Piezoelectric check valve closure

Abstract

An implantable fluid operated device includes a fluid control system to transfer fluid between a fluid reservoir and a fillable member. The fluid control system includes at least one fluid control device including at least one valve and at least one pump, or at least one combined pump and valve device. A seal is disposed in the at least one fluid control device. In a first mode, the seal provides a seal between the fluid passage and a fluid chamber of the fluid control device to close the fluid control device. In a second mode, the seal is disengaged to open the fluid control device and allow fluid to flow between the fluid passage and the fluid chamber. The seal retention device maintains the position of the seal when the fluid control device is open and fluid is flowing through the fluid control device.

Description

[0001] Cross-references to related applications

[0002] This application is a continuation-to-priority of U.S. Non-Provisional Patent Application No. 18 / 765,820, filed July 8, 2024, entitled “PIEZOELECTRIC NON-RETURN VALVESHUT-OFF”, which claims priority to U.S. Provisional Patent Application No. 63 / 512,931, filed July 11, 2023, entitled “PIEZOELECTRIC NON-RETURN VALVESHUT-OFF”, the disclosure of which is incorporated herein by reference in its entirety.

[0003] This application also claims priority to U.S. Provisional Patent Application No. 63 / 512,931, filed July 11, 2023, the disclosure of which is incorporated herein by reference in its entirety. Background Technology

[0004] This disclosure relates generally to in vivo implants, and more particularly to in vivo implants including a fluid control system having one or more pumps and / or valves including piezoelectric actuators. Background Technology

[0005] Active implantable fluid-operated inflatable devices may include one or more pumps that regulate fluid flow between different parts of the implantable device. One or more valves may be positioned within the fluid channels of the device to guide and control fluid flow, thereby enabling inflation, deflation, pressurization, depressurization, activation, and deactivation of the different fluid-filled components of the device. In some implantable fluid-operated devices, the implantable pumping device may be manually operated by the user to provide fluid transfer between the device's reservoir and the fluid-filled implanted component. In some cases, manual operation of the pumping device may make it difficult to achieve consistent inflation, deflation, pressurization, depressurization, activation, and deactivation of the fluid-filled implanted component. Inconsistent inflation, deflation, pressurization, depressurization, activation, and / or deactivation of the fluid-filled implanted device may adversely affect patient comfort, device effectiveness, and the overall patient experience. Some implantable fluid-operated devices include an electronic control system that includes an electronically controlled manifold providing fluid transfer within the implantable fluid-operated device. The use of an electronic control system can provide more precise actuation and control of fluid flow between components of an inflatable device, thereby improving the device's performance and effectiveness, as well as patient comfort and safety. Consistent filling, venting, pressurizing, depressurizing, activating, and deactivating of fluid-filled implantable components can rely on precise flow control via pumps and / or valves within the manifold of the electronic control system. Setting and maintaining the position of various components of the pumps and / or valves in the manifold provides consistent flow of fluid through the manifold and provides consistent and precise control over the filling, venting, pressurizing, depressurizing, activating, and deactivating of fluid-filled components of an implantable fluid-operated inflatable device. Summary of the Invention

[0006] In general, an implantable fluid-operable inflatable device includes: a housing; at least one fluid channel located within the housing; and a fluid control device positioned in the at least one fluid channel, the fluid control device including: a substrate; a diaphragm coupled to the substrate; a fluid chamber defined between the substrate and the diaphragm; an opening formed in the substrate connecting the fluid chamber to the fluid channel of the fluid control device; a seal disposed at the opening and configured to form a seal between the fluid channel and the fluid chamber in a closed state of the fluid control device; and a seal retention mechanism engaging with the seal and configured to retain the position of the seal in an open state of the fluid control device.

[0007] In some embodiments, the seal includes an O-ring positioned in a recess surrounding an opening formed in a substrate; and the seal retaining mechanism includes a textured layer formed on the surface of the recess; and a bonding layer located between the textured layer and the O-ring, the bonding layer coupling the O-ring to the recess via the textured layer.

[0008] In some embodiments, the seal includes an elastomeric O-ring received in a groove surrounding an opening formed in a substrate; and the seal retention mechanism includes an undercut portion formed at an opening leading to the groove, wherein the size of the opening is smaller than the corresponding size of the elastomeric O-ring, such that the elastomeric O-ring is retained in the groove by the undercut portion.

[0009] In some embodiments, the seal is an elastomeric O-ring, and wherein the seal retaining mechanism includes a groove surrounding an opening formed in a substrate, in which the elastomeric O-ring is received, wherein the inner circumferential portion of the groove is larger than the corresponding size of the O-ring, such that the O-ring is retained in the groove by a compressive force applied by the O-ring to the inner circumferential portion of the groove; or the outer circumferential portion of the groove is smaller than the corresponding size of the O-ring, such that the O-ring is retained in the groove by a tensile force applied by the O-ring to the outer circumferential portion of the groove.

[0010] In some embodiments, a seal is inserted and molded into a substrate. The seal includes: a body portion; a flange portion located at a first end portion of the body portion; a sealing portion located at a second end portion of the body portion; and an opening formed in the body portion. The seal retaining mechanism includes: an undercut portion formed in the body portion of the substrate and configured to engage the flange portion of the seal; and molding material received through the opening in the body portion of the seal and integrally formed between the body portion and the central opening of the substrate.

[0011] In some embodiments, the seal includes: a body portion; a flange portion located at a first end portion of the body portion; a sealing portion located at a second end portion of the body portion extending through a corresponding opening in the substrate; and an opening extending through the body portion from the first end portion to the second end portion of the body portion, and the seal holding mechanism includes: an undercut portion formed in the body portion of the substrate and configured to engage an upper portion of the flange portion of the seal; and a support plate coupled to a bottom portion of the substrate and configured to engage a bottom portion of the flange portion of the seal, such that the flange portion of the seal is held between the substrate and the support plate.

[0012] In some embodiments, the seal includes: a body portion; a flange portion located at a first end portion of the body portion; a sealing portion located at a second end portion of the body portion; and an opening extending through the body portion from the first end portion to the second end portion. The seal holding mechanism includes: a recessed portion formed in an upper portion of a substrate and configured to receive a lower portion of the flange portion of the seal; and a support plate coupled to the upper portion of the substrate and configured to engage the upper portion of the flange portion of the seal such that the flange portion of the seal is held between the support plate and the substrate, wherein the sealing portion of the seal extends through the opening in the support plate.

[0013] In some embodiments, the seal includes: a body portion; a first flange portion located at a first end portion of the body portion; a second flange portion located at a second end portion of the body portion, the second flange portion defining a sealing portion of the seal; and an opening extending through the first flange portion, the body portion, and the second flange portion; and the seal retaining mechanism includes: an undercut portion of the body portion of the substrate positioned to abut against an outer peripheral portion of the body portion of the seal and engaging the first flange portion and the second flange portion.

[0014] In some embodiments, the seal includes: a first sealing portion fixed to a stepped portion of a substrate extending from a body portion of the substrate into at least one fluid channel; and a second sealing portion fixed to a diaphragm, wherein, in a closed state relative to the substrate, the second sealing portion is positioned against the first sealing portion of the seal to block an opening formed in the first sealing portion and close at least one fluid channel; and in an open state relative to the substrate, the second sealing portion of the seal is spaced apart from the first sealing portion, thereby opening the opening formed in the first sealing portion and opening at least one fluid channel.

[0015] In some implementations, the fluid control device is one of a valve device, a pump device, or a combination of a pump and a valve device.

[0016] In another general aspect, an implantable fluid-operated inflatable device includes: a fluid control system configured to control the flow of fluid between a fluid reservoir and an inflatable member, the fluid control system including: at least one fluid channel defined within a housing; and at least one fluid-type component positioned within the at least one fluid channel and configured to control the flow of fluid through the at least one fluid channel, the at least one fluid-type component including: a fluid chamber; a seal positioned between the at least one fluid channel and the fluid chamber and configured to seal the interface between the at least one fluid channel and the fluid chamber in a closed position of the at least one fluid-type component; and a seal retention mechanism configured to retain the position of the seal in an open position of the at least one fluid-type component.

[0017] In some embodiments, the seal includes an O-ring positioned in a recess in an opening in a substrate surrounding at least one fluid component; and the seal retention mechanism includes a textured layer formed on the surface of the recess; and a bonding layer located between the textured layer and the O-ring, the bonding layer coupling the O-ring in the recess via the textured layer.

[0018] In some embodiments, a seal is inserted into a substrate of at least one fluid component. The seal includes: a body portion; a flange portion located at a first end portion of the body portion; a sealing portion located at a second end portion of the body portion; and an opening formed in the body portion. The seal retaining mechanism includes: an undercut portion formed in the body portion of the substrate and configured to engage the flange portion of the seal; and molding material received through the opening in the body portion of the seal and integrally formed between the body portion and the central opening of the substrate.

[0019] In some embodiments, the seal includes: a body portion; a flange portion located at a first end portion of the body portion; a sealing portion located at a second end portion of the body portion; and an opening extending through the body portion from the first end portion to the second end portion of the body portion, and the seal retention mechanism includes: an undercut portion formed in the body portion of the substrate of at least one fluid component and configured to engage an upper portion of the flange portion of the seal; and a support plate coupled to a bottom portion of the substrate and configured to engage a bottom portion of the flange portion of the seal, such that the flange portion of the seal is retained between the substrate and the support plate.

[0020] In some embodiments, the seal includes: a body portion; a first flange portion located at a first end portion of the body portion; a second flange portion located at a second end portion of the body portion, the second flange portion defining a sealing portion of the seal; and an opening extending through the first flange portion, the body portion, and the second flange portion, and the seal retaining mechanism includes: an undercut portion of the substrate of at least one fluid component, wherein the undercut portion is positioned against an outer peripheral portion of the body portion of the seal and engages the first flange portion and the second flange portion of the seal to retain the seal in position relative to the substrate.

[0021] In another general aspect, an implantable fluid-operated inflatable device includes: a fluid control system configured to control the flow of fluid between a fluid reservoir and an inflatable member, the fluid control system including: at least one fluid channel located within a housing; and at least one fluid-type component positioned within the at least one fluid channel and configured to control the flow of fluid through the at least one fluid channel, the at least one fluid-type component including: a fluid chamber; a seal positioned between the at least one fluid channel and the fluid chamber and configured to seal the interface between the at least one fluid channel and the fluid chamber in a closed position of the at least one fluid-type component; and a seal retention mechanism configured to retain the position of the seal in an open position of the at least one fluid-type component.

