Expandable penis prosthesis and pump assembly and control method thereof

Abstract

An inflatable penis prosthesis includes a fluid reservoir, an inflatable member, and a pump assembly. The pump assembly includes a pump ball, a valve body, a push valve movably coupled to the valve body, a first fluid port, and a second fluid port. The push valve includes a movable valve element configured to move within the bore of the valve body between an expanded position and a deflated position. The movable valve element defines a fluid passage through the bore in the expanded position to transfer fluid from the pump ball to the second fluid port. The movable valve element, when moved to the deflated position, is configured to change a fluid passage through the bore to transfer fluid from the second fluid port to the first fluid port such that the pump ball is bypassed.

Description

[0001] This application is a divisional application of the invention application with the application date of November 19, 2019, application number 201980077585.8, and name “Pump assembly with push valve for penile prosthesis and inflatable penile prosthesis”. Technical Field

[0002] The present disclosure relates generally to body implants and, more particularly, to body implants such as penile prostheses that include a pump assembly having a push valve to switch to a deflated mode. Background Art

[0003] One treatment for male erectile dysfunction is to implant a penile prosthesis that mechanically erects the penis. Some existing penile prostheses include an expandable cylinder or member that can be expanded or deflated using a pump mechanism. The pump mechanism draws fluid from a fluid reservoir and then transfers the fluid to the expandable member. The pump mechanism may include a pump ball and a valve body that includes one or more valve components. According to some existing designs of expandable penile prostheses, the complexity of the valve components may cause the pump ball to get stuck in the deflated state, in which case the user may have to deform the valve block to displace one or more valve components until the fluid can bypass them to refill the pump ball. Summary of the invention

[0004] According to one aspect, an inflatable penile prosthesis includes a fluid reservoir configured to contain a fluid, an inflatable member, and a pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member. The pump assembly includes a pump ball, 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 inflated position and a deflated position within a bore of the valve body. The movable valve element defines a fluid passage through the bore in the inflated position to transfer fluid from the pump ball to the second fluid port. The movable valve element is configured to change the fluid passage through the bore when moved to the deflated position to transfer fluid from the second fluid port to the first fluid port so that the pump ball is bypassed.

[0005] According to some aspects, 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 inflated position. The push valve may include a poppet valve having a ring member. The movable valve element is configured to move in a linear direction to the deflated position based on a single instantaneous push of the movable valve element by a user. The pump assembly may include a button component that surrounds a portion of the movable valve element when the movable valve element is in the inflated position. The pump assembly may include a feedback component disposed between the button component and the movable valve element, wherein the feedback component is configured to provide at least one of tactile or audible feedback in response to the movable valve element being moved to the deflated position. When the movable valve element is in the inflated position, a portion of the movable valve element may extend outside the valve body, and when the movable valve element is in the deflated position, the portion of the movable valve element may be disposed within the valve body. 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 ball when the movable valve element is in the inflated position. The valve body may include an expansion valve disposed in a fluid path between the pump ball and the bore. The movable valve element may include a first movable member and a second movable member, wherein the first movable member and the second movable member are configured to move independently relative to each other. The valve body may include a refill valve and an expansion valve, wherein the refill valve and the expansion valve are not used when the movable valve element is in the deflated position.

[0006] According to one aspect, a pump assembly for an inflatable penile prosthesis includes: a push valve movably coupled to a valve body, wherein the push valve includes a movable valve element configured to move between an inflated position and a deflated 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 defines a fluid passage through the bore in the inflated position to transfer fluid from a pump ball to the second fluid port. The movable valve element, when moved to the deflated position, is configured to change the fluid passage through the bore to transfer fluid from the second fluid port to the first fluid port such that the pump ball is bypassed.

[0007] According to some aspects, the pump assembly may include any one of the above / below features (or any combination thereof). The movable valve element may include a cylindrical one-piece body having at least two sections of 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 fluidically connected to a first cylindrical member of the expandable member, and the third tubular member is configured to be fluidically connected to a second cylindrical member of the expandable member. The pump assembly includes a refill valve disposed in the valve body at a position aligned with the longitudinal axis of the first fluid port, and an expansion valve disposed in the fluid passage between the bore and the pump ball. The movable valve element is configured to move from an expanded position to a deflated position along an axis, wherein the axis is substantially orthogonal to the longitudinal axis of the first fluid port. The pump assembly may include an anti-auto-expansion valve disposed in the fluid passage between the first fluid port and the second fluid port. When the movable valve element is in the expanded position, a portion of the movable valve element may extend outside the valve body, and the pump assembly may further include a button component surrounding 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 audible feedback in response to the movable valve element being moved to the deflated position.

[0008] According to one aspect, a method for controlling the direction of fluid through a pump assembly of an inflatable penile prosthesis includes transferring fluid from a fluid reservoir to an inflatable member through the pump assembly, including transferring fluid from the fluid reservoir to a pump ball via a refill valve, and transferring fluid from the pump ball 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 deflated position to change a fluid path through a valve body of the pump assembly, and transferring fluid from the inflatable member to the fluid reservoir via the push valve so that the fluid is not transferred through the pump ball. In some examples, when the movable valve element is in the deflated position, the refill valve and the inflation valve are not used to transfer fluid from the inflation member to the fluid reservoir. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 An inflatable penile prosthesis having a pump assembly with a push valve is shown according to one aspect.

[0010] Figure 2A The exterior of a pump assembly according to one aspect is shown.

[0011] Figure 2B A perspective view of a pump assembly according to one aspect is shown with a push valve in an expanded position.

[0012] Figure 2CA perspective view of a pump assembly according to one aspect is shown with a push valve in a deflated position.

[0013] Figure 2D A cross-section of a valve body of a pump assembly according to one aspect is shown with the push valve in a deflated position.

[0014] Figure 2E A view of a valve body of a pump assembly according to one aspect is shown with the push valve in a deflated position.

[0015] Figure 3A A perspective view of the exterior of a pump assembly according to one aspect is shown.

[0016] Figure 3B A perspective view of a pump assembly according to one aspect is shown with a push valve in an expanded position.

[0017] Figure 3C A perspective view of a pump assembly according to one aspect is shown with a push valve in a deflated position.

[0018] Figure 3D A perspective view of a valve body of a pump assembly according to one aspect is shown with the push valve in an expanded position.

[0019] Figure 3E A perspective view of a valve body according to one aspect is shown with the push valve in a deflated position.

[0020] Figure 4A A perspective view of a push valve according to one aspect is shown.

[0021] Figure 4B A perspective view of a push valve in an expanded position is shown according to one aspect.

[0022] Figure 4C A perspective view of a push valve in a deflated position is shown according to one aspect.

[0023] Figure 5A A perspective view of the exterior of a pump assembly according to one aspect is shown with a push valve in a deflated position.

[0024] Figure 5B A perspective view of a pump assembly according to one aspect is shown with a push valve in an expanded position.

[0025] Figure 5C A perspective view of a pump assembly according to one aspect is shown with a push valve in a deflated position.

[0026] Figure 5D A perspective view of a valve body of a pump assembly according to one aspect is shown with a push valve in a deflated position.

[0027] Fig. 6A A feedback component is shown as a dome structure according to one aspect.

[0028] Figure 6B A feedback component disposed on an end surface of a movable valve element is shown according to one aspect.

[0029] Figure 7 A flow chart is shown describing example operations of a method of controlling the direction of fluid through a pump assembly of an inflatable penile prosthesis according to one aspect.

[0030] Figure 8 An inflatable penile prosthesis having a pump assembly according to one aspect is schematically illustrated. DETAILED DESCRIPTION

[0031] Detailed embodiments are disclosed herein. However, it should be understood that the disclosed embodiments are merely examples, which can be implemented in various forms. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limiting, but only as the basis for the claims, and as a representative basis for teaching those skilled in the art to adopt the embodiments differently with substantially any appropriate detailed structure. In addition, the terms and phrases used herein are not intended to be limiting, but to provide an understandable description of the present disclosure.

[0032] As used herein, the terms "a" or "an" 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 "comprising" and / or "having" as used herein are defined as comprising (i.e., open ended). The terms "coupled" or "removably coupled" as used herein are defined as connected, but not necessarily directly and mechanically.

[0033] In general, embodiments relate to body implants. The term "patient" or "user" may be used hereinafter to refer to a person who benefits from a medical device or method disclosed in the present disclosure. For example, a patient may be a person whose body is implanted with a method or medical device disclosed in the present disclosure for operating a medical device.

