U.S. patent application number 09/767208 was filed with the patent office on 2001-05-31 for valve and methods for urinary control.
Invention is credited to Deininger, Steven T., Johnson, Richard M..
Application Number | 20010002428 09/767208 |
Document ID | / |
Family ID | 21875233 |
Filed Date | 2001-05-31 |
United States Patent
Application |
20010002428 |
Kind Code |
A1 |
Deininger, Steven T. ; et
al. |
May 31, 2001 |
Valve and methods for urinary control
Abstract
A valve for a body orifice is a tube formed of a flexible
polymer with an inlet fixed across the orifice and an outlet away
from the orifice. A flange is about the inlet to interface with the
orifice. A passage in the tube extends from the inlet along an
axis. A wall of the tube is between the inlet and the outlet and
has a barrel shape tapered to the inlet and the outlet and wider
therebetween. The wall extends between an inside and an outside. A
hinge about the tube is in the wall at the barrel shape. The hinge
is an area of preferential bending so the tube is either a barrel
or flipped with the outlet folded about the hinge into the passage.
The outlet has holes through the wall with each in a plane
substantially normal to the axis and away from the inlet and
axially beyond the hinge. A seat within the tube is on the inside
of the wall in the passage to engage the outlet when the tube is
flipped into the passage by bending the hinge acutely as the outlet
is moved along the axis to the inlet and against the seat. The
outlet surrounds a bottom of the tube and when flipped the bottom
moves axially into the passage locating the holes in the seat with
the bottom closing the inlet. A duct in the inlet surrounds it so
the duct, the flange and the tube have fluid communication with the
orifice. The tube is circular and symmetrical with its axis and the
inlet and outlet are substantially normal to the axis. The outlet
has a grip projecting therefrom for use in pulling and flipping the
hinge to open the passage between the inlet and outlet. A method of
making the valve has steps of forming the tube of a flexible
material, having the inlet placed across the orifice and an outlet
away from the orifice, locating the flange about the inlet to
interface about the orifice, extending the passage through the tube
from the inlet along the axis, having the wall on the tube to taper
toward the inlet and the outlet, locating the hinge about the tube
and in the wall for bending so the tube is either normally barrel
shaped or flipped with the outlet folded about the hinge into the
passage, locating the seat inside the wall to engage the outlet
when the tube is flipped by bending the hinge acutely so the outlet
is moved along the axis toward the inlet and holds against the
seat. A method of using has the step of flipping the tube by
bending the hinge acutely so the outlet is moved toward the inlet
and held against the seat. The method of using has the step of
unfolding the acutely bent hinge by pressurizing the seat at the
inlet to unseal the outlet or pressing about the hinge to flip the
outlet from the seat.
Inventors: |
Deininger, Steven T.;
(Edina, MN) ; Johnson, Richard M.; (Minnetonka,
MN) |
Correspondence
Address: |
Attn: James W. Inskeep
OPPENHEIMER WOLFF & DONNELLY LLP
Suite 700
500 Newport Center Drive
Newport Beach
CA
92660
US
|
Family ID: |
21875233 |
Appl. No.: |
09/767208 |
Filed: |
January 22, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09767208 |
Jan 22, 2001 |
|
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09034250 |
Mar 4, 1998 |
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6200261 |
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Current U.S.
Class: |
600/29 ; 137/843;
251/349 |
Current CPC
Class: |
Y10T 137/7879 20150401;
A61F 2/0009 20130101 |
Class at
Publication: |
600/29 ; 251/349;
137/843 |
International
Class: |
A61F 002/00; F16K
015/14; F16K 031/00 |
Claims
What is claimed is:
1. A valve adapted for closing a body orifice, the valve
comprising: a bulbous tube formed of a flexible material, the
bulbous tube having an inlet fixed across the body orifice and an
outlet positioned away from the body orifice; a passage within the
bulbous tube for extending from the inlet along an axis
therethrough between the inlet and outlet; a wall of the bulbous
tube, the wall between the inlet and the outlet, the wall having a
barrel shape tapering toward the inlet and the outlet thus the
bulbous tube being wider therebetween, the wall between an inside
and an outside; a hinge about the bulbous tube, the hinge located
in the wall substantially wherein the barrel shape wall defines the
passage, the hinge as an area of preferential bending so the
bulbous tube is normally flipped with the outlet folded about the
hinge into the passage, and a seat within the bulbous tube, the
seat located on the inside of the wall, the seat disposed within
the passage to engage the outlet when the bulbous tube is flipped
into the passage by bending the hinge acutely so the outlet is
moved along the axis toward the inlet so the outlet is held against
the seat to seal the inlet and close the passage.
