Systems and methods for valve control

Abstract

A system is disclosed that includes a flow control component. This system can include flow regulation and diversion systems for various purposes. The flow control component can be controlled according to selected parameters and methods.

Description

[0001] Cross-references to related applications

[0002] This application includes subject matter similar to that disclosed in concurrently filed U.S. Patent Application No. 16 / 944,466 (Attorney’s File No. 5074PS-000056). The entire disclosure of the aforementioned application is incorporated herein by reference. Technical Field

[0003] This disclosure relates to a valve assembly, and more particularly to a valve assembly and a method for using the valve assembly. Background Technology

[0004] This section provides background information in connection with this disclosure, which is not necessarily prior art.

[0005] The system can be used to treat selected or various conditions in subjects. It can treat subjects, such as human subjects, with hydrocephalus. Hydrocephalus can be caused by excessive production, insufficient absorption, or obstructed outflow of cerebrospinal fluid (CSF) from the ventricles of the brain. Therefore, hydrocephalus can cause a variety of symptoms in subjects. It may be desirable to treat hydrocephalus with a shunt system to allow CSF to be drained from the ventricles to different areas of the subject to treat or alleviate undesirable symptoms. Summary of the Invention

[0006] This section provides a general overview of the disclosure and is not a full disclosure of the complete scope or all features of the disclosure.

[0007] A shunt system can be implanted into a subject as a treatment for hydrocephalus. The shunt system may include an inlet and an outlet to shunt or guide fluid away from a first region of the subject to a second region. In various embodiments, the inlet catheter may be implanted into the ventricle of the subject and the outlet catheter may be positioned in a distal region, such as the subject's peritoneum and / or vascular system. The shunt system may further include a flow control system.

[0008] The flow control system may include a valve assembly. The valve assembly may have an opening or releasing pressure that allows fluid to flow through the valve system at a selected pressure. The valve system may include a valve seat and a selection mechanism for selecting or controlling the opening pressure of the valve body.

[0009] The flow control assembly may include various components, such as microelectromechanical systems (MEMS) for operation on the valve body and seat. The MEMS system can be controlled by various control components within the flow control assembly. Therefore, the flow control assembly can be a valve assembly mechanically operated by a MEMS system.

[0010] Furthermore, the control system may include one or more processors and selected memory, which can operate or control the MEMS system. Therefore, valve flow control can be controllable, such as autonomous or semi-autonomous control. Additionally, one or more feedback loops (which can be open or closed feedback loops) can be used to assist in controlling the valve assembly. Therefore, the flow control assembly may include one or more valve sections that can be used to control the valve assembly to operate the flow distribution system.

[0011] Further areas of applicability will become apparent from the description provided herein. The descriptions and specific examples in this overview are intended for illustrative purposes only and are not intended to limit the scope of this disclosure. Attached Figure Description

[0012] The accompanying drawings described herein are for illustrative purposes only, representing selected embodiments and not all possible specific implementations, and are not intended to limit the scope of this disclosure.

[0013] Figure 1 This is a schematic diagram of the shunt and system environment located within the subject's body according to various implementation schemes;

[0014] Figure 2 This is an exploded view of the valve assembly according to various implementation schemes;

[0015] Figure 3 It is along Figure 2 A cross-sectional view taken from line 3-3;

[0016] Figure 4 These are detailed views of the actuators according to various implementation schemes;

[0017] Figure 5A It is a top view of the supporting components;

[0018] Figure 5B It is along Figure 5A A cross-sectional view taken from line 5B-5B;

[0019] Figure 6 These are schematic diagrams of valve assemblies according to various implementation schemes; and

[0020] Figure 7 It is a flowchart of the operation of the valve assembly according to various implementation schemes.

[0021] In several views of all the accompanying drawings, the corresponding reference numerals indicate the corresponding parts. Detailed Implementation

[0022] Exemplary embodiments will now be described more fully with reference to the accompanying drawings.

[0023] Figure 1 The illustration includes a fluid guiding or shunt system 10. The shunt system 10 may be positioned or implanted in a subject 14, such as a human subject. The shunt system 10 may shunt or guide fluid flow along the shunt system 10, such as in the direction of arrow 18. The shunt system 10 may include a catheter 20, which may be an inlet catheter positioned within the ventricle 24 of the subject 14. As commonly understood by those skilled in the art, the inlet catheter 20 may be positioned (i.e. implanted) in the ventricle 24 to allow drainage of fluid away from the ventricle 24. The shunt system 10 may further include a selected flow control system 28 and an outlet catheter 32.

[0024] The selected flow control system 28 can be implanted in a suitable location within the subject 14. In various embodiments, the selected flow control system 28 can typically be implanted near the skull 36, torso 38, or any other suitable location of the subject 14. It should be understood that the inlet catheter 20 can be connected to the selected flow control system 28, as can the outlet catheter 32.