[0022] In some embodiments, at least one fluid component includes a valve device comprising: a substrate; an opening formed in the substrate connecting a fluid chamber to at least one fluid channel; a diaphragm coupled to the substrate, wherein the fluid chamber is defined between the substrate and the diaphragm; and a piezoelectric element coupled to the diaphragm, wherein: in response to a first voltage applied to the piezoelectric element, the diaphragm is in a closed position relative to the substrate, wherein a seal seals the interface between at least one fluid channel and the fluid chamber; and in response to a second voltage applied to the piezoelectric element, the diaphragm is deformed relative to the substrate to an open position to open the interface between at least one fluid channel and the fluid chamber, and a seal retaining mechanism retains the seal relative to the substrate.

[0023] In some embodiments, the seal includes an O-ring positioned in a recess surrounding an opening formed in a substrate; and the seal retaining mechanism includes a textured layer formed on the surface of the recess; and a bonding layer located between the textured layer and the O-ring, the bonding layer coupling the O-ring in the recess via the textured layer.

[0024] In some embodiments, the seal includes an O-ring positioned in a groove surrounding an opening formed in a substrate; and the seal retaining mechanism includes an undercut portion formed at the opening leading to the groove, wherein the size of the opening is smaller than the corresponding size of the O-ring, such that the O-ring is retained in the groove by the undercut portion.

[0025] In some embodiments, the seal is an elastomeric O-ring, and the seal retention mechanism includes a groove surrounding an opening formed in a substrate, wherein the O-ring is received in the groove, wherein the inner circumferential portion of the groove is larger than the corresponding size of the O-ring, such that the O-ring is retained in the groove by a compressive force applied by the O-ring to the inner circumferential portion of the groove; or the outer circumferential portion of the groove is smaller than the corresponding size of the O-ring, such that the O-ring is retained in the groove by a tensile force applied by the O-ring to the outer circumferential portion of the groove.

[0026] In some embodiments, a seal is inserted and molded into a substrate. The seal includes: a body portion; a flange portion located at a first end portion of the body portion; a sealing portion located at a second end portion of the body portion; and an opening formed in the body portion. The seal retaining mechanism includes: an undercut portion formed in the body portion of the substrate and configured to engage the flange portion of the seal; and molding material received through the opening in the body portion of the seal and integrally formed between the body portion and the central opening of the substrate.

[0027] In some embodiments, the seal includes: a body portion; a flange portion located at a first end portion of the body portion; a sealing portion located at a second end portion of the body portion extending through a corresponding opening in the substrate; and an opening extending through the body portion from the first end portion to the second end portion of the body portion, and the seal holding mechanism includes: an undercut portion formed in the body portion of the substrate and configured to engage an upper portion of the flange portion of the seal; and a support plate coupled to a bottom portion of the substrate and configured to engage a bottom portion of the flange portion of the seal, such that the flange portion of the seal is held between the substrate and the support plate.

[0028] In some embodiments, the seal includes: a body portion; a flange portion located at a first end portion of the body portion; a sealing portion located at a second end portion of the body portion; and an opening extending through the body portion from the first end portion to the second end portion. The seal holding mechanism includes: a recessed portion formed in an upper portion of a substrate and configured to receive a lower portion of the flange portion of the seal; and a support plate coupled to the upper portion of the substrate and configured to engage the upper portion of the flange portion of the seal such that the flange portion of the seal is held between the support plate and the substrate, wherein the sealing portion of the seal extends through the opening in the support plate.

[0029] In some embodiments, the seal includes: a body portion; a first flange portion located at a first end portion of the body portion; a second flange portion located at a second end portion of the body portion, the second flange portion defining a sealing portion of the seal; and an opening extending through the first flange portion, the body portion, and the second flange portion, and the seal retaining mechanism includes: an undercut portion of the body portion of the substrate positioned to abut against an outer peripheral portion of the body portion of the seal and engaging the first flange portion and the second flange portion.

[0030] In some embodiments, the seal includes: a first sealing portion fixed to a stepped portion of a substrate extending from a body portion of the substrate into at least one fluid channel; and a second sealing portion fixed to a diaphragm, wherein, in a closed position relative to the substrate, the second sealing portion is positioned against the first sealing portion of the seal to block an opening formed in the first sealing portion and close at least one fluid channel; and in an open position relative to the substrate, the second sealing portion of the seal is spaced apart from the first sealing portion, thereby opening the opening formed in the first sealing portion and opening at least one fluid channel.

[0031] In another general aspect, a fluid control system for an implantable, fluid-operated, inflatable device includes: at least one fluid channel defined within a housing; and a fluid control device positioned within the at least one fluid channel, the fluid control device including: a substrate; a diaphragm coupled to the substrate; a fluid chamber defined between the substrate and the diaphragm; an opening formed in the substrate connecting the fluid chamber to the fluid channel of the fluid control device; a seal disposed at the opening and configured to form a seal between the fluid channel and the fluid chamber in a closed state of the fluid control device; and a seal retention mechanism engaging with the seal and configured to retain the position of the seal in an open state of the fluid control device.

[0032] In some embodiments, the seal includes an O-ring positioned in a recess surrounding an opening formed in a substrate; and the seal retaining mechanism includes a textured layer formed on the surface of the recess; and a bonding layer located between the textured layer and the O-ring, the bonding layer coupling the O-ring in the recess via the textured layer.

[0033] In some embodiments, the seal includes an elastomeric O-ring received in a groove surrounding an opening formed in a substrate; and the seal retention mechanism includes an undercut portion formed at the opening leading to the groove, wherein the size of the opening is smaller than the corresponding size of the elastomeric O-ring, such that the elastomeric O-ring is retained in the groove by the undercut portion.

[0034] In some embodiments, the seal is an elastomeric O-ring, and wherein the seal retaining mechanism includes a groove surrounding an opening formed in a substrate, in which the elastomeric O-ring is received, wherein the inner circumferential portion of the groove is larger than the corresponding size of the O-ring, such that the O-ring is retained in the groove by a compressive force applied by the O-ring to the inner circumferential portion of the groove; or the outer circumferential portion of the groove is smaller than the corresponding size of the O-ring, such that the O-ring is retained in the groove by a tensile force applied by the O-ring to the outer circumferential portion of the groove.

[0035] In some embodiments, a seal is inserted and molded into a substrate. The seal includes: a body portion; a flange portion located at a first end portion of the body portion; a sealing portion located at a second end portion of the body portion; and an opening formed in the body portion. The seal retaining mechanism includes: an undercut portion formed in the body portion of the substrate and configured to engage the flange portion of the seal; and molding material received through the opening in the body portion of the seal and integrally formed between the body portion and the central opening of the substrate.

[0036] In some embodiments, the seal includes: a body portion; a flange portion located at a first end portion of the body portion; a sealing portion located at a second end portion of the body portion extending through a corresponding opening in the substrate; and an opening extending through the body portion from the first end portion to the second end portion of the body portion, and the seal holding mechanism includes: an undercut portion formed in the body portion of the substrate and configured to engage an upper portion of the flange portion of the seal; and a support plate coupled to a bottom portion of the substrate and configured to engage a bottom portion of the flange portion of the seal, such that the flange portion of the seal is held between the substrate and the support plate.

[0037] In some embodiments, the seal includes: a body portion; a flange portion located at a first end portion of the body portion; a sealing portion located at a second end portion of the body portion; and an opening extending through the body portion from the first end portion to the second end portion. The seal holding mechanism includes: a recessed portion formed in an upper portion of a substrate and configured to receive a lower portion of the flange portion of the seal; and a support plate coupled to the upper portion of the substrate and configured to engage the upper portion of the flange portion of the seal such that the flange portion of the seal is held between the support plate and the substrate, wherein the sealing portion of the seal extends through the opening in the support plate.

[0038] In some embodiments, the seal includes: a body portion; a first flange portion located at a first end portion of the body portion; a second flange portion located at a second end portion of the body portion, the second flange portion defining a sealing portion of the seal; and an opening extending through the first flange portion, the body portion, and the second flange portion, and the seal retaining mechanism includes: an undercut portion of the body portion of the substrate positioned to abut against an outer peripheral portion of the body portion of the seal and engaging the first flange portion and the second flange portion.

[0039] In some embodiments, the seal includes: a first sealing portion fixed to a stepped portion of a substrate extending from a body portion of the substrate into at least one fluid channel; and a second sealing portion fixed to a diaphragm, wherein, in a closed state relative to the substrate, the second sealing portion is positioned against the first sealing portion of the seal to block an opening formed in the first sealing portion and close at least one fluid channel; and in an open state relative to the substrate, the second sealing portion of the seal is spaced apart from the first sealing portion, thereby opening an opening formed in the first sealing portion and opening at least one fluid channel.

[0040] In some implementations, the fluid control device is one of a valve device, a pump device, or a combination of a pump and a valve device. Attached Figure Description

[0041] Figure 1 It is a block diagram of an implantable fluid-operated inflatable device based on one aspect.

[0042] Figure 2 A system including an example implantable fluid-operated inflatable device is shown according to one aspect.

[0043] Figure 3A It is a schematic diagram of a fluid architecture based on one aspect of an implantable fluid-operated inflatable device.

[0044] Figure 3B It is a schematic diagram of a fluid architecture based on one aspect of an implantable fluid-operated inflatable device.

[0045] Figure 4A This is an exploded view of an example valve device in a fluid control system based on one aspect of a fluid-operated, fillable device.

[0046] Figure 4B yes Figure 4A The example valve assembly shown is in the closed position (sectional view).

[0047] Figure 4C yes Figure 4A The example valve assembly shown is a cross-sectional view in the open position.

[0048] Figure 5 An example seal retention device according to one aspect is shown.

[0049] Figure 6 An example seal retention device according to one aspect is shown.

[0050] Figure 7A An example seal retention device according to one aspect is shown.

[0051] Figure 7B An example seal retention device according to one aspect is shown.

