KR20240105463A - Electronically implantable penile prosthesis with pressure regulation and other functions - Google Patents

Abstract

According to one aspect, an inflatable penile prosthesis 100 includes a fluid reservoir 102 configured to retain fluid, an inflatable member 104, and an electronic pump assembly 106 configured to transfer fluid between the fluid reservoir and the inflatable member. ) includes. The electronic pump assembly includes a pump 120, an active valve 118, a pressure sensor 130 configured to measure the 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. 114).

Description

Electronically implantable penile prosthesis with pressure regulation and other functions

Cross-reference to related applications

This application is a continuation of and claims priority to U.S. Provisional Patent Application No. 18/068,108, entitled “ELECTRONIC IMPLANTABLE PENILE PROSTHESIS WITH PRESSURE REGULATION AND OTHER FUNCTIONS,” filed on December 19, 2022. Priority is claimed on U.S. Provisional Patent Application No. 63/265,812, entitled “ELECTRONIC IMPLANTABLE PENILE PROSTHESIS WITH PRESSURE REGULATION AND OTHER FUNCTIONS,” filed December 21, 2012, the disclosures of which are incorporated by reference in their entirety. Included herein.

This application also claims priority to U.S. Provisional Patent Application No. 63/265,812, filed December 21, 2021, the disclosure of which is incorporated herein by reference in its entirety.

technology field

This disclosure relates generally to body implants, and more specifically to body implants, such as electronic implantable penile prostheses with pressure regulation and other functions.

One treatment for male impotence is implanting a penile prosthesis that causes the penis to become erect. Some existing penile prostheses include an inflatable cylinder or member that can be inflated or deflated using a pump mechanism. The pump mechanism includes a pump implantable in the scrotum, which can be manually squeezed by the user to move fluid from the reservoir to the cylinder to produce an erection. For some patients, manual pumping procedures may be relatively difficult.

According to one aspect, an inflatable penile prosthesis includes a fluid reservoir configured to retain fluid, an inflatable member, and an electronic pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member. The electronic pump assembly includes a pump, an active valve, a pressure sensor configured to measure the pressure 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.

According to some embodiments, an inflatable penile prosthesis may include one or more of the following features (or any combination thereof): The controller is configured to cause the active valve to be in an open position to transfer a portion of 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 actuate 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 allow the expandable member to be partially inflated without activating 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 sleeping pattern 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 expand when the user is sleeping. The electronic pump assembly includes a heart rate sensor configured to monitor the heart rate of a user of the inflatable penile prosthesis. The electronic pump assembly includes a temperature sensor configured to measure the temperature of the fluid. The controller is configured to repeatedly initiate the expansion and contraction cycles over a period of time, with each subsequent repetition increasing the pressure of the expandable member.

According to one aspect, an inflatable penile prosthesis includes a fluid reservoir configured to retain fluid, an inflatable member, and an electronic pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member. The electronic pump assembly includes an antenna configured to receive a wireless signal from an external device, a pump, an active valve, a pressure sensor configured to measure the pressure of the inflatable member, and either the pump or the active valve based on at least one of the measured pressure or the wireless signal. and a controller configured to control at least one.

According to some embodiments, an inflatable penile prosthesis may include one or more of the following features (or any combination thereof): 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 the type of activity based on the measured acceleration, and the controller is configured to adjust the pressure sensing speed associated with the pressure sensor based on the type of activity. The controller is configured to partially expand the expandable member such that the pressure of the expandable member does not exceed the partial pressure threshold, and in response to the wireless signal, the controller is configured to inflate the expandable member to the maximum pressure threshold during the inflation cycle. It is composed of: The electronic pump assembly includes a temperature sensor configured to measure the temperature of the fluid, and in response to the measured temperature being greater than a threshold, the controller is configured to transmit a notification message to one or more external devices, via the network, via the antenna. do. The controller includes a memory configured to store at least one of the maximum pressure threshold or the partial pressure threshold, wherein the controller stores at least one of the maximum pressure threshold or the partial pressure threshold based on information received from the external device through the antenna. It is configured to update the value. The controller is configured to detect a performance problem associated with the inflatable penile prosthesis based on pressure readings from the pressure sensor, and the controller is configured to transmit a notification message to one or more external devices over the network in response to the performance problem being detected. do. The electronic pump assembly includes a battery configured to power the controller, and the electronic pump assembly includes a sensor configured to monitor performance of the battery. the controller is configured to obtain a pressure reading from the pressure sensor over time according to the pressure sensor rate, the controller is configured to detect a first pressure pulsation at a first time and a second pressure pulsation at a second time; The controller is configured to cause the active valve to be in the open position after the first time and to cause the active valve to be in the 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 receiving, by an antenna of an electronic pump assembly, a wireless control signal from an external device, activating, by a controller, a pump of the electronic pump assembly to operate the inflatable penile prosthesis. transferring fluid from the fluid reservoir to the inflatable member in response to a wireless control signal such that the pressure in the member reaches a threshold, measuring, by a pressure sensor, the pressure of the inflatable member, and, by the controller, measuring the pressure of the inflatable member. In response to the pressure being greater than a threshold, activating an active valve of the electronic pump assembly to an open position to transfer a portion of fluid from the expandable member to the fluid reservoir. In some examples, the method includes detecting, by the controller, whether the measured pressure corresponds to a threshold. In some examples, the method includes activating, by the controller, an active valve in a closed position in response to detecting, by the controller, that the measured pressure corresponds to a threshold.

1A illustrates an inflatable penile prosthesis with an electronic pump assembly according to one aspect.
1B illustrates a controller of an electronic pump assembly according to one aspect.
2A illustrates an inflatable penile prosthesis with an electronic pump assembly according to another aspect.
2B illustrates a check valve in series with a pump in an electronic pump assembly according to one aspect.
2C illustrates a check valve in series with a pump in an electronic pump assembly according to another aspect.
3 illustrates an example of an electronic pump assembly according to one aspect.
4 illustrates an example of an electronic pump assembly according to another aspect.
5 illustrates an inflatable penile prosthesis with an electronic pump assembly according to another aspect.
FIG. 6 illustrates a flow diagram illustrating exemplary operation of an electronic pump assembly according to one aspect.

The present disclosure relates to an inflatable penile prosthesis that includes an electronic pump assembly for transferring fluid between a fluid reservoir and an inflatable member. The electronic pump assembly may control the inflatable penile prosthesis (e.g., inflate or deflate the inflatable member) by wirelessly communicating with an external device (e.g., computer, smartphone, tablet, pendant, key fob, etc.). or updates one or more control parameters). The electronic pump assembly may include a primary battery (eg, a non-rechargeable battery) or a rechargeable battery configured to be recharged by an external charger.

An electronic pump assembly includes one or more pumps (eg, electronically controlled pumps, such as one or more electromagnetic or piezoelectric pumps), one or more active valves, and a controller. In some examples, the electronic pump assembly includes an accelerometer, a heart rate monitor, and one or more sensors that monitor the battery or other electronics of the electronic pump assembly. In some examples, the electronic pump assembly includes a temperature sensor.

The controller may actuate the pump(s) and active valve(s) to control inflation and deflation of the inflatable member based on control signals transmitted to the pump(s) and active valve(s). Pumps can 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, the pump(s) can deliver fluid to the inflatable member during an expansion cycle and the active valve can be switched to an open position to allow fluid to be delivered back toward the fluid reservoir during a deflation cycle. The pump(s) may deliver fluid to the expandable member at a relatively high pressure rate as required. In some examples, the electronic pump assembly includes two or more parallel pumps, 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, increasing the efficiency of the pumping operation. You can do it. In some examples, the use of parallel pumps operating out of phase with each other can cause the pumps to operate at lower frequencies, which can reduce power and improve battery life. In some examples, the electronic pump assembly can include one or more pumps in series with the pump that can increase the amount of fluid that can be delivered to the expandable 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., charge pumps).

An individual pump may include one or more manual check valves that are switched to a closed position in response to positive pressure between the expandable member and the fluid reservoir. In some examples, the active valve can be switched to a closed position to maintain (e.g., substantially maintain) pressure in the expandable member. In some examples, the active valve can be switched to an open position to relieve pressure on 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 multiple active valves. For example, one or more active valves may be in series with the pump or in parallel with the pump.

The electronic pump assembly may include a pressure sensor configured to sense pressure of the inflatable penile prosthesis. In some examples, the pressure sensor is coupled to the inflatable member. A pressure sensor can measure the pressure of the inflatable member. The controller may receive the measured pressure from the pressure sensor and automatically control the active valve(s) and/or pump(s) to regulate the pressure of the inflatable member.

