U.S. patent number RE31,873 [Application Number 06/444,710] was granted by the patent office on 1985-04-30 for venous catheter device.
Invention is credited to Randolph M. Howes.
United States Patent |
RE31,873 |
Howes |
April 30, 1985 |
**Please see images for:
( Reexamination Certificate ) ** |
Venous catheter device
Abstract
A venous catheter device including a plurality of independent
and noncommunicating fluid conveying lumens housed within or formed
in a single catheter. One end of each lumen is adapted to be
connected to a different fluid source, such as an intravenous (IV)
drug infusion or feeder device, a syringe, etc., or to a central
venous pressure (CVP) measuring device. The other end of each lumen
exits at or proximate to the catheter terminus which, in turn, is
adapted to be positioned within a vein. A hollow needle slidably
receives the catheter terminus and is adapted for vein penetration
and catheter positioning within the penetrated vein. Alternatively,
the catheter can be used without a needle in which case a vein is
directly exposed and partially transected allowing direct insertion
of the catheter.
Inventors: |
Howes; Randolph M. (Picayune,
MS) |
Family
ID: |
27034022 |
Appl.
No.: |
06/444,710 |
Filed: |
January 19, 1983 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
721215 |
Sep 8, 1976 |
04072146 |
Feb 7, 1978 |
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Current U.S.
Class: |
600/487; 604/43;
604/158 |
Current CPC
Class: |
A61M
25/0111 (20130101); A61B 5/02152 (20130101); A61M
2025/004 (20130101); A61M 2025/0034 (20130101); A61M
25/003 (20130101) |
Current International
Class: |
A61B
5/0215 (20060101); A61B 5/0215 (20060101); A61M
25/01 (20060101); A61M 25/01 (20060101); A61M
25/00 (20060101); A61M 25/00 (20060101); A61M
025/00 () |
Field of
Search: |
;604/21,43-45,158-163,280-283 ;128/658,674,692,742,748 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Cournand et al., Proc. Soc. Exper. Biol. Med., vol. 60: pp. 73-75
(1945). .
USCI Catalogue 1967-1968, p. 13. .
USCI Catalogue 1974, p. 3..
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Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Finnegan, Henderson, Farabow,
Garrett & Dunner
Claims
What is claimed is: .[.1. A venipuncture device including a hollow
needle having a generally circular cross-section, an elongated,
flexible catheter provided with a distal end portion generally
circular in cross-section and having a uniform outer diameter
slidably extending through said needle and capable of being fed
longitudinally into a vein, a plurality of fluid passages extending
longitudinally of said catheter and each having a terminus at the
distal end portion of said catheter and defining an opening to the
outside of said catheter, the terminus of each of said passages
being spaced from one another by a distance of at least about one
centimeter, said fluid passages being defined at least in part by
elongated flexible lumens extending from the proximate end of said
catheter, each of said lumens being adapted for attachment to a
separate fluid conveying device, whereby fluids may be separately
infused into the vein of a patient without becoming mixed before
infusion, and whereby blood samples may be withdrawn and venous
pressure measurements performed simultaneously with fluid
infusion..]. .[.2. A venipuncture device including a hollow needle
having a generally circular cross-section, an elongated, flexible
catheter provided with a distal end portion generally circular in
cross-section and having a uniform outer diameter slidably
extending through said needle and capable of being fed
longitudinally into a vein, said catheter including an elongated
tube and having a plurality of independent lumens extending
longitudinally thereof, one of said lumens terminating
substantially coextensive with the catheter tube terminus at the
distal end portion, the other of said lumens terminating at the
distal end portion of said catheter and defining an opening to the
outside of said catheter tube, each of said lumens having its
terminus spaced from each of the other lumen termini by a distance
of at least about one centimeter, each of said lumens having its
proximate end remote from said catheter distal end portion
extending beyond said catheter tube and fitted with a lumen
adapter, whereby each of said lumens may be connected to a fluid
flow device and may be simultaneously used to infuse fluid into the
vein of a patient, to withdraw blood samples from the patient's
vein and to take venous pressure measurements simultaneously with
said fluid infusion and blood sample withdrawal..]. .[.3. A
venipuncture device including a hollow needle having a generally
circular cross-section, an elongated, flexible catheter tube
