U.S. patent number 3,646,940 [Application Number 04/841,756] was granted by the patent office on 1972-03-07 for implantable electronic stimulator electrode and method.
This patent grant is currently assigned to The Regents of the University of Minnesota. Invention is credited to William E. Bradley, Gerald W. Timm.
United States Patent |
3,646,940 |
Timm , et al. |
March 7, 1972 |
IMPLANTABLE ELECTRONIC STIMULATOR ELECTRODE AND METHOD
Abstract
An apparatus for implantation in the body to locally stimulate a
mass of electrically excitable tissue without stimulating nearby
tissue structures, and the method of so stimulating the tissue is
described. The apparatus includes a plurality of electrodes, each
of the electrodes including a pair of conductors for carrying
signals of positive and negative polarity, each of said conductors
having a plurality of electrically conductive coupling points for
coupling to the mass of tissue. Apparatus is also described for
providing timed sequenced electrical impulses to the plurality of
electrodes so that only one of the electrodes has a voltage applied
between its input terminals at any given time. An insulating
backing placed between the electrodes and tissue structures
surrounding the implanted stimulator for eliminating undesirable
secondary tissue stimulation is also described. The method of
applying controlled time-spaced electrical impulses to a mass of
electrically excitable tissue structure for causing stimulation of
that tissue structure is also described.
Inventors: |
Timm; Gerald W. (Minneapolis,
MN), Bradley; William E. (Minneapolis, MN) |
Assignee: |
The Regents of the University of
Minnesota (Minneapolis, MN)
|
Family
ID: |
25285621 |
Appl.
No.: |
04/841,756 |
Filed: |
July 15, 1969 |
Current U.S.
Class: |
607/40; 607/51;
607/66 |
Current CPC
Class: |
A61N
1/36007 (20130101) |
Current International
Class: |
A61N
1/36 (20060101); A61n 001/36 () |
Field of
Search: |
;128/404,410,411,416,418P,419R,421,422 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Kamm; William E.
Claims
We claim:
1. Apparatus for stimulating a mass of electrically excitable
tissue comprising:
a. a plurality of electrically conductive electrode means for
electrically coupling to a mass of electrically excitable tissue,
said electrode means including a pair of electrically conductive
wires, a first plurality of electrical interconnection elements
electrically coupled to one of said pair of conductive wires, and a
second plurality of electrical interconnection elements
electrically coupled to the other of said pair of conductive wires,
electrically conductive connection means for electrically
interconnecting each of said interconnection elements with
predetermined portions of the tissue to be stimulated, insulation
means for insulating said pair of electrically conductive wires
while leaving said first and second pluralities of interconnection
elements exposed, and isolation means coupled to said plurality of
conductors for electrically isolating each of said electrode means
from the others of said electrode means;
b. pulse-generating means for providing predetermined timed
sequences of electrical pulses, said pulse-generating means
including tuned circuit means for responding to radiofrequency
signals for providing power signals; rectifier and filter means
coupled to said tuned circuit means for providing direct current
signals in response to said power signals; and
c. control means coupled intermediate said plurality of electrodes
and said pulse-generating means for controlling the time and
sequence of application of said electrical pulses to individual
ones of said electrode means, said control means including clocking
means for controlling said time and sequence of application of said
electrical pulses to only one of said electrode means at any given
time, and including pulse circuit means coupled to said rectifier
and filter means for generating pulses in response to said direct
current signals, a plurality of insulated electrical conductors
electrically coupled intermediate said pulse circuit means and said
plurality of electrically conductive electrode means for
transmitting said pulses to said electrode means; said clocking
means coupled to said pulse circuit means for controlling the
sequence of said transmitting of said pulses to individual ones of
said plurality of electrically conductive electrode means in a
predetermined order.
2. Apparatus as in claim 1 and further including further insulation
means for electrically insulating said plurality of electrode means
from contiguous stimulatable tissue structures for inhibiting
undesired stimulation thereof.
