An electronically implantable penile prosthesis with remote actuation

Abstract

According to one aspect, an inflatable penile prosthesis includes a fluid reservoir configured to hold a 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, and a controller configured to receive an external signal to operate an inflation cycle and control at least one of the pump or the active valve to transfer fluid to the inflatable member. The controller includes a printed circuit board assembly. The printed circuit board assembly includes a microprocessor or state machine.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of and claims priority to U.S. Provisional Patent Application No. 63 / 269,439, entitled "ELECTRONIC IMPLANTABLE PENILE PROSTHESIS WITH REMOTE ACTIVATION," filed on March 16, 2022, which claims priority to U.S. Provisional Patent Application No. 18 / 183,685, entitled "ELECTRONIC IMPLANTABLE PENILE PROSTHESIS WITH REMOTE ACTIVATION," filed on March 14, 2023, the disclosures of which are incorporated herein by reference in their entireties.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 269,439, filed March 16, 2022, the disclosure of which is incorporated by reference in its entirety.

[0003] The present disclosure relates generally to bodily implants, and more particularly to bodily implants such as electronically implantable penile prostheses with remote actuation and / or power charging. [Background technology]

[0004] One treatment for male erectile dysfunction is the implantation of 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 that is implantable in the scrotum and that can be manually squeezed by a user to move fluid from a reservoir into the cylinder to cause an erection. For some patients, the manual pumping procedure can be relatively difficult. Summary of the Invention [Means for solving the problem]

[0005] According to one aspect, an inflatable penile prosthesis includes a fluid reservoir configured to hold a 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, and a controller configured to receive an external signal to operate an inflation cycle and control at least one of the pump or the active valve to transfer fluid to the inflatable member. The controller includes a printed circuit board assembly. The printed circuit board assembly includes a microprocessor or state machine.

[0006] According to some embodiments, the inflatable penile prosthesis may include one or more of the following features (or any combination thereof): The electronic pump assembly includes an antenna. The antenna is configured to receive an external signal. The external signal may include a Bluetooth signal. The external signal may include a Near Field Communication (NFC) signal or another radio frequency (RF) signal. The printed circuit board assembly may include a power source. The power source is configured to be charged by wireless transmission (e.g., an NFC signal, a capacitive or inductive signal, an RF signal, etc.). The printed circuit board assembly includes a magnetic sensing circuit, and the controller is configured to detect operation of the inflation cycle in response to the magnetic sensing circuit detecting the presence of a magnetic field. The electronic pump assembly includes an antenna, the antenna configured to receive an external signal, the external signal including a radio frequency (RF) signal. The electronic pump assembly includes an inductive antenna, the inductive antenna configured to receive an external signal, the external signal including an inductive signal. The external signal may include an ultrasonic signal. The electronic pump assembly includes a pressure sensor, and the controller is configured to receive pressure measurements from the pressure sensor indicative of pressure in the inflatable member and to determine that an inflation cycle has been activated in response to the pressure exceeding a threshold level. The electronic pump assembly includes a first conductive plate, and the controller is configured to determine that an inflation cycle has been activated in response to a second conductive plate of the external device being disposed within a threshold distance of the first conductive plate. The electronic pump assembly includes an acoustic sensor configured to receive an acoustic signal, and the controller is configured to determine that an inflation cycle has been activated in response to the acoustic signal.

[0007] According to one aspect, an inflatable penile prosthesis includes a fluid reservoir configured to hold fluid, an inflatable member, and an electronic pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member. The electronic pump assembly includes a pump, an active valve, an antenna configured to receive an external signal, a controller configured to determine to activate an inflation cycle based on the external signal and to control at least one of the pump or the active valve to transfer fluid to the inflatable member, and a power source configured to provide power to the controller, the power source configured to be recharged by wireless transmissions received via the antenna.

[0008] According to some embodiments, the inflatable penile prosthesis may include one or more of the following features (or any combination thereof): The wireless transmission includes Near Field Communication (NFC) transmission. The wireless transmission includes Radio Frequency (RF) transmission. The wireless transmission includes Capacitive or Inductive transmission. The controller includes a printed circuit board assembly, the printed circuit board assembly including a microprocessor configured to interpret the external signal. The printed circuit board assembly includes a state machine configured to interpret the external signal. The state machine includes a field programmable gate array or an application specific integrated circuit.

[0009] According to one aspect, a method of controlling an inflatable penile prosthesis includes a controller of an electronic pump assembly detecting an external signal, the controller including a printed circuit board assembly, the printed circuit board assembly including a microprocessor or state machine, determining to activate an inflation cycle of the inflatable penile prosthesis based on the external signal, and activating at least one of a pump or an active valve to transfer fluid from a fluid reservoir to an inflatable member. In some examples, the method includes charging a battery of the electronic pump assembly based on wireless communications received via an antenna of the electronic pump assembly. [Brief description of the drawings]

[0010] [Figure 1A] FIG. 1 illustrates an inflatable penile prosthesis having an electronic pump assembly, according to one embodiment. [Figure 1B] FIG. 2 illustrates a controller for an electronic pump assembly, according to one embodiment. [Figure 1C] FIG. 1 illustrates an example of a microcontroller for an electronic pump assembly, according to one embodiment. [Figure 1D] FIG. 1 illustrates an example of a state machine for an electronic pump assembly, according to one aspect. [Figure 1E] 1A-1D illustrate multiple states of an inflatable penile prosthesis, according to one embodiment. [Figure 1F] 1A-1C illustrate various types of power systems that may be used in an electronic pump assembly, according to one aspect. [Diagram 2] FIG. 1 illustrates an inflatable penile prosthesis having an electronic pump assembly configured to communicate with an external device using a Bluetooth wireless connection, according to one embodiment. [Diagram 3] FIG. 1 illustrates an inflatable penile prosthesis having an electronic pump assembly configured to communicate with an external device using a near field communication (NFC) connection, according to one embodiment. [Figure 4] FIG. 1 illustrates an inflatable penile prosthesis having an electronic pump assembly configured to communicate with an external device using a magnetic field, according to one embodiment. [Diagram 5] FIG. 1 illustrates an inflatable penile prosthesis having an electronic pump assembly configured to communicate with an external device using radio frequency signals, according to one embodiment. [Figure 6] FIG. 1 illustrates an inflatable penile prosthesis having an electronic pump assembly configured to communicate with an external device using a low-frequency inductive signal, according to one embodiment. [Figure 7] FIG. 1 illustrates an inflatable penile prosthesis having an electronic pump assembly configured to communicate with an external device using ultrasound signals, according to one embodiment. [Figure 8]FIG. 1 illustrates an inflatable penile prosthesis having an electronic pump assembly configured to actuate inflation or deflation cycles based on a gripping signal sensed by a pressure sensor, according to one embodiment. [Figure 9] FIG. 1 illustrates an inflatable penile prosthesis having an electronic pump assembly configured to communicate with an external device using capacitive signals, according to one embodiment. [Figure 10] FIG. 1 illustrates an inflatable penile prosthesis having an electronic pump assembly configured to communicate with an external device using acoustic signals, according to one embodiment. [Figure 11] FIG. 13 shows an inflatable penile prosthesis having an electronic pump assembly according to another embodiment. [Figure 12] 1 is a flow chart illustrating an example operation of an electronic pump assembly according to one aspect. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The present disclosure relates to an inflatable penile prosthesis that includes an electronic pump assembly that transfers fluid between a fluid reservoir and an inflatable member. The electronic pump assembly includes one or more pumps (e.g., electromagnetic or piezoelectric pumps), one or more active valves, a pressure sensor, and a controller. The controller can control the pump(s) and / or the active valve to inflate or deflate the inflatable member. In some examples, the controller can activate the pump(s) by transitioning the active valve to a closed position to pump fluid from the fluid reservoir to the inflatable member during an inflation cycle. The controller can stop the pump when the pressure sensor detects a target pressure (or a timer expires). In some examples, when a deflation cycle is activated, the controller transitions the active valve to an open position (thus allowing fluid to flow through the active valve) and the fluid returns to the fluid reservoir.

[0012] In some examples, the controller includes a microcontroller and / or a microprocessor. In some examples, the controller includes a state machine implemented by application specific integrated circuit(s) and / or field programmable gate array. In some examples, the state machine includes a number of states, such as a wait state in which the inflatable member is in a deflated state, an inflating state in which the inflatable member is inflated to a target pressure, a hold state in which the pressure is held at the target pressure, and a deflated state in which the inflatable member is deflated.

