U.S. patent number 3,659,588 [Application Number 05/026,697] was granted by the patent office on 1972-05-02 for catheter apparatus.
This patent grant is currently assigned to Medtronic, Inc.. Invention is credited to Alan R. Kahn, Florence A. Stroebel.
United States Patent |
3,659,588 |
Kahn , et al. |
May 2, 1972 |
CATHETER APPARATUS
Abstract
A catheter having walls of which at least a portion is
electrically conductive and has an electrical resistivity
approximately equal to the electrical resistivity of blood.
Inventors: |
Kahn; Alan R. (Morrestown,
NJ), Stroebel; Florence A. (Maple Shade, NJ) |
Assignee: |
Medtronic, Inc. (Minneapolis,
MN)
|
Family
ID: |
21833307 |
Appl.
No.: |
05/026,697 |
Filed: |
April 8, 1970 |
Current U.S.
Class: |
600/301; 174/47;
128/908; 138/118; 361/215; 600/433; 604/523 |
Current CPC
Class: |
A61N
1/056 (20130101); A61B 5/276 (20210101); A61M
25/00 (20130101); A61B 5/0215 (20130101); A61B
5/283 (20210101); A61M 25/0009 (20130101); A61M
25/005 (20130101); Y10S 128/908 (20130101) |
Current International
Class: |
A61B
5/042 (20060101); A61B 5/0408 (20060101); A61B
5/0215 (20060101); A61B 5/0424 (20060101); A61M
25/00 (20060101); A61N 1/05 (20060101); A61b
005/02 (); A61m 025/00 () |
Field of
Search: |
;128/2.5R,2.5D,2.6R,2.6E,2,348-351 ;138/118 ;317/2R |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
What is claimed is:
1. Catheter apparatus comprising tubular means having walls, at
least a portion of said walls being electrically conductive and
having an electrical resistivity of approximately from 12
ohm-centimeters to 1,200 ohm-centimeters.
2. The apparatus of claim 1 in which all of said walls are
electrically conductive and have an electrical resistivity of
approximately from 12 ohm-centimeters to 1,200 ohm-centimeters.
3. The apparatus of claim 1 in which the electrical resistivity of
said portion of said walls is approximately equal to the electrical
resistivity of blood.
4. The apparatus of claim 3 in which the electrical resistivity of
said portion of said walls is approximately from one-tenth to 10
times the electrical resistivity of blood.
5. The apparatus of claim 1 in which said portion of said walls
comprises a part of said walls adapted to be adjacent to the skin
of an animal during intracorporeal application of said catheter
apparatus.
6. The apparatus of claim 1 in which said portion of said walls is
electrically semiconductive.
7. Improved catheter apparatus comprising: tubular means defining a
lumen for the passage of fluids into an animal's body; and said
means being electrically semiconductive and having a substantially
uniform electrical resistivity selected in the range from
approximately 12 ohm-centimeters to 1,200 ohm-centimeters.
Description
BACKGROUND OF THE INVENTION
This invention is concerned with an improved catheter. Catheters
constructed as hollow tubes are well known in the art for their use
in the practice of medicine as well as in medical research.
Catheters are used, for example, to measure pressures in body
organs and in the circulatory system, to withdraw samples of body
fluids, and to introduce drugs, intravenous fluids, X-ray contrast
media, dyes for cardiac output measurements, and nasogastric
feeding.
In performing functions such as those mentioned above, the catheter
or tube is normally filled with solutions which are electrically
conductive. In many of these applications, one end of the catheter
terminates inside the body in close proximity to the heart while
the other end is attached to an electrical device or electronic
instrumentation. As the catheter is normally made of an
electrically insulating material, the solution within the catheter
acts as an isolated circuit for electrical current into the body,
and close proximity to the heart causes the possibility of
accidental death due to accidentally applied electrical power which
will be felt near the heart and may cause ventricular
fibrillation.
The above-mentioned danger is now well known to those skilled in
the art, and various studies are being conducted to overcome the
problem. The apparatus of the present invention does overcome the
problem by providing a catheter having a conductive wall so that
electrical current is disbursed through the blood and body tissues
rather than being concentrated at or near the heart.
