Fluid control system for an implantable inflatable device - Patents.com

Abstract

The implantable fluid-actuated device can include a fluid reservoir configured to hold a fluid, an expandable member, and an electronic fluid control system for transferring fluid between the fluid reservoir and the expandable member. The fluid control system can include at least one pump or at least one valve including a piezoelectric actuator. The piezoelectric actuator can include a piezoelectric element that deforms in response to a voltage applied by an electronic control system of the fluid control system, and a diaphragm that deforms in response to deformation of the piezoelectric element. An insulating layer can be coupled to the piezoelectric element to insulate the active piezoelectric element from an inactive portion of the piezoelectric actuator.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of and claims priority to U.S. Nonprovisional Patent Application No. 18 / 182,622, entitled "FLUID CONTROL SYSTEM FOR AN IMPLANTABLE INFLATABLE DEVICE," filed March 13, 2023, which claims priority to U.S. Provisional Patent Application No. 63 / 269,438, entitled "FLUID CONTROL SYSTEM FOR AN IMPLANTABLE INFLATABLE DEVICE," filed March 16, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 269,438, filed March 16, 2022, the disclosure of which is incorporated by reference in its entirety herein.

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

[0004] Active implantable fluid-actuated inflatable devices often include one or more pumps that regulate fluid flow between different portions of the implantable device. One or more valves can be positioned within the fluid passages of the device to direct and control fluid flow to achieve inflation, deflation, pressurization, depressurization, activation, and / or shutdown of different fluid-filled implant components of the device. In some implantable fluid-actuated devices, the implantable pumping device may be manually actuated by a user to provide for the transfer of fluid between a reservoir of the device and the fluid-filled implant components. Operation of manually actuated implantable pumping devices may be difficult for some patients. Furthermore, such manual actuation of the pumping device may make it difficult to achieve consistent inflation, deflation, pressurization, depressurization, activation, and / or shutdown of the fluid-filled implant components. Inconsistent inflation, deflation, pressurization, depressurization, activation, and / or shutdown of the fluid-filled implant components may 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 an inflatable device will improve the performance and effectiveness of the device, and will improve 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. In some examples, the fluid control system includes a housing, a fluidics architecture defining one or more fluid passages within the housing, and a piezoelectric actuator for actuating at least one pump or at least one valve positioned in the one or more fluid passages. In some examples, the piezoelectric actuator includes a deformable member mounted in one of the one or more fluid passages defined in the housing to control fluid flow through the fluid passage, a piezoelectric element coupled to the deformable member and configured to deform in response to a voltage applied by an electronic control system of the fluid control system, and an insulating layer positioned between the piezoelectric element and the deformable member and configured to insulate the deformable member from the piezoelectric element.

[0006] In some implementations, the implantable fluid-actuated inflatable device includes a first epoxy layer bonding the insulating layer to the piezoelectric element and a second epoxy layer bonding the insulating layer to the deformable member. In some implementations, the material of the insulating layer is a dielectric material, and the material of at least one of the first epoxy layer or the second epoxy layer is a polymeric material that is treated to remove porosity prior to application. In some implementations, the perimeter dimension of the insulating layer is greater than or equal to the perimeter dimension of the piezoelectric element. In some implementations, the insulating layer includes a mesh or woven material having a set thickness across the insulating layer.

[0007] In some implementations, the piezoelectric element includes at least one electrode on a first side of the piezoelectric element and at least one recess formed on a second side of the piezoelectric element at a location corresponding to the at least one electrode, In some implementations, the insulating layer includes an epoxy layer, and a thickness of the epoxy layer at the locations corresponding to the at least one recess and the at least one electrode is greater than a thickness of a remainder of the epoxy layer.

[0008] In some implementations, the piezoelectric element includes a first cutout portion corresponding to a location of the first electrode relative to the piezoelectric element and a second cutout portion corresponding to a location of the second electrode relative to the piezoelectric element. In some implementations, a thickness of a portion of the insulating layer corresponding to the first cutout portion and a thickness of a portion of the insulating layer corresponding to the second cutout portion are greater than a thickness of a remainder of the insulating layer. In some implementations, the insulating layer includes an epoxy layer, and a material hardness of the epoxy layer matches a material hardness of the piezoelectric element.

[0009] In another general aspect, an implantable fluid-actuated inflatable device includes 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. In some implementations, the fluid control system includes a housing, a fluidics architecture defining one or more fluid passages within the housing, and a piezoelectric actuator that actuates at least one pump and at least one valve positioned in the one or more fluid passages. In some implementations, 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, an actuator foil coupled to the piezoelectric element, and an insulating layer between the piezoelectric element and the actuator foil.

[0010] In some implementations, the insulating layer includes a coating layer deposited on one of the actuator foil or the piezoelectric element, the coating layer including a nano-thick layer of ceramic material deposited on one of the actuator foil or the piezoelectric element, and an epoxy layer between the coating layer and the other of the actuator foil or the piezoelectric element. In some implementations, the insulating layer includes at least one ceramic layer, a first epoxy layer bonding the at least one ceramic layer to the piezoelectric element, and a second epoxy layer bonding the at least one ceramic layer to the actuator foil. In some implementations, the insulating layer includes a plurality of microbeads positioned between the piezoelectric element and the actuator foil and made of an insulating material and having a set size to maintain a set distance between the piezoelectric element and the actuator foil, and an epoxy material applied between the piezoelectric element and the actuator foil and configured to bond the piezoelectric element, the actuator foil, and the plurality of microbeads. In some implementations, the insulating layer includes a mesh material positioned between the piezoelectric element and the actuator foil and fabricated from an insulating material and having a set thickness to maintain a set distance between the piezoelectric element and the actuator foil, and an epoxy material applied between the piezoelectric element and the actuator foil and into openings in the mesh material configured to bond the piezoelectric element, the actuator foil, and the mesh material.

[0011] 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. In some implementations, the fluid control system includes a housing, a fluidics architecture defining one or more fluid passages within the housing, and a piezoelectric actuator for actuating at least one pump and at least one valve positioned in the one or more fluid passages. In some implementations, the piezoelectric actuator includes a deformable member mounted in one of the one or more fluid passages defined in the housing to control fluid flow through the fluid passages, a piezoelectric element coupled to the deformable member and configured to deform in response to a voltage applied by an electronic control system of the fluid control system, and an insulating layer positioned between the piezoelectric element and the deformable member and configured to insulate the deformable member from the piezoelectric element.

