Fluid control system for an implantable inflatable device

Abstract

An implantable fluid-actuated device may include a fluid reservoir configured to hold a fluid, an inflatable member, and an electronic fluid control system that transfers fluid between the fluid reservoir and the inflatable member. The fluid control system includes at least one pump and at least one valve including a piezoelectric actuator. The piezoelectric actuator includes a diaphragm and a piezoelectric element coupled to the diaphragm. The piezoelectric element deforms in response to a voltage applied by an electronic control system of the fluid control system. The diaphragm deforms in response to deformation of the piezoelectric element. The piezoelectric actuator actuates the at least one pump and the at least one valve to control fluid flow based on one of the amount or direction of deformation of the diaphragm.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of and claims priority to U.S. Provisional Patent Application No. 18 / 182,612, entitled "FLUID CONTROL SYSTEM FOR AN IMPLANTABLE INFLATABLE DEVICE," filed March 13, 2023, which claims priority to U.S. Provisional Patent Application No. 63 / 269,437, entitled "FLUID CONTROL SYSTEM FOR AN IMPLANTABLE INFLATABLE DEVICE," filed March 16, 2022, the disclosures of which are incorporated herein by reference in their entireties.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 269,437, filed March 16, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0003] The present disclosure relates generally to body implants, and more particularly to body implants that include a fluid control system having one or more pumps and / or valves that include piezoelectric actuators. [Background technology]

[0004] Active implantable fluid-operated inflatable devices often include one or more pumps that regulate fluid flow between different portions of the implantable device. One or more valves may be disposed within the fluid pathways of the device to direct and control fluid flow to inflate, deflate, pressurize, depressurize, activate, deactivate, etc., different fluid-filled implant components of the device. In some implantable fluid-operated devices, a user may manually operate an implantable pump device to enable transfer of fluid between a reservoir and the fluid-filled implant components of the device. Some patients may find it difficult to operate manually operated implantable pump devices. Furthermore, manual operation of such pump devices may make it difficult to consistently inflate, deflate, pressurize, depressurize, activate, deactivate, etc., the fluid-filled implant components. Inconsistent inflation, deflation, pressurization, depressurization, activation, and / or deactivation of the fluid-filled implant device(s) can adversely affect patient comfort, device effectiveness, and overall patient experience. Precise actuation and control of the fluid control system that controls fluid flow between components of the inflatable device improves the performance and effectiveness of the device and enhances patient comfort and safety. Summary of the Invention [Means for solving the problem]

[0005] In a general aspect, an implantable fluid-actuated inflatable device includes a fluid reservoir, an inflatable member, and a fluid control system configured to control fluid flow between the fluid reservoir and the inflatable member. The fluid control system includes a housing, a fluid architecture defining one or more fluid passages within the housing, and at least one pump and at least one valve disposed within the one or more fluid passages, the at least one pump and at least one valve including a piezoelectric actuator operable in response to a voltage applied by an electronic control system of the fluid control system. The piezoelectric actuator includes a diaphragm and a piezoelectric element mounted on the diaphragm and configured to deform in response to the voltage applied by the electronic control system. The diaphragm is configured to deform in response to deformation of the piezoelectric element mounted on the diaphragm. The piezoelectric actuator actuates the at least one pump and at least one valve to control fluid flow within the one or more fluid passages based on one of the amount of deformation of the diaphragm or the direction of deformation of the diaphragm.

[0006] In some embodiments, the piezoelectric element includes a plate portion attached to the diaphragm and an open portion within the plate portion, the plate portion surrounding the open portion. The location of the open portion of the piezoelectric element can correspond to a region of high bending stress of the piezoelectric actuator during deformation of the piezoelectric actuator. The open portion of the piezoelectric element can be defined by a substantially circular opening in a central portion of the piezoelectric element, with the plate portion forming an annular ring surrounding the open portion.

[0007] In some embodiments, the plate portion includes a plurality of individual segments arranged around the opening. Each of the plurality of individual segments can be individually actuable in response to a voltage applied by an electronic control system of the fluid control system. Each of the plurality of individual segments can be substantially the same size and shape. The plurality of individual segments can be arranged substantially symmetrically around a central plane of the piezoelectric element.

[0008] In some embodiments, the piezoelectric actuator includes a protrusion extending along a peripheral portion of the diaphragm, the contour of which can correspond to the outer periphery contour of the plate portion of the piezoelectric element such that the piezoelectric element is contained within an area of ​​the diaphragm encompassed by the protrusion.

[0009] In some embodiments, the piezoelectric actuator includes a piezoelectric element configured to deform in response to a voltage applied by an electronic control system of the fluid control system, a first plate coupled to a first side of the piezoelectric element and having a convex contour relative to the first side of the piezoelectric element, a second plate coupled to a second side of the piezoelectric element opposite the first side and having a convex contour relative to the second side of the piezoelectric element, and a diaphragm coupled to the second plate. The diaphragm can be configured to deform in response to deformation of the piezoelectric element. A distance between a central portion of the first plate and the diaphragm can be greater than a distance between a peripheral portion of the first plate and the diaphragm, and a distance between a central portion of the second plate and the diaphragm can be greater than a distance between a peripheral portion of the second plate and the diaphragm. The peripheral portion of the first plate can be coupled to the peripheral portion of a first side of the piezoelectric element, the peripheral portion of the second plate can be coupled to the peripheral portion of a second side of the piezoelectric element, the diaphragm can be coupled to a central portion of a central portion of the second plate, and the second plate can be disposed between the diaphragm and the piezoelectric element.

[0010] In some embodiments, the piezoelectric element is configured to expand in a planar direction in response to an applied first voltage and contract in a planar direction in response to an applied second voltage, and the first and second plates are configured to deform in response to the expansion or contraction of the piezoelectric element. In some embodiments, the first plate is configured to deform in a first direction and the second plate is configured to deform in a second direction opposite the first direction in response to the expansion of the piezoelectric element to decrease the distance between the first and second plates, the first plate is configured to deform in the second direction and the second plate is configured to deform in the first direction in response to the contraction of the piezoelectric element to increase the distance between the first and second plates, and the diaphragm is configured to deform in the first direction in response to the expansion of the piezoelectric element and the diaphragm is configured to deform in the second direction in response to the contraction of the piezoelectric element.

[0011] In some embodiments, the piezoelectric element includes: a piezoelectric layer stack including a plurality of piezoelectric layers arranged in sequence from a first end to a second end of the stack of piezoelectric layers along a mounting surface of the diaphragm; a first support bracket coupling a first piezoelectric layer at the first end of the stack of piezoelectric layers to the mounting surface of the diaphragm; and a second support bracket coupling a second piezoelectric layer at the second end of the stack of piezoelectric layers to the mounting surface of the diaphragm. The stack of piezoelectric layers can be configured to expand in response to an applied first voltage, the first end of the stack of piezoelectric layers can be configured to pivot at the first support bracket in a first pivot direction in response to the expansion of the stack of piezoelectric layers, and the second end of the stack of piezoelectric layers can be configured to pivot at the second support bracket in a second pivot direction in response to the expansion of the stack of piezoelectric layers. The stack of piezoelectric layers can be configured to contract in response to an applied second voltage, a first end of the stack of piezoelectric layers can be configured to pivot in a second pivot direction on the first support bracket in response to contraction of the stack of piezoelectric layers, and a second end of the stack of piezoelectric layers can be configured to pivot in the first pivot direction on the second support bracket in response to contraction of the stack of piezoelectric layers. The diaphragm can be configured to deform in a first direction in response to expansion of the stack of piezoelectric layers. The diaphragm can be configured to deform in a second direction in response to contraction of the stack of piezoelectric layers. A space can be formed between a bottom of the piezoelectric element and a mounting surface of the diaphragm, and a distance between the bottom of the piezoelectric element and the mounting surface of the diaphragm can increase in response to expansion of the stack of piezoelectric layers and decrease in response to contraction of the stack of piezoelectric layers.

