KR20230147702A - Fluid control system for implantable inflatable devices - Google Patents

Abstract

An implantable fluid-operated device can include a fluid reservoir configured to retain fluid, an inflatable member, and a pump assembly configured to transport fluid between the fluid reservoir and the inflatable 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 one or more sensing devices. The electronic control system may include internal components on which the implanted device is installed and external components that can be operated by a user to provide user input and receive output from the implanted device.

Description

Fluid control system for implantable inflatable devices

Cross-reference to related applications

This application claims priority as a continuation of U.S. Provisional Application No. 17/655,958, filed March 22, 2022, entitled “Fluid Control System for Implantable Inflatable Device,” which is entitled Claims priority to U.S. Provisional Application No. 63/200,739, filed March 25, 2021, entitled “Fluid Control System for Implantable Inflatable Device,” the disclosures of which are incorporated herein in their entirety. Incorporated by reference.

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

technology field

The present invention relates generally to body implants, and more particularly to body implants comprising pumps.

Active implantable fluid-operated devices often include one or more pumps that regulate the flow of fluid between different parts of the implantable device. One or more valves may be positioned within the fluid passageway of the device to direct and control the flow of fluid to achieve expansion, deflation, pressurization, decompression, activation, deactivation, etc. of the different fluid-filled implant components of the device. In some implantable fluid-operated devices, sensors may be used to monitor fluid pressure and/or fluid volume within the fluid passageway of the device. Accurate monitoring of conditions within the device, including pressure monitoring and flow monitoring, can provide improved control of device operation, improved diagnostics, and improved efficacy of the device. Additionally, sensors may be used to monitor external conditions of the device, including acceleration, angle, barometric pressure, and temperature, which may facilitate determination of the operating mode of the device.

In a general aspect, 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 inflatable member and configured to control fluid between the fluid reservoir and the inflatable member. The electrofluidic control system includes a housing; a fluid control system housed within a housing including a fluidic structure including at least one pump and at least one valve located in a fluid passageway within the housing; and an electronic control system housed within 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. Additionally, the implantable fluid-operated inflatable device may include at least one pressure sensing device configured to sense fluid pressure within the implantable fluid-operated inflatable device and transmit the sensed pressure to an electronic control system.

In some implementations, the reservoir is bonded to the exterior surface of the housing. In some embodiments, the reservoir includes a bellows structure configured to contract when fluid is released from the reservoir and to expand as fluid flows into the reservoir. In some implementations, the reservoir is housed within a housing. In some embodiments, a closed bellows is provided within the housing, and 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 to expand in response to contraction of the reservoir.

In some implementations, the electronic control system is configured to receive user input from an external device and control operation of at least one pump and at least one valve in response to the received user input. In some embodiments, the electronic control system regulates the operation of the at least one pump and the at least one valve, by interaction of a magnet with the electronic control system positioned correspondingly to the fluid-controlled inflation device for a preset time. and configured to reduce pressure in the inflatable member and initiate deflation of the expandable member in response to detection of the generated signal. In some implementations, the electronic control system includes a change in pressure detected by at least one sensing device in response to a tapping input or a tugging input; or a movement event detected by a motion sensing device of the fluid-operated inflatable device or an external device. The tapping input may comprise a series of tappings in a preset sequence detected by a piezoelectric element of at least one pump or at least one valve. A wake-up sequence for waking up the fluid-operated inflatable device, wherein the preset sequence includes a first tapping sequence defined by a first number of tappings in a first pattern; and an activation sequence corresponding to the user input, including a second tapping sequence defined by a second tapping number of the second pattern.

In some embodiments, the electronic control system monitors the pressure level of the fluid controlled inflatable device and, in response to detection of the inflatable member in an inflated state for a longer than a preset time, reduces the pressure on the inflatable member and inflates the device. configured to control the operation of the at least one pump and the at least one valve in response to the detected fluctuation in pressure, including controlling the at least one pump and the at least one valve to retract the retractable member; controlling at least one pump and at least one valve to maintain the current state of the fluid-controlled inflatable device in response to detection of a spike in pressure having a duration shorter than a preset time; and configured to control the at least one pump and the at least one valve to maintain a current state of the fluid-controlled inflatable device in response to detection of a change in atmospheric conditions.

In some embodiments, the electronic control system detects a failure of the fluid-controlled inflatable device in response to detecting that the set pressure is reached beyond a set time or the set pressure cannot be reached; outputs an alarm of a detected failure to an external device; and is configured to isolate the fluid from the area of the detected failure.

In some implementations, the at least one pump includes a first piezoelectric pump in a first fluid channel of the fluidic structure and a second piezoelectric pump in a second fluid channel of the fluidic structure. In the deflation mode, 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 standby mode, wherein vibrations generated by operation of the first piezoelectric pump are converted into energy. It can be harvested by a second piezoelectric pump in standby mode for conversion. In the expansion mode, while the first piezoelectric pump is in standby mode, the second piezoelectric pump is configured to operate to pump fluid from the reservoir to the expandable member, and the vibrations generated by operation of the second piezoelectric pump are converted into energy. Can be harvested by the first piezoelectric pump in standby mode for conversion of . In the standby mode of the fluid-actuated inflatable device, where both the first and second piezoelectric pumps are in standby mode, vibrations generated due to movement of the patient implanted with the fluid-actuated inflatable device are used for conversion into energy. It can be harvested by a first piezoelectric pump and a second piezoelectric pump.

In some embodiments, the fluidic structure includes a first one-way pump and a first passive valve positioned in the first fluid passageway to selectively generate and control fluid flow in a first direction from the inflatable member toward the reservoir; a second one-way pump and a second manual valve positioned in the second fluid passageway to selectively generate and control fluid flow in a second direction from the reservoir toward the expandable member; a first sensing device positioned to sense fluid pressure in the reservoir; and a second sensing device positioned to sense fluid pressure in the inflatable member; and an active valve positioned in line with the inflatable member. In a first mode, the active valve may be configured to close by an electronic control system in response to detection of a pressure spike in the inflatable member to prevent deflation of the inflatable member. In a second mode, the active valve may be configured to open by electronic control in response to detection of a loss of power to the electronic fluid control system to allow deflation of the inflatable member.

In some embodiments, the fluidic structure includes a first unidirectional pump positioned in the first fluid passageway and configured to produce fluid flow in a first direction from the inflatable member toward the reservoir; a second unidirectional pump positioned in the second fluid passageway and configured to produce fluid flow in a second direction from the reservoir toward the inflatable member; a first unidirectional pump to restrict fluid flow in the first direction in the first fluid passageway and prevent fluid backflow in the first fluid passageway while the second unidirectional pump is in an operating mode and the first unidirectional pump is in a standby mode; and a first passive valve located in the first fluid passageway between the reservoirs; a second unidirectional pump to restrict fluid flow in the second direction of the second fluid passageway and prevent fluid backflow in the second fluid passageway while the first unidirectional pump is in an operating mode and the second unidirectional pump is in a standby mode; and a second manual valve located in a second fluid passageway between the reservoirs; a first sensing device positioned to sense fluid pressure in the reservoir; and a second sensing device positioned to sense fluid pressure in the inflatable member.

In some embodiments, the fluidic structure includes a unidirectional pump located in the fluid passageway; a first active valve located in the fluid passageway between the pump and the reservoir and configured to be selectively activated by an electronic control system; a second active valve located in the fluid passageway between the pump and the expandable member and configured to be selectively activated by an electronic control system; a third active valve located in the fluid passageway between the pump and the reservoir and configured to be selectively activated by an electronic control system; and a fourth active valve within the fluid passageway between the pump and the expandable member and configured to be selectively activated by an electronic control system. In the expansion mode, the first active valve and the second active valve are opened by an electronic control system, and the third active valve and the fourth active valve are closed by an electronic control system so that fluid is pumped from the reservoir to the expandable member. In the deflation mode, the third active valve and the fourth active valve are opened by the electronic control system, and the first active valve and the second active valve are closed by the electronic control system so that fluid is pumped from the expandable member to the reservoir.

In some embodiments, the fluidic structure includes a first coupled pump and valve device positioned in the first fluid passageway to selectively generate and control fluid flow in a first direction from the inflatable member toward the reservoir; a first sensing device positioned to sense fluid pressure in the reservoir; a second coupled pump and valve device positioned in the second fluid passageway for selectively generating and controlling fluid flow in a second direction from the reservoir toward the expandable member; and a second sensing device positioned to sense fluid pressure in the inflatable member.

In some embodiments, the fluidic structure is a first piezoelectric pump and valve device located in a first fluid passageway, the fluid being configured to selectively generate and control fluid flow in a first direction from the inflatable member toward the reservoir and from the reservoir. a first piezoelectric pump and valve device configured to sense fluid pressure; and a second piezoelectric pump and valve device located in the second fluid passageway, the second piezoelectric pump and valve device configured to selectively generate and control fluid flow in a second direction from the reservoir toward the inflatable member, and to sense fluid pressure in the inflatable member. 2 Includes piezoelectric pump and valve device. In some embodiments, the fluidic structure includes a pump; a first three-way valve positioned between the pump and the reservoir and having a first port open to maintain fluid communication with the pump; and a second three-way valve positioned between the pump and the inflatable member, the second three-way valve having a first port open to maintain fluid communication with the pump. In the deflation mode, the second port of the first three-way valve is open and the third port of the first three-way valve is closed, directing fluid flow from the first port to the second port of the first three-way valve, and The second port of the second three-way valve is open and the third port of the second three-way valve is closed to direct flow from the first port to the second port of the second three-way valve. 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 to the third port of the first three-way valve, and the fluid 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 flow from the first port to the third port of the second three-way valve.