[0012] In some implementations, the piezoelectric actuator includes a first epoxy layer bonding the insulating layer to the piezoelectric element and a second epoxy layer bonding the insulating layer to the deformable member. In some implementations, at least one of the first epoxy layer or the second epoxy layer is applied in a pattern including one of a pattern matching an outline of at least one of the piezoelectric element or the deformable member, a linear pattern, a mesh pattern, or a sawtooth pattern. In some implementations, the material of at least one of the first epoxy layer or the second epoxy layer is a polymeric material that has been treated to remove porosity prior to application. In some implementations, the perimeter dimension of the insulating layer is greater than or equal to the perimeter dimension of the piezoelectric element. In some implementations, the insulating layer includes a mesh or woven material having a set thickness across the insulating layer. In some implementations, the insulating layer includes a dielectric material.

[0013] In some implementations, the piezoelectric element includes at least one electrode on a first side of the piezoelectric element and at least one recess formed on a second side of the piezoelectric element at a location corresponding to the at least one electrode. In some implementations, a contour of the at least one recess extends beyond a contour of the at least one electrode. In some implementations, the insulating layer includes an epoxy layer, and a thickness of the epoxy layer at a location corresponding to the at least one recess and the at least one electrode is greater than a thickness of a remainder of the epoxy layer.

[0014] In some implementations, the piezoelectric element includes a first cutout portion corresponding to a location of a first electrode on the piezoelectric element and a second cutout portion corresponding to a location of a second electrode on the piezoelectric element. In some implementations, a thickness of a portion of the insulating layer corresponding to the first cutout portion and a thickness of a portion of the insulating layer corresponding to the second cutout portion are greater than a thickness of a remainder of the insulating layer. In some implementations, the insulating layer includes an epoxy layer, and a material hardness of the epoxy layer matches a material hardness of the piezoelectric element.

[0015] In another general aspect, an implantable fluid-actuated inflatable device includes 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. In some implementations, the fluid control system includes a housing, a fluidics architecture defining one or more fluid passages within the housing, and a piezoelectric actuator that actuates at least one pump or at least one valve positioned in the one or more fluid passages. In some implementations, 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, an actuator foil coupled to the piezoelectric element, and an insulating layer between the piezoelectric element and the actuator foil.

[0016] In some implementations, the insulating layer includes a coating layer deposited on one of the actuator foil or the piezoelectric element, and an epoxy layer between the coating layer and the other of the actuator foil or the piezoelectric element. In some implementations, the coating layer includes a nano-thick layer of ceramic material deposited on one of the actuator foil or the piezoelectric element. In some implementations, the insulating layer includes at least one ceramic layer, a first epoxy layer bonding the at least one ceramic layer to the piezoelectric element, and a second epoxy layer bonding the at least one ceramic layer to the actuator foil. In some implementations, an outer perimeter contour of the at least one ceramic layer is greater than or equal to a corresponding outer perimeter contour of the piezoelectric element. In some implementations, the insulating layer includes a plurality of microbeads positioned between the piezoelectric element and the actuator foil and made of an insulating material and having a set size to maintain a set distance between the piezoelectric element and the actuator foil, and an epoxy material applied between the piezoelectric element and the actuator foil and configured to bond the piezoelectric element, the actuator foil, and the plurality of microbeads. In some implementations, the insulating layer includes a mesh material positioned between the piezoelectric element and the actuator foil and fabricated from an insulating material and having a set thickness to maintain a set distance between the piezoelectric element and the actuator foil, and an epoxy material applied between the piezoelectric element and the actuator foil and into openings in the mesh material configured to bond the piezoelectric element, the actuator foil, and the mesh material. [Brief description of the drawings]

[0017] [Figure 1] FIG. 1 is a block diagram of an implantable fluid-actuated inflatable device according to an embodiment. [Figure 2A] FIG. 1 illustrates a first system including a first exemplary implantable fluid-actuated inflatable device according to an embodiment. [Figure 2B] FIG. 1 illustrates a second system including a second exemplary implantable fluid-actuated inflatable device according to an embodiment. [Figure 3A] FIG. 2 is a schematic diagram of an exemplary active valve in an open state. [Figure 3B] FIG. 3B is a schematic diagram of the example active valve shown in FIG. 3A in a closed state. [Figure 4] FIG. 2 is an exploded view of an exemplary pump actuable by a piezoelectric actuator according to an embodiment. [Figure 5A] FIG. 2 illustrates a top view of an example piezoelectric element, according to an embodiment. [Figure 5B] FIG. 2 is a perspective view of an exemplary actuator foil. [Figure 6A] 1A-1C are schematic diagrams illustrating exemplary piezoelectric elements. [Figure 6B] FIG. 6B is a schematic diagram illustrating the coupling of the exemplary piezoelectric element shown in FIG. 6A to a deformable member. [Figure 6C] 1 illustrates machining of a portion of an example piezoelectric element according to an embodiment. [Figure 6D] FIG. 6D is a schematic diagram illustrating the coupling of the exemplary machined piezoelectric element shown in FIG. 6C to a deformable member. [Figure 7] 1A-1C are schematic diagrams illustrating example piezoelectric elements including insulating coating materials according to an embodiment. [Figure 8A] 1A-1C are schematic diagrams illustrating example piezoelectric elements having insulating ceramic layers bonded thereto, according to an embodiment. [Figure 8B] 1 illustrates an exemplary piezoelectric element having multiple insulating ceramic layers bonded thereto, according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Detailed implementations are discussed in this specification. However, it is understood that the implementations of the present disclosure are merely examples that can be embodied in various forms. Therefore, the specific structural and functional details disclosed in this specification should not be interpreted as limitations, but only as a representative basis for the claims and for teaching those skilled in the art to vary these implementations into virtually any suitable detailed structure. Furthermore, the terms and phrases used in this specification are not limitations, but are intended to provide an understandable description of the present disclosure.

[0019] The terms "a" or "an," as used herein, are defined as one or more than one. The term "another," as used herein, is defined as at least a second or a third or more. The terms "including" and / or "having," as used herein, are defined as comprising (i.e., an open transition). The terms "coupled" or "movably coupled," as used herein, are defined as connected, but not necessarily directly and mechanically.

