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Description  |
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BACKGROUND OF THE INVENTION
1. Field of the Invention
Many techniques and various apparatus for administration of various fluids
intravenously into the body for a variety of purposes are well known in
the art. Solution administration devices are commonly known as
intravascular or "IV" systems and generally include a tubular flow line of
selected length having a spike at the upper end which may be inserted into
an IV solution bag or bottle and a catheter tip at the opposite end for
infusing fluid from the bag or bottle into a patient's vein or artery. The
flow line or tube also typically includes a flow regulator in the form of
a drip chamber and an automated or a thumb-operated device for controlling
the rate of fluid flow from the bag or bottle into the flow chamber and to
the patient. Variations of this IV system are used during heart
catheterization procedures, where a catheter is inserted in a patient's
artery or veins, extended into the heart or other area of investigation
and a supply of diagnostic radiopaque contrast media is injected from a
manifold into the vascular system for angiography in this area. The
contrast media is conventionally used for angiography throughout the
cardiovascular system, including cerebral and peripheral arteriography,
coronary arteriography, ventriculography and the like. Intravascular
injection of the radiopaque diagnostic agent contrast media opacifies
those vessels in the path of flow of the contrast media, permitting
radiographic visualization of the internal structures of the human body.
Although the contrast media is particularly well indicated and effective
for angiography throughout the cardiovascular system, it is very
expensive.
During normal catheterization procedures where contrast media is used, a
bottle of contrast media is typically suspended and spiked by one end of a
conventional IV apparatus, the opposite end of which is attached to a
manifold to facilitate injection of contrast media into the area of
investigation at the proper time. Each such procedure requires varying
amounts of contrast media and upon completion of each procedure, the IV
tubing and unused contrast media, still in the contrast media bottle, are
discarded, regardless of the quantity of contrast media remaining in the
bottle. This procedure is necessary to avoid the possibility of
contamination of the contrast media remaining in the bottle due to
pathogens which may reverse-flow by reflux through the IV tubing from the
patient into the contrast media. This normal operating technique
frequently results in a significant expensive waste for many
catheterization procedures, depending upon the quantity of contrast media
remaining in the dispensing bottle after the procedure has been completed.
2. Description of the Prior Art
Various types of intravenous systems are well known in the art. Early such
apparatus are detailed in U.S. Pat. No. 2,866,457, dated Dec. 30, 1958, to
R. C. Moore; U.S. Pat. No. 2,999,499, dated Sep. 12, 1961, to R. H.
Willet; U.S. Pat. No. 3,001,525, dated Sep. 26, 1961, to G. E. Hendricks;
U.S. Pat. No. 3,057,350, dated Oct. 9, 1962, to C. C. Cowley; U.S. Pat.
No. 3,533,400, dated Oct. 13, 1970, to William E. Polich; U.S. Pat. No.
3,776,229, dated Dec. 4, 1973, to Charles J. McPhee; U.S. Pat. No.
3,951,145, dated Apr. 29, 1976, to B. L. Smith; and U.S. Pat. No.
4,055,176, dated Oct. 25, 1977, to I. H. Lundquist. U.S. Pat. No.