[0052] Figure 8A This is a perspective view of an example seal retaining device based on one aspect.

[0053] Figure 8B yes Figure 8A The example seal of the example seal retaining device shown is a perspective view.

[0054] Figure 8C It is along Figure 8A The sectional view taken by line AA.

[0055] Figure 8D It is along Figure 8A The sectional view taken by line BB.

[0056] Figure 9A It is a perspective view of an example substrate and an example seal based on one aspect.

[0057] Figure 9B yes Figure 9A An exploded perspective view of the example substrate and example seal shown.

[0058] Figure 9C It is along Figure 9A A cross-sectional view taken from the EE line.

[0059] Figure 10A It is a perspective view of an example substrate and an example seal based on one aspect.

[0060] Figure 10B yes Figure 11A An exploded perspective view of the example substrate and example seal shown.

[0061] Figure 10C It is along Figure 10A The sectional view is taken by the line FF.

[0062] Figure 11A It is a perspective view of an example substrate and an example seal based on one aspect.

[0063] Figure 11B yes Figure 11A The example seal shown is a perspective view.

[0064] Figure 11C It is along Figure 11A The cross-sectional view taken by line GG.

[0065] Figure 12A It is a cross-sectional view of an example seal incorporated into an example valve device in the closed position, based on one aspect.

[0066] Figure 12B It is a cross-sectional view of an example seal incorporated into an example valve device in the open position, based on one aspect. Detailed Implementation

[0067] This document discloses detailed embodiments. However, it should be understood that the disclosed embodiments are merely examples and can be embodied in various forms. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but merely as the basis for the claims and as a representative basis for teaching those skilled in the art to adopt embodiments in various ways in virtually any suitable detailed structure. Furthermore, the terms and phrases used herein are not intended to be limiting, but rather to provide an understandable description of the disclosure.

[0068] As used herein, the term “a” or “an” is defined as one or more. As used herein, the term “another” is defined as at least a second or more. As used herein, the terms “comprising” and / or “having” are defined as including (i.e., open transition words). As used herein, the terms “coupled” or “movably coupled” are defined as a connection, although not necessarily a direct and mechanical connection.

[0069] Generally, the implementation is directed toward implanted devices. The terms "patient" or "user" may be used below for an individual who benefits from the medical device or method disclosed in this disclosure. For example, a patient may be an individual with a medical device implanted in their body, or an individual using the method disclosed in this disclosure to operate the medical device.

[0070] An implantable fluid-operated inflatable device may include a fluid control system. In some examples, the fluid control system includes at least one pump and / or at least one valve and / or at least one combined pump and valve assembly. In some examples, components of the fluid control system control the flow of fluid between a fluid reservoir and an inflatable member of the implantable fluid-operated inflatable device to provide filling / pressurization and venting / depressurization for the inflatable member. In some examples, components of the fluid control system include at least one seal that selectively provides closure and / or opening of a fluid passage between the reservoir and the inflatable member. According to embodiments described herein, an implantable fluid-operated inflatable device includes at least one retaining device incorporated into at least one component of the fluid control system to retain at least one seal in a seated position relative to the component on which the at least one seal is mounted. In some examples, the retaining mechanism includes an undercut in a recess in which the seal is mounted to retain the seal in the recess. In some examples, the retaining mechanism includes a configuration of a recess that places the seal under tension to retain the seal in the recess. In some examples, the retaining mechanism includes a configuration that places the seal in a groove under compression to retain the seal within the groove. In some examples, the retaining mechanism includes an adhesive layer that interacts with an adhesive surface in the groove and a corresponding surface of the seal to retain the seal within the groove. In some examples, the retaining mechanism includes at least one flange formed at an end portion of the seal that interacts with a corresponding surface of a base portion of the component on which the seal is mounted to maintain the position of the seal relative to the base portion of the component.

[0071] Figure 1 This is a block diagram of an example implantable fluid-operated inflatable device 100. Figure 1The illustrated inflatable device 100 includes a fluid reservoir 102, an inflatable member 104, and an electronic control system 108. The electronic control system 108 may interface with a fluid control system 106. The fluid control system 106 may include fluid-like components, such as one or more pumps, one or more valves, and similar components configured to transfer fluid between the fluid reservoir 102 and the inflatable member 104. The fluid control system 106 may include one or more sensing devices that sense conditions within the fluid-like architecture of the inflatable device 100, such as, for example, fluid pressure, fluid flow rate, and similar conditions. In some embodiments, the electronic control system 108 includes components that provide monitoring and / or control of the operation of the various fluid-like components of the fluid control system 106 and / or communication with one or more sensing devices implantable within the fluid-operable inflatable device 100 and / or communication with one or more external devices. In some examples, the electronic control system 108 includes components such as a processor, memory, communication module, power storage device or battery, sensing devices (such as, for example, accelerometers), and other such components configured to provide operation and control of the implantable fluid-operated inflatable device 100. In some examples, the communication module of the electronic control system 108 may provide communication with one or more external devices (such as, for example, an external controller 120).

[0072] In some examples, the external controller 120 includes components such as a user interface, a processor, a memory, a communication module, a power transmission module, and other components that provide for the operation and control of the external controller 120 and communication with the electronic control system 108 of the refillable device 100. For example, the memory may store instructions, applications, and the like that executable by the processor of the external controller 120. The external controller 120 may be configured to receive user input via, for example, a user interface, and transmit that user input to the electronic control system 108 via, for example, a communication module, for the processing, operation, and control of the refillable device 100. Similarly, the electronic control system 108 may transmit operational information to the external controller 120 via a corresponding communication module. This may allow the operational status of the refillable device 100 to be provided to a user, for example, through the user interface of the external controller 120, and may allow diagnostic information to be provided to a doctor, and similar situations.

[0073] In some examples, the power delivery module of the external controller 120 provides power for charging components of the internal electronic control system 108. In some examples, the power delivery for charging the internal electronic control system 108 may alternatively or additionally be provided by an external power delivery device 150 separate from the external controller 120. In some embodiments, the external controller 120 may include sensing devices such as one or more pressure sensors, one or more accelerometers, and other such sensing devices. In some embodiments, the pressure sensors in the external controller 120 may provide, for example, local atmospheric pressure or operating pressure to the internal electronic control system 108 to allow the inflatable device 100 to compensate for pressure variations. In some embodiments, the accelerometers in the external controller 120 may provide detected patient motion to the internal electronic control system 108 for control of the inflatable device 100.

[0074] The fluid reservoir 102, inflatable member 104, electronic control system 108, and fluid control system 106 can be internally implanted into a patient. In some embodiments, the electronic control system 108 and fluid control system 106 are coupled to or incorporated into a housing. In some embodiments, at least a portion of the electronic control system 108 is physically separated from the fluid control system 106. In some embodiments, some modules of the electronic control system 108 are coupled to or incorporated into the fluid control system 106, and some modules of the electronic control system 108 are separated from the fluid control system 106. For example, in some embodiments, some modules of the electronic control system 108 are included in an external device (such as an external controller 120) that communicates with other modules of the electronic control system 108 included within the implantable fluid-operated inflatable device 100. In some embodiments, at least some aspects of the operation of the implantable fluid-operated inflatable device 100 can be manually controlled.

[0075] In some examples, electronic monitoring and control of the implantable fluid-operated refillable device 100 can provide improved patient control over the device, improved patient comfort, and improved patient safety. In some examples, electronic monitoring and control of the implantable fluid-operated refillable device 100 can provide the opportunity for a physician to customize the operation of the refillable device 100 without further surgical intervention. A fluidic architecture defining the flow and control of fluid through the implantable fluid-operated refillable device 100 (including the construction and placement of fluidic components such as pumps, valves, and sensing devices) can allow the refillable device 100 to be precisely monitored and controlled, to respond effectively to user input, and to adapt quickly and efficiently to changing conditions inside the refillable device 100 (changes in pressure and flow rate, etc.) and changing conditions outside the refillable device 100 (pressure surges due to physical activity and impacts, continuous pressure changes due to changes in atmospheric conditions, and other such external condition changes).

[0076] The example implantable fluid-operated inflatable device 100 can represent a variety of different types of implantable fluid-operated devices. For example, Figure 1 The device 100 shown can represent an inflatable penile prosthesis, such as Figure 2 As shown. In some embodiments, Figure 1 The example implantable fluid-operated inflatable device 100 shown can represent other types of implantable inflatable devices that rely on the control of fluid flow to the components of the device to achieve filling, pressurization, venting, depressurization, and deactivation, such as, for example, an artificial urethral sphincter and other such devices.

[0077] Figure 2 An example system is shown, including an example implantable fluid-operated inflatable device 200 (in the form of an example inflatable penile prosthesis). The example inflatable device 200 includes a fluid control system 206 (as described above regarding...). Figure 1 Similar to the described example fluid control system 106, this fluid control system 206 includes fluid components, such as pumps, valves, and sensing devices, positioned within a fluid channel. In some embodiments, the fluid control system includes components such as, for example, one or more fluid control devices, one or more pressure sensors, and other such components. In some embodiments, the example inflatable device 200 includes an electronic control system 208 (similar to the one described above). Figure 1 Similar to the described example electronic control system 108, this electronic control system 208 is configured to provide fluid via fluid-type components in the reservoir 202 (as described above). Figure 1 The described example storage device 102) and the fillable member 204 (as described above) Figure 1The described example allows for the transfer between components 104. Figure 2 In the example shown, the inflatable member 204 is in the form of a pair of inflatable cylinders. Figure 2 In the example shown, the fluid components of the fluid control system 206 and the electronic components of the electronic control system 208 are received in the housing 210. In some embodiments, the fluid components of the fluid control system 206 and the electronic components of the electronic control system 208 received in the housing 210 together define an electronically controlled fluid manifold 230 that provides electronic control over the flow of fluid between the reservoir 202 and the fillable member 204.

