Infusion erectile system

The infusion erectile system prosthesis includes a dispensing device implanted in a scrotal sac or subcutaneously in an area adjacent the scrotal sac. The dispensing device includes a reservoir for storing erection stimulating material and a pumping arrangement for actuating movement of the erection stimulating material from the reservoir through a flow tube that joins the penis. The flow tube penetrates a peripheral portion of the penis and communicates with the corpus cavernosum. Infusion of the erection stimulating material into the corpus cavernosum causes an erection to occur. The pump which actuates movement of the erection stimulating material is actuatable manually or electrically.

BACKGROUND OF THE INVENTION 
This invention relates to penile erection systems for individuals with 
erectile dysfunction and more particularly to a novel prosthesis and 
method for stimulating an erection. 
Erectile dysfunction is a well known but unfortunately common dilemma often 
due to organic problems that deleteriously affect the processes which 
cause an erection. 
Attempts to overcome this disability have led to the development of 
prosthetic devices that are implanted in the penis to mimic an erectile 
condition. One known prosthetic device such as shown in U.S. Pat. No. 
3,832,996, comprises an elongated rigid or semi-rigid plastic material 
that permanently supports the penis in an erectile condition. This device, 
because it extends substantially the entire length of the penis can cause 
discomfort because it does not permit the penis to assume a flaccid 
condition. 
Another known prosthetic device, such as shown in U.S. Pat. No. 4,267,829 
includes a segmented prosthesis having generally rigid end sections joined 
by an intermediate expandable fluid receiving section. The intermediate 
section, during nonexpansion, is in a normally flaccid condition and thus 
allows the penis to assume a partially flaccid condition. When a 
predetermined amount of fluid is received in the intermediate section it 
expands to form an erectile continuation of the generally rigid end 
sections thereby establishing an overall erectile condition of the penis. 
This arrangement, can also be discomforting, since substantially the full 
extent of the penile body incorporates the implant. 
Other known erectile devices such as shown in U.S. Pat. Nos. 4,407,278, 
4,224,934, 4,009,711, require implantation in the penis of a prosthetic 
device that is either inflatable, expandable or includes one or more rigid 
elements. In accordance with these arrangements an erection is 
accomplished by expanding the entire prosthetic device or a portion 
thereof in cooperation with other rigid or semi-rigid inclusions. 
The permanent presence of an elongated prosthesis in the penis can be 
psychologically as well as physically discomforting and the prospect of 
such discomfort may discourage some individuals with erectile dysfunction 
from utilizing prosthetic surgery. 
It is thus desirable to provide an erectile system and method which 
stimulates an actual erection of the penis without the need for prosthetic 
devices which mimic an erection. It is also desirable that such system and 
method during periods of nonuse permit the entire penis to remain in a 
normal flaccid condition. 
OBJECTS AND SUMMARY OF THE INVENTION 
Among the several objects of the invention may be noted the provision of a 
novel erectile system, a novel erectile system which is based on the 
infusion of a predetermined amount of an erection stimulating material in 
the penis, a novel erectile system which permits the subject to store 
erection stimulating material until needed and to infuse a predetermined 
amount of such material in the penis when desired, a novel erectile system 
which can be implanted in the subject to cause an erection by infusion of 
erection stimulating material into the penis, a novel infusion erectile 
system which is actuatable by the subject to infuse predetermined amounts 
of erection stimulating material into the penis, and a novel method for 
producing an erection in individuals with erectile dysfunction. 
Other objects and features of the invention will be in part apparent and in 
part pointed out hereinafter. 
In accordance with the present invention the infusion erectile system 
includes a device for dispensing erection stimulating material in the 
penis, which device can be implanted in the scrotal sac or subcutaneously 
in an adjacent area. 
The dispensing device infuses a predetermined amount of the erection 
stimulating material into the penis through a flow means that is joined to 
a peripheral portion of the penis. An end portion of the flow means 
penetrates the penis for communication with the corpus cavernosum. 
The erection stimulating material is infused in the penis from a reservoir 
of the dispenser by means of a pumping arrangement. The dispenser also 
includes a metering arrangement for metering a predetermined amount of the 
erection stimulating material that can be pumped into the flow means for 
infusion into the penis. 
The dispenser can be actuated manually or electrically, as by a battery 
source, and preferably includes a control device that establishes a 
predetermined minimum time delay before the pump can pump a predetermined 
required dosage of erection stimulating material. 
The erection stimulating material which has been found to provide good 
results is papaverine, which produces a quality erection in individuals 
afflicted with various forms of erectile dysfunction. The present 
invention thus provides a desirable alternative to prosthetic devices 
which mimic erection. 
