EP-4739254-A1 - MICRO-FLUIDIC DEVICE COMBINING FUNCTIONS OF A PUMP AND A VALVE

Abstract

An implantable fluid operated device may include a fluid reservoir configured to hold fluid, an inflatable member, and an electronic fluid control system to transfer fluid between the fluid reservoir and the inflatable member. The fluid control system includes at least one combination pump and valve device including a piezoelectric actuator.

Inventors

• CAREY, MARTIN
• SMITH, NOEL
• MARCOS LARANGEIRA, Eduardo
• SINNOTT, Thomas
• PERCY, RICHARD
• NOLAN, Daragh

Assignees

• Boston Scientific Scimed, Inc.

Dates

Publication Date

20260513

Application Date

20240702

Claims (20)

1. 1. An implantable fluid operated inflatable device, comprising: a fluid reservoir; an inflatable member; and a fluid control system configured to control fluid flow between the fluid reservoir and the inflatable member, the fluid control system including: fluidic architecture defining one or more fluid passageways within in a housing; and at least one combined pump and valve device positioned in the one or more fluid passageways, the at least one combined pump and valve device, the at least one combined pump and valve device including: a base plate; a passive foil layer positioned in a recessed portion of the base plate; an actuator plate coupled to the base plate so as to define a chamber with the recessed portion of the base plate; a first disc selectively engaging a first opening formed in a first valve pocket in the base plate or a first opening in the passive foil layer in response to a voltage applied to the actuator plate; and a second disc selectively engaging a second opening formed in a second valve pocket in the base plate or a second opening in the passive foil layer in response to a voltage applied to the actuator plate.
2. 2. The implantable fluid operated inflatable device of claim 1, wherein the first opening in the base plate has a substantially circular shape, the first opening in the passive foil layer has a substantially elliptical shape, the second opening in the base plate has a substantially elliptical shape, and the second opening in the passive foil layer has a substantially circular shape.
3. 3. The implantable fluid operated inflatable device of claim 1 or claim 2, wherein, in response to a first voltage applied to the actuator plate positions the first disc is positioned against the first opening in the passive foil layer, and the second disc is positioned against the second opening in the passive foil layer.
4. 4. The implantable fluid operated inflatable device of claim 3, wherein, in response to a second voltage applied to the actuator plate, the first disc is positioned against the first opening in the base plate, and the second disc is positioned against the second opening in the base plate.
5. 5. The implantable fluid operated inflatable device of claim 4, wherein, in response to the first voltage applied to the actuator plate, the first disc partially blocks the first opening in the passive foil layer; and the second disc fully blocks the second opening in the passive foil layer.
6. 6. The implantable fluid operated inflatable device of claim 5, wherein, in response to the first voltage applied to the actuator plate, fluid flows into the chamber through the first opening formed in the base plate and through open end portions of the first opening in the passive foil layer; and fluid is retained in the chamber by the second disc positioned against the second opening in the passive foil layer to fill the chamber with fluid.
7. 7. The implantable fluid operated inflatable device of any of claims 4 to 6, wherein, in response to the second voltage applied to the actuator plate, the first disc fully blocks the first opening in the base plate; and the second disc partially blocks the second opening in the base plate.
8. 8. The implantable fluid operated inflatable device of claim 7, wherein, in response to the second voltage applied to the actuator plate, fluid flows out of the chamber through open end portions of the second opening formed in the passive foil layer and through the second opening in the base plate; and backflow of fluid from the chamber is restricted by the first disc positioned against the first opening in the base plate.
9. 9. The implantable fluid operated inflatable device of any preceding claim, wherein the base plate includes: a base portion; and a rim portion extending along a peripheral portion of the base portion, wherein the recessed portion of the base plate is formed within an area defined by the base portion and the rim portion, and wherein the first valve pocket and the second valve pocket are formed in the base portion of the base plate.
10. 10. The implantable fluid operated inflatable device of any preceding claim, wherein the at least one combined pump and valve device includes a seal provided on an interior facing side of the actuator plate, wherein the seal extends down into recessed portion of the base plate to seal the chamber.
11. 11. The implantable fluid operated inflatable device of any preceding claim, wherein the first disc is a floating disc positioned within the first valve pocket formed in the base plate, such that the first disc is movable in the first valve pocket, between the first opening in the base plate and the first opening in the passive foil layer, in response to an application of voltage to the actuator plate; and the second disc is a floating disc positioned within the second valve pocket formed in the base plate, such that the second disc is movable in the second valve pocket, between the second opening in the base plate and the second opening in the passive foil layer, in response to an application of voltage to the actuator plate.
12. 12. The implantable fluid operated inflatable device of any preceding claim, wherein the actuator plate is operable in response to an application of voltage thereto by an electronic control system of the fluid control system.
13. 13. The implantable fluid operated inflatable device of any preceding claim, wherein the actuator plate comprises a piezoelectric actuator that is operable in response to an application of voltage thereto by an electronic control system of the fluid control system.
14. 14. The implantable fluid operated inflatable device of any preceding claim, wherein the first valve pocket, the first opening in the base plate, the first disc, and the first opening in the passive foil layer define a first pocket valve controlling a flow of fluid from a first fluid passageway into the chamber; and the second valve pocket, the second opening in the base plate, the second disc, and the second opening in the passive foil layer define a second pocket valve controlling a flow of fluid out of the chamber to at least one second fluid passageway.
15. 15. The implantable fluid operated inflatable device of claim 14, wherein the first fluid passageway provides for fluid communication between the fluid reservoir and the fluid control system, and the at least one second fluid passageway provides for fluid communication between inflatable member and the fluid control system.
16. 16. An implantable fluid operated inflatable device, comprising: a fluid reservoir; an inflatable member; and a fluid control system configured to control fluid flow between the fluid reservoir and the inflatable member, the fluid control system including: at least one combined pump and valve device positioned in one or more fluid passageways defined within a housing, the at least one combined pump and valve device including: a base plate; a passive foil layer positioned in a recessed portion of the base plate; an actuator plate coupled to the base plate so as to define a chamber with the recessed portion of the base plate; a first disc selectively engaging a first opening formed in a first valve pocket in the base plate or a first opening in the passive foil layer in response to a voltage applied to the actuator plate; and a second disc selectively engaging a second opening formed in a second valve pocket in the base plate or a second opening in the passive foil layer in response to a voltage applied to the actuator plate.
17. 17. The implantable fluid operated inflatable device of claim 16, wherein the first opening in the base plate has a substantially circular shape, the first opening in the passive foil layer has a substantially elliptical shape, the second opening in the base plate has a substantially elliptical shape, and the second opening in the passive foil layer has a substantially circular shape.
18. 18. The implantable fluid operated inflatable device of claim 16, wherein in response to a first voltage applied to the actuator plate, the first disc is positioned against the first opening in the passive foil layer, and the second disc is positioned against the second opening in the passive foil layer, and in response to a second voltage applied to the actuator plate, the first disc is positioned against the first opening in the base plate, and the second disc is positioned against the second opening in the base plate.
19. 19. The implantable fluid operated inflatable device of claim 18, wherein, in response to the first voltage applied to the actuator plate, the first disc partially blocks the first opening in the passive foil layer; and the second disc fully blocks the second opening in the passive foil layer.
20. 20. The implantable fluid operated inflatable device of claim 19, wherein, in response to the first voltage applied to the actuator plate, fluid flows into the chamber through the first opening formed in the base plate and through open end portions of the first opening in the passive foil layer; and fluid is retained in the chamber by the second disc positioned against the second opening in the passive foil layer to fill the chamber with fluid.

