PUMP ASSEMBLY FOR IMPLANTABLE INFLATABLE DEVICE - Patent application

Abstract

The implantable fluid-actuated device may include a fluid reservoir configured to hold a fluid, an inflatable member, and a pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member. The pump assembly may include one or more fluid pumps and one or more valves. One or more sensing devices may be disposed within a fluid path of the fluid-actuated device. An electronic control system may control operation of the pump assembly based on fluid pressure and / or fluid flow measurements received from the one or more sensing devices. The pump assembly may include a piezoelectric pump. The one or more sensing devices may include one or more pressure transducers disposed within the fluid path, one or more strain gauges that measure deflection of a piezoelectric element, voltage inputs / outputs at the one or more piezoelectric elements, and other types of sensing devices.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of and claims priority to U.S. Provisional Patent Application No. 17 / 655,937, entitled "PUMP ASSEMBLY FOR AN IMPLANTABLE INFLATABLE DEVICE," filed on March 22, 2022, which claims priority to U.S. Provisional Patent Application No. 63 / 200,737, entitled "PUMP ASSEMBLY FOR AN IMPLANTABLE INFLATABLE DEVICE," filed on March 25, 2021, the disclosures of which are incorporated herein by reference in their entireties.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 200,737, filed March 25, 2021, the disclosure of which is incorporated by reference in its entirety.

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

[0004] Actively implantable fluid-actuated inflatable devices often include one or more pumps that regulate fluid flow between different portions of the implantable device to allow inflation and deflation of one or more fluid-filled implant components of the implantable device. One or more valves may be disposed within the fluid passages of the device to direct and control fluid flow to achieve inflation, deflation, pressurization, depressurization, activation, deactivation, etc. of different fluid-filled implant components of the device. In some implantable fluid-actuated inflatable devices, sensors may be used to monitor fluid pressure and / or fluid volume and / or fluid flow rate within the fluid passages of the device. Accurate monitoring of conditions within the device, including pressure monitoring and flow monitoring, may allow for improved control of device operation, improved diagnostics, and improved device effectiveness. Summary of the Invention [Means for solving the problem]

[0005] According to one aspect, an implantable fluid-actuated inflatable device includes a fluid reservoir, an inflatable member, and a pump and valve assembly configured to transfer fluid between the fluid reservoir and the inflatable member. The pump assembly includes a housing, at least one valve and at least one pump disposed in a fluid passage formed in the housing, a manifold including a first fluid port in fluid communication with the fluid reservoir and a second fluid port in fluid communication with the inflatable member. The device further includes an electronic control system that controls operation of the pump and valve assembly, and at least one pressure sensing device in communication with the electronic control system.

[0006] In some implementations, the at least one valve and the at least one pump can include a first pump and a first valve disposed in the first fluid passage and in fluid communication with the first fluid port, and a second pump and a second valve disposed in the second fluid passage and in fluid communication with the second fluid port. The at least one pressure sensing device can include a first pressure sensing device disposed in the first fluid passage and configured to measure a pressure of the fluid flowing through the first fluid port and transmit the measured pressure to the electronic control system, and a second pressure sensing device disposed in the second fluid passage and configured to measure a pressure of the fluid flowing through the second fluid port and transmit the measured pressure to the electronic control system.

[0007] In some implementations, the at least one valve and the at least one pump include a dual piezoelectric pump manifold configuration including a first piezoelectric pump, a second piezoelectric pump, and a fluid channel that allows fluid communication between the first and second piezoelectric pumps. The first piezoelectric pump can include a first chamber, a first piezoelectric diaphragm disposed along an edge portion of the first chamber, a first check valve at an inlet end of the first chamber, and a second check valve at an outlet end of the first chamber that selectively allows fluid communication between the first chamber and the fluid channel. The second piezoelectric pump can include a second chamber, a second piezoelectric diaphragm disposed along an edge portion of the second chamber, a first check valve at an inlet end of the second chamber, and a second check valve at an outlet end of the second chamber that selectively allows fluid communication between the fluid channel and the second chamber. In some implementations, a pumping cycle of the dual piezoelectric pump manifold configuration includes a first stage including a supply stroke of a first piezoelectric diaphragm in coordination with a pressure stroke of a second piezoelectric diaphragm, and a second stage including a pressure stroke of the first piezoelectric diaphragm in coordination with a supply stroke of the second piezoelectric diaphragm, in the first stage, fluid is drawn into a first chamber through a first check valve of the first piezoelectric pump and fluid is exhausted from a second chamber through a second check valve of the second piezoelectric pump, and in the second stage, fluid is exhausted from the first chamber into a fluid channel through a second check valve of the first piezoelectric pump and fluid is drawn from the fluid channel into the second chamber through a first check valve of the second piezoelectric pump.

[0008] In some implementations, the housing of the manifold is formed of injection molded metal material, machined metal material, or the like, and the at least one pump and the at least one valve are disposed within a sealed fluid passage defined in the injection molded metal material such that the manifold is a sealed manifold.

[0009] In some implementations, the pump assembly includes a pump assembly housing, the manifold and the electronic control system are housed within the pump assembly housing, the manifold can be a sealed manifold, and the components of the electronic control system within the pump assembly housing are isolated from the fluid flowing through the sealed manifold.

[0010] In some implementations, the at least one pressure sensing device includes a first pressure sensing device disposed proximate to a fluid port of the reservoir and a second pressure sensing device disposed proximate to a fluid port of the inflatable member. The first pressure sensing device can include a first diaphragm disposed in a fluid passage proximate to the reservoir facing the reservoir and at least one first strain gauge attached to the first diaphragm and configured to measure deflection of the first diaphragm and transmit the measured deflection to the electronic control system. The second pressure sensing device can include a second diaphragm disposed in a fluid passage proximate to the fluid port of the inflatable member facing the inflatable member and at least one second strain gauge attached to the second diaphragm and configured to measure deflection of the second diaphragm and transmit the measured deflection to the electronic control system.

[0011] In some implementations, the at least one sensing device includes at least one piezoelectric element disposed within a fluid passageway of the implantable fluid-actuated device and configured to sense a fluid pressure level within the fluid passageway based on an input voltage level applied to the piezoelectric element and an output voltage level measured at the piezoelectric element.

[0012] In some implementations, the electronic control system includes a printed circuit board including a processor configured to receive pressure level measurements from at least one sensing device, apply a control algorithm based on the received pressure level measurements, and control operation of the at least one valve and the at least one pump in accordance with the applied control algorithm.

[0013] In some implementations, the implantable fluid-actuated device is an artificial urinary sphincter or an inflatable penile prosthesis.

[0014] In another general aspect, an implantable fluid-actuated inflatable device includes a fluid reservoir, an inflatable member, a pump assembly received within a housing and configured to transfer fluid between the fluid reservoir and the inflatable member, and an electronic control system. The pump assembly can include a manifold and a pump and a valve arrangement housed within the manifold. The electronic control system can be configured to control operation of the pump and the valve arrangement.

[0015] In some implementations, the manifold is a sealed manifold and the electronic control system includes a first portion received within an electronics compartment of the housing isolated from fluid flowing through the manifold. In some implementations, the electronic control system includes a second portion configured to be external to the implantable fluid-actuated inflatable device and in communication with the first portion of the electronic control system, the second portion configured to receive user input and output information to a user.