[0078] exist Figure 2 In the example shown, the first conduit 203 connects the first fluid port 205 of the electronically controlled fluid manifold 230 (the fluid control system 206 / electronic control system 208 received in the housing 210) to the reservoir 202. One or more second conduits 207 connect one or more second fluid ports 209 of the electronically controlled fluid manifold 230 (the fluid control system 206 / electronic control system 208 received in the housing 210) to an inflatable member 204 in the form of an inflatable cylinder. In some examples, the electronic control system 208 may communicate with an external controller 220 (as described above) via a corresponding communication module. Figure 1 (Similar to the described external controller 120) communication. For example, an application stored in memory and executed by the processor of the external controller 220 can allow users and / or physicians to operate, observe, monitor, and modify the operation of the refillable device 200. In some examples, components of the electronic control system 208 and / or the fluid control system 206 can be charged and / or recharged by the power delivery module of the external controller 220 and / or by a power delivery device 250 separate from the external controller 220.

[0079] The principles described herein apply to example implantable fluid-operated inflatable devices (such as...) Figure 2 The examples shown are in the form of inflatable penile prostheses, as well as other types of implantable fluid-operated inflatable devices that rely on pump and valve assemblies comprising various fluid components to provide fluid transfer between different fluid-filled implantable components, thereby enabling filling, venting, pressurizing, depressurizing, deactivating, and occluding for effective operation. Figure 2 The illustrated example implantable fluid-operated inflatable device 200 includes an electronic control system 208 to provide control over the operation of a corresponding inflatable member 204 in cylindrical form, and to monitor and control the pressure and / or fluid flow through the inflatable member 204. Some of the principles described herein can also be applied to manually controlled implantable fluid-operated inflatable devices.

[0080] As noted above, the electronic control system 208, which controls the flow of fluid between the reservoir 202 and the inflatable member 204 for filling, pressurizing, venting, and depressurizing the inflatable member 204, can provide improved patient control, improved operational precision, improved patient comfort, and improved patient safety for the inflatable device 200. In some cases, this improved control and precision in the operation of the inflatable device 200 may rely on the accurate operation and control of components within the fluid control system 206 and / or the electronically controlled fluid manifold 230. Thus, in some embodiments, the electronically controlled fluid manifold 230 includes a fluid control system 206 having one or more pumps and / or valves. Precise and consistent operation of the components of the pumps and / or valves can produce the desired precise flow control, as well as consistent filling, venting, pressurizing, depressurizing, deactivating, and occluding for efficient operation.

[0081] A fluid control system according to embodiments described herein may include a pump assembly comprising, for example, one or more pump and valve devices and / or combined pump and valve devices within a fluid circuit of the pump assembly to control the transfer of fluid between a fluid reservoir and an inflatable member. In some examples, the pump assembly comprising one or more pump and valve devices and / or combined pump and valve devices is electronically controlled. In examples where the pump assembly is electronically powered and / or controlled, the pump assembly may include an airtight manifold capable of containing fluid flow and isolating it from the electronic components of the pump assembly to prevent leakage and / or gas exchange. In some examples, one or more pump and valve devices and / or combined pump and valve devices include piezoelectric elements. In some examples, the pump assembly includes one or more pressure sensing devices in the fluid circuit to provide relatively accurate monitoring and control of fluid flow and / or fluid pressure within the fluid circuit and / or inflatable member. A fluid circuit configured in this manner can facilitate the proper filling, venting, pressurizing, depressurizing, and deactivating of components of an implantable fluid-operated device to provide for patient safety and device efficiency.

[0082] Figure 3A This is a schematic diagram of an example fluidic architecture for an implantable fluid-operated inflatable device, based on one aspect. Figure 3B This is a schematic diagram of an example fluidic architecture for an implantable fluid-operated inflatable device, according to one aspect. The fluidic architecture of the implantable fluid-operated inflatable device may include, in addition to... Figure 3A and Figure 3B Other arrangements of fluid channels, pumps / valves, pressure sensors, and other components besides those shown in the example.

[0083] Figure 3AThe example fluid architecture shown includes a first pump P1 and a first valve V1, which are positioned in a first fluid passage between the reservoir 202 and the inflatable member 204 to control the flow of fluid from the reservoir 202 to the inflatable member 204. Figure 3A The illustrated fluidic architecture includes a second pump P2 and a second valve V2 positioned in a second fluid passage between the inflatable member 204 and the reservoir 202 to control the flow of fluid from the inflatable member 204 to the reservoir 202. Figure 3B As shown, in some examples, a first pump and a first valve are included in a combined pump and valve assembly PV1 disposed in a first fluid passage, and a second pump and a second valve are included in a second combined pump and valve assembly PV2 disposed in a second fluid passage. The fluid architecture of an implantable fluid-operated fillable device may include, in addition to... Figure 3A and 3B Other arrangements of fluid channels, pumps / valves, pressure sensors and other components not shown.

[0084] exist Figure 3A In the illustrated fluidic architecture, the first pump P1 and the first valve V1 operate to pump fluid from the reservoir 202 through a first fluid passage to the fillable member 204 to provide filling of the fillable member 204, while the second valve V2 closes the second fluid passage to provide backflow to prevent fluid from flowing back to the reservoir 202. The second pump P2 and the second valve V2 operate to pump fluid from the fillable member 204 through the second fluid passage to the reservoir 202 to provide venting for the fillable member 204, while the first valve V1 closes the first fluid passage to prevent backflow of fluid to the fillable member 204.

[0085] exist Figure 3BIn the illustrated example arrangement, the first combined pump and valve assembly PV1 and the second combined pump and valve assembly PV2 can operate in a first mode to fill or pressurize the fillable member 204; and can operate in a second mode to vent or repressurize the fillable member 204. In the first operating mode, the first combined pump and valve assembly PV1 delivers fluid from the reservoir 202 to the fillable member 204, while the second combined pump and valve assembly PV2 remains closed / inoperable to prevent fluid from flowing from the fillable member 204 toward the reservoir 202, thereby preventing venting / depressurization. The first combined pump and valve assembly PV1 can remain operational to pump fluid to the fillable member 204 until the desired pressure is reached. Once the desired pressure is reached, the first combined pump and valve assembly PV1 can be closed to maintain the fillable member 204 at the desired pressure / fill state. In the second operating mode, the second combined pump and valve assembly PV2 delivers fluid from the fillable member 204 to the reservoir 202, while the first combined pump and valve assembly PV1 remains closed / inoperable to prevent fluid flow from the reservoir 202 toward the fillable member 204, thereby preventing filling / pressurization. The second combined pump and valve assembly PV2 can remain operational to pump fluid to the reservoir 202 until the desired pressure is reached at the fillable member 204. Once the desired pressure is reached, the second combined pump and valve assembly PV2 can be closed to maintain the fillable member 204 at the desired pressure / venting state.

[0086] Figure 4A This is a partially exploded perspective view of an example valve device 400 according to the embodiments described herein. Figure 4B and Figure 4C yes Figure 4A The example valve device 400 shown is in an assembled state, and its operation is illustrated. Figures 4A-4C The example valve device 400 shown is an example of a fluid control device or fluid component that can be included in the fluid control system 206 of the example electronically controlled fluid manifold 230 described above.

[0087] exist Figures 4A-4C In the illustrated example arrangement, the example valve device 400 includes a substrate 410 defining a base portion of the valve device 400. A diaphragm 420 is positioned on the substrate 410. A piezoelectric element 440 is positioned on the diaphragm 420, wherein an insulating layer 430 is positioned between the diaphragm 420 and the piezoelectric element 440. In some examples, an epoxy layer 432 provides coupling for the insulating layer 430 on the diaphragm 420. In some examples, an epoxy layer 434 provides coupling for the piezoelectric element 440 on the insulating layer 430. In some examples, one or more electrodes 490 are arranged on the example valve device 400. Figure 4AIn the example shown, the example valve device 400 includes a pair of electrodes 490 coupled between an insulating layer 430 and a piezoelectric element 440. Applying a voltage to the piezoelectric element 440 causes deflection or deformation of the piezoelectric element 440 and a corresponding deflection or deformation of the diaphragm 420 and the insulating layer 430 coupled thereto. Applying voltage in this way causes the valve device 400 to... Figure 4B The closing position shown is the same as Figure 4C The valve device 400 moves between the shown open positions. In some examples, voltage is alternately applied to the piezoelectric element 440, causing the valve device 400 to alternate between the closed and open positions, so that the valve device 400 can also perform a pumping function.

[0088] exist Figures 4A-4C In the illustrated example arrangement, a fluid chamber 480 is defined between a substrate 410 and a diaphragm 420. The substrate 410 includes a first opening 411 providing communication between a first fluid channel 413 and the fluid chamber 480. The substrate 410 includes a second opening 412 providing communication between a second fluid channel 414 and the fluid chamber 480. Figures 4A-4C In the example arrangement shown, the substrate 410 includes a recess 415 surrounding the first opening 411, wherein... Figures 4A-4C In the example shown, the seal 450 in the form of an O-ring is fitted into the groove 415.

[0089] In the closed position of the example valve assembly 400, the top portion of the seal 450 is pressed against the diaphragm 420, as... Figure 4B As shown. This positioning of the seal 450 against the diaphragm 420 closes the chamber 480 and inhibits the flow of fluid through the chamber 480 between the first fluid passage 413 and the second fluid passage 414 through the example valve device 400. In the open position of the example valve device 400, the top portion of the seal 450 separates from or is spaced apart from the diaphragm 420 due to the deflection of the diaphragm 420. This positioning of the seal 450 relative to the diaphragm 420 opens the chamber 480 and allows fluid to flow through the fluid chamber 480 between the first fluid passage 413 and the second fluid passage 414 through the example valve device 400.

[0090] In the open position of the example valve device 400, the flow of fluid in chamber 480 in multiple directions can generate eddies that exert forces on seal 450. In some examples, the force applied to seal 450 in this way can cause movement of seal 450. In some examples, the force applied to seal 450 in this way can change the position of seal 450 in the recess. For example, the force applied to seal 450 in this way can lift seal 450 from its seated position in recess 415. In some cases, lifting seal 450 from its seated position in recess 415 when the example valve device 400 is in the open position can inhibit or impede the flow of fluid through chamber 480. Inhibition or impediment of the flow of fluid through the example valve device 400 can then adversely affect the filling / pressurization and / or venting / depressurization of fillable member 204 as intended. Therefore, obstructed flow of fluid through the example valve device 400 may adversely affect the overall effective operation of the implantable fluid-operated inflatable device in which it is installed, and may adversely affect patient comfort and safety.

