CN118922155A - Electronic pump assembly for implantable device with active valve - Google Patents

Abstract

According to one aspect, an active valve (118) for an implantable device includes a substrate (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. The diaphragm actuator is configured to move the protrusion into the opening in a first direction in response to the piezoelectric element being activated until the protrusion contacts a portion of the substrate.

Description

Electronic pump assembly for implantable device with active valve

Cross Reference to Related Applications

The present application is a continuation of and claims priority from U.S. non-provisional patent application Ser. No.18/182,607, entitled "AN ELECTRONIC PUMP ASSEMBLY FOR AN IMPLANTABLE DEVICE HAVING AN ACTIVE VALVE (electronic pump assembly for implantable device with active valve)" filed on day 13, 2023, which claims priority from U.S. provisional patent application Ser. No.63/269,447, entitled "AN ELECTRONIC PUMP ASSEMBLY FOR AN IMPLANTABLE DEVICE HAVING AN ACTIVE VALVE (electronic pump assembly for implantable device with active valve)" filed on day 16, 2022, the disclosure of which is incorporated herein by reference in its entirety.

The present application also claims priority from U.S. provisional application No.63/269,447 filed on 3/16 of 2022, the disclosure of which is incorporated herein by reference in its entirety.

Technical Field

The present disclosure relates generally to body implants, and more particularly to body implants such as electronic implantable devices with active valves.

Background

The implantable device may include a valve to allow or prevent fluid flow between components of the implantable device. In some examples, conventional valves may not provide sufficient clearance to allow a desired flow rate while minimizing leakage through the valve.

Disclosure of Invention

According to one aspect, an active valve for an implantable device includes a substrate defining an opening, a piezoelectric element, a diaphragm actuator coupled to the piezoelectric element, and a protrusion coupled to the diaphragm actuator. The diaphragm actuator is configured to move the protrusion into the opening in a first direction in response to the piezoelectric element being activated until the protrusion contacts a portion of the substrate.

The active valve may include one or more (or any combination) of the following features. The protrusion includes a tapered conical section. The protrusions comprise a metal-based material. The opening includes a tapered conical bore. The diaphragm actuator includes a metal-based material. The diaphragm actuator is coupled to the base plate. 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. The diaphragm actuator includes a metal-based material. At least a portion of the protrusion is disposed outside the opening of the substrate in response to the piezoelectric element being unactuated.

According to one aspect, an implantable device includes a fluid reservoir configured to hold a fluid, an inflatable member, and an electronic pump assembly including a controller and an active valve. The active valve includes a substrate 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 into the opening in a first direction until the protrusion contacts a portion of the substrate. 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 conical portion. The substrate comprises a metal-based material, and the opening on the substrate comprises a tapered cone hole configured to receive the tapered cone portion. The diaphragm actuator is soldered to the substrate. The piezoelectric element is coupled to the diaphragm actuator through an epoxy-based material. The opening is an inlet port configured to receive a fluid, and the substrate defines an outlet port to output the fluid. The inlet port is coupled to the expandable member and the outlet port is coupled to the fluid reservoir.

According to one aspect, a method for 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 an implantable device, the active valve including a substrate 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 into the opening of the substrate in the first direction until the protrusion contacts a portion of the substrate. In some examples, the method includes receiving a second control signal to not apply a voltage to the piezoelectric element of the active valve, and moving the protrusion in a second direction in response to the second control signal such that at least a portion of the protrusion is disposed outside the opening of the substrate. In some examples, the method includes forming a metal-to-metal seal by the protrusion and the substrate.

Drawings

Fig. 1A illustrates an implantable device having an active valve according to one aspect.

FIG. 1B illustrates an example of an active valve according to one aspect.

Fig. 2A illustrates an example of a diaphragm actuator and protrusion of an active valve according to one aspect.

Fig. 2B illustrates an example of a substrate and a diaphragm actuator according to an aspect.

Fig. 2C illustrates an example of a diaphragm actuator coupled to a substrate according to an aspect.

Fig. 2D illustrates an example of a piezoelectric element coupled to a diaphragm actuator according to an aspect.

Fig. 2E illustrates an example of an active valve in an open position according to one aspect.

