EP-4739255-A1 - PIEZOELECTRIC NON-RETURN VALVE

Abstract

An implantable fluid operated device includes a fluid control system to transfer fluid between a fluid reservoir and an inflatable member. The fluid control system includes at least one fluid control device including at least one pump and at least one valve, or at least one combination pump and valve device. The at least one fluid control device includes an auxiliary fluid control device that maintains a closed state of the valve in response to a fluctuation in pressure, or a pressure spike that would otherwise cause an unintentional opening of the fluid control device, and unintentional flow of fluid through the fluid control device.

Inventors

• NOLAN, Daragh
• PERCY, RICHARD
• SINNOTT, Thomas
• MARCOS LARANGEIRA, Eduardo

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 control system configured to control fluid flow between a fluid reservoir and an inflatable member, the fluid control system including: at least one fluid passageway defined within a housing; and a fluidic component positioned in the at least one fluid passageway and configured to provide for a flow of fluid in a first flow direction, and to restrict a flow of fluid in a second flow direction, the fluidic component including: a fluid chamber defined between a base plate and a deformable diaphragm; and an auxiliary fluid control device provided at one of an inlet into the fluid chamber or an outlet of the fluid chamber, wherein in an open state of the fluidic component, the auxiliary fluid control device is in an open state such that inlet, the fluid chamber, and the outlet provide for fluid flow through the fluidic component in the first flow direction, and in a closed state of the fluidic component, the auxiliary fluid control device is configured to close one of the inlet or the outlet of the fluid chamber in response to a force applied in the second flow direction, to maintain the closed state of the fluidic component.
2. 2. The implantable fluid operated inflatable device of claim 1, wherein the auxiliary fluid control device comprises a spring check valve positioned in the outlet, wherein in the open state of the fluidic component, the spring check valve is opened in response to a force of fluid, flowing from the fluid chamber toward the outlet, exerted on a disc portion of the spring check valve, and in the closed state of the fluidic component, the spring check valve is closed against a foil positioned between the spring check valve and the outlet in response to a force of fluid, flowing from the outlet toward the fluid chamber, exerted on the disc portion of the spring check valve.
3. 3. The implantable fluid operated inflatable device of claim 2, wherein a dimension of the disc portion of the spring check valve is greater than a corresponding dimension of an opening formed in the foil, such that in the closed state the force exerted on the disc portion maintains the spring check valve in the closed state.
4. 4. The implantable fluid operated inflatable device of claim 1, wherein the auxiliary fluid control device comprises a seal positioned on the base plate, at a position corresponding to the inlet, the seal including: a body portion; a first flange portion at a first end portion of the body portion; and a second flange portion at a second end portion of the body portion, wherein the first flange portion is coupled to the base plate, with an opening extending through the body portion aligned with the inlet, and the second flange portion is positioned in the fluid chamber; in the open state of the fluidic component, fluid flows from the inlet, through a space in the fluid chamber between the second flange portion and the diaphragm, and out of the fluidic component through the outlet; and in the closed state of the fluidic component, the second flange portion is positioned against the diaphragm and forms a seal with the diaphragm, and the second flange portion is configured to deform so as to maintain the seal with the diaphragm in response to the force of fluid from the outlet exerted on the diaphragm and a corresponding deformation of the diaphragm.
5. 5. The implantable fluid operated inflatable device of claim 1, wherein the auxiliary fluid control device comprises an umbrella valve positioned in inlet, the umbrella valve including: a body portion positioned in the inlet; a first flange portion at a first end portion of the body portion; at least one opening formed in the first flange portion, aligned with the inlet; and a second flange portion at a second end portion of the body portion, positioned in the fluid chamber, wherein in the open state of the fluidic component, the umbrella valve is in a first position in the inlet, in which the second flange portion is spaced apart from a first side portion of the base plate to provide for fluid communication between the inlet and the fluid chamber, and the first flange portion is positioned at a second side portion of the base plate, with the at least one opening in the first flange portion aligned with the inlet, such that fluid flows through the at least one opening, through the inlet into the fluid chamber and out of the fluidic component through the outlet; and in the closed state of the fluidic component, the umbrella valve is in a second position in the inlet, in which the second flange portion is positioned on the first side portion of the base plate, extending across the inlet in response to a force of fluid from the outlet so as to maintain a closed state of the inlet and the closed state of the fluidic component.
6. 6. The implantable fluid operated inflatable device of claim 1, wherein the auxiliary fluid control device comprises a flap seal valve positioned in the inlet, the flap seal valve including: a body portion; a base portion at a first end portion of the body portion, the base portion being fixed in the inlet, with an opening extending through the base portion to provide for fluid communication with the fluid chamber; and a flap portion at a second end portion of the body portion, wherein in the open state of the fluidic component, fluid flows through the opening in the base portion and into fluid chamber, and out of the fluidic component through the outlet, and in the closed state of the fluidic component, the flap portion is configured to deform so as to close the opening in the base portion in response to a force of fluid from the outlet toward the fluid chamber.
7. 7. The implantable fluid operated inflatable device of any preceding claim, wherein the fluidic component is a piezoelectric valve device, comprising: a piezoelectric element coupled to the deformable diaphragm; at least one electrode coupled to the piezoelectric element, wherein the deformable diaphragm is configured to deform in response to voltage applied to the piezoelectric element to move between the open state and the closed state of the fluidic component; a first fluid passageway and a first opening formed in the base plate, wherein the first fluid passageway and the first opening define the inlet into the fluid chamber; and a second fluid passageway and a second opening formed in the base plate, wherein the second fluid passageway and the second opening define the outlet of the fluid chamber.
8. 8. The implantable fluid operated inflatable device of any preceding claim, wherein the first flow direction provides for the flow of fluid from the fluid reservoir to the inflatable member, and the second flow direction provides for the flow of fluid from the inflatable member to the fluid reservoir.
9. 9. The implantable fluid operated inflatable device of any preceding claim, wherein the inlet is defined by a first opening in the base plate providing for fluid communication between a first fluid passageway of the fluidic component and the fluid chamber; and the outlet is defined by a second opening in the base plate providing for fluid communication between the fluid chamber and a second fluid passageway of the fluidic component.
