U.S. patent number 3,583,391 [Application Number 04/777,728] was granted by the patent office on 1971-06-08 for medical instrument with outrolling catheter.
This patent grant is currently assigned to Pharmaseal Division of American Hospital Supply Corporation. Invention is credited to Clair E. Cox, Andrew Harautuneian, Frank Hinman, Jr..
United States Patent |
3,583,391 |
Cox , et al. |
June 8, 1971 |
MEDICAL INSTRUMENT WITH OUTROLLING CATHETER
Abstract
A medical instrument for positioning an elongated sac or
catheter in a pathient's urethra for urinary drainage or bacterial
sampling. The elongated sac fits in a bore of a flexible insertion
tube. One end of the sac extends from a front end of this tube and
is secured to a rigid tubular guide sleeve encircling a portion of
the flexible introducer tube. As the flexible insertion tube is
pushed forward, the insertion tube extends out of the guide sleeve
into the urethra and the sac rolls out over a front end of the
insertion tube into contact with the urethra.
Inventors: |
Cox; Clair E. (Winston-Salem,
NC), Hinman, Jr.; Frank (San Francisco, CA),
Harautuneian; Andrew (Gardewa, CA) |
Assignee: |
Pharmaseal Division of American
Hospital Supply Corporation (Glendale, CA)
|
Family
ID: |
25111073 |
Appl.
No.: |
04/777,728 |
Filed: |
November 21, 1968 |
Current U.S.
Class: |
600/585; 604/38;
604/540 |
Current CPC
Class: |
A61M
25/0111 (20130101); A61M 25/0119 (20130101); A61M
2025/0062 (20130101) |
Current International
Class: |
A61M
25/01 (20060101); A61b 005/10 (); A61m
025/00 () |
Field of
Search: |
;128/2,262,348--350,356 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Baller "Dermatologische Zeitschrift" Vol. 32, 1921, pp. 39--46
128--262.
|
Primary Examiner: Truluck; Dalton L.
Claims
We claim:
1. A medical instrument for everting an elongated sac and inserting
it into a body orifice, said instrument comprising:
a flexible insertion tube having a forward and rearward end;
an elongated tubular sac within a bore of the insertion tube,
one end portion of the sac being removably disposed in the bore and
extending over the forward end of the inserting tube;
an elongated, rigid guide sleeve substantially longer than the
insertion tube diameter and reciprocably embracing a forward
section of the insertion tube adjacent the insertion tube's forward
end,
said guide sleeve including abutment means at the forward distal
end for preventing the guide sleeve from entering a body opening,
said tubular guide sleeve keeping the forward section of the
insertion tube from laterally bending before and as it enters a
body orifice, said sac's other end portion being reversibly secured
to rearwardly of the forward distal end of the tubular guide
sleeve, the insertion tube being of such a character than when
longitudinal force is applied thereon rearward of the forward
distal end of the rigid guide sleeve, the insertion tube is urged
longitudinally along the bore of the tubular guide sleeve and
pushes the forward end of the insertion tube out of the tubular
guide sleeve beyond the distal end thereof, thereafter pulling the
sac out of the insertion tube's bore, turning the sac inside out on
the outer surface of the insertion tube and laying it down along an
inside surface of the body orifice.
2. A medical instrument as set forth in claim 1 wherein the
instrument has means connected to the insertion tube for urging it
longitudinally along the guide sleeve.
3. A medical instrument for everting an elongated sac and inserting
it into a body orifice, said instrument comprising: a flexible
insertion tube having a forward and rearward end; an elongated
tubular sac within a bore of the insertion tube, an end portion of
the sac extending from the forward end of the insertion tube; an
elongated, rigid tubular guide sleeve encircling a section of the
insertion tube adjacent the insertion tube's forward end, which
tubular guide sleeve keeps this section of the insertion tube from
laterally bending before entering a body orifice, said sac's end
portion being secured to this tubular guide sleeve, whereby the
insertion tube can be urged longitudinally along an inside of the
tubular guide sleeve to push the forward end of the insertion tube
out of the tubular guide sleeve, thus pulling the sac out of the
insertion tube's bore, turning the sac inside out on an outer
surface of the insertion tube and laying it down along an inside
surface of a body orifice, the instrument having means connected to
the insertion tube for urging it longitudinally along the guide
sleeve, the guide sleeve having at least one longitudinal slot and
the means for urging the insertion tube along the guide sleeve is a
rigid handle attached to the insertion tube and extending outwardly
through the longitudinal slot.
4. A medical instrument as set forth in claim 3 wherein the handle
includes a rigid C-shaped tube segment fitting over the insertion
tube.
