Electrical stimulator

3,403,684

Oct 1, 1968

A. I. STIEBEL ET AL

ELECTRICAL STIMULATOR

Filed Nov. 23, 1964

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3,403,684

Patented Oct. 1, 1968

United States Patent Office

3,403,684 ELECTRICAL STIMULATOR

Ariel I. Stiebel, 17540 Stoepel Ave., and Seymour. A.

Lippmann, 16859 Griggs Ave., both of Detroit, Mich. _ 48221

Filed Nov. 23, 1964, Ser. No. 413,039

Ciaims. (Cl. 128—407)

ABSTRACT OF THE DISCLOSURE 10

An electrical stimulator for supplying electrical stimulating pulses to preselected areas of a living body which is formed of an elongated body having a bulbous portion at one end and a generally flat portion at the end _lginterconnected by a generally narrow rod-like portion. The flat portion is adapted to position a plurality of electrodes formed on the bulbous end within a cavity in the living 'body. Also, the flat portion may contain a source of electrical energy and a means for controlling the opera- ₂θ tion of the device. The bulbous end contains a pulse timing circuit for controlling pulses of energy from the source of electrical energy to the plurality of electrodes.

Background and summary of the invention

This invention relates generally to an electrical stimulator device and more particularly to a method and apparatus for applying electrical energy to the tissues of a living body to promote the physiological and psy- 30 chological processes thereof.

It is well known that many of the physiological and psychological processes of animal and human bodies are accomplished through the electrical stimulation of the tissues thereof. Thus, many organs and nerves of the 35 body, both human and animal, function partially or totally through the reception of an electrical impulse from signal generating centers of the brain or other portions of the body. While the precise operation of this system of electrical “transmiters” and “receivers” is not clearly known; 40 the general characteristics of these signals have been sufficiently discovered to predict the reaction of the body to these signals.

It has been found that a stimulation of certain nerve centers of the body will occur when repetitive electrical 45 pulses are applied to the tissues of certain concentrated areas. One such area is the region of the prostate gland and, by electrical stimulation of the tissues therearound, an artificial signal may be created and used for the amelioration of sexual incompetence or impotence. This 50 function becomes extremely important in those cases where naturally generated stimuli have ceased to occur in the body. In the case of the normal person, it appears that the upper mid brain contains an integrating mechanism which is sensitive to the concentration of hormones 55 in the blood. In the case where these hormones are present in amounts above a certain level, these certain specific sensory stimuli excite reflexly a basic neural mechanism to cause the erection of the penis. In the case of the impotent person, the stimuli or “electrical signal” which di- 60 rects the muscles or tissues of the area about the genitals are not transmitted or in certain cases are not received, thereby creating a situation of sexual impotence.

As stated above, it has been found that by stimulating the tissues about area of the prostate gland and the nerves 65 positioned in proximity thereto with an electrical signal of a specified period, duration and magnitude, the vasodilator and vasoconstrictor fibers in the penis are stimulated to react. The reaction of both the dilator and constrictor fibers creates offsetting reactions on the arterial 70 muscles of the penis with the net result that the arteries are neither dilated nor constricted. However, it is be2 lieved that the efforts of the vasoconstrictor fibers are frustrated and the muscles are paralyzed through repeated pulsing of the nerves about the prostate gland with the net result that the action of the vasodilator fibers prevails. Thus the arterial vessels of the penis are caused to dilate thereby permitting the inrush of arterial blood into the vessels, causing tumescence or erection of the penis. It has been found through the prolonged pulsing of the neural region about the prostrate that the erection may be sustained for a considerable period of time.

The unity of the device has been demonstrated by inserting a stimulator device, which was constructed according to the principles of the present invention, into the anus thereby positioning a pair of electrodes in the area of the prostate gland of a user suffering from sexual impotence. Through the application of pulses of a form to be hereinafter described to the tissues adjacent the prostate gland, an erection was achieved. The device is seen to have further utility in the field of animal husbandry and in this regard, a device constructed accordding to the principles of the present invention was inserted into the colon of dogs adjacent the area of the prostate, and, through electrical pulses of the type used in the first demonstration, an erection of the penis was achieved.