[0013] In some examples, the controller can wirelessly communicate with an external device (e.g., a computer, a smartphone, a tablet, a pendant, a key fob, etc.) to control the inflatable penile prosthesis (e.g., to inflate or deflate the inflatable member). In some examples, the external device is a near field communication (NFC) device (e.g., a smartphone or a custom-designed controller), and the controller can receive an NFC signal from the external device via an antenna on the electronic pump assembly to inflate or deflate the inflatable member. In some examples, the external device is a Bluetooth device (e.g., a smartphone or a custom-designed controller), and the controller can receive a Bluetooth signal from the external device via an antenna on the electronic pump assembly to inflate or deflate the inflatable member. In some examples, the external device is a magnet device, and the controller includes a magnet sensing circuit that operates in the presence of a magnetic field from the magnet device.

[0014] In some examples, the external device is a radio frequency (RF) device and the controller can receive a radio frequency (RF) signal (e.g., a high frequency signal) (e.g., kHz-GHz) from the external device via an antenna on the electronic pump assembly to inflate or deflate the inflatable member. In some examples, the external device is an inductive device and the controller can receive a low frequency inductive signal from the external device via an inductive antenna on the electronic pump assembly to inflate or deflate the inflatable member. In some examples, the external device is an ultrasonic device and the controller can receive an ultrasonic signal from the external device via an antenna on the electronic pump assembly to inflate or deflate the inflatable member.

[0015] In some examples, the inflation and / or deflation cycles can be controlled without the use of an external device. In some examples, the inflation cycle is enacted based on an external signal, which is a gripping action on the penis. For example, the gripping action on the penis can compress the cylinder to trigger the inflation cycle (or inflation mode). For example, a pressure sensor can detect an increase in pressure level in the inflatable member, and the controller can determine that the increase in pressure level corresponds to an inflation actuation signal. Non-actuation can be detected by a coded sequence of gripping actions, a trigger by an external device, or a timer. In some examples, the controller includes an acoustic sensor configured to detect an acoustic signal. For example, the acoustic sensor can detect a tap on the abdomen to trigger the inflation cycle. In some examples, non-actuation can be detected by a coded sequence of taps. In some examples, the external device is a capacitive device (e.g., having a first plate of a capacitor) and the controller includes a second plate of the capacitor. When the first plate is placed (e.g., implanted in a patient) in close proximity (e.g., within a threshold distance) to the second plate, the controller can receive the capacitive signal to inflate or deflate the inflatable member.

[0016] The electronic pump assembly may include a power source such as a primary battery (e.g., no energy transfer required), a rechargeable battery, energy storage (e.g., capacitor(s)), and / or direct power without the use of a storage device. In some examples, low frequency technology (e.g., inductive power) may enable operation and charge or directly power the inflatable penile prosthesis 100. The external charger may be a portable device or a static device such as a flat encapsulated coil (e.g., on a chair seat or mattress). In some examples, NFC transmission may enable operation and charge or directly power the implantable device. In some examples, VHF and UHF transmission may enable operation and charge or directly power the implantable device. In some examples, capacitive coupling technology may enable operation and charge or directly power the implantable device.

[0017] 1A-1F show an inflatable penile prosthesis 100 having an electronic pump assembly 106, according to one embodiment, which can improve the performance of the inflatable penile prosthesis 100. The inflatable penile prosthesis 100 includes a fluid reservoir 102, an inflatable member 104, and an electronic pump assembly 106 configured to transfer fluid between the fluid reservoir 102 and the inflatable member 104. The inflatable member 104 can be implanted in the corpus cavernosum of the user, and the fluid reservoir 102 can be implanted in the abdominal or pelvic cavity of the user (e.g., the fluid reservoir 102 can be implanted in a lower portion of the abdominal cavity of the user or an upper portion of the pelvic cavity of the user). In some examples, at least a portion of the electronic pump assembly 106 can be implemented inside the patient's body.

[0018] The inflatable member 104 can expand when a fluid is injected into the cavity of the inflatable member 104. For example, the inflatable member 104 can increase in length and / or width and become more rigid when a fluid is injected into the inflatable member 104. In some examples, the inflatable member 104 includes a pair of inflatable cylinders or at least two cylinders, such as a first cylinder member and a second cylinder member. The volume of the inflatable member 104 can depend on the size of the inflatable cylinders. The volume of fluid in each cylinder can vary from about 10 milliliters for a small cylinder to about 70 milliliters for a large size. In some examples, the first cylinder member can be larger than the second cylinder member. In some examples, the first cylinder member can have the same size as the second cylinder member.

[0019] The fluid reservoir 102 contains a fluid that is used to inflate the inflatable member 104. The volume of the fluid reservoir 102 can vary depending on the size of the inflatable penile prosthesis 100. The volume of the fluid reservoir 102 can be up to 150 cubic centimeters. In some examples, the fluid reservoir 102 is constructed from the same material as the inflatable member 104. In some examples, the fluid reservoir 102 is constructed from a different material than the inflatable member 104. In some examples, the fluid reservoir 102 contains a larger amount of fluid than the inflatable member 104. In some examples, the fluid reservoir 102 is (or includes) a pressure-regulating flexible member. In some examples, the pressure-regulating flexible member can partially inflate the inflatable member 104 without any activation of the pump 120. In some examples, the pressure-regulating flexible member includes an inflatable balloon.

[0020] The inflatable penile prosthesis 100 may include a first conduit connector 103 and a second conduit connector 105. The first conduit connector 103 and the second conduit connector 105 may each define a lumen configured to transfer fluid to and from the electronic pump assembly 106. The first conduit connector 103 may be coupled to the electronic pump assembly 106 and the fluid reservoir 102 such that fluid may be transferred between the electronic pump assembly 106 and the fluid reservoir 102 via the first conduit connector 103. For example, the first conduit connector 103 may define a first lumen configured to transfer fluid between the electronic pump assembly 106 and the fluid reservoir 102. The first conduit connector 103 may include a single or multiple tube members that transfer fluid between the electronic pump assembly 106 and the fluid reservoir 102.

[0021] The second conduit connector 105 can be coupled to the electronic pump assembly 106 and the inflatable member 104 such that fluid can be transferred between the electronic pump assembly 106 and the inflatable member 104 via the second conduit connector 105. For example, the second conduit connector 105 can define a second lumen configured to transfer fluid between the electronic pump assembly 106 and the inflatable member 104. The second conduit connector 105 can include a single or multiple tubing members that transfer fluid between the electronic pump assembly 106 and the inflatable member 104. In some examples, the first conduit connector 103 and the second conduit connector 105 can include a silicone rubber material. In some examples, the electronic pump assembly 106 can be directly connected to the fluid reservoir 102.

[0022] The electronic pump assembly 106 can automatically transfer fluid between the fluid reservoir 102 and the inflatable member 104 without a user manually operating the pump (e.g., squeezing and releasing a pump valve). The electronic pump assembly 106 includes one or more pumps 120, one or more active valves 118, a pressure sensor 130 configured to monitor the pressure of the inflatable member 104, and a controller 114 configured to control the pump(s) 120 and the active valve 118. For example, the controller 114 can control the pump(s) 120 to pump fluid between the fluid reservoir 102 and the inflatable member 104. The controller 114 can control the active valve 118 to transition between an open position and a closed position. The pump(s) 120 are configured to transfer fluid (on demand) to the inflatable member 104 at a relatively high pressure (e.g., up to about 20.0 PSI).

[0023] 1B illustrates an example of the controller 114. The controller 114 can include a printed circuit board assembly (PCBA) 140. The PCBA 140 can include a communications module 142 configured to receive and process (e.g., interpret) external signals, an on-board sensor 144 configured to detect pressure measurements from the pressure sensor 130, a processor 146, a memory device 148, one or more drivers 150 to drive the pump(s) 120 and / or the active valve(s) 118, and a power system 152. In some examples, the on-board sensor 144 includes an accelerometer configured to detect patient movement and / or position.

[0024] The communication module 142 may include one or more communication circuits configured to receive an external signal. In some examples, the communication module 142 is a Bluetooth communication circuit capable of receiving and processing a Bluetooth signal. In some examples, the communication module 142 is an NFC communication circuit capable of receiving and processing an NFC signal. In some examples, the communication module 142 is a magnetic communication circuit capable of receiving and processing a signal from a magnetic sensing circuit. In some examples, the communication module 142 is a radio frequency (RF) communication circuit capable of receiving and processing a high frequency RF signal. In some examples, the communication module 142 is a low frequency inductive communication circuit capable of receiving and processing a low frequency inductive signal. In some examples, the communication module 142 is an ultrasonic communication circuit capable of receiving and processing an ultrasonic signal. In some examples, the communication module 142 is a capacitive communication circuit capable of receiving and processing a capacitance-based signal. In some examples, the communication module 142 is an acoustic processing circuit capable of receiving and processing an acoustic signal.

[0025] The processor 146 can determine that an inflation cycle (and / or deflation cycle) has been activated based on an external signal and / or pressure measurements and can control the pump(s) 120 and the active valve 118 via one or more drivers 150 to transfer fluid between the fluid reservoir 102 and the inflatable member 104. The processor 146 can be any type of controller configured to control the operation of the pump(s) 120 and the active valve(s) 118. The processor 146 can be formed in a substrate configured to execute one or more machine-executable instructions, or software, firmware, or a combination thereof. The processor 146 can be semiconductor-based, i.e., can include semiconductor material capable of executing digital logic. The processor 146 can be communicatively coupled to drivers for the active valve(s) 118, the pump(s) 120, and the pressure sensor(s) 130.

