Remote controllable penile prosthetic system

An implantable penile prosthesis system which includes a fully implantable and elongatable prosthesis that is operated by remote control.

BACKGROUND OF THE INVENTION 
The present invention relates generally to penile erection systems for 
overcoming erectile dysfunctions. More particularly, it relates to penile 
erection systems which are remotely controlled and elongatable, as well as 
a method of operating the same. 
A wide variety of approaches have been proposed for overcoming erectile 
dysfunctions to thereby alleviate the trauma associated therewith. One 
practice generally accepted is to apply a vasodilator type drug directly 
to the penis for selectively effecting erections. Significant difficulties 
tend to arise, however, with the application of these drugs since dosages 
are usually self-administered by injection. Such injections have a 
tendency to be both frightening and painful to some patients. In addition, 
repeated injections may result in hematoma, infection, and eventually 
penile fibrosis. Consequently, there are significant drawbacks. 
Another common approach for overcoming dysfunctions includes utilization of 
implantable protheses. A number of different types of protheses have been 
proposed. Penile erections are achieved upon selective introduction of 
fluid to an extensible chamber of the prosthesis implant that is located 
within a portion of a penis. Essentially, the fluid is transferred from a 
suitable reservoir, which is either integral with the implant or separate 
therefrom, through a valve system and finally into an extendable distal 
end chamber of the prothesis which expands and causes penile erection. 
Return of the penis to a flaccid condition occurs when the fluid is 
withdrawn from this distal end chamber and returns to the reservoir. 
A variety of mechanisms exist for operating implant systems. The 
overwhelming majority of them tend to require distinct manual 
manipulations of a separate reservoir in the form of a bulb or some other 
comparable component for forcing the fluid into the distendable chamber 
for effecting an erection. Subsequently, compression of the filled chamber 
manually effects fluid return to the reservoir to thereby bring about a 
flaccid penile condition. There are, however, disadvantages associated 
with such mechanisms, not the least of which includes significant 
inconvenience, such as in obtaining manual proficiency required in 
manually pumping the fluid to effect either erect or flaccid penile 
conditions. 
Still another known approach is described in U.S. Pat. No. 4,941,461 issued 
to Fischell. This patent describes use of a remote control device for 
remotely controlling erection of a penile prosthetic implant by generating 
a rapidly alternating magnetic field for inducing operation of a solenoid 
type pump, which pump is self-contained in the prothesis. In fact, the 
pump acts to selectively pump fluid for effecting both the erect and 
flaccid conditions. However, this remote controlled type of prosthesis has 
several significant drawbacks associated with its use including a 
shortcoming that a relatively complicated solenoid pump is used which in 
operation makes a distracting and potentially annoying humming noise. 
Accordingly, there exists a continuing desire for improving upon known 
penile implant systems by providing not only simple, reliable, safe, and 
easy to operate systems, but ones which can be expeditiously controlled 
remotely, as well as elongate and contract reliably and automatically. 
SUMMARY OF THE INVENTION 
In accordance with the present invention there is provided an improved 
unitary penile prosthetic system which is fully implantable and controlled 
remotely, as well as a method of operating the same. 
Included in this system is an implantable penile prosthesis and a remote 
controlled device. The prosthesis includes a first fluid chamber assembly 
operable in response to the flow of pressurizing fluid housed within the 
prothesis to cause erection and elongation of the penis, as well as, 
operable in response to forced evacuation of fluid therefrom to effect a 
flaccid penile condition. A second fluid chamber assembly is provided 
which is operable for selectively storing fluid from the first chamber 
assembly when the penis is in the flaccid state and for allowing fluid 
flow to the first chamber assembly for effecting erection. Included in the 
prosthesis is a fluid transfer assembly that is coupled to and between, as 
well as cooperates with the first and second chamber assemblies for 
selectively transferring the fluid therebetween in response to remote 
control operation. In this regard, the fluid transferring assembly 
includes an energizable assembly and a valve assembly adapted to cooperate 
with the energizable assembly for selectively transferring fluid between 
the first and second chamber assemblies. The energizable assembly includes 
an electromagnetic unit which when energized displaces a plunger assembly 
in either one of two opposite directions. Such displacement serves to 
effect fluid transfer either into or out of the first and second chamber 
assemblies simultaneously so as to thereby effect erect or flaccid states 
in the penis depending on the direction of movement of the fluid. In the 
illustrated embodiment, a remote control device is provided which is 
operable for selectively controlling the energizable assembly to operate 
in the described manner. 
