Patent Description:
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. The pump mechanism may include a pump bulb and a valve body that includes one or more valve components. According to some existing designs of inflatable penile prostheses, the complexity of the valve components may cause the pump bulb to get struck in a collapsed state, where the user may have to deform the valve block in order to dislodge one or more valve components until fluid is able to pass around them to refill the pump bulb.

Document <CIT> discloses a 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.

According to document <CIT>, an IPP includes unbiased one-way check valve assemblies either independently or in conjunction with other valve assemblies to direct fluid into and evacuate fluid out of inflatable penile cylinders. The fluid transfer system transfers fluid from the fluid reservoir to inflatable penile cylinders and includes a fluid transfer bulb, unbiased inlet valve assembly, unbiased exhaust valve assembly and spool valve assembly. The cylinder deflate mechanism evacuates fluid from the penile cylinders to the reservoir and includes a deflate actuator, unbiased return valve assembly, and spool valve assembly.

The invention consists in an inflatable penile prosthesis according to claim <NUM> and a pump according to claim <NUM>.

According to an aspect of the disclosure, 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 pump bulb, a valve body, a push valve movably coupled to the valve body, a first fluid port configured to be fluidly coupled to the fluid reservoir, and a second fluid port configured to be fluidly coupled to the fluid reservoir. The push valve includes a movable valve element configured to move between an inflation position and a deflation position within a bore of the valve body. The movable valve element in the inflation position defines a fluid passageway through the bore to transfer fluid from the pump bulb to the second fluid port. The movable valve element, when moved to the deflation position, is configured to change the fluid passageway through the bore to transfer fluid from the second fluid port to the first fluid port such that the pump bulb is bypassed.

According to some aspects of the disclosure, the inflatable penile prosthesis may include one or more of the following features (or any combination thereof). The push valve may include a biasing member that biases the movable valve element to the inflation position. The push valve may include a poppet having a ring member. The movable valve element is configured to move to the deflation position in a linear direction based on a single instantaneous push of the movable valve element by a user. The pump assembly may include a button component that encloses a portion of the movable valve element when the movable valve element is in the inflation position. The pump assembly may include a feedback component disposed between the button component and the movable valve element, where the feedback component is configured to provide at least one of tactile or auditory feedback in response to the movable valve element being moved to the deflation position. A portion of the movable valve element may extend outside the valve body when the movable valve element is in the inflation position, and the portion of the movable valve element may be disposed inside the valve body when the movable valve element is in the deflation position. The valve body may include a refill valve aligned with the first fluid port, and the refill valve is configured to transfer fluid from the fluid reservoir to the pump bulb when the movable valve element is in the inflation position. The valve body may include an inflation valve disposed in a fluid passageway between the pump bulb and the bore. The movable valve element may include a first movable member and a second movable member, where the first movable member and the second movable member are configured to independently move with respect to each other. 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 movable valve element is in the deflation position.

According to an aspect of the disclosure, a pump assembly for an inflatable penile prosthesis includes a push valve movably coupled to a valve body, where the push valve includes a movable valve element configured to move between an inflation position and a deflation position within a bore of the valve body, and a plurality of fluid transfer ports including a first fluid port configured to be fluidly coupled to a fluid reservoir, and a second fluid port configured to be fluidly coupled to an inflatable member. The movable valve element in the inflation position defines a fluid passageway through the bore to transfer fluid from a pump bulb to the second fluid port. The movable valve element, when moved to the deflation position, is configured to change the fluid passageway through the bore to transfer fluid from the second fluid port to the first fluid port such that the pump bulb is bypassed.

According to some aspects of the disclosure, the pump assembly may include any of the above/below features (or any combination thereof). The movable valve element may include a cylindrical unitary body having at least two sections with different diameters. The first fluid port includes a first tubular member, and the second fluid port includes a second tubular member and a third tubular member. The second tubular member is configured to be fluidly coupled to a first cylinder member of the inflatable member, and the third tubular member is configured to be fluidly coupled to a second cylinder member of the inflatable member. The pump assembly includes a refill valve disposed within the valve body at a location that is aligned with a longitudinal axis of the first fluid port, and an inflation valve disposed in a fluid passageway between the bore and the pump bulb. The movable valve element is configured to move from the inflation position to the deflation position along an axis, where the axis is substantially orthogonal to the longitudinal axis of the first fluid port. The pump assembly may include an anti-auto inflate valve disposed in a fluid passageway between the first fluid port and the second fluid port. A portion of the movable valve element may extend outside the valve body when the movable valve element is in the inflation position, and the pump assembly may further include a button component that encloses the portion of the movable valve element, and a feedback component disposed between the button component and an end portion of the movable valve element. The feedback component is configured to provide at least one of tactile or auditory feedback in response to the movable valve element being moved to the deflation position.

According to an aspect not forming part of the invention, 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 push valve having a movable valve element. The method includes pushing the movable valve element along an axis to a deflation position to change a fluid passageway through a valve body of the pump assembly, and transferring the fluid from the inflatable member to the fluid reservoir via the push 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 movable valve element 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 push valve <NUM> movably coupled to the valve body <NUM>, a first fluid port <NUM> fluidly coupled to the fluid reservoir <NUM> (via a first conduit connector <NUM>), and a second fluid port <NUM> fluidly coupled to the inflatable member <NUM> (via a second conduit connector <NUM>). The first fluid port <NUM> and the second fluid port <NUM> 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 tube adaptor (e.g., a triple tube adaptor) that is separate from the valve body <NUM>, and the tube adaptor is coupled to the valve body <NUM>. In some examples, the first fluid port <NUM> includes an elongated tubular member defining a cavity. In some examples, the second fluid port <NUM> includes two separate elongated tubular members (e.g., one tubular member being fluidly coupled to a first cylinder member of the inflatable member <NUM> and another tubular member being fluidly coupled to a second cylinder member of the inflatable member <NUM>).

