Patent Description:
This application also claims priority to <CIT>.

This disclosure relates generally to bodily implants and more specifically to bodily implants, such as penile prosthesis that includes a bi-directional valve pump.

One treatment for male erectile dysfunction is the implantation of a penile prosthesis that mechanically erects the penis. Some existing penile prostheses include inflatable cylinders or members that can be inflated or deflated using a pump mechanism. The pump mechanism pulls fluid from a fluid reservoir and then transfers the fluid to the inflatable members. According to some existing designs of inflatable penile prostheses, the amount of time, energy and disparity from the occurrence of a normal human male erection for the patient to inflate a penile prosthesis (e.g., the number of pumps and time required to provide the desired penis rigidity) may be relatively high.

Document <CIT> relates to a pump for a body implantable prosthesis that includes a reservoir maintaining a fluid volume that is transferrable into a cylinder. The pump includes a pump bulb, an inlet valve, an exhaust valve, and an anti-auto inflation (AAI) valve. The pump bulb is connected to a pump body that is in fluid communication with the reservoir and the cylinder. The inlet valve is operable to allow a portion of the fluid volume to be drawn from the reservoir and delivered into the pump bulb. The exhaust valve is operable to allow the portion of the fluid volume delivered into the pump bulb to be pumped into the cylinder. The AAI valve is disposed in the pump body and has a seal that is biased to prevent fluid flow from bypassing the pump bulb and flowing from the reservoir to the cylinder.

Document <CIT> relates to an inflatable penile prosthesis (IPP), which includes a rigidly constructed spool valve assembly that is used to direct fluid into and evacuate fluid out of the inflatable penile cylinders. The fluid transfer system transfers fluid from the fluid reservoir to the inflatable penile cylinders and includes the fluid transfer bulb, inlet valve, exhaust valve and spool valve assembly. The cylinder deflate mechanism evacuates fluid from the penile cylinders to the reservoir and includes the deflate actuator, return valve and spool valve assembly.

Document <CIT> shows pump that comprises a fluid reservoir, a pump bulb, a plurality of tubing, and at least one inflatable penile cylinder. The pump comprises a pump body, an inlet valve within the pump body, an exhaust valve within the pump body and in fluid communication with the inlet valve, and a deflate valve within the pump body and in fluid communication with the inlet valve and the exhaust valve. The deflate valve enables one-touch release by (i) providing a voluntarily-activated fluid bypass so that fluid from the at least one inflatable penile cylinder can return to the fluid reservoir through at least one of the plurality of tubing without sustained activation of the deflate valve, and (ii) closing upon subsequent inflation of the at least one inflatable penile cylinder when such inflation is initiated by squeezing the pump bulb so that fluid does not flow back to the fluid reservoir.

Document <CIT> relates to a penis erection assisting device which enables, by means of a simple action of opening a supply switch before having sexual intercourse, an expansion liquid to be supplied to an expansion-type intra-penis substitute by pressure of abdominal walls according to movement of a woman during the sexual intercourse, so that during a natural course of sexual intercourse, injection and discharge of saline solution for the operation of the expansion-type intra-penis substitute can be performed secretly without the partner being able to recognize the injection and discharge.

<CIT> shows an apparatus inserted into the penis of the human body to assist a penile erection, which comprises: a storage unit which is a container capable of storing a fluid therein; an erection unit, as a container capable of storing a fluid therein, communicating with the storage unit and is formed so as to be capable of flexibly changing between a contracted state and a swollen state; an erection inducing unit capable of moving the position of the fluid stored inside the storage unit to the inside of the erection unit; and a contraction induction unit for moving the position of the fluid stored inside the erection unit to the inside of the storage unit, wherein the penis of the human body is erected by the erection inducing unit and the penis of the human body is contracted by the contraction induction unit. According to the present invention, there are effects of rapid penile erection of the human body by moving the position of the fluid from the storage unit to the erection unit, and of rapid penile contraction of the human body if the fluid moves from the erection unit to the storage unit.

The present invention relates to an inflatable penile prosthesis according to claim <NUM> and to a pump assembly for an inflatable penile prosthesis according to claim <NUM>. Further details are defined in the dependent claims.

According to an aspect, an inflatable penile prosthesis includes a fluid reservoir configured to hold fluid, an inflatable member, and a pump assembly configured to transfer the fluid between the fluid reservoir and the inflatable member. The pump assembly includes a valve body, a pump bulb, and a deflation mode actuator. The valve body includes a bi-directional valve configured to move from an inflation position to a deflation position in response to an activation of the deflation mode actuator. The bi-directional valve in the inflation position is configured to open a fluid passageway in the valve body to transfer fluid from the pump bulb to the inflatable member. The bi-directional valve in the deflation position is configured to open a fluid passageway in the valve body to transfer fluid from the inflatable member to the fluid reservoir that bypasses the pump bulb.

According to some aspects, the inflatable penile prosthesis may include one or more of the following features (or any combination thereof), as encompassed by the appended claims. The bi-directional valve may include a control valve ball configured to move between the inflation position and the deflation position. The bi-directional valve may include at least one pusher member operatively coupled to the deflation mode actuator, where the at least one pusher member is configured to cause the control valve ball to move to the deflation position. The at least one pusher member may include a first pusher member operatively coupled to a first deflation button, and a second pusher member operatively coupled to a second deflation button. Actuation of either the first deflation button or the second deflation button may cause the control valve ball to move to the deflation position. The deflation mode actuator may include a feedback component configured to provide at least one of tactile or auditory feedback in response to the activation of the deflation mode actuator. The valve body may include a first surface and a second surface opposite the first surface, and the deflation mode actuator may include a first deflation button extending from the first surface, and a second deflation button extending from the second surface. The pump assembly may include a plurality of fluid transfer ports that extend from the valve body, and the plurality of fluid transfer ports include a reservoir fluid port, a first cylinder fluid port, and a second cylinder fluid port. The valve body may include a refill valve aligned with the reservoir fluid port, where the refill valve is configured to transfer fluid from the fluid reservoir to the pump bulb when the bi-directional valve is in the inflation position. The valve body may include an inflation valve fluidly coupled to the pump bulb. The refill valve and the inflation valve are not used when the bi-directional valve is in the deflation position.