[0012] In another general aspect, an implantable fluid-actuated inflatable device includes a fluid reservoir, an inflatable member, and a fluid control system configured to control fluid flow between the fluid reservoir and the inflatable member, the fluid control system including a housing, a fluid architecture defining one or more fluid passages within the housing, and at least one pump and at least one valve disposed within the one or more fluid passages, the at least one pump and at least one valve including a piezoelectric actuator operable in response to a voltage applied by an electronic control system of the fluid control system. The piezoelectric actuator can include a diaphragm mounted within one or more of the fluid passages defined within the housing to control fluid flow through the fluid passages, and a piezoelectric element mounted on the diaphragm and configured to deform in response to a voltage applied by the electronic control system. The diaphragm can be configured to deform in response to deformation of the piezoelectric element mounted on the diaphragm. The piezoelectric element can include a plate portion mounted on the diaphragm and an open portion within the plate portion, the plate portion surrounding the open portion.

[0013] In some embodiments, the open portion of the piezoelectric element is defined by a substantially circular opening in a central portion of the piezoelectric element. The plate portion forms an annular ring surrounding the open portion. The plate portion can include a plurality of individual segments arranged around the opening. The location of the open portion of the piezoelectric element can correspond to a high bending stress region of the piezoelectric actuator during deformation of the piezoelectric actuator. In some embodiments, each of the plurality of individual segments is individually operable in response to a voltage applied by an electronic control system of the fluid control system. In some embodiments, at least one of the plurality of individual segments is operable in response to a voltage applied by the electronic control system of the fluid control system to control a flow of fluid through the fluid passage, and at least one of the plurality of individual segments is configured to sense a pressure of the fluid in the fluid passage. In some embodiments, each of the plurality of individual segments is substantially the same size and shape, and the plurality of individual segments are arranged substantially symmetrically around a central plane of the piezoelectric element.

[0014] In some embodiments, the diaphragm includes a protrusion extending along a peripheral portion of the diaphragm, the contour of which can correspond to the outer circumferential contour of the plate portion of the piezoelectric element such that the piezoelectric element is contained within an area of ​​the diaphragm surrounded by the protrusion.

[0015] In another general aspect, an implantable fluid-actuated inflatable device can include a fluid reservoir, an inflatable member, and a fluid control system coupled between the fluid reservoir and the inflatable member and configured to control fluid flow between the fluid reservoir and the inflatable member. The fluid control system can include a housing, a fluid architecture defining one or more fluid passages within the housing, and at least one pump and at least one valve disposed within the one or more fluid passages, the at least one pump and the at least one valve including a piezoelectric actuator operable in response to a voltage applied by an electronic control system of the fluid control system. In some embodiments, the piezoelectric actuator includes a piezoelectric element configured to deform in response to a voltage applied by the electronic control system of the fluid control system, a first plate coupled to a first side of the piezoelectric element and having a convex contour relative to the first side of the piezoelectric element, a second plate coupled to a second side opposite the first side of the piezoelectric element and having a convex contour relative to the second side of the piezoelectric element, and a diaphragm coupled to the second plate and configured to deform in response to a deformation of the piezoelectric element.

[0016] In some embodiments, the distance between the central portion of the first plate and the piezoelectric element is greater than the distance between the peripheral portion of the first plate and the piezoelectric element, and the distance between the central portion of the second plate and the piezoelectric element is greater than the distance between the peripheral portion of the second plate and the piezoelectric element. In some embodiments, the peripheral portion of the first plate is coupled to the peripheral portion of a first side of the piezoelectric element, the peripheral portion of the second plate is coupled to the peripheral portion of a second side of the piezoelectric element, a diaphragm is coupled to the central portion of the central portion of the second plate, and the second plate is disposed between the diaphragm and the piezoelectric element. The piezoelectric element can be configured to expand in a planar direction in response to an applied first voltage and to contract in a planar direction in response to an applied second voltage. The first plate and the second plate can be configured to deform in response to the expansion or contraction of the piezoelectric element.

[0017] In some embodiments, the first plate is configured to deform in a first direction and the second plate is configured to deform in a second direction opposite the first direction in response to an expansion of the piezoelectric element to decrease the distance between the first and second plates. In some embodiments, the first plate is configured to deform in the second direction and the second plate is configured to deform in the first direction in response to a contraction of the piezoelectric element to increase the distance between the first and second plates. The diaphragm can be configured to deform in the first direction in response to an expansion of the piezoelectric element and the diaphragm can be configured to deform in the second direction in response to a contraction of the piezoelectric element.

[0018] In another general aspect, an implantable fluid-actuated inflatable device can include a fluid reservoir, an inflatable member, and a fluid control system configured to control fluid flow between the fluid reservoir and the inflatable member. The fluid control system can include a housing, a fluid architecture defining one or more fluid passages within the housing, and at least one pump and at least one valve disposed within the one or more fluid passages, the at least one pump and the at least one valve including a piezoelectric actuator operable in response to a voltage applied by an electronic control system of the fluid control system. The piezoelectric actuator can include a diaphragm mounted within one of the one or more fluid passages defined within the housing to control the flow of fluid through the fluid passage, and a piezoelectric element mounted on the diaphragm and configured to deform in response to a voltage applied by the electronic control system of the fluid control system. The diaphragm can be configured to deform in response to a deformation of the piezoelectric element mounted on the diaphragm. The piezoelectric element may include a piezoelectric layer stack including a plurality of piezoelectric layers arranged in sequence from a first end to a second end of the piezoelectric layer stack, a first support bracket coupling the first piezoelectric layer at the first end of the piezoelectric layer stack to a mounting surface of the diaphragm, and a second support bracket coupling the second piezoelectric layer at the second end of the piezoelectric layer stack to the mounting surface of the diaphragm.