2. The valve of claim 1 wherein the outlet has one or more holes
dispose through the wall, each hole located in a plane
substantially normal to the axis and away from the inlet and
axially beyond the hinge.
3. The valve of claim 2 wherein the outlet surrounds a bottom of
the bulbous tube so that when the flipped bulbous tube moves the
bottom axially into the passage, the bottom locates the one or more
holes dispose through the wall in contact with the seat and
positions the bottom to close the inlet.
4. The valve of claim 2 wherein the outlet includes a plug
supported from the wall and within the outlet by a web so that when
the flipped bulbous tube moves the plug axially through the passage
the plug contacts the seat and closes the inlet.
5. The valve of claim 4 wherein the inside of the wall about the
inlet includes a pipe depending therefrom and into the passage so
the seat is on the pipe away from the inlet, the seat on the pipe
adapted to engage the plug for remotely closing the inlet.
6. The valve of claim 1 wherein the inlet includes a duct
positioned thereabout to surround the inlet and extend passage away
from the outlet, the duct, the flange and the bulbous tube adapted
for fluid communication with the body orifice.
7. The valve of claim 1 wherein the bulbous tube is circular in
cross section and substantially symmetrical about the axis and the
inlet and outlet are substantially normal to the axis.
8. The valve of claim 1 wherein the bulbous tube is formed of a
flexible polymer and the hinge is bistable so the bulbous tube is
either normally barrel shaped or flipped with the outlet folded
about the hinge into the passage.
9. The valve of claim 1 wherein the outlet includes a grip
projecting therefrom for use in pulling the outlet to flip the
hinge and open the passage between the inlet and outlet.
10. A valve adapted for closing a body orifice, the valve
comprising: a bulbous tube formed of a flexible polymer, the
bulbous tube having an inlet fixed across the body orifice and an
outlet positioned away from the body orifice; a passage within the
bulbous tube for extending from the inlet along an axis
therethrough; a wall of the bulbous tube, the wall between the
inlet and the outlet, the wall having a barrel shape tapering
toward the inlet and the outlet thus the bulbous tube being wider
therebetween, the wall between an inside and an outside; a hinge
about the bulbous tube, the hinge located in the wall substantially
wherein the barrel shape wall defines the passage as wider, the
hinge as an area of preferential bending so the bulbous tube is
normally flipped with the outlet folded about the hinge into the
passage, the outlet has one or more holes dispose through the wall,
each hole located in a plane substantially normal to the axis and
away from the inlet and axially beyond the hinge, and a seat within
the bulbous tube, the seat located on the inside of the wall, the
seat disposed within the passage to engage the outlet when the
bulbous tube is flipped into the passage by bending the hinge
acutely so the outlet is moved along the axis toward the inlet and
held against the seat, the outlet surrounds a bottom of the bulbous
tube so that when the flipped bulbous tube moves the bottom axially
into the passage the bottom locates the one or more holes dispose
through the wall in contact with the seat and positions the bottom
to close the inlet.
11. The valve of claim 10 wherein the inlet includes a duct
positioned thereabout to surround the inlet and extend passage away
from the outlet, the duct, the flange and the bulbous tube adapted
for fluid communication with the body orifice.