[0034] Figure 1 An inflatable penile prosthesis 100 is shown according to one aspect and includes a fluid reservoir 102, an inflatable member 104, and a pump assembly 106 configured to transfer fluid between the fluid reservoir 102 and the inflatable member 104. The inflatable member 104 may be implanted in the corpora cavernosa of a user, the fluid reservoir 102 may be implanted in the user's abdominal or pelvic cavity (e.g., the fluid reservoir 102 may be implanted in a lower portion of the user's abdominal cavity or an upper portion of the user's pelvic cavity), and the pump assembly 106 may be implanted in the user's scrotum.

[0035] The pump assembly 106 includes a pump ball 108, a valve body 110, a push valve 124 movably coupled to the valve body 110, a first fluid port 114 fluidly coupled to the fluid reservoir 102 (via the first conduit connector 103), and a second fluid port 115 fluidly coupled to the expandable member 104 (via the second conduit connector 105). The first fluid port 114 and the second fluid port 115 may extend from an end portion of the valve body 110. In some examples, the fluid transfer port is disposed on (or defined by) a tube adapter (e.g., a three-tube adapter) that is separate from the valve body 110, and the tube adapter is coupled to the valve body 110. In some examples, the first fluid port 114 includes an elongated tubular member defining a cavity. In some examples, the second fluid port 115 includes two separate elongated tubular members (e.g., one tubular member fluidly coupled to a first cylindrical member of the expandable member 104, and the other tubular member fluidly coupled to a second cylindrical member of the expandable member 104).

[0036] The push valve 124 is configured to move from an expanded position to a deflated position along an axis 121 within the bore of the valve body 110 when pressed by a user so as to control the direction of the fluid passage of the fluid through the valve body 110. The push valve 124 includes a movable valve element 140 and a biasing member 144 that biases the movable valve element 140 to the expanded position. In some examples, the movable valve element 140 is configured to move in a linear direction to the deflated position based on a single momentary push of the movable valve element 140 by the user. The pump assembly 106 includes a button component 112 that surrounds a portion of the movable valve element 140 when the movable valve element 140 is in the expanded position. The button component 112 can be a flexible button-shaped material extending on the movable valve element 140.

[0037] In some examples, the movable valve element 140 includes a directional control valve. In some examples, the movable valve element 140 includes an elongated cylindrical body having at least two sections with different sizes. In some examples, the movable valve element 140 includes one or more ring members (e.g., an annular ring or a retainer ring). In some examples, the biasing member 144 includes a spring. In some examples, the movable valve element 140 includes a single integral body (e.g., a single cylindrical member). In some examples, the movable valve element 140 includes a two-piece member (e.g., a first movable member and a second movable member that are concentrically aligned and move independently of each other).

[0038] The design of the push valve 124 can reduce (or eliminate) the possibility of the pump ball 108 getting stuck in the deflated state even if the first squeeze to switch from the deflated mode to the inflated mode does not successfully move the movable valve element 140 to the inflated position. When the movable valve element 140 is in the inflated position, the inflatable penile prosthesis 100 is in the inflated mode (or inflated cycle). When the movable valve element 140 is in the deflated position, the inflatable penile prosthesis 100 is in the deflated mode (or deflated cycle). In some examples, a single momentary push of the movable valve element 140 switches the inflatable penile prosthesis 100 to the deflated position (rather than, for example, pressing and holding the movable valve element 140 for a predetermined time). In some examples, the movement of the movable valve element 140 to the deflated position causes the fluid passage between the second fluid port 115 and the first fluid port 114 to open, so that fluid can be transferred from the inflatable member 104 to the fluid reservoir 102 via the pump assembly 106 in a manner that bypasses the pump ball 108.

[0039] In contrast, in the inflation mode, the pump ball 108 is used to transfer fluid from the fluid reservoir 102 to the expandable member 104. For example, a user may depress (or squeeze) the pump ball 108 and then release the pump ball 108, and then repeat these operations until a desired stiffness is achieved in the expandable member 104. The release of the pump ball 108 creates a suction force that pulls fluid from the fluid reservoir 102 to the pump ball 108, and the depression of the pump ball 108 expels fluid from the pump ball 108 to the expandable member 104. In some examples, in the inflation mode, the valve body 110 provides an optimized fluid pathway via the push valve 124, which may reduce the pressure drop across the push valve 124 to obtain a faster inflation time and / or reduce fluid resistance, thereby requiring less pump ball squeezing force to inflate.

[0040] The pump ball 108 may be a flexible member defining a cavity. The pump ball 108 is coupled to the valve body 110 and extends from the valve body. In some examples, the pump ball 108 extends from the valve body 110 in a direction opposite to the direction in which the first fluid port 114 and the second fluid port 115 extend from the valve body 110 (e.g., located at opposite ends of the valve body 110). The pump ball 108 may be a squeeze pump. In some examples, the pump ball 108 includes ribs or dimples to help the user grip the pump ball 108. As described above, in the expansion mode, the pump ball 108 may use suction and pressure to move fluid into and out of the cavity of the pump ball 108. For example, the user may press or squeeze the pump ball 108 to expel the fluid from the cavity, and when the flexible member returns to its original shape, the suction generated pushes the fluid into the cavity of the pump ball 108. In some examples, the pump ball 108 may have a certain ball rebound rate, which is designed to refill the pump ball 108 within a selected time frame.

[0041] The valve body 110 defines one or more fluid passages passing through the valve body 110. The valve body 110 includes a valve member, which is arranged in the fluid passage to control the flow of fluid through the valve body 110 in the expansion mode and the deflation mode. In some examples, the valve body 110 includes a material block that defines the fluid passage and surrounds the valve member. In some examples, the valve body 110 includes a silicone material. In some examples, the valve body 110 can be molded from a silicone material with a medium hardness value. In some examples, the pump assembly 106 includes an outer protective shell disposed on the valve body 110. In some examples, the outer protective shell has a material different from the valve body 110 (e.g., a polymer material). In some examples, the outer protective shell includes one or more tactile features that help the user locate the valve body 110 (so as to locate the push valve 124). In some examples, the tactile features include protrusions, ridges, grooves, ridges, and / or depressions.

[0042] The valve body 110 includes a refill valve 120 and an expansion valve 122. In some examples, the valve body 110 includes an anti-automatic expansion valve. When the pump ball 108 is refilled, the refill valve 120 can be used. The refill valve 120 is not used in the deflated mode. In some examples, the refill valve 120 is a one-way valve. In some examples, the refill valve 120 is disposed in a fluid passage in the valve body 110 between the first fluid port 114 and the pump ball 108. In some examples, the fluid passage (which has the refill valve 120 extending between the first fluid port 114 and the pump ball 108) is only used to refill the pump ball 108 (e.g., a separate fluid passage), which can reduce the refill time of the ball (e.g., reduce the waiting time between squeezes). In some examples, the refill valve 120 is fluidly connected to the bore (where the valve 124 is pushed inward) and the pump ball 108.

[0043] In some examples, the refill valve 120 is aligned with the first fluid port 114. For example, the refill valve 120 can have an inlet and an outlet, wherein the fluid enters the inlet from the first fluid port 114 and exits the outlet to the pump ball 108. The first fluid port 114 can define a longitudinal axis 119 that extends along the fluid path of the refill valve 120 (e.g., between the inlet and the outlet). In some examples, the longitudinal axis 119 is orthogonal to the axis 121. The alignment of the refill valve 120 with the first fluid port 114 can minimize the tortuosity of the fluid path and / or reduce the pressure drop across the refill valve 120. In some examples, the refill valve 120 includes a floating check ball with a groove (which can increase or maximize the fluid velocity across the refill valve 120). In some examples, the refill valve 120 includes a biasing member that biases the refill valve 120 to a sealing position. In some examples, the biasing member includes a spring. In some examples, the refill valve 120 does not include a biasing member.

[0044] The expansion valve 122 can be disposed in the fluid passage between the pump ball 108 and the push valve 124. The expansion valve 122 can be used during the expansion of the expandable member 104 (e.g., when fluid is transferred from the pump ball 108 to the expandable member 104). During the deflated mode, the expansion valve 122 is not used. In some examples, the expansion valve 122 is a one-way valve. In some examples, the expansion valve 122 includes a check ball and a biasing member. The biasing member can bias the check ball to a sealing position. In some examples, the biasing member includes a spring.

