Electronic pump assembly for an implantable device having a flow modifier - Patents.com

Abstract

An electronic pump assembly including a pump configured to move fluid between or to fluid reservoirs of a device, the pump including a passive valve, a controller configured to operate the pump, and a flow modifier configured to restrict the flow of fluid into or within the pump.

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 / 183,708, entitled “AN ELECTRONIC PUMP ASSEMBLY FOR AN IMPLANTABLE DEVICE HAVING A FLOW MODIFIER,” filed March 14, 2023, which claims priority to U.S. Provisional Patent Application No. 63 / 269,446, entitled “AN ELECTRONIC PUMP ASSEMBLY FOR AN IMPLANTABLE DEVICE HAVING A FLOW MODIFIER,” filed March 16, 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 / 269,446, filed March 16, 2022, the disclosure of which is incorporated by reference in its entirety herein.

[0003] This disclosure relates generally to body implants, and more particularly to body implants such as electronic implantable devices having electronic-based pumps and flow modifiers for increasing the efficiency of the electronic-based pumps. [Background technology]

[0004] Implantable devices may include electronic-based pumps for transferring fluids between components of the implantable device, however, some conventional electronic-based pump designs may have pumping inefficiencies with respect to transferring fluids between components of the implantable device. Summary of the Invention [Means for solving the problem]

[0005] According to an aspect, an electronic pump assembly includes a pump configured to move fluid between or to fluid reservoirs of a device, the pump including a passive valve, a controller configured to operate the pump, and a flow modifier configured to restrict the flow of fluid into or within the pump.

[0006] The electronic pump assembly may include one or more (or any combination thereof) of the following features: The flow modifier includes a filter disposed in a fluid passage connected to the pump. The filter is a first filter connected to an inlet of the pump, and the electronic pump assembly includes a second filter connected to an outlet of the pump. The filter includes a tubular member defining a cavity, and the filter includes a filter component disposed in the cavity of the tubular member and defining a plurality of holes. The plurality of holes include linear holes. The plurality of holes include conical holes. The filter component includes a cylindrical portion having a first end portion and a second end portion, the first end portion including a flat surface, and the second end portion including a conical portion. The flow modifier is defined by at least a portion of a passive valve. The pump includes a piezoelectric element, a diaphragm actuator, and a base plate defining an inlet port and an outlet port. The pump includes a first layer of material defining a first passive valve and a second layer of material defining a second passive valve, the first and second layers of material being disposed between the diaphragm actuator and a base plate.

[0007] According to an aspect, an implantable device includes a fluid reservoir configured to hold a fluid, an expandable member, and an electronic pump assembly configured to transfer fluid between the fluid reservoir and the expandable member. The electronic pump assembly includes a pump configured to move fluid from or to the fluid reservoir of the device and including a first passive valve and a second passive valve, a controller configured to operate the pump, and a flow modifier configured to restrict the flow of fluid into or within the pump.

[0008] According to some embodiments, the implantable device may include one or more of the following features: The flow modifier includes a filter disposed in a fluid passage connected to the pump. The filter includes a tubular member defining a cavity, the filter includes a cylindrical member disposed in the cavity of the tubular member and defining a plurality of holes. The plurality of holes includes circular holes, Y-shaped holes, hexagonal holes, honeycomb holes, or holes arranged in a spiral lattice. The flow modifier is defined by at least a portion of a passive valve. The pump includes a piezoelectric element, a diaphragm actuator, and a base plate defining an inlet port and an outlet port. The pump includes a first layer of material defining a first passive valve and a second layer of material defining a second passive valve, the first and second layers of material being disposed between the diaphragm actuator and the base plate. At least one of the first layer of material or the second layer of material is harder than a material of the diaphragm actuator.

[0009] According to an aspect, a method of controlling an implantable device includes detecting a signal to actuate a pump of an electronic pump assembly, the pump including a piezoelectric pump having a passive valve, transferring fluid from a fluid reservoir with the pump, and restricting the flow of fluid into the pump with a flow modifier. In some examples, the flow modifier is disposed in a fluid passageway between the fluid reservoir and the pump. [Brief description of the drawings]

[0010] [Figure 1A] FIG. 1 illustrates a device having a pump and a flow modifier according to an embodiment. [Figure 1B] FIG. 1 illustrates an example of a flow modifier according to an aspect. [Figure 2A] FIG. 1 illustrates an example of a pump, according to an embodiment. [Figure 2B] FIG. 1 illustrates an example of a pump having an inlet check valve in an open position and an outlet check valve in a closed position according to an embodiment. [Figure 2C] FIG. 1 illustrates an example of a pump having an inlet check valve in a closed position and an outlet check valve in a closed position according to an embodiment. [Figure 2D]1 illustrates an example of a pump having an inlet check valve in a closed position and an outlet check valve in an open position according to an embodiment. [Diagram 3] FIG. 13 depicts a pressure graph without a flow corrector according to an embodiment. [Figure 4] FIG. 13 depicts a pressure graph with a flow modifier according to an embodiment. [Figure 5A] 13A-13D illustrate an inflatable device having a filter in a fluid passage between a pump and a fluid reservoir, according to an embodiment. [Figure 5B] 1A-1D illustrate examples of inflatable devices according to an embodiment. [Figure 6] 1 illustrates an inflatable device according to an embodiment. [Figure 7] FIG. 1 illustrates an example of a filter according to an aspect. [Figure 8] FIG. 1 illustrates a filter component defining a plurality of pores according to an embodiment. [Figure 9] FIG. 1 illustrates a filter component defining a plurality of pores according to an embodiment. [Figure 10A] FIG. 1 illustrates an example of a filter according to an aspect. [Figure 10B] 1A-1C illustrate examples of filter components defining a plurality of pores, according to an embodiment. [Figure 11A] FIG. 1 illustrates an example of a filter according to an aspect. [Figure 11B] 1A-1C illustrate examples of filter components defining a plurality of pores, according to an embodiment. [Figure 12A] 1A-1C illustrate examples of filter components defining a plurality of pores, according to an embodiment. [Figure 12B] FIG. 1 is a perspective view of a filter component according to an embodiment. [Figure 12C] FIG. 13 is another perspective view of a filter component according to an embodiment. [Figure 12D] FIG. 13 is another perspective view of a filter component according to an embodiment. [Figure 12E] FIG. 13 is another perspective view of a filter component according to an embodiment. [Figure 13] FIG. 1 illustrates an example of a filter according to an aspect. [Figure 14A]1A-1C show examples of filter pores according to an embodiment. [Figure 14B] FIG. 13 is another perspective view of a filter component according to an embodiment. [Figure 14C] FIG. 13 is another perspective view of a filter component according to an embodiment. [Figure 14D] FIG. 13 is another perspective view of a filter component according to an embodiment. [Figure 15] FIG. 1 illustrates an example of an inflatable penile prosthesis according to an embodiment. [Figure 16] FIG. 1 illustrates an example of an artificial urinary sphincter device, according to an embodiment. [Figure 17] 1 is a flow chart illustrating example operations for controlling an implantable device according to an aspect. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The present disclosure relates to an electronic pump assembly for a device (e.g., an implantable device). The electronic pump assembly includes one or more pumps (e.g., electronic-based pumps) and a flow modifier that can increase the pumping efficiency of the pump. In some examples, the pump includes one or more passive valves, and the flow modifier is configured to increase the efficiency in opening and closing the passive valves, thereby increasing the pumping efficiency of the pump. In some examples, there may be a loss in efficiency of the pump due to the amount of time (e.g., longer time) to open and close the passive valves and / or vibration effects in the fluid system. However, the flow modifier is configured to increase the pump efficiency by reducing the amount of time to open and close the passive valves and reducing the effects of vibrations on the pumping mechanism.