3. Apparatus for stimulating a mass of electrically excitable
tissue comprising:
a. a plurality of electrically conductive electrode means for
electrically coupling to a mass of electrically excitable
tissue:
b. pulse-generating means for providing predetermined timed
sequences of electrical pulses, said pulse generating means
including a like plurality of power source means for generating
sequences of signals, and a like plurality of pulse-generating
means, each of said pulse-generating means electrically coupled to
a respectively associated one of said plurality of power source
means for providing said pulses to an associated one of said
plurality of electrodes; and
c. control means coupled intermediate said plurality of electrodes
and said pulse-generating means for controlling the time and
sequence of application of said electrical pulses to individual
ones of said electrode means, said control means including clock
circuit means coupled to said plurality of pulse-generating means
for controlling said time and sequence of application of said
pulses to only one of said electrode means at any given time, said
clock circuit means including means for isolating each of said
electrode means from the others of said electrode means.
4. Apparatus as in claim 3 wherein each of said electrode means
includes a pair of electrically conductive wires, a first plurality
of electrical interconnection elements electrically coupled to one
of said pair of conductive wires, and a second plurality of
electrical interconnection elements electrically coupled to the
other of said pair of conductive wires, and insulation means for
insulating said pair of electrically conductive wires while leaving
said first and second pluralities of interconnection elements
exposed.
5. Apparatus as in claim 4 and further including electrically
conductive connection means for electrically interconnecting each
of said interconnection elements with predetermined portions of the
tissue to be stimulated.
6. Apparatus for stimulating a mass of electrically excitable
tissue comprising:
a. a plurality of electrically conductive electrode means for
electrically coupling to a mass of electrically excitable tissue,
said electrode means including a pair of electrically conductive
wires, a first plurality of electrical interconnection elements
electrically coupled to one of said pair of conductive wires, and a
second plurality of electrical interconnection elements
electrically coupled to the other of said pair of conductive wires,
electrically conductive connection means for electrically
interconnecting each of said interconnection elements with
predetermined portions of the tissue to be stimulated, insulation
means for insulating said pair of electrically conductive wires
while leaving said first and second pluralities of interconnection
elements exposed, and isolation means coupled to said plurality of
conductors for electrically isolating each of said electrode means
from the others of said electrode means;
b. pulse-generating means for providing predetermined timed
sequences of electrical pulses, said pulse-generating means
including tuned circuit means for responding to high-frequency
signals for providing power signals; rectifier and filter means
coupled to said tuned circuit means for providing direct current
signals in response to said power signals; and
c. control means coupled intermediate said plurality of electrodes
and said pulse-generating means for controlling the time and
sequence of application of said electrical pulses to individual
ones of said electrode means, said control means including clocking
means for controlling said time and sequence of application of said
electrical pulses to only one of said electrode means at any given
time, and including pulse circuit means coupled to said rectifier
and filter means for generating pulses in response to said direct
current signals, a plurality of insulated electrical conductors
electrically coupled intermediate said pulse circuit means and said
plurality of electrically conductive electrode means for
transmitting said pulses to said electrode means; said clocking
means coupled to said pulse circuit means for controlling the
sequence of said transmitting of said pulses to individual ones of
said plurality of electrically conductive electrode means.
7. The method of stimulating a mass of electrically excitable
tissue while preventing undesired stimulation of contiguous tissue
structures comprising the steps of:
a. electrically affixing a set of spaced-apart electrodes to the
mass of tissue to be stimulated, said step of affixing including
the steps of:
1. providing a plurality of electrical interconnection points on
each of the electrodes;
2. selecting predetermined points of contact; and
3. suturing with electrically conductive wire each of the
electrical interconnection points to predetermined depths in the
tissue to be stimulated for electrically coupling to the neural
system innervating the tissue to be stimulated; and
b. generating pulses with a pulse source and applying the generated
pulses to one electrode at a time in a predetermined sequence.
8. The method of claim 7 and further including the steps of:
a. implanting a controlled pulse source in the body; and
b. placing an insulating cover over the implanted pulse source and
those portions of the electrodes other than said predetermined
points of contact for further minimizing undesired stimulation of
contiguous tissue structures.