1 is a block diagram of an implantable fluid-operated inflatable device according to one aspect.
2A and 2B depict an exemplary implantable fluid-operated inflatable device according to one aspect.
Figure 3 is a schematic diagram of the fluidic architecture of an implantable fluid-operated inflatable device according to one aspect.
4 is a schematic diagram of an exemplary electrofluidic control system for an implantable fluid-operated inflatable device.
FIG. 5 is a schematic diagram of a first example fluidic structure of the example fluid control system shown in FIG. 4 ;
FIG. 6 is a schematic diagram of a second example fluidic structure of the example fluid control system shown in FIG. 4.
FIG. 7 is a schematic diagram of a third exemplary fluidic structure of the exemplary fluid control system shown in FIG. 4 ;
FIG. 8 is a schematic diagram of a fourth exemplary fluidic structure of the exemplary fluid control system shown in FIG. 4 ;
FIG. 9 is a schematic diagram of a fifth exemplary fluidic structure of the exemplary fluid control system shown in FIG. 4 ;
FIG. 10 is a schematic diagram of a sixth exemplary fluidic structure of the exemplary fluid control system shown in FIG. 4.
FIG. 11 is a schematic diagram of a seventh exemplary fluidic structure of the exemplary fluid control system shown in FIG. 4 ;
12A-12C are schematic diagrams of exemplary implantable fluid-actuated inflatable devices according to one aspect.
13A and 13B are schematic diagrams of an exemplary implantable fluid-actuated inflatable device according to one aspect.

Detailed implementation examples are disclosed herein. However, it is understood that the disclosed embodiments are examples only, and that they may be embodied in various forms. Accordingly, the specific structural and functional details disclosed herein should not be construed as limiting, but merely as a basis for the claims and, in fact, for the purpose of variously adapting the embodiments to any suitable detailed structure, as will be understood by those skilled in the art. It should be interpreted as a representative basis for teaching to technicians. Additionally, the terms and phrases used herein are not limiting but are intended to provide an understandable explanation of the disclosure.

As used herein, singular terms are defined as one or more than one. As used herein, the term “other” is defined as at least second or higher. As used herein, the terms “comprising” and/or “having” are defined as “comprising” (i.e., open transition phrases). As used herein, the terms “coupled” or “removably coupled” are defined as “connected,” but are not necessarily directly and mechanically connected.

Generally, embodiments relate to body implants. Hereinafter, the terms patient or user may be used to refer to a person who benefits from a medical device or method disclosed in this disclosure. For example, a patient may be a person whose body has been implanted with a medical device according to the present disclosure or with a method disclosed to operate a medical device according to the present disclosure.

1 is a block diagram of an exemplary implantable fluid-operated inflatable device 100. The exemplary device 100 shown in FIG. 1 includes a fluid reservoir 102, an inflatable member 104, and one or more pumps configured to transfer fluid between the fluid reservoir 102 and the inflatable member 104. and a fluid control system 106 including fluid engineering components such as valves or the like. Fluid control system 106 may include one or more sensing devices that sense conditions, such as fluid pressure, fluid flow rate, etc., within the fluid system of device 100, for example. In some implementations, example device 100 includes electronic control system 108. The electronic control system 108 may monitor and/or control the operation of the various fluidic components of the fluid control system 106 and/or communicate with one or more sensing device(s) within the implantable fluid actuated inflatable device 100. may provide communication and/or communication with one or more external device(s). In some examples, electronic control system 108 may include, for example, a processor, memory, communication module, power storage device, or battery, sensing devices such as an accelerometer, and an implantable fluid-actuated inflatable device. and other such components configured to provide operation and control of 100. For example, the communication module may provide communication with one or more external devices, such as external controller 120. External controller 120 may receive user input, e.g., via a user interface, and transmit user input to electronic control system 108, e.g., via a communications module, for processing, operation, and control of device 100. It can be configured to transmit. Electronic control system 108 may transmit operating information to external controller 120 through a communication module. Through this, the operating state of the inflatable device 100 may be provided to a user, for example, through a user interface, or diagnostic information may be provided to a doctor. In some examples, external controller 120 includes a power transfer module that provides charging of components of internal electronic control system 108. In some examples, transmission of power for recharging the internal electronic control system 108 is provided to an external device separate from the external controller 120. In some implementations, external controller 120 may include sensing devices such as pressure sensors, accelerometers, and other such sensing devices. An external pressure sensor in external controller 120 may, for example, provide local atmospheric or operating pressure to internal electronic control system 108, allowing inflatable device 100 to compensate for changes in pressure. The accelerometer of the external controller 120 may provide detected patient movement to the internal electronic control system 108 for control of the inflatable device 100 . Fluid reservoir 102, inflatable member 104, and fluid control system 106 may be implanted internally within a patient's body. In some implementations, electronic control system 108 is coupled or integrated into the housing of fluid control system 106. In some implementations, at least a portion of electronic control system 108 is physically separate from fluid control system 106. In some implementations, some modules of electronic control system 108 are coupled or integrated into fluid control system 106 and some modules of electronic control system 108 are separate from fluid control system 106. For example, in some implementations, some modules of electronic control system 108 are external (such as external controller 120) in communication with other modules of electronic control system 108 included within implantable device 100. Included with the device. In some embodiments, operation of implantable fluid-operated inflatable device 100 may be manually controlled.

In some examples, electronic monitoring and control of fluid-operated inflatable device 100 may provide improved patient control of the device, improved patient comfort, and improved patient safety. In some examples, electronic monitoring and control of fluid-actuated device 100 may provide the opportunity to customize the operation of device 100 by a physician without additional surgical intervention. The fluidic structures that define the flow and control of fluid through the fluid-operated inflatable device 100, including the arrangement of fluidic components such as pumps, valves, sensing devices, etc., allow the device 100 to effectively respond to user input. To be able to respond, to the state inside the inflatable device 100 (changes in pressure, flow rate, etc.) and the state outside the inflatable device 100 (pressure spikes due to physical activity, shock, etc., continuous changes in atmospheric conditions) Allows rapid and effective adaptation to changes in pressure (changes in pressure, and other changes in external conditions).

The exemplary implantable fluid-operated inflatable device 100 may be representative of various types of implantable fluid-operated devices. For example, device 100 shown in FIG. 1 may include an artificial urinary sphincter 100A as shown in FIG. 2A, an inflatable penile prosthesis 100B as shown in FIG. 2B, and an inflatable, pressurized, deflated, It may represent other such implantable inflatable devices that rely on control of fluid flow to components of the device to achieve decompression, deactivation, etc.

The exemplary artificial urinary sphincter 100A shown in FIG. 2A includes a fluid control system 106A that includes fluidic components such as pumps, valves, sensing devices, etc. located in a fluid passageway and a reservoir (106A) through the fluidic components. and an electronic control system 108A configured to provide fluid transfer between 102A) and inflatable cuff 104A. The fluidic components of fluid control system 106A and the electronic components of electronic control system 108A may be housed within housing 110A. First conduit 103A connects first fluid port 107A of fluid control system 106A/electronic control system 108A contained within housing 110A with reservoir 102A. Second conduit 105A connects second fluid port 109A of fluid control system 106A/electronic control system 108A contained within housing 110A with inflatable cuff 104A.

The exemplary penile prosthesis 100B shown in FIG. 2B includes a fluid control system 106B that includes fluidic components such as pumps, valves, sensing devices, etc. located in a fluid passageway, and a fluid reservoir through the fluidic components. and an electronic control system 108B configured to provide fluid transfer between 102B) and the expandable cylinder 104B. The fluidic components of fluid control system 106B and the electronic components of electronic control system 108B may be housed within housing 110B. A first conduit 103B connects the reservoir 102B and the first fluid port 107B of the fluid control system 106B/electronic control system 108B contained within the housing 110B. One or more second conduits 105B connect one or more second fluid ports 109B of the fluid control system 106A/electronic control system 108A contained within the housing with the expandable cylinder 104B.

The principles described herein utilize various fluidic components to provide transfer of fluid between different fluid-filled implantable components to achieve inflation, deflation, pressurization, decompression, deactivation, occlusion, etc. for effective operation. Applications may also be made to these and other types of implantable fluid-actuated inflatable devices that rely on a pump assembly comprising: The exemplary devices 100A and 100B shown in FIGS. 2A and 2B include electronic control systems 108A and 108B to provide monitoring and control of pressure and/or fluid flow through each device 100A and 100B. Includes. Some of the principles described herein may also be applied to manually controlled implantable fluid-actuated inflatable devices.