According to an aspect, a pump assembly for an inflatable penile prosthesis includes a valve body including a bi-directional valve, a plurality of fluid transfer ports extending from the valve body, where the plurality of fluid transfer ports include a reservoir fluid port and at least one cylinder fluid port, a pump bulb extending from the valve body, and a deflation mode actuator moveably coupled to the valve body. The bi-directional valve is configured to move from an inflation position to a deflation position in response to an activation of the deflation mode actuator. The bi-directional valve in the inflation position is configured to open a fluid passageway from the pump bulb to the at least one cylinder fluid port. The bi-directional valve in the deflation position is configured to open a fluid passageway from the reservoir fluid port to the at least one cylinder fluid port that bypasses the pump bulb.

According to some aspects, the pump assembly may include one or more of the above/below features (or any combination thereof), as encompassed by the appended claims. The deflation mode actuator may include a deflation button and a feedback component configured to provide at least one of tactile or auditory feedback in response to the deflation button being pressed by a user. The valve body may include a first surface and a second surface opposite the first surface, and the deflation mode actuator may include a first deflation button extending from the first surface, and a second deflation button extending from the second surface. The valve body may include a refill valve disposed in a fluid passageway between the reservoir fluid port and the pump bulb, where the refill valve is aligned along an axis that extends along a longitudinal axis of the reservoir fluid port, and the refill valve is configured to transfer fluid from the fluid reservoir to the pump bulb when the bi-directional valve is in the inflation position. The bi-directional valve may include a control valve ball and at least one pusher member operatively coupled to the deflation mode actuator, where the at least one pusher member is configured to cause the control valve ball to move to the deflation position. The deflation mode actuator may include a first deflation button extending from a first surface of the valve body, and a second deflation button extending from a second surface of the valve body. The at least one pusher member may include a first pusher member operatively coupled to the first deflation button, and a second pusher member operatively coupled to the second deflation button. The valve body may include a refill valve, and an inflation valve, where the refill valve and the inflation valve are not used when the bi-directional valve is in the deflation position.

According to an aspect, a method for controlling a direction of fluid through a pump assembly of an inflatable penile prosthesis includes transferring, by a pump assembly, fluid from a fluid reservoir to an inflatable member, including transferring the fluid from the fluid reservoir to a pump bulb via a refill valve and transferring the fluid from the pump bulb to the inflatable member via an inflation valve and a bi-directional valve. The method includes moving the bi-directional valve to a deflation position in response to activation of a deflation mode actuator, and transferring the fluid from the inflatable member to the fluid reservoir via the bi-directional valve such that the fluid is not transferred through the pump bulb. In some examples, the refill valve and the inflation valve are not used to transfer the fluid from the inflation member to the fluid reservoir when the bi-directional valve is in the deflation position.

Detailed embodiments are disclosed herein. However, it is understood that the disclosed embodiments are merely examples, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the embodiments in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting, but to provide an understandable description of the present disclosure.

The terms "a" or "an," as used herein, are defined as one or more than one. The term "another," as used herein, is defined as at least a second or more. The terms "including" and/or "having", as used herein, are defined as comprising (i.e., open transition). The term "coupled" or "moveably coupled," as used herein, is defined as connected, although not necessarily directly and mechanically.

In general, the embodiments are directed to bodily implants. The term patient or user may hereafter be used for a person who benefits from the medical device or the methods disclosed in the present disclosure. For example, the patient can be a person whose body is implanted with the medical device or the method disclosed for operating the medical device by the present disclosure.

<FIG> illustrates an inflatable penile prosthesis <NUM> including a fluid reservoir <NUM>, an inflatable member <NUM>, and a pump assembly <NUM> configured to transfer fluid between the fluid reservoir <NUM> and the inflatable member <NUM> according to an aspect. The inflatable member <NUM> may be implanted into the corpus cavernosae of the user, the fluid reservoir <NUM> may be implanted in the abdomen or pelvic cavity of the user (e.g., the fluid reservoir <NUM> may be implanted in the lower portion of the user's abdominal cavity or the upper portion of the user's pelvic cavity), and the pump assembly <NUM> may be implanted in the scrotum of the user.

The pump assembly <NUM> includes a pump bulb <NUM>, a valve body <NUM>, a deflation mode actuator <NUM>, and fluid transfer ports such as a reservoir fluid port <NUM> fluidly coupled to the fluid reservoir <NUM> (via a first conduit connector <NUM>) and one or more cylinder fluid ports <NUM> fluidly coupled to the inflatable member <NUM> (via a second conduit connector <NUM>). The fluid transfer ports may extend from an end portion of the valve body <NUM>. In some examples, the fluid transfer ports are disposed on (or defined by) a fluid transfer member that is separate from the valve body <NUM>, where the fluid transfer member is coupled to the valve body <NUM>. In some examples, the reservoir fluid port <NUM> includes an elongated tubular member defining a cavity. In some examples, the cylinder fluid ports <NUM> includes a first cylinder fluid port fluidly connected to a first cylinder member of the inflatable member <NUM>, and a second cylinder fluid port fluidly connected to a second cylinder member of the inflatable member <NUM>. In some examples, the cylinder fluid ports <NUM> include elongated tubular members that define cavities.

The valve body <NUM> includes a bi-directional valve <NUM> configured to move from an inflation position to a deflation position in response to an activation of the deflation mode actuator <NUM>. The bi-directional valve <NUM> may include a directional control valve and a movable component (e.g., ball, poppet, spool etc.) that moves between the inflation position and the deflation position with respect to the directional control valve in order to control the direction of the fluid through the fluid passageways of the valve body. In some examples, the bi-directional valve <NUM> includes a two-way two-position direction control valve. In some examples, the design of the bi-directional valve <NUM> may reduce (or eliminate) the possibility for the pump bulb <NUM> to get stuck in a collapsed state even if the first squeeze to switch from the deflation mode to the inflation mode does not successfully move the bi-directional valve <NUM> to the inflation position.

When the bi-directional valve <NUM> is in the inflation position, the inflatable penile prosthesis <NUM> is in an inflation mode (or inflation cycle). When the bi-directional valve <NUM> is in the deflation position, the inflatable penile prosthesis <NUM> is in a deflation mode (or deflation cycle). In some examples, a single, instantaneous push of the deflation mode actuator <NUM> transfers the bi-directional valve <NUM> to the deflation position (e.g., as opposed to holding the deflation mode actuator <NUM> for a certain predetermined time). In some examples, movement of the bi-directional valve <NUM> to the deflation position causes a fluid pathway (e.g., the dashed arrow <NUM> in <FIG>) to open between the cylinder fluid ports <NUM> and the reservoir fluid port <NUM> such that fluid can be transferred from the inflatable member <NUM> back to the fluid reservoir <NUM> via the pump assembly <NUM> in a manner that bypasses the pump bulb <NUM>.

