U.S. patent number 3,640,284 [Application Number 05/000,762] was granted by the patent office on 1972-02-08 for apparatus for electrotherapy of the pubococcygeus.
Invention is credited to Philip A. De Langis.
United States Patent |
3,640,284 |
De Langis |
February 8, 1972 |
APPARATUS FOR ELECTROTHERAPY OF THE PUBOCOCCYGEUS
Abstract
Apparatus for electrotherapy of the pubococcygeus muscle group
of a female. The apparatus includes an electrode member contoured
for insertion into the vagina. Spaced electrodes on the member are
supplied with a carrier signal comprising shaped, bipolar pulses in
the frequency range of from 20 Hz. to 8 kHz., the signal being
carrier modulated at a rate of between 0.2 Hz. and 10 Hz. The
bipolar pulses exercise striated muscle, while the low-frequency
modulation contracts smooth muscle and prevents continuous tetany.
A condom-type vaginometer permits measurement of vaginal volume and
of vaginal pressure resulting from contraction of pubococcygeus
muscles.
Inventors: |
De Langis; Philip A. (Palos
Verdes Estates, CA) |
Family
ID: |
21692922 |
Appl.
No.: |
05/000,762 |
Filed: |
January 5, 1970 |
Current U.S.
Class: |
607/71; 607/64;
607/74; 600/591 |
Current CPC
Class: |
A61H
21/00 (20130101); A61B 5/1073 (20130101); A61N
1/0524 (20130101); A61N 1/36007 (20130101); A61B
5/4337 (20130101) |
Current International
Class: |
A61B
5/103 (20060101); A61B 5/03 (20060101); A61N
1/36 (20060101); A61N 1/05 (20060101); A61n
001/06 () |
Field of
Search: |
;128/2,24.1,24.4,407,408,422 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Chamblee; Hugh R.
Claims
I claim:
1. Apparatus for electrotherapy including, a pair of spaced
electrodes; means developing a carrier wave which is substantially
a sine wave having a frequency within the range of 150 Hz. to 1
kHz., means amplitude modulating said carrier wave with a
modulating signal having a frequency substantially less than said
carrier frequency and producing a series of recurrent bipolar
pulses with each of said pulses having a duration established by
said modulating signal and consisting of variations in its
amplitude at said carrier wave frequency from a maximum positive
value, to a zero value to a maximum negative value, to a zero value
to a maximum positive value, and so forth; and means connected to
said amplitude modulating means and continuously modifying said
maximum positive values and said maximum minimum values such that
they become progressively larger at a slower rate during initial
development of each of said pulses than during subsequent
development such that each of said bipolar pulses is defined by a
slowly rising portion followed by a portion of substantially
constant amplitude; and means applying said bipolar pulses to said
electrodes.
2. Apparatus as set forth in claim 1 in which modulating frequency
is in the range of 150 Hz. to 1 kHz.
3. Apparatus as set forth in claim 1 in which said modulating
frequency is within the range of 0.5 Hz. to 1 kHz.
4. Apparatus as defined in claim 1 including means for limiting the
current flow to said electrodes to a value which does not exceed
250 milliamperes.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an apparatus for electrotherapy of
the pubococcygeus muscle group of a female, and to a vaginometer
permitting measurement of vaginal volume and of vaginal pressure
resulting from contraction of pelvic muscles.
2. Description of the Prior Art
Primary muscular support for the female urogenital area is provided
by two muscle groups, the iliococcygeus and the pubococcygeus. If
the pubococcygeus muscles are atonic or functioning inadequately, a
number of urogenital anomalies such as urinary stress incontinence
and uterine prolapse may result. Moreover, poor functioning of the
pubococcygeus muscles is a significant cause of female frigidity or
sexual inadequacy.
Proper adjustment to sexual relations by married persons is a
significant element of happiness in marriage. Unsatisfactory
adjustment can, and frequently does lead to unhappiness, to adverse
affects on personality, and in many cases, to divorce. Therefore,
it is important that married persons learn to perform their
respective sexual roles as well as possible, and that physicians
have the means available to assist them in doing so. To this end,
awareness of the role played by the pubococcygeus muscles in female
frigidity is of considerable importance.