[0020] In general, the above implementations relate to bodily implants. In this specification, the term patient or user can be used for an individual who can benefit from the medical device or method disclosed in the present disclosure. For example, a patient can be an individual whose body is implanted with the medical device or method of operating the same disclosed by the present disclosure.

[0021] FIG. 1 is a block diagram of an exemplary implantable fluid-actuated inflatable device 100. The exemplary 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 can include fluidic 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 can include one or more sensing devices that sense conditions within the fluidic architecture of the inflatable device 100, such as fluid pressure and fluid flow rate. In some implementations, the inflatable device 100 includes an electronic control system 108. The electronic control system 108 can monitor and / or control the operation of various fluidic components of the fluid control system 106, communicate with one or more sensing devices within the implantable fluid-actuated inflatable device 100, and / or communicate with one or more external devices. In some examples, electronic control system 108 includes components such as a processor, memory, a communications 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 implantable fluid-actuated inflatable device 100. In some examples, the communications module of electronic control system 108 can enable communication with one or more external devices, such as, for example, an external controller 120.

[0022] In some examples, the external controller 120 includes components such as, for example, a user interface, a processor, a memory, a communication 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 executable by the processor of the external controller 120. The external controller 120 can be configured to receive user input, for example, through a user interface, and transmit it to the electronic control system 108, for example, through a communication module, for processing, operation, and control of the inflatable device 100. Similarly, the electronic control system 108 can transmit operation information to the external controller 120 through the respective communication module. This can enable, for example, providing an operation status of the inflatable device 100 to a user through the user interface of the external controller 120, providing diagnostic information to a physician, and the like.

[0023] In some examples, the power transmission module of the external controller 120 allows charging of the components of the internal electronic control system 108. In some examples, power transmission for charging the internal electronic control system 108 may alternatively or additionally be possible from an external power transmission device 150 separate from the external controller 120. In some implementations, the external controller 120 may include sensing devices such as pressure sensors, accelerometers, and other such sensing devices. An external pressure sensor in the external controller 120 may provide, for example, a local ambient pressure or a local operating pressure to the internal electronic control system 108 that allows the inflatable device 100 to compensate for pressure changes. An accelerometer in the external controller 120 may provide detected patient movement to the internal electronic control system 108 for control of the inflatable device 100.

[0024] The fluid reservoir 102, the expandable member 104, the fluid control system 106, and the electronic control system 108 may be implanted within a patient's body. In some implementations, the electronic control system 108 is coupled to or incorporated into a housing of the fluid control system 106. In some implementations, at least a portion of the electronic control system 108 is physically separate from the fluid control system 106. In some implementations, 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 implementations, some modules of the electronic control system 108 are included in an external device (such as the external controller 120) that is in communication with other modules of the electronic control system 108 included in the implantable device 100. In some implementations, at least some aspects of the operation of the implantable fluid-actuated inflatable device 100 may be manually controlled.

[0025] In some examples, electronic monitoring and control of the fluid-actuated inflatable device 100 can allow for improved patient control of the device, improved patient comfort, and improved patient safety. In some examples, electronic monitoring and control of the fluid-actuated device 100 can provide an opportunity for adjustment of the operation of the inflatable device 100 by a physician without further surgical involvement. The fluidics architecture that defines the flow and control of fluid through the fluid-actuated inflatable device 100, including the configuration and arrangement of fluidics components such as pumps, valves, and sensing devices, can enable the inflatable device 100 to precisely monitor and control its operation, to be substantially responsive to user input, and to rapidly and substantially adapt to both state changes within the inflatable device 100 (pressure changes, flow rate changes, and the like) and changing conditions external to the inflatable device 100 (pressure surges due to physical activity and impacts, etc., sustained pressure changes due to changing atmospheric conditions, and other such external condition changes).

[0026] The exemplary implantable fluid-actuated inflatable device 100 can represent a number of different types of implantable fluid-actuated devices. For example, the device 100 shown in Figure 1 can represent an artificial urinary sphincter 100A shown in Figure 2A, an inflatable penile prosthesis 100B shown in Figure 2B, and other such implantable inflatable devices that rely on control of fluid flow to components of the device to achieve inflation, pressurization, deflation, depressurization, deactivation, and the like.

[0027] A first exemplary system including a first exemplary implantable fluid-actuated inflatable device in the form of an exemplary artificial urinary sphincter 100A is shown in FIG. 2A. The artificial urinary sphincter 100A includes a fluid control system 106A including fluidic components such as pumps, valves, and sensing devices positioned in a fluid passageway, and an electronic control system 108A configured to enable the fluidic components to transfer fluid between a reservoir 102A and an inflatable cuff 104A. The fluidic components of the fluid control system 106A and the electronic control system 108A can be received within a housing 110A. A first conduit 103A connects a first fluid port 107A of the fluid control system 106A / electronic control system 108A received within the housing 110A to the reservoir 102A. The second conduit 105A connects a second fluid port 109A of the fluid control system 106A / electronic control system 108A received 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 through 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 activate, observe, monitor, and modify the operation of the artificial urinary sphincter 100A. In some examples, components of the electronic control system 108A and / or the fluid control system 106A can be charged and / or recharged by a power transmission module of the external controller 120 and / or a power transmission device 150 separate from the external controller 120.

[0028] A second exemplary system including a second exemplary implantable fluid-operated inflatable device in the form of an exemplary penile prosthesis 100B is shown in FIG. 2B. The penile prosthesis 100B includes a fluid control system 106B including fluidic components such as pumps, valves, and sensing devices positioned in a fluid passageway, and an electronic control system 108B configured to enable the fluidic components to transfer fluid between the fluid reservoir 102B and the inflatable cylinder 104B. The fluidic components of the fluid control system 106B and the electronic control system 108B can be received in a housing 110B. A first conduit 103B connects a first fluid port 107B of the fluid control system 106B / electronic control system 108B received in the housing 110B to the reservoir 102B. One or more second conduits 105B connect the second one or more second fluid ports 109B of the fluid control system 106A / electronic control system 108A received in the housing to the inflatable cylinder 104B. The electronic control system 108A of the penile prosthesis 100B can communicate with the external controller 120 through the respective communication modules. 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, components of the electronic control system 108A and / or the fluid control system 106A can be charged and / or recharged by a power transmission module of the external controller 120 and / or a power transmission device 150 separate from the external controller 120.

