U.S. patent number 3,810,259 [Application Number 05/348,644] was granted by the patent office on 1974-05-14 for implantable urinary control apparatus.
This patent grant is currently assigned to Fairchild Industries, Inc.. Invention is credited to George D. Summers.
United States Patent |
3,810,259 |
Summers |
May 14, 1974 |
IMPLANTABLE URINARY CONTROL APPARATUS
Abstract
An implantable urinary control apparatus for controlling the
flow of urine from the bladder including a pump adapted to be
connected to the bladder for pumping urine out of the bladder and
into a natural or artificial channel so that it can be from the
fromthe body. The apparatus also includes a sensor adapted to be
connected to the natural or to an artificial urinary bladder for
detecting the pressure in the bladder as it fills with urine, and
an alarm unit connected to the sensor for giving warning that the
bladder is filling with urine when the sensor detects the pressure
caused by urine in the bladder.
Inventors: |
Summers; George D. (Bethesda,
MD) |
Assignee: |
Fairchild Industries, Inc.
(Germantown, MD)
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Family
ID: |
26806849 |
Appl.
No.: |
05/348,644 |
Filed: |
April 6, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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109308 |
Jan 25, 1971 |
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842921 |
Jul 18, 1969 |
3575158 |
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Current U.S.
Class: |
600/30;
128/DIG.25; 623/14.13 |
Current CPC
Class: |
A61F
2/0036 (20130101); A61F 2/042 (20130101); Y10S
128/25 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61F 2/04 (20060101); A61f
001/24 () |
Field of
Search: |
;3/1,1.1,DIG.2
;128/1R,1.3,1.5,214R,273,419E,DIG.25 ;417/411,420 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"A New Minature Pump for Treatment of Hydrocephalus" by G. D.
Summers et al., Journal of the Association for the Advancement of
Medical Instrumentation, Vol. 2, No. 3, May/June 1967, pages
9-16..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: York; Michael W.
Parent Case Text
This application is a continuation of application, Ser. No.
109,308, filed Jan. 25, 1971, now abandoned, which in turn is a
division of application Ser. No. 842,921, filed July 18, 1969, now
U.S. Pat. No. 3,575,158.
Claims
What is claimed is:
1. An implantable urinary control apparatus for controlling the
discharge of urine from the urinary bladder in a body comprising
implantable pump means for pumping urine from said urinary bladder
out of the body, implantable inlet means connected to said
implantable pump means for connecting said urinary bladder to said
implantable pump means for permitting urine to flow from said
bladder to said implantable pump means, implantable outlet means
connected to said implantable pump means for connecting said
implantable pump means to an artificial or natural body channel
that leads out of the body to permit urine to flow from said
implantable pump means to said artificial or natural body channel,
means capable of being operatively coupled to said implantable pump
means for causing the operation thereof, implantable sensing means
adapted to be operatively associated with said bladder for sensing
pressure in said bladder as said bladder is filling with urine,
implantable alarm means operatively connected to said implantable
sensing means for providing an alarm when said sensing means senses
pressure in said bladder as said bladder is filling with urine, and
implantable power source means operatively connected to said alarm
means for supplying power to said implantable alarm means.
2. The implantable urinary control apparatus of claim 1 wherein
said alarm means comprises a resistive heating element.
3. The implantable urinary control apparatus of claim 1 wherein
said sensing means is connected to said implantable inlet
means.
4. The implantable urinary control apparatus of claim 1 further
comprising implantable recharging means operatively connected to
said implantable power source means and means locatable outside the
body for transmitting energy into the body to cause said
implantable recharging means to recharge said implantable power
source means.
5. The implantable urinary control apparatus of claim 1 further
comprising securing means connected to said sensing means for
securing said sensing means to said urinary bladder.
6. The implantable urinary control apparatus of claim 5 wherein
said securing means comprises a strap.
7. An implantable urinary control apparatus for controlling the
discharge of urine from a body comprising an artificial implantable
urinary bladder, implantable pump means for pumping urine from said
implantable bladder out of the body, implantable inlet means
connected to said implantable pump means and to said implantable
bladder for permitting urine to flow from said implantable bladder
to said implantable pump means, implantable outlet means connected
to said implantable pump means for connecting said implantable pump
means to an artificial or natural body channel that leads out of
the body for permitting urine to flow from said implantable pump
means to said artificial or natural body channel, and means capable
of being operatively coupled to said pump means for operating said
implantable pump means.