SUMMARY OF THE INVENTION
Briefly described, the apparatus of this invention comprises a tube
having walls at least a portion of which is electrically conductive
or semiconductive material and has an electrical resistivity
sufficient to prevent harmful current flow to organs within the
body when the tube is used as a catheter for intracorporeal
applications.
IN THE DRAWINGS
FIG. 1a is a representation of the catheter apparatus of this
invention;
FIG. 1b is a representation of the apparatus of this invention as
it is in the process of being assembled;
FIG. 2 is a schematicized drawing representative of the current
density pattern in the body of a human being between a pair of skin
electrodes;
FIG. 3 is a schematicized drawing of the current density pattern
between a prior art intravascular catheter and a skin electrode;
and
FIG. 4 is a schematicized diagram of the current density pattern
between an intravascular catheter of this invention and a skin
electrode.
BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENT
It will be understood that the drawings are intended to be merely
representative of the general configuration of the parts they show
and are not drawn to scale, or to relative scale, in the interests
of clarity.
As used throughout this specification and the claims, "electrical
resistivity" means volume resistivity in ohm-centimeters, according
to the equation,
which equations is known to those skilled in the art.
Referring to FIG. 1a, it should be understood that the catheter
apparatus of this invention comprises a hollow tube or catheter 10
with electrically conductive or semiconductive walls 14 which have
electrical resistivity. The catheter apparatus must be durable and
preferably flexible. In FIG. 1b, there is shown in the stage of
construction a catheter of this invention 10 which is being made by
winding a base material 11, such as a Dacron mesh, around a rod 12,
preferably a stainless steel rod.
The apparatus of this invention has been made by first coating rod
12 with wax and then cutting a base material 11, such as Dacron or
nylon mesh, into 3-foot long strips, 1 centimeter wide. Mesh 11 is
then wound on rod 12 in a helical pattern with overlapping
windings. A solution is then applied to the base material 11 in
sufficient quantities to flow through the base material, the
solution being one which will harden into a durable, flexible,
electrically conductive or semiconductive coating when cured. The
solution is then cured, and when dry, further coatings are applied
and dried as necessary to form walls 14. A solution which has been
used in the preferred embodiment of the apparatus of this invention
is a flexible carbon impregnated elastomer, known as Eccocoat No.
258, which has a measured volume resistivity of about 133.5 ohm-cm.
This material was thinned out with a solvent and painted on the
base material 11, using enough solvent to cause the material to
flow through mesh 11. It was than dried in a 150.degree. F. oven
for 15 minutes. A second coat was then painted on using a thicker
solution of the material than in the previous step, and it was
again dried in the oven. Two further coats of the material were
added as in the latter step. The completed catheter was then
removed from rod 12. This catheter, comprising the apparatus of
this invention, was tested in a manner to be more fully described
below. Other materials which could be used to fabricate the
apparatus of this invention include carbon-filled polyethylene,
carbon-filled polyvinylchloride, carbon-filled rubber, and
carbon-filled silicones. Catheters can also be fabricated from such
materials alone without the need for the mesh base as described
previously.
To best understand the operation of the apparatus of this
invention, reference should be made to FIGS. 2, 3, and 4 of the
drawings.
As stated above, electrical shock hazards resulting from defective
medical electrical equipment are well known in the art. It is
common knowledge that 60 cycle alternating current greater than 100
milliamperes can be dangerous when flowing through the human body
between two points on the body surface. The heart tissue is most
susceptible to such current, and electrocution deaths are most
commonly the result of ventricular fibrillation of the heart.
Over the past decade, an increased awareness of the susceptibility
of the heart to 60 cycle alternating electrical currents has been
developed. When a current flows between two points on the surface
of the body, it is distributed more or less uniformly throughout
the tissues, and the density of current at any single point deep
inside the body is comparatively small. This may be seen by
reference to FIG. 2, where a body 15 has placed thereon a pair of
electrodes 16 and 17 between which is flowing a current indicated
by current density lines 20. A review of the current density lines
will indicate that when electrical current flows through the body
from two points on or near the body surface, the current becomes
distributed more or less uniformly in the body blood and tissues,
and the current density at any one point inside the body, such as
the heart, is relatively small.