In another illustrated embodiment, the first chamber assembly is defined by 
a longitudinally distensible assembly which includes an elongatable 
bellows and which assembly is in fluid communication with the fluid 
transfer assembly. The bellows elongates upon introduction of pressurized 
fluid within the first chamber assembly to thereby effect an erection and 
elongation of the penis. Withdrawal of the fluid from the first chamber 
results in the bellows and thereby the penis returning to a flaccid and 
relatively contracted condition. 
In a further illustrated embodiment, the second chamber assembly is formed 
at a proximal end portion of the prosthesis. The chamber includes an 
expansible bladder having a reservoir for selectively storing the fluid 
and a cage which not only facilitates unimpeded expansion and contraction 
of this chamber, but serves to secure it in the corpus at the penis base. 
In this regard, the cage prevents suction pressure, created on the 
surrounding tissue as a result of evacuation of the reservoir bladder, 
from impeding bladder movement. 
In another illustrated embodiment, the electromagnetic means is operable 
for creating electromagnetic fields which are effective for alternately 
attracting and repelling the plunger assembly. In response to one 
electromagnetic state, the plunger assembly is movable for cooperating 
with a valve means located in a fluid transfer housing for permitting 
fluid in the reservoir or storage chamber to flow through the transfer 
housing and into the expansible first chamber assembly. 
In a still further illustrated embodiment, the electromagnetic means is 
selectively energizable for creating an electromagnetic field which 
displaces the plunger assembly so as to thereby move and cause withdrawal 
of the pressurizing fluid from the first chamber assembly, whereupon the 
fluid travels through the transfer assembly, and ultimately into the 
second chamber assembly. 
In a further embodiment, the plunger includes a body supporting a one 
way-check valve therein and a one-way flap valve. 
Accordingly, among the objects which are provided by the present invention 
are the following: an improved unitary penile prosthetic system which 
includes a penile prothesis of unitary construction and a remote 
controlled unit; an improved penile prothesis which is fully implantable 
and elongatable; an improved penile prosthesis which includes valving 
structure cooperable with a sliding valved plunger for effecting the 
desired fluid transfer to achieve erect and flaccid conditions; and an 
improved unitary prothesis which is simple in construction reliable in 
operation and relatively inexpensive to manufacture. 
Other objects and the full scope of the present invention will become 
apparent upon review of the detailed description to follow when taken in 
conjunction with the accompanying drawings in which like parts are 
designated by like reference numerals throughout the several views.

DETAILED DESCRIPTION 
Reference is made to FIGS. 1-6 for illustrating one preferred embodiment of 
a remote controlled penile prosthetic system 10 which includes a 
completely implantable and unitary penile prosthesis 12, and a hand-held 
remote control device 14 for actuating the former to effect erect and 
flaccid penile conditions. The system 10 is basically operated for 
selectively effecting erect and flaccid conditions of a penis (not shown) 
by controlling flow of a self-contained fluid housed in the prosthesis 12 
between storage and expandable chambers. The fluid can be pressurized air 
or a suitable saline solution. The degree of pressurization determined by 
the amount necessary to achieve the desired prosthetic functions. 
The longitudinally elongated and implantable prosthesis 12 includes 
proximal and distal fluid chambers assemblies 16 and 18; respectively, at 
its opposite ends. Structurally and functionally coupled to and between 
the proximal and distal chamber assemblies 16 and 18 is a fluid transfer 
assembly 20. It is the transfer assembly 20 that is operable by the remote 
control device 14 for effecting displacement of fluid though the assembly 
20 and between the chamber assemblies 16 and 18. As will be described, 
such transfer is effective for causing the noted erect and flaccid penile 
conditions, as a function of whether the fluid is either entering or 
exiting the distal chamber assembly 18. 
