Electronically implantable penile prosthesis with pressure adjustment and other functions

Abstract

According to an embodiment, an 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), a pressure sensor (130) configured to measure pressure in the inflatable member, and a controller (114) configured to control at least one of the pump or the active valve based on the measured pressure.

Description

Technical Field

[0001] 〔Cross - Reference to Related Applications〕 This application is a continuation of and claims priority to U.S. Non - Provisional Application No. 18 / 068,108, filed on December 19, 2022, titled "ELECTRONIC IMPLANTABLE PENILE PROSTHESIS WITH PRESSURE REGULATION AND OTHER FUNCTIONS", which claims priority to U.S. Provisional Patent Application No. 63 / 265,812, filed on December 21, 2021, titled "ELECTRONIC IMPLANTABLE PENILE PROSTHESIS WITH PRESSURE REGULATION AND OTHER FUNCTIONS", the disclosure of which is hereby incorporated by reference in its entirety.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 265,812, filed on December 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 with pressure regulation and other functions.

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 compressed by the user to move fluid from a reservoir into the cylinders to cause an erection. For some patients, the manual pumping procedure can be relatively difficult. [Overview of the project] [Means for solving the problem]

[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, a pressure sensor configured to measure the pressure in the inflatable member, and a controller configured to control at least one of the pump or the active valve based on the measured pressure.

[0006] In some embodiments, an inflatable penile prosthesis may include one or more (or any combination thereof) of the following features: A controller is configured to open an active valve in response to a measured pressure being above a threshold, thereby transferring a portion of the fluid from the inflatable member to a fluid reservoir. A controller is configured to activate a pump in response to a measured pressure being below a threshold, thereby transferring a portion of the fluid from the fluid reservoir to the inflatable member. The fluid reservoir includes a pressure-regulating flexible member configured to partially inflate the inflatable member without activating the pump. An electronic pump assembly includes an accelerometer configured to measure the user's acceleration of the inflatable penile prosthesis. A controller is configured to identify the user's sleep pattern based on the measured acceleration, and the controller is configured to at least partially inflate the inflatable member when the user is sleeping. An electronic pump assembly includes a heart rate sensor configured to monitor the user's heart rate of the inflatable penile prosthesis. An electronic pump assembly includes a temperature sensor configured to measure the temperature of the fluid. The controller is configured to repeatedly initiate expansion and contraction cycles during the period, with each subsequent iteration increasing the pressure within the expandable member.

[0007] 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 an antenna configured to receive radio signals from an external device, a pump, an active valve, a pressure sensor configured to measure the pressure of the inflatable member, and a controller configured to control at least one of the pump or the active valve based on at least one of the measured pressure or the radio signal.

[0008] In some embodiments, an inflatable penile prosthesis may include one or more (or any combination thereof) of the following features: An electronic pump assembly includes an accelerometer configured to measure the acceleration of the user of the inflatable penile prosthesis. A controller is configured to determine the type of activity based on the measured acceleration, and the controller is configured to adjust the pressure sensing rate associated with a pressure sensor based on the type of activity. The controller is configured to partially inflate the inflatable member so that the pressure of the inflatable member does not exceed a threshold, and in response to a radio signal, the controller is configured to inflate the inflatable member to a maximum pressure threshold during the inflation cycle. The electronic pump assembly includes a temperature sensor configured to measure the temperature of a fluid, and in response to the measured temperature being higher than a threshold, the controller is configured to send a notification message to one or more external devices via an antenna on a network. The controller includes a memory configured to store at least one of a maximum pressure threshold or a partial pressure threshold, and the controller is configured to update the value of at least one of the maximum pressure threshold or partial pressure threshold based on information received from an external device via an antenna. The controller is configured to detect performance problems associated with an inflatable penile prosthesis based on pressure readings from a pressure sensor, and is configured to send notification messages over a network to one or more external devices in response to the detection of a performance problem. The electronic pump assembly includes a battery configured to power the controller, and the electronic pump assembly includes a sensor configured to monitor the battery's performance. The controller is configured to acquire pressure readings from the pressure sensor over time according to a pressure sensor rate, and is configured to detect a first pressure pulsation at a first time and a second pressure pulsation at a second time, and is configured to open the active valve after the first time and close the active valve before the second time. The electronic pump assembly includes a check valve in series with the pump.

[0009] Depending on the embodiment, a method for operating an inflatable penile prosthesis includes the steps of: receiving a radio control signal from an external device via the antenna of an electronic pump assembly; initiating the pump of the electronic pump assembly via a controller to operate in response to the radio control signal to transfer fluid from a fluid reservoir to the inflatable member so that the pressure of the inflatable member reaches a threshold; measuring the pressure of the inflatable member via a pressure sensor; and initiating the active valve of the electronic pump assembly to the open position in response to the measured pressure being higher than a threshold, in order to transfer a portion of the fluid from the inflatable member to the fluid reservoir. In some examples, the method includes the step of the controller detecting that the measured pressure corresponds to a threshold. In some examples, the method includes the step of the controller activating the active valve to the closed position in response to the detection that the measured pressure corresponds to a threshold. [Brief explanation of the drawing]

[0010] [Figure 1A] This figure shows an inflatable penile prosthesis having an electronic pump assembly according to its configuration. [Figure 1B] This figure shows a controller for 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 diagram shows a check valve in series with the pump in an electronic pump assembly according to its configuration. [Figure 2C] This figure shows a check valve in series with the pump in an electronic pump assembly according to another embodiment. [Figure 3] This figure shows an example of an electronic pump assembly depending on the configuration. [Figure 4] This figure shows an example of an electronic pump assembly in a different configuration. [Figure 5] This figure shows an inflatable penile prosthesis having an electronic pump assembly according to another embodiment. [Figure 6] This flowchart illustrates the exemplary operation of an electronic pump assembly in different configurations. [Modes for carrying out the invention]

[0011] The present invention discloses 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). The electronic pump assembly may include a primary battery (e.g., a non-rechargeable battery) or a rechargeable battery configured to be recharged by an external charger.

[0012] An electronic pump assembly includes one or more pumps (e.g., one or more electronically controlled pumps such as electromagnetic or piezoelectric pumps), one or more active valves, and a controller. In some examples, the electronic pump assembly includes an accelerometer, a heart rate monitor, and one or more sensors for monitoring the battery or other electronic equipment on the electronic pump assembly. In some examples, the electronic pump assembly includes a temperature sensor.

[0013] The controller can control the expansion and contraction of the inflatable member by operating the pump and active valve based on control signals transmitted to the pump and active valve. The pump can be unidirectional or bidirectional. In some examples, the electronic pump assembly includes one or more pumps in parallel with the active valve. In some examples, the pump can transport fluid to the inflatable member during the expansion cycle, and the active valve can move to an open position during the contraction cycle, allowing the fluid to return to the fluid reservoir. The pump can transport fluid to the inflatable member at a relatively high pressure speed or pressure rate on demand. In some examples, the electronic pump assembly includes two or more parallel pumps, such as a first pump and a second pump, in which case the first and second pumps are configured to operate in phases out of each other, thereby increasing the efficiency of the pumping operation. In some examples, the use of parallel pumps operating in different phases can allow the pumps to operate at a low frequency, thereby reducing power consumption and improving battery life. In some examples, the 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. In some examples, the electronic pump assembly may include one or more pumps (e.g., discharge pumps) in series with the active valve. In some examples, the electronic pump assembly may include a check valve in series with one or more pumps (e.g., filling pumps).

[0014] 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 hold (e.g., substantially hold) 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 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 or in parallel with the pump.

[0015] The electronic pump assembly may include a pressure sensor configured to sense the pressure of 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 may automatically control an active valve and / or pump to receive the measured pressure from the pressure sensor and adjust the pressure within the inflatable member.

[0016] For example, an electronic pump assembly can receive a wireless signal from an external device. The wireless signal can cause a controller to initiate an expansion cycle that transfers fluid from a fluid reservoir to an expandable member so that the pressure in the expandable member reaches a threshold. To initiate the expansion cycle, the controller can activate an active valve to the closed position and activate one (or more) pumps to move fluid to the expandable member until the pressure in the expandable member reaches a threshold.

