Electronic pump assembly for an implantable device having an active valve - Patents.com

Abstract

According to an embodiment, an active valve (118) for an implantable device includes a base plate (148) defining an opening (151), a piezoelectric element (140), a diaphragm actuator (146) coupled to the piezoelectric element, and a protrusion (142) coupled to the diaphragm actuator. In response to the piezoelectric element being actuated, the diaphragm actuator is configured to move the protrusion in a first direction into the opening until the protrusion contacts a portion of the base plate.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of and claims priority to U.S. Nonprovisional Patent Application No. 18 / 182,607, entitled “AN ELECTRONIC PUMP ASSEMBLY FOR AN IMPLANTABLE DEVICE HAVING AN ACTIVE VALVE,” filed March 13, 2023, which claims priority to U.S. Provisional Patent Application No. 63 / 269,447, entitled “AN ELECTRONIC PUMP ASSEMBLY FOR AN IMPLANTABLE DEVICE HAVING AN ACTIVE VALVE,” filed March 16, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 269,447, filed March 16, 2022, the disclosure of which is incorporated by reference in its entirety herein.

[0003] This disclosure relates generally to bodily implants, and more particularly to bodily implants such as electronic implantable devices having active valves. [Background technology]

[0004] Implantable devices may include valves to allow or block fluid flow between components of the implantable device, in some cases, conventional valves may not provide sufficient clearance to allow a desired flow rate while minimizing leakage through the valve. Summary of the Invention [Means for solving the problem]

[0005] According to an aspect, an active valve for an implantable device includes a base plate defining an opening, a piezoelectric element, a diaphragm actuator coupled to the piezoelectric element, and a protrusion coupled to the diaphragm actuator configured to move the protrusion in a first direction into the opening until the protrusion contacts a portion of the base plate in response to the piezoelectric element being actuated.

[0006] The active valve may include one or more of the following features (or any combination thereof): The protrusion includes a tapered conical portion. The protrusion includes a metal-based material. The opening includes a tapered conical hole. The diaphragm actuator includes a metal-based material. The diaphragm actuator is coupled to the base plate. The diaphragm actuator includes a first side and a second side, the piezoelectric element is coupled to the first side of the diaphragm actuator, and the protrusion is coupled to the second side of the diaphragm actuator. The diaphragm actuator includes a metal-based material. At least a portion of the protrusion is disposed outside the opening in the base plate in response to the piezoelectric element not being actuated.

[0007] According to an aspect, an implantable device includes a fluid reservoir configured to hold a fluid, an expandable member, and an electronic pump assembly including a controller and an active valve. The active valve includes a base plate defining an opening, a piezoelectric element, a diaphragm actuator coupled to the piezoelectric element, and a protrusion coupled to the diaphragm actuator. The controller is configured to activate the piezoelectric element to move the protrusion in a first direction into the opening until the protrusion contacts a portion of the base plate. The controller is configured to deactivate the piezoelectric element to move at least a portion of the protrusion out of the opening. The protrusion includes a metal needle portion. The metal needle portion includes a tapered cone portion. The base plate includes a metal-based material, and the opening on the base plate includes a tapered cone hole configured to receive the tapered cone portion. The diaphragm actuator is welded to the base plate. The piezoelectric element is bonded to the diaphragm actuator with an epoxy-based material. The opening is an inlet port configured to receive the fluid, and the base plate defines an outlet port for expelling the fluid. The inlet port is coupled to the expandable member and the outlet port is coupled to the fluid reservoir.

[0008] According to an embodiment, a method of actuating an active valve of an implantable device includes receiving a first control signal to apply a voltage to a piezoelectric element of an active valve of the implantable device, the active valve including a base plate defining an opening, a diaphragm actuator coupled to the piezoelectric element, and a protrusion coupled to the diaphragm actuator, and in response to actuation of the piezoelectric element, moving the protrusion in a first direction into the opening of the base plate until the protrusion contacts a portion of the base plate. In some examples, the method includes receiving a second control signal to de-energize the piezoelectric element of the active valve, and in response to the second control signal, moving the protrusion in a second direction such that at least a portion of the protrusion is disposed outside the opening of the base plate. In some examples, the method includes forming a metal-to-metal seal with the protrusion and the base plate. [Brief description of the drawings]

[0009] [Figure 1A]1 illustrates an implantable device having an active valve according to an embodiment. [Figure 1B] FIG. 1 illustrates an example of an active valve, according to an aspect. [Figure 2A] 1A-1C illustrate examples of diaphragm actuators and protrusions of an active valve according to an embodiment. [Figure 2B] 13A-13C illustrate examples of base plates and diaphragm actuators according to an embodiment. [Figure 2C] 13A-13C illustrate examples of diaphragm actuators coupled to a base plate according to an embodiment. [Figure 2D] 1A-1C illustrate examples of piezoelectric elements coupled to a diaphragm actuator according to an embodiment. [Figure 2E] 1 illustrates an example of an active valve in an open position according to an aspect. [Diagram 3] 1 is a flow chart illustrating an example operation of an active valve according to an aspect. [Figure 4] 1 is a flow chart illustrating an example operation of manufacturing an active valve according to an aspect. [Diagram 5] FIG. 1 illustrates an example of an inflatable penile prosthesis according to an embodiment. [Figure 6] FIG. 1 illustrates an example of an artificial urinary sphincter device, according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The present disclosure relates to active valves that can improve the performance of implantable devices. For example, the active valves discussed herein can achieve a relatively consistent (over a period of time) flow rate while minimizing leakage through the active valve. The active valve can include a piezoelectric diaphragm valve. The active valve is configured to transition from an open position (fluid is permitted to pass through the active valve) to a closed position (fluid is prevented from being transferred through the active valve). In some examples, in the closed position, the active valve provides a metal-to-metal seal to prevent fluid transfer through the active valve. In some examples, the metal-to-metal seal can provide consistent performance (e.g., given that metal machining can provide tighter tolerances when compared to the higher tolerances required by rubber-based materials). In some examples, the active valve does not include a rubber-based material (e.g., a rubber-based ring member or O-ring) to provide a seal, which can minimize the risk of adding particles to the fluid (e.g., saline) (e.g., most rubber-based materials are likely to wear during operation).

