Electronic pump assembly and pressure control for an implantable device - Patents.com

Abstract

According to one aspect, an implantable device includes a pressurized fluid reservoir configured to hold a fluid, an expandable member, and an electronic pump assembly including a pump, an active valve, a pressure sensor configured to monitor pressure in the expandable member, and a controller configured to transition the active valve to an open position during at least a portion of an inflation cycle to allow fluid to be transferred from the pressurized fluid reservoir to the expandable member. The controller is configured to transition the active valve to a closed position in response to pressure in the expandable member achieving a target pressure.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of and claims priority to U.S. Nonprovisional Patent Application No. 18 / 172,933, entitled “ELECTRONIC PUMP ASSEMBLY AND PRESSURE CONTROL FOR AN IMPLANTABLE DEVICE,” filed February 22, 2023, which claims priority to U.S. Provisional Patent Application No. 63 / 268,644, entitled “ELECTRONIC PUMP ASSEMBLY AND PRESSURE CONTROL FOR AN IMPLANTABLE DEVICE,” filed February 28, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 268,644, filed February 28, 2022, the disclosure of which is incorporated by reference in its entirety herein.

[0003] SUMMARY This disclosure relates generally to implantable devices having electronic pump assemblies capable of controlling and regulating pressure within an expandable member. [Background technology]

[0004] The implantable device may include a pressurized reservoir that can transfer fluid to the expandable member. In some cases, a patient may require a revision surgery to adjust the implantable member if a lower (or higher) pressure is required in the expandable member. Summary of the Invention [Means for solving the problem]

[0005] According to one aspect, an implantable device includes a pressurized fluid reservoir configured to hold a fluid, an expandable member, and an electronic pump assembly including a pump, an active valve, a pressure sensor configured to monitor pressure in the expandable member, and a controller configured to transition the active valve to an open position during at least a portion of an inflation cycle to allow fluid to be transferred from the pressurized fluid reservoir to the expandable member. The controller is configured to transition the active valve to a closed position in response to pressure in the expandable member achieving a target pressure.

[0006] The implantable device may include one or more (or any combination thereof) of the following features: The controller is configured to operate the pump during a deflation cycle to transfer fluid from the inflatable member to the pressurized fluid reservoir. The electronic pump assembly includes an antenna configured to receive a wireless control signal from an external device, and the controller is configured to initiate an inflation cycle or a deflation cycle based on the wireless control signal. Fluid is transferred from the pressurized fluid reservoir to the inflatable member during an inflation cycle without the use of a pump. The active valve is disposed in parallel with the pump. The controller is configured to control the pump to operate to transfer a portion of fluid from the inflatable member to the pressurized fluid reservoir in response to the pressure in the inflatable member being greater than a target pressure. The controller is configured to transition the active valve from an open position to a partially open position in response to the pressure exceeding a threshold level, the pressure being a value less than the target pressure. The electronic pump assembly may include a first pressure sensor for monitoring the pressure in the inflatable member and a second pressure sensor configured to monitor the pressure in the pressurized fluid reservoir. The controller is configured to place the active valve in an open position for a period of time in response to pressure in the pressurized fluid reservoir exceeding a threshold level. The controller is configured to detect a patient position of the implantable device based on pressure readings from at least one of the first pressure sensor or the second pressure sensor, and the controller is configured to adjust the pressure of the expandable member based on the detected position.

[0007] According to one aspect, the implantable device includes a pressurized fluid reservoir configured to hold a fluid, an expandable member, and an electronic pump assembly including a pump, an active valve, a pressure sensor configured to monitor the pressure in the expandable member, and a controller configured such that the active valve is in an open position during at least a portion of an inflation cycle until the pressure in the expandable member achieves a target pressure.

[0008] The implantable device may include one or more (or any combination thereof) of the above / below features. The controller is configured to actuate the pump during a deflation cycle to transfer fluid from the inflatable member to the pressurized fluid reservoir. The electronic pump assembly includes an antenna configured to receive a wireless control signal from an external device, and the controller is configured to initiate an inflation cycle or a deflation cycle based on the wireless control signal. The active valve is disposed in parallel with the pump. The controller is configured to control the pump to actuate to transfer a portion of fluid from the inflatable member to the pressurized fluid reservoir in response to the pressure in the inflatable member being higher than a target pressure. The controller is configured to transition the active valve from an open position to a partially open position in response to the pressure exceeding a threshold level, the threshold level being a value lower than the target pressure. The pressure sensor is a first pressure sensor, and the electronic pump assembly includes a second pressure sensor configured to monitor the pressure in the pressurized fluid reservoir. The controller is configured to place the active valve in an open position for a period of time in response to the pressure in the pressurized fluid reservoir exceeding a threshold level.

[0009] According to one aspect, a method of operating an implantable device includes receiving, by an antenna of an electronic pump assembly, a wireless control signal from an external device, generating, by a controller, a first control signal for controlling an active valve of the electronic pump assembly in response to the wireless control signal, and actuating, in response to the first control signal, the active valve to an open position to transfer fluid from a pressurized fluid reservoir to the expandable member until pressure in the expandable member reaches a threshold level. In some examples, the method includes generating, by the controller, a second control signal for controlling a pump of the electronic pump assembly, and actuating, in response to the second control signal, the pump to transfer fluid from the expandable member to the pressurized fluid reservoir. In some examples, the method includes detecting, by the controller, that the pressure in the expandable member exceeds a threshold level, and the second control signal is generated in response to the pressure in the expandable member being detected as exceeding the threshold level. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 illustrates an implantable device according to one embodiment. [Diagram 2] FIG. 1 illustrates an implantable device according to another embodiment. [Diagram 3] FIG. 1 illustrates an implantable device according to another embodiment. [Figure 4] FIG. 1 illustrates an implantable device according to another embodiment. [Diagram 5] 1 is a flow diagram illustrating an example operation for controlling an implantable device according to one aspect. [Figure 6] FIG. 1 illustrates a urethral control device according to one embodiment. [Figure 7] FIG. 1 illustrates an inflatable penile prosthesis according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The implantable device (e.g., artificial urinary sphincter device, inflatable penile prosthesis) can include a fluid reservoir, an inflatable member (e.g., an inflatable cuff member, an inflatable cylinder), and an electronic pump assembly configured to control pressure within the inflatable member. The electronic pump assembly can include a controller, one or more active valves, one or more pumps, and one or more pressure sensors. The electronic pump assembly can include a circuit board, a battery, and a communication module for controlling the implantable device to deliver the appropriate pressure to the inflatable member.

