CN118369071A

CN118369071A - Electronic implantable penile prosthesis with pressure regulation and other functions

Info

Publication number: CN118369071A
Application number: CN202280080710.2A
Authority: CN
Inventors: 诺尔·史密斯; 爱德华多·马科斯·拉朗吉拉; 布莱恩·P·瓦齐科; 达拉·诺兰; 托马斯·辛诺特; 伊凡妮雅·安·马里纳; 约翰·吉尔迪亚
Original assignee: Boston Scientific Scimed Inc
Current assignee: Boston Scientific Scimed Inc
Priority date: 2021-12-21
Filing date: 2022-12-20
Publication date: 2024-07-19

Abstract

According to one aspect, an inflatable penile prosthesis includes a fluid reservoir configured to contain a fluid, an inflatable member, and an electronic pump fitment configured to transfer the 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 a pressure of the inflatable member, and a controller configured to control at least one of the pump or the active valve based on the measured pressure.

Description

Electronic implantable penile prosthesis with pressure regulation and other functions

RELATED APPLICATIONS

The present application is a continuation of, and claims priority to, U.S. non-provisional patent application Ser. No. 18/068,108 entitled "electronic implantable penile prosthesis with pressure adjustment and other functionality" filed on month 12 of 2022, which claims priority to U.S. provisional application Ser. No. 63/265,812 entitled "electronic implantable penile prosthesis with pressure adjustment and other functionality" filed on month 21 of 2021, the contents of which are incorporated herein by reference in their entirety.

The present application also claims priority from U.S. provisional application No. 63/265,812, filed on 12/21 of 2021, the contents of which are incorporated herein by reference in their entirety.

Technical Field

The present disclosure relates generally to body implants, and more particularly to body implants, such as electronically implantable penile prostheses with pressure regulation and other functions.

Background

One treatment for male erectile dysfunction is the implantation of penile prostheses to cause penile erection. Some existing penile prostheses include inflatable cylinders or members that can be inflated or deflated using a pumping mechanism. The pump mechanism includes an implantable scrotum pump that can be manually squeezed by a user to move fluid from the reservoir into the cylinder to establish an erection. For some patients, manual pumping procedures can be relatively challenging.

Disclosure of Invention

According to some aspects, the inflatable penile prosthesis may include one or more (or any combination) of the following features. The controller is configured to cause the active valve to be in an open position to transfer a portion of the fluid from the expandable member to the fluid reservoir in response to the measured pressure being greater than the threshold. The controller is configured to cause the pump to operate to transfer a portion of the fluid from the fluid reservoir to the expandable member in response to the measured pressure being less than the threshold. The fluid reservoir includes a pressure-regulating flexible member configured to cause the expandable member to be partially expanded without operating the pump. The electronic pump assembly includes an accelerometer configured to measure acceleration of a user of the inflatable penile prosthesis. The controller is configured to identify a sleep mode of a user of the inflatable penile prosthesis based on the measured acceleration, and the controller is configured to cause the inflatable member to at least partially inflate when the user is asleep. The electronic pump assembly includes a heart rate sensor configured to monitor a heart rate of a user of the inflatable penile prosthesis. The electronic pump assembly includes a temperature sensor configured to measure a temperature of the fluid. The controller is configured to iteratively initiate an inflation cycle and a deflation cycle over a period of time, wherein at each subsequent iteration, the pressure in the inflatable member is increased.

According to one aspect, an inflatable penile prosthesis includes a fluid reservoir configured to contain a fluid, an inflatable member, and an electronic pump fitment configured to transfer the fluid between the fluid reservoir and the inflatable member. The electronic pump assembly includes an antenna configured to receive a wireless signal from an external device, a pump, an active valve, a pressure sensor configured to measure a 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 wireless signal.

According to some aspects, the inflatable penile prosthesis may include one or more (or any combination) of the following features. The electronic pump assembly includes an accelerometer configured to measure acceleration of a user of the inflatable penile prosthesis. The controller is configured to determine a type of activity based on the measured acceleration, wherein the controller is configured to adjust a pressure sensing frequency associated with the pressure sensor based on the type of activity. The controller is configured to partially inflate the inflatable member such that a pressure of the inflatable member does not exceed a threshold, wherein, in response to the wireless signal, the controller is configured to inflate the inflatable member to a maximum pressure threshold during an inflation cycle. The electronic pump assembly includes a temperature sensor configured to measure a temperature of the fluid, wherein, in response to the measured temperature being greater than a threshold, the controller is configured to send a notification message to one or more external devices over the network via the antenna. The controller includes a memory configured to store at least one of a maximum pressure threshold or a partial pressure threshold, wherein the controller is configured to update a value of the at least one of the maximum pressure threshold and the partial pressure threshold based on information received from an external device via the antenna. The controller is configured to detect a performance issue associated with the inflatable penile prosthesis based on the pressure reading from the pressure sensor, wherein the controller is configured to send a notification message to one or more external devices over the network in response to the performance issue being detected. The electronic pump assembly includes a battery configured to provide electrical power to the controller, and the electronic pump assembly includes a sensor configured to monitor battery performance. The controller is configured to obtain pressure readings from the pressure sensor over time as a function of the pressure sensor frequency, wherein the controller is configured to detect a first pressure pulsation at a first time and a second pressure pulsation at a second time, and the controller is configured to cause the active valve to be in an open position after the first time and to cause the active valve to be in a closed position before the second time. The electronic pump assembly includes a check valve in series with the pump.

According to one aspect, a method of operating an inflatable penile prosthesis includes: the method includes receiving, by an antenna of the electronic pump assembly, a wireless control signal from an external device, activating, by a controller, a pump of the electronic pump assembly to operate to transfer fluid from the fluid reservoir to the inflatable member in response to the wireless control signal such that a pressure of the inflatable member reaches a threshold, measuring, by the pressure sensor, the pressure of the inflatable member, and activating, by the controller, an active valve of the electronic pump assembly in an open position to transfer a portion of the fluid from the inflatable member to the fluid reservoir in response to the measured pressure being greater than the threshold. In some examples, the method includes detecting, by the controller, that the measured pressure corresponds to a threshold. In some examples, the method includes activating, by the controller, the active valve in a closed position in response to the measured pressure being detected as corresponding to a threshold.

Drawings

FIG. 1A illustrates an inflatable penile prosthesis with an electronic pump assembly according to one aspect.

Fig. 1B illustrates a controller of an electronic pump assembly according to one aspect.

Figure 2A illustrates an inflatable penile prosthesis with an electronic pump assembly according to another aspect.

Fig. 2B illustrates a check valve in series with a pump of an electronic pump assembly, according to one aspect.

Fig. 2C shows a check valve in series with a pump of an electronic pump assembly according to another aspect.

Fig. 3 illustrates an example of an electronic pump assembly according to an aspect.

Fig. 4 shows an example of an electronic pump assembly according to another aspect.

Figure 5 shows an inflatable penile prosthesis with an electronic pump assembly according to another aspect.

Fig. 6 illustrates a flow chart depicting example operation of an electronic pump assembly in accordance with an aspect.

Detailed Description

The present disclosure relates to an inflatable penile prosthesis that includes an electronic pump fitment that transfers fluid between a fluid reservoir and an inflatable member. The electronic pump assembly may wirelessly communicate with an external device (e.g., a computer, a smart phone, a tablet, a pendant, a key fob, etc.) to control the inflatable penile prosthesis (e.g., to inflate or deflate the inflatable member, updating one or more control parameters). The electronic pump assembly may include a main battery (e.g., a non-rechargeable battery) or a rechargeable battery configured to be recharged by an external charger.

The electronic pump assembly includes one or more pumps (e.g., electronically controlled pumps, such as one or more solenoid pumps 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 a battery or other electronics on the electronic pump assembly. In some examples, the electronic pump assembly includes a temperature sensor.

The controller may actuate the one or more pumps and the one or more active valves to control inflation and deflation of the inflatable member based on control signals sent to the one or more pumps and the one or more active valves. The one or more pumps may be unidirectional or bidirectional. In some examples, the electronic pump assembly includes one or more pumps in parallel with an active valve. In some examples, one or more pumps may transfer fluid to the expandable member during an expansion cycle, and the active valve may transition to an open position during a deflation cycle to allow transfer of fluid back to the fluid reservoir. One or more pumps may transfer fluid to the inflatable member at a relatively high pressure rate as desired. In some examples, the electronic pump assembly includes two or more pumps in parallel, such as a first pump and a second pump, wherein the first pump and the second pump are configured to operate out of phase with each other, which may increase the efficiency of the pumping operation. In some examples, using parallel pumps that operate out of phase with each other may allow the pumps to operate at lower frequencies, which may reduce power and increase battery life. In some examples, the electronic pump assembly may include one or more pumps in series with the pump, which may increase the amount of fluid that may be transferred to the inflatable member over a period of time. In some examples, the electronic pump assembly includes one or more pumps (e.g., evacuation 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., a fill pump).

The individual pump may include one or more passive check valves that transition to a closed position in response to a positive pressure between the expandable member and the fluid reservoir. In some examples, the active valve may transition to a closed position to maintain (e.g., substantially maintain) pressure in the expandable member. In some examples, the active valve may be switched to an open position to relieve pressure in the expandable member and/or allow backflow to the expandable member. In some examples, the electronic pump assembly includes a single active valve. In some examples, the electronic pump assembly includes a plurality of active valves. For example, one or more active valves may be connected in series with the pump or in parallel with the pump.

The electronic pump assembly may include a pressure sensor configured to sense a pressure of the inflatable penile prosthesis. In some examples, the pressure sensor is coupled to the expandable member. The pressure sensor may measure the pressure in the expandable member. The controller may receive the measured pressure from the pressure sensor and automatically control one or more active valves and/or one or more pumps to regulate the pressure in the expandable member.