[0011] The active valve may include a diaphragm actuator coupled to a protrusion. The diaphragm actuator may include a metal-based material. In some examples, the diaphragm actuator may be a thin flexible piece (e.g., a circular / cylindrical piece) of a metal material (e.g., a foil). In some examples, the protrusion is a metal needle portion. In some examples, the metal needle portion includes a tapered cone portion. The protrusion may be welded to a face (e.g., a center portion) of the diaphragm actuator. The active valve includes a bottom plate that defines an inlet port and an outlet port. When the active valve is in an open position, fluid may be transferred from the inlet port to the outlet port. When the active valve is in a closed position, fluid may be prevented from being transferred from the inlet port to the outlet. The bottom plate may be a metal cylindrical portion. The inlet port is an opening (e.g., a tapered cone hole) configured to receive the protrusion (to block the flow). For example, the bottom plate is coupled (e.g., welded) to the diaphragm actuator such that the protrusion is aligned with the opening. The active valve includes a piezoelectric element coupled (e.g., through an epoxy material) to a diaphragm actuator. In some examples, the piezoelectric element is a structure configured to change shape of the element when a voltage is applied.

[0012] In response to the piezoelectric element being activated (e.g., a voltage is applied to the piezoelectric element), the diaphragm actuator moves toward the base plate such that the protrusion moves in a first direction into an opening in the base plate until the protrusion contacts a portion of the base plate (within the opening) thereby providing a metal-to-metal seal. In response to the piezoelectric element being deactivated (e.g., the voltage is removed from the piezoelectric element), the diaphragm actuator moves away from the base plate such that at least a portion of the protrusion is disposed outside the opening, thereby allowing fluid to flow through the active valve.

[0013] In some examples, the implantable device is an artificial urinary sphincter device. In some examples, the implantable device is an inflatable penile prosthesis. The implantable device can include an inflatable member, an electronic pump assembly, and a fluid reservoir. The electronic pump assembly can transfer fluid between the fluid reservoir and the inflatable member without a user manually activating the pump bulb. For example, the transfer of fluid between the inflatable member and the fluid reservoir is electrically controlled.

[0014] The electronic pump assembly may include a controller, one or more active valves, one or more pumps, and one or more pressure sensors. The electronic pump assembly may include a circuit board, a battery, and a communication module for controlling the inflatable member. The controller (e.g., processor, driver) may control (e.g., activate, activate, deactivate, move, etc.) the pump and the active valve to move fluid between the inflatable member and a fluid reservoir to transition the inflatable member between an inflated state and a deflated state. In some examples, the pump is activated to transfer fluid to the inflatable member, and the active valve is disposed in a fluid passage used to empty the inflatable member. In some examples, the controller may move the active valve to an open position to deflate the inflatable member. In some examples, the active valve is transitioned to an open position to transfer fluid from the fluid reservoir to the inflatable member during an inflation cycle, and the pump is activated to transfer fluid from the inflatable member to the fluid reservoir during a deflation cycle.

[0015] 1A illustrates an implantable device 100 according to an embodiment. The implantable device 100 can include a fluid reservoir 102, an expandable member 104, and an electronic pump assembly 106 configured to transfer fluid between the fluid reservoir 102 and the expandable member 104. In some examples, the implantable device 100 is an artificial urinary sphincter device. In some examples, the implantable device 100 is an inflatable penile prosthesis. However, the implantable device 100 can include any type of medical device that transfers fluid between its components.

[0016] 1B illustrates an example of an active valve 118. One or more active valves 118 may be included within the electronic pump assembly 106. The active valve 118 may be an electronically controlled valve. The active valve 118 may be electronically controlled by the controller 114 of the electronic pump assembly 106. The active valve 118 may achieve a desired flow rate (over a period of time) while minimizing leakage therethrough. In some examples, the active valve 118 includes a piezoelectric diaphragm valve. The active valve 118 is configured to transition from an open position (fluid is permitted to pass through the active valve 118) to a closed position (fluid is prevented from being transferred through the active valve 118).

[0017] In some examples, in the closed position, the active valve 118 provides a metal-to-metal seal to prevent the transfer of fluid therethrough. In some examples, the metal-to-metal seal can provide consistent performance (e.g., given that metal machining can provide tighter tolerances when compared to the higher tolerances required by rubber-based materials). In some examples, the active valve 118 does not include a rubber-based material (e.g., a rubber-based ring member or O-ring) to provide a seal, thereby minimizing the risk of adding particles to the fluid (e.g., saline) (e.g., most rubber-based materials are likely to wear down during operation).

[0018] 1A, the electronic pump assembly 106 can include a single active valve 118. In some examples, the electronic pump assembly 106 includes multiple active valves 118. In some examples, one or more additional active valves 118 can be in series with the pump 120-1 and / or the pump 120-2. In some examples, the additional active valves 118 (e.g., the series active valve 118) can be disposed in the fluid path portion 117 connected to the fluid reservoir 102. In some examples, the additional active valves 118 (e.g., the series active valve 118) can be disposed in the fluid path portion 119 connected to the expandable member 104. These additional active valves 118 can reduce leakage when at maximum inflation pressure or partial inflation pressure.

