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

Abstract

An implantable fluid-actuated device can include a fluid reservoir configured to hold a fluid, an inflatable member, and a pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member. The pump assembly can include one or more fluid pumps and one or more valves. An electronic control system can control operation of the pump assembly based on fluid pressure and / or fluid flow measurements received from one or more sensing devices. The electronic control system can include internal components installed with the implantable device and external components that a user can operate to provide user inputs and receive outputs from the implantable device.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of and claims priority to U.S. Provisional Patent Application No. 17 / 655,958, entitled "FLUID CONTROL SYSTEM FOR AN IMPLANTABLE INFLATABLE DEVICE," filed on March 22, 2022, which claims priority to U.S. Provisional Patent Application No. 63 / 200,739, entitled "FLUID CONTROL SYSTEM FOR AN IMPLANTABLE INFLATABLE DEVICE," filed on March 25, 2021, the disclosures of which are incorporated herein by reference in their entireties.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 200,739, filed March 25, 2021, the disclosure of which is incorporated by reference in its entirety.

[0003] FIELD OF THE DISCLOSURE The present disclosure relates generally to bodily implants, and specifically to bodily implants including pumps. [Background technology]

[0004] Active implantable fluid-actuated devices often include one or more pumps that regulate the flow of fluid between different parts of the implantable device. One or more valves may be disposed within the fluid passages of the device to direct and control the flow of fluid to achieve inflation, deflation, pressurization, depressurization, activation, deactivation, etc., of different fluid-filled implant components of the device. In some implantable fluid-actuated devices, sensors may be used to monitor the fluid pressure and / or volume within the fluid passages of the device. Accurate monitoring of conditions within the device, including pressure monitoring and flow monitoring, may allow for improved control of device operation, improved diagnostics, and improved device effectiveness. Sensors may also be used to monitor external conditions of the device, including acceleration, angle, air pressure, and temperature, to facilitate determining the operating mode of the device. 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 an electronic fluid control system coupled between the fluid reservoir and the inflatable member and configured to control fluid between the fluid reservoir and the inflatable member. The electronic fluid control system includes a housing, a fluid control system contained within the housing including a fluid architecture including at least one valve and at least one pump disposed within a fluid passage within the housing, and an electronic control system contained within the housing, the electronic control system including at least one processor configured to control operation of the at least one pump and the at least one valve, and a communication module configured to communicate with at least one external device. The implantable fluid-actuated inflatable device may also include at least one pressure sensing device configured to sense fluid pressure within the implantable fluid-actuated inflatable device and transmit the sensed pressure to the electronic control system.

[0006] In some implementations, the reservoir is coupled to an exterior surface of the housing. In some implementations, the reservoir includes a bellows structure configured to contract as fluid is expelled from the reservoir and to expand as fluid is introduced into the reservoir. In some implementations, the reservoir is contained within the housing. In some implementations, a closed bellows filled with a compressible fluid is provided within the housing so as to contract in response to reservoir expansion and expand in response to reservoir contraction.

[0007] In some implementations, the electronic control system is configured to receive user input from an external device and control operation of the at least one pump and at least one valve in response to the received user input. In some implementations, the electronic control system is configured to coordinate operation of the at least one pump and at least one valve to reduce pressure in the inflatable member and initiate deflation of the inflatable member in response to detection of a signal generated by interaction of the electronic control system with a magnet disposed corresponding to the fluid-controlled inflatable device for a preset period of time. In some implementations, the electronic control system is configured to control operation of the at least one pump and at least one valve in response to user input including at least one of a pressure change detected by the at least one sensing device in response to a tapping input or tagging input, or a motion event detected by a motion detection device of the fluid-operated inflatable device or the external device. The tapping input can include a series of taps in a preset sequence detected by a piezoelectric element of the at least one pump or at least one valve. The preset sequence may include a wake-up sequence for waking up the fluid-actuated inflatable device, the wake-up sequence including a first tapping sequence defined by a first number of taps in a first pattern, and an activation sequence responsive to a user input, the activation sequence including a second tapping sequence defined by a second number of taps in a second pattern.

[0008] In some implementations, the electronic control system is configured to monitor the pressure level within the fluid-controlled inflatable device and control the operation of the at least one pump and at least one valve in response to detected pressure fluctuations, including controlling the at least one pump and at least one valve to reduce the pressure in the inflatable member to deflate the inflatable member in response to detecting that the inflatable member is in an inflated state for longer than a preset period of time, controlling the at least one pump and at least one valve to maintain a current state of the fluid-controlled inflatable device in response to detecting a pressure spike having a duration shorter than the preset period of time, and controlling the at least one pump and at least one valve to maintain a current state of the fluid-controlled inflatable device in response to detecting a change in atmospheric conditions.

[0009] In some implementations, the electronic control system is configured to detect a failure of the fluid-controlled inflatable device in response to detecting that the time to reach the set pressure exceeds a set period of time or that the set pressure cannot be reached, output an alert about the detected failure to an external device, and isolate fluid from the area of ​​the detected failure.

[0010] In some implementations, the at least one pump includes a first piezoelectric pump in a first fluid channel of the fluidic architecture and a second piezoelectric pump in a second fluid channel of the fluidic architecture, where in a deflation mode, the first piezoelectric pump is configured to operate to pump fluid from the inflatable member to the reservoir while the second piezoelectric pump is in a standby mode, where the second piezoelectric pump in the standby mode can capture vibrations caused by operation of the first piezoelectric pump for conversion to energy. In an inflation mode, the second piezoelectric pump is configured to operate to pump fluid from the reservoir to the inflatable member while the first piezoelectric pump is in a standby mode, where the first piezoelectric pump in the standby mode can capture vibrations caused by operation of the second piezoelectric pump for conversion to energy. In a standby mode of the fluid-actuated inflatable device, where both the first and second piezoelectric pumps are in a standby mode, the first and second piezoelectric pumps can capture vibrations caused by movement of a patient in which the fluid-actuated inflatable device is implanted for conversion to energy.

[0011] In some implementations, the fluid architecture includes a first one-way pump and a first passive valve disposed in a first fluid passageway to selectively generate and control fluid flow in a first direction from the inflatable member to the reservoir, a second one-way pump and a second passive valve disposed in a second fluid passageway to selectively generate and control fluid flow in a second direction from the reservoir to the inflatable member, a first sensing device disposed to sense fluid pressure in the reservoir, a second sensing device disposed to sense fluid pressure in the inflatable member, and an active valve disposed along the inflatable member. In a first mode, the active valve can be configured to be closed by an electronic control system in response to detection of a pressure spike in the inflatable member to prevent deflation of the inflatable member. In a second mode, the active valve can be configured to be opened by an electronic control in response to detection of a loss of power to the electronic fluid control system to allow deflation of the inflatable member.

[0012] In some implementations, the fluid architecture includes a first one-way pump disposed in the first fluid passage and configured to generate a fluid flow in a first direction from the inflatable member toward the reservoir, a second one-way pump disposed in the second fluid passage and configured to generate a fluid flow in a second direction from the reservoir toward the inflatable member, and a second one-way pump configured to restrict fluid flow in the first direction in the first fluid passage and prevent backflow of fluid in the first fluid passage while the second one-way pump is in the operating mode and the first one-way pump is in the standby mode. a first passive valve disposed in one fluid passage between the first one-way pump and the reservoir; a second passive valve disposed in the second fluid passage between the second one-way pump and the reservoir to restrict fluid flow in the second fluid passage in a second direction and prevent backflow of fluid in the second fluid passage while the first one-way pump is in the operating mode and the second one-way pump is in the standby mode; a first sensing device disposed to sense fluid pressure in the reservoir; and a second sensing device disposed to sense fluid pressure in the inflatable member.

[0013] In some implementations, the fluidic architecture includes a one-way pump disposed in the fluid passage, a first active valve disposed in the fluid passage between the pump and a reservoir and configured to be selectively actuated by the electronic control system, a second active valve disposed in the fluid passage between the pump and the inflatable member and configured to be selectively actuated by the electronic control system, a third active valve disposed in the fluid passage between the pump and the reservoir and configured to be selectively actuated by the electronic control system, and a fourth active valve disposed in the fluid passage between the pump and the inflatable member and configured to be selectively actuated by the electronic control system. In an inflation mode, the first and second active valves are opened by the electronic control system and the third and fourth active valves are closed by the electronic control system to pump fluid from the reservoir to the inflatable member. In a deflation mode, the electronic control system opens the third active valve and the fourth active valve, and the electronic control system closes the first active valve and the second active valve, thereby pumping fluid from the inflatable member to the reservoir.

[0014] In some implementations, the fluid architecture includes a first compound pump and valve device disposed in the first fluid passage to selectively generate and control fluid flow in a first direction from the inflatable member to the reservoir, a first sensing device disposed to sense fluid pressure in the reservoir, a second compound pump and valve device disposed in the second fluid passage to selectively generate and control fluid flow in a second direction from the reservoir to the inflatable member, and a second sensing device disposed to sense fluid pressure in the inflatable member.