provided with a distal end portion generally circular in
cross-section and having a uniform outer diameter slidably
extending through said needle and capable of being fed
longitudinally into a vein, a plurality of independent lumens
extending through said catheter tube, each of said lumens having a
terminus at the distal end portion of said catheter and defining an
opening to the outside of the catheter tube and being spaced from
each other, the proximate ends of the lumens remote from the
catheter distal terminus extending beyond said catheter tube and
being fitted with a lumen adapter for connection to independent
fluid devices, each of said lumen adapters being provided with
indicia to indicate a corresponding lumen to which the adapter is
connected and the position of each lumen terminus relative to the
terminus
of said catheter tube..]. .[.4. A venipuncture device including a
hollow elongated needle having a generally circular cross-section,
an elongated, flexibl catheter tube provided with a distal end
portion generally circular in cross-section and having a uniform
outer diameter slidably extending through said needle and capable
of being fed longitudinally into a vein, a plurality of elongated,
flexible lumens encased within said catheter tube and each having a
distal terminus adjacent the distal end portion of said catheter,
and a proximate end extending beyond the proximate end of said
catheter, the distal terminus of one of said lumens being
substantially coextensive with the distal terminus of the catheter
tube and the distal termini of the other lumens each extending
through a separate side opening in said catheter tube, all of said
lumen termini being spaced from each of the other lumen termini by
a distance of at least about one centimeter, a connector molded
over the proximate end of said catheter tube and encasing a portion
of the individual lumens extending beyond the proximate end of the
catheter tube, each of said lumens having a lumen adapter fitted on
its proximate end, whereby to facilitate connection of the
individual lumens to separate fluid devices, said adapters being
formed to receive flexible conduits and flow control
valves for controlling flow of fluid in the individual lumens..].
.[.5. A venous catheter device including an elongated, integral
flexible catheter tube provided with a distal end portion generally
circular in cross-section and having a uniform outer diameter
constructed for insertion into and capable of being fed
longitudinally of a vein, a plurality of independent lumens
extending through said catheter tube, each of said lumens having a
distal terminus adjacent the distal terminus of the catheter tube
and defining an opening to the outside of said catheter tube, the
distal terminus of said lumens being spaced from each other and all
of said lumen termini being within no more than about twelve
centimeters from the distal terminus of the catheter tube, the
proximate ends of the lumens extending beyond the proximate end of
said catheter tube and being fitted with a lumen adapter for
connection to independent fluid devices..]. .[.6. A venous catheter
device including an elongated, flexible catheter provided with a
distal end portion generally circular in cross-section and having a
uniform outer diameter constructed for insertion into and capable
of being fed longitudinally of a vein, a plurality of fluid
passages extending longitudinally of said catheter and each having
a terimus at the distal end portion of said catheter and defining
an opening to the outside of said catheter, the terminus of each of
said passages being spaced from one another by a distance of at
least about one centimeter, said fluid passages being defined at
least in part by elongated flexible lumens extending from the
proximate end of said catheter, remote from said terminus, at least
one of said passages providing means for infusing fluids into the
blood stream, and each of said lumens being adapted for attachment
to a separate fluid conveying device, whereby fluids may be
separately infused into the vein of a patient without becoming
mixed before infusion, and whereby blood samples may be withdrawn
and venous pressure measurements performed simultaneously
with fluid infusion..]. 7. A venous catheter device including an
elongated, flexible catheter tube provided with a distal end
portion generally circular in cross-section and having a uniform
outer diameter constructed for insertion into and capable of being
fed longitudinally of a vein, a plurality of independent lumens
extending freely through said catheter tube, each of said lumens
having a distal terminus adjacent the distal terminus of the
catheter tube and spaced from each other, one of said lumens having