[0029] The principles described herein may be applied to the exemplary 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 a pump assembly including various fluidic components to enable the transfer of fluid between different fluid-filled implantable components to achieve inflation, deflation, pressurization, depressurization, deactivation, occlusion, etc. to achieve effective operation. The exemplary inflatable devices 100A, 100B shown in Figures 2A and 2B include electronic control systems 108A, 108B to enable control of the operation of the respective inflatable members 104A, 104B, and monitoring and control of the pressure of and / or fluid flowing 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.

[0030] As described above, the fluid control system 106 (106A, 106B) can include a pump assembly including, for example, one or more pumps and one or more valves disposed in a 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 pumps and / or valves are electronically controlled. In some examples, the pumps and / or valves are manually controlled. In examples where the pump assembly is electronically powered and / or controlled, the pump assembly can include a sealed manifold that can contain and divide fluid flow from the electronic components of the pump assembly to prevent leakage and / or gas exchange. In some examples, the pumps and / or valves can include piezoelectric elements. In some examples, the pump assembly can include one or more pressure sensing devices in the fluid circuit to enable relatively precise monitoring and control of fluid flow and / or fluid pressure within the fluid circuit and / or the inflatable member. A fluid circuit configured in this manner can facilitate proper inflation, deflation, pressurization, depressurization, and shutdown of an implantable fluid-actuated device to provide patient safety and device efficacy.

[0031] As mentioned above, in some examples, the fluid control system may include one or more pumps and / or one or more valves configured to control fluid flow between the reservoir and the inflatable member of the implantable fluid-controlled inflatable device according to the embodiment. In some examples, the one or more pumps and / or one or more valves may include a piezoelectric actuator that allows for relatively precise electronic control of their operation. That is, the piezoelectric actuator may allow for relatively precise control of opening and closing duration, amount of opening and closing, fluid flow and rate through the fluid passages of the fluid control system, and the like. Figures 3A and 3B show schematic operation of one example of such a valve including a piezoelectric actuator. The principles described herein may be equally applied to any valve including a piezoelectric actuator.

[0032] Figures 3A and 3B generally illustrate the operation and control of a normally open active valve 300 that includes a piezoelectric element or actuator. In particular, Figure 3A illustrates the normally open active valve 300 in an open state, and Figure 3B illustrates the normally open active valve 300 in a closed state. The principles described herein are equally applicable to the operation and control of normally closed valves that include piezoelectric actuators, the operation and control of pumps that include piezoelectric actuators, the operation of pump and valve combinations that include piezoelectric actuators, and the like.

[0033] The exemplary normally open active valve 300 shown in Figures 3A and 3B includes a piezoelectric element 310 in the form of a disk (e.g., a piezoelectric ceramic disk) made of a piezoelectric material and mounted on a diaphragm or membrane 320. In the arrangement shown in Figure 3A, the normally open active valve 300 is in a default, resting, or open state, in which fluid can flow through the chamber 350, i.e., from an inlet to an outlet of the chamber 350. In Figure 3B, the normally open active valve 300 transitions to a closed state in response to actuation (e.g., application of power to the piezoelectric disk 310). In the arrangement shown in Figure 3B, application of power to the piezoelectric disk 310 causes a deformation or deflection of the piezoelectric disk 310 and a corresponding deformation or deflection of the diaphragm 320. In the deformed state, the deformed piezoelectric disk 310 and diaphragm 320 press against a sealing element 330 (e.g., an O-ring, etc.) to close or seal the fluid flow path between the inlet and outlet of the chamber 350. As mentioned above, the principles described herein may also be applied to normally closed valves, as well as other types of valves and pumps in the fluidic architecture of the implantable fluid-actuated inflatable device according to embodiments. In this type of application, the use of piezoelectric actuators may enable improved actuation and control of the pumps and / or valves, improved performance of the implantable fluid-actuated inflatable device in which the pumps and / or valves are provided, and improved patient comfort and safety.

[0034] Figure 4 is an exploded view of an example piezoelectric actuator 400, according to an embodiment. Figure 4 illustrates the use of an example piezoelectric actuator 490 for actuation of a piezoelectric pump 400 for purposes of discussion and illustration only. As mentioned above, the principles described herein are applicable to other devices, such as pumps, valves, and / or pump and valve combinations that can be actuated by a piezoelectric actuator.

[0035] The piezoelectric actuator 400 includes a piezoelectric element 410 mounted on a deformable member such as a membrane or diaphragm 450. In the exemplary arrangement shown in FIG. 4, an insulating layer 430 is bonded between the piezoelectric element 410 and the diaphragm 450. A first epoxy layer 420 bonds the piezoelectric element 410 and the insulating layer 430, and a second epoxy layer 440 bonds the insulating layer 430 and the diaphragm 450. The piezoelectric actuator 400 is operatively coupled to a piezoelectric pump 490 that includes an inlet valve 460 and an outlet valve 470 coupled between the piezoelectric actuator 400 and a base plate 480. In some examples, the piezoelectric actuator may be operatively coupled to a device other than the exemplary pump 490 shown in FIG. 4.

[0036] 4, the insulating layer 430 can provide insulation, e.g., electrical isolation, between the piezoelectric element 410 and the diaphragm 450. For example, the insulating layer 430 can maintain a voltage applied to the piezoelectric element 410 within the piezoelectric element 410 and / or inhibit transmission of the voltage applied to the piezoelectric element 410 to areas outside the piezoelectric element 410. Maintaining the applied voltage within the piezoelectric element 410 and / or inhibiting voltage loss to areas outside the piezoelectric element 410 can improve actuation and control of the piezoelectric element 410 and / or the piezoelectric actuator 400. That is, in the absence of any of these types of losses, a known applied voltage can generate a bending, deformation, and / or deflection of a corresponding piezoelectric element 410 of a known magnitude, amount, and / or direction, and a bending / deformation / deflection of a corresponding diaphragm 450 of a known magnitude / amount / direction. In the situation where any portion of the known applied voltage is diffused, for example, into adjacent areas, the known applied voltage will result in different levels or magnitudes of deformation of the piezoelectric element 410 and the diaphragm 450. Thus, in this regard, the correlation between the known applied voltage and the resulting known deformation of the piezoelectric element 410 and the diaphragm 450 may be compromised, and the operation and control of the piezoelectric actuator 400 and the pump or valve in which it is provided may be adversely affected. It is believed that isolating the voltage to the piezoelectric element 410 may prevent the voltage from leaking into the fluid path of the pump in which the piezoelectric element is provided, which may otherwise adversely affect the patient, cause corrosion of other components of the pump, cause a short circuit or other malfunction of the piezoelectric actuator, etc. In addition, isolating the voltage to the piezoelectric element 410 may inhibit the transmission of the voltage to the patient, thereby improving patient safety and comfort. Isolation of the piezoelectric element 410 may prevent voltage from reaching the bottom plate of the piezoelectric actuator 400 (e.g., through the fluid or by direct contact) which could potentially transmit the voltage to the housing of the actuator 400 where the patient may come into contact. Thus, isolation improves patient safety and comfort, or avoids potential electrochemical interactions with the fluid that could otherwise pose reliability concerns.