This application of pulses to the tissues about the vicinity of the prostate in utilizing the principles of the present invention is achieved by means of a generally elongated capsule that is suitably placed in the colon adjacent the area of the prostate gland by insertion of the device through the rectum. The device is provided with a pair of spaced electrodes which are properly positioned by means of the configuration of the device and, more specifically, by the proper choice of the length of the device. In the use of the stimulator, the level of current flow through the adjacent tissues has been found to be extremely critical to produce the desired result and it is this threshold current which varies with the different users and from time to time with the same user. It has been found that insufficient current flow through the tissues or voltage drop across the electrodes has produced no reaction while an over stimulation through electrical pulses of a larger magnitude than the threshold magnitude resulted in undesirable or unpleasant sensations. Thus a threshold or critical value in voltage or current is necessary to achieve desired results.

It is contemplated within the scope of the invention that the device may be of the type having an electromagnetic output, as for example a coil, producing a magnetic field of the proper periodicy, duration and magnitude wherein the tissues form the secondary winding for a transformer effect. Moreover, the preferred embodiment is illustrated as having a battery supply for the electrical circuitry thereof, it is contemplated that an external supply connected through a thin cable passing to the exterior of the body may be provided, thereby allowing one to use the device from normal house power.

While the discussion will be cast in the field of ameliorating sexual impotence, it is to be understood that the invention may be used in other fields wherein malfunctions of the body may be corrected by the passage of electrical pulses or current through tissues of the body. As an example, it is contemplated that the invention may be used in situations where it is impossible for certain persons to void the bladder, as in the case of paraplegic and related neurogenic bladders. In this case it is contemplated that electrical stimulation of certain tissues and muscles of the bladder may be achieved to dilate the opening to the bladder and thus empty the contents thereof.

Accordingly, it is one object of the present invention to

3,403,684 provide an improved method and apparatus for electrically stimulating tissues of humans and lower animals.

It is another object of the present invention to provide a method and apparatus for electrically stimulating vasodilatory and vasoconstrictor fibers of humans and lower animals.

It is another object of the present invention to provide a method and apparatus for electrically stimulating tissues of humans and lower animals to cause tumescence of the genital organs thereof.

It is still another object of the present invention to provide an improved electrical stimulator device for producing electrical pulses of a given period, duration and magnitude to be applied to the tissues of humans or lower animals.

It is still another object of the present invention to provide an improved electrical stimulator which is compact and capable of being received into the cavities of the body of humans and lower animals.

It is a further object of the fresent invention to provide an improved electrical stimulator of the type described which is easily positioned within the body.

It is still a further object of the present invention to provide an improved circuit for an electrical stimulator of the type described which is compact and low in power consumption.

It is a further object of the present invention to provide an improved method and apparatus for use on animals which greatly facilitates certain phases of the field of animal husbandry.

It is another object of the present invention to provide an improved electrical stimulator which has an inherent characteristic of properly positioning the device for use and is comfortable to the user.

Further objects, features, and advantages of this invention will become apparent from a consideration of the following description, the appended claims and the accompanying drawings in which:

FIGURE 1 is a cross-sectional view of an electrical stimulator device incorporating certain principles of the present invention;

FIG. 2 is an end view of FIG. 1 as viewed along a line parallel to the arrow A thereof; and

FIG. 3 is a schematic diagram illustrating a preferred pulsing circuit which may be incorporated into the device of FIG. 1.

Referring now to the drawings, and particularly to FIGS. 1 and 2, there is illustrated an electrical stimulator device 10 which is adapted to be inserted into the rectum of a human or lower animal. The stimulator device 10 comprises a bulbous end 12 which is adapted to house an electrical circuit 14 in a receptacle cavity 15 of the end 12 and a generally flat portion 16 spaced therefrom and adapted to house a suitable power supply 18, such as the battery illustrated. The bulbous portion 12 and flat portion 16 are rigidly connected together and generally axially aligned by means of an intermediate round conduit portion 22 which is shown as being integrally formed with the portions 12, 16. The outer housing of the stimulator device 10 is fabricated of any suitable plastic or other type of material which may be easily cleaned and which is generally impervious to the fluids of the body thereby hermetically sealing the electrical circuit 14 and power supply 18 from harmful fluids.