[0091] According to the embodiments described herein, the valve device includes a seal retention mechanism. The seal retention mechanism holds the seal in position relative to the component on which it is mounted, so as to maintain the function of the component as intended. Hereinafter, for the purposes of discussion and illustration, an example retention mechanism will be described with respect to the example valve device 400 described above. The principles described herein are applicable to other components, devices, and the like that will benefit from positive retention of the seal.

[0092] Figure 5 An example seal and a seal retention mechanism 500 according to the embodiments described herein are shown. Hereinafter, for the purposes of discussion and illustration, the example seal retention mechanism 500 will be described with respect to its incorporation into the example valve assembly 400 described above. The principles to be described with respect to the example seal retention mechanism 500 are applicable to other fluid control components that will benefit from positive seal retention, such as, for example, other valve assemblies, pump assemblies, combined pump and valve assemblies, and similar components.

[0093] Figure 5 This is a close-up view of a seal 450 in the form of an O-ring, received in a recess 415 surrounding a first opening 411 / first fluid channel 413 formed in a substrate 410. Figure 5In the example shown, the seal retaining mechanism 500 includes a textured layer 515 formed along a surface portion of a recess 415, and a bonding layer 525 disposed between the textured layer 515 and a corresponding seating surface of the seal 450. In some examples, the textured layer 515 provides an irregular or non-uniform surface to facilitate bonding and adhesion with the bonding layer 525. In some examples, the bonding layer 525 includes an adhesive material, such as, for example, an epoxy material, a resin material, and similar materials, which will form a bond between the seal 450 and the textured layer 515 in the recess 415 and retain the seal 450 in a seated position within the recess 415. In some examples, the textured layer 515 is formed by, for example, a laser ablation process applied to a surface portion of the recess 415, a machining process applied to a surface portion of the recess 415, or other such processes. In some examples, the irregular or non-uniform texture of the textured layer 515 includes nodules and / or cracks and / or buckles and / or pores, etc. In some examples, the texturing provided by these features of texture layer 515 facilitates mechanical adhesion to the material of bonding layer 525. Figure 5 In the example shown, simply for discussion and illustration purposes, the texture layer 515 is formed on the lower surface of the groove 415 (in Figure 5 (In the example orientation shown). In some examples, the texture layer 515 is formed on other surface portions of the groove 415—instead of the bottom surface of the groove 415 or in addition to the bottom surface of the groove 415. In some examples, the corresponding coupling surface or mating surface of the seal 450 (now in Figure 5 (As shown in the figure) can be modified to enhance the bond between the seal 450 and the bonding layer 525.

[0094] Figure 6 An example seal and a seal retention mechanism 600 according to an embodiment described herein are shown. Hereinafter, for the purposes of discussion and illustration, the example seal retention mechanism 600 will be described with respect to its integration into a substrate of an example valve device (such as the example valve device 400 described above). The principles to be described with respect to the example seal retention mechanism 600 are applicable to other fluid control components that will benefit from positive seal retention, such as, for example, other valve devices, pump devices, combined pump and valve devices, and similar components.

[0095] Figure 6 This is a close-up view of a seal 450 in the form of an O-ring, received in a groove 615, which is formed in a substrate 610 of a fluid-type component (such as, for example, the example valve device 400 described above, or other such fluid-type components). The groove 615 surrounds an opening 611 formed in the substrate 610, which receives a fluid chamber ( Figure 6(Not shown) is connected to fluid channel 613 (similar to the first opening 411 in substrate 410, connecting chamber 480 to fluid channel 413 of example valve device 400). In Figure 6 In the example shown, the seal holding mechanism 600 is provided by the engagement or interaction of the undercut portion 625 of the groove 615 with the seal 450 in the form of an O-ring. That is, the size D1 of the opening leading to the groove 615 defined at the undercut portion 625 is smaller than the corresponding size D2 of the seal 450. In this example, the seal 450 is made of a compliant material, such as an elastomer, which deforms to fit through the opening defined by the undercut portion 625 of the groove 615. After the seal 450 is inserted into the groove 615 through the opening defined by the undercut portion 625, the seal 450 returns to its original shape / construction. In this state, the seal 450 is held in the groove 615 by the undercut portion 625, and specifically by the smaller size D1 of the undercut portion 625 of the groove 615 compared to the corresponding size D2 of the seal 450.

[0096] Figure 7A An example seal and a seal retention mechanism 700A according to an embodiment described herein are shown. Hereinafter, for the purposes of discussion and illustration, the example seal retention mechanism 700A will be described with respect to its integration into a substrate of an example valve device (such as the example valve device 400 described above). The principles described with respect to the example seal retention mechanism 700A are applicable to other fluid control components that will benefit from positive seal retention, such as, for example, other valve devices, pump devices, combined pump and valve devices, and similar components.

[0097] Figure 7A This is a close-up view of a seal 450 in the form of an O-ring, received in a recess 715, which is formed in a substrate 710 of a fluid-type component (such as, for example, the example valve device 400 described above, or other such fluid-type components). The recess 715 surrounds an opening 711 formed in the substrate 710, which receives a fluid chamber ( Figure 7A (Not shown) is connected to fluid channel 713 (similar to the first opening 411 in substrate 410, connecting chamber 480 to fluid channel 413 of example valve device 400). In Figure 7A In the example shown, the seal retention mechanism 700A is provided by the interaction between the seal 450 and the inner circumferential portion 715A of the groove 715. For example, in an example arrangement where the groove 715 is a substantially circular groove formed in the substrate 710 surrounding the opening 711, the inner circumferential portion 715A of the groove 715 may correspond to either the inner diameter portion or the inner circumferential portion of the groove 715. Figure 7A In the arrangement shown, the elasticity of the seal 450 (e.g., the elastomeric material of the seal 450) allows the seal 450 to be pulled or stretched to be inserted into the recess 715 through the open upper portion 717. Once inserted into the recess 715, the elasticity of the seal 450 causes the seal 450 to... Figure 7A The direction of arrow T shown is inward retraction or pulling. For example, the dimension (e.g., diameter) of the seal 450 in its resting state may be smaller than the corresponding dimension of the inner circumferential portion 715A of the groove 715, such that once located in the groove 715, the seal 450 contracts and returns to its resting state due to the elastic properties of the seal 450. Therefore, in Figure 7A In the arrangement shown, the seal 450 is under tension, a tensile force is applied to the inner circumferential portion 715A of the groove 715 in the direction of arrow T, and the seal 450 is held in the groove 715. In some examples, the open upper portion 717 of the groove 715 may include the features described above. Figure 6 The described undercut portion is to provide additional retention of the seal 450 in the groove 715.

[0098] Figure 7B This is a close-up view of a seal 450 in the form of an O-ring, received in a groove (such as one formed in...). Figure 7A The substrate 710 is located in a recess 715. The substrate 710 can be incorporated into a fluid-type component, such as, for example, the example valve device 400 described above, or other such fluid-type components. Figure 7B In the example shown, the seal retention mechanism 700B is provided by the interaction between the seal 450 and the outer peripheral portion 715B of the groove 715. For example, in an example arrangement where the groove 715 is a generally circular groove formed in the substrate 710 surrounding the opening 711, the outer peripheral portion 715B of the groove 715 may correspond to the outer diameter portion or the outer circumferential portion of the groove 715. Figure 7B In the arrangement shown, the elasticity of the seal 450 allows the seal 450, made of an elastomeric material, to be compressed, squeezed, or deformed for insertion into the recess 715 through the open upper portion 717. Once inserted into the recess 715, the elasticity of the seal 450 causes it to expand or return to its original shape. Figure 7B Arrow C, as shown, applies a compressive force to the outer peripheral portion 715B of the groove. For example, the dimension (e.g., diameter) of the seal 450 in its resting state may be larger than the corresponding dimension of the outer peripheral portion 715B of the groove 715, such that once located in the groove 715, the seal 450 expands and returns to its resting state due to the elastic properties of the seal 450. Therefore, in Figure 7BIn the arrangement shown, the seal 450 is compressed within the recess 715 to apply force to the outer peripheral portion 715B of the recess 715 in the direction of arrow C, and to retain the seal 450 within the recess 715. In some examples, the open upper portion 717 of the recess 715 may include, as described above... Figure 6 The described undercut portion is to provide additional retention of the seal 450 in the groove 715.

[0099] In some examples, the seal may be co-manufactured with the substrate of the fluid component. Figures 8A-8D The example arrangement shown illustrates a seal that is inserted into a substrate, where insert molding provides positive retention of the seal relative to the substrate. Therefore, Figures 8A-8D A retaining mechanism 800 is shown, provided by inserting a seal into a molded substrate. Specifically, Figure 8A This is a perspective view of the inserted molded substrate 810 and seal 850. Figure 8B This is a perspective view of example seal 850. Figure 8C It is along Figure 8A A sectional view taken by line AA; and Figure 8D It is along Figure 8A The sectional view taken by line BB shows the retaining mechanism 800 provided by inserting the seal 850 into the substrate 810.

[0100] The substrate 810 includes: a chamber ( Figures 8A-8D (Not shown) connected to the first opening 811 of the first fluid channel 813 (similar to the first opening 411 in the substrate 410, connecting the chamber 480 to the first fluid channel 413 of the example valve device 400); connecting the chamber (in Figures 8A-8D (Not shown in the diagram) A second opening 412 connects to the second fluid channel 814 (similar to the second opening 412 in the substrate 410, connecting the chamber 480 to the second fluid channel 414 of the example valve device 400). In Figures 8A-8D In the example shown, the seal retention mechanism 800 is provided by positive retention of the seal 850 in the substrate 810 due to the insertion molding of the seal 850 in the substrate 810.

