GB2212924A - Penile tumescence monitor - Google Patents

Description

I- 1 NOCTURNAL PENILE TUMESCENCE MONITOR AM METHOD The present invention

relates to nocturnal penile tumescence monitors and more particularly to a nocturnal penile tumescence monitor and method that correlates penile tumescence with electrical signals for accurate measurement of any changes in tumescence over a given time period.

Studies on male impotence have shown that men with psychogenic impotence who have difficulty in reaching an erectile condition of the penis while awake, generally have normal erections while sleeping. The studies also show that men with organic impotencer whether awake or asleep, are incapable of developing a normal erection. As a result of these studies, the monitoring of penile tumescence during nocturnal periods has become one of the bases for diagnosing sexual impotency.

If nocturnal penile tumescence monitoring indicates that impotency may be due to psychological factors, an appropriate therapy program can be developed. However if nocturnal penile tumescence monitoring indicates that impotency may be due to organic problems then therapy is generally not effective as a remedy. Thus, nocturnal penile tumescence monitoring is also a basis for determining 22 1,2 9 2 4 2 - whether therapy will be helpful or futile in correcting male impotency.

The recognition that nocturnal penile tumescence monitoring is useful in diagnosing male erectile impotence has resulted in the development of various devices and techniques for conducting a penile tumescence monitoring operation.

One known device for monitoring nocturnal penile tumescence and rigidity as disclosed in U.S. Patent No. 4,,515,166, employs a cable that forms a noose which fits snugly about the penis. One end of the cable joins a sprocket assembly that drives a potentiometer. Changes in penile circumference are expected to affect the dimensions of the noose causing the cable to move the sprocket assembly and drive the potentiometer to produce a corresponding electrical response. The disclosed cable and sprocket arrangement is cumbersome to use and the mechanical play inherent in such device may result in inaccurate data. Consequently there is a need to make frequent calibrations of the sprocket and drive assembly.

It is thus desirable to provide a device for monitoring penile tumescence during nocturnal periods which can be easily installed on a patient, is comfortable to use and provides accurate data.

I- -9 1 - 3 -1 r Among the several objects of the invention may be noted the provision of a novel penile tumescence monitort a novel penile tumescence monitor that is relatively comfortable for a patient to use during nocturnal periods, is easily installed and can be disposed of after use# a novel nocturnal penile tumescence monitor which utilizes electronic signals to provide highly accurate measurements and repeatable datar and a novel method for measuring penile. tumescence.

Other objects and features of the invention will be in part apparent and in part pointed out hereinafter.

The nocturnal penile tumescence monitor, in accordance with the present invention, includes a flexible elastomeric sleeve which encircles the circumference of the penis. During a tumescent event the sleeve changes in circumference. A sensing mechanism is located within the sleeve and is responsive to changes in the sleeve circumference so as to generate an output signal indicative of the circumference change. A control mechanism acquires and processes the output signals that it receives from the sensing mechanism.

1 In the accompanying drawings, in which several embodiments of the invention are illustrated:

FIG. 1 is a sectional view of a penile tumescence monitor incorporating one embodiment of the present invention; FIG. 2 is a simplified schematic perspective view of a portion thereof; FIG. 3 is a plan view of the conductive surface thereof; FIG. 4 is a detail of a portion of the control circuit thereof; FIG. 5 is a schematic diagram of the control circuit thereof; FIG. 6 shows the pattern of the output signals from the circuit of FIG. 4; FIG. 7 is a simplified schematic perspective view thereof as used during a monitoring operation; FIG. 8 is an enlarged sectional view of another embodiment thereof; FIG. 9 is an end view thereof; FIG. 10 is an enlarged fragmentary perspective view thereof partly shown in section; A I FIGS. 11 and 12 are simplified schematic sectional views thereof for two different tumescent conditions; FIG. 13 is a schematic diagram of the control circuit thereof; andr FIG. 14 is a detail of a portion of the control circuit thereof.

Referring to the drawings, a nocturnal penile tumescence (hereinafter NPT) monitor incorporating one embodiment of the invention is generally indicated by the reference number 10 in Fig. 1.