[0012] In some examples, the device is an artificial urinary sphincter device. In some examples, the device is an inflatable penile prosthesis. The implantable device can include an inflatable member, an electronic pump assembly, and a fluid reservoir. The electronic pump assembly can transfer fluid between the fluid reservoir and the inflatable member without a user manually activating the pump bulb. For example, the transfer of fluid between the inflatable member and the fluid reservoir is electrically controlled. In some examples, the implantable device is a drug pump, such as an insulin pump or a pain management drug pump, including a piezoelectric (or other type) pump.

[0013] In some examples, the pump includes a piezoelectric diaphragm pump that can include a piezoelectric element, a diaphragm actuator coupled to the piezoelectric element, and a base plate that defines an inlet port and an outlet port. The pump includes one or more passive valves (e.g., check valves) that can include one or more layers of material that define a ring member (e.g., an O-ring). In some examples, the layers of material that define the ring member can be disposed between the diaphragm actuator and the base plate. When the passive valve is closed, a flow path is obstructed by an interface between the diaphragm actuator and the ring member, thereby closing the flow path. Fluid can flow when the diaphragm actuator is released from the ring member.

[0014] In some examples, the flow modifier includes a filter disposed in a fluid passage connected to the pump. The flow modifier is configured to restrict the flow of fluid into the pump. In some examples, the flow modifier is disposed in a fluid passage between the fluid reservoir and the pump. In some examples, the electronic pump assembly includes a plurality of filters, for example, a first filter disposed between the fluid reservoir and the pump (e.g., connected to an inlet of the pump) and a second filter disposed between the pump and the inflatable member (e.g., connected to an outlet of the pump). In some examples, the filter includes a tubular member and a filter member (e.g., a disk member or a cylindrical member) disposed within the tubular member and defining a plurality of holes. In some examples, the filter member (e.g., a disk member or a cylindrical member) includes a first end portion and a second end portion. In some examples, the first end portion includes a first portion (e.g., a flat surface). In some examples, the second end portion includes a conical portion (e.g., a conical surface). In some examples, the holes in the disk member include linear holes. In some examples, the holes in the disk member include conical holes. In some examples, the holes in the disk member include Y-shaped holes, honeycomb holes, hexagonal holes, or holes arranged in a spiral lattice. In some examples, the sum of the areas of the holes is substantially the same as the area of ​​the filter member.

[0015] In some examples, the flow modifier is defined by one or more materials of the passive valve. In some examples, the materials of the passive valve can have different material properties or dimensions to allow for a stiffer valve. For example, the materials of the passive valve can be comprised of a material that includes a higher hardness than other materials of the pump (e.g., the material of the diaphragm actuator). In some examples, the materials of the passive valve can have a thickness that is greater than the thickness of other materials of the pump (e.g., the material of the diaphragm actuator). In some examples, the passive valve includes spiral valves, the diameters of which can vary (e.g., different from one another) and / or be asymmetrical to vary the flow rate.

[0016] 1A and 1B show a device 100 having an electronic pump assembly 106 according to an embodiment. In some examples, the device 100 is a medical device. In some examples, the device 100 is an implantable device such as an artificial urinary sphincter device, an inflatable penile prosthesis, or a drug pump (e.g., an insulin pump or a pain management drug pump). In some examples, the device 100 is not implanted in the patient's body. The electronic pump assembly 106 is configured to transfer fluid from the fluid reservoir 102. In some examples, the fluid is a liquid-phase fluid such as a saline fluid. In some examples, the fluid is a gas (e.g., a pressurized gas). In some examples, the electronic pump assembly 106 is configured to transfer fluid between the fluid reservoir 102 and the inflatable member 104 (e.g., an inflatable cuff, an inflatable cylinder). In some examples, the electronic pump assembly 106 does not include an inflatable member, in which case the electronic pump assembly 106 is configured to transfer fluid from the fluid reservoir to a body part of the patient.

[0017] The electronic pump assembly 106 includes a controller 114, a battery 116, a pump 120 having a passive valve 121, and a flow modifier 145 that can increase the pumping efficiency of the pump 120. The flow modifier 145 is configured to increase the efficiency in opening and closing the passive valve 121, thereby increasing the pumping efficiency of the pump 120. In some examples, there may be a loss in efficiency of the pump (e.g., an electronic-based pump) due to the amount of time (e.g., longer time) to open and close the passive valve 121 and / or vibration effects in the fluid system. However, the flow modifier 145 is configured to increase the pump efficiency by reducing the amount of time to open and close the passive valve 121 and reducing the effects of vibrations on the pumping mechanism.

[0018] In some examples, the pump 120 includes a piezoelectric diaphragm pump that can include a piezoelectric element, a diaphragm actuator coupled to the piezoelectric element, and a base plate that defines an inlet port and an outlet port. The pump 120 includes one or more passive valves 121 that can include one or more layers of material that define a ring member (e.g., an O-ring). In some examples, the layers of material that define the ring member can be disposed between the diaphragm actuator and the base plate. Upon closing of the passive valve 121, a flow path is obstructed by an interface between the diaphragm actuator and the ring member, thereby closing the flow path. Fluid can flow when the diaphragm actuator is released from the ring member.

[0019] 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 a one-way pump that can transfer fluid from the fluid reservoir 102 to the inflatable member 104 (or from the inflatable member 104 to the fluid reservoir 102). In some examples, the pump 120 is a two-way pump that can transfer fluid from the fluid reservoir 102 to the inflatable member 104 and from the inflatable member 104 to the fluid reservoir 102.

[0020] In some examples, the pump 120 is an electromagnetic pump that uses electromagnetism to move fluid between the fluid reservoir 102 and the expandable member 104. With an electromagnetic pump, a magnetic field is set at an angle to the direction the fluid is moving and an electric current is applied.

[0021] 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 a 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 with 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 a non-mechanical (e.g., no moving parts) pump.