[0037] 4 defines a barrier that electrically separates or insulates the piezoelectric element 410 from the remainder of the piezoelectric actuator 400 (e.g., diaphragm 450) despite the physical coupling between the piezoelectric element 410 and the diaphragm 450. The insulating layer can ensure that no electrical communication path exists from the active piezoelectric element 410 to the remaining inactive portions of the piezoelectric actuator 400, and thus, that substantially all of a (known) voltage applied to the piezoelectric element 410 will manifest itself in a known amount or magnitude of deformation of the corresponding piezoelectric element 410 and a known amount or magnitude of deformation of the corresponding diaphragm 450.

[0038] In some examples, the insulating layer 430 can be made of a material that has insulating properties, i.e., a non-conductive material or a material through which electrical current does not flow freely. In some examples, the insulating layer 430 can be made of a single or multi-layer molded polymeric material that provides the desired electrical insulation while at the same time being able to bend, deform, or deflect with the piezoelectric element 410 and the diaphragm 450 and not impede the movement of the piezoelectric element 410 and the diaphragm 450 and / or not adversely affect the operation of the actuator 400 and the pump or valve to which it is provided. In some examples, the insulating layer 430 can be made of one or more layers of woven material that provide the desired electrical insulation while at the same time not moving / impeding the movement of the piezoelectric element 410 and the diaphragm 450. Similarly, the total thickness of the insulating layer 430 can be selected such that the insulating layer 430 provides the desired electrical insulation while at the same time not moving / impeding the movement of the piezoelectric element 410 and the diaphragm 450. In some examples, the insulating layer 430 can include various components, such as electrodes and traces, that provide electrical connections to the piezoelectric element 410 .

[0039] In some examples, the dimensions, e.g., overall dimensions, of the insulating layer 430 are greater than the overall dimensions of the corresponding piezoelectric element 410. For example, the perimeter portion of the insulating layer 430 can extend beyond the perimeter portion of the piezoelectric element 410. In the example shown in FIG. 4, the piezoelectric element 410 is substantially circular for discussion and illustration purposes only. In this example, the overall diameter of the insulating layer 430 can be greater than or equal to the overall diameter of the piezoelectric element 410. The extension of the perimeter portion of the insulating layer 430 greater than the perimeter portion of the piezoelectric element 410 ensures that there is no electrical transmission path from the active piezoelectric element 410 to the remaining non-active portions of the piezoelectric actuator 400, and thus current transmission from the piezoelectric element 410 to the remaining portions of the piezoelectric actuator 400 is inhibited.

[0040] 4, the peripheral portion of the exemplary insulating layer 430 has a sawtooth pattern for purposes of discussion and illustration only. The insulating layer 430 can have other shapes and / or geometries based, for example, on the shape and / or geometry of the piezoelectric element 410, the shape and / or geometry of the diaphragm 450, the associated deformation characteristics of the piezoelectric element 410 and / or the diaphragm 450, and other such factors.

[0041] In some examples, the epoxy material positioned between the piezoelectric element 410 and the diaphragm 450, alone or in conjunction with the insulating layer 430, can provide electrical insulation between the piezoelectric element 410 and the remainder of the piezoelectric actuator 400. In some examples, the material properties, e.g., dielectric material properties, of the first epoxy layer 420 and / or the second epoxy layer 440 can provide electrical insulation and act as an electrical insulator between the active piezoelectric element 410 and the inactive elements of the piezoelectric actuator 400, i.e., the diaphragm 450. In some examples, the dispensing or application pattern of the epoxy layers, such as the first epoxy layer 420 and / or the second epoxy layer 440, can be designed to provide insulation of the electrically active areas of the piezoelectric element 410. In the example shown in FIG. 4, the first epoxy layer 420 and the second epoxy layer 440 are deposited in a relatively large disk format, e.g., corresponding to the size and / or shape of the piezoelectric element 410. In some examples, the epoxy layers, such as, for example, the first epoxy layer 420 and / or the second epoxy layer 440, can be deposited in other types of patterns, such as, for example, a ring pattern, a line pattern, a grid pattern, a sawtooth pattern, a zigzag pattern, and other such patterns that will ensure that the active areas of the piezoelectric elements 410 are insulated by the insulating properties of the epoxy material.

[0042] In some examples, the process associated with the application of the epoxy material can improve the effectiveness of the epoxy material as an insulator (either alone or in combination with the insulating layer 430). For example, the process of removing porosity, entrapped air, or bubbles from the epoxy material prior to application can improve the uniform application of the epoxy material (e.g., the first epoxy layer 420, the second epoxy layer 440, and / or other epoxy layers not specifically shown in FIG. 4) and can improve the insulating characteristics of the epoxy material. In some examples, a vacuum degassing process can be used to remove porosity or entrapped air from the epoxy material prior to application. In some examples, a centrifugation process can be used to remove porosity or entrapped air from the epoxy material prior to application. In some examples, a heating process can be used to remove porosity or entrapped air from the epoxy material prior to application. In some examples, the thickness of the epoxy material (e.g., the first epoxy layer 420, the second epoxy layer 440, and / or other epoxy layers not specifically shown in FIG. 4) can be controlled during the application process to allow for application of a specified thickness range of the epoxy material that will be substantially uniform and provide the desired insulating characteristics.

