Description:FIELD OF DISCLOSURE
The present disclosure relates to medical devices for monitoring cerebrospinal fluid, and more particularly to adapter, system, and method for continuous cerebrospinal fluid analyte monitoring.
BACKGROUND
Cerebrospinal fluid (CSF) is a clear, colorless fluid that surrounds the brain and spinal cord, providing crucial protection, nutrient delivery, and waste removal for the central nervous system. Monitoring CSF composition and dynamics can provide valuable insights into neurological health and disease processes. Continuous measurement of CSF analytes, such as glucose levels, has potential applications in diagnosing and managing various neurological conditions.
Conventional methods for analyzing CSF typically involve intermittent sampling through lumbar puncture or ventricular access, which are invasive procedures that carry risks and provide only periodic snapshots of CSF composition. Some existing systems utilize implantable sensors or external drainage devices with integrated monitoring capabilities. However, these approaches often suffer from limitations such as short functional lifespans, drift in sensor accuracy over time, risk of infection, and inability to provide truly continuous real-time data. Additionally, many current CSF monitoring technologies are not well-suited for long-term use or integration with standard clinical drainage systems.
Efforts to develop improved CSF monitoring solutions have explored various sensing modalities and device designs. While progress has been made, challenges remain in achieving reliable long-term performance, minimizing invasiveness, and seamlessly integrating monitoring capabilities with existing clinical workflows and equipment. Furthermore, data analysis and interpretation methods for continuous CSF monitoring are still evolving, presenting opportunities for enhancing the clinical utility of these technologies.
Therefore, there exists a need for a technical solution that solves the aforementioned problems of conventional systems and methods for continuous monitoring of cerebrospinal fluid.
SUMMARY
This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
In an aspect of the present disclosure, an adapter is disclosed. The adapter includes a housing. The adapter includes one or more sensors disposed within the housing. The one or more sensors are configured to sense, at a plurality of time instances, a plurality of signals that represents an analyte level in Cerebrospinal fluid (CSF) collected by the drainage apparatus. The adapter includes a connector configured to be coupled to the drainage apparatus to direct the flow of the CSF towards the one or more sensors. The adapter includes processing circuitry that is coupled to the one or more sensors. The processing circuitry is configured to determine a plurality of readings based on the plurality of sensed signals corresponding to the plurality of time instances. The processing circuitry is configured to determine/receive a base analyte value. The processing circuitry is configured to determine a threshold analyte value. The threshold analyte value is a predefined fraction of the base analyte value. The processing circuitry is configured to perform a linear trend analysis one or more recent readings from the plurality of readings. The processing circuitry is configured to predict, based on the linear trend analysis, a future time at which the analyte level is going to reach the threshold value. The processing circuitry is configured to generate an alert when the future time is within a predetermined time frame.
In some aspects of the present disclosure, the housing is made up of a biocompatible material configured to minimize interference with the flow of the CSF.
In some aspects of the present disclosure, the one or more sensors are CGM sensors.
In some aspects of the present disclosure, the plurality of time instances are five minutes apart.
In some aspects of the present disclosure, the connector includes a one-way valve configured to prevent backflow of the CSF into the drainage apparatus.
In some aspects of the present disclosure, the adapter includes a filter disposed between the connector and the one or more sensors. The filter is configured to remove particulates from the CSF before the CSF reaches the one or more sensors.
In some aspects of the present disclosure, the analyte is glucose.
In an aspect of the present disclosure, a system is disclosed. The system includes a drainage apparatus configured to collect CSF from a user. The system includes an adapter configured to be coupled to the drainage apparatus. The adapter includes a housing. The adapter includes one or more sensors disposed within the housing. The one or more sensors are configured to sense, at a plurality of time instances, a plurality of signals that represents an analyte level in Cerebrospinal fluid (CSF) collected by the drainage apparatus. The adapter includes a connector configured to be coupled to the drainage apparatus to direct the flow of the CSF towards the one or more sensors. The adapter includes processing circuitry that is coupled to the one or more sensors. The processing circuitry is configured to determine a plurality of readings based on the plurality of sensed signals corresponding to the plurality of time instances. The processing circuitry is configured to determine/receive a base analyte value. The processing circuitry is configured to determine a threshold analyte value. The threshold analyte value is a predefined fraction of the base analyte value. The processing circuitry is configured to perform a linear trend analysis one or more recent readings from the plurality of readings. The processing circuitry is configured to predict, based on the linear trend analysis, a future time at which the analyte level is going to reach the threshold value. The processing circuitry is configured to generate an alert when the future time is within a predetermined time frame.
In some aspects of the present disclosure, the housing is made up of a biocompatible material configured to minimize interference with the flow of the CSF.
In some aspects of the present disclosure, the one or more sensors are CGM sensors.
In some aspects of the present disclosure, the plurality of time instances are five minutes apart.
In some aspects of the present disclosure, the connector includes a one-way valve configured to prevent backflow of the CSF into the drainage apparatus.
In some aspects of the present disclosure, the system includes a filter disposed between the connector and the one or more sensors. The filter is configured to remove particulates from the CSF before the CSF reaches the one or more sensors.
In some aspects of the present disclosure, the analyte is glucose.
In an aspect of the present disclosure, a method is disclosed. The method includes collecting cerebrospinal fluid (CSF) from a user using a drainage apparatus. The method includes directing the flow of the CSF towards one or more sensors disposed within a housing of an adapter coupled to the drainage apparatus. The method includes sensing, by the one or more sensors at a plurality of time instances, a plurality of signals that represents an analyte level in the CSF. The method includes determining, by processing circuitry, a plurality of readings based on the plurality of sensed signals corresponding to the plurality of time instances. The method includes determining/receiving, by the processing circuitry, a base analyte value. The method includes determining, by the processing circuitry, a threshold analyte value. The threshold analyte value is a predefined fraction of the base analyte value. The method includes performing, by the processing circuitry, a linear trend analysis on one or more recent readings from the plurality of readings. The method includes predicting, by the processing circuitry based on the linear trend analysis, a future time at which the analyte level is going to reach the threshold value. The method includes generating, by the processing circuitry, an alert when the future time is within a predetermined time frame.