9. A bipolar electrode for use with an implantable stimulator for
stimulating electrically excitable tissue comprising:
a. a pair of electrically conductive wires for receiving bipolar
pulses, one of said pair of electrically conductive wires being
arranged in a predetermined serpentine pattern, and the other of
said pair of electrically conductive wires being arranged in
substantially a mirror image of said predetermined serpentine
pattern and overlaps said one wire at a plurality of points;
b. a first plurality of spaced-apart electrical interconnection
elements electrically coupled to one of said pair of conductive
wires; a second plurality of spaced-apart electrical
interconnection elements electrically coupled to the other of said
pair of conductive wires; with individual ones of said first and
second pluralities of interconnection elements paired and
positioned at approximately the midpoints between associated ones
of said plurality of overlap points; and
c. insulation means for insulating said pair of electrically
conductive wires while leaving said first and second pluralities of
interconnection elements exposed.
Description
The invention described herein was made in the course of work under
a grant or award from the Department of Health, Education and
Welfare.
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to apparatus and method for artificially and
electrically stimulating masses of electrically excitable tissue.
More specifically, this invention relates to an apparatus and
method for electrically stimulating tissue in those persons who
have lost the voluntary neural control of this excitable mass
because of injury or disease, such as for example, loss of bladder
function due to spinal cord injury.
2. Description of the Prior Art
Certain systems for artificially stimulating muscle activity are
known to the prior art. One of the systems developed in the prior
art is described in U.S. Pat. No. 3,236,240. The apparatus therein
disclosed utilized spaced-apart electrodes to stimulate large areas
of the bladder smooth muscle with volitionally generated electrical
signals. It has been found that stimulation of such large areas
usually results in stray electrical signals causing stimulation of
nearby muscles and excitable tissue, an undesired secondary effect.
In some instances, it has been determined that the stimulating
signals cause a dual effect, the bladder muscle attempts to
contract, as desired for evacuation thereof, but also the
contraction of the external urethral sphincter takes place thereby
inhibiting the evacuation of fluid from the bladder. Previous
methods and apparatus of stimulating large tissue masses exhibit a
disadvantage in that additive fields in the vicinity of the
stimulated muscle can still occur owing to the parallel connection
of multiple electrodes. That is, by the simultaneous application of
a plurality of electrical fields resulting from the application of
equal voltages to each of the electrodes, there will be generated
at various points in the stimulated muscle, electrical fields that
are greater than the individual fields resulting from each of the
electrodes. Since the surrounding muscle tissue of concern often
contains rapidly accommodating nerve fibers with low stimulus
thresholds, these increases in field strength can be sufficient to
cause undesired muscle fiber stimulation.
SUMMARY
In summary, then, this invention comprises a method and apparatus
for locally stimulating masses of electrically excitable tissue in
the presence of other excitable physiologic structures. Unless
specific limitation is set forth, "muscle" will often be used
generically to cover all masses of electrically excitable tissue
structures. The apparatus developed includes circuitry for
providing nonsimultaneous or sequentially timed electrical impulses
to various portions of the excitable mass. A plurality of
electrodes are electrically coupled to the mass, for instance the
detrusor muscle of a urinary bladder, for providing electrical
stimulation to the neural conducting system innervating the muscle
in response to the application of electrical energy to individual
ones of the electrodes. Clocking and gating circuits are used for
controlling the time and sequence of application of electrical
impulses to the electrodes in a manner such that only one electrode
is energized at any given time. In order to maximize the
effectiveness of the nonsimultaneous or sequentially timed
electrical impulses, specially formed electrodes are utilized.
These electrodes are bipolar in construction and are arranged to
have a plurality of electrically conductive connection points for
coupling to the muscle at a plurality of positions. Insulation is
provided for electrically isolating the electrodes from contiguous
muscle structures that might receive undesired stimulations.
Urinary sepsis secondary to neurogenic dysfunction associated with
spinal cord trauma, has been recognized as a clinical problem.