[0043] Figure 5A is a plan view of a first side 511 of an example actuator foil 510 according to an embodiment, and Figure 5B is a perspective view of a second side 512 of the example actuator foil 510. The example actuator foil 510 shown in Figures 5A and 5B can be used, for example, in a piezoelectric actuator such as the piezoelectric actuator 400 shown in Figure 4 or another piezoelectric actuator to actuate a pump or valve included in a fluid control system of an implantable fluid-actuated inflatable device according to an embodiment.

[0044] As shown in Figures 5A and 5B, the exemplary actuator foil 510 includes a first electrode 551 and a second electrode 552 formed on a first side 511 thereof. A first recess 561 and a second recess 562 are formed on the second side 512. The second side 512 of the exemplary actuator foil 510 may be bonded by an epoxy layer to a non-active portion (not shown in Figures 5A and 5B) of the piezoelectric actuator on which the actuator foil 510 is provided. The location of the first electrode 551 on the first side 511 may correspond to the area encompassed by the first recess 561 on the second side 512. Similarly, the location of the second electrode 552 may correspond to the area encompassed by the second recess 562 on the second side 512. When providing an epoxy for bonding the second side 512 of the actuator foil 510 for bonding to another non-active element, the epoxy can be filled into the recesses 561, 562, thereby increasing the thickness of the epoxy layer in the area of ​​the recesses 561, 562. The greater thickness of the epoxy layer in the area of ​​the recesses 561, 562 provides an additional insulating and / or isolating function in the area of ​​the recesses 561, 562. The positioning of the electrodes 551, 552 of the first side 511 of the actuator foil 510 at positions corresponding to the areas encompassed by the recesses 561, 562 of the second side 512, i.e. provides electrical insulation and / or isolation, particularly in the areas corresponding to the electrodes 551, 552.

[0045] 6A shows an example piezoelectric element 610, and FIG. 6B shows an example piezoelectric element 610 coupled to a non-activated deformable member 650, such as a diaphragm or another non-activated deformable element, by an epoxy layer 620. In the example arrangement shown in FIG. 6B, electrode areas 611, 612, where electrodes are located to selectively actuate the piezoelectric element 610, are insulated from the non-activated deformable member 650 by a thickness t1 of the epoxy layer 620.

[0046] 6C shows an example where material has been removed from a first portion of the piezoelectric element 610 to form a first cutout portion 615 corresponding to the first electrode area 611 and a second cutout portion 616 corresponding to the second electrode area 612. In the example arrangement shown in FIG. 6D, the space between the piezoelectric element 610 and the non-activated deformable member 650 is again filled with an epoxy layer 620. However, in the example arrangement shown in FIG. 6C, the thickness t2 of the epoxy layer 620 in the cutout portions 615, 616 corresponding to the electrode areas 611, 612 is greater than the thickness t1 of the remaining portions of the epoxy layer 620.

[0047] The larger thickness t2 of the epoxy layer 620 in the cutout portions 615, 616 provides a larger insulation distance at the electrode areas 611, 612 and a higher level of electrical insulation at the electrode areas 611, 612. The higher level of electrical insulation at the electrode areas 611, 612 provided by the larger thickness t2 in the cutout portions 615, 616 can further inhibit the transmission of current into the inactive portion of the piezoelectric actuator in which the piezoelectric element 610 is provided. In some examples, the material properties, particularly the material hardness, of the material of the epoxy layer 620 can be matched to the material properties, particularly the material hardness, of the piezoelectric element 610 to enable the cooperative deformation of the piezoelectric element 610, the epoxy layer 620, and the deformable member 650 and to enable adhesion over the larger thickness t2 during deformation. The exemplary piezoelectric element 610 shown in FIG. 6D can be used, for example, to actuate a pump or valve included in a fluid control system of an implantable fluid-actuated inflatable device according to an embodiment in a piezoelectric actuator such as the piezoelectric actuator 400 shown in FIG. 4 or another piezoelectric actuator.

[0048] Figure 7 illustrates a schematic of an example piezoelectric element 710 including an insulating coating material according to an embodiment. The example piezoelectric element 710 illustrated in Figure 7 can be used, for example, in a piezoelectric actuator such as piezoelectric actuator 400 illustrated in Figure 4 or another piezoelectric actuator to actuate a pump or valve included in a fluid control system of an implantable fluid-actuated inflatable device according to an embodiment.

[0049] In the exemplary arrangement shown in FIG. 7, a coating layer 730 is deposited between the piezoelectric element 710 and the actuator foil 740. In some examples, an epoxy layer 720 can be provided between the piezoelectric element 710 and the coating layer 730. The coating layer 730 can include an insulating coating material. In some examples, the coating layer 730 can include a nano-thick layer of a ceramic material. In some examples, the coating layer 730 can be provided using, for example, an evaporation process, an atomic layer deposition (WLD) process, a parylene deposition process, and other such deposition processes. As mentioned above, the insulation provided by the coating layer 730 can prevent voltage leakage into the fluid in the fluid passage of the pump in which the piezoelectric element is provided, which could otherwise adversely affect the patient, cause corrosion of other components of the pump, cause shorting or other malfunction of the piezoelectric actuator, etc. Additionally, isolating the voltage in this manner inhibits the transmission of voltage to the patient, thereby improving patient safety and comfort.

[0050] FIGURE 8A is a schematic diagram of an example piezoelectric element 810 bonded to an insulating ceramic layer according to an embodiment. FIGURE 8B is a schematic diagram of multiple ceramic layers bonded to an example piezoelectric element. The example piezoelectric element 810 shown in FIGURES 8A and 8B can be used, for example, in a piezoelectric actuator such as piezoelectric actuator 400 shown in FIGURE 4 or another piezoelectric actuator to actuate a pump or valve included in a fluid control system of an implantable fluid-actuated inflatable device according to an embodiment.

