Patient control of bodily implant

Abstract

A medical device includes a bodily implant and an external controller. The bodily implant includes a communications module and an inflatable member. The inflatable member of the bodily implant is configured to be disposed in an inflated configuration and in a deflated configuration. The external controller has a communications module configured to communicate with the communications module of the bodily implant. The external controller configured to receive a first input associated with a desired pressure for the inflatable member. The external controller configured to receive a second input different than the first input. The bodily implant being configured to cause the inflatable member to be disposed at the desired pressure in response to the first input and the second input being received by the external controller.

Description

Atty Docket No. 0073-688W01PATIENT CONTROL OF BODILY IMPLANTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of, and claims priority to, U.S. Nonprovisional Patent Application No. 19 / 364,343, filed on October 21, 2025, entitled “PATIENT CONTROL OF BODILY IMPLANT ”, which claims priority to U.S. Provisional Patent Application No. 63 / 712,634, filed on October 28, 2024, entitled “PATIENT CONTROL OF BODILY IMPLANT ”, the disclosures of which are incorporated by reference herein in their entirety.

[0002] This application also claims priority' to U.S. Provisional Patent Application No. 63 / 712,634. filed on October 28, 2024, the disclosure of which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0003] This disclosure relates generally to bodily implants, and more specifically to bodily implants that include a fluid control system and that can be controlled by a patient using an external controller.BACKGROUND

[0004] Active implantable fluid-operated inflatable devices can include one or more pumps that regulate the flow of fluid between different portions of the implantable device. One or more valves can be positioned within fluid passageways of the device to direct and control the flow of fluid to achieve inflation, deflation, pressurization, depressurization, activation, deactivation and the like of different fluid-filled components of the device. For example, flow of fluid may be directed to an inflatable member to place the inflatable member in an inflated configuration. Similarly, flow of fluid may be directed away from the inflatable member to place the inflatable member in a deflated configuration. In some implantable fluid-operated devices, an implantable pumping device may be electrically operated. For example, in some devices, the implantable pumping device may be electrically operated using a device located outside of the body of the patient.Atty Docket No. 0073-688W01

[0005] There is a need for an external controller and control system that would allow a patient to efficiently control an implantable pumping device disposed within the body of the patient.SUMMARY

[0006] According to a general aspect, a medical device includes a bodily implant and an external controller. The bodily implant includes a communications module and an inflatable member. The inflatable member of the bodily implant is configured to be disposed in an inflated configuration and in a deflated configuration. The external controller has a communications module configured to communicate with the communications module of the bodily implant. The external controller configured to receive a first input associated with a desired pressure for the inflatable member. The external controller configured to receive a second input different than the first input. The bodily implant being configured to cause the inflatable member to be disposed at the desired pressure in response to the first input and the second input being received by the external controller.

[0007] In some implementations, the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in the inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member.

[0008] In some implementations, the desired pressure is associated with the inflated configuration of the inflatable member.

[0009] In some implementations, the desired pressure is associated with the inflated configuration, the bodily implant is configured to cause the inflatable member transition from the deflated configuration of the inflatable member to the inflated configuration of the inflatable member such that the inflatable member is disposed at the desired pressure.

[0010] In some implementations, the desired pressure is associated with the deflated configuration of the inflatable member. In some implementations, the desired pressure is associated with the deflated configuration, the bodily implant is configured to cause the inflatable member transition from the inflated configuration of the inflatable member to the deflated configuration of the inflatable member such that the inflatable member is disposed at the desired pressure.Atty Docket No. 0073-688W01

[0011] In some implementations, the external controller is configured to receive a third input different than the first input and different than the second input, the bodily implant being configured to stop a transition of the inflatable member in response to the external controller receiving the third input. In some implementations, the external controller is configured to receive a third input different than the first input and different than the second input, the bodily implant being configured to stop a transition of the inflatable member from the inflated configuration of the inflatable member to the deflated configuration of the inflatable member in response to the external controller receiving the third input. In some implementations, the external controller is configured to receive a third input different than the first input and different than the second input, the bodily implant being configured to stop a transition of the inflatable member from the deflated configuration of the inflatable member to the inflated configuration of the inflatable member in response to the external controller receiving the third input.

[0012] In some implementations, the bodily implant is a penile implant. In some implementations, the bodily implant is an artificial sphincter.

[0013] According to another aspect, a medical device includes a bodily implant having a communications module and an inflatable member, the inflatable member of the bodily implant being configured to be disposed in an inflated configuration and in a deflated configuration; and an external controller having a communications module configured to communicate with the communications module of the bodily implant, the external controller configured to receive a first input associated with a desired time delay, the external controller configured to receive a second input different than the first input, the bodily implant being configured to cause the inflatable member to transition from the deflated configuration of the inflatable member to the inflated configuration of the inflatable member in response to the second input being received by the external controller and after the desired time delay has elapsed since the second input is received by the external controller.

[0014] In some implementations, the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in the inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member.

[0015] In some implementations, the external controller is configured to receive a third input different than the first input and different than the second input, the bodily implant being configured to stop the transition of the inflatable member from the deflatedAtty Docket No. 0073-688W01 configuration of the inflatable member to the inflated configuration of the inflatable member in response to the external controller receiving the third input.

[0016] In some implementations, the bodily implant is a penile implant.

[0017] According to another aspect, a method of controlling a medical device includes providing a first input to an external controller, the first input being associated with an amount of pressure; and providing a second input on the external controller, the second input being different than the first input, to cause an inflatable member of a bodily implant to transition from a deflated configuration to an inflated configuration.

[0018] In some implementations, the method includes providing a third input to the external controller, the third input being different than the first input and different than the second input.

[0019] In some implementations, the method includes providing a third input to the external controller, the third input being different than the first input and different than the second input, to cause the bodily implant to stop a transition of the inflatable member from the deflated configuration to the inflated configuration.

[0020] In some implementations, the bodily implant is a penile implant. In some implementations, the bodily implant is an artificial sphincter.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG. 1 is a block diagram of an implantable fluid-operated inflatable device.

[0022] FIG. 2A illustrates a system including an example implantable fluid- operated inflatable device.

[0023] FIG. 2B illustrates a system including an example implantable fluid- operated inflatable device.

[0024] FIG. 3 is a schematic diagram of a fluidic architecture of an implantable fluid-operated inflatable device.

[0025] FIG. 4A is an exploded view of an example valve device of a fluid control system of a fluid-operated inflatable device.

[0026] FIG. 4B is another exploded view of the example valve device show n in FIG. 4A.

[0027] FIG. 4C is a cross-sectional view of the example valve device show n in FIG. 4A, in a closed position.Atty Docket No. 0073-688W01

[0028] FIG. 4D is a cross-sectional view of the example valve device shown in FIG. 4A, in an open position.

[0029] FIG. 5A is a schematic view of an example valve device including an example auxiliary flow control device, with the example valve device in an open position.

[0030] FIG. 5B is a schematic view of an example valve device including an example auxiliary’ flow control device, with the example valve device in a closed position.

[0031] FIG. 6A is an exploded view of an example pump device of a fluid control system of a fluid-operated inflatable device.

[0032] FIG. 6B is a cross-sectional view of the example pump device shown in FIG. 6A, in an open position.

[0033] FIGS. 7A, 7B, and 7C are cross-sectional views of example pump devices that includes a filter for capturing particulate matter in the fluid flow and / or for blocking the particulate matter from entering certain parts of the fluidic system (e.g., for blocking particulate matter from entering a pump chamber of the device).

[0034] FIG. 8 is a schematic end view of a filter foil.

[0035] FIGS. 9A, 9B, and 9C are cross-sectional views of example pump devices that includes a filter for capturing particulate matter in the fluid flow and / or for blocking the particulate matter from entering certain parts of the fluidic system (e.g., for blocking particulate matter from entering a pump chamber of the device).

[0036] FIG. 10 is a cross-sectional view of the valve device of FIG. 5 A and 5B, but also including a filter located at an end of a second fluid passageway and a filter located within a first fluid passageway.

[0037] FIG. 11 is a flow chart of a method according to an implementation.DETAILED DESCRIPTION

[0038] Detailed implementations are disclosed herein. However, it is understood that the disclosed implementations are merely examples, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the implementations in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting, but to provide an understandable description of the present disclosure.Atty Docket No. 0073-688W01

[0039] The terms “a’' or “an,” as used herein, are defined as one or more than one. The term “another,” as used herein, is defined as at least a second or more. The terms “including” and / or “having,” as used herein, are defined as comprising (i.e., open transition). The term “coupled” or “moveably coupled,” as used herein, is defined as connected, although not necessarily directly and mechanically.

[0040] In general, the implementations are directed to bodily implants. The term patient or user may hereinafter be used for a person who benefits from the medical device or the methods disclosed in the present disclosure. For example, the patient can be a person whose body is implanted with the medical device or the method disclosed for operating the medical device by the present disclosure. The term physician may hereinafter be used for a person who places or implants a device within the body of the patient or otherwise provides instructions or counsel to the patient on how to use the device disposed within the body of the patient.

[0041] An implantable fluid-operated inflatable device may include a fluid control system. In some examples, the fluid control system includes at least one pump and / or at least one valve. In some examples, the components of the fluid control system control the flow of fluid between a fluid reservoir and an inflatable member of the implantable fluid-operated inflatable device, to provide for the inflation / pressurization and deflation / depressurization of the inflatable member. In some implementations, the fluid control system can be electronically-operated.

[0042] For example, the pumps and / or valves of the fluid control system can be electronically-operated by the fluid control system to control the pressure of, and the flow of fluid in, parts of the fluid-operated inflatable device. An electronically-operated fluid control system, in accordance with implementations described herein, can include a plurality of electromechanical devices, such as, piezoelectric devices that operate as pumps or as valves in the system. One or more processors or controllers can control the electromechanical devices.

[0043] FIG. 1 is a block diagram of an example implantable fluid-operated inflatable device 100. The device 100 includes components that are configured to be implanted or disposed within a body of a patient or user and components that are configured to operate and be disposed outside of the body of the patient or user. The implantable portion 101 (the portion that is configured to be disposed within the body of the patient) includes a reservoir 102, an electronic control system 108, a fluid control system 106, and an inflatable member 104. The portions that are configured to beAtty Docket No. 0073-688W01 disposed outside of the body of the patient include a power transmission device 150 and an external controller 120.

[0044] In the example inflatable device 100, the electronic control system 108 may interface with a fluid control system 106. The fluid control system 106 can include fluidics components such as one or more pumps 106 A, one or more valves 106B and the like configured to transfer fluid between the fluid reservoir 102 and the inflatable member 104. The fluid control system 106 can include one or more sensing devices 106C, such as, for example, one or more pressure sensors, one or more flow rate sensors, etc., that sense conditions such as, for example, fluid pressure, fluid flow rate and the like within the fluidics architecture of the inflatable device 100. In some implementations, the electronic control system 108 includes components that provide for the monitoring and / or control of the operation of various fluidics components of the fluid control system 106 and / or communication with one or more sensing device(s) within the implantable fluid-operated inflatable device 100 and / or communication with one or more external device(s). In some examples, the electronic control system 108 includes components such as a processor 108A, a memory 108B. a communication module 108C, a power storage device 108D (e.g., a battery), electronic driver circuity 108E, sensing devices 108F, such as, for example, voltage measurement circuitry7, current measurement circuitry, an accelerometer, and other such components configured to provide for the monitoring, operation, and control of the implantable fluid-operated inflatable device 100, and power transmission circuitry 108G. In some examples, the communication module 108C of the electronic control system 108 may provide for communication with one or more external devices such as, for example, the external controller 120.