The heart is highly sensitive to 60 cycle alternating current, and
currents as low as 10 to 20 microamperes can cause fibrillation
when injected over 1 square millimeter of heart muscle. However, to
generate 10 microamperes per square millimeter of current density
at the heart surface from electrical contact on either arm, such as
electrodes 16 and 17 on body 15 of FIG. 2, it is necessary to
provide a current flow of 100 milliamperes. This is because the
current is effectively disbursed through the volume of the blood
and tissues in the body.
However, when a catheter containing electrically conductive liquid
is introduced near the heart, the current density situation is
significantly altered. In FIG. 3, there is again shown body 15 and
electrode 16, but the current density lines 21 now indicate the
flow of current between electrode 16 and an intravascular catheter
18 here shown to be a prior art hollow catheter having a
nonconductive wall.
As can be seen in FIG. 3, catheter 18 terminates within the heart,
and because of the conductive effect of the solution or liquid
within catheter 18, virtually all of the current passing through
catheter 18 exits at a small area near the heart muscle. That is,
the current density at the end of the catheter is sufficiently
great so that as little as 20 microamperes of current can be
lethal. Such small currents can result from many accidental causes.
For example, if the catheter is connected to a grounded pressure
transducer or fluid injector, as is often the case, a small
electrical potential introduced at any point on the body can be
dangerous. As a specific example, a nurse who may adjust a properly
functioning bedlamp having an exposed metal part which is not
grounded can kill the patient by simply touching him.
It is, therefore, desirable that the walls of the catheter or at
least a portion thereof be of a conductive material so that
electrical currents impressed on the catheter may pass through the
catheter walls into the body and be disbursed to avoid density at
the heart. If the walls of the catheter are substantially better
electrical conductors than the surrounding blood and tissue, then
the electrical current will pass out uniformly into the blood and
tissue along the length of the catheter. However, if the catheter
walls are highly conductive along its length as well as through its
walls, it will provide a low impedance between the source of power
and the heart and be even more dangerous than the above-mentioned
prior art catheter because very low voltages can generate high
currents. Obviously then, a highly conductive catheter is even more
dangerous than a highly insulated catheter.
The catheter of the apparatus of this invention is selected to have
a conductive or semiconductive surface with an electrical
resistivity approximately in the range from 12 to 1,200
ohm-centimeters, preferably approximately equal to the electrical
resistivity of blood, 120 ohm-centimeters. That is, the catheter
apparatus of this invention has a wall with at least a portion
having an electrical resistivity of one-tenth to 10 times the
electrical resistivity of blood.
Referring now to FIG. 4, there is again shown the body 15 and
electrode 16 and a plurality of current density lines 22 flowing
between electrode 16 and an intravascular catheter 10 comprised of
the apparatus of this invention. In FIG. 4, it is apparent that the
current begins to disburse at the site at which catheter 10
penetrates the skin of body 15. Thus, the pattern of dispersion is
similar to that which would be present if the catheter 10 were not
used and the current were injected from a surface electrode such as
17 in FIG. 2. It has been proven by experimentation that greatly
increased currents can be applied without causing ventricular
fibrillation of the heart when the apparatus of this invention, as
shown in FIGS. 1a, 1b, and 4, is used in place of prior art
catheters.
From the above, and with reference to FIG. 4, it will be apparent
that catheter 10 need not be electrically conductive or
semiconductive along its entire length, but that it must include a
part of its wall which is conductive or semiconductive at the point
adapted to be in contact with the skin after intracorporeal
application of the improved catheter.
The improved catheter apparatus of this invention was built and
tested in a live, intact dog under conditions normally present in
human cardiac catheterization. Similar tests were performed on a
conventional catheter normally used in human diagnostic cardiac
studies, in this case a standard No. 7 Lehman cardiac catheter.
A catheter of the apparatus of this invention was passed to the
right ventricle of the heart through the femoral vein and wedged
between muscular trabeculations. The prior art catheter of
identical length and internal diameter was passed to the right
ventricle through another femoral vein and also wedged between
muscular trabeculations. Sixty cycle AC current was applied to the
catheter of this invention beginning with 6 microamperes and
increasing in 15 steps to 10,000 microamperes. Each current step
was applied for 5 seconds. Electrocardiogram and intraventricular
pressures were monitored continuously. No effect on the heart was
observed. At the 10,000 microamperes level, the animal's leg was
seen to twitch where the catheter entered the skin. Results of this
test are shown in Table I below.
