U.S. patent number RE31,121 [Application Number 06/176,546] was granted by the patent office on 1983-01-11 for control device for prosthetic urinary sphincter cuff.
This patent grant is currently assigned to Parker-Hannifin Corporation. Invention is credited to Robert H. Reinicke.
United States Patent |
RE31,121 |
Reinicke |
January 11, 1983 |
Control device for prosthetic urinary sphincter cuff
Abstract
A device for controlling flow of fluid to and from a resilient
inflatable cuff implanted about the urethra to control flow of
urine therethrough. The device comprises a flexible bulb reservoir
and a control unit that includes a manually operated valve that
opens automatically when the bulb is squeezed to force fluid into
the cuff for closing the urethra. The control unit also includes a
movable valve seat member having a relatively large area exposed to
pressure of fluid in a chamber that is connected to the cuff and
which moves to a position in which the valve member is unseated by
an abutment when fluid pressure in the chamber exceeds a
predetermined value to thereby relieve excess fluid pressure in the
cuff. The arrangement is such that the valve element is held closed
against the seat member by the full differential in fluid pressures
acting on both sides of the valve element until the seat member is
moved away from the valve element to thus insure positive closing
of the valve element until the seat member is moved out of
engagement with the valve element by excess pressure
differential.
Inventors: |
Reinicke; Robert H. (Mission
Viejo, CA) |
Assignee: |
Parker-Hannifin Corporation
(Cleveland, OH)
|
Family
ID: |
26872349 |
Appl.
No.: |
06/176,546 |
Filed: |
August 8, 1980 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
Reissue of: |
884864 |
Mar 9, 1978 |
04167952 |
Sep 18, 1978 |
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Current U.S.
Class: |
137/493;
128/DIG.25; 623/66.1 |
Current CPC
Class: |
A61F
2/004 (20130101); Y10T 137/7771 (20150401) |
Current International
Class: |
A61F
2/00 (20060101); F16K 017/18 (); A61B 017/00 ();
A61F 001/00 () |
Field of
Search: |
;128/1R,346,DIG.25 ;3/1
;137/493,522 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Maky, Renner, Otto &
Boisselle
Government Interests
BACKGROUND OF THE INVENTION .Iadd.
The invention described herein was made in the performance of work
under NASA Contract No. NAS 8-32970 and is subject to the
provisions of section 305 of the National Aeronautics and Space Act
of 1958 (72 Stat. 435; 42 U.S.C. 2457). .Iaddend.
Claims
I claim:
1. A device useful with a prosthetic .[.urinary sphincter valve.].
.Iadd.inflatable implant .Iaddend.for controlling flow of fluid
from a reservoir to a receiver, said device comprising an envelope
with a movable wall portion and which envelope is closed except for
a first duct connectable to the reservoir and a second duct
connectable to the receiver, a control unit in said envelope, said
unit including a valve element and a ported seat member for
controlling flow of fluid between said ducts, said seat member
being spring pressed to a first position in which said valve
element may be spring pressed into engagement .Iadd.with
.Iaddend.the seat member for closing the port therein, manually
operable means for moving the seat member to a second position,
means to prevent the valve element from seating on the seat member
when the seat member is in said second position whereby the port in
the seat member will be open, and said seat member having an
effective area subject to pressure of fluid in said second duct and
movable thereby to said second position.
2. The device of claim 1 in which the control unit includes an
abutment engageable with the valve element when the seat member is
in the second position.
3. The device of claim 1 in which the force of the spring for the
seat member is greater than that of the spring for the valve member
and acts in opposition thereto.
4. The device in claim 1 in which the seat member comprises a
diaphragm having a flexible peripheral portion sealingly attached
to the control unit and a relatively inflexible portion through
which said port extends.