[0045] In some examples, the external controller 120 includes components such as, for example, a user interface, a processor, a memory, a communications module, a power transmission module, and other such components providing for operation and control of the external controller 120 and communication with the electronic control system 108 of the inflatable device 100. For example, the memory may store instructions, applications and the like that are executable by the processor of the external controller 120. The external controller 120 may be configured to receive user inputs via, for example, the user interface, and to transmit the user inputs, for example, via the communication module, to the electronic control system 108 for processing, operation, and control of the inflatable device 100. Similarly, the electronic control system 108 may, via the respective communication modules, transmit operational information to theAtty Docket No. 0073-688W01 external controller 120. This may allow operational status of the inflatable device 100 to be provided, for example, through the user interface of the external controller 120, to the user, may allow diagnostics information to be provided to a physician, a technician, and the like. In some implementations, the communications modules are configured to communicate via Bluetooth. In other implementations, the communication modules are configured to communicate via a different method such as via WiFi.

[0046] In some examples, the power transmission module of the external controller 120 provides for charging of the components of the internal electronic control system 108. In some examples, transmission of power for the charging of the internal electronic control system 108 can be, alternatively or additionally, provided by an external power transmission device 150 that is separate from the external controller 120. In some implementations the external controller 120 can include sensing devices such as one or more pressure sensors, one or more accelerometers, and other such sensing devices. In some implementations, a pressure sensor in the external controller 120 may provide, for example, a local atmospheric or working pressure to the internal electronic control system 108, to allow the inflatable device 100 to compensate for variations in pressure. In some implementations, an accelerometer in the external controller 120 may provide detected patient movement to the internal electronic control system 108 for control of the inflatable device 100.

[0047] The fluid reservoir 102, the inflatable member 104. the electronic control system 108 and the fluid control system 106 may be internally implanted into the body of the patient. In some implementations, the electronic control system 108 and the fluid control system 106 are coupled in, or incorporated into, a housing 110. In some implementations, at least a portion of the electronic control system 108 is physically separate from the fluid control system 106. In some implementations, some modules of the electronic control system 108 are coupled to, or incorporated into, the fluid control system 106, and some modules of the electronic control system 108 are separate from the fluid control system 106. For example, in some implementations, some modules of the electronic control system 108 are included in an external device (such as the external controller 120) that is in communication other modules of the electronic control system 108 included within the implantable fluid-operated inflatable device 100.

[0048] The example implantable fluid-operated inflatable device 100 may be representative of a number of different types of implantable fluid-operated devices. For example, the implantable fluid-operated inflatable device 100 shown in FIG. 1 may beAtty Docket No. 0073-688W01 representative of an inflatable penile prosthesis as shown in FIG. 2A. In another example, the implantable fluid-operated inflatable device 100 as shown in FIG. 2B may be representative of an artificial sphincter (such as an artificial urinary sphincter) that includes an inflatable member 204B that forms a loop or cuff. In some implementations, the example implantable fluid-operated inflatable device 100 shown in FIG. 1 may be representative of other types of implantable inflatable devices that rely on the control of fluid flow to components of the device to achieve inflation, pressurization, deflation, depressurization, deactivation, and the like.

[0049] An example system including an example implantable fluid-operated inflatable device 200 in the form of an example inflatable penile prosthesis is show n in FIG. 2A. The example inflatable device 200 includes a fluid control system 206 (similar to the example fluid control system 106 described above with respect to FIG. 1) including fluidics components such as pumps, valves, sensing devices and the like positioned in fluid passageways. In some implementations, the fluid control system includes components such as, for example, one or more fluid control devices, one or more pressure sensors, and other such components. In some implementations, the example inflatable device 200 includes an electronic control system 208 (similar to the example electronic control system 108 described above with respect to FIG. 1) configured to provide for the transfer of fluid between a reservoir 202 (such as the example fluid reservoir 102 described above with respect to FIG 1) and an inflatable member 204 (similar to the example inflatable member 104 described above with respect to FIG. 1) via the fluidics components. In the example shown in FIG. 2A, the inflatable member 204 is in the form of a pair of inflatable cylinders. In the example shown in FIG. 2A, fluidics components of the fluid control system 206. and electronic components of the electronic control system 208 are received in a housing 210. In some implementations, fluidics components of the fluid control system 206, and electronic components of the electronic control system 208 received in the housing 210 together define an electronically controlled fluid manifold 230 that provides for the electronic control of the flow of fluid between the reservoir 202 and the inflatable member 204.

[0050] In the examples shown in FIG. 2A and FIG. 2B, a first conduit 203 connects a first fluid port 205 of the electronically controlled fluid manifold 230 (the fluid control system 206 / electronic control system 208 received in the housing 210) with the reservoir 202. One or more second conduits 207 connect one or more second fluid ports 209 of the electronically controlled fluid manifold 230 (the fluid control systemAtty Docket No. 0073-688W01206 / electronic control system 208 received in the housing 210) with the inflatable member 204 in the form of the inflatable cylinders. In some examples, the electronic control system 208 can communicate with an external controller 220 (similar to the external controller 120 described above with respect to FIG. 1), via respective communication modules.

[0051] In some implementations, an application stored in a memory’ and executed by a processor of the external controller 220 may allow the patient or user to operate, view, monitor and alter operation of the inflatable device 200. For example, the patient or user may be able to use the external controller 220 to cause the inflatable device 200 (or the inflatable member) to be placed in its inflated configuration or may be able to cause the inflatable device 200 (or the inflatable member) to be placed in its deflated configuration.

[0052] In some examples, components of the electronic control system 208 and / or the fluid control system 206 can be charged and / or recharged by a power transmission module of the external controller 220, and / or by a power transmission device 250, that is separate from the external controller 220.

[0053] The principles to be described herein are applicable to the example implantable fluid-operated inflatable device, in the form of the example inflatable penile prostheses shown in FIG. 2A. and to other types of implantable fluid-operated inflatable devices that rely on pumps, valves and / or various fluidics components to provide for the transfer of fluid between the different fluid-filled implantable components to achieve inflation, deflation, pressurization, depressurization, deactivation, occlusion, and the like for effective operation. The example implantable fluid-operated inflatable device 200 shown in FIG. 2A includes an electronic control system 208 to provide for control of the operation of the respective inflatable members 204 in the form of cylinders, and the monitoring and control of pressure and / or fluid flow through inflatable members 204. Some of the principles to be described herein may also be applied to implantable fluid- operated inflatable devices that are manually controlled.

[0054] As noted above, the electronic control system 208 controlling the flow of fluid between the reservoir 202 and the inflatable member 204 for inflation, pressurization, deflation, depressurization and the like of the inflatable member 204 may provide for improved patient control and physician control of the inflatable device 200, improved accuracy in operation of the inflatable device 200, improved patient comfort, improved patient safety, and the like. In some situations, this improved control andAtty Docket No. 0073-688W01 improved accuracy in the operation of the inflatable device 200 may rely on precise operation and control of the components within the fluid control system 206 and / or the electronically controlled fluid manifold 230. Accordingly, in some implementations, the electronically controlled fluid manifold 230 includes a fluid control system 206 having one or more pump and one or more valve devices and one or more sensing devices. Accurate and consistent operation of the components of the pump and / or valve devices may produce the desired accurate flow control, and consistent inflation, deflation, pressurization, depressurization, deactivation, occlusion, and the like for effective operation.

[0055] A fluid control system, in accordance with implementations described herein, can include a pump assembly including, for example, one or more pump devices and valve devices within a fluid circuit of the pump assembly to control the transfer fluid between the fluid reservoir and the inflatable member. In some examples, the pump assembly including the one or more pump devices and valve device(s) is electronically controlled. In an example in which the pump assembly is electronically powered and / or controlled, the pump assembly may include a hermetic manifold that can contain and segment the flow of fluid from electronic components of the pump assembly, to prevent leakage and / or gas exchange. In some examples, the one or more pump devices and valve devices include electric elements that are configured to be electronically actuated to change their shape and thereby to function as a pump or valve. In some examples, the pump assembly includes one or more pressure sensing devices in the fluid circuit to provide for relatively precise monitoring and control of fluid flow and / or fluid pressure within the fluid circuit and / or the inflatable member. A fluid circuit configured in this manner may facilitate the proper inflation, deflation, pressurization, depressurization, and deactivation of the components of the implantable fluid-operated device to provide for patient safety and device efficacy.

[0056] FIG. 3 is a schematic diagram of an example fluidic architecture for an electronically -operated implantable fluid-operated inflatable device, according to an aspect. The fluidic architecture of an implantable fluid-operated inflatable device can include other arrangements of fluidic passageways, pump(s) / valve(s), pressure sensor(s) and other components than the examples shown in FIG. 3.

[0057] The example fluidic architecture shown in FIG. 3 includes a first pump Pl and a first valve VI positioned in a first fluid passageway, between the reservoir 202 and the inflatable member 204, to control the flow of fluid from the reservoir 202 to theAtty Docket No. 0073-688W01 inflatable member 204. The example fluidic architecture shown in FIG. 3 includes a second pump P2 and a second valve V2 positioned in a second fluid passageway, between the inflatable member 204 and the reservoir 202, to control the flow of fluid from the inflatable member 204 to the reservoir 202.

[0058] In example fluidic architecture shown in FIG. 3, the first pump Pl and the first valve V 1 operate to pump fluid from the reservoir 202 to the inflatable member 204 through the first fluid passageway to provide for inflation of the inflatable member 204, while the second valve V2 closes the second fluid passageway to prevent backflow of fluid, back to the reservoir 202. The second pump P2 and the second valve V2 operate to pump fluid from the inflatable member 204 to the reservoir 202 through the second fluid passageway to provide for deflation of the inflatable member 204, while the first valve V 1 closes the first fluid passageway to prevent backflow of fluid to the inflatable member 204.

[0059] In an example implementation, a conduit Cl can connect a section of the second fluid passageway that is downstream of pump P2 and valve V2 to a section of the first fluid passageway, for example, to an inlet portion of pump Pl. Fluid flow through conduit Cl can flush fluid and material out from of the section of the first fluid passageway when fluid is pumped from the inflatable member 204 to the reservoir 202. In an example implementation, a conduit C2 can connect a section of the first fluid passageway that is downstream of pump P 1 and valve V 1 to a section of the second fluid passageway, for example, to an inlet portion of pump P2. Fluid flow through conduit C2 can flush fluid and material out from of the section of the second fluid passageway when fluid is pumped from the reservoir 202 to the inflatable member 204.