Initial reference is made to the proximal fluid chamber assembly 16. The 
chamber assembly 16 includes an expandable fluid reservoir 22 which is 
made of an elongated and expandable bladder of medical grade material, 
such as silicone rubber. Surrounding this fluid bladder or reservoir 22 is 
a cage 24 that is also made of a biocompatible material and which is 
integrally connected at one end thereof to the fluid transfer assembly 20. 
Specifically, the cage 24 has a generally elongated cylindrical shape that 
is constructed by a plurality of circumferentially spaced apart and 
relatively rigid support rods 26 which support the prosthesis 12 in a base 
of the penis, as well as allows the reservoir 22 to unimpedeling expand 
and contract when implanted. 
Reference is now made to the distal chamber assembly 18 which is 
illustrated in FIGS. 1 and 2. The distal chamber assembly 18 is adapted to 
be implanted in a penile corpus cavernosum (not shown). The distal chamber 
assembly 18 is constructed to expand to thereby effect erection and 
elongation of the penis upon the pressurized fluid being received therein. 
Later, the distal chamber assembly 18 collapses upon fluid withdrawal to 
thereby effect a flaccid penile condition. The distal chamber assembly 18 
includes a longitudinal and elongatable outer sheath 30 which is arranged 
to enclose a collapsible and reciprocatable expandable bellows type 
reservoir 32 of limited expendability. The outer sheath 30 is also made of 
a biocompatible plastic material. An anterior bladder 34 defining an 
anterior chamber 34a is centrally positioned within the bellows 32 and 
extends along a portion of a longitudinal axis of the chamber assembly 18. 
The anterior bladder 34 is expandable longitudinally, but does not 
significantly bulge. The bladder 34 includes a port 36 at one end thereof 
for allowing fluid transfer between it and the transfer assembly 20. The 
bellows linearly extends upon longitudinal expansion of the bladder 34, 
but does not necessarily bulge. 
Whenever the distal fluid chamber assembly 18 is void of fluid, it is thus 
in a non-expanded condition (FIG. 1) and the penis will be in a flaccid 
condition (not shown). FIG. 2 on the other hand represents the expanded 
and elongated condition of the reservoir 32 and thus an erect condition 
(not shown) of the penis. To achieve this latter state, the pressurized 
fluid must enter into the anterior bladder 34 through the port 36 leading 
to the anterior chamber 34', whereby the bladder 34, bellows 32, and 
sheath 30 extend longitudinally. This extension effects erection of the 
penis. Because of the folded configuration of the bellows 32, radial 
expansion or bulging thereof is limited. Also, the bellows 32 is, 
preferably, formed of a suitable implant material. It will be appreciated 
that the entire penile prosthesis 10 of the present invention can be 
manufactured in suitable sizes and with a variety of biocompatible 
materials consistent with safe patient usage. 
In order for the penis to return to a flaccid condition, the fluid must be 
expelled from the chamber 34. This occurs, preferably, by remote control 
operation, and as such the expelled fluid travels through the fluid 
transfer assembly 20 into the proximal or reservoir chamber assembly 115 
in a manner to be more fully described hereinafter. 
While the present embodiment describes the utilization of a longitudinally 
extensible bellows type distal chamber for penile elongation, it envisions 
that other types of chambers can be used which can become rigid upon 
pressurized fluid being introduced thereinto to thereby effect an erect 
penile condition. 
Continued reference is made to FIGS. 3-5 for illustrating the fluid 
transfer assembly 20 for effecting the above fluid transfer operations. 
The assembly 20 basically includes a cylindrical housing assembly 38. 
Located at opposite ends thereof are fluid inlet/outlet ports 40, 42. 