5. A medical instrument as set forth in claim 1 wherein the guide
sleeve has a pair of diametrically opposed longitudinal slots and
the instrument has a handle with a rigid C-shaped tube segment
fitting over the insertion tube, said handle also having a pair of
integrally attached diametrically opposed thumb pads which extend
outwardly through the two elongated slots.
6. A medical instrument as set forth in claim 3 wherein the handle
abuts a front end of the slot when the flexible sac is completely
pulled out of the insertion tube's bore and a forward end of the
insertion tube extends slightly beyond the flexible sac.
7. A medical instrument as set forth in claim 1 wherein the
flexible sac inside the insertion tube's bore has a string member
attached thereto, said string member extending outwardly through a
rearward end of the insertion tube for pulling the sac back inside
the insertion tube after it has been inserted into a body
cavity.
8. A medical instrument as set forth in claim 1 wherein the
insertion tube has an adapter at its rearward end for connecting to
a fluid conduit.
9. The medical instrument as set forth in claim 1 wherein the means
at the forward distal end of the rigid guide sleeve includes a
generally oval-shaped shield.
10. A medical instrument as set forth in claim 3 wherein the rigid
guide tube includes a finger flange integral therewith and spaced
between the longitudinal slot and the guide tube's forward end.
11. A medical instrument for everting an elongated sac and
inserting it into a body cavity, said instrument comprising: a
flexible insertion tube having a forward end and a rearward end; an
adapter on said rearward end for connection to a fluid conduit; an
elongated tubular sac within a bore of the insertion tube and
having an end portion of the sac extending from the forward end of
the insertion tube; a rigid tubular guide sleeve substantially
longer than the insertion tube's diameter fitting around the
insertion tube, said tubular guide tube having a shield at its
forward end, a pair of longitudinal slots spaced rearward of the
shield, and an external finger flange spaced between said shield
and slots; a handle including a rigid C-shaped tube segment fitting
over the insertion tube and secured thereto, and a pair of thumb
pads integrally connected to the C-shaped tube segment and
extending outwardly through said slots, whereby an operator can
grasp the thumb pads and finger flange and urge the insertion tube
out of the tubular guide sleeve, thus causing the sac to be pulled
out of the insertion tube, turned inside out on an outer surface of
the insertion tube and laid down along an inside surface of a body
cavity.
12. A medical instrument as set forth in claim 11 wherein the
insertion tube and at least a portion of the guide sleeve are
transparent so an operator can observe liquid flow
therethrough.
13. The medical instrument as set forth in claim 1 in which said
flexible insertion tube includes an intermediate preformed section
for accommodating the insertion tube to natural curvatures of a
body orifice.
14. The medical instrument as claimed in claim 1 in which the inner
and outer surfaces of said insertion tube adjacent the forward end
include a lubricant coating for facilitating rolling of the sac
over the forward end of the insertion tube.
Description
This invention relates to a medical instrument for everting an
elongated sac or catheter and inserting it through an opening and
into a body cavity such as the urethra. This is particularly useful
for obtaining samples of microorganisms from different areas of the
urethra, or for inserting a tube into the urinary bladder without
transferring microorganisms from the meatus and distal urethra to
other areas of the urinary tract.
Devices with outrolling catheters which accomplish these feats have
been proposed in the past. A very early example of such a device is
described and illustrated in an article entitled "A New Method for
the Prevention of Intraurethral Spreading of Germs Caused by the
Insertion of Catheter and Irrigation of the Urethra" by Georg
Baller in Dermat. Ztschr. (now Dermatologica) V. 32, p. 39--46
(1921). Work on a similar outrolling catheter device as was done by
Henry F. Helmholz, Sr. and reported as "Determination of Bacterial
Content of the Urethra: A New Method, with Results of a Study of 82
Men," Journal of Urology, Volume 64, pages 158--166 (1950).
These prior art devices of Baller and Helmholz included a rigid
metal insertion tube and a rigid disc with a center hole which
slidingly fits over the insertion tube. A flexible rubber sac or
cot was attached at one end to the disc. The other end was
telescoped into a bore of the metal insertion tube. When the disc
was near a forward end of the insertion tube, nearly all the
flexible sac was inside the insertion tube. In use, a nurse or
physician placed the disc against the urethral meatus. He than then
pushed the metal insertion tube through the disc and into the
urethra. As the insertion tube advanced, the rubber sac was pulled
out of the tube's bore, turned inside out as it rolled over a front
end of the insertion tube and was laid down along the urethra.
By visualizing how these outrolling catheter devices work, one can
see that the sac or catheter is evaginated during insertion. This
is important because it has been found that the first centimeter of
the distal area of the urethra often contains a high bacterial
count. Areas of the urethra nearer the bladder usually contain few
bacteria or may be sterile. With a sterile outrolling catheter
device, it is possible to insert the catheter along the entire
length of the urethra into the bladder without transferring
bacteria, which could cause infection, from the distal to the
proximal areas of the urinary tract.