The push valve <NUM> is configured to move from an inflation position to a deflation position along an axis <NUM> within a bore of the valve body <NUM> when pressed by a user in order to control the direction of the fluid through the fluid passageways of the valve body <NUM>. The push valve <NUM> includes a movable valve element <NUM> and a biasing member <NUM> that biases the movable valve element <NUM> to the inflation position. In some examples, the movable valve element <NUM> is configured to move to the deflation position in a linear direction based on a single instantaneous push of the movable valve element <NUM> by a user. The pump assembly <NUM> includes a button component <NUM> that encloses a portion of the movable valve element <NUM> when the movable valve element <NUM> is in the inflation position. The button component <NUM> may be a flexible button-shaped material that extends over the movable valve element <NUM>.

In some examples, the movable valve element <NUM> includes a directional control valve. In some examples, the movable valve element <NUM> includes an elongated cylindrical body having at least two sections with different sizes. In some examples, the movable valve element <NUM> includes one or more ring members (e.g., annular rings or retainer rings). In some examples, the biasing member <NUM> includes a spring. In some examples, the movable valve element <NUM> includes a single unitary body (e.g., a single cylindrical member). In some examples, the movable valve element <NUM> includes a two-piece member (e.g., first and second movable members that are concentrically aligned and move independently of each other).

The design of the push 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 movable valve element <NUM> to the inflation position. When the movable valve element <NUM> is in the inflation position, the inflatable penile prosthesis <NUM> is in an inflation mode (or inflation cycle). When the movable valve element <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 movable valve element <NUM> transfers the inflatable penile prosthesis <NUM> to the deflation position (e.g., as opposed to pressing and holding the movable valve element <NUM> for a certain predetermined time). In some examples, movement of the movable valve element <NUM> to the deflation position causes a fluid pathway to open between the second fluid port <NUM> and the first fluid port <NUM> such that fluid can be transferred from the inflatable member <NUM> 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>. 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>. 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 push valve <NUM> that may decrease the pressure drop across the push 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 first fluid port <NUM> and the second fluid port <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>. 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 push valve <NUM>). In some examples, the tactile features include protruded portions, ridges, grooves, bumps, and/or depressions.

The valve body <NUM> includes 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 first fluid port <NUM> and the pump bulb <NUM>. In some examples, the fluid passageway having the refill valve <NUM> that extends between the first 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 fluidly coupled to the bore (where the push valve <NUM> moves within) and the pump bulb <NUM>.

In some examples, the refill valve <NUM> is aligned with the first fluid port <NUM>. For example, the refill valve <NUM> may have an inlet and an outlet, where fluid enters the inlet from the first fluid port <NUM> and exits the outlet to the pump bulb <NUM>. The first fluid port <NUM> may define a longitudinal axis <NUM> that extends along the fluid pathway (e.g., between the inlet and the outlet) of the refill valve <NUM>. In some examples, the longitudinal axis <NUM> is orthogonal to the axis <NUM>. The alignment of the refill valve <NUM> with the first 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 push valve <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 the inflation position (and when the user is operating the pump bulb <NUM>), the fluid may flow from the first 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 second fluid port <NUM> via the inflation valve <NUM> and the push valve <NUM> (and then to the inflatable member <NUM>). In response to the movable valve element <NUM> being pressed to the deflation position, the position in the movable valve element <NUM> within the bore of the valve body <NUM> may 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>. For example, the movable valve element <NUM>, when moved to the deflation position, is configured to change the fluid passageway through the bore to transfer fluid from the second fluid port <NUM> to the first fluid port <NUM> such that the pump bulb <NUM> is bypassed. 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 pump assembly <NUM> includes a feedback component disposed between the button component <NUM> and the movable valve element <NUM>. The feedback component is configured to provide at least one of tactile or auditory feedback in response to the activation of the movable valve element <NUM> being moved to the deflation position. For example, when the movable valve element <NUM> is pressed, the feedback component 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 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 push 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>. For example, a user may push the push valve <NUM> to place the penile prosthesis in a deflation mode. In the inflation position, the pump assembly <NUM> transfers fluid from the fluid reservoir to the inflatable member via the pump bulb <NUM>. However, in the deflation position, the pump assembly <NUM> transfers fluid from the inflatable member to the fluid reservoir that bypasses the pump bulb <NUM>. In some examples, the push valve <NUM> is a switching valve. In some examples, the pump assembly <NUM> is an example of the pump assembly <NUM> of <FIG>, and may include any of the features discussed with reference to the inflatable penile prosthesis <NUM> of <FIG>. Also, the pump assembly <NUM> of <FIG> may include any of the features with respect to the pump assembly <NUM> of <FIG> though 2E.

<FIG> illustrates an exterior of the pump assembly <NUM> according to an aspect. <FIG> illustrates a perspective of the pump assembly <NUM> with the push valve <NUM> in an inflation position according to an aspect. <FIG> illustrates a perspective of the pump assembly <NUM> with the push valve <NUM> in a deflation position according to an aspect. <FIG> illustrates a cross-section of a valve body <NUM> of the pump assembly <NUM> with the push valve <NUM> in the deflation position according to an aspect. <FIG> illustrates a view of the valve body <NUM> of the pump assembly <NUM> with the push valve <NUM> in the deflation position according to an aspect.

The pump assembly <NUM> includes a pump bulb <NUM>, the valve body <NUM>, the push valve <NUM>, a button component <NUM>, and fluid transfer ports such as a first cylinder fluid port <NUM>, a second cylinder fluid port <NUM>, and a fluid reservoir port <NUM>. The fluid reservoir 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> includes a first tubular member defining a cavity. The second cylinder fluid port <NUM> includes a second tubular member defining a cavity. The fluid reservoir port <NUM> includes 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 pump assembly <NUM> includes a tube adaptor <NUM>. In some examples, the tube adaptor <NUM> is a triple tube adaptor. The tube adaptor <NUM> may be a unitary body (e.g., a single piece of material) that defines the first cylinder fluid port <NUM>, the second cylinder fluid port <NUM>, and the fluid reservoir port <NUM>. For example, the tube adaptor <NUM> may be manufactured separately from the valve body <NUM>, but coupled together during the assembly of the pump assembly <NUM>. The tube adaptor <NUM> is coupled to the valve body <NUM>. In some examples, the tube adaptor <NUM> is coupled to the valve body <NUM> using an interference fit. In some examples, the tube adaptor <NUM> is coupled to the valve body <NUM> using an adhesive material and/or one or more fasteners.