[0025] The outlet catheter 32 can extend from the selected flow control system 28 to a selected location, such as the peritoneal cavity in the trunk 38 of the subject 14. The inlet catheter 20, the selected flow control system 28, and the outlet catheter 32 can generally be understood as the shunt system 10. The shunt system 10 can be used as a hydrocephalus shunt system. The shunt system 10 can be implanted entirely within the subject 14.

[0026] Fluid can flow in the direction of arrow 18 and through inlet catheter 20, through a selected flow control system 28, and through outlet catheter 32. The fluid can then be drained or passed through outlet catheter 32 into the peritoneal cavity of subject 14 or any other suitable location. The fluid can be cerebrospinal fluid (CSF) generated in ventricle 24. Shunt system 10 can be implanted to aid in the treatment of hydrocephalus in subject 14. It should be understood that outlet catheter 32 can be positioned appropriately within subject 14 to allow CSF to be drained from ventricle 24 to appropriate locations, such as locations with high blood flow. Thus, as Figure 3 As shown, the inlet catheter 20, the selected flow control system 28, and the outlet catheter 32 can be implanted or positioned in the subject 14 as a CSF shunt system.

[0027] As described above, the flow splitter assembly 10 may include a flow control assembly 28. In various embodiments, the flow control assembly may include a valve assembly 50. (See reference...) Figure 2 and Figure 3The diagram illustrates valve assembly 50. Valve assembly 50 may be incorporated into flow control assembly 28, including other parts therein such as inlet and outlet caps, filters, etc., or may be included as the sole part of flow control assembly 28. Therefore, valve assembly 50 can be understood as the flow control assembly or system 28 as described above, or at least a portion thereof.

[0028] Therefore, according to various embodiments, valve assembly 50 may be provided as a flow control component 28 for controlling the flow through diversion component 10. In various embodiments, valve assembly 50 may include portions further discussed herein and may operate as also discussed herein.

[0029] Valve assembly 50 may typically include various portions, such as a first valve body or housing 54, which may also be referred to as a cover. Valve body 54 may include a cover or other removable portion relative to additional portions, such as a base or lower housing or body portion 58. Cover 54 may include one or more portions, such as a seat or sealing region 62 forming or defining a sealing surface 64. Sealing surface 64 may be engaged by a sealing member (such as a ball 68). The ball or sealing member 68 may include an outer surface 72 formed to mate with the sealing surface or ring 64. Thus, valve assembly 50 may seal the sealing member 68 into sealing surface 64 to stop flow through valve assembly 50.

[0030] Valve assembly 50 may include an inlet 20 that engages or seals at a sealing region 62 to an inlet portion or region 76. As described above, inlet 20 allows fluid to flow from ventricle 24 into inlet region 76 of valve assembly 50 generally in the direction of arrow 18. When valve member 68 is not sealed to sealing surface 64, fluid can flow through and across valve sealing region 62, through valve volume 78, and out outlet 82. Valve volume 78 is a reservoir volume of valve assembly 50. Outlet 82 may be integrally formed and / or connected to outlet conduit 32 such that fluid can flow through outlet conduit 32 generally in the direction of arrow 18, as described above. Thus, valve assembly 50 allows CSF to flow through valve volume 78 and / or stops flow by sealing member 68 to sealing surface 64, as discussed above and further herein.

[0031] Valve assembly 50 may include a valve body 54 and / or valve body portions 54, 58 forming a sealing configuration, such that the internal volume 78 of valve assembly 50 allows control of flow through valve assembly 50. The valve assembly may further adjust or vary the pressure of sealing member 68 against sealing surface 64. Thus, in various embodiments, sealing member 68 may be biased into sealing surface 64 generally in the direction of arrow 86. The pressure applied through inlet region or volume 76 may be generally in the direction of arrow 88, opposite to arrow 86. Sealing member 68 may be removed or displaced from sealing surface 64 to allow flow through outlet 82. As further discussed herein, the bias pressure or sealing pressure or force generally in the direction of arrow 86 may be adjusted and / or selected based on various factors and parameters to select the opening or release pressure to allow CFS to flow through valve assembly 50 generally in the direction of arrow 18.

[0032] Valve assembly 50 further includes a power source 94, which may include one or more batteries. Power source 94 may store electrical energy for operating or supplying power to the control assembly or portion 98. Control assembly 98 may include various portions for controlling or manipulating sealing member 68 relative to sealing portion or ring 64, such as those discussed further herein. In various embodiments, control assembly 98 may be sealed relative to valve volume 68 by a sealing assembly or internal sealing assembly 102. Sealing assembly 102 may include various portions, such as an external sealing ring or member 106, which may sit or seal against a wall 110 having an upper surface 114 that may seal against a lower surface 118 of control assembly portion 98. Internal sealing portion 102 may further include a sealing membrane 126 that may extend across a region within sealing member or portion 106. Sealing portion 106 may further include an upper surface 128 that may seal against an inner surface or lower surface 134 of valve body or cover 54. Therefore, valve volume 78 can be sealed relative to control assembly 98 and / or battery 94. Valve assembly 50 can operate on or include electronic components in control assembly 98, regardless of the material flowing through valve volume 78.

