Fluid control system for embedded inflatable devices

Abstract

Precisely operate and control a fluid control system that controls the fluid flow between components of an expandable device. [Solution] An embedded fluid-operated device may include a fluid reservoir configured to hold fluid, an inflatable member, and an electronic fluid control system for transferring fluid between the fluid reservoir and the inflatable member. The fluid control system includes at least one pump and at least one valve, each 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 the electronic control system of the fluid control system. The diaphragm deforms in response to the deformation of the piezoelectric element. The piezoelectric actuator acts at least one pump and at least one valve to control the fluid flow based on either the amount of deformation or the direction of deformation of the diaphragm.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application is a continuation application of and claims priority to U.S. Patent Application No. 18 / 182,612, entitled "Fluid Control System for an Implantable Inflatable Device", filed on 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 on March 16, 2022. The disclosures of these documents are hereby incorporated by reference in their entirety.

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

[0003] The present disclosure generally relates to body implants, and more specifically to body implants including a fluid control system having one or more pumps and / or valves including piezoelectric actuators.

Background Art

[0004] In many cases, active implantable fluid-operated inflatable devices include one or more pumps that regulate fluid flow between different parts of the implantable device. One or more valves can be placed within the fluid passages of the device to guide and control fluid flow to achieve inflation, deflation, pressurization, depressurization, operation, and / or deactivation of different fluid-filled implant components of the device. In some implantable fluid-operated devices, the user can manually operate the implantable pump device to allow fluid transfer between the reservoir and the fluid-filled implant components of the device. Some patients may have difficulty operating manually operated implantable pump devices. Furthermore, manual operation of such pump devices may make it difficult to achieve consistent inflation, deflation, pressurization, depressurization, operation, and / or deactivation of the fluid-filled implant components. Inconsistency in the inflation, deflation, pressurization, depressurization, operation, and / or deactivation of (one or more) fluid-filled implant devices may negatively impact patient comfort, device effectiveness, and overall patient experience. Precisely operating and controlling the fluid control system that manages the fluid flow between components of the inflatable device improves the performance and effectiveness of the device, thereby enhancing patient comfort and safety. [Overview of the Initiative] [Means for solving the problem]

[0005] In a typical embodiment, an embedded fluid-operated inflatable device includes a fluid reservoir, an inflatable member, and a fluid control system configured to control the 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 positioned within the one or more fluid passages, wherein the at least one pump and at least one valve include a piezoelectric actuator that is 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 a voltage applied by the electronic control system. The diaphragm is configured to deform in response to the deformation of the piezoelectric element mounted on the diaphragm. The piezoelectric actuator acts at least one pump and at least one valve to control the fluid flow in one or more fluid passages based on either 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 a 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 high bending stress region 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 the central portion of the piezoelectric element, and the plate portion forms an annular ring surrounding the open portion.

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

[0008] In some embodiments, the piezoelectric actuator includes a projection that extends along the peripheral portion of the diaphragm. The contour of the projection can correspond to the outer circumferential contour of the plate portion of the piezoelectric element, such that the piezoelectric element is housed within the area of ​​the diaphragm surrounded by the projection.

[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 a 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 to 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 may be configured to deform in response to the deformation of the piezoelectric element. The distance between the central portion of the first plate and the diaphragm may be greater than the distance between the peripheral portion of the first plate and the diaphragm, and the distance between the central portion of the second plate and the diaphragm may be greater than the distance between the peripheral portion of the second plate and the diaphragm. The periphery of the first plate can be coupled to the periphery of the first side of the piezoelectric element, the periphery of the second plate can be coupled to the periphery of the second side of the piezoelectric element, the diaphragm can be coupled to the central part of the central part of the second plate, and the second plate can be positioned 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 a first applied voltage and to contract in a planar direction in response to a second applied 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 to 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 a second direction, and the second plate is configured to deform in a first direction in response to the contraction of the piezoelectric element to increase the distance between the first and second plates, the diaphragm is configured to deform in a first direction in response to the expansion of the piezoelectric element, and the diaphragm is configured to deform in a second direction in response to the contraction of the piezoelectric element.

[0011] In some embodiments, the piezoelectric element includes a stack of piezoelectric layers comprising a plurality of piezoelectric layers, wherein the plurality of piezoelectric layers are arranged sequentially from a first end to a second end of the stack of piezoelectric layers along the mounting surface of a diaphragm; a first support bracket coupling the 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 the 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 may be configured to expand in response to an applied first voltage, the first end of the stack of piezoelectric layers may 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 may 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. The stack of piezoelectric layers can be 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 in a 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 a first pivot direction in a second support bracket in response to the contraction of the stack of piezoelectric layers. The diaphragm can be configured to deform in a first direction in response to the expansion of the stack of piezoelectric layers. The diaphragm can be configured to deform in a second direction in response to the contraction of the stack of piezoelectric layers. A space can be formed between the bottom of the piezoelectric element and the mounting surface of the diaphragm, and the distance between the bottom of the piezoelectric element and the mounting surface of the diaphragm can be increased in response to the expansion of the stack of piezoelectric layers and decreased in response to the contraction of the stack of piezoelectric layers.

[0012] In another general embodiment, an embedded fluid-operated inflatable device includes a fluid reservoir, an inflatable member, and a fluid control system configured to control the fluid flow between the fluid reservoir and the inflatable member, wherein 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 that is operable in response to a voltage applied by an electronic control system of the fluid control system. The piezoelectric actuator may include a diaphragm mounted within one or more fluid passages defined within the housing to control the flow of fluid through the fluid passages, and a piezoelectric element mounted on the diaphragm and configured to deform in response to a voltage applied by an electronic control system. The diaphragm may be configured to deform in response to the deformation of the piezoelectric element mounted on the diaphragm. The piezoelectric element may 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 the central portion of the piezoelectric element. A plate portion forms an annular ring surrounding the open portion. The plate portion may 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 the electronic control system of the fluid control system. In some embodiments, at least one of the plurality of individual segments is operable to control the flow of fluid through a 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 the pressure of the fluid in the fluid passage. In some embodiments, each of the plurality of individual segments is substantially the same in size and shape, and the plurality of individual segments are arranged substantially symmetrically around the central plane of the piezoelectric element.