For example, the electronic pump assembly may receive wireless signals from an external device. The wireless signal may cause the controller to initiate an expansion cycle to transfer fluid from the fluid reservoir to the expandable member such that the pressure of the expandable member reaches a threshold. To initiate the expansion cycle, the controller may activate the active valve in the closed position and activate the pump (or pumps) to move fluid to the expandable member until the pressure of the expandable member reaches a threshold.

The controller and pressure sensor may adjust the pressure of the expandable member (e.g., during sexual activity). For example, in the event of compression of the expandable member, a pressure increase (or spike) may occur. However, the pressure regulation described herein may minimize or prevent injury to the patient or damage to the equipment. For example, the controller may receive a pressure reading from the pressure sensor, and in response to the measured pressure being greater than a threshold (or greater than a threshold for a period of time), the controller may cause the active valve to be in an open position to transfer a portion of the fluid from the expandable member back to the fluid reservoir. In response to the measured pressure corresponding to a threshold (or less than a threshold), the controller may switch the active valve to a closed position.

Furthermore, there may be a small amount of leakage through the one or more pumps, the one or more passive valves, and the one or more active valves, and during sexual activity, such leakage may increase as the greater pressure rises. However, in response to the measured pressure being less than the target threshold, the controller may activate one or more pumps to transfer additional fluid to the expandable member so that the target pressure may be achieved.

In some examples, when the expandable member is expanded to its target pressure (e.g., during sexual activity), the controller may increase the pressure sensing frequency at which the controller receives pressure readings (e.g., pressure is measured at high speed intervals during sexual activity). When the expandable member is not expanded to its target pressure, the controller may decrease the pressure sensing frequency so that electrical power and battery energy may be saved. These pressure regulating operations and other reinforcing operations of the inflatable penile prosthesis are further explained with reference to the drawings.

Fig. 1A illustrates an inflatable penile prosthesis 100 with an electronic pump assembly 106 that may improve the performance of the inflatable penile prosthesis 100 according to one aspect. Fig. 1B illustrates an example of a controller 114 of an electronic pump assembly 106 according to one aspect. The inflatable penile prosthesis 100 includes a fluid reservoir 102, an inflatable member 104, and an electronic pump fitment 106 configured to transfer fluid between the fluid reservoir 102 and the inflatable member 104. The expandable member 104 may be implanted into a user's corpus cavernosum, and the fluid reservoir 102 may be implanted in the user's abdomen or pelvic cavity (e.g., the fluid reservoir 102 may be implanted in a lower portion of the user's abdominal cavity or an upper portion of the user's pelvic cavity). In some examples, at least a portion of the electronic pump assembly 106 may be implemented within the patient.

The expandable member 104 can expand when fluid is injected into the cavity of the expandable member 104. For example, when fluid is injected into the expandable member 104, the expandable member 104 may increase its length and/or width, as well as increase its rigidity. In some examples, the inflatable member 104 includes a pair of inflatable cylinders or at least two cylinders, such as 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 cylinder. The volume of fluid in each cylinder may vary from about 10 milliliters in a smaller cylinder to about 50 milliliters in a larger size. In some examples, the first cylindrical member may be larger than the second cylindrical member. In some examples, the first cylindrical member may have the same dimensions as the second cylindrical member.

The fluid reservoir 102 may include a container having an interior chamber configured to hold or contain a fluid for expanding the expandable member 104. The volumetric capacity of the fluid reservoir 102 may vary depending on the size of the inflatable penile prosthesis 100. The volumetric capacity of the fluid reservoir 102 may be 3 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 different material than the expandable member 104. In some examples, the fluid reservoir 102 contains a greater volume of fluid than the expandable member 104.

In some examples, the fluid reservoir 102 is (or includes) a pressure regulating flexible member 111. The pressure regulating flexible member 111 may cause the expandable member 104 to be partially expanded without activating any of the pumps 120. In some examples, the pressure regulating flexible member 111 includes an inflatable balloon. By providing a pounds Per Square Inch (PSI) pressure level to the pressure regulating flexible member 111, some of the fluid may be transferred from the fluid reservoir 102 to the inflatable member. In some examples, the PSI pressure level is in the range of 1.0PSI to 5.0 PSI. In some examples, the PSI pressure level is in the range of 2.0PSI to 4.0 PSI. In some examples, the PSI pressure level is (or about) 3.0PSI. During the preliminary phase (e.g., before starting the expansion cycle), pressure of the pressure regulating flexible member 111 may cause fluid to be transferred from the fluid reservoir 102 to the expandable member 104. In some examples, the fluid reservoir 102 is an inflatable balloon. In some examples, the pressure regulating flexible member 111 is a structure separate from the fluid reservoir 102 but disposed within a cavity of the fluid reservoir 102. In some examples, the pressure regulating flexible member 111 includes an inflatable balloon disposed within a cavity of the fluid reservoir 102.

The inflatable penile prosthesis 100 may include a first catheter connector 103 and a second catheter connector 105. Each of the first conduit connector 103 and the second conduit connector 105 may define a lumen configured to transfer fluid to the electronic pump assembly 106 and from the electronic pump assembly 106. The first conduit connector 103 may be coupled to the electronic pump fitting 106 and the fluid reservoir 102 such that fluid may be transferred between the electronic pump fitting 106 and the fluid reservoir 102 via the first conduit connector 103. For example, the first conduit connector 103 may define a first lumen configured to transfer fluid between the electronic pump fitting 106 and the fluid reservoir 102. The first conduit connector 103 may include a single or multiple tube members for transferring fluid between the electronic pump fitting 106 and the fluid reservoir 102.

The second conduit connector 105 may be coupled to the electronic pump fitting 106 and the expandable member 104 such that fluid may be transferred between the electronic pump fitting 106 and the expandable member 104 via the second conduit connector 105. For example, the second conduit connector 105 may define a second lumen configured to transfer fluid between the electronic pump fitting 106 and the expandable member 104. The second conduit connector 105 may include a single or multiple tube members for transferring fluid between the electronic pump fitting 106 and the expandable member 104. In some examples, the first conduit connector 103 and the second conduit connector 105 may comprise a silicone rubber material. In some examples, the electronic pump assembly 106 may be directly connected to the fluid reservoir 102.

The electronic pump assembly 106 may automatically transfer fluid between the fluid reservoir 102 and the expandable member 104 without requiring a user to manually operate the pump (e.g., squeeze and release the pump bubbles). The electronic pump assembly 106 includes one or more pumps 120, one or more active valves 118, a controller 114 configured to control the one or more pumps 120 and the active valves 118, and one or more pressure sensors 130. For example, the controller 114 may control one or more pumps 120 to pump fluid between the fluid reservoir 102 and the expandable member 104. The controller 114 may control the active valve 118 to switch between an open position and a closed position. The one or more pumps 120 are configured to transfer fluid (on demand) to the expandable member 104 at a relatively high pressure (e.g., up to about 20.0 PSI).

The electronic pump assembly 106 includes a battery 116 configured to provide electrical power to the controller 114 and other components on the electronic pump assembly 106. In some examples, battery 116 is a non-rechargeable battery. In some examples, the battery 116 is a rechargeable battery. In some examples, the electronic pump assembly 106 (or a portion thereof) (or the controller 114) is configured to be connected to an external charger to charge the battery 116. In some examples, the electronic pump assembly 106 defines a charging interface configured to connect to (or be placed in proximity to) an external charger. In some examples, the charging interface includes a Universal Serial Bus (USB) interface configured to receive a USB charger. In some examples, the charging technique may be electromagnetic or piezoelectric.

The electronic pump assembly 106 includes an antenna 112 configured to wirelessly transmit (and receive) wireless signals 109 to (and from) the external device 101 (or plurality of external devices 101). The external device 101 may be any type of component capable of communicating with the electronic pump assembly 106. The external device 101 may be a computer, a smart phone, a tablet, a pendant, a key fob, etc. In an example, the external device 101 includes one or more devices associated with a user of the inflatable penile prosthesis and one or more devices associated with a 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 executable by an operating system of the external device 101 or by a browser of the external device 101. The application 117 may define one or more user interfaces that allow a user to control the inflatable penile prosthesis 100 and set (or update) further settings or control parameters associated with the inflatable penile prosthesis 100.

The user may use the external device 101 to control the inflatable penile prosthesis 100. The user may use the external device 101 to inflate or deflate the inflatable member 104. For example, in response to a user activating an inflation cycle using the external device 101 (e.g., selecting a user control on the external device 101), the external device 101 may send a wireless signal 109 (received via the antenna 112) to the electronic pump assembly 106 to initiate the inflation cycle, wherein the controller 114 may control the one or more active valves 118 and the one or more pumps 120 to inflate the inflatable member 104 to a target inflation pressure, which may be up to a maximum pressure threshold 160-1 (defined by a physician) or a maximum pressure threshold 160-2 (defined by a patient). The controller 114 may cause the active valve to be in a closed position and activate one or more pumps to move fluid from the fluid reservoir 102 to the expandable member 104. The controller 114 may actuate one or more pumps 120 according to the pump frequency. In some examples, the pumping architecture is designed such that audio frequencies are minimized or avoided. The frequency range of 50hz to 19khz can be perceived by humans. The controller 114 may actuate the pump 120 based on a pump frequency of 50hz or less. In some examples, controller 114 actuates pump 120 according to a pump frequency of 40hz or less. In some examples, controller 114 actuates pump 120 according to a pump frequency of 30hz or less.

