately pierces and unpierces an intermediary rubber plate at
the central site of the said plate's material break. Once the
beveled section of the front-part cannula has made the right venous
penetration and has been correctly positioned inside the lumen of
the vein, the rear-part cannula is then pushed forward slideably by
the mass of the forwardly directed rubber stopper of the VACUTAINER
tube. As a result, the frontal sector of the rear-part cannula
pierces the intermediary rubber plate at its material break. This
situation brings forth a resultant blood flow from the venous side
propagated through the cannular bores of both the front-part and
the rear-part cannulas soon as the rubber stopper of the said tube
has been substantially penetrated by the rearward beveled edge of
the rear-part cannula. Having thus achieved a physical continuity
between the venous side and the vacuum of the collecting vial,
blood specimen is then transported into the said container.
Afterwards, as the blood-filled tube in withrawn from its
connection with the rear-part cannula, the movable feature of such
rear cannular part this time enables it to move along the rearward
direction of the now-being-disengaged rubber stopper while still
being pierced by that rear cannular part, until the rearmost
slideability limitations of the rear-part cannulas has been
reached, at which point, the rubber plate becomes completely
unpierced by the said frontal sector of that rear-part cannula, and
that, the material break of the rubber plate attains its normally
close position, thus blocking blood flow from the venous side. This
is how blood drip is prevented during intertubular replacement of
collection tubes.
Despite the fact that the principle of operation of the QUICK-DRAW
HYPODERMIC NEEDLE has deviated from the use of the rubber sleeve
which causes the disadvantages mentioned before the device poses
another type of inferiority because of its unstable functional
feature derived from the manually operable movable rear-part
cannula. Its instability during the course of multi-sampling,
somehow negatively affects the dexterity of the operator, and, such
a device pre-disposes the blood sample to a greater danger of
cellular destruction as an after-effect of the slideability of the
rear-part cannula due to the mechanical impact between the said
rear-part cannula and the other component structures of the device,
while blood is being transported through such medium.
From the point-of-view of analytical relativistics involving the
governing principles of the correlative link between the in-vivo
and in-vitro hemodynamics occurring during multi-sampling, to
actual utilization of the constant aperture size characteristics of
both the Becton-Dickinson and the MPL types of hypodermic needles,
clearly reveal the lack of structural adaptability in reducing the
detrimental high shear forces encountered during the initial
filling phase. On the basis of this finding, the use of those
hypodermic needle versions pre-disposes the blood specimen to a
higher degree of hemolysis and other cellular disintegration
constituting an inevitable disadvantageous aftermath.
The above-mentioned hypodermic needle versions are not equipped
with any visual indicator which would enable the operator to
correctly determine whether or not the desired blood flow from the
vein through the cannula had already ensued. The absence of such a
visual indicator will, at times, result in a trial-and-error
premature exposure of the vacuum contained within the collection
tube. Since the aspirating power of the VACUTAINER tube is directly
proportional to the degree of vacuum or negativity of pressure
contained therein, the improper location or wrong angular
positioning of the front beveled end of the hypodermic needle in
relation to the actual lumen of the vein can result in some loss of
the pre-evacuted vial's aspirating power.
BRIEF SUMMARY OF THE INVENTION
This invention pertains to a novel blood-drawing device
particularly utilizable for the effective extraction of either
singular volume or several quantities of separate blood samples
collectible into one or more evacuated sample tubes, respectively,
and achieving an advantageous reduction of mechanical hemolysis of
the red blood cells as well as possibly decreasing the danger of
disintegration of other cellular elements suspended in the plasma
caused by high shear forces in conjunction with the use of
pre-evacuated sample tubes, and, at the same time allowing the
convenient multi-sampling of blood, attainable with a single
venipuncture and without resulting in blood drip or spatter; said
new device provided with a built-in automatically actuateable
elasto-valvular mechanism or component with special configurations
and other valvular characteristics and properties pre-tested to
achieve gradations of reactive sensitivity to pressure differential
changes that trigger, in a much more automatic fashion, the opening
and closing responses of such valve; said elasto-valvular component
situated in between a pair of internal chambers or pre-formed
cavities that separate the longitudinally aligned pair of front and
rear cannulas--the front cannula utilizable for the penetration of
the relevant bodily tissues for the purpose of establishing a
physical connection with the venous blood source or other fluid
sources, and, the rear cannula aimed for the proper puncturing of
the rubber stopper plugging each evacuated sample tube, thereby
providing means for communication between the said evacuated sample
tube and the internal parts of the said device, as well as
affording a physical continuum with the venous blood source; said
pair of chambers or cavitations called the fore and the aft
cavities are within the internal confines of a strong and rigid and
preferably transparent plastic hub means, holding the stationary
margins of the said elasto-valvular component firmly in place, and,
at the same time, such hub means fixing the inner portions of the
front and the rear cannulas in an inflexibly and straightly aligned
position; said front and rear cannulas preferably made of metallic
composition, described as stationary with respect to their
attachements with the hub means, such front and rear cannulas
having bore diametric dimensions less than the diametric dimensions
of both the fore and aft cavities; said elasto-valvular mechanism
or component attaining variability in valvular apertural sizes
during the opening phase of the said device to enhance an
adjustable means of reducing the stressful high shear forces
inherently encountered during the use of evacuated sample tubes,
and, with the provision of the streamlined edges characterizing the
elasto-valvular component's valvular configurations through which
or around which blood rushes, cell destruction of the red blood
cells, the white blood cells and possibly the platelets, are
considerably reduced. The aperture sizes of the valve are relative
to the degree of pressure diffferentials between the venous blood
source and the aspirating evacuated sample tube in correspondingly
direct proportionality to one another in each pair of conditions,
after the initial opening peak has been achieved. In the normally
closed position, the said elasto-valvular mechanism achieves its
efficient role in preventing the transport of the blood quantities
across it due to the inherent pre-calculated structural stiffness
of the valve itself, resisting the opening of such valve means when
the pressure differential is weak enough to act against the
resisting valvular stiffness. As for example, a considered weak
pressure differential that cannot open the valve is the pressure
differential existing between the pre-calculated range of venous
pressures varying from individual to individual, and, the range of
allowable atmospheric pressures varying according to depth as well
as height relative to sea level pressure. This feature, therefore,
positively prevents the occurrence of blood drip from the venous
side into the ambient environment while the needle is connected
with the lumen of the said vein; such prevention of blood drip
being specifically important firstly prior to the installation of
the initial pre-evacuated sample tube, and secondly during the span
of time while changing one blood-filled tube with another unused
one until several tubes, in sequential order, have collected the
necessary amounts of separate quantities of blood specimens during
the process of multi-sampling involving s single venipuncture. This
new type of hypodermic needle being provided with a preferably
transparent hub for visual indication purposes; said device having
certain finger-grippable exterior surface contours for its easy
installation and disengagement with the corresponding inter-linking
part of the VACUTAINER TUBE HOLDER; said device having a rear
externally threaded screw form or other locking means adaptable to
firmly link it, in a stable fashion, with the VACUTAINER TUBE
HOLDER; said device being simple in construction can be
economically mass-producible; said device attaining medical
praiseworthiness through the maintenance of a clinically
pre-sterilized condition in packaging; said device to be made
disposable after a single use to avoid cross-contamination.
Basing on the preceding descriptions of this novel device centered
upon its unique structural construction and functional capabilities
abiding with the sound principles of Biophysics and Design
Engineering, the following objects of the present invention are
hereby discussed:
One object is to avail several designs or models of the new kind of
hypodermic needle, which by virtue of the advantangeous structural
designs and detailed internal configurations would facilitate the
drawing of singular sample as well as multisample collection of
blood specimens to be contained into a plurality of VACUTAINER
tubes, offering a relative ease on the performance of the
technologist, technician, nurse or physician during the execution
of the proper method of intra-tubular blood specimen filling.
Another object is the provision of a novel means to effect an
automatic blood specimen flow and control of such flow within the
said device by the use of a built-in elasto-valvular mechanism or
component that can bring forth the efficient inter-tubular
substitution of VACUTAINER tubes during multi-sample collection of
said specimens without blood drip or spatter.
From the biophysical viewpoint, another object is to procure a much
more adaptable device characterized by having a better capability
of achieving a more flexible range and degree of aperture size
variability as effected by the proper functional responses of the
elasto-valvular component relative to the pressure differential
gradients existing between the venous pressure on one side and the
aspirating vacuum of the VACUTAINER tube, on the other side. This
actuateable variability in aperture size accomplished in a more
streamlined and automatic fashion, will greatly eliminate the
hemolysis of red blood cells as well as possibly prevent the
disintegration of other cellular elements suspended in the plasma
during the whole blood's passage through the poly-sample hypodermic
needle.
A further object is to endure a greater possibility of diminishing
the occurrence of venous wall collapse that happens more
predominatly with the use of the currently manufactured hypodermic
needles applicable to the VACUTAINER SYSTEM of drawing blood.
Again, from the biophysical standpoint, this object may be carried
out well because of the gradual opening characteristics of the
elasto-valvular component during the first phase of
vacuum-triggered fluidic-mass transport of the blood volume from
the vein into the aspirating system, thus affording a less abrupt
shock-wave propagation as compared to the constant aperture size of
the current hypodermic needles that do not have a shock-absorbing
mechanism.