For example, the electronic pump assembly can 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 inflatable member such that the pressure in the expandable member reaches a threshold. To initiate the expansion cycle, the controller may activate an active valve in the closed position and activate a pump (or multiple pumps) to move fluid into the expandable member until the pressure in the expandable member reaches a threshold. .

The controller and pressure sensor can regulate the pressure of the inflatable member (eg, during sexual activity). For example, when an inflatable member is compressed, a pressure increase (or spike) may occur. However, the pressure adjustments described herein can minimize or prevent injury to the patient or damage to the device. For example, the controller may receive a pressure reading from a pressure sensor, and in response to the measured pressure being greater than a threshold (or greater than the threshold over a period of time), the controller may cause the active valve to move to the open position. This allows a portion of the fluid to be transferred back from the expandable member toward the fluid reservoir. In response to the measured pressure corresponding to (or below) the threshold, the controller may switch the active valve to the closed position.

Additionally, there may be a small amount of leakage through the pump(s), passive valve(s), and active valve(s), which may increase with greater pressure increases during sexual activity. However, in response to the measured pressure being lower than the target threshold, the controller may activate the pump(s) to deliver additional fluid to the inflatable member such that the target pressure is achieved.

In some examples, once the inflatable member is inflated to a target pressure (e.g., during sexual activity), the controller may increase the pressure sensing rate at which the controller receives a pressure reading (e.g., the pressure may be increased during sexual activity). measured at medium-high speed intervals). If the inflatable member is not inflated to the target pressure, the controller can reduce the pressure sensing rate to save power and battery energy. This pressure regulating operation and other enhanced operations of the inflatable penile prosthesis are further described with reference to the drawings.

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 assembly 106 configured to transfer fluid between the fluid reservoir 102 and the inflatable member 104. . Inflatable member 104 may be implanted into the corpus cavernosum of the user's penis, and fluid reservoir 102 may be implanted into the user's abdominal or pelvic cavity (e.g., fluid reservoir 102 may be implanted into the user's corpus cavernosum). may be implanted in the lower part of the abdominal cavity or the upper part of the user's pelvic cavity). In some examples, at least a portion of the electronic pump assembly 106 may be implemented on the patient's body.

Expandable member 104 may be expandable upon injection of fluid into the cavity of expandable member 104. For example, upon injection of fluid into expandable member 104, expandable member 104 may increase its length and/or width as well as increase its rigidity. In some examples, expandable member 104 includes a pair of expandable cylinders or at least two cylinders, for example, a first cylinder member and a second cylinder member. The volumetric capacity of the expandable member 104 may vary depending on the size of the expandable cylinder. The fluid volume of each cylinder can vary from about 10 milliliters in smaller cylinders to about 50 milliliters in larger sizes. 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 size as the second cylindrical member.

Fluid reservoir 102 may include a vessel having an internal chamber configured to hold or receive fluid used to inflate expandable member 104 . The volumetric capacity of fluid reservoir 102 may vary depending on the size of inflatable penile prosthesis 100. The volumetric capacity of fluid reservoir 102 may be between 3 and 150 cubic centimeters. In some examples, fluid reservoir 102 is comprised of the same material as expandable member 104. In some examples, fluid reservoir 102 is comprised of a different material than expandable member 104. In some examples, fluid reservoir 102 accommodates a larger volume of fluid than expandable member 104.

In some examples, fluid reservoir 102 is (or includes) a pressure regulating flexible member 111 . The pressure regulating flexible member 111 can cause the expandable member 104 to be partially inflated without activating any of the pumps 120 . In some examples, pressure regulating flexible member 111 includes an inflatable balloon. By providing the pressure regulating flexible member 111 with a pounds per square inch (PSI) pressure level, a portion of fluid may be transferred from the fluid reservoir 102 to the expandable member. In some examples, PSI pressure levels range from 1.0 PSI to 5.0 PSI. In some examples, PSI pressure levels range from 2.0 PSI to 4.0 PSI. In some examples, the PSI pressure level is 3.0 PSI (or about 3.0 PSI). During the preparatory period (e.g., before the expansion cycle begins), pressure in the pressure regulating flexible member 111 may transfer fluid from the fluid reservoir 102 to the expandable member 104. In some examples, fluid reservoir 102 is an inflatable balloon. In some examples, the pressure regulating flexible member 111 is a structure that is separate from the fluid reservoir 102 but is disposed within a cavity of the fluid reservoir 102. In some examples, pressure regulating flexible member 111 includes an inflatable balloon disposed within a cavity of fluid reservoir 102.

The inflatable penile prosthesis 100 may include a first conduit connector 103 and a second conduit connector 105. First conduit connector 103 and second conduit connector 105 can each define a lumen configured to convey fluid to and from the electromagnetic pump assembly 106 . The first conduit connector 103 is connected to the electronic pump assembly 106 and the fluid reservoir 102 such that fluid can be transferred between the electronic pump assembly 106 and the fluid reservoir 102 through the first conduit connector 103. can be combined For example, first conduit connector 103 may define a first lumen configured to transfer fluid between electronic pump assembly 106 and fluid reservoir 102. The first conduit connector 103 may include a single or multiple tubing members for transferring fluid between the electronic pump assembly 106 and the fluid reservoir 102.

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

The electronic pump assembly 106 can automatically transfer fluid between the fluid reservoir 102 and the expandable member 104 without a user manually operating the pump (e.g., squeezing and releasing a pump bulb). The electronic pump assembly 106 includes one or more pumps 120, one or more active valves 118, a controller 114 configured to control the pump(s) 120 and the active valves 118, and one or more pressure sensors ( 130). For example, controller 114 may control pump(s) 120 to pump fluid between fluid reservoir 102 and expandable member 104. Controller 114 can control active valve 118 to switch between open and closed positions. Pump(s) 120 are configured to deliver fluid (on demand) to the expandable member 104 at relatively high pressure (e.g., up to about 20.0 PSI).

The electronic pump assembly 106 includes a battery 116 configured to provide 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, battery 116 is a rechargeable battery. In some examples, electronic pump assembly 106 (or a portion thereof) (or controller 114) is configured to connect to an external charger to charge battery 116. In some examples, electronic pump assembly 106 defines a charging interface configured to connect to (or be placed proximate to) an external charger. In some examples, the charging interface includes a universal serial bus (USB) interface configured to receive a USB charger. In some examples the charging technology is electromagnetic or piezoelectric.

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

A user can control the inflatable penile prosthesis 100 using an external device 101. A user can inflate or deflate the inflatable member 104 using an external device 101. For example, in response to a user activating an inflation cycle using external device 101 (e.g., selecting user control for external device 101), external device 101 may activate an electronic pump assembly ( A wireless signal 109 may be transmitted to 106 to initiate the inflation cycle (received via antenna 112), and the controller 114 may operate the active valve(s) 118 and pump(s) 120. can be controlled to inflate the expandable member 104 to a target inflation pressure, where the target inflation pressure is the maximum pressure threshold 160-1 (defined by the physician) or the maximum pressure threshold 160-2 ( defined by the patient). Controller 114 may place the active valve in a closed position and activate pump(s) to move fluid from fluid reservoir 102 to expandable member 104. Controller 114 may drive pump(s) 120 according to pump frequency. In some examples, the pumping architecture is designed such that audio frequencies are minimized or avoided. The frequency range that humans can perceive is 50 Hz to 19 khz. The controller 114 can drive the pump 120 according to a pump frequency of 50 Hz or less. In some examples, controller 114 drives pump 120 according to a pump frequency of 40 hz or less. In some examples, controller 114 drives pump 120 according to a pump frequency of 30 hz or less.

Maximum pressure threshold 160-1 may be defined by a physician and is the maximum allowable inflation pressure of inflatable member 104. In some examples, maximum pressure threshold 160-1 is programmed into controller 114 (and may be adjusted using external device 101 to update values stored in controller 114). The maximum pressure threshold (160-2) may be defined by the patient and is less than (or within) the maximum pressure threshold (160-1). For example, if the maximum pressure threshold 160-1 is 20.0 PSI, the maximum pressure threshold 160-2 may be 20.0 PSI or less (20.0 PSI or less). In some examples, maximum pressure threshold 160-2 is programmed into controller 114 (and may be adjusted using external device 101 to update values stored in controller 114).