[0019] In some embodiments, multiple piezoelectric layers can be arranged in sequence along the mounting surface of the diaphragm from a first end to a second end of the stack of piezoelectric layers. The stack of piezoelectric layers can be configured to expand in response to an applied first voltage. The first end of the stack of piezoelectric layers can be configured to pivot in a first pivot direction at the first support bracket in response to the expansion of the stack of piezoelectric layers, and the second end of the stack of piezoelectric layers can be configured to pivot in a second pivot direction at the second support bracket in response to the expansion of the stack of piezoelectric layers. In some embodiments, the stack of piezoelectric layers is configured to contract in response to an applied second voltage, the first end of the stack of piezoelectric layers can be configured to pivot in a second pivot direction at the first support bracket in response to the contraction of the stack of piezoelectric layers, and the second end of the stack of piezoelectric layers can be configured to pivot in the first pivot direction at the second support bracket in response to the contraction of the stack of piezoelectric layers. In some embodiments, the diaphragm is configured to deform in a first direction in response to expansion of the stack of piezoelectric layers, and the diaphragm is configured to deform in a second direction in response to contraction of the stack of piezoelectric layers. In some embodiments, a space is formed between a bottom of the piezoelectric element and a mounting surface of the diaphragm, and the distance between the bottom of the piezoelectric element and the mounting surface of the diaphragm increases in response to expansion of the stack of piezoelectric layers and decreases in response to contraction of the stack of piezoelectric layers. [Brief explanation of the drawings]

[0020] [Figure 1] 1 is a block diagram of an implantable fluid-actuated inflatable device according to one embodiment. [Figure 2A] FIG. 1 illustrates a first system including a first example implantable fluid-actuated inflatable device according to one embodiment. [Figure 2B] FIG. 1 illustrates a second system including a second example implantable fluid-actuated inflatable device according to one embodiment. [Figure 3] 1 is a schematic diagram of a fluid architecture of an implantable fluid-actuated inflatable device according to one embodiment. [Figure 4A]FIG. 1 is a schematic diagram of an example active valve in an open state. [Figure 4B] FIG. 4B is a schematic diagram of the example active valve shown in FIG. 4A in a closed state. [Figure 5A] FIG. 1 is a top perspective view of an example piezoelectric actuator according to one embodiment. [Figure 5B] 5B is a cross-sectional view of the example piezoelectric actuator shown in FIG. 5A taken along line AA in FIG. 5A. [Figure 5C] 5A and 5B in a first actuation state. FIG. [Figure 5D] 5A and 5B in a second actuation state. FIG. [Figure 6] FIG. 1 is a top perspective view of an example piezoelectric actuator according to one embodiment. [Figure 7A] FIG. 1 is a side view of an example piezoelectric actuator according to one aspect. [Figure 7B] 7B is a cross-sectional view of the example piezoelectric actuator shown in FIG. 7A taken along line BB in FIG. 5A. [Figure 7C] 7B is a cross-sectional view of the example piezoelectric actuator shown in FIG. 7A coupled to a diaphragm. [Figure 7D] 7A-7C in a first operating state. [Figure 7E] 7A-7C in a second operating state. FIG. [Figure 8A] FIG. 1 is a top perspective view of an example piezoelectric actuator according to one embodiment. [Figure 8B] 8B illustrates the example piezoelectric actuator shown in FIG. 8A in a first actuated state. [Figure 8C] 8B illustrates the example piezoelectric actuator shown in FIG. 8A in a second actuated state. [Figure 9A] FIG. 1 is a top perspective view of an example piezoelectric actuator according to one embodiment. [Figure 9B] 9B is a cross-sectional view of the example piezoelectric actuator shown in FIG. 9A taken along line HH in FIG. 9A. DETAILED DESCRIPTION OF THE INVENTION

[0021] Detailed embodiments are disclosed herein. However, it should be understood that the disclosed embodiments are merely examples and can be embodied in various forms. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but merely as a basis for the claims and as representative basis for teaching those skilled in the art that these embodiments can be variously employed in substantially any suitable detailed configuration. Furthermore, the terms and expressions used herein are not intended to be limiting, but rather to provide an understandable description of the present disclosure.

[0022] The term "a" or "an" as used herein is defined as one or more. The term "another" as used herein is defined as at least a second or more. The terms "including" and / or "having" as used herein are defined as comprising (i.e., an open transition). The terms "coupled" or "movably coupled" as used herein are defined as connected, although not necessarily directly and mechanically.

[0023] Generally, embodiments relate to body implants. Hereinafter, the terms patient or user can be used to refer to a person who can benefit from the medical device or method disclosed in this disclosure. For example, a patient can be a person in whose body a disclosed medical device or method of operating a medical device according to the present disclosure is implanted.

[0024] FIG. 1 is a block diagram of an example implantable fluid-actuated inflatable device 100. The example device 100 shown in FIG. 1 includes a fluid reservoir 102, an inflatable member 104, and a fluid control system 106. The fluid control system 106 may include fluid components, such as one or more pumps and one or more valves, configured to transfer fluid between the fluid reservoir 102 and the inflatable member 104. The fluid control system 106 may include one or more sensing devices that sense conditions, such as fluid pressure and fluid flow rate, within the fluid architecture of the inflatable device 100. In some embodiments, the inflatable device 100 includes an electronic control system 108. The electronic control system 108 may enable monitoring and / or control of the operation of various fluid components of the fluid control system 106, and / or communication with one or more sensing devices within the implantable fluid-actuated inflatable device 100, and / or communication with one or more external devices. In some examples, the electronic control system 108 includes components such as a processor, memory, a communication module, a power storage device or battery, a sensing device such as an accelerometer, and other such components configured to enable operation and control of the implantable fluid-actuated inflatable device 100. In some examples, the communication module of the electronic control system 108 may enable communication with one or more external devices, such as an external controller 120.

[0025] In some examples, the external controller 120 includes components such as a user interface, a processor, memory, a communications module, a power transmission module, and other such components that enable operation and control of the external controller 120 and communication with the electronic control system 108 of the inflatable device 100. For example, the memory can store instructions, applications, and the like that the processor of the external controller 120 can execute. The external controller 120 can be configured to receive user input, such as via a user interface, and transmit the user input, such as via a communications module, to the electronic control system 108 for processing, operation, and control of the inflatable device 100. Similarly, the electronic control system 108 can transmit operational information to the external controller 120 via its respective communications module. This can result in the operational status of the inflatable device 100 being provided to a user, or diagnostic information being provided to a physician, such as via a user interface of the external controller 120.

[0026] In some examples, a power transmission module in the external controller 120 enables charging of components of the internal electronic control system 108. In some examples, an external power transmission device 150 separate from the external controller 120 can alternatively or additionally transmit power to charge the internal electronic control system 108. In some embodiments, the external controller 120 can include sensing devices such as pressure sensors, acceleration sensors, and other such sensing devices. An external pressure sensor in the external controller 120 can provide, for example, local atmospheric pressure or an operating pressure to the internal electronic control system 108 to enable the inflatable device 100 to compensate for pressure fluctuations. An accelerometer in the external controller 120 can provide detected patient movement to the internal electronic control system 108 for control of the inflatable device 100.

[0027] The fluid reservoir 102, the inflatable member 104, the fluid control system 106, and the electronic control system 108 may be internally implanted within a patient's body. In some embodiments, the electronic control system 108 is coupled to or incorporated into the housing of the fluid control system 106. In some embodiments, at least a portion of the electronic control system 108 is physically separate from the fluid control system 106. In some embodiments, some modules of the electronic control system 108 are coupled to or incorporated into the fluid control system 106, and some modules of the electronic control system 108 are separate from the fluid control system 106. For example, in some embodiments, some modules of the electronic control system 108 are included in an external device (such as the external controller 120) that communicates with other modules of the electronic control system 108 included within the implantable device 100. In some embodiments, at least some aspects of the operation of the implantable fluid-actuated inflatable device 100 can be manually controlled.