Another object, specifically those designs that are each made of a
transparent hub or main supporting part, is to provide the operator
with some visual means inherent in their structural constitutions
so as for him to effectively tell whether or not the favorable
blood flow from the vein has already ensued through the front
cannula and into the fore cavity of the main supporting part before
he exposes the vacuum of the first VACUTAINER tube. This feature
would prevent the premature exposure of the negativity of pressure
of the said first collecting container. With the transparency of
the main supporting part, moreover, it would permit the operator's
visual knowledge about the functional efficiency of the
elasto-valvuar mechanism during the collection of blood
samples.
Still a further object is to present a more-superior hypodermic
needle in the light of enhancing greater automaticity of operation
while offering a steadier device to handle as compared to the other
hypodermic needles used in the field. This advantage highly
diminishes the patient's or donor's pre-disposition to the
multilating physical injuries to the venous wall and the
surrounding tissues that result in unsightly extravasation of
blood, a condition which is sometimes encountered more prevalently
and in a more extensive degree with the utulization of the cruder,
in fact, partially mechanically manipulated inferior hypodermic
needles used these days.
BRIEF DESCRIPTIONS OF ILLUSTRATIVE DRAWINGS
In accordance with the primary and secondary aims of the present
invention as a more superior innovation over the currently used
ones, reference is made to the accompanying illustrative
embodiments in the form of the following sequence of drawings that
are labeled with specific numerals, letters, and numeral-letter
combinations from which a more in-depth and thorough understanding
of the novel features and advantages will be apparent. In the
drawings:
FIG. 1 is an enlarged longitudinal section of Model A of the
invention.
FIG. 2 is an enlarged longitudinal section of Model B of the
invention.
FIG. 3 is an enlarged longitudinal section of Model C of the
invention.
FIG. 4 is a more magnified longitudinal section in fragmentary form
centering on the middle fundamental components of the Model A of
the invention.
FIG. 5 is another more magnified longitudinal section in
fragmentary form of the Model C of the invention focussing on the
middle important features.
FIG. 6 is an enlarged central cross-sectional view of Type 1 of the
elasto-valvular mechanism or component.
FIG. 7 is an enlarged central cross-sectional view of Type II of
the elasto-valvular mechanism or component.
FIG. 8 is an enlarged central cross-sectional view of Type III of
the elasto-valvular mechanism or component.
FIG. 9 is an enlarged end view of the elasto-valvular mechanism or
component of the Type I shown in FIG. 6.
FIG. 10 is an enlarged end view of the elasto-valvular mechanism or
component of the type II shown in FIG. 7.
FIG. 11 is an enlarged front view of the elasto-valvular mechanism
or component of the Type III shown in FIG. 8.
FIG. 12 is an enlarged pictorial illustration of the relationship
between the blood flow and control of such flow, the vein, the
presently applied for poly-sample hypodermic needle shown attached
to the plastic VACUTAINER HOLDER -- all of which are drawn in
central longitudinal views in an inter-connecting fashion. The
VACUTAINER tube is drawn in a side elevational view and unattached
to the hypodermic needle.
FIG. 13 is a much more magnified pictorial illustration of the
relationship between the blood flow and control of such flow, the
vein, the poly-sample hypodermic needle which is attached to the
VACUTAINER HOLDER shown only in its frontal fragmentary form. All
these basic components are drawn as interconnected to one another
and shown in the central longitudinal sectional view.
FIG. 14 is another enlarged pictorial illustration of the
relationship between the blood flow and the propagation of such
flow, the vein, the poly-sample hypodermic needle attached to the
VACUTAINER HOLDER. All these important components are drawn in an
inter-connected central longitudinal sectional view. Here the
VACUTAINER tube is shown properly engaged in the aspirating
position, wherein the diaphragm of the rubber stopper plugging the
said VACUTAINER tube has been pierced correctly by the hind portion
of the rear cannula. The said tube is presented as partly drawn in
the central longitudinal sectional view and partly in the side
elevational view.
FIG. 15 is another enlarged pictorial illustration of the
relationship between the blood flow and the inhibition or stopping
of such continous flow within the device without removing the
hypodermic needle's intra-venous engagement, and, without resulting
in an undesirable blood drip or spatter even though the filled-in
sample tube had already been pulled away from its connection with
the rear cannula. The elasto-valvular mechanism or component is
shown in the closed position and the poly-sample hypodermic needle
is still firmly installed with the internally threaded bore of the
tube holder.
FIG. 6 is a side elevation drawing of a typical VACUTAINER tube
that has been pre-evacuated and ready to be substituted into the
barrel of the VACUTAINER HOLDER as soon as the preceding
blood-filled collection tube has been completely cleared away from
the barreled holder.
FIG. 17 is another side elevation drawing of an unused VACUTAINER
tube, next in line and to be utilized during the process of venous
blood multi-sampling.
FIG. 18 is an enlarged end view of the elasto-valvular mechanism or
component of the Type I shown in FIG. 9, but this time, the
valvular lips are in the open position. Surrounding its outermost
circumference is a circular cross-section of the enveloping main
supporting transparent plastic material.
FIG. 19 is an enlarged end view of the elasto-valvular mechanism or
component of the Type II as shown in FIG. 10. However, the valvular
lips are now illustrated in the open position. Fitted around the
outermost circumferential border of the elasto-valvular structure
is an enveloping cross-section of the main supporting transparent
plastic material.
FIG. 20 is an enlarged frontal view of the elasto-valvular
mechanism or component of the Type III as shown in FIG. 11. Instead
of the valvular lips drawn in the normally closed fashion, they are
illustrated in the open position.
FIG. 21 is an enlarged central longitudinal sectional view of still
another kind of poly-sample hypodermic needle herein designated as
the Model D of the present invention.
FIG. 22 is a much more magnified central longitudinal sectional
view of the Model D poly-sample hypodermic needle that is in the
continously aspirating position. The hypodermic needle is also
shown as inter-connected with the VACUTAINER HOLDER, and, having
completely pierced the diaphragm of the rubber stopper plugging the
collection tube with the rear cannula's hindmost sharpened edge,
while on the forward side, part of the front cannula is shown in
the correct intra-venous position. The front cannula, the rear
cannula, the VACUTAINER HOLDER and the VACUTAINER tube are all
drawn in the longitudinal section, and, partially in fragmentary
form. The vein is illustrated in longitudinal section with the
blood sample flowing from the venous lumen through the relevant
internal structures of the hypodermic needle, and then transported
into the evacuated collection tube.
FIG. 23 reveals an enlarged end view of the elasto-valvular
mechanism or component of the Type IV which is shown in the close
position. Enveloping the outermost borders of the said component is
a cross-section of the main supporting material made of plastic
composition.
FIG. 24 illumines an enlarged end view of the elasto-valvular
mechanism or component of the Type IV as shown in FIG. 23, but this
time the valvular lips are shown in the open position. Like FIG.
23, the enveloping main supporting transparent material is seen
fitted around the elasto-valvular component.
FIG. 25 is an enlarged cross-sectional view taken from lines 30 and
30 along the direction of arrow m and m of FIG. 21.
FIG. 26 is an enlarged cross-sectional view taken from lines 32 and
32 as seen along the direction of arrows q and q of FIG. 21.
FIG. 27 is an enlarged cross-sectional view taken from lines 34 and
34 as perceived along the direction of arrows s and s of FIG.
21.
FIG. 28 is an enlarged central longitudinal section, partly in
fragmentary form, of another alternative version of the same
invention, herein assigned as the Model E, and, focussing on still
a further type of elasto-valvular mechanism or component known as
the Uni-Lip Elasto-Valve Type V. The drawing illustrates the
elasto-valvular mechanism or component in both its close and open
position.
FIG. 29 is an enlarged central longitudinal section, partly in
fragmentary form, of a sixth version of the poly-sample hypodermic
needle, herein designated as the Model F, and, centering on a sixth
possible type of elasto-valvular mechanism or component called the
Mono-Oval Elasto-Valve Type VI which is illustrated in both its
close and open positions.
DETAILED DESCRIPTIONS
In FIGS. 1, 2 and 3, the following numerals and letters refer to
specifically detailed parts of the first three models of the
Euclidean Automatic Elasto-Valvular Poly-Sample Hypodermic
Needle.
Numeral 1 is the frontal beveled end of the front cannula that is
useful for the proper penetration of the skin and the immediate
underlying tissues, as well as the wall of the blood vessel
preferably a vein, 2 is the exposed extension or shaft of the front
cannula, 3 is the bore that runs axially through the front cannula.
The rear part of 2 designated as 4 is centrally and firmly held in
the straight position by the front segment 6 of the main supporting
material, 5 is the rearmost extent of the axially running bore 3 of
the front cannula, 6 partially supports the elasto-valvular
component 8 and internally having a centrally located cavity X that
borders between 5 and 8; 7 is the junction in the main supporting
material that integrates 6 with 10 which is the rear segment of the
main supporting material that centrally holds the frontal part of
the rear cannula in an inflexibly straight longitudinal position.