In response to a user activating a contraction cycle using external device 101 (e.g., selecting user control for external device 101), external device 101 wirelessly transmits to electronic pump assembly 106. A signal 109 may be transmitted to initiate a contraction cycle (received via antenna 112), and controller 114 may activate active valve(s) 118 (and, in some examples, pump(s) ( 120-3)) can be controlled to transfer fluid from the expandable member 104 to the 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, controller 114 may control one or more pumps 120 to further move fluid from expandable member 104 to fluid reservoir 102 during a deflation cycle. In some examples, during a deflation cycle, the pressure of the expandable member 104 is greater than or equal to the partial inflation threshold 162-1 (defined by the physician) or the partial inflation threshold 162-2 (defined by the patient). The fluid is passed backwards until it reaches . In some examples, controller 114 may automatically determine to initiate a deflation cycle, which may occur when controller 114 controls active valve(s) 118 (and, in some examples, pump(s) 120-3). ) can be controlled to deliver the fluid back toward 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. . Partial inflation threshold 162-1 may be defined by the physician and, in some instances, is the inflation pressure at the end of the deflation cycle. In some examples, partial inflation pressure ranges from 0.5 to 6.0 PSI. In some examples, inflatable penile prosthesis 100 does not include a partial inflation threshold 162-1 or 162-2, and at the end of the deflation cycle, the pressure of inflatable member 104 is about 0 PSI. . In some examples, partial inflation thresholds 162-1 and 162-2 are options selectable by the user (e.g., using external device 101). In some examples, partial inflation threshold 162-1 is programmed into controller 114 (and may be adjusted using external device 101 to update values stored in controller 114). Partial inflation threshold 162-2 may be defined by the patient and is less than (or within) partial inflation threshold 162-1. For example, if partial inflation threshold 162-1 is 5.0 PSI, partial inflation threshold 162-2 may be 5.0 PSI or less than 5.0 PSI. In some examples, partial inflation threshold 162-2 is programmed into controller 114 (and may be adjusted using external device 101 to update values stored in controller 114).

Controller 114 may adjust the pressure 172 of inflatable member 104 to a partial inflation threshold (e.g., radio signal 109) in response to receiving a control signal (e.g., wireless signal 109) received via antenna 112. For example, it can be reduced from 162-1, 162-2) (or target pressure) to a lower value. For example, a patient may have difficulty urinating when inflatable member 104 is at a partial inflation threshold (eg, 162-1, 162-2) or target pressure. In some examples, a user may use an external device 101 to transmit a wireless signal 109 to reduce the pressure 172 of the inflatable member 104 to a predetermined pressure level for urination. Controller 114 controls active valve(s) 118 and/or pump(s) 120 to deliver fluid from inflatable member 104 to increase pressure 172 to a partial inflation threshold (e.g. , 162-1, 162-2) or may be reduced from the target pressure to a predetermined pressure level. The user then uses external device 101 to transmit a wireless signal 109 to controller 114 to adjust pressure 172 to a partial inflation threshold (e.g., 162-1, 162-2) or target. You can select restoration control to restore it back to pressure.

Controller 114 may be any type of controller configured to control the operation of pump(s) 120 and active valve(s) 118. In some examples, controller 114 is a microcontroller. In some examples, controller 114 includes one or more drive devices configured to drive pump(s) 120 and active valve(s) 118. In some examples, the drive device(s) are separate components from controller 114. Controller 114 may be communicatively coupled to active valve(s) 118, pump(s) 120, and pressure sensor(s) 130. In some examples, controller 114 is coupled to active valve(s) 118, pump(s) 120, and pressure sensor(s) 130 via wired data lines. Controller 114 may include a processor 113 and a memory device 115. Processor 113 may be formed on a substrate configured to execute one or more machine-executable instructions or software, firmware, or a combination thereof. Processor 113 may be semiconductor-based—that is, the processor may include semiconductor material capable of performing digital logic. Memory device 115 may store information in a form that can be read and/or executed by processor 113. Memory device 115 may store executable instructions that, when executed by processor 113, cause processor 113 to perform certain operations described herein. Controller 114 receives data via pressure sensor(s) 130 and/or external device 101 and transmits control signals to active valve(s) 118 and/or pump(s) 120. By doing so, the active valve(s) 118 and/or pump(s) 120 can be controlled.

Memory device 115 may store control parameters that can be set or modified by a user and/or physician using external device 101. In some examples, memory device 115 is configured to determine a maximum pressure threshold 160-1, a maximum pressure threshold 160-2, a partial inflation threshold 162-1, and/or a partial inflation threshold 162-1. 2) can be saved. A user or physician may use an external device 101 to update control parameters, which may be communicated to the controller 114 via the antenna 112 and then updated in the memory device 115. In some examples, controller 114 may store usage statistics 164 in memory device 115. Usage statistics 164 may include one or more statistics regarding use of inflatable penile prosthesis 100 . For example, usage statistics 164 may include number of inflations (e.g., erections), target pressure (pressure at which inflatable member 104 is inflated), and/or battery condition of battery 116 . In some examples, controller 114 may periodically transmit usage statistics 164 to external device 101.

External device 101 may communicate with 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 includes the Internet (e.g., Wi-Fi) and/or other types of data networks, such as local area networks (LANs), wide area networks (WANs), cellular It may include networks, satellite networks, 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 placed in parallel with active valve 118. In some examples, electronic pump assembly 106 includes multiple pumps 120. For example, pump 120 may include pump 120-1 and pump 120-2. In some examples, pump 120-1 is disposed in fluid passageway 125 used to fill expandable member 104 (e.g., during an expansion cycle). In some examples, pump 120-2 is disposed in a parallel fluid passageway 127 that is used to fill expandable member 104 (e.g., during an expansion cycle). In some examples, pump 120-2 is placed in parallel with pump 120-1. The pump 120-1 may deliver fluid according to a first flow rate, and the pump 120-1 may deliver 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 pump 120-3 disposed in series with active valve 118. Pump 120-3 may transfer fluid from expandable member 104 to fluid reservoir 102 (e.g., during a deflation cycle). For example, during a deflation cycle, controller 114 may activate active valve 118 to be in an open position and activate pump 120-3 to move fluid from expandable member 104 to fluid reservoir 102. can be transmitted. In some examples, pump 120-3 may deliver 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, electronic pump assembly 106 may include one or more series pumps 120 and one or more parallel pumps 120. The electronic pump assembly 106 may include a fourth pump in parallel with the pump 120-2, a fifth pump in parallel with the fourth pump, etc. In some examples, pump 120 may include one or more pumps 120 in series with one or more other pumps 120. For example, one or more pumps 120 may be in series with pump 120-1. In some examples, one or more pumps 120 may be in series with pump 120-2. In some examples, one or more pumps 120 may be in series with pump 120-3.

Each pump 120 is an electronically controlled pump. Each pump 120 may be controlled electronically by a controller 114. For example, each pump 120 can be coupled to a controller 114 and receive a signal to drive each pump 120. Pump 120 may be unidirectional in which pump 120 can transfer fluid from fluid reservoir 102 to expandable member 104 (or from expandable member 104 to fluid reservoir 102). In some examples, pump 120 is bidirectional in that pump 120 can transfer fluid from fluid reservoir 102 to expandable member 104 and from expandable member 104 to 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 bidirectional pumps.

In some examples, pump 120 is an electromagnetic pump that uses electromagnetic forces to move fluid between fluid reservoir 102 and expandable member 104. In relation to electromagnetic pumps, a magnetic fluid is set at an angle to the direction in which the fluid moves and an electric current passes through it.

In some examples, pump 120 is a piezoelectric pump. In some examples, a piezoelectric pump may be a diaphragm micropump that uses actuation of a diaphragm to drive fluid. In some examples, the piezoelectric pump may be implemented by a substrate layer of high voltage piezoelectric elements (e.g., a single substrate layer) or may be implemented by multiple substrate layers of low voltage piezoelectric elements (e.g., a stacked substrate layer). It may include one or more piezoelectric pumps (e.g., piezoelectric elements). In some examples, pump 120 includes a plurality of micropumps (e.g., piezoelectric driven micropumps) disposed on one or more substrates (e.g., wafer(s)). In some examples, the micropump includes a silicone-based material. In some examples, the micropump includes a metal (eg, steel) based material. In some examples, pump 120 is non-mechanical (e.g., has no moving parts).