[0026] The memory device 148 can store information in a format readable and / or executable by the processor 146. The memory device 148 can store executable instructions that, when executed by the processor 146, cause the processor 146 to perform certain operations described herein. The processor 146 can receive data via the pressure sensor(s) 130 and / or the external device 101 and control the active valve(s) 118 and / or the pump(s) 120 by sending control signals to the active valve(s) 118 and / or the pump(s) 120. The memory device 148 can store control parameters that a user and / or a physician can set or change using the external device 101. In some examples, the memory device 148 can store a maximum pressure threshold and / or a partial inflation threshold. A user or a physician can update the control parameters using the external device 101, and the control parameters can be updated in the memory device 148 after communicating to the controller 114. In some examples, the controller 114 may store usage statistics in the memory device 148. The usage statistics may include one or more statistics regarding the use of the inflatable penile prosthesis 100.

[0027] In some examples, as shown in FIGURE 1C, the controller 114 includes a microcontroller 154. In some examples, as shown in FIGURE 1D, the processor 146 includes a state machine 156. The state machine 156 may be implemented by one or more field programmable gate arrays 158 and / or one or more application specific integrated circuits 160. As shown in FIGURE 1E, the state machine 156 may transition between a number of states, such as a wait state 162 in which the inflatable member 104 is in a deflated state, an inflate state 164 in which the inflatable member 104 is inflated to a target pressure, a hold state 166 in which the pressure is held at the target pressure, and a deflate state 168 in which the inflatable member is deflated.

[0028] In some examples, as shown in FIG. 1F, the power system 152 includes a primary battery 170. In some examples, the power system 152 includes an energy storage 172. The energy storage 172 can include one or more capacitors. In some examples, the power system 152 includes a rechargeable battery 174. In some examples, the power system 152 includes a direct power interface 176. In some examples, low frequency technology (e.g., inductive power) can charge or directly power the inflatable penile prosthesis 100 while enabling operation. The external charger can be a portable device or a static device such as a flat encapsulated coil (e.g., on a chair seat or mattress). In some examples, NFC transmission can charge or directly power the inflatable penile prosthesis 100 while enabling operation. In some examples, VHF and UHF communication can charge or directly power the inflatable penile prosthesis 100 while enabling operation. In some examples, capacitive coupling techniques enable actuation and allow the inflatable penile prosthesis 100 to be charged or directly powered.

[0029] In some examples, the electronic pump assembly 106 includes an antenna 112 configured to wirelessly transmit (and receive) wireless signals to (from) the external device 101 (or multiple external devices 101). The wireless signals can be Bluetooth signals, NFC signals, magnetic signals, high frequency RF signals, low frequency inductive signals, ultrasonic signals, and / or capacitive-based signals. In some examples, a user can control the inflation or deflation cycle without the use of the external device 101. For example, the electronic pump assembly 106 can include an acoustic sensor that can detect an acoustic signal (e.g., tapping) that can enact an inflation or deflation cycle. In some examples, a user can squeeze the inflatable member 104, and the pressure sensor 130 can detect a pressure spike in the inflatable member 104 to activate an inflation cycle.

[0030] The external device 101 can be any type of component capable of communicating with the electronic pump assembly 106. The external device 101 can be a computer, a custom device, a smart phone, a tablet, a pendant, a key fob, etc. In some examples, the external device 101 includes one or more devices associated with a user of the inflatable penile prosthesis and one or more devices associated with a physician. The external device 101 can be an NFC device, a Bluetooth device, a magnetic device configured to generate a magnetic field, a radio frequency (RF) device configured to generate a high frequency signal, an induction device configured to generate a low frequency induction signal, an ultrasound device configured to generate an ultrasound signal, or a capacitive device configured to generate a capacitance when placed against a plate on the electronic pump assembly.

[0031] A user can control the inflatable penile prosthesis 100 using the external device 101. A user can inflate or deflate the inflatable member 104 using the external device 101. For example, the external device 101 can send a wireless signal (received via the antenna 112) to the electronic pump assembly 106 to initiate an inflation cycle in response to a user activating the inflation cycle using the external device 101, and the controller 114 can control the active valve(s) 118 and the pump(s) 120 to inflate the inflatable member 104 to a target inflation pressure. In some examples, the controller 114 can transition the active valve to a closed position and activate the pump(s) to move fluid from the fluid reservoir 102 to the inflatable member 104. The controller 114 can activate the pump(s) 120 according to a pump frequency. In some examples, the pumping architecture is designed to minimize or avoid audible frequencies. Humans can perceive a frequency range of 50 Hz to 19 kHz.

[0032] In response to a user activating a deflation cycle using the external device 101, the external device 101 can transmit a wireless signal (received via the antenna 112) to the electronic pump assembly 106 to initiate a deflation cycle, and the controller 114 can control the active valve(s) 118 (and, in some examples, one or more of the pumps 120) to transfer fluid from the inflatable member 104 to the fluid reservoir 102. For example, the controller 114 can control the active valve 118 to move to an open position to allow fluid to be transferred from the inflatable member 104 to the fluid reservoir 102. In some examples, the controller 114 can control the one or more pumps 120 to further transfer fluid from the inflatable member 104 to the fluid reservoir 102 during a deflation cycle. In some examples, fluid is returned during a deflation cycle until the pressure in the inflatable member 104 reaches a partial inflation threshold. In some examples, the controller 114 can automatically determine when to initiate a contraction cycle and thereby control the active valve(s) 118 (and, in some examples, the pump(s) 120) to return fluid to the fluid reservoir 102.

[0033] In some examples, the electronic pump assembly 106 includes a single pump 120, such as pump 120-1. The pump 120-1 can be arranged in parallel with the active valve 118. In some examples, the electronic pump assembly 106 includes multiple pumps 120. For example, the pump 120 can include pump 120-1 and pump 120-2. In some examples, the pump 120-1 is arranged in a fluid passage 125 used to fill the inflatable member 104 (e.g., during an expansion cycle). In some examples, the pump 120-2 is arranged in a parallel fluid passage 127 used to fill the inflatable member 104 (e.g., during an expansion cycle). In some examples, the pump 120-2 is arranged in parallel with the pump 120-1. The pump 120-1 can transport fluid according to a first flow rate, and the pump 120-1 can transport fluid according to a second flow rate. In some examples, the first flow rate is substantially the same as the second flow rate. In some examples, the first flow rate is different from the second flow rate.

[0034] In some examples, the pump 120 can include a pump disposed in series with the active valve 118. The pump can transfer fluid from the inflatable member 104 to the fluid reservoir 102 (e.g., during a deflation cycle). For example, the controller 114 can actuate the active valve 118 to an open position during a deflation cycle and actuate the pump to transfer fluid from the inflatable member 104 to the fluid reservoir 102. In some examples, the pump can transfer fluid according to a third flow rate. In some examples, the third flow rate is less than the first flow rate and / or the second flow rate. In some examples, the electronic pump assembly 106 can include one or more pumps 120 in series and one or more pumps 120 in parallel. In some examples, the pump 120 can include one or more pumps 120 in series with one or more other pumps 120. For example, one or more pumps 120 can be in series with pump 120-1. In some examples, one or more pumps 120 may be in series with pump 120-2.

[0035] Each pump 120 is an electronically controlled pump. The controller 114 can electronically control each pump 120. For example, each pump 120 can be connected to the controller 114 to receive a signal to operate the respective pump 120. The pumps 120 can be unidirectional, capable of transferring fluid from the fluid reservoir 102 to the inflatable member 104 (or from the inflatable member 104 to the fluid reservoir 102). In some examples, the pumps 120 are bidirectional, capable of transferring fluid from the fluid reservoir 102 to the inflatable member 104 and from the inflatable member 104 to the fluid reservoir 102. In some examples, the pumps 120 are either unidirectional or bidirectional. In some examples, the pumps 120 include a combination of one or more unidirectional pumps and one or more bidirectional pumps.

[0036] In some examples, the pump 120 is an electromagnetic pump that uses electromagnetism to move fluid between the fluid reservoir 102 and the inflatable member 104 .

[0037] In some examples, the pump 120 is a piezoelectric pump. In some examples, the piezoelectric pump can be a diaphragm micropump that uses actuation of a diaphragm to drive fluid. In some examples, the piezoelectric pump can include one or more piezoelectric pumps (e.g., piezoelectric elements) that can be implemented by a substrate layer of high-voltage piezoelectric elements (e.g., a single substrate layer) or multiple substrate layers of low-voltage piezoelectric elements (e.g., stacked substrate layers). In some examples, the pump 120 includes multiple micropumps (e.g., piezoelectrically driven micropumps) disposed on one or more substrates (e.g., wafers). In some examples, the micropump includes a silicon-based material. In some examples, the micropump includes a metal (e.g., steel)-based material. In some examples, the pump 120 is non-mechanical (e.g., does not include moving parts).