Junction 7 completes the firm support for the outer circular
margins of the elasto-valvular component; both 6 and 10 compose the
main supporting material joining at 7; 9 is the foremost extension
of the axially running bore of rear cannula 13 that communicates
with cavity Y of the structure 10, and, such cavity Y frontally
bordering at the hind face of the elasto-valvular component; 11 is
the unexposed portion of the rear cannula that is held firmly by
the central rear part of 10; 12 is the externally threaded screw
form adapter which is a rear extension of 10, and which is so
constructed to be adaptable with the corresponding internally
threaded central bore of the VACUTAINER TUBE HOLDER; 14 is the rear
cannular bore; 13 is the exposed hind extension or shaft of the
rear cannula; 15 and 16 are both lateral holes of the rear cannula
that link bore 14 with the outside; 17 is the point-ending sharply
piercing hindmost extension of rear cannula 13.
The main differences between FIGS. 1, 2 and 3 as they respectively
represent the first three models of the present invention
designated as Models A, B and C, respectively, chiefly rest upon
the varying configurations as well as upon either the transparency
or the non-transparency of the main supporting material that holds
the front and the rear cannulas including the elasto-valvular
component in place, variations in the shapes of cavities X and Y
found therein as far as their respective internal configurations
are concerned, and, structural variations relevant to the
functional capabilities of the elasto-valvular components.
In FIG. 1, the main supporting material is shown as transparent,
and, preferably constructed of strong solid plastic material;
likewise, in FIG. 3, the main supporting material is also
represented as transparent, and again, preferably made of strong
solid plastic material. The advantages of this transparency of the
main supporting material are: 1) the allowance of a visual means of
checking the functional efficiency of the elasto-valvular component
situated therein, and 2) the inherent property of the enveloping
main supporting material of enabling the operator to gain a
positive visual knowledge as to whether or not the optimal blood
flow has already ensued from the vein through the bore of the front
cannula by watching for the inflow of blood into the cavity X, just
before pre-exposing the vacuum of the first collection tube prior
to proceeding in the sequence of venous blood multi-sampling.
In FIG. 2, however, the main supporting material may be constructed
of non-transparent constitution, which may be of opaque plastic,
aluminum or any other preferable metals. This does not favor the
provision of a visual indicator means helpful on the part of the
operator in affording him the accurate knowledge on the functional
status of the elasto-valvular component, nor does it allow him in
correctly determining whether or not he has properly punctured the
vein before using some of the essential negativity of pressure of
the first sample tube. This model, however, is only being
introduced as an alternative in case the manufacturer would prefer
the production of such non-transparent poly-sample hypodermic
needle for reasons of its own.
In FIG. 4, which is a more magnified longitudinal section in
fragmentary form of the middle fundamental components of the Model
A of the present invention, the following numerals, letters or
letter-numeral combinations are given to the various parts:
The numeral 2 is part of the exposed portion of the front cannula;
3 is the axially running bore of the same cannula; 5 is the
rearmost extension of the axially running bore 3; 4 is the
unexposed portion of the front cannula that is firmly held in the
straight position by 6 which is the front segment of the main
supporting material; X is the cavity formed centrally and
internally within 6; 18a is the symmetrically and smoothly
converging borders of the cavity X; 7a is the junctioning part of 6
and materially joining with the outer sector of 7b which is the
foremost junctioning portion of the rear segment 10 of the main
supporting transparent material. Separately drawn between the front
and the rear segments of the main supporting material is the
elasto-valvular mechanism or component shown in the normally
closed-lip position. This elasto-valvular component is designated
as 8, and, its different parts are represented by the following
letters:
d is the outermost part of the said component; a is the flanged
portion that fits into the socket built in 7b; e is the flat part
that rests snugly against the inner portion of 7a; f is the flat
surface at the hind face of the said component that tightly presses
against the innermost sector of 7b; b and b are the valvular lips,
and, c is the valvular slit.
Y is the rear cavity formed centrally and internally within the
structure of the rear segment 10 of the main supporting material;
18b is the symmetrically and smoothly converging borders of cavity
Y that ends rearwardly at 9 which is the foremost extension of the
axially running bore 14 of the rear cannula; 11 is the unexposed
part of the rear cannula that is held firmly and straightly by the
central rear sector of the rear segment 10 of the main supporting
material; 12 is part of the rear segment 10 which is an externally
threaded screw form adapter.
In FIG. 5 which is another more magnified longitudinal section in
fragmentary form of Model C of the same invention, the middle
features are brought into a more detailed attention, viewing how
the different parts are structurally and functionally inter-related
to one another from the standpoint of fittable pre-fabricated
components on one hand and in the light of a more practical and
economical method for mass production.
The following numerals, letters and numeral-letter combination are
given to various parts: 2 is the exposed portion or shaft of the
front cannula as seen partly in fragmentary form; 6b is the flanged
foremost sector of the front segment of the main supporting
material, while 6a is the inner unflanged portion of the same; 7a
is part of a circumferentially molded recess at the rearmost outer
sector of the front segment of the main supporting material wherein
the flanged part of the elastovalvular component, designated in the
drawing as letter a, is to be snugly fitted; d is the outermost
part of the said component that is to be tightly pressed against
the outermost borders of the circularly running recess 7b of the
rear segment 10 of the main supporting material; f is that part of
the said elastovalvular component that must rest against the
rearmost borders of 6a; b and b are both elasto-valvular lips, and,
c is the elastovalvular slit. Meticulous observation would reveal
that, in the construction of this particular Model C, the fittings
of the flanged portion of the elasto-valvular component is reversed
in so far as its being compared to the fittings of the same flanged
portion seen in Models A and B. This, as can be noticed, is just
another structural alternative designed towards achieving another
desirable economical aspect for reliable mass-manufacture, however,
the chief function of the elasto-valvular component relevant to the
valvular lips' rearward swing with the aim of attaining the open
position, is still focussed towards cavity Y which is the centrally
located internal pre-molded cavitation of 10; X is the tubular fore
cavity that runs longitudinally and symmetrically within the
borders of 18a found at the central part of the front segment 6a of
the main supporting material, and that the said cavity X is axially
aligned and in direct communication with the rearmost extent of the
front cannular bore represented as 3; 18b is the smoothly
converging internal physical limitations of the rear segment 10; 9
is the foremost extent of the rear cannular bore 14, and which is
in direct space-continuum with cavity Y; 11 is the frontal portion
of the rear cannula that is held firmly and straightly in an axial
way by the hind central part of the rear segment 10; 12 is a
portion of the externally threaded screw form adapter found at the
hindmost portion of 10. It is suggested that in this particular
model as well as in the other models of the present invention, the
best practical way of achieving more effective mass-production
calls for the pre-fabrication of the various desired applicable
configurations of each important component such as (1) the
elasto-valvular component, (2) the front segment of the main
supporting material 6a and 6b, wherein the cavity X and the recess
7a are pre-molded, (3) the front cannula mounted firmly in the
correct longitudinal position, (4) the rear segment of the main
supporting material 10 wherein the cavity Y and recess 7b and the
externally threaded screw form adapter designated as 12, are
pre-molded, (5) the rear cannula fixed in proper position. After
the accomplishment of the said pre-fabricated components, the two
segments of the main supporting material can now be fused together,
sandwiching the grippable parts of the elasto-valvular component
between the said front and rear segments. As have been previously
illustrated in FIG. 3, wherein the needle is assembled and shown in
its entire longitudinal section, the cavities X and Y are separated
by the elasto-valvular component only while it is in the close
position. The external contour defined by the combination of 6a
bordered by the rear part of 6b and the foremost extent of 10 can
be very well utilized as the finger-grippable part, such part
rendering a convenient shape during the quick installation and
subsequent disengagement of the poly-sample hypodermic needle in
relation to the internally threaded bore of the plastic VACUTAINER
HOLDER through which 12 is made adaptable.
In FIG. 6 which is an enlarged section of the elasto-valvular
component that had been centrally sliced in a straight sidewise
manner, the following letters are used to represent the different
elaborate parts of this Type I of elasto-valvular component:
Letters d, e, a and f are the outer portions of the said component
that engage with 7a and 7b of the front and rear segments of the
main supporting material which have been previously named and
described in FIG. 4. The only differences here are the presence of
part g which is merely a flat, hindly situated, broadly running
circumferential indentation from the flat surfaces of f, and the
basic function of this is merely to decrease the material thickness
of that part preparatory to the concave abrupt indentation h1 that
is of narrow width and, again, circumferentially running when seen
from the end-view, and found just before the valvular lips take
form within the confines of the hind face of the said
elasto-valvular component. The main function of h1 is to allow the
valvular lips with the easy bending characteristics in their
rearward swing during the attainment of the opening phase while the
FACUTAINER tube is in the process of aspirating the necessary blood
volume from the vein through the poly-sample hypodermic needle. The
purpose of the h1 concavity is the advantageous diminution of the
rubber material along that area which, in effect, will offer more
pliability on the part of the automatically actuatable valvular
lips, a necessity in this particularly stiffer constitution of the
elast-valvular component to make such actuateable valvular lips
much more sensitive to pressure differential gradients. The part h2
is the corresponding cancave abrust indentation opposite h1 and
located at the fore-face of the elasto-valvular component; h2,
likewise is narrow in width, and, located just before the start of
the outer formation of the valvular lips, and also running
circumferentially when seen from its front view; h2 also adds to
the desired pliability of the elasto-valvular lips due to the
effects of re-calculated material decrement along its extent
resulting in less stress that would otherwise cause greater
resistance to the rearward swing of the elasto-valvular component.