In contrast, in the inflation mode, the pump bulb <NUM> is used to transfer fluid from the fluid reservoir <NUM> to the inflatable member <NUM> (e.g. the pump bulb <NUM> is not bypassed). For example, the user may depress (or squeeze) the pump bulb <NUM> and then release the pump bulb <NUM>, and then repeat these operations until the desired rigidity is achieved in the inflatable member <NUM>. As shown by the non-dashed arrow <NUM> in <FIG>, the release of the pump bulb <NUM> creates a suction force that pulls fluid from the fluid reservoir <NUM> to the pump bulb <NUM>, and the depression of the pump bulb <NUM> expels the fluid from the pump bulb <NUM> to the inflatable member <NUM>. In some examples, in the inflation mode, the valve body <NUM> provides an optimized fluid passageway via the bi-directional valve <NUM> that may decrease the pressure drop across the bi-directional valve <NUM> for faster inflate time and/or decrease the fluid resistance thereby requiring less pump bulb squeeze force to inflate.

The pump bulb <NUM> may be a flexible member defining a cavity. The pump bulb <NUM> is coupled to and extends from the valve body <NUM>. In some examples, the pump bulb <NUM> extends from the valve body <NUM> in a direction that is opposite to the direction in which the reservoir fluid port <NUM> and the cylinder fluid ports <NUM> extend from the valve body <NUM> (e.g., located on opposite ends of the valve body <NUM>). The pump bulb <NUM> may be a squeeze pump. In some examples, the pump bulb <NUM> includes ribbing or dimples to aid the user in gripping the pump bulb <NUM>. As indicated above, the pump bulb <NUM> may use suction and pressure to move the fluid in and out of the cavity of the pump bulb <NUM> in the inflation mode. For example, the user may depress or squeeze the pump bulb <NUM> to expel the fluid out of the cavity, and, when the flexible member returns to its original shape, the resulting suction pushes the fluid into the cavity of the pump bulb <NUM>. In some examples, the pump bulb <NUM> may have a bulb spring rate that is designed to refill the pump bulb <NUM> in a selected time frame.

The valve body <NUM> defines one or more fluid passageways through the valve body <NUM> (e.g., between the reservoir fluid port <NUM> and the pump bulb <NUM>, the pump bulb <NUM> and the cylinder fluid ports <NUM>, and the cylinder fluid ports <NUM> and the reservoir fluid port <NUM>). The valve body <NUM> includes valve components disposed within the fluid passageways to control the flow of the fluid through the valve body <NUM> in the inflation mode and the deflation mode. In some examples, the valve body <NUM> includes a block of material that defines the fluid passageways and encloses the valve components. In some examples, the valve body <NUM> includes a silicone material. In some examples, the valve body <NUM> may be molded from a silicone material having a medium durometer value. In some examples, the pump assembly <NUM> includes an outer protective casing that is disposed over the valve body <NUM>. In some examples, the outer protective casing has a material (e.g., a polymer material) that is different from the valve body <NUM>. In some examples, the outer protective casing includes one or more tactile features that help the user locate the valve body <NUM> (in order to locate the deflation mode actuator <NUM>). In some examples, the tactile features include protruded portions, ridges, grooves, bumps, and/or depressions.

The valve body <NUM> includes the bi-directional valve <NUM>, a refill valve <NUM>, and an inflation valve <NUM>. In some examples, the valve body <NUM> includes an anti-auto inflate valve. The refill valve <NUM> may be used when the pump bulb <NUM> is refilled. The refill valve <NUM> is not used in the deflation mode. In some examples, the refill valve <NUM> is a one-way valve. In some examples, the refill valve <NUM> is disposed in a fluid passageway within the valve body <NUM> between the reservoir fluid port <NUM> and the pump bulb <NUM>. In some examples, the fluid passageway having the refill valve <NUM> that extends between the reservoir fluid port <NUM> and the pump bulb <NUM> is used only for refilling the pump bulb <NUM> (e.g., a separated fluid pathway), which may decrease bulb refill time (e.g., deceases the wait time between squeezes).

In some examples, the refill valve <NUM> is aligned with the reservoir fluid port <NUM>. For example, the refill valve <NUM> may have an inlet and an outlet, where fluid enters the inlet from the reservoir fluid port <NUM> and exits the outlet to the pump bulb <NUM>. The reservoir fluid port <NUM> may define a longitudinal axis that extends along the fluid pathway (e.g., between the inlet and the outlet) of the refill valve <NUM>. The alignment of the refill valve <NUM> with the reservoir fluid port <NUM> may minimize fluid pathway tortuosity, and/or decrease pressure drop across the refill valve <NUM>. In some examples, the refill valve <NUM> includes a floating check ball with fluting (which may increase or maximize fluid velocity across the refill valve <NUM>). In some examples, the refill valve <NUM> includes a biasing member that biases the refill valve <NUM> to a sealing position. In some examples, the biasing member includes a spring. In some examples, the refill valve <NUM> does not include a biasing member.

The inflation valve <NUM> may be disposed within a fluid passageway between the pump bulb <NUM> and the cylinder fluid ports <NUM>. The inflation valve <NUM> may be used during the inflation of the inflatable member <NUM> (e.g., when the fluid is transferred from the pump bulb <NUM> to the inflatable member <NUM>). The inflation valve <NUM> is not used during the deflation mode. In some examples, the inflation valve <NUM> is a one-way valve. In some examples, the inflation valve <NUM> includes a check ball and a biasing member. The biasing member may bias the check ball to a sealing position. In some examples, the biasing member includes a spring. In some examples, the bi-directional valve <NUM> is disposed within a fluid passageway between the inflation valve <NUM> and the cylinder fluid ports <NUM>. In some examples, the bi-directional valve <NUM> is aligned within the inflation valve <NUM>.