As described above with respect to FIG. 1 , the fluid control system 106 may be one located within the fluid circuit of the pump assembly, for example, to control the transfer fluid between the fluid reservoir 102 and the inflatable member 104. It may include a pump assembly including one or more valves and one or more pumps. 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 with fluid channels formed therein to form a fluid circuit. In instances where the pump assembly is electronically driven and/or controlled, the manifold may be an enclosed manifold capable of receiving and dividing the flow of fluid from the electronic components of the pump assembly to prevent leakage and/or gas exchange. It may be possible. In some examples, the pump assembly includes one or more pressure sensing devices within the fluid circuit to provide relatively precise monitoring and control of fluid flow and/or fluid pressure within the fluid circuit and/or the inflatable member. A fluidic circuit configured in this manner can facilitate appropriate inflation, deflation, pressurization, decompression, and deactivation of components of an implantable fluid-actuated device to provide patient safety and device efficacy.

3 is a schematic diagram of an exemplary fluidic structure for an implantable fluid-operated inflatable device, according to one aspect. The fluidic structure of the implantable fluid-operated inflatable device may include fluid channels, valve(s), pressure sensor(s), and other components in orientations other than those shown in FIG. 3 . Fluidic structures capable of accommodating backpressure, pressure surges, etc. improve the performance, efficacy and efficiency of fluid operated device 100.

The exemplary fluidic structure 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 fluid channel controls the flow of fluid produced by the first pump P1 from the inflatable member 104 to the reservoir 102 . A second valve (V2) in the second fluid channel controls the flow of fluid produced by the second pump (P2) from the reservoir (102) to the inflatable member (104). The first sensing device S1 senses the fluid pressure in the reservoir 102 and the second sensing device S2 senses the fluid pressure in the inflatable member 104 . The first and second sensing devices S1 and S2 may provide monitoring of fluid flow and/or fluid pressure within the fluid channel. In the arrangement shown in Figure 3, while one of the first pump (P1) or the second pump (P2) is activated, the other of the first pump (P1) or the second pump (P2) is in standby mode, The first and second pumps (P1, P2) usually do not operate simultaneously. The operation of the first and second pumps (P1, P2) and the first and second valves (V1, V2) (between open and closed states) is determined by means of the first and second sensing devices (S1, S2). Based on the sensed conditions (e.g., fluid pressure and/or fluid flow rate) within the first and second fluid channels within the region proximate to the inflatable member 104 and the reservoir 102, the control system (e.g., fluid pressure and/or fluid flow rate) as described above: 108).

For example, with the first valve (V1) open (and with the second pump (P2) in standby mode and the second valve (V2) closed) operation of the first pump (P1) may be performed using an inflatable member. A contraction of (104) can be provided. The first pump (P1) continues until the pressure sensed by the second sensing device (S2) (co-line with the inflatable member (104)) indicates that the desired contracted state of the inflatable member (104) has been achieved ( The operation continues (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 and P2 may be placed in standby mode and both the first and second valves V1 and V2 may be closed. The 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) is performed using the inflatable member ( 104) can provide expansion. The second pump (P2) continues 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 To maintain the inflation state, both the first and second pumps (P1, P2) can be placed in standby mode and both the first and second valves (V1, V2) can be closed. Valves V1 and V2 may provide selective sealing of each fluid channel(s) to maintain the configured state of the fluid operated device. Interaction with the valves V1 and V2 (and corresponding changes in fluid flow through the fluidic structure of the device) can change the set state of the fluidically actuated device. Valves (V1, V2) that maintain the device's set state until the patient requests a change in the device's set state and initiate the requested change in the device's set state provide improved patient safety and improved device efficacy.

In some examples, one or more of the valves included in the fluidic structure are normally open valves. Normally open valves are open by default and close (and remain closed) in response to the application of power. The use of normally open valves in the exemplary arrangement shown in FIG. 3 may, for example, in the event of a power failure or other system failure resulting in loss of control of pumps (P1, P2) and/or valves (V1, V2). Failsafe measures can be provided. For example, with expandable member 104 inflated, valves V1 and V2 closed, and pumps P1 and P2 on standby, the loss of power resulting in this type of loss of control ( or other system failure) may cause patient discomfort and/or compromise patient safety. Using normally open valves in a fluidic structure allows the valves V1 and V2 to open in the event of a power loss, relieve pressure from the expandable member 104, and allow the fluid in the system to reach equilibrium. there is.

In some examples, one or more of the valves included within the fluidic structure may be normally closed valves, which are in a default closed state and open (and remain open) in response to the application of power. Normally closed may not provide the failsafe measures described above, depending on the location of the normally closed valve within the fluid engineering structure. However, the use of one or more normally closed valves in the fluidic structure can reduce the power consumption of the fluid-operated inflatable device 100. Many valves included in the fluidic structure remain closed for significantly more time than in the open state (e.g., to maintain the current state of the fluid-operated inflatable device 100). Because normally closed valves are closed by default and do not rely on the application of power to remain closed, the use of one or more normally closed valves in a fluidic construction may reduce power consumption (as compared to normally open valves). when compared to use). This may extend the life of the fluid-operated inflatable device 100, reduce the amount of physician intervention required for continued operation (e.g., to replace power cells), and/or reduce recharge requirements, and/or Alternatively, the interval between recharges can be increased.

To reduce the amount of pumping required to achieve a desired level of deflation of the inflatable member 104, power consumption may be reduced through passive movement of fluid through the fluidic channels of the fluid-operated inflatable device 100. For example, in an expanded state, the pressure of inflatable member 104 is greater than the pressure of reservoir 102. In the exemplary arrangement shown in FIG. 3 , to achieve the desired level of deflation of the inflatable member 104, the first valve (V1) is activated (without activation of the first pump (P1), and the second valve (V2) can be opened to allow fluid to naturally flow out of the inflatable member 104 (with the second pump P2 closed and in standby mode). The first pump (P1) operates by passively flowing fluid out of the inflatable member (104) based on the fluid pressure sensed by the first and/or second sensing devices (S1, S2). It can be activated to relieve any unrelieved residual pressure.

In some examples, a pressure sensing device (e.g., sensing devices S1, S2 shown in the example fluidic structure shown in FIG. 3) measures the pressure of the fluidic structure of the fluidically actuated inflatable device 100. It can support a variety of ways to regulate, measure and control, and can be positioned to provide monitoring of fluid pressure in reservoir 102 and inflatable member 104. For example, the sensing devices S1, S2 (and/or other pressure sensing devices) detect surges or spikes in fluid pressure at various locations within the fluid-operated inflatable device 100 and, accordingly, pump P1, P2) and valves V1, V2 may be positioned to maintain the current state of the fluid operated inflatable device 100 and/or provide patient comfort and safety.

For example, fluid reservoir 102A of the exemplary artificial urinary sphincter 100A described above with respect to FIG. 2A is located within the patient's abdominal cavity. Accordingly, a pressure sensing device (such as first sensing device S1) located in fluid reservoir 102A may 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, for example, by increasing the pressure of the inflatable cuff 104A. The patient can maintain continence through pressure spikes.

In an example comprising a first sensing device S1 in reservoir 102A and a second sensing device S2 in inflatable cuff 104A, the pressure measurements taken by each of sensors S1 and S2 are, e.g. For example, it can be used to determine how much pressure is needed in inflatable cuff 104A to offset a spike in pressure in reservoir 102A.

As mentioned above, in the expanded state, the pressure of the expandable member 104 is greater than the pressure of the reservoir 102. The pressure difference between inflatable member 104 and reservoir 102 may be used for manual deflation of inflatable member 104. As the fluid within the inflatable device 100 reaches equilibrium, sensing devices S1 and S2 positioned in the reservoir 102 and the inflatable member 104 as shown in the exemplary fluidic structure of FIG. 3 ) can be used to determine when to engage the first pump (P1) to maximize energy conservation, while also managing the transition time from the expanded state of the inflatable member 104 to the desired deflated level. You can. In some examples, positioning of the first and second sensing devices S1 and S2 as shown may provide for detection of blockages, slow leaks, etc. within the fluidic structure, and the system may be configured to compensate for the detected failure. The pumps (P1, P2) and valves (V1, V2) can be operated.

In the exemplary arrangement shown in FIG. 3 , to achieve the desired level of deflation of the inflatable member 104, the first valve (V1) is activated (without activation of the first pump (P1), and the second valve (V2) can be opened to allow fluid to naturally flow out of the inflatable member 104 (with the second pump P2 closed and in standby mode). The first pump (P1) operates by passively flowing fluid out of the inflatable member (104) based on the fluid pressure sensed by the first and/or second sensing devices (S1, S2). It can be activated to relieve any unrelieved residual pressure.

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

FIG. 5 illustrates an example electrofluidic control system 400 including a fluid control system 106 with a first example fluidic structure 410 . The first example fluidic structure 410 includes a first pump (P1) and a first valve (V1) that control the flow of fluid in a first direction from the inflatable member (104) to the reservoir (102). a second pump (P2) and a second valve (V2) that control the flow of fluid in a second direction from ) to the inflatable member (104). In the first example fluidic structure 410 shown in Figure 5, the first pump (P1) is a unidirectional pump and the first valve (V1) restricts the flow in the first fluid channel and allows flow only in the first direction. It is a manual check valve that allows. The second pump (P2) is a unidirectional pump, and the second valve (V2) is a passive check valve that limits flow in the second fluid channel and allows flow only in the second direction. The first sensing device S1 is positioned to sense fluid pressure in the reservoir 102 and the second sensing device S2 is positioned to sense fluid pressure in the inflatable member 104 . First and second manual check valves (V1, V2) arranged as shown for the first and second pumps (P1, P2) prevent backflow of fluid through the pumps (P1, P2). The first example fluidic structure 410 includes an active valve (AV) positioned in line with the inflatable member 104 . An active valve (AV) positioned as shown may respond to a sudden spike in pressure in the inflatable member 104 due to, for example, impact, physical activity, falling, etc., allowing fluid to flow into the inflatable member 104. It is possible to prevent reverse leakage through the first pump P1 and unintentional contraction of the expandable member 104.