[0038] In some examples, in the case of multiple pumps 120, each pump 120 can 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, pumps 120 can include different types of piezoelectric pumps or different types of electromagnetic pumps. Pump 120-1 can be a piezoelectric pump having a first number of micropumps and pump 120-2 can be a piezoelectric pump having a second number of micropumps.

[0039] The pump 120 may include one or more passive check valves. The passive check valve(s) may help maintain pressure in the inflatable member 104. In some examples, the pump 120 may include a single passive check valve. In some examples, the pump 120 may include multiple passive check valves, such as two passive check valves (e.g., arranged in series with one another) or more than two passive check valves. The passive check valve(s) of each pump 120 may not be directly controlled by the controller 114, but rather may be controlled based on the pressure between the inflatable member 104 and the fluid reservoir 102. The passive check valve(s) may transition between an open position (where fluid may flow through the passive check valve(s)) and a closed position (where fluid may not flow through the passive check valve(s)). In some examples, for pump 120-1 and pump 120-2, the passive check valve(s) are forward biased to allow passive flow through the passive check valve(s) in a direction from fluid reservoir 102 to inflatable member 104 while being in a closed position in a flow direction from inflatable member 104 to fluid reservoir 102. In some examples, the passive check valve(s) transition to a closed position in response to a positive pressure between inflatable member 104 and fluid reservoir 102. In some examples, the passive check valve(s) transition to an open position in response to a negative pressure between inflatable member 104 and fluid reservoir 102.

[0040] The active valves 118 can be electronically controlled valves. The active valves 118 can be electronically controlled by the controller 114. For example, the active valves 118 can be connected to the controller 114 to receive signals to transition the active valves 118 between an open position in which fluid flows through the active valves 118 and a closed position in which fluid cannot flow through the active valves 118. In some examples, the active valves 118 include a diaphragm and a ring member (e.g., an O-ring). In some examples, in the closed position, an interface between the diaphragm and the ring member prevents a flow of fluid. In some examples, in the open position, the diaphragm is released (e.g., spaced apart) from the ring member to allow fluid to flow through the active valves 118. The active valves 118 can be bidirectional. Each active valve 118 can be piezoelectric or electromagnetic diaphragm actuated. In some examples, the active valves 118 are disposed in a fluid passage 124 used to empty the inflatable member 104 (e.g., during a deflation cycle). In some examples, the active valve 118 can be transitioned to a closed position to retain (e.g., substantially retain) pressure in the inflatable member 104. In some examples, the active valve 118 can be transitioned to an open position to return fluid to the fluid reservoir 102, relieving pressure in the inflatable member 104 and / or allowing flow back to the inflatable member 104. In some examples, the active valve 118 can be used to retain (e.g., substantially retain) the partial inflation pressure.

[0041] In some examples, the electronic pump assembly 106 includes a single active valve 118. In some examples, the electronic pump assembly 106 includes multiple active valves 118. In some examples, there can be one or more additional active valves 118 in series with pump 120-1 and / or pump 120-2. In some examples, the electronic pump assembly 106 does not include an active valve 118. In some examples, one or more of the pumps 120 can act as a valve, thus avoiding the use of an active valve 118. In some examples, an additional active valve 118 (e.g., a series active valve 118) can be disposed in a fluid path portion connected to the fluid reservoir 102. In some examples, an additional active valve 118 (e.g., a series active valve 118) can be disposed in a fluid path portion connected to the inflatable member 104. These additional active valves 118 can reduce leakage when at full inflation pressure or partial inflation pressure.

[0042] The electronic pump assembly 106 may include one or more pressure sensors 130 configured to sense the pressure of the inflatable penile prosthesis 100. In some examples, the electronic pump assembly 106 includes a single pressure sensor 130. In some examples, the electronic pump assembly 106 may include multiple pressure sensors 130. The pressure sensor 130 is configured to measure the pressure of the inflatable member 104. The controller 114 may receive pressure measurements from the pressure sensor 130 according to the pressure sensing rate. Each pressure measurement may indicate the pressure of the inflatable member 104 at the time of the pressure measurement. In some examples, the pressure sensor 130 is configured to measure the pressure of the reservoir 102. The pressure measurements may be used to control the active valve(s) 118 to prevent (or inhibit) the transfer of fluid to the inflatable member 104.

[0043] The electronic pump assembly 106 can include a hermetic enclosure 108 that encloses the components of the electronic pump assembly 106. The hermetic enclosure 108 can be an airtight (or substantially airtight) enclosure. The hermetic enclosure 108 can include one or more metal-based materials. In some examples, the hermetic enclosure 108 is a titanium enclosure. In some examples, the only material in contact with the patient is titanium. In some examples, the hermetic enclosure 108 includes a non-metal-based material, such as a ceramic. In some examples, the hermetic enclosure 108 defines a feedthrough 136 (e.g., a hermetic feedthrough, an electrical feedthrough, a feedthrough connector, etc.) for receiving / transmitting wireless signals to / from the external device 101. In some examples, the feedthrough 136 includes a metal-based material and an insulator-based material (e.g., a ceramic).

[0044] The electronic pump assembly 106 may include a sealed fluid chamber 110 disposed inside the sealed enclosure 108. The sealed fluid chamber 110 may be an independent airtight (or substantially airtight) container present within the sealed enclosure 108. The sealed fluid chamber 110 may include one or more metal-based materials. In some examples, the sealed fluid chamber 110 is a titanium container. In some examples, the sealed fluid chamber 110 includes one or more non-metal-based materials (e.g., ceramic). 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). The sealed fluid chamber 110 may isolate the fluid from the electronics. In other words, the electronics section may be isolated (e.g., completely isolated) from the fluid via the sealed fluid chamber 110. The sealed fluid chamber 110 may be fluidly connected to the fluid reservoir 102 and the inflatable member 104. The sealed fluid chamber 110 can include active valve(s) 118, pump(s) 120, and pressure sensor(s) 130. In some examples, the sealed fluid chamber 110 defines a feedthrough 138 (e.g., a hermetic feedthrough, an electrical feedthrough, a feedthrough connector, etc.) to the controller 114 for receiving / transmitting signals to / from the controller 114. In some examples, the sealed fluid chamber 110 disposed within the sealed enclosure 108 forms a dual sealed system. In some examples, the electronic pump assembly 106 includes only one sealed enclosure (e.g., the sealed enclosure 108).

[0045] 2 illustrates an inflatable penile prosthesis 200 having an electronic pump assembly 206 configured to communicate with an external device 201 (e.g., a Bluetooth device) using a Bluetooth wireless connection, according to one embodiment. Inflatable penile prosthesis 200 may be an example of inflatable penile prosthesis 100 of FIGS. 1A-1F and may include any of the details described with reference to those figures.

[0046] A user can use the external device 201 to cause the electronic pump assembly 206 to inflate or deflate the inflatable member 204. For example, a user can operate the external device 201 to generate a Bluetooth signal 209 that can activate an inflation cycle. In some examples, a user can operate the external device 201 to generate a Bluetooth signal 209 that can activate a deflation cycle. Bluetooth is a short-range wireless standard utilized to exchange data between devices over short distances using UHF radio waves in the ISM band of 2.402 GHz to 2.48 GHz. Bluetooth low energy (BLE) can be particularly suited for implantable devices that use primary batteries. A Bluetooth device (e.g., the external device 201), such as a smartphone or a custom-designed controller, can be used to control the inflatable penile prosthesis 200 from outside the body.

[0047] The electronic pump assembly 206 is configured to transfer fluid between the fluid reservoir 202 and the inflatable member 204. The electronic pump assembly 206 includes a sealed enclosure 208, an antenna 212, and a feedthrough 236. The electronic pump assembly 206 includes a controller 214 contained within the sealed enclosure 208. The antenna 212 is capable of receiving (and transmitting) Bluetooth signals 209 from / to the Bluetooth device 201. The antenna 212 is connected to the controller 214 via the feedthrough 236.

[0048] The controller 214 includes a printed circuit board assembly 240 having a communications module 242 (e.g., Bluetooth transceiver circuitry), on-board sensors 244, a processor 246 (with memory), one or more drivers 250, and a power system 252. In some examples, the processor 246 is a microprocessor. In some examples, the processor 246 is a state machine implemented by a field programmable gate array and / or an application specific integrated circuit. The power system 252 can include a primary battery. In some examples, the power system 252 includes energy storage (e.g., one or more capacitors). In some examples, the power system 252 includes a rechargeable battery. In some examples, the power system 252 includes a direct power interface.