The pump bulb <NUM> may extend from a first end portion <NUM> of the valve body <NUM>, and the fluid transfer ports may extend from a second end portion <NUM> of the valve body <NUM>. The valve body <NUM> includes a side surface <NUM> that extends on one side of the valve body <NUM> between the first end portion <NUM> and the second end portion <NUM>. The button component <NUM> may extend from the side surface <NUM> and cover the push valve <NUM>. A user may press the button component <NUM> to move the push valve <NUM> to the deflation position. In some examples, a single instantaneous push of the push valve <NUM> causes the push valve <NUM> to move to the deflation position (and stay in the deflation position). For example, the user may not need to hold the push valve <NUM> for a predetermined period of time in order to move the push valve <NUM> to the deflation position.

The valve body <NUM> includes passageways and valve components. The valve body <NUM> may include a silicone material. For example, the valve body <NUM> may be molded from a silicone material having a medium durometer value. The valve body <NUM> includes the push valve <NUM>, a refill valve <NUM>, an inflation valve <NUM>, and an anti-auto inflate valve <NUM>. The anti-auto inflate valve <NUM> is shown with respect to <FIG>.

The push valve <NUM> includes a movable valve element <NUM> and a biasing member <NUM> that biases the movable valve element <NUM> to the inflation position (as shown in <FIG>). The button component <NUM> may be a flexible button-shaped material that extends over the movable valve element <NUM>. In some examples, the button component <NUM> may be considered a portion of the valve body's housing extends from the side surface <NUM> of the valve body <NUM>. The biasing member <NUM> is biased to its elongated length, and, upon depression of movable valve element <NUM>, the biasing member <NUM> compresses to a shorter length (or compressed state). In some examples, the biasing member <NUM> includes a spring. In some examples, the movable valve element <NUM> includes an elongated cylindrical valve member. In some examples, the movable valve element <NUM> includes a poppet. In some examples, the movable valve element <NUM> includes a directional control valve. The movable valve element <NUM> includes a first end portion <NUM>, a ring member <NUM>, and a second end portion <NUM>. The ring member <NUM> may be a circular portion that extends around a portion of the shaft of the movable valve element <NUM>. In some examples, the ring member <NUM> includes an annular ring. In some examples, the ring member <NUM> includes a retainer ring. The ring member <NUM> is disposed on the movable valve element <NUM> at a location between the first end portion <NUM> and the second end portion <NUM>. In some examples, the first end portion <NUM> includes a ring member. In some examples, the second end portion <NUM> includes a ring member. In some examples, the second end portion <NUM> has a size (e.g., diameter) smaller than a size (e.g., diameter) of the first end portion <NUM>. In some examples, the first end portion <NUM> has a length (e.g., extending along an axis <NUM>) longer than a length (e.g., extending along the axis <NUM>) of the second end portion <NUM>. In some examples, the push valve <NUM> (or the valve body <NUM> in general) includes a directional control valve.

The movable valve element <NUM> (or a portion thereof) is movable within a main bore <NUM> defined by the valve body <NUM>. For example, in the inflation position, the first end portion <NUM> of the movable valve element <NUM> extends from the side surface <NUM> (but is covered by the button component <NUM>). In some examples, the main bore <NUM> is a cylindrical cavity. The user may press the movable valve element <NUM> in the main bore <NUM> along the axis <NUM> to the deflation position (as shown in <FIG>). In some examples, the button component <NUM> then flexes back to its original shape while the movable valve element <NUM> remains in the deflation position. In the deflation position, the edge of the second end portion <NUM> of the movable valve element <NUM> may be disposed adjacent to (or contact) a protrusion extending from the end of the main bore <NUM> with the biasing member <NUM> being compressed. In some examples, in the deflation position, the first end portion <NUM> of the movable valve element <NUM> is disposed within the valve body <NUM> (or substantially aligned with the side surface <NUM> of the valve body <NUM>).

The pressure in the inflatable member may hold the movable valve element <NUM> in the deflation position (e.g. cylinder pressure seats the push valve <NUM>). In some examples, the main bore <NUM> may include one or more protrusions that contact the ring member <NUM> (and/or another portion of the movable valve element <NUM>) to hold the movable valve element <NUM> in the deflation position (e.g., preventing the biasing member <NUM> from pushing the movable valve element <NUM> to the inflation position). In order to switch to the inflation mode, the user may squeeze the pump bulb <NUM> and the resulting pressure causes the movable valve element <NUM> to move back to the inflation position. For example, as shown in <FIG>, the portion of the main bore <NUM> disposed between the ring member <NUM> and the end of the main bore <NUM> defines an activation force pressure area <NUM>. When the user squeezes the pump bulb <NUM>, pressure inside of the activation force pressure area <NUM> increases, which forces the movable valve element <NUM> to switch to the inflation position.

The anti-auto inflate valve <NUM> is disposed within a post area <NUM> of the valve body <NUM>. The post area <NUM> may be considered a refill and anti-auto inflate post area. For example, the post area <NUM> is a fluid passageway area that transfers fluid from the fluid reservoir port <NUM> to refill the pump bulb <NUM> (in the inflation mode) and also transfers fluid to the fluid reservoir port <NUM> (in the deflation mode). In some examples, the anti-auto inflate valve <NUM> includes a check ball. In some examples, the anti-auto inflate valve <NUM> includes a check ball and a biasing member (e.g., a spring).