[0012] The pressure in the expandable member can be generated by a fluid reservoir (e.g., a pressurized reservoir). In some examples, a pressure differential between the pressurized reservoir and the expandable member will cause fluid to flow from the pressurized reservoir to the expandable member, thereby transferring fluid from the fluid reservoir to the expandable member without the use of a pump.

[0013] Without electronic implementation, the pressure in the expandable member may equilibrate with the pressurized reservoir. However, for the system to be adjustable, the pressure in the pressurized reservoir may be required to be at least equal to (or greater than) the desired pressure in the expandable member. The electronic pump assembly is configured to sense and control the pressure in the expandable member.

[0014] To inflate the expandable member, a controller of the electronic pump assembly can transition the active valve to an open position (fluid can flow through the active valve). For example, when the active valve is in the open position, fluid will flow to the expandable member as a result of pressure in the fluid reservoir. The controller can receive pressure readings from a pressure sensor configured to monitor the pressure in the expandable member. Using the pressure readings, the controller can determine that the pressure in the expandable member has reached a target (or desired pressure) and can transition the active valve to a closed position (fluid is prevented from flowing through the active valve) so that the pressure in the expandable member can be maintained.

[0015] After the active valve is closed, the controller may determine that the pressure in the expandable member is higher than the target pressure. For example, the pressure in the expandable member may be higher than the target pressure as a result of the time required to process the pressure readings, generate instructions, and close the active valve. In some examples, the controller may operate the pump to pump a small amount of fluid from the expandable member to the fluid reservoir so that the pressure in the expandable member can achieve the target pressure. In some examples, the controller may determine an overshoot pressure (e.g., the difference between the pressure in the expandable member now and the target pressure) and control the pumping speed of the pump based on that amount. For example, if the overshoot pressure is higher than a threshold amount, the controller may cause the pump to pump the fluid at a first rate (e.g., a higher rate). If the overshoot pressure is lower than the threshold amount, the controller may cause the pump to pump the fluid at a second rate (e.g., a lower rate).

[0016] In some examples, the active valve is a variable control valve. When a high pressure difference exists between the target pressure and the actual pressure, the controller can control the active valve to be fully open. Upon detecting that the actual pressure in the inflatable member is close to the target pressure, the controller can control the active valve to a partially open position so that the rate at which fluid is delivered to the inflatable member can be reduced, thereby preventing or reducing an overpressure event. Similarly, partially closing the active valve can reduce the time it takes to fully close the active valve, thereby reducing the system response time.

[0017] In some examples, the implantable device includes a pressure sensor configured to monitor the pressure of the fluid reservoir. For example, during certain activities involving the patient (and the patient's posture), the pressure in the fluid reservoir may change. For example, during periods of vigorous activity (e.g., vigorous exercise) or when the patient coughs, intra-abdominal pressure may increase, which may cause the patient to become incontinent. This pressure spike may be transmitted to the fluid reservoir. In some examples, when a pressure reading from the pressure sensor monitoring the pressure of the fluid reservoir is higher than a threshold level, the controller may transition the active valve to an open position such that some fluid is transferred to the inflatable member to prevent incontinence caused by the increased intra-abdominal pressure.

[0018] In some examples, posture may affect intra-abdominal pressure, with a standing position generating higher pressure than a lying position. In some examples, the controller is configured to detect a patient posture based on pressure readings from a first pressure sensor monitoring the pressure of the fluid reservoir and / or a pressure reading from a pressure sensor monitoring the pressure of the inflatable member. In some examples, when the detected patient posture is a posture in which the patient is lying, the controller may reduce the pressure in the inflatable member by activating a pump to transfer a portion of the fluid from the inflatable member to the fluid reservoir. When the detected patient posture is a posture in which the patient is standing, the controller may increase the pressure in the inflatable member by transitioning the active valve to an open position. In some examples, the controller may detect a change in posture (e.g., from lying to standing) based on the pressure readings, and the controller may adjust the pressure in the inflatable member in response to the change in posture. These and other features are described in further detail with reference to the figures.

[0019] 1 illustrates an implantable device 100 according to one embodiment. In some examples, the implantable device 100 is an artificial urinary sphincter device. In some examples, the implantable device 100 is an inflatable penile prosthesis. However, the implantable device 100 can include any type of medical device that transfers fluid between components of the implantable device 100.

[0020] The implantable device 100 includes a fluid reservoir 102, an inflatable member 104, and an electronic pump assembly 106 configured to transfer fluid between the fluid reservoir 102 and the inflatable member 104. In some examples, the inflatable member 104 is an inflatable cuff member configured to be implemented around the patient's urethra. In some examples, the inflatable member 104 is a penile expansion member (e.g., one or more inflatable cylinders) that can be implanted within the user's corpus cavernosum. The fluid reservoir 102 can be implanted within the user's abdominal or pelvic cavity (e.g., the fluid reservoir 102 can be implanted in a lower portion of the user's abdominal cavity or an upper portion of the user's pelvic cavity). In some examples, at least a portion of the electronic pump assembly 106 can be implemented in the patient's body.

[0021] The expandable member 104 may have the ability to expand upon injection of fluid into the cavity of the expandable member 104. When implanted around the urethra, the expansion of the expandable member 104 results in the urethra becoming constricted, thereby reducing the risk of incontinence for the patient. For example, the electronic pump assembly 106 is configured to pressurize the inflatable cuff (e.g., the expandable member 104) to constrict the urethra, thereby inhibiting urine flow. To urinate, the patient may activate the electronic pump assembly 106 to depressurize the inflatable cuff by transferring fluid from the inflatable cuff to the fluid reservoir 102. When implanted within the corpus cavernosum, upon injection of fluid into the expandable member 104, the expandable member 104 may increase its length and / or width as well as increase its stiffness.