[0033] As described above, the control component portion 98 may include a sealing or engaging wall 114. The sealing wall 114 may extend from a selected component or surface, such as a printed circuit board (PCB) including a glass PCB 140. The PCB 140 may include selected components and / or include or encapsulate selected components, such as a coil or antenna assembly 144. The antenna assembly 144 can be used for various purposes, such as with an external controller or programmer 148. Figure 1Communication. Furthermore, antenna assembly 144 can be used to assist in recharging power supply 94 (e.g., inductive charging), such as using a near-field charging component end or an inductive component. Therefore, antenna 144 can be used to communicate with selected components (such as programmer 148) and / or for recharging power supply 94.

[0034] Antenna assembly 144 can be used for communication with control assembly 98 and / or with controller or programmer 148. Control assembly 98 may include various components for storing and / or executing instructions. For example, control assembly 98 may include various components for operating valve assembly 50 to control flow through diversion assembly 10.

[0035] For example, control component 98 may include a processing unit or module 150 that can communicate with a selected component (such as a microelectromechanical system (MEMS) 154) to control various parts on that selected component to operate valve assembly 50. A controller may be operable to move sealing member 68 into sealing ring 64. Control component 98 may further include a memory portion, such as being included with and / or separate from processor 150. Additionally, control component 98 may include various components, such as a signal generator 158, which can generate signals, such as those transmitted via antenna 144. Furthermore, control component 98 may include capacitors and / or other electronic components 162 and an oscillator assembly 166.

[0036] Various components of the control assembly 98 may be provided for the operation or assembly of the valve assembly 50, as discussed further herein. Typically, the control assembly 98 may include one or more processor systems that can receive feedback and / or instructions for selecting or providing opening or dispensing pressure to the sealing member 68 from the sealing ring 64. Thus, a processor 150 may be provided to execute selected instructions from various other suitable or selected electronic components to operate the valve assembly 50. Therefore, the components described above and herein may be exemplary, and alternative and / or additional components may be provided to operate the valve assembly 50.

[0037] According to various implementations, MEMS 154 may include one or more components to selectively control valve assembly 50, such as by applying a bias pressure or force generally in the direction of arrow 86 on the sealing member 68 to the sealing ring 64. (Continue to reference) Figure 2 and Figure 3 And refer to other sources. Figure 4The MEMS component 154 may include one or more actuators 180 formed on a substrate 184. The substrate 184 and actuators 180 may be formed in any suitable manner, such as those commonly known in the art. Such actuators and manufacturing techniques may include those manufactured or developed by Sandia National Labs. Other examples include sensors that may also function as actuators, such as MEMS microphones, including the MP34DT05 and MP34DT06J microphones sold by STMicroelectronics.

[0038] like Figure 4 and Figure 5B As shown, the actuator 180 can be actuated in at least two positions, such as a flat or generally planar position and a raised or engaged position. In the raised position, the actuator may include an engaging or contact surface or portion 190 that may engage a cantilever or support member 194. The valve assembly 50 may include a selected number of cantilever members 194, such as four cantilever members 194 forming a cross shape, as... Figure 2 As shown. The cantilever 194 may be individually identified as 194a, 194b, 194c, and 194d. The support 194 may be connected (e.g., cantilevered) at one end to the sealing member 106. The sealing member 106 may be further supported within the valve assembly 50, while the arm 194 extends from the valve assembly to interact with a valve support or support member 198 configured to support or retain the sealing member 68. The valve support 198 and / or the valve member 68 may otherwise be unsupported within the valve assembly 50. The flexible component 126 may provide some support, but the arm 194 may also help support the flexible component 126. However, it should be understood that the arm 194 does not need to cantilever from the sealing member 106 and may otherwise be supported from the base plate 184, the control assembly wall 110, or other suitable locations.

[0039] Therefore, in various embodiments, each cantilever portion 194 may be engaged by one or more actuators of actuators 180, such as engaging with contact portion 190. As discussed above and herein, each actuator may also be individually identified by a lowercase letter a, b, c, or d. Thus, a selected actuator may engage a selected support arm 194 to apply pressure to the valve support or support member 198 that supports or retains the sealing member 68 and / or directly to the sealing member 68.