As was stated above, the stimulator device 10 is adapted to be inserted into the rectum and the bulbous portion 12 is positioned in the colon generally in the area of the prostate gland with the sphincter muscle gripping the conduit portion 22. With the device 10 in this position, the flat portion 16 will protrude beyond the rectum and be positioned generally between the cheeks of the buttocks. As was further stated above, it is necessary that the electrodes be properly positioned to localize the stimulation to the area of the prostate and thus the flat portion is pro4 vided with a shoulder area 26 and the bulbous portion 12 is provided with a second portion area 28 to preclude the device from slipping wholly into the colon and assure that the device is sufficiently inserted therein, respectively. The portion 16 is formed of a flat configuration, as illustrated in FIG. 2, to provide comfort to the user and also to properly angularly position the bulbous portion 12, as will be hereinafter explained.

The bulbous portion 12 is provided with a pair of generally ring shaped, spaced electrodes 30, 32, which are suitably molded into the material of the bulbous portion 12 and a pair of conductor studs 34, 36 projecting from the soldered to the electrodes 30, 32 with the outer ends connected to the output leads of the electrical circuit 14. The spacing between the electrodes is chosen to provide the proper potential gradient in the tissues of the body spanning the electrodes, the resistance of the tissues varying from approximately 50 to 500 ohms. While the electrodes 30, 32 have been illustrated as being circular, it has been found that a plurality of segmental electrodes may be provided in the area of the periphery of the bulbous portion 12 to provide a greater localization of the current flow through the tissues. The segmental electrodes would be embedded in a manner similar to that illustrated in FIG. 1. In this way the electrical energy supplied from the electrodes to the surrounding tissue and in the area of the prostate gland would be extremely localized thereby achieving a greater degree of satisfactory results.

With the segmented type of electrode, it is necessary that the bulbous portion 12 be properly oriented in the angular direction and it is one of the functions of the flat portion 16 to properly orient the segmental electrodes relative to the area of the prostate gland. It is seen that, by properly positioning the conduit portion in the anus, the buttocks will tend to maintain the flat portion in a position which will orient the bulbous portion relative to the prostate gland.

The flat portion 16 has been provided with a cover member 40 which is suitably attached to an upper area of the flat portion 16 and serves to fully enclose the receptable cavity 42 which receives the battery member 18. The battery may be of any suitable voltage, such as from 3 to 9 volts, and is chosen according to the voltage and current requirements of the electrical circuit 14 while remaining small enough to fit into the battery portion of the receptacle cavity 42. The end walls of the receptacle cavity has been provided with a pair of electrical contactors 44, 46 which have mounted thereon a pair of spring biased contact elements 48 and 50, respectively, which are spaced from and horizontally oppose each other to receive the case backing 52 and electrode tip 54 of the battery member 18. The contactor elements 44, 46 may be embedded in the material of flat portion 16 or otherwise suitably fastened thereto.

One end of the flat portion 16 is apertured, as at 56, to receive the shank portion 58 of a control member 60 having a control button 62 thereon. The control member 60 may be of any suitable type which has the capability of opening and closing the power supply circuit and also controlling the resistance of a potentiometer (not shown) contained within the control 60. The button 62 may be actuated by a push-and-release operation to provide an “on-off” action and also by angularly rotating the button 62 to provide control of the resistance of the potentiometer. A suitable retaining nut 64 is provided to the rigidly fix member 60 and button 62 in proper position with respect to the cavity 42.

The conduit portion 22 has been formed with a generally elongated tubular passageway 68 which is adapted to receive a plurality of pairs of conductors 70, 72, which interconnect the power supply 18 and control member 60 with the electrical circuit 14. The conductors 70, 72 are situated in a slot formed in the lower portion of receptacle cavity 42 and it is to be noted that one of the con3.403.684 ductors of the pair 70 is suitably connected to the contactor element 44 while the other conductor of the pair 70 is connected to the “on-off switch” portion of the control element 60. A conductor 74 has been provided between contactor element 46 and the other side of the switch portion control member 60 to complete the circuit between the battery 18 and the switch. The two conductors of pair 72 have been connected to the potentiometer portion of control member 60 and are suitably connected to circuit 14 to control the output of circuit 14 to the electrode members 30, 32.

With the bulbous portion 12 properly positioned in the colon adjacent the organ which is desired to be stimulated, such as the tissue in the area of the prostate gland, the switch 62 is turned on and the potentiometer portion of control element 60 is adjusted to achieve a current magnitude which is approximately at the threshold level described above. In the specific case where the device is utilized to stimulate an erection in the user, it has been found that the potential difference between the electrodes 30, 32 must rise from zero to the threshold level in a short period of time, maintain the high level for a specified period and then diminish to zero in a short time.

