Note: Descriptions are shown in the official language in which they were submitted.
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MIXING SYRINGE WITH AND WITHOUT FLUSH
Continuation-in-Part
This Patent Application is a Continuation-in-Part of U.S.
Patent Application number 11/284,504 titled MULTI-CHAMBER,
SEQUENTIAL DOSE DISPENSING SYRINGE, filed by Gale H. Thorne,
Jr. et al_ (Thorne, Jr.) on November 22, 2005; which is a
Continuation-in-Part of U.S. Patent Application number
assembly 10/838,101, titled MULTI-CHAMBER, SEQUENTIAL DOSE
DISPENSING SYRINGE, filed by Howlett, et al. (Howlett) on May
3, 2004, for which a U.S. Patent Number 6,997,910 has been
issued, and, for which an international PCT patent application
number of PCT/US05/14299 was filed April 26, 2005.
Field of Invention
This invention relates to mixing syringes and multi-
chamber syringes and, in particular, to mixing syringes which
,utilize conventional syringe barrels and, in the case of
multi-chamber flush syringes, dispense fluid from each chamber
sequentially.
Description of Related Art
This invention is a Continuation-in-Part of Thorne, Jr.
which discloses multi-chamber syringes which can be used for
sequential delivery of fluids. As this instant invention can
involve a combination of both a mixing syringe and a
sequential fluid delivery application, contents of Thorne, Jr_
are included herein by reference.
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Syringes for storing and mixing materials comprising
diluents in one chamber and either dry (e.g. lyophilized) or
liquid reagents (e.g. medications) in a disparate chamber are
well known. Such syringes provide a means for mixing, while
both materials are kept disparate within the syringe prior to
use. Achieving a mixing syringe in current art has taken many
forms, including frangible diaphragms, special barrel
geometries which permit fluid flow between chambers when a
separating stopper is displaced to a predetermined slotted or
expanded portion of a barrel, telescoping barrels and plugs.
Often some type of special barrel design is utilized. Beyond
the requirement for special barrel design, there may be
performance issues associated with such syringes, such as dead
space and numbers of mixing syringe parts and complexity.
As an example, U.S. Patent 4,041,945 titled MIXING
SYRINGE and issued to Aeneus C. Guiney August 16, 1977
(Guiney) discloses mixing syringe apparatus which employs a
conventional syringe barrel. One chamber for a diluent is
disposed in the syringe barrel. A chamber for material to be
diluted is disposed in a chamber formed in a resilient piston
head. It is noted that such a mixing syringe limits volume of
material which can be diluted and establishes a dead space
relative to a delivered volume.
Generally, within each serial delivery syringe, chambers
are separated by an intermediate sliding stopper or other part
which receives motive force communicated through an
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intermediate fluid from a primary stopper which is part of a
plunger assembly and against which an external force is
applied. For disparate fluids to be dispensed sequentially or
serially, each intermediate stopper must provide a fluid-tight
seal to assure that no inadvertent chamber-to-chamber
communication occurs and that all fluid from a distal chamber
is evacuated from the syringe before dispensing fluid from a
more proximal chamber. Once the distal chamber of the syringe
is so purged, that intermediate stopper must be breached or
bypassed to permit dispensing of the contents of a proximal or
intermediate chamber.
Definition of Terms:
Following is a brief list of clarifying definitions for
terms used in this Application:
assembly n: a device which is made from at least two
interconnected parts
barrel n: a cylindrical elongated portion of a syringe which
is conventionally open on one end to receive a plunger and
stem used for displacing fluid within the barrel and partially
closed at an opposite end except for an orifice through which
fluid is ejected or aspirated
bi-stable adj: a descriptor for a device having two stable
states
clinch n: a structure or device which acts upon a part to
clamp it closed while in contact therewith
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conventional adj: sanctioned by general custom; i.e.
commonplace, ordinary
chamber n: a volumetric portion of a divided barrel
cda.sparate n: when used in conjunction with a liquid volume, a
volume of liquid which is distinctly separate from another
liquid volume
di.fferential pressure (AP) n: a pressure gradient resulting
from unequal pressures exerted upon opposing sides of a
structure; generally as used herein, AP = Pp - Pd
distal adj: a term which depicts placement away from a
reference point (e.g. away from a user of a syringe)
dome n: an arcuately shaped surface (e.g. a hemisphere)
downstream adj: a direction which is consistent with flow out
of a syringe or away from a user
fluid n: a substance (e.g. a liquid and/or gas) which tends to
take the shape of a container
front adj/n: distally disposed or a distally disposed site
(e.g. a front of a syringe comprises the dispensing orifice)
gas n: a fluid which is neither solid nor liquid
liquid n: a fluid which is neither solid nor gaseous,
generally considered to be free flowing like water
non-planar adj: not planar in a resting or stable state
medial adj: occurring away from an outer edge; disposed near
the center of (e.g. disposed away from an edge or periphery
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and in the vicinity of a center of gravity or axis of
symmetry)
Pd n: pressure in a distal chamber or a pressure which is
distally disposed relative to a structure across which a
5 differential pressure is effected
plunger n: a portion of a syringe piston apparatus usually
affixed to a syringe stem which is used to displace fluid
within a syringe barrel
pr3.me v: to fill liquid into a cavity generally by removing
air therefrom (e.g. priming a gas separator)
P. n: pressure in a proximal chamber or a pressure which is
proximally disposed relative to a structure across which a
differential pressure is effected
proximal adj: opposite of distal (e.g. a term which depicts
placement nearer than a reference point)
rear adj: opposite from front (i.e. generally associated with
a part of a syringe barrel which is proximal to a syringe
user)
reflux n: a type of undesired retrograde (upstream) flow of
liquid (e.g. blood into a catheter or the like) from a vessel
in which the catheter or the like resides
separator n: a liquid filter which impedes passage of air
while permitting liquid to flow through the separator
state n: mode or condition of being; when referenced to a
valve assembly, a condition which permits or restricts fluid
flow under predetermined conditions
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sticti.on n: a special case of friction; stiction being the
force required to initiate motion to a resting body, esp. when
stiction is greater than moving friction
stem n: an elongated part which fits within a syringe barrel
and is affixed to a plunger for the purpose of displacing
fluid within the barrel
stop n: a obstruction which is differentiated from friction or
stiction, esp. an obstruction which halts displacement of a
stopper or plunger
stopper n: a stem=free plunger associated with a stopper
assembly or mixing syringe assembly, in the instant invention,
each stopper contains a self=actuating valve
syringe n: a device used for injecting or withdrawing fluids
upstream adj: a direction which is against the direction of
flow from a syringe (opposite of downstream)
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BRIEF SIINgdRRY AND OBJECTS OF THE INVENTION
In brief summary, the currently preferred embodiment of
this novel invention alleviates all known problems related to
providing an effective mixing syringe assembly and, further, a
mixing syringe assembly and multi-chamber, sequential dose
dispensing syringe combination.
