U.S. patent number 3,575,158 [Application Number 04/842,921] was granted by the patent office on 1971-04-20 for method of controlling urine flow from the bladder with an inplantable pump.
This patent grant is currently assigned to Fairchild Hiller Corporation. Invention is credited to George D. Summers.
United States Patent |
3,575,158 |
Summers |
April 20, 1971 |
METHOD OF CONTROLLING URINE FLOW FROM THE BLADDER WITH AN
INPLANTABLE PUMP
Abstract
An implantable urinary control apparatus for controlling the
flow of urine from the bladder including a pump connected to the
bladder for pumping urine out of the bladder and into a natural or
artificial channel so that it can be discharged from the body. The
apparatus also includes a sensor 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. A method of controlling the flow of urine from the bladder
including implanting and connecting a pump to the bladder and
activating the pump to pump urine from the bladder when the bladder
is filling with urine. The method also includes implanting a sensor
in the body for detecting the pressure in the bladder as it fills
with urine, and implanting and connecting an alarm unit to the
sensor so that the alarm unit will give 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 Hiller Corporation
(Montgomery County, MD)
|
Family
ID: |
25288579 |
Appl.
No.: |
04/842,921 |
Filed: |
July 18, 1969 |
Current U.S.
Class: |
600/30;
128/DIG.25; 623/23.66; 623/23.68; 604/544 |
Current CPC
Class: |
A61F
2/0036 (20130101); Y10S 128/25 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61b 019/00 (); A61f 001/24 () |
Field of
Search: |
;3/1 (Digest/ 2)/
;128/1,1.3,1.5,214,273 ;417/411,420 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"The Use of A Magnetic Field to Remotely Power An Implantable Blood
Pump. Preliminary Report" by B. K. Kusserow, Transactions American
Society For Artificial Internal Organs, Volume VI, 1960, pp.
292--294. Copy in Group 335, 3-Dig. 2. .
"A New Minature Pump For the Treatment of Hydrocephalus" by G. D.
Summersetal, Journal of the Assoc. for the Advancement of Medical
Instrumentation, Vol. 2, No. 3, May/June 1967, pp. 9--16.
3-1.
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Claims
I claim:
1. A method of controlling the flow of urine from the urinary
bladder in a body comprising the steps of implanting a pump in the
body and operatively connecting the inlet of said pump to said
urinary bladder and operatively connecting the outlet of said pump
to a natural or artificial body channel that leads from the body,
providing means for operating and controlling said pump, and
activating said operating and control means to operate and control
said pump to pump urine from said urinary bladder through said
natural or artificial channel and out of the body when said bladder
is filling with urine.
2. The method of claim 1 wherein said step of providing means for
operating and controlling said pump comprises implanting, in the
body, a pump driving unit operatively connected to said pump that
is responsive to energy received from outside the body and
providing means outside the body to transmit energy to said
pump-driving unit.
3. The method of claim 1 including the step of implanting a sensor
in the body and operatively connecting said sensor to said bladder
so that said sensor will detect pressure in said bladder as said
bladder is filling with urine.
4. The method of claim 3 including the step of implanting an alarm
unit in the body and operatively connecting said alarm unit to said
sensor so that said alarm unit will give warning that said bladder
is filling with urine when said sensor detects pressure in said
bladder is the result of the filling of said bladder with
urine.
5. The method of claim 4 wherein said step of implanting an alarm
unit in the body also includes implanting in the body a power
source operatively connected to said alarm unit for supplying power
to said alarm unit.
6. The method of claim 5 wherein said step of implanting a power
source also includes implanting in the body a recharging unit
operatively connected to said power source and including the
additional steps of, providing means located outside the body for
transmitting energy into the body to energize said recharging unit
to cause said recharging unit to recharge said power source, and
activating said energy-transmitting means to recharge said power
source.
Description
SUMMARY
This invention relates to an implantable control apparatus and
control method, more particularly, this invention relates to an
implantable control apparatus and control method 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 diaperlike 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 copending
application Serial No. 814,760 filed Apr. 9, 1969 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.
A further object of this invention is to provide a method for
artificially controlling the discharge of urine from the
bladder.
The present invention provides an implantable urinary control
apparatus for controlling the flow of urine from the urinary
bladder that includes a pump connected to the bladder for pumping
urine from the bladder, and means for controlling and powering the
pump. The control apparatus also provides a sensor operably
connected to the bladder for detecting the pressure in the bladder
caused by the filling of the bladder 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 due to the
presence of urine in the bladder.
The present invention provides a method for artificially
controlling the discharge of urine from the urinary bladder that
includes implanting a pump into the body, connecting one side of
the pump to the bladder, connecting the other side of the pump to a
natural or artificial body outlet, and activating the pump to
discharge urine from the bladder when the bladder is filling with
urine. The method also includes implanting and operably connecting
a sensor to the bladder for detecting the pressure in the bladder
as the bladder fills with urine, and implanting and connecting an
alarm unit to the sensor so that the alarm unit will give warning
that the bladder is filling with urine when the sensor detects the
pressure caused by the presence of urine in the bladder.
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 diagrammatic view showing typically how the invention
would be implanted within the body of a human;
FIG. 2 is a diagrammatic 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 changing
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. 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 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 devices described
in my copending application Serial No. 74l,117 filed Jun. 28, 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 26 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 magnetic 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 practice 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 netlike material can be
attached to these devices to maintain them in their desired
locations within the body. Body tissue will grow through this
netlike 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 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 warning 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 present 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.
* * * * *