[0060] In some implementations, the example fluidic architecture can include one or more pressure sensors 212, 214, 216, each configured to measure a fluid pressure at a point in the system. For example, a first pressure sensor 212 can be connected to a fluidic passageway, conduit, chamber or component located fluidically between the inflatable member 204 and pumps Pl, P2 and valves VI, V2, and can be configured to measure a fluid pressure at this location, which can also serve as a measure of a fluid pressure in the inflatable member(s) 204, because the fluid is essentially incompressible and the conduit between the pressure sensor 212 and the inflatable member(s) 204 can be considered to be free of obstruction. A second pressure sensor 214 can be connected to a fluidic passageway, conduit, chamber or component located fluidically between pump P 1 and valve V 1 and can be configured to measure a fluid pressure at this location.Atty Docket No. 0073-688W01A third pressure sensor 216 can be connected to a fluidic passageway, conduit, chamber or component located fluidically between the reservoir 202 and pumps Pl, P2 and valves VI, V2, and can be configured to measure a fluid pressure at this location, which can also serve as a measure of a fluid pressure in the reservoir, because the fluid is essentially incompressible and the conduit between the pressure sensor 216 and the reservoir 202 can be considered to be free of obstruction. In some implementations one or more of the pressure sensors 212, 214, 216 can be contained with the housing 210.

[0061] FIG. 4A is a partially exploded perspective view of an example valve device 400. FIG. 4B is an exploded perspective view of the example valve device 400. FIGs. 4C and 4D are cross-sectional views of the example valve device 400 shown in FIG. 4A, in an assembled state. The example valve device 400 shown in FIGs. 4A-4D is an example of a fluid control device, or a fluidic component, included in the fluid control system 206 of the example electronically controlled fluid manifold 230 described above.

[0062] In the example arrangement shown in FIGs. 4A-4D, the example valve device 400 includes a base plate 410 defining a base portion of the valve device 400. A diaphragm 420 is positioned on the base plate 410. A piezoelectric element 440 is positioned on the diaphragm 420, with an isolation layer 430 positioned between the diaphragm 420 and the piezoelectric element 440. The piezoelectric element can be electrically powered (e.g., by a battery of in the implantable fluid-operated inflatable device 100) to drive the diaphragm 420 to open and close the valve device 400. The diaphragm 420 can include a thin metal foil, whose shape can be repeatably deformed in response to movement by the piezoelectric element 440. In some implementations, the diaphragm 420 can include titanium material. In some implementations, the diaphragm 420 can include gold material. In some implementations, the diaphragm 420 can include stainless steel material or other alloys. In some implementations, the isolation layer 430 can include a polyamide material that has a high resistivity, for example, a resistivity greater than 1013Ohm-cm to provide electrical isolation between the piezoelectric element 440 and the diaphragm 420.

[0063] In some examples, an epoxy layer 432 provides for the coupling of the isolation layer 430 and the diaphragm 420. In some examples, an epoxy layer 434 provides for the coupling of the piezoelectric element 440 and the isolation layer 430, and the epoxy layers 432, 434 together provide for the coupling of the piezoelectric element 440 to the diaphragm 420. In some implementations, the epoxy layers 432, 434Atty Docket No. 0073-688W01 are not distinct but are part of one epoxy layer. The epoxy layers 432, 434 can be formed from a mixture of different chemicals (e.g.. a resin and a hardener) that, when mixed and cured, react to form a covalent bond and that adhere to surfaces that they contact. Curing of the epoxy can be controlled through selection of the resin and hardener chemicals used in the mixture, selection of the ratio of the chemicals used in the mixture, control of the temperature of the mixture, and application of electromagnetic radiation to the mixture.

[0064] In some examples, one or more electrodes 490 are arranged on the example valve device 400. In the example shown in FIG. 4A, the example valve device 400 includes a pair of electrodes 490 coupled between the isolation layer 430 and the piezoelectric element 440. Application of a voltage to the piezoelectric element 440 causes a deflection or deformation of the piezoelectric element 440 and a corresponding deflection or deformation of the diaphragm 420 coupled thereto.

[0065] In the example arrangement shown in FIGs. 4A-4D, a fluid chamber 480 is defined between the base plate 410 and the diaphragm 420. For example, in some implementations, the diaphragm 420 can be bonded to the base plate 410 at the periphery’ of the diaphragm to form a fluid-tight connection between the base plate 410 and the diaphragm 420. The base plate 410 includes a first opening 411 that provides for communication between a first fluid passageway 413 and the fluid chamber 480. The base plate 410 includes a second opening 412 that provides for communication between a second fluid passageway 414 and the fluid chamber 480. In the example arrangement shown in FIGs. 4A-4D, the base plate 410 includes a recess 415 surrounding the first opening 411, with a seal 450, in the form of an O-ring in the example shown in FIGs. 4A-4D, fitted in the recess 415. In some examples, a top portion of the seal 450 is pressed against the diaphragm 420 in the closed position of the valve device 400, as shown in FIG. 4C to close off the chamber 480 and inhibit the flow of fluid through the example valve device 400, between the first fluid passageway 413 and the second fluid passageway 414 via the chamber 480. In some examples, in which the valve device 400 does not include a seal 450, the diaphragm 420 is seated against the base plate 410 to close off the chamber 480 and inhibit the flow of fluid through the valve device 400. In the open position of the example valve device 400, the base plate 410 and the top portion of the seal 450 are separated, or spaced apart from, the diaphragm 420 due to the deflection of the diaphragm 420. This positioning of the seal 450 and the base plate 410 relative to the diaphragm 420 opens the chamber 480 and allows fluid to flow throughAtty Docket No. 0073-688W01 the example valve device 400, between the first fluid passageway 413 and the second fluid passageway 414 via the fluid chamber 480.

[0066] FIGs. 5 A and 5B are cross-sectional views of the example valve device 400 shown in FIGs. 4A-4D, including an example flow control device 500 positioned in one of the fluid passagew ay s of the example valve device 400.

[0067] FIG. 5A illustrates an example in which the valve device 400 is open, allowing fluid to flow in the direction of the arrows F 1 , through the first fluid passageway 413, into the chamber 480, and out of the valve device 400 through the second fluid passageway 414. The example show n in FIG. 5 A may illustrate an open position of the valve device 400 that allows fluid to flow, for example, from the reservoir 202 to the inflatable member 204 to provide for inflation / pressurization of the inflatable member 204.

[0068] In the example arrangement shown in FIGs. 5A and 5B, the example flow? control device 500 is positioned at the second opening 412 formed in the base plate 410, the second opening 412 providing for fluid communication between the fluid chamber 480 and the second fluid passageway 414. In some examples, the flow control device 500 is a check valve, or a one-way valve, that allows for flow in one direction (in this example, in the direction of the arrows Fl), while inhibiting flow in the opposite direction.

[0069] FIG. 5B illustrates the closed position of the valve device 400, in which the flow' of fluid through the valve device 400 is blocked. In some examples, the closed position shown in FIG. 5B may maintain an inflation pressure of the inflatable member 204. As described above, in some situations, pressure fluctuations and / or pressure spikes may exert a force, or pressure on the valve device 400 in the closed position. FIG. 5B illustrates a pressure spike, or a back pressure, exerted in the direction of the arrow' F2. In the example described above with respect to FIGs. 4A-4D, this type of pressure spike, or back pressure exerted on the diaphragm 420 / piezoelectric element 440 could cause an unintentional opening of the valve device 400, and an unintentional deflation / depressurization of the inflatable member 204. In the example shown in FIG. 5B, the flow control device 500 (positioned at the second opening 412, between the second fluid passageway 414 and the fluid chamber 480), for example, in the form of a check valve or a one-way valve, remains in the closed position in response to the pressure spike / back pressure / flow of fluid in the direction of the arrow F2. Thus, the positioning of the flow control device 500 at the second opening 412, allowing flow in a firstAtty Docket No. 0073-688W01 direction, i.e., the direction of the arrows Fl, while blocking flow in a second direction, i.e., the direction of the arrow F2, maintains the closed state of the valve device 400, even in response to fluctuation in pressure, or pressure spike, or back pressure.

[0070] The general architecture and principles of operation of the valve device described above also can be used to implement one or more pumps (such as pumps that pumps Pl, P2 of FIG. 3) to pump fluid from one location to another. For example, repeated movement of a diaphragm between an open position and a closed position, relative to a base plate, can cause fluid to be drawn into a chamber formed between the diaphragm and the base plate through a first fluid passageway and expelled out of the chamber into a second fluid passageway. In this manner, fluid can be pumped from a first location that is fluidically connected to the first passageway to a second location that is fluidically connected to the second passageway. In some implementations, one or more one-way valves can be configured to prevent, or limit, the flow of fluid in the direction from the second location to the first location.

[0071] FIG. 6A is a partially exploded perspective view of an example pump device 600, and FIG. 6B is a cross-sectional view of the example pump device 600. The example pump device 600 shown in FIGs. 6A-6B is an example of a fluid control device, or a fluidic component, included in the fluid control system 206 of the example electronically controlled fluid manifold 230 described above.

[0072] In the example arrangement shown in FIGs. 6A-6B. the example pump device 600 includes a base plate 610 defining a base portion of the pump device 600. A diaphragm 620 is positioned on the base plate 610. A piezoelectric element 640 is positioned on the diaphragm 620, with an isolation layer 630 positioned between the diaphragm 620 and the piezoelectric element 640. The piezoelectric element can be electrically powered (e.g., by a battery of the implantable fluid-operated inflatable device 100) to drive the diaphragm 620 to pump fluid through the pump device 600. The diaphragm 620 can include a thin metal foil, whose shape can be repeatably deformed in response to movement by the piezoelectric element 640. In some implementations, the diaphragm 620 can include titanium material. In some implementations, the diaphragm 620 can include gold material. In some implementations, the diaphragm 620 can include stainless steel material or other alloys. In some implementations, the isolation layer 630 can include a polyamide material that has a high resistivity, for example, a resistivity' greater than 1013Ohm-cm to provide electrical isolation between the piezoelectric element 640 and the diaphragm 620.Atty Docket No. 0073-688W01

[0073] In some examples, an epoxy layer 632 provides for the coupling of the isolation layer 630 and the diaphragm 620. In some examples, an epoxy layer 634 provides for the coupling of the piezoelectric element 640 and the isolation layer 630, and the epoxy layers 632, 634 together provide for the coupling of the piezoelectric element 640 to the diaphragm 620. In some implementations, the epoxy layers 632, 634 are not distinct but are part of one epoxy layer. The epoxy layers 632, 634 can be formed from a mixture of different chemicals (e.g., a resin and a hardener) that, when mixed and cured, react to form a covalent bond and that adhere to surfaces that they contact. Curing of the epoxy can be controlled through selection of the resin and hardener chemicals used in the mixture, selection of the ratio of the chemicals used in the mixture, control of the temperature of the mixture, and application of electromagnetic radiation to the mixture.

[0074] In some examples, one or more electrodes 690 are arranged on the example pump device 600. In the example shown in FIG. 6A, the example pump device 600 includes a pair of electrodes 690 coupled between the isolation layer 630 and the piezoelectric element 640. Application of a voltage to the piezoelectric element 640 causes a deflection or deformation of the piezoelectric element 640 and a corresponding deflection or deformation of the diaphragm 620 coupled thereto.

[0075] When the pump device 600 is used in the fluid control system 206 of the example electronically controlled fluid manifold 230 described above, the piezoelectric element 640 can be controlled to cause fluid to be pumped by device 600, for example, by repeatedly changing a volume of the fluid chamber 680 by deforming the deformable diaphragm 620 to pump fluid from the fluid reservoir to the inflatable member.