[0019] 1A, the active valve 118 can be connected to the controller 114 of the electronic pump assembly 106 and can receive a signal to transition the active valve 118 between an open position and a closed position. In some examples, the active valve 118 is disposed in a fluid passage 124 used to empty the expandable member 104 (e.g., in a deflation cycle). In some examples, the active valve 118 is disposed in a fluid passage 124 used to fill the expandable member 104 (e.g., in an inflation cycle). In some examples, the active valve 118 can be transitioned to a closed position to hold (e.g., substantially hold) pressure in the expandable member 104. In some examples, the active valve 118 can be transitioned to an open position to transfer fluid back to the fluid reservoir 102, to release pressure in the expandable member 104, and / or to allow backflow to the expandable member 104. In some examples, the active valve 118 can be used to hold (e.g., substantially hold) a partial inflation pressure.

[0020] 1B, the active valve 118 can include a diaphragm actuator 146 coupled to the protrusion 142. The diaphragm actuator 146 can include a metal-based material. In some examples, the diaphragm actuator 146 can be a thin flexible piece (e.g., a circular / cylindrical piece) of a metal material (e.g., a foil). In some examples, the protrusion 142 includes a metal-based material. In some examples, the protrusion 142 includes a metal needle portion. In some examples, the protrusion 142 includes a tapered cone portion. The protrusion 142 can be coupled to a portion of the diaphragm actuator 146. In some examples, the protrusion 142 is welded to a face (e.g., a center portion) of the diaphragm actuator 146. The active valve 118 includes a base plate 148 that defines an inlet port 152 and an outlet port 150. When the active valve 118 is in an open position, fluid can be transferred from the inlet port 152 to the outlet port 150.

[0021] When the active valve 118 is in a closed position, fluid can be prevented from being transferred from the inlet port 152 to the outlet port 150. The bottom plate 148 can be a metal cylindrical section. The inlet port 152 is an opening 151 (e.g., a tapered conical hole) configured to receive the protrusion 142 when the active valve 118 is in a closed position. The bottom plate 148 is coupled (e.g., welded) to the diaphragm actuator 146 such that the protrusion 142 is aligned with the opening 151 (or the inlet port 152). The active valve 118 includes a piezoelectric element 140 coupled to the diaphragm actuator 146 through an epoxy material 144. In some examples, the piezoelectric element 140 is configured to move (e.g., bend) when a voltage is applied thereto.

[0022] In response to the piezoelectric element 140 being activated (e.g., a voltage is applied to the piezoelectric element 140), movement of the piezoelectric element 140 causes the diaphragm actuator 146, which moves in a first direction A1 toward the base plate 148 and into an opening 151 in the base plate 148 until the protrusion 142 contacts a portion 141 (defining an opening 151) of the base plate 148, thereby providing a metal-to-metal seal. As shown in FIG. 1B, in response to the piezoelectric element 140 being deactivated (e.g., the voltage is removed from the piezoelectric element 140), the diaphragm actuator 146 moves (e.g., bends away) in a direction A2 away from the base plate 148 such that at least a portion of the protrusion 142 is positioned outside of the opening 151, thereby allowing fluid to flow through the active valve 118.

[0023] Returning to reference to FIG. 1A, in some examples, the inflatable member 104 is an inflatable cuff member configured to be implemented around the patient's urethra. In some examples, the inflatable member 104 is a penile inflatable member (e.g., one or more inflatable cylinders) that can be implanted within the user's corpus cavernosum. In some examples, the fluid reservoir 102 can be implanted within the user's abdominal or pelvic cavity (e.g., the fluid reservoir 102 can be implanted in a lower portion of the user's abdominal cavity or an upper portion of the user's pelvic cavity). In some examples, at least a portion of the electronic pump assembly 106 can be implemented within the patient's body.

[0024] The fluid reservoir 102 may include a container having an internal chamber configured to hold or contain a fluid used to inflate the expandable member 104. The volumetric capacity of the fluid reservoir 102 may vary depending on the size of the implantable device 100. In some examples, the volumetric capacity of the fluid reservoir 102 may be between 3 cubic centimeters and 150 cubic centimeters. In some examples, the fluid reservoir 102 is composed of the same material as the expandable member 104. In other examples, the fluid reservoir 102 is composed of a different material than the expandable member 104. In some examples, the fluid reservoir 102 contains a larger volume of fluid than the expandable member 104.

[0025] The implantable device 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 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 therethrough between the electronic pump assembly 106 and the fluid reservoir 102. 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 tubing members for transferring fluid between the electronic pump assembly 106 and the fluid reservoir 102.

[0026] The second conduit connector 105 can be coupled to the pump assembly 106 and the expandable member 104 such that fluid can be transferred therethrough between the electronic pump assembly 106 and the expandable member 104. For example, the second conduit connector 105 can define a second lumen configured to transfer fluid between the electronic pump assembly 106 and the expandable member 104. The second conduit connector 105 can include a single or multiple tubing members for transferring fluid between the electronic pump assembly 106 and the expandable 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.

[0027] The electronic pump assembly 106 can automatically transfer fluid between the fluid reservoir 102 and the expandable member 104 without a user having to manually activate the pump (e.g., squashing and releasing a pump bulb). The electronic pump assembly 106 can monitor, control, and regulate the pressure within the expandable member 104. The electronic pump assembly 106 can include a controller 114, one or more active valves 118, one or more pumps 120, and a pressure sensor 130 (or multiple pressure sensors). The controller 114 can control the pumps 120 and the active valves 118 to move fluid between the expandable member 104 and the fluid reservoir 102 to transition the expandable member 104 between an inflated state and a deflated state. The pressure sensor 130 can monitor the pressure in the expandable member 104. The controller 114 can receive pressure readings from the pressure sensor 130 and control the pump 120 and the active valve 118 to maintain and / or adjust the pressure in the expandable member 104. The controller 114 can send control signals to the pump 120 and the active valve 118 to inflate or deflate the expandable member 104. In some examples, control of the inflation and deflation states is based on a wireless signal 109 received from an external device 101 actuated by the patient (and the detected pressure of the expandable member 104 from the pressure sensor 130). For example, the patient can use the external device 101 to inflate or deflate the expandable member 104, whereupon the external device 101 sends the wireless signal 109 to the controller 114.