[0017] The controller and the pressure sensor can adjust the pressure of the inflatable member (e.g., during sexual activity). For example, in the case of compression of the inflatable member, a pressure increase (or spike) may occur. However, the pressure adjustment discussed herein can minimize or prevent damage to the patient or damage to the device. For example, the controller can receive a pressure reading from the pressure sensor and, in response to the measured pressure being higher than a threshold (or higher than the threshold for a period), place the active valve in the open position to return a portion of the fluid from the inflatable member to the fluid reservoir. In response to the measured pressure corresponding to the threshold (or being lower than the threshold), the controller can switch the active valve to the closed position.

[0018] Similarly, there may be a small amount of leakage through the pump, passive valve, and active valve, and this leakage may increase during higher pressure increases during sexual activity. However, in response to the measured pressure being lower than the target threshold, the controller can activate the pump to transfer additional fluid to the inflatable member so that the target pressure can be reached.

[0019] In some examples, when the inflatable member is inflated to its target pressure (e.g., during sexual activity), the controller can increase the pressure sensing speed or rate at which it receives pressure readings (e.g., during sexual activity, the pressure is measured at high intervals). When the inflatable member is not inflated to its target pressure, the controller can reduce the pressure sensing speed to conserve power and battery energy. These pressure adjustment operations and other enhanced operations of the inflatable penile prosthesis will be described in more detail with reference to the figures.

[0020] Figure 1A shows an inflatable penile prosthesis 100 according to an embodiment, the prosthesis 100 having an electronic pump assembly 106 that can improve its performance. Figure 1B illustrates an example of a controller 114 for the electronic pump assembly 106 according to an embodiment. 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 embodiments, at least a portion of the electronic pump assembly 106 may be implemented in the patient's body.

[0021] 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 own rigidity. In some examples, the inflatable member 104 includes 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. The volume of fluid in each cylinder can vary from about 10 milliliters for smaller cylinders to about 70 milliliters for larger ones. In some examples, the first cylinder member may be larger than the second cylinder member. In some examples, the first cylinder member may be the same size as the second cylinder member.

[0022] The fluid reservoir 102 can include a container having an internal chamber configured to hold or contain fluid used to expand the expandable member 104. The volume capacity of the fluid reservoir 102 can vary depending on the size of the expandable penile prosthesis 100. The volume capacity of the fluid reservoir 102 can be from 3 cubic centimeters to 150 cubic centimeters. In some examples, the fluid reservoir 102 is composed of the same material as the expandable member 104. In some examples, the fluid reservoir 102 is composed of a material different from the expandable member 104. In some examples, the fluid reservoir 102 confines a larger volume of fluid than the expandable member 104.

[0023] In some examples, the fluid reservoir 102 is (or includes) a pressure-regulating flexible member 111. The pressure-regulating flexible member 111 can partially expand the expandable member 104 without activating any of the pumps 120. In some examples, the pressure-regulating flexible member 111 includes an expandable balloon. By providing a pounds per square inch (PSI) pressure level to the pressure-regulating flexible member 111, a portion of the fluid can be transferred from the fluid reservoir 102 to the expandable member. In some examples, the PSI pressure level is in the range of 1.0 PSI to 5.0 PSI. In some examples, the PSI pressure level is in the range of 2.0 PSI to 4.0 PSI. In some examples, the PSI pressure level is 3.0 PSI (or around it). During a preliminary period (e.g., before the start of the expansion cycle), the pressure of the pressure-regulating flexible member 111 can cause the transfer of fluid from the fluid reservoir 102 to the expandable member 104. In some examples, the fluid reservoir 102 is an expandable balloon. In some examples, the pressure-regulating flexible member 111 is a separate structure from the fluid reservoir 102 but is disposed inside the cavity of the fluid reservoir 102. In some examples, the pressure-regulating flexible member 111 includes an expandable balloon disposed inside the cavity of the fluid reservoir 102.

[0024] 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 transport fluid to and from the electronic pump assembly 106. The first conduit connector 103 may be coupled to the electronic pump assembly 106 and the fluid reservoir 102 so that fluid can be transported between the electronic pump assembly 106 and the fluid reservoir 102 through it. For example, the first conduit connector 103 may define a first lumen configured to transport 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 transporting fluid between the electronic pump assembly 106 and the fluid reservoir 102.

[0025] The second conduit connector 105 can be coupled to the electronic 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 it. 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.

[0026] The electronic pump assembly 106 can automatically transfer fluid between the fluid reservoir 102 and the inflatable member 104 without the user having to manually operate the pump (e.g., by crushing and releasing the pump spherical body). 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 pumps 120 to pump fluid between the fluid reservoir 102 and the inflatable member 104. The controller 114 can control the active valves 118 to move between open and closed positions. The pumps 120 are configured to transfer fluid to the inflatable member 104 at a relatively high pressure (e.g., up to about 20.0 PSI) (on demand).

[0027] The electronic pump assembly 106 may include a battery 116 configured to power 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 connect to an external charger to charge the battery 116. In some examples, the electronic pump assembly 106 defines a charging interface configured to connect to (or be located around) an external charger. In some examples, the charging interface includes a Universal Serial Bus (USB) interface configured to accept a USB charger. In some examples, the charging technology is electromagnetic or piezoelectric.

[0028] The electronic pump assembly 106 may include an antenna 112 configured to wirelessly transmit (and receive from) a wireless signal 109 to one external device 101 (or more external devices 101). The external device 101 can be any type of component that can communicate with the electronic pump assembly 106. The external device 101 can be a computer, smartphone, tablet, pendant, key fob, etc. In the example, the external device 101 includes one or more devices associated with the user of the inflatable penile prosthesis and one or more devices associated with the physician. In some examples, the external device 101 includes a server computer configured to receive data over a network. In some examples, the external device 101 includes an application 117 that can be run by its operating system or browser. The application 117 may define one or more user interfaces that allow the user to control the inflatable penile prosthesis 100 and set (or update) more settings or control parameters associated with the inflatable penile prosthesis 100.

[0029] The user can control the inflatable penile prosthesis 100 using an external device 101. The user can inflate or deflate the inflatable member 104 using the external device 101. For example, in response to the user initiating an inflation cycle using the external device 101 (e.g., by 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 inflation cycle, and the controller 114 can control the active valve 118 and pump 120 to inflate the inflatable member 104 to a target inflation pressure which can be up to a maximum pressure threshold 160-1 (determined by the physician) or a maximum pressure threshold 160-2 (determined by the patient). The controller 114 can close the active valve and activate the pump to move fluid from the fluid reservoir 102 to the inflatable member 104. The controller 114 can operate the pump 120 according to the pump frequency. In some examples, the pumping architecture is designed so that acoustic frequencies are minimized or avoided. The frequency range from 50 Hz to 19 kHz is perceptible to humans. Controller 114 can operate pump 120 according to a pump frequency of 50 Hz or less. In some examples, controller 114 operates pump 120 according to a pump frequency of 40 Hz or less. In some examples, controller 114 operates pump 120 according to a pump frequency of 30 Hz or less.

[0030] The maximum pressure threshold 160-1 can be determined by a physician and is the maximum allowable inflation pressure of the inflatable member 104. In some cases, the maximum pressure threshold 160-1 is programmed in the controller 114 (and can be adjusted using an external device 101 to update the value stored in the controller 114). The maximum pressure threshold 160-2 can be determined by the patient and is lower than (or within the range of) the maximum pressure threshold 160-1. For example, if the maximum pressure threshold 160-1 is 20.0 PSI, the maximum pressure threshold 160-2 can be 20.0 PSI or less (but not exceeding 20.0 PSI). In some cases, the maximum pressure threshold 160-2 is programmed in the controller 114 (and can be adjusted using an external device 101 to update the value stored in the controller 114).