12. The valve of claim 10 wherein the bulbous tube is circular in
cross section and substantially symmetrical about the axis and the
inlet and outlet are substantially normal to the axis and a flange
located around the inlet of the bulbous tube, the flange with a
generally flat ring shaped configuration to circumscribe the inlet
and to interface about the body orifice;
13. The valve of claim 10 wherein the outlet includes a grip
projecting therefrom for use in pulling the outlet to flip the
hinge and open the passage between the inlet and outlet.
14. A method of making a valve adapted for closing an orifice, the
method including the steps of: forming a bulbous tube of a flexible
material; having on the bulbous tube an inlet fixed for placement
across the orifice and an outlet positioned away from the orifice;
extending a passage within the bulbous tube from the inlet along an
axis therethrough; having a barrel shaped wall on the bulbous tube,
the wall tapering toward the inlet and the outlet and thus wider
therebetween, the wall between an inside and an outside; locating a
hinge about the bulbous tube and in the wall as an area of
preferential bending so the bulbous tube is normally flipped with
the outlet folded about the hinge into the passage, and locating a
seat on the inside of the wall to engage the outlet when the
bulbous tube is flipped into the passage by bending the hinge
acutely so the outlet is moved along the axis toward the inlet and
held against the seat.
15. A method of using a valve including a bulbous tube formed of a
flexible material, the bulbous tube having an inlet fixed across
the orifice and an outlet opposite thereto, the bulbous tube having
a barrel shape tapering toward the inlet and the outlet, a hinge
about the bulbous tube, the hinge as an area of preferential
bending so the bulbous tube is normally flipped with the outlet
folded about the hinge so a seat within the bulbous tube seals the
outlet, the method of using with the steps of: flipping the bulbous
tube by bending the hinge acutely so the outlet is moved toward the
inlet and held against the seat.
16. The method of claim 15 with the steps of unfolding the acutely
bent hinge and locating a flange with a generally flat ring shape
around the inlet of the bulbous tube to interface about the
orifice;
17. The method of claim 15 with the step of unfolding the acutely
bent hinge by pressurizing the seat at the inlet but within the
bulbous tube to unseal the outlet.
18. The method of claim 15 with the step of unfolding the acutely
bent hinge by pressing about the hinge to flip the outlet away from
the seat.
Description
FIELD OF INVENTION
[0001] This invention relates to a valve for alleviating urinary
incontinence. More particularly, the invention is concerned with a
patient controlled valve to permit urination and prevent
undesirable leakage of urine while allowing relief when needed
without removal of the valve from the body of the patient. A most
preferred embodiment of the device is for alleviating urinary
incontinence, particularly stress incontinence, in a female
patient.
BACKGROUND OF THE INVENTION
[0002] Urinary incontinence, which is a condition involving
involuntary loss of urine, is a problem with many patients,
particularly females, throughout the world. Sometimes the problem
is treated with surgery or incontinence pads. Some patients can not
receive surgery or suffers only from a partial loss of urine. Those
problems may be treated non-surgically by use of internal
(intra-urethral or intra-vaginal) or external devices. A number of
external female devices have been patented.
[0003] For example, U.S. Pat. No. 5,074,855 discloses a device for
controlling urinary incontinence in a human female including a
resilient pad configured to seal against and occlude the urethral
meatus of the user. A similar device is disclosed in U.S. Pat. No.
5,336,208. In those devices, an adhesive is provided to seal the
body of the device against the urethral meatus.
[0004] International Applications No. 96/39989, 96/39990 and
96/39991 each disclose a female urinary incontinence device in the
form of an urethral cap with a partially deformable body portion, a
hand gripping portion and a body contacting surface. The body
portion defines a chamber which allows for a vacuum seal when
applied to the patient's body.
[0005] Each of the above devices prevents urinary leakage by
occluding the external urethral orifice and each has to be removed
by the patient to allow micturition.
[0006] It is desirable to have a device which satisfactorily
prevents leakage and also facilitates relief without the need to
remove the device from the body of the patient. It has now been
found that these benefits may be achieved with an easily operable
valve which prevents leakage when closed and allows flow when
open.