[0045] In the expanded position (and when the user operates the pump ball 108), fluid can flow from the first fluid port 114 (from the fluid reservoir 102) to the pump ball 108 via the refill valve 120, and from the pump ball 108 to the second fluid port 115 (and then to the expandable member 104) via the expansion valve 122 and the push valve 124. In response to the movable valve element 140 being pressed to the deflated position, the position of the movable valve element 140 within the bore of the valve body 110 can open a fluid pathway in the valve body 110 to transfer fluid from the expandable member 104 to the fluid reservoir 102, which bypasses the pump ball 108. For example, when the movable valve element is moved to the deflated position, the movable valve element 140 is configured to change the fluid pathway through the bore to transfer fluid from the second fluid port 115 to the first fluid port 114, such that the pump ball 108 is bypassed. In some examples, due to the pressure within the expandable member 104 , some fluid may be automatically transferred from the expandable member 104 to the fluid reservoir 102 via the pump assembly 106 , and then the user may squeeze the expandable member 104 to transfer some of the remaining fluid in the expandable member 104 .

[0046] In some examples, the pump assembly 106 includes a feedback component disposed between the button component 112 and the movable valve element 140. The feedback component is configured to provide at least one of tactile or audible feedback in response to actuation of the movable valve element 140 being moved to the deflated position. For example, when the movable valve element 140 is pressed, the feedback component can provide an audible and / or tactile sensation that the inflatable penile prosthesis 100 has entered the deflated mode. In some examples, the feedback component includes a dome component.

[0047] Each of the first conduit connector 103 and the second conduit connector 105 can define a lumen configured to transfer fluid to and from the pump assembly 106. The first conduit connector 103 can be coupled to the pump assembly 106 and the fluid reservoir 102 such that the fluid can be transferred between the pump assembly 106 and the fluid reservoir 102 via the first conduit connector 103. For example, the first conduit connector 103 can define a first lumen configured to transfer fluid between the pump assembly 106 and the fluid reservoir 102. The first conduit connector 103 can include a single or multiple tubular members for transferring fluid between the pump assembly 106 and the fluid reservoir 102.

[0048] The second conduit connector 105 can be coupled to the pump assembly 106 and the expandable member 104 so that the fluid can be transmitted between the pump assembly 106 and the expandable member 104 via the second conduit connector 105. For example, the second conduit connector 105 can define a second lumen configured to transmit fluid between the pump assembly 106 and the expandable member 104. The second conduit connector 105 can include a single or multiple tubular members for transmitting fluid between the pump assembly 106 and the expandable member 104. In some examples, the first conduit connector 103 and the second conduit connector 105 can include a silicone rubber material. In some examples, the pump assembly 106 can be directly connected to the fluid reservoir 102.

[0049] The expandable member 104 can have the ability to expand when a fluid is injected into the cavity of the expandable member 104. For example, when the fluid is injected into the expandable member 104, the expandable member 104 can increase its length and / or width, as well as increase its stiffness. In some examples, the expandable member 104 can include a pair of expandable cylinders or at least two cylinders, such as a first cylinder member and a second cylinder member. The volume capacity of the expandable member 104 can depend on the size of the expandable cylinders. In some examples, the volume of fluid in each cylinder can vary from approximately 10 milliliters in a smaller cylinder to approximately 50 milliliters in a larger size. In some examples, the first cylinder member can be larger than the second cylinder member. In other examples, the first cylinder member can have the same size as the second cylinder member.

[0050] The fluid reservoir 102 can include a container having an interior chamber configured to hold or contain a fluid for inflating the inflatable member 104. The volume capacity of the fluid reservoir 102 can vary depending on the size of the inflatable penile prosthesis 100. In some examples, the volume capacity of the fluid reservoir 102 can be 3 to 150 cubic centimeters. In some examples, the fluid reservoir 102 is constructed of the same material as the inflatable member 104. In other examples, the fluid reservoir 102 is constructed of a different material than the inflatable member 104. In some examples, the fluid reservoir 102 contains a larger volume of fluid than the inflatable member 104.

[0051] Figures 2A to 2E Various perspective views of a pump assembly 206 are shown having a push valve 224 configured to move from an inflated position to a deflated position to open a fluid pathway that transfers fluid from the inflatable member to the fluid reservoir in a manner that bypasses the pump ball 208. For example, a user can push the push valve 224 to place the penile prosthesis in a deflated mode. In the inflated position, the pump assembly 206 transfers fluid from the fluid reservoir to the inflatable member via the pump ball 208. However, in the deflated position, the pump assembly 206 transfers fluid from the inflatable member to the fluid reservoir, which bypasses the pump ball 208. In some examples, the push valve 224 is a switching valve. In some examples, the pump assembly 206 is Figure 1 An example of a pump assembly 106 and may include reference Figure 1 Any of the features discussed above for the inflatable penile prosthesis 100. In addition, Figure 1 The pump assembly 106 may include Figures 2A to 2E Any features of pump assembly 206.

[0052] Figure 2A The exterior of a pump assembly 206 is shown according to one aspect. Figure 2B A perspective view of the pump assembly 206 is shown with the push valve 224 in an expanded position according to one aspect. Figure 2C A perspective view of the pump assembly 206 is shown with the push valve 224 in a deflated position according to one aspect. Figure 2D A cross-section of the valve body 210 of the pump assembly 206 is shown with the push valve 224 in a deflated position according to one aspect. Figure 2E A view of the valve body 210 of the pump assembly 206 is shown with the push valve 224 in a deflated position according to one aspect.

[0053] The pump assembly 206 includes a pump ball 208, a valve body 210, a push valve 224, a button member 212, and fluid delivery ports, such as a first cylinder fluid port 213, a second cylinder fluid port 215, and a fluid reservoir port 214. The fluid reservoir port 214 is configured to connect to a Figure 1 The first conduit connector 103, and the first column fluid port 213 and the second column fluid port 215 are configured to connect to Figure 1 The second conduit connector 105 of the embodiment of the present invention is provided. The first column fluid port 213 includes a first tubular member defining a cavity. The second column fluid port 215 includes a second tubular member defining a cavity. The fluid reservoir port 214 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 arranged parallel to each other.

[0054] In some examples, the pump assembly 206 includes a tube adapter 250. In some examples, the tube adapter 250 is a three-tube adapter. The tube adapter 250 can be a one-piece body (e.g., a single piece of material) that defines the first cylinder fluid port 213, the second cylinder fluid port 215, and the fluid reservoir port 214. For example, the tube adapter 250 can be manufactured separately from the valve body 210, but coupled together during assembly of the pump assembly 206. The tube adapter 250 is coupled to the valve body 210. In some examples, the tube adapter 250 is coupled to the valve body 210 using an interference fit. In some examples, the tube adapter 250 is coupled to the valve body 210 using an adhesive material and / or one or more fasteners.

[0055] The pump ball 208 may extend from the first end portion 216 of the valve body 210, and the fluid transfer port may extend from the second end portion 218 of the valve body 210. The valve body 210 includes a side surface 217 extending between the first end portion 216 and the second end portion 218 on one side of the valve body 210. The button member 212 may extend from the side surface 217 and cover the push valve 224. The user may press the button member 212 to move the push valve 224 to the deflated position. In some examples, a single momentary push of the push valve 224 causes the push valve 224 to move to the deflated position (and stay in the deflated position). For example, the user may not need to hold the push valve 224 for a predetermined period of time in order to move the push valve 224 to the deflated position.

[0056] The valve body 210 includes a passage and a valve member. The valve body 210 may include a silicone material. For example, the valve body 210 may be molded from a silicone material having a medium hardness value. The valve body 210 includes a push valve 224, a refill valve 220, an expansion valve 222, and an anti-automatic expansion valve 230. The anti-automatic expansion valve 230 is shown in FIG. Figure 2D Shown.

[0057] The push valve 224 includes a movable valve element 240 and a biasing member 244 (eg, Figure 2B210 ). The button component 212 may be a flexible button-shaped material extending over the movable valve element 240. In some examples, the button component 212 may be considered to be a portion of the housing of the valve body extending from the side surface 217 of the valve body 210. The biasing member 244 is biased to its extended length, and when the movable valve element 240 is pressed, the biasing member 244 is compressed to a shorter length (or compressed state). In some examples, the biasing member 244 includes a spring. In some examples, the movable valve element 240 includes an elongated cylindrical valve member. In some examples, the movable valve element 240 includes a poppet valve. In some examples, the movable valve element 240 includes a directional control valve. The movable valve element 240 includes a first end portion 243, a ring member 242, and a second end portion 245. The ring member 242 may be a circular portion extending around a portion of the axis of the movable valve element 240. In some examples, the ring member 242 includes an annular ring. In some examples, the ring member 242 includes a retainer ring. The ring member 242 is disposed on the movable valve element 240, at a position between the first end portion 243 and the second end portion 245. In some examples, the first end portion 243 includes a ring member. In some examples, the second end portion 245 includes a ring member. In some examples, the second end portion 245 has a certain size (e.g., diameter) that is smaller than the size (e.g., diameter) of the first end portion 243. In some examples, the first end portion 245 has a certain length (e.g., extending along the axis 221) that is longer than the length of the second end portion 245 (e.g., extending along the axis 221). In some examples, the push valve 224 (or generally the valve body 210) includes a directional control valve.