Further, it has been recognized that prolonged use of indwelling
catheters in paraplegic patients produces significant bacteriuria,
cystitis, vesical calculi, and pyelonephritis. Bladder tonus, or
the response of the bladder smooth muscle to the stretch imposed by
filling, has been described as an intrinsic property of smooth
muscle and not reflex in nature. Changes in this response are shown
to follow physical alteration in the bladder tissue. Regular,
complete evacuation of the neurogenic bladder with avoidance of
inflection and damage, is therefore an aid in preserving normal
tonus and facilitating rehabilitation of bladder function.
Electrical excitability of the mammalian bladder has been
demonstrated. Further, various forms of implantable muscle or
bladder stimulators have been described, as indicated by U.S. Pat.
No. 3,236,240.
It is a primary object of this invention to provide a method and
apparatus for providing electrode means, delivering electrical
impulses to the electrode means extending over an adequate mass and
at a sufficient depth in the mass of excitable tissue to activate
the neural conduction system innervating the mass. Yet another
object of this invention is to provide apparatus including
electrode means, circuitry for providing nonsimultaneous electrical
impulses to the electrode means electrically coupled to various
portions of an excitable tissue structure. Still another object of
this invention is to provide an implantable stimulator that
utilizes a plurality of electrodes with the electrode being
electrically coupled to the excitable tissue structure, for
instance the detrusor muscle of the urinary bladder, for providing
electrical stimulation to the neural conducting system innervating
the structure, in response to the application of timed electrical
energy impulses. Still another object of this invention, is to
provide an implantable muscle stimulator apparatus having electrode
means with circuitry including clocking and gating circuits being
utilized for controlling the time and sequence of application of
electrical impulses to a plurality of such electrodes in a manner
such that only one electrode is energized at any given time. Still
another object of this invention is to provide a practical method
and means for artificially and electrically stimulating the bladder
muscle to permit regular, complete evacuation, with the avoidance
of infection and tissue damage. It is a further object of this
invention to provide an implantable internal bladder stimulator in
the form of electrodes coupled to a radio frequency receiver with
the electrodes attached at a plurality of points to the bladder
muscle, capable of providing properly timed stimuli of the bladder
muscle when used in conjunction with an external radiofrequency
transmitter. Still another object of this invention is to provide a
passive internal bladder muscle stimulator adapted to be implanted
subcutaneously and being provided with electrodes which are
electrically attached to the bladder muscle, wherein the stimulator
derives its properly timed stimulation power for each of the
electrodes from an external high-power radiofrequency transmitter.
Yet a further object of this invention is to provide an implantable
muscle stimulator that is so operated in a nonsimultaneous manner
of activation of a plurality of electrodes, and is so insulated,
that contiguous tissue structures to which the electrodes are
coupled are not stimulated. Also, the stimulator provides
nonsimultaneous impulses to a plurality of electrodes by way of
output circuits electrically isolated and arranged so that current
flow between the output circuits is prevented thereby preventing
the generation of massive current fields between the electrodes.
The foregoing and other more detailed and specific objectives will
become apparent from the following detailed description of the
invention setting forth in detail certain illustrative embodiments
of the invention, these being indicative, however, of but a few of
the various ways in which the principle of the invention may be
employed.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be described with reference to the drawings in
which:
FIG. 1 is a perspective view of an internal implantable stimulator
according to the present invention;
FIG. 2 illustrates the timed sequential application of electrical
pulses to individual stimulator electrodes when, for example, n=3,
or three output circuits are utilized;
FIG. 3 illustrates a type of bipolar electrode design utilizing two
coils of conductor and having a plurality of electrical
interconnection points;
FIG. 4 illustrates a characteristic placement of electrodes on a
urinary bladder, with two electrodes near the lateral ligaments on
the ventral surface and one electrode on the caudal-rostral midline
of the dorsal surface;
FIG. 5 illustrates a method of electrically connecting an electrode
into the depth of a muscle structure, and illustrates the
insulating backing for providing electrical isolation of stimuli
from contiguous excitable structures surrounding a muscle;
FIG. 6 is a schematic block circuit diagram of an implantable
muscle stimulator deriving its stimulation power from an external
power transmitter, and having clocking and pulse circuits for
applying electrical impulses to only one electrode at a time;
FIG. 7 is an alternative embodiment of the invention, and is a
schematic block circuit diagram of an implantable muscle stimulator
utilizing a separate power source and pulse circuit for each
bipolar electrode with isolating clock circuitry for determining
the pulse application sequence so that only one electrode is
energized at any instant of time;
FIG. 8 is a plot of a characteristic muscle pressure response
derived from the simultaneous application of a plurality of
electrical impulses; and
FIG. 9 is a characteristic plot of pressure response obtained from
a muscle having a plurality of electrical impulses sequentially
applied.