The invention accordingly comprises the constructions and method 
hereinafter described, the scope of the invention being indicated in the 
claims.

Corresponding reference characters indicate corresponding parts throughout 
the several views of the drawings. 
DETAILED DESCRIPTION OF THE INVENTION 
An infusion erectile system prosthesis incorporating one embodiment of the 
invention is generally indicated by the reference number 10 in FIG. 1. 
The prosthesis 10 includes a generally cylindrical-shaped dispenser 12 with 
a reservoir section 14 containing an erection stimulating material 16. 
Preferably the erection stimulating material 16 is a mixture of papaverine 
and phentolamine in weight ratios of about 30:1 respectively as disclosed 
in Intracavernous Drug-Induced Erections In The Management of Male 
Erectile Dysfunction: Experience With 100 Patients by Abraham A. Sidi et 
al, The Journal of Urology, Vol. 135, April 1986. Accordingly, 
approximately one bolus of the foregoing papaverine and phentolamine 
mixture, when infused in the corpus cavernosa of the penis, should 
stimulate an erectile condition of the penis. 
The dispenser 12 has a peripheral shell or housing 18 preferably formed of 
silicone rubber. A septum 20 is provided at the reservoir section 14 to 
permit refilling of the reservoir 14 with the erection stimulating 
material 16. 
The septum 20, shown in simplified schematic form, includes a needle 
penetrable sealing disk 22 joined in leak tight fashion to a cup-shaped 
support member 24. The support member 24 is likewise held in leak tight 
fashion by an inwardly-stepped, ring-shaped section 26 formed integrally 
with the shell 18. 
The dispenser 12 further includes a pump section 30, preferably formed of 
silicone rubber and joined to the interior of the shell 18 over the 
reservoir section 14. The pump section 30 includes a blind pump channel 32 
which slidably accommodates a reciprocable plunger 34 having a stem 
portion 36 with an O-ring seal 38. 
A plunger head 40 is formed at one end of the stem portion 36 and is 
disposed in a depressible chamber section 42 of the shell 18. A biasing 
member, such as a spring 44, biases the plunger 34 into a normally 
retracted position with respect to the pump channel 32, as shown in FIG. 
1, wherein the plunger head 40 engages an end wall 46 of the depressible 
section 42. 
The pump section 30 also includes a depending fluid draw section 50 having 
an extension tube 52 extending into the reservoir 14. The fluid draw 
section 50 is formed with a draw channel 54 that communicates with the 
pump channel 32. The draw channel 54 has a valve seat 56 with a ball valve 
58. The ball valve 58 closes off the extension tube 52 under the influence 
of a biasing spring 60 confined in the draw channel by an annular 
formation 62. 
A receiving section 64, formed opposite the fluid draw section 50, includes 
a receiving channel 66 that communicates with the pump channel 32. The 
receiving channel 66 includes a valve seat 68 with a ball valve 70. The 
ball valve 70 closes communication between the receiving channel 66 and 
the pump channel 32 under the influence of a biasing spring 72. The spring 
72 is confined in the receiving channel 66 by a reduced neck portion 74 of 
the receiving section 64. A tube holder 76 extends from the reduced neck 
portion 74 for engagement with one end of a flow tube 78. 
The flow tube 78, which is preferably formed of silicone rubber is joined 
at an opposite end 80 to an outlet fitting 82 having dispersion openings 
such as 84 and 86 (FIG. 3). A suturing disk 88, preferably formed of 
Dacron or other ingrowth material, is provided between the tube end 80 
(FIG. 3) and a flange 90 formed on the outlet fitting 82. 
In using the infusion erectile system prosthesis 10, the dispenser 12 is 
implanted in the scrotal sac (not shown) in any suitable known manner, or 
in an adjacent area. The implantation is made such that the flow tube 78 
is joined to the penis, schematically shown at 92, by suturing the disk 88 
to the penis. The suture is accomplished after the outlet fitting 82 has 
been located in the corpus cavernosa of the penis in any suitable known 
manner. 
When it is desired to stimulate an erection of the penis 92, the user 
strokes the chamber section 42 of the dispenser 12 to depress the chamber 
section 42. The chamber 42, since it forms a projection from the generally 
cylindrical shape of the dispenser 12, is easily detectible by the user. 
Stroking of the chamber section 42 will move the stem portion 36 of the 
plunger 34 toward the draw channel 54 and the receiving channel 66, as 
shown by a comparison of FIGS. 1 and 2. 