[0076] In the example arrangement shown in FIGs. 6A-6B, a fluid chamber 680 is defined between the base plate 610 and the diaphragm 620. The base plate 610 includes a first opening 615 that provides for communication between a first fluid passageway 613 and the fluid chamber 680. The base plate 610 includes a second opening 612 that provides for communication between a second fluid passageway 614 and the fluid chamber 680. In some examples, the diaphragm 620 can be actuated to move between a closed position in which the diaphragm 620 is proximate to the base plate 610 due to the deflection of the diaphragm 620, such that the volume of the chamber 680 is minimized, and an open position in which the base plate 610 is separated, or spaced apart from, the diaphragm 620 due to the deflection of the diaphragm 620, such that the volume of the chamber is maximized. When the diaphragm 620 is actuated to move from the closed position to the open position, fluid can be drawn into the chamber 680 throughAtty Docket No. 0073-688W01 the first fluid passageway 613, and when the diaphragm 620 is actuated to move from the open position to the closed position, fluid can be expelled from the chamber 680 through the second fluid passageway 614. Repeatedly actuating the diaphragm between the closed and open position allows fluid to be pumped through the pump device 600, from the first fluid passageway 613 to the second fluid passageway 614 via the fluid chamber 680.

[0077] In some implementations, the pump device 600 can include one or more foil plates 650 and 652 to control the flow of fluid into and out of the pump device 600. The foil plates 650, 652 can include one-way check valves that operate to permit fluid to flow in one direction through the values but not in an opposite direction. The one-way check valves defined by the one or more foil plates can be positioned in, or in fluid connection with, a fluid passageway 613, 614 of the pump device 600. In some examples, a check valve is positioned in, or in fluid connection with, a portion of a fluid passageway 613, 614 so as to inhibit the unintended flow of fluid through the pump device in the event of a fluctuation, or spike in pressure. In some examples, a check valve is positioned in a fluid passageway 613. 614 so as to counteract a back pressure that would otherwise overcome the closing pressure and cause unintentional flow through the pump device 600. In some example implementations, a first check valve defined by one or more foil plates 650. 652 is positioned in, or in fluid connection with (e.g., at a first opening 611 of), a first fluid passageway 613 of the pump device and is configured to permit fluid to easily flow from the first fluid passageway 613 into the chamber 680 but to prevent or inhibit the flow of fluid from the chamber 680 into the passageway 613. In some example implementations, a second check valve defined by one or more foil plates 650, 652 is positioned in, or in fluid connection with (e.g.. at a first opening 612 of), a second fluid passageway 614 of the pump device 600 and is configured to permit fluid to easily flow from the chamber 680 into the second fluid passageway 613 but to prevent or inhibit the flow' of fluid from the passagew ay 613 into the chamber 680.

[0078] Application of an alternating current (AC) voltage to the piezoelectric element 640 can cause the diaphragm 620 of the pump device 600 to oscillate between a first position that defines the closed position of the chamber 680, in which the diaphragm 620 is proximate to the base plate 610 and the volume of the chamber 680 is minimized, and a second (e.g., domed) position that defines the open position of the chamber 680. in which the diaphragm 620 is separated from the base plate and the volume of the chamberAtty Docket No. 0073-688W01680 is maximized. As the diaphragm 620 of the pump device 600 oscillates between a first position and the second position, fluid is drawn into the chamber 680 from the first passageway 613 and is expelled from the chamber 680 into the second passageway 614. As the diaphragm 620 of the pump device 600 oscillates between a first position and the second position, the one-way check valves defined by the one or more foil plates 650, 652 prevent or inhibit fluid from flowing from the chamber 680 into the first passageway 613 and prevent or inhibit fluid from flowing into the chamber 680 from the second passageway 614. Thus, the application of the AC voltage to the piezoelectric element 640 causes the pump device 600 to pump fluid from the first passageway 613 to the second passageway 614.

[0079] The frequency of the AC voltage applied to the piezoelectric element 640 can determine an oscillation mode of the piezoelectric element 640. In some implementations, the frequency of the AC voltage is selected to excite a lowest-order mode in which the center of the circular piezoelectric element 640 experiences the greatest extent of movement during an oscillation cycle, such that an amount of fluid pumped during an oscillation cycle is maximized compared to other oscillation modes.

[0080] The piezoelectric element 640 can be controlled to cause fluid to be pumped by device 600, for example, by repeatedly changing a volume of the fluid chamber 680 by deforming the deformable diaphragm 620 to pump fluid from the fluid reservoir to the inflatable member.

[0081] The volume of the chamber 680 can be determined, at least in part, by the shape, geometry, and material properties of the components used to form the chamber 680, including, for example, the base plate 610 and the deformable diaphragm 620. In some cases, a relatively larger volume of the chamber 680, for an approximately constant diameter of the chamber, can result in more fluid being pumped in each open / close cycle of the pump 600. To achieve a relatively larger volume of chamber 680, the deformable diaphragm can be deformed or biased into a non-flat dome-shaped configuration before it is attached to the piezoelectric element 640.

[0082] In some implementations, before the diaphragm 620 is placed in attached to the piezoelectric element 640, a voltage can be placed across the electrodes 690 attached to the piezoelectric element 640 to configure the piezoelectric element 640 in the domed configuration that is assumes when the fluid chamber is in the open position (See FIG. 4D). Then, the diaphragm can be placed in contact with the piezoelectric element while the piezoelectric element 440 is in its domed configuration, and the epoxyAtty Docket No. 0073-688W01 can be cured when the piezoelectric element and the diaphragm 420 are in the domed configuration, which can reduce stress on the adhesive bond between the diaphragm 420 and the piezoelectric element 440.

[0083] Referring again to FIG. 2A, although considerable effort is expended to maintain the cleanliness of the components of the system and the purity7of the fluid used within the system, it is still possible that some small amounts of foreign matter can contaminate the fluid within the system. For example, when the reservoir 202, the inflatable members 204, and the housing 210 are implanted and connected (e.g., by conduits 203, 207) within a patient, it is possible that some contamination enters the fluidic system. In addition, it is possible that, once implanted within a patient, that small amounts of material disintegrate from walls of the reservoir 202. inflatable member 204, housing 210 and conduits 203, 207 and become suspended within fluid that flows within the inflatable device 200. Because of the small internal dimensions of the pumps and valves used within the fluidic system, the existence of particles of foreign matter suspended within the fluid flowing within the system poses a risk of clogging or damaging one or more of the pumps and valves, which may lead to malfunction of the inflatable device 200. To mitigate the effect of any particulate matter suspended within the fluid that flows within the inflatable device 200, the fluidic path can include one or more filters that block, or reduce the amount of, particulate matter that enters the pumps and valves of the system. In some implementations, the filters can be included in a fluid pathway of a pump or valve.

[0084] FIGs. 7A, 7B, 7C, 9A, 9B, and 9C are cross-sectional views of example pump devices 700 that includes a filter for capturing particulate matter in the fluid flow and / or for blocking the particulate matter from entering certain parts of the fluidic system (e.g., for blocking particulate matter from entering a pump chamber of the device). The example pump device 700 shown in FIGs. 7A, 7B, 7C, 9A, 9B, and 9C are examples of a fluid control device, or a fluidic component, included in the fluid control system 206 of the example electronically controlled fluid manifold 230 described above.

[0085] In the example arrangements shown in FIGs. 7A, 7B, 7C. 9A, 9B, and 9C, the example pump device 700 includes a base plate 702 defining a base portion of the pump device 700. A diaphragm 704 is positioned above the base plate 702, and a fluid chamber 706 is defined between the base plate 702 and the diaphragm 704. A piezoelectric element 708 is positioned on the diaphragm 704. The piezoelectric element can be electrically powered (e.g., by a battery of the implantable fluid-operated inflatableAtty Docket No. 0073-688W01 device) to drive the diaphragm 704 to pump fluid through the pump device 700. The diaphragm 704 can include a thin metal foil, whose shape can be repeatably deformed in response to movement by the piezoelectric element 708. In some implementations, the diaphragm 704 can include titanium material.

[0086] The base plate 702 can define a first fluid passageway 710 through which fluid can flow from a fluid reservoir into the fluid chamber 706. The first fluid passageway 710 can include an opening 712 at a first end of the passageway 710, which is distal to the fluid chamber 706, and can include an opening 714 and a second end of the passageway 710, which is proximate to the fluid chamber 706. The base plate 702 can define a second fluid passageway 720 through which fluid can flow from the fluid chamber 706 to an inflatable member. The second fluid passageway 720 can include an opening 722 at a first end of the passageway 720, which is distal to the fluid chamber 706, and can include an opening 724 and a second end of the passageway 720, which is proximate to the fluid chamber 706. In some implementations, the first fluid passageway 710 and the second fluid passageway 720 can be tapered, such the passageways 710. 720 have larger cross-sectional areas at the ends 712, 722 of the passageways that are distal to the fluid chamber 706 than at ends of the passageways that are proximate to the fluid chamber.

[0087] The pump device 700 can include a first flexible flap 730 that includes a portion that has an area that is greater than an area of the passageway opening 714 that is proximate to the fluid chamber 706 and that covers the opening, such that the first flexible flap 730 is configured to seal against portions of the base plate that defines the opening 714 of the first fluid passageway 710 to close the opening 714 when a fluid pressure in the fluid chamber 706 is greater than a fluid pressure of fluid in the first fluid passageway 710. The flexible flap 730 can be secured to the base plate over a portion of its extent but can have a portion that is unsecured, such that at least a portion of the flexible flap is configured to be pushed away from one or more walls of the fluid passageway 710 that defines the opening 714 when a fluid pressure of fluid in the first fluid passageway 710 is greater than a fluid pressure in the fluid chamber 706. In this manner, the flexible flap 730 operates to allow fluid to flow from the first fluid passageway 710 into the fluid chamber 706 but to block the flow of fluid from the fluid chamber 706 into the first fluid passageway 710. The flexible flap 730 can be made of a variety of materials including, for example, titanium, elastomeric material, plastic material, etc.Atty Docket No. 0073-688W01

[0088] The pump device 700 can include a second flexible flap 732 that includes a portion that has an area that is greater than an area of the passageway opening 724 that is proximate to the fluid chamber 706 and that covers the opening, such that the second flexible flap 732 is configured to seal against portions of the base plate that defines the opening 724 of the second fluid passageway 720 to close the opening 724 when a fluid pressure in the fluid chamber 706 is greater than a fluid pressure of fluid in the second fluid passageway 720. The flexible flap 732 can be secured to the base plate over a portion of its extent but can have a portion that is unsecured, such that at least a portion of the flexible flap is configured to be pushed away from one or more walls of the second fluid passageway 720 that defines the opening 724 when a fluid pressure in the fluid chamber 706 is greater than a fluid pressure of fluid in the second fluid passageway 720. In this manner, the flexible flap 732 operates to allow fluid to flow from the fluid chamber 706 into the second fluid passageway 720 but to block the flow of fluid from the second fluid passageway 720 into the fluid chamber 706. The flexible flap 732 can be made of a variety of materials including, for example, titanium, elastomeric material, plastic material, etc.