its distal end substantially coextensive with the distal end of
said tube, the other of said lumens exiting at lateral openings in
said tube and being joined thereto, at least one of said lumens
providing means for infusing fluids into the blood stream, the
proximate ends of the lumens extending beyond the proximate end of
said catheter tube and being fitted with a lumen adapter for
connection to independent fluid devices. .[.8. A venous catheter
device including an elongated, integral flexible catheter tube
provided with a distal end portion generally circular in
cross-section and having a uniform outer diameter constructed for
insertion into and capable of being fed longitudinally of a vein, a
plurality of lumens formed as passages in said tube and extending
through said catheter tube, each of said lumens having a distal
terminus at the distal end portion of the catheter tube and
defining an opening to the outside of said catheter tube and being
spaced from each other, the proximate ends of the lumens extending
beyond the proximate end of said catheter tube and being fitted
with a lumen adapter for connection to independent fluid devices,
at least one of said lumens providing means for infusing fluids
into the blood stream..]. .[.9. A venipuncture device including a
hollow needle having a generally circular cross-section, an
elongated, flexible catheter provided with a distal end portion
generally circular in cross-section and having a uniform outer
diameter slidably extended through said needle and capable of being
fed longitudinally into a vein, a plurality of fluid passages
extending longitudinally of said catheter and each having a
terminus at the distal end portion of said catheter and defining an
opening to the outside of said catheter, the terminus of each of
said passages being spaced from one another by a distance of at
least about one centimeter, each of said passages being adapted for
attachment to a separate fluid conveying device, whereby fluids may
be separately infused into the vein of a patient without becoming
mixed before infusion, and whereby blood samples may be withdrawn
and venous pressure measurements performed simultaneously with
fluid infusion..]. .[.10. A venous catheter device including an
elongated flexible catheter provided with a distal end portion
generally circular in cross-section and having a uniform outer
diameter constructed for insertion into or capable of being fed
longitudinally into a vein, a plurality of fluid passages extending
longitudinally of said catheter and defining an opening to the
outside of said catheter, the terminus of each of said passages
being spaced from one another by a disance of at least about one
centimeter, each of the passages providing means for selectively
infusing fluids into the blood stream, withdrawing blood samples,
and measuring venous pressure, each of said passages being adapted
for attachment to a separate fluid conveying device, whereby fluids
may be separately infused into a vein of a patient without becoming
mixed before infusion, and whereby blood samples may be withdrawn
and venous pressure
measurements performed simultaneously with fluid infusion..].
.Iadd.11. A venous catheter device including an elongated, flexible
catheter tube provided with a distal end portion generally circular
in cross-section and having a uniform outer diameter constructed
for insertion into and capable of being fed longitudinally of a
vein, a plurality of independent lumens extending freely through
said catheter tube, each of said lumens having a distal terminus
adjacent the distal terminus of the catheter tube and spaced from
each other, one of said lumens having its distal end substantially
coextensive with the distal end of said tube, the others of said
lumens exiting at lateral openings in said tube and being joined
thereto, at least two of said lumens providing means for infusing
fluids into the blood stream, the proximate ends of the lumens
extending beyond the proximate end of said catheter tube and being
fitted with a lumen adapter for connection to independent fluid
devices. .Iaddend. .Iadd.12. A venous catheter device including an
elongated, flexible catheter tube provided with a distal end
portion generally circular in cross-section and having a uniform
outer diameter constructed for insertion into and capable of being
fed longitudinally of a vein, a plurality of independent lumens
extending freely through said catheter tube, each of said lumens
having a distal terminus adjacent the distal terminus of the
catheter tube and spaced from each other, one of said lumens having
its distal end substantially coextensive with the distal end of
said tube, the others of said lumens exiting at lateral openings in
