USOO9180284B2

(12) United States Patent (10) Patent No.: US 9,180.284 B2

LaVoisier (45) Date of Patent: Nov. 10, 2015
(54) DEVICE AND METHOD FOR MEASURING USPC .................................................... 607/39, 143
AND TREATING THE RIGIDITY AND See application file for complete search history.
ERECTION OF A PENIS AND
ARTERAL-VENOUS FLOWS
(56) References Cited
(71) Applicant: Pierre Lavoisier, Rasteau (FR) U.S. PATENT DOCUMENTS
(72) Inventor: Pierre Lavoisier, Rasteau (FR) 5, 192.271 A 3, 1993 Kalb et al.
5,692,520 A 12/1997 Lavoisier
(*) Notice: Subject to any disclaimer, the term of this (Continued)
patent is extended or adjusted under 35
U.S.C. 154(b) by 241 days. FOREIGN PATENT DOCUMENTS
(21) Appl. No.: 13/728,242 DE 102004023966 A 12/2005
EP 1350465. A 10, 2003
(22) Filed: Dec. 27, 2012 JP 2006149566. A 6, 2006
WO 96.20753. A T 1996
(65) Prior Publication Data WO 98.38.914 A 9, 1998

US 2013/O116742 A1 May 9, 2013 Primary Examiner — Christopher D Koharski

Related U.S. Application Data Assistant Examiner — Michael Carey
(74) Attorney, Agent, or Firm — Young & Thompson
(62) Division of application No. 12/435,592, filed on May
5, 2009, now abandoned.
(57) ABSTRACT
(60) Provisional application No. 61/050,318, filed on May
5, 2008. The invention relates to a method for measuring the strength
of the ischiocavernous muscles of a patient, the method being
(51) Int. Cl. performed during an erection of the penis and providing a
A6IN I/IS (2006.01) measuring and/or rehabilitation device configured to deter
A61N L/00 (2006.01) mine the strength of the ischiocavernous muscles and com
(Continued) prising at least one sensor, placing the sensor around the penis
(52) U.S. Cl. of the patient, measuring the variation of the intracavernous
CPC ................ A61N I/00 (2013.01); A61 B 5/4393 pressure, contracting the ischiocavernous muscles, and
(2013.01); A61B5/486 (2013.01); A61H checking that the contraction causes elevation in intracarv
9/0078 (2013.01); A61H 19/32 (2013.01); ernous pressure so as to ensure that the accurate muscles are
A61N I/0452 (2013.01); A61N I/0472 contracted, where if the intracavernous pressure is elevated,
(2013.01); A61N I/0521 (2013.01); A61N ischiocavernous muscles are contracted during the contrac
I/36007 (2013.01); A61N I/36107 (2013.01); tion. The invention relates also to a method for treating and
A61 B 5/026 (2013.01); A61 B 5/02422 rehabilitating the ischiocaVernous muscles comprising a step
(2013.01); A61 H 220 1/165 (2013.01); A61 H of implementing the method for measuring the strength of the
220.1/5071 (2013.01) ischiocavernous muscles and a step of voluntarily contracting
the ischiocavernous muscles.
(58) Field of Classification Search
CPC ........... A61N 1/36007; A61N 1/36107; A61N
1 FO521 14 Claims, 4 Drawing Sheets
 US 9,180.284 B2
Page 2

(51) Int. Cl. (56) References Cited

A6 IN L/36 (2006.01)
A61N L/05 (2006.01) U.S. PATENT DOCUMENTS
3CO 3.08: 5,899,875 A
7,006,870 B1*
5/1999 Millot et al.
2/2006 Whitehurst et al. ............ 6O7/39
A6 IN L/04 (2006.01) 2004/0039328 A1 2/2004 Henley
A6H 9/00 (2006.01) 2007/0255333 A1* 11/2007 Giftakis et al. ................. 6O7/39
A61 B 5/024 (2006.01)
A61 B 5/026 (2006.01) * cited by examiner
U.S. Patent Nov. 10, 2015 Sheet 1 of 4 US 9,180.284 B2

Fig. 1
U.S. Patent Nov. 10, 2015 Sheet 2 of 4 US 9,180.284 B2

Fig. 2
U.S. Patent Nov. 10, 2015 Sheet 3 of 4 US 9,180.284 B2
U.S. Patent Nov. 10, 2015 Sheet 4 of 4 US 9,180.284 B2

^/
 US 9, 180,284 B2
1. 2
DEVICE AND METHOD FOR MEASURING The measuring method consists of measuring the maxi
AND TREATING THE RIGIDITY AND mum contraction (Pmax), the pressure gradient (delta Pand
ERECTION OF A PENIS AND mean delta), the Surface under the curve objectifying the
ARTERAL-VENOUS FLOWS muscular work of each contraction, the number of peaks and
the width of each peak.
The present invention relates to a method for measuring The measuring method consists of measuring the ischio
and treating the rigidity and erection of a penis and arterial cavernosus muscle (IC) fatigue by measuring the angle (C).
venous flows as well as a device for implementing this The measuring method consists of measuring the peaks of
method.
Measurements taken by the device are performed either 10
the ischiocavernosus muscles (IC) contractions and the varia
while the patient sleeps or during the day and allow, according tions in pulse pressure (PP) while maintaining stable pressure
inside the sensor whatever the variation in the volume of the
to the results obtained, the cause of erectile dysfunctions to be penis.
determined and their progression to be controlled.