[0031] In response to a user initiating a deflation cycle using an external device 101 (for example, by selecting a user controller on the external device 101), the external device 101 can transmit a radio signal 109 (received via 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, pumps 120-3) 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 cases, during the deflation cycle, the fluid is sent back until the pressure in the inflatable member 104 reaches a partial deflation threshold 162-1 (determined by the physician) or a partial deflation threshold 162-2 (determined by the patient). In some cases, the controller 114 can automatically decide to initiate the deflation cycle, and as a result, the controller 114 controls the active valve 118 (and in some cases, the pump 120-3) to send the fluid back to the fluid reservoir 102.

[0032] The partial inflation pressure (e.g., partial inflation threshold 162-1, partial inflation threshold 162-2) is a pressure threshold that can more faithfully simulate the user's natural sensation and / or personal comfort. The partial inflation threshold 162-1 can be determined by a physician and, in some cases, is the inflation pressure at the end of a contraction cycle. In some cases, the partial inflation pressure is in the range of 0.5 PSI to 6.0 PSI. In some cases, the inflatable penile prosthesis 100 does not include a partial inflation threshold (162-1 or 162-2), in which case the pressure in the inflatable member 104 at the end of a contraction cycle is around zero PSI. In some cases, the partial inflation threshold (162-1 or 162-2) is optional and selectable by the user (e.g., using an external device 101). In some cases, the partial inflation threshold 162-1 is programmed in the controller 114 (and can be adjusted using the external device 101 to update the value stored in the controller 114). The partial inflation threshold 162-2 can be determined by the patient and is lower than (or within the range of) the partial inflation threshold 162-1. For example, if the partial inflation threshold 162-1 is 5.0 PSI, the partial inflation threshold 162-2 can be 5.0 PSI or less. In some cases, the partial inflation threshold 162-2 is programmed in the controller 114 (and can be adjusted using an external device 101 to update the value stored in the controller 114).

[0033] The controller 114 can reduce the pressure 172 of the inflatable member 104 to a value lower than a partial expansion threshold (e.g., 162-1, 162-2) (or target pressure) in response to receiving a control signal (e.g., a radio signal 109) received through the antenna 112. For example, a patient may have difficulty urinating when the inflatable member 104 is at the partial expansion threshold (e.g., 162-1, 162-2) or target pressure. In some cases, the user can send a radio signal 109 using an external device 101 to reduce the pressure 172 of the inflatable member 104 to a predetermined pressure level in preparation for urination. The controller 114 can control the active valve 118 and / or pump 120 to transfer fluid from the inflatable member 104 to reduce the pressure 172 from the partial expansion threshold (e.g., 162-1, 162-2) or target pressure to a predetermined pressure level. Subsequently, the user can select recovery control using an external device 101, which involves sending a wireless signal 109 to the controller 114 to restore the pressure 172 to a partial expansion threshold (e.g., 162-1, 162-2) or a target pressure.

[0034] The controller 114 can be any type of controller configured to control the operation of the pump 120 and the active valve 118. In some examples, the controller 114 is a microcontroller. In some examples, the controller 114 includes one or more drivers configured to drive the pump 120 and the active valve 118. In some examples, the drivers are components separate from the controller 114. The controller 114 can be communicatively coupled to the active valve 118, the pump 120, and the pressure sensor 130. In some examples, the controller 114 is connected to the active valve 118, the pump 120, and the pressure sensor 130 via wired data lines. The controller 114 may include a processor 113 and a memory device 115. The processor 113 can be formed on a substrate configured to execute one or more machine-executable instructions or parts of software, firmware, or a combination thereof. The processor 113 can be semiconductor-based, i.e., the processor may include semiconductor materials capable of executing digital logic. The memory device 115 can store information in a format that can be read and / or executed by the processor 113. The memory device 115 can store executable instructions that, when executed by the processor 113, cause the processor 113 to perform certain operations discussed herein. The controller 114 can receive data through the pressure sensor 130 and / or external device 101 and control the active valve 118 and / or pump 120 by sending control signals to them.

[0035] 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 memory device 115 can store the maximum pressure threshold 160-1, the maximum pressure threshold 160-2, the partial inflation threshold 162-1, and / or the partial inflation threshold 162-2. 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. In some examples, the controller 114 can store usage statistics 164 in the memory device 115. The usage statistics 164 may include one or more statistics regarding the usage of the inflatable penile prosthesis 100. For example, the usage statistics 164 may include the number of inflations (e.g., number of erections), the target pressure (the pressure at which the inflatable member 104 is inflated), and / or the battery status of the battery 116. In some cases, the controller 114 can periodically send usage statistics 164 to an external device 101.

[0036] 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.

[0037] 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 may include 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 parallel 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 according to a first flow rate, and pump 120-1 can transport fluid according to 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.

[0038] In some examples, pump 120 may include pump 120-3 arranged in series with active valve 118. Pump 120-3 can transfer fluid from the inflatable member 104 to the fluid reservoir 102 (for example, during a deflation cycle). For example, during a deflation cycle, controller 114 can activate active valve 118 to the open position and activate pump 120-3 to transfer fluid from the inflatable member 104 to the fluid reservoir 102. In some examples, pump 120-3 can transfer fluid according to a third flow rate. In some examples, the third flow rate is lower than the first and / or second flow rates. In some examples, the electronic pump assembly 106 may include one or more series pumps 120 and one or more parallel pumps 120. The electronic pump assembly 106 may include a fourth pump in parallel with pump 120-2, a fifth pump in parallel with the fourth 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. In some examples, one or more pumps 120 may be in series with pump 120-3.

[0039] 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. A 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, a 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, a pump 120 is either unidirectional or bidirectional. In some examples, a pump 120 includes a combination of one or more unidirectional pumps and one or more bidirectional pumps.

[0040] In some examples, the pump 120 is an electromagnetic pump that moves a fluid between a fluid reservoir 102 and an expandable member 104 using electromagnetic force. With respect to the electromagnetic pump, the magnetic field is set at a certain angle with respect to the direction in which the fluid moves and through which the current is passed.

[0041] In some examples, pump 120 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 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., without moving parts).

[0042] In some examples, when there are multiple pumps 120, each pump 120 can be of the same type (for example, all pumps 120 are either electromagnetic pumps or piezoelectric pumps). In some examples, one or more pumps 120 are different from one or more other pumps 120. For example, pumps 120 can include different types of piezoelectric pumps or different types of electromagnetic pumps. Pump 120-1 can be a piezoelectric pump having a first number of micropumps, pump 120-2 can be a piezoelectric pump having a second number of micropumps, and pump 120-3 can be a piezoelectric pump having a third number of micropumps (in this case, at least two (or all) of the first, second, and third numbers are different from or the same as each other). Pump 120-1 can be an electromagnetic pump, pump 120-2 can be a piezoelectric pump, and pump 120-3 can be an electromagnetic pump or a piezoelectric pump.

[0043] 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 (e.g., arranged in series with each other). Each passive check valve of pump 120 may be controlled based on the pressure between the inflatable member 104 and the fluid reservoir 102, rather than being directly controlled by the controller 114. 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, with respect to pumps 120-1 and 120-2, the passive check valve is biased forward to allow passive flow through the passive check valve in the direction from the fluid reservoir 102 to the inflatable member 104, and closed in the direction of flow from the inflatable member 104 to the fluid reservoir 102. In some examples, the passive check valve moves to the closed position in response to positive pressure between the inflatable member 104 and the fluid reservoir 102. In some examples, the passive check valve moves to the open position in response to negative pressure between the inflatable member 104 and the fluid reservoir 102.

[0044] 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., pumps 120-1, pumps 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 pumps 120 to operate at lower frequencies, thereby reducing power consumption (and thus extending battery life). Furthermore, with respect to smoother flow, this can result in less vibration and an improved patient experience. As shown 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.

[0045] Different phases may mean two or more control signals having a phase relationship with respect to each other such that one control signal is at its positive peak and another control signal is at (or near) its negative peak at the same time. 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 at different phases from each other. Each of the first and second control signals can define a set of activation 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 may indicate that the diaphragm element moves to a first direction, and the second state may indicate that the diaphragm element moves to 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.

