U.S. patent number 3,797,478 [Application Number 05/270,866] was granted by the patent office on 1974-03-19 for multi-functional valve for use in the urethra.
Invention is credited to Edward F. Costigan, Michael Adrian Walsh.
United States Patent |
3,797,478 |
Walsh , et al. |
March 19, 1974 |
**Please see images for:
( Certificate of Correction ) ** |
MULTI-FUNCTIONAL VALVE FOR USE IN THE URETHRA
Abstract
A valve adapted to be positioned in the channel of the urethra
for the maintenance of such channel at a predetermined size in a
substantially sterilized condition relative to bacteria, such valve
controlling the flow of urine from the bladder through the channel
of the urethra to the atmosphere.
Inventors: |
Walsh; Michael Adrian (Pelham
Manor, NY), Costigan; Edward F. (Scarsdale, NY) |
Family
ID: |
23033140 |
Appl.
No.: |
05/270,866 |
Filed: |
July 11, 1972 |
Current U.S.
Class: |
600/29;
128/DIG.25; 604/256; 604/916 |
Current CPC
Class: |
A61F
2/0027 (20130101); A61M 25/1002 (20130101); Y10S
128/25 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61M 25/10 (20060101); A61b
019/00 (); A61m 025/00 () |
Field of
Search: |
;128/349R,349B,349BV,1R,DIG.25,285,129,344,325 ;251/5 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
livingston - Amer. Jour. of Surgery - Vol. 51, 1941, pg.
494..
|
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Costigan; Edward F.
Claims
What is claimed is:
1. A valving device adapted for placement in the channel of the
urethra of a female for use in controlling the flow of urine from a
bladder to the atmosphere by way of such channel,
consisting essentially of:
a. a first flexible tube having solid sidewalls, an exterior
surface and an interior surface of open-end construction,
b. a second flexible tube having sidewalls provided with an
exterior surface and an interior surface of open-end
construction,
1. said sidewalls of said second tube being hollow between the
latter surfaces,
2. said second tube inserted into said first tube and extending
beyond both ends of said first tube,
3. said second tube secured in position in said first tube, and
c. means provided on the portion of said second tube which extends
beyond the end of said first tube for the inflation of the hollow
area of such second tube,
Whereby, (1) said second tube when inflated substantially closes
the area circumscribed by the interior surface of said second tube
except for a relatively thin longitudinal passageway formed by the
abutting surface of said interioral surface of said second tube,
and
Whereby, (2) said second tube when inflated forming a circular
collar surrounding each end of said first tube, said collars
adapted to maintain said first tube in position in said
urethra.
2. The device of claim 1 wherein said first flexible tube is
provided with sidewalls impregnated with bactericdal cations.
3. The device of claim 2 wherein said sidewalls are made from a
flexible plastic such as polyvinyl ethylene.
4. The device of claim 3 wherein said second tube is made of
inflatable material, such as plastic or rubber.
5. The device of claim 1 wherein the exterioral circumference of
said first tube in individual units lies uniformly between 10 mm
and 36 mm in circumference.
6. The device of claim 1 wherein the uniform length of said first
tube lies between 2 cm to 4 cms.
Description
This invention relates to the flow of urine from the bladder of a
female patient through the channel of the urethra to the
atmosphere.
More particularly, this invention relates to a valve for use in the
control of the aforesaid flow of urine.
In the past, it has been found that in some patients, the channel
of the urethra is subject to diminishment in size through natural
traumatic or disease processes. As a result, this process leads to
a condition which not only restricts the flow of urine through the
channel but may lead to discomfort and even a dangerous condition
relative to infection if the bladder is not properly voided. In
other conditions, the patient may have no voluntary control over
the process of voiding urine. Urinary leakage through the urethra
in such cases may be constant or intermittent.
In situations such as that described above, the Practitioner
usually dilates the channel of the urethra through the use of
successive insertions of sounds of a progressively increasing
circumference. When the desired circumference is attained through
such dilation, the channel will maintain this size for a time until
the process of dilation must be repeated again to bring the channel
to the desired size. If, perchance, the channel was blocked for any
appreciable period of time, a pool of stagnant urine would form in
the bladder and might produce an infection in situs which could be
transmitted to the channel of the urethra.
What is needed in the art is a device which would maintain the
channel of the urethra at the circumference desired for a
relatively extended period of time without any attendant
susceptibility to infection while naturally controlling the flow of
urine from the bladder to the atmosphere through such channel, and
preventing uncontrolled urinary leakage.
The subject invention answers the needs of the art with special
emphasis on a device which may be positively placed and securely
held in position in the channel of the urethra but which may be
easily removed when so desired.
It is therefore an object of this invention to provide a device of
improved construction which functions as a valve when placed in a
fixed position in the channel of the urethra.
Another object of this invention is to provide the aforesaid device
with the ability to substantially maintain the channel of the
urethra at a predetermined size.
An still another object is to provide the aforesaid device with the
propensity to maintain the channel in a relatively clear state
relative to bacteria when in place in the channel.
A still further object is to provide such device with the ability
to control the flow of urine from the bladder to the atmosphere
through the channel by functioning as a naturally controlled
valve.