[0016] In some implementations, the pump and valve arrangement is a dual piezoelectric pump and valve arrangement including a first piezoelectric pump in fluid communication with a second piezoelectric pump through a fluid channel in a manifold or housing. The first piezoelectric pump can include a first chamber, a first piezoelectric element and a diaphragm disposed along an edge portion of the first chamber, a first check valve at an inlet end of the first chamber, and a second check valve at an outlet end of the first chamber that selectively allows fluid communication between the first chamber and the fluid channel. The second piezoelectric pump can include a second chamber, a second piezoelectric element and a diaphragm disposed along an edge portion of the second chamber, a first check valve at an inlet end of the second chamber, and a second check valve at an outlet end of the second chamber that selectively allows fluid communication between the fluid channel and the second chamber. In some implementations, in an inflation mode, the electronic control system is configured to alternately apply voltage inputs to the first and second piezoelectric elements to cause fluid to flow in a first direction from the fluid reservoir toward the inflatable member through the dual piezoelectric pump manifold configuration, and in a deflation mode, the electronic control system is configured to alternately apply voltage inputs to the first and second piezoelectric elements to cause fluid to flow in a second direction from the inflatable member toward the reservoir through the dual piezoelectric pump manifold configuration. [Brief description of the drawings]

[0017] [Figure 1] FIG. 1 is a block diagram of an implantable fluid-actuated inflatable device according to an embodiment. [Figure 2A] 1A-1C illustrate example implantable fluid-actuated inflatable devices according to certain aspects. [Figure 2B] 1A-1C illustrate example implantable fluid-actuated inflatable devices according to certain aspects. [Diagram 3] FIG. 2 is a schematic diagram of a fluid architecture of a pump assembly of an implantable fluid-actuated inflatable device, according to an embodiment. [Figure 4A] FIG. 2 is a perspective view of an example manifold of an example pump assembly, according to certain aspects. [Figure 4B] FIG. 2 is a perspective view of an example manifold of an example pump assembly, according to certain aspects. [Figure 5A] FIG. 2 is a perspective view of an example manifold mounted within an example pump assembly of an implantable fluid-actuated inflatable device, according to certain aspects. [Figure 5B] FIG. 2 is a perspective view of an example manifold mounted within an example pump assembly of an implantable fluid-actuated inflatable device, according to certain aspects. [Figure 6A] 1A-1C are schematic diagrams illustrating the operation of an example piezoelectric pump of an implantable fluid-actuated inflatable device, according to certain aspects. [Figure 6B] 1A-1C are schematic diagrams illustrating the operation of an example piezoelectric pump of an implantable fluid-actuated inflatable device, according to certain aspects. [Figure 6C] 1A-1C are schematic diagrams illustrating the operation of an example piezoelectric pump of an implantable fluid-actuated inflatable device, according to certain aspects. [Figure 7A] 1A-1C are schematic diagrams illustrating the operation of an example dual piezoelectric pump and valve manifold configuration of an implantable fluid-actuated inflatable device, according to certain aspects. [Figure 7B] 1A-1C are schematic diagrams illustrating the operation of an example dual piezoelectric pump and valve manifold configuration of an implantable fluid-actuated inflatable device, according to certain aspects. [Figure 7C] 1A-1C are schematic diagrams illustrating the operation of an example dual piezoelectric pump and valve manifold configuration of an implantable fluid-actuated inflatable device, according to certain aspects. [Figure 8] FIG. 13 is a block diagram of the operation of an example dual piezoelectric pump and valve manifold configuration of an implantable fluid-actuated inflatable device, according to an embodiment. [Figure 9A] 1 is a schematic diagram of an implantable fluid-actuated inflatable device including an in-line pressure sensing device, according to an embodiment. [Figure 9B] 1 is a schematic diagram of an implantable fluid-actuated inflatable device including an in-line pressure sensing device, according to an embodiment. [Figure 10A] 1 is a graph illustrating the effect of changes in atmospheric pressure on the measured pressure within an implantable fluid-actuated inflatable device. [Figure 10B] 1 is a graph illustrating the effect of changes in atmospheric pressure on the measured pressure within an implantable fluid-actuated inflatable device. [Figure 10C] 1 is a graph illustrating the effect of changes in atmospheric pressure on the measured pressure within an implantable fluid-actuated inflatable device. [Figure 11A] 4 is a graph illustrating the effect of impulses in an inflatable member on measured pressure within an implantable fluid-actuated inflatable device. [Figure 11B] 4 is a graph illustrating the effect of impulses in an inflatable member on measured pressure within an implantable fluid-actuated inflatable device. [Figure 11C] 4 is a graph illustrating the effect of impulses in an inflatable member on measured pressure within an implantable fluid-actuated inflatable device. [Figure 11D] 4 is a graph illustrating the effect of impulses in an inflatable member on measured pressure within an implantable fluid-actuated inflatable device. [Figure 12A] 13 is a graph illustrating the effect of an impulse in a reservoir on the measured pressure in an implantable fluid-actuated inflatable device. [Figure 12B] 13 is a graph illustrating the effect of an impulse in a reservoir on the measured pressure in an implantable fluid-actuated inflatable device. [Figure 12C] 13 is a graph illustrating the effect of an impulse in a reservoir on the measured pressure in an implantable fluid-actuated inflatable device. [Figure 12D] 13 is a graph illustrating the effect of an impulse in a reservoir on the measured pressure in an implantable fluid-actuated inflatable device. [Figure 13A] 4 is a graph illustrating the effect of a component failure or blockage in a fluid passage on the measured pressure in an implantable fluid-actuated inflatable device. [Figure 13B] 4 is a graph illustrating the effect of a component failure or blockage in a fluid passage on the measured pressure in an implantable fluid-actuated inflatable device. [Figure 13C] 4 is a graph illustrating the effect of a component failure or blockage in a fluid passage on the measured pressure in an implantable fluid-actuated inflatable device. [Figure 13D]4 is a graph illustrating the effect of a component failure or blockage in a fluid passage on the measured pressure in an implantable fluid-actuated inflatable device. [Figure 14A] FIG. 2 is a top view of an example diaphragm with attached strain gauges that measure the deflection of the diaphragm. [Figure 14B] FIG. 2 is a side view of an example diaphragm with attached strain gauges that measure the deflection of the diaphragm. [Figure 14C] FIG. 2 is a side view of an example diaphragm with attached strain gauges that measure the deflection of the diaphragm. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Detailed implementations are disclosed herein. However, it should be understood that the disclosed implementations are merely examples and can be embodied in various forms. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limitations, but merely as a basis for the claims and as representative basis for teaching those skilled in the art that these implementations can be variously employed in substantially any suitable detailed structure. Moreover, the terms and expressions used herein are not intended to be limiting, but are intended to provide an understandable description of the present disclosure.

[0019] The term "a" as used herein is defined as one or more than one. The term "another" as used herein is defined as at least a second or more. The terms "including" and / or "having" as used herein are defined as comprising (i.e., an open transition). The terms "coupled" or "moveably coupled" as used herein are defined as connected, although not necessarily directly and mechanically.

[0020] In general, the implementation relates to a body implant. Hereinafter, the term patient or user can be used for a person who will benefit from the medical device or method disclosed in this disclosure. For example, a patient can be a person in whose body a medical device or the disclosed method for operating a medical device according to the present disclosure is implanted.