[0015] In some implementations, the fluidic architecture includes a first piezoelectric pump and valve device disposed in the first fluid passage and configured to selectively generate and control fluid flow in a first direction from the inflatable member to the reservoir and sense fluid pressure in the reservoir, and a second piezoelectric pump and valve device disposed in the second fluid passage and configured to selectively generate and control fluid flow in a second direction from the reservoir to the inflatable member and sense fluid pressure in the inflatable member. In some implementations, the fluidic architecture includes a pump, a first three-way valve disposed between the pump and the reservoir having a first port that opens to maintain fluid communication with the pump, and a second three-way valve disposed between the pump and the inflatable member having a first port that opens to maintain fluid communication with the pump. In a deflation mode, the second port of the first three-way valve is open and the third port of the first three-way valve is closed to direct fluid flow from the first port to the second port of the first three-way valve, the second port of the second three-way valve is open and the third port of the second three-way valve is closed to direct fluid flow from the first port to the second port of the second three-way valve, and in an inflation mode, the second port of the first three-way valve is closed and the third port of the first three-way valve is open to direct fluid flow from the first port to the third port of the first three-way valve, and the second port of the second three-way valve is closed and the third port of the second three-way valve is open to direct fluid flow from the first port to the third port of the second three-way valve. [Brief description of the drawings]

[0016] [Figure 1] FIG. 1 is a block diagram of an implantable fluid-actuated inflatable device according to an embodiment. [Figure 2A] 1A-1C illustrate example implantable fluid-actuated inflatable devices according to certain aspects. [Figure 2B] 1A-1C illustrate example implantable fluid-actuated inflatable devices according to certain aspects. [Diagram 3] 1 is a schematic diagram of a fluid architecture of an implantable fluid-actuated inflatable device, according to an embodiment. [Figure 4]FIG. 1 is a schematic diagram of an example electronic fluid control system for an implantable fluid-actuated inflatable device. [Diagram 5] FIG. 5 is a schematic diagram of a first example fluid architecture of the example fluid control system shown in FIG. [Figure 6] FIG. 5 is a schematic diagram of a second example fluid architecture of the example fluid control system shown in FIG. [Figure 7] FIG. 5 is a schematic diagram of a third example fluid architecture of the example fluid control system shown in FIG. [Figure 8] FIG. 5 is a schematic diagram of a fourth example fluid architecture of the example fluid control system shown in FIG. [Figure 9] FIG. 5 is a schematic diagram of a fifth example fluid architecture of the example fluid control system shown in FIG. [Figure 10] FIG. 5 is a schematic diagram of a sixth example fluid architecture of the example fluid control system shown in FIG. [Figure 11] FIG. 13 is a schematic diagram of a seventh example fluid architecture of the example fluid control system shown in FIG. [Figure 12A] 1 is a schematic diagram of an example implantable fluid-actuated inflatable device, according to certain aspects. [Figure 12B] 1 is a schematic diagram of an example implantable fluid-actuated inflatable device, according to certain aspects. [Figure 12C] 1 is a schematic diagram of an example implantable fluid-actuated inflatable device, according to certain aspects. [Figure 13A] 1 is a schematic diagram of an example implantable fluid-actuated inflatable device, according to certain aspects. [Figure 13B] 1 is a schematic diagram of an example implantable fluid-actuated inflatable device, according to certain aspects. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Detailed implementations are disclosed herein. However, it should be understood that the disclosed implementations are merely examples and can be embodied in various forms. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limitations, but merely as a basis for the claims and as representative basis for teaching those skilled in the art that these implementations can be variously employed in substantially any suitable detailed structure. Moreover, the terms and expressions used herein are not intended to be limiting, but are intended to provide an understandable description of the present disclosure.

[0018] The term "a" as used herein is defined as one or more than one. The term "another" as used herein is defined as at least a second or more. The terms "including" and / or "having" as used herein are defined as comprising (i.e., an open transition). The terms "coupled" or "moveably coupled" as used herein are defined as connected, although not necessarily directly and mechanically.

[0019] In general, the implementation relates to a body implant. Hereinafter, the term patient or user can be used for a person who will benefit from the medical device or method disclosed in this disclosure. For example, a patient can be a person in whose body a medical device or the disclosed method for operating a medical device according to the present disclosure is implanted.

[0020] FIG. 1 is a block diagram of an example implantable fluid-actuated inflatable device 100. The example device 100 shown in FIG. 1 includes a fluid reservoir 102, an inflatable member 104, and a fluid control system 106 including 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 can include one or more sensing devices that sense conditions, such as fluid pressure and fluid flow rate, within the fluid system of the device 100. In some implementations, the example 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 implantable fluid-actuated inflatable device 100 and / or communication with one or more external devices. In some examples, the electronic control system 108 includes, for example, a processor, memory, a communication module, a power storage device or battery, a sensing device, for example, an accelerometer, and other such components configured to enable operation and control of the implantable fluid-actuated inflatable device 100. For example, the communication module can enable communication with one or more external devices, for example, an external controller 120. The external controller 120 can be configured to receive user input, for example, through a user interface, and transmit the user input, for example, through the communication module, to the electronic control system 108 for processing, operation, and control of the device 100. The electronic control system 108 can transmit operational information to the external controller 120 through the communication module. This can enable, for example, providing an operational status of the inflatable device 100 to a user through a user interface, providing diagnostic information to a physician, and the like. In some examples, the external controller 120 includes a power transfer module that enables charging of components of the internal electronic control system 108. In some examples, power transfer for recharging the internal electronic control system 108 occurs in an external device separate from the external controller 120.In some implementations, the external controller 120 can include sensing devices such as pressure sensors, acceleration sensors, and other such sensing devices. An external pressure sensor in the external controller 120 can provide the internal electronic control system 108 with a local atmospheric pressure or an operating pressure, etc., so that the inflatable device 100 can compensate for pressure fluctuations. An accelerometer in the external controller 120 can provide detected patient movement to the internal electronic control system 108 for control of the inflatable device 100. The fluid reservoir 102, the inflatable member 104, and the fluid control system 106 can be implanted within the 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 separated 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 separated 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 communicates with other modules of the electronic control system 108 included in the implantable device 100. In some implementations, the operation of the implantable fluid-actuated inflatable device 100 can be manually controlled.

[0021] In some examples, electronic monitoring and control of the fluid-actuated inflatable device 100 may 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 may provide an opportunity for a physician to adjust the operation of the device 100 without further surgical intervention. The fluid architecture that defines the flow and control of fluid through the fluid-actuated inflatable device 100, including the placement of fluid components such as pumps, valves, and sensing devices, may enable the device 100 to respond effectively to user inputs and quickly and effectively adapt to both changes in internal conditions of the inflatable device 100 (such as changes in pressure and flow rate) and changes in conditions external to the inflatable device 100 (such as pressure spikes due to physical activity and impacts, sustained pressure changes due to changing atmospheric conditions, and other such changes in external conditions).

[0022] The example 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, as shown in Figure 2A, an inflatable penile prosthesis 100B, as shown in Figure 2B, and other such implantable inflatable devices that rely on controlling fluid flow to components of the device to achieve inflation, pressurization, deflation, depressurization, deactivation, and the like.

[0023] The example artificial urinary sphincter 100A shown in FIG. 2A includes a fluid control system 106A including fluid components such as pumps, valves, and sensing devices disposed in a fluid passageway, and an electronic control system 108A configured to enable transfer of fluid between the reservoir 102A and the 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 may be housed within a housing 110A. A first fluid port 107A of the fluid control system 106A / electronic control system 108A housed within the housing 110A is connected to the reservoir 102A by a first conduit 103A. A second fluid port 109A of the fluid control system 106A / electronic control system 108A housed within the housing 110A is connected to the inflatable cuff 104A by a second conduit 105A.

[0024] The example penile prosthesis 100B shown in FIG. 2B includes a fluid control system 106B including fluid components such as pumps, valves, and sensing devices disposed in a fluid passageway, and an electronic control system 108B configured to enable transfer of fluid between the fluid reservoir 102B and the inflatable cylinder 104B through 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 fluid port 107B of the fluid control system 106B / electronic control system 108B housed in the housing 110B is connected to the reservoir 102B by a first conduit 103B. One or more second fluid ports 109B of the fluid control system 106A / electronic control system 108A housed in the housing are connected to the inflatable cylinder 104B by one or more second conduits 105B.

[0025] The principles described herein may be applied to these and other types of implantable, fluid-actuated, inflatable devices that rely on a pump assembly containing various fluid components for effective operation to allow for the transfer of fluid between different fluid-filled implantable components to achieve inflation, deflation, pressurization, depressurization, deactivation, occlusion, etc. The example devices 100A, 100B shown in Figures 2A and 2B may include electronic control systems 108A, 108B that allow for monitoring and control of pressure and / or fluid flow through the respective devices 100A, 100B. Some of the principles described herein may also be applied to manually controlled implantable, fluid-actuated devices.

[0026] As discussed above with respect to FIG. 1, the fluid control system 106 can include a pump assembly including 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, for example, the fluid reservoir 102 and the inflatable member 104. In some examples, the pump(s) and / or the valve(s) are electronically controlled. In some examples, the pump(s) and / or the valve(s) are manually controlled. In some examples, the pump assembly includes a fluid manifold having fluid channels formed therein that define the fluid circuit. In examples where the pump assembly is electronically driven and / or controlled, the manifold can be a sealed manifold that can contain and compartmentalize the fluid flow from the electronic components of the pump assembly to prevent leakage and / or gas exchange. In some examples, the pump assembly includes one or more pressure sensing devices in the fluid circuit that enable relatively accurate monitoring and control of the 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 deactivation of components of an implantable fluid-actuated device, resulting in patient safety and device efficacy.

[0027] Figure 3 is a schematic diagram of an example fluid architecture of an implantable fluid-actuated inflatable device, according to one embodiment. The fluid architecture of an implantable fluid-actuated inflatable device may include fluid channels, valve(s), pressure sensor(s), and other components other than those shown in Figure 3. A fluid architecture that can accommodate back pressure, pressure surges, and the like, enhances the performance, effectiveness, and efficiency of the fluid-actuated device 100.

