CN116981428A - Fluid control system for an implantable inflatable device - Google Patents

Abstract

An implantable fluid-operated device may include a fluid reservoir configured to contain a fluid, an expandable member, and a pump assembly configured to transfer the fluid between the fluid reservoir and the expandable member. The pump assembly may include one or more fluid pumps and one or more valves. The electronic control system may control operation of the pump assembly based on fluid pressure measurements and/or fluid flow measurements received from the one or more sensing devices. The electronic control system may include an internal component mounted with the implant device and an external component operable by a user to provide user input and receive output from the implant device.

Description

Fluid control system for an implantable inflatable device

Cross Reference to Related Applications

The present application is a continuation of, and claims priority to, U.S. non-provisional patent application Ser. No. 17/655,958 entitled "FLUID CONTROL SYSTEM FOR AN IMPLANTABLE INFLATABLE DEVICE" filed on 3 month 22 of 2022, which claims priority to U.S. provisional patent application Ser. No. 63/200,739 entitled "FLUID CONTROL SYSTEM FOR AN IMPLANTABLE INFLATABLE DEVICE" filed on 25 month 3 of 2021, the disclosure of which is incorporated herein by reference in its entirety.

The present application also claims priority from U.S. provisional patent application No. 63/200,739 filed on 3/25 of 2021, the disclosure of which is incorporated herein by reference in its entirety.

Technical Field

The present disclosure relates generally to body implants, and more particularly to body implants including pumps.

Background

Active implantable fluid-operated devices typically include one or more pumps that regulate the flow of fluid between different portions of the implantable device. One or more valves may be positioned within the fluid pathway of the device to direct and control the flow of fluid in order to effect inflation, deflation, pressurization, depressurization, activation, deactivation, etc. of the different fluid-filled implant components of the device. In some implantable fluid-operated devices, a sensor may be used to monitor the fluid pressure and/or fluid volume within the fluid passageway of the device. Accurate monitoring of the internal conditions of the device, including pressure monitoring and flow monitoring, may provide for improved control of the operation of the device, improved diagnostics, and improved device efficacy. Additionally, sensors may be used to monitor conditions external to the device, including acceleration, angle, barometric pressure, and temperature, which may facilitate determining an operational mode of the device.

Disclosure of Invention

In general, an implantable fluid-operated inflatable device includes: a fluid reservoir; an inflatable member; and an electronic fluid control system coupled between the fluid reservoir and the expandable member and configured to control fluid between the fluid reservoir and the expandable member. The electronic fluid control system may include a housing; a fluid control system housed in the housing, the fluid control system comprising a fluidic architecture including at least one valve and at least one pump positioned in a fluid passageway within the housing; and an electronic control system contained in the housing, the electronic control system comprising 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-operated inflatable device may further comprise: at least one pressure sensing device configured to sense a fluid pressure in the implantable fluid-operated inflatable device and communicate the sensed pressure to the electronic control system.

In some embodiments, the reservoir is bonded to an outer surface of the housing. In some embodiments, the reservoir includes a bellows structure configured to contract as fluid is expelled from the reservoir and expand as fluid flows into the reservoir. In some embodiments, the reservoir is contained within the housing. In some embodiments, a bellows structure is provided within the housing, wherein the closed bellows is filled with a compressible fluid such that the closed bellows is configured to contract in response to expansion of the reservoir and expand in response to contraction of the reservoir.

In some embodiments, the electronic control system is configured to receive at least one external input from an external device and to control operation of the at least one pump and the at least one valve in response to the received user input. In some embodiments, the electronic control system is configured to adjust operation of the at least one pump and the at least one valve to reduce pressure at the inflatable member and initiate deflation of the inflatable member in response to detecting a signal generated by interaction of a magnet positioned corresponding to the fluid-controlled inflatable device for a preset period of time. In some embodiments, the electronic control system is configured to control operation of the at least one pump and the at least one valve in response to user input including at least one of: pressure fluctuations detected by at least one sensing device in response to a tap input or a pull input; or a motion event detected by a motion detection device of the fluid operated inflatable device or an external device. The tap input may comprise a series of taps in a preset sequence detected by the piezoelectric element of the at least one pump or the at least one valve. The preset sequence may include: a wake-up sequence to wake up the fluid operated inflatable device comprising a first sequence of taps defined by a first number of taps in a first mode; and an activation sequence corresponding to the user input including a second sequence of taps defined by a second number of taps in a second mode.

In some embodiments, the electronic control system is configured to monitor a pressure level in the fluid-controlled inflatable device and to control operation of the at least one pump and the at least one valve in response to detected pressure fluctuations, comprising: in response to detecting that the expandable member is in the expanded state for more than a preset period of time, controlling the at least one pump and the at least one valve to reduce the pressure at the expandable member and deflate the expandable member; in response to detecting an increase or decrease in pressure having a duration less than a preset period of time, controlling at least one pump and at least one valve to maintain a current state of the fluid-controlled inflatable device; and in response to detecting the change in atmospheric conditions, controlling the at least one pump and the at least one valve to maintain a current state of the fluid-controlled inflatable device.

In some embodiments, the electronic control system is configured to: detecting a fault in the fluid-controlled inflatable device in response to detecting that the set pressure is reached for more than a set period of time or that the set pressure is not reached; outputting an alarm of the detected failure to an external device; and isolating the fluid from the region where the fault was detected.

In some embodiments, the at least one pump comprises 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 the compact mode, the first piezoelectric pump configured to operate to pump fluid from the expandable member to the reservoir while the second piezoelectric pump is in the standby mode; and vibrations generated by operation of the first piezoelectric pump are harvested by the second piezoelectric pump in a standby mode for conversion into energy; and in the expansion mode, the second piezoelectric pump is configured to operate to pump fluid from the reservoir to the expandable member while the first piezoelectric pump is in the standby mode; and vibrations generated by operation of the second piezoelectric pump are harvested by the first piezoelectric pump in a standby mode for conversion into energy. In a standby mode of the fluid operated inflatable device in which both the first piezoelectric pump and the second piezoelectric pump are in a standby mode, vibrations due to movement of a patient in which the fluid operated inflatable device is implanted are harvested by the first piezoelectric pump and the second piezoelectric pump for conversion into energy.

In some embodiments, the fluidic architecture comprises: a first unidirectional pump and a first passive valve positioned in the first fluid passageway to selectively create and control fluid flow in a first direction from the expandable member to the reservoir; a second unidirectional pump and a second passive valve positioned in the second fluid passageway to selectively create and control fluid flow in a second direction from the reservoir to the expandable member; a first sensing device positioned to sense fluid pressure at the reservoir; a second sensing device positioned to sense fluid pressure at the expandable member; and an active valve positioned in accordance with the expandable member. In a first mode, the active valve is configured to close by the electronic control system in response to detecting a pressure spike at the inflatable member to prevent deflation of the inflatable member; and in a second mode, the active valve is configured to be opened by the electronic control system in response to detecting a loss of power to the electronic fluid control system to allow deflation of the inflatable member.

In some embodiments, the fluidic architecture comprises: a first unidirectional pump positioned in the first fluid passageway and configured to create a flow of fluid in a first direction from the expandable member to the reservoir; a second unidirectional pump positioned in the second fluid passageway and configured to create a flow of fluid in a second direction from the reservoir to the expandable member; a first passive valve positioned in the first fluid passageway between the first unidirectional pump and the reservoir to restrict fluid flow in the first direction in the first fluid passageway and prevent backflow of fluid in the first fluid passageway while the second unidirectional pump is in the operational mode and the first unidirectional pump is in the standby mode; a second passive valve positioned in the second fluid path between the second unidirectional pump and the reservoir to restrict fluid flow in the second direction in the second fluid path and prevent backflow of fluid in the second fluid path while the first unidirectional pump is in the operational mode and the second unidirectional pump is in the standby mode; a first sensing device positioned to sense fluid pressure at the reservoir; and a second sensing device positioned to sense fluid pressure at the expandable member.

In some embodiments, the fluidic architecture comprises: a unidirectional pump positioned in the fluid pathway; a first active valve positioned in the fluid path between the pump and the reservoir and configured to be selectively activated by the electronic control system; a second active valve positioned in the fluid passageway between the pump and the expandable member and configured to be selectively activated by the electronic control system; a third active valve positioned in the fluid path between the pump and the reservoir and configured to be selectively activated by the electronic control system; and a fourth active valve positioned in the fluid path between the pump and the expandable member and configured to be selectively activated by the electronic control system. In the expansion 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 so that fluid is pumped from the reservoir to the expandable member; and in the deflate mode, the third and fourth active valves are opened by the electronic control system and the first and second active valves are closed by the electronic control system so that fluid is pumped from the expandable member to the reservoir.

In some embodiments, the fluidic architecture comprises: a first combined pump and valve device positioned in the first fluid passageway to selectively create and control fluid flow in a first direction from the expandable member to the reservoir; a first sensing device positioned to sense fluid pressure at the reservoir; a second combined pump and valve device positioned in the second fluid passageway to selectively create and control fluid flow in a second direction from the reservoir to the inflatable member; and a second sensing device positioned to sense fluid pressure at the expandable member.

