U.S. patent number 3,646,929 [Application Number 04/883,450] was granted by the patent office on 1972-03-07 for female incontinence device.
This patent grant is currently assigned to National Research Development Corporation. Invention is credited to John Bonnar.
United States Patent |
3,646,929 |
Bonnar |
March 7, 1972 |
FEMALE INCONTINENCE DEVICE
Abstract
A female incontinence device comprising a support adapted for
insertion into and stable retention in the vagina, a flexible
diaphragm engaged at its periphery with the support, and remotely
operable means carried by the support to elevate the diaphragm
relative to the support and thereby upwardly displace both the
urethra and bladder neck, while slightly elongating the
urethra.
Inventors: |
Bonnar; John (Glasgow,
SC) |
Assignee: |
National Research Development
Corporation (London, EN)
|
Family
ID: |
10482191 |
Appl.
No.: |
04/883,450 |
Filed: |
December 9, 1969 |
Foreign Application Priority Data
|
|
|
|
|
Dec 10, 1968 [GB] |
|
|
58,688/68 |
|
Current U.S.
Class: |
600/29;
128/DIG.25; 606/119; 128/884 |
Current CPC
Class: |
A61F
2/005 (20130101); Y10S 128/25 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61b 019/00 () |
Field of
Search: |
;128/1,118,127,129,133,295,344,325,327,346 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
I claim:
1. A female incontinence device comprising:
a. a vaginal insert body having:
a first generally triangular shape in side view, said shape
including a base, a first side, and a second side, for respective
longitudinal, inferior, and superior disposition in the vagina, the
insert body also having a second generally triangular shape in plan
view, with a first upper surface portion, including said first
side, converging towards the inferior end of said body, and a
second upper surface portion, including said second side, diverging
towards the superior end of said body, and a cavity opening into an
aperture in said first upper surface portion;
b. a flexible resilient diaphragm located across said aperture;
and
c. expandable inflation means located in said cavity and remotely
operable to elevate said diaphragm from said first upper surface
portion to an expanded position wherein said diaphragm can apply
pressure to the urethra, said means also being operable to permit
return of said diaphragm to its initial position whereby pressure
on the urethra is relieved.
2. A device according to claim 1 wherein said body has an
undersurface, including said base, which is concave in the lateral
direction.
3. A device according to claim 1 wherein said cavity has opposed
sidewall portions in the longitudinal sides of said second shape
which overhang said undersurface.
4. A device according to claim 1 wherein the part of said body
defining the rim of said aperture is turned over into said cavity
to form an annular groove, and said device comprises a spring
seated in said groove to retain said diaphragm located across said
aperture.
5. A device according to claim 1 wherein said inflation means
comprises a balloon located in said cavity, a collapsible fluid
reservoir located externally of said body, a flexible tube
communicating said balloon and reservoir to form a sealed fluid
system, and means for mutually isolating the interiors of said
balloon and said reservoir.
Description
This invention relates to an incontinence device.
The object of the invention is to provide a device which can be
inserted into a female patient and enable the patient or her
attending nurse to have control over incontinence of urine.
According to the present invention there is provided a female
incontinence device comprising a support adapted for insertion into
and stable retention in the vagina, a flexible diaphragm engaged at
its periphery with said support, and remotely operable means
carried by said support to elevate said diaphragm relative to the
support and thereby to upwardly displace both the urethra and
bladder neck, while slightly elongating the urethra.
The alteration of the relationship between the urethra and the
bladder by the upward displacement of the urethra is the action
whereby the device achieves continence of urine.
The pressure of the diaphragm on the urethra from the vagina may
also assist in achieving continence by improving the resistance of
the urethra to the involuntary escape of urine. When
intra-abdominal pressure is raised no escape of urine takes place
from the urethra when the diaphragm is elevated.
The support of the proposed device preferably takes the form of a
suitably anatomically shaped member mould from acrylic or other
plastics material which is acceptable from both the medical and
production points of view.
Preferably the remotely operable means for elevating the diaphragm
takes the form of a fluid expansible vessel. In the case of a
molded support member, the member is conveniently hollowed to
receive a vessel in the form of a balloon held captive in the
support member hollow by the diaphragm. The fluid for expanding the
vessel, such as air for inflating a balloon-form vessel, can be
supplied via a narrow flexible tubing from an external reservoir or
a simple hand pump.