Experiments have shown that the desired physiological effects are achieved if the time for the initial rise in voltage is less than 100 milliseconds and in the preferred embodiment it has been found that 10 microseconds achieves the desired results. The duration of the high level conduction has been found to be greater than .001 second and the preferred embodiment contemplates utilizing 80 milliseconds and the decay time for lowering the voltage has been found to be best when it corresponds to the rise time. The period of pulsing the electrodes, the cyclic rate, has been found to achieve the best results when it is in the range of .3 to 4.0 seconds, and generally the period should be in the range of 1 to 1.5 seconds per optimum results. As a further consideration, the desired results have been found to be achieved when the “off” time for the pulse is greater than 2.5 milliseconds. In properly polarizing the electrodes, the electrode 30 disposed at a point furthest from the anus is of a negative polarity while the electrode 32 closest to the anus is of a positive polarity. Thus the flow of current will be from electrode 32, through the adjacent tissue and into electrode 30. It has been found that the voltage and current levels must be held to within close limits as determined by the individual user if the device is to be effective. These limits depend upon certain conditions of the individual using the device, and it has been found that below the critical level of voltage, or current flow, there is no reaction while beyond this critical level an unpleasant sensation results. It has further been found that the critical or threshold level, which is generally in the range of .5 to 5.0 volts per inch, varies with usage and the physiological and psychological condition of the user. In order to provide this variability of the voltage level and current flow, the button 62 has been provided with the capability of being rotated to adjust the potentiometer incorporated into control member 60.

The above pulsing operation may be performed by any type of an electrical circuit and the invention contemplates utilizing a variety of different types of oscillators such as multivibrators, and relaxation, phase shift and other oscillators which have the capability of producing the desired high rise time, substantially level pulsing of the electrodes 30, 32. One such contemplated circuit, forming the preferred circuit for the present invention, is illustrated in FIG. 3. The source of energy 18 is connected to the pair of electrodes 30, 32 by means of an “on-off” switch 78, the switch incorporated into control member 60, and a silicon controlled switch 80 connected in series therewith. The silicon controlled switch 80 controls the flow of current from battery 18 to electrode 32 and a suitable potentiometer 82, which is the potentiometer in control member 60, is provided to control the amplitude of the pulses provided by silicon control switch 80.

The silicon control switch 80 includes an anode electrode 84, and a cathode electrode 87, which are con5 nected in series between the battery 18 and electrode 32, and a gate electrode 86 which is utilized to receive a signal for firing the silicon controlled switch 80. The firing signal for the gate electrode 86 is provided through a circuit including a resistor 88 which has been connected in series with a normally nonconducting NPN transistor 98. The resistor 88 is connected to conductor 78 at one end thereof, the other end being connected to gate electrode 86 and transistor 98. The transistor 98 is connected to a conductor 90 which completes the circuit back to the ]5 battery 18. Thus, with the switch 76 in the closed position and the transistor 98 biased on, the potential at junction 130 is lowered to a less positive voltage relative to conductor 78 and the silicon controlled switch 80 is fired to the conducting state. Thus, the current flow will be from 20 battery 18, through conductor 78, silicon control switch 80, variable potentiometer 82 through to electrode 32. The body tissue between electrodes 30 and 32 will conduct the current to electrode 30, and is well known, the tissue has a resistance of between 50 and 500 ohms depending 25 on the age and condition of the user and the spacing between the electrodes 30 and 32. The current flows from electrode 30 back to the other side of battery 18 through conductor 90. It is to be noted that the conductor 78 to the right of switch 76 corresponds to one of the conduc3Q tors of pair 70, while the conductor between silicon controlled switch 80 and potentiometer 82 and between potentiometer 82 and electrode 32 form the pair of conductors 72.