FIG. 3 illustrates a flow chart describing an exemplary operation of an active valve according to one aspect.

FIG. 4 illustrates a flow chart describing exemplary operations of fabricating an active valve according to one aspect.

Fig. 5 illustrates an example of an inflatable penile prosthesis according to one aspect.

Fig. 6 illustrates an example of an artificial urinary sphincter apparatus in accordance with an aspect.

Detailed Description

The present disclosure relates to an active valve that may improve the performance of an implantable device. For example, the active valve discussed herein may achieve a relatively constant flow rate (over a period of time) while minimizing leakage past the active valve. The active valve may comprise a piezoelectric diaphragm valve. The active valve is configured to transition from an open position in which fluid is allowed to pass through the active valve and a closed position in which fluid is prevented from being delivered through the active valve. In some examples, in the closed position, the active valve provides a metal-to-metal seal to prevent the transfer of fluid through the active valve. In some examples, the metal-to-metal seal may provide constant performance (e.g., considering that metal working may allow for tighter tolerances than would be required for a rubber-based material). In some examples, the active valve does not include a rubber-based material (e.g., a rubber-based ring member or an O-ring) to provide a seal, which may minimize the risk of adding particles to the fluid (e.g., saline) (e.g., most rubber-based materials may wear during operation).

The active valve may include a diaphragm actuator coupled to the protrusion. The diaphragm actuator may comprise a metal-based material. In some examples, the diaphragm actuator may be a thin flexible member (e.g., a circular/cylindrical member) of metallic material (e.g., foil). In some examples, the protrusion is a metal needle portion. In some examples, the metal needle portion includes a tapered conical portion. The protrusion may be welded to a surface (e.g., a central portion) of the diaphragm actuator. The active valve includes a substrate defining an inlet port and an outlet port. When the active valve is in the open position, fluid may be delivered from the inlet port to the outlet port. When the active valve is in the closed position, fluid may be prevented from being delivered from the inlet port to the outlet port. The substrate may be a metal pillar portion. The inlet port is an opening (e.g., a tapered conical bore) configured to receive the protrusion (to block flow). For example, the base plate is coupled (e.g., welded) to the diaphragm actuator such that the protrusions are aligned with the openings. The active valve includes a piezoelectric element coupled to a diaphragm actuator (e.g., via an epoxy material). In some examples, the piezoelectric element is a structure configured to change the shape of the element when a voltage is applied.

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

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 may include an inflatable member, an electronic pump assembly, and a fluid reservoir. The electronic pump assembly may transfer fluid between the fluid reservoir and the inflatable member without requiring a user to manually operate the pump ball. For example, fluid delivery between the expandable member and the fluid reservoir is electrically controlled.

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 to control the inflatable member. A controller (e.g., processor, driver) may control (e.g., actuate, activate, deactivate, move, etc.) the pump and active valve to move fluid between the expandable member and the fluid reservoir to transition the expandable member between the expanded state and the contracted state. In some examples, a pump is activated to deliver fluid to the expandable member and an active valve is disposed in a fluid passageway for evacuating the expandable member. In some examples, the controller may move the active valve to the open position to deflate the expandable member. In some examples, the active valve is switched to an open position to deliver fluid from the fluid reservoir to the expandable member during an expansion cycle, and the pump is activated to deliver fluid from the expandable member to the fluid reservoir during a contraction cycle.

Fig. 1A illustrates an implantable device 100 according to one aspect. The implantable device 100 may include 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. 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 may include any type of medical device that delivers fluid between components of the implantable device 100.

Fig. 1B shows an example of an active valve 118. One or more active valves 118 may be included in 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 past the active valve 118. In some examples, the active valve 118 comprises a piezoelectric diaphragm valve. The active valve 118 is configured to transition from an open position (in which fluid is allowed to pass through the active valve 118) and a closed position (in which fluid is prevented from being delivered through the active valve 118).

In some examples, in the closed position, the active valve 118 provides a metal-to-metal seal to prevent the transfer of fluid through the active valve 118. In some examples, the metal-to-metal seal may provide constant performance (e.g., considering that metal working may allow for tighter tolerances than would be required for a rubber-based material). In some examples, the active valve 118 does not include a rubber-based material (e.g., a rubber-based ring member or an O-ring) to provide a seal, which may minimize the risk of adding particles to the fluid (e.g., saline) (e.g., most rubber-based materials may wear during operation).