Generally, the invention employs a syringe of traditional
design which has a conventional hollow barrel having an
elongated internal cylindrical surface, the barrel surface
comprising an open proximal end and a distal end having a
closed interior about an orifice through which fluid is.
transferred, and a stem and plunger combination, the
combination being disposed to be displaced within said barrel,
for mixing, by application of force, in a predetermined
direction, against the stem; thereby imposing differential
pressures which displace fluid within the barrel.
During mixing, a removable cap is disposed about the
orifice and, in combination with the plunger, fully confines
all fluid and material previously stored within said syringe
barrel between the plunger and cap.
A displaceable valved stopper is disposed within the
barrel between the plunger and the distal end to provide a more
proximal chamber disposed between the plunger and the valved
stopper, thereby providing a container for a first volume of
matter, and a more distal chamber, disposed between the distal
end and the valved stopper as a container for a second volume
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of matter. The first and second volumes of matter are thereby
kept disparate before mixing. Mixing is accomplished by action
of forcing displacement of the stem in the predetermined
direction.
The displaceable valved stopper comprises a normally-
closed valve which yields to an open state when the
predetermined pressure differential is disposed across the
valved stopper. Orientation of the valve determines direction
of application of force upon the stem to open the valve. That
pressure differential which opens the valve causes fluid flow
to be dispensed through the valve, thereby mixing fluid from
one chamber (the dispensing chamber) with fluid resident in the
other (receiving) chamber.
Of critical importance is containment of an elastic fluid
within the more distal chamber wherein energy, resulting from
pressure derived from force applied in the predtermined
direction upon the stem of the syringe, is stored. At least a
portion of the stored energy effects displacement of the valved
stopper in a direction opposite direction of the applied
predetermined force once that force is terminated, thereby
changing size of one chamber relative to the other chamber and
providing opportunity for additional dispensing of fluid
through the valve by subsequent application of force in the
predetermined direction.
In this manner, by repeated application of force on the
stem in the predetermined direction, substantially all matter
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in one chamber is displaced into the other chamber to
accomplish mixing. Prior to mixing it is critical that
contents of the two chambers remain disparate. For this
purpose, a biasing memory element may be provided. Such a
biasing memory element may be provided in place of the stem
within the barrel of the syringe prior to mixing. The biasing
element maintains a differential pressure across the valved
stopper which keeps the valve closed during shipping, storage
and before use.
. Further, in a combination embodiment a valve assembly like
the valve assembly disclosed in Thorne, Jr. is disposed between
the valved stopper and plunger to divide the more proximal
chamber into a middle chamber and a most proximal chamber. The
middle chamber acts as the more proximal chamber the previous
embodiment described. The most proximal chamber is filled with
a fluid which may be used as a flush. All three chambers
retain matter disparate until used. Fluid from the most
proximal chamber is dispensed separately and sequentially
following mixing and dispensing of mixed fluid from the distal
and middle chambers. Of course, the cap is removed prior to
dispensing fluids from the syringe. Dispensing is accomplished
by conventional application of force upon the stem.
More specifically, in a first basic embodiment, the
invention involves at least one (first) distally disposed
displaceable valved stopper which is designed to operate within
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a conventional syringe to separate a most distal chamber from a
more proximal chamber.
In this first embodiment, before dispensing, the distal
chamber generally contains a first fluid volume, which may be a
5 diluent; however, in a second basic embodiment, the distal
chamber may contain a mass or other material to be diluted.
The adjacent, more proximal chamber contains a disparate second
fluid volume or mass of material.
In the first embodiment, an initial state of a closed
10 valve in the first stopper keeps the contents of each chamber
separate from the other until initiation of a mixing step. A
cap which seals the syringe against influent or effluent fluid
flow is disposed to block fluid flow in or out of the syringe
until the mixing step is complete. In this first embodiment, a
15, plunger affixed to a stem of the syringe is used as a forcing
tool both in mixing and in dispensing fluids from the syringe.
Generally, the plunger communicates force, applied against the
syringe stem, to the valved stopper through an intermediate
f luid .
Preferably, the distal face of the valved stopper is
shaped to correspond to the internal shape of the distal end of
the syringe to minimize dead space. All parts which
communicate with the proximal side of the valved stopper are
also shaped to nest or otherwise correspond to the proximal
side of the valved stopper to similarly minimize dead space.
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The valve in the first valved stopper has several
important and critical features. First, the valve remains
absolutely closed in a first state when a first positive AP (a
zero AP being considered positive) is disposed across the
valve, thus keeping fluid or other matter in the chambers
disparate during shipping, storage and prior to mixing.