DESCRIPTION OF THE PREFERRED EMBODIMENT
As shown in FIG. 1, the implantable stimulator comprises a
receiver, indicated generally at 10, and a plurality of bipolar
electrodes 11 for attachment to the muscle. The electrodes 11 are
connected to the receiver 10 by electrical conductors 12. The
receiver 10 is encased in a protective mass 13, preferably
sterilizable, inert, nonirritating and nontoxic protective
material, for example composed of a synthetic resinous material.
The conductors 12 are similarly encased in protective sheets 14,
shown foreshortened to expose the conductive wires 12. The
electrodes 11 are bipolar and receive voltage signals V1 through Vn
respectively. Each of the electrodes 11 is adapted for coupling to
a pair of lines 12, with one of the lines 12 being designated + and
others of the line 12 being designated -.
As summarized above, the invention embodies a method and apparatus
for applying electrical stimuli to large masses of excitable muscle
tissue without current spread to excitable tissue contiguous to the
muscle to be stimulated. The stimuli are applied through the
multiple bipolar electrodes 11 with the two poles of each electrode
being electrically isolated from any of the poles of the other
electrodes. In addition, the stimuli are developed in a manner
whereby only one electrode has a voltage applied between its poles
at any given time. In this regard, attention is directed to FIG. 2.
There it can be seen that voltage pulses are applied to the bipolar
electrodes in a nonsimultaneous or ordered manner so that additive
stimulus fields are prevented. In FIG. 2, voltage along the
vertical axis is plotted versus time along the horizontal axis,
with the time being expressed in groupings of milliseconds.
While it is intended that the implantable stimulator 10 will be
utilized with various kinds of muscles, specific examples of
pulsing rates have been developed for the detrusor muscle of a
urinary bladder. In this regard, experiments show effective
stimulus application rates for bladder muscles is between
approximately 10 and 40 pulses per second with pulse durations
between 0.5 and 5 milliseconds at each bipolar electrode 11, with
voltage amplitude of up to about 50 volts. Stimulus rates up to 120
pulses per second with durations as short as 0.1 millisecond are
found to be effective for intestine and other muscle stimulation.
Of course it is readily apparent that different times and rates of
pulse occurrence and sequencing for the turning on and off of
pulses to the electrodes 11 are contemplated by this invention,
when certain contractile sequences of acceptable tissue are
desired. It should further be understood that the manner of
coupling the electrodes 11 to the muscle structure is important,
and that other durations d and different pulse spacings p will be
required to achieve the desired contractile operation.