On the basis of such construction of this particular type, it is
clear, from the viewpoint of material thickness, that the valvular
lips' constitution is thickest near the inner borders of h1 and h2,
and then gradually diminishing in thickness towards the central
part wherein the valvular slit is found. In the elasto-valvular
component's construction, therefore, it is at point or line
defining the extent of c that is structurally least resistant
against the hindwardly propelled fluidic mass of blood emanating
from the vein, so that, as soon as the vacuum of the VACUTAINER
tube is correctly engaged with the rear cannula, the greater
aspirating power of the said collection tube will cause a greater
pressure differential between the blood-filled cavity X and the
cavity Y that is directly in space continuum with the bore of the
rear cannula, which is now linked with the vacuum. This condition
triggers the valvular lips to achieve relative optimal apertural
sizes in direct proportion to the pressure differential changes;
the valvular lips' opening activity at the site of the valvular
slit c brings forth the flow of blood specimen for optimal
transport from cavity X to cavity Y and then into the said
VACUTAINER tube through bore 14 of the hind cannula.
In FIG. 7, similarly, the different letter designations as given to
the elasto-valvular component illustrated in FIG. 4, are basically
the same, and that the functions of the different parts are also
the same. This illustrates another type of elastovalvular component
named as Type II. It is only slightly different from Type I shown
in FIG. 6. In this elasto-valvular component, the other parts
corresponding to Type I are similar except for the absence of parts
g, h1 and h2. Of importance to note is that the valvular lips b and
b are structurally shaped to show a more forwardly inclined contour
in relation to the perpendicular outlines of configurations e and
f. Also apparent is the characteristically larger area of
elliptical swing of b and b. This design may prove to be favoring
the use of a softer structural property of material as an essential
factor in the construction of this particular type of
elasto-valvular component.
In FIG. 8 which illustrates the Type III of the elasto-valvular
component, the letter-designated parts a, d and e correspond to the
engageable configuration that is made to be adaptable to the
pre-fabricated recesses 7a and 7b seen in FIG. 5; the part f is
made flat to snugly press against the flattened hindmost border of
the front segment of the main supporting material 6a and 6b shown
in FIG. 5. From the inner extents of part e and f of the component,
a pair of right-angled fore and hind indentations opposite each
other start the structural configurations that finally form the
valvular lips b and b; j and j are the sites where the hind face of
the valvular lips b and b begin to bulge in material thickness to
form i and i which are actually thickened edges of the
elasto-valvular lips, and which form a streamlined circularly
running bulge across which the valvular slit or slits are made. The
chief rationale governing the pre-forming of this structural
thickening i and i is the provision of more material constitution
around the edges of the valvular lips, aimed towards the attainment
of steadier and more resistive elasto-valvular edges such as in the
case wherein the rubber material selected for construction is in
the order of a softer or of a more physical yieldable consistency
characterized by: (1) lesser density rubber material with the least
stiffening additive ingredient, or (2) rubber material of optimal
structural quantities of spongy or tightly foamed nature. Note the
reversed installation of the flanged outer portion defined by the
a, d and e configuration of the elasto-valvular component which can
be adaptable to the pre-recessed parts 7a and 7b of the front and
rear segments of the main supporting material shown in FIG. 5, in
contrast to the rear-facing installation of the respectively
flanged portion of the elasto-valvular component of the Type I or
Type II seen as adaptable to the corresponding recess 7b of the
rear segment 10 of the main supporting material as illustrated in
FIG. 4. However, the rearward swing of the valvular lips b and b in
order to achieve an open position as a result of the valvular-lips'
automatically actuated response to the sucking action by the vacuum
of the pre-evacuated sample tube, remains comparatively the same as
in Types I and II of the elasto-valvular component.
In FIG. 9 which is an enlarged end view of the Type I of the
elasto-valvular component, the portion occupied by part a, which is
seen in the side sectional view in FIG. 6, is illustrated clearly
as extending around the outermost margin of the component, and,
that which runs circularly and flatly. Parts f and g, respectively
are shown occupying the next two inner portion of the same
component, both parts f and g, likewise, running circularly,
flatly; h1 which is the hindly situated circularly running narrow
groove is illustrated bordering the outermost extensions of the
valvular slits c1, c2 and c3 that form the corresponding valvular
lips b1, b2 and b3.
In FIG. 10 which is the enlarged end view of the Type II of the
elasto-valvular component, vividly shows the circularly and flatly
running contours defined by parts a and f, and that b continues,
materially, towards the center and actually forming the four
symmetrically arranged valvular lips b1, b3, b3, and b4 after the
valvular slits c1 and c2 criss-cross straightly across the center,
each slit dimension being equal and starting the physical break
equi-distantly from the inner border of f, and just a few measure
centrally within the confines of b.
In FIG. 11 which is the enlarged front view of the Type III of the
elasto-valvular component, the flatly and circularly running areas
of parts a and f can be seen; within the scope of b can be observed
the equally dimensioned valvular slits c1, c2, and c3 which
confluence and cross the center up to their correspondingly
opposite limits in relation to their respective starting points.
The resultant of this slitting method is the actual formation of
the equi-angular shapes of the respective valvular lips b1, b2, b3,
b4, b5 and b6.
Specially important to note is that, in FIGS. 6, 7, 8, 9, 10 and
11, the elasto-valvular lips that correspond to each of the three
different types of elasto-valvular components, are all in the
normally closed position.
FIG. 12 which is the enlarged pictorial representation of the
relationship between the vein, the blood, the polysample hypodermic
needle and the VACUTAINER HOLDER as drawn inter-connectedly in the
central longitudinal section, vividly illustrates the following
labeled parts:
The numeral 1 is the forward beveled sector of the front cannula 2,
and, which is presently shown having made the optimal penetration
of the venous wall 19 at point 21, and that, part of the blood 20
flowing through the vessel's lumen is transported through the bore
of the front cannula and filling the cavity X formed within the
confines of 6; 8 is the elasto-valvular component; the cavity Y
which is formed within the confines of 10 is shown still unoccupied
by blood; 12 is the externally threaded screw form adapter of the
poly-sample hypodermic needle that has been firmly positioned by 22
which is the foremost central structural enlargement of the
VACUTAINER HOLDER, such structural enlargement having a central
internally threaded bore, pre-formed to fit 12; lateral holes 15
and 16 of the rear cannula are shown located near the point-ending
piercer 17 of the rear cannula; 24 is the section of the tubular
body of the plastic VACUTAINER HOLDER, and 23 is the barrel within
its internal confines; 25 is the flanged portion of the plastic
VACUTAINER HOLDER that is finger-grippable and utilized by the
operator during the blooddrawing procedure.
The blood flow from the vein into the said cavity X has been
brought about because of the existing pressure differential between
the venous side and the lesser pressure inside cavity X. Whatever
volume of air previously occupying the said cavity is of
considerably negligible quantity, for in the actual scale of cavity
X, the space is only of a small dimension, enough to accommodate
just a minute amount of blood ensuing into it from the venous side
through the bore of the front cannula; such small blood quantity
perceivable by the operator due to the transparency of the
enveloping plastic material of the front segment of the main
supporting material, thus indicating positively whether or not the
proper venous penetration has been made before exposing the vacuum
of the initial pre-evacuated sample tube. This small quantity of
air normally trapped inside such cavity X of a pre-used poly-sample
hypodermic needle would, in no way, endanger the patient with a
substantial air emboli, for such gaseous mixture would be prevented
from entering the vein due to the pre-existing pressure
differential between the greater venous pressure and the lesser
pressure characteristic of cavity X when the front cannula has made
the proper venous penetration. Instead, blood is transported from
the venous side through the front cannula bore and into the said
cavity X, displacing the previously occupying small amount of air,
such blood inflow forcing such thin gaseous mixture through the
very narrow but adjustable valvular slits of the elasto-valvular
component capable of making the essentially selective gaseous
escape from cavity X into cavity Y. As the air from cavity X enters
cavity Y, a correspondingly equal volume of air escapes through the
rear cannular bore, exiting from the lateral holes 15 and 16 to the
ambient environment. The blood being of much denser and viscous
property cannot escape the very narrow valvular slit or slits, in
contrast with the positive escaping ability of the much lesser
density air. In this situation, the valve cannot be actuated to
widen considerably in aperture size so as to permit the
characteristic viscous-quality transport of blood due to the
biophysically based reason that the pressure differential between
the venous side and the ambient condition is inhibited by the
pre-calculated structural stiffness of the selected construction of
the elasto-valvular mechanism. Hence, no blood would be coming out
from the rear cannula, even though the correct puncture of the vein
has already been made, for the initial VACUTAINER tube is still
unlinked with the needle. At this phase of the operation, the
elasto-valvular mechanism cannot achieve the open position in
conjunction with the actual process of venous blood extraction,
since the negativity of pressure of the vacuum of the said sample
tube has not yet been connected with the bore of the rear cannula
that would have caused the valve to open allowing blood transport
from cavity X into cavity Y then through the rear cannular
bore.