[0089] With the flexible flaps 730, 732 configured in this way to allow fluid to flow in a first direction from the first fluid passageway 710 into the fluid chamber 706 and out of the fluid chamber into the second fluid passageway 720 but not in a direction opposite to the first direction, repeated expansion and contraction of the volume of the fluid chamber 706 in response to the piezoelectric element 708 operating on the deformable diaphragm 704 can cause fluid to be pumped from a reservoir fluidically connected to the first fluid passageway 710 to an inflatable member that is fluidically connected to the second fluid passageway 720.

[0090] The pump device 700 can include a fluid filter 740 that is located within, or at the end 712 of, the first fluid passageway 710 or that is located within, or at the end 722 of, the second fluid passageway 720. The fluid filter 740 can operate to block, for example, debris, foreign matter, particulates suspended in the fluid flowing through the device 700 from passing through the first fluid passageway 710 and into the fluid chamber 706 and / or from exiting the second fluid passageway 720. For example, as shown in FIG. 7 A, a fluid filter 740 is located at the opening 712 into the first fluid passageway 710. As shown in FIG. 7B, a fluid filter 740 is located at the opening 722 into the second fluid passageway 720. As shown in FIG. 7C, a fluid filter 740A is locatedAtty Docket No. 0073-688W01 at the opening 712 into the first fluid passageway 710, and a fluid filter 740B is located at the opening 722 into the second fluid passageway 720.

[0091] In some implementations, the fluid filter 740, 740A, 740B can include a metal foil (e.g., a titanium foil, having a pattern of openings that permit fluid to flow through the openings but that block particulates having a characteristic size larger than a threshold size from flowing through the opening. For example, particulates 744 having a charactenstic size (e.g., minimum transverse extent) that is greater than a threshold size defined by the size (e.g., diameter) of the openings can be blocked by the filter 740, while particulates 746 and a characteristic size smaller than the threshold size can pass through the filter 740.

[0092] FIG. 8 is a schematic end view of a filter foil 800. In some implementations, the filter foil 800 can be made of metal (e.g., titanium) and can have a first section 802 that includes a plurality of openings 804. The openings can have a variety' of different shapes, including circular, oblong, square, rectangular, hexagonal, etc. The plurality of openings 804 can be arranged in a regular or irregular pattern. For example, the openings 804 can be arranged in a two-dimensional hexagonal pattern, as shown in FIG. 8, or in a square pattern, or another type of regular or irregular pattern.

[0093] The plurality of openings 804 can be formed in the filter foil 800 in a number of different ways. For example, in some implementations, the pattern of openings can be mechanically stamped into the metal foil 800. In some implementations, the pattern of openings 804 can be laser etched into the metal foil 800. In some implementations, the pattern of openings can be chemically etched (e.g., through a lithographic process) into the metal foil 800.

[0094] Referring again to FIG. 7A and also to FIG. 8, the section 802 that includes the plurality of openings 804 can be arranged on the filter foil 800 so that the pattern of openings 804 is aligned with the opening 712 of the first fluid passageway 710 when the filter foil 800 is attached to the base plate 702. The filter foil 800 also can include an opening 806 in the filter foil that is aligned with the opening 722 of the second fluid passageway 720 of the base plate 702 when the filter foil is attached to the base plate.

[0095] In some implementations, the filter foil 800 can be welded to the base plate 702. For example, when the base plate includes titanium and the filter foil 800 includes titanium, the filter foil 800 can be welded to the titanium base plate 702. Prior to attaching (e.g., welding) the filter foil 800 to the base plate 702, the filter foil 800 canAtty Docket No. 0073-688W01 be positioned relative to the openings 712, 720 in the base plate, such that the first section 802 of the filter foil, which includes the plurality of openings 804, is positioned at the end of the first fluid passageway 710 and such that the opening 806 in the filter foil 800 is positioned at the end of the second fluid passageway 720. Similarly, when a filter foil is attached to the base plate shown in FIG. 7B, a section of the filter foil having a plurality of openings can be aligned with the end of the second fluid passageway 720, and a larger opening in the filter foil 800 in the aligned with the end of the first fluid passageway 710. Similarly, when a filter foil is attached to the base plate shown in FIG. 7C, a first section having a plurality7of openings can be aligned with the end of the second fluid passageway 720 and a second section having a plurality' of openings can be aligned w ith the end of the first fluid passageway 710.

[0096] In implementations in which the first fluid passageway 710 and the second fluid passageway 720 are tapered, such the passageways 710, 720 have larger cross-sectional areas at the ends 712, 722 of the passageways that are distal to the fluid chamber 706 than at ends of the passageways that are proximate to the fluid chamber, filters 740, 740A, 740B positioned at the distal ends of the fluid passageways 710, 720 can have cross-sectional areas that are greater than the cross-sectional areas of the openings 714, 724 between the passageways 710, 720 and the fluid chamber 706. Because of this the area of the filter that is active for trapping particulate matter can be larger than the areas of the openings 714, 724 between the passageway s 710. 720 and the fluid chamber 706. In some implementations the flow of fluid through the filter 740, 740A, 740B can be reversed to dislodge some of the particulate matter that has been trapped by the filters from the filters.

[0097] For example, referring again to FIG. 3, a fluid conduit C 1 can be provided between adownstream side ofvalve V2 and a pump Pl. When the pump Pl is configured similarly to the pump shown in FIG. 7A, with a filter 740 at the end of the fluid passageway 710, the fluid conduit Cl can be connect to the first fluid passageway 710, so that when fluid is pumped from inflatable member(s) 204 to the reservoir 202 some of that fluid is pumped into the fluid passageway 710 of pump P 1. Then, with valve V 1 closed, the fluid that enters the first fluid passageway 710 of pump Pl can flow out of the distal end 712 of the first fluid passagew ay 710 and back to the reservoir 202. The fluid that flows out of the distal end 712 of the first fluid passageway 710 can flush debris and particulate matter out of the filter 740. In some implementations, the conduit Cl can include a one-way valve that allow fluid to pass from valve V2 to pump Pl but not in theAtty Docket No. 0073-688W01 opposite direction. Other such fluid connections, for example, conduit C2 of FIG. 3, can be used to flush debris and particulate matter out of filters used in the fluid control system.

[0098] The example pump devices 700 shown in FIGs. 7A, 7B, 7C include filters 740, 740C for blocking particulate matter in the fluid from entering a pump chamber of the device or for circulating in the fluidic system in which the pump devices operate. The filter 740 shown in FIG. 7A is disposed at the distal end 712 of the first fluid passageway 710, and the filter 740 shown in FIG. 7B is disposed at the distal end 722 of the second fluid passageway 720. These filters 740 can include a plurality of openings in a foil, where the size of the openings is selected to block the passage of particles having a characteristic size greater than a threshold size and to allow fluid and particles having a characteristic size less than the threshold size to pass through the openings.

[0099] In some implementations, the example pump devices 700 shown in FIGs. 7A, 7B, 7C can include filters 740C disposed within the first fluid passageway 710 or within the second fluid passageway 720. for example, between the first end 712 of the first fluid passageway 710 and the opening 714 at the second end of the first fluid passageway 710 and / or between the first end 722 of the second fluid passageway 720 and the opening 724 at the second end of the second fluid passageway 720. For example, as shown in FIG. 7A, the example pump device 700 can include a filter 740C disposed within the first fluid passageway 710. In another example, as shown in FIG. 7B, the example pump device 700 can include a filter 740C disposed within the second fluid passageway 720. In another example, as shown in FIG. 7C, the example pump device 700 can include a filter 740C disposed within the first fluid passagew ay 710 and another filter 740C disposed within the second fluid passageway 720.

[0100] Referring to FIG. 9A, the filter 740C can include an outer frame 750 that supports material within the frame that includes a plurality of small openings or passages through which fluid can pass but which have a threshold size that blocks particles having a characteristic size greater than the threshold size from passing through the filter 740C.

[0101] The outer frame 750 can be secured to the base plate 702 that defines the first fluid passageway 710. In some implementations, the base plate 702 can define a receptacle that receives the outer frame 750. In some implementations, the receptacle can have a lateral extent (e.g., a diameter) that is greater than the lateral extent of the first fluid passageway 710, such that when the outer frame 750 is disposed in the receptacle, an inner wall of the outer frame has a lateral extent that is similar to the lateral extent ofAtty Docket No. 0073-688W01 the first fluid passageway 710. In some implementations, the outer frame can be press fit into the receptacle. In some implementations the outer frame 750 can be welded to the portion of the base plate 702 that defines the receptacle. In some implementations, after the outer frame 750 of the filter 740C is placed in the receptacle, a foil 742 can be placed over the outer frame 750 and then attached (e g., welded) to the base plate 702.

[0102] In different implementations, the outer frame 750 can be made of different materials. For example, if the outer frame 750 is to be welded to a titanium base plate 702, the outer frame 750 can be made of titanium. In another example, if the outer frame 750 is to be securely press fit into a receptacle, the outer frame 750 can be made of a compliant material, for example, plastic, rubber, etc.

[0103] The material of the filter 740C supported by the outer frame 750, which includes a plurality of small openings or passages through fluid passes, can be made of different materials, which need not be identical or similar to the materials of the outer frame 750. For example, the material can include metal (e.g., titanium, gold, etc.). In another example the material can include ceramic material. In another example, the material can include plastic.

[0104] In some implementations, the thickness of the material of the filter, which includes the plurality7of small openings or passages through which fluid passes, in the direction of the fluid flow through the filter can be greater than three times the mean lateral extent of the openings or passages through which the fluid passes. Thus, the openings or passages of the materials can operate more as tubes through which the fluid passes than as apertures in a thin plane of material. In some implementations, walls of the openings or passages of the material can be textured or treated to promote the adhesion of particulate matter, while also permitting the fluid to pass through the openings or passages. For example, the walls of the openings or passages can have a surface texture or roughness that facilitates the adhesion of particulate matter, and the service of the openings or passages can include a hydrophobic coating to encourage the passage of fluid through the openings or passages.

[0105] In addition to being used in the pumps described herein, the filters described herein also can be used in the valves described herein. For example, FIG. 10 is cross-sectional view of the valve device 400 shown in FIG. 5A and 5B, but also including a filter 740 located at an end of the second fluid passageway 414 and a filter 740C located within the first fluid passageway 413. The filters described herein also may be utilized in other valve structures described herein.Atty Docket No. 0073-688W01

[0106] It is desirable that the implantable fluid-operated inflatable device described herein can be implanted in a patient and used to provide safe, reliable, and successful therapeutic treatment to the patient for many years, for example, 10 or more years. It is also desirable that the device does not break or cause injury to the body of the patient in the case of misuse of the device by the patient or in the case of other unintended uses of the device. For example, in a device where the inflatable member is an elongate tubular member and is disposed within a penis or a neophallus of a person, if the person exerts too much pressure or the inflatable member becomes folded or otherwise compromised, it is desirable that the device release the pressure within the inflatable member before the inflatable member breaks or ruptures. Additionally, for example, in a device where the inflatable member is a loop or a cuff (such as in an artificial sphincter device), a physician may unknowingly insert a catheter, and it would be desirable to release the pressure in the inflatable member before the inflatable member breaks or ruptures.