In some aspects of the present disclosure, the housing is made up of a biocompatible material configured to minimize interference with the flow of the CSF.
In some aspects of the present disclosure, the one or more sensors are CGM sensors.
In some aspects of the present disclosure, the plurality of time instances are five minutes apart.
In some aspects of the present disclosure, the method includes preventing backflow of the CSF into the drainage apparatus using a one-way valve in a connector of the adapter.
In some aspects of the present disclosure, the method includes filtering the CSF using a filter disposed between a connector of the adapter and the one or more sensors to remove particulates from the CSF before the CSF reaches the one or more sensors.
In some aspects of the present disclosure, the analyte is glucose.
In some aspects of the present disclosure, the method includes displaying a real-time graph of the plurality of readings, the base analyte value, and the threshold analyte value.
In some aspects of the present disclosure, the method includes updating the real-time graph to include a visual indicator of the predicted future time at which the analyte level will reach the threshold value.
In some aspects of the present disclosure, generating the alert includes providing a visual alert on a display and an audible alarm.
The foregoing general description of the illustrative aspects and the following detailed description thereof are merely exemplary aspects of the teachings of this disclosure and are not restrictive.
BRIEF DESCRIPTION OF FIGURES
The following detailed description of the preferred aspects of the present disclosure will be better understood when read in conjunction with the appended drawings. The present disclosure is illustrated by way of example, and not limited by the accompanying figures, in which like references indicate similar elements.
FIG. 1 illustrates a system for monitoring cerebrospinal fluid, according to aspects of the present disclosure;
FIG. 2A illustrates a perspective view of an adapter for the system of FIG. 1, according to aspects of the present disclosure;
FIG. 2B illustrates another view of the adapter of FIG. 2A, according to aspects of the present disclosure;
FIG. 3 illustrates a block diagram of processing circuitry for the system of FIG. 1, according to aspects of the present disclosure; and
FIG. 4 illustrates a flowchart of a method for monitoring cerebrospinal fluid, according to aspects of the present disclosure.
DETAILED DESCRIPTION
The following description sets forth exemplary aspects of the present disclosure. It should be recognized, however, that such description is not intended as a limitation on the scope of the present disclosure. Rather, the description also encompasses combinations and modifications to those exemplary aspects described herein.
The present disclosure relates to medical devices for monitoring cerebrospinal fluid (CSF), and more particularly to an adapter, system, and method for continuous CSF analyte monitoring. The invention provides a solution for real-time, continuous monitoring of CSF analyte levels, particularly glucose, which can be crucial for early detection of neurological conditions such as meningitis. By integrating with existing CSF drainage systems, the disclosed adapter and system offer a non-invasive approach to continuous monitoring, potentially improving patient outcomes through early intervention. The invention utilizes continuous glucose monitoring (CGM) technology adapted for CSF, enabling healthcare providers to track trends and predict critical changes in CSF composition. This approach may reduce diagnostic delays, enhance clinical decision-making, and ultimately lead to more effective management of neurological conditions.
FIG. 1 illustrates a system for monitoring cerebrospinal fluid, according to aspects of the present disclosure. The system 100 includes a drainage apparatus 102 connected to an outlet tube 103. A three-way valve 104 is positioned along the fluid path to control the flow direction. The outlet tube 103 extends from the three-way valve 104 to a collection container 106. An adapter 108 is integrated into the system 100 between components to enable monitoring of the cerebrospinal fluid.
The drainage apparatus 102 may be configured to collect cerebrospinal fluid (CSF) from a user. The drainage apparatus 102 may include various components such as catheters, tubes, and connectors designed for safe and effective CSF collection. In some aspects of the present disclosure, the drainage apparatus 102 may be an external ventricular drain (EVD) system or a lumbar drain system.
The outlet tube 103 may be configured to direct the flow of CSF from the drainage apparatus 102 to other components of the system 100. The outlet tube 103 may be made of biocompatible materials suitable for medical use and may have various dimensions to accommodate different flow rates and system configurations.
The three-way valve 104 may be configured to control the direction of CSF flow within the system 100. The three-way valve 104 may allow for selective routing of CSF to different components, such as the collection container 106 or the adapter 108. In some aspects of the present disclosure, the three-way valve 104 may be manually operated or electronically controlled to manage CSF flow.
The collection container 106 may be configured to receive and store CSF collected by the drainage apparatus 102. The collection container 106 may be designed to maintain sterility and allow for accurate measurement of CSF volume. In some aspects of the present disclosure, the collection container 106 may include markings or sensors to monitor CSF output over time.
The adapter 108 may be configured to interface with the existing components of the system 100 to enable fluid monitoring capabilities. The adapter 108 may contain sensors and processing circuitry for analyzing CSF composition, particularly glucose levels. In some aspects of the present disclosure, the adapter 108 may be designed for easy integration with standard CSF drainage systems without compromising their primary function.
Although FIG. 1 illustrates that the system 100 includes a single drainage apparatus 102, it will be apparent to a person skilled in the art that the scope of the present disclosure is not limited to it. In various other aspects, the system 100 may include multiple drainage apparatuses without deviating from the scope of the present disclosure. In such a scenario, each drainage apparatus is configured to perform one or more operations in a manner similar to the operations of the drainage apparatus 102 as described herein.
In operation, the system 100 collects CSF from a user via the drainage apparatus 102, directs the CSF through the outlet tube 103 and three-way valve 104, allowing for controlled flow to either the collection container 106 or the adapter 108 for analysis. The adapter 108 continuously monitors CSF analyte levels, particularly glucose, providing real-time data for clinical assessment and early detection of potential neurological issues.