[0022] The fluid reservoir 102 may include a container having an internal chamber configured to hold or store a fluid used to inflate the expandable member 104. In some examples, the fluid reservoir 102 is pressurized. In some examples, the fluid reservoir 102 is a pressurized balloon. In some examples, the implantable device 100 includes a single pressurized balloon. In some examples, the implantable device 100 includes two or more pressurized balloons. The pressure in the expandable member 104 may be generated by the fluid reservoir 102. For example, the fluid may be transferred to the expandable member 104 without the use of a pump. The pressure difference between the expandable member 104 and the fluid reservoir 102 will cause the fluid to flow from the fluid reservoir 102 to the expandable member 104. In some examples, the pressure in the fluid reservoir 102 is higher than the pressure in the expandable member 104 (e.g., even when the expandable member 104 is at a target pressure or maximum pressure). In some examples, the pressure in the fluid reservoir 102 is always greater than the pressure in the expandable member 104 .

[0023] The volume capacity of the fluid reservoir 102 may vary depending on the size of the implantable device 100. In some examples, the volume capacity of the fluid reservoir 102 may be between 3 cubic centimeters and 150 cubic centimeters. In some examples, the fluid reservoir 102 is composed of the same material as the expandable member 104. In other examples, the fluid reservoir 102 is composed of a different material than the expandable member 104. In some examples, the fluid reservoir 102 contains a larger volume of fluid than the expandable member 104.

[0024] The implantable device 100 may include a first conduit connector 103 and a second conduit connector 105. The first conduit connector 103 and the second conduit connector 105 may each define a lumen configured to transfer fluid to and from the electronic pump assembly 106. The first conduit connector 103 may be coupled to the electronic pump assembly 106 and the fluid reservoir 102 such that fluid may be transferred therethrough between the electronic pump assembly 106 and the fluid reservoir 102. For example, the first conduit connector 103 may define a first lumen configured to transfer fluid between the electronic pump assembly 106 and the fluid reservoir 102. The first conduit connector 103 may include a single or multiple tubing members for transferring fluid between the electronic pump assembly 106 and the fluid reservoir 102.

[0025] The second conduit connector 105 can be coupled to the electronic pump assembly 106 and the expandable member 104 such that fluid can be transferred therethrough between the electronic pump assembly 106 and the expandable member 104. For example, the second conduit connector 105 can define a second lumen configured to transfer fluid between the electronic pump assembly 106 and the expandable member 104. The second conduit connector 105 can include a single or multiple tubing members for transferring fluid between the electronic pump assembly 106 and the expandable member 104. In some examples, the first conduit connector 103 and the second conduit connector 105 can include a silicone rubber material. In some examples, the electronic pump assembly 106 can be directly connected to the fluid reservoir 102.

[0026] The electronic pump assembly 106 can monitor, control, and regulate the pressure in the expandable member 104. The electronic pump assembly 106 can automatically transfer fluid between the fluid reservoir 102 and the expandable member 104 without a user manually activating the pump (e.g., squeezing and releasing a pump bulb). The electronic pump assembly 106 can include a pump 120 (or multiple pumps 120), an active valve 118 (or multiple active valves 118), and a pressure sensor 130. In some examples, the pressure sensor 130 is configured to monitor the pressure of the fluid reservoir 102. In some examples, the electronic pump assembly 106 includes a pressure sensor 131 configured to monitor the pressure of the fluid reservoir 102. The controller 114 can control the pump 120 to pump fluid from the expandable member 104 to the fluid reservoir 102, and control the active valve 118 to transition between an open position and a closed position. In some examples, the controller 114 can control the active valve 118 to be in an intermediate position (e.g., between the open and closed positions) in which the active valve 118 has a partially open state that allows fluid to flow through the active valve 118 only at a rate lower than the rate in the open position.

[0027] The electronic pump assembly 106 can include a battery 116 configured to power the controller 114 and other components on the electronic pump assembly 106. In some examples, the battery 116 is a non-rechargeable battery. In some examples, the battery 116 is a rechargeable battery. In some examples, the electronic pump assembly 106 (or a portion thereof) (or the controller 114) is configured to be connected to an external charger to charge the battery 116. In some examples, the electronic pump assembly 106 can define a charging interface configured to connect to the external charger. In some examples, the charging interface includes a Universal Serial Bus (USB) interface configured to accept a USB charger. In some examples, the charging technology can be electromagnetic or piezoelectric.

[0028] The electronic pump assembly 106 can include an antenna 112 configured to wirelessly transmit (and receive) a radio signal 109 to (and from) the external device 101. The external device 101 can be any type of component capable of communicating with the electronic pump assembly 106. The external device 101 can be a computer, a smart phone, a tablet, a pendant, a key fob, etc. A user can control the implantable device 100 using the external device 101. In some examples, a user can use the external device 101 to inflate or deflate the expandable member 104.

[0029] For example, in response to a user initiating an inflation cycle with the external device 101 (e.g., selecting a user controller on the external device 101), the external device 101 can transmit a wireless signal 109 to the electronic pump assembly 106 (received through the antenna 112) to initiate the inflation cycle, and the controller 114 can control the active valve 118 to an open position, thereby allowing the transfer of fluid from the fluid reservoir 102 to the expandable member 104 until a target pressure in the expandable member 104 is achieved. For example, the controller 114 can receive pressure readings from the pressure sensor 130 and control the active valve 118 to a closed position when the pressure in the expandable member 104 has reached (or exceeded) the target pressure, thereby maintaining pressure in the expandable member 104.

[0030] In some examples, in response to a user initiating a deflation cycle with the external device 101 (e.g., selecting a user controller on the external device 101), the external device 101 can transmit a wireless signal 109 to the electronic pump assembly 106 (received through the antenna 112) to initiate a deflation cycle, and the controller 114 can control the pump 120 to pump fluid from the expandable member 104 to the fluid reservoir 102. In some examples, during a deflation cycle, the active valve 118 can remain in a closed state. The controller 114 can control the pump 120 to continue pumping fluid from the expandable member 104 to the fluid reservoir 102 until the pressure in the expandable member 104 reaches a lower threshold (e.g., zero pounds per square inch (PSI)). For example, the controller 114 can receive pressure readings from the pressure sensor 130, and in response to detecting that the pressure within the expandable member 104 has reached a lower threshold, the controller 114 can control the pump 120 to go to a stopped state (e.g., to stop pumping).