Description
This invention relates to an implantable control apparatus, more
particularly, this invention relates to an implantable control
apparatus for controlling the discharge of urine from the urinary
bladder.
The failure to discharge urine from the bladder can cause urine to
back up into the kidneys and this can result in serious medical
consequences such as uremia and infections. Present techniques for
medically relieving the failure of urine to flow from the urinary
bladder through the urethra and to outside the body depend in part
on the cause of failure. In some cases the bladder wall no longer
functions either from failure of the motor nerve pathways leading
to the bladder, from deterioration of the bladder wall or muscle,
or from a neoplastic growth interfering with normal function. In
such cases, the usual medical treatment is to insert a catheter
through the urethra and into the bladder. Flow is then controlled
by opening or closing a portion of the catheter external to the
body. This process leads to infection of the urethra and/or the
urinary bladder in most patients when the catheter is left in place
for more than a few days. Often this infection is difficult to
control or cure with antibiotics, especially when the catheter
remains in the body. Additionally, uric acid crystals and other
matter may form or collect in the catheter, leading to restricting
or stopping fluid flow.
Another cause of failure of urine flow is the inability of the
patient to voluntarily cause the sphincters (constricting muscles)
around the urethra to relax. Again in this case a catheter may be
used. A more recent technique has been tried which consists of an
implanted electrical stimulator attached to the sphincters or their
afferent nerves. Powered and controlled in one of several ways, the
electrical current supplied can cause sphincter relaxation.
However, the system has not always proved useful over a period of
time as the sphincters require increasingly large values of current
and/or voltage. Finally a point may be reached when either pain or
burn will occur before sphincter relaxation.
In cases of urinary incontinence in which there is continuous or
intermittent involuntary voiding of urine, present management
techniques include wearing of absorbent diaper-like clothing and
the collection of urine in watertight bags. Unfortunately, these
techniques are inconvenient to use and can cause considerable
discomfort to the patient.
Reference is made to the device described in my co-pending
application Ser. No. 814,760 filed Apr. 9, 1969, now U.S. Pat. No.
3,672,352, which describes the use of implantable sensors for
detecting body conditions in connection with implantable signal
means and means for transmitting energy into the body and receiving
signals from inside the body.
It is therefore an object of the present invention to provide an
implantable urinary control apparatus for controlling the discharge
of urine from the urinary bladder.
Another object of this invention is to provide an implantable
urinary control apparatus that is capable of detecting the pressure
in the urinary bladder caused by the filling of the bladder with
urine.
Another object of the present invention is to provide an
implantable urinary control apparatus that is capable of giving a
warning when the bladder is filling with urine.
Another object of the present invention is to provide an
implantable urinary control apparatus having a pump that is capable
of being powered and controlled from outside the body.
The present invention provides an implantable urinary control
apparatus for controlling the discharge of urine from the urinary
bladder in a body which includes implantable pump means for pumping
urine from the bladder out of the body, implantable inlet means
connected to the implantable pump means for connecting the bladder
to the implantable pump means for permitting urine to flow from the
bladder to the implantable pump means and implantable outlet means
connected to the implantable pump means for connecting the
implantable pump means to an artificial or natural body channel
that leads out of the body for permitting urine to flow from the
implantable pump means to the artificial or natural body channel.
Means capable of being operatively coupled to the pump means for
operating the pump means, implantable sensing and alarm means, and
a power source for the alarm means are also provided.
In order that the invention may be more clearly set forth and
better understood, reference is made to the accompanying drawings
in which:
FIG. 1 is a diagramatic view showing typically how the invention
would be implanted within the body of a human;
FIG. 2 is a diagramatic view of an alternative embodiment of the
invention implanted within the body of a human; and
FIG. 3 is a circuit diagram of the alarm unit, battery and charging
circuit used in the preferred embodiment of the invention.
Referring first to FIG. 1, there is shown a bladder 10 connected to
the kidneys 11. The bladder 10 may be the natural urinary bladder
or an implanted artificial urinary bladder and any reference to the
word bladder in the specification and claims is meant to include
both natural or artificial urinary bladders, except where an
artificial bladder is specified as an element in the claims.