[0028] In some examples, electronic monitoring and control of fluid-actuated inflatable device 100 may enable improved patient control of the device, improved patient comfort, and improved patient safety. In some examples, electronic monitoring and control of fluid-actuated inflatable device 100 may provide an opportunity for a physician to adjust the operation of inflatable device 100 without further surgical intervention. The fluid architecture that defines the flow and control of fluid through fluid-actuated inflatable device 100, including the configuration and arrangement of fluid components such as pumps, valves, and sensing devices, enables inflatable device 100 to accurately monitor and control its operation, effectively respond to user input, and quickly and effectively adapt to both internal (such as changes in pressure and flow rate) and external (such as pressure surges due to physical activity and impact, sustained pressure changes due to changing atmospheric conditions, and other such external condition changes) changes.

[0029] Example implantable fluid-actuated inflatable device 100 can represent several different types of implantable fluid-actuated devices. For example, device 100 shown in Figure 1 can represent an artificial urinary sphincter 100A, as shown in Figure 2A, an inflatable penile prosthesis 100B, as shown in Figure 2B, and other such implantable inflatable devices that rely on controlled fluid flow to components of the device to achieve inflation, pressurization, deflation, depressurization, deactivation, and the like.

[0030] 2A illustrates a first example system including an example first implantable fluid-actuated inflatable device in the form of an example artificial urinary sphincter 100A. The artificial urinary sphincter 100A includes a fluid control system 106A including fluid components, such as pumps, valves, and sensing devices, disposed within a fluid passageway, and an electronic control system 108A configured to enable transfer of fluid between a reservoir 102A and an inflatable cuff 104A via the fluid components. The fluid components of the fluid control system 106A and the electronic components of the electronic control system 108A can be housed within a housing 110A. A first conduit 103A connects a first fluid port 107A of the fluid control system 106A / electronic control system 108A housed within the housing 110A to the reservoir 102A. A second conduit 105A connects a second fluid port 109A of the fluid control system 106A / electronic control system 108A contained within the housing 110A to the inflatable cuff 104A. The electronic control system 108A of the artificial urinary sphincter 100A can communicate with the external controller 120 via a respective communication module. For example, applications stored in memory and executed by a processor of the external controller 120 can enable a user and / or physician to manipulate, observe, monitor, and modify the operation of the artificial urinary sphincter 100A. In some examples, a power transmission module of the external controller 120 and / or a power transmission device 150 separate from the external controller 120 can charge and / or recharge components of the electronic control system 108A and / or fluid control system 106A.

[0031] FIG. 2B illustrates a second example system including a second example implantable fluid-actuated inflatable device in the form of an example penile prosthesis 100B. Penile prosthesis 100B includes a fluid control system 106B including fluid components, such as pumps, valves, and sensing devices, disposed within a fluid passageway, and an electronic control system 108B configured to enable transfer of fluid between fluid reservoir 102B and inflatable cylinder 104B via the fluid components. The fluid components of fluid control system 106B and the electronic components of electronic control system 108B can be housed within housing 110B. A first conduit 103B connects a first fluid port 107B of fluid control system 106B / electronic control system 108B housed within housing 110B to reservoir 102B. One or more second conduits 105B connect one or more second fluid ports 109B of the fluid control system 106A / electronic control system 108A contained within the housing to the inflatable cylinder 104B. The electronic control system 108A of the penile prosthesis 100B can communicate with the external controller 120 via a respective communication module. For example, applications stored in memory and executed by the processor of the external controller 120 can enable a user and / or physician to operate, observe, monitor, and modify the operation of the penile prosthesis. In some examples, a power transmission module of the external controller 120 and / or a power transmission device 150 separate from the external controller 150 can charge and / or recharge components of the electronic control system 108A and / or fluid control system 106A.

[0032] The principles described herein may be applied to the example implantable fluid-actuated inflatable device shown in Figures 2A and 2B, as well as other types of implantable fluid-actuated inflatable devices that rely on pump assemblies including various fluid components that enable the transfer of fluid between different fluid-filled implantable components to accomplish inflation, deflation, pressurization, depressurization, deactivation, occlusion, etc. The example inflatable devices 100A, 100B shown in Figures 2A and 2B include electronic control systems 108A, 108B that enable control of the operation of the respective inflatable members 104A, 104B, and monitoring and control of the pressure and / or fluid flow through the respective inflatable devices 100A, 100B. Some of the principles described herein may also be applied to manually controlled implantable fluid-actuated inflatable devices.

[0033] As described above, the fluid control system 106 (106A, 106B) may include, for example, a pump assembly including one or more pumps and one or more valves disposed in the fluid circuit of the pump assembly to control the transfer of fluid between the fluid reservoir 102 (102A, 102B) and the inflatable member 104 (104A, 104B). In some examples, the pump(s) and / or valve(s) are electronically controlled. In some examples, the pump(s) and / or valve(s) are manually controlled. In examples where the pump assembly is electronically driven and / or controlled, the pump assembly may include a sealed manifold that can contain and compartmentalize the fluid flow from the pump assembly electronics to prevent leakage and / or gas exchange. In some examples, the pump(s) and / or valve(s) may include piezoelectric elements. In some examples, the pump assembly includes one or more pressure sensing devices within the fluid circuit that enable relatively precise monitoring and control of fluid flow and / or fluid pressure within the fluid circuit and / or inflatable member. A fluid circuit configured in this manner can facilitate proper inflation, deflation, pressurization, depressurization, and deactivation of components of an implantable fluid-actuated device to provide for patient safety and device effectiveness.

[0034] FIG. 3 is a schematic diagram of an example fluidic architecture of an implantable, fluid-actuated, inflatable device according to one embodiment. The fluidic architecture of an implantable, fluid-actuated, inflatable device may include other arrangements of fluid channels, valve(s), pressure sensor(s), and other components other than those shown in FIG. 3. The example fluidic architecture shown in FIG. 3 includes channels that direct fluid flow between the reservoir 102 and the inflatable member 104. In some examples, one or more valves included in the fluidic architecture are normally open valves. A normally open valve is open by default and closes (and remains closed) in response to the application of power. In some examples, one or more valves included in the fluidic architecture can be normally closed valves that are closed by default and open (and remain open) in response to the application of power.

[0035] In the exemplary arrangement shown in FIG. 3 , an active or normally open (NO) valve and first and second pumps are disposed in parallel in each fluid channel between the reservoir 102 and the inflatable member 104. A pressure sensing device disposed in the inflatable member 104 monitors the pressure in the inflatable member 104. During inflation, the pump operates to transfer fluid from the reservoir 102 to the inflatable member 104, inflating the inflatable member 104. During inflation, power is applied to the normally open valve, causing it to close and prevent backflow, i.e., fluid flow back toward the reservoir 102, to maintain a desired pressure in the inflatable member 104. During deflation, power is no longer applied to the normally open valve, causing it to default to its normal open state. When the normally open valve is in its open state, fluid flows from the inflatable member 104 toward the reservoir 102, thereby achieving deflation of the inflatable member 104.

[0036] In some examples, the use of normally open valves can provide a fail-safe in the event of, for example, a power outage or other system failure that causes a loss of control of the pump and / or valve. For example, a loss of power (or other system failure) while the inflatable member 104 is inflated could cause patient discomfort and / or compromise patient safety. Using normally open valves in the fluidic architecture allows fluid to flow from the inflatable member 104 toward the reservoir 102 upon loss of power, thus relieving pressure from the inflatable member 104 and allowing the fluid in the system to reach equilibrium.