Also, an electromagnetic induction assembly 44 is positioned stationarily 
intermediate the chamber assemblies 16 and 18. The electromagnetic 
assembly 44 can be any one of several known types. In this embodiment, it 
basically includes a stationary bobbin 46 defining a central fluid passage 
48 therethrough, a field coil assembly 50 wrapped around the bobbin and 
having a suitable number of turns sufficient for facilitating the 
generation of motive forces. The electromagnetic assembly 44 also includes 
a generally flat annular magnetizable plate 52. A plunger or piston 
assembly 54 comprises a corresponding magnetizable plug 56 associated with 
the plate 52 for effecting an electromagnetic circuit with the coil 
assembly 50 and a plate 52 associated therewith. In this embodiment, 
electric current is induced in the coil 50, preferably, by a remote 
handheld electromagnetic device or wand 58. The remote control wand 58 is 
suitably electrically energized by an appropriate power source (e.g. 
battery) to selectively create different and opposite polarity 
electromagnetic fields. The actuating wand 58, as diagrammatically 
depicted in FIG. 3, includes an electromagnetic assembly 59. The wand 58 
is portable and adapted to be held in proximity to the fluid transfer 
housing 20 for actuating the latter. When the wand assembly 59 is 
energized it selectively creates either a positive or negative 
electromagnetic field. Each field induces a current of a given polarity 
opposing the other. One such field will effect an attractive force between 
the plate 52 and plug 56 which causes the plunger assembly 54 to move 
toward the electromagnetic assembly 44. Actuation of the wand 58 to create 
the opposite polarity causes the assembly 44 to generate a repulsive 
electromagnetic force that is sufficient in magnitude to displace the 
plunger assembly 54 in the opposite direction (as viewed in the drawings) 
for effecting fluid transfer. 
The fluid transfer device includes double-acting valve mechanisms 60, 60; 
each of which cooperates with an appropriate one of the inlet/outlet ports 
40, 42; respectively. As illustrated in FIG. 3, the plunger assembly 54 
normally contacts the valve mechanism 60 for closing the latter. The 
plunger assembly 54 normally retains the depicted position (FIG. 3) in the 
inoperative condition of the prosthesis because of friction between it and 
the housing 38. In this position the plunger assembly 54 urges the annular 
frusto-conical valve plug 62 against a valve seat member 64 secured to the 
housing 38. A biasing spring 66 is interposed between a valve cage 68 
which has a central fluid aperture 69 and the cylindrical valve plug 62. 
The valve plug 62 has a frusto-conical surface 70 which engages the 
complementary shaped valve seat 64 when the plunger 54 compresses the 
spring 66. The valve plug 62 includes a central passage 72 having disposed 
therein a one-.way valve 74. The valve 74 normally retains fluid within 
the reservoir 22, but allows it to pass into the reservoir 22 when the 
latter is being filled, such as when the penis is returning to a flaccid 
condition. The cage 68 includes guide pins 68a which are slidable relative 
to slots (not shown) in the valve seat member 64. When the valve mechanism 
60 is closed, the fluid is retained within the proximal reservoir 22. 
However, under the influence of a magnetic attractive force, the plunger 
54 is moved leftwardly, as viewed in the drawing, towards the 
electromagnetic assembly 44. This allows the valve plug 62 to move to its 
open condition because of the pressurized fluid in the reservoir 22 being 
greater. As a result, fluid can flow from the proximal fluid reservoir 22 
into the housing 38, through the passages 76 and one-way flap valve 78 
that is defined by a resiliently flexible flap valve disc 80. In this 
embodiment, the flap valve 80 has its inner annular periphery secured to 
the central plug 56 which plug and valve define a central passage 82 
extending therethrough which cooperates with a one-way valve 84. Fluid 
leaving the valve 78 then causes a valve mechanism 60, adjacent the 
inlet/outlet 42, to open by displacing its valve plug 62 to overcome the 
bias of a spring 68 and move off a valve seat member 64. As a result, the 
fluid flows into and through inlet/outlet valve 42 to the anterior chamber 
34'. The bellows 32 acts to thereby extend along with the sheath and thus 
effect an erection. 