5. A device useful with a prosthetic .[.urinary sphincter valve.].
.Iadd.inflatable implant .Iaddend.for controlling flow of fluid to
and from a receiver, comprising a reservoir for fluid, a flexible
cover and a control unit, said unit including a housing having a
sealed connection to the cover to form a chamber therebetween, a
duct leading from said chamber for connection to the receiver, the
housing having an abutment and having a cavity and carrying a
movable valve seat member that separates the cavity from the
chamber, a port through the member for connecting the cavity to the
chamber, a valve element, a first spring urging the valve element
into engagement with the member for closing the port, a second
spring urging the member to a first position in which the valve
element is out of engagement with said abutment and in its port
closing position, manually operable plunger for moving the seat
member to a second position in which the abutment engages the valve
element for opening said port, and said seat member having an area
exposed to fluid in said chamber and movable thereby to its second
position when the pressure of fluid in said chamber exceeds a
predetermined value.
6. The device of claim 5 in which there is a stop to limit movement
of the seat member in the direction toward its first position.
7. The device of claim 5 in which there is a stop to limit movement
of the plunger in the direction toward said second position.
8. The device of claim 5 in which the seat member comprises a
flexible diaphragm.
9. The device of claim 8 in which the diaphragm has a relatively
thick central portion through which said port extends and a
relatively thin and readily flexible peripheral portion.
10. The device of claim 9 in which said second spring bears against
said central portion.
11. The device of claim 9 in which said plunger is engageable with
said central portion.
12. The device of claim 5 in which said plunger has a bore and said
valve element is within said bore.
13. The device of claim 5 in which said abutment projects into said
port when the seat member is in said second position.
14. The device of claim 6 in which said stop comprises engagement
of a portion of the plunger with a portion of said housing.
15. The device of claim 7 in which said stop comprises engagement
of a portion of the plunger with a portion of said housing.
16. The device of claim 5 in which said valve element has an
effective area subject to pressure fluid in said chamber for urging
the valve element against the seat member for closing said port
when the member is in said first position.
17. The device of claim 5 in which said plunger has a recess at one
end thereof, said valve element is in said recess, said one end
engages the seat member, and said plunger has a flange engageable
with a shoulder on said housing to limit movement of the plunger in
the direction of said first position. .Iadd. 18. A device useful
with a prosthetic inflatable implant for controlling flow of fluid
from a reservoir to a receiver, said device comprising an envelope
with a movable wall portion and which envelope is closed except for
a first duct connectable to the reservoir and a second duct
connectable to the receiver, a control unit in said envelope, said
unit including a valve element and a ported seat member for
controlling flow of fluid between said ducts, said seat member
being spring pressed to a first position in which said valve
element may be spring pressed into engagement with said seat member
for closing the port therein, said valve element including an
effective area subject to pressure of fluid in said first duct and
movable thereby away from said seat member, manually operable means
for moving said seat member to a second position, means to prevent
said valve element from seating on said seat member when said seat
member is in such second position whereby the port in seat said
member will be open, and said seat member having an effective area
subject to pressure of fluid in said second duct and movable
thereby to such second position. .Iaddend..Iadd. 19. A device
useful with a prosthetic inflatable implant for controlling flow of
fluid from a reservoir to a receiver, said device comprising an
envelope with a movable wall portion and a control unit in said
envelope, said envelope having a first duct connectable to the
reservoir and a second duct connectable to the receiver, and said
control unit including a movable valve element and a movable ported
valve seat member for controlling flow of fluid between said ducts,
spring means for urging said seat member to a first position in
which said valve element normally may be spring pressed into
engagement with said seat member for closing the port therein, said
valve element including an effective area subject to pressure of
fluid in said first duct and movable thereby away from said seat
member, means adapted to extend through said port into engagement
with said valve element for unseating said valve element to open
the port, said seat member having an effective area subject to
pressure of fluid in said second duct and movable thereby from said
first position to a second position in which said means for
unseating extends through the port to unseat said valve element,
and means responsive to movement of said movable wall portion for
effecting relative movement of said seat member and means for
unseating to a positional relationship in which said means for
unseating extends through the port to unseat said valve element.