[0037] While normally closed valves may not provide these types of fail-safe measures, they may reduce power consumption by the fluid-actuated inflatable device 100. That is, normally closed valves are closed by default and do not rely on the application of power to maintain a closed state. Because many of the valves in a fluidic architecture remain closed for significantly longer periods of time than open (e.g., to maintain the current state of the fluid-actuated inflatable device 100), the use of one or more normally closed valves may allow the fluidic architecture to reduce power consumption (compared to the use of normally open valves). This may result in an extended lifespan of the fluid-actuated inflatable device 100, requiring fewer medical interventions for continued operation (e.g., to replace a power battery), and / or reduced recharging requirements and / or longer intervals between recharges.

[0038] As described above, an example fluid architecture of an implantable fluid-actuated inflatable device according to one embodiment can include one or more pumps and one or more valves that operate to transfer fluid between the reservoir 102 and the inflatable member 104. During a pressurization or inflation operation, the one or more pumps and one or more valves operate to transfer fluid from the reservoir 102 to the inflatable member 104 within a predetermined time to reach a set pressure in the inflatable member 104. During a pressurization or inflation operation, an active valve (a normally open valve in the arrangement shown in FIG. 3 ) remains closed to prevent recirculation of fluid back toward the inlet(s) of the pump(s) and the reservoir 102. During depressurization or deflation from a pressurized or inflated state, the active / normally open valve opens (e.g., in response to a user input) to open a fluid channel, allowing fluid to flow out of the inflatable member 104 and back toward the reservoir 102.

[0039] In some examples, a normally open active valve employs a piezoelectric element acting on a diaphragm. Figures 4A and 4B schematically illustrate the operation of a normally open active valve 400 employing a piezoelectric element or actuator. Specifically, Figure 4A illustrates the normally open active valve 400 in an open state, and Figure 4B illustrates the normally open active valve 400 in a closed state. The principles described herein may likewise be applied to the operation and control of normally closed valves that include piezoelectric actuators, the operation and control of pumps that include piezoelectric actuators, and the operation of pump and valve combinations that include piezoelectric actuators, etc.

[0040] An example normally open active valve 400 shown in FIGS. 4A and 4B includes a piezoelectric element 410 in the form of a disk made of piezoelectric material (e.g., a piezoelectric ceramic disk) attached to a diaphragm 420. In the configuration shown in FIG. 4A, the normally open active valve 400 is in a default, or resting, or open state in which fluid can flow through a chamber 450, i.e., from an inlet to an outlet of the chamber 450. In FIG. 4B, in response to actuation (e.g., application of power to the piezoelectric disk 410), the normally open active valve 400 transitions to a closed state. In the configuration shown in FIG. 4B, application of power to the piezoelectric disk 410 causes a deformation or deflection of the piezoelectric disk 410, which causes a corresponding deformation or deflection of the diaphragm 420. In the deformed state, the deformed piezoelectric disk 410 and diaphragm 420 compress against a sealing element 430 (e.g., an O-ring) to close or seal a fluid channel between the inlet and outlet of the chamber 450. The principles described herein may be similarly applied to the valves and pumps of the fluid architecture of an implantable fluid-actuated inflatable device according to one aspect.

[0041] Figure 5A is a top perspective view and Figure 5B is a cross-sectional view of an example piezoelectric actuator 500 according to one embodiment. The example piezoelectric actuator 500 shown in Figures 5A and 5B can be used in valves and / or pumps of the fluid architecture of an implantable fluid-actuated inflatable device according to one embodiment.

[0042] As shown in FIGS. 5A and 5B , the piezoelectric actuator 500 includes a piezoelectric element 510 in the form of a piezoelectric ring 510 attached to a diaphragm 520. In some examples, an adhesive layer 530 or an epoxy layer 530 is disposed between the piezoelectric ring 510 and the diaphragm 520 to bond the piezoelectric ring 510 onto the diaphragm 520. The piezoelectric ring 510 includes a plate portion 514 having an open portion 512 formed in a central portion thereof. In the example shown in FIGS. 5A and 5B , the plate portion 514 has an annular shape or configuration that surrounds the substantially circular open portion 512 of the piezoelectric ring 510. In the example shown in FIGS. 5A and 5B , the piezoelectric actuator 500, the piezoelectric ring 510 (including the open portion 512 and the plate portion 514), and the diaphragm 520 are substantially circular and are all substantially concentrically arranged for purposes of explanation and illustration only. The principles described herein may also be applied to piezoelectric rings, open portions, plate portions, and diaphragms having other shapes and / or contours and / or shape / contour combinations.

[0043] As discussed above, the piezoelectric ring 510 bends or deforms in response to the application of power or voltage, which in turn causes the diaphragm 520 to bend or deform due to the radial strain imposed on the diaphragm 520 by the bending or deformation or deflection of the piezoelectric ring 510 to which it is attached. Figure 5C shows an upward displacement (in the example orientation shown in Figure 5C) in response to the application of a voltage having a first polarity. Figure 5D shows a downward displacement (in the example orientation shown in Figure 5D) in response to the application of a voltage having a second polarity (opposite the first polarity).

[0044] In a piezoelectric element defined by a piezoelectric disk, as the piezoelectric disk bends and / or deforms in response to the application of a voltage, the center of the piezoelectric disk represents a relatively high stress region of the piezoelectric disk. That is, during bending or deformation of the piezoelectric actuator, the center portion of the piezoelectric disk experiences the highest level of bending or deformation, and therefore the highest level of bending stress during deformation. In contrast, the piezoelectric ring 510 shown in FIGS. 5A-5D includes an open portion 512 defined in the center of the piezoelectric ring 510 that corresponds to this relatively high stress region. In this configuration, as shown, bending or deformation or deflection of the plate portion 514 during bending of the piezoelectric ring 510 causes a corresponding bending or deformation or deflection of the diaphragm 520, but the presence of the open portion 512 in the center of the piezoelectric ring 510 avoids the relatively high stress that would otherwise be experienced in the center (of the piezoelectric disk) during bending / deformation / deflection. By avoiding the high stresses that would otherwise occur in the center of the piezoelectric element during bending / deformation / flexure, the performance and / or durability and / or reliability of the pump or valve in which the piezoelectric actuator 500 is installed can be improved.

[0045] Figure 6 is a top perspective view of an example piezoelectric actuator 600 according to one embodiment. The example piezoelectric actuator 600 shown in Figure 6 can be used in valves and / or pumps of the fluid architecture of an implantable fluid-actuated inflatable device according to one embodiment.

[0046] As shown in FIG. 6 , the piezoelectric actuator 600 includes a piezoelectric element 610 in the form of a piezoelectric ring 610 attached to a diaphragm 620. In some examples, an adhesive layer 630 or an epoxy layer 630 is disposed between the piezoelectric ring 610 and the diaphragm 620 to bond the piezoelectric ring 610 onto the diaphragm 620. The piezoelectric ring 610 includes an open portion 612 at its central portion, and a plate portion 614 of the piezoelectric ring 610 surrounds the open portion 612. In the example shown in FIG. 6 , the plate portion 614 has a substantially annular shape or configuration. In the example shown in FIG. 6 , the piezoelectric actuator 600, the piezoelectric ring 610 (including the open portion 612 and the plate portion 614), and the diaphragm 620 are substantially circular and substantially concentrically arranged for purposes of explanation and illustration only. The principles described herein may also be applied to piezoelectric rings, open portions, plate portions, and diaphragms having other shapes and / or contours and / or shape / contour combinations.

