U.S. patent number 3,682,159 [Application Number 05/026,006] was granted by the patent office on 1972-08-08 for catheter electrode for oxygen polarography.
This patent grant is currently assigned to United States Catheter & Instrument Corporation. Invention is credited to Denis S. Imredy, Fred P. Schleipman.
United States Patent |
3,682,159 |
Imredy , et al. |
* August 8, 1972 |
CATHETER ELECTRODE FOR OXYGEN POLAROGRAPHY
Abstract
A minature electrode comprising cathode, anode, electrolyte and
oxygen-permeable diaphragm, with a shell and housing adapted for
secure attachment to the end of a catheter, to be introduced into
positions where in vivo oxygen tension determinations can be made
in blood or other body fluids.
Inventors: |
Imredy; Denis S. (Lyme, NH),
Schleipman; Fred P. (Norwich, VT) |
Assignee: |
United States Catheter &
Instrument Corporation (Glens Falls, NY)
|
[*] Notice: |
The portion of the term of this patent
subsequent to September 15, 1987 has been disclaimed. |
Family
ID: |
21829306 |
Appl.
No.: |
05/026,006 |
Filed: |
April 6, 1970 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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525926 |
Feb 8, 1966 |
3528403 |
|
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Current U.S.
Class: |
600/360;
204/415 |
Current CPC
Class: |
A61B
5/14542 (20130101); A61B 5/1473 (20130101); G01N
27/404 (20130101) |
Current International
Class: |
A61B
5/00 (20060101); G01N 27/49 (20060101); A61b
005/00 () |
Field of
Search: |
;128/2R,2.5D,2.5F,2.5R,2.1E,2.1R ;204/195B,195L,195M,195P,195R |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Kamm; William E.
Parent Case Text
This application is a continuation-in-part of application Ser. No.
525,926, filed Feb. 8, 1966 now U.S. Pat. No. 3,528,403.
Claims
What is claimed is:
1. An electrode assembly for use in oxygen polarography comprising
an elongated tubular insulating plastic shell, a gas-permeable
plastic membrane closing the distal end of said shell, an elongated
tubular metal housing screw-threaded adjacent its distal end, said
shell being correspondingly screw-threaded from its proximal end
and said tubular housing being screwed into said shell to a point
approximately midway between the ends of said shell, the proximal
end of said shell being at a point approximately midway between the
ends of said tubular housing, whereby approximately half of said
tubular housing projects proximally from said shell, a cylindrical
insulating electrode base having a larger portion fitting and
secured in the bore of said tubular housing and a cylindrical stem
integral with said larger portion and projecting distally
therefrom, a first passage extending axially of said base and stem,
a second passage extending axially of said larger portion, a
cathode mounted at the distal end of said stem and having a lead
extending through said first passage, an anode projecting distally
from said larger portion adjacent to said stem and having a lead
extending through said second passage, and a quantity of
electrolyte confined within a space bounded by said shell, said
membrane and the distal ends of said base and said tubular housing,
the proximally extending portion of said tubular housing being
adapted to fit within and be secured to a substantial distal
portion of a catheter.
2. An electrode according to claim 1, wherein the screw-threaded
portion of the housing is bounded proximally by an integral
unthreaded flange.
3. An electrode according to claim 1, wherein the screw-threaded
portion of the housing is traversed axially by at least one
groove.
4. An electrode according to claim 1, wherein the screw-threaded
portion of the housing is bounded proximally by an integral flange
and an integral shoulder spaced to define an annular recess.
5. An electrode according to claim 2, wherein the screw-threaded
portion of the housing and the flange are traversed axially by at
least one groove.
6. An electrode according to claim 4, wherein the screw-threaded
portion of the housing and the flange are traversed axially by at
least one groove.
7. An electrode according to claim 1, which includes an inner shell
fitted within the first named shell adjacent the distal end
thereof, the plastic membrane being held in place by engagement
between said shells.
8. An electrode according to claim 1, wherein the cathode is
entirely encapsulated by the said stem with only its distal end
surface exposed to electrolyte.