[0101] exist Figures 8A-8D In the illustrated example arrangement, the seal 850 includes: a body portion 852, wherein a flange portion 854 extends outwardly (e.g., radially outwardly) from a first end portion of the body portion 852, and a sealing portion 856 is disposed at a second end portion of the body portion 852. Figures 8A-8DIn the example shown, the main body portion 852 of the seal 850 surrounds a first fluid channel 813 defined by the substrate 810. In some examples, the seal 850 includes an opening 858. Figures 8A-8D In the example shown, an opening 858 is formed in the body portion 852 of the seal 850 to provide a portion defining a first fluid channel 813 for molding material to flow from the body portion 815 of the substrate 810 to the substrate 810, such that the substrate 810 and the seal 850 can be integrally formed. Figures 8A-8D In the illustrated example arrangement, the flange portion 854 of the seal 850 provides a seating surface for the seal 850, which mates with an undercut portion 825 formed in the substrate 810. The undercut portion 825 of the substrate 810 (formed in the molding of the substrate 810 by molding material received in the region of the undercut portion 825) engages the flange portion 854 of the seal 850 to form a holding mechanism 800 that positively holds the seal 850 in position relative to the substrate 810. The seal 850 is further held by material received in an opening 858 in the body portion 852 of the seal 850, which integrally forms the body portion 815 of the substrate 810 and the first fluid channel 813.

[0102] In some examples, the seal can be mechanically held within the substrate of the fluid component. Figures 9A-9C The example arrangement shown illustrates a seal that is mechanically held within a substrate to provide positive retention of the seal relative to the substrate. Therefore, Figures 9A-9C A retaining mechanism 900 provided by mechanical coupling from a seal to a substrate is shown. Specifically, Figure 8A This is a perspective view of the substrate 910 and the seal 950. Figure 9B yes Figure 9A An exploded perspective view of the substrate 910 and the seal 950 shown. Figure 9C It is along Figure 9A The cross-sectional view taken along the EE line shows the retaining mechanism 900 provided by the mechanical coupling of the seal 950 and the substrate 910.

[0103] The substrate 910 includes: a chamber ( Figures 9A-9C (Not shown) A first opening 911 connected to a first fluid channel 913 (similar to the first opening 411 in substrate 410, connecting chamber 480 to the first fluid channel 413 of example valve device 400); and a chamber connected to a second fluid channel ( Figures 9A-9C The second opening 912 (not shown in the image). Figures 9A-9CIn the example shown, since the support plate 980 is coupled to the attachment of the substrate 910, with the seal 950 positioned between them, the seal retention mechanism 900 is provided by positive retention of the seal 950 relative to the substrate 910.

[0104] exist Figures 9A-9C In the illustrated example arrangement, the seal 950 includes: a body portion 952, wherein a flange portion 954 extends outward (e.g., radially outward) from a first end portion of the body portion 952; and a sealing portion 956 is disposed at a second end portion of the body portion 952. Figures 9A-9C In the example shown, the body portion 952 of the seal 950 is positioned in the first opening 911 and extends along an inner portion of the first fluid channel 913. A support plate 980 is coupled to the substrate 910, with the seal 950 positioned between them to provide positive retention of the seal 950 relative to the substrate 910. In some examples, the support plate 980 includes a first opening 981 corresponding to a first opening 911 in the substrate 910 and a first fluid channel 913 passing through the body portion 952 of the seal 950; and includes a second opening 982 corresponding to a second opening 912 in the substrate 910. Figures 9A-9C In the example shown, simply for discussion and illustration purposes, the support plate 980 is coupled to the substrate 910 via at least one weld 970. Other coupling means may be used to couple the support plate 980 to the substrate 910.

[0105] exist Figures 9A-9C In the illustrated example arrangement, the flange portion 954 of the seal 850 provides a seating surface for the seal 950, which engages with an undercut portion 925 formed in the substrate 910. This interface between the flange portion 954 of the seal 950 and the undercut portion 925 of the substrate 910, together with the coupling of the support plate 980 to the bottom portion of the substrate 910 and the bottom portion of the flange portion 954 of the seal 950, forms a holding mechanism 900 that positively maintains the position of the seal 950 relative to the substrate 910.

[0106] Figures 10A-10C A retaining mechanism 1000 provided by mechanical coupling from a seal to a substrate is shown. Specifically, Figure 10A This is a perspective view of the substrate 1010 and the seal 1050. Figure 10B yes Figure 10A An exploded perspective view of the substrate 1010 and the seal 1050 shown. Figure 10C It is along Figure 10A The sectional view taken by line FF shows the retaining mechanism 1000 provided by the mechanical coupling of the seal 1050 and the substrate 1010.

[0107] The substrate 1010 includes a first opening 1011 and a second opening 1012, similar to the first opening 411 and second opening 412 in the substrate 410, to connect the chamber 480 to the first fluid passage 413 of the example valve device 400. Figures 10A-10C In the example shown, since the support plate 1080 is coupled to the attachment of the substrate 1010, with the seal 1050 positioned between them, the seal retention mechanism 1000 is provided by positive retention of the seal 1050 relative to the substrate 1010.

[0108] exist Figures 10A-10C In the illustrated example arrangement, the seal 1050 includes: a body portion 1052, wherein a flange portion 1054 extends outward (e.g., radially outward) from a first end portion of the body portion 1052; and a sealing portion 1056 is disposed at a second end portion of the body portion 1052. Figures 10A-10C In the example shown, the flange portion 1054 of the seal 1050 is positioned within the undercut portion 1025 of the substrate 1010, wherein the body portion 1052 of the seal 1050 extends upward (in Figure 10C In the example orientation shown, the seal is positioned in the first opening 1011 and extends through the first opening 1081 in the support plate 1080. In this example arrangement, the main body portion 1052 of the seal extends along the inner portion of the first fluid channel 1013. The support plate 1080 is coupled in a recess 1015 formed in the upper portion of the substrate 1010 (in... Figure 10C In the illustrated example orientation, a seal 1050 is positioned between the two to provide positive retention of the seal 1050 relative to the substrate 1010. In some examples, the support plate 1080 includes a first opening 1081 corresponding to a first opening 1011 in the substrate 1010 and a first fluid channel 1013 passing through the body portion 1052 of the seal 1050. In some examples, the support plate 1080 includes a second opening 1082 corresponding to a second opening 1012 in the substrate 1010. Figures 10A-10C In the example shown, simply for discussion and illustration purposes, the support plate 1080 is coupled to the substrate 1010 via at least one weld 1070. Other coupling means may be used to couple the support plate 1080 to the substrate 1010.

[0109] exist Figures 10A-10CIn the illustrated example arrangement, the flange portion 1054 of the seal 1050 provides a seating surface for the seal 1050, which mates with or engages with the undercut portion 1025 formed in the substrate 1010. This interface between the flange portion 1054 of the seal 1050 and the undercut portion 1025 of the substrate 1010, together with the coupling of the support plate 1080 to the recess 1015 formed in the upper portion of the substrate 1010 and the upper portion of the flange portion 1054 of the seal 1050, forms a holding mechanism 1000 that positively maintains the position of the seal 1050 relative to the substrate 1010.

[0110] Figures 11A-11C A retaining mechanism 1100 provided by a press fit or interference fit between the seal and the substrate is shown. Specifically, Figure 11A This is a perspective view of the substrate 1110 and the seal 1150. Figure 11B yes Figure 11A A perspective view of the seal 1150 shown. Figure 11C It is along Figure 11A The sectional view taken by line GG shows the retaining mechanism 1100 provided by the press fit or interference fit of the seal 1150 and the substrate 1110.

[0111] The substrate 1110 includes a first opening 1111 and a second opening 1112, similar to the first opening 411 and the second opening 412 in the substrate 410, to connect the chamber 480 to the first fluid passage 413 of the example valve device 400. Figures 11A-11C In the example shown, the seal retention mechanism 1100 is provided by positive retention of the seal 1150 relative to the substrate 1110 due to the press fit or interference fit of the seal 1150 in the substrate 1110 and the interaction between the flange portion of the seal and the opposite side surface of the substrate 1110.

[0112] exist Figures 11A-11C In the illustrated example arrangement, seal 1150 includes: a body portion 1052, wherein a first flange portion 1154 extends outwardly (e.g., radially outwardly) from a first end portion of body portion 1152, and a second flange portion 1156 extends outwardly (e.g., radially outwardly) from a second end portion of body portion 1152. At least one of the first flange portion 1154 or the second flange portion 1156 of seal 1150 may define a sealing portion of seal 1150. Figures 11A-11CIn the example shown, the undercut portion 1125 of the substrate 1110 is positioned between the first flange portion 1154 and the second flange portion 1156 of the substrate 1110, and is adapted to abut against the body portion 1152 of the seal 1150. In this example arrangement, the body portion 1152 of the seal 1150 is positioned in the first opening 1111 and extends along the interior of the first fluid channel 1113.

[0113] In some examples, the seal 1150 is a pre-molded insert made of an elastomeric material deformable to be inserted into a first opening 1111 in the substrate 1110. In some examples, the seal 1150 is overmolded into the substrate 1110. In this example arrangement, the interaction between the first flange portion 1154 and a corresponding recessed area defined by the undercut portion 1125 of the substrate 1110, together with the interaction between the second flange portion 1156 and a corresponding recessed area defined by the undercut portion 1125 of the substrate 1110, defines a retaining mechanism 1100 that holds the seal 1150 orally in the substrate 1110.

[0114] Figure 12A and Figure 12B This is a cross-sectional view showing the example seal 1250 incorporated into the example valve assembly 400 described above. Simply for discussion and illustration purposes, Figure 12A and Figure 12B An example valve assembly 400 is shown. The principles described herein can be applied to other types of fluid components, such as pump assemblies, combined pump and valve assemblies, and similar devices, as well as other such components that will benefit from the retention of sealing devices during fluid flow operation.

[0115] Figure 12A An example valve device 400 in the closed position is shown. Figure 12BAn example valve device 400 in the open position is shown. A seal 1250 is mounted in a first fluid passage 413, which is formed to communicate with the fluid chamber 480 of the valve device 400 via a first opening 411 in a substrate 410. The seal 1250 includes a first sealing portion 1251 mounted on a stepped portion 1225 of the substrate 410. The stepped portion 1225 extends inward (e.g., radially inward) from a wall portion of the first fluid passage toward a central portion of the first fluid passage. The first sealing portion 1251 can be secured to the stepped portion 1225 of the substrate 410 in any number of ways, including, for example, adhesives, epoxy resins, or other such binders. The seal 1250 includes an inwardly facing second sealing portion 1252 secured to a diaphragm 420 at a location corresponding to the first sealing portion 1251. The second sealing portion 1251 can be secured to the diaphragm 420 in any number of ways, including, for example, adhesives, epoxy resins, or other such binders. The second sealing portion 1252 is configured to selectively contact the first sealing portion 1251 in order to selectively open and close the first fluid passage 413.