[0046] 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 move the active valve 118 between an open position where fluid flows through the active valve 118 and a closed position where fluid flow is prevented. In some examples, the active valve 118 includes a diaphragm and a ring member (e.g., an O-ring). In some examples, in the closed position, the flow path is obstructed by the interface between the diaphragm and the ring member. In some examples, in the open position, the diaphragm is separated from the ring member (e.g., arranged to be spaced apart), thereby allowing fluid to flow through the active valve 118. The active valve 118 can be bidirectional. Each active valve 118 can be piezoelectrically diaphragm-actuated or electromagnetically diaphragm-actuated. In some examples, the active valve 118 is located in a fluid passage 124 used to empty an inflatable member 104 (e.g., in a deflation cycle). In some examples, the active valve 118 can be moved to a closed position to retain (e.g., substantially retain) 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 the fluid back to the fluid reservoir 102. In some examples, the active valve 118 can be used to retain (e.g., substantially retain) the partial expansion pressure.

[0047] 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 connected in series with pumps 120-1, 120-2, and / or 120-3. In some examples, additional active valves 118 (e.g., series active valves 118) may be located in a fluid path section connected to the fluid reservoir 102. In some examples, additional active valves 118 (e.g., series active valves 118) may be located in a fluid path section connected to the inflatable member 104. These additional active valves 118 can reduce leakage when at maximum or partial expansion pressure.

[0048] 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.

[0049] The pressure sensor 130 is configured to measure the pressure 172 of the inflatable member 104. The controller 114 may include a pressure controller 174 that receives pressure readings from the pressure sensor 130 according to a pressure sensing speed (pressure sensing rate) 176. Each pressure reading may represent the pressure 172 of the inflatable member 104 at the time of reading.

[0050] The controller 114 (e.g., pressure controller 174) and pressure sensor 130 can adjust the pressure 172 of the inflatable member 104. For example, when the inflatable member 104 is compressed, a pressure increase (or spike) may occur. However, the pressure adjustment discussed herein can minimize or prevent injury to the patient or damage to the inflatable penile prosthesis 100. The pressure controller 174 can control the pressure 172 of the inflatable member 104 based on the combination of the pump 120 and the active valve 118.

[0051] For example, the pressure controller 174 can receive a pressure reading from the pressure sensor 130 and, in response to the measured pressure 172 being higher than a threshold, activate the active valve 118 to the open position to send a portion of the fluid back from the expandable member 104 to the fluid reservoir 102. In some examples, the threshold is the maximum pressure threshold 160-1. In some examples, the threshold is the maximum pressure threshold 160-2. In some examples, the threshold is a pressure value higher than the maximum pressure threshold 160-1 and / or the maximum pressure threshold 160-2. In some examples, the pressure controller 174 can open the active valve 118 in response to the pressure 172 being higher than a threshold for a predetermined period of time. For example, if the measured pressure 172 exceeds a threshold for a predetermined period of time, the pressure controller 174 switches the active valve 118 to the open position. In response to the detection that the pressure 172 corresponds to (or is below) a threshold, the pressure controller 174 can switch the active valve 118 to the closed position.

[0052] In some cases, there may be small leaks through the pump 120, passive valve, and active valve 118, and these leaks may increase with higher pressure increases during sexual activity. However, in response to the measured pressure 172 being lower than the target pressure, the pressure controller 174 may activate one or more pumps 120 to transfer additional fluid to the inflatable member 104 so that the target pressure can be reached. In some cases, the target pressure is a pressure set by the patient.

[0053] In some examples, when the inflatable member 104 is inflated to a target pressure (e.g., during sexual activity), the controller 114 may increase the pressure sensing rate 176 that receives pressure readings (e.g., pressure 172 is measured at high intervals during sexual activity). For example, the controller 114 may include a pressure sensing rate controller 180 configured to control (e.g., adjust) the pressure sensing rate 176. In some examples, the pressure sensing rate controller 180 sets the pressure sensing rate 176 (e.g., a higher pressure sensing rate 176) to a first value in response to the detection that an inflation cycle has been initiated, that the pressure 172 in the inflatable member 104 is close to or at the target pressure, and / or an activity level 186 and / or type of activity 190 indicating sexual activity. The activity level 186 and / or type of activity 190 may be determined based on information obtained by the accelerometer 154, with respect to this determination, as described later in the disclosure of the present invention. In some cases, the pressure-sensing rate controller 180 can adjust the pressure-sensing rate 176 to a second value (e.g., a lower pressure-sensing rate 176) in response to the activation of a contraction cycle and the relatively low pressure 172 in the inflatable member 104 (e.g., at a partial expansion threshold 162-1 or 162-2 or at zero PSI). For example, when the inflatable member 104 is not expanded (or has not expanded to its target pressure), the pressure-sensing rate controller 180 can reduce the pressure-sensing rate 176, thereby saving battery energy.

[0054] 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 sensor 130 may be located between active valves 118. In some examples, the pressure sensor 130 may be located between two pumps 120 connected in series. In some examples, the pressure sensor 130 may be located between two pumps 120 connected in parallel. In some examples, the pressure sensor 130 may be located between the active valves 118 and the pumps 120. In some examples, the pressure sensor 130 may be connected to a fluid reservoir 102 and capable of measuring the pressure in the fluid reservoir 102. The pressure sensor 130 is communicatively coupled to the controller 114 so that the controller 114 can receive signals from it. 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.

[0055] The electronic pump assembly 106 may include an accelerometer 154 configured to measure the acceleration 182 of the user of the inflatable penile prosthesis 100. The accelerometer 154 can measure the magnitude and direction of acceleration 182 in one or more directions. In some examples, the accelerometer 154 is a multi-axis accelerometer that can measure the magnitude and direction in multiple directions (e.g., x, y, and / or z). The information from the accelerometer 154 can be used to determine the activity level 186. For example, the controller 114 may include an activity level detector 184 configured to receive accelerometer readings from the accelerometer 154 (in this case, each accelerometer reading includes the magnitude and direction of acceleration 182 in one or more directions), and the activity level detector 184 can determine the activity level 186. In some examples, a high value (over a period) for the activity level 186 may indicate that the user is exercising. In some examples, a low value (over a period) for the activity level 186 may indicate that the user is resting or sleeping.

[0056] In some examples, the controller 114 includes an activity type detector 184 configured to determine the type of activity 190 based on the activity level 186 from the activity level detector 184. In some examples, the type of activity 190 can be a classification of what activity the user is currently engaged in, such as exercise, rest, sleep, or movement. In some examples, the activity level detector 184 and the activity type detector 188 are combined into a single module that receives acceleration readings to determine the activity level 186 and / or the type of activity 190. In some examples, the activity level detector 184 and / or the activity type detector 188 are configured to identify the sleep pattern of the inflatable penile prosthesis user based on the measured acceleration 182 (in some examples, in combination with one or more other signals such as time). While the user is asleep, the controller 114 can inflate the inflatable member 104 (e.g., partially inflating or inflating to a target pressure).

[0057] For example, controller 114 may include an inflation controller 194 configured to control nocturnal erections and / or irregular erections. Nocturnal penile engorgement is a spontaneous erection of the penis during sleep or while awake and can contribute to penile health. To give the patient a more realistic feel, the inflation controller 194 can induce nocturnal erections. In some examples, the inflation controller 194 can inflate the inflatable member 104 at set (or irregular) times during the night (e.g., from 3 a.m. to 6 a.m.). In some examples, the inflation controller 194 can inflate the inflatable member 104 up to an irregular pressure threshold that can be contained therein (and can be modified by the user using an external device 101). In some examples, the inflation controller 194 can receive the type of activity 190 from the activity type detector 188 to confirm that the user is asleep and can further control the pump 120 and active valve 118 to inflate the inflatable member 104. In some cases, the inflation controller 194 can control the pumps 120 (e.g., pumps 120-1 and 120-2) to operate at a lower frequency and / or lower pump flow rate (e.g., a lower frequency and / or pump flow rate than the flow rate used during a patient-initiated inflation cycle) in order to avoid waking the patient.

