Implantable medical device with fluid pump

Abstract

An implantable medical device (30) is disclosed. The implantable medical device includes a housing (32) forming an interior compartment (34). The housing includes a frame (36) disposed within the interior compartment that forms a first partition (38) and a second partition (40) within the interior compartment. The first partition is hermetically sealed with respect to the second partition. At least one electronic component (44) and the power source are disposed within the first partition. The medical device includes a fluid circuit (46) including a manifold operably coupled to at least one fluid component. The fluid circuit is operably coupled to the at least one electronic component across the frame.

Description

[0001] Cross-reference to related applications

[0002] This application is a continuation-to-priority application of U.S. nonprovisional patent application No. 18 / 733,392, filed June 4, 2024, entitled “IMPLANTABLE MEDICAL DEVICE WITH FLUIDICS PUMP,” which claims priority to U.S. provisional patent application No. 63 / 508,779, filed June 16, 2023, entitled “IMPLANTABLE MEDICAL DEVICE WITH FLUIDICS PUMP,” the contents of which are incorporated herein by reference in their entirety.

[0003] This application also claims priority to U.S. Provisional Patent Application No. 63 / 508,779, filed June 16, 2023, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0004] This disclosure generally relates to medical systems and implantable medical devices. More specifically, this disclosure relates to implantable medical devices that include fluid pumps. Background Technology

[0005] Implantable medical devices include electromechanical or electromechanical medical devices that are implanted in a patient's body and perform tasks such as monitoring patient parameters or delivering treatment to the patient via electrical energy. For example, an implantable medical device could be an implantable urinary system device implanted in a patient to treat conditions such as erectile dysfunction, penile deformity, or incontinence (as an implantable fluid-operated expandable device). Implantable fluid-operated expandable devices typically include one or more pumps that regulate the flow of fluid between different parts of the implantable device to provide expansion and contraction of the fluid-fillable implantable components of the device. Valves may be positioned within the fluid channels of the device to guide and control the flow of fluid to achieve expansion, contraction, pressurization, depressurization, activation, or deactivation of the different fluid-fillable implantable components of the device. In some implantable fluid-operated expandable devices, sensors may be used to monitor fluid pressure, fluid volume, or fluid flow rate within the fluid channels of the device. Summary of the Invention

[0006] In Example 1, the implantable medical device includes a housing forming an internal compartment. The housing includes a frame disposed within the internal compartment, the frame forming a first partition and a second partition within the internal compartment. The first partition is hermetically sealed relative to the second partition. At least one electronic component and a power source are disposed within the first partition. The medical device includes a fluid circuit including a manifold operatively coupled to at least one fluid component. The fluid circuit is operatively coupled to at least one electronic component across the frame.

[0007] In Example 2, the implantable medical device of Example 1 is included in an implantable urinary system device.

[0008] In Example 3, the implantable medical device of Example 2 is an inflatable penile prosthesis.

[0009] In Example 4, an implantable medical device of any of Examples 2-3, wherein the implantable urinary system device includes a reservoir having fluid, and the implantable medical device is in fluid communication with the reservoir.

[0010] In Example 5, the implantable medical device of Example 4, wherein the implantable urinary system device includes a plurality of expandable cylinders for receiving fluid, the implantable medical device being in fluid communication with the plurality of expandable cylinders, and wherein the implantable medical device is configured to pump fluid from a reservoir to the plurality of expandable cylinders.

[0011] In Example 6, an implantable medical device of any of Examples 1-5 is included in a medical system, which further includes a remote charger and a remote programmer.

[0012] In Example 7, the implantable medical device of Example 6 is provided, wherein a remote charger is operatively coupled to an interface system to provide transdermal inductive power transfer to a secondary conductor.

[0013] In Example 8, an implantable medical device of any of Examples 6-7, wherein the programmer is a handheld programmer that communicates with a communication system via an antenna at radio frequency.

[0014] In Example 9, the implantable medical device of Example 8 includes a programmer comprising a software application that operates on a mobile computing device to operate the implantable medical device.

[0015] In Example 10, an implantable medical device of any of Examples 1-9, wherein a fluid circuit is operatively coupled to at least one electronic component across the frame via an hermetically sealed feedthrough connector.

[0016] In Example 11, an implantable medical device of any of Examples 1-10 is provided, wherein the manifold and frame are integrally formed.

[0017] In Example 12, the implantable medical device of Example 11 has at least one electronic component coupled to the manifold in a first partition.

[0018] In Example 13, the implantable medical device of Examples 1-12 is shown, wherein the fluid components are arranged in a planar configuration.

[0019] In Example 14, the implantable medical device of Example 12 includes a fluid component comprising two piezoelectric pumps in a single fluid passage.

[0020] In Example 15, the implantable medical device of Example 14 includes a fluid component that further comprises a valve and a pressure sensor in a single fluid passage.

[0021] In Example 16, an implantable medical device is provided. The implantable medical device includes a housing forming an internal compartment. The housing includes a frame disposed within the internal compartment, the frame forming a first partition and a second partition within the internal compartment. The first partition is hermetically sealed relative to the second partition. At least one electronic component and a power source are disposed within the first partition. The medical device includes a fluid circuit including a manifold operatively coupled to at least one fluid component. The fluid circuit is operatively coupled to at least one electronic component across the frame.

[0022] In Example 17, the implantable medical device of Example 16 is provided, wherein the power source is a rechargeable power source including a battery.

[0023] In Example 18, the implantable medical device of Example 17 includes an electronic component comprising a communication system and a recharging system, the recharging system being coupled to a power source.

[0024] In Example 19, the implantable medical device of Example 18 further includes an antenna operatively coupled to a communication system and a secondary coil operatively coupled to a recharging system.

[0025] In Example 20, the implantable medical device of Example 19 has an antenna and a secondary coil disposed outside an internal compartment, wherein a connector is operatively coupled to a housing outside the internal compartment and forms an internal region, and the antenna and secondary coil are disposed within the internal region.

[0026] In Example 21, the implantable medical device of Example 16 is shown, wherein the manifold and frame are integrally formed.

[0027] In Example 22, the implantable medical device of Example 21 is provided, wherein the manifold is hermetically sealed to the housing to form a first partition and a second partition.

[0028] In Example 23, the implantable medical device of Example 22 has at least one electronic component coupled to the manifold in the first partition.

[0029] In Example 24, the implantable medical device of Example 16 is provided, wherein a fluid circuit is operatively coupled to at least one electronic component across the frame via an hermetically sealed feedthrough connector.

[0030] In Example 25, the implantable medical device of Example 16 has fluid components arranged in a planar configuration.

[0031] In Example 26, the implantable medical device of Example 25 includes a fluid component comprising two piezoelectric pumps in a single fluid passage.

[0032] In Example 27, the implantable medical device of Example 26 includes a fluid component that further comprises a valve and a pressure sensor in a single fluid passage.

[0033] In Example 28, the implantable medical device of Example 16 is shown, wherein fluid components are arranged in a stacked configuration.

[0034] In Example 29, a method of manufacturing an implantable medical system is disclosed. A frame including a fluid manifold is formed. The fluid manifold includes a first main surface and a second main surface. At least one electronic component and a power source are operatively coupled to the first main surface. At least one fluid component is operatively coupled to the second main surface to form a fluid circuit. A housing is attached to the frame to form an internal compartment, wherein the frame defines a first partition and a second partition of the internal compartment, the first partition and the second partition being hermetically sealed. At least one electronic component is operatively coupled across the frame to the fluid circuit.