Second, the valve in the first valved stopper is designed
to become patent to flow of fluid, in the first state, from the
distal chamber into the proximal chamber when a negative AP is
imposed across the valved stopper by proximal displacement of
the stem and plunger within the barrel of the syringe. When
imposing such a negative OP upon the valved stopper, it is
critical that a portion of the fluid in the distal chamber be
gas (e.g. air) to provide an elastically expandable and
compressible component therein.
Thus, when the stem of the syringe is forcibly displaced
proximally, fluid is withdrawn from the proximal chamber
through a patent valve of the first valved stopper. At the
time fluid is being withdrawn from the distal chamber, pressure
in the distal chamber is negative relative to ambient pressure
outside the syringe. Once force is relieved from the stem, a
resulting change in pressure causes the valve to close, and the
first valved stopper is resultingly distally displaced by the
resulting pressure gradients among the distal, and proximal
chamber(s) and ambient pressure outside the syringe. Repeated
application of proximally directed force and resulting proximal
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displacement of the stem ultimately "pumps" substantially all
fluid from the distal chamber and, thereby, displaces the
valved stopper to abut the internal distal face of the syringe
with substantially all of the fluid originally disposed in the
distal chamber being displaced to mix with fluid in the more
proximal(mixing)chamber.
Once the fluids are mixed in the proximal chamber in the
first embodiment, the mixed fluids may be directly dispensed or
further mixed by an alternate step. For the alternate step, a
distally directed force is imposed upon the stem to create a
predetermined positive switching pressure gradient across the
valved stopper while the valved stopper is abutting the
internal distal face of the syringe. Such a pressure gradient
causes the valved stopper to be switched to a second state
which is permissive to distally directed fluid flow through the
valve. Also, for further mixing to occur, the valve in the
second state must then restrict proximal fluid flow when force
is relieved from the stem. In such a case, each time distally
directed force is applied to the stem, after the valve is
switched to the second state, fluid is pumped from the proximal
chamber through the valve into the distal chamber to abet
additional mixing.
Once either mixing step is complete (and the cap is
removed), a distally directed force is applied to the stem,
then, by conventional procedures, gas (i.e. usually air) is
primed from the syringe followed by dispensing of mixed liquid.
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In the case of the mixing syringe assembly and multi-
chamber, sequential dose dispensing syringe combination, two
valved stoppers are employed. The more distal stopper is the
same as the first valved stopper disclosed supra. The second
or more proximal valved stopper is part of a stopper assembly,
an example of which is disclosed in Thorne, Jr., incorporated
herein by reference_ The two stoppers divide the barrel of the
syringe into three chambers. The most distal two chambers
perform the same storage and mixing functions disclosed for the
mixing syringe assembly disclosed supra. The third and most
proximal chamber is generally used for storing a third
disparate fluid, such as, for example, a flush solution.
As disclosed in Thorne, Jr., the stopper assembly
comprises two elements, the second valved stopper and a stopper
stabilizer and gas separator (referenced hereafter as a
"separator"). The valved stopper contains a valve mechanism
held closed by a clinch and is only actuated by a predetermined
positive pressure differential across the valve. Thus, the
stopper assembly may be displaced proximally by action against
the stem and associated plunger to "pump" fluid from the distal
chamber into the next more proximal chamber (which is the
mixing chamber) as disclosed supra. Because the valve of the
valve assembly only opens when displaced to collide with a more
distal end of the syringe (or another stop within the syringe
such as against the first valved stopper), solutions contained
in the mixing chamber and in the most proximal chamber are kept
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disparate during mixing and dispensing of the mixed solution.
Only after the mixed solution is fully dispensed (when the
valve assembly collides and nests against the first valved
stopper) does the valve of the second valved stopper open_
Thus, the following steps are achieved:
1. The syringe stem and plunger are drawn proximally and
released until contents of the most distal chamber are
displaced for mixing into the middle chamber.
2. The contents of the most distal chamber and middle
chamber are allowed to reside in the middle chamber for a
predetermined period of time to assure adequate mixing.
2.a. By an alternate switching of the first valved
assembly valve to a second state, contents of the middle
chamber are permitted to be pumped into the most distal chamber
for further mixing.
3. The cap is removed.
4. Consistent with conventional protocol, the chamber
holding the mixed fluid is purged of air.
5. The syringe is connected to a dispensing site.
6. The syringe stem and plunger are displaced distally to
dispense liquid from the mixing chamber.
7. Once the mixing chamber is empty (the valve assembly
is nested against the first valved stopper), the valve, of the
valve assembly, is opened by an increased positive AP (force
against the stem and plunger) and content of the most proximal
chamber is dispensed.
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Note that, one basic difference between the valved stopper
disclosed in Thorne, Jr. and the second valved stopper is that,
rather than contouring the distal face of the second valved
stopper to correspond to the inner distal face of the syringe
5 barrel (as taught in Thorne, Jr.), the distal face of the
second valved stopper is contoured to nest within the proximal
side of the first valved stopper to minimize dead space as the
mixed solution is dispensed from the syringe prior to actuation
of the valve in the second valved stopper for the purpose of
10 dispensing fluid from the most proximal chamber.
Notably, mixing occurs by applying force upon the syringe
stem in one direction which results in displacement of a valved
stopper in a direction opposite the direction of a force
applied to a stem of the syringe. For this reason, a second
15 embodiment of the instant invention involves a valved stopper
having a normally-closed valve which is permissive to distal
flow when a positive differential force is applied across the
valved stopper. Thus when a positive force is imposed upon the
syringe stem fluid is forced distally th'rough the normally-
closed valve and, once the force is removed, equilibrating
pressures force the valved stopper proximally. Thus, in this
second embodiment, diluent is stored in a more proximal chamber
and medical matter to be diluted is disposed in the distal
chamber. Successive imposition of force producing a positive
pressure differential across the valved stopper displaces fluid
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from the more proximal chamber to the distal chamber where
mixing occurs.