Other objects and many of the attendant advantages of this
invention will become more apparent to those skilled in the art
upon reading the following detailed specification accompanied by
the drawings, wherein:
FIG. 1 is a sectional side elevation of the female torso.
FIG. 2 is a sectional side elevation of the device of this
invention.
FIG. 3 is a sectional side elevation of the device of FIG. 1 in the
inflated condition.
FIG. 4 is a plan view taken along line 4--4 of FIG. 2.
FIG. 5 is a plan view taken along line 5--5 of FIG. 3.
FIG. 6 is a side view of the inflation means provided on the device
of FIGS. 2 and 3.
Similar numerals refer to similar parts throughout the several
views.
For a better understanding, refer to FIG. 1 where a cross-sectional
view is shown of the device 10 in place in the body of a patient.
As may be seen from this view, the device 10 is held in a
substantially stationary position in the channel of the urethra u
by inflated collars 24 and 26 at each extremity of the device.
However, a rupture of the inflated collar 26 at the extremity of
the device 10 which is adjacent the outer surface of the body will
completely void both collars 24 and 26 and the device 10 may then
be easily removed from the channel of the urethra u.
As shown in FIG. 2, the device 10 is in condition for insertion
into the urethra u of the female patient by the specialist. The
aforesaid device 10 is provided with a hollow plastic cylinder 11
of the flexible variety having an upper end 12 and a lower end 14
both of which are in open-end construction. A longitudinal tube 13
of the elastical variety such as rubber is fitted into the cylinder
11 with extremital end portions 16 and 18 extending beyond the ends
12 and 14 of the cylinder 11.
The longitudinal tube 13 consists of two abutting walls 15 and 17
of closed end construction forming an inflatable annular ring which
circumscribes area 20 when the device is in the deflated state.
This may be clearly seen in FIG. 4. Referring again to FIG. 2, the
lower end 18 of the tube 13 is fitted with a valve 30 of the needle
type punctural variety for use in the inflation of the area 22
formed by the abutment of walls 15 and 17 of the tube 13. The
longitudinal tube 13 may be inserted in the cylinder 11 and the
inner surface 19 of the cylinder 11 may be secured or affixed to
the outer surface 21 of the tube 13 by conventional procedures.
As may now be seen from FIGS. 1 and 3, the device 10 is in the
inflated state. This may be accomplished by injecting a fluid
through valve 20 by means of a syringe 32. The fluid may be
sterilized distilled water. Note should be taken that the
extremital ends 16 and 18 of the tube 13 by its unique construction
within cylinder 11 form two hollow inflatable collars 24 and 26
which maintain the device in position in the urethra u. It may also
be seen from a comparison of FIGS. 2 and 3 that the space 22
between the walls 15 and 17 is now in the form of a longitudinal
annular chamber 22 within the cylinder 11. Further, as may be seen
from FIGS. 1, 2 and 5, the former area 20 of relatively large size
circumscribed by the wall 15 is diminished in size to that shown in
FIGS. 3 and 5 by inflation of annular chamber 28.
Referring to FIG. 6, the body of the valve 30 is provided with a
longitudinal channel 34 of closed-end construction within the
inflated area of the collar 26. The valve 30 is provided with a
flange 36 upon which a force is exerted by the adjacent lining 18
of such a magnitude that the channel 34 is forced closed even after
the insertion and withdrawal of syringe 32. However, the valve 30
may be of the self-sealing needle type valve or pressure-type
valve.
In operation, the device of FIG. 2 is inserted into the urethra u
of the female as shown in FIG. 3. After insertion, a syringe 32 is
inserted into channel 34 of the valve 30 until the tip penetrates
the area adjacent thereto. The longitudinal tube 13 is then
inflated to form an annular ring 28 within the cylinder 11 and the
portions 16 and 18 of the tube 13 extending beyond the cylinder 11
are inflated into the form of an annular collar 24 and 26. The
latter collars maintain the device 10 in position in the urethra
u.
When it is desired to remove the device 10, the inflated collar 26,
which communicates with the longitudinal area 28 and collar 24, is
ruptured or serrated. As a result, the inner tube 13 collapses and
the device may be easily removed from the body channel. However, in
an improvement of the above the valve 30 may be of inflatable and
deflatable variety which may be more economical to the Practitioner
when fitting a device of the proper size to the patient.
The cylinder 11 is relatively flexible but when in the urethra, it
is securely fixed in place. In the initial stage of the process of
extruding this cylinder, bactericidal metallic solids or cations or
other bacteriostatic or bactericidal substances tolerated by human
tissues may be introduced in the melting pot. Cations such as Cu or
Ag have been found to kill bacteria of even the most stubborn
variety. As a result, the urethra may be maintained bacteria free
when the device of the present invention is placed therein.
The volume of liquid necessary to inflate the device will be such
that the pressure exerted by the fluid will approximate a force of
approximately 90 cm to the linear passageway 20' of FIG. 3. When
such force is exceeded the urinating process takes place. And, the
patient after a relatively short period of time may find it easy to
control the voiding of the bladder by natural processes.
The external circumference of the cylinder 11 of FIG. 2 may be
manufactured in individual sizes from 10 mm to 36 mm, in this
manner, the device is customized to the channel of the individual
patient. Also, the device may be manufactured in individual lengths
between 2 cm to 4 cm as a means of customization of the device to
individual patients.
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