[0058] In some cases, the inflation controller 194 can inflate the inflatable member 104 at irregular times during the day (e.g., irregular erections). In some cases, the inflation controller 194 can receive the activity type 190 (or activity level 186 from the activity type detector 188) from the activity type detector 188 to confirm that the user is not engaged in an activity such as exercise, and then proceed to the stage of activating the pump 120 (e.g., pump 120, pump 120-2) to inflate the inflatable member 104. In some cases, the inflation controller 194 can inflate the inflatable member 104 to an irregular pressure threshold. In some cases, the number of nocturnal erections and / or irregular erections can be controlled by the patient, for example, the patient can select an appropriate number of times for nocturnal erections and / or irregular erections to occur.

[0059] In some examples, the controller 114 may include a trial period controller 192 configured to control inflation and deflation cycles after the inflatable penile prosthesis 100 has been implanted in the patient's body. For example, a healing period is required after the inflatable penile prosthesis 100 has been implanted in the body. After the healing period, the patient may be instructed to start inflation and deflation cycles in their device. However, in embodiments discussed herein, the trial period controller 192 can perform a smart process that automatically executes inflation / deflation cycles in controlled segments. For example, the trial period controller 192 can iteratively start inflation and deflation cycles during a trial period (e.g., spanning a few days, a few weeks, or a few months). In some examples, the trial period includes a series of partial durations (e.g., four one-week periods) in which inflation and deflation settings are adjusted. For example, in each subsequent partial duration, the pressure 172 within the inflatable member 104 is adjusted (e.g., increased).

[0060] For example, during the first partial duration, the test period controller 192 can inflate the inflatable member 104 to a first pressure, hold the inflatable member 104 at the first pressure, and then deflate the inflatable member 104. In some examples, when activated, the test period controller 192 controls the timing of expansion and contraction, as well as when to contract. In some examples, the test period controller 192 can set the target pressure to a first pressure, and the user is allowed to control the expansion, contraction, and timing, but the maximum pressure is the first pressure. During the second partial duration (e.g., the following week), the test period controller 192 can inflate the inflatable member 104 to a second pressure, hold the inflatable member 104 at the second pressure, and then deflate the inflatable member 104. In some examples, the second pressure is higher than the first pressure. In some examples, when activated, the test period controller 192 controls the timing of expansion and contraction, as well as when to contract. In some cases, the test period controller 192 can set the target pressure to a second pressure, and the user is allowed to control the expansion, contraction, and timing, but the maximum pressure is the second pressure. During the third partial duration, the test period controller 192 can expand the inflatable member 104 to a third pressure, hold the inflatable member 104 at the third pressure, and then contract the inflatable member 104. In some cases, the third pressure is higher than the second pressure. In some cases, when activated, the test period controller 192 controls the expansion and contraction, as well as the timing of when to contract. In some cases, the test period controller 192 can set the target pressure to a third pressure, and the user is allowed to control the expansion, contraction, and timing, but the maximum pressure is the second pressure.

[0061] During each partial duration, the test period controller 192 can perform multiple iterations. Similarly, the test period controller 192 can control the timing of when to start each iteration. For example, after the first iteration, the test period controller 192 may wait for a first period, then start the second iteration, then wait for a second period, then start the third iteration, and so on. The time between these iterations may be the same or different (for example, the time between iterations may become shorter or longer as the number of iterations increases). Similarly, in each iteration, the test period controller 192 can control the amount of time the inflatable member 104 is held at its respective pressure (for example, shortening or lengthening the time between the expansion and contraction cycles as the number of iterations increases).

[0062] The electronic pump assembly 106 may include a temperature sensor 152 configured to measure the temperature 191 of the fluid inside it. In some examples, the temperature sensor 152 is included as part of the pressure sensor 130. In some examples, the temperature sensor 152 is a separate sensor from the pressure sensor 130. The temperature sensor 152 may be connected to a portion of the fluid passage within the electronic pump assembly 106. In response to the measured temperature 191 being higher than a threshold, the controller 114 may transmit a notification message 198 to one or more external devices 101 over the network via the antenna 112. For example, the controller 114 may include a notification generator 196 configured to generate a notification message 198 to be transmitted to one or more external devices 101. The notification message 198 may indicate a warning regarding the patient's health, the use of the inflatable penile prosthesis 100, and / or a high level of temperature 191. The notification generator 196 may generate a notification message 198 when the measured temperature 191 is higher than a threshold. Notification message 198 may be sent to the patient's device and / or the physician's device. A temperature 191 with a value higher than the threshold level may be an indicator of infection around the implanted device or possible device malfunction.

[0063] The controller 114 can detect performance problems with the inflatable penile prosthesis 100 based on pressure readings from the pressure sensor 130. For example, it can detect leaks (e.g., leakage events) based on pressure readings from the pressure sensor 130. Furthermore, it can infer the performance of the pumps and active valves from the pressure readings from the pressure sensor 130. For example, the pressure readings may indicate that the pump 120 and / or the active valve 118 are not functioning properly. In some cases, the controller 114 can detect a performance problem if the pump takes more time than a threshold time to reach a predetermined pressure. For example, the controller 114 can use pressure readings from the pressure sensor 130 along with a time scale to detect performance problems associated with one or more of the pumps. In response to the detection of a performance problem based on pressure readings, the notification generator 196 can send a notification message 198 to one or more external devices 101 on the network indicating that the penile prosthesis 100 has one or more performance problems.

[0064] The electronic pump assembly 106 may include one or more sensors 158 configured to monitor the performance of the battery 116, controller 114, accelerometer 154, heart rate monitor 156, and / or other electronic devices on the electronic pump assembly 106. Based on the data received by one or more sensors 158, the controller 114 can determine whether one or more performance metrics 193 relating to the battery 116, controller 114, accelerometer 154, heart rate monitor 156, and / or other electronic devices have reached a target threshold. If the performance metrics 193 have not reached a target threshold, the notification generator 196 may generate a notification message 198 indicating a performance problem associated with one of the electronic devices on the electronic pump assembly 106 and send it to one or more external devices 101 on the network.

[0065] The electronic pump assembly 106 may include a heart rate monitor 156 configured to monitor the heart rate of the user of the inflatable penile prosthesis 100. In some examples, the controller 114 is configured to record heart rate data 166 and store it on a memory device 115. In some examples, the heart rate data 166 may include information about the heart rate when the inflatable member 104 is inflated and / or during sexual activity. In some examples, the heart rate data 166 may correlate pressure 172 from pressure readings with the user's heart rate. In some examples, the heart rate data 166 may associate pressure changes received from a pressure sensor 130 with the heart rate. In some examples, the heart rate data 166 may associate acceleration 182 from acceleration readings from an accelerometer 154 with the heart rate. The controller 114 may periodically transmit the heart rate data 166 to one or more external devices 101.

[0066] The controller 114 can partially inflate the inflatable member 104 so that the pressure 172 of the inflatable member 104 does not exceed a threshold (e.g., zero PSI). For example, the controller 114 may include a partial inflation controller 195 that controls the pump 120 and an active valve to inflate the inflatable member 104 so that the pressure 172 of the inflatable member 104 does not exceed a threshold (e.g., zero PSI). The inflatable member 104 can be empty or full, but both can still be at zero PSI. In some examples, the partial inflation controller 195 can operate the active valve 118 to the closed position to cause the pump 120 to fill the inflatable member 104 with fluid, while still maintaining the pressure 172 at zero PSI (or substantially around zero PSI (e.g., 1 PSI or 2 PSI)). The inflatable penile prosthesis 100 can maintain a partial inflation pressure in equilibrium under static conditions, and since there is no pressure difference, no leakage will occur.

[0067] In some cases, the fluid pumps 120 (e.g., pump 120-1, pump 120-2) are biased in the forward direction. In the case of a positive pressure difference between the fluid reservoir 102 and the inflatable member 104, some fluid (e.g., leak fluid) may move through the passive valves of each pump 120. This fluid movement may occur, for example, during certain gym training and other exercises, in which case abdominal pressure may be applied to the fluid reservoir. The forward pressure through the forward-biased pumps may cause pressure to build up inside the inflatable member 104, which may cause unintended partial inflation for the patient.