[0107] Accordingly, in some implementations, the piezoelectric elements that are used to operate the pumps and valves of the implantable fluid-operated inflatable devices 100, 200, disclosed herein may be used to release pressure in the inflatable member. For example, in some implementations, the piezoelectric elements may be used to move fluid from the inflatable member 104, 204 to the reservoir 102, 202 when it is detected that there has been a misuse or unintended use of the device. In some cases, the misuse or unintended use is detected by a pressure sensor (pressure sensor detects a high fluidic pressure in the system or in the inflatable member) or the misuse or unintended use may be detected by one of the piezoelectric elements (for example, when a voltage spike occurs on a piezoelectric element).

[0108] Referring back to FIG. 1, the electronic control system 108 drives the piezoelectric elements of the pumps and valves to move fluid within the device. Specifically, in some implementations, the driver circuitry 108E includes a piezoelectric driver that is configured to receive electrical energy’ from the power storage device 108D (a battery) and for generating a waveform of electrical energy that is provided to the piezoelectric elements of the pumps and valves to drive the piezoelectric elements to move the fluid within the system.

[0109] In some implementations, the power storage device 108D (the battery) can provide electrical energy at a maximum voltage of 5 V or less, for example, at a maximum of 4.4 V or less to the piezoelectric driver. The driver can step up the voltageAtty Docket No. 0073-688W01 and can output a waveform having a peak-to-peak voltage of greater than 50 V, for example, 100 V, to the piezoelectric element. In some implementations, the driver can include step up transformer circuitry configured for receiving a first voltage signal from the battery and for outputting a second voltage signal to the piezoelectric element, where the second voltage is greater than the first voltage.

[0110] When the piezoelectric element is associated with a pump of the implantable inflatable device 100, 200, the driver can output a periodic waveform that is used to repeatedly change a volume of a fluid chamber to cause fluid to be pumped through the fluid chamber from one location to another, for example, from a reservoir to an inflatable member or from the inflatable member to the reservoir. In some implementations, a frequency of the periodic waveform can be between 30 Hz and 60 Hz, for example, 40-50 Hz. In some implementations, the periodic waveform can be a sine wave. In some implementations, the periodic waveform can include a series of square pulses. In some implementations, the periodic waveform can include a repeated series of waves provided to the piezoelectric element 1114, where the waves have a voltage that varies over time according to a function V=V(t) and where, unlike a sine wave, the second derivative of V divided by V (i.e., V”(t) / V(t)) is not equal to one but where, unlike a square wave, V(t) does not include discontinuities, at which the first derivative of V(t) approaches infinity. When comparing two waveforms having an identical frequency and an identical peak-to-peak amplitude, a first waveform in the form of a sine wave may be more energy-efficient, in terms of preserving energy in the battery, for driving the piezoelectric element than a second waveform in the form of a series of square pulses. More generally, a first waveform Vi(t) may be more energy-efficient, in terms of draining energy from the battery, for driving the piezoelectric element to pump a certain volume of fluid than a second waveform V2(t) when the maximum of V”i(t) / Vi(t) is less than the maximum of V”2(t) / V2(t).

[0111] In some implementations, a user or patient may be able to control the actions of the inflatable device in a variety of ways. For example, a user or patient may be able to use the external control device to cause the inflatable member to assume its inflated configuration or assume its deflated configuration. As described in more detail below7, the user or patient may be able to control the inflatable device or cause the inflatable device to behave in a variety of different w ays.

[0112] InflateAtty Docket No. 0073-688W01

[0113] In some implementations, the user or patient can inflate the inflatable device to a user-selected pressure value with one single action or a single selection. For example, in some implementations, the user may be able to pre-select a desired amount of pressure for the inflatable member to assume and then with a single action or selection (for example, using the external controller) the user may cause the inflatable member to be inflated to the desired amount of pressure. In other words, in some implementations, the user may provide a first input to the external controller to set the desired pressure and then provide a second input to the external controller to start or begin the process to inflate the inflatable member to the desired inflation pressure.

[0114] In some implementations, this feature will provide the user the ability to transfer fluid into the inflatable member of the inflatable device on command. Selecting / activating this feature will cause the inflatable device to initiate transfer of fluid into the inflatable member. Additionally, this feature may cause the inflatable device to read a targeted / selected inflation setting (such as the desired amount of pressure) and use this setting to stop the transfer of fluid into the inflatable member when it is reached.

[0115] In some implementations, a maximum pressure to which the inflatable member may be allowed to reach will cap or limit what the user may inflate the inflatable member to. This maximum pressure may be due to device performance limitations (i.e. the inflatable member can only produce so much pressure), device safety limitations (to prevent damage to inflatable device), patient safety limitations (prevent harm to the patient), or desired therapeutic outcomes (maximum or desired inflation level may vary over time) and could be programmable and adjustable by a user or otherwise stored in the inflatable device. In some implementations, this is a pressure maximum, but could be other quantifiable measurements, such as a maximum volume of fluid transfer or a maximum time spent transferring fluid.

[0116] In some implementations, the way the amount of pressure (or amount of inflation of the inflatable member) is display ed to a user may also be different than the actual unit of measure being used to control inflation. For example, while the maximum inflation may be set based on pressure, the interface the user interacts with may be in a percentage scale. In this example, the maximum allowable pressure the inflatable member of the inflatable device is allowed to achieve may be correlated to 100% on the percentage scale displayed to the user. The user may have the ability to inflate the inflatable member of the inflatable device to any level below this preset maximum, based on preference or desired outcome. In other implementations, the maximum allowableAtty Docket No. 0073-688W01 pressure the inflatable member of the inflatable device is allowed to achieve may be correlated to a unitless value, such as a scale of 1-10.

[0117] In some implementations, the external controller may display a variety of different graphical interfaces to the user to allow the user to select or set the desired inflation level. For example, the external controller may display a slider bar, a wheel picker, preset levels associated with quick access buttons which may be programmable and selected by the user, or up and down arrows that can incrementally control the desired inflation level.

[0118] The user may command the inflatable member to assume its inflated state or configuration using a one-step process or multi-step process. In a one-step process, the selecting of the inflation level would also initiate the inflation of the inflatable member. The way in which the user interacts with the device to select the desired inflation pressure or level could also serve as confirmation that both the selected inflation level is the desired level and that that user intends to initiate an inflation of the inflatable member of the inflatable device. In some implementations, the user may hold the selection for inflation level for a given amount of time (such as a few seconds) before it is registered as the selected inflation level target and that the user intends to initiate an inflation of the inflatable member.

[0119] In a multi-step process, selection of the desired inflation level by the user could be followed by a secondary command. For example, the secondary command could be the “start” command, which is described in more detail below. In this two- step process example, the secondary command of “start” would serve as a confirmation that both that targeted inflation limit is correct and that user intends to inflate the inflatable member.

[0120] In some implementations, once inflation has begun, the user will not need to further interact with the inflatable device or the external controller. The inflatable member will achieve the targeted inflated state with no further action required of the user. In other implementations, the user may more actively control the inflation of the device, such as telling it when to stop (see the “stop / pause” as described in more detail below), making minor inflation level adjustments (such as using up or down arrows on a graphical user interface of the external controller) that command a small amount of fluid to move into or out of the inflatable member, or continuously commanding the inflatable member to inflate (for example, the user would depress and hold a button on the external controllerAtty Docket No. 0073-688W01 for inflation to continue and removal or ceasing of the hold (ceasing the holding of the button) will cease inflation and cause the inflatable member to stop inflating).

[0121] Deflate

[0122] In some implementations, the user or patient can deflate the inflatable device to a user-selected pressure value with one single action or a single selection. For example, in some implementations, the user may be able to pre-select a desired amount of pressure for the inflatable member to assume and then with a single action or selection (for example, using the external controller) the user may cause the inflatable member to be deflated to the desired amount of pressure.

[0123] In some implementations, this feature will provide the user the ability to transfer fluid out of the inflatable member of the inflatable device on command. Selecting / activating this feature will cause the inflatable device to initiate transfer of fluid out of the inflatable member and into the reservoir. Additionally, this feature may cause the inflatable device to read a targeted / s elected deflation setting (such as the desired amount of pressure) and use this setting to stop the transfer of fluid out of the inflatable member when it is reached.

[0124] In some implementations, a minimum pressure to which the inflatable member may be allowed to reach will cap or limit what the user may deflate the inflatable member to. This minimum pressure may be due to device performance limitations (i.e. the inflatable member can only alleviate so much pressure), device safety limitations (to prevent damage to inflatable device), patient safety limitations (prevent harm to the patient), or desired therapeutic outcomes (minimum or desired inflation level may vary' over time) and could be programmable and adjustable by a user or otherwise stored in the inflatable device. In some implementations, this is a pressure minimum, but could be other quantifiable measurements, such as a minimum volume of fluid transfer or a minimum time spent transferring fluid.

[0125] In some implementations, the way the amount of pressure (or amount of deflation of the inflatable member) is displayed to a user may also be different than the actual unit of measure being used to control deflation. For example, while the maximum deflation may be set based on pressure, the interface the user interacts with may be in a percentage scale. In this example, the minimum allowable pressure the inflatable member of the inflatable device is allowed to achieve may be correlated to 0% on the percentage scale displayed to the user. The user may have the ability to deflate the inflatable member of the inflatable device to any level above this preset minimum, basedAtty Docket No. 0073-688W01 on preference or desired outcome. In other implementations, the minimum allowable pressure the inflatable member of the inflatable device is allowed to achieve may be correlated to a unitless value, such as a scale of 1-10.

[0126] In some implementations, the external controller may display a variety of different graphical interfaces to the user to allow the user to select or set the desired deflation level. For example, the external controller may display a slider bar, a wheel picker, preset levels associated with quick access buttons which may be programmable and selected by the user, or up and down arrows that can incrementally control the desired deflation level.

[0127] The user may command the inflatable member to assume its deflated state or configuration using a one-step process or multi-step process. In a one-step process, the selecting of the deflation level would also initiate the deflation of the inflatable member. The way in which the user interacts with the device to select the desired deflation pressure or level could also serve as confirmation that both the selected deflation level is the desired level and that that user intends to initiate a deflation of the inflatable member of the inflatable device. In some implementations, the user may hold the selection for deflation level for a given amount of time (such as a few seconds) before it is registered as the selected deflation level target and that the user intends to initiate a deflation of the inflatable member.

[0128] In a multi-step process, selection of the desired deflation level by the user could be followed by a secondary command. For example, the secondary command could be the "start" command, which is described in more detail below. In this two- step process example, the secondary command of ‘‘start'’ would serve as a confirmation that both that targeted deflation limit is correct and that user intends to deflate the inflatable member.

[0129] In some implementations, once deflation has begun, the user will not need to further interact with the inflatable device or the external controller. The inflatable member will achieve the targeted deflated state with no further action required of the user. In other implementations, the user may more actively control the deflation of the device, such as telling it when to stop (see the “stop / pause” as described in more detail below), making minor deflation level adjustments (such as using up or down arrows on a graphical user interface of the external controller) that command a small amount of fluid to move into or out of the inflatable member, or continuously commanding the inflatable member to deflate (for example, the user would depress and hold a button on the externalAtty Docket No. 0073-688W01 controller for deflation to continue and removal or ceasing of the hold (ceasing the holding of the button) will cease deflation and cause the inflatable member to stop deflating).