[0116] exist Figure 12A and Figure 12B In the illustrated example arrangement, the first sealing portion 1251 includes an opening 1253. The opening 1253 in the first sealing portion 1251 is aligned with the opening defined by the stepped portion 1225 of the substrate 410 and the first fluid channel 413. Figure 12A In the closed position shown, the piezoelectric element 440 (and the insulating layer 430 and diaphragm 420 coupled thereto) is not deformed or deflected. In the undeformed or undeflected state of the piezoelectric element 440, the second sealing portion 1252 extends downward through the first opening 411 and into the first fluid passage 413, wherein the second sealing portion 1252 is positioned against the first sealing portion 1251, thereby closing the opening 1253 in the first sealing portion 1251. Closing the opening 1253 in the first sealing portion 1251 in this manner blocks the flow of fluid between the first fluid passage 413 and the fluid chamber 480, thereby closing the example valve device 400.

[0117] Figure 12BThe diagram illustrates the deflection or deformation state of the piezoelectric element 440 (and the insulating layer 430 and diaphragm 420 coupled thereto). In the deflection or deformation state of the piezoelectric element 440, the second sealing portion 1252, together with the diaphragm 420 coupled thereto, moves away from the first sealing portion 1251. Therefore, in the deflection or deformation state of the piezoelectric element, the second sealing portion 1252 is spaced apart from the first sealing portion 1251. This movement of the second sealing portion 1252 away from the first sealing portion 1251 opens the opening 1253 in the first sealing portion 1251, thereby opening the example valve device 400 and allowing fluid to flow between the first fluid passage 413 and the fluid chamber 480. Figure 12A and Figure 12B In the example arrangement shown, due to the coupling of the first sealing portion 1251 to the stepped portion 1225 of the substrate 410 and the coupling of the second sealing portion 1252 to the diaphragm 420, the example seal 1250 is held in the positive direction when fluid flows through the fluid chamber 480.

[0118] While certain features of the described embodiments have been illustrated herein, many modifications, substitutions, alterations, and equivalents will now occur to those skilled in the art. Therefore, it should be understood that the appended claims are intended to cover all such modifications and alterations that fall within the scope of the embodiments.

Claims

1. A fluid control system for an implantable fluid-operated inflatable device, comprising: case; At least one fluid channel is defined within the housing; A fluid control device, positioned in the at least one fluid channel, comprising: substrate; A diaphragm is coupled to the substrate; A fluid chamber defined between the substrate and the diaphragm; An opening is formed in the substrate, the opening connecting the fluid chamber to the fluid passage of the fluid control device; A seal, disposed at the opening and configured to form a seal between the fluid passage and the fluid chamber when the fluid control device is closed; and A seal retention mechanism engages with the seal and is configured to retain the position of the seal in the open state of the fluid control device.

2. The fluid control system according to claim 1, wherein, The seal includes: an O-ring positioned in a groove surrounding the opening formed in the substrate; and The seal retention mechanism includes: The textured layer formed on the surface of the groove; and A bonding layer is located between the textured layer and the O-ring, the bonding layer coupling the O-ring into the groove via the textured layer.

3. The fluid control system according to claim 1 or claim 2, wherein, The seal includes: an elastomeric O-ring received in a groove surrounding the opening formed in the substrate; and The seal retention mechanism includes an undercut portion formed at an opening leading to the groove, wherein the size of the opening is smaller than the corresponding size of the elastomeric O-ring, such that the elastomeric O-ring is retained in the groove by the undercut portion.

4. The fluid control system according to any one of claims 1 to 3, wherein, The seal is an elastomeric O-ring, and wherein the seal retention mechanism includes a groove surrounding the opening formed in the substrate, in which the elastomeric O-ring is received, wherein... The inner circumferential portion of the groove is larger than the corresponding size of the O-ring, such that the O-ring is held in the groove by the compressive force applied by the O-ring to the inner circumferential portion of the groove; or The outer periphery of the groove is smaller than the corresponding size of the O-ring, such that the O-ring is held in the groove by the tensile force applied by the O-ring to the outer periphery of the groove.

5. The fluid control system according to claim 1, wherein, The seal is inserted into the substrate and molded into it. The seal includes: Main body; The flange portion located at the first end portion of the main body portion; The sealing portion located at the second end portion of the main body; and The opening formed in the main body portion, and The seal retention mechanism includes: An undercut portion, said undercut portion being formed in the main body portion of the substrate and configured to engage the flange portion of the seal; and A molding material is received through an opening in the body portion of the seal and is integrally formed between the body portion and the central opening of the substrate.

6. The fluid control system according to claim 1, wherein, The sealing element includes: Main body; The flange portion located at the first end portion of the main body portion; A sealing portion located at the second end portion of the main body, the sealing portion extending through a corresponding opening in the substrate; and Extending from the first end portion to the second end portion of the main body portion through the opening of the main body portion, and The seal retention mechanism includes: An undercut portion, said undercut portion being formed in the main body portion of the substrate and configured to engage the upper portion of the flange portion of the seal; and A support plate is coupled to the bottom portion of the substrate and configured to engage the bottom portion of the flange portion of the seal, such that the flange portion of the seal is held between the substrate and the support plate.

7. The fluid control system according to claim 1, wherein, The sealing element includes: Main body; The flange portion located at the first end portion of the main body portion; The sealing portion located at the second end portion of the main body; and Extending from the first end portion to the second end portion of the main body portion through the opening of the main body portion, and The seal retention mechanism includes: A recessed portion, the recessed portion being formed in the upper portion of the substrate and configured to receive the lower portion of the flange portion of the seal; and A support plate is coupled to an upper portion of the substrate and configured to engage an upper portion of a flange portion of the seal, such that the flange portion of the seal is held between the support plate and the substrate, wherein a sealing portion of the seal extends through an opening in the support plate.

8. The fluid control system according to claim 1, wherein, The sealing element includes: Main body; The first flange portion is located at the first end portion of the main body portion; A second flange portion located at the second end portion of the main body portion, the second flange portion defining a sealing portion of the seal; and An opening extending through the first flange portion, the main body portion, and the second flange portion, and The sealing member retaining mechanism includes: an undercut portion of the main body portion of the substrate, which is positioned to abut against the outer peripheral portion of the main body portion of the sealing member, and engages the first flange portion and the second flange portion.

9. The fluid control system according to claim 1, wherein, The sealing element includes: A first sealing portion, the first sealing portion being fixed to a stepped portion of the substrate, the stepped portion extending from the main body portion of the substrate into the at least one fluid channel; and The second sealing portion, which is fixed to the diaphragm, wherein... In the closed state of the diaphragm relative to the substrate, the second sealing portion is positioned against the first sealing portion of the seal to block the opening formed in the first sealing portion and close the at least one fluid passage; and In the open state of the diaphragm relative to the substrate, the second sealing portion is spaced apart from the first sealing portion of the seal, thereby opening the opening formed in the first sealing portion and opening the at least one fluid channel.

10. The fluid control system according to any one of the preceding claims, wherein, The fluid control device is one of a valve device, a pump device, or a combination of a pump and a valve device.

11. An implantable, fluid-operated, inflatable device, comprising: A fluid control system configured to control the flow of fluid between a fluid reservoir and an inflatable member, the fluid control system comprising: At least one fluid channel, said at least one fluid channel being defined within the housing; and At least one fluid component, positioned within the at least one fluid channel and configured to control the flow of fluid through the at least one fluid channel, the at least one fluid component comprising: Fluid chamber; A seal, positioned between the at least one fluid channel and the fluid chamber, and configured to seal the interface between the at least one fluid channel and the fluid chamber in a closed position of the at least one fluid component; and A seal retention mechanism is configured to retain the position of the seal in the open position of the at least one fluid component.

12. The implantable fluid-operated inflatable device according to claim 11, wherein, The seal includes an O-ring positioned in a groove in an opening in a substrate surrounding the at least one fluid component. and The seal retention mechanism includes: A textured layer formed on the surface of the groove; as well as A bonding layer is located between the textured layer and the O-ring, the bonding layer coupling the O-ring into the groove via the textured layer.

13. The implantable fluid-operated inflatable device according to claim 11, wherein, The seal is inserted into the substrate of the at least one fluid component, and the seal comprises: Main body; The flange portion located at the first end portion of the main body portion; The sealing portion located at the second end portion of the main body; and The opening formed in the main body portion, and The seal retention mechanism includes: An undercut portion, said undercut portion being formed in the main body portion of the substrate and configured to engage the flange portion of the seal; and A molding material is received through an opening in the body portion of the seal and is integrally formed between the body portion and the central opening of the substrate.

14. The implantable fluid-operated inflatable device according to claim 11, wherein, The sealing element includes: Main body; The flange portion located at the first end portion of the main body portion; The sealing portion located at the second end portion of the main body; and Extending from the first end portion to the second end portion of the main body portion through the opening of the main body portion, and The seal retention mechanism includes: An undercut portion, said undercut portion being formed in the main body portion of the substrate of the at least one fluid component, and configured to engage the upper portion of the flange portion of the seal; and A support plate is coupled to the bottom portion of the substrate and configured to engage the bottom portion of the flange portion of the seal, such that the flange portion of the seal is held between the substrate and the support plate.

15. The implantable fluid-operated inflatable device according to claim 11, wherein, The sealing element includes: Main body; The first flange portion is located at the first end portion of the main body portion; A second flange portion located at the second end portion of the main body portion, the second flange portion defining a sealing portion of the seal; and An opening extending through the first flange portion, the main body portion, and the second flange portion, and The seal retention mechanism includes: an undercut portion of the substrate of the at least one fluid component, wherein the undercut portion is positioned against an outer peripheral portion of the body portion of the seal and engages a first flange portion and a second flange portion of the seal to maintain the position of the seal relative to the substrate.

16. An implantable, fluid-operated, inflatable device, comprising: A fluid control system configured to control the flow of fluid between a fluid reservoir and an inflatable member, the fluid control system comprising: At least one fluid channel, said at least one fluid channel being defined within the housing; and At least one fluid component, positioned within the at least one fluid channel and configured to control the flow of fluid through the at least one fluid channel, the at least one fluid component comprising: Fluid chamber; A seal, positioned between the at least one fluid channel and the fluid chamber, and configured to seal the interface between the at least one fluid channel and the fluid chamber in a closed position of the at least one fluid component; and A seal retention mechanism is configured to retain the position of the seal in the open position of the at least one fluid component.