[0028] The example fluidic architecture shown in FIG. 3 includes channels directing fluid flow between the reservoir 102 and the inflatable member 104. In the example shown in FIG. 3, a first valve V1 in the first fluidic channel controls the fluid flow from the inflatable member 104 to the reservoir 102, which is generated by a first pump P1. A second valve V2 in the second fluidic channel controls the fluid flow from the reservoir 102 to the inflatable member 104, which is generated by a second pump P2. A first sensing device S1 senses the fluid pressure in the reservoir 102, and a second sensing device S2 senses the fluid pressure in the inflatable member 104. The first and second sensing devices S1, S2 may enable monitoring of the fluid flow and / or fluid pressure in the fluidic channels. In the arrangement shown in FIG. 3, either the first pump P1 or the second pump P2 is activated while the other of the first pump P1 or the second pump P2 is in a standby mode, and the first and second pumps are not normally operated simultaneously. The control system 108 as described above can control the operation of the first and second pumps P1, P2 and the first and second valves V1, V2 (between open and closed states) based on conditions (e.g., fluid pressure and / or fluid flow rate) within the first and second fluid channels in areas adjacent to the reservoir 102 and the inflatable member 104 detected by the first and second sensing devices S1, S2.

[0029] For example, the first pump P1 may operate with the first valve V1 open (and the second pump P2 in standby mode with the second valve V2 closed) to deflate the inflatable member 104. The first pump P1 continues to operate (e.g., based on fluid pressure sensed by the second sensing device S2) until pressure sensed by the second sensing device S2 (along the inflatable member 104) indicates that a desired deflated state of the inflatable member 104 has been achieved. To maintain the deflated state, both the first and second pumps P1, P2 may be placed in standby mode and both the first and second valves V1, V2 may be closed. The second pump P2 may operate with the second valve V2 open (and the first pump P1 in standby mode with the first valve V1 closed) to inflate the inflatable member 104. The second pump P2 continues to operate (e.g., based on fluid pressure sensed by the first sensing device S2) until the pressure sensed by the first sensing device S1 indicates that the desired inflation state of the inflatable member 104 has been achieved. To maintain the inflation state, both the first and second pumps P1, P2 can be placed in a standby mode and both the first and second valves V1, V2 can be closed. The valves V1, V2 can enable selective sealing of the respective fluid channels to maintain a setting state of the fluid-actuated device. Interaction with the valves V1, V2 (and corresponding changes in fluid flow through the fluid architecture of the device) can change the setting state of the fluid-actuated device. Valves V1, V2 that maintain the setting state of the device until the patient desires and initiates the required change in the setting state of the device provide enhanced patient safety and improved efficacy of the device.

[0030] In some examples, one or more valves included in the fluidic architecture are normally open valves. Normally open valves are open by default and close (and remain closed) in response to application of power. The use of normally open valves in the example arrangement shown in FIG. 3 can provide a fail-safe in the event of a power outage or other system failure that results in loss of control of pumps P1, P2 and / or valves V1, V2. For example, if the inflatable member 104 is inflated, valves V1, V2 are closed, and pumps P1, P2 are in a standby state, such loss of control due to a loss of power (or other system failure) could cause patient discomfort and / or compromise patient safety. The use of normally open valves in the fluidic architecture allows valves V1, V2 to open upon loss of power, relieving pressure from the inflatable member 104 and allowing fluid in the system to equilibrate.

[0031] In some examples, one or more of the valves included in the fluidic architecture may be normally closed valves that are closed by default and open (and remain open) in response to application of power. Normally closed valves may not provide the fail-safe measures described above depending on the location of the normally closed valves in the fluidic architecture. However, the use of one or more normally closed valves in the fluidic architecture may reduce power consumption of the fluid-actuated inflatable device 100. Many of the valves included in the fluidic architecture remain closed for a significantly longer period of time than they would remain open (e.g., to maintain the current state of the fluid-actuated inflatable device 100). Because the normally closed valves are closed by default and do not rely on application of power to maintain the closed state, the use of one or more normally closed valves in the fluidic architecture may reduce power consumption (compared to the use of normally open valves). This may result in an increased life span of the fluid-actuated inflatable device 100, reduced medical intervention required for continued operation (e.g., power battery replacement), and / or reduced recharging requirements and / or extended recharging intervals.

[0032] Power consumption can be reduced by passively moving fluid through the fluid channels of the fluid-operated inflatable device 100 to reduce the amount of pumping required to achieve a desired level of deflation of the inflatable member 104. For example, in an inflated state, the pressure in the inflatable member 104 is higher than the pressure in the reservoir 102. In the exemplary arrangement shown in FIG. 3, the first valve V1 can be opened to allow fluid to flow naturally out of the inflatable member 104 (with the first pump P1 not operating, the second valve V2 closed, and the second pump P2 in standby mode) to achieve a desired level of deflation of the inflatable member 104. To remove any residual pressure not removed by such passive fluid flow from the inflatable member 104, the first pump P1 can be operated based on the fluid pressure sensed by the first and / or second sensing devices S1, S2.

[0033] In some examples, pressure sensing devices (such as sensing devices S1, S2 shown in the example fluid architecture depicted in FIG. 3) can support a variety of different pressure regulation, measurement, and control methods in the fluid architecture of the fluid-actuated inflatable device 100, and these pressure sensing devices can be positioned to enable monitoring of fluid pressure in the reservoir 102 and inflatable member 104. For example, sensing devices S1, S2 (and / or other pressure sensing devices) can be positioned to detect sudden increases or spikes in fluid pressure at various locations within the fluid-actuated inflatable device 100 and accordingly control pumps P1, P2 and valves V1, V2 to maintain the current state of the fluid-actuated inflatable device 100 and / or enable patient comfort and safety.

[0034] For example, the fluid reservoir 102A of the example artificial urinary sphincter 100A described above with respect to FIG. 2A is placed in the abdominal cavity of the patient. Thus, a pressure sensing device (such as the first sensing device S1) located in the fluid reservoir 102A can provide an indication of abdominal pressure. If a spike or sudden increase in pressure (e.g., due to physical activity, impact, fall, etc.) is detected by the first sensing device S1, the system can respond, for example, by increasing the pressure in the inflatable cuff 104A, so that the patient can remain continent throughout the pressure spike. In an example including a first sensing device S1 in the reservoir 102A and a second sensing device S2 in the inflatable cuff 104A, the pressure measurements obtained by each of the sensors S1, S2 can be used to determine, for example, how much pressure is needed in the inflatable cuff 104A to counteract the pressure spike in the reservoir 102A.

[0035] As mentioned above, in an inflated state, the pressure in the inflatable member 104 is higher than the pressure in the reservoir 102. The pressure difference between the inflatable member 104 and the reservoir 102 can be used to passively deflate the inflatable member 104. Once the fluid in the inflatable device 100 is in equilibrium, measurements from the sensing devices S1, S2 located in the reservoir 102 and the inflatable member 104 as shown in the example fluidic architecture of FIG. 3 can be used to determine when to engage the first pump P1 to maximize energy conservation while governing when to transition the inflatable member 104 from an inflated state to a desired deflated level. In some examples, the positioning of the first and second sensing devices S1, S2 as shown can detect blockages, slow leaks, etc. in the fluidic architecture and enable the system to operate the pumps P1, P2 and valves V1, V2 to compensate for the detected faults.

[0036] 3, the first valve V1 can be opened to allow natural fluid flow out of the inflatable member 104 (with the first pump P1 not operating, the second valve V2 closed, and the second pump P2 in standby mode) to achieve a desired level of deflation of the inflatable member 104. The first pump P1 can be operated based on fluid pressure sensed by the first and / or second sensing devices S1, S2 to remove any residual pressure not removed by such passive fluid flow from the inflatable member 104.

[0037] FIG. 4 is a schematic diagram of an example electronic fluid control system 400 of an implantable fluid-actuated inflatable device, according to an embodiment. In some examples, the electronic fluid control system 400 enables the transfer of fluid between the reservoir 102 and the inflatable member 104, and the monitoring and control of the components of the fluid architecture in the fluid control system 106. In some examples, the electronic control system 108 controls the operation of the components of the fluid architecture of the fluid control system 106. In some examples, the electronic control system 108 includes a printed circuit board (PBC) 140. In some examples, the PCB 140 includes a processor, memory, a communication module, a sensing device, and other such components. In some examples, the electronic control system 108 communicates with an external controller 120, such as to receive user input and output information to a user. In some examples, the control system 108 includes a power storage device 130 or a battery 130 that provides power for the operation of the components of the electronic control system 108 and the components of the fluid control system 106. In some examples, the power storage device 130 may be recharged, for example, by an external recharging device 150. In some examples, the fluid control system 106 and its components and the electronic control system 108 and its components are contained within a housing 110.

[0038] 5 illustrates an example electronic fluid control system 400 including a fluid control system 106 having an example first fluid architecture 410. The example first fluid architecture 410 includes a first pump P1 and a first valve V1 that control fluid flow in a first direction from the inflatable member 104 to the reservoir 102, and a second pump P2 and a second valve V2 that control fluid flow in a second direction from the reservoir 102 to the inflatable member 104. In the example first fluid architecture 410 illustrated in FIG. 5, the first pump P1 is a one-way pump and the first valve V1 is a passive check valve that restricts flow in a first fluid channel to only allow flow in the first direction. The second pump P2 is a one-way pump and the second valve V2 is a passive check valve that restricts flow in a second fluid channel to only allow flow in the second direction. A first sensing device S1 is positioned to sense fluid pressure in the reservoir 102, and a second sensing device S2 is positioned to sense fluid pressure in the inflatable member 104. First and second passive check valves V1, V2 positioned as shown relative to the first and second pumps P1, P2 prevent backflow of fluid through the pumps P1, P2. The first example fluid architecture 410 includes an active valve AV positioned along the inflatable member 104. The active valve AV positioned as shown can respond to a sudden pressure spike in the inflatable member 104, such as due to an impact, physical movement, a fall, etc., to prevent fluid from leaking out of the inflatable member 104 and backflowing through the first pump P1, unintentionally deflating the inflatable member 104.