[0035] In Example 30, the method of Example 29 further includes forming a channel within a fluid manifold and a chamber in a second main surface, the chamber being fluidly coupled to the channel, wherein at least one fluid component is operatively coupled to the chamber.

[0036] In Example 31, the method of Example 29 is used, where the manifold is formed integrally with the frame.

[0037] In Example 32, the implantable urinary system device includes a reservoir configured to receive fluid, an expandable member in fluid communication with the reservoir, and an implantable medical device. The implantable medical device includes a housing forming an internal compartment. The housing includes a frame disposed within the internal compartment, the frame forming a first partition and a second partition within the internal compartment. The first partition is hermetically sealed relative to the second partition. At least one electronic component and a power source are disposed within the first partition. The medical device includes a fluid circuit comprising a manifold operatively coupled to at least one fluid component. The fluid circuit is operatively coupled to at least one electronic component across the frame.

[0038] In Example 33, the implantable urinary system device of Example 32 includes an expandable component comprising a plurality of expandable cylinders in fluid communication with a medical actuation device and a reservoir, the plurality of expandable cylinders being configured to be disposed within the corpora cavernosa of the penis.

[0039] In Example 34, the implantable urinary system device of Example 32 is provided, wherein the medical device is configured to be disposed within the retropubic space.

[0040] In Example 35, there is an implantable urinary system device of Example 32, wherein the manifold is integrally formed with the frame.

[0041] While several embodiments have been disclosed, other embodiments of this disclosure will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative embodiments of this disclosure. Therefore, the drawings and detailed description are to be considered illustrative in nature and not restrictive. Attached Figure Description

[0042] Figure 1 This is a schematic diagram illustrating an exemplary implantable medical system of the present disclosure, which includes an exemplary implantable medical device, an exemplary external charger, and an exemplary programmer.

[0043] Figure 2 It shows including Figure 1 A schematic diagram of an exemplary implantable urinary system device, featuring the characteristics of an exemplary implantable medical device.

[0044] Figure 3A It is shown Figure 2 A schematic diagram of an exemplary fluid architecture for an exemplary implantable urinary system device.

[0045] Figure 3B It is shown Figure 2 A schematic diagram of another exemplary fluid architecture for an exemplary implantable urinary system device.

[0046] Figure 4A It is shown Figure 2 A perspective view of exemplary features of an exemplary implantable urinary system device.

[0047] Figure 4B The structure is shown by dashed lines. Figure 4A A perspective view of an exemplary feature.

[0048] Figure 4C The structure is shown by dashed lines. Figure 2 A perspective view of exemplary features of an exemplary implantable urinary system device.

[0049] Figures 5A-5C It is shown that... Figure 2 A schematic diagram illustrating exemplary operation of a piezoelectric pump assembly used with an exemplary implantable urinary system device.

[0050] Figures 6A-6C It is shown that... Figure 2 A schematic diagram illustrating exemplary operation of another piezoelectric pump assembly used in conjunction with an exemplary implantable urinary system device.

[0051] Figure 7 yes Figure 2An exploded view of exemplary features of an exemplary implantable urinary system device.

[0052] Figure 8 yes Figure 2 A perspective view of another exemplary feature of an exemplary implantable urinary system device.

[0053] Figure 9 yes Figure 8 An exploded diagram of exemplary features.

[0054] While this disclosure is applicable to various modifications and alternatives, specific embodiments are shown by way of example in the accompanying drawings and are described in detail below. However, the purpose of this disclosure is not to limit it to the specific embodiments described. Rather, this disclosure is intended to cover all modifications, equivalents, and alternatives that fall within the scope of this disclosure as defined by the appended claims. Detailed Implementation

[0055] For the purpose of facilitating an understanding of the principles of this disclosure, reference is now made to the examples shown in the accompanying drawings, which will be described below. The examples shown herein are not intended to be exhaustive or to limit this disclosure to the precise forms disclosed in the following detailed description. Rather, these exemplary embodiments were chosen and described to enable others skilled in the art to use their teachings. Multiple (e.g., all) features in the examples used in all the examples do not exceed the scope of this disclosure. Therefore, no single figure should be construed as having any dependency or requirement associated with any individual component or combination of components shown therein. Furthermore, in the examples, the various components depicted in the figures may be integrated with various components in other components (or components not shown) depicted therein, all of which are considered to be within the scope of this disclosure.

[0056] Figure 1 An implantable medical device system 20 is illustrated. The implantable medical system 20 includes an implantable medical device 30 that can be fully implanted into a patient 22. The implantable medical device 30 may include a housing 32 forming an internal compartment 34. The housing 32 includes a frame 36 located within the internal compartment 34, the frame 36 forming a first partition 38 and a second partition 40. The first partition 38 and the second partition 40 are hermetically sealed. The implantable medical device 30 may include an energy storage system (such as a rechargeable power supply 42 or a rechargeable battery) and electronic components 44 within the first partition 38. A fluid loop 46 is included within the second partition 40. The fluid loop 46 is operatively coupled to the electronic components 44 across the frame 36, such as via a hermetically sealed interface 48. In the illustrated example, the rechargeable power supply 42 and the electronic components 44 may be coupled to structures capable of receiving and transmitting communication signals and receiving power signals, such as coils and antennas.

[0057] The implantable medical device 30 may include or be coupled to a reservoir 50 filled with fluid 52 (such as a sterile saline solution) in fluid communication with a fluid circuit 46. Additionally, the implantable medical device 30 may include or be coupled to an expandable member 54 in fluid communication with the fluid circuit 46 and the reservoir 50 to receive fluid. Electronic components 44 powered by a rechargeable power source 42 can provide monitoring and control of various operations of the fluid circuit 46. The fluid circuit 46 can provide transfer of fluid 52 between the reservoir 50 and the expandable member 52. In one example, the fluid circuit 46 may include a manifold and fluid components such as a pump assembly, a valve assembly, and a pressure sensor. In one example, electronic components 44 may include a recharging system, a communication system, and a control system.

[0058] The implantable medical system 20 also includes a charger 60, which may also be referred to as a wireless recharger, located outside the patient 22 or across the percutaneous boundary 24 (such as near the patient's skin surface of the implantable medical device 30) to provide a power signal and, in some examples, communicate with the medical device 30. In some examples, percutaneous charging is performed via radio frequency power transfer or transmission or inductive power transfer or transmission. In this example, the external charger 60 is not mechanically connected to the implantable medical device, and the external charger can be used to charge the implantable medical device 30 from a relatively short distance. In one example, the charger 60 is placed on the patient 22 and close to the implantable medical device 30 to inductively transfer energy and replenish the battery of the implantable medical device 30.

[0059] In the example of charger 60, inductive power transfer can be performed via inductive coupling between conductors, which can be coils of wire, such as the primary coil in charger 60 and the secondary coil in implantable medical device 30. Power is transferred between the coils via a magnetic field. Alternating current through the primary coil generates an oscillating magnetic field. The magnetic field passes through the secondary coil and induces an alternating electromotive force or EMF (such as a voltage), which generates alternating current in the secondary conductor. The induced alternating current can directly drive a load in implantable medical device 30, or can be rectified to direct current by a rectifier in implantable medical device 30, which drives the load. Resonant inductive coupling is a type of inductive coupling in which power is transferred by the magnetic field between two resonant circuits, one in charger 60 and the other in implantable medical device 30. Each resonant circuit can include a coil of wire connected to a capacitor, or a self-resonant coil or other resonator with internal capacitance. The resonant circuits or energy storage circuits are tuned to resonate at approximately the same resonant frequency. Resonance between the conductors can significantly increase the coupling and power transfer between charger 60 and implantable medical device 30.