[0031] The controller 114 can be any type of controller configured to control the operation of the pump 120 and the active valve 118. In some examples, the controller 114 is a microcontroller. In some examples, the controller 114 includes one or more drivers configured to drive the pump 120 and the active valve 118. In some examples, the drivers are separate components from the controller 114. The controller 114 can be communicatively coupled to the active valve 118, the pump 120, the pressure sensor 130, and the pressure sensor 131. In some examples, the controller 114 is connected to the active valve 118, the pump 120, the pressure sensor 130, and the pressure sensor 131 through wired data lines. The controller 114 can include a processor 113 and a memory device 115. The processor 113 can be formed in a substrate configured to execute one or more machine executable instructions or some software, firmware, or a combination thereof. The processor 113 may be semiconductor based, i.e., the processor may include semiconductor materials capable of executing digital logic. The memory device 115 may store information in a format that may be read and / or executed by the processor 113. The memory device 115 may store executable instructions that, when executed by the processor 113, cause the processor 113 to perform certain operations discussed herein. The controller 114 may receive data through the pressure sensor 130, the pressure sensor 131, and / or the external device 101 and control the active valve 118 and / or the pump 120 by sending control signals to the active valve 118 and / or the pump 120.

[0032] The memory device 115 can store control parameters that a user and / or physician can set or modify by using the external device 101. In some examples, the control parameters can include a target inflation pressure (e.g., target pressure) and / or a partial inflation pressure. In some examples, the target pressure is the highest (or desired) pressure allowable in the expandable member 104. In some examples, the partial inflation pressure is a pressure threshold at which the expandable member 104 is deflated. In some examples, the partial inflation pressure is zero PSI. In some examples, the partial inflation pressure is a value higher than zero PSI but lower than the target inflation pressure. A user or physician can update the control parameters using the external device 101, which can be communicated to the controller 114 through the antenna 112 and then updated in the memory device 115.

[0033] The external device 101 can communicate with the electronic pump assembly 106 over a network. In some examples, the network can include a short-range wireless network, such as Near Field Communication (NFC), Bluetooth, or infrared communication. In some examples, the network can include the Internet (e.g., Wi-Fi) and / or other types of data networks, such as a local area network (LAN), a wide area network (WAN), a cellular network, a satellite network, or other types of data networks.

[0034] In some examples, the electronic pump assembly 106 includes a single pump 120. The pump 120 can be disposed in parallel with the active valve 118. In some examples, the electronic pump assembly 106 includes multiple pumps 120. In some examples, one or more pumps 120 can be disposed in parallel with one another (e.g., parallel pumps). In some examples, one or more pumps 120 can be disposed in series with one another. In some examples, the electronic pump assembly 106 includes one or more parallel pumps, one or more series pumps, or a combination of parallel and series pumps. In some examples, the pump 120 is disposed in a fluid passageway 125 used to empty the inflatable member 104 (e.g., during a deflation cycle).

[0035] The pump 120 is an electronically controlled pump. The pump 120 can be electronically controlled by the controller 114. For example, the pump 120 can be connected to the controller 114 and can receive a signal to operate the pump 120. The pump 120 can be unidirectional, in which the pump 120 can transfer fluid from the expandable member 104 to the fluid reservoir 102. In some examples, the pump 120 can be bidirectional, in which the pump 120 can transfer fluid from the fluid reservoir 102 to the expandable member 104 and from the expandable member 104 to the fluid reservoir 102.

[0036] In some examples, the pump 120 is an electromagnetic pump that uses electromagnetism to move fluid from the expandable member 104 to the fluid reservoir 102. For an electromagnetic pump, a magnetic field is set at an angle to the direction of fluid movement and an electric current is applied thereto.

[0037] In some examples, the pump 120 is a piezoelectric pump. In some examples, the piezoelectric pump can be a diaphragm micropump that uses actuation of a diaphragm to drive fluid. In some examples, the piezoelectric pump can include one or more piezoelectric pumps (e.g., piezoelectric elements) that can be implemented with a substrate layer of high-voltage piezoelectric elements (e.g., a single substrate layer) or multiple substrate layers of low-voltage piezoelectric elements (e.g., stacked substrate layers). In some examples, the pump 120 includes multiple micropumps (e.g., piezoelectrically driven micropumps) disposed on one or more substrates (e.g., wafers). In some examples, the micropump includes a silicon-based material. In some examples, the micropump includes a metal (e.g., steel)-based material. In some examples, the pump 120 is non-mechanical (e.g., has no moving parts).

[0038] The active valve 118 can be an electronically controlled valve. The active valve 118 can be electronically controlled by the controller 114. In some examples, the active valve 118 is a piezoelectric valve. In some examples, the active valve 118 is a piezoelectric diaphragm valve. The active valve 118 can be connected to the controller 114 and can receive a signal to transition the active valve 118 between an open position and a closed position. In some examples, the active valve 118 can be actuated to an intermediate position between the open position and the closed position where the active valve 118 is partially open. When the active valve 118 is in a partially open position, fluid flows through the valve at a rate lower than the fluid transfer rate of a fully open valve.

[0039] In some examples, the active valve 118 is disposed in a fluid passage 124 that is used to fill (e.g., in an inflation cycle) the expandable member 104. In some examples, the active valve 118 can be transitioned to a closed position to retain (e.g., substantially retain) pressure within the expandable member 104. In some examples, the active valve 118 can be transitioned to an open position to transfer fluid back to the expandable member 104.

[0040] In some examples, the electronic pump assembly 106 includes a single active valve 118. In some examples, the electronic pump assembly 106 includes multiple active valves 118. In some examples, one or more additional active valves 118 can be in series with the pump 120. In some examples, the additional active valves 118 (e.g., the series active valves 118) can be disposed in the fluid path portion 117 connected to the fluid reservoir 102. In some examples, the additional active valves 118 (e.g., the series active valves 118) can be disposed in the fluid path portion 119 connected to the expandable member 104. These additional active valves 118 can reduce leakage when at the target pressure.

[0041] The pressure sensor 130 and the pressure sensor 131 are communicatively coupled to the controller 114 such that the controller 114 can receive a signal (e.g., a pressure reading) from the pressure sensor 130. In some examples, as shown in FIG. 1 , the pressure sensor 130 is disposed between the pump 120 and the expandable member 104. In some examples, the pressure sensor 131 is disposed between the pump 120 and the fluid reservoir 102. The pressure sensor 130 can measure the pressure in the expandable member 104, and in some examples, the pressure sensor 131 can measure the pressure in the fluid reservoir 102. In some examples, the electronic pump assembly 106 may include additional pressure sensors that can be positioned at various locations within the electronic pump assembly 106.