In typical cases of apparent female frigidity, the strength of the
pubococcygeus has been tested and the muscles found to be
functioning at less than about 10 percent of their optimum. In the
past, gynecologists have treated this problem by perscribing a
series of exercises to be performed by the female to tone up the
pubococcygeus muscles. These exercises included voluntary
contraction of the muscles in the midpelvic area, and particularly
of the muscles surrounding the middle one-third of the vagina. The
result of such exercise was a very marked improvement in sexual
appreciation and response of the female. Often patients reported
that they were feeling more sexually, and many indicated that they
were experiencing vaginal orgasms for the first time in their
lives.
Similar marked improvement in other urogenital anomalies have been
reported as a result of exercise of the pubococcygeus muscle. For
example, women who experience urinary incontinence found that after
a program of exercise of the pubococcygeus muscle they were able to
control bladder release to a degree not previously possible.
Electrotherapy has been used extensively in the past to exercise
muscles of various parts of the body in cases where natural muscle
function has been lost or diminished. In such cases, the production
of painless, graduated muscular exercise by electric stimulation
reproduces the physical and chemical phenomenon connected with
normal muscular work. But despite the widespread use of
electrotherapy for other parts of the body, there have been
virtually no reports of the application of such therapy to the
female urogenital area.
SUMMARY OF THE INVENTION
In accordance with the present invention, there is provided an
apparatus for electrotherapy of the female pubococcygeus muscle
group. The apparatus includes an electrode member which is
contoured for insertion into the vagina and by means of which a
programmed electrical signal may be applied to cause exercise of
both striated and smooth pubococcygeus muscles. Use of the
inventive apparatus results in significant improvement in the tone,
strength and functioning of the pubococcygeus muscles. Benefits of
such use including significant reduction in female frigidity,
relief from urinary incontinence difficulties and improvement of
other urogenital anomalies.
The present electrotherapy apparatus includes electrical circuitry
which provides a carrier signal comprising shaped bipolar pulses
and having a carrier frequency in the range of from 20 Hz. to 8
kHz., the signal being carrier modulated at a rate of between 0.2
Hz. and 10 Hz. The bipolar pulses exercise striated muscles, and
are shaped so that a relatively low-current initially is applied to
the muscle, with a higher current being applied once the muscle has
contracted. The low-frequency pulse modulation exercises smooth
muscle and prevents continuous tetany.
To measure the condition and performance of the pubococcygeus
muscle, there is also disclosed a novel condom-type vaginometer
which permits measurement of the vaginal volume and of the pressure
resulting from contraction of pubococcygeus muscles. The
vaginometer comprises a generally cylindrical condom holder having
a shank region over which the open end of a condom is stretched. An
O-ring and an annular cover maintain the condom on the holder.
In use, the condom portion of the vaginometer is inserted in the
vagina and filled with water via an axial opening through the
condom holder. The vaginal volume may be measured by determining
the amount of water required to fill the condom. By connecting a
manometer to the vaginometer, the pressure resulting from
contraction of pubococcygeus muscles may be measured directly.
Thus, it is an object of the present invention to provide apparatus
for electrotherapy of the female pubococcygeus muscles.
Another object of the present invention is to provide an
electrotherapy apparatus including an electrode member contoured
for insertion into the vagina, and means for supplying a programmed
electrical signal to the electrode member for exercise of muscles
in the pelvic region.
It is another object of the present invention to provide an
electrotherapy apparatus including circuitry to supply a carrier
signal comprising shaped bipolar pulses of a relatively high
frequency, the carrier signal being modulated at a relatively low
frequency.
Yet another object of the present invention is to provide an
apparatus for electrotherapy of the pubococcygeus muscle group and
including means for exercising both striated and smooth muscle and
for preventing continuous tetany.
Still another object of the present invention is to provide an
apparatus for the electrotherapy of pubococcygeus muscles including
means for applying a relatively low current to the muscles before
they have contracted and a relatively larger current
thereafter.
A further object of the present invention is to provide a novel
vaginometer.
It is a further object of the present invention to provide a
vaginometer of the condom-type, useful for measuring vaginal volume
and vaginal pressure resulting from contraction of pubococcygeus
muscles.