[0058] The movable valve element 240 (or a portion thereof) is movable within the main bore 225 defined by the valve body 210. For example, in the expanded position, the first end portion 243 of the movable valve element 240 extends from the side surface 217 (but is covered by the button member 212). In some examples, the main bore 225 is a cylindrical cavity. A user can press the movable valve element 240 in the main bore 225 along the axis 221 to the collapsed position (such as Figures 2C to 2E 225 ). In some examples, the button member 212 then bends back to its original shape while the movable valve element 240 is maintained in the deflated position. In the deflated position, the edge of the second end portion 245 of the movable valve element 240 can be disposed adjacent to (or in contact with) a protrusion extending from the end of the main bore 225, wherein the biasing member 244 is compressed. In some examples, in the deflated position, the first end portion 243 of the movable valve element 240 is disposed within the valve body 210 (or substantially aligned with the side surface 217 of the valve body 210).

[0059] The pressure in the inflatable member can hold the movable valve element 240 in the deflated position (e.g., the cylinder pressure causes the push valve 224 to be seated). In some examples, the main bore 225 can include one or more protrusions that contact the ring member 242 (and / or another portion of the movable valve element 240) to hold the movable valve element 240 in the deflated position (e.g., preventing the biasing member 244 from pushing the movable valve element 240 to the inflated position). To switch to the inflated mode, the user can squeeze the pump ball 208, and the resulting pressure causes the movable valve element 240 to move back to the inflated position. For example, if Figure 2E As shown, the portion of the main bore 225 disposed between the collar member 242 and the end of the main bore 225 defines an actuation force pressure region 247. When the user squeezes the pump ball 208, the pressure within the actuation force pressure region 247 increases, which forces the movable valve element 240 to switch to the expanded position.

[0060] The anti-auto-expansion valve 230 is disposed within a stem region 246 of the valve body 210. The stem region 246 can be considered a refill and anti-auto-expansion stem region. For example, the stem region 246 is a fluid passage region that transfers fluid from the fluid reservoir port 214 to refill the pump ball 208 (in the expansion mode) and also transfers fluid to the fluid reservoir port 214 (in the deflation mode). In some examples, the anti-auto-expansion valve 230 includes a check ball. In some examples, the anti-auto-expansion valve 230 includes a check ball and a biasing member (e.g., a spring).

[0061] The refill valve 220 is disposed in the fluid passage within the valve body 210, between the fluid reservoir port 214 and the pump ball 208. The refill valve 220 is used to transfer fluid in the expanded mode, but not to transfer fluid in the deflated mode. In some examples, the refill valve 220 is a one-way valve. The refill valve 220 may include a floating check ball. In some examples, the refill valve 220 includes a floating check ball with a groove to increase and / or maximize the fluid velocity through the valve. In some examples, the refill valve 220 is aligned with the fluid reservoir port 214. As shown in FIG. Figure 2BAs shown, the fluid reservoir port 214 defines a longitudinal axis 219, and the refill valve 220 is aligned along the longitudinal axis 219. For example, in the inflation mode, fluid flows through the refill valve 220 to the pump ball 208, and the refill valve 220 is positioned along an axis aligned with the longitudinal axis 219 of the fluid reservoir port 214. The refill valve 220 in line with the fluid reservoir port 214 can minimize the tortuosity of the fluid path, and can reduce the pressure drop across the refill valve 220 to increase the refill time. In some examples, the refill valve 220 and the anti-auto inflation valve 230 are disposed in the same fluid path within the valve body 210. In some examples, the refill valve 220 is aligned with the anti-auto inflation valve 230. For example, the longitudinal axis of the refill valve 220 can be substantially aligned with the longitudinal axis of the anti-auto inflation valve 230.

[0062] The expansion valve 222 is disposed within the fluid passageway within the valve body 210, between the main bore 225 and the pump ball 208. The expansion valve 222 is used to transfer fluid during the expansion mode, but is not used to transfer fluid in the deflated mode. In some examples, the expansion valve 222 is a one-way valve. In some examples, the expansion valve 222 includes a check ball and a biasing member that biases the expansion valve 222 to a sealed position. In some examples, the biasing member of the expansion valve 222 is a spring. In some examples, the size of the check ball of the expansion valve 222 is smaller than the size of the check ball of the refill valve 220. In some examples, the smaller check ball and relatively lighter spring of the expansion valve 222 can reduce the squeezing force required to overcome the spring load.

[0063] In the expanded position (such as Figure 2B ), the pump ball 208 is used to transfer fluid from the fluid reservoir to the expandable member. For example, the user can press (or squeeze) the pump ball 208 and then release the pump ball 208, and then repeat these operations until the desired stiffness is obtained in the expandable member. The release of the pump ball 208 generates a suction force, which draws fluid from the fluid reservoir to the pump ball 208, as shown. Figure 2B 24. As shown by the arrows in . For example, the fluid flows through the fluid reservoir port 214 and through the valve body 210, and into the pump ball 208. In the valve body 210, the fluid flows through the fluid passage, which includes the shank area 246 and the refill valve 220. The refill valve 220 in line with the fluid reservoir port 214 can minimize the tortuosity of the fluid passage and can reduce the pressure drop on the refill valve 220 to increase the refill time. When the fluid is transferred from the fluid reservoir port 214 to the pump ball 208 through the fluid passage, the fluid does not enter the main bore 225.

[0064] Depression (or squeezing) of the pump ball 208 discharges fluid from the pump ball 208 to the expandable member. For example, in the valve body 210, the fluid flows through the expansion valve 222, into the main bore 225 (where the movable valve element 240 is in the expanded position), and then out of the main bore 225 and into the first and second column fluid ports 213, 215. In the expanded position, the movable valve element 240 blocks the fluid passage from the main bore 225 to the stake area 246 (e.g., preventing fluid from flowing from the main bore 225 to the stake area 246 during the expansion mode). Instead, the fluid flows through the main bore 225 between the collar member 242 and the end of the cavity of the main bore 225, and into the first and second column fluid ports 213, 215. In some examples, the fluid pathway from the pump ball 208 to the first and second cylinder fluid ports 213 , 215 can reduce the pressure drop across the inflation valve 222 to allow for faster inflation times and can provide less fluid resistance (thereby requiring less pump ball squeezing force).

[0065] The user can press the movable valve element 240 to move along the axis 221 to the deflated position (eg, Figure 2C , 2D 2E). In some examples, axis 221 is substantially orthogonal (e.g., perpendicular) to axis 219. In some examples, a single momentary push of movable valve element 240 causes movable valve element 240 to move to (and remain in) a deflated position. In the deflated position, an edge of second end portion 245 of movable valve element 240 can be disposed adjacent to (or in contact with) a protrusion at the end of main bore 225, with biasing member 244 in a compressed state. In some examples, due to the pressure within the expandable member, some fluid can be automatically transferred from the expansion member to the fluid reservoir via pump assembly 206 (bypassing pump ball 208), and then the user can squeeze the expandable member to transfer some of the remaining fluid in the expandable member.

[0066] Movement of the movable valve element 240 to the deflated position results in the opening of a fluid passage between the main bore 225 and the shank region 246 (eg, Figure 2D 246). The pump ball 208 is in the deflated mode and the refill valve 220 and the inflation valve 222 are not used.

[0067] Figures 3A to 3E Various perspective views of a pump assembly 306 are shown, the pump assembly having a push valve 324 configured to move from an expanded position to a deflated position to open a fluid pathway that transfers fluid from the expandable member to the fluid reservoir in a manner that bypasses the pump ball 308. In the expanded position, the pump assembly 306 transfers fluid from the fluid reservoir to the expandable member via the pump ball 308. However, in the deflated position, the pump assembly 306 transfers fluid from the expandable member to the fluid reservoir, bypassing the pump ball 308. In some examples, the push valve 324 is a push rod valve. In some examples, the pump assembly 306 is Figure 1 An example of a pump assembly 106 and may include reference Figure 1 The inflatable penile prosthesis 100 and / or Figures 2A to 2E Any of the features discussed for the pump assembly 206. In addition, Figure 1 The pump assembly 106 and / or Figures 2A to 2E The pump assembly 206 may include Figures 3A to 3E Any features of pump assembly 306.