To return the penis to its flaccid condition, the wand 58 is actuated so 
that it causes the electromagnetic device 44 to generate repulsive 
electromagnetic forces between it and the plunger 54. Movement of the 
plunger 54 in the opposite direction (i.e. rightward as viewed in the 
drawings) creates a relative negative pressure on that side of the valve 
mechanism 60'. This resulting pressure differential occasioned by such 
movement is sufficient for purposes of allowing the pressurized fluid in 
the fluid reservoir 32 to flow through the one-way valve 74 into the 
housing and through the passage 38. Thereafter, the pressurized fluid 
opens the one-way valve 84 of the plunger 54 and the one-way valve 74 
located adjacent the proximal end of the prosthesis. Accordingly, the 
fluid flows freely from the distal reservoir 32 to the proximal or storage 
reservoir 22. 
The present invention also envisions that manual compression of the 
reservoir 32 will generate sufficient pressurize for purposes of moving 
the fluid and opening the noted one-way valves 74, 84, to thereby allow 
the fluid in the reservoir 32 to flow into the proximal reservoir 22. It 
will be understood that manual compression could be used as a safety 
back-up to effect a flaccid condition in event the electromagnetic system 
fails. Thus, the prosthesis 12 need only be operated in a remote mode 
during erection and can rely on manual compression to bring about a return 
to a flaccid penile condition. 
Reference is now made to FIGS. 7 and 8 for purposes of illustrating an 
alternate preferred embodiment of a double-acting valve mechanism 86 which 
is usable in conjunction with the present invention. It will be noted that 
the valve mechanisms 60 and 60 can be replaced by the construction of 
double-acting valve mechanisms 86. The valve mechanism 86 is, preferably, 
plastic and includes a cylindrical member 88 having sidewalls 89 fixedly 
engaged with the inner walls of the housing. A plurality of arcuate fluid 
openings 90 are formed in a top wall 91 of the member 88. The openings 90 
are normally closed by a flexibly resilient flap valve 92 (see solid line 
position) having an annular configuration which is made of rubber or the 
like and which has its inner annular periphery secured to a cone member 
94. In the phantom line position of the drawing the flap valve 92 is in 
the open position. The cone member 94 is hollow and defines a recess 96 
for retaining one-way valve 98 that normally blocks an opening 97. The 
one-way spring biased ball valve 98 itself includes a ball check member 
100 having a generally hemispherical shape and a tapered conical spring 
102. The spring 102 has its wide end supported by and affixed, as by 
adhesive bonding, to radially inward directed ridge 104 of the cone 94. 
The spring 102 serves to normally force the ball check member 100 against 
a complementary shaped valve seat 106 to close opening 97. 
Reference is made to FIG. 9 for illustrating an alternate preferred 
embodiment of a cylindrical plunger assembly 110 which can be substituted 
for the plunger assembly 56. The cylindrical plunger assembly 110 is 
structurally similar to the double-acting valve mechanism 86, but it is 
intended to slide within the transfer housing as opposed to remaining 
stationary therein. The plunger assembly 110 includes a generally 
cylindrical member 112 having a greater height than the corresponding 
height of cylindrical member 88 of the valve mechanism 86. This 
facilitates stable sliding movement of the plunger 110 within the housing. 
A plurality of arcuate openings 111 similar to openings 90 are, 
preferably, formed in a top wall of the member 112. The openings are 
normally closed by a flexibly resilient one-way flap valve 113. The flap 
valve 113 has an annular configuration as the valve 92. Instead of a solid 
central cone extending from the cylinder member 112 as cone 94 there is 
provided a plurality of circumferentially spaced apart legs 114 for 
purposes of reducing plunger weight. The legs 114 house metallic biasing 
spring 102' and a metallic generally hemispherical shaped ball member 
100'. The legs 114 have shoulders 116 upon which the spring is supported 
and fixedly connected. The spring biased ball member 100' serves to close 
a central opening 97' formed at the top of the cylinder member 112. In 
this embodiment, the above noted electromagnetic device 44 will operate 
upon the metallic nature of the spring and ball member to effect the 
attraction or repulsion forces necessary to operate the fluid transfer 
assembly 20. 