In some examples, the bi-directional valve <NUM> includes a control valve ball that is configured to move from the inflation position to the deflation position (e.g., move in a linear direction). In some examples, the bi-directional valve <NUM> includes a poppet that is configured to move from the inflation position to the deflation position (and vice versa) (e.g., move in a linear direction). In some examples, the bi-directional valve <NUM> includes one or more pusher members operatively coupled to the deflation mode actuator <NUM>. In some examples, the pusher members include cam pushers. In some examples, actuation of deflation mode actuator <NUM> causes the pusher member to move, which moves the control valve ball or poppet to the deflation position. In some examples, the pusher member moves in a direction orthogonal to the movement of the control valve ball or the poppet. In some examples, the bi-directional valve <NUM> includes a directional control valve (e.g., a rotating member, a swirl pot), where the pusher member moves (e.g., rotates) the directional control valve causing the control valve ball or the poppet to translate in a linear direction to the deflation position. In some examples, the directional control valve is a swirl pot. In some examples, the pusher members include a first pusher member operatively coupled to one deflation mode actuator <NUM>, and a second pusher member operatively coupled to another deflation mode actuator <NUM>. In some examples, in response to the deflation mode actuator <NUM> being pressed, the first pusher member moves within the valve body <NUM>, contacts the swirl pot, and then rotates the swirl pot causing the control valve ball or the poppet to move to the deflation position. In response to the other deflation mode actuator <NUM> being pressed, the second pusher member moves within the valve body <NUM>, contacts the swirl pot, and then rotates the swirl pot causing the control valve ball or the poppet to move to the deflation position.

In the inflation position (and when the user is operating the pump bulb <NUM>), the fluid may flow from the reservoir fluid port <NUM> (from the fluid reservoir <NUM>) to the pump bulb <NUM> via the refill valve <NUM>, and from the pump bulb <NUM> to the cylinder fluid port <NUM> via the inflation valve <NUM> and the bi-directional valve <NUM> (and then to the inflatable member <NUM>) as shown by the non-dashed arrow <NUM> of <FIG>. Upon activation of the deflation mode actuator <NUM>, the bi-directional valve <NUM> may open a fluid passageway in the valve body <NUM> to transfer fluid from the inflatable member <NUM> to the fluid reservoir that bypasses the pump bulb <NUM> as shown by the dashed arrow <NUM> of <FIG>.

In some examples, when the control valve ball of the bi-directional valve <NUM> is in the deflation position, the refill valve <NUM> and the inflation valve <NUM> are not used (e.g., the refill valve <NUM> and the inflation valve <NUM> are bypassed as well). For example, movement of the bi-directional valve <NUM> from the inflation position to the deflation position causes a fluid passageway to open between the cylinder fluid ports <NUM> and the reservoir fluid port <NUM> such that fluid can be transferred through the valve body <NUM> in a manner that the pump bulb <NUM>, the refill valve, and/or the inflation valve <NUM> are bypassed. In some examples, when the bi-directional valve <NUM> is in the deflation position, the bi-directional valve <NUM> directs the fluid flow from the cylinder fluid ports <NUM> to the reservoir fluid port <NUM>. In some examples, upon actuation of the deflation mode actuator <NUM>, the control valve ball of the bi-directional valve <NUM> moves from the inflation position to the deflation position (e.g., a linear direction towards the pump bulb <NUM>).

The deflation mode actuator <NUM> is movably coupled to the valve body <NUM>. In some examples, the deflation mode actuator <NUM> includes a deflation button, that when pressed, causes the control ball of the bi-directional valve <NUM> to move to the deflation position. In some examples, the deflation mode actuator <NUM> includes a push rod. In some examples, the user presses the deflation mode actuator <NUM> once (e.g., does not need to hold the deflation mode actuator <NUM>) to cause fluid to drain from the inflatable member <NUM>. In some examples, due to the pressure inside of the inflatable member <NUM>, some of the fluid may be automatically transferred from the inflation member <NUM> to the fluid reservoir <NUM> via the pump assembly <NUM>, and then the user may squeeze the inflatable member <NUM> to transfer some of the remaining fluid in the inflatable member <NUM>.

In some examples, the valve body <NUM> includes multiple deflation mode actuators <NUM> on sides (or surfaces) of the valve body <NUM>. For example, some users of conventional pump designs have experienced difficulties with locating the deflation button, which may cause patient frustration as well as increased training time for the physician, and in some cases, prolonged erections for those patients that need medical intervention to press the deflation button and release fluid from the cylinders.

However, in some examples, one deflation mode actuator <NUM> may be disposed on (or extending from) a first surface <NUM> of the valve body <NUM>, and another deflation mode actuator <NUM> may be disposed on (or extending from) a second surface <NUM> of the valve body <NUM>, where the second surface <NUM> is disposed opposite to the first surface <NUM>. A user may press either of the deflation mode actuators <NUM> to place the bi-directional valve <NUM> in the deflation position (e.g., each may independently cause the bi-directional valve <NUM> to be placed in the deflation position).

In some examples, the valve body <NUM> includes more than two deflation mode actuators <NUM>. In some examples, a separate deflation mode actuator <NUM> may exist on each of the four side surfaces of the valve body <NUM>. For example, the valve body <NUM> may be a valve block, where the pump bulb <NUM> extends from one end surface, and the fluid transfer ports extends from the other end surface, and each of the four surfaces between the end surfaces include a separate deflation mode actuator <NUM> (e.g., a first deflation button, a second deflation button, a third deflation button, and a fourth deflation button). In some examples, the deflation mode actuators <NUM> can independently cause the bi-directional valve <NUM> to move to the deflation position. With the design of the bi-directional valve <NUM>, the user has more flexibility in the way the deflation mode actuators <NUM> are manually located and actuated. In addition, the pump assembly <NUM> has the potential to rotate in the scrotum post implantation, which may be another benefit of having deflation mode actuators <NUM> on multiple different sides (e.g., <NUM> or <NUM> different sides) of the valve body <NUM>.

In some examples, the deflation mode actuator <NUM> includes a feedback component <NUM> configured to provide at least one of tactile or auditory feedback in response to the activation of the deflation mode actuator <NUM>. For example, when the deflation mode actuator <NUM> is pressed, the feedback component <NUM> may provide a sound and/or tactile feeling that the inflatable penile prosthesis <NUM> has entered the deflation mode. In some examples, the feedback component <NUM> is located between the deflation button and a pusher member, and when the feedback component <NUM> is compressed, the feedback component <NUM> is configured to provide tactile and/or auditory feedback indicating that the inflatable penile prosthesis <NUM> has entered the deflation mode. In some examples, the feedback component <NUM> includes a dome component.