[0039] 6 illustrates an example electronic fluid control system 400 including a fluid control system 106 having an example second fluid architecture 420. The example second fluid architecture 420 includes a first pump P1 and a first valve V1 that control fluid flow in a first direction from the inflatable member 104 to the reservoir 102, and a second pump P2 and a second valve V2 that control fluid flow in a second direction from the reservoir 102 to the inflatable member 104. In the example second fluid architecture 420 illustrated in FIG. 6, the first pump P1 is a one-way pump and the first valve V1 is a passive check valve that restricts flow in a first fluid channel to only allow flow in a first direction. The second pump P2 is a one-way pump and the second valve V2 is a passive check valve that restricts flow in a second fluid channel to only allow flow in a second direction. A first sensing device S1 is positioned to sense fluid pressure in the reservoir 102 and a second sensing device S2 is positioned to sense fluid pressure at the inflatable member 104. A first passive check valve V1, positioned as shown relative to the first pump P1, prevents backflow of fluid through the first pump P1 and accidental fluid flow from the inflatable member 104 to the reservoir 102. A second passive check valve V2, positioned as shown, prevents backflow of fluid through the second pump P2.

[0040] 7 illustrates an example electronic fluid control system 400 including a fluid control system 106 having an example third fluid architecture 430. The example third fluid architecture 430 includes a first pump P1 and a first valve V1 that control fluid flow in a first direction from the inflatable member 104 to the reservoir 102, and a second pump P2 and a second valve V2 that control fluid flow in a second direction from the reservoir 102 to the inflatable member 104. In the example third fluid architecture 430, the first pump P1 is a one-way pump and the first valve V1 is a passive check valve that restricts flow in a first fluid channel to only allow flow in the first direction. The second pump P2 is a one-way pump and the second valve V2 is a passive check valve that restricts flow in a second fluid channel to only allow flow in the second direction. The first sensing device S1 is positioned to sense the fluid pressure in the reservoir 102, and the second sensing device S2 is positioned to sense the fluid pressure in the inflatable member 104. First and second passive check valves V1, V2 positioned as shown relative to the first and second pumps P1, P2 prevent backflow of fluid through the pumps P1, P2. The third example fluidic architecture 430 includes an active valve AV positioned to function as a fail-safe in the event of a loss of power. In the arrangement of components shown in the third example fluidic architecture, the active valve AV can be a normally open valve. In the event of a loss of power to the electronic fluid control system 400, the active valve AV opens to allow depressurization of the inflatable member 104, thus allowing patient comfort and safety.

[0041] 8 illustrates an example electronic fluid control system 400 including a fluid control system 106 having a fourth example fluid architecture 440. The fourth example fluid architecture 440 employs one pump P2 and four active valves AV1, AV2, AV3, and AV4 to transfer fluid between the reservoir 102 and the inflatable member 104. In an example where the active valves are piezoelectric valves, the first, second, third, and fourth active valves AV1, AV2, AV3, AV4 may be actively and selectively opened and closed in response to selective application of voltages. By actively opening the first active valve AV1 and the second active valve AV2 and actively closing the third active valve AV3 and the fourth active valve AV4, fluid may be pumped from the reservoir 102 to the inflatable member 104 to inflate the inflatable member 104. By actively closing the first active valve AV1 and the second active valve AV2 and actively opening the third active valve AV3 and the fourth active valve AV4, fluid can be pumped from the inflatable member 104 to the reservoir 102 to cause the inflatable member 104 to deflate.

[0042] FIG. 9 illustrates an example electronic fluid control system 400 including a fluid control system 106 having a fifth example fluid architecture 450. The fifth example fluid architecture 440 employs one pump P1, similar to the fourth example fluid architecture 440. The fifth example fluid architecture 450 illustrated in FIG. 9 replaces the four active valves AV1, AV2, AV3, and AV4 illustrated in FIG. 8 with two three-way latch valves LV1 and LV2. In the fifth example fluid architecture, port 1 of the first latch valve LV1 and port 1 of the second latch valve LV2 are always open. When the first latch valve LV1 is energized, one of the other ports 2 or 3 of the first latch valve LV1 can communicate with the open port 1. Similarly, when the second latch valve LV2 is energized, one of the other ports 2 or 3 of the second latch valve LV2 can communicate with the open port 1. Selecting port 2 of both the first and second latch valves LV1 and LV2 closes port 3 of each of the first and second latch valves LV1 and LV2, allowing fluid to flow between ports 1 and 2 to allow the pump P1 to transfer fluid from the inflatable member 104 to the reservoir 102. Similarly, selecting port 3 of each of the latch valves LV1, LV2 (thereby closing port 2) allows fluid to flow between ports 1 and 3 to allow the pump to transfer fluid from the reservoir 102 to the inflatable member 104.

[0043] 10 illustrates an example electronic fluid control system 400 including a fluid control system 106 having an example sixth fluid architecture 460. The example sixth fluid architecture includes a first pump P1 that generates a fluid flow in a first direction from the inflatable member 104 to the reservoir 102, and a second pump P2 that generates a fluid flow in a second direction from the reservoir 102 to the inflatable member 104. In the example sixth fluid architecture 460 illustrated in FIG. 10, the first pump P1 and the second pump P2 are combined pump and valve devices. For example, the first pump P1 prevents fluid flow through a first fluid channel when in a standby mode and thus is not operating / pumping. Similarly, the second pump P2 prevents fluid flow through a second fluid channel when in a standby mode.

[0044] FIG. 11 illustrates an example electronic fluid control system 400 including a fluid control system 106 having an example seventh fluid architecture 470. The example seventh fluid architecture includes a first pump P1 for generating fluid flow in a first direction from the inflatable member 104 to the reservoir 102, and a second pump P2 for generating fluid flow in a second direction from the reservoir 102 to the inflatable member 104. In the example seventh fluid architecture 470 illustrated in FIG. 11, the first pump P1 and the second pump P2 are combined pump and valve devices similar to the example sixth fluid architecture 460 illustrated in FIG. 10, and thus, in addition to generating fluid flow through the fluid channels, can selectively restrict flow through the fluid channels between the reservoir 102 and the inflatable member 104. However, in the example seventh fluid architecture 470 illustrated in FIG. 11, the first and second pumps P1, P2 can be piezoelectric pumps. The piezoelectric elements of the piezoelectric pumps can sense changes in pressure. Thus, in the seventh example fluidic architecture 470, the first and second pumps P1, P2 (in the form of piezoelectric pumps) can also function as pressure sensing devices, thus eliminating the sensing devices S1, S2 shown in previous fluidic architectures. This can result in a simplified fluidic architecture for the fluid control system 106 and a reduced overall size of the electronic fluidic control system 400.

[0045] Thus, in some examples, one or more of the valves included in the fluidic architecture of the fluid control system 106 can be piezoelectric valves. Piezoelectric materials generate electrical energy when subjected to mechanical tensile deformation. Conversely, piezoelectric materials deform in response to the application of an electric field. That is, piezoelectric materials can convert charge into motion and motion into charge. These properties allow for electronic control of mechanical valves through the application of voltages to the valves. During operation, the fluid-actuated inflatable device 100 can receive or experience external stimuli, such as vibrations. The source of the vibrations can be, for example, vibrations generated by the operation of one of these pumps, vibrations generated by the movement of fluid through the fluid-actuated inflatable device 100, user movement and / or other physical activity, and other such sources internal and external to the device 100. Given that the piezoelectric material of the piezoelectric valves can generate an electrical potential in response to forced movement, these external stimuli can be converted into energy. In some examples, a pump that is in a standby mode at the time of receiving the vibration can convert the external stimuli, for example in the form of vibrations, into energy.

[0046] As described above with respect to the example fluid architecture shown in FIG. 3, operation of the first pump P1 (with the first valve V1 open, the second pump P2 in standby mode, and the second valve V2 closed) creates a fluid flow in a first direction (from the inflatable member 104 to the reservoir 102) that causes the inflatable member 104 to deflate. Operation of the second pump P2 (with the second valve V2 open, the first pump P1 in standby mode, and the first valve closed) creates a fluid flow in a second direction (from the reservoir 102 to the inflatable member 104) that causes the inflatable member 104 to inflate. To maintain a set state (i.e., an inflated or deflated state) of the fluid-operated inflatable device 100, the first and second pumps P1, P2 are in standby mode and the first and second valves V1, V2 are closed.

[0047] In the example fluidic architecture shown in FIG. 3, at least one of the pumps P1, P2 is always in standby mode and can therefore be utilized to collect stimuli as described above and convert them into electrical displacements. In this example, one of the pumps P1 or P2 (the pump in operation) functions as an energy actuator or energy generator, and the other of the pumps P1 or P2 (the pump in standby mode) functions as an energy harvester or energy collector. If the pumps P1, P2 are piezoelectric pumps and the valves V1, V2 are piezoelectric valves, the example fluidic architecture shown in FIG. 3 can include as many as four piezoelectric elements. However, in this example, the pumps P1, P2 function as actuators and harvesters so that the latching and / or sealing capabilities of the valves V1, V2 are not compromised during operation of the fluid-operated inflatable device 100.