SUMMARY OF THE INVENTION
[0007] A valve adapted for closing a body orifice most preferably
has a bulbous tube formed of a flexible material as its main
structure and shape. The bulbous tube may have an inlet fixed
across the body orifice and an outlet positioned away from the body
orifice for controlling incontinence. A flange located around the
inlet of the bulbous tube is used in the preferred embodiment to
attach to the body. The flange most preferably has a generally flat
ring shaped configuration to circumscribe the inlet and to
interface about the body orifice. A passage is formed within and
passes through the bulbous tube for extending from the inlet along
an axis therethrough between the inlet and outlet. A wall of the
bulbous tube is preferably integral therewith. The wall may be
located between the inlet and the outlet. Consistent with the
configuration the wall may have a barrel shape tapering toward the
inlet and the outlet so the bulbous tube is most preferably wider
therebetween. The wall can be between an inside and an outside.
[0008] A hinge is preferably part of the wall and about the bulbous
tube. The hinge might be located in the wall substantially wherein
the barrel shape wall defines the passage therethrough. The hinge
may exist as an area of preferential bending so the bulbous tube is
either normally barrel shaped or flipped with the outlet thereof
folded about the hinge and into the passage. While the preferred
hinge is, that is either open or closed, the hinge can also be
arranged to be normally closed such that to keep it open the outlet
must be pulled away from the seat by the user or the pressure of
urination force from the bladder down the urethra holding the
outlet away from the seat. This can be considered a monostable
arrangement for the hinge but the valve would look the same since
the bias of the hinge is not really apparent in illustrations.
[0009] A seat is preferably positioned within the bulbous tube. The
seat can be in the preferred embodiment located on the inside of
the wall. The seat may perhaps be disposed within the passage to
engage the outlet when the bulbous tube is flipped into the passage
after bending the hinge acutely. The outlet is most preferably then
moved along the axis toward the inlet so the outlet may be held
against the seat to seal the inlet and close the passage.
[0010] One or more holes are preferably dispose through the wall.
Each hole might be located in a plane substantially normal to the
axis and away from the inlet and axially beyond the hinge. The
outlet may surround a bottom of the bulbous tube so that when the
flipped bulbous tube moves the bottom axially into the passage, the
bottom locates the one or more holes dispose through the wall in
contact with the seat and positions the bottom to close the
inlet.
[0011] The outlet in an alternate embodiment most preferably
includes a plug supported from the wall and within the outlet by a
web so that when the flipped bulbous tube moves the plug axially
through the passage. In that alternate configuration the plug
contacts the seat and closes the inlet.
[0012] The wall about the inlet may in this version includes a pipe
depending therefrom and into the passage so the seat is most
preferably on the pipe away from the inlet. The seat on the pipe
can be adapted to engage the plug for remotely closing the inlet.
The inlet might include a duct positioned thereabout to surround
the inlet and extend the passage away from the outlet, the duct,
the flange and the bulbous tube are thus in this arrangement
adapted for fluid communication with the body orifice.
[0013] The bulbous tube is preferred to be circular in cross
section and substantially symmetrical about the axis and the inlet
and outlet are substantially normal to the axis but need not be
symmetric or circular. The bulbous tube could be formed of a
flexible polymer by for example molding or casting. The outlet most
preferably includes a grip projecting therefrom for use in pulling
the outlet to flip the hinge and open the passage between the inlet
and outlet.
[0014] A method of making a valve adapted for closing an orifice
may include steps. Forming a bulbous tube of a flexible material
may be a step. The step of having on the bulbous tube an inlet
fixed for placement across the orifice and an outlet positioned
away from the orifice is a step. The step of locating a flange with
a generally flat ring shape around the inlet of the bulbous tube to
interface about the orifice is preferably performed. Extending a
passage within the bulbous tube from the inlet along an axis
therethrough may be a preferred step. It is most preferred that
having a barrel shaped wall on the bulbous tube with the wall
tapering toward the inlet and the outlet and thus wider
therebetween is a step. The wall between an inside and an
outside.