[0028] The electronic pump assembly 106 can include a battery 116 configured to provide power to the controller 114 and other components thereon. In some examples, the battery 116 is a non-rechargeable battery. In some examples, the battery 116 is a rechargeable battery. In some examples, the electronic pump assembly 106 (or a portion thereof) (or the controller 114) is configured to be connected to an external charger to charge the battery 116. In some examples, the electronic pump assembly 106 can define a charging interface configured to connect to the external charger. In some examples, the charging interface includes a Universal Serial Bus (USB) interface configured to accept a USB charger. In some examples, the charging technology can be electromagnetic or piezoelectric.

[0029] The electronic pump assembly 106 can include an antenna 112 configured to wirelessly transmit (and receive) a wireless signal 109 to (and from) the external device 101. 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 smartphone, a tablet, a pendant, a key fob, etc. A user can control the implantable device 100 with the external device 101. In some examples, the user can inflate or deflate the expandable member 104 with the external device 101. For example, in response to a user initiating an inflation cycle with the external device 101 (e.g., selecting a user controller on the external device 101), the external device 101 can transmit a wireless signal 109 to the electronic pump assembly 106 (received through the antenna 112) to initiate an inflation cycle, and the controller 114 can control the active valve 118 and the pump 120 to inflate the expandable member 104 to a target inflation pressure. In some examples, the controller 114 can place the active valve 118 in a closed position and activate the pump to move fluid from the fluid reservoir 102 to the expandable member 104 .

[0030] In some examples, in response to a user initiating a deflation cycle with the external device 101 (e.g., selecting a user controller on the external device 101), the external device 101 can transmit a wireless signal 109 to the electronic pump assembly 106 (received through the antenna 112) to initiate a deflation cycle, and the controller 114 can control the active valve 118 (and in some examples the pump 120) to transfer fluid from the expandable 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 expandable member 104 to the fluid reservoir 102. In some examples, the controller 114 can control one or more pumps 120 to further transfer fluid from the expandable member 104 to the fluid reservoir 102 during a deflation cycle. In some examples, during a deflation cycle, fluid is transferred back until the pressure in the expandable member 104 reaches a partial inflation pressure. In some examples, the controller 114 can automatically decide to initiate a contraction cycle, which causes the controller 114 to control the active valve 118 (and in some examples the pump 120) to transfer fluid back to the fluid reservoir 102.

[0031] The controller 114 can be any type of controller configured to control the operation of the pump 120 and the active valve 118. In some examples, the controller 114 is a microcontroller. In some examples, the controller 114 includes one or more drivers configured to drive the pump 120 and the active valve 118. In some examples, the drivers are separate components from the controller 114. The controller 114 can be communicatively coupled to the active valve 118, the pump 120, and the pressure sensor 130. In some examples, the controller 114 is connected to the active valve 118, the pump 120, and the pressure sensor 130 through wired data lines. The controller 114 can include a processor 113 and a memory device 115.

[0032] The processor 113 may be formed in a substrate configured to execute one or more machine executable instructions or some software, firmware, or a combination thereof. The processor 113 may be semiconductor based, i.e., the processor may include semiconductor materials capable of executing digital logic. The memory device 115 may store information in a format that may be read and / or executed by the processor 113. The memory device 115 may store executable instructions that, when executed by the processor 113, cause the processor 113 to perform certain operations discussed herein. The controller 114 may receive data through the pressure sensor 130 and / or the external device 101 and control the active valve 118 and / or the pump 120 by sending control signals to the active valve 118 and / or the pump 120.

[0033] The memory device 115 can store control parameters that a user and / or physician can set or modify by using the external device 101. In some examples, the control parameters can include a target inflation pressure and / or a partial inflation pressure. In some examples, the target inflation pressure is the highest (or desired) pressure allowable in the expandable member 104. In some examples, the partial inflation pressure is a pressure threshold that can more closely mimic a user's natural experience and / or personal comfort. The user or physician can update the control parameters using the external device 101, which can be communicated to the controller 114 through the antenna 112 and updated in the memory device 115.

[0034] The external device 101 can communicate with the electronic pump assembly 106 over a network. In some examples, the network can include a short-range wireless network, such as near field communication (NFC), Bluetooth, or infrared communication. In some examples, the network can include the Internet (e.g., Wi-Fi) and / or other types of data networks, such as a local area network (LAN), a wide area network (WAN), a cellular network, a satellite network, or other types of data networks.

[0035] 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 includes 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 expandable member 104 (e.g., during an expansion cycle). In some examples, the pump 120-2 is arranged in a fluid passage 127 used to fill the expandable 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.

[0036] In some examples, pump 120 can include more than two pumps 120, such as three, four, five, six, or more than six pumps 120. For example, pump 120 can further include a third pump in parallel with pump 120-2, a fourth pump in parallel with the third pump, and the like. In some examples, 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 can be in series with pump 120-2.

[0037] Each pump 120 is an electronically controlled pump. Each pump 120 can be electronically controlled by the controller 114. For example, each pump 120 can be connected to the controller 114 and can receive a signal to operate the respective pump 120. The pumps 120 can be one-way pumps 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 pumps 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 can be either one-way or bidirectional pumps. In some examples, the pumps 120 include a combination of one or more one-way pumps and one or more bidirectional pumps.

[0038] In some examples, the pump 120 is an electromagnetic pump that uses electromagnetism to move fluid between the fluid reservoir 102 and the expandable member 104. With an electromagnetic pump, a magnetic field is set at an angle to the direction the fluid is moving and an electric current is applied.