[0130] Start (or Initiate)

[0131] In some implementations, the user or patient can start an active inflation or deflation of the inflatable member. This feature will provide the user or patient a two- step confirmation (as described in more detail above) of the user’s desire to execute the command given (such as inflate or deflate) in an implementation where changing the state of the device is a multi-step process. In some implementations, an inflation level may be set and if the inflation level is incorrectly selected, the user may change the inflation level to their desired selection. Then the start (or initiate command) may serve as both a confirmation that the selected level (inflation or deflation) is correct and that the change of state of the inflation member is indeed desired by the user to prevent inadvertent or accidental commands being executed.

[0132] In some implementations, this feature may allow the user to toggle the inflatable device between states (for example, between an inflated state or configuration and a deflated state of configuration). Activation of this feature would include first determining what state the inflatable device is in (inflated or deflated) and then cause the device to transfer fluid within the system such that the inflatable member assumes the other state or configuration (deflated or inflated). In some implementations, this may further include determining a defined state value to determine what state the inflatable device is in (for example, if the pressure of the inflatable member is below 2 pounds per square inch (psi) it would be determined that the inflatable member is in the deflated state or configuration). And then determining a value for the other state (for example, 18 psi for the inflated state) and then causing the inflation device to transition to that defined value state.

[0133] In some implementations, the start feature could also be used in scenarios where the transition between states or configurations is interrupted prematurely. For example, in a system driven by pressure, a pressure spike may cause the transition to stop prematurely before truly reaching the desired state or before reaching the desired pressure. The start feature could be activated to re-initiate the transition that was prematurely interrupted.

[0134] Stop / Pause / AbortAtty Docket No. 0073-688W01

[0135] In some implementations, the user can stop or pause an active inflation or deflation. This stop / pause / abort feature may provide the user the ability to interrupt the active inflation or active deflation of the inflatable device. In some implementations, this feature may only be available to the user when the inflatable device is in a transitioning state or mode (such as during an inflation or deflation of the inflatable member).

[0136] In some implementations, the stop / pause / abort feature will interrupt the inflation or deflation, but in addition could have secondary features tied to each. For example, the pause feature could simply stop the inflation or deflation of the inflatable device and if the user utilizes the start feature, the inflatable device would simply resume whatever transition was occurring (for example, if the inflatable device was paused during inflation, activating the start feature would resume the inflation of the inflatable device). The stop feature could be utilized to require the user to decide what they desire to do after initiating the stop feature (for example, the user would need to explicitly decide whether they want to inflate or deflate to exit this stop feature). In some implementations, the abort feature would not only cease whatever feature was being utilized but immediately initiate the deflate feature or function to return the inflatable member to a deflated state.

[0137] MRI mode

[0138] In some implementations, the user can put the system into a magnetic resonance imaging (MRI) safe state. The MRI mode or feature will provide the user the ability to temporarily place the inflatable device into a mode that allows the patient to receive a diagnostic intervention such as an MRI without causing damage to the inflatable device or harm to the patient.

[0139] In some implementations, the inflatable device may also generate a notification that will communicate that the inflatable device is MRI safe (and if conditional, under what conditions) and in a safe mode to receive an MRI. This notification could be shown displayed to medical staff, such as the MRI technician, to confirm that the inflatable device they have is both safe for MRI and in a safe state to receive an MRI. Once the MRI (or other medical treatment) is complete, the user can return the inflatable device from the MRI safe mode to a therapeutic or normal functional mode.

[0140] In some implementations, during the time the MRI mode feature is enabled, some or all functions of the inflatable device may be disabled, thus placing it in a limited to a non-functional state in terms of therapy delivery, until the MRI modeAtty Docket No. 0073-688W01 feature is disabled. The notification that communicates that the device is in MRI mode could be displayed to the user such (and that the inflatable device is not fully functional) so that the user can decern that the inflatable device is in MRI safe mode and in order to restore therapy the user needs to take the inflatable device out of MRI safe mode.

[0141] Start Patient Connection

[0142] In some implementations, after a patient application on the external control device has been setup, the patient can connect to their inflatable device. In some implementations, this feature would allow the user to control the inflatable device or to view a status of the inflatable device. This connection may occur automatically upon launching the application (such as launching or starting the application on the external control device) or may require that the patient trigger a connection once the application is open. In some implementations, this connection will not require that the patient first select the inflatable device that they want to connect to, as the external controller will be bonded, tied or otherwise connected to the inflatable device.

[0143] Replace Patient Application

[0144] In some implementations, the patient can setup a new mobile application to replace an existing patient application. For example, this feature will provide the user the ability to replace the patient application on the patient’s controller (the external controller). This may be needed for a variety of reasons such as the patient receives a new external controller (such as a new phone), the controller is lost (this allows for the application to be loaded onto another controller or device), if the application needed to be uninstalled and then reinstalled, or if there is an update to the application that first requires removal of the existing application.

[0145] Application Authentication

[0146] In some implementations, the user can configure application-level authentication (such as biometrics, a personal identification number (PIN), or another method of authentication) to prevent unwanted access to the patient application. This authentication feature will allow the user to limit access to the patient application by requiring authentication of the user prior to opening or prior to using the application to interrogate or control the inflatable device. In some implementations, this would be an application-level authentication, meaning that an additional authentication would be required for use of the specific application in order to interact with the inflatable device, not just an authentication at the device (external controller) level. This authenticationAtty Docket No. 0073-688W01 could take the form of a PIN that the user would need to enter, or biometric authentication such as fingerprint, face / iris scan, or voice, or another method of authentication.

[0147] Cycling Prompts

[0148] In some implementations, the patient receives prompts to perform activities per a configured protocol (such as a protocol provided by a physician to maintain or use the device according to a therapeutic plan or outline). In some implementations, this feature will generate prompts to the user to remind them to cycle or use their device as prescribed by their physician. Additionally, it could communicate to the patient how they are tracking to (or sticking to) that prescribed protocol by communicating if they currently are within the parameters prescribed to them by their physician or not. This could take the form of a message to the user displayed on the external controller. The external controller could display items in a graphical manner to indicate if the patient has placed their device into the window of parameters prescribed by the physician, how much time is left in their cycling or other use regiment, the status of where they are in their cycling or use regiment, in order to help drive further optimal compliance by the patient. This feature could also contain programmable aspects, such as (A) turn on / off notifications (the user could enable or disable notifications being sent to remind them to cycle or use their inflatable device), (B) set notification time (the user could set a time to receive the notification to cycle or otherwise use their inflatable device, for example, if it best suits the patient to cycle or use their inflatable device in the morning, they could select the prompt to appear in the morning to remind them), (C) turn on / off auto cycling (the user could also enable the inflatable device to automatically cycle, or inflate and then deflate, for them and if desired also provide a notification to the user that the inflatable device is about to auto cycle), and (D) set auto-cycling time (the user could set a time for the auto cycling to occur, for example if the user knows a good time for this to occur is in the evening before bed they could select 10 pm for the autocycling to occur).

[0149] Patient Application Demo Mode

[0150] In some implementations, the patient can download and use the patient application in a demo mode that allow s them to leam and experience the inflatable device or the system of the inflatable device. This feature may allow7the user to navigate through the function or functions of the inflatable device in a demo mode setting, in order to become familiar with the various features of the inflatable device and how to use them. In some implementations, this could take the form of a walk-through demo where theAtty Docket No. 0073-688W01 patient could experience what it is like to utilize the inflatable device prior to implant, or could provide a means to help navigate how to use the inflatable device once implanted. It could provide a step-by-step graphical navigation on how to perform various operations of the inflatable device. This could be called up by the user as needed for navigating how to perform a specific operation, or could be provided in manner that is more of a tutorial covering some or all aspects of the inflatable device.

[0151] In some implementations, this feature would be part of the patient application stored or used on the external control device. If the inflatable device we not implanted or were placed in a deactivated state, the demo mode would not allow one to functionally control the inflatable device and would serve as simply a tutorial with no functional behavior. If the inflatable device were implanted and activated, it could additionally allow one to functionally control the inflatable device as the user utilized the demo mode. For example, it could overlay a graphical user interface and when it indicates to select inflate and when the user selects inflate on the application the inflatable device would respond by inflating the inflatable member.

[0152] Restricted Data Mode (Opt Out)

[0153] In some implementations, the patient can request, and the physician can enable, a mode that restricts physician access to health trend data. This feature will provide the patient the ability to restrict sharing of certain data with the physician or other clinician. This data is generically referred to as health trend data but can include data that may convey how the inflatable device is being used by the patient. For example, this data could include information such as how often the inflatable device is used and on what days, for how long, or what pressures were utilized. It could also include data such as compliance to their cycling or other use protocol or how often they are recharging their battery. When this feature is enabled, it will prevent certain data from being accessible by the physician (such as by a second external controller such as a physician controller when the controller connects to the inflatable device). In some implementations, data that is needed to allow prescription of therapy, such as programming a maximum pressure the inflatable member is allowed to reach, or setting of an auto-deflation time would not be restricted (or otherwise kept from the physician).

[0154] Inflation Delay

[0155] In some implementations, the user can enable an inflation delay and configure the delay duration. This inflation delay feature will provide the user the ability' to delay the start of the inflation of the inflatable member of the inflatable device. InAtty Docket No. 0073-688W01 some implementations, the user may set an amount of time to delay initiation of inflation from the time an “inflate" command is given. For example, if the patient were to set the inflation delay to 5 minutes, when this was enabled and the user initiated an inflation cycle, actual transfer of fluid into the inflatable member would begin 5 minutes after selecting inflate. In some implementations, the inflation delay feature would allow the user to decouple (or otherwise separate in term so timing) the act of controlling the inflatable device from the act of the inflatable device performing its desired function, serving to minimize the interruption caused by needing to control or interact with the inflation device.

[0156] Auto-Deflate - Configurable Duration

[0157] In some implementations, the inflatable device will automatically deflate after a user-configurable duration (or user set time period). This feature will provide the user the ability to set the inflatable device into an auto-deflate mode and could replace or augment the need for the user to use the deflate feature. In some implementations, the patient can configure this feature to have the inflatable device transition from an inflated state or configuration to a deflated state or configuration automatically. In some implementations, this feature would trigger after a set period of time elapses (in other words, the inflatable device will transition from an inflated state or configuration to a deflated state or configuration after a set period of time elapses). In some implementations, the period of time would be configurable (or selectable) by the user and could also be enabled or disabled as desired, that is could be used in some situations and not others. This period of time could be based on (or start) when the inflation was initiated, when the inflation was completed, or some other point of reference.

[0158] In some implementations, the transition from an inflated state or configuration to a deflated state or configuration could be triggered (or otherwise activated) by feedback from other sensors within the inflatable device, such as a pressure sensor or accelerometer IN such implementations, the sensors could be used to detect states that would signal the patient is done needing the inflatable device to remain inflated (for example, the sensors could detect a reduced amount of motion or a lack of pressure spikes) and initiate the auto-deflation feature. In some implementations, this feature could be combined with the timing, such that the reduced motion or pressure spikes must be maintained for a period of time before initiating the auto-deflation feature.