A relaxation oscillator circuit 94 has been provided to 35 fire the silicon controlled switch circuit and comprises generally a unijunction transistor 96 which is adapted to provide a firing pulse to transistor 98 through conductor 100. An RC timing circuit is connected across battery supply 18 between conductors 78 and 90 and comprises 40 a variable resistor 104 and a capacitor 106 connected in series. The charging time of capacitor 106 from battery 18 is determined by the values of resistor 104 and capacitor 106, as is known in the art, and the resistor 104 is preadjusted during manufacture according to the characteristics of unijunction transistor 96 and is fixed prior to 45 the assembly of the stimulator 10. The emitter 108 of unijunction transistor 96 is connected between the junction of resistor 104 and capacitor 106, and base one 110 is connected through dropping resistor 112 to conductor 90. Base two 114 is connected to conductor 78 through 50 conductor 116 thus providing a high resistance circuit between conductors 78 and 90 through base one and base two of unijunction transistor 96. As the critical voltage is reached across capacitor 106, unijunction transistor 96 fires, providing a low resistance path between discharg55 ing capacitor 106 and resistor 112, and current is conducted from emitter 108 to base one 110. While unijunction transistor 96 is conducting, current is conducted from battery 18 through switch 76, resistor 104 through emitter 108, base one 110, and through resistor 112. The 60 discharge current of capacitor 106 flows through emitter 108, base one 110, and resistor 112.

The potential of the junction 120 between base one 110 and resistor 112 is raised to a positive level according to the value of resistor 112 and thus feeds a positive pulse to 65 the base 100 of NPN transistor 98 through a current limiting resistor 122. Thus, the current flows through resistor 88, the collector-emitter circuit of transistor 98 to conductor 90. With the extremely low impedence of the collector emitter circuit of transistor 98, the voltage level 70 of the junction 130 between resistor 88 and gate electrode 86 is lowered to a point very near the potential of conductor 90, thereby placing a firing signal on the gate electrode 86. In this way the silicon controlled switch 80 is fired and current commences to flow between electrodes 75 30,32.

3,403,684

As the capacitor 106 discharges through the emitter base circuit of unijunction transistor 96, the voltage at the emitter electrode starts to decrease. At the critical-cutoff value, the transistor 96 ceases to conduct and turns off transistor 98 and, accordingly, silicon controlled switch 80. With the unijunction transistor 96 cut off, the capacitor starts to recharge and the cycle is repeated.

In operation, the circuit is closed by closing switch 76, and current begins to flow from battery 18 through conductor 78 to capacitor 106 through resistor 104. The capacitor 106 is charged to a critical voltage which determines the firing of unijunction transistor 96, thereby causing NPN transistor 98 to conduct and lowering the voltage at junction 130. With the lowering of the potential at junction 130, the gate electrode 86 is fed a pulse which fires the silicon controlled switch 80 until such time as the charge on capacitor 106 drops to a level which cuts off unijunction transistor 96 thereby changing NPN transistor 98 to the nonconductive state. While the circuit 14 has been illustrated with silicon controlled switch 80 as the controlling element, it is to be understood that a transistor may be used as a gate amplifier or other types of semiconductor elements may be utilized.

In the operation of the overall device, the bulbous portion 12 is inserted into the anus to a point wherein the anal sphincter grasps the conduit portion 22 thereby positioning the electrodes 30, 32 in an area adjacent the prostate gland. The “on-off” button 62 is actuated and the button 62 is turned to adjust the level of current flowing between electrodes 30, 32 until the desired reaction occurs. As the current flows between the electrodes 30, 32 and through the tissues adjacent the prostate gland, the constricting and dilating muscles in the arteries of the penis are activated to cause the simultaneous constricting and dilating of the genital arteries. However, as stated above, the constricting muscles tend to become frustrated and paralyzed thereby allowing the dilating muscles to control and cause an erection of the penis. It is to be noted that the device may be retained in the colon to sustain the erection, or the button may be turned off or the device removed when it is desired that the erection subside.

While it will be apparent that the embodiment of the invention herein disclosed is well calculated to fulfill the objects of the invention, it will be appreciated that the invention is susceptible to modification, variation and change without departing from the proper scope or fair meaning of the subjoined claims. For example, an indicating means may be provided on the exterior periphery of the stimulator 10 to allow the user to orient the device in either of two 180 degree positions relative to a vertical axis through the flat portion 16. Such an indicating device could be a projection integrally formed with the upper left end of flat portion 16 thereby indicating to the user the relative position of the electrodes 30, 32 within the body. As a further consideration, it is contemplated within the scope of the invention that the polarity of the electrodes may be reversed in manufacture or a suitable reversing switch, as is well known in the art, may be provided to be accessible to the user. Also, the resistor 104 may be made accessible from the exterior of the stimulator 10 to allow the user to vary the period of the pulses which are being applied to the tissues by electrodes 30, 32. As is readily seen from the foregoing description, the device may be easily used without the necessity of an operation for implanting electrodes.