[0021] FIG. 1 is a block diagram of an example implantable fluid-actuated inflatable device 100. The example device 100 shown in FIG. 1 includes a fluid reservoir 102, an inflatable member 104, and a pump assembly 106 configured to transfer fluid between the fluid reservoir 102 and the inflatable member 104. In some implementations, the example device 100 includes a control system 108. In some implementations, the control system 108 is an electronic control system 108. The control system 108 may enable monitoring and / or control of the operation of various components of the pump assembly 106 and / or communication with one or more sensing devices within the implantable fluid-actuated inflatable device 100 and / or communication with one or more external devices. The fluid reservoir 102, the inflatable member 104, and the pump assembly 106 may be implanted within a patient's body. In some implementations, the control system 108 is coupled to or incorporated into the pump assembly 106. In some implementations, at least a portion of the control system 108 is separate or remote from the pump assembly 106. In some implementations, some modules of the control system 108 are coupled to or incorporated into the pump assembly 106 and some modules of the control system 108 are separate from the pump assembly 106. For example, in some implementations, some modules of the control system 108 are included in an external device that communicates with other modules of the control system 108 included within the implantable device 100. In some implementations, the pump assembly 106 is electronically controlled. In some implementations, the pump assembly 106 is manually controlled.

[0022] In some examples, electronic monitoring and control of the fluid-actuated device 100 may allow for improved patient control of the device, improved patient comfort, and improved patient safety. In some examples, electronic monitoring and control of the fluid-actuated device 100 may provide an opportunity for a physician to adjust the operation of the device 100 without further surgical intervention.

[0023] The example implantable fluid-actuated device 100 can represent a number of different types of implantable fluid-actuated devices. For example, the device 100 shown in FIG. 1 can represent an artificial urinary sphincter 100A as shown in FIG. 2A. The artificial urinary sphincter 100A includes a pump assembly 106A. In the example shown in FIG. 2A(1), for example, a control system 108A electronically controls the operation of the pump assembly 106A to enable the transfer of fluid between the reservoir 102A and the inflatable cuff 104A. In the example shown in FIG. 2B, the pump assembly 106A can be manually controlled. A first conduit 103A connects the pump assembly 106A / control system 108A to the reservoir 102A. A second conduit 105A connects the pump assembly 106A / control system 108A to the inflatable cuff 104A. In some examples, the device 100 shown in FIG. 1 can represent an inflatable penile prosthesis 100B as shown in FIG. 2B. The example penile prosthesis 100B includes a pump assembly 106B. In the example shown in FIG. 2B(1), for example, a control system 108B electronically controls the operation of the pump assembly 106A to allow for the transfer of fluid between the fluid reservoir 102B and the inflatable cylinder 104B. In the example shown in FIG. 2B(2), the pump assembly 106B can be manually controlled. A first conduit 103B connects the pump assembly 106B / control system 108B to the reservoir 102B. One or more second conduits 105B connect the pump assembly 106A / control system 108A to the inflatable cylinder 104B. The principles described herein can be applied to these and other types of implantable fluidic devices that rely on pump assemblies for effective operation to allow for the transfer of fluid between different fluid-filled implant components to achieve inflation, deflation, pressurization, depressurization, deactivation, and the like. Example devices 100A, 100B can include electronic control systems 108A, 108B that allow for monitoring and control of pressure and / or fluid flow through the respective devices 100A, 100B. The principles described herein can also be applied to implantable, fluid-actuated devices that are manually controlled.

[0024] As discussed above with respect to FIG. 1, the pump assembly may include one or more pumps and one or more valves disposed in a fluid circuit of the pump assembly that control the transfer of fluid between the fluid reservoir and the inflatable member. In some examples, the pump(s) and / or the valve(s) are electronically controlled. In some examples, the pump(s) and / or the valve(s) are manually controlled. In some examples, the pump assembly includes a fluid manifold having fluid channels formed therein that define the fluid circuit. In examples where the pump assembly is electronically driven and / or controlled, the manifold may be a sealed manifold that may contain and compartmentalize the fluid flow from the electronic components of the pump assembly to prevent leakage and / or gas exchange. In some examples, the pump assembly includes one or more pressure sensing devices in the fluid circuit that allow for relatively accurate monitoring and control of the fluid flow and / or pressure within the fluid circuit and / or the inflatable member. A fluid circuit configured in this manner may facilitate correct inflation, deflation, pressurization, depressurization, activation and deactivation of components of an implantable fluid-operated device to provide patient safety and device efficacy.

[0025] 3 is a schematic diagram of an example fluid architecture of an implantable fluid-actuated device according to an embodiment. The schematic diagram shown in FIG. 3 is just one example arrangement. The fluid architecture of an implantable fluid-actuated device may also include other orientations of fluid channels, valve(s), pressure sensor(s), and other components. A fluid architecture that can accommodate back pressure, pressure surges, and the like, enhances the performance, effectiveness, and efficiency of the fluid-actuated device 100.

[0026] The example fluidic architecture shown in Figure 3 includes channels directing fluid flow between the reservoir 102 and the inflatable member 104. In the example shown in Figure 3, a first valve V1 in a first fluidic channel controls the flow of fluid produced by a first pump device P1 from the inflatable member 104 to the reservoir 102. A second valve V2 in a second fluidic channel controls the flow of fluid produced by a second pump device P2 from the reservoir 102 to the inflatable member 104. In the example shown in Figure 3, a first pressure sensing device S1 senses the fluid pressure in the reservoir 102 and a second pressure sensing device S2 senses the fluid pressure in the inflatable member 104. The first and second pressure sensing devices S1, S2 can enable monitoring of the fluid flow and / or fluid pressure in the fluidic channels. In the arrangement shown in FIG. 3A, either the first pump P1 or the second pump P2 is operated while the other of the first pump P1 or the second pump P2 is in a standby mode, and typically the first and second pumps do not operate simultaneously. For example, operation of the first pump P1 (with the second pump P2 in a standby mode) can enable the deflation of the inflatable member 104, and operation of the second pump P2 (with the first pump P1 in a standby mode) can enable the inflation of the inflatable member 104. The valves V1, V2 can enable selective sealing of the respective fluid channels to maintain a set state of the fluid-actuated device. In some implementations, the valves V1, V2 can facilitate transitions between states (i.e., between an inflated state and a deflated state) of the fluid-actuated device. For example, selective sealing of the respective fluid channels by the valves V1, V2 can maintain an inflated or deflated state of the inflatable member 104. Interaction with valves V1, V2 (and corresponding changes in fluid flow through the fluid architecture of the device) can change the setting of the fluid-actuated device. Valves V1, V2 maintain the setting of the device until a patient indicates a need for a change in the setting and initiates the required change in the setting of the device, resulting in enhanced patient safety and improved effectiveness of the device.

[0027] 4A and 4B are perspective views of an example manifold 400 for use with a pump assembly of an implantable fluid-actuated device. In FIG. 4B, the housing 410 of the example manifold 400 is transparent so that the arrangement of the internal fluid components of the manifold 400 (such as valve(s), pump(s) and sensor(s)) can be seen. FIG. 5A and 5B are perspective views of an example pump assembly 500 including the manifold 400 and an electronic control system 550. In FIG. 5B, a portion of the housing 510 of the pump assembly 500 has been removed so that the internal components of the pump assembly 500 can be seen.

[0028] The example manifold 400 may employ a fluid architecture such as the fluid circuit defined by the schematic diagram shown in Figure 3, or other fluid architectures. The fluid architecture of the manifold 400 may enable controlled transfer and monitoring of fluid between a fluid reservoir 102 and an inflatable member 104 within an implantable, fluid-actuated device (such as the example device 100 shown in Figures 2A and 2B).

[0029] The manifold 400 may include a housing 410. Fluid passages may be defined within the housing 410 within which fluid components are disposed. In some examples, the housing 410 is manufactured from a solid piece of material. In some examples, the housing 410 may be molded, such as by injection molding. In some examples, the housing 410 is formed from a metallic material, such as titanium, steel, or other biocompatible material. As a result, fluid components may be mounted within the fluid passages defined within the housing 410 to seal the fluid passages. The manifold 400 / housing 410 thus manufactured may be sealed such that fluids flowing through the manifold 400 and components received within the manifold 400 are contained within the manifold 400. In situations where one or more of the fluid components include non-biocompatible materials, the hermeticity of the manifold 400 may prevent these materials from leaching into the patient's body, thus improving patient safety considerations.