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

[0015] In another general embodiment, an embedded fluid-operated inflatable device may 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 the fluid flow between the fluid reservoir and the inflatable member. The fluid control system may 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, wherein the at least one pump and at least one valve include a piezoelectric actuator that is 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 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 to 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 and configured to deform in response to the 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 periphery of the first plate is coupled to the periphery of the first side of the piezoelectric element, the periphery of the second plate is coupled to the periphery of the second side of the piezoelectric element, the diaphragm is coupled to the central portion of the central portion of the second plate, and the second plate is positioned between the diaphragm and the piezoelectric element. The piezoelectric element can be configured to expand in the planar direction in response to an applied first voltage and to contract in the planar direction in response to an applied second voltage. The first and second plates 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 to the first direction in response to the expansion of the piezoelectric element, thereby decreasing the distance between the first and second plates. In some embodiments, the first plate is configured to deform in a second direction, and the second plate is configured to deform in a first direction in response to the contraction of the piezoelectric element, thereby increasing the distance between the first and second plates. The diaphragm can be configured to deform in a first direction in response to the expansion of the piezoelectric element, and the diaphragm can be configured to deform in a second direction in response to the contraction of the piezoelectric element.

[0018] In another general embodiment, an embedded fluid-operated inflatable device may include a fluid reservoir, an inflatable member, and a fluid control system configured to control the fluid flow between the fluid reservoir and the inflatable member. The fluid control system may 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 one or more fluid passages, wherein the at least one pump and at least one valve include a piezoelectric actuator that is operable in response to a voltage applied by the electronic control system of the fluid control system. The piezoelectric actuator may include a diaphragm mounted in 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 may be configured to deform in response to the deformation of the piezoelectric element mounted on the diaphragm. The piezoelectric element may include a stack of piezoelectric layers comprising a plurality of piezoelectric layers, wherein the plurality of piezoelectric layers are arranged sequentially from a first end to a second end of the stack of piezoelectric layers; a first support bracket that connects the first piezoelectric layer at the first end of the stack of piezoelectric layers to the mounting surface of a diaphragm; and a second support bracket that connects the second piezoelectric layer at the second end of the stack of piezoelectric layers to the mounting surface of a diaphragm.

[0019] In some embodiments, multiple piezoelectric layers can be arranged sequentially along the mounting surface of the diaphragm from a first end to a second end of a 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 a 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 a second support bracket in response to the expansion of the stack of piezoelectric layers. In some embodiments, the stack of piezoelectric layers can be 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 a 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 a first pivot direction at a 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 piezoelectric layer stack, and to deform in a second direction in response to contraction of the piezoelectric layer stack. In some embodiments, a space is formed between the bottom of the piezoelectric element and the 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 piezoelectric layer stack and decreases in response to contraction of the piezoelectric layer stack. [Brief explanation of the drawing]

[0020] [Figure 1] This is a block diagram of an embedded, fluid-operated, expandable device according to one embodiment. [Figure 2A] This figure shows a first system including an example of a first embedded fluid-operated inflatable device according to one embodiment. [Figure 2B] This figure shows a second system including a second embedded fluid-operated expandable device according to one embodiment. [Figure 3] This is a schematic diagram of the fluid architecture of an embedded fluid-operated expandable device according to one embodiment. [Figure 4A]Schematic diagram of an example of an active valve in an open state. [Figure 4B] Schematic diagram of an example of the active valve shown in Fig. 4A in a closed state. [Figure 5A] Top perspective view of an example of a piezoelectric actuator according to one aspect. [Figure 5B] Cross-sectional view of an example of the piezoelectric actuator shown in Fig. 5A taken along line A-A of Fig. 5A. [Figure 5C] Diagram showing an example of the piezoelectric actuator shown in Figs. 5A and 5B in a first operating state. [Figure 5D] Diagram showing an example of the piezoelectric actuator shown in Figs. 5A and 5B in a second operating state. [Figure 6] Top perspective view of an example of a piezoelectric actuator according to one aspect. [Figure 7A] Side view of an example of a piezoelectric actuator according to one aspect. [Figure 7B] Cross-sectional view of an example of the piezoelectric actuator shown in Fig. 7A taken along line B-B of Fig. 5A. [Figure 7C] Cross-sectional view of an example of the piezoelectric actuator shown in Fig. 7A coupled to a diaphragm. [Figure 7D] Diagram showing an example of the piezoelectric actuator shown in Figs. 7A to 7C in a first operating state. [Figure 7E] Diagram showing an example of the piezoelectric actuator shown in Figs. 7A to 7C in a second operating state. [Figure 8A] Top perspective view of an example of a piezoelectric actuator according to one aspect. [Figure 8B] Diagram showing an example of the piezoelectric actuator shown in Fig. 8A in a first operating state. [Figure 8C] Diagram showing an example of the piezoelectric actuator shown in Fig. 8A in a second operating state. [Figure 9A] Top perspective view of an example of a piezoelectric actuator according to one aspect. [Figure 9B] Cross-sectional view of an example of the piezoelectric actuator shown in Fig. 9A taken along line H-H of Fig. 9A. [Modes for carrying out the invention]

[0021] This specification discloses detailed embodiments. However, the disclosed embodiments are merely examples and should be understood as being able to be embodied in various forms. Accordingly, the specific structural and functional details disclosed herein should be interpreted not as limitations, but merely as the basis for the claims and as representative grounds to teach those skilled in the art that these embodiments can be adopted in various ways in substantially any suitable detailed structure. Furthermore, the terms and expressions used herein are not intended to be limiting, but are intended to provide an understandable description of this disclosure.

[0022] As used herein, the term “one” is defined as one or more. As used herein, the term “another” is defined as at least two or more. As used herein, the terms “including” and / or “having” are defined as comprising (i.e., open transition). As used herein, the terms “coupled” or “moveably coupled” are defined as connected, but not necessarily direct and mechanical.

[0023] Generally, embodiments relate to bodily implants. Hereinafter, the terms patient or user may be used to refer to a person who benefits from the medical device or method disclosed herein. For example, a patient may be a person in whom the disclosed medical device or the method of operation of the medical device according to this disclosure is implanted in the body.

[0024] Figure 1 is a block diagram of an example 100 of an embedded fluid-operated inflatable device. The example device 100 shown in Figure 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 detect 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 can 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 embedded fluid-operated 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 the operation and control of the embedded fluid-operated 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, processor, memory, communication module, power transmission module, and other such components that enable the 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 and applications that the processor of the external controller 120 can execute. The external controller 120 can be configured to receive user input via the user interface and the like, and to transmit user input to the electronic control system 108 via the communication module and the like 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 via its respective communication module. As a result, the operating status of the inflatable device 100 can be provided to the user via the user interface of the external controller 120, or diagnostic information can be provided to a doctor.