In some embodiments, the fluidic architecture comprises: a first piezoelectric pump and valve device positioned in the first fluid passageway, wherein the first piezoelectric pump and valve device are configured to selectively generate and control fluid flow in a first direction from the expandable member to the reservoir and to sense fluid pressure at the reservoir; and a second piezoelectric pump and valve device positioned in the second fluid path, wherein the second piezoelectric pump and valve device are configured to selectively generate and control fluid flow in a second direction from the reservoir to the expandable member and to sense fluid pressure at the expandable member. In some embodiments, the fluidic architecture comprises: a pump; a first three-way valve positioned between the pump and the reservoir, the first three-way valve having a first port thereof open to maintain fluid communication with the pump; and a second three-way valve positioned between the pump and the expandable member, the second three-way valve having its first port open to maintain fluid communication with the pump. In the compact 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 of the first three-way valve to the second port thereof; and 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 of the second three-way valve to the second port thereof. In the expansion 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 of the first three-way valve to the third port thereof; 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 of the second three-way valve to the third port thereof.

Drawings

Fig. 1 is a block diagram of an implantable fluid-operated inflatable device according to an aspect.

Fig. 2A and 2B illustrate an example implantable fluid operated inflatable device according to an aspect.

Fig. 3 is a schematic illustration of a fluidic architecture of an implantable fluid operated expandable device according to an aspect.

FIG. 4 is a schematic diagram of an example electronic fluid control system for an implantable fluid-operated inflatable device.

FIG. 5 is a schematic diagram of a first example fluidic architecture of the example fluid control system shown in FIG. 4.

FIG. 6 is a schematic diagram of a second example fluidic architecture of the example fluid control system shown in FIG. 4.

FIG. 7 is a schematic diagram of a third example fluidic architecture of the example fluid control system shown in FIG. 4.

FIG. 8 is a schematic diagram of a fourth example fluidic architecture of the example fluid control system shown in FIG. 4.

FIG. 9 is a schematic diagram of a fifth example fluidic architecture of the example fluid control system shown in FIG. 4.

FIG. 10 is a schematic diagram of a sixth example fluidic architecture of the example fluid control system shown in FIG. 4.

FIG. 11 is a schematic illustration of a seventh example fluid flow architecture of the example fluid control system shown in FIG. 4.

Fig. 12A-12C are schematic illustrations of an example implantable fluid operated inflatable device according to an aspect.

Fig. 13A and 13B are schematic illustrations of an example implantable fluid operated inflatable device according to an aspect.

Detailed Description

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

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

In general, embodiments are directed to body implants. The term patient or user may hereinafter be used to benefit from the medical devices or methods disclosed in the present disclosure. For example, the patient may be a person whose body is implanted with the medical device of the present disclosure or a method for operating the medical device is disclosed.

Fig. 1 is a block diagram of an example implantable fluid-operated inflatable device 100. The example apparatus 100 illustrated in fig. 1 includes a fluid reservoir 102, an expandable member 104, and a fluid control system 106, the fluid control system 106 including fluidic components such as one or more pumps, one or more valves, and the like, configured to transfer fluid between the fluid reservoir 102 and the expandable member 104. The fluid control system 106 may include one or more sensing devices that sense conditions within the fluidic system of the device 100 such as, for example, fluid pressure, fluid flow rate, etc. In some implementations, the example apparatus 100 includes an electronic control system 108. The electronic control system 108 may provide for monitoring and/or controlling the operation of the various fluidic components of the fluid control system 106 and/or communication with one or more sensing devices within the implantable fluid operated 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, a memory, a communication module, a power storage device or battery, a sensing device (such as, for example, an accelerometer), and other such components configured to provide for operation and control of the implantable fluid-operated inflatable device 100. For example, the communication module may provide for communication with one or more external devices, such as, for example, the external controller 120. The external controller 120 may be configured to receive user input through, for example, a user interface, and communicate the user input to the electronic control system 108 for processing, operation, and control of the device 100, for example, through a communication module. The electronic control system 108 may communicate the operation information to the external controller 120 through a communication module. This may allow the operational state of the inflatable device 100 to be provided to a user, such as through a user interface, and diagnostic information to be provided to a physician, etc. In some examples, the external controller 120 includes a power transfer module to provide for charging components of the internal electronic control system 108. In some examples, the power transfer for recharging the internal electronic control system 108 is provided in an external device separate from the external controller 120. In some implementations, the external controller 120 may include sensing devices such as pressure sensors, accelerometers, and other such sensing devices. An external pressure sensor in the external controller 120 may provide, for example, a local atmospheric pressure or operating pressure to the internal electronic control system 108 to allow the inflatable device 100 to compensate for pressure changes. The accelerometer in the external controller 120 may provide the detected patient motion to the internal electronic control system 108 for control of the inflatable device 100. The fluid reservoir 102, the expandable member 104, and the fluid control system 106 may be implanted internally within a patient. In some embodiments, the electronic control system 108 is coupled to or incorporated into a housing of the fluid control system 106. In some embodiments, at least a portion of the electronic control system 108 is physically separate from the fluid control system 106. In some implementations, some of the modules of the electronic control system 108 are coupled to or incorporated into the fluid control system 106, and some of the modules of the electronic control system 108 are separate from the fluid control system 106. For example, in some embodiments, some of the modules of the electronic control system 108 are included in an external device (such as external controller 120) that communicates with other modules of the electronic control system 108 included within the implantable device 100. In some embodiments, the operation of the implantable fluid-operated inflatable device 100 may be manually controlled.

In some examples, electronic monitoring and control of the fluid operated inflatable device 100 may provide for improved patient control of the device, improved patient comfort and improved patient safety. In some examples, electronic monitoring and control of the fluid operated device 100 may provide opportunities for customizing the operation of the device 100 by a physician without further surgical intervention. Defining a fluidic architecture for the flow and control of fluid through the fluid-operated inflatable device 100 (including the placement of fluidic components such as pumps, valves, sensing devices, etc.) may allow the device 100 to effectively respond to user input and quickly and effectively accommodate changes in conditions both inside the inflatable device 100 (changes in pressure, flow rate, etc.) and outside the inflatable device 100 (pressure surges due to physical activity, shock, etc., sustained pressure changes due to changes in atmospheric conditions, and other such changes in external conditions).

The example implantable fluid-operated inflatable device 100 may represent a wide variety of different types of implantable fluid-operated devices. For example, the device 100 shown in fig. 1 may represent an artificial urinary sphincter 100A as shown in fig. 2A, an inflatable penile prosthesis 100B as shown in fig. 2B, and other such implantable inflatable devices that rely on control of fluid flow to the device components to effect inflation, pressurization, deflation, depressurization, deactivation, and the like.

The example artificial urinary sphincter shown in fig. 2A includes: a fluid control system 106A, the fluid control system 106A including fluidic components such as pumps, valves, sensing devices, and the like, positioned in the fluid pathway; and an electronic control system 108A, the electronic control system 108A configured to provide for transfer of fluid between the reservoir 102A and the inflatable cuff (cuff) 104A via the fluidic component. The fluidic components of fluid control system 106A and the electronic components of electronic control system 108A may be housed in housing 110A. The first conduit 103A connects the first fluid port 107A of the fluid control system 106A/electronic control system 108A housed in the housing 110A with the reservoir 102A. A second conduit 105A connects a second fluid port 109A of the fluid control system 106A/electronic control system 108A, which is housed in the housing 110A, with the inflatable cuff 104A.

The example penile prosthesis 100B shown in fig. 2B includes: a fluid control system 106B, the fluid control system 106B including fluidic components such as pumps, valves, sensing devices, and the like, positioned in the fluid pathway; and an electronic control system 108B, the electronic control system 108B configured to provide for transfer of fluid between the reservoir 102B and the inflatable cylinder (cylinder) 104B via the fluidic component. Fluidic components of fluid control system 106B and electronic components of electronic control system 108B may be housed in housing 110B. The first conduit 103B connects the first fluid port 107B of the fluid control system 106B/electronic control system 108B housed in the housing 110B with the reservoir 102B. One or more second conduits 105B connect one or more second fluid ports 109B of the fluid control system 106A/electronic control system 108A housed in the housing with the inflatable cylinder 104B.

The principles to be described herein may be applied to these and other types of implantable fluid-operated inflatable devices that rely on pump assemblies including various fluidic components to provide for the delivery of fluids between different fluid-filled implantable components to achieve inflation, deflation, pressurization, depressurization, deactivation, occlusion, and the like for efficient operation. The example apparatus 100A, 100B shown in fig. 2A and 2B includes an electronic control system 108A, 108B to provide for monitoring and control of pressure and/or fluid flow through the respective apparatus 100A, 100B. Some of the principles to be described herein may also be applied to manually controlled implantable fluid operated inflatable devices.