In all embodiments of Thorne, Jr. and this instant
invention, action upon a plunger associated with the syringe
communicates through the most proximal volume of fluid to
displace syringe stopper assemblies. In those valved stoppers
employing bi-state or bi-stable operation, once each valved
stopper is displaced to abut a stop, a resulting positive AP,
causes the associated valve in the abutting valved stopper to
open to permit dispensing of liquid from the chamber which is
just proximal from that valved stopper.
Upon complete evacuation of the liquid from that proximal
chamber and by collision of the next valved stopper with the
distal internal end surface of the syringe (or another stop), a
positive differential pressure across the stopper resulting
from force against the syringe stem causes the valve in the
next valved stopper to be opened to a second state. Thus,
continuous action upon the stem of the syringe permits
sequential -and selective dispensing of liquid contents from
each such proximal chamber following dispensing of fluid from
each more distal chamber. In the embodiment where mixing is
dependent upon a positive differential pressure, there is no
need to switch an associated valve to a second state, as the
valve is already open to dispense fluids from the syringe.
It is important to note that conditions which inhibit
reflux, guard against dispensing gas from the most proximal
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chamber, maintain stability of the valve assembly as it is
displaced within a syringe barrel and assure low resistance to
dispensing flow in the mixing syringe assembly/multi-chamber
syringe combination are the same as for the multi-chamber
syringe, disclosed in Thorne, Jr.
Accordingly, it is a primary object to provide a
displaceable valved stopper which partitions a conventional
commercial syringe to make a mixing syringe assembly.
It is a fundamental object to provide a valved stopper for
a syringe which keeps two disparate fluids apart until the
fluids are mixed by force delivered upon a plunger associated
with a stem of a syringe.
It is another fundamental object, in a first embodiment,
to provide a displaceable valved stopper which has a valve
which, in a first state, becomes patent to fluid flow when a
negative OP is disposed across, the valved stopper.
It is yet another fundamental object, in a second
embodiment, to provide a displaceable valved stopper which has
a valve which, in a first state, becomes patent to fluid flow
when a positive AP is disposed across the valved stopper.
It is an extremely important object to provide a valved
stopper and associated fluid delivery parts within a syringe
which yield a low dead space for dispensed liquid.
It is another important object to provide a valved stopper
having an operable slit valve.
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It is an object to provide a bi-state valve as part of a
valved stopper.
It is a very important object to provide a mixing syringe
assembly and multi-chamber syringe combination having three
disparate chambers.
It is an object to provide a mixing syringe assembly which
has a chamber, which ultimately contains a mixed solution,
which can be purged of air prior to medication delivery.
It is another primary object to provide a valve assembly
which opens to dispense liquid from a most proximal chamber
only after liquid from a more distal chamber has been
dispensed.
It is a basic object to provide a valve assembly which
acts as a liquid filter in the most proximal chamber to deter
gas in a flush solution from being dispensed from the most
proximal chamber.
It is a very important object to provide a separator which
is a stabilizer for an associated valved stopper in a syringe
barrel.
It is an object to provide an interface between a valved
stopper and a separator such that displacement of the valved
stopper likewise displaces the separator.
These and other objects and features of the present
invention will be apparent from the detailed description taken
with reference to accompanying drawings.
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BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a perspective of a two chamber mixing syringe
assembly made according to the instant invention, a syringe of
the syringe assembly comprising a barrel having a traditional
elongated substantially cylindrical shape.
Figure lA is a perspective of the two chamber mixing
syringe assembly seen in Figure 1 with a syringe stem removed
and replaced by a spring assembly which biases pressure against
more distal parts to provide stability for the valve in the
valved stopper in shipping, handling and storage prior to use.
Figure 2 is a perspective of the two chamber mixing
syringe assembly seen in Figure 1 with a valved stopper
disposed in a first state and displaced as fluid is drawn from
a more distal chamber into a more proximal chamber for mixing.
Figure 3 is an exploded view of the two chamber mixing
syringe assembly seen in Figures 1 and 2.
Figure 4 is a distal perspective of a valved stopper which
separates the more distal chamber from the more proximal
chamber in Figures 1 and 2.
Figure 4A is a cross section of the valved stopper seen in
Figure 4 taken along lines 4A-4A.
Figure 5 is a proximal perspective of the valved stopper
seen in F'igure 4.
Figure 6 is a distal perspective of the valved stopper
seen in Figure 4, with a slit valve disposed in a second or
open state.
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Figure 6A is a distal perspective of a valve stopper
similar to the valved stopper seen in Figure 6, but with an
open state which forms a one-way valve about a slit.
Figure 7 is a distal perspective of a plunger which is
5 associated with a stem of the syringe seen in Figures 1 and 2.
Figure 8 is a perspective of the syringe assembly of
Figures 1 and 2 with the valved stopper displaced to abut the
most distal inner front surface of the syringe barrel.
Figure 8A is a perspective of a syringe assembly similar
10 to the syringe assembly=seen in Figure 8 with a valve of a
valved stopper switched to an open state, the valved stopper
displaced proximally relative to the valved stopper seen in
Figure 8.
Figure 9 is a perspective of the syringe assembly of
15 Figure 8 with a cap removed and the valve of the valved stopper
disposed in an open state such that fluid may be dispensed from
the syringe barrel.
Figure 10 is a perspective of the syringe assembly of
Figures 7 and 9 with fluid completely dispensed and the plunger
20 nested into the valved stopper to minimize dead space.
Figure 11 is a perspective of a three chamber mixing and
flush syringe assembly according to the invention which is
similar to the syringe assembly seen in Figure 1, but having a
valve=assembly which separates the more proximal chamber of the
syringe of Figure 1 into a middle chamber and a most proximal
chamber.
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Figure 12 is a perspective of the three chamber mixing and
flush syringe assembly seen in Figure 11, but with the valve
assembly displaced away from the valved stopper to provide a
larger middle chamber than is seen in the middle chamber of
Figure 11.