[0049] The electronic pump assembly 206 includes a sealed fluid chamber 210 disposed within a sealed enclosure 208. The sealed fluid chamber 210 includes a pressure sensor 230 configured to monitor the pressure of the inflatable member 204, the one or more active valves 218, and the one or more pumps 220. An on-board sensor 244 is connected to the pressure sensor 230 via a feedthrough 238 such that the controller 214 can receive pressure measurements from the pressure sensor 230. The active valve(s) 218 ​​and the pumps 220 are connected to a driver(s) 250 via the feedthrough 238 to receive signals to activate / deactivate the pump(s) 220 and / or open / close the active valve(s) 218. The electronics section can be isolated (e.g., completely isolated) from the fluid via the sealed fluid chamber 210.

[0050] 3 illustrates an inflatable penile prosthesis 300 having an electronic pump assembly 306 configured to communicate with an external device 301 (e.g., an NFC device) using an NFC wireless connection, according to one embodiment. Inflatable penile prosthesis 300 may be an example of inflatable penile prosthesis 100 of FIGS. 1A-1F and may include any of the details described with reference to those figures.

[0051] A user can use the external device 301 to cause the electronic pump assembly 306 to inflate or deflate the inflatable member 304. For example, a user can manipulate the external device 301 to generate an NFC signal 309 that can activate an inflation cycle. In some examples, a user can manipulate the external device 301 to generate an NFC signal 309 that can activate a deflation cycle.

[0052] Near Field Communication (NFC) is a set of communication protocols for communication between two electronic devices over distances of up to 4 cm, such as those used in contactless payment systems. An NFC device (e.g., external device 301), such as a smartphone or a custom-designed controller, can be used to control an implanted device from outside the body.

[0053] The electronic pump assembly 306 is configured to transfer fluid between the fluid reservoir 302 and the inflatable member 304. The electronic pump assembly 306 includes a sealed enclosure 308, an antenna 312, and a feedthrough 336. The electronic pump assembly 306 includes a controller 314 contained within the sealed enclosure 308. The antenna 312 is capable of receiving (and transmitting) NFC signals 309 from / to the NFC device 301. The antenna 312 is connected to the controller 314 via the feedthrough 336.

[0054] The controller 314 includes a printed circuit board assembly 340 having a communications module 342 (e.g., an NFC transceiver circuit), an on-board sensor 344, a processor 346 (with memory), one or more drivers 350, and a power system 352. In some examples, the processor 346 is a microprocessor. In some examples, the processor 346 is a state machine implemented by a field programmable gate array and / or an application specific integrated circuit. The power system 352 can include a primary battery. In some examples, the power system 352 includes energy storage (e.g., one or more capacitors). In some examples, the power system 352 includes a rechargeable battery. In some examples, the power system 352 includes a direct power interface.

[0055] The electronic pump assembly 306 includes a sealed fluid chamber 310 disposed within a sealed enclosure 308. The sealed fluid chamber 310 includes a pressure sensor 330 configured to monitor the pressure of the inflatable member 304, one or more active valves 318, and one or more pumps 320. An on-board sensor 344 is connected to the pressure sensor 330 via a feedthrough 338 such that the controller 314 can receive pressure measurements from the pressure sensor 330. The active valve(s) 318 and pumps 320 are connected to a driver(s) 350 via the feedthrough 338 to receive signals to activate / deactivate the pump(s) 320 and / or open / close the active valve(s) 318. The electronics section can be isolated (e.g., completely isolated) from the fluid via the sealed fluid chamber 310.

[0056] In some examples, NFC transmissions enable actuation as well as charging or directly powering the electronic pump assembly 306. In some examples, the antenna 312 includes one or more directional antennas. Charging can be accomplished by routing NFC transmissions to a power system 352 (e.g., a rechargeable battery, a power storage device).

[0057] 4 illustrates an inflatable penile prosthesis 400 having an electronic pump assembly 406 configured to communicate with an external device 401 using a magnetic field, according to one embodiment. Inflatable penile prosthesis 400 may be an example of inflatable penile prosthesis 100 of FIGS. 1A-1F and may include any of the details described with reference to those figures.

[0058] A user can use an external device 401 to cause the electronic pump assembly 406 to inflate or deflate the inflatable member 404. For example, a patient can use a magnet to initiate an inflation or deflation cycle. A magnet can be provided to the patient, and the electronic pump assembly 406 includes a magnet detection switch 480 configured to detect the presence of a magnetic field.

[0059] The electronic pump assembly 406 is configured to transfer fluid between the fluid reservoir 402 and the inflatable member 404. The electronic pump assembly 406 includes a sealed enclosure 408. The electronic pump assembly 406 includes a controller 414 contained within the sealed enclosure 408.

[0060] The controller 414 includes a printed circuit board assembly 440 having a magnet sensing switch 480 configured to close in the presence of a magnetic field provided by the external device 401, a communication module 442 (e.g., receiving a voltage from the magnet sensing switch 480), an on-board sensor 444, a processor 446 (with memory), one or more drivers 450, and a power system 452. In some examples, the processor 446 is a microprocessor. In some examples, the processor 446 is a state machine implemented by a field programmable gate array and / or an application specific integrated circuit. The power system 452 can include a primary battery. In some examples, the power system 452 includes energy storage (e.g., one or more capacitors). In some examples, the power system 452 includes a rechargeable battery. In some examples, the power system 452 includes a direct power interface.

[0061] The electronic pump assembly 406 includes a sealed fluid chamber 410 disposed within a sealed enclosure 408. The sealed fluid chamber 410 includes a pressure sensor 430 configured to monitor the pressure of the inflatable member 404, one or more active valves 418, and one or more pumps 420. An on-board sensor 444 is connected to the pressure sensor 430 via a feedthrough 438 such that the controller 414 can receive pressure measurements from the pressure sensor 430. The active valve(s) 418 and the pumps 420 are connected to a driver(s) 450 via the feedthrough 438 to receive signals to activate / deactivate the pumps 420 and / or open / close the active valve(s) 418. The electronics section can be isolated (e.g., completely isolated) from the fluid via the sealed fluid chamber 410.

[0062] 5 illustrates an inflatable penile prosthesis 500 having an electronic pump assembly 506 configured to communicate with an external device 501 using high frequency wireless signals, according to one embodiment. Inflatable penile prosthesis 500 may be an example of inflatable penile prosthesis 100 of FIGS. 1A-1F and may include any of the details described with reference to those figures.

[0063] A user can use external device 501 to cause electronic pump assembly 506 to inflate or deflate inflatable member 504. For example, a user can operate external device 401 to generate a high frequency radio signal that can activate an inflation cycle. In some examples, a user can operate external device 301 to generate a high frequency radio signal that can activate a deflation cycle.

[0064] High frequency transmission can be used to operate the inflatable penile prosthesis 500. Frequencies can range from kHz to GHz. For most short and medium range operation, inductive coupling, resonant inductive coupling and microwaves can be utilized. In some examples, the external device 501 includes a custom RF controller that can be used to control the inflatable penile prosthesis 500 from outside the body.

[0065] The electronic pump assembly 506 is configured to transfer fluid between the fluid reservoir 502 and the inflatable member 504. The electronic pump assembly 506 includes a sealed enclosure 508, an antenna 512, and a feedthrough 536. The electronic pump assembly 506 includes a controller 514 contained within the sealed enclosure 508. The antenna 512 is capable of receiving (and transmitting) RF signals from / to the external device 501. The antenna 512 is connected to the controller 514 via the feedthrough 536.

[0066] The controller 514 includes a printed circuit board assembly 540 having a communications module 542 (e.g., RF transceiver circuitry), an on-board sensor 544, a processor 546 (with memory), one or more drivers 550, and a power system 552. In some examples, the processor 546 is a microprocessor. In some examples, the processor 546 is a state machine implemented by a field programmable gate array and / or an application specific integrated circuit. The power system 552 can include a primary battery. In some examples, the power system 552 includes energy storage (e.g., one or more capacitors). In some examples, the power system 552 includes a rechargeable battery. In some examples, the power system 552 includes a direct power interface.

[0067] The electronic pump assembly 506 includes a sealed fluid chamber 510 disposed within a sealed enclosure 508. The sealed fluid chamber 510 includes a pressure sensor 530 configured to monitor the pressure of the inflatable member 504, the one or more active valves 518, and the one or more pumps 520. An on-board sensor 544 is connected to the pressure sensor 530 via a feedthrough 538 such that the controller 514 can receive pressure measurements from the pressure sensor 530. The active valve(s) 518 and the pumps 520 are connected to a driver(s) 550 via the feedthrough 538 to receive signals to activate / deactivate the pumps 520 and / or open / close the active valve(s) 518. The electronics section can be isolated (e.g., completely isolated) from the fluid via the sealed fluid chamber 510.

