Surgery – Sexual appliance – Male splint
Reexamination Certificate
2001-12-03
2004-05-04
Lacyk, John P. (Department: 3736)
Surgery
Sexual appliance
Male splint
C623S011110
Reexamination Certificate
active
06730017
ABSTRACT:
BACKGROUND
This invention generally relates to a pump and valve assembly for inflating a prosthesis. More particularly, the invention relates to pressure based mechanisms that inhibit spontaneous inflation of the prosthesis, including stiffening and support mechanisms that also improve the function of the valve.
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 (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
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 seat
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.
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 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 may occur. Encapsulation or calcification of the reservoir can lead to additional problems. In particular, the encapsulation could lead to a more snugly enclosed reservoir, thus increasing the likelihood of spontaneous inflation.
In previous attempts to reduce or eliminate the occurrence of spontaneous inflation, different types of spontaneous inflation preventing valves have been introduced into the pump and valve assembly. Such previous valves are intended to permit the positive flow of fluid to the cylinders only in those circumstances when the patient has forcibly manipulated the valve.
Although such previous valve designs reduce the frequency of spontaneous inflation, several drawbacks do exist. For example, such valves are typically complex, requiring two-handed operation which is a serious drawback to elderly or severely ill patients. Some spontaneous inflation preventing valves also require the application of excessive force in order to manipulate the valves; which may be too demanding for some patients. Furthermore, such valve designs may cause patient discomfort due to the valve size or shape, because of increase in the overall volume of the implant within the patient. This increased size can also lead to interference with the patient's normal bodily functions. Such previous valve designs typically add undesirable cost to the device as well as increase the complexity of the surgical implantation procedure.
A solution to the above-identified drawbacks is disclosed in co-pending U.S. patent application Ser. No. 09/749,292 entitled “PRESSURE BASED SPONTANEOUS INFLATION INHIBITOR” which is assigned to the Assignee of the present invention and is incorporated herein by reference. However, the operational efficiency of the prosthesis pump could be further improved by optimizing the operative manipulation of the assembly.
Presently, the pump and valve assemblies used in implantable prostheses share certain characteristics. A compressible pump bulb is attached to the housing and is in fluid communication with the various fluid pathways. In order to inflate the cylinders, the compressible pump bulb is actuated by the patient, thereby urging fluid past the poppets into the cylinders. In order to deflate the cylinders, the valve housing is grasped and squeezed (through the patient's tissue), causing the poppets to unseat and allow fluid to flow back to the reservoir.
Since the pump and valve assembly is positioned within the patient's scrotum, the various components of the assembly must be small. As a result, manipulation of the pump and valve assembly is sometimes difficult. For example, patients requir
Almli John G.
Henkel Gregory J.
Kuyava Charles C.
Morningstar Randy L.
Waldack Larry E.
AMS Research Corporation
Hohenshell Jeffrey J.
Lacyk John P.
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