Included in FIG. 12 is the said first or initial VACUTAINER tube
that is still unconnected to the hind portion of the rear cannula;
such container tube is viewed in the side elevation and shown
partly inserted into the barrel of the holder 24. Numeral 26 is the
flanged rubber stopper of the VACUTAINER tube 27, and that, the
rubber stopper has not yet been pierced by 17, thereby, the vacuum
contained inside the said container tube is still unexposed. The
said tube in this case, as can be seen, is yet devoid of any blood
contents.
FIG. 13 is a much more magnified pictorial illustration of the
relationship referred to in FIG. 2, except that the VACUTAINER tube
is ommitted in the drawing. The blood 20 is shown flowing from the
vein 19, and partially transmitted through the bore 3 of the front
cannula 2, having passed through the front cannula's rear exit 5 to
fill cavity X. As can be cearly understood, the blood has been
transported from the venous lumen because the foremost open beveled
end of the front cannula has made an optimal penetration of venous
wall 19 at site 21, and that, the said beveled portion is properly
positioned inside the vein. Therefore, as previously mentioned, the
blood is made to pass through the said bore 3 into X because of the
existing substantial pressure differential between the venous side
and the cavity X, however, due to the pre-calculated stiffness of
the elasto-valvular component enabling it to resist the range of
possible venous pressure fluctuations from individual to
individual, there can be no blood volume transfer from cavity X to
cavity Y until the pressure differential becomes greater as can be
achieved when the VACUTAINER tube has already been installed at the
opposite side. Notice that, by looking at the unwidened view of the
valvular slit c, and, noticing the unswung valvular lips b and b,
the elasto-valvular mechanism is still substantially in the
normally close position. The numeral 7 represents the junction line
between the front and the rear segments 6 and 10 of the main
supporting material. At this particular phase of operation, since
the first container tube has not yet been installed, cavity Y is
yet devoid of blood contents. And, due to the transparency of the
main supporting material's front segment, the blood inside cavity X
can be seen by the operator, thereby indicating to him when the
vein had already been properly punctured and the initial blood flow
from the vein through bore 3 had already ensued. The operator can,
at this time decide to link the vacuum of the said container tube
into the system without any trial-and-error method. By following
this procedure, utilizing the advantageous feature of the
transparency of the said device, the vacuum capacity of the
pre-evacuated sample tube cannot be prematurely exposed. The
numeral 9 is the rear cannular entrance that communicates cavity Y
through bore 14 to the ambient environment when the poly-sample
hypodermic needle is not linked with the tube or, to the vacuum of
the container tube when the said poly-sample hypodermic needle is
connected with the said pre-evacuated vial. The parts and functions
represented by the numerals 12, 22, 15, 16, 17 and 24 have already
been previously mentioned in FIG. 12.
In FIG. 14 which is another enlarged pictorial illustration showing
the relationship between the interconnected important components
included in the VACUTAINER METHOD of blood specimen extraction
vividly illustrates the propagation of blood flow through the now
open elasto-valvular component, after the VACUTAINER tube has been
installed with the system. The causative factor for the opening of
the valvular component 8, causing blood transport across its opened
valve, from cavity X into cavity Y, and, propgated through the bore
of the rear cannula into the aspirating sample tube, after exiting
through the lateral holes 15 and 16, is the creation of the
automatically actuating greater pressure differential that now
exists between the positive pressure inherent in the venous side,
and the negative pressure characteristic of the vacuum contained
within the evacuated collecting vial on the other side. This abrupt
increment of the said pressure differential as a result on the
installation of the said tube, triggering the valvular lips to
swing rearwards, permitted the widening of the valvular slits, thus
allowing blood to flow through the entire device. The arrows r1 and
r2 indicate the direction of the blood quantities being aspirated
from lateral holes 15 and 16, respectively, during the collection
of specimen into the said VACUTAINER tube. Part 26a is the flanged
portion of the rubber stopper plugging the container tube, and, 26b
is the diaphragm of the same rubber stopper that has now been
pierced by the point-ending piercer of the rear cannula. All the
other parts represented by the other numerals in this figure have
been previously named and described in FIG. 12.
FIG. 15 which is another enlarged pictorial representation, drawn
partly in central longitudinal section, includes the relationship
between the aforementioned important components, but, this time,
the VACUTAINER tube filled with collected blood specimen, is shown
to have been disengaged or pulled away from its physical connection
with the poly-sample hypodermic needle. It is of utmost importance
to note that, due to the inherent elasticity of the elasto-valvular
mechanism 8, the corresponding valvular lips had sprung back to
their original close position as an after-effect of the tube's
having been pulled away from its cannular linkage. The pressure
differential that now exists between the venous side and the
ambient environment on the other side is precalculatedly too weak
to maintain the valve's open position; the elasto-valvular
component having been specially constructed and pre-tested to
attain the specifically desired safe range of resistive elasticity
prevents the propagation of the continuous blood flow through the
valve when no VACUTAINER tube is interconnected with the system. In
this figure, the front cannula is still in direct communication
with the vein, and through blood is now present in both cavities X
and Y as well as inside the front and rear cannular bores, blood
drip or spatter into the ambient environment is prevented from
occurring, for the reason that no further blood flow is permitted
by the close valve to cross through it at this time. All the
numerals and letters that represent the specific parts and
functions were already described in FIGS. 12, 13 and 14, with the
exception of numeral 20 which represents the blood that had been
collected and shown as contained inside the VACUTAINER tube.
After the first blood-filled collection tube had been removed from
the plastic VACUTAINER HOLDER, the next pre-evacuated sample tube
shown in FIG. 16 can now be installed into the barrel of the said
holder, and then, connected again with the same system by forwardly
pushing the tube 27 at its base with the thumb or palm of the hand,
so that the rubber stopper can be properly pierced at its
diagphragmatic area by the pointed sector of the rear cannula.
Since there is no external rubber sleeve at this rear cannula as in
the case of the B-D MULTIPLE-SAMPLE HYPODERMIC NEEDLE, the piercing
of the rubber stopper by the rear cannula of this presently applied
for invention can be performed more easily on account of the
advantageous property of the device in affording greater ease in
the operator's performance while offering a much less
pre-disposition to traumatic injuries on the part of the patient.
As soon as the second VACUTAINER tube has been installed, the blood
flow would again ensue, for the valve will regain its automatic
opening phase as a result of the triggering effect of the sudden
pressure differential increment between the venous side and the
aspirating vacuum of the collection tub, thereby causing blood to
be collected into the second sample tube.
During the filling phase, the valve's aperture is not constant
because the valvular opening and closing responses are relative to
the pressure differential gradients between the venous side and the
degree of negativity of pressure of the collection tube. Hence, at
the start of the aspiration phase effected by the vacuum, the
valvular lips are readily swung rearwards from their close
position, towards the direction of the aspirating medium, widening
to the largest attainable aperture size depending upon the
intensity of the vacuum, which, of course, would also depend upon
the diameter and length of the VACUTAINER tube used. As the fluidic
mass of whole blood is being collected, the vacuum capacity
correspondingly decreases, and, the valvular lips automatically
respond by relatively narrowing the aperture sizes up to a point
when it is about closed, at which time, most of the vacuum has
already been consumed due of the positive occupancy of the
collected blood specimen therein. From the standpoint of
Biophysics, this adjustability of the valvular aperture sizes
effected by the responsive automatic adaptibility of the said valve
to the variations in the pressure differential gradients, in
addiiton to the structural streamlining of the valvular lips
themselves, jointly help reduce the danger of disintegration of the
cells suspended in the plasma. This is one of the chief advantages
of this polysample hypodermic needle over those in current use that
are inefficient in adjusting to such pressure differential
gradients secondary to the constant aperture size through which the
blood sample is forced to pass. The high shear forces affecting the
onrushing whole blood being collected through the currently
produced hypodermic needles, for example, those produced by B-D and
MPL, are not substantially reduced hence resulting in a greater
chance of hemolysis and other cellular disintegration.
After the second collection tube had been filled with specimen, the
cycle of operation is repeated as aformentioned, soon as the third
sample tube has been installed.
In case the operator desires to disengage the collection tube away
from its linkage with the poly-sample hypodermic needle, before the
said pre-evacuated sample tube has completely been filled with
specimen, the basic design of the inter-paced lateral holes 15 and
16 may prove as an essential deactuating means which can optimally
cause the easy snapping of the valvular lips towards the close
position. This advantage is brought about because the two
inter-paced lateral holes become sequentially blocked by the solid
mass of rubber that constitutes the pierced disphragm of such
rubber stopper during the slow pulling of the sample tube away from
its connection with the rear cannula. Note that the inter-pacing of
the lateral holes does not have to be exactly in the same
proportion as illustrated; such inter-pacing of the lateral holes
can be made farther apart as far as the longitudinal relationship
to one another is concerned provided that better efficiency of the
device is achieved. The easy, yet quick enough closure of the said
valve as the operator gently pulls away such sample tube will
prevent the occurrence of blood drip during the span of time
between inter-tubular changing in the course of multi-sampling from
the vein.