[0047] As described above, the plate portion 614 of the piezoelectric ring 610 bends or deforms in response to the application of power or voltage, which in turn bends or deforms the diaphragm 620. The presence of the open portion 612 in the center of the piezoelectric ring 610 avoids the relatively high stresses that would otherwise be experienced in the center (of the piezoelectric disk) during bending or deformation or deflection, thereby improving the performance and / or durability and / or reliability of the pump or valve in which the piezoelectric actuator 600 is installed.

[0048] 6, piezoelectric ring 610 is separated into segments 610A, 610B, 610C, and 610D. Dividing piezoelectric ring 610 (i.e., plate portion 614 of piezoelectric ring 610 in this example) into individual segments 610A, 610B, 610C, and 610D allows for independent movement of the individual segments 610A, 610B, 610C, and 610D, and independent or separate actuation of each segment 610A, 610B, 610C, and 610D as desired. This allows for flow control through multiple fluid channels with a single piezoelectric actuator, as well as varying degrees of opening / closing of the fluid channels. In some examples, some of the segments 610A, 610B, 610C, and 610D can be selectively actuated to provide flow control, and some of the segments 610A, 610B, 610C, and 610D can be used for sensing (i.e., flow sensing, pressure sensing, etc.). The example arrangement shown in Figure 6 includes four symmetrically arranged segments 610A, 610B, 610C, and 610D of substantially equal size and / or shape for purposes of explanation and illustration only. The principles described herein can also be applied to piezoelectric rings having more or fewer segments, with different shapes and / or combinations of shapes and / or different arrangements of the segments.

[0049] Figure 7A is a side view of an example piezoelectric actuator 700 according to one embodiment, and Figures 7B and 7C are cross-sectional views thereof. The example piezoelectric actuator 700 shown in Figures 7A and 7B can be used in valves and / or pumps of the fluid architecture of an implantable fluid-actuated inflatable device according to one embodiment.

[0050] The example piezoelectric actuator 700 is a cymbal actuator that includes a piezoelectric element 710 disposed between a first plate 740 and a second plate 750. In some examples, the piezoelectric element 710 has a single-layer configuration. In some examples, the piezoelectric element 710 has a multi-layer configuration. One or both of the first plate 740 and the second plate 750 has a convex or bowl-shaped contour extending outward from each side of the piezoelectric element 710 to which it is coupled. In the example shown in FIGS. 7A-7C , the distance between the central portion of the first plate 740 and the piezoelectric element 710 is greater than the distance between the peripheral portion of the first plate 740 and the piezoelectric element 710. Similarly, the distance between the central portion of the second plate 750 and the piezoelectric element 710 is greater than the distance between the peripheral portion of the second plate 750 and the piezoelectric element 710. One or both of the first plate 740 and the second plate 750 can be formed of a deformable, e.g., elastically deformable, material, hi some examples, one or both of the first plate 740 and the second plate 750 are formed of a metallic material.

[0051] The periphery of the piezoelectric element 710 is bonded between the corresponding peripheries of the first and second plates 740, 750. The piezoelectric element 710 can have a variety of different shapes, including, for example, a disk, a square, and other such shapes that allow the periphery of the piezoelectric element to be sandwiched between and bonded to the corresponding peripheries of the first and second plates 740, 750. As shown in FIG. 7C, the piezoelectric actuator 700 can be bonded onto the diaphragm 720, for example, by an epoxy layer 730. Application of a voltage to the piezoelectric element 710 causes the piezoelectric element 710 to expand or contract in a planar direction corresponding to the plane of the piezoelectric element (e.g., in the example orientation shown in FIGS. 7A-7E, horizontally in the direction represented by arrow(s) C shown in FIGS. 7B and 7C). Furthermore, this planar expansion of the piezoelectric element 710 causes the central portions of the first and second plates 740, 750 to move vertically (in the orientation shown in Figures 7A-7E), for example in the direction represented by arrow(s) D shown in Figures 7B and 7C.

[0052] For example, as shown in FIG. 7D , when the piezoelectric element 710 expands, the first end of the piezoelectric element 710 expands in the direction of arrow C1, and the second end of the piezoelectric element 710 expands in the direction of arrow C2. Because the peripheral portions of the piezoelectric element 710 are coupled to the first and second plates 740 and 750, the expansion of the piezoelectric element 710 attracts the central portions of the first and second plates 740 and 750. That is, when the piezoelectric element 710 expands, the corresponding peripheral portions of the coupled first and second plates 740 and 750 move outward. As the peripheral portions of the first and second plates 740 and 750 move outward, the central portion of the first plate 740 moves in the direction of arrow D1, and the central portion of the second plate 750 moves in the direction of arrow D2, thereby bringing the central portions of the first and second plates 740 and 750 closer to each other. Furthermore, this vertical displacement of piezoelectric actuator 700 causes diaphragm 720 to displace, deform, or deflect in the direction of arrow D2 as shown in FIG. 7D.

[0053] Similarly, as shown in FIG. 7E , when the piezoelectric element 710 contracts, the first end of the piezoelectric element 710 contracts in the direction of arrow C2, and the second end of the piezoelectric element 710 contracts in the direction of arrow C1. Because the peripheral edges of the piezoelectric element 710 are coupled to the first and second plates 740, 750, the contraction of the piezoelectric element 710 causes the central portions of the first and second plates 740, 750 to move apart. That is, as the piezoelectric element 710 contracts, the corresponding peripheral edges of the coupled first and second plates 740, 750 move inward. As the peripheral edges of the first and second plates 740, 750 move inward, the central portion of the first plate 740 moves in the direction of arrow D2, and the central portion of the second plate 750 moves in the direction of arrow D1, thereby further separating the central portions of the first and second plates 740, 750. Furthermore, this vertical displacement of piezoelectric actuator 700 causes diaphragm 720 to displace, deform, or deflect in the direction of arrow D1 as shown in FIG. 7E.

[0054] In the example piezoelectric actuator 700 shown in FIGS. 7A-7E, the piezoelectric element 710 may experience some tensile stress in the expanded state shown in FIG. 7D and some compressive stress in the contracted state shown in FIG. 7E. However, because the piezoelectric element 710 is not directly coupled to the diaphragm 720, the piezoelectric element 710 does not experience bending stress when a voltage is applied. This can be an improvement by avoiding bending stress that would otherwise be experienced during bending / deformation / flexure of the diaphragm 720. Furthermore, in some examples, the first and second plates 740, 750 can function as displacement amplifiers. Therefore, the configuration of the first and / or second plates 740, 750 can limit the amount of expansion or contraction of the piezoelectric element 710 required to achieve a desired amount of deformation or deflection of the diaphragm 720, thereby limiting the amount of tensile and / or compressive force experienced by the piezoelectric element 710. This makes it possible to further improve the performance, durability, and / or reliability of the piezoelectric element 710, as well as the performance, durability, and / or reliability of the pump or valve in which the piezoelectric actuator 700 is installed.

[0055] Figure 8A is a top perspective view of an example piezoelectric actuator 800 according to one embodiment. The example piezoelectric actuator 800 shown in Figure 8A can be used in valves and / or pumps of the fluid architecture of an implantable fluid-actuated inflatable device according to one embodiment.