[0040] Support member 198 can support sealing member 60 in a selected position relative to sealing ring 64. Support member 198 may include an outer wall 202 that forms or defines an inner surface 206, which may be complementary to or approximate the shape of sealing member 68. Since sealing surface 64 can also be complementary to or engage sealing member 68, support member 198 can also engage sealing member 68 to seal passageway or volume 78 relative to the flow of fluid through valve assembly 50. Thus, support member 198 can engage sealing member 60 and hold it in a selected position, and apply force generally in the direction of arrow 86 to select or control the flow of fluid through valve assembly 50.

[0041] Cantilever 194 may extend from sealing ring or wall 106 toward support member 198. Therefore, cantilever 194 may hold or support support member 198 relative to sealing wall 106 and / or control assembly wall 110. Figure 3 As shown, the valve assembly 50, including the control component 98 and the sealing component 102, can engage or seal the sealing member 68 within the valve assembly 50 and various control components of the control component 98, as discussed above.

[0042] Furthermore, the sealing or flexible component 126 may extend between the cantilever 194. As described above, the flexible component 126 may seal the valve volume 78 to isolate it from the control component 98. In addition, the flexible portion 126 may move together with the cantilever 194 to maintain the seal of the volume 78 relative to the electronic component 98 and other parts of the valve assembly, such as relative to the external sealing ring or wall 106.

[0043] In various embodiments, for example, actuator 180 may move cantilever 194 generally in the direction of arrow 86. In other words, actuator component 180 may move sealing member 68 to engage sealing surface 64. However, in various other embodiments, sealing member 68 may be assembled into valve assembly 50 such that sealing member contacts sealing surface 64. Actuator 180 may apply a force to increase the bias pressure of sealing member 68 on sealing surface 64, such as a force generally in the opening direction 88 that needs to be increased to be higher than or greater than the force generated by cantilever 194. Thus, actuator 180 may be operated or moved to an actuated or contact position to change or modify the opening pressure or force on valve assembly, such as moving sealing member 68 generally in the direction of arrow 88 to open valve assembly 50. Thus, actuator 180 may be operated to move sealing member 68 into sealing surface 64 and / or increase bias pressure generally in the direction of arrow 86 to adjust the opening or opening pressure of valve assembly 50.

[0044] Therefore, as shown, actuator 180 is typically movable or operable by selected electromechanical systems (including portions generally understood by those skilled in the art) to move in the direction of arrow 86 and / or arrow 88. For example, power supply or drive unit 220 may be formed or placed on electronic component 98. Drive unit 220 may be interconnected with various linkages, such as a first linkage 224 to one or more gears or gear assemblies 228. Gear assembly 228 may rotate when powered by drive 220. Gear assembly 228 may transmit, increase or decrease the power ratio, or change the direction of the motor force. Motor force may move drive or push arm 232, which may be held or moved relative to rail or rail assembly 236.

[0045] The drive arm 232 can be hingedly connected to a first member or support member 244 of the actuator 180 via one or more hinges 240. The first support member 244 can be hingedly connected to a second support member 252 via a second hinge portion or assembly 248. The two support members 244, 252 can interact to form the actuator 180, as further discussed herein. The second support member 252 can also be hingedly connected to the base plate 184 via a third hinge portion or assembly 256.

[0046] As will be understood by those skilled in the art, actuator assembly 180 can be formed on substrate 184 in any suitable manner. For example, a MEMS system or machine such as actuator 180 can be formed by selected suitable techniques such as etching (e.g., wet or dry etching), electrical discharge machining (EDM), molding, plating, etc. As will be understood by those skilled in the art, various manufacturing techniques can be used to form various components of a MEMS system, such as actuator 180. Actuator 180 can then be incorporated into and / or combined with other components, such as with processor 150, to operate according to selected techniques and / or instructions.

[0047] Continue to refer to Figure 3 and Figure 4 And refer to other Figure 5A and Figure 5B Actuator 180 can be operated, for example, according to instructions executed by processor 150, to engage one or more of the cantilever or support arm 194. Actuator 180 can be moved to an actuated or engaged position, such as... Figure 4 As shown. In the engaged position, the engaging portion 190 may engage or contact the support member or cantilever 194. Figure 4As shown, according to various embodiments, the engagement portion 190 may be supported by a second engagement or support member 252 relative to or against a first support member 244. The first support member 244 may be moved to push against the second support member 252, and thus cause the second support member to move generally vertically, such as generally away from the substrate 184 in the direction of arrow 86. During movement or in the engagement position, the actuator 180 may engage the cantilever 194.

[0048] Reference Figure 5A and Figure 5B The base plate 184 may be positioned relative to or near the support structure or portion 102. In various embodiments, for example, two support cantilever members 194a, 194c may extend externally or toward the valve support member 198 extending wall 106. The support members 194a, 194c may generally be formed to be substantially rigid and support the support member 198 at a selected distance from the outer wall 106. Typically, any one of the support arms 194a, 194c, or support arm 194 may have substantially the same length 260 from the inner wall 106 to the support member 198 and / or to the center of the support member 198.