In some examples, for 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, pump 120 may include a different type of piezoelectric pump, or pump 120 may include a different type of electromagnetic pump. Pump 120-1 may be a piezoelectric pump having a first number of micro pumps, pump 120-2 may be a piezoelectric pump having a second number of micro pumps, and pump 120-3 may be a piezoelectric pump having a second number of micro pumps. It may be a piezoelectric pump having three numbers of micropumps (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 manual check valves. Manual check valve(s) may help maintain pressure in expandable member 104. In some examples, pump 120 may include a single manual check valve. In some examples, pump 120 may include multiple manual check valves, such as two manual check valves or more than two manual check valves (eg, placed in series with each other). The manual check valve(s) of each pump 120 may not be controlled directly by the controller 114 , but rather may be controlled based on the pressure between the expandable member 104 and the fluid reservoir 102 . Manual check valve(s) are positioned between an open position (where fluid is permitted to flow through the manual check valve(s)) and a closed position (where fluid is prevented from flowing through the manual check valve(s)). can be converted. In some examples, with respect to pump 120-1 and pump 120-2, while the manual check valve(s) are in the closed position in the direction of flow from expandable member 104 to fluid reservoir 102; The manual check valve(s) are forward biased to allow passive flow through the manual check valve(s) in the direction from the fluid reservoir 102 to the expandable member 104. In some examples, the manual check valve(s) are transitioned to the closed position in response to positive pressure between the expandable member 104 and the fluid reservoir 102. In some examples, the manual check valve(s) are switched to the open position in response to 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) delivers to expandable member 104. The amount of fluid that can be increased can be increased. In some examples, pumps 120 may operate out of phase with each other to increase the efficiency of electronic pump assembly 106. Two parallel pumps (e.g., pump 120-1, pump 120-2) operating out of phase with each other (e.g., 180 degrees out of phase) produce an output pressure of pump 120-1. By improving the valve closure of the pump 120-2, the overall performance can be improved (and vice versa). The use of parallel pumps 120 operating out of phase with each other may cause the pumps 120 to operate at lower frequencies, which may reduce power (thereby extending battery life). Moreover, smoother flow rates can also be achieved resulting in less vibration and improved patient experience. As indicated above, one or more pumps 120 may be in series with one or more parallel pumps 120. 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. Series pump operation may make it possible to double the pressure when two similarly performing pumps 120 are used. In some examples, two or more series batch pumps 120 may operate in the same phase.

Different phases may mean two or more control signals whose phase relationship is such that one control signal is at a positive peak while the other control signal is at (or near) a negative peak. Pump 120-1 may operate in accordance with a first control signal (generated by controller 114), and pump 120-2 may operate in accordance with a second control signal (generated by controller 114). It can work accordingly. The first and second control signals may respectively control the pump 120-1 and the pump 120-2 to operate in different phases. Each of the first control signal and the second control signal may define a series of activation states, for example, a first state and a second state. For example, each of the first control signal and the second control signal may include a waveform having a series of first states (either a high state or a low state) and a second state (either a low state or a high state). . 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 of the first direction). The first signal represents a first state during a first period of time, then represents a second state during a second period of time, represents a first state during a third period of time, then represents a second state during a fourth period of time, and so on. You can. The second signal may represent a second state during a first time period, then represent a first state during a second time period, represent a second state during a third time period, represent a first state during a fourth time period, etc. there is.

Active valve 118 may be an electronically controlled valve. Active valve 118 may be controlled electronically by controller 114. For example, active valve 118 may be coupled to controller 114 and between an open position, in which fluid flows through active valve 118, and a closed position, in which fluid is prevented from flowing through active valve 118. A signal for switching the active valve 118 may be received. In some examples, active valve 118 includes a diaphragm and a ring member (eg, O-ring). In some examples, in the closed position, the flow path is obstructed by an interface between the diaphragm and the ring member. In some examples, in the open position, the diaphragm is associated with (e.g., spaced apart from) a ring member that allows fluid to flow through active valve 118. Active valve 118 may be bidirectional. Each active valve 118 may be actuated with a piezoelectric or electromagnetic diaphragm. In some examples, active valve 118 is disposed in fluid passageway 124 used to empty expandable member 104 (e.g., in a deflation cycle). In some examples, active valve 118 can be switched to a closed position to maintain (e.g., substantially maintain) pressure in expandable member 104. In some examples, active valve 118 opens to convey fluid back toward fluid reservoir 102, relieve pressure in expandable member 104, and/or allow backflow into expandable member 104. Can be converted to location. In some examples, active valve 118 may be used to maintain (e.g., substantially maintain) partial inflation pressure.

In some examples, electronic pump assembly 106 includes a single active valve 118. In some examples, electronic pump assembly 106 includes multiple 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, additional active valves 118 (e.g., series active valves 118) may be disposed in the portion of the fluid path connected to fluid reservoir 102. In some examples, additional active valves 118 (e.g., series active valves 118) may be disposed in the portion of the fluid path connected to expandable member 104. These additional active valves 118 can reduce leakage when at full inflation pressure or partial inflation 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, electronic pump assembly 106 includes a single pressure sensor 130. In some examples, electronic pump assembly 106 may include multiple pressure sensors 130.

Pressure sensor 130 is configured to measure pressure 172 of inflatable member 104. Controller 114 may include a pressure controller 174 that receives pressure readings from pressure sensor 130 according to pressure sensing rate 176 . Each pressure reading may represent the pressure 172 of the inflatable member 104 at the time of the pressure reading.

Controller 114 (e.g., pressure controller 174) and pressure sensor 130 may regulate the pressure 172 of inflatable member 104. For example, if the expandable member 104 is compressed, a pressure increase (or spike) may occur. However, the pressure controls described herein can minimize or prevent injury to the patient or damage to the inflatable penile prosthesis 100. Pressure controller 174 may control the pressure 172 of inflatable member 104 based on a combination of pump(s) 120 and active valve(s) 118 .

For example, pressure controller 174 may receive a pressure reading from pressure sensor 130 and, in response to measured pressure 172 being greater than a threshold, pressure controller 174 may activate active valve 118 ) can be activated to the open position to transfer a portion of the fluid back from the expandable member 104 toward the fluid reservoir 102. In some examples, the threshold is the maximum pressure threshold (160-1). In some examples, the threshold is the maximum pressure threshold 160-2. In some examples, the threshold is a pressure value greater than the maximum pressure threshold 160-1 and/or the maximum pressure threshold 160-2. In some examples, pressure controller 174 may cause active valve 118 to be in an open position in response to pressure 172 being greater than a threshold for a certain 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 detecting that pressure 172 corresponds to (or is below) a threshold, pressure controller 174 may switch active valve 118 to be in a closed position.

In some instances, there may be a small amount of leakage through the pump(s) 120, passive valve(s), and active valve(s) 118, which increases with greater pressure increases during sexual activity. can do. However, in response to the measured pressure 172 being less than the target pressure, the pressure controller 174 activates one or more pumps 120 to deliver additional fluid to the inflatable member 104 such that the target pressure is achieved. You can. In some examples, the target pressure is a pressure set by the patient.

In some examples, when inflatable member 104 is inflated to a target pressure (e.g., during sexual activity), controller 114 increases the pressure sensing rate 176 at which controller 114 receives pressure readings. (e.g., pressure 172 is measured at rapid intervals during sexual activity). For example, controller 114 may include pressure sensitive speed controller 180 configured to control (e.g., regulate) pressure sensitive speed 176 . In some examples, the pressure sensitive rate controller 180 may determine when the inflation cycle is activated, when the pressure 172 of the inflatable member 104 is at or near the target pressure, and/or at an activity level indicative of sexual activity ( 186) and/or set the pressure sensing rate 176 to a first value (e.g., a higher pressure sensing rate 176) in response to detection of the activity type 190. Activity level 186 and/or activity type 190 may be determined based on information obtained via accelerometer 154, described later in this disclosure. In some examples, the pressure sensitive rate controller 180 determines that when the deflation cycle is activated, the pressure 172 of the expandable member 104 is relatively low (e.g., at a partial inflation threshold 162-1 or 162- 2) or at 0 PSI, the pressure sensing speed 176 may be adjusted to a second value (e.g., a lower pressure sensing speed 176). For example, if the expandable member 104 is not inflated (or is not inflated to the target pressure), the pressure sensing speed controller 180 may reduce the pressure sensing speed 176 to save power and battery energy. You can.

In some examples, electronic pump assembly 106 may include additional pressure sensors 130 that may be located at various locations on electronic pump assembly 106. For example, pressure sensor 130 may be placed between active valves 118. In some examples, pressure sensor 130 may be placed between two pumps 120 connected in series. In some examples, pressure sensor 130 may be placed between two pumps 120 connected in parallel. In some examples, pressure sensor 130 may be disposed between active valve 118 and pump 120. In some examples, pressure sensor 130 may be coupled to fluid reservoir 102 to measure the pressure of fluid reservoir 102. Pressure sensor(s) 130 are communicatively coupled to controller 114 such that controller 114 can receive signals from pressure sensor 130 . In some examples, pressure sensor 130 is configured to sense the amount of fluid delivered to inflatable member 104 and transmit one or more signals to controller 114 indicative of the amount of fluid delivered.

The electronic pump assembly 106 may include an accelerometer 154 configured to measure 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 capable of measuring 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 (each accelerometer reading indicating the magnitude of acceleration 182 in more than one direction). and direction), activity level detector 184 may determine activity level 186. In some examples, high values (over a period of time) of activity level 186 may indicate that the user is exercising. In some examples, low values (over a period of time) of activity level 186 may indicate that the user is resting or sleeping.