The NPT monitor 10 comprises a detection means 12 which can be fitted onto a first predetermined section of a penis 14 to detect changes in penile circumference. Preferably a second detection means 16 (Fig. 7), identical to the detection means 12, is fitted onto a second predetermined section of- the penis 14 to detect changes in penile circumference at the -second location. The detection means 12 and 16 generate electrical signals that are transmitted to a control apparatus 18 to provide data for conversion,, storage and display.

Referring to Figs. 1 and 2, the detection means 12 includes an expandable and contractable detection member 20 arranged in spiral configuration. The detection member 20 comprises a nonconductive base strip of plastic film 22 which can be formed of polyester, for example.

Referring to Figs. 2 and 3, two independent toothlike conductive patterns 24 and 26 are printed, plated. etchedr coated or otherwise formed on a surface 28 of the base strip 22. The tooth-like conductive patterns 24 and 26 extend along respective opposite edges 30 and 31 of the base strip 22y separated by a portion of the surface 28 that is nonconductive.

As most clearly shown in Fig. 3, the tooth-like pattern 24 has peak portions 34 and valley portions 36, whereas the tooth-like pattern 26 has peak portions 38 and valley portions 40. The peak portions 34, 38 and the valley portions 36, 40 are of an equal width and represent incremental steps of predetermined dimension that can be counted to determine the exact increase or decrease in circumference of the detection member 20. However the conductive patterns 24 and 26 are out of phase by approximately one half the width of a peak or valley portion.

A conductive wiper 42 is provided at a terminal end 44 of the base strip 22 on an opposite surface 46 to align with the conductive pattern 24 when the detection member 20 is in its spiral configuration. Similarly a corresponding conductive wiper 48 is provided alongside the wiper 42 on P 1 the surface 46 to align with the conductive pattern 26. Conductive leads 50 and 52 extend from the respective wipers 42 and 48 and are insulated from the conductive patterns 24 and 26.

A conductive lead 54 at the terminal end 44 extends from a common conductive surface portion 56 that is continuous with the conductive patterns 24 and 26.

A casing 58 (Fig. 1) of soft pliable elastic material, preferably formed of latex, envelops the detection member 20. The casing is sealed in any suitable known manner.

The NPT monitor 10 is preferably used during nocturnal periods. Before a patient goes to sleep, the detection means 12 and 16 are slipped onto prescribed penile locations such as shown in Fig. 7. The penis 14 should be in a flaccid condition when the detection means 12 and 16 are installed.

The detection means 12 and 16 can be made in selected predetermined nominal sizes or a single universal size can- be constructed. However, to exemplify the magnitudes being dealt with the detection member 20 can have a thickness of approximately 5 mils,, a width of approximately 3/8 inches and a length of approximately 10 inches. The casing 58 can have a thickness of approximately 0.001 to 0.002 inches.The expandable and contractable characteristics of the detection means 12 and 16 are based on the thickness and elastic coefficient of the casing 58 as well as the thickness and type of material used to form the casing 58 and the detection member 20.

After the detection means 12, for example, is positioned on the penis 14, a predetermined electrical current is fed to the detection member 20 through the conductive leads 50 and 52.

Any expansion or contraction of the encased detection member 20 will result in relative movement between the wipers 42 and 48 and their respective conductive patterns 24 and 26.

The wipers 42 and 48 are of a predetermined size to permit conductive engagement with the peak portions 34 and 38 of the conductive patterns 24 and 26. However there is no conductive engagement between the wipers 42, 48 and the valley portions 36, 40 of the conductive patterns 24 and 26, since the wipers engage the nonconductive surface 28 that aligns with the valley portions 36, 40.

Thus when a current is applied across the leads 50 and 54, a pulse signal will be generated when the wiper 42 is in contact with a peak portion 34 of conductive pattern 24, whereas no signal is generated when the wiper 42 is at a valley portion 36.

In a similar fashion, the wiper 48 cooperates with G.

the peak portion 38 and valley portion 40 of conductive pattern 26 to generate a pulse signal across the leads 52 and 54.