[0030] In the exemplary arrangement shown in Figure 4B, the manifold 400 includes a first pump 450A in fluid communication with a first valve 460A via a first fluid passage 490A and a second pump 450B in fluid communication with a second valve 460B via a second fluid passage 490B. The first pump 450A and the first valve 460A can direct fluid from the manifold 400 through a first outlet port 430A to the reservoir 102 of the fluid-actuated device 100. The second pump 450B and the second valve 460B can direct fluid from the manifold 400 through a second outlet port 430B to the inflatable member 104 of the fluid-actuated device 100. The first pressure sensing device 420A senses the pressure of the fluid flowing between the manifold 400 and the reservoir 102. The second pressure sensing device 420 B senses the pressure of the fluid flowing between the manifold 400 and the inflatable member 104 .

[0031] In some examples, the first valve 460A and / or the second valve 460B are normally open valves. In an arrangement in which the first and second valves 460A, 460B are normally open valves, the second valve 460B can be actuated to close while the first pump 450A is operating to flow fluid from the manifold 400 to the reservoir 102. Similarly, the first valve 460A can be actuated to close while the second pump 450B is operating to flow fluid from the manifold 400 to the inflatable member 104. Normally open valves can enhance patient safety considerations, such as by allowing relief of pressure in the inflatable member 104 in the event of defects, failures, blockages, etc. in the fluidic architecture.

[0032] As discussed above, in some examples, control system components are incorporated into the pump assembly 500 to control and monitor operation of the pump assembly 500 and / or to enable communication with external device(s). For example, as shown in FIGS. 5A and 5B, the pump assembly 500 can incorporate an electronic control system 550 along with the fluidic architecture and components in the manifold 400. FIG. 5A illustrates a stacked arrangement of components in the manifold 400. FIG. 5B illustrates a vertical arrangement of components in the manifold 400. The electronic control system 550 can include, for example, a printed circuit board (PCB) 520, a power storage device 530, a battery 530, and other such electronic components. In some examples, the PCB 520 can include a processor to provide processing power, a memory, a communication module to enable communication with other electronic components and sensors, and the like, as well as with external devices, and control functions to enable control of the operation of the device. In some examples, the PCB 520 allows for processing of inputs, such as pressure and / or fluid flow measurements received from sensors of the device, application of control algorithms to the received inputs, and output of control functions based on application of the algorithms. The electronics can be received in an electronics compartment 540 of the pump assembly 500. The electronics can control the operation of fluid components received in fluid passages in the manifold 400 as described above, can monitor fluid flow rates and pressures, etc., in various portions of the flow through the manifold 400 based on information received from the first and second pressure sensing devices 420A, 420B, can communicate with external devices to allow user control and monitoring of the fluid-actuated device, etc. In this type of arrangement, the enclosed manifold 400 / housing 410 can isolate the fluid flowing through the manifold 400 from the electronics received in the electronics compartment 540.The hermeticity of manifold 400 can prevent fluid leakage into the electronics compartment and can prevent gas exchange between manifold 400 and the electronics compartment, thus improving the reliability, durability and functionality of the device and further improving patient safety considerations.

[0033] As mentioned above, the pump assembly of an implantable fluid-actuated device, such as device 100 described above with respect to FIGS. 2A and 2B, may include one or more pressure sensors. In the case of electronically controlled devices, the one or more pressure sensors may enable automatic regulation of the condition of the inflatable member and the fluid delivered to the inflatable member. The inclusion of one or more pressure sensors also improves diagnostic capabilities related to, among other things, fluid flow isolation and leakage problems, such as fluid flow in the fluid passageway, to and from the reservoir, and to and from the inflatable member. Identification of these types of flow-related problems allows for early intervention and correction. In some examples, the inclusion of one or more pressure sensors allows for dynamic control of the fluid pressure in the inflatable member, particularly taking into account fluctuations due to physical activity. In some examples, the inclusion of one or more pressure sensors allows for monitoring and control of the fluid flow rate. In some examples, the pressure sensor(s) included in the pump assembly of an implantable fluid-actuated device, such as device 100 described above with respect to Figures 2A and 2B, are formed from biocompatible materials and are relatively compact and power efficient to enable monitoring and control of fluid pressure and / or fluid flow through the device with minimal impact on device size and power consumption to maintain patient safety.

[0034] In some examples, the pump assembly includes multiple pressure sensors, such as the fluid architecture shown in FIG. 3, which includes two exemplary pressure sensors. In some examples, the pump assembly includes only one pressure sensor. In examples including only one pressure sensor, the pressure sensor can be positioned to measure pressure at or near the inflatable member. For example, the pressure sensor can be positioned to measure fluid pressure within the inflatable member and / or fluid pressure and / or fluid flow into and out of the inflatable member.

[0035] In some examples, an electronically controlled pump assembly may allow for the measurement of pressure at one or more locations within the pump assembly through the measurement of current at one or more locations within the pump assembly. In some examples, this may be accomplished through placement of a piezoelectric element, such as a piezoelectric diaphragm, at a desired location in combination with a passive check valve. An increase or decrease in pressure affects the deformation of the piezoelectric element. If deformation of the piezoelectric element (and corresponding change in voltage) is detected while the piezoelectric pump is not actuated, the change in voltage indicates a change in pressure, and thus the piezoelectric pump may also function as a pressure sensor.

[0036] 6A shows a piezoelectric diaphragm 610 disposed within a fluid chamber 620 of a piezoelectric diaphragm pump device that can enable pumping and pressure sensing of a fluid. In this example, the piezoelectric diaphragm 610 is disposed along an edge portion of the chamber 620 and includes a single layer disk 615 formed of a piezoelectric material (e.g., a piezoelectric ceramic disk) attached to a plate 625 or membrane 625 attached to an insulating diaphragm 635. A first check valve 631 is disposed on a first side of the chamber 620, e.g., an inlet end of the chamber 620, corresponding to a first end portion of the piezoelectric diaphragm 610, to regulate flow through the chamber 620 in a first direction. A second check valve 632 is disposed on a second side of the chamber 620, e.g., an outlet end of the chamber 620, corresponding to a second end portion of the piezoelectric diaphragm 610, to regulate flow through the chamber 620 in a second direction. As shown in Figure 6B, when voltage is applied or increased, the piezoelectric ceramic disc 615 deforms, causing a corresponding upstroke of the membrane 625 and diaphragm 635. The upstroke of the disc 615, which corresponds to this supply stroke, draws fluid into the chamber 620 through the first check valve 631, filling the chamber 620. As shown in Figure 6C, when the voltage is released or decreased, the disc 615 deforms, causing a corresponding downstroke. The downstroke of the disc 615, which corresponds to this pressure stroke, expels fluid from the chamber 620 through the second check valve 632. This pumping cycle can be repeated to continue pumping fluid into, out of, or through the chamber 620.

[0037] Figures 7A-7C show generally the operation of the dual piezoelectric pump and valve manifold arrangement, specifically, the operation of the dual piezoelectric pump and valve arrangement through first, second and third stages of a pumping cycle of a fluid through the dual piezoelectric pump and valve arrangement.

[0038] 7A, in a first stage, first check valve 631A and second check valve 632A are in a closed position, so that fluid does not flow into or out of first chamber 620A corresponding to first piezoelectric diaphragm 610A. Similarly, first check valve 631B and second check valve 632B are in a closed position, so that fluid does not flow into or out of second chamber 620B corresponding to second piezoelectric diaphragm 610B.

