U.S. patent number 3,870,051 [Application Number 05/354,910] was granted by the patent office on 1975-03-11 for urinary control.
This patent grant is currently assigned to National Research Development Corporation. Invention is credited to Giles Skey Brindley.
United States Patent |
3,870,051 |
Brindley |
March 11, 1975 |
Urinary control
Abstract
Urinary control by electrical stimulation of the sphincter and
bladder muscles is effected by way of the sacral ventral roots,
selection in the resultant muscle action being effected by use of
discriminating signal forms. Sphincter closure action is effected
by use of a low intensity pulse train whereby the sphincter is
stimulated but not the bladder and so incontinence is avoided.
Bladder muscle action to cause micturation is effected by use of a
higher intensity pulse train whereby both muscles are stimulated
during each pulse train, but during each interruption the sphincter
relaxes while the bladder remains contracted.
Inventors: |
Brindley; Giles Skey (London,
EN) |
Assignee: |
National Research Development
Corporation (London, EN)
|
Family
ID: |
10131805 |
Appl.
No.: |
05/354,910 |
Filed: |
April 26, 1973 |
Foreign Application Priority Data
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|
|
|
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Apr 27, 1972 [GB] |
|
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19583/72 |
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Current U.S.
Class: |
607/40;
128/DIG.25; 607/41; 607/59; 607/61; 607/66; 607/72 |
Current CPC
Class: |
A61N
1/36007 (20130101); Y10S 128/25 (20130101) |
Current International
Class: |
A61N
1/36 (20060101); A61n 001/36 () |
Field of
Search: |
;128/419E,419R,421,422,DIG.25 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Kamm; William E.
Attorney, Agent or Firm: Cushman, Darby & Cushman
Claims
We claim:
1. A method of urinary control which comprises applying an
electrical signal of continuous pulse train form to the sacral
ventral roots, said sacral ventral roots communicating with the
sphincter muscle and bladder muscle, thereby causing the step of
contracting said sphincter muscle while said bladder muscle is
relaxed.
2. A method according to claim 1 wherein said pulse train has a
pulse repetition rate of about 20 per second.
3. A method of urinary control which comprises applying an
electrical signal of interrupted pulse train form to the sacral
ventral roots, said sacral ventral roots communicating with the
sphincter muscle and bladder muscle, thereby causing the step of
contracting both of said muscles during each pulse train and the
further step of maintaining said bladder muscle contracted during
part of each interruption period between successive pulse trains
when said sphincter muscle is relaxed.
4. A method according to claim 3 wherein said pulse trains are of
short duration during successive intervals of about 11/2 seconds,
and each comprise about twelve pulses.
5. A method according to claim 4 wherein each of said pulse trains
comprises pulses of about 1/2 millisecond duration each 10
milliseconds.
6. A method of urinary control which comprises alternatively
applying two different pulsatile electrical signals to the sacral
ventral roots, said sacral ventral roots communicating with the
sphincter muscle and bladder muscle to thereby cause the step of
stimulating said muscles, one of said signals being of lower
intensity and higher repetition rate for causing the step of
contracting said sphincter muscle while said bladder muscle is
relaxed, and the other signal being of higher intensity and lower
repetition rate for causing the step of contraction of both of said
muscles during each pulse and to cause the further step of
maintaining said bladder muscle contracted during part of
successive inter-pulse periods when said sphincter muscle is
relaxed.
7. A method of urinary control in primates, comprising:
applying pulsing electrical signals to the sacral ventral roots
which control contraction of the detrusor muscle for the bladder
and the striated, sphincter muscles which contribute to closing the
urethra, in two different modes;
in the first of which, the signals are of a first intensity for the
step of contracting the urethra closing muscles, but not
contracting the bladder detrusor muscle, and including the step of
spacing the first intensity pulses such that the urethra closing
muscles do not become substantially relaxed between pulses; and
in the second of which, the signals are of a second intensity
higher than said first intensity signals for causing the step of
contracting both the urethra closing muscles and the bladder
detrusor muscle, and including the step of spacing the second
intensity pulses such that the urethra closing muscles, but not the
bladder detrusor muscle become relaxed between pulses, such that
pressure exerted on the bladder by the detrusor muscle in between
pulses when the urethra closing muscles have relaxed, forces urine
from the bladder and out through the urethra.