[0068] Figure 3A A perspective view of the exterior of a pump assembly 306 is shown according to one aspect. Figure 3B A perspective view of the pump assembly 306 is shown with the push valve 324 in an expanded position according to one aspect. Figure 3C A perspective view of the pump assembly 306 is shown with the push valve 324 in a deflated position according to one aspect. Figure 3D A perspective view of the valve body 310 of the pump assembly 306 is shown with the push valve 324 in an expanded position according to one aspect. Figure 3E A perspective view of the valve body 310 is shown with the push valve 324 in a deflated position according to one aspect.

[0069] The pump assembly 306 includes a pump ball 308, a valve body 310, a push valve 324, a button component 312, and fluid transfer ports, such as a first column fluid port 313, a second column fluid port 315, and a fluid reservoir port 314. The valve body 310 includes a passage and a valve component. The valve body 310 and / or the pump assembly 306 include a push valve 324, a refill valve 320, and an expansion valve 322. In some examples, the valve body 310 includes an anti-auto expansion area 365 (see Figure 3C ), which includes an anti-automatic expansion valve. In some examples, the anti-automatic expansion valve includes a check ball. In some examples, the anti-automatic expansion valve includes a check ball and a biasing member (e.g., a spring).

[0070] The push valve 324 includes a movable valve element 340 and a biasing member 344 (eg, a biasing member 344) that biases the movable valve element 340 to an expanded position. Figure 3BAs shown in Figure 3A and 3B As shown, the button component 312 can be a flexible button-shaped material extending on the movable valve element 340. In some examples, the button component 312 can be considered as a part of the housing of the valve body extending from the side surface 317 of the valve body 310. In some examples, the biasing member 344 includes an elastomeric control valve spring. In some examples, the biasing member 344 includes a spring. In some examples, the movable valve element 340 includes an elongated cylindrical valve member. In some examples, the movable valve element 340 is a push rod, which has sections of different sizes. In some examples, the movable valve element 340 includes a lift valve. In some examples, the movable valve element 340 includes a directional control valve.

[0071] like Figure 3D and 3E As shown in more detail in FIG. 3 , the movable valve element 340 includes a first end portion 343, a first center portion 347, a second center portion 349, and a second end portion 345. In some examples, the first end portion 343 includes a button-shaped end that is slightly smaller than the button component 312 so that the first end portion 343 can fit into the button component 312. The second end portion 345 defines a ring member 342. The ring member 342 can be a circular portion extending around the end of the movable valve element 340. In some examples, the ring member 342 includes an annular ring. In some examples, the ring member 342 includes a retainer ring. The second center portion 349 has a certain size (e.g., diameter) that is smaller than the size (e.g., diameter) of the first center portion 347. In some examples, the first end portion 343 has a certain size (e.g., diameter) that is smaller than the size of the second center portion 349. In some examples, second central portion 349 has a length (eg, extending along axis 321) that is longer than a length (eg, extending along axis 321) of first central portion 347. In some examples, push valve 324 (or valve body 310 generally) includes a single poppet valve.

[0072] The movable valve element 340 (or a portion thereof) is movable within the main bore 325 defined by the valve body 310. For example, in the expanded position, the first end portion 343 of the movable valve element 340 extends from the side surface 317 (but is covered by the button member 312). In some examples, the main bore 325 is a cylindrical cavity. A user can press the movable valve element 340 to move the movable valve element 340 in the main bore 325 along the axis 321 to the collapsed position (such as Figure 3C and 3D325 ). In some examples, the button member 312 is then bent back to its original shape while the movable valve element 340 is maintained in the deflated position. In the deflated position, the ring member 342 on the second end portion 345 of the movable valve element 340 can be disposed adjacent to the end of the main bore 325 and / or in contact with a portion 362 of the valve body 310 that extends slightly into the main bore 325. In the deflated position, the biasing member 344 is compressed. In some examples, in the deflated position, the edge of the first end portion 343 of the movable valve element 340 can be disposed within the valve body 310 and / or substantially aligned with the side surface 317 of the valve body 310.

[0073] The pressure in the inflatable member can hold the movable valve element 340 in the deflated position (e.g., the column pressure causes the push valve 324 to be seated). In some examples, the main bore 325 can include one or more protrusions that contact the ring member 342 (and / or another portion of the movable valve element 340) to hold the movable valve element 340 in the deflated position. In some examples, the biasing member 344 is configured to return the movable valve element 340 to the inflated position in response to the column pressure falling below a threshold level. In some examples, the user can squeeze the pump ball 308, and the resulting pressure causes the movable valve element 340 to move back to the inflated position.

[0074] The refill valve 320 is disposed in the fluid passage between the main bore 325 and the pump ball 308. The refill valve 320 is used to transfer fluid in the expansion mode, but not for transferring fluid in the deflated mode. In some examples, the refill valve 320 is a one-way valve. The refill valve 320 may include a floating check ball. In some examples, the refill valve 320 includes a floating check ball with a groove to increase and / or maximize the fluid velocity through the valve. In some examples, the refill valve 320 is aligned with the fluid reservoir port 314. The fluid reservoir port 314 defines a longitudinal axis 319, and the refill valve 320 is aligned along the longitudinal axis 319. For example, in the expansion mode, the fluid flows to the pump ball 308 through the refill valve 320, and the refill valve 320 is positioned along an axis aligned with the longitudinal axis 319 of the fluid reservoir port 314. A refill valve 320 that is in line with the fluid reservoir port 314 may minimize the tortuosity of the fluid pathway and may reduce the pressure drop across the refill valve 320 to increase refill time.

[0075] The expansion valve 322 is disposed in a fluid passage between the main bore 325 and the pump ball 308. In some examples, the expansion valve 322 is disposed in a fluid passage separate from the refill valve 320. In some examples, the expansion valve 322 and the refill valve 320 are parallel to each other. The expansion valve 322 is used to transfer fluid during the expansion mode, but is not used to transfer fluid in the deflation mode. In some examples, the expansion valve 322 is a one-way valve. In some examples, the expansion valve 322 includes a check ball and a biasing member that biases the expansion valve 322 to a sealed position. In some examples, the biasing member of the expansion valve 322 is a spring. In some examples, the size of the check ball of the expansion valve 322 is smaller than the size of the check ball of the refill valve 320. In some examples, the smaller check ball and relatively light spring of the expansion valve 322 can reduce the squeezing force required to overcome the spring load.

[0076] In the expanded position (such as Figure 3B and 3D ), the pump ball 308 is used to transfer fluid from the fluid reservoir to the expandable member. For example, the user can press (or squeeze) the pump ball 308 and then release the pump ball 308, and then repeat these operations until the desired stiffness is obtained in the expandable member. The release of the pump ball 308 generates a suction force, which draws fluid from the fluid reservoir to the pump ball 308, as shown. Figure 3B 314, through the valve body 310, through the refill valve 320, and into the pump ball 308. In the valve body 310, the fluid flows from the fluid reservoir port 314 into a portion 364 of the main bore 325. In the expanded position, the portion 364 of the main bore 325 is the portion of the bore between the first center portion 347 of the movable valve element 340 and the ring member 342 of the movable valve element 340. In the expanded position, the second center portion 349 of the movable valve element 340 (e.g., having a reduced size) is positioned in the main bore 325, so that the movable valve element 340 directs the fluid to flow around the second center portion 349 and into the fluid passage with the refill valve 320.

[0077] The depression (or squeezing) of the pump ball 308 discharges fluid from the pump ball 308 to the expandable member. For example, the fluid flows from the pump ball 308 through the expansion valve 322 into a portion 366 of the main bore 325 and then into the first and second column fluid ports 313, 315. In the expanded position, the portion 366 of the main bore 325 is the portion of the bore disposed between the collar member 342 of the movable valve element 340 and the end 368 of the main bore 325. For example, in the expanded position, the collar member 342 can separate a fluid path in the main bore 325 from the fluid reservoir port 314 to the pump ball 308 from a fluid path in the main bore 325 from the pump ball 308 to the first and second column fluid ports 313, 315. In some examples, the fluid pathway from the pump ball 308 to the first and second cylinder fluid ports 313 , 315 can reduce the pressure drop across the inflation valve 322 to allow for faster inflation times and can provide less fluid resistance (thereby requiring less pump ball squeezing force).