[0051] In the exemplary arrangement shown in FIG. 8A, a ceramic layer 830 is positioned between the piezoelectric element 810 and the actuator foil 850. The material of the ceramic layer 830 can include insulating properties. In some examples, the ceramic layer 830 is bonded to the piezoelectric element 810 by a first epoxy layer 820 and to the actuator foil 850 by a second epoxy layer 840. Upon curing of the first epoxy layer 820 and the second epoxy layer 840, the ceramic layer 830 between the piezoelectric element 810 and the actuator foil 850 can be bonded to the remaining components of the piezoelectric actuator to which the piezoelectric element 810 is provided prior to bonding of the piezoelectric element 810. In some examples, one or more additional ceramic layers can be bonded to the piezoelectric element 810 to provide additional insulation thickness and provide additional insulation. FIG. 8B illustrates multiple sintered insulating layers of ceramic material that can be bonded to the piezoelectric element 810 to improve the insulation provided by the ceramic layer 830 shown in FIG. 8A. Sintering can allow for compression of the ceramic material within the ceramic layer, providing a higher insulating function in the compressed form. As discussed above, the insulation provided by the ceramic layer can prevent voltage leakage into the fluid passages of the pump in which the piezoelectric element is provided, which could otherwise be transmitted to the patient and adversely affect the patient, cause corrosion of other components of the pump, cause shorting or other malfunction of the piezoelectric actuator, etc.

[0052] In some examples, the insulating material or layer can be positioned between an active portion of the piezoelectric actuator, e.g., a piezoelectric element, and a non-active portion of the piezoelectric actuator, e.g., a deformable member, as shown in Figures 4-6D. In some examples, the insulating material or layer can be positioned between the piezoelectric element and the actuator membrane (film), as shown in Figures 7-8B. In some examples, the insulating material can be in the form of a mesh material. In some examples, the insulating mesh material can provide some means of control of the distance between the elements on either side of it. For example, such an insulating mesh material can maintain a set minimum distance between the piezoelectric element and the actuator foil. Epoxy added within an area of ​​the insulating mesh material can fill the openings defined within the mesh material and provide complete insulation across the face of the layer of insulating mesh material.

[0053] In some examples, the insulating material can include microbeads of insulating material having a known size that can control the distance between the elements on either side of the insulating material, for example, an insulating material including microbeads having a known size can maintain a minimum set distance between the piezoelectric element and the actuator foil, and epoxy is deposited to provide adhesion of adjacent elements, with the microbeads maintaining a set distance between adjacent elements.

[0054] While certain features of the implementations described above have been illustrated as described herein, many modifications, substitutions, variations, and equivalents will now occur to those of ordinary skill in the art, and it is therefore to be understood that the appended claims are intended to cover all such modifications and variations as fall within the embodiments. [Explanation of symbols]

[0055] 100A Artificial Urethral Sphincter 102A Reservoir 103A First Conduit 104A Inflatable cuff 106A Fluid Control System

Claims

1. 1. An implantable fluid-actuated inflatable device, comprising: A fluid reservoir; and an expandable member; a fluid control system configured to control fluid flow between the fluid reservoir and the expandable member; The fluid control system comprises: Housing and a fluidics architecture defining one or more fluid passageways within the housing; a piezoelectric actuator for actuating at least one pump or at least one valve positioned in the one or more fluid passages; The piezoelectric actuator is a deformable member mounted in one of the one or more fluid passages defined in the housing for controlling the flow of fluid therethrough; a piezoelectric element coupled to the deformable member and configured to deform in response to a voltage applied by an electronic control system of the fluid control system; an insulating layer positioned between the piezoelectric element and the deformable member and configured to insulate the deformable member from the piezoelectric element. An implantable fluid-actuated inflatable device.

2. a first epoxy layer bonding the insulating layer to the piezoelectric element; a second epoxy layer bonding the insulating layer to the deformable member; The implantable fluid-actuated inflatable device of claim 1 , further comprising:

3. the material of the insulating layer is a dielectric material; 3. The implantable fluid-actuated expandable device of claim 2, wherein the material of at least one of the first epoxy layer or the second epoxy layer is a polymeric material that has been treated to remove porosity prior to application.

4. The implantable fluid-actuated inflatable device of any one of claims 1 to 3, wherein a perimeter dimension of the insulating layer is greater than or equal to a perimeter dimension of the piezoelectric element.

5. The implantable fluid-actuated inflatable device of any one of claims 1 to 4, wherein the insulating layer comprises a mesh or woven material having a set thickness across the insulating layer.

6. The piezoelectric element is at least one electrode on a first side of the piezoelectric element; at least one recess formed on a second side of the piezoelectric element at a location corresponding to the at least one electrode.

4. An implantable fluid-actuated inflatable device according to claim 1, 2 or 3.

7. the insulating layer includes an epoxy layer; a thickness of the epoxy layer at a position corresponding to the at least one recess and the at least one electrode is greater than a thickness of a remaining portion of the epoxy layer; The implantable fluid-actuated inflatable device of claim 6.

8. The piezoelectric element is a first cutout portion corresponding to a position where a first electrode is disposed relative to the piezoelectric element; and a second cut-out portion corresponding to a location of a second electrode relative to the piezoelectric element.

9. 9. The implantable fluid-actuated inflatable device of claim 8, wherein a thickness of a portion of the insulating layer corresponding to the first cutout portion and a thickness of a portion of the insulating layer corresponding to the second cutout portion are greater than a thickness of the remaining portions of the insulating layer.

10. the insulating layer includes an epoxy layer; the material hardness of the epoxy layer matches the material hardness of the piezoelectric element; 10. The implantable fluid-actuated inflatable device of claim 9.

11. 1. An implantable fluid-actuated inflatable device, comprising: A fluid reservoir; and an expandable member; a fluid control system coupled between the fluid reservoir and the expandable member and configured to control fluid flow between the fluid reservoir and the expandable member; The fluid control system comprises: Housing and a fluidics architecture defining one or more fluid passageways within the housing; a piezoelectric actuator for actuating at least one pump or at least one valve positioned in the one or more fluid passages; The piezoelectric actuator is a piezoelectric element configured to deform in response to a voltage applied by an electronic control system of the fluid control system; an actuator foil coupled to the piezoelectric element; an insulating layer between the piezoelectric element and the actuator foil; An implantable fluid-actuated inflatable device.

12. The insulating layer is a coating layer deposited on one of the actuator foil or the piezoelectric element, the coating layer comprising a nano-thick layer of a ceramic material deposited on the one of the actuator foil or the piezoelectric element; 12. The implantable fluid-actuated inflatable device of claim 11, comprising an epoxy layer between the coating layer and the other of the actuator foil or the piezoelectric element.

13. The insulating layer is at least one ceramic layer; a first epoxy layer bonding the at least one ceramic layer and the piezoelectric element; and a second epoxy layer bonding said at least one ceramic layer and said actuator foil.