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

Referring to fig. 1A, the active valve 118 may be connected to the controller 114 of the electronic pump assembly 106 and may 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 for evacuating the expandable member 104 (e.g., during a deflation cycle). In some examples, the active valve 118 is disposed in a fluid passage 124 for filling the expandable member 104 (e.g., during an expansion cycle). In some examples, the active valve 118 may transition to a closed position to maintain (e.g., substantially maintain) pressure in the expandable member 104. In some examples, the active valve 118 may be switched to an open position to deliver fluid back to the fluid reservoir 102, relieve pressure in the expandable member 104, and/or allow fluid to return to the expandable member 104. In some examples, the active valve 118 may be used to maintain (e.g., substantially maintain) a partial inflation pressure.

Referring to fig. 1B, the active valve 118 may include a diaphragm actuator 146 coupled to the protrusion 142. The diaphragm actuator 146 may comprise a metal-based material. In some examples, the diaphragm actuator 146 may be a thin flexible member (e.g., a circular or cylindrical portion) of metallic material (e.g., foil). In some examples, the protrusions 142 comprise a metal-based material. In some examples, the protrusion 142 includes a metal needle portion. In some examples, the protrusion 142 includes a tapered conical portion. The protrusion 142 may be coupled to a portion of the diaphragm actuator 146. In some examples, the protrusion 142 is welded to a surface (e.g., a central portion) of the diaphragm actuator 146. The active valve 118 includes a substrate 148 defining an inlet port 152 and an outlet port 150. When the active valve 118 is in the open position, fluid may be delivered from the inlet port 152 to the outlet port 150.

When the active valve 118 is in the closed position, fluid may be prevented from being delivered from the inlet port 152 to the outlet port 150. The substrate 148 may be a metal pillar portion. The inlet port 152 is an opening 151 (e.g., a tapered conical bore) configured to receive the projection 142 when the active valve 118 is in the closed position. The base plate 148 is coupled (e.g., welded) to the diaphragm actuator 146 such that the protrusions 142 are aligned with the openings 151 (or inlet ports 152). The active valve 118 includes a piezoelectric element 140 coupled to a diaphragm actuator 146 via an epoxy material 144. In some examples, the piezoelectric element 140 is configured to move (e.g., bend) when a voltage is applied to the piezoelectric element 140.

In response to the piezoelectric element 140 being activated (e.g., a voltage being applied to the piezoelectric element 140), movement of the piezoelectric element 140 may move the diaphragm actuator 146 toward (e.g., bend toward) the substrate 148 such that the protrusion 142 moves into the opening 151 of the substrate 148 in the first direction A1 until the protrusion 142 contacts a portion 141 of the substrate 148 (defining the opening 151), thereby providing a metal-to-metal seal. As shown in fig. 1B, in response to the piezoelectric element 140 being deactivated (e.g., voltage removed from the piezoelectric element 140), the diaphragm actuator 146 moves away (e.g., flexes away) from the substrate 148 in the direction A2 such that at least a portion of the protrusion 142 is disposed outside of the opening 151, thereby allowing fluid to flow through the active valve 118.

Referring back to fig. 1A, in some examples, the inflatable member 104 is an inflatable cuff member configured to be applied around the urethra of the patient. In some examples, the inflatable member 104 is a penile inflatable member (e.g., one or more inflatable cylinders) that may be implanted into the corpora cavernosa of a user's penis. In some examples, fluid reservoir 102 may be implanted in the abdomen or pelvis of a user (e.g., fluid reservoir 102 may be implanted in a lower portion of the abdomen of a user or an upper portion of the pelvis of a user). In some examples, at least a portion of the electronic pump assembly 106 may be implemented within the patient.