To facilitate the proper electrical coupling to the muscle, the
electrode shown in FIG. 3 was developed. The bipolar electrode is
referred to generally as 11, with the leads being designated 12+
and 12-. It has been determined electrode 11 of this design is
especially efficient for providing a stimulus current over an
adequate mass and at a sufficient depth in the detrusor muscle to
activate the neural conduction system innervating it. The
conductors 12+ and 12- are fashioned from flexible coils or wires
of Platinum-Iridium (Pt-Ir) wire or other suitable implantable
conductor such as carbon-impregnated cloth, etc. The conductors 12+
and 12- may be constructed from other metals such as tantalum,
gold, silver, and alloys of these metals with other metals. As
stated above, the receiver 10 components are encased or embedded in
a sterilizable, inert, nonirritating and nontoxic protective
insulating mass 13, preferably of a synthetic resinous material,
with only the conductors 12 leading to the muscle stimulating
electrodes 11 extending therefrom. These conductors 12 are
insulated by encasing them in a similar synthetic resinous
protective and insulating material, or by coating them with a
similar substance. Substances which operate both for the stimulator
10 and the wires 12, with the desired insulating characteristics,
are silicone rubber, silastic resins, tetrafluoroethylene polymers,
vinyl chloride and the like, and are suitable materials for these
purposes. Pure natural rubber may also be used. A first plurality
of conductive tabs 16 may be electrically connected to the wire
12+, and a second plurality of tabs 18 may be electrically coupled
to wire 12- for ease of connection. Each of the tabs contains an
aperture for use in fastening the electrode 11 to the muscle. This
will be described in more detail below. These tabs 16 and 18 are
constructed of the same material as the conductors 12+ and 12-. The
distances D1 and D2 can be varied and adjusted to accommodate
different muscle sizes. It should be noted also that greater or
fewer numbers of tabs 16 and 18 can be utilized both in parallel or
in series with the conductors 12+ and 12-. Further, for any
particular muscle stimulation, the number of tabs and electrical
interconnections may vary among the various electrodes 11. It will
be appreciated, of course, that a variety of electrode
configurations may be successfully employed in connection with the
present invention. For example, in lieu of the conductive tabs
referred to hereinabove, various areas of electrical insulation may
be bared from the conductor surface, and the electrodes effectively
coupled to the tissue in this fashion. Also, in FIG. 3 of the
drawings, a single electrode is illustrated, and it will be
appreciated that two, three, or more electrodes may be utilized,
and may be energized in sequential order, or may be energized as
multiple pairs. In some instances, it may be desirable to utilize
relatively large grid patterns which include a substantial number
of individual electrode elements.
A characteristic placement when three electrodes 11 are used is
illustrated in FIG. 4 on a bladder 20. In this arrangement, the
electrode 11 supplied with energy source V1 is applied at the
caudal-rostral midline of the dorsal surface, shown in dashed line,
and the two electrodes 11 energized by sources V2 and V3, are
placed near the lateral ligaments on the ventral surface. In this
arrangement, it is noted that the number of attachment points can
be varied to accommodate different sized bladders 20. In the
configuration shown, the ventral electrodes each utilize six tabs,
whereas the single dorsal electrode utilizes eight tabs. For this
arrangement, bladders of approximately 150 to 300 cc. capacities
can be accommodated. Additional electrodes 11 may also be added to
stimulate larger bladders.
In FIG. 5 there is shown a sectional view of a portion of the
bladder muscle 20, together with a portion of an electrode 11. Only
the 12+ wire together with the 14+ insulation is shown. In this
arrangement, there are three tabs 16, each having wires or thread
22 sewn through the apertures therein and for a predetermined depth
into the muscle. In this arrangement, the wires 22 are metal
sutures, and are inserted approximately 2 to 3 millimeters into the
bladder wall and tied to the holes in tabs 16. This arrangement
provides for electrical contact from the conductor 12+ into the
detrusor muscle. The electrodes 11 so designed and attached were
made of a flexible design to follow the contour of the bladder
during micturition. The wires 22 can be of the same material as the
electrode wires 12+ and 12-, or other suitable electrically
conductive materials. Once the electrodes are sutured to the
muscle, a thin sheet of insulating material, for instance,
silastic, is placed over the electrodes to prevent stimulation of
contiguous excitable structures. In FIG. 5, this insulation is
represented in cross section as element 24, and characteristically,
can be in the order of 0.005 inch in thickness.
Having considered the general operational system, and the
application of electrodes to the muscles, attention will next be
directed to FIG. 6 wherein there is shown a schematic block circuit
diagram of an implantable muscle stimulator deriving its
stimulation power from an external transmitter. The portion of the
stimulator 10 shown enclosed within dashed block 30 includes a
tuned resonant circuit 32, which characteristically can be
comprised of an inductor and a capacitor in a parallel-connected
resonant circuit. Such a circuit has the ability to store energy
for short periods of time and tends to act as an energy reservoir.