BRIEF DESCRIPTION OF THE DRAWINGS
Still other objects, features and attendant advantages of the
present invention will become apparent to those skilled in the art
from a description of the preferred embodiments constructed in
accordance herewith, taken in conjunction with the accompanying
drawings, wherein like numerals designate like parts in the several
figures, and wherein:
FIG. 1 is a perspective view of an electrode member contoured for
insertion into the vagina, and useful as part of the inventive
apparatus for electrotherapy of the pubococcygeus muscle group;
FIG. 2 is an electrical block diagram showing typical circuitry
useful for providing a programmed electrical signal to the
electrode member of FIG. 1;
FIG. 2a graphically illustrates a typical waveform produced by the
circuitry of FIG. 2; and
FIG. 3 is a perspective view of a novel condom-type vaginometer
useful for measuring vaginal volume and vaginal pressure resulting
from contraction of pubococcygeus muscles.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to the drawings, and particularly to FIGS. 1 and 2
thereof, there is shown a preferred embodiment of the inventive
apparatus for electrotherapy of the pubococcygeus muscle group. In
general, the apparatus comprises a generally tubular electrode
member 10 (FIG. 1) which is contoured for insertion into the
vagina. Member 10 includes a pair of longitudinally spaced,
circumferential electrodes 11 and 12 to which is supplied a
programmed electrical signal from the circuitry 13 of FIG. 2.
Referring in greater detail to FIG. 1, electrode member 10 includes
a closed end 14 of generally hemispherical shape, and an open end
15 which is outwardly flared. Member 10 preferably is constructed
of plastic or other smooth, electrically nonconductive material.
Electrodes 11 and 12 are flush with the exterior surface of member
10, and are positioned with electrode 11 adjacent end 14 and
electrode 12 spaced approximately one-third of the way back toward
end 15. The interior 16 of tubular member 10 houses a pair of
electrode wires 17 and 18 which are respectively connected to
electrodes 11 and 12 interiorly thereof. Electrode wires 17 and 18
extend out through flared end 16, and are connected to the
electrical circuitry of FIG. 2, as described below.
For effective electrotherapy of the pubococcygeus muscle group, it
is desirable to supply to electrodes 11 and 12 a signal having both
high-frequency and low-frequency components. Illustrative circuitry
for providing such a signal is shown in FIG. 2. Referring thereto,
circuitry 13 includes an oscillator 20 having a frequency in the
range of from 20 Hz. to 8 kHz., and preferably in the range of from
150 Hz. to 1 kHz. Bipolar output pulses from oscillator 20 are
shaped by a high-frequency signal processor 21, typically a passive
filter network, which provides a gradual rise time to each pulse.
As will be described below, this shaping is desirable to provide
initially low current to the striated muscles of the pubococcygeus,
followed by a relatively higher current once these muscles have
contracted. The output of oscillator 20 also is shaped by a
low-frequency signal processor 22 which in effect introduces a
low-frequency carrier modulation in the frequency range of from 0.2
to 10 Hz., and preferably in the range of from 0.5 to 1 Hz.
The shaped and modulated signals from processors 21 and 22 are
combined in a conventional summing amplifier 23 to provide on a
line 24 a carrier signal comprising shaped bipolar pulses and
having a frequency in the range of from 20 Hz. to 8 kHz., the
carrier signal being modulated at a low frequency in the range of
from 0.2 to 10 Hz. This signal on line 24 is amplified by an
automatic gain control (AGC) amplifier 25 and by a power amplifier
26, and the amplified signal provided via a terminal 27 to one of
electrodes 11 and 12 of member 10. The other of electrodes 11 and
12 is connected to a terminal 28 associated with a constant current
detector 29.
The average current flowing between electrodes 11 and 12 is sensed
by constant current detector 29 which provides along a line 30 a
signal indicative of the sensed current level. The signal on line
30 is supplied to an automatic gain control (AGC) driver 31 which
in turn controls the gain of AGC amplifier 25 in a manner so as to
maintain the average current between electrodes 11 and 12 at a
generally constant level. A manual amplitude control 32 associated
with AGC driver 31 permits operator selection of the average
current level provided to electrode member 10. Preferably, average
current levels below about 250 milliamperes may be employed. A
power supply 33 provides DC power to operate oscillator 20 and the
other components of circuitry 13.