[0048] As described above, during operation of the device 100 in the inflation mode, vibrations generated due to the operation of the first pump P1 can be transferred from the first pump P1 to the second pump P2, for example through a manifold in which the fluidic architecture is housed. In this scenario, the piezoelectric element of the second pump P2 (in standby mode) is ready to capture energy generated by the vibrations generated as the piezoelectric element of the second pump P2 moves. Also, in some circumstances, hydraulic pressure acts on the second pump P2, thus contributing to the amplitude of the movement generated by the piezoelectric element of the second pump P2, and this amplified movement generates additional energy. During operation in the inflation mode, when the second pump P2 is operating and the first pump P1 is in standby mode, the second pump P2 operates to transfer fluid from the reservoir 102 to the inflatable member 104, and the first pump P1 captures the energy generated as a result of the operation of the second pump P2. In some circumstances, the physical movement of the user can cause the movement of the piezoelectric elements of the pumps P1, P2. The first pump P1 and / or the second pump P2 may also incorporate this movement when in standby mode.

[0049] Such energy capture and storage converts energy that would otherwise be dissipated and unused through the device 100. Thus, such energy capture and storage can extend the life of the power storage device 130 and increase the operating time of the fluid-actuated device 100 without recharging or replacing the power source. This can also allow for the use of a smaller power storage device 130, thereby reducing the overall size of the electronic fluid control system 400.

[0050] As mentioned above, in some examples, the fluid-actuated inflatable device 100 (e.g., in the form of the artificial urinary sphincter 100A or the inflatable penile prosthesis 100B described above) can be electronically controlled by an electronic control system 108. The electronic control system 108 can communicate with an external controller 120 that can be operated by, for example, a user. The external controller 120 can receive user inputs for controlling the fluid-actuated inflatable device 100 and transmit the user inputs to the electronic control system 108. The electronic control system 108 can communicate information to the external controller 120 for consumption by the user, such as, for example, the operating status, system alerts, and operating conditions of the device. Fast and reliable communication between the external controller 120 and the electronic control system 108 facilitates the correct functioning and operation of the device 100 under different conditions, providing comfort and ease of use to the patient during the life of the fluid-actuated inflatable device 100. Fast and reliable communication between the external controller 120 and the electronic control system 108 can enhance patient safety and enable the fluid-actuated inflatable device 100 to adapt to changing conditions and employ fail-safe measures with or without patient and / or physician intervention.

[0051] In some examples, the external controller 120 comprises a fob specially tailored for controlling, monitoring, and interacting with the fluid-actuated inflatable device 100. In some examples, the external controller 120 may be incorporated into an external electronic device capable of communicating with the electronic control system 108 of the fluid-actuated inflatable device 100. For example, the external controller 120 may be implemented in an application executed by an electronic device such as a smart phone or tablet computing device.

[0052] In some circumstances, communication between the external controller 120 and the electronic control system 108 of the fluid-actuated inflatable device 100 may be initiated by the patient, and changes to the operation and control of the fluid-actuated inflatable device 100 may be manually initiated. In some circumstances, the electronic control of the fluid-actuated inflatable device 100 is performed automatically under the control of the electronic control system 108.

[0053] In some examples, manual control of the fluid-actuated inflatable device 100 may allow for manual configuration of settings by the patient. For example, in some situations, the patient may find that increasing or decreasing the pressure of the inflatable member 104 provides increased comfort and / or maneuverability and / or safety. For example, in the case of the example artificial urinary sphincter 100A, the patient may use the external controller 120 to configure the pressure setting of the inflatable cuff 104A based on observed device performance, physical activity, etc. For example, the patient may use the external controller 120 to increase the occlusion pressure setting of the inflatable cuff 104A if they experience slight incontinence at the current setting. In some examples, the patient may wish to adjust the pressure setting of the inflatable cuff 104A because a particular physical activity may be affecting their incontinence (e.g., temporarily during the physical activity) and may use the external controller 120 to set the adjusted occlusion pressure of the inflatable cuff 104A for a set period of time and allow the device 100 to return to the previously stored setting after the set period has elapsed.

[0054] In some examples, the manual control of the fluid-operated inflatable device 100 can be activated by sub-audible signaling from the patient. In some examples, the sub-audible signaling can be detected by the external controller 120 and sent to the electronic control system 108 for control of the fluid-operated inflatable device 100. In some examples, the audible signaling can be detected by the electronic control system 108. In some examples, the manual control of the fluid-operated inflatable device 100 can be activated in response to a pressure spike detected due to tapping, such as continuous tapping performed by the patient and detected by the fluid-operated inflatable device 100. In situations where the patient is unable to use the external controller 120 for any reason (e.g., misplaced, uncharged, inoperable, etc.), the fluid-operated inflatable device 100 can adjust the pressure of the inflatable member 104, etc. in response to the sub-audible signaling from the patient. This can increase the safety and comfort of the patient.

[0055] In some examples, a configurable number of taps, for example, on the patient's torso, at or near the implantation site of the fluid-actuated inflatable device, or other locations, can define a unique sequence or pattern that triggers manual control of the fluid-actuated inflatable device 100. This unique sequence or pattern can prevent accidental activation of the fluid-actuated inflatable device 100 due to unintentional taps being detected by the device 100. In some examples, a piezoelectric element in a pump or valve can function as a microphone that can detect a set audible or sub-audible signal. In some examples, the detected signal can, for example, command the pump or valve to open, generating a current whose corresponding displacement can be measured.

[0056] In some examples, one or both of the implantable fluid-actuated inflatable device 100 and / or the external controller 120 include a motion detection device, such as an accelerometer, capable of detecting a motion event. In some circumstances, a motion event can cause a change in state within the fluid-actuated inflatable device 100 that can benefit from adapting the operating parameters of the device 100 to the motion event. For example, in the artificial urinary sphincter 100A described above, motion related to events such as coughing, sneezing, lifting, and exercise / physical activity can cause incontinence. When the accelerometer detects this type of motion event, it can trigger a processor or the like of the electronic control system 108 to execute an algorithm that increases the pressure of the inflatable cuff 104A during the motion event to provide additional pressure to the urethra to prevent incontinence. In some examples, the need for additional pressure in the inflatable member 104 or the like in response to these types of motion events can be detected based on pressure changes / pressure fluctuations detected by a sensing device included in the fluidic architecture. For example, a detected increase in intra-abdominal pressure (e.g., due to squeezing, bending and / or lifting movements from a cough or sneeze, etc.) can be communicated to the reservoir 102, thus increasing the internal pressure of the device 100 in the reservoir 102. An increase in pressure in the reservoir 102 detected by one of the sensing devices can be processed by an algorithm executed by the electronic control system to adjust the operation of the pumps and valves in the fluid system to apply an appropriate pressure to the reservoir 102 and the inflatable member 104 to maintain the current state of the fluid-actuated inflatable device 100.

[0057] In some examples, manual control of the fluid-actuated inflatable device 100 in situations where the external controller 120 is unavailable to the patient for any reason (misplaced, uncharged, inoperable, etc.) can be accomplished using a backup actuator, such as a magnet. For example, in a situation where the external controller is unavailable and the patient needs to relieve pressure on the inflatable cuff 104A of the artificial urinary sphincter 100A, the backup actuator / magnet can be applied at a location corresponding to the implantable device 100A to activate a reed switch that controls the pumps and valves in the fluidic architecture to relieve pressure on the inflatable cuff 104A, opening the inflatable cuff 104A and freeing the urethra.

[0058] In some examples, manual control of the fluid-actuated inflatable device 100 can include applying external manual pressure to the device 100, especially when the external controller 120 is unavailable. In some examples, this control can include a first sequence of externally applied pressure that acts as a wake-up signal, followed by a second sequence of externally applied pressure that acts as an activation signal. For example, pressure applied externally in the form of pulling on the penis can create pressure fluctuations in the fluid channels of the artificial urinary sphincter 100A, especially near the inflatable cuff 104A. In this example, the first pulling sequence can wake up the artificial urinary sphincter 100A, and the second pulling sequence can indicate the release of pressure on the inflatable cuff 104A, opening the cuff and freeing the urethra to allow the patient to urinate. In some examples, such pressure in the form of pulling can also generate a sub-audible signal that can be detected by the piezoelectric elements of the pumps and valves that act as microphones as described above.

[0059] As mentioned above, in some circumstances, electronic control of the fluid-actuated inflatable device is performed automatically under the control of electronic control system 108. This allows for substantially continuous system monitoring, diagnosis and adjustment, and can output alerts in response to detection of conditions requiring intervention by the patient and / or physician.

[0060] In some examples, the electronic control system 108 can monitor the operation of the fluid-actuated inflatable device 100 to detect conditions that may indicate leaks, blockages, and the like that may jeopardize the operation of the device 100 and / or lead to failure of the device 100. For example, the electronic control system 108 can monitor the time to reach a particular pressure at a particular location in the fluid architecture. For example, a change in pumping time above a set threshold or range and / or an inability to reach a certain pressure or range of pressures may indicate a leak or blockage in a fluid channel of the fluid-actuated inflatable device 100. In some examples, the electronic control system 108 generates an alert to be output, for example, through the external controller 120, to warn the patient and / or physician of a potential condition that may jeopardize the operation of the device 100 and / or lead to failure of the device 100. In some examples, the electronic control system 108 can control the operation of pumps and valves to seal the fluid in the portions of the device 100 that are not leaking.