[0056] As shown in FIG. 8A , the piezoelectric actuator 800 includes a multilayered piezoelectric element 810 attached to a diaphragm 820. The multilayered piezoelectric element 810 includes a stack of piezoelectric layers arranged in sequence from a first end to a second end of the multilayered piezoelectric element 810. In the example arrangement shown in FIG. 8A , the multilayered piezoelectric element 810 is attached to the diaphragm 820 by a first support bracket 840 at a first end of the piezoelectric element 810 and by a second support bracket 850 at a second end of the piezoelectric element 810. In some examples, the first and second ends of the piezoelectric element 810 can be bonded to the first and second support brackets 840, 850, respectively, by an epoxy layer 830. The example multilayered piezoelectric element 810 shown in FIG. 8A includes multiple substantially rectangular piezoelectric layers arranged in a stack extending diametrically across the diaphragm 820 for purposes of explanation and illustration only. The principles described herein may also be applied to multi-layer piezoelectric elements that include more or fewer piezoelectric layers, and / or to stacks of piezoelectric layers having different shapes and / or arrangements different from that shown in FIG. 8A.

[0057] First and second ends of the multi-layer piezoelectric element 810 are coupled between first and second support brackets 840, 850 that are attached to the diaphragm 820. In the exemplary arrangement shown in FIG. 8A , the stack of piezoelectric layers forming the multi-layer piezoelectric element 810 is coupled to the first and second support brackets 840, 850 but is not in direct contact with the diaphragm 820. Rather, the portion of the multi-layer piezoelectric element 810 between the first and second ends is spaced from the mounting surface of the diaphragm 820 such that a space 815 is formed between the bottom of the multi-layer piezoelectric element 810 and the mounting surface of the diaphragm 820. Thus, the intermediate portion of the multi-layer piezoelectric element 810 between the first and second ends is movable relative to the diaphragm 820 and is not fixed to the diaphragm 820. When a voltage is applied to the piezoelectric element 810, the piezoelectric element 810 expands or contracts horizontally (in the orientation shown in FIG. 8A), for example, in the direction represented by arrow(s) E shown in FIG. 8A, causing corresponding movement of the first and second support brackets 840, 850 and corresponding vertical displacement (in the orientation shown in FIG. 8A) of the piezoelectric element 810, the first and second support brackets 840, 850 and the diaphragm 820, for example, in the direction represented by arrow(s) F shown in FIG. 8A.

[0058] 8B , when the piezoelectric element 810 expands in the directions of arrows E1 and E2 while the first and second support brackets 840, 850 remain fixed between the piezoelectric element 810 and the diaphragm 820, a pivotal movement of the first support bracket 840 / first end of the piezoelectric element 810 occurs in the direction of arrow G1, and a pivotal movement of the second support bracket 850 / second end of the piezoelectric element 810 occurs in the direction of arrow G2. Thus, in this arrangement, the first support bracket 840 functions as a pivotal attachment that allows the first end of the piezoelectric element 810 to pivot in the direction of arrow G1, and the second support bracket 850 functions as a pivotal attachment that allows the second end of the piezoelectric element 810 to pivot in the direction of arrow G2. Because first and second support brackets 840, 850 are coupled between piezoelectric element 810 and diaphragm 820, this expansion of piezoelectric element 810 due to the application of voltage causes diaphragm 820 to bend, deform, or deflect in the direction of arrow F1, as shown in FIG. 8B.

[0059] 8C , when the first end of piezoelectric element 810 contracts in the direction of arrow E2 and the second end of piezoelectric element 810 contracts in the direction of arrow E1 while first and second support brackets 840, 850 remain fixed between piezoelectric element 810 and diaphragm 820, the first support bracket 840 / first end of piezoelectric element 810 pivots in the direction of arrow G2, and the second support bracket 850 / second end of piezoelectric element 810 pivots in the direction of arrow G1. In this arrangement, first support bracket 840 functions as a pivot that allows the first end of piezoelectric element 810 to pivot in the direction of arrow G2, and second support bracket 850 functions as a pivot that allows the second end of piezoelectric element 810 to pivot in the direction of arrow G1. Because first and second support brackets 840, 850 are coupled between piezoelectric element 810 and diaphragm 820, this contraction of piezoelectric element 810 due to the application of voltage causes diaphragm 820 to bend, deform, or deflect in the direction of arrow F2, as shown in FIG. 8C.

[0060] Figure 9A is a top perspective view and Figure 9B is a cross-sectional view of an example piezoelectric actuator 900 according to one embodiment. The example piezoelectric actuator 900 shown in Figures 9A and 9B can be used in valves and / or pumps of the fluid architecture of an implantable fluid-actuated inflatable device according to one embodiment.

[0061] As shown in Figures 9A and 9B, the piezoelectric actuator 900 includes a piezoelectric element 910 attached to a diaphragm 920. In some examples, an adhesive or epoxy layer 930 is disposed between the piezoelectric element 910 and the diaphragm 920 to bond the piezoelectric element 910 onto the diaphragm 920. In the example arrangements shown in Figures 9A and 9B, the piezoelectric element 910 is substantially circular and in the form of a disk for purposes of explanation and illustration only. Similarly, the diaphragm 920 shown in Figures 9A and 9B is also substantially circular for purposes of explanation and illustration only. The principles described herein may also be applied to piezoelectric elements and / or diaphragms having other shapes and / or configurations.

[0062] 9A and 9B , a piezoelectric element 910 is coupled to a flat portion 922 of a diaphragm 920 within a protrusion 924 or corrugation 924 that surrounds the flat portion 922. The piezoelectric element 910 is therefore contained within the area of ​​the diaphragm 920 that is enclosed within the protrusion 924. The protrusion 924 that surrounds the flat portion 922 of the diaphragm 920 can increase the amount of displacement or deflection of the diaphragm 920 when a given level of voltage is applied to the piezoelectric element 910. This can improve the performance and / or reliability of the piezoelectric actuator 900 and / or the pump or valve in which the piezoelectric actuator 900 is installed. Additionally, the protrusion 924 surrounding the flat portion 922 of the diaphragm 920 can improve alignment of the piezoelectric element 910 on the diaphragm 920 during manufacturing, thereby reducing variability between piezoelectric actuators 900 configured in this manner and further enhancing the performance and / or reliability of the piezoelectric actuator 900 and / or the pump or valve in which the piezoelectric actuator 900 is installed.

[0063] While certain features of the described embodiments have been described herein, many modifications, substitutions, changes and equivalents will occur to those skilled in the art, and it is therefore to be understood that the appended claims are intended to cover all such modifications and variations that fall within the scope of the present embodiments.

Claims

1. 1. An implantable fluid-actuated inflatable device comprising: a fluid reservoir; and an inflatable member; a fluid control system configured to control fluid flow between the fluid reservoir and the inflatable member; The fluid control system comprises: Housing and a fluid architecture defining one or more fluid passageways within the housing; at least one pump and at least one valve disposed within the one or more fluid passages; wherein the at least one pump and the at least one valve comprise piezoelectric actuators operable in response to voltages applied by an electronic control system of the fluid control system, the piezoelectric actuators comprising: a diaphragm mounted within one of the one or more fluid passages defined within the housing to control fluid flow through the fluid passage; a piezoelectric element mounted on the diaphragm and configured to deform in response to a voltage applied by the electronic control system; Including, the diaphragm is configured to deform in response to deformation of the piezoelectric element mounted on the diaphragm; The piezoelectric element is a plate portion mounted on the diaphragm; an open portion within the plate portion; the plate portion surrounds the open portion; a protrusion extending along a peripheral portion of the diaphragm, the contour of the protrusion corresponding to the outer circumferential contour of the plate portion of the piezoelectric element such that the piezoelectric element is contained within an area of ​​the diaphragm surrounded by the protrusion; Implantable fluid-actuated inflatable device.