Connected to the bladder 10 is the urethra and/or artificial
urethra 12 that is surrounded by the sphincters 13 which are
muscles that are normally closed so that urine cannot flow out of
the bladder through the urethra. In the normal body these
sphincters 13 are opened or closed by voluntary controlled nerve
impulses. It should be understood that any reference to the word
urethra in the specification and claims is meant to include both
the natural or artificial urethra or other suitable natural or
artificial channel or tube that leads outside the body. An
implanted tube 14 is connected to the bladder 10 and to the inlet
of an implanted pump 15 to permit passage of urine from the bladder
to the pump. An implanted tube 16 is connected to the outlet of the
pump 15 and to the urethra 12 below the sphincters 13 to permit the
passage of urine from the pump to the urethra when the pump is
activated. An implanted pump driving unit 17 that is responsive to
energy received from outside the body is operably connected to the
pump 15 and is controlled and powered by an external pump
activating unit 18 that transmits energy from outside the body
through the skin and into the body to the pump driving unit to
drive the pump.
A pressure sensor 19 is connected to the implanted tube 14 and
detects pressure in the bladder 10 when it fills with urine. An
implanted alarm unit 20 is connected to the pressure sensor 19 by
means of an implanted electrical connection 21 that transmits a
signal to activate the alarm unit when the bladder is full of
urine. A rechargeable implanted power source 22 is connected to the
implanted alarm unit 20 for supplying power to the alarm unit. An
implanted recharging unit 23 is connected to the power source 22 to
permit recharging of the power source. The implanted recharging
unit 23 is energized by means of an external energy transmitter 24
that transmits energy from outside the body through the skin and
into the body to the recharging unit. This energy causes the
recharging unit 23 to recharge the power source 22.
In the preferred embodiment of the invention the pump 15, the pump
driving unit 17, and the external pump activating unit 18 are
similar in construction to the magnetically driven pump and
accessories described in an article entitled "A New Miniature Pump
for the Treatment of Hydrocephalus" by Summers and Matthews in the
May/June 1967 issue of The Journal of the Association for the
advancement of Medical Instrumentation and to the device described
in my co-pending application Ser. No. 741,117 filed June 27, 1968,
now U.S. Pat. No. 3,527,220. In the preferred embodiment the
implanted pump driving unit 17 consists of a suitable rotatable
magnet operably connected to the pump 15 so that the rotation of
the magnet will cause the pump to operate. In the preferred
embodiment the external pump activating unit 18 that is used to
control and operate the pump 15 by transmitting energy into the
body consists of a motor 25 that is operably connected to a
rotatable magnet 26. When the motor 25 is turned on, this causes
rotation of the magnet 26. The rotation of the magnet 26 causes the
implanted magnet in the driving unit 17 to rotate due to the action
of the magnetic field between the external magnet 20 and the
implanted magnet within the driving unit 17. The rotation of the
magnet within the pump driving unit 17 causes the pump 15 to
operate and pump urine from the bladder 10 through the implanted
tube 14, through the pump, and through the implanted tube 16 into
the urethra 12 at a point below the sphincters 13.
Other types of pumps can be employed; however, a magnetically
driven pump is highly desirable since once it has been implanted,
it can be powered from outside the body without having to penetrate
the skin. An alternative type of pump that could be employed would
be driven by implanted batteries that could be recharged by the
action of a rotating magentic field located outside the body.
Activation of this alternative type of pump could be achieved by a
suitable electromagnetic signal from outside the body.
In the preferred embodiment of this invention the external energy
transmitter 24 consists of a motor 27 that is operably connected to
a rotatable magnet 28. When the motor 27 is turned on, this causes
the magnet 28 to rotate which results in the generation of a moving
magnetic field within the implanted recharging unit 23 that causes
the recharging unit to recharge the power source 22. Through the
proper selection of circuitry it is possible that the pump
activating unit 18 can also serve as the external energy
transmitter 24. Alternatively, the implanted recharging unit 23 can
be energized by means of an energy transmitter 24 that includes an
rf generator.
In FIG. 2 an alternative embodiment of the invention is shown in
which the implanted pressure sensor 19 is connected to an implanted
restraining band 29 that partially or totally surrounds the urinary
bladder 10. This pressure sensor 19 is pressed against the wall of
the urinary bladder 10 as the bladder increases in size as a result
of its being filled with urine. When the pressure sensor 19 detects
pressure resulting from the distention of the urinary bladder 10 as
it is filled with urine, the sensor energizes the implanted alarm
unit 20 through implanted electrical connection 21 as previously
described with respect to the embodiment shown in FIG. 1.