[0039] In response to the application of a voltage, the piezoelectric ceramic disc 615A and membrane 635A of the first piezoelectric diaphragm 610A perform an upstroke, or supply stroke, and the piezoelectric ceramic disc 615B and membrane 635B of the second piezoelectric diaphragm 610B perform a downstroke, or pressure stroke, from their respective first stage positions shown in FIG. 7A to their respective second stage positions shown in FIG. 7B. The voltage can be applied to the piezoelectric ceramic disc 615A based on the fluid pressure and / or fluid flow rate measured, for example, by any of the pressure sensors included in the fluidic architecture described above. As the first piezoelectric diaphragm 610A performs an upstroke, the pressure in the first chamber 620A decreases and the first check valve 631A opens to allow fluid to flow through the first check valve 631A into the first chamber 620A while the second check valve 632A remains closed. As the second piezoelectric diaphragm 610B performs a downstroke, the pressure in the second chamber 620B increases and the second check valve 632B opens, allowing fluid to flow from the second chamber 620B through the second check valve 632B, while the first check valve 631B remains closed.

[0040] In response to the removal of the voltage, the piezoelectric ceramic disc 615A and membrane 635A of the first piezoelectric diaphragm 610A perform a downstroke, i.e., pressure stroke, and the piezoelectric ceramic disc 615B and membrane 635B of the second piezoelectric diaphragm 610B perform an upstroke, i.e., supply stroke, from their respective second stage positions shown in FIG. 7B to their respective third stage positions shown in FIG. 7C. The removal of the voltage applied to the piezoelectric ceramic disc 615A can be based on the fluid pressure and / or fluid flow rate measured, for example, by one of the pressure sensors included in the fluidic architecture described above. When the first piezoelectric diaphragm 610A performs a downstroke, the pressure in the first chamber 620A increases, causing the first check valve 631A to close and the second check valve 632A to open, allowing fluid to flow into the fluid channel through the second check valve 632A toward the second chamber 620B. When the upstroke of the second piezoelectric diaphragm 610B is performed, the pressure in the second chamber 620B decreases and the first check valve 631B opens to allow fluid to flow into the second chamber 620B while the second check valve 632B remains closed.

[0041] Thus, the first, second and third stages of the pumping cycle of the dual piezoelectric pump and valve apparatus shown in Figures 7A-7C illustrate the refilling of fluid in the first chamber 620A and the evacuation of fluid accumulated in the second chamber 620B when progressing from the first stage (Figure 7A) to the second stage (Figure 7B), and the evacuation of fluid in the first chamber 620A and the refilling of fluid in the second chamber 620B when progressing from the second stage (Figure 7B) to the third stage (Figure 7C).

[0042] In the example described above with respect to Figures 7A-7C, the dual piezoelectric pump and valve apparatus includes a first check valve 631A, 631B and a second check valve 632A, 632B associated with flow through each chamber 620A, 620B, respectively. In some implementations, the operation of the second check valve 632A in the first chamber 620A and the first check valve 631B in the second chamber 620B may be replaced with a single valve (not shown in Figures 7A-7C) that can control flow between the first chamber 620A and the second chamber 620B in a manner similar to that described above with respect to Figures 7A-7C.

[0043] In some examples, current mode sensing can be applied to determine the pressure of a piezoelectric diaphragm pump. Since current and pressure are linearly correlated, the pressure can be inferred from the amount of current required to move the diaphragm. With this type of current mode sensing, the pressure can be sensed based on the amount of current required to move the diaphragm to fill / empty each chamber during each pumping cycle as described above.

[0044] In some examples, induced-response methods can be applied to determine pressure. Induced-response methods can take advantage of the ability of piezoelectric materials to convert motion into voltage (in addition to moving in response to the application of an electrical stimulus as described above). Because the electromechanical actuation and response of piezoelectric materials is related to alternating current (AC) signals, using the pump as a sensor as described above (e.g., in a piezoelectric diaphragm pump as described above) can only measure changes in pressure. In some examples, this can be overcome by controlling the input to one fluid chamber and measuring the output in another fluid chamber. FIG. 8 is a schematic diagram of an example dual piezoelectric pump manifold configuration, such as the dual piezoelectric pump and valve arrangement shown in FIGS. 7A-7C, having multiple chambers arranged in series. In this example arrangement, a first chamber (e.g., first chamber 620A) can be connected to a second chamber (e.g., second chamber 620B) by a fluid passageway. A known stimulus (i.e., a known voltage level or a known pulse level) is input to the first chamber and the output (voltage level or pulse amplitude) in the second chamber is detected. In some examples, the static pressure can be determined based on a known pulse input applied to the first chamber and the resulting pulse output measured in the second chamber.

[0045] As established above, the ability to accurately measure and monitor pressure in implantable fluid-actuated devices described herein is essential to the correct operation and effectiveness of the device, and to ensure patient safety. In some circumstances, it may be necessary to be able to determine atmospheric pressure and adjust the operation of the device accordingly to account for differences in calibrated atmospheric pressure levels during device operation and control. For example, the example device 100 described above operates on the principle of differential pressure. When pressure in the reservoir 102 is relatively high, there is a relatively low pressure in the inflatable member 104. Similarly, when pressure in the reservoir 102 is relatively low, there is a relatively high pressure in the inflatable member 104. For example, if the device 100 is calibrated at sea level, fluctuations in atmospheric pressure (i.e., above or below sea level) may affect pressure measurements and monitoring in the fluid channels of the device 100, affecting the operation of the device 100. By controlling the fluid pressure within the device 100, and particularly the fluid pressure at various different locations within the device 100, the pressure within the device 100 may be monitored and device operation controlled independent of atmospheric pressure.

[0046] For example, if there is no mechanism to account for atmospheric pressure changes, spikes, and the like, when atmospheric pressure increases or decreases (from the calibration pressure), the device 100 may erroneously pump fluid to the inflatable member 104 or vice versa to the reservoir 102 to account for the atmospheric pressure offset. 9A and 9B show example devices 100 described above in the form of an artificial urinary sphincter 100A and an example inflatable penile prosthesis 100B. Each of the example devices 100 includes an in-line pressure sensor. For example, a first in-line pressure sensor 191 (191A, 191B) is located near the reservoir 102, and a second in-line pressure sensor 192 (192A, 192B) is located near the inflatable member 104 of each device 100.

[0047] When calibrated, for example at sea level, any pressure difference between the reservoir 102 and the inflatable member 104 is accounted for, offset, or recognized based on the pressure measurements provided by the first and second pressure sensors 191, 192. When functioning properly, the first and second pressure sensors 191, 192 should experience the same pressure decrease or increase in response to a sudden increase in altitude or a sudden decrease in altitude, thus maintaining a substantially constant pressure level as shown in the graph of FIG. 10A. Using an in-line pressure sensor as described, the measurements taken by the first and second pressure sensors 191, 192 are transmitted to the electronic control system 108 for monitoring, and if there is an increase or decrease in pressure, an internal algorithm (e.g., applied or executed by a component of the control system 108 of the device 100) can use the pressure measurements to account for the difference and adapt the pumping of fluid through the device such that the correct inflation / deflation state of the inflatable member 104 is maintained.