The maximum pressure threshold 160-1 may be defined by a physician and is the maximum allowable inflation pressure of the inflatable member 104. In some examples, the maximum pressure threshold 160-1 is programmed at the controller 114 (and may be adjusted by using the external device 101 to update the value stored at the controller 114). The maximum pressure threshold 160-2 may be defined by the patient and be less than (or within the range of) the maximum pressure threshold 160-1. For example, if the maximum pressure threshold 160-1 is 20.0PSI, the maximum pressure threshold 160-2 may be 20.0PSI or less (but not greater than 20.0 PSI). In some examples, the maximum pressure threshold 160-2 is programmed at the controller 114 (and may be adjusted by using the external device 101 to update the value stored at the controller 114).

In response to a user activating a deflation cycle using external device 101 (e.g., selecting user controls on external device 101), external device 101 may send wireless signal 109 (received via antenna 112) to electronic pump assembly 106 to initiate the deflation cycle, wherein controller 114 may control one or more active valves 118 (and in some examples pump 120-3) to transfer fluid from inflatable member 104 to fluid reservoir 102. For example, the controller 114 may control the active valve 118 to move to an open position to allow fluid to be transferred from the expandable member 104 to the fluid reservoir 102. In some examples, the controller 114 may control the one or more pumps 120 to further move fluid from the expandable member 104 to the fluid reservoir 102 during a deflation cycle. In some examples, during the deflation cycle, fluid is transferred back until the pressure in the inflatable member 104 reaches a partial inflation threshold 162-1 (defined by the physician) or a partial inflation threshold 162-2 (defined by the patient). In some examples, the controller 114 may automatically determine to initiate a pinch cycle, which causes the controller 114 to control one or more active valves 118 (and in some examples, pump 120-3) to divert fluid back to the fluid reservoir 102.

The partial inflation pressure (e.g., partial inflation threshold 162-1, partial inflation threshold 162-2) is a pressure threshold that may more closely mimic the user's natural experience and/or personal comfort. The partial inflation threshold 162-1 may be defined by a physician and, in some examples, is the inflation pressure at the end of the deflation cycle. In some examples, the partial inflation pressure is in the range of 0.5PSI to 6.0 PSI. In some examples, inflatable penile prosthesis 100 does not include a partial inflation threshold (162-1 or 162-2), wherein the pressure in inflatable member 104 is approximately 0PSI at the end of the deflation cycle. In some examples, the partial inflation threshold (162-1, 162-2) is an option selectable by the user (e.g., using the external device 101). In some examples, the partial inflation threshold 162-1 is programmed at the controller 114 (and may be adjusted by using the external device 101 to update the value stored at the controller 114). The partial inflation threshold 162-2 may be defined by the patient and be less than (or within the range of) the partial inflation threshold 162-1. For example, if the partial expansion threshold 162-1 is 5.0PSI, the partial expansion threshold 162-2 may be 5.0PSI or less than 5.0PSI. In some examples, the partial inflation threshold 162-2 is programmed at the controller 114 (and may be adjusted by using the external device 101 to update the value stored at the controller 114).

The controller 114 may reduce the pressure 172 of the expandable member 104 from a partial expansion threshold (e.g., 162-1, 162-2) (or target pressure) to a lower value in response to receipt of a control signal (e.g., wireless signal 109) received via the antenna 112. For example, when the expandable member 104 is at a partial expansion threshold (e.g., 162-1, 162-2) or at a target pressure, it may be difficult for the patient to urinate. In some examples, the user may use the external device 101 to send the wireless signal 109 to reduce the pressure 172 of the inflatable member 104 to a predetermined pressure level for urination. The controller 114 may control the one or more active valves 118 and/or the one or more pumps 120 to divert fluid from the expandable member 104 to reduce the pressure 172 from a partial expansion threshold (e.g., 162-1, 162-2) or a target pressure to a predetermined pressure level. The user may then select a recovery control using the external device 101 that sends a wireless signal 109 to the controller 114 to recover the pressure 172 back to the partial inflation threshold (e.g., 162-1, 162-2) or the target pressure.

The controller 114 may be any type of controller configured to control the operation of the one or more pumps 120 and the one or more active valves 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 one or more pumps 120 and the one or more active valves 118. In some examples, one or more of the drivers are separate components from the controller 114. The controller 114 may be communicatively coupled to one or more active valves 118, one or more pumps 120, and one or more pressure sensors 130. In some examples, the controller 114 is connected to one or more active valves 118, one or more pumps 120, and one or more pressure sensors 130 via wired data lines. The controller 114 may include a processor 113 and a memory device 115. The processor 113 may be formed in a substrate configured to execute one or more machine-executable instructions or software, firmware, or a combination thereof. The processor 113 may be semiconductor-based, that is, the processor may include semiconductor material that may execute digital logic. Memory device 115 may store information in a format that may be read and/or executed by processor 113. The memory device 115 may store executable instructions that, when executed by the processor 113, cause the processor 113 to perform certain operations described herein. The controller 114 may receive data via the one or more pressure sensors 130 and/or the external device 101 and control the one or more active valves 118 or the one or more pumps 120 by sending control signals to the one or more active valves 118 and/or the one or more pumps 120.

The memory device 115 may store control parameters that may be set or modified by a user and/or physician using the external device 101. In some examples, the memory device 115 may store a maximum pressure threshold 160-1, a maximum pressure threshold 160-2, a partial expansion threshold 162-1, and/or a partial expansion threshold 162-2. The user or physician may update the control parameters using the external device 101, which may be communicated to the controller 114 via the antenna 112 and then updated in the memory device 115. In some examples, the controller 114 may store the usage statistics 164 in the memory device 115. Usage statistics 164 may include one or more statistics on the use of inflatable penile prosthesis 100. For example, usage statistics 164 may include a number of puffs (e.g., stand up), a target pressure (the pressure to which inflatable member 104 is inflated), and/or a battery condition of battery 116. In some examples, controller 114 may periodically send usage statistics 164 to external device 101.

The external device 101 may communicate with the electronic pump assembly 106 over a network. In some examples, the network includes a short-range wireless network (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 a Local Area Network (LAN), wide Area Network (WAN), cellular network, satellite network, or other types of data networks.

In some examples, electronic pump assembly 106 includes a single pump 120 (such as pump 120-1). Pump 120-1 may be disposed in parallel with active valve 118. In some examples, the electronic pump assembly 106 includes a plurality of pumps 120. For example, pump 120 may include pump 120-1 and pump 120-2. In some examples, the pump 120-1 is disposed in a fluid channel 125 for filling the expandable member 104 (e.g., during an expansion cycle). In some examples, pump 120-2 is disposed in a parallel fluid passage 127 for filling the expandable member 104 (e.g., during an expansion cycle). In some examples, pump 120-2 is disposed in parallel with pump 120-1. Pump 120-1 may transfer fluid according to a first flow rate and pump 120-1 may transfer 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 examples, the first flow rate is different from the second flow rate.

In some examples, pump 120 may include a pump 120-3 disposed in series with active valve 118. The pump 120-3 may transfer fluid from the expandable member 104 to the fluid reservoir 102 (e.g., during a deflation cycle). For example, during a deflate cycle, the controller 114 may activate the active valve 118 in an open position and may activate the pump 120-3 to transfer fluid from the expandable member 104 to the fluid reservoir 102. In some examples, pump 120-3 may divert fluid according to a third flow rate. In some examples, the third flow rate is less than the first flow rate and/or the second flow rate. In some examples, the electronic pump assembly 106 may include one or more serial pumps 120 and one or more parallel pumps 120. The electronic pump assembly 106 may include a fourth pump in parallel with the pump 120-2, a fifth pump in parallel with the fourth pump, and so on. In some examples, the pumps 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.

Each pump 120 is an electronically controlled pump. Each pump 120 may be electronically controlled by the controller 114. For example, each pump 120 may be connected to the controller 114 and may receive a signal to actuate the corresponding pump 120. The pump 120 may be unidirectional in that the pump 120 may transfer fluid from the fluid reservoir 102 to the expandable member 104 (or from the expandable member 104 to the fluid reservoir 102). In some examples, the pump 120 is bi-directional, in that the pump 120 can transfer fluid from the fluid reservoir 102 to the expandable member 104 and from the expandable member 104 to the fluid reservoir 102. In some examples, pump 120 is unidirectional or bidirectional. In some examples, pump 120 includes a combination of one or more unidirectional pumps and one or more bi-directional pumps.

In some examples, pump 120 is an electromagnetic pump that uses electromagnetic waves to move fluid between fluid reservoir 102 and expandable member 104. With respect to electromagnetic pumps, the magnetic fluid is at an angle to the direction of fluid movement and an electrical current is passed through it.

In some examples, pump 120 is a piezoelectric pump. In some examples, the piezoelectric pump may be a diaphragm micro pump that uses 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 may be implemented by a substrate layer (e.g., a single substrate layer) of a high voltage piezoelectric element or may be implemented by multiple substrate layers (e.g., stacked substrate layers) of a low voltage piezoelectric element. In some examples, pump 120 includes a plurality of micropumps (e.g., piezo-electrically driven micropumps) disposed on one or more substrates (e.g., one or more wafers). In some examples, the micropump comprises a silicon-based material. In some examples, the micropump comprises a metal-based (e.g., steel) material. In some examples, pump 120 is non-mechanical (e.g., no moving parts).

