CN117062583A - Fluid control system for an implantable inflatable device - Google Patents

Abstract

An implantable fluid handling device may include a fluid reservoir configured to contain a fluid, an inflatable member, and a pump assembly configured to transfer the fluid between the fluid reservoir and the inflatable member. The pump assembly may include one or more fluid pumps and one or more valves. The one or more valves may be normally open valves, normally closed valves, or a combination thereof. One or more sensing devices may be positioned within the fluid channel of the fluid handling device. The electronic control system may control operation of the pump assembly based on fluid pressure measurements and/or fluid flow measurements received from one or more sensing devices. Variable voltages may be applied to the pump and/or control of the valve based on varying atmospheric conditions and fluid pressure and/or flow measurements processed by the electronic control system.

Description

Fluid control system for an implantable inflatable device

Cross Reference to Related Applications

The present application is a continuation of and claims priority to U.S. non-provisional patent application Ser. No.17/655,952 entitled "FLUID CONTROL SYSTEM FOR AN IMPLANTABLE INFLATABLE DEVICE" filed on 3 month 22 of 2022, which claims priority to U.S. provisional patent application Ser. No.63/200,738 entitled "FLUID CONTROL SYSTEM FOR AN IMPLANTABLE INFLATABLE DEVICE" filed on 25 of 3 month 2021, the disclosure of which is incorporated herein by reference in its entirety.

The present application also claims priority from U.S. provisional patent application No.63/200,738 filed on 25/3/2021, the disclosure of which is incorporated herein by reference in its entirety.

Technical Field

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

Background

Active implantable fluid-operated devices typically include one or more pumps that regulate fluid flow between different portions of the implantable device. One or more valves may be located within the fluid channels of the device to direct and control the flow of fluid to effect expansion, contraction, pressurization, depressurization, activation, deactivation, etc. of the different fluid-filled implant components of the device. In some implantable fluid-operated devices, sensors may be used to monitor fluid pressure and/or fluid volume and/or fluid flow within a fluid channel of the device. Accurate monitoring of conditions within the device, including pressure monitoring and flow monitoring, may provide improved control of device operation, improved diagnostics, and improved device efficacy. In addition, sensors may be used to monitor external conditions of the device, including acceleration, angle, barometric pressure, and temperature, which may aid in determining the device's mode of operation.

Disclosure of Invention

In a general aspect, an implantable fluid-operated inflatable device includes a fluid reservoir; an inflatable member; and a fluid control system configured to transfer fluid between the fluid reservoir and the expandable member. The fluid control system may include a housing; at least one valve and at least one pump located in a fluid channel within the housing; a first fluid port in fluid communication with the fluid reservoir; and a second fluid port in fluid communication with the expandable member. The implantable fluid-operated inflatable device may further comprise at least one pressure sensing device configured to sense a fluid pressure in the implantable fluid-operated inflatable device; and an electronic control system configured to receive the pressure sensed by the at least one pressure sensing device and to control the at least one valve and/or the at least one pump in response to the received pressure.

In some embodiments, the at least one valve and the at least one pump comprise a combined pump and valve device positioned in series between the reservoir and the expandable member, comprising a chamber; a diaphragm positioned along an edge portion of the chamber; a piezoelectric element mounted on the diaphragm; a first valve positioned at a first end portion of the chamber corresponding to the first end portion of the piezoelectric element; and a second valve positioned at a second end portion of the chamber corresponding to the second end portion of the piezoelectric element. In some embodiments, in a first mode, wherein fluid moves through the combined pump and valve device in a first direction to transfer fluid from the reservoir to the expandable member to expand the expandable member, a first pumping cycle of the combined pump and valve device may include a first supply stroke in which fluid is drawn into the chamber through the first valve while the second valve is closed; and a first pressure stroke in which fluid exits the chamber through the second valve while the first valve is closed. In a second mode, wherein fluid moves through the combined pump and valve device in a second direction to transfer fluid from the expandable member to the reservoir, thereby collapsing the expandable member, a second pumping cycle of the combined pump and valve device may include a second supply stroke in which fluid is drawn into the chamber through the second valve while the first valve is closed; and a second pressure stroke in which fluid exits the chamber through the first valve while the second valve is closed. In some embodiments, the first supply stroke and the first pressure stroke are alternately and repeatedly performed until an inflation pressure of the inflatable member is achieved based on the pressure or other characteristic sensed by the at least one sensing device; and the second supply stroke and the second pressure stroke are alternately and repeatedly performed until a systolic pressure is reached based on the pressure sensed by the at least one sensing device.

In some embodiments, at least one valve is a piezoelectric valve comprising a valve base or body; at least one inlet port formed in the valve base or body; at least one outlet port formed in the valve base or body; a diaphragm coupled to the valve base or body; and a piezoelectric element mounted on the diaphragm, wherein a voltage applied to the piezoelectric element is a variable voltage to maintain a set state of the fluid-operated inflatable device based on a pressure detected in the fluid passage of the valve relative to a detected pressure outside the valve. The variable voltage applied to the piezoelectric element to maintain the set state of the fluid-operated inflatable device may be based on a pressure detected in the fluid passage of the valve relative to an atmospheric pressure detected by the electronic control system. The variable voltage applied to the piezoelectric element may adjust the position of the piezoelectric element and the diaphragm to adjust at least one of the fluid pressure or the fluid flow rate to adjust for atmospheric conditions and correspond to a set state of the fluid-controlled inflatable device. The voltage applied to the piezoelectric element may be selected from a calibration curve associated with the piezoelectric valve, the calibration curve being accessible in a memory of the electronic control system.

In some embodiments, the at least one valve is a normally open piezoelectric valve configured to transition from a normally open state to a closed state in response to application of a voltage to the piezoelectric element and to return to the normally open state in response to release of the voltage. The normally open piezoelectric valve may be configured to remain closed for a period of time after the voltage is released and transition to the normally open state in response to dissipation of the electrical bias built up in the piezoelectric element. In some embodiments, the normally open piezoelectric valve includes a resistor electrically connected to the piezoelectric element. The resistor may be configured to control dissipation of the electrical bias accumulated in the piezoelectric element such that the normally open piezoelectric valve transitions from a closed state to a normally open state within a set period of time after the voltage is released.