[0078] The user can press the movable valve element 340 to move along the axis 321 to the deflated position (eg, Figure 3C and 3E 321 is substantially orthogonal (e.g., perpendicular) to axis 319. In some examples, a single momentary push of movable valve element 340 causes movable valve element 340 to move to (and remain in) the deflated position. In the deflated position, biasing member 344 is compressed, and annular member 342 contacts portion 362 of valve body 310 that extends into main bore 325. In some examples, due to the pressure within the expandable member, some fluid can be automatically transferred from the expansion member to the fluid reservoir via pump assembly 306 (bypassing pump ball 308), and then the user can squeeze the expandable member to transfer some of the remaining fluid in the expandable member.

[0079] Movement of the movable valve element 340 to the deflated position closes the fluid path in the main bore 325 between the fluid reservoir port 314 and the pump ball 308, and closes the fluid path in the valve body 310 between the pump ball 308 and the first and second cylinder ports 313, 315. Figure 3C As shown, in the deflated position, fluid can flow through the portion of the main bore 325 between the collar member 342 and the first central portion 347. In the deflated mode, fluid does not pass through the pump ball 308. In addition, in the deflated mode, the refill valve 320 and the inflation valve 322 are not used.

[0080] Figures 4A to 4C A push valve 424 is shown according to one aspect. The push valve 424 can be an example of any of the push valves discussed with reference to the previous figures, and can include any of the features discussed herein. Figure 4AA perspective view of a push valve 424 is shown according to one aspect. Figure 4B A perspective view of the push valve 424 is shown in an expanded position according to one aspect. Figure 4C A perspective view of a push valve 424 is shown in a deflated position according to one aspect.

[0081] The push valve 424 includes a two-piece movable valve element 440. The movable valve element 440 includes a first movable member 470 and a second movable member 472. The first movable member 470 and the second movable member 472 are one-piece bodies separated from each other. The first movable member 470 and the second movable member 472 are concentrically aligned. The first movable member 470 and the second movable member 472 are configured to move independently of each other in the main bore 425 of the valve body 410. The push valve 424 includes a first biasing member 444 that biases the first movable member 470 to an expanded position, and a second biasing member 445 that biases the second movable member 472 to an expanded position. The first biasing member 444 and the second biasing member 445 are configured to be compressed when a force is applied. In some examples, the first biasing member 444 includes a spring having a plurality of coils. In some examples, the second biasing member 445 includes a spring having a plurality of coils.

[0082] The first movable member 470 can be a cylindrical body having sections of different sizes (e.g., diameters). The second movable member 472 can be a cylindrical body having sections of different sizes (e.g., diameters). The first movable member 470 includes a ring member 442 disposed on one end portion of the first movable member 470 and an engagement portion 471 disposed on the other end portion of the first movable member 470. The second movable member 472 includes a ring member 443 disposed on one end portion of the second movable member 472, an engagement portion 473 disposed on the other end portion of the second movable member 472, and a ring member 447 disposed on the second movable member 472 at a position between the engagement portion 473 and the ring member 443. The ring members 442, 443, 447 can be circular portions extending around a portion of the first movable member 470 or the second movable member 472. In some examples, the ring members 442, 443, 447 can be an annular ring or a retainer ring.

[0083] The engaging portion 471 of the first movable member 470 may be movably coupled (e.g., contacting and sliding) relative to the engaging portion 473 of the second movable member 472. In some examples, the engaging portion 471 may overlap with the engaging portion 473 and may be moved away from each other so that the engaging portion 471 and the engaging portion 473 partially overlap (or do not overlap at all). In some examples, each of the engaging portion 471 and the engaging portion 473 has a certain width that is narrower than other portions of the first movable member 470 and the second movable member 472, respectively. In some examples, the first movable member 470 defines a channel or groove configured to receive the engaging portion 473 of the second movable member 472 on a surface portion of the first movable member 470, and the second movable member 472 defines a channel or groove configured to receive the engaging portion 471 of the first movable member 470 on a surface portion of the second movable member 472.

[0084] The user can press the button component 412, which causes the first movable member 470 and the second movable member 472 to move linearly to the collapsed position, in which the first biasing member 444 and the second biasing member 445 are compressed. The first biasing member 444 is disposed in the main bore 425 and contacts the ring member 442 on the first movable member 470. For example, the first biasing member 444 can be disposed between the ring member 442 and the end portion 480 of the main bore 425. The ring member 442 defines a slot 474 that receives the coil portion of the first biasing member 444. For example, the first biasing member 444 contacts the ring member 442 at the slot 474 to bias the first movable member 470 to the expanded position. The second biasing member 445 is disposed in the main bore 425 and contacts the ring member 447 on the second movable member 472. For example, the second biasing member 445 can be disposed between a portion 482 of the valve body 410 in the main bore 425 and the ring member 447. The second biasing member 445 contacts the ring member 447 to bias the second movable member 472 to the expanded position. In some examples, the ring member 447 includes a slot that receives a coil portion of the second biasing member 445.

[0085] Figures 5A to 5D Various perspective views of a pump assembly 506 are shown having a push valve 524 configured to move from an expanded position to a deflated position to open a fluid passage that transfers fluid from the expandable member to the fluid reservoir in a manner that bypasses the pump ball 508. In some examples, the push valve 524 is a toggle valve pump. The pump assembly 506 may include reference Figure 1 The inflatable penis prosthesis 100, Figures 2A to 2E Pump assembly 206, Figures 3A to 3D The pump assembly 306 and / or Figures 4A to 4CAny of the features discussed above for the push valve 424. In addition, Figure 1 Pump assembly 106, Figures 2A to 2E Pump assembly 206, Figures 3A to 3D The pump assembly 306 and / or Figures 4A to 4C The push valve 424 may include Figures 5A to 3D Any features of pump assembly 506.

[0086] Figure 5A A perspective view of the exterior of the pump assembly 506 is shown with the push valve 524 in a deflated position according to one aspect. Figure 5B A perspective view of a pump assembly 506 is shown with the push valve 524 in an expanded position according to one aspect. Figure 5C A perspective view of a pump assembly 506 is shown with the push valve 524 in a deflated position according to one aspect. Figure 5D A perspective view of a valve body 510 of a pump assembly 506 is shown with a push valve 524 in a deflated position according to one aspect.

[0087] The pump assembly 506 includes a pump ball 508, a valve body 510, a push valve 524 movable relative to the valve body 510, and fluid transfer ports, such as a first column fluid port 513, a second column fluid port 515, and a fluid reservoir port 514. In some examples, the pump assembly 506 includes a button component covering the push valve 524. The valve body 510 includes a passage and a valve component. The valve body 510 includes a push valve 524, a refill valve 520, an expansion valve 522, and an anti-automatic expansion valve 530.

[0088] The push valve 524 includes a movable valve element 540 and a biasing member (not shown) that biases the movable valve element 540 to an expanded position (eg, Figure 5B 585 . In the expanded position, a portion of the movable valve element 540 extends from the side surface 517 of the valve body 510 . In some examples, the biasing member includes a spring. In some examples, the movable valve element 540 includes an elongated cylindrical valve member. In some examples, the movable valve element 540 is a push rod having sections of different sizes. In some examples, the movable valve element 540 includes a poppet valve. In some examples, the movable valve element 540 includes a directional control valve.

[0089] The movable valve element 540 includes a first end portion 543, a central portion 549, and a second end portion 545. In some examples, the central portion 549 has a certain size (e.g., diameter) that is smaller than the size (e.g., diameter) of the first end portion 543 and the size (e.g., diameter) of the second end portion 545. In some examples, the first end portion 543 includes a ring member. In some examples, the second end portion 545 includes a ring member. In some examples, the ring member includes an annular ring or a retainer ring. The central portion 549 has a certain length that is longer than the length of the first end portion 543 and longer than the length of the second end portion 545.

[0090] In one example, pressure in the inflatable member can hold the movable valve element 540 in the deflated position (e.g., the cylinder pressure pushes the valve 524 into position). In some examples, the main bore 525 can include one or more protrusions that contact one or more portions of the movable valve element 540 to hold the movable valve element 540 in the deflated position. In some examples, the user can squeeze the pump ball 508, and the resulting pressure causes the movable valve element 540 to move back to the inflated position.

[0091] The refill valve 520 is disposed in the fluid passage between the fluid reservoir port 514 and the pump ball 508. The refill operation does not pass through the main bore 525, so there can be less fluid resistance in the refill state. The refill valve 520 is used to transmit fluid in the expansion mode, but not for transmitting fluid in the deflated mode. In some examples, the refill valve 520 is a one-way valve. The refill valve 520 may include a floating check ball. In some examples, the refill valve 520 includes a floating check ball with a groove to increase and / or maximize the fluid velocity through the valve. In some examples, the refill valve 520 is aligned with the fluid reservoir port 514. The fluid reservoir port 514 defines a longitudinal axis 519, and the refill valve 520 is aligned along the longitudinal axis 519. For example, in the inflation mode, fluid flows through the refill valve 520 to the pump ball 508, and the refill valve 520 is positioned along an axis aligned with the longitudinal axis 519 of the fluid reservoir port 514. The refill valve 520 in line with the fluid reservoir port 514 can minimize the tortuosity of the fluid pathway and can reduce the pressure drop across the refill valve 520 to increase the refill time.