The refill valve <NUM> is disposed in a fluid passageway within the valve body <NUM> between the fluid reservoir port <NUM> and the pump bulb <NUM>. The refill valve <NUM> is used to transfer fluid in the inflation mode, but not used to transfer fluid in the deflation mode. In some examples, the refill valve <NUM> is a one-way valve. The refill valve <NUM> may include a floating check ball. In some examples, the refill valve <NUM> includes a floating check ball with fluting to increase and/or maximize fluid velocity across valve. In some examples, the refill valve <NUM> is aligned with the fluid reservoir port <NUM>. As shown in <FIG>, the fluid reservoir port <NUM> defines a longitudinal axis <NUM> and the refill valve <NUM> is aligned along the longitudinal axis <NUM>. For example, in the inflation mode, fluid flows through the refill valve <NUM> to the pump bulb <NUM>, and the refill valve <NUM> is positioned along an axis that is aligned with the longitudinal axis <NUM> of the fluid reservoir port <NUM>. The refill valve <NUM> being in-line with the fluid reservoir port <NUM> may minimize fluid pathway tortuosity, and may decrease the pressure drop across the refill valve <NUM> to increase refill time. In some examples, the refill valve <NUM> and the anti-auto inflate valve <NUM> are disposed within the same fluid passageway within the valve body <NUM>. In some examples, the refill valve <NUM> is aligned with the anti-auto inflate valve <NUM>. For example, a longitudinal axis of the refill valve <NUM> may be substantially aligned with a longitudinal axis of the anti-auto inflate valve <NUM>.

The inflation valve <NUM> is disposed within a fluid passageway within the valve body <NUM> between the main bore <NUM> and the pump bulb <NUM>. The inflation valve <NUM> is used to transfer fluid during the inflation mode, but not used to transfer fluid in 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 that biases the inflation valve <NUM> to a sealing position. In some examples, the biasing member of the inflation valve <NUM> is a spring. In some examples, the size of the check ball of the inflation valve <NUM> is smaller than the size of the check ball of the refill valve <NUM>. In some examples, the smaller check ball and relatively light spring of the inflation valve <NUM> may decrease the squeeze force required to overcome the spring load.

In the inflation position (as shown in <FIG>), the pump bulb <NUM> is used to transfer fluid from the fluid reservoir to the inflatable member. 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. The release of the pump bulb <NUM> creates a suction force that pulls fluid from the fluid reservoir to the pump bulb <NUM> as shown by the arrow in <FIG>. For example, the fluid flows through the fluid reservoir port <NUM> and through the valve body <NUM> and into the pump bulb <NUM>. In the valve body <NUM>, the fluid flows through a fluid passageway that includes the post area <NUM> and the refill valve <NUM>. The refill valve <NUM> being in-line with the fluid reservoir port <NUM> may minimize fluid pathway tortuosity, and may decrease the pressure drop across the refill valve <NUM> to increase refill time. The fluid does not enter the main bore <NUM> when being transferred through the fluid passageway from the fluid reservoir port <NUM> to the pump bulb <NUM>.

The depression (or squeezing) of the pump bulb <NUM> expels the fluid from the pump bulb <NUM> to the inflatable member. For example, in the valve body <NUM>, the fluid flows through the inflation valve <NUM>, into the main bore <NUM> (with the movable valve element <NUM> in the inflation position), and then out of the main bore <NUM> into the first and second cylinder fluid ports <NUM>, <NUM>. In the inflation position, the movable valve element <NUM> blocks a fluid passageway from the main bore <NUM> to the post area <NUM> (e.g., preventing fluid from flowing from the main bore <NUM> to the post area <NUM> during the inflation mode). Rather, the fluid flows through the main bore <NUM> between the ring member <NUM> and the end of the cavity of the main bore <NUM>, and into the first and second cylinder fluid ports <NUM>, <NUM>. In some examples, the fluid pathway from the pump bulb <NUM> to the first and second cylinder fluid ports <NUM>, <NUM> may decrease the pressure drop across the inflation valve <NUM> to allow for faster inflate time and may provide less fluid resistance (thereby requiring less pump bulb squeeze force).

The user may press the movable valve element <NUM> to move along the axis <NUM> to the deflation position (as shown in <FIG>, <FIG>). In some examples, the axis <NUM> is substantially orthogonal (e.g., perpendicular) to the axis <NUM>. In some examples, a single instantaneous push of the movable valve element <NUM> causes the movable valve element <NUM> to move to the deflation position (and stay in the deflation position). In the deflation position, the edge of the second end portion <NUM> of the movable valve element <NUM> may be disposed adjacent to (or contact) a protrusion at the end of the main bore <NUM> with the biasing member <NUM> being in a compressed state. In some examples, due to the pressure inside of the inflatable member, some of the fluid may be automatically transferred from the inflation member to the fluid reservoir via the pump assembly <NUM> (bypassing the pump bulb <NUM>), and then the user may squeeze the inflatable member to transfer some of the remaining fluid in the inflatable member.

Movement of the movable valve element <NUM> to the deflation position causes a fluid passageway to open between the main bore <NUM> and the post area <NUM> (as shown in <FIG>), and closes a fluid passageway from the main bore <NUM> to the inflation valve <NUM>. The fluid may flow from the first and second cylinder ports <NUM>, <NUM> into the main bore <NUM> (via a fluid passageway between the cylinder fluid ports <NUM>, <NUM> and the main bore <NUM>), and the movable valve element <NUM> causes the fluid to flow into the post area <NUM>. The fluid flows through the anti-auto inflate valve <NUM> and into the fluid reservoir port <NUM> (via a fluid passageway between the post area <NUM> and the fluid reservoir port <NUM>). In the deflation mode, the fluid is not routed through the pump bulb <NUM>. Also, in the deflation mode, the refill valve <NUM> and the inflation valve <NUM> are not used.

<FIG> illustrate various perspectives of a pump assembly <NUM> having a push 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 the inflation position, the pump assembly <NUM> transfers fluid from the fluid reservoir to the inflatable member via the pump bulb <NUM>. However, in the deflation position, the pump assembly <NUM> transfers fluid from the inflatable member to the fluid reservoir that bypasses the pump bulb <NUM>. In some examples, the push valve <NUM> is a push rod valve. In some examples, the pump assembly <NUM> is an example of the pump assembly <NUM> of <FIG>, and may include any of the features discussed with reference to the inflatable penile prosthesis <NUM> of <FIG> and/or the pump assembly <NUM> of <FIG>. Also, the pump assembly <NUM> of <FIG> and/or the pump assembly <NUM> of <FIG> may include any of the features with respect to the pump assembly <NUM> of <FIG> though 3E.