[0049] When the sealing member 68 is positioned within the support member 198 and engages the sealing surface 64, an input force, such as in the direction of arrow 88, can deflect or move the sealing member 68 away from the sealing surface 64 by also deflecting or moving the support member 194 in the direction of arrow 88. Therefore, the force applied by the support member 194 can be overcome by an input force (such as hydraulic pressure caused by the inflow of fluid). Furthermore, the opening force can be set by the distance 260, the form or material of the support member 194, or other suitable characteristics. For example, size, thickness, stiffness, material selection, etc., can be used to set or select the initial force required to move the sealing member 68 away from the sealing surface 64.

[0050] However, during operation of the flow control valve assembly 50, the actuator 180 can be selectively operated to engage the support member 194. In various embodiments, multiple actuators may be provided. In various embodiments, for example, three actuators may be positioned between or within a distance 260. For example, as... Figure 5AAs shown, there may be three actuators among actuators 1801, 1802, and 1803 between the substrate 184 and the support member 194a. Additionally, there may be three additional actuators 1804, 1805, and 1806 between the substrate 184 and the support member 194c. During operation, any one or more of the actuators 180 can be actuated to contact the corresponding support member 194. Furthermore, in various manufacturing techniques, each actuator can be individually and separately operated or actuated to contact the support member 194. It should be understood that supports 194b and 194d also include corresponding actuators 180, which are not specifically discussed here, but should be understood to operate in a substantially similar manner.

[0051] During operation of valve assembly 50, for example, the outermost or first actuator for the two support arms 194a, 194c can be operated. Thus, actuators 1801 and 1806 can be operated to extend from base plate 184 and contact the respective support members 194a, 194c. Figure 4 As shown, actuator 180 may extend from the substrate and contact area 190 may contact support member 194. Therefore, support member 194 may be further reinforced or have an effectively shortened distance 260, such as shortened to distance 260'. By reinforcing support member 194 and / or further supporting support member 194 relative to substrate 184, the force required to move sealing member 68 in the direction of arrow 88 or to remove sealing member 68 from sealing surface 64 can be increased. The amount of force may generally be known and calibrated relative to or according to distance 260 and / or distance 260, a selected number of actuators 180 actuated to engage the respective support member 194, or other suitable mechanisms. Therefore, actuation of actuator 180 to contact support member 194 can be performed and the opening pressure of valve assembly 50 can be increased.

[0052] According to various implementations, for example, valve assembly 50 can be operated to select an opening pressure or force that causes sealing member 68 to open. Selective feedback can be provided to select the opening pressure. The opening pressure can be selected or set. Furthermore, the opening pressure or force can be based on a selected or measured input pressure.

[0053] As discussed above, various actuators 180 are described according to various embodiments and are exemplary illustrations of actuators that can be formed as “A” frame sub-assemblies. These actuators may contact the support member 194 to generate or allow the sealing member 68 to remain seated in or against the sealing surface 64 and / or move away from the sealing surface 64.

[0054] like Figure 2 and Figure 3As shown, valve assembly 50 may further include pressure sensor assembly 290. Pressure sensor 290 may be incorporated into support member 198, such as being included together with support member 198, to engage or sense pressure on support member 198. Pressure sensor 290 may also be another suitable component. In various embodiments, pressure sensor 290 may include or be incorporated into sealing diaphragm 126 and / or support member 194. For example, pressure sensor 290 may be any suitable pressure sensor, such as a piezoresistive pressure sensor, and sealing portion or member 126 may serve as its component. Suitable piezoresistive pressure sensors include pressure transducers, such as those sold by Koninklijke Philips NV with U.S. Commercial Speed, including and / or similar to the pressure sensor included in the CPJ84022 pressure transducer assembly sold by Koninklijke Philips NV. Other examples include the MPX5010 / MPXV5010G / MP3V5010 series sensors sold by NXP Semiconductors. Pressure sensor 290 senses the pressure of sealing member 68 against valve seal 198. The pressure sensed by pressure sensor 290 can be based on input pressure such as through inlet 20. Therefore, the pressure through inlet 20 can be based on the pressure flowing into inlet 20 and / or into valve assembly 50 at CFS. Pressure sensor 290 can transmit the signal to processor 150 in an appropriate manner, such as by wired connection (e.g., via traces from support assembly 102 to electronic assembly 98), wirelessly, or a combination thereof. This signal can be measured over time and can therefore be measured as absolute instantaneous pressure, pressure change, or other appropriate determination of the pressure sensed at pressure sensor 290.