[0039] 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 a fluid. In some examples, the piezoelectric pump can include one or more piezoelectric pumps (e.g., piezoelectric elements) that can be implemented with a substrate layer of high voltage piezoelectric elements (e.g., a single substrate layer) or with 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 a non-mechanical (e.g., no moving parts) pump.

[0040] 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 can include 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 (where the second number is different from the first number). Pump 120-1 can be an electromagnetic pump and pump 120-2 can be a piezoelectric pump.

[0041] The pump 120 may include one or more passive check valves. The passive check valves may assist in maintaining pressure within the expandable 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 or more than two passive check valves. The passive check valves of each pump 120 may not be directly controlled by the controller 114 and may be based on the pressure between the expandable member 104 and the fluid reservoir 102. The passive check valves may transition between an open position (fluid is allowed to flow through the passive check valve) and a closed position (fluid is prevented from flowing through the passive check valve). In some examples, the passive check valves transition to a closed position in response to a positive pressure between the expandable member 104 and the fluid reservoir 102. In some examples, the passive check valve transitions to an open position in response to negative pressure between the expandable member 104 and the fluid reservoir 102 .

[0042] In some examples, the use of two parallel pumps (e.g., pump 120-1, pump 120-2) (or more than two parallel pumps 120) can increase the amount of fluid that can be transferred to the inflatable member 104. In some examples, the pumps 120 can be operated out of phase with each other to increase the efficiency of the electronic pump assembly 106. Two parallel pumps (e.g., pump 120-1, pump 120-2) operating out of phase with each other (e.g., 180 degrees out of phase) can allow the output pressure of pump 120-1 to improve valve closure of pump 120-2, thereby improving overall performance (and vice versa). The use of parallel pumps 120 operating out of phase with each other can allow the pumps 120 to operate at a lower frequency, thereby reducing power (thus extending battery life). Additionally, a smoother flow rate can be achieved resulting in less vibration and improved patient experience. As indicated above, one or more pumps 120 can be in series with one or more parallel pumps 120. For example, an additional pump 120 can be in series with pump 120-1 and / or an additional pump 120 can be in series with pump 120-2. Series pumps can allow for pressure doubling when two similarly functioning pumps 120 are utilized. In some examples, two or more series-arranged pumps 120 can be operated in phase.

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

[0044] 2A-2E illustrate an active valve 218 according to an embodiment. As shown in FIG. 2A, the active valve 218 includes a diaphragm actuator 246 coupled to the protrusion 242. The diaphragm actuator 246 can include a metal-based material. In some examples, the diaphragm actuator 246 can be a thin, flexible piece of metal material (e.g., foil). In some examples, the diaphragm actuator 246 includes a cylindrical portion. The diaphragm actuator 246 includes a first face 260 and a second face 262 (shown in FIG. 2B), and the distance between the first face 260 and the second face 262 defines a thickness of the diaphragm actuator 246. A sidewall 264 extends between the first face 260 and the second face 262. The first face 260 can have a disc shape. The second face 262 can have a disc shape.

[0045] The protrusion 242 can include a metal-based material. In some examples, the protrusion 242 is a needle portion (e.g., a metal needle portion). In some examples, the protrusion 242 includes a cone portion. In some examples, the protrusion 242 includes a tapered cone portion. The protrusion 242 includes a first end portion 261 and a second end portion 263. The first end portion 261 can have a size (e.g., diameter) that is smaller than the size (e.g., diameter) of the second end portion 263.

[0046] The protrusion 242 is coupled to the diaphragm actuator 246. In some examples, the protrusion 142 is coupled to the diaphragm actuator 246 through a welded portion 254 (e.g., the protrusion 142 is welded to the diaphragm actuator 246). An end portion 263 of the protrusion 242 can be coupled to a first surface 260 of the diaphragm actuator 246. In some examples, a second end portion 263 of the protrusion 242 is coupled to a central portion of the first surface 260 of the diaphragm actuator 246.

[0047] 2B, the active valve 218 includes a bottom plate 248. The bottom plate 248 can include a metal-based material. In some examples, the bottom plate 248 includes a cylindrical portion (e.g., a metal cylindrical portion). The bottom plate 248 can include a first surface 271 and a second surface 273, and the distance between the first surface 271 and the second surface 273 defines a thickness of the bottom plate 248. The bottom plate 248 includes a sidewall 275 that extends between the first surface 271 and the second surface 273. In some examples, the bottom plate 248 can have a diameter that is the same (or substantially the same (e.g., within 1 or 2 millimeters)) as a diameter of the diaphragm actuator 246.

[0048] The base plate 248 can define an inlet port 252 and an outlet port 250. When the active valve 218 is in an open position (as shown in FIG. 2E), fluid can be transferred from the inlet port 252 to the outlet port 250 through a chamber 299 (as shown in FIG. 2E). When the active valve 218 is in a closed position, fluid can be prevented from transferring from the inlet port 152 to the outlet port 150 (e.g., prevented by the protrusion 242). The inlet port 252 is an opening 251 (e.g., a hole) that extends through the thickness of the base plate 248. In some examples, the thickness of the base plate 248 is greater than the length of the protrusion 242, which can be the distance between the first end portion 261 and the second end portion 263. The outlet port 250 is an opening (e.g., a hole) that extends through the thickness of the base plate 248. In some examples, the outlet port 250 has a shape that is different from the shape of the inlet port 252. In some instances, the exit port 250 is not tapered.

[0049] In some examples, the opening 251 includes a tapered cylindrical portion 270 configured to receive the protrusion 242 when the active valve 218 is in the closed position. In some examples, the protrusion 242 (e.g., the length of the protrusion 242) is disposed in the tapered cylindrical portion 270 when the active valve 218 is in the closed position. In some examples, the opening 251 includes a non-tapered cylindrical portion 272. In some examples, the protrusion 242 is not disposed in the non-tapered cylindrical portion 272 when the active valve 218 is in the closed position.