The fluid reservoir 102 may include a container having an interior chamber configured to hold or contain a fluid for expanding the expandable member 104. The volumetric capacity of the fluid reservoir 102 may vary depending on the size of the implantable device 100. In some examples, the volumetric capacity of the fluid reservoir 102 may be 3 to 150 cubic centimeters. In some examples, the fluid reservoir 102 is composed of the same material as the expandable member 104. In 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 greater volume of fluid than the expandable member 104.

The implantable device 100 may include a first catheter connector 103 and a second catheter connector 105. Each of the first conduit connector 103 and the second conduit connector 105 may define a lumen configured to deliver 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 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 convey 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 for transporting fluid between the electronic pump assembly 106 and the fluid reservoir 102.

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

The electronic pump assembly 106 can transfer fluid between the fluid reservoir 102 and the expandable member 104 without requiring a user to manually operate the pump (e.g., squeeze and release a pump ball). The electronic pump assembly 106 may monitor, control, and regulate the pressure within the expandable member 104. The electronic pump assembly 106 may include a controller 114, one or more active valves 118, one or more pumps 120, and a pressure sensor 130 (or pressure sensors). The controller 114 may control the pump 120 and the active valve 118 to move fluid between the expandable member 104 and the fluid reservoir 102 to transition the expandable member 104 between the expanded state and the contracted state. The pressure sensor 130 may monitor the pressure of the expandable member 104. The controller 114 may 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 of the expandable member 104. The controller 114 may send control signals to the pump 120 and the active valve 118 to expand or contract the expandable member 104. In some examples, control of the expanded state and the contracted state is based on wireless signals 109 received from an external device 101 operated by the patient (and the pressure of the expandable member 104 detected from the pressure sensor 130). For example, the patient may use the external device 101 to place the expandable member 104 in an expanded state or a contracted state, which causes the external device 101 to send the wireless signal 109 to the controller 114.

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

Electronic pump assembly 106 may include an antenna 112 configured to wirelessly transmit (and receive) wireless signals 109 from external device 101. The external device 101 may be any type of component capable of communicating with the electronic pump assembly 106. The external device 101 may be a computer, a smart phone, a tablet computer, a pendant, a key chain, etc. The user may use the external device 101 to control the implantable device 100. In some examples, the user may use the external device 101 to expand or contract the expandable member 104. For example, in response to a user initiating an inflation cycle using external device 101 (e.g., selecting user control on external device 101), external device 101 may send wireless signal 109 to electronic pump assembly 106 to initiate an inflation cycle (received via antenna 112), wherein controller 114 may control active valve 118 and pump 120 to inflate inflatable member 104 to a target inflation pressure. In some examples, the controller 114 may cause the active valve 118 to be in a closed position and the pump to operate to move fluid from the fluid reservoir 102 to the expandable member 104.

In some examples, in response to a user initiating a deflation cycle using external device 101 (e.g., selecting user control on external device 101), external device 101 may send wireless signal 109 to electronic pump assembly 106 to initiate the deflation cycle (received via antenna 112), wherein controller 114 may control active valve 118 (and pump 120, in some examples) to deliver fluid from inflatable member 104 to fluid reservoir 102. For example, the controller 114 may control the active valve 118 to move to an open position to allow fluid to be delivered from the expandable member 104 to the fluid reservoir 102. In some examples, the controller 114 may control one or more pumps 120 to further move fluid from the expandable member 104 to the fluid reservoir 102 during a deflation cycle. In some examples, during the deflation cycle, fluid is delivered back until the pressure in the expandable member 104 reaches the partial inflation pressure. In some examples, the controller 114 may automatically determine to initiate a retraction cycle, which causes the controller 114 to control the active valve 118 (and pump 120, in some examples) to deliver fluid back to the fluid reservoir 102.

The controller 114 may 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 driver is a separate component from the controller 114. The controller 114 may be communicatively coupled to the active valve 118, the pump 120, and the pressure sensor 130. In some examples, the controller 114 is connected to the active valve 118, the pump 120, and the pressure sensor 130 via wired data lines. The controller 114 may include a processor 113 and a memory device 115.

The processor 113 may be formed in a substrate configured to carry out one or more machine-executable instructions or software, firmware, or a combination thereof. The processor 113 may be semiconductor-based, that is, the processor may include semiconductor material capable of executing digital logic. Memory device 115 may store information in a format that may be read and/or executed by processor 113. The memory device 115 may store executable instructions that, when executed by the processor 113, cause the processor 113 to perform certain operations discussed herein. The controller 114 may receive data via 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.