As described above with respect to fig. 1, the fluid control system 106 may include a pump assembly including, for example, one or more pumps and one or more valves positioned within a fluid circuit of the pump assembly to control the delivery of fluid between the fluid reservoir 102 and the expandable member 104. In some examples, the pump(s) and/or valve(s) are electronically controlled. In some examples, the pump(s) and/or valve(s) are manually controlled. In some examples, the pump assembly includes a fluid manifold having a fluidic channel formed therein defining a fluid circuit. In examples where the pump assembly is electronically powered and/or controlled, the manifold may be a closed manifold that may contain and divide the flow of fluid 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 to provide relatively accurate monitoring and control of fluid flow and/or fluid pressure within the fluid circuit and/or the expandable member. A fluid circuit configured in this manner may facilitate proper inflation, deflation, pressurization, depressurization, and deactivation of components of the implantable fluid-operated device to provide for patient safety and device efficacy.

Fig. 3 is a schematic diagram of an example fluidic architecture for an implantable fluid operated inflatable device according to an aspect. The fluidic architecture of the implantable fluid-operated inflatable device may include other orientations of the fluidic channel, valve(s), pressure sensor(s), and other components shown in fig. 3. The fluidic architecture, being able to accommodate back pressure and pressure surges, etc., enhances the performance, efficacy, and efficiency of the fluid-operated device 100.

The example fluidic architecture shown in fig. 3 includes channels that direct the flow of fluid between the reservoir 102 and the expandable member 104. In the example shown in fig. 3, a first valve V1 in the first fluidic channel controls the flow of fluid generated by the first pump P1 from the expandable member 104 to the reservoir 102. A second valve V2 in the second fluidic channel controls the flow of fluid generated by the second pump P2 from the reservoir 102 to the expandable member 104. The first sensing device S1 senses the fluid pressure at the reservoir 102 and the second sensing device S2 senses the fluid pressure at the expandable member 104. The first and second sensing means S1, S2 may provide for monitoring of the fluid flow and/or the fluid pressure in the fluidic channel. In the arrangement shown in fig. 3, one of the first pump P1 or the second pump P2 is active, while the other of the first pump P1 or the second pump P2 is in a standby mode, so that the first and second pumps P1, P2 typically do not operate simultaneously. The operation of the first and second pumps P1, P2 and the first and second valves V1, V2 (between the open and closed states) may be controlled by the control system 108 as described above based on conditions (e.g., fluid pressure and/or fluid flow rate) in the first and second fluid passages in the region proximate the reservoir 102 and the expandable member 104 as sensed by the first and second sensing devices S1, S2.

For example, operation of the first pump P1 with the first valve V1 open (and with the second pump P2 in standby mode and the second valve V2 closed) may provide for deflation of the inflatable member 104. The first pump P1 continues to operate until the pressure sensed by the second sensing device S2 (which is positioned in accordance with the expandable member 104) indicates that the desired deflation state of the expandable member 104 has been achieved (e.g., based on the fluid pressure sensed by the second sensing device S2). To maintain the contracted state, both the first and second pumps P1, P2 may be placed in a standby mode, and both the first and second valves V1, V2 may be closed. Operation of the second pump P2 with the second valve V2 open (and with the first pump P1 in standby mode and the first valve V1 closed) may provide for expansion of the expandable member 104. The second pump P2 continues to operate until the pressure sensed by the first sensing device S1 indicates that the desired inflation state of the inflatable member 104 has been achieved (e.g., based on the fluid pressure sensed by the first sensing device S2). To maintain the expanded state, both the first and second pumps P1, P2 may be placed in a standby mode, and both the first and second valves V1, V2 may be closed. The valves V1, V2 may provide selective sealing for the respective fluidic channel(s) in order to maintain the set state of the fluid operated device. Interaction with the valves V1, V2 (and corresponding changes in fluid flow through the fluidic architecture of the device) can change the set-up state of the fluid operated device. The valves V1, V2, which maintain the set state of the device until the patient requests a change in the set state of the device and initiates the requested change in the set state of the device, provide enhanced patient safety and device efficacy.

In some examples, one or more valves included in the fluidic architecture are normally open valves. The normally open valve defaults to an open state and closes (and remains closed) in response to the application of power. The use of a normally open valve in the example arrangement shown in fig. 3 may provide a fail-safe in the event of, for example, a power failure or other system failure (which would result in the pumps P1, P2 and/or valves V1, V2 being out of control). For example, in a state where the expandable member 104 expands, the valves V1, V2 are closed, and the pumps P1, P2 are in a standby state, causing this type of uncontrolled power loss (or other system failure) may cause patient discomfort and/or endanger patient safety. The use of normally open valves in the fluidic architecture allows the valves V1, V2 to open in the event of a power loss, pressure to be released from the expandable member 104, and allows the fluid in the system to equilibrate.

In some examples, one or more valves included in the fluidic architecture may be normally closed valves that default to a closed state and open (and remain open) in response to the application of power. Depending on the position of the normally closed valve in the fluidic architecture, the normally closed valve may not provide the fail-safe measures described above. However, the use of one or more normally closed valves in the fluidic architecture may reduce the power consumption of the fluid operated inflatable device 100. Many valves included in the fluidic architecture remain in the closed state for a period of time that substantially exceeds the time that they are in the open state (e.g., to maintain the current state of the fluid-operated inflatable device 100). Because normally closed valves default to a closed state and are independent of the application of power to remain in the closed state, the use of one or more normally closed valves in a fluidic architecture may reduce power consumption (when compared to the use of normally open valves). This may increase the life of the fluid-operated inflatable device 100, reduce the physician intervention (e.g., battery replacement) required for continued operation, and/or reduce recharging requirements and/or increase the interval between recharging.

The power consumption may be reduced by passive movement of fluid through the fluidic channel of the fluid operated inflatable device 100 to reduce the amount of pumping required to achieve the desired deflation level of the inflatable member 104. For example, in the expanded state, the pressure at the expandable member 104 is greater than the pressure at the reservoir 102. In the example arrangement shown in fig. 3, to achieve a desired deflation level of the inflatable member 104, the first valve V1 may be opened (without activating the first pump P1, and with the second valve V2 closed and the second pump P2 in standby mode) to allow fluid to naturally flow out of the inflatable member 104. Based on the fluid pressure sensed by the first and/or second sensing means S1, S2, the first pump P1 may be activated to release any residual pressure not released by the passive flow of fluid out of the expandable member 104 in this manner.

In some examples, a pressure sensing device (such as sensing devices S1, S2 shown in the example fluidic architecture shown in fig. 3) may support various different ways of regulating, measuring, and controlling pressure in the fluidic architecture of the fluid operated inflatable device 100, and may be positioned so as to provide for monitoring of fluid pressure at the reservoir 102 and the inflatable member 104. For example, the sensing devices S1, S2 (and/or other pressure sensing devices) may be positioned to detect fluid pressure surges or spikes at various locations within the fluid-operated inflatable device 100, and control the pumps P1, P2 and valves V1, V2 accordingly to maintain the current state of the fluid-operated inflatable device 100 and/or to provide comfort and safety for the patient.

For example, the fluid reservoir 102A of the example artificial urinary sphincter 100A described above with respect to fig. 2A is placed within the patient's abdominal cavity. A pressure sensing device (such as the first sensing device S1) positioned at the fluid reservoir 102A may thereby provide an indication of abdominal pressure. If a pressure spike or surge (e.g., due to physical activity, impact, fall, etc.) is detected by the first sensing device S1, the system may respond by, for example, increasing the pressure at the inflatable cuff 104A, and the patient may remain self-contained through the pressure spike. In examples including a first sensing device S1 at the reservoir 102A and a second sensing device S2 at the inflatable cuff 104A, the pressure measurements taken by each of the sensors S1, S2 may be used to determine, for example, how much pressure is needed at the inflatable cuff 104A to counteract the pressure spike at the reservoir 102A.

As described above, in the expanded state, the pressure at the expandable member 104 is greater than the pressure at the reservoir 102. The pressure differential between the expandable member 104 and the reservoir 102 may be used for passive deflation of the expandable member 104. When the fluid in the inflatable device 100 reaches equilibrium, measurements from sensing devices S1, S2 positioned at the reservoir 102 and the inflatable member 104 as shown in the example fluidic architecture of fig. 3 may be used to determine when to engage the first pump P1 to maximize energy savings while also managing the time for the inflatable member 104 to transition from the inflated state to the desired deflated level. In some examples, the positioning of the first and second sensing devices S1, S2 as shown may provide detection of blockages, slow leaks, etc. within the fluidic architecture, and may allow the system to operate the pumps P1, P2 and valves V1, V2 to compensate for the detected faults.

In the example arrangement shown in fig. 3, to achieve a desired deflation level of the inflatable member 104, the first valve V1 may be opened (without activating the first pump P1, and with the second valve V2 closed and the second pump P2 in standby mode) to allow fluid to naturally flow out of the inflatable member 104. Based on the fluid pressure sensed by the first and/or second sensing means S1, S2, the first pump P1 may be activated to release any residual pressure not released by the passive flow of fluid out of the expandable member 104 in this manner.