said tube and being joined thereto, a first of said lateral
openings being spaced about one to three centimeters from the
distal end of said catheter tube and a second of said lateral
openings being spaced about one to three centimeters from said
first lateral opening, at least one of said lumens providing means
for infusing fluids into the blood stream, the proximate ends of
the lumens extending beyond the proximate end of said catheter tube
and being fitted with a lumen adapter for connection to independent
fluid devices. .Iaddend. .Iadd.13. A venous catheter device
including an elongated, flexible catheter tube provided with a
distal end portion generally circular in cross-section and having a
uniform outer diameter constructed for insertion into and capable
of being fed longitudinally of a vein, a plurality of independent
lumens extending freely through said catheter tube, each of said
lumens having a distal terminus adjacent the distal terminus of the
catheter tube and spaced from each other, one of said lumens having
its distal end substantially coextensive with the distal end of
said tube, the others of said lumens exiting at two lateral
openings in said tube and being joined thereto, said lateral
openings being spaced apart from one another by about one to three
centimeters, at least one of said lumens providing means for
infusing fluids into the blood stream, the proximate ends of the
lumens extending beyond the proximate end of said catheter tube and
being fitted with a lumen adapter for connection to independent
fluid devices. .Iaddend. .Iadd.14. A venous catheter device
including an elongated, flexible catheter tube provided with a
distal end portion generally circular in cross-section and having a
uniform outer diameter constructed for insertion into and capable
of being fed longitudinally of a vein, a plurality of independent
lumens extending freely through said catheter tube, each of said
lumens having a distal terminus adjacent the distal terminus of the
catheter tube and spaced from each other, one of said lumens having
its distal end substantially coextensive with the distal end of
said tube, the others of said lumens exiting at lateral openings in
said tube and being joined thereto, a first of said lateral
openings being spaced about one to three centimeters from the
distal end of said catheter tube, at least one of said lumens
providing means for infusing fluids into the blood stream, the
proximate ends of the lumens extending beyond the proximate end of
said catheter tube and being fitted with a lumen adapter for
connection to independent fluid devices. .Iaddend.
Description
This invention relates to venous catheter devices, more
particularly, this invention relates to a single catheter device
that may be used to infuse multiple fluids, including nourishment
and drugs, crystalloids, colloids, and blood and/or blood products,
simultaneously into a patient's vein. In addition, the catheter of
the present invention may be used for central venous pressure (CVP)
monitoring and/or removal of blood samples simultaneously with drug
and/or fluid infusion.
Conventional venous catheter devices utilize a single lumen, and
each is used singly to achieve one of the following: administer one
drug or IV feeding; monitor central venous pressure (CVP); or
withdrawing blood samples. Only one drug or IV fluid can be
administered through a single lumen catheter since it is
undesirable and contraindicated to mix many of these drugs and IV
fluids prior to their entering the bloodstream. Furthermore, CVP
monitoring and withdrawal of a blood sample cannot be performed
simultaneously with drug or fluid infusion using a single lumen
catheter. Also, a single lumen catheter should not be used to
alternately administer different drugs and fluids, monitor CVP, and
take blood samples, because of the mixing problems described above,
and because the catheter can clot and become inoperative.
Many patients, especially those in intensive care units, require
simultaneous drug administration, IV feeding, CVP monitoring, and
periodic blood sampling. In the past, this has meant that such
patients require insertion of a corresponding number of catheter
devices simultaneously coupled to major veins such as the external
or internal jugular, subclavian, cephalic, femoral or saphenous
veins. Obviously, this necessitates considerable patient risk and
is a source of great discomfort, possible bleeding, and possible
infection to a patient. Furthermore, since it is necessary to move
the location of these catheters periodically, e.g., every three or
four days, each location requires performing a new puncture (or
vein exposure and partial transection), patient discomfort and the
chance of infection or complication increases accordingly.