[0068] The controller 114 may include a pressure release controller 168 configured to adjust the activation of a discharge pump (e.g., pump 120-3) and / or the opening of an active valve 118 using a pressure pulsation 170. The pulsation 170 can be measured by a pressure sensor 130. The pulsation 170 can be a short increase in pressure 172. Immediately following the pulsation 170, the pressure release controller 168 can adjust the timing of the opening of the active valve 118 to release pressure 172 from the inflatable member 104. This opening is followed by the closing of the active valve 118, and then the next pulsation 170. For example, the pressure release controller 168 can acquire pressure readings from the pressure sensor 130 over time according to a pressure sensor rate 176. The pressure release controller 168 can detect a first pressure pulsation 170-1 in a first time and a second pressure pulsation 170-2 in a second time. The pressure release controller 168 may open the active valve 118 after a first time interval (and in some examples start the pump 120-3). In some examples, the pressure release controller 168 operates the pump 120-3 at a frequency lower than the frequency normally used to drive the pump 120-3 during a contraction cycle. The pressure release controller 168 may close the active valve 118 before a second time interval (and in some examples stop the pump 120-3).

[0069] The pressure release controller 168 can release fluid from the inflatable member 104 by opening the active valve 118 after a period of high activity and, in some cases, by activating the pump 120-3. For example, as described above, forward pressure through a forward-biased pump may cause pressure to build up in the inflatable member 104, which may cause unintended partial inflation in the patient. However, the pressure release controller 168 can receive pressure readings from the pressure sensor 130, as well as the activity level 186 and / or activity type 190. For example, during the first period, the activity level 186 may be relatively high and indicate exercise activity type 164-1. During the second period, the activity level 186 may be relatively low and indicate rest activity type 164-2. In some cases, at the end of the first period (or the beginning of the second period), the pressure release controller 168 can open the active valve 118 and activate the pump 120-3. In some cases, the pressure release controller 168 can drive the pump 120-3 at a frequency lower than the frequency used during the contraction cycle.

[0070] The electronic pump assembly 106 may include a sealed enclosure 108 that encloses its components. The sealed enclosure 108 may be an airtight (or substantially airtight) container. The sealed enclosure 108 may include 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 defines a through-connection 140 (e.g., a sealed through-connection, an electrical through-connection, a through-connection connector, etc.) for receiving / transmitting radio signals to / from an external device 101. In some examples, the through-connection 140 includes a metal-based material and an insulator-based material (e.g., ceramic).

[0071] The electronic pump assembly 106 may include a sealed fluid chamber 110 located inside the sealed enclosure 108. The sealed fluid chamber 110 may be a separate, airtight (or substantially airtight) container within the sealed enclosure 108. The sealed fluid chamber 110 may include one or more metal-based materials. In some examples, the sealed fluid chamber 110 is a titanium container. In some examples, the sealed fluid chamber 110 includes one or more non-metal-based materials (e.g., ceramics). In some examples, part of the sealed fluid chamber 110 is a metal-based material (e.g., titanium) and part is a non-metal-based material (e.g., ceramics). The sealed fluid chamber 110 can isolate the fluid from electronic equipment (e.g., a controller 114, an accelerometer 154, a heart rate monitor 156, one or more sensors 158, 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 the fluid reservoir 102 and the expandable member 104. The sealed fluid chamber 110 may include an active valve 118, a pump 120, a pressure sensor 130, and a temperature sensor 152. In some examples, the sealed fluid chamber 110 defines a through-connection 138 (e.g., a sealed through-connection, an electrical through-connection, a through-connection 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 includes only one sealed enclosure (e.g., sealed enclosure 108).

[0072] Figure 2A shows an electronic pump assembly 206 according to one embodiment. Figure 2B shows a check valve 221 arranged in series with one of the pumps 220 according to one embodiment. Figure 2C shows a check valve 221 arranged in series with one of the pumps 220 according to another embodiment. The electronic pump assembly 206 may be an example of the electronic pump assembly 106 in Figures 1A and 1B and may include any of the details discussed with reference to these figures.

[0073] The electronic pump assembly 206 includes an active valve 218, pumps 220-1 and 220-2, and a pressure sensor 230. Pump 220-1 may include an inlet and an outlet. The inlet of pump 220-1 can be fluidically connected to a fluid reservoir 202, and the outlet of pump 220-1 can be fluidically connected to an inflatable member 204. Pump 220-2 may include an inlet and an outlet. The inlet of pump 220-2 can be fluidically connected to a fluid reservoir 202, and the outlet of pump 220-2 can be fluidically connected to an inflatable member 204. The active valve 218 may include an inlet and an outlet. The inlet of the active valve 218 can be fluidically connected to an inflatable member 204, and the outlet of the active valve 218 can be fluidically connected to a fluid reservoir 202.

[0074] Pumps 220-1 and 220-2 are electronically controlled pumps. Pumps 220-1 and 220-2 can be electronically controlled by a controller (for example, controller 114 in Figures 1A and 1B). In some examples, pumps 220-1 and 220-2 are unidirectional, capable of transferring fluid from the fluid reservoir 202 to the 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 or a piezoelectric pump.

[0075] 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 in different phases from each other to increase the efficiency of the electronic pump assembly 206. In some cases, two parallel pumps operating at different phases (e.g., 180-degree phases apart) (e.g., pump 220-1, pump 220-2) can improve overall performance by allowing the output pressure of pump 220-1 to improve valve closure of pump 220-2 (and vice versa). In some cases, the use of parallel pumps operating at different phases (e.g., pump 220-1, pump 220-2) can allow pumps 220-1 and 220-2 to operate at lower frequencies, thereby reducing power consumption (and thus extending battery life). Smoother flow rates can also be achieved, resulting in less vibration and an improved patient experience.

[0076] The active valve 218 can be an electronically controlled valve. The active valve 218 can be electronically controlled by a controller (e.g., controller 114 in Figures 1A and 1B). For example, the active valve 218 can receive a signal to move between an open position where fluid flows through it and a closed position where fluid flow is prevented. In some examples, the active valve 218 can move 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 move 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 the fluid back to the fluid reservoir 202. In some examples, the active valve 218 can be used to maintain (e.g., substantially maintain) partial expansion pressure.

[0077] 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 a controller (e.g., controller 114 in Figures 1A and 1B) so that the controller can receive signals from the pressure sensor 230.

[0078] In some examples, as shown in Figures 2C and 2C, the electronic pump assembly 206 may include a check valve 221 positioned in series with the pump 220 (in this case, the pump 220 may be pump 220-1, pump 220-2, or both). In some examples, as shown in Figure 2B, the check valve 221 is positioned between the pump 220 and the inflatable member 204. In some examples, as shown in Figure 2C, the check valve 221 is positioned between the pump 220 and the fluid reservoir 202. The check valve 221 may define a cracking pressure 227. When the pressure difference between the inlet and outlet of the check valve 221 is higher than the cracking pressure 227, the check valve 221 is configured to open, allowing the fluid to pass through. When the pressure difference between the inlet and outlet of the check valve 221 is lower than the cracking pressure 227, the check valve 221 is configured to close, thereby preventing the transfer of fluid. In some examples, the cracking pressure 227 is in the range of 1.0 PSI to 5.0 PSI. In some examples, the cracking pressure 227 is in the range of 2.0 PSI to 4.0 PSI. In some examples, the cracking pressure 227 is 3.0 PSI. A check valve 221 placed in series with the pump 220 can reduce leakage or unintended flow from the fluid reservoir 202 to the inflatable member 204 during activities that apply abdominal pressure to the fluid reservoir 202. In some examples, the check valve 221 is closed during normal non-erect periods to ensure that unintended partial erections are minimized.

[0079] Figure 3 shows an electronic pump assembly 306 in an embodiment. The electronic pump assembly 306 may be an example of the electronic pump assembly 106 in Figures 1A and 1B and / or the electronic pump assembly 206 in Figures 2A to 2C, and may include any of the details discussed with reference to these figures. The electronic pump assembly 306 may be the same as the electronic pump assembly 206 in Figures 2A to 2C, except that it includes a discharge pump (e.g., pump 320-3).