Also, the measuring device that is the object of the inven The method for treating the ischiocavernosus muscles (IC)
tion allows patient rehabilitation in the case of premature 15 of a patient with either erectile dysfunction or premature
ejaculation and/or erectile dysfunction to be monitored and ejaculation or both, said patient having been diagnosed
controlled. thanks to the measurement of erections taken both day and
Measuring the nocturnal erection of the penis, in order to night, said measurements consisting of measurements of the
be able to disassociate organic impotence from psychogenic strength of the ischiocavernosus muscles (IC) causing the
impotence, is known. Patients with organic impotence do not rigidity of the penis (P) of the patient and of the arterial and
have erections during the day or during paradoxical sleep, venous variation in the corpus cavernosum ensuring the erec
while psychogenic patients have erections during sleep but tion of the penis (P), said method consists of:
not during the daytime. Placing a sensor comprising means for receiving the intra
The method for measuring the strength of the ischiocaver cavernous pressure (ICP) and pressure variations of a
nosus muscles (IC) causing the rigidity of the penis (P) of a 25 penis (P), means for electro stimulating the ischiocaver
patient and for measuring the variation in arterial and venous nosus muscles (IC), and at least one transducer inte
flows ensuring the erection of the penis (P) of the patient grated into or offset from the sensor allowing the pres
consists of Sure signal issued from the means for receiving the
Placing a sensor around the penis (P) comprising means to pressure to be transformed into an electrical signal,
receive the intracavernous pressure (ICP) and pressure 30 And connecting the sensor to a housing comprising means
variations of the penis (P), and at least one transducer for amplifying and recording the signal from the trans
integrated into or offset from the sensor allowing the ducer, means for analyzing the signal by a microcontrol
pressure signal issued from the means for receiving the ler allowing the electro stimulation to be controlled as a
pressure to be transformed into an electrical signal, function of the fatigue state of the ischiocavernosus
And connecting the sensor to a housing comprising means 35 muscles (IC) and for controlling the muscular rehabili
for amplifying and recording the signal from the trans tation through sound, visual or tactile patterns indicating
ducer, means for analyzing the signal by a microcontrol to the patient the intensity, duration and muscle contrac
ler allowing the fatigue state of the ischiocavernosus tion to be produced and the duration of the rest period
muscles (IC) to be measured and the variations in muscle between two contractions.
strength of the ischiocavernosus muscles (IC) to be mea 40 The method for treating a patient with erectile dysfunction
Sured. or premature ejaculation comprises electro stimulation means
The measuring method consists of measuring the varia that are constituted of electrodes controlled by a microcon
tions in intracavernous pressure (ICP) of the penis (P) in order troller and by the patient in order to vary the intensity.
to quantify the detumescence, tumescence and rigidity of the The method for treating a patient with erectile dysfunction
penis (P) during both day and night. 45 comprises a measuring device that establishes the diagnosis
The measuring method consists of measuring the intracav of organic impotence during the night.
ernous pressure (ICP) that progressively reaches the mean The method for treating a patient with erectile dysfunction
systolic pressure of the penis (P). is specially indicated for patients presenting a muscular
The measuring method consists of measuring the increase pathology with a normal vascular phase, but also for those
in arterial inflow in the corpus cavernosum (CC) and the 50 with a mixed vascular pathology of arterial or venous and
reduction in venous outflow during the vascular phase, which muscular origin.
is the first penis (P) erection phase. The method for treating a patient with erectile dysfunction
The measuring method consists of measuring the varia consists of placing the patient on an examination bed or on his
tions in the contraction and rigidity of the ischiocavernosus bed, the electrodes are connected to a housing and are placed
muscles (IC) Surrounding the corpus cavernosum (CC) dur 55 on the middle part of the penis (P), one to the right and one to
ing the muscular phase, which is the second penis (P) erection the left, the electrode may also be placed on various regions of
phase. the penis, particularly along the dorsal nerve apart from the
The measuring method consists of continuously measur SSO.
ing, particularly when the patient is sleeping, the arterial The method for treating a patient with erectile dysfunction
inflow and venous outflow by measuring the pulse pressure 60 consists in that the patient starts the electro stimulation sys
(PP), pulse volume (PV) and intracavernous pressure (ICP). tem of the housing and adjusts the intensity of the stimulation
The measuring method consists of measuring the Young's by using either a potentiometer placed on the housing or a
modulus of the corpus cavernosum (CC) allowing the com virtual button placed on the screen of either the computer, a
pliance of said corpus cavernosum to be evaluated. PDA or a portable telephone.
The measuring method consists of measuring and quanti 65 The method for treating a patient with erectile dysfunction
fying the cavernosal venous leak from the intracavernous consists in that the electro stimulation is continued until the
pressure (ICP) curve. end of the session, as with all muscle rehabilitation, since it
 US 9, 180,284 B2
3 4
improves the performance of the ischiocavernosus muscle chambers filled with a fluid, separated by a wall pierced with
(IC) rehabilitation, as well as the vasodilation of the cavern a calibrated orifice connecting said chambers between each
osal arteries. other, said first chamber being connected to the three-way
The method for treating a patient with erectile dysfunction valve while said second chamber comprises a piston allowing
consists in that the patient verifies that his Voluntary contrac the pressure of the fluid to be varied by means of a micrometer
tions cause an elevation in intracavernous pressure (ICP), setting device.
which proves that the right muscles are contracted, since only The measuring and/or rehabilitation device comprises a
the ischiocavernosus muscles (IC) raise the intracavernous micrometer setting device comprising a spring disposed
pressure (ICP). around the operating rod of the piston in order to adjust the
The method for treating a patient with erectile dysfunction 10
tension of said spring and to maintain stable pressure in the
consists in that the patient then sees a mask of muscle con cuff while allowing high, short-duration pressure variations.
tractions appear on the screen that he is invited to follow, The measuring and/or rehabilitation device consists in that
indicating the optimum duration and height of the contraction
that must be made as well as the duration of the rest phase. the cuff is held and closed around the penis of the patient by
The method for treating a patient with erectile dysfunction 15
a non-elastic tie.
consists in that the mask of muscle contractions is adjustable The measuring and/or rehabilitation device comprises a
and established from the fatigue curve of the ischiocaverno housing containing an amplifier, an analog to digital con
SuS muscle (IC). Verter, a microprocessor and a removable memory card.