[0050] As shown in Figure 2C, the base plate 248 is coupled (e.g., welded) to the diaphragm actuator 246 such that the protrusion 242 is aligned with the opening 251 (or inlet port 252). In some examples, a weld ring 154 is formed on a second surface 262 of the diaphragm actuator 246. As shown in Figure 2D, the active valve 218 includes a piezoelectric element 240 coupled to the second surface 262 of the diaphragm actuator 246 through an epoxy material 256.

[0051] 2E illustrates the active valve 218 in an open position. In response to the piezoelectric element 240 being activated (e.g., a voltage is applied to the piezoelectric element 240), the diaphragm actuator 246 moves (e.g., bends) toward the base plate 248 such that the protrusion 242 moves in a first direction A1 into an opening 251 in the base plate 248 until the protrusion 242 contacts a portion 241 (defining the opening 151) of the base plate 148, thereby providing a metal-to-metal seal. As shown in FIG. 2E, in response to the piezoelectric element 240 being deactivated (e.g., the voltage is removed from the piezoelectric element 240), the diaphragm actuator 246 moves (e.g., bends) in a second direction A2 away from the base plate 248 such that at least a portion of the protrusion 242 is positioned outside the opening 251, thereby allowing fluid to flow through the active valve 218.

[0052] Figure 3 illustrates a flow chart 300 depicting an example operation of a method for operating an active valve of an electronic pump assembly of an inflatable member. Although the operation of Figure 3 is described with respect to active valve 118 of Figures 1A and 1B, the example operation of flow chart 300 may be performed by any of the active valve and / or electronic pump assemblies discussed herein.

[0053] Actuation 302 includes receiving a first control signal to apply a voltage to a piezoelectric element 140 of an active valve 118 of implantable device 100, the active valve 118 including a base plate 148 defining an opening 150, a diaphragm actuator 146 coupled to the piezoelectric element 140, and a protrusion 142 coupled to the diaphragm actuator 146. Actuation 304 includes, in response to actuation of the piezoelectric element 140, moving the protrusion 142 in a first direction A1 into the opening 151 of the base plate 148 until the protrusion 142 contacts a portion 141 of the base plate 148.

[0054] Figure 4 illustrates a flow chart 400 depicting example operations of a method for manufacturing an active valve of an electronic pump assembly of an inflatable member. Although the operations of Figure 4 are described with respect to active valve 218 of Figures 2A and 2E, the example operations of flow chart 400 may be performed by any of the active valves and / or electronic pump assemblies discussed herein.

[0055] Actuation 402 includes coupling the protrusion 242 to the diaphragm actuator 246. As shown in FIG. 2A, the protrusion 242 is coupled to the diaphragm actuator 246 by welding (e.g., welded joint). Actuation 404 includes coupling the diaphragm actuator 246 to the bottom plate 248 such that the protrusion 242 is aligned with the opening 251 on the bottom plate 248. As shown in FIGS. 2B and 2C, the diaphragm actuator 246 is moved toward and contacts the bottom plate 248 with the protrusion 242 aligned with the opening 251 and is coupled (by welding) to the bottom plate. Actuation 406 includes coupling the piezoelectric element 240 to the diaphragm actuator 246. As shown in FIG. 2D, the piezoelectric element 240 is coupled to the diaphragm actuator 246 using an epoxy material 256.

[0056] FIG. 5 illustrates in a schematic manner an inflatable penile prosthesis 500 having an electronic pump assembly 506 according to an embodiment. The electronic pump assembly 506 may include any of the features of the electronic pump assemblies discussed herein, including the active valve 118 of FIG. 1A and FIG. 1B and the active valve 218 of FIG. 2A-FIG. 2E. The inflatable penile prosthesis 500 may include an inflatable member 504 (e.g., a pair of inflatable cylinders 510) configured to be implanted within the penis. For example, one of the inflatable cylinders 510 may be disposed on one side of the penis and the other inflatable cylinder 510 may be disposed on the other side of the penis. Each inflatable cylinder 510 may include a first end portion 524, a cavity or expansion chamber 522, and a second end portion 528 having a rear tip 532.

[0057] At least a portion of the electronic pump assembly 506 can be implanted in the patient's body. A pair of conduit connectors 505 can attach the electronic pump assembly 506 to the inflatable cylinder 510 such that the electronic pump assembly 506 is in fluid communication with the inflatable cylinder 510. Similarly, the electronic pump assembly 506 can be in fluid communication with the fluid reservoir 502 through the conduit connector 503. The fluid reservoir 502 can be implanted in the abdomen of the user. The expansion chamber 522 of the inflatable cylinder 510 can be disposed in the penis. The first end portion 524 of the inflatable cylinder 510 can be disposed at least partially in the glans portion of the penis. The second end portion 528 can be implanted in the patient's pubic region PR with the rear tip 532 proximate the pubic bone PB.

[0058] To implant the expandable cylinder 510, the surgeon will first prepare the patient. Often, the surgeon will create an incision, for example, in the penoscrotal region where the base of the penis meets the top of the scrotum. The surgeon can expand the patient's corpus cavernosum from the penoscrotal incision to prepare the patient to receive the expandable cylinder 510. The corpus cavernosum is the one of two parallel columns of erectile tissue, e.g., two elongated columns that run substantially the entire length of the penis, that form the back of the body of the penis. The surgeon will also expand two areas of the pubic region to prepare the patient to receive the second end portion 528. The surgeon can measure the length of the corpus cavernosum from the incision and the length of the expanded region of the pubic region to determine the appropriate size of the expandable cylinder 510 to be implanted.