[0080] The electronic pump assembly 306 includes an active valve 318, pumps 320-1, 320-2, 320-3, and a pressure sensor 230. Pump 320-1 may include an inlet and an outlet. The inlet of pump 320-1 can be fluidically connected to a fluid reservoir 302, and the outlet of pump 320-1 can be fluidically connected to an inflatable member 304. Pump 320-2 may include an inlet and an outlet. The inlet of pump 320-2 can be fluidically connected to a fluid reservoir 302, and the outlet of pump 320-2 can be fluidically connected to an inflatable member 304. Pump 320-3 may include an inlet and an outlet. The inlet of pump 320-3 can be fluidically connected to an inflatable member, and the outlet of pump 320-3 can be fluidically connected to the active valve 318 (and the fluid reservoir 302). The active valve 318 may include an inlet and an outlet. The inlet of the active valve 318 can be fluidically connected to the outlet (and expandable member 304) of the pump 320-2, and the outlet of the active valve 318 can be fluidically connected to the fluid reservoir 302.

[0081] Pumps 320-1, 320-2, and 320-3 are electronically controlled pumps. Pumps 320-1, 320-2, and 320-3 can be electronically controlled by a controller (for example, controller 114 in Figures 1A and 1B). In some examples, pumps 320-1 and 320-2 are unidirectional, capable of transferring fluid from the fluid reservoir 302 to the inflatable member 304. In some examples, pump 320-3 is unidirectional, capable of transferring fluid from the inflatable member 304 to the fluid reservoir 302. However, in some examples, pumps 320-1, 320-2, and 320-3 are bidirectional. In some examples, pumps 320-1, 320-2, and 320-3 can be electromagnetic pumps or piezoelectric pumps.

[0082] Pump 320-1, pump 320-2, or pump 320-3 may include passive check valves 323 and 325. Passive check valves 323 and 325 can help maintain pressure within the inflatable member 304. Pump 320-1 may be placed in parallel with active valve 318. Pump 320-2 may be placed in parallel with pump 320-1. Pump 320-3 may be placed in parallel with active valve 318. Pump 320-3 may be placed in parallel with pump 320-1 or pump 320-2.

[0083] Figure 4 illustrates an example of a portion of an electronic pump assembly 406 according to its configuration. The electronic pump assembly 406 may be an example of the electronic pump assembly 106 in Figures 1A and 1B, the electronic pump assembly 206 in Figures 2A to 2C, and / or the electronic pump assembly 306 in Figure 3, and may include any of the details discussed with reference to these figures.

[0084] The electronic pump assembly 406 is configured to transfer fluid between the fluid reservoir 402 and the inflatable member 404. The electronic pump assembly 406 can automatically transfer fluid between the fluid reservoir 402 and the inflatable member 404 without the user having to manually operate the pump (e.g., by crushing and releasing the pump spherical body).

[0085] The electronic pump assembly 406 includes a pump 420-1 located in a fluid passage 424 (e.g., a filling passage) and an active valve 418 located in a fluid passage 427 (e.g., a discharge passage). Pump 420-1 may be an electromagnetic pump or a piezoelectric pump. Pump 420-1 may include a passive check valve 423 and a passive check valve 425. Fluid passage 427 may be a fluid branch separate from (and in parallel with) fluid passage 424. Fluid passage 427 is a passage that transfers fluid from the fluid reservoir 402 to the inflatable member 404. Fluid passage 424 is a passage that transfers fluid from the inflatable member 404 to the fluid reservoir 402. Pump 420-1 is located in parallel with the active valve 418.

[0086] In some examples, the electronic pump assembly 406 may include an active valve 419 in series with pump 420-1 (pump 420-1 and active valve 419 are located in the fluid passage 427). In some examples, the electronic pump assembly 406 may include pump 420-2 in series with active valve 418 (for example, pump 420-2 and active valve 418 are located in the fluid passage 424). Pump 420-2 may be an electromagnetic pump or a piezoelectric pump. Pump 420-2 may include passive check valves 423 and 425. In some examples, the electronic pump assembly 406 may include an active valve 448 fluidically connected to a fluid reservoir 402. Active valve 448 may be in series with either active valve 418 (and pump 420-2) or pump 420-1 (and active valve 419). In some examples, the electronic pump assembly 406 includes an active valve 452 that is fluidly connected to an inflatable member 404. The active valve 452 may be connected in series with either an active valve 419 (and pump 420-1) or pump 420-2 (and active valve 418).

[0087] The active valve 448, pump 420-1, active valve 418, active valve 452, active valve 418, and pump 420-2 can be electronically controlled by a controller and / or driver (e.g., controller 114 in Figures 1A and 1B). Pumps 420-1 and 420-2 can be unidirectional or bidirectional. With respect to the fluid passage 427, in some examples, pump 420-1 and active valve 419 can be swapped (in this case, active valve 419 is in series between active valve 448 and pump 420-1). With respect to the fluid passage 424, in some examples, active valve 418 and pump 420-2 can be swapped (in this case, pump 420-1 is in series between active valve 418 and active valve 448).

[0088] In some examples, one or more additional active valves and / or one or more additional pumps are arranged in series within the fluid passage 427. In some examples, one or more additional active valves and / or one or more additional pumps are arranged in series within the fluid passage 424. In some examples, the electronic pump assembly 406 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.

[0089] In some examples, the electronic pump assembly 406 may include pressure sensors 430 and 431. Pressure sensors 430 and 431 are connected to a controller (for example, controller 114 in Figures 1A and 1B), in which case the controller receives the measured pressure from pressure sensors 430 and 431.

[0090] The pressure sensor 430 is configured to measure the pressure within the inflatable member 404. The controller can receive the measured pressure from the pressure sensor 430 and automatically control the active valve and / or pump to adjust this pressure. In some examples, the pressure sensor 431 is configured to measure the pressure within the fluid reservoir 402. In some examples, the pressure sensor 431 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 406 may include one or more pressure sensors elsewhere inside it. For example, the pressure sensor may be located between the active valve 448 and pump 420-1. In some examples, the pressure sensor may be located between pump 420-1 and active valve 419. In some examples, the pressure sensor may be located between active valve 448 and active valve 418. In some examples, the pressure sensor may be located between active valve 418 and pump 420-2.

[0091] Figure 5 schematically illustrates an inflatable penile prosthesis 500 having an electronic pump assembly 506 according to its embodiment. The electronic pump assembly 506 may include any of the features of the electronic pump assemblies (e.g., 106, 206, 306, 406) and inflatable penile prostheses (e.g., 100, 200) discussed herein. The inflatable penile prosthesis 500 may include a pair of inflatable cylinders 510, which are configured to be embedded in the penis. For example, one inflatable cylinder 510 may be positioned on one side of the penis, and the other inflatable cylinder 510 may be positioned on the other side of the penis. Each inflatable cylinder 510 may include a first terminal portion 524, a cavity or inflation chamber 522, and a second terminal portion 528 having a posterior tip 532.

[0092] At least a portion of the electronic pump assembly 506 can be implanted in the patient's body. A pair of conduit connectors 505 can be used to attach the electronic pump assembly 506 to the inflatable cylinder 510 so that the electronic pump assembly 506 is in fluid communication with the inflatable cylinder 510. Similarly, the electronic pump assembly 506 can be in fluid communication with the fluid reservoir 550 through the conduit connector 503. The fluid reservoir 550 can be implanted in the user's abdomen. The inflation chamber 522 of the inflatable cylinder 510 can be placed inside the penis. The first terminal portion 524 of the inflatable cylinder 510 can be placed at least partially inside the glans portion of the penis. The second terminal portion 528 can be implanted in the patient's pubic region PR with its posterior tip 532 close to the pubic bone PB.

[0093] To implant the inflatable cylinder 510, the surgeon prepares the patient. Often, 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 510. This corpus cavernosum is the one of the two parallel columns of erectile tissue, for example, the two elongated columns that form the dorsal part of the penile body extending substantially the entire length of the penis. The surgeon will also expand two areas of the pubic region to prepare the patient to receive a second distal portion 528. 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 510 to be implanted.

