U.S. patent number 3,848,603 [Application Number 05/412,310] was granted by the patent office on 1974-11-19 for antiseptic catheter.
Invention is credited to Guy C. Throner.
United States Patent |
3,848,603 |
Throner |
November 19, 1974 |
ANTISEPTIC CATHETER
Abstract
Medical apparatus and method for preventing infectious organisms
from entering the body of a patient through or along a catheter.
The apparatus includes a tubular receptacle through which body
fluids flow from the catheter to a collecting reservoir, the
receptacle adapted in various ways to facilitate introduction of
antiseptic compositions from either liquid or solid form into the
body fluids to preclude survival therein of infectious organisms.
Also disclosed is apparatus for maintaning an antiseptic barrier on
the outside of the catheter where it enters the patient's body.
Inventors: |
Throner; Guy C. (Saratoga,
CA) |
Family
ID: |
23632482 |
Appl.
No.: |
05/412,310 |
Filed: |
November 2, 1973 |
Current U.S.
Class: |
604/540; 604/247;
604/265 |
Current CPC
Class: |
A61L
29/16 (20130101); A61M 25/00 (20130101); A61L
2300/404 (20130101) |
Current International
Class: |
A61L
29/16 (20060101); A61M 25/00 (20060101); A61L
29/00 (20060101); A61m 025/00 (); A61f
005/44 () |
Field of
Search: |
;128/349R,35R,275,276,278,35V |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Medbery; Aldrich F.
Attorney, Agent or Firm: Ritt, Jr.; W. W.
Claims
I claim:
1. An apparatus for preventing infectious organisms from entering
the body of a medical patient through or along a catheter for
removing body fluids, comprising:
a. a catheter having an inner end portion for insertion into a
patient's body and an outer end portion for conducting body fluids
to a collection reservoir, and
b. a means for preventing the migration of infectious organisms
through and around said catheter from a body fluid flow collection
means to a fluid flow discharge source in said body comprising a
receptacle having an antiseptic discharge contacting and mixing
means in the path of flow of said fluids whereby because of said
mixture of antiseptic and body fluids infectious organisms in said
body fluids are prevented from migrating through the catheter and
into the patient.
2. An apparatus according to claim 1 wherein the receptacle
includes an inlet for admission of body fluids and an outlet for
maintaining a liquid seal between said receptacle and the
collection reservoir.
3. An apparatus according to claim 2 wherein the receptacle
includes a perforate screen between said inlet and outlet.
4. An apparatus according to claim 2 wherein said outlet comprises
an inverted cone-shaped wall with a central opening at the bottom
end of said receptacle, said wall thereby functioning as a funnel
to collect and conduct the mixture of body fluids and antiseptic to
the central opening for subsequent passage therethrough in droplet
form.
5. An apparatus according to claim 2 wherein the inlet includes
valve means for preventing flow of liquid from said receptacle into
the catheter towards its inner end portion.
6. An apparatus according to claim 2 wherein the receptacle
includes an inlet for an antiseptic solution.
7. An apparatus according to claim 2 wherein the receptacle
includes means for supporting an antiseptic cartridge in its
interior for dissolution thereof by body fluids.
8. An apparatus according to claim 7 including an antiseptic
cartridge comprising an antiseptic and a water soluble matrix
therefor.
9. An apparatus according to claim 8 wherein the antiseptic
cartridge is replaceable.
10. An apparatus according to claim 1 including an antiseptic
ointment retainer through which the catheter's inner end portion
extends, said retainer including means for retaining an antiseptic
ointment in place between the catheter and the adjacent surface of
a patient's body when the catheter is properly installed in
functional position.
11. An apparatus according to claim 10 wherein the ointment
retainer includes a flexible sheath portion for use with male
patients.
12. An apparatus according to claim 10 wherein the ointment
retainer includes a shallow cup portion for use with female
patients.
13. A method for preventing infectious organisms from entering a
medical patient's body by the way of a catheter connected to a
collection reservoir, comprising mixing an antiseptic with
discharged body fluids flowing through the catheter to form an
antiseptic liquid barrier between the catheter and the body fluid
collection reservoir.
14. A method according to claim 13 wherein the antiseptic is in
liquid form.
15. A method according to claim 13 wherein the antiseptic is in
water soluble, solid form.
16. A method according to claim 13 including establishing and
retaining an antiseptic ointment seal between the outside of the
catheter and the adjacent surface of the patient's body.