.Iaddend. .Iadd. 20. A device useful with a prosthetic inflatable
implant for controlling flow of fluid from a reservoir to a
receiver, said device comprising an envelope with a movable wall
portion and a control unit in said envelope, said envelope having a
first duct connectable to the reservoir and a second duct
connectable to the receiver, and said control unit including a
housing having an abutment and a cavity therein, a movable valve
seat member in said housing dividing said cavity into first and
second chambers, means connecting said first and second chambers
respectively to said first and second ducts, said seat member
having port means therein for connecting said first and second
chambers, a valve element, first biasing means urging said valve
element into engagement with said seat member for closing said port
means, said valve element including an effective area subject to
pressure of fluid in said first chamber and movable thereby against
said first biasing means away from said seat member to open said
port means, second biasing means for urging said seat member to a
first position in which said valve element normally is out of
engagement with said abutment, said seat member having an area
exposed to fluid in said second chamber and movable thereby against
said second biasing means to a second position in which said
abutment engages said valve element to unseat same for opening said
port means when the pressure of fluid in said second duct exceeds a
predetermined value, and means responsive to said movable wall
portion for unseating said valve element to open said port means
independently of the fluid pressure level in said first and second
chambers. .Iaddend..Iadd. 21. The device of claim 20 in which said
means for unseating includes manually operable means for effecting
relative movement of said seat member and abutment to a positional
relationship in which said abutment engages said valve element to
open said port means. .Iaddend..Iadd. 22. The device of claim 21 in
which there are spring means for urging said valve seat and means
for unseating out of such positional relationship. .Iaddend..Iadd.
23. The device of claim 19 or 20 in which the effective area of
said seat member is greater than that of said valve element.
.Iaddend..Iadd. 24. A device for controlling flow of fluid to and
from a prosthetic inflatable implant, comprising a reservoir, an
outlet duct connectable to the inflatable implant, and control
means for controlling flow of fluid between said reservoir and
outlet duct, said control means including passage means connecting
said reservoir and outlet duct, first means for normally closing
said passage means, said first means having an effective area
subject to pressure of fluid in said reservoir and movable thereby
for opening said passage means, second means having an effective
area greater than that of said first means subject to pressure of
fluid in said outlet duct and movable thereby from a first position
for permitting said first means to close said passage means to a
second position for preventing said first means to close said
passage means when the pressure of fluid in said outlet duct
exceeds a predetermined valve, and manually actuable means for
moving said second means to its second position. .Iaddend..Iadd.
25. The device of claim 22 in which said second means includes a
diaphragm. .Iaddend..Iadd. 26. The device of claim 22 in which
there is an envelope for said control means, said envelope having a
movable wall portion and said manually actuable means being
responsive to manual movement of said movable wall portion.
.Iaddend..Iadd. 27. The device of claim 22 in which said first
means when closed further has an effective area subject to pressure
in said outlet duct and is arranged such that said first means
normally is held closed by the full fluid pressure differential
between said reservoir and outlet duct. .Iaddend.
Description
Various devices have been proposed for implantation in the human
body for opening and closing the urethra when the sphincter muscle
is unable to perform this function. Some of such devices are shown
in U.S. Pat. Nos. 3,744,063, 3,863,622, 3,854,469, 3,903,894, and
4,019,499. They include a resilient inflatable cuff or other member
that is implanted to surround the urethra and which when inflated
by a fluid squeezes the urethra closed and when deflated permits
the urethra to open.
In one such prior device as yet unpublished there is a bulb of
flexible material that comprises a reservoir for the fluid and a
valved control unit to control flow of fluid in both directions
between the cuff and reservoir. The control unit includes a spring
seated valve element that may be unseated by an abutment through
manual operations to permit flow of fluid from the cuff to the
reservoir and wherein the valve seat is movable by pressure of
fluid within the reservoir to a position away from the valve
element when the valve element is against the abutment to permit
flow of fluid to the cuff. The valve element is also unseatable by
excess fluid pressure in the cuff to thus act as a pressure relief
valve. However, the arrangement is such that the spring force for
seating the valve element is gradually overcome by the increasing
differential in fluid pressure between the cuff and reservoir so
that there is a diminishing seating force on the valve element as
the relief pressure is approached. This results in less assurance
that the valve will remain closed prior to the time that excess
pressure in the cuff is experienced and hence leakage across the
valve and opening of the urethra may occur at inconvenient
times.
