Stopcock having axial port for syringe twist actuation

Fluid handling – Systems – Multi-way valve unit

Reexamination Certificate

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Details

C222S387000

Reexamination Certificate

active

06457488

ABSTRACT:

STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT
(Not Applicable)
BACKGROUND OF THE INVENTION
The present invention relates generally to stopcocks, and more particularly to a stopcock having an axially rotatable core.
A stopcock is a cock or valve for stopping or regulating the flow of a fluid (including liquids and/or gasses). In medicine, a stopcock is most typically used for regulating the flow of intravenous (“IV”) fluids or medications into, or out of, a patient as part of an intravenous system. In this regard, stopcocks provide a quick and sterile way for diverting intravenous fluid flow or medication into a patient by changing the flow path in the IV line system.
A stopcock can also be used to divert fluids or air into devices, such as for filling skin expanders with fluid or air during skin grafting, for filling breast implants with saline during breast augmentation procedures, for diverting spinal fluid into a manometer to measure spinal fluid pressure during a spinal tap, and for diluting viscous packed red blood cells with saline to make them less viscous for subsequent rapid infusion into the patient during transfusions.
Stopcocks are frequently used as a needle-less intravenous injection port. That is, once the initial IV injection port has been opened using a first needle, subsequent injections and infusions are possible through the same injection port via a stopcock having three ports separated by a shut off valve. Stopcocks provide an inexpensive method of avoiding needle-stick injuries and for a clinician to comply with the FDA mandate “to use needle-less injection techniques whenever possible”. Typically, stopcocks are formed of injection molded plastic. As such, stopcocks are inexpensive and disposable after use on a single patient.
Early stopcock designs were simply used as “on and off” valves to start or stop intravenous infusions. Such designs contained two ports, an inlet port and an opposing outlet port. A lever extending from between the two ports was used as a shut off lever. Fluid was configured to only flow between the two ports. These first stopcocks designs were designated as two-port, one-way stopcocks.
Another prior art stopcock design includes a stopcock body with three ports which are arranged in a T-shaped configuration, and a stopcock core having a lever extending radially from an axial portion. The ports can be selected at the option of the user by rotating the lever to a position determined by the direction of desired flow. A “stop” tab is disposed on the stopcock body which prevents the lever of the stopcock from being turned to a position where all three ports are open and flow into one another at one time, i.e., such that the T-shaped path of the body and the T-shaped path of the core are fully aligned. Because fluid can flow three different ways, these stopcocks are designated as three-port, three-way stopcocks.
Referring now to
FIG. 1A
, there is depicted a prior art stopcock
2
which is a three-port, four-way stopcock. It does not have a stop tab as in the threeport, three-way stopcock to prevent the lever from being turned to a position opposite the right angled port. The stopcock
2
includes a body
4
having an entry port
6
, an exit port
8
and an injection port
10
, and a core
12
. The core
12
includes a rotating axial portion
14
connected to a lever
16
.
Referring to FIG.
1
B and
FIG. 1C
, the axial portion
14
of the core
12
has a first flow channel
18
, a second flow channel
20
and a third flow channel
22
which form a confluent “T” configuration. The lever
16
generally includes the word “off”
24
and an arrow
26
molded on its upper surface to show which direction fluid will not flow. The arrow
26
and the word “off”
24
do not directly indicate to the user which way the medication or fluid will flow.
The stopcock
2
is a four-way stopcock because fluid can flow in four different ways. First, when the lever
16
points toward the entry port
6
, fluid can flow between the injection port
10
and exit port
8
. Second, when the lever
16
points toward the injection port
10
, fluid can flow between the entry port
6
and exit port
8
. Third, when the lever
16
points toward the exit port
8
, fluid can flow between the entry port
6
and injection port
10
. Finally, when the lever
16
points opposite the injection port
10
, i.e., toward no port, fluid can flow between all three ports
6
,
8
,
10
at one time.
Referring to
FIG. 2
, there is depicted the body
4
of stopcock
2
. The entry port
6
, exit port
8
and injection port
10
are located in a single horizontal plane and are confluent at a central chamber
28
, which is filled with the axial portion
14
of the core
12
when the stopcock
2
is assembled. The entry port
6
has a female luer lock connector
30
and is the main fluid entry end of the stopcock
2
. It usually is connected to a male luer-lock connector
32
from an IV set connected to a bag of an IV fluid. The exit port
8
has a male luer lock or luer slip connector
32
and is the fluid exit end of the stopcock
2
and is usually connected to a female luer lock connector
30
of an IV extension set which ultimately connects to an IV catheter in a patient. The injection port
10
protruding perpendicularly from the middle of the straight line flow path formed by the entry port
6
and exit port
8
has a female luer lock connector
30
and is used for adding medication or fluids to the IV system.
Referring to
FIG. 3
, there is depicted a core
12
having the axial portion
14
and the lever
16
. The lever
16
rotates in a horizontal plane which is parallel to the horizontal plane formed by the three fluid flow ports
6
,
8
and
10
. The procedure a clinician must follow to perform a typical IV injection or infusion using a conventional three-port, four-way stopcock
2
is fraught with difficulty and risk. An examination of this procedure makes clear the need for an improvement, such as that of the present invention described further below.
A typical intravenous setup using a three-port, four-way stopcock
2
has the exit port
8
typically connected to an IV extension tubing which is subsequently connected to an IV catheter in the patients vein. The entry port
6
is connected to a main IV administration set which is in turn connected to a bag of IV fluid, and the injection port
10
normally has a syringe or a secondary IV fluid line connected to it. When a syringe is attached to the injection port
10
, the bulk and length of the syringe requires that the syringe-stopcock assembly sits on a surface wherein a single plane is formed by the flow ports
6
,
8
,
10
of the stopcock
2
and the attached syringe. The axial portion
14
then extends vertically upward from, and the lever
16
rotates in a plane parallel to, that surface. To turn the lever
16
in a desired direction, a first hand of a clinician is held palm up in a horizontal plane, with the fingers pointing upward in a vertical direction, to stabilize the syringe-stopcock assembly, and a second hand of the clinician is held above the lever
16
, with fingers pointing in a downward, vertical direction, for grasping and rotating the lever
16
.
This prior art stopcock arrangement is awkward for the clinician. With the first hand below and the second hand above the stopcock
2
, the clinician must first determine which way to turn the lever
16
to obtain the desired fluid flow, and then he or she must turn it in the correct direction, either clockwise or counter-clockwise, with fingers of the second hand. When the clinician is assured that the stopcock
2
is secure in the grasp of the first hand only, the second hand releases the lever
16
and grasps the barrel of the syringe attached to the injection port
10
. The second hand then pushes or pulls the plunger of the syringe to give an injection of medication or to aspirate fluid. The second hand must next move from the syringe barrel back to its previous position grasping the lever
16
of the stopcock
2
and rotating it back to its origin

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