14. The insulating layer is a plurality of microbeads positioned between the piezoelectric element and the actuator foil, the microbeads being made of an insulating material and having a set size to maintain a set distance between the piezoelectric element and the actuator foil; an epoxy material applied between the piezoelectric element and the actuator foil, the epoxy material configured to bond the piezoelectric element, the actuator foil, and the plurality of microbeads.

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

15. The insulating layer is a mesh material positioned between the piezoelectric element and the actuator foil, the mesh material being made of an insulating material and having a set thickness to maintain a set distance between the piezoelectric element and the actuator foil; an epoxy material applied between the piezoelectric element and the actuator foil and in the openings in the mesh material, the epoxy material configured to bond the piezoelectric element, the actuator foil, and the mesh material.

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

16. 1. An implantable fluid-actuated inflatable device, comprising: A fluid reservoir; and an expandable member; a fluid control system configured to control fluid flow between the fluid reservoir and the expandable member; The fluid control system comprises: Housing and a fluidics architecture defining one or more fluid passageways within the housing; a piezoelectric actuator for actuating at least one pump or at least one valve positioned in the one or more fluid passages; The piezoelectric actuator is a deformable member mounted in one of the one or more fluid passages defined in the housing for controlling the flow of fluid through the fluid passage; a piezoelectric element coupled to the deformable member and configured to deform in response to a voltage applied by an electronic control system of the fluid control system; an insulating layer positioned between the piezoelectric element and the deformable member and configured to insulate the deformable member from the piezoelectric element. An implantable fluid-actuated inflatable device.

17. a first epoxy layer bonding the insulating layer to the piezoelectric element; a second epoxy layer bonding the insulating layer to the deformable member; 20. The implantable fluid-actuated inflatable device of claim 16, further comprising:

18. 18. The implantable fluid-actuated inflatable device of claim 17, wherein at least one of the first epoxy layer or the second epoxy layer is applied in a pattern including one of a pattern matching a contour of at least one of the piezoelectric element or the deformable member, a linear pattern, a mesh pattern, or a sawtooth pattern.

19. 20. The implantable fluid-actuated expandable device of claim 17, wherein the material of at least one of the first epoxy layer or the second epoxy layer is a polymeric material that has been treated to remove porosity prior to application.

20. 17. The implantable fluid-actuated inflatable device of claim 16, wherein a perimeter dimension of the insulating layer is greater than or equal to a perimeter dimension of the piezoelectric element.

21. The implantable fluid-actuated inflatable device of claim 16 , wherein the insulating layer comprises a mesh or woven material having a set thickness across the insulating layer.

22. The implantable fluid-actuated inflatable device of claim 16 , wherein the insulating layer comprises a dielectric material.

23. The piezoelectric element is at least one electrode on a first side of the piezoelectric element; at least one recess formed on a second side of the piezoelectric element at a location corresponding to the at least one electrode.

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

24. 24. The implantable fluid-actuated inflatable device of claim 23, wherein a contour of the at least one recess extends beyond a contour of the at least one electrode.

25. the insulating layer includes an epoxy layer; a thickness of the epoxy layer at a position corresponding to the at least one recess and the at least one electrode is greater than a thickness of a remaining portion of the epoxy layer; 24. The implantable fluid-actuated inflatable device of claim 23.

26. The piezoelectric element is a first cutout portion corresponding to a position of a first electrode on the piezoelectric element; a second cutout portion corresponding to a position of a second electrode on the piezoelectric element; 17. The implantable fluid-actuated inflatable device of claim 16.

27. 27. The implantable fluid-actuated inflatable device of claim 26, wherein a thickness of a portion of the insulating layer corresponding to the first cutout portion and a thickness of a portion of the insulating layer corresponding to the second cutout portion are greater than a thickness of the remaining portions of the insulating layer.

28. the insulating layer includes an epoxy layer; the material hardness of the epoxy layer matches the material hardness of the piezoelectric element; 28. The implantable fluid-actuated inflatable device of claim 27.

29. 1. An implantable fluid-actuated inflatable device, comprising: A fluid reservoir; and an expandable member; a fluid control system coupled between the fluid reservoir and the expandable member and configured to control fluid flow between the fluid reservoir and the expandable member; The fluid control system comprises: Housing and a fluidics architecture defining one or more fluid passageways within the housing; a piezoelectric actuator for actuating at least one pump or at least one valve positioned in the one or more fluid passages; The piezoelectric actuator is a piezoelectric element configured to deform in response to a voltage applied by an electronic control system of the fluid control system; an actuator foil coupled to the piezoelectric element; an insulating layer between the piezoelectric element and the actuator foil; An implantable fluid-actuated inflatable device.

30. The insulating layer is a coating layer deposited on one of the actuator foil or the piezoelectric element; an epoxy layer between the coating layer and the other of the actuator foil or the piezoelectric element; 30. The implantable fluid-actuated inflatable device of claim 29.

31. 31. The implantable fluid-actuated inflatable device of claim 30, wherein the coating layer comprises a nano-thick layer of a ceramic material deposited on the one of the actuator foil or the piezoelectric element.

32. The insulating layer is at least one ceramic layer; a first epoxy layer bonding the at least one ceramic layer and the piezoelectric element; a second epoxy layer bonding the at least one ceramic layer and the actuator foil.

30. The implantable fluid-actuated inflatable device of claim 29.

33. 33. The implantable fluid-actuated expandable device of claim 32, wherein a perimeter contour of the at least one ceramic layer is greater than or equal to a corresponding perimeter contour of the piezoelectric element.

34. The insulating layer is a plurality of microbeads positioned between the piezoelectric element and the actuator foil, the microbeads being made of an insulating material and having a set size to maintain a set distance between the piezoelectric element and the actuator foil; an epoxy material applied between the piezoelectric element and the actuator foil, the epoxy material configured to bond the piezoelectric element, the actuator foil, and the plurality of microbeads.

30. The implantable fluid-actuated inflatable device of claim 29.

35. The insulating layer is a mesh material positioned between the piezoelectric element and the actuator foil, the mesh material being made of an insulating material and having a set thickness to maintain a set distance between the piezoelectric element and the actuator foil; an epoxy material applied between the piezoelectric element and the actuator foil and in the openings in the mesh material, the epoxy material configured to bond the piezoelectric element, the actuator foil, and the mesh material.

30. The implantable fluid-actuated inflatable device of claim 29.

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