[0022] The passive valve 121 may be defined by one or more materials within the pump 120. The passive valve 121 may allow (or prevent) fluid to flow into (or out of) a fluid chamber of the pump 120. In some examples, the passive valve 121 includes a spiral valve. The passive valve 121 may transition between an open position (fluid flows through the passive valve 121) and a closed position (fluid is prevented from flowing through the passive valve 121) depending on the presence or absence of an external force. For example, an external force (e.g., a fluid) may be used to open or close the passive valve 121, in which case the passive valve 121 may not be actuated unless there is a flow of fluid around and through the pump chamber of the pump 120.

[0023] The passive valve 121 can assist in maintaining pressure within the expandable member 104. In some examples, the pump 120 can include a single passive valve 121. In some examples, the pump 120 can include multiple passive valves 121, such as two passive valves or three or more passive valves 121. The passive valve 121 may not be directly controlled by the controller 114 and may instead be based on the pressure between the expandable member 104 and the fluid reservoir 102. The passive valve 121 can transition between an open position (fluid is permitted to flow through the passive valve 121) and a closed position (fluid is prevented from flowing through the passive valve 121). In some examples, the passive valve 121 transitions to a closed position in response to a positive pressure between the expandable member 104 and the fluid reservoir 102. In some examples, the passive valve 121 transitions to an open position in response to a negative pressure between the expandable member 104 and the fluid reservoir 102.

[0024] In some examples, the flow modifier 145 is disposed in the fluid passage 117 connected to the pump 120. The flow modifier 145 is configured to restrict the flow of fluid into the pump 120. In some examples, the flow modifier 145 is disposed in the fluid passage 117 between the fluid reservoir 102 and the pump 120. In some examples, the electronic pump assembly 106 includes multiple flow modifiers 145, for example, a first flow modifier 145 disposed in the fluid passage 117 between the fluid reservoir 102 and the pump 120 (e.g., connected to an inlet of the pump 120) and a second flow modifier 145 disposed in the fluid passage 119 between the pump 120 and the expandable member 104 (e.g., connected to an outlet of the pump 120).

[0025] 1B , in some examples, the flow modifier 145 includes a tubular member 156 and a filter member 158 disposed within a cavity of the tubular member 156. In some examples, the filter member 158 includes a disk member. In some examples, the filter member 158 includes a cylindrical member. In some examples, the filter member 158 is disposed in a central region within the cavity of the tubular member 156. The tubular member 156 can be disposed within the fluid passage 117 and / or the fluid passage 119.

[0026] The filter member 158 includes a first end portion 162 and a second end portion 164. In some examples, the first end portion 162 includes a flat surface. In some examples, the first end portion 162 includes a curved portion. In some examples, the first end portion 162 includes a conical portion. In some examples, the second end portion 164 includes a conical portion. The filter member 158 defines a plurality of pores 160. The pores 160 can extend between the first end portion 162 and the second end portion 164. The pores 160 can be through holes extending through the filter member 158. In some examples, the pores 160 include linear pores (e.g., straight pores). In some examples, the pores 160 include conical pores. In some examples, the pores 160 include y-shaped pores. In some examples, the pores 160 include hexagonal pores or honeycomb pores. In some examples, the filter member 158 defines pores 160 in a spiral lattice (e.g., a structure having channels in multiple directions). In some examples, the sum of the areas of the pores 160 is substantially the same as the area of ​​the filter member 158. In some examples, the sum of the areas of the pores 160 is substantially the same as the area of ​​the tubular member 156.

[0027] In some examples, the flow modifier 145 is defined by one or more materials of the passive valve 121. In some examples, the materials of the passive valve 121 can have different material properties or dimensions to allow for a stiffer valve. For example, the materials of the passive valve 121 can be comprised of a material that includes a higher hardness than other materials of the pump 120 (e.g., the material of the diaphragm actuator). In some examples, the materials of the passive valve 121 can have a thickness that is greater than the thickness of other materials of the pump 120 (e.g., the material of the diaphragm actuator). In some examples, the passive valve 121 includes multiple helical valves, the diameters of which can vary (e.g., different from one another) and / or be asymmetrical to vary the flow rate.

[0028] 2A-2D show examples of pump 220. Pump 220 can be a piezoelectric diaphragm pump. In some examples, pump 220 is a cymbal type piezoelectric pump. In some examples, pump 220 can include any type of piezoelectric actuator (e.g., temperature-based, pneumatic-based, and / or electromagnetic, etc.) that could be used to actuate a diaphragm. Pump 220 includes a piezoelectric element 266 configured to receive a voltage from controller 114, a diaphragm actuator 268 coupled to piezoelectric element 266, and a base plate 274 defining an inlet port and an outlet port. In some examples, piezoelectric element 266 has a disk shape with a diameter smaller than the diameter of diaphragm actuator 268. In some examples, diaphragm actuator 268 has a disk shape. In some examples, diaphragm actuator 268 includes a metal-based material. In some examples, diaphragm actuator 268 includes a titanium diaphragm. In some examples, base plate 274 has a disk shape. The base plate 274 defines an inlet port extending through its thickness. The base plate 274 defines an outlet port extending through its thickness. The thickness of the base plate 274 can be greater than the thickness of the piezoelectric element 266 and the diaphragm actuator 268. In some examples, the base plate 274 has substantially the same diameter as the diaphragm actuator 268 (e.g., within 2 mm).

[0029] The pump 220 includes a layer of material 270 defining a passive valve 221-1 (e.g., an inlet check valve) and a layer of material 272 defining a passive valve 221-2 (e.g., an outlet check valve). The layers of material 270 and 272 can be titanium. The layers of material 270 and 272 can have a disk shape. The layers of material 270 and 272 can have substantially the same diameter (e.g., within 2 mm) as the base plate 274 and / or the diaphragm actuator 268. The layer of material 270 can define one or more helical slots that form the passive valve 221-1. The passive valve 221-1 can be disposed over an inlet port of the base plate 274. The layer of material 272 can define one or more helical slots that form the passive valve 221-1. The passive valve 221-2 can be disposed over an outlet port of the base plate 274.

[0030] FIG. 2B illustrates pump 220 in a feed mode in which fluid is pumped into fluid chamber 271 when piezoelectric element 266 bends diaphragm actuator 268 upward. While fluid is entering fluid chamber 271, passive valve 221-1 (e.g., inlet check valve) is open and passive valve 221-2 (e.g., outlet check valve) is closed. FIG. 2C illustrates pump 220 when both passive valves 221-1 and 221-2 are closed (e.g., when fluid chamber 271 is full) at the end of feed mode. FIG. 2D illustrates pump 220 in a pump mode in which fluid is expelled from fluid chamber 271 when piezoelectric element 266 bends diaphragm actuator 268 downward. For example, during pump mode, passive valve 221-1 is closed and passive valve 221-2 is open to allow fluid to flow out of fluid chamber 271.