In some examples, in the case of multiple pumps 120, each pump 120 may be the same type of pump (e.g., all pumps 120 are electromagnetic pumps or all pumps 120 are piezoelectric pumps). In some examples, one or more pumps 120 are different from one or more other pumps 120. For example, the pump 120 may comprise a different type of piezoelectric pump, or the pump 120 may comprise a different type of electromagnetic pump. The pump 120-1 may be a piezoelectric pump having a first number of micropumps, the pump 120-2 may be a piezoelectric pump having a second number of micropumps, and the pump 120-3 may be a piezoelectric pump having a third number of micropumps (where at least two (or all) of the first, second, and third numbers are different from each other or the same as each other). Pump 120-1 may be an electromagnetic pump, pump 120-2 may be a piezoelectric pump, and pump 120-3 may be an electromagnetic pump or a piezoelectric pump.

Pump 120 may include one or more passive check valves. One or more passive check valves may help maintain pressure in the expandable member 104. In some examples, pump 120 may include a single passive check valve. In some examples, pump 120 may include a plurality of passive check valves, such as two passive check valves or more than two passive check valves (e.g., disposed in series with each other). The one or more passive check valves of the respective pump 120 may not be controlled directly by the controller 114, but rather based on the pressure between the expandable member 104 and the fluid reservoir 102. The one or more passive check valves may be switched between an open position (in which fluid is allowed to flow through the one or more passive check valves) and a closed position (in which fluid is prevented from flowing through the one or more passive check valves). In some examples, with respect to pump 120-1 and pump 120-2, the one or more passive check valves are positively biased to allow passive flow through the one or more passive check valves in a direction from fluid reservoir 102 to expandable member 104 while the one or more passive check valves are in a closed position in a direction of flow from expandable member 104 to fluid reservoir 102. In some examples, the one or more passive check valves transition to the closed position in response to a positive pressure between the expandable member 104 and the fluid reservoir 102. In some examples, the one or more passive check valves transition to the open position in response to a negative pressure between the expandable member 104 and the fluid reservoir 102.

In some examples, the use of two parallel pumps (e.g., pump 120-1, pump 120-2) (or more than two parallel pumps 120) may increase the amount of fluid that may be transferred to the expandable member 104. In some examples, pumps 120 may operate out of phase with each other in order to increase the efficiency of electronic pump assembly 106. Two parallel pumps (e.g., pump 120-1, pump 120-2) operating out of phase (e.g., 180 degrees out of phase) with each other may allow the output pressure of pump 120-1 to increase the valve closure of pump 120-2, thereby increasing overall performance (and vice versa). Using parallel pumps 120 that operate out of phase with each other may allow the pumps 120 to operate at lower frequencies, which may reduce power (and thus extend battery life). In addition, a smoother flow rate may also be achieved, thereby reducing vibration and improving patient experience. As described above, one or more pumps 120 may be in series with one or more pumps 120 in parallel. For example, additional pump 120 may be in series with pump 120-1 and/or additional pump 120 may be in series with pump 120-2. When two pumps 120 of similar performance are used, tandem pump operation can double the pressure. In some examples, two or more pumps 120 arranged in series may operate in phase.

Out of phase may refer to two or more control signals that are in phase relationship with each other such that one control signal is at (or near) its positive peak and the other control signal is at (or near) its negative peak. Pump 120-1 may operate according to a first control signal (generated by controller 114) and pump 120-2 may operate according to a second control signal (generated by controller 114). The first and second control signals may control pump 120-1 and pump 120-2, respectively, to operate out of phase with each other. Each of the first and second control signals may define a series of active states (e.g., first and second states). For example, each of the first and second control signals may include a waveform having a series of first states (one of high states or low states) and second states (one of low states or high states). The first state may indicate that the diaphragm element is moving in a first direction and the second state may indicate that the diaphragm element is moving in a second direction (opposite to the first direction). The first signal may indicate a first state during a first time period, followed by a second state during a second time period, followed by a first state during a third time period, followed by a second state during a fourth time period, and so on. The second signal may indicate a second state during the first period of time, followed by a first state during the second period of time, a second state during the third period of time, a first state during the fourth period of time, and so on.

The active valve 118 may be an electronically controlled valve. The active valve 118 may be electronically controlled by the controller 114. For example, the active valve 118 may be connected to the controller 114 and may receive a signal to transition the active valve 118 between an open position in which fluid flows through the active valve 118 and a closed position in which fluid is prevented from flowing through the active valve 118. In some examples, the active valve 118 includes a diaphragm and an annular member (e.g., an O-ring). In some examples, in the closed position, the flow path is obstructed by an interface between the diaphragm and the annular member. In some examples, in the open position, the diaphragm is associated with (e.g., disposed a distance from) the annular member, which allows fluid to flow through the active valve 118. The active valve 118 may be bi-directional. Each active valve 118 may be piezoelectric or electromagnetic diaphragm actuated. In some examples, the active valve 118 is disposed in a fluid passage 124 for evacuating the expandable member 104 (e.g., during a deflation cycle). In some examples, the active valve 118 may transition to a closed position to maintain (e.g., substantially maintain) pressure in the expandable member 104. In some examples, the active valve 118 may be switched to an open position to divert fluid back to the fluid reservoir 102, relieve pressure in the expandable member 104, and/or allow fluid to flow back to the expandable member 104. In some examples, the active valve 118 may be used to maintain (e.g., substantially maintain) a partial inflation pressure.

In some examples, the electronic pump assembly 106 includes a single active valve 118. In some examples, the electronic pump assembly 106 includes a plurality of active valves 118. In some examples, one or more additional active valves 118 may be in series with pump 120-1, pump 120-2, and/or pump 120-3. In some examples, an additional active valve 118 (e.g., a series of active valves 118) may be disposed in a portion of the fluid path connected to the fluid reservoir 102. In some examples, an additional active valve 118 (e.g., a series of active valves 118) may be disposed in the portion of the fluid path connected to the expandable member 104. These additional active valves 118 may reduce leakage when at maximum expansion pressure or partial expansion pressure.

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 may include a plurality of pressure sensors 130.

The pressure sensor 130 is configured to measure a pressure 172 of the expandable 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 frequency 176. Each pressure reading may be indicative of the pressure 172 of the inflatable member 104 at the time of the pressure reading.

The controller 114 (e.g., pressure controller 174) and pressure sensor 130 may regulate the pressure 172 of the expandable member 104. For example, a pressure increase (or spike) may occur upon a compression event of the expandable member 104. However, the pressure adjustment described herein may minimize or prevent injury to the patient or damage to the inflatable penile prosthesis 100. The pressure controller 174 may control the pressure 172 of the expandable member 104 based on a combination of one or more pumps 120 and one or more active valves 118.

For example, the pressure controller 174 may receive a pressure reading from the pressure sensor 130, and in response to the measured pressure 172 being greater than a threshold, the pressure controller 174 may activate the active valve 118 in an open position to divert a portion of the fluid from the expandable member 104 back to the fluid reservoir 102. In some examples, the threshold is a maximum pressure threshold 160-1. In some examples, the threshold is a maximum pressure threshold 160-2. In some examples, the threshold is a pressure value that is greater than the maximum pressure threshold 160-1 and/or the maximum pressure threshold 160-2. In some examples, the pressure controller 174 may cause the active valve 118 to be in the open position in response to the pressure 172 being greater than a threshold value for a particular period of time. For example, if the measured pressure 172 is above a threshold for more than a predetermined period of time, the pressure controller 174 switches the active valve 118 to the open position. In response to pressure 172 being detected as corresponding to a threshold (or being less than a threshold), pressure controller 174 may switch active valve 118 to a closed position.

In some examples, there may be a small amount of leakage through the one or more pumps 120, the one or more passive valves, and the one or more active valves 118, and during sexual activity, such leakage may increase as greater pressure rises. However, in response to the measured pressure 172 being less than the target pressure, the pressure controller 174 may activate one or more pumps 120 to transfer additional fluid to the expandable member 104 so that the target pressure may be achieved. In some examples, the target pressure is a pressure set by the patient.

In some examples, when the expandable member 104 is expanded to its target pressure (e.g., during sexual activity), the controller 114 may increase the pressure sensing frequency 176 at which the controller 114 receives pressure readings (e.g., the pressure 172 is measured at high speed intervals during sexual activity). For example, the controller 114 may include a pressure sensing frequency controller 180 configured to control (e.g., adjust) the pressure sensing frequency 176. In some examples, the pressure sensing frequency controller 180 sets the pressure sensing frequency 176 to a first value (e.g., a higher pressure sensing frequency 176) in response to the inflation cycle being activated, the pressure 172 in the inflatable member 104 being near or at a target pressure, and/or detection of an activity level 186 and/or an activity type 190 of an indicative activity. The activity level 186 and/or activity type 190 may be determined based on information obtained via the accelerometer 154, as will be explained in later disclosure. In some examples, the pressure sensing frequency controller 180 may adjust the pressure sensing frequency 176 to a second value (e.g., a lower pressure sensing frequency 176) in response to a deflation cycle being activated, the pressure 172 in the inflatable member 104 being relatively low (e.g., at a partial inflation threshold 162-1 or 162-2, or at 0 PSI). For example, when the expandable member 104 is not expanded (or not expanded to its target pressure), the pressure sensing frequency controller 180 may decrease the pressure sensing frequency 176 so that electrical power and battery energy may be saved.

In some examples, the electronic pump assembly 106 may include additional pressure sensors 130, which may be located at various locations in the electronic pump assembly 106. For example, a pressure sensor 130 may be disposed between the active valves 118. In some examples, the pressure sensor 130 may be disposed between two pumps 120 connected in series. In some examples, the pressure sensor 130 may be disposed between two pumps 120 connected in parallel. In some examples, the pressure sensor 130 may be disposed between the active valve 118 and the pump 120. In some examples, pressure sensor 130 may be connected to fluid reservoir 102 and measure a pressure of fluid reservoir 102. One or more pressure sensors 130 are communicatively coupled to the controller 114 such that the controller 114 may receive signals from the pressure sensors 130. In some examples, pressure sensor 130 is configured to sense an amount of fluid transferred to inflatable member 104 and send one or more signals to controller 114 indicating the amount of fluid that has been transferred.