The memory device 115 may store control parameters that may be set or modified by a user and/or physician using the external device 101. In some examples, the control parameters may include a target inflation pressure and/or a partial inflation pressure. In some examples, the target inflation pressure is a maximum (or desired) pressure allowed in the inflatable member 104. In some examples, the partial inflation pressure is a pressure threshold that may more closely simulate the user's natural experience and/or personal comfort. The user or physician may update the control parameters using the external device 101, which may be transmitted to the controller 114 via the antenna 112 and then updated in the memory device 115.

The external device 101 may communicate with the electronic pump assembly 106 over a network. In some examples, the network includes a short range wireless network, such as Near Field Communication (NFC), bluetooth, or infrared communication. In some examples, the network may include the internet (e.g., wi-Fi) and/or other types of data networks, such as a Local Area Network (LAN), wide Area Network (WAN), cellular network, satellite network, or other types of data networks.

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

In some examples, the pumps 120 may include more than two pumps 120, such as three, four, five, six, or more than six pumps 120. For example, pump 120 may include a third pump in parallel with pump 120-2, a fourth pump in parallel with the third pump, and so on. In some examples, the pumps 120 may include one or more pumps 120 in series with one or more other pumps 120. For example, one or more pumps 120 may be in series with pump 120-1. In some examples, one or more pumps 120 may be in series with pump 120-2.

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

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

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

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

Pump 120 may include one or more passive check valves. The passive check valve may help maintain pressure in the expandable member 104. In some examples, pump 120 may include a single passive check valve. In some examples, pump 120 may include a plurality of passive check valves, such as two passive check valves or more than two passive check valves. The passive check valves of the respective pumps 120 may not be controlled directly by the controller 114, but rather based on the pressure between the expandable member 104 and the fluid reservoir 102. The passive check valve may be switched between an open position (wherein fluid is allowed to flow through the passive check valve) and a closed position (wherein fluid is prevented from flowing through the passive check valve). In some examples, the passive check valve transitions to the 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 the open position in response to a negative pressure between the expandable member 104 and the fluid reservoir 102.

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

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

Fig. 2A-2E illustrate an active valve 218 according to one aspect. As shown in fig. 2A, the active valve 218 includes a diaphragm actuator 246 coupled to the protrusion 242. The diaphragm actuator 246 may include a metal-based material. In some examples, the diaphragm actuator 246 may be a thin flexible piece of metallic material (e.g., foil). In some examples, the diaphragm actuator 246 includes a cylindrical portion. The diaphragm actuator 246 includes a first surface 260 and a second surface 262 (as shown in fig. 2B), wherein a distance between the first surface 260 and the second surface 262 defines a thickness of the diaphragm actuator 246. A sidewall 264 extends between the first surface 260 and the second surface 262. The first surface 260 may have a disk shape. The second surface 262 may have a disk shape.

The protrusions 242 may comprise a metal-based material. In some examples, the protrusion 242 is a needle portion (e.g., a metallic needle portion). In some examples, the protrusion 242 includes a tapered portion. In some examples, the protrusion 242 includes a tapered conical portion. The projection 242 includes a first end portion 261 and a second end portion 263. The first end portion 261 may have a size (e.g., diameter) that is smaller than a size (e.g., diameter) of the second end portion 263.

The protrusion 242 is coupled to the diaphragm actuator 246. In some examples, the protrusion 142 is coupled to the diaphragm actuator 246 via a weld portion 254 (e.g., the protrusion 142 is welded to the diaphragm actuator 246). The second end portion 263 of the protrusion 242 may be coupled to the first surface 260 of the diaphragm actuator 246. In some examples, the second end portion 263 of the protrusion 242 is coupled to a central portion of the first surface 260 of the diaphragm actuator 246.