[0092] The expansion valve 522 is disposed in a fluid passage between the main bore 525 and the pump ball 508. In some examples, the expansion valve 522 is disposed in a fluid passage separate from the refill valve 520. In some examples, the expansion valve 522 and the refill valve 520 are parallel to each other. The expansion valve 522 is used to transfer fluid during the expansion mode, but not to transfer fluid in the deflation mode. In some examples, the expansion valve 522 is a one-way valve. In some examples, the expansion valve 522 includes a check ball and a biasing member that biases the expansion valve 522 to a sealed position. In some examples, the biasing member of the expansion valve 522 is a spring. In some examples, the size of the check ball of the expansion valve 522 is smaller than the size of the check ball of the refill valve 520. In some examples, the smaller check ball and relatively lighter spring of the expansion valve 522 can reduce the squeezing force required to overcome the spring load.

[0093] In the expanded position, the pump ball 508 is used to transfer fluid from the fluid reservoir to the expandable member. For example, the user can press (or squeeze) the pump ball 508 and then release the pump ball 508, and then repeat these operations until the desired stiffness is achieved in the expandable member. The release of the pump ball 508 generates a suction force that draws fluid from the fluid reservoir to the pump ball 308, such as Figure 5B For example, fluid flows through the fluid reservoir port 514, the refill valve 520, and into the pump ball 508.

[0094] The pressing (or squeezing) of the pump ball 508 discharges fluid from the pump ball 508 to the expandable member. For example, the fluid flows from the pump ball 508 through the expansion valve 522 into a portion of the main bore 525 and then into the first and second column fluid ports 513, 515. The second end portion 545 of the movable valve element 540 guides the fluid into the first and second column fluid ports 513, 515. In some examples, the fluid passage from the pump ball 508 to the first and second column fluid ports 513, 515 can reduce the pressure drop across the expansion valve 522 to allow for faster inflation time, and can provide less fluid resistance (thereby requiring less pump ball squeezing force).

[0095] The user can press the movable valve element 540 to move along the axis 521 to the deflated position. In some examples, the axis 521 is substantially orthogonal (e.g., perpendicular) to the axis 519. In some examples, a single momentary push of the movable valve element 540 moves the movable valve element 540 to the deflated position (and stays in the deflated position). Figure 5C As shown, in the deflated position, fluid can flow from the first and second cylinder fluid ports 513, 515 through the anti-autoinflation valve 530 and into the fluid reservoir port 514. In the deflated mode, fluid does not pass through the pump ball 508. Additionally, in the deflated mode, the refill valve 520 and inflation valve 522 are not used.

[0096] Figures 6A to 6B Various perspective views of a feedback component 611 are shown, the feedback component being configured to provide at least one of tactile or audible feedback in response to moving the movable valve element 640 to the deflated position. The feedback component 611 is disposed between the movable valve element 640 and the button component 612. The feedback component 611 can be used with any push assembly discussed herein.

[0097] Fig. 6A The feedback component 611 is shown as a dome structure 685 according to one aspect. In some examples, the dome structure 685 includes a circular arch and a circular base. In some examples, the dome structure 685 can produce a sound when the dome structure 685 is compressed. In some examples, the dome structure 685 can provide a tactile sensation that a user can perceive when the dome structure 685 is compressed. Figure 6B A feedback component 611 is shown disposed on an end surface 633 of a movable valve element 640 according to one aspect. When a button component 612 is pressed, the button component 612 moves the movable valve element 640 to place the push valve in a deflated position. The movable valve element 640 and the button component 612 compress the feedback component 611, which causes the feedback component 611 to provide at least one of tactile or audible feedback.

[0098] Figure 7 A flow chart 700 is shown that describes example operations of a method of controlling the direction of fluid through a pump assembly of an inflatable penile prosthesis according to one aspect. Figure 1 Flowchart 700 is illustrated with reference to the inflatable penile prosthesis 100 of FIG. 1 , but the exemplary operations of flowchart 700 may be performed by any inflatable penile prosthesis, pump assembly, and / or push valve discussed herein.

[0099] Operation 702 includes transferring fluid from the fluid reservoir 102 to the expandable member 104 through the pump assembly 106, which includes transferring fluid from the fluid reservoir 102 to the pump ball 108 via the refill valve 120, and transferring fluid from the pump ball 108 to the expandable member 104 via the inflation valve 122 and the push valve 124 having the movable valve element 140. Operation 704 includes pushing the movable valve element 140 to a deflated position along the axis 121 to change the fluid passage through the valve body 110 of the pump assembly 106. Operation 706 includes transferring fluid from the expandable member 104 to the fluid reservoir 102 via the push valve 124 so that the fluid is not transferred through the pump ball 108.

[0100] Figure 8Schematically illustrated is an inflatable penile prosthesis 800 having a pump assembly 806 according to one aspect. The pump assembly 806 can include any of the features of the pump assembly (including the push valve) described with reference to the previous figures. The penile prosthesis 800 can include a pair of inflatable cylinders 810, and the inflatable cylinders 810 are configured to be implanted in the penis. For example, one of the inflatable cylinders 810 can be disposed on one side of the penis, and the other inflatable cylinder 810 can be disposed on the other side of the penis. Each inflatable cylinder 810 can include a first end portion 824, a cavity or inflated chamber 822, and a second end portion 828 having a rear end 832.

[0101] The pump assembly 806 can be implanted in the patient's scrotum. A pair of catheter connectors 805 can attach the pump assembly 806 to the expandable cylinder 810 so that the pump assembly 806 is in fluid communication with the expandable cylinder 810. In addition, the pump assembly 806 can be in fluid communication with the fluid reservoir 802 via the catheter connector 803. The fluid reservoir 802 can be implanted in the abdomen of the user. The expansion chamber or portion 822 of the expandable cylinder 810 can be disposed within the penis. The first end portion 824 of the expandable cylinder 810 can be at least partially disposed within the crown portion of the penis. The second end portion 828 can be implanted in the pubic region PR of the patient, wherein the rear end 832 is proximal to the pubic bone PB.

[0102] To implant the inflatable cylinder 810, 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 the top of the scrotum). From the penoscrotal incision, the surgeon can dilate the patient's corpora cavernosa to prepare the patient to receive the inflatable cylinder 810. The corpora cavernosa are one of two parallel columns of erectile tissue that form the back of the body of the penis, e.g., two elongated columns that extend roughly the entire length of the penis. The surgeon will also dilate two areas of the pubic region to prepare the patient to receive the second end portion 828. The surgeon can measure the length of the corpora cavernosa from the incision and the dilated area of ​​the pubic region to determine the appropriate size of the inflatable cylinder 810 to be implanted.

[0103] After the patient is ready, the penile prosthesis 800 is implanted in the patient. The end of the first end portion 824 of each inflatable cylinder 810 can be attached to a suture. The other end of the suture can be attached to a needle member (e.g., a Keith needle). The needle member is inserted into the incision and enters the expanded corpus cavernosum. The needle member is then forced through the crown of the penis. The surgeon pulls the suture to pull the inflatable cylinder 810 into the corpus cavernosum. This is done for each inflatable cylinder 810 in a pair. Once the inflated chamber 822 is in place, the surgeon can remove the suture from the end. The surgeon then inserts the second end portion 828. The surgeon inserts the rear end of the inflatable cylinder 810 into the incision and pushes the second end portion 828 toward the pubic bone PB until each inflatable cylinder 810 is in place.

[0104] The pump ball 808 of the pump assembly 806 can be squeezed or pressed by the user to facilitate the transfer of fluid from the fluid reservoir 802 to the expandable cylinder 810. For example, in the inflated mode, when the user operates the pump ball 808, the pump ball 808 can receive fluid from the fluid reservoir 802 and then output the fluid to the expandable cylinder 810. When the user switches to the deflated mode, at least some of the fluid can be automatically transferred back to the fluid reservoir 802 (due to the pressure differential from the expandable cylinder 810 to the fluid reservoir 802). The user can then squeeze the expandable cylinder 810 to facilitate further transfer of fluid through the pump ball 808 to the fluid reservoir 802.