[0060] In this example, charger 60 delivers magnetic energy to the corresponding implantable device 30 at a preselected frequency via a resonant inductor-capacitor (LC) energy storage circuit to generate an H-field. The energy storage circuit includes a recharge coil connected in series with a recharge capacitor. Various configurations of charger 60 can share a common coil design, and the preselected recharge frequency is determined by the selected energy storage capacitance of the recharge capacitor. The energy storage circuit can oscillate at the resonant frequency. A phase-locked loop is created in the energy storage circuit by pulsed the applied energy storage voltage in phase with the energy storage current. During resonance, the energy storage current is approximately or approximately sinusoidal over time. The energy storage circuit achieves maximum energy storage power when the energy storage voltage pulse is time-aligned with the energy storage current. The recharge power can be adjusted by varying the amplitude and duty cycle of the energy storage voltage pulse input to the energy storage circuit.

[0061] Depending on the recharge frequency and communication scheme used with the implantable medical device 30, the charger 60 can be used in different configurations. For example, a first configuration of the charger 60 may support a bidirectional inductive telemetry communication scheme and a first recharge frequency; a second configuration of the charger 60 may support a radio frequency telemetry and downlink inductive telemetry communication scheme and a second recharge frequency; and a third configuration of the charger may support a bidirectional inductive telemetry communication scheme and a third recharge frequency. Inductive charging is presented in this disclosure for illustration, and the charger 60 may also use other forms of wireless charging to supplement the rechargeable power supply.

[0062] System 20 may also include a handheld programmer 70 configured to wirelessly dock and communicate with implantable medical device 30 or charger 60. In one example, handheld programmer 70 may be implemented as a general-purpose computing device or mobile computing device hosting software applications. For example, handheld programmer 70 may include a set of controls for percutaneously communicating with or operating implantable medical device 30 via a communication system, or communicating with or operating charger 60. Medical device 30 may include an antenna to receive and transmit communication signals with handheld programmer 70. For example, handheld programmer 70 and medical device 30 may communicate via radio frequency signals in the 2.400–2.4835 GHz range, such as Bluetooth Low Energy communication in a wireless personal network. Additionally or alternatively, handheld programmer 70 or charger 60 may employ other forms of wireless communication, which may include other forms of radio frequency communication or inductive communication. The handheld programmer 70 can be configured with a user interface (such as a graphical user interface) to wirelessly operate the medical device 30, such as by receiving commands via soft buttons, receiving feedback or parameters from the medical device 30, updating the control system on the medical device, and interfacing with a computer network to provide telemetry or allow remote computer network connection systems to control the medical device 30. For example, a user can use the handheld programmer 70 to actuate the medical device 30 to pump fluid 52 from the reservoir 50 to the expandable member 54, or to release fluid 52 from the expandable member 54 back to the reservoir 50.

[0063] The system disclosed herein may optionally include additional components. System 20 may include a charging dock that can be plugged into a wall socket and configured to charge the internal battery of charger 60. Charger 60 may also be used in conjunction with a fixation product of system 20 to hold charger 60 in proximity to implantable medical device 30 during a recharging session. Fixation product may include a fixation strap worn around a portion of patient 22, such as a strap around the abdomen, back, hip, or side of patient 22 for implantable medical device 30, or a weighted fixation cover worn around the neck to balance charger 60 of implantable medical device 30 in the chest region of patient 22. Fixation product receives charger 60 to hold charger 32 in place relative to fixation product such that, in one example, charger 60 does not rotate relative to implantable medical device 30 during a recharging session and generally does not move, and fixes charger 60 to prevent it from falling off unless intentionally removed from fixation product.

[0064] The implantable medical device 30 can be subcutaneously implanted in an implantation site or pocket within the body of a patient 22. In some examples, another component of the implantable medical device 30 may occupy the same or additional location within the body of the patient 22. The implantable medical device 30 can be configured to deliver treatment to a patient, monitor parameters within the patient's body, and receive and deliver signals to the patient, such as at regular intervals, continuously, or in response to detected events (such as events detected by sensors, received from another implantable device (not shown), or received from components of the implantable medical system 20, such as from a charger 60 or a handheld programmer 70). The implantable medical device 30 can be configured to detect various physiological signals that can be used to connect with various diagnostic, therapeutic, and other monitoring implementations. The implantable medical device 30 can be used in urology, neurology, cardiology, and other applicable fields that utilize implantable medical devices with power systems or for receiving and transmitting signals.

[0065] Figure 2 An exemplary implantable medical device 200 is illustrated, such as an implantable urinary system device connected to an expandable penile prosthesis, which may correspond to implantable medical device 30. In this example, implantable medical device 200 includes expandable components (such as a pair of expandable cylinders 202), a reservoir 204 that can be filled with fluid (such as a sterile saline solution 206), and an electromechanical actuation device 208 in a closed system. The reservoir 204 is fluidly coupled to the actuation device 208 via conduit 210, and the actuation device 208 is fluidly coupled to the cylinders 202 via conduit 212. For example, conduits 210, 212 may be anti-kink tubes made of silicone elastomer.

[0066] Actuation device 208 includes a hermetically sealed housing 220 formed of a biocompatible material, such as titanium or steel. In one example, housing 220 is formed via multiple walls welded together. Actuation device 208 includes an internal fluid circuit to fluidly couple reservoir 204 to cylinder 202 via conduits 210, 212. Internal electronics powered by a rechargeable power source can provide monitoring and control of various operations of the fluid circuit, such as the transfer of fluid 206 between reservoir 204 and cylinder 202. In one example, electromechanical actuation device 208 may correspond to implantable medical device 30, reservoir 204 and fluid 206 may correspond to reservoir 50 and fluid 52 respectively, and cylinder 202 may correspond to... Figure 1 The expandable component 54 corresponds to this.

[0067] The housing 220 forms an internal compartment defined by a space within the actuation device 208, which is defined by a plurality of walls. The internal compartment of the actuation device 208 is configured to house a rechargeable energy storage system, electronic components, and a fluid circuit. In one example, the internal compartment may include multiple partitions that may be separated by a frame and hermetically sealed to each other within the internal compartment. For example, the rechargeable energy storage system and electronic components may be housed in a first partition, and the fluid circuit may be housed in a second partition. The first partition is hermetically sealed relative to the second partition. Feedthrough pins may be applied to the hermetically sealed area to allow the electronic components to control and monitor the fluid circuit. In one example, the electronic components may be implemented using various components including resistors, capacitors, transistors, and integrated circuits, disposed on one or more printed circuit boards within the first partition of the internal compartment. The fluid circuit may be implemented via a titanium manifold and an electromagnetic or piezoelectric pump. In one example, the housing 220 may include attachment devices, such as loops 222, 224 forming walls to receive sutures that may be applied to anchor the actuation device 208 to a structure within the patient's body.

[0068] Actuation device 208 may include connector 226 to form a region including power and communication interface structures such as secondary coil 228 and antenna 230. Connector 226 is configured to allow the transmission of power and communication signals between secondary coil 228 and charger, and between antenna 230 and handheld programmer or charger. For example, connector 226 may be made of an overmolded polymer. The antenna and secondary coil are electrically coupled to electronic components within the first section, such as via hermetically sealed feedthroughs.