In some embodiments, the piezoelectric valve is a normally closed piezoelectric valve configured to transition from a normally closed state to an open state in response to application of a voltage to the piezoelectric element and to return to the normally closed state in response to release of the voltage. The normally-closed piezoelectric valve may include a plunger movably positioned within the fluid passage of the normally-closed piezoelectric valve, wherein the plunger seals against the valve base in a normally-closed state to restrict flow through the fluid passage and is spaced apart from the valve base in an open state to open the fluid passage. In a normally closed state of the normally closed piezoelectric valve, a back pressure applied to the plunger through the at least one outlet maintains a sealing position of the plunger against the valve seat in response to fluctuations in fluid pressure at the at least one inlet.

In some embodiments, an electronic control system includes a printed circuit board including a memory configured to store at least one control algorithm, a communication module configured to communicate with one or more external devices, and a processor configured to receive pressure level measurements from at least one sensing device; applying at least one control algorithm based on the received pressure level measurements; and controlling operation of the at least one valve and the at least one pump according to the at least one control algorithm applied.

In some embodiments, the implantable fluid-operated inflatable device is an artificial urinary sphincter or an inflatable penile prosthesis.

In another general aspect, a method of controlling an implantable fluid-operated inflatable device includes: receiving, by a processor of the inflatable device, a fluid pressure measurement from a pressure sensing device within a fluid passageway of the inflatable device; comparing, by the processor, the measured pressure received from the pressure sensing device with a pressure external to the fluid channel; and controlling, by the processor, the circuit based on the comparison to apply a voltage to the piezoelectric element of the piezoelectric valve of the inflatable device to maintain the set state of the inflatable device.

In some embodiments, controlling the circuit to apply a voltage to the piezoelectric element includes detecting a change in atmospheric pressure relative to a calibration condition of the inflatable device based on the comparison; selecting, by the processor, a voltage to be applied to a piezoelectric element of a piezoelectric valve of the inflatable device from a previously stored look-up table in response to a detected change in atmospheric pressure; and applying a selected voltage to the piezoelectric element to maintain the set condition of the inflatable device under varying atmospheric conditions.

In some embodiments, the piezoelectric valve is a normally open piezoelectric valve, and wherein the control circuit to apply a voltage to the piezoelectric element includes a resistor in the control circuit such that the electrical bias accumulated in the piezoelectric element dissipates over a set period of time to return the normally open piezoelectric valve to a normally open state.

In some embodiments, the piezoelectric valve is a normally closed piezoelectric valve, and the method further comprises detecting fluctuations in fluid pressure at an inlet portion of the piezoelectric valve; and applying a back pressure at an outlet portion of the piezoelectric valve in response to fluctuations in fluid pressure at the inlet portion to maintain a closed state of the normally closed piezoelectric valve.

In some implementations, the method further includes receiving, by a control module of the processor, user input from an external device in communication with the processor; and adjusting at least one of a fluid pressure or a fluid flow rate in the inflatable device in response to the received user input.

Drawings

Fig. 1 is a block diagram of an implantable fluid handling device according to one aspect.

Fig. 2A and 2B illustrate an exemplary implantable fluid-operated device according to one aspect.

Fig. 3A and 3B are schematic illustrations of a fluid structure of an implantable fluid handling device according to one aspect.

Fig. 4A and 4B illustrate an open state and a closed state, respectively, of a normally open piezoelectric valve according to one aspect.

Fig. 5A-5C illustrate a fully open state, a partially open state, and a closed state of a piezoelectric valve according to one aspect.

Fig. 6A-6C illustrate operation of a normally open valve according to one aspect.

Fig. 7 is a graph of a variable closed voltage curve.

8A-8C illustrate operation of an exemplary valve according to one aspect.

Fig. 9 is a schematic illustration of the fluid structure of an implantable fluid handling device including a valve.

10A-10D illustrate operation of an exemplary pump and valve arrangement according to one aspect.

Detailed Description

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

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

Generally, these embodiments are directed to a human implant. The term patient or user may hereinafter be used for persons who benefit from the medical devices or methods disclosed in the present disclosure. For example, the patient may be a person in whom the medical device is implanted or a person using the methods for operating the medical device disclosed in the present disclosure.

Fig. 1 is a block diagram of an exemplary implantable fluid-operated inflatable device 100. The example apparatus 100 illustrated in fig. 1 includes a fluid reservoir 102, an expandable member 104, and a fluid control system 106 including fluid components, such as one or more pumps, one or more valves, etc., configured to transfer fluid between the fluid reservoir 102 and the expandable member 104. The fluid control system 106 may include one or more sensing devices that sense conditions within the fluid system of the device 100, such as fluid pressure, fluid flow rate, etc. In some embodiments, the example apparatus 100 includes an electronic control system 108. The electronic control system 108 may provide monitoring and/or control of the operation of the various fluid components of the fluid control system 106, and/or communication with one or more sensing devices within the implantable fluid-operated inflatable device 100, and/or communication with one or more external devices. In some embodiments, the electronic control system 108 includes, for example, a processor, memory, communication module, and other such components configured to provide for operation and control of the implantable fluid-operated inflatable device 100. For example, the communication module may provide communication with one or more external devices. One or more external devices may be configured to receive user inputs and transmit the user inputs to the electronic control system 108 for processing, operation, and control of the device 100. The electronic control system 108 may transmit the operation information to an external device through a communication module for use by a user. The fluid reservoir 102, the expandable member 104, and the fluid control system 106 may be implanted internally within the patient. In some embodiments, the electronic control system 108 is coupled to or incorporated into the housing of the fluid control system 106. In some embodiments, at least a portion of the electronic control system 108 is physically separate from the fluid control system 106. In some embodiments, 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 embodiments, some of the modules of the electronic control system 108 are included in an external device that communicates with other modules of the electronic control system 108 included within the implantable device 100. In some embodiments, the operation of the implantable fluid-operated inflatable device 100 may be manually controlled.