FIG. 6 shows an example electrofluidic control system 400 including a fluid control system 106 with a second example fluidic structure 420 . The second exemplary fluidic structure 420 includes a first pump (P1) and a first valve (V1) that control the flow of fluid in a first direction from the inflatable member (104) to the reservoir (102), and a reservoir ( It includes a second pump (P2) and a second valve (V2) that control the flow of fluid in a second direction from 102) to the inflatable member 104. In the second example fluidic structure 420 shown in FIG. 6 , the first pump (P1) is a unidirectional pump and the first valve (V1) restricts the flow in the first fluid channel and directs the flow in the first direction. It is a manual check valve that only allows The second pump (P2) is a unidirectional pump, and the second valve (V2) is a passive check valve that limits flow in the second fluid channel and allows flow only in the second direction. The first sensing device S1 is positioned to sense fluid pressure in the reservoir 102 and the second sensing device S2 is positioned to sense fluid pressure in the inflatable member 104 . A first manual check valve (V1), arranged as shown with respect to the first pump (P1), prevents the reverse flow of fluid through the first pump (P1) and the accidental flow of fluid from the expandable member (104) to the reservoir (102). Prevents phosphorus flow. A second manual check valve (V2) arranged as shown prevents backflow of fluid through the second pump (P2).

FIG. 7 shows an example electrofluidic control system 400 including a fluid control system 106 with a third example fluidic structure 430 . A third exemplary fluidic structure 430 includes a first pump (P1) and a first valve (V1) that control the flow of fluid in a first direction from the inflatable member (104) to the reservoir (102), and a reservoir ( It includes a second pump (P2) and a second valve (V2) that control the flow of fluid in a second direction from 102) to the inflatable member 104. In a third exemplary fluidic structure 430, the first pump (P1) is a unidirectional pump and the first valve (V1) is a passive check that limits flow in the first fluid channel and only allows flow in the first direction. It's a valve. The second pump (P2) is a unidirectional pump, and the second valve (V2) is a passive check valve that limits flow in the second fluid channel and allows flow only in the second direction. The first sensing device S1 is positioned to sense fluid pressure in the reservoir 102 and the second sensing device S2 is positioned to sense fluid pressure in the inflatable member 104 . First and second manual check valves (V1, V2) arranged as shown for the first and second pumps (P1, P2) prevent backflow of fluid through the pumps (P1, P2). A third exemplary fluidic structure 430 includes an active valve (AV) positioned to act as a failsafe in the event of power loss. In the arrangement of components shown in the third exemplary fluidic structure, the active valve (AV) may be a normally open valve. In the event of a loss of power to the electrofluidic control system 400, the active valve (AV) will open to allow the inflatable member 104 to decompress, thus providing patient comfort and safety.

FIG. 8 shows an example electrofluidic control system 400 including a fluid control system 106 with a fourth example fluidic structure 440 . A fourth exemplary fluidic structure 440 uses one pump (P2) and four active valves (AV1, AV2, AV3, AV4) to transfer fluid between reservoir 102 and expandable member 104. Hire. In an example where the active valve is a piezoelectric valve, the first, second, third and fourth active valves (AV1, AV2, AV3, AV4) can be actively and selectively opened and closed in response to selective application of voltage. there is. By actively opening the first active valve (AV1) and the second active valve (AV2) and actively closing the third active valve (AV3) and the fourth active valve (AV4), fluid flows through the expandable member (104). It may be pumped from reservoir 102 to inflatable member 104 for expansion. By actively closing the first active valve (AV1) and the second active valve (AV2) and actively opening the third active valve (AV3) and the fourth active valve (AV4), fluid flows through the expandable member (104). It can be pumped from the expandable member 104 to the reservoir 102 to deflate it.

9 shows an example electrofluidic control system 400 including a fluid control system 106 with a fifth example fluidic structure 450. The fifth exemplary fluidic structure 440 employs one pump (P1) as does the fourth exemplary fluidic structure 440. The fifth exemplary fluidic structure 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, LV2). In the fifth exemplary fluidic configuration, the port 1 on the first latching valve LV1 and the port 1 on the second latching valve LV2 are always open. Upon activating the first latching valve LV1, one of the other ports 2 or 3 of the first latching valve LV1 can communicate with the open port 1. Similarly, upon activating the second latching valve LV2, one of the other ports 2 or 3 of the second latching valve LV2 may communicate with the open port 1. By selecting ports 2 on both the first latching valve LV1 and the second latching valve LV2, when the port 3 of each of the first latching valve LV1 and the second latching valve LV2 is closed. , fluid can flow between ports 1 and 2, allowing pump P1 to transfer fluid from inflatable member 104 to reservoir 102. Similarly, by selecting the port 3 (and therefore the closing port 2) of each latching valve LV1, LV2, fluid can flow between ports 1 and 3, and the pump can thereby Allows transfer of fluid from reservoir 102 to inflatable member 104.

FIG. 10 shows an example electrofluidic control system 400 including a fluid control system 106 with a sixth example fluidic structure 460 . A sixth exemplary fluidic structure includes a first pump (P1) that generates fluid flow in a first direction from the inflatable member (104) to the reservoir (102), and a first pump (P1) that generates fluid flow in a first direction from the inflatable member (104) to the inflatable member (104). It includes a second pump (P2) that generates fluid flow in two directions. In the sixth exemplary fluidic structure 460 shown in Figure 10, the first pump (P1) and the second pump (P2) are a combined pump and valve device. For example, when the first pump P1 is in standby mode, not operating/pumping, the first pump P1 prevents the flow of fluid through the first fluid channel. Similarly, when the second pump P2 is in standby mode, not operating/pumping, the second pump P2 prevents the flow of fluid through the second fluid channel.

FIG. 11 shows an example electrofluidic control system 400 including a fluid control system 106 with a seventh example fluidic structure 470 . A seventh exemplary fluidic structure includes a first pump (P1) that generates fluid flow in a first direction from the inflatable member (104) to the reservoir (102), and a first pump (P1) that generates fluid flow in a first direction from the inflatable member (104) to the inflatable member (104). It includes a second pump (P2) that generates fluid flow in two directions. In the seventh exemplary fluidic structure 470 shown in FIG. 11 , the first pump P1 and the second pump P2 are pumps as in the sixth exemplary fluidic structure 460 shown in FIG. 10 . and a valve device, thereby selectively restricting flow through the fluid channel between the reservoir 102 and the inflatable member 104 in addition to creating fluid flow through the fluid channel. However, in the seventh exemplary fluidic structure 470 shown in FIG. 11, the first and second pumps P1 and P2 may be piezoelectric pumps. The piezoelectric element of a piezoelectric pump can sense changes in pressure. Accordingly, in the seventh exemplary fluidic structure 470, the first and second pumps P1, P2 (in the form of piezoelectric pumps) may also function as pressure sensing devices, and thus as shown in the previous fluidic structure. The sensing devices S1 and S2 may be removed. This may simplify the fluid engineering structure of fluid control system 106 and reduce the overall size of electrofluidic control system 400.

Accordingly, in some examples, one or more of the valves included within the fluidic structure of fluid control system 106 may be piezoelectric valves. Piezoelectric materials generate electrical energy when subjected to mechanical strain due to pressure (strain). Conversely, piezoelectric materials deform in response to the application of an electric field. In other words, piezoelectric materials can convert electric charges into movement, and movement into electric charges. These properties allow mechanical valves to be controlled electronically through the application of voltage to the valve. During operation, fluid-operated inflatable device 100 may receive or experience external stimuli, such as vibration. Sources of vibration may include, for example, vibrations caused by operation of one of the pumps, vibrations caused by movement of fluid through the fluid-operated inflatable device 100, movement of the user, and/or other physical activity. , and other such causes internal and external to device 100. Given the ability of the piezoelectric material of the piezoelectric valve to generate an electric potential in response to applied movement, these external stimuli can be converted into energy. In some instances, external stimulation, for example in the form of vibration, may be converted to energy by the pump being in standby mode at the time of receiving the vibration.

As described above with respect to the example fluidic structure shown in FIG. 3 (first valve V1 is open, second pump P2 is in standby mode, and second valve V2 is closed) Actuation of the first pump P1 (in the state) generates fluid flow in a first direction (from the inflatable member 104 towards the reservoir 102 ) for deflation of the inflatable 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) causes expansion of the expandable member 104. generate a fluid flow in the second direction (from the reservoir 102 towards the inflatable member 104). To maintain the set state (i.e., inflated or deflated) of the fluid-operated inflatable device 100, the first and second pumps (P1, P2) are in standby mode and the first and second valves ( V1, V2) are closed.

