Electronically implantable penile prosthesis

Abstract

According to an embodiment, the inflatable penile prosthesis (100) includes a fluid reservoir (102) configured to hold a fluid, an inflatable member (104), and an electronic pump assembly (106) configured to transfer fluid between the fluid reservoir and the inflatable member. The electronic pump assembly includes a pump (120), an active valve (118) disposed in parallel with the pump, and a controller (114) configured to control the pump and the active valve.

Description

Technical Field

[0005] ,

[0001] [Cross - Reference to Related Applications] This application is a continuation of, and claims priority to, U.S. Non - Provisional Application No. 18 / 068,074, filed on Dec. 19, 2022, entitled "ELECTRONIC IMPLANTABLE PENILE PROSTHESIS", which claims priority to U.S. Provisional Patent Application No. 63 / 265,808, filed on Dec. 21, 2021, entitled "ELECTRONIC IMPLANTABLE PENILE PROSTHESIS", the disclosures of which are hereby incorporated by reference in their entirety.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 265,808, filed on Dec. 21, 2021, the disclosure of which is hereby incorporated by reference in its entirety.

[0003] This disclosure generally relates to body implants, and more specifically to body implants such as electronic implantable penile prostheses.

Background Art

[0004] One treatment for male erectile dysfunction is the implantation of a penile prosthesis to erect the penis. Some existing penile prostheses include inflatable cylinders or members that can be inflated or deflated using a pump mechanism. The pump mechanism includes a pump that can be implanted in the scrotum and manually collapsed by the user to move fluid from a reservoir into the cylinder to cause an erection. For some patients, the manual pumping procedure can be relatively difficult.

Summary of the Invention

Means for Solving the Problems

[0005] Depending on the embodiment, an inflatable penile prosthesis includes a fluid reservoir configured to hold fluid, an inflatable member, and an electronic pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member. The electronic pump assembly includes a pump, an active valve positioned in parallel with the pump, and a controller configured to control the pump and the active valve.

[0006] In some embodiments, an inflatable penile prosthesis may include one or more (or any combination thereof) of the following features: The pump may include an electromagnetic pump. The pump may include a piezoelectric pump. The electronic pump assembly may include an antenna configured to receive radio control signals from an external device. The controller may be configured to control at least one of the pump or an active valve based on the radio control signals. In some examples, the pump is a first pump, and the electronic pump assembly includes a second pump. The second pump may be arranged in parallel with the first pump. The second pump may be configured to operate out of phase with the first pump. The second pump may be arranged in series with the first pump. The pump may include one or more passive check valves.

[0007] Depending on the embodiment, the inflatable penile prosthesis includes a fluid reservoir configured to hold fluid, an inflatable member, and an electronic pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member. The electronic pump assembly includes a first pump, a second pump, an active valve, and a controller configured to control the first pump, the second pump, and the active valve.

[0008] In some embodiments, an inflatable penile prosthesis may include any (or any combination thereof) of the above / below features: The first pump and active valve may be in parallel with each other. The active valve is configured to transition between an open position through which fluid flows and a closed position through which fluid is prevented from flowing. The electronic pump assembly may include a pressure sensor, and the controller is configured to control at least one of the first pump, the second pump, or the active valve based on the pressure measured by the pressure sensor. The pressure sensor may be connected to an inflatable member. The pressure sensor may be connected to a fluid reservoir. The active valve may be a first active valve, and the electronic pump assembly may include a second active valve. The second active valve may be in series with the first pump. The electronic pump assembly may include a sealed enclosure, which includes a sealed fluid chamber. The sealed fluid chamber includes the first pump, the second pump, and the active valve. The controller is located outside the sealed fluid chamber, although it is inside a sealed enclosure.

[0009] Depending on the embodiment, a method for operating an inflatable penile prosthesis includes the steps of: receiving a wireless control signal from an external device via the antenna of an electronic pump assembly; generating a first control signal by a controller to control the active valve of the electronic pump assembly; generating a second control signal by the controller to control the pump of the electronic pump assembly; operating the active valve to the closed position in response to the first control signal; and operating the pump in response to the second control signal to transfer fluid from the fluid reservoir to the inflatable member until the pressure in the inflatable member reaches a threshold level. In some examples, the method includes the steps of: generating a third control signal by a controller to control the active valve; and operating the active valve to the open position in response to the third control signal to transfer at least a portion of the fluid from the inflatable member to the fluid reservoir. [Brief explanation of the drawing]

[0010] [Figure 1] This figure shows an inflatable penile prosthesis having an electronic pump assembly according to its configuration. [Figure 2A] This figure shows an inflatable penile prosthesis having an electronic pump assembly according to another embodiment. [Figure 2B] This figure shows an example of a sealed fluid chamber for an electronic pump assembly according to its configuration. [Figure 3] This figure shows an example of an electronic pump assembly depending on the configuration. [Figure 4] This figure shows an inflatable penile prosthesis having an electronic pump assembly according to another embodiment. [Figure 5] This flowchart illustrates the exemplary operation of an electronic pump assembly in different configurations. [Modes for carrying out the invention]

[0011] The disclosure of the present invention relates to an inflatable penile prosthesis including an electronic pump assembly for transferring fluid between a fluid reservoir and an inflatable member. The electronic pump assembly can wirelessly communicate with an external device (e.g., a computer, smartphone, tablet, pendant, key fob, etc.) to control the inflatable penile prosthesis (e.g., to inflate or deflate the inflatable member, to update one or more control parameters). In some examples, the electronic pump assembly includes a primary battery (e.g., a non-rechargeable battery). In some examples, the electronic pump assembly includes a rechargeable battery configured to be recharged by an external charger.

[0012] An electronic pump assembly includes one or more pumps (e.g., electronically controlled pumps such as one or more electromagnetic pumps or piezoelectric pumps), one or more active valves, and a controller. The controller can control the expansion and contraction of an inflatable member based on control signals that it operates and transmits to the pumps and active valves. The pumps can be unidirectional or bidirectional. In some examples, the electronic pump assembly includes one or more pumps in parallel with the active valves. In some examples, the pumps can transport fluid to the inflatable member during the expansion cycle, and the active valves can be moved to an open position to allow the fluid to be transported back to the fluid reservoir during the contraction cycle. The pumps can transport fluid to the inflatable member at a relatively high pressure ratio on demand. In some examples, the electronic pump assembly includes two or more parallel pumps, such as a first pump and a second pump, where the first and second pumps are configured to operate out of phase with each other, thereby increasing the efficiency of the pumping operation. In some cases, the use of parallel pumps operating out of phase can allow the pumps to operate at a lower frequency, thereby reducing power consumption and improving battery life. In some cases, an electronic pump assembly may include one or more pumps in series with the pump, thereby increasing the amount of fluid that can be transferred to the inflatable member during the period.