[0015] Locating a hinge about the bulbous tube and in the wall as
an area of preferential bending so the bulbous tube is either
normally barrel shaped or flipped with the outlet folded about the
hinge into the passage may be a step. The step of locating a seat
on the inside of the wall to engage the outlet when the bulbous
tube is flipped into the passage by bending the hinge acutely so
the outlet is moved along the axis toward the inlet and held
against the seat is in the method.
[0016] A method of using a valve may include the bulbous tube
formed of a flexible material. The bulbous tube preferably has an
inlet fixed across the orifice and an outlet opposite thereto. The
bulbous tube has a barrel shape tapering toward the inlet and the
outlet so the hinge about the bulbous tube. The hinge is an area of
preferential bending so the bulbous tube is either normally barrel
shaped or flipped with the outlet folded about the hinge. A seat
within the bulbous tube seals the outlet. The method of using with
the steps of flipping the bulbous tube by bending the hinge acutely
so the outlet is moved toward the inlet and held against the seat.
The method of using with the step of unfolding the acutely bent
hinge. The method of using with the step of unfolding the acutely
bent hinge by pressurizing the seat at the inlet but within the
bulbous tube to unseal the outlet. The method of using with the
step of unfolding the acutely bent hinge by pressing about the
hinge to flip the outlet away from the seat.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a view in perspective of the valve adapted for
closing a body orifice (not shown) wherein the valve is shown in
its open position.
[0018] FIG. 2 is a view in cross section of the valve as would be
seen along line 2-2 of FIG. 1.
[0019] FIG. 3 is a view in cross section of the valve similar to
that of FIG. 2 but wherein therein the valve is shown flipped over
center with respect to the hinge in its valve closed position.
[0020] FIG. 4 is a view in perspective of an alternate valve
adapted for closing a body orifice (not shown) wherein the
alternate valve is shown in its open position.
[0021] FIG. 5 is a view in cross section of the alternate valve as
would be seen along line 5-5 of FIG. 4.
[0022] FIG. 6 is a view in cross section of the alternate valve
similar to that of FIG. 5 but wherein therein the alternate valve
is shown flipped over center with respect to the hinge in its
alternate valve closed position.
[0023] FIG. 7 is a view in perspective of an alternative valve
adapted for closing a body orifice (not shown) wherein the
alternate valve is shown in its open position.
[0024] FIG. 8 is a view in cross section of the alternative valve
as would be seen along line 8-8 of FIG. 7.
[0025] FIG. 9 is a view in cross section of the alternative valve
similar to that of FIG. 8 but wherein therein the alternative valve
is shown flipped over center with respect to the hinge in its
alternative valve closed position.
DETAILED DESCRIPTION OF THE DRAWINGS
[0026] A valve 10 adapted for closing a body orifice (not shown)
has a bulbous tube 11 formed of a flexible material as its main
structure and shape. The bulbous tube 11 is preferably molded as
one integral component but can be cast integrally or assembled from
separately made parts, see FIGS. 1, 2, 3, 4, 5, 6, and 7. The
bulbous tube 11 has an inlet 12 that is fixed across the body
orifice and an outlet 13 positioned away from the body orifice for
controlling incontinence. The outlet 13 is open when the valve 10
is unseated as will be understood upon a complete reading of this
disclosure. The body orifice may be the female meatus and its
passageway, the urethra, for urine (not shown in the figures). A
flange 14 located around the inlet 12 of the bulbous tube 11 is
used in the preferred embodiment to attach to the body with a
medical grade adhesive such as a moisture effusing acrylic. Skilled
artisans would know the proper adhesive to accommodate bodily
fluids without disconnection or leakage and to minimize irritation.
The flange 14 most preferably has a generally flat ring shaped
configuration to circumscribe the inlet 12 and to interface about
the body orifice see FIGS. 1, 2, 3, 4, 5, 6 and 7.