Further, the inductor of the tuned circuit 32 acts as an antenna,
for picking up pulses of radiofrequency energy from an external
high-power transmitter of conventional design (not shown), where
such energy is transmitted through layers of body tissue to the
tuned circuit 32. The tuned circuit 32 is coupled to a circuit
identified as rectifiers and filters 34 as indicated by arrow 36.
The signals provided by the tuned resonant circuit 32 are rectified
into DC signals by filtering out the radiofrequency and the DC
voltage so developed is applied at the output of the rectifiers and
filters 34. In this invention, the signals are directed on lines 38
to clocking and pulse circuits 40 wherein the signals applied from
lines 38 are converted to pulses and are alternatively applied to
lines 42, 44, and 46 in substantially nonsimultaneous order. The
signals provided on lines 38 are converted to pulses by means of
pulse generators, or multivibrators, of types available
commercially, and these pulses are applied to the bipolar
electrodes 42, 44, and 46 for durations determined by the clocking
circuitry. The clocking circuitry can be selected from various
types of circuit components and arrangements well known in the
prior art. Isolation elements I1, labeled 48; I2 labeled 50; and In
labeled 52, are provided for isolating the electrodes electrically.
Such isolation between electrodes can be provided for example by
isolation transformers, or by simple diode arrangements for
performing isolation as is well known. The signals provided from
the isolation elements are taken directly to the electrodes with
the wires being indicated by reference numeral 12, as previously
used. It can be seen that the function of the clocking and pulse
circuits 40 is to provide a planned application of signals to the
isolation elements 48, 50, and 52 in a manner similar to that
illustrated in FIG. 2. Only one of the bipolar lines 12 will carry
signals at any given time.
An alternative embodiment is illustrated in FIG 7, wherein there is
shown in schematic block diagram form an alternative implantable
muscle stimulator 10. In this arrangement, a plurality of power
sources indicated as PS1 labeled 54; PS2 labeled 56; and PSn
labeled 58, is utilized, with a separate one of the power sources
used for each of the bipolar electrodes 11. In this arrangement,
there is utilized a plurality of pulse generators, with pulse
generator 1, labeled 60, being coupled by line 62 to power source
PS1. In a similar manner, pulse generator 2, labeled 64, is coupled
by lines 66 to power source PS2. Finally, pulse generator n,
labeled 68, is coupled by lines 70 to PSn. The output signals from
the pulse generators 60, 64 and 68 are controlled by the clock
circuit 72 respectively. A clock circuit 72 can be any well-known
isolating clock circuitry, such as ring counters, or the like, used
to determine the pulse enabling sequence to each of the electrodes.
In this manner, the output line 74 from clock circuit 72 controls
pulse generator 1, a signal on line 76 controls pulse generator 2,7
and the signal on line 78 controls pulse generator n. The output
signals from the pulse generators 60, 64 and 68 are applied on
lines 12 in a nonsimultaneous arrangement as described above. It is
readily apparent that the duration of the pulses occurring on lines
74, 76 and 78 determine the duration d of the power pulses in
conjunction of the availability of energy signals on lines 62, 66
and 70, respectively. It is further apparent, that the time
duration between occurrences of signals on lines 74, 76 and 78 will
determine the elapsed time between the activating pulses available
on lines 12. Further, the duration of the count in clock circuit 72
until it completes the cycle will determine the duration d between
consecutive signals on any given line V1, V2, and Vn.
In FIG. 8 there is illustrated on characteristic pressure response
curve for the situation wherein a muscle is stimulated by the
simultaneous occurrence of three electrical signals. Application
thereby indicating that only partial voiding of the bladder has
occurred. In this figure, M denotes micturition.
FIG. 9 illustrates a characteristic pressure response obtained in a
bladder wherein pulses were applied nonsimultaneously through three
electrodes as described above. In this operation, it can be seen
that the intravesical pressure rise upon stimulus S application led
to a more complete bladder evacuation as indicated by a drop in
residual pressure following the termination of the application of
the stimulus S. Again, M denotes micturition.