[0061] In some examples, the automated control of the fluid-actuated inflatable device 100 includes collecting and storing data for diagnosis and adjustment of patient care protocols by a physician. In the case of the artificial urinary sphincter 100A, diagnosis often relies on a bladder diary that is manually completed by the patient. In some examples, the electronic control system 108 of the artificial urinary sphincter 100A can measure and record the number of times the patient must urinate per day, the time from start to finish of each urination event, and other such data. In some examples, the elapsed time of each urination event can be determined based on the time the inflatable cuff 104A is open and / or the time the inflatable cuff 104A is closed. In some examples, the acoustic properties of the piezoelectric elements of the pump and / or valves can be used to calculate the start and end times of each urination event. The data collected and tracked in this manner can be used by a physician for subsequent diagnosis and treatment.

[0062] In some examples, automatic control of the fluid-actuated inflatable device 100 includes automatically controlling the pressure of the inflatable member 104 and / or the reservoir 102 in response to certain conditions. For example, the electronic control system 108 may detect that there has been no communication from the external controller 120 to the implantable fluid-actuated inflatable device 100 for a set period of time (indicating that the external controller 120 is unavailable or inoperable for some reason) and / or that the inflatable member 104 has remained in an inflated state for longer than a set period of time, etc. In response to detecting such conditions, the electronic control system 108 may, for example, relax the pressure setting within the implantable fluid-actuated inflatable device 100 as a fail-safe measure to relieve the pressure in the inflatable member 104.

[0063] In some examples, automated control of the fluid-actuated inflatable device 100 can enable detection of infection. A sensing device, such as one or more thermocouples, within the device 100 can record temperatures indicative of the patient's internal body temperature. These temperatures can be stored, for example, in memory of the electronic control system 108. The sensed temperatures, as well as fluctuations and / or increases in the sensed temperatures, can provide early infection indicators. In some examples, this early infection prediction can trigger an alert to be output to the user via the external controller 120 for treatment by a physician.

[0064] In some examples, automatic control of the fluid-actuated inflatable device 100 may enable correction of the internal device pressure based on atmospheric pressure or air pressure detected by an external device, such as the external controller 120, and transmitted to the electronic control system 108. Identification of the atmospheric pressure (and changes in atmospheric pressure), performed essentially in real time in some examples, may enable the electronic control system 108 to automatically control operation of pumps and valves to adjust the internal pressure of the device 100 based on the detected atmospheric pressure. The ability to automatically adjust device operation to account for changes in atmospheric pressure may ensure that the implantable fluid-actuated inflatable device 100 maintains the correct internal pressure even as atmospheric conditions change.

[0065] The example implantable fluid-actuated inflatable device 100 described above (e.g., in the form of an artificial urinary sphincter 100A and / or an inflatable penile prosthesis 100B) includes a fluid reservoir 102 connected to an inflatable member 104 by an electronic fluid control system 400 via fluid conduits 103, 105 to allow transfer of fluid between the reservoir 102 and the inflatable member 104. Figures 12A-12C show an example implantable fluid-actuated inflatable device in which the fluid reservoir is coupled to the housing of the electronic fluid control system. Figures 13A and 13B show an example implantable fluid-actuated inflatable device in which the fluid reservoir is contained within the housing of the electronic fluid control system.

[0066] 12A-12C are schematic diagrams of example implantable fluid-actuated inflatable devices 600. Specifically, FIG. 12A is a schematic diagram of a first example implantable fluid-actuated inflatable device 600A, FIG. 12B is a schematic diagram of a second example implantable fluid-actuated inflatable device 600B, and FIG. 12C is a schematic diagram of a third example implantable fluid-actuated inflatable device 600C. Each of the three example fluid-actuated inflatable devices 600A, 600B, 600C shown in FIG. 12A-12C includes an inflatable member 604 coupled to an electronic fluid control system 640 by a fluid conduit 605 and a fluid reservoir 602 coupled, e.g., directly, to a housing 610 of the electronic fluid control system 640.

[0067] The example electronic fluid control system 640 may include components included in the example electronic fluid control system 400 described above with respect to Figures 5-11, including, for example, the power storage device 130, the PCB 140 of the electronic control system 108, and the fluid control system 106 including an example fluid architecture contained within the housing 110, as described above with respect to Figures 5-11. The principles described with respect to the example implantable fluid-actuated inflatable devices 600A, 600B, 600C may be applied to a variety of different types of implantable fluid-actuated inflatable devices, including, for example, the artificial urinary sphincter 100A and inflatable penile prosthesis 100B described above.

[0068] The example fluid-actuated inflatable device 600A shown in FIG. 12A includes an electronic fluid control system 640 including electronic and fluid components as described above housed within a hermetic housing 610. A fluid conduit 605 has a first end coupled to the inflatable member 604 and a second end passing through a port 620 formed in the housing 610 to connect to the fluid control system housed within the housing 610 to allow transfer of fluid to and from the inflatable member 704. In the arrangement shown in FIG. 12A, a reservoir 602A is coupled to a top portion of the hermetic housing 610 or to a cross section of the hermetic housing 610 (in the example orientation shown in FIG. 12A). In some examples, the reservoir 602A is fixed, e.g., glued or bonded, to the housing 610. The fluid conduit 603A has a first end connected to the reservoir 602A and a second end that passes through a port 630A in the housing 610 to connect to a fluid control system contained within the housing 610 to allow transfer of fluid to and from the reservoir 602A. This arrangement can exhibit a small mating surface area between the sealed housing 610 and the reservoir 602A, which can reduce pressure on the reservoir 602A due to patient movement (e.g., compared to the arrangement shown in FIG. 12B). In some examples, a lattice (not shown in FIG. 12A) can be placed around the outside of the reservoir 602A to prevent external pressure from being applied to the reservoir 602A.

[0069] The example fluid-operated inflatable device 600B shown in FIG. 12B includes an electronic fluid control system 640 including an inflatable member 604 connected via a fluid conduit 605 as described above to a fluid control system contained within a hermetic housing 610. The example fluid-operated inflatable device 600B includes a reservoir 602B coupled to a side of the hermetic housing 610 or to a coronal plane of the housing 610 (in the orientation shown in FIG. 12B). In some examples, the reservoir 602B is fixed to the housing 610, e.g., glued or bonded. A conduit 603B has a first end connected to the reservoir 602B and a second end that passes through a port 630B in the housing 610 to connect to a fluid control system contained within the housing 610 to allow transfer of fluid to and from the reservoir 602B. In the arrangement shown in FIG. 12B, the reservoir 602B is coupled to the widest surface of the housing 610. The increased surface area of ​​reservoir 602B may result in a reduced expansion requirement for reservoir 602B (compared to the exemplary arrangement shown in FIG. 12A).

[0070] The example fluid-operated inflatable device 600C shown in FIG. 12C includes an electronic fluid control system 640 including an inflatable member 604 connected to a fluid control system housed within a sealed housing 610 via a fluid conduit 605 as described above. The example fluid-operated inflatable device 600C includes a reservoir 602C having a bellows structure coupled to the top of the sealed housing 610 (in the example orientation shown in FIG. 12C). In some examples, a portion of the reservoir 602C, such as a bottom portion, is secured to the housing 610, e.g., glued or bonded, to allow for the expansion and contraction of the remaining portion of the bellows structure forming the reservoir 602C. A conduit 603C has a first end connected to the reservoir 602C and a second end passing through a port 630C in the housing 610 for connection to a fluid control system housed within the housing 610 to allow for the transfer of fluid to and from the reservoir 602C. The bellows structure of the example reservoir 602C shown in Figure 12C contracts when fluid is expelled from the reservoir 602C and expands when fluid is introduced into the reservoir 602C. The bellows structure of the example reservoir 602C shown in Figure 12C allows a wide range of materials to be used for the reservoir 602C, including, for example, titanium polymetric materials, allowing the reservoir 602C to be sealed in a sealed housing 610. In some examples, a lattice (not shown in Figure 12C) can be placed around the outside of the reservoir 602C to prevent external pressure from being applied to the reservoir 602C.

[0071] The example two-piece fluid-actuated inflatable device 600A, 600B, 600C, including an external fluid reservoir 602A, 602B, 602C attached to a hermetic housing 610, allows for limited resistance to inflation and deflation of the reservoir 602A, 602B, 602C outside of the hermetic housing 610, while reducing the overall device 600 to two components (i.e., the inflatable member 604 and the housing 610 with the reservoir 602 attached). In some circumstances, this design reduces surgical time and complexity. In some circumstances, this design allows the hermetic housing 610 to be sutured in place within the patient, thus limiting in-vivo drift over the life of the implantable fluid-actuated inflatable device 600.

[0072] 13A and 13B are schematic diagrams of example implantable fluid-actuated inflatable devices 700. Specifically, FIG. 13A is a schematic diagram of a first example implantable fluid-actuated inflatable device 700A, and FIG. 13B is a schematic diagram of a second example implantable fluid-actuated inflatable device 700B. Each of the example fluid-actuated inflatable devices 700A, 700B shown in FIG. 13A and 13B includes an inflatable member 704 coupled to an electronic fluid control system 740 by a fluid conduit 705, and a fluid reservoir 702 contained within a sealed housing 710 of the electronic fluid control system 740.

[0073] The example electronic fluid control system 740 may include components included in the example electronic fluid control system 400 described above with respect to Figures 5-11, including, for example, the power storage device 130, the PCB 140 of the electronic control system 108, and the fluid control system 106 including an example fluid architecture contained within the housing 110, as described above with respect to Figures 5-11. The principles described with respect to the example implantable fluid-actuated inflatable devices 700A and 700B may be applied to a variety of different types of implantable fluid-actuated inflatable devices, including, for example, the artificial urinary sphincter 100A and inflatable penile prosthesis 100B described above.