[0013] Each pump may include one or more passive check valves that move to a closed position in response to positive pressure between the inflatable member and the fluid reservoir. In some examples, an active valve may move to a closed position to maintain (e.g., substantially maintain) the pressure in the inflatable member. In some examples, an active valve may move to an open position to release the pressure in the inflatable member and / or to allow backflow into the inflatable member. In some examples, the electronic pump assembly includes a single active valve. In some examples, the electronic pump assembly includes multiple active valves. For example, one or more active valves may be in series with the pump.

[0014] The electronic pump assembly may include a pressure sensor configured to sense the pressure in an inflatable penile prosthesis. In some examples, the pressure sensor is coupled to the inflatable member. The pressure sensor can measure the pressure within the inflatable member. A controller can receive the measured pressure from the pressure sensor and automatically control the active valve and / or pump to regulate the pressure within the inflatable member. In some examples, the pressure sensor is connected to a fluid reservoir. In some examples, the pressure sensor can detect intraperitoneal pressure (which may increase during activities such as exercise), and the controller can control the active valve and pump to minimize or prevent accidental inflation.

[0015] Figure 1 shows an inflatable penile prosthesis 100 in an embodiment, the prosthesis 100 having an electronic pump assembly 106 that can improve the inflation and / or deflation operation of its inflatable member 104. The inflatable penile prosthesis 100 includes a fluid reservoir 102, an inflatable member 104, and an electronic pump assembly 106 configured to transfer fluid between the fluid reservoir 102 and the inflatable member 104. The inflatable member 104 can be implanted in the user's corpus cavernosum, and the fluid reservoir 102 can be implanted in the user's abdominal cavity or pelvic cavity (for example, the fluid reservoir 102 can be implanted in the lower part of the user's abdominal cavity or the upper part of the user's pelvic cavity). In some examples, only at least a portion of the electronic pump assembly 106 may be implemented in the patient's body.

[0016] The inflatable member 104 may have the function of expanding when fluid is injected into its cavity. For example, when fluid is injected into the inflatable member 104, the inflatable member 104 may increase its length and / or width, and increase its rigidity. In some examples, the inflatable member 104 may include one pair of inflatable cylinders or at least two cylinders, for example, a first cylinder member and a second cylinder member. The volumetric capacity of the inflatable member 104 may depend on the size of the inflatable cylinders. In some examples, the volume of fluid in each cylinder may vary from about 10 milliliters in smaller cylinders to about 70 milliliters in larger ones. In some examples, the first cylinder member may be larger than the second cylinder member. In other examples, the first cylinder member may be the same size as the second cylinder member.

[0017] The fluid reservoir 102 may include a container having an internal chamber configured to hold or contain the fluid used to inflate the inflatable member 104. The volumetric capacity of the fluid reservoir 102 can vary depending on the size of the inflatable penile prosthesis 100. In some examples, the volumetric capacity of the fluid reservoir 102 can range from 3 cubic centimeters to 150 cubic centimeters. In some examples, the fluid reservoir 102 is made of the same material as the inflatable member 104. In other examples, the fluid reservoir 102 is made 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.

[0018] The inflatable penile prosthesis 100 may include a first conduit connector 103 and a second conduit connector 105. Each of the first conduit connector 103 and the second conduit connector 105 may define a lumen configured to transfer fluid to and from the pump assembly 106. The first conduit connector 103 may connect the electronic pump assembly 106 and the fluid reservoir 102 so that fluid can be transferred between the electronic pump assembly 106 and the fluid reservoir 102 through the first conduit connector 103. For example, the first conduit connector 103 may define a first lumen configured to transfer fluid between the electronic pump assembly 106 and the fluid reservoir 102. The first conduit connector 103 may include one or more tubular members for transferring fluid between the electronic pump assembly 106 and the fluid reservoir 102.

[0019] The second conduit connector 105 can connect the pump assembly 106 and the inflatable member 104 so that fluid can be transferred between the electronic pump assembly 106 and the inflatable member 104 through the second conduit connector 105. For example, the second conduit connector 105 can define a second lumen configured to transfer fluid between the electronic pump assembly 106 and the inflatable member 104. The second conduit connector 105 may include one or more tubular members for transferring fluid between the electronic pump assembly 106 and the inflatable member 104. In some examples, the first conduit connector 103 and the second conduit connector 105 may be made of silicone rubber material. In some examples, the electronic pump assembly 106 may be connected directly to the fluid reservoir 102.

[0020] The electronic pump assembly 106 can automatically transfer fluid between the fluid reservoir 102 and the expandable member 104 without the user manually operating the pump (e.g., squeezing and releasing a pump bulb). The electronic pump assembly 106 includes one or more pumps 120, one or more active valves 118, a controller 114 configured to control the pumps 120 and the active valves 118, and one or more pressure sensors 130. For example, the controller 114 can control the pump 120 to pump fluid between the fluid reservoir 102 and the expandable member 104. The controller 114 can control the active valve 118 to shift between an open position and a closed position. The pump 120 is configured to transfer fluid (on demand) to the expandable member 104 at a relatively high pressure (e.g., up to about 20 pounds per square inch (PSI)).

[0021] The electronic pump assembly 106 can include a battery 116 configured to supply power to the controller 114 and other components on the electronic pump assembly 106. In some examples, the battery 116 is a non-rechargeable battery. In some examples, the battery 116 is a rechargeable battery. In some examples, the electronic pump assembly 106 (or a portion thereof) (or the controller 114) is configured to be connected to an external charger to charge the battery 116. In some examples, the electronic pump assembly 106 can define a charging interface configured to connect to an external charger. In some examples, the charging interface includes a universal serial bus (USB) interface configured to receive a USB charger. In some examples, the charging technology can be electromagnetic or piezoelectric.

[0022] The electronic pump assembly 106 may include an antenna 112 configured to wirelessly transmit (and receive) a radio signal 109 to an external device 101. The external device 101 can be any type of component that can communicate with the electronic pump assembly 106. The external device 101 may be a computer, smartphone, tablet, pendant, key fob, etc. The user can use the external device 101 to control the inflatable penile prosthesis 100. In some examples, the user can use the external device 101 to inflate or deflate the inflatable member 104. For example, in response to the user using the external device 101 to initiate an inflation cycle (e.g., by selecting a user controller on the external device 101), the external device 101 may transmit a radio signal 109 (received through the antenna 112) to the electronic pump assembly 106 to initiate the inflation cycle, and the controller 114 may control the active valve 118 and pump 120 to inflate the inflatable member 104 to a target inflation pressure. In some cases, the controller 114 can operate the pump to move the fluid from the fluid reservoir 102 to the expandable member 104 by closing the active valve.