In some examples, controller 114 includes activity type detector 184 configured to determine activity type 190 based on activity level 186 from activity level detector 184. In some examples, activity type 190 may be a classification of what activity the user is currently engaged in, such as exercising, resting, sleeping, moving, etc. 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, activity level detector 184 and/or activity type detector 188 may detect the inflatable penis based on the measured acceleration 182 (and in some examples in combination with one or more other signals, such as time of day). It is configured to identify the sleep pattern of the implant user. While the user is sleeping, the controller 114 may cause the inflatable member 104 to inflate (e.g., partially inflate or to a target pressure).

For example, controller 114 may include a inflation controller 194 configured to control nocturnal and/or random erections. Night-time penile swelling is a phenomenon in which the penis spontaneously becomes erect during sleep or waking up, which can be helpful for penile health. Nocturnal erections may be implemented by the inflation controller 194 to provide a more realistic experience for the patient. In some examples, inflation controller 194 may cause inflatable member 104 to inflate at set (or random) time(s) during a period of time during the night (e.g., from 3 AM to 6 AM). there is. In some examples, inflation controller 194 may cause inflatable member 104 to reach a random pressure threshold that can be stored in inflation controller 194 (and changed by the user using external device 101). It can be made to expand. In some examples, inflation controller 194 may receive activity type 190 from activity type detector 188 to confirm that the user is sleeping, and inflation controller 194 may detect pump(s) 120 and Active valve(s) 118 may be controlled to inflate the expandable member 104. In some examples, inflation controller 194 may pump at a lower frequency and/or lower pumping rate (e.g., a lower frequency and/or pumping speed than the rate used during a patient-initiated inflation cycle) to avoid waking the patient. The pump(s) 120 (e.g., pump 120-1 and pump 120-2) can be controlled to operate.

In some examples, inflation controller 194 may cause inflatable member 104 to inflate (e.g., have random erections) at random times during the day. In some examples, inflation controller 194 may determine activity type 190 (or activity level 186 from activity level detector 184) from activity type detector 188 to ensure that the user is not engaging in an activity, such as exercising. )), then proceed to activate the pump(s) 120 (e.g., pump 120, pump 120-2) to inflate the expandable member 104. In some examples, inflation controller 194 may inflate inflatable member 104 to a random pressure threshold. In some examples, the timing of nighttime and/or random erections may be controlled by the patient, for example, the patient may select an appropriate time at which nighttime and/or random erections occur.

In some examples, controller 114 may include a test period controller 192 configured to control the inflation and deflation cycle of inflatable penile prosthesis 100 after implantation into the patient's body. For example, after the inflatable penile prosthesis 100 is implemented in the body, a healing period is required. After a healing period, the patient may be instructed to begin cycling the device through inflation and deflation. However, according to embodiments described herein, test period controller 192 can implement a smart process that automatically implements inflation/deflation cycles in controlled increments. For example, test period controller 192 may repeatedly initiate expansion and deflation cycles during the test period (e.g., over day(s), week(s), month(s)). In some examples, the test period includes a series of sub-periods (e.g., four one-week periods) during which inflation and deflation settings are adjusted. For example, in each subsequent sub-period, the pressure 172 of the expandable member 104 is adjusted (e.g., increased).

For example, in a first sub-period, test period controller 192 may inflate inflatable member 104 to a first pressure, maintain inflatable member 104 at the first pressure, and then inflate member 104 to a first pressure. 104) can be contracted. In some examples, when activated, test period controller 192 controls the timing of inflation and deflation and when to deflate. In some examples, test period controller 192 may set the target pressure to the first pressure, and the user can control the inflation, deflation, and timing, but the maximum pressure is the first pressure. In a second sub-period (e.g., the following week), test period controller 192 inflates inflatable member 104 to the second pressure, maintains inflatable member 104 at the second pressure, and then: The expandable member 104 can be retracted. In some examples, the second pressure is higher than the first pressure. In some examples, when activated, test period controller 192 controls the timing of inflation and deflation and when to deflate. In some examples, test period controller 192 may set the target pressure to the second pressure, and the user may control the inflation, deflation, and timing, but the maximum pressure is the second pressure. In a third sub-period, test period controller 192 inflates inflatable member 104 to the third pressure, maintains inflatable member 104 at the third pressure, and then deflates inflatable member 104. You can do it. In some examples, the third pressure is higher than the second pressure. In some examples, when activated, test period controller 192 controls the timing of inflation and deflation and when to deflate. In some examples, test period controller 192 may set the target pressure to a third pressure, and the user can control inflation, deflation, and timing, but the maximum pressure is the second pressure.

During each sub-period, test period controller 192 may execute multiple iterations. Additionally, the test period controller 192 can control the timing of when to start each repetition. For example, after a first iteration, test period controller 192 may wait a first time period before initiating a second iteration, and then wait a second time period before initiating a third iteration; , etc. The time between repetitions may be the same or different (e.g., the time between repetitions may decrease as the number of repetitions increases, or the time between repetitions may increase as the number of repetitions increases). . Additionally, at each repetition, the test duration controller 192 may control the amount of time the expandable member 104 is held at each pressure (e.g., cycles of expansion and deflation as the number of repetitions increases). Decrease the time between cycles or increase the time between inflation and deflation cycles as the number of repetitions increases)

The electronic pump assembly 106 may include a temperature sensor 152 configured to measure the temperature 191 of the fluid within 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. Temperature sensor 152 may be connected to a portion of the fluid passageway of electronic pump assembly 106. In response to the measured temperature 191 being greater than the threshold, the controller 114 may transmit a notification message 198 to one or more external devices 101 over the network, via the antenna 112 . For example, the controller 114 may include a notification generator 196 configured to generate a notification message 198 to be transmitted to one or more external devices 101 . Notification message 198 may indicate warnings about the patient's health, use of inflatable penile prosthesis 100, and/or high levels of temperature 191. The notification generator 196 may generate a notification message 198 when the measured temperature 191 is greater than a threshold. Notification message 198 may be sent to the patient's device and/or a device associated with the physician. The temperature 191 having a value exceeding the threshold level may be an indicator of infection around the implanted device or the possibility of malfunction of the device.

Controller 114 may detect performance issues associated with inflatable penile prosthesis 100 based on pressure readings from pressure sensor 130 . For example, a leak (e.g., a leak event) may be detected based on pressure readings from pressure sensor 130. Additionally, pump and active valve performance can be inferred from pressure readings from pressure sensor 130. For example, pressure readings may indicate that pump(s) 120 and/or active valve(s) 118 are not operating properly. In some examples, controller 114 may detect a performance issue when the pump takes longer than a time threshold to reach a certain pressure. For example, controller 114 may use pressure readings from pressure sensor 130 along with a time scale to detect performance problems for one or more pumps. In response to detection of a performance problem based on the pressure readings, notification generator 196 may transmit, via a network, notification message 198 to one or more external devices 101, wherein notification message 198 is This may indicate that the implant 100 has one or more performance issues.

Electronic pump assembly 106 may include one or more devices configured to monitor the performance of a battery 116, controller 114, accelerometer 154, heart rate monitor 156, and/or other electronic devices on electronic pump assembly 106. May include a sensor 158. Based on data received via one or more sensors 158, controller 114 may determine the battery 116, controller 114, accelerometer 154, heart rate monitor 156, and/or other electronic devices. It may be determined whether one or more performance metrics 193 are not achieving a target threshold. If the performance metric 193 does not achieve a target threshold, the notification generator 196 may generate a notification message 198 and transmit, via the network, to one or more external devices 101, where the notification message ( 198) may indicate a performance problem with one of the electronics of 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, controller 114 is configured to record heart rate data 166 and store heart rate data in memory device 115 . In some examples, heart rate data 166 may include information about 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 pressure readings with the user's heart rate. In some examples, heart rate data 166 may relate pressure fluctuations (received from pressure sensor 130) to heart rate. In some examples, heart rate data 166 may relate acceleration 182 from acceleration readings from accelerometer 154 to heart rate. Controller 114 may periodically transmit heart rate data 166 to one or more external devices 101 .

Controller 114 may partially inflate inflatable member 104 such that pressure 172 of inflatable member 104 does not exceed a threshold (e.g., 0 PSI). For example, controller 114 may use pump(s) 120 and an active valve to inflate inflatable member 104 such that inflatable member 104 does not exceed a threshold (e.g., 0 PSI). It may include a partial inflation controller 195 that controls (s). Expandable member 104 may be empty or full, but both may be at 0 PSI. In some examples, partial inflation controller 195 drives active valve 118 to a closed position and causes pump(s) 120 to operate to fill expandable member 104 with fluid but still maintain pressure 172. It can be maintained at 0 PSI (or substantially about 0 PSI (e.g., 1 or 2 PSI)). The inflatable penile prosthesis 100 can maintain pressure in an equilibrium state through partial expansion under static conditions, and does not cause leakage because there is no pressure difference.