[0026] In some examples, the power transmission module of the external controller 120 enables charging of components of the internal electronic control system 108. In some examples, alternatively or in addition to this, a separate external power transmission device 150 may transmit power to charge the internal electronic control system 108, separate from the external controller 120. In some embodiments, 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 the internal electronic control system 108 with, for example, local atmospheric pressure or operating pressure so that the inflatable device 100 can compensate for pressure fluctuations. An accelerometer in the external controller 120 may provide the internal electronic control system 108 with detected patient movement 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 can be implanted internally in the 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 separated 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 separated 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 an external controller 120) that communicates with other modules of the electronic control system 108 contained within the implantable device 100. In some embodiments, at least some aspects of the operation of the implantable fluid-operated inflatable device 100 can be manually controlled.

[0028] In some cases, electronic monitoring and control of the fluid-operated inflatable device 100 can enable improved patient control of the device, improved patient comfort, and improved patient safety. In some cases, electronic monitoring and control of the fluid-operated inflatable device 100 can provide physicians with the opportunity to adjust the operation of the inflatable device 100 without further surgical intervention. The fluid architecture, which defines the fluid flow and control through the fluid-operated inflatable device 100, including the configuration and arrangement of fluid components such as pumps, valves, and sensing devices, enables the inflatable device 100 to accurately monitor and control its own operation, respond effectively to user input, and quickly and effectively adapt to both internal and external changes (such as changes in pressure and flow rate) and external changes (such as pressure surges caused by physical activity and impacts, sustained pressure changes caused by changes in atmospheric conditions, and other such external changes).

[0029] The implantable fluid-operated inflatable device example 100 can represent several different types of implantable fluid-operated devices. For example, the device 100 shown in Figure 1 can represent an artificial urethral sphincter 100A as shown in Figure 2A, an inflatable penile prosthesis 100B as shown in Figure 2B, and other such implantable inflatable devices that achieve inflation, pressurization, deflation, depressurization, and deactivation by relying on the control of fluid flow to the device's components.

[0030] Figure 2A shows a first system example including a first implantable fluid-operated inflatable device in the form of an artificial urethral sphincter example 100A. The artificial urethral sphincter 100A includes a fluid control system 106A which includes fluid components such as a pump, valves and a sensing device located in the fluid passage, and an electronic control system 108A configured to enable the 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 in a housing 110A. A first conduit 103A connects a first fluid port 107A of the fluid control system 106A / electronic control system 108A housed in the housing 110A to a reservoir 102A. The second conduit 105A connects the second fluid port 109A of the fluid control system 106A / electronic control system 108A, housed within the housing 110A, to the inflatable cuff 104A. The electronic control system 108A of the artificial urethral sphincter 100A can communicate with the external controller 120 via its respective communication module. For example, an application stored in memory and executed by the processor of the external controller 120 can enable the user and / or physician to operate, observe, monitor, and modify the operation of the artificial urethral sphincter 100A. In some examples, the power transmission module of the external controller 120 and / or a power transmission device 150 separated from the external controller 120 can charge and / or recharge the components of the electronic control system 108A and / or the fluid control system 106A.

[0031] Figure 2B shows a second system example, including a second implantable fluid-operated inflatable device example in the form of penile prosthesis example 100B. Penile prosthesis 100B includes a fluid control system 106B, which includes fluid components such as a pump, valves, and a sensing device located in a fluid passage, and an electronic control system 108B configured to enable the transfer of fluid between a fluid reservoir 102B and an inflatable cylinder 104B via the fluid components. The fluid components of the fluid control system 106B and the electronic components of the electronic control system 108B can be housed in a housing 110B. A first conduit 103B connects a first fluid port 107B of the fluid control system 106B / electronic control system 108B, housed in the housing 110B, to the 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, housed within the housing, to the inflatable cylinder 104B. The electronic control system 108A of the penile prosthesis 100B can communicate with an external controller 120 via its respective communication module. For example, an application stored in memory and executed by the processor of the external controller 120 can enable the 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 separated from the external controller 150 can charge and / or recharge the components of the electronic control system 108A and / or the fluid control system 106A.

[0032] The principles described herein can be applied to embedded fluid-operated inflatable devices, as shown in Figures 2A and 2B, and to other types of embedded fluid-operated inflatable devices that achieve expansion, contraction, pressurization, depressurization, deactivation, and occlusion by relying on a pump assembly containing various fluid components that enable the transfer of fluid between different fluid-filled embedded components for effective operation. The inflatable device examples 100A and 100B shown in Figures 2A and 2B include electronic control systems 108A and 108B that enable control of the operation of the respective inflatable members 104A and 104B, and monitoring and control of the pressure and / or fluid flow through the respective inflatable devices 100A and 100B. Some of the principles described herein can also be applied to manually controlled embedded fluid-operated inflatable devices.

[0033] As described above, the fluid control system 106 (106A, 106B) may include a pump assembly that includes one or more pumps and one or more valves, which are located, for example, in the fluid circuit of a pump assembly to control the transfer fluid between the fluid reservoir 102 (102A, 102B) and the expandable member 104 (104A, 104B). In some examples, the (one or multiple) pumps and / or the (one or multiple) valves are electronically controlled. In some examples, the (one or multiple) pumps and / or the (one or multiple) valves 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 the fluid flow and isolate it from the electronic components of the pump assembly to prevent leakage and / or gas exchange. In some examples, the (one or multiple) pumps and / or the (one or multiple) valves may include piezoelectric elements. In some examples, the pump assembly includes one or more pressure sensing devices within the fluid circuit, enabling relatively accurate monitoring and control of fluid flow and / or fluid pressure within the fluid circuit and / or inflatable members. A fluid circuit configured in this way can facilitate the correct inflation, deflation, pressurization, depressurization, and deactivation of components of an embedded fluid-operated device, thereby providing patient safety and device effectiveness.

[0034] Figure 3 is a schematic diagram of an example fluid architecture of an embedded fluid-operated inflatable device according to one embodiment. The fluid architecture of an embedded fluid-operated inflatable device may also include other arrangements of fluid channels, (one or more) valves, (one or more) pressure sensors, and other components other than those shown in Figure 3. The example fluid architecture shown in Figure 3 includes channels that guide fluid flow between the reservoir 102 and the inflatable member 104. In some examples, one or more valves included in the fluid architecture are normally open valves. Normally open valves are open by default and close (and remain closed) in response to the application of power. In some examples, one or more valves included in the fluid architecture may be normally closed valves that are closed by default and open (and remain open) in response to the application of power.