[0023] In some examples, in response to a user initiating a deflation cycle using an external device 101 (e.g., selecting a user controller on the external device 101), the external device 101 can transmit a radio signal 109 (received through the antenna 112) to the electronic pump assembly 106 to initiate the deflation cycle, and the controller 114 can control the active valve 118 (and in some examples, the pump 120) to transfer fluid from the inflatable member 104 to the fluid reservoir 102. For example, the controller 114 can control the active valve 118 to move to the open position to allow fluid to transfer from the inflatable member 104 to the fluid reservoir 102. In some examples, the controller 114 can control one or more pumps 120 to further transfer fluid from the inflatable member 104 to the fluid reservoir 102 during the deflation cycle. In some examples, during the deflation cycle, the fluid is transferred and returned until the pressure in the inflatable member 104 reaches the partial inflation pressure. In some cases, the controller 114 can automatically decide to initiate a contraction cycle, and as a result, control the active valve 118 (and in some cases, the pump 120) to transfer and return the fluid to the fluid reservoir 102.

[0024] Controller 114 can be any type of controller configured to control the operation of pump 120 and active valve 118. In some examples, controller 114 is a microcontroller. In some examples, controller 114 includes one or more drivers configured to drive pump 120 and active valve 118. In some examples, the driver is a separate component from controller 114. Controller 114 can be communicatively coupled to active valve 118, pump 120, and pressure sensor 130. In some examples, controller 114 is connected to active valve 118, pump 120, and pressure sensor 130 through a wired data line. Controller 114 can include processor 113 and memory device 115. Processor 113 can be formed within a substrate configured to execute one or more machine-executable instructions or some software, firmware, or a combination thereof. Processor 113 can be semiconductor-based, i.e., the processor can include a semiconductor material capable of executing digital logic. Memory device 115 can store information in a format that can be read and / or executed by processor 113. Memory device 115 can store executable instructions that cause processor 113 to perform certain operations discussed herein when executed by processor 113. Controller 114 can control them by receiving data through pressure sensor 130 and / or external device 101 and transmitting control signals to active valve 118 and / or pump 120.

[0025] The memory device 115 can store control parameters that can be set or modified by the user and / or physician using the external device 101. In some examples, the control parameters may include a target inflation pressure and / or partial inflation pressure. In some examples, the target inflation pressure is the maximum (or desired) acceptable pressure within the inflatable member 104. In some examples, the partial inflation pressure is a pressure threshold that can more faithfully simulate the user's natural sensation and / or personal comfort. The user or physician can update the control parameters using the external device 101, communicate them to the controller 114 via the antenna 112, and then perform the update in the memory device 115.

[0026] The external device 101 can communicate with the electronic pump assembly 106 over a network. In some examples, the network includes short-range wireless networks such as near-field communication (NFC), Bluetooth, or infrared communication. In some examples, the network may include the internet (e.g., Wi-Fi) and / or other types of data networks, such as local area networks (LANs), wide area networks (WANs), cellular networks, satellite networks, or other types of data networks.

[0027] In some examples, the electronic pump assembly 106 includes a single pump 120, such as pump 120-1. Pump 120-1 may be located in parallel with the active valve 118. In some examples, the electronic pump assembly 106 includes multiple pumps 120. For example, pump 120 includes pump 120-1 and pump 120-2. In some examples, pump 120-1 is located in a fluid passage 125 used to fill the inflatable member 104 (e.g., during an expansion cycle). In some examples, pump 120-2 is located in a fluid passage 127 used to fill the inflatable member 104 (e.g., during an expansion cycle). In some examples, pump 120-2 is located in parallel with pump 120-1. Pump 120-1 can transport fluid at a first flow rate, and pump 120-1 can transport fluid at a second flow rate. In some examples, the first flow rate is substantially the same as the second flow rate. In some cases, the first flow rate is different from the second flow rate.

[0028] In some examples, pump 120 may include more than two pumps 120, for example, three, four, five, six, or more than six pumps 120. For example, pump 120 may include a third pump in parallel with pump 120-2, a fourth pump in parallel with the third pump, and so on. In some examples, pump 120 may include one or more pumps 120 in series with one or more other pumps 120. For example, one or more pumps 120 may be in series with pump 120-1. In some examples, one or more pumps 120 may be in series with pump 120-2.

[0029] Each pump 120 is an electronically controlled pump. Each pump 120 can be electronically controlled by a controller 114. For example, each pump 120 can be connected to the controller 114 and receive signals to operate each pump 120. The pump 120 can be unidirectional, capable of transferring fluid from the fluid reservoir 102 to the inflatable member 104 (or from the inflatable member 104 to the fluid reservoir 102). In some examples, the pump 120 can be bidirectional, capable of transferring fluid from the fluid reservoir 102 to the inflatable member 104 and from the inflatable member 104 to the fluid reservoir 102. In some examples, the pump 120 is either unidirectional or bidirectional. In some examples, the pump 120 includes a combination of one or more unidirectional pumps and one or more bidirectional pumps.

[0030] In some examples, the pump 120 is an electromagnetic pump that uses electromagnetic force to move a fluid between a fluid reservoir 102 and an expandable member 104. In the case of an electromagnetic pump, the magnetorheological fluid is set at a certain angle with respect to the direction in which the fluid moves, and an electric current is passed through it.

[0031] In some examples, pump 120 is a piezoelectric pump. In some examples, the piezoelectric pump may be a diaphragm micropump that uses the operation of a diaphragm to drive a fluid. In some examples, the piezoelectric pump may include one or more piezoelectric pumps (e.g., piezoelectric elements) that can be implemented by a substrate layer of high-voltage piezoelectric elements (e.g., a single substrate layer) or by multiple substrate layers of low-voltage piezoelectric elements (e.g., a multilayer substrate layer). In some examples, pump 120 includes a plurality of micropumps (e.g., piezoelectric-driven micropumps) arranged on one or more substrates (e.g., wafers). In some examples, the micropumps include a silicon-based material. In some examples, the micropumps include a metal (e.g., steel)-based material. In some examples, pump 120 is non-mechanical (e.g., has no moving parts).

[0032] In some examples, when there are multiple pumps 120, each pump 120 can be of the same type (for example, all pumps 120 may be either electromagnetic pumps or piezoelectric pumps). In some examples, one or more pumps 120 may be different from one or more other pumps 120. For example, pump 120 may include various types of piezoelectric pumps or various types of electromagnetic pumps. Pump 120-1 may be a piezoelectric pump having a first number of micropumps, and pump 120-2 may be a piezoelectric pump having a second number of micropumps (in this case, the second number may be different from the first number). Pump 120-1 may be an electromagnetic pump, and pump 120-2 may be a piezoelectric pump.

[0033] Pump 120 may include one or more passive check valves. Passive check valves can help maintain pressure within the inflatable member 104. In some examples, pump 120 may include a single passive check valve. In some examples, pump 120 may include multiple passive check valves, such as two or more passive check valves. Each passive check valve of pump 120 cannot be directly controlled by the controller 114 but can be controlled based on the pressure between the inflatable member 104 and the fluid reservoir 102. Passive check valves can transition between an open position (where fluid is allowed to flow through the passive check valve) and a closed position (where fluid is prevented from flowing through the passive check valve). In some examples, passive check valves transition to the closed position in response to positive pressure between the inflatable member 104 and the fluid reservoir 102. In some cases, the passive check valve moves to the open position in response to the negative pressure between the expandable member 104 and the fluid reservoir 102.