Description
BACKGROUND OF THE INVENTION
Postoperative patients often require the implantation of a catheter
to drain the bladder because shock, induced by the operation,
renders the patient unable to release the sphincter muscles which
control the release of urine from the bladder. The catheter is used
until the patient regains muscular control and can void himself
without it. However, the longer the period the catheter is
employed, the larger is the risk of infection of the bladder,
urethra, and kidneys.
Paraplegic patients, because of injury to the spinal cord, usually
have no control over the bladder and must continuously use a
catheter of the "in-dwelling" type. The paraplegic is prone to
infection, and is almost certain to develop a bladder infection
resulting from the use of the catheter. These infections are
serious for two reasons.
First, the lack of mobility of the patient reduces the quantity of
blood flowing to the lower extremities of the body; i.e., there is
a reduced supply of blood carrying antibodies, lymphocytes, and
leukocytes because of his lack of physical activity. Therefore, his
body is not able to fight the infection effectively.
Secondly, the patient cannot survive without a catheter, for to do
so would result in possible uremic poisoning. Most paraplegic
patients develop chronic bladder and kidney infections, and in the
end succumb to the infection or the toxins produced by the
infection which cause failure of the other organs. Therefore, it is
safe to predict that most paraplegics will die from an infection
which starts in the urethra or bladder as a result of infections
introduced by the use of the catheter.
Urine and other body fluids excreted through the urethra are
mediums in which a number of organisms can flourish. Therefore, it
is easy to recognize that even when the most sterile techniques are
employed during the insertion of a catheter, there is still a path
through which infectious organisms can enter the body, that being
through the inside of the catheter directly into the bladder.
Yet another path by which infectious organisms can enter the body
is along the outside surface of the catheter. Although sterile
techniques may temporarily eliminate this path during catheter
insertion, it is possible for such organisms to migrate along the
outside of the catheter when the antiseptic effect of such
techniques has worn off.
SUMMARY OF THE INVENTION
This invention comprises an apparatus and method for preventing
infectious organisms from entering the body through a catheter. The
apparatus comprises a tubular antiseptic receptacle that is
interconnected between the catheter's outer end and the drain tube
leading from the catheter to its collecting bottle or other
reservoir. The receptacle is structured to cause the body fluids
flowing from the catheter to come into contact and mix with an
antiseptic before they continue into the drain tube, thereby
assuring that the fluids in the drain tube prevent migration of
infectious organisms into the catheter and ultimately into the
patient's body. The antiseptic can be in liquid form, in which case
it can be introduced from an external reservoir into the receptacle
dropwise or as a slow flow, or it can be in solid yet soluble form
such as a cake or cartridge that is placed in the receptacle where
body fluids will pass over or through it. The receptacle further
includes a funnel-shaped bottom wall with an outlet opening that
causes the antiseptic-body fluid mixture to form a meniscus and
then pass through the opening in droplet form, thereby assuring
that no infectious organisms in the catheter's drain tube can
migrate into the receptacle and on into the catheter without
passing through an antiseptic solution. The receptacle also
includes a check valve in its inlet portion to prevent backward
flow of fluid from the receptacle into the catheter.
The apparatus of this invention additionally comprises antiseptic
retainers suitably shaped to fit the contour of the patient's body
where the catheter enters it, and having a body-contacting surface
adapted to retain an antiseptic ointment or the like in position to
seal off entry of infectious organisms along the catheter's outer
surface. The catheter extends through these retainers into the body
orifice, and the antiseptic composition functions as an aseptic
barrier between the outside of the catheter and the orifice
entry.
Accordingly, one object of the present invention is to provide an
antiseptic catheter for prolonged use in patients without incurring
the danger of creating an infection.
Another object of the present invention is the provision of an
apparatus and method to introduce an antiseptic into the body
fluids emanating from a catheter, thereby to prevent migration of
infectious organisms through the catheter into a patient's
body.
Yet another object of the present invention is the provision of a
means to prevent infectious organisms from entering body orifices
along the outside surface of a catheter while it is in functional
position.
Further objects and advantages of the present invention will become
apparent from the following description thereof, including the
several drawings to which it refers.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a diagrammatic view in perspective of an antiseptic
catheter apparatus according to the present invention, including a
bottle of antiseptic solution and a body fluid collection bottle,
plastic bag, or the like, connected to the catheter's antiseptic
receptacle by flexible tubing.
FIG. 2 is a longitudinal section through the male antiseptic
ointment retainer at the inner end portion of the catheter of FIG.
1.
FIG. 3 is a longitudinal section through an antiseptic ointment
retainer on a catheter for use with female patients.