[0035] In the configuration example shown in Figure 3, an active valve or a normally open (NO) valve and first and second pumps are arranged in parallel within the fluid channel between the reservoir 102 and the expandable member 104. A pressure sensing device located on the expandable member 104 monitors the pressure of the expandable member 104. During expansion, the pumps operate to transfer fluid from the reservoir 102 to the expandable member 104, causing it to expand. During expansion, power is supplied to the normally open valve, which closes, preventing backflow, i.e., the flow of fluid back towards the reservoir 102, and maintaining the desired pressure in the expandable member 104. During contraction, power is no longer supplied to the normally open valve, and it returns to its default, normally open state. When the normally open valve is open, fluid flows from the expandable member 104 towards the reservoir 102, achieving contraction of the expandable member 104.

[0036] In some cases, the use of normally open valves can provide a fail-safe measure in the event of a power outage or other system failure that causes, for example, loss of control of the pump and / or valves. For example, if a power outage (or other system failure) occurs while the expandable member 104 is expanded, the patient may experience discomfort and / or the patient's safety may be compromised. When a normally open valve is used in a fluid architecture, fluid flows from the expandable member 104 to the reservoir 102 in the event of a power outage, so that the pressure is released from the expandable member 104 and the fluid in the system reaches equilibrium.

[0037] While normally closed valves may not provide these types of fail-safe mechanisms, they can reduce the power consumption of the fluid-operated inflatable device 100. That is, normally closed valves are closed by default and do not rely on power supply to maintain the closed state. Since many valves in a fluid architecture remain closed for significantly longer periods than they would be open (e.g., to maintain the current state of the fluid-operated inflatable device 100), using one or more normally closed valves allows the fluid architecture to reduce power consumption (compared to the use of normally open valves). As a result, the lifespan of the fluid-operated inflatable device 100 is extended, the medical intervention required for continued operation (e.g., to replace the power battery) is reduced, and / or recharging requirements are lowered, and / or recharging intervals can be extended.

[0038] As described above, one example of the fluid architecture of an embedded fluid-operated inflatable device may 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 pressurization or expansion, one or more pumps and one or more valves operate to transfer fluid from the reservoir 102 to the inflatable member within a predetermined time to reach a set pressure in the inflatable member 104. During pressurization or expansion, the active valve (a normally open valve in the arrangement shown in Figure 3) remains closed to prevent recirculation of fluid returning to the inlets of the (one or multiple) pumps and the reservoir 102. In the event of depressurization or deflation from the pressurized or expanded state, the active / normally open valve opens (for example, in response to user input) to open the fluid channel, allowing fluid to flow out of the inflatable member 104 and return to the reservoir 102.

[0039] In some examples, normally open active valves employ a piezoelectric element that acts on a diaphragm. Figures 4A and 4B schematically show the operation of a normally open active valve 400 employing a piezoelectric element or piezoelectric actuator. Specifically, Figure 4A shows the open state of the normally open active valve 400, and Figure 4B shows the closed state of the normally open active valve 400. The principles described herein can also be applied to the operation and control of normally closed valves including piezoelectric actuators, the operation and control of pumps including piezoelectric actuators, and the operation of combinations of pumps and valves including piezoelectric actuators.

[0040] The normally open active valve example 400 shown in Figures 4A and 4B includes a piezoelectric element 410 in the form of a disc made of piezoelectric material (e.g., a piezoelectric ceramic disc) mounted on a diaphragm 420. In the arrangement shown in Figure 4A, the normally open active valve 400 is in a default state, stationary state, or open state, allowing fluid to flow through the chamber 450, i.e., from the inlet to the outlet of the chamber 450. In Figure 4B, the normally open active valve 400 transitions to a closed state in response to operation (e.g., power application to the piezoelectric disc 410). In the arrangement shown in Figure 4B, power application to the piezoelectric disc 410 causes deformation or deflection of the piezoelectric disc 410, and the corresponding deformation or deflection of the diaphragm 420. In the deformed state, the deformed piezoelectric disc 410 and diaphragm 420 compress a sealing element 430 (e.g., an O-ring) to close or seal the fluid channel between the inlet and outlet of the chamber 450. The principles described herein can also be applied to valves and pumps in the fluid architecture of an embedded fluid-operated expandable device according to one embodiment.

[0041] Figure 5A is a top perspective view of an example piezoelectric actuator 500 according to one embodiment, and Figure 5B is a cross-sectional view thereof. The example piezoelectric actuator 500 shown in Figures 5A and 5B can be used in a valve and / or pump of a fluid architecture of an embedded fluid-operated expandable device according to one embodiment.

[0042] As shown in Figures 5A and 5B, the piezoelectric actuator 500 includes a piezoelectric element 510 in the form of a piezoelectric ring 510 mounted on a diaphragm 520. In some examples, an adhesive layer 530 or epoxy layer 530 is placed between the piezoelectric ring 510 and the diaphragm 520 to bond the piezoelectric ring 510 to the diaphragm 520. The piezoelectric ring 510 includes a plate portion 514 having an open portion 512 formed in its central part. In the examples shown in Figures 5A and 5B, the plate portion 514 has an annular shape or configuration surrounding the substantially circular open portion 512 of the piezoelectric ring 510. In the examples shown in Figures 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 concentric for illustrative purposes only. The principles described herein can also be applied to piezoelectric rings, open portions, plate portions, and diaphragms having other shapes and / or contours and / or combinations of shapes / contours.

[0043] As described above, the piezoelectric ring 510 bends or deforms in response to the application of power or voltage, and therefore the diaphragm 520 also bends or deforms due to the radial strain applied to the diaphragm 520 by the bending, deformation, or deflection of the piezoelectric ring 510 to which it is attached. Figure 5C shows the upward displacement (in the orientation example shown in Figure 5C) in response to the application of a voltage having a first polarity. Figure 5D shows the downward displacement (in the orientation example shown in Figure 5D) in response to the application of a voltage having a second polarity (opposite to 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 voltage, the central part of the piezoelectric disk comes to represent a relatively high stress region. That is, during the bending or deformation of the piezoelectric actuator, the central part 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 Figures 5A to 5D includes an open portion 512 defined in the center of the piezoelectric ring 510 that corresponds to this relatively high stress region. With this configuration, as shown in the figures, when the piezoelectric ring 510 is bent, the bending, deformation or deflection of the plate portion 514 causes bending, deformation or deflection corresponding to the diaphragm 520. However, the presence of the open portion 512 in the center of the piezoelectric ring 510 makes it possible to avoid the relatively high stress that would have occurred in the central part (of the piezoelectric disk) during bending / deformation / deflection. By avoiding the high stress that would otherwise occur in the center of the piezoelectric element during bending / deformation / flexing, 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 a piezoelectric actuator example 600 according to one embodiment. The piezoelectric actuator example 600 shown in Figure 6 can be used in a valve and / or pump of a fluid architecture of an embedded fluid-operated expandable device according to one embodiment.