Each of the first conduit connector <NUM> and the second conduit connector <NUM> may define a lumen configured to transfer the fluid to and from the pump assembly <NUM>. The first conduit connector <NUM> may be coupled to the pump assembly <NUM> and the fluid reservoir <NUM> such that fluid can be transferred between the pump assembly <NUM> and the fluid reservoir <NUM> via the first conduit connector <NUM>. For example, the first conduit connector <NUM> may define a first lumen configured to transfer fluid between the pump assembly <NUM> and the fluid reservoir <NUM>. The first conduit connector <NUM> may include a single or multiple tube members for transferring the fluid between the pump assembly <NUM> and the fluid reservoir <NUM>.

The second conduit connector <NUM> may be coupled to the pump assembly <NUM> and the inflatable member <NUM> such that fluid can be transferred between the pump assembly <NUM> and the inflatable member <NUM> via the second conduit connector <NUM>. For example, the second conduit connector <NUM> may define a second lumen configured to transfer fluid between the pump assembly <NUM> and the inflatable member <NUM>. The second conduit connector <NUM> may include a single or multiple tube members for transferring the fluid between the pump assembly <NUM> and the inflatable member <NUM>. In some examples, the first conduit connector <NUM> and the second conduit connector <NUM> may include a silicone rubber material. In some examples, the pump assembly <NUM> may be directly connected to the fluid reservoir <NUM>.

The inflatable member <NUM> may be capable of expanding upon the injection of fluid into a cavity of the inflatable member <NUM>. For instance, upon injection of the fluid into the inflatable member <NUM>, the inflatable member <NUM> may increase its length and/or width, as well as increase its rigidity. In some examples, the inflatable member <NUM> may include a pair of inflatable cylinders or at least two cylinders, e.g., a first cylinder member and a second cylinder member. The volumetric capacity of the inflatable member <NUM> may depend on the size of the inflatable cylinders. In some examples, the volume of fluid in each cylinder may vary from about <NUM> milliliters in smaller cylinders and to about <NUM> milliliters in larger sizes. In some examples, the first cylinder member may be larger than the second cylinder member. In other examples, the first cylinder member may have the same size as the second cylinder member.

The fluid reservoir <NUM> may include a container having an internal chamber configured to hold or house fluid that is used to inflate the inflatable member <NUM>. The volumetric capacity of the fluid reservoir <NUM> may vary depending on the size of the inflatable penile prosthesis <NUM>. In some examples, the volumetric capacity of the fluid reservoir <NUM> may be <NUM> to <NUM> cubic centimeters. In some examples, the fluid reservoir <NUM> is constructed from the same material as the inflatable member <NUM>. In other examples, the fluid reservoir <NUM> is constructed from a different material than the inflatable member <NUM>. In some examples, the fluid reservoir <NUM> contains a larger volume of fluid than the inflatable member <NUM>.

<FIG> illustrate various perspectives of a pump assembly <NUM> having a bi-directional valve <NUM> configured to move from an inflation position to a deflation position to open a fluid passageway that transfers fluid from an inflatable member to a fluid reservoir in a manner that bypasses a pump bulb <NUM>. In some examples, the pump assembly <NUM> is an example of the pump assembly <NUM>, and may include any of the features discussed with reference to the inflatable penile prosthesis <NUM> of <FIG>.

<FIG> illustrates the pump assembly <NUM> according to an aspect. <FIG> illustrates a perspective of the pump assembly <NUM> having the bi-directional valve <NUM> in an inflation position according to an aspect. <FIG> illustrates a perspective of the pump assembly <NUM> having the bi-directional valve <NUM> in a deflation position according to an aspect. <FIG> illustrates a first cross-section of the bi-directional valve <NUM> according to an aspect. <FIG> illustrates a second cross-section of the bi-directional valve <NUM> according to an aspect. <FIG> illustrates a third cross-section of the bi-directional valve <NUM> according to an aspect. <FIG> illustrates a double cross-section of the bi-directional valve <NUM> according to an aspect.

The pump assembly <NUM> includes a valve body <NUM>, the pump bulb <NUM>, deflation buttons such as a first deflation button <NUM>-<NUM>, a second deflation button <NUM>-<NUM>, a third deflation button <NUM>-<NUM>, and a fourth deflation button (not shown), and fluid ports such as a first cylinder fluid port <NUM>, a second cylinder fluid port <NUM>, and a reservoir fluid port <NUM>. In some examples, the pump bulb <NUM> extends from the valve body <NUM> in a first direction, and the fluid transfer ports extend from the valve body <NUM> in a second direction, where the second direction is opposite to the first direction. For example, the pump bulb <NUM> and the fluid transfer ports may extend on opposite ends of the valve body <NUM>.

The reservoir fluid port <NUM> is configured to be connected to the first conduit connector <NUM> of <FIG>, and the first cylinder fluid port <NUM> and the second cylinder fluid port <NUM> are configured to be connected to the second conduit connector <NUM> of <FIG>. The first cylinder fluid port <NUM> may include a first tubular member defining a cavity. The second cylinder fluid port <NUM> may include a second tubular member defining a cavity. The reservoir fluid port <NUM> may include a third tubular member defining a cavity. In some examples, the first tubular member, the second tubular member, and the third tubular member are disposed parallel to each other. In some examples, the third tubular member (e.g., the reservoir fluid port <NUM>) has a length longer than a length of the second tubular member and/or a length of the first tubular member.

The valve body <NUM> includes a first surface <NUM> and a second surface <NUM> disposed opposite to the first surface <NUM>. For example, the first surface <NUM> and the second surface <NUM> may be disposed on opposite sides of the valve body <NUM>. The first deflation button <NUM>-<NUM> may be disposed on (or extending from) the first surface <NUM> of the valve body <NUM>. The second deflation button <NUM>-<NUM> may be disposed on (or extending from) the second surface <NUM> of the valve body <NUM>. The valve body <NUM> includes a third surface <NUM> and a fourth surface (not shown) disposed opposite to the third surface <NUM>. For example, the third surface <NUM> and the fourth surface may be disposed on opposite sides of the valve body <NUM>. The third deflation button <NUM>-<NUM> may be disposed on (or extending from) the third surface <NUM> of the valve body <NUM>. The fourth deflation button may be disposed on (or extending from) the fourth surface of the valve body <NUM>.