[0069] The cylinder 202 is typically implanted in the corpora cavernosa of the penis, and the reservoir 204 is typically implanted in the patient's retropubic space or Retzius space, or between the transverse and rectus muscles. The electromechanical actuation device 208 may be implanted in the abdomen at a location determined by a clinician. A sterile saline solution 206 may be pumped from the reservoir 204 into the chamber of the cylinder 202 via conduits 210, 212 under the actuation device 208. For example, the actuation device 208 may include an electromechanical pump and valve within a fluid circuit. The cylinder 202 replaces non-functional or limited-functioning erectile tissue in the penis, and the cylinder 202 inflated with the saline solution 206 produces an erection. After intercourse, the actuation device 208 releases the saline solution 206 from the cylinder 202, and the fluid returns to the reservoir 204 via conduits and a fluid circuit within the actuation device 208.

[0070] In another example of an implantable medical device incorporating the features of an electromechanical actuation device combining the features of medical device 30, an inflatable member 54 may correspond to an inflatable cuff, which may be implemented as an artificial urethral sphincter. In some embodiments, the inflatable cuff is positioned around the urethra near the bladder. An actuation device is applied to pump fluid from a reservoir to inflate the cuff and close the urethra. The cuff is tightened to allow the patient to empty the bladder. For illustrative purposes, this disclosure describes features of medical device 30 (such as medical device 200) with reference to penile prostheses, and the features of medical device 30 may be applied to other embodiments and components.

[0071] Figure 3A An example fluid architecture 300 for an implantable medical device 30 is shown, and the same components are labeled with the same reference numerals. The exemplary fluid architecture 300 includes pathways for guiding the flow of fluid 52 between a reservoir 50 and an expandable member 54 (such as a cylinder 202). A first valve V1 in a first fluid pathway controls the flow of fluid 52 generated by a first pumping device P1 from the expandable member 54 to the reservoir 50. A second valve V2 in a second fluid pathway controls the flow of fluid 52 generated by a second pumping device P2 from the reservoir 50 to the expandable member 54. In this example, a first pressure sensor S1 senses the fluid pressure at the reservoir 50, and a second pressure sensor S2 senses the fluid pressure at the expandable member 54. The first pressure sensor S1 and the second pressure sensor S2 provide monitoring of fluid flow and fluid pressure in the fluid pathways.

[0072] In the arrangement of the fluid architecture 300, one of the first pump P1 and the second pump P2 is in an active state, while the other of the first pump P1 and the second pump P2 is in a standby mode, such that the first pump and the second pump do not typically operate simultaneously. For example, when the second pump P2 is in standby mode, the operation of the first pump P1 provides compression of the expandable member 54, and when the first pump P1 is in standby mode, the operation of the second pump P2 provides expansion of the expandable member 54.

[0073] Valves V1 and V2 provide selective sealing of one or more corresponding fluid passages to maintain the set state of the implantable medical device 30. In some embodiments, valves V1 and V2 facilitate the transition between the states of the implantable medical device 30 (i.e., inflated and compressed states). For example, the selective sealing of one or more corresponding fluid passages by valves V1 and V2 maintains the inflatable member 54 in an inflated or compressed state. Interaction with valves V1 and V2 and corresponding changes in fluid flow through the fluid architecture 300 of the implantable medical device 30 can alter the set state of the implantable medical device 30. In the example shown, valves V1 and V2 are positioned downstream of the corresponding pumps P1 and P2. In alternative configurations, the order of valves V1 and V2 and the corresponding pumps P1 and P2 can be changed, such that pumps P1 and P2 are located downstream of the corresponding valves V1 and V2.

[0074] Figure 3B Another example fluid architecture 330 for an implantable medical device 30 is shown, and the same components are labeled with the same reference numerals. The exemplary fluid architecture 330 includes a pathway for guiding the flow of fluid 52 between a reservoir 50 and an expandable member 54, such as a cylinder 202. In one example, the cylinder 202 may be coupled to a Y-shaped connecting pipe in fluid communication with the pathway. A valve V10 in the fluid pathway controls the flow of fluid 52 generated by a first pumping device P10 and a second pumping device P12 from the reservoir 50 to the expandable member 54. In this example, a pressure sensor S10 senses the fluid pressure at the expandable member 54. The pressure sensor S10 provides monitoring of fluid flow and fluid pressure in the fluid pathway.

[0075] In the arrangement of the fluid architecture 330, the first pump P10 and the second pump P12 are simultaneously active or simultaneously inactive, such as in standby mode, such that the first pump P10 and the second pump P12 typically operate together. For example, the operation of the first pump P10 and the second pump P12 provides expansion of the expandable member 54. The first pump P10 and the second pump P12 are not operational and are in inactive and standby modes for compression of the expandable member 54.

[0076] Valve V10 provides a selective seal to the fluid passage to maintain the set state of the implantable medical device 30. In some embodiments, valve V10 facilitates the transition between the states of the implantable medical device 30 (i.e., expanded and contracted states). For example, the selective seal of the fluid passage by valve V10 maintains either the expanded or contracted state of the expandable member 54. The set state of the implantable medical device 30 can be altered by the interaction with valve V10 and the corresponding changes in fluid flow through the fluid architecture 330 of the implantable medical device 30. The order of fluid components such as valve V10, pumps P10 and P12, and pressure sensor S10 can be rearranged in the fluid passage to accommodate various considerations.

[0077] Figure 4A and 4B An example manifold 400 is shown for use with a fluid circuit 46 of an implantable medical device 30. The manifold in the fluid circuit 46 may employ a fluid architecture, such as fluid architecture 300 or 330, to provide controlled transfer and monitoring of fluid within the implantable medical device 30 between a fluid reservoir 50 and an expandable member 54. The example manifold 400 is shown employing fluid architecture 300. The manifold 400 may be referred to as a stacked manifold or configured in a stacked manner, such as when fluid components are located in multiple planes of the manifold.

[0078] Manifold 400 includes housing 410. In Figure 4B In the illustration, the housing 410 of the example manifold 400 is shown as a dashed line, illustrating the arrangement of the internal fluid passages and fluid components (such as valves, pumps, and sensors) of the manifold 400. The fluid passages are defined within the housing 410, with the fluid components residing within them. In some examples, the housing 410 may be made of a solid material. In some examples, the housing 410 is molded, such as by injection molding. In some examples, the housing 410 is made of a metallic material (e.g., titanium, steel) or other biocompatible material. This allows the fluid components to be mounted within the fluid passages defined within the housing 410 and allows the fluid passages to be sealed. The manifold 400 or housing 410 manufactured in this manner can be hermetically tight, such that the fluid flowing through the manifold 400 and the components received within the manifold 400 are contained within the manifold 400. In cases where one or more fluid components comprise non-biocompatible materials, the hermetically tight nature of the manifold 400 can prevent or reduce the possibility of these materials entering the patient's body.

[0079] exist Figure 4BIn the example shown, manifold 400 includes a first pump 450A in fluid communication with a first valve 460A via a first fluid passage 490A, and a second pump 450B in fluid communication with a second valve 460B via a second fluid passage 490B. The first pump 450A and the first valve 460A direct fluid out of manifold 400 through a first outlet port 430A, such as to a fluid-coupled reservoir 50. The second pump 450B and the second valve 460B direct fluid out of manifold 400 through a second outlet port 430B to a fluid-coupled expandable member 54. A first pressure sensor 420A senses the fluid pressure of the fluid flowing between manifold 400 and reservoir 50. A second pressure sensor 420B senses the fluid pressure of the fluid flowing between manifold 400 and expandable member 54.