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

FIG. 5 illustrates an example electronic fluid control system 400 including the fluid control system 106 having a first example fluid-dynamic architecture 410. The first example fluidic architecture 410 includes: a first pump P1 and a first valve V1 that control the flow of fluid in a first direction from the expandable member 104 to the reservoir 102; and a second pump P2 and a second valve V2 that control the flow of fluid in a second direction from the reservoir 102 to the expandable member 104. In the first example fluidic architecture 410 shown 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 the first fluidic channel and allows flow only 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 the second fluid passage and allows flow only in the second direction. The first sensing device S1 is positioned to sense the fluid pressure at the reservoir 102 and the second sensing device S2 is positioned to sense the fluid pressure at the expandable member 104. The first and second passive check valves V1, V2, which are arranged relative to the first and second pumps P1, P2 as shown, prevent backflow of fluid through the pumps P1, P2. The first example fluidic architecture 410 includes an active valve AV positioned in accordance with the expandable member 104. The active valve AV, positioned as shown, may prevent the escape of fluid from the expandable member 104 through the first pump P1 and may inadvertently deflate the expandable member 104 in response to a sudden surge in pressure at the expandable member 104 due to, for example, shock, physical exertion, and fall.

FIG. 6 illustrates an example electronic fluid control system 400 including the fluid control system 106 having a second example fluid-dynamic architecture 420. The second example fluidic architecture 420 includes: a first pump P1 and a first valve V1 that control the flow of fluid in a first direction from the expandable member 104 to the reservoir 102; and a second pump P2 and a second valve V2 that control the flow of fluid in a second direction from the reservoir 102 to the expandable member 104. In the second example fluidic architecture 420 shown 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 the first fluidic channel and allows flow only 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 the second fluid passage and allows flow only in the second direction. The first sensing device S1 is positioned to sense the fluid pressure at the reservoir 102 and the second sensing device S2 is positioned to sense the fluid pressure at the expandable member 104. The first passive check valve V1, which is disposed relative to the first pump P1 as shown, prevents backflow of fluid through the first pump P1 and prevents accidental flow of fluid from the expandable member 104 to the reservoir 102. The second passive check valve V2, arranged as shown, prevents backflow of fluid through the second pump P2.

FIG. 7 illustrates an example electronic fluid control system 400 including the fluid control system 106 having a third example fluid-dynamic architecture 430. The third example fluidic architecture 430 includes: a first pump P1 and a first valve V1 that control the flow of fluid in a first direction from the expandable member 104 to the reservoir 102; and a second pump P2 and a second valve V2 that control the flow of fluid in a second direction from the reservoir 102 to the expandable member 104. In the third example fluidic 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 the first fluidic channel and allows flow only 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 the second fluid passage and allows flow only in the second direction. The first sensing device S1 is positioned to sense the fluid pressure at the reservoir 102 and the second sensing device S2 is positioned to sense the fluid pressure at the expandable member 104. The first and second passive check valves V1, V2, which are disposed relative to the first and second pumps P1, P2 as shown, prevent backflow of fluid through the pumps P1, P2. The third example fluidic architecture 430 includes an active valve AV that is positioned to act as a failsafe in the event of a power loss. In the arrangement of components shown in the third example fluidic architecture, the active valve AV may be a normally open valve. In the event of a power loss of the electronic fluid control system 400, the active valve AV will open and allow the inflatable member 104 to decompress, thereby providing comfort and safety for the patient.

FIG. 8 illustrates an example electronic fluid control system 400 including a fluid control system 106 having a fourth example fluid-dynamic architecture 440. The fourth example fluidic 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 examples 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 a voltage. By actively opening the first and second active valves AV1 and AV2 and actively closing the third and fourth active valves AV3 and AV4, fluid may be pumped from the reservoir 102 to the expandable member 104 to expand the expandable member 104. By actively closing the first and second active valves AV1 and AV2 and actively opening the third and fourth active valves AV3 and AV4, fluid may be pumped from the expandable member 104 to the reservoir 102 to deflate the expandable member 104.

FIG. 9 illustrates an example electronic fluid control system 400 including the fluid control system 106 having a fifth example fluid-dynamic architecture 450. As with the example fourth fluidic architecture 440, the fifth example fluidic architecture 440 employs one pump P1. The fifth example fluidic architecture 450 shown in fig. 9 replaces the four active valves AV1, AV2, AV3, AV4 shown in fig. 8 with two three-way latching valves LV1, LV 2. In the fifth example fluidic architecture, port 1 on the first latching valve LV1 and port 1 on the second latching valve LV2 are always open. Energizing the first blocking valve LV1 allows one of the other ports 2 or 3 of the first blocking valve LV1 to communicate with the opened port 1. Similarly, energizing the second blocking valve LV2 allows one of the other ports 2 or 3 of the second blocking valve LV2 to communicate with the opened port 1. By selecting port 2 on both the first blocking valve LV1 and the second blocking valve LV2, fluid can flow between port 1 and port 2 to allow the pump P1 to transfer fluid from the expandable member 104 to the reservoir 102 when port 3 of each of the first blocking valve LV1 and the second blocking valve LV2 is closed. Similarly, by selecting port 3 of each latching valve LV1, LV2 (and thus closing port 2), fluid can flow between port 1 and port 3 to allow the pump to transfer fluid from reservoir 102 to inflatable member 104.

FIG. 10 illustrates an example electronic fluid control system 400 including a fluid control system 106 having a sixth example fluid-dynamic architecture 460. The sixth example fluidic architecture includes a first pump P1 that produces fluid flow in a first direction from the expandable member 104 to the reservoir 102; and a second pump P2 that produces fluid flow in a second direction from the reservoir 102 to the expandable member 104. In a sixth example fluidic architecture 460 shown in fig. 10, the first pump P1 and the second pump P2 are combined pump and valve devices. For example, when the first pump P1 is in the standby mode, the first pump P1 prevents the flow of fluid through the first fluid passage, and thus does not operate/pump. Similarly, when the second pump P2 is in the standby mode, the second pump P2 prevents the flow of fluid through the second fluid passage, and thus does not operate/pump.

Fig. 11 illustrates an example electronic fluid control system 400 including a fluid control system 106 having a seventh example fluid schematic 470. A seventh example fluidic architecture includes: a first pump P1 that generates a fluid flow in a first direction from the expandable member 104 to the reservoir 102; and a second pump P2 that produces fluid flow in a second direction from the reservoir 102 to the expandable member 104. In the seventh example fluidic architecture 470 shown in fig. 11, the first pump P1 and the second pump P2 are combined pump and valve devices, as in the sixth example fluidic architecture 460 shown in fig. 10, and thus flow through the fluid channel between the reservoir 102 and the expandable member 104 (in addition to creating fluid flow through the fluid channel) may also be selectively restricted. However, in the seventh example fluidic architecture 470 shown in fig. 11, the first and second pumps P1, P2 may be piezoelectric pumps. The piezoelectric element of the piezoelectric pump can sense pressure changes. Thus, in the seventh example fluidic architecture 470, the first and second pumps P1, P2 (in the form of piezoelectric pumps) may also be used as pressure sensing devices, and thus the sensing devices S1, S2 shown in the previous fluidic architecture may be eliminated. This may simplify the fluidic architecture of the fluid control system 106 and may reduce the overall size of the electronic fluid control system 400.

Thus, in some examples, one or more valves included in the fluidic architecture of the fluid control system 106 may be piezoelectric valves. Piezoelectric materials produce electrical energy when mechanically deformed by strain. Instead, the piezoelectric material deforms in response to an applied electric field. That is, piezoelectric materials may convert charge to motion, and vice versa. These properties allow the mechanical valve to be electronically controlled by applying a voltage to the valve. During operation, the fluid-operated inflatable device 100 may be subjected or subjected to external stimuli such as vibrations. The vibration source may be, for example, vibrations due to operation of one pump, vibrations due to movement of fluid through the fluid-operated inflatable device 100, movement of a user, and/or other physical activity, as well as other such sources internal and external to the device 100. These external stimuli can be converted into energy in view of the ability of the piezoelectric material of the piezoelectric valve to generate an electrical potential in response to forced motion. In some examples, the external stimulus (e.g., in the form of vibration) may be converted into energy by the pump being in a standby mode when experiencing vibration.

As described above with respect to the example fluidic 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) produces fluid flow in a first direction (from the expandable member 104 to the reservoir 102) for deflation of the expandable member 104. Operation of the second pump P2 (with the second valve V2 open, the first pump P1 in standby mode, and the first valve closed) produces fluid flow in the second direction (from the reservoir 102 to the expandable member 104) for expansion of the expandable member 104. To maintain the set state (i.e., the expanded state or the contracted state) of the fluid-operated expandable device 100, the first and second pumps P1, P2 are in a standby mode, and the first and second valves V1, V2 are closed.