The method for treating a patient with erectile dysfunction The measuring and/or rehabilitation device comprises a
consists in that modifications in the pattern indicating the housing comprising an electro stimulation system.
modalities of the contraction to be performed will be calcu The measuring and/or rehabilitation device consists in that,
lated either in real time by the microcontroller during the as the photoplethysmograph is sensitive to pressure, the latter
session or between two sessions when this analysis will be is positioned at a certain distance from the reservoir to prevent
done by the analysis and telecontrol center (ATC). the pressure variations from said reservoir from disturbing
The method for treating a patient with premature ejacula 25 said photoplethysmograph.
tion consists of the perineal rehabilitation that is obtained by The measuring and/or rehabilitation device consists in that
means of the measuring device with electro stimulation of the the photoplethysmograph comprises a light-emitting diode
penis (P) through electrodes positioned under the sensor, and a photoelectric cell allowing a light ray to be sent in the
electro stimulation of the penis Pallowing the ischiocaverno direction of the flexible membrane and to receive the reflected
SuS muscles (IC) surrounding the corpus cavernosum (CC) to 30
ray captured by the cell, while said signal emitted by the
be strengthened and promoting the increase in arterial circu photoplethysmograph is transmitted to the housing that
lation and thus the erection necessary for rehabilitation. allows said signal to be amplified and recorded.
The method for treating a patient with premature ejacula The measuring and/or rehabilitation device comprises a
tion consists in that the patient may do this rehabilitation at sensor constituted of:
home according to the same method as that described for 35
An open or half-open ring comprising two branches in an
erectile dysfunction rehabilitation.
The method for rehabilitating a patient with premature arc of circumference interconnected by a flexible ele
ejaculation consists in that the stimulation of the vascular ment,
reflex is obtained when the patientacts by a pressure variation A strain gauge integral with the flexible element and con
on the gland by Small compressions between the thumb and 40 nected to the housing.
index finger to produce an increase in the arterial flow of the The measuring and/or rehabilitation device consists in that
cavernosal arteries such that this stimulation of the vascular the branches are flat, plate-shaped branches made in a mate
reflex combined with electro stimulation of the ischiocaver rial with high elastic deformation strength, or a material that
nosus muscles (IC) most often produces a rigid erection of the is said to be not very deformable.
penis (P) necessary for rehabilitation. 45 The measuring and/or rehabilitation device consists in that
The measuring and/or rehabilitation device comprises a the flexible element connecting the branches is constituted of
sensor that is constituted of: a thin plate of metal presenting significant elastic deformation
A cuff integral on its inner face with a reservoir filled with characteristics.
a liquid allowing the intracavernous pressure (ICP) and The measuring and/or rehabilitation device comprises a
pressure variations to be received, 50 ring comprising, on the inner face of the branches, contact
Stimulation electrodes positioned between the reservoir areas constituted of rubber dots presenting low elastic defor
and the outer wall of the penis of the patient, mation and pressing against the penis (P) of the patient so as
And connection tubing connecting the reservoir to a pho to slightly offset the inner face of said branches of the ring.
toplethysmograph and to a pressure transducer that are The measuring and/or rehabilitation device comprises a
connected to the housing. 55 ring comprising electro stimulation means that are consti
The measuring and/or rehabilitation device comprises a tuted of electrodes disposed on the rubber dots.
cuff connected through a first three-way valve to the photop The attached drawings, given by way of example, allow the
lethysmograph measuring the displacements of a flexible invention, the characteristics that the invention presents and
membrane integral with the connection tubing in order to the advantages that the invention is likely to bring to be better
measure the Volume of the penile pulse coming from the 60 understood:
cavernosal arteries. FIG. 1 is a perspective view illustrating a measuring and
The measuring and/or rehabilitation device comprises a treating device comprising a sensor made from a non-elastic
cuff connected through the second connection tubing and a cuff according to the present invention.
second three-way valve to a pressure regulator to ensure FIG. 2 is a schematic view representing a pressure regula
stable pressure inside the reservoir of the cuff. 65 tor that may be installed on the tubing for Supplying the
The measuring and/or rehabilitation device comprises a reservoir of the measuring and treating device according to
pressure regulator constituted of a cylinder comprising two the present invention.
 US 9, 180,284 B2
5 6
FIGS. 3 to 5 are views showing a measuring and treating The measuring device 1 comprises electrodes 22 that are
device comprising a sensor made from a ring in a closed positioned under reservoir 3 so as to be in contact with the
position known as "detumescence' according to the present outer face of the penis P of the patient when the cuff 12
invention. surrounds the latter. Electrodes 22 are applied to the skin of
FIG. 6 is a view illustrating the ring in an open position the penis P.
known as "erection according to the present invention. Electrodes 22 are connected to the housing 35 comprising
FIG. 7 is a diagram showing the variations in pressure an electro stimulation system allowing electrical pulses to be
measured by the measuring and treating device according to sent to said electrodes 22 in order to ensure controlled electro
the present invention. stimulation according to the measurement of IC muscle
FIG. 1 shows a measuring device 1 allowing the intracav 10
fatigue and/or the measurement of other settings. Such as the
ernous pressure and blood flow at the level of the penis P of a measurement of the ICP of the erector muscles surrounding
patient to be measured. the corpus cavernosum of the penis P.
Measuring device 1 is constituted of a sensor 2 formed It is noted that the electrical stimulation of the electrodes 22
from a cuff 12 made of a non-elastic synthetic material inte is controlled by the patient so as to be perceived without ever
gral on its inner face with a reservoir 3 in plastic filled with a 15
being painful. The patient may at any time vary the intensity
fluid such as water.