In some examples, electronic monitoring and control of the fluid handling device 100 may provide improved patient control, improved patient comfort, and improved patient safety of the device. In some examples, electronic monitoring and control of the fluid handling device 100 may provide opportunities for customizing the operation of the device 100 by a physician without further surgical intervention.

The exemplary implantable fluid handling device 100 may represent many different types of implantable fluid handling devices. For example, the device 100 shown in fig. 1 may represent an artificial urinary sphincter 100A as shown in fig. 2A. The example artificial urinary sphincter 100A shown in fig. 2A includes a fluid control system 106A including fluid components, such as pumps, valves, etc., positioned in a fluid path and an electronic control system 108A configured to provide transfer of fluid between the reservoir 102A and the inflatable cuff 104A. The fluid components of the fluid control system 106A and the electronic components of the electronic control system 108A may be housed in a housing 110A. The first conduit 103A connects the first fluid port 107A of the fluid control system 106A/electronic control system 108A housed in the housing 110A with the reservoir 102A. The second conduit 105A connects the second fluid port 109A of the fluid control system 106A/electronic control system 108A contained in the housing 110A with the inflatable cuff 104A. In some examples, the device 100 shown in fig. 1 may represent an inflatable penile prosthesis 100B as shown in fig. 2B. The example penile prosthesis 100B shown in fig. 2B includes a fluid control system 106B that includes fluid components, such as pumps, valves, etc., positioned in a fluid passageway and an electronic control system 108B configured to provide fluid transfer between the fluid reservoir 102B and the inflatable cylinder 104B. The fluid components of the fluid control system 106B and the electronic components of the electronic control system 108B may be housed in a housing 110B. The first conduit 103B connects the first fluid port 107B of the fluid control system 106B/electronic control system 108B housed in the housing 110B with the reservoir 102B. One or more second conduits 105B connect one or more second fluid ports 109B of the fluid control system 106A/electronic control system 108A housed in the housing with the inflatable column 104B. The principles described herein may be applied to these and other types of implantable fluid-operated inflatable devices that rely on pump assemblies including various fluid components to provide fluid transfer between different fluid-filled implantable components to effect inflation, deflation, pressurization, depressurization, deactivation, etc. for efficient operation. The example devices 100A, 100B shown in fig. 2A and 2B include electronic control systems 108A, 108B to provide monitoring and control of pressure and/or fluid flow through the respective devices 100A, 100B. Some of the principles to be described herein may also be applied to manually controlled implantable fluid operated inflatable devices.

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

Fig. 3A and 3B are schematic illustrations of an exemplary fluidic structure for an implantable fluid handling device according to one aspect. The fluid structure of the implantable fluid handling device may include other orientations of fluid channels, valves, pressure sensors, and other components than those shown in fig. 3A and 3B. The fluid structure, being able to accommodate back pressure, pressure fluctuations, etc., enhances the performance, efficacy, and efficiency of the fluid handling device 100.

The example fluidic structure shown in fig. 3A includes channels that direct the flow of fluid between the reservoir 102 and the expandable member 104. In the example shown in fig. 3A, a first valve V1 in the first fluid channel controls the flow of fluid generated by the first pumping device P1 from the expandable member 104 to the reservoir 102. A second valve V2 in the second fluid channel controls the flow of fluid generated by the second pumping device P2 from the reservoir 102 to the expandable member 104. In the example shown in fig. 3A, a first pressure sensing device S1 senses fluid pressure at the reservoir 102 and a second pressure sensing device S2 senses fluid pressure at the expandable member 104. The first and second pressure sensing devices S1, S2 may provide monitoring of the fluid flow and/or the fluid pressure in the fluid channel. In the arrangement shown in fig. 3A, one of the first pump P1 or the second pump P2 is active, while the other of the first pump P1 or the second pump P2 is in a standby mode, such that the first and second pumps are not typically operated simultaneously. For example, operation of the first pump P1 (the second pump P2 being in the standby mode) may provide for the contraction of the expandable member 104, and operation of the second pump P2 (the first pump P1 being in the standby mode) may provide for the expansion of the expandable member 104. The valves V1, V2 may provide selective sealing of the respective fluid channels in order to maintain a set state of the fluid handling device. For example, selective sealing of the respective fluid channels by valves V1, V2 may maintain the expanded or contracted state of the expandable member 104. The interaction with the valves V1, V2 (and corresponding changes in fluid flow through the device's fluid structure) can change the set-up state of the fluid-operated device. Maintaining the set state of the device until the patient needs to change the set state of the device and initiating the desired change of the set state of the device, the valves V1, V2 provide enhanced patient safety and improved device efficacy.

In some examples, the valve and pump may be incorporated into a single component that provides both the generation of fluid flow and the control of fluid flow in the fluid-operated device. In some examples, the pump may be a multi-directional pump capable of pumping fluid in multiple directions. The exemplary fluidic structure shown in fig. 3B includes a hybrid pump and valve arrangement PV, or a combined pump and valve arrangement PV, that includes a multi-directional pumping arrangement and one or more valves that control fluid flow through the combined pump and valve arrangement PV. The pump and valve arrangement PV may pump fluid in a first direction (e.g., from the reservoir 102 toward the pump and valve arrangement PV, and the pump and valve arrangement PV toward the expandable member 104) and a second direction (e.g., from the expandable member 104 toward the pump and valve arrangement PV, and the pump and valve arrangement PV toward the reservoir 102). The combination of a hybrid pump or combined pump and valve arrangement PV may provide fluid pumping and flow control in a fluid handling device using fewer components in the fluid structure. In some examples, this may reduce the overall size of the fluid control system including the pump assembly, either of which may reduce power consumption, thereby increasing the life of the power storage device or battery of the fluid handling device 100.