[0034] In some cases, the use of two parallel pumps (e.g., pump 120-1, pump 120-2) (or more than two parallel pumps 120) can increase the amount of fluid that can be transferred to the inflatable member 104. In some cases, the pumps 120 can be operated out of phase with each other to improve the efficiency of the electronic pump assembly 106. Two parallel pumps (e.g., pump 120-1, pump 120-2) operating out of phase with each other (e.g., 180-degree phase difference) can allow the output pressure of pump 120-1 to improve valve closure of pump 120-2, thereby improving overall performance (and vice versa). The use of parallel pumps 120 operating out of phase with each other can allow the pumps 120 to operate at a lower frequency, thereby reducing power consumption (and thus extending battery life). Furthermore, a smoother flow rate can be achieved, resulting in less vibration and an improved patient experience. As described above, one or more pumps 120 can be connected in series with one or more parallel pumps 120. For example, an additional pump 120 can be connected in series with pump 120-1 and / or with pump 120-2. Series pump operation can enable pressure doubling when two pumps 120 of similar performance are used. In some examples, two or more series-arranged pumps 120 can be operated in the same phase.

[0035] Phase shift can mean two or more control signals that have a phase relationship with respect to each other such that one control signal is at its positive peak and at the same time another control signal is at (or near) its negative peak. Pump 120-1 can be operated according to a first control signal (generated by controller 114), and pump 120-2 can be operated according to a second control signal (generated by controller 114). The first and second control signals can control pumps 120-1 and 120-2, respectively, to operate out of phase with respect to each other. Each of the first and second control signals can define a set of operating states, e.g., a first state and a second state. For example, each of the first and second control signals can include a waveform having a set of first states (either a high state or a low state) and second states (either a low state or a high state). The first state can indicate that the diaphragm element moves in a first direction, and the second state can indicate that the diaphragm element moves in a second direction (opposite to the first direction). The first signal can indicate a first state during the first period, a second state during the subsequent second period, a first state during the subsequent third period, a second state during the subsequent fourth period, and so on. The second signal can indicate a second state during the first period, a first state during the subsequent second period, a second state during the third period, a first state during the fourth period, and so on.

[0036] The active valve 118 can be an electronically controlled valve. The active valve 118 can be electronically controlled by a controller 114. For example, the active valve 118 can be connected to a controller 114 and can receive signals to shift the active valve 118 between an open position through which fluid flows and a closed position through which fluid is prevented from flowing. In some examples, the active valve 118 is located in a fluid passage 124 used to empty the inflatable member 104 (e.g., in a deflation cycle). In some examples, the active valve 118 can be moved to a closed position to maintain (e.g., substantially maintain) the pressure in the inflatable member 104. In some examples, the active valve 118 can be moved to an open position to release the pressure in the inflatable member 104 and / or to allow backflow into the inflatable member 104 in order to transfer and return the fluid to a fluid reservoir 102. In some cases, the active valve 118 can be used to maintain (e.g., substantially maintain) the partial expansion pressure.

[0037] In some examples, the electronic pump assembly 106 includes a single active valve 118. In some examples, the electronic pump assembly 106 includes multiple active valves 118. In some examples, one or more additional active valves 118 may be in series with pumps 120-1 and / or pumps 120-2. In some examples, additional active valves 118 (e.g., series active valves 118) may be located in a partial fluid passage 117 connected to a fluid reservoir 102. In some examples, additional active valves 118 (e.g., series active valves 118) may be located in a partial fluid passage 119 connected to an inflatable member 104. These additional active valves 118 can reduce leakage when at maximum or partial expansion pressure.

[0038] The electronic pump assembly 106 may include one or more pressure sensors 130 configured to sense the pressure of the inflatable penile prosthesis 100. In some examples, the electronic pump assembly 106 includes a single pressure sensor 130. In some examples, the electronic pump assembly 106 includes multiple pressure sensors 130. For example, the pressure sensors 130 may include a pressure sensor 130 configured to measure the pressure of the inflatable member and / or a pressure sensor 130 configured to measure the pressure of the fluid reservoir 102. In some examples, the electronic pump assembly 106 may include additional pressure sensors 130 that can be positioned at various locations within it. For example, the pressure sensors 130 may be located between the active valves 118. In some examples, the pressure sensors 130 may be located between two pumps 120 connected in series. In some examples, the pressure sensors 130 may be located between two pumps 120 connected in parallel. In some examples, the pressure sensors 130 may be located between the active valves 118 and the pumps 120. The pressure sensor 130 can be communicatively coupled to the controller 114 so that the controller 114 can receive signals from the pressure sensor 130. In some examples, the pressure sensor 130 is configured to sense the amount of fluid being transferred to the inflatable member 104 and to send one or more signals to the controller 114 indicating the amount of fluid transferred.

[0039] In some examples, the pressure sensor 130 is positioned between the pump 120 and the inflatable member 104, as shown in Figure 1. The pressure sensor 130 can measure the pressure inside the inflatable member 104. The controller 114 can receive the measured pressure from the pressure sensor 130 and automatically control the active valve 118 and / or pump 120 to adjust the pressure. For example, the controller 114 can move the active valve 118 to the open position if the measured pressure is higher than the target inflation pressure (to allow fluid to be transferred to and returned to the fluid reservoir 102), and can move the active valve 118 to the closed position when the measured pressure reaches the target inflation pressure to maintain the pressure inside the inflatable member 104. In some examples, the pressure sensor 130 is positioned between the pump 120 and the fluid reservoir 102. In some examples, the pressure sensor 130 can detect intra-abdominal pressure (which may increase during activities such as exercise), and the controller 114 can control the active valve 118 and pump to minimize or prevent accidental inflation.

[0040] In some examples, the pressure sensor 130 is included within the inflatable member 104. In some examples, the pressure sensor 130 is incorporated into the cylinder wall of the inflatable member 104. In some examples, when incorporated into the cylinder wall, the pressure sensor 130 can monitor the condition of the cylinder material and monitor changes in the cylinder material up to a point where it may be necessary to replace the cylinder. In this case, the controller 114 can send information about potential issues to an external device 101 over the network.

[0041] In some examples, the pressure sensor 130 is configured to sense the pressure level and send one or more signals to the controller 114 indicating the pressure level at other locations in the inflatable member 104, the fluid reservoir 102, and / or the inflatable penile prosthesis 100. In some examples, the pressure sensor 130 is configured to monitor the flow rate (e.g., bidirectional flow rate). The controller 114 can control the starting (and stopping) of the pump 120 and / or the active valve 118 based on signals received from the pressure sensor 130.