---------------------------------------------------------------------------
TABLE I
Improved Catheter Apparatus
Current-ua Time applied-sec. Response
__________________________________________________________________________
6 5 none 12 5 none 23 5 none 55 5 none 105 5 none 175 5 none 240 5
none 325 5 none 530 5 none 740 5 none 1000 5 none 1450 5 none 2300
5 none 2950 5 none 6200 5 none 10,000 5 leg muscle twitch
__________________________________________________________________________
The prior art catheter was then tested in a similar manner.
However, when the current reached 70 microamperes, ventricular
fibrillation of the heart occurred. The dog was restored
immediately to normal sinus rhythm using DC cardioversion at 50
watt-seconds, in a manner known to those skilled in the art. It is
also interesting to note that at 50 microamperes the dog began to
have occasional ventricular premature beats. The results of this
test are shown in Table II below.
---------------------------------------------------------------------------
TABLE II
Prior Art Catheter
Current-ua Time applied-sec. Response
__________________________________________________________________________
6 5 none 12 5 none 17.5 5 none 22 5 none 34 5 none 50 5 Occ. VPB'S*
70 5 Ventricular fibrillation
__________________________________________________________________________
*(ventricular premature beats)
The prior art catheter was withdrawn to the vena cava, and the
catheter of this invention was repositioned in the right ventricle.
The above-described test was repeated, and again, no cardiac
disturbances were observed. Again, the 10,000 microamperes current
produced leg twitching. Reference is made to Table III for the
results of this test.
TABLE III
Improved Catheter Apparatus
Current-ua Time applied-sec. Response
__________________________________________________________________________
6 5 none 23 5 none 80 5 none 240 5 none 740 5 none 1450 5 none 3000
5 none 4500 5 none 6300 5 none 8000 5 none 10,000 5 leg muscle
twitch
__________________________________________________________________________
The catheter of this invention was then withdrawn to the vena cava,
and the prior art catheter was repositioned in the right ventricle.
The above test was again repeated, and again, the dog had
ventricular fibrillation of the heart at 70 microamperes of input
current. Cardioversion again restored normal sinus rhythm. The
results of this test are shown in Table IV.
TABLE IV
Prior Art Catheter
Current-ua Time applied-sec. Response
__________________________________________________________________________
6 5 none 12 5 none 17 5 none 22 5 none 34 5 none 50 5 70 5
Ventricular fibrillation
__________________________________________________________________________
The two sets of the last above two paragraphs were repeated in
sequence, with the same results. However, when using the prior art
catheter, the animal fibrillated at 50 microamperes but stopped
after the current was turned off. When 70 microamperes was again
reached, ventricular fibrillation occurred but was irreversible.
The results of these further tests can be seen in Tables V and VI
below.
TABLE V
Improved Catheter Apparatus
Current-ua Time applied-sec. Response
__________________________________________________________________________
12 5 none 80 5 none 530 5 none 740 5 none 1450 5 none 2950 5 none
6250 5 none 10,000 5 leg twitch
__________________________________________________________________________
---------------------------------------------------------------------------
TABLE VI
Prior Art Catheter
Current-ua Time applied-sec. Response
__________________________________________________________________________
6 5 none 12 5 none 17 5 none 22 5 none 34 5 none 50 5 Ventricular
fibrillation (Stopped after current turned off) 70 5 Ventricular
fibrillation (Irreversible)
__________________________________________________________________________
From the above, it will be apparent that there is a great advantage
in the use of a catheter having at least a portion of its walls
electrically conductive or semiconductive and having an electrical
resistivity which is comparable to that of the surrounding blood
and tissues during an intracorporeal application to allow current
flow through the walls into the blood and tissue, but to provide a
significant impedance between the source of current and the end of
the inserted catheter. As explained above, this electrical
resistivity lies approximately in the range of 12 to 1,200
ohm-centimeters, and is preferably approximately at the electrical
resistivity of the surrounding blood and tissue.
It will be apparent that construction of the catheter of this
invention can be other than that described above with respect to
the preferred embodiment. For example, rings or strips of
conductive material may be embedded in an insulative material, a
portion rather than all of the catheter wall may be conductive, and
in some cases only the portion of the catheter adapted to be
adjacent to the skin during an intracorporeal application may be
conductive.
* * * * *