In FIG. 18 which is the enlarged end view of the elasto-valvular
component of the Type I, it is fully illustrated how the valvular
lips attain their completely open position at the height of the
vacuum's aspirating power. This fully open position of the valve is
achieved at the time when the pressure differential between the
venous side and the said vacuum is at the greatest value. As can be
seen, the valvular lips appear to have reacted in such an orderly
manner due to the presence of the pre-set equal length and
equi-angularly arranged valvular slits c1, c2 and c3, which are
originally illustrated in the closed position in FIG. 9. This
allows the corresponding valvular lips the freedom of displacement
reactivity that can variably achieve the adjustable aperture sizes
relative to the aforementioned pressure differential gradients.
The parts a, f and h1 correspond to the parts already named in FIG.
9, and can be seen almost identically except for the following (1)
The valvular lips are swung rearwards thus attaining the open
position (2) h1 is seen to be more narrowed secondary to the
compressing action of the rearward swing of the valvular lips b1,
b2 and b3 (3) The presence of 10 which is a cross-section of the
transparent plastic solid material that supports and envelopes the
elasto-valvular component (4) The presence of t1, t2, t3 and t4
seen as equi-distantly placed inverted V-shaped protrusions at the
outer edge of 10; the purpose of such protrusions being to provide
an adequate structural means to increase traction or
finger-grippability so necessary for the effective installation and
subsequent disengagement of the adaptable end of the poly-sample
hypodermic needle to the respective internally threaded bore of the
VACUTAINER HOLDER.
In FIG. 19 is the enlarged end-view of the Type II of the
elasto-valvular component as it appears being enveloped around its
outermost circumference by the cross-section of the transparent
solid plastic material 10. The valve is shown in the fully open
position after it has abeen automatically actuated to open by the
pressure differential between the venous side and the vacuum's
negativity of pressure. The valvular lips b1, b2, b3 and b4 had
been swung rearwards by the aspirating action of the said vacuum.
It is through this open valve that the blood is made to pass from
the venous side into the VACUTAINER side. The parts a and f of the
elasto-valvular component are shown to be running circularly and
flatly as in FIG. 10. The valvular slits c1 and c2 are well
widened, and only the outermost borders of the said slits can be
seen in the drawing. The exterior of the enveloping plastic
material 10 that firmly holds the elasto-valvular component in
proper place can be observed to have fingergrippable arc-like
edges, again, for the purpose mentioned similarly in the
discussions involved in FIG. 18. The said traction edges are
represented by the letter t.
FIG. 20 is an enlarged frontal view of the elasto-valvular
component of the Type III as shown in FIG. 11, but this time, the
valve is in the open position; the valvular lips having been swung
rearwards cannot be fully sen. Only the outlines of internal bases
of the valvular lips b1, b2, b3, b4, b5 and b6 are seen as they are
viewed frontally; inter-paced between the bases of the six valvular
lips are the outermost borders of the widened valvular slits c1, c2
and c3; parts a and f are seen running circularly and flatly which
are similarly shown in the same fashion in FIG. 11.
From this viewpoint, it can be visualized how the blood is smoothly
transported from the venous side through the streamlined aperture
into the aspirating side of the system, after intercommunication
between cavities X and Y has been established soon after the valve
opens.
In FIG. 21 which is the enlarged central longitudinal section of
Model D of the present invention the numerals 1, 2, 3, 4 and 5 that
represent the different parts of the front cannula, are of the same
names and functions as those similar numerals in the previously
discussed models of this currently applied for poly-sample
hypodermic needle. The same is true with the parts represented by
the numerals 11, 9, 13, and 14 which are different parts of the
rear cannula, with the exception of numeral 29 which represents the
hindmost beveled sector of the rear cannula, the part that does not
appear the same compared to that rear cannular part in Models A, B
and C because, here, 29 is of a beveled-end configuration with an
axially situated exit or cannular hole through which blood can pass
into the aspirating pre-evacuated sample tube. Pertaining to 6 and
10 which represent the front and the rear segments of the main
supporting material, respectively, the essential difference is a
matter of configuration -- internally, as far as the shapes of
cavities X and Y, and, externally, as far as the countours of the
exterior.
Again, the elasto-valvular mechanism or component is situated
between the front and the rear segments of the main supporting
materials as indicated by the central cross-section of the said
mechanism shown to be sandwiched between 6 and 10. The borders of
the said elasto-valvular component are firmly placed in position
permitting the normally close elasto-valvular lips b1 and b2, to
separate cavity X from cavity Y and also allowing the optimal
freedom of such elasto-valvular lips in responding to the relevant
pressure differential sensitivity range.
The numeral 40 is a streamlined internal contour of the rear
segment of the main supporting material, and, as is evident, the
purpose is to allow a pre-calculated space for the accommodation of
the allowable limits of the rearward swing of the elasto-valvular
lips during the opening phase of the valve.
Numeral 7 is the junction between the front and the rear segments
of the main supporting material, and, at this site, the
perpendicular lines 30 and 30 are drawn straightly; the rearwardly
pointing arrows m and m, and the forwardly pointing arrows p and p
are indicated in relation to whatever particular view is taken with
respect to lines 30 and 30 of FIG. 21.
Perpendicular lines 32 and 32 are drawn and seen touching the front
segment 6 of the main supporting material, and, arrows q and q are
illustrated as rearward-pointing.
Perpendicular lines 34 and 34 are shown touching the rear segment
10 of the main supporting material, and, the forwardly pointing
arrows s and s are illustrated relating to the forward view with
respect to lines 34 and 34.
Each pair of perpendicular lines such as 30 and 30, 32 and 32, 34
and 34, as well as each pair of arrows m and m, p and p, q and q, s
and s, are correspondingly illustrated in the respective drawings
called for in the differing point of views such as in FIGS. 23, 24,
25, 26, and 27.
The numeral 12 is the externally threaded screw form adapter which
appears similar to that same part in all the previously illustrated
models.
FIG. 22 is a more magnified central longitudinal sectional view,
partly in fragmentary form of the model D of the present invention
in so far as its relationship with the other pertinent items or
factors of the VACUTAINER SYSTEM are concerned as applied during
the actual process of blood drawing. The numeral 20 represents a
blood quantity shown flowing and originating from the vein, and,
hereby illustrated to have been transported through the cannular
bore 3 of the front cannula 2, after the forward beveled end 1 has
correctly punctured one side of the venous wall 19 at site 21; and
that blood 20 having already entered cavity X after exiting from 5,
and, having passed through the open valve of the elasto-valvular
component 8, and then propagated in its flow through cavity Y as
well as through cannular bore 14 and into the interior of the
installed fragmentarily drawn VACUTAINER tube, after having exited
axially from the end of the rear cannula 13 in the direction of
arrow r.
According to the same principle of operations involved in the
features of the present invention, the elasto-valvular mechanism
responds to the pressure differential gradients existing betwen the
venous side and the VACUTAINER side, by means of opening its
valvular lips to allow the passage of blood through the device.
This is due to the pre-calculated functional reactivity of the
actuatable structural designs as well as density, elasticity,
resistance, configuration streamlining and thickness of the
elasto-valvular mechanism.
Also shown in the drawing, 6a is an external enlargement of the
front segment 6 of the main supporting material, and, that 6a had
been constructed for the purpose of allowing the necessary material
support so as to enable the lengthwise extent of the
elasto-valvular component of this Type IV to be properly and
symmetrically enclosed, and, firmly sandwiched in place between the
front and the rear segments of the main supporting material.
Also included in the drawing is the frontal part of the VACUTAINER
HOLDER 24, made of rigid plastic, and, having accommodated the
fragmentarily illustrated sample tube 27, within the tubular
confines of the holder's bore 23. The rubber stopper plugging the
sample tube's entrant end has been completely pierced by the rear
cannula 13 at the site of the rubber stopper's diagphragm 26b shown
to be centrally thinner in structural dimension.
The flanged part 26a of the rubber stopper is shown to be thicker
in sectional construction.
The entire poly-sample hypodermic needle is firmly interconnected
with the plastic VACUTAINER HOLDER and this has been echieved by
the correct fitting afforded by 22 which is the central external
enlargement of the holder; 22 having an internally threaded bore
through which the externally threaded screw form adapter 12 of the
poly-sample hypodermic needle suitably and firmly fits.