[0055] Valve assembly 50 can be operated based on signals from pressure sensor 290. For example, valve assembly 50 can be operated using selected pressure threshold changes, selected measurements of absolute or instantaneous pressure, or any other suitable pressure determination. As further discussed herein, for example, at a selected instantaneous pressure (e.g., pressure above a selected threshold), a number of actuators 180 can be relaxed or rendered inactive to allow CSF to flow more easily through valve assembly 50 (e.g., by reducing the opening force). Furthermore, at a selected instantaneous pressure (e.g., pressure below a selected threshold), a selected number of actuators 180 can be operated to increase the opening pressure required to move sealing member 68 from sealing surface 64. Thus, a selected CSF volume or pressure can be maintained within the ventricle 24 of subject 14 based on selected parameters, such as those identified and programmed by the user (e.g., with programmer 148).

[0056] As described above, valve assembly 50 may include various components, including those positioned and discussed above. Referring again to the above figures and further to… Figure 6 Valve assembly 50 may include various operable components, as discussed further herein. Typically, valve assembly 50 may include a processor or control assembly 150. As described above, the processor module or control module can be used to evaluate various inputs to control the operation of the components of valve assembly 50. Inputs may also be various types of inputs, such as sensor inputs or external inputs.

[0057] In various embodiments, the programmer 148 can be operated by a user (such as a clinician or surgeon) to select a setpoint or selected value for one or more parameters of the valve assembly 50 or relating to the valve assembly. In various embodiments, the setpoint can be a pressure setpoint, such as the pressure experienced at or on the valve member at the inlet, sealing area, or seat 62. The selected setpoint can be one or more discrete pressure setpoints, which can be directly selected by the user and / or selected from a list. As described above, the programmer 148 can include various inputs or input portions, such as buttons or a touchscreen 149 and / or a display 151. Therefore, the user can provide various inputs and / or selections to the programmer 148.

[0058] Then, the user's selection from programmer 148 can be transmitted to controller 150, such as... Figure 6 As shown. The transmission can be in any suitable manner, such as wireless, wired, or other types of transmission. As described above, valve assembly 50 may include one or more components, such as antenna 144. Therefore, programmer 148 can wirelessly transmit signals to controller 150 via antenna 144. In any case, programmer 148 can be used to determine or select setpoints, such as pressure setpoints for valve assembly 50. It should be understood that other suitable inputs can be provided to controller 150 to select or determine setpoints, such as pressure setpoints.

[0059] As described above, valve assembly 50 may include pressure sensor 290, which may be incorporated into or located in selected portions of valve assembly 50, such as within or near reservoir 78. Pressure sensor 290 may measure pressure within reservoir 78 or other selected portions of valve assembly 50. Pressure sensor may then transmit a signal to controller 150. As described above, the signal may be transmitted wirelessly and / or via electronics of valve assembly 50. However, pressure sensor 290 may measure or sense pressure and transmit selected signals associated with the measured pressure to controller 150.

[0060] The controller 150 may further include an integrator, which may be included in the processor module, to integrate the setpoint input or compare it with a measured pressure input. The controller 150 then integrates the received measured pressure input or compares it with the setpoint pressure input. Based on this comparison, the controller 150 can then determine to change or modify the configuration of the valve assembly 50. As described above, the valve assembly 50 can be operated to increase or decrease the opening or closing pressure of the valve components, thereby increasing or decreasing the flow rate through the valve assembly. Therefore, if determined based on the comparison, the controller can transmit a signal (also referred to as an actuator signal) to the actuator 180.

[0061] Upon receiving a selected signal from the controller 150, the actuator 180 can then be activated or deactivated (e.g., moved to an inactive position), or remain in the same position. As described above, the actuator 180 can be activated or raised (i.e., Figure 4 The actuator 180 can be used to change or increase the opening or opening pressure of valve assembly 50. When raised, the actuator contacts support arm 194. The actuator 180 can be deactivated or lowered to reduce the opening or opening pressure of valve assembly 50. When lowered, the actuator contacts support arm 194. Therefore, the actuator 180 can operate or move based on a signal from controller 150, taking into account the pressure measured or sensed from pressure sensor 290.

[0062] Valve components (such as valve member 68, sealing region 64, and / or ball or valve support 198) can then be altered or implemented by actuator 180, as discussed above. Actuator 180 can increase or decrease the effective length of support 194 to change the force (e.g., bias) on valve seat 198. Thus, the valve can change its configuration and the opening pressure for operating valve assembly 50.

[0063] According to various implementation schemes, valve assembly 50 may include, for example: Figure 6 The components shown are for administering therapy to subject 14. A user can select a pressure setpoint, such as via programmer 148, which is transmitted to controller 150. Controller 150 can then receive input from the setpoint and measure or sense pressure from pressure sensor 290 for operation of valve assembly 50.