FIG. 4 is an isometric view of the antiseptic ointment retainer of
FIG. 3.
FIG. 5 is an isometric view, on an enlarged scale, of the
antiseptic receptacle attached to the catheter in FIG. 1.
FIG. 6 is a longitudinal section through the antiseptic receptacle
of FIG. 5.
FIG. 7 is a longitudinal section through another form of antiseptic
receptacle according to the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
As illustrated in FIG. 1, one embodiment of an antiseptic catheter
assembly 10 according the present invention comprises a catheter
12, an antiseptic receptacle 14 attached at its upper end to the
outer end of the catheter 12, a male type antiseptic ointment
retainer 16 through which the inner end of the catheter 12 extends,
and a suitable bottle or other antiseptic solution reservoir 18
connected to the antiseptic receptacle 14 by a flexible tube 20. A
body fluid collecting bottle 22 or other suitable container is
connected through a flexible tube 24 to the lower end of the
antiseptic receptacle 14, which bottle 22 functions as a holding
reservoir for body fluids flowing from the patient (not shown)
through the catheter 12, the receptacle 14, and the tube 24.
The antiseptic receptacle 14, illustrated in greater detail in
FIGS. 5 and 6, comprises a main body portion 26 with a top inlet 28
in its upper end, an outlet 30 in its lower end, and a side inlet
32 in its side wall 34 for the admission of antiseptic solution
from the bottle 18 and tube 20. The top inlet 28 serves both as a
means to admit body fluids into the receptacle 14 and as a means to
connect the receptacle to the outer end of the catheter 12. A check
valve, such as the flexible rubber lip-type device 35, is secured
to the top inlet 28 to prevent fluid flow from the receptacle 14
into the catheter 12.
The lower end 36 of the receptacle 14 is shaped like an inverted
cone with a central opening 38 at its apex, thereby to funnel and
collect the fluid in the receptacle at the opening where it then
drips into the outlet 30. When the flow of antiseptic solution into
the receptacle 14 is properly adjusted, as by a conventional
intravenous metering device 40 (FIG. 1) in tube 20, sufficient
fluid collects in the receptacle's lower conically shaped chamber
42 to assure the maintenance of an aseptic fluid seal across the
opening 38 at all times during flow into the tube 24, thereby
preventing migration of viable infectious organisms from the tube
24 upward into the receptacle. A perforate screen 44, preferably of
stainless steel, separates the conical lower chamber 42 from the
receptacle's main or upper chamber 46, and functions to trap
material, such as blood clots, that would plug up the opening 38.
It should, however, be understood that the screen 44 is optional
and can be omitted if desired. Furthermore, as long as an adequate
flow of antiseptic solution into the receptacle 14 is maintained,
i.e., sufficient to maintain the fluid seal at the opening 38, the
conical-shaped lower end 36 can be replaced by a flat end wall (not
shown).
In its preferred form, the receptacle 14 is constructed from a
clear, hard plastic for simplifying setting the proper flow rate of
antiseptic solution into it, observing the fluid level above the
opening 38, and periodic checking for buildup of material on the
screen 44. The plastic parts can be glued, ultrasonically welded,
screwed, or otherwise secured together.
A modified form of the receptacle 14 is illustrated in FIG. 7, this
form 50 designed for use with an antiseptic in solid or cake form
rather than as a solution. The receptacle 50, which incidentally is
interchangeable with the receptacle 14 where solid antiseptics are
preferred, is substantially identical in shape with the receptacle
14 except that it has no side inlet. Thus, the receptacle 50 has a
main body portion 52 with a top inlet 54 in its upper end, and a
lower end 56 shaped like an inverted cone and having an opening 58
at its apex to allow fluid to drip from a lower chamber 60 into the
outlet 62. A perforate screen 64, preferably of stainless steel,
extends horizontally between the lower chamber 60 and the main body
chamber 66, and supports a cake or cartridge 68 of antiseptic
composition that is slowly soluble in the body fluids entering the
receptacle through its inlet 54.
A check valve 70 is mounted in the inlet 54 of the receptacle 50 to
preclude flow of fluid from the receptacle into the catheter 12.
The check valve 70 illustrated in this embodiment comprises a
rubber needle valve 72 biased upwardly against a valve seat 74 by a
stainless steel or other suitable helical spring 76. Accordingly,
the check valve 70 will open in response to fluid pressure above
it, i.e., in the catheter 12, but will close if fluid pressure is
exerted in the opposite direction. Thus, flow through the
receptacle 50 only in the direction of the arrows is constantly
assured. It should be understood that other types of check valves
suitable for this function also can be used.