4,078,563, dated Mar. 14, 1978, to Robert D. Tuseth, details a "Disc Valve
In A Container For Dispensing Liquids". The patent describes an improved
disc valve which includes at least two upstanding posts adjacent an outlet
passage in the bottom of the container and a floatable disc member with
apertures near its periphery, through which the posts extend. The posts
are fitted with disc-retaining stops at the upper end and position the
disc, and the relationship between the size of the apertures and the
thickness of the posts assures that the disc will seat over the outlet
passage to prevent the passage of air when all the liquid has been
dispensed. U.S. Pat. No. 4,175,558, dated Nov. 27, 1979, to John M. Hess,
III, details a "Parenteral Liquid Administering Device" which includes an
enlarged chamber for receiving liquid from a source. A bottom flow valve
in the chamber controls flow from the chamber, the valve having an
air-tight, sealed float system. U.S. Pat. No. 4,325,368, dated Apr. 20,
1982, to E. Kaemmerer, details an infusion device having a dual chamber
with two dispensing mechanisms for dispensing two fluids from the
chambers. U.S. Pat. No. 4,425,123, dated Jan. 10, 1984, to F. Di Salvo,
details a "Parenteral Liquid Application Apparatus". The apparatus
includes a liquid flow control device fitted with a membrane which
intermittently closes and opens flow communication from beneath the
dripping tube. A cannula serves to apply the liquid to the patient, the
side of the membrane remote from its control side being connected by a
capillary tube to the interior of the dripping tube to equalize the
pressure changes occurring on both sides of the membrane as the liquid
level and supply vessel decreases. The flow rate is initially adjusted by
lowering the level of the liquid stabilization device with respect to the
level of the dripping chamber. U.S. Pat. No. 4,428,383, dated Jan. 31,
1984, to W. A. DeVoom, details a "Manifold for Monitoring Hemodynamic
Pressure". The manifold assembly includes a base having first, second and
third flush valves mounted thereon. A first three-port stopcock is also
mounted on the base and has one of its ports in fluid communication with
the first flush valve. One of the ports is in fluid flow communication
with an arterial catheter and one of the ports is in fluid communication
with a pressure monitoring device for determining arterial pressure. The
first T-connector is fastened to the second flush valve and a second
T-connector is fastened to the third flush valve. A second three-port
stopcock is mounted on the base with one of its ports in fluid flow
communication with the second flush valve through the first T-connector.
One of the ports of the second three-port stopcock is in fluid flow
communication with the third flush valve through the second T-connector.
U.S. Pat. No. 4,534,757, dated Aug. 13, 1985, to Leo Geller, details a
device for releasing an active ingredient into a liquid flow passing
through a system for parenterial application of the ingredient. The device
includes a receptacle having two half shelves and subdivided by a ribbed
aluminum foil into two chambers with an inlet at its upper end and an
outlet at the lower end. The chambers have vents at their upper ends and
one of the chambers contains two overflows, a first one of which empties
into the outlet while the second overflow empties into the other chamber.
In the latter chamber, there is present a further overflow which also
empties into the outlet, as well as a plate-shaped carrier charged with
the active ingredient to be released. The liquid flows from the inlet by
means of the first chamber and the second overflow into the other chamber
and from there upwardly past a carrier charged with the active ingredient
and onward by means of a third overflow and the other chamber into the
outlet. U.S. Pat. No. 4,548,598, dated Oct. 22, 1985, to Felix Theeuwes,
details a Parenteral Agent Dispensing Equipment which includes a drip
chamber and a formulation chamber. The formulation chamber includes a wall
surrounding an internal space and has an inlet for admitting a liquid into
the formulation chamber and an outlet for letting an agent formulation
leave the formulation chamber. The chamber houses an agent delivery system
for releasing a beneficial agent into a liquid that enters the chamber.
U.S. Pat. No. 4,734,091, dated Mar. 29, 1988, to William J. Boyle, et al,
details a "Filtered Manifold Apparatus and Method For Ophthalmic
Irrigation". The device is designed to provide ophthalmic irrigation by
sterile filtered irrigation fluid into the eye at high flow rates. The
apparatus includes a filter capable of removing particles on the order of
0.8 microns and preferably as small as 0.22 microns. A distribution
manifold facilitates the flow of fluid from a common reservoir
sequentially to multiple recipient sites. U.S. Pat. No. 4,750,643, dated
Jun. 14, 1988, to Theodore S. Wortrich, details a "Sterile Fluid
Dispensing System and Method". The system is disposable to enable a
succession of individuals to be supplied with a sterile medical solution
during operative and other procedures. The system uses a number
spaced-apart, penetrable, elastomerically sealed funnels branching from an
outlet from the solution container or attached drip chamber. A standard
sterile administration set having a spike end may be inserted into the
seal of a first funnel to provide flow to a first individual. After the
first procedure is completed, the conduit to the first funnel is clamped
and the sequence is repeated, but with the spiked end of a second
administration set inserted for supply to a second individual. The
sequence may be repeated for a selected number of branches. U.S. Pat. No.