[0027] A passage 15 is formed within and passes through the bulbous
tube 11 for extending from the inlet 12 along an axis A-A
therethrough between the inlet 12 and outlet 13. A wall 16, in
FIGS. 3, 5, 6 and 8, of the bulbous tube 11 is preferably integral
therewith. The wall 16 is in the preferred embodiment located
between the inlet 12 and the outlet 13. Consistent with the
configuration of the bulbous tube 11 the wall 16 is about 0.5 mm
and has a barrel shape 17 as shown in FIGS. 2, 5 and 8. The barrel
shape 17 tapers toward the inlet 12 and the outlet 13 so the
bulbous tube 11 is wider therebetween. Similarly, the passage 15
through the bulbous tube 11 is wider between the inlet 12 and the
outlet 13. The wall 16 is between an inside 18 and an outside 19 as
seen the view in cross section of FIGS. 3, 5, 6 and 8. The
preferred wall 16 is about 0.5 mm thick but the particular
thickness is more a function of the durometer of the flexible
polymer. The preferred polymer is C-Flex TPE Thermoplastic made by
Consolidated Polymer Technologies, Inc. of Largo, Fla. C-Flex
polymer has an 18 shore A durometer and the preferred wall 16
thickness of 0.5 mm; the valve 10 seating force is 15 grams and the
over center force is about 50 grams. Of course the forces are a
balance between the force to hold the valve 10 closed and the
adhesive connection about the body orifice.
[0028] A hinge 20 is an integral part of the wall 16 and runs about
the bulbous tube 11. The hinge 20 is preferred to be located
axially in the wall 16 substantially wherein the barrel shape 17
wall 16 defines the passage 15 therethrough; that is at the widest
part of the bulbous tube 11. The hinge 20 acts as an area of
preferential bending at the barrel shape 17 so the bulbous tube 11
is either normally barrel shaped 17, in FIGS. 1, 2, 4, 5, 7 and 8,
or flipped with the outlet 13 thereof folded about the hinge 20 and
into the passage 15 in FIGS. 3 and 6. The force to flip the hinge
20 has been measured in the range of about 10 to 100 grams but
preferably 15 grams as explained. While the preferred hinge 20 is,
that is either open or closed, the hinge 20 can also be arranged to
be normally closed such that to keep it open the outlet 13 must be
pulled away from a seat 21 by the user or the pressure of urination
force from the bladder down the urethra may be applied for holding
the outlet 13 away from the seat 21. This form of hinge 20
operation can be considered monostable but the valve 10 would look
the same since the bias of the hinge 20 is not really apparent in
illustrations. Consequently, as used herein the term, "bistable"
includes normally open or closed valves 10 or alternatively
normally closed valves 10 as explained.
[0029] Seat 21 is positioned within the bulbous tube 11 on the
inside 18 of the wall 16. The seat 21 is be disposed within the
passage 15 to engage the outlet 13 when the bulbous tube 11 is
flipped into the passage 15 after bending the hinge 20 acutely. The
outlet 13 is then moved along the axis A-A toward the inlet 12 so
the outlet 13 is held against the seat 21 to seal the inlet 12 and
close the passage 15. The seat 21 is axially between the inlet 12
and the wide part of the barrel shape 17 of the bulbous tube 11,
see FIGS. 2, 5 and 8.
[0030] One or more holes 22 are preferably dispose through the wall
22. Each hole 22 might be located in a plane substantially normal
to the axis and away from the inlet 12 and axially beyond the hinge
20. In one preferred alternative the outlet 13 may surround a
bottom 23 of the bulbous tube 11 so that when flipped bulbous tube
11 moves the bottom 23 axially into the passage 15. The bottom 23
in FIGS. 1, 2 and 3 locates the one or more holes 22 dispose
through the wall 16 in contact with the seat 21 and positions the
bottom 23 to close the inlet 12; this is best shown in the view in
cross section of FIGS. 1, 2, 4, 5, 7 and 8.