[0068] VHF and UHF transmissions can operate and charge or directly power the inflatable penile prosthesis 500. Typically, the frequencies are in the MHz to GHz range and incorporate resonant or non-resonant modes. Near-field and mid-field techniques can also be incorporated. In some examples, the antenna 512 includes one or more directional antennas to improve power transfer.

[0069] 6 illustrates an inflatable penile prosthesis 600 having an electronic pump assembly 606 configured to communicate with an external device 601 using a low frequency inductive signal, according to one embodiment. Inflatable penile prosthesis 600 may be an example of inflatable penile prosthesis 100 of FIGS. 1A-1F and may include any of the details described with reference to those figures.

[0070] A user can use the external device 601 to cause the electronic pump assembly 606 to inflate or deflate the inflatable member 604. In some examples, the external device 601 includes an induction controller. A user can operate the external device 601 to generate an induction signal that can activate an inflation cycle. In some examples, a user can operate the external device 601 to generate an induction signal that can activate a deflation cycle. Low frequency technology can operate the inflatable penile prosthesis 600. Typically, the frequency is in the kHz range and incorporates resonant or non-resonant modes.

[0071] The electronic pump assembly 606 is configured to transfer fluid between the fluid reservoir 602 and the inflatable member 604. The electronic pump assembly 606 includes a sealed enclosure 608. The electronic pump assembly 606 includes a controller 614 contained within the sealed enclosure 608.

[0072] The controller 614 includes a printed circuit board assembly 640 having an inductive antenna, a communication module 642 (e.g., transceiver circuitry), an on-board sensor 644, a processor 646 (with memory), one or more drivers 650, and a power system 652. In some examples, the processor 646 is a microprocessor. In some examples, the processor 646 is a state machine implemented by a field programmable gate array and / or an application specific integrated circuit. The power system 652 can include a primary battery. In some examples, the power system 652 includes energy storage (e.g., one or more capacitors). In some examples, the power system 652 includes a rechargeable battery. In some examples, the power system 652 includes a direct power interface.

[0073] The electronic pump assembly 606 includes a sealed fluid chamber 610 disposed within a sealed enclosure 608. The sealed fluid chamber 610 includes a pressure sensor 630 configured to monitor the pressure of the inflatable member 604, one or more active valves 618, and one or more pumps 620. An on-board sensor 644 is connected to the pressure sensor 630 via a feedthrough 638 such that the controller 614 can receive pressure measurements from the pressure sensor 630. The active valve(s) 618 and pumps 620 are connected to a driver(s) 650 via the feedthrough 638 to receive signals to activate / deactivate the pump(s) 620 and / or open / close the active valve(s) 618. The electronics section can be isolated (e.g., completely isolated) from the fluid via the sealed fluid chamber 610.

[0074] Low frequency technology allows actuation and the ability to charge or directly power the inflatable penile prosthesis 600. Typically, the frequency is in the kHz range and incorporates resonant or non-resonant modes.

[0075] 7 illustrates an inflatable penile prosthesis 700 having an electronic pump assembly 706 configured to communicate with an external device 701 using ultrasonic signals, according to one embodiment. Inflatable penile prosthesis 700 may be an example of inflatable penile prosthesis 100 of FIGS. 1A-1F and may include any of the details described with reference to those figures.

[0076] A user can use the external device 701 to cause the electronic pump assembly 706 to inflate or deflate the inflatable member 704. In some examples, the external device 701 includes an ultrasonic transceiver configured to communicate with an ultrasonic antenna 788 on the controller 714 of the electronic pump assembly 706. A user can operate the external device 701 to generate an ultrasonic signal that can actuate an inflation cycle. In some examples, a user can operate the external device 701 to generate an ultrasonic signal that can actuate a deflation cycle. The ultrasonic transmission can be used to actuate the inflatable penile prosthesis 700 using piezoelectric technology.

[0077] The electronic pump assembly 706 is configured to transfer fluid between the fluid reservoir 702 and the inflatable member 704. The electronic pump assembly 706 includes a sealed enclosure 708. The electronic pump assembly 706 includes a controller 714 contained within the sealed enclosure 708.

[0078] The controller 714 includes a printed circuit board assembly 740 having an ultrasonic antenna 788, a communications module 742 (e.g., transceiver circuitry), an on-board sensor 744, a processor 746 (with memory), one or more drivers 750, and a power system 752. In some examples, the processor 746 is a microprocessor. In some examples, the processor 746 is a state machine implemented by a field programmable gate array and / or an application specific integrated circuit. The power system 752 can include a primary battery. In some examples, the power system 752 includes energy storage (e.g., one or more capacitors). In some examples, the power system 752 includes a rechargeable battery. In some examples, the power system 752 includes a direct power interface.

[0079] The electronic pump assembly 706 includes a sealed fluid chamber 710 disposed within a sealed enclosure 708. The sealed fluid chamber 710 includes a pressure sensor 730 configured to monitor the pressure of the inflatable member 704, one or more active valves 718, and one or more pumps 720. An on-board sensor 744 is connected to the pressure sensor 730 via a feedthrough 738 such that the controller 714 can receive pressure measurements from the pressure sensor 730. The active valve(s) 718 and pumps 720 are connected to a driver(s) 750 via the feedthrough 738 to receive signals to activate / deactivate the pump(s) 720 and / or open / close the active valve(s) 718. The electronics section can be isolated (e.g., completely isolated) from the fluid via the sealed fluid chamber 710. In some examples, ultrasonic technology can be used to remotely power a device (e.g., to power the device directly) and / or to remotely recharge its rechargeable battery or power storage device.

[0080] 8 illustrates an inflatable penile prosthesis 800 having an electronic pump assembly 806 configured to actuate inflation or deflation cycles based on a gripping signal sensed by a pressure sensor 830, according to one embodiment. The inflatable penile prosthesis 800 may be an example of the inflatable penile prosthesis 100 of FIGS. 1A-1F and may include any of the details described with reference to those figures.

[0081] A gripping action on the inflatable member 804 can compress the inflatable member 804 to trigger an inflation cycle. In some instances, the inflatable penile prosthesis 800 can be configured without the use of an external device. When deflation is required, the controller 814 can detect a sequence of gripping actions to avoid false signals. Optionally, deactivation can be triggered by another external device or timer. The pressure sensor 830 detects a signal, which is processed by the on-board sensor 844.

[0082] The electronic pump assembly 806 is configured to transfer fluid between the fluid reservoir 802 and the inflatable member 804. The electronic pump assembly 806 includes a sealed enclosure 808. The electronic pump assembly 806 includes a controller 814 that is contained within the sealed enclosure 808.

[0083] The controller 814 includes a printed circuit board assembly 840 having a communications module 842 (e.g., transceiver circuitry), on-board sensors 844, a processor 846 (with memory), one or more drivers 850, and a power system 852. In some examples, the processor 846 is a microprocessor. In some examples, the processor 846 is a state machine implemented by a field programmable gate array and / or an application specific integrated circuit. The power system 852 can include a primary battery. In some examples, the power system 852 includes energy storage (e.g., one or more capacitors). In some examples, the power system 852 includes a rechargeable battery. In some examples, the power system 852 includes a direct power interface.

[0084] The electronic pump assembly 806 includes a sealed fluid chamber 810 disposed within a sealed enclosure 808. The sealed fluid chamber 810 includes a pressure sensor 830 configured to monitor the pressure of the inflatable member 804, the one or more active valves 818, and the one or more pumps 820. An on-board sensor 844 is connected to the pressure sensor 830 via a feedthrough 838 such that the controller 814 can receive pressure measurements from the pressure sensor 830. The active valve(s) 818 and the pumps 820 are connected to a driver(s) 850 via the feedthrough 838 to receive signals to activate / deactivate the pump(s) 820 and / or open / close the active valve(s) 818. The electronics section can be isolated (e.g., completely isolated) from the fluid via the sealed fluid chamber 810.

[0085] 9 illustrates an inflatable penile prosthesis 900 having an electronic pump assembly 906 configured to communicate with an external device 901 using capacitive signals, according to one embodiment. The inflatable penile prosthesis 900 may be an example of the inflatable penile prosthesis 100 of FIGS. 1A-1F and may include any of the details described with reference to those figures.

[0086] In some examples, the external device 901 is a capacitive device (e.g., having a first plate 990 of a capacitor 991) and the electronic pump assembly 906 includes a second plate 992 of the capacitor 991. For example, the first plate 990 is part of the external device 901 and the second plate 992 is implanted within the patient's body. When the first plate 990 is placed in close proximity (e.g., within a threshold distance) to the second plate 992, the controller 914 (via the feedthrough 936) can receive a capacitive signal to inflate or deflate the inflatable member 904.

[0087] The electronic pump assembly 906 is configured to transfer fluid between the fluid reservoir 902 and the inflatable member 904. The electronic pump assembly 906 includes a sealed enclosure 908, a first plate 992, and a feedthrough 936 (which allows for receipt of a capacitive signal at the controller 914). The electronic pump assembly 906 includes the controller 914 contained within the sealed enclosure 908.