In FIG. 23 which is the enlarged cross-sectional view of the
poly-sample hypodermic needle taken from lines 30 and 30 and seen
in the direction of arrows p and p, the entire hind-face view of
the elasto-valvular mechanism or component represented by numeral 8
of the Type IV known as the Dual-Lip Polygonal Elasto-Valve, is
properly illustrated, and the outer lengthwise margins of the said
component are shown to be flatly secured against the
correspondingly flat depression that conforms with the polygonal
shape and dimension of the said component; such depression being
located centrally and at the rearmost end of 6a as well as that of
part 6. The hind-face of the said elasto-valvular component is
basically flattened except at the edges of c wherein the structure
had been contoured inwardly and slightly of convex nature. The
valvular slit c is only a singular straight slit or incision across
the middle part of the said component, and that which runs at right
angles relative to the perpendicular symmetrically arranged equally
dimensioned incisions j1 and j2 that are situated correspondingly
to each lateral region of the said component. The elasto-valvular
component 8, having an H-shaped inter-connected incision-complex as
defined by the combination of valvular slit c and the laterally
located incisions j1 and j2, is illustrated in the normally closed
position. The left and the right lateral margins k1 and k2 are
material continuities of the said component for definite
manufacturing advantage, namely, to be able to form the said
component into a singular piece without altering the proposed basic
functional feature of the H-shaped incision-complex. The circular
dotted lines, bisected by valvular slits C, and, labeled as X is
actually the unscaled representation of the circular borders of
cavity X of the front segment of the main supporting material; said
circular borders that axially ends at the fore-face of the
elasto-valvular component cannot be seen when the valve is in the
closed position as indicated by the appearance of the unswung
valvular lips b1 and b2. Shown to be enveloping the entire
polygonal borders of the elasto-valvular component is the
transparent cross-section of the oval-shaped enlargement 6a; the
ovality of the said enlargement can be very well utilized in
providing an excellent finger-grippability necessary for the fast
installation and easy disengagement of the poly-sample hypodermic
needle to and from the respective inter-linking part of the plastic
VACUTAINER HOLDER.
In FIG. 24 which is an enlarged cross-section of the same
poly-sample hypodermic needle, also taken from lines 30 and 30 and
along the direction of arrows p and p of FIG. 21, the same
hind-face view of the Type IV Dual-Lip Polygonal Elasto-Valve seen
in FIG. 23, is vividly shown, but, this time, the valve itself is
illustrated in the open position. It can be observed by the
clarified definitions of the shadings in this particular drawing
that the valvular lips b1 and b2 have been flipped rearwardly so
that the valvular slit c which has been clearly visualized in FIG.
23, but, having now completely widened, cannot be seen as a slit,
but instead, as a wide space that centrally exposes the most part
of the end-view of cavity X. During this phase, blood is
transported from cavity X into cavity Y because of the opening of
the dual-lip elasto-valve. The rearward swing of the
elasto-valvular lips b1 and b2 has physically been made possible
due to the incisions j1 and j2 that run along the sides of the
valve; and that 1 and 2 are just shadings of the linearly
illustrated bending of the hind face of the flat rubber material as
a result of the rearward swing of the valvular lips b1 and b2,
respectively. There is no change in appearance in the cross-section
of 6a as far as its enveloping and supporting the entire flatly
positioned elasto-valvular component as compared to FIG. 23,
however, since the valve is now in the open position, the central
part of 6a is seen surrounding the circular borders of cavity X.
There is no alteration in appearance of k1 and k2 since these
margins are the physical continuities of the rubber material that
remain unaffected by the opening and closing of the valvular lips,
and, this is due to the presence of incisions j1 and j2 that
disengage the said margins k1 and k2, respectively, from the
motional reactivity of the valvular lips b1 and b2.
In FIG. 25 which is the enlarged cross-sectional view of the
poly-sample hypodermic needle, taken from lines 30 and 30, but,
this time along the direction of arrows m and m as seen in FIG. 21,
the elasto-valvular mechanism cannot be visualized. The
cross-section of cavity Y is shown to be centrally located, and
around it is 40 which is a marginal circularly running-convexly
contouring structure that opens innerly into Y and wedges outerly
with the flat foremost central circular borders of 6a of the rear
segment 10 of the main supporting material. The use of 40 permits a
pre-calculated space allowing the optimal rearward swing of the
valvular lips, and therefore, since the elasto-valvular component's
fore-face is actually the one that completely covers the rearmost
extent of cavity X, the elasto-valvular component's hind-face does
not necessarily have to cover the entire extent of 40 to prevent
the blood from leaking into cavity Y from cavity X when the valve
is in the closed position.
In FIG. 26 which is the enlarged cross-sectional view taken from
lines 32 and 32 along the direction of arrows q and q as seen in
FIG. 21, the circular borders of front segment 6 of the main
supporting material are seen externally and internally. Inside the
cross-section of the said transparent structure 6, the central area
occupied by cavity X is clearly shown.
In FIG. 27 which is the enlarged cross-sectional view takne from
line 34 and 34 along the direction of arrows s and s as seen in
FIG. 21, the circular borders of the transparent-structured rear
segment 10 of the main supporting material are seen exteriorly and
interiorly. Inside this structure, the central area defining cavity
Y is vividly illustrated.
In FIG. 28 which is an enlarged central longitudinal view in
sectional and in partly fragmentary form of yet another alternative
version assigned here as the Model E or called the "Euclidean
Automatic Uni-Lipped Elasto-Valvular Poly-Sample Hypodermic
Needle," the automatically-actuateable valve named as the Uni-Lip
Elasto-Valve Type V is illustrated both in the close and open
positions. The close position of the valve is represented by the
contour of the broken lines defining 8cp allotted for the occupancy
of the said valve as soon as such valve springs back to its
normally close position from its completely open position indicated
in the embodiment of 8 op. The principle of operations is basically
similar to all the other previously mentioned models of this same
invention, in that, the valve would attain the open position in
gradations of rearward swing depending upon the pressure
differential between the venous side and the aspirating vacuum at
the VACUTAINER side. As the negativity of pressure of the
pre-evacuated sample tube is consumed as a result of the increasing
quantity of blood specimen collected therein, the valve gradually
closes secondary to its inherent structural elasticity. When the
said tube is removed from its connection with the said device, the
blood from cavity X is prevented from being transported into cavity
Y due to the optimal pre-calculated stiffness of the structural
makeup of the said valve, considerably resisting a rearward swing
because the pressure differential between the highest venous
pressure and the existing ambient pressure would prove to be still
weak enough to actuate any substantial degree of valvular rearward
swing. This is how blood is inhibited from dripping during the
process of multiple-sampling, while the hypodermic needle is still
connected intravenously. The main difference of this valve as
compared to the other valve-types mentioned before is that there is
no slit found here, this valve capable of reacting to the pressure
changes as a singular-lip structure. Again, preferably, there are
two segments of the main supporting material--the front segment 6
and the rear segment 10. Both segments are joined together at site
7, and, sandwiched between the said two segments is the upper
portion of the elastovalvular component that is held firmly in
place, while the lower portion of such elasto-valvular mechanism is
free to move rearwardly and back to its original close position. In
the close position, the botton portion of the component optimally
rests upon a groove formed at the medial part of the joint
structure of the two segments of the main supporting material. This
internally located groove furnishes a suitable configuration to
permit the corresponding contour of the said bottom portion of the
said elasto-valvular component so as to be able to physically
separate cavities X and Y from each other when such valve is in the
completely close position. There is also provided a two-unit
stationary or immovable cannulas--the front cannula and the rear
cannula designated by the numerals 2 and 13, respectively, fixed in
firm longitudinally aligned fashion by the corresponding structural
parts of the front and the rear segments of the main supporting
material. The front cannula has a foremost beveled edge 1 which is
utilizable for the puncturing of the blood vessel wall and other
tissues superficially situated in relation to the said blood
vessel's wall; such cannula being provided with a longitudinally
running bore 3 exiting at 5 into the cavity X. The rear cannula has
a point-ending piercer 17 which is utilizable for the easy
puncturing of the diaphragm of the rubber stopper of the VACUTAINER
tube. A leteral hole 15 is provided and which communicates cavity Y
with the vacuum of the VACUTAINER tube through 9 passing via the
rear cannula bore 14. The externally threaded screw form adapter 12
is attachable with the corresponding part of the plastic VACUTAINER
HOLDER.
FIG. 29 which is an enlarged longitudinal sectional view, partly in
fragmentary form, of the sixth version of the polysample hypodermic
needle called the Model F, focusses on the sixth possible type of
elasto-valvular mechanism named as the "Mono-Oval Elasto-Valve Type
VI." The main difference of this model compared to the others
mentioned before is the use of a ball-like nono-oval 8 op, which is
illustrated as it can be visualized in the open position whereby
the valve has been caused to be dislodged from its originally
closed plugging position represented by the area 8cp bordered by
the broken line curvature. The valve is centrally found and
supported by a pair of elastic connectors 8es on each lateral part,
and that such connectors linking the ball-like valve with the
correspondingly firm gripping portions within the internal
structure of the main supporting material. The structural makeup of
the mono-oval valve should preferably be of light-weight less dense
rubber material having pre-calculated or pre-tested capability of
optimally responding to the required sensitivity values of pressure
differentials governing the chief principles of operations of this
invention. The elastic connectors 8es are also pre-tested in their
elasticity range so as to be capable of allowing the dislodgment
and engagement of the ball-like valve relative to the changes of
pressures. In the closed position, the blood cannot enter from
cavity X to cavity Y, but, in the open position the blood can be
transported from the venous side into the properly attached
pre-evacuated sample tube. All the other numerals represent the
same parts as in FIG. 28 except the addition of another lateral
hole 16 situated just opposite lateral hole 15; both lateral holes
are aimed for the establishment of communication between the cavity
Y and the aspirating vacuum of the said sample tube. Notice the
longer length of both the lateral holes 15 and 16 for the purpose
of creating an instantly greater sucking action when the rear
cannula has established communication with the vacuum of the
collection tube; such greater equi-aspirating action of the
dimensionally equal and non-inter-paced oppositely placed lateral
holes would cause a balanced dynamically favorable displacement of
the ball-like valve without considerable linear deviation of the
said valve in relation to the centrally situated rearmost extent of
cavity X, and, at the same, preventing any possible vibrational
flutter of the dislodged ball-like valve that could interrupt the
optimally smooth flow of specimen across the valve during the whole
blodd's passage along such open medium.
