US 3640284 A
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.
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llnited States Patent De Langis [151 smmm 1 Feh.%,1972
 APPARATUS FOR ELECTROTHERAPY OF THE IPUBOCOCCYGEUS 21 Appl. No.: 762
 U.S.Cl. ..l28/422, 128/2 S, 128/408 3,056,409 10/1962 Edwards ..l28/422 Primary Examiner-Hugh R. Chamblee Attorney-Lyon & Lyon [5 7] 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  int. Cl. ..A61n 01/06 20 to 8 KHZ, the Signal being carrier modulated at a r 58 Field of Search ..12s/2, 24.1,24.4, 407,408, of between and 10 The bipolar Pulses exercise 123/422 striated muscle, while the low-frequency modulation contracts smooth muscle and prevents continuous tetany. A condom- 56] Reiereuces Cited type vaginometer permits measurement of vaginal volume and of vaginal pressure resulting from contraction of pubococ- UNITED STATES PATENTS yg s mus le 3,403,684 10/1968 Stiebel et a1. 128/407 4 Claims, 4 Drawing Figures POWER 217 iii/f AMP 27 7'0 24 Z ELECT/Q0055 [0W I fiesagfgf 25 5/ flR06E'550/Q 28 .92
22 MIA/VAL 2p AMPL I7'UOE CUII/TROL ER 29 cgfr t in rs 3/ CONSTANT CURRENT 0575670/2 PATENTED rsa 81972 EHEET W W 2 INVENTOR.
APPARATUS FOR ELECTROTIIERAPY OF THE PUBOCOCCYGEUS BACKGROUND OF THE INVENTION 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 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 onethird 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 OFTI-IE INVENTION muscles. Use of the inventive apparatus results in significant improvement in the tone, strength and functioning of the pub'ococcygeus muscles. Benefits of such use including significant reduction in female frigidity, relief from urinary incontinence difiiculties 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. to8 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 lowfrequency 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 tlne 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 (FIG. 1) which is contoured for insertion into the vagina. Member 10 includes a pair of Iongitudinally 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 l1 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 l1 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-frequem cy 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 lowfrequency 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 temninal 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 highfrequency 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 striatedmuscle and relatively low frequency (0.2 to l0 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 Hz. to l kHz. for the high-frequency component and from 0.5 to l 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 lowfrequency 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 acconunodate or relax.
The shaping of the highand low-frequency signal compornents also serves the function of eliminating very highfrequency 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 Oring 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.
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 As illustrated in FIG. 3, the band 50 of a condom 51 is 5 prior to the treatment period isindicated, and the correspondstretched over shank region 42 of holder 41, and the condom ing vaginal volume and pressure values measured at the end of threaded thro gh O-rmg 47 and ann lar cover 48 The O-rmg the treatment period also are listed. Note that as a control, 47 and cover 48 are Posmoned about Shank 8 42 to Table 1 includes data for two patients (Case Nos. 6 and 7) secure the condom open end 52 to holder 41. Cover 48 h i d no t t nt,
TABLE I Pre-treatment Post-treatment Period of Patient treatment, Number of Volume, Vaginal Volumev Vaginal case no. (weeks) treatments (1111.) pressure (mL) prcssult 16 22 130 5 125 11s 12 35 150 0 140 110 s 150 *is 150 140 4 11 280 3 2x5 17 3. 5 10 150 *3 1511 *50 4 0 160 4 11m 5 4 0 150 *5 155 *5 *Cornbined vaginal and abdominal pressure.
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 530 (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 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 1 to fill condom 5 1 then is indicative of the vaginal volume.
To determine vaginal pressure resulting from contraction of pubococcygeus muscles, vaginometer 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 ll, derived from actual paticnt case histories. In this table, the period of treatment in As is evident from Table l, 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.
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 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 varia tions 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 i 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.
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