As shown in fig. 2B, the active valve 218 includes a substrate 248. The substrate 248 may include a metal-based material. In some examples, the substrate 248 includes a columnar portion (e.g., a metallic columnar portion). The substrate 248 includes a first surface 271 and a second surface 273, wherein a distance between the first surface 271 and the second surface 273 defines a thickness of the substrate 248. The substrate 248 includes a sidewall 275 extending between a first surface 271 and a second surface 273. In some examples, the diameter of the substrate 248 may be the same (or substantially the same (e.g., within 1 or 2 millimeters)) as the diameter of the diaphragm actuator 246.

The substrate 248 may define an inlet port 252 and an outlet port 250. When the active valve 218 is in the open position (as shown in fig. 2E), fluid may be delivered from the inlet port 252 to the outlet port 250 via the chamber 299 (as shown in fig. 2E). When the active valve 218 is in the closed position, fluid may be prevented from being delivered from the inlet port 152 to the outlet port 150 (e.g., by the protrusion 242). The inlet port 252 is an opening 251 (e.g., a hole) extending through the thickness of the substrate 248. In some examples, the thickness of the substrate 248 is greater than the length of the protrusion 242, wherein the length of the protrusion 242 may 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 substrate 248. In some examples, the shape of the outlet port 250 is different than the shape of the inlet port 252. In some examples, the outlet port 250 is not tapered.

In some examples, the opening 251 includes a tapered cylindrical portion 270 configured to receive the projection 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.

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

Fig. 2E shows the active valve 218 in an open position. The diaphragm actuator 246 moves toward (e.g., flexes toward) the substrate 248 in response to the piezoelectric element 240 being activated (e.g., applying a voltage to the piezoelectric element 240) such that the protrusion 242 moves into the opening 251 of the substrate 248 in the first direction A1 until the protrusion 242 contacts a portion 241 (defining the opening 151) of the substrate 148, thereby providing a metal-to-metal seal. As shown in fig. 2E, the diaphragm actuator 246 moves away (e.g., flexes away) from the substrate 248 in the direction A2 in response to the piezoelectric element 240 being deactivated (e.g., removing a voltage from the piezoelectric element 240) such that at least a portion of the protrusion 242 is disposed outside of the opening 251, thereby allowing fluid to flow through the active valve 218.

FIG. 3 illustrates a flowchart 300 depicting exemplary operations of a method of actuating an active valve of an electronic pump assembly of an inflatable member. Although the operations of fig. 3 are described with reference to the active valve 118 of fig. 1A and 1B, the example operations of the flow chart 300 may be performed by any of the active valve and/or electronic pump assemblies discussed herein.

Operation 302 includes receiving a first control signal to apply a voltage to a piezoelectric element 140 of an active valve 118 of an implantable device 100, the active valve 118 including a substrate 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. Operation 304 includes moving the protrusion 142 in the first direction A1 into the opening 151 of the substrate 148 in response to actuation of the piezoelectric element 140 until the protrusion 142 contacts a portion 141 of the substrate 148.

FIG. 4 illustrates a flowchart 400 depicting exemplary operation of a method of manufacturing an active valve of an electronic pump assembly of an expandable member. Although the operations of fig. 4 are described with reference to the active valve 218 of fig. 2A-2E, the example operations of the flow chart 400 may be performed by any of the active valve and/or electronic pump assemblies discussed herein.

Operation 402 includes coupling protrusion 242 to diaphragm actuator 246. As shown in fig. 2A, the protrusion 242 is coupled to the diaphragm actuator 246 via a weld (e.g., a weld bond). Operation 404 includes coupling the diaphragm actuator 246 to the substrate 248 such that the protrusions 242 are aligned with the openings 251 on the substrate 248. As shown in fig. 2B and 2C, the diaphragm actuator 246 moves toward and contacts the substrate 248, with the projection 242 aligned with the opening 251, and the diaphragm actuator 246 coupled to the substrate (by welding). Operation 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.

Fig. 5 schematically illustrates an inflatable penile prosthesis 500 with an electronic pump assembly 506 according to one aspect. 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 1B or the active valve 218 of fig. 2A-2E. Inflatable penile prosthesis 500 may include inflatable members 504 (e.g., a pair of inflatable cylinders 510), and inflatable cylinders 510 are configured to be implanted in the penis. For example, one of inflatable cylinders 510 may be disposed on one side of the penis while 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 inflation chamber 522, and a second end portion 528 having a rear end 532.