[0031] FIG. 3 shows a pressure graph 300 depicting pressure during a pumping cycle when the electronic pump assembly does not include a flow modifier. For example, the feed mode begins at element 301 where the pump has the pump configuration of FIG. 2B and ends at element 303 where the pump has the pump configuration of FIG. 2C. The pump mode begins after the feed mode, and at element 305 during the pump mode, the pump has the pump configuration of FIG. 2D. In the feed mode, the diaphragm actuator displaces upwards and draws fluid into the pump. As shown in FIG. 3, there is a downward dip in the pressure graph, which is the closing of the outlet valve (e.g., passive valve 221-1) and is characterized by a steep increase followed by a decrease in the slope of the pressure graph. Once the maximum pressure is reached, the piezoelectric element and the diaphragm actuator begin to weaken the feed drive to expel fluid from the pump. The downward slope is a short slope until the inlet valve (passive valve 221-1) closes, allowing the force of the piezoelectric element to act to expel fluid from the pump and induce a steeper slope on the pressure graph. However, as shown in Figure 3, inefficiencies in the pump result from the time it takes to close both valves during a stroke.

[0032] Figure 4 shows a pressure graph 400 depicting the pressure of a pump during a pumping cycle when the electronic pump assembly includes a flow modifier. Element 401 depicts a pump having the pump configuration of Figure 2B, element 403 depicts a pump having the pump configuration of Figure 2C, and element 405 depicts a pump having the pump configuration of Figure 2D. As shown in Figure 4, the irregular portions of the pressure graph 300 of Figure 3 have been smoothed out, thereby increasing the efficiency of the pump.

[0033] 5A and 5B illustrate an implantable device 500 having an electronic pump assembly 108 according to an embodiment. The implantable device 500 may be an example of the device 100 of FIGS. 1A and 1B and may include any of the details discussed with reference to those figures. Similarly, the implantable device 500 includes one or more pumps 520. The pumps 520 may be an example of the pumps 120 of FIGS. 1A and 1B and / or the pumps 220 of FIGS. 2A-2D and may include any of the details discussed with reference to those figures.

[0034] Implantable device 500 can include a fluid reservoir 502, an expandable member 504, and an electronic pump assembly 506 configured to transfer fluid between fluid reservoir 502 and expandable member 504. In some examples, implantable device 500 is an artificial urinary sphincter device. In some examples, implantable device 500 is an inflatable penile prosthesis. However, implantable device 500 can include any type of medical device that transfers fluid between its components.

[0035] In some examples, the inflatable member 504 is an inflatable cuff member configured to be implemented around the patient's urethra. In some examples, the inflatable member 504 is a penile inflatable member (e.g., one or more inflatable cylinders) that can be implanted within the user's corpus cavernosum. In some examples, the fluid reservoir 502 can be implanted within the user's abdominal or pelvic cavity (e.g., the fluid reservoir 502 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 506 can be implemented within the patient's body.

[0036] The fluid reservoir 502 may include a container having an internal chamber configured to hold or contain a fluid used to inflate the expandable member 504. The volumetric capacity of the fluid reservoir 502 may vary depending on the size of the implantable device 500. In some examples, the volumetric capacity of the fluid reservoir 502 may be between 3 cubic centimeters and 150 cubic centimeters. In some examples, the fluid reservoir 502 is composed of the same material as the expandable member 504. In other examples, the fluid reservoir 502 is composed of a different material than the expandable member 504. In some examples, the fluid reservoir 502 contains a larger volume of fluid than the expandable member 504.

[0037] The implantable device 500 may include a first conduit connector 503 and a second conduit connector 505. The first conduit connector 503 and the second conduit connector 505 may each define a lumen configured to transfer fluid to and from the pump assembly 506. The first conduit connector 503 may be coupled to the electronic pump assembly 506 and the fluid reservoir 502 such that fluid may be transferred therethrough between the electronic pump assembly 506 and the fluid reservoir 502. For example, the first conduit connector 503 may define a first lumen configured to transfer fluid between the electronic pump assembly 506 and the fluid reservoir 502. The first conduit connector 503 may include a single or multiple tubing members for transferring fluid between the electronic pump assembly 506 and the fluid reservoir 502.

[0038] The second conduit connector 505 may be coupled to the pump assembly 506 and the expandable member 504 such that fluid may be transferred between the electronic pump assembly 506 and the expandable member 504 through the second conduit connector 505 .

[0039] The electronic pump assembly 506 and the expandable member 504 are through a second conduit connector 505. For example, the second conduit connector 505 can define a second lumen configured to transfer fluid between the electronic pump assembly 506 and the expandable member 504. The second conduit connector 505 can include a single or multiple tubing members for transferring fluid between the electronic pump assembly 506 and the expandable member 504. In some examples, the first conduit connector 503 and the second conduit connector 505 can include a silicone rubber material. In some examples, the electronic pump assembly 506 can be directly connected to the fluid reservoir 502. The assembly 506 can automatically transfer fluid between the fluid reservoir 502 and the expandable member 504 without a user having to manually activate the pump (e.g., squashing and releasing the pump bulb). The electronic pump assembly 506 can monitor, control, and regulate the pressure within the expandable member 504. The electronic pump assembly 506 may include a controller 514, one or more active valves 518, one or more pumps 520, and a pressure sensor 530 (or multiple pressure sensors). The controller 514 may control the pump 520 and the active valve 518 to move fluid between the expandable member 504 and the fluid reservoir 502 to transition the expandable member 504 between an inflated state and a deflated state. The pressure sensor 530 may monitor the pressure of the expandable member 504. The controller 514 may receive pressure readings from the pressure sensor 530 and control the pump 520 and the active valve 518 to maintain and / or adjust the pressure of the expandable member 504. The controller 514 may send control signals to the pump 520 and the active valve 518 to inflate or deflate the expandable member 504. In some examples, control of the inflation and deflation states is based on a wireless signal 509 received from an external device 501 actuated by the patient (and the detected pressure of the expandable member 504 from the pressure sensor 530). For example, the patient can use the external device 501 to place the expandable member 504 in an inflated or deflated state, whereupon the external device 501 sends a wireless signal 509 to the controller 514.

[0040] The electronic pump assembly 506 includes a filter modification 545 disposed in the fluid passageway 517 between the pump 520 and the fluid reservoir 502. The filter modification 545 may be an example of the filter modification 145 of Figures 1A and 1B and may include any of the details discussed with reference to those figures.

[0041] The electronic pump assembly 506 can include a battery 516 configured to provide power to the controller 514 and other components thereon. In some examples, the battery 516 is a non-rechargeable battery. In some examples, the battery 516 is a rechargeable battery. In some examples, the electronic pump assembly 506 (or a portion thereof) (or the controller 514) is configured to be connected to an external charger to charge the battery 516. In some examples, the electronic pump assembly 506 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.