In an effort to minimize the discomfort, complication, and
infection problems described above, it has been proposed to use
catheters having multiple branched lumens merging in "Y" fashion in
a single lumen. In these devices, a single insertion can serve to
infuse several fluids into a patient's vein, withdraw blood
samples, and monitor vein pressure. However, of these prior art
patented devices, those suggesting simultaneous drug or fluid
administration suffer the above described drawback of drug and
fluid mixing prior to entering the bloodstream. In fact, some of
the prior art patents recognized this problem and tried to minimize
it by minimizing the length of the single lumen joining the
branches and the needle. While this may reduce the problem of drug
or fluid mixing before entering the bloodstream, it does not
eliminate it.
Furthermore, of these prior art patented devices, those
contemplating fluid infusion, blood sampling, and pressure
monitoring perform these functions alternately such that it is
necessary to seal off all but the one lumen in use. Thus, it is not
posible to have simultaneous infusion, CVP monitoring, and blood
sampling with these devices.
It is apparent, therefore, that a single venous catheter device
capable of simultaneously infusing several fluids, monitoring CVP,
and/or taking blood samples, and which overcomes the problem of
fluid mixing before entering the bloodstream, is highly
desirable.
Accordingly, it is a primary object of this invention to provide an
improved venous catheter device.
It is a further object of this invention to provide an improved
venous catheter device adapted to infuse a plurality of fluids into
a patient's vein simultaneously and without mixing the fluids,
medications, and/or blood products before entering the
bloodstream.
A further object of this invention is to provide an improved venous
catheter device which may be used to monitor venous pressure
simultaneously with fluid infusion, and which may be used to
withdraw blood samples from the patient's vein simultaneously with
either or both of the above.
Another object of the present invention is to provide an improved
venous catheter device which minimizes patient discomfort and
decreases the possibility of associated complications such as
infection and bleeding.
Still another object of this invention is to provide an improved
venous catheter device embodying multiple lumens adapted for
multiple and simultaneous operations as described, wherein means is
provided identifying individual lumens for preferred functions in
use.
Still another object of the present invention is to provide a new
multi-lumened venous catheter device wherein each lumen is provided
with an adapter facilitating ready connection to individual fluid
sources.
Other objects of the present invention are to provide an improved
venous catheter device which may be used together with a needle as
a venipuncture device, or apart from a needle in which case a vein
is exposed and partially transected and the catheter directly
inserted.
Still other objects of the present invention are to provide an
improved venous catheter device which is relatively inexpensive to
manufacture, readily sterilizable, sturdy in construction, and
reliable and efficient in use.
Additional objects and advantages of the present invention will
become more apparent from a consideration of the detailed
description which follows, and in part will be obvious from this
description or may be learned by practice of this invention. The
objects and advantages of this invention may be realized and
attained by means of the instrumentalities and combinations
particularly pointed out in the appended claims.
To achieve the foregoing objects and in accordance with the purpose
of the invention, as embodied and broadly described herein, the
venous catheter device of this invention comprises an elongated
flexible catheter having a plurality of independent and
non-communicating fluid conveying lumens extending therethrough,
said lumens having their terminii spaced from one another and
exiting from said catheter near its terminus, the other end of each
of said lumens being adapted for connection to a separate fluid
source such as an intravenous bottle or a syringe, or to a pressure
monitoring device, whereby a plurality of fluids may be infused
into a patient's vein, the patient's CVP may be monitored, and
blood samples can be withdrawn, all simultaneously or
selectively.
The venous catheter device of this invention can be used together
with a venipuncture needle in which case the needle is hollow and
slidably receives the terminus of the catheter. Alternatively, the
catheter device can be used apart from a needle wherein the
catheter is directly inserted into an exposed and partially
transected vein.
In addition, each lumen is provided with a lumen adapter, and the
lumens or the adapters may be appropriately marked or color coded
to suggest a preferred use for the individual lumens.
Furthermore, each lumen is constructed so that it can adapt to a
control valve and/or a flow plug so that each lumen may be
selectively and individually closed off when not in use, but may be
readily opened up when use is desired.