At least a portion of the electronic pump assembly 506 may be implanted within the patient. A pair of conduit connectors 505 may attach electronic pump assembly 506 to inflatable cylinder 510 such that electronic pump assembly 506 is in fluid communication with inflatable cylinder 510. Likewise, the electronic pump assembly 506 may be in fluid communication with the fluid reservoir 502 via the conduit connector 503. The fluid reservoir 502 may be implanted in the abdomen of the user. The expansion chamber 522 of the inflatable cylinder 510 may be disposed within the penis. The first end portion 524 of the inflatable cylinder 510 may be at least partially disposed within the crown portion of the penis. The second end portion 528 may be implanted into a pubic region PR of the patient with the posterior end 532 proximate to the pubic PB.

To implant inflatable column 510, the surgeon first prepares the patient. The surgeon typically makes an incision in the scrotal region (e.g., where the root of the penis meets the top of the scrotum). The surgeon may dilate the corpora cavernosa of the patient from the scrotal incision to prepare the patient to receive inflatable cylinder 510. The corpora cavernosa is one of two parallel erectile tissue columns forming the back of the corpora cavernosa, e.g. two elongated columns extending substantially the length of the penis. The surgeon will also dilate both areas of the pubic region to prepare the patient to receive the second end portion 528. The surgeon may measure the length of the corpora cavernosa from the incision and the dilated area of the pubic area to determine the proper size of the inflatable post 510 to be implanted.

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

The user may use the external device 501 to control the inflatable penile prosthesis 500. In some examples, a user may use external device 501 to expand or contract inflatable cylinder 510. For example, in response to a user initiating an inflation cycle using external device 501, external device 501 may send a wireless signal to electronic pump assembly 506 to initiate an inflation cycle to deliver fluid from fluid reservoir 502 to inflatable cylinder 510. In some examples, in response to a user initiating a deflation cycle using external device 501, external device 501 may send a wireless signal to electronic pump assembly 506 to initiate a deflation cycle to deliver fluid from inflatable cylinder 510 to fluid reservoir 502. In some examples, during the deflation cycle, fluid is delivered back until the pressure in inflatable cylinder 510 reaches a partial inflation pressure.

Fig. 6 illustrates a urinary control device 600 with an electronic pump assembly 606 in accordance with an aspect. The electronic pump assembly 606 may include any of the features of the electronic pump assemblies discussed herein, including the active valve 118 of fig. 1A and 1B or the active valve 218 of fig. 2A-2E. The urinary control device 600 includes a pump assembly 606, a fluid reservoir 602, and a cuff 604.

The fluid reservoir 602 may be a pressure-regulated inflatable balloon or element. The fluid reservoir 602 is in operable fluid communication with the cuff 604 via one or more tube members 603, 605. The fluid reservoir 602 is constructed of a polymeric material that is capable of elastically deforming to reduce the volume of fluid within the fluid reservoir 602 and push the fluid out of the fluid reservoir 602 and into the cuff 604. However, the material of the fluid reservoir 602 may be biased or include a shape memory structure that is generally adapted to maintain the fluid reservoir 602 in its expanded state with a relatively constant fluid volume and pressure. In some examples, such a constant level of pressure applied to the cuff 604 from the fluid reservoir 602 will maintain the cuff 604 in a desired inflated state while providing open fluid communication between the fluid reservoir 602 and the cuff 604. This is due in large part to the small amount of fluid movement required to expand or contract the cuff 604. In some examples, the fluid reservoir 602 is implanted in the abdominal space.

The user may control the urinary control apparatus 600 using the external apparatus 601. In some examples, the user may use the external device 601 to inflate or deflate the cuff 604. For example, in response to a user initiating an inflation cycle using the external device 601, the external device 601 may send a wireless signal to the electronic pump assembly 606 to initiate the inflation cycle to transfer fluid from the fluid reservoir 602 to the cuff 604 (e.g., by opening an active valve, wherein 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 external device 601, external device 601 may send a wireless signal to electronic pump assembly 606 to initiate a deflation cycle to transfer fluid from cuff 604 to fluid reservoir 602.