9. An electrode according to claim 1, wherein the anode is
flattened.
Description
It is broadly old to employ polarographic cells in the in vitro
determinations of oxygen tension in human blood and other
biological fluids. Such cells, or electrodes, generally consist of
a platinum cathode and a silver reference anode enclosed within a
unit containing an electrolyte bridge and covered at one end by a
gas-permeable plastic membrane. The unit is maintained at 0.6 volt
potential and the membrance, which is an insulator and is not
permeable to fluids, separates the specimen from the electrodes so
no current can flow into the specimen. When oxygen molecules
diffuse from the specimen through the membrane to the polarized
cathode surface, the cathode becomes depolarized allowing a current
to flow which is directly proportional both to the amount of oxygen
contacting the cathode and to the oxygen content of the specimen.
This current can be measured and read off or recorded by any
suitable indicating device such as a galvanometer.
However, the size, shape and construction of the electrode
described above prohibits or severely limits any practical
application to in vivo clinical use, in sharp contrast to the fact
that in addition to the indispensability of in vitro oxygen
polarography there is a steadily increasing demand for measuring
the oxygen tension directly and continuously in vivo.
Therefore, an object of this invention is to provide a miniaturized
electrode that will function satisfactorily and safely when
attached to or in a catheter for in vivo determinations of oxygen
tension in blood, lung gases and other biological fluids.
Another object of this invention is to provide an electrode of the
character stated in which the cathode and anode supporting element
and the capsule cover therefor are fabricated from an inert
insulating plastic, said supporting element including an inert
plastic tube and plug press fitted into an insulated stainless
steel housing provided with improved means for securely
interconnecting the parts and mounting the electrode on the
catheter.
A practical embodiment of the invention is shown in the
accompanying drawings, wherein:
FIG. 1 represents a longitudinal axial section of an electrode as
attached to a catheter, the electrical circuit being shown
diagrammatically;
FIG. 2 represents a sectional view on the line II -- II of FIG.
1;
FIG. 3 represents a sectional view on the line III -- III of FIG.
1;
FIG. 4 represents a detail longitudinal axial section of the outer
shell;
FIG. 5 represents a detail longitudinal axial section of the
catheter base; and
FIG. 6 represents a greatly enlarged detail sectional view on the
line VI -- VI of FIG. 5.
Referring to the drawings, the electrode is shown as comprising a
platinum cathode 1 and a silver anode 2 embedded in a one piece
plastic base 3 which in turn is press fitted into an insulated
stainless steel tubular housing tube 4. This tube has an extended
cylindrical proximal end portion 5 for the purpose of affixing the
tube 4 permanently to the tip of the catheter 12, and bears
external threads 6 for affixing the outside capsule 7. The threads
6 are tapered and have three equally spaced axially extending slots
8 (FIGS. 1, 3, 5, 6) serving as vents during assembly. A solid
flange 9 is located at the rearward end of the threads 6; this
flange 9 is slightly larger in diameter than the root of the
threads 6 and acts as a lock binding additionally the outside
capsule 7 to the stainless tube 4. Immediately adjacent to flange 9
is an annular recess 10 bounded rearwardly by a shoulder 11 located
approximately midway between the ends of the tube. The recess 10
permits the threaded portion 19 of outside capsule 7 to shrink into
recess 10 after passing over flange 9, tightening the grip of
outside capsule 7 onto steel tube 4. The shoulder 11 serves as a
stop for precise positioning of steel tube 4 with respect to the
end of catheter 12.
The plastic base 3 is made of a suitable plastic material having
good chemical resistance, electric insulating properties and
resistance to wetting, such as "Kel-F", a polymer of
trifluorochloroethylene marketed by 3-M. The larger cylindrical end
of base 3 is snugly fitted into tube 4. The stem end 3A of base 3
protrudes beyond the end of tube 4 and contains a longitudinal bore
13 extending the entire length of base 3 and being enlarged near
its end, as shown at 14, to receive the cathode 1. The larger end
of base 3 contains another longitudinal bore 15 in spaced parallel
relation to bore 13 to receive the extension 16 of anode 2, which
portion 16 is not part of the polarographic cell called electrode
area.