[0064] In various embodiments, the setpoint may include a selected number of discrete pressure settings, such as settings between about 20 mm of water (about 0.02 psi) and about 400 mm of water (about 0.6 PSI), or about 20 discrete pressure settings at selected intervals. In various embodiments, for example, the discrete pressure settings may be about 20 mm of water, or between 20 mm and 400 mm of water. The user can select from the selected number of discrete settings using programmer 148, which can be displayed on display 150. However, it should also be understood that the selected setpoint can be made by the user and then transmitted to controller 150 for operation and control of valve assembly 50.

[0065] Continue to refer to Figure 6 And refer to other Figure 7 The flowchart 300 illustrates a method or operation of valve assembly 50. Method 300 may begin at start box 310. Start box 310 may include appropriate steps or portions, such as the activation operation of valve assembly 50. It should be understood that start box 310 may further include and / or proceed according to other operations, such as diagnosis of subject 14, determination of selected therapy, implantation of valve assembly 50, selection of various features, etc. However, process 300 may begin at start box 310. After start 310, valve assembly 50, such as controller 150, may receive input. As described above, programmer 148 or other suitable component may be used to select a signal and transmit that signal to valve assembly 50. Programmer 148 may be operated by a selected user to transmit input or signals to valve assembly 50.

[0066] The input received in block 320 can be any suitable input, such as a pressure input setpoint. As described above, a user can select one or more pressure setpoints, and these pressure setpoints can be received by controller 150. Other suitable inputs may also include a flow rate that can be realized or selected by valve assembly 50. Furthermore, a specific actuator configuration can be determined. As described above, actuator 180 can be used to select or realize a selected distance 260 of support 194. A specific configuration can be determined by the user and provided as an input that can be received by controller 150. However, as described above, the input can be a pressure setpoint, and controller 150 can select the actuator 180 to be activated based on a predetermined configuration (e.g., factory calibration). However, input can be received at controller 150 in block 320. In various embodiments, the input may also include a start or stop command for valve assembly 50.

[0067] In block 330, the input received at controller 150 can be used in combination with sensed or measured parameters. For example, the sensed or measured parameters in block 330 can be related to or relating to the input received from block 320. For example, as discussed above, pressure sensor 290 can sense pressure in reservoir 78, such as pressure at valve member 68 of valve assembly 50. The measured parameters may also include flow rate or other suitable measurements. In various embodiments, such as those discussed further herein, pressure is measured using pressure sensor 290 in block 330. Then, in block 340, the sensed or measured pressure can be transmitted along with a signal from pressure sensor 290. In block 350, the signal can be transmitted to controller 150 for comparison with the received input.

[0068] As discussed above, controller 150 may include various components, such as integrators, processor modules, etc., for comparing received inputs with transmitted signals. In various embodiments, the received input may include a pressure setpoint from programmer 148. The pressure setpoint can then be compared with a signal from a pressure sensor transmitted in block 340 and compared in block 350. This signal may include selected signals, such as analog or digital signals that can be compared with the input received from block 320. A suitable comparison can be any suitable comparison to allow determination of whether valve assembly 50 is operating at a selected setpoint. Therefore, controller 150 can then make a decision in block 360 as to whether the transmitted signal matches the received setpoint.

[0069] Decision box 360 can be made based on comparison box 350. Therefore, the selected user can transmit a setpoint in box 320, which can be compared with the parameter measured in box 330 in box 350.

[0070] If decision block 360 determines that the transmitted signal matches the received input, then the "yes" path 370 can be followed. The "yes" path 370 can return to receiving the input in block 320 and / or sensing the measured parameter in block 330. Therefore, in various embodiments, method 300 can be a loop process where parameters are continuously measured in block 320 and compared in block 350. Decision block 360 can then be used to determine whether the operation of valve assembly 50 needs to be changed. In block 320, periodic checks (such as over a selected time period, including hourly, every 24 hours, etc.) can be performed to determine whether controller 150 has received additional input from the user. Therefore, selected additional or new input from the user to controller 150 can modify or change the operation of method 300. For example, the user can determine to stop the operation of valve assembly 50, such as for maintenance, removal, etc.

[0071] If decision block 350 determines that the signal transmitted from block 340 does not match the input received from block 320, then a "No" path 380 may be followed. The "No" path 380 may include transmitting a signal to activate or deactivate an actuator in optional block 390. As discussed above, in block 400, the actuator can modify the valve assembly. Actuator 180 can modify or alter various valve components, such as the seal or member 126, support 190, etc. Transmitting a signal in block 390 to activate or deactivate the actuator may be a selected operation of valve assembly 50 to modify or alter valve assembly 50 in an attempt to achieve a selected setpoint or input from the user in block 320. Therefore, when following the "No" path 380, modifications to the valve assembly in block 400 may be performed. Appropriate modifications may include activating or deactivating one or more actuators, such as by transmitting a signal in block 390.