In the example fluidic architecture shown in fig. 3, at least one of the pumps P1, P2 will be in standby mode at any given time and thus can be used to collect and convert the stimulus as described above into an electrical displacement. In this example, one of the pumps P1 or P2 (the pump in operation) acts as an energy actuator or generator, while the other of the pumps P1 or P2 (the pump in standby mode) acts as an energy harvester or collector. If pumps P1, P2 are piezoelectric pumps and valves V1, V2 are piezoelectric valves, the example fluidic architecture shown in FIG. 3 may include up to four piezoelectric elements. However, in this example, pumps P1 and P2 act as actuators and harvesters so that the latching and/or sealing capabilities of valves V1, V2 are not compromised during operation of fluid operated inflatable device 100.

As described above, during operation of the device 100 in the compact mode, vibrations due to operation of the first pump P1 may 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 case, the piezoelectric element of the second pump P2 (in standby mode) will be ready to harvest the energy generated by the vibrations that are experienced as movements at the piezoelectric element of the second pump P2. In some cases, hydraulic pressure may also act on the second pump P2, thereby contributing to the amplitude of the motion experienced by the piezoelectric element of the second pump P2 and causing additional energy to be generated by the amplified motion. During operation in the expansion mode, wherein the second pump P2 is in operation and the first pump P1 is in the standby mode, the second pump P2 will operate to transfer fluid from the reservoir 102 to the expandable member 104, and the first pump P1 will harvest energy due to operation of the second pump P2. In some cases, the body motion of the user may be translated into motion of the piezoelectric elements of pumps P1, P2. Such movement may also be harvested by the first pump P1 and/or the second pump P2 when in standby mode.

Harvesting and storing energy in this manner converts energy that would otherwise be dissipated and unused through the device 100. Thus, harvesting and storing energy in this manner may increase the life of power storage device 130 without recharging or replacing the power source, and may increase the operating time of fluid-operated device 100. This may also allow for the use of smaller power storage devices 130, thereby reducing the overall size of electronic fluid control system 400.

As described above, in some examples, the fluid-operated inflatable device 100 (e.g., in the form of the artificial urinary sphincter 100A or the inflatable penile prosthesis 100B described above) may be electronically controlled by the electronic control system 108. The electronic control system 108 may be in communication with an external controller 120, which external controller 120 may be operated, for example, by a user. The external controller 120 may receive user input and communicate the user input to the electronic control system 108 for control of the fluid-operated inflatable device 100. The electronic control system 108 may communicate information to an external controller 120 such as, for example, device operating status, system alarms, operating conditions, etc., for use by a user. The quick, reliable communication between the external controller 120 and the electronic control system 108 facilitates proper function and operation of the device 100 under different conditions to provide comfort and ease of use to the patient during the lifetime of the fluid-operated inflatable device 100. The quick, reliable communication between the external controller 120 and the electronic control system 108 may improve patient safety and allow the fluid-operated inflatable device 100 to adapt to changing conditions and employ fail-safe measures with or without patient and/or physician intervention.

In some examples, the external controller 120 includes a remote control (fob) that is specifically tailored for controlling, monitoring, and interacting with the fluid-operated 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-operated 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, tablet computing device, or the like.

In some cases, communication between the external controller 120 and the electronic control system 108 of the fluid-operated inflatable device 100 may be initiated by the patient, and changes in the operation and control of the fluid-operated inflatable device 100 may be initiated manually. In some cases, electronic control of the fluid-operated inflatable device 100 is automated under the control of the electronic control system 108.

In some examples, manual control of the fluid operated inflatable device 100 may allow the patient to manually configure settings. For example, in some cases, the patient may find that more or less pressure at the expandable member 104 may improve comfort and/or operability and/or safety. For example, in the case of the example artificial urinary sphincter 100A, the patient can configure the pressure setting at the inflatable cuff 104A using the external controller 120 based on observed device performance and physical activity, etc. For example, if the patient is lightly incontinent at the current setting, the patient may use the external controller 120 to increase the occlusion pressure setting for the inflatable cuff 104A. In some examples, due to a particular physical activity (e.g., temporarily, during the physical activity, perhaps affecting continence ability), the patient may want to adjust the pressure setting at the inflatable cuff 104A, and the external controller 120 may be used to set the adjusted occlusion pressure for the inflatable cuff 104A for a set period of time, allowing the device 100 to revert to the previously stored setting after the set period of time has elapsed.

In some examples, manual control of the fluid-operated inflatable device 100 may be activated by a sub-audible signal (sub-audible signaling) from the patient. In some examples, the sub-audible signal may be detected by the external controller 120 and transmitted to the electronic control system 108 for control of the fluid-operated inflatable device 100. In some examples, the audible signal may be detected by the electronic control system 108. In some examples, manual control of the fluid-operated inflatable device 100 may be activated in response to pressure spikes detected as a result of a tap (e.g., an in-sequence tap performed by a patient and detected by the fluid-operated inflatable device 100). In the event that the external controller 120 is not available to the patient for some reason (misplaced, uncharged, inoperable, etc.), the fluid operated inflatable device 100 may respond to a sub-audible signal from the patient, for example, to adjust the pressure at the inflatable member 104. This may improve patient safety and comfort.

In some examples, a configurable number of taps (e.g., on the torso of the patient, at or near the implanted location of the fluid-operated inflatable device, or other locations) may define a unique sequence or pattern that triggers manual control of the fluid-operated inflatable device 100. This unique sequence or pattern may prevent the fluid-operated inflatable device 100 from being accidentally activated due to an unintended tap detected by the device 100. In some examples, the piezoelectric element of the pump or valve may act as a microphone, which may detect a set audible or sub-audible signal. In some examples, the detected signal may, for example, command a pump or valve to open, with a corresponding displacement producing a measurable current.

In some examples, one or both of the implantable fluid-operated expandable device 100 and/or the external controller 120 includes a motion detection device, such as, for example, an accelerometer, which may detect a motion event. In some cases, the motion event may cause a change in conditions within the fluid-operated inflatable device 100, which may benefit from adjustment of operating parameters of the device 100 for the motion event. For example, in the artificial urinary sphincter 100A described above, movements associated with events such as coughing, sneezing, lifting, exercise/physical activity, etc., can lead to incontinence. Detection of this type of motion event by the accelerometer may trigger execution of an algorithm, such as by the processor of the electronic control system 108, that increases the pressure at the inflatable cuff 104A to provide additional pressure at the urethra during the motion event, thereby preventing incontinence. In some examples, the need for additional pressure at, for example, the expandable member 104 in response to these types of motion events may be detected based on changes in pressure/pressure fluctuations detected by sensing devices included in the fluidic architecture. For example, a detected increase in intra-abdominal pressure (e.g., compression due to coughing or sneezing, bending over, and/or lifting movements, etc.) may be communicated to the reservoir 102, thereby increasing the internal pressure of the device 100 at the reservoir 102. The increased pressure at the reservoir 102 detected by one of the sensing devices may be processed by an algorithm executed by the electronic control system so that operation of pumps and valves within the fluidic system may be adjusted to apply the appropriate pressure at the reservoir 102 and the inflatable member 104 to maintain the current state of the fluid-operated inflatable device 100.

In some examples, manual control of the fluid-operated inflatable device 100 may be implemented through the use of a backup activation device (e.g., a magnet) in the event that the external controller 120 is not available to the patient for some reason (misplaced, uncharged, inoperable, etc.). For example, in the event that an external controller is unavailable and the patient needs to release pressure on the inflatable cuff 104A of the artificial urinary sphincter 100A, application of a backup activation device/magnet at a location corresponding to the implantable device 100A may activate a read switch, controlling the pump and valve within the fluidic architecture to operate to release pressure on the inflatable cuff 104A, allowing the inflatable cuff 104A to open and release the urethra.

In some examples, manual control of the fluid-operated inflatable device 100, particularly when the external controller 120 is not available, may include manual pressure applied to the device 100 from the outside. In some examples, this may include an externally applied pressure that acts as a first sequence of wake-up signals, followed by an externally applied pressure that acts as a second sequence of activation signals. For example, the externally applied pressure may be in the form of a pulling penis, which creates pressure fluctuations in the fluid path of the artificial urinary sphincter 100A, particularly in the vicinity of the inflatable cuff 104A. In this example, a first sequence of pulls may wake up the artificial urinary sphincter 100A and a second sequence of pulls may signal release of pressure at the inflatable cuff 104A, causing the cuff to open to release the urethra and the patient to urinate. In some examples, pulling the form of pressure in this manner may also produce a sub-audible signal that may be detected by the piezoelectric element acting as a pump and valve for the microphone, as described above.

As described above, in some cases, the electronic control of the fluid-operated inflatable device is automated under the control of the electronic control system 108. This may allow for substantially continuous system monitoring, diagnosis, and adjustment, and for outputting an alarm in response to detecting a condition requiring patient and/or physician intervention.