FIG. 3 illustrates a circuit diagram of the preferred embodiment of
the implanted alarm unit 20, the implanted power source 22 and the
implanted recharging unit 23. The alarm unit includes a resistive
heating element 30 and a switch 31 that is closed by a signal from
the sensor 19 when the sensor detects pressure resulting from the
filling of the bladder with urine. When the switch 31 is closed,
the resistive heating element 30 becomes heated by the action of
the electrical current generated by the battery 32 in the power
source 22. The resistive heating element 30 must become hot enough
to be sensed by the patient, but not hot enough to cause damage to
the tissue surrounding the implanted resistor. The switch 31 opens
and the heat sensation that results from the resistive heating
element 30 is relieved when the implanted pump 15 is activated and
urine is pumped out of the bladder 10 since the pressure sensor 19
no longer detects pressure in the bladder and thus is not
transmitting a signal to keep the switch 31 in its closed
position.
A test switch 33 that is normally open is connected in parallel
with the switch 31 to permit testing of the alarm unit. This test
switch 33 can be of a type that is magnetically activated so that
it can be closed by a suitable means such as a magnetic source (not
shown) located outside of the body. The battery 32 should be
rechargeable and recharging is accomplished by means of the
implanted recharging unit 23 and the external energy transmitter
24. In the preferred embodiment the recharging unit 23 has an
induction coil 34 that is connected in parallel with the battery 32
and a diode 35 that is connected in series with the induction coil.
The recharging unit is energized from outside the body by the
energy transmitter 24 which in the preferred embodiment has a motor
27 that is used to drive a rotatable magnet 28. A current is
generated in the induction coil by means of a moving magnetic field
by placing the rotating magnet 28 at a point outside the body that
is close to the induction coil in the implanted recharging unit 23.
The ac current that is generated in the induction coil 34 by this
moving magnetic field is rectified by the diode 35 and the
rectified current charges the battery 32. The diode 35 also serves
the purpose of preventing the battery 32 from discharging through
the coil 34. Alternatively, a mechanical vibrator, an optical
source that is visible through the skin, an rf source or an
externally interrogated telemetry unit can be employed as the alarm
unit 20.
The alarm unit 20, the power source 22, the recharging unit 23 and
the pump 15 including the driving unit 17 must be covered by a
suitable inner layer such as standard latex rubber over a suitable
case to protect these implanted devices. This inner layer must then
be coated by a suitable outer layer of material that is compatible
with body tissue. Various types of silicone rubber compositions are
suitable for this outer layer. Some examples of these suitable
compositions are presented in U.S. Pat. No. 3,279,996. These
protective layers also protect the body by electrically insulating
these devices from the body. In a similar manner, the electrical
connection 21 and the pressure sensor 19 must be covered by a
suitable insulating material and by a material such as silicone
rubber that is compatible with body tissue. In addition the tubes
14 and 16 must consist of some material that will not permit
diffusion of urine through their walls and the outside of the tubes
must be coated with silicone rubber or some other such material
that will be compatible with the body tissue.
In some cases it will not be necessary to employ an implanted alarm
unit 20 and associated devices. In this situation the implanted
alarm unit 20, the implanted power source 22, the implanted
recharging unit 23, the implanted pressure sensor 19 and the
implanted electrical connection 21 can be omitted. In this
situation it will also be unnecessary to utilize any sort of
external energy transmitter 24.
To utilize this invention the pump 15 including the connected pump
driving unit 17, the alarm unit 20, the rechargeable power source
22, and the recharging unit 23 are implanted into the body so that
they are located close to the skin. Appropriate anchoring devices
such as wings or tabs of a silicone net-like material can be
attached to these devices to maintain them in their desired
locations within the body. Body tissue will grow through this
net-like material and thus anchor the implanted devices within the
body. The inlet of the pump 15 must also be connected to the
bladder 10 preferably by implanting the tube 14 and connecting it
to the bladder and the pump inlet. The outlet of the pump 15 must
also be connected to a natural or artificial channel 12 that leads
out of the body at a point below the sphincters 13 preferably by
implanting the tube 16 and connecting it to the pump outlet and the
channel. Alternatively the pump outlet can be connected to some
other suitable natural or artificial channel that can be used to
discharge urine from the body. In some cases where the patient
suffers urinary incontinence, in which there is involuntary voiding
of urine, it may be desirable to close the urethra 12 surgically at
some point above where the tube 16 connects to the urethra.