In some examples, pumps P1, P2 and valves V1, V2 (and/or a hybrid pump or combined pump and valve device PV) included in the fluidic structure may each include chambers actuated by a diaphragm. For example, the pump may include a first check valve at an inlet port of the pump chamber and a second check valve at an outlet port of the pump chamber such that vibration of the diaphragm causes forward flow (i.e., flow from the inlet port toward the outlet port). Similarly, the valve may comprise a valve chamber, wherein actuation of the diaphragm causes a flow path between an inlet port and an outlet port of the valve chamber to close.

In some examples, the multi-directional pump and valve device may include a vibrating or oscillating diaphragm positioned between a first port and a second port of the fluid chamber, wherein the first electronically controlled valve is located at the first port and the second electronically controlled valve is located at the second port. The first and second valves may be opened and closed in a sequence that provides pumping in a first direction (i.e., from the first port toward the second port), pumping in a second direction (i.e., from the second port toward the first port), or closing of the fluid flow path. In some examples, two vibrating or oscillating diaphragms may be placed in series in a fluid flow path, for example, side-by-side or face-to-face in a fluid flow path. The first and second oscillating diaphragms act as diffusers in the flow path that sequentially restrict the flow of fluid through the flow path in a first direction and then in a second direction. Alternating restrictions of the order of flow through the flow path in the first direction and the second direction results in flow in either the first direction or the second direction, depending on the pattern created by the alternating restrictions of oscillation and flow of the first and second diaphragms.

In some examples, the valve included in the fluid-operated device's fluid structure may be a normally open valve. The use of a normally open valve may provide a failsafe measure in the operation of a fluid-operated device of the type described above, particularly if the fluid-operated device is electronically controlled. For example, failure of one of the valves within the fluid-operated device, and/or failure of the entire device to change state (e.g., a sustained expanded state of the expandable member and/or a failure to transition from an expanded state to a contracted state) may result in patient discomfort and may compromise patient safety. The use of a normally open valve and the corresponding normally open state of the valve will allow for release of pressure (e.g., contraction of the expandable member 104) and allow the fluid within the device to reach an equilibrium state, thereby providing comfort and safety to the patient.

In some examples, one or more valves included in the fluidic structure are piezoelectric valves, and in some examples are normally open piezoelectric valves. Piezoelectric materials produce electrical energy when mechanically deformed by strain. Conversely, piezoelectric materials deform in response to the application of an electric field. These characteristics allow for electronic control of the mechanical valve by applying a voltage to the valve.

In a normally open piezoelectric valve, the valve is in an open position in a passive or balanced state. The normally open valve closes in response to the application of a voltage. Fig. 4A shows an example of a normally open piezoelectric valve 400 in a balanced state, wherein the valve 400 is open. Fig. 4B shows the normally open piezoelectric valve 400 in a closed state. The example normally open piezoelectric valve 400 shown in fig. 4A and 4B includes a piezoelectric element 410 coupled to a valve base 450. Fluid ports 415, 425 are formed in the base 450. In the example shown in fig. 4A and 4B, the first fluid port 415 is an inlet port 415 and the second fluid port 425 is an outlet port. A fluid chamber 420 is defined in the space between the piezoelectric element 410 and the valve base 450.

As shown in fig. 4A, in the balanced state (i.e., the open state) of the normally-open piezoelectric valve 400, no voltage is applied to the piezoelectric element 410 of the valve 400. In the equilibrium state with the valve 400 open, the piezoelectric element 410 of the valve 400 deforms or deflects, allowing fluid to flow into the chamber 420 through the first port 415 and out of the chamber 420 through the second port 425. Applying a voltage to the piezoelectric element 410 of the valve 400 causes the valve 400 to close, as shown in fig. 4B. In some examples, the electrical bias may remain in the piezoelectric element 410 after the voltage is removed. The electrical bias built up in the piezoelectric element 410 of the valve may dissipate over time, thereby maintaining the closed state of the valve 400 for at least a portion of the dissipation cycle. In some examples, resistor 490 may be positioned in a circuit in parallel with piezoelectric element 410. Resistor 490 may provide controlled dissipation of the voltage built up in piezoelectric element 410 such that normally open valve 400 returns to the balanced/open state shown in fig. 4A in a time controlled manner.

In some examples, the voltage level applied to the valve 400 may be varied, for example, to vary the amount of opening of the valve 400, to vary the flow rate through the valve 400, and so forth. In some examples, variable voltage control may be applied to account for variations in barometric pressure (e.g., variations in altitude or depth) that affect the pressure of fluid flowing in the fluid handling device, and thus may affect proper operation of the fluid handling device. Fig. 5A shows a state of the valve 400 in which the fully open voltage Vo is applied to the piezoelectric element 410 of the valve 400 so that the valve 400 is in the fully open state. Fig. 5B shows a state of the valve 400 in which a partial opening voltage Vv or a variable voltage Vv is applied to the valve 400 such that the valve 400 is in a partial opening state. Fig. 5C shows a state of the valve 400 in which the full closing voltage Vc is applied to the valve 400 so that the valve 400 is in the full closing state. In the case where the valve 400 is the normally open piezoelectric valve 400 described above, the normal equilibrium state is the open state shown in fig. 5A, and therefore the fully open voltage Vo will be substantially zero.

In some examples, when the fluid-operated device experiences a change in atmospheric pressure and/or operating pressure (e.g., due to a change in altitude and/or depth), a corresponding change in fluid pressure and/or fluid flow rate through the valve 400 may be experienced. Without adjustment, these changes in fluid pressure and/or fluid flow rate may affect (adversely affect) proper operation of the fluid-operated device.

Fig. 6A shows the piezoelectric valve 400 in a state where the pressure PH in the chamber 420 and fluid passage is relatively high compared to the external pressure of the device (i.e., atmospheric pressure and/or operating pressure), thereby pulling the piezoelectric element 410 and diaphragm 430 away from the chamber 420 and increasing the flow rate through the valve 400. Fig. 6B shows the piezoelectric valve 400 in a state where the pressure PA in the chamber 420 and the fluid channel is substantially the same as the external pressure of the device. Fig. 6C shows the piezoelectric valve 400 in a state where the pressure PL in the chamber 420 and the fluid passage is significantly less than the external pressure of the device, thus pulling the piezoelectric element 410 and the diaphragm 430 towards the chamber 420, thereby closing the fluid passage and restricting the fluid flow through the valve 400.