Description

MICRO-FLUIDIC DEVICE COMBINING FUNCTIONS OF A PUMP AND A VALVE CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of, and claims priority to, U.S. Nonprovisional Patent Application No. 18/760,646, filed on July 1, 2024, entitled “MICRO-FLUIDIC DEVICE COMBINING FUNCTIONS OF A PUMP AND A VALVE”, which claims priority to U.S. Provisional Patent Application No. 63/512.141, filed on July 6, 2023, entitled “MICRO-FLUIDIC DEVICE COMBINING FUNCTIONS OF A PUMP AND A VALVE”, the disclosures of which are incorporated by reference herein in their entirety. [0002] This application also claims priority to U.S. Provisional Patent Application No. 63/512,141, filed on July 6, 2023, the disclosure of which is incorporated by reference herein in its entirety. TECHNICAL FIELD [0003] This disclosure relates generally to bodily implants, and more specifically to bodily implants including a fluid control system having one or more pumps and/or valves including a piezoelectric actuator. BACKGROUND [0004] Active implantable fluid operated inflatable devices can include one or more pumps that regulate a flow of fluid between different portions of the implantable device. One or more valves can be positioned within fluid passageways of the device to direct and control the flow of fluid to achieve inflation, deflation, pressurization, depressurization, activation, deactivation and the like of different fluid filled implant components of the device. In some implantable fluid operated devices, an implantable pumping device may be manually operated by the user to provide for the transfer of fluid between a reservoir and the fluid filled implant components of the device. Manipulation of the manually operated implantable pumping device may be challenging for some patients. Further, such manual operation of the pumping device may make it may be difficult to achieve consistent inflation, deflation, pressurization, depressurization, activation, deactivation and the like of the fluid filled implant components. Inconsistent inflation, deflation, pressurization, depressurization, activation and/or deactivation of the fluid filled implant device(s) may adversely affect patient comfort, efficacy of the device, and the overall patient experience. Some implantable fluid operated devices may include an electronic control system including an electronically controlled manifold providing for the transfer of fluid within the implantable fluid operated device. The use of the electronic control system may provide for more accurate actuation and control of the flow of fluid between components of the inflatable device, thus improving performance and efficacy of the device, as well as patient comfort and safety. In some situations, a size and/or a configuration of the electronic control system, driven at least in part by the number and/or positioning pumps and/or valves within a manifold of the electronic control system, may pose a challenge to some patients. SUMMARY [0005] In a general aspect, an implantable fluid operated inflatable device includes a fluid reservoir; an inflatable member; and a fluid control system configured to control fluid flow betw een the fluid reservoir and the inflatable member. The fluid control system may include fluidic architecture defining one or more fluid passageways within in a housing; and at least one combined pump and valve device positioned in the one or more fluid passageways, the at least one combined pump and valve device. The at least one combined pump and valve device may include a base plate; a passive foil layer positioned in a recessed portion of the base plate; an actuator plate coupled to the base plate so as to define a chamber with the recessed portion of the base plate; a first disc selectively engaging a first opening formed in a first valve pocket in the base plate or a first opening in the passive foil layer in response to a voltage applied to the actuator plate; and a second disc selectively engaging a second opening formed in a second valve pocket in the base plate or a second opening in the passive foil layer in response to a voltage applied to the actuator plate. [0006] In some implementations, the first opening in the base plate has a substantially circular shape, the first opening in the passive foil layer has a substantially elliptical shape, the second opening in the base plate has a substantially elliptical shape, and the second opening in the passive foil layer has a substantially circular shape. [0007] In some implementations, in response to a first voltage applied to the actuator plate, the first disc is positioned against the first opening in the passive foil layer, and the second disc is positioned against the second opening in the passive foil layer. In response to a second voltage applied to the actuator plate, the first disc is positioned against the first opening in the base plate, and the second disc is positioned against the second opening in the base pl