In some examples, charge pump 120 (e.g., pump 120-1, pump 120-2) is forward biased. In the case of a positive pressure difference between the fluid reservoir 102 and the expandable member 104, some fluid (e.g., leaking fluid) may move through the passive valve(s) of each pump 120. This can occur, for example, during certain gym exercises and other exercises where abdominal pressure may be applied to the fluid reservoir. Forward pressure through a forward biased pump can cause pressure to build up in the inflatable member 104, causing unintentional partial inflation in the patient.

Controller 114 may include a pressure relief controller 168 configured to regulate activation of an evacuation pump (e.g., pump 120-3) and/or opening of active valve 118 with pressure pulsations 170. You can. Pulsation 170 may be measured by pressure sensor 130. Pulsation 170 may be a brief increase in pressure 172. Immediately following pulsation 170 , pressure release controller 168 may time the opening of active valve 118 to release pressure 172 from expandable member 104 . This leads to closure of the active valve 118 before the next pulse 170. For example, pressure relief controller 168 may obtain pressure readings from pressure sensor 130 over time depending on pressure sensor rate 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. Pressure relief controller 168 may cause active valve 118 to remain in the open position (and, in some examples, activate pump 120-3) after a first time. In some examples, pressure relief controller 168 drives pump 120-3 at a lower frequency than the frequency used to drive pump 120-3 during a normal contraction cycle. Pressure relief controller 168 may cause active valve 118 to be in the closed position (and in some examples, deactivate pump 120-3) before the second time.

Pressure relief controller 168 may evacuate fluid from inflatable member 104 after a period of high activity by placing active valve 118 in an open position and, in some instances, actuating pump 120-3. For example, as discussed above, forward pressure through a forward biased pump may cause pressure to build up in the inflatable member 104, causing unintentional partial inflation in the patient. However, pressure release controller 168 may receive pressure readings from pressure sensor 130 and activity level 186 and/or activity type 190. For example, during a first time period, activity level 186 may be relatively high, indicative of activity type 164-1 of exercise. During the second time period, the activity level 186 may be relatively low, indicative of a resting activity type 164-2. In some examples, at the end of the first time period (or at the beginning of the second time period), pressure relief controller 168 may open active valve 118 and drive pump 120-3. In some examples, pressure relief controller 168 may drive pump 120-3 at a lower frequency than that used during the deflation cycle.

Electron pump assembly 106 may include a sealed enclosure 108 surrounding the components of electromagnetic pump assembly 106. Hermetic enclosure 108 may be an airtight (or substantially airtight) container. Hermetic enclosure 108 may include one or more metal-based materials. In some examples, sealed enclosure 108 is a titanium container. In some instances, the only material in contact with the patient is titanium. In some examples, sealed enclosure 108 includes a feedthrough 140 (e.g., sealed feedthrough, electrical feedthrough, feedthrough connector, etc.) for receiving/transmitting wireless signals to/from external device 101. define. In some examples, feedthrough 140 includes metal-based materials and insulator-based materials (eg, ceramics).

The electronic pump assembly 106 may include a sealed fluid chamber 110 disposed within a sealed enclosure 108. Sealed fluid chamber 110 may be a separate airtight (or substantially airtight) container within airtight enclosure 108. Sealed fluid chamber 110 may include one or more metal-based materials. In some examples, sealed fluid chamber 110 is a titanium vessel. In some examples, sealed fluid chamber 110 includes one or more non-metallic based materials (eg, 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). Enclosed fluid chamber 110 may isolate fluid from electronic devices (e.g., controller 114, accelerometer 154, heart rate monitor 156, one or more sensors 158, battery 116, etc.). You can. In other words, the electronics section may be isolated (e.g., completely isolated) from the fluid via the sealed fluid chamber 110. Enclosed fluid chamber 110 may be fluidly connected to fluid reservoir 102 and expandable member 104 . Sealed fluid chamber 110 may include active valve(s) 118, pump(s) 120, pressure sensor(s) 130, and temperature sensor 152. In some examples, sealed fluid chamber 110 may have a feedthrough 138 (e.g., sealed feedthrough, electrical feedthrough, feedthrough) to controller 114 for receiving/transmitting signals to/from controller 114. through connector, etc.). In some examples, sealed fluid chamber 110 disposed within sealed enclosure 108 creates a double sealed system. In some examples, 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 placed in series with one of the pumps 220 according to one aspect. Figure 2C illustrates a check valve 221 placed in series with one of the pumps 220 according to another aspect. Electron pump assembly 206 may be an example of electromagnetic pump assembly 106 of FIGS. 1A and 1B and may include any of the details described with reference to these figures.

Electronic pump assembly 206 includes an active valve 218, pump 220-1, pump 220-2, and 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 expandable 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 expandable member 204. Active valve 218 may include an inlet and an outlet. The inlet of the active valve 218 may be fluidly connected to the expandable member 204 and the outlet of the active valve 218 may be fluidly connected to the fluid reservoir 202.

Pump 220-1 and pump 220-2 are electronically controlled pumps. Pump 220-1 and pump 220-2 may be controlled electronically by a controller (e.g., controller 114 in FIGS. 1A and 1B). In some examples, pump 220-1 and pump 220-2 are capable of delivering fluid from fluid reservoir 202 to expandable member 204. It's one-way. However, in some examples, pump 220-1 and pump 220-2 are bidirectional. In some examples, pump 220-1 or pump 220-2 is an electromagnetic pump or a piezoelectric pump.

Pump 220-1 or pump 220-2 may include a manual check valve 223 and a manual check valve 225. Manual check valve 223 and manual check valve 225 may help maintain pressure in expandable member 204. Pump 220-1 may be placed in parallel with active valve 218. Pump 220-2 may be arranged in parallel with pump 220-1. In some examples, the use of two parallel pumps (e.g., pump 220-1, pump 220-2) can increase the amount of fluid that can be delivered to expandable member 204. In some examples, pump 220-1 and pump 220-1 may operate out of phase with each other 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 with each other (e.g., 180 degrees out of phase) operate as pump 220-1. ) By allowing the output pressure to improve valve closure of the pump 220-2, overall performance can be improved (and vice versa). In some examples, the use of parallel pumps (e.g., pump 220-1, pump 220-2) operating out of phase with each other allows pump 220-1 and pump 220-2 to have lower frequency, which can reduce power (thereby extending battery life). Moreover, smoother flow rates can also be achieved resulting in less vibration and improved patient experience.

Active valve 218 may be an electronically controlled valve. Active valve 218 may be controlled electronically by a controller (e.g., controller 114 in FIGS. 1A and 1B). For example, active valve 218 may be configured to switch active valve 218 between an open position, in which fluid flows through active valve 218, and a closed position, in which fluid is prevented from flowing through active valve 218. signals can be received. In some examples, active valve 218 can be switched to a closed position to maintain (e.g., substantially maintain) pressure in expandable member 204. In some examples, active valve 218 opens to convey fluid back toward fluid reservoir 202, relieve pressure in expandable member 204, and/or allow backflow into expandable member 204. Can be converted to location. In some examples, active valve 218 may be used to maintain (e.g., substantially maintain) partial inflation pressure.

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

In some examples, as shown in FIG. 2C, electronic pump assembly 206 may include a check valve 221 disposed in series with pump 220 (pump 220 is connected to pump 220-1). or pump (220-2) or both). In some examples, as shown in FIG. 2B, check valve 221 is disposed between pump 220 and expandable member 204. In some examples, as shown in FIG. 2C, check valve 221 is disposed between pump 220 and fluid reservoir 202. Check valve 221 may define cracking pressure 227. When the pressure difference between the inlet of the check valve 221 and the outlet of the check valve 221 is greater than the cracking pressure 227, the check valve 221 is configured to open and allow fluid to pass. When the pressure difference between the inlet of the check valve 221 and the outlet of the check valve 221 is less than the cracking pressure 227, the check valve 221 is closed and configured to block the transfer of fluid. In some examples, cracking pressure 227 ranges from 1.0 PSI to 5.0 PSI. In some examples, cracking pressure 227 ranges from 2.0 PSI to 4.0 PSI. In some examples, cracking pressure 227 is 3.0 PSI. A check valve 221 disposed in series with the pump 220 can reduce leakage or inadvertent flow from the fluid reservoir 202 to the expandable member 204 during activities that exert abdominal pressure on the fluid reservoir 202. there is. In some examples, check valve 221 is closed during normal non-erectile periods to ensure that unintentional partial erections are minimized.