[0072] After modifying the valve assembly in box 400, parameters can continue to be sensed or measured in box 330, as discussed above when following the "Yes" path 370. Again, periodic or selected checks on user input can also be performed in box 320, such as within a selected or set time period.

[0073] Therefore, valve assembly 50 can be operated according to method 300 for controlling the pressure and / or flow rate through valve assembly 50. Valve assembly 50 may receive signals, such as at controller 150. This signal may come from a user, such as via programmer 148, to control or select the operation of valve assembly 50. As described above, this selection may include the selection of a pressure setpoint. Therefore, method 300 can be used to operate or control valve assembly 50, such as by operating or controlling the valve assembly with controller 150.

[0074] Exemplary embodiments are provided to make this disclosure thorough and to fully communicate the scope of this disclosure to those skilled in the art. Numerous specific details, such as examples of particular components, apparatus, and methods, are set forth to provide a thorough understanding of embodiments of this disclosure. It will be apparent to those skilled in the art that specific details are not required, that exemplary embodiments may be embodied in many different forms, and should not be construed as limiting the scope of this disclosure. In some exemplary embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

[0075] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which correspond to tangible media such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and is accessible by a computer).

[0076] The instructions can be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, graphics processing units (GPUs), application-specific integrated circuits (ASICs), field-programmable arrays (FPGAs), or other equivalent integrated or discrete logic circuit systems. Therefore, the term "processor" as used herein can refer to any of the foregoing structures or any other physical structures suitable for implementing the described techniques. Furthermore, this technique can be fully implemented in one or more circuit or logic elements.

[0077] The foregoing description of embodiments has been provided for illustrative and descriptive purposes. The foregoing description is not intended to be exhaustive or limiting of this disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable and may also be used in selected embodiments where applicable, even if not specifically shown or described. The same element or feature may be varied in many ways. Such variations should not be considered as departing from this disclosure, and all such modifications are intended to be included within the scope of this disclosure.

[0078] It should be understood that the various aspects disclosed herein can be combined in combinations different from those specifically given in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any process or method described herein may be performed in a different order, or may be completely added, combined, or omitted (e.g., performing the described technique may not require all the described actions or events). Furthermore, although for clarity some aspects of this disclosure are described as being performed by a single module or unit, it should be understood that the techniques of this disclosure can be performed by combinations of units or modules associated with, for example, a medical device.

Claims

1. A flow and / or pressure regulating component for a hydrocephalus shunt system, the regulating component comprising: Valve seat; A valve component configured to be supported relative to the valve seat to regulate the flow rate into the reservoir; An arm support member, wherein the arm support member is configured to bias the valve member into a closed position relative to the valve seat; A substrate, the substrate being located on the side of the arm support member away from the valve member; and An actuator, formed on the substrate, comprising: First supporting component; Second supporting component; Push arm; and Start the system; The first support member is hingedly connected to the second support member, the second support member is hingedly connected to the substrate at a fixed position, and the first support member is hingedly connected to the push arm, the push arm being configured to move the second support member; and The starting system is configured to move the second support member relative to the first support member to raise or lower the first support member; The effective support length of the arm support member determines the bias force on the valve member, and the actuator is selectively positioned in an active or inactive position to select the effective support length.

2. The component according to claim 1, further comprising: A valve support member configured to hold the valve member; The arm support member extends from the valve support member to the connection portion.

3. The component according to claim 1, further comprising: A pressure sensor is configured to sense the pressure within the reservoir and transmit a pressure signal associated with the sensed pressure to the controller.

4. The component of claim 3, wherein the controller is configured to execute instructions to compare the sensed pressure transmitted via the pressure signal with a predetermined setpoint pressure.

5. The component of claim 4, wherein the controller is configured to transmit an actuator signal to the actuator based on a comparison of the sensed pressure with the predetermined setpoint pressure, so as to move the actuator between the active position and the inactive position.

6. The component of claim 1, wherein the actuator is a microelectromechanical system (MEMS).

7. The assembly of claim 1, wherein the first support member is guided within the track assembly to direct force to the second support member.

8. The component of claim 1, wherein the actuator in the active position alters the effective length of the arm support member to increase the bias pressure on the valve member.

9. The component of claim 1, further comprising: An inlet conduit having a length between a first end and a second end, wherein the second end is connected to the reservoir inlet; and An outlet conduit is connected to the reservoir outlet.

10. The assembly of claim 1, wherein the arm support member is operable to have a plurality of effective support lengths.

11. The component of claim 1, comprising a plurality of the actuators and a plurality of the arm support members.

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