Surgery – Sexual appliance – Male splint
Reexamination Certificate
2000-12-27
2002-09-03
Winakur, Eric F. (Department: 3736)
Surgery
Sexual appliance
Male splint
C417S441000
Reexamination Certificate
active
06443887
ABSTRACT:
CROSS REFERENCE TO RELATED APPLICATIONS
This application is related to patent applications entitled “PRESSURE BASED SPONTANEOUS INFLATION INHIBITOR IN A PUMP FOR AN INFLATABLE PROSTHESIS” and “DIAPHRAGM 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 switch actuated valve that 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 that are fluidly connected to a fluid (typically liquid) reservoir via a pump and valve assembly. The two cylinders are normally implanted into the corpus cavernosae of the patient and the reservoir is typically implanted in the patient's abdomen. The pump assembly is implanted in the scrotum. During use, the patient actuates the pump and fluid 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 patient 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, resulting in the undesired introduction of fluid into the cylinders. Such inadvertent inflation can be uncomfortable and embarrassing for the patient. 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
U 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 patient 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 serves to reinforce the force from the spring
28
urging the reservoir poppet
20
against valve seal
24
while at the same time causing 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 patient 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
and into the common passageway
33
passing around the reservoir poppet
20
and 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.
To deflate the cylinders, the patient 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
24
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. Complete deflation of the cylinders requires the patient to continuously squeeze housing
12
(hence maintaining the valves in an open position) during the entire deflation process. This can present difficulty for patients lacking manual dexterity. Furthermore, there is only limited tactile feedback to the patient through the valve and housing assembly. Thus, the patient does not necessarily know if they are squeezing too hard or not hard enough to facilitate deflation.
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 and even somewhat excessive reservoir pressures, it is possible that pressure that exceeds the force provided by the springs. could be exerted upon the reservoir during heightened physical activity or movement by the patient. 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. After implantation, encapsulation or calcification of the reservoir could occur. The encapsulation could lead to a more snugly enclosed reservoir, at least temporarily thus increasing the likelihood of spontaneous inflation.
BRIEF SUMMARY OF THE INVENTION
The present invention includes a, pump assembly having a triple poppet arrangement wherein the poppets act as valves, such as check valves or flow valves. The cylinder poppet and the reservoir poppet are spring-biased against a valve seat, and under normal circumstances, only allows positive fluid flow when a pump bulb is compressed, thus causing an increase in fluid pressure Which is transferred to the inflatable cylinders. These two poppets function very similarly to those described with reference to the related art pump. assembly, illustrated in FIG.
1
.
In addition, a switch actuated poppet is provided between the input from the reservoir and the reservoir poppet. The switch actuated poppet is coupled to a rotor and a spring loaded pusher. The spring loaded pusher is positioned adjacent the wall of the housing so that the patient can easily manipulate it, by compressing the outer wall. The interaction of the spring loaded pusher and the rotor act as an “on-off” type switch; much like the locking mechanism in a ball point pen. Namely, with each actuation of the spring loaded pusher, the switch actuated poppet is moved from .one position to another. A momentary single squeeze moves the switch actuated poppet to either a closed position, where it forms a fluid tight seal preventing fluid flow from the reservoir towards the reservoir poppet; or to an open position wherein such fluid flow is permitted.
The switch actuated poppet is easy to operate and requires little force to be applied by the patient, thus permitting one handed operation. In addition, the positive actuation of the switching mechanism. provides a clicking sound and a perceivable tactile sensation that indicates movement and locking
Derus Patricia M.
Hauschild Sidney F.
Huepenbecker George Michael
Polyak Mark
American Medical Systems Inc.
Cadugan Joseph A.
Hohenshell Jeffrey J.
Winakur Eric F.
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