[0042] The controller 114 can receive the measured pressure from the pressure sensor 130 and / or the pressure sensor 131 and automatically control the active valve 118 and / or the pump 120 to adjust the pressure. In some examples, after the active valve 118 is closed (at the end of the inflation cycle), the controller 114 may determine that the pressure in the expandable member 104 is higher than the target pressure. For example, the pressure in the expandable member 104 may be higher than the target pressure as a result of the time required to process the pressure readings, generate commands, and close the active valve 118. In some examples, the controller 114 can operate the pump 120 to transfer a small amount of fluid from the expandable member 104 to the fluid reservoir 102 so that the pressure in the expandable member 104 can achieve the target pressure.

[0043] In some examples, the controller 114 can determine an overshoot pressure (e.g., the difference between the pressure currently in the expandable member 104 and the target pressure) and control the pumping rate of the pump 120 based on that amount. For example, if the overshoot pressure is higher than a threshold amount, the controller 114 can cause the pump 120 to deliver fluid at a first rate (e.g., a higher rate). If the overshoot pressure is lower than the threshold amount, the controller 114 can cause the pump to deliver fluid at a second rate (e.g., a lower rate). In some examples, the second rate is lower than the first rate.

[0044] In some examples, the active valve 118 is a variable control valve. When a high pressure difference exists between the target pressure and the actual pressure, the controller 114 can control the active valve 118 to be fully open. When the controller 114 detects that the actual pressure in the expandable member 104 is near the target pressure (e.g., exceeds a threshold level below the target pressure), the controller 114 can control the active valve 118 to a partially open position such that the rate at which fluid is delivered to the expandable member 104 is reduced, thereby preventing or reducing an overpressure event. Additionally, by partially closing the active valve 118, the time it takes to fully close the active valve 118 can be reduced, thereby reducing the response time of the system.

[0045] In some examples, during certain activities involving the patient (and the patient's posture), the pressure in the fluid reservoir 102 may change. For example, during periods of vigorous activity (e.g., vigorous exercise) or when the patient coughs, intra-abdominal pressure may increase, which may cause the patient to become incontinent. This pressure spike may be transmitted to the fluid reservoir 102. In some examples, when the pressure reading from the pressure sensor 131 is higher than a threshold level, the controller 114 may transition the active valve 118 to an open position such that some fluid is transferred to the expandable member 104 to prevent incontinence caused by the increased intra-abdominal pressure.

[0046] In some examples, posture may affect intra-abdominal pressure, with a standing position generating higher pressure than a lying position. In some examples, the controller 114 is configured to detect the patient's posture based on pressure readings from the pressure sensor 130 and / or pressure readings from the pressure sensor 131. In some examples, the electronic pump assembly 106 includes an accelerometer (e.g., a single-axis or multi-axis accelerometer) configured to communicate with the controller 114. The accelerometer may detect the acceleration and / or orientation of the patient's body. The controller 114 may detect the patient's posture or orientation using the readings from the accelerometer.

[0047] In some examples, if the detected patient position is a position in which the patient is lying down (e.g., a first position), the controller 114 can reduce the pressure in the expandable member 104 by activating the pump 120 to transfer a portion of fluid from the expandable member 104 to the fluid reservoir 102. If the detected patient position is a position in which the patient is standing (e.g., a second position), the controller 114 can increase the pressure in the expandable member 104 by transitioning the active valve 118 to an open position. In some examples, the controller 114 can detect a change in position (e.g., from lying down to standing) based on pressure readings (e.g., from pressure sensor 131 and / or pressure sensor 130), and the controller 114 is configured to adjust the pressure in the expandable member 104.

[0048] In some examples, the electronic pump assembly 106 includes a sealed enclosure 108 that encloses its components. The sealed enclosure 108 can be an airtight (or substantially airtight) container. The sealed enclosure 108 can include one or more metal-based materials. In some examples, the sealed enclosure 108 is a titanium container. In some examples, the only material in contact with the patient is titanium. In some examples, the sealed enclosure 108 includes one or more non-metal-based materials (e.g., ceramics). In some examples, a portion of the sealed enclosure 108 is a metal-based material and a portion of the sealed enclosure 108 is a non-metal-based material. In some examples, the sealed enclosure 108 defines a feed-through (e.g., a sealed feed-through, an electrical feed-through, a feed-through connector, etc.) for receiving / transmitting wireless signals from / to the external device 101. In some examples, the feed-through includes a metal-based material and an insulator-based material (e.g., ceramics).

[0049] 2 illustrates an implantable device 200 according to one embodiment. The implantable device 200 may be an example of the implantable device 100 of FIG. 1 and may include any of the details discussed with reference to FIG. 1. In some examples, the implantable device 200 is an inflatable penile prosthesis. In some examples, the implantable device 200 is an artificial urinary sphincter device. However, the implantable device 200 may include any type of medical device that transfers fluid between its components.

[0050] According to one aspect, the implantable device 200 includes a fluid reservoir 202, an inflatable member 204, and an electronic pump assembly 206 configured to transfer fluid between the fluid reservoir 202 and the inflatable member 204. The electronic pump assembly 206 can be similar to the electronic pump assembly 106 of FIG. 1 except that the electronic pump assembly 206 includes a pump 220 and a pump 221. The pump 220 and the pump 221 are arranged in series with each other. In some examples, the pump 220 and the pump 221 are activated during a deflation cycle to transfer fluid back to the fluid reservoir 202. In some examples, the use of the pumps in series can reduce the time during which the pressure in the inflatable member 204 can be reduced. The electronic pump assembly 206 further includes an active valve 218. The active valve 218 is in parallel with the pump 220 and the pump 221. The electronic pump assembly 206 includes a pressure sensor 230 configured to monitor the pressure of the inflatable member 204. In some examples, the electronic pump assembly 206 includes a pressure sensor 231 configured to monitor the pressure of the fluid reservoir 202 .

[0051] FIG. 3 illustrates an implantable device 300 according to one embodiment. The implantable device 300 may be an example of the implantable device 100 of FIG. 1 and / or the implantable device 200 of FIG. 2 and may include any of the details discussed with reference to those figures. In some examples, the implantable device 300 is an inflatable penile prosthesis. In some examples, the implantable device 300 is an artificial urinary sphincter device. However, the implantable device 300 may include any type of medical device that transfers fluid between its components.