[0059] After the patient is prepared, the inflatable penile prosthesis 500 is implanted in the patient's body. The tip of the first end portion 524 of each inflatable cylinder 510 can be connected to a suture. The other end of the suture can be connected to a needle member (e.g., a Keith needle). The needle member is inserted into the incision and into the expanded corpus cavernosum. The needle member is then pushed through the glans of the penis. The surgeon pulls the suture to retract the inflatable cylinder 510 into the corpus cavernosum. This retraction is performed for each inflatable cylinder 510 that constitutes a pair. Once the expansion 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 rear end of the inflatable cylinder 510 into the incision and pushes the second end portion 528 toward the pubic bone PB until each inflatable cylinder 510 is in place.

[0060] A user can control the inflatable penile prosthesis 500 using the external device 501. In some examples, the user can inflate or deflate the inflatable cylinder 510 using the external device 501. For example, in response to a user initiating an inflation cycle using the external device 501, the external device 501 can send a wireless signal to the electronic pump assembly 506 to initiate an inflation cycle and transfer fluid from the fluid reservoir 502 to the inflatable cylinder 510. In some examples, in response to a user initiating a deflation cycle using the external device 501, the external device 501 can send a wireless signal to the electronic pump assembly 506 to initiate a deflation cycle and transfer fluid from the inflatable cylinder 510 to the fluid reservoir 502. In some examples, during a deflation cycle, fluid is transferred back until the pressure in the inflatable cylinder 510 reaches a partial inflation pressure.

[0061] 6 illustrates a urethral control device 600 having an electronic pump assembly 606 according to an embodiment. The electronic pump assembly 606 may include any of the features of the electronic pump assemblies discussed herein, including the active valve 118 of Figures 1A and 1B and the active valve 218 of Figures 2A-2E. The urethral control device 600 includes a pump assembly 606, a fluid reservoir 602, and a cuff 604.

[0062] The fluid reservoir 602 may be a pressure-regulated inflation balloon or element. The fluid reservoir 602 is in operative fluid communication with the cuff 604 through one or more tubular members 603, 605. The fluid reservoir 602 is comprised of a polymeric material capable of elastic deformation to reduce the fluid volume therein and expel the fluid therefrom into the cuff 604. However, the material of the fluid reservoir 602 may preferably be or include a shape memory structure adapted to maintain the fluid reservoir 602 in a generally expanded state while having a relatively constant fluid volume and pressure. In some examples, this constant level of pressure exerted by the fluid reservoir 602 on the cuff 604 will keep the cuff 604 in a desired expanded state when a fluid connection is provided between the fluid reservoir 602 and the cuff 604. This is primarily because only a small level of fluid displacement is required to inflate or deflate the cuff 604. In some examples, the fluid reservoir 602 is implanted in the abdominal space.

[0063] A user can control the urethral control device 600 using the external device 601. In some examples, the user can inflate or deflate the cuff 604 using the external device 601. For example, in response to a user initiating an inflation cycle using the external device 601, the external device 601 can send a wireless signal to the electronic pump assembly 606 to initiate an inflation cycle to transfer fluid from the fluid reservoir 602 to the cuff 604 (e.g., by opening an active valve such that pressure in the fluid reservoir 602 moves fluid through the active valve to the cuff 604). In some examples, in response to a user initiating a deflation cycle using the external device 601, the external device 601 can send a wireless signal to the electronic pump assembly 606 to initiate a deflation cycle to transfer fluid from the cuff 604 to the fluid reservoir 602.

[0064] Detailed embodiments have been discussed in this specification. However, it is understood that the disclosed embodiments of the present invention are merely examples that can be embodied in various forms. Therefore, the specific structural and functional details disclosed in this specification should not be interpreted as limiting, but only as a representative basis for teaching those skilled in the art how to vary these embodiments into virtually any suitable detailed structure. Furthermore, the terms and phrases used in this specification are not limiting, but are intended to provide an understandable description of the disclosure of the present invention.

[0065] The terms "a" or "an," as used herein, are defined as one or more than one. The term "another," as used herein, is defined as at least a second or a third or more. The terms "including" and / or "having," as used herein, are defined as comprising (i.e., an open transition). The terms "coupled" or "movably coupled," as used herein, are defined as connected, but not necessarily directly and mechanically.

[0066] In general, the above-described embodiments relate to bodily implants. In this specification, the term patient or user may be used for an individual who may benefit from the medical device or method disclosed in the present disclosure. For example, a patient may be an individual whose body is implanted with a medical device or method of operating the same disclosed by the present disclosure. For example, in some embodiments, a patient may be a human being.

[0067] While certain features of the implementations described above have been illustrated as described herein, many modifications, substitutions, variations, and equivalents will now occur to those of ordinary skill in the art, and it is therefore to be understood that the claims are intended to cover all such modifications and variations as fall within the embodiments. [Explanation of symbols]

[0068] 118 Active Valve 140 Piezoelectric Elements 142 Protrusion 146 Diaphragm Actuator 151 Opening

Claims

1. 1. An active valve for an implantable device, comprising: A bottom plate defining an opening; A piezoelectric element; a diaphragm actuator coupled to the piezoelectric element; a protrusion coupled to the diaphragm actuator; Including, The diaphragm actuator is configured to, in response to the piezoelectric element being actuated, move the protrusion in a first direction into the opening until the protrusion contacts a portion of the base plate.

2. The active valve of claim 1 , wherein the projection includes a tapered conical portion.

3. The active valve of claim 1 or 2, wherein the protrusion comprises a metal-based material.

4. The active valve of any one of claims 1 to 3, wherein the opening comprises a tapered conical hole.

5. The active valve of any one of claims 1 to 4, wherein the diaphragm actuator comprises a metal-based material.

6. The active valve of any one of claims 1 to 5, wherein the diaphragm actuator is coupled to the base plate.

7. 7. An active valve as described in any one of claims 1 to 6, wherein the diaphragm actuator includes a first surface and a second surface, the piezoelectric element is coupled to the first surface of the diaphragm actuator, and the protrusion is coupled to the second surface of the diaphragm actuator.