As described above, the fluid-operated device may experience different levels of atmospheric pressure and/or operating pressure, which vary with, for example, altitude or depth. For example, the atmospheric pressure and/or the operating pressure decreases with increasing altitude, and thus a patient having an implanted fluid-operated device may experience a reduced atmospheric pressure and/or operating pressure while in flight. The reduced atmospheric pressure and/or operating pressure may affect the operation of the piezoelectric valve 400, as shown in fig. 6A. That is, a reduced atmospheric pressure and/or operating pressure may cause the baseline position of diaphragm 430 to change as shown, resulting in an increase in fluid flow rate through valve 400. Patients with implanted fluid handling devices may experience increased atmospheric pressure and/or working pressure when, for example, immersed in or swimming in water. The increased atmospheric pressure and/or operating pressure may affect the operation of the piezoelectric valve 400, as shown in fig. 6C. That is, increased atmospheric pressure and/or operating pressure may cause the baseline position of diaphragm 430 to change as shown, thereby causing a decrease in the fluid flow rate through valve 400 or restricting flow through valve 400. If the movement of diaphragm 430 is not corrected/recalibrated in response to changes in atmospheric pressure and/or operating pressure, either of these conditions may result in improper operation of the fluid operated device to the extent that patient comfort and safety may be compromised.

Electronically controlled fluid-operated devices have the ability to obtain atmospheric pressure and/or operating pressure in substantially real time. The electronically controlled fluid operation device may use the detected barometric pressure and/or operating pressure level, and the detected barometric pressure and/or operating pressure level changes, to adjust the pressure level in the fluid operation device, and in particular to adjust the operation of a flow control valve (e.g., the opening/closing level of a valve) in the fluid operation device, to ensure proper fluid pressure level and fluid flow rate for safe operation of the fluid operation device.

In some examples, a variable closing voltage may be applied to one or more valves 400 in a fluid-operated device to provide a corrected closing level of the valve 400 corresponding to a level of change in barometric pressure and/or operating pressure that the valve 400 may experience based on, for example, altitude or depth. In some examples, a calibration curve may be referenced to determine an appropriate closing voltage for a given barometric pressure and/or operating pressure sensed by an electronically controlled fluid-operated device. An exemplary calibration curve is shown in fig. 7. The exemplary calibration curve shown in fig. 7 illustrates the voltage required to close the fluid passage at different atmospheric and/or operating pressures for a particular valve.

In some examples, the calibration curve for each valve 400 of the fluid-operated device may be stored in the memory of the electronic control system 108, for example, in the form of a look-up table. During operation, when barometric pressure and/or operating pressure (and changes in barometric pressure and/or operating pressure) are sensed, electronic control system 108 may access the appropriate calibration curve/look-up table for each valve 400 and adjust the voltage level applied to each valve 400 accordingly to maintain the current state of the fluid handling device.

The ability to determine a variable closing voltage for each flow control valve within the fluid handling device to account for changing atmospheric conditions (e.g., when pressure varies with altitude and/or depth) and adjust the applied voltage accordingly to maintain the current state of the fluid handling device may provide proper operation of the fluid handling device even when subjected to changing atmospheric conditions. This may improve patient comfort and safety. The risk of overdriving the piezoelectric element and adversely affecting the overall device performance may be greatly reduced, particularly at high altitudes (low atmospheric pressure and/or operating pressure) where the pressure in the fluid passageway is relatively low. The ability to apply a regulated closing voltage (e.g., a lower closing voltage) may increase the reliability of the fluid operated device by reducing or substantially eliminating leakage problems in response to increased pressure levels in the fluid channel at depth and decreased pressure levels in the fluid channel at altitude. By applying a regulated voltage to the valve 400 under certain atmospheric conditions, improved and even optimal sealing may be achieved to provide an appropriate fluid flow volume and rate through the valve 400 and avoid damaging the valve 400. The proper sealing of the fluid passageway under varying atmospheric conditions provided by the use of a calibration curve to determine the proper closing voltage of the valve 400 may prevent over-pressurization of the inflatable member, reducing the risk of piezoelectric damage, thereby further improving patient safety and comfort.

In some examples, the fluid-operated device may include one or more normally-closed valves in fluid communication with the fluid-operated device. Normally closed valves may provide maximum sealing without activation (e.g., application of a voltage), which may be advantageous in some locations and in some circumstances within a fluid-operated device. Fig. 8A shows an exemplary normally closed valve 800 in a closed state. Fig. 8B shows an exemplary normally closed valve 800 in an open state.

The example normally-closed valve 800 illustrated in fig. 8A and 8B includes a plunger 870 movably positioned relative to the valve base 850 to selectively block a fluid passage 880 defined in the valve base 850. In the closed state shown in fig. 8A, the flange 872 of the plunger 870 is positioned against the sealing surface 852 of the valve base 850 with the O-ring 860 positioned in a sealing recess formed in the valve base 850. In some examples, an O-ring may be positioned in a seal recess formed in the flange 872 of the plunger 870. The piezoelectric element 810 is mounted on an outer foil 830 that is coupled to a valve base 850. The inner foil 840 is secured to the plunger 870 and the base 850.