In some examples, the electronic control system 108 may monitor the operation of the fluid-operated inflatable device 100 to detect conditions that may indicate leaks, blockages, etc., that may jeopardize the operation of the device 100 and/or cause a malfunction of the device 100. For example, the electronic control system 108 may monitor the amount of time to reach a particular pressure at a particular location within the fluidic architecture. A change in pumping time, for example, exceeding a set threshold or set range, and/or failing to reach a particular pressure or a particular pressure range, may be indicative of a leak or blockage within the fluid passageway of the fluid operated expandable device 100. In some examples, the electronic control system 108 generates an alarm, for example, for outputting an alarm via the external controller 120, alerting the patient and/or physician to a possible condition that may jeopardize the operation of the device 100 and/or may result in a malfunction of the device 100. In some examples, the electronic control system 108 may control operation of the pump and valves such that fluid is sealed within portions of the device 100 that are not experiencing leaks.

In some examples, automatic control of the fluid-operated inflatable device 100 includes collecting and storing data for physician diagnosis and adjustment of patient care protocols. In the case of the artificial urinary sphincter 100A, diagnosis typically relies on the bladder diary being manually filled 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 has to urinate in one day, the start-to-end time of each urination event, and other such data. In some examples, the elapsed time for each urination event may be determined based on the amount of time the inflatable cuff 104A is opened and/or the amount of time the inflatable cuff 104A is closed. In some examples, the acoustic properties of the piezoelectric elements of the pump and/or valve may 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 the physician for subsequent diagnosis and treatment.

In some examples, the automatic control of the fluid-operated expandable device 100 includes automatic control of the pressure at the expandable member 104 and/or the reservoir 102 in response to a particular condition. For example, the electronic control system 108 may detect that there is no communication from the external controller 120 to the implantable fluid-operated inflatable device 100 for a set period of time (indicating that the external controller 120 is not available or operational for some reason), and/or that the inflatable member 104 has been in an inflated state for more than a set period of time, etc. In response to detecting this type of condition, the electronic control system 108 may release the pressure setting within the implantable fluid-operated expandable device 100, for example, to release the pressure at the expandable member 104 as a failsafe measure.

In some examples, automatic control of the fluid-operated inflatable device 100 may provide for detection of infection. A sensing device, such as one or more thermocouples in device 100, may record a temperature indicative of the body temperature inside the patient's body. These temperatures may be stored, for example, in a memory of the electronic control system 108. The sensed temperature and fluctuations and/or increases in the sensed temperature may provide an early indication of infection. In some examples, an early prediction of such infection may trigger an alarm to be output to the user for treatment by the physician through the external controller 120.

In some examples, automatic control of the fluid-operated inflatable device 100 may provide for correction of internal device pressure based on atmospheric pressure or air pressure detected by an external device, such as the external controller 120, and communicated to the electronic control system 108. In some examples, the identification of the atmospheric pressure (and the change in atmospheric pressure) is substantially real-time, allowing the electronic control system 108 to automatically control the operation of the pumps and valves to adjust the internal pressure of the device 100 based on the detected atmospheric pressure. The ability of the automatic adjustment device to operate to account for atmospheric pressure changes ensures that the implantable fluid-operated inflatable device 100 maintains a correct internal pressure even in the event of atmospheric conditions changes.

The example implantable fluid-operated inflatable devices 100 described above (e.g., in the form of an artificial urinary sphincter 100A and/or an implantable penile prosthesis 100B) include: the fluid reservoir 102 of the expandable member 104 is connected by the electronic fluid control system 400 through fluid conduits 103, 105 to provide for transfer of fluid between the reservoir 102 and the expandable member 104. Fig. 12A-1C illustrate an example implantable fluid-operated inflatable device in which a fluid reservoir is coupled to a housing of an electronic fluid control system. Fig. 13A and 13B illustrate an example implantable fluid-operated inflatable device in which a fluid reservoir is housed within a housing of an electronic fluid control system.

Fig. 12A-12C are schematic illustrations of an example implantable fluid operated inflatable device 600. In particular, fig. 12A is a schematic view of a first example implantable fluid-operated inflatable device 600A, fig. 12B is a schematic view of a second example implantable fluid-operated inflatable device 600B, and fig. 12C is a schematic view of a third example implantable fluid-operated inflatable device 600C. Each of the three example fluid-operated inflatable devices 600A, 600B, 600C shown in fig. 12A-12C includes: the expandable member 604 coupled to the electronic fluid control system 640 through the fluid conduit 605, and the fluid reservoir 602 coupled, for example, directly to the housing 610 of the electronic fluid control system 640.

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

The example fluid-operated inflatable device 600A shown in fig. 12A includes an electronic fluid control system 640, the electronic fluid control system 640 including electronic and fluidic components housed in a containment enclosure 610, as described above. The fluid conduit 605 has a first end coupled to the expandable member 604 and a second end extending through a port 620 formed in the housing 610 for connection to a fluid control system housed in the housing 610 to provide for transfer of fluid into and out of the expandable member 704. In the arrangement shown in fig. 12A, the reservoir 602A is coupled to a top portion of the containment housing 610 (in the example orientation shown in fig. 12A) or to a transverse plane of the containment housing 610. In some examples, the reservoir 602A is fixed (e.g., adhered or bonded) to the housing 610. The fluid conduit 603A has a first end connected to the reservoir 602A and a second end extending through a port 630A in the housing 610 for connection to a fluid control system housed in the housing 610 to provide for transfer of fluid into and out of the reservoir 602A. Such an example arrangement may present a smaller mating surface area between the hermetic enclosure 610 and the reservoir 602A, and may expose the reservoir 602A to less pressure due to patient movement (e.g., as compared to the example arrangement shown in fig. 12B). In some examples, a lattice (not shown in fig. 12A) may be placed around the exterior of the reservoir 602A to prevent external pressure from being applied to the reservoir 602A.

The example fluid operated inflatable device 600B shown in fig. 12B includes an electronic fluid control system 640, the electronic fluid control system 640 including an inflatable member 604 connected to a fluid control system housed in a containment enclosure 610 via a fluid conduit 605 as described above. The example fluid-operated inflatable device 600B includes a reservoir 602B coupled to a side portion of the hermetic enclosure 610 (in the example orientation shown in fig. 12B) or a coronal plane of the enclosure 610. In some examples, the reservoir 602B is fixed (e.g., adhered or bonded) to the housing 610. Conduit 603B has a first end connected to reservoir 602B and a second end extending through port 630B in housing 610 for connection to a fluid control system housed in housing 610 to provide for transfer of fluid into and out of reservoir 602B. In the example arrangement shown in fig. 12B, the reservoir 602B is bonded to the largest surface of the housing 610. The larger surface area of the reservoir 602B may reduce the expansion required of the reservoir 602B (as compared to the example arrangement shown in fig. 12A).

The example fluid-operated expandable device 600C shown in fig. 12C includes an electronic fluid control system 640, the electronic fluid control system 640 including the expandable member 604 coupled to the fluid control system contained in the containment vessel 610 via the fluid conduit 605 as described above. The example fluid-operated inflatable device 600C includes a reservoir 602C having a bellows structure coupled to a top portion of a containment vessel 610 (in the example orientation shown in fig. 12C). In some examples, a portion (e.g., bottom) of the reservoir 602C is secured (e.g., adhered or bonded) to the housing 610, allowing the remainder of the bellows structure forming the reservoir 602C to expand and contract. Conduit 603C has a first end connected to reservoir 602C and a second end extending through port 630C in housing 610 for connection to a fluid control system housed in housing 610 to provide for transfer of fluid into and out of reservoir 602C. The bellows structure of the example reservoir 602C shown in fig. 12C contracts as fluid is discharged from the reservoir 602C and expands as fluid flows into the reservoir 602C. The bellows structure of the example reservoir 602C shown in fig. 12C allows a wider range of materials to be used for the reservoir 602C, including, for example, titanium polymeric materials, which would allow the reservoir 602C to be hermetically sealed to the hermetic enclosure 610. In some examples, a lattice (not shown in fig. 12C) may be placed around the exterior of the reservoir 602C to prevent external pressure from being applied to the reservoir 602C.

The two-piece example fluid operated inflatable devices 600A, 600B, 600C (including the external fluid reservoirs 602A, 602B, 602C attached to the hermetic enclosure 610) allow the reservoirs 602A, 602B, 602C to expand and contract with limited resistance outside the hermetic enclosure 610 while reducing the overall device 600 to two components (i.e., the inflatable member 604 and the enclosure 610 with the reservoir 602 attached thereto). In some cases, such a design may reduce surgical time and complexity. In some cases, this design may allow the containment vessel 610 to be sutured in place within the patient, thereby reducing in-vivo drift during the lifetime of the implantable fluid-operated inflatable device 600.

Fig. 13A and 13B are schematic illustrations of an example implantable fluid operated inflatable device 700. In particular, fig. 13A is a schematic view of a first example implantable fluid-operated inflatable device 700A, and fig. 13B is a schematic view of a second example implantable fluid-operated inflatable device 700B. The example fluid-operated inflatable devices 700A, 700B shown in fig. 13A and 13B each include an inflatable member 704 coupled to an electronic fluid control system 740 by a fluid conduit 705, and a fluid reservoir 702 housed within a sealed enclosure 710 of the electronic fluid control system 740.