[0042] In some examples, the electronic pump assembly 106 includes a sealed enclosure 108 that encloses the components of the electronic pump assembly 106. The sealed enclosure 108 can be an airtight (or substantially airtight) container. The sealed enclosure 108 may contain one or more metal-based materials. In some examples, the sealed enclosure 108 is a titanium container. In some examples, titanium is the only material in contact with the patient. In some examples, the sealed enclosure 108 includes one or more non-metal-based materials (e.g., ceramics). In some examples, part of the sealed enclosure 108 is a metal-based material and part is a non-metal-based material. In some examples, the sealed enclosure 108 defines a penetration (e.g., a sealed penetration, an electrical penetration, a penetration connector, etc.) for receiving / transmitting radio signals to / from an external device 101. In some examples, the penetration includes a metal-based material and an insulator-based material (e.g., ceramics).

[0043] In some examples, the electronic pump assembly 106 includes a sealed fluid chamber 110 located inside a sealed enclosure 108. The sealed fluid chamber 110 can be a separate, airtight (or substantially airtight) container within the sealed enclosure 108. The sealed fluid chamber 110 can include one or more metal-based materials. In some examples, the sealed fluid chamber 110 is a titanium container. The sealed fluid chamber 110 can isolate the fluid from electronic equipment (e.g., a controller 114, a battery 116, etc.). In other words, the electronic equipment section can be isolated (e.g., completely isolated) from the fluid by the sealed fluid chamber 110. The sealed fluid chamber 110 can be fluidically connected to a fluid reservoir 102 and an expandable member 104. The sealed fluid chamber 110 can include an active valve 118, a pump 120, and a pressure sensor 130. In some examples, the sealed fluid chamber 110 defines a penetration (e.g., a sealed penetration, an electrical penetration, a penetration connector, etc.) for receiving / transmitting signals to / from the controller 114. In some examples, the sealed fluid chamber 110 located within a sealed enclosure 108 creates a double-sealed system. In some examples, the electronic pump assembly 106 contains only one sealed enclosure (e.g., sealed enclosure 108).

[0044] Figure 2A shows an inflatable penile prosthesis 200 having an electronic pump assembly 206 according to an embodiment. Figure 2B shows an example 210 of a sealed fluid chamber of the electronic pump assembly 206 according to an embodiment. The inflatable penile prosthesis 200 in Figures 2A and 2B can be an example of the inflatable penile prosthesis 100 of Figure 1 and may include any of the details discussed with reference to Figure 1.

[0045] The inflatable penile prosthesis 200 includes a fluid reservoir 202, an inflatable member 204, and an electronic pump assembly 206 configured to transfer fluid between the fluid reservoir 202 and the inflatable member 204. The electronic pump assembly 206 can automatically transfer fluid between the fluid reservoir 202 and the inflatable member 204 without the user manually operating the pump (e.g., by squeezing and releasing the pump spherical body). The electronic pump assembly 206 includes a sealed enclosure 208 that encloses the components of the electronic pump assembly 206. The sealed enclosure 208 can be an airtight (or substantially airtight) metal-based container. In some examples, the sealed enclosure 208 is a titanium container. In some examples, titanium is the only material in contact with the patient.

[0046] The electronic pump assembly 206 includes an active valve 218, pumps 220-1 and 220-2, a pressure sensor 230, a driver 236 for driving the active valve 218, pumps 220-1 and 220-2, and a battery 216 (and other electrical components) for powering the controller 214. In some examples, the battery 216 is a non-rechargeable battery. In some examples, the battery 216 is a rechargeable battery. In some examples, the electronic pump assembly 206 (or a portion thereof) is configured to connect to an external charger 234 for charging the battery 216. In some examples, the controller 214 may include a charging interface 232 configured to connect to the external charger 234. In some examples, the charging technology may be electromagnetic or piezoelectric.

[0047] The electronic pump assembly 206 may include an antenna 212 configured to wirelessly transmit (and receive) wireless signals to an external device 201. In some examples, the external device 201 is a smartphone, as shown in Figure 2A. However, the external device 201 may be any type of component that can communicate with the electronic pump assembly 206, such as a computer (laptop or desktop), tablet, pendant, or key fob. The user can control the inflatable penile prosthesis 200 using the external device 201. The electronic pump assembly 206 may include a penetration 240 through a sealed enclosure 208 to receive / transmit wireless signals through the antenna 212. For example, the antenna 212 may be connected to a controller 214 (e.g., through one or more wired connection lines), and the wired connection lines extend through the penetration 240. The external device 201 can communicate with the controller 214 over a network. In some examples, the network includes short-range wireless networks such as Near Field Communication (NFC), Bluetooth, or infrared communication. In some examples, the network may include the Internet (e.g., Wi-Fi) and / or other types of data networks, such as local area networks (LANs), wide area networks (WANs), cellular networks, satellite networks, or other types of data networks.

[0048] The controller 214 can be any type of controller configured to control the operation of pumps 220-1, 220-2, and the active valve 218. In some examples, the electronic pump assembly 206 includes one or more drivers 236 configured to drive pumps 220-1, 220-2, and the active valve 218 based on control signals generated by the controller 214.

[0049] The electronic pump assembly 206 may include a sealed fluid chamber 210 located inside the sealed enclosure 208. The sealed fluid chamber 210 may be a separate, airtight (or substantially airtight) container within the sealed enclosure 208. The sealed fluid chamber 210 may include one or more metal-based materials. In some examples, the sealed fluid chamber 210 is a titanium container. The sealed fluid chamber 210 can isolate the fluid from electronic equipment (e.g., controller 214, driver 236, battery 216, etc.). In other words, the electronic equipment section can be completely isolated from the fluid by the sealed fluid chamber 210. The sealed fluid chamber 210 may be fluidically connected to a fluid reservoir 202 and an inflatable member 204. The sealed fluid chamber 210 may include an active valve 218, a pump 220-1, and a pressure sensor 230.

[0050] The sealed fluid chamber 210 has a controller 214, a driver 236, and a through-hole 238 (e.g., a sealed through-hole, an electrical through-hole, a through-hole connector, etc.) to the driver 236 and / or controller 214 for exchanging signals with components contained within the sealed fluid chamber 210, such as an active valve 218, pumps 220-1 and 220-2, and a pressure sensor 230. In some examples, the driver 236 (and / or controller 214) is connected through one or more wired connection lines extending through the through-hole 238 to the active valve 218, pumps 220-1 and 220-2, and the pressure sensor 230. In some examples, the sealed fluid chamber 210, placed within a sealed enclosure 208, creates a double-sealed system. In some examples, the electronic pump assembly 206 contains only one sealed enclosure (e.g., sealed enclosure 208).

[0051] Pump 220-1 may include an inlet and an outlet. The inlet of pump 220-1 can be fluidically connected to the fluid reservoir 202, and the outlet of pump 220-1 can be fluidically connected to the inflatable member 204. Pump 220-1 may include an inlet and an outlet. The inlet of pump 220-2 can be fluidically connected to the fluid reservoir 202, and the outlet of pump 220-2 can be fluidically connected to the inflatable member 204. Active valve 218 may include an inlet and an outlet. The inlet of active valve 218 can be fluidically connected to the inflatable member 204, and the outlet of active valve 218 can be fluidically connected to the fluid reservoir 202.