8. The method of claim 7, wherein the applying step comprises:
implanting in the subject primate:
a. electrode means disposed for stimulating the third and fourth,
left and right sacral ventral motor nerve fibre roots, without
substantially stimulating sensory nerve fibres;
b. multivibrator means and an electrical power supply therefor, for
emitting said first intensity signals and a connection for
communicating these signals to said electrode means;
c. inhibiting means for preventing communication of said first
intensity signals to said electrode means upon command;
d. receiver means for receiving a command signal from outside the
subject primate and connected to the inhibiting means for
commanding same;
e. multivibrator means for emitting said second intensity signals
and a connection for communicating these signals to said electrode
means;
f. receiver means for receiving a command signal from outside the
subject primate and connected to the multivibrator means to emit
said second intensity signals;
wherein changing modes from the first to the second comprises:
sending command signals from outside the subject primate to the
receiver means of (d) and to the receiver means of (f); and
wherein changing modes from the second to the first comprises:
terminating the sending of said command signals from outside the
subject primate.
9. The method of claim 8, wherein: the implanted multivibrator
means of (b) includes electrical output intensity adjustment means
and the method further comprises: post operatively adjusting the
intensity of signals provided by the implanted multivibrator means
of (b) by adjusting the intensity adjustment means to ensure
desired first mode operation wherein there occurs contraction of
the striated, sphincter muscles which contribute to closing the
urethra without substantially contracting the bladder detrusor
muscle.
10. Urinary control apparatus comprising:
a. stimulating electrode devices adapted for connection to the
sacral ventral roots;
b. a first electrical circuit means operable to generate a low
intensity, continuous pulse train signal, which circuit means is
connected to said electrode devices to energize the same;
c. a second electrical circuit means operable to generate a high
intensity, interrupted pulse train signal, which circuit means is
connected to said electrode devices to energize the same; and
d. means for alternatively activating said first and second circuit
means to energize said electrode devices;
e. said electrode devices and at least part of both said first and
second circuit means being adapted for bodily implantation, and at
least part of said activating means being for use outside the
body.
11. Urinary control apparatus comprising:
a. stimulating electrode devices adapted for connection to the
sacral ventral roots;
b. an implantable electric circuit means, including a power source,
operable to generate a low intensity continuous pulse train signal,
which circuit means is connected to said electrode devices to
energize the same;
c. radio transmitter means for use outside the body operable to
generate a first signal including at least a high intensity
interrupted pulse train and a second signal;
d. an implantable first radio receiver means operable in response
to said interrupted pulse train and connected to said electrode
devices to energize the same; and
e. an implantable second radio receiver means operable in response
to said second signal and connected to said electric circuit to
inhibit operation of the same.
12. Apparatus for effecting urinary control in primates by applying
pulsing electrical signals to the sacral ventral roots which
control contraction of the detrusor muscle for the bladder and the
striated, sphincter muscles which contribute to closing the
urethra, in two different modes;
in the first of which, the signals are of a low intensity so as to
contract the urethra closing muscles, but not to contract the
bladder detrusor muscle, and wherein these low intensity signals
are of such spacing between pulses that the urethra closing muscles
do not become substantially relaxed between pulses; and
in the second of which, the signals are of a different intensity
higher than said low intensity signals so as to contract both the
urethra closing muscles and the bladder detrusor muscle, but of
such spacing between pulses, that the urethra closing muscles, but
not the bladder detrusor muscle become sufficiently relaxed between
pulses, that pressure exerted on the bladder by the detrusor muscle
in between pulses when the urethra closing muscles have relaxed,
forces urine from the bladder and out through the urethra;
said apparatus comprising a surgical implant which includes:
a. electrode means being disposed, when implanted, to stimulate the
third and fourth, left and right sacral ventral motor nerve fibre
roots, without substantially stimulating sensory nerve fibres;
b. multivibrator means including an electrical power supply
therefor, for emitting said low intensity signals and a connection
for communicating these signals to said electrode means;
c. inhibiting means for preventing communication of said low
intensity signals to said electrode means upon the occurrence of a
first command signal;
d. receiver means for receiving the first command signal from
outside the subject primate and connected to the inhibiting means
for controlling same;
e. multivibrator means for emitting said higher intensity signals
and a connection for communicating these signals to said electrode
means;
f. receiver means for receiving a second command signal from
outside the subject primate and connected to the multivibrator
means of (e) for commanding and powering that multivibrator means
to emit said higher intensity signals;
and said apparatus further comprising external transmitter means
for sending said first and second command signals;
whereby, the sending of command signals from outside the subject
primate to the receiver means of (d) and to the receiver means of
(f) places urinary control in the second mode thereof and
terminating the sending of said command signals places urinary
control in the first mode thereof.