The circuitry of FIG. 2 is illustrative only, and other electronics
may be used to produce the programmed electrical signal to
electrode member 10. However, the excitation signal provided to
electrodes 11 and 12 should include both high-frequency and
low-frequency components. The reason for this is that the pelvic
area muscle group includes both striated and smooth muscle, both of
which must be considered in any process of pelvic rehabilitation.
Experiments have proved that effective, painless vaginal muscle
stimulation requires bipolar pulses of relatively high frequency
(20 Hz. to 8 kHz.) to contract striated muscle and relatively low
frequency (0.2 to 10 Hz.) bipolar pulses to contract the smooth
muscle. The optimum frequencies for these bipolar pulses vary
somewhat from patient to patient, but generally are in the range of
from 150 Hz. to 1 kHz. for the high-frequency component and from
0.5 to 1 Hz. for the low-frequency component. As mentioned
hereinabove, the low-frequency component may be introduced by
carrier modulating a high-frequency signal comprising bipolar
pulses.
The wave shape of the bipolar pulses comprising the relatively
high-frequency component of the excitation signal to electrode
member 10 is not critical. In fact, both sine wave and square wave
signals have been found to work effectively. However, for optimum
exercise of striated muscle, it is desirable that the pulses be
shaped to provide an initially low current, followed by a
considerably higher current as the muscle starts to contract.
Similarly, the shape of the low-frequency carrier modulation is not
critical. However, a relatively slow rise time again is desirable
to provide an initially low current to the smooth muscles, followed
by a higher current when these muscles begin to contract. FIG. 2a
shows a typical signal produces by the circuit of FIG. 2; the shape
of the low-frequency modulation is clearly evident. However,
signals having waveshapes other than that illustrated in FIG. 2a
may be used effectively with the inventive apparatus.
The low-frequency component of the excitation signal, in addition
to causing contraction of smooth muscle, also functions to avoid
continuous tetany of the striated muscles. This is desirable, since
if the striated muscle were continuously contracted by the
high-frequency component, the muscle would tend to accommodate or
relax, and little or no effective exercise of the striated muscle
would result despite continued application of the bipolar pulses.
By interrupting or modulating the high frequency carrier at a
low-frequency rate, such continuous tetany is avoided, and the
striated muscle has no chance to accommodate or relax.
The shaping of the high- and low-frequency signal components also
serves the function of eliminating very high-frequency components
(in excess of several thousand Hz.) which develop heat within the
tissue and/or stimulate the pain receptors. This insures that the
electrotherapy will be painless to the patient. Moreover, the
low-frequency component allows use of the present apparatus on both
innervated and denervated muscles.
In operation, electrode member 10 is inserted into the vagina of
the patient, possibly using a lubricant such as water. Electrode
wires 17 and 18 are connected to terminals 27 and 28 of circuitry
13 (FIG. 2), and the manual amplitude control 32 is given to the
patient. The patient increases the amplitude of the excitation
signal from circuitry 13 to a point where pubococcygeus muscle
contractions occur. Because of accommodation, the patient typically
will increase the amplitude of the excitation signal from time to
time during the treatment. Optimum muscle exercise was found to
occur when electrodes 11 and 12 were positioned over the motor
points of the pubococcygeus.
Significant improvement in the tone, strength and functioning of
the pubococcygeus muscle group was found to result from regular use
of the inventive electrotherapy apparatus. To facilitate actual
quantitative measurement of this improvement, the vaginometer of
FIG. 3 was developed. This device permits measurement of the
vaginal volume and also of the vaginal pressure resulting when the
pubococcygeus muscles are contracted.
Referring to FIG. 3, vaginomenter 40 comprises a generally
cylindrical condom holder 41 having a vaginal shank region 42 of
relatively small diameter and a flared body region 43 of relatively
larger diameter. An axial opening 44 extends through condom holder
41. Attached rearwardly of condom holder 41 is a disc-shaped back
plater 45 having a central opening 46. Vaginometer 40 also includes
an O-ring 47 and an annular cover 48 of plastic, hard rubber or the
like. The diameter of central opening 49 in cover 48 is slightly
larger than the outer diameter of shank region 42 of condom holder
41.