Cuff 12 comprises, at one of the ends of its inner face and that is also adjusted by the microcontroller as indicated
in the extension of reservoir 3, a first self-gripping strip 4 above.
cooperating with a second self-gripping strip 5 provided at the The measuring device 1 comprises at the level of the sec
other end and on the outer face of said cuff 12. ond three-way valve 13 a pressure regulator 23 that ensures
The first and second self-gripping strips 4, 5 cooperate with stable pressure inside the reservoir 3 of cuff 12.
each other to ensure closing without elastic deformation of FIG.2 shows the pressure regulator 23 that is constituted of
the cuff 12 around the penis P. a cylinder 24 comprising two chambers 25, 26 filled with a
Closing of the cuff 12 around the penis is completed by a fluid such as water and separated by a wall 27 pierced by a
non-elastic tie 6 integral on each of its opposed faces and at 25 calibrated orifice 28 of low diameter connecting said cham
each end of the self-gripping strips 7, 8 allowing said tie 6 to bers between each other.
be attached around the cuff 12. The first chamber 25 is connected through the second
The measuring device 1 comprises a first three-way valve 9 three-way valve 13 to the tubing of measuring device 1, while
in which the first tubing 10 is connected in a watertight the second chamber 26 comprises a piston 29 allowing stable
manner inside the reservoir 3 in a plastic material. 30 pressure to be maintained inside said chamber 26, which
The first three-way valve 9 comprises a second tubing 11 pressure may be adjusted by means of a micrometer setting
that is connected to a second three-way valve 13 allowing the device 30.
connection to a pressure regulator 23 and to a tubing 20 In fact, the micrometer setting device 30 acts on a spring 31
connected to another three-way valve 17, connected to a disposed around the operating rod of the piston 29 in order to
pressure sensor or transducer 21. 35 adjust the tension of said spring and thus the pressure exerted
The first three-way valve 9 comprises a third tubing 14 that by the piston 29 inside the second chamber 26.
is sealed by a flexible membrane 15 made, for example, of Thus, the controlled displacements of the piston 29 inside
latex. A photoplethysmograph 16 is placed near the flexible the second chamber 26 allow either the fluid contained in
membrane 15 so as to be able to measure the displacements chamber 25 to be aspirated or more fluid to be added inside
induced by the arterial pulse in the corpus cavernosum of the 40 the latter through the calibrated orifice 28 and thus a stable
penis P. pressure to be maintained inside the single reservoir 3 what
The photoplethysmograph 16 comprises a light-emitting ever the variations in the volume of the penis P.
diode and a photoelectric cell allowing a light ray to be sent in The calibrated orifice 28 allows the measuring device 1 to
the direction of the flexible membrane 15 and the reflected ray record short-duration pressure variations at the level of res
captured by the cell to be received. The signal emitted by the 45 ervoir 3 and thus pressure peaks coming from ischiocaverno
photoplethysmograph 16 is transmitted to a housing 35 that SuS muscles IC contractions of the penis P and pulse varia
allows said signal to be amplified and recorded. tions to be recorded while maintaining stable pressure in the
The housing 35 contains amplifiers, an analog to digital cuff 12 whatever the variations in volume of the penis P.
converter, a microprocessor, an electro stimulation system preventing painful tightening.
and a removable memory card. As the photoplethysmograph 50 FIGS. 3 to 6 represent a measuring device 1 comprising a
16 is sensitive to pressure, the latter is positioned at a certain sensor that is constituted of an open ring or half ring 50
distance from the reservoir 3 to prevent pressure variations comprising two branches 51, 52 in an arc of circumference
from said reservoir from disturbing said photoplethysmo interconnected at the top of the circular profile by a flexible
graph 16. element 53.
Also, the first three-way valve 9 allows, as a function of the 55 Branches 51, 52 are plate-shaped flat branches made in a
measurements and controls to be performed, the photopl material with high elastic deformation strength, or a material
ethysmograph 16 to be connected or disconnected, allowing it that is said to be not very deformable.
to be either used or not used. Ring 50 comprises on the inner face of branches 51, 52
The measuring device 1 comprises a third three-way valve contact areas pressing against the penis So as to slightly offset
17 allowing the pressure sensor 21 to be connected to measure 60 the inner face of said branches from the latter.
the pressure in reservoir 3. The signals measured by the The contact areas are made through rubber dots 54 present
pressure sensor 21 are transmitted to the housing 35 to be ing low elastic deformation in order to promote cutaneous
amplified and recorded. circulation and to prevent a tourniquet from forming during
The third three-way valve 17 allows a syringe, not illus the erection.
trated, to be positioned, ensuring tubing parts 10, 11, 14 and 65 Ring 50 comprises electro stimulation means that are con
20 and reservoir 3 of the measuring device 1 are filled without stituted of electrodes 56 disposed on the rubber dots 54 in
the presence of air. order to ensure controlled electro stimulation allowing the
 US 9, 180,284 B2
7 8
best measurement of the ischiocavernosus muscle IC Sur This significant elevation in intracavernous pressure (ICP)
rounding the corpus cavernosum of the penis P. is only possible thanks to the tunica albuginea preventing the
The flexible element 53 connecting the branches 51, 52 is corpus cavernosum (CC) from dilating.
constituted of a thin plate of metal presenting significant To obtain a rigid erection, thus having a high intracavern
elastic deformation characteristics. ous pressure (ICP) due to contraction of the ischiocavernosus
The flexible element 53 comprises on one of its faces a muscles (IC), the vascular phase must precede the muscular
strain gauge 55 that is connected by any means to housing 35 phase.
of the measuring device 1. In fact, if the vascular phase is not achieved, the tension
Branches 51, 52 of ring 50 may cross with respect to each 10
exerted on the tunica albuginea is low and consequently its
other to constitute a closed ring. In this case, it suffices to act elasticity is high. The muscle contraction is then weak or not
on the free end of branches 51, 52 to obtain a slight deforma effective.
tion of the flexible element 53 in order to be able to place the This is explained and measured by the Young's modulus of
ring 50 around the penis P of the patient. the corpus cavernosum (CC) and the tunica albuginea.