[0105] Although certain features of the embodiments are shown as described herein, it will now be apparent to those skilled in the art that numerous variations, substitutions, modifications and equivalents will occur to them. Therefore, it should be understood that the appended claims are intended to cover all such variations and modifications that fall within the scope of the embodiments.

Claims

1. An expandable penis prosthesis, comprising: a fluid reservoir configured to hold a fluid; expandable member; and a pump assembly configured to transfer fluid between the fluid reservoir and the expandable member, the pump assembly comprising a pump ball, 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 comprising a movable valve element configured to move between an expanded position and a deflated position within a bore of the valve body, The movable valve element defines a fluid path through the bore in an expanded position to transfer fluid from the pump ball to the second fluid port, and the movable valve element is configured to change the fluid path through the bore to transfer fluid from the second fluid port to the first fluid port when moved to a deflated position so that the pump ball is bypassed.

2. The inflatable penile prosthesis according to claim 1, wherein: The push valve includes a biasing member that biases the movable valve element to the expanded position.

3. The inflatable penile prosthesis according to claim 2, wherein: The biasing member includes a spring.

4. The inflatable penile prosthesis according to any one of claims 1 to 3, wherein: The push valve includes a poppet valve having a collar member.

5. The inflatable penile prosthesis according to any one of claims 1 to 4, wherein: The movable valve element is configured to move in a linear direction to the deflated position based on a single momentary push of the movable valve element by a user.

6. The inflatable penile prosthesis according to any one of claims 1 to 5, wherein: The pump assembly includes a button member that surrounds a portion of the movable valve element when the movable valve element is in an expanded position.

7. The inflatable penile prosthesis according to claim 6, wherein: The pump assembly includes a feedback component disposed between the button component and the movable valve element, the feedback component configured to provide at least one of tactile feedback or audible feedback in response to the movable valve element being moved to the deflated position.

8. The inflatable penile prosthesis according to any one of claims 1 to 7, wherein: When the movable valve element is in the expanded position, a portion of the movable valve element extends outside the valve body, and when the movable valve element is in the deflated position, the portion of the movable valve element is disposed within the valve body.

9. The inflatable penile prosthesis according to any one of claims 1 to 8, wherein: The valve body includes a refill valve aligned with the first fluid port, the refill valve being configured to transfer fluid from the fluid reservoir to the pump ball when the movable valve element is in an expanded position.

10. The inflatable penile prosthesis according to claim 9, wherein: A longitudinal axis of the refill valve is aligned with a longitudinal axis of the first fluid port.

11. The inflatable penile prosthesis according to any one of claims 1 to 10, wherein: The valve body includes an expansion valve disposed in a fluid passage between the pump ball and the bore.

12. The inflatable penile prosthesis according to any one of claims 1 to 11, wherein: The movable valve element includes a first movable member and a second movable member configured to move independently relative to each other.

13. The inflatable penile prosthesis according to any one of claims 1 to 12, wherein: The valve body includes a refill valve and an inflation valve, wherein the refill valve and the inflation valve are not used when the movable valve element is in the deflated position.

14. A method for controlling the direction of a fluid through a pump assembly of an inflatable penile prosthesis, the method comprising: The pump assembly transfers fluid from the fluid reservoir to the expandable member, comprising: transferring fluid from the fluid reservoir to a pump ball via a refill valve; transferring fluid from the pump ball to the expandable member via an inflation valve and a push valve having a movable valve element; urging the movable valve element along an axis to a deflated position to change a fluid path through a valve body of the pump assembly; and Fluid is transferred from the expandable member to the fluid reservoir via the push valve such that the fluid is not transferred through the pump ball.

15. The method according to claim 14, wherein: When the movable valve element is in the deflated position, the refill valve and the inflation valve are not used to transfer fluid from the inflation member to the fluid reservoir.

16. An expandable penile prosthesis, comprising: a fluid reservoir configured to hold a fluid; expandable member; and a pump assembly configured to transfer fluid between the fluid reservoir and the expandable member, the pump assembly comprising a pump ball, 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 comprising a movable valve element configured to move between an expanded position and a deflated position within a bore of the valve body, The movable valve element defines a fluid path through the bore in an expanded position to transfer fluid from the pump ball to the second fluid port, and the movable valve element is configured to change the fluid path through the bore to transfer fluid from the second fluid port to the first fluid port when moved to a deflated position so that the pump ball is bypassed.

17. The inflatable penile prosthesis of claim 16, wherein: The push valve includes a biasing member that biases the movable valve element to the expanded position.

18. The inflatable penile prosthesis of claim 16, wherein: The push valve includes a poppet valve having a collar member.

19. The inflatable penile prosthesis of claim 16, wherein: The movable valve element is configured to move in a linear direction to the deflated position based on a single momentary push of the movable valve element by a user.

20. The inflatable penile prosthesis of claim 16, wherein: The pump assembly includes a button member that surrounds a portion of the movable valve element when the movable valve element is in an expanded position.

21. The inflatable penile prosthesis of claim 20, wherein: The pump assembly includes a feedback component disposed between the button component and the movable valve element, the feedback component configured to provide at least one of tactile feedback or audible feedback in response to the movable valve element being moved to the deflated position.

22. The inflatable penile prosthesis of claim 16, wherein: When the movable valve element is in the expanded position, a portion of the movable valve element extends outside the valve body, and when the movable valve element is in the deflated position, the portion of the movable valve element is disposed within the valve body.

23. The inflatable penile prosthesis of claim 16, wherein: The valve body includes a refill valve aligned with the first fluid port, the refill valve being configured to transfer fluid from the fluid reservoir to the pump ball when the movable valve element is in an expanded position.

24. The inflatable penile prosthesis of claim 16, wherein: The valve body includes an expansion valve disposed in a fluid passage between the pump ball and the bore.

25. The inflatable penile prosthesis of claim 16, wherein: The movable valve element includes a first movable member and a second movable member configured to move independently relative to each other.

26. The inflatable penile prosthesis of claim 16, wherein: The valve body includes a refill valve and an inflation valve, wherein the refill valve and the inflation valve are not used when the movable valve element is in the deflated position.

27. A pump assembly for an inflatable penile prosthesis, comprising: a push valve movably coupled to the valve body, the push valve including a movable valve element configured to move within a bore of the valve body between an expanded position and a deflated position; as well as a plurality of fluid transfer ports including 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 expandable member, The movable valve element defines a fluid path through the bore in an expanded position to transfer fluid from the pump ball to the second fluid port, and the movable valve element is configured to change the fluid path through the bore to transfer fluid from the second fluid port to the first fluid port when moved to a deflated position so that the pump ball is bypassed.

28. A pump assembly according to claim 27, wherein: The movable valve element comprises a cylindrical one-piece body having at least two sections of different diameters.

29. The pump assembly of claim 27, wherein: The first fluid port includes a first tubular member and the second fluid port includes a second tubular member configured to be fluidly coupled to the first cylindrical member of the expandable member and a third tubular member configured to be fluidly coupled to the second cylindrical member of the expandable member.

30. The pump assembly of claim 27, further comprising: a refill valve disposed within the valve body at a position aligned with a longitudinal axis of the first fluid port; as well as An expansion valve is disposed in the fluid passage between the bore and the pump ball.

31. A pump assembly according to claim 30, wherein: The movable valve element is configured to move from an expanded position to a deflated position along an axis that is generally orthogonal to a longitudinal axis of the first fluid port.

32. The pump assembly of claim 27, further comprising: An anti-autoinflation valve is disposed in the fluid passage between the first fluid port and the second fluid port.

33. The pump assembly of claim 27, wherein: When the movable valve element is in the expanded position, a portion of the movable valve element extends outside the valve body, and the pump assembly further includes: a button member surrounding the portion of the movable valve element; and A feedback component is disposed between the button component and an end portion of the movable valve element, the feedback component being configured to provide at least one of tactile feedback or audible feedback in response to the movable valve element being moved to the deflated position.

34. A method for controlling the direction of a fluid through a pump assembly of an inflatable penile prosthesis, the method comprising: The pump assembly transfers fluid from the fluid reservoir to the expandable member, comprising: transferring fluid from the fluid reservoir to a pump ball via a refill valve; transferring fluid from the pump ball to the expandable member via an inflation valve and a push valve having a movable valve element; urging the movable valve element along an axis to a deflated position to change a fluid path through a valve body of the pump assembly; and Fluid is transferred from the expandable member to the fluid reservoir via the push valve such that the fluid is not transferred through the pump ball.

35. The method of claim 34, wherein: When the movable valve element is in the deflated position, the refill valve and the inflation valve are not used to transfer fluid from the inflation member to the fluid reservoir.

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