[0046] As shown in Figure 6, the piezoelectric actuator 600 includes a piezoelectric element 610 in the form of a piezoelectric ring 610 mounted on a diaphragm 620. In some examples, an adhesive layer 630 or epoxy layer 630 is placed between the piezoelectric ring 610 and the diaphragm 620 to bond the piezoelectric ring 610 to the diaphragm 620. The piezoelectric ring 610 includes an open portion 612 in its central part, and a plate portion 614 of the piezoelectric ring 610 surrounds the open portion 612. In the example shown in Figure 6, the plate portion 614 has a substantially annular shape or configuration. In the example shown in Figure 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 illustrative purposes only. The principles described herein can also be applied to piezoelectric rings, open portions, plate portions, and diaphragms having other shapes and / or contours and / or combinations of shapes / contours.

[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, and the diaphragm 620 also bends or deforms as a result. The presence of an open portion 612 in the center of the piezoelectric ring 610 avoids the relatively high stress that would otherwise occur in the center (of the piezoelectric disk) during bending, deformation, or deflection, and thus improves the performance and / or durability and / or reliability of the pump or valve in which the piezoelectric actuator 600 is installed.

[0048] In the example configuration shown in Figure 6, the piezoelectric ring 610 is separated into segments 610A, 610B, 610C, and 610D. By dividing the piezoelectric ring 610 (i.e., the plate portion 614 of the piezoelectric ring 610 in this example) into individual segments 610A, 610B, 610C, and 610D, independent movement of the individual segments 610A, 610B, 610C, and 610D is possible, as well as independent or individual operation of each segment 610A, 610B, 610C, and 610D as needed. As a result, flow rate control through multiple fluid channels can be performed with a single piezoelectric actuator, and various degrees of opening / closing of the fluid channels can be enabled. In some examples, some of segments 610A, 610B, 610C, and 610D can be selectively activated to control the flow rate, and some of segments 610A, 610B, 610C, and 610D can be used for sensing (i.e., sensing flow rate and sensing pressure, etc.). The example arrangement shown in Figure 6 includes, for illustrative purposes only, four symmetrically arranged segments 610A, 610B, 610C, and 610D that are substantially equal in size and / or shape. The principles described herein can also be applied to piezoelectric rings having more or fewer segments, or having segments of different shapes and / or combinations of shapes, and / or different arrangements.

[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 a valve and / or pump of a fluid architecture of an embedded fluid-operated expandable device according to one embodiment.

[0050] Example 700 of the piezoelectric actuator is a cymbal actuator that includes a piezoelectric element 710 positioned 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 have a convex or bowl-shaped contour extending outward from each side of the piezoelectric element 710 to which they are coupled. In the examples shown in Figures 7A to 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 from a deformable, for example, elastically deformable material. In some examples, one or both of the first plate 740 and the second plate 750 are formed from a metallic material.

[0051] The periphery of the piezoelectric element 710 is coupled between the corresponding peripheries of the first and second plates 740, 750. The piezoelectric element 710 can have various different shapes, including disc-shaped, square, and other such shapes, which allow the periphery of the piezoelectric element to be sandwiched and coupled between the corresponding peripheries of the first and second plates 740, 750. As shown in Figure 7C, the piezoelectric actuator 700 can be coupled to the diaphragm 720 by, for example, an epoxy layer 730. When a voltage is applied to the piezoelectric element 710, the piezoelectric element 710 expands or contracts in a planar direction corresponding to the plane of the piezoelectric element (for example, horizontally in the direction indicated by the (single and double) arrows C shown in Figures 7B and 7C in the orientation examples shown in Figures 7A to 7E). Furthermore, the planar expansion of the piezoelectric element 710 moves the central portions of the first and second plates 740 and 750 vertically (in the orientation examples shown in Figures 7A to 7E) in the direction represented by the (single and double) arrows D shown in Figures 7B and 7C.

[0052] For example, as shown in Figure 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 portion of the piezoelectric element 710 is coupled to the first and second plates 740 and 750, the expansion of the piezoelectric element 710 causes the central portions of the first and second plates 740 and 750 to be pulled closer together. That is, when the piezoelectric element 710 expands, the corresponding peripheral portions of the first and second plates 740 and 750 coupled to it move outward. When 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, so that the central portions of the first and second plates 740 and 750 move closer to each other. Furthermore, the vertical displacement of the piezoelectric actuator 700 causes the diaphragm 720 to be displaced, deformed, or deflected in the direction of arrow D2, as shown in Figure 7D.

[0053] Similarly, as shown in Figure 7E, when the piezoelectric element 710 shrinks, the first end of the piezoelectric element 710 shrinks in the direction of arrow C2, and the second end of the piezoelectric element 710 shrinks in the direction of arrow C1. Because the peripheral portion of the piezoelectric element 710 is coupled to the first and second plates 740 and 750, the shrinking of the piezoelectric element 710 causes the central portions of the first and second plates 740 and 750 to separate. That is, when the piezoelectric element 710 shrinks, the corresponding peripheral portions of the first and second plates 740 and 750 coupled to it move inward. When the peripheral portions of the first and second plates 740 and 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, and thus the central portions of the first and second plates 740 and 750 separate further. Furthermore, the vertical displacement of the piezoelectric actuator 700 causes the diaphragm 720 to be displaced, deformed, or deflected in the direction of arrow D1, as shown in Figure 7E.

[0054] In the piezoelectric actuator example 700 shown in Figures 7A to 7E, the piezoelectric element 710 can experience some tensile stress in the expanded state shown in Figure 7D and some compressive stress in the contracted state shown in Figure 7E. However, since the piezoelectric element 710 is not directly coupled to the diaphragm 720, it does not experience bending stress even when a voltage is applied. This can be improved by avoiding the bending stress that would have been experienced during the bending / deformation / deflection of the diaphragm 720. Furthermore, in some examples, the first and second plates 740 and 750 can function as displacement amplifiers. Therefore, the configuration of the first and / or second plates 740 and 750 can reduce the amount of expansion or contraction of the piezoelectric element 710 required to achieve the desired deformation or deflection of the diaphragm 720, and thus reduce the amount of tensile and / or compressive force experienced by the piezoelectric element 710. Therefore, the performance and / or durability and / or reliability of the piezoelectric element 710, as well as the performance and / or durability and / or reliability of the pump or valve in which the piezoelectric actuator 700 is installed, can be further improved.