With the plunger 34 thus protracted in the pump channel 32, any erection 
stimulating material 16 in the pump channel will be forced into the 
receiving channel 66 past the ball valve 70. Protracted movement of the 
plunger 34 will also maintain the ball valve 58 against the valve seat 56 
in the draw channel 54 thereby preventing flow of erection stimulating 
material 16 from the reservoir 18 into the draw channel 54. 
The erection stimulating material 16 that has been forced into the 
receiving channel 66 flows into the flow tube 78 toward the outlet fitting 
82 and through the dispersion openings 84 and 86 into the corpus 
cavernosum of the penis. 
The amount of erection stimulating material 16 which flows through the flow 
tube 78 can be predetermined and is preferably one bolus. 
The predetermined amount of erection stimulating fluid is determined by a 
protraction limit position of the plunger 34 which is defined by 
engagement of the plunger head 40 with the free end of the pump channel 32 
as shown in FIG. 2. After the plunger 34 has reached its protraction limit 
position, the biasing spring 44 in the pump channel 32 will urge the 
plunger 34 to a retraction limit position defined by engagement of the 
plunger 34 with the end wall 46 of the depressible section 42 as shown in 
FIG. 1. The volume displaced by movement of the plunger stem portion 36 
between the protraction limit position and the retraction limit position 
establishes the predetermined amount of erection stimulating fluid that 
flows into the draw channel 54 and the flow tube 78. 
Retraction of the plunger 34 by the biasing spring 44 causes a suction in 
the pump channel 32 that unseats the ball valve 58 from the valve seat 56 
allowing erection stimulating fluid 16 from the reservoir 18 to flow 
through the extension tube 52, into the draw channel 54 and the pump 
channel 32. 
The suction attributable to retraction of the plunger 34 also attracts the 
ball valve 70 against the valve seat 68 in the receiving channel 66, which 
prevents movement of erection stimulating material into the receiving 
channel 66 during retraction of the plunger 34. 
Thus the arrangement of the ball valves 58 and 70 and the establishment of 
protraction and retraction limit positions by the free end of the pump 
channel 32 and the end wall 46 constitute a metering arrangement for 
metering a predetermined amount of erection stimulating material 16 that 
can flow through the flow tube 78 during stroking of the plunger 34. 
If desired, the stroking of the plunger 34 can be accomplished 
electrically. Accordingly, a solenoid 94 is provided in the pump section 
30 with lead wires 96 and 98 extending out of the shell 18 for connection 
to a battery 100 and a switch 102. Preferably the battery 100 and the 
switch 102 are implanted in the scrotal area. The switch 102 can then be 
actuated through the scrotal skin. 
Also, if desired, the plunger 34 can be equipped with a delay means, such 
as a calibrated orifice 104 which limits the rate of fluid flow from the 
reservoir 14 into the pump channel 32 to a predetermined amount. Thus a 
minimum predetermined time must elapse before an effective amount of 
erection stimulating material 16 flows into the pump channel 32. The 
purpose of establishing a predetermined minimum time delay before a 
required predetermined amount of erection stimulating material 16 is 
transferred to the pump channel 32 is to maintain a recommended time delay 
period between erection stimulating cycles in accordance with the 
recommendations of a physician. 
A filter 106 can be provided between the orifice 104 and the extension tube 
52 to filter out any particulate material that might reside in the 
reservoir 14. 
Since each actuation of the plunger 34 infuses a predetermined amount of 
erection stimulating material 16 into the penis, it is a relatively simple 
matter to keep track of the amount of erection stimulating material 16 
that has been depleted from the reservoir 14. Consequently, no guesswork 
is needed to ascertain when the reservoir 14 should be refilled. Refilling 
is accomplished by penetrating the sealing disk 22 of the septum 20 with a 
hypodermic needle (not shown) to transfer erection stimulating material 
into the reservoir 14. 
Some advantages of the present invention evident from the foregoing 
description include a novel infusion erectile system prosthesis which 
permits the user to synthesize an erection by chemical stimulation. The 
resulting erection is of substantially the same quality as a normal 
erection, since it occurs from the same processes that produce a normal 
erection. 
The use of an erection stimulating material thus enables the subject to 
achieve an erection without the rigid, semi-rigid and expandible 
prostheses that have long been used to mimic an erection. The omission of 
expandible devices and rigid implants enable the user to experience a 
normal flaccid comfortable condition of the penis when there is no need 
for the erectile condition. 
In view of the above, it will be seen that the several objects of the 
invention are achieved and other advantageous results attained. 
As various changes can be made in the above constructions and method 
without departing from the scope of the invention, it is intended that all 
matter contained in the above description or shown in the accompanying 
drawings shall be interpreted as illustrative and not in a limiting sense.