In the closed state of the valve 800 shown in fig. 8A, the piezoelectric element 810 is not actuated (i.e., no voltage is applied) and the flange 872 of the plunger 870 is positioned against the sealing surface 852 of the valve base 850, thereby forming a seal that blocks the fluid channel 880. To change the state of the normally closed valve 800 from the closed state to the open state shown in fig. 8B, a voltage is applied to the piezoelectric element 810, resulting in deflection of the piezoelectric element 810, the outer foil 830, and the inner foil 840. In particular, application of a voltage to the piezoelectric element 810 has resulted in an upward deflection (in the exemplary orientation shown in fig. 8B) of the piezoelectric element 810 mounted on the outer foil 830, and a downward deflection of the inner foil 840 attached to the valve base 850 and plunger 870. This downward deflection of the inner foil 840 drives the plunger 870 downward with the inner foil 840. Deflection of the piezoelectric element 810 and the outer and inner foils 830, 840 and movement of the plunger 870 in this manner allows fluid to pass through the valve 800, as shown in fig. 8B. That is, in the open state shown in fig. 8B, the plunger 870 has moved downward away from the valve base 850 (in the exemplary orientations shown in fig. 8A and 8B) such that a space is formed between the flange 872 of the plunger 870 and the sealing surface 852 of the valve base 850. This movement releases the seal between plunger 870 and valve seat 850, thereby allowing fluid to flow into fluid channel 880 through at least one inlet 842 and out of fluid channel 880 through one or more outlets 844. In some examples, cyclical application and release of a voltage applied to the piezoelectric element 810 may produce a reciprocating motion of the plunger 870 as the plunger 870 alternates between the open position shown in fig. 8A and the closed position shown in fig. 8B.

In some cases, normally closed valve 800 may experience sudden fluctuations in fluid pressure due to, for example, falls, physical exertion, and the like. Sudden fluctuations or peaks in pressure may cause the plunger 870 to move, thereby causing leakage through the valve 800 when the valve 800 is forced from the closed position to the open position. As shown in fig. 8C, applying a back pressure at the outlet 844 of the normally closed valve 800 will cause the plunger 870 to engage against the valve seat 850, thereby increasing the sealing pressure in the valve 800. In the event of sudden fluctuations or peaks in fluid pressure in the valve 800, the increased sealing pressure will reduce the risk of leakage and will prevent undesirable changes in the state of the valve 800.

Figure 9 is a schematic illustration showing an exemplary fluid structure of a fluid handling device in the form of an inflatable penile prosthesis 100B as described above. In this exemplary arrangement, the inflatable cylinder 104B is in series with a normally closed valve 800. Thus, when pressure fluctuations or pressure spikes are experienced in the cylinder 104B, the pressure spikes may be utilized to apply back pressure to the normally closed valve 800, as described above. This may provide increased sealing pressure in the valve 800 during pressure spikes, thereby avoiding fluid leakage through the valve 800 and maintaining the desired state of the valve 800 and cylinder 104B.

Fig. 10A-10D illustrate a hybrid pump or combined pump and valve apparatus 900 as described above in which back pressure is applied in response to a detected pressure fluctuation or spike. The pump and valve device 900 includes a piezoelectric element 910 positioned on a diaphragm 930 along one side of a fluid chamber 920 of the pump and valve device 900. The first check valve 921 is positioned at a first end of the chamber 920, such as an inlet end of the chamber 920, corresponding to a first end portion of the piezoelectric element 910. The first check valve 921 regulates, for example, the flow of fluid into the chamber 920 in a first direction. A second check valve 922 is positioned at a second end of the chamber 920, such as an outlet end of the chamber 920, corresponding to a second end portion of the piezoelectric element 910. The second check valve 922 regulates, for example, the flow out of the chamber 920 in a second direction.

The supply stroke or upward stroke of the pump and valve device 900 (wherein the piezoelectric element 910 moves from the concave position shown in fig. 10A to the convex position shown in fig. 10B) and the corresponding pressure differential draw fluid into the chamber 920 through the first check valve 921 while the second check valve 922 remains closed. The pressure stroke or downward stroke of the pump and valve arrangement (including the contraction of the piezoelectric element 910 from the convex position shown in fig. 10B to the concave position shown in fig. 10C) closes the first check valve 921 and allows fluid to flow out of the chamber 920 through the second check valve 922. The pumping cycle may be repeated to continue pumping fluid into and out of the chamber 920 or through the chamber. In this arrangement, as shown in fig. 10D, the application of back pressure may provide a positive seal of the first and second check valves 921, 922 in the event of a spike or surge in fluid pressure that may otherwise cause an undesirable change in the state of the fluid handling device.

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

Claims (35)

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

a fluid reservoir;

an inflatable member;

a fluid control system configured to transfer fluid between the fluid reservoir and an expandable member, the fluid control system comprising:

a housing;

at least one pump positioned in a fluid passage within the housing;

a first fluid port in fluid communication with the fluid reservoir; and

a second fluid port in fluid communication with the expandable member;

at least one pressure sensing device configured to sense fluid pressure in the implantable fluid-operated inflatable device; and

an electronic control system configured to receive the pressure sensed by the at least one pressure sensing device and to control the at least one valve and at least one pump in response to the received pressure.

2. The implantable fluid-operated inflatable device of claim 1, wherein the at least one pump comprises a combined pump and valve device positioned in series between the reservoir and inflatable member, the combined pump and valve device comprising:

a chamber;

a diaphragm positioned along an edge portion of the chamber;

a piezoelectric element mounted on the diaphragm;

a first valve positioned at a first end portion of the chamber corresponding to a first end portion of the piezoelectric element; and

a second valve positioned at a second end portion of the chamber corresponding to a second end portion of the piezoelectric element.

3. The implantable fluid-operated inflatable device of claim 2, wherein,

in a first mode, fluid moves through the combined pump and valve device in a first direction to transfer fluid from the reservoir to the expandable member to expand the expandable member, a first pumping cycle of the combined pump and valve device comprising:

a first supply stroke in which fluid is drawn into the chamber through the first valve while the second valve is closed; and

a first pressure stroke in which fluid is discharged from the chamber through the second valve while the first valve is closed; and is also provided with

In a second mode, fluid is moved through the combined pump and valve device in a second direction to transfer fluid from the expandable member to the reservoir to collapse the expandable member, a second pumping cycle of the combined pump and valve device comprising:

a second supply stroke in which fluid is drawn into the chamber through the second valve while the first valve is closed; and

a second pressure stroke in which fluid is displaced out of the chamber through the first valve while the second valve is closed.