SUMMARY OF THE INVENTION
The present invention is an improvement in the prior device
described above in that not only does the spring for closing the
valve element exert its full force for maintaining the valve
element closed prior to the time that excess pressure is developed
in the cuff, but in addition the fluid pressure differential
between the cuff and reservoir when the cuff pressure is greater
than that in the reservoir supplements the spring pressure in
maintaining the valve element closed until the pressure in the cuff
exceeds a predetermined value.
This is accomplished by arranging the valve element so that it will
be openable against pressure of its spring by pressure of fluid
from the reservoir and seatable by pressure of fluid in the cuff,
and by providing a movable seat member which has a relatively large
area exposed to pressure of fluid from the cuff to move the seat
member away from the valve element when the fluid pressure in the
cuff is excessive and following movement of the valve element with
the movable member is prevented by engagement of the valve element
with an abutment.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a view of the device as implanted in a human body.
FIG. 2 is a view of the cuff.
FIG. 3 is a cross-section view of the device in its normally closed
position for trapping fluid under pressure in the cuff as when the
latter is inflated for closing the urethra.
FIG. 4 is a cross-section view of the device when manually actuated
for deflating the cuff to open the urethra.
FIG. 5 is a fragmentary cross-section view showing the valve
element in open position due to squeezing of the flexible
reservoir.
FIG. 6 is a fragmentary cross-section view showing the seat member
when automatically moved away from the valve element to relieve
excess pressure in the cuff.
As shown in FIG. 1, the device 10 of the present invention is
connected by a tube 11 to an inflatable cuff 12. All these parts
are implanted surgically into a human body. Cuff 12 is a hollow
donut shaped member of resilient flexible material such as a
silicone elastomer and surrounds the urethra 13. Device 10 is
preferably implanted within the scrotum of male patients where it
is readily accessible for digital manipulation or it may be
implanted at other locations in the body where it may be actuated
by externally applied pressure.
Device 10 has a housing 16 that comprises a body 17 of nylon or
other material and a ring 18 of nylon or the like that clamps a
flexible diaphragm 20 at its outer margin 21 against a shoulder 22
on body 17. Ring 18 is retained by an inwardly crimped tubular
extension 23 on body 17. Housing 16 has a cavity 26 with a duct 27
leading therefrom and also has an upwardly projecting abutment
28.
Cemented to tubular extension 23 is a cover 31 of flexible sheet
material, such as silicone elastomer. Cover 31 is also cemented to
another cover portion 32 of like material and which is also
cemented to body 17, at least around the open end portion 33 of
cover 32. A bulb shaped reservoir 35 of like flexible sheet
material is cemented to cover portions 31, 32 as shown at 36,37. An
opening 38 in cover portion 31 permits free communication between
duct 27 and the interior of reservoir 35.
Diaphragm 20, which may also be made of a silicone elastomer, has a
thin flexible peripheral portion 41 and a relatively thick
non-flexible central portion 42 with an opening 43 therethrough. A
spring 46 urges diaphragm central portion 42 upwardly and there are
washers 47,48 between the spring and diaphragm portion 42 and body
17.
The interior of cover 31 forms a chamber 51 which communicates with
a tubular member 52 which is cemented to a short tubular projection
53 on cover 31 and to which tube 11 is to be connected.
Mounted on housing 16 within chamber 51 is a plunger 56 comprised
of a tubular member 57 having a bore 58, a side opening 59 and a
flange 62 that has a series of circumferentially spaced holes 63
therethrough. Flange 62 overlaps shoulder 64 on ring 18 so that
shoulder 64 acts as a stop to limit upward movement of plunger 56.
Plunger 56 also includes a button 66 pinned to member 57 at 67 and
whose lower face has radial grooves 68. Button 66 radially overlaps
ring 18 to abut the latter for limiting downward movement of the
plunger 56. Within bore 58 is a ball valve element 70 pressed by a
relatively light spring 71 toward a seated position on diaphragm
central portion 42 to control flow of fluid through port 43. Spring
46 is stronger than spring 71 so that diaphragm 20 central portion
42 is normally maintained against tubular member 57 and the latter
in its upward position with flange 62 against shoulder 64.