Although it is conceivable that the antiseptic catheter of this
invention can be used in other body orifices, or in incisions, the
principle use for which it is intended is as a bladder drain. For
example, it also can be employed as a post operative drain, in
which case a suitable antiseptic ointment retainer, to hold the
antiseptic ointment against the incision, would be substituted for
the male retainer 16.
In order that infectious organisms on the outside of the catheter
12 are prevented from entering the urethra when the catheter is in
functional position in a male patient, the antiseptic retainer 16,
illustrated in FIGS. 1 and 2, is first slipped over the catheter's
inner end portion 12a and coated on the inside with an antiseptic
ointment 80. The retainer 16 is comprised of a base portion 16a,
and a thin, flexible rubber sheath portion 16b suitably secured to
the base 16a. The retainer 16 could, of course, be a one-piece
molded article of suitable shape. When in position, the sheath 16b
holds the retainer and the ointment 80 in place.
When the patient is female, a suitably shaped retainer such as that
illustrated at 82 in FIGS. 3 and 4 is employed. The retainer 82 is
coated with antiseptic ointment 84 on the side that will fit
against the patient, and then held in place by a sanitary napkin or
other appropriate means. In both cases, the antiseptic ointment is
retained at the area of contact between the patient's body and the
external surface of the catheter, assuring an antiseptic barrier at
the juncture.
The antiseptic receptacle 14 (FIGS. 1, 5 and 6) for introduction of
antiseptic solutions in the draining body fluid is best suited for
patients in the hospital where various intravenous equipment is
readily available, such as standard for the bottle 18, flow
metering equipment 40 for the bottle 18, and the like. The
receptacle 50 (FIG. 7), however, is more suitable for patients not
confined to the hospital, as it does not require the necessary
equipment for introduction of an antiseptic solution, and can be
constructed as a throw-away element for replacement in its
entirety, if desired.
The antiseptic cake or cartridge 68 employed in the receptacle 50
(FIG. 6) preferably is an element impregnated with the desired
antiseptic in a form that is slowly soluble in the body fluids
coming in contact with it. In one form the receptacle 50 is
constructed so that it can be opened up and the cake 68 replaced,
as when the antiseptic has been dissolved away or, more preferably,
at regular intervals to assure proper potency. For example, the
cake 68 can be a compressed or polymeric pellet containing the
antiseptic in a matrix of material such as water-soluble polyvinyl
alcohol that will dissolve at a rate proportional to the quantity
of urine or other body fluid passing over it, thereby providing a
controlled or timed release of the anti-biological agent. Other
water soluble polymers presently suitable for this purpose are
polyvinylpyrrolidone, hydroxyethyl cellulose, carboxymethyl
cellulose, partially hydrolized polyvinyl alcohol, and polyethylene
oxide. It should be understood that this list of suitable
compositions is merely illustrative, and that the invention is not
limited thereto.
As will be appreciated, various antiseptic and other biocidal or
anti-biotic agents can be successfully employed with the present
invention. For example, mercurial compounds, sulfa compounds, broad
spectrum antibiotics, phenols, hydrogen peroxide, hexachlorophene,
iodine, halogen complexes, betadyne, formalin and formaldehyde,
sodium hypochlorite and other halogen salts, acetaldehydes, and
many other substances known to have biocidal or anti-biotic
properties can be dispersed in the aforementioned soluble polymers
and released at a controlled rate, thereby providing aseptic
conditions within the catheter's drain or collection tube 24 and
the collection bottle 22 for extended periods of time. The time can
be controlled by the selection of a polymer having the proper
solubility, and it should be apparent that powerful biocides can be
used with slowly dissolving polymers while weaker biocides may
require a more quickly dissolving polymer to maintain the desired
aseptic conditions.
The antiseptic and antibiological agents listed above also can be
used in the form of aqueous, alcoholic, or other solutions for
controlled rate metering into the catheter's receptacle 14 by
conventional intravenous equipment. Other materials providing the
necessary antiseptic environment can be prescribed by the attending
physician, and added to these listed agents or used in lieu
thereof. In each case the solution should have a low vapor pressure
so that vapors will not migrate up the catheter 12 into the
patient's body.
Although the best mode contemplated for carrying out the present
invention has been herein shown and described, it will be apparent
that modification and variation may be made without departing from
what is regarded to be the subject matter of the invention.
* * * * *