[0052] Pumps 220-1 and 220-2 are electronically controlled pumps. Pumps 220-1 and 220-2 can be electronically controlled by controller 114. For example, each of pumps 220-1 and 220-2 can be connected to driver 236 and / or controller 214 to receive control (drive) signals. In some examples, pumps 220-1 and 220-2 are unidirectional, capable of transferring fluid from fluid reservoir 202 to inflatable member 204. However, in some examples, pumps 220-1 and 220-2 are bidirectional. In some examples, pump 220-1 or pump 220-2 is an electromagnetic pump that moves fluid between fluid reservoir 202 and inflatable member 204 using electromagnetics. With respect to an electromagnetic pump, the magnetic field is set at a certain angle with respect to the direction in which the fluid moves, and an electric current is passed through it.

[0053] In some examples, pump 220-1 or pump 220-2 is a piezoelectric pump. In some examples, the piezoelectric pump may be a diaphragm micropump that uses the actuation of a diaphragm to drive a fluid. In some examples, the piezoelectric pump may include one or more piezoelectric pumps (e.g., piezoelectric elements) that can be implemented by a substrate layer of high-voltage piezoelectric elements (e.g., a single substrate layer) or by multiple substrate layers of low-voltage piezoelectric elements (e.g., a multilayer substrate layer). In some examples, pump 220-1 or pump 220-2 includes multiple micropumps (e.g., piezoelectric-driven micropumps) arranged on one or more substrates (e.g., wafers). In some examples, the micropumps include a silicon-based material. In some examples, the micropumps include a metal (e.g., steel)-based material. In some examples, pump 220-1 or pump 220-2 is non-mechanical (e.g., has no moving parts).

[0054] Pump 220-1 or pump 220-2 may include passive check valves 223 and 225. Passive check valves 223 and 225 can help maintain pressure within the inflatable member 204. Pump 220-1 may be placed in parallel with the active valve 218. Pump 220-2 may be placed in parallel with pump 220-1. In some examples, the use of two parallel pumps (e.g., pump 220-1 and pump 220-2) can increase the amount of fluid that can be transferred to the inflatable member 204. In some examples, pumps 220-1 and 220-2 may be operated out of phase with each other to increase the efficiency of the electronic pump assembly 206. In some cases, two parallel pumps (e.g., pump 220-1, pump 220-2) operating out of phase (e.g., 180-degree phase difference) can allow the output pressure of pump 220-1 to improve valve closure of pump 220-2, thereby improving overall performance (and vice versa). In some cases, the use of parallel pumps operating out of phase (e.g., pump 220-1, pump 220-2) can allow pumps 220-1 and 220-2 to operate at a lower frequency, thereby reducing power consumption (and thus extending battery life). Furthermore, a smoother flow rate can be achieved, resulting in less vibration and an improved patient experience.

[0055] The active valve 218 can be an electronically controlled valve. The active valve 218 can be electronically controlled by a controller 214. For example, the active valve 218 can be connected to a driver 236 (and / or controller 214) and the active valve 218 can receive signals to shift the active valve 218 between an open position through which fluid flows and a closed position through which fluid is prevented from flowing through the active valve. In some examples, the active valve 218 can be moved to the closed position to maintain (e.g., substantially maintain) the pressure in the inflatable member 204. In some examples, the active valve 218 can be moved to the open position to release the pressure in the inflatable member 204 and / or to allow backflow into the inflatable member 204 in order to transfer and return the fluid to the fluid reservoir 202. In some examples, the active valve 218 can be used to maintain (e.g., substantially maintain) a partial expansion pressure.

[0056] The pressure sensor 230 is configured to measure the pressure of the inflatable member 204. The pressure sensor 230 can be coupled to a portion of the fluid passage connected to the inflatable member 204. In some examples, the pressure sensor 230 can be coupled to a portion of the fluid passage that is between the active valve 218 and the inflatable member 204. In some examples, the pressure sensor 230 can be coupled to a portion of the fluid passage that is between the pump 220-1 and the inflatable member 204. In some examples, the pressure sensor 230 can be coupled to a portion of the fluid passage that is between the pump 220-2 and the inflatable member 204. The pressure sensor 230 is communicatively coupled to the controller 214 so that the controller 214 can receive signals from the pressure sensor 230. The controller 214 receives the measured pressure from the pressure sensor 230 and can automatically control the active valve 218, pump 220-1, and pump 220-2. For example, if the measured pressure is lower than the target expansion pressure, the controller 214 can activate pumps 220-1 and 220-2 to pump additional fluid into the expandable member 204.

[0057] Figure 3 illustrates an example of a portion of the electronic pump assembly 306 according to its configuration. The electronic pump assembly 306 may be an example of the electronic pump assembly 106 in Figure 1 and / or the electronic pump assembly 206 in Figures 2A and 2B, and may include any of the details discussed with reference to the inflatable penile prosthesis 100 in Figure 1 and / or the inflatable penile prosthesis 200 in Figures 2A and 2B.

[0058] The electronic pump assembly 306 is configured to transfer fluid between the fluid reservoir 302 and the inflatable member 304. The electronic pump assembly 306 can automatically transfer fluid between the fluid reservoir 302 and the inflatable member 304 without the user having to manually operate the pump (e.g., by crushing and releasing the pump spherical body).

[0059] The electronic pump assembly 306 includes a pump 320-1 located in a fluid passage 327 (e.g., a filling passage) and an active valve 318 located in a fluid passage 324 (e.g., a discharge passage). Pump 320-1 may be an electromagnetic pump or a piezoelectric pump. Pump 320-1 may include a passive check valve 323 and a passive check valve 325. Fluid passage 327 may be a separate (and parallel) fluid branch from fluid passage 324. Fluid passage 327 is a passage that transfers fluid from the fluid reservoir 302 to the inflatable member 304. Fluid passage 324 is a passage that transfers fluid from the inflatable member 304 to the fluid reservoir 302. Pump 320-1 is located in parallel with the active valve 318.

[0060] In some examples, the electronic pump assembly 306 may include an active valve 319 in series with pump 320-1 (for example, pump 320-1 and active valve 319 are located in a fluid passage 327). In some examples, the electronic pump assembly 306 may include pump 320-2 in series with active valve 318 (for example, pump 320-2 and active valve 318 are located in a fluid passage 324). Pump 320-2 may be an electromagnetic pump or a piezoelectric pump. Pump 320-2 may include a passive check valve 323 and a passive check valve 325. In some examples, the electronic pump assembly 306 may include an active valve 348 fluidly connected to a fluid reservoir 302. Active valve 348 may be in series with either active valve 318 (and pump 320-2) or pump 320-1 (and active valve 319). In some examples, the electronic pump assembly 306 includes an active valve 352 that is fluidly connected to the inflatable member 304. The active valve 352 may be connected in series with either the active valve 319 (and pump 320-1) or the pump 320-2 (and active valve 318).