OF THE DRAWINGS
FIG. 1 is a view illustrating a three lumen catheter constructed in
accordance with a preferred form of the invention and shown with
the catheter in position in a vein and with a venipuncture needle
withdrawn and protected and showing the catheter connected to a
variety of fluid sources;
FIG. 2 is an enlarged view, partly in section, showing a
venipuncture needle in position in a vein and the catheter of this
invention about to be inserted through the needle into the
vein;
FIG. 3 is an enlarged view, partly in section, of a portion of FIG.
1 showing the catheter terminus and the multiple lumens;
FIG. 4 is an enlarged sectional view of FIG. 3 taken along the line
4--4 thereof;
FIG. 5 is a view similar to FIG. 3 but showing a modified form of
the invention; and
FIG. 6 is a sectional view of FIG. 5 taken along the line 6--6
thereof.
As used herein "lumen" is intended to mean fluid conduit means and
may include individual tubes, or elongated openings or passages
formed in a body, or it may include individual tubes connected to
elongated passages in a body.
Referring now to the drawings, a venous catheter device constructed
in accordance with the present invention is shown associated with a
hollow needle 11 supported at one end by a hollow needle hub 13 or
Luer Lok.sup.1 design for connection to a variety of syringe tips.
The other end of the needle 11 is formed with a sharpened and
tapered tip 15 for penetrating the skin 12 and a vein 14 of a
patient.
In accordance with the invention, an elongated flexible catheter 17
is provided and is adapted to extend through an opening 20 in the
hub 13 and through the hollow needle 11, and beyond the needle tip
15 when positioned in a vein. The catheter 17 is slightly smaller
in outer diameter than the inner diameter of the needle 11 so as to
slidably fit through the needle.
In accordance with a preferred form of the invention, the catheter
17 includes an outer tube 18 with a plurality of lumens positioned
therein and extending longitudinally therethrough. The lumens,
being illustrated as three in number and identified as 19, 21, 23,
are totally independent from and not communicative with one
another, and each extends to a point proximate the terminus 16 of
the catheter tube 18. As shown, lumen 19 terminates substantially
coextensive with the catheter terminus 16. Lumens 21, 23 terminate
at openings 25, 27 in the side of catheter tube 18 at points
axially spaced from one another and from the terminus of lumen 19.
Preferably, the terminus of lumens 19, 21, 23 are spaced at least
about one centimeter apart longitudinally of the catheter tube 18,
although this distance could be as much as three centimeters or
more. The lumens 19, 21, 23 and tube 18 are formed of a suitable,
flexible, heat sterilizable material such as is used in single
lumen catheters, and the lumens 21, 23 preferably are joined to the
tube 18 at openings 25, 27 using an adhesive, or by fusing.
In accordance with this preferred form of the invention, the
proximate ends of lumens 19, 21, 23 extend beyond the proximate end
of the catheter tube 18, and each is provided with an adapter 29,
31, 33, respectively, for attachment to a suitable device or fluid
source. Adapter 29 is shown receiving one leg 32 of a flow control
valve 35 which may, in turn, have another leg 37 receiving a
fitting 34 fixed to one end of a conduit 36 for a central venous
pressure (CVP) measuring device 39. Still another leg 38 of valve
35 may be connected to another fluid source or device (not shown)
which may be alternately communicated with leg 32 and lumen 19. As
shown, leg 38 is closed off by a cap 40. A control lever 42 of
valve 35 is turnable to open and close communicaion between the
valve legs 37, 38 and valve leg 32. In the position shown, the
valve legs 32, 37 are communicated and CVP device 39 is
operative.
Adapter 31 is shown receiving one leg 41 of stopcock valve 43.
Another leg 45 of valve 43 receives a fitting 46 fixed to conduit
47 connected to an IV bottle 49. A third leg 51 of valve 43 is
shown closed off by a cap 53. A control knob 55 on valve 43
selectively communicates leg 41 with leg 45 or leg 51, or both. In
the position shown, legs 41, 45 are communicated so that fluid from
IV bottle is flowing into lumen 21.