<FIG> illustrates a perspective of an exterior of the pump assembly <NUM> according to an aspect. <FIG> illustrates a perspective of the pump assembly <NUM> with the push valve <NUM> in the inflation position according to an aspect. <FIG> illustrates a perspective of the pump assembly <NUM> with the push valve <NUM> in the deflation position according to an aspect. <FIG> illustrates a perspective of a valve body <NUM> of the pump assembly <NUM> with the push valve <NUM> in the inflation position according to an aspect. <FIG> illustrates a perspective of the valve body <NUM> with the push valve <NUM> in the deflation position according to an aspect.

The pump assembly <NUM> includes the pump bulb <NUM>, the valve body <NUM>, the push valve <NUM>, a button component <NUM>, and fluid transfer ports such as a first cylinder fluid port <NUM>, a second cylinder fluid port <NUM>, and a fluid reservoir port <NUM>. The valve body <NUM> includes passageways and valve components. The valve body <NUM> and/or the pump assembly <NUM> include the push valve <NUM>, a refill valve <NUM>, and an inflation valve <NUM>. In some examples, the valve body <NUM> includes an anti-auto inflate area <NUM> (see <FIG>) that includes an anti-auto inflate valve. In some examples, the anti-auto inflate valve includes a check ball. In some examples, the anti-auto inflate valve includes a check ball and a biasing member (e.g., a spring).

The push valve <NUM> includes a movable valve element <NUM> and a biasing member <NUM> that biases the movable valve element <NUM> to the inflation position (as shown in <FIG>). As shown in <FIG> and <FIG>, the button component <NUM> may be a flexible button-shaped material that extends over the movable valve element <NUM>. In some examples, the button component <NUM> may be considered a portion of the valve body's housing extends from a side surface <NUM> of the valve body <NUM>. In some examples, the biasing member <NUM> includes an elastomer control valve spring. In some examples, the biasing member <NUM> includes a spring. In some examples, the movable valve element <NUM> includes an elongated cylindrical valve member. In some examples, the movable valve element <NUM> is a push rod having sections of different sizes. In some examples, the movable valve element <NUM> includes a poppet. In some examples, the movable valve element <NUM> includes a directional control valve.

As shown in greater detail in <FIG> and <FIG>, the movable valve element <NUM> includes a first end portion <NUM>, a first central portion <NUM>, a second central portion <NUM>, and a second end portion <NUM>. In some examples, the first end portion <NUM> includes a button-shaped end that is slightly smaller than the button component <NUM> such that the first end portion <NUM> can fit into the button component <NUM>. The second end portion <NUM> defines a ring member <NUM>. The ring member <NUM> may be a circular portion that extends around the end of the movable valve element <NUM>. In some examples, the ring member <NUM> includes an annular ring. In some examples, the ring member <NUM> includes a retainer ring. The second central portion <NUM> has a size (e.g., diameter) that is less than a size (e.g., diameter) of the first central portion <NUM>. In some examples, the first end portion <NUM> has a size (e.g., diameter) that is less than the size of the second central portion <NUM>. In some examples, the second central portion <NUM> has a length (e.g., extending along an axis <NUM>) longer than a length (e.g., extending along the axis <NUM>) of the first central portion <NUM>. In some examples, the push valve <NUM> (or the valve body <NUM> in general) includes a single poppet.

The movable valve element <NUM> (or a portion thereof) is movable within a main bore <NUM> defined by the valve body <NUM>. For example, in the inflation position, the first end portion <NUM> of the movable valve element <NUM> extends from the side surface <NUM> (but is covered by the button component <NUM>). In some examples, the main bore <NUM> is a cylindrical cavity. The user may press the movable valve element <NUM> to move the movable valve element <NUM> in the main bore <NUM> along the axis <NUM> to the deflation position (as shown in <FIG> and <FIG>). In some examples, the button component <NUM> then flexes back to its original shape while the movable valve element <NUM> remains in the deflation position. In the deflation position, the ring member <NUM> on the second end portion <NUM> of the movable valve element <NUM> may be disposed adjacent to the end of the main bore <NUM> and/or in contact with a portion <NUM> of the valve body <NUM> that slightly extends into the main bore <NUM>. In the deflation position, the biasing member <NUM> is compressed. In some examples, in the deflation position, the edge of the first end portion <NUM> of the movable valve element <NUM> may be disposed within the valve body <NUM> and/or substantially aligned with the side surface <NUM> of the valve body <NUM>.

The pressure in the inflatable member may hold the movable valve element <NUM> in the deflation position (e.g. cylinder pressure seats the push valve <NUM>). In some examples, the main bore <NUM> may include one or more protrusions that contact the ring member <NUM> (and/or another portion of the movable valve element <NUM>) to hold the movable valve element <NUM> in the deflation position. In some examples, the biasing member <NUM> is configured to return the movable valve element <NUM> to the inflation position in response to the cylinder pressure dropping below a threshold level. In some examples, the user may squeeze the pump bulb <NUM> and the resulting pressure causes the movable valve element <NUM> to move back to the inflation position.

The refill valve <NUM> is disposed in a fluid passageway between the main bore <NUM> and the pump bulb <NUM>. The refill valve <NUM> is used to transfer fluid in the inflation mode, but not used to transfer fluid in the deflation mode. In some examples, the refill valve <NUM> is a one-way valve. The refill valve <NUM> may include a floating check ball. In some examples, the refill valve <NUM> includes a floating check ball with fluting to increase and/or maximize fluid velocity across valve. In some examples, the refill valve <NUM> is aligned with the fluid reservoir port <NUM>. The fluid reservoir port <NUM> defines a longitudinal axis <NUM> and the refill valve <NUM> is aligned along the longitudinal axis <NUM>. For example, in the inflation mode, fluid flows through the refill valve <NUM> to the pump bulb <NUM>, and the refill valve <NUM> is positioned along an axis that is aligned with the longitudinal axis <NUM> of the fluid reservoir port <NUM>. The refill valve <NUM> being in-line with the fluid reservoir port <NUM> may minimize fluid pathway tortuosity, and may decrease the pressure drop across the refill valve <NUM> to increase refill time.