The structure and composition of the ring 50 enables it to 15 Young's modulus indicates that when a low tension is
be adapted to different volumes and circumferences of the exerted on the tunica albuginea, its elasticity is high, while
penis P without restricting the blood circulation within the with a high tension, its elasticity diminishes.
latter. If the intracavernous pressure (ICP) is low, the Young's
Thus, variations in the volume of the penis Pare obtained modulus of the tunica albuginea is low, leading to a slight
by the larger or smaller opening of the ring 50 that is measured variation in intracavernous pressure (ICP), (delta ICP),
by the deformation of the flexible plate or base plate 53 and caused by the contraction of the ischiocavernosus muscles
recorded by the gauge 55. (IC), since the pressure variation (delta ICP) is absorbed by
Also, variations in pressure are obtained by deformation of the elasticity of the tissues.
the base plate 53 according to its elasticity and are measured On the other hand, at the end of the vascular phase, if the
and recorded by the gauge 55. 25 tumescence is complete, the tension exerted on the tunica
Due to its conformation, ring 50 enables passing from a albuginea is high, its elasticity is low, the Young's modulus is
closed position known as "detumescence to an open position high, causing a pressure variation (delta ICP) that is poorly
known as "erection.” The different positions of the ring 50 absorbed by the elasticity of the tissues and thus significant
allow variations in pressure and volume of the penis P to be 30
variations in intracavernous pressure (ICP).
measured; the compliance of the latter is thus delta V/delta P. The three most frequent causes of impotence are:
Erection and Physiological Measurements (FIG. 7) Arterial causes due to reduction in inflow,
Penile erection quality is only the reflection of the intrac Leaks due to the absence of reduction in outflow, these two
avernous pressure (ICP). Detumescence or the state of rest is causes being disturbances in the arterial-venous flows
the consequence of low intracavernous pressure (ICP) on the 35 (AVF),
order of 10 to 20 mm/hg. Muscular causes due to a reduction in muscle strength of
Increasing the intracavernous pressure (ICP) leads to an the ischiocavernosus muscles (IC).
increase in the Volume of the penis and in its hardness. The measuring device 1 comprising either a sensor 2 con
Tumescence is the consequence of a mean intracavernous stituted of a cuff 12 or a sensor formed from a ring 50 allows
pressure (ICP) on the order of 100 mm/hg to 120 mm/hg. 40 the needs stated above to be met.
Rigidity is the consequence of high intracavernous pres Arterial Causes or Inflow Measurement
sure (ICP), greater than 400 mm/hg. Measuring inflow is conventionally done by the Doppler
Increasing the Volume during an elevation in intracavern effect. The Doppler effect measures the speed of blood but
ous pressure (ICP) is proportional to the elasticity of the does not measure the flow, unless the diameter of the vessels
corpus cavernosum (CC) defining the delta V/delta P compli 45 is known, which is possible but not very precise. Variations in
aCC. flow can be measured by measuring the Surface under the
During an erection, the intracavernous pressure (ICP) pro Doppler signal curve, but these are only variations.
gressively reaches the mean systolic pressure, or 100 to 120 In addition, Doppler effect measurements are not adapted
mm/hg. The maximum volume of the penis is reached when to continuous measurements since the investigatoris required
penile elasticity is blocked by the tunica albuginea, allowing 50 to be continuously present. This is due to the fact that the
the maximum volume of the penis P to be measured. This position of the Doppler probe must be maintained with a
mean systolic pressure measurement is illustrated by the base precise angle with relation to the artery, the least movement
line in FIG. 7. “losing the signal.
The tunica albuginea is a membrane with low compliance Doppler is thus poorly adapted to continuous measure
that Surrounds the corpus cavernosum (CC), preventing its 55 ments, especially during sleep.
dilation, which enables the pressure to be elevated. This is the reason for which the measuring device 1 accord
The vascular phase is the first phase of erection, or tumes ing to the present invention ensures that inflow is continu
cence, the consequence of the increase in the arterial-venous ously measured, particularly during sleep, by measuring the
flows (AVF), that is the inflow (arterial) into the corpus cav pulse pressure (PP) and pulse volume (PV).
ernosum (CC) associated with a reduction in outflow 60 The measuring device 1 allows arterial-venous flows
(venous). (AVF), that is, the flow of the cavernosal arteries, or inflow, to
The second phase, known as the muscular phase, only be measured. This method is based on measuring the pulse
becomes effective once the first vascular phase is obtained. pressure (PP). In fact, during nocturnal or diurnal recordings,
Contraction of the ischiocavernosus muscles (IC) Surround we observe, after injection of a vasodilator, that variations in
ing the corpus cavernosum (CC) increases the intracavernous 65 pressure generated by the pulse are visible. These pressure
pressure (ICP) from 100 m/hg to 400, or 600 mm/hg or more, variations correlate with the blood flow under certain condi
which constitutes penile rigidity. tions.
 US 9, 180,284 B2
9 10
Measuring device 1 allows the arterial-venous flows Thus, this is a leak caused by a muscle contraction that
(AVF), that is, the inflow, to be continuously measured forces out a quantifiable volume of blood. In fact, we can
according to two different methods: count the number of heartbeats necessary for its filling, and
Either by pulse volume (PV), which requires two different knowing the pulse Volume we can deduce the leak volume
sensors, one pressure sensor to measure the intracavern- 5 during a contraction.
ous pressure (ICP) and the other a photoplethysmograph For a normal patient, the corpus cavernosum (CC) compli
(PPL) to measure the flow, ance is high and the intracavernous pressure (ICP) suffi
Or by pulse pressure (PP) with a single sensor that simul ciently compresses the venous network to allow the arterial
taneously measures the intracavernous pressure (ICP) 10 venous flows (AVF), and more particularly the outflows, to
and pressure variations in the pulse pressure (PP). remain equal to the inflows, this is the physiological leak.
Leaks Due to the Absence of Reduced Outflow During a contraction of the ischiocavernosus muscles (IC),
Venous leaks, or cavernosal leaks, or cavernosal venous the sudden elevation in intracavernous pressure (ICP) is due
leaks are the main causes of the absence of reduced outflow. to an extrinsic compression of the tunica albuginea by the
This is due to a reduction in elasticity or compliance of the 15 ischiocavernosus muscles (IC). This pressure is transmitted
corpus cavernosum (CC) that restricts its dilation (and thus to the inner face of the tunica albuginea and then to the corpus
erection), but especially hinders the reduction in arterial cavernosum (CC), which causes a Sudden elevation in the
venous flows (AVF) and more particularly the outflow. intracavernous pressure (ICP) and a strong compression of
In fact, the venous network of the corpus cavernosum (CC), the venous network.
which enables the outflow, is at the periphery of the corpus 20 On the other hand, if the compliance is low, the transmis
cavernosum (CC) under the tunica albuginea, and is thus sion of pressures is not sufficient to obtain a complete com
situated between the corpus cavernosum (CC) and the tunica pression of the veins, which forces a volume of blood outside
albuginea. of the corpus cavernosum (CC).