[0061] The active valve 348, pump 320-1, active valve 318, active valve 352, active valve 318, and pump 320-2 can be electronically controlled by a controller and / or driver (e.g., controller 114 in Figure 1, controller 214 and driver 236 in Figures 2A and 2B). Pumps 320-1 and 320-2 can be unidirectional or bidirectional. With respect to the fluid passage 327, in some examples, pump 320-1 and active valve 319 can be swapped (e.g., in this case, active valve 319 is in series between active valve 348 and pump 320-1). With respect to the fluid passage 324, in some examples, active valve 318 and pump 320-2 can be swapped (e.g., in this case, pump 320-1 is in series between active valve 318 and active valve 348).

[0062] In some examples, one or more additional active valves and / or one or more additional pumps are arranged in series within the fluid passage 327. In some examples, one or more additional active valves and / or one or more additional pumps are arranged in series within the fluid passage 324. In some examples, the electronic pump assembly 306 may include one or more additional (and parallel) fluid passages, in which case each additional (and parallel) fluid passage may include one or more active valves and one or more pumps.

[0063] In some examples, the electronic pump assembly 306 may include pressure sensors 330 and 331. Pressure sensors 330 and 331 are connected to a controller (for example, controller 114 in Figure 1, controller 214 in Figures 2A and 2B), which receives the measured pressure from pressure sensors 330 and 331.

[0064] The pressure sensor 330 is configured to measure the pressure within the inflatable member 304. The controller can receive the measured pressure from the pressure sensor 330 and automatically control the active valve and / or pump to adjust the pressure. In some examples, the pressure sensor 331 is configured to measure the pressure within the fluid reservoir 302. In some examples, the pressure sensor 331 can detect intra-abdominal pressure (which may increase during activities such as exercise), and the controller can control the active valve and pump to minimize or prevent accidental inflation. In some examples, the electronic pump assembly 306 may include one or more pressure sensors elsewhere inside it. For example, the pressure sensor may be located between the active valve 348 and the pump 320-1. In some examples, the pressure sensor may be located between the pump 320-1 and the active valve 319. In some examples, the pressure sensor may be located between the active valve 348 and the active valve 318. In some examples, the pressure sensor may be located between the active valve 318 and the pump 320-2. In some examples, the pressure sensor can be positioned between the expandable member 304 and the active valve 352.

[0065] Figure 4 schematically illustrates an inflatable penile prosthesis 400 having an electronic pump assembly 406 according to its embodiment. The electronic pump assembly 406 may include any of the features of the electronic pump assemblies (e.g., 106, 206, 306) and inflatable penile prostheses (e.g., 100, 200) discussed herein. The inflatable penile prosthesis 400 may include a pair of inflatable cylinders 410, which are configured to be embedded in the penis. For example, one inflatable cylinder 410 may be positioned on one side of the penis, and the other inflatable cylinder 410 may be positioned on the other side of the penis. Each inflatable cylinder 410 may include a first terminal portion 424, a cavity or inflation chamber 422, and a second terminal portion 428 having a posterior tip 432.

[0066] At least a portion of the electronic pump assembly 406 can be implanted in the patient's body. A pair of conduit connectors 405 can be used to attach the electronic pump assembly 406 to the inflatable cylinder 410 so that the electronic pump assembly 406 is in fluid communication with the inflatable cylinder 410. Similarly, the electronic pump assembly 406 can be in fluid communication with the fluid reservoir 450 through the conduit connector 403. The fluid reservoir 450 can be implanted in the user's abdomen. The inflation chamber 422 of the inflatable cylinder 410 can be placed inside the penis. The first terminal portion 424 of the inflatable cylinder 410 can be placed at least partially inside the glans portion of the penis. The second terminal portion 428 can be implanted in the patient's pubic region PR with its posterior tip 432 close to the pubic bone PB.

[0067] To implant the inflatable cylinder 410, the surgeon first prepares the patient. In many cases, the surgeon creates an incision in the penoscrotal region, for example, where the base of the penis meets the upper part of the scrotum. The surgeon can expand the patient's corpus cavernosum from the penoscrotal incision to prepare the patient to receive the inflatable cylinder 410. This corpus cavernosum is the one of two parallel columns of erectile tissue that form the dorsal part of the body of the penis, for example, two elongated columns that extend substantially the entire length of the penis. The surgeon will also expand two areas of the pubic region to prepare the patient to receive the second distal portion 428. The surgeon can measure the length of the corpus cavernosum from the incision and the length of the expanded area of ​​the pubic region to determine the appropriate size of the inflatable cylinder 410 to be implanted.

[0068] After the patient is ready, the inflatable penile prosthesis 400 is implanted in the patient. The tip of the first terminal portion 424 of each inflatable cylinder 410 can be connected to a suture. The other end of the suture can be connected to a needle member (e.g., a Keith needle). The needle member is inserted into the incision and into the corpus cavernosum. The needle member is then pushed through the glans of the penis. The surgeon pulls the suture to draw the inflatable cylinder 410 into the corpus cavernosum. This draw-in is performed for each inflatable cylinder 410 that makes up a pair. Once the inflation chamber 422 is in position, the surgeon can remove the suture from the tip. The surgeon then inserts the second terminal portion 428. The surgeon inserts the posterior end of the inflatable cylinder 410 into the incision and pushes the second terminal portion 428 toward the pubic bone until each inflatable cylinder 410 is in position.

[0069] The user can control the inflatable penile prosthesis 400 using an external device 401. In some examples, the user can inflate or deflate the inflatable cylinder 410 using the external device 401. For example, in response to the user initiating an inflation cycle using the external device 401, the external device 401 can send a radio signal to the electronic pump assembly 406 to initiate the inflation cycle and transfer fluid from the fluid reservoir 450 to the inflatable cylinder 410. In some examples, in response to the user initiating a deflation cycle using the external device 401, the external device 401 can send a radio signal to the electronic pump assembly 406 to initiate the deflation cycle and transfer fluid from the inflatable cylinder 410 to the fluid reservoir 450. In some examples, the fluid is transferred and returned during the deflation cycle until the pressure inside the inflatable cylinder 410 reaches a partial inflation pressure.

[0070] Figure 5 illustrates flowchart 500, which shows an exemplary operation of an electronic pump assembly of an inflatable penile prosthesis. The exemplary operation of flowchart 500 can be performed by any of the inflatable penile prostheses (e.g., 100, 200, 400) and / or electronic pump assemblies (e.g., 106, 206, 306, 406) discussed herein.