[0048] Specifically, the graph shown in Figure 10B illustrates a decrease in system pressure in response to an increase in altitude. Without the first and second in-line pressure sensors 191, 192 as described above, and a control algorithm that corrects the pressure level to account for changes in altitude, the observed decrease in pressure could cause the device 100 to (erroneously) increase pumping of fluid to the inflatable member 104. This could result in over-pressurization of the cuff 104A, damage to the urethra, and / or device failure, or unintended inflation of the inflatable cylinder 104B. Similarly, the graph shown in Figure 10C illustrates an increase in system pressure in response to a decrease in altitude. Without the first and second in-line pressure sensors 191, 192 as described above, and a control algorithm to correct the pressure levels to account for changes in altitude, an observed increase in pressure could cause the device 100 to (incorrectly) reduce pumping of fluid to / inflate the inflatable member 104, causing fluid to be pumped back from the inflatable member 104 back into the reservoir 102. This could result in under-pressurization of the cuff 104A against the urethra and leakage for the patient, or unintended deflation of the inflatable cylinder 104B.

[0049] The graphs shown in Figures 11A-11D illustrate the effect of a single sudden impulse or shock seen on the inflatable member 104 due to various physical actions, such as, for example, motion, that may temporarily affect the inflatable member 104 and cause intermittent pressure spikes. Under normal calibrated (and impulse-free as described above) conditions, any pressure difference between the reservoir 102 and the inflatable member 104 is accounted for, offset, or recognized based on the pressure measurements provided by the first and second pressure sensors 191, 192, as described above and as shown in Figures 11A and 11C. Furthermore, based on the in-line arrangement of the first and second pressure sensors 191, 192, the system can detect that in this scenario, a sudden pressure spike as shown in Figure 11D is only detected by the second pressure sensor 192 (at or near the inflatable member 104) and not by the first pressure sensor 191 (at or near the reservoir 102) as shown in Figure 11B. As a result, the system can take action to increase or decrease pumping action, or no action, based on established decision algorithms. For example, no action is taken if continuous pressure monitoring detects that the pressure increase is not sustained for a period of time and the pressure returns to within the expected calibration range, as shown in FIG. 11D. This allows the device 100 to adapt relatively quickly to a particular usage scenario, while also enhancing patient safety and comfort.

[0050] The graphs shown in Figures 12A-12D illustrate the effect of a single sudden impulse or shock seen on the reservoir 102 due to various physical actions, such as a tipping, that may temporarily affect the reservoir 102 causing intermittent pressure spikes. Under normal calibrated (and impulse-free as described above) conditions, any pressure difference between the reservoir 102 and the inflatable member 104 is accounted for, offset or recognized based on the pressure measurements provided by the first and second pressure sensors 191, 192, as described above and as shown in Figures 12A and 12C. Furthermore, based on the in-line arrangement of the first and second pressure sensors 191, 192, the system is able to detect that in this scenario, a sudden pressure spike as shown in Figure 12B is only detected by the first pressure sensor 191 (at or near the reservoir 102) and not the second pressure sensor 192 (at or near the inflatable member 104) as shown in Figure 12B. As a result, the system can take action to increase or decrease pumping action, or no action, based on established decision algorithms. For example, no action is taken if continuous pressure monitoring detects that the pressure increase is not sustained for a period of time and the pressure returns to within the expected calibration range, as shown in FIG. 12B. This allows the device 100 to adapt relatively quickly to a particular usage scenario, while also enhancing patient safety and comfort.

[0051] The graphs shown in Figures 13A-13D show the effect of the set pressure values ​​between the reservoir 102 and the inflatable member 104 differing or drifting over a relatively long period of time, or the time to reach the set pressure value increasing significantly. These events may indicate a blockage of one of the fluid paths of the device 100, or other type of damage or malfunction of the device 100, and may provide notification to the patient and / or physician for corrective action. In normal operation, the offset between the pressure levels measured by the first and second in-line pressure sensors 191, 192 should remain essentially constant, as shown in Figures 13A and 13C. If a component fails, leaks, blocks, or other such faults, a pressure spike or pressure reduction will occur, as shown in Figures 13B and 13D, depending on the type of failure and the location of the failure within the device 100. When a sustained pressure reduction or spike is detected, an alert may be issued to the patient and / or physician for correction, thus increasing patient safety and comfort.

[0052] As described above, the exemplary in-line pressure sensors 191, 192 shown in FIGS. 9A and 9B can be disposed in the fluid passage of the implantable fluid-actuated device 100. In some examples, the in-line pressure sensors 191, 192 can include a diaphragm disposed in the fluid passage. For example, the first pressure sensor 191 can include a diaphragm disposed in the fluid passage facing the reservoir 102, and the second pressure sensor 192 can include a diaphragm disposed in the fluid passage facing the inflatable member 104. Deflection of the diaphragm can be detected / measured and an algorithm (e.g., executed by the electronic control system 108) can convert the detected movement or deflection of the diaphragm into pressure. In some examples, a strain gauge disposed on the diaphragm can measure the deflection of the diaphragm. FIG. 14A shows an example of a strain gauge 950 attached to a diaphragm in a fluid passage of the pump assembly 106. In some examples, the diaphragm is formed of a biocompatible material, such as titanium. In some examples, the diaphragm is coated with a resilient material, such as, for example, silicone and ceramic materials, that provides a moisture barrier over the diaphragm while also allowing transmission of signals from the strain gauge. In some examples, the device 100 can communicate with an external device (e.g., via a communication module in the electronic control system 108). Communication with an external device can allow for the exchange of information, such as, for example, atmospheric pressure measurements (allowing the internal device 100 to adjust pressure as needed), internal pressure measurements, and alerts.

[0053] As discussed above, the ability to detect non-normal pressure level(s) within the device 100 and adapt operation of the device 100 in response to the detection of non-normal pressure level(s) enhances patient safety and device effectiveness. For example, as discussed above with respect to FIGS. 11A-11D, when a spike or increase in pressure is detected, the device 100 can adjust the pumping action. In some circumstances, the decision to adjust the pumping action can be based on the duration for which the increased pressure is observed. For example, in the case of the artificial urinary sphincter 100A, pressure may increase relatively quickly when the catheter is inserted, especially if the cuff 104A is not deflated prior to the insertion of the catheter. For example, in some circumstances, the patient may be incapacitated and / or unable to communicate the presence of an implanted artificial urinary sphincter. Inserting the catheter with the cuff 104A inflated will cause a rapid increase in pressure within the device 100A that continues to persist and / or increase as the catheter is inserted. In this example, detection of such a sustained pressure spike can cause electronic control system 108A to actuate pump assembly 106A to deflate cuff 104A, thus opening cuff 104A to allow insertion of a catheter without compromising cuff 104A and / or the urethra.

[0054] In some examples, the pressure spikes are detected by a pressure sensor in the fluid path of the device, including, for example, the piezoelectric element and pressure transducer described above. In some examples, the pressure spikes are detected based on dynamic pressure changes in the piezoelectric element. As described above, a diaphragm disposed in the fluid path facing the reservoir 102A and the cuff 104A deflects as the fluid pressure changes. Normal and deflected states of the diaphragm 615 are shown in FIG. 14B and FIG. 14C. The dynamic pressure in response to the insertion of the catheter as described above generates a voltage change that can be measured by the strain gauge(s) 950. The voltage change indicates the change in pressure due to the insertion of the catheter. The electronic control system 108 can process the detected pressure changes and control the pump assembly 106 to enable the deflation / release of the cuff 104A.