3, at least one of the pumps P1, P2 will be in standby mode at any given time, thereby collecting stimulation and converting that stimulation into electrical displacement as described above. You will be able to convert it. In this example, one of the pumps (P1 or P2) (the pump in operation) acts as an energy actuator or generator, and the other of the pumps (P1 or P2) (the pump in standby mode) acts as an energy harvester or collector. . The exemplary fluid engineering structure shown in FIG. 3 may include up to four piezoelectric elements, where the pumps P1 and P2 are piezoelectric pumps and the valves V1 and V2 are piezoelectric valves. However, in this example, the pumps P1 and P2 act as actuators and harvesters such that the latching and/or sealing ability of the valves V1 and V2 is not impaired during operation of the fluid operated inflatable device 100.

As mentioned above, during operation of the device 100 in the deflation mode, vibrations generated due to the operation of the first pump P1 are transferred from the first pump P1 to the second pump P2, for example in a fluidic structure. It can be delivered through a manifold in which it 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 received as a movement in the piezoelectric element of the second pump P2. In some situations, hydraulic pressure may also act on the second pump (P2), thereby contributing to the amplitude of the movement experienced by the piezoelectric elements of the second pump (P2) and causing additional energy to be generated by the amplified movement. There will be. During operation in the expansion mode, with the second pump (P2) operating and the first pump (P1) in standby mode, the second pump (P2) operates to pump fluid from the reservoir (102) to the expandable member (104). and the first pump (P1) will harvest the energy generated as a result of the operation of the second pump (P2). In some situations, the user's physical movements can be converted into movements of the piezoelectric elements of the pumps P1 and P2. This 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 is converted to energy that would otherwise be dissipated through device 100 and not used. Accordingly, harvesting and storing energy in this manner can increase the lifespan of the power storage device 130 and increase the operating time of the fluid-operated device 100 without recharging or power source replacement. This may also allow the use of a smaller power storage device 130, thereby reducing the overall size of the electrofluidic control system 400.

As noted above, in some examples, fluid-operated inflatable device 100 (e.g., in the form of artificial urinary sphincter 100A or inflatable penile prosthesis 100B described above) is electronically operated by electronic control system 108. It can be controlled. Electronic control system 108 may communicate with an external controller 120 that may be operated by a user, for example. External controller 120 may receive user input and transmit user input to electronic control system 108 for control of fluid-actuated inflatable device 100. Electronic control system 108 may communicate information, such as device operating status, system alerts, operating conditions, etc., to an external controller 120 for consumption by a user. Rapid and reliable communication between the external controller 120 and the electronic control system 108 facilitates proper functioning and operation of the device 100 under different conditions, throughout the life of the fluid-actuated inflatable device 100. Provides patient comfort and ease of use. Rapid and reliable communication between the external controller 120 and the electronic control system 108 can improve patient safety and allow the fluid-actuated inflatable device 100 to adapt to changes in condition of the patient and /or enable the adoption of fail-safe measures with or without physician intervention.

In some examples, external controller 120 includes a fob specifically tailored for control, monitoring, and interaction with fluid-operated inflatable device 100. In some examples, external controller 120 may be integrated into an external electronic device that can communicate with electronic control system 108 of fluid-operated inflatable device 100. For example, external controller 120 may be implemented in an application executed by an electronic device, such as a smartphone, tablet computer device, etc.

In some situations, communication between the external controller 120 and the electronic control system 108 of the fluid-actuated inflatable device 100 may be initiated by the patient, such that the operation of the fluid-operated inflatable device 100 and Changes in control may be initiated manually. In some situations, electronic control of fluid-operated inflatable device 100 is performed automatically under the control of electronic control system 108.

In some examples, manual control of fluid-operated inflatable device 100 may allow the patient to manually configure settings. For example, in some situations, the patient may find that increasing or decreasing the pressure on the inflatable member 104 may improve comfort and/or operability and/or safety. For example, for the exemplary artificial urinary sphincter 100A, a patient may use external controller 120 to configure pressure settings at inflatable cuff 104A based on observed device performance, physical activity, etc. . For example, if the patient is experiencing some incontinence at the current settings, the patient can use external controller 120 to increase the occlusion pressure setting on inflatable cuff 104A. In some examples, the patient may wish to adjust the pressure setting in the inflatable cuff 104A (e.g., temporarily, during physical activity) due to certain physical activities that may affect urination, and the external controller 120 ) can be used to set a controlled occlusion pressure on the inflatable cuff 104A for a set period of time, allowing the device 100 to revert back to previously stored settings after the set period of time has elapsed.

In some examples, manual control of fluid-actuated inflatable device 100 may be activated by subaudible signals from the patient. In some examples, subaudible signals may be detected by external controller 120 and transmitted to electronic control system 108 for control of fluid operated inflatable device 100. In some examples, an audible signal may be detected by electronic control system 108. In some examples, in response to pressure spikes detected due to tapping, e.g., sequential tapping implemented by a patient and detected by fluid-actuated inflatable device 100, Manual control can be activated. In situations where the external controller 120 is unavailable to the patient for any reason (misplaced, not charged, inoperable, etc.), the fluid actuated inflatable device 100 may adjust the pressure of the inflatable member 104, for example. To do so, it may respond to subaudible signals from the patient. This can improve patient safety and comfort.

In some examples, a configurable number of tabs, e.g., on the patient's torso, at or near the implanted location of the fluid-actuated inflatable device, or at other locations, may be used to manually control the fluid-actuated inflatable device 100. can form a unique sequence or pattern that triggers. This unique sequence or pattern can prevent accidental activation of fluid-actuated inflatable device 100 due to an inadvertent tap detected by device 100. In some examples, the piezoelectric element of the pump or valve can act as a microphone capable of detecting a set audible or sub-audible signal. In some examples, the detected signal may command, for example, a pump or valve to open, and the corresponding displacement produces a measurable current.

In some examples, one or both of the implantable fluid-operated inflatable device 100 and/or external controller 120 includes a motion sensing device, such as, for example, an accelerometer capable of detecting a motion event. do. In some situations, a motion event may cause a change in state within the fluid-actuated inflatable device 100, which may benefit from an adjustment of the operating parameters of the device 100 in response to the motion event. As an example, in the artificial urinary sphincter 100A described above, movements related to events such as coughing, sneezing, lifting, exercising/physical activity, etc. may result in incontinence. Detection of this type of movement event by the accelerometer may trigger, for example, by a processor of electronic control system 108, the execution of an algorithm that increases the pressure in inflatable cuff 104A to Prevents incontinence by providing extra pressure on the urethra during movement events. In some examples, in response to this type of movement event, for example, the need for additional pressure in the inflatable member 104 may be determined based on a change in pressure/pressure fluctuation detected by a sensing device included in the fluidic structure. can be detected. For example, detection of increased intra-abdominal pressure (e.g., due to compression due to coughing or sneezing, bending and/or lifting movements, etc.) may be communicated to reservoir 102, whereby the device The internal pressure of (100) can be increased. The increased pressure in the reservoir 102 detected by one of the sensing devices can be processed by an algorithm executed by the electronic control system such that the operation of the pumps and valves in the fluid system is controlled by the fluid operated inflatable device 100. ) can be adjusted to apply appropriate pressure to the reservoir 102 and the expandable member 104 to maintain the current condition.

In some examples, manual control of fluid-actuated inflatable device 100 may be achieved in situations where external controller 120 is unavailable to the patient for any reason (misplaced, uncharged, inoperable, etc.) using a backup activation device, such as a magnet. It can be implemented by using For example, in situations where an external controller is not available and the patient needs to release pressure on the inflatable cuff 104A of the artificial urinary sphincter 100A, back-up activation at a position corresponding to the implanted device 100A Applying the device/magnet activates a readout switch to control pumps and valves within the fluidic structure to operate to release pressure on the inflatable cuff 104A, thereby allowing the inflatable cuff 104A to open and release the urethra. let it be

In some examples, especially when external controller 120 is not available, manual control of fluid-actuated inflatable device 100 may include manual pressure applied externally to device 100. In some examples, this may include a first sequence of externally applied pressure that acts as a wake-up signal, followed by a second sequence of externally applied pressure that acts as an activation signal. For example, externally applied pressure may be in the form of a tug on the penis that creates pressure fluctuations in the fluid channels of artificial urinary sphincter 100A, particularly near inflatable cuff 104A. In this example, a first tug sequence may wake artificial urinary sphincter 100A and a second tug sequence may signal release of pressure in inflatable cuff 104A such that the cuff opens to release the urethra. , the patient becomes able to defecate. In some instances, this tugging type of pressure can also generate a subaudible signal that can be detected by piezoelectric elements in the pump and valve acting as microphones, as described above.

As previously discussed, in some situations, electronic control of a fluid-operated inflatable device occurs automatically under the control of electronic control system 108. This can allow virtually continuous system monitoring, diagnosis and adjustment, and output of alarms in response to detection of conditions requiring intervention by the patient and/or physician.

In some examples, the electronic control system 108 may perform fluid actuated inflation to detect conditions that may indicate leaks, blockages, etc. that may impair the operation of the device 100 and/or lead to failure of the device 100. The operation of the device 100 may be monitored. For example, electronic control system 108 may monitor the amount of time a particular pressure is reached at a particular location within the fluidic structure. For example, changes in pumping time beyond a set threshold or set range, and/or the inability to reach a certain pressure or a certain pressure range may indicate a leak or blockage within the fluid channel of the fluid-actuated inflatable device 100. It can be expressed. In some examples, the electronic control system 108 may generate an alarm on output, for example via an external controller 120, that may compromise the operation of the device 100 and/or the device. Indicates a possible condition that may result in failure of (100). In some examples, electronic control system 108 may control the operation of pumps and valves to seal fluid within portions of device 100 that do not experience leaks.