During dilation of the corpus cavernosum (CC), whose The leak is measured from the surface of the triangle
compliance is high, the venous network is compressed 25 observed just after a Voluntary muscle contraction.
between the corpus cavernosum (CC) and the tunica albug For a pathological patient, especially if a leak is suspected,
inea, whose compliance is low. measuring the Young's modulus of the corpus cavernosum
If, for pathological reasons, the compliance of the corpus (CC) becomes fundamental since it enables the corpus cav
cavernosum (CC) diminishes, venous compression cannot ernosum (CC) compliance to be evaluated, and thus the cause
take place. The arterial-venous flows (AVF), and more par- 30 of the leak to be confirmed.
ticularly the outflow, are not reduced; we then speak of a Several techniques exist to measure the Young's modulus
venous leak that is in fact a cavernosal venous leak not con
nected to a venous pathology but rather to a cavernosal of as
the corpus cavernosum (CC). Of course this measurement,
well as the evaluation of the corpus cavernosum (CC)
pathology.
In this case, even if the outflow is sufficient, the intracav- 35 compliance, may be carried out with the measuring and con
ernous pressure (ICP) cannot rise if the leak is significant. In trol device according to the present invention.
case of a slight leak, the inflow may compensate for this loss Muscular Causes Due to a Reduction in Muscle Strength of
by increasing the flow. the Ischiocavernosus Muscles (IC).
The measuring device 1 allows the leak from the intracav Muscle contraction is visible on the curve illustrated in
ernous pressure (ICP) curve to be measured. 40 FIG. 7; this is a muscle contraction that perfectly correlates
The curve illustrated in FIG. 7 represents the intracavern with the electromyographic EMG activity of the ischiocaver
ous pressure (ICP), wherein the baseline indicates the level of nosus muscles (IC).
the intracavernous pressure (ICP) outside of a contraction of There is even a causal link between the peaks recorded and
the ischiocavernosus muscles (IC). As the Sudden elevation in the contraction of the ischiocavernosus muscles (IC). Con
pressure corresponds to a contraction of the ischiocavernosus 45 traction of the ischiocavernosus muscles (IC) constitutes
muscles (IC), it perfectly correlates with the electromyo penile rigidity.
graphic activity of the ischiocavernosus muscles (IC). The measuring and control device 1 according to the
During sleep, these contractions are involuntary and during present invention enables the following measurements to be
a rehabilitation session they are Voluntary, but the appearance taken, either at night or during an artificial erection:
of the curve is identical. 50 Pmax: Maximum contraction,
The measuring device 1 enables a drop in intracavernous delta P: The pressure gradient recorded above the base line,
pressure (ICP) below the base line just after a voluntary The mean delta during a session or a night.
contraction (muscle contraction), then an increase in several The surface under the curve of each contraction objectify
seconds to regain the level of pressure obtained just before the ing the work provided by the muscle and the average of
contraction, to be demonstrated. 55 these surfaces,
In fact, when the intracavernous pressure (ICP) is stable, The number of peaks,
the value of the intracavernous pressure (ICP) is none other The width of each peak measured at its base and their
than the mean systolic pressure; the arterial-venous flows average,
(AVF) and more particularly the inflow are then equal to the Measurement of the leak,
outflows since the intracavernous pressure (ICP) is stable, 60 Inflows and outflows,
allowing the outflow to be measured. Arterial-venous flows (AVF).
The sudden drop in intracavernous pressure (ICP) is caused Nocturnal Recording Procedure
by the muscle contraction. In fact, outside of these contrac The measuring device 1 constituted of the sensor 2, 50
tions, a Sudden drop in the intracavernous pressure (ICP) is according to the present invention allows the rehabilitation of
never observed. This pressure drop is due to a slight reduction 65 patients with erectile dysfunction and premature ejaculation
in the Volume of blood contained in the corpus cavernosum to be monitored, these patients having been diagnosed thanks
(CC). to the measurement of their nocturnal erections.
 US 9, 180,284 B2
11 12
Measurement of nocturnal erections is essential for deter Treatment is obtained by rehabilitation that is specially
mining the type of impotence, that is, psychogenic impotence indicated for patients presenting a muscular pathology having
Versus organic impotence. a normal vascular phase, but also for those having a mixed
The measuring device 1 utilized for nocturnal measure vascular pathology of arterial or venous and muscular origin.
ments is practically the same as that described previously, it This rehabilitation may be carried out either by means of
differs in that it is not connected to a computer screen 18, data the cuff 12, or by means of the open or half open ring 50
are stored in a removable memory and there is no electro equipped with electrodes 56 described previously. By way of
stimulation system. a non-limiting example, only rehabilitation with cuff 12 was
The analysis software is also a little different, since it 10
described, knowing that the rehabilitation will be substan
particularly calculates the duration of erections and the num tially identical with ring 50.
ber of erections and establishes Zooms on each erection. The patient is placed on an examination bed or on his bed,
The recording is done at home, without sleep recording, but electrodes 22 connected to housing 35 are placed on the
may also take place in a sleep laboratory. middle part of penis P. one at the right and the other at the left;
If the recording is done at home, the housing 35 is entrusted 15 they may also be placed on various regions of the penis,
to the patient, who comes to pick it up at the physician’s particularly along the dorsal nerve apart from the cuff 12.
office. Reservoir 3 of cuff 12 was filled beforehand by the physi
Prior to this, the physician will have programmed the hous cian with 2 CC of water through a syringe, while pressure
ing 35 in order to record the characteristics of the patient sensor 21 is connected to housing 35. As the patient does not
(date, last name, first name, age, tobacco use, pathologies are have to handle the syringe, it will remain at the office of the
detailed, glycemia, cholesterol, medications, and all other physician.