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

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

For example, the controller 114 may include an inflation controller 194 configured to control nighttime and/or random erection. Nocturnal penile swelling is spontaneous erection of the penis during sleep or wake-up, and may contribute to penile health. Night erection may be achieved by the expansion controller 194 to give the patient a more realistic experience. In some examples, the inflation controller 194 may cause the inflatable member 104 to inflate at one or more times during a period of the night (e.g., 3 to 6 a.m.) at a set (or random) time. In some examples, the inflation controller 194 may cause the inflatable member 104 to inflate to a random pressure threshold, which may be stored at the inflation controller 194 (and may be changed by a user using the external device 101). In some examples, the inflation controller 194 may receive the activity type 190 from the activity type detector 188 to confirm that the user is sleeping, and the inflation controller 194 may control the one or more pumps 120 and the one or more active valves 118 to inflate the inflatable member 104. In some examples, the inflation controller 194 may control one or more pumps 120 (e.g., pump 120-1 and pump 120-2) to operate at a lower frequency and/or lower pumping rate so as not to wake the patient (e.g., at a frequency and/or pumping rate lower than that used during the patient-initiated inflation cycle).

In some examples, the inflation controller 194 may cause the inflatable member 104 to inflate (e.g., randomly erect) at random times of the day. In some examples, inflation controller 194 may receive activity type 190 from activity type detector 188 (or activity level 186 from activity level detector 184) to ensure that the user is not engaged in an activity such as exercise, and then continue to activate one or more pumps 120 (e.g., pump 120-2) to inflate inflatable member 104. In some examples, the expansion controller 194 may expand the expandable member 104 to a random pressure threshold. In some examples, the time of the night and/or random erection may be controlled by the patient, e.g., the patient may select an appropriate time for the night and/or random erection to occur.

In some examples, the controller 114 may include a test cycle controller 192 configured to control inflation and deflation cycles after the inflatable penile prosthesis 100 has been implanted in a patient. For example, a healing cycle is required after the inflatable penile prosthesis 100 has been implanted into the body. After the healing period, the patient may be instructed to begin cycling their device through inflation and deflation. However, according to embodiments described herein, the test cycle controller 192 may implement intelligent processes that automatically implement inflation/deflation cycles in controlled increments. For example, the test cycle controller 192 may iteratively initiate an inflation cycle and a deflation cycle during a test duration (e.g., during one or more days, one or more weeks, one or more months). In some examples, the test duration includes a series of sub-durations (e.g., four one week periods) in which inflation and deflation settings are adjusted. For example, at each subsequent sub-duration, the pressure 172 in the expandable member 104 is adjusted (e.g., increased).

For example, during a first sub-duration, the test cycle controller 192 may expand the expandable member 104 to a first pressure, maintain the expandable member 104 at the first pressure, and then deflate the expandable member 104. In some examples, when activated, the test cycle controller 192 controls the timing of inflation and deflation and when to deflate. In some examples, the test cycle controller 192 may set the target pressure to the first pressure and the user is allowed to control inflation, deflation, and timing, but the maximum pressure is the first pressure. During a second sub-duration (e.g., the next week), the test cycle controller 192 may expand the expandable member 104 to a second pressure, maintain the expandable member 104 at the second pressure, and then deflate the expandable member 104. In some examples, the second pressure is higher than the first pressure. In some examples, when activated, the test cycle controller 192 controls the timing of inflation and deflation and when to deflate. In some examples, the test cycle controller 192 may set the target pressure to the second pressure and the user is allowed to control inflation, deflation, and timing, but the maximum pressure is the second pressure. During the third sub-duration, the test cycle controller 192 may expand the expandable member 104 to a third pressure, maintain the expandable member 104 at the third pressure, and then deflate the expandable member 104. In some examples, the third pressure is higher than the second pressure. In some examples, when activated, the test cycle controller 192 controls the timing of inflation and deflation and when to deflate. In some examples, the test cycle controller 192 may set the target pressure to a third pressure and the user is allowed to control inflation, deflation, and timing, but the maximum pressure is the second pressure.

During each sub-duration, the test period controller 192 may perform a number of iterations. Further, the test period controller 192 may control the timing of when each iteration is to be initiated. For example, after a first iteration, test cycle controller 192 may wait a first period of time before initiating a second iteration, then wait a second period of time before initiating a third iteration, and so on. The time between iterations may be the same or may be different (e.g., the time between iterations may decrease as the number of iterations increases, or the time between iterations may increase as the number of iterations increases). Further, at each iteration, the test cycle controller 192 may control the amount of time the expandable member 104 is held at the respective pressure (e.g., decrease the time between the expansion and contraction cycles as the number of iterations increases, or increase the time between the expansion and contraction cycles as the number of iterations increases).

The electronic pump assembly 106 may include a temperature sensor 152 configured to measure a temperature 191 of the fluid in the electronic pump assembly 106. In some examples, temperature sensor 152 is included as part of pressure sensor 130. In some examples, temperature sensor 152 is a separate sensor from pressure sensor 130. The temperature sensor 152 may be connected to a portion of the fluid channel in the electronic pump assembly 106. In response to the measured temperature 191 being greater than the threshold, the controller 114 may send a notification message 198 to one or more external devices 101 over the network via the antenna 112. For example, controller 114 may include a notification generator 196 configured to generate a notification message 198 to be sent to one or more external devices 101. The notification message 198 may indicate an alert regarding the health of the patient, the use of the inflatable penile prosthesis 100, and/or the high level of temperature 191. When the measured temperature 191 is greater than the threshold, the notification generator 196 may generate a notification message 198. The notification message 198 may be sent to the patient's device and/or a device associated with the doctor. Temperature 191 having a value exceeding a threshold level may be an indication of infection around the implanted device or possible failure of the device.

The controller 114 may detect performance problems associated with the inflatable penile prosthesis 100 based on pressure readings from the pressure sensor 130. For example, a leak (e.g., a leak event) may be detected based on pressure readings from the pressure sensor 130. Further, the performance of the pump and active valve may be inferred from pressure readings from the pressure sensor 130. For example, the pressure reading may indicate that the one or more pumps 120 and/or the one or more active valves 118 are not operating properly. In some examples, the controller 114 may detect a performance issue if the pump spends more than a threshold amount of time reaching a particular pressure. For example, the controller 114 may use pressure readings from the pressure sensor 130 and a time scale to detect performance problems with one or more pumps. In response to detecting a performance issue based on the pressure reading, notification generator 196 may send a notification message 198 over the network to one or more external devices 101, wherein notification message 198 may indicate that penile prosthesis 100 has one or more performance issues.

The electronic pump assembly 106 may include one or more sensors 158 configured to monitor the performance of the battery 116, the controller 114, the accelerometer 154, the heart rate monitor 156, and/or other electronics on the electronic pump assembly 106. Based on the data received via the one or more sensors 158, the controller 114 may determine whether one or more performance metrics 193 associated with the battery 116, the controller 114, the accelerometer 154, the heart rate monitor 156, and/or other electronics have not reached a target threshold. If the performance metric 193 does not reach the target threshold, the notification generator 196 may generate and send a notification message 198 to one or more external devices 101 over the network, wherein the notification message 198 may indicate a performance issue for one of the electronics on the electronic pump assembly 106.

The electronic pump assembly 106 may include a heart rate monitor 156 configured to monitor the heart rate of a user of the inflatable penile prosthesis 100. In some examples, the controller 114 is configured to record heart rate data 166 and store the heart rate data on the memory device 115. In some examples, heart rate data 166 may include information regarding the heart rate when inflatable member 104 is inflated and/or during sexual activity. In some examples, heart rate data 166 may correlate pressure 172 from the pressure readings to a heart rate of the user. In some examples, heart rate data 166 may correlate pressure fluctuations (received from pressure sensor 130) with heart rate. In some examples, heart rate data 166 may correlate acceleration 182 in acceleration readings from accelerometer 154 to a heart rate. The controller 114 may periodically send heart rate data 166 to one or more external devices 101.

The controller 114 may partially expand the expandable member 104 such that the pressure 172 of the expandable member 104 does not exceed a threshold (e.g., 0 PSI). For example, the controller 114 may include a partial expansion controller 195 that controls one or more pumps 120 and one or more active valves to expand the expandable member 104 such that the expandable member 104 does not exceed a threshold (e.g., 0 PSI). The inflatable member 104 may be empty or full, both at 0PSI. In some examples, the partial expansion controller 195 may actuate the active valve 118 to a closed position and cause the one or more pumps 120 to operate to fill the expandable member 104 with fluid, but still maintain the pressure 172 at 0PSI (or substantially around 0PSI (e.g., one or two PSI)). The inflatable penile prosthesis 100 may maintain the pressure with partial inflation in equilibrium under static conditions and no leakage occurs due to the absence of a pressure differential.

In some examples, fill pump 120 (e.g., pump 120-1, pump 120-2) is forward biased. In the event that a positive pressure differential exists between the fluid reservoir 102 and the expandable member 104, some fluid (e.g., leakage fluid) may move through one or more passive valves of the respective pump 120. For example, this may occur during certain gym exercises and other exercises in which abdominal pressure may be applied to the fluid reservoir. The forward pressure of the pump by the forward bias may cause pressure to build up into the expandable member 104, which may cause an unexpected partial expansion of the patient.