In the embodiments illustrated in the drawings, it is to be
understood that such drawings are for the purpose of merely
visually describing the six preferable models including the
different elasto-valvular types for the design of this new
polysample hypodermic needle, hence, the said drawings have not
been drawn in the exact scale and proportion as far as each part
inter-relates with the other parts. As can be observed, the
configurations, both exteriorly and interiorly, vary depending upon
the selected model as well as the chosen elasto-valvular type, it
is also possible that certain other adjustments in measurements and
other forms of structural modifications can also be made aimed to
suit the optimal level of functional capabilities that well
characterize the best advantages for the device as determinable in
the course of experimental pre-testing of the various parts
comprising such device. The inventor, therefore, does not limit the
scope of his applied for invention to the exact structures
described and shown here as long as the novel features embracing
the applicable principles of his invention in this particular field
of blood-sampling from the vein using pre-evacuated sample tubes
are preserved. In more specific terms, some modifications may be
made on the following:
a. the shapes and sizes of the cavities X and Y;
b. the bore length as well as diameter of the front and the rear
cannulas;
c. the dimensions and structural strengths of the main supporting
material, including the mode and site of junction between the front
and the rear segments comprising the main supporting material;
d. the transparency and opacity of the main supporting
material;
e. the shades or intensity of coloration of the main supporting
material;
f. the non-protrusion or degree of protrusion of the inner ends of
either or both the front and the rear cannulas with respect to the
cavities X and Y;
g. the nearness or the farness in distance between the inner ends
of both the front and the rear annulas in relation to the
elasto-valvular mechanism;
h. the configuration of the finger-grippable external structure of
the main supporting material for the effective installation and
disengagement of the device with the plastic VACUTAINER HOLDER;
i. the laterality or axiality of the rear cannular holes;
j. the number of lateral holes of the rear cannula and the
inter-pacing or non-inter-pacing of the plurality of lateral holes,
including variations in dimensions;
k. the use of either the beveled or point-ending piercer as the
hindmost puncturing means of the rear cannula for the purpose of
penetrating the diaphragmatic area of the rubber stopper of the
pre-evacuated sample tube;
l. the method for mass production and pre-sterlization;
m. the method of packaging to ensure the maintenace of sterility
and easier means for disposal of the used ones to avoid
contamination;
n. the type or kind of elasto-valvular mechanism or component
preferred which may be modified in accordance to the best possible
conbination of features such as (1) cross-sectional configuration,
(2) thickness, (3) structural elasticity, (4) structural stiffness,
(5) number of valvular lips, (6) kind and number of valvular slits,
(7) type of streamlining, (8) chemical composition, and (9) other
design features relevant to the effectiveness of the said
elasto-valvular component;
o. the use of other adaptable locking means other than the
utilization of the external screw threaded from adapter making the
said invneion properly inter-linkable with the corresponding kind
of VACUTAINER HOLDER, for example, one which would require a LUER
LOCK method for attachment;
With the mentioned essential considerations for the perfection of
the device within the arena of the governing features embracing the
novelty of the invention, it may be possible to manufacture not
only one, but several excellent versions based, but not limited to
the aforementioned models, on an economical mass-production scale,
thereby providing a medically efficient device that can curtail the
prevalent problems currently encountered during
mulitple-blood-sampling from the vein with just a single
venipuncture utilizing pre-evacuated sample tubes.
Although the present invention is aimed primarily for use with the
VACUTAINER SYSTEM, its excellence in performance on account of the
effectiveness of the elasto-valvular mechanism can be extended
along the field of blood-sampling using the standard syringe, but
it is necessary to remove the external rearward protrusion of the
rear cannula, or else, completely eliminate the rear cannula
itself, as long as the central bore of the rear segment of the main
supporting material is provided. However, this new version should
be specifically manufactured for this sole purpose, and to be made
effectively inter-linkable with the coupling portion of the regular
syringe. Likewise, the aim of such a modification is focussed upon
the reduction in the degree or extent of hemolysis and other
cellular destruction due to high shear forces especially
encountered during the forcibly strong pulling of the plunger of
the syringe in the course of blood withrawal using any of the
standard syringes.
MODE OF OPERATION
1. Apply the tourniquet with moderate pressure just above the
tentative site for venipuncture.
2. Locate for the best possible vein by looking for the larger or
more visually prominent vein and employing the proper palpation
technique to determine the steadier and more blood-letting
vessel.
3. Apply cotton wet with 70 percent alcohol or with other suitable
antiseptic agent at and around the chosen site for
venipuncture.
4. Remove the seelcted gauge of pre-sterilized poly-sample
hypodermic needle from its corresponding package.
5. Attach this hypodermic needle firmly with the VACUTAINER
HOLDER.
6. Insert the first of a series of VACUTAINER tube into the barrel
of the VACUTAINER HOLDER, allowing the rubber stopper part of the
said container tube to rest with its own weight upon the beveled
end or point-ending piercer of the rear cannula, while the
succeeding VACUTAINER tubes are orderly arranged in sequential
order according to specimen importance, and ready to be substituted
one after another during the course of multi-sampling from the
vein.
7. Align the front cannula along the longitudinal direction of the
target vein, and at the same time tilting the inter-connected
system comprising of the tube holder, the VACUTAINER tube and the
poly-sample hypodermic needle to about 15.degree. angle in relation
to the plane defined by the surface of the skin. Also see to it
that the forward beveled part of the hypodermic needle is either
facing up or facing down depending upon the preferred
technique.
8. With the index finger of either hand, preferably of the right
hand, positioned alongside the hub or the main supporting material
of the device, and, bracing the medial side of the said index
finger along the skin surface of the patient or donor just a small
measure below the point of puncture, the penetration of the needle
into the body walls can be steadily made.
9. Soon as the front cannula is felt to have made the correct
venous puncture, watch for the first inflow of blood into cavity X
in order to determine whether the right venous insertion has
succeeded in bringing forth the desirable optimal flow of specimen.
This blood flow can be seen because of the transparency of the main
supporting material wherein cavity X is found.
10. When convinced that the proper flow of blood has ensued from
the vein into the said cavity X, gently push the sample tube at its
base iwth the thumb, while the index finger jointly with the middle
finger are both hooked against the flanged portion of the
VACUTAINER HOLDER so as to enable the easy forward movement of the
said sample tube deep into the barrel of the holder where the
mounted rear cannula pierces through the diaphragmatic area of the
tube's rubber stopper, thereby permitting the physical
inter-communication between the vacuum of the sample tube with the
rear cannular bore which is actually already linked with the
inernal cavity Y of the device. During this phase of operation. the
opening of the elasto-valvular mechanism can be observed affording
the transport of blood from cavity X into cavity Y from where the
specimen is aspirated through the rear cannular bore int the
connected VACUTAINER tube until the desired quantity has been
collected into the tube.
11. Without removing the position of the front cannula inside the
lumen of the vein, gently pull the blood-filled tube from its
engagement with the rear cannula, and then replace another unused
VACUTAINER tube into the barrel of the holder to repeat the same
extraction process until all the tubes for multi-sampling for that
particular patient or donor have all been filled with specimen.
12. With the last container tube still connected with the rear
cannula inside the holder's barrel, the tourniquet can now be
removed, and then, the alcohol-wet cotton is placed at the site of
venipuncture as the front cannula is being pulled away from its
penetration of the body walls.
Because of the capability of the device in adjusting its valvular
aperture sizes to the pressure differential gradients between the
venous side and the vacuum of the sample tube, it may probably
prove conductive for the early removal of the tourniquet, just
after the first sample tube has been installed, without waiting
until all the VACUTAINER tubes for multi-sampling have all been
filled with specimens, on account of the shock-absorbing property
of the elasto-valvular mechanism that can prevent venous wall
collapse by reducing the effects of shock-wave propagation
secondary to the abrupt increment of pressure differential as soon
as the vacuum of each of the pre-evacuated sample tube has been
linked with the system. This advantageous feature would
considerably curtail the discomfort on the part of the patient or
donor due to the concurrently practiced longer duration of
tourniquet application during the process of multi-sample
extraction from the vein.
13. Pressure at the side of venipuncture is applied with sterile
cotton until no further bleeding is attained. The patient or donor,
if able, can be instructed to do this.
14. Gently invert the blood-filled tubes containing anti-coagulants
to ensure proper mixing and thereby prevent clotting of these
particular specimens such as for complete blood count, prothrombin
test and other clinical tests requiring uncoagulated blood. The
rest of the other specimens wherein serum is the important part for
clinical laboratory analysis, the tubes are not shaken and the
blood contents are left to clot before centrifugation.
15. Disengage the poly-sample hupodermic needle from it linkage
with the last tube as well as with the holder, and safely dispsoe
the used needle into a sterilizing container filled with antiseptic
to prevent contamination.
16. Label the tubes properly before proceeding to the next patient
in order to avoid confusion with the other sets of specimen.
* * * * *