[0094] After the patient is ready, the penile prosthesis 500 is implanted in the patient. The tip of the first terminal portion 524 of each inflatable cylinder 510 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 expanded corpus cavernosum. The needle member is then pushed through the glans of the penis. The surgeon pulls the suture to draw the inflatable cylinder 510 into the corpus cavernosum. This draw-in is performed for each inflatable cylinder 510 that makes up a pair. Once the expansion chamber 522 is in position, the surgeon can remove the suture from the tip. The surgeon then inserts the second terminal portion 528. The surgeon inserts the posterior end of the inflatable cylinder 510 into the incision and pushes the second terminal portion 528 toward the pubic bone PB until each inflatable cylinder 510 is in position.

[0095] The user can control the inflatable penile prosthesis 500 using an external device 501. In some examples, the user can inflate or deflate the inflatable cylinder 510 using the external device 501. For example, in response to the user initiating an inflation cycle using the external device 501, the external device 501 can send a radio signal to the electronic pump assembly 506 to initiate the inflation cycle and transfer fluid from the fluid reservoir 550 to the inflatable cylinder 510. In some examples, in response to the user initiating a deflation cycle using the external device 501, the external device 501 can send a radio signal to the electronic pump assembly 506 to initiate the deflation cycle and transfer fluid from the inflatable cylinder 510 to the fluid reservoir 550. In some examples, during the deflation cycle, fluid is transferred and returned until the pressure inside the inflatable cylinder 510 reaches a partial inflation pressure.

[0096] Figure 6 illustrates flowchart 600, which shows an exemplary operation of an electronic pump assembly for an inflatable penile prosthesis. The exemplary operation in flowchart 600 can be performed by any of the inflatable penile prostheses and / or electronic pump assemblies discussed herein (e.g., 106, 206, 306, 406, 506).

[0097] Act 602 includes the step of receiving a radio control signal from an external device via the antenna of the electronic pump assembly. Act 604 includes the step of, in response to the radio control signal, the controller instigating the pump of the electronic pump assembly to transfer fluid from the fluid reservoir to the inflatable member so that the pressure of the inflatable member reaches a threshold. Act 606 includes the step of measuring the pressure of the inflatable member using a pressure sensor. Act 608 includes the step of, in response to the measured pressure being higher than the threshold, the controller instigating the active valve of the electronic pump assembly to the open position to transfer a portion of the fluid from the inflatable member to the fluid reservoir. In some examples, the act includes the step of the controller detecting that the measured pressure corresponds to the threshold. In some examples, the act includes the step of, in response to the detection that the measured pressure corresponds to the threshold, the controller instigating the active valve to the closed position.

[0098] 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 disclosed herein should not be interpreted as limiting, but rather as representative grounds for the claims and for demonstrating to those skilled in the art how these embodiments can be adapted in various ways 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.

[0099] 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, but not necessarily direct and mechanical.

[0100] Generally, the embodiments relate to body implants. In this specification, the terms patient or user may be used to refer to an individual who benefits from a medical device or method disclosed in the disclosure of the present invention. For example, a patient may be an individual who has an implant made in their body using a medical device or method for operating it as disclosed in the disclosure of the present invention. For example, in some embodiments, a patient may be a human being.

[0101] While certain features of the described implementation have been shown above in this specification, many modifications, substitutions, variations, and equivalents will be conjured upon those skilled in the art. It will be understood that the appended claims are intended to cover all such modifications and variations within the scope of the embodiments. [Explanation of Symbols]

[0102] 100 Inflatable Penile Prostheses 102 Fluid reservoir 104 Expandable member 108 Sealed Enclosure 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 Pump and Active valves and A pressure sensor configured to measure the pressure of the expandable member, A controller configured to control at least one of the pump or the active valve based on the measured pressure, Includes an accelerometer configured to measure the user's acceleration of the inflatable penile prosthesis, An inflatable penile prosthesis wherein the controller is configured to determine the type of activity based on measured acceleration, and the controller is configured to adjust the pressure sensing rate associated with the pressure sensor based on the type of activity.

2. The inflatable penile prosthesis according to claim 1, wherein the controller is configured to open the active valve in response to the measured pressure being higher than a threshold, so as to transfer a portion of the fluid from the inflatable member to the fluid reservoir.

3. The inflatable penile prosthesis according to claim 1, wherein the controller is configured to operate the pump to transfer a portion of the fluid from the fluid reservoir to the inflatable member in response to the measured pressure being below a threshold.

4. The inflatable penile prosthesis according to claim 1, wherein the fluid reservoir includes a flexible balloon configured to transfer a portion of the fluid from the fluid reservoir to the inflatable member in order to partially inflate the inflatable member without operating the pump.

5. A fluid reservoir configured to hold a 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 Pump and Active valves and A pressure sensor configured to measure the pressure of the expandable member, A controller configured to control at least one of the pump or the active valve based on the measured pressure, Includes an accelerometer configured to measure the user's acceleration of the inflatable penile prosthesis, An inflatable penile prosthesis wherein the controller is configured to identify the user's sleep pattern based on measured acceleration, and the controller is configured to inflate the inflatable member at least partially when the user is sleeping.

6. The inflatable penile prosthesis according to claim 1, wherein the electronic pump assembly includes a heart rate sensor configured to monitor the heart rate of the user of the inflatable penile prosthesis.

7. The inflatable penile prosthesis according to claim 1, wherein the electronic pump assembly includes a temperature sensor configured to measure the temperature of the fluid.

8. The inflatable penile prosthesis according to claim 1, wherein the controller is configured to repeatedly initiate inflation and deflation cycles during a trial period after the inflatable penile prosthesis has been implanted in the patient's body, the trial period comprising a series of partial durations, and the pressure within the inflatable member is regulated during each partial duration.

9. A fluid reservoir configured to hold a 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 Pump and Active valves and A pressure sensor configured to measure the pressure of the expandable member, A controller configured to control at least one of the pump or the active valve based on the measured pressure, Includes an accelerometer configured to measure the user's acceleration of the inflatable penile prosthesis, An inflatable penile prosthesis, wherein the controller is configured to partially inflate the inflatable member so that the pressure of the inflatable member does not exceed a partial pressure threshold, and in response to a wireless signal, the controller is configured to inflate the inflatable member to a maximum pressure threshold during the inflation cycle.

10. A fluid reservoir configured to hold a 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 Pump and Active valves and A pressure sensor configured to measure the pressure of the expandable member, A controller configured to control at least one of the pump or the active valve based on the measured pressure, Includes an accelerometer configured to measure the user's acceleration of the inflatable penile prosthesis, An inflatable penile prosthesis comprising a controller including a memory configured to store at least one of a maximum pressure threshold or a partial pressure threshold, and the controller configured to update the value of at least one of the maximum pressure threshold or the partial pressure threshold based on information received from an external device through the antenna of the electronic pump assembly.

11. A fluid reservoir configured to hold a 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 Pump and Active valves and A pressure sensor configured to measure the pressure of the expandable member, A controller configured to control at least one of the pump or the active valve based on the measured pressure, Includes an accelerometer configured to measure the user's acceleration of the inflatable penile prosthesis, An inflatable penile prosthesis, wherein the controller is configured to detect performance problems related to the inflatable penile prosthesis based on pressure readings from the pressure sensor, and the controller is configured to send notification messages over a network to one or more external devices in response to the detection of the performance problem.

12. A fluid reservoir configured to hold a 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 Pump and Active valves and A pressure sensor configured to measure the pressure of the expandable member, A controller configured to control at least one of the pump or the active valve based on the measured pressure, Includes an accelerometer configured to measure the user's acceleration of the inflatable penile prosthesis, An inflatable penile prosthesis comprising a controller configured to acquire pressure readings from the pressure sensor over time according to a pressure sensor rate, the controller configured to detect a first pressure pulsation at a first time and a second pressure pulsation at a second time, the controller configured to open the active valve after the first time and the controller configured to close the active valve before the second time.

Images