[0071] Actuation 502 includes the step of receiving a radio control signal from an external device via the antenna of the electronic pump assembly. Actuation 504 includes the step of generating a first control signal by the controller to control the active valve of the electronic pump assembly. Actuation 506 includes the step of generating a second control signal by the controller to control the pump of the electronic pump assembly. Actuation 508 includes the step of operating the active valve to the closed position in response to the first control signal. Actuation 510 includes the step of operating the pump in response to the second control signal to transfer fluid from the fluid reservoir to the inflatable member until the pressure in the inflatable member reaches a threshold level. In some examples, the actuation may include the step of generating a third control signal by the controller to control the active valve. In some examples, the actuation may include the step of operating the active valve to the open position in response to the third control signal to transfer at least a portion of the fluid from the inflatable member to the fluid reservoir.

[0072] Detailed descriptions have been discussed herein. However, it should be understood that the embodiments disclosed herein are merely examples of how the invention can be embodied in various forms. Accordingly, the specific structural and functional details discussed herein should not be construed as limiting, but rather as representative grounds for the claims and for teaching those skilled in the art how to adapt these embodiments to virtually any suitable detailed structure. Furthermore, the terms and phrases used herein are not limiting and are intended to provide an understandable description of the disclosure of the invention.

[0073] As used herein, the terms "a" and "an" are defined as one or more than one. As used herein, the term "another" is defined as at least two or three or more. As used herein, the terms "including" and / or "having" are defined as comprising (i.e., open transition). As used herein, the terms "combined" or "movably combined" are defined as a connection, although not necessarily direct or mechanical.

[0074] Generally, the embodiments relate to bodily implants. The term patient or user may hereafter be used to refer to an individual who benefits from the medical device or method disclosed in the disclosure of the present invention. For example, a patient may be an individual in whose body an implant is made using the medical device disclosed in the disclosure of the present invention or the method disclosed to operate it. For example, in some embodiments, the patient may be a human being.

[0075] While certain features of the above-described implementation have been illustrated herein as described above, many modifications, substitutions, alterations, and equivalents will be recalled here to those skilled in the art. It will be understood that the appended claims are intended to cover all such modifications and alterations as falling within the scope of the embodiments. [Explanation of Symbols]

[0076] 100 Inflatable Penile Prostheses 102 Fluid reservoir 104 Expandable member 106 Electronic Pump Assembly 118 Active valve

Claims

1. A fluid reservoir configured to hold fluid, Expandable member and An inflatable penile prosthesis comprising an electronic pump assembly configured to transfer the fluid between the fluid reservoir and the inflatable member, The aforementioned electronic pump assembly is Pump and An active valve arranged in parallel with the pump, A controller configured to control the pump and the active valve, Includes, The aforementioned electronic pump assembly includes a sealed enclosure, The sealed enclosure includes a sealed fluid chamber, The sealed fluid chamber includes the pump and the active valve, The controller is an inflatable penile prosthesis located inside the sealed enclosure but outside the sealed fluid chamber.

2. The inflatable penile prosthesis according to claim 1, wherein the pump includes an electromagnetic pump, or the pump includes a piezoelectric pump.

3. The inflatable penile prosthesis according to claim 1, wherein the electronic pump assembly includes an antenna configured to receive wireless control signals from an external device, and the controller is configured to control at least one of the pump or the active valve based on the wireless control signals.

4. The inflatable penile prosthesis according to claim 1, wherein the pump is a first pump, and the electronic pump assembly includes a second pump.

5. The inflatable penile prosthesis according to claim 4, wherein the second pump is arranged in parallel with the first pump.

6. The inflatable penile prosthesis according to claim 5, wherein the second pump is configured to operate in phase with respect to the first pump.

7. The inflatable penile prosthesis according to claim 4, wherein the second pump is arranged in series with the first pump.

8. The pump includes one or more passive check valves and / or The active valve is configured to transition between an open position in which the fluid flows through the active valve and a closed position in which the fluid is prevented from flowing through the active valve, and / or The electronic pump assembly includes a pressure sensor connected to the inflatable member or the fluid reservoir, and the controller is configured to control at least one of the pump or the active valve based on the pressure measured by the pressure sensor, and / or The inflatable penile prosthesis according to claim 1, wherein the active valve is a first active valve, and the electronic pump assembly includes a second active valve arranged in series with the pump.

9. A fluid reservoir configured to hold fluid, Expandable member and An inflatable penile prosthesis comprising an electronic pump assembly configured to transfer the fluid between the fluid reservoir and the inflatable member, The aforementioned electronic pump assembly is The first pump and The second pump, Active valve, A controller configured to control the first pump, the second pump, and the active valve, Includes, The aforementioned electronic pump assembly includes a sealed enclosure, The sealed enclosure includes a sealed fluid chamber, The sealed fluid chamber includes the first pump, the second pump, and the active valve. The controller is an inflatable penile prosthesis located inside the sealed enclosure but outside the sealed fluid chamber.

10. The inflatable penile prosthesis according to claim 9, wherein the first pump and the active valve are in parallel with each other.

11. The inflatable penile prosthesis according to claim 9, wherein the active valve is configured to transition between an open position in which the fluid flows through the active valve and a closed position in which the fluid is prevented from flowing through the active valve.

12. The aforementioned electronic pump assembly includes a pressure sensor, The inflatable penile prosthesis according to claim 9, wherein the controller is configured to control at least one of the first pump, the second pump, or the active valve based on the pressure measured by the pressure sensor.

13. The inflatable penile prosthesis according to claim 12, wherein the pressure sensor is connected to the inflatable member or the fluid reservoir.

14. The inflatable penile prosthesis according to claim 9, wherein the active valve is a first active valve arranged in parallel with the first pump, and the electronic pump assembly includes a second active valve arranged in parallel with the second pump.

15. The inflatable penile prosthesis according to claim 14, wherein the second active valve is arranged in series with the first pump.

16. A method for operating an inflatable penile prosthesis comprising a fluid reservoir configured to hold a fluid, an inflatable member, and an electronic pump assembly configured to transfer the fluid between the fluid reservoir and the inflatable member, The electronic pump assembly controller receives wireless control signals from an external device via the electronic pump assembly's antenna. The controller generates a first control signal for controlling the active valve of the electronic pump assembly, The controller generates a second control signal for controlling the pump of the electronic pump assembly, wherein the active valve is arranged in parallel with the pump. The controller, in response to the first control signal, operates the active valve to the closed position, The controller, in response to the second control signal, operates the pump to transfer fluid from the fluid reservoir to the inflatable member until the pressure within the inflatable member reaches a threshold level. Includes, The aforementioned electronic pump assembly includes a sealed enclosure, The sealed enclosure includes a sealed fluid chamber, The sealed fluid chamber includes the pump and the active valve, The controller is located inside the sealed enclosure but outside the sealed fluid chamber.

17. The controller generates a third control signal for controlling the active valve, The controller, in response to the third control signal, operates the active valve to the open position so as to transfer at least a portion of the fluid from the expandable member to the fluid reservoir; The method according to claim 16, further comprising:

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