Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2003-02-25
2004-08-24
Thanh, LoAn H. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S027000, C604S246000, C604S173000, C604S523000
Reexamination Certificate
active
06780167
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a multi-lumen intravenous extension for transmitting liquids to a position adjacent a body and for mixing the fluids as close as possible to the point where they are injected into the blood stream of the body. For such a purpose, the multi-lumen intravenous extension of the present invention includes at least two, and possibly up to five, lumens, namely a main lumen for a carrier fluid, such as a saline solution, and at least one, and up to four, satellite lumens for carrying medication(s) to the body and mixing the medication(s) as close as possible to the point of input into the blood stream of the body at a proximal end of an intravenous catheter.
2. Description of the Prior Art
Heretofore catheters have been proposed for mixing components in the catheter prior to delivery of the mixture to a human body. Examples of analogous and non-analogous catheters are disclosed in the following analogous and non-analogous U.S. patents:
U.S. Pat. No.
Patentee
4,585,435
Vaillancourt
4,908,018
Thomsen
4,968,307
Dake et al.
5,041,083
Tsuchida et al.
5,190,525
Oswald et al.
5,279,587
Weenig
5,364,377
O'Neil
5,833,652
Pressman et al.
6,030,371
Pursley
Thomsen and the Oswald et al. both disclose manifolds for injecting drugs, medications or liquids into an intravenous catheter or conduit.
Dake et al. disclose a catheter having a central lumen for receiving a guide wire and four satellite lumens that extend coaxially with the central lumen. The outer periphery of the catheter has openings that communicate, respectively, with the four different satellite lumens for enabling four different fluids to be introduced into the vessel in which the catheter is inserted.
Pressman et al. disclose a component mixing catheter including an inner tubular body having a central lumen for a main fluid and an outer tubular body with an annular space between the inner tubular body and the outer tubular body for receiving a second liquid and the wall of the inner tubular body having holes therethrough for introducing the second liquid from the annular space into the main lumen where the second liquid is combined with the main fluid.
Vaillancourt shows, in
FIG. 8
, a septated or partitioned internal lumen where a micro-bore lumen and septal wall
51
are co-extruded within the internal diameter or circumference of the outer tube
52
such that both the diameter of the micro-bore lumen and septal wall extend inward and protrude into the circumference defining the lumen of the outer tube
52
. In other words, the intraluminal position of the micro-bore lumen and septal wall
51
reduces the cross-sectional area of the fluid conveying lumen of the outer tube
52
. This intraluminal configuration is consistent with the other embodiments of the Vaillancourt patent because Vaillancourt describes that the satellite tubes and lumen are contained within the lumen of the outer tube
52
. In Vaillancourt, all disclosed embodiments reduce the cross-sectional area of the outer tube
52
.
Weenig discloses a self-clearing extension set for delivery of fluid to a patient.
FIG. 2
of Weenig discloses a dual lumen extension tube
90
that is virtually identical to
FIG. 8
of Vaillancourt. Just like in Vaillancourt, Weenig discloses a small lumen
156
and separating membrane
158
extending inward and protruding into the circumference defining the large lumen
154
. In other words, the intraluminal position of the small lumen
156
and wall
158
reduces the cross-sectional area of the fluid conveying large lumen
154
.
Flow in a tube is described by the Hagen-Poiseuille Law, which provides that flow is linearly proportional to pressure of the fluid in the tube, viscosity of the fluid, and length of the tube, but is exponentially proportional to the radius of the tube. See Engineering Applications of Fluid Mechanics, J. C. Hunsaker and B. G. Rightmire, McGraw-Hill Book Company, Inc., 1947, indicating the principles of the Hagen-Poiseuille Law. Specifically, the Hagen-Poiseuille Law is described by the formula:
Q
=
π
r
4
(
P
1
-
P
2
)
8
μ
L
where:
Q is flow rate through a tube;
r is the radius of the tube;
&mgr; is the viscosity of the fluid;
L is the length of the tube; and
P is the pressure of the fluid.
Therefore, for a small decrease in the radius of the tube, a substantial reduction in flow ensues.
For the tubular embodiments described in Vaillancourt, i.e., for an inner tube
51
having an interior diameter of 0.020 inches, the micro-bore tube
51
occupies a significant amount of space and flow rate through Vaillancourt's outer tube
51
is affected to a substantial degree when viewed in terms of delivering a medication to a patient. Contrast Vaillancourt at col. 6, lines 56 to 60. Specifically, the embodiment shown in
FIG. 8
of Vaillancourt, which is partially within the wall of outer tube
52
, decreases flow in outer tube
52
by at least 18 percent. If a tube such as inner tube
51
is inserted entirely within outer tube
52
as illustrated in
FIGS. 6
,
7
,
9
, and
10
of Vaillancourt, then flow is decreased by at least 28 percent. If the embodiment of Vaillancourt was changed to place two inner tubes
51
within outer tube
52
, then flow in outer tube
52
is decreased by at least 54 percent.
Similarly, for the tubular embodiment described in Weenig, small lumen
156
occupies a significant amount of space and flow rate through Weenig's large lumen
145
and is affected to a substantial degree when viewed in terms of delivering a medication to a patient.
Specifically, the embodiment shown in
FIG. 2
of Weenig, having the small lumen
156
partially within the large lumen
154
, decreases flow in large lumen
154
by approximately 15 to 20 percent.
Such a decrease in flow within the Vaillancourt outer tube
52
or the Weenig large lumen
154
is entirely undesirable. The purpose of fluid conveyed in the lumen of outer tube
52
is for patient fluid maintenance and volume fluid bolus, both of which may require delivering a large volume of fluid in a short period of time. Compromising the ability to rapidly convey a large volume of fluid could have detrimental effects on the patient.
O'Neil discloses three or four entirely separate lumens that are each glued/fastened into a common connector
42
. See O'Neil at
FIGS. 6 and 8
. In each multi-lumen embodiment, the largest lumen
4
is compressed and, therefore, obstructed.
Tsuchida discloses a multi-lumen catheter. This catheter is shown in
FIG. 1
b
. As set forth therein, each of the lumen are triangular in shape.
Finally, Pursley discloses a system for manufacturing catheters. However, Pursley is expressly distinguished from extrusion processes.
SUMMARY OF THE INVENTION
It is accordingly an object of the invention to provide a multi-lumen intravenous extension and method for conveying medicinal fluids that overcome the hereinafore-mentioned disadvantages of the heretofore-known devices and methods of this general type and that are configured to integrate with existing standardized infusion systems. The multi-lumen intravenous extension is positioned between an intra-vascular or intravenous access site and an infusion system typically including a supply of saline and syringes for injecting drugs, medications or other liquids into the multi-lumen intravenous extension. The multi-lumen intravenous extension allows for organized and efficient delivery and administration of a wide variety of medications and pharmaceutical agents, using less priming volume, minimizing effects of carrier fluid rates, and requiring only a minimal amount of medication mixing.
With the foregoing and other objects in view, in a drug delivery system having a medicinal fluid supply system with at least two supplies independently supplying at least two medicinal fluids at a distal connector, there is provided, in accordance with the invention, an extension including a mixing connector defining a mixing chamber to be flu
Greenberg Laurence A.
Mayback Gregory L.
Maynard Jennifer
Stemer Werner H.
Thanh LoAn H.
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