4,858,619, dated Aug. 22, 1989, to Marie A. Toth, details an "Intracranial
Pressure Monitoring System". The device includes a first valve having a
first input port and first and second output ports, with the first output
port adapted for connection to a drainage collection bag. A tube connects
the input port of the first valve to a patient. A second valve has an
input port connected to the second output port of the first valve. A dome
member has a first opening for connection with an input port of the second
valve, a second opening for receiving a pressure transducer and a third
opening to permit balancing of the system. Through this configuration, the
drainage collection bag is located before the pressure sensor, but at a
maximum distance from the patient to reduce the risk of infection and an
automatic relief valve may replace the second valve to provide for
automatic venting of dangerously high levels of intracranial fluids. U.S.
Pat. No. 4,869,457, dated Sep. 26, 1989, to G. Ewerlof, details an
"Arrangement For Controlling and Regulating a Liquid Flowing Through a
Line". The arrangement includes a valve body provided with a press-on or
deforming element movable along the line and designed to cooperate with
the line for regulating the flow of the liquid by means of restriction of
the liquid to varying degrees. In the line there is fitted a continuous
hollow element having a number of openings through which the liquid can
flow. The press-on element movable along the hollow element is designed to
press the line against the element. In this manner a shifting of the
press-on element can be carried out such that an optimal area of the
openings can be uncovered for through-flow of the liquid since that part
of the hollow element where the area is located is situated on the outlet
side with respect to the press-on element. The openings of the hollow
element can be uncovered to varying degrees by means of the press-on
element arranged in the valve body, the line being pressed against the
openings of the hollow element in such a manner that the flow is
restricted in varying degrees. An "Intravenous Administration System" is
detailed in U.S. Pat. No. 4,892,524, dated Jan. 9, 1990, to Gordon Smith.
The apparatus is designed to administer a volumetric flow of parenteral
liquids into a patient's system, through which the quantity of liquid
flowing into the system may be easily adjusted. The apparatus includes two
separate hydrostatic head pressure systems. The first head pressure is
applied from a container through a metering device with an adjustable
fixed orifice, to a regulator located a fixed distance below the
container. The second head is applied from the regulator, which is
designed to prevent air flow through it to the patient. U.S. Pat. No.
4,976,685, dated Dec. 11, 1990, to Frank E. Block, Jr., details a "Method
of Blood-Gas Interface Control in Surgical Gas Traps". The blood is stored
under refrigeration at a temperature of about 4 degrees Centigrade when it
is utilized on a relatively rapid basis within a surgical heater. It is
transported by tubing through a blood warming apparatus which, while
warming the blood, causes an out gas of entrained air. This air is trapped
in an air trap receptacle having a drip chamber, within which a gas-blood
interface is developed. To assure that the capacity of the trap is not
exceeded, an improved technique of gas removal and interface level setting
is provided, wherein access is achieved essentially through the entrance
region of the gas trap receptacle. U.S. Pat. No. 5,059,173, dated Oct. 22,
1991, to John J. Sacco, details an IV Apparatus. The IV apparatus includes
a gravity flow path fluid for administering IV fluids to a patient, in
which multiple IV fluids can be delivered at different flow rates to the
patient without having to replace the system apparatus. U.S. Pat. No.
5,074,334, dated Dec. 24, 1991, to T. Onodera, details a "Multi-Way Cock".
The multi-way cock includes a housing, including multiple branch tubes
extending from the periphery thereof, and a plug including a barrel
adapted to be rotatably fitted in the cylinder and having a corresponding
number of channels formed therein, the channels corresponding to the
branch tubes in assembled condition. U.S. Pat. No. 5,078,688, dated Jan.
7, 1992, to Richard Lobodzinski, details a "Paracentesis Catheter System".
The system is designed to remove fluid from the patient's abdominal cavity
and for administering medication into the abdominal cavity. The catheter
system includes a solid stylet, a catheter, a hemostasis valve assembly
connected to the catheter and delivery tubing with the needle connecting
the catheter assembly to a stopcock. The stopcock has provisions for
connection alternately to a syringe or to a vacuum bottle or drainage bag.
The hemostasis valve includes an internal gland which is compressed to
shutoff fluid flow through the end of the valve assembly after removing
the solid styler. This causes fluid to be diverted through the side arm
tubing and stopcock to a fluid collection container. U.S. Pat. No.
5,084,031, dated Jan. 28, 1992, to Robert J. Todd, et al, details a
"Cardioplegia Three-Way Double Stopcock". The stopcock includes a hollow
valve body with three solut | | |