[0159] In some implementations, the auto-deflate feature could return the inflatable member to a state where no pressure or fluid remains within the inflatableAtty Docket No. 0073-688W01 member or to a pressure or fluid level lower than a current pressure or fluid level. Additionally, the pressure or fluid level to which the auto-deflate feature will transition the inflatable member could be configurable (or selectable) by the user.

[0160] Scheduled Inflations

[0161] In some implementations, the user can configure or set scheduled inflations (for example, nocturnal tumescence). This feature will allow the user to configure the inflatable device so that inflations could be scheduled. For example, during the one time period, the user could configure the inflatable device to automatically inflate at a time that is convenient for the user and would not require the user to do anything themselves or remember the need use (or to cycle) the inflatable device themselves. As another example, this could be scheduled to happen while the user or patient sleeps and w ould mimic nocturnal erections that erectile functional men have. In some implementations, the user may select a time of day for the inflation to occur. In other implementations, a sensor of the inflatable device, such as an accelerometer, may be used to determine if the patient is asleep and to trigger the scheduled inflation of the inflatable member.

[0162] FIG. 11 is a flow chart of a method 900 of using or controlling a medical device according to an implementation. At 910 a user may provide a first input to the medical device, for example via the external controller. In some implementations, the first input is associated with a desired pressure for the inflatable member of the medical device. In other implementations, the first input is associated with something else, such as a desired time delay.

[0163] At 920 a user may provide a second input to the medical device, for example, via the external controller. In some implementations, receipt of the second input causes the inflatable member of the medical device to transition. For example, receipt of the second input may cause the inflatable member of the medical device to transition from a deflated configuration to an inflated configuration or from an inflated configuration to a deflated configuration.

[0164] At 930 a user may provide a third input to the medial device, for example, via the external controller. In some implementations, the third input may be associated with a stop / pause / abort which would cause the medical device to cease or stop any currently activated transition. In other implementations, the third input could be associated with a different command or setting.Atty Docket No. 0073-688W01

[0165] Portions of the above example aspects, features, and corresponding detailed description are presented in terms of functions of software, or algorithms and symbolic representations of operation on data bits within a computer memory. These descriptions and representations are the ones by which those of ordinary skill in the art effectively convey the substance of their work to others of ordinary skill in the art. An algorithm, as the term is used here, and as it is used generally, is conceived to be a self- consistent sequence of steps leading to a desired result. The steps are those requiring physical manipulations of physical quantities. Usually, though not necessarily, these quantities take the form of optical, electrical, or magnetic signals capable of being stored, transferred, combined, compared, and otherw ise manipulated. It has proven convenient at times, principally for reasons of common usage, to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like.

[0166] In the above illustrative aspects and features, reference to acts and symbolic representations of operations (e g., in the form of flowcharts) that may be implemented as program modules or functional processes include routines, programs, objects, components, data structures, etc., that perform particular tasks or implement particular abstract data types and may be described and / or implemented using existing hardware at existing structural elements. Such existing hardware may include one or more Central Processing Units (CPUs), digital signal processors (DSPs), applicationspecific-integrated-circuits. field programmable gate arrays (FPGAs) computers or the like.

[0167] It should be bome in mind, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless specifically stated otherwise, or as is apparent from the discussion, terms such as processing or computing or calculating or determining of displaying or the like, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical, electronic quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.

[0168] Note also that the software implemented features or aspects of the example features or aspects are typically encoded on some form of non-transitory program storage medium or implemented over some type of transmission medium. The program storage medium may be magnetic (e.g., a floppy disk or a hard drive) or opticalAtty Docket No. 0073-688W01(e.g., a compact disk read only memory. or CD ROM), and may be read only or random access. Similarly, the transmission medium may be twisted wire pairs, coaxial cable, optical fiber, or some other suitable transmission medium known to the art. The example aspects are not limited by these aspects of any given implementation.

[0169] While certain features of the described implementations have been illustrated as described herein, many modifications, substitutions, changes and equivalents will now occur to those skilled in the art. It is, therefore, to be understood that the will and in and in appended claims are intended to cover all such modifications and changes as fall within the scope of the embodiments.

Claims

Atty Docket No. 0073-688W01WHAT IS CLAIMED IS:

1. A medical device, comprising: a bodily implant having a communications module and an inflatable member, the inflatable member of the bodily implant being configured to be disposed in an inflated configuration and in a deflated configuration; and an external controller having a communications module configured to communicate with the communications module of the bodily implant, the external controller configured to receive a first input associated with a desired pressure for the inflatable member, the external controller configured to receive a second input different than the first input, the bodily implant being configured to cause the inflatable member to be disposed at the desired pressure in response to the first input and the second input being received by the external controller.

2. The medical device of claim 1, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in the inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member.

3. The medical device of any of claims 1-2, wherein the desired pressure is associated with the inflated configuration of the inflatable member.

4. The medical device of any of claims 1-2, wherein the desired pressure is associated with the inflated configuration, the bodily implant is configured to cause the inflatable member to transition from the deflated configuration of the inflatable member to the inflated configuration of the inflatable member such that the inflatable member is disposed at the desired pressure.

5. The medical device of any of claims 1-2, wherein the desired pressure is associated with the deflated configuration of the inflatable member.

6. The medical device of any of claims 1-2, wherein the desired pressure is associated with the deflated configuration, the bodily implant is configured to cause theAtty Docket No. 0073-688W01 inflatable member to transition from the inflated configuration of the inflatable member to the deflated configuration of the inflatable member such that the inflatable member is disposed at the desired pressure.

7. The medical device of any of claims 1-2, wherein the external controller is configured to receive a third input different than the first input and different than the second input, the bodily implant being configured to stop a transition of the inflatable member in response to the external controller receiving the third input.

8. The medical device of any of claims 1-2, wherein the external controller is configured to receive a third input different than the first input and different than the second input, the bodily implant being configured to stop a transition of the inflatable member from the inflated configuration of the inflatable member to the deflated configuration of the inflatable member in response to the external controller receiving the third input.

9. The medical device of any of claims 1-2, wherein the external controller is configured to receive a third input different than the first input and different than the second input, the bodily implant being configured to stop a transition of the inflatable member from the deflated configuration of the inflatable member to the inflated configuration of the inflatable member in response to the external controller receiving the third input.

10. The medical device of any of claims 1-9, wherein the bodily implant is a penile implant.

11. The medical device of any of claims 1-9, wherein the bodily implant is an artificial sphincter.

12. A medical device, comprising: a bodily implant having a communications module and an inflatable member, the inflatable member of the bodily implant being configured to be disposed in an inflated configuration and in a deflated configuration; andAtty Docket No. 0073-688W01 an external controller having a communications module configured to communicate with the communications module of the bodily implant, the external controller configured to receive a first input associated with a desired time delay, the external controller configured to receive a second input different than the first input, the bodily implant being configured to cause the inflatable member to transition from the deflated configuration of the inflatable member to the inflated configuration of the inflatable member in response to the second input being received by the external controller and after the desired time delay has elapsed since the second input is received by the external controller.

13. The medical device of claim 12, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in the inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member.

14. The medical device of any of claims 12-13, wherein the external controller is configured to receive a third input different than the first input and different than the second input, the bodily implant being configured to stop the transition of the inflatable member from the deflated configuration of the inflatable member to the inflated configuration of the inflatable member in response to the external controller receiving the third input.

15. The medical device of any of claims 12-14, wherein the bodily implant is a penile implant.

16. A medical device, comprising: a bodily implant having a communications module and an inflatable member, the inflatable member of the bodily implant being configured to be disposed in an inflated configuration and in a deflated configuration; and an external controller having a communications module configured to communicate with the communications module of the bodily implant, the external controller configured to receive a first input associated with a desired pressure for the inflatable member, the external controller configured to receive a second input different than the first input,Atty Docket No. 0073-688W01 the bodily implant being configured to cause the inflatable member to be disposed at the desired pressure in response to the first input and the second input being received by the external controller.

17. The medical device of claim 16, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in the inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member.

18. The medical device of claim 16, wherein the desired pressure is associated with the inflated configuration of the inflatable member.

19. The medical device of claim 16, wherein the desired pressure is associated with the inflated configuration, the bodily implant is configured to cause the inflatable member to transition from the deflated configuration of the inflatable member to the inflated configuration of the inflatable member such that the inflatable member is disposed at the desired pressure.

20. The medical device of claim 16, wherein the desired pressure is associated with the deflated configuration of the inflatable member.

21. The medical device of claim 16, wherein the desired pressure is associated with the deflated configuration, the bodily implant is configured to cause the inflatable member to transition from the inflated configuration of the inflatable member to the deflated configuration of the inflatable member such that the inflatable member is disposed at the desired pressure.

22. The medical device of claim 16, wherein the external controller is configured to receive a third input different than the first input and different than the second input, the bodily implant being configured to stop a transition of the inflatable member in response to the external controller receiving the third input.

23. The medical device of claim 16, wherein the external controller is configured to receive a third input different than the first input and different than theAtty Docket No. 0073-688W01 second input, the bodily implant being configured to stop a transition of the inflatable member from the inflated configuration of the inflatable member to the deflated configuration of the inflatable member in response to the external controller receiving the third input.

24. The medical device of claim 16, wherein the external controller is configured to receive a third input different than the first input and different than the second input, the bodily implant being configured to stop a transition of the inflatable member from the deflated configuration of the inflatable member to the inflated configuration of the inflatable member in response to the external controller receiving the third input.

25. The medical device of claim 16, wherein the bodily implant is a penile implant.

26. The medical device of claim 16, wherein the bodily implant is an artificial sphincter.

27. A medical device, comprising: a bodily implant having a communications module and an inflatable member, the inflatable member of the bodily implant being configured to be disposed in an inflated configuration and in a deflated configuration; and an external controller having a communications module configured to communicate with the communications module of the bodily implant, the external controller configured to receive a first input associated with a desired time delay, the external controller configured to receive a second input different than the first input, the bodily implant being configured to cause the inflatable member to transition from the deflated configuration of the inflatable member to the inflated configuration of the inflatable member in response to the second input being received by the external controller and after the desired time delay has elapsed since the second input is received by the external controller.

28. The medical device of claim 27, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatableAtty Docket No. 0073-688W01 member in the inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member.

29. The medical device of claim 27, wherein the external controller is configured to receive a third input different than the first input and different than the second input, the bodily implant being configured to stop the transition of the inflatable member from the deflated configuration of the inflatable member to the inflated configuration of the inflatable member in response to the external controller receiving the third input.

30. The medical device of claim 27, wherein the bodily implant is a penile implant.

31. A method of controlling a medical device, comprising: providing a first input to an external controller, the first input being associated with an amount of pressure; providing a second input on the external controller, the second input being different than the first input, to cause an inflatable member of a bodily implant to transition from a deflated configuration to an inflated configuration.

32. The method of claim 31 , further comprising: providing a third input to the external controller, the third input being different than the first input and different than the second input.

33. The method of claim 31 , further comprising: providing a third input to the external controller, the third input being different than the first input and different than the second input, to cause the bodily implant to stop a transition of the inflatable member from the deflated configuration to the inflated configuration.

34. The method of claim 31, wherein the bodily implant is a penile implant.

35. The method of claim 31, wherein the bodily implant is an artificial sphincter.

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