In some examples, automatic control of fluid-operated inflatable device 100 includes collection and storage of data for diagnosis by a physician and coordination of patient care protocols. In the case of artificial urinary sphincter (100A), diagnosis often relies on bladder diaries completed manually by the patient. In some examples, the electronic control system 108 of the artificial urinary sphincter 100A may measure and record the number of times per day the patient must urinate, the start to end time for 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 open time of inflatable cuff 104A and/or the amount of closed time of inflatable cuff 104A. 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 for each urination event. Data collected and tracked in this way can be used by doctors for diagnosis and follow-up of treatment.

In some examples, automatic control of fluid-operated inflatable device 100 includes automatic control of pressure in inflatable member 104 and/or reservoir 102 in response to specific conditions. For example, the electronic control system 108 may determine that there has been no communication from the external controller 120 to the implanted fluid-actuated inflatable device 100 for a set period of time (e.g., if the external controller 120 is unavailable or inoperable for some reason). indicating that it is impossible), and/or that the inflatable member 104 has been in an expanded state for a longer period of time than a set time period. In response to detection of this type of condition, the electronic control system 108 may direct the implanted fluid-operated inflatable device 100 to relieve the pressure in the inflatable member 104, for example, as a failsafe measure. ) can relieve the pressure settings within.

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

In some examples, automatic control of fluid-operated inflatable device 100 may include correction of internal device pressure based on atmospheric or barometric pressure detected by an external device, such as external controller 120, and transmitted to electronic control system 108. can be provided. In some examples, identifying atmospheric pressure (and changes in atmospheric pressure) in essentially real time allows electronic control system 108 to automatically operate pumps and valves to adjust the internal pressure of device 100 based on the detected atmospheric pressure. allows control. The ability to automatically adjust device operation to account for changes in atmospheric pressure can ensure that the implanted fluid-operated inflatable device 100 maintains the correct internal pressure even as atmospheric conditions change.

The exemplary implantable fluid-operated inflatable device 100 described above (e.g., in the form of an artificial urinary sphincter 100A and/or an inflatable penile prosthesis 100B) may be configured to provide fluid conduits in an electronic fluid control system 400. and a fluid reservoir (102) connected to the inflatable member (104) by (103, 105) and providing for transfer of fluid between the reservoir (102) and the inflatable member (104). 12A-12C illustrate an exemplary implantable fluid-operated inflatable device with a fluid reservoir coupled to the housing of an electronic fluid control system. 13A and 13B depict an exemplary implantable fluid-operated inflatable device with a fluid reservoir housed within the housing of an electronic fluid control system.

12A-12C are schematic diagrams of an exemplary implantable fluid-operated inflatable device 600. In particular, FIG. 12A is a schematic diagram of a first exemplary implantable fluid-operated inflatable device 600A, FIG. 12B is a schematic diagram of a second exemplary implantable fluid-operated inflatable device 600B, and FIG. 12C is a schematic diagram of a first exemplary implantable fluid-operated inflatable device 600A. 3 Schematic diagram of an exemplary implantable fluid-operated inflatable device 600C. The three exemplary fluid actuated inflatable devices 600A, 600B, 600C shown in FIGS. 12A-12C each have an inflatable member 604 coupled to the electrofluidic control system 640 by a fluid conduit 605. and a fluid reservoir 602 coupled, e.g., directly coupled, to the housing 610 of the electrofluidic control system 640.

As described above with respect to FIGS. 5-11 , example electronic fluid control system 640 is a component included in example electronic fluid control system 400 described above with respect to FIGS. 5-11 , e.g. For example, it may include a power storage device 130, a PCB 140 of electronic control system 108, and a fluid control system 106 including an exemplary fluidic structure housed in housing 110. The principles to be described with respect to exemplary implantable fluid-actuated inflatable devices 600A, 600B, 600C may be used in conjunction with various other types, including, for example, the artificial urinary sphincter 100A described above and the inflatable penile prosthesis 100B. It can be applied to an implantable fluid-operated inflatable device.

The exemplary fluid-operated inflatable device 600A shown in FIG. 12A includes an electrofluidic control system 640 containing electronic and fluidic components as described above, housed in a sealed housing 610. do. Fluid conduit 605 has a first end coupled to inflatable member 604 and a second end extending through a port 620 formed in housing 610 to connect to a fluid control system housed in housing 610. Including, providing for the transfer of fluid to and from the inflatable member 704. In the arrangement shown in FIG. 12A , reservoir 602A is coupled to a top surface portion of sealed housing 610 (example orientation shown in FIG. 12A ) or to a transverse plane of sealed housing 610 . In some examples, reservoir 602A is secured, for example glued or bonded, to housing 610. Fluid conduit 603A includes a first end connected to reservoir 602A and a second end extending through port 630A in housing 610 to be connected to a fluid control system contained within housing 610. Provides for the transfer of fluid to and from 602A. This example arrangement can provide a smaller mating surface between the sealed housing 610 and the reservoir 602A, and can accommodate the patient's movements (e.g., than the example arrangement shown in FIG. 12B). can be exposed to lower pressure due to In some examples, a grid (not shown in FIG. 12A) may be placed to surround the exterior of reservoir 602A to prevent external pressure from being applied to reservoir 602A.

The exemplary fluid-operated inflatable device 600B shown in FIG. 12B includes an inflatable member 604 connected to a fluid control system housed in a sealed housing 610 via a fluid conduit 605 as described above. Includes fluid control system 640. An exemplary fluid-operated inflatable device 600B includes a reservoir 602B coupled to a lateral portion of a sealed housing 610 (example orientation shown in FIG. 12B) or to the coronal plane of the housing 610. In some examples, reservoir 602B is secured, for example glued or bonded, to housing 610. Conduit 603B includes 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 contained within housing 610, Provides for transfer of fluid to and from reservoir 602B. In the example arrangement shown in FIG. 12B, reservoir 602B is coupled to the largest surface of housing 610. The larger surface area of reservoir 602B may reduce the required expansion of reservoir 602B (compared to the example arrangement shown in FIG. 12A).

The exemplary fluid-operated inflatable device 600C shown in FIG. 12C includes an inflatable member 604 connected to a fluid control system housed in a sealed housing 610 via a fluid conduit 605 as described above. Includes fluid control system 640. The exemplary fluid-operated inflatable device 600C includes a reservoir 602C having a bellows structure coupled to an upper portion of an enclosed housing 610 (example orientation shown in FIG. 12C). In some examples, a portion of reservoir 602C, such as a bottom portion, is secured to housing 610, such as glued or bonded, such that the remaining portion of the bellows structure forming reservoir 602C is allowed to expand and contract. make it possible Conduit 603C includes 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 contained within housing 610, Provides for transfer of fluid to and from reservoir 602C. The bellows structure of the example reservoir 602C shown in FIG. 12C contracts as fluid is released from reservoir 602C and expands as fluid enters reservoir 602C. The bellows structure of the exemplary reservoir 602C shown in FIG. 12C may include, for example, a titanium polymer material that allows the reservoir 602C to be hermetically sealed to the hermetically sealed housing 610, further providing additional support for the reservoir 602C. Allows a wide range of materials to be used. In some examples, a grid (not shown in FIG. 12C) may be placed to surround the exterior of reservoir 602C to prevent external pressure from being applied to reservoir 602C.

An exemplary two-piece fluid actuated inflatable device (600A, 600B, 600C) comprising an external fluid reservoir (602A, 602B, 602C) attached to a sealed housing (610) may be configured as an overall device ( Reservoirs 602A, 602B, outside of sealed housing 610 with limited resistance, reducing 600) to two components (i.e., inflatable member 604 and housing 610 to which reservoir 602 is attached). 602C) enables expansion and contraction. In some circumstances, this design may reduce the time and complexity of surgical procedures. In some situations, this design may allow the airtight housing 610 to be sealed in place within the patient, thereby reducing intracorporeal drift over the life of the implanted fluid-operated inflatable device 600.

13A and 13B are schematic diagrams of an exemplary implantable fluid-operated inflatable device 700. In particular, FIG. 13A is a schematic diagram of a first exemplary implantable fluid-operated inflatable device 700A, and FIG. 13B is a schematic diagram of a second exemplary implantable fluid-operated inflatable device 700B. The exemplary fluid-operated inflatable devices 700A and 700B shown in FIGS. 13A and 13B each include an inflatable member 704 coupled to an electronic fluid control system 740 by a fluid conduit 705 and an electronic fluid Control system 740 includes a fluid reservoir 702 contained within a sealed housing 710.

As described above with respect to FIGS. 5-11 , example electronic fluid control system 740 is a component included in example electronic fluid control system 400 as described above with respect to FIGS. 5-11 . , may include, for example, a power storage device 130, a PCB 140 of the electronic control system 108, and a fluid control system 106 including an exemplary fluidic structure housed in the housing 110. . The principles to be described in connection with the exemplary implantable fluid-actuated inflatable devices 700A, 700B may be used in various other types of implants, including, for example, the artificial urinary sphincter 100A described above and the inflatable penile prosthesis 100B. It can be applied to fluid-operated inflatable devices.