As previously stated, the peak portions 34, 38 and the valley portions 36, 40 represent incremental steps of predetermined dimension that can be counted to determine the exact increase or decrease in circumference of the detection member 20. The out of phase arrangement of the conductive patterns 24, 26 permit a determination of whether the pulse signals generated by the detection member 20 represent an increase or decrease in penile circumference. The signals can also be timed and charted to provide a display of the tumescent condition of a patient over a predetermined time period.

The control apparatus 18 for processing the pulse signals of the detection member 20 is shown in schematic f orm in Fig. 5. The control apparatus 18 includes an input conditioning circuit 62, a microprocessor 64, a clock 66, a data storage means 68, a communications port 70 and a battery back up 72.

Referring to Fig. 4, the input conditioning circuit 62 includes filters 74 and 76, also known as Schmitt Triggers, sold by National Semiconductor under part number 74HC14. The filter 78 is further enhanced by a resistor 80 and a capacitor 82. The resistor 80 can be approximately 1 kiloohm and the capacitor 82 approximately.002 microfarads. Exclusive OR's 84 and 86, such as sold under part number 74EC86 by National Semiconductor complete the conditioning circuit.

The conditioning circuit 62 helps clarify and eliminate noise from the electrical signals generated by the detection member 20 and enhances their characteristic square wave configuration. The conditioning circuit 62 also generates a clock signal and a signal which indicates whether the pulse signals generated by the detection member 20 represent an expansion or contraction of the penile circumference which accompanies a change in tumescence.

Referring to Fig. 6, the wave forms A and B represent examples of output signals from the respective conductive patterns 24 and 26 after being conditioned by the conditioning circuit 62. The CLK wave form represents clock pulses furnished by the conditioning circuit 62.

The microcomputer 64 is adapted to activate upon the sensing of the CLK signal from the input conditioning circuit 62. Upon receiving the CLK signal, the microcomputer 64 will determine the status of the waveforms A and B coming from the conditioning circuit 62.

The function of the microcomputer 64 in determining the status of the waveforms A and B can be understood with reference to Fig. 13. The waveforms A and B normally assume i 0 one of four possible combinations as noted at points 90r 92r 94 and 96. For exampler at point 90 the waveform A is high and the waveform B is low. At point 92 the waveform A is low and the waveform B is high. At point 94 both waveforms A and B are low. At point 96 both waveforms A and B are high.

If signals A and B are high-low (90) or low-high (92), the detection member 20 is increasing in circumference. If signals A and B are low-low (94) or highhigh (96), the detection member 20 is decreasing in circumference.

The microcomputer 64, by examining the state of the waveforms A and B, can determine if the detection member 20 is increasing or decreasing in circumference and, by counting the CLK pulses can simultaneously determine the number of pulses involved. The CLK pulse can be correlated to the number of peak and valley portions on the conductive patterns 24 and 26 and hence. can be translated into direct measurement.

The microcomputer 64 is adapted to store, by count, in its memory, data reflecting an increase or decrease in the circumference of the detection member 20. For example, upon receipt of a CLK signal, the microcomputer will examine the waveforms A and B and if they indicate increasing circumference, as noted above, will add a unit to the data storage 68. At the next CLK signal, the microcomputer 64 will examine the A and B signals and if the circumference of the detection member 20 is still increasing, a second unit will be added to the data storage 68. Convers ely, if the A and B waveforms indicate that the circumference of the detection member 20 is decreasing, a unit will be subtracted from the data storage 68 and so on.

The clock 66 supplies the microcomputer 64 with data indicating the actual or real time that each CLK pulse is received. Thus, changes in penile tumescence events can be correlated with the actual time that such changes occurred during the monitoring operation to aid in diagnosing a patient's condition.

The battery backup 72 provides an independent source of power to the microcomputer 64, the clock 66 and the data storage 68 to maintain the memory of each of these units when the main power is shut off. Since it may be necessary to conduct an examination over a prolonged period of time, the battery backup 72 enables the control circuit 60 to be turned off when the patient is awake or removes the detection means 12 and 16. Preferably, the battery backup 72 has a capacity of 30 hours or more.

The communication port 70 provides a means for retrieving the data stored in the data storage 68. For example, a printer, chart recorder or CRT system may be k.

utilized to convert the data accumulated during a monitoring operation to a real time display record.

Another embodiment of the NPT monitor is generally indicated by the reference number 100 in Fig. 8.

