Surgery – Sexual appliance – Male splint
Reexamination Certificate
2000-12-27
2003-03-18
Hindenburg, Max F. (Department: 3736)
Surgery
Sexual appliance
Male splint
C623S023670
Reexamination Certificate
active
06533719
ABSTRACT:
CROSS REFERENCE TO RELATED APPLICATIONS
This application is related to patent applications entitled “SLIDE VALVE AND SUCTION BASED SPONTANEOUS INFLATION INHIBITOR IN A PUMP FOR AN INFLATABLE PROSTHESIS” and “SWITCH BASED SPONTANEOUS INFLATION INHIBITOR IN A PUMP FOR AN INFLATABLE PROSTHESIS,” which were filed concurrently herewith.
BACKGROUND OF THE INVENTION
This invention generally relates to a pump for inflating a prostheses and more particularly to a pump and valve assembly including a diaphragm which inhibits spontaneous inflation of the prosthesis.
One common treatment for male erectile dysfunction is the implantation of a penile prosthesis. Such a prosthesis typically includes a pair of inflatable cylinders which are fluidly connected to a fluid reservoir via a pump and valve assembly. The two cylinders are normally implanted into the corpus cavernosae of the user and the reservoir is typically implanted in the user's abdomen. The pump assembly is implanted in the scrotum. During use, the user actuates the pump and fluid (typically liquid) is transferred from the reservoir through the pump and into the cylinders. This results in the inflation of the cylinders and thereby produces the desired penis rigidity for a normal erection. Then, when the user desires to deflate the cylinders, a valve assembly within the pump is actuated in a manner such that the fluid in the cylinders is released back into the reservoir. This deflation then returns the penis to a flaccid state,
With inflatable penile prostheses of current designs, spontaneous inflation of the cylinders is known to occasionally occur due to inadvertent compression of the reservoir. Specifically, this inadvertent compression results in the undesired introduction of fluid into the cylinders. While this does not create a medical or physical problem, such inadvertent inflation can be uncomfortable and embarrassing for the user. This undesirable condition is further described below with reference to a particular prosthetic design.
With reference to
FIG. 1
, a known pump and valve assembly
8
for use in a penile prosthesis includes a fluid input
10
that is coupled at one end to a reservoir (not shown) and to a housing
12
at its opposite end. Also connected to the housing
12
is a fluid output
14
which, in turn, is connected at its other end to a pair of cylinders (not shown). Linking the fluid input
10
and the fluid output
14
to each other is a common passageway
33
, which itself contains a valve assembly that is described in greater detail below. Common passageway
33
is also in fluid communication with a pump bulb
18
that is used to move fluid from the reservoir (not shown) to the cylinders (not shown) in order to inflate the cylinders. The valve assembly located within common passageway
33
includes a reservoir poppet
20
which is biased against a valve seat
24
by a spring
28
and a cylinder poppet
22
which is biased against a valve seat
26
by a spring
30
. The springs
28
and
30
are sized so as to keep the reservoir poppet
20
and the cylinder poppet
22
biased against each respective valve seat
24
and
26
under the loads that are encountered when the reservoir is pressurized to typical abdominal pressures.
When the user wishes to inflate the cylinders, pump bulb
18
is squeezed so as to force fluid from the pump bulb
18
into the common passageway
33
. The resulting fluid flow creates a fluid pressure on reservoir poppet
20
which compliments the force of the spring
28
to hold the reservoir poppet
20
against valve seal
24
. The fluid flow also causes compression of the spring
30
, and thereby opening cylinder poppet
22
. As a result, the fluid travels out through fluid output
14
and into the respective cylinders.
When the user releases the pump bulb
18
a vacuum is created, thus pulling the poppet
22
back against valve seat
26
(aided by spring
30
) and simultaneously pulling the reservoir poppet
20
away from its valve seat
24
, against the spring
28
. As a result, fluid from the reservoir is thus allowed to flow through the fluid input
10
to the common passageway
33
, passing around the reservoir poppet
20
. Fluid then will freely flow into the vacuous pump bulb
18
. Once the pump bulb
18
has been filled, the negative pressure is eliminated and the reservoir poppet
20
returns to its normal position. This pumping action of the pump bulb
18
and valve assembly is repeated until the cylinders are fully inflated as desired.
To deflate the cylinders, the user grips the housing
12
and compresses it along the axis of reservoir poppet
20
and cylinder poppet
22
in a manner such that the wall
13
of the housing
12
contacts the protruding end
21
of the reservoir poppet
20
and forces the reservoir poppet
20
away from valve seat
24
. This movement, in turn, causes the reservoir poppet
20
to contact cylinder poppet
22
and force cylinder poppet
22
away from valve seat
26
. As a result, both poppets
20
and
22
are moved away from their valve seats
21
and
26
and fluid moves out of the cylinders, through the fluid output
14
, through common passageway
33
, through the fluid input
10
and back into the reservoir.
Although the springs
28
and
30
are sized to provide sufficient tension to keep poppets
20
and
22
firmly abutted against valve seats
24
and
26
under normal reservoir pressures, it is possible for fluid pressure to exceed the force provided by the springs during heightened physical activity or movement by the user. Specifically, this activity or movement can apply excess pressure to the reservoir. Such excessive pressure on the reservoir may overcome the resistance of the spring-biased poppets
20
and
22
and thereby cause a spontaneous inflation of the cylinders. Encapsulation or calcification of the reservoir can sometimes occur in a patient. This encapsulation could lead to a more snugly enclosed reservoir, thus increasing the possibility of providing excess pressure on the reservoir and the likelihood of spontaneous inflation.
As such, there exists a need to provide a prosthetic penile implant having a spontaneous inflation prevention mechanism that is reliable and easy to operate.
BRIEF SUMMARY OF THE INVENTION
The present invention includes a penile pump having a dual poppet arrangement wherein the poppets act as check valves or flow valves. Each poppet is spring-biased against a valve seat, and under normal circumstances, only allows positive fluid flow when a pump bulb is engaged. To prevent spontaneous inflation when an overpressurization occurs in the reservoir, the same reservoir pressure is utilized to seal the fluid output against itself or to seal one or both of the poppets against the valve seat. Thus, the fluid is prevented from reaching the cylinders and creating a spontaneous inflation. When the movement or activity generating the overpressure in the reservoir is released, the system will return to an equilibrium and allow normal operation. Even if overpressurization of the reservoir is occurring, the pressure generated by compressing the pump bulb will far exceed the level of overpressure. Thus, the poppets will open in the normal way, allowing fluid to flow to the cylinders.
The use of the overpressure in the reservoir itself to prevent fluid flow to the cylinders can be accomplished in a variety of formats. Each of these formats however, generally utilize a structure in fluid communication with the reservoir which is capable of restricting flow caused by reservoir overpressurization.
In a first embodiment, a bypass passageway is provided from the fluid input which terminates in an expansion chamber located directly behind the cylinder poppet. A portion of the housing forms a wall between this chamber and the cylinder poppet. This wall is larger in surface area than the surface area of the cylinder poppet exposed to the overpressure. Since the surface area of the wall is larger than the area of the poppet that contacts the valve seat, the same amount of pressure generated by the reservoir
Clark David W.
Kuyava Charles C.
Westrum, Jr. John W.
AMS Research Corporation
Cadugan Joseph A.
Hindenburg Max F.
Hohenshell Jeffrey J.
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