FIG. 2A illustrates a sectional view of an adapter 108. The adapter 108 includes a housing 200 that forms the main body of the device. A connector 202 is provided at one end of the housing 200, configured to couple the adapter 108 to a drainage apparatus. The connector 202 incorporates a one-way valve 208 that regulates fluid flow through the adapter 108.
The housing 200 may be configured to enclose and protect the internal components of the adapter 108. The housing 200 may be made of biocompatible materials suitable for medical use and designed to minimize interference with CSF flow. In some aspects of the present disclosure, the housing 200 may be constructed from materials that are resistant to biofouling and compatible with sterilization procedures.
The connector 202 may be configured to securely attach the adapter 108 to the drainage apparatus 102 or other components of the CSF drainage system. The connector 202 may be designed to ensure a leak-free connection and maintain system sterility. In some aspects of the present disclosure, the connector 202 may be compatible with standard medical tubing and fittings used in CSF drainage systems.
The one-way valve 208 may be configured to prevent backflow of CSF into the drainage apparatus 102. The one-way valve 208 may help maintain the integrity of the CSF drainage system and prevent potential contamination. In some aspects of the present disclosure, the one-way valve 208 may be designed to open at a specific pressure to ensure proper CSF flow while preventing retrograde movement.
Examples of the one-way valve 208 may include, but are not limited to, a duckbill valve, a ball check valve, a diaphragm valve, or a flapper valve. Aspects of the present disclosure are intended to include and/or otherwise cover any type of the one-way valve 208 known to a person having ordinary skill in the art, without deviating from the scope of the present disclosure.
FIG. 2B illustrates a top view of the adapter 108. The adapter 108 includes a particulate filter 210 positioned within the flow path of the cerebrospinal fluid. The one or more sensors 204 are disposed downstream of the particulate filter 210 to measure analyte levels in the filtered cerebrospinal fluid. The processing circuit 206 is operatively connected to the one or more sensors 204 to receive and process the sensor signals. A memory (not shown) is coupled with the processing circuitry 206 and may be configured to store data related to the CSF monitoring process.
The particulate filter 210 may be configured to remove particles from the CSF before it reaches the one or more sensors 204. The particulate filter 210 may help maintain measurement accuracy by preventing debris or cellular material from interfering with sensor function. In some aspects of the present disclosure, the particulate filter 210 may have a pore size selected to remove particles larger than a predetermined threshold while allowing free passage of glucose and other analytes of interest.
The one or more sensors 204 may be configured to sense, at a plurality of time instances, a plurality of signals that represents an analyte level in CSF collected by the drainage apparatus 102. In some aspects of the present disclosure, the one or more sensors 204 may be continuous glucose monitoring (CGM) sensors adapted for use with CSF. The one or more sensors 204 may utilize various sensing modalities, such as electrochemical, optical, or fluorescence-based detection methods.
Examples of the one or more sensors 204 may include, but are not limited to, electrochemical glucose sensors, optical glucose sensors, enzyme-based glucose sensors, or fluorescence-based glucose sensors. Aspects of the present disclosure are intended to include and/or otherwise cover any type of the one or more sensors 204 known to a person having ordinary skill in the art, without deviating from the scope of the present disclosure.
The processing circuit 206 may be configured to receive and process signals from the one or more sensors 204. The processing circuit 206 may perform various operations, including signal processing, data analysis, and generation of alerts based on detected analyte levels. In some aspects of the present disclosure, the processing circuit 206 may include multiple specialized engines for different processing tasks.
The memory (not shown) may be configured to store various types of data related to the CSF monitoring process. This may include raw sensor data, processed readings, historical trends, patient-specific parameters, and system configuration settings. The memory may allow for both short-term and long-term data storage, enabling retrospective analysis and system optimization.
Although the processing circuitry 206 is shown to be part of the adapter 108 in this aspect, it will be apparent to a person skilled in the art that the scope of the present disclosure is not limited to it. In various other aspects, the system 100 may utilize an external processing circuitry without deviating from the scope of the present disclosure. Such external processing circuitry may be located in a separate device or integrated into existing medical equipment, allowing for more computational power or centralized data processing.
FIG. 3 illustrates a block diagram of a processing circuitry 206. The processing circuitry 206 includes a signal processing engine 300, a base value determination engine 302, a threshold determination engine 304, a trend analysis engine 306, a prediction engine 308, and an alert generation engine 310. The components are interconnected via a data bus 312 that enables communication between the various engines and the memory (not shown).
The signal processing engine 300 may be configured to process signals received from the one or more sensors 204 to determine glucose readings. The signal processing engine 300 may apply various filtering techniques, calibration algorithms, and noise reduction methods to enhance the accuracy of the glucose measurements. In some aspects of the present disclosure, the signal processing engine 300 may compensate for sensor drift or other factors that could affect measurement reliability over time.
The base value determination engine 302 may be configured to analyze the processed readings to determine a base glucose value. The base analyte value may represent a reference point for normal CSF glucose levels for the individual patient. In some aspects of the present disclosure, the base value determination engine 302 may calculate the base analyte value using statistical methods, such as averaging readings over a specified time period or identifying stable glucose levels during periods of minimal fluctuation. In some alternative aspects of the present disclosure, the base value determination engine 302 may be configured to receive the base analyte value from a user. Specifically, the user may input the base analyte value through a user interface (not shown) such that the base value determination engine 302 utilizes the provided base analyte value for further processing.
The threshold determination engine 304 may be configured to calculate a threshold value based on the determined base value. In some aspects of the present disclosure, the threshold value may be set as a predefined fraction of the base value, such as two-thirds of the base value. The threshold determination engine 304 may adjust the threshold value dynamically based on changes in the base value or other clinical factors. Aspects of the present disclosure are intended to include and/or otherwise cover any predefined fraction provided by the user to set the threshold value, without deviating from the scope of the present disclosure.