The exemplary fluid-operated inflatable device 700A shown in FIG. 12A includes an electrofluidic control system 740 containing electronic and fluidic components as described above, housed in a sealed housing 710. do. 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. Including, providing for the transfer of fluid to and from the inflatable member 704. In the arrangement shown in Figure 13A, reservoir 702A is housed within an enclosed housing 710. Because the environment within the sealed housing 710 holds a fixed amount of gas/fluid, a change in volume within the reservoir 702 causes a change in pressure within the sealed housing 710, causing the reservoir 702 to move closer to the sealed housing 710. ) limits the amount that can expand and contract within the The use of a bellows structure for reservoir 702 can alleviate this, especially if the sealed housing 710 is filled with a gas that is relatively easily compressed, for example helium or argon.

The exemplary fluid actuated device 700B shown in FIG. 12B includes a closed bellows 712 within a sealed housing 710. The closed bellows 712 can be filled with a compressible fluid that acts as a sacrificial gas, causing the closed bellows 712 to expand as the reservoir 702 contracts and to contract as the reservoir 702 expands. That is, when fluid flows into reservoir 702 , reservoir 702 (having a bellows structure) expands, and closed bellows 712 contracts in response to the expansion of reservoir 702 . Reservoir 702 contracts as fluid is released from reservoir 702 and closed bellows 712 expands in response to the contraction of reservoir 702.

An exemplary two-component fluid-actuated inflatable device (700A, 700B) comprising an internal fluid reservoir (702) installed within a sealed housing (610) reduces the overall size of the implanted fluid-actuated inflatable device (700). You can do it. In some circumstances, this design may reduce the time and complexity of surgical procedures. In some situations, this design may allow the airtight housing 710 to be sealed in place within the patient, thereby reducing intracorporeal drift over the life of the implanted fluid-operated inflatable device 700.

Although certain features of the described embodiments have been illustrated as described herein, numerous modifications, substitutions, changes and equivalents will now occur to those skilled in the art. Accordingly, it is 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)