Figure 13 is an exploded view of the three chamber mixing
and flush syringe assembly seen in Figures 11 and 12.
Figure 14 is an in-line perspective of the valved stopper,
valve assembly and plunger seen in Figures 11 and 12.
Figure 15 is a perspective the valve assembly seen in
Figure 14.
Figure 16 is a perspective of the valved stopper and the
valve assembly, each with a slit valve disposed to an open
state.
Figure 17 is a perspective of the three chamber mixing and
flush syringe assembly seen in Figure 11 with a portion of the
fluid earlier disposed in the distal chamber drawn into the
middle chamber.
Figure 18 is a perspective of the three chamber mixing and
flush syringe assembly seen in Figure 17 with the valved
stopper displaced to abut the inner distal surface of the
syringe barrel.
Figure 19 is a perspective of the three chamber mixing and
flush syringe assembly seen in Figure 18, but with a cap
removed and valve of the valved stopper open for dispensing
fluid from the syringe barrel.
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Figure 20 is a perspective of the three chamber mixing and
flush syringe assembly, seen in Figures 18 and 19, with the
valve assembly nested into recesses of the valved stopper and
with both valves open to permit dispensing of a flush from the
most proximal chamber the barrel.
Figure 21 is a perspective of the three chamber mixing and
flush syringe assembly, seen in Figure 20, with fluid from the
most proximal chamber dispensed, but with the plunger retained
at a non-abutting distance from the valve assembly to guard
against reflux.
Figure 22 is a perspective of a two chamber mixing syringe
assembly similar to the syringe assembly seen in Figures 1-8,
but having a valved stopper molded with a dome inverted
relative to the valved stopper seen in Figures 1-8.
Figure 23 is a perspective of a syringe assembly similar
to the syringe assembly seen in Figure 22 with a valve of a
valved stopper disposed in an open state, the valved stopper
being displaced proximally relative to the valved stopper seen
in Figure 22.
Figure 24,is a distal perspective of the valve stopper of
the syringe assembly seen in Figures 22 and 23 which separates
a more distal chamber from a more proximal chamber in Figure
22.
Figure 25 is a distal perspective of the valve stopper
seen in Figures 22-24 with a valve of the valved stopper
disposed in an open state.
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DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
In this description, primes of numbers are used to
represent parts which are similar, but not identical to other
parts having the same numbers. Reference is now made to
embodiments illustrated in Figures 1-25 wherein like numerals
are used to designate like parts throughout. Note that Figures
1-21 generally disclose elements associated with a first
embodiment of the instant invention while Figures 22-25
disclose elements associated with a second embodiment of the
instant invention.
Reference is now made to Figure 1 wherein a two chamber
mixing syringe assembly 10 made according to the instant
invention is seen. Mixing syringe assembly l0 is assembled
using a conventional syringe 20 which comprises a traditional
elongated, cylindrical barrel 30, a stem 40 and a plunger 50
associated with stem 40.
Plunger 50, as is the case for most syringe plungers, is
disposed within a hollow cylinder 60 of barrel 30 and is
sufficiently close fitting to be fluid tight and wipe liquid
from an inner surface 70 of cylinder 60 when displaced through
barrel 30. Further, barrel 30 is closed at a distal end 80,
except for a fluid dispensing orifice 90 (seen in Figures 9 and
10)_
Note, that distal end 80 has an interior surface 92 which
is contoured to maximize effluent flow and minimize dead space
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to thereby minimize fluid retained in barrel 30 as a plunger or
stopper is displaced to abut distal end 80. During the mixing
phase, orifice 90 is closed and sealed by a removable cap 100.
Preferably, orifice 90 and cap 100 have associated luer and
luer-lock fittings for fluid tight connection.
Disposed within barrel 30 between plunger 50 and interior
surface 92 is a valved stopper 110. Valved stopper 110 divides
space within barrel 30 into two chambers (i.e. distal chamber
120 and proximal chamber 130). Though proximal chamber 130 is
seen to be much smaller in Figure 1 than distal chamber 120,
such is not necessarily always the case. The relative size of
chamber 120 to chamber 130 may vary dependent upon
concentrations and quantities of material to be mixed.
To mix fluids contained in chamber 120 with material
contained in chamber 130, stem 40 (and plunger 50) are
displaced in the direction of arrow 140. As may be noted in
Figure 1, contents of chamber 120 include a liquid 150 (usually
a diluent) and a small amount of gas 160 (likely air and
diluent vapor). Smaller chamber 130 may contain a lyophilized
solid and gas or a fluid. Contents of chamber 130, either the
lyophilized solid or a fluid, are destined to be diluted by
liquid 150 from chamber 120. Gas 160 may be small in volume
compared to liquid 150, but it is prudent to have that small
elastic material volume in chamber 120 to facilitate creation
of negative pressures in chamber 120 during the mixing process.
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Reference is now made to Figure 4 wherein a distal side
162 valved stopper 110 is seen. Though other kinds of valved
bi-state stoppers may be employed within the scope of the
instant invention, valved stopper 110 comprises a medially
5 disposed dome 170 which has a concave surface 172, relative to
distal side 162. Centrally disposed across dome 170 is a slit
180, which remains closed when a positive pressure gradient of
a predetermined magnitude (measured from proximal side 182 to
distal side 162) is imposed thereupon.
10 Dome 170 is better seen in Figure 4A to comprise a convex
proximal surface 184 juxtaposed concave surface 172. As seen
in Figure 5, proximal side 182 comprises a cylindrical inner
surface 186 which forms a hollow well 188 leading to dome 170.
Valved stopper 110 comprises a ribbed cylindrical exterior
15 surface 190 which is sized and shaped to fit into barrel 30 and
displace fluids within into barrel 30 in the same manner as
plunger 50.