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

The example fluid-operated inflatable device 700A shown in fig. 12A includes an electronic fluid control system 740, the electronic fluid control system 740 including electronic components and fluidic components as described above housed in the hermetic enclosure 710. The fluid conduit 705 has a first end coupled to the expandable member 704 and a second end extending through a port 720 formed in the housing 710 for connection to a fluid control system housed in the housing 710 to provide for transfer of fluid into and out of the expandable member 704. In the arrangement shown in fig. 13A, the reservoir 702A is housed within a hermetically sealed enclosure 710. Because the environment within the containment vessel 710 maintains a fixed amount of gas/fluid, a change in volume within the reservoir 702 will cause a change in pressure within the containment vessel 710, thereby limiting the amount by which the reservoir 702 expands and contracts within the containment vessel 710. The use of a bellows structure for the reservoir 702 may alleviate this, particularly if the containment vessel 710 is filled with a relatively easily compressible gas such as, for example, helium or argon.

The example fluid-operated device 700B shown in fig. 12B includes a closed bellows 12 within a closed housing 710. The closed bellows 712 may be filled with a compressible fluid that acts as a sacrificial gas, allowing the closed bellows 712 to expand when the reservoir 702 is contracted and to contract when the reservoir 702 is expanded. That is, the reservoir 702 (having a bellows structure) expands as fluid is introduced into the reservoir 702, and the closed bellows 712 contracts in response to expansion of the reservoir 702. Reservoir 702 contracts as fluid is expelled from reservoir 702, and closed bellows 712 expands in response to the contraction of reservoir 702.

The example two-piece fluid operated inflatable devices 700A, 700B (including the internal fluid reservoir 702 mounted within the hermetic enclosure 610) may reduce the overall size of the implantable fluid operated inflatable device 700. In some cases, such a design may reduce surgical time and complexity. In some cases, this design may allow the containment vessel 710 to be sutured in place within the patient, thereby reducing in-vivo drift during the lifetime of the implantable fluid-operated inflatable device 700.

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

Claims (35)

1. An implantable fluid-operated inflatable device, comprising:

a fluid reservoir;

an inflatable member;

an electronic fluid control system coupled between the fluid reservoir and the expandable member and configured to control fluid between the fluid reservoir and the expandable member, the electronic fluid control system comprising:

a housing;

a fluid control system housed in the housing, the fluid control system comprising a fluidic architecture including at least one pumping device positioned in a fluid pathway within the housing;

an electronic control system housed in the housing, the electronic control system comprising:

at least one processor configured to control operation of the at least one pumping device; and

a communication module configured to receive at least one external input; and

at least one pressure sensing device configured to sense fluid pressure in the implantable fluid-operated inflatable device and communicate the sensed pressure to the electronic control system.

2. The implantable fluid-operated expandable device of claim 1, wherein the reservoir is bonded to an outer surface of the housing.

3. The implantable fluid-operated expandable device of claim 1 or 2, wherein the reservoir comprises a bellows structure configured to contract when fluid is expelled from the reservoir and expand when fluid flows into the reservoir.

4. The implantable fluid-operated expandable device of claim 3, wherein the reservoir is contained within the housing and includes a bellows structure configured to contract when fluid is expelled from the reservoir and expand when fluid flows into the reservoir, the implantable fluid-operated expandable device further comprising: a closed bellows within the housing, wherein the closed bellows is filled with a compressible fluid such that the closed bellows is configured to contract in response to expansion of the reservoir and expand in response to contraction of the reservoir.

5. The implantable fluid operated inflatable device of any one of claims 1-4, 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 pumping device in response to the received user input.

6. The implantable fluid-operated expandable device of claim 5, wherein the electronic control system is configured to: adjusting operation of the at least one pumping device to reduce pressure at the expandable member and initiate deflation of the expandable member in response to detecting a signal generated by interaction of a magnet with the electronic control system, the magnet being positioned corresponding to the fluid-controlled expandable device for a preset period of time.

7. The implantable fluid operated inflatable device of any one of claims 1-4, wherein the electronic control system is configured to control operation of the at least one pumping device in response to user input comprising at least one of:

pressure fluctuations detected by the at least one sensing device in response to a tap input or a drag input; or alternatively

A motion event detected by a motion detection device in the fluid operated inflatable device or the external device.

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

9. The implantable fluid-operated expandable device of claim 8, wherein the preset sequence comprises:

a wake-up sequence to wake up the fluid operated inflatable device comprising a first sequence of taps defined by a first number of taps in a first mode; and

an activation sequence corresponding to the user input includes a second sequence of taps defined by a second number of taps in a second mode.

10. The implantable fluid operated inflatable device of any one of claims 1-9, wherein the electronic control system is configured to monitor a pressure level in the fluid controlled inflatable device and to control operation of the at least one pumping device in response to detected pressure fluctuations, comprising:

in response to detecting that the expandable member is in an expanded state for greater than a preset period of time, controlling the at least one pumping device to reduce pressure at the expandable member and deflate the expandable member;

in response to detecting an increase or decrease in pressure having a duration less than a preset time period, controlling the at least one pumping device to maintain a current state of the fluid-controlled inflatable device; and

In response to detecting a change in atmospheric conditions, the at least one pumping device is controlled to maintain a current state of the fluid-controlled inflatable device.

11. The implantable fluid operated expandable device of any one of claims 1-10, wherein the electronic control system is configured to:

detecting a fault in the fluid-controlled inflatable device in response to detecting that a set pressure is reached for more than a set period of time or that the set pressure is not reached;

outputting an alarm of the detected failure to the external device; and

isolating the fluid from the area where the fault is detected.

12. The implantable fluid operated expandable device of any one of claims 1-11, wherein the at least one pumping device comprises 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, wherein:

in the compact-up mode of operation,

the first piezoelectric pump is configured to operate to pump fluid from the expandable member to the reservoir while the second piezoelectric pump is in a standby mode; and is also provided with

Vibrations generated by operation of the first piezoelectric pump are harvested by the second piezoelectric pump in a standby mode for conversion into energy; and

In the expanded mode of operation,

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; and is also provided with

Vibrations generated by operation of the second piezoelectric pump are harvested by the first piezoelectric pump in a standby mode for conversion into energy; and

in a standby mode of the fluid-operated inflatable device in which both the first piezoelectric pump and the second piezoelectric pump are in a standby mode, vibrations due to movement of a patient in which the fluid-operated inflatable device is implanted are harvested by the first piezoelectric pump and the second piezoelectric pump for conversion into energy.

13. The implantable fluid-operated expandable device of claim 1, wherein the fluidic architecture comprises:

a first unidirectional pump and a first passive valve positioned in a first fluid passageway to selectively create and control fluid flow in a first direction from the expandable member to the reservoir;

a second unidirectional pump and a second passive valve positioned in a second fluid passageway to selectively create and control fluid flow in a second direction from the reservoir to the expandable member;

A first sensing device positioned to sense fluid pressure at the reservoir;

a second sensing device positioned to sense fluid pressure at the expandable member; and

an active valve positioned in accordance with the expandable member, wherein,

in a first mode, the active valve is configured to close by the electronic control system in response to detecting a pressure spike at the expandable member to prevent deflation of the expandable member; and is also provided with

In a second mode, the active valve is configured to be opened by the electronic control system in response to detecting a loss of power to the electronic fluid control system to allow deflation of the inflatable member.

14. The implantable fluid-operated expandable device of claim 1, wherein the fluidic architecture comprises:

a first unidirectional pump positioned in the first fluid passageway and configured to generate a flow of fluid in a first direction from the expandable member to the reservoir;

a second unidirectional pump positioned in a second fluid passageway and configured to create a flow of fluid in a second direction from the reservoir to the expandable member;

A first passive valve positioned in the first fluid path between the first unidirectional pump and the reservoir to restrict fluid flow in the first direction in the first fluid path and prevent backflow of fluid in the first fluid path when the second unidirectional pump is in an operational mode and the first unidirectional pump is in a standby mode;

a second passive valve positioned in the second fluid path between the second unidirectional pump and the reservoir to restrict fluid flow in the second direction in the second fluid path and prevent backflow of fluid in the second fluid path when the first unidirectional pump is in an operational mode and the second unidirectional pump is in a standby mode;

a first sensing device positioned to sense fluid pressure at the reservoir; and

a second sensing device positioned to sense fluid pressure at the expandable member.

15. The implantable fluid-operated expandable device of claim 1, wherein the fluidic architecture comprises:

a first combined pump and valve device positioned in a first fluid passageway to selectively create and control fluid flow in a first direction from the expandable member to the reservoir;

A first sensing device positioned to sense fluid pressure at the reservoir;

a second combined pump and valve device positioned in a second fluid path to selectively create and control fluid flow in a second direction from the reservoir to the expandable member; and

a second sensing device positioned to sense fluid pressure at the expandable member.