[0088] The controller 914 includes a printed circuit board assembly 940 having a communications module 942 (e.g., transceiver circuitry), on-board sensors 944, a processor 946 (with memory), one or more drivers 950, and a power system 952. In some examples, the processor 946 is a microprocessor. In some examples, the processor 946 is a state machine implemented by a field programmable gate array and / or an application specific integrated circuit. The power system 952 can include a primary battery. In some examples, the power system 952 includes energy storage (e.g., one or more capacitors). In some examples, the power system 952 includes a rechargeable battery. In some examples, the power system 952 includes a direct power interface.

[0089] The electronic pump assembly 906 includes a sealed fluid chamber 910 disposed within a sealed enclosure 908. The sealed fluid chamber 910 includes a pressure sensor 930 configured to monitor the pressure of the inflatable member 904, one or more active valves 918, and one or more pumps 920. An on-board sensor 944 is connected to the pressure sensor 930 via a feedthrough 938 such that the controller 914 can receive pressure measurements from the pressure sensor 930. The active valve(s) 918 and the pumps 920 are connected to a driver(s) 950 via the feedthrough 938 to receive signals to activate / deactivate the pump(s) 920 and / or open / close the active valve(s) 918. The electronics section can be isolated (e.g., completely isolated) from the fluid via the sealed fluid chamber 910.

[0090] Capacitive coupling techniques allow actuation and can charge or directly power the inflatable penile prosthesis 900. The external device 901 has a plate (e.g., a first plate 990) that is placed adjacent to the skin. A second plate 992 is embedded and can be part of a shallow implant just below the skin or a satellite transducer.

[0091] FIG. 10 illustrates an inflatable penile prosthesis 1000 having an electronic pump assembly 1006 configured to actuate an inflation or deflation cycle using an acoustic signal, according to one embodiment. The inflatable penile prosthesis 1000 may be an example of the inflatable penile prosthesis 100 of FIGS. 1A-1F and may include any of the details described with reference to those figures. An acoustic sensor 1094 may detect tapping on the abdomen to trigger inflation. In some examples, an acoustic signal may be used to trigger inflation or deflation.

[0092] The electronic pump assembly 1006 is configured to transfer fluid between the fluid reservoir 1002 and the inflatable member 1004. The electronic pump assembly 1006 includes a sealed enclosure 1008 and a feedthrough 1036 (which allows for detection of an acoustic signal by an acoustic sensor 1094). In some examples, the acoustic sensor 1094 is located outside the electronic pump assembly 1006 (e.g., opposite the feedthrough 1036). The electronic pump assembly 1006 includes a controller 1014 contained within the sealed enclosure 1008.

[0093] The controller 1014 includes a printed circuit board assembly 1040 having an acoustic sensor 1094, a communication module 1042 (e.g., transceiver circuitry), an on-board sensor 1044, a processor 1046 (with memory), one or more drivers 1050, and a power system 1052. In some examples, the processor 1046 is a microprocessor. In some examples, the processor 1046 is a state machine implemented by a field programmable gate array and / or an application specific integrated circuit. The power system 1052 can include a primary battery. In some examples, the power system 1052 includes energy storage (e.g., one or more capacitors). In some examples, the power system 1052 includes a rechargeable battery. In some examples, the power system 1052 includes a direct power interface.

[0094] The electronic pump assembly 1006 includes a sealed fluid chamber 1010 disposed within a sealed enclosure 1008. The sealed fluid chamber 1010 includes a pressure sensor 1030 configured to monitor the pressure of the inflatable member 1004, one or more active valves 1018, and one or more pumps 1020. An on-board sensor 1044 is connected to the pressure sensor 1030 via a feedthrough 1038 such that the controller 1014 can receive pressure measurements from the pressure sensor 1030. The active valve(s) 1018 and the pumps 1020 are connected to a driver(s) 1050 via the feedthrough 1038 to receive signals to activate / deactivate the pumps 1020 and / or open / close the active valve(s) 1018. The electronics section can be isolated (e.g., completely isolated) from the fluid via the sealed fluid chamber 1010.

[0095] FIG. 11 illustrates a schematic representation of an inflatable penile prosthesis 1100 having an electronic pump assembly 1106, according to one embodiment. The electronic pump assembly 1106 may include any of the features of the electronic pump assembly described with reference to the previous figures. The inflatable penile prosthesis 1100 may include a pair of inflatable cylinders 1110, the inflatable cylinders 1110 configured to be implanted in the penis. For example, one of the inflatable cylinders 1110 may be disposed on one side of the penis, and the other inflatable cylinder 1110 may be disposed on the other side of the penis. Each inflatable cylinder 1110 may include a first end 1124, a cavity or expansion chamber 1122, and a second end 1128 having a rear tip 1132.

[0096] At least a portion of the electronic pump assembly 1106 can be implanted within the patient's body. The electronic pump assembly 1106 can be attached to the inflatable cylinder 1110 by a pair of conduit connectors 1105 such that the electronic pump assembly 1106 is in fluid communication with the inflatable cylinder 1110. The electronic pump assembly 1106 can also be in fluid communication with the fluid reservoir 1102 via the conduit connector 1103. The fluid reservoir 1102 can be implanted in the abdomen of the user. The expansion chamber 1122 of the inflatable cylinder 1110 can be located within the penis. The first end 1124 of the inflatable cylinder 1110 can be located at least partially within the crown portion of the penis. The second end 1128 can be implanted in the patient's pubic region PR with the rear end 1132 proximate the pubic bone PB.

[0097] To implant the inflatable cylinder 1110, the surgeon first prepares the patient. In many cases, the surgeon makes an incision in the penile scrotum, for example, where the base of the penis meets the top of the scrotum. The surgeon can expand the patient's corpus cavernosum from the incision in the penile scrotum to prepare the patient to receive the inflatable cylinder 1110. The corpus cavernosum is one of two parallel columns of erectile tissue that form the dorsal portion of the penile body, for example, two elongated columns that extend the substantial length of the penis. The surgeon also expands two areas of the pubic area to prepare the patient to receive the second end 1128. The surgeon can measure the length of the corpus cavernosum from the incision and the expanded area of ​​the pubic area to determine the appropriate size of the inflatable cylinder 1110 to be implanted.

[0098] After the patient is prepared, the penile prosthesis 1100 is implanted in the patient. The tip of the first end 1124 of each inflatable cylinder 1110 can be attached to a suture. The other end of the suture can be attached to a needle (e.g., a Keith needle). The needle is inserted through the incision and the expanded corpus cavernosum. The needle is then pushed through the glans portion of the penis. The surgeon pulls up on the suture to pull the inflatable cylinder 1110 into the corpus cavernosum. This procedure is performed for each inflatable cylinder 1110 of the pair. Once the expansion chamber 1122 is in place, the surgeon can remove the suture from the tip. Next, the surgeon inserts the second end 1128. The surgeon inserts the rear end of the inflatable cylinder 1110 into the incision and advances the second end 1128 toward the pubic bone PB until each inflatable cylinder 1110 is in place. However, embodiments include various other implantation techniques.

[0099] A user can control the inflatable penile prosthesis 1100 using the external device 1101. In some examples, a user can use the external device 1101 to inflate or deflate the inflatable cylinder 1110. For example, in response to a user using the external device 1101 to activate an inflation cycle, the external device 1101 can transmit a wireless signal to the electronic pump assembly 1106 to initiate an inflation cycle that transfers fluid from the fluid reservoir 1102 to the inflatable cylinder 1110. In some examples, in response to a user using the external device 1101 to activate a deflation cycle, the external device 1101 can transmit a wireless signal to the electronic pump assembly 1106 to initiate a deflation cycle that transfers fluid from the inflatable cylinder 1110 to the fluid reservoir 1102. In some examples, during a deflation cycle, fluid is returned until the pressure in the inflatable cylinder 1110 reaches a partial inflation pressure.

[0100] 12 shows a flowchart 1200 illustrating example operations of a method for operating an electronic pump assembly of an inflatable penile prosthesis. The example operations of flowchart 1200 may be performed by any of the inflatable penile prostheses and / or electronic pump assemblies described herein.

[0101] Operation 1202 includes a controller of the electronic pump assembly detecting an external signal, the controller including a printed circuit board assembly, the printed circuit board assembly including a microprocessor or state machine. Operation 1204 includes determining to activate an inflation cycle of the inflatable penile prosthesis based on the external signal. Operation 1206 includes activating at least one of a pump or an active valve to transfer fluid from a fluid reservoir to the inflatable member. In some examples, the method includes charging a battery of the electronic pump assembly based on wireless transmissions received via an antenna of the electronic pump assembly. In some examples, the battery can be charged based on inductive transmissions, ultrasonic transmissions, NFC transmissions, high frequency RF transmissions, or capacitive wireless transmissions.