Finally, adapter 33 has a flow plug 57 fitted therein to seal off
lumen 23. However, this plug can be removed and adapter 33 fitted
with a syringe 59 for infusing drugs or taking blood samples.
In accordance with the invention, lumens 19, 21, 23 are totally
independent of and non-communicative with one another so that
fluids carried thereby will not mix prior to entering the
bloodstream. In addition, and as described, lumens 19, 21, 23 can
be used simultaneously for CVP monitoring, fluid infusion, and drug
injection and blood sampling. To achieve this, the terminus of each
lumen, namely the terminus 16 of catheter tube 18, and openings 25,
27 in the catheter tube 18, are axially spaced from each other by a
distance of at least about one centimeter and up to about three
centimeters or more. Thus, when the catheter 17 is so positioned in
a vein, two or more fluids can be infused simultaneously into the
bloodstream using any of the lumens 19, 21, 23 without mixing prior
to entry. The spacing of at least one centimeter between lumen
terminii is sufficient to prevent any mixing problem.
Furthermore, this individually of the lumens allows a patient's CVP
to be monitored, and, if desired, blood samples to be taken, at the
same time fluids are being administered, and all of this is
achieved with one vein puncture if a needle 11 is used, or one vein
exposure and partial transection if a needle 11 is not used. Prior
to the present invention, it was necessary to make one puncture (or
partial transection) for each fluid infusion, pressure measurement,
and blood sampling procedure to be performed on a patient
simultaneously. Thus, where several, e.g., three or more punctures
(or partial transections) were required previously, only one is
required with the present invention. This results in a considerable
reduction in risk and discomfort to the patient and obviously
reduces the likelihood of subsequent infection and
complication.
These advantages are, of course, amplified by the fact that venous
catheters must be moved periodically, for example, every three or
four days. Thus, while several new punctures (or partial
transections) were previously required approximately every three or
four days, now only one is required. The reduction in risk and
discomfort to a patient, and the reduction in the likelihood of
subsequent complication, infection or inflammation caused by these
punctures is immeasurable.
In accordance with another feature of this invention, the several
lumen adapters 29, 31, 33 may be color coded or otherwise
identified to suggest particular usage for the lumens associated
therewith. For example, CVP measurement will best be provided using
lumen 19 which exits centrally of the catheter tube 18 since that
lumen cannot contact the vein wall which otherwise might distort
pressure readings obtained. Lumen 23 is best adapted for withdrawal
of blood samples from a patient's vein since its terminus 27 is
furthest upstream in the direction of blood flow. Thus, any drugs
or IV feedings delivered through lumens 19 or 21 will be downstream
of terminus 27 and the sample of blood withdrawn through terminus
27 and lumen 23 is pure. Of course, it will be understood that all
lumens 19, 21, and 23 are available for IV or medicinal injections,
and that any of the lumens can be used for CVP monitoring. The
coding of adapters 29, 31, 33 can be any suitable means, such as
coloring, letters or numbers, and the instructions accompanying the
catheter can inform the catheter user of the intended and
recommended usage thereof.
The preferred embodiment illustrated and described herein is shown
with three lumens encased within a single catheter tube. It is
clear that the number of lumens may be varied, and it should be
understood that the inventive concept herein resides in the use of
a plurality of fluid conveying lumens disposed in a single
catheter, the lumens being separate and independent from one
another and non-communicative, and that the terminus of the lumens
are adjacent to the catheter terminus but are axially spaced from
one another. The lumens shown and described are encased in a
separate catheter tube and each lumen has its terminus suitably
joined or fused to the respective terminus openings adjacent the
catheter tube end.