The cathode 1 is a short bar of platinum connected at its base by
soft solder to the end of a fine copper wire 17, preferably vinyl
acetal enameled, of the type sold as "Formvar" by Acme Wire Co.,
New Haven, Conn. The cathode 1 has its end squarely even and flush
with the end of the stem 3A of base 3.
The anode 2, constituted by a silver wire, is securely mounted with
its extension 16 in the second longitudinal bore 15 of base 3 and
protrudes freely alongside the stem 3A to a distance slightly less
than the length of said stem, the protruding part being flattened
as shown at 2A.
The parts just described are assembled with the tubular outside
capsule 7 which consists of an outer shell 18, a proximal portion
19 of which is internally threaded, an inner shell 20 equal only to
about one-fourth the length of outer shell 18, and a gas-permeable
plastic membrane 21. The membrane 21 is stretched over the end of
inner shell 20 and inserted, press-fitted and cemented into the
outer shell 18, lying flush with the end of same. The void between
outside capsule 18, base 3, distal end of tube 4, and membrane 21,
and not occupied by anode 2 and stem 3A, is filled with electrolyte
22, such as a half saturated KCl, that is, 18 grams of Potassium
Chloride per 100 ml. H.sub.2 O.
Before assembling, the outside capsule 7 should be filled, free of
air, with electrolyte 22 and screwed onto the threaded steel
housing tube 4 for establishing an electrolyte bridge between
cathode 1 and anode 2. The distal end of tube 4 extends to a point
approximately midway between the ends of shell 18. Since cathode 1,
anode 2, plastic base 3, and stainless steel tube 4 are permanently
assembled as a unit and screwed into outer capsule 7 as such, means
must be provided to permit the escape of excess electrolyte and
trapped air, if any, from the void mentioned above during the
screwing procedure. The means is shown in FIGS. 1, 3 and 6 as
comprising longitudinally extending grooves or slots 8 in the
threaded surface of the tube 4 from its forward end through the
lock flange 9, terminating in the recess 10; permitting excess
fluid to escape through the grooves eliminates any pressure within
the electrode area and insures the proper electro-chemical function
of the cell. Furthermore, when the outside capsule is fully seated,
with its proximal the shoulder 11 at a point midway between the
ends of the tube 4, in the position shown in FIG. 1, there is no
force tending to cause leakage and none takes place. This portion
of the electrode assembly is further sealed by snugly fitting the
forward end of catheter 12 over the rearwardly extending portion 5
of steel tube 4 and also against shoulder 11 and securing the
catheter 12 thereto by means of a suitable epoxy cement.
In use, the ends of the silver anode extension 16 and wire 17 are
extended to constitute, or are connected to, separate insulated
leads 23, 24, which extend through the lumen 25 of catheter 12 and
connect to a polarographic circuit indicated at 26 (which includes
a dry cell), the current in this circuit being monitored by a
recording galvanometer 27 or the like, connected to circuit 26 by
leads 28. The catheter 12 may have one or more lumens as indicated
for the areas or fluids where O.sub.2 determination is to be
effected.
The actual electrode, constructed as described above, has a
diameter of about 0.080 inch and length of about 0.450 inch, being
fitted on the end of a catheter having the same diameter (6 F.) and
of any suitable length. The instrument can be used to determine
O.sub.2 content and variations thereof within the heart, blood
vessels, brain, spinal fluid, lungs or any cavity or area of the
body that the electrode can reach.
The space 22 holds a substantial quantity of the electrolyte and
the flattened end 2A of the anode provides a relatively large
surface area in contact with the electrolyte, for stability and
durability. The layer of electrolyte between the cathode 1 and
membrane 21 is very thin so that it responds readily to variations
in the rate of penetration of O.sub.2 through the membrane, such
responses being immediately reflected in the current flow through
the polarographic circuit, as previously explained. Since the
electro-chemical aspects of oxygen polarography are well known,
they need not be further discussed.
* * * * *