3 illustrates an electronic pump assembly 306 according to one aspect. The electron pump assembly 306 may be an example of the electron pump assembly 106 of FIGS. 1A and 1B and/or the electron pump assembly 206 of FIGS. 2A-2C and may include any of the details described with reference to these figures. may include Electronic pump assembly 306 is identical to electronic pump assembly 206 of FIGS. 2A-2C except that an evacuation pump (e.g., pump 320-3) is included in electronic pump assembly 306. (similar) can be done.

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

Pump 320-1, pump 320-2, and pump 320-3 are electronically controlled pumps. Pump 320-1, pump 320-2, and pump 320-3 may be controlled electronically by a controller (e.g., controller 114 in FIGS. 1A and 1B). In some examples, pump 320-1 and pump 320-2 are capable of delivering fluid from fluid reservoir 302 to expandable member 304. It's one-way. In some examples, pump 320-3 is unidirectional in that pump 320-3 can transfer fluid from expandable member 304 to fluid reservoir 302. However, in some examples, pump 320-1, pump 320-2, and pump 320-3 are bidirectional. In some examples, pump 320-1, pump 320-2, and pump 320-3 may be electromagnetic pumps or piezoelectric pumps.

Pump 320-1, pump 320-2, or pump 320-3 may include a manual check valve 323 and a manual check valve 325. Manual check valve 323 and manual check valve 325 may help maintain pressure in expandable member 304. Pump 320-1 may be placed in parallel with active valve 318. Pump 320-2 may be arranged in parallel with pump 320-1. Pump 320-3 may be placed in series with active valve 318. Pump 320-3 may be arranged in parallel with pump 320-1 or pump 320-2.

4 illustrates an example of a portion of an electronic pump assembly 406 according to one aspect. The electron pump assembly 406 may be an example of the electron pump assembly 106 of FIGS. 1A and 1B, the electron pump assembly 206 of FIGS. 2A-2C, and/or the electron pump assembly 306 of FIGS. 3 and Any of the details described with reference to the drawings may be included.

The electronic pump assembly 406 is configured to transfer fluid between the fluid reservoir 402 and the expandable member 404. Electronic pump assembly 406 can automatically transfer fluid between fluid reservoir 402 and expandable member 404 without a user manually operating the pump (e.g., squeezing and releasing a pump bulb).

The electronic pump assembly 406 includes a pump 420-1 disposed within a fluid passageway 424 (e.g., a fill passageway), and an active valve disposed within a fluid passageway 427 (e.g., an empty passageway). 418). Pump 420-1 may be an electromagnetic pump or a piezoelectric pump. The pump 420-1 may include a manual check valve 423 and a manual check valve 425. Fluid passage 427 may be a separate fluid branch (and parallel) to fluid passage 424. The fluid passage 427 is a passage that transfers fluid from the fluid reservoir 402 to the expandable member 404. The fluid passage 424 is a passage that transfers fluid from the expandable member 404 to the fluid reservoir 402. Pump 420-1 is placed in parallel with active valve 418.

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

Active valve 448, pump 420-1, active valve 418, active valve 452, active valve 418, and pump 420-2 may be connected to a controller and/or actuator (e.g., It can be controlled electronically by the controller 114 of FIGS. 1A and 1B. Pump 420-1 and pump 420-2 may be unidirectional or bidirectional. With respect to fluid passageway 427, in some examples, pump 420-1 and active valve 419 may swap positions (e.g., active valve 419 may be used to connect active valve 448 and pump ( in series between 420-1). With respect to fluid passageway 424 , in some examples, active valve 418 and pump 420-2 may swap positions (e.g., pump 420-1 may switch between active valve 418 and active valve 420-2). in series with and between valves 448).

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

In some examples, electronic pump assembly 406 may include pressure sensor 430 and pressure sensor 431. Pressure sensor 430 and pressure sensor 431 are connected to a controller (e.g., controller 114 in FIGS. 1A and 1B), and the controller controls the pressure measured from pressure sensor 430 and pressure sensor 431. receives.

Pressure sensor 430 is configured to measure the pressure of inflatable member 404. The controller may receive the measured pressure from the pressure sensor 430 and automatically control the active valve and/or pump to adjust the pressure. In some examples, pressure sensor 431 is configured to measure the pressure of fluid reservoir 402. In some examples, pressure sensor 431 may detect intra-abdominal pressure (which may increase during activities such as exercise), and the controller may control active valves and pumps to minimize or prevent accidental inflation. In some examples, electronic pump assembly 406 may include one or more pressure sensors at other locations within electronic pump assembly 406. For example, a pressure sensor may be placed between active valve 448 and pump 420-1. In some examples, a pressure sensor may be placed between pump 420-1 and active valve 419. In some examples, a pressure sensor may be placed between active valve 448 and active valve 418. In some examples, a pressure sensor may be placed between active valve 418 and pump 420-2.

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

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

To implant the inflatable cylinder 510, the surgeon first prepares the patient. Surgeons often make an incision in the scrotal area, for example, where the base of the penis meets the top of the scrotum. From the scrotal incision, the surgeon can expand the patient's penile corpus cavernosum to prepare the patient to receive the inflatable cylinder 510. The corpus cavernosum is one of two parallel columns of erectile tissue that form the dorsal portion of the body of the penis, i.e. one of two slender columns that substantially extend the length of the penis. The surgeon also prepares the patient to receive the second end portion 528 by expanding two areas of the pubic region. The surgeon may measure the length of the penile corpus cavernosum from the incision and the expanded area of the pubic region to determine the appropriate size of inflatable cylinder 510 to implant.

After the patient is prepared, the inflatable penile prosthesis 500 is implanted into the patient. The tip of the first end portion 524 of each expandable cylinder 510 may be attached to a suture. The other end of the suture may be attached to a needle member (eg, a Keith needle). The needle member is inserted into the incision and expanded corpus cavernosum. Afterwards, the needle member is forced through the crown of the penis. The surgeon pulls the sutures to pull the expandable cylinder 510 into the corpus cavernosum. This is done for each expandable cylinder 510 of the pair. Once inflation chamber 522 is in place, the surgeon can remove the suture from the tip. The surgeon then inserts the second end portion 528. The surgeon inserts the posterior end of the inflatable cylinder 510 into the incision and forces the second end portion 528 toward the pubic bone (PB) until each inflatable cylinder 510 is in place.

A user can control the inflatable penile prosthesis 500 using an external device 501. In some examples, a user may use an 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 transmit a wireless signal to electronic pump assembly 506 to dislodge the inflatable cylinder from fluid reservoir 550. An expansion cycle delivering fluid to 510 may be initiated. In some examples, in response to a user activating a deflation cycle using external device 501, external device 501 transmits a wireless signal to electronic pump assembly 506 to pump fluid from expandable cylinder 510 into a reservoir. A contraction cycle that delivers fluid to 550 may be initiated. In some examples, during the deflation cycle, fluid is delivered backwards until the pressure in the expandable cylinder 510 reaches the partial inflation pressure.

FIG. 6 illustrates a flow diagram 600 illustrating an example operation of a method of operating an electronic pump assembly of an inflatable penile prosthesis. The exemplary operations of flow diagram 600 may be performed by any of the inflatable penile prosthesis and/or electronic pump assemblies (e.g., 106, 206, 306, 406, 506) described herein.

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

Detailed embodiments are disclosed herein. However, it is understood that the disclosed embodiments are merely examples and may be embodied in various forms. Accordingly, the specific structural and functional details disclosed herein should not be construed as limiting, but merely as a basis for the claims and in fact as a teaching to those skilled in the art to vary the embodiments in any suitably detailed structure. It should be interpreted as a representative basis for doing so. Additionally, the terms and phrases used herein are not intended to be limiting but to provide an understandable explanation of the disclosure.

As used herein, the singular terms are defined as one or more than one. As used herein, the term “other” is defined as at least second or higher. As used herein, the terms “comprising” and/or “having” are defined as comprising (i.e., open connection). As used herein, the terms “coupled” or “removably coupled” are defined as connected, but not necessarily directly and mechanically.

Generally, embodiments relate to body implants. The terms patient or user may hereinafter be used to refer to a person who benefits from a medical device or method disclosed in this disclosure. For example, a patient can be a person who has a medical device implanted in their body or a method disclosed by the present disclosure to operate the medical device. For example, in some embodiments, the patient may be a human.