[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 a valve and / or pump of a fluid architecture of an embedded fluid-operated expandable device according to one embodiment.

[0056] As shown in Figure 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 sequentially from a first end to a second end. In the arrangement example shown in Figure 8A, the multilayered piezoelectric element 810 is attached to the diaphragm 820 by a first support bracket 840 at its first end and by a second support bracket 850 at its second end. In some examples, the first and second ends of the piezoelectric element 810 can be bonded to the first and second support brackets 840 and 850, respectively, by an epoxy layer 830. The example of the multilayered piezoelectric element 810 shown in Figure 8A includes, for illustrative purposes only, a plurality of substantially rectangular piezoelectric layers arranged in a stack extending diametrically across the diaphragm 820. The principles described herein can also be applied to multilayer piezoelectric elements containing more or fewer piezoelectric layers, and / or stacks of piezoelectric layers having different shapes, and / or stacks of piezoelectric layers having different arrangements than those shown in Figure 8A.

[0057] The first and second ends of the multilayer piezoelectric element 810 are coupled between the first and second support brackets 840 and 850, which are attached to the diaphragm 820. In the arrangement example shown in Figure 8A, the stack of piezoelectric layers forming the multilayer piezoelectric element 810 is coupled to the first and second support brackets 840 and 850, but does not directly contact the diaphragm 820. Rather, the portion of the multilayer piezoelectric element 810 between the first and second ends is spaced apart from the mounting surface of the diaphragm 820 so that a space 815 is formed between the bottom of the multilayer piezoelectric element 810 and the mounting surface of the diaphragm 820. Therefore, the intermediate portion of the multilayer 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 example shown in Figure 8A), for example in the direction indicated by the (single and double) arrow E shown in Figure 8A, causing corresponding movements of the first and second support brackets 840, 850 and corresponding vertical displacements of the piezoelectric element 810, the first and second support brackets 840, 850 and the diaphragm 820 (in the orientation example shown in Figure 8A), for example in the direction indicated by the (single and double) arrow F shown in Figure 8A.

[0058] For example, as shown in Figure 8B, when the piezoelectric element 810 expands in the directions of arrows E1 and E2 while the first and second support brackets 840 and 850 remain fixed between the piezoelectric element 810 and the diaphragm 820, a pivot occurs at the first end of the first support bracket 840 / piezoelectric element 810 in the direction of arrow G1, and a pivot occurs at the second end of the second support bracket 850 / piezoelectric element 810 in the direction of arrow G2. Therefore, in this arrangement, the first support bracket 840 functions as a pivot point 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 pivot point that allows the second end of the piezoelectric element 810 to pivot in the direction of arrow G2. Because the first and second support brackets 840 and 850 are coupled between the piezoelectric element 810 and the diaphragm 820, when the piezoelectric element 810 expands in this manner due to the application of voltage, the diaphragm 820 bends, deforms, or flexes in the direction of arrow F1, as shown in Figure 8B.

[0059] Similarly, as shown in Figure 8C, when the first end of the piezoelectric element 810 shrinks in the direction of arrow E2 and the second end shrinks in the direction of arrow E1 while the first and second support brackets 840 and 850 remain fixed between the piezoelectric element 810 and the diaphragm 820, a pivot occurs in the direction of arrow G2 at the first support bracket 840 / first end of the piezoelectric element 810, and a pivot occurs in the direction of arrow G1 at the second support bracket 850 / second end of the piezoelectric element 810. In this arrangement, the first support bracket 840 functions as a pivot point that allows the first end of the piezoelectric element 810 to pivot in the direction of arrow G2, and the second support bracket 850 functions as a pivot point that allows the second end of the piezoelectric element 810 to pivot in the direction of arrow G1. Because the first and second support brackets 840 and 850 are coupled between the piezoelectric element 810 and the diaphragm 820, when the piezoelectric element 810 contracts in this manner due to the application of voltage, the diaphragm 820 bends, deforms, or flexes in the direction of arrow F2, as shown in Figure 8C.

[0060] Figure 9A is a top perspective view of an example piezoelectric actuator 900 according to one embodiment, and Figure 9B is a cross-sectional view thereof. The example piezoelectric actuator 900 shown in Figures 9A and 9B can be used in a valve and / or pump of a fluid architecture of an embedded fluid-operated expandable device according to one embodiment.

[0061] As shown in Figures 9A and 9B, the piezoelectric actuator 900 includes a piezoelectric element 910 mounted on a diaphragm 920. In some examples, an adhesive layer 930 or epoxy layer 930 is placed between the piezoelectric element 910 and the diaphragm 920 to bond the piezoelectric element 910 to the diaphragm 920. In the arrangement examples shown in Figures 9A and 9B, the piezoelectric element 910 is substantially circular and in the form of a disc, for illustrative purposes only. Similarly, the diaphragm 920 shown in Figures 9A and 9B is also substantially circular, for illustrative purposes only. The principles described herein can also be applied to piezoelectric elements and / or diaphragms having other shapes and / or configurations.

[0062] In the arrangement examples shown in Figures 9A and 9B, the piezoelectric element 910 is coupled to a projection 924 or corrugation 924 surrounding the flat portion 922 of the diaphragm 920. Therefore, the piezoelectric element 910 is housed within the area of ​​the diaphragm 920 enclosed within the projection 924. The projection 924 surrounding the flat portion 922 of the diaphragm 920 can increase the displacement or deflection of the diaphragm 920 when a given level of voltage is applied to the piezoelectric element 910. As a result, the performance and / or reliability of the piezoelectric actuator 900 and / or the pump or valve in which the piezoelectric actuator 900 is installed can be improved. Furthermore, the protrusions 924 surrounding the flat portion 922 of the diaphragm 920 can improve the alignment of the piezoelectric element 910 on the diaphragm 920 during manufacturing, thereby suppressing variations among piezoelectric actuators 900 configured in this way and further improving the performance and / or reliability of the piezoelectric actuator 900 and / or the pump or valve on which the piezoelectric actuator 900 is installed.