8. The active valve of any preceding claim, wherein the diaphragm actuator comprises a metal-based material.

9. An active valve as claimed in any preceding claim, wherein at least a portion of the protrusion is disposed outside the opening in the base plate in response to the piezoelectric element not being activated.

10. 1. An implantable device comprising: a fluid reservoir configured to hold a fluid; an expandable member; an electronic pump assembly including a controller and an active valve; The active valve comprises: A base plate defining the opening; Piezoelectric element, a diaphragm actuator coupled to the piezoelectric element; and a protrusion coupled to the diaphragm actuator; Including, The controller is configured to activate the piezoelectric element to move the protrusion in a first direction into the opening until the protrusion contacts a portion of the base plate.

11. The implantable device of claim 10 , wherein the controller is configured to deactivate the piezoelectric element to move at least a portion of the projection out of the opening.

12. 12. The implantable device of claim 10 or 11, wherein the protrusion comprises a metal needle portion, the metal needle portion comprising a tapered cone portion, the base plate comprises a metal based material, and the opening on the base plate comprises a tapered cone hole configured to receive the tapered cone portion.

13. the diaphragm actuator is welded to the bottom plate; An implantable device according to any one of claims 10 to 12, wherein the piezoelectric element is bonded to the diaphragm actuator using an epoxy based material.

14. 1. A method of actuating an active valve in an implantable device, comprising: receiving a first control signal to apply a voltage to a piezoelectric element of an active valve of an implantable device, the active valve including a base plate defining an opening, a diaphragm actuator coupled to the piezoelectric element, and a protrusion coupled to the diaphragm actuator; in response to actuation of the piezoelectric element, moving the protrusion in a first direction into the opening in the base plate until the protrusion contacts a portion of the base plate; The method includes:

15. receiving a second control signal to not apply the voltage to the piezoelectric element of the active valve; 15. The method of claim 14, further comprising: in response to the second control signal, moving the protrusion in a second direction such that at least a portion of the protrusion is disposed outside the opening in the base plate.

16. 1. An active valve for an implantable device, comprising: A bottom plate defining an opening; A piezoelectric element; a diaphragm actuator coupled to the piezoelectric element; a protrusion coupled to the diaphragm actuator; Including, The diaphragm actuator is configured, in response to the piezoelectric element being actuated, to move the protrusion in a first direction into the opening until the protrusion contacts a portion of the base plate, an active valve.

17. The active valve of claim 16 , wherein the projection includes a tapered conical portion.

18. The active valve of claim 16 , wherein the protrusion comprises a metal-based material.

19. The active valve of claim 16 , wherein the opening comprises a tapered conical hole.

20. The active valve of claim 16 , wherein the diaphragm actuator comprises a metal-based material.

21. The active valve of claim 16 , wherein the diaphragm actuator is coupled to the base plate.

22. 17. The active valve of claim 16, wherein the diaphragm actuator includes a first surface and a second surface, the piezoelectric element being coupled to the first surface of the diaphragm actuator and the protrusion being coupled to the second surface of the diaphragm actuator.

23. The active valve of claim 16 , wherein the diaphragm actuator comprises a metal-based material.

24. The active valve of claim 16 , wherein at least a portion of the protrusion is disposed outside the opening in the base plate in response to the piezoelectric element not being actuated.

25. 1. An implantable device comprising: a fluid reservoir configured to hold a fluid; an expandable member; an electronic pump assembly including a controller and an active valve; The active valve comprises: A base plate defining the opening; Piezoelectric element, a diaphragm actuator coupled to the piezoelectric element; and a protrusion coupled to the diaphragm actuator; Including, The controller is configured to activate the piezoelectric element to move the protrusion in a first direction into the opening until the protrusion contacts a portion of the base plate.

26. 26. The implantable device of claim 25, wherein the controller is configured to deactivate the piezoelectric element to move at least a portion of the projection out of the opening.

27. 26. The implantable device of claim 25, wherein the protrusion comprises a metal needle portion, the metal needle portion comprising a tapered conical portion.

28. 28. The implantable device of claim 27, wherein the base plate comprises a metal based material and the opening on the base plate comprises a tapered conical hole configured to receive the tapered conical portion.

29. 26. The implantable device of claim 25, wherein the diaphragm actuator is welded to the base plate.

30. 26. The implantable device of claim 25, wherein the piezoelectric element is bonded to the diaphragm actuator using an epoxy-based material.

31. 26. The implantable device of claim 25, wherein the opening is an inlet port configured to receive a fluid and the base plate defines an outlet port for exhausting the fluid.

32. 32. The implantable device of claim 31, wherein the inlet port is coupled to the expandable member and the outlet port is coupled to the fluid reservoir.

33. 1. A method of actuating an active valve in an implantable device, comprising: receiving a first control signal to apply a voltage to a piezoelectric element of an active valve of an implantable device, the active valve including a base plate defining an opening, a diaphragm actuator coupled to the piezoelectric element, and a protrusion coupled to the diaphragm actuator; in response to actuation of the piezoelectric element, moving the protrusion in a first direction into the opening in the base plate until the protrusion contacts a portion of the base plate; The method includes:

34. receiving a second control signal to not apply the voltage to the piezoelectric element of the active valve; 34. The method of claim 33, further comprising: in response to the second control signal, moving the protrusion in a second direction such that at least a portion of the protrusion is disposed outside the opening in the base plate.

35. 34. The method of claim 33, further comprising forming a metal-to-metal seal with the projection and the base plate.

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