4. The implantable fluid-operated inflatable device of claim 3, wherein,

the first supply stroke and the first pressure stroke are alternately and repeatedly performed until an inflation pressure of the inflatable member is achieved based on the pressure sensed by the at least one sensing device; and is also provided with

The second supply stroke and the second pressure stroke are alternately and repeatedly performed until a systolic pressure is reached based on the pressure sensed by the at least one sensing device.

5. The implantable fluid-operated inflatable device of any one of claims 1-4, wherein the at least one pump is a piezoelectric pump and valve device comprising:

A valve base;

at least one inlet port formed in the valve base;

at least one outlet port formed in the valve base;

a diaphragm coupled to the valve base; and

a piezoelectric element mounted on the diaphragm,

wherein the voltage applied to the piezoelectric element is a variable voltage to maintain a set state of the fluid-operated inflatable device based on a pressure detected in the fluid passage of the valve relative to a detected pressure outside the valve.

6. The implantable fluid-operated inflatable device of claim 5, wherein the variable voltage applied to the piezoelectric element to maintain a set state of the fluid-operated inflatable device is based on a pressure detected in a fluid passageway of the valve relative to an atmospheric pressure sensed by the electronic control system.

7. The implantable fluid-operated inflatable device of claim 5 or 6, wherein a variable voltage applied to the piezoelectric element adjusts the position of the piezoelectric element and the diaphragm to adjust at least one of fluid pressure or fluid flow rate to adjust for atmospheric conditions and to correspond to a set state of the fluid-controlled inflatable device.

8. The implantable fluid-operated inflatable device according to any one of claims 5 to 7, wherein the voltage applied to the piezoelectric element is selected from a calibration curve associated with the piezoelectric valve, the calibration curve being accessible in a memory of the electronic control system.

9. The implantable fluid-operated inflatable device of any one of claims 5 to 8, wherein the pump and valve arrangement comprises a normally-open piezoelectric valve configured to transition from a normally-open state to a closed state in response to application of a voltage to the piezoelectric element and to return to the normally-open state in response to release of the voltage.

10. The implantable fluid-operated inflatable device according to any one of claims 5 to 9, wherein the normally-open piezoelectric valve is configured to remain in a closed state for a period of time after release of a voltage and transition to the normally-open state in response to dissipation of an electrical bias built up in the piezoelectric element.

11. The implantable fluid-operated inflatable device of any one of claims 5-10, the normally-open piezoelectric valve further comprising a resistor electrically connected to the piezoelectric element, wherein the resistor is configured to control dissipation of an electrical bias built up in the piezoelectric element such that the normally-open piezoelectric valve transitions from the closed state to the normally-open state within a set period of time after releasing the voltage.

12. The implantable fluid-operated inflatable device of claim 5, wherein the piezoelectric valve is a normally-closed piezoelectric valve configured to transition from a normally-closed state to an open state in response to application of a voltage to the piezoelectric element and to return to the normally-closed state in response to release of the voltage, the normally-closed piezoelectric valve comprising:

a plunger movably positioned within the fluid passage of the normally-closed piezoelectric valve, wherein the plunger seals against the valve seat in a normally-closed state so as to restrict flow through the fluid passage, and is spaced apart from the valve seat in an open state so as to open the fluid passage.

13. The implantable fluid-operated inflatable device of claim 12, wherein, in a normally closed state of the normally closed piezoelectric valve, a back pressure applied to the plunger through the at least one outlet maintains a sealed position of the plunger against the valve seat in response to fluctuations in fluid pressure at the at least one inlet.

14. The implantable fluid-operated inflatable device of any one of claims 1-13, wherein the electronic control system comprises a printed circuit board comprising a memory configured to store at least one control algorithm, a communication module configured to communicate with one or more external devices, and a processor configured to:

Receiving a pressure level measurement from the at least one sensing device;

applying the at least one control algorithm based on the received pressure level measurements; and is also provided with

The operation of the at least one valve and the at least one pump is controlled according to the at least one control algorithm applied.

15. The implantable fluid-operated 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. An implantable fluid-operated inflatable device, comprising:

a fluid reservoir;

an inflatable member;

a fluid control system configured to transfer fluid between the fluid reservoir and an expandable member, the fluid control system comprising:

a housing;

at least one valve and at least one pump positioned in a fluid passageway within the housing;

a first fluid port in fluid communication with the fluid reservoir; and

a second fluid port in fluid communication with the expandable member;

at least one pressure sensing device configured to sense fluid pressure in the implantable fluid-operated inflatable device; and

An electronic control system configured to receive the pressure sensed by the at least one pressure sensing device and to control the at least one valve and at least one pump in response to the received pressure.

17. The implantable fluid-operated inflatable device of claim 16, wherein the at least one valve and at least one pump comprise a combined pump and valve device positioned in series between the reservoir and inflatable member, the combined pump and valve device comprising:

a chamber;

a diaphragm positioned along an edge portion of the chamber;

a piezoelectric element mounted on the diaphragm;

a first valve positioned at a first end portion of the chamber corresponding to a first end portion of the piezoelectric element; and

a second valve positioned at a second end portion of the chamber corresponding to a second end portion of the piezoelectric element.

18. The implantable fluid-operated inflatable device of claim 17, wherein,

in a first mode, fluid moves through the combined pump and valve device in a first direction to transfer fluid from the reservoir to the expandable member to expand the expandable member, a first pumping cycle of the combined pump and valve device comprising:

A first supply stroke in which fluid is drawn into the chamber through the first valve while the second valve is closed; and

a first pressure stroke in which fluid is discharged from the chamber through the second valve while the first valve is closed; and is also provided with

In a second mode, fluid is moved through the combined pump and valve device in a second direction to transfer fluid from the expandable member to the reservoir to collapse the expandable member, a second pumping cycle of the combined pump and valve device comprising:

a second supply stroke in which fluid is drawn into the chamber through the second valve while the first valve is closed; and

a second pressure stroke in which fluid is displaced out of the chamber through the first valve while the second valve is closed.