2. the open portion of the piezoelectric element is defined by a substantially circular opening in a central portion of the piezoelectric element, and the plate portion forms an annular ring surrounding the open portion.

10. The implantable fluid-actuated inflatable device of claim 1.

3. the plate portion includes a plurality of individual segments arranged around the open portion; 10. The implantable fluid-actuated inflatable device of claim 1.

4. a location of the open portion of the piezoelectric element corresponding to a region of high bending stress of the piezoelectric actuator during deformation of the piezoelectric actuator; 10. The implantable fluid-actuated inflatable device of claim 1.

5. each of the plurality of individual segments is individually operable in response to a voltage applied by the electronic control system of the fluid control system; 4. The implantable fluid-actuated inflatable device of claim 3.

6. At least one of the plurality of individual segments is operable to control the flow of the fluid through the fluid passage in response to a voltage applied by the electronic control system of the fluid control system, and at least one of the plurality of individual segments is configured to sense a pressure of the fluid in the fluid passage.

4. The implantable fluid-actuated inflatable device of claim 3.

7. each of the plurality of individual segments having substantially the same size and shape, and the plurality of individual segments being substantially symmetrically disposed about a central plane of the piezoelectric element; 4. The implantable fluid-actuated inflatable device of claim 3.

8. 1. An implantable fluid-actuated inflatable device comprising: a fluid reservoir; and an inflatable member; a fluid control system coupled between the fluid reservoir and the inflatable member and configured to control fluid flow between the fluid reservoir and the inflatable member; The fluid control system comprises: Housing and a fluid control system including a fluid architecture defining one or more fluid passages within the housing; at least one pump and at least one valve disposed within the one or more fluid passages; wherein the at least one pump and the at least one valve comprise piezoelectric actuators operable in response to voltages applied by an electronic control system of the fluid control system, the piezoelectric actuators comprising: a piezoelectric element configured to deform in response to a voltage applied by an electronic control system of the fluid control system; a first plate coupled to a first side of the piezoelectric element, the first plate having a convex contour relative to the first side of the piezoelectric element; a second plate coupled to a second side of the piezoelectric element opposite the first side, the second plate having a convex contour relative to the second side of the piezoelectric element; a diaphragm coupled to the second plate and configured to deform in response to deformation of the piezoelectric element; Including, Implantable fluid-actuated inflatable device.

9. a distance between a central portion of the first plate and the piezoelectric element is greater than a distance between a peripheral portion of the first plate and the piezoelectric element; a distance between a central portion of the second plate and the piezoelectric element is greater than a distance between a peripheral portion of the second plate and the piezoelectric element; 9. The implantable fluid-actuated inflatable device of claim 8.

10. a periphery of the first plate coupled to a periphery of the first side of the piezoelectric element; a periphery of the second plate coupled to a periphery of the second side of the piezoelectric element; the diaphragm is coupled to a central portion of the central portion of the second plate, the second plate being disposed between the diaphragm and the piezoelectric element; 9. The implantable fluid-actuated inflatable device of claim 8.

11. the piezoelectric element is configured to expand in a plane in response to an applied first voltage and contract in a plane in response to an applied second voltage; the first plate and the second plate are configured to deform in response to expansion or contraction of the piezoelectric element.

11. The implantable fluid-actuated inflatable device of claim 10.

12. the first plate is configured to deform in a first direction and the second plate is configured to deform in a second direction opposite the first direction in response to expansion of the piezoelectric element to reduce a distance between the first plate and the second plate; the first plate is configured to deform in the second direction, and the second plate is configured to deform in the first direction in response to contraction of the piezoelectric element to increase the distance between the first plate and the second plate.

12. The implantable fluid-actuated inflatable device of claim 11.

13. the diaphragm is configured to deform in the first direction in response to expansion of the piezoelectric element; the diaphragm is configured to deform in the second direction in response to contraction of the piezoelectric element.

13. The implantable fluid-actuated inflatable device of claim 12.

14. 1. An implantable fluid-actuated inflatable device comprising: a fluid reservoir; and an inflatable member; a fluid control system configured to control fluid flow between the fluid reservoir and the inflatable member; The fluid control system comprises: Housing and a fluid architecture defining one or more fluid passageways within the housing; at least one pump and at least one valve disposed within the one or more fluid passages; wherein the at least one pump and the at least one valve comprise piezoelectric actuators operable in response to voltages applied by an electronic control system of the fluid control system, the piezoelectric actuators comprising: a diaphragm mounted within one of the one or more fluid passages defined within the housing to control fluid flow through the fluid passage; a piezoelectric element mounted on the diaphragm and configured to deform in response to a voltage applied by an electronic control system of the fluid control system; Including, the diaphragm is configured to deform in response to deformation of the piezoelectric element mounted on the diaphragm; The piezoelectric element is a piezoelectric layer stack including a plurality of piezoelectric layers, the plurality of piezoelectric layers being arranged in sequence from a first end to a second end of the piezoelectric layer stack; a first support bracket coupling a first piezoelectric layer at the first end of the stack of piezoelectric layers to a mounting surface of the diaphragm; a second support bracket coupling a second piezoelectric layer at the second end of the stack of piezoelectric layers to a mounting surface of the diaphragm; Including, Implantable fluid-actuated inflatable device.

15. the plurality of piezoelectric layers are arranged in sequence along the mounting surface of the diaphragm from the first end to the second end of the stack of piezoelectric layers; 15. The implantable fluid-actuated inflatable device of claim 14.

16. the stack of piezoelectric layers is configured to expand in response to an applied first voltage; the first end of the stack of piezoelectric layers is configured to pivot in a first pivot direction on the first support bracket in response to expansion of the stack of piezoelectric layers; the second end of the stack of piezoelectric layers is configured to pivot in a second pivot direction on the second support bracket in response to expansion of the stack of piezoelectric layers.

16. The implantable fluid-actuated inflatable device of claim 15.

17. the stack of piezoelectric layers is configured to contract in response to an applied second voltage; the first end of the stack of piezoelectric layers is configured to pivot in a second pivot direction on the first support bracket in response to contraction of the stack of piezoelectric layers; the second end of the stack of piezoelectric layers is configured to pivot in a first pivot direction on the second support bracket in response to contraction of the stack of piezoelectric layers.

17. The implantable fluid-actuated inflatable device of claim 16.

18. the diaphragm is configured to deform in a first direction in response to expansion of the stack of piezoelectric layers; the diaphragm is configured to deform in a second direction in response to contraction of the stack of piezoelectric layers.

18. The implantable fluid-actuated inflatable device of claim 17.

19. a space is formed between a bottom of the piezoelectric element and the mounting surface of the diaphragm, the distance between the bottom of the piezoelectric element and the mounting surface of the diaphragm increasing in response to expansion of the stack of piezoelectric layers and decreasing in response to contraction of the stack of piezoelectric layers; 18. The implantable fluid-actuated inflatable device of claim 17.

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