16. An implantable fluid-operated inflatable device, comprising:

a fluid reservoir;

an inflatable member;

an electronic fluid control system coupled between the fluid reservoir and the expandable member and configured to control fluid between the fluid reservoir and the expandable member, the electronic fluid control system comprising:

a housing;

a fluid control system housed in the housing, the fluid control system comprising a fluidic architecture including a pumping device positioned in a fluid pathway within the housing;

an electronic control system housed in the housing, the electronic control system comprising:

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; and

At least one pressure sensing device configured to sense fluid pressure in the implantable fluid-operated inflatable device and communicate the sensed pressure to the electronic control system.

17. The implantable fluid-operated expandable device of claim 16, wherein the reservoir is bonded to an outer surface of the housing.

18. The implantable fluid-operated expandable device of claim 16, wherein the reservoir includes a bellows structure configured to contract when fluid is expelled from the reservoir and expand when fluid flows into the reservoir.

19. The implantable fluid-operated expandable device of claim 18, wherein the reservoir is contained within the housing.

20. The implantable fluid-operated expandable device of claim 19, further comprising: a closed bellows within the housing, wherein the closed bellows is filled with a compressible fluid such that the closed bellows is configured to contract in response to expansion of the reservoir and expand in response to contraction of the reservoir.

21. The implantable fluid-operated expandable device of claim 16, wherein the electronic control system is configured to: user input is received from the external device and operation of the at least one pumping device is controlled in response to the received user input.

22. The implantable fluid-operated expandable device of claim 21, wherein the electronic control system is configured to: adjusting operation of the at least one pumping device to reduce pressure at the expandable member and initiate deflation of the expandable member in response to detecting a signal generated by interaction of a magnet with the electronic control system, the magnet being positioned corresponding to the fluid-controlled expandable device for a preset period of time.

23. The implantable fluid-operated inflatable device of claim 16, wherein the electronic control system is configured to control operation of the at least one pumping device in response to user input comprising at least one of:

pressure fluctuations detected by the at least one sensing device in response to a tap input or a drag input; or alternatively

A motion event detected by a motion detection device in the fluid operated inflatable device or the external device.

24. The implantable fluid-operated expandable device of claim 23, wherein the tap input comprises a series of taps in a preset sequence detected by a piezoelectric element of the at least one pumping device.

25. The implantable fluid-operated expandable device of claim 24, wherein the pre-set sequence comprises:

a wake-up sequence to wake up the fluid operated inflatable device comprising a first sequence of taps defined by a first number of taps in a first mode; and

an activation sequence corresponding to the user input includes a second sequence of taps defined by a second number of taps in a second mode.

26. The implantable fluid-operated expandable device of claim 16, wherein the electronic control system is configured to monitor a pressure level in the fluid-controlled expandable device and to control operation of the at least one pumping device in response to detected pressure fluctuations, comprising:

in response to detecting that the expandable member is in an expanded state for greater than a preset period of time, controlling the at least one pumping device to reduce pressure at the expandable member and deflate the expandable member;

in response to detecting that the spike in pressure has a duration less than a preset time period, controlling the at least one pumping device to maintain a current state of the fluid-controlled inflatable device; and

In response to detecting a change in atmospheric conditions, the at least one pumping device is controlled to maintain a current state of the fluid-controlled inflatable device.

27. The implantable fluid-operated expandable device of claim 16, wherein the electronic control system is configured to:

detecting a fault in the fluid-controlled inflatable device in response to detecting that a set pressure is reached for more than a set period of time or that the set pressure is not reached;

outputting an alarm of the detected failure to the external device; and

isolating the fluid from the area where the fault is detected.

28. The implantable fluid-operated expandable device of claim 16, wherein the at least one pumping device comprises 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, wherein:

in the compact-up mode of operation,

the first piezoelectric pump is configured to operate to pump fluid from the expandable member to the reservoir while the second piezoelectric pump is in a standby mode; and is also provided with

Vibrations generated by operation of the first piezoelectric pump are harvested by the second piezoelectric pump in a standby mode for conversion into energy; and

In the expanded mode of operation,

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; and is also provided with

Vibrations generated by the operation of the second piezoelectric pump are harvested by the first piezoelectric pump in a standby mode for conversion into energy.

29. The implantable fluid-operated expandable device of claim 28, wherein in a standby mode of the fluid-operated expandable device in which both the first piezoelectric pump and the second piezoelectric pump are in a standby mode, vibrations due to movement of a patient in which the fluid-operated expandable device is implanted are harvested by the first piezoelectric pump and the second piezoelectric pump for conversion into energy.

30. The implantable fluid-operated expandable device of claim 16, wherein the fluidic architecture comprises:

a first unidirectional pump and a first passive valve positioned in a first fluid passageway to selectively create and control fluid flow in a first direction from the expandable member to the reservoir;

a second unidirectional pump and a second passive valve positioned in a second fluid passageway to selectively create and control fluid flow in a second direction from the reservoir to the expandable member;

A first sensing device positioned to sense fluid pressure at the reservoir;

a second sensing device positioned to sense fluid pressure at the expandable member; and

an active valve positioned in accordance with the expandable member, wherein,

in a first mode, the active valve is configured to close by the electronic control system in response to detecting a pressure spike at the expandable member to prevent deflation of the expandable member; and

in a second mode, the active valve is configured to be opened by the electronic control system in response to detecting a loss of power to the electronic fluid control system to allow deflation of the inflatable member.

31. The implantable fluid-operated expandable device of claim 16, wherein the fluidic architecture comprises:

a first unidirectional pump positioned in the first fluid passageway and configured to generate a flow of fluid in a first direction from the expandable member to the reservoir;

a second unidirectional pump positioned in a second fluid passageway and configured to create a flow of fluid in a second direction from the reservoir to the expandable member;

A first passive valve positioned in the first fluid path between the first unidirectional pump and the reservoir to restrict fluid flow in the first direction in the first fluid path and prevent backflow of fluid in the first fluid path when the second unidirectional pump is in an operational mode and the first unidirectional pump is in a standby mode;

a second passive valve positioned in the second fluid path between the second unidirectional pump and the reservoir to restrict fluid flow in the second direction in the second fluid path and prevent backflow of fluid in the second fluid path when the first unidirectional pump is in an operational mode and the second unidirectional pump is in a standby mode;

a first sensing device positioned to sense fluid pressure at the reservoir; and

a second sensing device positioned to sense fluid pressure at the expandable member.

32. The implantable fluid-operated expandable device of claim 16, wherein the fluidic architecture comprises:

a unidirectional pump positioned in the fluid pathway;

a first active valve positioned in the fluid path between the pump and the reservoir and configured to be selectively activated by the electronic control system;

A second active valve positioned in the fluid passageway between the pump and the expandable member and configured to be selectively activated by the electronic control system;

a third active valve positioned in the fluid path between the pump and the reservoir and configured to be selectively activated by the electronic control system;

a fourth active valve positioned in the fluid path between the pump and the expandable member and configured to be selectively activated by the electronic control system, wherein,

in an expansion 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 so that fluid is pumped from the reservoir to the expandable member; and is also provided with

In the deflate mode, the third and fourth active valves are opened by the electronic control system, and the first and second active valves are closed by the electronic control system so that fluid is pumped from the expandable member to the reservoir.

33. The implantable fluid-operated expandable device of claim 16, wherein the fluidic architecture comprises:

A first combined pump and valve device positioned in a first fluid passageway to selectively create and control fluid flow in a first direction from the expandable member to the reservoir;

a first sensing device positioned to sense fluid pressure at the reservoir;

a second combined pump and valve device positioned in a second fluid path to selectively create and control fluid flow in a second direction from the reservoir to the expandable member; and

a second sensing device positioned to sense fluid pressure at the expandable member.

34. The implantable fluid-operated expandable device of claim 16, wherein the fluidic architecture comprises:

a first piezoelectric pump and valve arrangement positioned in a first fluid path, wherein the first piezoelectric pump and valve arrangement is configured to selectively generate and control fluid flow in a first direction from the expandable member to the reservoir and to sense fluid pressure at the reservoir; and

a second piezoelectric pump and valve arrangement positioned in a second fluid path, wherein the second piezoelectric pump and valve arrangement is configured to selectively generate and control fluid flow in a second direction from the reservoir to the expandable member and to sense fluid pressure at the expandable member.

35. The implantable fluid-operated expandable device of claim 16, wherein the fluidic architecture comprises:

a pump;

a first three-way valve positioned between the pump and the reservoir, the first three-way valve having a first port thereof open to maintain fluid communication with the pump; and

a second three-way valve positioned between the pump and the expandable member, the second three-way valve having a first port thereof open to maintain fluid communication with the pump, wherein,

in the compact-up mode of operation,

the second port of the first three-way valve is opened, the third port of the first three-way valve is closed,

to direct fluid flow from a first port of the first three-way valve to a second port thereof; and

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 of the second three-way valve to the second port thereof; and in the expanded mode of operation,

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 of the first three-way valve to the third port thereof; 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 of the second three-way valve to the third port thereof.