A user may press one or more than one of the first deflation button <NUM>-<NUM>, the second deflation button <NUM>-<NUM>, the third deflation button <NUM>-<NUM>, and the fourth deflation button to move the bi-directional valve <NUM> to the deflation position. In some examples, a single instantaneous push of one of the deflation buttons causes the bi-directional valve <NUM> to move to the deflation position. In some examples, the user presses two opposing deflation buttons (e.g., the first deflation button <NUM>-<NUM> and the second deflation button <NUM>-<NUM>, or the third deflation button <NUM>-<NUM> and the fourth deflation button) to cause the bi-directional valve <NUM> to move to the deflation position.

The valve body <NUM> includes the bi-directional valve <NUM>, a refill valve <NUM>, an inflation valve <NUM>, and an anti-auto inflate valve <NUM>. In some examples, the refill valve <NUM> is disposed in a fluid passageway <NUM> within the valve body <NUM> between the reservoir fluid port <NUM> and the pump bulb <NUM> (shown in <FIG>). In some examples, the fluid passageway <NUM> is a passageway that is dedicated to only refilling the pump bulb <NUM> (e.g., not used to transfer fluid to the inflatable member or during deflation). For example, with respect to a pump refilling operation, the releasing of the pump bulb <NUM> causes a suction force that pulls the fluid from the fluid reservoir, through the reservoir fluid port <NUM>, and through the valve body <NUM>. In the valve body <NUM>, the fluid is transferred along the fluid passageway <NUM> via the refill valve <NUM> to the pump bulb <NUM>. In some examples, the refill valve <NUM> is aligned with the reservoir fluid port <NUM>. The reservoir fluid port <NUM> may define a longitudinal axis <NUM> that is aligned with the refill valve's fluid passageway. The alignment of the refill valve <NUM> with the reservoir fluid port <NUM> may minimize fluid pathway tortuosity, and/or decrease pressure drop across the refill valve <NUM>. In some examples, the refill valve <NUM> includes a floating check ball with fluting (which may increase or maximize fluid velocity across the refill valve <NUM>).

The inflation valve <NUM> may be disposed in a fluid passageway that extends from (and/or or proximate to) to the pump bulb <NUM>. In some examples, the inflation valve <NUM> includes a check ball and a biasing member. In examples, the biasing member includes a spring. In some examples, the bi-directional valve <NUM> is aligned with the inflation valve <NUM>. In some examples, the anti-auto inflate valve <NUM> is aligned the bi-directional valve <NUM>. In some examples, the bi-directional valve <NUM> is disposed between the anti-auto inflate valve <NUM> and the inflation valve <NUM>.

The bi-directional valve <NUM> may include a control valve ball <NUM>, a swirl pot <NUM>, and pusher members <NUM>. The control valve ball <NUM> may linearly move between the inflation position (as shown in <FIG>) and the deflation position (as shown in <FIG>). The pusher members <NUM> are coupled to the deflation buttons. In some examples, one pusher member <NUM> is coupled to a respective deflation button. For example, the first deflation button <NUM>-<NUM> is coupled to one pusher member <NUM>, the second deflation button <NUM>-<NUM> is coupled to another pusher member <NUM>, the third deflation button <NUM>-<NUM> is coupled to another pusher member <NUM>, and the fourth deflation button is coupled to another pusher member <NUM>. Upon activation of one of the deflation buttons, the corresponding pusher member <NUM> may move causing the swirl pot <NUM> to rotate to move the control valve ball <NUM> to the deflation position (e.g., the control valve ball <NUM> moves in a direction towards the pump bulb <NUM>). In some examples, the pusher members <NUM> move in a direction orthogonal (e.g., perpendicular) to a direction in which the control valve ball <NUM> moves. In order to switch back to the inflation mode, the user may squeeze the pump bulb <NUM> that creates a pressure force that forces the control valve ball <NUM> to move back to the inflation position, thereby rotating the swirl pot <NUM> in the opposite direction.

In the inflation mode (as shown in <FIG>), the user squeezes the pump bulb <NUM> to transfer fluid from the pump bulb <NUM> to the first cylinder fluid port <NUM> and the second cylinder fluid port <NUM> via the valve body <NUM>. In the inflation mode, the control valve ball <NUM> is in the inflation position. The fluid travels from the pump bulb <NUM>, through the inflation valve <NUM>, and the control valve ball <NUM> (in the inflation position) causes the fluid to flow through a fluid passageway <NUM> to the first cylinder fluid port <NUM> and through a fluid passageway <NUM> to the second cylinder fluid port <NUM>. This fluid passageway (e.g., the fluid pathways from the pump bulb <NUM> to the cylinder fluid ports <NUM>, <NUM>) may decrease the pressure drop across the bi-directional valve <NUM> for faster inflate time, and reduce the amount of fluid resistance thereby requiring less pump bulb squeeze force. In the inflation mode, the anti-auto inflate valve <NUM> is not used. Then, the user releases the pump bulb <NUM>, which causes the refilling operation as described above with respect to the refill valve <NUM>. The user repeats these operations until a desired rigidity is achieved in the inflatable member.

In order to switch to the deflation mode, the user locates and presses one or more of the deflation buttons, which causes a particular pusher member <NUM> to move, thereby forcing the control valve ball <NUM> to the deflation position, as shown in <FIG>. For example, the pusher member <NUM> may rotate the swirl pot <NUM> causing the control valve ball <NUM> to move to the deflation position (e.g., the control valve ball <NUM> moves in a direction towards the pump bulb <NUM>). In the deflation mode, the fluid is transferred from the inflatable member back to the fluid reservoir. For example, the fluid enters the first and second cylinder fluid ports <NUM>, <NUM>, and travels through the valve body <NUM> to the reservoir fluid port <NUM>. In the valve body <NUM>, the control valve ball <NUM> of the bi-directional valve <NUM> directs the fluid through the anti-auto inflate valve <NUM> to the reservoir fluid port <NUM>. In contrast to the inflation mode (or cycle), this fluid passageway bypasses the pump bulb <NUM>. Also, the refill valve <NUM> and the inflation valve are not used in the deflation mode.