The diaphragm itself can be a simple contraceptive type of
diaphragm made of rubber or other flexible material incorporating a
metal ring or spring around its edges, which holds the diaphragm in
place by engagement in a suitable seating in the support.
In the case where a fluid expansible vessel is used, it is possible
that the diaphragm may be unnecessary if the vessel is otherwise
connected with the support.
The invention has particular application in women with urinary
incontinence who are not suitable for surgical treatment or who
have not been improved by operations aimed at restoring continence.
Where the patient is in such circumstances that she cannot follow
the simple instructions then the nurse or attendant can easily
operate the device to keep the patient free of incontinence of
urine.
In order that the invention may be more fully understood, the same
will now be described, by way of example, with reference to the
accompanying drawings, in which:
FIGS. 1 and 2 are longitudinal sections through a device according
to the invention showing the diaphragm lowered in FIG. 1 and
elevated in FIG. 2,
FIGS. 3 and 4 are transverse sections through the same device again
with the diaphragm lowered and elevated, respectively,
FIGS. 5 and 6 show a closed pneumatic system for elevating and
lowering the diaphragm of a device such as that illustrated by
FIGS. 1 to 4, and
FIG. 7 illustrates the device in plan view.
The device illustrated in FIGS. 1 to 4 and 7 comprises an
anatomically shaped support member 10 molded from acrylic plastics
material. The member 10 is formed with a hollow to form a chamber
11 when covered by a rubber diaphragm 12. The diaphragm 12 is held
in place around its periphery by a retaining spring 13 received by
a seating 13a formed around the mouth of the hollow in the support
member.
Within the chamber 11 is a rubber balloon 14 adapted to be supplied
with air through a flexible tube 15. The flexible tube 15 and
balloon 14 are also shown in FIGS. 5 and 6 and the tube 15 is
connected to a rubber air reservoir 16 via a valve 17 which
consists of a simple compression roller clip. The rubber reservoir
16 has an air filling valve 18. In FIG. 5 the reservoir 16 is shown
full of air and the balloon 14 is deflated, but in FIG. 6 the
reservoir 16 is compressed and the air has gone into the balloon
14.
The air reservoir 16 might alternatively have been made of
polythene or other flexible plastics material.
In use the device is inserted into the vagina, the end marked 10a
being the posterior end and the end marked 10b being the anterior
end. When the patient wishes to micturate she allows the air to
pass from the internal balloon 14 to the reservoir 16 by operating
the compression roller clip valve 17. After micturation is complete
the external reservoir is compressed which will inflate the
internal balloon. The roller clip is then closed to maintain air
within the balloon.
The external reservoir can initially be filled by means of a
disposable plastic syringe via valve 18.
As clearly shown in the drawing, the female incontinence device
includes a vaginal insert body which is generally triangular in
side silhouette (FIGS. 1 and 2), the triangular form including a
base, a first side, and a second side, for respective longitudinal,
inferior, and superior disposition in the vagina. Near its inferior
end, the vaginal insert body is generally triangular in top plan
view, having a first upper surface portion, including said first
side, converging towards the inferior end of said body, a second
upper surface portion, including said second side diverging towards
the superior end of said body, and a cavity opening into an
aperture in said first upper surface portion. There is a flexible
diaphragm 12 located across said aperture and inflation means 14
located in said cavity and remotely operable via 15 to elevate said
diaphragm from said first upper surface portion. The body 10 has an
undersurface, including said base, which is concave in the lateral
direction (FIGS. 3 and 4). The cavity 11 has opposed sidewall
portions (FIGS. 3 and 4) at its longitudinal sides which overhang
said undersurface. Part of the body defining the rim of the
aperture is turned over into the cavity 11 to form an annular
groove (FIGS. 1-4), and a spring 13 seated in the groove to retain
the diaphragm 12 located across the aperture. The inflation means
includes a balloon 14 located in the cavity, a collapsible fluid
reservoir 16 (FIGS. 5 and 6) located externally of said body, a
flexible tube 15 communicating the balloon and reservoir to form a
sealed fluid system, and means such as a clip 17 for mutually
isolating the interiors of the balloon and the reservoir.
* * * * *