As illustrated in FIG. 3, the band 50 of a condom 51 is stretched
over shank region 42 of holder 41, and the condom threaded through
O-ring 47 and annular cover 48 . The O-ring 47 and cover 48 then
are positioned about shank region 42 to secure the condom open end
52 to holder 41. Cover 48 prevents condom 51 from forming an
aneurism outside the vagina which would give erroneous pressure and
volume readings. Further, the vaginal orifice shank 42 is provided
to assist in holding the vaginometer in the vagina, and to
eliminate false pressure readings which might otherwise result
should the patient contract the vaginal orifice.
When vaginometer 40 is assembled as described, condom 51 may be
filled with water or other fluid supplied underpressure from a
syringe (not shown) via an inlet tube 53 (FIG. 3), a valve 54 and a
tube 55 which communicate with the interior of condom 51 via axial
openings 44 and 46. For pressure measurement, a manometer (not
shown) is connected for fluid communication with the interior of
condom 51 via a line 56, valve 54 and tube 55. Valve 54 permits
selection of whether vaginometer 40 is connected to inlet tube 53,
so as to permit filling of condom 51, or to line 56, so as to
facilitate manometer measurement of vaginal pressure.
In operation, the condom portion 51 of vaginometer 40 is inserted
into the vagina with shank portion 42 of condom holder 41 extending
into the vaginal orifice. With valve 54 positioned to provide fluid
communication between tubes 53 and 55, condom 51 may be filled with
warm water from a syringe (not shown). Typically, the condom is
unfused with water until a tare pressure of 30 millimeters of
mercury (mm. Hg.) is observed. The patient then is asked to
contract rapidly the vaginal and abdominal muscles. When this
exercise is stopped, the condom water pressure again is checked. If
the vaginometer pressure has changed, more water is infused and the
exercise repeated until a constant pressure is obtained. This
insures complete vaginal filling. The amount of water required to
fill condom 51 then is indicative of the vaginal volume.
To determine vaginal pressure resulting from contraction of
pubococcygeus muscles, vaginometer 40 is inserted in the vagina and
filled with fluid as described above. The patient is asked to
contract the vaginal muscles only, with the lungs empty. During the
measurement, the abdomen may be palpated to ensure that the
abdominal muscles are not contracting. To obtain the vaginal
pressure reading, valve 54 is turned to provide fluid communication
between the manometer line 56 and the interior of condom 51, via
tube 55. Typically, the patient is asked to maintain this
pubococcygeus contraction for about 10 seconds while a manometer
pressure reading is taken.
The significant improvement is muscle tone, strength and
functioning of the pubococcygeus resulting from treatment with the
inventive electrotherapy apparatus is illustrated by the statistics
in the following Table I, derived from actual patient case
histories. In this table, the period of treatment in weeks is
indicated for each patient, as well as the total number of
treatments. Typically, individual treatments were of about one-half
hour in duration. The vaginal volume and vaginal pressure resulting
from contraction of pubococcygeus muscles prior to the treatment
period is indicated, and the corresponding vaginal volume and
pressure values measured at the end of the treatment period also
are listed. Note that as a control, Table 1 includes data for two
patients (Case Nos. 6 and 7) who received no treatment.
##SPC1##
As is evident from Table I, in each case, a very significant
increase in vaginal pressure resulted at the end of the treatment
period. This increase in pressure is indicative of the improved
pubococcygeus muscle tone, strength and functioning resulting from
use of the inventive apparatus. Typically, patients noted a
significant increase in sexual interest and activity after
treatment with the inventive electrotherapy apparatus. Moreover, in
cases of urinary incontinence and other female urogenital
anomalies, definite improvements also resulted when the
pubococcygeus muscles were exercised and toned up by use of the
apparatus described herein.
Although reference is made herein for use of the apparatus in
connection with the vagina of a female, it is to be understood that
the apparatus may also be used for the male or female as a rectal
probe or electrode.
While the invention has been described with respect to several
physical embodiments constructed in accordance therewith, it will
be apparent to those skilled in the art that various modifications
and improvements may be made without departing from the scope and
spirit of the invention.
* * * * *