The controller 114 may include a pressure relief controller 168 configured to coordinate activation of an evacuation pump (e.g., pump 120-3) and/or opening of the active valve 118 with pressure pulsations 170. The pulsation 170 may be measured by the pressure sensor 130. Pulsation 170 may be a short increase in pressure 172. Just after the pulsation 170, the pressure relief controller 168 may time the opening of the active valve 118 to relieve the pressure 172 from the expandable member 104. The active valve 118 is then closed before the next pulse 170. For example, pressure relief controller 168 may obtain pressure readings from pressure sensor 130 over time as a function of pressure sensor frequency 176. The pressure release controller 168 may detect the first pressure pulsation 170-1 at a first time and the second pressure pulsation 170-2 at a second time. The pressure relief controller 168 may cause the active valve 118 to be in an open position after a first time (and, in some examples, activate the pump 120-3). In some examples, pressure relief controller 168 actuates pump 120-3 at a frequency that is lower than the frequency used to drive pump 120-3 during a normal deflation cycle. The pressure relief controller 168 may cause the active valve 118 to be in the closed position (and, in some examples, deactivate the pump 120-3) before the second time.

The pressure relief controller 168 may empty fluid from the expandable member 104 after a high activity period by causing the active valve 118 to be in an open position and, in some examples, causing the pump 120-3 to operate. For example, as described above, forward pressure by forward biasing the pump may cause pressure to build up into the expandable member 104, which may cause an unintended partial expansion of the patient. However, pressure relief controller 168 may receive pressure readings from pressure sensor 130 as well as activity level 186 and/or activity type 190. For example, during a first period of time, activity level 186 may be relatively high, indicating an activity type 164-1 of exercise. During the second period of time, the activity level 186 may be relatively low, indicating the type of activity 164-2 at rest. In some examples, at the end of the first period (or at the beginning of the second period), pressure relief controller 168 may open active valve 118 and actuate pump 120-3. In some examples, pressure relief controller 168 may drive pump 120-3 at a frequency that is lower than the frequency used during the deflation cycle.

The electronic pump assembly 106 may include a sealed enclosure 108 that encloses the components of the electronic pump assembly 106. The sealed enclosure 108 may be a hermetically sealed (or substantially hermetically sealed) 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, the only material in contact with the patient is titanium. In some examples, sealed enclosure 108 defines a feedthrough 140 (e.g., sealed feedthrough, electrical feedthrough, feedthrough connector, etc.) to receive wireless signals from/transmit wireless signals to external device 101. In some examples, feedthrough 140 includes a metal-based material and an insulator-based material (e.g., ceramic).

The electronic pump assembly 106 may include a sealed fluid chamber 110 disposed within a 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, a portion of the sealed fluid chamber 110 is a metal-based material (e.g., titanium) and a portion of the sealed fluid chamber 110 is a non-metal-based material (e.g., ceramic). Sealing the fluid chamber 110 may isolate the fluid from electronics (e.g., the controller 114, the accelerometer 154, the heart rate monitor 156, one or more sensors 158, the battery 116, etc.). In other words, the electronics section may be fluidly isolated (e.g., completely isolated) from the sealed fluid chamber 110. The sealed fluid chamber 110 may be fluidly connected to the fluid reservoir 102 and the expandable member 104. The sealed fluid chamber 110 may include one or more active valves 118, one or more pumps 120, one or more pressure sensors 130, and a temperature sensor 152. In some examples, sealed fluid chamber 110 defines a feedthrough 138 (e.g., sealed feedthrough, electrical feedthrough, feedthrough connector, etc.) to controller 114 to receive signals from/send signals to controller 114. In some examples, the sealed fluid chamber 110 disposed within the sealed enclosure 108 creates a double seal system. In some examples, the electronic pump assembly 106 includes only one sealed enclosure (e.g., sealed enclosure 108).

Fig. 2A illustrates an electronic pump assembly 206 according to one aspect. Fig. 2B illustrates a check valve 221 disposed in series with one of the pumps 220, according to one aspect. Fig. 2C shows a check valve 221 disposed in series with one of the pumps 220 according to another aspect. The electronic pump assembly 206 may be an example of the electronic pump assembly 106 of fig. 1A and 1B, and may include any of the details described with reference to these figures.

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

Pumps 220-1 and 220-2 are electronically controlled pumps. Pumps 220-1 and 220-2 may be electronically controlled by a controller (e.g., controller 114 of fig. 1A and 1B). In some examples, pumps 220-1 and 220-2 are unidirectional, in that pumps 220-1 and 220-2 may transfer fluid from fluid reservoir 202 to inflatable member 204. However, in some examples, pumps 220-1 and 220-2 are bi-directional. In some examples, pump 220-1 or pump 220-2 is an electromagnetic pump or a piezoelectric pump.

Either pump 220-1 or pump 220-2 may include a passive check valve 223 and a passive check valve 225. The passive check valve 223 and the passive check valve 225 may help maintain pressure in the expandable member 204. Pump 220-1 may be disposed in parallel with active valve 218. Pump 220-2 may be disposed in parallel with pump 220-1. In some examples, using two pumps in parallel (e.g., pump 220-1, pump 220-2) may increase the amount of fluid that can be transferred to the inflatable member 204. In some examples, pump 220-1 and pump 220-1 may operate out of phase with each other in order to increase the efficiency of electronic pump assembly 206. In some examples, two parallel pumps (e.g., pump 220-1, pump 220-2) operating out of phase (e.g., 180 degrees out of phase) with each other may allow the output pressure of pump 220-1 to increase the valve closure of pump 220-2, thereby increasing overall performance (and vice versa). In some examples, using parallel pumps (e.g., pump 220-1, pump 220-2) that operate out of phase with each other may allow pump 220-1 and pump 220-2 to operate at lower frequencies, which may reduce electrical power (and thus extend battery life). In addition, a smoother flow rate may also be achieved, thereby reducing vibration and improving patient experience.

The active valve 218 may be an electronically controlled valve. The active valve 218 may be electronically controlled by a controller (e.g., the controller 114 of fig. 1A and 1B). For example, the active valve 218 may receive a signal to transition the active valve 218 between an open position in which fluid flows through the active valve 218 and a closed position in which fluid is prevented from flowing through the active valve 218. In some examples, the active valve 218 may transition to a closed position to maintain (e.g., substantially maintain) pressure in the expandable member 204. In some examples, the active valve 218 may be switched to an open position to divert fluid back to the fluid reservoir 202, relieve pressure in the expandable member 204, and/or allow fluid to flow back to the expandable member 204. In some examples, the active valve 218 may be used to maintain (e.g., substantially maintain) a partial inflation pressure.

The pressure sensor 230 is configured to measure the pressure of the expandable member 204. The pressure sensor 230 may be coupled to a portion of a fluid channel connected to the expandable member 204. In some examples, the pressure sensor 230 may be coupled to a portion of the fluid passage between the active valve 218 and the expandable member 204. In some examples, pressure sensor 230 may be coupled to a portion of the fluid path between pump 220-1 and inflatable member 204. In some examples, pressure sensor 230 may be coupled to a portion of the fluid path between pump 220-2 and inflatable member 204. The pressure sensor 230 is communicatively coupled to a controller (e.g., the controller 114 of fig. 1A and 1B) such that the controller can receive signals from the pressure sensor 230.

In some examples, as shown in fig. 2B and 2C, the electronic pump assembly 206 may include a check valve 221 disposed in series with the pump 220 (where the pump 220 may be either the pump 220-1 or the pump 220-2 or both). In some examples, as shown in fig. 2B, a check valve 221 is disposed between the pump 220 and the expandable member 204. In some examples, as shown in fig. 2C, a check valve 221 is disposed between the pump 220 and the fluid reservoir 202. The check valve 221 may define a cracking pressure (cracking pressure) 227. When the pressure differential between the inlet of the check valve 221 and the outlet of the check valve 211 is greater than the cracking pressure 227, the check valve 221 is configured to open to allow fluid to pass. When the pressure differential between the inlet of the check valve 221 and the outlet of the check valve 211 is less than the cracking pressure 227, the check valve 221 is configured to close, thereby blocking the transfer of fluid. In some examples, the cracking pressure 227 is in the range of 1.0PSI to 5.0 PSI. In some examples, the cracking pressure 227 is in the range of 2.0PSI to 4.0 PSI. In some examples, the cracking pressure 227 is 3.0PSI. The check valve 221 disposed in series with the pump 220 may reduce leakage or unintended flow from the fluid reservoir 202 to the expandable member 204 during activities in which abdominal pressure is exerted on the fluid reservoir 202. In some examples, the check valve 221 is closed during periods of normal non-erection and ensures that unintentional partial erection is minimized.

Fig. 3 illustrates an electronic pump assembly 306 in accordance with an aspect. The electronic pump assembly 306 may be an example of the electronic pump assembly 106 of fig. 1A and 1B and/or the electronic pump assembly 206 of fig. 2A-2C, and may include any of the details described with reference to these figures. The electronic pump assembly 306 may be the same (similar) as the electronic pump assembly 206 of fig. 2A-2C, except that an evacuation pump (e.g., pump 320-3) is included on the electronic pump assembly 306.

Electronic pump assembly 306 includes active valve 318, pump 320-1, pump 320-2, pump 320-3, and pressure sensor 230. Pump 320-1 may include an inlet and an outlet. The inlet of pump 320-1 may be fluidly connected to fluid reservoir 302 and the outlet of pump 320-1 may be fluidly connected to inflatable member 304. Pump 320-2 may include an inlet and an outlet. The inlet of pump 320-2 may be fluidly connected to fluid reservoir 302 and the outlet of pump 320-2 may be fluidly connected to inflatable member 304. Pump 320-3 may include an inlet and an outlet. The inlet of pump 320-3 may be fluidly connected to the inflatable member and the outlet of pump 320-3 may be fluidly connected to active valve 318 (and fluid reservoir 302). The active valve 318 may include an inlet and an outlet. An inlet of the active valve 318 may be fluidly connected to an outlet of the pump 320-2 (and the inflatable member 304), and an outlet of the active valve 318 may be fluidly connected to the fluid reservoir 302.