[0080] In this example, the first pump 450A and the second pump 450B are coplanar in a first plane, and the first valve 460A and the second valve 460B are coplanar in a second plane, wherein the first plane is parallel to the second plane of the manifold. For example, the first pump 450A and the first valve 460A are opposite each other on the manifold 400, and the second pump 450B and the second valve 460B are opposite each other on the manifold 400.

[0081] In the example, the first valve 460A and the second valve 460B are normally open valves. In this arrangement, with the first valve 460A and the second valve 460B being normally open, the second valve 460B is actuated to close, while the first pump 450A operates to allow fluid to flow from the manifold 400 to the reservoir 50. Similarly, the first valve 460A is actuated to close, while the second pump 450B operates to allow fluid to flow from the manifold 400 to the expandable member 54. In the event of a fault, failure, or blockage within the fluid structure, the normally open valves can provide pressure relief at the expandable member 54.

[0082] Figure 4C An example manifold 401 is shown for use with the fluid circuit 46 of an implantable medical device 30. The example manifold 401 is shown employing a fluid architecture 330. The manifold 401 may be referred to as a planar manifold or configured in a planar manner, such as when the fluid components are located in a single plane of the manifold.

[0083] Manifold 401 includes a housing 411. A fluid passage is defined within the housing 411, with a fluid component located at the top of the fluid passage. In some examples, the housing 411 may be made of a solid material. In some examples, the housing 411 is molded, such as by injection molding. In some examples, the housing 411 is made of a metallic material (such as titanium, steel) or other biocompatible material. This allows the fluid component to be mounted within the fluid passage defined within the housing 411 and allows the fluid passage to be sealed. Manifold 401 or housing 411 manufactured in this way can be hermetically tight, such that the fluid flowing through manifold 401 and the component received in manifold 401 are contained within manifold 401. In cases where one or more fluid components comprise non-biocompatible materials, the hermetically tight nature of manifold 401 can prevent or reduce the possibility of these materials entering the patient's body.

[0084] exist Figure 4C In the example shown, manifold 401 includes a first port 431A in fluid communication with a first fluid passage 491A. A first pump 451A is in fluid communication with the first fluid passage 491A. The first pump 451A is in fluid communication with a first valve 461A via a second fluid passage 493A. Manifold 401 also includes a second port 431B in fluid communication with a third fluid passage 491B. A second pump 451B is in fluid communication with the third fluid passage 491B. The second pump 451B is in fluid communication with a second valve 461B via a fourth fluid passage 493B. The first pump 451A and the open first valve 461A direct fluid from the first outlet port 431A through the second outlet port 431B out of manifold 401—this is via the first fluid passage 491A to the second fluid passage 493A, and via the third fluid passage 491B, bypassing the second pump 451B. The second valve 461B is closed. The second pump 451B and the open second valve 461B direct fluid from the second outlet port 431B through the first outlet port 431A out of the manifold 401—this is bypassed by the first pump 451A in the first fluid channel 491A via the third fluid channel 491B and the fourth fluid channel 493B. The first valve 461B is closed. The pressure sensor 421 in the third fluid channel 491B senses the fluid pressure of the fluid flowing between the manifold 401 and the reservoir 50.

[0085] Figures 5A to 5C The operation of a pump (such as a piezoelectric pump assembly 500) is schematically illustrated, which may employ a fluid architecture (such as fluid architecture 300 or 330) and a stacked manifold configuration (such as manifold 400). Furthermore, the piezoelectric pump assembly 500 may employ a planar manifold in which fluid components such as pumps, valves, and pressure sensors are deployed in a plane.

[0086] Figure 5AA piezoelectric diaphragm 510 is shown located in a fluid chamber 520 of a piezoelectric diaphragm pumping device, which can provide pumping of fluid and pressure sensing. In this example, the piezoelectric diaphragm 510 is positioned along an edge portion of the chamber 520 and includes a monolayer disk 515 made of a piezoelectric material (e.g., a piezoelectric ceramic disk) mounted on a plate 525 or diaphragm 525 attached to an insulating diaphragm 535. A first check valve 531 is located on a first side of the chamber 520 (e.g., the inlet end of the chamber 520), corresponding to a first end of the piezoelectric diaphragm 510, and regulates the flow through the chamber 520 in a first direction. A second check valve 532 is located on a second side of the chamber 520 (e.g., the outlet end of the chamber 520), corresponding to a second end of the piezoelectric diaphragm 510, and regulates the flow through the chamber 520 in a second direction. Figure 5B As shown, the application or increase of voltage causes deformation of the piezoelectric ceramic disc 515 and corresponding upward strokes of the membrane 525 and diaphragm 535. The upward stroke of the disc 515 corresponding to the supply stroke draws fluid into the chamber 520 through the first check valve 531 to fill the chamber 520. Figure 5C As shown, the release or reduction of voltage causes deformation of disc 515 and a corresponding downward stroke. This downward stroke of disc 515, corresponding to the pressure stroke, discharges fluid from or out of chamber 520 via the second check valve 532. This pumping cycle can be repeated to continue pumping fluid into and out of or through chamber 520.

[0087] Figures 6A to 6C The operation of the dual piezoelectric pump and valve manifold device 600 is illustrated schematically. Specifically, Figures 6A to 6C The operation of the dual piezoelectric pump and valve device 600 is illustrated in the first, second, and third stages of the pumping cycle of fluid via the dual piezoelectric pump and valve device 600. The dual piezoelectric pump and valve manifold device 600 can employ a fluid architecture (such as fluid architecture 300 or 330) or a stacked manifold configuration, such as manifold 400 or a planar manifold.

[0088] exist Figure 6A In the first stage shown, the first check valve 631A and the second check valve 632A are in the closed position, preventing fluid from flowing into or out of the first chamber 620A corresponding to the first piezoelectric diaphragm 610A. Similarly, the first check valve 631B and the second check valve 632B are in the closed position, preventing fluid from flowing into or out of the second chamber 620B corresponding to the second piezoelectric diaphragm 610B.

[0089] In response to the application of voltage, the piezoelectric ceramic disk 615A and membrane 635A of the first piezoelectric diaphragm 610A perform an upward stroke or a supply stroke, while the piezoelectric ceramic disk 615B and membrane 635B of the second piezoelectric diaphragm 610B perform a downward stroke or a pressure stroke, to [transfer / receive] [the energy / to / from] [the source / to / the source]. Figure 6A The corresponding first-stage position shown Figure 6B The corresponding second-stage position is shown. A voltage can be applied to the piezoelectric ceramic disk 615A based on fluid pressure and / or fluid flow rate, for example, measured by one of the pressure sensors included in the fluid architecture described above. The upward stroke of the first piezoelectric diaphragm 610A reduces the pressure in the first chamber 620A, thereby opening the first check valve 631A and allowing fluid to flow through the first check valve 631A and into the first chamber 620A, while the second check valve 632A remains closed. The downward stroke of the second piezoelectric diaphragm 610B increases the pressure in the second chamber 620B, thereby opening the second check valve 632B and allowing fluid to flow out of the second chamber 620B and through the second check valve 632B, while the first check valve 631B remains closed.