Description
BACKGROUND OF THE INVENTION
This invention concerns urinary control and more particularly such
control involving electrical stimulation by way of implanted
electrodes. Also, the invention more particularly, but not
exclusively, concerns urinary control for persons having disorders
of neurological origin whereby they are unable to empty urine from
the bladder by normal action of the bladder muscle, or unable to
retain urine in the bladder by normal action of the sphincter, or,
as is often the case, are unable to do either.
Various attempts have been made in the past to effect urinary
control in the presence of such disorders by direct stimulation of
appropriate muscles through electrodes implanted on the muscle to
stimulate the associated motor nerve fibres. However, relatively
large currents are required to effect the desired muscle
contractions and, because the relevant motor nerve fibres are
normally in close proximity with sensory fibres, stimulation is
frequently associated with pain.
SUMMARY OF THE INVENTION
In a more general aspect, the present invention, on the other hand,
affords similar urinary control by stimulation of the relevant
muscles through electrodes implanted in the associated parts of the
sacral ventral roots, normally numbers three and four, left and
right. The muscles in question will be referred to hereinafter for
convenience simply as the bladder muscle and the sphincter muscle.
The former is intended to denote the detrusor muscle of the
bladder, and the latter all of those striated muscles that
contribute to closing the urethra. The principal one of these last
muscles is the external sphincter of the urethra, but other pelvic
muscles are also considered to be involved.
An advantage of the presently proposed control is that the sacral
ventral roots are free from sensory fibres with the result that
stimulation is unlikely to lead to pain. Also, it is more economic
in terms of power requirements to stimulate the sacral ventral
roots than the muscles directly or the motor nerve fibres in
them.
However, the sacral ventral roots in question comprise tightly
packed bundles including those which govern the activity of the
bladder muscle and those which govern the activity of the sphincter
muscle. Accordingly, unless it proves possible to separate the
respective fibres, and this seems an impossible task on the basis
of existing knowledge, it is necessary to adopt a mode of
differential stimulation.
The invention involves one mode of differential stimulation which
stems from the fact that the bladder muscle relaxes slowly after
stimulation to contraction, while the sphincter muscle relaxes very
rapidly in comparison. Thus, it is possible to stimulate the
relevant fibres with electrical signals of interrupted form so that
both muscles are contracted during each active signal period, while
the bladder muscle remains contracted and the sphincter muscle is
relaxed to afford micturition during at least a part of the signal
interruption period. In practice each active signal will normally
comprise a pulse train and the relevant interruption period is the
inter-train interval.
Another mode of differential stimulation stems from the fact that
the sacral ventral root fibres governing the activity of the
bladder muscle are small compared to those for the sphincter
muscle, and it follows that the latter fibres are more sensitive to
electrical stimulation than the former. Thus, it is possible to
stimulate the fibres at an intensity which causes contraction of
the sphincter muscle but not the bladder muscle. Again, this
stimulation will normally involve the use of a pulse train
signal.
It will be normal for the purposes of the earlier-mentioned more
particular application of the invention to employ both of these
modes of differential control with the second mode being employed
to hold the sphincter normally contracted except when the first
mode is employed to empty the bladder.
As clarification, useful mention can be made of practical
development of the invention to date. This development has led to
urinary control apparatus for which the normal or hold mode
involves stimulation by application of a relatively low intensity
pulse train signal having a pulse repetition rate of about twenty
per second, and the micturition or empty mode involves stimulation
by application of a relatively high intensity, interrupted pulse
train signal in which each train comprises about twelve pulses in a
relatively short burst each 1 1/2 seconds.