The trend analysis engine 306 may be configured to perform analysis on recent glucose readings to identify trends in the data. The trend analysis engine 306 may utilize various statistical and mathematical techniques to detect patterns, such as rising or falling glucose levels, over different time scales. In some aspects of the present disclosure, the trend analysis engine 306 may employ linear regression, moving averages, or more advanced time series analysis methods to characterize glucose trends.
The prediction engine 308 may be configured to use the trend analysis to predict when glucose levels will reach the threshold value. The prediction engine 308 may extrapolate current trends to estimate the time at which the glucose level is likely to cross the threshold. In some aspects of the present disclosure, the prediction engine 308 may incorporate machine learning algorithms to improve prediction accuracy based on historical data and patient-specific factors.
The alert generation engine 310 may be configured to monitor the predictions and generate alerts when certain conditions are met. The alert generation engine 310 may trigger warnings when the predicted time to reach the threshold value falls within a predetermined timeframe. In some aspects of the present disclosure, the alert generation engine 310 may produce different types of alerts based on the urgency of the situation, such as visual displays, audible alarms, or notifications sent to healthcare providers' devices.
The data bus 312 may be configured to facilitate bidirectional communication between the signal processing engine 300, base value determination engine 302, threshold determination engine 304, trend analysis engine 306, prediction engine 308, alert generation engine 310, and the memory, allowing the components to share data and coordinate their operations. The data bus 312 may enable efficient data transfer and synchronization between the various engines of the processing circuitry 206 and the memory.
In operation, the processing circuitry 206 continuously processes sensor signals, determines base and threshold values, analyzes trends, predicts future glucose levels, and generates alerts when necessary. The memory stores relevant data throughout this process, enabling both real-time analysis and retrospective review. This integrated approach enables real-time monitoring of CSF glucose levels and early detection of potential neurological issues, such as meningitis.
FIG. 4 illustrates a flowchart of a method 400 for monitoring cerebrospinal fluid (CSF). The method 400 begins at step 402, where CSF is collected from a user using a drainage apparatus. At step 404, the CSF flow is directed towards sensors in an adapter.
At step 402, the system 100 collects cerebrospinal fluid (CSF) from a user using a drainage apparatus 102. The drainage apparatus 102 may be an external ventricular drain or a lumbar drain system that is surgically implanted or externally connected to the patient. The CSF collection process may be continuous or intermittent, depending on the clinical requirements and the specific drainage system used.
At step 404, the system 100 directs the flow of the CSF towards one or more sensors 204 disposed within a housing 200 of an adapter 108 coupled to the drainage apparatus 102. The CSF may flow through the outlet tube 103 and be directed by the three-way valve 104 towards the adapter 108. The connector 202 of the adapter 108 may ensure a secure and sterile connection to the drainage system.
At step 406, the method 400 proceeds where signals representing analyte levels in the CSF are sensed. The one or more sensors 204 within the adapter 108 may sense, at a plurality of time instances, a plurality of signals that represents an analyte level in the CSF. In some aspects of the present disclosure, these time instances may be five minutes apart, providing frequent measurements for continuous monitoring.
At step 408, the processing circuitry 206 determines readings based on the sensed signals corresponding to the plurality of time instances. The signal processing engine 300 may process the raw sensor signals to generate accurate glucose readings, applying necessary calibrations and corrections. These readings may be stored in the memory for future reference and analysis.
At step 410, the base value determination engine 302 determines a base analyte value from the plurality of readings. This base value may represent the patient's normal CSF glucose level and serve as a reference point for subsequent analysis. The base value may be stored in the memory for ongoing comparisons.
At step 412, the threshold determination engine 304 determines a threshold analyte value. The threshold analyte value may be a predefined fraction of the base analyte value, such as two-thirds of the base value. This threshold serves as a critical level below which there may be an increased risk of neurological issues. The threshold value may be stored in the memory and updated as needed.
At step 414, the trend analysis engine 306 performs a linear trend analysis on one or more recent readings from the plurality of readings. This analysis helps identify patterns and directions in the glucose level changes over time. The trend data may be stored in the memory for both short-term and long-term analysis.
At step 416, the prediction engine 308 predicts, based on the linear trend analysis, a future time at which the analyte level is going to reach the threshold value. This prediction provides an estimate of when the CSF glucose level may reach a potentially critical point. The prediction results may be stored in the memory for tracking and validation purposes.
At step 418, the method 400 evaluates whether the predicted future time falls within a predetermined timeframe. This evaluation determines the urgency of the situation and whether immediate action may be required.
At step 420, when the future time is within the predetermined timeframe, the alert generation engine 310 generates an alert. This alert may be visual, audible, or transmitted to healthcare providers' devices, signaling the need for clinical attention or intervention. The alert details and timestamp may be stored in the memory for audit and quality assurance purposes.
If the predicted future time is not within the predetermined timeframe, the method 400 continues monitoring by returning to collect additional CSF readings, ensuring continuous surveillance of the patient's CSF glucose levels.
In some aspects of the present disclosure, the method 400 may further include displaying a real-time graph of the plurality of readings, the base analyte value, and the threshold analyte value. This visual representation may aid healthcare providers in monitoring trends and making informed clinical decisions.
Furthermore, the method 400 may include updating the real-time graph to include a visual indicator of the predicted future time at which the analyte level will reach the threshold value. This feature enhances the predictive capabilities of the system, allowing for proactive patient management.
The alert generated by the system may include providing a visual alert on a display and an audible alarm, ensuring that critical information is communicated effectively to healthcare providers.
As used herein, "cerebrospinal fluid (CSF)" refers to the clear, colorless fluid that surrounds the brain and spinal cord, providing crucial protection, nutrient delivery, and waste removal for the central nervous system.
As used herein, "analyte" refers to a substance or chemical constituent that is determined in an analytical procedure. In the context of this disclosure, the primary analyte of interest is glucose in cerebrospinal fluid.
As used herein, "continuous glucose monitoring (CGM)" refers to the process of measuring glucose levels continuously or at frequent regular intervals, typically using a sensor that remains in place for an extended period.
The present disclosure provides a novel approach to CSF monitoring that may significantly improve the early detection and management of neurological conditions. By adapting CGM technology for use with CSF, the system enables continuous, real-time monitoring of glucose levels, potentially revolutionizing the care of patients with neurological disorders or those at risk of meningitis. The integration of data storage in the memory allows for comprehensive analysis and trend identification, further enhancing the system's diagnostic and predictive capabilities.
Thus, the system 100, the adapter 108, and the method 400 provide several significant technical advantages. The continuous, real-time monitoring of CSF glucose levels enables early detection of potential neurological issues, particularly meningitis, allowing for prompt intervention and improved patient outcomes. The integration of CGM technology with existing CSF drainage systems offers a non-invasive solution that minimizes additional procedural risks while maximizing diagnostic capabilities. The system's predictive modeling, based on linear trend analysis, provides healthcare providers with actionable insights and early warnings, enhancing clinical decision-making. The adapter's design, incorporating a particulate filter and one-way valve, ensures measurement accuracy and prevents backflow contamination, addressing key challenges in CSF monitoring. Furthermore, the system's ability to generate customizable alerts and display real-time graphical data enhances the efficiency of patient care in critical neurological settings. Lastly, the adaptability of the system to utilize off-the-shelf CGM sensors offers a cost-effective solution that can be readily implemented in various healthcare environments, potentially accelerating the adoption of advanced CSF monitoring techniques.
Aspects of the present disclosure are discussed here with reference to flowchart illustrations and block diagrams that depict methods, systems, and apparatus in accordance with various aspects of the present disclosure. Each block within these flowcharts and diagrams, as well as combinations of these blocks, can be executed by computer-readable program instructions. The various logical blocks, modules, circuits, and algorithm steps described in connection with the disclosed aspects may be implemented through electronic hardware, software, or a combination of both. To emphasize the interchangeability of hardware and software, the various components, blocks, modules, circuits, and steps are described generally in terms of their functionality. The decision to implement such functionality in hardware or software is dependent on the specific application and design constraints imposed on the overall system. Person having ordinary skill in the art can implement the described functionality in different ways depending on the particular application, without deviating from the scope of the present disclosure.
The flowcharts and block diagrams presented in the figures depict the architecture, functionality, and operation of potential implementations of systems, methods, and apparatus according to different aspects of the present disclosure. Each block in the flowcharts or diagrams may represent an engine, segment, or portion of instructions comprising one or more executable instructions to perform the specified logical function(s). In some alternative implementations, the order of functions within the blocks may differ from what is depicted. For instance, two blocks shown in sequence may be executed concurrently or in reverse order, depending on the required functionality. Each block, and combinations of blocks, can also be implemented using special-purpose hardware-based systems that perform the specified functions or tasks, or through a combination of specialized hardware and software instructions.
Although the preferred aspects have been detailed here, it should be apparent to those skilled in the relevant field that various modifications, additions, and substitutions can be made without departing from the scope of the disclosure. These variations are thus considered to be within the scope of the disclosure as defined in the following claims.
Features or functionalities described in certain example aspects may be combined and re-combined in or with other example aspects. Additionally, different aspects and elements of the disclosed example aspects may be similarly combined and re-combined. Further, some example aspects, individually or collectively, may form components of a larger system where other processes may take precedence or modify their application. Moreover, certain steps may be required before, after, or concurrently with the example aspects disclosed herein. It should be noted that any and all methods and processes disclosed herein can be performed in whole or in part by one or more entities or actors in any manner.
Although terms like "first," "second," etc., are used to describe various elements, components, regions, layers, and sections, these terms should not necessarily be interpreted as limiting. They are used solely to distinguish one element, component, region, layer, or section from another. For example, a "first" element discussed here could be referred to as a "second" element without departing from the teachings of the present disclosure.
The terminology used here is intended to describe specific example aspects and should not be considered as limiting the disclosure. The singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "includes," "comprising," and "including," as used herein, indicate the presence of stated features, steps, elements, or components, but do not exclude the presence or addition of other features, steps, elements, or components.
As used herein, the term "or" is intended to be inclusive, meaning that "X employs A or B" would be satisfied by X employing A, B, or both A and B. Unless specified otherwise or clearly understood from the context, this inclusive meaning applies to the term "or."
Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the relevant art. Terms should be interpreted consistently with their common usage in the context of the relevant art and should not be construed in an idealized or overly formal sense unless expressly defined here.
The terms "about" and "substantially," as used herein, refer to a variation of plus or minus 10% from the nominal value. This variation is always included in any given measure.
In cases where other disclosures are incorporated by reference and there is a conflict with the present disclosure, the present disclosure takes precedence to the extent of the conflict, or to provide a broader disclosure or definition of terms. If two disclosures conflict, the later-dated disclosure will take precedence.
The use of examples or exemplary language (such as "for example") is intended to illustrate aspects of the invention and should not be seen as limiting the scope unless otherwise claimed. No language in the specification should be interpreted as implying that any non-claimed element is essential to the practice of the invention.
While many alterations and modifications of the present invention will likely become apparent to those skilled in the art after reading this description, the specific aspects shown and described by way of illustration are not intended to be limiting in any way.
A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the scope of the disclosure. Accordingly, other implementations are within the scope of the following claims.

 
WE Claim:
1. An adapter (108) comprising:
a housing (200);
one or more sensors (204) disposed within the housing (200), wherein the one or more sensors (204) are configured to sense, at a plurality of time instances, a plurality of signals that represents an analyte level in Cerebrospinal fluid (CSF) collected by the drainage apparatus (102);
a connector (202) configured to be coupled to the drainage apparatus (102) to direct the flow of the CSF towards the one or more sensors (204); and
processing circuitry (206) that is coupled to the one or more sensors (204), and configured to:
determine a plurality of readings based on the plurality of sensed signals corresponding to the plurality of time instances;
determine a threshold analyte value, wherein the threshold analyte value is a predefined fraction of a base analyte value;
perform a linear trend analysis one or more recent readings from the plurality of readings;
predict, based on the linear trend analysis, a future time at which the analyte level is going to reach the threshold value; and
generate an alert when the future time is within a predetermined time frame.

2. The adapter (108) as claimed in claim 1, wherein the housing (200) is made up of a biocompatible material configured to minimize interference with the flow of the CSF.

3. The adapter (108) as claimed in claim 1, wherein the one or more sensors (204) are Continuous Glucose Monitoring (CGM) sensors.

4. The adapter (108) as claimed in claim 1, wherein the plurality of time instances are five minutes apart.

5. The adapter (108) as claimed in claim 1, wherein the connector (202) comprising a one-way valve (208) configured to prevent backflow of the CSF into the drainage apparatus (102).

6. The adapter (108) as claimed in claim 1, comprising a filter (210) disposed between the connector (202) and the one or more sensors (204), wherein the filter (210) is configured to remove particulates from the CSF before the CSF reaches the one or more sensors (204).

7. The adapter (108) as claimed in claim 1, wherein the analyte is glucose.

8. A system (100) comprising:
a drainage apparatus (102) configured to collect CSF from a user;
an adapter (108) configured to be coupled to the drainage apparatus (102), the adapter (108) comprising:
a housing (200);
one or more sensors (204) disposed within the housing (200), wherein the one or more sensors (204) are configured to sense, at a plurality of time instances, a plurality of signals that represents an analyte level in Cerebrospinal fluid (CSF) collected by the drainage apparatus (102);
a connector (202) configured to be coupled to the drainage apparatus (102) to direct the flow of the CSF towards the one or more sensors (204); and
processing circuitry (206) that is coupled to the one or more sensors (204), and configured to:
determine a plurality of readings based on the plurality of sensed signals corresponding to the plurality of time instances;
determine a threshold analyte value, wherein the threshold analyte value is a predefined fraction of a base analyte value;
perform a linear trend analysis one or more recent readings from the plurality of readings;
predict, based on the linear trend analysis, a future time at which the analyte level is going to reach the threshold value; and
generate an alert when the future time is within a predetermined time frame.

9. The system (100) as claimed in claim 8, wherein the housing (200) is made up of a biocompatible material configured to minimize interference with the flow of the CSF.

10. The system (100) as claimed in claim 8, wherein the one or more sensors (204) are CGM sensors.

11. The system (100) as claimed in claim 8, wherein the plurality of time instances are five minutes apart.

12. The system (100) as claimed in claim 8, wherein the connector (202) comprising a one-way valve (208) configured to prevent backflow of the CSF into the drainage apparatus (102).

13. The system (100) as claimed in claim 8, comprising a filter (210) disposed between the connector (202) and the one or more sensors (204), wherein the filter (210) is configured to remove particu
lates from the CSF before the CSF reaches the one or more sensors (204).

14. The system (100) as claimed in claim 8, wherein the analyte is glucose.

15. A method (400) comprising:
collecting cerebrospinal fluid (CSF) from a user using a drainage apparatus (102);
directing the flow of the CSF towards one or more sensors (204) disposed within a housing (200) of an adapter (108) coupled to the drainage apparatus (102);
sensing, by the one or more sensors (204) at a plurality of time instances, a plurality of signals that represents an analyte level in the CSF;
determining, by processing circuitry (206), a plurality of readings based on the plurality of sensed signals corresponding to the plurality of time instances;
determining, by the processing circuitry (206), a threshold analyte value, wherein the threshold analyte value is a predefined fraction of a base analyte value;
performing, by the processing circuitry (206), a linear trend analysis on one or more recent readings from the plurality of readings;
predicting, by the processing circuitry (206) based on the linear trend analysis, a future time at which the analyte level is going to reach the threshold value; and
generating, by the processing circuitry (206), an alert when the future time is within a predetermined time frame.

16. The method (400) as claimed in claim 15, wherein the housing (200) is made up of a biocompatible material configured to minimize interference with the flow of the CSF.

17. The method (400) as claimed in claim 15, wherein the one or more sensors (204) are CGM sensors.

18. The method (400) as claimed in claim 15, wherein the plurality of time instances are five minutes apart.

19. The method (400) as claimed in claim 15, further comprising preventing backflow of the CSF into the drainage apparatus (102) using a one-way valve (208) in a connector (202) of the adapter (108).

20. The method (400) as claimed in claim 15, further comprising filtering the CSF using a filter (210) disposed between a connector (202) of the adapter (108) and the one or more sensors (204) to remove particulates from the CSF before the CSF reaches the one or more sensors (204).

21. The method (400) as claimed in claim 15, wherein the analyte is glucose.

22. The method (400) as claimed in claim 15, comprising displaying a real-time graph of the plurality of readings, the base analyte value, and the threshold analyte value.

23. The method (400) as claimed in claim 22, comprising updating the real-time graph to include a visual indicator of the predicted future time at which the analyte level will reach the threshold value.

24. The method (400) as claimed in claim 15, wherein generating the alert comprising providing a visual alert on a display and an audible alarm.
, Claims:1. An adapter (108) comprising:
a housing (200);
one or more sensors (204) disposed within the housing (200), wherein the one or more sensors (204) are configured to sense, at a plurality of time instances, a plurality of signals that represents an analyte level in Cerebrospinal fluid (CSF) collected by the drainage apparatus (102);
a connector (202) configured to be coupled to the drainage apparatus (102) to direct the flow of the CSF towards the one or more sensors (204); and
processing circuitry (206) that is coupled to the one or more sensors (204), and configured to:
determine a plurality of readings based on the plurality of sensed signals corresponding to the plurality of time instances;
determine a threshold analyte value, wherein the threshold analyte value is a predefined fraction of a base analyte value;
perform a linear trend analysis one or more recent readings from the plurality of readings;
predict, based on the linear trend analysis, a future time at which the analyte level is going to reach the threshold value; and
generate an alert when the future time is within a predetermined time frame.

2. The adapter (108) as claimed in claim 1, wherein the housing (200) is made up of a biocompatible material configured to minimize interference with the flow of the CSF.

3. The adapter (108) as claimed in claim 1, wherein the one or more sensors (204) are Continuous Glucose Monitoring (CGM) sensors.

4. The adapter (108) as claimed in claim 1, wherein the plurality of time instances are five minutes apart.

5. The adapter (108) as claimed in claim 1, wherein the connector (202) comprising a one-way valve (208) configured to prevent backflow of the CSF into the drainage apparatus (102).

6. The adapter (108) as claimed in claim 1, comprising a filter (210) disposed between the connector (202) and the one or more sensors (204), wherein the filter (210) is configured to remove particulates from the CSF before the CSF reaches the one or more sensors (204).

7. The adapter (108) as claimed in claim 1, wherein the analyte is glucose.

8. A system (100) comprising:
a drainage apparatus (102) configured to collect CSF from a user;
an adapter (108) configured to be coupled to the drainage apparatus (102), the adapter (108) comprising:
a housing (200);
one or more sensors (204) disposed within the housing (200), wherein the one or more sensors (204) are configured to sense, at a plurality of time instances, a plurality of signals that represents an analyte level in Cerebrospinal fluid (CSF) collected by the drainage apparatus (102);
a connector (202) configured to be coupled to the drainage apparatus (102) to direct the flow of the CSF towards the one or more sensors (204); and
processing circuitry (206) that is coupled to the one or more sensors (204), and configured to:
determine a plurality of readings based on the plurality of sensed signals corresponding to the plurality of time instances;
determine a threshold analyte value, wherein the threshold analyte value is a predefined fraction of a base analyte value;
perform a linear trend analysis one or more recent readings from the plurality of readings;
predict, based on the linear trend analysis, a future time at which the analyte level is going to reach the threshold value; and
generate an alert when the future time is within a predetermined time frame.

9. The system (100) as claimed in claim 8, wherein the housing (200) is made up of a biocompatible material configured to minimize interference with the flow of the CSF.

10. The system (100) as claimed in claim 8, wherein the one or more sensors (204) are CGM sensors.

11. The system (100) as claimed in claim 8, wherein the plurality of time instances are five minutes apart.

12. The system (100) as claimed in claim 8, wherein the connector (202) comprising a one-way valve (208) configured to prevent backflow of the CSF into the drainage apparatus (102).

13. The system (100) as claimed in claim 8, comprising a filter (210) disposed between the connector (202) and the one or more sensors (204), wherein the filter (210) is configured to remove particu
lates from the CSF before the CSF reaches the one or more sensors (204).

14. The system (100) as claimed in claim 8, wherein the analyte is glucose.

15. A method (400) comprising:
collecting cerebrospinal fluid (CSF) from a user using a drainage apparatus (102);
directing the flow of the CSF towards one or more sensors (204) disposed within a housing (200) of an adapter (108) coupled to the drainage apparatus (102);
sensing, by the one or more sensors (204) at a plurality of time instances, a plurality of signals that represents an analyte level in the CSF;
determining, by processing circuitry (206), a plurality of readings based on the plurality of sensed signals corresponding to the plurality of time instances;
determining, by the processing circuitry (206), a threshold analyte value, wherein the threshold analyte value is a predefined fraction of a base analyte value;
performing, by the processing circuitry (206), a linear trend analysis on one or more recent readings from the plurality of readings;
predicting, by the processing circuitry (206) based on the linear trend analysis, a future time at which the analyte level is going to reach the threshold value; and
generating, by the processing circuitry (206), an alert when the future time is within a predetermined time frame.

16. The method (400) as claimed in claim 15, wherein the housing (200) is made up of a biocompatible material configured to minimize interference with the flow of the CSF.

17. The method (400) as claimed in claim 15, wherein the one or more sensors (204) are CGM sensors.

18. The method (400) as claimed in claim 15, wherein the plurality of time instances are five minutes apart.

19. The method (400) as claimed in claim 15, further comprising preventing backflow of the CSF into the drainage apparatus (102) using a one-way valve (208) in a connector (202) of the adapter (108).

20. The method (400) as claimed in claim 15, further comprising filtering the CSF using a filter (210) disposed between a connector (202) of the adapter (108) and the one or more sensors (204) to remove particulates from the CSF before the CSF reaches the one or more sensors (204).

21. The method (400) as claimed in claim 15, wherein the analyte is glucose.

22. The method (400) as claimed in claim 15, comprising displaying a real-time graph of the plurality of readings, the base analyte value, and the threshold analyte value.

23. The method (400) as claimed in claim 22, comprising updating the real-time graph to include a visual indicator of the predicted future time at which the analyte level will reach the threshold value.

24. The method (400) as claimed in claim 15, wherein generating the alert comprising providing a visual alert on a display and an audible alarm.