[0042] The electronic pump assembly 506 can include an antenna 512 configured to wirelessly transmit (and receive) a wireless signal 509 to (and from) the external device 501. The external device 501 can be any type of component capable of communicating with the electronic pump assembly 506. The external device 501 can be a computer, a smart phone, a tablet, a pendant, a key fob, etc. A user can control the implantable device 500 with the external device 501. In some examples, the user can inflate or deflate the expandable member 504 with the external device 501. For example, in response to a user initiating an inflation cycle with the external device 501 (e.g., selecting a user controller on the external device 501), the external device 501 can transmit a wireless signal 509 to the electronic pump assembly 506 (received through the antenna 512) to initiate an inflation cycle, and the controller 514 can control the active valve 518 and the pump 520 to inflate the expandable member 504 to a target inflation pressure. In some examples, the controller 514 can place the active valve 518 in a closed position and activate a pump to move fluid from the fluid reservoir 502 to the expandable member 504 .

[0043] In some examples, in response to a user initiating a deflation cycle with the external device 501 (e.g., selecting a user controller on the external device 501), the external device 501 can transmit a wireless signal 509 to the electronic pump assembly 506 (received through the antenna 512) to initiate a deflation cycle, and the controller 514 can control the active valve 518 (and in some examples the pump 520) to transfer fluid from the inflatable member 504 to the fluid reservoir 502. For example, the controller 514 can control the active valve 518 to move to an open position to allow fluid to be transferred from the inflatable member 504 to the fluid reservoir 502. In some examples, the controller 514 can control the one or more pumps 520 to further transfer fluid from the inflatable member 504 to the fluid reservoir 502 during a deflation cycle. In some examples, during a deflation cycle, fluid is transferred back until the pressure in the inflatable member 504 reaches a partial inflation pressure. In some examples, the controller 514 can automatically decide to initiate a contraction cycle, which causes the controller 514 to control the active valve 518 (and in some examples the pump 520) to transfer fluid back to the fluid reservoir 502.

[0044] The controller 514 can be any type of controller configured to control the operation of the pump 520 and the active valve 518. In some examples, the controller 514 is a microcontroller. In some examples, the controller 514 includes one or more drivers configured to drive the pump 520 and the active valve 518. In some examples, the drivers are separate components from the controller 514. The controller 514 can be communicatively coupled to the active valve 518, the pump 520, and the pressure sensor 530. In some examples, the controller 514 is connected to the active valve 518, the pump 520, and the pressure sensor 530 through wired data lines. The controller 514 can include a processor 513 and a memory device 515.

[0045] The processor 513 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 513 can be semiconductor based, i.e., the processor can include semiconductor materials capable of executing digital logic. The memory device 515 can store information in a format that can be read and / or executed by the processor 513. The memory device 515 can store executable instructions that, when executed by the processor 513, cause the processor 513 to perform certain operations discussed herein. The controller 514 can receive data through the pressure sensor 530 and / or the external device 501 and control the active valve 518 and / or the pump 520 by sending control signals to the active valve 518 and / or the pump 520.

[0046] The memory device 515 can store control parameters that a user and / or physician can set or modify by using the external device 501. In some examples, the control parameters can include a target inflation pressure and / or a partial inflation pressure. In some examples, the target inflation pressure is the highest (or desired) pressure allowable in the expandable member 504. In some examples, the partial inflation pressure is a pressure threshold that can more closely mimic a user's natural experience and / or personal comfort. The user or physician can update the control parameters using the external device 501, which can be communicated to the controller 514 through the antenna 512, and then updated in the memory device 515.

[0047] The external device 501 can communicate with the electronic pump assembly 506 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.

[0048] In some examples, the electronic pump assembly 506 includes a single pump 520, such as pump 520-1. The pump 520-1 can be arranged in parallel with the active valve 518. In some examples, the electronic pump assembly 506 includes multiple pumps 520. For example, the pump 520 includes pump 520-1 and pump 520-2. In some examples, the pump 520-1 is arranged in a fluid passage 525 used to fill the inflatable member 504 (e.g., during an expansion cycle). In some examples, the pump 520-2 is arranged in a fluid passage 527 used to fill the inflatable member 504 (e.g., during an expansion cycle). In some examples, the pump 520-2 is arranged in parallel with the pump 520-1. The pump 520-1 can transport fluid according to a first flow rate, and the pump 520-1 can transport fluid according to a second flow rate. In some examples, the first flow rate is substantially the same as the second flow rate. In some cases, the first flow rate is different from the second flow rate.

[0049] In some examples, pump 520 can include more than two pumps 520, such as three, four, five, six, or seven or more pumps 520. For example, pump 520 can further include a third pump in parallel with pump 520-2, a fourth pump in parallel with the third pump, and the like. In some examples, pump 520 can include one or more pumps 520 in series with one or more other pumps 520. For example, one or more pumps 520 can be in series with pump 520-1. In some examples, one or more pumps 520 can be in series with pump 520-2.

[0050] Each pump 520 is an electronically controlled pump. Each pump 520 can be electronically controlled by the controller 514. For example, each pump 520 can be connected to the controller 514 and can receive a signal to operate the respective pump 520. The pumps 520 can be one-way pumps capable of transferring fluid from the fluid reservoir 502 to the inflatable member 504 (or from the inflatable member 504 to the fluid reservoir 502). In some examples, the pumps 520 are bi-directional pumps capable of transferring fluid from the fluid reservoir 502 to the inflatable member 504 and from the inflatable member 504 to the fluid reservoir 502. In some examples, the pumps 520 can be either one-way or bi-directional pumps. In some examples, the pumps 520 include a combination of one or more one-way pumps and one or more bi-directional pumps.

[0051] In some examples, pump 520 is an electromagnetic pump that uses electromagnetism to move fluid between fluid reservoir 502 and expandable member 504. For an electromagnetic pump, a magnetic field is set at an angle to the direction the fluid is moving and an electric current is applied.

[0052] In some examples, the pump 520 is a piezoelectric pump. In some examples, the piezoelectric pump can be a diaphragm micropump that uses actuation of a diaphragm to drive a 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 with multiple substrate layers of low voltage piezoelectric elements (e.g., stacked substrate layers). In some examples, the pump 520 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 520 is a non-mechanical (e.g., no moving parts) pump.

[0053] In some examples, in the case of multiple pumps 520, each pump 520 can be the same type of pump (e.g., all pumps 520 are electromagnetic pumps or all pumps 520 are piezoelectric pumps). In some examples, one or more pumps 520 are different from one or more other pumps 520. For example, pumps 520 can include different types of piezoelectric pumps or can include different types of electromagnetic pumps. Pump 520-1 can be a piezoelectric pump having a first number of micropumps and pump 520-2 can be a piezoelectric pump having a second number of micropumps (where the second number is different from the first number). Pump 520-1 can be an electromagnetic pump and pump 520-2 can be a piezoelectric pump.