Regarding practical implementation of the invention: the power
requirements for the two modes of stimulation are sufficiently low,
namely, low intensity for long durations and high intensity for
short durations, that implantation of suitable micro-circuits with
battery power supplies is possible. However, it is necessary to
provide some facility, controllable from without the body, to
afford switching between the hold and empty modes of control. This
can be effected by use of a radio transmitter/receiver arrangement
as more generally described in U.S. Pat. No. 3,699,970 whereby an
externally located transmitter is operated to energise an implanted
receiver. Indeed, the use of such arrangements would allow both the
hold and empty modes of control to be individually powered from
without the body and so obviate the need for any implantation of
power supplies.
In practice the present development has involved implementation
with a compromise between these effective extremes of maximum and
minimum implantation. In this compromise, the hold mode of control
is provided by way of total implantation, and the empty mode by way
of a transmitter/receiver arrangement which also serves to inhibit
the hold mode. This overall arrangement is presently considered to
represent an optimum in convenience to the beneficiary.
BRIEF DESCRIPTION OF THE DRAWING
For completeness in providing a clear understanding of the
invention, one embodiment of the last-mentioned overall arrangement
is illustrated, partly in diagrammatic form and partly in circuit
diagram form, in the accompanying drawing. This embodiment has been
successfully tested in animal trials with a baboon and is
considered applicable to man.
DETAILED DESCRIPTION OF A PRESENTLY PREFERRED EMBODIMENT
The illustrated embodiment is in two parts denoted at 10 and 11 of
which the first is implantable and the second employed externally
of the body. Also these two parts 10 and 11 are themselves
functionally subdivided into portions 10A, 10B and 11A, 11B,
although this subdivision does not necessarily involve physical
separation.
The implantable portion 10A is the circuit which provides the hold
mode of control referred to above and comprises a complementary
multivibrator stage 20 operable to generate a pulse train of twenty
pulses per second which are applied through a buffer stage 21 and
output stage 22 to stimulating electrodes 23A. The electrodes 23A
are located adjacent the relevant ventral sacral roots by use of
electrode terminal devices such as described in U.S. Pat. No.
3,718,134 and the tissue load at the electrodes is denoted by
broken line resistor R1A. This circuit is powered by a mercury cell
24, resistor R2 in the multivibrator stage is chosen so that fifty
microsecond pulses are generated, and the potentiometer R3 affords
adjustment of the output pulse intensity to a low level at which
only the sphincter muscle is contracted. Potentiometer R3 is
preferably adjustable post-operatively from without the body and
this can be effected by use of a magnetic coupling.
The remaining components of the relevant circuit constitute an
inhibiting stage 25 in the form of a simple radio receiver which is
actuated in response to the external portion 11A to hold the
multivibrator transistor switched off.
The implantable portion 10B is also of simple radio receiver form
and serves, in response to the external portion 11B, to energise
further stimulating electrodes 23B, in response to the external
portion 11B.
As will be apparent from the above discussion, the external
portions 11A, 11B are radio transmitters and it is unnecessary to
consider more detailed circuit design since these portions can be
of any suitable form to serve the relevant function
requirements.
The more complex of these requirements is for the portion 11B which
as mentioned earlier is to provide a relatively high intensity,
interrupted pulse train signal. In the development in question the
portion 11B comprised two multivibrators connected in cascade, with
the first activating the second for a period of 120 milliseconds
each 11/2 seconds, the second generating 121/2 millisecond pulses
at 91/2 milliseconds separation during each period of activation,
and the last-mentioned pulses gating the radio frequency output of
the relevant transmitter.
The more simple requirement is for the portion 11A which is
operated at the same time as portion 11B to provide a radio signal
to inhibit the portion 10A.
Component values in the illustrated circuits are as follows:
R3 = 50K , R4 = 5K R5 = 10K , R6 = 20K R7 = 47K , R8 = 100K R9 = 1M
, C1 = 100p C2 = 0.01.mu. , C3 = 1.mu.
While the invention has been described, and indeed developed so
far, with reference to urinary control in respect of disorders of
neurological origin, the invention may afford similar control in
respect of disorders of non-neurological origin, such as urinary
incontinence arising from gynaecological defects. By the same
token, it will be appreciated that use of both of the
above-discussed more specific modes of control is not essential in
all applications of the invention.
* * * * *