The flexible sac of these devices can be used for either urinary
drainage as explained above or can be used for taking bacterial
samples at various points along the urethra. In this latter use,
these bacterial samples can be used for culture tests in diagnosing
a patient's particular urological problem. In this second use, the
sac has a pull string tied to an end of the sac within the
insertion tube. After the flexible sac has been placed in the
urethra, this string is pulled to invert the sac and pull it back
into the insertion tube as the device is removed. The sac now has
bacterial samples from various points along the urethra, and a
physician can identify the bacteria and estimate their
concentrations at, for instance, 1, 2, 3 and 4 cm. distances from
the urethral meatus.
The foregoing was to explain how the prior art outrolling catheters
worked so the present invention could be understood. In the prior
art devices a rigid metal tube was used to insert the flexible sac.
A rigid metal tube can be painful to a patient, particularly if he
moves and the stiff tube in his urethra is cocked to one side.
Metal tubes were used despite patient discomfort because they had
sufficient columnar rigidity to penetrate the urethra and evert the
flexible sac. Flexible plastic insertion tubes have been suggested,
but these lack the columnar rigidity of metal tubes and tend to
kink and bend when shoved toward the urethra.
The present invention overcomes these difficulties in the previous
outrolling catheter devices by providing a flexible plastic
insertion tube minimizing patient discomfort, a flexible sac for
insertion into the urethra, and a rigid guide sleeve surrounding
the flexible insertion tube. The rigid guide sleeve provides
columnar rigidity to the flexible insertion tube but does not
itself enter the urethra.
Illustrations of three embodiments of this invention are shown in
the attached drawings, in which:
FIG. 1 is a side elevational view of the medical instrument used
for inserting a flexible sac into a body cavity;
FIG. 2 is an enlarged longitudinal sectional view partially in
section of the medical instrument;
FIG. 3 is a cross-sectional view taken along line 3-3 of FIG.
2;
FIG. 4 is a cross-sectional view taken along line 4-4 of FIG.
2;
FIG. 5 is a cross-sectional view taken along line 5-5 of FIG.
2;
FIG. 6 is a fragmentary longitudinal sectional view of a forward
portion of one embodiment of the medical instrument showing it used
for urinary drainage;
FIG. 7 is a view similar to FIG. 6 of a second embodiment of the
medical instrument showing it being used for obtaining bacterial
samples from a urethra; and
FIG. 8 is a fragmentary sectional view of a forward portion of a
third embodiment showing a preformed curve in an insertion
tube.
Referring to these drawings in detail, FIGS. 1--6 show a first
embodiment of the invention particularly suited for inserting a
flexible sac into a female patient's urethra without pushing
bacteria from the meatus into the bladder. Once inserted, the sac
has a flexible insertion tube inside, through which urine can flow.
It is important to this invention that the insertion tube be
laterally flexible so it can follow any natural contour of the
urethra and not cause excessive pain if the patient moves while the
insertion tube and sac are in the urethra.
The medical instrument includes a flexible insertion tube 1 with a
forward end 2 and a rearward end 3. A thin plastic sac 4 of layflat
plastic tubing is telescoped into the insertion tube's bore at its
forward end 2 and an end portion 5 of the sac extends out of the
insertion tube and is attached to a rigid guide sleeve 6. The sac
can be everted and laid down along an inside surface of the urethra
by holding guide sleeve 6 and shoving the insertion tube into the
urethra.
As mentioned, the instrument includes the rigid guide sleeve 6
surrounding the flexible insertion tube. This guide sleeve is
substantially longer than the insertion tube's diameter and has
four parts, namely: a forward, generally oval-shaped shield 7
adapted to be pressed against the area surrounding the meatus; a
first tubular section 8; a second tubular section 9; and a rear cap
10. All of these parts are joined together to form an elongated
rigid member. As shown in FIGS. 1 and 2, the second tubular section
9 has a pair of diametrically opposed slots 11 and 12 providing
access to the introducer tube through the guide sleeve 6. A handle
13 is attached to the flexible insertion tube at these slots for
urging the insertion tube longitudinally along the guide sleeve.
The handle includes a rigid C-chaped tubular segment 14 surrounding
the insertion tube and a pair of diametrically opposed thumb pads
15 and 16 integrally joined to the C-shaped tubular segment 14.
These thumb pads extend outwardly through the slots 11 and 12.