[0054] As shown in FIG. 5B, the pump 520 can include one or more passive valves, such as passive valve 521-1 and passive valve 521-2. The passive valves can assist in maintaining pressure within the expandable member 504. In some examples, the pump 520 can include a single passive valve. In some examples, the pump 520 can include multiple passive valves, such as two passive valves or more than two passive valves. The passive valves of each pump 520 may not be directly controlled by the controller 514 and may be based on the pressure between the expandable member 504 and the fluid reservoir 502. The passive valves can transition between an open position (fluid is allowed to flow through the passive valve) and a closed position (fluid is prevented from flowing through the passive valve). In some examples, the passive valves transition to a closed position in response to a positive pressure between the expandable member 504 and the fluid reservoir 502. In some examples, the passive valve transitions to an open position in response to negative pressure between the expandable member 504 and the fluid reservoir 502 .

[0055] The electronic pump assembly 506 can include a single active valve 518. In some examples, the electronic pump assembly 506 includes multiple active valves 518. In some examples, one or more additional active valves 518 can be in series with the pump 520-1 and / or the pump 520-2. In some examples, the additional active valves 518 (e.g., the series active valve 518) can be disposed in the fluid passage 517 connected to the fluid reservoir 502. In some examples, the additional active valves 518 (e.g., the series active valve 518) can be disposed in the fluid passage 519 connected to the expandable member 504. These additional active valves 518 can reduce leakage when at full inflation pressure or partial inflation pressure.

[0056] The active valve 518 can be connected to the controller 514 of the electronic pump assembly 506 and can receive signals to transition the active valve 518 between an open position and a closed position. In some examples, the active valve 518 is disposed in a fluid passage 524 used to empty the expandable member 504 (e.g., in a deflation cycle). In some examples, the active valve 518 is disposed in a fluid passage 524 used to fill the expandable member 504 (e.g., in an inflation cycle). In some examples, the active valve 518 can be transitioned to a closed position to hold (e.g., substantially hold) pressure in the expandable member 504. In some examples, the active valve 518 can be transitioned to an open position to transfer fluid back to the fluid reservoir 502, to release pressure in the expandable member 504, and / or to allow backflow to the expandable member 504. In some examples, the active valve 518 can be used to hold (e.g., substantially hold) a partial inflation pressure.

[0057] In some examples, the electronic pump assembly 506 includes a sealed enclosure 508 that encloses its components. The sealed enclosure 508 can be an airtight (or substantially airtight) container. The sealed enclosure 508 can include one or more metal-based materials. In some examples, the sealed enclosure 508 is a titanium container. In some examples, the only material that is in contact with the patient is titanium. In some examples, the sealed enclosure 508 includes one or more non-metal-based materials (e.g., ceramics). In some examples, a portion of the sealed enclosure 508 is a metal-based material and a portion of the sealed enclosure 508 is a non-metal-based material. In some examples, the sealed enclosure 508 defines a penetration (e.g., a sealed penetration, an electrical penetration, a penetration connector, etc.) for receiving / transmitting wireless signals from / to the external device 501. In some examples, the penetration includes a metal-based material and an insulator-based material (e.g., ceramics).

[0058] FIG. 6 illustrates an example of an implantable device 600 according to another embodiment. The implantable device 600 may be an example of the device 100 of FIG. 1A and FIG. 1B and / or the implantable device 500 of FIG. 5A and FIG. 5B and may include any of the details discussed with reference to those figures. The implantable device 600 includes a fluid reservoir 602, an inflatable member 604, and an electronic pump assembly 606. The electronic pump assembly 606 includes an active valve 618, a pump 620-1, a pump 620-2, and a pressure sensor 630. The pump 620-1 includes a passive valve 621-1 and a passive valve 621-2. The pump 620-2 includes a passive valve 621-1 and a passive valve 621-2. Pump 620-1 and pump 620-2 may be examples of pump 220 of Figures 2A-2D and may include any of the details discussed with reference to those figures.

[0059] The electronic pump assembly 606 includes a flow modifier 645-1 disposed in the fluid path between the fluid reservoir 602 and the pumps 620-1, 620-2. The electronic pump assembly 606 includes a flow modifier 645-2 disposed in the fluid path between the expandable member 604 and the pumps 620-1, 620-2. The flow modifiers 645-1 and 645-2 may be examples of the flow modifiers 145 of Figures 1A and 1B and may include any of the details discussed with reference to those figures.

[0060] Figure 7 illustrates an example of a flow modifier 745 configured as a filter according to an embodiment. Flow modifier 745 may be an example of flow modifier 145 of Figures 1A and 1B, flow modifier 545 of Figures 5A and 5B, and / or flow modifier 645 of Figure 6, and may include any of the details discussed with reference to those figures.

[0061] The flow modifier 745 includes a tubular member 756 and a filter member 758 disposed within a cavity of the tubular member 756. In some examples, the filter member 758 includes a disk member. In some examples, the filter member 758 includes a cylindrical member. In some examples, the filter member 758 is disposed within a central region within the cavity of the tubular member 756.

[0062] The filter member 758 includes a first end portion 762 and a second end portion 764. In some examples, the first end portion 762 includes a flat surface. In some examples, the first end portion 762 includes a curved portion. In some examples, the first end portion 762 includes a conical portion. In some examples, the second end portion 764 includes a conical portion. The filter member 758 defines a plurality of holes 760. The holes 760 can extend between the first end portion 762 and the second end portion 764. The holes 760 can be through holes extending through the filter member 758. In some examples, the holes 160 include linear holes (e.g., straight holes), as shown in FIG. 7. In some examples, the holes 760 include conical holes. In some examples, the holes 760 include y-shaped holes. In some examples, the holes 760 include hexagonal holes or honeycomb holes. In some examples, the filter member 758 defines pores 760 in a spiral lattice (e.g., a structure having channels in multiple directions). In some examples, the sum of the areas of the pores 760 is substantially the same as the area of ​​the filter member 758. In some examples, the sum of the areas of the pores 760 is substantially the same as the area of ​​the tubular member 756.

[0063] Figure 8 shows a portion of a filter member 858 depicting straight or linear holes 860. Figure 9 shows a portion of a filter member 958 depicting conical holes 960.

[0064] 10A and 10B show a flow modifier 1045 having a tubular member 1056 and a filter member 1058 disposed within a cavity of the tubular member 1056. The filter member 1058 includes a first end portion 1062 and a second end portion 1064. The first end portion 1062 can include a flat surface. The second end portion 1064 can include a conical portion. FIG. 10B shows a portion of the filter member 1058. The filter member 1058 defines a plurality of holes 1060. In some examples, the holes 1060 are linear or straight holes.

[0065] 11A and 11B show a flow modifier 1145 having a tubular member 1156 and a filter member 1158 disposed within a cavity of the tubular member 1156. The filter member 1158 includes a first end portion 1162 and a second end portion 1164. The first end portion 1162 can include a flat surface. The second end portion 1164 can include a conical portion. FIG. 11B shows a portion of the filter member 1158. The filter member 1158 defines a plurality of holes 1160. In some examples, the holes 1160 include y-shaped holes.