[0074] The example fluid-actuated inflatable device 700A shown in FIG. 12A includes an electronic fluid control system 740 including electronic and fluid components as described above housed within a hermetic housing 710. A fluid conduit 705 has a first end coupled to the inflatable member 704 and a second end passing through a port 720 formed in the housing 710 to connect to the fluid control system housed within the housing 710 and allow for the transfer of fluid to and from the inflatable member 704. In the arrangement shown in FIG. 13A, a reservoir 702A is housed within the hermetic housing 710. Because the environment within the hermetic housing 710 holds a constant amount of gas / fluid, any change in volume within the reservoir 702 will result in a change in pressure within the hermetic housing 710, limiting the amount by which the reservoir 702 can expand and contract within the hermetic housing 710. The use of a bellows structure for the reservoir 702 can alleviate this limitation, especially if the hermetic housing 710 is filled with a gas that is relatively easy to compress, such as helium or argon.

[0075] 12B includes a closed bellows 712 in a sealed housing 710. The closed bellows 712 may be filled with a compressible fluid acting as a sacrificial gas such that the reservoir 702 contracts and the closed bellows 712 expands, and the reservoir 702 expands and the closed bellows 712 contracts. That is, the reservoir 702 (having a bellows structure) expands when fluid is introduced into the reservoir 702, and the closed bellows 712 contracts in response to the reservoir 702 expansion. The reservoir 702 contracts when fluid is discharged from the reservoir 702, and the closed bellows 712 expands in response to the reservoir 702 contraction.

[0076] The exemplary two-piece fluid-actuated inflatable device 700A, 700B, including an internal fluid reservoir 702 mounted within a hermetic housing 610, can reduce the overall size of the implantable fluid-actuated inflatable device 700. In some circumstances, this design can reduce surgical time and complexity. In some circumstances, this design can allow the hermetic housing 710 to be sutured into place within the patient, thus reducing in vivo drift over the life of the implantable fluid-actuated inflatable device 700.

[0077] While certain features of the described implementations have been described herein, many modifications, substitutions, changes and equivalents will occur to those skilled in the art, and it is therefore to be understood that the appended claims are intended to cover all such modifications and changes that are within the scope of the present embodiments. [Explanation of symbols]

[0078] 102 Reservoir 104 Expandable member 106 Fluid Control System 108 Electronic Control System 120 External Controller

Claims

1. 1. An implantable fluid-actuated inflatable device, comprising: A fluid reservoir; and An inflatable member; an electronic fluid control system coupled between the fluid reservoir and the inflatable member and configured to control fluid between the fluid reservoir and the inflatable member; The electronic fluid control system comprises: Housing and a fluid control system contained within the housing, the fluid architecture including at least one pump device disposed within a fluid passage within the housing; an electronic control system contained within the housing; The electronic control system includes: at least one processor configured to control operation of the at least one pump device; a communications module configured to receive at least one external input; Including, and at least one pressure sensing device configured to sense a fluid pressure within the implantable fluid-actuated inflatable device and transmit the sensed pressure to the electronic control system. The fluid architecture comprises: a first one-way pump and a first passive valve disposed in the first fluid passageway for selectively generating and controlling fluid flow in a first direction from the inflatable member toward the reservoir; a second one-way pump and a second passive valve disposed in the second fluid passageway for selectively generating and controlling fluid flow in a second direction from the reservoir toward the inflatable member; a first sensing device positioned to sense fluid pressure in the reservoir; a second sensing device positioned to sense fluid pressure in the inflatable member; an active valve disposed along the inflatable member; Including, in a first mode, the active valve is configured to be closed by the electronic control system to prevent deflation of the inflatable member in response to detection of a pressure spike in the inflatable member; An implantable fluid-actuated inflatable device, wherein in a second mode, the active valve is configured to be opened by the electronic control system to allow deflation of the inflatable member in response to detection of a loss of power to the electronic fluid control system.

2. The implantable fluid-actuated inflatable device of claim 1 , wherein the reservoir is coupled to an exterior surface of the housing.

3. 10. The implantable fluid-actuated inflatable device of claim 1, wherein the reservoir includes a bellows structure configured to contract as fluid is expelled from the reservoir and to expand as fluid is drawn into the reservoir.

4. the reservoir is contained within the housing and includes a bellows structure configured to contract as fluid is expelled from the reservoir and to expand as fluid is introduced into the reservoir; 4. The implantable fluid-operated inflatable device of claim 3, further comprising a closed bellows within the housing, the closed bellows filled with a compressible fluid so as to be configured to contract in response to an expansion of the reservoir and to expand in response to a contraction of the reservoir.

5. The implantable fluid-actuated inflatable device of any one of claims 1 to 4, wherein the electronic control system is configured to receive the at least one external input from an external device and to control operation of the at least one pump device in response to the received user input.

6. 6. The implantable fluid-operated inflatable device of claim 5, wherein the electronic control system is configured to adjust operation of the at least one pump device to reduce pressure in the inflatable member and initiate deflation of the inflatable member in response to detection of a signal generated by interaction of the electronic control system with a magnet positioned corresponding to the fluid-operated inflatable device for a predetermined period of time.

7. The electronic control system includes: a change in pressure detected by the at least one sensing device in response to a tapping or tagging input; or a motion event detected by a motion detection device of the fluid-operated inflatable device or an external device; 13. The implantable fluid-actuated inflatable device of claim 1, configured to control operation of the at least one pump device in response to a user input comprising at least one of:

8. 8. The implantable fluid-actuated inflatable device of claim 7, wherein the external input comprises a series of taps in a preset sequence sensed by a piezoelectric element of the at least one pump device.

9. The preset sequence includes: a wake-up sequence for waking up the fluid-operated inflatable device, the wake-up sequence including a first tapping sequence defined by a first number of taps in a first pattern; an actuation sequence responsive to the user input including a second tapping sequence defined by a second number of taps in a second pattern; 9. The implantable fluid-actuated inflatable device of claim 8, comprising:

10. The electronic control system monitors the pressure level within the fluid-operated inflatable device and, in response to detected pressure fluctuations, controlling the at least one pump device to reduce pressure in the inflatable member to deflate the inflatable member in response to detecting that the inflatable member is inflated for longer than a preset period of time; in response to detecting an increase or decrease in pressure having a duration less than a preset period, controlling the at least one pump device to maintain a current state of the fluid-operated inflatable device; controlling the at least one pump device to maintain a current state of the fluid-operated inflatable device in response to detecting a change in atmospheric conditions; 10. The implantable fluid-actuated inflatable device of claim 1, configured to control the operation of the at least one pump device, the at least one pump device comprising:

11. The electronic control system includes: detecting a failure of the fluid-operated inflatable device in response to detecting that the time to reach a set pressure exceeds a set period of time or that the set pressure cannot be reached; outputting an alert about the detected fault to an external device; isolating fluid from the area of ​​the detected fault; 2. The implantable fluid-actuated inflatable device of claim 1 , configured as follows:

12. the at least one pump device includes a first piezoelectric pump in a first fluid channel of the fluidic architecture and a second piezoelectric pump in a second fluid channel of the fluidic architecture; In contraction mode, the first piezoelectric pump is configured to operate to pump fluid from the inflatable member to the reservoir while the second piezoelectric pump is in a standby mode; vibrations generated by operation of the first piezoelectric pump are captured for conversion into energy by the second piezoelectric pump in the standby mode; In the inflation mode, the second piezoelectric pump is configured to operate to pump fluid from the reservoir to the inflatable member while the first piezoelectric pump is in a standby mode; vibrations generated by operation of the second piezoelectric pump are captured for conversion into energy by the first piezoelectric pump in the standby mode; In a standby mode of the fluid-operated inflatable device, the first piezoelectric pump and the second piezoelectric pump are both in the standby mode, An implantable fluid-operated inflatable device as described in any one of claims 1 to 11, wherein vibrations generated by movement of a patient in which the fluid-operated inflatable device is implanted are captured by the first piezoelectric pump and the second piezoelectric pump for conversion into energy.

13. The fluid architecture comprises: a first unidirectional pump disposed in the first fluid passage and configured to generate a fluid flow in a first direction from the inflatable member toward the reservoir; a second one-way pump disposed in the second fluid passageway and configured to generate a fluid flow in a second direction from the reservoir toward the inflatable member; a first passive valve disposed in the first fluid passage between the first one-way pump and the reservoir to restrict fluid flow in the first direction in the first fluid passage and to prevent backflow of fluid in the first fluid passage while the second one-way pump is in an operating mode and the first one-way pump is in a standby mode; a second passive valve disposed in the second fluid passage between the second one-way pump and the reservoir to restrict fluid flow in the second direction in the second fluid passage and to prevent backflow of fluid in the second fluid passage while the first one-way pump is in an operating mode and the second one-way pump is in a standby mode; a first sensing device positioned to sense fluid pressure in the reservoir; a second sensing device positioned to sense fluid pressure in the inflatable member; 13. The implantable fluid-actuated inflatable device of claim 1, comprising:

14. The fluid architecture comprises: a first combination pump and valve device disposed within the first fluid passageway to selectively generate and control fluid flow in a first direction from the inflatable member toward the reservoir; a first sensing device positioned to sense fluid pressure in the reservoir; a second combination pump and valve apparatus disposed in the second fluid passageway for selectively generating and controlling fluid flow in a second direction from the reservoir toward the inflatable member; a second sensing device positioned to sense fluid pressure in the inflatable member; 13. The implantable fluid-actuated inflatable device of claim 1, comprising:

15. 1. An implantable fluid-actuated inflatable device, comprising: A fluid reservoir; and An inflatable member; an electronic fluid control system coupled between the fluid reservoir and the inflatable member and configured to control fluid between the fluid reservoir and the inflatable member; The electronic fluid control system comprises: Housing and a fluid control system contained within the housing, the fluid architecture including a pump device disposed within a fluid passage within the housing; an electronic control system contained within the housing; The electronic control system includes: at least one processor configured to control operation of the at least one pump and at least one valve; a communication module configured to communicate with at least one external device; Including, and at least one pressure sensing device configured to sense a fluid pressure within the implantable fluid-actuated inflatable device and transmit the sensed pressure to the electronic control system. The electronic control system monitors the pressure level within the fluid-operated inflatable device and, in response to detected pressure fluctuations, controlling the at least one pump device to reduce pressure in the inflatable member to deflate the inflatable member in response to detecting that the inflatable member is inflated for longer than a preset period of time; in response to detecting a pressure spike having a duration less than a preset period, controlling the at least one pump device to maintain a current state of the fluid-operated inflatable device; controlling the at least one pump device to maintain a current state of the fluid-operated inflatable device in response to detecting a change in atmospheric conditions; 13. An implantable fluid-actuated inflatable device configured to control operation of the at least one pump device, comprising:

16. The implantable fluid-actuated inflatable device of claim 15 , wherein the reservoir is coupled to an exterior surface of the housing.