10. 10. The implantable fluid operated inflatable device of any preceding claim, wherein the fluidic component is one of a valve device, a pump device, or a combined pump and valve device.
11. 11. A fluid control system for an implantable fluid operated inflatable device, comprising: a housing; at least one fluid passageway defined within the housing; and a valve device positioned in the at least one fluid passageway, the valve device including: a base plate; a diaphragm coupled to the base plate; a fluid chamber defined between the base plate and the diaphragm; a first opening formed in the base plate, the first opening connecting the fluid chamber to a first fluid passageway; a second opening formed in the base plate, the second opening connecting the fluid chamber to a second fluid passageway; and a fluid control device provided at the one of the first opening or the second opening, wherein in an open state of the valve device, the first fluid passageway, the fluid chamber, and the second fluid passageway guides fluid through the valve device in a first flow direction, and in a closed state of the valve device, the fluid control device is configured to close the one of the first fluid passageway or the second fluid passageway in response to a force applied in a second flow direction, opposite the first flow direction, to maintain the closed state of the valve device.
12. 12. The fluid control system of claim 11. wherein the fluid control device comprises a spring check valve positioned in the second fluid passageway, wherein in the open state of the valve device, the spring check valve is opened in response to a force of fluid flowing from the fluid chamber to the second fluid passageway, and in the closed state of the valve device, the spring check valve is closed against the diaphragm in response to a force of fluid flowing from the second fluid passageway toward the fluid chamber, wherein a dimension of a disc portion of the spring check valve is greater than a corresponding dimension of the second opening in the base plate, such that in the closed state the force exerted on the disc portion by fluid flowing from the second fluid passageway toward the fluid chamber maintains the spring check valve in a closed state against the second opening in the base plate.
13. 13. The fluid control system of claim 11, wherein the fluid control device comprises a seal positioned on the base plate, at a position corresponding to the first opening in the base plate, wherein in the open state of the valve device, fluid flows through the valve device from the first fluid passageway, through a space in the fluid chamber between the seal and the diaphragm, and out of the valve device through the second fluid passageway, and in the closed state of the valve device, a deformable portion of the seal deforms in response to a force of fluid flowing from the second fluid passageway toward the fluid chamber to block a flow of fluid from the fluid chamber into the first fluid passageway.
14. 14. The fluid control system of claim 13, wherein the deformable portion of the seal includes one of: a flange portion of the seal that deforms in response to the force, to maintain a seal with the diaphragm, or a flap portion of the seal that deforms in response to the force, to close an opening in a base portion of the seal positioned in the first fluid passageway.
15. 15. The fluid control system of claim 11. wherein the fluid control device comprises an umbrella valve positioned in the first fluid passageway formed in the base plate, wherein In the open state of the valve device, the umbrella valve is in a first position in the first fluid passageway in response to a force of fluid flowing from the first fluid passageway toward the fluid chamber, and fluid flows through at least one opening in a first flange portion of the umbrella valve and the first fluid passageway, through the fluid chamber, and out of the valve device through the second fluid passageway, and in the closed state of the valve device, the umbrella valve is in a second position in the first fluid passageway in which a second flange portion of the umbrella valve extends across the first opening to close the first opening in the base plate and block a flow of fluid between the fluid chamber and the first fluid passageway in response to a force of fluid flowing from the second fluid passageway toward the fluid chamber.
16. 16. A fluid control system for an implantable fluid operated inflatable device, comprising: a housing; at least one fluid passageway defined within the housing; and a valve device positioned in the at least one fluid passageway, the valve device including: a base plate; a diaphragm coupled to the base plate; a fluid chamber defined between the base plate and the diaphragm; a first opening formed in the base plate, the first opening connecting the fluid chamber to a first fluid passageway; a second opening formed in the base plate, the second opening connecting the fluid chamber to a second fluid passageway; and a fluid control device provided at the one of the first opening or the second opening, wherein in an open state of the valve device, the first fluid passageway, the fluid chamber, and the second fluid passageway guides fluid through the valve device in a first fluid flow direction, and in a closed state of the valve device, the fluid control device is configured to close the one of the first fluid passageway or the second fluid passageway in response to a force applied in a second fluid flow direction, opposite the first fluid flow direction, to maintain the closed state of the valve device.
17. 17. The fluid control system of claim 16. wherein the fluid control device comprises a spring check valve positioned in the second fluid passageway, wherein in the open state of the valve device, the spring check valve is opened in response to a force of fluid flowing from the fluid chamber to the second fluid passageway, and in the closed state of the valve device, the spring check valve is closed against the diaphragm in response to a force of fluid flowing from the second fluid passageway toward the fluid chamber.
18. 18. The fluid control system of claim 17, wherein the fluid control device includes: a spring plate positioned on the base plate of the valve device, with the spring check valve formed in the spring plate, at a position corresponding to the second opening in the base plate and an opening formed at a position corresponding to the first opening in the base plate; and a foil plate positioned between the base plate and the spring plate, including a first opening at a position corresponding to the first opening in the base plate and the opening in the spring plate and a second opening corresponding to the spring check valve and the second opening in the base plate.
19. 19. The fluid control system of claim 17, wherein a dimension of a disc portion of the spring check valve is greater than a corresponding dimension of the second opening in the base plate, such that in the closed state the force exerted on the disc portion by fluid flowing from the second fluid passageway toward the fluid chamber maintains the spring check valve in a closed state against the second opening in the base plate.
20. 20. The fluid control system of claim 16. wherein the fluid control device comprises a seal positioned on the base plate, at a position corresponding to the first opening in the base plate, wherein in the open state of the valve device, fluid flows through the valve device from the first fluid passageway, through a space in the fluid chamber between the seal and the diaphragm, and out of the valve device through the second fluid passageway, and in the closed state of the valve device, at least a portion of the seal deforms to maintain a seal against the diaphragm in response to a force of fluid flowing from the second fluid passageway toward the fluid chamber.