It will be understood that a number of manufacturing techniques can
be employed to form this catheter-lumen assembly, and that
arrangements other than that shown herein can be employed, it being
understood that the catheter-lumen assembly be constructed
preferably from a suitable heat sterilizable material. For example,
the catheter and lumens can be integrally formed such that the
lumens are elongated openings through the catheter body itself,
rather than the lumens being separate tubes confined within a
separate catheter sheath. Such an arrangement is shown in FIGS. 5
and 6, the catheter being depicted as having an outer sheath 71 and
an inner walled portion 73 dividing the catheter into separate
lumens 75, 77, 79 extending therethrough. The sheath 71 and walled
portion 73 can be integrally formed, or separately formed and
suitably joined. In this embodiment, lumen 75 extends to the
catheter terminus, while lumens 77, 79 exit through openings 81, 83
each spaced at least one centimeter from the terminus and from each
other. The lumens 77, 74 forwardly of openings 81, 83 are shown
blocked by plugs 85, 87, respectively.
In the embodiment of FIGS. 5 and 6, separate lumens 89, 91, 93 have
their distal ends positioned in and suitably fixed to lumens 75,
77, 79, respectively, and have their proximate ends extending from
the catheter body. This is similar to the embodiment of FIGS. 1-3
where the proximate ends of lumens 19, 21, 23 also extend from
catheter body 17. In both embodiments, proximate ends of the lumens
desirably are provided with the separate catheter adapters as
shown. Preferably, the lumens are suitably joined in both
embodiments by a Y-connector 61, as shown, at the area where they
emerge from the catheter tube 18 (or 71) for convenience in
handling and for strength. This Y-connector can be suitably molded
using known techniques, and serves to prevent the lumens from being
pulled apart in use.
Furthermore, it will be understood that one or more of the lumens
can be closed off during use of the catheter by using a flow
control plug 57 or one of the valves 35, 43 described above.
However, should it become necessary to use a closed-off lumen, it
is a simple matter to remove this flow control plug 57 or open the
valve 35, 43 and then attach a suitable fluid device (IV bottle,
syringe, etc.) while the catheter is in place within a patient's
vein. Conversely, with the catheter in place, any one or more of
the lumens can be closed off by reversing the above procedure.
The manner of using the venous catheter of the present invention is
substantially the same as a single lumen venous catheter. Thus, if
the venous catheter is used with needle 11, the catheter tube 18 is
initially withdrawn within the needle 11. A venipuncture is then
made using the needle 11 to position the end 15 of the needle 11 in
place within a patient's vein. Thereafter, the catheter 17 is slid
longitudinally through the needle 11 so as to extend beyond the
needle tip 15 and into the punctured vein. While holding the
catheter tube 18, the needle 11 is withdrawn from the vein. A
needle guard 63 constructed of a flexible plastic, heat
sterilizable material frictionally grips the needle 11 and is slid
along the needle 11 and positioned over the needle tip 15 to
prevent it from severing the catheter tube 18. The assembly is then
suitably attached, as by tape or suture, to the patient adjacent to
the puncture in the usual fashion. The catheter is then in place
and the desired lumens are ready for attachment to suitable fluid
conveying devices, CVP measuring devices, etc.
Alternatively, a venipuncture can be made using needle 11 and a
connected syringe 95 (FIG. 2) and with the catheter 17 completely
withdrawn from the needle 11. With the needle 11 held in position
in vein 14, the syringe 95 is detached and the catheter 17 fed
through needle hub 13 and needle 11 into vein 14. Holding catheter,
needle 11 is then withdrawn, guard 63 is slid into position over
needle tip 15, and the assembly attached to the patient as
described above.
When used without a needle, a venous "cut-down" is first made in
which the desired vein (either the saphenous, cephalic, anticubital
and/or the external jugular) is directly exposed and partially
transected. The catheter is then directly inserted into the vein
without using a needle and is attached by tape or suture.
The present invention provides a venous catheter device that is
usable for infusion of more than one fluid simultaneously into the
vein of a patient. Also, blood samples may be withdrawn and CVP
measurements may be taken simultaneously with fluid infusion, and
with but a single puncture of the patient's vein.
It will be apparent to those skilled in the art that various
additions, modificaions, substitutions and omissions may be made in
the catheter of the present invention without departing from the
scope or spirit of the invention.
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