17. 16. The implantable fluid-actuated inflatable device of claim 15, wherein the reservoir includes a bellows structure configured to contract as fluid is expelled from the reservoir and to expand as fluid is filled into the reservoir.

18. 20. The implantable fluid-actuated inflatable device of claim 17, wherein the reservoir is contained within the housing.

19. 20. The implantable fluid-actuated inflatable device of claim 18, further comprising a closed bellows within the housing, the closed bellows filled with a compressible fluid configured to contract in response to an expansion of the reservoir and to expand in response to a contraction of the reservoir.

20. 16. The implantable fluid-actuated inflatable device of claim 15, wherein the electronic control system is configured to receive user input from the external device and to control operation of the at least one pump device in response to the received user input.

21. 21. The implantable fluid-operated inflatable device of claim 20, wherein the electronic control system is configured to adjust operation of the at least one pump device to reduce pressure in the inflatable member and initiate deflation of the inflatable member in response to detection of a signal generated by interaction of the electronic control system with a magnet positioned corresponding to the fluid-operated inflatable device for a preset period of time.

22. The electronic control system includes: a change in pressure detected by the at least one sensing device in response to a tapping or tagging input; or a motion event detected by a motion detection device of the fluid-actuated inflatable device or the external device; 16. The implantable fluid-actuated inflatable device of claim 15, configured to control operation of the at least one pump device in response to a user input comprising at least one of:

23. 23. The implantable fluid-actuated inflatable device of claim 22, wherein the tapping input comprises a series of taps in a preset sequence detected by a piezoelectric element of the at least one pump device.

24. The preset sequence includes: a wake-up sequence for waking up the fluid-operated inflatable device, the wake-up sequence including a first tapping sequence defined by a first number of taps in a first pattern; an actuation sequence responsive to the user input including a second tapping sequence defined by a second number of taps in a second pattern; 24. The implantable fluid-actuated inflatable device of claim 23, comprising:

25. The electronic control system includes: detecting a failure of the fluid-operated inflatable device in response to detecting that the time to reach a set pressure exceeds a set period of time or that the set pressure cannot be reached; outputting an alert about the detected fault to the external device; isolating the fluid from the area of ​​the detected fault; 16. The implantable fluid-actuated inflatable device of claim 15, configured as follows:

26. the at least one pump device includes a first piezoelectric pump in a first fluid channel of the fluidic architecture and a second piezoelectric pump in a second fluid channel of the fluidic architecture; In contraction mode, the first piezoelectric pump is configured to operate to pump fluid from the inflatable member to the reservoir while the second piezoelectric pump is in a standby mode; vibrations generated by operation of the first piezoelectric pump are captured for conversion into energy by the second piezoelectric pump in the standby mode; In the inflation mode, the second piezoelectric pump is configured to operate to pump fluid from the reservoir to the inflatable member while the first piezoelectric pump is in a standby mode; 16. The implantable fluid-actuated inflatable device of claim 15, wherein vibrations caused by operation of the second piezoelectric pump are captured for conversion to energy by the first piezoelectric pump in the standby mode.

27. In a standby mode of the fluid-operated inflatable device, the first piezoelectric pump and the second piezoelectric pump are both in the standby mode, 27. The implantable fluid-actuated inflatable device of claim 26, wherein vibrations caused by movement of a patient in which the fluid-actuated inflatable device is implanted are captured by the first piezoelectric pump and the second piezoelectric pump for conversion into energy.

28. The fluid architecture comprises: a first one-way pump and a first passive valve disposed in the first fluid passageway for selectively generating and controlling fluid flow in a first direction from the inflatable member toward the reservoir; a second one-way pump and a second passive valve disposed in the second fluid passageway for selectively generating and controlling fluid flow in a second direction from the reservoir toward the inflatable member; a first sensing device positioned to sense fluid pressure in the reservoir; a second sensing device positioned to sense fluid pressure in the inflatable member; an active valve disposed along the inflatable member; Including, in a first mode, the active valve is configured to be closed by the electronic control system to prevent deflation of the inflatable member in response to detection of a pressure spike in the inflatable member; 16. The implantable fluid-actuated inflatable device of claim 15, wherein in a second mode, the active valve is configured to be opened by the electronic control system to allow deflation of the inflatable member in response to detecting a loss of power to the electronic fluid control system.

29. The fluid architecture comprises: a first unidirectional pump disposed in the first fluid passage and configured to generate a fluid flow in a first direction from the inflatable member toward the reservoir; a second one-way pump disposed in the second fluid passageway and configured to generate a fluid flow in a second direction from the reservoir toward the inflatable member; a first passive valve disposed in the first fluid passage between the first one-way pump and the reservoir to restrict fluid flow in the first direction in the first fluid passage and to prevent backflow of fluid in the first fluid passage while the second one-way pump is in an operating mode and the first one-way pump is in a standby mode; a second passive valve disposed in the second fluid passage between the second one-way pump and the reservoir to restrict fluid flow in the second direction in the second fluid passage and to prevent backflow of fluid in the second fluid passage while the first one-way pump is in an operating mode and the second one-way pump is in a standby mode; a first sensing device positioned to sense fluid pressure in the reservoir; a second sensing device positioned to sense fluid pressure in the inflatable member; 16. The implantable fluid-actuated inflatable device of claim 15, comprising:

30. The fluid architecture comprises: a one-way pump disposed within the fluid passage; a first active valve disposed in the fluid passage between the pump and the reservoir and configured to be selectively actuated by the electronic control system; a second active valve disposed in the fluid passage between the pump and the inflatable member and configured to be selectively actuated by the electronic control system; a third active valve disposed in the fluid passage between the pump and the reservoir and configured to be selectively actuated by the electronic control system; and a fourth active valve disposed in the fluid passage between the pump and the inflatable member and configured to be selectively actuated by the electronic control system; Including, in an inflation mode, the first active valve and the second active valve are opened by the electronic control system, and the third active valve and the fourth active valve are closed by the electronic control system to pump fluid from the reservoir to the inflatable member; 16. The implantable fluid-actuated inflatable device of claim 15, wherein in a deflation mode, the electronic control system opens the third active valve and the fourth active valve and the electronic control system closes the first active valve and the second active valve, thereby pumping fluid from the inflatable member to the reservoir.

31. The fluid architecture comprises: a first combination pump and valve device disposed within the first fluid passageway to selectively generate and control fluid flow in a first direction from the inflatable member toward the reservoir; a first sensing device positioned to sense fluid pressure in the reservoir; a second combination pump and valve apparatus disposed in the second fluid passageway for selectively generating and controlling fluid flow in a second direction from the reservoir toward the inflatable member; a second sensing device positioned to sense fluid pressure in the inflatable member; 16. The implantable fluid-actuated inflatable device of claim 15, comprising:

32. The fluid architecture comprises: a first piezoelectric pump and valve device disposed in the first fluid passageway and configured to selectively generate and control a fluid flow in a first direction from the inflatable member toward the reservoir and to sense fluid pressure in the reservoir; a second piezoelectric pump and valve device disposed in the second fluid passageway and configured to selectively generate and control a fluid flow in a second direction from the reservoir toward the inflatable member and to sense fluid pressure in the inflatable member; and 16. The implantable fluid-actuated inflatable device of claim 15, comprising:

33. The fluid architecture comprises: A pump, a first three-way valve disposed between the pump and the reservoir, the first three-way valve having a first port that opens to maintain fluid communication with the pump; a second three-way valve disposed between the pump and the inflatable member, the second three-way valve having a first port that opens to maintain fluid communication with the pump; Including, In contraction mode, a second port of the first three-way valve is open and a third port of the first three-way valve is closed to direct fluid flow from the first port to the second port of the first three-way valve; a second port of the second three-way valve is open and a third port of the second three-way valve is closed to direct fluid flow from the first port to the second port of the second three-way valve; In the inflation mode, the second port of the first three-way valve is closed and the third port of the first three-way valve is open to direct fluid flow from the first port to the third port of the first three-way valve; 16. The implantable fluid-actuated inflatable device of claim 15, wherein the second port of the second three-way valve is closed and the third port of the second three-way valve is open to direct fluid flow from the first port to the third port of the second three-way valve.

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