[0052] According to one aspect, the implantable device 300 includes a fluid reservoir 302, an expandable member 304, and an electronic pump assembly 306 configured to transfer fluid between the fluid reservoir 302 and the expandable member 304. The electronic pump assembly 306 includes a pump 320, a pump 321, and an active valve 319. The pump 320, the pump 321, and the active valve 319 are in series with each other. The electronic pump assembly 306 can include an active valve 318. The active valve 318 can be in parallel with the pump 320, the pump 321, and the active valve 319. The electronic pump assembly 306 includes a pressure sensor 330 configured to monitor the pressure of the expandable member 304 and a pressure sensor 331 configured to monitor the pressure of the fluid reservoir 302. During an inflation cycle, the active valve 319 can be in a closed position. In some examples, active valve 319 can reduce leakage through pump 320 and / or pump 321. During a contraction cycle, active valve 319 can be moved to an open position to allow transfer of fluid into pump 321 and pump 320.

[0053] 4 illustrates an implantable device 400 according to one embodiment. The implantable device 400 may be an example of the implantable device 100 of FIG. 1 and may include any of the details discussed with reference to FIG. 1. In some examples, the implantable device 400 is an inflatable penile prosthesis. In some examples, the implantable device 400 is an artificial urinary sphincter device. However, the implantable device 400 may include any type of medical device that transfers fluid between its components.

[0054] Implantable device 400 includes a fluid reservoir 402, an expandable member 404, and an electronic pump assembly 406 configured to transfer fluid between fluid reservoir 402 and expandable member 404. Electronic pump assembly 406 includes pump 420 and pump 421. Pump 421 and pump 420 are in parallel with each other. Electronic pump assembly 406 includes active valve 418. Active valve 418 is in parallel with pump 420 and pump 421. Electronic pump assembly 406 includes pressure sensor 430 configured to monitor the pressure of expandable member 404 and pressure sensor 431 configured to monitor the pressure of fluid reservoir 402.

[0055] In some examples, the use of two pumps (e.g., pump 420, pump 421) in parallel (or more than two pumps in parallel) can increase the amount of fluid that can be transferred from the inflatable member 404 to the fluid reservoir 402. In some examples, the pump 420 and the pump 421 can be operated out of phase with each other to increase the efficiency of the electronic pump assembly 406. Two pumps (e.g., pump 420, pump 421) in parallel operating out of phase with each other (e.g., 180 degrees out of phase) can allow the output pressure of pump 420 to improve valve closure of pump 421 (and vice versa), thereby improving overall performance. The use of parallel pumps operating out of phase with each other can allow these pumps to operate at a lower frequency, thereby reducing power (and thus extending battery life). Furthermore, a smoother flow rate can be achieved, resulting in less vibration and an improved patient experience. In some examples, pump 420 and pump 421 operate at different pumping speeds, where one pump transfers fluid into fluid reservoir 402 at a faster rate than the other pump. For example, pump 420 can be operated at a first pumping speed and pump 421 can be operated at a second pumping speed, where the second pumping speed is lower than the first pumping speed.

[0056] 5 shows a flow chart 500 depicting exemplary operations for transferring a fluid within an implantable device according to one embodiment. Although flow chart 500 is described with respect to implantable device 100 of FIG. 1, the exemplary operations of flow chart 500 may be performed by any of the devices discussed herein.

[0057] Operation 502 includes receiving a wireless control signal 109 from the external device 101 by the antenna 112 of the electronic pump assembly 106. Operation 504 includes generating a first control signal by the controller 114 in response to the wireless control signal 109 for controlling an active valve 118 of the electronic pump assembly 106. Operation 506 includes actuating the active valve 118 to an open position in response to the first control signal to transfer fluid from the pressurized fluid reservoir 102 to the expandable member 104 until pressure in the expandable member 104 reaches a threshold level.

[0058] 6 illustrates a urethral control device 600 having an electronic pump assembly 606 according to one embodiment. The electronic pump assembly 606 can include any of the features of the electronic pump assemblies (e.g., 106, 206, 306, 406) and implantable devices (e.g., 100, 200, 300, 400) discussed herein. The urethral control device 600 includes a pump assembly 606, a fluid reservoir 602, and a cuff 604.

[0059] The fluid reservoir 602 may be a pressure-regulated inflation balloon or element. The fluid reservoir 602 is in operative fluid communication with the cuff 604 through one or more tubular members 603, 605. The fluid reservoir 602 is comprised of a polymeric material capable of elastic deformation to reduce the fluid volume therein and expel the fluid therefrom into the cuff 604. However, the material of the fluid reservoir 602 may preferably or include a shape memory structure adapted to maintain the fluid reservoir 602 in a generally expanded state while having a relatively constant fluid volume and pressure. In some examples, this constant level of pressure exerted by the fluid reservoir 602 on the cuff 604 will keep the cuff 604 in a desired expanded state when a fluid communication condition is provided between the fluid reservoir 602 and the cuff 604. This is primarily due to the fact that only a small level of fluid displacement is required to inflate or deflate the cuff 604. In some examples, the fluid reservoir 602 is implanted in the abdominal space.

[0060] A user can control the urethral control device 600 using the external device 601. In some examples, the user can inflate or deflate the cuff 604 using the external device 601. For example, in response to a user initiating an inflation cycle using the external device 601, the external device 601 can send a wireless signal to the electronic pump assembly 606 to initiate an inflation cycle to transfer fluid from the fluid reservoir 602 to the cuff 604 (e.g., by opening an active valve such that pressure in the fluid reservoir 602 moves fluid through the active valve to the cuff 604). In some examples, in response to a user initiating a deflation cycle using the external device 601, the external device 601 can send a wireless signal to the electronic pump assembly 606 to initiate a deflation cycle to pump fluid from the cuff 604 to the fluid reservoir 602.