An implantable, fluid-operated, inflatable device that:
fluid reservoir;
an inflatable member;
an electronic fluid control system coupled between the fluid reservoir and the inflatable member and configured to control fluid between the fluid reservoir and the inflatable member; and
At least one pressure sensing device configured to sense fluid pressure within the implantable fluid-operated inflatable device and transmit the sensed pressure to an electronic control system;
The electronic fluid control system,
housing;
a fluid control system comprising a fluidic structure housed within the housing and including at least one pumping device located in a fluid passageway within the housing;
comprising an electronic control system housed in the housing,
The electronic control system is,
at least one processor configured to control operation of at least one pumping device; and
Comprising a communication module configured to receive at least one external input,
Implantable fluid-actuated inflatable device. According to paragraph 1,
The reservoir is bonded to an exterior surface of the housing. According to claim 1 or 2,
wherein the reservoir comprises a bellows structure configured to contract when fluid is released from the reservoir and to expand when fluid flows into the reservoir. According to paragraph 3,
The reservoir includes a bellows structure received within the housing and configured to contract when fluid is released from the reservoir and to expand when fluid flows into the reservoir, wherein the implantable fluid-operated inflatable device is enclosed within the housing. An implantable fluid actuated device further comprising a bellows, 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 to expand in response to contraction of the reservoir. Inflatable device. According to any one of claims 1 to 4,
wherein the electronic control system is configured to receive the at least one external input from an external device and control operation of the at least one pumping device in response to the received user input. According to clause 5,
The electronic control system regulates the operation of the at least one pumping device and, in response to detection of a signal generated by the interaction of a magnet with an electronic control system positioned correspondingly to the fluid-controlled inflatable device for a preset time, causes inflation. An implantable fluid-operated inflatable device configured to reduce pressure in an expandable member and initiate deflation of the expandable member. According to any one of claims 1 to 4,
The electronic control system:
a change in pressure detected by at least one sensing device in response to a tapping input or a tugging input; or
A fluid actuated inflation for an implant, configured to control operation of at least one pumping device in response to user inputs including at least one of a motion event detected by a motion sensing device of the fluid actuated inflatable device or an external device. possible device. In clause 7,
The external input comprises a series of tabs in a preset sequence detected by a piezoelectric element of at least one pump. According to clause 8,
The preset sequence is:
a wake-up sequence for waking up the fluid-actuated inflation device, including a first tap sequence defined by a first number of taps in a first pattern; and
An implantable fluid-actuated inflatable device comprising an activation sequence corresponding to a user input, including a second tapping sequence defined by a second number of taps in a second pattern. According to any one of claims 1 to 9,
The electronic control system is configured to monitor pressure levels within the fluid-controlled inflatable device and control operation of at least one pumping device in response to detected fluctuations in pressure, the operation comprising:
in response to detection of an inflatable member in an inflated state for a period longer than a preset period, control at least one pumping device to reduce pressure on the inflatable member and depressurize the inflatable member;
controlling the at least one pumping device to maintain a current state of the fluid-controlled inflatable device in response to detection of an increase or decrease in pressure having a duration shorter than a preset period; and
A fluid-operated inflatable device for implantation, comprising controlling the at least one pumping device to maintain a current state of the fluid-controlled inflatable device in response to detection of a change in atmospheric conditions. According to any one of claims 1 to 10,
The electronic control system:
detecting a failure within the fluid-controlled inflatable device in response to detection of a time to reach a set pressure beyond a set period of time or an inability to reach the set pressure;
outputting an alarm of the detected failure to the external device;
An implantable fluid-operated inflatable device configured to isolate fluid from the area of the detected failure. According to any one of claims 1 to 11,
The at least one pumping device comprises a first piezoelectric pump in a first fluid channel of the fluidic structure and a second piezoelectric pump in a second fluid channel of the fluidic structure,
In contraction mode,
the first piezoelectric pump is configured to operate to pump fluid from the inflatable member to the reservoir while the second piezoelectric pump is in a standby mode;
The vibration generated by the operation of the first piezoelectric pump is harvested by the second piezoelectric pump in standby mode for conversion into energy;
In inflation mode,
the second piezoelectric pump is configured to operate to pump fluid from the reservoir to the inflatable member while the first piezoelectric pump is in a standby mode;
The vibration generated by the operation of the second piezoelectric pump is harvested by the first piezoelectric pump in standby mode for energy conversion;
In the standby mode of the fluid-actuated inflatable device where both the first and second piezoelectric pumps are in standby mode, vibrations generated due to movement of a patient implanted with the fluid-actuated inflatable device are converted into energy. An implantable fluid-operated inflatable device harvested by a first piezoelectric pump and a second piezoelectric pump. 2. The fluid engineering structure of claim 1, wherein:
a first one-way pump and a first manual valve positioned in the first fluid passageway to selectively generate and control fluid flow in a first direction from the expandable member toward the reservoir;
a second one-way pump and a second manual valve positioned within the second fluid passageway to selectively generate and control fluid flow in a second direction from the reservoir toward the expandable member;
a first sensing device positioned to sense fluid pressure in the reservoir;
a second sensing device positioned to sense fluid pressure in the inflatable member; and
comprising an active valve positioned in line with the inflatable member,
the active valve is configured, in a first mode, to be closed by an electronic control system in response to detection of a pressure spike in the inflatable member to prevent deflation of the inflatable member;
wherein the active valve is configured to open by electronic control in response to detection of a loss of power to the electronic fluid control system to allow deflation of the inflatable member in a second mode. 2. The fluid engineering structure of claim 1, wherein:
a first unidirectional pump positioned within the first fluid passageway and configured to generate a flow of fluid from the expandable member in a first direction toward the reservoir;
a second unidirectional pump positioned within the second fluid passageway and configured to generate a flow of fluid in a second direction from the reservoir toward the inflatable member;
To limit fluid flow in the first direction in the first fluid passageway and to prevent backflow of fluid in the first fluid passageway while the second unidirectional pump is in an operating mode and the first unidirectional pump is in a standby mode, a first manual valve located in the first fluid passageway between the one-way pump and the reservoir;
restricting fluid flow in the second direction in the second fluid passageway while the first unidirectional pump is in an operating mode and the second unidirectional pump is in a standby mode, and wherein the first unidirectional pump is in an operating mode and the second unidirectional pump is in a standby mode a second manual valve located in the second fluid passageway between the second one-way pump and the reservoir to prevent backflow of fluid in the second fluid passageway while in the second fluid passageway;
a first sensing device positioned to sense fluid pressure in the reservoir; and
A fluid actuated inflatable device comprising a second sensing device positioned to sense fluid pressure in the inflatable member. According to paragraph 1,
The fluid engineering structure is:
a first coupled pump and valve device positioned within the first fluid passageway and configured to selectively generate and control flow of fluid from the expandable member in a first direction toward the reservoir;
a first sensing device positioned to sense fluid pressure in the reservoir;
a second coupled pump and valve device positioned within the second fluid passageway and configured to selectively generate and control flow of fluid in a second direction from the reservoir toward the inflatable member; and
A fluid actuated inflatable device comprising a second sensing device positioned to sense fluid pressure in the inflatable member. An implantable, fluid-operated, inflatable device that:
fluid reservoir;
an inflatable member;
an electronic fluid control system coupled between the fluid reservoir and the inflatable member and configured to control fluid between the fluid reservoir and the inflatable member; and
At least one pressure sensing device configured to sense fluid pressure within the implantable fluid-operated inflatable device and transmit the sensed pressure to an electronic control system;
The electronic fluid control system,
housing;
A fluid control system comprising a fluidic structure housed within a housing and including a pumping device located in a fluid passageway within the housing;
comprising an electronic control system housed within the housing;
The electronic control system is,
at least one processor configured to control operation of at least one pump and at least one valve; and
An implantable fluid-operated inflatable device comprising a communication module configured to communicate with at least one external device. According to clause 16,
The reservoir is bonded to an exterior surface of the housing. According to clause 16,
wherein the reservoir comprises a bellows structure configured to contract when fluid is released from the reservoir and to expand when fluid flows into the reservoir. According to clause 18,
An implantable fluid-operated inflatable device, wherein the reservoir is received within a housing. According to clause 19,
An implantable fluid actuator, further comprising a closed bellows within the housing, the closed bellows being filled with a compressible fluid, the closed bellows being configured to contract in response to expansion of the reservoir and to expand in response to contraction of the reservoir. Inflatable device. According to clause 16,
wherein the electronic control system is configured to receive user input from an external device and control operation of at least one pumping device in response to the received user input. According to clause 21,
The electronic control system regulates the operation of the at least one pumping device and, in response to detection of a signal generated by the interaction of a magnet with an electronic control system positioned correspondingly to the fluid-controlled inflatable device for a preset time, causes inflation. An implantable fluid-operated inflatable device configured to reduce pressure in an expandable member and initiate deflation of the expandable member. According to clause 16,
The electronic control system may include: a change in pressure detected by at least one detection device in response to a tapping input or a tugging input; or
An implantable fluid-actuated inflatable configured to control operation of at least one pumping device in response to user inputs including at least one of a motion event detected by a motion sensing device of the fluid-actuated inflatable device or an external device. Device. According to clause 23,
wherein the tapping input comprises a series of taps in a preset sequence detected by a piezoelectric element of at least one pumping device. According to clause 24,
The preset sequence is:
a wake-up sequence for waking up the fluid-actuated inflatable device, including a first tap sequence defined by a first number of taps in a first pattern; and
An implantable fluid-actuated inflatable device comprising an activation sequence corresponding to a user input, including a second tapping sequence defined by a second number of taps in a second pattern. According to clause 16,
The electronic control system is configured to monitor pressure levels within the fluid-controlled inflatable device and control operation of at least one pumping device in response to detected fluctuations in pressure, the operation comprising:
in response to detection of an inflatable member in an inflated state for a period longer than a preset period, control at least one pumping device to reduce pressure on the inflatable member and depressurize the inflatable member;
controlling the at least one pumping device to maintain a current state of the fluid-controlled inflatable device in response to detection of a pressure spike having a duration less than a preset period; and
A fluid-operated inflatable device for implantation, comprising controlling the at least one pumping device to maintain a current state of the fluid-controlled inflatable device in response to detection of a change in atmospheric conditions. According to clause 16,
The electronic control system is,
detecting a failure within the fluid-controlled inflatable device in response to detection of a time to reach a set pressure beyond a set period of time or an inability to reach the set pressure;
outputting an alarm of the detected failure to the external device;
An implantable fluid-operated inflatable device configured to isolate fluid from the area of the detected failure. According to clause 16,
The at least one pumping device comprises a first piezoelectric pump in a first fluid channel of the fluidic structure and a second piezoelectric pump in a second fluid channel of the fluidic structure,
In contraction mode,
the first piezoelectric pump is configured to operate to pump fluid from the inflatable member to the reservoir while the second piezoelectric pump is in a standby mode;
The vibration generated by the operation of the first piezoelectric pump is harvested by the second piezoelectric pump in standby mode for conversion into energy;
In inflation mode,
the second piezoelectric pump is configured to operate to pump fluid from the reservoir to the inflatable member while the first piezoelectric pump is in a standby mode;
A fluid-operated inflatable device, wherein the vibrations generated by the operation of the second piezoelectric pump are harvested by the first piezoelectric pump in standby mode for conversion into energy. According to clause 28,
In the standby mode of the fluid-actuated inflatable device where both the first piezoelectric pump and the second piezoelectric pump are in standby mode, vibrations generated due to movement of a patient implanted with the fluid-actuated inflatable device are converted into energy. An implantable fluid-operated inflatable device harvested by the first and second piezoelectric pumps for transduction. 17. The method of claim 16, wherein the fluidic structure:
a first one-way pump and a first manual valve positioned in the first fluid passageway to selectively generate and control fluid flow in a first direction from the expandable member toward the reservoir;
a second one-way pump and a second manual valve positioned within the second fluid passageway to selectively generate and control fluid flow in a second direction from the reservoir toward the expandable member;
a first sensing device positioned to sense fluid pressure in the reservoir;
a second sensing device positioned to sense fluid pressure in the inflatable member; and
comprising an active valve positioned in line with the inflatable member,
In a first mode, the active valve is configured to close by the electronic control system in response to detection of a pressure spike in the inflatable member to prevent deflation of the inflatable member;
In a second mode, the active valve is configured to open by electronic control in response to detection of a loss of power to the electronic fluid control system to allow deflation of the inflatable member. According to clause 16,
The fluid engineering structure is:
a first unidirectional pump positioned within the first fluid passageway and configured to generate a flow of fluid from the expandable member in a first direction toward the reservoir;
a second unidirectional pump positioned within the second fluid passageway and configured to generate a flow of fluid in a second direction from the reservoir toward the inflatable member;
To limit fluid flow in the first direction in the first fluid passageway and to prevent backflow of fluid in the first fluid passageway while the second unidirectional pump is in an operating mode and the first unidirectional pump is in a standby mode, a first manual valve located in the first fluid passageway between the one-way pump and the reservoir;
restricting fluid flow in the second direction in the second fluid passageway while the first unidirectional pump is in an operating mode and the second unidirectional pump is in a standby mode, and wherein the first unidirectional pump is in an operating mode and the second unidirectional pump is in a standby mode a second manual valve located in the second fluid passageway between the second one-way pump and the reservoir to prevent backflow of fluid in the second fluid passageway while in the second fluid passageway;
a first sensing device positioned to sense fluid pressure in the reservoir; and
An implantable fluid-operated inflatable device, comprising a second sensing device positioned to sense fluid pressure in the inflatable member. 17. The method of claim 16, wherein the fluidic structure:
A unidirectional pump located in the fluid passageway;
a first active valve located in the fluid passageway between the pump and the reservoir and configured to be selectively activated by an electronic control system;
a second active valve located in the fluid passageway between the pump and the expandable member and configured to be selectively activated by an electronic control system;
a third active valve located in the fluid passageway between the pump and the reservoir and configured to be selectively activated by an electronic control system;
a fourth active valve in the fluid passageway between the pump and the expandable member and configured to be selectively activated by the electronic control system;
In the expansion mode, the first active valve and the second active valve are opened by the electronic control system and the third active valve and the fourth active valve are closed by the electronic control system so that fluid is pumped from the reservoir to the expandable member;
In the deflation mode, the third active valve and the fourth active valve are opened by the electronic control system and the first active valve and the second active valve are closed by the electronic control system so that fluid is pumped from the inflatable member to the reservoir. For fluid operated inflatable devices. According to clause 16,
The fluid engineering structure is:
a first coupled pump and valve device positioned within the first fluid passageway and configured to selectively generate and control flow of fluid from the expandable member in a first direction toward the reservoir;
a first sensing device positioned to sense fluid pressure in the reservoir;
a second combined pump and valve device positioned within the second fluid passageway and configured to selectively generate and control flow of fluid in a second direction from the reservoir toward the inflatable member; and
An implantable fluid-operated inflatable device, comprising a second sensing device positioned to sense fluid pressure in the inflatable member. According to clause 16,
The fluid engineering structure is:
A first piezoelectric pump and valve device positioned within the first fluid passageway, the first piezoelectric pump and valve device configured to selectively generate and control fluid flow from the inflatable member in a first direction toward the reservoir, and to sense fluid pressure in the reservoir. pump and valve devices; and
a second piezoelectric pump and valve device located within the second fluid passageway, configured to selectively generate and control fluid flow in a second direction from the reservoir toward the inflatable member, and to sense fluid pressure in the inflatable member; An implantable fluid-operated inflatable device comprising a piezoelectric pump and a valve device. According to clause 16,
The fluid engineering structure is:
Pump;
a first three-way valve positioned between the pump and the reservoir and having a first port open to maintain fluid communication with the pump; and
a second three-way valve positioned between the pump and the inflatable member, the second three-way valve having a first port open to maintain fluid communication with the pump;
In contraction mode,
the second port of the first three-way valve is opened and the third port of the first three-way valve is closed to direct fluid flow from the first port to the second port of the first three-way valve;
the second port of the second three-way valve is opened and the 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; and
In inflation mode,
The second port of the first three-way valve is closed and the third port of the first three-way valve is open to direct fluid flow from the first port to the third port of the first three-way valve;
The implantable fluid actuated valve has the second port of the second three-way valve closed and the third port of the second three-way valve open to direct fluid flow from the first port to the third port of the second three-way valve. Inflatable device.

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