<FIG> illustrates a cross-section of a bi-directional valve <NUM> according to an aspect. The bi-directional valve <NUM> may be similar to the bi-directional valve <NUM> and the bi-directional valve <NUM> (and may include any of the features discussed herein), but the bi-directional valve <NUM> includes a poppet <NUM> (instead of a control valve ball) disposed within a valve body <NUM>. For example, the bi-directional valve <NUM> includes a swirl pot <NUM>, and the poppet <NUM> is movable with respect to the swirl pot <NUM>. In <FIG>, the poppet <NUM> is in the inflation position. The bi-directional valve <NUM> includes a first pusher member <NUM>-<NUM> (coupled to a first deflation button), and a second pusher member <NUM>-<NUM> (coupled to a second deflation button). When the first deflation button is pressed, the first pusher member <NUM>-<NUM> moves towards the swirl pot <NUM> in a direction <NUM>, contacts the swirl pot <NUM>, and then rotates the swirl pot <NUM> causing the poppet <NUM> to move in a direction <NUM>. In some examples, the direction <NUM> is orthogonal (e.g., perpendicular) to the direction <NUM>. When the second deflation button is pressed, the second pusher member <NUM>-<NUM> moves towards the swirl pot <NUM> in a direction <NUM>, contacts the swirl pot <NUM>, and then rotates the swirl pot <NUM> causing the poppet <NUM> to move in the direction <NUM>. In some examples, the direction <NUM> is orthogonal (e.g., perpendicular) to the direction <NUM>. In some examples, the direction <NUM> is parallel (but opposite) to the direction <NUM>.

<FIG> and <FIG> illustrate various perspectives of a pump assembly <NUM> according to an aspect. <FIG> illustrates a perspective of the pump assembly <NUM> according to an aspect. <FIG> illustrates a perspective of the pump assembly <NUM> according to another aspect. The pump assembly <NUM> may include any of the features described with reference to the previous figures. In some examples, the pump assembly <NUM> includes a fluid port member <NUM> that is separate from the valve body <NUM>. However, the fluid port member <NUM> is coupled to the valve body <NUM>. In some examples, the fluid port member <NUM> is coupled to the valve body <NUM> based on an interference fit. In some examples, the fluid port member <NUM> and the valve body <NUM> are coupled together using fasteners and/or a bonding material.

The fluid port member <NUM> includes a first cylinder fluid port <NUM>, a second cylinder fluid port <NUM>, and a reservoir fluid port <NUM>. Also, the fluid port member <NUM> includes a base <NUM>. The base <NUM> may be the foundational part or edge of the fluid port member <NUM> (e.g., the part on which it is supported). In some examples, the base <NUM> has a rectangular shape (with curved corners). However, the base <NUM> may include other shapes such as circular or non-circular shapes. The valve body <NUM> includes a base <NUM>. The base <NUM> of the valve body <NUM> may have a shape/structure that corresponds to the shape/structure of the base <NUM>. In some examples, the base <NUM> has a rectangular shape. However, the base <NUM> may include other shapes such as circular or non-circular shapes. The base <NUM> of the fluid port member <NUM> and the base <NUM> of the valve body <NUM> are configured to be coupled to each other.

The pump assembly <NUM> includes a pump bulb <NUM> that extends from the valve body <NUM> at a location opposite to the base <NUM>. The valve body <NUM> includes a first deflation button <NUM>-<NUM>, a second deflation button <NUM>-<NUM>, a third deflation button <NUM>-<NUM>, and a fourth deflation button <NUM>-<NUM> that are disposed on (or extending from) different side surfaces of the valve body <NUM>.

As shown in <FIG>, the base <NUM> includes a raised portion <NUM> that defines a first opening <NUM>, a second opening <NUM>, and a third opening <NUM>. The first opening <NUM>, the second opening <NUM>, and the third opening <NUM> extend into the valve body <NUM>. Also, the base <NUM> includes a first protrusion that defines a fourth opening <NUM> and a second protrusion that defines a fifth opening <NUM>. The raised portion <NUM> may be disposed between the fourth opening <NUM> and the fifth opening <NUM>. In some examples, the first opening <NUM>, the second opening <NUM>, the third opening <NUM>, the fourth opening <NUM>, and the fifth opening <NUM> may be disposed parallel to each other.

As shown in <FIG>, at a location underneath the base <NUM>, the base <NUM> defines a cavity <NUM> having shapes that correspond to the shapes of the raised portion <NUM>, the first protrusion that defines the fourth opening <NUM>, and the second protrusion that defines the fifth opening <NUM>. For example, the cavity <NUM> includes a first cavity section <NUM>, a second cavity section <NUM>, and a third cavity section <NUM>, which are configured to receive the raised portion <NUM> defining the first opening <NUM>, the second opening <NUM>, and the third opening <NUM>, respectively. Also, the cavity includes a fourth cavity section <NUM> and a fifth cavity section <NUM>, which are configured to receive the first protrusion that defines the fourth opening <NUM> and the second protrusion that defines the fifth opening <NUM>.

<FIG> illustrates various perspectives of a feedback component <NUM> configured to provide at least one of tactile or auditory feedback in response to the activation of a deflation button <NUM> according to an aspect. <FIG> illustrates the feedback component <NUM> as a dome structure <NUM> according to an aspect. In some examples, the dome structure <NUM> includes a rounded vault and a circular base. In some examples, when the dome structure <NUM> is compressed, the dome structure <NUM> may create a sound. In some examples, when the dome structure <NUM> is compressed, the dome structure <NUM> may provide a tactile sensation that is perceptible by the user. For example, the feedback component <NUM> may be integrated with the deflation button <NUM> such that when the user presses the deflation button <NUM>, the feedback component <NUM> may provide a sound and/or tactile sensation that inform the user that the inflatable penile prosthesis is on the deflation mode.

<FIG> illustrates the feedback component <NUM> disposed on an end surface <NUM> of a pusher member <NUM> according to an aspect. When the deflation button <NUM> is pressed, the deflation button <NUM> moves the pusher member <NUM> in order to place the bi-directional valve in the deflation position. When the bi-direction valve is in the deflation position, the pusher member <NUM> is prevented from further movement, and the pusher member <NUM> and the deflation button <NUM> compress the feedback component <NUM>, which causes the feedback component <NUM> to provide at least one of tactile or auditory feedback.

<FIG> illustrates a flow chart <NUM> depicting example operations of a method of controlling a direction of fluid through a pump assembly of an inflatable penile prosthesis according to an aspect. Although the flow chart <NUM> is explained with reference to the inflatable penile prosthesis <NUM> of <FIG>, the example operations of the flow chart <NUM> may be performed by any of inflatable penile prostheses, pump assemblies, and/or bi-directional valves discussed herein.