[0090] In response to voltage removal, the piezoelectric ceramic disks 615A and membrane 635A of the first piezoelectric diaphragm 610A perform a downward stroke or pressure stroke, while the piezoelectric ceramic disks 615B and membrane 635B of the second piezoelectric diaphragm 610B perform an upward stroke or supply stroke to [transfer / receive / extract] [from / to / receive]. Figure 6B The corresponding second-stage position shown Figure 6C The corresponding third-stage position is shown. The removal of the voltage applied to the piezoelectric ceramic disk 615A can be based on fluid pressure and / or fluid flow rate measured, for example, by one of the pressure sensors included in the fluid architecture described above. The downward stroke of the first piezoelectric diaphragm 610A increases the pressure in the first chamber 620A to close the first check valve 631A and open the second check valve 632A, thereby allowing fluid to flow through the second check valve 632A and into the fluid passage toward the second chamber 620B. The upward stroke of the second piezoelectric diaphragm 610B decreases the pressure in the second chamber 620B to open the first check valve 631B and allow fluid to flow into the second chamber 620B, while the second check valve 632B remains closed.

[0091] Figures 6A-6C The first, second, and third stages of the pumping cycle of the dual piezoelectric pump and valve equipment are shown, illustrating the process from the first stage ( Figure 6A ) to the second stage ( Figure 6B The process involves refilling the fluid in the first chamber 620A and discharging the fluid accumulated in the second chamber 620B, as well as proceeding from the second stage ( Figure 6B ) to the third stage ( Figure 6C The fluid accumulated in the first chamber 620A is discharged and the fluid entering the second chamber 620B is refilled.

[0092] In reference Figures 6A-6CIn the described example, the dual piezoelectric pump and valve device includes first check valves 631A, 631B and second check valves 632A, 632B associated with flow through each chamber 620A, 620B, respectively. In some embodiments, the operation of the second check valve 632A of the first chamber 620A and the first check valve 631B of the second chamber 620B can be achieved using a single valve. Figures 6A-6C (Not shown in the image) Instead, this single valve can be used in conjunction with the reference. Figures 6A-6C The flow between the first chamber 620A and the second chamber 620B is controlled in a similar manner as described.

[0093] In some examples, current-mode sensing methods can be applied to determine the pressure in a piezoelectric diaphragm pump. Since current and pressure are linearly related, the pressure can be inferred from the amount of current required to move the diaphragm. In this current-mode sensing, the pressure can be sensed in each pumping cycle as described above, based on the amount of current required to move the diaphragm and fill / empty the corresponding chamber.

[0094] In some examples, inductive response methods can be applied to determine pressure. Inductive response methods can utilize the ability of piezoelectric materials to convert motion into voltage (in addition to movement in response to the application of electrical stimulation). Because the electromechanical actuation and response of piezoelectric materials are associated with alternating current (AC) signals, using a pump as a sensor, for example in a piezoelectric diaphragm pump, can only measure changes in pressure. In some examples, this can be overcome by controlling the input to one fluid chamber and measuring the output at another fluid chamber. The fluid architecture 330 can be implemented in an exemplary dual piezoelectric pump manifold configuration, such as... Figures 6A-6C The exemplary dual-pump and valve device shown has multiple chambers arranged in series. In this exemplary arrangement, a first chamber (e.g., first chamber 620A) may be connected to a second chamber (e.g., second chamber 620B) by a fluid passage. A known stimulus (i.e., a known voltage level or a known pulse level) is input at the first chamber, and the output (voltage level or pulse amplitude) at the second chamber is detected. In some examples, the static pressure may be determined based on the known pulse input applied to the first chamber and the resulting pulse output measured at the second chamber.

[0095] Figure 7 It shows Figure 2An exploded view of an exemplary actuation device 208, wherein like parts are labeled with the same reference numerals. The housing 220 includes a first sidewall 232, an opposing second sidewall 234, a peripheral wall 236, and a frame 240. In the exemplary actuation device 208, the first sidewall 232, the second sidewall 234, and the peripheral wall 236 are hermetically sealed together to form an internal compartment 250 within the housing 220. The frame 240 is disposed within the internal compartment 250, thereby forming a first partition 252 and a second partition 254 in a hermetically sealed manner relative to the second partition 254. In the example, the frame 240 may be integrally formed with the peripheral wall 236 or the first sidewall 232 or the second sidewall 234. In another example, the frame 240 is welded to the peripheral wall 236 or to the first sidewall 232 or the second sidewall 234. In the illustrated example, the first sidewall 232, the peripheral wall 236, and the frame 240 form the first partition 252. The second sidewall 234, the peripheral wall 236, and the frame 240 form a second partition 254, which is opposite to the first partition 252 according to the frame 240.

[0096] Actuation device 208 may include a connector 226 attached to housing 220 to form an internal region 258 between the inner surface of connector 226 and the outer surface of housing 220. This internal region 258 includes power and communication interface structures, such as a secondary coil 228 and antenna 230 hermetically sealed outside housing 220. Connector 226 is configured with a dielectric or insulating material (such as a radome) to allow the transmission of power and communication signals between antenna 230 and a handheld programmer or charger, and between secondary coil 228 and the charger. For example, connector 226 may consist of an overmolded polymer attached to housing 220 and include the secondary coil 228 and antenna within internal region 258. In this example, secondary coil 228 and antenna 230 are made of a biocompatible material. In one example, secondary coil 228 and antenna 230 may be formed as coils from a stamped titanium core coated with gold or silver. In another example, secondary coil 228 and antenna 230 may be formed from gold wire.

[0097] Actuation device 208 includes an energy storage system (such as a rechargeable power supply 260 or a rechargeable battery) and electronic components 262 within a first partition 252. Electronic components 262 may be disposed on a circuit board 264, such as multiple circuit boards, within the first partition 252. The rechargeable battery 260 may take various forms suitable for providing power to generate desired electrical signals and storing power supplied from the electronic components 262. For example, battery 260 may operate the electronic components 262 using lithium-ion (Li+) chemistry (i.e., a lithium-ion battery). In one example, electronic components 262 may be implemented by various components including resistors, capacitors, transistors, and integrated circuits disposed on the circuit board 264. Secondary coil 228 and antenna 230 are electrically coupled to the electronic components 262 within the first partition 252, such as via an hermetically sealed feedthrough.

[0098] Electronic component 262 may include a recharging system, a communication system, and a controller. The recharging system includes hardware configured to interface with secondary coil 228 to receive power signals and provide power signals in a manner suitable for recharging battery 260, and may include circuitry to reduce the likelihood of overcharging battery 260. The communication system includes hardware configured to interface with antenna 230 to receive electrical communication signals. For example, the communication system may be configured to communicate via wireless personal area network technologies such as Bluetooth Low Energy, which are compatible with various operating systems that can be applied to mobile devices configured as handheld programmers. The communication system may include integrated circuits to implement the applied communication technology. In some examples, the communication system may be used to transmit communication signals to other devices, such as chargers or handheld programmers, and the communication system may be implemented to generate and provide communication signals to antenna 230 for transmission. In some examples, the communication system may be configured to receive and transmit radio frequency signals via antenna 230. The controller may include a microcontroller to operate the recharging system and to receive and operate in response to communication signals, or to generate communication signals from the communication system.