[0031] The outlet 13 in another alternate embodiment of FIGS. 4, 5
and 6 includes a plug 24 supported from the wall 16 and within the
outlet 13 by a web 25 so that when the flipped bulbous tube 11
moves the plug 24 axially through the passage 15 the plug 24 seats;
this is best shown in the view in cross section of FIG. 5 and 6. In
that alternate configuration the plug 24 contacts the seat 21 and
closes the inlet 12. The wall 16 about the inlet 12 may in this
version include a pipe 26 depending at the wall 16 inside 18
thereabout. The pipe 26 in FIGS. 5 and 6 is thus in the passage 15
so the seat 21 is most preferably on the pipe 26 away from the
inlet 12. Consequently, the seat 21 and the pipe 26 can be adapted
to engage remotely, or axially along the passage 15, closing the
inlet 12.
[0032] Similarly in another alternative, the inlet 12 might include
a duct 27 positioned thereabout to surround the inlet 12 and extend
passage 15 away from the outlet 13. The duct 27, the flange 14 and
the bulbous tube 11 are thus in that arrangement adapted for fluid
communication with the body orifice. The duct 27 extends into the
urethra (not shown) may have a gel 28 in FIG. 8 about it to protect
the patient's body, help the fit therein and ease insertion.
[0033] The bulbous tube 11 is preferred to be circular in cross
section as shown in all the Figures and substantially symmetrical
about the axis A-A as shown in the preferred valves 10. The
preferred inlet 12 and outlet 13 are substantially normal to the
axis A-A but need not be symmetric or circular. The bulbous tube 11
is formed of a flexible polymer by molding. The outlet 13 may have
a grip 29 in FIGS. 2, 3, 4, 5 and 6 projecting therefrom for use in
pulling the outlet 13 to flip the hinge 20 and open the passage 15
between the inlet 12 and outlet 13.
[0034] A method of making valve 10 adapted for closing an orifice
includes steps. Forming bulbous tube 11 of a flexible material is a
step. The step of having on the bulbous tube 11 inlet 12 fixed for
placement across the orifice and outlet 13 positioned away from the
orifice is a step. The step of locating flange 14 with a generally
flat ring shape around the inlet 12 of the bulbous tube 11 to
interface about the orifice is performed in this method. Extending
passage 15 within and through the bulbous tube 11 from the inlet 12
along axis A-A therethrough is a step. Having barrel shaped 17 wall
16 on the bulbous tube 11 with the wall 16 tapering toward the
inlet 12 and the outlet 13 and thus wider therebetween is a step.
Locating the wall 16 between inside 18 and outside 19 is a
step.
[0035] Locating hinge 20 about the bulbous tube 11 and in the wall
16 as an area of preferential bending so the bulbous tube 11 is
either normally barrel shaped 17 or flipped with the outlet 13
folded about the hinge 20 into the passage 15 is a step.
Preferentially bending the hinge 20 is a step. The step of locating
seat 21 on the inside 18 of the wall 16 to engage the outlet 13
when the bulbous tube 11 is flipped into the passage 15 by bending
the hinge 20 acutely so the outlet 13 is moved along the axis A-A
toward the inlet 12 and held against the seat 21 is in the
method.
[0036] A method of using the valve 10 has the bulbous tube 11
formed of a flexible material. The bulbous tube 11 has the inlet 12
fixed across the orifice and outlet 13 opposite thereto. The
bulbous tube 11 has barrel shape 17 tapering toward the inlet 12
and the outlet 13 so the hinge 20 is about the bulbous tube 11. The
hinge 20 is an area of preferential bending. The bulbous tube 11 is
either normally barrel shaped 17 or flipped with the outlet 13
folded about the hinge 20 so seat 21 within the bulbous tube 11
seals the outlet 13. The method of using with the step of flipping
the bulbous tube 11 by bending the hinge 20 acutely moves the
outlet 13 toward the inlet 12 for holding against the seat 21. The
method of using with the step of unfolding the acutely bent hinge
20 by acutely bending hinge 20 by pressurizing the seat 21 at the
inlet 12 but within the bulbous tube 11 to unseal the outlet 13 or
by pressing about the hinge 20 to flip the outlet 13 away from the
seat 21.
[0037] While several embodiments have been shown and described, the
valve 10 sought to be protected by the claims that follow has the
outlet 13 that seats or is unrestricted excepted when seated.
* * * * *