Experimentation with the evacuation of the urinary bladder leads to
the conclusion that it is necessary to select the appropriate
application of electrical stimuli to effect a detrusor contraction
leading to sequential opening of the sphincters. Pressure increases
leading to sphincter opening are achieved in an optimum fashion
when the stimuli are nonsimultaneously applied via electrically
isolated bipolar electrodes to the detrusor muscle, while limiting
the current spread to surrounding excitable structures below their
stimulus threshold. In a specific example of the simultaneous
stimulation of three electrodes, as illustrated characteristically
in FIG. 8, experimental results yielded an intravesical pressure
rise to approximately 33 centimeters of water, but with only 20 cc.
of a 200 cc. bladder being voided. In the experimental operation,
there was no visible sign of current field spread observed, but due
to the poor voiding response, it is believed that there was current
spread to the pudendal nerve, thereby forcing the external
sphincter to contract. Further experimentation with the application
of sequential stimulating pulses, with a characteristic response
curve shown in FIG. 9, demonstrated that there was a sharp
intravesical pressure increase followed by rapid evacuation of the
entire capacity of the 200 cc. bladder with no sign of stimulus
spread. In FIG. 9, the sharp peaks in the pressure response curve
correspond to the pulsatile contractions of the bladder and
forceful streams from the urethra.
As indicated above, evacuation of the urinary bladder requires
appropriate application of the electrical stimuli to effect a
detrusor contraction, leading to sequential opening of the
sphincters. It has been determined that these contractile responses
are obtained when pulses are applied at a rate of approximately
10-40 per second with durations of approximately 0.5 to 5
milliseconds and amplitudes up to about 50 volts. The foregoing
mentioned experiments were conducted by applying bipolar pulses of
1-millisecond duration at a rate of 20 per second with an
approximate amplitude of 30 volts.
Since relatively large current fields are generated when
stimulating the detrusor muscle, a combination of insulating the
electrodes from the contiguous muscle structures, together with the
nonsimultaneous application of energizing signals to the electrodes
from electrically isolated outputs has been employed to restrict
the spread of current fields to excitable structures surrounding
the bladder. The nonsimultaneous application of pulses to the
electrodes attached to the muscle causes less spread than
simultaneous application of pulses thereto. This can clearly be
understood by considering that the stimuli applied to each
electrode are electrically independent and electrically isolated
from one another. If a point in the muscle equidistant from the
three electrodes is considered, the field generated at this point
by each electrode is identical if the electrodes are the same and
equal voltages are applied to them. Consequently, the application
of pulses to the electrodes simultaneously results in a field at
this point of approximately triple intensity, where three
electrodes are used, while nonsimultaneous application gives a
single field intensity occurring three times as often. Since the
surrounding tissue of concern contains rapidly accommodating nerve
fibers with low stimulus thresholds, the increase in frequency of
stimulus application to these fibers does not greatly affect their
function, but the lower current at this point helps the field of
strength to remain below simulus thresholds of the nerve fibers. If
a point nonequidistant from the electrodes is considered, the
contribution of each electrode to the current field will be
different and the total field somewhat less than that described
above. Sequencing results in decreases in the field at the point,
with this decrease being realized when changing from simultaneous
to nonsimultaneous stimulus application. A further decrease in the
contribution of each electrode to a distant current field is
realized by electrically insulating the electrodes from any
contiguous tissue other than the muscle to be stimulated, with this
insulation being accomplished by the placing of an insulating
material between the attached electrodes and the contiguous
structures. Further current field localization can be realized by
electrically isolating the electrode poles so that no current can
flow between them.
From the foregoing, it is clear that the various stated objectives
and purposes of the invention have been achieved by the apparatus
and method described. It is recognized that various alternations in
dimensions, circuit component selections, tolerances, and timing,
and the like, will become apparent to those skilled in the art
without departing from the spirit and scope of the invention.
Accordingly, what is intended to be protected by Letters Patent is
set forth in the appended claims.
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