[0063] While this specification has described some features of the embodiments described, many modifications, substitutions, changes, and equivalents will come to mind for those skilled in the art. Therefore, it should be understood that the appended claims are intended to cover all such modifications and changes that fall within the scope of these embodiments.

Claims

1. An embedded fluid-operated expandable device, Fluid reservoir and, Expandable member and A fluid control system configured to control the fluid flow between the fluid reservoir and the expandable member, The fluid control system is equipped with, Housing and A fluid architecture defining one or more fluid passages within the housing, At least one pump and at least one valve arranged within the one or more fluid passages, The at least one pump and the at least one valve include a piezoelectric actuator that is operable in response to a voltage supplied by the electronic control system of the fluid control system, and the piezoelectric actuator is Diaphragm and, A piezoelectric element coupled to the diaphragm and configured to deform in response to a voltage applied by the electronic control system, Includes, The diaphragm is configured to deform in response to the deformation of the piezoelectric element mounted on the diaphragm, The piezoelectric actuator acts the at least one pump and the at least one valve to control the flow of fluid in the one or more fluid passages based on either the amount of deformation of the diaphragm or the direction of deformation of the diaphragm. Embedded fluid-operated expandable device.

2. The piezoelectric element is The plate portion attached to the diaphragm, The open portion within the aforementioned plate portion, The plate portion includes the open portion, and the position of the open portion of the piezoelectric element corresponds to the high bending stress region of the piezoelectric actuator during deformation of the piezoelectric actuator. The embedded fluid-operated expandable device according to claim 1.

3. The open portion of the piezoelectric element is defined by a substantially circular opening in the central portion of the piezoelectric element, and the plate portion forms an annular ring surrounding the open portion. The embedded fluid-operated expandable device according to claim 1 or 2.

4. The plate portion includes a plurality of individual segments arranged around the opening, each of which is individually operable in response to a voltage applied by the electronic control system of the fluid control system. The embedded fluid-operated expandable device according to any one of claims 1 to 3.

5. Each of the plurality of individual segments is substantially the same in size and shape, and the plurality of individual segments are arranged substantially symmetrically around the central plane of the piezoelectric element. The embedded fluid-operated expandable device according to claim 4.

6. The diaphragm further comprises a projection that extends along its peripheral portion, the contour of which corresponds to the outer contour of the plate portion of the piezoelectric element, such that the piezoelectric element is housed within the area of ​​the diaphragm surrounded by the projection. The embedded fluid-operated expandable device according to any one of claims 1 to 5.

7. The piezoelectric actuator is 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 having a convex contour relative to the first side of the piezoelectric element, coupled to the first side of the piezoelectric element, A second plate having a convex contour relative to the second side of the piezoelectric element, which is coupled to the second side of the piezoelectric element opposite to the first side, A diaphragm coupled to the second plate and configured to deform in response to the deformation of the piezoelectric element, The embedded fluid-operated expandable device according to claim 1, including the above.

8. The distance between the central portion of the first plate and the diaphragm is greater than the distance between the peripheral portion of the first plate and the diaphragm. The distance between the central portion of the second plate and the diaphragm is greater than the distance between the peripheral portion of the second plate and the diaphragm. The embedded fluid-operated expandable device according to claim 7.

9. The peripheral edge of the first plate is coupled to the peripheral edge of the first side of the piezoelectric element. The peripheral edge of the second plate is coupled to the peripheral edge of the second side of the piezoelectric element. The diaphragm is coupled to the central portion of the central portion of the second plate, and the second plate is positioned between the diaphragm and the piezoelectric element. The embedded fluid-operated expandable device according to claim 7 or 8.

10. The piezoelectric element is configured to expand in the planar direction in response to a first applied voltage and to contract in the planar direction in response to a second applied voltage. The first plate and the second plate are configured to deform in response to the expansion or contraction of the piezoelectric element. The embedded fluid-operated expandable device according to any one of claims 7 to 9.

11. The first plate is configured to deform in a first direction, and the second plate is configured to deform in a second direction opposite to the first direction in response to the expansion of the piezoelectric element, thereby reducing the 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 the contraction of the piezoelectric element, thereby increasing the distance between the first plate and the second plate. The diaphragm is configured to deform in the first direction in response to the expansion of the piezoelectric element. The diaphragm is configured to deform in the second direction in response to the contraction of the piezoelectric element. The embedded fluid-operated expandable device according to claim 10.

12. The piezoelectric element is A stack of piezoelectric layers comprising a plurality of piezoelectric layers, wherein the plurality of piezoelectric layers are arranged sequentially from a first end to a second end of the stack of piezoelectric layers along the mounting surface of the diaphragm, A first support bracket connects the first piezoelectric layer at the first end of the stack of piezoelectric layers to the mounting surface of the diaphragm, A second support bracket connects the second piezoelectric layer at the second end of the stack of piezoelectric layers to the mounting surface of the diaphragm, The embedded fluid-operated expandable device according to claim 1, including the above.

13. The stack of piezoelectric layers is configured to expand in response to the applied first voltage. The first end of the stack of piezoelectric layers is configured to pivot in a first pivot direction in the first support bracket in response to the 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 in the second support bracket in response to the expansion of the stack of piezoelectric layers. The embedded fluid-operated expandable device according to claim 12.

14. The stack of piezoelectric layers is configured to shrink in response to the applied second voltage. The first end of the stack of piezoelectric layers is configured to pivot in a second pivot direction in the first support bracket in response to the reduction of the stack of piezoelectric layers. The second end of the stack of piezoelectric layers is configured to pivot in the second support bracket in the first pivot direction in response to the reduction of the stack of piezoelectric layers. The embedded fluid-operated expandable device according to claim 12 or 13.

15. The diaphragm is configured to deform in a first direction in response to the expansion of the stack of piezoelectric layers. The diaphragm is configured to deform in a second direction in response to the reduction of the stack of piezoelectric layers, a space is formed between the bottom of the piezoelectric element and the 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 the expansion of the stack of piezoelectric layers and decreases in response to the reduction of the stack of piezoelectric layers. The embedded fluid-operated expandable device according to any one of claims 12 to 14.