Although certain features of the described implementations have been illustrated as described herein, many modifications, substitutions, changes and equivalents will now occur to those skilled in the art. Accordingly, it is 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 (35)

It is an inflatable penile prosthesis,
a fluid reservoir configured to retain fluid;
inflatable member; and
an electronic pump assembly configured to transfer fluid between the fluid reservoir and the expandable member, the electronic pump assembly comprising:
Pump;
active valve;
a pressure sensor configured to measure pressure of the inflatable member; and
An inflatable penile prosthesis, comprising a controller configured to control at least one of the pump or the active valve based on measured pressure. 2. The method of claim 1, wherein the controller is configured to cause the active valve to be in an open position to transfer a portion of fluid from the inflatable member to the fluid reservoir in response to the measured pressure being greater than a threshold. type penile prosthesis. 3. The method of claim 1 or 2, wherein the controller is configured to cause a pump to operate to transfer a portion of fluid from the fluid reservoir to the inflatable member in response to the measured pressure being less than a threshold. type penile prosthesis. 4. The inflatable penile prosthesis of any one of the preceding claims, wherein the fluid reservoir includes a pressure regulating flexible member configured to allow the inflatable member to be partially inflated without activating the pump. The inflatable penile prosthesis of any one of claims 1 to 4, wherein the electronic pump assembly includes an accelerometer configured to measure acceleration of a user of the inflatable penile prosthesis. 6. The method of claim 5, wherein the controller is configured to identify a sleep pattern 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 expand when the user is sleeping. An inflatable penile prosthesis. 7. The inflatable penile prosthesis of any one of claims 1 to 6, wherein the electronic pump assembly includes a heart rate sensor configured to monitor the heart rate of a user of the inflatable penile prosthesis. 8. The inflatable penile prosthesis of any one of claims 1 to 7, wherein the electronic pump assembly includes a temperature sensor configured to measure the temperature of the fluid. 9. The method of any one of claims 1 to 8, wherein the controller is configured to repeatedly initiate an expansion cycle and a deflation cycle during a test period defining a series of sub-periods, wherein in each subsequent sub-period, the expansion type An inflatable penile prosthesis with adjustable member pressure. 10. The method of any one of claims 1 to 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, and in response to a wireless signal , wherein the controller is configured to inflate the inflatable member to a maximum pressure threshold during an inflation cycle. 11. The method of any one of claims 1 to 10, wherein the controller comprises a memory configured to store at least one of a maximum pressure threshold or a partial pressure threshold, wherein the controller is configured to detect an external device via an antenna of the electronic pump assembly. and update the value of at least one of the maximum pressure threshold or the partial pressure threshold based on information received from. 12. The method of any one of claims 1 to 11, wherein the controller is configured to detect a performance problem associated with the inflatable penile prosthesis based on pressure readings from the pressure sensor, wherein the controller detects the performance problem. An inflatable penile prosthesis configured to transmit a notification message to one or more external devices over a network in response to being activated. 13. The method of any one of claims 1 to 12, wherein the controller is configured to obtain pressure readings from the pressure sensor over time according to the pressure sensor rate, wherein the controller is configured to generate a first pressure pulsation at a first time. and configured to detect a second pressure pulsation at a second time, wherein the controller is configured to cause the active valve to remain in the open position after the first time, and wherein the controller is configured to cause the active valve to remain in the open position before the second time. An inflatable penile prosthesis configured to be in a closed position. How to operate an inflatable penile prosthesis,
Receiving, by an antenna of the electronic pump assembly, a wireless control signal from an external device;
activating, by the controller, a pump of the electronic pump assembly to deliver fluid from the fluid reservoir to the expandable member in response to a wireless control signal such that a pressure in the expandable member reaches a threshold;
measuring the pressure of the inflatable member by a pressure sensor; and
activating, by the controller, an active valve of an electronic pump assembly to an open position to transfer a portion of fluid from the expandable member to the fluid reservoir in response to the measured pressure being greater than a threshold. method. According to clause 14,
detecting, by the controller, whether the measured pressure corresponds to a threshold value; and
activating, by the controller, the active valve to a closed position in response to detecting that the measured pressure corresponds to a threshold. It is an inflatable penile prosthesis,
a fluid reservoir configured to retain fluid;
inflatable member; and
an electronic pump assembly configured to transfer fluid between the fluid reservoir and the expandable member, the electronic pump assembly comprising:
Pump;
active valve;
a pressure sensor configured to measure pressure of the inflatable member; and
An inflatable penile prosthesis, comprising a controller configured to control at least one of the pump or the active valve based on measured pressure. 17. The method of claim 16, wherein the controller is configured to cause the active valve to be in an open position to transfer a portion of fluid from the inflatable member to the fluid reservoir in response to the measured pressure being greater than a threshold. type penile prosthesis. 17. The inflatable penile prosthesis of claim 16, wherein the controller is configured to cause a pump to actuate a portion of fluid from the fluid reservoir to the inflatable member in response to the measured pressure being less than a threshold. 17. The inflatable penile prosthesis of claim 16, wherein the fluid reservoir includes a pressure regulating flexible member configured to allow the inflatable member to be partially inflated without activating the pump. 17. The inflatable penile prosthesis of claim 16, wherein the electronic pump assembly includes an accelerometer configured to measure acceleration of a user of the inflatable penile prosthesis. 21. The method of claim 20, wherein the controller is configured to identify a sleep pattern of a user of the inflatable penile prosthesis based on measured acceleration, and the controller is configured to cause the inflatable member to at least partially expand when the user is sleeping. An inflatable penile prosthesis. 17. The inflatable penile prosthesis of claim 16, wherein the electronic pump assembly includes a heart rate sensor configured to monitor the heart rate of a user of the inflatable penile prosthesis. 17. The inflatable penile prosthesis of claim 16, wherein the electronic pump assembly includes a temperature sensor configured to measure the temperature of the fluid. 17. The method of claim 16, wherein the controller is configured to repeatedly initiate expansion and contraction cycles during a test period defining a series of sub-periods, wherein in each subsequent sub-period the pressure of the inflatable member is adjusted. type penile prosthesis. It is an inflatable penile prosthesis,
a fluid reservoir configured to retain fluid;
inflatable member; and
an electronic pump assembly configured to transfer fluid between the fluid reservoir and the expandable member, the electronic pump assembly comprising:
an antenna configured to receive a wireless signal from an external device;
Pump;
active valve;
a pressure sensor configured to measure pressure of the inflatable member; and
An inflatable penile prosthesis, comprising a controller configured to control at least one of the pump or the active valve based on at least one of measured pressure or a wireless signal. 26. The method of claim 25, wherein the electronic pump assembly includes an accelerometer configured to measure acceleration of a user of the inflatable penile prosthesis, and the controller is configured to determine an activity type based on the measured acceleration, wherein the controller is configured to determine the activity type. An inflatable penile prosthesis configured to adjust a pressure sensing speed associated with the pressure sensor based on 26. The method of 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, and in response to the wireless signal, the controller is configured to partially inflate the inflatable member during an inflation cycle. An inflatable penile prosthesis configured to inflate the member to a maximum pressure threshold. 26. The method of claim 25, wherein the electronic pump assembly includes a temperature sensor configured to measure a temperature of the fluid, and in response to the measured temperature being greater than a threshold, the controller sends a notification, via the network, via the antenna. An inflatable penile prosthesis configured to transmit a message to one or more external devices. 26. The method of claim 25, wherein the controller includes a memory configured to store at least one of a maximum pressure threshold or a partial pressure threshold, wherein the controller determines the maximum pressure threshold based on information received from an external device via an antenna. or update the value of at least one of the partial pressure thresholds. 26. The method of claim 25, wherein the controller is configured to detect a performance problem associated with the inflatable penile prosthesis based on pressure readings from the pressure sensor, and the controller notifies via the network in response to a performance problem being detected. An inflatable penile prosthesis configured to transmit a message to one or more external devices. 26. The inflatable penile prosthesis of claim 25, wherein the electronic pump assembly includes a battery configured to power a controller, and the electronic pump assembly includes a sensor configured to monitor performance of the battery. 26. The method of claim 25, wherein the controller is configured to obtain pressure readings from the pressure sensor over time according to a pressure sensor rate, wherein the controller detects a first pressure pulsation at a first time and a second pressure pulse at a second time. 2 configured to detect pressure pulsations, wherein the controller is configured to cause the active valve to be in an open position after the first time, and the controller is configured to cause the active valve to be in a closed position before the second time. Inflatable penile prosthesis. 26. The inflatable penile prosthesis of claim 25, wherein the electronic pump assembly includes a check valve in series with the pump. How to operate an inflatable penile prosthesis,
Receiving, by an antenna of the electronic pump assembly, a wireless control signal from an external device;
activating, by the controller, a pump of the electronic pump assembly to deliver fluid from the fluid reservoir to the expandable member in response to a wireless control signal such that a pressure in the expandable member reaches a threshold;
measuring the pressure of the inflatable member by a pressure sensor; and
activating, by the controller, an active valve of an electronic pump assembly to an open position to transfer a portion of fluid from the expandable member to the fluid reservoir in response to the measured pressure being greater than a threshold. method. According to clause 34,
detecting, by the controller, whether the measured pressure corresponds to a threshold value; and
activating, by the controller, the active valve to a closed position in response to detecting that the measured pressure corresponds to a threshold.

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