[0055] While certain features of the described implementations have been described herein, many modifications, substitutions, changes and equivalents will occur to those skilled in the art, and it is therefore to be understood that the appended claims are intended to cover all such modifications and changes that are within the scope of the present embodiments. [Explanation of symbols]

[0056] 100B Inflatable penile prosthesis 102B Fluid Reservoir 103B First Conduit 104B Expandable cylinder 105B Second Conduit 106B Pump Assembly 108B Control System

Claims

1. 1. An implantable fluid-actuated inflatable device, comprising: A fluid reservoir; and An inflatable member; a pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member; an electronic control system configured to control operation of the pump assembly; at least one pressure sensing device configured to communicate with the electronic control system; the pump assembly comprising: Housing and at least one valve and at least one pump disposed within a fluid passageway defined within the housing; a first fluid port in fluid communication with the fluid reservoir; a second fluid port in fluid communication with the inflatable member; a manifold including The at least one pressure sensing device a first pressure sensing device configured to measure and transmit pressure within the fluid reservoir to the electronic control system; a second pressure sensing device configured to measure and transmit pressure within the inflatable member to the electronic control system; the electronic control system is configured to control operation of the pump assembly to maintain the pressure in the inflatable member at a predetermined pressure level while disabling operation of the at least one pump if a pressure spike is detected in only one of the pressure in the fluid reservoir and the pressure in the inflatable member that does not result in a sustained pressure increase for a period of time. An implantable fluid-operated inflatable device comprising:

2. The at least one valve and the at least one pump include: a first pump and a first valve disposed in a first fluid passage in fluid communication with the first fluid port; a second pump and a second valve disposed in a second fluid passage in fluid communication with the second fluid port; 13. The implantable fluid-actuated inflatable device of claim 1, comprising:

3. The at least one pressure sensing device a first pressure sensing device disposed within the first fluid passageway and configured to measure a pressure of fluid flowing through the first fluid port and to transmit the measured pressure to the electronic control system; a second pressure sensing device disposed within the second fluid passageway and configured to measure a pressure of fluid flowing through the second fluid port and to transmit the measured pressure to the electronic control system; 3. The implantable fluid-actuated inflatable device of claim 2, comprising:

4. The at least one valve and the at least one pump include a dual piezoelectric pump, the dual piezoelectric pump comprising: A first piezoelectric pump; a second piezoelectric pump; a fluid channel that allows fluid communication between the first piezoelectric pump and the second piezoelectric pump; 4. The implantable fluid-actuated inflatable device of claim 1 or 3, comprising:

5. The first piezoelectric pump includes: A first chamber; a first piezoelectric diaphragm disposed along an edge portion of the first chamber and configured to be selectively energized in response to fluid pressure sensed by at least one of the first pressure sensing device or the second pressure sensing device; a first check valve at an inlet end of the first chamber; a second check valve at an outlet end of the first chamber selectively providing fluid communication between the first chamber and the fluid channel; and the second piezoelectric pump comprising: A second chamber; and a second piezoelectric diaphragm disposed along an edge portion of the second chamber and configured to be selectively energized in response to fluid pressure sensed by at least one of the first pressure sensing device or the second pressure sensing device; a first check valve at an inlet end of the second chamber selectively providing fluid communication between the fluid channel and the second chamber; a second check valve at an outlet end of the second chamber; 5. The implantable fluid-actuated inflatable device of claim 4, comprising:

6. The pumping cycle of the dual piezoelectric pump is a first stage including a supply stroke of the first piezoelectric diaphragm coordinated with a pressure stroke of the second piezoelectric diaphragm; a second stage including a pressure stroke of the first piezoelectric diaphragm coordinated with a supply stroke of the second piezoelectric diaphragm; 6. The implantable fluid-actuated inflatable device of claim 5, comprising:

7. In the first stage, fluid is drawn into the first chamber through the first check valve of the first piezoelectric pump and fluid is expelled from the second chamber through the second check valve of the second piezoelectric pump; 7. The implantable fluid-actuated inflatable device of claim 6, wherein in the second stage, fluid is exhausted from the first chamber into the fluid channel through the second check valve of the first piezoelectric pump and fluid is drawn from the fluid channel into the second chamber through the first check valve of the second piezoelectric pump.

8. 8. The implantable fluid-actuated inflatable device of claim 1, wherein the housing of the manifold is formed of an injection molded metal material, and the at least one pump and the at least one valve are disposed within a sealed fluid passage defined in the injection molded metal material such that the manifold is a sealed manifold.

9. The implantable fluid-actuated inflatable device of any of claims 1 to 7, wherein the pump assembly includes a pump assembly housing, the manifold and the electronic control system being received within the pump assembly housing.

10. 10. The implantable fluid-actuated inflatable device of claim 9, wherein the manifold is a closed manifold and components of the electronic control system within the pump assembly housing are isolated from fluid flowing through the closed manifold.

11. The at least one pressure sensing device the first pressure sensing device disposed proximate a fluid port of the fluid reservoir; the second pressure sensing device disposed proximate to a fluid port of the inflatable member; 13. The implantable fluid-actuated inflatable device of claim 1, comprising:

12. The first pressure sensing device is a first diaphragm disposed in a fluid passage adjacent to the fluid reservoir and facing the fluid reservoir; at least one first strain gauge attached to the first diaphragm and configured to measure a deflection of the first diaphragm and transmit the measured deflection to the electronic control system; the second pressure sensing device comprising: a second diaphragm disposed in the fluid passage adjacent the fluid port of the inflatable member and facing the inflatable member; at least one second strain gauge attached to the second diaphragm and configured to measure a deflection of the second diaphragm and transmit the measured deflection to the electronic control system; 12. The implantable fluid-actuated inflatable device of claim 11, comprising:

13. The implantable fluid-operated inflatable device of any one of claims 1 to 11, wherein the at least one pressure sensing device comprises at least one piezoelectric element disposed within a fluid passage of the implantable fluid-operated inflatable device, the at least one piezoelectric element configured to sense a fluid pressure level within the fluid passage based on an input voltage level applied to the piezoelectric element and an output voltage level measured at the piezoelectric element.

14. The electronic control system includes: receiving a pressure level measurement from the at least one pressure sensing device; applying a control algorithm based on the received pressure level measurements; controlling operation of the at least one valve and the at least one pump in accordance with the applied control algorithm.

14. The implantable fluid-actuated inflatable device of claim 1, further comprising a printed circuit board including a processor configured to:

15. 15. An implantable fluid-operated inflatable device according to any one of claims 1 to 14, wherein the implantable fluid-operated inflatable device is an artificial urinary sphincter or an inflatable penile prosthesis.

16. 1. An implantable fluid-actuated inflatable device, comprising: A fluid reservoir; and An inflatable member; a pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member; an electronic control system for controlling operation of the pump assembly; at least one pressure sensing device in communication with the electronic control system; the pump assembly comprising: Housing and at least one valve and at least one pump disposed within a fluid passageway defined within the housing; a first fluid port in fluid communication with the fluid reservoir; a second fluid port in fluid communication with the inflatable member; a manifold including The at least one pressure sensing device a first pressure sensing device configured to measure and transmit pressure within the fluid reservoir to the electronic control system; a second pressure sensing device configured to measure and transmit pressure within the inflatable member to the electronic control system; the electronic control system is configured to control operation of the pump assembly to maintain the pressure in the inflatable member at a predetermined pressure level while disabling operation of the at least one pump if a pressure spike is detected in only one of the pressure in the fluid reservoir and the pressure in the inflatable member that does not result in a sustained pressure increase for a period of time. An implantable fluid-operated inflatable device comprising:

17. The at least one valve and the at least one pump include: a first pump and a first valve disposed in a first fluid passage in fluid communication with the first fluid port; a second pump and a second valve disposed in a second fluid passage in fluid communication with the second fluid port; 20. The implantable fluid-actuated inflatable device of claim 16, comprising:

18. The at least one pressure sensing device a first pressure sensing device disposed within the first fluid passageway and configured to measure a pressure of fluid flowing through the first fluid port and to transmit the measured pressure to the electronic control system; a second pressure sensing device disposed within the second fluid passageway and configured to measure a pressure of fluid flowing through the second fluid port and to transmit the measured pressure to the electronic control system; 20. The implantable fluid-actuated inflatable device of claim 17, comprising:

19. The at least one valve and the at least one pump form a dual piezoelectric pump and valve manifold, the dual piezoelectric pump and valve manifold comprising: A first piezoelectric pump; a second piezoelectric pump; a fluid channel that allows fluid communication between the first piezoelectric pump and the second piezoelectric pump; 20. The implantable fluid-actuated inflatable device of claim 16, comprising:

20. The first piezoelectric pump includes: A first chamber; a first piezoelectric diaphragm disposed along an edge portion of the first chamber and configured to be selectively energized in response to fluid pressure sensed by at least one of the first pressure sensing device or the second pressure sensing device; a first check valve at an inlet end of the first chamber; a second check valve at an outlet end of the first chamber selectively providing fluid communication between the first chamber and the fluid channel; and the second piezoelectric pump comprising: A second chamber; and a second piezoelectric diaphragm disposed along an edge portion of the second chamber and configured to be selectively energized in response to fluid pressure sensed by at least one of the first pressure sensing device or the second pressure sensing device; a first check valve at an inlet end of the second chamber selectively providing fluid communication between the fluid channel and the second chamber; a second check valve at an outlet end of the second chamber; 20. The implantable fluid-actuated inflatable device of claim 19, comprising:

21. The pumping cycle of the dual piezoelectric pump is a first stage including a supply stroke of the first piezoelectric diaphragm coordinated with a pressure stroke of the second piezoelectric diaphragm; a second stage including a pressure stroke of the first piezoelectric diaphragm coordinated with a supply stroke of the second piezoelectric diaphragm; 21. The implantable fluid-actuated inflatable device of claim 20, comprising:

22. In the first stage, fluid is drawn into the first chamber through the first check valve of the first piezoelectric pump and fluid is expelled from the second chamber through the second check valve of the second piezoelectric pump; 22. The implantable fluid-actuated inflatable device of claim 21, wherein in the second stage, fluid is exhausted from the first chamber into the fluid channel through the second check valve of the first piezoelectric pump and fluid is drawn from the fluid channel into the second chamber through the first check valve of the second piezoelectric pump.

23. 17. The implantable fluid-actuated inflatable device of claim 16, wherein the housing of the manifold is formed of an injection molded metal material, and the at least one pump and the at least one valve are disposed within a sealed fluid passage defined in the injection molded metal material such that the manifold is a sealed manifold.

24. 17. The implantable fluid-actuated inflatable device of claim 16, wherein the pump assembly includes a pump assembly housing, the manifold and the electronic control system being received within the pump assembly housing.

25. 25. The implantable fluid-actuated inflatable device of claim 24, wherein the manifold is a sealed manifold and components of the electronic control system within the pump assembly housing are isolated from fluid flowing through the sealed manifold.

26. The at least one pressure sensing device the first pressure sensing device disposed proximate a fluid port of the fluid reservoir; the second pressure sensing device disposed proximate to a fluid port of the inflatable member; 20. The implantable fluid-actuated inflatable device of claim 16, comprising:

27. The first pressure sensing device is a first diaphragm disposed in a fluid passage adjacent to the fluid reservoir and facing the fluid reservoir; at least one first strain gauge attached to the first diaphragm and configured to measure a deflection of the first diaphragm and transmit the measured deflection to the electronic control system; the second pressure sensing device comprising: a second diaphragm disposed in the fluid passage adjacent the fluid port of the inflatable member and facing the inflatable member; at least one second strain gauge attached to the second diaphragm and configured to measure deflection of the second diaphragm and transmit the measured deflection to the electronic control system; 27. The implantable fluid-actuated inflatable device of claim 26, comprising:

28. 17. The implantable fluid-actuated inflatable device of claim 16, wherein the at least one pressure sensing device comprises at least one piezoelectric element disposed within a fluid passage of the implantable fluid-actuated inflatable device, the at least one piezoelectric element configured to sense a fluid pressure level within the fluid passage based on an input voltage level applied to the piezoelectric element and an output voltage level measured at the piezoelectric element.

29. The electronic control system includes: receiving a pressure level measurement from the at least one pressure sensing device; applying a control algorithm based on the received pressure level measurements; controlling operation of the at least one valve and the at least one pump in accordance with the applied control algorithm.

20. The implantable fluid-actuated inflatable device of claim 16, further comprising a printed circuit board including a processor configured to:

30. 17. The implantable fluid-operated inflatable device of claim 16, wherein the implantable fluid-operated inflatable device is an artificial urinary sphincter or an inflatable penile prosthesis.

31. 1. An implantable fluid-actuated inflatable device, comprising: A fluid reservoir; and An inflatable member; a pump assembly received within a housing and configured to transfer fluid between the fluid reservoir and the inflatable member, the pump assembly including a manifold and a pump and valve arrangement received within the manifold; an electronic control system configured to control operation of the pump and valve arrangement; at least one pressure sensing device configured to communicate with the electronic control system; The at least one pressure sensing device a first pressure sensing device configured to measure and transmit pressure within the fluid reservoir to the electronic control system; a second pressure sensing device configured to measure and transmit pressure within the inflatable member to the electronic control system; the electronic control system is configured to control operation of the pump assembly to maintain the pressure in the inflatable member at a predetermined pressure level while disabling operation of the at least one pump if a pressure spike is detected in only one of the pressure in the fluid reservoir and the pressure in the inflatable member that does not result in a sustained pressure increase for a period of time. An implantable fluid-operated inflatable device comprising:

32. 32. The implantable fluid-actuated inflatable device of claim 31 , wherein the manifold is a sealed manifold and the electronic control system includes a first portion received within an electronics compartment of the housing isolated from fluid flowing through the manifold.

33. 33. The implantable fluid-operated inflatable device of claim 32, wherein the electronic control system includes a second portion configured to be external to the implantable fluid-operated inflatable device and to communicate with the first portion of the electronic control system, the second portion configured to receive user input and output information to a user.

34. the pump and valve apparatus being a dual piezoelectric pump and valve apparatus including a first piezoelectric pump in fluid communication with a second piezoelectric pump via a fluid channel; The first piezoelectric pump includes: A first chamber; a first piezoelectric element and a diaphragm disposed along an edge portion of the first chamber; a first check valve at an inlet end of the first chamber; a second check valve at an outlet end of the first chamber selectively providing fluid communication between the first chamber and the fluid channel; and the second piezoelectric pump comprising: A second chamber; and a second piezoelectric element and a diaphragm disposed along an edge portion of the second chamber; a first check valve at an inlet end of the second chamber selectively providing fluid communication between the fluid channel and the second chamber; a second check valve at an outlet end of the second chamber; 32. The implantable fluid-actuated inflatable device of claim 31 , comprising:

35. the electronic control system is configured to, in an inflation mode, alternately apply voltage inputs to the first piezoelectric element and the second piezoelectric element to cause fluid to flow through the dual piezoelectric pump in a first direction from the fluid reservoir toward the inflatable member; 35. The implantable fluid-actuated inflatable device of claim 34, wherein the electronic control system is configured to, in a deflation mode, alternately apply voltage inputs to the first piezoelectric element and the second piezoelectric element to cause fluid to flow in a second direction from the inflatable member toward the fluid reservoir through the dual piezoelectric pump.

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