16. An embedded fluid-operated expandable device, Fluid reservoir and, Expandable member and A fluid control system configured to control the fluid flow between the fluid reservoir and the expandable member, The fluid control system is equipped with, Housing and A fluid architecture defining one or more fluid passages within the housing, At least one pump and at least one valve arranged within the one or more fluid passages, The at least one pump and the at least one valve include a piezoelectric actuator that is operable in response to a voltage supplied by the electronic control system of the fluid control system, and the piezoelectric actuator is A diaphragm is installed in one of the one or more fluid passages defined within the housing, and controls the flow of fluid 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, Includes, The diaphragm is configured to deform in response to the deformation of the piezoelectric element mounted on the diaphragm, The piezoelectric element is The plate portion attached to the diaphragm, The open portion within the aforementioned plate portion, The plate portion includes, and the plate portion surrounds the open portion. Embedded fluid-operated expandable device.

17. The open portion of the piezoelectric element is defined by a substantially circular opening in the central portion of the piezoelectric element, and the plate portion forms an annular ring surrounding the open portion. The embedded fluid-operated expandable device according to claim 16.

18. The plate portion includes a plurality of individual segments arranged around the opening, The embedded fluid-operated expandable device according to claim 16.

19. The position of the open portion of the piezoelectric element corresponds to the high bending stress region of the piezoelectric actuator during deformation of the piezoelectric actuator. The embedded fluid-operated expandable device according to claim 16.

20. 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. The embedded fluid-operated expandable device according to claim 18.

21. 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 detect the pressure of the fluid in the fluid passage. The embedded fluid-operated expandable device according to claim 18.

22. Each of the plurality of individual segments is substantially the same in size and shape, and the plurality of individual segments are arranged substantially symmetrically around the central plane of the piezoelectric element. The embedded fluid-operated expandable device according to claim 18.

23. The diaphragm further comprises a projection that extends along its peripheral portion, the contour of which corresponds to the outer contour of the plate portion of the piezoelectric element, such that the piezoelectric element is housed within the area of ​​the diaphragm surrounded by the projection. The embedded fluid-operated expandable device according to claim 16.

24. An embedded fluid-operated expandable device, Fluid reservoir and, Expandable member and A fluid control system is coupled between the fluid reservoir and the expandable member and configured to control the fluid flow between the fluid reservoir and the expandable member. The fluid control system is equipped with, Housing and A fluid control system including a fluid architecture that defines one or more fluid passages within the housing, At least one pump and at least one valve arranged within the one or more fluid passages, The at least one pump and the at least one valve include a piezoelectric actuator that is operable in response to a voltage supplied by the electronic control system of the fluid control system, and the piezoelectric actuator is 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 having a convex contour relative to the first side of the piezoelectric element, coupled to the first side of the piezoelectric element, A second plate having a convex contour relative to the second side of the piezoelectric element, which is coupled to the second side of the piezoelectric element opposite to the first side, A diaphragm coupled to the second plate and configured to deform in response to the deformation of the piezoelectric element, including, Embedded fluid-operated expandable device.

25. 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. 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. The embedded fluid-operated expandable device according to claim 24.

26. The peripheral edge of the first plate is coupled to the peripheral edge of the first side of the piezoelectric element. The peripheral edge of the second plate is coupled to the peripheral edge of the second side of the piezoelectric element. The diaphragm is coupled to the central portion of the central portion of the second plate, and the second plate is positioned between the diaphragm and the piezoelectric element. The embedded fluid-operated expandable device according to claim 24.

27. The piezoelectric element is configured to expand in the planar direction in response to a first applied voltage and to contract in the planar direction in response to a second applied voltage. The first plate and the second plate are configured to deform in response to the expansion or contraction of the piezoelectric element. The embedded fluid-operated expandable device according to claim 26.

28. The first plate is configured to deform in a first direction, and the second plate is configured to deform in a second direction opposite to the first direction in response to the expansion of the piezoelectric element, thereby reducing the 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 the contraction of the piezoelectric element to increase the distance between the first plate and the second plate. The embedded fluid-operated expandable device according to claim 27.

29. The diaphragm is configured to deform in the first direction in response to the expansion of the piezoelectric element. The diaphragm is configured to deform in the second direction in response to the contraction of the piezoelectric element. The embedded fluid-operated expandable device according to claim 28.

30. An embedded fluid-operated expandable device, Fluid reservoir and, Expandable member and A fluid control system configured to control the fluid flow between the fluid reservoir and the expandable member, The fluid control system is equipped with, Housing and A fluid architecture defining one or more fluid passages within the housing, At least one pump and at least one valve arranged within the one or more fluid passages, The at least one pump and the at least one valve include a piezoelectric actuator that is operable in response to a voltage supplied by the electronic control system of the fluid control system, and the piezoelectric actuator is A diaphragm is installed in one of the one or more fluid passages defined within the housing, and controls the flow of fluid 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 of the fluid control system, Includes, The diaphragm is configured to deform in response to the deformation of the piezoelectric element mounted on the diaphragm, The piezoelectric element is A stack of piezoelectric layers comprising a plurality of piezoelectric layers, wherein the plurality of piezoelectric layers are arranged sequentially from a first end to a second end of the stack of piezoelectric layers, A first support bracket connects the first piezoelectric layer at the first end of the stack of piezoelectric layers to the mounting surface of the diaphragm, A second support bracket connects the second piezoelectric layer at the second end of the stack of piezoelectric layers to the mounting surface of the diaphragm, including, Embedded fluid-operated expandable device.

31. The plurality of piezoelectric layers are arranged in order along the mounting surface of the diaphragm from the first end to the second end of the stack of piezoelectric layers. The embedded fluid-operated expandable device according to claim 30.

32. The stack of piezoelectric layers is configured to expand in response to the applied first voltage. The first end of the stack of piezoelectric layers is configured to pivot in a first pivot direction in the first support bracket in response to the 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 in the second support bracket in response to the expansion of the stack of piezoelectric layers. The embedded fluid-operated expandable device according to claim 31.

33. The stack of piezoelectric layers is configured to shrink in response to the applied second voltage. The first end of the stack of piezoelectric layers is configured to pivot in a second pivot direction in the first support bracket in response to the reduction of the stack of piezoelectric layers. The second end of the stack of piezoelectric layers is configured to pivot in the second support bracket in the first pivot direction in response to the reduction of the stack of piezoelectric layers. The embedded fluid-operated expandable device according to claim 32.

34. The diaphragm is configured to deform in a first direction in response to the expansion of the stack of piezoelectric layers. The diaphragm is configured to deform in a second direction in response to the reduction of the stack of piezoelectric layers. The embedded fluid-operated expandable device according to claim 33.

35. A space is formed between the bottom of the piezoelectric element and the 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 the expansion of the stack of piezoelectric layers and decreases in response to the contraction of the stack of piezoelectric layers. The embedded fluid-operated expandable device according to claim 33.

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