When a negative pressure gradient is imposed upon valved
stopper 110, by displacing stem 40 in direction of arrow 140
20 (see Figure 1), that negative pressure is also disposed across
dome 170. Under such conditions, dome 170 "balloons" and slit
180 opens to permit a portion of the fluid (liquid 150 and gas
160) disposed in chamber 120 to pass into chamber 130. When
the displacing force is removed from stem 40, equilibrating
25 forces of ambient air and previously internally generated
negative pressures displace plunger 50 distally to the position
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from which it was earlier displaced and, because slit 180
closes when equilibrating forces impose a positive pressure
gradient across valved stopper 110, stiction and friction are
overcome to displace valved stopper 110, distally, as seen in
Figure 2.
Successive proximal displacements of stem 40 result in
additional flow of fluid from chamber 120 into chamber 130.
Each subsequent release of force from stem 40 results in distal
displacement of valved stopper 110. Ultimately, substantially
all of the fluid originally disposed in chamber 120 is
displaced into chamber 130 to mix with the contents thereof.
At this point, valved stopper 110 abuts distal interior surface
92, as seen in Figure 8. Preferably, distal face 162 of valved
stopper 110 is contoured to minimize dead space and, thereby,
maximize mixing of contents of chambers 120 and 130.
Form and shape of discreet parts of mixing syringe
assembly 10 are seen in Figure 3. Cap 100 is securely but
releasibly affixable to syringe barrel 30. Syringe barrel 30
is the form of a cylinder (hollow cylinder 60) of substantially
constant diameter. Valved stopper 110 fits into barrel 30 in a'
manner similar to the way plunger 50 fits into barrel 30.
Plunger 50 is either affixed to stem 40 prior to insertion of
plunger 50 into barrel 30 or is attached just before use as is
disclosed hereafter. Special attention should be made to form
of a distal portion 192 of plunger 50, which is better seen in
Figure 7.
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As earlier mentioned, plunger 50 has a cylindrical ribbed
exterior surface (numbered 194 in Figures 3 and 7) which
provides a fluid tight interface with interior barrel surface
60. Distal from surface 194, portion 192 comprises a solid
cylindrical section 196 which is sized and shaped to nest
within well 188 (see Figure 5). Also portion 192 abruptly ends
in a distal front face 198 which is shaped and contoured to fit
against a proximal face portion 200 of well 188 of which
stopper 110 (again, see Figure 5) to thereby dispense any
remaining fluid from well 188 when portion 192 is completely
nested therein.
As is disclosed in detail hereafter, dome 170 inverts
under force of a predetermined positive pressure gradient to an
inverted or switched state as seen by examples of domes 170 and
170' in Figures 6 and 6A. For this reason, portion 192 has a
nose section 202 (again see Figure 7) seen to be medially,
distally protruding out of face portion 200. Portion 200 is
sized and shaped to fit within a hollow formed by inverting
dome 170 or 170' to thereby expel remaining fluid therefrom
when portion 192 is completely nested therein.
When valved stoper 110 is displaced to abut distal end 92
as seen in Figure 8, dome 170 and slit 180 are initially
disposed as seen in Figures 4 and 4A. A predetermined positive
pressure gradient disposed across valved stopper 110, when
valved stopper 110 is abutting distal end 92, displaces or
switches dome 170 to a second state (seen in Figures 6 and 6A).
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Most commonly, cap 100 is removed from syringe 20 before
applying a force upon stem 40 which provides the pressure
gradient to switch either dome 170 or 170'.
Once mixing is considered complete, cap 100 is removed
preparatory to dispensing fluid from barrel 30. As seen in
Figure 9, force is applied to switch dome 170 to open slit 180
when a positive pressure is applied (in direction of arrow 210)
and fluid is dispensed from syringe 20 as seen in successive
steps in Figures 9 and 10 (in the same manner as fluid is
dispensed from a conventional, single-chamber syringe. Note,
in Figure 10 that plunger 50 is well nested into valved stopper
110 to assure substantially all fluid has been eliminated from
syringe 20.
In some cases, however, there may be fluids, disposed
within chamber 130 after completing an initial mixing step, for
which additional agitated mixing is desired. In this case,
design of a dome, such as dome 170' seen in Figure 6A, may be
used. Dome 170' has a thinned area 204 disposed about a slit
180'. When dome 170' is switched, material of thinned area 204
collapses to form a"duck-bill" like valve 206. So formed,
valve 206 opens to a positive pressure gradient across
associated valved assembly 110 and closes when an imposed
pressure gradient is either negative or zero.
Thus, imposing a positive force on stem 40 in the
direction of arrow 210, when valved stopper is disposed as seen
in Figure 8, forces a change in dome 170' to the state seen in
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Figure 6A. Continuing force in the same direction drives fluid
from chamber 130 back into chamber 120. By applying successive
iterations of such force upon stem 40, substantially all fluid
is pumped out of chamber 130 into chamber 120 as seen in Figure
BA.
As disclosed supra, once mixing is complete, cap 100 is
removed and fluid is dispensed in the same manner as with a
conventional, single-chamber, syringe. While, in the case of a
dome 170', valved stopper 110 and plunger 50 are already nested
and operate as a single plunger part to dispense fluid from
chamber 120. In the case of dome 170 (see Figure 9), plunger
50 is distally displaced in direction of arrow 210 to dispense
mixed fluid through valved stopper 110.
Reference is now made to Figure 1A wherein stem 40 (see
Figure 1) is removed from plunger 50. In place of stem 40, a
biasing memory element (e.g. in the form of spring 212)
produces a biasing force and resulting positive pressure
gradient across valved stopper 110 and associated dome 170 (see
Figure 4A). Spring 212 is kept in place by a clip 214 affixed
in bayonet fashion to flanges 216 of syringe barrel 20. So
disposed, spring 212 maintains sufficient pressure across dome
170 to keep slit 180 closed.under shipping, storage and other
conditions prior to use. To use syinge assembly 10, clip 214
and spring 212 are removed before use and stem 40 is affixed to
plunder 50. Such stem and plunger attachments are well known
in the syringe art.