Reference is made to FIGS. 10-12 for illustrating another preferred 
embodiment of a fluid transfer assembly 20'. Structure of this embodiment 
which is similar to that of FIGS. 3-5 will be indicated by the same 
reference numerals with the addition of a prime marking. This embodiment 
includes a cylindrical housing assembly 38' having at opposite ends 
thereof inlet/outlet ports 40', 42'. Also, the fluid transfer assembly 20' 
includes on electromagnetic inductor assembly 44' which is positioned 
stationarily intermediate the chamber assemblies 16', 18'. The 
electromagnetic assembly 44' can be any one of several known types. 
Structural and functional details of the operation of the electromagnetic 
assembly 44' are like that described in the first embodiment and need not 
be mentioned. A plunger or piston assembly 54' includes a central body 56' 
having a plurality of central and spaced ribs 55 connecting the former to 
a cylindrical member 57 having its external periphery in slidable and 
sealing engagement within the internal wall of the housing 38'. The 
central body 56' defines a conical recess and passage 82' for a biased 
one-way spring valve member 84'. The metallic spring and ball valve effect 
an electromagnetic circuit with a coil 50' and its associated plate 52' 
for displacing the plunger assembly 54' in opposite directions. Also, in 
this embodiment, the electric current is induced in the coil 50', 
preferably, by the handheld electromagnetic wand 58'. The wand 58' is 
suitably electrically energized by an appropriate power source (e.g. 
battery) to selectively create opposite polarity electromagnetic fields 
having different magnitudes The actuating wand 58', includes an 
electromagnetic assembly 59' and thus a detailed description is not 
necessary for understanding this embodiment since the wand 58' and 
assembly 59' are like that described above in a previous embodiment. 
In this preferred embodiment, a pair of opposed double-acting valve 
mechanisms 60', 60' each of which cooperates with a corresponding one of 
the inlet/outlet ports 40', 42'. These valve mechanisms 60', 60' are 
similar to those described above in connection with FIG. 8. As illustrated 
in FIG. 10, the plunger assembly 54' contacts the valve mechanism 60', so 
as to close the flap valve of the latter. The plunger 54' normally retains 
the depicted position (FIG. 10) when the prosthesis is in the inoperative 
condition because of the friction between it and the inside walls of the 
housing 38'. In this position, the plunger assembly 54' tends to force an 
annular flexibly resilient rubber flap valve 92' against a valve seat 
defined by a cone member 94' so as to cover fluid openings 90'. Also, in 
this embodiment, the cone member 94' is preferably, made of steel. The 
valve mechanisms 60' have peripheral sides 95' and each hollow cone member 
94' is centrally attached to the cylinder 88' and defines a conical recess 
96' and opening 97' for allowing passage of fluid therethrough in a manner 
described above. Each cone member 94' has a plurality of openings 120 
which are adapted not to impede the free flow of the pressurized fluid 
between the valve mechanisms 60', 60' and plunger assembly 54'. Also, the 
cylinder 57 of the plunger 54' is longer than the cylinder 88' of the 
valve mechanism 60'. This results in the radial space between the base of 
the cone and the inside cylinder wall 57 being shorter in the plunger 56' 
than is the comparable space in the valve mechanism 60'. The number and 
size of the openings 120 compensate for the narrower radial passage 
between the outer cylinder wall 57 and the central cone shaped body 56'. 
The operation of this embodiment of the fluid transfer assembly 20' is 
self-evident given the above description of its structure and the 
operations of the previous embodiments. 
Changes may be made in the construction and operation of various elements, 
parts, and assemblies described herein and changes may be made in the 
steps or the sequence of steps of operating the system described herein 
without departing from the spirit and scope of the invention as defined by 
the following claims.