OPERATION
During or before implantation, device 10 is completely filled with
a liquid, such as a saline solution, so that reservoir 35 and all
the spaces within housing 16, plunger 56 and chamber 51 are filled
but not under pressure. Likewise tube 11 and cuff 12 are filled
with the liquid but not under pressure. At this time the parts of
device 10 are in the position shown in FIG. 3 with valve element 70
seated against diaphragm central portion 42, the latter against
plunger member 57 and with flange 62 against shoulder 64. Cuff 12
will be deflated, that is, full of liquid that is not under
pressure, so that urethra 18 will be open.
To close the urethra, reservoir 35 is squeezed by digital
manipulation to pressurize the liquid therein and force a portion
thereof through duct 27 and cavity 26 to port 43 where it forces
valve element 70 off its seat as in FIG. 5, and passes through bore
58, opening 59, chamber 51 and tube 11 to inflate cuff 12 for
closing the urethra. Upon release of reservoir 35 and the
consequent drop of pressure therein, valve element 70 will reseat
to close opening 43 to trap pressurized liquid within bore 58,
chamber 51, tube 11 and cuff 12 so that the latter remains inflated
and the urethra closed.
To open the urethra, digital pressure is applied to covers 31,32 on
vertical opposite sides of the device until cover 31 engages the
upper surface of button 66. Plunger 56 is moved downward until the
button engages ring 18, as in FIG. 4. In this position, projecting
abutment 28 will have engaged valve element 70 to unseat the latter
and permit fluid under pressure from above the valve element to
flow through port 13 to the unpressurized cavity 26 and reservoir
35 to thus deflate cuff 12 and permit the urethra to open. Upon
such release of pressure above valve element 70 the latter will
again close. To reclose the urethra, digital pressure is again
applied to the reservoir for inflating the cuff as already
described.
In case too much digital pressure is applied to the reservoir,
either intentionally or accidentally, excessive liquid pressure may
be transmitted to the cuff. Upon release of the reservoir such
excess pressure will be relieved by action of diaphragm 20. Thus,
upon release of the reservoir, valve element 70 will close but the
excess pressure in chamber 51 having access to the upper side of
diaphragm 20 through holes 63 and the interior of bore 58, where it
also acts downwardly on valve element 70, will force the diaphragm
and valve element downwardly. When the valve element strikes
abutment 28 its downward motion ceases but the diaphragm will
continue downwardly so that its central portion 42 moves away from
the valve element to open part 43, as shown in FIG. 6, and permit
downward flow of liquid therethrough until the pressure of liquid
in shoulder 51 and cuff 12 has a predetermined differential or
value with respect to the pressure in reservoir 35 and cavity 26,
as determined by springs 71 and 46. Thereupon spring 46 will raise
diaphragm 20 to reseat against valve element 70 to trap liquid at
the correct pressure in chamber 51 and cuff 12 according to the
predetermined pressure differential.
With the present arrangement of device 10, when valve element 70 is
closed to trap liquid under pressure in cuff 12 and chamber 51,
this pressure which is supplemental by the force of spring 71, acts
downwardly on the valve element across an effective area equal to
the area bounded by its seating contact with diaphragm central
portion 42, which is essentially the cross-section area of port 43
in this case. The full force of this downward fluid and spring
pressure is maintained for keeping the valve element tightly seated
at all times until the valve element is unseated by contact with
abutment 28 either because of manual operation or of pressure
relief action of the diaphragm. Such full force on the valve
element eliminates the possibility of leakage past the valve
element due to reduced seating pressure as occurs in the prior
device described above. Also, because the effective area of the
diaphragm subject to pressure of liquid within chamber 51 and
plunger bore 58 is relatively large the diaphragm will be sensitive
to pressure differentials exceeding the predetermined value and
result in quick opening of part 43 for relieving the excess
pressure in chamber 51 and cuff 12.
Although one specific form of the invention has been illustrated in
the drawings, it is obvious that various modifications may be made
within the scope of the invention as claimed. Thus, for example,
diaphragm 20 could be replaced by a piston of rigid material with
appropriate changes in body 17, tubular member 57 could be in the
form of several rods, and so forth.
* * * * *