17. The implantable fluid-operated inflatable device according to claim 16, wherein, The at least one fluid component includes a valve device, the valve device comprising: substrate; An opening is formed in the substrate to connect the fluid chamber to the at least one fluid channel; A diaphragm, the diaphragm being coupled to the substrate, wherein the fluid chamber is defined between the substrate and the diaphragm; and A piezoelectric element, wherein the piezoelectric element is coupled to the diaphragm, wherein: In response to a first voltage applied to the piezoelectric element, the diaphragm is in a closed position relative to the substrate, wherein the seal seals the interface between the at least one fluid channel and the fluid chamber; and In response to a second voltage applied to the piezoelectric element, the diaphragm is deformed relative to the substrate to an open position to open the interface between the at least one fluid channel and the fluid chamber, and the seal retention mechanism holds the seal in position relative to the substrate.

18. The implantable fluid-operated inflatable device according to claim 17, wherein, The seal includes an O-ring positioned in a groove surrounding the opening formed in the substrate; and The seal retention mechanism includes: A textured layer formed on the surface of the groove; as well as A bonding layer is located between the textured layer and the O-ring, the bonding layer coupling the O-ring into the groove via the textured layer.

19. The implantable fluid-operated inflatable device according to claim 17, wherein, The seal includes an O-ring positioned in a groove surrounding the opening formed in the substrate; and The seal retention mechanism includes an undercut portion formed at an opening leading to the groove, wherein the size of the opening is smaller than the corresponding size of the O-ring, such that the O-ring is retained in the groove by the undercut portion.

20. The implantable fluid-operated inflatable device according to claim 17, wherein, The seal is an elastomeric O-ring, and wherein the seal retention mechanism includes a groove surrounding the opening formed in the substrate, the O-ring being received in the groove, wherein... The inner circumferential portion of the groove is larger than the corresponding size of the O-ring, such that the O-ring is held in the groove by the compressive force applied by the O-ring to the inner circumferential portion of the groove; or The outer periphery of the groove is smaller than the corresponding size of the O-ring, such that the O-ring is held in the groove by the tensile force applied by the O-ring to the outer periphery of the groove.

21. The implantable fluid-operated inflatable device according to claim 17, wherein, The seal is inserted into the substrate and molded into it. The seal includes: Main body; The flange portion located at the first end portion of the main body portion; The sealing portion located at the second end portion of the main body; and The opening formed in the main body portion, and The seal retention mechanism includes: An undercut portion, said undercut portion being formed in the main body portion of the substrate and configured to engage the flange portion of the seal; and A molding material is received through an opening in the body portion of the seal and is integrally formed between the body portion and the central opening of the substrate.

22. The implantable fluid-operated inflatable device according to claim 17, wherein, The sealing element includes: Main body; The flange portion located at the first end portion of the main body portion; A sealing portion located at the second end portion of the main body, the sealing portion extending through a corresponding opening in the substrate; and Extending from the first end portion to the second end portion of the main body portion through the opening of the main body portion, and The seal retention mechanism includes: An undercut portion, said undercut portion being formed in the main body portion of the substrate and configured to engage the upper portion of the flange portion of the seal; and A support plate is coupled to the bottom portion of the substrate and configured to engage the bottom portion of the flange portion of the seal, such that the flange portion of the seal is held between the substrate and the support plate.

23. The implantable fluid-operated inflatable device according to claim 17, wherein, The sealing element includes: Main body; The flange portion located at the first end portion of the main body portion; The sealing portion located at the second end portion of the main body; and Extending from the first end portion to the second end portion of the main body portion through the opening of the main body portion, and The seal retention mechanism includes: A recessed portion, the recessed portion being formed in the upper portion of the substrate and configured to receive the lower portion of the flange portion of the seal; and A support plate is coupled to an upper portion of the substrate and configured to engage an upper portion of a flange portion of the seal, such that the flange portion of the seal is held between the support plate and the substrate, wherein a sealing portion of the seal extends through an opening in the support plate.

24. The implantable fluid-operated inflatable device according to claim 17, wherein, The sealing element includes: Main body; The first flange portion is located at the first end portion of the main body portion; A second flange portion located at the second end portion of the main body portion, the second flange portion defining a sealing portion of the seal; and An opening extending through the first flange portion, the main body portion, and the second flange portion, and The sealing member retaining mechanism includes: an undercut portion of the main body portion of the substrate, the undercut portion being positioned to abut against the outer peripheral portion of the main body portion of the sealing member, and engaging the first flange portion and the second flange portion.

25. The implantable fluid-operated inflatable device according to claim 17, wherein, The sealing element includes: A first sealing portion, the first sealing portion being fixed to a stepped portion of the substrate, the stepped portion extending from the main body portion of the substrate into the at least one fluid channel; and The second sealing portion, which is fixed to the diaphragm, wherein... In the closed position of the diaphragm relative to the substrate, the second sealing portion is positioned against the first sealing portion of the seal to block the opening formed in the first sealing portion and close the at least one fluid passage; and In the open position of the diaphragm relative to the substrate, the second sealing portion of the seal is spaced apart from the first sealing portion, thereby opening the opening formed in the first sealing portion and opening the at least one fluid channel.

26. A fluid control system for an implantable, fluid-operated, inflatable device, comprising: At least one fluid channel is defined within the housing; as well as A fluid control device, positioned in the at least one fluid channel, comprising: substrate; A diaphragm is coupled to the substrate; A fluid chamber defined between the substrate and the diaphragm; An opening is formed in the substrate, the opening connecting the fluid chamber to the fluid passage of the fluid control device; A seal, disposed at the opening and configured to form a seal between the fluid passage and the fluid chamber when the fluid control device is closed; and A seal retention mechanism engages with the seal and is configured to retain the position of the seal in the open state of the fluid control device.

27. The fluid control system according to claim 26, wherein, The seal includes: an O-ring positioned in a groove surrounding the opening formed in the substrate; and The seal retention mechanism includes: The textured layer formed on the surface of the groove; and A bonding layer is located between the textured layer and the O-ring, the bonding layer coupling the O-ring into the groove via the textured layer.

28. The fluid control system according to claim 26, wherein, The seal includes: an elastomeric O-ring received in a groove surrounding the opening formed in the substrate; and The seal retention mechanism includes an undercut portion formed at an opening leading to the groove, wherein the size of the opening is smaller than the corresponding size of the elastomeric O-ring, such that the elastomeric O-ring is retained in the groove by the undercut portion.

29. The fluid control system according to claim 26, wherein, The seal is an elastomeric O-ring, and wherein the seal retention mechanism includes a groove surrounding the opening formed in the substrate, in which the elastomeric O-ring is received, wherein... The inner circumferential portion of the groove is larger than the corresponding size of the O-ring, such that the O-ring is held in the groove by the compressive force applied by the O-ring to the inner circumferential portion of the groove; or The outer periphery of the groove is smaller than the corresponding size of the O-ring, such that the O-ring is held in the groove by the tensile force applied by the O-ring to the outer periphery of the groove.

30. The fluid control system according to claim 26, wherein, The seal is inserted into the substrate and molded into it. The seal includes: Main body; The flange portion located at the first end portion of the main body portion; The sealing portion located at the second end portion of the main body; and The opening formed in the main body portion, and The seal retention mechanism includes: An undercut portion, said undercut portion being formed in the main body portion of the substrate and configured to engage the flange portion of the seal; and A molding material is received through an opening in the body portion of the seal and is integrally formed between the body portion and the central opening of the substrate.

31. The fluid control system according to claim 26, wherein, The sealing element includes: Main body; The flange portion located at the first end portion of the main body portion; A sealing portion located at the second end portion of the main body, the sealing portion extending through a corresponding opening in the substrate; and Extending from the first end portion to the second end portion of the main body portion through the opening of the main body portion, and The seal retention mechanism includes: An undercut portion, said undercut portion being formed in the main body portion of the substrate and configured to engage the upper portion of the flange portion of the seal; and A support plate is coupled to the bottom portion of the substrate and configured to engage the bottom portion of the flange portion of the seal, such that the flange portion of the seal is held between the substrate and the support plate.

32. The fluid control system according to claim 26, wherein, The sealing element includes: Main body; The flange portion located at the first end portion of the main body portion; The sealing portion located at the second end portion of the main body; and Extending from the first end portion to the second end portion of the main body portion through the opening of the main body portion, and The seal retention mechanism includes: A recessed portion, the recessed portion being formed in the upper portion of the substrate and configured to receive the lower portion of the flange portion of the seal; and A support plate is coupled to an upper portion of the substrate and configured to engage an upper portion of a flange portion of the seal, such that the flange portion of the seal is held between the support plate and the substrate, wherein a sealing portion of the seal extends through an opening in the support plate.

33. The fluid control system according to claim 26, wherein, The sealing element includes: Main body; The first flange portion is located at the first end portion of the main body portion; A second flange portion located at the second end portion of the main body portion, the second flange portion defining a sealing portion of the seal; and An opening extending through the first flange portion, the main body portion, and the second flange portion, and The sealing member retaining mechanism includes: an undercut portion of the main body portion of the substrate, the undercut portion being positioned to abut against the outer peripheral portion of the main body portion of the sealing member, and engaging the first flange portion and the second flange portion.

34. The fluid control system according to claim 26, wherein, The sealing element includes: A first sealing portion, the first sealing portion being fixed to a stepped portion of the substrate, the stepped portion extending from the main body portion of the substrate into the at least one fluid channel; and The second sealing portion, which is fixed to the diaphragm, wherein... In the closed state of the diaphragm relative to the substrate, the second sealing portion is positioned against the first sealing portion of the seal to block the opening formed in the first sealing portion and close the at least one fluid passage; and In the open state of the diaphragm relative to the substrate, the second sealing portion of the seal is spaced apart from the first sealing portion, thereby opening the opening formed in the first sealing portion and opening the at least one fluid channel.

35. The fluid control system according to claim 26, wherein, The fluid control device is one of a valve device, a pump device, or a combination of a pump and a valve device.

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