[0061] FIG. 7 illustrates, in a simplified manner, an inflatable penile prosthesis 700 having an electronic pump assembly 706 according to one embodiment. The electronic pump assembly 706 can include any of the features of the electronic pump assemblies (e.g., 106, 206, 306, 406) and implantable devices (e.g., 100, 200, 300, 400) discussed herein. The inflatable penile prosthesis 700 can include an inflatable member 704 (e.g., a pair of inflatable cylinders 710) configured to be implanted within the penis. For example, one of the inflatable cylinders 710 can be disposed on one side of the penis and the other inflatable cylinder 710 can be disposed on the other side of the penis. Each inflatable cylinder 710 can include a first end portion 724, a cavity or expansion chamber 722, and a second end portion 728 having a rear tip 732.

[0062] At least a portion of the electronic pump assembly 706 can be implanted in the patient. A pair of conduit connectors 705 can attach the electronic pump assembly 706 to the inflatable cylinder 710 such that the electronic pump assembly 706 is in fluid communication with the inflatable cylinder 710. Similarly, the electronic pump assembly 706 can be in fluid communication with the fluid reservoir 702 through the conduit connector 703. The fluid reservoir 702 can be implanted in the abdomen of the user. The expansion chamber 722 of the inflatable cylinder 710 can be disposed in the penis. The first end portion 724 of the inflatable cylinder 710 can be disposed at least partially in the glans portion of the penis. The second end portion 728 can be implanted in the patient's pubic region PR with the rear tip 732 proximate the pubic bone PB.

[0063] To implant the expandable cylinder 710, the surgeon first prepares the patient. In many cases, the surgeon will create an incision in the penoscrotal region, for example, where the base of the penis meets the top of the scrotum. The surgeon can expand the patient's corpus cavernosum from the penoscrotal incision to prepare the patient to receive the expandable cylinder 710. The corpus cavernosum is one of two parallel columns of erectile tissue, e.g., two elongated columns that run substantially the entire length of the penis, that form the dorsal portion of the body of the penis. The surgeon will also expand two areas of the pubic region to prepare the patient to receive the second end portion 728. The surgeon can measure the length of the corpus cavernosum from the incision and the length of the expanded region of the pubic region to determine the appropriate size of the expandable cylinder 710 to be implanted.

[0064] After the patient is prepared, the inflatable penile prosthesis 700 is implanted in the patient. The tip of the first end portion 724 of each inflatable cylinder 710 can be attached to a suture. The other end of the suture can be attached to a needle (e.g., a Keith needle). The needle is inserted into the incision and into the expanded corpus cavernosum. The needle is then pushed through the glans of the penis. The surgeon pulls on the suture to draw the inflatable cylinder 710 into the corpus cavernosum. This is done for each inflatable cylinder 710 of the pair. Once the expansion chamber 722 is in place, the surgeon can remove the suture from the tip. The surgeon then inserts the second end portion 728. The surgeon inserts the rear end of the inflatable cylinder 710 into the incision and pushes the second end portion 728 toward the pubic bone PB until each inflatable cylinder 710 is in place.

[0065] A user can control the inflatable penile prosthesis 700 using the external device 701. In some examples, the user can use the external device 701 to inflate or deflate the inflatable cylinder 710. For example, in response to a user initiating an inflation cycle using the external device 701, the external device 701 can send a wireless signal to the electronic pump assembly 706 to initiate an inflation cycle and transfer fluid from the fluid reservoir 702 to the inflatable cylinder 710. In some examples, in response to a user initiating a deflation cycle using the external device 701, the external device 701 can send a wireless signal to the electronic pump assembly 706 to initiate a deflation cycle and transfer fluid from the inflatable cylinder 710 to the fluid reservoir 702. In some examples, during a deflation cycle, fluid is transferred back until the pressure in the inflatable cylinder 710 reaches a partial inflation pressure.

[0066] Detailed embodiments are disclosed herein. However, it is understood that the disclosed embodiments are merely examples that 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 representative basis for teaching those skilled in the art to further adapt these embodiments to virtually any suitable detailed structure as a basis for the claims. Furthermore, the terms and phrases used herein are not limiting, but are intended to provide an understandable description of the present disclosure.

[0067] The terms "a" or "an," as used herein, are defined as one or more than one. The term "another," as used herein, is defined as at least a second or more. The terms "including" and / or "having," as used herein, are defined as comprising (i.e., an open transition). The terms "coupled" or "movably coupled," as used herein, are defined as a connection, but not necessarily a direct, mechanical connection.

[0068] In general, embodiments relate to body implants. In this specification, the terms patient or user can be used for an individual who can benefit from the medical device or method disclosed in the present disclosure. For example, a patient can be an individual whose body is implanted with the medical device or method of operating the same disclosed by the present disclosure.

[0069] While certain features of the described embodiments have been illustrated as described herein, many modifications, substitutions, variations, and equivalents will now 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 variations as fall within the scope of the embodiments. [Explanation of symbols]

[0070] 100 Implantable Devices 102 Fluid Reservoir 104 Expandable member 106 Electronic Pump Assembly 118 Active Valve

Claims

1. a pressurized fluid reservoir configured to hold a fluid; an expandable member; 1. An electronic pump assembly comprising: A pump, An active valve; a pressure sensor configured to monitor a pressure in the expandable member; a controller configured to place the active valve in an open position during at least a portion of an expansion cycle to allow the fluid to be transferred from the pressurized fluid reservoir to the expandable member, the controller being configured to transition the active valve to a closed position in response to the pressure in the expandable member achieving a target pressure; an electronic pump assembly including:

1. An implantable device comprising:

2. The implantable device of claim 1 , wherein the controller is configured to actuate the pump during a deflation cycle to transfer the fluid from the expandable member to the pressurized fluid reservoir.

3. 3. The implantable device of claim 2, wherein the electronic pump assembly includes an antenna configured to receive a wireless control signal from an external device, and the controller is configured to initiate the inflation cycle or the deflation cycle based on the wireless control signal.

4. The implantable device of claim 1 , wherein the fluid is transferred from the pressurized fluid reservoir to the expandable member during the expansion cycle without the use of the pump.

5. The implantable device of claim 1 , wherein the active valve is positioned in parallel with the pump.

6. 6. The implantable device of claim 1, wherein the controller is configured to control the pump to operate to transfer a portion of the fluid from the expandable member to the pressurized fluid reservoir in response to the pressure in the expandable member being higher than the target pressure.

7. 7. The implantable device of claim 1, wherein the controller is configured to transition the active valve from the open position to a partially open position in response to the pressure exceeding a threshold level that is lower than the target pressure.