The inflation valve <NUM> is disposed within a fluid passageway between the main bore <NUM> and the pump bulb <NUM>. In some examples, the inflation valve <NUM> is disposed in a separate fluid passageway than the refill valve <NUM>. In some examples, the inflation valve <NUM> and the refill valve <NUM> are parallel to each other. The inflation valve <NUM> is used to transfer fluid during the inflation mode, but not used to transfer fluid in 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 that biases the inflation valve <NUM> to a sealing position. In some examples, the biasing member of the inflation valve <NUM> is a spring. In some examples, the size of the check ball of the inflation valve <NUM> is smaller than the size of the check ball of the refill valve <NUM>. In some examples, the smaller check ball and relatively light spring of the inflation valve <NUM> may decrease the squeeze force required to overcome the spring load.

In the inflation position (as shown in <FIG> and <FIG>), the pump bulb <NUM> is used to transfer fluid from the fluid reservoir to the inflatable member. 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. The release of the pump bulb <NUM> creates a suction force that pulls fluid from the fluid reservoir to the pump bulb <NUM> as shown by the arrow in <FIG>. For example, the fluid flows through the fluid reservoir port <NUM>, through the valve body <NUM>, through the refill valve <NUM>, and into the pump bulb <NUM>. In the valve body <NUM>, the fluid flows from the fluid reservoir port <NUM> into a portion <NUM> of the main bore <NUM>. In the inflation position, the portion <NUM> of the main bore <NUM> is a bore portion between the first central portion <NUM> of the movable valve element <NUM> and the ring member <NUM> of the movable valve element <NUM>. In the inflation position, the second central portion <NUM> (e.g., having the reduced size) of the movable valve element <NUM> is positioned in the main bore <NUM> such that the movable valve element <NUM> directs the flow of fluid around the second central portion <NUM> and into the fluid passageway having the refill valve <NUM>.

The depression (or squeezing) of the pump bulb <NUM> expels the fluid from the pump bulb <NUM> to the inflatable member. For example, the fluid flows from the pump bulb <NUM>, through the inflation valve <NUM>, into a portion <NUM> of the main bore <NUM>, and then into the first and second cylinder fluid ports <NUM>, <NUM>. In the inflation position, the portion <NUM> of the main bore <NUM> is a bore portion disposed between the ring member <NUM> of the movable valve element <NUM> and an end <NUM> of the main bore <NUM>. For instance, in the inflation position, the ring member <NUM> may separate the fluid passageway in the main bore <NUM> from the fluid reservoir port <NUM> to the pump bulb <NUM> and the fluid passageway in the main bore <NUM> from the pump bulb <NUM> to the first and second cylinder fluid ports <NUM>, <NUM>. In some examples, the fluid pathway from the pump bulb <NUM> to the first and second cylinder fluid ports <NUM>, <NUM> may decrease the pressure drop across the inflation valve <NUM> to allow for faster inflate time and may provide less fluid resistance (thereby requiring less pump bulb squeeze force).

The user may press the movable valve element <NUM> to move along the axis <NUM> to the deflation position (as shown in <FIG> and <FIG>). In some examples, the axis <NUM> is substantially orthogonal (e.g., perpendicular) to the axis <NUM>. In some examples, a single instantaneous push of the movable valve element <NUM> causes the movable valve element <NUM> to move to the deflation position (and stay in the deflation position). In the deflation position, the biasing member <NUM> is compressed, and the ring member <NUM> contacts a portion <NUM> of the valve body <NUM> that extends into the main bore <NUM>. In some examples, due to the pressure inside of the inflatable member, some of the fluid may be automatically transferred from the inflation member to the fluid reservoir via the pump assembly <NUM> (bypassing the pump bulb <NUM>), and then the user may squeeze the inflatable member to transfer some of the remaining fluid in the inflatable member.

Movement of the movable valve element <NUM> to the deflation position closes the fluid passageway in the main bore <NUM> between the fluid reservoir port <NUM> and the pump bulb <NUM> and closes the fluid passageway in the valve body <NUM> between the pump bulb <NUM> and the first and second cylinder ports <NUM>, <NUM>. As shown in <FIG>, in the deflation position, the fluid may flow through a portion of the main bore <NUM> between the ring member <NUM> and the first central portion <NUM>. In the deflation mode, the fluid is not routed through the pump bulb <NUM>. Also, in the deflation mode, the refill valve <NUM> and the inflation valve <NUM> are not used.

<FIG> illustrates a push valve <NUM> according to an aspect. The push valve <NUM> may be an example of any of the push valves discussed with reference to the previous figures, and may include any of the features discussed herein. <FIG> illustrates a perspective of the push valve <NUM> according to an aspect. <FIG> illustrates a perspective of the push valve <NUM> in the inflation position according to an aspect. <FIG> illustrates a perspective of the push valve <NUM> in the deflation position according to an aspect.

The push valve <NUM> includes a two-piece movable valve element <NUM>. The movable valve element <NUM> includes a first movable member <NUM> and a second movable member <NUM>. The first movable member <NUM> and the second movable member <NUM> are unitary bodies that are separate from each other. The first movable member <NUM> and the second movable member <NUM> are concentrically aligned. The first movable member <NUM> and the second movable member <NUM> are configured to move independently of each other within a main bore <NUM> of a valve body <NUM>. The push valve <NUM> includes a first biasing member <NUM> that biases the first movable member <NUM> to the inflation position, and a second biasing member <NUM> that biases the second movable member <NUM> to the inflation position. The first biasing member <NUM> and the second biasing member <NUM> are configured to be compressed upon an application of force. In some examples, the first biasing member <NUM> includes a spring having a plurality of coils. In some examples, the second biasing member <NUM> includes a spring having a plurality of coils.