information likely to intervene in his erectile function). Housing 35 contains an amplifier, an analog to digital
The physician, after having recorded the data of the patient, converter, a microprocessor and an electro stimulation sys
Verifies the battery charge, calibration and proper functioning tem.
of the recording. He disconnects the housing 35 from his 25 The housing 35 is connected by a USB cable or by a
computer and entrusts it to the patient, accompanied by a Bluetooth system or by another system to a computer 18. The
memo explaining the connection. device is turned on and the physician proceeds with resetting
At bedtime, the patient places, for example, the cuff 12 of the pressure sensor 21, either automatically after one minute
the sensor 2 integral with reservoir 3 on his penis P. Reservoir ofoperation, or by using a virtual button situated on the screen
3 is connected by tubing parts 10, 11 and 20 and three-way 30 of either the computer 18, or a PDA, or a portable telephone
valves 9, 13 and 17 to the pressure sensor 21 that is connected allowing the housing 35 to be controlled (off on, reset, electro
to housing 35. Tubing parts 10, 11 and 20 are provided in a stimulation).
length of at least one meter allowing the patient to place the The electro stimulation system of the housing 35 is started,
assembly nearby on his bedside table or on the floor. and the patient adjusts the intensity of the stimulation either
Once lying down, the patient starts the measuring device 1 35 by using a potentiometer placed on the housing 35 or by using
by using the on-off button provided on housing 35, a blinking a virtual button situated on the screen of either the computer
red LED indicating that the recording has started. An auto 18, or a PDA, or a portable telephone.
matic Zero reset of the pressure sensor 21 is performed by the An intracavernous injection of a vasodilator is then carried
Software after several minutes of recording. out in all patients for whom the erection is insufficient fol
After waking up, the patient verifies that the LED is still lit, 40 lowing stimulation of the vascular reflex to cause an erection.
attesting to the fact that the recording was not interrupted This injection also participates in the improvement of the
during the night. The patient turns the housing 35 off. arterial component.
The patient starts the same operations described above over The electro stimulation is continued until the end of the
again on the following nights. session, as with all muscle rehabilitation, since it improves
After three consecutive nights, the patient brings the mea 45 the rehabilitation performance of the ischiocavernosus
Suring device 1 back to the physician, who transfers the data muscles (IC) as well as the vasodilation of the cavernosal
contained in a removable memory disposed in housing 35 to arteries.
his computer. The patient must then verify that the voluntary contractions
The data are partially or completely analyzed by the soft cause an elevation in intracavernous pressure (ICP), which
ware and/or then sent, via the Internet, in the database of the 50 proves that the right muscles are contracted, since only the
analysis and telecontrol center (ATC). A hard copy of the ischiocavernosus muscles (IC) raise the intracavernous pres
curves, Zooms and calculations of each night will be printed, sure (ICP).
and the complete analysis will be possibly sent by the analysis The patient then sees a mask of muscle contractions appear
and telecontrol center (ATC). on the screen, that he is invited to follow, which indicates the
This nocturnal recording procedure may be carried out 55 optimal duration and height of the contraction that must be
with the measuring device 1 constituted of the open or half made as well as the duration of the rest phase.
open ring 50. This adjustable mask is established from the fatigue curve
Erectile Dysfunction Treatment Procedure of the ischiocavernosus muscles (IC). It enables the rehabili
The measuring device 1 constituted of the sensor 2.50 tation to be optimized. In fact, insufficient work will be syn
according to the present invention allows patients with erec 60 onymous with the absence of improvement but, conversely,
tile dysfunctions to be treated. This treatment may be carried an overly intense rehabilitation will exhaust the ischiocaver
out either at the attending physicians office or at the patients nosus muscles (IC). Thus, an optimal intensity exists, calcu
home. lated as a function of the fatigue curve.
When the diagnosis of organic impotence is established The fatigue of the ischiocavernosus muscle (IC) is calcu
during the night by the measuring device 1, the latter also 65 lated by measuring the angle C. formed on the curve. For a
enables treatment thanks to several modifications in the soft given peak width, the Smaller the angle C, the greater the
Wa. fatigue (FIG. 7).
 US 9, 180,284 B2
13 14
Modifications in the pattern indicating the modalities of the The invention claimed is:
contraction to be made will be calculated either in real time or 1. A method for measuring the strength of the ischiocav
during the session or between two sessions when this analysis ernous muscles of a patient with either erectile dysfunction or
will be carried out by the analysis and telecontrol center premature ejaculation or both, the method being performed
(ATC). 5 during an erection of the penis and comprising the following
Procedure for Treating Premature Ejaculation steps:
The measuring device 1 constituted of the sensor 2, 50 (a) providing, to the patient, a measuring and/or rehabili
according to the present invention allows patients with pre tation device configured to determine the strength of the
mature ejaculation problems to be treated. 10
ischiocavernous muscles of the penis, the device com
Premature ejaculation (PE) affects 30% of the male popu prising at least one sensor,
lation. Currently, the most effective treatment consists of (b) placing the sensor around an outer Surface of the penis
using certain antidepressantagents that have the advantage of of the patient;
being effective from the start of treatment but the disadvan (c) via the at least one sensor, measuring the variation of
tage of not treating premature ejaculation (PE). 15 intracavernous pressure of the penis;
In fact, upon Suspension of the drug treatment and in the (d) externally stimulating the ischiocavernous muscles of
large majority of cases, the symptom will reappear. the penis using a pair of electrodes; and
The second effective treatment utilizes a local anesthetic (e) determining whether the stimulating causes an eleva
that reduces the sensitivity of the gland, its efficacy is real but tion in intracavernous pressure,
it sometimes reduces the pleasure of the two partners. As with wherein a positive detection of said elevation in intracav
chemical treatment, the symptom will reappear upon Suspen ernous pressure indicates that ischiocavernous muscles
sion of the treatment. were contracted during the stimulation.