19. The implantable fluid-operated inflatable device of claim 18, wherein,

the first supply stroke and the first pressure stroke are alternately and repeatedly performed until an inflation pressure of the inflatable member is achieved based on the pressure sensed by the at least one sensing device; and is also provided with

The second supply stroke and the second pressure stroke are alternately and repeatedly performed until a systolic pressure is achieved based on the pressure sensed by the at least one sensing device.

20. The implantable fluid-operated inflatable device of claim 16, wherein the at least one valve is a piezoelectric valve comprising:

a valve base;

at least one inlet port formed in the valve base;

at least one outlet port formed in the valve base;

a diaphragm coupled to the valve base; and

a piezoelectric element mounted on the diaphragm,

wherein the voltage applied to the piezoelectric element is a variable voltage to maintain a set state of the fluid-operated inflatable device based on a pressure detected in the fluid passage of the valve relative to a detected pressure outside the valve.

21. The implantable fluid-operated inflatable device of claim 20, wherein the variable voltage applied to the piezoelectric element to maintain a set state of the fluid-operated inflatable device is based on a pressure detected in a fluid passageway of the valve relative to an atmospheric pressure sensed by the electronic control system.

22. The implantable fluid-operated inflatable device of claim 21, wherein a variable voltage applied to the piezoelectric element adjusts the position of the piezoelectric element and the diaphragm to adjust at least one of fluid pressure or fluid flow rate to adjust for atmospheric conditions and to correspond to a set state of the fluid-controlled inflatable device.

23. The implantable fluid-operated inflatable device of claim 20, wherein the voltage applied to the piezoelectric element is selected from a calibration curve associated with the piezoelectric valve, the calibration curve being accessible in a memory of the electronic control system.

24. The implantable fluid-operated inflatable device of claim 20, wherein the at least one valve is a normally-open piezoelectric valve configured to transition from a normally-open state to a closed state in response to application of a voltage to the piezoelectric element and to return to the normally-open state in response to release of the voltage.

25. The implantable fluid-operated inflatable device of claim 24, wherein the normally-open piezoelectric valve is configured to remain in a closed state for a period of time after releasing a voltage and transition to the normally-open state in response to dissipation of an accumulated electrical bias in the piezoelectric element.

26. The implantable fluid-operated inflatable device of claim 24, the normally-open piezoelectric valve further comprising a resistor electrically connected to the piezoelectric element, wherein the resistor is configured to control dissipation of an electrical bias built up in the piezoelectric element such that the normally-open piezoelectric valve transitions from the closed state to the normally-open state within a set period of time after releasing the voltage.

27. The implantable fluid-operated inflatable device of claim 20, wherein the piezoelectric valve is a normally-closed piezoelectric valve configured to transition from a normally-closed state to an open state in response to application of a voltage to the piezoelectric element and to return to the normally-closed state in response to release of the voltage, the normally-closed piezoelectric valve comprising:

a plunger movably positioned within a fluid passage of the normally-closed piezoelectric valve, wherein the plunger seals against the valve seat in a normally-closed state so as to restrict flow through the fluid passage, and is spaced apart from the valve seat in an open state so as to open the fluid passage.

28. The implantable fluid-operated inflatable device of claim 27, wherein, in a normally closed state of the normally closed piezoelectric valve, a back pressure applied to the plunger through the at least one outlet maintains a sealed position of the plunger against the valve seat in response to fluctuations in fluid pressure at the at least one inlet.

29. The implantable fluid-operated inflatable device of claim 16, wherein the electronic control system comprises a printed circuit board comprising a memory configured to store at least one control algorithm, a communication module configured to communicate with one or more external devices, and a processor configured to:

Receiving a pressure level measurement from the at least one sensing device;

applying the at least one control algorithm based on the received pressure level measurements; and is also provided with

The operation of the at least one valve and the at least one pump is controlled according to the at least one control algorithm applied.

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

31. A method of controlling an implantable fluid-operated inflatable device, comprising:

receiving, by a processor of the inflatable device, a fluid pressure measurement from a pressure sensing device within a fluid passageway of the inflatable device;

comparing, by the processor, the measured pressure received from the pressure sensing device with a pressure external to the fluid channel; and is also provided with

And applying, by the processor, a voltage to a piezoelectric element of a piezoelectric valve of the inflatable device based on the comparison control circuit to maintain a set state of the inflatable device.

32. The method of claim 31, wherein controlling circuitry to apply a voltage to the piezoelectric element comprises:

Based on the comparison, detecting a change in atmospheric pressure from a calibration condition of the inflatable device based on the comparison;

selecting, by the processor, a voltage to be applied to a piezoelectric element of a piezoelectric valve of an inflatable device from a previously stored look-up table in response to a detected change in atmospheric pressure; and is also provided with

A selected voltage is applied to the piezoelectric element to maintain a set condition of the inflatable device under varying atmospheric conditions.

33. The method of claim 31, wherein the piezoelectric valve is a normally open piezoelectric valve, and wherein controlling a circuit to apply a voltage to the piezoelectric element comprises controlling a resistor in the circuit such that an electrical bias built up in the piezoelectric element dissipates over a set period of time to return the normally open piezoelectric valve to a normally open state.

34. The method of claim 31, wherein the piezoelectric valve is a normally closed piezoelectric valve, the method further comprising:

detecting fluctuations in fluid pressure at an inlet portion of the piezoelectric valve; and is also provided with

A back pressure is applied at an outlet portion of the piezoelectric valve in response to fluctuations in fluid pressure at the inlet portion, thereby maintaining a closed state of the normally closed piezoelectric valve.

35. The method of claim 31, further comprising:

receiving, by a control module of the processor, user input from an external device in communication with the processor; and is also provided with

At least one of a fluid pressure or a fluid flow rate in the inflatable device is adjusted in response to the received user input.