The pressure sensor 19 is also implanted into the body and operably
connected to the bladder 10 for detecting the pressure in the
bladder as it fills with urine. If it is desired to practice the
embodiment of the invention shown in FIG. 1, then the pressure
sensor 19 is implanted and operably connected to the bladder 10 by
connecting it to the implanted tube 14 that is connected to the
bladder. If it is desired to practice the embodiment of the
invention shown in FIG. 2 then the restraining band 29 that can
partially or completely surround the bladder is implanted into the
body around the bladder and the pressure sensor 19 is implanted and
connected to the restraining band. The implanted pressure sensor 19
is also connected to the alarm unit 20 by implanting the electrical
connection 21 and connecting it to the pressure sensor and the
alarm unit.
After the urinary control apparatus has been implanted within the
body, the filling of the bladder 10 with urine will activate the
pressure sensor 19 which, in turn, will activate the alarm unit 20.
In the preferred embodiment activation of the alarm unit will cause
the resistive heating element 30 to generate heat that will be
sensed by the patient. When the patient feels this heat, he will
know that his bladder is full and should be emptied. The patient
can accomplish the emptying of his bladder by activating the pump
15 by means of the implanted pump driving unit 17 and the external
pump activating unit 18. If the motor 25 and the magnet 26 are
employed, the patient places the magnet over the implanted pump
driving unit 17 and starts the motor. The resulting moving magnetic
field causes the implanted magnet in the driving unit 17 to rotate
and this activates the pump 15 to pump urine from the bladder 10
and out of the body. As soon as the patient has pumped sufficient
urine from his bladder 10, the pressure sensor 19 will no longer
detect pressure in the bladder and this will result in deactivation
of the alarm unit 20 and stop the resistive heating element 30 from
generating heat.
In the event that the patient is unable to sense the heat from the
resistive heating element 30 or to use the external rotatable
magnet 26 and motor 25 himself, a suitable heat sensor (not shown)
can be taped on the outside of his skin near the implanted alarm
unit 20 so that it will detect the heat generated by the resistive
heating element 30 when the bladder 10 is full of urine. This heat
sensor can be connected to a suitable external signalling system to
call for assistance in pumping out the bladder. The battery 32 in
the power source 22 can be periodically recharged by use of the
external energy transmitter 24 which can consist of a motor 27 and
a rotatable magnet 28. To recharge the battery 32 with this device
the patient places the magnet 28 over the coil 34 in the recharging
unit 23 and activates the motor to magnetically induce an electric
current in the coil that will recharge the battery. The patient may
also test the alarm unit by activating the test switch 33 which in
the preferred embodiment will simulate the closing of the switch 31
by a signal from the pressure sensor 19 and result in current
flowing in the resistive heating element 30. Thus the patient
should feel heat after the switch is closed if the alarm unit is
operating properly and the battery is charged.
In the event that the patient should develop an infection in his
bladder and it should be desirable to irrigate the bladder, this
can be accomplished through the use of this implanted urinary
control apparatus by merely causing the pump 15 to operate in
reverse to pump a suitable irrigating solution from outside the
body into the bladder 10. When the implanted urinary apparatus is
used for this purpose, the pressure sensor 19 and the alarm unit 20
can serve the purpose of warming the patient when the bladder 10 is
full of the irrigating solution so that the solution will not be
forced up into the kidneys and of preventing undue distention of
the bladder. The pump can also be operated in reverse to cleanse
the implanted apparatus by pumping a suitable solution through the
apparatus from outside the body in the event the apparatus becomes
clogged with uric acid crystals or other matter.
In some cases such as when it is planned to pump urine from the
bladder 10 at preset time intervals by means of the pump 15 and the
associated devices that have been previously described, it will be
unnecessary to utilize the alarm unit 20. In such cases it will be
unnecessary to implant the alarm unit 20, the power source 22, the
recharging unit 23, the electrical connection 21, the pressure
sensor 19, and any associated restraining band 29. In these cases
it is also unnecessary to use any external energy transmitter 24.
When the alarm system 20 is not implanted and utilized, the pump 15
must be activated according to some schedule to insure that the
bladder 10 does not fill with urine to the extent that it would
bring undesirable results.
This invention has been previously described primarily in relation
to its use within the body of a human, however, it can also be
implanted within the body of an animal to control the animal's
urinary functions.
Although the invention has been described in considerable detail
with reference to certain preferred embodiments, it will be
understood that variations and modifications may be made within the
spirit and scope of the invention as defined in the appended
claims.
* * * * *