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

The terms a or an, as used herein, are defined as one or more 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., open transition). The terms "coupled" or "movable coupled," as used herein, are defined as connected, although not necessarily directly, and not necessarily mechanically.

Generally, embodiments relate to body implants. The term "patient" or "user" may hereinafter be used for persons who benefit from the medical devices or methods disclosed in the present disclosure. For example, the patient may be a person whose body is implanted with the medical device or method for operating the medical device disclosed in the present disclosure. For example, in some embodiments, the patient may be a human.

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

Claims (35)

1. An active valve for an implantable device, the active valve comprising:

A substrate defining an opening;

A piezoelectric element;

A diaphragm actuator coupled to the piezoelectric element; and

A protrusion coupled to the diaphragm actuator,

The diaphragm actuator is configured to move the protrusion into the opening in a first direction in response to the piezoelectric element being activated until the protrusion contacts a portion of the substrate.

2. The active valve of claim 1, wherein the protrusion comprises a tapered conical portion.

3. The active valve of claim 1 or2, wherein the protrusion comprises a metal-based material.

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

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

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

7. The active valve of any of claims 1 to 6, wherein the diaphragm actuator comprises 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 of claims 1 to 7, wherein the diaphragm actuator comprises a metal-based material.

9. The active valve of any of claims 1 to 8, wherein at least a portion of the protrusion is disposed outside of the opening of the substrate in response to the piezoelectric element being unactuated.

10. An implantable device, comprising:

A fluid reservoir configured to hold a fluid;

An inflatable member; and

An electronic pump assembly comprising a controller and an active valve, the active valve comprising:

A substrate 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 into the opening in a first direction until the protrusion contacts a portion of the substrate.

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 protrusion out of the opening.

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

13. The implantable device of any one of claims 10 to 12, wherein the diaphragm actuator is welded to the substrate, wherein the piezoelectric element is coupled to the diaphragm actuator by an epoxy-based material.

14. A method for actuating an active valve of an implantable device, the method 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 comprising a substrate 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, the protrusion is moved into the opening of the substrate in a first direction until the protrusion contacts a portion of the substrate.

15. The method of claim 14, further comprising:

receiving a second control signal to not apply a voltage to a piezoelectric element of the active valve; and

In response to the second control signal, the protrusion is moved in a second direction such that at least a portion of the protrusion is disposed outside the opening of the substrate.

16. An active valve for an implantable device, the active valve comprising:

A substrate defining an opening;

A piezoelectric element;

A diaphragm actuator coupled to the piezoelectric element; and

A protrusion coupled to the diaphragm actuator,

The diaphragm actuator is configured to move the protrusion into the opening in a first direction in response to the piezoelectric element being activated until the protrusion contacts a portion of the substrate.

17. The active valve of claim 16, wherein the protrusion comprises 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 bore.

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 substrate.

22. The active valve of claim 16, wherein the diaphragm actuator comprises 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.

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 of the opening of the substrate in response to the piezoelectric element being unactuated.

25. An implantable device, comprising:

A fluid reservoir configured to hold a fluid;

An inflatable member; and

An electronic pump assembly comprising a controller and an active valve, the active valve comprising:

A substrate 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 into the opening in a first direction until the protrusion contacts a portion of the substrate.

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 protrusion out of the opening.

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

28. The implantable device of claim 27, wherein the substrate comprises a metal-based material, the opening on the substrate comprising a tapered cone aperture configured to receive the tapered cone portion.

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

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

31. The implantable device of claim 25, wherein the opening is an inlet port configured to receive a fluid, the substrate defining an outlet port to output the fluid.

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. A method for actuating an active valve of an implantable device, the method 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 comprising a substrate 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, the protrusion is moved into the opening of the substrate in a first direction until the protrusion contacts a portion of the substrate.

34. The method of claim 33, further comprising:

receiving a second control signal to not apply a voltage to a piezoelectric element of the active valve; and

In response to the second control signal, the protrusion is moved in a second direction such that at least a portion of the protrusion is disposed outside the opening of the substrate.

35. The method of claim 33, further comprising:

A metal-to-metal seal is formed by the protrusion and the substrate.