Pumps 320-1, 320-2, and 320-3 are electronically controlled pumps. Pumps 320-1, 320-2, and 320-3 may be electronically controlled by a controller (e.g., controller 114 of fig. 1A and 1B). In some examples, pumps 320-1 and 320-2 are unidirectional, in that pumps 320-1 and 320-2 may transfer fluid from fluid reservoir 302 to inflatable member 304. In some examples, pump 320-3 is unidirectional in that pump 320-3 may transfer fluid from expandable member 304 to fluid reservoir 302. However, in some examples, pumps 320-1, 320-2, and 320-3 are bi-directional. In some examples, pumps 320-1, 320-2, and 320-3 may be electromagnetic or piezoelectric pumps.

Pump 320-1, pump 320-2, or pump 320-3 may include a passive check valve 323 and a passive check valve 325. The passive check valve 323 and the passive check valve 325 may help maintain pressure in the expandable member 304. Pump 320-1 may be disposed in parallel with active valve 318. Pump 320-2 may be disposed in parallel with pump 320-1. Pump 320-3 may be disposed in series with active valve 318. Pump 320-3 may be disposed in parallel with pump 320-1 or pump 320-2.

Fig. 4 illustrates an example of a portion of an electronic pump assembly 406 according to one aspect. Electronic pump assembly 406 may be an example of electronic pump assembly 106 of fig. 1A and 1B, electronic pump assembly 206 of fig. 2A-2C, and/or electronic pump assembly 306 of fig. 3, and may include any of the details described with reference to these figures.

The electronic pump assembly 406 is configured to transfer fluid between the fluid reservoir 402 and the expandable member 404. The electronic pump assembly 406 may transfer fluid between the fluid reservoir 402 and the expandable member 404 automatically without requiring a user to manually operate the pump (e.g., squeeze and release the pump bubbles).

The electronic pump assembly 406 includes a pump 420-1 disposed within a fluid passage 424 (e.g., a fill passage) and an active valve 418 disposed within a fluid passage 427 (e.g., an empty passage). The 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. The fluid channels 427 may be fluid branches that are separate (and parallel) from the fluid channels 424. The fluid channel 427 is a channel that transfers fluid from the fluid reservoir 402 to the expandable member 404. Fluid passageway 424 is the passageway that transfers fluid from expandable member 404 to fluid reservoir 402. Pump 420-1 is disposed in parallel with active valve 418.

In some examples, the electronic pump assembly 406 may include an active valve 419 in series with the pump 420-1 (e.g., the pump 420-1 and the active valve 419 are disposed within the fluid channel 427). In some examples, electronic pump assembly 406 may include a pump 420-2 in series with an active valve 418 (e.g., pump 420-2 and active valve 418 are disposed in fluid channel 424). The pump 420-2 may be an electromagnetic pump or a piezoelectric pump. Pump 420-2 may include a passive check valve 423 and a passive check valve 425. In some examples, the electronic pump assembly 406 includes an active valve 448 that is fluidly connected to the fluid reservoir 402. The active valve 448 may be in series with either the active valve 418 (and the pump 420-2) or the pump 420-1 (and the active valve 419). In some examples, the electronic pump assembly 406 includes an active valve 452 fluidly connected to the expandable member 404. Active valve 452 may be in series with either active valve 419 (and pump 420-1) or pump 420-2 (and active valve 418).

The active valve 448, pump 420-1, active valve 418, active valve 452, active valve 418, and pump 420-2 may be electronically controlled by a controller and/or driver (e.g., controller 114 of fig. 1A and 1B). Pumps 420-1 and 420-2 may be unidirectional or bidirectional. With respect to the fluid channel 427, in some examples, the pump 420-1 and the active valve 419 may exchange positions (e.g., where the active valve 419 is connected in series between the active valve 448 and the pump 420-1). With respect to fluid passage 424, in some examples, active valve 418 and pump 420-2 may exchange positions (e.g., where pump 420-1 is connected in series between active valve 418 and active valve 448).

In some examples, one or more additional active valves and/or one or more additional pumps are disposed in series within the fluid channel 427. In some examples, one or more additional active valves and/or one or more additional pumps are disposed in series within fluid channel 424. In some examples, the electronic pump assembly 406 may include one or more additional (and parallel) fluid channels, where each additional (and parallel) fluid channel may include one or more active valves and one or more pumps.

In some examples, the electronic pump assembly 406 may include a pressure sensor 430 and a pressure sensor 431. The pressure sensors 430 and 431 are connected to a controller (e.g., the controller 114 of fig. 1A and 1B), where the controller receives measured pressures from the pressure sensors 430 and 431.

The pressure sensor 430 is configured to measure the pressure in the expandable member 404. The controller may receive the measured pressure from the pressure sensor 430 and automatically control the active valve and/or pump to regulate the pressure. In some examples, pressure sensor 431 is configured to measure pressure in fluid reservoir 402. In some examples, pressure sensor 431 may detect intra-abdominal pressure (which may increase during an activity such as exercise), and the controller may 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 at other locations within the electronic pump assembly 406. For example, a pressure sensor may be disposed between the active valve 448 and the pump 420-1. In some examples, a pressure sensor may be disposed between the pump 420-1 and the active valve 419. In some examples, a pressure sensor may be disposed between the active valve 448 and the active valve 418. In some examples, a pressure sensor may be disposed between the active valve 418 and the pump 420-2.

Fig. 5 schematically illustrates an inflatable penile prosthesis 500 with an electronic pump fitment 506 according to one aspect. Electronic pump assembly 506 can include any of the features of the electronic pump assemblies (e.g., 106, 206, 306, 406) and inflatable penile prostheses (e.g., 100, 200) described herein. Inflatable penile prosthesis 500 may include a pair of inflatable cylinders 510, and inflatable cylinders 510 are configured to be implanted in the penis. For example, one of the inflatable cylinders 510 may be disposed on one side of the penis and the other inflatable cylinder 510 may be disposed on the other side of the penis. Each inflatable cylinder 510 may include a first end 524, a cavity or inflation chamber 522, and a second end 528 having a rear tip 532.

At least a portion of the electronic pump assembly 506 may be implanted within the patient. A pair of conduit connectors 505 may attach the electronic pump fitting 506 to the inflatable cylinder 510 such that the electronic pump fitting 506 is in fluid communication with the inflatable cylinder 510. Further, the electronic pump fitting 506 may be in fluid communication with the fluid reservoir 550 via the conduit connector 503. The fluid reservoir 550 may be implanted in the abdomen of the user. The inflation chamber 522 of the inflatable cylinder 510 may be disposed within the penis. The first end 524 of the inflatable cylinder 510 may be at least partially disposed within the crown of the penis. The second end 528 may be implanted into a pubic region PR of the patient with the posterior tip 532 proximate to the pubic bone PB.

To implant inflatable cylinder 510, the surgeon first prepares the patient. The surgeon often makes an incision in the penile area, for example, where the base of the penis meets the top of the scrotum. From the penile incision, the surgeon may dilate the patient's corpus cavernosum to prepare the patient to receive inflatable cylinder 510. The corpus cavernosum is one of two parallel erectile tissue columns forming the rear part of the penis body, e.g. two elongated columns extending substantially the length of the penis. The surgeon will also dilate both areas of the pubic region to prepare the patient to receive second end 528. The surgeon may measure the length of the expanded region of the corpus cavernosum from the incision to the pubic region to determine the proper size of the inflatable cylinder 510 to be implanted.

After the patient is ready, penile prosthesis 500 is implanted within the patient. The tip of the first end 524 of each inflatable cylinder 510 may be attached to a suture. The other end of the suture may be attached to a needle member (e.g., a Keith needle). The needle member is inserted into the incision and into the distended corpus cavernosum. The needle member is then forced through the crown of the penis. The surgeon pulls the suture to pull the inflatable cylinder 510 into the sponge. This is done for each of the pair of inflatable cylinders 510. Once the expansion chamber 522 is in place, the surgeon may remove the suture from the tip. The surgeon then inserts second end 528. The surgeon inserts the rear ends of the inflatable cylinders 510 into the incision and forces the second ends 528 toward the pubic bone PB until each inflatable cylinder 510 is in place.

The user may use external device 501 to control inflatable penile prosthesis 500. In some examples, the user may use the external device 501 to inflate or deflate the inflatable cylinder 510. For example, in response to a user activating an inflation cycle using external device 501, external device 501 may send a wireless signal to electronic pump assembly 506 to initiate an inflation cycle to transfer fluid from fluid reservoir 550 to inflatable cylinder 510. In some examples, in response to a user activating a deflation cycle using external device 501, external device 501 may send a wireless signal to electronic pump assembly 506 to initiate a deflation cycle to transfer fluid from inflatable cylinder 510 to fluid reservoir 550. In some examples, during the deflation cycle, fluid is transferred back until the pressure in inflatable cylinder 510 reaches a partial inflation pressure.

Figure 6 illustrates a flowchart 600 describing example operations of a method of operating an electronic pump assembly of an inflatable penile prosthesis. The example operations of flowchart 600 may be performed by any of the inflatable penile prostheses and/or electronic pump accessories (e.g., 106, 206, 306, 406, 506) described herein.