Description

PIEZOELECTRIC NON RETURN VALVE CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of, and claims priority to, U.S. Nonprovisional Patent Application No. 18/760,693, filed on July 1, 2024, entitled “PIEZOELECTRIC NON-RETURN VALVE”, which claims priority' to U.S. Provisional Patent Application No. 63/512,150, filed on July 6, 2023, entitled “PIEZOELECTRIC NON-RETURN VALVE”, the disclosures of which are incorporated by reference herein in their entirety'. [0002] This application also claims priority7 to U.S. Provisional Patent Application No. 63/512,150, 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 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. In some situations, manual operation of the pumping device may make it 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 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. Consistent inflation, deflation, pressurization, depressurization, activation, deactivation and the like of the fluid filled implant components may rely on accurate flow control through the pumps and/or valves w ithin a manifold of the electronic control system. Fluctuations in pressure may be experienced within the manifold due to, for example, movement of the user, falls, and the like. A system and method for maintaining set positions of various components of the pumps and/or valves in the manifold in the event of fluctuations in pressure, pressure spikes and the like, may provide for consistent flow of fluid through the manifold, and for consistent, accurate control of the inflation, deflation, pressurization, depressurization, activation, deactivation and the like of the fluid filled components of the implantable fluid operated inflatable device. SUMMARY [0005] In some aspects, the techniques described herein relate to an implantable fluid operated inflatable device, including a fluid control system configured to control fluid flow between a fluid reservoir and an inflatable member, the fluid control system including at least one fluid passageway defined within a housing; and a fluidic component positioned in the at least one fluid passageway and configured to provide for a flow of fluid in a first flow direction, and to restrict a flow of fluid in a second flow direction, the fluidic component including a fluid chamber defined betw een a base plate and a deformable diaphragm; and an auxiliary fluid control device provided at one of an inlet into the fluid chamber or an outlet of the fluid chamber, wherein in an open state of the fluidic component, the auxiliary fluid control device is in an open state such that inlet, the fluid chamber, and the outlet provide for fluid flow through the fluidic component in the first flow direction, and in a closed state of the fluidic component, the auxiliary fluid control device is configured to close one of the inlet or the outlet of the fluid chamber in response to a force applied in the second flow direction, to maintain the closed state of the fluidic component. [0006] In some implementations, the auxiliary fluid control device includes a spring check valve positioned in the outlet, wherein in the open state of the fluidic component, the spring check valve is opened in response to a force of fluid, flowing from the fluid chamber toward the outlet, exerted on a disc portion of the