The first movable member <NUM> may be a cylindrical body having sections with different sizes (e.g., diameters). The second movable member <NUM> may be a cylindrical body having sections with different sizes (e.g., diameters). The first movable member <NUM> includes a ring member <NUM> disposed on one end portion of the first movable member <NUM> and an interfacing portion <NUM> disposed on the other end portion of the first movable member <NUM>. The second movable member <NUM> includes a ring member <NUM> disposed on one end portion of the second movable member <NUM>, an interfacing portion <NUM> disposed on the other end portion of the second movable member <NUM>, and a ring member <NUM> disposed on the second movable member <NUM> at a location between the interfacing portion <NUM> and the ring member <NUM>. The ring members <NUM>, <NUM>, <NUM> may be circular portions that extend around portions of the first movable member <NUM> or the second movable member <NUM>. In some examples, the ring members <NUM>, <NUM>, <NUM> may be annular rings or retainer rings.

The interfacing portion <NUM> of the first movable member <NUM> may be movably coupled (e.g., contact and slide) with respect to the interfacing portion <NUM> of the second movable member <NUM>. In some examples, the interfacing portion <NUM> may overlap with the interfacing portion <NUM> and may move away from each other such that the interfacing portion <NUM> and the interfacing portion <NUM> partially overlap (or do not overlap at all). In some examples, each of the interfacing portion <NUM> and the interfacing portion <NUM> has a width that is narrower than other portions of the first movable member <NUM> and the second movable member <NUM>, respectively. In some examples, the first movable member <NUM> defines a channel or groove on a surface portion of the first movable member <NUM> that is configured to receive the interfacing portion <NUM> of the second movable member <NUM>, and the second movable member <NUM> defines a channel or groove on a surface portion of the second movable member <NUM> that is configured to receive the interfacing portion <NUM> of the first movable member <NUM>.

A user may press the button component <NUM> that causes the first movable member <NUM> and the second movable member <NUM> to linearly move to the deflation position in which the first biasing member <NUM> and the second biasing member <NUM> are compressed. The first biasing member <NUM> is disposed in the main bore <NUM>, and contacts the ring member <NUM> on the first movable member <NUM>. For example, the first biasing member <NUM> may be disposed between the ring member <NUM> and an end portion <NUM> of the main bore <NUM>. The ring member <NUM> defines slots <NUM> that receive coil portions of the first biasing member <NUM>. For example, the first biasing member <NUM> contacts the ring member <NUM> at the slots <NUM> to bias the first movable member <NUM> to the inflation position. The second biasing member <NUM> is disposed in the main bore <NUM>, and contacts the ring member <NUM> on the second movable member <NUM>. For example, the second biasing member <NUM> may be disposed between the ring member <NUM> and a portion <NUM> of the valve body <NUM> in the main bore <NUM>. The second biasing member <NUM> contacts the ring member <NUM> to bias the second movable member <NUM> to the inflation position. In some examples, the ring member <NUM> includes slots that receive coils portions of the second biasing member <NUM>.

<FIG> illustrate various perspectives of a pump assembly <NUM> having a push 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 push valve <NUM> is a switching valve pump. The pump assembly <NUM> may include any of the features discussed with reference to the inflatable penile prosthesis <NUM> of <FIG>, the pump assembly <NUM> of <FIG>, the pump assembly <NUM> of <FIG>, and/or the push valve <NUM> of <FIG>. Also, the pump assembly <NUM> of <FIG>, the pump assembly <NUM> of <FIG>, the pump assembly <NUM> of <FIG>, and/or the push valve <NUM> of <FIG> may include any of the features with respect to the pump assembly <NUM> of <FIG> though 3D.

<FIG> illustrates a perspective of an exterior of the pump assembly <NUM> with the push valve <NUM> in the deflation position according to an aspect. <FIG> illustrates a perspective of the pump assembly <NUM> with the push valve <NUM> in the inflation position according to an aspect. <FIG> illustrates a perspective of the pump assembly <NUM> with the push valve <NUM> in the deflation position according to an aspect. <FIG> illustrates a perspective of a valve body <NUM> of the pump assembly <NUM> with the push valve <NUM> in the deflation position according to an aspect.

The pump assembly <NUM> includes the pump bulb <NUM>, the valve body <NUM>, the push valve <NUM> movable with respect to the valve body <NUM>, and fluid transfer ports such as a first cylinder fluid port <NUM>, a second cylinder fluid port <NUM>, and a fluid reservoir port <NUM>. In some examples, the pump assembly <NUM> includes a button component that covers the push valve <NUM>. The valve body <NUM> includes passageways and valve components. The valve body <NUM> includes the push valve <NUM>, a refill valve <NUM>, an inflation valve <NUM>, and an anti-auto inflate valve <NUM>.

The push valve <NUM> includes a movable valve element <NUM> and a biasing member (not shown) that biases the movable valve element <NUM> to the inflation position (as shown in <FIG>). The push valve <NUM> may include a valve guide <NUM>. In the inflation position, a portion of the movable valve element <NUM> extends from a side surface <NUM> of the valve body <NUM>. In some examples, the biasing member includes a spring. In some examples, the movable valve element <NUM> includes an elongated cylindrical valve member. In some examples, the movable valve element <NUM> is a push rod having sections of different sizes. In some examples, the movable valve element <NUM> includes a poppet. In some examples, the movable valve element <NUM> includes a directional control valve.

The movable valve element <NUM> includes a first end portion <NUM>, a central portion <NUM>, and a second end portion <NUM>. In some examples, the central portion <NUM> has a size (e.g., diameter) less than a size (e.g., diameter) of the first end portion <NUM> and a size (e.g., diameter) of the second end portion <NUM>. In some examples, the first end portion <NUM> includes a ring member. In some examples, the second end portion <NUM> includes a ring member. In some examples, the ring member includes an annular ring or a retainer ring. The central portion <NUM> has a length longer than a length of the first end portion <NUM> and longer than a length of the second end portion <NUM>.

In some examples, the pressure in the inflatable member may hold the movable valve element <NUM> in the deflation position (e.g. cylinder pressure seats the push valve <NUM>). In some examples, the main bore <NUM> may include one or more protrusions that contact one or more portions of the movable valve element <NUM> to hold the movable valve element <NUM> in the deflation position. In some examples, the user may squeeze the pump bulb <NUM> and the resulting pressure causes the movable valve element <NUM> to move back to the inflation position.