An operator can easily operate the instrument with one hand by
grasping a finger flange 17 on first tubular section 8 and one
thumb pad, and thereafter pushing the thumb pad toward finger
flange 17. This pushes a forward end of the insertion tube out of
the guide sleeve, and thus everts the sac 4 and lays it down along
the inside surface of the urethra. Calibrations 33 show how far the
insertion tube has been pushed into the urethra. The insertion tube
continues into the urethra until sac 4 is entirely pulled out of
the insertion tube's bore and the insertion tube extends a short
distance beyond the end of the sac as shown in FIG. 6. This insures
that the sac will not block the insertion tube's bore and slow down
urine flow. The thumb pads abut forward ends of the slots 11 and 12
when the insertion tube is fully inserted, as in FIG. 6. Next, a
conduit (not shown) leading to a drainage container is connected to
an adapter 18 at the rear of the introducer tube and urinary
drainage begins. After the urine in the patient's bladder has been
drained, the insertion tube and sac are pulled out of the urethra
and discarded.
A second embodiment of the invention is shown in FIG. 7. Here, the
medical instrument is intended for use in taking bacterial samples
along a female urethra to determine the types and concentration of
bacteria at different depths in the urethra. This instrument is
identical to the instrument of FIGS. 1--6, except that here a
string 22 is tied to the end 20 of flexible sac 19 within the bore
of flexible insertion tube 21, and said string extends out through
a rear portion of the insertion tube. The sac also has a series of
depth marks 23, 24, 25 and 26 to indicate for instance the 1 cm., 2
cm., 3 cm. and 4 cm. positions in the urethra.
In use, this second embodiment is inserted in the same way as the
embodiment of FIGS. 1--6, but the sac 19 is not completely pulled
out of the insertion tube's bore. Instead, after the sac has been
inserted a given distance into the urethra to contact its inner
surface and pick up bacterial samples, the sac is pulled back into
the insertion tube 21. If desired, a hole 27 can be provided in the
sac near where the string 22 is tied to it. This allows urine to
flow through the sac so the sac is not filled with urine when it is
pulled back into the insertion tube. After the flexible insertion
tube and sac have been removed from the urethra, the sac which now
has bacterial samples on its inside surface can be cut into 1 cm.
segments and tests run to determine the bacterial types and
concentrations at various depths in the urethra.
A third embodiment of this invention is shown in the sectional side
elevational view of FIG. 8. Here the instrument is the same as the
instrument shown in FIGS. 1--6, but the flexible insertion tube 31
has a preformed curved section 32 so it conforms more naturally to
the contour of the urethra. To help maintain this curved shape, the
guide sleeve can also be curved. This preformed curved section 32
in the insertion tube can be formed by taking a section of flexible
extruded tube, bending it to the desired curvature and then heating
it in an oven to a temperature below its melting point so the tube
takes on a permanent set or curve. As the insertion tube 31 is
pushed out of rigid guide sleeve, it smoothly follows the curved
urethra as shown in FIG. 8. If desired, the rigid tubular guide
sleeve can also be curved.
The medical instruments of these embodiments are made in a similar
way. In describing how they are made, it suffices to refer to the
version shown in FIGS. 1--6. The insertion tube 1 is made of a
flexible polyvinyl chloride tube, and sac 4 is a layflat
polyethylene sac which has sufficient flexibility and strength for
rolling over the insertion tube's end. To aid in rolling the sac
over the insertion tube's end, the inner and outer surfaces of the
insertion tube have been coated with silicone oil. To hold the sac
to the rigid guide sleeve, the sac has its end portion wedged
between shield 7 and first tubular section 8. There is no adhesive
bond here so that the sac can be removed if desired. Removal of the
sac is important in the second embodiment where the sac contains
bacterial samples.
Moving rearwardly from the front shield, the first and second
sections 8 and 9 are joined together at a joint 28 which can be a
solvent joint. The first section preferably is of a transparent
material such as polycarbonate so urine can be observed flowing
through the transparent insertion tube. The second tubular section
9 has slots 11 and 12 which extend completely to a rear end of this
section, and a cap member 10 with inner and outer skirts 29 and 30
fits over the rear end of tubular section 9 and sealed thereto to
hold it in a circular shape.
As mentioned previously, the flexible insertion tube is urged
forward along the rigid guide sleeve by a handle 13 which has a
C-shaped tube segment 14. During assembly of the instrument, the
flexible insertion tube is squeezed into a mouth of the C-shaped
tube segment 14. To insure that the handle does not slip on the
insertion tube, it is sealed by a solvent or adhesive to the
insertion tube.
In the foregoing description of our invention, we have described
the instrument as inserting a flexible sac into a female urethra.
The invention is also adaptable for inserting a sac in a male
urethra merely by making the sac, insertion tube and guide sleeve
longer.
Although we have used specific embodiments to describe our
invention, it is understood that persons skilled in the art can
make certain modifications to the embodiments without departing
from the spirit and scope of the invention.
* * * * *