8. 8. The implantable device of claim 1, wherein the pressure sensor is a first pressure sensor and the electronic pump assembly includes a second pressure sensor configured to monitor the pressure of the pressurized fluid reservoir.

9. 9. The implantable device of claim 8, wherein the controller is configured to place the active valve in the open position for a period of time in response to the pressure in the pressurized fluid reservoir exceeding a threshold level.

10. 9. The implantable device of claim 8, wherein the controller is configured to detect a patient's position of the implantable device based on pressure readings from at least one of the first pressure sensor or the second pressure sensor, and the controller is configured to adjust the pressure of the expandable member based on the detected position.

11. The implantable device of claim 1 , wherein the pump is a first pump and the electronic pump assembly includes a second pump.

12. The implantable device of claim 11 , wherein the second pump is in series with the first pump.

13. 1. A method of operating an implantable device, comprising: receiving, by an antenna of the electronic pump assembly, a wireless control signal from an external device; generating, by a controller, a first control signal for controlling an active valve of the electronic pump assembly in response to the wireless control signal; in response to the first control signal, actuating the active valve to an open position to transfer fluid from a pressurized fluid reservoir to the expandable member until pressure at the expandable member reaches a threshold level; The method includes:

14. generating, by the controller, a second control signal for controlling a pump of the electronic pump assembly; operating the pump in response to the second control signal to transfer the fluid from the expandable member to the pressurized fluid reservoir; The method of claim 13 further comprising:

15. detecting, by the controller, that the pressure in the expandable member exceeds the threshold level, the second control signal being generated in response to the pressure in the expandable member being detected to exceed the threshold level; 15. The method of claim 14 further comprising:

16. a pressurized fluid reservoir configured to hold a fluid; an expandable member; 1. An electronic pump assembly comprising: A pump, An active valve; a pressure sensor configured to monitor a pressure in the expandable member; a controller configured to place the active valve in an open position during at least a portion of an expansion cycle to allow the fluid to be transferred from the pressurized fluid reservoir to the expandable member, the controller being configured to transition the active valve to a closed position in response to the pressure in the expandable member achieving a target pressure; an electronic pump assembly including:

1. An implantable device comprising:

17. 17. The implantable device of claim 16, wherein the controller is configured to actuate the pump during a deflation cycle to transfer the fluid from the expandable member to the pressurized fluid reservoir.

18. 18. The implantable device of claim 17, wherein the electronic pump assembly includes an antenna configured to receive a wireless control signal from an external device, and the controller is configured to initiate the inflation cycle or the deflation cycle based on the wireless control signal.

19. 17. The implantable device of claim 16, wherein the fluid is transferred from the pressurized fluid reservoir to the expandable member during the expansion cycle without the use of the pump.

20. The implantable device of claim 16 , wherein the active valve is positioned in parallel with the pump.

21. 17. The implantable device of claim 16, wherein the controller is configured to control the pump to operate to transfer a portion of the fluid from the expandable member to the pressurized fluid reservoir in response to the pressure in the expandable member being greater than the target pressure.

22. 17. The implantable device of claim 16, wherein the controller is configured to transition the active valve from the open position to a partially open position in response to the pressure exceeding a threshold level that is less than the target pressure.

23. 17. The implantable device of claim 16, wherein the pressure sensor is a first pressure sensor and the electronic pump assembly includes a second pressure sensor configured to monitor the pressure of the pressurized fluid reservoir.

24. 24. The implantable device of claim 23, wherein the controller is configured to place the active valve in the open position for a period of time in response to the pressure in the pressurized fluid reservoir exceeding a threshold level.

25. 24. The implantable device of claim 23, wherein the controller is configured to detect a patient's position of the implantable device based on pressure readings from at least one of the first pressure sensor or the second pressure sensor, and the controller is configured to adjust the pressure of the expandable member based on the detected position.

26. a pressurized fluid reservoir configured to hold a fluid; an expandable member; 1. An electronic pump assembly comprising: A pump, An active valve; a pressure sensor configured to monitor a pressure in the expandable member; a controller configured to place the active valve in an open position during at least a portion of an expansion cycle until the pressure in the expandable member achieves a target pressure; an electronic pump assembly including:

1. An implantable device comprising:

27. 27. The implantable device of claim 26, wherein the controller is configured to actuate the pump during a deflation cycle to transfer the fluid from the expandable member to the pressurized fluid reservoir.

28. 28. The implantable device of claim 27, wherein the electronic pump assembly includes an antenna configured to receive a wireless control signal from an external device, and the controller is configured to initiate the inflation cycle or the deflation cycle based on the wireless control signal.

29. 27. The implantable device of claim 26, wherein the active valve is positioned in parallel with the pump.

30. 27. The implantable device of claim 26, wherein the controller is configured to control the pump to operate to transfer a portion of the fluid from the expandable member to the pressurized fluid reservoir in response to the pressure in the expandable member being greater than the target pressure.

31. 27. The implantable device of claim 26, wherein the controller is configured to transition the active valve from the open position to a partially open position in response to the pressure exceeding a threshold level that is less than the target pressure.

32. 27. The implantable device of claim 26, wherein the pressure sensor is a first pressure sensor and the electronic pump assembly includes a second pressure sensor configured to monitor the pressure in the pressurized fluid reservoir, and the controller is configured to switch the active valve to the open position for a period of time in response to the pressure in the pressurized fluid reservoir exceeding a threshold level.

33. 1. A method of operating an implantable device, comprising: receiving, by an antenna of the electronic pump assembly, a wireless control signal from an external device; generating, by a controller, a first control signal for controlling an active valve of the electronic pump assembly in response to the wireless control signal; in response to the first control signal, actuating the active valve to an open position to transfer fluid from a pressurized fluid reservoir to the expandable member until pressure at the expandable member reaches a threshold level; The method includes:

34. generating, by the controller, a second control signal for controlling a pump of the electronic pump assembly; operating the pump in response to the second control signal to transfer the fluid from the expandable member to the pressurized fluid reservoir; 34. The method of claim 33, further comprising:

35. detecting, by the controller, that the pressure in the expandable member exceeds the threshold level, the second control signal being generated in response to the pressure in the expandable member being detected to exceed the threshold level; 35. The method of claim 34, further comprising:

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