The premature ejaculation treatment that is the object of 2. The measuring method according to claim 1, further
the invention is obtained by perineal rehabilitation by means comprising:
of the measuring device 1 with electro stimulation of the penis 25 measuring a Young's modulus of a corpus cavernosum of
P through electrodes 22 positioned under reservoir 3 integral the penis to evaluate a compliance of said corpus caver
OSU.
with cuff 12 or electrodes 56 positioned inside ring 50.
This electro stimulation of the penis Pallows the ischio 3. A method for treating and rehabilitating the ischiocav
cavernosus muscles (IC) surrounding the corpus cavernosum ernous muscles, comprising:
(CC) to be strengthened and the increase in arterial circula 30 measuring a strength of the ischiocavernous muscles, said
tion, and thus the erection necessary for rehabilitation, to be measuring comprising the Sub-steps of
promoted. (a) providing, to the patient, a measuring and/or rehabili
Rehabilitation may, for example, be carried out at the home tation device configured to determine the strength of the
of the patient who has a housing 35 that may be connected via ischiocavernous muscles of the penis, the device com
35 prising at least one sensor,
Bluetooth to his computer or to a PDA or to his portable (b) placing the sensor around the penis of the patient,
telephone, as with the evaluation of erectile dysfunction, or (c) via the at least one sensor, measuring the variation of
through a screen integral with housing 35. intracavernous pressure of the penis,
The session is designed in the same manner; the only thing (d) externally stimulating the ischiocavernous muscles of
that is different is the fashion in which the erection necessary 40 the penis using a pair of electrodes, and
for strengthening the ischiocavernosus muscles (IC) is pro (e) determining whether the stimulation causes an eleva
duced. tion in intracavernous pressure;
The patient is invited to place the cuff 12 equipped with Voluntarily, by the patient, contracting the ischiocavernous
electrodes 22 on his penis P so that the reservoir 3 is in contact muscles; and
with the latter or the open ring 50 comprising electrodes 56. 45 determining whether the Voluntary contraction causes an
The patient turns housing 35 on and ensures that the connec elevation in intracavernous pressure.
tion operates by Verifying that a pressure variation (by press 4. The method of treating and rehabilitating according to
ing on the cuff) results in a pressure elevation on the screen of claim 3, further comprising:
the computer. determining i) a fatigue of the ischiocavernous muscles of
Stimulation of the vascular reflex is obtained by a pressure 50 the patient in order to adjust an intensity and duration of
variation on the gland by Small compressions between the ischiocavernous muscle contractions to be produced,
thumb and index finger to produce an increase in the arterial and ii) the duration of a rest period between two pro
flow of the cavernosal arteries. This stimulation of the vascu duced contractions, as a function of the said fatigue of
lar reflex combined with electro stimulation of the ischiocav the ischiocavernous muscles of the patient, a state of
ernosus muscles (IC) most often produces a rigid erection of 55 fatigue being determined by measuring an angle C.
the penis (P). formed on a curve representing the intracavernous pres
This stimulation most often causes an erection in patients Sure during Voluntary contractions of the ischiocavern
with premature ejaculation without any stimulation of the ous muscles.
ejaculatory reflex. 5. The method of treating and rehabilitating according to
When stimulation of the vascular reflex will not be suffi 60 claim 3, further comprising:
cient for initiating the erection, the use of a vasodilator prod displaying a mask of the ischiocavernous muscles contrac
uct by oral route or injection will be instituted. tion to the patient in order to indicate to the patient an
In addition, it must be understood that the previous descrip optimum duration and height of a contraction that must
tion was only given by way of example and that it in no way be made, as well as the duration of the rest period
limits the field of the invention from which one will not depart 65 between two contractions.
by replacing the details of embodiment described by any 6. The method of treating and rehabilitating according to
other equivalents. claim 5, wherein the mask of the ischiocavernous muscles
 US 9, 180,284 B2
15 16
contraction is adjustable and established from the fatigue 11. The method of treating and rehabilitating according to
state of the ischiocavernous muscles. claim 8, further comprising:
7. The method of treating and rehabilitating according to adjusting an intensity of the electro-stimulation, either by
claim 3, further comprising: using a potentiometer placed on the housing, or by using
calculating patterns for indicating to the patient the inten a virtual button situated on a screen of either the com
puter or a PDA or a portable telephone.
sity, duration and ischiocavernous muscles contraction 12. The method of treating and rehabilitating according to
to be produced and the duration of the rest period claim 8, wherein the sensor of the measuring and/or rehabili
between two contractions, said calculating step being tation device is constituted of a cuff, an inner face of the cuff
performed in either real time during a session or between 10
including a reservoir filled with a liquid configured to respond
two sessions by way of an analysis and telecontrol cen to the intracavernous pressure and pressure variations.
ter. 13. The method of treating and rehabilitating according to
8. The method of treating and rehabilitating according to claim 8, wherein the sensor of the measuring and/or rehabili
claim 3, wherein the measuring and/or rehabilitation device tation device is constituted of an open or half-open ring,
comprises the pair of electrodes, the electrodes configured to 15 comprising two branches in anarc of circumference intercon
electro-stimulate the ischiocavernous muscles, and the elec nected by a flexible element.
trodes configured to be placed to the skin of the penis wherein 14. The method of treating and rehabilitating according to
the ischiocavernous muscles are stimulated by said elec claim 3, wherein a stimulation of the vascular reflex is
trodes. obtained by the pressure variation on the penis by small
9. The method of treating and rehabilitating according to compressions between the thumb and index finger to produce
claim 8, wherein the electrodes are placed on the middle part an increase in arterial flow of cavernosal arteries of the penis,
of the penis of the patient. said stimulation of the vascular reflex, combined with electro
10. The method of treating and rehabilitating according to stimulation of the ischiocavernous muscles, intended to pro
claim 8, wherein the electrodes are configured to electro duce a rigid erection of the penis as necessary for perineal
rehabilitation.
stimulate indirectly the ischiocavernous muscles via the dor
sal nerve.