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Reference is now made to Figure 11 wherein a three
chamber, combination mixing and flushing syringe assembly 300
is seen. The combination forming syringe assembly 300 is
assembled using a conventional syringe 20 which comprises a
5 traditional elongated, cylindrical barrel 30, a stem 40 and a
plunger 50' associated with stem 40.
As disclosed supra, plunger 50', as is the case for most
syringe plungers, is disposed within a hollow cylinder 60 of
barrel 30 and is sufficiently close fitting to be fluid tight
10 and wipe liquid from inner surface 70 of cylinder 60 when
displaced through barrel 30. Further, barrel 30 is closed at a
distal end 80, except for a fluid dispensing orifice 90 (seen
in Figures 13 and 19-21).
Note, that distal end 80 has an interior surface 92 which
15 is contoured to maximize effluent flow and minimize dead space
to thereby minimize fluid retained in barrel 30 as a plunger
(when there is no intermediate valved stoppers) is displaced to
abut distal end 80. During the mixing phase, orifice 90 is
closed and sealed by removable cap 100. Preferably, orifice 90
20 and cap 100 have associated luer and luer-lock fittings for
fluid tight connection, as anticipated supra.
Disposed within barrel 30 between plunger 50' and interior
surface 92 is a valved stopper 110. As disclosed supra, valved
stopper 110 divides space within barrel.30 into two chambers
25 (i.e. chamber 120 and chamber 130). Chamber 130 is further
divided, by a valve assembly 310, into a middle chamber 130'
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and a most proximal chamber 320. As related supra, although a
chamber proximally disposed relative to chamber 120, such as
chamber 130', is seen to be much smaller in Figure 11 than
chamber 120, such is not necessarily always the case. The
relative size of chamber 120 to chamber 130' may vary dependent
upon concentrations and volumes of solutions to be mixed.
To mix fluids contained in chamber 120 with fluids
contained in chamber 130', stem 40 (and plunger 50' and valve
assembly 310) are displaced in the direction of arrow 140. As
may be noted in Figure 11, contents of chamber 120 include a
liquid 150 (usually a diluent) and a necessary small amount of
gas 160 (likely air and diluent vapor). Smaller chamber 130'
may contain a lyophilized solid and gas or a fluid. Each of
the lyophilized solid or the fluid is destined to be diluted by
liquid 150 from chamber 120. Gas 160 may be small in volume
compared to liquid 150, but it is prudent to have that small
volume to facilitate creation of negative pressures in chamber
120 during the mixing process.
It is important to note that valve assembly 310 operates
in a manner identical to a valve assembly disclosed in Thorne,
Jr. (referenced as valve assembly 550, therein). Valve
assembly 550 is assembled using a valved stopper 580 and a
separator 700, as numbered in Thorne, Jr. As disclosed in
Thorne, Jr., a flush syringe employing valve assembly 550 may
be used in a manner identical to a standard or conventional
syringe. For this reason, valve assembly 310 and fluid content
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330 in most proximal chamber 320 may, operationally relative to
displacement of valved stopper 110, be considered to be a
mechanical extension of plunger 50'. Therefore, all disclosure
relative to mixing of contents of chambers 130 and 120 for
syringe assembly 10 is relevant and the same as that for
syringe assembly 300 and associated chambers 130' and 120.
Note, as seen in Figures 14-16, valve assembly 310 is
assembled using a valved stopper 340 and a separator 370. A
singular difference between valved stopper 340 and valved
stopper 580 as disclosed in Thorne, Jr. is an elongated front
section 350 of valved stopper 340'as seen in Figures 14-16.
Front section 350 is sized and shaped to nest within well 188
(see Figures 4A and 5) as portion 192 of plunger 50 so nests in
syringe assembly 10 (see Figures 8A and 10). However, valved
stopper 340 comprises a bi-stable slit valve 376 having a dome
374 which inverts when switched (see Figure 14 prior to
switching and Figure 16 after switching). Note also, that a
switched dome 374 provides a bulbous protrusion of front
section 350 which expels fluid from well 188, in the same
manner that nose section 202 does for plunger 50. Gas
separator 370 is functionally identical to separator 700 of
Thorne, Jr. Plunger 50' preferably has a flat or planar distal
face 380.
Order of assembly of parts to make mixing syringe assembly
300 is seen in Figure 13. Valved stopper 110 is displaced into
barrel 30 to close most distal chamber 120, followed by
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insertion of valve assembly 310 (made from valved stopper 340
and separator 370) to form middle chamber 130' and, finally,
insertion of plunger 50' to close most proximal chamber 320.
Chambers 120, 130' and 320 are seen in Figure 12. Separator
370 is seen assembled into valved stopper 340 in Figure 15.
Valved stoppers 110 and 340 are seen in Figure 16 with domes
170 and 374 inverted to a second state with slits 180 and 376
open. Such is the case, when liquid is being dispensed from
chamber 320 as seen in Figures 20 and 21 and disclosed in more
detail hereafter.
Reference is now made to Figure 17 wherein volume of fluid
in middle chamber 130' is seen to be increased from volume of
material in chamber 130' in Figure 11 by successive pulls in
direction of arrow 140 of stem 40. Note that volume of chamber
320 in Figure 17 is substantially the same as volume of chamber
320 in Figure 11. This is because there is no material change
in chamber 320 resulting from success pulls on stem 40.
Ultimately, as seen in Figure 18, valved stopper 110 is
displaced, by successive pulls on stem 40, to abut distal end
80 of syringe barrel 30. At this point, when mixing is
considered complete, cap 100 is removed, as seen in Figure 19.