[0066] Figures 12A-12E show a filter member 1258 defining a plurality of holes arranged in a helical lattice. In some cases, the helical lattice is a minimal surface structure that has channels in multiple directions that may trap fibers and particles in the structure. Figure 13 shows a flow modifier according to another embodiment. Figures 14A-14D show hexagonal or honeycomb holes.

[0067] FIG. 15 illustrates, in a schematic manner, an inflatable penile prosthesis 1500 having an electronic pump assembly 1506 according to an embodiment. The electronic pump assembly 1506 may include any of the features of the electronic pump assembly discussed herein. The inflatable penile prosthesis 1500 may include an inflatable member 1504 (e.g., a pair of inflatable cylinders 1510) configured to be implanted within the penis. For example, one of the inflatable cylinders 1510 may be disposed on one side of the penis and the other inflatable cylinder 1510 may be disposed on the other side of the penis. Each inflatable cylinder 1510 may include a first end portion 1524, a cavity or expansion chamber 1522, and a second end portion 1528 having a rear tip 1532.

[0068] At least a portion of the electronic pump assembly 1506 can be implanted in the patient's body. A pair of conduit connectors 1505 can attach the electronic pump assembly 1506 to the inflatable cylinder 1510 such that the electronic pump assembly 1506 is in fluid communication with the inflatable cylinder 1510. Similarly, the electronic pump assembly 1506 can be in fluid communication with the fluid reservoir 1502 through the conduit connector 1503. The fluid reservoir 1502 can be implanted in the abdomen of the user. The expansion chamber 1522 of the inflatable cylinder 1510 can be disposed in the penis. The first end portion 1524 of the inflatable cylinder 1510 can be disposed at least partially in the glans portion of the penis. The second end portion 1528 can be implanted in the patient's pubic region PR with the rear tip 1532 proximate to the pubic bone PB.

[0069] To implant the expandable cylinder 1510, the surgeon will first prepare the patient. Often, the surgeon will create an incision, for example, in the penoscrotal region 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 1510. The corpus cavernosum is the 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 back 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 1528. 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 1510 to be implanted.

[0070] After the patient is prepared, the inflatable penile prosthesis 1500 is implanted in the patient. The tip of the first end portion 1524 of each inflatable cylinder 1510 can be connected to a suture. The other end of the suture can be connected to a needle member (e.g., a Keith needle). The needle member is inserted into the incision and into the expanded corpus cavernosum. The needle member is then pushed firmly through the glans of the penis. The surgeon pulls the suture to draw the inflatable cylinder 1510 into the corpus cavernosum. This is done for each inflatable cylinder 1510 that constitutes a pair. Once the expansion chamber 1522 is in place, the surgeon can remove the suture from the tip. The surgeon then inserts the second end portion 1528. The surgeon inserts the rear end of the inflatable cylinder 1510 into the incision and pushes the second end portion 1528 firmly toward the pubic bone PB until each inflatable cylinder 1510 is in place.

[0071] A user can control the inflatable penile prosthesis 1500 using the external device 1501. In some examples, the user can inflate or deflate the inflatable cylinder 1510 using the external device 1501. For example, in response to a user initiating an inflation cycle using the external device 1501, the external device 1501 can transmit a wireless signal to the electronic pump assembly 1506 to initiate an inflation cycle and transfer fluid from the fluid reservoir 1502 to the inflatable cylinder 1510. In some examples, in response to a user initiating a deflation cycle using the external device 1501, the external device 1501 can transmit a wireless signal to the electronic pump assembly 1506 to initiate a deflation cycle and transfer fluid from the inflatable cylinder 1510 to the fluid reservoir 1502. In some examples, during a deflation cycle, fluid is transferred back until the pressure in the inflatable cylinder 1510 reaches a partial inflation pressure.

[0072] 16 illustrates a urethral control device 1600 having an electronic pump assembly 1606 according to an embodiment. The electronic pump assembly 1606 may include any of the features of the electronic pump assemblies discussed herein. The urethral control device 1600 includes a pump assembly 1606, a fluid reservoir 1602, and a cuff 1604.

[0073] The fluid reservoir 1602 may be a pressure-regulated inflation balloon or element. The fluid reservoir 1602 is in operative fluid communication with the cuff 1604 through one or more tubular members 1603, 1605. The fluid reservoir 1602 is comprised of a polymeric material capable of elastic deformation to reduce the fluid volume therein and expel the fluid therefrom into the cuff 1604. However, the material of the fluid reservoir 1602 may preferably be or include a shape memory structure adapted to maintain the fluid reservoir 1602 in a generally expanded state while having a relatively constant fluid volume and pressure. In some instances, this constant level of pressure exerted by the fluid reservoir 1602 on the cuff 1604 will keep the cuff 1604 in a desired inflated state when a fluid connection is provided between the fluid reservoir 1602 and the cuff 1604. This is primarily because only a small level of fluid displacement is required to inflate or deflate the cuff 1604. In some examples, the fluid reservoir 1602 is implanted within the abdominal space.

[0074] A user can control the urethral control device 1600 using the external device 1601. In some examples, the user can inflate or deflate the cuff 1604 using the external device 1601. For example, in response to a user initiating an inflation cycle using the external device 1601, the external device 1601 can send a wireless signal to the electronic pump assembly 1606 to initiate an inflation cycle to transfer fluid from the fluid reservoir 1602 to the cuff 1604 (e.g., by opening an active valve such that pressure in the fluid reservoir 1602 moves fluid through the active valve to the cuff 1604). In some examples, in response to a user initiating a deflation cycle using the external device 1601, the external device 1601 can send a wireless signal to the electronic pump assembly 1606 to initiate a deflation cycle to transfer fluid from the cuff 1604 to the fluid reservoir 1602.

[0075] 17 illustrates a flowchart 1700 depicting example operations for operating an implantable device. The operations of flowchart 1700 of FIG. 17 may be performed by any of the devices discussed herein.

[0076] Operation 1702 includes detecting a signal to operate a pump of an electronic pump assembly including a piezoelectric pump with a passive valve. Operation 1704 includes transferring fluid from a fluid reservoir with the pump. Operation 1706 includes restricting the flow of fluid into the pump with a flow modifier.

[0077] Detailed embodiments have been discussed in this specification. However, it is understood that the disclosed embodiments of the present invention are merely examples that can be embodied in various forms. Therefore, the specific structural and functional details disclosed in this specification should not be interpreted as limiting, but only as a representative basis for teaching those skilled in the art how to vary these embodiments into virtually any suitable detailed structure. Furthermore, the terms and phrases used in this specification are not limiting, but are intended to provide an understandable description of the disclosure of the present invention.

[0078] 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 a third 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 connected, but not necessarily directly and mechanically.