Operation 602 includes receiving, by an antenna of the electronic pump assembly, a wireless control signal from an external device. Operation 604 includes activating, by the controller, a pump of the electronic pump assembly to operate to transfer fluid from the fluid reservoir to the expandable member in response to the wireless control signal such that a pressure of the expandable member reaches a threshold. Operation 606 comprises measuring, by a pressure sensor, a pressure of the expandable member. Operation 608 includes activating, by the controller, an active valve of the electronic pump assembly in an open position to transfer a portion of the fluid from the expandable member to the fluid reservoir in response to the measured pressure being greater than a threshold. In some examples, the operations include detecting, by the controller, that the measured pressure corresponds to a threshold. In some examples, the operations include activating, by the controller, the active valve in the closed position in response to the measured pressure being detected as corresponding to the threshold.

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

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

Embodiments relate generally to body implants. Hereinafter, the term "patient" or "user" may be used for a person who benefits from the medical devices or methods disclosed in the present disclosure. For example, the patient may be a person whose body is implanted with the medical device or a method for operating the medical device disclosed by the present disclosure. For example, in some embodiments, the patient may be a human.

While certain features of the described embodiments have been illustrated as described herein, many modifications, substitutions, changes, and equivalents will now occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the scope of the embodiments.

Claims

1. An inflatable penile prosthesis comprising:

a fluid reservoir configured to contain a fluid;

an inflatable member; and

An electronic pump assembly configured to transfer the fluid between the fluid reservoir and the expandable member, the electronic pump assembly comprising:

A pump;

An active valve;

a pressure sensor configured to measure a pressure of the expandable member; and

A controller configured to control at least one of the pump or the active valve based on the measured pressure.

2. The inflatable penile prosthesis according to claim 1, wherein the controller is configured to: the active valve is caused to be in an open position to transfer a portion of the fluid from the expandable member to the fluid reservoir in response to the measured pressure being greater than a threshold value.

3. The inflatable penile prosthesis according to claim 1 or 2, wherein the controller is configured to: the pump is caused to operate to transfer a portion of the fluid from the fluid reservoir to the expandable member in response to the measured pressure being less than a threshold.

4. An inflatable penile prosthesis according to any of claims 1-3, wherein the fluid reservoir comprises a pressure-regulating flexible member configured to cause the inflatable member to be partially inflated without operation of the pump.

5. The inflatable penile prosthesis according to any of claims 1-4, wherein the electronic pump assembly comprises an accelerometer configured to measure acceleration of a user of the inflatable penile prosthesis.

6. The inflatable penile prosthesis according to claim 5, wherein the controller is configured to identify a sleep mode of a user of the inflatable penile prosthesis based on the measured acceleration, the controller configured to cause the inflatable member to at least partially inflate while the user is sleeping.

7. The inflatable penile prosthesis according to any of claims 1-6, wherein the electronic pump assembly comprises a heart rate sensor configured to monitor a heart rate of a user of the inflatable penile prosthesis.

8. The inflatable penile prosthesis according to any of claims 1-7, wherein the electronic pump assembly comprises a temperature sensor configured to measure a temperature of the fluid.

9. The inflatable penile prosthesis according to any of claims 1-8, wherein the controller is configured to: an inflation cycle and a deflation cycle are iteratively initiated during a test duration defining a series of sub-durations, wherein at each subsequent sub-duration, the pressure in the inflatable member is adjusted.

10. The inflatable penile prosthesis according to any of claims 1-9, wherein the controller is configured to partially inflate the inflatable member such that the pressure of the inflatable member does not exceed a partial pressure threshold, wherein in response to a wireless signal, the controller is configured to inflate the inflatable member to a maximum pressure threshold during an inflation cycle.

11. The inflatable penile prosthesis according to any of claims 1-10, wherein the controller comprises a memory configured to: storing at least one of a maximum pressure threshold or a partial pressure threshold, the controller configured to: the value of at least one of the maximum pressure threshold or the partial pressure threshold is updated based on information received from an external device via an antenna of the electronic pump assembly.

12. The inflatable penile prosthesis according to any of claims 1-11, wherein the controller is configured to: detecting a performance problem associated with the inflatable penile prosthesis based on pressure readings from the pressure sensor, the controller configured to: a notification message is sent over the network to one or more external devices in response to the performance issue being detected.

13. The inflatable penile prosthesis according to any of claims 1-12, wherein the controller is configured to: obtaining pressure readings from the pressure sensor over time as a function of pressure sensor frequency, wherein the controller is configured to: a first pressure pulsation is detected at a first time and a second pressure pulsation is detected at a second time, wherein the controller is configured to cause the active valve to be in an open position after the first time, wherein the controller is configured to cause the active valve to be in a closed position before the second time.

14. A method of operating an inflatable penile prosthesis, the method comprising:

receiving, by an antenna of the electronic pump assembly, a wireless control signal from an external device;

Activating, by a controller, a pump of the electronic pump assembly to operate to transfer fluid from a fluid reservoir to an inflatable member in response to the wireless control signal such that a pressure of the inflatable member reaches a threshold;

Measuring the pressure of the expandable member by a pressure sensor; and

Activating, by the controller, an active valve of the electronic pump assembly in an open position to transfer a portion of the fluid from the expandable member to the fluid reservoir in response to the measured pressure being greater than the threshold.

15. The method of claim 14, further comprising:

detecting, by the controller, that the measured pressure corresponds to the threshold; and

The active valve is activated by the controller in a closed position in response to the measured pressure being detected as corresponding to the threshold.

16. An inflatable penile prosthesis comprising:

a fluid reservoir configured to hold a fluid;

an inflatable member; and

A pump;

An active valve;

17. The inflatable penile prosthesis according to claim 16, wherein the controller is configured to cause the active valve to be in an open position to transfer a portion of the fluid from the inflatable member to the fluid reservoir in response to the measured pressure being greater than a threshold value.

18. The inflatable penile prosthesis according to claim 16, wherein the controller is configured to cause the pump to operate to transfer a portion of the fluid from the fluid reservoir to the inflatable member in response to the measured pressure being less than a threshold value.

19. The inflatable penile prosthesis according to claim 16, wherein the fluid reservoir includes a pressure-regulating flexible member configured to cause the inflatable member to be partially inflated without operation of the pump.

20. The inflatable penile prosthesis according to claim 16, wherein the electronic pump assembly includes an accelerometer configured to measure acceleration of a user of the inflatable penile prosthesis.

21. The inflatable penile prosthesis according to claim 20, wherein the controller is configured to identify a sleep mode of a user of the inflatable penile prosthesis based on the measured acceleration, the controller configured to cause the inflatable member to at least partially inflate while the user is sleeping.

22. The inflatable penile prosthesis according to claim 16, wherein the electronic pump assembly includes a heart rate sensor configured to monitor a heart rate of a user of the inflatable penile prosthesis.

23. The inflatable penile prosthesis according to claim 16, wherein the electronic pump assembly includes a temperature sensor configured to measure a temperature of the fluid.

24. The inflatable penile prosthesis according to claim 16, wherein the controller is configured to iteratively initiate an inflation cycle and a deflation cycle during a test duration defining a series of sub-durations, wherein at each subsequent sub-duration the pressure in the inflatable member is adjusted.

25. An inflatable penile prosthesis comprising:

a fluid reservoir configured to contain a fluid;

an inflatable member; and

An antenna configured to receive a wireless signal from an external device;

A pump;

An active valve;

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 a wireless signal.

26. The inflatable penile prosthesis according to claim 25, wherein the electronic pump assembly comprises: an accelerometer configured to measure acceleration of a user of the inflatable penile prosthesis; a controller configured to determine an activity type based on the measured acceleration, wherein the controller is configured to adjust a pressure sensing frequency associated with the pressure sensor based on the activity type.

27. The inflatable penile prosthesis according to claim 25, wherein the controller is configured to partially inflate the inflatable member such that the pressure of the inflatable member does not exceed a threshold, wherein in response to the wireless signal, the controller is configured to inflate the inflatable member to a maximum pressure threshold during an inflation cycle.

28. The inflatable penile prosthesis according to claim 25, wherein the electronic pump assembly comprises a temperature sensor configured to measure a temperature of the fluid, wherein in response to the measured temperature being greater than a threshold, the controller is configured to send a notification message to one or more external devices over a network via the antenna.

29. The inflatable penile prosthesis according to claim 25, wherein the controller comprises a memory configured to store at least one of a maximum pressure threshold or a partial pressure threshold, the controller configured to update a value of the at least one of the maximum pressure threshold or the partial pressure threshold based on information received from the external device via the antenna.

30. The inflatable penile prosthesis according to claim 25, wherein the controller is configured to detect a performance issue associated with the inflatable penile prosthesis based on pressure readings from the pressure sensor, the controller configured to send a notification message to one or more external devices over a network in response to the performance issue being detected.

31. The inflatable penile prosthesis according to claim 25, wherein the electronic pump assembly includes a battery configured to provide electrical power to the controller, the electronic pump assembly including a sensor configured to monitor a performance of the battery.

32. The inflatable penile prosthesis according to claim 25, wherein the controller is configured to obtain pressure readings from the pressure sensor over time as a function of pressure sensor frequency, wherein the controller is configured to detect a first pressure pulsation at a first time and a second pressure pulsation at a second time, wherein the controller is configured to cause the active valve to be in an open position after the first time, wherein the controller is configured to cause the active valve to be in a closed position before the second time.

33. The inflatable penile prosthesis according to claim 25, wherein the electronic pump assembly includes a check valve in series with the pump.

34. A method of operating an inflatable penile prosthesis, the method comprising:

Measuring the pressure of the expandable member by a pressure sensor; and

35. The method of claim 34, further comprising:

The active valve is activated in a closed position by the controller in response to the measured pressure being detected as corresponding to the threshold.