Operation <NUM> includes transferring, by a pump assembly, fluid from a fluid reservoir to an inflatable member. For example, the pump assembly <NUM> may transfer fluid from the fluid reservoir <NUM> to the inflatable member <NUM>. The transferring includes transferring the fluid from the fluid reservoir <NUM> to a pump bulb <NUM> via a refill valve <NUM>, and transferring the fluid from the pump bulb <NUM> to the inflatable member <NUM> via an inflation valve <NUM> and a bi-directional valve <NUM>.

Operation <NUM> includes moving the bi-directional valve to a deflation position in response to activation of a deflation mode actuator. For example, the bi-directional valve <NUM> may be moved to the deflation position in response to the activation of the deflation mode actuator <NUM>.

Operation <NUM> includes transferring the fluid from the inflatable member to the fluid reservoir via the bi-directional valve such that the fluid is not transferred through the pump bulb. For example, the fluid is transferred from the inflatable member <NUM> to the fluid reservoir <NUM> via the bi-directional valve such that the fluid is not transferred through the pump bulb <NUM>.

<FIG> schematically illustrates an inflatable penile prosthesis <NUM> having a pump assembly <NUM> according to an aspect. The pump assembly <NUM> may include any of the features of the pump assemblies described with reference to the previous figures. The penile prosthesis <NUM> may include a pair of inflatable cylinders <NUM>, and the inflatable cylinders <NUM> are configured to be implanted in a penis. For example, one of the inflatable cylinders <NUM> may be disposed on one side of the penis, and the other inflatable cylinder <NUM> may be disposed on the other side of the penis. Each inflatable cylinder <NUM> may include a first end portion <NUM>, a cavity or inflation chamber <NUM>, and a second end portion <NUM> having a rear tip <NUM>.

The pump assembly <NUM> may be implanted into the patient's scrotum. A pair of conduit connectors <NUM> may attach the pump assembly <NUM> to the inflatable cylinders <NUM> such that the pump assembly <NUM> is in fluid communication with the inflatable cylinders <NUM>. Also, the pump assembly <NUM> may be in fluid communication with a fluid reservoir <NUM> via a conduit connector <NUM>. The fluid reservoir <NUM> may be implanted into the user's abdomen. The inflation chamber or portion <NUM> of the inflatable cylinder <NUM> may be disposed within the penis. The first end portion <NUM> of the inflatable cylinder <NUM> may be at least partially disposed within the crown portion of the penis. The second end portion <NUM> may be implanted into the patient's pubic region PR with the rear tip <NUM> proximate the pubic bone PB.

In order to implant the inflatable cylinders <NUM>, the surgeon first prepares the patient. The surgeon often makes an incision in the penoscrotal region, e.g., where the base of the penis meets with the top of the scrotum. From the penoscrotal incision, the surgeon may dilate the patient's corpus cavernosae to prepare the patient to receive the inflatable cylinders <NUM>. The corpus cavernosum is one of two parallel columns of erectile tissue forming the dorsal part of the body of the penis, e.g., two slender columns that extend substantially the length of the penis. The surgeon will also dilate two regions of the pubic area to prepare the patient to receive the second end portion <NUM>. The surgeon may measure the length of the corpora cavernosae from the incision and the dilated region of the pubic area to determine an appropriate size of the inflatable cylinders <NUM> to implant.

After the patient is prepared, the penile prosthesis <NUM> is implanted into the patient. The tip of the first end portion <NUM> of each inflatable cylinder <NUM> may be attached to a suture. The other end of the suture may be attached to a needle member (e.g., Keith needle). The needle member is inserted into the incision and into the dilated corpus cavernosum. The needle member is then forced through the crown of the penis. The surgeon tugs on the suture to pull the inflatable cylinder <NUM> into the corpus cavernosum. This is done for each inflatable cylinder <NUM> of the pair. Once the inflation chamber <NUM> is in place, the surgeon may remove the suture from the tip. The surgeon then inserts the second end portion <NUM>. The surgeon inserts the rear end of the inflatable cylinder <NUM> into the incision and forces the second end portion <NUM> toward the pubic bone PB until each inflatable cylinder <NUM> is in place.

A pump bulb <NUM> of the pump assembly <NUM> may be squeezed or depressed by the user in order to facilitate the transfer of fluid from the fluid reservoir <NUM> to the inflatable cylinders <NUM>. For example, in the inflation mode, while the user is operating the pump bulb <NUM>, the pump bulb <NUM> may receive the fluid from the fluid reservoir <NUM>, and then output the fluid to the inflatable cylinders <NUM>. When the user switches to the deflation mode, at least some of the fluid can automatically be transferred back to the fluid reservoir <NUM> (due to the difference in pressure from the inflatable cylinders <NUM> to the fluid reservoir <NUM>). Then, the user may squeeze the inflatable cylinders <NUM> to facilitate the further transfer of fluid through the pump bulb <NUM> to the fluid reservoir <NUM>.

Claim 1:
An inflatable penile prosthesis (<NUM>) comprising:
a fluid reservoir (<NUM>) configured to hold fluid;
an inflatable member (<NUM>); and
a pump assembly (<NUM>) configured to transfer the fluid between the fluid reservoir (<NUM>) and the inflatable member (<NUM>), the pump assembly (<NUM>) including a valve body (<NUM>), a pump bulb (<NUM>), and a deflation mode actuator (<NUM>),
the valve body (<NUM>) including a bi-directional valve (<NUM>) configured to move from an inflation position to a deflation position in response to an activation of the deflation mode actuator (<NUM>),
the bi-directional valve (<NUM>) in the inflation position configured to open a fluid passageway in the valve body (<NUM>) to transfer fluid from the pump bulb (<NUM>) to the inflatable member (<NUM>),
the bi-directional valve (<NUM>) in the deflation position configured to open a fluid passageway in the valve body (<NUM>) to transfer fluid from the inflatable member (<NUM>) to the fluid reservoir (<NUM>) that bypasses the pump bulb (<NUM>), characterized in that
the deflation mode actuator (<NUM>) includes a first deflation button (<NUM>-<NUM>) extending from a first surface (<NUM>) of the valve body (<NUM>), and a second deflation button (<NUM>-<NUM>) extending from a second surface (<NUM>) of the valve body (<NUM>).