Forcing stem 40 distally, first dispenses fluid from chamber
120 after inverting dome 170 and opening slit 180. After
chamber 120 is emptied, dome 374 is inverted (see Figure 16)
and slit 376 is opened to permit emptying of chamber 320 as
seen in Figure 20. Finally, substantially all fluid desired to
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be effluent is dispensed as seen in Figure 21. Note, that
plunger 50' is not in contact with valve assembly 310 at the
end of the dispensing cycle. Such is preferred to eliminate
the possibility of reflux.
An alternate embodiment of a mixing syringe assembly 400
is seen in Figures 22-25. In this embodiment, a material to be
mixed or diluted is initially disposed in a distal chamber 120.
A diluent is disposed in a more proximal chamber 130, just
opposite of the material/diluent disposition of Figures 1-21.
However, it is emphasized that mixing dispositions and methods
disclosed for this embodiment are applicable to associated
dispositions and methods disclosed for syringe assemblies 10
and 10', supra. A simple change in geometry or operation in a
valved stopper provides for changes in operative procedures
disclosed hereafter.
Reference is now made to Figure 22 wherein a mixing
syringe assembly 400 is seen. In Figure 22, a material to be
diluted is disposed in chamber 120 between a valved stopper
170" and interior surface 92 of distal end 80 of syringe 20. A
diluent is disposed in chamber 130 between valved stopper 170"
and a plunger 50. It is important to note that plunger 50 and
valved stopper 170" have the same nesting characteristics as
disclosed supra for plunger 50 and stopper 110.
As disclosed supra, distal end 80 of syringe 20 has an
interior surface 92 which is contoured to maximize effluent
flow and minimize dead space to thereby minimize fluid retained
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in barrel 30 as a plunger or stopper is displaced to abut
distal end 80. During the mixing phase, orifice 90 is closed
and sealed by a removable cap 100. Preferably, orifice 90 and
cap 100 have associated luer and luer-lock fittings for fluid
5 tight connection.
Disposed within barrel 30 between plunger 50 and interior
surface 60 is a valved stopper 110'. Valved stopper 110'
divides space within barrel 30 into two chambers (i.e. distal
chamber 120 and proximal chamber 130). In this embodiment,
10 chamber 120 is seen to be much smaller in Figure 22 than distal
chamber 130, as the diluent is anticipated to be stored in
chamber 130. Such is not necessarily always the case. The
relative size of chamber 130 to chamber 120 may vary dependent
upon concentrations and quantities of material to be mixed.
15 To mix fluids contained in chamber 130 with material
contained in chamber 120, stem 40 (and plunger 50) are
displaced in the direction of arrow 210. As may be noted in
Figure 22, contents of chamber 130 include a liquid 150
(usually a diluent) and a small amount of gas 160 (likely air
20 and diluent vapor). Smaller chamber 120 may contain a
lyophilized solid and a necessary volume of gas 402 or a fluid
and gas 402. Contents of chamber 120, either the lyophilized
solid or a fluid, are destined to be diluted by liquid 150 from
chamber 130. Gas 402 may be small in volume compared to other
25 contents of chamber 120, but it is prudent to have that small
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elastic material volume in chamber 120 to facilitate the mixing
process.
Reference is now made to Figure 24 wherein a distal side
162' valved stopper 110' is seen. Though other kinds of
normally-closed valved stoppers may be employed within the
scope of the instant invention, valved stopper 110' comprises a
medially disposed dome 170" which has a convex surface 172',
relative to distal side 162'. Centrally disposed across dome
170" is a slit 180', which remains closed when a negative or
zero pressure gradient (measured from proximal side 182' to
distal side 162') is imposed thereupon.
Generally, other than dome 170", valved stopper 110' has
the same physical dimensions and characteristics as those of
valved stopper 110. When a positive pressure gradient is
imposed upon valved stopper 110', by displacing stem 40 in
direction of arrow 210 (see Figure 22) that negative pressure
is also disposed across dome 170". Under such conditions, dome
170" "balloons" and slit 1801 opens to permit a portion of the
fluid (liquid 150 and gas 160) disposed in chamber 130 to pass
into chamber 120. When the displacing force is removed from
stem 40, equilibrating forces of ambient air and previously
internally generated pressures displace plunger 50 proximally
to the position from which it was earlier displaced and,
because slit 180' closes when equilibrating forces impose a
negative pressure gradient across valved stopper 110', stiction
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and friction are overcome to displace valved stopper 110',
proximally.
Successive distal displacements of stem 40 result in
additional flow of fluid from chamber 130 into chamber 120.
Each subsequent release of force from stem 40 results in
proximal displacement of valved stopper 110'. Ultimately,
substantially all of the fluid originally disposed in chamber
130 is displaced into chamber 120 to mix with the contents
thereof. At this point, valved stopper 110' abuts plunger 50,
as seen in Figure 23.
Once all fluid is emptied from chamber 130 into chamber
120 and mixing is complete, cap 100 is removed.
Interestingly, there is no need for the valve, associated with
dome 170", to be switched to a second state, other than an open
state in this embodiment, to dispense fluids from syringe 20.
Interestingly, once mixing has completed in syringe assembly
400, there is substantially no fluid yet to be displaced
through valved stopper 110', as valved stopper 110' is then
displaced to abut plunger 50. Therefore, cap 100 simply has to
be removed and stem 40 and plunger 50 displaced distally to
dispense mixed fluid from mixing syringe assembly 400. Also a
negative pressure bias is best used to keep material in
chambers 120 and 130 disparate during shipping, handling and
otherwise before use.
The inventions disclosed herein may be embodied in other
specific forms without departing from the spirit or essential
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characteristics thereof. The present embodiments are therefore
to be considered in all respects as illustrative and not
restrictive, the scope of these inventions being indicated by
the appended claims rather than by the foregoing description,
and all changes which come within the meaning and range of
equivalency of the claims are therefore intended to be embraced
therein.
What is claimed and desired to be secured by Letters
Patent is:
