System and method for valve evaluation

Abstract

A system is disclosed that includes a flow control assembly. The system can include a flow adjustment valve assembly and associated sensors. Signals from the sensors can be used to provide information about the shunt assembly and its operation to an external system.

Description

Technical Field

[0001] This disclosure relates to a valve assembly, and more particularly to a valve assembly and a method associated with the valve assembly. Background Technology

[0002] This section provides background information in connection with this disclosure, which is not necessarily prior art.

[0003] 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 conditions 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 conditions. Summary of the Invention

[0004] This section provides a general overview of this disclosure and is not a full disclosure of the complete scope or all features of this disclosure.

[0005] A shunt system may be implanted in a subject as a treatment for hydrocephalus. The shunt system may include an inlet and an outlet for shunting or guiding 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 abdomen (e.g., lined with peritoneum) and / or vascular system). The shunt system may further include a flow control system. The shunt may be secured to the peritoneum or vascular system.

[0006] A flow control system may include a valve assembly. The valve assembly may have an opening or opening 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.

[0007] One or more sensors may be disposed relative to the valve. A first sensor may be disposed in a flow divider upstream of the valve, and one or more sensors may be disposed in a flow divider downstream of the valve. One or more sensors may be disposed in a reservoir of the valve. Furthermore, the valve assembly may include a valve cover or housing that includes one or more sensors upstream or downstream of the valve.

[0008] Sensors can be used to determine the pressure or flow rate at the sensor location. The sensor can then transmit a signal based on the sensed pressure or flow rate. This signal can be sent from the shunt assembly for further analysis. The analysis can be provided or used for various purposes, such as valve diagnostics, valve operating efficiency, etc.

[0009] 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

[0010] The accompanying drawings described herein are for illustrative purposes only, representing the selected embodiments and not all possible specific implementations, and are not intended to limit the scope of this disclosure.

[0011] Figure 1 This is a schematic diagram of the shunt and system environment located within the subject's body according to various implementation schemes;

[0012] Figure 2 It is a perspective view of the valve assembly according to various implementation schemes;

[0013] Figure 3 This is a top plan view of a modular valve assembly based on various implementation schemes;

[0014] Figure 4 This is a schematic diagram of a sensor reading and collection system based on various implementation schemes;

[0015] Figure 5 This is a schematic diagram of a sensor reading and collection system based on various implementation schemes;

[0016] Figure 6 These are schematic diagrams of sensor reading and collection systems according to various implementation schemes; and

[0017] Figure 7A and Figure 7B A flowchart illustrating the process for analyzing sensor data according to various implementation schemes is shown.

[0018] In several views of all the accompanying drawings, the corresponding reference numerals indicate the corresponding components. Detailed Implementation

[0019] Exemplary embodiments will now be described more fully with reference to the accompanying drawings.

[0020] Figure 1 The illustration includes a fluid guiding or shunt system 10. The shunt system 10 may be positioned or implanted within 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 (e.g., implanted) within 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.

[0021] The selected flow control system 28 may be positioned (e.g., implanted) in an appropriate location within the subject 14. In various embodiments, the selected flow control system 28 may typically be implanted near the skull 36, torso or abdomen 38, or any other suitable location of the subject 14. It should be understood that the inlet catheter 20 may be connected to the selected flow control system 28, as may the outlet catheter 32.

[0022] The outlet catheter 32 can extend from the selected flow control system 28 to a selected location, such as the peritoneal cavity in the abdomen 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 integrally into the subject 14.

[0023] Fluid may 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 may then be drained or passed through outlet catheter 32 into the abdomen or peritoneal cavity or any other suitable location of the subject 14. The fluid may be cerebrospinal fluid (CSF) generated in the ventricle 24. A shunt system 10 may be implanted to aid in the treatment of hydrocephalus in the subject 14. It should be understood that outlet catheter 32 may be positioned in a suitable location within the subject 14 to allow CSF to be drained from the ventricle 24 to a suitable location, such as a location with high blood flow. Thus, as... Figure 3 As illustrated, 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.

[0024] As discussed 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. Depending on the embodiment, the valve assembly may be located within various embodiments (such as one or more valve assemblies 50a, 50b). Reference Figure 2 and Figure 3 The diagram illustrates one or more valve assemblies 50a, 50b according to various embodiments. The valve assembly may be incorporated into the flow control assembly 28, including other parts therein such as inlet and outlet caps and filters, or may be included as the sole part of the flow control assembly 28. Therefore, the valve assembly can be understood as the flow control assembly or system 28 as discussed above, or at least a portion thereof.

[0025] Therefore, according to various embodiments, the valve assembly may be configured as a flow control component 28 for controlling the flow through the diversion assembly 10. In various embodiments, the valve assembly may include portions further discussed herein and may operate as also discussed herein.

[0026] For example, first refer to Figure 2 The diagram illustrates a valve assembly 50a according to various embodiments. Valve assembly 50a typically includes various portions, such as a first valve body or housing 54, which may also be referred to as a cap. Valve body 54 may include a cap or other removable portion relative to additional portions, such as a base or lower housing or body portion 58.

[0027] The inlet conduit 20 can be connected to the inlet connector or port 64 of the valve assembly 50. The connector 64 can be any suitable port or assembly configuration. For example, the connector 64 may include a barb portion 66 to allow the inlet conduit 20 to be pushed over and engaged with the connector 64, and to be at least liquid-sealed to the connector 64. The connector 64 may be formed of a substantially rigid material to allow a flexible material of the inlet conduit 20 to slide over the barb portion 66. Thus, a liquid-sealed connection can be formed with the valve assembly 50a. The valve assembly 50a may also include an outlet connector 70. The outlet connector 70 may also include a barb portion 72. The barb portion 72 may operate in a similar manner to the outlet conduit 32. The outlet conduit 32 may be formed of a compliant or flexible material that slides over the connector 70 to form a liquid seal with the connector 70, including with the connector.

[0028] Therefore, the inlet conduit 20 and the outlet conduit 32 can be liquid-sealed and connected to the valve assembly 50a. Conduits 24 and 32 can be interconnected with the valve assembly 50a at any appropriate time (such as after the various conduits are positioned, during the construction of the valve assembly 50a, or at any other appropriate time).

[0029] Valve assembly 50a also includes valve mechanism 76. The valve mechanism may be modular or integrated with the cap 54 or base 58 of valve assembly 50a. Valve mechanism 76 may be any suitable valve mechanism, such as one or more or a combination of those disclosed in U.S. Patent No. 11,701,503, published July 18, 2023, and U.S. Patent No. 10,369,335, published August 6, 2019, all of which are incorporated herein by reference. Furthermore, those skilled in the art will understand that appropriate or suitable combinations thereof may also be used as valve mechanism 76 in valve assembly 50a.

[0030] Valve mechanism 76 may be associated with a cylinder or retainer portion 78, which may interconnect with connector 70. According to various embodiments, connector 70 may be formed as a separate component and interconnected with valve mechanism 76 in any suitable manner. Furthermore, according to various embodiments, a fluid-tight connection may be formed between connector 70 and connector 78 or valve mechanism 76.

[0031] As discussed above, cover 54 may cover valve mechanism 76 and various connectors, such as cylindrical connector 78. Furthermore, cover 54 may be formed or attached to base 58.

[0032] Upstream of valve mechanism 76, and covered by housing or cap 54, may be a reservoir 82. Reservoir 82 may be provided to allow or supply a selected pressure or volume within valve assembly 50a. Reservoir 82 may collect fluid from the inlet side (such as at inlet connection 64). Reservoir 82 may be formed between cap or cap 54 and base 58.

[0033] Therefore, valve assembly 50a may include various portions to allow fluid to be delivered from or shunted from ventricle 24 to the abdomen or other parts of subject 14. Valve assembly 50a, including valve mechanism 76, can controllably or selectively control the flow rate of fluid. Thus, a selected flow rate through valve assembly 50a may be selectively maintained or desired. For example, the flow rate may be selected via adjustment of valve mechanism 76. The flow rate can be any suitable flow rate and may be specific to subject 14. However, it may be optional to maintain the selected flow rate and / or confirm that the shunt assembly 10 is not blocked, as discussed herein. Various sensors, such as pressure sensors, can provide signals that can be analyzed as discussed herein to help determine at least the probability of blockage.

[0034] Therefore, valve assembly 50a can also be monitored for various purposes. For example, monitoring or sensing the condition of various parts of valve assembly 50a can allow for determining whether the valve assembly should be changed, confirming the operation of the valve assembly (or its parts, such as valve mechanism 76), and determining other information.

[0035] Therefore, in various embodiments, the first sensor assembly 100 may be located at the inlet. Sensor assembly 100 can be any suitable sensor assembly that can be incorporated into valve assembly 50a. For example, sensor assembly 100 may be integrated and positioned in the inlet region, such as in connector 64 of valve assembly 50a. Furthermore, a second sensor assembly 104 may be integrated into valve assembly 50a. The second sensor assembly 104 may be similar to the first sensor assembly 100, except that it is positioned near the outlet, such as in outlet connector 70 of valve assembly 50a. Thus, the first or inlet sensor assembly 100 and the second or outlet sensor assembly 104 may be located in valve assembly 50a. Alternative or additional sensor assemblies may include sensor assembly 110, which is included in a reservoir or capable of sensing the condition of reservoir 82. Valve assembly 50a may include any suitable number of sensor assemblies, and the inlet sensor assembly 100, outlet sensor assembly 104, and reservoir sensor assembly 100 are merely exemplary.

[0036] In short, sensor assemblies 100 and 104 may be or include sensors of selected types or configurations, as discussed herein. A sensor assembly may include a sensor portion, a transmitting portion, a receiving portion, and / or a power supply. In various embodiments, the receiver portion may receive signals to activate sensing and generate signals for the sensor. The transmitter portion may transmit signals from the sensor. The sensor assembly may also include a memory or a processor. Each portion of the sensor assembly may be a module, as discussed herein. Each module may sense physical parameters and / or execute selected instructions. In various embodiments, the parameter being measured may be intracranial pressure (ICP) of subject 14. ICP may be selected for subject 14, and one or more sensors may sense current or real-time pressure and transmit signals regarding the measurement results.

[0037] Steering Reference Figure 3 Valve assembly 50b is illustrated. Valve assembly 50b may include those parts that are substantially similar to the parts of valve assembly 50a. Similar numbers will be used to identify those similar to those discussed above, but with an apostrophe added. For example, valve assembly 50b may include a housing or cover 54' and a base 58'. Valve assembly 50b may include a reservoir 82' and an inlet connector 64' and an outlet connector 70'. Valve assembly 50b may include a valve mechanism 76' similar to that discussed above to help connect or inspect the flow through valve assembly 50b or control the flow through the valve assembly. Furthermore, valve assembly 50b may include any of the parts discussed above with respect to valve assembly 50a, and vice versa. Valve assembly 50 may be configured according to various embodiments, and the parts discussed and illustrated in valve assemblies 50a and 50b are exemplary and may be mixed and matched.

[0038] Valve assembly 50b can be connected to one or more sensor assemblies, which can be connected to various portions of valve assembly 50b. For example, inlet sensor assembly 120 can be connected to inlet connector 64. The inlet connection sensor assembly may include valve connector 124, which can be connected directly or via pipe portion 126 to inlet connector 64. Inlet sensor assembly 120 may include sensor housing 130, which can accommodate sensor portion or assembly 134. Sensor assembly 134 may be similar to or the same as inlet sensor assembly 100 discussed above. Sensor assembly 120 may include conduit connector 136 for connection to inlet conduit 20. Thus, inlet sensor assembly 120 may be aligned with inlet 64' of valve assembly 50b.

[0039] The outlet sensor assembly 140 may be associated with the outlet portion of the sensor valve assembly 50b, such as with outlet 70'. The sensor assembly 140 may have an outlet connector 144 that can be directly connected to outlet connector 70' or connected to it via a pipe portion 148 similar to the pipe portion 126 discussed above. Therefore, the outlet sensor assembly 140 may be associated with the outlet of the valve assembly 50b. The outlet sensor assembly 140 may include a sensor assembly 152 similar to the outlet sensor assembly 104 discussed above. The outlet sensor assembly 140 may also include an outlet conduit connector 156 that can be connected to the outlet conduit 32. Therefore, the outlet sensor assembly 140 may be associated with the outlet 70' of the valve assembly 50b.

[0040] Therefore, valve assembly 50b may include any suitable valve assembly, such as one that does not include an internal or integrated sensor. However, inlet sensor assembly 120 and / or outlet sensor assembly 140 may be connected to valve assembly 50b at appropriate times. Inlet sensor assembly 120 and outlet sensor assembly 140 can provide inlet sensor information and outlet sensor information similar to those provided by inlet sensor 100 and outlet sensor 104. Therefore, valve assembly 50b does not need to be manufactured or include an integrated sensor, but can instead utilize modular sensor assemblies 120, 140 to provide or sense sensor information. Furthermore, modular sensor assemblies 120, 140 may be provided to enhance and / or replace sensors in situations such as when an integrated sensor is provided in sensor assembly 50a discussed above.

[0041] As discussed above, according to various embodiments of valve assemblies 50a and 50b, sensors may be configured to sense information about the valve assembly and / or provide measurement results about information relative to the valve assembly and / or valve assembly. According to various embodiments, for example, sensors (such as sensors 100, 104, 110, 134, and 152) may be pressure sensors. Pressure sensors may be any suitable pressure sensor capable of sensing pressure within a corresponding volume. Pressure sensors may include pressure sensors sold by Injectsense, Inc., which has a business location in Minneapolis, Minnesota; pressure sensors sold by Micro, Inc., which has a business location in Fort Lauderdale, Florida; or pressure sensors sold by Christoph Miethke GmbH, Inc., which has a business location in Germany. It should be understood that pressure sensors may be configured to be mounted within valve assembly 50a and / or configured adjacent to valve assembly 50b, as discussed above. Therefore, sensors are typically selected based on size and power requirements to achieve placement relative to the corresponding valve assemblies 50a, 50b, and have a thickness of less than 1 mm and other dimensions ranging from about 1 mm to about 10 mm.

[0042] As discussed above, the valve assembly can be positioned relative to subject 14 during appropriate surgical procedures. For example, valve assembly 50 can be implanted in the subject, such as near the head or brain of subject 14. Following the surgery, monitoring of the operation of the shunt (including the valve assembly or control assembly 28) can be selected. This discussion may relate to or specifically describe valve assembly 50a; however, it should be understood that the valve assembly can be positioned in any suitable manner, and the discussion of valve assembly 50a is merely exemplary. For example, as... Figure 4 As illustrated, valve assembly 50a may be implanted relative to subject 14. Subject 14 may then be monitored after implantation of valve assembly 50a as part of shunt assembly 10. The shunt assembly may have an optimal operating range, which may include a selected flow rate through valve assembly 50a. However, blockage may occur in a portion of shunt assembly 10, which may reduce flow through shunt assembly 10, such as through valve assembly 50a. Therefore, a sensor may be able to operate to measure pressure at various portions of valve assembly 50a (or pressure relative to the valve assembly, as illustrated by a connectable and modular sensor for valve assembly 50b). As discussed and illustrated above, the sensor may sense pressure at various zones or volumes of valve assembly 50a. A signal associated with the sensed parameter (e.g., pressure) may then be transmitted for evaluation and further planning or adjustment of valve assembly 50a. This signal may be a raw signal processed to determine the measured pressure.

[0043] Parameter measurements and / or sensor readings may be acquired or collected at selected times. For example, a subject or patient 14 may enter or be placed in a medical facility or environment 198. Subject 14 may be positioned on a patient support (such as a patient bed 200). A device associated with and / or configured or operable relative to the patient bed 200 and intended to be portable relative to a subject (e.g., a user 204, such as a physician) may be a reader or sensing module 210. Sensing module 210 may have appropriate components such as a receiver or transceiver module 214, a memory and / or processor module 216, and a power source such as a battery 218 or a constant power source such as a wall power supply. Sensing module 210 may receive data from a sensor associated with valve assembly 50a. The sensor may then transmit data when activated by sensor assembly 210 (e.g., when a signal is transmitted by transceiver 214). During activation, signal 230 may be received at the sensor of valve assembly 50a. The sensor may then transmit sensor signal 234 for measurement or reception by sensor assembly 210.

[0044] Portable or sensor module 210 may be configured to be positioned relative to subject 14 in an appropriate manner. For example, portable unit 210 may be associated with bed 200 in a fixed or movable manner. Thus, sensor module 210 may be associated with support 200 when an appropriate or selected subject (such as subject 14) is positioned on support 200. Sensor module 210 may also be disposed within support (such as a pillow or other support for patient 14). However, sensor module 210 is typically positioned in an appropriate location relative to subject 14 to allow data transmission from subject valve assembly 50a.

[0045] According to various implementations, activation signal 230 can power the sensor or cause the sensor to transmit sensor signal 234. Activation signal can cause the sensor to resonate to provide power for signal transmission, wake the sensor and transmit signals, or other suitable applications. However, sensor signal 234 can be received at portable unit 210. Sensor signal 234 can include various information, such as pressure signals based on pressure sensed by the sensor, temperature, or other suitable information. Transceiver 214 can then transmit sensor unit signal 240 including sensor information based on sensor signal 234. Other sensors, such as temperature sensors, pressure sensors, humidity sensors, or other suitable sensors and sensor module 244, can be present at portable module 210. Sensor module 244 can be an environmental sensor module that measures parameters of medical facility room 198. Thus, the pressure sensed at valve assembly 50a can be compared with ambient pressure to help determine actual or absolute pressure. Therefore, sensor module 210 can also utilize signal 240 to transmit environmental measurement results measured at sensor module 244, separate from the sensor associated with valve assembly 50a within the subject 14.

[0046] The data collection or transmission system 250 can also be portable, such as being able to move with the user 204. The portable or handheld unit 250 can receive signal 240. The handheld unit 250 may also include a processor 254, a memory module 258, and a power unit or power source 262. The portable unit 250 may also include a viewing screen 266 and / or various input units, such as a touchscreen or other input buttons or keys 268. The portable unit 250 can be moved by the user to collect data from the portable unit or sensor module 210. For example, the user 204 may move to multiple subjects 14 and collect sensor data from multiple valve assemblies 50.

[0047] Data collected by portable unit 250 may then be transmitted to a server or cloud system 280. Cloud system 280 may include one or more processor modules 284 and one or more memory modules 288. Thus, cloud system 280 may receive data already collected from sensor module 210 from portable unit 250, including environmental measurements and measurements from patient 14, such as those from sensors associated with valve assembly 50a. Therefore, data may be collected by user 204 at appropriate intervals, such as based on treatment of subject 14, physician prescriptions, or orders. Data regarding the sensed pressure at valve assembly 50a may be collected for various purposes, as further discussed herein.

[0048] Go to Figure 5Subject 14 can be repositioned within medical facility 198. Patient 14 can be supported by a selective support (such as support 200). The physician's compartment implanted in the subject can be valve assembly 50a. Valve assembly 50a can again include sensors, as discussed above. The sensors can sense features relative to valve assembly 50a, also discussed above.

[0049] like Figure 5 As illustrated, a patient-wearable and / or patient-implanted transceiver assembly 300 may be configured. The transceiver assembly 300 may include all portions of the sensor module 210 discussed above. Therefore, the patient-wearable receiver module may include a processor module, a memory module, a power module (e.g., a battery), and a sensor module. Thus, the patient-wearable sensor module 200 may again transmit a signal activating the sensor of the valve assembly 50a. This signal may power the sensor, provide a wake-up signal to the sensor, or provide other appropriate signals. The sensor at the valve assembly 50a may transmit a sensor signal 310, which may be received at the patient-wearable sensor module 300. The sensor signal 310 may be similar to the sensor signal 234 discussed above.

[0050] However, the patient wearable sensor module 300 can be provided to the subject 14 for more constant or fixed intervals without requiring the subject 14 to be positioned at the patient support 200. The patient wearable sensor module 300 can be selectively worn or selectively operated, for example, using a procedure, to collect sensor signals from the valve assembly at selected time intervals. Because the patient wearable sensor module 300 is always with the subject 14, or at selected times, the collection of sensor signals or sensor data can occur at smaller or more regular intervals than the sensor data collected by the portable module 210. Furthermore, the patient wearable sensor module 300 allows the subject 14 to move while still allowing data collection on sensor assemblies, such as sensors in the valve assembly 50a.

[0051] However, user 204 may still include or have a portable module 250 to receive sensor module signal 314. Sensor module signal 314 may be similar to sensor module signal 240 discussed above. Thus, sensor signals or measurement information from valve assembly 50a can be sent to unit 250. Unit 250 can then send the measurement results along with transmission signal 318 to cloud system 280, as discussed above. Thus, user 204 can collect information or measurement results at or from valve assembly 50a. Thus, measurement results regarding subject 14, such as pressure measurements, can be collected and analyzed, for example, at cloud system 280.

[0052] Furthermore, user 204 can collect or have signals transmitted from the subject wearable sensor module 300. Therefore, information regarding sensor measurements at valve assembly 50a can be collected at appropriate times. While user 200 can move portable module 250 relative to patient wearable sensor module 300 to collect sensor measurements, patient wearable module 300 can collect sensor measurements at appropriate intervals and store them in a memory module such as those discussed above. Therefore, patient wearable module 300 can allow collection at selected intervals, which can be longer than the intervals at which user 204 collects data using portable module 250.

[0053] Go to Figure 6 Subject 14 may implant valve assembly 50a therein. Valve assembly 50a may be similar to the valve assemblies discussed above and / or include alternative or additional features or portions as discussed herein. For example, valve assembly 50a may include memory and / or processor module 360. Furthermore, valve assembly 50a may include an adjustable valve mechanism or any suitable valve mechanism, such as the valve mechanism disclosed in U.S. Patent No. 11,701,503, published July 18, 2023, which is incorporated herein by reference. The valve mechanism may be adjustable within valve assembly 50a. Additionally, sensor assembly may transmit signals directly and / or via a transceiver (such as a transceiver associated with processor / memory module 360). Thus, valve assembly 50a including processor / memory module 360 ​​may collect sensor measurements at selected intervals and / or within selected time periods. Sensor measurements may be stored for transmission in valve assembly 50a (e.g., using memory / processor module 360).

[0054] Therefore, at a selected time, valve assembly 50a (such as including processor / memory module 360) can transmit sensor signal 364, which can be a set or dataset of multiple sensor measurements acquired within a selected time period and at selected intervals. No additional mechanism is required to obtain the sensor measurements. Portable component 250 can transmit activation signal 368, which activates the transmission of sensor signal 364.

[0055] Therefore, valve assembly 50a can be compact and requires no additional parts to ensure the collection of an appropriate amount of data regarding sensor measurements. Portable system 250 can transmit a send signal or activation signal 368 and receive sensor logs or sensor data 364. Portable module 250 can then use send signal 372 to transmit to cloud 280, as discussed above. Cloud assembly 280 can then evaluate the data, as discussed above and further herein.

[0056] Therefore, according to various embodiments, valve assembly 50a may include sensor assemblies as discussed above. It should be understood that valve assemblies according to various embodiments may include valve assembly 50b, and may include subject positioning according to various transmission schemes, as discussed above and as... Figure 4 , Figure 5 and Figure 6 As illustrated. Furthermore, each of the various delivery schemes includes various features or portions that allow sensor data to be acquired from the valve assembly 50 implanted in the subject 14 and to collect and transmit the data to the cloud of the system 280. It should be understood that the various exemplary embodiments discussed above may be integrated together and / or include or exclude various portions as discussed above. Therefore, as those skilled in the art will understand, the exemplary embodiments describe various features and modules, such as the patient wearable module 300, which may or may not be included in any suitable embodiment.

[0057] Data collected from sensors allows for analysis of the operation of the valve assembly 50 inserted into the subject 14. The data can be transmitted to a cloud component or cloud system 280 for analysis by executing instructions stored in a memory system (such as those discussed above). A processor module can execute instructions as further discussed herein. Pressure signals can relate to intracranial pressure relative to various portions or locations of the valve assembly 50 and can allow for analysis of selected flow rates through the valve assembly 50.

[0058] Various systems for providing sensors relative to subject 14 allow for the collection and transmission of sensor signals associated with measurements of sensor parameters, as discussed above. As further discussed above, sensor measurements can be sent to selected systems, such as cloud systems or server components, or any other suitable processing components for executing instructions based on the sensor measurements. According to various implementations, in Figure 7A and Figure 7B The illustrated process 400 can be used to analyze and provide various outputs based on sensor measurement results. Process 400 may include: determining the probability of blockage, illustrating or providing pressure measurement results in real time and / or over time, providing the probability of the location of the blockage, and providing a probability of results based on the determined probability of blockage and its location. It should be understood that, as discussed herein, any one or more outputs of various kinds may be output from system 400, and each output is merely exemplary. Therefore, system 400 may provide a single output and / or multiple outputs as discussed herein.

[0059] System 400 may begin in start box 410. Starting the system may include initializing the system, such as initializing the sensor after implantation or after powering the sensor. After starting this process or in start box 410, sensor data is acquired in box 414. Sensor data may include data from a first sensor (such as an input sensor), a second sensor (such as an output sensor), a third sensor (such as a storage sensor), or any other suitable sensor. As discussed above, shunt system 10 may include one or more sensors, and therefore, acquiring sensor data may include acquiring data from any one or more of the sensors.

[0060] According to the various embodiments discussed herein, the acquisition of sensor data allows for the analysis of sensor data. Furthermore, acquiring environmental data in block 418 can aid in the analysis of the sensor data acquired from block 414. For example, environmental data may include ambient pressure or ambient temperature, etc. Environmental data may include sensor measurements outside the subject 14. As discussed above, various parts of the system (such as data collection module 210 (e.g., sensors in sensor module 244)) can collect sensor measurements regarding the environment outside the subject 14. The environment outside the subject 14 can be the surrounding environment, such as within medical room 198. Environmental measurements can help determine or calculate the true pressure, thereby aiding in the calibration of sensor measurements of the shunt system 10, etc.

[0061] In box 422, the acquired data can be passed to a selected processing module, such as a cloud system or off-site server system. The transmission of sensor data may include data from both boxes 414 and 418. Therefore, any appropriate sensor data can be passed to the processor system for executing instructions and analyzing the data based on those instructions.

[0062] Data collected from various sensors (such as blocks 414 and 418) can be used for various analyses. Any appropriate analysis can occur sequentially or in parallel in any suitable manner. In various embodiments, flow analysis can occur in block 430. Flow analysis in block 430 may include flow subprocesses and various calculations or subprocesses within flow analysis 430. However, flow analysis can be used to determine or provide various outputs as discussed herein. Flow analysis can be a subprocess of process 400 for analyzing and providing outputs related to sensor measurements of the diversion system 10.

[0063] Initially, the acquired sensor data from the sensor can be calibrated to or calibrated using a calibration curve. The calibration curve can be unique for each sensor and can be per-sensor. That is, a sensor in a valve assembly (such as sensor 100, which serves as an input sensor in valve assembly 50a) can have a specific calibration curve, such as one generated during the manufacture and testing of sensor 100. The calibration curve can be used to calibrate or preprocess sensor data prior to further analysis. In various embodiments, the sensor signal from the sensor can be a raw signal. Preprocessing of the calibration curve can involve transforming the raw signal into a relevant measurement result for a parameter (e.g., pressure). In other words, the signal from the sensor (such as sensor 100) can be a raw data signal based on various conditions (such as pressure changes providing an electrical signal, e.g., signal changes). However, signal changes may require preprocessing using a calibration curve to determine the relevant pressure measurement result. Therefore, calibration at block 434 allows for the output of the actual measurement result for the selected parameter (e.g., pressure, temperature, etc.) at block 438. Thus, the acquired sensor data can be calibrated at block 434 of the flow analysis subprocess 430.

[0064] Once the sensor data is calibrated, the actual measurement results can be output based on the calibration in box 438. The output of the actual measurement results can be based on the sensor's calibration information. Therefore, sensor measurement results can be compared or preprocessed to output the actual measurement results.

[0065] In block 442, the flow rate difference can be determined based on actual pressure measurements. As discussed above, input sensor 100 can be positioned near the input of valve assembly 50a. Output sensor 104 can be positioned near the output of valve assembly 58. The difference determined at block 442 can be related to the flow rate within or through valve assembly 50a. It should be understood that any difference can be determined for any suitable valve assembly, including those discussed above, such as valve assembly 50b. However, the valve pressure difference is based on actual measurements that can be taken in block 442.

[0066] Based on the actual difference in pressure measurement results, the flow rate can be determined in box 446. The flow rate determination can be an actual flow rate (e.g., in millimeters per hour) or a comparative flow rate. For example, after initial implantation, an initial data collection cycle can be performed using the sensor assembly of the valve assembly. Comparison with later pressure differences can be used to determine whether the flow rate has increased or decreased. Such pressure difference measurements can be used to determine whether the flow rate through the valve assembly (such as valve assembly 50a) is occurring, has increased, or has decreased.

[0067] In box 448, a flow determination, including flow rate (if determined), can be output. The flow determination can be output from server system 280 to any suitable system, such as a user system including portable system 250. The output can be used for various purposes, as discussed herein.

[0068] According to various implementations, this allows signals from pressure sensors to be used in analysis 400 (including flow analysis subprocess 430) to measure or calculate the flow rate through valve system 50. The flow rate or volume generation can be used for various analyses and subject treatments as further discussed herein.

[0069] At any appropriate time, such as in parallel with flow analysis, there may be a blockage analysis in subprocess 460. Blockage analysis 460 may be an optional analysis based on sensor measurements as discussed above. Therefore, blockage analysis is not required in process 400, and process 400 may simply be the flow analysis in subprocess 430. However, if chosen, blockage subprocess 460 may be performed to help determine and / or locate blockages relative to valve assembly 50.

[0070] Blockage analysis 460 may include recalling stress history in box 464. Stress history may be specific to a particular subject (such as the current subject). In box 414, stress history may be recalled based on saved acquired sensor data, as discussed above. Furthermore, stress history may be based on trends across multiple subjects. Trends may be quantified or defined based on characteristics similar to the current subject, and / or simply as grouped datasets. In any case, stress history may be recalled in box 464, such as the stress history of the subject for whom sensor data was collected in box 414.

[0071] In box 468, the actual measurement results collected in real time can be retrieved. The actual real-time measurement results can be retrieved from the output of the actual measurement results in box 438, as discussed above. Therefore, the actual real-time measurement results can be based on comparison with environmental measurement results and / or calibration of various sensors.

[0072] Then, in box 472, the actual real-time pressure measurement can be compared with the invoked pressure. The comparison can be within a selected time period (e.g., minutes, hours, days, etc.). This comparison allows for comparison of the acquired data over a selected time period and the relevant actual measurement from a selected current real-time time (e.g., the past 12 hours) with a selected pressure history (such as a collection of sensor data from hours or days prior to the selected current or real-time time).

[0073] The comparison of actual real-time measurement results with the invoked pressure history or trend can be operated to allow the determination of the probability of blockage in box 476.

[0074] The probability of blockage can be determined based on comparisons from box 472. For example, if the pressure at any sensor in the sensor increases relative to the invoked pressure history, a possible blockage can be determined. Therefore, the increase value or percentage increase, etc., can be used to determine the probability of blockage in box 476.

[0075] The decision box can then follow the probability determination in box 476, including whether a blockage exists in box 480. If it is determined that no inclusion is present based on the determination in box 476, a "No" path 484 can be followed to the output of process 400 (e.g., displaying the UI), as discussed further herein. However, if an inclusion is determined to exist in box 476, a "Yes" path 488 can be followed. Therefore, the determination of the probability of inclusion in box 476 allows for splitting in process 400, including splitting in the blockage analysis subprocess 460.

[0076] If an inclusion is determined to be present, it may have reached a selected probability (e.g., greater than a selected percentage, such as 20%, 30%, 40%, or any appropriate percentage), and the most likely location can be determined in box 494.

[0077] When determining the probable location of a potential blockage already identified in block 476, a possible or probable location relative to valve assembly 50 may be permitted. As illustrated and discussed above, according to various embodiments, the valve assembly may include at least an inlet 64 and an outlet 70. Furthermore, according to various embodiments, the valve assembly includes a valve mechanism within the valve body of valve assembly 50. Therefore, according to various embodiments, the location of the blockage may be determined at the inlet or proximal portion of the valve assembly, at the outlet or distal portion of the valve assembly, or within the valve assembly, such as between the inlet and outlet and / or at the valve mechanism.

[0078] The determination of a probable location can be based on various measurements at a specific sensor location. For example, determining that a blockage is likely at the input can be based on a decrease in the sensed input pressure value and amplitude relative to a recalled pressure history. Therefore, in block 472, the recalled pressure history of the input or proximal pressure sensor can be compared with the actual real-time measurements. If the input pressure value and amplitude decrease in the real-time data relative to the recalled history, it can be determined that a blockage is likely at the input.

[0079] When the difference between the input and output pressure increases relative to the recalled pressure history, it can be determined whether the blockage is intermediate or within the valve mechanism. This allows for the determination of the most likely location of the blockage being intermediate between the input and output sections.

[0080] Furthermore, determining that the blockage is located at the output can be based on an increase in output pressure. Again, the increase in actual real-time measurements relative to the pressure history referenced at the output pressure sensor allows for the determination of the most likely location of the blockage at the output.

[0081] Therefore, after identifying a probable blockage in box 476, box 494 can be used to determine the probable location of the blockage. Process 400 allows for the determination of the blockage and its possible location relative to valve assembly 50.

[0082] Once the probable location is determined in box 494, it can be output in box 500. The output of the probable location in box 500 can be a visual output, a transmission of the probable location to a selected user interface (as discussed herein), or other appropriate output. In any case, the determination of the probability of congestion and the probable location of the congestion can be output for various purposes.

[0083] Prioritization analysis and / or trends based on the determined probabilities may be included in process 400. For example, a call to a clogging trend may be made in box 504. Calls to clogging trends may come from the outcomes of multiple subjects in the relevant treatment and subjects in similar situations. For example, multiple patients may include valve components of a shunt assembly implanted in their bodies, similar to valve component 50. If a clogging is found in the shunt assembly and the patient outcome is later determined, the location and outcome of the clogging may be compiled and stored for retrieval, such as in trend box 504. Specific patient data may not be retrieved or saved along with the clogging location and patient outcome, but trends may be saved for comparison with the current subject.

[0084] In box 510, the output of the determined probable location can be compared with the invoked trend. The comparison in box 510 can allow the output of the probable result of the comparison in box 514. As discussed above, if the probable location of the blockage is determined in box 494 and compared with the trend in box 510, the probable result for a specific or current subject can be output in box 514 based on the comparison. For example, if the blockage is output as a probable location in box 494, the result of another subject can be invoked in box 504 and compared with the distal or output blockage, compared with the probable location determined in box 510, and then output in box 514. Similarly, the output of box 514 can be any suitable output, such as visual output, auditory output, saved to a selected memory for retrieval, displayed on a user interface, or other suitable output unit.

[0085] Following the output of the likely outcome comparison in box 514, the path to "A" can be followed to save selected data in box 520. Selected data may include flow rate, pressure from sensor measurements, and / or blockage analysis. Blockage analysis may include both the probability of blockage presence and the probability of blockage location. Therefore, in box 520, data based on the acquired sensor data and the correlation analysis in flow analysis 430, as well as the blockage analysis in box 460, can be saved. Data from the analysis can be saved in any suitable manner, such as in a memory system as discussed above and / or as part of a cloud or processor component 280.

[0086] In box 520, data may optionally be saved for later retrieval and / or access in box 524. Alternatively, data and / or analysis may be immediately accessible for further processing in process 400, as discussed herein. Thus, as discussed above, various sensor data and outputs may be displayed at a user interface (UI) in box 530. The display for the user at the UI may be a display of any of the appropriate data and / or analysis, including those discussed above. The display may include specific actual measurements from box 438, flow determination output from box 448, determined probability of blockage in box 480, determined probable location of blockage from box 494, output of probable results of comparisons in box 514, or any other appropriate display. Thus, user 204 may view data and analysis outputs and interact with or based on the user interface. The user interface may be part of cloud system 280 and / or any other appropriate system, such as portable device 250.

[0087] This allows user 204 to input or manipulate data or data analysis in box 534. For example, the user can use the UI to view pressure measurement results and / or a probable determination of blockage or flow rate, etc. The user can make a determination for further follow-up and / or manipulation of the valve assembly of the subject based on the sensor measurement results and / or analysis as discussed above.

[0088] In box 538, the user can also select the data to be used for the subject record. Selection of user data for the subject record can include saving or selecting data to be saved in the subject record. For example, if it is determined that there is no congestion or the analysis provides a probability outside the selected range, the selected data may not be saved in the subject record. However, in box 538, the user can select the data to be used for the subject record.

[0089] Then, in box 542, data can be selected to be displayed to the subject. That is, the user (such as a physician) can choose to allow notification of selected data to subject 14. For example, if a likely blockage is determined, the physician can select data to be displayed to the subject in box 542, such as an instruction for subject 14 to contact the user for follow-up. Therefore, in box 548, the selected subject data can be displayed in the subject's user interface.

[0090] Based on selected data (such as data displayed to and / or selected by the user), instructions for manipulating the implant can be made or provided in box 554. For example, the user can select a regulating valve assembly based on the flow rate output in box 448 and determined in box 446. Instructions for regulation can be provided or determined in box 554, such as based on selected measurements and / or analyzed measurements, to determine flow or blockage. Therefore, process 400 may include entering a regulation value or type and / or actual regulation in box 560.

[0091] If no adjustment is selected, the process 400 can be terminated in box 570 by following the "No" path 564. If manipulation is selected, the adjustment or manipulation can be output in box 578 by following the "Yes" path 574. As discussed above, the valve assembly may include an adjustable valve that can be adjusted by a manual regulator, such as by a user, located outside the subject 14. The external regulator may include one capable of interacting with Strata ® StrataVarius with valves operating together ® The regulating system and / or the ability to interact with other valve systems (such as Delta) ® The regulating system, which operates together with the valve, is sold by Medtronic, Inc., a company with a business location in Minnesota, USA. The regulating system may be a manual regulator of the valve mechanism 76 of the regulating valve assembly 50. Alternatively, the valve mechanism may be regulated using an internal regulating mechanism, such as the internal regulating mechanism disclosed in U.S. Patent No. 11,701,503, which is incorporated herein by reference. In any case, the output in block 578 may include instructions to a user, instructions to an alternative user, or instructions executed by an internal regulating mechanism, to provide regulation or instructions to the internal regulating mechanism to regulate the valve mechanism 76.

[0092] After outputting the adjustment / manipulation in box 578, the process can also end in box 570.

[0093] Therefore, process 400 can be used to collect sensor data, determine measurements of selected parameters, help determine selected parameters associated with the valve assembly (such as flow rate or probability of blockage), and possible outputs for manipulating the valve assembly. Thus, the system described above allows the shunt assembly 10 to be implanted in the subject 14 and parameter measurements to be collected based on sensor measurements included in and / or adjacent to the valve assembly. The sensor measurements can be used according to process 400 to help provide analysis of the collected sensor measurements for possible further follow-up of the subject 14.

[0094] Example 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, 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.

[0095] Instructions can be executed by a processor and may include software, firmware, and / or microcode, and may refer to programs, routines, functions, classes, data structures, and / or objects. The term "shared processor circuitry" covers a single processor circuitry that executes some or all of the code from multiple modules. The term "group processor circuitry" covers processor circuitry that, in conjunction with additional processor circuitry, executes some or all of the code from one or more modules. References to multiple processor circuitry cover multiple processor circuitry on a discrete die, multiple processor circuitry on a single die, multiple cores of a single processor circuitry, multiple threads of a single processor circuitry, or a combination thereof. The term "shared memory circuitry" covers a single memory circuitry that stores some or all of the code from multiple modules. The term "group memory circuitry" covers memory circuitry that, in conjunction with additional memory, stores some or all of the code from one or more modules.

[0096] The apparatus and methods described in this application may be implemented, in part or in whole, by a processor (also referred to as a processor module), which may include a special-purpose computer (e.g., created by configuring a processor) and / or a general-purpose computer for performing one or more specific functions embodied in a computer program. The computer program includes processor-executable instructions stored on at least one non-transitory, tangible computer-readable medium. The computer program may also include or depend on stored data. The computer program may include a basic input / output system (BIOS) that interacts with the hardware of the special-purpose computer, a device driver that interacts with a specific device of the special-purpose computer, one or more operating systems, user applications, background services, background applications, etc.

[0097] Computer programs may include: (i) assembly code; (ii) object code generated from source code by a compiler; (iii) source code for execution by an interpreter; (iv) source code for compilation and execution by a just-in-time (JIT) compiler; and (v) descriptive text for parsing, such as HTML (Hypertext Markup Language) or XML (Extensible Markup Language). As an example only, source code may be in C, C++, C#, Objective-C, Haskell, Go, SQL, Lisp, or Java. ® ASP, Perl, Javascript ® HTML5, Ada, Active Server Pages (ASP), Perl, Scala, Erlang, Ruby, Flash ® Visual Basic ® Lua or Python ® To write it.

[0098] Communication may include the wireless communications described in this disclosure, which may be wholly or partially compliant with IEEE Standard 802.11-2012, IEEE Standard 802.16-2009, and / or IEEE Standard 802.20-2008. In various specific implementations, IEEE 802.11-2012 may be supplemented by draft IEEE Standard 802.11ac, draft IEEE Standard 802.11ad, and / or draft IEEE Standard 802.11ah.

[0099] The terms processor, processor module, module, or “controller” are used interchangeably herein (unless otherwise specifically indicated), and each may be replaced by the term “circuit”. Any of these terms may refer to, be part of, or include: application-specific integrated circuit (ASIC); digital, analog, or mixed-signal analog / digital discrete circuit; digital, analog, or mixed-signal analog / digital integrated circuit; combinational logic circuit; field-programmable gate array (FPGA); processor circuitry (shared, dedicated, or grouped) that executes code; memory circuitry (shared, dedicated, or grouped) that stores code executed by the processor circuitry; other suitable hardware components that provide the described functionality; or combinations of some or all of the foregoing, such as in a system-on-a-chip.

[0100] Instructions may be executed by one or more processors or processor modules, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Therefore, the terms "processor" or "processor module" as used herein may refer to any of the foregoing structures or any other physical structure suitable for implementing the described techniques. Furthermore, these techniques may be fully implemented in one or more circuit or logic elements. The one or more processors may operate fully automatically and / or substantially automatically. In automatic operation, the processor may execute instructions based on received inputs and in accordance with received inputs. Therefore, various outputs may be performed without additional or any manual (e.g., user) input.

[0101] 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 the invention. 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 chosen embodiments where applicable, even if not specifically shown or described. The same element or feature may be varied in many ways. Such variations are not considered to depart from the invention, and all such modifications are intended to be included within the scope of the invention.

Claims

1. A shunt system configured to measure parameters of a subject shunt, the shunt system comprising: A valve assembly configured to allow selected flow rates through an inlet and an outlet; A first sensor, associated with the valve assembly, is used to sense pressure near at least one of the inlet or the outlet. A data collection module configured to receive sensor signals related to the sensed pressure from the first sensor; and A processor module configured to execute instructions to analyze the sensor signals relating to the state of the valve assembly.

2. The diversion system according to claim 1, further comprising: Second sensor: The first sensor is configured to sense the pressure at the inlet, and the second sensor is configured to sense the pressure at the outlet.

3. The diversion system according to claim 2, further comprising: A first sensor housing, configured to house the first sensor and selectively connected to the inlet of the valve assembly; and A second sensor housing is configured to house the second sensor and is selectively connected to the outlet of the valve assembly.

4. The diversion system according to claim 2, further comprising: A first sensor housing, configured to house the first sensor and integrated with the valve assembly; and A second sensor housing is configured to house the second sensor and is integrated with the valve assembly.

5. The diversion system according to claim 2, further comprising: A valve mechanism, which is selectively configured to achieve the selected flow rate.

6. The shunt system of claim 2, wherein the valve assembly is configured to be implanted in a human subject to allow cerebrospinal fluid to drain from the ventricles.

7. The flow splitting system of claim 2, wherein the processor module is configured to execute instructions to determine whether a selected flow rate has been achieved.

8. The diversion system of claim 2, wherein the processor module is configured to execute instructions to determine the probability of blockage at the valve assembly.

9. The diversion system of claim 2, wherein the processor module is configured to execute instructions to determine the probability of a blockage relative to the position of the valve assembly.

10. The diversion system according to claim 2, further comprising: A user interface system having at least one output system and one input system, the at least one output system and the at least one input system being operable to allow a user to at least understand the analysis of the sensor signals generated by the processor module.

11. A method for collecting data from a distribution system, the method comprising: Receive a first sensor signal from a first sensor associated with the valve assembly to sense pressure near at least one of the inlet or outlet of the valve assembly; The data collection module is used to collect data from the first sensor signal; as well as The processor module is used to execute instructions to analyze the first sensor signal regarding the state of the valve assembly.

12. The method according to claim 11, further comprising: Receive a second sensor signal from a second sensor associated with the valve assembly; The first sensor is configured to sense the pressure at the inlet, and the second sensor is configured to sense the pressure at the outlet.

13. The method according to claim 12, further comprising: The valve assembly is configured to allow selected flow rates through the inlet and the outlet.

14. The method according to claim 13, further comprising: The first sensor is housed in a first sensor housing, which is configured to be selectively connected to the inlet of the valve assembly; as well as The second sensor is housed in a second sensor housing, which is configured to be selectively connected to the outlet of the valve assembly.

15. The method according to claim 13, further comprising: The valve assembly is configured to include a first sensor housing, the first sensor housing being configured to accommodate the first sensor; as well as The valve assembly is configured to include a second sensor housing, the second sensor housing being configured to accommodate the second sensor.

16. The method according to claim 13, further comprising: A valve mechanism is provided within the valve assembly, and the valve mechanism is selectively configured to achieve the selected flow rate.

17. The method according to claim 13, further comprising: The valve mechanism is disposed within the valve assembly, and the first and second sensors to be implanted in a human subject are disposed therein to allow cerebrospinal fluid to be drained from the ventricles of the human subject.

18. The method according to claim 13, further comprising: The processor module is operated to execute instructions to determine whether the selected flow rate has been achieved.

19. The method according to claim 13, further comprising: The processor module is operated to execute instructions to determine at least one of the following: (1) the probability of blockage at the valve assembly, or (2) the probability of blockage relative to the position of the valve assembly.

20. The method according to claim 13, further comprising: A user interface system is configured, the user interface system having at least one output system and one input system, the at least one output system and the at least one input system being operable to allow a user to at least understand the analysis of the sensor signals generated by the processor module.

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