The refill valve <NUM> is disposed in a fluid passageway between the fluid reservoir port <NUM> and the pump bulb <NUM>. The refill operation does not pass through the main bore <NUM> so there may be less fluid resistance in the refill state. The refill valve <NUM> is used to transfer fluid in the inflation mode, but not used to transfer fluid in the deflation mode. In some examples, the refill valve <NUM> is a one-way valve. The refill valve <NUM> may include a floating check ball. In some examples, the refill valve <NUM> includes a floating check ball with fluting to increase and/or maximize fluid velocity across valve. In some examples, the refill valve <NUM> is aligned with the fluid reservoir port <NUM>. The fluid reservoir port <NUM> defines a longitudinal axis <NUM> and the refill valve <NUM> is aligned along the longitudinal axis <NUM>. For example, in the inflation mode, fluid flows through the refill valve <NUM> to the pump bulb <NUM>, and the refill valve <NUM> is positioned along an axis that is aligned with the longitudinal axis <NUM> of the fluid reservoir port <NUM>. The refill valve <NUM> being in-line with the fluid reservoir port <NUM> may minimize fluid pathway tortuosity, and may decrease the pressure drop across the refill valve <NUM> to increase refill time.

In the inflation position, the pump bulb <NUM> is used to transfer fluid from the fluid reservoir to the inflatable member. 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. The release of the pump bulb <NUM> creates a suction force that pulls fluid from the fluid reservoir to the pump bulb <NUM> as shown by the arrow in <FIG>. For example, the fluid flows through the fluid reservoir port <NUM>, the refill valve <NUM>, and into the pump bulb <NUM>.

The depression (or squeezing) of the pump bulb <NUM> expels the fluid from the pump bulb <NUM> to the inflatable member. For example, the fluid flows from the pump bulb <NUM>, through the inflation valve <NUM>, into a portion of the main bore <NUM>, and then into the first and second cylinder fluid ports <NUM>, <NUM>. The second end portion <NUM> of the movable valve element <NUM> directs the fluid into the first and second cylinder fluid ports <NUM>, <NUM>. In some examples, the fluid pathway from the pump bulb <NUM> to the first and second cylinder fluid ports <NUM>, <NUM> may decrease the pressure drop across the inflation valve <NUM> to allow for faster inflate time and may provide less fluid resistance (thereby requiring less pump bulb squeeze force).

The user may press the movable valve element <NUM> to move along the axis <NUM> to the deflation position. In some examples, the axis <NUM> is substantially orthogonal (e.g., perpendicular) to the axis <NUM>. In some examples, a single instantaneous push of the movable valve element <NUM> moves the movable valve element <NUM> to the deflation position (and stay in the deflation position). As shown in <FIG>, in the deflation position, the fluid may flow from the first and second cylinder fluid ports <NUM>, <NUM>, through the anti-auto inflate valve <NUM>, and into the fluid reservoir port <NUM>. In the deflation mode, the fluid is not routed through the pump bulb <NUM>. Also, in the deflation mode, the refill valve <NUM> and the inflation valve <NUM> are not used.

<FIG> illustrates various perspectives of a feedback component <NUM> configured to provide at least one of tactile or auditory feedback in response to moving a movable valve element <NUM> to the deflation position. The feedback component <NUM> is disposed between the movable valve element <NUM> and a button component <NUM>. The feedback component <NUM> may be used in any of the push assemblies discussed herein.

<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. <FIG> illustrates the feedback component <NUM> disposed on an end surface <NUM> of the movable valve element <NUM> according to an aspect. When the button component <NUM> is pressed, the button component <NUM> moves the movable valve element <NUM> in order to place the push valve in the deflation position. The movable valve element <NUM> and the button component <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 push valves discussed herein.

Operation <NUM> includes transferring, by a pump assembly <NUM>, fluid from a fluid reservoir <NUM> to an inflatable member <NUM>, including 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 push valve <NUM> having a movable valve element <NUM>. Operation <NUM> includes pushing the movable valve element <NUM> along an axis <NUM> to a deflation position to change a fluid passageway through a valve body <NUM> of the pump assembly <NUM>. Operation <NUM> includes transferring the fluid from the inflatable member <NUM> to the fluid reservoir <NUM> via the push valve <NUM> 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 (including the push valve) 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>; <NUM>) configured to transfer the fluid between the fluid reservoir (<NUM>) and the inflatable member (<NUM>), the pump assembly (<NUM>; <NUM>) including a pump bulb (<NUM>; <NUM>), a valve body (<NUM>; <NUM>), a push valve (<NUM>; <NUM>) movably coupled to the valve body (<NUM>; <NUM>), a first fluid port (<NUM>) configured to be fluidly coupled to the fluid reservoir (<NUM>), and a second fluid port (<NUM>) configured to be fluidly coupled to the inflatable member (<NUM>), the push valve (<NUM>) including a movable valve element (<NUM>; <NUM>) configured to move between an inflation position and a deflation position within a main bore (<NUM>) of the valve body (<NUM>; <NUM>),
the pump assembly (<NUM>; <NUM>) including an anti-auto inflate valve (<NUM>) disposed within a post area (<NUM>) of the valve body (<NUM>, <NUM>),
the movable valve element (<NUM>; <NUM>) in the inflation position defining a fluid passageway through the main bore (<NUM>) to transfer fluid from the pump bulb (<NUM>; <NUM>) to the second fluid port (<NUM>), the movable valve element (<NUM>; <NUM>), when moved to the deflation position, configured to change the fluid passageway through the main bore (<NUM>), to transfer fluid from the second fluid port (<NUM>) to the main bore (<NUM>), where the movable valve element (<NUM>; <NUM>) causes the fluid to flow into the post area (<NUM>), such that the fluid flows through the anti-auto inflate valve (<NUM>) and into the first fluid port (<NUM>), such that the pump bulb (<NUM>; <NUM>) is bypassed.