[0079] In general, the above-described embodiments relate to bodily implants. In this specification, the term patient or user may be used for an individual who may benefit from the medical device or method disclosed in the present disclosure. For example, a patient may be an individual whose body is implanted with a medical device or method of operating the same disclosed by the present disclosure. For example, in some embodiments, a patient may be a human being.

[0080] While certain features of the implementations described above have been illustrated as described herein, many modifications, substitutions, variations, and equivalents will now occur to those of ordinary skill 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 embodiments. [Explanation of symbols]

[0081] 102 Fluid Reservoir 104 Expandable member 106 Electronic Pump Assembly 121 Passive valve 145 Flow Corrector

Claims

1. a pump configured to move fluid to or from a fluid reservoir of the device and including a passive valve; a controller configured to operate the pump; a flow modifier configured to restrict the flow of fluid into or within the pump; an electronic pump assembly including:

2. The electronic pump assembly of claim 1 , wherein the flow modifier includes a filter disposed in a fluid passage connected to the pump.

3. 3. The electronic pump assembly of claim 2, wherein the filter is a first filter connected to an inlet of the pump, and the electronic pump assembly includes a second filter connected to an outlet of the pump.

4. The electronic pump assembly of claim 2 , wherein the filter includes a tubular member defining a cavity, the filter including a filter component disposed within the cavity of the tubular member and defining a plurality of holes.

5. The electronic pump assembly of claim 4 , wherein the plurality of holes comprises linear holes.

6. The electronic pump assembly of claim 4 , wherein the plurality of holes comprises conical holes.

7. 5. The electronic pump assembly of claim 4, wherein the filter component includes a cylindrical portion having a first end portion and a second end portion, the first end portion including a flat surface and the second end portion including a conical portion.

8. An electronic pump assembly according to any preceding claim, wherein the flow modifier is defined by at least a portion of the passive valve.

9. An electronic pump assembly according to any preceding claim, wherein the pump includes a piezoelectric element, a diaphragm actuator, and a base plate defining an inlet port and an outlet port.

10. 10. The electronic pump assembly of claim 9, wherein the pump includes a first layer of material defining a first passive valve and a second layer of material defining a second passive valve, the first layer of material and the second layer of material being disposed between the diaphragm actuator and the base plate.

11. a fluid reservoir configured to hold a fluid; an expandable member; an electronic pump assembly configured to transfer the fluid between the fluid reservoir and the expandable member; 1. An implantable device comprising: The electronic pump assembly includes: a pump configured to move fluid to or from a fluid reservoir of the device, the pump including a first passive valve and a second passive valve; a controller configured to operate the pump; and a flow modifier configured to restrict the flow of fluid into or within the pump; 1. An implantable device comprising:

12. 12. The implantable device of claim 11, wherein the flow modifier includes a filter disposed in a fluid passage connected to the pump, the filter including a tubular member defining a cavity, the filter including a cylindrical member disposed within the cavity of the tubular member and defining a plurality of holes.

13. 13. The implantable device of claim 12, wherein the plurality of holes comprises circular holes, Y-shaped holes, hexagonal holes, honeycomb holes, or holes arranged in a spiral lattice.

14. 1. A method of controlling an implantable device, comprising: detecting a signal to operate a pump of an electronic pump assembly, the pump including a piezoelectric pump having a passive valve; pumping fluid from a fluid reservoir with the pump; restricting fluid flow into said pump with a flow modifier; The method includes:

15. The method of claim 14 , wherein the flow modifier is disposed in a fluid passageway between the fluid reservoir and the pump.

16. a pump configured to move fluid to or from a fluid reservoir of the device and including a passive valve; a controller configured to operate the pump; a flow modifier configured to restrict the flow of fluid into or within the pump; an electronic pump assembly including:

17. The electronic pump assembly of claim 16 , wherein the flow modifier includes a filter disposed in a fluid passage connected to the pump.

18. 18. The electronic pump assembly of claim 17, wherein the filter is a first filter connected to an inlet of the pump and the electronic pump assembly includes a second filter connected to an outlet of the pump.

19. 20. The electronic pump assembly of claim 17, wherein the filter includes a tubular member defining a cavity, the filter including a filter component disposed within the cavity of the tubular member and defining a plurality of holes.

20. The electronic pump assembly of claim 19 , wherein the plurality of holes comprises linear holes.

21. The electronic pump assembly of claim 19 , wherein the plurality of holes comprises conical holes.

22. 20. The electronic pump assembly of claim 19, wherein the filter component includes a cylindrical portion having a first end portion and a second end portion, the first end portion including a flat surface and the second end portion including a conical portion.

23. The electronic pump assembly of claim 16 , wherein the flow modifier is defined by at least a portion of the passive valve.

24. 17. The electronic pump assembly of claim 16, wherein the pump includes a piezoelectric element, a diaphragm actuator, and a base plate defining an inlet port and an outlet port.

25. 25. The electronic pump assembly of claim 24, wherein the pump includes a first layer of material defining a first passive valve and a second layer of material defining a second passive valve, the first layer of material and the second layer of material being disposed between the diaphragm actuator and the base plate.

26. a fluid reservoir configured to hold a fluid; an expandable member; an electronic pump assembly configured to transfer the fluid between the fluid reservoir and the expandable member, The electronic pump assembly includes: a pump configured to move fluid to or from a fluid reservoir of the device, the pump including a first passive valve and a second passive valve; a controller configured to operate the pump; and a flow modifier configured to restrict the flow of fluid into or within the pump.

27. 27. The implantable device of claim 26, wherein the flow modifier includes a filter disposed in a fluid passageway connected to the pump.

28. 28. The implantable device of claim 27, wherein the filter includes a tubular member defining a cavity, the filter including a cylindrical member disposed within the cavity of the tubular member and defining a plurality of holes.

29. 30. The implantable device of claim 28, wherein the plurality of holes comprises circular holes, Y-shaped holes, hexagonal holes, honeycomb holes, or holes arranged in a spiral lattice.

30. 27. The implantable device of claim 26, wherein the flow modifier is defined by at least a portion of the passive valve.

31. 27. The implantable device of claim 26, wherein the pump includes a piezoelectric element, a diaphragm actuator, and a base plate defining an inlet port and an outlet port.

32. 32. The implantable device of claim 31 , wherein the pump includes a first layer of material defining the first passive valve and a second layer of material defining the second passive valve, the first layer of material and the second layer of material being disposed between the diaphragm actuator and the base plate.

33. 33. The implantable device of claim 32, wherein at least one of the first layer of material or the second layer of material is harder than a material of the diaphragm actuator.

34. 1. A method of controlling an implantable device, comprising: detecting a signal to operate a pump of an electronic pump assembly, the pump including a piezoelectric pump having a passive valve; pumping fluid from a fluid reservoir with the pump; restricting fluid flow into said pump with a flow modifier; The method includes:

35. 35. The method of claim 34, wherein the flow modifier is disposed in a fluid passage between the fluid reservoir and the pump.

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