[0099] The actuation device 208 also includes a fluid circuit 270 within a second compartment 254, which is opposite the battery 260 and electronic components 262 according to the frame 240. In this example, the frame 240 may include an opening 242 including a hermetically sealed interface 244, such as a feedthrough hermetically attached to the frame. The electronic components 262 are operatively coupled to the fluid circuit 270 via the hermetically sealed interface 244 through the frame 240. For example, a controller of the electronic components 262 powered by the battery 260 may cause operation of the fluid circuit 270 to control and monitor the fluid circuit 270. The fluid circuit 270 includes a manifold 272 and a fluid component 274 operatively coupled to the manifold 272. In the illustrated example, the manifold 272 is a structure integrated into the frame 240 such that the manifold 272 and the frame 240 together form a hermetically sealed barrier between the first compartment 252 and the second compartment 254 of the internal compartment 250. For example, battery 260, circuit board 264 or electronic component 262 may be coupled to a first main surface of manifold 272 in first partition 252, and fluid component 274 may be operatively coupled to the opposite second main surface of manifold 272 in second partition 254.

[0100] Fluid loop 270 is arranged in a fluid architecture, such as in the example shown. Figure 3B The fluid architecture 330 includes a fluid loop 270 that provides transfer of fluid 206 between a reservoir 204 and an expandable component, such as a cylinder 202. A manifold 272 may be an airtight manifold that divides and contains fluid from an internal compartment 250 to reduce the chance of fluid exchange and directs fluid from a first port 276 to a second port 278 via an internal fluid passage or pathway. In the example shown, the fluid component 274 includes multiple fluid pumps (such as pumps 280, 282) and a valve 284 mounted in the manifold 272 in fluid communication with the manifold passage to transfer fluid from the first port 276 to the second port 278. In the example of fluid architecture 330, the pumps and valve are in fluid communication with a single fluid passage between ports 276, 278. The fluid component 274 also includes a pressure sensor 286 operatively coupled to the manifold 272 and in fluid communication with the passage to detect the pressure of the fluid within the manifold 272. As indicated, fluid components 274 are included in a planar configuration on manifold 272, wherein pumps 280, 282, valve 284, and pressure sensor 286 are mounted planarly in a slim profile within second partition 254. Manifold 272 may include chambers 288 formed in a second main surface, in which the chambers are fluidly coupled to a single channel within manifold 272. These chambers are configured to receive pumps 280, 282, valve 284, and pressure sensor 286. Manifold 272 may receive piezoelectric pumps, such as… Figures 5A-5COr the pump shown in 6A-6C. Manifold 272 may receive component cover 290 on fluid component 274, which component cover 290 may be hermetically sealed to the second main surface.

[0101] An exemplary actuation device 208 may include an anti-twist tube 292 that may extend through a connector 226 and be attached to ports 276, 278 via components such as barbs 294 and O-rings. The anti-twist tube 292 may be attached to conduits 210, 212 to fluidly couple the actuation device 208 to a reservoir 204 and an expandable member (such as cylinder 202).

[0102] Figure 8 Another actuation device 808 is shown, which can be combined with Figure 2 Instead of the actuation device 208, the implantable medical device 200 may be included. For example, alternative implantable medical devices may include expandable components (such as a pair of expandable cylinders 202), a reservoir 204 that can be filled with fluid (such as a sterile saline solution 206), and an electromechanical actuation device 808 in a closed system. The reservoir 204 is fluidly coupled to the actuation device 808 via conduit 210, and the actuation device 808 is fluidly coupled to the cylinders 202 via conduit 212.

[0103] The actuation device 808 includes a hermetically sealed housing 820 formed of a biocompatible material, such as titanium or steel. In one example, the housing 820 is formed via multiple walls welded together. The actuation device 808 includes an internal fluid circuit to fluidly couple a reservoir 204 to a cylinder 202 via conduits 210, 212. Internal electronics powered by a rechargeable power source can provide monitoring and control of various operations of the fluid circuit, such as the transfer of fluid 206 between the reservoir 204 and the cylinder 202. In one example, the electromechanical actuation device 808 can be coupled with… Figure 1 Corresponding to implantable medical device 30. Housing 820 forms an internal compartment defined by a space within actuator 808, which is further defined by a plurality of walls. Actuator 808 may include connector 826 to form an area including power and communication interface structures such as secondary coil 828 and antenna 830. Connector 826 is configured to allow the transmission of power and communication signals between antenna 830 and a handheld programmer or charger, and between secondary coil 828 and charger.

[0104] Figure 9 It shows Figure 8An exploded view of an exemplary actuation device 808, wherein like parts are labeled with the same reference numerals. The housing 820 includes a first sidewall 832, an opposing second sidewall 834, a third sidewall 836 (adjacent to the first sidewall 832), a fourth sidewall 838 (opposite to the third sidewall 836), and a frame 840. In the exemplary actuation device 808, the sidewalls 832, 834, 836, and 838 are hermetically sealed together to form an internal compartment 850 within the housing 820. The frame 840 is disposed within the internal compartment 850, thereby forming a first partition 852 and a second partition 854 in a hermetically sealed manner relative to the second partition 854. In the example, the frame 840 is welded to the sidewalls 832, 834, 836, and 838. In the illustrated example, the first sidewall 832, the second sidewall 834, and the frame 840 form the first partition 852. The third sidewall 236, the fourth sidewall 838, and the frame 240 form a second partition 854, which is opposite to the first partition 852 according to the frame 840.

[0105] The actuation device 808 may include a connector 826 attached to a housing 820 to form an internal region 858 between an inner surface of the connector 826 and an outer surface of the housing 820. This internal region 858 includes a secondary coil 828 and an antenna 830, both located outside the hermetically sealed housing 820 within the internal region 858. The connector 826 is configured with a dielectric or insulating material (such as a radome) to allow the transmission of power and communication signals between the antenna 830 and a handheld programmer or charger, and between the secondary coil 828 and the charger. In this example, the secondary coil 828 and the antenna 830 are constructed of a biocompatible material.

[0106] Actuation device 808 includes an energy storage system (such as a rechargeable battery 860) and electronic components 862 within a first partition 852. Electronic components 862 may be disposed on a circuit board 864 (such as multiple circuit boards) within the first partition 852. A secondary coil 828 and an antenna 830 are electrically coupled to the electronic components 862 within the first partition 852, such as via an hermetically sealed feedthrough. Electronic components 862 may include a recharging system, a communication system, and a controller. The recharging system includes hardware configured to interface with the secondary coil 828 to receive power signals and to provide power signals in a manner suitable for recharging the battery 860, and may include circuitry to reduce the likelihood of overcharging the battery 860. The communication system includes hardware configured to interface with the antenna 830 to receive electrical communication signals. In some examples, the communication system may be used to send communication signals to other devices (such as a charger or handheld programmer), and the communication system may be implemented to generate and provide communication signals to the antenna 830 for transmission. The controller may include a microcontroller to operate the recharging system and to receive and operate in response to communication signals, or to generate communication signals from the communication system.

[0107] In another example, actuation devices 208, 808 may be constructed without connectors 226, 826, respectively, and the interface components of secondary coils 228, 828 or antennas 230, 830 are disposed within first partitions 252, 852 together with electronic components 262, 862. In this example, the sidewalls of housings 220, 820 may be manufactured to include hermetically sealed non-conductive windows. An example of such a window is proposed in U.S. Patent Application Serial No. 17 / 951,561, filed September 23, 2022, entitled “Device with Window for Wireless Power Transfer for Urology Implantable Devices,” which is incorporated herein by reference without contradiction to the extent that it is intended to be true. Alternatively, the actuation devices may be constructed without external communication or rechargeable features and may not include secondary coils and antennas.