The NPT monitor 100 comprises a detection means 102 which can be fitted onto the penis 14 in a manner similar to that described for the detection means 12. The detection means 102 generates electrical signals that are transmitted to a control apparatus 104, shown schematically in Fig. 13.

Referring to Figs. 8-10, the detection means 102 comprises an expandable and contractable detection member 106 arranged in spiral configuration. The detection member 106 comprises a non-conductive base strip of film 108 which can be formed of plastic coated uniformly on one surface with an electrically conductive material 110. An electrical terminal 112 (Fig. 9) provided near an end 113 of the conductive surface 110 connects with a lead wire 114. An opposite uncoated nonconductive face 116 of the base film 108 is provided with a projecting conductive wiper element 118 that connects to a lead wire 120. The lead wire 120 extends from the base film 108 without making electrical contact with the conductive surface 110.

Spaced nonconductive bearing strips 122 and 124 (Figs. 8 and 10) of a suitable low friction polyolefin material, such as sold under the trademark Tyvek, are bonded 1 - or otherwise secured to the conductive surface 110 along the elongated side edges of the base strip 108. A channel 126 of predetermined size is thus defined between the bearing strips 122 and 124 to accommodate the wiper element 118 when the detection member 106 is wrapped or coiled upon itself in spiral fashion as shown in Figs. 8-10.

The bearing strips 122 and 124 reduce friction between the respective layers of the detection member 106 and guide the wiper element 118.

A casing 130 (Figs. 8 and 9) of soft pliable elastic material similar to that of the casing 56t envelops the detection member 106. The casing 130 is sealed by bonding or adhering the confronting edges 132 and 134 in any suitable known manner.

The detection means 102 is formed of materials having dimensional magnitudes similar to those described for the detection means 12. It should also be noted that the nonconductive bearing strips 122 and 124 can be approximately 3-4 mils thick,, i.e.j, the strips 122 and 124 have an elevation of approximately 3-4 mils from the conductive surface 110.

The NPT monitor 100 is used in a manner similar to that previously described f or the NPT monitor 10. For example,, the detection means 102 can be placed onto one section of the penis 14 corresponding to the location of the 1 i R 1 detection means 12 in Fig. 7. Another detection means (not shown) identical to the detection means 102 can be placed on another section of the penis 14 corresponding to the location of the detection means 16 in Fig. 7.

After the detection means 102, for example, is positioned on the penis 14, a predetermined electrical current is fed to the detection member 106 through the conductive leads 114 and 120.

The detection means 102 will diametrically expand or contract in response to any changes in the tumescent condition of the penis 14.

A resistance reading can thus be obtained corresponding to the flaccid condition of the penis 14 based upon the electrical distance between the lead wires 114 and 120.

The electrical distance between the lead wires 114 and 120 is a measure of the circumferential paths along the conductive surface 110 from the conductive wiper element 118 to the terminal 112. As the tumescent condition of the penis 14 increases, the inside circumference of the detection member 106 increases. Correspondingly, the electrical distance between the conductive wiper element 118 and the terminal 112 increases, thereby increasing the electrical resistance between the lead wires 114 and 120.

For example, a flaccid penile diameter is indicated - j 1 16 - along a horizontal reference line 140 in Fig. 11 and the diameter of an erectile penis is indicated along the horizontal reference line 140 in Fig. 12. The horizontal reference line 140 aligns with a free end 142 of the detection member 106.

Referring to Fig. 11, the conductive wiper element 118 is at a first position defined by an angle A from the reference line 140. The angle A is an approximate first angular displacement between the end portions 113 and 142 of the detection member _106. The first angular displacement A corresponds to a first circumferential distance between the conductive wiper element 118 and the terminal 112 and is electrically represented by a first resistance magnitude.

Referring to Fig. 12, the conductive wiper element 118 is at a second position relative to that shown in Fig. 11,, defined by an angle B, from the reference line 140. The angle B is an approximate second angular displacement between the end portions 113 and 142 of the detection member 106. The second angular displacement B corresponds to a second circumferential distance between the conductive wiper element 118 and the terminal 112 and is electrically represented by a second resistance magnitude.