[0102] Detailed embodiments have been disclosed herein. However, it is understood that the disclosed embodiments are merely examples and can be embodied in various forms. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limitations, but merely as a basis for the claims and as a representative basis for teaching those skilled in the art that these embodiments can be variously employed in substantially any suitable detailed structure. Moreover, the terms and expressions used herein are not intended to be limiting, but are intended to provide an understandable description of the present disclosure.

[0103] The term "a" as used herein is defined as one or more than one. The term "another" as used herein is defined as at least a second or more. The terms "including" and / or "having" as used herein are defined as comprising (i.e., an open transition). The terms "coupled" or "moveably coupled" as used herein are defined as connected, although not necessarily directly mechanically.

[0104] In general, the embodiments relate to body implants. Hereinafter, the term patient or user can be used for a person who can benefit from the medical device or method disclosed in the present disclosure. For example, the patient can be a person in whose body the disclosed medical device or the method of operation of the medical device according to the present disclosure is implanted. For example, in some embodiments, the patient can be a human being.

[0105] While certain features of the described implementations have been described herein, many modifications, substitutions, changes and equivalents will occur to those skilled in the art, and it is therefore to be understood that the appended claims are intended to cover all such modifications and changes that are within the scope of the present embodiments.

Claims

1. 1. An inflatable penile prosthesis comprising: a fluid reservoir configured to hold a fluid; An inflatable member; an electronic pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member; the electronic pump assembly comprising: A pump, An active valve; a controller configured to receive an external signal to operate an expansion cycle and to control at least one of the pump or the active valve to transfer the fluid to the inflatable member; the controller includes a printed circuit board assembly, the printed circuit board assembly including a microprocessor or a state machine. Inflatable penile prosthesis.

2. the electronic pump assembly includes an antenna, the antenna configured to receive the external signal, the external signal including a Bluetooth signal; 2. The inflatable penile prosthesis of claim 1.

3. the electronic pump assembly includes an antenna, the antenna configured to receive the external signal, the external signal including a near field communication (NFC) signal; 2. The inflatable penile prosthesis of claim 1.

4. The printed circuit board assembly includes a power source, the power source being configured to be charged by wireless transmission.

4. An inflatable penile prosthesis according to any one of claims 1 to 3.

5. The wireless transmission includes a near field communication (NFC) transmission.

5. The inflatable penile prosthesis of claim 4.

6. The wireless transmission includes capacitive transmission or inductive transmission.

5. The inflatable penile prosthesis of claim 4.

7. The wireless transmission includes a radio frequency (RF) transmission.

5. The inflatable penile prosthesis of claim 4.

8. the printed circuit board assembly includes a magnetic sensing circuit, and the controller is configured to detect operation of the expansion cycle in response to the magnetic sensing circuit detecting the presence of a magnetic field.

2. The inflatable penile prosthesis of claim 1.

9. the electronic pump assembly includes an antenna, the antenna configured to receive the external signal, the external signal including a radio frequency (RF) signal; 2. The inflatable penile prosthesis of claim 1.

10. the electronic pump assembly includes an inductive antenna, the inductive antenna configured to receive the external signal, the external signal including an inductive signal; 2. The inflatable penile prosthesis of claim 1.

11. the electronic pump assembly includes an antenna, the antenna configured to receive the external signal, the external signal including an ultrasonic signal; 2. The inflatable penile prosthesis of claim 1.

12. the electronic pump assembly includes a pressure sensor, the controller configured to receive pressure measurements from the pressure sensor indicative of a pressure in the inflatable member, and the controller configured to determine that the inflation cycle has been activated in response to the pressure exceeding a threshold level.

2. The inflatable penile prosthesis of claim 1.

13. the electronic pump assembly includes a first conductive plate, and the controller is configured to determine actuation of the expansion cycle in response to a second conductive plate of an external device being positioned within a threshold distance of the first conductive plate.

2. The inflatable penile prosthesis of claim 1.

14. 1. A method of controlling an inflatable penile prosthesis, comprising: a controller of an electronic pump assembly detecting an external signal, said controller including a printed circuit board assembly, said printed circuit board assembly including a microprocessor or a state machine; determining, based on the external signal, to activate an inflation cycle of the inflatable penile prosthesis; activating at least one of a pump or an active valve to transfer fluid from a fluid reservoir to an inflatable member; The method includes:

15. and charging a battery of the electronic pump assembly based on the wireless transmission received via an antenna of the electronic pump assembly. The method of claim 14.

16. 1. An inflatable penile prosthesis comprising: a fluid reservoir configured to hold a fluid; An inflatable member; an electronic pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member; the electronic pump assembly comprising: A pump, An active valve; a controller configured to receive an external signal to operate an expansion cycle and to control at least one of the pump or the active valve to transfer the fluid to the inflatable member; the controller includes a printed circuit board assembly, the printed circuit board assembly including a microprocessor or a state machine. Inflatable penile prosthesis.

17. the electronic pump assembly includes an antenna, the antenna configured to receive the external signal, the external signal including a Bluetooth signal; 17. The inflatable penile prosthesis of claim 16.

18. the electronic pump assembly includes an antenna, the antenna configured to receive the external signal, the external signal including a near field communication (NFC) signal; 17. The inflatable penile prosthesis of claim 16.

19. the printed circuit board assembly includes a power source, the power source configured to be charged by the NFC signal.

19. The inflatable penile prosthesis of claim 18.

20. the printed circuit board assembly includes a magnetic sensing circuit, and the controller is configured to detect operation of the expansion cycle in response to the magnetic sensing circuit detecting the presence of a magnetic field.

17. The inflatable penile prosthesis of claim 16.

21. the electronic pump assembly includes an antenna, the antenna configured to receive the external signal, the external signal including a radio frequency (RF) signal; 17. The inflatable penile prosthesis of claim 16.

22. the electronic pump assembly includes an inductive antenna, the inductive antenna configured to receive the external signal, the external signal including an inductive signal; 17. The inflatable penile prosthesis of claim 16.

23. the electronic pump assembly includes an antenna, the antenna configured to receive the external signal, the external signal including an ultrasonic signal; 17. The inflatable penile prosthesis of claim 16.

24. the electronic pump assembly includes a pressure sensor, the controller configured to receive pressure measurements from the pressure sensor indicative of a pressure in the inflatable member, and the controller configured to determine that the inflation cycle has been activated in response to the pressure exceeding a threshold level.

17. The inflatable penile prosthesis of claim 16.

25. the electronic pump assembly includes a first conductive plate, and the controller is configured to determine actuation of the expansion cycle in response to a second conductive plate of an external device being positioned within a threshold distance of the first conductive plate.

17. The inflatable penile prosthesis of claim 16.

26. the electronic pump assembly includes an acoustic sensor configured to receive an acoustic signal, and the controller is configured to determine actuation of the expansion cycle in response to the acoustic signal.

17. The inflatable penile prosthesis of claim 16.

27. 1. An inflatable penile prosthesis comprising: a fluid reservoir configured to hold a fluid; An inflatable member; an electronic pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member; the electronic pump assembly comprising: A pump, An active valve; an antenna configured to receive an external signal; a controller configured to determine to activate an expansion cycle based on the external signal and to control at least one of the pump or the active valve to transfer the fluid to the inflatable member; a power source configured to provide power to the controller and configured to be charged by wireless transmissions received via the antenna; Including, Inflatable penile prosthesis.

28. The wireless transmission includes a near field communication (NFC) transmission.

28. The inflatable penile prosthesis of claim 27.

29. The wireless transmission includes a radio frequency (RF) transmission.

28. The inflatable penile prosthesis of claim 27.

30. The wireless transmission includes capacitive transmission or inductive transmission.

28. The inflatable penile prosthesis of claim 27.

31. the controller includes a printed circuit board assembly, the printed circuit board assembly including a microprocessor configured to interpret the external signal; 28. The inflatable penile prosthesis of claim 27.

32. the controller includes a printed circuit board assembly, the printed circuit board assembly including a state machine configured to interpret the external signal; 28. The inflatable penile prosthesis of claim 27.

33. the state machine comprises a field programmable gate array or an application specific integrated circuit; 33. The inflatable penile prosthesis of claim 32.

34. 1. A method of controlling an inflatable penile prosthesis, comprising: a controller of an electronic pump assembly detecting an external signal, said controller including a printed circuit board assembly, said printed circuit board assembly including a microprocessor or a state machine; determining, based on the external signal, to activate an inflation cycle of the inflatable penile prosthesis; activating at least one of a pump or an active valve to transfer fluid from a fluid reservoir to an inflatable member; The method includes:

35. charging a battery of the electronic pump assembly based on wireless transmissions received via an antenna of the electronic pump assembly, the wireless transmissions including inductive transmissions, ultrasonic transmissions, near field communication (NFC) transmissions, radio frequency (RF) transmissions, or capacitive transmissions.

35. The method of claim 34.

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