[0108] The actuation device 808 also includes a fluid circuit 870 located within a second partition 854, which is opposite the battery 860 and electronic components 862 according to a frame 840. In this example, the frame 840 may include an opening 842 including a hermetically sealed interface 844, such as a feedthrough hermetically attached to the frame. The electronic components 862 are operatively coupled to the fluid circuit 870 across the frame 840 via the hermetically sealed interface 844. For example, a controller of the electronic components 862 powered by the battery 860 can cause operation of the fluid circuit 870, thereby controlling and monitoring the fluid circuit 870. The fluid circuit 870 includes a manifold 872 and a fluid component 874 operatively coupled to the manifold 872. The fluid circuit 870 is arranged in a fluid architecture, such as in the illustrated example. Figure 3A The fluid architecture 300. Fluid loop 870 provides for the transfer of fluid 206 between reservoir 204 and expandable components (such as cylinder 202). Manifold 872 may be an airtight manifold that divides and contains fluid from internal compartment 850 to reduce the chance of fluid exchange and guides fluid from first port 876 to second port 878 via internal fluid channels or pathways. In the example shown, manifold 872 and fluid component 874 are... Figure 4A and 4B The structural arrangement of the manifold 400.

[0109] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of this disclosure. For example, while the above embodiments relate to specific features, the scope of this disclosure also includes embodiments with different combinations of features and embodiments that do not include all of the stated features. Therefore, the scope of this disclosure is intended to include all such substitutions, modifications, and variations falling within the scope of the claims, as well as all their equivalents.

Claims

1. An implantable medical device, comprising: An outer casing forming an internal compartment, the outer casing including a frame disposed within the internal compartment, the frame forming a first partition and a second partition within the internal compartment, the first partition being hermetically sealed relative to the second partition; At least one electronic component and a power supply are disposed within the first partition; and A fluid circuit comprising a manifold operatively coupled to at least one fluid component, the fluid circuit being operatively coupled across the frame to the at least one electronic component.

2. The implantable medical device of claim 1, wherein the implantable medical device is included in an implantable urinary system device.

3. The implantable medical device according to claim 2, wherein the implantable urinary system device is an expandable penile prosthesis.

4. The implantable medical device according to any one of claims 2-3, wherein the implantable urinary system device comprises a reservoir having fluid, and the implantable medical device is in fluid communication with the reservoir.

5. The implantable medical device of claim 4, wherein the implantable urinary system device comprises a plurality of expandable cylinders to receive the fluid, and the implantable medical device is in fluid communication with the plurality of expandable cylinders, and wherein the implantable medical device is configured to pump the fluid from the reservoir to the plurality of expandable cylinders.

6. The implantable medical device according to any one of claims 1-5, wherein the implantable medical device is included in a medical system, the medical system further including a remote charger and a remote programmer.

7. The implantable medical device of claim 6, wherein the remote charger is operatively coupled to the interface system to provide transcutaneous inductive power transfer to the secondary conductor.

8. The implantable medical device according to any one of claims 6-7, wherein the programmer is a handheld programmer that communicates with a communication system via an antenna at radio frequency.

9. The implantable medical device of claim 8, wherein the programmer includes a software application operating on a mobile computing device to operate the implantable medical device.

10. The implantable medical device according to any one of claims 1-9, wherein the fluid circuit is operatively coupled to the at least one electronic component across the frame via an hermetically sealed feedthrough connector.

11. The implantable medical device according to any one of claims 1-10, wherein the manifold is integrally formed with the frame.

12. The implantable medical device of claim 11, wherein at least one electronic component is coupled to the manifold in the first partition.

13. The implantable medical device according to any one of claims 1-12, wherein the fluid component is arranged in a planar configuration.

14. The implantable medical device of claim 12, wherein the fluid component comprises two piezoelectric pumps in a single fluid passage.

15. The implantable medical device of claim 14, wherein the fluid component further comprises a valve and a pressure sensor in the single fluid passage.

16. An implantable medical device, comprising: An outer casing forming an internal compartment, the outer casing including a frame disposed within the internal compartment, the frame forming a first partition and a second partition within the internal compartment, the first partition being hermetically sealed relative to the second partition; At least one electronic component and a power supply are disposed within the first partition; and A fluid circuit comprising a manifold operatively coupled to at least one fluid component, the fluid circuit being operatively coupled across the frame to the at least one electronic component.

17. The implantable medical device of claim 16, wherein the power source is a rechargeable power source including a battery.

18. The implantable medical device of claim 17, wherein the electronic component includes a communication system and a recharging system, the recharging system being coupled to the power source.

19. The implantable medical device of claim 18, further comprising an antenna operatively coupled to the communication system and a secondary coil operatively coupled to the recharging system.

20. The implantable medical device of claim 19, wherein the antenna and secondary coil are disposed outside the internal compartment, wherein a connector is operatively coupled to the housing outside the internal compartment and forms an internal region, and the antenna and secondary coil are disposed within the internal region.

21. The implantable medical device of claim 16, wherein the manifold is integrally formed with the frame.

22. The implantable medical device of claim 21, wherein the manifold is hermetically sealed to the housing to form the first partition and the second partition.

23. The implantable medical device of claim 22, wherein at least one electronic component is coupled to the manifold in the first partition.

24. The implantable medical device of claim 16, wherein the fluid circuit is operably coupled to the at least one electronic component across the frame via an hermetically sealed feedthrough connector.

25. The implantable medical device of claim 16, wherein the fluid components are arranged in a planar configuration.

26. The implantable medical device of claim 25, wherein the fluid component comprises two piezoelectric pumps in a single fluid passage.

27. The implantable medical device of claim 26, wherein the fluid component further comprises a valve and a pressure sensor in the single fluid passage.

28. The implantable medical device of claim 16, wherein the fluid components are arranged in a stacked configuration.

29. A method of manufacturing an implantable medical system, the method comprising: A frame is formed including a fluid manifold having a first main surface and a second main surface; At least one electronic component and a power supply are operatively coupled to the first main surface; At least one fluid component is operatively coupled to the second main surface to form a fluid circuit; The outer shell is attached to the frame to form an internal compartment, wherein the frame defines a first partition and a second partition of the internal compartment, the first partition being hermetically sealed relative to the second partition; as well as The at least one electronic component is operatively coupled to the fluid circuit across the frame.

30. The method of claim 29, further comprising forming a channel within the fluid manifold and a chamber in the second main surface, the chamber being fluidly coupled to the channel, wherein the at least one fluid component is operatively coupled to the chamber.

31. The method of claim 29, wherein the manifold is integrally formed with the frame.

32. An implantable urinary system device, comprising: A reservoir configured to receive fluid; An expandable component that is in fluid communication with the reservoir; Implantable medical actuation devices, including: An outer casing forming an internal compartment, the outer casing including a frame disposed within the internal compartment, the frame forming a first partition and a second partition within the internal compartment, the first partition being hermetically sealed relative to the second partition; At least one electronic component and a power supply are disposed within the first partition; and A fluid circuit comprising a manifold operatively coupled to at least one fluid component, the fluid circuit being operatively coupled to the electronic component across the frame.

33. The implantable urinary system device of claim 32, wherein the expandable member comprises a plurality of expandable cylinders in fluid communication with the medical actuation device and the reservoir, the plurality of expandable cylinders being configured to be disposed within the corpora cavernosa of the penis.

34. The implantable urinary system device of claim 32, wherein the medical device is configured to be disposed in the retropubic space.

35. The implantable urinary system device of claim 32, wherein the manifold is integrally formed with the frame.

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