It should be noted that the reference line 140 is assumed to be fixed at a horizontal orientation for illustrative purposes only. The angles A & B are also used A 4 1 1 __17 - for illustrative purposes only and are not intended to represent that the detection member 106 expands or contracts relative to a fixed reference line. Actual expansion and contraction of the detection member 106 is not -relative to any fixed reference line since the detection member 106 is movable with respect to the casing 130., The difference between the angles A and B is analagous to a difference in predetermined resistance magnitudes. The resistance difference represented by the difference between angle A and angle B corresponds to a difference in circumferential distance between the conductive wiper element 118 and the terminal 112, for the tumescent conditions of the penis 14 as shown in Figs. 11 and 12.

Thus the difference between the first and second resistance magnitudes can be interpreted to provide a readout of the difference between the first circumferential distance of Fig. 11 and the second circumferential distance of Fig. 12. Furthermore any difference between the flaccid penile diameter and an erectile penis diameter can be determined by the resistance measurements at the particular time of the tumescent event.

The resistance value at the time of the tumescent event can be measured, stored, displayed or converted to other data as desired. The resistance value corresponds to k 1.1 - 18 the penile circumference at a particular time, and when compared with the flaccid penile circumference will indicate whether any changes in tumescence have occurred during the nocturnal period.

The control apparatus 104 for processing the resistance signals of the detection member 106 is shown in schematic form in Fig. 13. The control apparatus 104 includes an input bridge amplifier 150, an analog to digital converter 152, a microprocessor 154p a clock 156, a data storage means 158, a communications port 160 and a battery backup 162.

Referring to Fig. 14r the input bridge amplifier 150 is of a known circuit arrangement that transmits the resis-tance signals from the detection member 106 to the analog to digital converter 152. The converted digital signals are operated on by the microprocessor 154 using known programming to provide storable data for the data storage 158 and convertable data for the communications por 160 to display the changes in tumescence that occur over a given time period.

The clock 156 correlates the tumescent conditions to real time occurrence and the battery backup 162 provides reserve power when needed.

35-71 or X 4.

A

Claims (1)

1. CLAIMS b.

   C.

   The a. said b. said i.

   A penile tumescence monitor comprising: a flexible elastomeric sleeve adapted for releasably encircling a penis about the circumference thereof, whereby changes in the penile circumference during a tumescene event result in changes in the circumference of said sleeve; sensing means within said sleeve responsive to the changes in the circumference of said sleeve and constructed and arranged to generate an output signal indicative of the circumference change; and, control means operatively connected to said sensing means for acquisition and processing of said output signals from said sensing means.

   monitor in accordance with Claim 1, wherein: sleeve includes: i. an envelope of a soft elastomeric material; ii. a strip of flexible material constructed and arranged to form a coil-like member within said envelope; and, sensing means includes: electrical resistive means on said flexible strip; ii. wiper means on said flexible strip adapted to slideably engage said resistive means and make electrical circuit contact therewith; iii. electrical conduit means in communication with said resistive means and said wiper means; 4 1 1 - 20 C. said ouput signal being a direct function of the electrical resistance between said electrical conduit means.

   The monitor in accordance with Claim 2, wherein: said electrical resistance means include first and second conducting surfaces having spaced.conductive pads thereon; said wiper means include first and second contact members constructed and arranged to operatively engage said first and second conductive surfaces respectively; C. said output signal being two electrical signals which are functions of the interaction of said first conducting surface and first contact member and of said second conducting surface and second contact member.

   4. The monitor in accordance with any preceding claim, wherein said control means include interface means for providing communication with peripheral equipment.

   5. The monitor in accordance with any preceding claim, wherein said control means, in cooperation with said sensing means, further includes means for recording of penile tumescence data throughout the penile tumescence event.

   6. A penile tumescence monitor, substantially as described with reference to, and as shown in, the accompanying drawings. ' Published 1989 atThe PatentOffice. State House, 6671 High Holborn. LondonWCIR4TP- Further copies maybe obtained from The Patent office Wes Bmnch, St Mary Cray, OrpingwD- Kent BPS 3RD. Printed by Multiplex techniques ltd. St MW7 Cray, Kent, Con. 1/87 t t